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



[[Page 1]]

          

                                         Title 42

                                      Public Health

                                ________________________

                                      Part 482 to End

                         Revised as of October 1, 2021

          Containing a codification of documents of general 
          applicability and future effect

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

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                            Table of Contents



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

  Title 42:
          Chapter IV--Centers for Medicare & Medicaid 
          Services, Department of Health and Human Services 
          (Continued)                                                3
          Chapter V--Office of Inspector General-Health Care, 
          Department of Health and Human Services                 1009
  Finding Aids:
      Table of CFR Titles and Chapters........................    1141
      Alphabetical List of Agencies Appearing in the CFR......    1161
      List of CFR Sections Affected...........................    1171

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

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 42 CFR 482.1 refers 
                       to title 42, part 482, 
                       section 1.

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

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                               EXPLANATION

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

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

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

LEGAL STATUS

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

HOW TO USE THE CODE OF FEDERAL REGULATIONS

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[[Page vi]]

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

[[Page vii]]

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







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                               THIS TITLE

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

    For this volume, Gabrielle E. Burns 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 part 482 to end)

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

chapter iv--Centers for Medicare & Medicaid Services, 
  Department of Health and Human Services (Continued).......         482

chapter v--Office of Inspector General-Health Care, 
  Department of Health and Human Services...................        1000

[[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, May 16, 2012.

                SUBCHAPTER G--STANDARDS AND CERTIFICATION
Part                                                                Page
482             Conditions of participation for hospitals...           5
483             Requirements for States and long term care 
                    facilities..............................          53
484             Home health services........................         155
485             Conditions of participation: Specialized 
                    providers...............................         190
486             Conditions for coverage of specialized 
                    services furnished by suppliers.........         245
488             Survey, certification, and enforcement 
                    procedures..............................         271
489             Provider agreements and supplier approval...         591
491             Certification of certain health facilities..         625
493             Laboratory requirements.....................         632
494             Conditions for coverage for end-stage renal 
                    disease facilities......................         755
495             Standards for the Electronic Health Record 
                    Technology Incentive Program............         775
498             Appeals procedures for determinations that 
                    affect participation in the Medicare 
                    program and for determinations that 
                    affect the participation of ICFs/IID and 
                    certain NFs in the Medicaid program.....         877
       SUBCHAPTER H--HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS
505             Establishment of the health care 
                    infrastructure improvement program......         896
510             Comprehensive care for joint replacement 
                    model...................................         899
512             Radiation oncology model and end stage renal 
                    disease treatment choices model.........         940

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513             Most favored nation (MFN) model.............         972
                   SUBCHAPTER I--BASIC HEALTH PROGRAM
600             Administration, eligibility, essential 
                    health benefits, performance standards, 
                    service delivery requirements, premium 
                    and cost sharing, allotments, and 
                    reconciliation..........................         989
601-699         [Reserved]

[[Page 5]]



                SUBCHAPTER G_STANDARDS AND CERTIFICATION





PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents



                      Subpart A_General Provisions

Sec.
482.1 Basis and scope.
482.2 Provision of emergency services by nonparticipating hospitals.

                        Subpart B_Administration

482.11 Condition of participation: Compliance with Federal, State and 
          local laws.
482.12 Condition of participation: Governing body.
482.13 Condition of participation: Patient's rights.
482.15 Condition of participation: Emergency preparedness.

                   Subpart C_Basic Hospital Functions

482.21 Condition of participation: Quality assessment and performance 
          improvement program.
482.22 Condition of participation: Medical staff.
482.23 Condition of participation: Nursing services.
482.24 Condition of participation: Medical record services.
482.25 Condition of participation: Pharmaceutical services.
482.26 Condition of participation: Radiologic services.
482.27 Condition of participation: Laboratory services.
482.28 Condition of participation: Food and dietetic services.
482.30 Condition of participation: Utilization review.
482.41 Condition of participation: Physical environment.
482.42 Condition of participation: Infection prevention and control and 
          antibiotic stewardship programs.
482.43 Condition of participation: Discharge planning.
482.45 Condition of participation: Organ, tissue, and eye procurement.

                  Subpart D_Optional Hospital Services

482.51 Condition of participation: Surgical services.
482.52 Condition of participation: Anesthesia services.
482.53 Condition of participation: Nuclear medicine services.
482.54 Condition of participation: Outpatient services.
482.55 Condition of participation: Emergency services.
482.56 Condition of participation: Rehabilitation services.
482.57 Condition of participation: Respiratory care services.
482.58 Special requirements for hospital providers of long-term care 
          services (``swing-beds'').

             Subpart E_Requirements for Specialty Hospitals

482.60 Special provisions applying to psychiatric hospitals.
482.61 Condition of participation: Special medical record requirements 
          for psychiatric hospitals.
482.62 Condition of participation: Special staff requirements for 
          psychiatric hospitals.
482.68 Special requirements for transplant programs.
482.70 Definitions.

               General Requirements for Transplant Centers

482.72 Condition of participation: OPTN Membership.
482.74 Condition of participation: Notification to CMS.
482.76 Condition of participation: Pediatric Transplants.
482.78 Condition of participation: Emergency preparedness for transplant 
          programs.

  Transplant Center Data Submission, Clinical Experience, and Outcome 
                              Requirements

482.80 Condition of participation: Data submission, clinical experience, 
          and outcome requirements for initial approval of transplant 
          programs.

                 Transplant Program Process Requirements

482.90 Condition of participation: Patient and living donor selection.
482.92 Condition of participation: Organ recovery and receipt.
482.94 Condition of participation: Patient and living donor management.
482.96 Condition of participation: Quality assessment and performance 
          improvement (QAPI).
482.98 Condition of participation: Human resources.
482.100 Condition of participation: Organ procurement.
482.102 Condition of participation: Patient and living donor rights.

[[Page 6]]

482.104 Condition of participation: Additional requirements for kidney 
          transplant programs.

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise 
noted.

    Source: 51 FR 22042, June 17, 1986, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 482.1  Basis and scope.

    (a) Statutory basis. (1) Section 1861(e) of the Act provides that--
    (i) Hospitals participating in Medicare must meet certain specified 
requirements; and
    (ii) The Secretary may impose additional requirements if they are 
found necessary in the interest of the health and safety of the 
individuals who are furnished services in hospitals.
    (2) Section 1861(f) of the Act provides that an institution 
participating in Medicare as a psychiatric hospital must meet certain 
specified requirements imposed on hospitals under section 1861(e), must 
be primarily engaged in providing, by or under the supervision of a 
physician, psychiatric services for the diagnosis and treatment of 
mentally ill persons, must maintain clinical records and other records 
that the Secretary finds necessary, and must meet staffing requirements 
that the Secretary finds necessary to carry out an active program of 
treatment for individuals who are furnished services in the hospital. A 
distinct part of an institution can participate as a psychiatric 
hospital if the institution meets the specified 1861(e) requirements and 
is primarily engaged in providing psychiatric services, and if the 
distinct part meets the records and staffing requirements that the 
Secretary finds necessary.
    (3) Sections 1861(k) and 1902(a)(30) of the Act provide that 
hospitals participating in Medicare and Medicaid must have a utilization 
review plan that meets specified requirements.
    (4) Section 1883 of the Act sets forth the requirements for 
hospitals that provide long term care under an agreement with the 
Secretary.
    (5) Section 1905(a) of the Act provides that ``medical assistance'' 
(Medicaid) payments may be applied to various hospital services. 
Regulations interpreting those provisions specify that hospitals 
receiving payment under Medicaid must meet the requirements for 
participation in Medicare (except in the case of medical supervision of 
nurse-midwife services. See Sec. Sec. 440.10 and 440.165 of this 
chapter.).
    (b) Scope. Except as provided in subpart A of part 488 of this 
chapter, the provisions of this part serve as the basis of survey 
activities for the purpose of determining whether a hospital qualifies 
for a provider agreement under Medicare and Medicaid.

[51 FR 22042, June 17, 1986, as amended at 60 FR 50442, Sept. 29, 1995]



Sec. 482.2  Provision of emergency services by nonparticipating 
hospitals.

    (a) The services of an institution that does not have an agreement 
to participate in the Medicare program may, nevertheless, be reimbursed 
under the program if--
    (1) The services are emergency services; and
    (2) The institution meets the requirements of section 1861(e) (1) 
through (5) and (7) of the Act. Rules applicable to emergency services 
furnished by nonparticipating hospitals are set forth in subpart G of 
part 424 of this chapter.
    (b) Section 440.170(e) of this chapter defines emergency hospital 
services for purposes of Medicaid reimbursement.

[51 FR 22042, June 17, 1986, as amended at 53 FR 6648, Mar. 2, 1988]



                        Subpart B_Administration



Sec. 482.11  Condition of participation: Compliance with Federal, 
State and local laws.

    (a) The hospital must be in compliance with applicable Federal laws 
related to the health and safety of patients.
    (b) The hospital must be--
    (1) Licensed; or
    (2) Approved as meeting standards for licensing established by the 
agency of the State or locality responsible for licensing hospitals.
    (c) The hospital must assure that personnel are licensed or meet 
other applicable standards that are required by State or local laws.

[[Page 7]]



Sec. 482.12  Condition of participation: Governing body.

    There must be an effective governing body that is legally 
responsible for the conduct of the hospital. If a hospital does not have 
an organized governing body, the persons legally responsible for the 
conduct of the hospital must carry out the functions specified in this 
part that pertain to the governing body.
    (a) Standard: Medical staff. The governing body must:
    (1) Determine, in accordance with State law, which categories of 
practitioners are eligible candidates for appointment to the medical 
staff;
    (2) Appoint members of the medical staff after considering the 
recommendations of the existing members of the medical staff;
    (3) Assure that the medical staff has bylaws;
    (4) Approve medical staff bylaws and other medical staff rules and 
regulations;
    (5) Ensure that the medical staff is accountable to the governing 
body for the quality of care provided to patients;
    (6) Ensure the criteria for selection are individual character, 
competence, training, experience, and judgment; and
    (7) Ensure that under no circumstances is the accordance of staff 
membership or professional privileges in the hospital dependent solely 
upon certification, fellowship, or membership in a specialty body or 
society.
    (8) Ensure that, when telemedicine services are furnished to the 
hospital's patients through an agreement with a distant-site hospital, 
the agreement is written and that it specifies that it is the 
responsibility of the governing body of the distant-site hospital to 
meet the requirements in paragraphs (a)(1) through (a)(7) of this 
section with regard to the distant-site hospital's physicians and 
practitioners providing telemedicine services. The governing body of the 
hospital whose patients are receiving the telemedicine services may, in 
accordance with Sec. 482.22(a)(3) of this part, grant privileges based 
on its medical staff recommendations that rely on information provided 
by the distant-site hospital.
    (9) Ensure that when telemedicine services are furnished to the 
hospital's patients through an agreement with a distant-site 
telemedicine entity, the written agreement specifies that the distant-
site telemedicine entity is a contractor of services to the hospital and 
as such, in accordance with Sec. 482.12(e), furnishes the contracted 
services in a manner that permits the hospital to comply with all 
applicable conditions of participation for the contracted services, 
including, but not limited to, the requirements in paragraphs (a)(1) 
through (a)(7) of this section with regard to the distant-site 
telemedicine entity's physicians and practitioners providing 
telemedicine services. The governing body of the hospital whose patients 
are receiving the telemedicine services may, in accordance with Sec. 
482.22(a)(4) of this part, grant privileges to physicians and 
practitioners employed by the distant-site telemedicine entity based on 
such hospital's medical staff recommendations; such staff 
recommendations may rely on information provided by the distant-site 
telemedicine entity.
    (10) Consult directly with the individual assigned the 
responsibility for the organization and conduct of the hospital's 
medical staff, or his or her designee. At a minimum, this direct 
consultation must occur periodically throughout the fiscal or calendar 
year and include discussion of matters related to the quality of medical 
care provided to patients of the hospital. For a multi-hospital system 
using a single governing body, the single multi-hospital system 
governing body must consult directly with the individual responsible for 
the organized medical staff (or his or her designee) of each hospital 
within its system in addition to the other requirements of this 
paragraph (a).
    (b) Standard: Chief executive officer. The governing body must 
appoint a chief executive officer who is responsible for managing the 
hospital.
    (c) Standard: Care of patients. In accordance with hospital policy, 
the governing body must ensure that the following requirements are met:
    (1) Every Medicare patient is under the care of:

[[Page 8]]

    (i) A doctor of medicine or osteopathy (This provision is not to be 
construed to limit the authority of a doctor of medicine or osteopathy 
to delegate tasks to other qualified health care personnel to the extent 
recognized under State law or a State's regulatory mechanism.);
    (ii) A doctor of dental surgery or dental medicine who is legally 
authorized to practice dentistry by the State and who is acting within 
the scope of his or her license;
    (iii) A doctor of podiatric medicine, but only with respect to 
functions which he or she is legally authorized by the State to perform;
    (iv) A doctor of optometry who is legally authorized to practice 
optometry by the State in which he or she practices;
    (v) A chiropractor who is licensed by the State or legally 
authorized to perform the services of a chiropractor, but only with 
respect to treatment by means of manual manipulation of the spine to 
correct a subluxation demonstrated by x-ray to exist; and
    (vi) A clinical psychologist as defined in Sec. 410.71 of this 
chapter, but only with respect to clinical psychologist services as 
defined in Sec. 410.71 of this chapter and only to the extent permitted 
by State law.
    (2) Patients are admitted to the hospital only on the recommendation 
of a licensed practitioner permitted by the State to admit patients to a 
hospital. If a Medicare patient is admitted by a practitioner not 
specified in paragraph (c)(1) of this section, that patient is under the 
care of a doctor of medicine or osteopathy.
    (3) A doctor of medicine or osteopathy is on duty or on call at all 
times.
    (4) A doctor of medicine or osteopathy is responsible for the care 
of each Medicare patient with respect to any medical or psychiatric 
problem that--
    (i) is present on admission or develops during hospitalization; and
    (ii) Is not specifically within the scope of practice of a doctor of 
dental surgery, dental medicine, podiatric medicine, or optometry; a 
chiropractor; or clinical psychologist, as that scope is--
    (A) Defined by the medical staff;
    (B) Permitted by State law; and
    (C) Limited, under paragraph (c)(1)(v) of this section, with respect 
to chiropractors.
    (d) Standard: Institutional plan and budget. The institution must 
have an overall institutional plan that meets the following conditions:
    (1) The plan must include an annual operating budget that is 
prepared according to generally accepted accounting principles.
    (2) The budget must include all anticipated income and expenses. 
This provision does not require that the budget identify item by item 
the components of each anticipated income or expense.
    (3) The plan must provide for capital expenditures for at least a 3-
year period, including the year in which the operating budget specified 
in paragraph (d)(2) of this section is applicable.
    (4) The plan must include and identify in detail the objective of, 
and the anticipated sources of financing for, each anticipated capital 
expenditure in excess of $600,000 (or a lesser amount that is 
established, in accordance with section 1122(g)(1) of the Act, by the 
State in which the hospital is located) that relates to any of the 
following:
    (i) Acquisition of land;
    (ii) Improvement of land, buildings, and equipment; or
    (iii) The replacement, modernization, and expansion of buildings and 
equipment.
    (5) The plan must be submitted for review to the planning agency 
designated in accordance with section 1122(b) of the Act, or if an 
agency is not designated, to the appropriate health planning agency in 
the State. (See part 100 of this title.) A capital expenditure is not 
subject to section 1122 review if 75 percent of the health care 
facility's patients who are expected to use the service for which the 
capital expenditure is made are individuals enrolled in a health 
maintenance organization (HMO) or competitive medical plan (CMP) that 
meets the requirements of section 1876(b) of the Act, and if the 
Department determines that the capital expenditure is for services and 
facilities that are needed by the HMO or CMP in order to operate 
efficiently and

[[Page 9]]

economically and that are not otherwise readily accessible to the HMO or 
CMP because--
    (i) The facilities do not provide common services at the same site;
    (ii) The facilities are not available under a contract of reasonable 
duration;
    (iii) Full and equal medical staff privileges in the facilities are 
not available;
    (iv) Arrangements with these facilities are not administratively 
feasible; or
    (v) The purchase of these services is more costly than if the HMO or 
CMP provided the services directly.
    (6) The plan must be reviewed and updated annually.
    (7) The plan must be prepared--
    (i) Under the direction of the governing body; and
    (ii) By a committee consisting of representatives of the governing 
body, the administrative staff, and the medical staff of the 
institution.
    (e) Standard: Contracted services. The governing body must be 
responsible for services furnished in the hospital whether or not they 
are furnished under contracts. The governing body must ensure that a 
contractor of services (including one for shared services and joint 
ventures) furnishes services that permit the hospital to comply with all 
applicable conditions of participation and standards for the contracted 
services.
    (1) The governing body must ensure that the services performed under 
a contract are provided in a safe and effective manner.
    (2) The hospital must maintain a list of all contracted services, 
including the scope and nature of the services provided.
    (f) Standard: Emergency services. (1) If emergency services are 
provided at the hospital, the hospital must comply with the requirements 
of Sec. 482.55.
    (2) If emergency services are not provided at the hospital, the 
governing body must assure that the medical staff has written policies 
and procedures for appraisal of emergencies, initial treatment, and 
referral when appropriate.
    (3) If emergency services are provided at the hospital but are not 
provided at one or more off-campus departments of the hospital, the 
governing body of the hospital must assure that the medical staff has 
written policies and procedures in effect with respect to the off-campus 
department(s) for appraisal of emergencies and referral when 
appropriate.

[51 FR 22042, June 17, 1986; 51 FR 27847, Aug. 4, 1986, as amended at 53 
FR 6549, Mar. 1, 1988; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1, 
1991; 56 FR 23022, May 20, 1991; 59 FR 46514, Sept. 8, 1994; 63 FR 
20130, Apr. 23, 1998; 63 FR 33874, June 22, 1998; 68 FR 53262, Sept. 9, 
2003; 76 FR 25562, May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, 
May 12, 2014]



Sec. 482.13  Condition of participation: Patient's rights.

    A hospital must protect and promote each patient's rights.
    (a) Standard: Notice of rights. (1) A hospital must inform each 
patient, or when appropriate, the patient's representative (as allowed 
under State law), of the patient's rights, in advance of furnishing or 
discontinuing patient care whenever possible.
    (2) The hospital must establish a process for prompt resolution of 
patient grievances and must inform each patient whom to contact to file 
a grievance. The hospital's governing body must approve and be 
responsible for the effective operation of the grievance process and 
must review and resolve grievances, unless it delegates the 
responsibility in writing to a grievance committee. The grievance 
process must include a mechanism for timely referral of patient concerns 
regarding quality of care or premature discharge to the appropriate 
Utilization and Quality Control Quality Improvement Organization. At a 
minimum:
    (i) The hospital must establish a clearly explained procedure for 
the submission of a patient's written or verbal grievance to the 
hospital.
    (ii) The grievance process must specify time frames for review of 
the grievance and the provision of a response.
    (iii) In its resolution of the grievance, the hospital must provide 
the patient with written notice of its decision that contains the name 
of the hospital contact person, the steps taken on behalf of the patient 
to investigate the grievance, the results of the grievance process, and 
the date of completion.

[[Page 10]]

    (b) Standard: Exercise of rights. (1) The patient has the right to 
participate in the development and implementation of his or her plan of 
care.
    (2) The patient or his or her representative (as allowed under State 
law) has the right to make informed decisions regarding his or her care. 
The patient's rights include being informed of his or her health status, 
being involved in care planning and treatment, and being able to request 
or refuse treatment. This right must not be construed as a mechanism to 
demand the provision of treatment or services deemed medically 
unnecessary or inappropriate.
    (3) The patient has the right to formulate advance directives and to 
have hospital staff and practitioners who provide care in the hospital 
comply with these directives, in accordance with Sec. 489.100 of this 
part (Definition), Sec. 489.102 of this part (Requirements for 
providers), and Sec. 489.104 of this part (Effective dates).
    (4) The patient has the right to have a family member or 
representative of his or her choice and his or her own physician 
notified promptly of his or her admission to the hospital.
    (c) Standard: Privacy and safety. (1) The patient has the right to 
personal privacy.
    (2) The patient has the right to receive care in a safe setting.
    (3) The patient has the right to be free from all forms of abuse or 
harassment.
    (d) Standard: Confidentiality of patient records. (1) The patient 
has the right to the confidentiality of his or her clinical records.
    (2) The patient has the right to access their medical records, 
including current medical records, upon an oral or written request, in 
the form and format requested by the individual, if it is readily 
producible in such form and format (including in an electronic form or 
format when such medical records are maintained electronically); or, if 
not, in a readable hard copy form or such other form and format as 
agreed to by the facility and the individual, and within a reasonable 
time frame. The hospital must not frustrate the legitimate efforts of 
individuals to gain access to their own medical records and must 
actively seek to meet these requests as quickly as its record keeping 
system permits.
    (e) Standard: Restraint or seclusion. All patients have the right to 
be free from physical or mental abuse, and corporal punishment. All 
patients have the right to be free from restraint or seclusion, of any 
form, imposed as a means of coercion, discipline, convenience, or 
retaliation by staff. Restraint or seclusion may only be imposed to 
ensure the immediate physical safety of the patient, a staff member, or 
others and must be discontinued at the earliest possible time.
    (1) Definitions. (i) A restraint is--
    (A) Any manual method, physical or mechanical device, material, or 
equipment that immobilizes or reduces the ability of a patient to move 
his or her arms, legs, body, or head freely; or
    (B) A drug or medication when it is used as a restriction to manage 
the patient's behavior or restrict the patient's freedom of movement and 
is not a standard treatment or dosage for the patient's condition.
    (C) A restraint does not include devices, such as orthopedically 
prescribed devices, surgical dressings or bandages, protective helmets, 
or other methods that involve the physical holding of a patient for the 
purpose of conducting routine physical examinations or tests, or to 
protect the patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort).
    (ii) Seclusion is the involuntary confinement of a patient alone in 
a room or area from which the patient is physically prevented from 
leaving. Seclusion may only be used for the management of violent or 
self-destructive behavior.
    (2) Restraint or seclusion may only be used when less restrictive 
interventions have been determined to be ineffective to protect the 
patient a staff member or others from harm.
    (3) The type or technique of restraint or seclusion used must be the 
least restrictive intervention that will be effective to protect the 
patient, a staff member, or others from harm.
    (4) The use of restraint or seclusion must be--

[[Page 11]]

    (i) In accordance with a written modification to the patient's plan 
of care; and
    (ii) Implemented in accordance with safe and appropriate restraint 
and seclusion techniques as determined by hospital policy in accordance 
with State law.
    (5) The use of restraint or seclusion must be in accordance with the 
order of a physician or other licensed practitioner who is responsible 
for the care of the patient and authorized to order restraint or 
seclusion by hospital policy in accordance with State law.
    (6) Orders for the use of restraint or seclusion must never be 
written as a standing order or on an as needed basis (PRN).
    (7) The attending physician must be consulted as soon as possible if 
the attending physician did not order the restraint or seclusion.
    (8) Unless superseded by State law that is more restrictive--
    (i) Each order for restraint or seclusion used for the management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others may only be 
renewed in accordance with the following limits for up to a total of 24 
hours:
    (A) 4 hours for adults 18 years of age or older;
    (B) 2 hours for children and adolescents 9 to 17 years of age; or
    (C) 1 hour for children under 9 years of age; and
    (ii) After 24 hours, before writing a new order for the use of 
restraint or seclusion for the management of violent or self-destructive 
behavior, a physician or other licensed practitioner who is responsible 
for the care of the patient and authorized to order restraint or 
seclusion by hospital policy in accordance with State law must see and 
assess the patient.
    (iii) Each order for restraint used to ensure the physical safety of 
the non-violent or non-self-destructive patient may be renewed as 
authorized by hospital policy.
    (9) Restraint or seclusion must be discontinued at the earliest 
possible time, regardless of the length of time identified in the order.
    (10) The condition of the patient who is restrained or secluded must 
be monitored by a physician, other licensed practitioner, or trained 
staff that have completed the training criteria specified in paragraph 
(f) of this section at an interval determined by hospital policy.
    (11) Physician and other licensed practitioner training requirements 
must be specified in hospital policy. At a minimum, physicians and other 
licensed practitioners authorized to order restraint or seclusion by 
hospital policy in accordance with State law must have a working 
knowledge of hospital policy regarding the use of restraint or 
seclusion.
    (12) When restraint or seclusion is used for the management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others, the patient 
must be seen face-to-face within 1 hour after the initiation of the 
intervention--
    (i) By a--
    (A) Physician or other licensed practitioner.
    (B) Registered nurse who has been trained in accordance with the 
requirements specified in paragraph (f) of this section.
    (ii) To evaluate--
    (A) The patient's immediate situation;
    (B) The patient's reaction to the intervention;
    (C) The patient's medical and behavioral condition; and
    (D) The need to continue or terminate the restraint or seclusion.
    (13) States are free to have requirements by statute or regulation 
that are more restrictive than those contained in paragraph (e)(12)(i) 
of this section.
    (14) If the face-to-face evaluation specified in paragraph (e)(12) 
of this section is conducted by a trained registered nurse, the trained 
registered nurse must consult the attending physician or other licensed 
practitioner who is responsible for the care of the patient as soon as 
possible after the completion of the 1-hour face-to-face evaluation.

[[Page 12]]

    (15) All requirements specified under this paragraph are applicable 
to the simultaneous use of restraint and seclusion. Simultaneous 
restraint and seclusion use is only permitted if the patient is 
continually monitored--
    (i) Face-to-face by an assigned, trained staff member; or
    (ii) By trained staff using both video and audio equipment. This 
monitoring must be in close proximity to the patient.
    (16) When restraint or seclusion is used, there must be 
documentation in the patient's medical record of the following:
    (i) The 1-hour face-to-face medical and behavioral evaluation if 
restraint or seclusion is used to manage violent or self-destructive 
behavior;
    (ii) A description of the patient's behavior and the intervention 
used;
    (iii) Alternatives or other less restrictive interventions attempted 
(as applicable);
    (iv) The patient's condition or symptom(s) that warranted the use of 
the restraint or seclusion; and
    (v) The patient's response to the intervention(s) used, including 
the rationale for continued use of the intervention.
    (f) Standard: Restraint or seclusion: Staff training requirements. 
The patient has the right to safe implementation of restraint or 
seclusion by trained staff.
    (1) Training intervals. Staff must be trained and able to 
demonstrate competency in the application of restraints, implementation 
of seclusion, monitoring, assessment, and providing care for a patient 
in restraint or seclusion--
    (i) Before performing any of the actions specified in this 
paragraph;
    (ii) As part of orientation; and
    (iii) Subsequently on a periodic basis consistent with hospital 
policy.
    (2) Training content. The hospital must require appropriate staff to 
have education, training, and demonstrated knowledge based on the 
specific needs of the patient population in at least the following:
    (i) Techniques to identify staff and patient behaviors, events, and 
environmental factors that may trigger circumstances that require the 
use of a restraint or seclusion.
    (ii) The use of nonphysical intervention skills.
    (iii) Choosing the least restrictive intervention based on an 
individualized assessment of the patient's medical, or behavioral status 
or condition.
    (iv) The safe application and use of all types of restraint or 
seclusion used in the hospital, including training in how to recognize 
and respond to signs of physical and psychological distress (for 
example, positional asphyxia);
    (v) Clinical identification of specific behavioral changes that 
indicate that restraint or seclusion is no longer necessary.
    (vi) Monitoring the physical and psychological well-being of the 
patient who is restrained or secluded, including but not limited to, 
respiratory and circulatory status, skin integrity, vital signs, and any 
special requirements specified by hospital policy associated with the 1-
hour face-to-face evaluation.
    (vii) The use of first aid techniques and certification in the use 
of cardiopulmonary resuscitation, including required periodic 
recertification.
    (3) Trainer requirements. Individuals providing staff training must 
be qualified as evidenced by education, training, and experience in 
techniques used to address patients' behaviors.
    (4) Training documentation. The hospital must document in the staff 
personnel records that the training and demonstration of competency were 
successfully completed.
    (g) Standard: Death reporting requirements: Hospitals must report 
deaths associated with the use of seclusion or restraint.
    (1) With the exception of deaths described under paragraph (g)(2) of 
this section, the hospital must report the following information to CMS 
by telephone, facsimile, or electronically, as determined by CMS, no 
later than the close of business on the next business day following 
knowledge of the patient's death:
    (i) Each death that occurs while a patient is in restraint or 
seclusion.
    (ii) Each death that occurs within 24 hours after the patient has 
been removed from restraint or seclusion.
    (iii) Each death known to the hospital that occurs within 1 week 
after

[[Page 13]]

restraint or seclusion where it is reasonable to assume that use of 
restraint or placement in seclusion contributed directly or indirectly 
to a patient's death, regardless of the type(s) of restraint used on the 
patient during this time. ``Reasonable to assume'' in this context 
includes, but is not limited to, deaths related to restrictions of 
movement for prolonged periods of time, or death related to chest 
compression, restriction of breathing, or asphyxiation.
    (2) When no seclusion has been used and when the only restraints 
used on the patient are those applied exclusively to the patient's 
wrist(s), and which are composed solely of soft, non-rigid, cloth-like 
materials, the hospital staff must record in an internal log or other 
system, the following information:
    (i) Any death that occurs while a patient is in such restraints.
    (ii) Any death that occurs within 24 hours after a patient has been 
removed from such restraints.
    (3) The staff must document in the patient's medical record the date 
and time the death was:
    (i) Reported to CMS for deaths described in paragraph (g)(1) of this 
section; or
    (ii) Recorded in the internal log or other system for deaths 
described in paragraph (g)(2) of this section.
    (4) For deaths described in paragraph (g)(2) of this section, 
entries into the internal log or other system must be documented as 
follows:
    (i) Each entry must be made not later than seven days after the date 
of death of the patient.
    (ii) Each entry must document the patient's name, date of birth, 
date of death, name of attending physician or other licensed 
practitioner who is responsible for the care of the patient, medical 
record number, and primary diagnosis(es).
    (iii) The information must be made available in either written or 
electronic form to CMS immediately upon request.
    (h) Standard: Patient visitation rights. A hospital must have 
written policies and procedures regarding the visitation rights of 
patients, including those setting forth any clinically necessary or 
reasonable restriction or limitation that the hospital may need to place 
on such rights and the reasons for the clinical restriction or 
limitation. A hospital must meet the following requirements:
    (1) Inform each patient (or support person, where appropriate) of 
his or her visitation rights, including any clinical restriction or 
limitation on such rights, when he or she is informed of his or her 
other rights under this section.
    (2) Inform each patient (or support person, where appropriate) of 
the right, subject to his or her consent, to receive the visitors whom 
he or she designates, including, but not limited to, a spouse, a 
domestic partner (including a same-sex domestic partner), another family 
member, or a friend, and his or her right to withdraw or deny such 
consent at any time.
    (3) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, gender 
identity, sexual orientation, or disability.
    (4) Ensure that all visitors enjoy full and equal visitation 
privileges consistent with patient preferences.

[71 FR 71426, Dec. 8, 2006, as amended at 75 FR 70844, Nov. 19, 2010; 77 
FR 29074, May 16, 2012; 84 FR 51817, 51882, Sept. 30, 2019]



Sec. 482.15  Condition of participation: Emergency preparedness.

    The hospital must comply with all applicable Federal, State, and 
local emergency preparedness requirements. The hospital must develop and 
maintain a comprehensive emergency preparedness program that meets the 
requirements of this section, utilizing an all-hazards approach. The 
emergency preparedness program must include, but not be limited to, the 
following elements:
    (a) Emergency plan. The hospital 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.

[[Page 14]]

    (3) Address patient population, including, but not limited to, 
persons at-risk; the type of services the hospital 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 hospital must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect patient health and safety and for the 
safe and sanitary storage of provisions.
    (B) Emergency lighting.
    (C) Fire detection, extinguishing, and alarm systems.
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
patients in the hospital's care during an emergency. If on-duty staff 
and sheltered patients are relocated during the emergency, the hospital 
must document the specific name and location of the receiving facility 
or other location.
    (3) Safe evacuation from the hospital, 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 patients, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (6) The use of volunteers in an emergency and other emergency 
staffing strategies, including the process and 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 hospitals and other 
providers to receive patients in the event of limitations or cessation 
of operations to maintain the continuity of services to hospital 
patients.
    (8) The role of the hospital 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.
    (c) Communication plan. The hospital 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) Patients' physicians.
    (iv) Other hospitals and CAHs
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) Hospital's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.

[[Page 15]]

    (4) A method for sharing information and medical documentation for 
patients under the hospital'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 patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the hospital'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 hospital 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 hospital must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected role.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the hospital must conduct training on the updated 
policies and procedures.
    (2) Testing. The hospital must conduct exercises to test the 
emergency plan at least twice per year. The hospital must do all of 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 hospital experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the hospital 
is exempt from engaging in its next required full-scale community-based 
exercise 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 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 hospital's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
hospital's emergency plan, as needed.
    (e) Emergency and standby power systems. The hospital must implement 
emergency and standby power systems based on the emergency plan set 
forth in paragraph (a) of this section and in the policies and 
procedures plan set forth in paragraphs (b)(1)(i) and (ii) of this 
section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in 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), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The hospital must 
implement the emergency power system inspection, testing, and 
maintenance requirements found in the Health Care Facilities Code, NFPA 
110, and Life Safety Code.

[[Page 16]]

    (3) Emergency generator fuel. Hospitals that maintain an onsite fuel 
source to power emergency generators must have a plan for how it will 
keep emergency power systems operational during the emergency, unless it 
evacuates.
    (f) Integrated healthcare systems. If a hospital 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 hospital 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, 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.
    (g) Transplant hospitals. If a hospital has one or more transplant 
programs (as defined in Sec. 482.70)--
    (1) A representative from each transplant program must be included 
in the development and maintenance of the hospital's emergency 
preparedness program; and
    (2) The hospital must develop and maintain mutually agreed upon 
protocols that address the duties and responsibilities of the hospital, 
each transplant program, and the OPO for the DSA where the hospital is 
situated, unless the hospital has been granted a waiver to work with 
another OPO, during an emergency.
    (h) 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 obtain the material from the sources listed below. 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, Health Care Facilities Code, 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (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.

[[Page 17]]

    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

[81 FR 64028, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016; 84 FR 51817, 
Sept. 30, 2019]



                   Subpart C_Basic Hospital Functions



Sec. 482.21  Condition of participation: Quality assessment and
performance improvement program.

    The hospital must develop, implement, and maintain an effective, 
ongoing, hospital-wide, data-driven quality assessment and performance 
improvement program. The hospital's governing body must ensure that the 
program reflects the complexity of the hospital's organization and 
services; involves all hospital departments and services (including 
those services furnished under contract or arrangement); and focuses on 
indicators related to improved health outcomes and the prevention and 
reduction of medical errors. The hospital must maintain and demonstrate 
evidence of its QAPI program for review by CMS.
    (a) Standard: Program scope. (1) The program must include, but not 
be limited to, an ongoing program that shows measurable improvement in 
indicators for which there is evidence that it will improve health 
outcomes and identify and reduce medical errors.
    (2) The hospital must measure, analyze, and track quality 
indicators, including adverse patient events, and other aspects of 
performance that assess processes of care, hospital service and 
operations.
    (b) Standard: Program data. (1) The program must incorporate quality 
indicator data including patient care data, and other relevant data such 
as data submitted to or received from Medicare quality reporting and 
quality performance programs, including but not limited to data related 
to hospital readmissions and hospital-acquired conditions.
    (2) The hospital must use the data collected to--
    (i) Monitor the effectiveness and safety of services and quality of 
care; and
    (ii) Identify opportunities for improvement and changes that will 
lead to improvement.
    (3) The frequency and detail of data collection must be specified by 
the hospital's governing body.
    (c) Standard: Program activities. (1) The hospital must set 
priorities for its performance improvement activities that--
    (i) Focus on high-risk, high-volume, or problem-prone areas;
    (ii) Consider the incidence, prevalence, and severity of problems in 
those areas; and
    (iii) Affect health outcomes, patient safety, and quality of care.
    (2) Performance improvement activities must track medical errors and 
adverse patient events, analyze their causes, and implement preventive 
actions and mechanisms that include feedback and learning throughout the 
hospital.
    (3) The hospital must take actions aimed at performance improvement 
and, after implementing those actions, the hospital must measure its 
success, and track performance to ensure that improvements are 
sustained.
    (d) Standard: Performance improvement projects. As part of its 
quality assessment and performance improvement program, the hospital 
must conduct performance improvement projects.
    (1) The number and scope of distinct improvement projects conducted 
annually must be proportional to the scope and complexity of the 
hospital's services and operations.
    (2) A hospital may, as one of its projects, develop and implement an 
information technology system explicitly designed to improve patient 
safety and quality of care. This project, in its initial stage of 
development, does not need to demonstrate measurable improvement in 
indicators related to health outcomes.
    (3) The hospital must document what quality improvement projects are 
being conducted, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.

[[Page 18]]

    (4) A hospital is not required to participate in a QIO cooperative 
project, but its own projects are required to be of comparable effort.
    (e) Standard: Executive responsibilities. The hospital's governing 
body (or organized group or individual who assumes full legal authority 
and responsibility for operations of the hospital), medical staff, and 
administrative officials are responsible and accountable for ensuring 
the following:
    (1) That an ongoing program for quality improvement and patient 
safety, including the reduction of medical errors, is defined, 
implemented, and maintained.
    (2) That the hospital-wide quality assessment and performance 
improvement efforts address priorities for improved quality of care and 
patient safety; and that all improvement actions are evaluated.
    (3) That clear expectations for safety are established.
    (4) That adequate resources are allocated for measuring, assessing, 
improving, and sustaining the hospital's performance and reducing risk 
to patients.
    (5) That the determination of the number of distinct improvement 
projects is conducted annually.
    (f) Standard: Unified and integrated QAPI program for multi-hospital 
systems. If a hospital is part of a hospital system consisting of 
multiple separately certified hospitals using a system governing body 
that is legally responsible for the conduct of two or more hospitals, 
the system governing body can elect to have a unified and integrated 
QAPI program for all of its member hospitals after determining that such 
a decision is in accordance with all applicable State and local laws. 
The system governing body is responsible and accountable for ensuring 
that each of its separately certified hospitals meets all of the 
requirements of this section. Each separately certified hospital subject 
to the system governing body must demonstrate that:
    (1) The unified and integrated QAPI program is established in a 
manner that takes into account each member hospital's unique 
circumstances and any significant differences in patient populations and 
services offered in each hospital; and
    (2) The unified and integrated QAPI program establishes and 
implements policies and procedures to ensure that the needs and concerns 
of each of its separately certified hospitals, regardless of practice or 
location, are given due consideration, and that the unified and 
integrated QAPI program has mechanisms in place to ensure that issues 
localized to particular hospitals are duly considered and addressed.

[68 FR 3454, Jan. 24, 2003, as amended at 84 FR 51818, Sept. 30, 2019]



Sec. 482.22  Condition of participation: Medical staff.

    The hospital must have an organized medical staff that operates 
under bylaws approved by the governing body, and which is responsible 
for the quality of medical care provided to patients by the hospital.
    (a) Standard: Eligibility and process for appointment to medical 
staff. The medical staff must be composed of doctors of medicine or 
osteopathy. In accordance with State law, including scope-of-practice 
laws, the medical staff may also include other categories of physicians 
(as listed at Sec. 482.12(c)(1)) and non-physician practitioners who 
are determined to be eligible for appointment by the governing body.
    (1) The medical staff must periodically conduct appraisals of its 
members.
    (2) The medical staff must examine the credentials of all eligible 
candidates for medical staff membership and make recommendations to the 
governing body on the appointment of these candidates in accordance with 
State law, including scope-of-practice laws, and the medical staff 
bylaws, rules, and regulations. A candidate who has been recommended by 
the medical staff and who has been appointed by the governing body is 
subject to all medical staff bylaws, rules, and regulations, in addition 
to the requirements contained in this section.
    (3) When telemedicine services are furnished to the hospital's 
patients through an agreement with a distant-site hospital, the 
governing body of the hospital whose patients are receiving the 
telemedicine services may choose, in lieu of the requirements in 
paragraphs (a)(1) and (a)(2) of this section,

[[Page 19]]

to have its medical staff rely upon the credentialing and privileging 
decisions made by the distant-site hospital when making recommendations 
on privileges for the individual distant-site physicians and 
practitioners providing such services, if the hospital's governing body 
ensures, through its written agreement with the distant-site hospital, 
that all of the following provisions are met:
    (i) The distant-site hospital providing the telemedicine services is 
a Medicare-participating hospital.
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site hospital providing the telemedicine 
services, which provides a current list of the distant-site physician's 
or practitioner's privileges at the distant-site hospital.
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the hospital whose 
patients are receiving the telemedicine services is located.
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the hospital whose patients are receiving 
the telemedicine services, the hospital has evidence of an internal 
review of the distant-site physician's or practitioner's performance of 
these privileges and sends the distant-site hospital such performance 
information for use in the periodic appraisal of the distant-site 
physician or practitioner. At a minimum, this information must include 
all adverse events that result from the telemedicine services provided 
by the distant-site physician or practitioner to the hospital's patients 
and all complaints the hospital has received about the distant-site 
physician or practitioner.
    (4) When telemedicine services are furnished to the hospital's 
patients through an agreement with a distant-site telemedicine entity, 
the governing body of the hospital whose patients are receiving the 
telemedicine services may choose, in lieu of the requirements in 
paragraphs (a)(1) and (a)(2) of this section, to have its medical staff 
rely upon the credentialing and privileging decisions made by the 
distant-site telemedicine entity when making recommendations on 
privileges for the individual distant-site physicians and practitioners 
providing such services, if the hospital's governing body ensures, 
through its written agreement with the distant-site telemedicine entity, 
that the distant-site telemedicine entity furnishes services that, in 
accordance with Sec. 482.12(e), permit the hospital to comply with all 
applicable conditions of participation for the contracted services. The 
hospital's governing body must also ensure, through its written 
agreement with the distant-site telemedicine entity, that all of the 
following provisions are met:
    (i) The distant-site telemedicine entity's medical staff 
credentialing and privileging process and standards at least meet the 
standards at Sec. 482.12(a)(1) through (a)(7) and Sec. 482.22(a)(1) 
through (a)(2).
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site telemedicine entity providing the 
telemedicine services, which provides the hospital with a current list 
of the distant-site physician's or practitioner's privileges at the 
distant-site telemedicine entity.
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the hospital whose 
patients are receiving such telemedicine services is located.
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the hospital whose patients are receiving 
the telemedicine services, the hospital has evidence of an internal 
review of the distant-site physician's or practitioner's performance of 
these privileges and sends the distant-site telemedicine entity such 
performance information for use in the periodic appraisal of the 
distant-site physician or practitioner. At a minimum, this information 
must include all adverse events that result from the telemedicine 
services provided by the distant-site physician or practitioner to the 
hospital's patients, and all complaints the hospital has received about 
the distant-site physician or practitioner.
    (b) Standard: Medical staff organization and accountability. The 
medical

[[Page 20]]

staff must be well organized and accountable to the governing body for 
the quality of the medical care provided to patients.
    (1) The medical staff must be organized in a manner approved by the 
governing body.
    (2) If the medical staff has an executive committee, a majority of 
the members of the committee must be doctors of medicine or osteopathy.
    (3) The responsibility for organization and conduct of the medical 
staff must be assigned only to one of the following:
    (i) An individual doctor of medicine or osteopathy.
    (ii) A doctor of dental surgery or dental medicine, when permitted 
by State law of the State in which the hospital is located.
    (iii) A doctor of podiatric medicine, when permitted by State law of 
the State in which the hospital is located.
    (4) If a hospital is part of a hospital system consisting of 
multiple separately certified hospitals and the system elects to have a 
unified and integrated medical staff for its member hospitals, after 
determining that such a decision is in accordance with all applicable 
State and local laws, each separately certified hospital must 
demonstrate that:
    (i) The medical staff members of each separately certified hospital 
in the system (that is, all medical staff members who hold specific 
privileges to practice at that hospital) have voted by majority, in 
accordance with medical staff bylaws, either to accept a unified and 
integrated medical staff structure or to opt out of such a structure and 
to maintain a separate and distinct medical staff for their respective 
hospital;
    (ii) The unified and integrated medical staff has bylaws, rules, and 
requirements that describe its processes for self-governance, 
appointment, credentialing, privileging, and oversight, as well as its 
peer review policies and due process rights guarantees, and which 
include a process for the members of the medical staff of each 
separately certified hospital (that is, all medical staff members who 
hold specific privileges to practice at that hospital) to be advised of 
their rights to opt out of the unified and integrated medical staff 
structure after a majority vote by the members to maintain a separate 
and distinct medical staff for their hospital;
    (iii) The unified and integrated medical staff is established in a 
manner that takes into account each member hospital's unique 
circumstances and any significant differences in patient populations and 
services offered in each hospital; and
    (iv) The unified and integrated medical staff establishes and 
implements policies and procedures to ensure that the needs and concerns 
expressed by members of the medical staff, at each of its separately 
certified hospitals, regardless of practice or location, are given due 
consideration, and that the unified and integrated medical staff has 
mechanisms in place to ensure that issues localized to particular 
hospitals are duly considered and addressed.
    (c) Standard: Medical staff bylaws. The medical staff must adopt and 
enforce bylaws to carry out its responsibilities. The bylaws must:
    (1) Be approved by the governing body.
    (2) Include a statement of the duties and privileges of each 
category of medical staff (e.g., active, courtesy, etc.)
    (3) Describe the organization of the medical staff.
    (4) Describe the qualifications to be met by a candidate in order 
for the medical staff to recommend that the candidate be appointed by 
the governing body.
    (5) Include a requirement that--
    (i) A medical history and physical examination be completed and 
documented for each patient no more than 30 days before or 24 hours 
after admission or registration, but prior to surgery or a procedure 
requiring anesthesia services, and except as provided under paragraph 
(c)(5)(iii) of this section. The medical history and physical 
examination must be completed and documented by a physician (as defined 
in section 1861(r) of the Act), an oral and maxillofacial surgeon, or 
other qualified licensed individual in accordance with State law and 
hospital policy.
    (ii) An updated examination of the patient, including any changes in 
the patient's condition, be completed and

[[Page 21]]

documented within 24 hours after admission or registration, but prior to 
surgery or a procedure requiring anesthesia services, when the medical 
history and physical examination are completed within 30 days before 
admission or registration, and except as provided under paragraph 
(c)(5)(iii) of this section. The updated examination of the patient, 
including any changes in the patient's condition, must be completed and 
documented by a physician (as defined in section 1861(r) of the Act), an 
oral and maxillofacial surgeon, or other qualified licensed individual 
in accordance with State law and hospital policy.
    (iii) An assessment of the patient (in lieu of the requirements of 
paragraphs (c)(5)(i) and (ii) of this section) be completed and 
documented after registration, but prior to surgery or a procedure 
requiring anesthesia services, when the patient is receiving specific 
outpatient surgical or procedural services and when the medical staff 
has chosen to develop and maintain a policy that identifies, in 
accordance with the requirements at paragraph (c)(5)(v) of this section, 
specific patients as not requiring a comprehensive medical history and 
physical examination, or any update to it, prior to specific outpatient 
surgical or procedural services. The assessment must be completed and 
documented by a physician (as defined in section 1861(r) of the Act), an 
oral and maxillofacial surgeon, or other qualified licensed individual 
in accordance with State law and hospital policy.
    (iv) The medical staff develop and maintain a policy that identifies 
those patients for whom the assessment requirements of paragraph 
(c)(5)(iii) of this section would apply. The provisions of paragraphs 
(c)(5)(iii), (iv), and (v) of this section do not apply to a medical 
staff that chooses to maintain a policy that adheres to the requirements 
of paragraphs of (c)(5)(i) and (ii) of this section for all patients.
    (v) The medical staff, if it chooses to develop and maintain a 
policy for the identification of specific patients to whom the 
assessment requirements in paragraph (c)(5)(iii) of this section would 
apply, must demonstrate evidence that the policy applies only to those 
patients receiving specific outpatient surgical or procedural services 
as well as evidence that the policy is based on:
    (A) Patient age, diagnoses, the type and number of surgeries and 
procedures scheduled to be performed, comorbidities, and the level of 
anesthesia required for the surgery or procedure.
    (B) Nationally recognized guidelines and standards of practice for 
assessment of specific types of patients prior to specific outpatient 
surgeries and procedures.
    (C) Applicable state and local health and safety laws.
    (6) Include criteria for determining the privileges to be granted to 
individual practitioners and a procedure for applying the criteria to 
individuals requesting privileges. For distant-site physicians and 
practitioners requesting privileges to furnish telemedicine services 
under an agreement with the hospital, the criteria for determining 
privileges and the procedure for applying the criteria are also subject 
to the requirements in Sec. 482.12(a)(8) and (a)(9), and Sec. 
482.22(a)(3) and (a)(4).

[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994; 
71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 76 FR 25563, May 
5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, May 12, 2014; 84 FR 
51818, Sept. 30, 2019]



Sec. 482.23  Condition of participation: Nursing services.

    The hospital must have an organized nursing service that provides 
24-hour nursing services. The nursing services must be furnished or 
supervised by a registered nurse.
    (a) Standard: Organization. The hospital must have a well-organized 
service with a plan of administrative authority and delineation of 
responsibilities for patient care. The director of the nursing service 
must be a licensed registered nurse. He or she is responsible for the 
operation of the service, including determining the types and numbers of 
nursing personnel and staff necessary to provide nursing care for all 
areas of the hospital.
    (b) Standard: Staffing and delivery of care. The nursing service 
must have

[[Page 22]]

adequate numbers of licensed registered nurses, licensed practical 
(vocational) nurses, and other personnel to provide nursing care to all 
patients as needed. There must be supervisory and staff personnel for 
each department or nursing unit to ensure, when needed, the immediate 
availability of a registered nurse for the care of any patient.
    (1) The hospital must provide 24-hour nursing services furnished or 
supervised by a registered nurse, and have a licensed practical nurse or 
registered nurse on duty at all times, except for rural hospitals that 
have in effect a 24-hour nursing waiver granted under Sec. 488.54(c) of 
this chapter.
    (2) The nursing service must have a procedure to ensure that 
hospital nursing personnel for whom licensure is required have valid and 
current licensure.
    (3) A registered nurse must supervise and evaluate the nursing care 
for each patient.
    (4) The hospital must ensure that the nursing staff develops and 
keeps current a nursing care plan for each patient that reflects the 
patient's goals and the nursing care to be provided to meet the 
patient's needs. The nursing care plan may be part of an 
interdisciplinary care plan.
    (5) A registered nurse must assign the nursing care of each patient 
to other nursing personnel in accordance with the patient's needs and 
the specialized qualifications and competence of the nursing staff 
available.
    (6) All licensed nurses who provide services in the hospital must 
adhere to the policies and procedures of the hospital. The director of 
nursing service must provide for the adequate supervision and evaluation 
of the clinical activities of all nursing personnel which occur within 
the responsibility of the nursing service, regardless of the mechanism 
through which those personnel are providing services (that is, hospital 
employee, contract, lease, other agreement, or volunteer).
    (7) The hospital must have policies and procedures in place 
establishing which outpatient departments, if any, are not required 
under hospital policy to have a registered nurse present. The policies 
and procedures must:
    (i) Establish the criteria such outpatient departments must meet, 
taking into account the types of services delivered, the general level 
of acuity of patients served by the department, and the established 
standards of practice for the services delivered;
    (ii) Establish alternative staffing plans;
    (iii) Be approved by the director of nursing;
    (iv) Be reviewed at least once every 3 years.
    (c) Standard: Preparation and administration of drugs. (1) Drugs and 
biologicals must be prepared and administered in accordance with Federal 
and State laws, the orders of the practitioner or practitioners 
responsible for the patient's care, and accepted standards of practice.
    (i) Drugs and biologicals may be prepared and administered on the 
orders of other practitioners not specified under Sec. 482.12(c) only 
if such practitioners are acting in accordance with State law, including 
scope-of-practice laws, hospital policies, and medical staff bylaws, 
rules, and regulations.
    (ii) Drugs and biologicals may be prepared and administered on the 
orders contained within pre-printed and electronic standing orders, 
order sets, and protocols for patient orders only if such orders meet 
the requirements of Sec. 482.24(c)(3).
    (2) All drugs and biologicals must be administered by, or under 
supervision of, nursing or other personnel in accordance with Federal 
and State laws and regulations, including applicable licensing 
requirements, and in accordance with the approved medical staff policies 
and procedures.
    (3) With the exception of influenza and pneumococcal vaccines, which 
may be administered per physician-approved hospital policy after an 
assessment of contraindications, orders for drugs and biologicals must 
be documented and signed by a practitioner who is authorized to write 
orders in accordance with State law and hospital policy, and who is 
responsible for the care of the patient.
    (i) If verbal orders are used, they are to be used infrequently.
    (ii) When verbal orders are used, they must only be accepted by 
persons who

[[Page 23]]

are authorized to do so by hospital policy and procedures consistent 
with Federal and State law.
    (iii) Orders for drugs and biologicals may be documented and signed 
by other practitioners only if such practitioners are acting in 
accordance with State law, including scope-of-practice laws, hospital 
policies, and medical staff bylaws, rules, and regulations.
    (4) Blood transfusions and intravenous medications must be 
administered in accordance with State law and approved medical staff 
policies and procedures.
    (5) There must be a hospital procedure for reporting transfusion 
reactions, adverse drug reactions, and errors in administration of 
drugs.
    (6) The hospital may allow a patient (or his or her caregiver/
support person where appropriate) to self-administer both hospital-
issued medications and the patient's own medications brought into the 
hospital, as defined and specified in the hospital's policies and 
procedures.
    (i) If the hospital allows a patient to self-administer specific 
hospital-issued medications, then the hospital must have policies and 
procedures in place to:
    (A) Ensure that a practitioner responsible for the care of the 
patient has issued an order, consistent with hospital policy, permitting 
self-administration.
    (B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified 
medication(s).
    (C) Instruct the patient (or the patient's caregiver/support person 
where appropriate) in the safe and accurate administration of the 
specified medication(s).
    (D) Address the security of the medication(s) for each patient.
    (E) Document the administration of each medication, as reported by 
the patient (or the patient's caregiver/support person where 
appropriate), in the patient's medical record.
    (ii) If the hospital allows a patient to self-administer his or her 
own specific medications brought into the hospital, then the hospital 
must have policies and procedures in place to:
    (A) Ensure that a practitioner responsible for the care of the 
patient has issued an order, consistent with hospital policy, permitting 
self-administration of medications the patient brought into the 
hospital.
    (B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified 
medication(s), and also determine if the patient (or the patient's 
caregiver/support person where appropriate) needs instruction in the 
safe and accurate administration of the specified medication(s).
    (C) Identify the specified medication(s) and visually evaluate the 
medication(s) for integrity.
    (D) Address the security of the medication(s) for each patient.
    (E) Document the administration of each medication, as reported by 
the patient (or the patient's caregiver/support person where 
appropriate), in the patient's medical record.

[51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002; 71 
FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 
16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR 44129, July 30, 2014; 84 FR 
51819, Sept. 30, 2019]



Sec. 482.24  Condition of participation: Medical record services.

    The hospital must have a medical record service that has 
administrative responsibility for medical records. A medical record must 
be maintained for every individual evaluated or treated in the hospital.
    (a) Standard: Organization and staffing. The organization of the 
medical record service must be appropriate to the scope and complexity 
of the services performed. The hospital must employ adequate personnel 
to ensure prompt completion, filing, and retrieval of records.
    (b) Standard: Form and retention of record. The hospital must 
maintain a medical record for each inpatient and outpatient. Medical 
records must be accurately written, promptly completed, properly filed 
and retained, and accessible. The hospital must use a system of author 
identification and record maintenance that ensures the integrity of the 
authentification and protects the security of all record entries.

[[Page 24]]

    (1) Medical records must be retained in their original or legally 
reproduced form for a period of at least 5 years.
    (2) The hospital must have a system of coding and indexing medical 
records. The system must allow for timely retrieval by diagnosis and 
procedure, in order to support medical care evaluation studies.
    (3) The hospital must have a procedure for ensuring the 
confidentiality of patient records. In-formation from or copies of 
records may be released only to authorized individuals, and the hospital 
must ensure that unauthorized individuals cannot gain access to or alter 
patient records. Original medical records must be released by the 
hospital only in accordance with Federal or State laws, court orders, or 
subpoenas.
    (c) Standard: Content of record. The medical record must contain 
information to justify admission and continued hospitalization, support 
the diagnosis, and describe the patient's progress and response to 
medications and services.
    (1) All patient medical record entries must be legible, complete, 
dated, timed, and authenticated in written or electronic form by the 
person responsible for providing or evaluating the service provided, 
consistent with hospital policies and procedures.
    (2) All orders, including verbal orders, must be dated, timed, and 
authenticated promptly by the ordering practitioner or by another 
practitioner who is responsible for the care of the patient only if such 
a practitioner is acting in accordance with State law, including scope-
of-practice laws, hospital policies, and medical staff bylaws, rules, 
and regulations.
    (3) Hospitals may use pre-printed and electronic standing orders, 
order sets, and protocols for patient orders only if the hospital:
    (i) Establishes that such orders and protocols have been reviewed 
and approved by the medical staff and the hospital's nursing and 
pharmacy leadership;
    (ii) Demonstrates that such orders and protocols are consistent with 
nationally recognized and evidence-based guidelines;
    (iii) Ensures that the periodic and regular review of such orders 
and protocols is conducted by the medical staff and the hospital's 
nursing and pharmacy leadership to determine the continuing usefulness 
and safety of the orders and protocols; and
    (iv) Ensures that such orders and protocols are dated, timed, and 
authenticated promptly in the patient's medical record by the ordering 
practitioner or by another practitioner responsible for the care of the 
patient only if such a practitioner is acting in accordance with State 
law, including scope-of-practice laws, hospital policies, and medical 
staff bylaws, rules, and regulations.
    (4) All records must document the following, as appropriate:
    (i) Evidence of--
    (A) A medical history and physical examination completed and 
documented no more than 30 days before or 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services, and except as provided under paragraph (c)(4)(i)(C) of this 
section. The medical history and physical examination must be placed in 
the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (B) An updated examination of the patient, including any changes in 
the patient's condition, when the medical history and physical 
examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (c)(4)(i)(C) of 
this section. Documentation of the updated examination must be placed in 
the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (C) An assessment of the patient (in lieu of the requirements of 
paragraphs (c)(4)(i)(A) and (B) of this section) completed and 
documented after registration, but prior to surgery or a procedure 
requiring anesthesia services, when the patient is receiving specific 
outpatient surgical or procedural services and when the medical staff 
has chosen to develop and maintain a policy that identifies, in 
accordance with the requirements at Sec. 482.22(c)(5)(v), specific 
patients as not requiring a

[[Page 25]]

comprehensive medical history and physical examination, or any update to 
it, prior to specific outpatient surgical or procedural services.
    (ii) Admitting diagnosis.
    (iii) Results of all consultative evaluations of the patient and 
appropriate findings by clinical and other staff involved in the care of 
the patient.
    (iv) Documentation of complications, hospital acquired infections, 
and unfavorable reactions to drugs and anesthesia.
    (v) Properly executed informed consent forms for procedures and 
treatments specified by the medical staff, or by Federal or State law if 
applicable, to require written patient consent.
    (vi) All practitioners' orders, nursing notes, reports of treatment, 
medication records, radiology, and laboratory reports, and vital signs 
and other information necessary to monitor the patient's condition.
    (vii) Discharge summary with outcome of hospitalization, disposition 
of case, and provisions for follow-up care.
    (viii) Final diagnosis with completion of medical records within 30 
days following discharge.
    (d) Standard: Electronic notifications. If the hospital utilizes an 
electronic medical records system or other electronic administrative 
system, which is conformant with the content exchange standard at 45 CFR 
170.205(d)(2), then the hospital must demonstrate that--
    (1) The system's notification capacity is fully operational and the 
hospital uses it in accordance with all State and Federal statutes and 
regulations applicable to the hospital's exchange of patient health 
information.
    (2) The system sends notifications that must include at least 
patient name, treating practitioner name, and sending institution name.
    (3) To the extent permissible under applicable federal and state law 
and regulations, and not inconsistent with the patient's expressed 
privacy preferences, the system sends notifications directly, or through 
an intermediary that facilitates exchange of health information, at the 
time of:
    (i) The patient's registration in the hospital's emergency 
department (if applicable).
    (ii) The patient's admission to the hospital's inpatient services 
(if applicable).
    (4) To the extent permissible under applicable federal and state law 
and regulations and not inconsistent with the patient's expressed 
privacy preferences, the system sends notifications directly, or through 
an intermediary that facilitates exchange of health information, either 
immediately prior to, or at the time of:
    (i) The patient's discharge or transfer from the hospital's 
emergency department (if applicable).
    (ii) The patient's discharge or transfer from the hospital's 
inpatient services (if applicable).
    (5) The hospital has made a reasonable effort to ensure that the 
system sends the notifications to all applicable post-acute care 
services providers and suppliers, as well as to any of the following 
practitioners and entities, which need to receive notification of the 
patient's status for treatment, care coordination, or quality 
improvement purposes:
    (i) The patient's established primary care practitioner;
    (ii) The patient's established primary care practice group or 
entity; or
    (iii) Other practitioner, or other practice group or entity, 
identified by the patient as the practitioner, or practice group or 
entity, primarily responsible for his or her care.

[51 FR 22042, June 17, 1986, as amended at 71 FR 68694, Nov. 27, 2006; 
72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 16, 2012; 84 FR 51819, 
Sept. 30, 2019; 85 FR 25637, May 1, 2020]



Sec. 482.25  Condition of participation: Pharmaceutical services.

    The hospital must have pharmaceutical services that meet the needs 
of the patients. The institution must have a pharmacy directed by a 
registered pharmacist or a drug storage area under competent 
supervision. The medical staff is responsible for developing policies 
and procedures that minimize drug errors. This function may be delegated 
to the hospital's organized pharmaceutical service.
    (a) Standard: Pharmacy management and administration. The pharmacy 
or

[[Page 26]]

drug storage area must be administered in accordance with accepted 
professional principles.
    (1) A full-time, part-time, or consulting pharmacist must be 
responsible for developing, supervising, and coordinating all the 
activities of the pharmacy services.
    (2) The pharmaceutical service must have an adequate number of 
personnel to ensure quality pharmaceutical services, including emergency 
services.
    (3) Current and accurate records must be kept of the receipt and 
disposition of all scheduled drugs.
    (b) Standard: Delivery of services. In order to provide patient 
safety, drugs and biologicals must be controlled and distributed in 
accordance with applicable standards of practice, consistent with 
Federal and State law.
    (1) All compounding, packaging, and dispensing of drugs and 
biologicals must be under the supervision of a pharmacist and performed 
consistent with State and Federal laws.
    (2)(i) All drugs and biologicals must be kept in a secure area, and 
locked when appropriate.
    (ii) Drugs listed in Schedules II, III, IV, and V of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept 
locked within a secure area.
    (iii) Only authorized personnel may have access to locked areas.
    (3) Outdated, mislabeled, or otherwise unusable drugs and 
biologicals must not be available for patient use.
    (4) When a pharmacist is not available, drugs and biologicals must 
be removed from the pharmacy or storage area only by personnel 
designated in the policies of the medical staff and pharmaceutical 
service, in accordance with Federal and State law.
    (5) Drugs and biologicals not specifically prescribed as to time or 
number of doses must automatically be stopped after a reasonable time 
that is predetermined by the medical staff.
    (6) Drug administration errors, adverse drug reactions, and 
incompatibilities must be immediately reported to the attending 
physician and, if appropriate, to the hospital's quality assessment and 
performance improvement program.
    (7) Abuses and losses of controlled substances must be reported, in 
accordance with applicable Federal and State laws, to the individual 
responsible for the pharmaceutical service, and to the chief executive 
officer, as appropriate.
    (8) Information relating to drug interactions and information of 
drug therapy, side effects, toxicology, dosage, indications for use, and 
routes of administration must be available to the professional staff.
    (9) A formulary system must be established by the medical staff to 
assure quality pharmaceuticals at reasonable costs.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, 
Nov. 27, 2006; 77 FR 29075, May 16, 2012]



Sec. 482.26  Condition of participation: Radiologic services.

    The hospital must maintain, or have available, diagnostic radiologic 
services. If therapeutic services are also provided, they, as well as 
the diagnostic services, must meet professionally approved standards for 
safety and personnel qualifications.
    (a) Standard: Radiologic services. The hospital must maintain, or 
have available, radiologic services according to needs of the patients.
    (b) Standard: Safety for patients and personnel. The radiologic 
services, particularly ionizing radiology procedures, must be free from 
hazards for patients and personnel.
    (1) Proper safety precutions must be maintained against radiation 
hazards. This includes adequate shielding for patients, personnel, and 
facilities, as well as appropriate storage, use, and disposal of 
radioactive materials.
    (2) Periodic inspection of equipment must be made and hazards 
identified must be promptly corrected.
    (3) Radiation workers must be checked periodically, by the use of 
exposure meters or badge tests, for amount of radiation exposure.
    (4) Radiologic services must be provided only on the order of 
practitioners with clinical privileges or, consistent with State law, of 
other practitioners authorized by the medical staff and the governing 
body to order the services.

[[Page 27]]

    (c) Standard: Personnel. (1) A qualified full-time, part-time, or 
consulting radiologist must supervise the ionizing radiology services 
and must interpret only those radiologic tests that are determined by 
the medical staff to require a radiologist's specialized knowledge. For 
purposes of this section, a radiologist is a doctor of medicine or 
osteopathy who is qualified by education and experience in radiology.
    (2) Only personnel designated as qualified by the medical staff may 
use the radiologic equipment and administer procedures.
    (d) Standard: Records. Records of radiologic services must be 
maintained.
    (1) The radiologist or other practitioner who performs radiology 
services must sign reports of his or her interpretations.
    (2) The hospital must maintain the following for at least 5 years:
    (i) Copies of reports and printouts.
    (ii) Films, scans, and other image records, as appropriate.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]



Sec. 482.27  Condition of participation: Laboratory services.

    The hospital must maintain, or have available, adequate laboratory 
services to meet the needs of its patients. The hospital must ensure 
that all laboratory services provided to its patients are performed in a 
facility certified in accordance with part 493 of this chapter.
    (a) Standard: Adequacy of laboratory services. The hospital must 
have laboratory services available, either directly or through a 
contractual agreement with a certified laboratory that meets 
requirements of part 493 of this chapter.
    (1) Emergency laboratory services must be available 24 hours a day.
    (2) A written description of services provided must be available to 
the medical staff.
    (3) The laboratory must make provision for proper receipt and 
reporting of tissue specimens.
    (4) The medical staff and a pathologist must determine which tissue 
specimens require a macroscopic (gross) examination and which require 
both macroscopic and microscopic examinations.
    (b) Standard: Potentially infectious blood and blood components--(1) 
Potentially human immunodeficiency virus (HIV) infectious blood and 
blood components. Potentially HIV infectious blood and blood components 
are prior collections from a donor--
    (i) Who tested negative at the time of donation but tests reactive 
for evidence of HIV infection on a later donation;
    (ii) Who tests positive on the supplemental (additional, more 
specific) test or other follow-up testing required by FDA; and
    (iii) For whom the timing of seroconversion cannot be precisely 
estimated.
    (2) Potentially hepatitis C virus (HCV) infectious blood and blood 
components. Potentially HCV infectious blood and blood components are 
the blood and blood components identified in 21 CFR 610.47.
    (3) Services furnished by an outside blood collecting establishment. 
If a hospital regularly uses the services of an outside blood collecting 
establishment, it must have an agreement with the blood collecting 
establishment that governs the procurement, transfer, and availability 
of blood and blood components. The agreement must require that the blood 
collecting establishment notify the hospital--
    (i) Within 3 calendar days if the blood collecting establishment 
supplied blood and blood components collected from a donor who tested 
negative at the time of donation but tests reactive for evidence of HIV 
or HCV infection on a later donation or who is determined to be at 
increased risk for transmitting HIV or HCV infection;
    (ii) Within 45 days of the test, of the results of the supplemental 
(additional, more specific) test for HIV or HCV, as relevant, or other 
follow-up testing required by FDA; and
    (iii) Within 3 calendar days after the blood collecting 
establishment supplied blood and blood components collected from an 
infectious donor, whenever records are available.
    (4) Quarantine and disposition of blood and blood components pending 
completion

[[Page 28]]

of testing. If the blood collecting establishment (either internal or 
under an agreement) notifies the hospital of the reactive HIV or HCV 
screening test results, the hospital must determine the disposition of 
the blood or blood product and quarantine all blood and blood components 
from previous donations in inventory.
    (i) If the blood collecting establishment notifies the hospital that 
the result of the supplemental (additional, more specific) test or other 
follow-up testing required by FDA is negative, absent other informative 
test results, the hospital may release the blood and blood components 
from quarantine.
    (ii) If the blood collecting establishment notifies the hospital 
that the result of the supplemental, (additional, more specific) test or 
other follow-up testing required by FDA is positive, the hospital must--
    (A) Dispose of the blood and blood components; and
    (B) Notify the transfusion beneficiaries as set forth in paragraph 
(b)(6) of this section.
    (iii) If the blood collecting establishment notifies the hospital 
that the result of the supplemental, (additional, more specific) test or 
other follow-up testing required by FDA is indeterminate, the hospital 
must destroy or label prior collections of blood or blood components 
held in quarantine as set forth at 21 CFR 610.46(b)(2) and 610.47(b)(2).
    (5) Recordkeeping by the hospital. The hospital must maintain--
    (i) Records of the source and disposition of all units of blood and 
blood components for at least 10 years from the date of disposition in a 
manner that permits prompt retrieval; and
    (ii) A fully funded plan to transfer these records to another 
hospital or other entity if such hospital ceases operation for any 
reason.
    (6) Patient notification. If the hospital has administered 
potentially HIV or HCV infectious blood or blood components (either 
directly through its own blood collecting establishment or under an 
agreement) or released such blood or blood components to another entity 
or individual, the hospital must take the following actions:
    (i) Make reasonable attempts to notify the patient, or to notify the 
attending physician or the physician who ordered the blood or blood 
component and ask the physician to notify the patient, or other 
individual as permitted under paragraph (b)(10) of this section, that 
potentially HIV or HCV infectious blood or blood components were 
transfused to the patient and that there may be a need for HIV or HCV 
testing and counseling.
    (ii) If the physician is unavailable or declines to make the 
notification, make reasonable attempts to give this notification to the 
patient, legal guardian, or relative.
    (iii) Document in the patient's medical record the notification or 
attempts to give the required notification.
    (7) Timeframe for notification--For donors tested on or after 
February 20, 2008. For notifications resulting from donors tested on or 
after February 20, 2008 as set forth at 21 CFR 610.46 and 610.47 the 
notification effort begins when the blood collecting establishment 
notifies the hospital that it received potentially HIV or HCV infectious 
blood and blood components. The hospital must make reasonable attempts 
to give notification over a period of 12 weeks unless--
    (i) The patient is located and notified; or
    (ii) The hospital is unable to locate the patient and documents in 
the patient's medical record the extenuating circumstances beyond the 
hospital's control that caused the notification timeframe to exceed 12 
weeks.
    (8) Content of notification. The notification must include the 
following information:
    (i) A basic explanation of the need for HIV or HCV testing and 
counseling;
    (ii) Enough oral or written information so that an informed decision 
can be made about whether to obtain HIV or HCV testing and counseling; 
and
    (iii) A list of programs or places where the person can obtain HIV 
or HCV testing and counseling, including any requirements or 
restrictions the program may impose.
    (9) Policies and procedures. The hospital must establish policies 
and procedures for notification and documentation that conform to 
Federal, State,

[[Page 29]]

and local laws, including requirements for the confidentiality of 
medical records and other patient information.
    (10) Notification to legal representative or relative. If the 
patient has been adjudged incompetent by a State court, the physician or 
hospital must notify a legal representative designated in accordance 
with State law. If the patient is competent, but State law permits a 
legal representative or relative to receive the information on the 
patient's behalf, the physician or hospital must notify the patient or 
his or her legal representative or relative. For possible HIV infectious 
transfusion beneficiaries that are deceased, the physician or hospital 
must inform the deceased patient's legal representative or relative. If 
the patient is a minor, the parents or legal guardian must be notified.
    (c) General blood safety issues. For lookback activities only 
related to new blood safety issues that are identified after August 24, 
2007, hospitals must comply with FDA regulations as they pertain to 
blood safety issues in the following areas:
    (1) Appropriate testing and quarantining of infectious blood and 
blood components.
    (2) Notification and counseling of beneficiaries that may have 
received infectious blood and blood components.

[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72 
FR 48573, Aug. 24, 2007; 84 FR 51819, Sept. 30, 2019; 85 FR 72909, Nov. 
16, 2020]



Sec. 482.28  Condition of participation: Food and dietetic services.

    The hospital must have organized dietary services that are directed 
and staffed by adequate qualified personnel. However, a hospital that 
has a contract with an outside food management company may be found to 
meet this Condition of participation if the company has a dietitian who 
serves the hospital on a full-time, part-time, or consultant basis, and 
if the company maintains at least the minimum standards specified in 
this section and provides for constant liaison with the hospital medical 
staff for recommendations on dietetic policies affecting patient 
treatment.
    (a) Standard: Organization. (1) The hospital must have a full-time 
employee who--
    (i) Serves as director of the food and dietetic service;
    (ii) Is responsible for the daily management of the dietary 
services; and
    (iii) Is qualified by experience or training.
    (2) There must be a qualified dietitian, full-time, part-time, or on 
a consultant basis.
    (3) There must be administrative and technical personnel competent 
in their respective duties.
    (b) Standard: Diets. Menus must meet the needs of the patients.
    (1) Individual patient nutritional needs must be met in accordance 
with recognized dietary practices.
    (2) All patient diets, including therapeutic diets, must be ordered 
by a practitioner responsible for the care of the patient, or by a 
qualified dietitian or qualified nutrition professional as authorized by 
the medical staff and in accordance with State law governing dietitians 
and nutrition professionals.
    (3) A current therapeutic diet manual approved by the dietitian and 
medical staff must be readily available to all medical, nursing, and 
food service personnel.

[51 FR 22042, June 17, 1986, as amended at 79 FR 27154, May 12, 2014]



Sec. 482.30  Condition of participation: Utilization review.

    The hospital must have in effect a utilization review (UR) plan that 
provides for review of services furnished by the institution and by 
members of the medical staff to patients entitled to benefits under the 
Medicare and Medicaid programs.
    (a) Applicability. The provisions of this section apply except in 
either of the following circumstances:
    (1) A Utilization and Quality Control Quality Improvement 
Organization (QIO) has assumed binding review for the hospital.
    (2) CMS has determined that the UR procedures established by the 
State under title XIX of the Act are superior to the procedures required 
in this section, and has required hospitals in that

[[Page 30]]

State to meet the UR plan requirements under Sec. Sec. 456.50 through 
456.245 of this chapter.
    (b) Standard: Composition of utilization review committee. A UR 
committee consisting of two or more practitioners must carry out the UR 
function. At least two of the members of the committee must be doctors 
of medicine or osteopathy. The other members may be any of the other 
types of practitioners specified in Sec. 482.12(c)(1).
    (1) Except as specified in paragraphs (b) (2) and (3) of this 
section, the UR committee must be one of the following:
    (i) A staff committee of the institution;
    (ii) A group outside the institution--
    (A) Established by the local medical society and some or all of the 
hospitals in the locality; or
    (B) Established in a manner approved by CMS.
    (2) If, because of the small size of the institution, it is 
impracticable to have a properly functioning staff committee, the UR 
committee must be established as specified in paragraph (b)(1)(ii) of 
this section.
    (3) The committee's or group's reviews may not be conducted by any 
individual who--
    (i) Has a direct financial interest (for example, an ownership 
interest) in that hospital; or
    (ii) Was professionally involved in the care of the patient whose 
case is being reviewed.
    (c) Standard: Scope and frequency of review. (1) The UR plan must 
provide for review for Medicare and Medicaid patients with respect to 
the medical necessity of--
    (i) Admissions to the institution;
    (ii) The duration of stays; and
    (iii) Professional services furnished, including drugs and 
biologicals.
    (2) Review of admissions may be performed before, at, or after 
hospital admission.
    (3) Except as specified in paragraph (e) of this section, reviews 
may be conducted on a sample basis.
    (4) Hospitals that are paid for inpatient hospital services under 
the prospective payment system set forth in part 412 of this chapter 
must conduct review of duration of stays and review of professional 
services as follows:
    (i) For duration of stays, these hospitals need review only cases 
that they reasonably assume to be outlier cases based on extended length 
of stay, as described in Sec. 412.80(a)(1)(i) of this chapter; and
    (ii) For professional services, these hospitals need review only 
cases that they reasonably assume to be outlier cases based on 
extraordinarily high costs, as described in Sec. 412.80(a)(1)(ii) of 
this chapter.
    (d) Standard: Determination regarding admissions or continued stays. 
(1) The determination that an admission or continued stay is not 
medically necessary--
    (i) May be made by one member of the UR committee if the 
practitioner or practitioners responsible for the care of the patient, 
as specified of Sec. 482.12(c), concur with the determination or fail 
to present their views when afforded the opportunity; and
    (ii) Must be made by at least two members of the UR committee in all 
other cases.
    (2) Before making a determination that an admission or continued 
stay is not medically necessary, the UR committee must consult the 
practitioner or practitioners responsible for the care of the patient, 
as specified in Sec. 482.12(c), and afford the practitioner or 
practitioners the opportunity to present their views.
    (3) If the committee decides that admission to or continued stay in 
the hospital is not medically necessary, written notification must be 
given, no later than 2 days after the determination, to the hospital, 
the patient, and the practitioner or practitioners responsible for the 
care of the patient, as specified in Sec. 482.12(c);
    (e) Standard: Extended stay review. (1) In hospitals that are not 
paid under the prospective payment system, the UR committee must make a 
periodic review, as specified in the UR plan, of each current inpatient 
receiving hospital services during a continuous period of extended 
duration. The scheduling of the periodic reviews may--
    (i) Be the same for all cases; or
    (ii) Differ for different classes of cases.

[[Page 31]]

    (2) In hospitals paid under the prospective payment system, the UR 
committee must review all cases reasonably assumed by the hospital to be 
outlier cases because the extended length of stay exceeds the threshold 
criteria for the diagnosis, as described in Sec. 412.80(a)(1)(i). The 
hospital is not required to review an extended stay that does not exceed 
the outlier threshold for the diagnosis.
    (3) The UR committee must make the periodic review no later than 7 
days after the day required in the UR plan.
    (f) Standard: Review of professional services. The committee must 
review professional services provided, to determine medical necessity 
and to promote the most efficient use of available health facilities and 
services.



Sec. 482.41  Condition of participation: Physical environment.

    The hospital must be constructed, arranged, and maintained to ensure 
the safety of the patient, and to provide facilities for diagnosis and 
treatment and for special hospital services appropriate to the needs of 
the community.
    (a) Standard: Buildings. The condition of the physical plant and the 
overall hospital environment must be developed and maintained in such a 
manner that the safety and well-being of patients are assured.
    (1) There must be emergency power and lighting in at least the 
operating, recovery, intensive care, and emergency rooms, and 
stairwells. In all other areas not serviced by the emergency supply 
source, battery lamps and flashlights must be available.
    (2) There must be facilities for emergency gas and water supply.
    (b) Standard: Life safety from fire. (1) Except as otherwise 
provided in this section--
    (i) The hospital 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.) 
Outpatient surgical departments must meet the provisions applicable to 
Ambulatory Health Care Occupancies, regardless of the number of patients 
served.
    (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) 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 
hospital, but only if the waiver will not adversely affect the health 
and safety of the patients.
    (3) The provisions of the Life Safety Code do not apply in a State 
where CMS finds that a fire and safety code imposed by State law 
adequately protects patients in hospitals.
    (4) The hospital must have procedures for the proper routine storage 
and prompt disposal of trash.
    (5) The hospital must have written fire control plans that contain 
provisions for prompt reporting of fires; extinguishing fires; 
protection of patients, personnel and guests; evacuation; and 
cooperation with fire fighting authorities.
    (6) The hospital must maintain written evidence of regular 
inspection and approval by State or local fire control agencies.
    (7) A hospital may install alcohol-based hand rub dispensers in its 
facility if the dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (8) When a sprinkler system is shut down for more than 10 hours, the 
hospital must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (9) Buildings must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (i) The sill height requirement does not apply to newborn nurseries 
and

[[Page 32]]

rooms intended for occupancy for less than 24 hours.
    (ii) The sill height in special nursing care areas of new 
occupancies must not exceed 60 inches.
    (c) Standard: Building safety. Except as otherwise provided in this 
section, the hospital 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 hospital.
    (2) If application of the Health Care Facilities Code required under 
paragraph (c) of this section would result in unreasonable hardship for 
the hospital, 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.
    (d) Standard: Facilities. The hospital must maintain adequate 
facilities for its services.
    (1) Diagnostic and therapeutic facilities must be located for the 
safety of patients.
    (2) Facilities, supplies, and equipment must be maintained to ensure 
an acceptable level of safety and quality.
    (3) The extent and complexity of facilities must be determined by 
the services offered.
    (4) There must be proper ventilation, light, and temperature 
controls in pharmaceutical, food preparation, and other appropriate 
areas.
    (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]

[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68 
FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar. 
25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26899, May 4, 2016; 81 FR 
42548, June 30, 2016]



Sec. 482.42  Condition of participation: Infection prevention 
and control and antibiotic stewardship programs.

    The hospital must have active hospital-wide programs for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases, and for the optimization of antibiotic use through 
stewardship. The programs must demonstrate adherence to nationally 
recognized infection prevention and control guidelines, as well as to 
best practices for improving antibiotic use where applicable, and for 
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and 
antibiotic use issues identified in the programs must be addressed in 
collaboration with the hospital-wide quality assessment and performance 
improvement (QAPI) program.

[[Page 33]]

    (a) Standard: Infection prevention and control program organization 
and policies. The hospital must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, experience, or certification in infection 
prevention and control, is appointed by the governing body as the 
infection preventionist(s)/infection control professional(s) responsible 
for the infection prevention and control program and that the 
appointment is based on the recommendations of medical staff leadership 
and nursing leadership;
    (2) The hospital infection prevention and control program, as 
documented in its policies and procedures, employs methods for 
preventing and controlling the transmission of infections within the 
hospital and between the hospital and other institutions and settings;
    (3) The infection prevention and control program includes 
surveillance, prevention, and control of HAIs, including maintaining a 
clean and sanitary environment to avoid sources and transmission of 
infection, and addresses any infection control issues identified by 
public health authorities; and
    (4) The infection prevention and control program reflects the scope 
and complexity of the hospital services provided.
    (b) Standard: Antibiotic stewardship program organization and 
policies. The hospital must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, or experience in infectious diseases and/or 
antibiotic stewardship, is appointed by the governing body as the 
leader(s) of the antibiotic stewardship program and that the appointment 
is based on the recommendations of medical staff leadership and pharmacy 
leadership;
    (2) The hospital-wide antibiotic stewardship program:
    (i) Demonstrates coordination among all components of the hospital 
responsible for antibiotic use and resistance, including, but not 
limited to, the infection prevention and control program, the QAPI 
program, the medical staff, nursing services, and pharmacy services;
    (ii) Documents the evidence-based use of antibiotics in all 
departments and services of the hospital; and
    (iii) Documents any improvements, including sustained improvements, 
in proper antibiotic use;
    (3) The antibiotic stewardship program adheres to nationally 
recognized guidelines, as well as best practices, for improving 
antibiotic use; and
    (4) The antibiotic stewardship program reflects the scope and 
complexity of the hospital services provided.
    (c) Standard: Leadership responsibilities. (1) The governing body 
must ensure all of the following:
    (i) Systems are in place and operational for the tracking of all 
infection surveillance, prevention, and control, and antibiotic use 
activities, in order to demonstrate the implementation, success, and 
sustainability of such activities.
    (ii) All HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed in 
collaboration with hospital QAPI leadership.
    (2) The infection preventionist(s)/infection control professional(s) 
is responsible for:
    (i) The development and implementation of hospital-wide infection 
surveillance, prevention, and control policies and procedures that 
adhere to nationally recognized guidelines.
    (ii) All documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities.
    (iii) Communication and collaboration with the hospital's QAPI 
program on infection prevention and control issues.
    (iv) Competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of infection prevention and control guidelines, policies, 
and procedures.
    (v) The prevention and control of HAIs, including auditing of 
adherence to infection prevention and control

[[Page 34]]

policies and procedures by hospital personnel.
    (vi) Communication and collaboration with the antibiotic stewardship 
program.
    (3) The leader(s) of the antibiotic stewardship program is 
responsible for:
    (i) The development and implementation of a hospital-wide antibiotic 
stewardship program, based on nationally recognized guidelines, to 
monitor and improve the use of antibiotics.
    (ii) All documentation, written or electronic, of antibiotic 
stewardship program activities.
    (iii) Communication and collaboration with medical staff, nursing, 
and pharmacy leadership, as well as with the hospital's infection 
prevention and control and QAPI programs, on antibiotic use issues.
    (iv) Competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of antibiotic stewardship guidelines, policies, and 
procedures.
    (d) Standard: Unified and integrated infection prevention and 
control and antibiotic stewardship programs for multi-hospital systems. 
If a hospital is part of a hospital system consisting of multiple 
separately certified hospitals using a system governing body that is 
legally responsible for the conduct of two or more hospitals, the system 
governing body can elect to have unified and integrated infection 
prevention and control and antibiotic stewardship programs for all of 
its member hospitals after determining that such a decision is in 
accordance with all applicable State and local laws. The system 
governing body is responsible and accountable for ensuring that each of 
its separately certified hospitals meets all of the requirements of this 
section. Each separately certified hospital subject to the system 
governing body must demonstrate that:
    (1) The unified and integrated infection prevention and control and 
antibiotic stewardship programs are established in a manner that takes 
into account each member hospital's unique circumstances and any 
significant differences in patient populations and services offered in 
each hospital;
    (2) The unified and integrated infection prevention and control and 
antibiotic stewardship programs establish and implement policies and 
procedures to ensure that the needs and concerns of each of its 
separately certified hospitals, regardless of practice or location, are 
given due consideration;
    (3) The unified and integrated infection prevention and control and 
antibiotic stewardship programs have mechanisms in place to ensure that 
issues localized to particular hospitals are duly considered and 
addressed; and
    (4) A qualified individual (or individuals) with expertise in 
infection prevention and control and in antibiotic stewardship has been 
designated at the hospital as responsible for communicating with the 
unified infection prevention and control and antibiotic stewardship 
programs, for implementing and maintaining the policies and procedures 
governing infection prevention and control and antibiotic stewardship as 
directed by the unified infection prevention and control and antibiotic 
stewardship programs, and for providing education and training on the 
practical applications of infection prevention and control and 
antibiotic stewardship to hospital staff.
    (e) COVID-19 reporting. During the Public Health Emergency, as 
defined in Sec. [thinsp]400.200 of this chapter, the hospital must 
report information in accordance with a frequency as specified by the 
Secretary on COVID-19 in a standardized format specified by the 
Secretary. This report must include, but not be limited to, the 
following data elements:
    (1) The hospital's current inventory supplies of any COVID-19-
related therapeutics that have been distributed and delivered to the 
hospital under the authority and direction of the Secretary; and
    (2) The hospital's current usage rate for any COVID-19-related 
therapeutics that have been distributed and delivered to the hospital 
under the authority and direction of the Secretary.
    (f) Standard: Reporting of Acute Respiratory Illness, including 
Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute 
Respiratory Infection. During

[[Page 35]]

the Public Health Emergency, as defined in Sec. 400.200 of this 
chapter, the hospital must report information, in accordance with a 
frequency as specified by the Secretary, on Acute Respiratory Illness 
(including, but not limited to, Seasonal Influenza Virus, Influenza-like 
Illness, and Severe Acute Respiratory Infection) in a standardized 
format specified by the Secretary.

[84 FR 51820, Sept. 30, 2019, as amended at 85 FR 54872, Sept. 2, 2020; 
85 FR 86303, Dec. 29, 2020]

    Editorial Note: At 85 FR 86303, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.



Sec. 482.43  Condition of participation: Discharge planning.

    The hospital must have an effective discharge planning process that 
focuses on the patient's goals and treatment preferences and includes 
the patient and his or her caregivers/support person(s) as active 
partners in the discharge planning for post-discharge care. The 
discharge planning process and the discharge plan must be consistent 
with the patient's goals for care and his or her treatment preferences, 
ensure an effective transition of the patient from hospital to post-
discharge care, and reduce the factors leading to preventable hospital 
readmissions.
    (a) Standard: Discharge planning process. The hospital's discharge 
planning process must identify, at an early stage of hospitalization, 
those patients who are likely to suffer adverse health consequences upon 
discharge in the absence of adequate discharge planning and must provide 
a discharge planning evaluation for those patients so identified as well 
as for other patients upon the request of the patient, patient's 
representative, or patient's physician.
    (1) Any discharge planning evaluation must be made on a timely basis 
to ensure that appropriate arrangements for post-hospital care will be 
made before discharge and to avoid unnecessary delays in discharge.
    (2) A discharge planning evaluation must include an evaluation of a 
patient's likely need for appropriate post-hospital services, including, 
but not limited to, hospice care services, post-hospital extended care 
services, home health services, and non-health care services and 
community based care providers, and must also include a determination of 
the availability of the appropriate services as well as of the patient's 
access to those services.
    (3) The discharge planning evaluation must be included in the 
patient's medical record for use in establishing an appropriate 
discharge plan and the results of the evaluation must be discussed with 
the patient (or the patient's representative).
    (4) Upon the request of a patient's physician, the hospital must 
arrange for the development and initial implementation of a discharge 
plan for the patient.
    (5) Any discharge planning evaluation or discharge plan required 
under this paragraph must be developed by, or under the supervision of, 
a registered nurse, social worker, or other appropriately qualified 
personnel.
    (6) The hospital's discharge planning process must require regular 
re-evaluation of the patient's condition to identify changes that 
require modification of the discharge plan. The discharge plan must be 
updated, as needed, to reflect these changes.
    (7) The hospital must assess its discharge planning process on a 
regular basis. The assessment must include ongoing, periodic review of a 
representative sample of discharge plans, including those patients who 
were readmitted within 30 days of a previous admission, to ensure that 
the plans are responsive to patient post-discharge needs.
    (8) The hospital must assist patients, their families, or the 
patient's representative in selecting a post-acute care provider by 
using and sharing data that includes, but is not limited to, HHA, SNF, 
IRF, or LTCH data on quality measures and data on resource use measures. 
The hospital must ensure that the post-acute care data on quality 
measures and data on resource use measures is relevant and applicable to 
the patient's goals of care and treatment preferences.
    (b) Standard: Discharge of the patient and provision and 
transmission of the patient's necessary medical information.

[[Page 36]]

The hospital must discharge the patient, and also transfer or refer the 
patient where applicable, along with all necessary medical information 
pertaining to the patient's current course of illness and treatment, 
post-discharge goals of care, and treatment preferences, at the time of 
discharge, to the appropriate post-acute care service providers and 
suppliers, facilities, agencies, and other outpatient service providers 
and practitioners responsible for the patient's follow-up or ancillary 
care.
    (c) Standard: Requirements related to post-acute care services. For 
those patients discharged home and referred for HHA services, or for 
those patients transferred to a SNF for post-hospital extended care 
services, or transferred to an IRF or LTCH for specialized hospital 
services, the following requirements apply, in addition to those set out 
at paragraphs (a) and (b) of this section:
    (1) The hospital must include in the discharge plan a list of HHAs, 
SNFs, IRFs, or LTCHs that are available to the patient, that are 
participating in the Medicare program, and that serve the geographic 
area (as defined by the HHA) in which the patient resides, or in the 
case of a SNF, IRF, or LTCH, in the geographic area requested by the 
patient. HHAs must request to be listed by the hospital as available.
    (i) This list must only be presented to patients for whom home 
health care post-hospital extended care services, SNF, IRF, or LTCH 
services are indicated and appropriate as determined by the discharge 
planning evaluation.
    (ii) For patients enrolled in managed care organizations, the 
hospital must make the patient aware of the need to verify with their 
managed care organization which practitioners, providers or certified 
suppliers are in the managed care organization's network. If the 
hospital has information on which practitioners, providers or certified 
supplies are in the network of the patient's managed care organization, 
it must share this with the patient or the patient's representative.
    (iii) The hospital must document in the patient's medical record 
that the list was presented to the patient or to the patient's 
representative.
    (2) The hospital, as part of the discharge planning process, must 
inform the patient or the patient's representative of their freedom to 
choose among participating Medicare providers and suppliers of post-
discharge services and must, when possible, respect the patient's or the 
patient's representative's goals of care and treatment preferences, as 
well as other preferences they express. The hospital must not specify or 
otherwise limit the qualified providers or suppliers that are available 
to the patient.
    (3) The discharge plan must identify any HHA or SNF to which the 
patient is referred in which the hospital has a disclosable financial 
interest, as specified by the Secretary, and any HHA or SNF that has a 
disclosable financial interest in a hospital under Medicare. Financial 
interests that are disclosable under Medicare are determined in 
accordance with the provisions of part 420, subpart C, of this chapter.

[84 FR 51882, Sept. 30, 2019]



Sec. 482.45  Condition of participation: Organ, tissue, and eye
procurement.

    (a) Standard: Organ procurement responsibilities. The hospital must 
have and implement written protocols that:
    (1) Incorporate an agreement with an OPO designated under part 486 
of this chapter, under which it must notify, in a timely manner, the OPO 
or a third party designated by the OPO of individuals whose death is 
imminent or who have died in the hospital. The OPO determines medical 
suitability for organ donation and, in the absence of alternative 
arrangements by the hospital, the OPO determines medical suitability for 
tissue and eye donation, using the definition of potential tissue and 
eye donor and the notification protocol developed in consultation with 
the tissue and eye banks identified by the hospital for this purpose;
    (2) Incorporate an agreement with at least one tissue bank and at 
least one eye bank to cooperate in the retrieval, processing, 
preservation, storage and distribution of tissues and eyes, as may be 
appropriate to assure that all usable tissues and eyes are obtained from 
potential donors, insofar as such an agreement does not interfere with 
organ procurement;

[[Page 37]]

    (3) Ensure, in collaboration with the designated OPO, that the 
family of each potential donor is informed of its options to donate 
organs, tissues, or eyes or to decline to donate. The individual 
designated by the hospital to initiate the request to the family must be 
an organ procurement representative or a designated requestor. A 
designated requestor is an individual who has completed a course offered 
or approved by the OPO and designed in conjunction with the tissue and 
eye bank community in the methodology for approaching potential donor 
families and requesting organ or tissue donation;
    (4) Encourage discretion and sensitivity with respect to the 
circumstances, views, and beliefs of the families of potential donors;
    (5) Ensure that the hospital works cooperatively with the designated 
OPO, tissue bank and eye bank in educating staff on donation issues, 
reviewing death records to improve identification of potential donors, 
and maintaining potential donors while necessary testing and placement 
of potential donated organs, tissues, and eyes take place.
    (b) Standard: Organ transplantation responsibilities. (1) A hospital 
in which organ transplants are performed must be a member of the Organ 
Procurement and Transplantation Network (OPTN) established and operated 
in accordance with section 372 of the Public Health Service (PHS) Act 
(42 U.S.C. 274) and abide by its rules. The term ``rules of the OPTN'' 
means those rules provided for in regulations issued by the Secretary in 
accordance with section 372 of the PHS Act which are enforceable under 
42 CFR 121.10. No hospital is considered to be out of compliance with 
section 1138(a)(1)(B) of the Act, or with the requirements of this 
paragraph, unless the Secretary has given the OPTN formal notice that he 
or she approves the decision to exclude the hospital from the OPTN and 
has notified the hospital in writing.
    (2) For purposes of these standards, the term ``organ'' means a 
human kidney, liver, heart, lung, or pancreas.
    (3) If a hospital performs any type of transplants, it must provide 
organ-transplant-related data, as requested by the OPTN, the Scientific 
Registry, and the OPOs. The hospital must also provide such data 
directly to the Department when requested by the Secretary.

[63 FR 33875, June 22, 1998]



                  Subpart D_Optional Hospital Services



Sec. 482.51  Condition of participation: Surgical services.

    If the hospital provides surgical services, the services must be 
well organized and provided in accordance with acceptable standards of 
practice. If outpatient surgical services are offered the services must 
be consistent in quality with inpatient care in accordance with the 
complexity of services offered.
    (a) Standard: Organization and staffing. The organization of the 
surgical services must be appropriate to the scope of the services 
offered.
    (1) The operating rooms must be supervised by an experienced 
registered nurse or a doctor of medicine or osteopathy.
    (2) Licensed practical nurses (LPNs) and surgical technologists 
(operating room technicians) may serve as ``scrub nurses'' under the 
supervision of a registered nurse.
    (3) Qualified registered nurses may perform circulating duties in 
the operating room. In accordance with applicable State laws and 
approved medical staff policies and procedures, LPNs and surgical 
technologists may assist in circulatory duties under the surpervision of 
a qualified registered nurse who is immediately available to respond to 
emergencies.
    (4) Surgical privileges must be delineated for all practitioners 
performing surgery in accordance with the competencies of each 
practitioner. The surgical service must maintain a roster of 
practitioners specifying the surgical privileges of each practitioner.
    (b) Standard: Delivery of service. Surgical services must be 
consistent with needs and resources. Policies governing surgical care 
must be designed to assure the achievement and maintenance of high 
standards of medical practice and patient care.
    (1) Prior to surgery or a procedure requiring anesthesia services 
and except in the case of emergencies:

[[Page 38]]

    (i) A medical history and physical examination must be completed and 
documented no more than 30 days before or 24 hours after admission or 
registration, and except as provided under paragraph (b)(1)(iii) of this 
section.
    (ii) An updated examination of the patient, including any changes in 
the patient's condition, must be completed and documented within 24 
hours after admission or registration when the medical history and 
physical examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (b)(1)(iii) of this 
section.
    (iii) An assessment of the patient must be completed and documented 
after registration (in lieu of the requirements of paragraphs (b)(1)(i) 
and (ii) of this section) when the patient is receiving specific 
outpatient surgical or procedural services and when the medical staff 
has chosen to develop and maintain a policy that identifies, in 
accordance with the requirements at Sec. 482.22(c)(5)(v), specific 
patients as not requiring a comprehensive medical history and physical 
examination, or any update to it, prior to specific outpatient surgical 
or procedural services.
    (2) A properly executed informed consent form for the operation must 
be in the patient's chart before surgery, except in emergencies.
    (3) The following equipment must be available to the operating room 
suites: call-in-system, cardiac monitor, resuscitator, defibrillator, 
aspirator, and tracheotomy set.
    (4) There must be adequate provisions for immediate post-operative 
care.
    (5) The operating room register must be complete and up-to-date.
    (6) An operative report describing techniques, findings, and tissues 
removed or altered must be written or dictated immediately following 
surgery and signed by the surgeon.

[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007; 
84 FR 51821, Sept. 30, 2019]



Sec. 482.52  Condition of participation: Anesthesia services.

    If the hospital furnishes anesthesia services, they must be provided 
in a well-organized manner under the direction of a qualified doctor of 
medicine or osteopathy. The service is responsible for all anesthesia 
administered in the hospital.
    (a) Standard: Organization and staffing. The organization of 
anesthesia services must be appropriate to the scope of the services 
offered. Anesthesia must be administered only by--
    (1) A qualified anesthesiologist;
    (2) A doctor of medicine or osteopathy (other than an 
anesthesiologist);
    (3) A dentist, oral surgeon, or podiatrist who is qualified to 
administer anesthesia under State law;
    (4) A certified registered nurse anesthetist (CRNA), as defined in 
Sec. 410.69(b) of this chapter, who, unless exempted in accordance with 
paragraph (c)of this section, is under the supervision of the operating 
practitioner or of an anesthesiologist who is immediately available if 
needed; or
    (5) An anesthesiologist's assistant, as defined in Sec. 410.69(b) 
of this chapter, who is under the supervision of an anesthesiologist who 
is immediately available if needed.
    (b) Standard: Delivery of services. Anesthesia services must be 
consistent with needs and resources. Policies on anesthesia procedures 
must include the delineation of preanesthesia and post anesthesia 
responsibilities. The policies must ensure that the following are 
provided for each patient:
    (1) A preanesthesia evaluation completed and documented by an 
individual qualified to administer anesthesia, as specified in paragraph 
(a) of this section, performed within 48 hours prior to surgery or a 
procedure requiring anesthesia services.
    (2) An intraoperative anesthesia record.
    (3) A postanesthesia evaluation completed and documented by an 
individual qualified to administer anesthesia, as specified in paragraph 
(a) of this section, no later than 48 hours after surgery or a procedure 
requiring anesthesia services. The postanesthesia evaluation for 
anesthesia recovery must be completed in accordance with State law and 
with hospital policies and procedures that have been approved by the 
medical staff and that reflect current standards of anesthesia care.

[[Page 39]]

    (c) Standard: State exemption. (1) A hospital may be exempted from 
the requirement for physician supervision of CRNAs as described in 
paragraph (a)(4) of this section, if the State in which the hospital is 
located submits a letter to CMS signed by the Governor, following 
consultation with the State's Boards of Medicine and Nursing, requesting 
exemption from physician supervision of CRNAs. The letter from the 
Governor must attest that he or she has consulted with State Boards of 
Medicine and Nursing about issues related to access to and the quality 
of anesthesia services in the State and has concluded that it is in the 
best interests of the State's citizens to opt-out of the current 
physician supervision requirement, and that the opt-out is consistent 
with State law.
    (2) The request for exemption and recognition of State laws, and the 
withdrawal of the request may be submitted at any time, and are 
effective upon submission.

[51 FR 22042, June 17, 1986, as amended at 57 FR 33900, July 31, 1992; 
66 FR 56769, Nov. 13, 2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, 
Nov. 27, 2007]



Sec. 482.53  Condition of participation: Nuclear medicine services.

    If the hospital provides nuclear medicine services, those services 
must meet the needs of the patients in accordance with acceptable 
standards of practice.
    (a) Standard: Organization and staffing. The organization of the 
nuclear medicine service must be appropriate to the scope and complexity 
of the services offered.
    (1) There must be a director who is a doctor of medicine or 
osteopathy qualified in nuclear medicine.
    (2) The qualifications, training, functions, and responsibilities of 
nuclear medicine personnel must be specified by the service director and 
approved by the medical staff.
    (b) Standard: Delivery of service. Radioactive materials must be 
prepared, labeled, used, transported, stored, and disposed of in 
accordance with acceptable standards of practice.
    (1) In-house preparation of radiopharmaceuticals is by, or under the 
supervision of, an appropriately trained registered pharmacist or a 
doctor of medicine or osteopathy.
    (2) There is proper storage and disposal of radioactive material.
    (3) If laboratory tests are performed in the nuclear medicine 
service, the service must meet the applicable requirement for laboratory 
services specified in Sec. 482.27.
    (c) Standard: Facilities. Equipment and supplies must be appropriate 
for the types of nuclear medicine services offered and must be 
maintained for safe and efficient performance. The equipment must be--
    (1) Maintained in safe operating condition; and
    (2) Inspected, tested, and calibrated at least annually by qualified 
personnel.
    (d) Standard: Records. The hospital must maintain signed and dated 
reports of nuclear medicine interpretations, consultations, and 
procedures.
    (1) The hospital must maintain copies of nuclear medicine reports 
for at least 5 years.
    (2) The practitioner approved by the medical staff to interpret 
diagnostic procedures must sign and date the interpretation of these 
tests.
    (3) The hospital must maintain records of the receipt and 
disposition of radiopharmaceuticals.
    (4) Nuclear medicine services must be ordered only by practitioner 
whose scope of Federal or State licensure and whose defined staff 
privileges allow such referrals.

[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992; 79 
FR 27154, May 12, 2014]



Sec. 482.54  Condition of participation: Outpatient services.

    If the hospital provides outpatient services, the services must meet 
the needs of the patients in accordance with acceptable standards of 
practice.
    (a) Standard: Organization. Outpatient services must be 
appropriately organized and integrated with inpatient services.
    (b) Standard: Personnel. The hospital must--
    (1) Assign one or more individuals to be responsible for outpatient 
services.
    (2) Have appropriate professional and nonprofessional personnel 
available at

[[Page 40]]

each location where outpatient services are offered, based on the scope 
and complexity of outpatient services.
    (c) Standard: Orders for outpatient services. Outpatient services 
must be ordered by a practitioner who meets the following conditions:
    (1) Is responsible for the care of the patient.
    (2) Is licensed in the State where he or she provides care to the 
patient.
    (3) Is acting within his or her scope of practice under State law.
    (4) Is authorized in accordance with State law and policies adopted 
by the medical staff, and approved by the governing body, to order the 
applicable outpatient services. This applies to the following:
    (i) All practitioners who are appointed to the hospital's medical 
staff and who have been granted privileges to order the applicable 
outpatient services.
    (ii) All practitioners not appointed to the medical staff, but who 
satisfy the above criteria for authorization by the medical staff and 
the hospital for ordering the applicable outpatient services for their 
patients.

[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79 
FR 27154, May 12, 2014]



Sec. 482.55  Condition of participation: Emergency services.

    The hospital must meet the emergency needs of patients in accordance 
with acceptable standards of practice.
    (a) Standard: Organization and direction. If emergency services are 
provided at the hospital--
    (1) The services must be organized under the direction of a 
qualified member of the medical staff;
    (2) The services must be integrated with other departments of the 
hospital;
    (3) The policies and procedures governing medical care provided in 
the emergency service or department are established by and are a 
continuing responsibility of the medical staff.
    (b) Standard: Personnel. (1) The emergency services must be 
supervised by a qualified member of the medical staff.
    (2) There must be adequate medical and nursing personnel qualified 
in emergency care to meet the written emergency procedures and needs 
anticipated by the facility.



Sec. 482.56  Condition of participation: Rehabilitation services.

    If the hospital provides rehabilitation, physical therapy, 
occupational therapy, audiology, or speech pathology services, the 
services must be organized and staffed to ensure the health and safety 
of patients.
    (a) Standard: Organization and staffing. The organization of the 
service must be appropriate to the scope of the services offered.
    (1) The director of the services must have the necessary knowledge, 
experience, and capabilities to properly supervise and administer the 
services.
    (2) Physical therapy, occupational therapy, speech-language 
pathology or audiology services, if provided, must be provided by 
qualified physical therapists, physical therapist assistants, 
occupational therapists, occupational therapy assistants, speech-
language pathologists, or audiologists as defined in part 484 of this 
chapter.
    (b) Standard: Delivery of services. Services must only be provided 
under the orders of a qualified and licensed practitioner who is 
responsible for the care of the patient, acting within his or her scope 
of practice under State law, and who is authorized by the hospital's 
medical staff to order the services in accordance with hospital policies 
and procedures and State laws.
    (1) All rehabilitation services orders must be documented in the 
patient's medical record in accordance with the requirements at Sec. 
482.24.
    (2) The provision of care and the personnel qualifications must be 
in accordance with national acceptable standards of practice and must 
also meet the requirements of Sec. 409.17 of this chapter.

[51 FR 22042, June 17, 1986, as amended at 72 FR 66406, Nov. 27, 2007; 
75 FR 50418, Aug. 16, 2010]



Sec. 482.57  Condition of participation: Respiratory care services.

    The hospital must meet the needs of the patients in accordance with 
acceptable standards of practice. The following requirements apply if 
the hospital provides respiratory care service.

[[Page 41]]

    (a) Standard: Organization and Staffing. The organization of the 
respiratory care services must be appropriate to the scope and 
complexity of the services offered.
    (1) There must be a director of respiratory care services who is a 
doctor of medicine or osteopathy with the knowledge experience, and 
capabilities to supervise and administer the service properly. The 
director may serve on either a full-time or part-time basis.
    (2) There must be adequate numbers of respiratory therapists, 
respiratory therapy technicians, and other personnel who meet the 
qualifications specified by the medical staff, consistent with State 
law.
    (b) Standard: Delivery of Services. Services must be delivered in 
accordance with medical staff directives.
    (1) Personnel qualified to perform specific procedures and the 
amount of supervision required for personnel to carry out specific 
procedures must be designated in writing.
    (2) If blood gases or other laboratory tests are performed in the 
respiratory care unit, the unit must meet the applicable requirements 
for laboratory services specified in Sec. 482.27.
    (3) Services must only be provided under the orders of a qualified 
and licensed practitioner who is responsible for the care of the 
patient, acting within his or her scope of practice under State law, and 
who is authorized by the hospital's medical staff to order the services 
in accordance with hospital policies and procedures and State laws.
    (4) All respiratory care services orders must be documented in the 
patient's medical record in accordance with the requirements at Sec. 
482.24.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 
FR 7136, Feb. 28, 1992; 75 FR 50418, Aug. 16, 2010]



Sec. 482.58  Special requirements for hospital providers of long-term
care services (``swing-beds'').

    A hospital that has a Medicare provider agreement must meet the 
following requirements in order to be granted an approval from CMS to 
provide post-hospital extended care services, as specified in Sec. 
409.30 of this chapter, and be reimbursed as a swing-bed hospital, as 
specified in Sec. 413.114 of this chapter:
    (a) Eligibility. A hospital must meet the following eligibility 
requirements:
    (1) The facility has fewer than 100 hospital beds, excluding beds 
for newborns and beds in intensive care type inpatient units (for 
eligibility of hospitals with distinct parts electing the optional 
reimbursement method, see Sec. 413.24(d)(5) of this chapter).
    (2) The hospital is located in a rural area. This includes all areas 
not delineated as ``urbanized'' areas by the Census Bureau, based on the 
most recent census.
    (3) The hospital does not have in effect a 24-hour nursing waiver 
granted under Sec. 488.54(c) of this chapter.
    (4) The hospital has not had a swing-bed approval terminated within 
the two years previous to application.
    (b) Skilled nursing facility services. The facility is substantially 
in compliance with the following skilled nursing facility requirements 
contained in subpart B of part 483 of this chapter.
    (1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii), 
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (h), (g)(8) and (17), 
and (g)(18) introductory text of this chapter).
    (2) Admission, transfer, and discharge rights (Sec. 483.5 
definition of transfer and discharge, Sec. 483.15(c)(1), (c)(2)(i), 
(c)(2)(ii), (c)(3), (c)(4), (c)(5), and (c)(7)).
    (3) Freedom from abuse, neglect, and exploitation (Sec. 
483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), 
(c)).
    (4) Social services (Sec. 483.40(d) of this chapter).
    (5) Discharge summary (Sec. 483.20(l)).
    (6) Specialized rehabilitative services (Sec. 483.65).
    (7) Dental services (Sec. 483.55(a)(2), (3), (4), and (5) and (b) 
of this chapter).

[72 FR 60788, Oct. 26, 2007. Redesignated at 79 FR 27155, May 12, 2014, 
as amended at 81 FR 68847, Oct. 4, 2016; 82 FR 32258, July 13, 2017; 84 
FR 51821, Sept. 30, 2019]



             Subpart E_Requirements for Specialty Hospitals

    Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

[[Page 42]]



Sec. 482.60  Special provisions applying to psychiatric hospitals.

    Psychiatric hospital must--
    (a) Be primarily engaged in providing, by or under the supervision 
of a doctor of medicine or osteopathy, psychiatric services for the 
diagnosis and treatment of mentally ill persons;
    (b) Meet the conditions of participation specified in Sec. Sec. 
482.1 through 482.23 and Sec. Sec. 482.25 through 482.57;
    (c) Maintain clinical records on all patients, including records 
sufficient to permit CMS to determine the degree and intensity of 
treatment furnished to Medicare beneficiaries, as specified in Sec. 
482.61; and
    (d) Meet the staffing requirements specified in Sec. 482.62.

[72 FR 60788, Oct. 26, 2007]



Sec. 482.61  Condition of participation: Special medical record 
requirements for psychiatric hospitals.

    The medical records maintained by a psychiatric hospital must permit 
determination of the degree and intensity of the treatment provided to 
individuals who are furnished services in the institution.
    (a) Standard: Development of assessment/diagnostic data. Medical 
records must stress the psychiatric components of the record, including 
history of findings and treatment provided for the psychiatric condition 
for which the patient is hospitalized.
    (1) The identification data must include the patient's legal status.
    (2) A provisional or admitting diagnosis must be made on every 
patient at the time of admission, and must include the diagnoses of 
intercurrent diseases as well as the psychiatric diagnoses.
    (3) The reasons for admission must be clearly documented as stated 
by the patient and/or others significantly involved.
    (4) The social service records, including reports of interviews with 
patients, family members, and others, must provide an assessment of home 
plans and family attitudes, and community resource contacts as well as a 
social history.
    (5) When indicated, a complete neurological examination must be 
recorded at the time of the admission physical examination.
    (b) Standard: Psychiatric evaluation. Each patient must receive a 
psychiatric evaluation that must--
    (1) Be completed within 60 hours of admission;
    (2) Include a medical history;
    (3) Contain a record of mental status;
    (4) Note the onset of illness and the circumstances leading to 
admission;
    (5) Describe attitudes and behavior;
    (6) Estimate intellectual functioning, memory functioning, and 
orientation; and
    (7) Include an inventory of the patient's assets in descriptive, not 
interpretative, fashion.
    (c) Standard: Treatment plan. (1) Each patient must have an 
individual comprehensive treatment plan that must be based on an 
inventory of the patient's strengths and disabilities. The written plan 
must include--
    (i) A substantiated diagnosis;
    (ii) Short-term and long-range goals;
    (iii) The specific treatment modalities utilized;
    (iv) The responsibilities of each member of the treatment team; and
    (v) Adequate documentation to justify the diagnosis and the 
treatment and rehabilitation activities carried out.
    (2) The treatment received by the patient must be documented in such 
a way to assure that all active therapeutic efforts are included.
    (d) Standard: Recording progress. Progress notes for the patient 
must be documented, in accordance with applicable State scope-of-
practice laws and hospital policies, by the following qualified 
practitioners: Doctor(s) of medicine or osteopathy, or other licensed 
practitioner(s), who is responsible for the care of the patient; 
nurse(s) and social worker(s) (or social service staff) involved in the 
care of the patient; and, when appropriate, others significantly 
involved in the patient's active treatment modalities. The frequency of 
progress notes is determined by the condition of the patient but must be 
recorded at least weekly for the first 2 months and at least once a 
month thereafter and must contain recommendations for revisions in the 
treatment plan as indicated, as

[[Page 43]]

well as precise assessment of the patient's progress in accordance with 
the original or revised treatment plan.
    (e) Standard: Discharge planning and discharge summary. The record 
of each patient who has been discharged must have a discharge summary 
that includes a recapitulation of the patient's hospitalization and 
recommendations from appropriate services concerning follow-up or 
aftercare as well as a brief summary of the patient's condition on 
discharge.
    (f) Standard: Electronic notifications. If the hospital utilizes an 
electronic medical records system or other electronic administrative 
system, which is conformant with the content exchange standard at 45 CFR 
170.205(d)(2), then the hospital must demonstrate that--
    (1) The system's notification capacity is fully operational and the 
hospital uses it in accordance with all State and Federal statutes and 
regulations applicable to the hospital's exchange of patient health 
information.
    (2) The system sends notifications that must include at least 
patient name, treating practitioner name, and sending institution name.
    (3) To the extent permissible under applicable federal and state law 
and regulations, and not inconsistent with the patient's expressed 
privacy preferences, the system sends notifications directly, or through 
an intermediary that facilitates exchange of health information, at the 
time of:
    (i) The patient's registration in the hospital's emergency 
department (if applicable).
    (ii) The patient's admission to the hospital's inpatient services 
(if applicable).
    (4) To the extent permissible under applicable federal and state law 
and regulations, and not inconsistent with the patient's expressed 
privacy preferences, the system sends notifications directly, or through 
an intermediary that facilitates exchange of health information, either 
immediately prior to, or at the time of:
    (i) The patient's discharge or transfer from the hospital's 
emergency department (if applicable).
    (ii) The patient's discharge or transfer from the hospital's 
inpatient services (if applicable).
    (5) The hospital has made a reasonable effort to ensure that the 
system sends the notifications to all applicable post-acute care 
services providers and suppliers, as well as to any of the following 
practitioners and entities, which need to receive notification of the 
patient's status for treatment, care coordination, or quality 
improvement purposes:
    (i) The patient's established primary care practitioner;
    (ii) The patient's established primary care practice group or 
entity; or
    (iii) Other practitioner, or other practice group or entity, 
identified by the patient as the practitioner, or practice group or 
entity, primarily responsible for his or her care.

[72 FR 60788, Oct. 26, 2007, as amended at 84 FR 51821, Sept. 30, 2019; 
85 FR 19292, Apr. 6, 2020; 85 FR 25637, May 1, 2020]



Sec. 482.62  Condition of participation: Special staff requirements
for psychiatric hospitals.

    The hospital must have adequate numbers of qualified professional 
and supportive staff to evaluate patients, formulate written, 
individualized comprehensive treatment plans, provide active treatment 
measures, and engage in discharge planning.
    (a) Standard: Personnel. The hospital must employ or undertake to 
provide adequate numbers of qualified professional, technical, and 
consultative personnel to:
    (1) Evaluate patients;
    (2) Formulate written individualized, comprehensive treatment plans;
    (3) Provide active treatment measures; and
    (4) Engage in discharge planning.
    (b) Standard: Director of inpatient psychiatric services; medical 
staff. Inpatient psychiatric services must be under the supervision of a 
clinical director, service chief, or equivalent who is qualified to 
provide the leadership required for an intensive treatment program. The 
number and qualifications of doctors of medicine and osteopathy must be 
adequate to provide essential psychiatric services.
    (1) The clinical director, service chief, or equivalent must meet 
the training and experience requirements for examination by the American

[[Page 44]]

Board of Psychiatry and Neurology or the American Osteopathic Board of 
Neurology and Psychiatry.
    (2) The director must monitor and evaluate the quality and 
appropriateness of services and treatment provided by the medical staff.
    (c) Standard: Availability of medical personnel. Doctors of medicine 
or osteopathy and other appropriate professional personnel must be 
available to provide necessary medical and surgical diagnostic and 
treatment services. If medical and surgical diagnostic and treatment 
services are not available within the institution, the institution must 
have an agreement with an outside source of these services to ensure 
that they are immediately available or a satisfactory agreement must be 
established for transferring patients to a general hospital that 
participates in the Medicare program.
    (d) Standard: Nursing services. The hospital must have a qualified 
director of psychiatric nursing services. In addition to the director of 
nursing, there must be adequate numbers of registered nurses, licensed 
practical nurses, and mental health workers to provide nursing care 
necessary under each patient's active treatment program and to maintain 
progress notes on each patient.
    (1) The director of psychiatric nursing services must be a 
registered nurse who has a master's degree in psychiatric or mental 
health nursing, or its equivalent from a school of nursing accredited by 
the National League for Nursing, or be qualified by education and 
experience in the care of the mentally ill. The director must 
demonstrate competence to participate in interdisciplinary formulation 
of individual treatment plans; to give skilled nursing care and therapy; 
and to direct, monitor, and evaluate the nursing care furnished.
    (2) The staffing pattern must insure the availability of a 
registered professional nurse 24 hours each day. There must be adequate 
numbers of registered nurses, licensed practical nurses, and mental 
health workers to provide the nursing care necessary under each 
patient's active treatment program.
    (e) Standard: Psychological services. The hospital must provide or 
have available psychological services to meet the needs of the patients.
    (f) Standard: Social services. There must be a director of social 
services who monitors and evaluates the quality and appropriateness of 
social services furnished. The services must be furnished in accordance 
with accepted standards of practice and established policies and 
procedures.
    (1) The director of the social work department or service must have 
a master's degree from an accredited school of social work or must be 
qualified by education and experience in the social services needs of 
the mentally ill. If the director does not hold a masters degree in 
social work, at least one staff member must have this qualification.
    (2) Social service staff responsibilities must include, but are not 
limited to, participating in discharge planning, arranging for follow-up 
care, and developing mechanisms for exchange of appropriate, information 
with sources outside the hospital.
    (g) Standard: Therapeutic activities. The hospital must provide a 
therapeutic activities program.
    (1) The program must be appropriate to the needs and interests of 
patients and be directed toward restoring and maintaining optimal levels 
of physical and psychosocial functioning.
    (2) The number of qualified therapists, support personnel, and 
consultants must be adequate to provide comprehensive therapeutic 
activities consistent with each patient's active treatment program.

[72 FR 60788, Oct. 26, 2007]



Sec. 482.68  Special requirement for transplant programs.

    A transplant program located within a hospital that has a Medicare 
provider agreement must meet the conditions of participation specified 
in Sec. Sec. 482.72 through 482.104 in order to be granted approval 
from CMS to provide transplant services.
    (a) Unless specified otherwise, the conditions of participation at 
Sec. Sec. 482.72 through 482.104 apply to heart, heart-lung, intestine, 
kidney, liver, lung, and pancreas centers.

[[Page 45]]

    (b) In addition to meeting the conditions of participation specified 
in Sec. Sec. 482.72 through 482.104, a transplant program must also 
meet the conditions of participation in Sec. Sec. 482.1 through 482.57, 
except for Sec. 482.15.

[81 FR 64030, Sept. 16, 2016, as amended at 84 FR 51821, Sept. 30, 2019]



Sec. 482.70  Definitions.

    As used in this subpart, the following definitions apply:
    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury, or the risk 
thereof. As applied to transplant programs, examples of adverse events 
include (but are not limited to) serious medical complications or death 
caused by living donation; unintentional transplantation of organs of 
mismatched blood types; transplantation of organs to unintended 
beneficiaries; and unintended transmission of infectious disease to a 
beneficiary.
    End-Stage Renal Disease (ESRD) means that stage of renal impairment 
that appears irreversible and permanent, and requires a regular course 
of dialysis or kidney transplantation to maintain life.
    ESRD Network means all Medicare-approved ESRD facilities in a 
designated geographic area specified by CMS.
    Heart-Lung transplant program means a transplant program that is 
located in a hospital with an existing Medicare-approved heart 
transplant program and an existing Medicare-approved lung program that 
performs combined heart-lung transplants.
    Intestine transplant program means a Medicare-approved liver 
transplant program that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
    Network organization means the administrative governing body to the 
network and liaison to the Federal government.
    Pancreas transplant program means a Medicare-approved kidney 
transplant program that performs pancreas transplants alone or 
subsequent to a kidney transplant as well as kidney-pancreas 
transplants.
    Transplant hospital means a hospital that furnishes organ 
transplants and other medical and surgical specialty services required 
for the care of transplant patients.
    Transplant program means an organ-specific transplant program within 
a transplant hospital (as defined in this section).

[51 FR 22042, June 17, 1986, as amended at 84 FR 51821, Sept. 30, 2019]

               General Requirements for Transplant Centers



Sec. 482.72  Condition of participation: OPTN membership.

    A transplant program must be located in a transplant hospital that 
is a member of and abides by the rules and requirements of the Organ 
Procurement and Transplantation Network (OPTN) established and operated 
in accordance with section 372 of the Public Health Service (PHS) Act 
(42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means 
those rules and requirements approved by the Secretary pursuant to Sec. 
121.4 of this title. No hospital that provides transplantation services 
shall be deemed to be out of compliance with section 1138(a)(1)(B) of 
the Act or this section unless the Secretary has given the OPTN formal 
notice that he or she approves the decision to exclude the transplant 
hospital from the OPTN and also has notified the transplant hospital in 
writing.

[51 FR 22042, June 17, 1986, as amended at 84 FR 51822, Sept. 30, 2019]



Sec. 482.74  Condition of participation: Notification to CMS.

    (a) A transplant program must notify CMS immediately of any 
significant changes related to the hospital's transplant program or 
changes that could affect its compliance with the conditions of 
participation. Instances in which CMS should receive information for 
follow up, as appropriate, include, but are not limited to:
    (1) Change in key staff members of the transplant team, such as a 
change in the individual the transplant program designated to the OPTN 
as the program's ``primary transplant surgeon'' or ``primary transplant 
physician;'

[[Page 46]]

    (2) Termination of an agreement between the hospital in which the 
transplant program is located and an OPO for the recovery and receipt of 
organs as required by section 482.100; and
    (3) Inactivation of the transplant program.
    (b) Upon receiving notification of significant changes, CMS will 
follow up with the transplant program as appropriate, including (but not 
limited to):
    (1) Requesting additional information;
    (2) Analyzing the information; or
    (3) Conducting an on-site review.

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 84 
FR 51822, Sept. 30, 2019]



Sec. 482.76  Condition of participation: Pediatric Transplants.

    A transplant center that seeks Medicare approval to provide 
transplantation services to pediatric patients must submit to CMS a 
request specifically for Medicare approval to perform pediatric 
transplants using the procedures described at Sec. 488.61 of this 
chapter.
    (a) Except as specified in paragraph (d) of this section, a center 
requesting Medicare approval to perform pediatric transplants must meet 
all the conditions of participation at Sec. Sec. 482.72 through 482.74 
and Sec. Sec. 482.80 through 482.104 with respect to its pediatric 
patients.
    (b) A center that performs 50 percent or more of its transplants in 
a 12-month period on adult patients must be approved to perform adult 
transplants in order to be approved to perform pediatric transplants.
    (1) Loss of Medicare approval to perform adult transplants, whether 
voluntary or involuntary, will result in loss of the center's approval 
to perform pediatric transplants.
    (2) Loss of Medicare approval to perform pediatric transplants, 
whether voluntary or involuntary, may trigger a review of the center's 
Medicare approval to perform adult transplants.
    (c) A center that performs 50 percent or more of its transplants in 
a 12-month period on pediatric patients must be approved to perform 
pediatric transplants in order to be approved to perform adult 
transplants.
    (1) Loss of Medicare approval to perform pediatric transplants, 
whether voluntary or involuntary, will result in loss of the center's 
approval to perform adult transplants.
    (2) Loss of Medicare approval to perform adult transplants, whether 
voluntary or involuntary, may trigger a review of the center's Medicare 
approval to perform pediatric transplants.
    (3) A center that performs 50 percent or more of its transplants on 
pediatric patients in a 12-month period is not required to meet the 
clinical experience requirements prior to its request for approval as a 
pediatric transplant center.
    (d) Instead of meeting all conditions of participation at Sec. Sec. 
482.72 through 482.74 and Sec. Sec. 482.80 through 482.104, a heart 
transplant center that wishes to provide transplantation services to 
pediatric heart patients may be approved to perform pediatric heart 
transplants by meeting the Omnibus Budget Reconciliation Act of 1987 
criteria in section 4009(b) (Pub. L. 100-203), as follows:
    (1) The center's pediatric transplant program must be operated 
jointly by the hospital and another facility that is Medicare-approved;
    (2) The unified program shares the same transplant surgeons and 
quality improvement program (including oversight committee, patient 
protocol, and patient selection criteria); and
    (3) The center demonstrates to the satisfaction of the Secretary 
that it is able to provide the specialized facilities, services, and 
personnel that are required by pediatric heart transplant patients.



Sec. 482.78  Condition of participation: Emergency preparedness for
transplant programs.

    A transplant program must be included in the emergency preparedness 
planning and the emergency preparedness program as set forth in Sec. 
482.15 for the hospital in which it is located. However, a transplant 
program is not individually responsible for the emergency preparedness 
requirements set forth in Sec. 482.15.

[[Page 47]]

    (a) Standard: Policies and procedures. A transplant program must 
have policies and procedures that address emergency preparedness. These 
policies and procedures must be included in the hospital's emergency 
preparedness program.
    (b) Standard: Protocols with hospital and OPO. A transplant program 
must develop and maintain mutually agreed upon protocols that address 
the duties and responsibilities of the transplant program, the hospital 
in which the transplant program is operated, and the OPO designated by 
the Secretary, unless the hospital has an approved waiver to work with 
another OPO, during an emergency.

[81 FR 64030, Sept. 16, 2016, as amended at 84 FR 51822, Sept. 30, 2019]

  Transplant Center Data Submission, Clinical Experience, and Outcome 
                              Requirements



Sec. 482.80  Condition of participation: Data submission, clinical
experience, and outcome requirements for initial approval of 
transplant programs.

    Except as specified in paragraph (d) of this section, and Sec. 
488.61 of this chapter, transplant programs must meet all data 
submission, clinical experience, and outcome requirements to be granted 
initial approval by CMS.
    (a) Standard: Data submission. No later than 90 days after the due 
date established by the OPTN, a transplant program must submit to the 
OPTN at least 95 percent of required data on all transplants (deceased 
and living donor) it has performed. Required data submissions include, 
but are not limited to, submission of the appropriate OPTN forms for 
transplant candidate registration, transplant recipient registration and 
follow-up, and living donor registration and follow-up.
    (b) Standard: Clinical experience. To be considered for initial 
approval, an organ-specific transplant program must generally perform 10 
transplants over a 12-month period.
    (c) Standard: Outcome requirements. CMS will review outcomes for all 
transplants performed at a program, including outcomes for living donor 
transplants, if applicable. CMS will review adult and pediatric outcomes 
separately when a program requests Medicare approval to perform both 
adult and pediatric transplants.
    (1) CMS will compare each transplant program's observed number of 
patient deaths and graft failures 1-year post-transplant to the center's 
expected number of patient deaths and graft failures 1-year post-
transplant using the data contained in the most recent Scientific 
Registry of Transplant Recipients (SRTR) program-specific report.
    (2) CMS will not consider a program's patient and graft survival 
rates to be acceptable if:
    (i) A program's observed patient survival rate or observed graft 
survival rate is lower than its expected patient survival rate or 
expected graft survival rate; and
    (ii) All three of the following thresholds are crossed over:
    (A) The one-sided p-value is less than 0.05,
    (B) The number of observed events (patient deaths or graft failures) 
minus the number of expected events is greater than 3, and
    (C) The number of observed events divided by the number of expected 
events is greater than 1.85.
    (d) Exceptions. (1) A heart-lung transplant program is not required 
to comply with the clinical experience requirements in paragraph (b) of 
this section or the outcome requirements in paragraph (c) of this 
section for heart-lung transplants performed at the program.
    (2) An intestine transplant program is not required to comply with 
the outcome performance requirements in paragraph (c) of this section 
for intestine, combined liver-intestine or multivisceral transplants 
performed at the program.
    (3) A pancreas transplant program is not required to comply with the 
clinical experience requirements in paragraph (b) of this section or the 
outcome requirements in paragraph (c) of this section for pancreas 
transplants performed at the program.
    (4) A program that is requesting initial Medicare approval to 
perform pediatric transplants is not required to

[[Page 48]]

comply with the clinical experience requirements in paragraph (b) of 
this section prior to its request for approval as a pediatric transplant 
program.
    (5) A kidney transplant program that is not Medicare-approved on the 
effective date of this rule is required to perform at least 3 
transplants over a 12-month period prior to its request for initial 
approval.

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81 
FR 79880, Nov. 14, 2016; 84 FR 51822, Sept. 30, 2019]

                 Transplant Program Process Requirements



Sec. 482.90  Condition of participation: Patient and living donor 
selection.

    The transplant program must use written patient selection criteria 
in determining a patient's suitability for placement on the waiting list 
or a patient's suitability for transplantation. If a program performs 
living donor transplants, the program also must use written donor 
selection criteria in determining the suitability of candidates for 
donation.
    (a) Standard: Patient selection. Patient selection criteria must 
ensure fair and non-discriminatory distribution of organs.
    (1) Prior to placement on the program's waiting list, a prospective 
transplant candidate must receive a psychosocial evaluation, if 
possible.
    (2) Before a transplant program places a transplant candidate on its 
waiting list, the candidate's medical record must contain documentation 
that the candidate's blood type has been determined.
    (3) When a patient is placed on a program's waiting list or is 
selected to receive a transplant, the center must document in the 
patient's medical record the patient selection criteria used.
    (4) A transplant program must provide a copy of its patient 
selection criteria to a transplant patient, or a dialysis facility, as 
requested by a patient or a dialysis facility.
    (b) Standard: Living donor selection. The living donor selection 
criteria must be consistent with the general principles of medical 
ethics. Transplant programs must:
    (1) Ensure that a prospective living donor receives a medical and 
psychosocial evaluation prior to donation,
    (2) Document in the living donor's medical records the living 
donor's suitability for donation, and
    (3) Document that the living donor has given informed consent, as 
required under Sec. 482.102.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]



Sec. 482.92  Condition of participation: Organ recovery and receipt.

    Transplant programs must have written protocols for validation of 
donor-recipient blood type and other vital data for the deceased organ 
recovery, organ receipt, and living donor organ transplantation 
processes. The transplanting surgeon at the transplant program is 
responsible for ensuring the medical suitability of donor organs for 
transplantation into the intended recipient.
    (a) Standard: Organ receipt. After an organ arrives at a transplant 
program, prior to transplantation, the transplanting surgeon and another 
licensed health care professional must verify that the donor's blood 
type and other vital data are compatible with transplantation of the 
intended recipient.
    (b) Standard: Living donor transplantation. If a program performs 
living donor transplants, the transplanting surgeon and another licensed 
health care professional at the program must verify that the living 
donor's blood type and other vital data are compatible with 
transplantation of the intended recipient immediately before the removal 
of the donor organ(s) and, if applicable, prior to the removal of the 
recipient's organ(s).

[51 FR 22042, June 17, 1986, as amended at 77 FR 29076, May 16, 2012; 84 
FR 51822, Sept. 30, 2019]



Sec. 482.94  Condition of participation: Patient and living donor 
management.

    Transplant programs must have written patient management policies 
for the transplant and discharge phases of transplantation. If a 
transplant program performs living donor transplants, the program also 
must have written donor management policies for the donor evaluation, 
donation, and

[[Page 49]]

discharge phases of living organ donation.
    (a) Standard: Patient and living donor care. The transplant 
program's patient and donor management policies must ensure that:
    (1) Each transplant patient is under the care of a multidisciplinary 
patient care team coordinated by a physician throughout the transplant 
and discharge phases of transplantation; and
    (2) If a program performs living donor transplants, each living 
donor is under the care of a multidisciplinary patient care team 
coordinated by a physician throughout the donor evaluation, donation, 
and discharge phases of donation.
    (b) Standard: Waiting list management. Transplant programs must keep 
their waiting lists up to date on an ongoing basis, including:
    (1) Updating of waiting list patients' clinical information;
    (2) Removing patients from the program's waiting list if a patient 
receives a transplant or dies, or if there is any other reason the 
patient should no longer be on a program's waiting list; and
    (3) Notifying the OPTN no later than 24 hours after a patient's 
removal from the program's waiting list.
    (c) Standard: Patient records. Transplant programs must maintain up-
to-date and accurate patient management records for each patient who 
receives an evaluation for placement on a program's waiting list and who 
is admitted for organ transplantation.
    (1) For each patient who receives an evaluation for placement on a 
program's waiting list, the program must document in the patient's 
record that the patient (and in the case of a kidney patient, the 
patient's usual dialysis facility) has been informed of his or her 
transplant status, including notification of:
    (i) The patient's placement on the program's waiting list;
    (ii) The program's decision not to place the patient on its waiting 
list; or
    (iii) The program's inability to make a determination regarding the 
patient's placement on its waiting list because further clinical testing 
or documentation is needed.
    (2) If a patient on the waiting list is removed from the waiting 
list for any reason other than death or transplantation, the transplant 
program must document in the patient's record that the patient (and in 
the case of a kidney patient, the patient's usual dialysis facility) was 
notified no later than 10 days after the date the patient was removed 
from the waiting list.
    (3) In the case of patients admitted for organ transplants, 
transplant programs must maintain written records of:
    (i) Multidisciplinary patient care planning during the transplant 
period; and
    (ii) Multidisciplinary discharge planning for post-transplant care.
    (d) Standard: Social services. The transplant program must make 
social services available, furnished by qualified social workers, to 
transplant patients, living donors, and their families. A qualified 
social worker is an individual who meets licensing requirements in the 
State in which he or she practices; and
    (1) Completed a course of study with specialization in clinical 
practice and holds a master's degree from a graduate school of social 
work accredited by the Council on Social Work Education; or
    (2) Is working as a social worker in a transplant program as of the 
effective date of this final rule and has served for at least 2 years as 
a social worker, 1 year of which was in a transplantation program, and 
has established a consultative relationship with a social worker who is 
qualified under (d)(1) of this paragraph.
    (e) Standard: Nutritional services. Transplant programs must make 
nutritional assessments and diet counseling services, furnished by a 
qualified dietitian, available to all transplant patients and living 
donors. A qualified dietitian is an individual who meets practice 
requirements in the State in which he or she practices and is a 
registered dietitian with the Commission on Dietetic Registration.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]

[[Page 50]]



Sec. 482.96  Condition of participation: Quality assessment and 
performance improvement (QAPI).

    Transplant programs must develop, implement, and maintain a written, 
comprehensive, data-driven QAPI program designed to monitor and evaluate 
performance of all transplantation services, including services provided 
under contract or arrangement.
    (a) Standard: Components of a QAPI program. The transplant program's 
QAPI program must use objective measures to evaluate the center's 
performance with regard to transplantation activities and outcomes. 
Outcome measures may include, but are not limited to, patient and donor 
selection criteria, accuracy of the waiting list in accordance with the 
OPTN waiting list requirements, accuracy of donor and recipient 
matching, patient and donor management, techniques for organ recovery, 
consent practices, patient education, patient satisfaction, and patient 
rights. The transplant program must take actions that result in 
performance improvements and track performance to ensure that 
improvements are sustained.
    (b) Standard: Adverse events. A transplant program must establish 
and implement written policies to address and document adverse events 
that occur during any phase of an organ transplantation case.
    (1) The policies must address, at a minimum, the process for the 
identification, reporting, analysis, and prevention of adverse events.
    (2) The transplant program must conduct a thorough analysis of and 
document any adverse event and must utilize the analysis to effect 
changes in the transplant program's policies and practices to prevent 
repeat incidents.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]



Sec. 482.98  Condition of participation: Human resources.

    The transplant program must ensure that all individuals who provide 
services and/or supervise services at the program, including individuals 
furnishing services under contract or arrangement, are qualified to 
provide or supervise such services.
    (a) Standard: Director of a transplant program. The transplant 
program must be under the general supervision of a qualified transplant 
surgeon or a qualified physician-director. The director of a transplant 
program need not serve full-time and may also serve as a program's 
primary transplant surgeon or transplant physician in accordance with 
Sec. 482.98(b). The director is responsible for planning, organizing, 
conducting, and directing the transplant program and must devote 
sufficient time to carry out these responsibilities, which include but 
are not limited to the following:
    (1) Coordinating with the hospital in which the transplant program 
is located to ensure adequate training of nursing staff and clinical 
transplant coordinators in the care of transplant patients and living 
donors.
    (2) Ensuring that tissue typing and organ procurement services are 
available.
    (3) Ensuring that transplantation surgery is performed by, or under 
the direct supervision of, a qualified transplant surgeon in accordance 
with Sec. 482.98(b).
    (b) Standard: Transplant surgeon and physician. The transplant 
program must identify to the OPTN a primary transplant surgeon and a 
transplant physician with the appropriate training and experience to 
provide transplantation services, who are immediately available to 
provide transplantation services when an organ is offered for 
transplantation.
    (1) The transplant surgeon is responsible for providing surgical 
services related to transplantation.
    (2) The transplant physician is responsible for providing and 
coordinating transplantation care.
    (c) Standard: Clinical transplant coordinator. The transplant 
program must have a clinical transplant coordinator to ensure the 
continuity of care of patients and living donors during the pre-
transplant, transplant, and discharge phases of transplantation and the 
donor evaluation, donation, and discharge phases of donation. The 
clinical transplant coordinator must be a registered nurse or clinician 
licensed by the State in which the clinical transplant coordinator 
practices, who has

[[Page 51]]

experience and knowledge of transplantation and living donation issues. 
The clinical transplant coordinator's responsibilities must include, but 
are not limited to, the following:
    (1) Ensuring the coordination of the clinical aspects of transplant 
patient and living donor care; and
    (2) Acting as a liaison between a kidney transplant program and 
dialysis facilities, as applicable.
    (d) Standard: Independent living donor advocate or independent 
living donor advocate team. The transplant program that performs living 
donor transplantation must identify either an independent living donor 
advocate or an independent living donor advocate team to ensure 
protection of the rights of living donors and prospective living donors.
    (1) The independent living donor advocate or independent living 
donor advocate team must not be involved in transplantation activities 
on a routine basis.
    (2) The independent living donor advocate or independent living 
donor advocate team must demonstrate:
    (i) Knowledge of living organ donation, transplantation, medical 
ethics, and informed consent; and
    (ii) Understanding of the potential impact of family and other 
external pressures on the prospective living donor's decision whether to 
donate and the ability to discuss these issues with the donor.
    (3) The independent living donor advocate or independent living 
donor advocate team is responsible for:
    (i) Representing and advising the donor;
    (ii) Protecting and promoting the interests of the donor; and
    (iii) Respecting the donor's decision and ensuring that the donor's 
decision is informed and free from coercion.
    (e) Standard: Transplant team. The transplant program must identify 
a multidisciplinary transplant team and describe the responsibilities of 
each member of the team. The team must be composed of individuals with 
the appropriate qualifications, training, and experience in the relevant 
areas of medicine, nursing, nutrition, social services, transplant 
coordination, and pharmacology.
    (f) Standard: Resource commitment. The transplant program must 
demonstrate availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, blood banking, and patient education as related to the 
provision of transplantation services.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]



Sec. 482.100  Condition of participation: Organ procurement.

    The transplant program must ensure that the hospital in which it 
operates has a written agreement for the receipt of organs with an OPO 
designated by the Secretary that identifies specific responsibilities 
for the hospital and for the OPO with respect to organ recovery and 
organ allocation.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]



Sec. 482.102  Condition of participation: Patient and living donor
rights.

    In addition to meeting the condition of participation ``Patients 
rights'' requirements at Sec. 482.13, the transplant program must 
protect and promote each transplant patient's and living donor's rights.
    (a) Standard: Informed consent for transplant patients. Transplant 
programs must implement written transplant patient informed consent 
policies that inform each patient of:
    (1) The evaluation process;
    (2) The surgical procedure;
    (3) Alternative treatments;
    (4) Potential medical or psychosocial risks;
    (5) National and transplant program-specific outcomes, from the most 
recent SRTR program-specific report, including (but not limited to) the 
transplant program's observed and expected 1-year patient and graft 
survival, and national 1-year patient and graft survival;
    (6) Organ donor risk factors that could affect the success of the 
graft or the health of the patient, including, but not limited to, the 
donor's history, condition or age of the organs used, or the patient's 
potential risk of contracting the human immunodeficiency virus and other 
infectious diseases if

[[Page 52]]

the disease cannot be detected in an infected donor;
    (7) His or her right to refuse transplantation; and
    (8) The fact that if his or her transplant is not provided in a 
Medicare-approved transplant program it could affect the transplant 
recipient's ability to have his or her immunosuppressive drugs paid for 
under Medicare Part B.
    (b) Standard: Informed consent for living donors. Transplant 
programs must implement written living donor informed consent policies 
that inform the prospective living donor of all aspects of, and 
potential outcomes from, living donation. Transplant programs must 
ensure that the prospective living donor is fully informed about the 
following:
    (1) The fact that communication between the donor and the transplant 
program will remain confidential, in accordance with the requirements at 
45 CFR parts 160 and 164.
    (2) The evaluation process;
    (3) The surgical procedure, including post-operative treatment;
    (4) The availability of alternative treatments for the transplant 
recipient;
    (5) The potential medical or psychosocial risks to the donor;
    (6) The national and transplant program-specific outcomes for 
recipients, and the national and transplant-specific outcomes for living 
donors, as data are available;
    (7) The possibility that future health problems related to the 
donation may not be covered by the donor's insurance and that the 
donor's ability to obtain health, disability, or life insurance may be 
affected;
    (8) The donor's right to opt out of donation at any time during the 
donation process; and
    (9) The fact that if a transplant is not provided in a Medicare-
approved transplant program it could affect the transplant recipient's 
ability to have his or her immunosuppressive drugs paid for under 
Medicare Part B.
    (c) Standard: Notification to patients. Transplant programs must 
notify patients placed on the program's waiting list of information 
about the program that could impact the patient's ability to receive a 
transplant should an organ become available, and what procedures are in 
place to ensure the availability of a transplant team.
    (1) A transplant program served by a single transplant surgeon or 
physician must inform patients placed on the program's waiting list of:
    (i) The potential unavailability of the transplant surgeon or 
physician; and
    (ii) Whether the center has a mechanism to provide an alternate 
transplant surgeon or transplant physician.
    (2) At least 30 days before a program's Medicare approval is 
terminated, whether voluntarily or involuntarily, the center must:
    (i) Inform patients on the program's waiting list and provide 
assistance to waiting list patients who choose to transfer to the 
waiting list of another Medicare-approved transplant program without 
loss of time accrued on the waiting list; and
    (ii) Inform Medicare recipients on the program's waiting list that 
Medicare will no longer pay for transplants performed at the program 
after the effective date of the program's termination of approval.
    (3) As soon as possible prior to a transplant program's voluntary 
inactivation, the program must inform patients on the program's waiting 
list and, as directed by the Secretary, provide assistance to waiting 
list patients who choose to transfer to the waiting list of another 
Medicare-approved transplant program without loss of time accrued on the 
waiting list.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, 51824, Sept. 30, 
2019]



Sec. 482.104  Condition of participation: Additional requirements
for kidney transplant programs.

    (a) Standard: End stage renal disease (ESRD) services. Kidney 
transplant programs must directly furnish transplantation and other 
medical and surgical specialty services required for the care of ESRD 
patients. A kidney transplant program must have written policies and 
procedures for ongoing communications with dialysis patients' local 
dialysis facilities.

[[Page 53]]

    (b) Standard: Dialysis services. Kidney transplant programs must 
furnish inpatient dialysis services directly or under arrangement.
    (c) Standard: Participation in network activities. Kidney transplant 
programs must cooperate with the ESRD Network designated for their 
geographic area, in fulfilling the terms of the Network's current 
statement of work.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51824, Sept. 30, 2019]




PART 483_REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES--
Table of Contents



Subpart A [Reserved]

          Subpart B_Requirements for Long Term Care Facilities

Sec.
483.1 Basis and scope.
483.5 Definitions.
483.10 Resident rights.
483.12 Freedom from abuse, neglect, and exploitation.
483.15 Admission, transfer, and discharge rights.
483.20 Resident assessment.
483.21 Comprehensive person-centered care planning.
483.24 Quality of life.
483.25 Quality of care.
483.30 Physician services.
483.35 Nursing services.
483.40 Behavioral health services.
483.45 Pharmacy services.
483.50 Laboratory, radiology, and other diagnostic services.
483.55 Dental services.
483.60 Food and nutrition services.
483.65 Specialized rehabilitative services.
483.70 Administration.
483.73 Emergency preparedness.
483.75 Quality assurance and performance improvement.
483.80 Infection control.
483.85 Compliance and ethics program.
483.90 Physical environment.
483.95 Training requirements.

 Subpart C_Preadmission Screening and Annual Review of Mentally Ill and 
                      Mentally Retarded Individuals

483.100 Basis.
483.102 Applicability and definitions.
483.104 State plan requirement.
483.106 Basic rule.
483.108 Relationship of PASARR to other Medicaid processes.
483.110 Out-of-State arrangements.
483.112 Preadmission screening of applicants for admission to NFs.
483.114 Annual review of NF residents.
483.116 Residents and applicants determined to require NF level of 
          services.
483.118 Residents and applicants determined not to require NF level of 
          services.
483.120 Specialized services.
483.122 FFP for NF services.
483.124 FFP for specialized services.
483.126 Appropriate placement.
483.128 PASARR evaluation criteria.
483.130 PASARR determination criteria.
483.132 Evaluating the need for NF services and NF level of care 
          (PASARR/NF).
483.134 Evaluating whether an individual with mental illness requires 
          specialized services (PASARR/MI).
483.136 Evaluating whether an individual with intellectual disability 
          requires specialized services (PASARR/IID).
483.138 Maintenance of services and availability of FFP.

 Subpart D_Requirements That Must Be Met by States and State Agencies: 
    Nurse Aide Training and Competency Evaluation; and Paid Feeding 
                               Assistants

483.150 Statutory basis; Deemed meeting or waiver of requirements.
483.151 State review and approval of nurse aide training and competency 
          evaluation programs.
483.152 Requirements for approval of a nurse aide training and 
          competency evaluation program.
483.154 Nurse aide competency evaluation.
483.156 Registry of nurse aides.
483.158 FFP for nurse aide training and competency evaluation.
483.160 Requirements for training of paid feeding assistants.

 Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening 
           and Annual Resident Review (PASARR) Determinations

483.200 Statutory basis.
483.202 Definitions.
483.204 Provision of a hearing and appeal system.

[[Page 54]]

483.206 Transfers, discharges and relocations subject to appeal.

 Subpart F_Requirements That Must Be Met by States and State Agencies, 
                           Resident Assessment

483.315 Specification of resident assessment instrument.

    Subpart G_Condition of Participation for the Use of Restraint or 
  Seclusion in Psychiatric Residential Treatment Facilities Providing 
       Inpatient Psychiatric Services for Individuals Under Age 21

483.350 Basis and scope.
483.352 Definitions.
483.354 General requirements for psychiatric residential treatment 
          facilities.
483.356 Protection of residents.
483.358 Orders for the use of restraint or seclusion.
483.360 Consultation with treatment team physician.
483.362 Monitoring of the resident in and immediately after restraint.
483.364 Monitoring of the resident in and immediately after seclusion.
483.366 Notification of parent(s) or legal guardian(s).
483.368 Application of time out.
483.370 Postintervention debriefings.
483.372 Medical treatment for injuries resulting from an emergency 
          safety intervention.
483.374 Facility reporting.
483.376 Education and training.

Subpart H [Reserved]

 Subpart I_Conditions of Participation for Intermediate Care Facilities 
             for Individuals with Intellectual Disabilities

483.400 Basis and purpose.
483.405 Relationship to other HHS regulations.
483.410 Condition of participation: Governing body and management.
483.420 Condition of participation: Client protections.
483.430 Condition of participation: Facility staffing.
483.440 Condition of participation: Active treatment services.
483.450 Condition of participation: Client behavior and facility 
          practices.
483.460 Condition of participation: Health care services.
483.470 Condition of participation: Physical environment.
483.475 Condition of participation: Emergency preparedness.
483.480 Condition of participation: Dietetic services.

    Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.

Subpart A [Reserved]





          Subpart B_Requirements for Long Term Care Facilities

    Source: 54 FR 5359, Feb. 2, 1989, unless otherwise noted.



Sec. 483.1  Basis and scope.

    (a) Statutory basis. (1) Sections 1819(a), (b), (c), (d), and (f) of 
the Act provide that--
    (i) Skilled nursing facilities participating in Medicare must meet 
certain specified requirements; and
    (ii) The Secretary may impose additional requirements (see section 
1819(d)(4)(B)) if they are necessary for the health and safety of 
individuals to whom services are furnished in the facilities.
    (2) Section 1861(l) of the Act requires the facility to have in 
effect a transfer agreement with a hospital.
    (3) Sections 1919(a), (b), (c), (d), and (f) of the Act provide that 
nursing facilities participating in Medicaid must meet certain specific 
requirements.
    (4) Sections 1128I(b) and (c) require that--
    (i) Skilled nursing facilities or nursing facility have in operation 
a compliance and ethics program that is effective in preventing and 
detecting criminal, civil, and administrative violations.
    (ii) The Secretary establish and implement a quality assurance and 
performance improvement program for facilities, including multi-unit 
chains of facilities.
    (5) Section 1150B establishes requirements for reporting to law 
enforcement crimes occurring in federally funded LTC facilities.
    (b) Scope. The provisions of this part contain the requirements that 
an institution must meet in order to qualify to participate as a Skilled 
Nursing Facility in the Medicare program, and as a

[[Page 55]]

nursing facility in the Medicaid program. They serve as the basis for 
survey activities for the purpose of determining whether a facility 
meets the requirements for participation in Medicare and Medicaid.

[56 FR 48867, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992; 
60 FR 50443, Sept. 29, 1995; 81 FR 68848, Oct. 4, 2016]



Sec. 483.5  Definitions.

    As used in this subpart, the following definitions apply:
    Abuse. Abuse is the willful infliction of injury, unreasonable 
confinement, intimidation, or punishment with resulting physical harm, 
pain or mental anguish. Abuse also includes the deprivation by an 
individual, including a caretaker, of goods or services that are 
necessary to attain or maintain physical, mental, and psychosocial well-
being. Instances of abuse of all residents, irrespective of any mental 
or physical condition, cause physical harm, pain or mental anguish. It 
includes verbal abuse, sexual abuse, physical abuse, and mental abuse 
including abuse facilitated or enabled through the use of technology. 
Willful, as used in this definition of abuse, means the individual must 
have acted deliberately, not that the individual must have intended to 
inflict injury or harm.
    Adverse event. An adverse event is an untoward, undesirable, and 
usually unanticipated event that causes death or serious injury, or the 
risk thereof.
    Common area. Common areas are areas in the facility where residents 
may gather together with other residents, visitors, and staff or engage 
in individual pursuits, apart from their residential rooms. This 
includes but is not limited to living rooms, dining rooms, activity 
rooms, outdoor areas, and meeting rooms where residents are located on a 
regular basis.
    Composite distinct part--(1) Definition. A composite distinct part 
is a distinct part consisting of two or more noncontiguous components 
that are not located within the same campus, as defined in Sec. 
413.65(a)(2) of this chapter.
    (2) Requirements. In addition to meeting the requirements of 
specified in the definition of ``distinct part'' of this section, a 
composite distinct part must meet all of the following requirements:
    (i) A SNF or NF that is a composite of more than one location will 
be treated as a single distinct part of the institution of which it is a 
distinct part. As such, the composite distinct part will have only one 
provider agreement and only one provider number.
    (ii) If two or more institutions (each with a distinct part SNF or 
NF) undergo a change of ownership, CMS must approve the existing SNFs or 
NFs as meeting the requirements before they are considered a composite 
distinct part of a single institution. In making such a determination, 
CMS considers whether its approval or disapproval of a composite 
distinct part promotes the effective and efficient use of public monies 
without sacrificing the quality of care.
    (iii) If there is a change of ownership of a composite distinct part 
SNF or NF, the assignment of the provider agreement to the new owner 
will apply to all of the approved locations that comprise the composite 
distinct part SNF or NF.
    (iv) To ensure quality of care and quality of life for all 
residents, the various components of a composite distinct part must meet 
all of the requirements for participation independently in each 
location.
    (v) Use of composite distinct parts to segregate residents by 
payment source or on a basis other than care needs is prohibited.
    Distinct part--(1) Definition. A distinct part SNF or NF is 
physically distinguishable from the larger institution or institutional 
complex that houses it, meets the requirements of this paragraph and of 
paragraph (2) of this definition, and meets the applicable statutory 
requirements for SNFs or NFs in sections 1819 or 1919 of the Act, 
respectively. A distinct part SNF or NF may comprise one or more 
buildings or designated parts of buildings (that is, wings, wards, or 
floors) that are: In the same physical area immediately adjacent to the 
institution's main buildings; other areas and structures that are not 
strictly contiguous with the main buildings but are located within close 
proximity to the main buildings;

[[Page 56]]

and any other areas that CMS determines on an individual basis, to be 
part of the institution's campus. A distinct part must include all of 
the beds within the designated area, and cannot consist of a random 
collection of individual rooms or beds that are scattered throughout the 
physical plant. The term ``distinct part'' also includes a composite 
distinct part that meets the additional requirements specified in the 
definition of ``composite distinct part'' of this section.
    (2) Requirements. In addition to meeting the participation 
requirements for long-term care facilities set forth elsewhere in this 
subpart, a distinct part SNF or NF must meet all of the following 
requirements:
    (i) The SNF or NF must be operated under common ownership and 
control (that is, common governance) by the institution of which it is a 
distinct part, as evidenced by the following:
    (A) The SNF or NF is wholly owned by the institution of which it is 
a distinct part.
    (B) The SNF or NF is subject to the by-laws and operating decisions 
of a common governing body.
    (C) The institution of which the SNF or NF is a distinct part has 
final responsibility for the distinct part's administrative decisions 
and personnel policies, and final approval for the distinct part's 
personnel actions.
    (D) The SNF or NF functions as an integral and subordinate part of 
the institution of which it is a distinct part, with significant common 
resource usage of buildings, equipment, personnel, and services.
    (ii) The administrator of the SNF or NF reports to and is directly 
accountable to the management of the institution of which the SNF or NF 
is a distinct part.
    (iii) The SNF or NF must have a designated medical director who is 
responsible for implementing care policies and coordinating medical 
care, and who is directly accountable to the management of the 
institution of which it is a distinct part.
    (iv) The SNF or NF is financially integrated with the institution of 
which it is a distinct part, as evidenced by the sharing of income and 
expenses with that institution, and the reporting of its costs on that 
institution's cost report.
    (v) A single institution can have a maximum of only one distinct 
part SNF and one distinct part NF.
    (vi) (A) An institution cannot designate a distinct part SNF or NF, 
but instead must submit a written request with documentation that 
demonstrates it meets the criteria set forth above to CMS to determine 
if it may be considered a distinct part.
    (B) The effective date of approval of a distinct part is the date 
that CMS determines all requirements (including enrollment with the 
fiscal intermediary (FI)) are met for approval, and cannot be made 
retroactive.
    (C) The institution must request approval from CMS for all proposed 
changes in the number of beds in the approved distinct part.
    Exploitation. Exploitation means taking advantage of a resident for 
personal gain through the use of manipulation, intimidation, threats, or 
coercion.
    Facility. For purposes of this subpart, facility means a skilled 
nursing facility (SNF) that meets the requirements of sections 1819(a), 
(b), (c), and (d) of the Act, or a nursing facility (NF) that meets the 
requirements of sections 1919(a), (b), (c), and (d) of the Act. 
``Facility'' may include a distinct part of an institution (as defined 
in paragraph (b) of this section and specified in Sec. 440.40 and Sec. 
440.155 of this chapter), but does not include an institution for 
individuals with intellectual disabilities or persons with related 
conditions described in Sec. 440.150 of this chapter. For Medicare and 
Medicaid purposes (including eligibility, coverage, certification, and 
payment), the ``facility'' is always the entity that participates in the 
program, whether that entity is comprised of all of, or a distinct part 
of, a larger institution. For Medicare, an SNF (see section 1819(a)(1) 
of the Act), and for Medicaid, an NF (see section 1919(a)(1) of the Act) 
may not be an institution for mental diseases as defined in Sec. 
435.1010 of this chapter.
    Fully sprinklered. A fully sprinklered long term care facility is 
one that has all areas sprinklered in accordance with National Fire 
Protection Association 13 ``Standard for the Installation of Sprinkler 
Systems'' without the use

[[Page 57]]

of waivers or the Fire Safety Evaluation System.
    Licensed health professional. A licensed health professional is a 
physician; physician assistant; nurse practitioner; physical, speech, or 
occupational therapist; physical or occupational therapy assistant; 
registered professional nurse; licensed practical nurse; or licensed or 
certified social worker; or registered respiratory therapist or 
certified respiratory therapy technician.
    Major modification means the modification of more than 50 percent, 
or more than 4,500 square feet, of the smoke compartment.
    Misappropriation of resident property means the deliberate 
misplacement, exploitation, or wrongful, temporary, or permanent use of 
a resident's belongings or money without the resident's consent.
    Mistreatment means inappropriate treatment or exploitation of a 
resident.
    Neglect is the failure of the facility, its employees or service 
providers to provide goods and services to a resident that are necessary 
to avoid physical harm, pain, mental anguish, or emotional distress.
    Nurse aide. A nurse aide is any individual providing nursing or 
nursing-related services to residents in a facility. This term may also 
include an individual who provides these services through an agency or 
under a contract with the facility, but is not a licensed health 
professional, a registered dietitian, or someone who volunteers to 
provide such services without pay. Nurse aides do not include those 
individuals who furnish services to residents only as paid feeding 
assistants as defined in Sec. 488.301 of this chapter.
    Person-centered care. For purposes of this subpart, person-centered 
care means to focus on the resident as the locus of control and support 
the resident in making their own choices and having control over their 
daily lives.
    Resident representative. For purposes of this subpart, the term 
resident representative means any of the following:
    (1) An individual chosen by the resident to act on behalf of the 
resident in order to support the resident in decision-making; access 
medical, social or other personal information of the resident; manage 
financial matters; or receive notifications;
    (2) A person authorized by State or Federal law (including but not 
limited to agents under power of attorney, representative payees, and 
other fiduciaries) to act on behalf of the resident in order to support 
the resident in decision-making; access medical, social or other 
personal information of the resident; manage financial matters; or 
receive notifications;
    (3) Legal representative, as used in section 712 of the Older 
Americans Act; or.
    (4) The court-appointed guardian or conservator of a resident.
    (5) Nothing in this rule is intended to expand the scope of 
authority of any resident representative beyond that authority 
specifically authorized by the resident, State or Federal law, or a 
court of competent jurisdiction.
    Sexual abuse is non-consensual sexual contact of any type with a 
resident.
    Transfer and discharge includes movement of a resident to a bed 
outside of the certified facility whether that bed is in the same 
physical plant or not. Transfer and discharge does not refer to movement 
of a resident to a bed within the same certified facility.

[68 FR 46071, Aug. 4, 2003, as amended at 71 FR 39229, July 12, 2006; 71 
FR 55340, Sept. 22, 2006; 79 FR 27155, May 12, 2014; 81 FR 68848, Oct. 
4, 2016; 82 FR 32259, July 13, 2017]



Sec. 483.10  Resident rights.

    (a) Residents rights. The resident has a right to a dignified 
existence, self-determination, and communication with and access to 
persons and services inside and outside the facility, including those 
specified in this section.
    (1) A facility must treat each resident with respect and dignity and 
care for each resident in a manner and in an environment that promotes 
maintenance or enhancement of his or her quality of life, recognizing 
each resident's individuality. The facility must protect and promote the 
rights of the resident.
    (2) The facility must provide equal access to quality care 
regardless of diagnosis, severity of condition, or payment source. A 
facility must establish and maintain identical policies and practices 
regarding transfer, discharge,

[[Page 58]]

and the provision of services under the State plan for all residents 
regardless of payment source.
    (b) Exercise of rights. The resident has the right to exercise his 
or her rights as a resident of the facility and as a citizen or resident 
of the United States.
    (1) The facility must ensure that the resident can exercise his or 
her rights without interference, coercion, discrimination, or reprisal 
from the facility
    (2) The resident has the right to be free of interference, coercion, 
discrimination, and reprisal from the facility in exercising his or her 
rights and to be supported by the facility in the exercise of his or her 
rights as required under this subpart.
    (3) In the case of a resident who has not been adjudged incompetent 
by the state court, the resident has the right to designate a 
representative, in accordance with State law and any legal surrogate so 
designated may exercise the resident's rights to the extent provided by 
state law. The same-sex spouse of a resident must be afforded treatment 
equal to that afforded to an opposite-sex spouse if the marriage was 
valid in the jurisdiction in which it was celebrated.
    (i) The resident representative has the right to exercise the 
resident's rights to the extent those rights are delegated to the 
resident representative.
    (ii) The resident retains the right to exercise those rights not 
delegated to a resident representative, including the right to revoke a 
delegation of rights, except as limited by State law.
    (4) The facility must treat the decisions of a resident 
representative as the decisions of the resident to the extent required 
by the court or delegated by the resident, in accordance with applicable 
law.
    (5) The facility shall not extend the resident representative the 
right to make decisions on behalf of the resident beyond the extent 
required by the court or delegated by the resident, in accordance with 
applicable law.
    (6) If the facility has reason to believe that a resident 
representative is making decisions or taking actions that are not in the 
best interests of a resident, the facility shall report such concerns in 
the manner required under State law.
    (7) In the case of a resident adjudged incompetent under the laws of 
a State by a court of competent jurisdiction, the rights of the resident 
devolve to and are exercised by the resident representative appointed 
under State law to act on the resident's behalf. The court-appointed 
resident representative exercises the resident's rights to the extent 
judged necessary by a court of competent jurisdiction, in accordance 
with State law
    (i) In the case of a resident representative whose decision-making 
authority is limited by State law or court appointment, the resident 
retains the right to make those decision outside the representative's 
authority.
    (ii) The resident's wishes and preferences must be considered in the 
exercise of rights by the representative.
    (iii) To the extent practicable, the resident must be provided with 
opportunities to participate in the care planning process.
    (c) Planning and implementing care. The resident has the right to be 
informed of, and participate in, his or her treatment, including:
    (1) The right to be fully informed in language that he or she can 
understand of his or her total health status, including but not limited 
to, his or her medical condition.
    (2) The right to participate in the development and implementation 
of his or her person-centered plan of care, including but not limited 
to:
    (i) The right to participate in the planning process, including the 
right to identify individuals or roles to be included in the planning 
process, the right to request meetings and the right to request 
revisions to the person-centered plan of care.
    (ii) The right to participate in establishing the expected goals and 
outcomes of care, the type, amount, frequency, and duration of care, and 
any other factors related to the effectiveness of the plan of care.
    (iii) The right to be informed, in advance, of changes to the plan 
of care.
    (iv) The right to receive the services and/or items included in the 
plan of care.

[[Page 59]]

    (v) The right to see the care plan, including the right to sign 
after significant changes to the plan of care.
    (3) The facility shall inform the resident of the right to 
participate in his or her treatment and shall support the resident in 
this right. The planning process must--
    (i) Facilitate the inclusion of the resident and/or resident 
representative.
    (ii) Include an assessment of the resident's strengths and needs.
    (iii) Incorporate the resident's personal and cultural preferences 
in developing goals of care.
    (4) The right to be informed, in advance, of the care to be 
furnished and the type of care giver or professional that will furnish 
care.
    (5) The right to be informed in advance, by the physician or other 
practitioner or professional, of the risks and benefits of proposed 
care, of treatment and treatment alternatives or treatment options and 
to choose the alternative or option he or she prefers.
    (6) The right to request, refuse, and/or discontinue treatment, to 
participate in or refuse to participate in experimental research, and to 
formulate an advance directive.
    (7) The right to self-administer medications if the 
interdisciplinary team, as defined by Sec. 483.21(b)(2)(ii), has 
determined that this practice is clinically appropriate.
    (8) Nothing in this paragraph should be construed as the right of 
the resident to receive the provision of medical treatment or medical 
services deemed medically unnecessary or inappropriate.
    (d) Choice of attending physician. The resident has the right to 
choose his or her attending physician.
    (1) The physician must be licensed to practice, and
    (2) If the physician chosen by the resident refuses to or does not 
meet requirements specified in this part, the facility may seek 
alternate physician participation as specified in paragraphs (d)(4) and 
(5) of this section to assure provision of appropriate and adequate care 
and treatment.
    (3) The facility must ensure that each resident remains informed of 
the name, specialty, and way of contacting the physician and other 
primary care professionals responsible for his or her care.
    (4) The facility must inform the resident if the facility determines 
that the physician chosen by the resident is unable or unwilling to meet 
requirements specified in this part and the facility seeks alternate 
physician participation to assure provision of appropriate and adequate 
care and treatment. The facility must discuss the alternative physician 
participation with the resident and honor the resident's preferences, if 
any, among options.
    (5) If the resident subsequently selects another attending physician 
who meets the requirements specified in this part, the facility must 
honor that choice.
    (e) Respect and dignity. The resident has a right to be treated with 
respect and dignity, including:
    (1) The right to be free from any physical or chemical restraints 
imposed for purposes of discipline or convenience, and not required to 
treat the resident's medical symptoms, consistent with Sec. 
483.12(a)(2).
    (2) The right to retain and use personal possessions, including 
furnishings, and clothing, as space permits, unless to do so would 
infringe upon the rights or health and safety of other residents.
    (3) The right to reside and receive services in the facility with 
reasonable accommodation of resident needs and preferences except when 
to do so would endanger the health or safety of the resident or other 
residents.
    (4) The right to share a room with his or her spouse when married 
residents live in the same facility and both spouses consent to the 
arrangement.
    (5) The right to share a room with his or her roommate of choice 
when practicable, when both residents live in the same facility and both 
residents consent to the arrangement.
    (6) The right to receive written notice, including the reason for 
the change, before the resident's room or roommate in the facility is 
changed.
    (7) The right to refuse to transfer to another room in the facility, 
if the purpose of the transfer is:

[[Page 60]]

    (i) To relocate a resident of a SNF from the distinct part of the 
institution that is a SNF to a part of the institution that is not a 
SNF, or
    (ii) to relocate a resident of a NF from the distinct part of the 
institution that is a NF to a distinct part of the institution that is a 
SNF.
    (iii) solely for the convenience of staff.
    (8) A resident's exercise of the right to refuse transfer does not 
affect the resident's eligibility or entitlement to Medicare or Medicaid 
benefits.
    (f) Self-determination. The resident has the right to and the 
facility must promote and facilitate resident self-determination through 
support of resident choice, including but not limited to the rights 
specified in paragraphs (f)(1) through (11) of this section.
    (1) The resident has a right to choose activities, schedules 
(including sleeping and waking times), health care and providers of 
health care services consistent with his or her interests, assessments, 
plan of care and other applicable provisions of this part.
    (2) The resident has the right to make choices about aspects of his 
or her life in the facility that are significant to the resident.
    (3) The resident has a right to interact with members of the 
community and participate in community activities both inside and 
outside the facility.
    (4) The resident has a right to receive visitors of his or her 
choosing at the time of his or her choosing, subject to the resident's 
right to deny visitation when applicable, and in a manner that does not 
impose on the rights of another resident.
    (i) The facility must provide immediate access to any resident by--
    (A) Any representative of the Secretary,
    (B) Any representative of the State,
    (C) Any representative of the Office of the State long term care 
ombudsman, (established under section 712 of the Older Americans Act of 
1965, as amended 2016 (42 U.S.C. 3001 et seq.),
    (D) The resident's individual physician,
    (E) Any representative of the protection and advocacy systems, as 
designated by the state, and as established under the Developmental 
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 
et seq.),
    (F) Any representative of the agency responsible for the protection 
and advocacy system for individuals with a mental disorder (established 
under the Protection and Advocacy for Mentally Ill Individuals Act of 
2000 (42 U.S.C. 10801 et seq.), and
    (G) The resident representative.
    (ii) The facility must provide immediate access to a resident by 
immediate family and other relatives of the resident, subject to the 
resident's right to deny or withdraw consent at any time;
    (iii) The facility must provide immediate access to a resident by 
others who are visiting with the consent of the resident, subject to 
reasonable clinical and safety restrictions and the resident's right to 
deny or withdraw consent at any time;
    (iv) The facility must provide reasonable access to a resident by 
any entity or individual that provides health, social, legal, or other 
services to the resident, subject to the resident's right to deny or 
withdraw consent at any time; and
    (v) The facility must have written policies and procedures regarding 
the visitation rights of residents, including those setting forth any 
clinically necessary or reasonable restriction or limitation or safety 
restriction or limitation, when such limitations may apply consistent 
with the requirements of this subpart, that the facility may need to 
place on such rights and the reasons for the clinical or safety 
restriction or limitation.
    (vi) A facility must meet the following requirements:
    (A) Inform each resident (or resident representative, where 
appropriate) of his or her visitation rights and related facility policy 
and procedures, including any clinical or safety restriction or 
limitation on such rights, consistent with the requirements of this 
subpart, the reasons for the restriction or limitation, and to whom the 
restrictions apply, when he or she is informed of his or her other 
rights under this section.
    (B) Inform each resident of the right, subject to his or her 
consent, to receive the visitors whom he or she designates, including, 
but not limited to, a spouse

[[Page 61]]

(including a same-sex spouse), a domestic partner (including a same-sex 
domestic partner), another family member, or a friend, and his or her 
right to withdraw or deny such consent at any time.
    (C) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, gender 
identity, sexual orientation, or disability.
    (D) Ensure that all visitors enjoy full and equal visitation 
privileges consistent with resident preferences.
    (5) The resident has a right to organize and participate in resident 
groups in the facility.
    (i) The facility must provide a resident or family group, if one 
exists, with private space; and take reasonable steps, with the approval 
of the group, to make residents and family members aware of upcoming 
meetings in a timely manner.
    (ii) Staff, visitors, or other guests may attend resident group or 
family group meetings only at the respective group's invitation.
    (iii) The facility must provide a designated staff person who is 
approved by the resident or family group and the facility and who is 
responsible for providing assistance and responding to written requests 
that result from group meetings.
    (iv) The facility must consider the views of a resident or family 
group and act promptly upon the grievances and recommendations of such 
groups concerning issues of resident care and life in the facility.
    (A) The facility must be able to demonstrate their response and 
rationale for such response.
    (B) This should not be construed to mean that the facility must 
implement as recommended every request of the resident or family group.
    (6) The resident has a right to participate in family groups.
    (7) The resident has a right to have family member(s) or other 
resident representative(s) meet in the facility with the families or 
resident representative(s) of other residents in the facility.
    (8) The resident has a right to participate in other activities, 
including social, religious, and community activities that do not 
interfere with the rights of other residents in the facility.
    (9) The resident has a right to choose to or refuse to perform 
services for the facility and the facility must not require a resident 
to perform services for the facility. The resident may perform services 
for the facility, if he or she chooses, when--
    (i) The facility has documented the resident's need or desire for 
work in the plan of care;
    (ii) The plan specifies the nature of the services performed and 
whether the services are voluntary or paid;
    (iii) Compensation for paid services is at or above prevailing 
rates; and
    (iv) The resident agrees to the work arrangement described in the 
plan of care.
    (10) The resident has a right to manage his or her financial 
affairs. This includes the right to know, in advance, what charges a 
facility may impose against a resident's personal funds.
    (i) The facility must not require residents to deposit their 
personal funds with the facility. If a resident chooses to deposit 
personal funds with the facility, upon written authorization of a 
resident, the facility must act as a fiduciary of the resident's funds 
and hold, safeguard, manage, and account for the personal funds of the 
resident deposited with the facility, as specified in this section.
    (ii) Deposit of funds. (A) In general: Except as set out in 
paragraph (f)(10)(ii)(B) of this section, the facility must deposit any 
residents' personal funds in excess of $100 in an interest bearing 
account (or accounts) that is separate from any of the facility's 
operating accounts, and that credits all interest earned on resident's 
funds to that account. (In pooled accounts, there must be a separate 
accounting for each resident's share.) The facility must maintain a 
resident's personal funds that do not exceed $100 in a non-interest 
bearing account, interest-bearing account, or petty cash fund.
    (B) Residents whose care is funded by Medicaid: The facility must 
deposit the residents' personal funds in excess of $50 in an interest 
bearing account (or accounts) that is separate from any of the 
facility's operating accounts, and

[[Page 62]]

that credits all interest earned on resident's funds to that account. 
(In pooled accounts, there must be a separate accounting for each 
resident's share.) The facility must maintain personal funds that do not 
exceed $50 in a non-interest bearing account, interest-bearing account, 
or petty cash fund.
    (iii) Accounting and records. (A) The facility must establish and 
maintain a system that assures a full and complete and separate 
accounting, according to generally accepted accounting principles, of 
each resident's personal funds entrusted to the facility on the 
resident's behalf.
    (B) The system must preclude any commingling of resident funds with 
facility funds or with the funds of any person other than another 
resident.
    (C) The individual financial record must be available to the 
resident through quarterly statements and upon request.
    (iv) Notice of certain balances. The facility must notify each 
resident that receives Medicaid benefits--
    (A) When the amount in the resident's account reaches $200 less than 
the SSI resource limit for one person, specified in section 
1611(a)(3)(B) of the Act; and
    (B) That, if the amount in the account, in addition to the value of 
the resident's other nonexempt resources, reaches the SSI resource limit 
for one person, the resident may lose eligibility for Medicaid or SSI.
    (v) Conveyance upon discharge, eviction, or death. Upon the 
discharge, eviction, or death of a resident with a personal fund 
deposited with the facility, the facility must convey within 30 days the 
resident's funds, and a final accounting of those funds, to the 
resident, or in the case of death, the individual or probate 
jurisdiction administering the resident's estate, in accordance with 
State law.
    (vi) Assurance of financial security. The facility must purchase a 
surety bond, or otherwise provide assurance satisfactory to the 
Secretary, to assure the security of all personal funds of residents 
deposited with the facility.
    (11) The facility must not impose a charge against the personal 
funds of a resident for any item or service for which payment is made 
under Medicaid or Medicare (except for applicable deductible and 
coinsurance amounts). The facility may charge the resident for requested 
services that are more expensive than or in excess of covered services 
in accordance with Sec. 489.32 of this chapter. (This does not affect 
the prohibition on facility charges for items and services for which 
Medicaid has paid. See Sec. 447.15 of this chapter, which limits 
participation in the Medicaid program to providers who accept, as 
payment in full, Medicaid payment plus any deductible, coinsurance, or 
copayment required by the plan to be paid by the individual.)
    (i) Services included in Medicare or Medicaid payment. During the 
course of a covered Medicare or Medicaid stay, facilities must not 
charge a resident for the following categories of items and services:
    (A) Nursing services as required at Sec. 483.35.
    (B) Food and Nutrition services as required at Sec. 483.60.
    (C) An activities program as required at Sec. 483.24(c).
    (D) Room/bed maintenance services.
    (E) Routine personal hygiene items and services as required to meet 
the needs of residents, including, but not limited to, hair hygiene 
supplies, comb, brush, bath soap, disinfecting soaps or specialized 
cleansing agents when indicated to treat special skin problems or to 
fight infection, razor, shaving cream, toothbrush, toothpaste, denture 
adhesive, denture cleaner, dental floss, moisturizing lotion, tissues, 
cotton balls, cotton swabs, deodorant, incontinence care and supplies, 
sanitary napkins and related supplies, towels, washcloths, hospital 
gowns, over the counter drugs, hair and nail hygiene services, bathing 
assistance, and basic personal laundry.
    (F) Medically-related social services as required at Sec. 
483.40(d).
    (G) Hospice services elected by the resident and paid for under the 
Medicare Hospice Benefit or paid for by Medicaid under a state plan.
    (ii) Items and services that may be charged to residents' funds. 
Paragraphs (f)(11)(ii)(A) through (L) of this section are general 
categories and examples of items and services that the facility may 
charge to residents' funds if they

[[Page 63]]

are requested by a resident, if they are not required to achieve the 
goals stated in the resident's care plan, if the facility informs the 
resident that there will be a charge, and if payment is not made by 
Medicare or Medicaid:
    (A) Telephone, including a cellular phone.
    (B) Television/radio, personal computer or other electronic device 
for personal use.
    (C) Personal comfort items, including smoking materials, notions and 
novelties, and confections.
    (D) Cosmetic and grooming items and services in excess of those for 
which payment is made under Medicaid or Medicare.
    (E) Personal clothing.
    (F) Personal reading matter.
    (G) Gifts purchased on behalf of a resident.
    (H) Flowers and plants.
    (I) Cost to participate in social events and entertainment outside 
the scope of the activities program, provided under Sec. 483.24(c).
    (J) Non-covered special care services such as privately hired nurses 
or aides.
    (K) Private room, except when therapeutically required (for example, 
isolation for infection control).
    (L) Except as provided in (e)(11)(ii)(L)(1) and (2) of this section, 
specially prepared or alternative food requested instead of the food and 
meals generally prepared by the facility, as required by Sec. 483.60.
    (1) The facility may not charge for special foods and meals, 
including medically prescribed dietary supplements, ordered by the 
resident's physician, physician assistant, nurse practitioner, or 
clinical nurse specialist, as these are included in accordance with 
Sec. 483.60.
    (2) In accordance with Sec. 483.60(c) through (f), when preparing 
foods and meals, a facility must take into consideration residents' 
needs and preferences and the overall cultural and religious make-up of 
the facility's population.
    (iii) Requests for items and services. (A) The facility can only 
charge a resident for any non-covered item or service if such item or 
service is specifically requested by the resident.
    (B) The facility must not require a resident to request any item or 
service as a condition of admission or continued stay.
    (C) The facility must inform, orally and in writing, the resident 
requesting an item or service for which a charge will be made that there 
will be a charge for the item or service and what the charge will be.
    (g) Information and communication. (1) The resident has the right to 
be informed of his or her rights and of all rules and regulations 
governing resident conduct and responsibilities during his or her stay 
in the facility.
    (2) The resident has the right to access personal and medical 
records pertaining to him or herself.
    (i) The facility must provide the resident with access to personal 
and medical records pertaining to him or herself, upon an oral or 
written request, in the form and format requested by the individual, if 
it is readily producible in such form and format (including in an 
electronic form or format when such records are maintained 
electronically); or, if not, in a readable hard copy form or such other 
form and format as agreed to by the facility and the individual, within 
24 hours (excluding weekends and holidays); and
    (ii) The facility must allow the resident to obtain a copy of the 
records or any portions thereof (including in an electronic form or 
format when such records are maintained electronically) upon request and 
2 working days advance notice to the facility. The facility may impose a 
reasonable, cost-based fee on the provision of copies, provided that the 
fee includes only the cost of:
    (A) Labor for copying the records requested by the individual, 
whether in paper or electronic form;
    (B) Supplies for creating the paper copy or electronic media if the 
individual requests that the electronic copy be provided on portable 
media; and
    (C) Postage, when the individual has requested the copy be mailed.
    (3) With the exception of information described in paragraphs (g)(2) 
and (g)(11) of this section, the facility must ensure that information 
is provided to each resident in a form and manner the

[[Page 64]]

resident can access and understand, including in an alternative format 
or in a language that the resident can understand. Summaries that 
translate information described in paragraph (g)(2) of this section may 
be made available to the patient at their request and expense in 
accordance with applicable law.
    (4) The resident has the right to receive notices orally (meaning 
spoken) and in writing (including Braille) in a format and a language he 
or she understands, including;
    (i) Required notices as specified in this section. The facility must 
furnish to each resident a written description of legal rights which 
includes--
    (A) A description of the manner of protecting personal funds, under 
paragraph (f)(10) of this section;
    (B) A description of the requirements and procedures for 
establishing eligibility for Medicaid, including the right to request an 
assessment of resources under section 1924(c) of the Social Security 
Act.
    (C) A list of names, addresses (mailing and email), and telephone 
numbers of all pertinent State regulatory and informational agencies, 
resident advocacy groups such as the State Survey Agency, the State 
licensure office, the State Long-Term Care Ombudsman program, the 
protection and advocacy agency, adult protective services where state 
law provides for jurisdiction in long-term care facilities, the local 
contact agency for information about returning to the community and the 
Medicaid Fraud Control Unit; and
    (D) A statement that the resident may file a complaint with the 
State Survey Agency concerning any suspected violation of state or 
federal nursing facility regulations, including but not limited to 
resident abuse, neglect, exploitation, misappropriation of resident 
property in the facility, non-compliance with the advance directives 
requirements and requests for information regarding returning to the 
community.
    (ii) Information and contact information for State and local 
advocacy organizations, including but not limited to the State Survey 
Agency, the State Long-Term Care Ombudsman program (established under 
section 712 of the Older Americans Act of 1965, as amended 2016 (42 
U.S.C. 3001 et seq.) and the protection and advocacy system (as 
designated by the state, and as established under the Developmental 
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 
et seq.);
    (iii) Information regarding Medicare and Medicaid eligibility and 
coverage;
    (iv) Contact information for the Aging and Disability Resource 
Center (established under Section 202(a)(20)(B)(iii) of the Older 
Americans Act); or other No Wrong Door Program
    (v) Contact information for the Medicaid Fraud Control Unit; and
    (vi) Information and contact information for filing grievances or 
complaints concerning any suspected violation of state or federal 
nursing facility regulations, including but not limited to resident 
abuse, neglect, exploitation, misappropriation of resident property in 
the facility, non-compliance with the advance directives requirements 
and requests for information regarding returning to the community.
    (5) The facility must post, in a form and manner accessible and 
understandable to residents, and resident representatives:
    (i) A list of names, addresses (mailing and email), and telephone 
numbers of all pertinent State agencies and advocacy groups, such as the 
State Survey Agency, the State licensure office, adult protective 
services where state law provides for jurisdiction in long-term care 
facilities, the Office of the State Long-Term Care Ombudsman program, 
the protection and advocacy network, home and community based service 
programs, and the Medicaid Fraud Control Unit; and
    (ii) A statement that the resident may file a complaint with the 
State Survey Agency concerning any suspected violation of state or 
federal nursing facility regulations, including but not limited to 
resident abuse, neglect, exploitation, misappropriation of resident 
property in the facility, non-compliance with the advance directives 
requirements (42 CFR part 489 subpart I) and requests for information 
regarding returning to the community.

[[Page 65]]

    (6) The resident has the right to have reasonable access to the use 
of a telephone, including TTY and TDD services, and a place in the 
facility where calls can be made without being overheard. This includes 
the right to retain and use a cellular phone at the resident's own 
expense.
    (7) The facility must protect and facilitate that resident's right 
to communicate with individuals and entities within and external to the 
facility, including reasonable access to:
    (i) A telephone, including TTY and TDD services;
    (ii) The internet, to the extent available to the facility; and
    (iii) Stationery, postage, writing implements and the ability to 
send mail.
    (8) The resident has the right to send and receive mail, and to 
receive letters, packages and other materials delivered to the facility 
for the resident through a means other than a postal service, including 
the right to:
    (i) Privacy of such communications consistent with this section; and
    (ii) Access to stationery, postage, and writing implements at the 
resident's own expense.
    (9) The resident has the right to have reasonable access to and 
privacy in their use of electronic communications such as email and 
video communications and for Internet research.
    (i) If the access is available to the facility
    (ii) At the resident's expense, if any additional expense is 
incurred by the facility to provide such access to the resident.
    (iii) Such use must comply with state and federal law.
    (10) The resident has the right to--
    (i) Examine the results of the most recent survey of the facility 
conducted by Federal or State surveyors and any plan of correction in 
effect with respect to the facility; and
    (ii) Receive information from agencies acting as client advocates, 
and be afforded the opportunity to contact these agencies.
    (11) The facility must--
    (i) Post in a place readily accessible to residents, and family 
members and legal representatives of residents, the results of the most 
recent survey of the facility.
    (ii) Have reports with respect to any surveys, certifications, and 
complaint investigations made respecting the facility during the 3 
preceding years, and any plan of correction in effect with respect to 
the facility, available for any individual to review upon request; and
    (iii) Post notice of the availability of such reports in areas of 
the facility that are prominent and accessible to the public.
    (iv) The facility shall not make available identifying information 
about complainants or residents.
    (12) The facility must comply with the requirements specified in 42 
CFR part 489, subpart I (Advance Directives).
    (i) These requirements include provisions to inform and provide 
written information to all adult residents concerning the right to 
accept or refuse medical or surgical treatment and, at the resident's 
option, formulate an advance directive.
    (ii) This includes a written description of the facility's policies 
to implement advance directives and applicable State law.
    (iii) Facilities are permitted to contract with other entities to 
furnish this information but are still legally responsible for ensuring 
that the requirements of this section are met.
    (iv) If an adult individual is incapacitated at the time of 
admission and is unable to receive information or articulate whether or 
not he or she has executed an advance directive, the facility may give 
advance directive information to the individual's resident 
representative in accordance with State law.
    (v) The facility is not relieved of its obligation to provide this 
information to the individual once he or she is able to receive such 
information. Follow-up procedures must be in place to provide the 
information to the individual directly at the appropriate time.
    (13) The facility must display in the facility written information, 
and provide to residents and applicants for admission, oral and written 
information about how to apply for and use Medicare and Medicaid 
benefits, and how to receive refunds for previous payments covered by 
such benefits.

[[Page 66]]

    (14) Notification of changes. (i) A facility must immediately inform 
the resident; consult with the resident's physician; and notify, 
consistent with his or her authority, the resident representative(s), 
when there is--
    (A) An accident involving the resident which results in injury and 
has the potential for requiring physician intervention;
    (B) A significant change in the resident's physical, mental, or 
psychosocial status (that is, a deterioration in health, mental, or 
psychosocial status in either life-threatening conditions or clinical 
complications);
    (C) A need to alter treatment significantly (that is, a need to 
discontinue or change an existing form of treatment due to adverse 
consequences, or to commence a new form of treatment); or
    (D) A decision to transfer or discharge the resident from the 
facility as specified in Sec. 483.15(c)(1)(ii).
    (ii) When making notification under paragraph (g)(14)(i) of this 
section, the facility must ensure that all pertinent information 
specified in Sec. 483.15(c)(2) is available and provided upon request 
to the physician.
    (iii) The facility must also promptly notify the resident and the 
resident representative, if any, when there is--
    (A) A change in room or roommate assignment as specified in Sec. 
483.10(e)(6); or
    (B) A change in resident rights under Federal or State law or 
regulations as specified in paragraph (e)(10) of this section.
    (iv) The facility must record and periodically update the address 
(mailing and email) and phone number of the resident representative(s).
    (15) Admission to a composite distinct part. A facility that is a 
composite distinct part (as defined in Sec. 483.5 must disclose in its 
admission agreement its physical configuration, including the various 
locations that comprise the composite distinct part, and must specify 
the policies that apply to room changes between its different locations 
under Sec. 483.15(c)(9).
    (16) The facility must provide a notice of rights and services to 
the resident prior to or upon admission and during the resident's stay.
    (i) The facility must inform the resident both orally and in writing 
in a language that the resident understands of his or her rights and all 
rules and regulations governing resident conduct and responsibilities 
during the stay in the facility.
    (ii) The facility must also provide the resident with the State-
developed notice of Medicaid rights and obligations, if any.
    (iii) Receipt of such information, and any amendments to it, must be 
acknowledged in writing;
    (17) The facility must--
    (i) Inform each Medicaid-eligible resident, in writing, at the time 
of admission to the nursing facility and when the resident becomes 
eligible for Medicaid of--
    (A) The items and services that are included in nursing facility 
services under the State plan and for which the resident may not be 
charged;
    (B) Those other items and services that the facility offers and for 
which the resident may be charged, and the amount of charges for those 
services; and
    (ii) Inform each Medicaid-eligible resident when changes are made to 
the items and services specified in Sec. 483.10(g)(17)(i)(A) and (B) of 
this section.
    (18) The facility must inform each resident before, or at the time 
of admission, and periodically during the resident's stay, of services 
available in the facility and of charges for those services, including 
any charges for services not covered under Medicare/Medicaid or by the 
facility's per diem rate.
    (i) Where changes in coverage are made to items and services covered 
by Medicare and/or by the Medicaid State plan, the facility must provide 
notice to residents of the change as soon as is reasonably possible.
    (ii) Where changes are made to charges for other items and services 
that the facility offers, the facility must inform the resident in 
writing at least 60 days prior to implementation of the change.
    (iii) If a resident dies or is hospitalized or is transferred and 
does not return to the facility, the facility must

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refund to the resident, resident representative, or estate, as 
applicable, any deposit or charges already paid, less the facility's per 
diem rate, for the days the resident actually resided or reserved or 
retained a bed in the facility, regardless of any minimum stay or 
discharge notice requirements.
    (iv) The facility must refund to the resident or resident 
representative any and all refunds due the resident within 30 days from 
the resident's date of discharge from the facility.
    (v) The terms of an admission contract by or on behalf of an 
individual seeking admission to the facility must not conflict with the 
requirements of these regulations.
    (h) Privacy and confidentiality. The resident has a right to 
personal privacy and confidentiality of his or her personal and medical 
records.
    (1) Personal privacy includes accommodations, medical treatment, 
written and telephone communications, personal care, visits, and 
meetings of family and resident groups, but this does not require the 
facility to provide a private room for each resident.
    (2) The facility must respect the residents right to personal 
privacy, including the right to privacy in his or her oral (that is, 
spoken), written, and electronic communications, including the right to 
send and promptly receive unopened mail and other letters, packages and 
other materials delivered to the facility for the resident, including 
those delivered through a means other than a postal service.
    (3) The resident has a right to secure and confidential personal and 
medical records.
    (i) The resident has the right to refuse the release of personal and 
medical records except as provided at Sec. 483.70(i)(2) or other 
applicable federal or state laws.
    (ii) The facility must allow representatives of the Office of the 
State Long-Term Care Ombudsman to examine a resident's medical, social, 
and administrative records in accordance with State law.
    (i) Safe environment. The resident has a right to a safe, clean, 
comfortable and homelike environment, including but not limited to 
receiving treatment and supports for daily living safely. The facility 
must provide--
    (1) A safe, clean, comfortable, and homelike environment, allowing 
the resident to use his or her personal belongings to the extent 
possible.
    (i) This includes ensuring that the resident can receive care and 
services safely and that the physical layout of the facility maximizes 
resident independence and does not pose a safety risk.
    (ii) The facility shall exercise reasonable care for the protection 
of the resident's property from loss or theft.
    (2) Housekeeping and maintenance services necessary to maintain a 
sanitary, orderly, and comfortable interior;
    (3) Clean bed and bath linens that are in good condition;
    (4) Private closet space in each resident room, as specified in 
Sec. 483.90(e)(2)(iv);
    (5) Adequate and comfortable lighting levels in all areas;
    (6) Comfortable and safe temperature levels. Facilities initially 
certified after October 1, 1990 must maintain a temperature range of 71 
to 81 [deg]F; and
    (7) For the maintenance of comfortable sound levels.
    (j) Grievances. (1) The resident has the right to voice grievances 
to the facility or other agency or entity that hears grievances without 
discrimination or reprisal and without fear of discrimination or 
reprisal. Such grievances include those with respect to care and 
treatment which has been furnished as well as that which has not been 
furnished, the behavior of staff and of other residents; and other 
concerns regarding their LTC facility stay.
    (2) The resident has the right to and the facility must make prompt 
efforts by the facility to resolve grievances the resident may have, in 
accordance with this paragraph.
    (3) The facility must make information on how to file a grievance or 
complaint available to the resident.
    (4) The facility must establish a grievance policy to ensure the 
prompt resolution of all grievances regarding the residents' rights 
contained in this paragraph. Upon request, the provider must give a copy 
of the grievance policy to the resident. The grievance policy must 
include:

[[Page 68]]

    (i) Notifying resident individually or through postings in prominent 
locations throughout the facility of the right to file grievances orally 
(meaning spoken) or in writing; the right to file grievances 
anonymously; the contact information of the grievance official with whom 
a grievance can be filed, that is, his or her name, business address 
(mailing and email) and business phone number; a reasonable expected 
time frame for completing the review of the grievance; the right to 
obtain a written decision regarding his or her grievance; and the 
contact information of independent entities with whom grievances may be 
filed, that is, the pertinent State agency, Quality Improvement 
Organization, State Survey Agency and State Long-Term Care Ombudsman 
program or protection and advocacy system;
    (ii) Identifying a Grievance Official who is responsible for 
overseeing the grievance process, receiving and tracking grievances 
through to their conclusion; leading any necessary investigations by the 
facility; maintaining the confidentiality of all information associated 
with grievances, for example, the identity of the resident for those 
grievances submitted anonymously; issuing written grievance decisions to 
the resident; and coordinating with state and federal agencies as 
necessary in light of specific allegations;
    (iii) As necessary, taking immediate action to prevent further 
potential violations of any resident right while the alleged violation 
is being investigated;
    (iv) Consistent with Sec. 483.12(c)(1), immediately reporting all 
alleged violations involving neglect, abuse, including injuries of 
unknown source, and/or misappropriation of resident property, by anyone 
furnishing services on behalf of the provider, to the administrator of 
the provider; and as required by State law;
    (v) Ensuring that all written grievance decisions include the date 
the grievance was received, a summary statement of the resident's 
grievance, the steps taken to investigate the grievance, a summary of 
the pertinent findings or conclusions regarding the resident's 
concern(s), a statement as to whether the grievance was confirmed or not 
confirmed, any corrective action taken or to be taken by the facility as 
a result of the grievance, and the date the written decision was issued;
    (vi) Taking appropriate corrective action in accordance with State 
law if the alleged violation of the residents' rights is confirmed by 
the facility or if an outside entity having jurisdiction, such as the 
State Survey Agency, Quality Improvement Organization, or local law 
enforcement agency confirms a violation of any of these residents' 
rights within its area of responsibility; and
    (vii) Maintaining evidence demonstrating the results of all 
grievances for a period of no less than 3 years from the issuance of the 
grievance decision.
    (k) Contact with external entities. A facility must not prohibit or 
in any way discourage a resident from communicating with federal, state, 
or local officials, including, but not limited to, federal and state 
surveyors, other federal or state health department employees, including 
representatives of the Office of the State Long-Term Care Ombudsman, and 
any representative of the agency responsible for the protection and 
advocacy system for individuals with mental disorder (established under 
the Protection and Advocacy for Mentally Ill Individuals Act of 2000 (42 
U.S.C. 10801 et seq.), regarding any matter, whether or not subject to 
arbitration or any other type of judicial or regulatory action.

[81 FR 68849, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.12  Freedom from abuse, neglect, and exploitation.

    The resident has the right to be free from abuse, neglect, 
misappropriation of resident property, and exploitation as defined in 
this subpart. This includes but is not limited to freedom from corporal 
punishment, involuntary seclusion and any physical or chemical restraint 
not required to treat the resident's medical symptoms.
    (a) The facility must--
    (1) Not use verbal, mental, sexual, or physical abuse, corporal 
punishment, or involuntary seclusion;
    (2) Ensure that the resident is free from physical or chemical 
restraints imposed for purposes of discipline or convenience and that 
are not required

[[Page 69]]

to treat the resident's medical symptoms. When the use of restraints is 
indicated, the facility must use the least restrictive alternative for 
the least amount of time and document ongoing re-evaluation of the need 
for restraints.
    (3) Not employ or otherwise engage individuals who--
    (i) Have been found guilty of abuse, neglect, exploitation, 
misappropriation of property, or mistreatment by a court of law;
    (ii) Have had a finding entered into the State nurse aide registry 
concerning abuse, neglect, exploitation, mistreatment of residents or 
misappropriation of their property; or
    (iii) Have a disciplinary action in effect against his or her 
professional license by a state licensure body as a result of a finding 
of abuse, neglect, exploitation, mistreatment of residents or 
misappropriation of resident property.
    (4) Report to the State nurse aide registry or licensing authorities 
any knowledge it has of actions by a court of law against an employee, 
which would indicate unfitness for service as a nurse aide or other 
facility staff.
    (b) The facility must develop and implement written policies and 
procedures that:
    (1) Prohibit and prevent abuse, neglect, and exploitation of 
residents and misappropriation of resident property,
    (2) Establish policies and procedures to investigate any such 
allegations, and
    (3) Include training as required at paragraph Sec. 483.95.
    (4) Establish coordination with the QAPI program required under 
Sec. 483.75.
    (5) Ensure reporting of crimes occurring in federally-funded long-
term care facilities in accordance with section 1150B of the Act. The 
policies and procedures must include but are not limited to the 
following elements.
    (i) Annually notifying covered individuals, as defined at section 
1150B(a)(3) of the Act, of that individual's obligation to comply with 
the following reporting requirements.
    (A) Each covered individual shall report to the State Agency and one 
or more law enforcement entities for the political subdivision in which 
the facility is located any reasonable suspicion of a crime against any 
individual who is a resident of, or is receiving care from, the 
facility.
    (B) Each covered individual shall report immediately, but not later 
than 2 hours after forming the suspicion, if the events that cause the 
suspicion result in serious bodily injury, or not later than 24 hours if 
the events that cause the suspicion do not result in serious bodily 
injury.
    (ii) Posting a conspicuous notice of employee rights, as defined at 
section 1150B(d)(3) of the Act.
    (iii) Prohibiting and preventing retaliation, as defined at section 
1150B(d)(1) and (2) of the Act.
    (c) In response to allegations of abuse, neglect, exploitation, or 
mistreatment, the facility must:
    (1) Ensure that all alleged violations involving abuse, neglect, 
exploitation or mistreatment, including injuries of unknown source and 
misappropriation of resident property, are reported immediately, but not 
later than 2 hours after the allegation is made, if the events that 
cause the allegation involve abuse or result in serious bodily injury, 
or not later than 24 hours if the events that cause the allegation do 
not involve abuse and do not result in serious bodily injury, to the 
administrator of the facility and to other officials (including to the 
State Survey Agency and adult protective services where state law 
provides for jurisdiction in long-term care facilities) in accordance 
with State law through established procedures.
    (2) Have evidence that all alleged violations are thoroughly 
investigated.
    (3) Prevent further potential abuse, neglect, exploitation, or 
mistreatment while the investigation is in progress.
    (4) Report the results of all investigations to the administrator or 
his or her designated representative and to other officials in 
accordance with State law, including to the State Survey Agency, within 
5 working days of the incident, and if the alleged violation is verified 
appropriate corrective action must be taken.

[81 FR 68855, Oct. 4, 2016]

[[Page 70]]



Sec. 483.15  Admission, transfer, and discharge rights.

    (a) Admissions policy. (1) The facility must establish and implement 
an admissions policy.
    (2) The facility must--
    (i) Not request or require residents or potential residents to waive 
their rights as set forth in this subpart and in applicable state, 
federal or local licensing or certification laws, including but not 
limited to their rights to Medicare or Medicaid; and
    (ii) Not request or require oral or written assurance that residents 
or potential residents are not eligible for, or will not apply for, 
Medicare or Medicaid benefits.
    (iii) Not request or require residents or potential residents to 
waive potential facility liability for losses of personal property
    (3) The facility must not request or require a third party guarantee 
of payment to the facility as a condition of admission or expedited 
admission, or continued stay in the facility. However, the facility may 
request and require a resident representative who has legal access to a 
resident's income or resources available to pay for facility care to 
sign a contract, without incurring personal financial liability, to 
provide facility payment from the resident's income or resources.
    (4) In the case of a person eligible for Medicaid, a nursing 
facility must not charge, solicit, accept, or receive, in addition to 
any amount otherwise required to be paid under the State plan, any gift, 
money, donation, or other consideration as a precondition of admission, 
expedited admission or continued stay in the facility. However,--
    (i) A nursing facility may charge a resident who is eligible for 
Medicaid for items and services the resident has requested and received, 
and that are not specified in the State plan as included in the term 
``nursing facility services'' so long as the facility gives proper 
notice of the availability and cost of these services to residents and 
does not condition the resident's admission or continued stay on the 
request for and receipt of such additional services; and
    (ii) A nursing facility may solicit, accept, or receive a 
charitable, religious, or philanthropic contribution from an 
organization or from a person unrelated to a Medicaid eligible resident 
or potential resident, but only to the extent that the contribution is 
not a condition of admission, expedited admission, or continued stay in 
the facility for a Medicaid eligible resident.
    (5) States or political subdivisions may apply stricter admissions 
standards under State or local laws than are specified in this section, 
to prohibit discrimination against individuals entitled to Medicaid.
    (6) A nursing facility must disclose and provide to a resident or 
potential resident prior to time of admission, notice of special 
characteristics or service limitations of the facility.
    (7) A nursing facility that is a composite distinct part as defined 
in Sec. 483.5 must disclose in its admission agreement its physical 
configuration, including the various locations that comprise the 
composite distinct part, and must specify the policies that apply to 
room changes between its different locations under paragraph (c)(9) of 
this section.
    (b) Equal access to quality care. (1) A facility must establish, 
maintain and implement identical policies and practices regarding 
transfer and discharge, as defined in Sec. 483.5 and the provision of 
services for all individuals regardless of source of payment, consistent 
with Sec. 483.10(a)(2);
    (2) The facility may charge any amount for services furnished to 
non-Medicaid residents unless otherwise limited by state law and 
consistent with the notice requirement in Sec. 483.10(g)(18)(i) and 
(g)(4)(i) describing the charges; and
    (3) The State is not required to offer additional services on behalf 
of a resident other than services provided in the State plan.
    (c) Transfer and discharge--(1) Facility requirements--(i) The 
facility must permit each resident to remain in the facility, and not 
transfer or discharge the resident from the facility unless--
    (A) The transfer or discharge is necessary for the resident's 
welfare and the resident's needs cannot be met in the facility;
    (B) The transfer or discharge is appropriate because the resident's 
health

[[Page 71]]

has improved sufficiently so the resident no longer needs the services 
provided by the facility;
    (C) The safety of individuals in the facility is endangered due to 
the clinical or behavioral status of the resident;
    (D) The health of individuals in the facility would otherwise be 
endangered;
    (E) The resident has failed, after reasonable and appropriate 
notice, to pay for (or to have paid under Medicare or Medicaid) a stay 
at the facility. Non-payment applies if the resident does not submit the 
necessary paperwork for third party payment or after the third party, 
including Medicare or Medicaid, denies the claim and the resident 
refuses to pay for his or her stay. For a resident who becomes eligible 
for Medicaid after admission to a facility, the facility may charge a 
resident only allowable charges under Medicaid; or
    (F) The facility ceases to operate.
    (ii) The facility may not transfer or discharge the resident while 
the appeal is pending, pursuant to Sec. 431.230 of this chapter, when a 
resident exercises his or her right to appeal a transfer or discharge 
notice from the facility pursuant to Sec. 431.220(a)(3) of this 
chapter, unless the failure to discharge or transfer would endanger the 
health or safety of the resident or other individuals in the facility. 
The facility must document the danger that failure to transfer or 
discharge would pose.
    (2) Documentation. When the facility transfers or discharges a 
resident under any of the circumstances specified in paragraphs 
(c)(1)(i)(A) through (F) of this section, the facility must ensure that 
the transfer or discharge is documented in the resident's medical record 
and appropriate information is communicated to the receiving health care 
institution or provider.
    (i) Documentation in the resident's medical record must include:
    (A) The basis for the transfer per paragraph (c)(1)(i) of this 
section.
    (B) In the case of paragraph (c)(1)(i)(A) of this section, the 
specific resident need(s) that cannot be met, facility attempts to meet 
the resident needs, and the service available at the receiving facility 
to meet the need(s).
    (ii) The documentation required by paragraph (c)(2)(i) of this 
section must be made by--
    (A) The resident's physician when transfer or discharge is necessary 
under paragraph (c)(1)(A) or (B) of this section; and
    (B) A physician when transfer or discharge is necessary under 
paragraph (c)(1)(i)(C) or (D) of this section.
    (iii) Information provided to the receiving provider must include a 
minimum of the following:
    (A) Contact information of the practitioner responsible for the care 
of the resident
    (B) Resident representative information including contact 
information.
    (C) Advance Directive information.
    (D) All special instructions or precautions for ongoing care, as 
appropriate.
    (E) Comprehensive care plan goals,
    (F) All other necessary information, including a copy of the 
resident's discharge summary, consistent with Sec. 483.21(c)(2), as 
applicable, and any other documentation, as applicable, to ensure a safe 
and effective transition of care.
    (3) Notice before transfer. Before a facility transfers or 
discharges a resident, the facility must--
    (i) Notify the resident and the resident's representative(s) of the 
transfer or discharge and the reasons for the move in writing and in a 
language and manner they understand. The facility must send a copy of 
the notice to a representative of the Office of the State Long-Term Care 
Ombudsman.
    (ii) Record the reasons for the transfer or discharge in the 
resident's medical record in accordance with paragraph (c)(2) of this 
section; and
    (iii) Include in the notice the items described in paragraph (c)(5) 
of this section.
    (4) Timing of the notice. (i) Except as specified in paragraphs 
(c)(4)(ii) and (8) of this section, the notice of transfer or discharge 
required under this section must be made by the facility at least 30 
days before the resident is transferred or discharged.
    (ii) Notice must be made as soon as practicable before transfer or 
discharge when--

[[Page 72]]

    (A) The safety of individuals in the facility would be endangered 
under paragraph (c)(1)(i)(C) of this section;
    (B) The health of individuals in the facility would be endangered, 
under paragraph (c)(1)(i)(D) of this section;
    (C) The resident's health improves sufficiently to allow a more 
immediate transfer or discharge, under paragraph (c)(1)(i)(B) of this 
section;
    (D) An immediate transfer or discharge is required by the resident's 
urgent medical needs, under paragraph (c)(1)(i)(A) of this section; or
    (E) A resident has not resided in the facility for 30 days.
    (5) Contents of the notice. The written notice specified in 
paragraph (c)(3) of this section must include the following:
    (i) The reason for transfer or discharge;
    (ii) The effective date of transfer or discharge;
    (iii) The location to which the resident is transferred or 
discharged;
    (iv) A statement of the resident's appeal rights, including the 
name, address (mailing and email), and telephone number of the entity 
which receives such requests; and information on how to obtain an appeal 
form and assistance in completing the form and submitting the appeal 
hearing request;
    (v) The name, address (mailing and email) and telephone number of 
the Office of the State Long-Term Care Ombudsman;
    (vi) For nursing facility residents with intellectual and 
developmental disabilities or related disabilities, the mailing and 
email address and telephone number of the agency responsible for the 
protection and advocacy of individuals with developmental disabilities 
established under Part C of the Developmental Disabilities Assistance 
and Bill of Rights Act of 2000 (Pub. L. 106-402, codified at 42 U.S.C. 
15001 et seq.); and
    (vii) For nursing facility residents with a mental disorder or 
related disabilities, the mailing and email address and telephone number 
of the agency responsible for the protection and advocacy of individuals 
with a mental disorder established under the Protection and Advocacy for 
Mentally Ill Individuals Act.
    (6) Changes to the notice. If the information in the notice changes 
prior to effecting the transfer or discharge, the facility must update 
the recipients of the notice as soon as practicable once the updated 
information becomes available.
    (7) Orientation for transfer or discharge. A facility must provide 
and document sufficient preparation and orientation to residents to 
ensure safe and orderly transfer or discharge from the facility. This 
orientation must be provided in a form and manner that the resident can 
understand.
    (8) Notice in advance of facility closure. In the case of facility 
closure, the individual who is the administrator of the facility must 
provide written notification prior to the impending closure to the State 
Survey Agency, the Office of the State Long-Term Care Ombudsman, 
residents of the facility, and the resident representatives, as well as 
the plan for the transfer and adequate relocation of the residents, as 
required at Sec. 483.70(l).
    (9) Room changes in a composite distinct part. Room changes in a 
facility that is a composite distinct part (as defined in Sec. 483.5) 
are subject to the requirements of Sec. 483.10(e)(7) and must be 
limited to moves within the particular building in which the resident 
resides, unless the resident voluntarily agrees to move to another of 
the composite distinct part's locations.
    (d) Notice of bed-hold policy and return--(1) Notice before 
transfer. Before a nursing facility transfers a resident to a hospital 
or the resident goes on therapeutic leave, the nursing facility must 
provide written information to the resident or resident representative 
that specifies--
    (i) The duration of the state bed-hold policy, if any, during which 
the resident is permitted to return and resume residence in the nursing 
facility;
    (ii) The reserve bed payment policy in the state plan, under Sec. 
447.40 of this chapter, if any;
    (iii) The nursing facility's policies regarding bed-hold periods, 
which must be consistent with paragraph (e)(1) of this section, 
permitting a resident to return; and
    (iv) The information specified in paragraph (e)(1) of this section.

[[Page 73]]

    (2) Bed-hold notice upon transfer. At the time of transfer of a 
resident for hospitalization or therapeutic leave, a nursing facility 
must provide to the resident and the resident representative written 
notice which specifies the duration of the bed-hold policy described in 
paragraph (d)(1) of this section.
    (e)(1) Permitting residents to return to facility. A facility must 
establish and follow a written policy on permitting residents to return 
to the facility after they are hospitalized or placed on therapeutic 
leave. The policy must provide for the following.
    (i) A resident, whose hospitalization or therapeutic leave exceeds 
the bed-hold period under the State plan, returns to the facility to 
their previous room if available or immediately upon the first 
availability of a bed in a semi-private room if the resident
    (A) Requires the services provided by the facility; and
    (B) Is eligible for Medicare skilled nursing facility services or 
Medicaid nursing facility services.
    (ii) If the facility that determines that a resident who was 
transferred with an expectation of returning to the facility cannot 
return to the facility, the facility must comply with the requirements 
of paragraph (c) as they apply to discharges.
    (2) Readmission to a composite distinct part. When the facility to 
which a resident returns is a composite distinct part (as defined in 
Sec. 483.5), the resident must be permitted to return to an available 
bed in the particular location of the composite distinct part in which 
he or she resided previously. If a bed is not available in that location 
at the time of return, the resident must be given the option to return 
to that location upon the first availability of a bed there.

[81 FR 68855, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.20  Resident assessment.

    The facility must conduct initially and periodically a 
comprehensive, accurate, standardized, reproducible assessment of each 
resident's functional capacity.
    (a) Admission orders. At the time each resident is admitted, the 
facility must have physician orders for the resident's immediate care.
    (b) Comprehensive assessments--(1) Resident assessment instrument. A 
facility must make a comprehensive assessment of a resident's needs, 
strengths, goals, life history and preferences, using the resident 
assessment instrument (RAI) specified by CMS. The assessment must 
include at least the following:
    (i) Identification and demographic information.
    (ii) Customary routine.
    (iii) Cognitive patterns.
    (iv) Communication.
    (v) Vision.
    (vi) Mood and behavior patterns.
    (vii) Psychosocial well-being.
    (viii) Physical functioning and structural problems.
    (ix) Continence.
    (x) Disease diagnoses and health conditions.
    (xi) Dental and nutritional status.
    (xii) Skin condition.
    (xiii) Activity pursuit.
    (xiv) Medications.
    (xv) Special treatments and procedures.
    (xvi) Discharge planning.
    (xvii) Documentation of summary information regarding the additional 
assessment performed on the care areas triggered by the completion of 
the Minimum Data Set (MDS).
    (xviii) Documentation of participation in assessment. The assessment 
process must include direct observation and communication with the 
resident, as well as communication with licensed and nonlicensed direct 
care staff members on all shifts.
    (2) When required. Subject to the timeframes prescribed in Sec. 
413.343(b) of this chapter, a facility must conduct a comprehensive 
assessment of a resident in accordance with the timeframes specified in 
paragraphs (b)(2) (i) through (iii) of this section. The timeframes 
prescribed in Sec. 413.343(b) of this chapter do not apply to CAHs.
    (i) Within 14 calendar days after admission, excluding readmissions 
in which there is no significant change in the resident's physical or 
mental condition. (For purposes of this section, ``readmission'' means a 
return to the facility following a temporary absence

[[Page 74]]

for hospitalization or for therapeutic leave.)
    (ii) Within 14 calendar days after the facility determines, or 
should have determined, that there has been a significant change in the 
resident's physical or mental condition. (For purposes of this section, 
a ``significant change'' means a major decline or improvement in the 
resident's status that will not normally resolve itself without further 
intervention by staff or by implementing standard disease-related 
clinical interventions, that has an impact on more than one area of the 
resident's health status, and requires interdisciplinary review or 
revision of the care plan, or both.)
    (iii) Not less often than once every 12 months.
    (c) Quarterly review assessment. A facility must assess a resident 
using the quarterly review instrument specified by the State and 
approved by CMS not less frequently than once every 3 months.
    (d) Use. A facility must maintain all resident assessments completed 
within the previous 15 months in the resident's active record and use 
the results of the assessments to develop, review, and revise the 
resident's comprehensive plan of care.
    (e) Coordination. A facility must coordinate assessments with the 
preadmission screening and resident review (PASARR) program under 
Medicaid in subpart C of this part to the maximum extent practicable to 
avoid duplicative testing and effort. Coordination includes--
    (1) Incorporating the recommendations from the PASARR level II 
determination and the PASARR evaluation report into a resident's 
assessment, care planning, and transitions of care.
    (2) Referring all level II residents and all residents with newly 
evident or possible serious mental disorder, intellectual disability, or 
a related condition for level II resident review upon a significant 
change in status assessment.
    (f) Automated data processing requirement--(1) Encoding data. Within 
7 days after a facility completes a resident's assessment, a facility 
must encode the following information for each resident in the facility:
    (i) Admission assessment.
    (ii) Annual assessment updates.
    (iii) Significant change in status assessments.
    (iv) Quarterly review assessments.
    (v) A subset of items upon a resident's transfer, reentry, 
discharge, and death.
    (vi) Background (face-sheet) information, if there is no admission 
assessment.
    (2) Transmitting data. Within 7 days after a facility completes a 
resident's assessment, a facility must be capable of transmitting to the 
CMS System information for each resident contained in the MDS in a 
format that conforms to standard record layouts and data dictionaries, 
and that passes standardized edits defined by CMS and the State.
    (3) Transmittal requirements. Within 14 days after a facility 
completes a resident's assessment, a facility must electronically 
transmit encoded, accurate, and complete MDS data to the CMS System, 
including the following:
    (i) Admission assessment.
    (ii) Annual assessment.
    (iii) Significant change in status assessment.
    (iv) Significant correction of prior full assessment.
    (v) Significant correction of prior quarterly assessment.
    (vi) Quarterly review.
    (vii) A subset of items upon a resident's transfer, reentry, 
discharge, and death.
    (viii) Background (face-sheet) information, for an initial 
transmission of MDS data on a resident that does not have an admission 
assessment.
    (4) Data format. The facility must transmit data in the format 
specified by CMS or, for a State which has an alternate RAI approved by 
CMS, in the format specified by the State and approved by CMS.
    (5) Resident-identifiable information. (i) A facility may not 
release information that is resident-identifiable to the public.
    (ii) The facility may release information that is resident-
identifiable to an agent only in accordance with a contract under which 
the agent agrees not to use or disclose the information except to the 
extent the facility itself is permitted to do so.

[[Page 75]]

    (g) Accuracy of assessments. The assessment must accurately reflect 
the resident's status.
    (h) Coordination. A registered nurse must conduct or coordinate each 
assessment with the appropriate participation of health professionals.
    (i) Certification. (1) A registered nurse must sign and certify that 
the assessment is completed.
    (2) Each individual who completes a portion of the assessment must 
sign and certify the accuracy of that portion of the assessment.
    (j) Penalty for falsification. (1) Under Medicare and Medicaid, an 
individual who willfully and knowingly--
    (i) Certifies a material and false statement in a resident 
assessment is subject to a civil money penalty of not more than $1,000 
as adjusted annually under 45 CFR part 102 for each assessment; or
    (ii) Causes another individual to certify a material and false 
statement in a resident assessment is subject to a civil money penalty 
of not more than $5,000 as adjusted annually under 45 CFR part 102 for 
each assessment.
    (2) Clinical disagreement does not constitute a material and false 
statement.
    (k) Preadmission screening for individuals with a mental disorder 
and individuals with intellectual disability. (1) A nursing facility 
must not admit, on or after January 1, 1989, any new resident with--
    (i) Mental disorder as defined in paragraph (k)(3)(i) of this 
section, unless the State mental health authority has determined, based 
on an independent physical and mental evaluation performed by a person 
or entity other than the State mental health authority, prior to 
admission,
    (A) That, because of the physical and mental condition of the 
individual, the individual requires the level of services provided by a 
nursing facility; and
    (B) If the individual requires such level of services, whether the 
individual requires specialized services; or
    (ii) Intellectual disability, as defined in paragraph (k)(3)(ii) of 
this section, unless the State intellectual disability or developmental 
disability authority has determined prior to admission--
    (A) That, because of the physical and mental condition of the 
individual, the individual requires the level of services provided by a 
nursing facility; and
    (B) If the individual requires such level of services, whether the 
individual requires specialized services for intellectual disability.
    (2) Exceptions. For purposes of this section--
    (i) The preadmission screening program under paragraph (k)(1) of 
this section need not provide for determinations in the case of the 
readmission to a nursing facility of an individual who, after being 
admitted to the nursing facility, was transferred for care in a 
hospital.
    (ii) The State may choose not to apply the preadmission screening 
program under paragraph (k)(1) of this section to the admission to a 
nursing facility of an individual--
    (A) Who is admitted to the facility directly from a hospital after 
receiving acute inpatient care at the hospital,
    (B) Who requires nursing facility services for the condition for 
which the individual received care in the hospital, and
    (C) Whose attending physician has certified, before admission to the 
facility that the individual is likely to require less than 30 days of 
nursing facility services.
    (3) Definition. For purposes of this section--
    (i) An individual is considered to have a mental disorder if the 
individual has a serious mental disorder as defined in Sec. 
483.102(b)(1).
    (ii) An individual is considered to have an intellectual disability 
if the individual has an intellectual disability as defined in Sec. 
483.102(b)(3) or is a person with a related condition as described in 
Sec. 435.1010 of this chapter.
    (4) A nursing facility must notify the state mental health authority 
or state intellectual disability authority, as applicable, promptly 
after a significant

[[Page 76]]

change in the mental or physical condition of a resident who has a 
mental disorder or intellectual disability for resident review.

[56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992; 
62 FR 67211, Dec. 23, 1997; 63 FR 53307, Oct. 5, 1998; 64 FR 41543, July 
30, 1999; 68 FR 46072, Aug. 4, 2003; 71 FR 39229, July 12, 2006; 74 FR 
40363, Aug. 11, 2009; 81 FR 61563, Sept. 6, 2016; 81 FR 68857, Oct. 4, 
2016]



Sec. 483.21  Comprehensive person-centered care planning.

    (a) Baseline care plans. (1) The facility must develop and implement 
a baseline care plan for each resident that includes the instructions 
needed to provide effective and person-centered care of the resident 
that meet professional standards of quality care. The baseline care plan 
must--
    (i) Be developed within 48 hours of a resident's admission.
    (ii) Include the minimum healthcare information necessary to 
properly care for a resident including, but not limited to:
    (A) Initial goals based on admission orders.
    (B) Physician orders.
    (C) Dietary orders.
    (D) Therapy services.
    (E) Social services.
    (F) PASARR recommendation, if applicable.
    (2) The facility may develop a comprehensive care plan in place of 
the baseline care plan if the comprehensive care plan--
    (i) Is developed within 48 hours of the resident's admission.
    (ii) Meets the requirements set forth in paragraph (b) of this 
section (excepting paragraph (b)(2)(i) of this section).
    (3) The facility must provide the resident and their representative 
with a summary of the baseline care plan that includes but is not 
limited to:
    (i) The initial goals of the resident.
    (ii) A summary of the resident's medications and dietary 
instructions.
    (iii) Any services and treatments to be administered by the facility 
and personnel acting on behalf of the facility.
    (iv) Any updated information based on the details of the 
comprehensive care plan, as necessary.
    (b) Comprehensive care plans. (1) The facility must develop and 
implement a comprehensive person-centered care plan for each resident, 
consistent with the resident rights set forth at Sec. 483.10(c)(2) and 
Sec. 483.10(c)(3), that includes measurable objectives and timeframes 
to meet a resident's medical, nursing, and mental and psychosocial needs 
that are identified in the comprehensive assessment. The comprehensive 
care plan must describe the following:
    (i) The services that are to be furnished to attain or maintain the 
resident's highest practicable physical, mental, and psychosocial well-
being as required under Sec. 483.24, Sec. 483.25, or Sec. 483.40; and
    (ii) Any services that would otherwise be required under Sec. 
483.24, Sec. 483.25, or Sec. 483.40 but are not provided due to the 
resident's exercise of rights under Sec. 483.10, including the right to 
refuse treatment under Sec. 483.10(c)(6).
    (iii) Any specialized services or specialized rehabilitative 
services the nursing facility will provide as a result of PASARR 
recommendations. If a facility disagrees with the findings of the 
PASARR, it must indicate its rationale in the resident's medical record.
    (iv) In consultation with the resident and the resident's 
representative(s)--
    (A) The resident's goals for admission and desired outcomes.
    (B) The resident's preference and potential for future discharge. 
Facilities must document whether the resident's desire to return to the 
community was assessed and any referrals to local contact agencies and/
or other appropriate entities, for this purpose.
    (C) Discharge plans in the comprehensive care plan, as appropriate, 
in accordance with the requirements set forth in paragraph (c) of this 
section.
    (2) A comprehensive care plan must be--
    (i) Developed within 7 days after completion of the comprehensive 
assessment.
    (ii) Prepared by an interdisciplinary team, that includes but is not 
limited to--
    (A) The attending physician.
    (B) A registered nurse with responsibility for the resident.

[[Page 77]]

    (C) A nurse aide with responsibility for the resident.
    (D) A member of food and nutrition services staff.
    (E) To the extent practicable, the participation of the resident and 
the resident's representative(s). An explanation must be included in a 
resident's medical record if the participation of the resident and their 
resident representative is determined not practicable for the 
development of the resident's care plan.
    (F) Other appropriate staff or professionals in disciplines as 
determined by the resident's needs or as requested by the resident.
    (iii) Reviewed and revised by the interdisciplinary team after each 
assessment, including both the comprehensive and quarterly review 
assessments.
    (3) The services provided or arranged by the facility, as outlined 
by the comprehensive care plan, must--
    (i) Meet professional standards of quality.
    (ii) Be provided by qualified persons in accordance with each 
resident's written plan of care.
    (iii) Be culturally-competent and trauma-informed.
    (c) Discharge planning--(1) Discharge planning process. The facility 
must develop and implement an effective discharge planning process that 
focuses on the resident's discharge goals, the preparation of residents 
to be active partners and effectively transition them to post-discharge 
care, and the reduction of factors leading to preventable readmissions. 
The facility's discharge planning process must be consistent with the 
discharge rights set forth at Sec. 483.15(b) as applicable and--
    (i) Ensure that the discharge needs of each resident are identified 
and result in the development of a discharge plan for each resident.
    (ii) Include regular re-evaluation of residents to identify changes 
that require modification of the discharge plan. The discharge plan must 
be updated, as needed, to reflect these changes.
    (iii) Involve the interdisciplinary team, as defined by Sec. 
483.21(b)(2)(ii), in the ongoing process of developing the discharge 
plan.
    (iv) Consider caregiver/support person availability and the 
resident's or caregiver's/support person(s) capacity and capability to 
perform required care, as part of the identification of discharge needs.
    (v) Involve the resident and resident representative in the 
development of the discharge plan and inform the resident and resident 
representative of the final plan.
    (vi) Address the resident's goals of care and treatment preferences.
    (vii) Document that a resident has been asked about their interest 
in receiving information regarding returning to the community.
    (A) If the resident indicates an interest in returning to the 
community, the facility must document any referrals to local contact 
agencies or other appropriate entities made for this purpose.
    (B) Facilities must update a resident's comprehensive care plan and 
discharge plan, as appropriate, in response to information received from 
referrals to local contact agencies or other appropriate entities.
    (C) If discharge to the community is determined to not be feasible, 
the facility must document who made the determination and why.
    (viii) For residents who are transferred to another SNF or who are 
discharged to a HHA, IRF, or LTCH, assist residents and their resident 
representatives in selecting a post-acute care provider by using data 
that includes, but is not limited to SNF, HHA, IRF, or LTCH standardized 
patient assessment data, data on quality measures, and data on resource 
use to the extent the data is available. The facility must ensure that 
the post-acute care standardized patient assessment data, data on 
quality measures, and data on resource use is relevant and applicable to 
the resident's goals of care and treatment preferences.
    (ix) Document, complete on a timely basis based on the resident's 
needs, and include in the clinical record, the evaluation of the 
resident's discharge needs and discharge plan. The results of the 
evaluation must be discussed with the resident or resident's 
representative. All relevant resident information must be incorporated 
into the discharge plan

[[Page 78]]

to facilitate its implementation and to avoid unnecessary delays in the 
resident's discharge or transfer.
    (2) Discharge summary. When the facility anticipates discharge a 
resident must have a discharge summary that includes, but is not limited 
to, the following:
    (i) A recapitulation of the resident's stay that includes, but is 
not limited to, diagnoses, course of illness/treatment or therapy, and 
pertinent lab, radiology, and consultation results.
    (ii) A final summary of the resident's status to include items in 
paragraph (b)(1) of Sec. 483.20, at the time of the discharge that is 
available for release to authorized persons and agencies, with the 
consent of the resident or resident's representative.
    (iii) Reconciliation of all pre-discharge medications with the 
resident's post-discharge medications (both prescribed and over-the-
counter).
    (iv) A post-discharge plan of care that is developed with the 
participation of the resident and, with the resident's consent, the 
resident representative(s), which will assist the resident to adjust to 
his or her new living environment. The post-discharge plan of care must 
indicate where the individual plans to reside, any arrangements that 
have been made for the resident's follow up care and any post-discharge 
medical and non-medical services.

[81 FR 68858, Oct. 4, 2016]



Sec. 483.24  Quality of life.

    Quality of life is a fundamental principle that applies to all care 
and services provided to facility residents. Each resident must receive 
and the facility must provide the necessary care and services to attain 
or maintain the highest practicable physical, mental, and psychosocial 
well-being, consistent with the resident's comprehensive assessment and 
plan of care.
    (a) Based on the comprehensive assessment of a resident and 
consistent with the resident's needs and choices, the facility must 
provide the necessary care and services to ensure that a resident's 
abilities in activities of daily living do not diminish unless 
circumstances of the individual's clinical condition demonstrate that 
such diminution was unavoidable. This includes the facility ensuring 
that:
    (1) A resident is given the appropriate treatment and services to 
maintain or improve his or her ability to carry out the activities of 
daily living, including those specified in paragraph (b) of this 
section,
    (2) A resident who is unable to carry out activities of daily living 
receives the necessary services to maintain good nutrition, grooming, 
and personal and oral hygiene, and
    (3) Personnel provide basic life support, including CPR, to a 
resident requiring such emergency care prior to the arrival of emergency 
medical personnel and subject to related physician orders and the 
resident's advance directives.
    (b) Activities of daily living. The facility must provide care and 
services in accordance with paragraph (a) of this section for the 
following activities of daily living:
    (1) Hygiene--bathing, dressing, grooming, and oral care,
    (2) Mobility--transfer and ambulation, including walking,
    (3) Elimination--toileting,
    (4) Dining--eating, including meals and snacks,
    (5) Communication, including
    (i) Speech,
    (ii) Language,
    (iii) Other functional communication systems.
    (c) Activities. (1) The facility must provide, based on the 
comprehensive assessment and care plan and the preferences of each 
resident, an ongoing program to support residents in their choice of 
activities, both facility-sponsored group and individual activities and 
independent activities, designed to meet the interests of and support 
the physical, mental, and psychosocial well-being of each resident, 
encouraging both independence and interaction in the community.
    (2) The activities program must be directed by a qualified 
professional who is a qualified therapeutic recreation specialist or an 
activities professional who--
    (i) Is licensed or registered, if applicable, by the State in which 
practicing; and
    (ii) Is:

[[Page 79]]

    (A) Eligible for certification as a therapeutic recreation 
specialist or as an activities professional by a recognized accrediting 
body on or after October 1, 1990; or
    (B) Has 2 years of experience in a social or recreational program 
within the last 5 years, one of which was full-time in a therapeutic 
activities program; or
    (C) Is a qualified occupational therapist or occupational therapy 
assistant; or
    (D) Has completed a training course approved by the State.

[81 FR 68859, Oct. 4, 2016]



Sec. 483.25  Quality of care.

    Quality of care is a fundamental principle that applies to all 
treatment and care provided to facility residents. Based on the 
comprehensive assessment of a resident, the facility must ensure that 
residents receive treatment and care in accordance with professional 
standards of practice, the comprehensive person-centered care plan, and 
the resident's choices, including but not limited to the following:
    (a) Vision and hearing. To ensure that residents receive proper 
treatment and assistive devices to maintain vision and hearing 
abilities, the facility must, if necessary, assist the resident--
    (1) In making appointments, and
    (2) By arranging for transportation to and from the office of a 
practitioner specializing in the treatment of vision or hearing 
impairment or the office of a professional specializing in the provision 
of vision or hearing assistive devices.
    (b) Skin integrity--(1) Pressure ulcers. Based on the comprehensive 
assessment of a resident, the facility must ensure that--
    (i) A resident receives care, consistent with professional standards 
of practice, to prevent pressure ulcers and does not develop pressure 
ulcers unless the individual's clinical condition demonstrates that they 
were unavoidable; and
    (ii) A resident with pressure ulcers receives necessary treatment 
and services, consistent with professional standards of practice, to 
promote healing, prevent infection and prevent new ulcers from 
developing.
    (2) Foot care. To ensure that residents receive proper treatment and 
care to maintain mobility and good foot health, the facility must--
    (i) Provide foot care and treatment, in accordance with professional 
standards of practice, including to prevent complications from the 
resident's medical condition(s) and
    (ii) If necessary, assist the resident in making appointments with a 
qualified person, and arranging for transportation to and from such 
appointments.
    (c) Mobility. (1) The facility must ensure that a resident who 
enters the facility without limited range of motion does not experience 
reduction in range of motion unless the resident's clinical condition 
demonstrates that a reduction in range of motion is unavoidable; and
    (2) A resident with limited range of motion receives appropriate 
treatment and services to increase range of motion and/or to prevent 
further decrease in range of motion.
    (3) A resident with limited mobility receives appropriate services, 
equipment, and assistance to maintain or improve mobility with the 
maximum practicable independence unless a reduction in mobility is 
demonstrably unavoidable.
    (d) Accidents.The facility must ensure that--
    (1) The resident environment remains as free of accident hazards as 
is possible; and
    (2) Each resident receives adequate supervision and assistance 
devices to prevent accidents.
    (e) Incontinence. (1) The facility must ensure that a resident who 
is continent of bladder and bowel on admission receives services and 
assistance to maintain continence unless his or her clinical condition 
is or becomes such that continence is not possible to maintain.
    (2) For a resident with urinary incontinence, based on the 
resident's comprehensive assessment, the facility must ensure that--
    (i) A resident who enters the facility without an indwelling 
catheter is not catheterized unless the resident's clinical condition 
demonstrates that catheterization was necessary;

[[Page 80]]

    (ii) A resident who enters the facility with an indwelling catheter 
or subsequently receives one is assessed for removal of the catheter as 
soon as possible unless the resident's clinical condition demonstrates 
that catheterization is necessary, and
    (iii) A resident who is incontinent of bladder receives appropriate 
treatment and services to prevent urinary tract infections and to 
restore continence to the extent possible.
    (3) For a resident with fecal incontinence, based on the resident's 
comprehensive assessment, the facility must ensure that a resident who 
is incontinent of bowel receives appropriate treatment and services to 
restore as much normal bowel function as possible.
    (f) Colostomy, urostomy, or ileostomy care. The facility must ensure 
that residents who require colostomy, urostomy, or ileostomy services, 
receive such care consistent with professional standards of practice, 
the comprehensive person-centered care plan, and the residents' goals 
and preferences.
    (g) Assisted nutrition and hydration. (Includes naso-gastric and 
gastrostomy tubes, both percutaneous endoscopic gastrostomy and 
percutaneous endoscopic jejunostomy, and enteral fluids). Based on a 
resident's comprehensive assessment, the facility must ensure that a 
resident--
    (1) Maintains acceptable parameters of nutritional status, such as 
usual body weight or desirable body weight range and electrolyte 
balance, unless the resident's clinical condition demonstrates that this 
is not possible or resident preferences indicate otherwise;
    (2) Is offered sufficient fluid intake to maintain proper hydration 
and health; and
    (3) Is offered a therapeutic diet when there is a nutritional 
problem and the health care provider orders a therapeutic diet.
    (4) A resident who has been able to eat enough alone or with 
assistance is not fed by enteral methods unless the resident's clinical 
condition demonstrates that enteral feeding was clinically indicated and 
consented to by the resident; and
    (5) A resident who is fed by enteral means receives the appropriate 
treatment and services to restore, if possible, oral eating skills and 
to prevent complications of enteral feeding including but not limited to 
aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic 
abnormalities, and nasal-pharyngeal ulcers.
    (h) Parenteral fluids. Parenteral fluids must be administered 
consistent with professional standards of practice and in accordance 
with physician orders, the comprehensive person-centered care plan, and 
the resident's goals and preferences.
    (i) Respiratory care, including tracheostomy care and tracheal 
suctioning. The facility must ensure that a resident who needs 
respiratory care, including tracheostomy care and tracheal suctioning, 
is provided such care, consistent with professional standards of 
practice, the comprehensive person-centered care plan, the residents' 
goals and preferences, and Sec. 483.65 of this subpart.
    (j) Prostheses. The facility must ensure that a resident who has a 
prosthesis is provided care and assistance, consistent with professional 
standards of practice, the comprehensive person-centered care plan, and 
the residents' goals and preferences, to wear and be able to use the 
prosthetic device.
    (k) Pain management. The facility must ensure that pain management 
is provided to residents who require such services, consistent with 
professional standards of practice, the comprehensive person-centered 
care plan, and the residents' goals and preferences.
    (l) Dialysis. The facility must ensure that residents who require 
dialysis receive such services, consistent with professional standards 
of practice, the comprehensive person-centered care plan, and the 
residents' goals and preferences.
    (m) Trauma-informed care. The facility must ensure that residents 
who are trauma survivors receive culturally-competent, trauma-informed 
care in accordance with professional standards of practice and 
accounting for residents' experiences and preferences in order to 
eliminate or mitigate triggers that may cause re-traumatization of the 
resident.

[[Page 81]]

    (n) Bed rails. The facility must attempt to use appropriate 
alternatives prior to installing a side or bed rail. If a bed or side 
rail is used, the facility must ensure correct installation, use, and 
maintenance of bed rails, including but not limited to the following 
elements.
    (1) Assess the resident for risk of entrapment from bed rails prior 
to installation.
    (2) Review the risks and benefits of bed rails with the resident or 
resident representative and obtain informed consent prior to 
installation.
    (3) Ensure that the bed's dimensions are appropriate for the 
resident's size and weight.
    (4) Follow the manufacturers' recommendations and specifications for 
installing and maintaining bed rails.

[81 FR 68860, Oct. 4, 2016]



Sec. 483.30  Physician services.

    A physician must personally approve in writing a recommendation that 
an individual be admitted to a facility. Each resident must remain under 
the care of a physician. A physician, physician assistant, nurse 
practitioner, or clinical nurse specialist must provide orders for the 
resident's immediate care and needs.
    (a) Physician supervision. The facility must ensure that--
    (1) The medical care of each resident is supervised by a physician; 
and
    (2) Another physician supervises the medical care of residents when 
their attending physician is unavailable.
    (b) Physician visits. The physician must--
    (1) Review the resident's total program of care, including 
medications and treatments, at each visit required by paragraph (c) of 
this section;
    (2) Write, sign, and date progress notes at each visit; and
    (3) Sign and date all orders with the exception of influenza and 
pneumococcal vaccines, which may be administered per physician-approved 
facility policy after an assessment for contraindications.
    (c) Frequency of physician visits. (1) The resident must be seen by 
a physician at least once every 30 days for the first 90 days after 
admission, and at least once every 60 days thereafter.
    (2) A physician visit is considered timely if it occurs not later 
than 10 days after the date the visit was required.
    (3) Except as provided in paragraphs (c)(4) and (f) of this section, 
all required physician visits must be made by the physician personally.
    (4) At the option of the physician, required visits in SNFs after 
the initial visit may alternate between personal visits by the physician 
and visits by a physician assistant, nurse practitioner, or clinical 
nurse specialist in accordance with paragraph (e) of this section.
    (d) Availability of physicians for emergency care. The facility must 
provide or arrange for the provision of physician services 24 hours a 
day, in case of an emergency.
    (e) Physician delegation of tasks in SNFs. (1) Except as specified 
in paragraph (e)(4) of this section, a physician may delegate tasks to a 
physician assistant, nurse practitioner, or clinical nurse specialist 
who--
    (i) Meets the applicable definition in Sec. 491.2 of this chapter 
or, in the case of a clinical nurse specialist, is licensed as such by 
the State;
    (ii) Is acting within the scope of practice as defined by State law; 
and
    (iii) Is under the supervision of the physician.
    (2) A resident's attending physician may delegate the task of 
writing dietary orders, consistent with Sec. 483.60, to a qualified 
dietitian or other clinically qualified nutrition professional who--
    (i) Is acting within the scope of practice as defined by State law; 
and
    (ii) Is under the supervision of the physician.
    (3) A resident's attending physician may delegate the task of 
writing therapy orders, consistent with Sec. 483.65, to a qualified 
therapist who--
    (i) Is acting within the scope of practice as defined by State law; 
and
    (ii) Is under the supervision of the physician.
    (4) A physician may not delegate a task when the regulations specify 
that the physician must perform it personally, or when the delegation is 
prohibited under State law or by the facility's own policies.

[[Page 82]]

    (f) Performance of physician tasks in NFs. At the option of the 
State, any required physician task in a NF (including tasks which the 
regulations specify must be performed personally by the physician) may 
also be satisfied when performed by a nurse practitioner, clinical nurse 
specialist, or physician assistant who is not an employee of the 
facility but who is working in collaboration with a physician.

[56 FR 48875, Sept. 26, 1991, as amended at 67 FR 61814, Oct. 2, 2002. 
Redesignated and amended at 81 FR 68861, Oct. 4, 2016]



Sec. 483.35  Nursing services.

    The facility must have sufficient nursing staff with the appropriate 
competencies and skills sets to provide nursing and related services to 
assure resident safety and attain or maintain the highest practicable 
physical, mental, and psychosocial well-being of each resident, as 
determined by resident assessments and individual plans of care and 
considering the number, acuity and diagnoses of the facility's resident 
population in accordance with the facility assessment required at Sec. 
483.70(e).
    (a) Sufficient staff. (1) The facility must provide services by 
sufficient numbers of each of the following types of personnel on a 24-
hour basis to provide nursing care to all residents in accordance with 
resident care plans:
    (i) Except when waived under paragraph (e) of this section, licensed 
nurses; and
    (ii) Other nursing personnel, including but not limited to nurse 
aides.
    (2) Except when waived under paragraph (c) of this section, the 
facility must designate a licensed nurse to serve as a charge nurse on 
each tour of duty.
    (3) The facility must ensure that licensed nurses have the specific 
competencies and skill sets necessary to care for residents' needs, as 
identified through resident assessments, and described in the plan of 
care.
    (4) Providing care includes but is not limited to assessing, 
evaluating, planning and implementing resident care plans and responding 
to resident's needs.
    (b) Registered nurse. (1) Except when waived under paragraph (e) or 
(f) of this section, the facility must use the services of a registered 
nurse for at least 8 consecutive hours a day, 7 days a week.
    (2) Except when waived under paragraph (e) or (f) of this section, 
the facility must designate a registered nurse to serve as the director 
of nursing on a full time basis.
    (3) The director of nursing may serve as a charge nurse only when 
the facility has an average daily occupancy of 60 or fewer residents.
    (c) Proficiency of nurse aides. The facility must ensure that nurse 
aides are able to demonstrate competency in skills and techniques 
necessary to care for residents' needs, as identified through resident 
assessments, and described in the plan of care.
    (d) Requirements for facility hiring and use of nursing aides--(1) 
General rule. A facility must not use any individual working in the 
facility as a nurse aide for more than 4 months, on a full-time basis, 
unless--
    (i) That individual is competent to provide nursing and nursing 
related services; and
    (ii)(A) That individual has completed a training and competency 
evaluation program, or a competency evaluation program approved by the 
State as meeting the requirements of Sec. Sec. 483.151 through 483.154; 
or
    (B) That individual has been deemed or determined competent as 
provided in Sec. 483.150(a) and (b).
    (2) Non-permanent employees. A facility must not use on a temporary, 
per diem, leased, or any basis other than a permanent employee any 
individual who does not meet the requirements in paragraphs (d)(1) (i) 
and (ii) of this section.
    (3) Minimum competency. A facility must not use any individual who 
has worked less than 4 months as a nurse aide in that facility unless 
the individual--
    (i) Is a full-time employee in a State-approved training and 
competency evaluation program;
    (ii) Has demonstrated competence through satisfactory participation 
in a State-approved nurse aide training and competency evaluation 
program or competency evaluation program; or

[[Page 83]]

    (iii) Has been deemed or determined competent as provided in Sec. 
483.150(a) and (b).
    (4) Registry verification. Before allowing an individual to serve as 
a nurse aide, a facility must receive registry verification that the 
individual has met competency evaluation requirements unless--
    (i) The individual is a full-time employee in a training and 
competency evaluation program approved by the State; or
    (ii) The individual can prove that he or she has recently 
successfully completed a training and competency evaluation program or 
competency evaluation program approved by the State and has not yet been 
included in the registry. Facilities must follow up to ensure that such 
an individual actually becomes registered.
    (5) Multi-State registry verification. Before allowing an individual 
to serve as a nurse aide, a facility must seek information from every 
State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A) 
of the Act that the facility believes will include information on the 
individual.
    (6) Required retraining. If, since an individual's most recent 
completion of a training and competency evaluation program, there has 
been a continuous period of 24 consecutive months during none of which 
the individual provided nursing or nursing-related services for monetary 
compensation, the individual must complete a new training and competency 
evaluation program or a new competency evaluation program.
    (7) Regular in-service education. The facility must complete a 
performance review of every nurse aide at least once every 12 months, 
and must provide regular in-service education based on the outcome of 
these reviews. In-service training must comply with the requirements of 
Sec. 483.95(g).
    (e) Nursing facilities: Waiver of requirement to provide licensed 
nurses on a 24-hour basis. To the extent that a facility is unable to 
meet the requirements of paragraphs (a)(2) and (b)(1) of this section, a 
State may waive such requirements with respect to the facility if--
    (1) The facility demonstrates to the satisfaction of the State that 
the facility has been unable, despite diligent efforts (including 
offering wages at the community prevailing rate for nursing facilities), 
to recruit appropriate personnel;
    (2) The State determines that a waiver of the requirement will not 
endanger the health or safety of individuals staying in the facility;
    (3) The State finds that, for any periods in which licensed nursing 
services are not available, a registered nurse or a physician is 
obligated to respond immediately to telephone calls from the facility;
    (4) A waiver granted under the conditions listed in paragraph (c) of 
this section is subject to annual State review;
    (5) In granting or renewing a waiver, a facility may be required by 
the State to use other qualified, licensed personnel;
    (6) The State agency granting a waiver of such requirements provides 
notice of the waiver to the Office of the State Long-Term Care Ombudsman 
(established under section 712 of the Older Americans Act of 1965) and 
the protection and advocacy system in the State for individuals with a 
mental disorder who are eligible for such services as provided by the 
protection and advocacy agency; and
    (7) The nursing facility that is granted such a waiver by a State 
notifies residents of the facility and their resident representatives of 
the waiver.
    (f) SNFs: Waiver of the requirement to provide services of a 
registered nurse for more than 40 hours a week. (1) The Secretary may 
waive the requirement that a SNF provide the services of a registered 
nurse for more than 40 hours a week, including a director of nursing 
specified in paragraph (b) of this section, if the Secretary finds 
that--
    (i) The facility is located in a rural area and the supply of 
skilled nursing facility services in the area is not sufficient to meet 
the needs of individuals residing in the area;
    (ii) The facility has one full-time registered nurse who is 
regularly on duty at the facility 40 hours a week; and
    (iii) The facility either--
    (A) Has only patients whose physicians have indicated (through 
physicians' orders or admission notes) that they do not require the 
services of a

[[Page 84]]

registered nurse or a physician for a 48-hours period, or
    (B) Has made arrangements for a registered nurse or a physician to 
spend time at the facility, as determined necessary by the physician, to 
provide necessary skilled nursing services on days when the regular 
full-time registered nurse is not on duty;
    (iv) The Secretary provides notice of the waiver to the Office of 
the State Long-Term Care Ombudsman (established under section 712 of the 
Older Americans Act of 1965) and the protection and advocacy system in 
the State for individuals with developmental disabilities or mental 
disorders; and
    (v) The facility that is granted such a waiver notifies residents of 
the facility and their resident representatives of the waiver.
    (2) A waiver of the registered nurse requirement under paragraph 
(d)(1) of this section is subject to annual renewal by the Secretary.
    (g) Nurse staffing information--(1) Data requirements. The facility 
must post the following information on a daily basis:
    (i) Facility name.
    (ii) The current date.
    (iii) The total number and the actual hours worked by the following 
categories of licensed and unlicensed nursing staff directly responsible 
for resident care per shift:
    (A) Registered nurses.
    (B) Licensed practical nurses or licensed vocational nurses (as 
defined under State law).
    (C) Certified nurse aides.
    (iv) Resident census.
    (2) Posting requirements. (i) The facility must post the nurse 
staffing data specified in paragraph (e)(1) of this section on a daily 
basis at the beginning of each shift.
    (ii) Data must be posted as follows:
    (A) Clear and readable format.
    (B) In a prominent place readily accessible to residents and 
visitors.
    (3) Public access to posted nurse staffing data. The facility must, 
upon oral or written request, make nurse staffing data available to the 
public for review at a cost not to exceed the community standard.
    (4) Facility data retention requirements. The facility must maintain 
the posted daily nurse staffing data for a minimum of 18 months, or as 
required by State law, whichever is greater.

[56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992; 
70 FR 62073, Oct. 28, 2005. Redesignated and amended at 81 FR 68861, 
Oct. 4, 2016]



Sec. 483.40  Behavioral health services.

    Each resident must receive and the facility must provide the 
necessary behavioral health care and services to attain or maintain the 
highest practicable physical, mental, and psychosocial well-being, in 
accordance with the comprehensive assessment and plan of care. 
Behavioral health encompasses a resident's whole emotional and mental 
well-being, which includes, but is not limited to, the prevention and 
treatment of mental and substance use disorders.
    (a) The facility must have sufficient staff who provide direct 
services to residents with the appropriate competencies and skills sets 
to provide nursing and related services to assure resident safety and 
attain or maintain the highest practicable physical, mental and 
psychosocial well-being of each resident, as determined by resident 
assessments and individual plans of care and considering the number, 
acuity and diagnoses of the facility's resident population in accordance 
with Sec. 483.70(e). These competencies and skills sets include, but 
are not limited to, knowledge of and appropriate training and 
supervision for:
    (1) Caring for residents with mental and psychosocial disorders, as 
well as residents with a history of trauma and/or post-traumatic stress 
disorder, that have been identified in the facility assessment conducted 
pursuant to Sec. 483.70(e), and
    (2) Implementing non-pharmacological interventions.
    (b) Based on the comprehensive assessment of a resident, the 
facility must ensure that--
    (1) A resident who displays or is diagnosed with mental disorder or 
psychosocial adjustment difficulty, or who has a history of trauma and/
or post-traumatic stress disorder, receives appropriate treatment and 
services to correct the assessed problem or to attain the highest 
practicable mental and psychosocial well-being;

[[Page 85]]

    (2) A resident whose assessment did not reveal or who does not have 
a diagnosis of a mental or psychosocial adjustment difficulty or a 
documented history of trauma and/or post-traumatic stress disorder does 
not display a pattern of decreased social interaction and/or increased 
withdrawn, angry, or depressive behaviors, unless the resident's 
clinical condition demonstrates that development of such a pattern was 
unavoidable; and
    (3) A resident who displays or is diagnosed with dementia, receives 
the appropriate treatment and services to attain or maintain his or her 
highest practicable physical, mental, and psychosocial well-being.
    (c) If rehabilitative services such as but not limited to physical 
therapy, speech-language pathology, occupational therapy, and 
rehabilitative services for mental disorders and intellectual 
disability, are required in the resident's comprehensive plan of care, 
the facility must--
    (1) Provide the required services, including specialized 
rehabilitation services as required in Sec. 483.65; or
    (2) Obtain the required services from an outside resource (in 
accordance with Sec. 483.70(g) of this part) from a Medicare and/or 
Medicaid provider of specialized rehabilitative services.
    (d) The facility must provide medically-related social services to 
attain or maintain the highest practicable physical, mental and 
psychosocial well-being of each resident.

[81 FR 68862, Oct. 4, 2016]



Sec. 483.45  Pharmacy services.

    The facility must provide routine and emergency drugs and 
biologicals to its residents, or obtain them under an agreement 
described in Sec. 483.70(g). The facility may permit unlicensed 
personnel to administer drugs if State law permits, but only under the 
general supervision of a licensed nurse.
    (a) Procedures. A facility must provide pharmaceutical services 
(including procedures that assure the accurate acquiring, receiving, 
dispensing, and administering of all drugs and biologicals) to meet the 
needs of each resident.
    (b) Service consultation. The facility must employ or obtain the 
services of a licensed pharmacist who--
    (1) Provides consultation on all aspects of the provision of 
pharmacy services in the facility;
    (2) Establishes a system of records of receipt and disposition of 
all controlled drugs in sufficient detail to enable an accurate 
reconciliation; and
    (3) Determines that drug records are in order and that an account of 
all controlled drugs is maintained and periodically reconciled.
    (c) Drug regimen review. (1) The drug regimen of each resident must 
be reviewed at least once a month by a licensed pharmacist.
    (2) This review must include a review of the resident's medical 
chart.
    (3) A psychotropic drug is any drug that affects brain activities 
associated with mental processes and behavior. These drugs include, but 
are not limited to, drugs in the following categories:
    (i) Anti-psychotic;
    (ii) Anti-depressant;
    (iii) Anti-anxiety; and
    (iv) Hypnotic.
    (4) The pharmacist must report any irregularities to the attending 
physician and the facility's medical director and director of nursing, 
and these reports must be acted upon.
    (i) Irregularities include, but are not limited to, any drug that 
meets the criteria set forth in paragraph (d) of this section for an 
unnecessary drug.
    (ii) Any irregularities noted by the pharmacist during this review 
must be documented on a separate, written report that is sent to the 
attending physician and the facility's medical director and director of 
nursing and lists, at a minimum, the resident's name, the relevant drug, 
and the irregularity the pharmacist identified.
    (iii) The attending physician must document in the resident's 
medical record that the identified irregularity has been reviewed and 
what, if any, action has been taken to address it. If there is to be no 
change in the medication, the attending physician should document his or 
her rationale in the resident's medical record.
    (5) The facility must develop and maintain policies and procedures 
for

[[Page 86]]

the monthly drug regimen review that include, but are not limited to, 
time frames for the different steps in the process and steps the 
pharmacist must take when he or she identifies an irregularity that 
requires urgent action to protect the resident.
    (d) Unnecessary drugs--General. Each resident's drug regimen must be 
free from unnecessary drugs. An unnecessary drug is any drug when used--
    (1) In excessive dose (including duplicate drug therapy); or
    (2) For excessive duration; or
    (3) Without adequate monitoring; or
    (4) Without adequate indications for its use; or
    (5) In the presence of adverse consequences which indicate the dose 
should be reduced or discontinued; or
    (6) Any combinations of the reasons stated in paragraphs (d)(1) 
through (5) of this section.
    (e) Psychotropic drugs. Based on a comprehensive assessment of a 
resident, the facility must ensure that--
    (1) Residents who have not used psychotropic drugs are not given 
these drugs unless the medication is necessary to treat a specific 
condition as diagnosed and documented in the clinical record;
    (2) Residents who use psychotropic drugs receive gradual dose 
reductions, and behavioral interventions, unless clinically 
contraindicated, in an effort to discontinue these drugs;
    (3) Residents do not receive psychotropic drugs pursuant to a PRN 
order unless that medication is necessary to treat a diagnosed specific 
condition that is documented in the clinical record; and
    (4) PRN orders for psychotropic drugs are limited to 14 days. Except 
as provided in Sec. 483.45(e)(5), if the attending physician or 
prescribing practitioner believes that it is appropriate for the PRN 
order to be extended beyond 14 days, he or she should document their 
rationale in the resident's medical record and indicate the duration for 
the PRN order.
    (5) PRN orders for anti-psychotic drugs are limited to 14 days and 
cannot be renewed unless the attending physician or prescribing 
practitioner evaluates the resident for the appropriateness of that 
medication.
    (f) Medication errors. The facility must ensure that its--
    (1) Medication error rates are not 5 percent or greater; and
    (2) Residents are free of any significant medication errors.
    (g) Labeling of drugs and biologicals. Drugs and biologicals used in 
the facility must be labeled in accordance with currently accepted 
professional principles, and include the appropriate accessory and 
cautionary instructions, and the expiration date when applicable.
    (h) Storage of drugs and biologicals. (1) In accordance with State 
and Federal laws, the facility must store all drugs and biologicals in 
locked compartments under proper temperature controls, and permit only 
authorized personnel to have access to the keys.
    (2) The facility must provide separately locked, permanently affixed 
compartments for storage of controlled drugs listed in Schedule II of 
the Comprehensive Drug Abuse Prevention and Control Act of 1976 and 
other drugs subject to abuse, except when the facility uses single unit 
package drug distribution systems in which the quantity stored is 
minimal and a missing dose can be readily detected.

[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992. 
Redesignated and amended at 81 FR 68861, 68863, Oct. 4, 2016; 82 FR 
32259, July 13, 2017]



Sec. 483.50  Laboratory, radiology, and other diagnostic services.

    (a) Laboratory services. (1) The facility must provide or obtain 
laboratory services to meet the needs of its residents. The facility is 
responsible for the quality and timeliness of the services.
    (i) If the facility provides its own laboratory services, the 
services must meet the applicable requirements for laboratories 
specified in part 493 of this chapter.
    (ii) If the facility provides blood bank and transfusion services, 
it must meet the applicable requirements for laboratories specified in 
part 493 of this chapter.
    (iii) If the laboratory chooses to refer specimens for testing to 
another laboratory, the referral laboratory must be certified in the 
appropriate specialties and subspecialties of services in

[[Page 87]]

accordance with the requirements of part 493 of this chapter.
    (iv) If the facility does not provide laboratory services on site, 
it must have an agreement to obtain these services from a laboratory 
that meets the applicable requirements of part 493 of this chapter.
    (2) The facility must:
    (i) Provide or obtain laboratory services only when ordered by a 
physician; physician assistant; nurse practitioner or clinical nurse 
specialist in accordance with State law, including scope of practice 
laws.
    (ii) Promptly notify the ordering physician, physician assistant, 
nurse practitioner, or clinical nurse specialist of laboratory results 
that fall outside of clinical reference ranges in accordance with 
facility policies and procedures for notification of a practitioner or 
per the ordering physician's orders.
    (iii) Assist the resident in making transportation arrangements to 
and from the source of service, if the resident needs assistance; and
    (iv) File in the resident's clinical record laboratory reports that 
are dated and contain the name and address of the testing laboratory.
    (b) Radiology and other diagnostic services. (1) The facility must 
provide or obtain radiology and other diagnostic services to meet the 
needs of its residents. The facility is responsible for the quality and 
timeliness of the services.
    (i) If the facility provides its own diagnostic services, the 
services must meet the applicable conditions of participation for 
hospitals contained in Sec. 482.26 of this subchapter.
    (ii) If the facility does not provide its own diagnostic services, 
it must have an agreement to obtain these services from a provider or 
supplier that is approved to provide these services under Medicare.
    (2) The facility must:
    (i) Provide or obtain radiology and other diagnostic services only 
when ordered by a physician; physician assistant; nurse practitioner or 
clinical nurse specialist in accordance with State law, including scope 
of practice laws.
    (ii) Promptly notify the ordering physician, physician assistant, 
nurse practitioner, or clinical nurse specialist of results that fall 
outside of clinical reference ranges in accordance with facility 
policies and procedures for notification of a practitioner or per the 
ordering physician's orders.
    (iii) Assist the resident in making transportation arrangements to 
and from the source of service, if the resident needs assistance; and
    (iv) File in the resident's clinical record signed and dated reports 
of x-ray and other diagnostic services.

[81 FR 68863, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.55  Dental services.

    The facility must assist residents in obtaining routine and 24-hour 
emergency dental care.
    (a) Skilled nursing facilities. A facility (1) Must provide or 
obtain from an outside resource, in accordance with Sec. 483.70(g), 
routine and emergency dental services to meet the needs of each 
resident;
    (2) May charge a Medicare resident an additional amount for routine 
and emergency dental services;
    (3) Must have a policy identifying those circumstances when the loss 
or damage of dentures is the facility's responsibility and may not 
charge a resident for the loss or damage of dentures determined in 
accordance with facility policy to be the facility's responsibility;
    (4) Must if necessary or if requested, assist the resident--
    (i) In making appointments; and
    (ii) By arranging for transportation to and from the dental services 
location; and
    (5) Must promptly, within 3 days, refer residents with lost or 
damaged dentures for dental services. If a referral does not occur 
within 3 days, the facility must provide documentation of what they did 
to ensure the resident could still eat and drink adequately while 
awaiting dental services and the extenuating circumstances that led to 
the delay.
    (b) Nursing facilities. The facility (1) Must provide or obtain from 
an outside resource, in accordance with Sec. 483.70(g),

[[Page 88]]

the following dental services to meet the needs of each resident:
    (i) Routine dental services (to the extent covered under the State 
plan); and
    (ii) Emergency dental services;
    (2) Must, if necessary or if requested, assist the resident--
    (i) In making appointments; and
    (ii) By arranging for transportation to and from the dental services 
locations;
    (3) Must promptly, within 3 days, refer residents with lost or 
damaged dentures for dental services. If a referral does not occur 
within 3 days, the facility must provide documentation of what they did 
to ensure the resident could still eat and drink adequately while 
awaiting dental services and the extenuating circumstances that led to 
the delay;
    (4) Must have a policy identifying those circumstances when the loss 
or damage of dentures is the facility's responsibility and may not 
charge a resident for the loss or damage of dentures determined in 
accordance with facility policy to be the facility's responsibility; and
    (5) Must assist residents who are eligible and wish to participate 
to apply for reimbursement of dental services as an incurred medical 
expense under the State plan.

[56 FR 48875, Sept. 26, 1991, as amended at 81 FR 68864, Oct. 4, 2016]



Sec. 483.60  Food and nutrition services.

    The facility must provide each resident with a nourishing, 
palatable, well-balanced diet that meets his or her daily nutritional 
and special dietary needs, taking into consideration the preferences of 
each resident.
    (a) Staffing. The facility must employ sufficient staff with the 
appropriate competencies and skills sets to carry out the functions of 
the food and nutrition service, taking into consideration resident 
assessments, individual plans of care and the number, acuity and 
diagnoses of the facility's resident population in accordance with the 
facility assessment required at Sec. 483.70(e). This includes:
    (1) A qualified dietitian or other clinically qualified nutrition 
professional either full-time, part-time, or on a consultant basis. A 
qualified dietitian or other clinically qualified nutrition professional 
is one who--
    (i) Holds a bachelor's or higher degree granted by a regionally 
accredited college or university in the United States (or an equivalent 
foreign degree) with completion of the academic requirements of a 
program in nutrition or dietetics accredited by an appropriate national 
accreditation organization recognized for this purpose.
    (ii) Has completed at least 900 hours of supervised dietetics 
practice under the supervision of a registered dietitian or nutrition 
professional.
    (iii) Is licensed or certified as a dietitian or nutrition 
professional by the State in which the services are performed. In a 
state that does not provide for licensure or certification, the 
individual will be deemed to have met this requirement if he or she is 
recognized as a ``registered dietitian'' by the Commission on Dietetic 
Registration or its successor organization, or meets the requirements of 
paragraphs (a)(1)(i) and (ii) of this section.
    (iv) For dietitians hired or contracted with prior to November 28, 
2016, meets these requirements no later than 5 years after November 28, 
2016 or as required by state law.
    (2) If a qualified dietitian or other clinically qualified nutrition 
professional is not employed full-time, the facility must designate a 
person to serve as the director of food and nutrition services who--
    (i) For designations prior to November 28, 2016, meets the following 
requirements no later than 5 years after November 28, 2016, or no later 
than 1 year after November 28, 2016 for designations after November 28, 
2016, is:
    (A) A certified dietary manager; or
    (B) A certified food service manager, or
    (C) Has similar national certification for food service management 
and safety from a national certifying body; or
    (D) Has an associate's or higher degree in food service management 
or in hospitality, if the course study includes food service or 
restaurant management, from an accredited institution of higher 
learning; and
    (ii) In States that have established standards for food service 
managers or

[[Page 89]]

dietary managers, meets State requirements for food service managers or 
dietary managers, and
    (iii) Receives frequently scheduled consultations from a qualified 
dietitian or other clinically qualified nutrition professional.
    (3) Support staff. The facility must provide sufficient support 
personnel to safely and effectively carry out the functions of the food 
and nutrition service.
    (b) A member of the Food and Nutrition Services staff must 
participate on the interdisciplinary team as required in Sec. 
483.21(b)(2)(ii).
    (c) Menus and nutritional adequacy. Menus must--
    (1) Meet the nutritional needs of residents in accordance with 
established national guidelines.;
    (2) Be prepared in advance;
    (3) Be followed;
    (4) Reflect, based on a facility's reasonable efforts, the 
religious, cultural, and ethnic needs of the resident population, as 
well as input received from residents and resident groups;
    (5) Be updated periodically;
    (6) Be reviewed by the facility's dietitian or other clinically 
qualified nutrition professional for nutritional adequacy; and
    (7) Nothing in this paragraph should be construed to limit the 
resident's right to make personal dietary choices.
    (d) Food and drink. Each resident receives and the facility 
provides--
    (1) Food prepared by methods that conserve nutritive value, flavor, 
and appearance;
    (2) Food and drink that is palatable, attractive, and at a safe and 
appetizing temperature;
    (3) Food prepared in a form designed to meet individual needs;
    (4) Food that accommodates resident allergies, intolerances, and 
preferences;
    (5) Appealing options of similar nutritive value to residents who 
choose not to eat food that is initially served or who request a 
different meal choice; and
    (6) Drinks, including water and other liquids consistent with 
resident needs and preferences and sufficient to maintain resident 
hydration.
    (e) Therapeutic diets. (1) Therapeutic diets must be prescribed by 
the attending physician.
    (2) The attending physician may delegate to a registered or licensed 
dietitian the task of prescribing a resident's diet, including a 
therapeutic diet, to the extent allowed by State law.
    (f) Frequency of meals. (1) Each resident must receive and the 
facility must provide at least three meals daily, at regular times 
comparable to normal mealtimes in the community or in accordance with 
resident needs, preferences, requests, and plan of care.
    (2) There must be no more than 14 hours between a substantial 
evening meal and breakfast the following day, except when a nourishing 
snack is served at bedtime, up to 16 hours may elapse between a 
substantial evening meal and breakfast the following day if a resident 
group agrees to this meal span.
    (3) Suitable, nourishing alternative meals and snacks must be 
provided to residents who want to eat at non-traditional times or 
outside of scheduled meal service times, consistent with the resident 
plan of care.
    (g) Assistive devices. The facility must provide special eating 
equipment and utensils for residents who need them and appropriate 
assistance to ensure that the resident can use the assistive devices 
when consuming meals and snacks.
    (h) Paid feeding assistants--(1) State-approved training course. A 
facility may use a paid feeding assistant, as defined in Sec. 488.301 
of this chapter, if--
    (i) The feeding assistant has successfully completed a State-
approved training course that meets the requirements of Sec. 483.160 
before feeding residents; and
    (ii) The use of feeding assistants is consistent with State law.
    (2) Supervision. (i) A feeding assistant must work under the 
supervision of a registered nurse (RN) or licensed practical nurse 
(LPN).
    (ii) In an emergency, a feeding assistant must call a supervisory 
nurse for help.
    (3) Resident selection criteria. (i) A facility must ensure that a 
feeding assistant provides dining assistance only

[[Page 90]]

for residents who have no complicated feeding problems.
    (ii) Complicated feeding problems include, but are not limited to, 
difficulty swallowing, recurrent lung aspirations, and tube or 
parenteral/IV feedings.
    (iii) The facility must base resident selection on the 
interdisciplinary team's assessment and the resident's latest assessment 
and plan of care. Appropriateness for this program should be reflected 
in the comprehensive care plan.
    (i) Food safety requirements. The facility must--
    (1) Procure food from sources approved or considered satisfactory by 
federal, state, or local authorities;
    (i) This may include food items obtained directly from local 
producers, subject to applicable State and local laws or regulations.
    (ii) This provision does not prohibit or prevent facilities from 
using produce grown in facility gardens, subject to compliance with 
applicable safe growing and food-handling practices.
    (iii) This provision does not preclude residents from consuming 
foods not procured by the facility.
    (2) Store, prepare, distribute, and serve food in accordance with 
professional standards for food service safety.
    (3) Have a policy regarding use and storage of foods brought to 
residents by family and other visitors to ensure safe and sanitary 
storage, handling, and consumption, and
    (4) Dispose of garbage and refuse properly.

[81 FR 68864, Oct. 4, 2016]



Sec. 483.65  Specialized rehabilitative services.

    (a) Provision of services. If specialized rehabilitative services 
such as but not limited to physical therapy, speech-language pathology, 
occupational therapy, respiratory therapy, and rehabilitative services 
for a mental disorder and intellectual disability or services of a 
lesser intensity as set forth at Sec. 483.120(c), are required in the 
resident's comprehensive plan of care, the facility must--
    (1) Provide the required services; or
    (2) In accordance with Sec. 483.70(g), obtain the required services 
from an outside resource that is a provider of specialized 
rehabilitative services and is not excluded from participating in any 
federal or state health care programs pursuant to section 1128 and 1156 
of the Act.
    (b) Qualifications. Specialized rehabilitative services must be 
provided under the written order of a physician by qualified personnel.

[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992. 
Redesignated and amended at 81 FR 68861, 68865, Oct. 4, 2016]



Sec. 483.70  Administration.

    A facility must be administered in a manner that enables it to use 
its resources effectively and efficiently to attain or maintain the 
highest practicable physical, mental, and psychosocial well-being of 
each resident.
    (a) Licensure. A facility must be licensed under applicable State 
and local law.
    (b) Compliance with Federal, State, and local laws and professional 
standards. The facility must operate and provide services in compliance 
with all applicable Federal, State, and local laws, regulations, and 
codes, and with accepted professional standards and principles that 
apply to professionals providing services in such a facility.
    (c) Relationship to other HHS regulations. In addition to compliance 
with the regulations set forth in this subpart, facilities are obliged 
to meet the applicable provisions of other HHS regulations, including 
but not limited to those pertaining to nondiscrimination on the basis of 
race, color, or national origin (45 CFR part 80); nondiscrimination on 
the basis of disability (45 CFR part 84); nondiscrimination on the basis 
of age (45 CFR part 91); nondiscrimination on the basis of race, color, 
national origin, sex, age, or disability (45 CFR part 92); protection of 
human subjects of research (45 CFR part 46); and fraud and abuse (42 CFR 
part 455) and protection of individually identifiable health information 
(45 CFR parts 160 and 164). Violations of such other provisions may 
result in a finding of non-compliance with this paragraph.
    (d) Governing body. (1) The facility must have a governing body, or 
designated persons functioning as a governing body, that is legally 
responsible

[[Page 91]]

for establishing and implementing policies regarding the management and 
operation of the facility; and
    (2) The governing body appoints the administrator who is--
    (i) Licensed by the State, where licensing is required;
    (ii) Responsible for management of the facility; and
    (iii) Reports to and is accountable to the governing body.
    (3) The governing body is responsible and accountable for the QAPI 
program, in accordance with Sec. 483.75(f).
    (e) Facility assessment. The facility must conduct and document a 
facility-wide assessment to determine what resources are necessary to 
care for its residents competently during both day-to-day operations and 
emergencies. The facility must review and update that assessment, as 
necessary, and at least annually. The facility must also review and 
update this assessment whenever there is, or the facility plans for, any 
change that would require a substantial modification to any part of this 
assessment. The facility assessment must address or include:
    (1) The facility's resident population, including, but not limited 
to,
    (i) Both the number of residents and the facility's resident 
capacity;
    (ii) The care required by the resident population considering the 
types of diseases, conditions, physical and cognitive disabilities, 
overall acuity, and other pertinent facts that are present within that 
population;
    (iii) The staff competencies that are necessary to provide the level 
and types of care needed for the resident population;
    (iv) The physical environment, equipment, services, and other 
physical plant considerations that are necessary to care for this 
population; and
    (v) Any ethnic, cultural, or religious factors that may potentially 
affect the care provided by the facility, including, but not limited to, 
activities and food and nutrition services.
    (2) The facility's resources, including but not limited to,
    (i) All buildings and/or other physical structures and vehicles;
    (ii) Equipment (medical and non-medical);
    (iii) Services provided, such as physical therapy, pharmacy, and 
specific rehabilitation therapies;
    (iv) All personnel, including managers, staff (both employees and 
those who provide services under contract), and volunteers, as well as 
their education and/or training and any competencies related to resident 
care;
    (v) Contracts, memorandums of understanding, or other agreements 
with third parties to provide services or equipment to the facility 
during both normal operations and emergencies; and
    (vi) Health information technology resources, such as systems for 
electronically managing patient records and electronically sharing 
information with other organizations.
    (3) A facility-based and community-based risk assessment, utilizing 
an all-hazards approach.
    (f) Staff qualifications. (1) The facility must employ on a full-
time, part-time or consultant basis those professionals necessary to 
carry out the provisions of these requirements.
    (2) Professional staff must be licensed, certified, or registered in 
accordance with applicable State laws.
    (g) Use of outside resources. (1) If the facility does not employ a 
qualified professional person to furnish a specific service to be 
provided by the facility, the facility must have that service furnished 
to residents by a person or agency outside the facility under an 
arrangement described in section 1861(w) of the Act or (with respect to 
services furnished to NF residents and dental services furnished to SNF 
residents) an agreement described in paragraph (g)(2) of this section.
    (2) Arrangements as described in section 1861(w) of the Act or 
agreements pertaining to services furnished by outside resources must 
specify in writing that the facility assumes responsibility for--
    (i) Obtaining services that meet professional standards and 
principles that apply to professionals providing services in such a 
facility; and
    (ii) The timeliness of the services.
    (h) Medical director. (1) The facility must designate a physician to 
serve as medical director.

[[Page 92]]

    (2) The medical director is responsible for--
    (i) Implementation of resident care policies; and
    (ii) The coordination of medical care in the facility.
    (i) Medical records. (1) In accordance with accepted professional 
standards and practices, the facility must maintain medical records on 
each resident that are--
    (i) Complete;
    (ii) Accurately documented;
    (iii) Readily accessible; and
    (iv) Systematically organized.
    (2) The facility must keep confidential all information contained in 
the resident's records, regardless of the form or storage method of the 
records, except when release is--
    (i) To the individual, or their resident representative where 
permitted by applicable law;
    (ii) Required by law;
    (iii) For treatment, payment, or health care operations, as 
permitted by and in compliance with 45 CFR 164.506;
    (iv) For public health activities, reporting of abuse, neglect, or 
domestic violence, health oversight activities, judicial and 
administrative proceedings, law enforcement purposes, organ donation 
purposes, research purposes, or to coroners, medical examiners, funeral 
directors, and to avert a serious threat to health or safety as 
permitted by and in compliance with 45 CFR 164.512.
    (3) The facility must safeguard medical record information against 
loss, destruction, or unauthorized use;
    (4) Medical records must be retained for--
    (i) The period of time required by State law; or
    (ii) Five years from the date of discharge when there is no 
requirement in State law; or
    (iii) For a minor, 3 years after a resident reaches legal age under 
State law.
    (5) The medical record must contain--
    (i) Sufficient information to identify the resident;
    (ii) A record of the resident's assessments;
    (iii) The comprehensive plan of care and services provided;
    (iv) The results of any preadmission screening and resident review 
evaluations and determinations conducted by the State;
    (v) Physician's, nurse's, and other licensed professional's progress 
notes; and
    (vi) Laboratory, radiology and other diagnostic services reports as 
required under Sec. 483.50.
    (j) Transfer agreement. (1) In accordance with section 1861(l) of 
the Act, the facility (other than a nursing facility which is located in 
a State on an Indian reservation) must have in effect a written transfer 
agreement with one or more hospitals approved for participation under 
the Medicare and Medicaid programs that reasonably assures that--
    (i) Residents will be transferred from the facility to the hospital, 
and ensured of timely admission to the hospital when transfer is 
medically appropriate as determined by the attending physician or, in an 
emergency situation, by another practitioner in accordance with facility 
policy and consistent with state law; and
    (ii) Medical and other information needed for care and treatment of 
residents and, when the transferring facility deems it appropriate, for 
determining whether such residents can receive appropriate services or 
receive services in a less restrictive setting than either the facility 
or the hospital, or reintegrated into the community, will be exchanged 
between the providers, including but not limited to the information 
required under Sec. 483.15(c)(2)(iii).
    (2) The facility is considered to have a transfer agreement in 
effect if the facility has attempted in good faith to enter into an 
agreement with a hospital sufficiently close to the facility to make 
transfer feasible.
    (k) Disclosure of ownership. (1) The facility must comply with the 
disclosure requirements of Sec. Sec. 420.206 and 455.104 of this 
chapter.
    (2) The facility must provide written notice to the State agency 
responsible for licensing the facility at the time of change, if a 
change occurs in--
    (i) Persons with an ownership or control interest, as defined in 
Sec. Sec. 420.201 and 455.101 of this chapter;

[[Page 93]]

    (ii) The officers, directors, agents, or managing employees;
    (iii) The corporation, association, or other company responsible for 
the management of the facility; or
    (iv) The facility's administrator or director of nursing.
    (3) The notice specified in paragraph (k)(2) of this section must 
include the identity of each new individual or company.
    (l) Facility closure-Administrator. Any individual who is the 
administrator of the facility must:
    (1) Submit to the State Survey Agency, the State LTC ombudsman, 
residents of the facility, and the legal representatives of such 
residents or other responsible parties, written notification of an 
impending closure:
    (i) At least 60 days prior to the date of closure; or
    (ii) In the case of a facility where the Secretary or a State 
terminates the facility's participation in the Medicare and/or Medicaid 
programs, not later than the date that the Secretary determines 
appropriate;
    (2) Ensure that the facility does not admit any new residents on or 
after the date on which such written notification is submitted; and
    (3) Include in the notice the plan, that has been approved by the 
State, for the transfer and adequate relocation of the residents of the 
facility by a date that would be specified by the State prior to 
closure, including assurances that the residents would be transferred to 
the most appropriate facility or other setting in terms of quality, 
services, and location, taking into consideration the needs, choice, and 
best interests of each resident.
    (m) Facility closure. The facility must have in place policies and 
procedures to ensure that the administrator's duties and 
responsibilities involve providing the appropriate notices in the event 
of a facility closure, as required at paragraph (l) of this section.
    (n) Binding arbitration agreements. If a facility chooses to ask a 
resident or his or her representative to enter into an agreement for 
binding arbitration, the facility must comply with all of the 
requirements in this section.
    (1) The facility must not require any resident or his or her 
representative to sign an agreement for binding arbitration as a 
condition of admission to, or as a requirement to continue to receive 
care at, the facility and must explicitly inform the resident or his or 
her representative of his or her right not to sign the agreement as a 
condition of admission to, or as a requirement to continue to receive 
care at, the facility.
    (2) The facility must ensure that:
    (i) The agreement is explained to the resident and his or her 
representative in a form and manner that he or she understands, 
including in a language the resident and his or her representative 
understands;
    (ii) The resident or his or her representative acknowledges that he 
or she understands the agreement;
    (iii) The agreement provides for the selection of a neutral 
arbitrator agreed upon by both parties; and
    (iv) The agreement provides for the selection of a venue that is 
convenient to both parties.
    (3) The agreement must explicitly grant the resident or his or her 
representative the right to rescind the agreement within 30 calendar 
days of signing it.
    (4) The agreement must explicitly state that neither the resident 
nor his or her representative is required to sign an agreement for 
binding arbitration as a condition of admission to, or as a requirement 
to continue to receive care at, the facility.
    (5) The agreement may not contain any language that prohibits or 
discourages the resident or anyone else from communicating with federal, 
state, or local officials, including but not limited to, federal and 
state surveyors, other federal or state health department employees, and 
representatives of the Office of the State Long-Term Care Ombudsman, in 
accordance with Sec. 483.10(k).
    (6) When the facility and a resident resolve a dispute through 
arbitration, a copy of the signed agreement for binding arbitration and 
the arbitrator's final decision must be retained by the facility for 5 
years after the resolution of that dispute on and be available for 
inspection upon request by CMS or its designee.

[[Page 94]]

    (o) Hospice services. (1) A long-term care (LTC) facility may do 
either of the following:
    (i) Arrange for the provision of hospice services through an 
agreement with one or more Medicare-certified hospices.
    (ii) Not arrange for the provision of hospice services at the 
facility through an agreement with a Medicare-certified hospice and 
assist the resident in transferring to a facility that will arrange for 
the provision of hospice services when a resident requests a transfer.
    (2) If hospice care is furnished in an LTC facility through an 
agreement as specified in paragraph (o)(1)(i) of this section with a 
hospice, the LTC facility must meet the following requirements:
    (i) Ensure that the hospice services meet professional standards and 
principles that apply to individuals providing services in the facility, 
and to the timeliness of the services.
    (ii) Have a written agreement with the hospice that is signed by an 
authorized representative of the hospice and an authorized 
representative of the LTC facility before hospice care is furnished to 
any resident. The written agreement must set out at least the following:
    (A) The services the hospice will provide.
    (B) The hospice's responsibilities for determining the appropriate 
hospice plan of care as specified in Sec. 418.112 (d) of this chapter.
    (C) The services the LTC facility will continue to provide, based on 
each resident's plan of care.
    (D) A communication process, including how the communication will be 
documented between the LTC facility and the hospice provider, to ensure 
that the needs of the resident are addressed and met 24 hours per day.
    (E) A provision that the LTC facility immediately notifies the 
hospice about the following:
    (1) A significant change in the resident's physical, mental, social, 
or emotional status.
    (2) Clinical complications that suggest a need to alter the plan of 
care.
    (3) A need to transfer the resident from the facility for any 
condition.
    (4) The resident's death.
    (F) A provision stating that the hospice assumes responsibility for 
determining the appropriate course of hospice care, including the 
determination to change the level of services provided.
    (G) An agreement that it is the LTC facility's responsibility to 
furnish 24-hour room and board care, meet the resident's personal care 
and nursing needs in coordination with the hospice representative, and 
ensure that the level of care provided is appropriately based on the 
individual resident's needs.
    (H) A delineation of the hospice's responsibilities, including but 
not limited to, providing medical direction and management of the 
patient; nursing; counseling (including spiritual, dietary, and 
bereavement); social work; providing medical supplies, durable medical 
equipment, and drugs necessary for the palliation of pain and symptoms 
associated with the terminal illness and related conditions; and all 
other hospice services that are necessary for the care of the resident's 
terminal illness and related conditions.
    (I) A provision that when the LTC facility personnel are responsible 
for the administration of prescribed therapies, including those 
therapies determined appropriate by the hospice and delineated in the 
hospice plan of care, the LTC facility personnel may administer the 
therapies where permitted by State law and as specified by the LTC 
facility.
    (J) A provision stating that the LTC facility must report all 
alleged violations involving mistreatment, neglect, or verbal, mental, 
sexual, and physical abuse, including injuries of unknown source, and 
misappropriation of patient property by hospice personnel, to the 
hospice administrator immediately when the LTC facility becomes aware of 
the alleged violation.
    (K) A delineation of the responsibilities of the hospice and the LTC 
facility to provide bereavement services to LTC facility staff.
    (3) Each LTC facility arranging for the provision of hospice care 
under a written agreement must designate a

[[Page 95]]

member of the facility's interdisciplinary team who is responsible for 
working with hospice representatives to coordinate care to the resident 
provided by the LTC facility staff and hospice staff. The 
interdisciplinary team member must have a clinical background, function 
within their State scope of practice act, and have the ability to assess 
the resident or have access to someone that has the skills and 
capabilities to assess the resident. The designated interdisciplinary 
team member is responsible for the following:
    (i) Collaborating with hospice representatives and coordinating LTC 
facility staff participation in the hospice care planning process for 
those residents receiving these services.
    (ii) Communicating with hospice representatives and other healthcare 
providers participating in the provision of care for the terminal 
illness, related conditions, and other conditions, to ensure quality of 
care for the patient and family.
    (iii) Ensuring that the LTC facility communicates with the hospice 
medical director, the patient's attending physician, and other 
practitioners participating in the provision of care to the patient as 
needed to coordinate the hospice care with the medical care provided by 
other physicians.
    (iv) Obtaining the following information from the hospice:
    (A) The most recent hospice plan of care specific to each patient.
    (B) Hospice election form.
    (C) Physician certification and recertification of the terminal 
illness specific to each patient.
    (D) Names and contact information for hospice personnel involved in 
hospice care of each patient.
    (E) Instructions on how to access the hospice's 24-hour on-call 
system.
    (F) Hospice medication information specific to each patient.
    (G) Hospice physician and attending physician (if any) orders 
specific to each patient.
    (v) Ensuring that the LTC facility staff provides orientation in the 
policies and procedures of the facility, including patient rights, 
appropriate forms, and record keeping requirements, to hospice staff 
furnishing care to LTC residents.
    (4) Each LTC facility providing hospice care under a written 
agreement must ensure that each resident's written plan of care includes 
both the most recent hospice plan of care and a description of the 
services furnished by the LTC facility to attain or maintain the 
resident's highest practicable physical, mental, and psychosocial well-
being, as required at Sec. 483.25.
    (p) Social worker. Any facility with more than 120 beds must employ 
a qualified social worker on a full-time basis. A qualified social 
worker is:
    (1) An individual with a minimum of a bachelor's degree in social 
work or a bachelor's degree in a human services field including, but not 
limited to, sociology, gerontology, special education, rehabilitation 
counseling, and psychology; and
    (2) One year of supervised social work experience in a health care 
setting working directly with individuals.
    (q) Mandatory submission of staffing information based on payroll 
data in a uniform format. Long-term care facilities must electronically 
submit to CMS complete and accurate direct care staffing information, 
including information for agency and contract staff, based on payroll 
and other verifiable and auditable data in a uniform format according to 
specifications established by CMS.
    (1) Direct Care Staff. Direct Care Staff are those individuals who, 
through interpersonal contact with residents or resident care 
management, provide care and services to allow residents to attain or 
maintain the highest practicable physical, mental, and psychosocial 
well-being. Direct care staff does not include individuals whose primary 
duty is maintaining the physical environment of the long term care 
facility (for example, housekeeping).
    (2) Submission requirements. The facility must electronically submit 
to CMS complete and accurate direct care staffing information, including 
the following:
    (i) The category of work for each person on direct care staff 
(including, but not limited to, whether the individual is a registered 
nurse, licensed practical nurse, licensed vocational nurse, certified 
nursing assistant, therapist, or

[[Page 96]]

other type of medical personnel as specified by CMS);
    (ii) Resident census data; and
    (iii) Information on direct care staff turnover and tenure, and on 
the hours of care provided by each category of staff per resident per 
day (including, but not limited to, start date, end date (as 
applicable), and hours worked for each individual).
    (3) Distinguishing employee from agency and contract staff. When 
reporting information about direct care staff, the facility must specify 
whether the individual is an employee of the facility, or is engaged by 
the facility under contract or through an agency.
    (4) Data format. The facility must submit direct care staffing 
information in the uniform format specified by CMS.
    (5) Submission schedule. The facility must submit direct care 
staffing information on the schedule specified by CMS, but no less 
frequently than quarterly.

[56 FR 48877, Sept. 26, 1991, as amended at 56 FR 48918, Sept. 26, 1991; 
57 FR 7136, Feb. 28, 1992; 57 FR 43925, Sept. 23, 1992; 59 FR 56237, 
Nov. 10, 1994; 63 FR 26311, May 12, 1998; 68 FR 55539, Sept. 26, 2003; 
74 FR 40363, Aug. 11, 2009; 76 FR 9511, Feb. 18, 2011; 78 FR 16805, Mar. 
19, 2013; 78 FR 38605, June 27, 2013; 80 FR 46477, Aug. 4, 2015; 81 FR 
64032, Sept. 16, 2016. Redesignated and amended at 81 FR 68861, 68865, 
Oct. 4, 2016; 82 FR 32259, July 13, 2017; 84 FR 34735, July 18, 2019]



Sec. 483.73  Emergency preparedness.

    The LTC facility must comply with all applicable Federal, State and 
local emergency preparedness requirements. The LTC facility 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 LTC facility must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
annually. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach, 
including missing residents.
    (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 LTC facility 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, or Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The LTC facility 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 annually. 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--
    (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; and
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
residents in the LTC facility's care during and after an emergency. If 
on-duty staff and sheltered residents are relocated during the 
emergency, the LTC facility must document the specific name and location 
of the receiving facility or other location.
    (3) Safe evacuation from the LTC facility, which includes 
consideration of care and treatment needs of evacuees; staff 
responsibilities; transportation; identification of evacuation 
location(s); and primary and alternate

[[Page 97]]

means of communication with external sources of assistance.
    (4) A means to shelter in place for residents, staff, and volunteers 
who remain in the LTC 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 role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (7) The development of arrangements with other LTC facilities and 
other providers to receive residents in the event of limitations or 
cessation of operations to maintain the continuity of services to LTC 
residents.
    (8) The role of the LTC facility 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.
    (c) Communication plan. The LTC facility 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 
annually. 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 LTC facilities.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, or local emergency 
preparedness staff.
    (ii) The State Licensing and Certification Agency.
    (iii) The Office of the State Long-Term Care Ombudsman.
    (iv) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) LTC facility's staff.
    (ii) Federal, State, tribal, regional, or local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
residents under the LTC facility'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 LTC facility's 
occupancy, needs, and its ability to provide assistance, to the 
authority having jurisdiction or the Incident Command Center, or 
designee.
    (8) A method for sharing information from the emergency plan that 
the facility has determined is appropriate with residents and their 
families or representatives.
    (d) Training and testing. The LTC facility 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 annually.
    (1) Training program. The LTC facility must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.

[[Page 98]]

    (2) Testing. The LTC facility must conduct exercises to test the 
emergency plan at least twice per year, including unannounced staff 
drills using the emergency procedures. The LTC facility 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.
    (B) If the LTC facility experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the LTC 
facility is exempt from engaging its next required a 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 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 
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 LTC facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the LTC facility's emergency plan, as needed.
    (e) Emergency and standby power systems. The LTC facility must 
implement emergency and standby power systems based on the emergency 
plan set forth in paragraph (a) of this section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in 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), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The LTC facility 
must implement the emergency power system inspection, testing, and 
maintenance requirements found in the Health Care Facilities Code, NFPA 
110, and Life Safety Code.
    (3) Emergency generator fuel. LTC facilities that maintain an onsite 
fuel source to power emergency generators must have a plan for how it 
will keep emergency power systems operational during the emergency, 
unless it evacuates.
    (f) Integrated healthcare systems. If a LTC facility 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 LTC facility may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of 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--
    (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

[[Page 99]]

plan and training and testing programs that meet the requirements of 
paragraphs (c) and (d) of this section, respectively.
    (g) 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 obtain the material from the sources listed below. 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, Health Care Facilities Code 2012 edition, issued August 
11, 2011.
    (ii) Technical interim amendment (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.
    (xii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

[81 FR 64030, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016; 84 FR 51824, 
Sept. 30, 2019]



Sec. 483.75  Quality assurance and performance improvement.

    (a) Quality assurance and performance improvement (QAPI) program. 
Each LTC facility, including a facility that is part of a multiunit 
chain, must develop, implement, and maintain an effective, 
comprehensive, data-driven QAPI program that focuses on indicators of 
the outcomes of care and quality of life. The facility must--
    (1) Maintain documentation and demonstrate evidence of its ongoing 
QAPI program that meets the requirements of this section. This may 
include but is not limited to systems and reports demonstrating 
systematic identification, reporting, investigation, analysis, and 
prevention of adverse events; and documentation demonstrating the 
development, implementation, and evaluation of corrective actions or 
performance improvement activities;
    (2) Present its QAPI plan to the State Survey Agency no later than 1 
year after the promulgation of this regulation;
    (3) Present its QAPI plan to a State Survey Agency or Federal 
surveyor at each annual recertification survey and upon request during 
any other survey and to CMS upon request; and
    (4) Present documentation and evidence of its ongoing QAPI program's 
implementation and the facility's compliance with requirements to a 
State Survey Agency, Federal surveyor or CMS upon request.
    (b) Program design and scope. A facility must design its QAPI 
program to be ongoing, comprehensive, and to address the full range of 
care and services provided by the facility. It must:
    (1) Address all systems of care and management practices;
    (2) Include clinical care, quality of life, and resident choice;
    (3) Utilize the best available evidence to define and measure 
indicators of quality and facility goals that reflect processes of care 
and facility operations that have been shown to be predictive of desired 
outcomes for residents of a SNF or NF.

[[Page 100]]

    (4) Reflect the complexities, unique care, and services that the 
facility provides.
    (c) Program feedback, data systems and monitoring. A facility must 
establish and implement written policies and procedures for feedback, 
data collections systems, and monitoring, including adverse event 
monitoring. The policies and procedures must include, at a minimum, the 
following:
    (1) Facility maintenance of effective systems to obtain and use of 
feedback and input from direct care staff, other staff, residents, and 
resident representatives, including how such information will be used to 
identify problems that are high risk, high volume, or problem-prone, and 
opportunities for improvement.
    (2) Facility maintenance of effective systems to identify, collect, 
and use data and information from all departments, including but not 
limited to the facility assessment required at Sec. 483.70(e) and 
including how such information will be used to develop and monitor 
performance indicators.
    (3) Facility development, monitoring, and evaluation of performance 
indicators, including the methodology and frequency for such 
development, monitoring, and evaluation.
    (4) Facility adverse event monitoring, including the methods by 
which the facility will systematically identify, report, track, 
investigate, analyze and use data and information relating to adverse 
events in the facility, including how the facility will use the data to 
develop activities to prevent adverse events.
    (d) Program systematic analysis and systemic action. (1) The 
facility must take actions aimed at performance improvement and, after 
implementing those actions, measure its success, and track performance 
to ensure that improvements are realized and sustained.
    (2) The facility will develop and implement policies addressing:
    (i) How they will use a systematic approach to determine underlying 
causes of problems impacting larger systems;
    (ii) How they will develop corrective actions that will be designed 
to effect change at the systems level to prevent quality of care, 
quality of life, or safety problems ; and
    (iii) How the facility will monitor the effectiveness of its 
performance improvement activities to ensure that improvements are 
sustained.
    (e) Program activities. (1) The facility must set priorities for its 
performance improvement activities that focus on high-risk, high-volume, 
or problem-prone areas; consider the incidence, prevalence, and severity 
of problems in those areas; and affect health outcomes, resident safety, 
resident autonomy, resident choice, and quality of care.
    (2) Performance improvement activities must track medical errors and 
adverse resident events, analyze their causes, and implement preventive 
actions and mechanisms that include feedback and learning throughout the 
facility.
    (3) As a part of their performance improvement activities, the 
facility must conduct distinct performance improvement projects. The 
number and frequency of improvement projects conducted by the facility 
must reflect the scope and complexity of the facility's services and 
available resources, as reflected in the facility assessment required at 
Sec. 483.70(e). Improvement projects must include at least annually a 
project that focuses on high risk or problem-prone areas identified 
through the data collection and analysis described in paragraphs (c) and 
(d) of this section.
    (f) Governance and leadership. The governing body and/or executive 
leadership (or organized group or individual who assumes full legal 
authority and responsibility for operation of the facility) is 
responsible and accountable for ensuring that--
    (1) An ongoing QAPI program is defined, implemented, and maintained 
and addresses identified priorities.
    (2) The QAPI program is sustained during transitions in leadership 
and staffing;
    (3) The QAPI program is adequately resourced, including ensuring 
staff time, equipment, and technical training as needed;
    (4) The QAPI program identifies and prioritizes problems and 
opportunities that reflect organizational process, functions, and 
services provided to

[[Page 101]]

resident based on performance indicator data, and resident and staff 
input, and other information.
    (5) Corrective actions address gaps in systems, and are evaluated 
for effectiveness; and
    (6) Clear expectations are set around safety, quality, rights, 
choice, and respect.
    (g) Quality assessment and assurance. (1) A facility must maintain a 
quality assessment and assurance committee consisting at a minimum of:
    (i) The director of nursing services;
    (ii) The Medical Director or his or her designee;
    (iii) At least three other members of the facility's staff, at least 
one of who must be the administrator, owner, a board member or other 
individual in a leadership role; and
    (iv) The infection preventionist.
    (2) The quality assessment and assurance committee reports to the 
facility's governing body, or designated person(s) functioning as a 
governing body regarding its activities, including implementation of the 
QAPI program required under paragraphs (a) through (e) of this section. 
The committee must:
    (i) Meet at least quarterly and as needed to coordinate and evaluate 
activities under the QAPI program, such as identifying issues with 
respect to which quality assessment and assurance activities, including 
performance improvement projects required under the QAPI program, are 
necessary; and
    (ii) Develop and implement appropriate plans of action to correct 
identified quality deficiencies; and
    (iii) Regularly review and analyze data, including data collected 
under the QAPI program and data resulting from drug regimen reviews, and 
act on available data to make improvements.
    (h) Disclosure of information. A State or the Secretary may not 
require disclosure of the records of such committee except in so far as 
such disclosure is related to the compliance of such committee with the 
requirements of this section.
    (i) Sanctions. Good faith attempts by the committee to identify and 
correct quality deficiencies will not be used as a basis for sanctions.

[81 FR 68867, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.80  Infection control.

    The facility must establish and maintain an infection prevention and 
control program designed to provide a safe, sanitary, and comfortable 
environment and to help prevent the development and transmission of 
communicable diseases and infections.
    (a) Infection prevention and control program. The facility must 
establish an infection prevention and control program (IPCP) that must 
include, at a minimum, the following elements:
    (1) A system for preventing, identifying, reporting, investigating, 
and controlling infections and communicable diseases for all residents, 
staff, volunteers, visitors, and other individuals providing services 
under a contractual arrangement based upon the facility assessment 
conducted according to Sec. 483.70(e) and following accepted national 
standards;
    (2) Written standards, policies, and procedures for the program, 
which must include, but are not limited to:
    (i) A system of surveillance designed to identify possible 
communicable diseases or infections before they can spread to other 
persons in the facility;
    (ii) When and to whom possible incidents of communicable disease or 
infections should be reported;
    (iii) Standard and transmission-based precautions to be followed to 
prevent spread of infections;
    (iv) When and how isolation should be used for a resident; including 
but not limited to:
    (A) The type and duration of the isolation, depending upon the 
infectious agent or organism involved, and
    (B) A requirement that the isolation should be the least restrictive 
possible for the resident under the circumstances.
    (v) The circumstances under which the facility must prohibit 
employees with a communicable disease or infected skin lesions from 
direct contact with residents or their food, if direct contact will 
transmit the disease; and
    (vi) The hand hygiene procedures to be followed by staff involved in 
direct resident contact.
    (3) An antibiotic stewardship program that includes antibiotic use 
protocols and a system to monitor antibiotic use.

[[Page 102]]

    (4) A system for recording incidents identified under the facility's 
IPCP and the corrective actions taken by the facility.
    (b) Infection preventionist. The facility must designate one or more 
individual(s) as the infection preventionist(s) (IPs) who are 
responsible for the facility's IPCP. The IP must:
    (1) Have primary professional training in nursing, medical 
technology, microbiology, epidemiology, or other related field;
    (2) Be qualified by education, training, experience or 
certification;
    (3) Work at least part-time at the facility; and
    (4) Have completed specialized training in infection prevention and 
control.
    (c) IP participation on quality assessment and assurance committee. 
The individual designated as the IP, or at least one of the individuals 
if there is more than one IP, must be a member of the facility's quality 
assessment and assurance committee and report to the committee on the 
IPCP on a regular basis.
    (d) Influenza, pneumococcal, and COVID-19 immunizations--(1) 
Influenza. The facility must develop policies and procedures to ensure 
that--
    (i) Before offering the influenza immunization, each resident or the 
resident's representative receives education regarding the benefits and 
potential side effects of the immunization;
    (ii) Each resident is offered an influenza immunization October 1 
through March 31 annually, unless the immunization is medically 
contraindicated or the resident has already been immunized during this 
time period;
    (iii) The resident or the resident's representative has the 
opportunity to refuse immunization; and
    (iv) The resident's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the resident or resident's representative was provided 
education regarding the benefits and potential side effects of influenza 
immunization; and
    (B) That the resident either received the influenza immunization or 
did not receive the influenza immunization due to medical 
contraindications or refusal.
    (2) Pneumococcal disease. The facility must develop policies and 
procedures to ensure that--
    (i) Before offering the pneumococcal immunization, each resident or 
the resident's representative receives education regarding the benefits 
and potential side effects of the immunization;
    (ii) Each resident is offered a pneumococcal immunization, unless 
the immunization is medically contraindicated or the resident has 
already been immunized;
    (iii) The resident or the resident's representative has the 
opportunity to refuse immunization; and
    (iv) The resident's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the resident or resident's representative was provided 
education regarding the benefits and potential side effects of 
pneumococcal immunization; and
    (B) That the resident either received the pneumococcal immunization 
or did not receive the pneumococcal immunization due to medical 
contraindication or refusal.
    (3) COVID-19 immunizations. The LTC facility must develop and 
implement policies and procedures to ensure all the following:
    (i) When COVID-19 vaccine is available to the facility, each 
resident and staff member is offered the COVID-19 vaccine unless the 
immunization is medically contraindicated or the resident or staff 
member has already been immunized;
    (ii) Before offering COVID-19 vaccine, all staff members are 
provided with education regarding the benefits and risks and potential 
side effects associated with the vaccine;
    (iii) Before offering COVID-19 vaccine, each resident or the 
resident representative receives education regarding the benefits and 
risks and potential side effects associated with the COVID-19 vaccine;
    (iv) In situations where COVID-19 vaccination requires multiple 
doses, the resident, resident representative,

[[Page 103]]

or staff member is provided with current information regarding those 
additional doses, including any changes in the benefits or risks and 
potential side effects associated with the COVID-19 vaccine, before 
requesting consent for administration of any additional doses;
    (v) The resident, resident representative, or staff member has the 
opportunity to accept or refuse a COVID-19 vaccine, and change their 
decision;
    (vi) The resident's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the resident or resident representative was provided 
education regarding the benefits and potential risks associated with 
COVID-19 vaccine; and
    (B) Each dose of COVID-19 vaccine administered to the resident; or
    (C) If the resident did not receive the COVID-19 vaccine due to 
medical contraindications or refusal; and
    (vii) The facility maintains documentation related to staff COVID-19 
vaccination that includes at a minimum, the following:
    (A) That staff were provided education regarding the benefits and 
potential risks associated with COVID-19 vaccine;
    (B) Staff were offered the COVID-19 vaccine or information on 
obtaining COVID-19 vaccine; and
    (C) The COVID-19 vaccine status of staff and related information as 
indicated by the Centers for Disease Control and Prevention's National 
Healthcare Safety Network (NHSN).
    (e) Linens. Personnel must handle, store, process, and transport 
linens so as to prevent the spread of infection.
    (f) Annual review. The facility will conduct an annual review of its 
IPCP and update their program, as necessary.
    (g) COVID-19 reporting. The facility must--
    (1) Electronically report information about COVID-19 in a 
standardized format specified by the Secretary. This report must include 
but is not limited to--
    (i) Suspected and confirmed COVID-19 infections among residents and 
staff, including residents previously treated for COVID-19;
    (ii) Total deaths and COVID-19 deaths among residents and staff;
    (iii) Personal protective equipment and hand hygiene supplies in the 
facility;
    (iv) Ventilator capacity and supplies in the facility;
    (v) Resident beds and census;
    (vi) Access to COVID-19 testing while the resident is in the 
facility;
    (vii) Staffing shortages;
    (viii) The COVID-19 vaccine status of residents and staff, including 
total numbers of residents and staff, numbers of residents and staff 
vaccinated, numbers of each dose of COVID-19 vaccine received, and 
COVID-19 vaccination adverse events; and
    (ix) Therapeutics administered to residents for treatment of COVID-
19.
    (2) Provide the information specified in paragraph (g)(1) of this 
section at a frequency specified by the Secretary, but no less than 
weekly to the Centers for Disease Control and Prevention's National 
Healthcare Safety Network. This information will be posted publicly by 
CMS to support protecting the health and safety of residents, personnel, 
and the general public.
    (3) Inform residents, their representatives, and families of those 
residing in facilities by 5 p.m. the next calendar day following the 
occurrence of either a single confirmed infection of COVID-19, or three 
or more residents or staff with new-onset of respiratory symptoms 
occurring within 72 hours of each other. This information must--
    (i) Not include personally identifiable information;
    (ii) Include information on mitigating actions implemented to 
prevent or reduce the risk of transmission, including if normal 
operations of the facility will be altered; and
    (iii) Include any cumulative updates for residents, their 
representatives, and families at least weekly or by 5 p.m. the next 
calendar day following the subsequent occurrence of either: Each time a 
confirmed infection of COVID-19 is identified, or whenever three or more 
residents or staff with new onset of respiratory symptoms occur within 
72 hours of each other.
    (h) COVID-19 Testing. The LTC facility must test residents and 
facility staff, including individuals providing services under 
arrangement and volunteers, for COVID-19. At a minimum, for

[[Page 104]]

all residents and facility staff, including individuals providing 
services under arrangement and volunteers, the LTC facility must:
    (1) Conduct testing based on parameters set forth by the Secretary, 
including but not limited to:
    (i) Testing frequency;
    (ii) The identification of any individual specified in this 
paragraph diagnosed with COVID-19 in the facility;
    (iii) The identification of any individual specified in this 
paragraph with symptoms consistent with COVID-19 or with known or 
suspected exposure to COVID-19;
    (iv) The criteria for conducting testing of asymptomatic individuals 
specified in this paragraph, such as the positivity rate of COVID-19 in 
a county;
    (v) The response time for test results; and
    (vi) Other factors specified by the Secretary that help identify and 
prevent the transmission of COVID-19.
    (2) Conduct testing in a manner that is consistent with current 
standards of practice for conducting COVID-19 tests;
    (3) For each instance of testing:
    (i) Document that testing was completed and the results of each 
staff test; and
    (ii) Document in the resident records that testing was offered, 
completed (as appropriate to the resident's testing status), and the 
results of each test.
    (4) Upon the identification of an individual specified in this 
paragraph with symptoms consistent with COVID-19, or who tests positive 
for COVID-19, take actions to prevent the transmission of COVID-19.
    (5) Have procedures for addressing residents and staff, including 
individuals providing services under arrangement and volunteers, who 
refuse testing or are unable to be tested.
    (6) When necessary, such as in emergencies due to testing supply 
shortages, contact state and local health departments to assist in 
testing efforts, such as obtaining testing supplies or processing test 
results.

[81 FR 68868, Oct. 4, 2016, as amended at 85 FR 27627, May 8, 2020; 85 
FR 54873, Sept. 2, 2020; 86 FR 26335, May 13, 2021]



Sec. 483.85  Compliance and ethics program.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    Compliance and ethics program means, with respect to a facility, a 
program of the operating organization that--
    (1) Has been reasonably designed, implemented, and enforced so that 
it is likely to be effective in preventing and detecting criminal, 
civil, and administrative violations under the Act and in promoting 
quality of care; and
    (2) Includes, at a minimum, the required components specified in 
paragraph (c) of this section.
    High-level personnel means individual(s) who have substantial 
control over the operating organization or who have a substantial role 
in the making of policy within the operating organization.
    Operating organization means the individual(s) or entity that 
operates a facility.
    (b) General rule. Beginning November 28, 2019, the operating 
organization for each facility must have in operation a compliance and 
ethics program (as defined in paragraph (a) of this section) that meets 
the requirements of this section.
    (c) Required components for all facilities. The operating 
organization for each facility must develop, implement, and maintain an 
effective compliance and ethics program that contains, at a minimum, the 
following components:
    (1) Established written compliance and ethics standards, policies, 
and procedures to follow that are reasonably capable of reducing the 
prospect of criminal, civil, and administrative violations under the Act 
and promote quality of care, which include, but are not limited to, the 
designation of an appropriate compliance and ethics program contact to 
which individuals may report suspected violations, as well as an 
alternate method of reporting suspected violations anonymously without 
fear of retribution; and disciplinary standards that set out the 
consequences for committing violations for the operating organization's 
entire staff; individuals providing services under a contractual 
arrangement; and

[[Page 105]]

volunteers, consistent with the volunteers' expected roles.
    (2) Assignment of specific individuals within the high-level 
personnel of the operating organization with the overall responsibility 
to oversee compliance with the operating organization's compliance and 
ethics program's standards, policies, and procedures, such as, but not 
limited to, the chief executive officer (CEO), members of the board of 
directors, or directors of major divisions in the operating 
organization.
    (3) Sufficient resources and authority to the specific individuals 
designated in paragraph (c)(2) of this section to reasonably assure 
compliance with such standards, policies, and procedures.
    (4) Due care not to delegate substantial discretionary authority to 
individuals who the operating organization knew, or should have known 
through the exercise of due diligence, had a propensity to engage in 
criminal, civil, and administrative violations under the Social Security 
Act.
    (5) The facility takes steps to effectively communicate the 
standards, policies, and procedures in the operating organization's 
compliance and ethics program to the operating organization's entire 
staff; individuals providing services under a contractual arrangement; 
and volunteers, consistent with the volunteers' expected roles. 
Requirements include, but are not limited to, mandatory participation in 
training as set forth at Sec. 483.95(f) or orientation programs, or 
disseminating information that explains in a practical manner what is 
required under the program.
    (6) The facility takes reasonable steps to achieve compliance with 
the program's standards, policies, and procedures. Such steps include, 
but are not limited to, utilizing monitoring and auditing systems 
reasonably designed to detect criminal, civil, and administrative 
violations under the Act by any of the operating organization's staff, 
individuals providing services under a contractual arrangement, or 
volunteers, having in place and publicizing a reporting system whereby 
any of these individuals could report violations by others anonymously 
within the operating organization without fear of retribution, and 
having a process for ensuring the integrity of any reported data.
    (7) Consistent enforcement of the operating organization's 
standards, policies, and procedures through appropriate disciplinary 
mechanisms, including, as appropriate, discipline of individuals 
responsible for the failure to detect and report a violation to the 
compliance and ethics program contact identified in the operating 
organization's compliance and ethics program.
    (8) After a violation is detected, the operating organization must 
ensure that all reasonable steps identified in its program are taken to 
respond appropriately to the violation and to prevent further similar 
violations, including any necessary modification to the operating 
organization's program to prevent and detect criminal, civil, and 
administrative violations under the Act.
    (d) Additional required components for operating organizations with 
five or more facilities. In addition to all of the other requirements in 
paragraphs (a), (b), (c), and (e) of this section, operating 
organizations that operate five or more facilities must also include, at 
a minimum, the following components in their compliance and ethics 
program:
    (1) A mandatory annual training program on the operating 
organization's compliance and ethics program that meets the requirements 
set forth in Sec. 483.95(f).
    (2) A designated compliance officer for whom the operating 
organization's compliance and ethics program is a major responsibility. 
This individual must report directly to the operating organization's 
governing body and not be subordinate to the general counsel, chief 
financial officer or chief operating officer.
    (3) Designated compliance liaisons located at each of the operating 
organization's facilities.
    (e) Annual review. The operating organization for each facility must 
review its compliance and ethics program annually and revise its program 
as needed to reflect changes in all applicable laws or regulations and 
within the operating organization and its facilities to improve its 
performance in

[[Page 106]]

deterring, reducing, and detecting violations under the Act and in 
promoting quality of care.

[81 FR 68869, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.90  Physical environment.

    The facility must be designed, constructed, equipped, and maintained 
to protect the health and safety of residents, personnel and the public.
    (a) Life safety from fire. (1) Except as otherwise provided in this 
section--
    (i) The LTC facility must meet the applicable provisions and must 
proceed in accordance with the Life Safety Code (NFPA 101 and Tentative 
Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
    (ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor 
doors and doors to rooms containing flammable or combustible materials 
must be provided with positive latching hardware. Roller latches are 
prohibited on such doors.
    (2) 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 long-
term care facility, but only if the waiver will not adversely affect the 
health and safety of the patients.
    (3) The provisions of the Life safety Code do not apply in a State 
where CMS finds, in accordance with applicable provisions of sections 
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of the Act, that a fire and 
safety code imposed by State law adequately protects patients, residents 
and personnel in long term care facilities.
    (4) A long-term care facility may install alcohol-based hand rub 
dispensers in its facility if the dispensers are installed in a manner 
that adequately protects against inappropriate access.
    (5) A long term care facility must:
    (i) Install, at least, battery-operated single station smoke alarms 
in accordance with the manufacturer's recommendations in resident 
sleeping rooms and common areas.
    (ii) Have a program for inspection, testing, maintenance, and 
battery replacement that conforms to the manufacturer's recommendations 
and that verifies correct operation of the smoke alarms.
    (iii) Exception:
    (A) The facility has system-based smoke detectors in patient rooms 
and common areas that are installed, tested, and maintained in 
accordance with NFPA 72, National Fire Alarm Code, for system-based 
smoke detectors; or
    (B) The facility is fully sprinklered in accordance with NFPA 13, 
Standard for the Installation of Sprinkler Systems.
    (6) A long term care facility must:
    (i) Install an approved, supervised automatic sprinkler system in 
accordance with the 1999 edition of NFPA 13, Standard for the 
Installation of Sprinkler Systems, as incorporated by reference, 
throughout the building by August 13, 2013. The Director of the Office 
of the Federal Register has approved the NFPA 13 1999 edition of the 
Standard for the Installation of Sprinkler Systems, issued July 22, 1999 
for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. A copy of the Code is available for inspection 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. Copies may be obtained 
from the National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02269.
    (ii) Test, inspect, and maintain an approved, supervised automatic 
sprinkler system in accordance with the 1998 edition of NFPA 25, 
Standard for the Inspection, Testing, and Maintenance of Water-Based 
Fire Protection Systems, as incorporated by reference. The Director of 
the Office of the Federal Register has approved the NFPA 25, Standard 
for the Inspection, Testing, and Maintenance of Water-Based Fire 
Protection Systems, 1998 edition, issued January 16, 1998 for 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. A copy of the Code is available for inspection at the CMS 
Information

[[Page 107]]

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. Copies may be obtained from the National Fire 
Protection Association, 1 Batterymarch Park, Quincy, MA 02269.
    (iii) Subject to approval by CMS, a long term care facility may be 
granted an extension of the sprinkler installation deadline for a time 
period not to exceed 2 years from August 13, 2013, if the facility meets 
all of the following conditions:
    (A) It is in the process of replacing its current building, or 
undergoing major modifications to improve the living conditions for 
residents in all unsprinklered living areas that requires the movement 
of corridor, room, partition, or structural walls or supports, in 
addition to the installation of a sprinkler system; or, has had its 
planned sprinkler installation so impaired by a disaster or emergency, 
as indicated by a declaration under section 319 of the Public Health 
Service Act, that CMS finds it would be impractical to meet the 
sprinkler installation due date.
    (B) It demonstrates that it has made the necessary financial 
commitments to complete the building replacement or modification; or 
pursuant to a declared disaster or emergency, CMS finds it impractical 
to make reasonable and necessary financial commitments.
    (C) Before applying for the deadline extension, it has submitted 
plans to State and local authorities that are necessary for approval of 
the replacement building or major modification that includes the 
required sprinkler installation, and has received approval of the plans 
from State and local authorities.
    (D) It agrees to complete interim steps to improve fire safety, as 
determined by CMS.
    (iv) An extension granted under paragraph (a)(8)(iii) of this 
section may be renewed once, for an additional period not to exceed 1 
year, if the following conditions are met:
    (A) CMS finds that extenuating circumstances beyond the control of 
the facility will prevent full compliance with the provisions in 
paragraph (a)(8)(i) of this section by the end of the first waiver 
period.
    (B) All other conditions of paragraph (a)(8)(iii) of this section 
are met.
    (7) Buildings must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (8) When a sprinkler system is shut down for more than 10 hours, the 
LTC facility must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (b) Standard: Building safety. Except as otherwise provided in this 
section, the LTC facility 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 LTC facility.
    (2) If application of the Health Care Facilities Code required under 
paragraph (b) of this section would result in unreasonable hardship for 
the LTC facility, 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 residents.
    (c) Emergency power. (1) An emergency electrical power system must 
supply power adequate at least for lighting all entrances and exits; 
equipment to maintain the fire detection, alarm, and extinguishing 
systems; and life support systems in the event the normal electrical 
supply is interrupted.
    (2) When life support systems are used, the facility must provide 
emergency electrical power with an emergency generator (as defined in 
NFPA 99, Health Care Facilities) that is located on the premises.

[[Page 108]]

    (d) Space and equipment. The facility must--
    (1) Provide sufficient space and equipment in dining, health 
services, recreation, living, and program areas to enable staff to 
provide residents with needed services as required by these standards 
and as identified in each resident's assessment and plan of care;
    (2) Maintain all mechanical, electrical, and patient care equipment 
in safe operating condition; and
    (3) Conduct regular inspection of all bed frames, mattresses, and 
bed rails, if any, as part of a regular maintenance program to identify 
areas of possible entrapment. When bed rails and mattresses are used and 
purchased separately from the bed frame, the facility must ensure that 
the bed rails, mattress, and bed frame are compatible.
    (e) Resident rooms. Resident rooms must be designed and equipped for 
adequate nursing care, comfort, and privacy of residents.
    (1) Bedrooms must--
    (i) Accommodate no more than four residents. For facilities that 
receive approval of construction or reconstruction plans by State and 
local authorities or are newly certified after November 28, 2016, 
bedrooms must accommodate no more than two residents.
    (ii) Measure at least 80 square feet per resident in multiple 
resident bedrooms, and at least 100 square feet in single resident 
rooms;
    (iii) Have direct access to an exit corridor;
    (iv) Be designed or equipped to assure full visual privacy for each 
resident;
    (v) In facilities initially certified after March 31, 1992, except 
in private rooms, each bed must have ceiling suspended curtains, which 
extend around the bed to provide total visual privacy in combination 
with adjacent walls and curtains;
    (vi) Have at least one window to the outside; and
    (vii) Have a floor at or above grade level.
    (2) The facility must provide each resident with--
    (i) A separate bed of proper size and height for the safety and 
convenience of the resident;
    (ii) A clean, comfortable mattress;
    (iii) Bedding appropriate to the weather and climate; and
    (iv) Functional furniture appropriate to the resident's needs, and 
individual closet space in the resident's bedroom with clothes racks and 
shelves accessible to the resident.
    (3) CMS, or in the case of a nursing facility the survey agency, may 
permit variations in requirements specified in paragraphs (d)(1) (i) and 
(ii) of this section relating to rooms in individual cases when the 
facility demonstrates in writing that the variations--
    (i) Are in accordance with the special needs of the residents; and
    (ii) Will not adversely affect residents' health and safety.
    (f) Bathroom facilities. Each resident room must be equipped with or 
located near toilet and bathing facilities. For facilities that receive 
approval of construction from State and local authorities or are newly 
certified after November 28, 2016, each resident room must have its own 
bathroom equipped with at least a commode and sink.
    (g) Resident call system. The facility must be adequately equipped 
to allow residents to call for staff assistance through a communication 
system which relays the call directly to a staff member or to a 
centralized staff work area from--
    (1) Each resident's bedside; and
    (2) Toilet and bathing facilities.
    (h) Dining and resident activities. The facility must provide one or 
more rooms designated for resident dining and activities. These rooms 
must--
    (1) Be well lighted;
    (2) Be well ventilated;
    (3) Be adequately furnished; and
    (4) Have sufficient space to accommodate all activities.
    (i) Other environmental conditions. The facility must provide a 
safe, functional, sanitary, and comfortable environment for the 
residents, staff and the public. The facility must--
    (1) Establish procedures to ensure that water is available to 
essential areas when there is a loss of normal water supply;
    (2) Have adequate outside ventilation by means of windows, or 
mechanical ventilation, or a combination of the two;

[[Page 109]]

    (3) Equip corridors with firmly secured handrails on each side; and
    (4) Maintain an effective pest control program so that the facility 
is free of pests and rodents.
    (5) Establish policies, in accordance with applicable Federal, 
State, and local laws and regulations, regarding smoking, smoking areas, 
and smoking safety that also take into account non-smoking residents.
    (j) 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]

[56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992; 
68 FR 1386, Jan. 10, 2003; 69 FR 49268, Aug. 11, 2004; 70 FR 15238, Mar. 
25, 2005; 71 FR 55340, Sept. 22, 2006; 73 FR 47091, Aug. 13, 2008; 79 FR 
27155, May 12, 2014; 81 FR 26899, May 4, 2016; 81 FR 42548, June 30, 
2016. Redesignated and amended at 81 FR 68861, 68870, Oct. 4, 2016; 82 
FR 32259, July 13, 2017; 86 FR 42524, Aug. 4, 2021]



Sec. 483.95  Training requirements.

    A facility must develop, implement, and maintain an effective 
training program for all new and existing staff; individuals providing 
services under a contractual arrangement; and volunteers, consistent 
with their expected roles. A facility must determine the amount and 
types of training necessary based on a facility assessment as specified 
at Sec. 483.70(e). Training topics must include but are not limited 
to--
    (a) Communication. A facility must include effective communications 
as mandatory training for direct care staff.
    (b) Resident's rights and facility responsibilities. A facility must 
ensure that staff members are educated on the rights of the resident and 
the responsibilities of a facility to properly care for its residents as 
set forth at Sec. 483.10, respectively.
    (c) Abuse, neglect, and exploitation. In addition to the freedom 
from abuse, neglect, and exploitation requirements in Sec. 483.12, 
facilities must also provide training to their staff that at a minimum 
educates staff on--
    (1) Activities that constitute abuse, neglect, exploitation, and 
misappropriation of resident property as set forth at Sec. 483.12.
    (2) Procedures for reporting incidents of abuse, neglect, 
exploitation, or the misappropriation of resident property.
    (3) Dementia management and resident abuse prevention.
    (d) Quality assurance and performance improvement. A facility must 
include as part of its QAPI program mandatory training that outlines and 
informs staff of the elements and goals of the facility's QAPI program 
as set forth at Sec. 483.75.
    (e) Infection control. A facility must include as part of its 
infection prevention and control program mandatory training that 
includes the written

[[Page 110]]

standards, policies, and procedures for the program as described at 
Sec. 483.80(a)(2).
    (f) Compliance and ethics. The operating organization for each 
facility must include as part of its compliance and ethics program, as 
set forth at Sec. 483.85--
    (1) An effective way to communicate that program's standards, 
policies, and procedures through a training program or in another 
practical manner which explains the requirements under the program.
    (2) Annual training if the operating organization operates five or 
more facilities.
    (g) Required in-service training for nurse aides. In-service 
training must--
    (1) Be sufficient to ensure the continuing competence of nurse 
aides, but must be no less than 12 hours per year.
    (2) Include dementia management training and resident abuse 
prevention training.
    (3) Address areas of weakness as determined in nurse aides' 
performance reviews and facility assessment at Sec. 483.70(e) and may 
address the special needs of residents as determined by the facility 
staff.
    (4) For nurse aides providing services to individuals with cognitive 
impairments, also address the care of the cognitively impaired.
    (h) Required training of feeding assistants. A facility must not use 
any individual working in the facility as a paid feeding assistant 
unless that individual has successfully completed a State-approved 
training program for feeding assistants, as specified in Sec. 483.160.
    (i) Behavioral health. A facility must provide behavioral health 
training consistent with the requirements at Sec. 483.40 and as 
determined by the facility assessment at Sec. 483.70(e).

[81 FR 68870, Oct. 4, 2016]



 Subpart C_Preadmission Screening and Annual Review of Mentally Ill and 
                      Mentally Retarded Individuals

    Source: 57 FR 56506, Nov. 30, 1992, unless otherwise noted.



Sec. 483.100  Basis.

    The requirements of Sec. Sec. 483.100 through 483.138 governing the 
State's responsibility for preadmission screening and annual resident 
review (PASARR) of individuals with mental illness and intellectual 
disability are based on section 1919(e)(7) of the Act.



Sec. 483.102  Applicability and definitions.

    (a) This subpart applies to the screening or reviewing of all 
individuals with mental illness or intellectual disability who apply to 
or reside in Medicaid certified NFs regardless of the source of payment 
for the NF services, and regardless of the individual's or resident's 
known diagnoses.
    (b) Definitions. As used in this subpart--
    (1) An individual is considered to have a serious mental illness 
(MI) if the individual meets the following requirements on diagnosis, 
level of impairment and duration of illness:
    (i) Diagnosis. The individual has a major mental disorder 
diagnosable under the Diagnostic and Statistical Manual of Mental 
Disorders, 3rd edition, revised in 1987.
    Incorporation of the 1987 edition of the Diagnostic and Statistical 
Manual of Mental Disorders, 3rd edition, was approved by the Director of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51 that govern the use of incorporation by reference. \1\
---------------------------------------------------------------------------

    \1\ The Diagnostic and Statistical Manual of Mental Disorders is 
available for inspection at the Centers for Medicare & Medicaid 
Services, room 132, East High Rise Building, 6325 Security Boulevard, 
Baltimore, Maryland, 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. Copies 
may be obtained from the American Psychiatric Association, Division of 
Publications and Marketing, 1400 K Street, NW., Washington, DC 20005.
---------------------------------------------------------------------------

    This mental disorder is--
    (A) A schizophrenic, mood, paranoid, panic or other severe anxiety 
disorder; somatoform disorder; personality disorder; other psychotic 
disorder; or another mental disorder that may lead to a chronic 
disability; but

[[Page 111]]

    (B) Not a primary diagnosis of dementia, including Alzheimer's 
disease or a related disorder, or a non-primary diagnosis of dementia 
unless the primary diagnosis is a major mental disorder as defined in 
paragraph (b)(1)(i)(A) of this section.
    (ii) Level of impairment. The disorder results in functional 
limitations in major life activities within the past 3 to 6 months that 
would be appropriate for the individual's developmental stage. An 
individual typically has at least one of the following characteristics 
on a continuing or intermittent basis:
    (A) Interpersonal functioning. The individual has serious difficulty 
interacting appropriately and communicating effectively with other 
persons, has a possible history of altercations, evictions, firing, fear 
of strangers, avoidance of interpersonal relationships and social 
isolation;
    (B) Concentration, persistence, and pace. The individual has serious 
difficulty in sustaining focused attention for a long enough period to 
permit the completion of tasks commonly found in work settings or in 
work-like structured activities occurring in school or home settings, 
manifests difficulties in concentration, inability to complete simple 
tasks within an established time period, makes frequent errors, or 
requires assistance in the completion of these tasks; and
    (C) Adaptation to change. The individual has serious difficulty in 
adapting to typical changes in circumstances associated with work, 
school, family, or social interaction, manifests agitation, exacerbated 
signs and symptoms associated with the illness, or withdrawal from the 
situation, or requires intervention by the mental health or judicial 
system.
    (iii) Recent treatment. The treatment history indicates that the 
individual has experienced at least one of the following:
    (A) Psychiatric treatment more intensive than outpatient care more 
than once in the past 2 years (e.g., partial hospitalization or 
inpatient hospitalization); or
    (B) Within the last 2 years, due to the mental disorder, experienced 
an episode of significant disruption to the normal living situation, for 
which supportive services were required to maintain functioning at home, 
or in a residential treatment environment, or which resulted in 
intervention by housing or law enforcement officials.
    (2) An individual is considered to have dementia if he or she has a 
primary diagnosis of dementia, as described in the Diagnostic and 
Statistical Manual of Mental Disorders, 3rd edition, revised in 1987, or 
a non-primary diagnosis of dementia unless the primary diagnosis is a 
major mental disorder as defined in paragraph (b)(1)(i)(A) of this 
section.
    (3) An individual is considered to have intellectual disability 
(IID) if he or she has--
    (i) A level of retardation (mild, moderate, severe or profound) 
described in the American Association on Intellectual Disability's 
Manual on Classification in Intellectual Disability (1983). 
Incorporation by reference of the 1983 edition of the American 
Association on Intellectual Disability's Manual on Classification in 
Intellectual Disability was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 that 
govern the use of incorporations by reference;\2\ or
---------------------------------------------------------------------------

    \2\ The American Association on Intellectual Disability's Manual on 
Classification in Intellectual Disability is available for inspection at 
the Centers for Medicare & Medicaid Services, Room 132, East High Rise 
Building, 6325 Security Boulevard, Baltimore, Maryland, 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. Copies may be obtained from the American Association 
on Intellectual Disability, 1719 Kalorama Rd., NW., Washington, DC 
20009.
---------------------------------------------------------------------------

    (ii) A related condition as defined by Sec. 435.1010 of this 
chapter.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993; 71 FR 39229, 
July 12, 2006]



Sec. 483.104  State plan requirement.

    As a condition of approval of the State plan, the State must operate 
a preadmission screening and annual resident review program that meets

[[Page 112]]

the requirements of Sec. Sec. 483.100 through 438.138.



Sec. 483.106  Basic rule.

    (a) Requirement. The State PASARR program must require--(1) 
Preadmission screening of all individuals with mental illness or 
intellectual disability who apply as new admissions to Medicaid NFs on 
or after January 1, 1989;
    (2) Initial review, by April 1, 1990, of all current residents with 
intellectual disability or mental illness who entered Medicaid NFs prior 
to January 1, 1989; and
    (3) At least annual review, as of April 1, 1990, of all residents 
with mental illness or intellectual disability, regardless of whether 
they were first screened under the preadmission screening or annual 
resident review requirements.
    (b) Admissions, readmissions and interfacility transfers--(1) New 
admission. An individual is a new admission if he or she is admitted to 
any NF for the first time or does not qualify as a readmission. With the 
exception of certain hospital discharges described in paragraph (b)(2) 
of this section, new admissions are subject to preadmission screening.
    (2) Exempted hospital discharge. (i) An exempted hospital discharge 
means an individual--
    (A) Who is admitted to any NF directly from a hospital after 
receiving acute inpatient care at the hospital;
    (B) Who requires NF services for the condition for which he or she 
received care in the hospital; and
    (C) Whose attending physician has certified before admission to the 
facility that the individual is likely to require less than 30 days 
nursing facility services.
    (ii) If an individual who enters a NF as an exempted hospital 
discharge is later found to require more than 30 days of NF care, the 
State mental health or intellectual disability authority must conduct an 
annual resident review within 40 calendar days of admission.
    (3) Readmissions. An individual is a readmission if he or she was 
readmitted to a facility from a hospital to which he or she was 
transferred for the purpose of receiving care. Readmissions are subject 
to annual resident review rather than preadmission screening.
    (4) Interfacility transfers--(i) An interfacility transfer occurs 
when an individual is transferred from one NF to another NF, with or 
without an intervening hospital stay. Interfacility transfers are 
subject to annual resident review rather than preadmission screening.
    (ii) In cases of transfer of a resident with MI or IID from a NF to 
a hospital or to another NF, the transferring NF is responsible for 
ensuring that copies of the resident's most recent PASARR and resident 
assessment reports accompany the transferring resident.
    (c) Purpose. The preadmission screening and annual resident review 
process must result in determinations based on a physical and mental 
evaluation of each individual with mental illness or intellectual 
disability, that are described in Sec. Sec. 483.112 and 483.114.
    (d) Responsibility for evaluations and determinations. The PASARR 
determinations of whether an individual requires the level of services 
provided by a NF and whether specialized services are needed--
    (1) For individuals with mental illness, must be made by the State 
mental health authority and be based on an independent physical and 
mental evaluation performed by a person or entity other than the State 
mental health authority; and
    (2) For individuals with intellectual disability, must be made by 
the State intellectual disability or developmental disabilities 
authority.
    (e) Delegation of responsibility--(1) The State mental health and 
intellectual disability authorities may delegate by subcontract or 
otherwise the evaluation and determination functions for which they are 
responsible to another entity only if--
    (i) The State mental health and intellectual disability authorities 
retain ultimate control and responsibility for the performance of their 
statutory obligations;
    (ii) The two determinations as to the need for NF services and for 
specialized services are made, based on a consistent analysis of the 
data; and
    (iii) The entity to which the delegation is made is not a NF or an 
entity

[[Page 113]]

that has a direct or indirect affiliation or relationship with a NF.
    (2) The State intellectual disability authority has responsibility 
for both the evaluation and determination functions for individuals with 
IID whereas the State mental health authority has responsibility only 
for the determination function.
    (3) The evaluation of individuals with MI cannot be delegated by the 
State mental health authority because it does not have responsibility 
for this function. The evaluation function must be performed by a person 
or entity other than the State mental health authority. In designating 
an independent person or entity to perform MI evaluations, the State 
must not use a NF or an entity that has a direct or indirect affiliation 
or relationship with a NF.

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



Sec. 483.108  Relationship of PASARR to other Medicaid processes.

    (a) PASARR determinations made by the State mental health or 
intellectual disability authorities cannot be countermanded by the State 
Medicaid agency, either in the claims process or through other 
utilization control/review processes or by the State survey and 
certification agency. Only appeals determinations made through the 
system specified in subpart E of this part may overturn a PASARR 
determination made by the State mental health or intellectual disability 
authorities.
    (b) In making their determinations, however, the State mental health 
and intellectual disability authorities must not use criteria relating 
to the need for NF care or specialized services that are inconsistent 
with this regulation and any supplementary criteria adopted by the State 
Medicaid agency under its approved State plan.
    (c) To the maximum extent practicable, in order to avoid duplicative 
testing and effort, the PASARR must be coordinated with the routine 
resident assessments required by Sec. 483.20(b).



Sec. 483.110  Out-of-State arrangements.

    (a) Basic rule. The State in which the individual is a State 
resident (or would be a State resident at the time he or she becomes 
eligible for Medicaid), as defined in Sec. 435.403 of this chapter, 
must pay for the PASARR and make the required determinations, in 
accordance with Sec. 431.52(b).
    (b) Agreements. A State may include arrangements for PASARR in its 
provider agreements with out-of-State facilities or reciprocal 
interstate agreements.

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



Sec. 483.112  Preadmission screening of applicants for admission
to NFs.

    (a) Determination of need for NF services. For each NF applicant 
with MI or IID, the State mental health or intellectual disability 
authority (as appropriate) must determine, in accordance with Sec. 
483.130, whether, because of the resident's physical and mental 
condition, the individual requires the level of services provided by a 
NF.
    (b) Determination of need for specialized services. If the 
individual with mental illness or intellectual disability is determined 
to require a NF level of care, the State mental health or intellectual 
disability authority (as appropriate) must also determine, in accordance 
with Sec. 483.130, whether the individual requires specialized services 
for the mental illness or intellectual disability, as defined in Sec. 
483.120.
    (c) Timeliness--(1) Except as specified in paragraph (c)(4) of this 
section, a preadmission screening determination must be made in writing 
within an annual average of 7 to 9 working days of referral of the 
individual with MI or IID by whatever agent performs the Level I 
identification, under Sec. 483.128(a) of this part, to the State mental 
health or intellectual disability authority for screening. (See Sec. 
483.128(a) for discussion of Level I evaluation.)
    (2) The State may convey determinations verbally to nursing 
facilities and the individual and confirm them in writing.
    (3) The State may compute separate annual averages for the mentally 
ill and individuals with intellectual disabilities/developmentally 
disabled populations.
    (4) The Secretary may grant an exception to the timeliness standard 
in paragraph (c)(1) of this section when the State--

[[Page 114]]

    (i) Exceeds the annual average; and
    (ii) Provides justification satisfactory to the Secretary that a 
longer time period was necessary.



Sec. 483.114  Annual review of NF residents.

    (a) Individuals with mental illness. For each resident of a NF who 
has mental illness, the State mental health authority must determine in 
accordance with Sec. 483.130 whether, because of the resident's 
physical and mental condition, the resident requires--
    (1) The level of services provided by--
    (i) A NF;
    (ii) An inpatient psychiatric hospital for individuals under age 21, 
as described in section 1905(h) of the Act; or
    (iii) An institution for mental diseases providing medical 
assistance to individuals age 65 or older; and
    (2) Specialized services for mental illness, as defined in Sec. 
483.120.
    (b) Individuals with intellectual disability. For each resident of a 
NF who has intellectual disability, the State intellectual disability or 
developmental disability authority must determine in accordance with 
Sec. 483.130 whether, because of his or her physical or mental 
condition, the resident requires--
    (1) The level of services provided by a NF or an intermediate care 
facility for individuals with intellectual disabilities; and
    (2) Specialized services for intellectual disability as defined in 
Sec. 483.120.
    (c) Frequency of review--(1) A review and determination must be 
conducted for each resident of a Medicaid NF who has mental illness or 
intellectual disability not less often than annually.
    (2) ``Annually'' is defined as occurring within every fourth quarter 
after the previous preadmission screen or annual resident review.
    (d) April 1, 1990 deadline for initial reviews. The first set of 
annual reviews on residents who entered the NF prior to January 1, 1989, 
must be completed by April 1, 1990.



Sec. 483.116  Residents and applicants determined to require NF level 
of services.

    (a) Individuals needing NF services. If the State mental health or 
intellectual disability authority determines that a resident or 
applicant for admission to a NF requires a NF level of services, the NF 
may admit or retain the individual.
    (b) Individuals needing NF services and specialized services. If the 
State mental health or intellectual disability authority determines that 
a resident or applicant for admission requires both a NF level of 
services and specialized services for the mental illness or intellectual 
disability--
    (1) The NF may admit or retain the individual; and
    (2) The State must provide or arrange for the provision of the 
specialized services needed by the individual while he or she resides in 
the NF.



Sec. 483.118  Residents and applicants determined not to require NF
level of services.

    (a) Applicants who do not require NF services. If the State mental 
health or intellectual disability authority determines that an applicant 
for admission to a NF does not require NF services, the applicant cannot 
be admitted. NF services are not a covered Medicaid service for that 
individual, and further screening is not required.
    (b) Residents who require neither NF services nor specialized 
services for MI or IID. If the State mental health or intellectual 
disability authority determines that a resident requires neither the 
level of services provided by a NF nor specialized services for MI or 
IID, regardless of the length of stay in the facility, the State must--
    (1) Arrange for the safe and orderly discharge of the resident from 
the facility in accordance with Sec. 483.15(b); and
    (2) Prepare and orient the resident for discharge.
    (c) Residents who do not require NF services but require specialized 
services for MI or IID--(1) Long term residents. Except as otherwise may 
be provided in an alternative disposition plan adopted under section 
1919(e)(7)(E) of the Act, for any resident who has continuously resided 
in a NF for at least 30 months before the date of the determination, and 
who requires only specialized services as defined in Sec. 483.120, the 
State must, in consultation with the resident's family or legal 
representative and caregivers--

[[Page 115]]

    (i) Offer the resident the choice of remaining in the facility or of 
receiving services in an alternative appropriate setting;
    (ii) Inform the resident of the institutional and noninstitutional 
alternatives covered under the State Medicaid plan for the resident;
    (iii) Clarify the effect on eligibility for Medicaid services under 
the State plan if the resident chooses to leave the facility, including 
its effect on readmission to the facility; and
    (iv) Regardless of the resident's choice, provide for, or arrange 
for the provision of specialized services for the mental illness or 
intellectual disability.
    (2) Short term residents. Except as otherwise may be provided in an 
alternative disposition plan adopted under section 1919(e)(7)(E) of the 
Act, for any resident who requires only specialized services, as defined 
in Sec. 483.120, and who has not continuously resided in a NF for at 
least 30 months before the date of the determination, the State must, in 
consultation with the resident's family or legal representative and 
caregivers--
    (i) Arrange for the safe and orderly discharge of the resident from 
the facility in accordance with Sec. 483.15(b);
    (ii) Prepare and orient the resident for discharge; and
    (iii) Provide for, or arrange for the provision of, specialized 
services for the mental illness or intellectual disability.
    (3) For the purpose of establishing length of stay in a NF, the 30 
months of continuous residence in a NF or longer--
    (i) Is calculated back from the date of the first annual resident 
review determination which finds that the individual is not in need of 
NF level of services;
    (ii) May include temporary absences for hospitalization or 
therapeutic leave; and
    (iii) May consist of consecutive residences in more than one NF.

[57 FR 56506, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]



Sec. 483.120  Specialized services.

    (a) Definition--(1) For mental illness, specialized services means 
the services specified by the State which, combined with services 
provided by the NF, results in the continuous and aggressive 
implementation of an individualized plan of care that--
    (i) Is developed and supervised by an interdisciplinary team, which 
includes a physician, qualified mental health professionals and, as 
appropriate, other professionals.
    (ii) Prescribes specific therapies and activities for the treatment 
of persons experiencing an acute episode of serious mental illness, 
which necessitates supervision by trained mental health personnel; and
    (iii) Is directed toward diagnosing and reducing the resident's 
behavioral symptoms that necessitated institutionalization, improving 
his or her level of independent functioning, and achieving a functioning 
level that permits reduction in the intensity of mental health services 
to below the level of specialized services at the earliest possible 
time.
    (2) For intellectual disability, specialized services means the 
services specified by the State which, combined with services provided 
by the NF or other service providers, results in treatment which meets 
the requirements of Sec. 483.440(a)(1).
    (b) Who must receive specialized services. The State must provide or 
arrange for the provision of specialized services, in accordance with 
this subpart, to all NF residents with MI or IID whose needs are such 
that continuous supervision, treatment and training by qualified mental 
health or intellectual disability personnel is necessary, as identified 
by the screening provided in Sec. 483.130 or Sec. Sec. 483.134 and 
483.136.
    (c) Services of lesser intensity than specialized services. The NF 
must provide mental health or intellectual disability services which are 
of a lesser intensity than specialized services to all residents who 
need such services.



Sec. 483.122  FFP for NF services.

    (a) Basic rule. Except as otherwise may be provided in an 
alternative disposition plan adopted under section 1919(e)(7)(E) of the 
Act, FFP is available in State expenditures for NF services provided to 
a Medicaid eligible individual subject to the requirements of

[[Page 116]]

this part only if the individual has been determined--
    (1) To need NF care under Sec. 483.116(a) or
    (2) Not to need NF services but to need specialized services, meets 
the requirements of Sec. 483.118(c)(1), and elects to stay in the NF.
    (b) FFP for late reviews. When a preadmission screening has not been 
performed prior to admission or an annual review is not performed 
timely, in accordance with Sec. 483.114(c), but either is performed at 
a later date, FFP is available only for services furnished after the 
screening or review has been performed, subject to the provisions of 
paragraph (a) of this section.



Sec. 483.124  FFP for specialized services.

    FFP is not available for specialized services furnished to NF 
residents as NF services.



Sec. 483.126  Appropriate placement.

    Placement of an individual with MI or IID in a NF may be considered 
appropriate only when the individual's needs are such that he or she 
meets the minimum standards for admission and the individual's needs for 
treatment do not exceed the level of services which can be delivered in 
the NF to which the individual is admitted either through NF services 
alone or, where necessary, through NF services supplemented by 
specialized services provided by or arranged for by the State.



Sec. 483.128  PASARR evaluation criteria.

    (a) Level I: Identification of individuals with MI or IID. The 
State's PASARR program must identify all individuals who are suspected 
of having MI or IID as defined in Sec. 483.102. This identification 
function is termed Level I. Level II is the function of evaluating and 
determining whether NF services and specialized services are needed. The 
State's performance of the Level I identification function must provide 
at least, in the case of first time identifications, for the issuance of 
written notice to the individual or resident and his or her legal 
representative that the individual or resident is suspected of having MI 
or IID and is being referred to the State mental health or intellectual 
disability authority for Level II screening.
    (b) Adaptation to culture, language, ethnic origin. Evaluations 
performed under PASARR and PASARR notices must be adapted to the 
cultural background, language, ethnic origin and means of communication 
used by the individual being evaluated.
    (c) Participation by individual and family. PASARR evaluations must 
involve--
    (1) The individual being evaluated;
    (2) The individual's legal representative, if one has been 
designated under State law; and
    (3) The individual's family if--
    (i) Available; and
    (ii) The individual or the legal representative agrees to family 
participation.
    (d) Interdisciplinary coordination. When parts of a PASARR 
evaluation are performed by more than one evaluator, the State must 
ensure that there is interdisciplinary coordination among the 
evaluators.
    (e) The State's PASARR program must use at least the evaluative 
criteria of Sec. 483.130 (if one or both determinations can easily be 
made categorically as described in Sec. 483.130) or of Sec. Sec. 
483.132 and 483.134 or Sec. 483.136 (or, in the case of individuals 
with both MI and IID, Sec. Sec. 483.132, 483.134 and 483.136 if a more 
extensive individualized evaluation is required).
    (f) Data. In the case of individualized evaluations, information 
that is necessary for determining whether it is appropriate for the 
individual with MI or IID to be placed in an NF or in another 
appropriate setting should be gathered throughout all applicable 
portions of the PASARR evaluation (Sec. Sec. 483.132 and 483.134 and/or 
Sec. 483.136). The two determinations relating to the need for NF level 
of care and specialized services are interrelated and must be based upon 
a comprehensive analysis of all data concerning the individual.
    (g) Preexisting data. Evaluators may use relevant evaluative data, 
obtained prior to initiation of preadmission screening or annual 
resident review, if the data are considered valid and accurate and 
reflect the current functional status of the individual. However, in

[[Page 117]]

the case of individualized evaluations, to supplement and verify the 
currency and accuracy of existing data, the State's PASARR program may 
need to gather additional information necessary to assess proper 
placement and treatment.
    (h) Findings. For both categorical and individualized 
determinations, findings of the evaluation must correspond to the 
person's current functional status as documented in medical and social 
history records.
    (i) Evaluation report: Individualized determinations. For 
individualized PASARR determinations, findings must be issued in the 
form of a written evaluative report which--
    (1) Identifies the name and professional title of person(s) who 
performed the evaluation(s) and the date on which each portion of the 
evaluation was administered;
    (2) Provides a summary of the medical and social history, including 
the positive traits or developmental strengths and weaknesses or 
developmental needs of the evaluated individual;
    (3) If NF services are recommended, identifies the specific services 
which are required to meet the evaluated individual's needs, including 
services required in paragraph (i)(5) of this section;
    (4) If specialized services are not recommended, identifies any 
specific intellectual disability or mental health services which are of 
a lesser intensity than specialized services that are required to meet 
the evaluated individual's needs;
    (5) If specialized services are recommended, identifies the specific 
intellectual disability or mental health services required to meet the 
evaluated individual's needs; and
    (6) Includes the bases for the report's conclusions.
    (j) Evaluation report: Categorical determinations. For categorical 
PASARR determinations, findings must be issued in the form of an 
abbreviated written evaluative report which--
    (1) Identifies the name and professional title of the person 
applying the categorical determination and the data on which the 
application was made;
    (2) Explains the categorical determination(s) that has (have) been 
made and, if only one of the two required determinations can be made 
categorically, describes the nature of any further screening which is 
required;
    (3) Identifies, to the extent possible, based on the available data, 
NF services, including any mental health or specialized psychiatric 
rehabilitative services, that may be needed; and
    (4) Includes the bases for the report's conclusions.
    (k) Interpretation of findings to individual. For both categorical 
and individualized determinations, findings of the evaluation must be 
interpreted and explained to the individual and, where applicable, to a 
legal representative designated under State law.
    (l) Evaluation report. The evaluator must send a copy of the 
evaluation report to the--
    (1) Individual or resident and his or her legal representative;
    (2) Appropriate State authority in sufficient time for the State 
authorities to meet the times identified in Sec. 483.112(c) for PASs 
and Sec. 483.114(c) for ARRs;
    (3) Admitting or retaining NF;
    (4) Individual's attending physician; and
    (5) The discharging hospital if the individual is seeking NF 
admission from a hospital.
    (m) The evaluation may be terminated if the evaluator finds at any 
time during the evaluation that the individual being evaluated--
    (1) Does not have MI or IID; or
    (2) Has--
    (i) A primary diagnosis of dementia (including Alzheimer's Disease 
or a related disorder); or
    (ii) A non-primary diagnosis of dementia without a primary diagnosis 
that is a serious mental illness, and does not have a diagnosis of IID 
or a related condition.

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



Sec. 483.130  PASARR determination criteria.

    (a) Basis for determinations. Determinations made by the State 
mental

[[Page 118]]

health or intellectual disability authority as to whether NF level of 
services and specialized services are needed must be based on an 
evaluation of data concerning the individual, as specified in paragraph 
(b) of this section.
    (b) Types of determinations. Determinations may be--
    (1) Advance group determinations, in accordance with this section, 
by category that take into account that certain diagnoses, levels of 
severity of illness, or need for a particular service clearly indicate 
that admission to or residence in a NF is normally needed, or that the 
provision of specialized services is not normally needed; or
    (2) Individualized determinations based on more extensive 
individualized evaluations as required in Sec. 483.132, Sec. 483.134, 
or Sec. 483.136 (or, in the case of an individual having both IID and 
MI, Sec. Sec. 483.134 and 483.136).
    (c) Group determinations by category. Advance group determinations 
by category developed by the State mental health or intellectual 
disability authorities may be made applicable to individuals by the NF 
or other evaluator following Level I review only if existing data on the 
individual appear to be current and accurate and are sufficient to allow 
the evaluator readily to determine that the individual fits into the 
category established by the State authorities (see Sec. 483.132(c)). 
Sources of existing data on the individual that could form the basis for 
applying a categorical determination by the State authorities would be 
hospital records, physician's evaluations, election of hospice status, 
records of community mental health centers or community intellectual 
disability or developmental disability providers.
    (d) Examples of categories. Examples of categories for which the 
State mental health or intellectual disability authority may make an 
advance group determination that NF services are needed are--
    (1) Convalescent care from an acute physical illness which--
    (i) Required hospitalization; and
    (ii) Does not meet all the criteria for an exempt hospital 
discharge, which is not subject to preadmission screening, as specified 
in Sec. 483.106(b)(2).
    (2) Terminal illness, as defined for hospice purposes in Sec. 418.3 
of this chapter;
    (3) Severe physical illnesses such as coma, ventilator dependence, 
functioning at a brain stem level, or diagnoses such as chronic 
obstructive pulmonary disease, Parkinson's disease, Huntington's 
disease, amyotrophic lateral sclerosis, and congestive heart failure 
which result in a level of impairment so severe that the individual 
could not be expected to benefit from specialized services;
    (4) Provisional admissions pending further assessment in cases of 
delirium where an accurate diagnosis cannot be made until the delirium 
clears;
    (5) Provisional admissions pending further assessment in emergency 
situations requiring protective services, with placement in a nursing 
facility not to exceed 7 days; and
    (6) Very brief and finite stays of up to a fixed number of days to 
provide respite to in-home caregivers to whom the individual with MI or 
IID is expected to return following the brief NF stay.
    (e) Time limits. The State may specify time limits for categorical 
determinations that NF services are needed and in the case of paragraphs 
(d)(4), (5) and (6) of this section, must specify a time limit which is 
appropriate for provisional admissions pending further assessment and 
for emergency situations and respite care. If an individual is later 
determined to need a longer stay than the State's limit allows, the 
individual must be subjected to an annual resident review before 
continuation of the stay may be permitted and payment made for days of 
NF care beyond the State's time limit.
    (f) The State mental health and intellectual disability authorities 
may make categorical determinations that specialized services are not 
needed in the provisional, emergency and respite admission situations 
identified in Sec. 483.130(d)(4)-(6). In all other cases, except for 
Sec. 483.130(h), a determination that specialized services are not 
needed must be based on a more extensive individualized evaluation under 
Sec. 483.134 or Sec. 483.136.
    (g) Categorical determinations: No positive specialized treatment 
determinations.

[[Page 119]]

The State mental health and intellectual disability authorities must not 
make categorical determinations that specialized services are needed. 
Such a determination must be based on a more extensive individualized 
evaluation under Sec. 483.134 or Sec. 483.136 to determine the exact 
nature of the specialized services that are needed.
    (h) Categorical determinations: Dementia and IID. The State 
intellectual disability authority may make categorical determinations 
that individuals with dementia, which exists in combination with 
intellectual disability or a related condition, do not need specialized 
services.
    (i) If a State mental health or intellectual disability authority 
determines NF needs by category, it may not waive the specialized 
services determination. The appropriate State authority must also 
determine whether specialized services are needed either by category (if 
permitted) or by individualized evaluations, as specified in Sec. 
483.134 or Sec. 483.136.
    (j) Recording determinations. All determinations made by the State 
mental health and intellectual disability authority, regardless of how 
they are arrived at, must be recorded in the individual's record.
    (k) Notice of determination. The State mental health or intellectual 
disability authority must notify in writing the following entities of a 
determination made under this subpart:
    (1) The evaluated individual and his or her legal representative;
    (2) The admitting or retaining NF;
    (3) The individual or resident's attending physician; and
    (4) The discharging hospital, unless the individual is exempt from 
preadmission screening as provided for at Sec. 483.106(b)(2).
    (l) Contents of notice. Each notice of the determination made by the 
State mental health or intellectual disability authority must include--
    (1) Whether a NF level of services is needed;
    (2) Whether specialized services are needed;
    (3) The placement options that are available to the individual 
consistent with these determinations; and
    (4) The rights of the individual to appeal the determination under 
subpart E of this part.
    (m) Placement options. Except as otherwise may be provided in an 
alternative disposition plan adopted under section 1919(e)(7)(E) of the 
Act, the placement options and the required State actions are as 
follows:
    (1) Can be admitted to a NF. Any applicant for admission to a NF who 
has MI or IID and who requires the level of services provided by a NF, 
regardless of whether specialized services are also needed, may be 
admitted to a NF, if the placement is appropriate, as determined in 
Sec. 483.126. If specialized services are also needed, the State is 
responsible for providing or arranging for the provision of the 
specialized services.
    (2) Cannot be admitted to a NF. Any applicant for admission to a NF 
who has MI or IID and who does not require the level of services 
provided by a NF, regardless of whether specialized services are also 
needed, is inappropriate for NF placement and must not be admitted.
    (3) Can be considered appropriate for continued placement in a NF. 
Any NF resident with MI or IID who requires the level of services 
provided by a NF, regardless of the length of his or her stay or the 
need for specialized services, can continue to reside in the NF, if the 
placement is appropriate, as determined in Sec. 483.126.
    (4) May choose to remain in the NF even though the placement would 
otherwise be inappropriate. Any NF resident with MI or IID who does not 
require the level of services provided by a NF but does require 
specialized services and who has continuously resided in a NF for at 
least 30 consecutive months before the date of determination may choose 
to continue to reside in the facility or to receive covered services in 
an alternative appropriate institutional or noninstitutional setting. 
Wherever the resident chooses to reside, the State must meet his or her 
specialized services needs. The determination notice must provide 
information concerning how, when, and by whom the various placement 
options available to the resident will be fully explained to the 
resident.

[[Page 120]]

    (5) Cannot be considered appropriate for continued placement in a NF 
and must be discharged (short-term residents). Any NF resident with MI 
or IID who does not require the level of services provided by a NF but 
does require specialized services and who has resided in a NF for less 
than 30 consecutive months must be discharged in accordance with Sec. 
483.15(b) to an appropriate setting where the State must provide 
specialized services. The determination notice must provide information 
on how, when, and by whom the resident will be advised of discharge 
arrangements and of his/her appeal rights under both PASARR and 
discharge provisions.
    (6) Cannot be considered appropriate for continued placement in a NF 
and must be discharged (short or long-term residents). Any NF resident 
with MI or IID who does not require the level of services provided by a 
NF and does not require specialized services regardless of his or her 
length of stay, must be discharged in accordance with Sec. 483.15(b). 
The determination notice must provide information on how, when, and by 
whom the resident will be advised of discharge arrangements and of his 
or her appeal rights under both PASARR and discharge provisions.
    (n) Specialized services needed in a NF. If a determination is made 
to admit or allow to remain in a NF any individual who requires 
specialized services, the determination must be supported by assurances 
that the specialized services that are needed can and will be provided 
or arranged for by the State while the individual resides in the NF.
    (o) Record retention. The State PASARR system must maintain records 
of evaluations and determinations, regardless of whether they are 
performed categorically or individually, in order to support its 
determinations and actions and to protect the appeal rights of 
individuals subjected to PASARR; and
    (p) Tracking system. The State PASARR system must establish and 
maintain a tracking system for all individuals with MI or IID in NFs to 
ensure that appeals and future reviews are performed in accordance with 
this subpart and subpart E.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at 
81 FR 68871, Oct. 4, 2016]



Sec. 483.132  Evaluating the need for NF services and NF level of care
(PASARR/NF).

    (a) Basic rule. For each applicant for admission to a NF and each NF 
resident who has MI or IID, the evaluator must assess whether--
    (1) The individual's total needs are such that his or her needs can 
be met in an appropriate community setting;
    (2) The individual's total needs are such that they can be met only 
on an inpatient basis, which may include the option of placement in a 
home and community-based services waiver program, but for which the 
inpatient care would be required;
    (3) If inpatient care is appropriate and desired, the NF is an 
appropriate institutional setting for meeting those needs in accordance 
with Sec. 483.126; or
    (4) If the inpatient care is appropriate and desired but the NF is 
not the appropriate setting for meeting the individual's needs in 
accordance with Sec. 483.126, another setting such as an ICF/IID 
(including small, community-based facilities), an IMD providing services 
to individuals aged 65 or older, or a psychiatric hospital is an 
appropriate institutional setting for meeting those needs.
    (b) Determining appropriate placement. In determining appropriate 
placement, the evaluator must prioritize the physical and mental needs 
of the individual being evaluated, taking into account the severity of 
each condition.
    (c) Data. At a minimum, the data relied on to make a determination 
must include:
    (1) Evaluation of physical status (for example, diagnoses, date of 
onset, medical history, and prognosis);
    (2) Evaluation of mental status (for example, diagnoses, date of 
onset, medical history, likelihood that the individual may be a danger 
to himself/herself or others); and
    (3) Functional assessment (activities of daily living).
    (d) Based on the data compiled in Sec. 483.132 and, as appropriate, 
in Sec. Sec. 483.134

[[Page 121]]

and 483.136, the State mental health or intellectual disability 
authority must determine whether an NF level of services is needed.



Sec. 483.134  Evaluating whether an individual with mental illness
requires specialized services (PASARR/MI).

    (a) Purpose. The purpose of this section is to identify the minimum 
data needs and process requirements for the State mental health 
authority, which is responsible for determining whether or not the 
applicant or resident with MI, as defined in Sec. 483.102(b)(1) of this 
part, needs a specialized services program for mental illness as defined 
in Sec. 483.120.
    (b) Data. Minimum data collected must include--(1) A comprehensive 
history and physical examination of the person. The following areas must 
be included (if not previously addressed):
    (i) Complete medical history;
    (ii) Review of all body systems;
    (iii) Specific evaluation of the person's neurological system in the 
areas of motor functioning, sensory functioning, gait, deep tendon 
reflexes, cranial nerves, and abnormal reflexes; and
    (iv) In case of abnormal findings which are the basis for an NF 
placement, additional evaluations conducted by appropriate specialists.
    (2) A comprehensive drug history including current or immediate past 
use of medications that could mask symptoms or mimic mental illness.
    (3) A psychosocial evaluation of the person, including current 
living arrangements and medical and support systems.
    (4) A comprehensive psychiatric evaluation including a complete 
psychiatric history, evaluation of intellectual functioning, memory 
functioning, and orientation, description of current attitudes and overt 
behaviors, affect, suicidal or homicidal ideation, paranoia, and degree 
of reality testing (presence and content of delusions) and 
hallucinations.
    (5) A functional assessment of the individual's ability to engage in 
activities of daily living and the level of support that would be needed 
to assist the individual to perform these activities while living in the 
community. The assessment must determine whether this level of support 
can be provided to the individual in an alternative community setting or 
whether the level of support needed is such that NF placement is 
required.
    (6) The functional assessment must address the following areas: 
Self-monitoring of health status, self-administering and scheduling of 
medical treatment, including medication compliance, or both, self-
monitoring of nutritional status, handling money, dressing 
appropriately, and grooming.
    (c) Personnel requirements. (1) If the history and physical 
examination are not performed by a physician, then a physician must 
review and concur with the conclusions.
    (2) The State may designate the mental health professionals who are 
qualified--
    (i) To perform the evaluations required under paragraph (b) (2)-(6) 
of this section including the--
    (A) Comprehensive drug history;
    (B) Psychosocial evaluation;
    (C) Comprehensive psychiatric evaluation;
    (D) Functional assessment; and
    (ii) To make the determination required in paragraph (d) of this 
section.
    (d) Data interpretation. Based on the data compiled, a qualified 
mental health professional, as designated by the State, must validate 
the diagnosis of mental illness and determine whether a program of 
psychiatric specialized services is needed.



Sec. 483.136  Evaluating whether an individual with intellectual 
disability requires specialized services (PASARR/IID).

    (a) Purpose. The purpose of this section is to identify the minimum 
data needs and process requirements for the State intellectual 
disability authority to determine whether or not the applicant or 
resident with intellectual disability, as defined in Sec. 483.102(b)(3) 
of this part, needs a continuous specialized services program, which is 
analogous to active treatment, as defined in Sec. 435.1010 of this 
chapter and Sec. 483.440.
    (b) Data. Minimum data collected must include the individual's 
comprehensive history and physical examination results to identify the 
following information or, in the absence of data, must include 
information that

[[Page 122]]

permits a reviewer specifically to assess:
    (1) The individual's medical problems;
    (2) The level of impact these problems have on the individual's 
independent functioning;
    (3) All current medications used by the individual and the current 
response of the individual to any prescribed medications in the 
following drug groups:
    (i) Hypnotics,
    (ii) Antipsychotics (neuroleptics),
    (iii) Mood stabilizers and antidepressants,
    (iv) Antianxiety-sedative agents, and
    (v) Anti-Parkinson agents.
    (4) Self-monitoring of health status;
    (5) Self-administering and scheduling of medical treatments;
    (6) Self-monitoring of nutritional status;
    (7) Self-help development such as toileting, dressing, grooming, and 
eating;
    (8) Sensorimotor development, such as ambulation, positioning, 
transfer skills, gross motor dexterity, visual motor perception, fine 
motor dexterity, eye-hand coordination, and extent to which prosthetic, 
orthotic, corrective or mechanical supportive devices can improve the 
individual's functional capacity;
    (9) Speech and language (communication) development, such as 
expressive language (verbal and nonverbal), receptive language (verbal 
and nonverbal), extent to which non-oral communication systems can 
improve the individual's function capacity, auditory functioning, and 
extent to which amplification devices (for example, hearing aid) or a 
program of amplification can improve the individual's functional 
capacity;
    (10) Social development, such as interpersonal skills, recreation-
leisure skills, and relationships with others;
    (11) Academic/educational development, including functional learning 
skills;
    (12) Independent living development such as meal preparation, 
budgeting and personal finances, survival skills, mobility skills 
(orientation to the neighborhood, town, city), laundry, housekeeping, 
shopping, bedmaking, care of clothing, and orientation skills (for 
individuals with visual impairments);
    (13) Vocational development, including present vocational skills;
    (14) Affective development such as interests, and skills involved 
with expressing emotions, making judgments, and making independent 
decisions; and
    (15) The presence of identifiable maladaptive or inappropriate 
behaviors of the individual based on systematic observation (including, 
but not limited to, the frequency and intensity of identified 
maladaptive or inappropriate behaviors).
    (c) Data interpretation--(1) The State must ensure that a licensed 
psychologist identifies the intellectual functioning measurement of 
individuals with IID or a related condition.
    (2) Based on the data compiled in paragraph (b) of this section, the 
State intellectual disability authority, using appropriate personnel, as 
designated by the State, must validate that the individual has IID or is 
a person with a related condition and must determine whether specialized 
services for intellectual disability are needed. In making this 
determination, the State intellectual disability authority must make a 
qualitative judgment on the extent to which the person's status 
reflects, singly and collectively, the characteristics commonly 
associated with the need for specialized services, including--
    (i) Inability to--
    (A) Take care of the most personal care needs;
    (B) Understand simple commands;
    (C) Communicate basic needs and wants;
    (D) Be employed at a productive wage level without systematic long 
term supervision or support;
    (E) Learn new skills without aggressive and consistent training;
    (F) Apply skills learned in a training situation to other 
environments or settings without aggressive and consistent training;
    (G) Demonstrate behavior appropriate to the time, situation or place 
without direct supervision; and
    (H) Make decisions requiring informed consent without extreme 
difficulty;

[[Page 123]]

    (ii) Demonstration of severe maladaptive behavior(s) that place the 
person or others in jeopardy to health and safety; and
    (iii) Presence of other skill deficits or specialized training needs 
that necessitate the availability of trained IID personnel, 24 hours per 
day, to teach the person functional skills.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at 
71 FR 39229, July 12, 2006]



Sec. 483.138  Maintenance of services and availability of FFP.

    (a) Maintenance of services. If a NF mails a 30 day notice of its 
intent to transfer or discharge a resident, under Sec. 483.15(b) of 
this chapter, the agency may not terminate or reduce services until--
    (1) The expiration of the notice period; or
    (2) A subpart E appeal, if one has been filed, has been resolved.
    (b) Availability of FFP. FFP is available for expenditures for 
services provided to Medicaid beneficiaries during--
    (1) The 30 day notice period specified in Sec. 483.15(b) of this 
chapter; or
    (2) During the period an appeal is in progress.

[57 FR 56506, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]



 Subpart D_Requirements That Must Be Met by States and State Agencies: 
    Nurse Aide Training and Competency Evaluation, and Paid Feeding 
                               Assistants

    Source: 56 FR 48919, Sept. 26, 1991, unless otherwise noted.



Sec. 483.150  Statutory basis; Deemed meeting or waiver of
requirements.

    (a) Statutory basis. This subpart is based on sections 1819(b)(5), 
1819(f)(2), 1919(b)(5), and 1919(f)(2) of the Act, which establish 
standards for training nurse-aides and for evaluating their competency.
    (b) Deemed meeting of requirements. A nurse aide is deemed to 
satisfy the requirement of completing a training and competency 
evaluation approved by the State if he or she successfully completed a 
training and competency evaluation program before July 1, 1989 if--
    (1) The aide would have satisfied this requirement if--
    (i) At least 60 hours were substituted for 75 hours in sections 
1819(f)(2) and 1919(f)(2) of the Act, and
    (ii) The individual has made up at least the difference in the 
number of hours in the program he or she completed and 75 hours in 
supervised practical nurse aide training or in regular in-service nurse 
aide education;

or
    (2) The individual was found to be competent (whether or not by the 
State) after the completion of nurse aide training of at least 100 hours 
duration.
    (c) Waiver of requirements. A State may--
    (1) Waive the requirement for an individual to complete a competency 
evaluation program approved by the State for any individual who can 
demonstrate to the satisfaction of the State that he or she has served 
as a nurse aide at one or more facilities of the same employer in the 
state for at least 24 consecutive months before December 19, 1989; or
    (2) Deem an individual to have completed a nurse aide training and 
competency evaluation program approved by the State if the individual 
completed, before July 1, 1989, such a program that the State determines 
would have met the requirements for approval at the time it was offered.

[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991, as amended at 
60 FR 50443, Sept. 29, 1995; 75 FR 21179, Apr. 23, 2010]



Sec. 483.151  State review and approval of nurse aide training and 
competency evaluation programs.

    (a) State review and administration. (1) The State--
    (i) Must specify any nurse aide training and competency evaluation 
programs that the State approves as meeting the requirements of Sec. 
483.152 and/or competency evaluations programs that the State approves 
as meeting the requirements of Sec. 483.154; and
    (ii) May choose to offer a nurse aide training and competency 
evaluation program that meets the requirements

[[Page 124]]

of Sec. 483.152 and/or a competency evaluation program that meets the 
requirements of Sec. 483.154.
    (2) If the State does not choose to offer a nurse aide training and 
competency evaluation program or competency evaluation program, the 
State must review and approve or disapprove nurse aide training and 
competency evaluation programs and nurse aide competency evaluation 
programs upon request.
    (3) The State survey agency must in the course of all surveys, 
determine whether the nurse aide training and competency evaluation 
requirements of Sec. Sec. 483.35(c) and (d) and 483.95(g) are met.
    (b) Requirements for approval of programs. (1) Before the State 
approves a nurse aide training and competency evaluation program or 
competency evaluation program, the State must--
    (i) Determine whether the nurse aide training and competency 
evaluation program meets the course requirements of Sec. 483.152:
    (ii) Determine whether the nurse aide competency evaluation program 
meets the requirements of Sec. 483.154; and
    (iii) In all reviews other than the initial review, visit the entity 
providing the program.
    (2) The State may not approve a nurse aide training and competency 
evaluation program or competency evaluation program offered by or in a 
facility which, in the previous two years--
    (i) In the case of a skilled nursing facility, has operated under a 
waiver under section 1819(b)(4)(C)(ii)(II) of the Act;
    (ii) In the case of a nursing facility, has operated under a waiver 
under section 1919(b)(4)(C)(ii) of the Act that was granted on the basis 
of a demonstration that the facility is unable to provide nursing care 
required under section 1919(b)(4)(C)(i) of the Act for a period in 
excess of 48 hours per week;
    (iii) Has been subject to an extended (or partial extended) survey 
under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act;
    (iv) Has been assessed a civil money penalty described in section 
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the Act of not less than 
$5,000 as adjusted annually under 45 CFR part 102; or
    (v) Has been subject to a remedy described in sections 1819(h)(2)(B) 
(i) or (iii), 1819(h)(4), 1919(h)(1)(B)(i), or 1919(h)(2)(A) (i), (iii) 
or (iv) of the Act.
    (3) A State may not, until two years since the assessment of the 
penalty (or penalties) has elapsed, approve a nurse aide training and 
competency evaluation program or competency evaluation program offered 
by or in a facility that, within the two-year period beginning October 
1, 1988--
    (i) Had its participation terminated under title XVIII of the Act or 
under the State plan under title XIX of the Act;
    (ii) Was subject to a denial of payment under title XVIII or title 
XIX;
    (iii) Was assessed a civil money penalty of not less than $5,000 as 
adjusted annually under 45 CFR part 102 for deficiencies in nursing 
facility standards;
    (iv) Operated under temporary management appointed to oversee the 
operation of the facility and to ensure the health and safety of its 
residents; or
    (v) Pursuant to State action, was closed or had its residents 
transferred.
    (c) Waiver of disapproval of nurse aide training programs. (1) A 
facility may request that CMS waive the disapproval of its nurse aide 
training program when the facility has been assessed a civil money 
penalty of not less than $5,000 as adjusted annually under 45 CFR part 
102 if the civil money penalty was not related to the quality of care 
furnished to residents in the facility.
    (2) For purposes of this provision, ``quality of care furnished to 
residents'' means the direct hands-on care and treatment that a health 
care professional or direct care staff furnished to a resident.
    (3) Any waiver of disapproval of a nurse aide training program does 
not waive any requirement upon the facility to pay any civil money 
penalty.
    (d) Time frame for acting on a request for approval. The State must, 
within 90 days of the date of a request under paragraph (a)(3) of this 
section or receipt of additional information from the requester--
    (1) Advise the requester whether or not the program has been 
approved; or

[[Page 125]]

    (2) Request additional information form the requesting entity.
    (e) Duration of approval. The State may not grant approval of a 
nurse aide training and competency evaluation program for a period 
longer than 2 years. A program must notify the State and the State must 
review that program when there are substantive changes made to that 
program within the 2-year period.
    (f) Withdrawal of approval. (1) The State must withdraw approval of 
a nurse aide training and competency evaluation program or nurse aide 
competency evaluation program offered by or in a facility described in 
paragraph (b)(2) of this section.
    (2) The State may withdraw approval of a nurse aide training and 
competency evaluation program or nurse aide competency evaluation 
program if the State determines that any of the applicable requirements 
of Sec. 483.152 or Sec. 483.154 are not met by the program.
    (3) The State must withdraw approval of a nurse aide training and 
competency evaluation program or a nurse aide competency evaluation 
program if the entity providing the program refuses to permit 
unannounced visits by the State.
    (4) If a State withdraws approval of a nurse aide training and 
competency evaluation program or competency evaluation program--
    (i) The State must notify the program in writing, indicating the 
reason(s) for withdrawal of approval of the program.
    (ii) Students who have started a training and competency evaluation 
program from which approval has been withdrawn must be allowed to 
complete the course.

[56 FR 48919, Sept. 26, 1991, as amended at 75 FR 21179, Apr. 23, 2010; 
81 FR 61563, Sept. 6, 2016; 81 FR 68871, Oct. 4, 2016]



Sec. 483.152  Requirements for approval of a nurse aide training 
and competency evaluation program.

    (a) For a nurse aide training and competency evaluation program to 
be approved by the State, it must, at a minimum--
    (1) Consist of no less than 75 clock hours of training;
    (2) Include at least the subjects specified in paragraph (b) of this 
section;
    (3) Include at least 16 hours of supervised practical training. 
Supervised practical training means training in a laboratory or other 
setting in which the trainee demonstrates knowledge while performing 
tasks on an individual under the direct supervision of a registered 
nurse or a licensed practical nurse;
    (4) Ensure that--
    (i) Students do not perform any services for which they have not 
trained and been found proficient by the instructor; and
    (ii) Students who are providing services to residents are under the 
general supervision of a licensed nurse or a registered nurse;
    (5) Meet the following requirements for instructors who train nurse 
aides;
    (i) The training of nurse aides must be performed by or under the 
general supervision of a registered nurse who possesses a minimum of 2 
years of nursing experience, at least 1 year of which must be in the 
provision of long term care facility services;
    (ii) Instructors must have completed a course in teaching adults or 
have experience in teaching adults or supervising nurse aides;
    (iii) In a facility-based program, the training of nurse aides may 
be performed under the general supervision of the director of nursing 
for the facility who is prohibited from performing the actual training; 
and
    (iv) Other personnel from the health professions may supplement the 
instructor, including, but not limited to, registered nurses, licensed 
practical/vocational nurses, pharmacists, dietitians, social workers, 
sanitarians, fire safety experts, nursing home administrators, 
gerontologists, psychologists, physical and occupational therapists, 
activities specialists, speech/language/hearing therapists, and resident 
rights experts. Supplemental personnel must have at least 1 year of 
experience in their fields;
    (6) Contain competency evaluation procedures specified in Sec. 
483.154.
    (b) The curriculum of the nurse aide training program must include--

[[Page 126]]

    (1) At least a total of 16 hours of training in the following areas 
prior to any direct contact with a resident:
    (i) Communication and interpersonal skills;
    (ii) Infection control;
    (iii) Safety/emergency procedures, including the Heimlich maneuver;
    (iv) Promoting residents' independence; and
    (v) Respecting residents' rights.
    (2) Basic nursing skills;
    (i) Taking and recording vital signs;
    (ii) Measuring and recording height and weight;
    (iii) Caring for the residents' environment;
    (iv) Recognizing abnormal changes in body functioning and the 
importance of reporting such changes to a supervisor; and
    (v) Caring for residents when death is imminent.
    (3) Personal care skills, including, but not limited to--
    (i) Bathing;
    (ii) Grooming, including mouth care;
    (iii) Dressing;
    (iv) Toileting;
    (v) Assisting with eating and hydration;
    (vi) Proper feeding techniques;
    (vii) Skin care; and
    (viii) Transfers, positioning, and turning.
    (4) Mental health and social service needs:
    (i) Modifying aide's behavior in response to residents' behavior;
    (ii) Awareness of developmental tasks associated with the aging 
process;
    (iii) How to respond to resident behavior;
    (iv) Allowing the resident to make personal choices, providing and 
reinforcing other behavior consistent with the resident's dignity; and
    (v) Using the resident's family as a source of emotional support.
    (5) Care of cognitively impaired residents:
    (i) Techniques for addressing the unique needs and behaviors of 
individual with dementia (Alzheimer's and others);
    (ii) Communicating with cognitively impaired residents;
    (iii) Understanding the behavior of cognitively impaired residents;
    (iv) Appropriate responses to the behavior of cognitively impaired 
residents; and
    (v) Methods of reducing the effects of cognitive impairments.
    (6) Basic restorative services:
    (i) Training the resident in self care according to the resident's 
abilities;
    (ii) Use of assistive devices in transferring, ambulation, eating, 
and dressing;
    (iii) Maintenance of range of motion;
    (iv) Proper turning and positioning in bed and chair;
    (v) Bowel and bladder training; and
    (vi) Care and use of prosthetic and orthotic devices.
    (7) Residents' Rights.
    (i) Providing privacy and maintenance of confidentiality;
    (ii) Promoting the residents' right to make personal choices to 
accommodate their needs;
    (iii) Giving assistance in resolving grievances and disputes;
    (iv) Providing needed assistance in getting to and participating in 
resident and family groups and other activities;
    (v) Maintaining care and security of residents' personal 
possessions;
    (vi) Promoting the resident's right to be free from abuse, 
mistreatment, and neglect and the need to report any instances of such 
treatment to appropriate facility staff;
    (vii) Avoiding the need for restraints in accordance with current 
professional standards.
    (c) Prohibition of charges. (1) No nurse aide who is employed by, or 
who has received an offer of employment from, a facility on the date on 
which the aide begins a nurse aide training and competency evaluation 
program may be charged for any portion of the program (including any 
fees for textbooks or other required course materials).
    (2) If an individual who is not employed, or does not have an offer 
to be employed, as a nurse aide becomes employed by, or receives an 
offer of employment from, a facility not later than 12 months after 
completing a nurse aide training and competency evaluation program, the 
State must provide for the reimbursement of costs

[[Page 127]]

incurred in completing the program on a pro rata basis during the period 
in which the individual is employed as a nurse aide.



Sec. 483.154  Nurse aide competency evaluation.

    (a) Notification to Individual. The State must advise in advance any 
individual who takes the competency evaluation that a record of the 
successful completion of the evaluation will be included in the State's 
nurse aid registry.
    (b) Content of the competency evaluation program--(1) Written or 
oral examinations. The competency evaluation must--
    (i) Allow an aide to choose between a written and an oral 
examination;
    (ii) Address each course requirement specified in Sec. 483.152(b);
    (iii) Be developed from a pool of test questions, only a portion of 
which is used in any one examination;
    (iv) Use a system that prevents disclosure of both the pool of 
questions and the individual competency evaluations; and
    (v) If oral, must be read from a prepared text in a neutral manner.
    (2) Demonstration of skills. The skills demonstration must consist 
of a demonstration of randomly selected items drawn from a pool 
consisting of the tasks generally performed by nurse aides. This pool of 
skills must include all of the personal care skills listed in Sec. 
483.152(b)(3).
    (c) Administration of the competency evaluation. (1) The competency 
examination must be administered and evaluated only by--
    (i) The State directly; or
    (ii) A State approved entity which is neither a skilled nursing 
facility that participates in Medicare nor a nursing facility that 
participates in Medicaid.
    (2) No nurse aide who is employed by, or who has received an offer 
of employment from, a facility on the date on which the aide begins a 
nurse aide competency evaluation program may be charged for any portion 
of the program.
    (3) If an individual who is not employed, or does not have an offer 
to be employed, as a nurse aide becomes employed by, or receives an 
offer of employment from, a facility not later than 12 months after 
completing a nurse aide competency evaluation program, the State must 
provide for the reimbursement of costs incurred in completing the 
program on a pro rata basis during the period in which the individual is 
employed as a nurse aide.
    (4) The skills demonstration part of the evaluation must be--
    (i) Performed in a facility or laboratory setting comparable to the 
setting in which the individual will function as a nurse aide; and
    (ii) Administered and evaluated by a registered nurse with at least 
one year's experience in providing care for the elderly or the 
chronically ill of any age.
    (d) Facility proctoring of the competency evaluation. (1) The 
competency evaluation may, at the nurse aide's option, be conducted at 
the facility in which the nurse aide is or will be employed unless the 
facility is described in Sec. 483.151(b)(2).
    (2) The State may permit the competency evaluation to be proctored 
by facility personnel if the State finds that the procedure adopted by 
the facility assures that the competency evaluation program--
    (i) Is secure from tampering;
    (ii) Is standardized and scored by a testing, educational, or other 
organization approved by the State; and
    (iii) Requires no scoring by facility personnel.
    (3) The State must retract the right to proctor nurse aide 
competency evaluations from facilities in which the State finds any 
evidence of impropriety, including evidence of tampering by facility 
staff.
    (e) Successful completion of the competency evaluation program. (1) 
The State must establish a standard for satisfactory completion of the 
competency evaluation. To complete the competency evaluation 
successfully an individual must pass both the written or oral 
examination and the skills demonstration.
    (2) A record of successful completion of the competency evaluation 
must be included in the nurse aide registry provided in Sec. 483.156 
within 30 days of the date if the individual is found to be competent.

[[Page 128]]

    (f) Unsuccessful completion of the competency evaluation program. 
(1) If the individual does not complete the evaluation satisfactorily, 
the individual must be advised--
    (i) Of the areas which he or she; did not pass; and
    (ii) That he or she has at least three opportunities to take the 
evaluation.
    (2) The State may impose a maximum upon the number of times an 
individual upon the number of times an individual may attempt to 
complete the competency evaluation successfully, but the maximum may be 
no less than three.



Sec. 483.156  Registry of nurse aides.

    (a) Establishment of registry. The State must establish and maintain 
a registry of nurse aides that meets the requirement of this section. 
The registry--
    (1) Must include as a minimum the information contained in paragraph 
(c) of this section:
    (2) Must be sufficiently accessible to meet the needs of the public 
and health care providers promptly;
    (3) May include home health aides who have successfully completed a 
home health aide competency evaluation program approved by the State if 
home health aides are differentiated from nurse aides; and
    (4) Must provide that any response to an inquiry that includes a 
finding of abuse, neglect, or misappropriation of property also include 
any statement disputing the finding made by the nurse aide, as provided 
under paragraph (c)(1)(ix) of this section.
    (b) Registry operation. (1) The State may contract the daily 
operation and maintenance of the registry to a non-State entity. 
However, the State must maintain accountability for overall operation of 
the registry and compliance with these regulations.
    (2) Only the State survey and certification agency may place on the 
registry findings of abuse, neglect, or misappropriation of property.
    (3) The State must determine which individuals who (i) have 
successfully completed a nurse aide training and competency evaluation 
program or nurse aide competency evaluation program; (ii) have been 
deemed as meeting these requirements; or (iii) have had these 
requirements waived by the State do not qualify to remain on the 
registry because they have performed no nursing or nursing-related 
services for a period of 24 consecutive months.
    (4) The State may not impose any charges related to registration on 
individuals listed in the registry.
    (5) The State must provide information on the registry promptly.
    (c) Registry Content. (1) The registry must contain at least the 
following information on each individual who has successfully completed 
a nurse aide training and competency evaluation program which meets the 
requirements of Sec. 483.152 or a competency evaluation which meets the 
requirements of Sec. 483.154 and has been found by the State to be 
competent to function as a nurse aide or who may function as a nurse 
aide because of meeting criteria in Sec. 483.150:
    (i) The individual's full name.
    (ii) Information necessary to identify each individual;
    (iii) The date the individual became eligible for placement in the 
registry through successfully completing a nurse aide training and 
competency evaluation program or competency evaluation program or by 
meeting the requirements of Sec. 483.150; and
    (iv) The following information on any finding by the State survey 
agency of abuse, neglect, or misappropriation of property by the 
individual:
    (A) Documentation of the State's investigation, including the nature 
of the allegation and the evidence that led the State to conclude that 
the allegation was valid;
    (B) The date of the hearing, if the individual chose to have one, 
and its outcome; and
    (C) A statement by the individual disputing the allegation, if he or 
she chooses to make one; and
    (D) This information must be included in the registry within 10 
working days of the finding and must remain in the registry permanently, 
unless the finding was made in error, the individual was found not 
guilty in a court of law, or the State is notified of the individual's 
death.
    (2) The registry must remove entries for individuals who have 
performed no nursing or nursing-related services for

[[Page 129]]

a period of 24 consecutive months, unless the individual's registry 
entry includes documented findings of abuse, neglect, or 
misappropriation of property.
    (d) Disclosure of information. The State must--
    (1) Disclose all of the information in Sec. 483.156(c)(1) (iii) and 
(iv) to all requesters and may disclose additional information it deems 
necessary; and
    (2) Promptly provide individuals with all information contained in 
the registry on them when adverse findings are placed on the registry 
and upon request. Individuals on the registry must have sufficient 
opportunity to correct any misstatements or inaccuracies contained in 
the registry.

[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991]



Sec. 483.158  FFP for nurse aide training and competency evaluation.

    (a) State expenditures for nurse aide training and competency 
evaluation programs and competency evaluation programs are 
administrative costs. They are matched as indicated in Sec. 
433.15(b)(8) of this chapter.
    (b) FFP is available for State expenditures associated with nurse 
aide training and competency evaluation programs and competency 
evaluation programs only for--
    (1) Nurse aides employed by a facility;
    (2) Nurse aides who have an offer of employment from a facility;
    (3) Nurse aides who become employed by a facility not later than 12 
months after completing a nurse aide training and competency evaluation 
program or competency evaluation program; or
    (4) Nurse aides who receive an offer of employment from a facility 
not later than 12 months after completing a nurse aide training and 
competency evaluation program or competency evaluation program.



Sec. 483.160  Requirements for training of paid feeding assistants.

    (a) Minimum training course contents. A State-approved training 
course for paid feeding assistants must include, at a minimum, 8 hours 
of training in the following:
    (1) Feeding techniques.
    (2) Assistance with feeding and hydration.
    (3) Communication and interpersonal skills.
    (4) Appropriate responses to resident behavior.
    (5) Safety and emergency procedures, including the Heimlich 
maneuver.
    (6) Infection control.
    (7) Resident rights.
    (8) Recognizing changes in residents that are inconsistent with 
their normal behavior and the importance of reporting those changes to 
the supervisory nurse.
    (b) Maintenance of records. A facility must maintain a record of all 
individuals, used by the facility as feeding assistants, who have 
successfully completed the training course for paid feeding assistants.

[68 FR 55539, Sept. 26, 2003]



 Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening 
           and Annual Resident Review (PASARR) Determinations

    Source: 57 FR 56514, Nov. 30, 1992, unless otherwise noted.



Sec. 483.200  Statutory basis.

    This subpart is based on sections 1819(e)(3) and (f)(3) and 
1919(e)(3) and (f)(3) of the Act, which require States to make 
available, to individuals who are discharged or transferred from SNFs or 
NFs, an appeals process that complies with guidelines issued by the 
Secretary.

[60 FR 50443, Sept. 29, 1995]



Sec. 483.202  Definitions.

    For purposes of this subpart and subparts B and C--
    Discharge means movement from an entity that participates in 
Medicare as a skilled nursing facility, a Medicare certified distinct 
part, an entity that participates in Medicaid as a nursing facility, or 
a Medicaid certified distinct part to a noninstitutional setting when 
the discharging facility ceases to be legally responsible for the care 
of the resident.

[[Page 130]]

    Individual means an individual or any legal representative of the 
individual.
    Resident means a resident of a SNF or NF or any legal representative 
of the resident.
    Transfer means movement from an entity that participates in Medicare 
as a skilled nursing facility, a Medicare certified distinct part, an 
entity that participates in Medicaid as a nursing facility or a Medicaid 
certified distinct part to another institutional setting when the legal 
responsibility for the care of the resident changes from the 
transferring facility to the receiving facility.



Sec. 483.204  Provision of a hearing and appeal system.

    (a) Each State must provide a system for:
    (1) A resident of a SNF or a NF to appeal a notice from the SNF or 
NF of intent to discharge or transfer the resident; and
    (2) An individual who has been adversely affected by any PASARR 
determination made by the State in the context of either a preadmission 
screening or an annual resident review under subpart C of part 483 to 
appeal that determination.
    (b) The State must provide an appeals system that meets the 
requirements of this subpart, Sec. 483.15(h), and part 431 subpart E of 
this chapter.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at 
81 FR 68871, Oct. 4, 2016]



Sec. 483.206  Transfers, discharges and relocations subject to appeal.

    (a) ``Facility'' means a certified entity, either a Medicare SNF or 
a Medicaid NF (See Sec. 483.5).
    (b) A resident has appeal rights when he or she is transferred 
from--
    (1) A certified bed into a noncertified bed; and
    (2) A bed in a certified entity to a bed in an entity which is 
certified as a different provider.
    (c) A resident has no appeal rights when he or she is moved from one 
bed in the certified entity to another bed in the same certified entity.

[57 FR 56514, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]



 Subpart F_Requirements That Must be Met by States and State Agencies, 
                           Resident Assessment



Sec. 483.315  Specification of resident assessment instrument.

    (a) Statutory basis. Sections 1819(e)(5) and 1919(e)(5) of the Act 
require that a State specify the resident assessment instrument (RAI) to 
be used by long term care facilities in the State when conducting 
initial and periodic assessments of each resident's functional capacity, 
in accordance with Sec. 483.20.
    (b) State options in specifying an RAI. The RAI that the State 
specifies must be one of the following:
    (1) The instrument designated by CMS.
    (2) An alternate instrument specified by the State and approved by 
CMS, using the criteria specified in the State Operations Manual issued 
by CMS (CMS Pub. 7) which is available for purchase through the National 
Technical Information Service, 5285 Port Royal Rd., Springfield, VA 
22151.
    (c) State requirements in specifying an RAI. (1) Within 30 days 
after CMS notifies the State of the CMS-designated RAI or changes to it, 
the State must do one of the following:
    (i) Specify the CMS-designated RAI.
    (ii) Notify CMS of its intent to specify an alternate instrument.
    (2) Within 60 days after receiving CMS approval of an alternate RAI, 
the State must specify the RAI for use by all long term care facilities 
participating in the Medicare and Medicaid programs.
    (3) After specifying an instrument, the State must provide periodic 
educational programs for facility staff to assist with implementation of 
the RAI.
    (4) A State must audit implementation of the RAI through the survey 
process.
    (5) A State must obtain approval from CMS before making any 
modifications to its RAI.
    (6) A State must adopt revisions to the RAI that are specified by 
CMS.
    (d) CMS-designated RAI. The CMS-designated RAI is published in the 
State Operations Manual issued by CMS (CMS Pub. 7), as updated 
periodically, and consists of the following:

[[Page 131]]

    (1) The minimum data set (MDS) and common definitions.
    (2) Care area assessment (CAA) guidelines and care area triggers 
(CATs) that are necessary to accurately assess residents, established by 
CMS.
    (3) The quarterly review, based on a subset of the MDS specified by 
CMS.
    (4) The requirements for use of the RAI that appear at Sec. 483.20.
    (e) Minimum data set (MDS). The MDS includes assessment in the areas 
specified in Sec. 483.20(b)(i) through (xviii) of this chapter, and as 
defined in the RAI manual published in the State Operations Manual 
issued by CMS (CMS Pub. 100-07).
    (f) [Reserved]
    (g) Criteria for CMS approval of alternate instrument. To receive 
CMS approval, a State's alternate instrument must use the standardized 
format, organization, item labels and definitions, and instructions 
specified by CMS in the latest issuance of the State Operations Manual 
issued by CMS (CMS Pub. 7).
    (h) State MDS system and database requirements. As part of facility 
agency responsibilities, the State Survey Agency must:
    (1) Support and maintain the CMS State system and database.
    (2) Specify to a facility the method of transmission of data, and 
instruct the facility on this method.
    (3) Upon receipt of facility data from CMS, ensure that a facility 
resolves errors.
    (4) Analyze data and generate reports, as specified by CMS.
    (i) State identification of agency that receives RAI data. The State 
must identify the component agency that receives RAI data, and ensure 
that this agency restricts access to the data except for the following:
    (1) Reports that contain no resident-identifiable data.
    (2) Transmission of reports to CMS.
    (3) Transmission of data and reports to the State agency that 
conducts surveys to ensure compliance with Medicare and Medicaid 
participation requirements, for purposes related to this function.
    (4) Transmission of data and reports to the State Medicaid agency 
for purposes directly related to the administration of the State 
Medicaid plan.
    (5) Transmission of data and reports to other entities only when 
authorized as a routine use by CMS.
    (j) Resident-identifiable data. (1) The State may not release 
information that is resident-identifiable to the public.
    (2) The State may not release RAI data that is resident-identifiable 
except in accordance with a written agreement under which the 
beneficiary agrees to be bound by the restrictions described in 
paragraph (i) of this section.

[62 FR 67212, Dec. 23, 1997, as amended at 74 FR 40363, Aug. 11, 2009]



    Subpart G_Condition of Participation for the Use of Restraint or 
  Seclusion in Psychiatric Residential Treatment Facilities Providing 
       Inpatient Psychiatric Services for Individuals Under Age 21

    Source: 66 FR 7161, Jan. 22, 2001, unless otherwise noted.



Sec. 483.350  Basis and scope.

    (a) Statutory basis. Sections 1905(a)(16) and (h) of the Act provide 
that inpatient psychiatric services for individuals under age 21 include 
only inpatient services that are provided in an institution (or distinct 
part thereof) that is a psychiatric hospital as defined in section 
1861(f) of the Act or in another inpatient setting that the Secretary 
has specified in regulations. Additionally, the Children's Health Act of 
2000 (Pub. L. 106-310) imposes procedural reporting and training 
requirements regarding the use of restraints and involuntary seclusion 
in facilities, specifically including facilities that provide inpatient 
psychiatric services for children under the age of 21 as defined by 
sections 1905(a)(16) and (h) of the Act.
    (b) Scope. This subpart imposes requirements regarding the use of 
restraint or seclusion in psychiatric residential treatment facilities, 
that are not hospitals, providing inpatient psychiatric services to 
individuals under age 21.

[[Page 132]]



Sec. 483.352  Definitions.

    For purposes of this subpart, the following definitions apply:
    Drug used as a restraint means any drug that--
    (1) Is administered to manage a resident's behavior in a way that 
reduces the safety risk to the resident or others;
    (2) Has the temporary effect of restricting the resident's freedom 
of movement; and
    (3) Is not a standard treatment for the resident's medical or 
psychiatric condition.
    Emergency safety intervention means the use of restraint or 
seclusion as an immediate response to an emergency safety situation.
    Emergency safety situation means unanticipated resident behavior 
that places the resident or others at serious threat of violence or 
injury if no intervention occurs and that calls for an emergency safety 
intervention as defined in this section.
    Mechanical restraint means any device attached or adjacent to the 
resident's body that he or she cannot easily remove that restricts 
freedom of movement or normal access to his or her body.
    Minor means a minor as defined under State law and, for the purpose 
of this subpart, includes a resident who has been declared legally 
incompetent by the applicable State court.
    Personal restraint means the application of physical force without 
the use of any device, for the purposes of restraining the free movement 
of a resident's body. The term personal restraint does not include 
briefly holding without undue force a resident in order to calm or 
comfort him or her, or holding a resident's hand to safely escort a 
resident from one area to another.
    Psychiatric Residential Treatment Facility means a facility other 
than a hospital, that provides psychiatric services, as described in 
subpart D of part 441 of this chapter, to individuals under age 21, in 
an inpatient setting.
    Restraint means a ``personal restraint,'' ``mechanical restraint,'' 
or ``drug used as a restraint'' as defined in this section.
    Seclusion means the involuntary confinement of a resident alone in a 
room or an area from which the resident is physically prevented from 
leaving.
    Serious injury means any significant impairment of the physical 
condition of the resident as determined by qualified medical personnel. 
This includes, but is not limited to, burns, lacerations, bone 
fractures, substantial hematoma, and injuries to internal organs, 
whether self-inflicted or inflicted by someone else.
    Staff means those individuals with responsibility for managing a 
resident's health or participating in an emergency safety intervention 
and who are employed by the facility on a full-time, part-time, or 
contract basis.
    Time out means the restriction of a resident for a period of time to 
a designated area from which the resident is not physically prevented 
from leaving, for the purpose of providing the resident an opportunity 
to regain self-control.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28116, May 22, 2001]



Sec. 483.354  General requirements for psychiatric residential
treatment facilities.

    A psychiatric residential treatment facility must meet the 
requirements in Sec. 441.151 through Sec. 441.182 of this chapter.



Sec. 483.356  Protection of residents.

    (a) Restraint and seclusion policy for the protection of residents. 
(1) Each resident has the right to be free from restraint or seclusion, 
of any form, used as a means of coercion, discipline, convenience, or 
retaliation.
    (2) An order for restraint or seclusion must not be written as a 
standing order or on an as-needed basis.
    (3) Restraint or seclusion must not result in harm or injury to the 
resident and must be used only--
    (i) To ensure the safety of the resident or others during an 
emergency safety situation; and
    (ii) Until the emergency safety situation has ceased and the 
resident's safety and the safety of others can be ensured, even if the 
restraint or seclusion order has not expired.
    (4) Restraint and seclusion must not be used simultaneously.

[[Page 133]]

    (b) Emergency safety intervention. An emergency safety intervention 
must be performed in a manner that is safe, proportionate, and 
appropriate to the severity of the behavior, and the resident's 
chronological and developmental age; size; gender; physical, medical, 
and psychiatric condition; and personal history (including any history 
of physical or sexual abuse).
    (c) Notification of facility policy. At admission, the facility 
must--
    (1) Inform both the incoming resident and, in the case of a minor, 
the resident's parent(s) or legal guardian(s) of the facility's policy 
regarding the use of restraint or seclusion during an emergency safety 
situation that may occur while the resident is in the program;
    (2) Communicate its restraint and seclusion policy in a language 
that the resident, or his or her parent(s) or legal guardian(s) 
understands (including American Sign Language, if appropriate) and when 
necessary, the facility must provide interpreters or translators;
    (3) Obtain an acknowledgment, in writing, from the resident, or in 
the case of a minor, from the parent(s) or legal guardian(s) that he or 
she has been informed of the facility's policy on the use of restraint 
or seclusion during an emergency safety situation. Staff must file this 
acknowledgment in the resident's record; and
    (4) Provide a copy of the facility policy to the resident and in the 
case of a minor, to the resident's parent(s) or legal guardian(s).
    (d) Contact information. The facility's policy must provide contact 
information, including the phone number and mailing address, for the 
appropriate State Protection and Advocacy organization.



Sec. 483.358  Orders for the use of restraint or seclusion.

    (a) Orders for restraint or seclusion must be by a physician, or 
other licensed practitioner permitted by the State and the facility to 
order restraint or seclusion and trained in the use of emergency safety 
interventions. Federal regulations at 42 CFR 441.151 require that 
inpatient psychiatric services for beneficiaries under age 21 be 
provided under the direction of a physician.
    (b) If the resident's treatment team physician is available, only he 
or she can order restraint or seclusion.
    (c) A physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion must order the 
least restrictive emergency safety intervention that is most likely to 
be effective in resolving the emergency safety situation based on 
consultation with staff.
    (d) If the order for restraint or seclusion is verbal, the verbal 
order must be received by a registered nurse or other licensed staff 
such as a licensed practical nurse, while the emergency safety 
intervention is being initiated by staff or immediately after the 
emergency safety situation ends. The physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion must verify the verbal order in a signed written form in 
the resident's record. The physician or other licensed practitioner 
permitted by the state and the facility to order restraint or seclusion 
must be available to staff for consultation, at least by telephone, 
throughout the period of the emergency safety intervention.
    (e) Each order for restraint or seclusion must:
    (1) Be limited to no longer than the duration of the emergency 
safety situation; and
    (2) Under no circumstances exceed 4 hours for residents ages 18 to 
21; 2 hours for residents ages 9 to 17; or 1 hour for residents under 
age 9.
    (f) Within 1 hour of the initiation of the emergency safety 
intervention a physician, or other licensed practitioner trained in the 
use of emergency safety interventions and permitted by the state and the 
facility to assess the physical and psychological well being of 
residents, must conduct a face-to-face assessment of the physical and 
psychological well being of the resident, including but not limited to--
    (1) The resident's physical and psychological status;
    (2) The resident's behavior;
    (3) The appropriateness of the intervention measures; and
    (4) Any complications resulting from the intervention.

[[Page 134]]

    (g) Each order for restraint or seclusion must include--
    (1) The name of the ordering physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion;
    (2) The date and time the order was obtained; and
    (3) The emergency safety intervention ordered, including the length 
of time for which the physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion authorized 
its use.
    (h) Staff must document the intervention in the resident's record. 
That documentation must be completed by the end of the shift in which 
the intervention occurs. If the intervention does not end during the 
shift in which it began, documentation must be completed during the 
shift in which it ends. Documentation must include all of the following:
    (1) Each order for restraint or seclusion as required in paragraph 
(g) of this section.
    (2) The time the emergency safety intervention actually began and 
ended.
    (3) The time and results of the 1-hour assessment required in 
paragraph (f) of this section.
    (4) The emergency safety situation that required the resident to be 
restrained or put in seclusion.
    (5) The name of staff involved in the emergency safety intervention.
    (i) The facility must maintain a record of each emergency safety 
situation, the interventions used, and their outcomes.
    (j) The physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion must sign the 
restraint or seclusion order in the resident's record as soon as 
possible.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28116, May 22, 2001]



Sec. 483.360  Consultation with treatment team physician.

    If a physician or other licensed practitioner permitted by the state 
and the facility to order restraint or seclusion orders the use of 
restraint or seclusion, that person must contact the resident's 
treatment team physician, unless the ordering physician is in fact the 
resident's treatment team physician. The person ordering the use of 
restraint or seclusion must--
    (a) Consult with the resident's treatment team physician as soon as 
possible and inform the team physician of the emergency safety situation 
that required the resident to be restrained or placed in seclusion; and
    (b) Document in the resident's record the date and time the team 
physician was consulted.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]



Sec. 483.362  Monitoring of the resident in and immediately after
restraint.

    (a) Clinical staff trained in the use of emergency safety 
interventions must be physically present, continually assessing and 
monitoring the physical and psychological well-being of the resident and 
the safe use of restraint throughout the duration of the emergency 
safety intervention.
    (b) If the emergency safety situation continues beyond the time 
limit of the order for the use of restraint, a registered nurse or other 
licensed staff, such as a licensed practical nurse, must immediately 
contact the ordering physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion to receive 
further instructions.
    (c) A physician, or other licensed practitioner permitted by the 
state and the facility to evaluate the resident's well-being and trained 
in the use of emergency safety interventions, must evaluate the 
resident's well-being immediately after the restraint is removed.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]



Sec. 483.364  Monitoring of the resident in and immediately after
seclusion.

    (a) Clinical staff, trained in the use of emergency safety 
interventions, must be physically present in or immediately outside the 
seclusion room, continually assessing, monitoring, and evaluating the 
physical and psychological well-being of the resident in seclusion. 
Video monitoring does not meet this requirement.
    (b) A room used for seclusion must--

[[Page 135]]

    (1) Allow staff full view of the resident in all areas of the room; 
and
    (2) Be free of potentially hazardous conditions such as unprotected 
light fixtures and electrical outlets.
    (c) If the emergency safety situation continues beyond the time 
limit of the order for the use of seclusion, a registered nurse or other 
licensed staff, such as a licensed practical nurse, must immediately 
contact the ordering physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion to receive 
further instructions.
    (d) A physician, or other licensed practitioner permitted by the 
state and the facility to evaluate the resident's well-being and trained 
in the use of emergency safety interventions, must evaluate the 
resident's well-being immediately after the resident is removed from 
seclusion.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]



Sec. 483.366  Notification of parent(s) or legal guardian(s).

    If the resident is a minor as defined in this subpart:
    (a) The facility must notify the parent(s) or legal guardian(s) of 
the resident who has been restrained or placed in seclusion as soon as 
possible after the initiation of each emergency safety intervention.
    (b) The facility must document in the resident's record that the 
parent(s) or legal guardian(s) has been notified of the emergency safety 
intervention, including the date and time of notification and the name 
of the staff person providing the notification.



Sec. 483.368  Application of time out.

    (a) A resident in time out must never be physically prevented from 
leaving the time out area.
    (b) Time out may take place away from the area of activity or from 
other residents, such as in the resident's room (exclusionary), or in 
the area of activity or other residents (inclusionary).
    (c) Staff must monitor the resident while he or she is in time out.



Sec. 483.370  Postintervention debriefings.

    (a) Within 24 hours after the use of restraint or seclusion, staff 
involved in an emergency safety intervention and the resident must have 
a face-to-face discussion. This discussion must include all staff 
involved in the intervention except when the presence of a particular 
staff person may jeopardize the well-being of the resident. Other staff 
and the resident's parent(s) or legal guardian(s) may participate in the 
disussion when it is deemed appropriate by the facility. The facility 
must conduct such discussion in a language that is understood by the 
resident's parent(s) or legal guardian(s). The discussion must provide 
both the resident and staff the opportunity to discuss the circumstances 
resulting in the use of restraint or seclusion and strategies to be used 
by the staff, the resident, or others that could prevent the future use 
of restraint or seclusion.
    (b) Within 24 hours after the use of restraint or seclusion, all 
staff involved in the emergency safety intervention, and appropriate 
supervisory and administrative staff, must conduct a debriefing session 
that includes, at a minimum, a review and discussion of--
    (1) The emergency safety situation that required the intervention, 
including a discussion of the precipitating factors that led up to the 
intervention;
    (2) Alternative techniques that might have prevented the use of the 
restraint or seclusion;
    (3) The procedures, if any, that staff are to implement to prevent 
any recurrence of the use of restraint or seclusion; and
    (4) The outcome of the intervention, including any injuries that may 
have resulted from the use of restraint or seclusion.
    (c) Staff must document in the resident's record that both 
debriefing sessions took place and must include in that documentation 
the names of staff who were present for the debriefing, names of staff 
that were excused from the debriefing, and any changes to the resident's 
treatment plan that result from the debriefings.

[[Page 136]]



Sec. 483.372  Medical treatment for injuries resulting from an
emergency safety intervention.

    (a) Staff must immediately obtain medical treatment from qualified 
medical personnel for a resident injured as a result of an emergency 
safety intervention.
    (b) The psychiatric residential treatment facility must have 
affiliations or written transfer agreements in effect with one or more 
hospitals approved for participation under the Medicaid program that 
reasonably ensure that--
    (1) A resident will be transferred from the facility to a hospital 
and admitted in a timely manner when a transfer is medically necessary 
for medical care or acute psychiatric care;
    (2) Medical and other information needed for care of the resident in 
light of such a transfer, will be exchanged between the institutions in 
accordance with State medical privacy law, including any information 
needed to determine whether the appropriate care can be provided in a 
less restrictive setting; and
    (3) Services are available to each resident 24 hours a day, 7 days a 
week.
    (c) Staff must document in the resident's record, all injuries that 
occur as a result of an emergency safety intervention, including 
injuries to staff resulting from that intervention.
    (d) Staff involved in an emergency safety intervention that results 
in an injury to a resident or staff must meet with supervisory staff and 
evaluate the circumstances that caused the injury and develop a plan to 
prevent future injuries.



Sec. 483.374  Facility reporting.

    (a) Attestation of facility compliance. Each psychiatric residential 
treatment facility that provides inpatient psychiatric services to 
individuals under age 21 must attest, in writing, that the facility is 
in compliance with CMS's standards governing the use of restraint and 
seclusion. This attestation must be signed by the facility director.
    (1) A facility with a current provider agreement with the Medicaid 
agency must provide its attestation to the State Medicaid agency by July 
21, 2001.
    (2) A facility enrolling as a Medicaid provider must meet this 
requirement at the time it executes a provider agreement with the 
Medicaid agency.
    (b) Reporting of serious occurrences. The facility must report each 
serious occurrence to both the State Medicaid agency and, unless 
prohibited by State law, the State-designated Protection and Advocacy 
system. Serious occurrences that must be reported include a resident's 
death, a serious injury to a resident as defined in Sec. 483.352 of 
this part, and a resident's suicide attempt.
    (1) Staff must report any serious occurrence involving a resident to 
both the State Medicaid agency and the State-designated Protection and 
Advocacy system by no later than close of business the next business day 
after a serious occurrence. The report must include the name of the 
resident involved in the serious occurrence, a description of the 
occurrence, and the name, street address, and telephone number of the 
facility.
    (2) In the case of a minor, the facility must notify the resident's 
parent(s) or legal guardian(s) as soon as possible, and in no case later 
than 24 hours after the serious occurrence.
    (3) Staff must document in the resident's record that the serious 
occurrence was reported to both the State Medicaid agency and the State-
designated Protection and Advocacy system, including the name of the 
person to whom the incident was reported. A copy of the report must be 
maintained in the resident's record, as well as in the incident and 
accident report logs kept by the facility.
    (c) Reporting of deaths. In addition to the reporting requirements 
contained in paragraph (b) of this section, facilities must report the 
death of any resident to the Centers for Medicare & Medicaid Services 
(CMS) regional office.
    (1) Staff must report the death of any resident to the CMS regional 
office by no later than close of business the next business day after 
the resident's death.
    (2) Staff must document in the resident's record that the death was 
reported to the CMS regional office.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]

[[Page 137]]



Sec. 483.376  Education and training.

    (a) The facility must require staff to have ongoing education, 
training, and demonstrated knowledge of--
    (1) Techniques to identify staff and resident behaviors, events, and 
environmental factors that may trigger emergency safety situations;
    (2) The use of nonphysical intervention skills, such as de-
escalation, mediation conflict resolution, active listening, and verbal 
and observational methods, to prevent emergency safety situations; and
    (3) The safe use of restraint and the safe use of seclusion, 
including the ability to recognize and respond to signs of physical 
distress in residents who are restrained or in seclusion.
    (b) Certification in the use of cardiopulmonary resuscitation, 
including periodic recertification, is required.
    (c) Individuals who are qualified by education, training, and 
experience must provide staff training.
    (d) Staff training must include training exercises in which staff 
members successfully demonstrate in practice the techniques they have 
learned for managing emergency safety situations.
    (e) Staff must be trained and demonstrate competency before 
participating in an emergency safety intervention.
    (f) Staff must demonstrate their competencies as specified in 
paragraph (a) of this section on a semiannual basis and their 
competencies as specified in paragraph (b) of this section on an annual 
basis.
    (g) The facility must document in the staff personnel records that 
the training and demonstration of competency were successfully 
completed. Documentation must include the date training was completed 
and the name of persons certifying the completion of training.
    (h) All training programs and materials used by the facility must be 
available for review by CMS, the State Medicaid agency, and the State 
survey agency.

Subpart H [Reserved]



 Subpart I_Conditions of Participation for Intermediate Care Facilities 
             for Individuals with Intellectual Disabilities

    Source: 53 FR 20496, June 3, 1988, unless otherwise noted. 
Redesignated at 56 FR 48918, Sept. 26, 1991.



Sec. 483.400  Basis and purpose.

    This subpart implements section 1905 (c) and (d) of the Act which 
gives the Secretary authority to prescribe regulations for intermediate 
care facility services in facilities for individuals with intellectual 
disabilities or persons with related conditions.



Sec. 483.405  Relationship to other HHS regulations.

    In addition to compliance with the regulations set forth in this 
subpart, facilities are obliged to meet the applicable provisions of 
other HHS regulations, including but not limited to those pertaining to 
nondiscrimination on the basis of race, color, or national origin (45 
CFR part 80), nondiscrimination on the basis of handicap (45 CFR part 
84), nondiscrimination on the basis of age (45 CFR part 91), protection 
of human subjects of research (45 CFR part 46), and fraud and abuse (42 
CFR part 455). Although those regulations are not in themselves 
considered conditions of participation under this part, their violation 
may result in the termination or suspension of, or the refusal to grant 
or continue, Federal financial assistance.



Sec. 483.410  Condition of participation: Governing body and 
management.

    (a) Standard: Governing body. The facility must identify an 
individual or individuals to constitute the governing body of the 
facility. The governing body must--
    (1) Exercise general policy, budget, and operating direction over 
the facility;
    (2) Set the qualifications (in addition to those already set by 
State law, if any) for the administrator of the facility; and
    (3) Appoint the administrator of the facility.
    (b) Standard: Compliance with Federal, State, and local laws. The 
facility must

[[Page 138]]

be in compliance with all applicable provisions of Federal, State and 
local laws, regulations and codes pertaining to health, safety, and 
sanitation.
    (c) Standard: Client records. (1) The facility must develop and 
maintain a recordkeeping system that includes a separate record for each 
client and that documents the client's health care, active treatment, 
social information, and protection of the client's rights.
    (2) The facility must keep confidential all information contained in 
the clients' records, regardless of the form or storage method of the 
records.
    (3) The facility must develop and implement policies and procedures 
governing the release of any client information, including consents 
necessary from the client, or parents (if the client is a minor) or 
legal guardian.
    (4) Any individual who makes an entry in a client's record must make 
it legibly, date it, and sign it.
    (5) The facility must provide a legend to explain any symbol or 
abbreviation used in a client's record.
    (6) The facility must provide each identified residential living 
unit with appropriate aspects of each client's record.
    (d) Standard: Services provided under agreements with outside 
sources. (1) If a service required under this subpart is not provided 
directly, the facility must have a written agreement with an outside 
program, resource, or service to furnish the necessary service, 
including emergency and other health care.
    (2) The agreement must--
    (i) Contain the responsibilities, functions, objectives, and other 
terms agreed to by both parties; and
    (ii) Provide that the facility is responsible for assuring that the 
outside services meet the standards for quality of services contained in 
this subpart.
    (3) The facility must assure that outside services meet the needs of 
each client.
    (4) If living quarters are not provided in a facility owned by the 
ICF/IID, the ICF/IID remains directly responsible for the standards 
relating to physical environment that are specified in Sec. 483.470 (a) 
through (g), (j) and (k).
    (e) Standard: Licensure. The facility must be licensed under 
applicable State and local law.

[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991, 
and amended at 57 FR 43925, Sept. 23, 1992]



Sec. 483.420  Condition of participation: Client protections.

    (a) Standard: Protection of clients' rights. The facility must 
ensure the rights of all clients. Therefore, the facility must--
    (1) Inform each client, parent (if the client is a minor), or legal 
guardian, of the client's rights and the rules of the facility;
    (2) Inform each client, parent (if the client is a minor), or legal 
guardian, of the client's medical condition, developmental and 
behavioral status, attendant risks of treatment, and of the right to 
refuse treatment;
    (3) Allow and encourage individual clients to exercise their rights 
as clients of the facility, and as citizens of the United States, 
including the right to file complaints, and the right to due process;
    (4) Allow individual clients to manage their financial affairs and 
teach them to do so to the extent of their capabilities;
    (5) Ensure that clients are not subjected to physical, verbal, 
sexual or psychological abuse or punishment;
    (6) Ensure that clients are free from unnecessary drugs and physical 
restraints and are provided active treatment to reduce dependency on 
drugs and physical restraints;
    (7) Provide each client with the opportunity for personal privacy 
and ensure privacy during treatment and care of personal needs;
    (8) Ensure that clients are not compelled to perform services for 
the facility and ensure that clients who do work for the facility are 
compensated for their efforts at prevailing wages and commensurate with 
their abilities;
    (9) Ensure clients the opportunity to communicate, associate and 
meet privately with individuals of their choice, and to send and receive 
unopened mail;
    (10) Ensure that clients have access to telephones with privacy for 
incoming and outgoing local and long distance calls except as 
contraindicated

[[Page 139]]

by factors identified within their individual program plans;
    (11) Ensure clients the opportunity to participate in social, 
religious, and community group activities;
    (12) Ensure that clients have the right to retain and use 
appropriate personal possessions and clothing, and ensure that each 
client is dressed in his or her own clothing each day; and
    (13) Permit a husband and wife who both reside in the facility to 
share a room.
    (b) Standard: Client finances. (1) The facility must establish and 
maintain a system that--
    (i) Assures a full and complete accounting of clients' personal 
funds entrusted to the facility on behalf of clients; and
    (ii) Precludes any commingling of client funds with facility funds 
or with the funds of any person other than another client.
    (2) The client's financial record must be available on request to 
the client, parents (if the client is a minor) or legal guardian.
    (c) Standard: Communication with clients, parents, and guardians. 
The facility must--
    (1) Promote participation of parents (if the client is a minor) and 
legal guardians in the process of providing active treatment to a client 
unless their participation is unobtainable or inappropriate;
    (2) Answer communications from clients' families and friends 
promptly and appropriately;
    (3) Promote visits by individuals with a relationship to the client 
(such as family, close friends, legal guardians and advocates) at any 
reasonable hour, without prior notice, consistent with the right of that 
client's and other clients' privacy, unless the interdisciplinary team 
determines that the visit would not be appropriate;
    (4) Promote visits by parents or guardians to any area of the 
facility that provides direct client care services to the client, 
consistent with the right of that client's and other clients' privacy;
    (5) Promote frequent and informal leaves from the facility for 
visits, trips, or vacations; and
    (6) Notify promptly the client's parents or guardian of any 
significant incidents, or changes in the client's condition including, 
but not limited to, serious illness, accident, death, abuse, or 
unauthorized absence.
    (d) Standard: Staff treatment of clients. (1) The facility must 
develop and implement written policies and procedures that prohibit 
mistreatment, neglect or abuse of the client.
    (i) Staff of the facility must not use physical, verbal, sexual or 
psychological abuse or punishment.
    (ii) Staff must not punish a client by withholding food or hydration 
that contributes to a nutritionally adequate diet.
    (iii) The facility must prohibit the employment of individuals with 
a conviction or prior employment history of child or client abuse, 
neglect or mistreatment.
    (2) The facility must ensure that all allegations of mistreatment, 
neglect or abuse, as well as injuries of unknown source, are reported 
immediately to the administrator or to other officials in accordance 
with State law through established procedures.
    (3) The facility must have evidence that all alleged violations are 
thoroughly investigated and must prevent further potential abuse while 
the investigation is in progress.
    (4) The results of all investigations must be reported to the 
administrator or designated representative or to other officials in 
accordance with State law within five working days of the incident and, 
if the alleged violation is verified, appropriate corrective action must 
be taken.



Sec. 483.430  Condition of participation: Facility staffing.

    (a) Standard: Qualified intellectual disability professional. Each 
client's active treatment program must be integrated, coordinated and 
monitored by a qualified intellectual disability professional who--
    (1) Has at least one year of experience working directly with 
persons with intellectual disability or other developmental 
disabilities; and
    (2) Is one of the following:
    (i) A doctor of medicine or osteopathy.

[[Page 140]]

    (ii) A registered nurse.
    (iii) An individual who holds at least a bachelor's degree in a 
professional category specified in paragraph (b)(5) of this section.
    (b) Standard: Professional program services. (1) Each client must 
receive the professional program services needed to implement the active 
treatment program defined by each client's individual program plan. 
Professional program staff must work directly with clients and with 
paraprofessional, nonprofessional and other professional program staff 
who work with clients.
    (2) The facility must have available enough qualified professional 
staff to carry out and monitor the various professional interventions in 
accordance with the stated goals and objectives of every individual 
program plan.
    (3) Professional program staff must participate as members of the 
interdisciplinary team in relevant aspects of the active treatment 
process.
    (4) Professional program staff must participate in on-going staff 
development and training in both formal and informal settings with other 
professional, paraprofessional, and nonprofessional staff members.
    (5) Professional program staff must be licensed, certified, or 
registered, as applicable, to provide professional services by the State 
in which he or she practices. Those professional program staff who do 
not fall under the jurisdiction of State licensure, certification, or 
registration requirements, specified in Sec. 483.410(b), must meet the 
following qualifications:
    (i) To be designated as an occupational therapist, an individual 
must be eligible for certification as an occupational therapist by the 
American Occupational Therapy Association or another comparable body.
    (ii) To be designated as an occupational therapy assistant, an 
individual must be eligible for certification as a certified 
occupational therapy assistant by the American Occupational Therapy 
Association or another comparable body.
    (iii) To be designated as a physical therapist, an individual must 
be eligible for certification as a physical therapist by the American 
Physical Therapy Association or another comparable body.
    (iv) To be designated as a physical therapy assistant, an individual 
must be eligible for registration by the American Physical Therapy 
Association or be a graduate of a two year college-level program 
approved by the American Physical Therapy Association or another 
comparable body.
    (v) To be designated as a psychologist, an individual must have at 
least a master's degree in psychology from an accredited school.
    (vi) To be designated as a social worker, an individual must--
    (A) Hold a graduate degree from a school of social work accredited 
or approved by the Council on Social Work Education or another 
comparable body; or
    (B) Hold a Bachelor of Social Work degree from a college or 
university accredited or approved by the Council on Social Work 
Education or another comparable body.
    (vii) To be designated as a speech-language pathologist or 
audiologist, an individual must--
    (A) Be eligible for a Certificate of Clinical Competence in Speech-
Language Pathology or Audiology granted by the American Speech-Language-
Hearing Association or another comparable body; or
    (B) Meet the educational requirements for certification and be in 
the process of accumulating the supervised experience required for 
certification.
    (viii) To be designated as a professional recreation staff member, 
an individual must have a bachelor's degree in recreation or in a 
specialty area such as art, dance, music or physical education.
    (ix) To be designated as a professional dietitian, an individual 
must be eligible for registration by the American Dietetics Association.
    (x) To be designated as a human services professional an individual 
must have at least a bachelor's degree in a human services field 
(including, but not limited to: sociology, special education, 
rehabilitation counseling, and psychology).
    (xi) If the client's individual program plan is being successfully 
implemented by facility staff, professional program

[[Page 141]]

staff meeting the qualifications of paragraph (b)(5) (i) through (x) of 
this section are not required--
    (A) Except for qualified intellectual disability professionals;
    (B) Except for the requirements of paragraph (b)(2) of this section 
concerning the facility's provision of enough qualified professional 
program staff; and
    (C) Unless otherwise specified by State licensure and certification 
requirements.
    (c) Standard: Facility staffing. (1) The facility must not depend 
upon clients or volunteers to perform direct care services for the 
facility.
    (2) There must be responsible direct care staff on duty and awake on 
a 24-hour basis, when clients are present, to take prompt, appropriate 
action in case of injury, illness, fire or other emergency, in each 
defined residential living unit housing--
    (i) Clients for whom a physician has ordered a medical care plan;
    (ii) Clients who are aggressive, assaultive or security risks;
    (iii) More than 16 clients; or
    (iv) Fewer than 16 clients within a multi-unit building.
    (3) There must be a responsible direct care staff person on duty on 
a 24 hour basis (when clients are present) to respond to injuries and 
symptoms of illness, and to handle emergencies, in each defined 
residential living unit housing--
    (i) Clients for whom a physician has not ordered a medical care 
plan;
    (ii) Clients who are not aggressive, assaultive or security risks; 
and
    (iii) Sixteen or fewer clients,
    (4) The facility must provide sufficient support staff so that 
direct care staff are not required to perform support services to the 
extent that these duties interfere with the exercise of their primary 
direct client care duties.
    (d) Standard: Direct care (residential living unit) staff. (1) The 
facility must provide sufficient direct care staff to manage and 
supervise clients in accordance with their individual program plans.
    (2) Direct care staff are defined as the present on-duty staff 
calculated over all shifts in a 24-hour period for each defined 
residential living unit.
    (3) Direct care staff must be provided by the facility in the 
following minimum ratios of direct care staff to clients:
    (i) For each defined residential living unit serving children under 
the age of 12, severely and profoundly retarded clients, clients with 
severe physical disabilities, or clients who are aggressive, assaultive, 
or security risks, or who manifest severely hyperactive or psychotic-
like behavior, the staff to client ratio is 1 to 3.2.
    (ii) For each defined residential living unit serving moderately 
retarded clients, the staff to client ratio is 1 to 4.
    (iii) For each defined residential living unit serving clients who 
function within the range of mild retardation, the staff to client ratio 
is 1 to 6.4.
    (4) When there are no clients present in the living unit, a 
responsible staff member must be available by telephone.
    (e) Standard: Staff training program. (1) The facility must provide 
each employee with initial and continuing training that enables the 
employee to perform his or her duties effectively, efficiently, and 
competently.
    (2) For employees who work with clients, training must focus on 
skills and competencies directed toward clients' developmental, 
behavioral, and health needs.
    (3) Staff must be able to demonstrate the skills and techniques 
necessary to administer interventions to manage the inappropriate 
behavior of clients.
    (4) Staff must be able to demonstrate the skills and techniques 
necessary to implement the individual program plans for each client for 
whom they are responsible.
    (f) Standard: COVID-19 vaccines. The facility maintains 
documentation related to staff that includes at a minimum, all of the 
following:
    (1) Staff were provided education regarding the benefits and risks 
and potential side effects associated with the COVID-19 vaccine.
    (2) Staff were offered COVID-19 vaccine or information on obtaining 
the COVID-19 vaccine.

[53 FR 20496, June 3, 1988, as amended at 86 FR 26335, May 13, 2021]

[[Page 142]]



Sec. 483.440  Condition of participation: Active treatment services.

    (a) Standard: Active treatment. (1) Each client must receive a 
continuous active treatment program, which includes aggressive, 
consistent implementation of a program of specialized and generic 
training, treatment, health services and related services described in 
this subpart, that is directed toward--
    (i) The acquisition of the behaviors necessary for the client to 
function with as much self determination and independence as possible; 
and
    (ii) The prevention or deceleration of regression or loss of current 
optimal functional status.
    (2) Active treatment does not include services to maintain generally 
independent clients who are able to function with little supervision or 
in the absence of a continuous active treatment program.
    (b) Standard: Admissions, transfers, and discharge. (1) Clients who 
are admitted by the facility must be in need of and receiving active 
treatment services.
    (2) Admission decisions must be based on a preliminary evaluation of 
the client that is conducted or updated by the facility or by outside 
sources.
    (3) A preliminary evaluation must contain background information as 
well as currently valid assessments of functional developmental, 
behavioral, social, health and nutritional status to determine if the 
facility can provide for the client's needs and if the client is likely 
to benefit from placement in the facility.
    (4) If a client is to be either transferred or discharged, the 
facility must--
    (i) Have documentation in the client's record that the client was 
transferred or discharged for good cause; and
    (ii) Provide a reasonable time to prepare the client and his or her 
parents or guardian for the transfer or discharge (except in 
emergencies).
    (5) At the time of the discharge, the facility must--
    (i) Develop a final summary of the client's developmental, 
behavioral, social, health and nutritional status and, with the consent 
of the client, parents (if the client is a minor) or legal guardian, 
provide a copy to authorized persons and agencies; and
    (ii) Provide a post-discharge plan of care that will assist the 
client to adjust to the new living environment.
    (c) Standard: Individual program plan. (1) Each client must have an 
individual program plan developed by an interdisciplinary team that 
represents the professions, disciplines or service areas that are 
relevant to--
    (i) Identifying the client's needs, as described by the 
comprehensive functional assessments required in paragraph (c)(3) of 
this section; and
    (ii) Designing programs that meet the client's needs.
    (2) Appropriate facility staff must participate in interdisciplinary 
team meetings. Participation by other agencies serving the client is 
encouraged. Participation by the client, his or her parent (if the 
client is a minor), or the client's legal guardian is required unless 
that participation is unobtainable or inappropriate.
    (3) Within 30 days after admission, the interdisciplinary team must 
perform accurate assessments or reassessments as needed to supplement 
the preliminary evaluation conducted prior to admission. The 
comprehensive functional assessment must take into consideration the 
client's age (for example, child, young adult, elderly person) and the 
implications for active treatment at each stage, as applicable, and 
must--
    (i) Identify the presenting problems and disabilities and where 
possible, their causes;
    (ii) Identify the client's specific developmental strengths;
    (iii) Identify the client's specific developmental and behavioral 
management needs;
    (iv) Identify the client's need for services without regard to the 
actual availability of the services needed; and
    (v) Include physical development and health, nutritional status, 
sensorimotor development, affective development, speech and language 
development and auditory functioning, cognitive development, social 
development, adaptive behaviors or independent living skills necessary 
for the client to be able to function in the

[[Page 143]]

community, and as applicable, vocational skills.
    (4) Within 30 days after admission, the interdisciplinary team must 
prepare for each client an individual program plan that states the 
specific objectives necessary to meet the client's needs, as identified 
by the comprehensive assessment required by paragraph (c)(3) of this 
section, and the planned sequence for dealing with those objectives. 
These objectives must--
    (i) Be stated separately, in terms of a single behavioral outcome;
    (ii) Be assigned projected completion dates;
    (iii) Be expressed in behavioral terms that provide measurable 
indices of performance;
    (iv) Be organized to reflect a developmental progression appropriate 
to the individual; and
    (v) Be assigned priorities.
    (5) Each written training program designed to implement the 
objectives in the individual program plan must specify:
    (i) The methods to be used;
    (ii) The schedule for use of the method;
    (iii) The person responsible for the program;
    (iv) The type of data and frequency of data collection necessary to 
be able to assess progress toward the desired objectives;
    (v) The inappropriate client behavior(s), if applicable; and
    (vi) Provision for the appropriate expression of behavior and the 
replacement of inappropriate behavior, if applicable, with behavior that 
is adaptive or appropriate.
    (6) The individual program plan must also:
    (i) Describe relevant interventions to support the individual toward 
independence.
    (ii) Identify the location where program strategy information (which 
must be accessible to any person responsible for implementation) can be 
found.
    (iii) Include, for those clients who lack them, training in personal 
skills essential for privacy and independence (including, but not 
limited to, toilet training, personal hygiene, dental hygiene, self-
feeding, bathing, dressing, grooming, and communication of basic needs), 
until it has been demonstrated that the client is developmentally 
incapable of acquiring them.
    (iv) Identify mechanical supports, if needed, to achieve proper body 
position, balance, or alignment. The plan must specify the reason for 
each support, the situations in which each is to be applied, and a 
schedule for the use of each support.
    (v) Provide that clients who have multiple disabling conditions 
spend a major portion of each waking day out of bed and outside the 
bedroom area, moving about by various methods and devices whenever 
possible.
    (vi) Include opportunities for client choice and self-management.
    (7) A copy of each client's individual program plan must be made 
available to all relevant staff, including staff of other agencies who 
work with the client, and to the client, parents (if the client is a 
minor) or legal guardian.
    (d) Standard: Program implementation. (1) As soon as the 
interdisciplinary team has formulated a client's individual program 
plan, each client must receive a continuous active treatment program 
consisting of needed interventions and services in sufficient number and 
frequency to support the achievement of the objectives identified in the 
individual program plan.
    (2) The facility must develop an active treatment schedule that 
outlines the current active treatment program and that is readily 
available for review by relevant staff.
    (3) Except for those facets of the individual program plan that must 
be implemented only by licensed personnel, each client's individual 
program plan must be implemented by all staff who work with the client, 
including professional, paraprofessional and nonprofessional staff.
    (e) Standard: Program documentation. (1) Data relative to 
accomplishment of the criteria specified in client individual program 
plan objectives must be documented in measureable terms.
    (2) The facility must document significant events that are related 
to the client's individual program plan and assessments and that 
contribute to an overall understanding of the client's

[[Page 144]]

ongoing level and quality of functioning.
    (f) Standard: Program monitoring and change. (1) The individual 
program plan must be reviewed at least by the qualified intellectual 
disability professional and revised as necessary, including, but not 
limited to situations in which the client--
    (i) Has successfully completed an objective or objectives identified 
in the individual program plan;
    (ii) Is regressing or losing skills already gained;
    (iii) Is failing to progress toward identified objectives after 
reasonable efforts have been made; or
    (iv) Is being considered for training towards new objectives.
    (2) At least annually, the comprehensive functional assessment of 
each client must be reviewed by the interdisciplinary team for relevancy 
and updated as needed, and the individual program plan must be revised, 
as appropriate, repeating the process set forth in paragraph (c) of this 
section.
    (3) The facility must designate and use a specially constituted 
committee or committees consisting of members of facility staff, 
parents, legal guardians, clients (as appropriate), qualified persons 
who have either experience or training in contemporary practices to 
change inappropriate client behavior, and persons with no ownership or 
controlling interest in the facility to--
    (i) Review, approve, and monitor individual programs designed to 
manage inappropriate behavior and other programs that, in the opinion of 
the committee, involve risks to client protection and rights;
    (ii) Insure that these programs are conducted only with the written 
informed consent of the client, parent (if the client is a minor), or 
legal guardian; and
    (iii) Review, monitor and make suggestions to the facility about its 
practices and programs as they relate to drug usage, physical 
restraints, time-out rooms, application of painful or noxious stimuli, 
control of inappropriate behavior, protection of client rights and 
funds, and any other area that the committee believes need to be 
addressed.
    (4) The provisions of paragraph (f)(3) of this section may be 
modified only if, in the judgment of the State survey agency, Court 
decrees, State law or regulations provide for equivalent client 
protection and consultation.



Sec. 483.450  Condition of participation: Client behavior and facility
practices.

    (a) Standard: Facility practices--Conduct toward clients. (1) The 
facility must develop and implement written policies and procedures for 
the management of conduct between staff and clients. These policies and 
procedures must--
    (i) Promote the growth, development and independence of the client;
    (ii) Address the extent to which client choice will be accommodated 
in daily decision-making, emphasizing self-determination and self-
management, to the extent possible;
    (iii) Specify client conduct to be allowed or not allowed; and
    (iv) Be available to all staff, clients, parents of minor children, 
and legal guardians.
    (2) To the extent possible, clients must participate in the 
formulation of these policies and procedures.
    (3) Clients must not discipline other clients, except as part of an 
organized system of self-government, as set forth in facility policy.
    (b) Standard: Management of inappropriate client behavior. (1) The 
facility must develop and implement written policies and procedures that 
govern the management of inappropriate client behavior. These policies 
and procedures must be consistent with the provisions of paragraph (a) 
of this section. These procedures must--
    (i) Specify all facility approved interventions to manage 
inappropriate client behavior;
    (ii) Designate these interventions on a hierarchy to be implemented, 
ranging from most positive or least intrusive, to least positive or most 
intrusive;
    (iii) Insure, prior to the use of more restrictive techniques, that 
the client's record documents that programs incorporating the use of 
less intrusive or more positive techniques have been tried 
systematically and demonstrated to be ineffective; and

[[Page 145]]

    (iv) Address the following:
    (A) The use of time-out rooms.
    (B) The use of physical restraints.
    (C) The use of drugs to manage inappropriate behavior.
    (D) The application of painful or noxious stimuli.
    (E) The staff members who may authorize the use of specified 
interventions.
    (F) A mechanism for monitoring and controlling the use of such 
interventions.
    (2) Interventions to manage inappropriate client behavior must be 
employed with sufficient safeguards and supervision to ensure that the 
safety, welfare and civil and human rights of clients are adequately 
protected.
    (3) Techniques to manage inappropriate client behavior must never be 
used for disciplinary purposes, for the convenience of staff or as a 
substitute for an active treatment program.
    (4) The use of systematic interventions to manage inappropriate 
client behavior must be incorporated into the client's individual 
program plan, in accordance with Sec. 483.440(c) (4) and (5) of this 
subpart.
    (5) Standing or as needed programs to control inappropriate behavior 
are not permitted.
    (c) Standard: Time-out rooms. (1) A client may be placed in a room 
from which egress is prevented only if the following conditions are met:
    (i) The placement is a part of an approved systematic time-out 
program as required by paragraph (b) of this section. (Thus, emergency 
placement of a client into a time-out room is not allowed.)
    (ii) The client is under the direct constant visual supervision of 
designated staff.
    (iii) The door to the room is held shut by staff or by a mechanism 
requiring constant physical pressure from a staff member to keep the 
mechanism engaged.
    (2) Placement of a client in a time-out room must not exceed one 
hour.
    (3) Clients placed in time-out rooms must be protected from 
hazardous conditions including, but not limited to, presence of sharp 
corners and objects, uncovered light fixtures, unprotected electrical 
outlets.
    (4) A record of time-out activities must be kept.
    (d) Standard: Physical restraints. (1) The facility may employ 
physical restraint only--
    (i) As an integral part of an individual program plan that is 
intended to lead to less restrictive means of managing and eliminating 
the behavior for which the restraint is applied;
    (ii) As an emergency measure, but only if absolutely necessary to 
protect the client or others from injury; or
    (iii) As a health-related protection prescribed by a physician, but 
only if absolutely necessary during the conduct of a specific medical or 
surgical procedure, or only if absolutely necessary for client 
protection during the time that a medical condition exists.
    (2) Authorizations to use or extend restraints as an emergency must 
be:
    (i) In effect no longer than 12 consecutive hours; and
    (ii) Obtained as soon as the client is restrained or stable.
    (3) The facility must not issue orders for restraint on a standing 
or as needed basis.
    (4) A client placed in restraint must be checked at least every 30 
minutes by staff trained in the use of restraints, released from the 
restraint as quickly as possible, and a record of these checks and usage 
must be kept.
    (5) Restraints must be designed and used so as not to cause physical 
injury to the client and so as to cause the least possible discomfort.
    (6) Opportunity for motion and exercise must be provided for a 
period of not less than 10 minutes during each two hour period in which 
restraint is employed, and a record of such activity must be kept.
    (7) Barred enclosures must not be more than three feet in height and 
must not have tops.
    (e) Standard: Drug usage. (1) The facility must not use drugs in 
doses that interfere with the individual client's daily living 
activities.
    (2) Drugs used for control of inappropriate behavior must be 
approved by the interdisciplinary team and be used only as an integral 
part of the client's individual program plan that is directed 
specifically towards the reduction of and eventual elimination of the

[[Page 146]]

behaviors for which the drugs are employed.
    (3) Drugs used for control of inappropriate behavior must not be 
used until it can be justified that the harmful effects of the behavior 
clearly outweigh the potentially harmful effects of the drugs.
    (4) Drugs used for control of inappropriate behavior must be--
    (i) Monitored closely, in conjunction with the physician and the 
drug regimen review requirement at Sec. 483.460(j), for desired 
responses and adverse consequences by facility staff; and
    (ii) Gradually withdrawn at least annually in a carefully monitored 
program conducted in conjunction with the interdisciplinary team, unless 
clinical evidence justifies that this is contraindicated.



Sec. 483.460  Condition of participation: Health care services.

    (a) Standard: Physician services. (1) The facility must ensure the 
availability of physician services 24 hours a day.
    (2) The physician must develop, in coordination with licensed 
nursing personnel, a medical care plan of treatment for a client if the 
physician determines that an individual client requires 24-hour licensed 
nursing care. This plan must be integrated in the individual program 
plan.
    (3) The facility must provide or obtain preventive and general 
medical care as well as annual physical examinations of each client that 
at a minimum include the following:
    (i) Evaluation of vision and hearing.
    (ii) Immunizations, using as a guide the recommendations of the 
Public Health Service Advisory Committee on Immunization Practices or of 
the Committee on the Control of Infectious Diseases of the American 
Academy of Pediatrics.
    (iii) Routine screening laboratory examinations as determined 
necessary by the physician, and special studies when needed.
    (iv) Tuberculosis control, appropriate to the facility's population, 
and in accordance with the recommendations of the American College of 
Chest Physicians or the section of diseases of the chest of the American 
Academy of Pediatrics, or both.
    (4) The intermediate care facility for individuals with intellectual 
disabilities (ICF/IID) must develop and implement policies and 
procedures to ensure all of the following:
    (i) When COVID-19 vaccine is available to the facility, each client 
and staff member is offered the COVID-19 vaccine unless the immunization 
is medically contraindicated or the client or staff member has already 
been immunized.
    (ii) Before offering COVID-19 vaccine, all staff members are 
provided with education regarding the benefits and risks and potential 
side effects associated with the vaccine.
    (iii) Before offering COVID-19 vaccine, each client or the client's 
representative receives education regarding the benefits and risks and 
potential side effects associated with the COVID-19 vaccine.
    (iv) In situations where COVID-19 vaccination requires multiple 
doses, the client, client's representative, or staff member is provided 
with current information regarding each additional dose, including any 
changes in the benefits or risks and potential side effects associated 
with the COVID-19 vaccine, before requesting consent for administration 
of each additional doses.
    (v) The client, client's representative, or staff member has the 
opportunity to accept or refuse COVID-19 vaccine, and change their 
decision.
    (vi) The client's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the client or client's representative was provided 
education regarding the benefits and risks and potential side effects of 
COVID-19 vaccine; and
    (B) Each dose of COVID-19 vaccine administered to the client; or
    (C) If the client did not receive the COVID-19 vaccine due to 
medical contraindications or refusal.
    (5) To the extent permitted by State law, the facility may utilize 
physician assistants and nurse practitioners to provide physician 
services as described in this section.

[[Page 147]]

    (b) Standard: Physician participation in the individual program 
plan. A physician must participate in--
    (1) The establishment of each newly admitted client's initial 
individual program plan as required by Sec. 456.380 of this chapter 
that specified plan of care requirements for ICFs; and
    (2) If appropriate, physicians must participate in the review and 
update of an individual program plan as part of the interdisciplinary 
team process either in person or through written report to the 
interdisciplinary team.
    (c) Standard: Nursing services. The facility must provide clients 
with nursing services in accordance with their needs. These services 
must include--
    (1) Participation as appropriate in the development, review, and 
update of an individual program plan as part of the interdisciplinary 
team process;
    (2) The development, with a physician, of a medical care plan of 
treatment for a client when the physician has determined that an 
individual client requires such a plan;
    (3) For those clients certified as not needing a medical care plan, 
a review of their health status which must--
    (i) Be by a direct physical examination;
    (ii) Be by a licensed nurse;
    (iii) Be on a quarterly or more frequent basis depending on client 
need;
    (iv) Be recorded in the client's record; and
    (v) Result in any necessary action (including referral to a 
physician to address client health problems).
    (4) Other nursing care as prescribed by the physician or as 
identified by client needs; and
    (5) Implementing, with other members of the interdisciplinary team, 
appropriate protective and preventive health measures that include, but 
are not limited to--
    (i) Training clients and staff as needed in appropriate health and 
hygiene methods;
    (ii) Control of communicable diseases and infections, including the 
instruction of other personnel in methods of infection control; and
    (iii) Training direct care staff in detecting signs and symptoms of 
illness or dysfunction, first aid for accidents or illness, and basic 
skills required to meet the health needs of the clients.
    (d) Standard: Nursing staff. (1) Nurses providing services in the 
facility must have a current license to practice in the State.
    (2) The facility must employ or arrange for licensed nursing 
services sufficient to care for clients health needs including those 
clients with medical care plans.
    (3) The facility must utilize registered nurses as appropriate and 
required by State law to perform the health services specified in this 
section.
    (4) If the facility utilizes only licensed practical or vocational 
nurses to provide health services, it must have a formal arrangement 
with a registered nurse to be available for verbal or onsite 
consultation to the licensed practical or vocational nurse.
    (5) Non-licensed nursing personnel who work with clients under a 
medical care plan must do so under the supervision of licensed persons.
    (e) Standard: Dental services. (1) The facility must provide or make 
arrangements for comprehensive diagnostic and treatment services for 
each client from qualified personnel, including licensed dentists and 
dental hygienists either through organized dental services in-house or 
through arrangement.
    (2) If appropriate, dental professionals must participate, in the 
development, review and update of an individual program plan as part of 
the interdisciplinary process either in person or through written report 
to the interdisciplinary team.
    (3) The facility must provide education and training in the 
maintenance of oral health.
    (f) Standard: Comprehensive dental diagnostic services. 
Comprehensive dental diagnostic services include--
    (1) A complete extraoral and intraoral examination, using all 
diagnostic aids necessary to properly evaluate the client's oral 
condition, not later than one month after admission to the facility 
(unless the examination was completed within twelve months before 
admission);
    (2) Periodic examination and diagnosis performed at least annually, 
including radiographs when indicated

[[Page 148]]

and detection of manifestations of systemic disease; and
    (3) A review of the results of examination and entry of the results 
in the client's dental record.
    (g) Standard: Comprehensive dental treatment. The facility must 
ensure comprehensive dental treatment services that include--
    (1) The availability for emergency dental treatment on a 24-hour-a-
day basis by a licensed dentist; and
    (2) Dental care needed for relief of pain and infections, 
restoration of teeth, and maintenance of dental health.
    (h) Standard: Documentation of dental services. (1) If the facility 
maintains an in-house dental service, the facility must keep a permanent 
dental record for each client, with a dental summary maintained in the 
client's living unit.
    (2) If the facility does not maintain an in-house dental service, 
the facility must obtain a dental summary of the results of dental 
visits and maintain the summary in the client's living unit.
    (i) Standard: Pharmacy services. The facility must provide or make 
arrangements for the provision of routine and emergency drugs and 
biologicals to its clients. Drugs and biologicals may be obtained from 
community or contract pharmacists or the facility may maintain a 
licensed pharmacy.
    (j) Standard: Drug regimen review. (1) A pharmacist with input from 
the interdisciplinary team must review the drug regimen of each client 
at least quarterly.
    (2) The pharmacist must report any irregularities in clients' drug 
regimens to the prescribing physician and interdisciplinary team.
    (3) The pharmacist must prepare a record of each client's drug 
regimen reviews and the facility must maintain that record.
    (4) An individual medication administration record must be 
maintained for each client.
    (5) As appropriate the pharmacist must participate in the 
development, implementation, and review of each client's individual 
program plan either in person or through written report to the 
interdisciplinary team.
    (k) Standard: Drug administration. The facility must have an 
organized system for drug administration that identifies each drug up to 
the point of administration. The system must assure that--
    (1) All drugs are administered in compliance with the physician's 
orders;
    (2) All drugs, including those that are self-administered, are 
administered without error;
    (3) Unlicensed personnel are allowed to administer drugs only if 
State law permits;
    (4) Clients are taught how to administer their own medications if 
the interdisciplinary team determines that self administration of 
medications is an appropriate objective, and if the physician does not 
specify otherwise;
    (5) The client's physician is informed of the interdisciplinary 
team's decision that self-administration of medications is an objective 
for the client;
    (6) No client self-administers medications until he or she 
demonstrates the competency to do so;
    (7) Drugs used by clients while not under the direct care of the 
facility are packaged and labeled in accordance with State law; and
    (8) Drug administration errors and adverse drug reactions are 
recorded and reported immediately to a physician.
    (l) Standard: Drug storage and recordkeeping. (1) The facility must 
store drugs under proper conditions of sanitation, temperature, light, 
humidity, and security.
    (2) The facility must keep all drugs and biologicals locked except 
when being prepared for administration. Only authorized persons may have 
access to the keys to the drug storage area. Clients who have been 
trained to self administer drugs in accordance with Sec. 483.460(k)(4) 
may have access to keys to their individual drug supply.
    (3) The facility must maintain records of the receipt and 
disposition of all controlled drugs.
    (4) The facility must, on a sample basis, periodically reconcile the 
receipt and disposition of all controlled drugs in schedules II through 
IV (drugs subject to the Comprehensive Drug Abuse Prevention and Control 
Act of 1970, 21 U.S.C. 801 et seq., as implemented by 21 CFR part 308).

[[Page 149]]

    (5) If the facility maintains a licensed pharmacy, the facility must 
comply with the regulations for controlled drugs.
    (m) Standard: Drug labeling. (1) Labeling of drugs and biologicals 
must--
    (i) Be based on currently accepted professional principles and 
practices; and
    (ii) Include the appropriate accessory and cautionary instructions, 
as well as the expiration date, if applicable.
    (2) The facility must remove from use--
    (i) Outdated drugs; and
    (ii) Drug containers with worn, illegible, or missing labels.
    (3) Drugs and biologicals packaged in containers designated for a 
particular client must be immediately removed from the client's current 
medication supply if discontinued by the physician.
    (n) Standard: Laboratory services. (1) If a facility chooses to 
provide laboratory services, the laboratory must meet the requirements 
specified in part 493 of this chapter.
    (2) If the laboratory chooses to refer specimens for testing to 
another laboratory, the referral laboratory must be certified in the 
appropriate specialties and subspecialities of service in accordance 
with the requirements of part 493 of this chapter.

[53 FR 20496, June 3, 1988, as amended at 57 FR 7136, Feb. 28, 1992; 86 
FR 26336, May 13, 2021]



Sec. 483.470  Condition of participation: Physical environment.

    (a) Standard: Client living environment. (1) The facility must not 
house clients of grossly different ages, developmental levels, and 
social needs in close physical or social proximity unless the housing is 
planned to promote the growth and development of all those housed 
together.
    (2) The facility must not segregate clients solely on the basis of 
their physical disabilities. It must integrate clients who have 
ambulation deficits or who are deaf, blind, or have seizure disorders, 
etc., with others of comparable social and intellectual development.
    (b) Standard: Client bedrooms. (1) Bedrooms must--
    (i) Be rooms that have at least one outside wall;
    (ii) Be equipped with or located near toilet and bathing facilities;
    (iii) Accommodate no more than four clients unless granted a 
variance under paragraph (b)(3) of this section;
    (iv) Measure at least 60 square feet per client in multiple client 
bedrooms and at least 80 square feet in single client bedrooms; and
    (v) In all facilities initially certified, or in buildings 
constructed or with major renovations or conversions on or after October 
3, 1988, have walls that extend from floor to ceiling.
    (2) If a bedroom is below grade level, it must have a window that--
    (i) Is usable as a second means of escape by the client(s) occupying 
the room; and
    (ii) Is no more than 44 inches (measured to the window sill) above 
the floor unless the facility is surveyed under the Health Care 
Occupancy Chapter of the Life Safety Code, in which case the window must 
be no more than 36 inches (measured to the window sill) above the floor.
    (3) The survey agency may grant a variance from the limit of four 
clients per room only if a physician who is a member of the 
interdisciplinary team and who is a qualified intellectual disability 
professional--
    (i) Certifies that each client to be placed in a bedroom housing 
more than four persons is so severely medically impaired as to require 
direct and continuous monitoring during sleeping hours; and
    (ii) Documents the reasons why housing in a room of only four or 
fewer persons would not be medically feasible.
    (4) The facility must provide each client with--
    (i) A separate bed of proper size and height for the convenience of 
the client;
    (ii) A clean, comfortable, mattress;
    (iii) Bedding appropriate to the weather and climate; and
    (iv) Functional furniture appropriate to the client's needs, and 
individual closet space in the client's bedroom with clothes racks and 
shelves accessible to the client.
    (c) Standard: Storage space in bedroom. The facility must provide--

[[Page 150]]

    (1) Space and equipment for daily out-of-bed activity for all 
clients who are not yet mobile, except those who have a short-term 
illness or those few clients for whom out-of-bed activity is a threat to 
health and safety; and
    (2) Suitable storage space, accessible to clients, for personal 
possessions, such as TVs, radios, prosthetic equipment and clothing.
    (d) Standard: Client bathrooms. The facility must--
    (1) Provide toilet and bathing facilities appropriate in number, 
size, and design to meet the needs of the clients;
    (2) Provide for individual privacy in toilets, bathtubs, and 
showers; and
    (3) In areas of the facility where clients who have not been trained 
to regulate water temperature are exposed to hot water, ensure that the 
temperature of the water does not exceed 110 [deg]Fahrenheit.
    (e) Standard: Heating and ventilation. (1) Each client bedroom in 
the facility must have--
    (i) At least one window to the outside; and
    (ii) Direct outside ventilation by means of windows, air 
conditioning, or mechanical ventilation.
    (2) The facility must--
    (i) Maintain the temperature and humidity within a normal comfort 
range by heating, air conditioning or other means; and
    (ii) Ensure that the heating apparatus does not constitute a burn or 
smoke hazard to clients.
    (f) Standard: Floors. The facility must have--
    (1) Floors that have a resilient, nonabrasive, and slip-resistant 
surface;
    (2) Nonabrasive carpeting, if the area used by clients is carpeted 
and serves clients who lie on the floor or ambulate with parts of their 
bodies, other than feet, touching the floor; and
    (3) Exposed floor surfaces and floor coverings that promote mobility 
in areas used by clients, and promote maintenance of sanitary 
conditions.
    (g) Standard: Space and equipment. The facility must--
    (1) Provide sufficient space and equipment in dining, living, health 
services, recreation, and program areas (including adequately equipped 
and sound treated areas for hearing and other evaluations if they are 
conducted in the facility) to enable staff to provide clients with 
needed services as required by this subpart and as identified in each 
client's individual program plan.
    (2) Furnish, maintain in good repair, and teach clients to use and 
to make informed choices about the use of dentures, eyeglasses, hearing 
and other communications aids, braces, and other devices identified by 
the interdisciplinary team as needed by the client.
    (3) Provide adequate clean linen and dirty linen storage areas.
    (h) [Reserved]
    (i) Standard: Evacuation drills. (1) The facility must hold 
evacuation drills at least quarterly for each shift of personnel and 
under varied conditions to--
    (i) Ensure that all personnel on all shifts are trained to perform 
assigned tasks;
    (ii) Ensure that all personnel on all shifts are familiar with the 
use of the facility's fire protection features; and
    (iii) Evaluate the effectiveness of emergency and disaster plans and 
procedures.
    (2) The facility must--
    (i) Actually evacuate clients during at least one drill each year on 
each shift;
    (ii) Make special provisions for the evacuation of clients with 
physical disabilities;
    (iii) File a report and evaluation on each evacuation drill;
    (iv) Investigate all problems with evacuation drills, including 
accidents, and take corrective action; and
    (v) During fire drills, clients may be evacuated to a safe area in 
facilities certified under the Health Care Occupancies Chapter of the 
Life Safety Code.
    (3) Facilities must meet the requirements of paragraphs (i)(1) and 
(2) of this section for any live-in and relief staff they utilize.
    (j) Standard: Fire protection--(1) General. Except as otherwise 
provided in this section--
    (i) The facility must meet the applicable provisions of either the 
Health Care Occupancies Chapters or the Residential Board and Care 
Occupancies Chapter and must proceed in accordance with the Life Safety 
Code (NFPA

[[Page 151]]

101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and 
TIA 12-4.)
    (ii) Notwithstanding paragraph (j)(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.
    (iii) Chapters 32.3.2.11.2 and 33.3.2.11.2 of the adopted 2012 Life 
Safety Code do not apply to a facility.
    (iv) Beginning July 5, 2019, an ICF-IID must be in compliance with 
Chapter 33.2.3.5.7.1, Sprinklers in attics, or Chapter 33.2.3.5.7.2, 
Heat detection systems in attics of the Life Safety Code.
    (2) The State survey agency may apply a single chapter of the LSC to 
the entire facility or may apply different chapters to different 
buildings or parts of buildings as permitted by the LSC.
    (3) A facility that meets the LSC definition of a residential board 
and care occupancy must have its evacuation capability evaluated in 
accordance with the Evacuation Difficulty Index of the Fire Safety 
Evaluation System for Board and Care facilities (FSES/BC).
    (4) If CMS finds that the State has a fire and safety code imposed 
by State law that adequately protects a facility's clients, CMS may 
allow the State survey agency to apply the State's fire and safety code 
instead of the LSC.
    (5) Facilities that meet the Life Safety Code definition of a health 
care occupancy. (i) 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 residential board and care facility, but only if the 
waiver will not adversely affect the health and safety of the patients.
    (ii) A facility may install alcohol-based hand rub dispensers if the 
dispensers are installed in a manner that adequately protects against 
inappropriate access.
    (iii) When a sprinkler system is shut down for more than 10 hours, 
the ICF-IID must:
    (A) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (B) Establish a fire watch until the system is back in service.
    (iv) Beginning July 5, 2019, an ICF-IID must be in compliance with 
Chapter 33.2.3.5.7.1, sprinklers in attics, or Chapter 33.2.3.5.7.2, 
heat detection systems in attics of the Life Safety Code.
    (v) Except as otherwise provided in this section, ICF-IIDs 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).
    (A) Chapter 7,8,12 and 13 of the adopted Health Care Facilities Code 
does not apply to an ICF-IID.
    (B) If application of the Health Care Facilities Code required under 
paragraph (j)(5)(iv) of this section would result in unreasonable 
hardship for the ICF-IID, 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 clients.
    (k) Standard: Paint. The facility must--
    (1) Use lead-free paint inside the facility; and
    (2) Remove or cover interior paint or plaster containing lead so 
that it is not accessible to clients.
    (l) Standard: Infection control. (1) The facility must provide a 
sanitary environment to avoid sources and transmission of infections. 
There must be an active program for the prevention, control, and 
investigation of infection and communicable diseases.
    (2) The facility must implement successful corrective action in 
affected problem areas.
    (3) The facility must maintain a record of incidents and corrective 
actions related to infections.
    (4) The facility must prohibit employees with symptoms or signs of a 
communicable disease from direct contact with clients and their food.
    (m) 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.

[[Page 152]]

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]

[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991, 
as amended at 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 
FR 15239, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26900, May 
4, 2016; 81 FR 64032, Sept. 16, 2016]



Sec. 483.475  Condition of participation: Emergency preparedness.

    The Intermediate Care Facility for Individuals with Intellectual 
Disabilities (ICF/IID) must comply with all applicable Federal, State, 
and local emergency preparedness requirements. The ICF/IID 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 ICF/IID must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach, 
including missing clients.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address the special needs of its client population, including, 
but not limited to, persons at-risk; the type of services the ICF/IID 
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 ICF/IID 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 clients, 
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 client 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.

[[Page 153]]

    (2) A system to track the location of on-duty staff and sheltered 
clients in the ICF/IID's care during and after an emergency. If on-duty 
staff and sheltered clients are relocated during the emergency, the ICF/
IID must document the specific name and location of the receiving 
facility or other location.
    (3) Safe evacuation from the ICF/IID, 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 clients, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves client 
information, protects confidentiality of client 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 role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (7) The development of arrangements with other ICF/IIDs or other 
providers to receive clients in the event of limitations or cessation of 
operations to maintain the continuity of services to ICF/IID clients.
    (8) The role of the ICF/IID 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.
    (c) Communication plan. The ICF/IID 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 the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Clients' physicians.
    (iv) Other ICF/IIDs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (iii) The State Licensing and Certification Agency.
    (iv) The State Protection and Advocacy Agency.
    (3) Primary and alternate means for communicating with the ICF/IID's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
clients under the ICF/IID'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 client 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of clients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the ICF/IID's occupancy, 
needs, and its ability to provide assistance, to the authority having 
jurisdiction, the Incident Command Center, or designee.
    (8) A method for sharing information from the emergency plan that 
the facility has determined is appropriate with clients and their 
families or representatives.
    (d) Training and testing. The ICF/IID 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. The ICF/IID must meet the 
requirements for evacuation drills and training at Sec. 483.470(i).
    (1) Training program. The ICF/IID must do all the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and

[[Page 154]]

volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the ICF/IID must conduct training on the updated 
policies and procedures.
    (2) Testing. The ICF/IID must conduct exercises to test the 
emergency plan at least twice per year. The ICF/IID 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 ICF/IID experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the ICF/IID 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 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 ICF/IID's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
ICF/IID's emergency plan, as needed.
    (e) Integrated healthcare systems. If an ICF/IID 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 ICF/IID may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of 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 
all of 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 64032, Sept. 16, 2016, as amended at 84 FR 51824, Sept. 30, 2019]



Sec. 483.480  Condition of participation: Dietetic services.

    (a) Standard: Food and nutrition services. (1) Each client must 
receive a nourishing, well-balanced diet including modified and 
specially-prescribed diets.
    (2) A qualified dietitian must be employed either full-time, part-
time, or on a consultant basis at the facility's discretion.

[[Page 155]]

    (3) If a qualified dietitian is not employed full-time, the facility 
must designate a person to serve as the director of food services.
    (4) The client's interdisciplinary team, including a qualified 
dietitian and physician, must prescribe all modified and special diets 
including those used as a part of a program to manage inappropriate 
client behavior.
    (5) Foods proposed for use as a primary reinforcement of adaptive 
behavior are evaluated in light of the client's nutritional status and 
needs.
    (6) Unless otherwise specified by medical needs, the diet must be 
prepared at least in accordance with the latest edition of the 
recommended dietary allowances of the Food and Nutrition Board of the 
National Research Council, National Academy of Sciences, adjusted for 
age, sex, disability and activity.
    (b) Standard: Meal services. (1) Each client must receive at least 
three meals daily, at regular times comparable to normal mealtimes in 
the community with--
    (i) Not more than 14 hours between a substantial evening meal and 
breakfast of the following day, except on weekends and holidays when a 
nourishing snack is provided at bedtime, 16 hours may elapse between a 
substantial evening meal and breakfast; and
    (ii) Not less than 10 hours between breakfast and the evening meal 
of the same day, except as provided under paragraph (b)(1)(i) of this 
section.
    (2) Food must be served--
    (i) In appropriate quantity;
    (ii) At appropriate temperature;
    (iii) In a form consistent with the developmental level of the 
client; and
    (iv) With appropriate utensils.
    (3) Food served to clients individually and uneaten must be 
discarded.
    (c) Standard: Menus. (1) Menus must--
    (i) Be prepared in advance;
    (ii) Provide a variety of foods at each meal;
    (iii) Be different for the same days of each week and adjusted for 
seasonal changes; and
    (iv) Include the average portion sizes for menu items.
    (2) Menus for food actually served must be kept on file for 30 days.
    (d) Standard: Dining areas and service. The facility must--
    (1) Serve meals for all clients, including persons with ambulation 
deficits, in dining areas, unless otherwise specified by the 
interdisciplinary team or a physician;
    (2) Provide table service for all clients who can and will eat at a 
table, including clients in wheelchairs;
    (3) Equip areas with tables, chairs, eating utensils, and dishes 
designed to meet the developmental needs of each client;
    (4) Supervise and staff dining rooms adequately to direct self-help 
dining procedure, to assure that each client receives enough food and to 
assure that each client eats in a manner consistent with his or her 
developmental level: and
    (5) Ensure that each client eats in an upright position, unless 
otherwise specified by the interdisciplinary team or a physician.



PART 484_HOME HEALTH SERVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
484.1 Basis and scope.
484.2 Definitions.

                         Subpart B_Patient Care

484.40 Condition of participation: Release of patient identifiable OASIS 
          information.
484.45 Condition of participation: Reporting OASIS information.
484.50 Condition of participation: Patient rights.
484.55 Condition of participation: Comprehensive assessment of patients.
484.58 Condition of participation: Discharge planning.
484.60 Condition of participation: Care planning, coordination of 
          services, and quality of care.
484.65 Condition of participation: Quality assessment and performance 
          improvement (QAPI).
484.70 Condition of participation: Infection prevention and control.
484.75 Condition of participation: Skilled professional services.
484.80 Condition of participation: Home health aide services.

                  Subpart C_Organizational Environment

484.100 Condition of participation: Compliance with Federal, State, and 
          local laws and regulations related to health and safety of 
          patients.

[[Page 156]]

484.102 Condition of participation: Emergency preparedness.
484.105 Condition of participation: Organization and administration of 
          services.
484.110 Condition of participation: Clinical records.
484.115 Condition of participation: Personnel qualifications.

Subpart D [Reserved]

      Subpart E_Prospective Payment System for Home Health Agencies

484.200 Basis and scope.
484.202 Definitions.
484.205 Basis of payment.
484.215 Initial establishment of the calculation of the national, 
          standardized prospective payment rates.
484.220 Calculation of the case-mix and wage area adjusted prospective 
          payment rates.
484.225 Annual update of the unadjusted national, standardized 
          prospective payment rates.
484.230 Low-utilization payment adjustments.
484.235 Partial payment adjustments.
484.240 Outlier payments.
484.245 Requirements under the Home Health Quality Reporting Program (HH 
          QRP).
484.250 OASIS data.
484.260 Limitation on review.
484.265 Additional payment.

 Subpart F_Home Health Value-Based Purchasing (HHVBP) Model Components 
       for Competing Home Health Agencies Within State Boundaries

484.300 Basis and scope of subpart.
484.305 Definitions.
484.310 Applicability of the Home Health Value-Based Purchasing (HHVBP) 
          Model.
484.315 Data reporting for measures and evaluation and the public 
          reporting of model data under the Home Health Value-Based 
          Purchasing (HHVBP) Model.
484.320 Calculation of the Total Performance Score.
484.325 Payments for home health services under Home Health Value-Based 
          Purchasing (HHVBP) Model.
484.330 Process for determining and applying the value-based payment 
          adjustment under the Home Health Value-Based Purchasing 
          (HHVBP) Model.
484.335 Appeals process for the Home Health Value-Based Purchasing 
          (HHVBP) Model.

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

    Source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted.



                      Subpart A_General Provisions

    Source: 82 FR 4578, Jan. 13, 2017, unless otherwise noted.



Sec. 484.1  Basis and scope.

    (a) Basis. This part is based on:
    (1) Sections 1861(o) and 1891 of the Act, which establish the 
conditions that an HHA must meet in order to participate in the Medicare 
program and which, along with the additional requirements set forth in 
this part, are considered necessary to ensure the health and safety of 
patients; and
    (2) Section 1861(z) of the Act, which specifies the institutional 
planning standards that HHAs must meet.
    (b) Scope. The provisions of this part serve as the basis for survey 
activities for the purpose of determining whether an agency meets the 
requirements for participation in the Medicare program.



Sec. 484.2  Definitions.

    As used in subparts A, B, and C, of this part--
    Allowed practitioner means a physician assistant, nurse 
practitioner, or clinical nurse specialist as defined at this part.
    Branch office means an approved location or site from which a home 
health agency provides services within a portion of the total geographic 
area served by the parent agency. The parent home health agency must 
provide supervision and administrative control of any branch office. It 
is unnecessary for the branch office to independently meet the 
conditions of participation as a home health agency.
    Clinical note means a notation of a contact with a patient that is 
written, timed, and dated, and which describes signs and symptoms, 
treatment, drugs administered and the patient's reaction or response, 
and any changes in physical or emotional condition during a given period 
of time.
    Clinical nurse specialist means an individual as defined at Sec. 
410.76(a) and (b) of this chapter, and who is working in collaboration 
with the physician as defined at Sec. 410.76(c)(3) of this chapter.
    In advance means that HHA staff must complete the task prior to 
performing any hands-on care or any patient education.

[[Page 157]]

    Nurse practitioner means an individual as defined at Sec. 410.75(a) 
and (b) of this chapter, and who is working in collaboration with the 
physician as defined at Sec. 410.75(c)(3) of this chapter.
    Parent home health agency means the agency that provides direct 
support and administrative control of a branch.
    Physician is a doctor of medicine, osteopathy, or podiatric 
medicine, and who is not precluded from performing this function under 
paragraph (d) of this section. (A doctor of podiatric medicine may 
perform only plan of treatment functions that are consistent with the 
functions he or she is authorized to perform under State law.)
    Physician assistant means an individual as defined at Sec. 
410.74(a) and (c) of this chapter.
    Primary home health agency means the HHA which accepts the initial 
referral of a patient, and which provides services directly to the 
patient or via another health care provider under arrangements (as 
applicable).
    Proprietary agency means a private, for-profit agency.
    Pseudo-patient means a person trained to participate in a role-play 
situation, or a computer-based mannequin device. A pseudo-patient must 
be capable of responding to and interacting with the home health aide 
trainee, and must demonstrate the general characteristics of the primary 
patient population served by the HHA in key areas such as age, frailty, 
functional status, and cognitive status.
    Public agency means an agency operated by a state or local 
government.
    Quality indicator means a specific, valid, and reliable measure of 
access, care outcomes, or satisfaction, or a measure of a process of 
care.
    Representative means the patient's legal representative, such as a 
guardian, who makes health-care decisions on the patient's behalf, or a 
patient-selected representative who participates in making decisions 
related to the patient's care or well-being, including but not limited 
to, a family member or an advocate for the patient. The patient 
determines the role of the representative, to the extent possible.
    Simulation means a training and assessment technique that mimics the 
reality of the homecare environment, including environmental 
distractions and constraints that evoke or replicate substantial aspects 
of the real world in a fully interactive fashion, in order to teach and 
assess proficiency in performing skills, and to promote decision making 
and critical thinking.
    Subdivision means a component of a multi-function health agency, 
such as the home care department of a hospital or the nursing division 
of a health department, which independently meets the conditions of 
participation for HHAs. A subdivision that has branch offices is 
considered a parent agency.
    Summary report means the compilation of the pertinent factors of a 
patient's clinical notes that is submitted to the patient's physician, 
physician assistant, nurse practitioner, or clinical nurse specialist.
    Supervised practical training means training in a practicum 
laboratory or other setting in which the trainee demonstrates knowledge 
while providing covered services to an individual under the direct 
supervision of either a registered nurse or a licensed practical nurse 
who is under the supervision of a registered nurse.
    Verbal order means a physician, physician assistant, nurse 
practitioner, or clinical nurse specialist order that is spoken to 
appropriate personnel and later put in writing for the purposes of 
documenting as well as establishing or revising the patient's plan of 
care.

[82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 
85 FR 27627, May 8, 2020]



                         Subpart B_Patient Care

    Source: 82 FR 4578, Jan. 13, 2017, unless otherwise noted.



Sec. 484.40  Condition of participation: Release of patient 
identifiable OASIS information.

    The HHA and agent acting on behalf of the HHA in accordance with a 
written contract must ensure the confidentiality of all patient 
identifiable information contained in the clinical record, including 
OASIS data, and may not release patient identifiable OASIS information 
to the public.

[[Page 158]]



Sec. 484.45  Condition of participation: Reporting OASIS information.

    HHAs must electronically report all OASIS data collected in 
accordance with Sec. 484.55.
    (a) Standard: Encoding and transmitting OASIS data. An HHA must 
encode and electronically transmit each completed OASIS assessment to 
the CMS system, regarding each beneficiary with respect to which 
information is required to be transmitted (as determined by the 
Secretary), within 30 days of completing the assessment of the 
beneficiary.
    (b) Standard: Accuracy of encoded OASIS data. The encoded OASIS data 
must accurately reflect the patient's status at the time of assessment.
    (c) Standard: Transmittal of OASIS data. An HHA must--
    (1) For all completed assessments, transmit OASIS data in a format 
that meets the requirements of paragraph (d) of this section.
    (2) Transmit data using electronic communications software that 
complies with the Federal Information Processing Standard (FIPS 140-2, 
issued May 25, 2001) from the HHA or the HHA contractor to the CMS 
collection site.
    (3) Transmit data that includes the CMS-assigned branch 
identification number, as applicable.
    (d) Standard: Data Format. The HHA must encode and transmit data 
using the software available from CMS or software that conforms to CMS 
standard electronic record layout, edit specifications, and data 
dictionary, and that includes the required OASIS data set.

[82 FR 4578, Jan. 13, 2017, as amended at 85 FR 70356, Nov. 4, 2020]



Sec. 484.50  Condition of participation: Patient rights.

    The patient and representative (if any), have the right to be 
informed of the patient's rights in a language and manner the individual 
understands. The HHA must protect and promote the exercise of these 
rights.
    (a) Standard: Notice of rights. The HHA must--
    (1) Provide the patient and the patient's legal representative (if 
any), the following information during the initial evaluation visit, in 
advance of furnishing care to the patient:
    (i) Written notice of the patient's rights and responsibilities 
under this rule, and the HHA's transfer and discharge policies as set 
forth in paragraph (d) of this section. Written notice must be 
understandable to persons who have limited English proficiency and 
accessible to individuals with disabilities;
    (ii) Contact information for the HHA administrator, including the 
administrator's name, business address, and business phone number in 
order to receive complaints.
    (iii) An OASIS privacy notice to all patients for whom the OASIS 
data is collected.
    (2) Obtain the patient's or legal representative's signature 
confirming that he or she has received a copy of the notice of rights 
and responsibilities.
    (3) [Reserved]
    (4) Provide written notice of the patient's rights and 
responsibilities under this rule and the HHA's transfer and discharge 
policies as set forth in paragraph (d) of this section to a patient-
selected representative within 4 business days of the initial evaluation 
visit.
    (b) Standard: Exercise of rights. (1) If a patient has been adjudged 
to lack legal capacity to make health care decisions as established by 
state law by a court of proper jurisdiction, the rights of the patient 
may be exercised by the person appointed by the state court to act on 
the patient's behalf.
    (2) If a state court has not adjudged a patient to lack legal 
capacity to make health care decisions as defined by state law, the 
patient's representative may exercise the patient's rights.
    (3) If a patient has been adjudged to lack legal capacity to make 
health care decisions under state law by a court of proper jurisdiction, 
the patient may exercise his or her rights to the extent allowed by 
court order.
    (c) Standard: Rights of the patient. The patient has the right to--
    (1) Have his or her property and person treated with respect;
    (2) Be free from verbal, mental, sexual, and physical abuse, 
including injuries of unknown source, neglect and misappropriation of 
property;

[[Page 159]]

    (3) Make complaints to the HHA regarding treatment or care that is 
(or fails to be) furnished, and the lack of respect for property and/or 
person by anyone who is furnishing services on behalf of the HHA;
    (4) Participate in, be informed about, and consent or refuse care in 
advance of and during treatment, where appropriate, with respect to--
    (i) Completion of all assessments;
    (ii) The care to be furnished, based on the comprehensive 
assessment;
    (iii) Establishing and revising the plan of care;
    (iv) The disciplines that will furnish the care;
    (v) The frequency of visits;
    (vi) Expected outcomes of care, including patient-identified goals, 
and anticipated risks and benefits;
    (vii) Any factors that could impact treatment effectiveness; and
    (viii) Any changes in the care to be furnished.
    (5) Receive all services outlined in the plan of care.
    (6) Have a confidential clinical record. Access to or release of 
patient information and clinical records is permitted in accordance with 
45 CFR parts 160 and 164.
    (7) Be advised, orally and in writing, of--
    (i) The extent to which payment for HHA services may be expected 
from Medicare, Medicaid, or any other federally-funded or federal aid 
program known to the HHA,
    (ii) The charges for services that may not be covered by Medicare, 
Medicaid, or any other federally-funded or federal aid program known to 
the HHA,
    (iii) The charges the individual may have to pay before care is 
initiated; and
    (iv) Any changes in the information provided in accordance with 
paragraph (c)(7) of this section when they occur. The HHA must advise 
the patient and representative (if any), of these changes as soon as 
possible, in advance of the next home health visit. The HHA must comply 
with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 
411.408(f).
    (8) Receive proper written notice, in advance of a specific service 
being furnished, if the HHA believes that the service may be non-covered 
care; or in advance of the HHA reducing or terminating on-going care. 
The HHA must also comply with the requirements of 42 CFR 405.1200 
through 405.1204.
    (9) Be advised of the state toll free home health telephone hot 
line, its contact information, its hours of operation, and that its 
purpose is to receive complaints or questions about local HHAs.
    (10) Be advised of the names, addresses, and telephone numbers of 
the following Federally-funded and state-funded entities that serve the 
area where the patient resides:
    (i) Agency on Aging,
    (ii) Center for Independent Living,
    (iii) Protection and Advocacy Agency,
    (iv) Aging and Disability Resource Center; and
    (v) Quality Improvement Organization.
    (11) Be free from any discrimination or reprisal for exercising his 
or her rights or for voicing grievances to the HHA or an outside entity.
    (12) Be informed of the right to access auxiliary aids and language 
services as described in paragraph (f) of this section, and how to 
access these services.
    (d) Standard: Transfer and discharge. The patient and representative 
(if any), have a right to be informed of the HHA's policies for transfer 
and discharge. The HHA may only transfer or discharge the patient from 
the HHA if:
    (1) The transfer or discharge is necessary for the patient's welfare 
because the HHA and the physician or allowed practitioner who is 
responsible for the home health plan of care agree that the HHA can no 
longer meet the patient's needs, based on the patient's acuity. The HHA 
must arrange a safe and appropriate transfer to other care entities when 
the needs of the patient exceed the HHA's capabilities;
    (2) The patient or payer will no longer pay for the services 
provided by the HHA;
    (3) The transfer or discharge is appropriate because the physician 
or allowed practitioner who is responsible for the home health plan of 
care and the HHA agree that the measurable outcomes and goals set forth 
in the plan of care

[[Page 160]]

in accordance with Sec. 484.60(a)(2)(xiv) have been achieved, and the 
HHA and the physician or allowed practitioner who is responsible for the 
home health plan of care agree that the patient no longer needs the 
HHA's services;
    (4) The patient refuses services, or elects to be transferred or 
discharged;
    (5) The HHA determines, under a policy set by the HHA for the 
purpose of addressing discharge for cause that meets the requirements of 
paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the 
patient's (or other persons in the patient's home) behavior is 
disruptive, abusive, or uncooperative to the extent that delivery of 
care to the patient or the ability of the HHA to operate effectively is 
seriously impaired. The HHA must do the following before it discharges a 
patient for cause:
    (i) Advise the patient, representative (if any), the physician(s) 
issuing orders for the home health plan of care, and the patient's 
primary care practitioner or other health care professional who will be 
responsible for providing care and services to the patient after 
discharge from the HHA (if any) that a discharge for cause is being 
considered;
    (ii) Make efforts to resolve the problem(s) presented by the 
patient's behavior, the behavior of other persons in the patient's home, 
or situation;
    (iii) Provide the patient and representative (if any), with contact 
information for other agencies or providers who may be able to provide 
care; and
    (iv) Document the problem(s) and efforts made to resolve the 
problem(s), and enter this documentation into its clinical records;
    (6) The patient dies; or
    (7) The HHA ceases to operate.
    (e) Standard: Investigation of complaints. (1) The HHA must--
    (i) Investigate complaints made by a patient, the patient's 
representative (if any), and the patient's caregivers and family, 
including, but not limited to, the following topics:
    (A) Treatment or care that is (or fails to be) furnished, is 
furnished inconsistently, or is furnished inappropriately; and
    (B) Mistreatment, neglect, or verbal, mental, sexual, and physical 
abuse, including injuries of unknown source, and/or misappropriation of 
patient property by anyone furnishing services on behalf of the HHA.
    (ii) Document both the existence of the complaint and the resolution 
of the complaint; and
    (iii) Take action to prevent further potential violations, including 
retaliation, while the complaint is being investigated.
    (2) Any HHA staff (whether employed directly or under arrangements) 
in the normal course of providing services to patients, who identifies, 
notices, or recognizes incidences or circumstances of mistreatment, 
neglect, verbal, mental, sexual, and/or physical abuse, including 
injuries of unknown source, or misappropriation of patient property, 
must report these findings immediately to the HHA and other appropriate 
authorities in accordance with state law.
    (f) Standard: Accessibility. Information must be provided to 
patients in plain language and in a manner that is accessible and timely 
to--
    (1) Persons with disabilities, including accessible Web sites and 
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.
    (2) Persons with limited English proficiency through the provision 
of language services at no cost to the individual, including oral 
interpretation and written translations.

[82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 
85 FR 27628, May 8, 2020]



Sec. 484.55  Condition of participation: Comprehensive assessment 
of patients.

    Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment. For Medicare beneficiaries, the HHA 
must verify the patient's eligibility for the Medicare home health 
benefit including homebound status, both at the time of the initial 
assessment visit and at the time of the comprehensive assessment.
    (a) Standard: Initial assessment visit. (1) A registered nurse must 
conduct an initial assessment visit to determine the immediate care and 
support needs

[[Page 161]]

of the patient; and, for Medicare patients, to determine eligibility for 
the Medicare home health benefit, including homebound status. The 
initial assessment visit must be held either within 48 hours of 
referral, or within 48 hours of the patient's return home, or on the 
physician or allowed practitioner-ordered start of care date.
    (2) When rehabilitation therapy service (speech language pathology, 
physical therapy, or occupational therapy) is the only service ordered 
by the physician who is responsible for the home health plan of care, 
and if the need for that service establishes program eligibility, the 
initial assessment visit may be made by the appropriate rehabilitation 
skilled professional.
    (b) Standard: Completion of the comprehensive assessment. (1) The 
comprehensive assessment must be completed in a timely manner, 
consistent with the patient's immediate needs, but no later than 5 
calendar days after the start of care.
    (2) Except as provided in paragraph (b)(3) of this section, a 
registered nurse must complete the comprehensive assessment and for 
Medicare patients, determine eligibility for the Medicare home health 
benefit, including homebound status.
    (3) When physical therapy, speech-language pathology, or 
occupational therapy is the only service ordered by the physician or 
allowed practitioner, a physical therapist, speech-language pathologist 
or occupational therapist may complete the comprehensive assessment, and 
for Medicare patients, determine eligibility for the Medicare home 
health benefit, including homebound status. The occupational therapist 
may complete the comprehensive assessment if the need for occupational 
therapy establishes program eligibility.
    (c) Standard: Content of the comprehensive assessment. The 
comprehensive assessment must accurately reflect the patient's status, 
and must include, at a minimum, the following information:
    (1) The patient's current health, psychosocial, functional, and 
cognitive status;
    (2) The patient's strengths, goals, and care preferences, including 
information that may be used to demonstrate the patient's progress 
toward achievement of the goals identified by the patient and the 
measurable outcomes identified by the HHA;
    (3) The patient's continuing need for home care;
    (4) The patient's medical, nursing, rehabilitative, social, and 
discharge planning needs;
    (5) A review of all medications the patient is currently using in 
order to identify any potential adverse effects and drug reactions, 
including ineffective drug therapy, significant side effects, 
significant drug interactions, duplicate drug therapy, and noncompliance 
with drug therapy.
    (6) The patient's primary caregiver(s), if any, and other available 
supports, including their:
    (i) Willingness and ability to provide care, and
    (ii) Availability and schedules;
    (7) The patient's representative (if any);
    (8) Incorporation of the current version of the Outcome and 
Assessment Information Set (OASIS) items, using the language and 
groupings of the OASIS items, as specified by the Secretary. The OASIS 
data items determined by the Secretary must include: clinical record 
items, demographics and patient history, living arrangements, supportive 
assistance, sensory status, integumentary status, respiratory status, 
elimination status, neuro/emotional/behavioral status, activities of 
daily living, medications, equipment management, emergent care, and data 
items collected at inpatient facility admission or discharge only.
    (d) Standard: Update of the comprehensive assessment. The 
comprehensive assessment must be updated and revised (including the 
administration of the OASIS) as frequently as the patient's condition 
warrants due to a major decline or improvement in the patient's health 
status, but not less frequently than--
    (1) The last 5 days of every 60 days beginning with the start-of-
care date, unless there is a--
    (i) Beneficiary elected transfer;
    (ii) Significant change in condition; or

[[Page 162]]

    (iii) Discharge and return to the same HHA during the 60-day 
episode.
    (2) Within 48 hours of the patient's return to the home from a 
hospital admission of 24 hours or more for any reason other than 
diagnostic tests, or on physician or allowed practitioner-ordered 
resumption date;
    (3) At discharge.

[82 FR 4578, Jan. 13, 2017, as amended at 85 FR 27628, May 8, 2020]



Sec. 484.58  Condition of participation: Discharge planning.

    (a) Standard: Discharge planning. An HHA must develop and implement 
an effective discharge planning process. For patients who are 
transferred to another HHA or who are discharged to a SNF, IRF or LTCH, 
the HHA must assist patients and their caregivers in selecting a post-
acute care provider by using and sharing data that includes, but is not 
limited to HHA, SNF, IRF, or LTCH data on quality measures and data on 
resource use measures. The HHA must ensure that the post-acute care data 
on quality measures and data on resource use measures is relevant and 
applicable to the patient's goals of care and treatment preferences.
    (b) Standard: Discharge or transfer summary content. (1) The HHA 
must send all necessary medical information pertaining to the patient's 
current course of illness and treatment, post-discharge goals of care, 
and treatment preferences, to the receiving facility or health care 
practitioner to ensure the safe and effective transition of care.
    (2) The HHA must comply with requests for additional clinical 
information as may be necessary for treatment of the patient made by the 
receiving facility or health care practitioner.

[84 FR 51883, Sept. 30, 2019]



Sec. 484.60  Condition of participation: Care planning, coordination
of services, and quality of care.

    Patients are accepted for treatment on the reasonable expectation 
that an HHA can meet the patient's medical, nursing, rehabilitative, and 
social needs in his or her place of residence. Each patient must receive 
an individualized written plan of care, including any revisions or 
additions. The individualized plan of care must specify the care and 
services necessary to meet the patient-specific needs as identified in 
the comprehensive assessment, including identification of the 
responsible discipline(s), and the measurable outcomes that the HHA 
anticipates will occur as a result of implementing and coordinating the 
plan of care. The individualized plan of care must also specify the 
patient and caregiver education and training. Services must be furnished 
in accordance with accepted standards of practice.
    (a) Standard: Plan of care. (1) Each patient must receive the home 
health services that are written in an individualized plan of care that 
identifies patient-specific measurable outcomes and goals, and which is 
established, periodically reviewed, and signed by a doctor of medicine, 
osteopathy, or podiatry or allowed practitioner acting within the scope 
of his or her state license, certification, or registration. If a 
physician or allowed practitioner refers a patient under a plan of care 
that cannot be completed until after an evaluation visit, the physician 
or allowed practitioner is consulted to approve additions or 
modifications to the original plan.
    (2) The individualized plan of care must include the following:
    (i) All pertinent diagnoses;
    (ii) The patient's mental, psychosocial, and cognitive status;
    (iii) The types of services, supplies, and equipment required;
    (iv) The frequency and duration of visits to be made;
    (v) Prognosis;
    (vi) Rehabilitation potential;
    (vii) Functional limitations;
    (viii) Activities permitted;
    (ix) Nutritional requirements;
    (x) All medications and treatments;
    (xi) Safety measures to protect against injury;
    (xii) A description of the patient's risk for emergency department 
visits and hospital re-admission, and all necessary interventions to 
address the underlying risk factors.
    (xiii) Patient and caregiver education and training to facilitate 
timely discharge;
    (xiv) Patient-specific interventions and education; measurable 
outcomes

[[Page 163]]

and goals identified by the HHA and the patient;
    (xv) Information related to any advanced directives; and
    (xvi) Any additional items the HHA or physician or allowed 
practitioner may choose to include.
    (3) All patient care orders, including verbal orders, must be 
recorded in the plan of care.
    (b) Standard: Conformance with physician or allowed practitioner 
orders. (1) Drugs, services, and treatments are administered only as 
ordered by a physician or allowed practitioner.
    (2) Influenza and pneumococcal vaccines may be administered per 
agency policy developed in consultation with a physician, physician 
assistant, nurse practitioner, or clinical nurse specialist, and after 
an assessment of the patient to determine for contraindications.
    (3) Verbal orders must be accepted only by personnel authorized to 
do so by applicable state laws and regulations and by the HHA's internal 
policies.
    (4) When services are provided on the basis of a physician or 
allowed practitioner's verbal orders, a nurse acting in accordance with 
state licensure requirements, or other qualified practitioner 
responsible for furnishing or supervising the ordered services, in 
accordance with state law and the HHA's policies, must document the 
orders in the patient's clinical record, and sign, date, and time the 
orders. Verbal orders must be authenticated and dated by the physician 
or allowed practitioner in accordance with applicable state laws and 
regulations, as well as the HHA's internal policies.
    (c) Standard: Review and revision of the plan of care. (1) The 
individualized plan of care must be reviewed and revised by the 
physician or allowed practitioner who is responsible for the home health 
plan of care and the HHA as frequently as the patient's condition or 
needs require, but no less frequently than once every 60 days, beginning 
with the start of care date. The HHA must promptly alert the relevant 
physician(s) or allowed practitioner(s) to any changes in the patient's 
condition or needs that suggest that outcomes are not being achieved 
and/or that the plan of care should be altered.
    (2) A revised plan of care must reflect current information from the 
patient's updated comprehensive assessment, and contain information 
concerning the patient's progress toward the measurable outcomes and 
goals identified by the HHA and patient in the plan of care.
    (3) Revisions to the plan of care must be communicated as follows:
    (i) Any revision to the plan of care due to a change in patient 
health status must be communicated to the patient, representative (if 
any), caregiver, and all physicians or allowed practitioners issuing 
orders for the HHA plan of care.
    (ii) Any revisions related to plans for the patient's discharge must 
be communicated to the patient, representative, caregiver, all 
physicians or allowed practitioners issuing orders for the HHA plan of 
care, and the patient's primary care practitioner or other health care 
professional who will be responsible for providing care and services to 
the patient after discharge from the HHA (if any).
    (d) Standard: Coordination of care. The HHA must:
    (1) Assure communication with all physicians or allowed 
practitioners involved in the plan of care.
    (2) Integrate orders from all physicians or allowed practitioners 
involved in the plan of care to assure the coordination of all services 
and interventions provided to the patient.
    (3) Integrate services, whether services are provided directly or 
under arrangement, to assure the identification of patient needs and 
factors that could affect patient safety and treatment effectiveness and 
the coordination of care provided by all disciplines.
    (4) Coordinate care delivery to meet the patient's needs, and 
involve the patient, representative (if any), and caregiver(s), as 
appropriate, in the coordination of care activities.
    (5) Ensure that each patient, and his or her caregiver(s) where 
applicable, receive ongoing education and training provided by the HHA, 
as appropriate, regarding the care and services identified in the plan 
of care. The HHA must

[[Page 164]]

provide training, as necessary, to ensure a timely discharge.
    (e) Standard: Written information to the patient. The HHA must 
provide the patient and caregiver with a copy of written instructions 
outlining:
    (1) Visit schedule, including frequency of visits by HHA personnel 
and personnel acting on behalf of the HHA.
    (2) Patient medication schedule/instructions, including: medication 
name, dosage and frequency and which medications will be administered by 
HHA personnel and personnel acting on behalf of the HHA.
    (3) Any treatments to be administered by HHA personnel and personnel 
acting on behalf of the HHA, including therapy services.
    (4) Any other pertinent instruction related to the patient's care 
and treatments that the HHA will provide, specific to the patient's care 
needs.
    (5) Name and contact information of the HHA clinical manager.

[82 FR 4578, Jan. 13, 2017, as amended at 85 FR 27628, May 8, 2020]



Sec. 484.65  Condition of participation: Quality assessment 
and performance improvement (QAPI).

    The HHA must develop, implement, evaluate, and maintain an 
effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's 
governing body must ensure that the program reflects the complexity of 
its organization and services; involves all HHA services (including 
those services provided under contract or arrangement); focuses on 
indicators related to improved outcomes, including the use of emergent 
care services, hospital admissions and re-admissions; and takes actions 
that address the HHA's performance across the spectrum of care, 
including the prevention and reduction of medical errors. The HHA must 
maintain documentary evidence of its QAPI program and be able to 
demonstrate its operation to CMS.
    (a) Standard: Program scope. (1) The program must at least be 
capable of showing measurable improvement in indicators for which there 
is evidence that improvement in those indicators will improve health 
outcomes, patient safety, and quality of care.
    (2) The HHA must measure, analyze, and track quality indicators, 
including adverse patient events, and other aspects of performance that 
enable the HHA to assess processes of care, HHA services, and 
operations.
    (b) Standard: Program data. (1) The program must utilize quality 
indicator data, including measures derived from OASIS, where applicable, 
and other relevant data, in the design of its program.
    (2) The HHA must use the data collected to--
    (i) Monitor the effectiveness and safety of services and quality of 
care; and
    (ii) Identify opportunities for improvement.
    (3) The frequency and detail of the data collection must be approved 
by the HHA's governing body.
    (c) Standard: Program activities. (1) The HHA's performance 
improvement activities must--
    (i) Focus on high risk, high volume, or problem-prone areas;
    (ii) Consider incidence, prevalence, and severity of problems in 
those areas; and
    (iii) Lead to an immediate correction of any identified problem that 
directly or potentially threaten the health and safety of patients.
    (2) Performance improvement activities must track adverse patient 
events, analyze their causes, and implement preventive actions.
    (3) The HHA must take actions aimed at performance improvement, and, 
after implementing those actions, the HHA must measure its success and 
track performance to ensure that improvements are sustained.
    (d) Standard: Performance improvement projects. Beginning July 13, 
2018 HHAs must conduct performance improvement projects.
    (1) The number and scope of distinct improvement projects conducted 
annually must reflect the scope, complexity, and past performance of the 
HHA's services and operations.
    (2) The HHA must document the quality improvement projects 
undertaken, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.

[[Page 165]]

    (e) Standard: Executive responsibilities. The HHA's governing body 
is responsible for ensuring the following:
    (1) That an ongoing program for quality improvement and patient 
safety is defined, implemented, and maintained;
    (2) That the HHA-wide quality assessment and performance improvement 
efforts address priorities for improved quality of care and patient 
safety, and that all improvement actions are evaluated for 
effectiveness;
    (3) That clear expectations for patient safety are established, 
implemented, and maintained; and
    (4) That any findings of fraud or waste are appropriately addressed.

[82 FR 4578, Jan. 13, 2017, as amended at 82 FR 31732, July 10, 2017]



Sec. 484.70  Condition of participation: Infection prevention 
and control.

    The HHA must maintain and document an infection control program 
which has as its goal the prevention and control of infections and 
communicable diseases.
    (a) Standard: Prevention. The HHA must follow accepted standards of 
practice, including the use of standard precautions, to prevent the 
transmission of infections and communicable diseases.
    (b) Standard: Control. The HHA must maintain a coordinated agency-
wide program for the surveillance, identification, prevention, control, 
and investigation of infectious and communicable diseases that is an 
integral part of the HHA's quality assessment and performance 
improvement (QAPI) program. The infection control program must include:
    (1) A method for identifying infectious and communicable disease 
problems; and
    (2) A plan for the appropriate actions that are expected to result 
in improvement and disease prevention.
    (c) Standard: Education. The HHA must provide infection control 
education to staff, patients, and caregiver(s).



Sec. 484.75  Condition of participation: Skilled professional 
services.

    Skilled professional services include skilled nursing services, 
physical therapy, speech-language pathology services, and occupational 
therapy, as specified in Sec. 409.44 of this chapter, and physician or 
allowed practitioner and medical social work services as specified in 
Sec. 409.45 of this chapter. Skilled professionals who provide services 
to HHA patients directly or under arrangement must participate in the 
coordination of care.
    (a) Standard: Provision of services by skilled professionals. 
Skilled professional services are authorized, delivered, and supervised 
only by health care professionals who meet the appropriate 
qualifications specified under Sec. 484.115 and who practice according 
to the HHA's policies and procedures.
    (b) Standard: Responsibilities of skilled professionals. Skilled 
professionals must assume responsibility for, but not be restricted to, 
the following:
    (1) Ongoing interdisciplinary assessment of the patient;
    (2) Development and evaluation of the plan of care in partnership 
with the patient, representative (if any), and caregiver(s);
    (3) Providing services that are ordered by the physician or allowed 
practitioner as indicated in the plan of care;
    (4) Patient, caregiver, and family counseling;
    (5) Patient and caregiver education;
    (6) Preparing clinical notes;
    (7) Communication with all physicians involved in the plan of care 
and other health care practitioners (as appropriate) related to the 
current plan of care;
    (8) Participation in the HHA's QAPI program; and
    (9) Participation in HHA-sponsored in-service training.
    (c) Supervision of skilled professional assistants. (1) Nursing 
services are provided under the supervision of a registered nurse that 
meets the requirements of Sec. 484.115(k).
    (2) Rehabilitative therapy services are provided under the 
supervision of an occupational therapist or physical therapist that 
meets the requirements of Sec. 484.115(f) or (h), respectively.
    (3) Medical social services are provided under the supervision of a 
social

[[Page 166]]

worker that meets the requirements of Sec. 484.115(m).

[82 FR 4578, Jan. 13, 2017, as amended at 85 FR 27628, May 8, 2020]



Sec. 484.80  Condition of participation: Home health aide services.

    All home health aide services must be provided by individuals who 
meet the personnel requirements specified in paragraph (a) of this 
section.
    (a) Standard: Home health aide qualifications. (1) A qualified home 
health aide is a person who has successfully completed:
    (i) A training and competency evaluation program as specified in 
paragraphs (b) and (c) respectively of this section; or
    (ii) A competency evaluation program that meets the requirements of 
paragraph (c) of this section; or
    (iii) A nurse aide training and competency evaluation program 
approved by the state as meeting the requirements of Sec. 483.151 
through Sec. 483.154 of this chapter, and is currently listed in good 
standing on the state nurse aide registry; or
    (iv) The requirements of a state licensure program that meets the 
provisions of paragraphs (b) and (c) of this section.
    (2) A home health aide or nurse aide is not considered to have 
completed a program, as specified in paragraph (a)(1) of this section, 
if, since the individual's most recent completion of the program(s), 
there has been a continuous period of 24 consecutive months during which 
none of the services furnished by the individual as described in Sec. 
409.40 of this chapter were for compensation. If there has been a 24-
month lapse in furnishing services for compensation, the individual must 
complete another program, as specified in paragraph (a)(1) of this 
section, before providing services.
    (b) Standard: Content and duration of home health aide classroom and 
supervised practical training. (1) Home health aide training must 
include classroom and supervised practical training in a practicum 
laboratory or other setting in which the trainee demonstrates knowledge 
while providing services to an individual under the direct supervision 
of a registered nurse, or a licensed practical nurse who is under the 
supervision of a registered nurse. Classroom and supervised practical 
training must total at least 75 hours.
    (2) A minimum of 16 hours of classroom training must precede a 
minimum of 16 hours of supervised practical training as part of the 75 
hours.
    (3) A home health aide training program must address each of the 
following subject areas:
    (i) Communication skills, including the ability to read, write, and 
verbally report clinical information to patients, representatives, and 
caregivers, as well as to other HHA staff.
    (ii) Observation, reporting, and documentation of patient status and 
the care or service furnished.
    (iii) Reading and recording temperature, pulse, and respiration.
    (iv) Basic infection prevention and control procedures.
    (v) Basic elements of body functioning and changes in body function 
that must be reported to an aide's supervisor.
    (vi) Maintenance of a clean, safe, and healthy environment.
    (vii) Recognizing emergencies and the knowledge of instituting 
emergency procedures and their application.
    (viii) The physical, emotional, and developmental needs of and ways 
to work with the populations served by the HHA, including the need for 
respect for the patient, his or her privacy, and his or her property.
    (ix) Appropriate and safe techniques in performing personal hygiene 
and grooming tasks that include--
    (A) Bed bath;
    (B) Sponge, tub, and shower bath;
    (C) Hair shampooing in sink, tub, and bed;
    (D) Nail and skin care;
    (E) Oral hygiene;
    (F) Toileting and elimination;
    (x) Safe transfer techniques and ambulation;
    (xi) Normal range of motion and positioning;
    (xii) Adequate nutrition and fluid intake;
    (xiii) Recognizing and reporting changes in skin condition; and
    (xiv) Any other task that the HHA may choose to have an aide perform 
as permitted under state law.

[[Page 167]]

    (xv) The HHA is responsible for training home health aides, as 
needed, for skills not covered in the basic checklist, as described in 
paragraph (b)(3)(ix) of this section.
    (4) The HHA must maintain documentation that demonstrates that the 
requirements of this standard have been met.
    (c) Standard: Competency evaluation. An individual may furnish home 
health services on behalf of an HHA only after that individual has 
successfully completed a competency evaluation program as described in 
this section.
    (1) The competency evaluation must address each of the subjects 
listed in paragraph (b)(3) of this section. Subject areas specified 
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section 
must be evaluated by observing an aide's performance of the task with a 
patient or pseudo-patient. The remaining subject areas may be evaluated 
through written examination, oral examination, or after observation of a 
home health aide with a patient, or with a pseudo-patient as part of a 
simulation.
    (2) A home health aide competency evaluation program may be offered 
by any organization, except as specified in paragraph (f) of this 
section.
    (3) The competency evaluation must be performed by a registered 
nurse in consultation with other skilled professionals, as appropriate.
    (4) A home health aide is not considered competent in any task for 
which he or she is evaluated as unsatisfactory. An aide must not perform 
that task without direct supervision by a registered nurse until after 
he or she has received training in the task for which he or she was 
evaluated as ``unsatisfactory,'' and has successfully completed a 
subsequent evaluation. A home health aide is not considered to have 
successfully passed a competency evaluation if the aide has an 
``unsatisfactory'' rating in more than one of the required areas.
    (5) The HHA must maintain documentation which demonstrates that the 
requirements of this standard have been met.
    (d) Standard: In-service training. A home health aide must receive 
at least 12 hours of in-service training during each 12-month period. 
In-service training may occur while an aide is furnishing care to a 
patient.
    (1) In-service training may be offered by any organization and must 
be supervised by a registered nurse.
    (2) The HHA must maintain documentation that demonstrates the 
requirements of this standard have been met.
    (e) Standard: Qualifications for instructors conducting classroom 
and supervised practical training. Classroom and supervised practical 
training must be performed by a registered nurse who possesses a minimum 
of 2 years nursing experience, at least 1 year of which must be in home 
health care, or by other individuals under the general supervision of 
the registered nurse.
    (f) Standard: Eligible training and competency evaluation 
organizations. A home health aide training program and competency 
evaluation program may be offered by any organization except by an HHA 
that, within the previous 2 years:
    (1) Was out of compliance with the requirements of paragraphs (b), 
(c), (d), or (e) of this section; or
    (2) Permitted an individual who does not meet the definition of a 
``qualified home health aide'' as specified in paragraph (a) of this 
section to furnish home health aide services (with the exception of 
licensed health professionals and volunteers); or
    (3) Was subjected to an extended (or partially extended) survey as a 
result of having been found to have furnished substandard care (or for 
other reasons as determined by CMS or the state); or
    (4) Was assessed a civil monetary penalty of $5,000 or more as an 
intermediate sanction; or
    (5) Was found to have compliance deficiencies that endangered the 
health and safety of the HHA's patients, and had temporary management 
appointed to oversee the management of the HHA; or
    (6) Had all or part of its Medicare payments suspended; or
    (7) Was found under any federal or state law to have:
    (i) Had its participation in the Medicare program terminated; or

[[Page 168]]

    (ii) Been assessed a penalty of $5,000 or more for deficiencies in 
federal or state standards for HHAs; or
    (iii) Been subjected to a suspension of Medicare payments to which 
it otherwise would have been entitled; or
    (iv) Operated under temporary management that was appointed to 
oversee the operation of the HHA and to ensure the health and safety of 
the HHA's patients; or
    (v) Been closed, or had its patients transferred by the state; or
    (vi) Been excluded from participating in federal health care 
programs or debarred from participating in any government program.
    (g) Standard: Home health aide assignments and duties. (1) Home 
health aides are assigned to a specific patient by a registered nurse or 
other appropriate skilled professional, with written patient care 
instructions for a home health aide prepared by that registered nurse or 
other appropriate skilled professional (that is, physical therapist, 
speech-language pathologist, or occupational therapist).
    (2) A home health aide provides services that are:
    (i) Ordered by the physician or allowed practitioner;
    (ii) Included in the plan of care;
    (iii) Permitted to be performed under state law; and
    (iv) Consistent with the home health aide training.
    (3) The duties of a home health aide include:
    (i) The provision of hands-on personal care;
    (ii) The performance of simple procedures as an extension of therapy 
or nursing services;
    (iii) Assistance in ambulation or exercises; and
    (iv) Assistance in administering medications ordinarily self-
administered.
    (4) Home health aides must be members of the interdisciplinary team, 
must report changes in the patient's condition to a registered nurse or 
other appropriate skilled professional, and must complete appropriate 
records in compliance with the HHA's policies and procedures.
    (h) Standard: Supervision of home health aides. (1)(i) If home 
health aide services are provided to a patient who is receiving skilled 
nursing, physical or occupational therapy, or speech-language pathology 
services, a registered nurse or other appropriate skilled professional 
who is familiar with the patient, the patient's plan of care, and the 
written patient care instructions described in Sec. 484.80(g), must 
make an onsite visit to the patient's home no less frequently than every 
14 days. The home health aide does not have to be present during this 
visit.
    (ii) If an area of concern in aide services is noted by the 
supervising registered nurse or other appropriate skilled professional, 
then the supervising individual must make an on-site visit to the 
location where the patient is receiving care in order to observe and 
assess the aide while he or she is performing care.
    (iii) A registered nurse or other appropriate skilled professional 
must make an annual on-site visit to the location where a patient is 
receiving care in order to observe and assess each aide while he or she 
is performing care.
    (2) If home health aide services are provided to a patient who is 
not receiving skilled nursing care, physical or occupational therapy, or 
speech-language pathology services, the registered nurse must make an 
on-site visit to the location where the patient is receiving care no 
less frequently than every 60 days in order to observe and assess each 
aide while he or she is performing care.
    (3) If a deficiency in aide services is verified by the registered 
nurse or other appropriate skilled professional during an on-site visit, 
then the agency must conduct, and the home health aide must complete, 
retraining and a competency evaluation related to the deficient 
skill(s).
    (4) Home health aide supervision must ensure that aides furnish care 
in a safe and effective manner, including, but not limited to, the 
following elements:
    (i) Following the patient's plan of care for completion of tasks 
assigned to a home health aide by the registered nurse or other 
appropriate skilled professional;

[[Page 169]]

    (ii) Maintaining an open communication process with the patient, 
representative (if any), caregivers, and family;
    (iii) Demonstrating competency with assigned tasks;
    (iv) Complying with infection prevention and control policies and 
procedures;
    (v) Reporting changes in the patient's condition; and
    (vi) Honoring patient rights.
    (5) If the home health agency chooses to provide home health aide 
services under arrangements, as defined in section 1861(w)(1) of the 
Act, the HHA's responsibilities also include, but are not limited to:
    (i) Ensuring the overall quality of care provided by an aide;
    (ii) Supervising aide services as described in paragraphs (h)(1) and 
(2) of this section; and
    (iii) Ensuring that home health aides who provide services under 
arrangement have met the training or competency evaluation requirements, 
or both, of this part.
    (i) Standard: Individuals furnishing Medicaid personal care aide-
only services under a Medicaid personal care benefit. An individual may 
furnish personal care services, as defined in Sec. 440.167 of this 
chapter, on behalf of an HHA. Before the individual may furnish personal 
care services, the individual must meet all qualification standards 
established by the state. The individual only needs to demonstrate 
competency in the services the individual is required to furnish.

[82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 
85 FR 27628, May 8, 2020]



                  Subpart C_Organizational Environment

    Source: 82 FR 4578, Jan. 13, 2017, unless otherwise noted.



Sec. 484.100  Condition of participation: Compliance with Federal, 
State, and local laws and regulations related to the health and
safety of patients.

    The HHA and its staff must operate and furnish services in 
compliance with all applicable federal, state, and local laws and 
regulations related to the health and safety of patients. If state or 
local law provides licensing of HHAs, the HHA must be licensed.
    (a) Standard: Disclosure of ownership and management information. 
The HHA must comply with the requirements of part 420 subpart C, of this 
chapter. The HHA also must disclose the following information to the 
state survey agency at the time of the HHA's initial request for 
certification, for each survey, and at the time of any change in 
ownership or management:
    (1) The names and addresses of all persons with an ownership or 
controlling interest in the HHA as defined in Sec. 420.201, Sec. 
420.202, and Sec. 420.206 of this chapter.
    (2) The name and address of each person who is an officer, a 
director, an agent, or a managing employee of the HHA as defined in 
Sec. 420.201, Sec. 420.202, and Sec. 420.206 of this chapter.
    (3) The name and business address of the corporation, association, 
or other company that is responsible for the management of the HHA, and 
the names and addresses of the chief executive officer and the 
chairperson of the board of directors of that corporation, association, 
or other company responsible for the management of the HHA.
    (b) Standard: Licensing. The HHA, its branches, and all persons 
furnishing services to patients must be licensed, certified, or 
registered, as applicable, in accordance with the state licensing 
authority as meeting those requirements.
    (c) Standard: Laboratory services. (1) If the HHA engages in 
laboratory testing outside of the context of assisting an individual in 
self-administering a test with an appliance that has been cleared for 
that purpose by the Food and Drug Administration, the testing must be in 
compliance with all applicable requirements of part 493 of this chapter. 
The HHA may not substitute its equipment for a patient's equipment when 
assisting with self-administered tests.
    (2) If the HHA refers specimens for laboratory testing, the referral 
laboratory must be certified in the appropriate specialties and 
subspecialties of services in accordance with the applicable 
requirements of part 493 of this chapter.

[[Page 170]]



Sec. 484.102  Condition of participation: Emergency preparedness.

    The Home Health Agency (HHA) must comply with all applicable 
Federal, State, and local emergency preparedness requirements. The HHA 
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 HHA must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the HHA 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 HHA 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 plans for the HHA's patients during a natural or man-made 
disaster. Individual plans for each patient must be included as part of 
the comprehensive patient assessment, which must be conducted according 
to the provisions at Sec. 484.55.
    (2) The procedures to inform State and local emergency preparedness 
officials about HHA patients in need of evacuation from their residences 
at any time due to an emergency situation based on the patient's medical 
and psychiatric condition and home environment.
    (3) The procedures to follow up with on-duty staff and patients to 
determine services that are needed, in the event that there is an 
interruption in services during or due to an emergency. The HHA must 
inform State and local officials of any on-duty staff or patients that 
they are unable to contact.
    (4) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (5) 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.
    (c) Communication plan. The HHA 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) Patients' physicians.
    (iv) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, or local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the HHA's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
patients under the HHA's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means of providing information about the general condition and 
location of patients under the facility's

[[Page 171]]

care as permitted under 45 CFR 164.510(b)(4).
    (6) A means of providing information about the HHA's needs, and its 
ability to provide assistance, to the authority having jurisdiction, the 
Incident Command Center, or designee.
    (d) Training and testing. The HHA 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 HHA must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the HHA must conduct training on the updated 
policies and procedures.
    (2) Testing. The HHA must conduct exercises to test the emergency 
plan at least annually. The HHA 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 HHA experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the HHA 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 HHA's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
HHA's emergency plan, as needed.
    (e) Integrated healthcare systems. If a HHA 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 HHA may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of 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 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.

[[Page 172]]

    (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.

[82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019]



Sec. 484.105  Condition of participation: Organization and 
administration of services.

    The HHA must organize, manage, and administer its resources to 
attain and maintain the highest practicable functional capacity, 
including providing optimal care to achieve the goals and outcomes 
identified in the patient's plan of care, for each patient's medical, 
nursing, and rehabilitative needs. The HHA must assure that 
administrative and supervisory functions are not delegated to another 
agency or organization, and all services not furnished directly are 
monitored and controlled. The HHA must set forth, in writing, its 
organizational structure, including lines of authority, and services 
furnished.
    (a) Standard: Governing body. A governing body (or designated 
persons so functioning) must assume full legal authority and 
responsibility for the agency's overall management and operation, the 
provision of all home health services, fiscal operations, review of the 
agency's budget and its operational plans, and its quality assessment 
and performance improvement program.
    (b) Standard: Administrator. (1) The administrator must:
    (i) Be appointed by and report to the governing body;
    (ii) Be responsible for all day-to-day operations of the HHA;
    (iii) Ensure that a clinical manager as described in paragraph (c) 
of this section is available during all operating hours;
    (iv) Ensure that the HHA employs qualified personnel, including 
assuring the development of personnel qualifications and policies.
    (2) When the administrator is not available, a qualified, pre-
designated person, who is authorized in writing by the administrator and 
the governing body, assumes the same responsibilities and obligations as 
the administrator. The pre-designated person may be the clinical manager 
as described in paragraph (c) of this section.
    (3) The administrator or a pre-designated person is available during 
all operating hours.
    (c) Clinical manager. One or more qualified individuals must provide 
oversight of all patient care services and personnel. Oversight must 
include the following--
    (1) Making patient and personnel assignments,
    (2) Coordinating patient care,
    (3) Coordinating referrals,
    (4) Assuring that patient needs are continually assessed, and
    (5) Assuring the development, implementation, and updates of the 
individualized plan of care.
    (d) Standard: Parent-branch relationship. (1) The parent HHA is 
responsible for reporting all branch locations of the HHA to the state 
survey agency at the time of the HHA's request for initial 
certification, at each survey, and at the time the parent proposes to 
add or delete a branch.
    (2) The parent HHA provides direct support and administrative 
control of its branches.
    (e) Standard: Services under arrangement. (1) The HHA must ensure 
that all services furnished under arrangement provided by other entities 
or individuals meet the requirements of this part and the requirements 
of section 1861(w) of the Act (42 U.S.C. 1395x (w)).
    (2) An HHA must have a written agreement with another agency, with 
an organization, or with an individual when that entity or individual 
furnishes services under arrangement to the HHA's patients. The HHA must 
maintain overall responsibility for the services provided under 
arrangement, as well as the manner in which they are furnished. The 
agency, organization, or individual providing services under arrangement 
may not have been:

[[Page 173]]

    (i) Denied Medicare or Medicaid enrollment;
    (ii) Been excluded or terminated from any federal health care 
program or Medicaid;
    (iii) Had its Medicare or Medicaid billing privileges revoked; or
    (iv) Been debarred from participating in any government program.
    (3) The primary HHA is responsible for patient care, and must 
conduct and provide, either directly or under arrangements, all services 
rendered to patients.
    (f) Standard: Services furnished. (1) Skilled nursing services and 
at least one other therapeutic service (physical therapy, speech-
language pathology, or occupational therapy; medical social services; or 
home health aide services) are made available on a visiting basis, in a 
place of residence used as a patient's home. An HHA must provide at 
least one of the services described in this subsection directly, but may 
provide the second service and additional services under arrangement 
with another agency or organization.
    (2) All HHA services must be provided in accordance with current 
clinical practice guidelines and accepted professional standards of 
practice.
    (g) Standard: Outpatient physical therapy or speech-language 
pathology services. An HHA that furnishes outpatient physical therapy or 
speech-language pathology services must meet all of the applicable 
conditions of this part and the additional health and safety 
requirements set forth in Sec. 485.711, Sec. 485.713, Sec. 485.715, 
Sec. 485.719, Sec. 485.723, and Sec. 485.727 of this chapter to 
implement section 1861(p) of the Act.
    (h) Standard: Institutional planning. The HHA, under the direction 
of the governing body, prepares an overall plan and a budget that 
includes an annual operating budget and capital expenditure plan.
    (1) Annual operating budget. There is an annual operating budget 
that includes all anticipated income and expenses related to items that 
would, under generally accepted accounting principles, be considered 
income and expense items. However, it is not required that there be 
prepared, in connection with any budget, an item by item identification 
of the components of each type of anticipated income or expense.
    (2) Capital expenditure plan. (i) There is a capital expenditure 
plan for at least a 3-year period, including the operating budget year. 
The plan includes and identifies in detail the anticipated sources of 
financing for, and the objectives of, each anticipated expenditure of 
more than $600,000 for items that would under generally accepted 
accounting principles, be considered capital items. In determining if a 
single capital expenditure exceeds $600,000, the cost of studies, 
surveys, designs, plans, working drawings, specifications, and other 
activities essential to the acquisition, improvement, modernization, 
expansion, or replacement of land, plant, building, and equipment are 
included. Expenditures directly or indirectly related to capital 
expenditures, such as grading, paving, broker commissions, taxes 
assessed during the construction period, and costs involved in 
demolishing or razing structures on land are also included. Transactions 
that are separated in time, but are components of an overall plan or 
patient care objective, are viewed in their entirety without regard to 
their timing. Other costs related to capital expenditures include title 
fees, permit and license fees, broker commissions, architect, legal, 
accounting, and appraisal fees; interest, finance, or carrying charges 
on bonds, notes and other costs incurred for borrowing funds.
    (ii) If the anticipated source of financing is, in any part, the 
anticipated payment from title V (Maternal and Child Health Services 
Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the 
Social Security Act, the plan specifies the following:
    (A) Whether the proposed capital expenditure is required to conform, 
or is likely to be required to conform, to current standards, criteria, 
or plans developed in accordance with the Public Health Service Act or 
the Mental Retardation Facilities and Community Mental Health Centers 
Construction Act of 1963.
    (B) Whether a capital expenditure proposal has been submitted to the 
designated planning agency for approval in accordance with section 1122 
of the

[[Page 174]]

Act (42 U.S.C. 1320a-1) and implementing regulations.
    (C) Whether the designated planning agency has approved or 
disapproved the proposed capital expenditure if it was presented to that 
agency.
    (3) Preparation of plan and budget. The overall plan and budget is 
prepared under the direction of the governing body of the HHA by a 
committee consisting of representatives of the governing body, the 
administrative staff, and the medical staff (if any) of the HHA.
    (4) Annual review of plan and budget. The overall plan and budget is 
reviewed and updated at least annually by the committee referred to in 
paragraph (i)(3) of this section under the direction of the governing 
body of the HHA.



Sec. 484.110  Condition of participation: Clinical records.

    The HHA must maintain a clinical record containing past and current 
information for every patient accepted by the HHA and receiving home 
health services. Information contained in the clinical record must be 
accurate, adhere to current clinical record documentation standards of 
practice, and be available to the physician(s) or allowed 
practitioner(s) issuing orders for the home health plan of care, and 
appropriate HHA staff. This information may be maintained 
electronically.
    (a) Standard: Contents of clinical record. The record must include:
    (1) The patient's current comprehensive assessment, including all of 
the assessments from the most recent home health admission, clinical 
notes, plans of care, and physician or allowed practitioner orders;
    (2) All interventions, including medication administration, 
treatments, and services, and responses to those interventions;
    (3) Goals in the patient's plans of care and the patient's progress 
toward achieving them;
    (4) Contact information for the patient, the patient's 
representative (if any), and the patient's primary caregiver(s);
    (5) Contact information for the primary care practitioner or other 
health care professional who will be responsible for providing care and 
services to the patient after discharge from the HHA; and
    (6)(i) A completed discharge summary that is sent to the primary 
care practitioner or other health care professional who will be 
responsible for providing care and services to the patient after 
discharge from the HHA (if any) within 5 business days of the patient's 
discharge; or
    (ii) A completed transfer summary that is sent within 2 business 
days of a planned transfer, if the patient's care will be immediately 
continued in a health care facility; or
    (iii) A completed transfer summary that is sent within 2 business 
days of becoming aware of an unplanned transfer, if the patient is still 
receiving care in a health care facility at the time when the HHA 
becomes aware of the transfer.
    (b) Standard: Authentication. All entries must be legible, clear, 
complete, and appropriately authenticated, dated, and timed. 
Authentication must include a signature and a title (occupation), or a 
secured computer entry by a unique identifier, of a primary author who 
has reviewed and approved the entry.
    (c) Standard: Retention of records. (1) Clinical records must be 
retained for 5 years after the discharge of the patient, unless state 
law stipulates a longer period of time.
    (2) The HHA's policies must provide for retention of clinical 
records even if it discontinues operation. When an HHA discontinues 
operation, it must inform the state agency where clinical records will 
be maintained.
    (d) Standard: Protection of records. The clinical record, its 
contents, and the information contained therein must be safeguarded 
against loss or unauthorized use. The HHA must be in compliance with the 
rules regarding protected health information set out at 45 CFR parts 160 
and 164.
    (e) Standard: Retrieval of clinical records. A patient's clinical 
record (whether hard copy or electronic form) must be made available to 
a patient, free of charge, upon request at the next home visit, or 
within 4 business days (whichever comes first).

[82 FR 4578, Jan. 13, 2017, as amended at 85 FR 70356, Nov. 4, 2020]

[[Page 175]]



Sec. 484.115  Condition of participation: Personnel qualifications.

    HHA staff are required to meet the following standards:
    (a) Standard: Administrator, home health agency. (1) For individuals 
that began employment with the HHA prior to January 13, 2018, a person 
who:
    (i) Is a licensed physician;
    (ii) Is a registered nurse; or
    (iii) Has training and experience in health service administration 
and at least 1 year of supervisory administrative experience in home 
health care or a related health care program.
    (2) For individuals that begin employment with an HHA on or after 
January 13, 2018, a person who:
    (i) Is a licensed physician, a registered nurse, or holds an 
undergraduate degree; and
    (ii) Has experience in health service administration, with at least 
1 year of supervisory or administrative experience in home health care 
or a related health care program.
    (b) Standard: Audiologist. A person who:
    (1) Meets the education and experience requirements for a 
Certificate of Clinical Competence in audiology granted by the American 
Speech-Language-Hearing Association; or
    (2) Meets the educational requirements for certification and is in 
the process of accumulating the supervised experience required for 
certification.
    (c) Standard: Clinical manager. A person who is a licensed 
physician, physical therapist, speech-language pathologist, occupational 
therapist, audiologist, social worker, or a registered nurse.
    (d) Standard: Home health aide. A person who meets the 
qualifications for home health aides specified in section 1891(a)(3) of 
the Act and implemented at Sec. 484.80.
    (e) Standard: Licensed practical (vocational) nurse. A person who 
has completed a practical (vocational) nursing program, is licensed in 
the state where practicing, and who furnishes services under the 
supervision of a qualified registered nurse.
    (f) Standard: Occupational therapist. A person who--
    (1)(i) Is licensed or otherwise regulated, if applicable, as an 
occupational therapist by the state in which practicing, unless 
licensure does not apply;
    (ii) Graduated after successful completion of an occupational 
therapist education program accredited by the Accreditation Council for 
Occupational Therapy Education (ACOTE) of the American Occupational 
Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; 
and
    (iii) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed 
and administered by the National Board for Certification in Occupational 
Therapy, Inc. (NBCOT).
    (2) On or before December 31, 2009--
    (i) Is licensed or otherwise regulated, if applicable, as an 
occupational therapist by the state in which practicing; or
    (ii) When licensure or other regulation does not apply--
    (A) Graduated after successful completion of an occupational 
therapist education program accredited by the accreditation Council for 
Occupational Therapy Education (ACOTE) of the American Occupational 
Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; 
and
    (B) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed 
and administered by the National Board for Certification in Occupational 
Therapy, Inc., (NBCOT).
    (3) On or before January 1, 2008--
    (i) Graduated after successful completion of an occupational therapy 
program accredited jointly by the Committee on Allied Health Education 
and Accreditation of the American Medical Association and the American 
Occupational Therapy Association; or
    (ii) Is eligible for the National Registration Examination of the 
American Occupational Therapy Association or the National Board for 
Certification in Occupational Therapy.
    (4) On or before December 31, 1977--
    (i) Had 2 years of appropriate experience as an occupational 
therapist; and

[[Page 176]]

    (ii) Had achieved a satisfactory grade on an occupational therapist 
proficiency examination conducted, approved, or sponsored by the U.S. 
Public Health Service.
    (5) If educated outside the United States, must meet both of the 
following:
    (i) Graduated after successful completion of an occupational 
therapist education program accredited as substantially equivalent to 
occupational therapist entry level education in the United States by one 
of the following:
    (A) The Accreditation Council for Occupational Therapy Education 
(ACOTE).
    (B) Successor organizations of ACOTE.
    (C) The World Federation of Occupational Therapists.
    (D) A credentialing body approved by the American Occupational 
Therapy Association.
    (E) Successfully completed the entry level certification examination 
for occupational therapists developed and administered by the National 
Board for Certification in Occupational Therapy, Inc. (NBCOT).
    (ii) On or before December 31, 2009, is licensed or otherwise 
regulated, if applicable, as an occupational therapist by the state in 
which practicing.
    (g) Standard: Occupational therapy assistant. A person who--
    (1) Meets all of the following:
    (i) Is licensed or otherwise regulated, if applicable, as an 
occupational therapy assistant by the state in which practicing, unless 
licensure does apply.
    (ii) Graduated after successful completion of an occupational 
therapy assistant education program accredited by the Accreditation 
Council for Occupational Therapy Education, (ACOTE) of the American 
Occupational Therapy Association, Inc. (AOTA) or its successor 
organizations.
    (iii) Is eligible to take or successfully completed the entry-level 
certification examination for occupational therapy assistants developed 
and administered by the National Board for Certification in Occupational 
Therapy, Inc. (NBCOT).
    (2) On or before December 31, 2009--
    (i) Is licensed or otherwise regulated as an occupational therapy 
assistant, if applicable, by the state in which practicing; or any 
qualifications defined by the state in which practicing, unless 
licensure does not apply; or
    (ii) Must meet both of the following:
    (A) Completed certification requirements to practice as an 
occupational therapy assistant established by a credentialing 
organization approved by the American Occupational Therapy Association.
    (B) After January 1, 2010, meets the requirements in paragraph 
(f)(1) of this section.
    (3) After December 31, 1977 and on or before December 31, 2007--
    (i) Completed certification requirements to practice as an 
occupational therapy assistant established by a credentialing 
organization approved by the American Occupational Therapy Association; 
or
    (ii) Completed the requirements to practice as an occupational 
therapy assistant applicable in the state in which practicing.
    (4) On or before December 31, 1977--
    (i) Had 2 years of appropriate experience as an occupational therapy 
assistant; and
    (ii) Had achieved a satisfactory grade on an occupational therapy 
assistant proficiency examination conducted, approved, or sponsored by 
the U.S. Public Health Service.
    (5) If educated outside the United States, on or after January 1, 
2008--
    (i) Graduated after successful completion of an occupational therapy 
assistant education program that is accredited as substantially 
equivalent to occupational therapist assistant entry level education in 
the United States by--
    (A) The Accreditation Council for Occupational Therapy Education 
(ACOTE).
    (B) Its successor organizations.
    (C) The World Federation of Occupational Therapists.
    (D) By a credentialing body approved by the American Occupational 
Therapy Association; and
    (E) Successfully completed the entry level certification examination 
for occupational therapy assistants developed and administered by the 
National Board for Certification in Occupational Therapy, Inc. (NBCOT).

[[Page 177]]

    (ii) [Reserved]
    (h) Standard: Physical therapist. A person who is licensed, if 
applicable, by the state in which practicing, unless licensure does not 
apply and meets one of the following requirements:
    (1)(i) Graduated after successful completion of a physical therapist 
education program approved by one of the following:
    (A) The Commission on Accreditation in Physical Therapy Education 
(CAPTE).
    (B) Successor organizations of CAPTE.
    (C) An education program outside the United States determined to be 
substantially equivalent to physical therapist entry level education in 
the United States by a credentials evaluation organization approved by 
the American Physical Therapy Association or an organization identified 
in 8 CFR 212.15(e) as it relates to physical therapists.
    (ii) Passed an examination for physical therapists approved by the 
state in which physical therapy services are provided.
    (2) On or before December 31, 2009--
    (i) Graduated after successful completion of a physical therapy 
curriculum approved by the Commission on Accreditation in Physical 
Therapy Education (CAPTE); or
    (ii) Meets both of the following:
    (A) Graduated after successful completion of an education program 
determined to be substantially equivalent to physical therapist entry 
level education in the United States by a credentials evaluation 
organization approved by the American Physical Therapy Association or 
identified in 8 CFR 212.15(e) as it relates to physical therapists.
    (B) Passed an examination for physical therapists approved by the 
state in which physical therapy services are provided.
    (3) Before January 1, 2008 graduated from a physical therapy 
curriculum approved by one of the following:
    (i) The American Physical Therapy Association.
    (ii) The Committee on Allied Health Education and Accreditation of 
the American Medical Association.
    (iii) The Council on Medical Education of the American Medical 
Association and the American Physical Therapy Association.
    (4) On or before December 31, 1977 was licensed or qualified as a 
physical therapist and meets both of the following:
    (i) Has 2 years of appropriate experience as a physical therapist.
    (ii) Has achieved a satisfactory grade on a proficiency examination 
conducted, approved, or sponsored by the U.S. Public Health Service.
    (5) Before January 1, 1966--
    (i) Was admitted to membership by the American Physical Therapy 
Association;
    (ii) Was admitted to registration by the American Registry of 
Physical Therapists; or
    (iii) Graduated from a physical therapy curriculum in a 4-year 
college or university approved by a state department of education.
    (6) Before January 1, 1966 was licensed or registered, and before 
January 1, 1970, had 15 years of fulltime experience in the treatment of 
illness or injury through the practice of physical therapy in which 
services were rendered under the order and direction of attending and 
referring doctors of medicine or osteopathy.
    (7) If trained outside the United States before January 1, 2008, 
meets the following requirements:
    (i) Was graduated since 1928 from a physical therapy curriculum 
approved in the country in which the curriculum was located and in which 
there is a member organization of the World Confederation for Physical 
Therapy.
    (ii) Meets the requirements for membership in a member organization 
of the World Confederation for Physical Therapy.
    (i) Standard: Physical therapist assistant. A person who is 
licensed, registered or certified as a physical therapist assistant, if 
applicable, by the state in which practicing, unless licensure does not 
apply and meets one of the following requirements:
    (1)(i) Graduated from a physical therapist assistant curriculum 
approved by the Commission on Accreditation in Physical Therapy 
Education of the American Physical Therapy Association; or if educated 
outside the United States or trained in the United States military, 
graduated from an education

[[Page 178]]

program determined to be substantially equivalent to physical therapist 
assistant entry level education in the United States by a credentials 
evaluation organization approved by the American Physical Therapy 
Association or identified at 8 CFR 212.15(e); and
    (ii) Passed a national examination for physical therapist 
assistants.
    (2) On or before December 31, 2009, meets one of the following:
    (i) Is licensed, or otherwise regulated in the state in which 
practicing.
    (ii) In states where licensure or other regulations do not apply, 
graduated before December 31, 2009, from a 2-year college-level program 
approved by the American Physical Therapy Association and after January 
1, 2010, meets the requirements of paragraph (h)(1) of this section.
    (3) Before January 1, 2008, where licensure or other regulation does 
not apply, graduated from a 2-year college level program approved by the 
American Physical Therapy Association.
    (4) On or before December 31, 1977, was licensed or qualified as a 
physical therapist assistant and has achieved a satisfactory grade on a 
proficiency examination conducted, approved, or sponsored by the U.S. 
Public Health Service.
    (j) Standard: Physician. A person who meets the qualifications and 
conditions specified in section 1861(r) of the Act and implemented at 
Sec. 410.20(b) of this chapter.
    (k) Standard: Registered nurse. A graduate of an approved school of 
professional nursing who is licensed in the state where practicing.
    (l) Standard: Social Work Assistant. A person who provides services 
under the supervision of a qualified social worker and:
    (1) Has a baccalaureate degree in social work, psychology, 
sociology, or other field related to social work, and has had at least 1 
year of social work experience in a health care setting; or
    (2) Has 2 years of appropriate experience as a social work 
assistant, and has achieved a satisfactory grade on a proficiency 
examination conducted, approved, or sponsored by the U.S. Public Health 
Service, except that the determinations of proficiency do not apply with 
respect to persons initially licensed by a state or seeking initial 
qualification as a social work assistant after December 31, 1977.
    (m) Standard: Social worker. A person who has a master's or doctoral 
degree from a school of social work accredited by the Council on Social 
Work Education, and has 1 year of social work experience in a health 
care setting.
    (n) Standard: Speech-language pathologist. A person who has a 
master's or doctoral degree in speech-language pathology, and who meets 
either of the following requirements:
    (1) Is licensed as a speech-language pathologist by the state in 
which the individual furnishes such services; or
    (2) In the case of an individual who furnishes services in a state 
which does not license speech-language pathologists:
    (i) Has successfully completed 350 clock hours of supervised 
clinical practicum (or is in the process of accumulating supervised 
clinical experience);
    (ii) Performed not less than 9 months of supervised full-time 
speech-language pathology services after obtaining a master's or 
doctoral degree in speech-language pathology or a related field; and
    (iii) Successfully completed a national examination in speech-
language pathology approved by the Secretary.

[82 FR 4578, Jan. 13, 2017, as amended at 82 FR 31732, July 10, 2017]

Subpart D [Reserved]



      Subpart E_Prospective Payment System for Home Health Agencies

    Source: 65 FR 41212, July 3, 2000, unless otherwise noted.



Sec. 484.200  Basis and scope.

    (a) Basis. This subpart implements section 1895 of the Act, which 
provides for the implementation of a prospective payment system (PPS) 
for HHAs for portions of cost reporting periods occurring on or after 
October 1, 2000.
    (b) Scope. This subpart sets forth the framework for the HHA PPS, 
including

[[Page 179]]

the methodology used for the development of the payment rates, 
associated adjustments, and related rules.



Sec. 484.202  Definitions.

    As used in this subpart--
    Case-mix index means a scale that measures the relative difference 
in resource intensity among different groups in the clinical model.
    Discipline means one of the six home health disciplines covered 
under the Medicare home health benefit (skilled nursing services, home 
health aide services, physical therapy services, occupational therapy 
services, speech- language pathology services, and medical social 
services).
    Furnishing Negative Pressure Wound Therapy (NPWT) using a disposable 
device means the application of a new applicable disposable device, as 
that term is defined in section 1834(s)(2) of the Act, which includes 
the professional services (specified by the assigned CPT[supreg] code) 
that are provided.
    HHCAHPS stands for Home Health Care Consumer Assessment of 
Healthcare Providers and Systems.
    HH QRP stands for Home Health Quality Reporting Program.
    Home health market basket index means an index that reflects changes 
over time in the prices of an appropriate mix of goods and services 
included in home health services.
    Rural area means an area defined in Sec. 412.64(b)(1)(ii)(C) of 
this chapter.
    Urban area means an area defined in Sec. 412.64(b)(1)(ii)(A) and 
(B) of this chapter.

[70 FR 68142, Nov. 9, 2005, as amended at 81 FR 76796, Nov. 3, 2016; 83 
FR 56628, Nov. 13, 2018; 84 FR 60644, Nov. 8, 2019]



Sec. 484.205  Basis of payment.

    (a) Method of payment. An HHA receives a national, standardized 
prospective payment amount for home health services previously paid on a 
reasonable cost basis (except the osteoporosis drug defined in section 
1861(kk) of the Act) as of August 5, 1997. The national, standardized 
prospective payment is determined in accordance with Sec. 484.215.
    (b) Unit of payment--(1) Episodes before December 31, 2019. For 
episodes beginning on or before December 31, 2019, an HHA receives a 
unit of payment equal to a national, standardized prospective 60-day 
episode payment amount.
    (2) Periods on or after January 1, 2020. For periods beginning on or 
after January 1, 2020, a HHA receives a unit of payment equal to a 
national, standardized prospective 30-day payment amount.
    (c) OASIS data. A HHA must submit to CMS the OASIS data described at 
Sec. 484.55(b) and (d) in order for CMS to administer the payment rate 
methodologies described in Sec. Sec. 484.215, 484.220, 484. 230, 
484.235, and 484.240.
    (d) Payment adjustments. The national, standardized prospective 
payment amount represents payment in full for all costs associated with 
furnishing home health services and is subject to the following 
adjustments and additional payments:
    (1) A low-utilization payment adjustment (LUPA) of a predetermined 
per-visit rate as specified in Sec. 484.230.
    (2) A partial payment adjustment as specified in Sec. 484.235.
    (3) An outlier payment as specified in Sec. 484.240.
    (e) Medical review. All payments under this system may be subject to 
a medical review adjustment reflecting the following:
    (1) Beneficiary eligibility.
    (2) Medical necessity determinations.
    (3) Case-mix group assignment.
    (f) Durable medical equipment (DME) and disposable devices. DME 
provided as a home health service as defined in section 1861(m) of the 
Act is paid the fee schedule amount. Separate payment is made for 
``furnishing NPWT using a disposable device,'' as that term is defined 
in Sec. 484.202, and is not included in the national, standardized 
prospective payment.
    (g) Split percentage payments. Normally, there are two payments 
(initial and final) paid for an HH PPS unit of payment. The initial 
payment is made in response to a request for anticipated payment (RAP) 
as described in paragraph (h) of this section, and the residual final 
payment is made in response to the submission of a final claim. Split 
percentage payments are made in accordance with requirements at Sec. 
409.43(c) of this chapter.

[[Page 180]]

    (1) Split percentage payments for episodes beginning on or before 
December 31, 2019--(i) Initial and residual final payments for initial 
episodes on or before December 31, 2019. (A) The initial payment for 
initial episodes is paid to an HHA at 60 percent of the case-mix and 
wage-adjusted 60-day episode rate.
    (B) The residual final payment for initial episodes is paid at 40 
percent of the case-mix and wage-adjusted 60-day episode rate.
    (ii) Initial and residual final payments for subsequent episodes 
before December 31, 2019. (A) The initial payment for subsequent 
episodes is paid to an HHA at 50 percent of the case-mix and wage-
adjusted 60-day episode rate.
    (B) The residual final payment for subsequent episodes is paid at 50 
percent of the case-mix and wage-adjusted 60-day episode rate.
    (2) Split percentage payments for periods beginning on or after 
January 1, 2020 through December 31, 2020--(i) HHAs certified for 
participation on or before December 31, 2018. (A) The initial payment 
for all 30-day periods is paid to an HHA at 20 percent of the case-mix 
and wage-adjusted 30-day payment rate.
    (B) The residual final payment for all 30-day periods is paid at 80 
percent of the case-mix and wage-adjusted 30-day payment rate.
    (ii) HHAs certified for participation in Medicare on or after 
January 1, 2019. Split percentage payments are not made to HHAs that are 
certified for participation in Medicare effective on or after January 1, 
2019. Newly enrolled HHAs must submit a request for anticipated payment, 
which is set at 0 percent, at the beginning of every 30-day period. An 
HHA that is certified for participation in Medicare effective on or 
after January 1, 2019 receives a single payment for a 30-day period of 
care after the final claim is submitted.
    (3) Split percentage payments for periods beginning on or after 
January 1, 2021 through December 31, 2021. All HHAs must submit a 
request for anticipated payment within 5 calendar days after the start 
of care date for initial 30-day periods and within 5 calendar days after 
the ``from date'' for each subsequent 30-day period of care, which is 
set at 0 percent at the beginning of every 30-day period. HHAs receive a 
single payment for a 30-day period of care after the final claim is 
submitted.
    (4) Payments for periods beginning on or after January 1, 2022. All 
HHAs must submit a Notice of Admission (NOA) at the beginning of the 
initial 30-day period of care as described in paragraph (j) of this 
section. HHAs receive a single payment for a 30-day period of care after 
the final claim is submitted.
    (h) Requests for anticipated payment (RAP) for 30-day periods of 
care starting on January 1, 2020 through December 31, 2020. (1) HHAs 
that are certified for participation in Medicare effective by December 
31, 2018 submit requests for anticipated payment (RAPs) to request the 
initial split percentage payment as specified in paragraph (g) of this 
section. HHAs that are certified for participation in Medicare effective 
on or after January 1, 2019 are still required to submit RAPs although 
no split percentage payments are made in response to these RAP 
submissions. The HHA can submit a RAP when all of the following 
conditions are met:
    (i) After the OASIS assessment required at Sec. 484.55(b)(1) and 
(d) is complete, locked or export ready, or there is an agency-wide 
internal policy establishing the OASIS data is finalized for 
transmission to the national assessment system.
    (ii) Once a physician or allowed practitioner's verbal orders for 
home care have been received and documented as required at Sec. Sec. 
484.60(b) and 409.43(d) of this chapter.
    (iii) A plan of care has been established and sent to the physician 
or allowed practitioner as required at Sec. 409.43(c) of this chapter.
    (iv) The first service visit under that plan has been delivered.
    (2) A RAP is based on the physician or allowed practitioner 
signature requirements in Sec. 409.43(c) of this chapter and is not a 
Medicare claim for purposes of the Act (although it is a ``claim'' for 
purposes of Federal, civil, criminal, and administrative law enforcement 
authorities, including but not limited to the following:
    (i) Civil Monetary Penalties Law (as defined in 42 U.S.C. 1320a-
7a(i)(2)).
    (ii) The Civil False Claims Act (as defined in 31 U.S.C. 3729(c)).

[[Page 181]]

    (iii) The Criminal False Claims Act (18 U.S.C. 287)).
    (iv) The RAP is canceled and recovered unless the claim is submitted 
within the greater of 60 days from the end date of the appropriate unit 
of payment, as defined in paragraph (b) of this section, or 60 days from 
the issuance of the RAP.
    (3) CMS has the authority to reduce, disprove, or cancel a RAP in 
situations when protecting Medicare program integrity warrants this 
action.
    (i) Submission of RAPs for CY 2021--(1) General. All HHAs must 
submit a RAP, which is to be paid at 0 percent, within 5 calendar days 
after the start of care and within 5 calendar days after the ``from 
date'' for each subsequent 30-day period of care.
    (2) Criteria for RAP submission for CY 2021. The HHA shall submit 
RAPs only when all of the following conditions are met:
    (i) Once physician or allowed practitioner's written or verbal 
orders that contain the services required for the initial visit have 
been received and documented as required at Sec. Sec. 484.60(b) and 
409.43(d) of this chapter.
    (ii) The initial visit within the 60-day certification period must 
have been made and the individual admitted to home health care.
    (3) Consequences of failure to submit a timely RAP. When a home 
health agency does not file the required RAP for its Medicare patients 
within 5 calendar days after the start of each 30-day period of care--
    (i) Medicare does not pay for those days of home health services 
based on the ``from date'' on the claim to the date of filing of the 
RAP;
    (ii) The wage and case-mix adjusted 30-day period payment amount is 
reduced by 1/30th for each day from the home health based on the ``from 
date'' on the claim until the date of filing of the RAP;
    (iii) No LUPA payments are made that fall within the late period;
    (iv) The payment reduction cannot exceed the total payment of the 
claim; and
    (v)(A) The non-covered days are a provider liability; and
    (B) The provider must not bill the beneficiary for the non-covered 
days.
    (4) Exception to the consequences for filing the RAP late. (i) CMS 
may waive the consequences of failure to submit a timely-filed RAP 
specified in paragraph (i)(3) of this section.
    (ii) CMS determines if a circumstance encountered by a home health 
agency is exceptional and qualifies for waiver of the consequence 
specified in paragraph (i)(3) of this section.
    (iii) A home health agency must fully document and furnish any 
requested documentation to CMS for a determination of exception. An 
exceptional circumstance may be due to, but is not limited to the 
following:
    (A) Fires, floods, earthquakes, or similar unusual events that 
inflict extensive damage to the home health agency's ability to operate.
    (B) A CMS or Medicare contractor systems issue that is beyond the 
control of the home health agency.
    (C) A newly Medicare-certified home health agency that is notified 
of that certification after the Medicare certification date, or which is 
awaiting its user ID from its Medicare contractor.
    (D) Other situations determined by CMS to be beyond the control of 
the home health agency.
    (j) Submission of Notice of Admission (NOA)--(1) For periods of care 
that begin on and after January 1, 2022. For all 30-day periods of care 
after January 1, 2022, all HHAs must submit a Notice of Admission (NOA) 
to their Medicare contractor within 5 calendar days after the start of 
care date. The NOA is a one-time submission to establish the home health 
period of care and covers contiguous 30-day periods of care until the 
individual is discharged from Medicare home health services.
    (2) Criteria for NOA submission. In order to submit the NOA, the 
following criteria must be met:
    (i) Once a physician or allowed practitioner's written or verbal 
orders that contains the services required for the initial visit have 
been received and documented as required at Sec. Sec. 484.60(b) and 
409.43(d) of this chapter.
    (ii) The initial visit must have been made and the individual 
admitted to home health care.
    (3) Consequences of failure to submit a timely Notice of Admission. 
When a home

[[Page 182]]

health agency does not file the required NOA for its Medicare patients 
within 5 calendar days after the start of care--
    (i) Medicare does not pay for those days of home health services 
from the start date to the date of filing of the notice of admission;
    (ii) The wage and case-mix adjusted 30-day period payment amount is 
reduced by 1/30th for each day from the home health start of care date 
until the date of filing of the NOA;
    (iii) No LUPA payments are made that fall within the late NOA 
period;
    (iv) The payment reduction cannot exceed the total payment of the 
claim; and
    (v)(A) The non-covered days are a provider liability; and
    (B) The provider must not bill the beneficiary for the non-covered 
days.
    (4) Exception to the consequences for filing the NOA late. (i) CMS 
may waive the consequences of failure to submit a timely-filed NOA 
specified in paragraph (j)(3) of this section.
    (ii) CMS determines if a circumstance encountered by a home health 
agency is exceptional and qualifies for waiver of the consequence 
specified in paragraph (j)(3) of this section.
    (iii) A home health agency must fully document and furnish any 
requested documentation to CMS for a determination of exception. An 
exceptional circumstance may be due to, but is not limited to the 
following:
    (A) Fires, floods, earthquakes, or similar unusual events that 
inflict extensive damage to the home health agency's ability to operate.
    (B) A CMS or Medicare contractor systems issue that is beyond the 
control of the home health agency.
    (C) A newly Medicare-certified home health agency that is notified 
of that certification after the Medicare certification date, or which is 
awaiting its user ID from its Medicare contractor.
    (D) Other situations determined by CMS to be beyond the control of 
the home health agency.

[83 FR 56628, Nov. 13, 2018, as amended at 84 FR 60644, Nov. 8, 2019; 85 
FR 27628, May 8, 2020]



Sec. 484.215  Initial establishment of the calculation of the
national, standardized prospective payment rates.

    (a) Determining an HHA's costs. In calculating the initial 
unadjusted national 60-day episode payment applicable for a service 
furnished by an HHA using data on the most recent available audited cost 
reports, CMS determines each HHA's costs by summing its allowable costs 
for the period. CMS determines the national mean cost per visit.
    (b) Determining HHA utilization. In calculating the initial 
unadjusted national 60-day episode payment, CMS determines the national 
mean utilization for each of the six disciplines using home health 
claims data.
    (c) Use of the market basket index. CMS uses the HHA market basket 
index to adjust the HHA cost data to reflect cost increases occurring 
between October 1, 1996 through September 30, 2001.
    (d) Calculation of the unadjusted national average prospective 
payment amount for the 60-day episode. For episodes beginning on or 
before December 31, 2019, CMS calculates the unadjusted national 60-day 
episode payment in the following manner:
    (1) By computing the mean national cost per visit.
    (2) By computing the national mean utilization for each discipline.
    (3) By multiplying the mean national cost per visit by the national 
mean utilization summed in the aggregate for the six disciplines.
    (4) By adding to the amount derived in paragraph (d)(3) of this 
section, amounts for nonroutine medical supplies, an OASIS adjustment 
for estimated ongoing reporting costs, an OASIS adjustment for the one 
time implementation costs associated with assessment scheduling form 
changes and amounts for Part B therapies that could have been unbundled 
to Part B prior to October 1, 2000. The resulting amount is the 
unadjusted national 60-day episode rate.
    (e) Standardization of the data for variation in area wage levels 
and case-mix. CMS standardizes--
    (1) The cost data described in paragraph (a) of this section to 
remove the effects of geographic variation in wage levels and variation 
in case-mix;

[[Page 183]]

    (2) The cost data for geographic variation in wage levels using the 
hospital wage index; and
    (3) The cost data for HHA variation in case-mix using the case-mix 
indices and other data that indicate HHA case-mix.
    (f) For periods beginning on or after January 1, 2020, a national, 
standardized prospective 30-day payment rate applies. The national, 
standardized prospective 30-day payment rate is an amount determined by 
the Secretary, as subsequently adjusted in accordance with Sec. 
484.225.

[65 FR 41212, July 3, 2000, as amended at 83 FR 56629, Nov. 13, 2018]



Sec. 484.220  Calculation of the case-mix and wage area adjusted 
prospective payment rates.

    CMS adjusts the national, standardized prospective payment rates as 
referenced in Sec. 484.215 to account for the following:
    (a) HHA case-mix using a case-mix index to explain the relative 
resource utilization of different patients. To address changes to the 
case-mix that are a result of changes in the coding or classification of 
different units of service that do not reflect real changes in case-mix, 
the national, standardized prospective payment rate will be adjusted 
downward as follows:
    (1) For CY 2008, the adjustment is 2.75 percent.
    (2) For CY 2009 and CY 2010, the adjustment is 2.75 percent in each 
year.
    (3) For CY 2011, the adjustment is 3.79 percent.
    (4) For CY 2012, the adjustment is 3.79 percent.
    (5) For CY 2013, the adjustment is 1.32 percent.
    (6) For CY 2016, CY 2017, and CY 2018, the adjustment is 0.97 
percent in each year.
    (b) Geographic differences in wage levels using an appropriate wage 
index based on the site of service of the beneficiary.

[72 FR 49879, Aug. 29, 2007, as amended at 80 FR 68717, Nov. 5, 2015; 83 
FR 56629, Nov. 13, 2018]



Sec. 484.225  Annual update of the unadjusted national, standardized
prospective payment rates.

    (a) CMS annually updates the unadjusted national, standardized 
prospective payment rate on a calendar year basis (in accordance with 
section 1895(b)(1)(B) of the Act).
    (b) For 2007 and subsequent calendar years, in accordance with 
section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency 
that does not submit home health quality data, as specified by the 
Secretary, the unadjusted national, standardized prospective rate is 
equal to the rate for the previous calendar year increased by the 
applicable home health market basket index amount minus 2 percentage 
points. Any reduction of the percentage change will apply only to the 
calendar year involved and will not be taken into account in computing 
the prospective payment amount for a subsequent calendar year.
    (c) For CY 2020, the national, standardized prospective 30-day 
payment amount is an amount determined by the Secretary. CMS annually 
updates this amount on a calendar year basis in accordance with 
paragraphs (a) and (b) of this section.

[80 FR 68717, Nov. 5, 2015, as amended at 83 FR 56629, Nov. 13, 2018; 84 
FR 60645, Nov. 8, 2019]



Sec. [thinsp]484.230  Low-utilization payment adjustments.

    (a) For episodes beginning on or before December 31, 2019, an 
episode with four or fewer visits is paid the national per-visit amount 
by discipline determined in accordance with Sec. 484.215(a) and updated 
annually by the applicable market basket for each visit type, in 
accordance with Sec. 484.225.
    (1) The national per-visit amount is adjusted by the appropriate 
wage index based on the site of service of the beneficiary.
    (2) An amount is added to the low-utilization payment adjustments 
for low-utilization episodes that occur as the beneficiary's only 
episode or initial episode in a sequence of adjacent episodes.
    (3) For purposes of the home health PPS, a sequence of adjacent 
episodes for a beneficiary is a series of claims

[[Page 184]]

with no more than 60 days without home care between the end of one 
episode, which is the 60th day (except for episodes that have been PEP-
adjusted), and the beginning of the next episode.
    (b) For periods beginning on or after January 1, 2020, an HHA 
receives a national 30-day payment of a predetermined rate for home 
health services, unless CMS determines at the end of the 30-day period 
that the HHA furnished minimal services to a patient during the 30-day 
period.
    (1) For each payment group used to case-mix adjust the 30-day 
payment rate, the 10th percentile value of total visits during a 30-day 
period of care is used to create payment group specific thresholds with 
a minimum threshold of at least 2 visits for each case-mix group.
    (2) A 30-day period with a total number of visits less than the 
threshold is paid the national per-visit amount by discipline determined 
in accordance with Sec. 484.215(a) and updated annually by the 
applicable market basket for each visit type, in accordance with Sec. 
484.225.
    (3) The national per-visit amount is adjusted by the appropriate 
wage index based on the site of service for the beneficiary.
    (c) An amount is added to low-utilization payment adjustments for 
low-utilization periods that occur as the beneficiary's only 30-day 
period or initial 30-day period in a sequence of adjacent periods of 
care. For purposes of the home health PPS, a sequence of adjacent 
periods of care for a beneficiary is a series of claims with no more 
than 60 days without home care between the end of one period, which is 
the 30th day (except for episodes that have been partial payment 
adjusted), and the beginning of the next episode.

[83 FR 56629, Nov. 13, 2018]



Sec. 484.235  Partial payment adjustments.

    (a) Partial episode payments (PEPs) for episodes beginning on or 
before December 31, 2019. (1) An HHA receives a national, standardized 
60-day payment of a predetermined rate for home health services unless 
CMS determines an intervening event, defined as a beneficiary elected 
transfer or discharge with goals met or no expectation of return to home 
health and the beneficiary returned to home health during the 60-day 
episode, warrants a new 60-day episode for purposes of payment. A start 
of care OASIS assessment and physician or allowed practitioner 
certification of the new plan of care are required.
    (2) The PEP adjustment does not apply in situations of transfers 
among HHAs of common ownership.
    (i) Those situations are considered services provided under 
arrangement on behalf of the originating HHA by the receiving HHA with 
the common ownership interest for the balance of the 60-day episode.
    (ii) The common ownership exception to the transfer PEP adjustment 
does not apply if the beneficiary moves to a different MSA or Non-MSA 
during the 60-day episode before the transfer to the receiving HHA.
    (iii) The transferring HHA in situations of common ownership not 
only serves as a billing agent, but must also exercise professional 
responsibility over the arranged-for services in order for services 
provided under arrangements to be paid.
    (3) If the intervening event warrants a new 60-day payment and a new 
physician or allowed practitioner certification and a new plan of care, 
the initial HHA receives a partial episode payment adjustment reflecting 
the length of time the patient remained under its care based on the 
first billable visit date through and including the last billable visit 
date. The PEP is calculated by determining the actual days served as a 
proportion of 60 multiplied by the initial 60-day payment amount.
    (b) Partial payment adjustments for periods beginning on or after 
January 1, 2020. (1) An HHA receives a national, standardized 30-day 
payment of a predetermined rate for home health services unless CMS 
determines an intervening event, defined as a beneficiary elected 
transfer or discharge with goals met or no expectation of return to home 
health and the beneficiary returned to home health during the 30-day 
period, warrants a new 30-day period for purposes of payment. A start of

[[Page 185]]

care OASIS assessment and certification of the new plan of care are 
required.
    (2) The partial payment adjustment does not apply in situations of 
transfers among HHAs of common ownership.
    (i) Those situations are considered services provided under 
arrangement on behalf of the originating HHA by the receiving HHA with 
the common ownership interest for the balance of the 30-day period.
    (ii) The common ownership exception to the transfer partial payment 
adjustment does not apply if the beneficiary moves to a different MSA or 
Non-MSA during the 30-day period before the transfer to the receiving 
HHA.
    (iii) The transferring HHA in situations of common ownership not 
only serves as a billing agent, but must also exercise professional 
responsibility over the arranged-for services in order for services 
provided under arrangements to be paid.
    (3) If the intervening event warrants a new 30-day payment and a new 
physician or allowed practitioner certification and a new plan of care, 
the initial HHA receives a partial payment adjustment reflecting the 
length of time the patient remained under its care based on the first 
billable visit date through and including the last billable visit date. 
The partial payment is calculated by determining the actual days served 
as a proportion of 30 multiplied by the initial 30-day payment amount.

[83 FR 56629, Nov. 13, 2018, as amended at 85 FR 27628, May 8, 2020]



Sec. [thinsp]484.240  Outlier payments.

    (a) For episodes beginning on or before December 31, 2019, an HHA 
receives an outlier payment for an episode whose estimated costs exceeds 
a threshold amount for each case-mix group. The outlier threshold for 
each case-mix group is the episode payment amount for that group, or the 
PEP adjustment amount for the episode, plus a fixed dollar loss amount 
that is the same for all case-mix groups.
    (b) For periods beginning on or after January 1, 2020, an HHA 
receives an outlier payment for a 30-day period whose estimated cost 
exceeds a threshold amount for each case-mix group. The outlier 
threshold for each case-mix group is the 30-day payment amount for that 
group, or the partial payment adjustment amount for the 30-day period, 
plus a fixed dollar loss amount that is the same for all case-mix 
groups.
    (c) The outlier payment is a proportion of the amount of imputed 
cost beyond the threshold.
    (d) CMS imputes the cost for each claim by multiplying the national 
per-15 minute unit amount of each discipline by the number of 15 minute 
units in the discipline and computing the total imputed cost for all 
disciplines.

[83 FR 56630, Nov. 13, 2018]



Sec. 484.245  Requirements under the Home Health Quality Reporting 
Program (HH QRP).

    (a) Participation. Beginning January 1, 2007, an HHA must report 
Home Health Quality Reporting Program (HH QRP) data in accordance with 
the requirements of this section.
    (b) Data submission. (1) Except as provided in paragraph (d) of this 
section, and for a program year, an HHA must submit all of the following 
to CMS:
    (i) Data on measures specified under sections 1899B(c)(1) and 
1899B(d)(1) of the Act.
    (ii) Standardized patient assessment data required under section 
1899B(b)(1) of the Act.
    (iii) Quality data required under section 1895(b)(3)(B)(v)(II) of 
the Act, including HHCAHPS survey data. For purposes of HHCAHPS survey 
data submission, the following additional requirements apply:
    (A) Patient count. An HHA that has less than 60 eligible unique 
HHCAHPS patients must annually submit to CMS their total HHCAHPS patient 
count to CMS to be exempt from the HHCAHPS reporting requirements for a 
calendar year.
    (B) Survey requirements. An HHA must contract with an approved, 
independent HHCAHPS survey vendor to administer the HHCAHPS on its 
behalf.

[[Page 186]]

    (C) CMS approval. CMS approves an HHCAHPS survey vendor if the 
applicant has been in business for a minimum of 3 years and has 
conducted surveys of individuals and samples for at least 2 years.
    (1) For HHCAHPS, a ``survey of individuals'' is defined as the 
collection of data from at least 600 individuals selected by statistical 
sampling methods and the data collected are used for statistical 
purposes.
    (2) All applicants that meet the requirements in this paragraph 
(b)(1)(iii)(C) are approved by CMS.
    (D) Disapproval by CMS. No organization, firm, or business that 
owns, operates, or provides staffing for an HHA is permitted to 
administer its own HHCAHPS Survey or administer the survey on behalf of 
any other HHA in the capacity as an HHCAHPS survey vendor. Such 
organizations are not be approved by CMS as HHCAHPS survey vendors.
    (E) Compliance with oversight activities. Approved HHCAHPS survey 
vendors must fully comply with all HHCAHPS oversight activities, 
including allowing CMS and its HHCAHPS program team to perform site 
visits at the vendors' company locations.
    (2) The data submitted under paragraph (b) of this section must be 
submitted in the form and manner, and at a time, specified by CMS.
    (c) Exceptions and extension requirements. (1) An HHA may request 
and CMS may grant exceptions or extensions to the reporting requirements 
under paragraph (b) of this section for one or more quarters, when there 
are certain extraordinary circumstances beyond the control of the HHA.
    (2) An HHA may request an exception or extension within 90 days of 
the date that the extraordinary circumstances occurred by sending an 
email to CMS HHAPU reconsiderations at [email protected] 
that contains all of the following information:
    (i) HHA CMS Certification Number (CCN).
    (ii) HHA Business Name.
    (iii) HHA Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, title, telephone number, email address, and mailing address (the 
address must be a physical address, not a post office box).
    (v) HHA's reason for requesting the exception or extension.
    (vi) Evidence of the impact of extraordinary circumstances, 
including, but not limited to, photographs, newspaper, and other media 
articles.
    (vii) Date when the HHA believes it will be able to again submit 
data under paragraph (b) of this section and a justification for the 
proposed date.
    (3) Except as provided in paragraph (c)(4) of this section, CMS does 
not consider an exception or extension request unless the HHA requesting 
such exception or extension has complied fully with the requirements in 
this paragraph (c).
    (4) CMS may grant exceptions or extensions to HHAs without a request 
if it determines that one or more of the following has occurred:
    (i) An extraordinary circumstance, such as an act of nature, affects 
an entire region or locale.
    (ii) A systemic problem with one of CMS's data collection systems 
directly affects the ability of an HHA to submit data under paragraph 
(b) of this section.
    (d) Reconsiderations. (1)(i) HHAs that do not meet the quality 
reporting requirements under this section for a program year will 
receive a letter of noncompliance via the United States Postal Service 
and the CMS-designated data submission system.
    (ii) An HHA may request reconsideration no later than 30 calendar 
days after the date identified on the letter of non-compliance.
    (2) Reconsideration requests may be submitted to CMS by sending an 
email to CMS HHAPU reconsiderations at [email protected] 
containing all of the following information:
    (i) HHA CCN.
    (ii) HHA Business Name.
    (iii) HHA Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, title, telephone number, email address, and mailing address (the 
address must be a physical address, not a post office box).

[[Page 187]]

    (v) CMS identified reason(s) for non-compliance as stated in the 
non-compliance letter.
    (vi) Reason(s) for requesting reconsideration, including all 
supporting documentation.
    (3) CMS does not consider a reconsideration request unless the HHA 
has complied fully with the submission requirements in paragraphs (d)(1) 
and (2) of this section.
    (4) CMS makes a decision on the request for reconsideration and 
provide notice of the decision to the HHA via letter sent via the United 
States Postal Service.
    (e) Appeals. An HHA that is dissatisfied with CMS' decision on a 
request for reconsideration submitted under paragraph (d) of this 
section may file an appeal with the Provider Reimbursement Review Board 
(PRRB) under 42 CFR part 405, subpart R.

[84 FR 60645, Nov. 8, 2019]



Sec. 484.250  OASIS data.

    An HHA must submit to CMS the OASIS data described at Sec. 
484.55(b) and (d) as is necessary for CMS to administer the payment rate 
methodologies described in Sec. Sec. 484.215, 484.220, 484.230, 
484.235, and 484.240.

[84 FR 60646, Nov. 8, 2019]



Sec. 484.260  Limitation on review.

    An HHA is not entitled to judicial or administrative review under 
sections 1869 or 1878 of the Act, or otherwise, with regard to the 
establishment of the payment unit, including the national 60-day 
prospective episode payment rate, adjustments and outlier payments. An 
HHA is not entitled to the review regarding the establishment of the 
transition period, definition and application of the unit of payments, 
the computation of initial standard prospective payment amounts, the 
establishment of the adjustment for outliers, and the establishment of 
case-mix and area wage adjustment factors.



Sec. 484.265  Additional payment.

    An additional payment is made to a home health agency in accordance 
with Sec. 476.78 of this chapter for the costs of sending requested 
patient records to the QIO in electronic format, by facsimile, or by 
photocopying and mailing.

[85 FR 59026, Sept. 18, 2020]



 Subpart F_Home Health Value-Based Purchasing (HHVBP) Model Components 
       for Competing Home Health Agencies Within State Boundaries

    Source: 80 FR 68718, Nov. 5, 2015, unless otherwise noted.



Sec. 484.300  Basis and scope of subpart.

    This subpart is established under sections 1102, 1115A, and 1871 of 
the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue 
regulations to operate the Medicare program and test innovative payment 
and service delivery models to improve coordination, quality, and 
efficiency of health care services furnished under Title XVIII.



Sec. 484.305  Definitions.

    As used in this subpart--
    Applicable measure means a measure for which a competing HHA has 
provided a minimum of--
    (1) Twenty home health episodes of care per year for the OASIS-based 
measures;
    (2) Twenty home health episodes of care per year for the claims-
based measures; or
    (3) Forty completed surveys for the HHCAHPS measures.
    Applicable percent means a maximum upward or downward adjustment for 
a given performance year, not to exceed the following:
    (1) For CY 2018, 3-percent.
    (2) For CY 2019, 5-percent.
    (3) For CY 2020, 6-percent.
    (4) For CY 2021, 7-percent.
    (5) For CY 2022, 8-percent.
    Benchmark refers to the mean of the top decile of Medicare-certified 
HHA performance on the specified quality measure during the baseline 
period, calculated for each state.
    Competing home health agency or agencies means an agency or 
agencies:
    (1) That has or have a current Medicare certification; and,
    (2) Is or are being paid by CMS for home health care delivered 
within any of the states specified in Sec. 484.310.

[[Page 188]]

    Home health prospective payment system (HH PPS) refers to the basis 
of payment for home health agencies as set forth in Sec. Sec. 484.200 
through 484.245.
    Larger-volume cohort means the group of competing home health 
agencies within the boundaries of selected states that are participating 
in HHCAHPs in accordance with Sec. 484.250.
    Linear exchange function is the means to translate a competing HHA's 
Total Performance Score into a value-based payment adjustment 
percentage.
    New measures means those measures to be reported by competing HHAs 
under the HHVBP Model that are not otherwise reported by Medicare-
certified HHAs to CMS and were identified to fill gaps to cover National 
Quality Strategy Domains not completely covered by existing measures in 
the home health setting.
    Payment adjustment means the amount by which a competing HHA's final 
claim payment amount under the HH PPS is changed in accordance with the 
methodology described in Sec. 484.325.
    Performance period means the time period during which data are 
collected for the purpose of calculating a competing HHA's performance 
on measures.
    Selected state(s) means those nine states that were randomly 
selected to compete/participate in the HHVBP Model via a computer 
algorithm designed for random selection and identified at Sec. 
484.310(b).
    Smaller-volume cohort means the group of competing home health 
agencies within the boundaries of selected states that are exempt from 
participation in HHCAHPs in accordance with Sec. 484.250.
    Total Performance Score means the numeric score ranging from 0 to 
100 awarded to each competing HHA based on its performance under the 
HHVBP Model.
    Value-based purchasing means measuring, reporting, and rewarding 
excellence in health care delivery that takes into consideration 
quality, efficiency, and alignment of incentives. Effective health care 
services and high performing health care providers may be rewarded with 
improved reputations through public reporting, enhanced payments through 
differential reimbursements, and increased market share through 
purchaser, payer, and/or consumer selection.

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 82 
FR 51752, Nov. 7, 2017]



Sec. 484.310  Applicability of the Home Health Value-Based Purchasing
(HHVBP) Model.

    (a) General rule. The HHVBP Model applies to all Medicare-certified 
home health agencies (HHAs) in selected states.
    (b) Selected states. Nine states have been selected in accordance 
with CMS's selection methodology. All Medicare-certified HHAs that 
provide services in Massachusetts, Maryland, North Carolina, Florida, 
Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to 
compete in this model.



Sec. 484.315  Data reporting for measures and evaluation and the public
reporting of model data under the Home Health Value-Based Purchasing 
(HHVBP) Model.

    (a) Competing home health agencies will be evaluated using a set of 
quality measures.
    (b) Competing home health agencies in selected states will be 
required to report information on New Measures, as determined 
appropriate by the Secretary, to CMS in the form, manner, and at a time 
specified by the Secretary, and subject to any exceptions or extensions 
CMS may grant to home health agencies for the Public Health Emergency as 
defined in Sec. 400.200 of this chapter.
    (c) Competing home health agencies in selected states will be 
required to collect and report such information as the Secretary 
determines is necessary for purposes of monitoring and evaluating the 
HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
    (d) For performance year 5, CMS publicly reports the following for 
each competing home health agency on the CMS website:
    (1) The Total Performance Score.
    (2) The percentile ranking of the Total Performance Score.

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 84 
FR 60646, Nov. 8, 2019; 85 FR 27628, May 8, 2020]

[[Page 189]]



Sec. 484.320  Calculation of the Total Performance Score.

    A competing home health agency's Total Performance Score for a model 
year is calculated as follows:
    (a) CMS will award points to the competing home health agency for 
performance on each of the applicable measures excluding the New 
Measures.
    (b) CMS will award points to the competing home health agency for 
reporting on each of the New Measures worth up to ten percent of the 
Total Performance Score.
    (c)(1) For performance years 1 through 3, CMS will sum all points 
awarded for each applicable measure excluding the New Measures, weighted 
equally at the individual measure level to calculate a value worth 90 
percent of the Total Performance Score.
    (2) For performance years 4 and 5, CMS will sum all points awarded 
for each applicable measure within each category of measures (OASIS-
based, claims-based and HHCAHPS) excluding the New Measures, weighted at 
35 percent for the OASIS-based measure category, 35 percent for the 
claims-based measure category, and 30 percent for the HHCAHPS measure 
category when all three measure categories are reported, to calculate a 
value worth 90 percent of the Total Performance Score.
    (d) The sum of the points awarded to a competing HHA for each 
applicable measure and the points awarded to a competing HHA for 
reporting data on each New Measure is the competing HHA's Total 
Performance Score for the calendar year.

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 83 
FR 56630, Nov. 13, 2018]



Sec. 484.325  Payments for home health services under Home Health
Value-Based Purchasing (HHVBP) Model.

    CMS will determine a payment adjustment up to the maximum applicable 
percentage, upward or downward, under the HHVBP Model for each competing 
home health agency based on the agency's Total Performance Score using a 
linear exchange function. Payment adjustments made under the HHVBP Model 
will be calculated as a percentage of otherwise-applicable payments for 
home health services provided under section 1895 of the Act (42 U.S.C. 
1395fff).



Sec. 484.330  Process for determining and applying the value-based
payment adjustment under the Home Health Value-Based Purchasing 
(HHVBP) Model.

    (a) General. Competing home health agencies will be ranked within 
the larger-volume and smaller-volume cohorts in selected states based on 
the performance standards that apply to the HHVBP Model for the baseline 
year, and CMS will make value-based payment adjustments to the competing 
HHAs as specified in this section.
    (b) Calculation of the value-based payment adjustment amount. The 
value-based payment adjustment amount is calculated by multiplying the 
Home Health Prospective Payment final claim payment amount as calculated 
in accordance with Sec. 484.205 by the payment adjustment percentage.
    (c) Calculation of the payment adjustment percentage. The payment 
adjustment percentage is calculated as the product of: The applicable 
percent as defined in Sec. 484.320, the competing HHA's Total 
Performance Score divided by 100, and the linear exchange function 
slope.



Sec. 484.335  Appeals process for the Home Health Value-Based
Purchasing (HHVBP) Model.

    (a) Requests for recalculation--(1) Matters for recalculation. 
Subject to the limitations on review under section 1115A of the Act, a 
HHA may submit a request for recalculation under this section if it 
wishes to dispute the calculation of the following:
    (i) Interim performance scores.
    (ii) Annual total performance scores.
    (iii) Application of the formula to calculate annual payment 
adjustment percentages.
    (2) Time for filing a request for recalculation. A recalculation 
request must be submitted in writing within 15 calendar days after CMS 
posts the HHA-specific information on the HHVBP Secure Portal, in a time 
and manner specified by CMS.
    (3) Content of request. (i) The provider's name, address associated 
with

[[Page 190]]

the services delivered, and CMS Certification Number (CCN).
    (ii) The basis for requesting recalculation to include the specific 
quality measure data that the HHA believes is inaccurate or the 
calculation the HHA believes is incorrect.
    (iii) Contact information for a person at the HHA with whom CMS or 
its agent can communicate about this request, including name, email 
address, telephone number, and mailing address (must include physical 
address, not just a post office box).
    (iv) The HHA may include in the request for recalculation additional 
documentary evidence that CMS should consider. Such documents may not 
include data that was to have been filed by the applicable data 
submission deadline, but may include evidence of timely submission.
    (4) Scope of review for recalculation. In conducting the 
recalculation, CMS will review the applicable measures and performance 
scores, the evidence and findings upon which the determination was 
based, and any additional documentary evidence submitted by the home 
health agency. CMS may also review any other evidence it believes to be 
relevant to the recalculation.
    (5) Recalculation decision. CMS will issue a written notification of 
findings. A recalculation decision is subject to the request for 
reconsideration process in accordance with paragraph (b) of this 
section.
    (b) Requests for reconsideration--(1) Matters for reconsideration. A 
home health agency may request reconsideration of the recalculation of 
its annual total performance score and payment adjustment percentage 
following a decision on the home health agency's recalculation request 
submitted under paragraph (a) of this section, or the decision to deny 
the recalculation request submitted under paragraph (a) of this section.
    (2) Time for filing a request for reconsideration. The request for 
reconsideration must be submitted via the HHVBP Secure Portal within 15 
calendar days from CMS' notification to the HHA contact of the outcome 
of the recalculation process.
    (3) Content of request. (i) The name of the HHA, address associated 
with the services delivered, and CMS Certification Number (CCN).
    (ii) The basis for requesting reconsideration to include the 
specific quality measure data that the HHA believes is inaccurate or the 
calculation the HHA believes is incorrect.
    (iii) Contact information for a person at the HHA with whom CMS or 
its agent can communicate about this request, including name, email 
address, telephone number, and mailing address (must include physical 
address, not just a post office box).
    (iv) The HHA may include in the request for reconsideration 
additional documentary evidence that CMS should consider. Such documents 
may not include data that was to have been filed by the applicable data 
submission deadline, but may include evidence of timely submission.
    (4) Scope of review for reconsideration. In conducting the 
reconsideration review, CMS will review the applicable measures and 
performance scores, the evidence and findings upon which the 
determination was based, and any additional documentary evidence 
submitted by the HHA. CMS may also review any other evidence it believes 
to be relevant to the reconsideration. The HHA must prove its case by a 
preponderance of the evidence with respect to issues of fact.
    (5) Reconsideration decision. CMS reconsideration officials will 
issue a written determination.

[81 FR 76796, Nov. 3, 2016]



PART 485_CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--
Table of Contents



Subpart A [Reserved]

    Subpart B_Conditions of Participation: Comprehensive Outpatient 
                        Rehabilitation Facilities

Sec.
485.50 Basis and scope.
485.51 Definition.
485.54 Condition of participation: Compliance with State and local laws.
485.56 Condition of participation: Governing body and administration.
485.58 Condition of participation: Comprehensive rehabilitation program.

[[Page 191]]

485.60 Condition of participation: Clinical records.
485.62 Condition of participation: Physical environment.
485.64 [Reserved]
485.66 Condition of participation: Utilization review plan.
485.68 Condition of participation: Emergency preparedness.
485.70 Personnel qualifications.
485.74 Appeal rights.

Subparts C-E [Reserved]

 Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)

485.601 Basis and scope.
485.603 Rural health network.
485.604 Personnel qualifications.
485.606 Designation and certification of CAHs.
485.608 Condition of participation: Compliance with Federal, State, and 
          local laws and regulations.
485.610 Condition of participation: Status and location.
485.612 Condition of participation: Compliance with hospital 
          requirements at the time of application.
485.616 Condition of participation: Agreements.
485.618 Condition of participation: Emergency services.
485.620 Condition of participation: Number of beds and length of stay.
485.623 Condition of participation: Physical plant and environment.
485.625 Condition of participation: Emergency preparedness.
485.627 Condition of participation: Organizational structure.
485.631 Condition of participation: Staffing and staff responsibilities.
485.635 Condition of participation: Provision of services.
485.638 Condition of participation: Clinical records.
485.639 Condition of participation: Surgical services.
485.640 Condition of participation: Infection prevention and control and 
          antibiotic stewardship programs.
485.641 Condition of participation: Quality assessment and performance 
          improvement program.
485.642 Condition of participation: Discharge planning.
485.643 Condition of participation: Organ, tissue, and eye procurement.
485.645 Special requirements for CAH providers of long-term care 
          services (``swing-beds'').
485.647 Condition of participation: psychiatric and rehabilitation 
          distinct part units.

Subpart G [Reserved]

   Subpart H_Conditions of Participation for Clinics, Rehabilitation 
Agencies, and Public Health Agencies as Providers of Outpatient Physical 
             Therapy and Speech-Language Pathology Services

485.701 Basis and scope.
485.703 Definitions.
485.705 Personnel qualifications.
485.707 Condition of participation: Compliance with Federal, State, and 
          local laws.
485.709 Condition of participation: Administrative management.
485.711 Condition of participation: Plan of care and physician 
          involvement.
485.713 Condition of participation: Physical therapy services.
485.715 Condition of participation: Speech pathology services.
485.717 Condition of participation: Rehabilitation program.
485.719 Condition of participation: Arrangements for physical therapy 
          and speech pathology services to be performed by other than 
          salaried organization personnel.
485.721 Condition of participation: Clinical records.
485.723 Condition of participation: Physical environment.
485.725 Condition of participation: Infection control.
485.727 Condition of participation: Emergency preparedness.
485.729 Condition of participation: Program evaluation.

Subpart I [Reserved]

 Subpart J_Conditions of Participation: Community Mental Health Centers 
                                 (CMHCs)

485.900 Basis and scope.
485.902 Definitions.
485.904 Condition of participation: Personnel qualifications.
485.910 Condition of participation: Client rights.
485.914 Condition of participation: Admission, initial evaluation, 
          comprehensive assessment, and discharge or transfer of the 
          client.
485.916 Condition of participation: Treatment team, person-centered 
          active treatment plan, and coordination of services.
485.917 Condition of participation: Quality assessment and performance 
          improvement.
485.918 Condition of participation: Organization, governance, 
          administration of services, and partial hospitalization 
          services.
485.920 Condition of participation: Emergency preparedness.


[[Page 192]]


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

    Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. 
Redesignated at 50 FR 33034, Aug. 16, 1985.

Subpart A [Reserved]



    Subpart B_Conditions of Participation: Comprehensive Outpatient 
                        Rehabilitation Facilities



Sec. 485.50  Basis and scope.

    This subpart sets forth the conditions that facilities must meet to 
be certified as comprehensive outpatient rehabilitation facilities 
(CORFs) under section 1861(cc)(2) of the Social Security Act and be 
accepted for participation in Medicare in accordance with part 489 of 
this chapter.



Sec. 485.51  Definition.

    As used in this subpart, unless the context indicates otherwise, 
``comprehensive outpatient rehabilitation facility'', ``CORF'', or 
``facility'' means a nonresidential facility that--
    (a) Is established and operated exclusively for the purpose of 
providing diagnostic, therapeutic, and restorative services to 
outpatients for the rehabilitation of injured, disabled, or sick 
persons, at a single fixed location, by or under the supervision of a 
physician except as provided in paragraph (c) of this section;
    (b) Meets all the requirements of this subpart.
    (c) Exception. May provide influenza, pneumococcal and Hepatitis B 
vaccines provided the applicable conditions of coverage under Sec. 
410.58 and Sec. 410.63 of this chapter are met.

[48 FR 56293, Dec. 15, 1982, as amended at 72 FR 66408, Nov. 27, 2007]



Sec. 485.54  Condition of participation: Compliance with State 
and local laws.

    The facility and all personnel who provide services must be in 
compliance with applicable State and local laws and regulations.
    (a) Standard: Licensure of facility. If State or local law provides 
for licensing, the facility must be currently licensed or approved as 
meeting the standards established for licensure.
    (b) Standard: Licensure of personnel. Personnel that provide service 
must be licensed, certified, or registered in accordance with applicable 
State and local laws.



Sec. 485.56  Condition of participation: Governing body and 
administration.

    The facility must have a governing body that assumes full legal 
responsibility for establishing and implementing policies regarding the 
management and operation of the facility.
    (a) Standard: Disclosure of ownership. The facility must comply with 
the provisions of part 420, subpart C of this chapter that require 
health care providers and fiscal agents to disclose certain information 
about ownership and control.
    (b) Standard: Administrator. The governing body must appoint an 
administrator who--
    (1) Is responsible for the overall management of the facility under 
the authority delegated by the governing body;
    (2) Implements and enforces the facility's policies and procedures;
    (3) Designates, in writing, an individual who, in the absence of the 
administrator, acts on behalf of the administrator; and
    (4) Retains professional and administrative responsibility for all 
personnel providing facility services.
    (c) Standard: Group of professional personnel. The facility must 
have a group of professional personnel associated with the facility 
that--
    (1) Develops and periodically reviews policies to govern the 
services provided by the facility; and
    (2) Consists of at least one physician and one professional 
representing each of the services provided by the facility.
    (d) Standard: Institutional budget plan. The facility must have an 
institutional budget plan that meets the following conditions:
    (1) It is prepared, under the direction of the governing body, by a 
committee consisting of representatives of the governing body and the 
administrative staff.
    (2) It provides for--

[[Page 193]]

    (i) An annual operating budget prepared according to generally 
accepted accounting principles;
    (ii) A 3-year capital expenditure plan if expenditures in excess of 
$100,000 are anticipated, for that period, for the acquisition of land; 
the improvement of land, buildings, and equipment; and the replacement, 
modernization, and expansion of buildings and equipment; and
    (iii) Annual review and updating by the governing body.
    (e) Standard: Patient care policies. The facility must have written 
patient care policies that govern the services it furnishes. The patient 
care policies must include the following:
    (1) A description of the services the facility furnishes through 
employees and those furnished under arrangements.
    (2) Rules for and personnel responsibilities in handling medical 
emergencies.
    (3) Rules for the storage, handling, and administration of drugs and 
biologicals.
    (4) Criteria for patient admission, continuing care, and discharge.
    (5) Procedures for preparing and maintaining clinical records on all 
patients.
    (6) A procedure for explaining to the patient and the patient's 
family the extent and purpose of the services to be provided.
    (7) A procedure to assist the referring physician in locating 
another level of care for--patients whose treatment has terminated and 
who are discharged.
    (8) A requirement that patients accepted by the facility must be 
under the care of a physician.
    (9) A requirement that there be a plan of treatment established by a 
physician for each patient.
    (10) A procedure to ensure that the group of professional personnel 
reviews and takes appropriate action on recommendations from the 
utilization review committee regarding patient care policies.
    (f) Standard: Delegation of authority. The responsibility for 
overall administration, management, and operation must be retained by 
the facility itself and not delegated to others.
    (1) The facility may enter into a contract for purposes of 
assistance in financial management and may delegate to others the 
following and similar services:
    (i) Bookkeeping.
    (ii) Assistance in the development of procedures for billing and 
accounting systems.
    (iii) Assistance in the development of an operating budget.
    (iv) Purchase of supplies in bulk form.
    (v) The preparation of financial statements.
    (2) When the services listed in paragraph (f)(1) of this section are 
delegated, a contract must be in effect and:
    (i) May not be for a term of more than 5 years;
    (ii) Must be subject to termination within 60 days of written notice 
by either party;
    (iii) Must contain a clause requiring renegotiation of any provision 
that CMS finds to be in contravention to any new, revised or amended 
Federal regulation or law;
    (iv) Must state that only the facility may bill the Medicare 
program; and
    (v) May not include clauses that state or imply that the contractor 
has power and authority to act on behalf of the facility, or clauses 
that give the contractor rights, duties, discretions, or 
responsibilities that enable it to dictate the administration, 
mangement, or operations of the facility.



Sec. 485.58  Condition of participation: Comprehensive rehabilitation
program.

    The facility must provide a coordinated rehabilitation program that 
includes, at a minimum, physicians' services, physical therapy services, 
and social or psychological services. These services must be furnished 
by personnel that meet the qualifications set forth in Sec. Sec. 485.70 
and 484.115 of this chapter and must be consistent with the plan of 
treatment and the results of comprehensive patient assessments.
    (a) Standard: Physician services. (1) A facility physician must be 
present in the facility for a sufficient time to--
    (i) Provide, in accordance with accepted principles of medical 
practice,

[[Page 194]]

medical direction, medical care services, consultation, and medical 
supervision of nonphysician staff;
    (ii) Establish the plan of treatment in cases where a plan has not 
been established by the referring physician;
    (iii) Assist in establishing and implementing the facility's patient 
care policies; and
    (iv) Participate in plan of treatment reviews, patient case review 
conferences, comprehensive patient assessment and reassessments, and 
utilization review.
    (2) The facility must provide for emergency physician services 
during the facility operating hours.
    (b) Standard: Plan of treatment. For each patient, a physician must 
establish a plan of treatment before the facility initiates treatment. 
The plan of treatment must meet the following requirements:
    (1) It must delineate anticipated goals and specify the type, 
amount, frequency and duration of services to be provided.
    (2) It must be promptly evaluated after changes in the patient's 
condition and revised when necessary.
    (3) It must, if appropriate, be developed in consultation with the 
facility physician and the appropriate facility professional personnel.
    (4) It must be reviewed at least every 60 days by a facility 
physician who, when appropriate, consults with the professional 
personnel providing services. The results of this review must be 
communicated to the patient's referring physician for concurrence before 
treatment is continued or discontinued.
    (5) It must be revised if the comprehensive reassessment of the 
patient's status or the results of the patient case review conference 
indicate the need for revision.
    (c) Standard: Coordination of services. The facility must designate, 
in writing, a qualified professional to ensure that professional 
personnel coordinate their related activities and exchange information 
about each patient under their care. Mechanisms to assist in the 
coordination of services must include--
    (1) Providing to all personnel associated with the facility, a 
schedule indicating the frequency and type of services provided at the 
facility;
    (2) A procedure for communicating to all patient care personnel 
pertinent information concerning significant changes in the patient's 
status;
    (3) Periodic clinical record entries, noting at least the patient's 
status in relationship to goal attainment; and
    (4) Scheduling patient case review conferences for purposes of 
determining appropriateness of treatment, when indicated by the results 
of the initial comprehensive patient assessment, reassessment(s), the 
recommendation of the facility physician (or other physician who 
established the plan of treatment), or upon the recommendation of one of 
the professionals providing services.
    (d) Standard: Provision of services. (1) All patients must be 
referred to the facility by a physician who provides the following 
information to the facility before treatment is initiated:
    (i) The patient's significant medical history.
    (ii) Current medical findings.
    (iii) Diagnosis(es) and contraindications to any treatment modality.
    (iv) Rehabilitation goals, if determined.
    (2) Services may be provided by facility employees or by others 
under arrangements made by the facility.
    (3) The facility must have on its premises the necessary equipment 
to implement the plan of treatment and sufficient space to allow 
adequate care.
    (4) The services must be furnished by personnel that meet the 
qualifications of Sec. 485.70 and the number of qualified personnel 
must be adequate for the volume and diversity of services offered. 
Personnel that do not meet the qualifications specified in Sec. 485.70 
may be used by the facility in assisting qualified staff. When a 
qualified individual is assisted by these personnel, the qualified 
individual must be on the premises, and must instruct these personnel in 
appropriate patient care service techniques and retain responsibility 
for their activities.
    (5) A qualified professional must initiate and coordinate the 
appropriate

[[Page 195]]

portions of the plan of treatment, monitor the patient's progress, and 
recommend changes, in the plan, if necessary.
    (6) A qualified professional representing each service made 
available at the facility must be either on the premises of the facility 
or must be available through direct telecommunication for consultation 
and assistance during the facility's operating hours. At least one 
qualified professional must be on the premises during the facility's 
operating hours.
    (7) All services must be provided consistent with accepted 
professional standards and practice.
    (e) Standard: Scope and site of services--(1) Basic requirements. 
The facility must provide all the CORF services required in the plan of 
treatment and, except as provided in paragraph (e)(2) of this section, 
must provide the services on its premises.
    (2) Exceptions. Physical therapy, occupational therapy, and speech-
language pathology services may be furnished away from the premises of 
the CORF including the individual's home when payment is not otherwise 
made under Title XVIII of the Act. In addition, a single home 
environment evaluation is covered if there is a need to evaluate the 
potential impact of the home environment on the rehabilitation goals. 
The single home environment evaluation requires the presence of the 
patient and the physical therapist, occupational therapist, or speech-
language pathologist, as appropriate.
    (f) Standard: Patient assessment. Each qualified professional 
involved in the patient's care, as specified in the plan of treatment, 
must--
    (1) Carry out an initial patient assessment; and
    (2) In order to identify whether or not the current plan of 
treatment is appropriate, perform a patient reassessment after 
significant changes in the patient's status.
    (g) Standard: Laboratory services. (1) If the facility provides its 
own laboratory services, the services must meet the applicable 
requirements for laboratories specified in part 493 of this chapter.
    (2) If the facility chooses to refer specimens for laboratory 
testing, the referral laboratory must be certified in the appropriate 
specialties and subspecialties of services in accordance with the 
requirements of part 493 of this chapter.

[48 FR 56293, Dec. 15, 1982, as amended at 56 FR 8852, Mar. 1, 1991; 57 
FR 7137, Feb. 28, 1992; 73 FR 69941, Nov. 19, 2008; 82 FR 4591, Jan. 13, 
2017]



Sec. 485.60  Condition of participation: Clinical records.

    The facility must maintain clinical records on all patients in 
accordance with accepted professional standards and practice. The 
clinical records must be completely, promptly, and accurately 
documented, readily accessible, and systematically organized to 
facilitate retrieval and compilation of information.
    (a) Standard: Content. Each clinical record must contain sufficient 
information to identify the patient clearly and to justify the diagnosis 
and treatment. Entries in the clinical record must be made as frequently 
as is necessary to insure effective treatment and must be signed by 
personnel providing services. All entries made by assistant level 
personnel must be countersigned by the corresponding professional. 
Documentation on each patient must be consolidated into one clinical 
record that must contain--
    (1) The initial assessment and subsequent reassessments of the 
patient's needs;
    (2) Current plan of treatment;
    (3) Identification data and consent or authorization forms;
    (4) Pertinent medical history, past and present;
    (5) A report of pertinent physical examinations if any;
    (6) Progress notes or other documentation that reflect patient 
reaction to treatment, tests, or injury, or the need to change the 
established plan of treatment; and
    (7) Upon discharge, a discharge summary including patient status 
relative to goal achievement, prognosis, and future treatment 
considerations.
    (b) Standard: Protection of clinical record information. The 
facility must safeguard clinical record information

[[Page 196]]

against loss, destruction, or unauthorized use. The facility must have 
procedures that govern the use and removal of records and the conditions 
for release of information. The facility must obtain the patient's 
written consent before releasing information not required to be released 
by law.
    (c) Standard: Retention and preservation. The facility must retain 
clinical record information for 5 years after patient discharge and must 
make provision for the maintenance of such records in the event that it 
is no longer able to treat patients.



Sec. 485.62  Condition of participation: Physical environment.

    The facility must provide a physical environment that protects the 
health and safety or patients, personnel, and the public.
    (a) Standard: Safety and comfort of patients. The physical premises 
of the facility and those areas of its surrounding physical structure 
that are used by the patients (including at least all stairwells, 
corridors and passageways) must meet the following requirements:
    (1) Applicable Federal, State, and local building, fire, and safety 
codes must be met.
    (2) Fire extinguishers must be easily accessible and fire 
regulations must be prominently posted.
    (3) A fire alarm system with local (in-house) capability must be 
functional, and where power is generated by electricity, an alternate 
power source with automatic triggering must be present.
    (4) Lights, supported by an emergency power source, must be placed 
at exits.
    (5) A sufficient number of staff to evacuate patients during a 
disaster must be on the premises of the facility whenever patients are 
being treated.
    (6) Lighting must be sufficient to carry out services safely; room 
temperature must be maintained at comfortable levels; and ventilation 
through windows, mechanical means, or a combination of both must be 
provided.
    (7) Safe and sufficient space must be available for the scope of 
services offered.
    (b) Standard: Sanitary environment. The facility must maintain a 
sanitary environment and establish a program to identify, investigate, 
prevent, and control the cause of patient infections.
    (1) The facility must establish written policies and procedures 
designed to control and prevent infection in the facility and to 
investigate and identify possible causes of infection.
    (2) The facility must monitor the infection control program to 
ensure that the staff implement the policies and procedures and that the 
policies and procedures are consistent with current practices in the 
field.
    (3) The facility must make available at all times a quantity of 
laundered linen adequate for proper care and comfort of patients. Linens 
must be handled, stored, and processed in a manner that prevents the 
spread of infection.
    (4) Provisions must be in effect to ensure that the facility's 
premises are maintained free of rodent and insect infestation.
    (c) Standard: Maintenance of equipment, physical location, and 
grounds. The facility must establish a written preventive maintenance 
program to ensure that--
    (1) All equipment is properly maintained and equipment needing 
periodic calibration is calibrated consistent with the manufacturer's 
recommendations; and
    (2) The interior of the facility, the exterior of the physical 
structure housing the facility, and the exterior walkways and parking 
areas are clean and orderly and maintained free of any defects that are 
a hazard to patients, personnel, and the public.
    (d) Standard: Access for the physically impaired. The facility must 
ensure the following:
    (1) Doorways, stairwells, corridors, and passageways used by 
patients are--
    (i) Of adequate width to allow for easy movement of all patients 
(including those on stretchers or in wheelchairs); and
    (ii) In the case of stairwells, equipped with firmly attached 
handrails on at least one side.
    (2) At least one toilet facility is accessible and constructed to 
allow utilization by ambulatory and nonambulatory individuals.

[[Page 197]]

    (3) At least one entrance is usable by individuals in wheelchairs.
    (4) In multi-story buildings, elevators are accessible to and usable 
by the physically impaired on the level that they use to enter the 
building and all levels normally used by the patients of the facility.
    (5) Parking spaces are large enough and close enough to the facility 
to allow safe access by the physically impaired.



Sec. 485.64  [Reserved]



Sec. 485.66  Condition of participation: Utilization review plan.

    The facility must have in effect a written utilization review plan 
that is implemented annually, to assess the necessity of services and 
promotes the most efficient use of services provided by the facility.
    (a) Standard: Utilization review committee. The utilization review 
committee, consisting of the group of professional personnel specified 
in Sec. 485.56(c), a committee of this group, or a group of similar 
composition, comprised by professional personnel not associated with the 
facility, must carry out the utilization review plan.
    (b) Standard: Utilization review plan. The utilization review plan 
must contain written procedures for evaluating--
    (1) Admissions, continued care, and discharges using, at a minimum, 
the criteria established in the patient care policies;
    (2) The applicability of the plan of treatment to established goals; 
and
    (3) The adequacy of clinical records with regard to--
    (i) Assessing the quality of services provided; and
    (ii) Determining whether the facility's policies and clinical 
practices are compatible and promote appropriate and efficient 
utilization of services.

[48 FR 56293, Dec. 15, 1982. Redesignated at 50 FR 33034, Aug. 16, 1985, 
as amended at 84 FR 51826, Sept. 30, 2019]



Sec. 485.68  Condition of participation: Emergency preparedness.

    The Comprehensive Outpatient Rehabilitation Facility (CORF) must 
comply with all applicable Federal, State, and local emergency 
preparedness requirements. The CORF 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 CORF must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the CORF 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.
    (5) Be developed and maintained with assistance from fire, safety, 
and other appropriate experts.
    (b) Policies and procedures. The CORF 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) Safe evacuation from the CORF, which includes staff 
responsibilities, and needs of the patients.
    (2) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (3) A system of medical documentation that preserves patient 
information, protects confidentiality of patient

[[Page 198]]

information, and secures and maintains the availability of records.
    (4) The use of volunteers in an emergency and 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.
    (c) Communication plan. The CORF 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) Patients' physicians.
    (iv) Other CORFs.
    (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 CORF's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
patients under the CORF's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means of providing information about the CORF's needs, and its 
ability to provide assistance, to the authority having jurisdiction or 
the Incident Command Center, or designee.
    (d) Training and testing. The CORF 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 CORF 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) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures. All new 
personnel must be oriented and assigned specific responsibilities 
regarding the CORF's emergency plan within 2 weeks of their first 
workday. The training program must include instruction in the location 
and use of alarm systems and signals and firefighting equipment.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the CORF must conduct training on the updated 
policies and procedures.
    (2) Testing. The CORF must conduct exercises to test the emergency 
plan at least annually. The CORF must do the following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, conduct an 
individual, facility-based functional exercise every 2 years; or
    (B) If the CORF experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CORF is exempt from 
engaging in its next required 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,

[[Page 199]]

and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the CORF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CORF's emergency plan, as needed.
    (e) Integrated healthcare systems. If a CORF 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 CORF may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of 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 64035, Sept. 16, 2016, as amended at 84 FR 51826, Sept. 30, 2019]



Sec. 485.70  Personnel qualifications.

    This section sets forth the qualifications that must be met, as a 
condition of participation, under Sec. 485.58, and as a condition of 
coverage of services under Sec. 410.100 of this chapter.
    (a) A facility physician must be a doctor of medicine or osteopathy 
who--
    (1) Is licensed under State law to practice medicine or surgery; and
    (2) Has had, subsequent to completing a 1-year hospital internship, 
at least 1 year of training in the medical management of patients 
requiring rehabilitation services; or
    (3) Has had at least 1 year of full-time or part-time experience in 
a rehabilitation setting providing physicians' services similar to those 
required in this subpart.
    (b) A licensed practical nurse must be licensed as a practical or 
vocational nurse by the State in which practicing, if applicable.
    (c) An occupational therapist and an occupational therapy assistant 
must meet the qualifications in Sec. 484.115 of this chapter.
    (d) An orthotist must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a training program in orthotics that 
is jointly recognized by the American Council on Education and the 
American Board for Certification in Orthotics and Prosthetics; and
    (3) Be eligible to take that Board's certification examination in 
orthotics.
    (e) A physical therapist and a physical therapist assistant must 
meet the qualifications in Sec. 484.115 of this chapter.
    (f) A prosthetist must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a training program in prosthetics 
that is jointly recognized by the American Council on Education and the 
American Board for Certification in Orthotics and Prosthetics; and

[[Page 200]]

    (3) Be eligible to take that Board's certification examination in 
prosthetics.
    (g) A psychologist must be certified or licensed by the State in 
which he or she is practicing, if that State requires certification or 
licensing, and must hold a masters degree in psychology from and 
educational institution approved by the State in which the institution 
is located.
    (h) A registered nurse must be a graduate of an approved school of 
nursing and be licensed as a registered nurse by the State in which 
practicing, if applicable.
    (i) A rehabilitation counselor must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Hold at least a bachelor's degree; and
    (3) Be eligible to take the certification examination administered 
by the Commission on Rehabilitation Counselor Certification.
    (j) A respiratory therapist must complete one the following 
criteria:
    (1) Criterion 1. All of the following must be completed:
    (i) Be licensed by the State in which practicing, if applicable.
    (ii) Have successfully completed a nationally-accredited educational 
program for respiratory therapists.
    (iii)(A) Be eligible to take the registry examination administered 
by the National Board for Respiratory Care for respiratory therapists; 
or
    (B) Have passed the registry examination administered by the 
National Board for Respiratory Care for respiratory therapists.
    (2) Criterion 2: All of the following must be completed:
    (i) Be licensed by the State in which practicing, if applicable.
    (ii) Have equivalent training and experience as determined by the 
National Board for Respiratory Care.
    (k) A respiratory therapy technician must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a training program accredited by the 
Committees on Allied Health Education and Accreditation (CAHEA) in 
collaboration with the Joint Review Committee for Respiratory Therapy 
Education; and
    (3) Either--
    (i) Be eligible to take the certification examination for 
respiratory therapy technicians administered by the National Board for 
Respiratory Therapy, Inc,; or
    (ii) Have equivalent training and experience as determined by the 
National Board for Respiratory Therapy, Inc.
    (l) A social worker must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Hold at least a bachelor's degree from a school accredited or 
approved by the Council on Social Work Education; and
    (3) Have 1 year of social work experience in a health care setting.
    (m) A speech-language pathologist must meet the qualifications set 
forth in part 484 of this chapter.

[48 FR 56293, Dec. 15, 1982. Redesignated and amended at 50 FR 33034, 
Aug. 16, 1985; 51 FR 41352, Nov. 14, 1986; 60 FR 2327, Jan. 9, 1995; 72 
FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 74 FR 62014, Nov. 
25, 2009; 82 FR 4591, Jan. 13, 2017]



Sec. 485.74  Appeal rights.

    The appeal provisions set forth in part 498 of this chapter, for 
providers, are applicable to any entity that is participating or seeks 
to participate in the Medicare program as a CORF.

[48 FR 56293, Dec. 15, 1982, as amended at 52 FR 22454, June 12, 1987]

Subparts C-E [Reserved]



 Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)

    Source: 58 FR 30671, May 26, 1993, unless otherwise noted.



Sec. 485.601  Basis and scope.

    (a) Statutory basis. This subpart is based on section 1820 of the 
Act which sets forth the conditions for designating certain hospitals as 
CAHs.
    (b) Scope. This subpart sets forth the conditions that a hospital 
must meet to be designated as a CAH.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]

[[Page 201]]



Sec. 485.603  Rural health network.

    A rural health network is an organization that meets the following 
specifications:
    (a) It includes--
    (1) At least one hospital that the State has designated or plans to 
designate as a CAH; and
    (2) At least one hospital that furnishes acute care services.
    (b) The members of the organization have entered into agreements 
regarding--
    (1) Patient referral and transfer;
    (2) The development and use of communications systems, including, 
where feasible, telemetry systems and systems for electronic sharing of 
patient data; and
    (3) The provision of emergency and nonemergency transportation among 
members.
    (c) Each CAH has an agreement with respect to credentialing and 
quality assurance with at least--
    (1) One hospital that is a member of the network when applicable;
    (2) One QIO or equivalent entity; or
    (3) One other appropriate and qualified entity identified in the 
State rural health care plan.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46035, Aug. 29, 1997; 63 
FR 26359, May 12, 1998]



Sec. 485.604  Personnel qualifications.

    Staff that furnish services in a CAH must meet the applicable 
requirements of this section.
    (a) Clinical nurse specialist. A clinical nurse specialist must be a 
person who--
    (1) Is a registered nurse and is licensed to practice nursing in the 
State in which the clinical nurse specialist services are performed in 
accordance with State nurse licensing laws and regulations; and
    (2) Holds a master's or doctoral level degree in a defined clinical 
area of nursing from an accredited educational institution.
    (b) Nurse practitioner. A nurse practitioner must be a registered 
professional nurse who is currently licensed to practice in the State, 
who meets the State's requirements governing the qualification of nurse 
practitioners, and who meets one of the following conditions:
    (1) Is currently certified as a primary care nurse practitioner by 
the American Nurses' Association or by the National Board of Pediatric 
Nurse Practitioners and Associates.
    (2) Has successfully completed a 1 academic year program that--
    (i) Prepares registered nurses to perform an expanded role in the 
delivery of primary care;
    (ii) Includes at least 4 months (in the aggregate) of classroom 
instruction and a component of supervised clinical practice; and
    (iii) Awards a degree, diploma, or certificate to persons who 
successfully complete the program.
    (3) Has successfully completed a formal educational program (for 
preparing registered nurses to perform an expanded role in the delivery 
of primary care) that does not meet the requirements of paragraph (a)(2) 
of this section, and has been performing an expanded role in the 
delivery of primary care for a total of 12 months during the 18-month 
period immediately preceding June 25, 1993.
    (c) Physician assistant. A physician assistant must be a person who 
meets the applicable State requirements governing the qualifications for 
assistants to primary care physicians, and who meets at least one of the 
following conditions:
    (1) Is currently certified by the National Commission on 
Certification of Physician Assistants to assist primary care physicians.
    (2) Has satisfactorily completed a program for preparing physician 
assistants that--
    (i) Was at least one academic year in length;
    (ii) Consisted of supervised clinical practice and at least 4 months 
(in the aggregate) of classroom instruction directed toward preparing 
students to deliver health care; and
    (iii) Was accredited by the American Medical Association's Committee 
on Allied Health Education and Accreditation.
    (3) Has satisfactorily completed a formal educational program (for 
preparing physician assistants) that does not meet the requirements of 
paragraph (c)(2) of this section and has been assisting primary care 
physicians for a

[[Page 202]]

total of 12 months during the 18-month period immediately preceding June 
25, 1993.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 77 
FR 29076, May 16, 2012]



Sec. 485.606  Designation and certification of CAHs.

    (a) Criteria for State designation. (1) A State that has established 
a Medicare rural hospital flexibility program described in section 
1820(c) of the Act may designate one or more facilities as CAHs if each 
facility meets the CAH conditions of participation in this subpart F.
    (2) The State must not deny any hospital that is otherwise eligible 
for designation as a CAH under this paragraph (a) solely because the 
hospital has entered into an agreement under which the hospital may 
provide posthospital SNF care as described in Sec. 482.58 of this 
chapter.
    (b) Criteria for CMS certification. CMS certifies a facility as a 
CAH if--
    (1) The facility is designated as a CAH by the State in which it is 
located and has been surveyed by the State survey agency or by CMS and 
found to meet all conditions of participation in this part and all other 
applicable requirements for participation in part 489 of this chapter.
    (2) The facility is a medical assistance facility operating in 
Montana or a rural primary care hospital designated by CMS before August 
5, 1997, and is otherwise eligible to be designated as a CAH by the 
State under the rules in this subpart.

[62 FR 46036, Aug. 29, 1997, as amended at 63 FR 26359, May 12, 1998; 79 
FR 27155, May 12, 2014]



Sec. 485.608  Condition of participation: Compliance with Federal, 
State, and local laws and regulations.

    The CAH and its staff are in compliance with applicable Federal, 
State and local laws and regulations.
    (a) Standard: Compliance with Federal laws and regulations. The CAH 
is in compliance with applicable Federal laws and regulations related to 
the health and safety of patients.
    (b) Standard: Compliance with State and local laws and regulations. 
All patient care services are furnished in accordance with applicable 
State and local laws and regulations.
    (c) Standard: Licensure of CAH. The CAH is licensed in accordance 
with applicable Federal, State and local laws and regulations.
    (d) Standard: Licensure, certification or registration of personnel. 
Staff of the CAH are licensed, certified, or registered in accordance 
with applicable Federal, State, and local laws and regulations.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]



Sec. 485.610  Condition of participation: Status and location.

    (a) Standard: Status. The facility is--
    (1) A currently participating hospital that meets all conditions of 
participation set forth in this subpart;
    (2) A recently closed facility, provided that the facility--
    (i) Was a hospital that ceased operations on or after the date that 
is 10 years before November 29, 1999; and
    (ii) Meets the criteria for designation under this subpart as of the 
effective date of its designation; or
    (3) A health clinic or a health center (as defined by the State) 
that--
    (i) Is licensed by the State as a health clinic or a health center;
    (ii) Was a hospital that was downsized to a health clinic or a 
health center; and
    (iii) As of the effective date of its designation, meets the 
criteria for designation set forth in this subpart.
    (b) Standard: Location in a rural area or treatment as rural. The 
CAH meets the requirements of either paragraph (b)(1) or (b)(2) of this 
section or the requirements of paragraph (b)(3), (b)(4), or (b)(5) of 
this section.
    (1) The CAH meets the following requirements:
    (i) The CAH is located outside any area that is a Metropolitan 
Statistical Area, as defined by the Office of Management and Budget, or 
that has been recognized as urban under Sec. 412.64(b), excluding 
paragraph (b)(3) of this chapter;
    (ii) The CAH has not been classified as an urban hospital for 
purposes of the standardized payment amount by CMS

[[Page 203]]

or the Medicare Geographic Classification Review Board under Sec. 
412.230(e) of this chapter, and is not among a group of hospitals that 
have been redesignated to an adjacent urban area under Sec. 412.232 of 
this chapter.
    (2) The CAH is located within a Metropolitan Statistical Area, as 
defined by the Office of Management and Budget, but is being treated as 
being located in a rural area in accordance with Sec. 412.103 of this 
chapter.
    (3) Effective for October 1, 2004 through September 30, 2006, the 
CAH does not meet the location requirements in either paragraph (b)(1) 
or (b)(2) of this section and is located in a county that, in FY 2004, 
was not part of a Metropolitan Statistical Area as defined by the Office 
of Management and Budget, but as of FY 2005 was included as part of such 
a Metropolitan Statistical Area as a result of the most recent census 
data and implementation of the new Metropolitan Statistical Area 
definitions announced by the Office of Management and Budget on June 3, 
2003.
    (4) Effective for October 1, 2009 through September 30, 2011, the 
CAH does not meet the location requirements in either paragraph (b)(1) 
or (b)(2) of this section and is located in a county that, in FY 2009, 
was not part of a Metropolitan Statistical Area as defined by the Office 
of Management and Budget, but, as of FY 2010, was included as part of 
such a Metropolitan Statistical Area as a result of the most recent 
census data and implementation of the new Metropolitan Statistical Area 
definitions announced by the Office of Management and Budget on November 
20, 2008.
    (5) Effective on or after October 1, 2014, for a period of 2 years 
beginning with the effective date of the most recent Office of 
Management and Budget (OMB) standards for delineating statistical areas 
adopted by CMS, the CAH no longer meets the location requirements in 
either paragraph (b)(1) or (b)(2) of this section and is located in a 
county that, prior to the most recent OMB standards for delineating 
statistical areas adopted by CMS and the most recent Census Bureau data, 
was located in a rural area as defined by OMB, but under the most recent 
OMB standards for delineating statistical areas adopted by CMS and the 
most recent Census Bureau data, is located in an urban area.
    (c) Standard: Location relative to other facilities or necessary 
provider certification. The CAH is located more than a 35-mile drive 
(or, in the case of mountainous terrain or in areas with only secondary 
roads available, a 15-mile drive) from a hospital or another CAH, or 
before January 1, 2006, the CAH is certified by the State as being a 
necessary provider of health care services to residents in the area. A 
CAH that is designated as a necessary provider on or before December 31, 
2005, will maintain its necessary provider designation after January 1, 
2006.
    (d) Standard: Relocation of CAHs with a necessary provider 
designation. A CAH that has a necessary provider designation from the 
State that was in effect prior to January 1, 2006, and relocates its 
facility after January 1, 2006, can continue to meet the location 
requirement of paragraph (c) of this section based on the necessary 
provider designation only if the relocated facility meets the 
requirements as specified in paragraph (d)(1) of this section.
    (1) If a necessary provider CAH relocates its facility and begins 
providing services in a new location, the CAH can continue to meet the 
location requirement of paragraph (c) of this section based on the 
necessary provider designation only if the CAH in its new location--
    (i) Serves at least 75 percent of the same service area that it 
served prior to its relocation;
    (ii) Provides at least 75 percent of the same services that it 
provided prior to the relocation; and
    (iii) Is staffed by 75 percent of the same staff (including medical 
staff, contracted staff, and employees) that were on staff at the 
original location.
    (2) If a CAH that has been designated as a necessary provider by the 
State begins providing services at another location after January 1, 
2006, and does not meet the requirements in paragraph (d)(1) of this 
section, the action will be considered a cessation of business as 
described in Sec. 489.52(b)(3).
    (e) Standard: Off-campus and co-location requirements for CAHs. A 
CAH may

[[Page 204]]

continue to meet the location requirements of paragraph (c) of this 
section only if the CAH meets the following:
    (1) If a CAH with a necessary provider designation is co-located 
(that is, it shares a campus, as defined in Sec. 413.65(a)(2) of this 
chapter, with another hospital or CAH), the necessary provider CAH can 
continue to meet the location requirement of paragraph (c) of this 
section only if the co-location arrangement was in effect before January 
1, 2008, and the type and scope of services offered by the facility co-
located with the necessary provider CAH do not change. A change of 
ownership of any of the facilities with a co-location arrangement that 
was in effect before January 1, 2008, will not be considered to be a new 
co-location arrangement.
    (2) If a CAH or a necessary provider CAH operates an off-campus 
provider-based location, excluding an RHC as defined in Sec. 
405.2401(b) of this chapter, but including a department or remote 
location, as defined in Sec. 413.65(a)(2) of this chapter, or an off-
campus distinct part psychiatric or rehabilitation unit, as defined in 
Sec. 485.647, that was created or acquired by the CAH on or after 
January 1, 2008, the CAH can continue to meet the location requirement 
of paragraph (c) of this section only if the off-campus provider-based 
location or off-campus distinct part unit is located more than a 35-mile 
drive (or, in the case of mountainous terrain or in areas with only 
secondary roads available, a 15-mile drive) from a hospital or another 
CAH.
    (3) If either a CAH or a CAH that has been designated as a necessary 
provider by the State does not meet the requirements in paragraph (e)(1) 
of this section, by co-locating with another hospital or CAH on or after 
January 1, 2008, or creates or acquires an off-campus provider-based 
location or off-campus distinct part unit on or after January 1, 2008, 
that does not meet the requirements in paragraph (e)(2) of this section, 
the CAH's provider agreement will be subject to termination in 
accordance with the provisions of Sec. 489.53(a)(3) of this subchapter, 
unless the CAH terminates the off-campus arrangement or the co-location 
arrangement, or both.

[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 66 
FR 39938, Aug. 1, 2001; 69 FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 
2004; 70 FR 47490, Aug. 12, 2005; 71 FR 48143, Aug. 18, 2006; 72 FR 
66934, Nov. 27, 2007; 73 FR 9862, Feb. 22, 2008; 74 FR 44001, Aug. 27, 
2009; 75 FR 50418, Aug. 16, 2010; 79 FR 50359, Aug. 22, 2014]



Sec. 485.612  Condition of participation: Compliance with hospital
requirements at the time of application.

    Except for recently closed facilities as described in Sec. 
485.610(a)(2), or health clinics or health centers as described in Sec. 
485.610(a)(3), the facility is a hospital that has a provider agreement 
to participate in the Medicare program as a hospital at the time the 
hospital applies for designation as a CAH.

[66 FR 32196, June 13, 2001]



Sec. 485.616  Condition of participation: Agreements.

    (a) Standard: Agreements with network hospitals. In the case of a 
CAH that is a member of a rural health network as defined in Sec. 
485.603 of this chapter, the CAH has in effect an agreement with at 
least one hospital that is a member of the network for--
    (1) Patient referral and transfer;
    (2) The development and use of communications systems of the 
network, including the network's system for the electronic sharing of 
patient data, and telemetry and medical records, if the network has in 
operation such a system; and
    (3) The provision of emergency and nonemergency transportation 
between the facility and the hospital.
    (b) Standard: Agreements for credentialing and quality assurance. 
Each CAH that is a member of a rural health network shall have an 
agreement with respect to credentialing and quality assurance with at 
least--
    (1) One hospital that is a member of the network;
    (2) One QIO or equivalent entity; or
    (3) One other appropriate and qualified entity identified in the 
State rural health care plan.
    (c) Standard: Agreements for credentialing and privileging of 
telemedicine physicians and practitioners. (1) The

[[Page 205]]

governing body of the CAH must ensure that, when telemedicine services 
are furnished to the CAH's patients through an agreement with a distant-
site hospital, the agreement is written and specifies that it is the 
responsibility of the governing body of the distant-site hospital to 
meet the following requirements with regard to its physicians or 
practitioners providing telemedicine services:
    (i) Determine, in accordance with State law, which categories of 
practitioners are eligible candidates for appointment to the medical 
staff.
    (ii) Appoint members of the medical staff after considering the 
recommendations of the existing members of the medical staff.
    (iii) Assure that the medical staff has bylaws.
    (iv) Approve medical staff bylaws and other medical staff rules and 
regulations.
    (v) Ensure that the medical staff is accountable to the governing 
body for the quality of care provided to patients.
    (vi) Ensure the criteria for selection are individual character, 
competence, training, experience, and judgment.
    (vii) Ensure that under no circumstances is the accordance of staff 
membership or professional privileges in the hospital dependent solely 
upon certification, fellowship or membership in a specialty body or 
society.
    (2) When telemedicine services are furnished to the CAH's patients 
through an agreement with a distant-site hospital, the CAH's governing 
body or responsible individual may choose to rely upon the credentialing 
and privileging decisions made by the governing body of the distant-site 
hospital regarding individual distant-site physicians or practitioners. 
The CAH's governing body or responsible individual must ensure, through 
its written agreement with the distant-site hospital, that the following 
provisions are met:
    (i) The distant-site hospital providing telemedicine services is a 
Medicare-participating hospital.
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site hospital providing the telemedicine 
services, which provides a current list of the distant-site physician's 
or practitioner's privileges at the distant-site hospital;
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the CAH is located; 
and
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the CAH whose patients are receiving the 
telemedicine services, the CAH has evidence of an internal review of the 
distant-site physician's or practitioner's performance of these 
privileges and sends the distant-site hospital such information for use 
in the periodic appraisal of the individual distant-site physician or 
practitioner. At a minimum, this information must include all adverse 
events that result from the telemedicine services provided by the 
distant-site physician or practitioner to the CAH's patients and all 
complaints the CAH has received about the distant-site physician or 
practitioner.
    (3) The governing body of the CAH must ensure that when telemedicine 
services are furnished to the CAH's patients through an agreement with a 
distant-site telemedicine entity, the agreement is written and specifies 
that the distant-site telemedicine entity is a contractor of services to 
the CAH and as such, in accordance with Sec. 485.635(c)(4)(ii), 
furnishes the contracted services in a manner that enables the CAH to 
comply with all applicable conditions of participation for the 
contracted services, including, but not limited to, the requirements in 
this section with regard to its physicians and practitioners providing 
telemedicine services.
    (4) When telemedicine services are furnished to the CAH's patients 
through an agreement with a distant-site telemedicine entity, the CAH's 
governing body or responsible individual may choose to rely upon the 
credentialing and privileging decisions made by the governing body of 
the distant-site telemedicine entity regarding individual distant-site 
physicians or practitioners. The CAH's governing body or responsible 
individual must ensure, through its written agreement with the distant-
site telemedicine entity, that the following provisions are met:

[[Page 206]]

    (i) The distant-site telemedicine entity's medical staff 
credentialing and privileging process and standards at least meet the 
standards at paragraphs (c)(1)(i) through (c)(1)(vii) of this section.
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site telemedicine entity providing the 
telemedicine services, which provides a current list to the CAH of the 
distant-site physician's or practitioner's privileges at the distant-
site telemedicine entity.
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the CAH whose 
patients are receiving the telemedicine services is located.
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the CAH whose patients are receiving the 
telemedicine services, the CAH has evidence of an internal review of the 
distant-site physician's or practitioner's performance of these 
privileges and sends the distant-site telemedicine entity such 
information for use in the periodic appraisal of the distant-site 
physician or practitioner. At a minimum, this information must include 
all adverse events that result from the telemedicine services provided 
by the distant-site physician or practitioner to the CAH's patients and 
all complaints the CAH has received about the distant-site physician or 
practitioner.

[62 FR 46036, Aug. 29, 1997, as amended at 76 FR 25564, May 5, 2011]



Sec. 485.618  Condition of participation: Emergency services.

    The CAH provides emergency care necessary to meet the needs of its 
inpatients and outpatients.
    (a) Standard: Availability. Emergency services are available on a 
24-hours a day basis.
    (b) Standard: Equipment, supplies, and medication. Equipment, 
supplies, and medication used in treating emergency cases are kept at 
the CAH and are readily available for treating emergency cases. The 
items available must include the following:
    (1) Drugs and biologicals commonly used in life-saving procedures, 
including analgesics, local anesthetics, antibiotics, anticonvulsants, 
antidotes and emetics, serums and toxoids, antiarrythmics, cardiac 
glycosides, antihypertensives, diuretics, and electrolytes and 
replacement solutions.
    (2) Equipment and supplies commonly used in life-saving procedures, 
including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, 
tourniquets, immobilization devices, nasogastric tubes, splints, IV 
therapy supplies, suction machine, defibrillator, cardiac monitor, chest 
tubes, and indwelling urinary catheters.
    (c) Standard: Blood and blood products. The facility provides, 
either directly or under arrangements, the following:
    (1) Services for the procurement, safekeeping, and transfusion of 
blood, including the availability of blood products needed for 
emergencies on a 24-hours a day basis.
    (2) Blood storage facilities that meet the requirements of 42 CFR 
part 493, subpart K, and are under the control and supervision of a 
pathologist or other qualified doctor of medicine or osteopathy. If 
blood banking services are provided under an arrangement, the 
arrangement is approved by the facility's medical staff and by the 
persons directly responsible for the operation of the facility.
    (d) Standard: Personnel. (1) Except as specified in paragraph (d)(3) 
of this section, there must be a doctor of medicine or osteopathy, a 
physician assistant, a nurse practitioner, or a clinical nurse 
specialist, with training or experience in emergency care, on call and 
immediately available by telephone or radio contact, and available on 
site within the following timeframes:
    (i) Within 30 minutes, on a 24-hour a day basis, if the CAH is 
located in an area other than an area described in paragraph (d)(1)(ii) 
of this section; or
    (ii) Within 60 minutes, on a 24-hour a day basis, if all of the 
following requirements are met:
    (A) The CAH is located in an area designated as a frontier area 
(that is, an area with fewer than six residents per square mile based on 
the latest population data published by the Bureau of the Census) or in 
an area that meets the criteria for a remote location adopted by the 
State in its rural

[[Page 207]]

health care plan, and approved by CMS, under section 1820(b) of the Act.
    (B) The State has determined, under criteria in its rural health 
care plan, that allowing an emergency response time longer than 30 
minutes is the only feasible method of providing emergency care to 
residents of the area served by the CAH.
    (C) The State maintains documentation showing that the response time 
of up to 60 minutes at a particular CAH it designates is justified 
because other available alternatives would increase the time needed to 
stabilize a patient in an emergency.
    (2) A registered nurse with training and experience in emergency 
care can be utilized to conduct specific medical screening examinations 
only if--
    (i) The registered nurse is on site and immediately available at the 
CAH when a patient requests medical care; and
    (ii) The nature of the patient's request for medical care is within 
the scope of practice of a registered nurse and consistent with 
applicable State laws and the CAH's bylaws or rules and regulations.
    (3) A registered nurse satisfies the personnel requirement specified 
in paragraph (d)(1) of this section for a temporary period if--
    (i) The CAH has no greater than 10 beds;
    (ii) The CAH is located in an area designated as a frontier area or 
remote location as described in paragraph (d)(1)(ii)(A) of this section;
    (iii) The State in which the CAH is located submits a letter to CMS 
signed by the Governor, following consultation on the issue of using RNs 
on a temporary basis as part of their State rural healthcare plan with 
the State Boards of Medicine and Nursing, and in accordance with State 
law, requesting that a registered nurse with training and experience in 
emergency care be included in the list of personnel specified in 
paragraph (d)(1) of this section. The letter from the Governor must 
attest that he or she has consulted with State Boards of Medicine and 
Nursing about issues related to access to and the quality of emergency 
services in the States. The letter from the Governor must also describe 
the circumstances and duration of the temporary request to include the 
registered nurses on the list of personnel specified in paragraph (d)(1) 
of this section;
    (iv) Once a Governor submits a letter, as specified in paragraph 
(d)(3)(iii) of this section, a CAH must submit documentation to the 
State survey agency demonstrating that it has been unable, due to the 
shortage of such personnel in the area, to provide adequate coverage as 
specified in this paragraph (d).
    (4) The request, as specified in paragraph (d)(3)(iii) of this 
section, and the withdrawal of the request, may be submitted to us at 
any time, and are effective upon submission.
    (e) Standard: Coordination with emergency response systems. The CAH 
must, in coordination with emergency response systems in the area, 
establish procedures under which a doctor of medicine or osteopathy is 
immediately available by telephone or radio contact on a 24-hours a day 
basis to receive emergency calls, provide information on treatment of 
emergency patients, and refer patients to the CAH or other appropriate 
locations for treatment.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 64 
FR 41544, July 30, 1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, Aug. 
11, 2004; 71 FR 68230, Nov. 24, 2006]



Sec. 485.620  Condition of participation: Number of beds and length
of stay.

    (a) Standard: Number of beds. Except as permitted for CAHs having 
distinct part units under Sec. 485.647, the CAH maintains no more than 
25 inpatient beds. Inpatient beds may be used for either inpatient or 
swing-bed services.
    (b) Standard: Length of stay. The CAH provides acute inpatient care 
for a period that does not exceed, on an annual average basis, 96 hours 
per patient.

[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 69 
FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004; 78 FR 50970, Aug. 
19, 2013]



Sec. 485.623  Condition of participation: Physical plant and environment.

    (a) Standard: Construction. The CAH is constructed, arranged, and 
maintained

[[Page 208]]

to ensure access to and safety of patients, and provides adequate space 
for the provision of services.
    (b) Standard: Maintenance. The CAH has housekeeping and preventive 
maintenance programs to ensure that--
    (1) All essential mechanical, electrical, and patient-care equipment 
is maintained in safe operating condition;
    (2) There is proper routine storage and prompt disposal of trash;
    (3) Drugs and biologicals are appropriately stored;
    (4) The premises are clean and orderly; and
    (5) There is proper ventilation, lighting, and temperature control 
in all pharmaceutical, patient care, and food preparation areas.
    (c) Standard: Life safety from fire. (1) Except as otherwise 
provided in this section--
    (i) The CAH 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 (d)(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) 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 CAH, but 
only if the waiver will not adversely affect the health and safety of 
the patients.
    (3) After consideration of State survey agency findings, CMS may 
waive specific provisions of the Life Safety Code that, if rigidly 
applied, would result in unreasonable hardship on the CAH, but only if 
the waiver does not adversely affect the health and safety of patients.
    (4) The CAH maintains written evidence of regular inspection and 
approval by State or local fire control agencies.
    (5) A CAH may install alcohol-based hand rub dispensers in its 
facility if the dispensers are installed in a manner that adequately 
protects against inappropriate access.
    (6) When a sprinkler system is shut down for more than 10 hours, the 
CAH must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (7) Buildings must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (i) The sill height requirement does not apply to newborn nurseries 
and rooms intended for occupancy for less than 24 hours.
    (ii) Special nursing care areas of new occupancies shall not exceed 
60 inches.
    (d) Standard: Building safety. Except as otherwise provided in this 
section, the CAH 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 CAH.
    (2) If application of the Health Care Facilities Code required under 
paragraph (e) of this section would result in unreasonable hardship for 
the CAH, 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/

[[Page 209]]

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]

[58 FR 30671, May 26, 1993, as amended at 62 FR 46036, 46037, Aug. 29, 
1997; 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR 
15239, Mar. 25, 2005; 71 FR 55341, Sept. 22, 2006; 77 FR 29076, May 16, 
2012; 81 FR 26901, May 4, 2016; 81 FR 64036, Sept. 16, 2016]



Sec. 485.625  Condition of participation: Emergency preparedness.

    The CAH must comply with all applicable Federal, State, and local 
emergency preparedness requirements. The CAH must develop and maintain a 
comprehensive emergency preparedness program, utilizing an all-hazards 
approach. The emergency preparedness plan must include, but not be 
limited to, the following elements:
    (a) Emergency plan. The CAH must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, 
persons at-risk; the type of services the CAH 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 CAH must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to--
    (i) Food, water, medical, and pharmaceutical supplies;
    (ii) Alternate sources of energy to maintain:
    (A) Temperatures to protect patient health and safety and for the 
safe and sanitary storage of provisions;
    (B) Emergency lighting;
    (C) Fire detection, extinguishing, and alarm systems; and
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
patients in the CAH's care during an emergency. If on-duty staff and 
sheltered patients are relocated during the emergency, the CAH must 
document the specific name and location of the receiving facility or 
other location.
    (3) Safe evacuation from the CAH, which includes consideration of 
care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s); and

[[Page 210]]

primary and alternate means of communication with external sources of 
assistance.
    (4) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves patient 
information, protects confidentiality of patient 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 role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (7) The development of arrangements with other CAHs or other 
providers to receive patients in the event of limitations or cessation 
of operations to maintain the continuity of services to CAH patients.
    (8) The role of the CAH 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.
    (c) Communication plan. The CAH 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) Patients' physicians.
    (iv) Other CAHs and hospitals.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) CAH's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
patients under the CAH'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 patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the CAH's occupancy, 
needs, and its ability to provide assistance, to the authority having 
jurisdiction or the Incident Command Center, or designee.
    (d) Training and testing. The CAH 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 CAH must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures, including prompt reporting and extinguishing of fires, 
protection, and where necessary, evacuation of patients, personnel, and 
guests, fire prevention, and cooperation with firefighting and disaster 
authorities, to all new and existing staff, individuals providing 
services under arrangement, and volunteers, consistent with their 
expected roles.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the CAH must conduct training on the updated 
policies and procedures.
    (2) Testing. The CAH must conduct exercises to test the emergency 
plan at

[[Page 211]]

least twice per year. The CAH 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 CAH experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CAH 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 annual additional exercise, 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 CAH's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CAH's emergency plan, as needed.
    (e) Emergency and standby power systems. The CAH must implement 
emergency and standby power systems based on the emergency plan set 
forth in paragraph (a) of this section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in 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), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The CAH must 
implement emergency power system inspection and testing requirements 
found in the Health Care Facilities Code, NFPA 110, and the Life Safety 
Code.
    (3) Emergency generator fuel. CAHs that maintain an onsite fuel 
source to power emergency generators must have a plan for how it will 
keep emergency power systems operational during the emergency, unless it 
evacuates.
    (f) Integrated healthcare systems. If a CAH 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 CAH may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of 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--
    (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.
    (g) The standards incorporated by reference in this section are 
approved

[[Page 212]]

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 obtain the material from the sources listed below. 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, Health Care Facilities Code, 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (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.
    (xii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

[81 FR 64036, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016, as amended at 
84 FR 51826, Sept. 30, 2019]



Sec. 485.627  Condition of participation: Organizational structure.

    (a) Standard: Governing body or responsible individual. The CAH has 
a governing body or an individual that assumes full legal responsibility 
for determining, implementing and monitoring policies governing the 
CAH's total operation and for ensuring that those policies are 
administered so as to provide quality health care in a safe environment.
    (b) Standard: Disclosure. The CAH discloses the names and addresses 
of--
    (1) The person principally responsible for the operation of the CAH; 
and
    (2) The person responsible for medical direction.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 84 
FR 51827, Sept. 30, 2019]



Sec. 485.631  Condition of participation: Staffing and staff responsibilities.

    (a) Standard: Staffing--(1) The CAH has a professional health care 
staff that includes one or more doctors of medicine or osteopathy, and 
may include one or more physician assistants, nurse practitioners, or 
clinical nurse specialists.
    (2) Any ancillary personnel are supervised by the professional 
staff.
    (3) The staff is sufficient to provide the services essential to the 
operation of the CAH.
    (4) A doctor of medicine or osteopathy, nurse practitioner, clinical 
nurse specialist, or physician assistant is available to furnish patient 
care services at all times the CAH operates.
    (5) A registered nurse, clinical nurse specialist, or licensed 
practical nurse is on duty whenever the CAH has one or more inpatients.
    (b) Standard: Responsibilities of the doctor of medicine or 
osteopathy. (1) The doctor of medicine or osteopathy--
    (i) Provides medical direction for the CAH's health care activities 
and consultation for, and medical supervision of, the health care staff;
    (ii) In conjunction with the physician assistant and/or nurse 
practitioner member(s), participates in developing, executing, and 
periodically reviewing the CAH's written policies governing the services 
it furnishes.

[[Page 213]]

    (iii) In conjunction with the physician assistant and/or nurse 
practitioner members, periodically reviews the CAH's patient records, 
provides medical orders, and provides medical care services to the 
patients of the CAH; and
    (iv) Periodically reviews and signs the records of all inpatients 
cared for by nurse practitioners, clinical nurse specialists, certified 
nurse midwives, or physician assistants.
    (v) Periodically reviews and signs a sample of outpatient records of 
patients cared for by nurse practitioners, clinical nurse specialists, 
certified nurse midwives, or physician assistants only to the extent 
required under State law where State law requires record reviews or co-
signatures, or both, by a collaborating physician.
    (2) A doctor of medicine or osteopathy is present for sufficient 
periods of time to provide medical direction, consultation, and 
supervision for the services provided in the CAH, and is available 
through direct radio or telephone communication or electronic 
communication for consultation, assistance with medical emergencies, or 
patient referral.
    (c) Standard: Physician assistant, nurse practitioner, and clinical 
nurse specialist responsibilities. (1) The physician assistant, the 
nurse practitioner, or clinical nurse specialist members of the CAH's 
staff--
    (i) Participate in the development, execution and periodic review of 
the written policies governing the services the CAH furnishes; and
    (ii) Participate with a doctor of medicine or osteopathy in a 
periodic review of the patients' health records.
    (2) The physician assistant, nurse practitioner, or clinical nurse 
specialist performs the following functions to the extent they are not 
being performed by a doctor of medicine or osteopathy:
    (i) Provides services in accordance with the CAH's policies.
    (ii) Arranges for, or refers patients to, needed services that 
cannot be furnished at the CAH, and assures that adequate patient health 
records are maintained and transferred as required when patients are 
referred.
    (3) Whenever a patient is admitted to the CAH by a nurse 
practitioner, physician assistant, or clinical nurse specialist, a 
doctor of medicine or osteopathy on the staff of the CAH is notified of 
the admission.
    (d) Standard: Periodic review of clinical privileges and 
performance. The CAH requires that--
    (1) The quality and appropriateness of the diagnosis and treatment 
furnished by nurse practitioners, clinical nurse specialist, and 
physician assistants at the CAH are evaluated by a member of the CAH 
staff who is a doctor of medicine or osteopathy or by another doctor of 
medicine or osteopathy under contract with the CAH.
    (2) The quality and appropriateness of the diagnosis and treatment 
furnished by doctors of medicine or osteopathy at the CAH are evaluated 
by--
    (i) One hospital that is a member of the network, when applicable;
    (ii) One Quality Improvement Organization (QIO) or equivalent 
entity;
    (iii) One other appropriate and qualified entity identified in the 
State rural health care plan;
    (iv) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patient under an agreement 
between the CAH and a distant-site hospital, the distant-site hospital; 
or
    (v) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site telemedicine entity, one of 
the entities listed in paragraphs (d)(2)(i) through (iii) of this 
section.
    (3) The CAH staff consider the findings of the evaluation and make 
the necessary changes as specified in paragraphs (b) through (d) of this 
section.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 70 
FR 68728, Nov. 10, 2005; 79 FR 27155, May 12, 2014; 84 FR 51827, Sept. 
30, 2019]



Sec. 485.635  Condition of participation: Provision of services.

    (a) Standard: Patient care policies. (1) The CAH's health care 
services are furnished in accordance with appropriate written policies 
that are consistent with applicable State law.

[[Page 214]]

    (2) The policies are developed with the advice of members of the 
CAH's professional healthcare staff, including one or more doctors of 
medicine or osteopathy and one or more physician assistants, nurse 
practitioners, or clinical nurse specialists, if they are on staff under 
the provisions of Sec. 485.631(a)(1).
    (3) The policies include the following:
    (i) A description of the services the CAH furnishes, including those 
furnished through agreement or arrangement.
    (ii) Policies and procedures for emergency medical services.
    (iii) Guidelines for the medical management of health problems that 
include the conditions requiring medical consultation and/or patient 
referral, the maintenance of health care records, and procedures for the 
periodic review and evaluation of the services furnished by the CAH.
    (iv) Rules for the storage, handling, dispensation, and 
administration of drugs and biologicals. These rules must provide that 
there is a drug storage area that is administered in accordance with 
accepted professional principles, that current and accurate records are 
kept of the receipt and disposition of all scheduled drugs, and that 
outdated, mislabeled, or otherwise unusable drugs are not available for 
patient use.
    (v) Procedures for reporting adverse drug reactions and errors in 
the administration of drugs.
    (vi) Procedures that ensure that the nutritional needs of inpatients 
are met in accordance with recognized dietary practices. All patient 
diets, including therapeutic diets, must be ordered by the practitioner 
responsible for the care of the patients or by a qualified dietitian or 
qualified nutrition professional as authorized by the medical staff in 
accordance with State law governing dietitians and nutrition 
professionals and that the requirement of Sec. 483.25(i) of this 
chapter is met with respect to inpatients receiving post CAH SNF care.
    (vii) [Reserved]
    (viii) Policies and procedures that address the post-acute care 
needs of patients receiving CAH services.
    (4) These policies are reviewed at least biennially by the group of 
professional personnel required under paragraph (a)(2) of this section 
and updated as necessary by the CAH.
    (b) Standard: Patient services--(1) General: (i) The CAH provides 
those diagnostic and therapeutic services and supplies that are commonly 
furnished in a physician's office or at another entry point into the 
health care delivery system, such as a low intensity hospital outpatient 
department or emergency department. These CAH services include medical 
history, physical examination, specimen collection, assessment of health 
status, and treatment for a variety of medical conditions.
    (ii) The CAH furnishes acute care inpatient services.
    (2) Laboratory services. The CAH provides basic laboratory services 
essential to the immediate diagnosis and treatment of the patient that 
meet the standards imposed under section 353 of the Public Health 
Service Act (42 U.S.C. 236a). (See the laboratory requirements specified 
in part 493 of this chapter.) The services provided include the 
following:
    (i) Chemical examination of urine by stick or tablet method or both 
(including urine ketones).
    (ii) Hemoglobin or hematocrit.
    (iii) Blood glucose.
    (iv) Examination of stool specimens for occult blood.
    (v) Pregnancy tests.
    (vi) Primary culturing for transmittal to a certified laboratory.
    (3) Radiology services. Radiology services furnished by the CAH are 
provided by personnel qualified under State law, and do not expose CAH 
patients or personnel to radiation hazards.
    (4) Emergency procedures. In accordance with requirements of Sec. 
485.618, the CAH provides medical services as a first response to common 
life-threatening injuries and acute illness.
    (c) Standard: Services provided through agreements or arrangements. 
(1) The CAH has agreements or arrangements (as appropriate) with one or 
more providers or suppliers participating under Medicare to furnish 
other services to its patients, including--
    (i) Services of doctors of medicine or osteopathy;

[[Page 215]]

    (ii) Additional or specialized diagnostic and clinical laboratory 
services that are not available at the CAH; and
    (iii) Food and other services to meet inpatients' nutritional needs 
to the extent these services are not provided directly by the CAH.
    (2) If the agreements or arrangements are not in writing, the CAH is 
able to present evidence that patients referred by the CAH are being 
accepted and treated.
    (3) The CAH maintains a list of all services furnished under 
arrangements or agreements. The list describes the nature and scope of 
the services provided.
    (4) The person principally responsible for the operation of the CAH 
under Sec. 485.627(b)(2) of this chapter is also responsible for the 
following:
    (i) Services furnished in the CAH whether or not they are furnished 
under arrangements or agreements.
    (ii) Ensuring that a contractor of services (including one for 
shared services and joint ventures) furnishes services that enable the 
CAH to comply with all applicable conditions of participation and 
standards for the contracted services.
    (5) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site telemedicine entity, the 
distant-site telemedicine entity is not required to be a Medicare-
participating provider or supplier.
    (d) Standard: Nursing services. Nursing services must meet the needs 
of patients.
    (1) A registered nurse must provide (or assign to other personnel) 
the nursing care of each patient, including patients at a SNF level of 
care in a swing-bed CAH. The care must be provided in accordance with 
the patient's needs and the specialized qualifications and competence of 
the staff available.
    (2) A registered nurse or, where permitted by State law, a physician 
assistant, must supervise and evaluate the nursing care for each 
patient, including patients at a SNF level of care in a swing-bed CAH.
    (3) All drugs, biologicals, and intravenous medications must be 
administered by or under the supervision of a registered nurse, a doctor 
of medicine or osteopathy, or, where permitted by State law, a physician 
assistant, in accordance with written and signed orders, accepted 
standards of practice, and Federal and State laws.
    (4) A nursing care plan must be developed and kept current for each 
inpatient.
    (e) Standard: Rehabilitation Therapy Services. Physical therapy, 
occupational therapy, and speech-language pathology services furnished 
at the CAH, if provided, are provided by staff qualified under State 
law, and consistent with the requirements for therapy services in Sec. 
409.17 of this subpart.
    (f) Standard: Patient visitation rights. A CAH must have written 
policies and procedures regarding the visitation rights of patients, 
including those setting forth any clinically necessary or reasonable 
restriction or limitation that the CAH may need to place on such rights 
and the reasons for the clinical restriction or limitation. A CAH must 
meet the following requirements:
    (1) Inform each patient (or support person, where appropriate) of 
his or her visitation rights, including any clinical restriction or 
limitation on such rights, in advance of furnishing patient care 
whenever possible.
    (2) Inform each patient (or support person, where appropriate) of 
the right, subject to his or her consent, to receive the visitors whom 
he or she designates, including, but not limited to, a spouse, a 
domestic partner (including a same-sex domestic partner), another family 
member, or a friend, and his or her right to withdraw or deny such 
consent at any time.
    (3) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, gender 
identity, sexual orientation, or disability.

[[Page 216]]

    (4) Ensure that all visitors enjoy full and equal visitation 
privileges consistent with patient preferences.

[58 FR 30671, May 26, 1993; 58 FR 49935, Sept. 24, 1993, as amended at 
59 FR 45403, Sept. 1, 1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408, 
Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 75 FR 70844, Nov. 19, 2010; 
76 FR 25564, May 5, 2011; 77 FR 29076, May 16, 2012; 78 FR 50970, Aug. 
19, 2013; 79 FR 27156, May 12, 2014; 81 FR 68871, Oct. 4, 2016; 82 FR 
32260, July 13, 2017; 84 FR 51827, 51883, Sept. 30, 2019]



Sec. 485.638  Conditions of participation: Clinical records.

    (a) Standard: Records system--(1) The CAH maintains a clinical 
records system in accordance with written policies and procedures.
    (2) The records are legible, complete, accurately documented, 
readily accessible, and systematically organized.
    (3) A designated member of the professional staff is responsible for 
maintaining the records and for ensuring that they are completely and 
accurately documented, readily accessible, and systematically organized.
    (4) For each patient receiving health care services, the CAH 
maintains a record that includes, as applicable--
    (i) Identification and social data, evidence of properly executed 
informed consent forms, pertinent medical history, assessment of the 
health status and health care needs of the patient, and a brief summary 
of the episode, disposition, and instructions to the patient;
    (ii) Reports of physical examinations, diagnostic and laboratory 
test results, including clinical laboratory services, and consultative 
findings;
    (iii) All orders of doctors of medicine or osteopathy or other 
practitioners, reports of treatments and medications, nursing notes and 
documentation of complications, and other pertinent information 
necessary to monitor the patient's progress, such as temperature 
graphics, progress notes describing the patient's response to treatment; 
and
    (iv) Dated signatures of the doctor of medicine or osteopathy or 
other health care professional.
    (b) Standard: Protection of record information. (1) The CAH 
maintains the confidentiality of record information and provides 
safeguards against loss, destruction, or unauthorized use.
    (2) Written policies and procedures govern the use and removal of 
records from the CAH and the conditions for the release of information.
    (3) The patient's written consent is required for release of 
information not required by law.
    (c) Standard: Retention of records. The records are retained for at 
least 6 years from date of last entry, and longer if required by State 
statute, or if the records may be needed in any pending proceeding.
    (d) Standard: Electronic notifications. If the CAH utilizes an 
electronic medical records system or other electronic administrative 
system, which is conformant with the content exchange standard at 45 CFR 
170.205(d)(2), then the CAH must demonstrate that--
    (1) The system's notification capacity is fully operational and the 
CAH uses it in accordance with all State and Federal statutes and 
regulations applicable to the CAH's exchange of patient health 
information.
    (2) The system sends notifications that must include at least 
patient name, treating practitioner name, and sending institution name.
    (3) To the extent permissible under applicable federal and state law 
and regulations, and not inconsistent with the patient's expressed 
privacy preferences, the system sends notifications directly, or through 
an intermediary that facilitates exchange of health information, at the 
time of:
    (i) The patient's registration in the CAH's emergency department (if 
applicable).
    (ii) The patient's admission to the CAH's inpatient services (if 
applicable).
    (4) To the extent permissible under applicable federal and state law 
and regulations, and not inconsistent with the patient's expressed 
privacy preferences, the system sends notifications directly, or through 
an intermediary that facilitates exchange of health information, either 
immediately prior to, or at the time of:
    (i) The patient's discharge or transfer from the CAH's emergency 
department (if applicable).
    (ii) The patient's discharge or transfer from the CAH's inpatient 
services (if applicable).

[[Page 217]]

    (5) The CAH has made a reasonable effort to ensure that the system 
sends the notifications to all applicable post-acute care services 
providers and suppliers, as well as to any of the following 
practitioners and entities, which need to receive notification of the 
patient's status for treatment, care coordination, or quality 
improvement purposes:
    (i) The patient's established primary care practitioner;
    (ii) The patient's established primary care practice group or 
entity; or
    (iii) Other practitioner, or other practice group or entity, 
identified by the patient as the practitioner, or practice group or 
entity, primarily responsible for his or her care.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 85 
FR 25638, May 1, 2020]



Sec. 485.639  Condition of participation: Surgical services.

    If a CAH provides surgical services, surgical procedures must be 
performed in a safe manner by qualified practitioners who have been 
granted clinical privileges by the governing body, or responsible 
individual, of the CAH in accordance with the designation requirements 
under paragraph (a) of this section.
    (a) Designation of qualified practitioners. The CAH designates the 
practitioners who are allowed to perform surgery for CAH patients, in 
accordance with its approved policies and procedures, and with State 
scope of practice laws. Surgery is performed only by--
    (1) A doctor of medicine or osteopathy, including an osteopathic 
practitioner recognized under section 1101(a)(7) of the Act;
    (2) A doctor of dental surgery or dental medicine; or
    (3) A doctor of podiatric medicine.
    (b) Anesthetic risk and evaluation. (1) A qualified practitioner, as 
specified in paragraph (a) of this section, must examine the patient 
immediately before surgery to evaluate the risk of the procedure to be 
performed.
    (2) A qualified practitioner, as specified in paragraph (c) of this 
section, must examine each patient before surgery to evaluate the risk 
of anesthesia.
    (3) Before discharge from the CAH, each patient must be evaluated 
for proper anesthesia recovery by a qualified practitioner, as specified 
in paragraph (c) of this section.
    (c) Administration of anesthesia. The CAH designates the person who 
is allowed to administer anesthesia to CAH patients in accordance with 
its approved policies and procedures and with State scope-of-practice 
laws.
    (1) Anesthesia must be administered by only--
    (i) A qualified anesthesiologist;
    (ii) A doctor of medicine or osteopathy other than an 
anesthesiologist; including an osteopathic practitioner recognized under 
section 1101(a)(7) of the Act;
    (iii) A doctor of dental surgery or dental medicine;
    (iv) A doctor of podiatric medicine;
    (v) A certified registered nurse anesthetist (CRNA), as defined in 
Sec. 410.69(b) of this chapter;
    (vi) An anesthesiologist's assistant, as defined in Sec. 410.69(b) 
of this chapter; or
    (vii) A supervised trainee in an approved educational program, as 
described in Sec. 413.85 or Sec. Sec. 413.76 through 413.83 of this 
chapter.
    (2) In those cases in which a CRNA administers the anesthesia, the 
anesthetist must be under the supervision of the operating practitioner 
except as provided in paragraph (e) of this section. An 
anesthesiologist's assistant who administers anesthesia must be under 
the supervision of an anesthesiologist.
    (d) Discharge. All patients are discharged in the company of a 
responsible adult, except those exempted by the practitioner who 
performed the surgical procedure.
    (e) Standard: State exemption. (1) A CAH may be exempted from the 
requirement for physician supervision of CRNAs as described in paragraph 
(c)(2) of this section, if the State in which the CAH is located submits 
a letter to CMS signed by the Governor, following consultation with the 
State's Boards of Medicine and Nursing, requesting exemption from 
physician supervision for CRNAs. The letter from the Governor

[[Page 218]]

must attest that he or she has consulted with the State Boards of 
Medicine and Nursing about issues related to access to and the quality 
of anesthesia services in the State and has concluded that it is in the 
best interests of the State's citizens to opt-out of the current 
physician supervision requirement, and that the opt-out is consistent 
with State law.
    (2) The request for exemption and recognition of State laws and the 
withdrawal of the request may be submitted at any time, and are 
effective upon submission.

[60 FR 45851, Sept. 1, 1995, as amended at 62 FR 46037, Aug. 29, 1997; 
66 FR 39938, Aug. 1, 2001; 66 FR 56769, Nov. 13, 2001; 77 FR 29076, May 
16, 2012; 85 FR 72910, Nov. 16, 2020]



Sec. 485.640  Condition of participation: Infection prevention and
control and antibiotic stewardship programs.

    The CAH must have active facility-wide programs, for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases and for the optimization of antibiotic use through stewardship. 
The programs must demonstrate adherence to nationally recognized 
infection prevention and control guidelines, as well as to best 
practices for improving antibiotic use where applicable, and for 
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and 
antibiotic use issues identified in the programs must be addressed in 
coordination with the facility-wide quality assessment and performance 
improvement (QAPI) program.
    (a) Standard: Infection prevention and control program organization 
and policies. The CAH must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, experience, or certification in infection 
prevention and control, is appointed by the governing body, or 
responsible individual, as the infection preventionist(s)/infection 
control professional(s) responsible for the infection prevention and 
control program and that the appointment is based on the recommendations 
of medical staff leadership and nursing leadership;
    (2) The infection prevention and control program, as documented in 
its policies and procedures, employs methods for preventing and 
controlling the transmission of infections within the CAH and between 
the CAH and other healthcare settings;
    (3) The infection prevention and control includes surveillance, 
prevention, and control of HAIs, including maintaining a clean and 
sanitary environment to avoid sources and transmission of infection, and 
that the program also addresses any infection control issues identified 
by public health authorities; and
    (4) The infection prevention and control program reflects the scope 
and complexity of the CAH services provided.
    (b) Standard: Antibiotic stewardship program organization and 
policies. The CAH must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, or experience in infectious diseases and/or 
antibiotic stewardship, is appointed by the governing body, or 
responsible individual, as the leader(s) of the antibiotic stewardship 
program and that the appointment is based on the recommendations of 
medical staff leadership and pharmacy leadership;
    (2) The facility-wide antibiotic stewardship program:
    (i) Demonstrates coordination among all components of the CAH 
responsible for antibiotic use and resistance, including, but not 
limited to, the infection prevention and control program, the QAPI 
program, the medical staff, nursing services, and pharmacy services;
    (ii) Documents the evidence-based use of antibiotics in all 
departments and services of the CAH; and
    (iii) Documents any improvements, including sustained improvements, 
in proper antibiotic use;
    (3) The antibiotic stewardship program adheres to nationally 
recognized guidelines, as well as best practices, for improving 
antibiotic use; and
    (4) The antibiotic stewardship program reflects the scope and 
complexity of the CAH services provided.

[[Page 219]]

    (c) Standard: Leadership responsibilities. (1) The governing body, 
or responsible individual, must ensure all of the following:
    (i) Systems are in place and operational for the tracking of all 
infection surveillance, prevention and control, and antibiotic use 
activities, in order to demonstrate the implementation, success, and 
sustainability of such activities.
    (ii) All HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed in 
collaboration with the CAH's QAPI leadership.
    (2) The infection prevention and control professional(s) is 
responsible for:
    (i) The development and implementation of facility-wide infection 
surveillance, prevention, and control policies and procedures that 
adhere to nationally recognized guidelines.
    (ii) All documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities.
    (iii) Communication and collaboration with the CAH's QAPI program on 
infection prevention and control issues.
    (iv) Competency-based training and education of CAH personnel and 
staff, including medical staff, and, as applicable, personnel providing 
contracted services in the CAH, on the practical applications of 
infection prevention and control guidelines, policies and procedures.
    (v) The prevention and control of HAIs, including auditing of 
adherence to infection prevention and control policies and procedures by 
CAH personnel.
    (vi) Communication and collaboration with the antibiotic stewardship 
program.
    (3) The leader(s) of the antibiotic stewardship program is 
responsible for:
    (i) The development and implementation of a facility-wide antibiotic 
stewardship program, based on nationally recognized guidelines, to 
monitor and improve the use of antibiotics.
    (ii) All documentation, written or electronic, of antibiotic 
stewardship program activities.
    (iii) Communication and collaboration with medical staff, nursing, 
and pharmacy leadership, as well as the CAH's infection prevention and 
control and QAPI programs, on antibiotic use issues.
    (iv) Competency-based training and education of CAH personnel and 
staff, including medical staff, and, as applicable, personnel providing 
contracted services in the CAHs, on the practical applications of 
antibiotic stewardship guidelines, policies, and procedures.
    (d) COVID-19 reporting. During the Public Health Emergency, as 
defined in Sec. [thinsp]400.200 of this chapter, the CAH must report 
information in accordance with a frequency as specified by the Secretary 
on COVID-19 in a standardized format specified by the Secretary. This 
report must include, but not be limited to, the following data elements:
    (1) The CAH's current inventory supplies of any COVID-19-related 
therapeutics that have been distributed and delivered to the CAH under 
the authority and direction of the Secretary; and
    (2) The CAH's current usage rate for any COVID-19-related 
therapeutics that have been distributed and delivered to the CAH under 
the authority and direction of the Secretary.
    (e) Standard: Reporting of Acute Respiratory Illness, including 
Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute 
Respiratory Infection. During the Public Health Emergency, as defined in 
Sec. 400.200 of this chapter, the CAH must report information, in 
accordance with a frequency as specified by the Secretary, on Acute 
Respiratory Illness (including, but not limited to, Seasonal Influenza 
Virus, Influenza-like Illness, and Severe Acute Respiratory Infection) 
in a standardized format specified by the Secretary.

[84 FR 51827, Sept. 30, 2019, as amended at 85 FR 54873, Sept. 2, 2020; 
85 FR 86304, Dec. 29, 2020]

    Editorial Note: At 85 FR 86304, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.

[[Page 220]]



Sec. 485.641  Condition of participation: Quality assessment and
performance improvement program.

    The CAH must develop, implement, and maintain an effective, ongoing, 
CAH-wide, data-driven quality assessment and performance improvement 
(QAPI) program. The CAH must maintain and demonstrate evidence of the 
effectiveness of its QAPI program.
    (a) Definitions. For the purposes of this section--
    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury or the risk 
thereof.
    Error means the failure of a planned action to be completed as 
intended or the use of a wrong plan to achieve an aim. Errors can 
include problems in practice, products, procedures, and systems; and
    Medical error means an error that occurs in the delivery of 
healthcare services.
    (b) Standard: QAPI Program Design and scope. The CAH's QAPI program 
must:
    (1) Be appropriate for the complexity of the CAH's organization and 
services provided.
    (2) Be ongoing and comprehensive.
    (3) Involve all departments of the CAH and services (including those 
services furnished under contract or arrangement).
    (4) Use objective measures to evaluate its organizational processes, 
functions and services.
    (5) Address outcome indicators related to improved health outcomes 
and the prevention and reduction of medical errors, adverse events, CAH-
acquired conditions, and transitions of care, including readmissions.
    (c) Standard: Governance and leadership. The CAH's governing body or 
responsible individual is ultimately responsible for the CAH's QAPI 
program and is responsible and accountable for ensuring that the QAPI 
program meets the requirements of paragraph (b) of this section.
    (d) Standard: Program activities. For each of the areas listed in 
paragraph (b) of this section, the CAH must:
    (1) Focus on measures related to improved health outcomes that are 
shown to be predictive of desired patient outcomes.
    (2) Use the measures to analyze and track its performance.
    (3) Set priorities for performance improvement, considering either 
high-volume, high-risk services, or problem-prone areas.
    (e) Standard: Program data collection and analysis. The program must 
incorporate quality indicator data including patient care data, and 
other relevant data, in order to achieve the goals of the QAPI program.

[84 FR 51828, Sept. 30, 2019]



Sec. 485.642  Condition of participation: Discharge planning.

    A Critical Access Hospital (CAH) must have an effective discharge 
planning process that focuses on the patient's goals and treatment 
preferences and includes the patient and his or her caregivers/support 
person(s) as active partners in the discharge planning for post-
discharge care. The discharge planning process and the discharge plan 
must be consistent with the patient's goals for care and his or her 
treatment preferences, ensure an effective transition of the patient 
from the CAH to post-discharge care, and reduce the factors leading to 
preventable CAH and hospital readmissions.
    (a) Standard: Discharge planning process. The CAH's discharge 
planning process must identify, at an early stage of hospitalization, 
those patients who are likely to suffer adverse health consequences upon 
discharge in the absence of adequate discharge planning and must provide 
a discharge planning evaluation for those patients so identified as well 
as for other patients upon the request of the patient, patient's 
representative, or patient's physician.
    (1) Any discharge planning evaluation must be made on a timely basis 
to ensure that appropriate arrangements for post-CAH care will be made 
before discharge and to avoid unnecessary delays in discharge.
    (2) A discharge planning evaluation must include an evaluation of a 
patient's likely need for appropriate post-CAH services, including, but 
not limited to, hospice care services, post-CAH extended care services, 
home health services, and non-health care services

[[Page 221]]

and community based care providers, and must also include a 
determination of the availability of the appropriate services as well as 
of the patient's access to those services.
    (3) The discharge planning evaluation must be included in the 
patient's medical record for use in establishing an appropriate 
discharge plan and the results of the evaluation must be discussed with 
the patient (or the patient's representative).
    (4) Upon the request of a patient's physician, the CAH must arrange 
for the development and initial implementation of a discharge plan for 
the patient.
    (5) Any discharge planning evaluation or discharge plan required 
under this paragraph must be developed by, or under the supervision of, 
a registered nurse, social worker, or other appropriately qualified 
personnel.
    (6) The CAH's discharge planning process must require regular re-
evaluation of the patient's condition to identify changes that require 
modification of the discharge plan. The discharge plan must be updated, 
as needed, to reflect these changes.
    (7) The CAH must assess its discharge planning process on a regular 
basis. The assessment must include ongoing, periodic review of a 
representative sample of discharge plans, including those patients who 
were readmitted within 30 days of a previous admission, to ensure that 
the plans are responsive to patient post-discharge needs.
    (8) The CAH must assist patients, their families, or the patient's 
representative in selecting a post-acute care provider by using and 
sharing data that includes, but is not limited to, HHA, SNF, IRF, or 
LTCH data on quality measures and data on resource use measures. The CAH 
must ensure that the post-acute care data on quality measures and data 
on resource use measures is relevant and applicable to the patient's 
goals of care and treatment preferences.
    (b) Standard: Discharge of the patient and provision and 
transmission of the patient's necessary medical information. The CAH 
must discharge the patient, and also transfer or refer the patient where 
applicable, along with all necessary medical information pertaining to 
the patient's current course of illness and treatment, post-discharge 
goals of care, and treatment preferences, at the time of discharge, to 
the appropriate post-acute care service providers and suppliers, 
facilities, agencies, and other outpatient service providers and 
practitioners responsible for the patient's follow-up or ancillary care.

[84 FR 51883, Sept. 30, 2019]



Sec. 485.643  Condition of participation: Organ, tissue, and eye
procurement.

    The CAH must have and implement written protocols that:
    (a) Incorporate an agreement with an OPO designated under part 486 
of this chapter, under which it must notify, in a timely manner, the OPO 
or a third party designated by the OPO of individuals whose death is 
imminent or who have died in the CAH. The OPO determines medical 
suitability for organ donation and, in the absence of alternative 
arrangements by the CAH, the OPO determines medical suitability for 
tissue and eye donation, using the definition of potential tissue and 
eye donor and the notification protocol developed in consultation with 
the tissue and eye banks identified by the CAH for this purpose;
    (b) Incorporate an agreement with at least one tissue bank and at 
least one eye bank to cooperate in the retrieval, processing, 
preservation, storage and distribution of tissues and eyes, as may be 
appropriate to assure that all usable tissues and eyes are obtained from 
potential donors, insofar as such an agreement does not interfere with 
organ procurement;
    (c) Ensure, in collaboration with the designated OPO, that the 
family of each potential donor is informed of its option to either 
donate or not donate organs, tissues, or eyes. The individual designated 
by the CAH to initiate the request to the family must be a designated 
requestor. A designated requestor is an individual who has completed a 
course offered or approved by the OPO and designed in conjunction with 
the tissue and eye bank community in the methodology for approaching 
potential donor families and requesting organ or tissue donation;

[[Page 222]]

    (d) Encourage discretion and sensitivity with respect to the 
circumstances, views, and beliefs of the families of potential donors;
    (e) Ensure that the CAH works cooperatively with the designated OPO, 
tissue bank and eye bank in educating staff on donation issues, 
reviewing death records to improve identification of potential donors, 
and maintaining potential donors while necessary testing and placement 
of potential donated organs, tissues, and eyes take place.
    (f) For purposes of these standards, the term ``organ'' means a 
human kidney, liver, heart, lung, pancreas, or intestines (or 
multivisceral organs).

[65 FR 47110, Aug. 1, 2000, as amended at 66 FR 39938, Aug. 1, 2001]



Sec. 485.645  Special requirements for CAH providers of long-term
care services (``swing-beds'')

    A CAH must meet the following requirements in order to be granted an 
approval from CMS to provide post-CAH SNF care, as specified in Sec. 
409.30 of this chapter, and to be paid for SNF-level services, in 
accordance with paragraph (c) of this section.
    (a) Eligibility. A CAH must meet the following eligibility 
requirements:
    (1) The facility has been certified as a CAH by CMS under Sec. 
485.606(b) of this subpart; and
    (2) The facility provides not more than 25 inpatient beds. Any bed 
of a unit of the facility that is licensed as a distinct-part SNF at the 
time the facility applies to the State for designation as a CAH is not 
counted under paragraph (a) of this section.
    (b) Facilities participating as rural primary care hospitals (RPCHs) 
on September 30, 1997. These facilities must meet the following 
requirements:
    (1) Notwithstanding paragraph (a) of this section, a CAH that 
participated in Medicare as a RPCH on September 30, 1997, and on that 
date had in effect an approval from CMS to use its inpatient facilities 
to provide post-hospital SNF care may continue in that status under the 
same terms, conditions and limitations that were applicable at the time 
those approvals were granted.
    (2) A CAH that was granted swing-bed approval under paragraph (b)(1) 
of this section may request that its application to be a CAH and swing-
bed provider be reevaluated under paragraph (a) of this section. If this 
request is approved, the approval is effective not earlier than October 
1, 1997. As of the date of approval, the CAH no longer has any status 
under paragraph (b)(1) of this section and may not request reinstatement 
under paragraph (b)(1) of this section.
    (c) Payment. Payment for inpatient RPCH services to a CAH that has 
qualified as a CAH under the provisions in paragraph (a) of this section 
is made in accordance with Sec. 413.70 of this chapter. Payment for 
post-hospital SNF-level of care services is made in accordance with the 
payment provisions in Sec. 413.114 of this chapter.
    (d) SNF services. The CAH is substantially in compliance with the 
following SNF requirements contained in subpart B of part 483 of this 
chapter:
    (1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii), 
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17), 
(g)(18) introductory text, and (h) of this chapter).
    (2) Admission, transfer, and discharge rights (Sec. 483.5 
definition of transfer & discharge, Sec. 483.15(c)(1), (c)(2), (c)(3), 
(c)(4), (c)(5), (c)(7), (c)(8), and (c)(9) of this chapter).
    (3) Freedom from abuse, neglect and exploitation (Sec. 
483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), 
(c)(1), (c)(2), (c)(3), and (c)(4) of this chapter).
    (4) Social services (Sec. 483.40(d) of this chapter).
    (5) Comprehensive assessment, comprehensive care plan, and discharge 
planning (Sec. 483.20(b), and Sec. 483.21(b) and (c)(2) of this 
chapter), except that the CAH is not required to use the resident 
assessment instrument (RAI) specified by the State that is required 
under Sec. 483.20(b), or to comply with the requirements for frequency, 
scope, and number of assessments prescribed in Sec. 413.343(b) of this 
chapter).
    (6) Specialized rehabilitative services (Sec. 483.65 of this 
chapter).
    (7) Dental services (Sec. 483.55(a)(2), (3), (4), and (5) and (b) 
of this chapter).

[[Page 223]]

    (8) Nutrition (Sec. 483.25(g)(1) and (g)(2) of this chapter).

[63 FR 26359, May 12, 1998, as amended at 64 FR 41544, July 30, 1999; 67 
FR 50120, Aug. 1, 2002; 69 FR 49272, Aug. 11, 2004; 81 FR 68871, Oct. 4, 
2016; 82 FR 32260, July 13, 2017; 84 FR 51828, Sept. 30, 2019]



Sec. 485.647  Condition of participation: psychiatric and rehabilitation
distinct part units.

    (a) Conditions. (1) If a CAH provides inpatient psychiatric services 
in a distinct part unit, the services furnished by the distinct part 
unit must comply with the hospital requirements specified in subparts A, 
B, C, and D of part 482 of this subchapter, the common requirements of 
Sec. 412.25(a)(2) through (f) of part 412 of this chapter for hospital 
units excluded from the prospective payment systems, and the additional 
requirements of Sec. 412.27 of part 412 of this chapter for excluded 
psychiatric units.
    (2) If a CAH provides inpatient rehabilitation services in a 
distinct part unit, the services furnished by the distinct part unit 
must comply with the hospital requirements specified in subparts A, B, 
C, and D of part 482 of this subchapter, the common requirements of 
Sec. 412.25(a)(2) through (f) of part 412 of this chapter for hospital 
units excluded from the prospective payments systems, and the additional 
requirements of Sec. Sec. 412.29 and Sec. 412.30 of part 412 of this 
chapter related specifically to rehabilitation units.
    (b) Eligibility requirements. (1) To be eligible to receive Medicare 
payments for psychiatric or rehabilitation services as a distinct part 
unit, the facility provides no more than 10 beds in the distinct part 
unit.
    (2) The beds in the distinct part are excluded from the 25 
inpatient-bed count limit specified in Sec. 485.620(a).
    (3) The average annual 96-hour length of stay requirement specified 
under Sec. 485.620(b) does not apply to the 10 beds in the distinct 
part units specified in paragraph (b)(1) of this section, and admissions 
and days of inpatient care in the distinct part units are not taken into 
account in determining the CAH's compliance with the limits on the 
number of beds and length of stay in Sec. 485.620.

[69 FR 49272, Aug. 11, 2004]

Subpart G [Reserved]



   Subpart H_Conditions of Participation for Clinics, Rehabilitation 
Agencies, and Public Health Agencies as Providers of Outpatient Physical 
             Therapy and Speech-Language Pathology Services



Sec. 485.701  Basis and scope.

    This subpart implements section 1861(p)(4) of the Act, which--
    (a) Defines outpatient physical therapy and speech pathology 
services;
    (b) Imposes requirements with respect to adequate program, 
facilities, policies, staffing, and clinical records; and
    (c) Authorizes the Secretary to establish by regulation other health 
and safety requirements.

[60 FR 2327, Jan. 9, 1995]



Sec. 485.703  Definitions.

    Clinic. A facility that is established primarily to furnish 
outpatient physician services and that meets the following tests of 
physician involvement:
    (1) The medical services are furnished by a group of three or more 
physicians practicing medicine together.
    (2) A physician is present during all hours of operation of the 
clinic to furnish medical services, as distinguished from purely 
administrative services.
    Extension location. A location or site from which a rehabilitation 
agency provides services within a portion of the total geographic area 
served by the primary site. The extension location is part of the 
rehabilitation agency. The extension location should be located 
sufficiently close to share administration, supervision, and services in 
a manner that renders it unnecessary for the extension location to 
independently meet the conditions of participation as a rehabilitation 
agency.
    Organization. A clinic, rehabilitation agency, or public health 
agency.

[[Page 224]]

    Public health agency. An official agency established by a State or 
local government, the primary function of which is to maintain the 
health of the population served by performing environmental health 
services, preventive medical services, and in certain cases, therapeutic 
services.
    Rehabilitation agency. An agency that--
    (1) Provides an integrated interdisciplinary rehabilitation program 
designed to upgrade the physical functioning of handicapped disabled 
individuals by bringing specialized rehabilitation staff together to 
perform as a team; and
    (2) Provides at least physical therapy or speech-language pathology 
services.
    Supervision. Authoritative procedural guidance that is for the 
accomplishment of a function or activity and that--
    (1) Includes initial direction and periodic observation of the 
actual performance of the function or activity; and
    (2) Is furnished by a qualified person--
    (i) Whose sphere of competence encompasses the particular function 
or activity; and
    (ii) Who (unless otherwise provided in this subpart) is on the 
premises if the person performing the function or activity does not meet 
the assistant-level practitioner qualifications specified in Sec. 
485.705.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988; 54 FR 38679, Sept. 20, 1989. 
Redesignated and amended at 60 FR 2326, 2327, Jan. 9, 1995; 60 FR 50447, 
Sept. 29, 1995; 73 FR 69941, Nov. 19, 2008]



Sec. 485.705  Personnel qualifications.

    (a) General qualification requirements. Except as specified in 
paragraphs (b) and (c) of this section, all personnel who are involved 
in the furnishing of outpatient physical therapy, occupational therapy, 
and speech-language pathology services directly by or under arrangements 
with an organization must be legally authorized (licensed or, if 
applicable, certified or registered) to practice by the State in which 
they perform the functions or actions, and must act only within the 
scope of their State license or State certification or registration.
    (b) Exception for Federally defined qualifications. The following 
Federally defined qualifications must be met:
    (1) For a physician, the qualifications and conditions as defined in 
section 1861(r) of the Act and the requirements in part 484 of this 
chapter.
    (2) For a speech-language pathologist, the qualifications specified 
in section 1861(11)(1) of the Act and the requirements in part 484 of 
this chapter.
    (c) Exceptions when no State Licensing laws or State certification 
or registration requirements exist. If no State licensing laws or State 
certification or registration requirements exist for the profession, the 
following requirements must be met--
    (1) An administrator is a person who has a bachelor's degree and:
    (i) Has experience or specialized training in the administration of 
health institutions or agencies; or
    (ii) Is qualified and has experience in one of the professional 
health disciplines.
    (2) An occupational therapist must meet the requirements in part 484 
of this chapter.
    (3) An occupational therapy assistant must meet the requirements in 
part 484 of this chapter.
    (4) A physical therapist must meet the requirements in part 484 of 
this chapter.
    (5) A physical therapist assistant must meet the requirements in 
part 484 of this chapter.
    (6) A social worker must meet the requirements in part 484 of this 
chapter.
    (7) A vocational specialist is a person who has a baccalaureate 
degree and--
    (i) Two years experience in vocational counseling in a 
rehabilitation setting such as a sheltered workshop, State employment 
service agency, etc.; or
    (ii) At least 18 semester hours in vocational rehabilitation, 
educational or vocational guidance, psychology, social work, special 
education or personnel administration, and 1 year of experience in 
vocational counseling in a rehabilitation setting; or
    (iii) A master's degree in vocational counseling.

[[Page 225]]

    (8) A nurse practitioner is a person who must:
    (i) Be a registered professional nurse who is authorized by the 
State in which the services are furnished to practice as a nurse 
practitioner in accordance with State law; and
    (ii) Be certified as a nurse practitioner by a recognized national 
certifying body that has established standards for nurse practitioners; 
or
    (iii) Be a registered professional nurse who is authorized by the 
State in which the services are furnished to practice as a nurse 
practitioner in accordance with State law and have been granted a 
Medicare billing number as a nurse practitioner by December 31, 2000; or
    (iv) Be a nurse practitioner who on or after January 1, 2001, 
applies for a Medicare billing number for the first time and meets the 
standards for nurse practitioners in paragraphs (c)(8)(i) and (c)(8)(ii) 
of this section; or
    (v) Be a nurse practitioner who on or after January 1, 2003, applies 
for a Medicare billing number for the first time and possesses a 
master's degree in nursing and meets the standards for nurse 
practitioners in paragraphs (b)(1)(i) and (b)(1)(ii) of this section.
    (9) A clinical nurse specialist is a person who must:
    (i) Be a registered nurse who is currently licensed to practice in 
the State where he or she practices and be authorized to perform the 
services of a clinical nurse specialist in accordance with State law;
    (ii) Have a master's degree in a defined clinical area of nursing 
from an accredited educational institution; and,
    (iii) Be certified as a clinical nurse specialist by the American 
Nurses Credentialing Center.
    (10) A physician assistant is a person who:
    (i) Has graduated from a physician assistant educational program 
that is accredited by the Commission on Accreditation of Allied Health 
Education Programs; or
    (ii) Has passed the national certification examination that is 
administered by the National Commission on Certification of Physician 
Assistants; and
    (iii) Is licensed by the State to practice as a physician assistant.

[63 FR 58912, Nov. 2, 1998; 64 FR 25457, May 12, 1999; 64 FR 59442, Nov. 
2, 1999]



Sec. 485.707  Condition of participation: Compliance with Federal,
State, and local laws.

    The organization and its staff are in compliance with all applicable 
Federal, State, and local laws and regulations.
    (a) Standard: Licensure of organization. In any State in which State 
or applicable local law provides for the licensing of organizations, a 
clinic, rehabilitation agency, or public health agency is licensed in 
accordance with applicable laws.
    (b) Standard: Licensure or registration of personnel. Staff of the 
organization are licensed or registered in accordance with applicable 
laws.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, 2327, Jan. 9, 1995]



Sec. 485.709  Condition of participation: Administrative management.

    The clinic or rehabilitation agency has an effective governing body 
that is legally responsible for the conduct of the clinic or 
rehabilitation agency. The governing body designates an administrator, 
and establishes administrative policies.
    (a) Standard: Governing body. There is a governing body (or 
designated person(s) so functioning) which assumes full legal 
responsibility for the overall conduct of the clinic or rehabilitation 
agency and for compliance with applicable laws and regulations. The name 
of the owner(s) of the clinic or rehabilitation agency is fully 
disclosed to the State agency. In the case of corporations, the names of 
the corporate officers are made known.
    (b) Standard: Administrator. The governing body--
    (1) Appoints a qualified full-time administrator;
    (2) Delegates to the administrator the internal operation of the 
clinic or rehabilitation agency in accordance with written policies;
    (3) Defines clearly the administrator's responsibilities for 
procurement and direction of personnel; and

[[Page 226]]

    (4) Designates a competent individual to act during temporary 
absence of the administrator.
    (c) Standard: Personnel policies. Personnel practices are supported 
by appropriate written personnel policies that are kept current. 
Personnel records include the qualifications of all professional and 
assistant level personnel, as well as evidence of State licensure if 
applicable.
    (d) Standard: Patient care policies. Patient care practices and 
procedures are supported by written policies established by a group of 
professional personnel including one or more physicians associated with 
the clinic or rehabilitation agency, one or more qualified physical 
therapists (if physical therapy services are provided), and one or more 
qualified speech pathologists (if speech pathology services are 
provided). The policies govern the outpatient physical therapy and/or 
speech pathology services and related services that are provided. These 
policies are evaluated at least annually by the group of professional 
personnel, and revised as necessary based upon this evaluation.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988. Redesignated and amended at 
60 FR 2326, 2327, Jan. 9, 1995; 60 FR 50447, Sept. 29, 1995]



Sec. 485.711  Condition of participation: Plan of care and physician
involvement.

    For each patient in need of outpatient physical therapy or speech 
pathology services, there is a written plan of care established and 
periodically reviewed by a physician, or by a physical therapist or 
speech pathologist respectively.
    (a) Standard: Medical history and prior treatment. The following are 
obtained by the organization before or at the time of initiation of 
treatment:
    (1) The patient's significant past history.
    (2) Current medical findings, if any.
    (3) Diagnosis(es), if established.
    (4) Physician's orders, if any.
    (5) Rehabilitation goals, if determined.
    (6) Contraindications, if any.
    (7) The extent to which the patient is aware of the diagnosis(es) 
and prognosis.
    (8) If appropriate, the summary of treatment furnished and results 
achieved during previous periods of rehabilitation services or 
institutionalization.
    (b) Standard: Plan of care. (1) For each patient there is a written 
plan of care established by the physician or by the physical therapist 
or speech-language pathologist who furnishes the services.
    (2) The plan of care for physical therapy or speech pathology 
services indicates anticipated goals and specifies for those services 
the--
    (i) Type;
    (ii) Amount;
    (iii) Frequency; and
    (iv) Duration.
    (3) The plan of care and results of treatment are reviewed by the 
physician or by the individual who established the plan at least as 
often as the patient's condition requires, and the indicated action is 
taken.
    (4) Changes in the plan of care are noted in the clinical record. If 
the patient has an attending physician, the therapist or speech-language 
pathologist who furnishes the services promptly notifies him or her of 
any change in the patient's condition or in the plan of care.
    (c) Standard: Emergency care. The rehabilitation agency must 
establish procedures to be followed by personnel in an emergency, which 
cover immediate care of the patient, persons to be notified, and reports 
to be prepared.

[54 FR 38679, Sept. 20, 1989. Redesignated and amended at 60 FR 2326, 
2327, Jan. 9, 1995; 63 FR 58913, Nov. 2, 1998; 73 FR 69941, Nov. 19, 
2008]



Sec. 485.713  Condition of participation: Physical therapy services.

    If the organization offers physical therapy services, it provides an 
adequate program of physical therapy and has an adequate number of 
qualified personnel and the equipment necessary to carry out its program 
and to fulfill its objectives.
    (a) Standard: Adequate program. (1) The organization is considered 
to have an adequate outpatient physical therapy program if it can:

[[Page 227]]

    (i) Provide services using therapeutic exercise and the modalities 
of heat, cold, water, and electricity;
    (ii) Conduct patient evaluations; and
    (iii) Administer tests and measurements of strength, balance, 
endurance, range of motion, and activities of daily living.
    (2) A qualified physical therapist is present or readily available 
to offer supervision when a physical therapist assistant furnishes 
services.
    (i) If a qualified physical therapist is not on the premises during 
all hours of operation, patients are scheduled so as to ensure that the 
therapist is present when special skills are needed, for example, for 
evaluation and reevaluation.
    (ii) When a physical therapist assistant furnishes services off the 
organization's premises, those services are supervised by a qualified 
physical therapist who makes an onsite supervisory visit at least once 
every 30 days.
    (b) Standard: Facilities and equipment. The organization has the 
equipment and facilities required to provide the range of services 
necessary in the treatment of the types of disabilities it accepts for 
service.
    (c) Standard: Personnel qualified to provide physical therapy 
services. Physical therapy services are provided by, or under the 
supervision of, a qualified physical therapist. The number of qualified 
physical therapists and qualified physical therapist assistants is 
adequate for the volume and diversity of physical therapy services 
offered. A qualified physical therapist is on the premises or readily 
available during the operating hours of the organization.
    (d) Standard: Supportive personnel. If personnel are available to 
assist qualified physical therapists by performing services incident to 
physical therapy that do not require professional knowledge and skill, 
these personnel are instructed in appropriate patient care services by 
qualified physical therapists who retain responsibility for the 
treatment prescribed by the attending physician.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, 2327, Jan. 9, 1995; 60 
FR 50447, Sept. 29, 1995]



Sec. 485.715  Condition of participation: Speech pathology services.

    If speech pathology services are offered, the organization provides 
an adequate program of speech pathology and has an adequate number of 
qualified personnel and the equipment necessary to carry out its program 
and to fulfill its objectives.
    (a) Standard: Adequate program. The organization is considered to 
have an adequate outpatient speech pathology program if it can provide 
the diagnostic and treatment services to effectively treat speech 
disorders.
    (b) Standard: Facilities and equipment. The organization has the 
equipment and facilities required to provide the range of services 
necessary in the treatment of the types of speech disorders it accepts 
for service.
    (c) Standard: Personnel qualified to provide speech pathology 
services. Speech pathology services are given or supervised by a 
qualified speech pathologist and the number of qualified speech 
pathologists is adequate for the volume and diversity of speech 
pathology services offered. At least one qualified speech pathologist is 
present at all times when speech pathology services are furnished.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995]



Sec. 485.717  Condition of participation: Rehabilitation program.

    This condition and standards apply only to a rehabilitation agency's 
own patients, not to patients of hospitals, skilled nursing facilities 
(SNFs), or Medicaid nursing facilities (NFs) to which the agency 
furnishes services. The hospital, SNF, or NF is responsible for ensuring 
that qualified staff furnish services for which they arrange or contract 
for their patients. The rehabilitation agency provides physical therapy 
and speech-language pathology services to all of its patients who need 
them.
    (a) Standard: Qualification of staff. The agency's therapy services 
are furnished by qualified individuals as direct services and/or 
services provided under contract.
    (b) Standard: Arrangements for services. If services are provided 
under contract,

[[Page 228]]

the contract must specify the term of the contract, the manner of 
termination or renewal and provide that the agency retains 
responsibility for the control and supervision of the services.

[73 FR 69942, Nov. 19, 2008]



Sec. 485.719  Condition of participation: Arrangements for physical 
therapy and speech pathology services to be performed by other than 
salaried organization personnel.
          

    (a) Conditions. If an organization provides outpatient physical 
therapy or speech pathology services under an arrangement with others, 
the services are to be furnished in accordance with the terms of a 
written contract, which provides that the organization retains of 
professional and administrative responsibility for, and control and 
supervision of, the services.
    (b) Standard: Contract provisions. The contract--
    (1) Specifies the term of the contract and the manner of termination 
or renewal;
    (2) Requires that personnel who furnish the services meet the 
requirements that are set forth in this subpart for salaried personnel; 
and
    (3) Provides that the contracting outside resource may not bill the 
patient or Medicare for the services. This limitation is based on 
section 1861(w)(1) of the Act, which provides that--
    (i) Only the provider may bill the beneficiary for covered services 
furnished under arrangements; and
    (ii) Receipt of Medicare payment by the provider, on behalf of an 
entitled individual, discharges the liability of the individual or any 
other person to pay for those services.

[56 FR 46562, Sept. 13, 1991. Redesignated and amended at 60 FR 2326, 
2328, Jan. 9, 1995; 60 FR 50447, Sept. 29, 1995]



Sec. 485.721  Condition of participation: Clinical records.

    The organization maintains clinical records on all patients in 
accordance with accepted professional standards, and practices. The 
clinical records are completely and accurately documented, readily 
accessible, and systematically organized to facilitate retrieving and 
compiling information.
    (a) Standard: Protection of clinical record information. The 
organization recognizes the confidentiality of clinical record 
information and provides safeguards against loss, destruction, or 
unauthorized use. Written procedures govern the use and removal of 
records and the conditions for release of information. The patient's 
written consent is required for release of information not authorized by 
law.
    (b) Standard: Content. The clinical record contains sufficient 
information to identify the patient clearly, to justify the 
diagnosis(es) and treatment, and to document the results accurately. All 
clinical records contain the following general categories of data:
    (1) Documented evidence of the assessment of the needs of the 
patient, of an appropriate plan of care, and of the care and services 
furnished.
    (2) Identification data and consent forms.
    (3) Medical history.
    (4) Report of physical examinations, if any.
    (5) Observations and progress notes.
    (6) Reports of treatments and clinical findings.
    (7) Discharge summary including final diagnosis(es) and prognosis.
    (c) Standard: Completion of records and centralization of reports. 
Current clinical records and those of discharged patients are completed 
promptly. All clinical information pertaining to a patient is 
centralized in the patient's clinical record. Each physician signs the 
entries that he or she makes in the clinical record.
    (d) Standard: Retention and preservation. Clinical records are 
retained for at least:
    (1) The period determined by the respective State statute, or the 
statute of limitations in the State; or
    (2) In the absence of a State statute--
    (i) Five years after the date of discharge; or
    (ii) In the case of a minor, 3 years after the patient becomes of 
age under State law or 5 years after the date of discharge, whichever is 
longer.
    (e) Standard: Indexes. Clinical records are indexed at least 
according to name of patient to facilitate acquisition of

[[Page 229]]

statistical medical information and retrieval of records for research or 
administrative action.
    (f) Standard: Location and facilities. The organization maintains 
adequate facilities and equipment, conveniently located, to provide 
efficient processing of clinical records (reviewing, indexing, filing, 
and prompt retrieval).

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995]



Sec. 485.723  Condition of participation: Physical environment.

    The building housing the organization is constructed, equipped, and 
maintained to protect the health and safety of patients, personnel, and 
the public and provides a functional, sanitary, and comfortable 
environment.
    (a) Standard: Safety of patients. The organization satisfies the 
following requirements:
    (1) It complies with all applicable State and local building, fire, 
and safety codes.
    (2) Permanently attached automatic fire-extinguishing systems of 
adequate capacity are installed in all areas of the premises considered 
to have special fire hazards. Fire extinguishers are conveniently 
located on each floor of the premises. Fire regulations are prominently 
posted.
    (3) Doorways, passageways and stairwells negotiated by patients are:
    (i) Of adequate width to allow for easy movement of all patients 
(including those on stretchers or in wheelchairs), (ii) free from 
obstruction at all times, and (iii) in the case of stairwells, equipped 
with firmly attached handrails on at least one side.
    (4) Lights are placed at exits and in corridors used by patients and 
are supported by an emergency power source.
    (5) A fire alarm system with local alarm capability and, where 
applicable, an emergency power source, is functional.
    (6) At least two persons are on duty on the premises of the 
organization whenever a patient is being treated.
    (7) No occupancies or activities undesirable or injurious to the 
health and safety of patients are located in the building.
    (b) Standard: Maintenance of equipment, building, and grounds. The 
organization establishes a written preventive-maintenance program to 
ensure that--
    (1) The equipment is operative, and is properly calibrated; and
    (2) The interior and exterior of the building are clean and orderly 
and maintained free of any defects that are a potential hazard to 
patients, personnel, and the public.
    (c) Standard: Other environmental considerations. The organization 
provides a functional, sanitary, and comfortable environment for 
patients, personnel, and the public.
    (1) Provision is made for adequate and comfortable lighting levels 
in all areas; limitation of sounds at comfort levels; a comfortable room 
temperature; and adequate ventilation through windows, mechanical means, 
or a combination of both.
    (2) Toilet rooms, toilet stalls, and lavatories are accessible and 
constructed so as to allow use by nonambulatory and semiambulatory 
individuals.
    (3) Whatever the size of the building, there is an adequate amount 
of space for the services provided and disabilities treated, including 
reception area, staff space, examining room, treatment areas, and 
storage.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995]



Sec. 485.725  Condition of participation: Infection control.

    The organization that provides outpatient physical therapy services 
establishes an infection-control committee of representative 
professional staff with responsibility for overall infection control. 
All necessary housekeeping and maintenance services are provided to 
maintain a sanitary and comfortable environment and to help prevent the 
development and transmission of infection.
    (a) Standard: Infection-control committee. The infection-control 
committee establishes policies and procedures for investigating, 
controlling, and preventing infections in the organization and monitors 
staff performance to ensure that the policies and procedures are 
executed.

[[Page 230]]

    (b) All personnel follow written procedures for effective aseptic 
techniques. The procedures are reviewed annually and revised if 
necessary to improve them.
    (c) Standard: Housekeeping. (1) The organization employs sufficient 
housekeeping personnel and provides all necessary equipment to maintain 
a safe, clean, and orderly interior. A full-time employee is designated 
as the one responsible for the housekeeping services and for supervision 
and training of housekeeping personnel.
    (2) An organization that has a contract with an outside resource for 
housekeeping services may be found to be in compliance with this 
standard provided the organization or outside resource or both meet the 
requirements of the standard.
    (d) Standard: Linen. The organization has available at all times a 
quantity of linen essential for proper care and comfort of patients. 
Linens are handled, stored, processed, and transported in such a manner 
as to prevent the spread of infection.
    (e) Standard: Pest control. The organization's premises are 
maintained free from insects and rodents through operation of a pest-
control program.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, 2328, Jan. 9, 1995; 60 
FR 50447, Sept. 29, 1995]



Sec. 485.727  Condition of participation: Emergency preparedness.

    The Clinics, Rehabilitation Agencies, and Public Health Agencies as 
Providers of Outpatient Physical Therapy and Speech-Language Pathology 
Services (``Organizations'') must comply with all applicable Federal, 
State, and local emergency preparedness requirements. The Organizations 
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 Organizations must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
every 2 years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the Organizations have the ability to provide in an 
emergency; and continuity of operations, including delegations of 
authority and succession plans.
    (4) Address the location and use of alarm systems and signals; and 
methods of containing fire.
    (5) 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.
    (6) Be developed and maintained with assistance from fire, safety, 
and other appropriate experts.
    (b) Policies and procedures. The Organizations 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) Safe evacuation from the Organizations, which includes staff 
responsibilities, and needs of the patients.
    (2) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (3) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (4) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State and Federally designated health care professionals to address 
surge needs during an emergency.
    (c) Communication plan. The Organizations must develop and maintain 
an

[[Page 231]]

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) Patients' physicians.
    (iv) Other Organizations.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, state, tribal, regional and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) Organizations' staff.
    (ii) Federal, state, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
patients under the Organizations' care, as necessary, with other health 
care providers to maintain the continuity of care.
    (5) A means of providing information about the Organizations' needs, 
and their ability to provide assistance, to the authority having 
jurisdiction or the Incident Command Center, or designee.
    (d) Training and testing. The Organizations 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 Organizations must do all of the 
following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the Organizations must conduct training on the 
updated policies and procedures.
    (2) Testing. The Organizations must conduct exercises to test the 
emergency plan at least annually. The Organizations must do the 
following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, an 
individual, facility-based functional exercise every 2 years; or.
    (B) If the Organizations experience an actual natural or man-made 
emergency that requires activation of the emergency plan, the 
organization 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 Organization's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise their emergency plan, as needed.
    (e) Integrated healthcare systems. If the Organizations are part of 
a healthcare system consisting of multiple separately certified 
healthcare facilities

[[Page 232]]

that elects to have a unified and integrated emergency preparedness 
program, the Organizations may choose to participate in the healthcare 
system's coordinated emergency preparedness program. If elected, the 
unified and integrated emergency preparedness program must do all of 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.
    (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 
all of 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 64037, Sept. 16, 2016, as amended by 84 FR 51829, Sept. 30, 2019]



Sec. 485.729  Condition of participation: Program evaluation.

    The organization has procedures that provide for a systematic 
evaluation of its total program to ensure appropriate utilization of 
services and to determine whether the organization's policies are 
followed in providing services to patients through employees or under 
arrangements with others.
    (a) Standard: Clinical-record review. A sample of active and closed 
clinical records is reviewed quarterly by the appropriate health 
professionals to ensure that established policies are followed in 
providing services.
    (b) Standard: Annual statistical evaluation. An evaluation is 
conducted annually of statistical data such as number of different 
patients treated, number of patient visits, condition on admission and 
discharge, number of new patients, number of patients by diagnosis(es), 
sources of referral, number and cost of units of service by treatment 
given, and total staff days or work hours by discipline.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, 2329, Jan. 9, 1995]

Subpart I [Reserved]



 Subpart J_Conditions of Participation: Community Mental Health Centers 
                                 (CMHCs)

    Source: 78 FR 64630, Oct. 29, 2013, unless otherwise noted.



Sec. 485.900  Basis and scope.

    (a) Basis. This subpart is based on the following sections of the 
Social Security Act:
    (1) Section 1832(a)(2)(J) of the Act specifies that payments may be 
made under Medicare Part B for partial hospitalization services 
furnished by a community mental health center (CMHC) as described in 
section 1861(ff)(3)(B) of the Act.
    (2) Section 1861(ff) of the Act describes the items and services 
that are covered under Medicare Part B as ``partial hospitalization 
services'' and the conditions under which the items and services must be 
provided. In addition, section 1861(ff) of the Act specifies that the 
entities authorized to provide partial hospitalization services under 
Medicare Part B include CMHCs and defines that term.
    (3) Section 1866(e)(2) of the Act specifies that a provider of 
services for purposes of provider agreement requirements includes a CMHC 
as defined in section 1861(ff)(3)(B) of the Act, but

[[Page 233]]

only with respect to providing partial hospitalization services.
    (b) Scope. The provisions of this subpart serve as the basis of 
survey activities for the purpose of determining whether a CMHC meets 
the specified requirements that are considered necessary to ensure the 
health and safety of clients; and for the purpose of determining whether 
a CMHC qualifies for a provider agreement under Medicare.



Sec. 485.902  Definitions.

    As used in this subpart, unless the context indicates otherwise--
    Active treatment plan means an individualized client plan that 
focuses on the provision of care and treatment services that address the 
client's physical, psychological, psychosocial, emotional, and 
therapeutic needs and goals as identified in the comprehensive 
assessment.
    Community mental health center (CMHC) means an entity as defined in 
Sec. 410.2 of this chapter.
    Comprehensive assessment means a thorough evaluation of the client's 
physical, psychological, psychosocial, emotional, and therapeutic needs 
related to the diagnosis under which care is being furnished by the 
CMHC.
    Employee of a CMHC means an individual--
    (1) Who works for the CMHC and for whom the CMHC is required to 
issue a W-2 form on his or her behalf; or
    (2) For whom an agency or organization issues a W-2 form, and who is 
assigned to such CMHC if the CMHC is a subdivision of an agency or 
organization.
    Initial evaluation means an immediate care and support assessment of 
the client's physical, psychosocial (including a screen for harm to self 
or others), and therapeutic needs related to the psychiatric illness and 
related conditions for which care is being furnished by the CMHC.
    Representative means an individual who has the authority under State 
law to authorize or terminate medical care on behalf of a client who is 
mentally or physically incapacitated. This includes a legal guardian.
    Restraint means--
    (1) Any manual method, physical or mechanical device, material, or 
equipment that immobilizes or reduces the ability of a client to move 
his or her arms, legs, body, or head freely, not including devices, such 
as orthopedically prescribed devices, surgical dressings or bandages, 
protective helmets, or other methods that involve the physical holding 
of a client for the purpose of conducting routine physical examinations 
or tests, or to protect the client from falling out of bed, or to permit 
the client to participate in activities without the risk of physical 
harm (this does not include a client being physically escorted); or
    (2) A drug or medication when it is used as a restriction to manage 
the client's behavior or restrict the client's freedom of movement, and 
which is not a standard treatment or dosage for the client's condition.
    Seclusion means the involuntary confinement of a client alone in a 
room or an area from which the client is physically prevented from 
leaving.
    Volunteer means an individual who is an unpaid worker of the CMHC; 
or if the CMHC is a subdivision of an agency or organization, is an 
unpaid worker of the agency or organization and is assigned to the CMHC. 
All volunteers must meet the standard training requirements under Sec. 
485.918(d).



Sec. 485.904  Condition of participation: Personnel qualifications.

    (a) Standard: General qualification requirements. All professionals 
who furnish services directly, under an individual contract, or under 
arrangements with a CMHC, must be legally authorized (licensed, 
certified or registered) in accordance with applicable Federal, State 
and local laws, and must act only within the scope of their State 
licenses, certifications, or registrations. All personnel qualifications 
must be kept current at all times.
    (b) Standard: Personnel qualifications for certain disciplines. The 
following qualifications must be met:
    (1) Administrator of a CMHC. A CMHC employee who meets the education 
and experience requirements established by the CMHC's governing body for 
that position and who is responsible for the day-to-day operation of the 
CMHC.

[[Page 234]]

    (2) Clinical psychologist. An individual who meets the 
qualifications at Sec. 410.71(d) of this chapter.
    (3) Clinical Social worker. An individual who meets the 
qualifications at Sec. 410.73 of this chapter.
    (4) Social worker. An individual who--
    (i) Has a baccalaureate degree in social work from an institution 
accredited by the Council on Social Work Education, or a baccalaureate 
degree in psychology or sociology, and is supervised by a clinical 
social worker, as described in paragraph (b)(3) of this section; and
    (ii) Has 1 year of social work experience in a psychiatric 
healthcare setting.
    (5) Mental health counselor. A professional counselor who is 
certified and/or licensed by the State in which he or she practices, and 
has the skills and knowledge to provide a range of behavioral health 
services to clients. The mental health counselor conducts assessments 
and provides services in areas such as psychotherapy, substance abuse, 
crisis management, psychoeducation, and prevention programs.
    (6) Occupational therapist. A person who meets the requirements for 
the definition of ``occupational therapist'' at Sec. 484.4 of this 
chapter.
    (7) Physician. An individual who meets the qualifications and 
conditions as defined in section 1861(r) of the Act, and provides the 
services at Sec. 410.20 of this chapter, and has experience providing 
mental health services to clients.
    (8) Physician assistant. An individual who meets the qualifications 
and conditions as defined in section 1861(s)(2)(K)(i) of the Act and 
provides the services, in accordance with State law, at Sec. 410.74 of 
this chapter.
    (9) Advanced practice nurse. An individual who meets the following 
qualifications:
    (i) Is a nurse practitioner who meets the qualifications at Sec. 
410.75 of this chapter; or
    (ii) Is a clinical nurse specialist who meets the qualifications at 
Sec. 410.76 of this chapter.
    (10) Psychiatric registered nurse. A registered nurse, who is a 
graduate of an approved school of professional nursing, is licensed as a 
registered nurse by the State in which he or she is practicing, and has 
at least 1 year of education and/or training in psychiatric nursing.
    (11) Psychiatrist. An individual who specializes in assessing and 
treating persons having psychiatric disorders; is board certified, or is 
eligible to be board certified by the American Board of Psychiatry and 
Neurology, or has documented equivalent education, training or 
experience, and is fully licensed to practice medicine in the State in 
which he or she practices.



Sec. 485.910  Condition of participation: Client rights.

    The client has the right to be informed of his or her rights. The 
CMHC must protect and promote the exercise of these client rights.
    (a) Standard: Notice of rights and responsibilities. (1) During the 
initial evaluation, the CMHC must provide the client, the client's 
representative (if appropriate) or surrogate with verbal and written 
notice of the client's rights and responsibilities. The verbal notice 
must be in a language and manner that the client or client's 
representative or surrogate understands. Written notice must be 
understandable to persons who have limited English proficiency.
    (2) During the initial evaluation, the CMHC must inform and 
distribute written information to the client concerning its policies on 
filing a grievance.
    (3) The CMHC must obtain the client's and/or the client 
representative's signature confirming that he or she has received a copy 
of the notice of rights and responsibilities.
    (b) Standard: Exercise of rights and respect for property and 
person. (1) The client has the right to--
    (i) Exercise his or her rights as a client of the CMHC.
    (ii) Have his or her property and person treated with respect.
    (iii) Voice grievances and understand the CMHC grievance process; 
including but not limited to grievances regarding mistreatment and 
treatment or care that is (or fails to be) furnished.
    (iv) Not be subjected to discrimination or reprisal for exercising 
his or her rights.

[[Page 235]]

    (2) If a client has been adjudged incompetent under State law by a 
court of proper jurisdiction, the rights of the client are exercised by 
the person appointed in accordance with State law to act on the client's 
behalf.
    (3) If a State court has not adjudged a client incompetent, any 
legal representative designated by the client in accordance with State 
law may exercise the client's rights to the extent allowed under State 
law.
    (c) Standard: Rights of the client. The client has a right to--
    (1) Be involved in developing his or her active treatment plan.
    (2) Refuse care or treatment.
    (3) Have a confidential clinical record. Access to or release of 
client information and the clinical record client information is 
permitted only in accordance with 45 CFR parts 160 and 164.
    (4) Be free from mistreatment, neglect, or verbal, mental, sexual, 
and physical abuse, including injuries of unknown source, and 
misappropriation of client property.
    (5) Receive information about specific limitations on services that 
he or she will be furnished.
    (6) Not be compelled to perform services for the CMHC, and to be 
compensated by the CMHC for any work performed for the CMHC at 
prevailing wages and commensurate with the client's abilities.
    (d) Standard: Addressing violations of client rights. The CMHC must 
adhere to the following requirements:
    (1) Ensure that all alleged violations involving mistreatment, 
neglect, or verbal, mental, sexual, and physical abuse, including 
injuries of unknown source, and misappropriation of client property by 
anyone, including those furnishing services on behalf of the CMHC, are 
reported immediately to the CMHC's administrator by CMHC employees, 
volunteers and contracted staff.
    (2) Immediately investigate all alleged violations involving anyone 
furnishing services on behalf of the CMHC and immediately take action to 
prevent further potential violations while the alleged violation is 
being verified. Investigations and documentation of all alleged 
violations must be conducted in accordance with procedures established 
by the CMHC.
    (3) Take appropriate corrective action in accordance with State law 
if the alleged violation is investigated by the CMHC's administration or 
verified by an outside entity having jurisdiction, such as the State 
survey and certification agency or the local law enforcement agency; and
    (4) Ensure that, within 5 working days of becoming aware of the 
violation, all violations are reported to the State survey and 
certification agency, and verified violations are reported to State and 
local entities having jurisdiction.
    (e) Standard: Restraint and seclusion. (1) All clients have the 
right to be free from physical or mental abuse, and corporal punishment. 
All clients have the right to be free from restraint or seclusion, of 
any form, imposed as a means of coercion, discipline, convenience, or 
retaliation by staff. Restraint or seclusion, defined in Sec. 485.902, 
may only be imposed to ensure the immediate physical safety of the 
client, staff, or other individuals.
    (2) The use of restraint or seclusion must be in accordance with the 
written order of a physician or other licensed independent practitioner 
who is authorized to order restraint or seclusion in accordance with 
State law and must not exceed one 1-hour duration per order.
    (3) The CMHC must obtain a corresponding order for the client's 
immediate transfer to a hospital when restraint or seclusion is ordered.
    (4) Orders for the use of restraint or seclusion must never be 
written as a standing order or on an as-needed basis.
    (5) When a client becomes an immediate threat to the physical safety 
of himself or herself, staff or other individuals, the CMHC must adhere 
to the following requirements:
    (i) Restraint or seclusion may only be used when less restrictive 
interventions have been determined to be ineffective to protect the 
client or other individuals from harm.

[[Page 236]]

    (ii) The type or technique of restraint or seclusion used must be 
the least restrictive intervention that will be effective to protect the 
client or other individuals from harm.
    (iii) The use of restraint or seclusion must be implemented in 
accordance with safe and appropriate restraint and seclusion techniques 
as determined by State law.
    (iv) The condition of the client who is restrained or secluded must 
be continuously monitored by a physician or by trained staff who have 
completed the training criteria specified in paragraph (f) of this 
section.
    (v) When restraint or seclusion is used, there must be documentation 
in the client's clinical record of the following:
    (A) A description of the client's behavior and the intervention 
used.
    (B) Alternatives or other less restrictive interventions attempted 
(as applicable).
    (C) The client's condition or symptom(s) that warranted the use of 
the restraint or seclusion.
    (D) The client's response to the intervention(s) used, including the 
rationale for continued use of the intervention.
    (E) The name of the hospital to which the client was transferred.
    (f) Standard: Restraint or seclusion: Staff training requirements. 
The client has the right to safe implementation of restraint or 
seclusion by trained staff. Application of restraint or seclusion in a 
CMHC must only be imposed when a client becomes an immediate physical 
threat to himself or herself, staff or other individuals and only in 
facilities where restraint and seclusion are permitted.
    (1) Training intervals. In facilities where restraint and seclusion 
are permitted, all appropriate client care staff working in the CMHC 
must be trained and able to demonstrate competency in the application of 
restraints, implementation of seclusion, monitoring, assessment, and 
providing care for a client in restraint or seclusion and use of 
alternative methods to restraint and seclusion. In facilities where 
restraint and seclusion are not permitted, appropriate client care staff 
working in CMHC must be trained in the use of alternative methods to 
restraint and seclusion. Training will occur as follows:
    (i) Before performing any of the actions specified in this paragraph 
(f).
    (ii) As part of orientation.
    (iii) Subsequently on a periodic basis, consistent with the CMHC's 
policy.
    (2) Training content. The CMHC must require all appropriate staff 
caring for clients to have appropriate education, training, and 
demonstrated knowledge based on the specific needs of the client 
population in at least the following:
    (i) Techniques to identify staff and client behaviors, events, and 
environmental factors that may trigger circumstances that could require 
the use of restraint or seclusion.
    (ii) The use of nonphysical intervention skills.
    (iii) In facilities where restraint and seclusion are permitted, 
choosing the least restrictive intervention based on an individualized 
assessment of the client's medical and behavioral status or condition.
    (iv) The safe application and use of all types of restraint or 
seclusion that are permitted in the CMHC, including training in how to 
recognize and respond to signs of physical and psychological distress.
    (v) In facilities where restraint and seclusion are permitted, 
clinical identification of specific behavioral changes that indicate 
that restraint or seclusion is no longer necessary.
    (vi) In facilities where restraint and seclusion are permitted, 
monitoring the physical and psychological well-being of the client who 
is restrained or secluded, including, but not limited to, respiratory 
and circulatory status, skin integrity, vital signs, and any special 
requirements specified by the CMHC's policy.
    (3) Trainer requirements. Individuals providing staff training must 
be qualified as evidenced by education, training, and experience in 
techniques used to address clients' behaviors.
    (4) Training documentation. The CMHC must document in the staff 
personnel records that the training and demonstration of competency were 
successfully completed.
    (g) Standard: Death reporting requirements. The CMHC must report 
deaths

[[Page 237]]

associated with the use of seclusion or restraint.
    (1) The CMHC must report to CMS each death that occurs while a 
client is in restraint or seclusion awaiting transfer to a hospital.
    (2) Each death referenced in paragraph (g)(1) of this section must 
be reported to the CMS Regional Office by telephone no later than the 
close of business the next business day following knowledge of the 
client's death.
    (3) Staff must document in the client's clinical record the date and 
time the death was reported to CMS.



Sec. 485.914  Condition of participation: Admission, initial evaluation,
comprehensive assessment, and discharge or transfer of the client.

    The CMHC must ensure that all clients admitted into its program are 
appropriate for the services the CMHC furnishes in its facility.
    (a) Standard: Admission. (1) The CMHC must determine that each 
client is appropriate for the services it provides as specified in Sec. 
410.2 of this chapter.
    (2) For clients assessed and admitted to receive partial 
hospitalization services, the CMHC must also meet separate requirements 
as specified in Sec. 485.918(f).
    (b) Standard: Initial evaluation. (1) A licensed mental health 
professional employed by the CMHC and acting within his or her state 
scope of practice requirements must complete the initial evaluation 
within 24 hours of the client's admission to the CMHC.
    (2) The initial evaluation, at a minimum, must include the 
following:
    (i) The admitting diagnosis as well as other diagnoses.
    (ii) The source of referral.
    (iii) The reason for admission as stated by the client or other 
individuals who are significantly involved.
    (iv) Identification of the client's immediate clinical care needs 
related to the psychiatric diagnosis.
    (v) A list of current prescriptions and over-the-counter 
medications, as well as other substances that the client may be taking.
    (vi) For partial hospitalization services only, include an 
explanation as to why the client would be at risk for hospitalization if 
the partial hospitalization services were not provided.
    (3) Based on the findings of the initial evaluation, the CMHC must 
determine the appropriate members of each client's interdisciplinary 
treatment team.
    (c) Standard: Comprehensive assessment. (1) The comprehensive 
assessment must be completed by licensed mental health professionals who 
are members of the interdisciplinary treatment team, performing within 
their State's scope of practice.
    (2) The comprehensive assessment must be completed in a timely 
manner, consistent with the client's immediate needs, but no later than 
4 working days after admission to the CMHC.
    (3) The comprehensive assessment must identify the physical, 
psychological, psychosocial, emotional, therapeutic, and other needs 
related to the client's psychiatric illness. The CMHC's 
interdisciplinary treatment team must ensure that the active treatment 
plan is consistent with the findings of the comprehensive assessment.
    (4) The comprehensive assessment, at a minimum, must include the 
following:
    (i) The reasons for the admission.
    (ii) A psychiatric evaluation, completed by a psychiatrist, non-
physician practitioner or psychologist practicing within the scope of 
State licensure that includes the medical history and severity of 
symptoms. Information may be gathered from the client's primary health 
care provider (if any), contingent upon the client's consent.
    (iii) Information concerning previous and current mental status, 
including but not limited to, previous therapeutic interventions and 
hospitalizations.
    (iv) Information regarding the onset of symptoms of the illness and 
circumstances leading to the admission.
    (v) A description of attitudes and behaviors, including cultural and 
environmental factors that may affect the client's treatment plan.
    (vi) An assessment of intellectual functioning, memory functioning, 
and orientation.
    (vii) Complications and risk factors that may affect the care 
planning.
    (viii) Functional status, including the client's ability to 
understand and

[[Page 238]]

participate in his or her own care, and the client's strengths and 
goals.
    (ix) Factors affecting client safety or the safety of others, 
including behavioral and physical factors, as well as suicide risk 
factors.
    (x) A drug profile that includes a review of all of the client's 
prescription and over-the-counter medications; herbal remedies; and 
other alternative treatments or substances that could affect drug 
therapy.
    (xi) The need for referrals and further evaluation by appropriate 
health care professionals, including the client's primary health care 
provider (if any), when warranted.
    (xii) Factors to be considered in discharge planning.
    (xiii) Identification of the client's current social and health care 
support systems.
    (xiv) For pediatric clients, the CMHC must assess the social service 
needs of the client, and make referrals to social services and child 
welfare agencies as appropriate.
    (d) Standard: Update of the comprehensive assessment. (1) The CMHC 
must update each client's comprehensive assessment via the CMHC 
interdisciplinary treatment team, in consultation with the client's 
primary health care provider (if any), when changes in the client's 
status, responses to treatment, or goal achievement have occurred and in 
accordance with current standards of practice.
    (2) For clients that receive PHP services, the assessment must be 
updated no less frequently than every 30 days.
    (3) The update must include information on the client's progress 
toward desired outcomes, a reassessment of the client's response to care 
and therapies, and the client's goals.
    (e) Standard: Discharge or transfer of the client. (1) If the client 
is transferred to another entity, the CMHC must, within 2 working days, 
forward to the entity, a copy of--
    (i) The CMHC discharge summary.
    (ii) The client's clinical record, if requested.
    (2) If a client refuses the services of a CMHC, or is discharged 
from a CMHC due to noncompliance with the treatment plan, the CMHC must 
forward to the primary health care provider (if any) a copy of--
    (i) The CMHC discharge summary.
    (ii) The client's clinical record, if requested.
    (3) The CMHC discharge summary must include--
    (i) A summary of the services provided, including the client's 
symptoms, treatment and recovery goals and preferences, treatments, and 
therapies.
    (ii) The client's current active treatment plan at time of 
discharge.
    (iii) The client's most recent physician orders.
    (iv) Any other documentation that will assist in post-discharge 
continuity of care.
    (4) The CMHC must adhere to all Federal and State-related 
requirements pertaining to the medical privacy and the release of client 
information.

[78 FR 64630, Oct. 29, 2013, as amended at 84 FR 51829, Sept. 30, 2019]



Sec. 485.916  Condition of participation: Treatment team, person-
centered active treatment plan, and coordination of services.

    The CMHC must designate an interdisciplinary treatment team that is 
responsible, with the client, for directing, coordinating, and managing 
the care and services furnished for each client. The interdisciplinary 
treatment team is composed of individuals who work together to meet the 
physical, medical, psychosocial, emotional, and therapeutic needs of 
CMHC clients.
    (a) Standard: Delivery of services. (1) An interdisciplinary 
treatment team, led by a physician, NP, PA, CNS, clinical psychologist, 
or clinical social worker, must provide the care and services offered by 
the CMHC.
    (2) Based on the findings of the comprehensive assessment, the CMHC 
must determine the appropriate licensed mental health professional, who 
is a member of the client's interdisciplinary treatment team, to 
coordinate care and treatment decisions with each client, to ensure that 
each client's needs are assessed, and to ensure that the active 
treatment plan is implemented as indicated.
    (3) The interdisciplinary treatment team may include:

[[Page 239]]

    (i) A doctor of medicine, osteopathy or psychiatry (who is an 
employee of or under contract with the CMHC).
    (ii) A psychiatric registered nurse.
    (iii) A clinical social worker.
    (iv) A clinical psychologist.
    (v) An occupational therapist.
    (vi) Other licensed mental health professionals, as necessary.
    (vii) Other CMHC staff or volunteers, as necessary.
    (4) If the CMHC has more than one interdisciplinary team, it must 
designate the treatment team responsible for establishing policies and 
procedures governing the coordination of services and the day-to-day 
provision of CMHC care and services.
    (b) Standard: Person-centered active treatment plan. All CMHC care 
and services furnished to clients must be consistent with an 
individualized, written, active treatment plan that is established by 
the CMHC interdisciplinary treatment team, the client, and the client's 
primary caregiver(s), in accordance with the client's recovery goals and 
preferences, within 7 working days of admission to the CMHC. The CMHC 
must ensure that each client and the client's primary caregiver(s), as 
applicable, receive education and training provided by the CMHC that are 
consistent with the client's and caregiver's responsibilities as 
identified in the active treatment plan.
    (c) Standard: Content of the person-centered active treatment plan. 
The CMHC must develop a person-centered individualized active treatment 
plan for each client. The active treatment plan must take into 
consideration client recovery goals and the issues identified in the 
comprehensive assessment. The active treatment plan must include all 
services necessary to assist the client in meeting his or her recovery 
goals, including the following:
    (1) Client diagnoses.
    (2) Treatment goals.
    (3) Interventions.
    (4) A detailed statement of the type, duration, and frequency of 
services, including social work, psychiatric nursing, counseling, and 
therapy services, necessary to meet the client's specific needs.
    (5) Drugs, treatments, and individual and/or group therapies.
    (6) Family psychotherapy with the primary focus on treatment of the 
client's conditions.
    (7) The interdisciplinary treatment team's documentation of the 
client's or representative's and primary caregiver's (if any) 
understanding, involvement, and agreement with the plan of care, in 
accordance with the CMHC's policies.
    (d) Standard: Review of the person-centered active treatment plan. 
The CMHC interdisciplinary treatment team must review, revise, and 
document the individualized active treatment plan as frequently as the 
client's condition requires, but no less frequently than every 30 
calendar days. A revised active treatment plan must include information 
from the client's initial evaluation and comprehensive assessments, the 
client's progress toward outcomes and goals specified in the active 
treatment plan, and changes in the client's goals. The CMHC must also 
meet partial hospitalization program requirements specified under Sec. 
424.24(e) of this chapter if such services are included in the active 
treatment plan.
    (e) Standard: Coordination of services. The CMHC must develop and 
maintain a system of communication that assures the integration of 
services in accordance with its policies and procedures and, at a 
minimum, would do the following:
    (1) Ensure that the interdisciplinary treatment team maintains 
responsibility for directing, coordinating, and supervising the care and 
services provided.
    (2) Ensure that care and services are provided in accordance with 
the active treatment plan.
    (3) Ensure that the care and services provided are based on all 
assessments of the client.
    (4) Provide for and ensure the ongoing sharing of information among 
all disciplines providing care and services, whether the care and 
services are provided by employees or those under contract with the 
CMHC.
    (5) Provide for ongoing sharing of information with other health 
care and non-medical providers, including the

[[Page 240]]

primary health care provider, furnishing services to a client for 
conditions unrelated to the psychiatric condition for which the client 
has been admitted, and non-medical supports addressing environmental 
factors such as housing and employment.



Sec. 485.917  Condition of participation: Quality assessment and
performance improvement.

    The CMHC must develop, implement, and maintain an effective, 
ongoing, CMHC-wide data-driven quality assessment and performance 
improvement program (QAPI). The CMHC's governing body must ensure that 
the program reflects the complexity of its organization and services, 
involves all CMHC services (including those services furnished under 
contract or arrangement), focuses on indicators related to improved 
behavioral health or other healthcare outcomes, and takes actions to 
demonstrate improvement in CMHC performance. The CMHC must maintain 
documentary evidence of its quality assessment and performance 
improvement program and be able to demonstrate its operation to CMS.
    (a) Standard: Program scope. (1) The CMHC program must be able to 
demonstrate measurable improvement in indicators related to improving 
behavioral health outcomes and CMHC services.
    (2) The CMHC must measure, analyze, and track quality indicators; 
adverse client events, including the use of restraint and seclusion; and 
other aspects of performance that enable the CMHC to assess processes of 
care, CMHC services, and operations.
    (b) Standard: Program data. (1) The program must use quality 
indicator data, including client care, and other relevant data, in the 
design of its program.
    (2) The CMHC must use the data collected to do the following:
    (i) Monitor the effectiveness and safety of services and quality of 
care.
    (ii) Identify opportunities and priorities for improvement.
    (3) The frequency and detail of the data collection must be approved 
by the CMHC's governing body.
    (c) Standard: Program activities. (1) The CMHC's performance 
improvement activities must:
    (i) Focus on high risk, high volume, or problem-prone areas.
    (ii) Consider incidence, prevalence, and severity of problems.
    (iii) Give priority to improvements that affect behavioral outcomes, 
client safety, and person-centered quality of care.
    (2) Performance improvement activities must track adverse client 
events, analyze their causes, and implement preventive actions and 
mechanisms that include feedback and learning throughout the CMHC.
    (3) The CMHC must take actions aimed at performance improvement and, 
after implementing those actions, the CMHC must measure its success and 
track performance to ensure that improvements are sustained.
    (d) Standard: Performance improvement projects. CMHCs must develop, 
implement and evaluate performance improvement projects.
    (1) The number and scope of distinct performance improvement 
projects conducted annually, based on the needs of the CMHC's population 
and internal organizational needs, must reflect the scope, complexity, 
and past performance of the CMHC's services and operations.
    (2) The CMHC must document what performance improvement projects are 
being conducted, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.
    (e) Standard: Executive responsibilities. The CMHC's governing body 
is responsible for ensuring the following:
    (1) That an ongoing QAPI program for quality improvement and client 
safety is defined, implemented, maintained, and evaluated annually.
    (2) That the CMHC-wide quality assessment and performance 
improvement efforts address priorities for improved quality of care and 
client safety, and that all improvement actions are evaluated for 
effectiveness.
    (3) That one or more individual(s) who are responsible for operating 
the QAPI program are designated.

[[Page 241]]



Sec. 485.918  Condition of participation: Organization, governance, 
administration of services, and partial hospitalization services.

    The CMHC must organize, manage, and administer its resources to 
provide CMHC services, including specialized services for children, 
elderly individuals, individuals with serious mental illness, and 
residents of its mental health service area who have been discharged 
from an inpatient mental health facility.
    (a) Standard: Governing body and administrator. (1) A CMHC must have 
a designated governing body made up of two or more designated persons, 
one of which may be the administrator, that assumes full legal authority 
and responsibility for the management of the CMHC, the services it 
furnishes, its fiscal operations, and continuous quality improvement. 
One member of the governing body must possess knowledge and experience 
as a mental health clinician.
    (2) The CMHC's governing body must appoint an administrator who 
reports to the governing body and is responsible for the day-to-day 
operation of the CMHC. The administrator must be a CMHC employee and 
meet the education and experience requirements established by the CMHC's 
governing body.
    (b) Standard: Provision of services. (1) A CMHC must be primarily 
engaged in providing the following care and services to all clients 
served by the CMHC regardless of payer type, and must do so in a manner 
that is consistent with the following accepted standards of practice:
    (i) Provides outpatient services, including specialized outpatient 
services for children, elderly individuals, individuals with serious 
mental illness, and residents of its mental health service area who have 
been discharged from inpatient mental health facilities.
    (ii) Provides 24-hour-a-day emergency care services.
    (iii) Provides day treatment, partial hospitalization services other 
than in an individual's home or in an inpatient or residential setting, 
or psychosocial rehabilitation services.
    (iv) Provides screening for clients being considered for admission 
to State mental health facilities to determine the appropriateness of 
such services, unless otherwise directed by State law.
    (v) Provides at least 40 percent of its items and services to 
individuals who are not eligible for benefits under title XVIII of the 
Act, as measured by the total number of CMHC clients treated by the CMHC 
for whom services are not paid for by Medicare, divided by the total 
number of clients treated by the CMHC for each 12-month period of 
enrollment.
    (A) A CMHC is required to submit to CMS a certification statement 
provided by an independent entity that certifies that the CMHC's client 
population meets the 40 percent requirement specified at this paragraph 
(b)(1)(v).
    (B) The certification statement described in paragraph (b)(1)(v)(A) 
of this section is required upon initial application to enroll in 
Medicare, and as a part of revalidation, including any off cycle 
revalidation, thereafter carried out pursuant to Sec. 424.530 of this 
chapter. Medicare enrollment will be denied or revoked in instances 
where the CMHC fails to provide the certification statement as required. 
Medicare enrollment will also be denied or revoked if the 40 percent 
requirement as specified in this paragraph (b)(1)(v) is not met.
    (vi) Provides individual and group psychotherapy utilizing a 
psychiatrist, psychologist, or other licensed mental health counselor, 
to the extent authorized under State law.
    (vii) Provides physician services.
    (viii) Provides psychiatric nursing services.
    (ix) Provides clinical social work services.
    (x) Provides family counseling services, with the primary purpose of 
treating the individual's condition.
    (xi) Provides occupational therapy services.
    (xii) Provides services of other staff trained to work with 
psychiatric clients.
    (xiii) Provides drugs and biologicals furnished for therapeutic 
purposes that cannot be self-administered.
    (xiv) Provides client training and education as related to the 
individual's care and active treatment.

[[Page 242]]

    (xv) Provides individualized therapeutic activity services that are 
not primarily recreational or diversionary.
    (xvi) Provides diagnostic services.
    (2) The CMHC and individuals furnishing services on its behalf must 
meet applicable State licensing and certification requirements.
    (c) Standard: Professional management responsibility. A CMHC that 
has a written agreement with another agency, individual, or organization 
to furnish any services under arrangement must retain administrative and 
financial management and oversight of staff and services for all 
arranged services. As part of retaining financial management 
responsibility, the CMHC must retain all payment responsibility for 
services furnished under arrangement on its behalf. Arranged services 
must be supported by a written agreement which requires that all 
services be as follows:
    (1) Authorized by the CMHC.
    (2) Furnished in a safe and effective manner.
    (3) Delivered in accordance with established professional standards, 
the policies of the CMHC, and the client's active treatment plan.
    (d) Standard: Staff training. (1) A CMHC must provide education 
about CMHC care and services, and person-centered care to all employees, 
volunteers, and staff under contract who have contact with clients and 
their families.
    (2) A CMHC must provide an initial orientation for each individual 
furnishing services that addresses the specific duties of his or her 
job.
    (3) A CMHC must assess the skills and competence of all individuals 
furnishing care and, as necessary, provide in-service training and 
education programs where indicated. The CMHC must have written policies 
and procedures describing its method(s) of assessing competency and must 
maintain a written description of the in-service training provided 
during the previous 12 months.
    (e) Standard: Physical environment--(1) Environmental conditions. 
The CMHC must provide a safe, functional, sanitary, and comfortable 
environment for clients and staff that is conducive to the provision of 
services that are identified in paragraph (b) of this section.
    (2) Building. The CMHC services must be provided in a location that 
meets Federal, State, and local health and safety standards and State 
health care occupancy regulations.
    (3) Infection control. There must be policies, procedures, and 
monitoring for the prevention, control, and investigation of infection 
and communicable diseases with the goal of avoiding sources and 
transmission of infection.
    (4) Therapy sessions. The CMHC must ensure that individual or group 
therapy sessions are conducted in a manner that maintains client privacy 
and ensures client dignity.
    (f) Standard: Partial hospitalization services. A CMHC providing 
partial hospitalization services must--
    (1) Provide services as defined in Sec. 410.2 of this chapter.
    (2) Provide the services and meet the requirements specified in 
Sec. 410.43 of this chapter.
    (3) Meet the requirements for coverage as described in Sec. 410.110 
of this chapter.
    (4) Meet the content of certification and plan of treatment 
requirements as described in Sec. 424.24(e) of this chapter.
    (g) Standard: Compliance with Federal, State, and local laws and 
regulations related to the health and safety of clients. The CMHC and 
its staff must operate and furnish services in compliance with all 
applicable Federal, State, and local laws and regulations related to the 
health and safety of clients. If State or local law provides for 
licensing of CMHCs, the CMHC must be licensed. The CMHC staff must 
follow the CMHC's policies and procedures.



Sec. 485.920  Condition of participation: Emergency preparedness.

    The Community Mental Health Center (CMHC) must comply with all 
applicable Federal, State, and local emergency preparedness 
requirements. The CMHC 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 CMHC must develop and maintain an emergency

[[Page 243]]

preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address client population, including, but not limited to, the 
type of services the CMHC 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 CMHC 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) A system to track the location of on-duty staff and sheltered 
clients in the CMHC's care during and after an emergency. If on-duty 
staff and sheltered clients are relocated during the emergency, the CMHC 
must document the specific name and location of the receiving facility 
or other location.
    (2) Safe evacuation from the CMHC, 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.
    (3) A means to shelter in place for clients, staff, and volunteers 
who remain in the facility.
    (4) A system of medical documentation that preserves client 
information, protects confidentiality of client information, and secures 
and maintains the availability of records.
    (5) 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.
    (6) The development of arrangements with other CMHCs or other 
providers to receive clients in the event of limitations or cessation of 
operations to maintain the continuity of services to CMHC clients.
    (7) The role of the CMHC under a waiver declared by the Secretary of 
Health and Human Services, in accordance with section 1135 of the Social 
Security Act, in the provision of care and treatment at an alternate 
care site identified by emergency management officials.
    (c) Communication plan. The CMHC 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) Clients' physicians.
    (iv) Other CMHCs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) CMHC's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
clients under the CMHC'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 client 
information as permitted under 45 CFR 164.510(b)(1)(ii).

[[Page 244]]

    (6) A means of providing information about the general condition and 
location of clients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the CMHC's needs, and its 
ability to provide assistance, to the authority having jurisdiction or 
the Incident Command Center, or designee.
    (d) Training and testing. The CMHC 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. If the emergency 
preparedness policies and procedures are significantly updated, the CMHC 
must conduct training on the updated policies and procedures.
    (1) Training. The CMHC must 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, and maintain documentation of the 
training. The CMHC must demonstrate staff knowledge of emergency 
procedures. Thereafter, the CMHC must provide emergency preparedness 
training at least every 2 years.
    (2) Testing. The CMHC must conduct exercises to test the emergency 
plan at least annually. The CMHC must:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, conduct an 
individual, facility-based every 2 years; or.
    (B) If the CMHC experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CMHC is exempt from 
engaging in its next required 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 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 CMHC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CMHC's emergency plan, as needed.
    (e) Integrated healthcare systems. If a CMHC 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 CMHC may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of 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.
    (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 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.

[[Page 245]]

    (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 64039, Sept. 16, 2016, as amended at 84 FR 51829, Sept. 30, 2019]



PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS--Table of Contents



                      Subpart A_General Provisions

Sec.
486.1 Basis and scope.

Subpart B [Reserved]

       Subpart C_Conditions for Coverage: Portable X-Ray Services

486.100 Condition for coverage: Compliance with Federal, State, and 
          local laws and regulations.
486.102 Condition for coverage: Supervision by a qualified physician.
486.104 Condition for coverage: Qualifications, orientation, and health 
          of technical personnel.
486.106 Condition for coverage: Referral for service and preservation of 
          records.
486.108 Condition for coverage: Safety standards.
486.110 Condition for coverage: Inspection of equipment.

Subparts D-F [Reserved]

Subpart G_Requirements for Certification and Designation and Conditions 
              for Coverage: Organ Procurement Organizations

486.301 Basis and scope.
486.302 Definitions.

             Requirements for Certification and Designation

486.303 Requirements for certification.
486.304 Requirements for designation.
486.306 OPO service area size designation and documentation 
          requirements.
486.308 Designation of one OPO for each service area.
486.309 Re-certification from August 1, 2006 through July 31, 2010.
486.310 Changes in control or ownership or service area.

                  Re-certification and De-certification

486.312 De-certification.
486.314 Appeals.
486.316 Re-certification and competition processes.

           Organ Procurement Organization Outcome Requirements

486.318 Condition: Outcome measures.

       Organ Procurement Organization Process Performance Measures

486.320 Condition: Participation in Organ Procurement and 
          Transplantation Network.
486.322 Condition: Relationships with hospitals, critical access 
          hospitals, and tissue banks.
486.324 Condition: Administration and governing body.
486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
486.330 Condition: Information management.
486.342 Condition: Requesting consent.
486.344 Condition: Evaluation and management of potential donors and 
          organ placement and recovery.
486.346 Condition: Organ preparation and transport.
486.348 Condition: Quality assessment and performance improvement 
          (QAPI).
486.360 Condition for Coverage: Emergency preparedness.

Subpart H--[Reserved]

       Subpart I_Requirements for Home Infusion Therapy Suppliers

                           General Provisions

486.500 Basis and scope.
486.505 Definitions.

                   Standards for Home Infusion Therapy

486.520 Plan of care.
486.525 Required services.

    Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.



                      Subpart A_General Provisions



Sec. 486.1  Basis and scope.

    (a) Statutory basis. This part is based on the following sections of 
the Act:


[[Page 246]]


    1102 and 1138(b), 1871 of the Social Security Act, section 371(b) of 
the Public Health Service Act--for coverage of organ procurement 
services.
    1861(p)--for coverage of outpatient physical therapy services 
furnished by physical therapists in independent practice.
    1861(s) (3), (15), and (17)--for coverage of portable X-ray 
services.

    (b) Scope. (1) This part sets forth the conditions for coverage of 
certain specialized services that are furnished by suppliers and that 
are not specified in other portions of this chapter.
    (2) The conditions for coverage of other specialized services 
furnished by suppliers are set forth in the following regulations which, 
unless otherwise indicated, are part of this chapter:
    (i) Ambulatory surgical center (ASC) services--Part 416.
    (ii) Ambulance services--Part 410, subpart B.
    (iii) ESRD services--Part 405, subpart U.
    (iv) Laboratory services--Part 493.
    (v) Mammography services--Part 410, subpart B (Sec. 410.34) and 21 
CFR part 900, subpart B, of the Food and Drug Administration 
regulations.
    (vi) Rural health clinic and Federally qualified health center 
services--Part 491, subpart A.

[60 FR 50447, Sept. 29, 1995, as amended at 71 FR 31046, May 31, 2006]

Subpart B [Reserved]



       Subpart C_Conditions for Coverage: Portable X-Ray Services

    Authority: Secs. 1102, 1861(s) (3), (11) and (12), 1864, and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1395x(s) (3), (11), and (12), 
1395aa and 1395hh).

    Source: 34 FR 388, Jan. 10, 1969, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977, and further redesignated 
and amended at 60 FR 2326, Jan. 9, 1995.



Sec. 486.100  Condition for coverage: Compliance with Federal, State,
and local laws and regulations.

    The supplier of portable X-ray services is in conformity with all 
applicable Federal, State, and local laws and regulations.
    (a) Standard--licensure or registration of supplier. In any State in 
which State or applicable local law provides for the licensure or 
registration of suppliers of X-ray services, the supplier is (1) 
licensed or registered pursuant to such law, or (2) approved by the 
agency of the State or locality responsible for licensure or 
registration as meeting the standards established for such licensure or 
registration.
    (b) Standard--licensure or registration of personnel. All personnel 
engaged in operating portable X-ray equipment are currently licensed or 
registered in accordance with all applicable State and local laws.
    (c) Standard--licensure or registration of equipment. All portable 
X-ray equipment used in providing portable X-ray services is licensed or 
registered in accordance with all applicable State and local laws.
    (d) Standard--conformity with other Federal, State, and local laws 
and regulations. The supplier of portable X-ray services agrees to 
render such services in conformity with Federal, State, and local laws 
relating to safety standards.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec. 486.102  Condition for coverage: Supervision by a qualified
physician.

    Portable X-ray services are provided under the supervision of a 
qualified physician.
    (a) Standard--physician supervision. The performance of the 
roentgenologic procedures is subject to the supervision of a physician 
who meets the requirements of paragraph (b) of this section and one of 
the following requirements is met:
    (1) The supervising physician owns the equipment and it is operated 
only by his employees, or
    (2) The supervising physician certifies annually that he 
periodically checks the procedural manuals and observes the operators' 
performance, that he has verified that equipment and personnel meet 
applicable Federal, State, and local licensure and registration 
requirements and that safe operating procedures are used.

[[Page 247]]

    (b) Standard--qualifications of the physician supervisor. Portable 
X-ray services are provided under the supervision of a licensed doctor 
of medicine or licensed doctor of osteopathy who is qualified by 
advanced training and experience in the use of X-rays for diagnostic 
purposes, i.e., he (1) is certified in radiology by the American Board 
of Radiology or by the American Osteopathic Board of Radiology or 
possesses qualifications which are equivalent to those required for such 
certification, or (2) is certified or meets the requirements for 
certification in a medical specialty in which he has become qualified by 
experience and training in the use of X-rays for diagnostic purposes, or 
(3) specializes in radiology and is recognized by the medical community 
as a specialist in radiology.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec. 486.104  Condition for coverage: Qualifications, orientation
and health of technical personnel.

    Portable X-ray services are provided by qualified technologists.
    (a) Standard: Qualifications of technologists. All operators of the 
portable X-ray equipment meet the requirements of paragraph (a)(1) or 
(2) of this section.
    (1) Successful completion of a program of formal training in X-ray 
technology at which the operator received appropriate training and 
demonstrated competence in the use of equipment and administration of 
portable x-ray procedures; or
    (2) Successful completion of 24 full months of training and 
experience under the direct supervision of a physician who is certified 
in radiology or who possesses qualifications which are equivalent to 
those required for such certification.
    (b) Standard--personnel orientation. The supplier of portable X-ray 
services has an orientation program for personnel, based on a procedural 
manual which is: Available to all members of the staff, incorporates 
relevant portions of professionally recognized documents, and includes 
instruction in all of the following:
    (1) Precautions to be followed to protect the patient from 
unnecessary exposure to radiation;
    (2) Precautions to be followed to protect an individual supporting 
the patient during X-ray procedures from unnecessary exposure to 
radiation;
    (3) Precautions to be followed to protect other individuals in the 
surrounding environment from exposure to radiation;
    (4) Precautions to be followed to protect the operator of portable 
X-ray equipment from unnecessary exposure to radiation;
    (5) Considerations in determining the area which will receive the 
primary beam;
    (6) Determination of the time interval at which to check personnel 
radiation monitors;
    (7) Use of the personnel radiation monitor in providing an 
additional check on safety of equipment;
    (8) Proper use and maintenance of equipment;
    (9) Proper maintenance of records;
    (10) Technical problems which may arise and methods of solution;
    (11) Protection against electrical hazards;
    (12) Hazards of excessive exposure to radiation.
    (c) Standard: Employee records. Records are maintained and include 
evidence that--
    (1) Each employee is qualified for his or her position by means of 
training and experience; and
    (2) Employees receive adequate health supervision.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988; 60 FR 45086, Aug. 30, 1995; 
73 FR 69942, Nov. 19, 2008; 84 FR 51830, Sept. 30, 2019]



Sec. 486.106  Condition for coverage: Referral for service and 
preservation of records.

    All portable X-ray services performed for Medicare beneficiaries are 
ordered by a physician or a nonphysician practitioner as provided in 
Sec. 410.32(a) of this chapter or by a nonphysician practitioner as 
provided in Sec. 410.32(a)(2) and records are properly preserved.
    (a) Standard--referral by a physician or nonphysician practitioners. 
Portable X-

[[Page 248]]

ray examinations are performed only on the order of a physician licensed 
to practice in the State or by a nonphysician practitioner acting within 
the scope of State law. Such nonphysician practitioners may be treated 
the same as physicians treating beneficiaries for the purpose of this 
paragraph. The supplier's records show that:
    (1) The portable X-ray test was ordered by a licensed physician or a 
nonphysician practitioner acting within the State scope of law; and
    (2) Such physician or non-physician practitioner's order meets the 
requirements at Sec. 410.32 of this chapter, and includes a statement 
concerning the condition of the patient which indicates why portable X-
ray services are necessary.
    (b) Standard--records of examinations performed. The supplier makes 
for each patient a record of the date of the portable X-ray examination, 
the name of the patient, a description of the procedures ordered and 
performed, the referring physician or nonphysician practitioner, the 
operator(s) of the portable X-ray equipment who performed the 
examination, the physician to whom the radiograph was sent, and the date 
it was sent.
    (c) Standard--preservation of records. Such reports are maintained 
for a period of at least 2 years, or for the period of time required by 
State law for such records (as distinguished from requirements as to the 
radiograph itself), whichever is longer.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995; 77 FR 69372, Nov. 16, 2012; 84 FR 51830, Sept. 30, 
2019]



Sec. 486.108  Condition for coverage: Safety standards.

    X-ray examinations are conducted through the use of equipment which 
is free of unnecessary hazards for patients, personnel, and other 
persons in the immediate environment, and through operating procedures 
which provide minimum radiation exposure to patients, personnel, and 
other persons in the immediate environment.
    (a) Standard--tube housing and devices to restrict the useful beam. 
The tube housing is of diagnostic type. Diaphragms, cones, or adjustable 
collimators capable of restricting the useful beam to the area of 
clinical interest are used and provide the same degree of protection as 
is required of the housing.
    (b) Standard--total filtration. (1) The aluminum equivalent of the 
total filtration in the primary beam is not less than that shown in the 
following table except when contraindicated for a particular diagnostic 
procedure.

------------------------------------------------------------------------
                                             Total filtration (inherent
              Operating kVp                         plus added)
------------------------------------------------------------------------
Below 50 kVp.............................  0.5 millimeters aluminum.
50-70 kVp................................  1.5 millimeters aluminum.
Above 70 kVp.............................  2.5 millimeters aluminum.
------------------------------------------------------------------------

    (2) If the filter in the machine is not accessible for examination 
or the total filtration is unknown, it can be assumed that the 
requirements are met if the half-value layer is not less than that shown 
in the following table:

------------------------------------------------------------------------
              Operating kVp                       Half-value layer
------------------------------------------------------------------------
50 kVp...................................  0.6 millimeters aluminum.
70 kVp...................................  1.6 millimeters aluminum.
90 kVp...................................  2.6 millimeters aluminum.
100 kVp..................................  2.8 millimeters aluminum.
110 kVp..................................  3.0 millimeters aluminum.
120 kVp..................................  3.3 millimeters aluminum.
------------------------------------------------------------------------

    (c) Standard--termination of exposure. A device is provided to 
terminate the exposure after a preset time or exposure.
    (d) Standard--control panel. The control panel provides a device 
(usually a milliammeter or a means for an audible signal to give 
positive indication of the production of X-rays whenever the X-ray tube 
is energized. The control panel includes appropriate indicators 
(labelled control settings and/or meters) which show the physical 
factors (such as kVp, mA, exposure time or whether timing is automatic) 
used for the exposure.
    (e) Standard--exposure control switch. The exposure control switch 
is of the dead-man type and is so arranged that the operator can stand 
at least 6 feet from the patient and well away from the useful beam.
    (f) Standard--protection against electrical hazards. Only shockproof 
equipment is used. All electrical equipment is grounded.

[[Page 249]]

    (g) Standard--mechanical supporting or restraining devices. 
Mechanical supporting or restraining devices are provided so that such 
devices can be used when a patient must be held in position for 
radiography.
    (h) Standard--protective gloves and aprons. Protective gloves and 
aprons are provided so that when the patient must be held by an 
individual, that individual is protected with these shielding devices.
    (i) Standard--restriction of the useful beam. Diaphragms, cones, or 
adjustable collimators are used to restrict the useful beam to the area 
of clinical interest.
    (j) Standard--personnel monitoring. A device which can be worn to 
monitor radiation exposure (e.g., a film badge) is provided to each 
individual who operates portable X-ray equipment. The device is 
evaluated for radiation exposure to the operator at least monthly and 
appropriate records are maintained by the supplier of portable X-ray 
services of radiation exposure measured by such a device for each 
individual.
    (k) Standard--personnel and public protection. No individual 
occupationally exposed to radiation is permitted to hold patients during 
exposures except during emergencies, nor is any other individual 
regularly used for this service. Care is taken to assure that pregnant 
women do not assist in portable X-ray examinations.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec. 486.110  Condition for coverage: Inspection of equipment.

    Inspections of all X-ray equipment and shielding are made by 
qualified individuals at intervals not greater than every 24 months.
    (a) Standard--qualified inspectors. Inspections are made at least 
every 24 months by a radiation health specialist who is on the staff of 
or approved by an appropriate State or local government agency.
    (b) Standard--records of inspection and scope of inspection. The 
supplier maintains records of current inspections which include the 
extent to which equipment and shielding are in compliance with the 
safety standards outlined in Sec. 486.108.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995; 60 FR 50447, Sept. 29, 1995]

Subparts D-F [Reserved]



Subpart G_Requirements for Certification and Designation and Conditions 
              for Coverage: Organ Procurement Organizations

    Source: 71 FR 31046, May 31, 2006, unless otherwise noted.



Sec. 486.301  Basis and scope.

    (a) Statutory basis. (1) Section 1138(b) of the Act sets forth the 
requirements that an organ procurement organization (OPO) must meet to 
have its organ procurement services to hospitals covered under Medicare 
and Medicaid. These include certification as a ``qualified'' OPO and 
designation as the OPO for a particular service area.
    (2) Section 371(b) of the Public Health Service Act sets forth the 
requirements for certification and the functions that a qualified OPO is 
expected to perform.
    (3) Section 1102 of the Act authorizes the Secretary of Health and 
Human Services to make and publish rules and regulations necessary to 
the efficient administration of the functions that are assigned to the 
Secretary under the Act.
    (4) Section 1871 of the Act authorizes the Secretary to prescribe 
regulations as may be necessary to carry out the administration of the 
Medicare program under title XVIII.
    (b) Scope. This subpart sets forth--
    (1) The conditions and requirements that an OPO must meet;
    (2) The procedures for certification and designation of OPOs; and
    (3) The terms of the agreement with CMS and the basis for and the 
effect of de-certification.
    (4) The requirements for an OPO to be re-certified.



Sec. 486.302  Definitions.

    As used in this subpart, the following definitions apply:

[[Page 250]]

    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury or the risk 
thereof. As applied to OPOs, adverse events include but are not limited 
to transmission of disease from a donor to a beneficiary, avoidable loss 
of a medically suitable potential donor for whom consent for donation 
has been obtained, or delivery to a transplant center of the wrong organ 
or an organ whose blood type does not match the blood type of the 
intended beneficiary.
    Agreement cycle refers to the time period of at least 4 years when 
an agreement is in effect between CMS and an OPO.
    Assessment period is a 12-month period in which an OPO's outcome 
measures will be evaluated for performance. The final assessment period 
is the 12-month assessment period used to calculate outcome measures for 
re-certification.
    Certification means a CMS determination that an OPO meets the 
requirements for certification at Sec. 486.303.
    Death record review means an assessment of the medical chart of a 
deceased patient to evaluate potential for organ donation.
    Death that is consistent with organ donation means all deaths from 
the state death certificates with the primary cause of death listed as 
the ICD-10-CM codes I20-I25 (ischemic heart disease); I60-I69 
(cerebrovascular disease); V-1-Y89 (external causes of death): Blunt 
trauma, gunshot wounds, drug overdose, suicide, drowning, and 
asphyxiation.
    Decertification means a CMS determination that an OPO no longer 
meets the requirements for certification at Sec. 486.303.
    Designated requestor or effective requestor is an individual 
(generally employed by a hospital), who is trained to handle or 
participate in the donation consent process. The designated requestor 
may request consent for donation from the family of a potential donor or 
from the individual(s) responsible for making the donation decision in 
circumstances permitted under State law, provide information about 
donation to the family or decision-maker(s), or provide support to or 
collaborate with the OPO in the donation consent process.
    Designation means CMS assignment of a geographic service area to an 
OPO. Once an OPO is certified and assigned a geographic service area, 
organ procurement costs of the OPO are eligible for Medicare and 
Medicaid payment under section 1138(b)(1)(F) of the Act.
    Donation rate is the number of donors as a percentage of the donor 
potential.
    Donation service area (DSA) means a geographical area of sufficient 
size to ensure maximum effectiveness in the procurement and equitable 
distribution of organs and that either includes an entire metropolitan 
statistical area or does not include any part of such an area and that 
meets the standards of this subpart.
    Donor means a deceased individual from whom at least one 
vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) 
is recovered for the purpose of transplantation.
    Donor after cardiac death (DCD) means an individual who donates 
after his or her heart has irreversibly stopped beating. A donor after 
cardiac death may be termed a non-heartbeating or asystolic donor.
    Donor document means any documented indication of an individual's 
choice regarding his or her wishes concerning organ and/or tissue 
donation that was made by that individual or another authorized 
individual in accordance with any applicable State law.''
    Donor potential is the number of inpatient deaths within the DSA 
among patients 75 and younger with a primary cause of death that is 
consistent with organ donation. For OPOs servicing a hospital with a 
waiver under Sec. 486.308(e), the donor potential of the county for 
that hospital will be adjusted using the proportion of Medicare 
beneficiary inpatient deaths in the hospital compared with the total 
Medicare beneficiary inpatient deaths in the county.
    Eligible death. An eligible death for organ donation means the death 
of a person--
    (1) Who is 75 years old or younger;
    (2) Who is legally declared dead by neurologic criteria in 
accordance with State or local law;

[[Page 251]]

    (3) Whose body weight is 5 kg or greater;
    (4) Whose body mass Index (BMI) is 50 kg/m2 or less;
    (5) Who had at least one kidney, liver, heart, or lung that is 
deemed to meet the eligible data definition as follows:
    (i) The kidney would be initially deemed to meet the eligible data 
definition unless the donor meets one of the following:
    (A) Is more than 70 years of age;
    (B) Is age 50-69 years with history of Type 1 diabetes for more than 
20 years;
    (C) Has polycystic kidney disease;
    (D) Has glomerulosclerosis equal to or more than 20 percent by 
kidney biopsy;
    (E) Has terminal serum creatinine greater than 4/0 mg/dl;
    (F) Has chronic renal failure; or
    (G) Has no urine output for at least or more than 24 hours;
    (ii) The liver would be initially deemed to meet the eligible data 
definition unless the donor has one of the following:
    (A) Cirrhosis;
    (B) Terminal total bilirubin equal to or more than 4 mg/dl;
    (C) Portal hypertension;
    (D) Macrosteatosis equal to or more than 50 percent or fibrosis 
equal to or more than stage II;
    (E) Fulminant hepatic failure; or
    (F) Terminal AST/ALT of more than 700 U/L.
    (iii) The heart would be initially deemed to meet the eligible data 
definition unless the donor meets one of the following:
    (A) Is more than 60 years of age;
    (B) Is at least or more than 45 years of age with a history of at 
least or more than 10 years of HTN or at least or more than 10 years of 
type 1 diabetes;
    (C) Has a history of Coronary Artery Bypass Graft (CABG);
    (D) Has a history of coronary stent/intervention;
    (E) Has a current or past medical history of myocardial infarction 
(MI);
    (F) Has a severe vessel diagnosis as supported by cardiac 
catheterization (that is more than 50 percent occlusion or 2+ vessel 
disease);
    (G) Has acute myocarditis and/or endocarditis;
    (H) Has heart failure due to cardiomyopathy;
    (I) Has an internal defibrillator or pacemaker;
    (J) Has moderate to severe single valve or 2-valve disease 
documented by echo or cardiac catheterization, or previous valve repair;
    (K) Has serial echo results showing severe global hypokinesis;
    (L) Has myxoma; or
    (M) Has congenital defects (whether surgically corrected or not).
    (iv) The lung would be initially deemed to meet the eligible data 
definition unless the donor meets one of the following:
    (A) Is more than 65 years of age;
    (B) Is diagnosed with coronary obstructive pulmonary disease (COPD) 
(for example, emphysema);
    (C) Has terminal PaO2/FiO2 less than 250 mmHg;
    (D) Has asthma (with daily prescription);
    (E) Asthma is the cause of death;
    (F) Has pulmonary fibrosis;
    (G) Has previous lobectomy;
    (H) Has multiple blebs documented on Computed Axial Tomography (CAT) 
Scan;
    (I) Has pneumonia as indicated on Computed Tomography (CT), X-ray, 
bronchoscopy, or cultures;
    (J) Has bilateral severe pulmonary contusions as per CT.
    (6) If a deceased person meets the criteria specified in paragraphs 
(1) through (5) of this definition, the death of the person would be 
classified as an eligible death, unless the donor meets any of the 
following criteria:
    (i) The donor was taken to the operating room with the intent for 
the OPO to recover organs for transplant and all organs were deemed not 
medically suitable for transplantation; or
    (ii) The donor exhibits any of the following active infections 
(specific diagnoses) of--
    (A) Bacterial: Tuberculosis, Gangrenous bowel or perforated bowel or 
intra-abdominal sepsis;
    (B) Viral: HIV infection by serologic or molecular detection, 
Rabies, Reactive Hepatitis B Surface Antigen, Retroviral infections 
including Viral

[[Page 252]]

Encephalitis or Meningitis, Active Herpes simplex, varicella zoster, or 
cytomegalovirus viremia or pneumonia, Acute Epstein Barr Virus 
(mononucleosis), West Nile (c) Virus infection, SARS, except as provided 
in paragraph (8) of this definition.
    (C) Fungal: Active infection with Cryptococcus, Aspergillus, 
Histoplasma, Coccidioides, Active candidemia or invasive yeast 
infection;
    (D) Parasites: Active infection with Trypanosoma cruzi (Chagas'), 
Leishmania, Strongyloides, or Malaria (Plasmodium sp.); or
    (E) Prion: Creutzfeldt-Jacob Disease.
    (7) The following are general exclusions:
    (i) Aplastic anemia, Agranulocytosis;
    (ii) Current malignant neoplasms except non-melanoma skin cancers 
such as basal cell and squamous cell cancer and primary CNS tumors 
without evident metastatic disease;
    (iii) Previous malignant neoplasms with current evident metastatic 
disease;
    (iv) A history of melanoma;
    (v) Hematologic malignancies: Leukemia, Hodgkin's Disease, Lymphoma, 
Multiple Myeloma;
    (vi) Active Fungal, Parasitic, Viral, or Bacterial Meningitis or 
Encephalitis; and
    (vii) No discernable cause of death.
    (8) Notwithstanding paragraph (6)(ii)(B) of this definition, an HIV 
positive organ procured for the purpose of transplantation into an HIV 
positive recipient would be an exception to an active infection rule 
out, consistent with the HIV Organ Policy Equity Act (the Hope Act).
    Eligible donor means any donor that meets the eligible death 
criteria. The number of eligible donors is the numerator of the donation 
rate outcome performance measure.
    Entire metropolitan statistical area means a metropolitan 
statistical area (MSA), a consolidated metropolitan statistical area 
(CMSA), or a primary metropolitan statistical area (PMSA) listed in the 
State and Metropolitan Area Data Book published by the U.S. Bureau of 
the Census. CMS does not recognize a CMSA as a metropolitan area for the 
purposes of establishing a geographical area for an OPO.
    Expected donation rate means the expected donation rate per 100 
eligible deaths that is the rate expected for an OPO based on the 
national experience for OPOs serving similar eligible donor populations 
and donation service areas. This rate is adjusted for the distributions 
of age, sex, race, and cause of death among eligible deaths.
    Kidney transplantation rate is the number of kidneys transplanted 
from kidney donors in the DSA as a percentage of the donor potential.
    Lowest rate among the top 25 percent will be calculated by taking 
the number of total DSAs in the time period identified for establishing 
the threshold rate. The total number of DSAs will be multiplied by 0.25 
and rounded to the closest integer (0.5 will round to the higher 
integer). The donation rates and organ transplantation rates in each DSA 
will be separately ranked and the threshold rate will be the rate that 
corresponds to that integer when counting down the ranking.
    Observed donation rate is the number of donors meeting the 
eligibility criteria per 100 deaths.
    Open area means an OPO service area for which CMS has notified the 
public that it is accepting applications for designation.
    Organ means a human kidney, liver, heart, lung, pancreas, or 
intestine (or multivisceral organs when transplanted at the same time as 
an intestine).
    Organ procurement organization (OPO) means an organization that 
performs or coordinates the procurement, preservation, and transport of 
organs and maintains a system for locating prospective beneficiaries for 
available organs.
    Organ transplantation rate is the number of organs transplanted from 
donors in the DSA as a percentage of the donor potential. Organs 
transplanted into patients on the OPTN waiting list as part of research 
are included in the organ transplantation rate. The organ 
transplantation rate will be risk-adjusted for the average age of the 
donor potential using the following methodology:
    (1) The age groups used for the adjusted transplantation rates are: 
<1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39,

[[Page 253]]

40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-75.
    (2) Calculate a national age-specific transplantation rate for each 
age group.
    An expected transplantation rate for each OPO is calculated as 
[sum](g=1)Gdg*Rg/[sum]gdg, where dg is the number of potential donors in 
the OPO in age group g, Rg is the age-specific national transplantation 
rate in age group g, and [sum]gdg is the OPO's total number of 
individuals in the donor potential. This can be interpreted as the 
overall expected transplantation rate for an OPO if each of its age-
specific transplantation rates were equal to the national age-specific.
    (3) Calculate the age-adjusted organ transplantation rate as (O/
E)*P, where O is the OPO's observed unadjusted transplantation rate, E 
is the expected transplantation rate calculated in Step 2, and P is the 
unadjusted national transplantation rate.
    Re-certification cycle means the 4-year cycle during which an OPO is 
certified.
    Standard criteria donor (SCD) means a donor that meets the 
eligibility criteria for an eligible donor and does not meet the 
criteria to be a donor after cardiac death or expanded criteria donor.
    Transplant hospital means a hospital that provides organ transplants 
and other medical and surgical specialty services required for the care 
of transplant patients. There may be one or more types of organ 
transplant centers operating within the same transplant hospital.
    Urgent need occurs when an OPO's noncompliance with one or more 
conditions for coverage has caused, or is likely to cause, serious 
injury, harm, impairment, or death to a potential or actual donor or an 
organ beneficiary.

[71 FR 31046, May 31, 2006, as amended at 77 FR 29031, May 16, 2012; 81 
FR 79880, Nov. 14, 2016; 84 FR 61492, Nov. 12, 2019; 85 FR 77947, Dec. 
2, 2020]

    Effective Date Note: At 85 FR 77947, Dec. 2, 2020, Sec. 486.302 was 
amended by revising the definition of ``Donor''; removing the 
definitions of ``Eligible death,'' ``Eligible donor,'' ``Expected 
donation rate,'' and ``Observed donation rate''; revising the definition 
of ``Organ''; and removing the definition of ``Standard criteria donor 
(SCD),'' effective July 31, 2022. For the convenience of the user, the 
added and revised text is set forth as follows:



Sec. 486.302  Definitions.

                                * * * * *

    Donor means a deceased individual from whom at least one 
vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) 
is transplanted. An individual also would be considered a donor if only 
the pancreas is procured and is used for research or islet cell 
transplantation.

                                * * * * *

    Organ means a human kidney, liver, heart, lung, pancreas, or 
intestine (or multivisceral organs when transplanted at the same time as 
an intestine). The pancreas counts as an organ even if it is used for 
research or islet cell transplantation.

------------------------------------------------------------------------
                                                              Number of
                        Organ type                             organs
                                                            transplanted
------------------------------------------------------------------------
(1) Right or Left Kidney..................................             1
(2) Right and Left Kidney.................................             2
(3) Double/En-Bloc Kidney.................................             2
(4) Heart.................................................             1
(5) Intestine.............................................             1
(6) Intestine Segment 1 or Segment 2......................             1
(7) Intestine Segment 1 and Segment 2.....................             2
(8) Liver.................................................             1
(9) Liver Segment 1 or Segment 2..........................             1
(10) Liver Segments 1 and Segment 2.......................             2
(11) Right or Left Lung...................................             1
(12) Right and Left Lung..................................             2
(13) Double/En-bloc Lung..................................             2
(14) Pancreas (transplanted whole, research, islet                     1
 transplant)..............................................
(15) Pancreas Segment 1 or Segment 2......................             1
(16) Pancreas Segment 1 and Segment 2.....................             2
------------------------------------------------------------------------

                                * * * * *

             Requirements for Certification and Designation



Sec. 486.303  Requirements for certification.

    In order to be certified as a qualified organ procurement 
organization, an organ procurement organization must:
    (a) Have received a grant under 42 U.S.C. 273(a) or have been 
certified or re-certified by the Secretary within the previous 4 years 
as being a qualified OPO.

[[Page 254]]

    (b) Be a non-profit entity that is exempt from Federal income 
taxation under section 501 of the Internal Revenue Code of 1986.
    (c) Have accounting and other fiscal procedures necessary to assure 
the fiscal stability of the organization, including procedures to obtain 
payment for kidneys and non-renal organs provided to transplant 
hospitals.
    (d) Have an agreement with CMS, as the Secretary's designated 
representative, to be reimbursed under title XVIII for the procurement 
of kidneys.
    (e) Have been re-certified as an OPO under the Medicare program from 
January 1, 2002 through December 31, 2005.
    (f) Have procedures to obtain payment for non-renal organs provided 
to transplant centers.
    (g) Agree to enter into an agreement with any hospital or critical 
access hospital in the OPO's service area, including a transplant 
hospital that requests an agreement.
    (h) Meet the conditions for coverage for organ procurement 
organizations, which include both outcome and process performance 
measures.
    (i) Meet the provisions of titles XI, XVIII, and XIX of the Act, 
section 371(b) of the Public Health Services Act, and any other 
applicable Federal regulations.



Sec. 486.304  Requirements for designation.

    (a) Designation is a condition for payment. Payment may be made 
under the Medicare and Medicaid programs for organ procurement costs 
attributable to payments made to an OPO by a hospital only if the OPO 
has been designated by CMS as an OPO.
    (b) An OPO must be certified as a qualified OPO by CMS under 42 
U.S.C. 273(b) and Sec. 486.303 to be eligible for designation.
    (c) An OPO must enter into an agreement with CMS in order for the 
organ procurement costs attributable to the OPO to be reimbursed under 
Medicare and Medicaid.



Sec. 486.306  OPO service area size designation and documentation 
requirements.

    (a) General documentation requirement. An OPO must make available to 
CMS documentation verifying that the OPO meets the requirements of 
paragraphs (b) and (c) of this section at the time of application and 
throughout the period of its designation.
    (b) Service area designation. The defined service area either 
includes an entire metropolitan statistical area or a New England county 
metropolitan statistical area as specified by the Director of the Office 
of Management and Budget or does not include any part of such an area.
    (c) Service area location and characteristics. An OPO must define 
and document a proposed service area's location through the following 
information:
    (1) The names of counties (or parishes in Louisiana) served or, if 
the service area includes an entire State, the name of the State.
    (2) Geographic boundaries of the service area.
    (3) The number and the names of all hospitals and critical access 
hospitals in the service area that have both a ventilator and an 
operating room.

[71 FR 31046, May 31, 2006, as amended at 79 FR 27156, May 12, 2014]



Sec. 486.308  Designation of one OPO for each service area.

    (a) CMS designates only one OPO per service area. A service area is 
open for competition when the OPO for the service area is de-certified 
and all administrative appeals under Sec. 486.314 are exhausted.
    (b) Designation periods--
    (1) General. An OPO is normally designated for a 4-year agreement 
cycle. The period may be shorter, for example, if an OPO has voluntarily 
terminated its agreement with CMS and CMS selects a successor OPO for 
the balance of the 4-year agreement cycle. In rare situations, a 
designation period may be longer, for example, a designation may be 
extended if additional time is needed to select a successor OPO to 
replace an OPO that has been de-certified.
    (2) Re-Certification. Re-certification must occur not more 
frequently than once every 4 years.
    (c) Unless CMS has granted a hospital a waiver under paragraphs
    (d) through (f) of this section, the hospital must enter into an 
agreement

[[Page 255]]

only with the OPO designated to serve the area in which the hospital is 
located.
    (d) If CMS changes the OPO designated for an area, hospitals located 
in that area must enter into agreements with the newly designated OPO or 
submit a request for a waiver in accordance with paragraph (e) of this 
section within 30 days of notice of the change in designation.
    (e) A hospital may request and CMS may grant a waiver permitting the 
hospital to have an agreement with a designated OPO other than the OPO 
designated for the service area in which the hospital is located. To 
qualify for a waiver, the hospital must submit data to CMS establishing 
that--
    (1) The waiver is expected to increase organ donations; and
    (2) The waiver will ensure equitable treatment of patients listed 
for transplants within the service area served by the hospital's 
designated OPO and within the service area served by the OPO with which 
the hospital seeks to enter into an agreement.
    (f) In making a determination on waiver requests, CMS considers--
    (1) Cost effectiveness;
    (2) Improvements in quality;
    (3) Changes in a hospital's designated OPO due to changes in the 
definitions of metropolitan statistical areas, if applicable; and
    (4) The length and continuity of a hospital's relationship with an 
OPO other than the hospital's designated OPO.
    (g) A hospital may continue to operate under its existing agreement 
with an out-of-area OPO while CMS is processing the waiver request. If a 
waiver request is denied, a hospital must enter into an agreement with 
the designated OPO within 30 days of notification of the final 
determination.

[71 FR 31046, May 31, 2006, as amended at 79 FR 27156, May 12, 2014]



Sec. 486.309  Re-certification from August 1, 2006 through July 31,
2010.

    An OPO will be considered to be re-certified for the period of 
August 1, 2006 through July 31, 2010 if an OPO met the standards to be a 
qualified OPO within a 4-year period ending December 31, 2001 and has an 
agreement with the Secretary that is scheduled to terminate on July 31, 
2006. Agreements based on the August 1, 2006 through July 31, 2010 re-
certification cycle will end on January 31, 2011.



Sec. 486.310  Changes in control or ownership or service area.

    (a) OPO requirements. (1) A designated OPO considering a change in 
control (see Sec. 413.17(b)(3)) or ownership or in its service area 
must notify CMS before putting it into effect. This notification is 
required to ensure that the OPO, if changed, will continue to satisfy 
Medicare and Medicaid requirements. The merger of one OPO into another 
or the consolidation of one OPO with another is considered a change in 
control or ownership.
    (2) A designated OPO considering a change in its service area must 
obtain prior CMS approval. In the case of a service area change that 
results from a change of control or ownership due to merger or 
consolidation, the OPOs must resubmit the information required in an 
application for designation. The OPO must provide information specific 
to the board structure of the new organization, as well as operating 
budgets, financial information, and other written documentation CMS 
determines to be necessary for designation.
    (b) CMS requirements. (1) If CMS finds that the OPO has changed to 
such an extent that it no longer satisfies the requirements for OPO 
designation, CMS may de-certify the OPO and declare the OPO's service 
area to be an open area. An OPO may appeal such a de-certification as 
set forth in Sec. 486.314. The OPO's service area is not opened for 
competition until the conclusion of the administrative appeals process.
    (2) If CMS finds that the changed OPO continues to satisfy the 
requirements for OPO designation, the period of designation of the 
changed OPO is the remaining portion of the 4-year term of the OPO that 
was reorganized. If more than one designated OPO is involved in the 
reorganization, the remaining designation term is the longest of the 
remaining periods unless CMS determines that a shorter period is in the 
best interest of the Medicare and Medicaid programs. The changed

[[Page 256]]

OPO must continue to meet the requirements for certification at Sec. 
486.303 throughout the remaining period.

                  Re-Certification and De-Certification



Sec. 486.312  De-certification.

    (a) Voluntary termination of agreement. If an OPO wishes to 
terminate its agreement, the OPO must send CMS written notice of its 
intention to terminate its agreement and the proposed effective date. 
CMS may approve the proposed date, set a different date no later than 6 
months after the proposed effective date, or set a date less than 6 
months after the proposed effective date if it determines that a 
different date would not disrupt services to the service area. If CMS 
determines that a designated OPO has ceased to furnish organ procurement 
services to its service area, the cessation of services is deemed to 
constitute a voluntary termination by the OPO, effective on a date 
determined by CMS. CMS will de-certify the OPO as of the effective date 
of the voluntary termination.
    (b) Involuntary termination of agreement. During the term of the 
agreement, CMS may terminate an agreement with an OPO if the OPO no 
longer meets the requirements for certification at Sec. 486.303. CMS 
may also terminate an agreement immediately in cases of urgent need, 
such as the discovery of unsound medical practices. CMS will de-certify 
the OPO as of the effective date of the involuntary termination.
    (c) Non-renewal of agreement. CMS will not voluntarily renew its 
agreement with an OPO if the OPO fails to meet the requirements for 
certification at Sec. 486.318, based on findings from the most recent 
re-certification cycle, or the other requirements for certification at 
Sec. 486.303. CMS will de-certify the OPO as of the ending date of the 
agreement.
    (d) Notice to OPO. Except in cases of urgent need, CMS gives written 
notice of de-certification to an OPO at least 90 days before the 
effective date of the de-certification. In cases of urgent need, CMS 
gives written notice of de-certification to an OPO at least 3 calendar 
days prior to the effective date of the de-certification. The notice of 
de-certification states the reasons for de-certification and the 
effective date.
    (e) Public notice. Once CMS approves the date for a voluntary 
termination, the OPO must provide prompt public notice in the service 
area of the date of de-certification and such other information as CMS 
may require. In the case of involuntary termination or nonrenewal of an 
agreement, CMS also provides notice to the public in the service area of 
the date of de-certification. No payment under titles XVIII or XIX of 
the Act will be made with respect to organ procurement costs 
attributable to the OPO on or after the effective date of de-
certification.

[71 FR 31046, May 31, 2006, as amended at 82 FR 38515, Aug. 14, 2017]



Sec. 486.314  Appeals.

    If an OPO's de-certification is due to involuntary termination or 
non-renewal of its agreement with CMS, the OPO may appeal the de-
certification on substantive and procedural grounds.
    (a) Notice of initial determination. CMS mails notice to the OPO of 
an initial de-certification determination. The notice contains the 
reasons for the determination, the effect of the determination, and the 
OPO's right to seek reconsideration.
    (b) Reconsideration. (1) Filing request. If the OPO is dissatisfied 
with the de-certification determination, it has 15 business days from 
receipt of the notice of de-certification to seek reconsideration from 
CMS. The request for reconsideration must state the issues or findings 
of fact with which the OPO disagrees and the reasons for disagreement.
    (2) An OPO must seek reconsideration before it is entitled to seek a 
hearing before a hearing officer. If an OPO does not request 
reconsideration or its request is not made timely, the OPO has no right 
to further administrative review.
    (3) Reconsideration determination. CMS makes a written reconsidered 
determination within 10 business days of receipt of the request for 
reconsideration, affirming, reversing, or modifying the initial 
determination and the findings on which it was based. CMS augments the 
administrative record to

[[Page 257]]

include any additional materials submitted by the OPO, and a copy of the 
reconsideration decision and sends the supplemented administrative 
record to the CMS hearing officer.
    (c) Request for hearing. An OPO dissatisfied with the CMS 
reconsideration decision, must file a request for a hearing before a CMS 
hearing officer within 40 business days of receipt of the notice of the 
reconsideration determination. If an OPO does not request a hearing or 
its request is not received timely, the OPO has no right to further 
administrative review.
    (d) Administrative record. The hearing officer sends the 
administrative record to both parties within 10 business days of receipt 
of the request for a hearing.
    (1) The administrative record consists of, but is not limited to, 
the following:
    (i) Factual findings from the survey(s) on the OPO conditions for 
coverage.
    (ii) Data from the outcome measures.
    (iii) Rankings of OPOs based on the outcome data.
    (iv) Correspondence between CMS and the affected OPO.
    (2) The administrative record will not include any privileged 
information.
    (e) Pre-Hearing conference. At any time before the hearing, the CMS 
hearing officer may call a pre-hearing conference if he or she believes 
that a conference would more clearly define the issues. At the pre-
hearing conference, the hearing officer may establish the briefing 
schedule, sets the hearing date, and addresses other administrative 
matters. The hearing officer will issue an order reflecting the results 
of the pre-hearing conference.
    (f) Date of hearing. The hearing officer sets a date for the hearing 
that is no more than 60 calendar days following the receipt of the 
request for a hearing.
    (g) Conduct of hearing. (1) The hearing is open to both parties, CMS 
and the OPO.
    (2) The hearing officer inquires fully into all the matters at issue 
and receives in evidence the testimony of witnesses and any documents 
that are relevant and material.
    (3) The hearing officer provides the parties with an opportunity to 
enter an objection to the inclusion of any document. The hearing officer 
will consider the objection and will rule on the document's 
admissibility.
    (4) The hearing officer decides the order in which the evidence and 
the arguments of the parties are presented and the conduct of the 
hearing.
    (5) The hearing officer rules on the admissibility of evidence and 
may admit evidence that would be inadmissible under rules applicable to 
court procedures.
    (6) The hearing officer rules on motions and other procedural items.
    (7) The hearing officer regulates the course of the hearing and 
conduct of counsel.
    (8) The hearing officer may examine witnesses.
    (9) The hearing officer takes any action authorized by the rules in 
this subpart.
    (h) Parties' rights. CMS and the OPO may:
    (1) Appear by counsel or other authorized representative, in all 
hearing proceedings.
    (2) Participate in any pre-hearing conference held by the hearing 
officer.
    (3) Agree to stipulations as to facts which will be made a part of 
the record.
    (4) Make opening statements at the hearing.
    (5) Present relevant evidence on the issues at the hearing.
    (6) Present witnesses, who then must be available for cross-
examination, and cross-examine witnesses presented by the other party.
    (7) Present oral arguments at the hearing.
    (i) Hearing officer's decision. The hearing officer renders a 
decision on the appeal of the notice of de-certification within 20 
business days of the hearing.
    (1) Reversal of de-certification. If the hearing officer reverses 
CMS' determination to de-certify an OPO in a case involving the 
involuntary termination of the OPO's agreement, CMS will not terminate 
the OPO's agreement and will not de-certify the OPO.
    (2) De-certification is upheld. If the de-certification 
determination is upheld by the hearing officer, the OPO is de-

[[Page 258]]

certified and it has no further administrative appeal rights.
    (j) Extension of agreement. If there is insufficient time prior to 
expiration of an agreement with CMS to allow for competition of the 
service area and, if necessary, transition of the service area to a 
successor OPO, CMS may choose to extend the OPO's agreement with CMS.
    (k) Effects of de-certification. Medicare and Medicaid payments may 
not be made for organ procurement services the OPO furnishes on or after 
the effective date of de-certification. CMS will then open the de-
certified OPO's service area for competition as set forth in Sec. 
486.316(c).



Sec. 486.316  Re-certification and competition processes.

    (a) Re-certification of OPOs. Based upon performance on the outcome 
measures set forth in Sec. 486.318 and the re-certification survey, 
each OPO will be designated into either Tier 1, Tier 2, or Tier 3. The 
tier in which the OPO is designated will determine whether the OPO is 
re-certified (Tier 1), must compete to retain its DSA (Tier 2), or will 
receive an initial de-certification determination (Tier 3).
    (1) Tier 1. An OPO is re-certified for at least an additional 4 
years, the OPO's DSA is not opened for competition, and the OPO can 
compete for any open DSA if it meets all of the following:
    (i) It has been shown by survey to be in compliance with the 
requirements for certification at Sec. 486.303, including the 
conditions for coverage at Sec. Sec. 486.320 through 486.360; and
    (ii) It meets the outcome requirements as described in Sec. 
486.318(e)(4) for the final assessment period of the agreement cycle.
    (2) Tier 2. An OPO's DSA is open for competition and the OPO is 
eligible to compete to retain its DSA and for any open DSA if it meets 
all of the following:
    (i) It has been shown by survey to be in compliance with the 
requirements for certification at Sec. 486.303, including the 
conditions for coverage at Sec. Sec. 486.320 through 486.360; and
    (ii) It meets the outcome requirements as described in Sec. 
486.318(e)(5) at the final assessment period of the agreement cycle.
    (3) Tier 3. An OPO will receive a notice of de-certification 
determination under Sec. 486.314 and cannot compete for any open DSA if 
it meets either of the following:
    (i) Has been shown by survey to not be in compliance with the 
requirements for certification at Sec. 486.303, including the 
conditions for coverage at Sec. Sec. 486.320 through 486.360; or
    (ii) Has outcome requirements as described in Sec. 486.318(e)(6) at 
the final assessment period of the agreement cycle.
    (b) De-certification and competition. If an OPO fails to meet the 
outcome measures set forth in Sec. 486.318(e)(6) at the final 
assessment period prior to the end of the agreement cycle, or it meets 
the requirements described in paragraph (a)(3) of this section:
    (1) CMS will send the OPO a notice of its initial de-certification 
determination and the OPO has the right to appeal as established in 
Sec. 486.314;
    (2) If the OPO does not appeal or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area is opened for competition from 
other OPOs that qualify to compete for open service areas as set forth 
in paragraph (c) of this section. The de-certified OPO is not permitted 
to compete for its open area or any other open area.
    (3) The OPO competing for the open service area must submit 
information and data that describe the barriers in its service area, how 
they affected organ donation, what steps the OPO took to overcome them, 
and the results.
    (c) Criteria to compete. To compete for an open DSA, an OPO must 
meet the performance requirements of the outcome measures for Tier 1 or 
Tier 2 at Sec. 486.318(e)(4) and (5), and the requirements for 
certification at Sec. 486.303, including the conditions for coverage at 
Sec. Sec. 486.320 through 486.360 at the most recent routine survey. 
The OPO must compete for the entire DSA.
    (d) Criteria for selection. CMS will designate an OPO for an open 
service area based on the following criteria:

[[Page 259]]

    (1) Performance on the outcome measures at Sec. 486.318;
    (2) Relative success in meeting the process performance measures and 
other conditions at Sec. Sec. 486.320 through 486.348;
    (3) Contiguity to the open service area.
    (4) Success in identifying and overcoming barriers to donation 
within its own service area and the relevance of those barriers to 
barriers in the open area. An OPO competing for an open service area 
must submit information and data that describe the barriers in its 
service area, how they affected organ donation, what steps the OPO took 
to overcome them, and the results.
    (e) No OPO applies. If no OPO applies to compete for a de-certified 
OPO's open area, CMS may select a single OPO to take over the entire 
open area or may adjust the service area boundaries of two or more 
contiguous OPOs to incorporate the open area. CMS will make its decision 
based on the criteria in paragraph (d) of this section.
    (f) Extension of the agreement cycle for extraordinary 
circumstances. OPOs can seek a 1-year extension of the agreement cycle 
if there are extraordinary circumstances beyond the control of the OPOs 
that has affected the data of the final assessment period so that it 
does not accurately capture their performance. OPOs must request this 
extension within 90 days of the end of the occurrence of the 
extraordinary circumstance but no later than the last day of the final 
assessment period.
    (g) Exception. For the 2022 recertification cycle only, an OPO is 
recertified for an additional 4 years and its service area is not opened 
for competition when the OPO meets one out of the two outcome measure 
requirements described in Sec. 486.318(a)(1) and (3) for OPOs not 
operating exclusively in the noncontiguous States, Commonwealths, 
Territories, or possessions; or Sec. 486.318(b)(1) and (3) for OPOs 
operating exclusively in noncontiguous States, Commonwealths, 
Territories, and possessions. An OPO is not required to meet the second 
outcome measure described in Sec. 486.318(a)(2) or (b)(2) for the 2022 
recertification cycle. If an OPO does not meet one of the outcome 
measures as described in paragraphs Sec. 486.318(a)(1), (a)(3), (b)(1), 
or (b)(3), or has been shown by survey to not be in compliance with the 
requirements for certification at Sec. 486.303, including the 
conditions for coverage at Sec. Sec. 486.320 through 486.360, the OPO 
is de-certified. If the OPO does not appeal or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area is opened for competition from 
other OPOs. The de-certified OPO is not permitted to compete for its 
open area or any other open area. An OPO competing for an open service 
area must submit information and data that describe the barriers in its 
service area, how they affected organ donation, what steps the OPO took 
to overcome them, and the results.

[71 FR 31046, May 31, 2006, as amended at 78 FR 75199, Dec. 10, 2013; 84 
FR 61492, Nov. 12, 2019; 85 FR 77947, Dec. 2, 2020]

           Organ Procurement Organization Outcome Requirements



Sec. 486.318  Condition: Outcome measures.

    (a) With the exception of OPOs operating exclusively in 
noncontiguous States, Commonwealths, Territories, or possessions, an OPO 
must meet two out of the three following outcome measures:
    (1) The OPO's donation rate of eligible donors as a percentage of 
eligible deaths is no more than 1.5 standard deviations below the mean 
national donation rate of eligible donors as a percentage of eligible 
deaths, averaged over the 4 years of the re-certification cycle. Both 
the numerator and denominator of an individual OPO's donation rate ratio 
are adjusted by adding a 1 for each donation after cardiac death donor 
and each donor over the age of 70;
    (2) The observed donation rate is not significantly lower than the 
expected donation rate for 18 or more months of the 36 months of data 
used for re-certification, as calculated by the SRTR;
    (3) The OPO data reports, averaged over the 4 years of the 
recertification cycle, must meet the rules and requirements of the most 
current OPTN aggregate donor yield measure.

[[Page 260]]

    (i) The initial criteria used to identify OPOs with lower than 
expected organ yield, for all organs as well as for each organ type, 
will include all of the following:
    (A) More than 10 fewer observed organs per 100 donors than expected 
yield (Observed per 100 donors--Expected per 100 donors <-10);
    (B) A ratio of observed to expected yield less than 0.90; and
    (C) A two-sided p-value is less than 0.05.
    (ii) The number of organs used for research per donor, including 
pancreata used for islet cell research.
    (4) The outcome measures described in Sec. 486.318(a)(1) through 
(3) are effective until July 31, 2022.
    (b) For OPOs operating exclusively in noncontiguous States, 
Commonwealths, Territories, and possessions, an OPO must meet two out of 
the three following outcome measures:
    (1) The OPO's donation rate of eligible donors as a percentage of 
eligible deaths is no more than 1.5 standard deviations below the mean 
national donation rate of eligible donors as a percentage of eligible 
deaths, averaged over the 4 years of the re-certification cycle. Both 
the numerator and denominator of an individual OPO's donation rate ratio 
are adjusted by adding a 1 for each donation after cardiac death donor 
and each donor over the age of 70;
    (2) The observed donation rate is not significantly lower than the 
expected donation rate for 18 or more months of the 36 months of data 
used for re-certification, as calculated by the SRTR;
    (3) The OPO data reports, averaged over the 4 years of the 
recertification cycle, must meet the rules and requirements of the most 
current OPTN aggregate donor yield measure.
    (i) The initial criteria used to identify OPOs with lower than 
expected organ yield, for all organs as well as for each organ type, 
will include all of the following:
    (A) More than 10 fewer observed organs per 100 donors than expected 
yield (Observed per 100 donors--Expected per 100 donors <-10);
    (B) A ratio of observed to expected yield less than 0.90; and
    (C) A two-sided p-value is less than 0.05.
    (ii) The number of organs used for research per donor, including 
pancreata used for islet cell research.
    (4) The outcome measures described in Sec. 486.318(b)(1) through 
(3) are effective until July 31, 2022.
    (c) Data for the outcome measures.
    (1) An OPO's performance on the outcome measures is based on 36 
months of data, beginning with January 1 of the first full year of the 
re-certification cycle and ending 36 months later on December 31, 7 
months prior to the end of the re-certification cycle.
    (2) If an OPO takes over another OPO's service area on a date later 
than January 1 of the first full year of the re-certification cycle so 
that 36 months of data are not available to evaluate the OPO's 
performance in its new service area, we will not hold the OPO 
accountable for its performance in the new area until the end of the 
following re-certification cycle when 36 months of data are available.
    (3) An OPO's performance on the outcome measures described in Sec. 
486.318(a)(1) through (3) and Sec. 486.318(b)(1) through (3) is based 
on the data described in Sec. 486.318(c)(1) and (2) until July 31, 
2022.
    (d) An OPO is evaluated by measuring the donation rate and the organ 
transplantation rate in their DSA.
    (1) For all OPOs, except as set forth in paragraph (d)(2) of this 
section, for all OPOs:
    (i) The donation rate is calculated as the number of donors in the 
DSA as a percentage of the donor potential.
    (ii) The organ transplantation rate is calculated as the number of 
organs transplanted from donors in the DSA as a percentage of the donor 
potential. The organ transplantation rate is adjusted for the average 
age of the donor potential.
    (iii) The numerator for the donation rate is the number of donors in 
the DSA. The numerator for the organ transplantation rate is the number 
of organs transplanted from donors in the DSA. The numbers of donors and 
organs transplanted are based on the data submitted to the OPTN as 
required in Sec. 486.328 and Sec. 121.11 of this title. For 
calculating each measure,

[[Page 261]]

the data used is from the same time period as the data for the donor 
potential.
    (iv) The denominator for the outcome measures is the donor potential 
and is based on inpatient deaths within the DSA from patients 75 or 
younger with a primary cause of death that is consistent with organ 
donation. The data is obtained from the most recent 12-months data from 
state death certificates.
    (2) For the OPO representing the Hawaii DSA:
    (i) The donation rate is calculated as the number of donors in the 
DSA as a percentage of the donor potential.
    (ii) The kidney transplantation rate is calculated as the number of 
kidneys transplanted from kidney donors in the DSA as a percentage of 
the donor potential.
    (iii) The numerator for the donation rate is the number of donors in 
the DSA. The numerator for the kidney transplantation rate is the number 
of kidneys transplanted from kidney donors in the DSA. The numbers of 
donors and kidneys transplanted are based on the data submitted to the 
OPTN as required in Sec. 486.328 and Sec. 121.11 of this title. For 
calculating each measure, the data used is from the same time period as 
the data for the donor potential.
    (iv) The denominator for the outcome measures is the donor potential 
and is based on inpatient deaths within the DSA from patients 75 or 
younger with a primary cause of death that is consistent with organ 
donation. The data is obtained from the most recent 12-months data from 
state death certificates.
    (e) An OPO must demonstrate a success rate on the outcome measures 
in accordance with the following parameters and requirements:
    (1) For each assessment period, threshold rates will be established 
based on donation rates during the 12-month period immediately prior to 
the period being evaluated:
    (i) The lowest rate among the top 25 percent in DSAs, and
    (ii) The median rate among the DSAs.
    (2) For each assessment period, threshold rates will be established 
based on the organ transplantation or kidney transplantation rates 
during the 12-month period prior to the period being evaluated:
    (i) The lowest rate among the top 25 percent, and
    (ii) The median rate among the DSAs.
    (3) The 95 percent confidence interval for each DSA's donation and 
organ transplantation rates will be calculated using a one-sided test.
    (4) Tier 1--OPOs that have an upper limit of the one-sided 95 
percent confidence interval for their donation and organ transplantation 
rates that are at or above the top 25 percent threshold rate established 
for their DSA will be identified at each assessment period.
    (5) Tier 2--OPOs that have an upper limit of the one-sided 95 
percent confidence interval for their donation and organ transplantation 
rates that are at or above the median threshold rate established for 
their DSA but is not in Tier 1 as described in paragraph (e)(4) of this 
section will be identified at each assessment period.
    (6) Tier 3--OPOs that have an upper limit of the one-sided 95 
percent confidence interval for their donation or organ transplantation 
rates that are below the median threshold rate established for their DSA 
will be identified at each assessment period. OPOs that have an upper 
limit of the one-sided 95 percent confidence interval for their donation 
and organ transplantation rates that are below the median threshold rate 
for their DSA are also included in Tier 3.
    (7) For the OPO exclusively serving the DSA that includes the non-
contiguous state of Hawaii and surrounding territories, the kidney 
transplantation rate will be used instead of the organ transplantation 
rate. The comparative performance and designation to a Tier will be the 
same as in paragraphs (e)(4), (5), and (6) of this section except kidney 
transplantation rates will be used.
    (f)(1) An OPO's performance on the outcome measures is based on an 
evaluation at least every 12 months, with the most recent 12 months of 
data available from the OPTN and state death certificates, beginning 
January 1 of the first year of the agreement cycle

[[Page 262]]

and ending December 31, prior to the end of the agreement cycle.
    (2) An assessment period is the most recent 12 months prior to the 
evaluation of the outcome measures in which data is available.
    (3) If an OPO takes over another OPO's DSA on a date later than 
January 1 of the first year of the agreement cycle so that 12 months of 
data are not available to evaluate the OPO's performance in its new DSA, 
we will hold the OPO accountable for its performance on the outcome 
measures in the new area once 12 months of data are available.

[71 FR 31046, May 31, 2006, as amended at 78 FR 75199, Dec. 10, 2013; 81 
FR 79881, Nov. 14, 2016; 85 FR 77948, Dec. 2, 2020]

       Organ Procurement Organization Process Performance Measures



Sec. 486.320  Condition: Participation in Organ Procurement
and Transplantation Network.

    After being designated, an OPO must become a member of, participate 
in, and abide by the rules and requirements of the OPTN established and 
operated in accordance with section 372 of the Public Health Service Act 
(42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means 
those rules and requirements approved by the Secretary. No OPO is 
considered out of compliance with section 1138(b)(1)(D) of the Act or 
this section until the Secretary approves a determination that the OPO 
failed to comply with the rules and requirements of the OPTN. The 
Secretary may impose sanctions under section 1138 only after such non-
compliance has been determined in this manner.



Sec. 486.322  Condition: Relationships with hospitals, critical access
hospitals, and tissue banks.

    (a) Standard: Hospital agreements. An OPO must have a written 
agreement with 95 percent of the Medicare and Medicaid participating 
hospitals and critical access hospitals in its service area that have 
both a ventilator and an operating room and have not been granted a 
waiver by CMS to work with another OPO. The agreement must describe the 
responsibilities of both the OPO and hospital or critical access 
hospital in regard to donation after cardiac death (if the OPO has a 
protocol for donation after cardiac death) and the requirements for 
hospitals at Sec. 482.45 or Sec. 485.643. The agreement must specify 
the meaning of the terms ``timely referral'' and ``imminent death.''
    (b) Standard: Designated requestor training for hospital staff. The 
OPO must offer to provide designated requestor training on at least an 
annual basis for hospital and critical access hospital staff.
    (c) Standard: Cooperation with tissue banks.
    (1) The OPO must have arrangements to cooperate with tissue banks 
that have agreements with hospitals and critical access hospitals with 
which the OPO has agreements. The OPO must cooperate in the following 
activities, as may be appropriate, to ensure that all usable tissues are 
obtained from potential donors:
    (i) Screening and referral of potential tissue donors.
    (ii) Obtaining informed consent from families of potential tissue 
donors.
    (iii) Retrieval, processing, preservation, storage, and distribution 
of tissues.
    (iv) Providing designated requestor training.
    (2) An OPO is not required to have an arrangement with a tissue bank 
that is unwilling to have an arrangement with the OPO.



Sec. 486.324  Condition: Administration and governing body.

    (a) While an OPO may have more than one board, the OPO must have an 
advisory board that has both the authority described in paragraph (b) of 
this section and the following membership:
    (1) Members who represent hospital administrators, either intensive 
care or emergency room personnel, tissue banks, and voluntary health 
associations in the OPO's service area.
    (2) Individuals who represent the public residing in the OPO's 
service area.
    (3) A physician with knowledge, experience, or skill in the field of 
human histocompatibility, or an individual with a doctorate degree in a 
biological

[[Page 263]]

science and with knowledge, experience, or skills in the field of human 
histocompatibility.
    (4) A neurosurgeon or other physician with knowledge or skills in 
the neurosciences.
    (5) A transplant surgeon representing each transplant hospital in 
the service area with which the OPO has arrangements to coordinate its 
activities. The transplant surgeon must have practicing privileges and 
perform transplants in the transplant hospital represented.
    (6) An organ donor family member.
    (b) The OPO board described in paragraph (a) of this section has the 
authority to recommend policies for the following:
    (1) Procurement of organs.
    (2) Effective agreements to identify potential organ donors with a 
substantial majority of hospitals in its service area that have 
facilities for organ donation.
    (3) Systematic efforts, including professional education, to acquire 
all useable organs from potential donors.
    (4) Arrangements for the acquisition and preservation of donated 
organs and provision of quality standards for the acquisition of organs 
that are consistent with the standards adopted by the OPTN, including 
arranging for testing with respect to preventing the acquisition of 
organs that are infected with the etiologic agent for acquired 
immunodeficiency syndrome (AIDS).
    (5) Appropriate tissue typing of organs.
    (6) A system for allocation of organs among transplant patients that 
is consistent with the rules and requirements of the OPTN, as defined in 
Sec. 486.320 of this part.
    (7) Transportation of organs to transplant hospitals.
    (8) Coordination of activities with transplant hospitals in the 
OPO's service area.
    (9) Participation in the OPTN.
    (10) Arrangements to cooperate with tissue banks for the retrieval, 
processing, preservation, storage, and distribution of tissues as may be 
appropriate to assure that all useable tissues are obtained from 
potential donors.
    (11) Annual evaluation of the effectiveness of the OPO in acquiring 
organs.
    (12) Assistance to hospitals in establishing and implementing 
protocols for making routine inquiries about organ donations by 
potential donors.
    (c) The advisory board described in paragraph (a) of this section 
has no authority over any other activity of the OPO and may not serve as 
the OPO's governing body or board of directors. Members of the advisory 
board described in paragraph (a) of this section are prohibited from 
serving on any other OPO board.
    (d) The OPO must have bylaws for each of its board(s) that address 
potential conflicts of interest, length of terms, and criteria for 
selecting and removing members.
    (e) A governing body must have full legal authority and 
responsibility for the management and provision of all OPO services and 
must develop and oversee implementation of policies and procedures 
considered necessary for the effective administration of the OPO, 
including fiscal operations, the OPO's quality assessment and 
performance improvement (QAPI) program, and services furnished under 
contract or arrangement, including agreements for these services. The 
governing body must appoint an individual to be responsible for the day-
to-day operation of the OPO.
    (f) The OPO must have procedures to address potential conflicts of 
interest for the governing body described in paragraph (d) of this 
section.
    (g) The OPO's policies must state whether the OPO recovers organs 
from donors after cardiac death.

[71 FR 31046, May 31, 2006, as amended at 77 FR 29031, May 16, 2012]



Sec. 486.326  Condition: Human resources.

    All OPOs must have a sufficient number of qualified staff, including 
a director, a medical director, organ procurement coordinators, and 
hospital development staff to obtain all usable organs from potential 
donors, and to ensure that required services are provided to families of 
potential donors, hospitals, tissue banks, and individuals and 
facilities that use organs for research.

[[Page 264]]

    (a) Standard: Qualifications. (1) The OPO must ensure that all 
individuals who provide services and/or supervise services, including 
services furnished under contract or arrangement, are qualified to 
provide or supervise the services.
    (2) The OPO must develop and implement a written policy that 
addresses potential conflicts of interest for the OPO's director, 
medical director, senior management, and procurement coordinators.
    (3) The OPO must have credentialing records for physicians and other 
practitioners who routinely recover organs in hospitals under contract 
or arrangement with the OPO and ensure that all physicians and other 
practitioners who recover organs in hospitals with which the OPO has 
agreements are qualified and trained.
    (b) Standard: Staffing. (1) The OPO must provide sufficient 
coverage, either by its own staff or under contract or arrangement, to 
assure both that hospital referral calls are screened for donor 
potential and that potential donors are evaluated for medical 
suitability for organ and/or tissue donation in a timely manner.
    (2) The OPO must have a sufficient number of qualified staff to 
provide information and support to potential organ donor families; 
request consent for donation; ensure optimal maintenance of the donor, 
efficient placement of organs, and adequate oversight of organ recovery; 
and conduct QAPI activities, such as death record reviews and hospital 
development.
    (3) The OPO must provide a sufficient number of recovery personnel, 
either from its own staff or under contract or arrangement, to ensure 
that all usable organs are recovered in a manner that, to the extent 
possible, preserves them for transplantation.
    (c) Standard: Education, training, and performance evaluation. The 
OPO must provide its staff with the education, training, and supervision 
necessary to furnish required services. Training must include but is not 
limited to performance expectations for staff, applicable organizational 
policies and procedures, and QAPI activities. OPOs must evaluate the 
performance of their staffs and provide training, as needed, to improve 
individual and overall staff performance and effectiveness.
    (d) Standard: Medical director. The OPO's medical director is a 
physician licensed in at least one of the States or territories within 
the OPO's service area or as required by State or territory law or by 
the jurisdiction in which the OPO is located. The medical director is 
responsible for implementation of the OPO's protocols for donor 
evaluation and management and organ recovery and placement. The medical 
director is responsible for oversight of the clinical management of 
potential donors, including providing assistance in managing a donor 
case when the surgeon on call is unavailable.



Sec. 486.328  Condition: Reporting of data.

    (a) An OPO must provide individually-identifiable, hospital-specific 
organ donation and transplantation data and other information to the 
Organ Procurement and Transplantation Network, the Scientific Registry 
of Transplant Recipients, and HHS, as requested by the Secretary. The 
data may include, but are not limited to:
    (1) Number of hospital deaths;
    (2) Results of death record reviews;
    (3) Number and timeliness of referral calls from hospitals;
    (4) [Reserved]
    (5) Data related to non-recovery of organs;
    (6) Data about consents for donation;
    (7) Number of donors;
    (8) Number of organs recovered, by type of organ; and
    (9) Number of organs transplanted, by type of organ.
    (b) An OPO must provide hospital-specific organ donation data 
annually to the transplant hospitals with which it has agreements.
    (c) Data to be used for OPO re-certification purposes must be 
reported to the OPTN and must include data for all deaths in all 
hospitals and critical access hospitals in the OPO's donation service 
area, unless a hospital or critical access hospital has been granted a 
waiver to work with a different OPO.
    (d) Data reported by the OPO to the OPTN must be reported within 30 
days after the end of the month in which a death occurred. If an OPO 
determines through death record review or other

[[Page 265]]

means that the data it reported to the OPTN was incorrect, it must 
report the corrected data to the OPTN within 30 days of the end of the 
month in which the error is identified.
    (e) For the purpose of determining the information to be collected 
under paragraph (a) of this section, the following definitions apply:
    (1) Kidneys procured. Each kidney recovered will be counted 
individually. En bloc kidneys recovered will count as two kidneys 
procured.
    (2) Kidneys transplanted. Each kidney transplanted will be counted 
individually. En bloc kidney transplants will be counted as two kidneys 
transplanted.
    (3) Extra-renal organs procured. Each organ recovered is counted 
individually.
    (4) Extra-renal organs transplanted. Each organ or part thereof 
transplanted will be counted individually. For example, a single liver 
is counted as one organ procured and each portion that is transplanted 
will count as one transplant. Further, a heart and double lung 
transplant will be counted as three organs transplanted. A kidney/
pancreas transplant will count as one kidney transplanted and one extra-
renal organ transplanted.

[71 FR 31046, May 31, 2006, as amended at 85 FR 77949, Dec. 2, 2020]



Sec. 486.330  Condition: Information management.

    An OPO must establish and use an electronic information management 
system to maintain the required medical, social and identifying 
information for every donor and transplant beneficiary and develop and 
follow procedures to ensure the confidentiality and security of the 
information.
    (a) Donor information. The OPO must maintain a record for every 
donor. The record must include, at a minimum, information identifying 
the donor (for example, name, address, date of birth, social security 
number or other unique identifier, such as Medicare health insurance 
claim number), organs and (when applicable) tissues recovered, date of 
the organ recovery, donor management data, all test results, current 
hospital history, past medical and social history, the pronouncement of 
death, and consent and next-of-kin information.
    (b) Disposition of organs. The OPO must maintain records showing the 
disposition of each organ recovered for the purpose of transplantation, 
including information identifying transplant beneficiaries.
    (c) Data retention. Donor and transplant beneficiary records must be 
maintained in a human readable and reproducible paper or electronic 
format for 7 years.
    (d) Format of records. The OPO must maintain data in a format that 
can readily be transferred to a successor OPO and in the event of a 
transfer must provide to CMS copies of all records, data, and software 
necessary to ensure uninterrupted service by a successor OPO. Records 
and data subject to this requirement include donor and transplant 
beneficiary records and procedural manuals and other materials used in 
conducting OPO operations.



Sec. 486.342  Condition: Requesting consent.

    An OPO must encourage discretion and sensitivity with respect to the 
circumstances, views, and beliefs of potential donor families.
    (a) An OPO must have a written protocol to ensure that, in the 
absence of a donor document, the individual(s) responsible for making 
the donation decision are informed of their options to donate organs or 
tissues (when the OPO is making a request for tissues) or to decline to 
donate. The OPO must provide to the individual(s) responsible for making 
the donation decision, at a minimum, the following:
    (1) A list of the organs and/or tissues that may be recovered.
    (2) The most likely uses for the donated organs or tissues.
    (3) A description of the screening and recovery processes.
    (4) Information about the organizations that will recover, process, 
and distribute the tissue.
    (5) Information regarding access to and release of the donor's 
medical records.

[[Page 266]]

    (6) An explanation of the impact the donation process will have on 
burial arrangements and the appearance of the donor's body.
    (7) Contact information for individual(s) with questions or 
concerns.
    (8) A copy of the signed consent form if a donation is made.
    (b) If an OPO does not request consent to donation because a 
potential donor consented to donation before his or her death in a 
manner that satisfied applicable State law requirements in the potential 
donor's State of residence, the OPO must provide information about the 
donation to the family of the potential donor, as requested.



Sec. 486.344  Condition: Evaluation and management of potential donors
and organ placement and recovery.

    The OPO must have written protocols for donor evaluation and 
management and organ placement and recovery that meet current standards 
of practice and are designed to maximize organ quality and optimize the 
number of donors and the number of organs recovered and transplanted per 
donor.
    (a) Potential donor protocol management. (1) The medical director is 
responsible for ensuring that potential donor evaluation and management 
protocols are implemented correctly and appropriately to ensure that 
potential donors are thoroughly assessed for medical suitability for 
organ donation and clinically managed to optimize organ viability and 
function.
    (2) The OPO must implement a system that ensures that a qualified 
physician or other qualified individual is available to assist in the 
medical management of a potential donor when the surgeon on call is 
unavailable.
    (b) Potential donor evaluation. The OPO must do the following:
    (1) Verify that death has been pronounced according to applicable 
local, State, and Federal laws.
    (2) Determine whether there are conditions that may influence donor 
acceptance.
    (3) If possible, obtain the potential donor's medical and social 
history.
    (4) Review the potential donor's medical chart and perform a 
physical examination of the donor.
    (5) Obtain the potential donor's vital signs and perform all 
pertinent tests.
    (c) Testing. The OPO must do the following:
    (1) Arrange for screening and testing of the potential donor for 
infectious disease according to current standards of practice, including 
testing for the human immunodeficiency virus.
    (2) Ensure that screening and testing of the potential donor 
(including point-of-care testing and blood typing) are conducted by a 
laboratory that is certified in the appropriate specialty or 
subspecialty of service in accordance with part 493 of this chapter.
    (3) Ensure that the potential donor's blood is typed using two 
separate blood samples.
    (4) Document potential donor's record with all test results, 
including blood type, before organ recovery.
    (d) Standard: Collaboration with transplant programs. (1) The OPO 
must establish protocols in collaboration with transplant programs that 
define the roles and responsibilities of the OPO and the transplant 
program for all activities associated with the evaluation and management 
of potential donors, organ recovery, and organ placement, including 
donation after cardiac death, if the OPO has implemented a protocol for 
donation after cardiac death.
    (2) The protocol must ensure that:
    (i) The OPO is responsible for two separate determinations of the 
donor's blood type;
    (ii) If the identity of the intended recipient is known, the OPO has 
a procedure to ensure that prior to organ recovery, an individual from 
the OPO's staff compares the blood type of the donor with the blood type 
of the intended recipient, and the accuracy of the comparison is 
verified by a different individual;
    (iii) Documentation of the donor's blood type accompanies the organ 
to the hospital where the transplant will take place.
    (3) The established protocols must be reviewed regularly with the 
transplant programs to incorporate practices that have been shown to 
maximize organ donation and transplantation.
    (e) Documentation of beneficiary information. If the intended 
beneficiary has been identified prior to recovery of an

[[Page 267]]

organ for transplantation, the OPO must have written documentation from 
the OPTN showing, at a minimum, the intended organ beneficiary's ranking 
in relation to other suitable candidates and the recipient's OPTN 
identification number and blood type.
    (f) Donation after cardiac death. If an OPO recovers organs from 
donors after cardiac death, the OPO must have protocols that address the 
following:
    (1) Criteria for evaluating patients for donation after cardiac 
death;
    (2) Withdrawal of support, including the relationship between the 
time of consent to donation and the withdrawal of support;
    (3) Use of medications and interventions not related to withdrawal 
of support;
    (4) Involvement of family members prior to organ recovery;
    (5) Criteria for declaration of death and the time period that must 
elapse prior to organ recovery.
    (g) Organ allocation. The OPO must have a system to allocate donated 
organs among transplant patients that is consistent with the rules and 
requirements of the OPTN, as defined in Sec. 486.320 of this part.
    (h) Organ placement. The OPO must develop and implement a protocol 
to maximize placement of organs for transplantation.

[71 FR 31046, May 31, 2006, as amended at 79 FR 27156, May 12, 2014]



Sec. 486.346  Condition: Organ preparation and transport.

    (a) The OPO must arrange for testing of organs for infectious 
disease and tissue typing of organs according to current standards of 
practice. The OPO must ensure that testing and tissue typing of organs 
are conducted by a laboratory that is certified in the appropriate 
specialty or subspecialty of service in accordance with part 493 of this 
chapter.
    (b)(1) The OPO must send complete documentation of donor information 
to the transplant center with the organ, including donor evaluation, the 
complete record of the donor's management, documentation of consent, 
documentation of the pronouncement of death, and documentation for 
determining organ quality. This information is available to the 
transplant center electronically.
    (2) The OPO must physically send a paper copy of the following 
documentation with each organ:
    (i) Blood type;
    (ii) Blood subtype, if used for allocation; and
    (iii) Infectious disease testing results available at the time of 
organ packaging.
    (3) The source documentation must be placed in a watertight 
container in either of the following:
    (i) A location specifically designed for documentation; or
    (ii) Between the inner and external transport materials.
    (4) Two individuals, one of whom must be an OPO employee, must 
verify that the documentation that accompanies an organ to a transplant 
center is correct.
    (c) The OPO must develop and follow a written protocol for 
packaging, labeling, handling, and shipping organs in a manner that 
ensures their arrival without compromise to the quality of the organ. 
The protocol must include procedures to check the accuracy and integrity 
of labels, packaging, and contents prior to transport, including 
verification by two individuals, one of whom must be an OPO employee, 
that information listed on the labels is correct.
    (d) All packaging in which an organ is transported must be marked 
with the identification number, specific contents, and donor's blood 
type.

[71 FR 31046, May 31, 2006, as amended at 81 FR 79881, Nov. 14, 2016]



Sec. 486.348  Condition: Quality assessment and performance improvement
(QAPI).

    The OPO must develop, implement, and maintain a comprehensive, data-
driven QAPI program designed to monitor and evaluate performance of all 
donation services, including services provided under contract or 
arrangement.
    (a) Standard: Components of a QAPI program. The OPO's QAPI program 
must include objective measures to evaluate and demonstrate improved

[[Page 268]]

performance with regard to OPO activities, such as hospital development, 
designated requestor training, donor management, timeliness of on-site 
response to hospital referrals, consent practices, organ recovery and 
placement, and organ packaging and transport. The OPO must take actions 
that result in performance improvements and track performance to ensure 
that improvements are sustained.
    (b) Standard: Death record reviews. As part of its ongoing QAPI 
efforts, an OPO must conduct at least monthly death record reviews in 
every Medicare and Medicaid participating hospital in its service area 
that has a Level I or Level II trauma center or 150 or more beds, a 
ventilator, and an intensive care unit (unless the hospital has a waiver 
to work with another OPO), with the exception of psychiatric and 
rehabilitation hospitals. When missed opportunities for donation are 
identified, the OPO must implement actions to improve performance.
    (c) Standard: Adverse events. (1) An OPO must establish written 
policies to address, at a minimum, the process for identification, 
reporting, analysis, and prevention of adverse events that occur during 
the organ donation process.
    (2) The OPO must conduct a thorough analysis of any adverse event 
and must use the analysis to affect changes in the OPO's policies and 
practices to prevent repeat incidents.
    (d) Standard: Review of outcome measures. (1) An OPO must include a 
process to review its performance on the outcome measure requirements at 
Sec. 486.318. The process must be a continuous activity to improve 
performance.
    (2) An OPO must incorporate data on the outcome measures into their 
QAPI program.
    (3) If the outcome measure at each assessment period during the re-
certification cycle is statistically significantly lower than the top 25 
percent of donation rates or organ or kidney transplantation (Tier 2 and 
Tier 3 OPOs) rates as described in Sec. 486.318(e)(5) and (6), the OPO 
must identify opportunities for improvement and implement changes that 
lead to improvement in these measures.

[71 FR 31046, May 31, 2006, as amended at 85 FR 77949, Dec. 2, 2020]



Sec. 486.360  Condition for Coverage: Emergency preparedness.

    The Organ Procurement Organization (OPO) must comply with all 
applicable Federal, State, and local emergency preparedness 
requirements. The OPO 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 OPO must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address the type of hospitals with which the OPO has agreements; 
the type of services the OPO has the capacity 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 OPO 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) A system to track the location of on-duty staff during and after 
an emergency. If on-duty staff is relocated during the emergency, the 
OPO must document the specific name and location of the receiving 
facility or other location.

[[Page 269]]

    (2) A system of medical documentation that preserves potential and 
actual donor information, protects confidentiality of potential and 
actual donor information, and secures and maintains the availability of 
records.
    (c) Communication plan. The OPO 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) Volunteers.
    (iv) Other OPOs.
    (v) Transplant and donor hospitals in the OPO's Donation Service 
Area (DSA).
    (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) OPO's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (d) Training and testing. The OPO 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. The OPO must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the OPO must conduct training on the updated 
policies and procedures.
    (2) Testing. The OPO must conduct exercises to test the emergency 
plan. The OPO must do the following:
    (i) Conduct a paper-based, tabletop exercise or workshop at least 
annually. A tabletop exercise 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. If the OPO 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the OPO is exempt from engaging in its 
next required testing exercise following the onset of the emergency 
event.
    (ii) Analyze the OPO's response to and maintain documentation of all 
tabletop exercises, and emergency events, and revise the OPO's emergency 
plan, as needed.
    (e) Continuity of OPO operations during an emergency. Each OPO must 
have a plan to continue operations during an emergency.
    (1) The OPO must develop and maintain in the protocols with 
transplant programs required under Sec. 486.344(d), mutually agreed 
upon protocols that address the duties and responsibilities of the 
transplant program, the hospital in which the transplant program is 
operated, and the OPO during an emergency.
    (2) The OPO must have the capability to continue its operation from 
an alternate location during an emergency. The OPO could either have:
    (i) An agreement with one or more other OPOs to provide essential 
organ procurement services to all or a portion of its DSA in the event 
the OPO cannot provide those services during an emergency;
    (ii) If the OPO has more than one location, an alternate location 
from

[[Page 270]]

which the OPO could conduct its operation; or
    (iii) A plan to relocate to another location as part of its 
emergency plan as required by paragraph (a) of this section.
    (f) Integrated healthcare systems. If an OPO 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 OPO may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of 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.
    (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 
all of 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 64040, Sept. 16, 2016, as amended at 84 FR 51830, Sept. 30, 2019]

Subpart H--[Reserved]



       Subpart I_Requirements for Home Infusion Therapy Suppliers

    Source: 83 FR 56630, Nov. 13, 2018, unless otherwise noted.

                           General Provisions



Sec. 486.500  Basis and scope.

    Section 1861(s)(2)(iii) of the Act requires the Secretary to 
establish the conditions that home infusion therapy suppliers must meet 
in order to participate in the Medicare program and which are considered 
necessary to ensure the health and safety of patients.



Sec. 486.505  Definitions.

    As used in Sec. Sec. 486.520 and 486.525:
    Applicable provider means a physician, a nurse practitioner, and a 
physician assistant.
    Home means a place of residence used as the home of an individual, 
including an institution that is used as a home. An institution that is 
used as a home may not be a hospital, CAH, or SNF as defined in section 
1861(e)(1), 1861(mm)(1), or 1819(a)(1) of the Act, respectively.
    Home infusion drug means a parental drug or biological administered 
intravenously, or subcutaneously for an administration period of 15 
minutes or more, in the home of an individual through a pump that is an 
item of durable medical equipment. The term does not include insulin 
pump systems or a self-administered drug or biological on a self-
administered drug exclusion list.
    Infusion drug administration calendar day means the day on which 
home infusion therapy services are furnished by skilled professionals in 
the individual's home on the day of infusion drug administration. The 
skilled services provided on such day must be so inherently complex that 
they can only be safely and effectively performed by, or under the 
supervision of, professional or technical personnel.
    Qualified home infusion therapy supplier means a supplier of home 
infusion therapy that meets the all of the following criteria which are 
set forth at section 1861(iii)(3)(D)(i) of the Act:

[[Page 271]]

    (1) Furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs.
    (2) Ensures the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
    (3) Is accredited by an organization designated by the Secretary in 
accordance with section 1834(u)(5) of the Act.
    (4) Meets such other requirements as the Secretary determines 
appropriate.

[83 FR 56630, Nov. 13, 2018, as amended at 84 FR 60646, Nov. 8, 2019]

                   Standards for Home Infusion Therapy



Sec. 486.520  Plan of care.

    The qualified home infusion therapy supplier ensures the following:
    (a) All patients must be under the care of an applicable provider.
    (b) All patients must have a plan of care established by a physician 
that prescribes the type, amount, and duration of the home infusion 
therapy services that are to be furnished.
    (c) The plan of care for each patient must be periodically reviewed 
by the physician.



Sec. 486.525  Required services.

    (a) The qualified home infusion therapy supplier must provide the 
following services on a 7-day-a-week, 24-hour-a-day basis in accordance 
with the plan of care:
    (1) Professional services, including nursing services.
    (2) Patient training and education not otherwise paid for as durable 
medical equipment as described in Sec. 424.57(c)(12) of this chapter.
    (3) Remote monitoring and monitoring services for the provision of 
home infusion therapy services and home infusion drugs.
    (b) All home infusion therapy suppliers must provide home infusion 
therapy services in accordance with nationally recognized standards of 
practice, and in accordance with all applicable state and federal laws 
and regulations.



PART 488_SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--
Table of Contents



                      Subpart A_General Provisions

Sec.
488.1 Definitions.
488.2 Statutory basis.
488.3 Conditions of participation, conditions for coverage, conditions 
          for certification and long term care requirements.
488.4 General rules for a CMS-approved accreditation program for 
          providers and suppliers.
488.5 Application and re-application procedures for national accrediting 
          organizations.
488.6 Providers or suppliers that participate in the Medicaid program 
          under a CMS-approved accreditation program.
488.7 Release and use of accreditation surveys.
488.8 Ongoing review of accrediting organizations.
488.9 Validation surveys.
488.10 State survey agency review: Statutory provisions.
488.11 State survey agency functions.
488.12 Effect of survey agency certification.
488.13 Loss of accreditation.
488.14 Effect of QIO review.
488.18 Documentation of findings.
488.20 Periodic review of compliance and approval.
488.24 Certification of noncompliance.
488.26 Determining compliance.
488.28 Providers or suppliers, other than SNFs, NFs, and HHAs with 
          deficiencies.
488.30 Revisit user fee for revisit surveys.

                     Subpart B_Special Requirements

488.52 [Reserved]
488.54 Temporary waivers applicable to hospitals.
488.56 Temporary waivers applicable to skilled nursing facilities.
488.60 Special procedures for approving end stage renal disease 
          facilities.
488.61 Special procedures for approval and re-approval of organ 
          transplant programs.
488.64 Remote facility variances for utilization review requirements.
488.68 State Agency responsibilities for OASIS collection and data base 
          requirements.

                  Subpart C_Survey Forms and Procedures

488.100 Long term care survey forms, Part A.
488.105 Long term care survey forms, Part B.
488.110 Procedural guidelines.

[[Page 272]]

488.115 Care guidelines.

 Subpart D_Reconsideration of Adverse Determinations_Deeming Authority 
for Accreditation Organizations and CLIA Exemption of Laboratories Under 
                             State Programs

488.201 Reconsideration.
488.203 Withdrawal of request for reconsideration.
488.205 Right to informal hearing.
488.207 Informal hearing procedures.
488.209 Hearing officer's findings.
488.211 Final reconsideration determination.

     Subpart E_Survey and Certification of Long-Term Care Facilities

488.300 Statutory basis.
488.301 Definitions.
488.303 State plan requirement.
488.305 Standard surveys.
488.307 Unannounced surveys.
488.308 Survey frequency.
488.310 Extended survey.
488.312 Consistency of survey results.
488.314 Survey teams.
488.318 Inadequate survey performance.
488.320 Sanctions for inadequate survey performance.
488.325 Disclosure of results of surveys and activities.
488.330 Certification of compliance or noncompliance.
488.331 Informal dispute resolution.
488.332 Investigation of complaints of violations and monitoring of 
          compliance.
488.334 Educational programs.
488.335 Action on complaints of resident neglect and abuse, and 
          misappropriation of resident property.

 Subpart F_Enforcement of Compliance For Long-Term Care Facilities with 
                              Deficiencies

488.400 Statutory basis.
488.401 Definitions.
488.402 General provisions.
488.404 Factors to be considered in selecting remedies.
488.406 Available remedies.
488.408 Selection of remedies.
488.410 Action when there is immediate jeopardy.
488.412 Action when there is no immediate jeopardy.
488.414 Action when there is repeated substandard quality of care.
488.415 Temporary management.
488.417 Denial of payment for all new admissions.
488.418 Secretarial authority to deny all payments.
488.422 State monitoring.
488.424 Directed plan of correction.
488.425 Directed inservice training.
488.426 Transfer of residents, or closure of the facility and transfer 
          of residents.
488.430 Civil money penalties: Basis for imposing penalty.
488.431 Civil money penalties imposed by CMS and independent informal 
          dispute resolution: for SNFS, dually-participating SNF/NFs, 
          and NF-only facilities.
488.432 Civil money penalties imposed by the State: NF-only.
488.433 Civil money penalties: Uses and approval of civil money 
          penalties imposed by CMS.
488.434 Civil money penalties: Notice of penalty.
488.436 Civil money penalties: Waiver of hearing, reduction of penalty 
          amount.
488.438 Civil money penalties: Amount of penalty.
488.440 Civil money penalties: Effective date and duration of penalty.
488.442 Civil money penalties: Due date for payment of penalty.
488.444 Civil money penalties: Settlement of penalties.
488.446 Administrator sanctions: long-term care facility closures.
488.447 Civil Money Penalties imposed for failure to comply with 42 CFR 
          483.80(g)(1) and (2).
488.450 Continuation of payments to a facility with deficiencies.
488.452 State and Federal disagreements involving findings not in 
          agreement in non-State operated NFs and dually participating 
          facilities when there is no immediate jeopardy.
488.454 Duration of remedies.
488.456 Termination of provider agreement.

Subpart G [Reserved]

Subpart H_Termination of Medicare Coverage and Alternative Sanctions for 
                End-Stage Renal Disease (ESRD) Facilities

488.604 Termination of Medicare coverage.
488.606 Alternative sanctions.
488.608 Notice of alternative sanction and appeal rights: Termination of 
          coverage.
488.610 Notice of appeal rights: Alternative sanctions.

       Subpart I_Survey and Certification of Home Health Agencies

488.700 Basis and scope.
488.705 Definitions.
488.710 Standard surveys.
488.715 Partial extended surveys.
488.720 Extended surveys.
488.725 Unannounced surveys.
488.730 Survey frequency and content.
488.735 Surveyor qualifications.

[[Page 273]]

488.740 Certification of compliance or noncompliance.
488.745 Informal Dispute Resolution (IDR).

     Subpart J_Alternative Sanctions for Home Health Agencies With 
                              Deficiencies

488.800 Statutory basis.
488.805 Definitions.
488.810 General provisions.
488.815 Factors to be considered in selecting sanctions.
488.820 Available sanctions.
488.825 Action when deficiencies pose immediate jeopardy.
488.830 Action when deficiencies are at the condition-level but do not 
          pose immediate jeopardy.
488.835 Temporary management.
488.840 Suspension of payment for all new patient admissions.
488.845 Civil money penalties.
488.850 Directed plan of correction.
488.855 Directed in-service training.
488.860 Continuation of payments to an HHA with deficiencies.
488.865 Termination of provider agreement.

Subpart K--[Reserved]

       Subpart L_Accreditation of Home Infusion Therapy Suppliers

                           General Provisions

488.1000 Basis and scope.
488.1005 Definitions.

  Approval and Oversight of Home Infusion Therapy Supplier Accrediting 
                              Organizations

488.1010 Application and reapplication procedures for national home 
          infusion therapy accrediting organizations.
488.1015 Resubmitting a request for reapproval.
488.1020 Public notice and comment.
488.1025 Release and use of home infusion therapy accreditation surveys.
488.1030 Ongoing review of home infusion therapy accrediting 
          organizations.
488.1035 Ongoing responsibilities of a CMS-approved home infusion 
          therapy accreditation organization.
488.1040 Onsite observations of home infusion therapy accrediting 
          organization operations.
488.1045 Voluntary and involuntary termination.
488.1050 Reconsideration.

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

    Source: 53 FR 22859, June 17, 1988, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 488.1  Definitions.

    As used in this part--
    Act means the Social Security Act.
    Certification means a determination made by the state survey agency 
that providers and suppliers are in compliance with the applicable 
conditions of participation, conditions for coverage, conditions for 
certification, or requirements.
    Conditions for certification means the health and safety standards 
RHCs must meet to participate in the Medicare program.
    Conditions for coverage means the requirements suppliers must meet 
to participate in the Medicare program.
    Conditions of participation means the requirements providers other 
than skilled nursing facilities must meet to participate in the Medicare 
program and includes conditions of certification for rural health 
clinics.
    Deemed status means that CMS has certified a provider or supplier 
for Medicare participation, based on all of the following criteria 
having been met: The provider or supplier has voluntarily applied for, 
and received, accreditation from a CMS-approved national accrediting 
organization under the applicable Medicare accreditation program; the 
accrediting organization has recommended the provider or supplier to CMS 
for Medicare participation; CMS has accepted the accrediting 
organization's recommendation; and CMS finds that all other 
participation requirements have been met.
    Full review means a survey of a provider or supplier for compliance 
with all of the Medicare conditions or requirements applicable to that 
provider or supplier type.
    Immediate jeopardy means a situation in which the provider's or 
supplier's non-compliance with one or more Medicare requirements, 
conditions of participation, conditions for coverage or certification 
has caused, or is likely to cause, serious injury, harm, impairment, or 
death to a resident or patient.
    Medicare condition means any condition of participation or for 
coverage, including any long term care requirements.

[[Page 274]]

    National accrediting organization means an organization that 
accredits provider entities, as that term is defined in section 
1865(a)(4) of the Act, under a specific program and whose accredited 
provider entities under each program are widely located geographically 
across the United States.
    Provider of services or provider refers to a hospital, critical 
access hospital, skilled nursing facility, nursing facility, home health 
agency, hospice, comprehensive outpatient rehabilitation facility, or a 
clinic, rehabilitation agency or public health agency that furnishes 
outpatient physical therapy or speech pathology services.
    Rate of disparity means the percentage of all sample validation 
surveys for which a State survey agency finds noncompliance with one or 
more Medicare conditions and no comparable condition level deficiency 
was cited by the accreditation organization, where it is reasonable to 
conclude that the deficiencies were present at the time of the 
accreditation organization's most recent surveys of providers or 
suppliers of the same type.

    Example: Assume that during a validation review period State survey 
agencies perform validation surveys at 200 facilities of the same type 
(for example, ambulatory surgical centers, home health agencies) 
accredited by the same accreditation organization. The State survey 
agencies find 60 of the facilities out of compliance with one or more 
Medicare conditions, and it is reasonable to conclude that these 
deficiencies were present at the time of the most recent survey by an 
accreditation organization. The accreditation organization, however, has 
found deficiencies comparable to the condition level deficiencies at 
only 22 of the 60 facilities. These validation results would yield ((60-
22)/200) a rate of disparity of 19 percent.

    Reasonable assurance means that an accrediting organization has 
demonstrated to CMS's satisfaction that its accreditation program 
requirements meet or exceed the Medicare program requirements.
    State includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, Guam, and American Samoa.
    State survey agency refers to the state health agency or other 
appropriate state or local agency CMS uses to perform survey and review 
functions provided for in sections 1864, 1819(g), and 1919(g) of the 
Act.
    Substantial allegation of non-compliance means a complaint from any 
of a variety of sources (such as patient, relative, or third party), 
including complaints submitted in person, by telephone, through written 
correspondence, or in newspaper or magazine articles, that would, if 
found to be present, adversely affect the health and safety of patients 
or residents and raises doubts as to a provider's or supplier's 
compliance with any Medicare condition of participation, condition for 
coverage, condition for certification, or requirements.
    Supplier means any of the following: Independent laboratory; 
portable X-ray services; physical therapist in independent practice; 
ESRD facility; rural health clinic; Federally qualified health center; 
chiropractor; or ambulatory surgical center.

[53 FR 22859, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989; 56 
FR 48879, Sept. 26, 1991; 57 FR 24982, June 12, 1992; 58 FR 30676, May 
26, 1993; 58 FR 61838, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997; 71 FR 
68230, Nov. 24, 2006; 80 FR 29834, May 22, 2015]



Sec. 488.2  Statutory basis.

    This part is based on the indicated provisions of the following 
sections of the Act:

1128--Exclusion of entities from participation in Medicare.
1128A--Civil money penalties.
1138(b)--Requirements for organ procurement organizations and organ 
procurement agencies.
1814--Conditions for, and limitations on, payment for Part A services.
1819--Requirements for SNFs.
1820--Requirements for CAHs.
1832(a)(2)(C)--Requirements for Organizations that provide outpatient 
physical therapy and speech language pathology services.
1832(a)(2)(F)--Requirements for ASCs.
1832(a)(2)(J)--Requirements for partial hospitalization services 
provided by CMHCs.
1861(e)--Requirements for hospitals.
1861(f)--Requirements for psychiatric hospitals.
1861(m)--Requirements for Home Health Services
1861(o)--Requirements for Home Health Agencies
1861(p)(4)--Requirements for rehabilitation agencies.

[[Page 275]]

1861(z)--Institutional planning standards that hospitals and SNFs must 
meet.
1861(aa)--Requirements for RHCs and FQHCs.
1861(cc)(2)--Requirements for CORFs.
1861(dd)--Requirements for hospices.
1861(ee)--Discharge planning guidelines for hospitals.
1861(ff)(3)(A)--Requirements for CMHCs.
1861(ss)(2)--Accreditation of religious nonmedical health care 
institutions.
1863--Consultation with state agencies, accrediting bodies, and other 
organizations to develop conditions of participation, conditions for 
coverage, conditions for certification, and requirements for providers 
or suppliers.
1864--Use of State survey agencies.
1865--Effect of accreditation.
1875(b)--Requirements for performance review of CMS-approved 
accreditation programs.
1880--Requirements for hospitals and SNFs of the Indian Health Service.
1881--Requirements for ESRD facilities.
1883--Requirements for hospitals that furnish extended care services.
1891--Conditions of participation for home health agencies; home health 
quality.
1902--Requirements for participation in the Medicaid program.
1913--Medicaid requirements for hospitals that provide NF care.
1919--Medicaid requirements for NFs.

[60 FR 50443, Sept. 29, 1995, as amended at 64 FR 67052, Nov. 30, 1999; 
77 FR 67164, Nov. 8, 2012; 80 FR 29834, May 22, 2015]



Sec. 488.3  Conditions of participation, conditions for coverage,
conditions for certification and long term care requirements.

    (a) Basic rules. To be approved for participation in, or coverage 
under, the Medicare program, a prospective provider or supplier must 
meet the following:
    (1) Meet the applicable statutory definitions in section 1138(b), 
1819, 1820, 1832(a)(2)(C), 1832(a)(2)(F), 1832(a)(2)(J), 1834(e), 1861, 
1881, 1883, 1891, 1913 or 1919 of the Act.
    (2) Be in compliance with the applicable conditions, certification 
requirements, or long term care requirements prescribed in part 405 
subparts U or X, part 410 subpart E, part 416, part 418 subpart C, parts 
482 through 486, part 491 subpart A, or part 494 of this chapter.
    (b) Special conditions. The Secretary shall consult with state 
agencies and national AOs, as applicable, to develop CoP, CfC, 
conditions for certification and long term care requirements.
    (1) The Secretary may, at a state's request, approve health and 
safety requirements for providers or suppliers in the state that exceed 
Medicare program requirements.
    (2) If a state or political subdivision imposes requirements on 
institutions (that exceed the Medicare program requirements) as a 
condition for the purchase of health services under a state Medicaid 
plan approved under title XIX of the Act, (or if Guam, Puerto Rico, or 
the Virgin Islands does so under a state plan for Old Age Assistance 
under title I of the Act, or for Aid to the Aged, Blind, and Disabled 
under the original title XVI of the Act), the Secretary imposes similar 
requirements as a condition for payment under Medicare in that state or 
political subdivision.

[80 FR 29835, May 22, 2015]



Sec. 488.4  General rules for a CMS-approved accreditation program 
for providers and suppliers.

    (a) The following requirements apply when a national accrediting 
organization has applied for CMS approval of a provider or supplier 
accreditation program and CMS has found that the program provides 
reasonable assurance for providers or suppliers accredited under the 
program:
    (1) When a provider or supplier demonstrates full compliance with 
all of the accreditation program requirements of the accrediting 
organization's CMS-approved accreditation program, the accrediting 
organization may recommend that CMS grant deemed status to the provider 
or supplier.
    (2) CMS may deem the provider or supplier, excluding kidney 
transplant centers within a hospital and ESRD facilities, to be in 
compliance with the applicable Medicare conditions or requirements. The 
deemed status provider or supplier is subject to validation surveys as 
provided at Sec. 488.9.
    (b) [Reserved]

[80 FR 29835, May 22, 2015]

[[Page 276]]



Sec. 488.5  Application and re-application procedures for national
accrediting organizations.

    (a) Information submitted with application. A national accrediting 
organization applying to CMS for approval or re-approval of an 
accreditation program under Sec. 488.4 must furnish CMS with all of the 
following information and materials to demonstrate that the program 
provides reasonable assurance that the entities accredited under the 
program meet or exceed the applicable Medicare conditions or 
requirements. This information must include the following:
    (1) Documentation that demonstrates the organization meets the 
definition of a ``national accrediting organization'' under Sec. 488.1 
as it relates to the accreditation program.
    (2) The type of provider or supplier accreditation program for which 
the organization is requesting approval or re-approval.
    (3) A detailed crosswalk (in table format) that identifies, for each 
of the applicable Medicare conditions or requirements, the exact 
language of the organization's comparable accreditation requirements and 
standards.
    (4) A detailed description of the organization's survey process to 
confirm that a provider or supplier meets or exceeds the Medicare 
program requirements. This description must include all of the following 
information:
    (i) Frequency of surveys performed and an agreement by the 
organization to re-survey every accredited provider or supplier, through 
unannounced surveys, no later than 36 months after the prior 
accreditation effective date, including an explanation of how the 
accrediting organization will maintain the schedule it proposes. If 
there is a statutorily-mandated survey interval of less than 36 months, 
the organization must indicate how it will adhere to the statutory 
schedule.
    (ii) Documentation demonstrating the comparability of the 
organization's survey process and surveyor guidance to those required 
for state survey agencies conducting federal Medicare surveys for the 
same provider or supplier type, in accordance with the applicable 
requirements or conditions of participation or conditions for coverage 
or certification.
    (iii) Copies of the organization's survey forms, guidelines, and 
instructions to surveyors.
    (iv) Documentation demonstrating that the organization's survey 
reports identify, for each finding of non-compliance with accreditation 
standards, the comparable Medicare CoP, CfC, conditions for 
certification, or requirements.
    (v) Description of the organization's accreditation survey review 
process.
    (vi) Description of the organization's procedures and timelines for 
notifying surveyed facilities of non-compliance with the accreditation 
program's standards.
    (vii) Description of the organization's procedures and timelines for 
monitoring the provider's or supplier's correction of identified non-
compliance with the accreditation program's standards.
    (viii) A statement acknowledging that, as a condition for CMS 
approval of a national accrediting organization's accreditation program, 
the organization agrees to provide CMS with information extracted from 
each accreditation survey for a specified provider or supplier as part 
of its data submissions required under paragraph (a)(11)(ii) of this 
section, a copy of all survey reports and related information for 
applicants seeking initial participation in Medicare, and, upon request 
from CMS, a copy of the most recent accreditation survey for a specified 
provider or supplier, together with any other information related to the 
survey as CMS may require (including corrective action plans).
    (ix) A statement acknowledging that the accrediting organization 
will provide timely notification to CMS when an accreditation survey or 
complaint investigation identifies an immediate jeopardy as that term is 
defined at Sec. 489.3 of this chapter. Using the format specified by 
CMS, the accrediting organization must notify CMS within two business 
days from the date the accrediting organization identifies the immediate 
jeopardy.

[[Page 277]]

    (5) The criteria for determining the size and composition of the 
organization's survey teams for the type of provider or supplier to be 
accredited, including variations in team size and composition for 
individual provider or supplier surveys.
    (6) The overall adequacy of the number of the organization's 
surveyors, including how the organization will increase the size of the 
survey staff to match growth in the number of accredited facilities 
while maintaining re-accreditation intervals for existing accredited 
facilities.
    (7) A description of the education and experience requirements 
surveyors must meet.
    (8) A description of the content and frequency of the organization's 
in-service training it provides to survey personnel.
    (9) A description of the organization's evaluation systems used to 
monitor the performance of individual surveyors and survey teams.
    (10) The organization's policies and procedures to avoid conflicts 
of interest, including the appearance of conflicts of interest, 
involving individuals who conduct surveys or participate in 
accreditation decisions.
    (11) A description of the organization's data management and 
analysis system for its surveys and accreditation decisions, including 
all of the following:
    (i) A detailed description of how the organization uses its data to 
assure the compliance of its accreditation program with the Medicare 
program requirements.
    (ii) A statement acknowledging that the organization agrees to 
submit timely, accurate, and complete data to support CMS's evaluation 
of the accrediting organization's performance. Data to be submitted 
includes, but is not limited to, accredited provider or supplier 
identifying information, survey schedules, survey findings, and notices 
of accreditation decisions. The organization must submit necessary data 
according to the instructions and timeframes CMS specifies.
    (12) The organization's procedures for responding to, and 
investigating, complaints against accredited facilities, including 
policies and procedures regarding referrals when applicable to 
appropriate licensing bodies and ombudsman programs.
    (13) The organization's accreditation status decision-making 
process, including its policies and procedures for granting, 
withholding, or removing accreditation status for facilities that fail 
to meet the accrediting organization's standards or requirements, 
assignment of less than full accreditation status or other actions taken 
by the organization in response to non-compliance with its standards and 
requirements. The organization must furnish the following:
    (i) A description of all types and categories of accreditation 
decisions associated with the program for which approval is sought, 
including the duration of each.
    (ii) A statement acknowledging that the organization agrees to 
notify CMS (in a manner CMS specifies) of any decision to revoke, 
withdraw, or revise the accreditation status of a specific deemed status 
provider or supplier, within three business days from the date the 
organization takes an action.
    (14) A list of all facilities currently accredited by the 
organization under the program for which CMS approval is sought, 
including the type and category of accreditation currently held by each 
provider or supplier, and the expiration date of each provider's or 
supplier's current accreditation.
    (15) A schedule of all surveys expected to be conducted by the 
organization for the accreditation program under review during the 6-
month period following submission of the application.
    (16) The three most recent audited financial statements of the 
organization that demonstrate that the organization's staffing, funding, 
and other resources are adequate to perform the required surveys and 
related activities.
    (17) A statement that it will:
    (i) Provide written notification to CMS and to all providers or 
suppliers accredited under a CMS-approved accreditation program at least 
90 calendar days in advance of the effective date of a decision by the 
organization

[[Page 278]]

to voluntarily terminate its CMS-approved accreditation program, 
including the implications for their deemed status in accordance with 
Sec. 488.8(g)(2);
    (ii) Adhere to the requirements for written notice to its accredited 
providers or suppliers at Sec. 488.8(e) in the case of an involuntary 
termination; and
    (iii) Include a written statement that if a fully accredited and 
deemed facility in good standing provides written notification that they 
wish to voluntarily withdraw from the accrediting organization's CMS-
approved accreditation program, the accrediting organization must 
continue the facility's current accreditation in full force and effect 
until the effective date of withdrawal identified by the facility or the 
expiration date of the term of accreditation, whichever comes first.
    (18) A statement that it will provide written notification to CMS of 
any proposed changes in the organization's CMS-approved accreditation 
program and that it agrees not to implement the proposed changes without 
prior written notice of continued program approval from CMS except as 
provided for at Sec. 488.8(b)(2).
    (19) A statement that, in response to a written notice from CMS to 
the organization of a change in the applicable conditions or 
requirements or in the survey process, the organization will provide CMS 
with proposed corresponding changes in the organization's requirements 
for its CMS-approved accreditation program to ensure continued 
comparability with the CMS conditions or requirements or survey process. 
The organization must comply with the following requirements:
    (i) The proposed changes must be submitted within 30 calendar days 
of the date of the written CMS notice to the organization or by a date 
specified in the notice, whichever is later. CMS will give due 
consideration to an organization's request for an extension of the 
deadline.
    (ii) The proposed changes will not be implemented without prior 
written notice of continued program approval from CMS, except as 
provided for at Sec. 488.8(b)(1)(iv).
    (20) A statement acknowledging that, as a condition for CMS's 
approval of an accreditation program, the organization will agree to 
permit its surveyors to serve as witnesses in a legal proceeding if CMS 
takes an adverse action against a provider or supplier on the basis of 
the organization's accreditation survey findings, and will cooperate 
with CMS to make surveyors and other staff available when needed.
    (21) A statement acknowledging that the organization agrees to make 
all Medicare cited deficiencies, both standard and condition level, 
immediate jeopardy situations, and dates of correction, for final 
accreditation survey reports publicly available on the organization's 
Web site within 90 days after the survey report is made available to 
those facilities for the most recent 3 years, on an ongoing basis in a 
manner specified by CMS. This acknowledgement includes all initial, 
triennial, full, follow-up, focused, and complaint surveys.
    (b) Additional information needed. If CMS determines that additional 
information is necessary to make a determination for approval or denial 
of the organization's initial application or re-application for CMS's 
approval of an accreditation program, CMS will notify the organization 
and afford it an opportunity to provide the additional information.
    (c)(1) Withdrawing an application. An accrediting organization may 
withdraw its initial application for CMS's-approval of its accreditation 
program at any time before CMS publishes the final notice described in 
paragraph (e)(2) of this section.
    (2) Voluntary termination of a CMS-approved accreditation program. 
An accrediting organization may voluntarily terminate its CMS-approved 
accreditation program at any time. The accrediting organization must 
notify CMS of its decision to voluntarily terminate its approved 
accreditation program at least 90 calendar days in advance of the 
effective date of the termination. In accordance with the requirement at 
Sec. 488.4(a)(17)(i), the accrediting organization must also provide 
written notice at least 90 days in advance of the effective date of the 
termination to each of its deemed status providers or suppliers.

[[Page 279]]

    (d) Re-submitting a request. (1) Except as provided in paragraph 
(d)(2) of this section, an organization whose request for CMS's approval 
or re-approval of an accreditation program has been denied may resubmit 
its application if the organization satisfies all of the following 
requirements:
    (i) Revises its accreditation program to address the issues related 
to the denial of its previous request.
    (ii) Demonstrates that it can provide reasonable assurance.
    (iii) Resubmits the application in its entirety.
    (2) If an accrediting organization has requested, in accordance with 
subpart D of this part, a reconsideration of CMS's determination that 
its request for approval of an accreditation program is denied, it may 
not submit a new application for approval of an accreditation program 
for the type of provider or supplier at issue in the reconsideration 
until the reconsideration is administratively final.
    (e) Public notice and comment. CMS publishes a notice in the Federal 
Register when the following conditions are met:
    (1) Proposed notice. When CMS receives a complete application from a 
national accrediting organization seeking CMS's approval of an 
accreditation program, it publishes a proposed notice. The proposed 
notice identifies the organization and the type of providers or 
suppliers to be covered by the accreditation program and provides 30 
calendar days for the public to submit comments to CMS.
    (2) Final notice. When CMS decides to approve or disapprove a 
national accrediting organization's application, it publishes a final 
notice within 210 calendar days from the date CMS determines the AO's 
applications was complete, unless the application was for a skilled 
nursing facility accreditation program. There is no timeframe for 
publication of a final notice for a national accrediting organization's 
application for approval of a skilled nursing facility accreditation 
program. The final notice specifies the basis for the CMS decision.
    (i) Approval or re-approval. If CMS approves or re-approves the 
accrediting organization's accreditation program, the final notices 
describes how the accreditation program provides reasonable assurance. 
The final notice specifies the effective date and term of the approval 
(which may not be later than the publication date of the notice and 
which will not exceed 6 years.
    (ii) Disapproval. If CMS does not approve the accrediting 
organization's accreditation program, the final notice describes, except 
in the case of a skilled nursing facility accreditation program, how the 
organization fails to provide reasonable assurance. In the case of an 
application for a skilled nursing facility accreditation program, 
disapproval may be based on the program's failure to provide reasonable 
assurance, or on CMS's decision to exercise its discretion in accordance 
with section 1865(a)(1)(B) of the Act. The final notice specifies the 
effective date of the decision.

[80 FR 29835, May 22, 2015, as amended at 82 FR 38516, Aug. 14, 2017; 82 
FR 46143, Oct. 4, 2017; 83 FR 56631, Nov. 13, 2018]



Sec. 488.6  Providers or suppliers that participate in the Medicaid
program under a CMS-approved accreditation program.

    A provider or supplier that has been granted ``deemed status'' by 
CMS by virtue of its accreditation from a CMS-approved accreditation 
program is eligible to participate in the Medicaid program if they are 
not required under Medicaid regulations to comply with any requirements 
other than Medicare participation requirements.

[80 FR 29837, May 22, 2015]



Sec. 488.7  Release and use of accreditation surveys.

    A Medicare participating provider or supplier deemed to meet program 
requirements in accordance with Sec. 488.4 must authorize its 
accrediting organization to release to CMS a copy of its most current 
accreditation survey and any information related to the survey that CMS 
may require (including, but not limited to, corrective action plans).
    (a) CMS may determine that a provider or supplier does not meet the 
applicable Medicare conditions or requirements on the basis of its own 
investigation of the accreditation survey

[[Page 280]]

or any other information related to the survey.
    (b) With the exception of home health agency surveys, general 
disclosure of an accrediting organization's survey information is 
prohibited under section 1865(b) of the Act. CMS may publically disclose 
an accreditation survey and information related to the survey, upon 
written request, to the extent that the accreditation survey and survey 
information are related to an enforcement action taken by CMS.

[80 FR 29837, May 22, 2015]



Sec. 488.8  Ongoing review of accrediting organizations.

    (a) Performance review. In accordance with section 1875(b) of the 
Act, CMS evaluates the performance of each CMS-approved accreditation 
program on an ongoing basis. This review includes, but is not limited to 
the following:
    (1) Review of the organization's survey activity.
    (2) Analysis of the results of the validation surveys under Sec. 
488.9(a)(1), including the rate of disparity between certifications of 
the accrediting organization and certifications of the SA.
    (3) Review of the organization's continued fulfillment of the 
requirements in Sec. 488.5(a).
    (b) Comparability review. CMS assesses the equivalency of an 
accrediting organization's CMS-approved program requirements to the 
comparable Medicare requirements if the following conditions exist:
    (1) CMS imposes new Medicare certification requirements or changes 
its survey process.
    (i) CMS provides written notice of the changes to the affected 
accrediting organization.
    (ii) CMS specifies in its written notice a timeframe, not less than 
30 calendar days from the date of the notice, for the accrediting 
organization to submit its proposed equivalent changes, including its 
implementation timeframe, for CMS review. CMS may extend the deadline 
after due consideration of a written request for extension by the 
accrediting organization, submitted prior to the original deadline.
    (iii) After completing the comparability review CMS provides written 
notification to the organization whether or not the accreditation 
program, including the proposed revisions and implementation timeframe, 
continues to meet or exceed all applicable Medicare requirements.
    (iv) If, no later than 60 calendar days after receipt of the 
organization's proposed changes, CMS does not provide the written notice 
to the organization required in paragraph (b)(1)(iii) of this section, 
then the revised program will be deemed to meet or exceed all applicable 
Medicare requirements and to have continued CMS approval.
    (v) If an organization fails to submit its proposed changes within 
the required timeframe, or fails to implement the proposed changes that 
have been determined by CMS or deemed to be comparable, CMS may open an 
accreditation program review in accordance with paragraph (c) of this 
section.
    (2) An accrediting organization proposes to adopt new requirements 
or to change its survey process.
    (i) An accrediting organization must provide written notice to CMS 
of any proposed changes in its accreditation requirements or survey 
process and must not implement any changes before receiving CMS's 
approval, except as provided below.
    (ii) If, no later than 60 calendar days after receipt of the 
organization's proposed changes, CMS does not provide written notice to 
the organization that the accreditation program, including the proposed 
revisions, continues or does not continue to meet or exceed all 
applicable Medicare requirements, then the revised program will be 
deemed to meet or exceed all applicable Medicare requirements and to 
have continued CMS approval.
    (iii) If an organization implements changes that have neither been 
determined by CMS nor deemed to be comparable to the applicable Medicare 
requirements, CMS may open an accreditation program review in accordance 
with paragraph (c) of this section.
    (c) CMS-approved accreditation program review. If a comparability or 
performance review reveals evidence of substantial non-compliance of an 
accrediting organization's CMS-approved accreditation program with the 
requirements of this subpart, CMS may

[[Page 281]]

initiate an accreditation program review.
    (1) If an accreditation program review is initiated, CMS provides 
written notice to the organization indicating that its CMS-approved 
accreditation program approval may be in jeopardy and that an 
accreditation program review is being initiated. The notice provides all 
of the following information:
    (i) A statement of the instances, rates or patterns of non-
compliance identified, as well as other related information, if 
applicable.
    (ii) A description of the process to be followed during the review, 
including a description of the opportunities for the accrediting 
organization to offer factual information related to CMS's findings.
    (iii) A description of the possible actions that may be imposed by 
CMS based on the findings of the accreditation program review.
    (iv) The actions the accrediting organization must take to address 
the identified deficiencies including a timeline for implementation not 
to exceed 180 calendar days after receipt of the notice that CMS is 
initiating an accreditation program review.
    (2) CMS reviews the accrediting organization's plan of correction 
for acceptability.
    (3) If CMS determines as a result of the accreditation program 
review or a review of an application for renewal of an existing CMS-
approved accreditation program that the accrediting organization has 
failed to meet any of the requirements of this subpart, CMS may place 
the accrediting organization's CMS-approved accreditation program on 
probation for a period up to 180 calendar days to implement corrective 
actions, not to exceed the accrediting organization's current term of 
approval. In the case of a renewal application where CMS has placed the 
accreditation program on probation, CMS indicates that any approval of 
the application is conditional while the program is placed on probation.
    (i) Within 60 calendar days after the end of any probationary 
period, CMS issues a written determination to the accrediting 
organization as to whether or not a CMS-approved accreditation program 
continues to meet the requirements of this subpart, including the 
reasons for the determination.
    (ii) If CMS has determined that the accrediting organization does 
not meet the requirements, CMS withdraws approval of the CMS-approved 
accreditation program. The notice of determination provided to the 
accrediting organization includes notice of the removal of approval, 
reason for the removal, including the effective date determined in 
accordance with paragraph (c)(3)(iii) of this section.
    (iii) CMS publishes in the Federal Register a notice of its decision 
to withdraw approval of a CMS-approved accreditation program, including 
the reasons for the withdrawal, effective 60 calendar days from the date 
of publication of the notice.
    (d) Immediate jeopardy. If at any time CMS determines that the 
continued approval of a CMS-approved accreditation program of any 
accrediting organization poses an immediate jeopardy to the patients of 
the entities accredited under that program, or the continued approval 
otherwise constitutes a significant hazard to the public health, CMS may 
immediately withdraw the approval of a CMS-approved accreditation 
program of that accrediting organization and publish a notice of the 
removal, including the reasons for it, in the Federal Register.
    (e) Notification of providers or suppliers. An accrediting 
organization whose CMS approval of its accreditation program has been 
withdrawn must notify, in writing, each of its accredited providers or 
suppliers of the withdrawal of CMS approval and the implications in 
accordance with paragraph (g)(1) of this section for the providers' or 
suppliers' deemed status no later than 30 calendar days after the notice 
is published in the Federal Register.
    (f) Request for reconsideration. Any accrediting organization 
dissatisfied with a determination to withdraw CMS approval of its 
accreditation program may request a reconsideration of that 
determination in accordance with subpart D of this part.
    (g) Continuation of deemed status--(1) Involuntary termination. 
After CMS removes approval of an accrediting organization's 
accreditation program, an affected provider's or supplier's deemed

[[Page 282]]

status continues in effect for 180 calendar days after the removal of 
the approval if the provider or supplier submits an application to 
another CMS-approved accreditation program within 60 calendar days from 
the date of publication of the removal notice in the Federal Register. 
The provider or supplier must also provide written notice to the SA that 
it has submitted an application for accreditation under another CMS-
approved accreditation program within this same 60-calendar day 
timeframe. Failure to comply with the timeframe requirements specified 
in this section will place the provider or supplier under the SAs 
authority for continued participation in Medicare and on-going 
monitoring.
    (2) Voluntary termination by accrediting organization. When an 
accrediting organization has voluntarily terminated its CMS-approved 
accreditation program and provides its accredited providers and 
suppliers the notice required at Sec. 488.5(a)(17), an affected 
provider's or supplier's deemed status continues in effect for 180 
calendar days after the termination effective date if the provider or 
supplier submits an application to another CMS-approved accreditation 
program within 60 calendar days from the date of the notice from the 
accrediting organization. The provider or supplier must also provide 
written notice to the SA that it has submitted an application for 
accreditation under another CMS-approved accreditation program within 
this same 60-calendar day timeframe. Failure to comply with the 
timeframe requirements specified in this section will place the provider 
or supplier under the SAs authority for continued participation in 
Medicare and on-going monitoring.
    (h) Onsite observations of accrediting organization operations. As 
part of the application review process, the ongoing review process, or 
the continuing oversight of an accrediting organization's performance, 
CMS may conduct at any time an onsite inspection of the accrediting 
organization's operations and offices to verify the organization's 
representations and to assess the organization's compliance with its own 
policies and procedures. The onsite inspection may include, but is not 
limited to, the review of documents, auditing meetings concerning the 
accreditation process, observation of surveys, the evaluation of survey 
results or the accreditation decision-making process, and interviews 
with the organization's staff.

[80 FR 29837, May 22, 2015]



Sec. 488.9  Validation surveys.

    (a) Basis for survey. CMS may require a survey of an accredited 
provider or supplier to validate the accrediting organization's CMS-
approved accreditation process. These surveys are conducted on a 
representative sample basis, or in response to substantial allegations 
of non-compliance.
    (1) For a representative sample, the survey may be comprehensive and 
address all Medicare conditions or requirements, or it may be focused on 
a specific condition(s) as determined by CMS.
    (2) For a substantial allegation of noncompliance, the SA surveys 
for any condition(s) or requirement(s) that CMS determines is related to 
the allegations.
    (b) Selection for survey. (1) A provider or supplier selected for a 
validation survey must cooperate with the SA that performs the 
validation survey.
    (2) If a provider or supplier selected for a validation survey fails 
to cooperate with the SA, it will no longer be deemed to meet the 
Medicare conditions or requirements, but will be subject to a review by 
the SA in accordance with Sec. 488.10(a), and may be subject to 
termination of its provider agreement under Sec. 489.53 of this 
chapter.
    (c) Consequences of a finding of non-compliance. (1) If a CMS 
validation survey results in a finding that the provider or supplier is 
out of compliance with one or more Medicare conditions or requirements, 
the provider or supplier will no longer be deemed to meet the Medicare 
conditions or requirements and will be subject to ongoing review by the 
SA in accordance with Sec. 488.10(a) until the provider or supplier 
demonstrates compliance.
    (2) CMS may take actions for the deficiencies identified in the 
state validation survey in accordance with Sec. 488.24, or may first 
direct the SA to conduct

[[Page 283]]

another survey of the provider's or supplier's compliance with specified 
Medicare conditions or requirements before taking the enforcement 
actions provided for at Sec. 488.24.
    (3) If CMS determines that a provider or supplier is not in 
compliance with applicable Medicare conditions or requirements, the 
provider or supplier may be subject to termination of the provider or 
supplier agreement under Sec. 489.53 of this chapter or of the supplier 
agreement in accordance with the applicable supplier conditions and any 
other applicable intermediate sanctions and remedies.
    (d) Re-instating deemed status. An accredited provider or supplier 
will be deemed to meet the applicable Medicare conditions or 
requirements in accordance with this section if all of the following 
requirements are met:
    (1) It withdraws any prior refusal to authorize its accrediting 
organization to release a copy of the provider's or supplier's current 
accreditation survey.
    (2) It withdraws any prior refusal to allow a validation survey, if 
applicable.
    (3) CMS finds that the provider or supplier meets all applicable 
Medicare CoP, CfC, conditions of certification, or requirements.
    (e) Impact of adverse actions. The existence of any performance 
review, comparability review, deemed status review, probationary period, 
or any other action by CMS, does not affect or limit conducting any 
validation survey.

[80 FR 29839, May 22, 2015]



Sec. 488.10  State survey agency review: Statutory provisions.

    (a) Section 1864(a) of the Act requires the Secretary to enter into 
an agreement with any State that is able and willing to do so, under 
which appropriate State or local survey agencies will determine whether:
    (1) Providers or prospective providers meet the Medicare conditions 
of participation or requirements (for SNFs and NFs);
    (2) Suppliers meet the conditions for coverage; and
    (3) Rural health clinics meet the conditions of certification.
    (b) Section 1865(a) of the Act provides that if an institution is 
accredited by a national accrediting organization recognized by the 
Secretary, it may be deemed to have met the applicable conditions or 
requirements.
    (c) Section 1864(c) of the Act authorizes the Secretary to enter 
into agreements with state survey agencies for the purpose of conducting 
validation surveys in institutions accredited by an accreditation 
program recognized by the Secretary.
    (d) Section 1865(c) provides that an accredited institution that is 
found after a validation survey to have significant deficiencies related 
to health and safety of patients will no longer meet the applicable 
conditions or requirements.

[53 FR 22859, June 17, 1988, as amended at 56 FR 48879, Sept. 26, 1991; 
58 FR 61842, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997; 80 FR 29839, May 
22, 2015]



Sec. 488.11  State survey agency functions.

    State and local agencies that have agreements under section 1864(a) 
of the Act perform the following functions:
    (a) Survey and make recommendations regarding the issues listed in 
Sec. 488.10.
    (b) Conduct validation surveys of deemed status providers and 
suppliers as provided in Sec. 488.9.
    (c) Perform other surveys and carry out other appropriate activities 
and certify their findings to CMS.
    (d) Make recommendations regarding the effective dates of provider 
agreements and supplier approvals in accordance with Sec. 489.13 of 
this chapter.

[62 FR 43936, Aug. 18, 1997, as amended at 80 FR 29839, May 22, 2015]



Sec. 488.12  Effect of survey agency certification.

    Certifications by the State survey agency represent recommendations 
to CMS.
    (a) On the basis of these recommendations, CMS will determine 
whether:
    (1) A provider or supplier is eligible to participate in or be 
covered under the Medicare program; or
    (2) A provider or supplier accredited under a CMS-approved 
accreditation program remains deemed to meet the Medicare conditions or 
requirements, or will be placed under the jurisdiction

[[Page 284]]

of the SA and subject to further enforcement actions in accordance with 
the provisions at Sec. 488.9.
    (b) Notice of CMS's determination will be sent to the provider or 
supplier.

[53 FR 22859, June 17, 1988, as amended at 80 FR 29839, May 22, 2015]



Sec. 488.13  Loss of accreditation.

    If an accrediting organization notifies CMS that it is terminating a 
provider or supplier due to non-compliance with its CMS-approved 
accreditation requirements, the SA will conduct a full review in a 
timely manner.

[80 FR 29839, May 22, 2015]



Sec. 488.14  Effect of QIO review.

    When a QIO is conducting review activities under section 1154 of the 
Act and part 466 of this chapter, its activities are in lieu of the 
utilization review and evaluation activities required of health care 
institutions under sections 1861(e)(6), and 1861(k) of the Act.

[59 FR 56237, Nov. 10, 1994]



Sec. 488.18  Documentation of findings.

    (a) The findings of the State agency with respect to each of the 
conditions of participation, requirements (for SNFs and NFs), or 
conditions for coverage must be adequately documented. When the State 
agency certifies to the Secretary that a provider or supplier is not in 
compliance with the conditions or requirements (for SNFs and NFs), and 
therefore not eligible to participate in the program, such documentation 
includes, in addition to the description of the specific deficiencies 
which resulted in the agency's recommendation, any provider or supplier 
response.
    (b) If a provider or supplier is certified by the State agency as in 
compliance with the conditions or participation requirements (for SNFs 
and NFs) or as meeting the requirements for special certification (see 
Sec. 488.54), with deficiencies not adversely affecting the health and 
safety of patients, the following information will be incorporated into 
the finding:
    (1) A statement of the deficiencies that were found.
    (2) A description of further action that is required to remove the 
deficiencies.
    (3) A time-phased plan of correction developed by the provider and 
supplier and concurred with by the State agency.
    (4) A scheduled time for a resurvey of the institution or agency to 
be conducted by the State agency within 90 days following the completion 
of the survey.
    (c) If, on the basis of the State certification, the Secretary 
determines that the provider or supplier is eligible to participate, the 
information described in paragraph (b) of this section will be 
incorporated into a notice of eligibility to the provider or supplier.
    (d) If the State agency receives information to the effect that a 
hospital or a critical access hospital (as defined in section 
1861(mm)(1) of the Act) has violated Sec. 489.24 of this chapter, the 
State agency is to report the information to CMS promptly.

[39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, 
and further redesignated at 42 FR 52826, Sept. 30, 1977. Redesignated at 
53 FR 23100, June 17, 1988; 59 FR 32120, June 22, 1994; 59 FR 56237, 
Nov. 10, 1994; 62 FR 46037, Aug. 29, 1997]

    Effective Date Note: At 59 FR 32120, June 22, 1994, Sec. 488.18(d) 
was added. This paragraph contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.



Sec. 488.20  Periodic review of compliance and approval.

    (a) Determinations by CMS to the effect that a provider or supplier 
is in compliance with the conditions of participation, or requirements 
(for SNFs and NFs), or the conditions for coverage are made as often as 
CMS deems necessary and may be more or less than a 12-month period, 
except for SNFs, NFs and HHAs. (See Sec. 488.308 for special rules for 
SNFs and NFs.)
    (b) The responsibilities of State survey agencies in the review and 
certification of compliance are as follows:
    (1) Resurvey providers or suppliers as frequently as necessary to 
ascertain compliance and confirm the correction of deficiencies;

[[Page 285]]

    (2) Review reports prepared by a Professional Standards Review 
Organization (authorized under Part B Title XI of the Act) or a State 
inspection of care team (authorized under Title XIX of the Act) 
regarding the quality of a facility's care;
    (3) Evaluate reports that may pertain to the health and safety of 
patients; and
    (4) Take appropriate actions that may be necessary to achieve 
compliance or certify noncompliance to CMS.
    (c) A State survey agency certification to CMS that a provider or 
supplier is no longer in compliance with the conditions of participation 
or requirements (for SNFs and NFs) or conditions for coverage will 
supersede the State survey agency's previous certification.

(Secs. 1102, 1814, 1861, 1863 through 1866, 1871, and 1881; 42 U.S.C. 
1302, 1395f, 1395x, 1395z through 1395cc, 1395hh, and 1395rr)

[45 FR 74833, Nov. 12, 1981. Redesignated and amended at 53 FR 23100, 
June 17, 1988, and further amended at 54 FR 5373, Feb. 2, 1989; 56 FR 
48879, Sept. 26, 1991; 59 FR 56237, Nov. 10, 1994]



Sec. 488.24  Certification of noncompliance.

    (a) Special rules for certification of noncompliance for SNFs and 
NFs are set forth in Sec. 488.330.
    (b) The State agency will certify that a provider or supplier is not 
or is no longer in compliance with the conditions of participation or 
conditions for coverage where the deficiencies are of such character as 
to substantially limit the provider's or supplier's capacity to furnish 
adequate care or which adversely affect the health and safety of 
patients; or
    (c) If CMS determines that an institution or agency does not qualify 
for participation or coverage because it is not in compliance with the 
conditions of participation or conditions for coverage, or if a 
provider's agreement is terminated for that reason, the institution or 
agency has the right to request that the determination be reviewed. 
(Appeals procedures are set forth in part 498 of this chapter.)

[59 FR 56237, Nov. 10, 1994]



Sec. 488.26  Determining compliance.

    (a) Additional rules for certification of compliance for SNFs and 
NFs are set forth in Sec. 488.330.
    (b) The decision as to whether there is compliance with a particular 
requirement, condition of participation, or condition for coverage 
depends upon the manner and degree to which the provider or supplier 
satisfies the various standards within each condition. Evaluation of a 
provider's or supplier's performance against these standards enables the 
State survey agency to document the nature and extent of deficiencies, 
if any, with respect to a particular function, and to assess the need 
for improvement in relation to the prescribed conditions.
    (c) The State survey agency must adhere to the following principles 
in determining compliance with participation requirements:
    (1) The survey process is the means to assess compliance with 
Federal health, safety and quality standards;
    (2) The survey process uses resident and patient outcomes as the 
primary means to establish the compliance process of facilities and 
agencies. Specifically, surveyors will directly observe the actual 
provision of care and services to residents and/or patients, and the 
effects of that care, to assess whether the care provided meets the 
needs of individual residents and/or patients.
    (3) Surveyors are professionals who use their judgment, in concert 
with Federal forms and procedures, to determine compliance;
    (4) Federal procedures are used by all surveyors to ensure uniform 
and consistent application and interpretation of Federal requirements;
    (5) Federal forms are used by all surveyors to ensure proper 
recording of findings and to document the basis for the findings.
    (d) The State survey agency must use the survey methods, procedures, 
and forms that are prescribed by CMS.
    (e) The State survey agency must ensure that a facility's or 
agency's actual provision of care and services to residents and patients 
and the effects of

[[Page 286]]

that care on such residents and patients are assessed in a systematic 
manner.

[59 FR 56237, Nov. 10, 1994, as amended at 77 FR 67164, Nov. 8, 2012]



Sec. 488.28  Providers or suppliers, other than SNFs, NFs, and HHAs
with deficiencies.

    (a) If a provider or supplier is found to be deficient in one or 
more of the standards in the conditions of participation, conditions for 
coverage, or conditions for certification or requirements, it may 
participate in, or be covered under, the Medicare program only if the 
provider or supplier has submitted an acceptable plan of correction for 
achieving compliance within a reasonable period of time acceptable to 
CMS. In the case of an immediate jeopardy situation, CMS may require a 
shorter time period for achieving compliance.
    (b) The existing deficiencies noted either individually or in 
combination neither jeopardize the health and safety of patients nor are 
of such character as to seriously limit the provider's capacity to 
render adequate care.
    (c)(1) If it is determined during a survey that a provider or 
supplier is not in compliance with one or more of the standards, it is 
granted a reasonable time to achieve compliance.
    (2) The amount of time depends upon the--
    (i) Nature of the deficiency; and
    (ii) State survey agency's judgment as to the capabilities of the 
facility to provide adequate and safe care.
    (d) Ordinarily a provider or supplier is expected to take the steps 
needed to achieve compliance within 60 days of being notified of the 
deficiencies but the State survey agency may recommend that additional 
time be granted by the Secretary in individual situations, if in its 
judgment, it is not reasonable to expect compliance within 60 days, for 
example, a facility must obtain the approval of its governing body, or 
engage in competitive bidding.

[59 FR 56237, Nov. 10, 1994, as amended at 77 FR 67164, Nov. 8, 2012; 80 
FR 29839, May 22, 2015]



Sec. 488.30  Revisit user fee for revisit surveys.

    (a) Definitions. As used in this section, the following definitions 
apply:
    Certification (both initial and recertification) means those 
activities as defined in Sec. 488.1.
    Complaint surveys means those surveys conducted on the basis of a 
substantial allegation of noncompliance, as defined in Sec. 488.1. The 
requirements of sections 1819(g)(4) and 1919(g)(4) of the Social 
Security Act and Sec. 488.332 apply to complaint surveys.
    Provider of services, provider, or supplier has the meaning defined 
in Sec. 488.1, and ambulatory surgical centers, transplant programs, 
and religious nonmedical health care institutions subject to Sec. Sec. 
416.2, 482.70, and 403.702 [C8] of this chapter, respectively, will be 
subject to user fees unless otherwise exempted.
    Revisit survey means a survey performed with respect to a provider 
or supplier cited for deficiencies during an initial certification, 
recertification, or substantiated complaint survey and that is designed 
to evaluate the extent to which previously-cited deficiencies have been 
corrected and the provider or supplier is in substantial compliance with 
applicable conditions of participation, requirements, or conditions for 
coverage. Revisit surveys include both offsite and onsite review.
    Substantiated complaint survey means a complaint survey that results 
in the proof or finding of noncompliance at the time of the survey, a 
finding that noncompliance was proven to exist, but was corrected prior 
to the survey, and includes any deficiency that is cited during a 
complaint survey, whether or not the cited deficiency was the original 
subject of the complaint.
    (b) Criteria for determining the fee. (1) The provider or supplier 
will be assessed a revisit user fee based upon one or more of the 
following:
    (i) The average cost per provider or supplier type.
    (ii) The type of revisit survey conducted (onsite or offsite).
    (iii) The size of the provider or supplier.
    (iv) The number of follow-up revisits resulting from uncorrected 
deficiencies.

[[Page 287]]

    (v) The seriousness and number of deficiencies.
    (2) CMS may adjust the fees to account for any regional differences 
in cost.
    (c) Fee schedule. CMS must publish in the Federal Register the 
proposed and final notices of a uniform fee schedule before it assesses 
revised revisit user fees. The notices must set forth which criteria 
will be used and how, as well as the amounts of the assessed fees based 
on the criteria as identified in paragraph (b) of this subpart.
    (d) Collection of fees. (1) Fees for revisit surveys under this 
section may be deducted from amounts otherwise payable to the provider 
or supplier. As they are collected, fees will be deposited as an offset 
collection to be used exclusively for survey and certification 
activities conducted by State survey agencies pursuant to section 1864 
of the Act or by CMS, and will be available for CMS until expended. CMS 
may devise other collection methods as it deems appropriate. In 
determining these methods, CMS will consider efficiency, effectiveness, 
and convenience for the providers, suppliers, and CMS. CMS may consider 
any method allowed by law, including: Credit card; electronic fund 
transfer; check; money order; and offset collections from claims 
submitted.
    (2) Fees for revisit surveys under this section are not allowable 
items on a cost report, as identified in part 413, subpart B of this 
chapter, under title XVIII of the Act.
    (3) Fees for revisit surveys will be due for any revisit surveys 
conducted during the time period for which authority to levy a revisit 
user fee exists.
    (e) Reconsideration process for revisit user fees. (1) CMS will 
review a request for reconsideration of an assessed revisit user fee--
    (i) If a provider or supplier believes an error of fact has been 
made in the application of the revisit user fee, such as clerical 
errors, billing for a fee already paid, or assessment of a fee when 
there was no revisit conducted, and
    (ii) If the request for reconsideration is received by CMS within 14 
calendar days from the date identified on the revisit user fee 
assessment notice.
    (2) CMS will issue a credit toward any future revisit surveys 
conducted, if the provider or supplier has remitted an assessed revisit 
user fee and for which a reconsideration request is found in favor of 
the provider or supplier. If in the event that CMS judges that a 
significant amount of time has elapsed before such a credit is used, CMS 
will refund the assessed revisit user fee amount paid to the provider or 
supplier.
    (3) CMS will not reconsider the assessment of revisit user fees that 
request reconsideration of the survey findings or deficiency citations 
that may have given rise to the revisit, the revisit findings, the need 
for the revisit itself, or other similarly identified basis for the 
assessment of the revisit user fee.
    (f) Enforcement. If the full revisit user fee payment is not 
received within 30 calendar days from the date identified on the revisit 
user fee assessment notice, CMS may terminate the facility's provider 
agreement (pursuant to Sec. 489.53(a)(16) of this chapter) and 
enrollment in the Medicare program or the supplier's enrollment and 
participation in the Medicare program (pursuant to Sec. 424.535(a)(1) 
of this chapter).

[72 FR 53648, Sept. 19, 2007, as amended at 82 FR 36635, Aug. 4, 2017; 
84 FR 51831, Sept. 30, 2019]



                     Subpart B_Special Requirements



Sec. 488.52  [Reserved]



Sec. 488.54  Temporary waivers applicable to hospitals.

    (a) General provisions. If a hospital is found to be out of 
compliance with one or more conditions of participation for hospitals, 
as specified in part 482 of this chapter, a temporary waiver may be 
granted by CMS. CMS may extend a temporary waiver only if such a waiver 
would not jeopardize or adversely affect the health and safety of 
patients. The waiver may be issued for any one year period or less under 
certain circumstances. The waiver may be withdrawn earlier if CMS 
determines this action is necessary to protect the health and safety of 
patients. A waiver may be granted only if:

[[Page 288]]

    (1) The hospital is located in a rural area. This includes all areas 
not delineated as ``urban'' by the Bureau of the Census, based on the 
most recent census;
    (2) The hospital has 50 or fewer inpatient hospital beds;
    (3) The character and seriousness of the deficiencies do not 
adversely affect the health and safety of patients; and
    (4) The hospital has made and continues to make a good faith effort 
to comply with personnel requirements consistent with any waiver.
    (b) Minimum compliance requirements. Each case will have to be 
decided on its individual merits, and while the degree and extent of 
compliance will vary, the institution must, as a minimum, meet all of 
the statutory conditions in section 1861(e)(1)-(8), in addition to 
meeting such other requirements as the Secretary finds necessary under 
section 1861(e)(9). (For further information relating to the exception 
in section 1861(e)(5) of the Act, see paragraph (c) of this section.)
    (c) Temporary waiver of 24-hour nursing requirement of 24-hour 
registered nurse requirement. CMS may waive the requirement contained in 
section 1861(e)(5) that a hospital must provide 24-hour nursing service 
furnished or supervised by a registered nurse. Such a waiver may be 
granted when the following criteria are met:
    (1) The hospital's failure to comply fully with the 24-hour nursing 
requirement is attributable to a temporary shortage of qualified nursing 
personnel in the area in which the hospital is located.
    (2) A registered nurse is present on the premises to furnish or 
supervise the nursing services during at least the daytime shift, 7 days 
a week.
    (3) The hospital has in charge, on all tours of duty not covered by 
a registered nurse, a licensed practical (vocational) nurse.
    (4) The hospital complies with all requirements specified in 
paragraph (a) of this section.
    (d) Temporary waiver for technical personnel. CMS may waive 
technical personnel requirements, issued under section 1861(e)(9) of the 
Act, contained in the Conditions of Participation; Hospitals (part 482 
of this chapter). Such a waiver must take into account the availability 
of technical personnel and the educational opportunities for technical 
personnel in the area in which the hospital is located. CMS may also 
limit the scope of services furnished by a hospital in conjunction with 
the waiver in order not to adversely affect the health and safety of the 
patients. In addition, the hospital must also comply with all 
requirements specified in paragraph (a) of this section.

[39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, 
and amended at 41 FR 27962, July 8, 1976. Further redesignated at 42 FR 
52826, Sept. 30, 1977, and amended at 47 FR 31531, July 20, 1982; 51 FR 
22041, June 17, 1986. Redesignated at 53 FR 23100, June 17, 1988]



Sec. 488.56  Temporary waivers applicable to skilled nursing facilities.

    (a) Waiver of 7-day registered nurse requirement. To the extent that 
Sec. 483.35 of this chapter requires any skilled nursing facility to 
engage the services of a registered nurse more than 40 hours a week, the 
Secretary may waive such requirement for such periods as he deems 
appropriate if, based upon documented findings of the State agency, he 
determines that:
    (1) Such facility is located in a rural area and the supply of 
skilled nursing facility services in such area is not sufficient to meet 
the needs of individual patients therein,
    (2) Such facility has at least one fulltime registered nurse who is 
regularly on duty at such facility 40 hours a week, and
    (3) Such facility (i) has only patients whose attending physicians 
have indicated (through physicians' orders or admission notes) that each 
such patient does not require the services of a registered nurse for a 
48-hour period, or (ii) has made arrangements for a registered nurse or 
a physician to spend such time at the facility as is determined 
necessary by the patient's attending physician to provide necessary 
services on days when the regular fulltime registered nurse is not on 
duty.
    (4) Such facility has made and continues to make a good faith effort 
to comply with the more than 40-hour registered nurse requirement, but 
such

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compliance is impeded by the unavailability of registered nurses in the 
area.
    (b) Waiver of medical director requirement. To the extent that Sec. 
483.70(h) of this chapter requires any skilled nursing facility to 
engage the services of a medical director either part-time or full-time, 
the Secretary may waive such requirement for such periods as he deems 
appropriate if, based upon documented findings of the State agency, he 
determines that:
    (1) Such facility is located in an area where the supply of 
physicians is not sufficient to permit compliance with this requirement 
without seriously reducing the availability of physician services within 
the area, and
    (2) Such facility has made and continues to make a good faith effort 
to comply with Sec. 483.70(h) of this chapter, but such compliance is 
impeded by the unavailability of physicians in the area.

[39 FR 35777, Oct. 3, 1974. Redesignated and amended at 42 FR 52826, 
Sept. 30, 1977. Further redesignated and amended at 53 FR 23100, June 
17, 1988, and further amended at 56 FR 48879, Sept. 26, 1991; 57 FR 
43925, Sept. 23, 1992; 81 FR 68871, Oct. 4, 2016; 82 FR 32260, July 13, 
2017]



Sec. 488.60  Special procedures for approving end stage renal disease 
facilities.

    (a) Consideration for approval. An ESRD facility that wishes to be 
approved or that wishes an expansion of dialysis services to be approved 
for coverage, in accordance with part 494 of this chapter, must secure a 
determination by the Secretary. To secure a determination, the facility 
must submit the following documents and data for consideration by the 
Secretary:
    (1) Certification by the State agency referred to in Sec. 488.12 of 
this part.
    (2) Data furnished by ESRD network organizations and recommendations 
of the Public Health Service concerning the facility's contribution to 
the ESRD services of the network.
    (3) Data concerning the facility's compliance with professional 
norms and standards.
    (4) Data pertaining to the facility's qualifications for approval or 
for any expansion of services.
    (b) Determining compliance with minimal utilization rates: Time 
limitations--(1) Unconditional status. A facility which meets minimal 
utilization requirements will be assigned this status as long as it 
continues to meet these requirements.
    (2) Conditional status. A conditional status may be granted to a 
facility for not more than four consecutive calendar years and will not 
be renewable (see Sec. 405.2122(b) of this chapter). Its status may be 
examined each calendar year to ascertain its compliance with Subpart U.
    (3) Exception status. Under unusual circumstances (see Sec. 
405.2122 (b) of this chapter) the Secretary may grant a time-limited 
exception to a facility which is not in compliance with the minimal 
utilization rate(s) for either unconditional status or conditional 
status. This exception status may be granted, and may be renewed on an 
annual basis, under circumstances where rigid application of minimal 
utilization rate requirements would adversely affect the achievement of 
ESRD program objectives.
    (c) New applicant. A facility which has not previously participated 
in the ESRD program must submit a plan detailing how it expects to meet 
the conditional minimal utilization rate status by the end of the second 
calendar year of its operation under the program and meet the 
unconditional minimal utilization rate status by the end of the fourth 
calendar year of its operation under the program.
    (d) Notification. The Secretary will notify each facility and its 
network coordinating council of its initial and its subsequent minimal 
utilization rate classification.
    (e) Failure to meet minimal utilization rate. A facility failing to 
meet standards for unconditional status or conditional status, or if 
applicable, for exception status, will be so notified at the time of 
such classification.
    (f) Interim regulations participant. A facility previously 
participating under the interim regulations will not be approved under 
the program established by subpart U until it has demonstrated that it 
meets all the applicable requirements of this subpart, including the 
appropriate minimal utilization rate. It may continue under the interim 
program only for a period not to

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exceed 1 year from the effective date of these amendments (see Sec. 
405.2100(c) of this chapter). During this period it may demonstrate its 
ability to meet the appropriate minimal utilization rate. Failure to 
qualify under this subpart will automatically terminate coverage of such 
facility's services under the ESRD program at the end of such year.

[41 FR 22510, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and further amended at 45 FR 58124, Sept. 2, 1980. Redesignated and 
amended at 53 FR 23100, June 17, 1988; 73 FR 20474, Apr. 15, 2008]



Sec. 488.61  Special procedures for approval and re-approval of organ
transplant programs.

    For the purposes of this subpart, the survey, certification, and 
enforcement procedures described at 42 CFR part 488, subpart A apply to 
transplant programs, including the periodic review of compliance and 
approval described at Sec. 488.20.
    (a) Initial approval procedures for transplant programs that are not 
Medicare-approved as of June 28, 2007. A transplant program, including a 
kidney transplant program, may submit a request to CMS for Medicare 
approval at any time.
    (1) The request, signed by a person authorized to represent the 
center (for example, a chief executive officer), must include:
    (i) The hospital's Medicare provider I.D. number;
    (ii) Name(s) of the designated primary transplant surgeon and 
primary transplant physician; and,
    (iii) A statement from the OPTN that the center has complied with 
all data submission requirements.
    (2) To determine compliance with the clinical experience and outcome 
requirements at Sec. Sec. 482.80(b) and 482.80(c), CMS will review the 
data contained in the most recent OPTN Data Report and 1-year patient 
and graft survival data contained in the most recent Scientific Registry 
of Transplant Recipient (SRTR) program-specific report.
    (3) If CMS determines that a transplant center has not met the data 
submission, clinical experience, or outcome requirements, CMS may deny 
the request for approval or may review the center's compliance with the 
conditions of participation at Sec. Sec. 482.72 through 482.76 and 
Sec. Sec. 482.90 through 482.104 of this chapter, using the procedures 
described at 42 CFR part 488, subpart A, to determine whether the 
center's request will be approved. CMS will notify the transplant center 
in writing whether it is approved and, if approved, of the effective 
date of its approval.
    (4) CMS will consider mitigating factors in accordance with 
paragraphs (f), (g), and (h) of this section.
    (5) If CMS determines that a transplant program has met the data 
submission, clinical experience, and outcome requirements, CMS will 
review the program's compliance with the conditions of participation 
contained at Sec. Sec. 482.72 through 482.76 and Sec. Sec. 482.90 
through 482.104 of this chapter using the procedures described in 
subpart A of this part. If the transplant program is found to be in 
compliance with all the conditions of participation at Sec. Sec. 482.72 
through 482.104 of this chapter, CMS will notify the transplant program 
in writing of the effective date of its Medicare-approval. CMS will 
notify the transplant program in writing if it is not Medicare-approved.
    (6) A kidney transplant center may submit a request for initial 
approval after performing at least 3 transplants over a 12-month period.
    (b) Initial approval procedures for transplant centers, including 
kidney transplant centers, that are Medicare approved as of June 28, 
2007. (1) A transplant center that wants to continue to be Medicare 
approved must be in compliance with the conditions of participation at 
Sec. Sec. 482.72 through 482.104 as of June 28, 2007 and submit a 
request to CMS for Medicare approval under the conditions of 
participation no later than December 26, 2007, using the process 
described in paragraph (a)(1) of the section.
    (2) CMS will determine whether to approve the transplant center, 
using the procedures described in paragraphs (a)(2) through (a)(5) of 
this section. Until CMS makes a determination whether to approve the 
transplant center under the conditions of participation at Sec. Sec. 
482.72 through 482.104, the transplant center will continue to be

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Medicare approved under the end stage renal disease (ESRD) conditions 
for coverage (CfCs) in part 405, subpart U of this chapter for kidney 
transplant centers or the pertinent national coverage decisions (NCDs) 
for extra-renal organ transplant centers, as applicable, and the 
transplant center will continue to be reimbursed for services provided 
to Medicare beneficiaries.
    (3) Once CMS approves a kidney transplant center under the 
conditions of participation, the ESRD CfCs no longer apply to the center 
as of the date of its approval. Once CMS approves an extra-renal organ 
transplant center under the conditions of participation, the NCDs no 
longer apply to the center as of the date of its approval.
    (4) If a transplant center that is Medicare approved as of June 28, 
2007 submits a request for approval under the CoPs at Sec. Sec. 482.72 
through 482.104 of this chapter but CMS does not approve the transplant 
center, or if the transplant center does not submit its request to CMS 
for Medicare approval under the CoPs by December 26, 2007, CMS will 
revoke the transplant center's approval under the conditions for 
coverage for kidney transplant centers or the national coverage 
decisions for extra-renal transplant centers, as applicable, and the 
transplant center will no longer be reimbursed for services provided to 
Medicare beneficiaries. CMS will notify the transplant center in writing 
of the effective date of its loss of Medicare approval.
    (c) Loss of Medicare approval. Programs that have lost their 
Medicare approval may seek re-entry into the Medicare program at any 
time. A program that has lost its Medicare approval must:
    (1) Request initial approval using the procedures described in 
paragraph (a) of this section;
    (2) Be in compliance with Sec. Sec. 482.72 through 482.104 of this 
chapter at the time of the request for Medicare approval; and
    (3) Submit a report to CMS documenting any changes or corrective 
actions taken by the program as a result of the loss of its Medicare 
approval status.
    (d) Transplant program inactivity. A transplant program may remain 
inactive and retain its Medicare approval for a period not to exceed 12 
months. A transplant program must notify CMS upon its voluntary 
inactivation as required by Sec. 482.74(a)(3) of this chapter.
    (e) Consideration of mitigating factors in initial approval survey, 
certification, and enforcement actions for transplant programs--(1) 
Factors. Except for situations of immediate jeopardy or deficiencies 
other than failure to meet requirements at Sec. 482.80 of this chapter, 
CMS will consider such mitigating factors as may be appropriate in light 
of the nature of the deficiency and circumstances, including (but not 
limited to) the following, in making a decision of initial approval of a 
transplant program that does not meet the data submission, clinical 
experience, or outcome requirements:
    (i) The extent to which outcome measures are not met or exceeded;
    (ii) Availability of Medicare-approved transplant centers in the 
area;
    (iii) Extenuating circumstances (for example, natural disaster) that 
have a temporary effect on meeting the conditions of participation;
    (iv) Program improvements that substantially address root causes of 
graft failures or patient deaths, that have been implemented and 
institutionalized on a sustainable basis, and that are supported by 
outcomes more recent than the latest available SRTR report, for which 
there is a sufficient post-transplant patient and graft survival period 
and a sufficient number of transplants such that CMS finds that the 
program demonstrates present-day compliance with the requirements at 
Sec. 482.80(c)(2)(ii)(C) of this chapter;
    (v) Whether the program has made extensive use of innovative 
transplantation practices relative to other transplant programs, such as 
a high rate of transplantation of individuals who are highly sensitized 
or children who have undergone a Fontan procedure compared to most other 
transplant programs, where CMS finds that the innovative practices are 
supported by evidence-based published research literature or nationally 
recognized standards or Institution Review Board

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(IRB) approvals, and the SRTR risk-adjustment methodology does not take 
the relevant key factors into consideration; and
    (vi) Whether the program's performance, based on the OPTN method of 
calculating patient and graft survival, is within the OPTN's thresholds 
for acceptable performance and does not flag OPTN performance review 
under the applicable OPTN policy.
    (2) Content. A request for consideration of mitigating factors must 
include sufficient information to permit an adequate review and 
understanding of the transplant program, the factors that have 
contributed to outcomes, program improvements or innovations that have 
been implemented or planned, and in the case of natural disasters, the 
recovery actions planned. Examples of information to be submitted with 
each request include (but are not limited to) the following:
    (i) The name and contact information for the transplant hospital and 
the names and roles of key personnel of the transplant program;
    (ii) The type of organ transplant program(s) for which approval is 
requested;
    (iii) The conditions of participation that the program does not meet 
for which the transplant center is requesting CMS' review for mitigating 
factors;
    (iv) The program's organizational chart with full-time equivalent 
levels, roles, and structure for reporting to hospital leadership;
    (v) For applications involving substandard patient or graft 
survival, the rationale and supporting evidence for CMS' review 
includes, but is not limited to--
    (A) Root Cause Analysis for patient deaths and graft failures, 
including factors the program has identified as likely causal or 
contributing factors for patient deaths and graft failures;
    (B) Program improvements that have been implemented and improvements 
that are planned;
    (C) Patient and donor/organ selection criteria and evaluation 
protocols, including methods for pre-transplant patient evaluation by 
cardiologists, hematologists, nephrologists, and psychiatrists or 
psychologists to the extent applicable;
    (D) Waitlist management protocols and practices relevant to 
outcomes;
    (E) Pre-operative management protocols and practices;
    (F) Immunosuppression/infection prophylaxis protocols;
    (G) Post-transplant monitoring and management protocols and 
practices;
    (H) Quality Assessment and Performance Improvement (QAPI) Program 
meeting minutes from the most recent four meetings and attendance 
rosters from the most recent 12 months;
    (I) Quality dashboard and other performance indicators; and
    (J) The most recent data regarding transplants that have been made 
and for outcomes in terms of both patient survival and graft survival;
    (vi) For mitigating factors requests based on innovative practice:
    (A) A description of the innovations that have been implemented and 
identification of the specific cases for which the innovative practices 
are relevant so as to enable the patient and graft survival data for 
such cases to be compared with all other transplants for at least the 
period covered by the latest available SRTR report.
    (B) The literature, research, or other evidentiary basis that 
supports consideration of the practice(s) as innovative.
    (vii) For requests based on natural disasters or public health 
emergency:
    (A) A description of the disaster or emergency, the specific impact 
on the program, the time periods of the event(s) and of its immediate 
recovery aftermath;
    (B) Identification of the transplants that occurred during the 
period for which the request is being made; and
    (C) The approximate date when the program believes it substantially 
recovered from the event(s), or believes it will recover if substantial 
recovery has not been accomplished at the time of the request.
    (3) Timing. Within 14 calendar days after CMS has issued formal 
written notice of a condition-level deficiency to the program, CMS must 
receive notification of the program's intent to seek mitigating factors 
approval, and receive all information for consideration of mitigating 
factors within 120 calendar days of the CMS written notification for a 
deficiency due to data

[[Page 293]]

submission, clinical experience or outcomes at Sec. 482.80 of this 
chapter. Failure to meet these timeframes may be the basis for denial of 
mitigating factors. CMS may permit an extension of the timeline for good 
cause, such as a declared public health emergency.
    (f) Results of mitigating factors review--(1) Actions. Upon review 
of the request to consider mitigating factors, CMS may take the 
following actions:
    (i) Approve initial approval of a program's Medicare participation 
based upon approval of mitigating factors.
    (ii) Deny the program's request for Medicare approval based on 
mitigating factors.
    (iii) Offer a time-limited Systems Improvement Agreement, in 
accordance with paragraph (g) of this section, when a transplant program 
has waived its appeal rights, has implemented substantial program 
improvements that address root causes and are institutionally supported 
by the hospital's governing body on a sustainable basis, and has 
requested more time to design or implement additional improvements or 
demonstrate compliance with CMS outcome requirements. Upon completion of 
the Systems Improvement Agreement or a CMS finding that the hospital has 
failed to meet the terms of the Agreement, CMS makes a final 
determination of whether to approve or deny a program's request for 
Medicare approval based on mitigating factors. A Systems Improvement 
Agreement follows the process specified in paragraph (g) of this 
section.
    (2) Limitation. CMS will not approve any program with a condition-
level deficiency. However, CMS may approve a program with a standard-
level deficiency upon receipt of an acceptable plan of correction.
    (g) Transplant Systems Improvement Agreement. A Systems Improvement 
Agreement is a binding agreement, entered into voluntarily by the 
hospital and CMS, through which CMS extends a prospective Medicare 
termination date and offers the program additional time to achieve 
compliance with the conditions of participation, contingent on the 
hospital's agreement to participate in a structured regimen of quality 
improvement activities, demonstrate improved outcomes, and waive the 
right to appeal termination based on the identified deficiency or 
deficiencies (that led to the Agreement) in consideration for more time 
to demonstrate compliance. In some cases, transplant programs may enter 
a period of inactivity--voluntarily, or imposed as a condition of the 
Systems Improvement Agreement.
    (1) Content. In exchange for the additional time to initiate or 
continue activities to achieve compliance with the conditions of 
participation, the hospital must agree to a regimen of specified 
activities, including (but not limited to) all of the following:
    (i) Patient notification about the degree and type of noncompliance 
by the program, an explanation of what the program improvement efforts 
mean for patients, and financial assistance to defray the out-of-pocket 
costs of copayments and testing expenses for any wait-listed individual 
who wishes to be listed with another program;
    (ii) An external independent peer review team that conducts an 
onsite assessment of the program. The peer review must include--
    (A) Review of policies, staffing, operations, relationship to 
hospital services, and factors that contribute to program outcomes;
    (B) Suggestions for quality improvements the hospital should 
consider;
    (C) Both verbal and written feedback provided directly to the 
hospital;
    (D) Verbal debriefing provided directly to CMS; neither the hospital 
nor the peer review team is required to provide a written report to CMS; 
and
    (E) Onsite review by a multidisciplinary team that includes a 
transplant surgeon with expertise in the relevant organ type(s), a 
transplant administrator, an individual with expertise in transplant 
QAPI systems, a social worker or psychologist or psychiatrist, and a 
specialty physician with expertise in conditions particularly relevant 
to the applicable organ types(s) such as a cardiologist, nephrologist, 
or hepatologist. Except for the transplant surgeon, CMS may permit 
substitution of one type of expertise for another individual who has 
expertise particularly needed for the type of challenges experienced by 
the

[[Page 294]]

program, such as substitution of an infection control specialist in lieu 
of, or in addition to, a social worker;
    (iii) An action plan that addresses systemic quality improvements 
and is updated after the onsite peer review;
    (iv) An onsite consultant whose qualifications are approved by CMS, 
and who provides services for 8 days per month on average for the 
duration of the agreement, except that CMS may permit a portion of the 
time to be spent offsite and may agree to fewer consultant days each 
month after the first 3 months of the Systems Improvement Agreement;
    (v) A comparative effectiveness analysis that compares policies, 
procedures, and protocols of the transplant program with those of other 
programs in areas of endeavor that are relevant to the center's current 
quality improvement needs;
    (vi) Development of increased proficiency, or demonstration of 
current proficiency, with patient-level data from the Scientific 
Registry of Transplant Recipients and the use of registry data to 
analyze outcomes and inform quality improvement efforts;
    (vii) A staffing analysis that examines the level, type, training, 
and skill of staff in order to inform transplant center efforts to 
ensure the engagement and appropriate training and credentialing of 
staff;
    (viii) Activities to strengthen performance of the Quality 
Assessment and Performance Improvement Program to ensure full compliance 
with the requirements of Sec. 482.96 and Sec. 482.21 of this chapter;
    (ix) Monthly (unless otherwise specified) reporting and conference 
calls with CMS regarding the status of programmatic improvements, 
results of the deliverables in the Systems Improvement Agreement, and 
the number of transplants, deaths, and graft failures that occur within 
1 year post-transplant; and
    (x) Additional or alternative requirements specified by CMS, 
tailored to the transplant program type and circumstances. CMS may waive 
the content elements at paragraph (g)(1)(v), (vi), (vii) or (viii) of 
this section if it finds that the program has already adequately 
conducted the activity, the program is already proficient in the 
function, or the activity is clearly inapplicable to the deficiencies 
that led to the Agreement.
    (2) Timeframe. A Systems Improvement Agreement will be established 
for up to a 12-month period, subject to CMS' discretion to determine if 
a shorter timeframe may suffice. At the hospital's request, CMS may 
extend the agreement for up to an additional 6-month period. A signed 
Systems Improvement Agreement remains in force even if a subsequent SRTR 
report indicates that the program has restored compliance with the CMS 
conditions of participation, except that CMS in its sole discretion may 
shorten the timeframe or allow modification to any portion of the 
elements of the Agreement in such a case.

[72 FR 15278, Mar. 30, 2007, as amended at 79 FR 27156, May 12, 2014; 79 
FR 50359, Aug. 22, 2014; 81 FR 79881, Nov. 14, 2016; 84 FR 51831, Sept. 
30, 2019]



Sec. 488.64  Remote facility variances for utilization review 
requirements.

    (a) As used in this section:
    (1) An ``available'' individual is one who:
    (i) Possesses the necessary professional qualifications;
    (ii) Is not precluded from participating by reason of financial 
interest in any such facility or direct responsibility for the care of 
the patients being reviewed or, in the case of a skilled nursing 
facility, employment by the facility; and
    (iii) Is not precluded from effective participation by the distance 
between the facility and his residence, office, or other place of work. 
An individual whose residence, office, or other place of work is more 
than approximately one hour's travel time from the facility shall be 
considered precluded from effective participation.
    (2) ``Adjacent facility'' means a health care facility located 
within a 50-mile radius of the facility which requests a variance.
    (b) The Secretary may grant a requesting facility a variance from 
the time frames set forth in Sec. Sec. 405.1137(d) of this chapter and 
482.30 as applicable, within which reviews all of cases must be 
commenced and completed, upon a

[[Page 295]]

showing satisfactory to the Secretary that the requesting facility has 
been unable to meet one or more of the requirements of Sec. 405.1137 of 
this chapter or Sec. 482.30 of this chapter, as applicable, by reason 
of insufficient medical and other professional personnel available to 
conduct the utilization review required by Sec. 405.1137 of this 
chapter or Sec. 482.30 of this chapter, as applicable.
    (c) The request for variance shall document the requesting 
facility's inability to meet the requirements for which a variance is 
requested and the facility's good faith efforts to comply with the 
requirements contained in Sec. 405.1137 of this chapter or Sec. 482.30 
of this chapter, as applicable.
    (d) The request shall include an assurance by the requesting 
facility that it will continue its good faith efforts to meet the 
requirements contained in Sec. 405.1137 of this chapter or Sec. 482.30 
of this chapter, as applicable.
    (e) A revised utilization review plan for the requesting facility 
shall be submitted concurrently with the request for a variance. The 
revised plan shall specify the methods and procedures which the 
requesting facility will use, if a variance is granted, to assure:
    (1) That effective and timely control will be maintained over the 
utilization of services; and
    (2) That reviews will be conducted so as to improve the quality of 
care provided to patients.
    (f) The request for a variance shall include:
    (1) The name, location, and type (e.g., hospital, skilled nursing 
facility) of the facility for which the variance is requested;
    (2) The total number of patient admissions and average daily patient 
census at the facility within the previous six months;
    (3) The total number of title XVIII and title XIX patient admissions 
and the average daily patient census of title XVIII and title XIX 
patients in the facility within the previous six months;
    (4) As relevant to the request, the names of all physicians on the 
active staff of the facility and the names of all other professional 
personnel on the staff of the facility, or both;
    (5) The name, location, and type of each adjacent facility (e.g., 
hospital, skilled nursing facility);
    (6) The distance and average travel time between the facility and 
each adjacent facility;
    (7) As relevant to the request, the location of practice of 
available physicians and the estimated number of other available 
professional personnel, or both (see paragraph (a)(1)(iii) of this 
section);
    (8) Documentation by the facility of its attempt to obtain the 
services of available physicians or other professional personnel, or 
both; and
    (9) A statement of whether a QIO exists in the area where the 
facility is located.
    (g) The Secretary shall promptly notify the facility of the action 
taken on the request. Where a variance is in effect, the validation of 
utilization review pursuant to Sec. 405.1137 of this chapter or Sec. 
482.30 shall be made with reference to the revised utilization review 
plan submitted with the request for variance.
    (h) The Secretary, in granting a variance, will specify the period 
for which the variance has been granted; such period will not exceed one 
year. A request for a renewal shall be submitted not later than 30 days 
prior to the expiration of the variance and shall contain all 
information required by paragraphs (c), (d), and (f) of this section. 
Renewal of the variance will be contingent upon the facility's 
continuing to meet the provisions of this section.

[40 FR 30818, July 23, 1975. Redesignated at 42 FR 52826, Sept. 30, 
1977; 51 FR 22041, June 17, 1986; 51 FR 27847, Aug. 4, 1986; 51 FR 
43197, Dec. 1, 1986. Redesignated and amended at 53 FR 23100, June 17, 
1988]



Sec. 488.68  State Agency responsibilities for OASIS collection
and data base requirements.

    As part of State agency survey responsibilities, the State agency or 
other entity designated by CMS has overall responsibility for fulfilling 
the following requirements for operating the OASIS system:
    (a) Establish and maintain an OASIS database. The State agency or 
other entity designated by CMS must--

[[Page 296]]

    (1) Use a standard system developed or approved by CMS to collect, 
store, and analyze data;
    (2) Conduct basic system management activities including hardware 
and software maintenance, system back-up, and monitoring the status of 
the database; and
    (3) Obtain CMS approval before modifying any parts of the CMS 
standard system including, but not limited to, standard CMS-approved--
    (i) OASIS data items;
    (ii) Record formats and validation edits; and
    (iii) Agency encoding and transmission methods.
    (b) Analyze and edit OASIS data. The State agency or other entity 
designated by CMS must--
    (1) Upon receipt of data from an HHA, edit the data as specified by 
CMS and ensure that the HHA resolves errors within the limits specified 
by CMS;
    (2) At least monthly, make available for retrieval by CMS all edited 
OASIS records received during that period, according to formats 
specified by CMS, and correct and retransmit previously rejected data as 
needed; and
    (3) Analyze data and generate reports as specified by CMS.
    (c) Ensure accuracy of OASIS data. The State agency must audit the 
accuracy of the OASIS data through the survey process.
    (d) Restrict access to OASIS data. The State agency or other entity 
designated by CMS must do the following:
    (1) Ensure that access to data is restricted except for the 
transmission of data and reports to--
    (i) CMS;
    (ii) The State agency component that conducts surveys for purposes 
related to this function; and
    (iii) Other entities if authorized by CMS.
    (2) Ensure that patient identifiable OASIS data is released only to 
the extent that it is permitted under the Privacy Act of 1974.
    (e) Provide training and technical support for HHAs. The State 
agency or other entity designated by CMS must--
    (1) Instruct each HHA on the administration of the data set, 
privacy/confidentiality of the data set, and integration of the OASIS 
data set into the facility's own record keeping system;
    (2) Instruct each HHA on the use of software to encode and transmit 
OASIS data to the State;
    (3) Specify to a facility the method of transmission of data to the 
State, and instruct the facility on this method.
    (4) Monitor each HHA's ability to transmit OASIS data.
    (5) Provide ongoing technical assistance and general support to HHAs 
in implementing the OASIS reporting requirements specified in the 
conditions of participation for home health agencies; and
    (6) Carry out any other functions as designated by CMS necessary to 
maintain OASIS data on the standard State system.

[64 FR 3763, Jan. 25, 1999]



                  Subpart C_Survey Forms and Procedures

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Sec. 488.100  Long term care survey forms, Part A.
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Sec. 488.105  Long term care survey forms, Part B.
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Sec. 488.110  Procedural guidelines.

    SNF/ICF Survey Process. The purpose for implementing a new SNF/ICF 
survey process is to assess whether the quality of care, as intended by 
the law and regulations, and as needed by the resident, is actually 
being provided in nursing homes. Although the onsite review procedures 
have been changed, facilities must continue to meet all applicable 
Conditions/Standards, in order to participate in Medicare/Medicaid 
programs. That is, the methods used to

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compile information about compliance with law and regulations are 
changed; the law and regulations themselves are not changed. The new 
process differs from the traditional process, principally in terms of 
its emphasis on resident outcomes. In ascertaining whether residents 
grooming and personal hygiene needs are met, for example, surveyors will 
no longer routinely evaluate a facility's written policies and 
procedures. Instead, surveyors will observe residents in order to make 
that determination. In addition, surveyors will confirm, through 
interviews with residents and staff, that such needs are indeed met on a 
regular basis. In most reviews, then, surveyors will ascertain whether 
the facility is actually providing the required and needed care and 
services, rather than whether the facility is capable of providing the 
care and services.

 The Outcome-Oriented Survey Process--Skilled Nursing Facilities (SNFs) 
                 and Intermediate Care Facilities (ICFs)

    (a) General.
    (b) The Survey Tasks.
    (c) Task 1--Entrance Conference.
    (d) Task 2--Resident Sample--Selection Methodology.
    (e) Task 3--Tour of the Facility.
    (f) Task 4--Observation/Interview/Medical Record Review (including 
drug regimen review).
    (g) Task 5--Drug Pass Observation.
    (h) Task 6--Dining Area and Eating Assistance Observation.
    (i) Task 7--Forming the Deficiency Statement.
    (j) Task 8--Exit Conference.
    (k) Plan of Correction.
    (l) Followup Surveys.
    (m) Role of Surveyor.
    (n) Confidentiality and Respect for Resident Privacy.
    (o) Team Composition.
    (p) Type of Facility-Application of SNF or ICF Regulations.
    (q) Use of Part A and Part B of the Survey Report.

    (a) General. A complete SNF/ICF facility survey consists of three 
components:
     Life Safety Code requirements;
     Administrative and structural requirements (Part 
A of the Survey Report, Form CMS-525); and
     Direct resident care requirements (Part B of the 
Survey Report, Form CMS-519), along with the related worksheets (CMS-520 
through 524).
    Use this survey process for all surveys of SNFs and ICFs--whether 
freestanding, distinct parts, or dually certified. Do not use this 
process for surveys of Intermediate Care Facilities for Mentally 
Retarded (ICFs/IID), swing-bed hospitals or skilled nursing sections of 
hospitals that are not separately certified as SNF distinct parts. Do 
not announce SNF/ICF surveys ahead of time.
    (b) The Survey Tasks. Listed below are the survey tasks for easy 
reference:
     Task 1. Entrance Conference.
     Task 2. Resident Sample--Selection Methodology.
     Task 3. Tour of the Facility. Resident Needs. 
Physical Environment. Meeting with Resident Council Representatives. 
Tour Summation and Focus of Remaining Survey Activity.
     Task 4. Observation/Interview/Medical Record. 
Review of Each Individual in the Resident Sample (including drug regimen 
review).
     Task 5. Drug Pass Observation.
     Task 6. Dining Area and Eating Assistance 
Observation.
     Task 7. Forming the Deficiency Statement (if 
necessary).
     Task 8. Exit Conference.
    (c) Task 1--Entrance Conference. Perform these activities during the 
entrance conference in every certification and recertification survey:
     Introduce all members of the team to the facility 
staff, if possible, even though the whole team may not be present for 
the entire entrance conference. (All surveyors wear identification 
tags.)
     Explain the SNF/ICF survey process as resident 
centered in focus, and outline the basic steps.
     Ask the facility for a list showing names of 
residents by room number with each of the following care needs/
treatments identified for each resident to whom they apply:

--Decubitus care
--Restraints
--Catheters
--Injections
--Parenteral fluids
--Rehabilitation service
--Colostomy/ileostomy care
--Respiratory care

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--Tracheostomy care
--Suctioning
--Tube feeding

    Use this list for selecting the resident sample.
     Ask the facility to complete page 2 of Form CMS-
519 (Resident Census) as soon as possible, so that the information can 
further orient you to the facility's population. In a survey of a SNF 
with a distinct part ICF, you may collect two sets of census data. 
However, consolidate the information when submitting it to the regional 
office. You may modify the Resident Census Form to include the numbers 
of licensed and certified beds, if necessary.
     Ask the facility to post signs on readily viewed 
areas (at least one on each floor) announcing that State surveyors are 
in the facility performing an ``inspection,'' and are available to meet 
with residents in private. Also indicate the name and telephone number 
of the State agency. Hand-printed signs with legible, large letters are 
acceptable.
     If the facility has a Resident Council, make 
mutually agreeable arrangements to meet privately with the president and 
officers and other individuals they might invite.
     Inform the facility that interviews with 
residents and Resident Councils are conducted privately, unless they 
independently request otherwise, in order to enhance the development of 
rapport as well as to allay any resident anxiety. Tell the facility that 
information is gathered from interviews, the tour, observations, 
discussions, record review, and facility officials. Point out that the 
facility will be given an opportunity to respond to all findings.
    (d) Task 2--Resident Sample--Selection Methodology. This methodology 
is aimed at formulating a sample that reflects the actual distribution 
of care needs/treatments in the facility population.
    Primarily performed on a random basis, it also ensures 
representation in the sample of certain care needs and treatments that 
are assessed during the survey.
    (1) Sample Size. Calculate the size of the sample according to the 
following guide:

------------------------------------------------------------------------
                                          Number of residents in sample
    Number of residents in facility                    \1\
------------------------------------------------------------------------
0-60 residents.........................  25% of residents (minimum--10).
61-120 residents.......................  20% of residents (minimum--15).
121-200 residents......................  15% of residents (minimum--24).
201 + residents........................  10% of residents (minimum--30).
 
------------------------------------------------------------------------
\1\ Maximum--50.

    Note that the calculation is based on the resident census, not beds. 
After determining the appropriate sample size, select residents for the 
sample in a random manner. You may, for example, select every fifth 
resident from the resident census, beginning at a random position on the 
list. For surveys of dually certified facilities or distinct part SNFs/
ICFs, first use the combined SNF/ICF population to calculate the size of 
the sample, and then select a sample that reflects the proportions of 
SNF and ICF residents in the facility's overall population.
    (2) Special Care Needs/Treatments. The survey form specifies several 
care needs/treatments that must always be reviewed when they apply to 
any facility residents. These include:

 Decubitus Care
 Restraints
 Catheters
 Injections, Parenteral Fluids, Colostomy/Ileostomy, 
    Respiratory Care, Tracheostomy Care, Suctioning, Tube Feeding
 Rehabilitative Services (physical therapy, speech 
    pathology and audiology services, occupational therapy)

    Due to the relatively low prevalence of these care needs/treatments, 
appropriate residents may be either under-

represented or entirely omitted from the sample. Therefore, determine 
during the tour how many residents in the random selection fall into 
each of these care categories. Then, compare the number of such 
residents in the random selection with the total number of residents in 
the facility with each specified care need/treatment (based on either 
the resident census or other information provided by the facility).
    Review no less than 25 percent of the residents in each of these 
special care needs/treatments categories. For example, if the facility 
has 10 residents with

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decubitus ulcers, but only one of these residents is selected randomly, 
review two more residents with decubitis ulcers (25% of 10 equals 2.5, 
so review a total of 3). Or, if the facility has two residents who 
require tube feeding, neither of whom is in the random selection, review 
the care of at least one of the these residents. This can be 
accomplished in the following manner:
    Conduct in-depth reviews of the randomly selected residents and then 
perform limited reviews of additional residents as needed to cover the 
specified care categories. Such reviews are limited to the care and 
services related to the pertinent care areas only, e.g., catheters, 
restraints, or colostomy. Utilize those worksheets or portions of 
worksheets which are appropriate to the limited review. Refer to the 
Care Guidelines, as a resource document, when appropriate.
    Always keep in mind that neither the random selection approach nor 
the review of residents within the specified care categories precludes 
investigation of other resident care situations that you believe might 
pose a serious threat to a resident's health or safety. Add to the 
sample, as appropriate.
    (e) Task 3--Tour of the Facility--(1) Purpose. Conduct the tour in 
order to:
     Develop an overall picture of the types and 
patterns of care delivery present within the facility;
     View the physical environment; and
     Ascertain whether randomly selected residents are 
communicative and willing to be interviewed.
    (2) Protocol. You may tour the entire facility as a team or 
separately, as long as all areas of the facility are examined by at 
least one team member. Success of the latter approach, however, is 
largely dependent on open intra-team communication and the ability of 
each team member to identify situations for further review by the team 
member of the appropriate discipline. You may conduct the tour with or 
without facility staff accompanying you, as you prefer. Facilities, 
however, vary in staff member availability. Record your notes on the 
Tour Notes Worksheet, Form CMS-521.
    Allow approximately three hours for the tour. Converse with 
residents, family members/significant others (if present), and staff, 
asking open-ended questions in order to confirm observations, obtain 
additional information, or corroborate information, (e.g., accidents, 
odors, apparent inappropriate dress, adequacy and appropriateness of 
activities). Converse sufficiently with residents selected for in-depth 
review to ascertain whether they are willing to be interviewed and are 
communicative. Observe staff interactions with other staff members as 
well as with residents for insight into matters such as resident rights 
and assignments of staff responsibilities.
    Always knock and/or get permission before entering a room or 
interrupting privacy. If you wish to inspect a resident's skin, observe 
a treatment procedure, or observe a resident who is exposed, courteously 
ask permission from the resident if she/he comprehends, or ask 
permission from the staff nurse if the resident cannot communicate. Do 
not do ``hands-on'' monitoring such as removal of dressings; ask staff 
to remove a dressing or handle a resident.
    (3) Resident Needs. While touring, focus on the residents' needs--
physical, emotional, psychosocial, or spiritual--and whether those needs 
are being met. Refer to the following list as needed:

--Personal hygiene, grooming, and appropriate dress
--Position
--Assistive and other restorative devices
--Rehabilitation issues
--Functional limitations in ADL
--Functional limitations in gait, balance and coordination
--Hydration and nutritional status
--Resident rights
--Activity for time of day (appropriate or inappropriate)
--Emotional status
--Level of orientation
--Awareness of surroundings
--Behaviors
--Cleanliness of immediate environment (wheelchair, bed, bedside table, 
    etc.)
--Odors
--Adequate clothing and care supplies as well as maintenance and 
    cleanliness of same

    (4) Review of the Physical Environment. As you tour each resident's 
room and

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auxiliary rooms, also examine them in connection with the physical 
environment requirements. You need not document physical environment on 
the Tour Notes Worksheet. Instead, you may note any negative findings 
directly on the Survey Report Form in the remarks section.
    (5) Meeting With Resident Council Representatives. If a facility has 
a Resident Council, one or more surveyors meet with the respresentatives 
in a private area. Facility staff members do not attend unless 
specifically requested by the Council. Explain the purpose of the survey 
and briefly outline the steps in the survey process, i.e., entrance 
conference * * * exit conference. Indicate your interest in learning 
about the strengths of the facility in addition to any complaints or 
shortcomings. State that this meeting is one part of the information 
gathering; the findings have not yet been completed nor the conclusions 
formulated. Explain further, however, that the official survey findings 
are usually available within three months after the completion of the 
survey, and give the telephone number of the State agency office.
    Use this meeting to ascertain strengths and/or problems, if any, 
from the consumer's perspective, as well as to develop additional 
information about aspects of care and services gleaned during the tour 
that were possibly substandard.
    Conduct the meeting in a manner that allows for comments about any 
aspect of the facility. (See the section on Interview Procedures.) Use 
open-ended questions such as:

     ``What is best about this home?''
     ``What is worst?''
     ``What would you like to change?''

    In order to get more detail, use questions such as:

     ``Can you be more specific?''
     ``Can you give me an example?''
     ``What can anyone else tell me about this?''

    If you wish to obtain information about a topic not raised by the 
residents, use an approach like the following:

     ``Tell me what you think about the food/staff/
cleanliness here.''
     ``What would make it better?''
     ``What don't you like? What do you like?''

    (6) Tour Summation and Focus of Remaining Survey Activity. When the 
tour is completed, review the resident census data provided by the 
facility. Determine if the care categories specified in the section on 
Resident Sample are sufficiently represented in the random selection, 
make adjustments as needed, and complete the listing of residents on the 
worksheet labeled ``Residents Selected for In-depth Review'', Form CMS-
520.
    Transcribe notes of a negative nature onto the SRF in the 
``Remarks'' column under the appropriate rule. Findings from a later 
segment in the survey or gathered by another surveyor may combine to 
substantiate a deficiency. You need not check ``met'' or ``not met'' at 
this point in the survey. Discuss significant impressions/conclusions at 
the completion of each subsequent survey task, and transfer any negative 
findings onto the Survey Report Form in the Remarks section.
    (f) Task 4--Observation/Interview/Medical Record Review (including 
drug regimen review). Perform the in-depth review of each individual in 
the resident sample in order to ascertain whether the facility is 
meeting resident needs. Evaluate specific indicators for each resident, 
utilizing the front and back of the ``Observation/Interview/Record 
Review (OIRR)'' worksheet, Form CMS-524. You may prefer to perform the 
record review first, complete resident/staff/family observations and 
interviews, and finally, return to the record for any final unresolved 
issues. On the other hand, you may prefer to do the interviews first. 
Either method is acceptable. Whenever possible, however, complete one 
resident's observation/interview/medical record review and document the 
OIRR before moving onto another resident. If because of the facility 
layout, it is more efficient to do more than one record review at a 
time, limit such record review to two or three residents so your 
familiarity with the particular resident and continuity of the OIRR are 
not compromised.
    (1) Observation. Conduct observations concurrently with interviews 
of residents, family/significant others, and

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discussions with direct care staff [of the various disciplines involved. 
In multi-facility operations, whenever possible, observe staff that is 
regularly assigned to the facility in order to gain an understanding of 
the care and services usually provided.] Maintain respect for resident 
privacy. Minimize disruption of the operations of the facility or 
impositions upon any resident as much as possible. Based upon your 
observations of the residents' needs, gather information about any of 
the following areas, as appropriate:

Bowel and bladder training
Catheter care
Restraints
Injections
Parenteral fluids
Tube feeding/gastrostomy
Colostomy/ileostomy
Respiratory therapy
Tracheostomy care
Suctioning

    (2) Interviews. Interview each resident in private unless he/she 
independently requests that a facility staff member or other individual 
be present. Conduct the in-depth interview in a nonthreatening and 
noninvasive fashion so as to decrease anxiety and defensiveness. The 
open-ended approach described in the section on the Resident Council is 
also appropriate for the in-depth interview. While prolonged time 
expenditure is not usually a worthwhile use of resources or the 
resident's time, do allow time initially to establish rapport.
    At each interview:

     Introduce yourself.
     Address the resident by name.
     Explain in simple terms the reason for your visit 
(e.g., to assure that the care and services are adequate and appropriate 
for each resident).
     Briefly outline the process--entrance conference, 
tour, interviews, observations, review of medical records, resident 
interviews, and exit conference.
     Mention that the selection of a particular 
resident for an interview is not meant to imply that his/her care is 
substandard or that the facility provides substandard care. Also mention 
that most of those interviewed are selected randomly.
     Assure that you will strive for anonymity for the 
resident and that the interview is used in addition to medical records, 
observations, discussions, etc., to capture an accurate picture of the 
treatment and care provided by the facility. Explain that the official 
findings of the survey are usually available to the public about three 
months after completion of the survey, but resident names are not given 
to the public.
     When residents experience difficulty expressing 
themselves:

--Avoid pressuring residents to verbalize
--Accept and respond to all communication
--Ignore mistakes in word choice
--Allow time for recollection of words
--Encourage self-expression through any means available

     When interviewing residents with decreased 
receptive capacity:

--Speak slowly and distinctly
--Speak at conversational voice level
--Sit within the resident's line of vision
 Listen to all resident information/allegations 
    without judgment. Information gathered subsequently may substantiate 
    or repudiate an allegation.

    The length of the interview varies, depending on the condition and 
wishes of the resident and the amount of information supplied. Expect 
the average interview, however, to last approximately 15 minutes. 
Courteously terminate an interview whenever the resident is unable or 
unwilling to continue, or is too confused or disoriented to continue. 
Do, however, perform the other activities of this task (observation and 
record review). If, in spite of your conversing during the tour, you 
find that less than 40 percent of the residents in your sample are 
sufficiently alert and willing to be interviewed, try to select 
replacements so that a complete OIRR is performed for a group this size, 
if possible. There may be situations, however, where the resident 
population has a high percentage of confused individuals and this 
percentage is not achievable. Expect that the information from confused 
individuals can be, but is not necessarily, less

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reliable than that from more alert individuals.
    Include the following areas in the interview of each resident in the 
sample:

Activities of daily living
Grooming/hygiene
Nutrition/dietary
Restorative/rehabilitation care and services
Activities
Social services
Resident rights

    Refer to the Care Guidelines ``evaluation factors'' as a resource 
for possible elements to consider when focusing on particular aspects of 
care and resident needs.
    Document information obtained from the interviews/observations on 
the OIRR Worksheet. Record in the ``Notes'' section any additional 
information you may need in connection with substandard care or 
services. Unless the resident specifically requests that he/she be 
identified, do not reveal the source of the information gleaned from the 
interview.
    (3) Medical Record Review. The medical record review is a three-part 
process, which involves first reconciling the observation/interview 
findings with the record, then reconciling the record against itself, 
and lastly performing the drug regimen review.
    Document your findings on the OIRR Worksheet, as appropriate, and 
summarize on the Survey Report Form the findings that are indicative of 
problematic or substandard care. Be alert for repeated similar instances 
of substandard care developing as the number of completed OIRR 
Worksheets increases.

    Note: The problems related to a particular standard or condition 
could range from identical (e.g., meals not in accordance with dietary 
plan) to different but related (e.g., nursing services--lapse in care 
provided to residents with catheters, to residents with contractures, to 
residents needing assistance for personal hygiene and residents with 
improperly applied restraints).

    (i) Reconciling the observation/interview findings with the record. 
Determine if:

     An assessment has been performed.
     A plan with goals has been developed.
     The interventions have been carried out.
     The resident has been evaluated to determine the 
effectiveness of the interventions.

    For example, if a resident has developed a decubitus ulcer while in 
the facility, record review can validate staff and resident interviews 
regarding the facility's attempts at prevention. Use your own judgment; 
review as much of the record(s) as necessary to evaluate the care 
planning. Note that facilities need not establish specific areas in the 
record stating ``Assessment,'' ``Plan,'' ``Intervention,'' or 
``Evaluation'' in order for the documentation to be considered adequate.
    (ii) Reconciling the record with itself. Determine:

     If the resident has been properly assessed for 
all his/her needs.
     That normal and routine nursing practices such as 
periodic weights, temperatures, blood pressures, etc., are performed as 
required by the resident's conditions.

    (iii) Performing the drug regimen review. The purpose of the drug 
regimen review is to determine if the pharmacist has reviewed the drug 
regimen on a monthly basis. Follow the procedures in Part One of 
Appendix N, Surveyor Procedures for Pharmaceutical Service Requirements 
in Long-Term Care Facilities. Fill in the appropriate boxes on the top 
left hand corner of the reverse side of the OIRR Worksheet, Form CMS-
524. Appendix N lists many irregularities that can occur. Review at 
least six different indicators on each survey. However, the same six 
indicators need not be reviewed on every survey.

    Note: If you detect irregularities and the documentation 
demonstrates that the pharmacist has notified the attending physician, 
do not cite a deficiency. Do, however, bring the irregularity to the 
attention of the medical director or other facility official, and note 
the official's name and date of notification on the Survey Report Form.
    (g) Task 5--Drug Pass Observation. The purpose of the drug pass 
observation is to observe the actual preparation and administration of 
medications to residents. With this approach, there is no doubt that the 
errors detected, if any, are errors in drug administration, not

[[Page 397]]

documentation. Follow the procedure in Part Two of Appendix N, Surveyor 
Procedures for Pharmaceutical Service Requirements in Long-Term Care 
Facilities, and complete the Drug Pass Worksheet, Form CMS-522. Be as 
neutral and unobtrusive as possible during the drug pass observation. 
Whenever possible, select one surveyor, who is a Registered Nurse or a 
pharmacist, to observe the drug pass of approximately 20 residents. In 
facilities where fewer than 20 residents are receiving medications, 
review as many residents receiving medications as possible. Residents 
selected for the in-depth review need not be included in the group 
chosen for the drug pass; however, their whole or partial inclusion is 
acceptable. In order to get a balanced view of a facility's practices, 
observe more than one person administering a drug pass, if feasible. 
This might involve observing the morning pass one day in Wing A, for 
example, and the morning pass the next day in Wing B.
    Transfer findings noted on the ``Drug Pass'' worksheet to the SRF 
under the appropriate rule. If your team concludes that the facility's 
medication error rate is 5 percent or more, cite the deficiency under 
Nursing Services/Administration of Drugs. Report the error rate under 
F209. If the deficiency is at the standard level, cite it in Nursing 
Services, rather than Pharmacy.
    (h) Task 6--Dining Area and Eating Assistance Observation. The 
purpose of this task is to ascertain the extent to which the facility 
meets dietary needs, particularly for those who require eating 
assistance. This task also yields information about staff interaction 
with residents, promptness and appropriateness of assistance, adaptive 
equipment usage and availability, as well as appropriateness of dress 
and hygiene for meals.
    For this task, use the worksheet entitled ``Dining Area and Eating 
Assistance Observation'' (Form CMS-523). Observe two meals; for a 
balanced view, try to observe meals at different times of the day. For 
example, try to observe a breakfast and a dinner rather than two 
breakfasts. Give particular care to performing observations as 
unobtrusively as possible. Chatting with residents and sitting down 
nearby may help alleviate resident anxiety over the observation process.
    Select a minimum of five residents for each meal observation and 
include residents who have their meals in their rooms. Residents 
selected for the in-depth review need not be included in the dining and 
eating assistance observation; however, their whole or partial inclusion 
is acceptable. Ascertain the extent to which the facility assesses, 
plans, and evaluates the nutritional care of residents and eating 
assistance needs by reviewing the sample of 10 or more residents. If you 
are unable to determine whether the facility meets the standards from 
the sample reviewed, expand the sample and focus on the specific area(s) 
in question, until you can formulate a conclusion about the extent of 
compliance. As with the other survey tasks, transfer the findings noted 
on the ``Dining & Eating Assistance Observation'' worksheet to the 
Survey Report Form.
    (i) Task 7--Forming the Deficiency Statement--(1) General. The 
Survey Report Form contains information about all of the negative 
findings of the survey. Be sure to transfer to the Survey Report Form 
data from the tour, drug pass observation, dining area and eating 
assistance observation, as well as in-depth review of the sample of 
residents. Transfer only those findings which could possibly contribute 
to a determination that the facility is deficient in a certain area.
    Meet as a group in a pre-exit conference to discuss the findings and 
make conclusions about the deficiencies, subject to information provided 
by facility officials that may further explain the situation. Review the 
summaries/conclusions from each task and decide whether any further 
information and/or documentation is necessary to substantiate a 
deficiency. As the facility for additional information for clarification 
about particular findings, if necessary. Always consider information 
provided by the facility. If the facility considers as acceptable, 
practices which you believe are not acceptable, ask the facility to 
backup its contention with suitable reference material or sources and 
submit them for your consideration.

[[Page 398]]

    (2) Analysis. Analyze the findings on the Survey Report Form for the 
degree of severity, frequency of occurrence and impact on delivery of 
care or quality of life. The threshold at which the frequency of 
occurrences amounts to a deficiency varies from situation to situation. 
One occurrence directly related to a life-threatening or fatal outcome 
can be cited as a deficiency. On the other hand, a few sporadic 
occurrences may have so slight an impact on delivery of care or quality 
of life that they do not warrant a deficiency citation. Review carefully 
all the information gathered. What may appear during observation as a 
pattern, may or may not be corroborated by records, staff, and 
residents. For example, six of the 32 residents in the sample are 
dressed in mismatched, poorly buttoned clothes. A few of the six are 
wearing slippers without socks. A few others are wearing worn clothes. 
Six occurrences might well be indicative of a pattern of susbstandard 
care. Close scrutiny of records, discussions with staff, and interviews 
reveal, however, that the six residents are participating in dressing 
retraining programs. Those residents who are without socks, chose to do 
so. The worn clothing items were also chosen--they are favorites.
    Combinations of substandard care such as poor grooming of a number 
of residents, lack of ambulation of a number of residents, lack of 
attention to positioning, poor skin care, etc., can yield a deficiency 
in nursing services just as 10 out of 10 residents receiving substandard 
care for decubiti yields a deficiency.
    (3) Deficiencies Alleged by Staff or Residents. If staff or 
residents allege deficiencies, but records, interviews, and observation 
fail to confirm the situation, it is unlikely that a deficiency exists. 
Care and services that are indeed confirmed by the survey to be in 
compliance with the regulatory requirements, but considered deficient by 
residents or staff, cannot be cited as deficient for certification 
purposes. On the other hand, if an allegation is of a very serious 
nature (e.g., resident abuse) and the tools of record review and 
observation are not effective because the problem is concealed, obtain 
as much information as possible or necessary to ascertain compliance, 
and cite accordingly. Residents, family, or former employees may be 
helpful for information gathering.
    (4) Composing the Deficiency Statement. Write the deficiency 
statement in terms specific enough to allow a reasonably knowledgeable 
person to understand the aspect(s) of the requirement(s) that is (are) 
not met. Do not delve into the facility's policies and procedures to 
determine or speculate on the root cause of a deficiency, or sift 
through various alternatives in an effort to prescribe an acceptable 
remedy. Indicate the data prefix tag and regulatory citation, followed 
by a summary of the deficiency and supporting findings using resident 
identifiers, not resident names, as in the following example.

    F102 SNF 405.1123(b).--Each resident has not had a physician's visit 
at least once every 30 days for the first 90 days after admission. 
Resident 1602 has not been seen by a physician since she was admitted 
50 days ago. Her condition has deteriorated since that time (formulation 
of decubiti, infections).

    When the data prefix tag does not repeat the regulations, also 
include a short phrase that describes the prefix tag (e.g., F117 
decubitus ulcer care). List the data tags in numerical order, whenever 
possible.
    (j) Task 8--Exit Conference. The purpose of the exit conference is 
to inform the facility of survey findings and to arrange for a plan of 
correction, if needed. Keep the tone of the exit conference consistent 
with the character of the survey process--inspection and enforcement. 
Tactful, business-like, professional presentation of the findings is of 
paramount importance. Recognize that the facility may wish to respond to 
various findings. Although deficiency statements continue to depend, in 
part, on surveyor professional judgment, support your conclusions with 
resident-specific examples (identifiers other than names) whenever you 
can do so without compromising confidentiality. Before formally citing 
deficiencies, discuss any allegations or findings that could not be 
substantiated during earlier tasks in the process. For example, if 
information is gathered that suggests a newly hired

[[Page 399]]

R.N. is not currently licensed, ask the facility officials to present 
current licensure information for the nurse in question. Identify 
residents when the substandard care is readily observed or discerned 
through record review. Ensure that the facility improves the care 
provided to all affected residents, not only the identified residents. 
Make clear to the facility that during a follow-up visit the surveyors 
may review residents other than those with significant problems from the 
original sample, in order to see that the facility has corrected the 
problems overall. Do not disclose the source of information provided 
during interviews, unless the resident has specifically requested you to 
inform the facility of his/her comments or complaints. In accordance 
with your Agency's policy, present the Statement of Deficiencies, form 
CMS-2567, on site or after supervisory review, no later than 10 calendar 
days following the survey.
    (k) Plan of Correction. Explain to the facility that your role is to 
identify care and services which are not consistent with the regulatory 
requirements, rather than to ascertain the root causes of deficiencies. 
Each facility is expected to review its own care delivery. Subsequent to 
the exit conference, each facility is required to submit a plan of 
correction that identifies necessary changes in operation that will 
assure correction of the cited deficiencies. In reviewing and accepting 
a proposed plan of correction, apply these criteria:

     Does the facility have a reasonable approach for 
correcting the deficiencies?
     Is there a high probability that the planned 
action will result in compliance?
     Is compliance expected timely?

    Plans of correction specific to residents identified on the 
deficiency statement are acceptable only where the deficiency is 
determined to be unique to that resident and not indicative of a 
possible systemic problem. For example, as a result of an aide being 
absent, two residents are not ambulated three times that day as called 
for in their care plans. A plan of correction that says ``Ambulate John 
Jones and Mary Smith three times per day,'' is not acceptable. An 
acceptable plan of correction would explain changes made to the 
facility's staffing and scheduling in order to gurantee that staff is 
available to provide all necessary services for all residents.
    Acceptance of the plan of correction does not absolve the facility 
of the responsibility for compliance should the implementation not 
result in correction and compliance. Acceptance indicates the State 
agency's acknowledgement that the facility indicated a willingness and 
ability to make corrections adequately and timely.
    Allow the facility up to 10 days to prepare and submit the plan of 
correction to the State agency, however, follow your SA policy if the 
timeframe is shorter. Retain the various survey worksheets as well as 
the Survey Report Form at the State agency. Forward the deficiency 
statement to the CMS regional office.
    (l) Follow-up Surveys. The purpose of the follow-up survey is to re-
evaluate the specific types of care or care delivery patterns that were 
cited as deficient during the original survey. Ascertain the corrective 
status of all deficiencies cited on the CMS-2567. Because this survey 
process focuses on the actual provision of care and services, revisits 
are almost always necessary to ascertain whether the deficienicies have 
indeed been corrected. The nature of the deficiencies dictates the scope 
of the follow-up visit. Use as many tasks or portions of the Survey 
Report Form(s) as needed to ascertain compliance status. For example, 
you need not perform another drug pass if no drug related deficiencies 
were cited on the initial survey. Similarly, you need not repeat the 
dining area and eating assistance observations if no related problems 
were identified. All or some of the aspects of the observation/
interview/medical record review, however, are likely to be appropriate 
for the follow-up survey.
    When selecting the resident sample for the follow-up, determine the 
sample size using the same formula as used earlier in the survey, with 
the following exceptions:

     The maximum sample size is 30 residents, rather 
than 50.

[[Page 400]]

     The minimum sample size of 10 residents does not 
apply if only one care category was cited as deficient and the total 
number of residents in the facility in that category was less than 10 
(e.g., deficiency cited under catheter care and only five residents have 
catheters).

    Include in the sample those residents who, in your judgment, are 
appropriate for reviewing vis-a-vis the cited substandard care. If 
possible, include some residents identified as receiving substandard 
care during the initial survey. If after completing the follow-up 
activities you determine that the cited deficiencies were not corrected, 
initiate adverse action procedures, as appropriate.
    (m) Role of Surveyor. The survey and certification process is 
intended to determine whether providers and suppliers meet program 
participation requirements. The primary role of the surveyor, then, is 
to assess the quality of care and services and to relate those findings 
to statutory and regulatory requirements for program participation.
    When you find substandard care or services in the course of a 
survey, carefully document your findings. Explain the deficiency in 
sufficient detail so that the facility officials understand your 
rationale. If the cause of the deficiency is obvious, share the 
information with the provider. For example, if you cite a deficiency for 
restraints (F118), indicate that restraints were applied backwards on 
residents 1621, 1634, 1646, etc.
    In those instances where the cause is not obvious, do not delve into 
the facility's policies and procedures to determine the root cause of 
any deficiency. Do not recommend or prescribe an acceptable remedy. The 
provider is responsible for deciding on and implementing the action(s) 
necessary for achieving compliance. For the restraint situation in the 
example above, you would not ascertain whether the improper application 
was due to improper training or lack of training, nor would you attempt 
to identify the staff member who applied the restraints. It is the 
provider's responsibility to make the necessary changes or corrections 
to ensure that the restriants are applied properly.
    A secondary role for the surveyor is to provide general consultation 
to the provider/consumer community. This includes meeting with provider/
consumer associations and other groups as well as participating in 
seminars. It also includes informational activities, whereby you respond 
to oral or written inquiries about required outcomes in care and 
services.
    (n) Confidentiality and Respect for Resident Privacy. Conduct the 
survey in a manner that allows for the greatest degree of 
confidentiality for residents, particularly regarding the information 
gathered during the in-depth interviews. When recording observations 
about care and resident conditions, protect the privacy of all 
residents. Use a code such as resident identifier number rather than 
names on worksheets whenever possible. Never use a resident's name on 
the Deficiency Statement, Form CMS-2567. Block out resident names, if 
any, from any document that is disclosed to the facility, individual or 
organization.
    When communicating to the facility about substandard care, fully 
identify the resident(s) by name if the situation was identified through 
observation or record review. Improperly applied restraints, expired 
medication, cold food, gloves not worn for a sterile procedure, and diet 
inconsistent with order, are examples of problems which can be 
identified to the facility by resident name. Information about injuries 
due to broken equipment, prolonged use of restraints, and opened mail is 
less likely to be obtained through observation or record review. Do not 
reveal the source of information unless actually observed, discovered in 
the record review, or requested by the resident or family.
    (o) Team Composition. Whenever possible, use the following survey 
team model:

                        SNF/ICF Survey Team Model

    In facilities with 200 beds or less, the team size may range from 2 
to 4 members. If the team size is:

     2 members: The team has at least one RN plus 
another RN or a dietitian or a pharmacist.

[[Page 401]]

     3-4 member: In addition to the composition 
described above, the team has one or two members of any discipline such 
as a social worker, sanitarian, etc.

    If the facility has over 200 beds and the survey will last more than 
2 days, the team size may be greater than 4 members. Select additional 
disciplines as appropriate to the facility's compliance history.
    Average onsite time per survey: 60 person hours (Number of surveyors 
multiplied by the number of hours on site)
    Preferably, team members have gerontological training and 
experience. Any member may serve as the team leader, consistent with 
State agency procedures. In followup surveys, select disciplines based 
on major areas of correction. Include a social worker, for example, if 
the survey revealed major psychosocial problems. This model does not 
consider integrated survey and Inspection of Care review teams, which 
typically would be larger.
    (p) Type of Facility--Application of SNF or ICF Regulations. Apply 
the regulations to the various types of facilities in the following 
manner:

             Apply SNF regulations.
 Freestanding Skilled Nursing
 Facility (SNF)
             Apply ICF regulations.
 Freestanding Intermediate
 Care Facility (ICF)
 SNF         Apply SNF regulations.
 Distinct Part of a Hospital
 ICF         Apply ICF regulations.
 Distinct Part of a Hospital
 Dually      Apply SNF regulations and 442.346(b).
 Certified SNF/ICF
             Apply SNF regulations for SNF unit.
 Freestanding SNF with ICF     Apply ICF regulations for ICF distinct
 Distinct Part (Regardless of   part.
 the proportion of SNF and     Apply both SNF and ICF regulations for
 ICF beds, the facility type    shared services (e.g., dietary).
 is determined by the higher   If the same deficiency occurs in both the
 level of care. Therefore,      SNF and ICF components of the facility,
 LTC facilities with distinct   cite both SNF and ICF regulations.
 parts are defined as SNFs     If the deficiency occurs in the SNF part
 with ICF distinct parts.)      only, cite only the SNF regulation.
                               If the deficiency occurs in the ICF part
                                only, cite only the ICF regulation.
 

    (q) Use of Part A and Part B of the Survey Report--(1) Use of Part A 
(CMS-525). Use Part A for initial certification surveys only, except 
under the following circumstances:

     When a terminated facility requests program 
participation 60 days or more after termination. Treat this situation as 
a request for initial certification and complete Part A of the survey 
report in addition to Part B.
     If an ICF with a favorable compliance history 
requests to covert a number of beds to SNF level, complete both Part A 
and Part B for compliance with the SNF requirements. If distinct part 
status is at issue, also examine whether it meets the criteria for 
certification as a distinct part.

    (i) Addendum for Outpatient Physical Therapy (OPT) or Speech 
Pathology Services. Use the Outpatient Physical Therapy--Speech 
Pathology SRF (CMS-1893) as an addendum to Part A.
    (ii) Resurvey of Participating Facilities. Do not use Part A for 
resurveys of participating SNFs and ICFs. A determination of compliance, 
based on documented examination of the written policies and procedures 
and other pertinent documents during the initial survey, establishes the 
facility's compliance status with Part A requirements. This does not 
preclude citing deficiencies if they pertain to administrative or 
structural requirements from Part A that are uncovered incidental to a 
Part B survey. As an assurance measure, however, each facility at the 
time of recertification must complete an affidavit (on the CMS-1516) 
attesting that no substantive changes have occurred that would affect 
compliance. Each facility must also agree to notify the State agency 
immediately of any upcoming changes in its organization or management 
which may affect its compliance status. If a new administrator is unable 
to complete the affidavit, proceed with the survey using the Part B form 
and worksheets; do not use the Part A form. The survey cannot be 
considered complete, however, until the affidavit is signed. If the 
facility fails to complete the affidavit, it cannot participate in the 
program.
    (iii) Substantial Changes in a Facility's Organization and 
Management. If you receive such information, review the changes to 
ensure compliance with the regulations. Request copies of the 
appropriate documents (e.g., written policies and procedures, personnel 
qualifications, or agreements) if they were

[[Page 402]]

not submitted. If the changes have made continued compliance seem 
doubtful, determine through a Part B survey whether deficiencies have 
resulted. Cite any deficiencies on the CMS-2567 and follow the usual 
procedures.
    (2) Use of Part B (CMS-519). Use Part B and the worksheets for all 
types of SNF and ICF surveys--initials, recertifications, followup, 
complaints, etc.
    The worksheets are:

 CMS-520--Residents Selected for Indepth Review
 CMS-521--Tour Notes Worksheet
 CMS-522--Drug Pass Worksheet
 CMS-523--Dining Area and Eating Assistance Worksheet
 CMS-5245--Observation/Interview/Record Review 
    Worksheet

    For complaint investigations, perform a full or partial Part B 
survey based on the extent of the allegations. If the complaint alleges 
substandard care in a general fashion or in a variety of services and 
care areas, perform several tasks or a full Part B survey, as needed. If 
the complaint is of a more specific nature, such as an allegation of 
improper medications, perform an appropriate partial Part B survey, such 
as a drug pass review and a review of selected medical records.

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 Subpart D_Reconsideration of Adverse Determinations_Deeming Authority 
for Accreditation Organizations and CLIA Exemption of Laboratories Under 
                             State Programs

    Source: 57 FR 34012, July 31, 1992, unless otherwise noted.



Sec. 488.201  Reconsideration.

    (a) Right to reconsideration. (1) A national accreditation 
organization dissatisfied with a determination that its accreditation 
requirements do not provide (or do not continue to provide) reasonable 
assurance that the entities accredited by the accreditation organization 
meet the applicable long-term care requirements, conditions for 
coverage, conditions of certification, conditions of participation, or 
CLIA condition level requirements is entitled to a reconsideration as 
provided in this subpart.
    (2) A State dissatisfied with a determination that the requirements 
it imposes on laboratories in that State and under the laws of that 
State do not provide (or do not continue to provide) reasonable 
assurance that laboratories licensed or approved by the State meet 
applicable CLIA requirements is entitled to a reconsideration as 
provided in this subpart.
    (b) Eligibility for reconsideration. CMS will reconsider any 
determination to deny, remove or not renew the approval of deeming 
authority to private accreditation organizations, or any determination 
to deny, remove or not renew the approval of a State laboratory program 
for the purpose of exempting the State's laboratories from CLIA 
requirements, if the accreditation organization or State files a written 
request for a reconsideration in accordance with paragraphs (c) and (d) 
of this section.
    (c) Manner and timing of request for reconsideration. (1) A national 
accreditation organization or a State laboratory program described in 
paragraph (b), dissatisfied with a determination with respect to its 
deeming authority, or, in the case of a State, a determination with 
respect to the exemption of the laboratories in the State from CLIA 
requirements, may request a reconsideration of the determination by 
filing a request with CMS either directly by its authorized officials or 
through its legal representative. The request must be filed within 60 
days of the receipt of notice of an adverse determination or nonrenewal 
as provided in subpart A of part 488 or subpart E of part 493, as 
applicable.
    (2) Reconsideration procedures are available after the effective 
date of the decision to deny, remove, or not renew the approval of an 
accreditation organization or State laboratory program.
    (d) Content of request. The request for reconsideration must specify 
the findings or issues with which the accreditation organization or 
State disagrees and the reasons for the disagreement.

[57 FR 34012, July 31, 1992, as amended at 58 FR 61843, Nov. 23, 1993]



Sec. 488.203  Withdrawal of request for reconsideration.

    A requestor may withdraw its request for reconsideration at any time 
before the issuance of a reconsideration determination.



Sec. 488.205  Right to informal hearing.

    In response to a request for reconsideration, CMS will provide the 
accreditation organization or the State laboratory program the 
opportunity for an informal hearing as described in Sec. 488.207 that 
will--
    (a) Be conducted by a hearing officer appointed by the Administrator 
of CMS; and
    (b) Provide the accreditation organization or State laboratory 
program the opportunity to present, in writing or in person, evidence or 
documentation to refute the determination to deny approval, or to 
withdraw or not renew deeming authority or the exemption of a State's 
laboratories from CLIA requirements.



Sec. 488.207  Informal hearing procedures.

    (a) CMS will provide written notice of the time and place of the 
informal hearing at least 10 days before the scheduled date.
    (b) The informal reconsideration hearing will be conducted in 
accordance with the following procedures--

[[Page 541]]

    (1) The hearing is open to CMS and the organization requesting the 
reconsideration, including--
    (i) Authorized representatives;
    (ii) Technical advisors (individuals with knowledge of the facts of 
the case or presenting interpretation of the facts); and
    (iii) Legal counsel;
    (2) The hearing is conducted by the hearing officer who receives 
testimony and documents related to the proposed action;
    (3) Testimony and other evidence may be accepted by the hearing 
officer even though it would be inadmissable under the usual rules of 
court procedures;
    (4) Either party may call witnesses from among those individuals 
specified in paragraph (b)(1) of this section; and
    (5) The hearing officer does not have the authority to compel by 
subpoena the production of witnesses, papers, or other evidence.



Sec. 488.209  Hearing officer's findings.

    (a) Within 30 days of the close of the hearing, the hearing officer 
will present the findings and recommendations to the accreditation 
organization or State laboratory program that requested the 
reconsideration.
    (b) The written report of the hearing officer will include--
    (1) Separate numbered findings of fact; and
    (2) The legal conclusions of the hearing officer.



Sec. 488.211  Final reconsideration determination.

    (a) The hearing officer's decision is final unless the 
Administrator, within 30 days of the hearing officer's decision, chooses 
to review that decision.
    (b) The Administrator may accept, reject or modify the hearing 
officer's findings.
    (c) Should the Administrator choose to review the hearing officer's 
decision, the Administrator will issue a final reconsideration 
determination to the accreditation organization or State laboratory 
program on the basis of the hearing officer's findings and 
recommendations and other relevant information.
    (d) The reconsideration determination of the Administrator is final.
    (e) A final reconsideration determination against an accreditation 
organization or State laboratory program will be published by CMS in the 
Federal Register.



     Subpart E_Survey and Certification of Long-Term Care Facilities

    Source: 59 FR 56238, Nov. 10, 1994, unless otherwise noted.



Sec. 488.300  Statutory basis.

    Sections 1819 and 1919 of the Act establish requirements for 
surveying SNFs and NFs to determine whether they meet the requirements 
for participation in the Medicare and Medicaid programs.



Sec. 488.301  Definitions.

    As used in this subpart--
    Abbreviated standard survey means a survey other than a standard 
survey that gathers information primarily through resident-centered 
techniques on facility compliance with the requirements for 
participation. An abbreviated standard survey may be premised on 
complaints received; a change of ownership, management, or director of 
nursing; or other indicators of specific concern. Abbreviated standard 
surveys conducted to investigate a complaint or to conduct on-site 
monitoring to verify compliance with participation requirements are 
subject to the requirements of Sec. 488.332. Other premises for 
abbreviated standard surveys would follow the requirements of Sec. 
488.314.
    Abuse is the willful infliction of injury, unreasonable confinement, 
intimidation, or punishment with resulting physical harm, pain or mental 
anguish. Abuse also includes the deprivation by an individual, including 
a caretaker, of goods or services that are necessary to attain or 
maintain physical, mental, and psychosocial well-being. Instances of 
abuse of all residents, irrespective of any mental or physical 
condition, cause physical harm, pain or mental anguish. It includes 
verbal abuse, sexual abuse, physical abuse,

[[Page 542]]

and mental abuse including abuse facilitated or enabled through the use 
of technology. Willful, as used in this definition of abuse, means the 
individual must have acted deliberately, not that the individual must 
have intended to inflict injury or harm.
    Deficiency means a SNF's or NF's failure to meet a participation 
requirement specified in the Act or in part 483, subpart B of this 
chapter.
    Dually participating facility means a facility that has a provider 
agreement in both the Medicare and Medicaid programs.
    Extended survey means a survey that evaluates additional 
participation requirements subsequent to finding substandard quality of 
care during a standard survey.
    Facility means a SNF or NF, or a distinct part SNF or NF, in 
accordance with Sec. 483.5 of this chapter.
    Immediate family means husband or wife; natural or adoptive parent, 
child or sibling; stepparent, stepchild, stepbrother, or stepsister; 
father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-
law, or sister-in-law; grandparent or grandchild.
    Immediate jeopardy means a situation in which the provider's 
noncompliance with one or more requirements of participation has caused, 
or is likely to cause, serious injury, harm, impairment, or death to a 
resident.
    Misappropriation of resident property means the deliberate 
misplacement, exploitation, or wrongful, temporary or permanent use of a 
resident's belongings or money without the resident's consent.
    Neglect is the failure of the facility, its employees or service 
providers to provide goods and services to a resident that are necessary 
to avoid physical harm, pain, mental anguish, or emotional distress.
    Noncompliance means any deficiency that causes a facility to not be 
in substantial compliance.
    Nurse aide means an individual, as defined in Sec. 483.5 of this 
chapter.
    Nursing facility (NF) means a Medicaid nursing facility.
    Paid feeding assistant means an individual who meets the 
requirements specified in Sec. 483.60(h)(1) of this chapter and who is 
paid to feed residents by a facility, or who is used under an 
arrangement with another agency or organization.
    Partial extended survey means a survey that evaluates additional 
participation requirements subsequent to finding substandard quality of 
care during an abbreviated standard survey.
    Skilled nursing facility (SNF) means a Medicare nursing facility.
    Standard survey means a periodic, resident-centered inspection which 
gathers information about the quality of service furnished in a facility 
to determine compliance with the requirements for participation.
    Substandard quality of care means one or more deficiencies related 
to participation requirements under Sec. 483.10 ``Resident rights'', 
paragraphs (a)(1) through (a)(2), (b)(1) through (b)(2), (e) (except for 
(e)(2), (e)(7), and (e)(8)), (f)(1) through (f)(3), (f)(5) through 
(f)(8), and (i) of this chapter; Sec. 483.12 of this chapter ``Freedom 
from abuse, neglect, and exploitation''; Sec. 483.24 of this chapter 
``Quality of life''; Sec. 483.25 of this chapter ``Quality of care''; 
Sec. 483.40 ``Behavioral health services'', paragraphs (b) and (d) of 
this chapter; Sec. 483.45 ``Pharmacy services'', paragraphs (d), (e), 
and (f) of this chapter; Sec. 483.70 ``Administration'', paragraph (p) 
of this chapter, and Sec. 483.80 ``Infection control'', paragraph (d) 
of this chapter, which constitute either immediate jeopardy to resident 
health or safety; a pattern of or widespread actual harm that is not 
immediate jeopardy; or a widespread potential for more than minimal 
harm, but less than immediate jeopardy, with no actual harm.
    Substantial compliance means a level of compliance with the 
requirements of participation such that any identified deficiencies pose 
no greater risk to resident health or safety than the potential for 
causing minimal harm.
    Validation survey means a survey conducted by the Secretary within 2 
months following a standard survey, abbreviated standard survey, partial 
extended survey, or extended survey for the purpose of monitoring State 
survey agency performance.

[59 FR 56238, Nov. 10, 1994, as amended at 68 FR 55539, Sept. 26, 2003; 
81 FR 68871, Oct. 4, 2016; 82 FR 36635, Aug. 4, 2017]

[[Page 543]]



Sec. 488.303  State plan requirement.

    (a) A State plan must provide that the requirements of this subpart 
and subpart F of this part are met, to the extent that those 
requirements apply to the Medicaid program.
    (b) A State may establish a program to reward, through public 
recognition, incentive payments, or both, nursing facilities that 
provide the highest quality care to Medicaid residents. For purposes of 
section 1903(a)(7) of the Social Security Act, proper expenses incurred 
by a State in carrying out such a program are considered to be expenses 
necessary for the proper and efficient administration of the State plan.
    (c) A State must conduct periodic educational programs for the staff 
and residents (and their representatives) of NFs in order to present 
current regulations, procedures, and policies under this subpart and 
subpart F of this part.
    (d) Required remedies for a non-State operated NF. A State must 
establish, in addition to termination of the provider agreement, the 
following remedies or an approved alternative to the following remedies 
for imposition against a non-State operated NF:
    (1) Temporary management.
    (2) Denial of payment for new admissions.
    (3) Civil money penalties.
    (4) Transfer of residents.
    (5) Closure of the facility and transfer of residents.
    (6) State monitoring.
    (e) Optional remedies for a non-State operated NF. A State may 
establish the following remedies for imposition against a non-State 
operated NF:
    (1) Directed plan of correction.
    (2) Directed in-service training.
    (3) Alternative or additional State remedies.
    (f) Alternative or additional State remedies. If a State uses 
remedies that are in addition to those specified in paragraph (d) or (e) 
of this section, or alternative to those specified in paragraph (d) of 
this section (other than termination of participation), it must--
    (1) Specify those remedies in the State plan; and
    (2) Demonstrate to CMS's satisfaction that those alternative 
remedies are as effective in deterring noncompliance and correcting 
deficiencies as the remedies listed in paragraphs (d) and (e) of this 
section.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec. 488.305  Standard surveys.

    (a) For each SNF and NF, the State survey agency must conduct 
standard surveys that include all of the following:
    (1) A case-mix stratified sample of residents;
    (2) A survey of the quality of care furnished, as measured by 
indicators of medical, nursing, and rehabilitative care, dietary and 
nutrition services, activities and social participation, and sanitation, 
infection control, and the physical environment;
    (3) An audit of written plans of care and residents' assessments to 
determine the accuracy of such assessments and the adequacy of such 
plans of care; and
    (4) A review of compliance with residents' rights requirements set 
forth in sections 1819(c) and 1919(c) of the Act.
    (b) The State survey agency's failure to follow the procedures set 
forth in this section will not invalidate otherwise legitimate 
determinations that a facility's deficiencies exist.



Sec. 488.307  Unannounced surveys.

    (a) Basic rule. All standard surveys must be unannounced.
    (b) Review of survey agency's scheduling and surveying procedures. 
(1) CMS reviews on an annual basis each State survey agency's scheduling 
and surveying procedures and practices to ensure that survey agencies 
avoid giving notice of a survey through the scheduling procedures and 
the conduct of the surveys.
    (2) CMS takes corrective action in accordance with the nature and 
complexity of the problem when survey agencies are found to have 
notified a SNF or NF through their scheduling or procedural policies. 
Sanctions for inadequate survey performance are in accordance with Sec. 
488.320.
    (c) Civil money penalties. An individual who notifies a SNF or NF, 
or causes a SNF or NF to be notified, of the time or date on which a 
standard survey is scheduled to be conducted is

[[Page 544]]

subject to a Federal civil money penalty not to exceed $2,000 as 
adjusted annually under 45 CFR part 102.

[59 FR 56238, Nov. 10, 1994, as amended at 81 FR 61563, Sept. 6, 2016]



Sec. 488.308  Survey frequency.

    (a) Basic period. The survey agency must conduct a standard survey 
of each SNF and NF not later than 15 months after the last day of the 
previous standard survey.
    (b) Statewide average interval. (1) The statewide average interval 
between standard surveys must be 12 months or less, computed in 
accordance with paragraph (d) of this section.
    (2) CMS takes corrective action in accordance with the nature of the 
State survey agency's failure to ensure that the 12-month statewide 
average interval requirement is met. CMS's corrective action is in 
accordance with Sec. 488.320.
    (c) Other surveys. The survey agency may conduct a survey as 
frequently as necessary to--
    (1) Determine whether a facility complies with the participation 
requirements; and
    (2) Confirm that the facility has corrected deficiencies previously 
cited.
    (d) Computation of statewide average interval. The statewide average 
interval is computed at the end of each Federal fiscal year by comparing 
the last day of the most recent standard survey for each participating 
facility to the last day of each facility's previous standard survey.
    (e) Special surveys. (1) The survey agency may conduct a standard or 
an abbreviated standard survey to determine whether certain changes have 
caused a decline in the quality of care furnished by a SNF or a NF, 
within 60 days of a change in the following:
    (i) Ownership;
    (ii) Entity responsible for management of a facility (management 
firm);
    (iii) Nursing home administrator; or
    (iv) Director of nursing.
    (2) [Reserved]
    (f) Investigation of complaints. (1) The survey agency must review 
all complaint allegations and conduct a standard or an abbreviated 
survey to investigate complaints of violations of requirements by SNFs 
and NFs if its review of the allegation concludes that--
    (i) A deficiency in one or more of the requirements may have 
occurred; and
    (ii) Only a survey can determine whether a deficiency or 
deficiencies exist.
    (2) The survey agency does not conduct a survey if the complaint 
raises issues that are outside the purview of Federal participation 
requirements.

[53 FR 22859, June 17, 1988, as amended at 82 FR 36635, Aug. 4, 2017]



Sec. 488.310  Extended survey.

    (a) Purpose of survey. The purpose of an extended survey is to 
identify the policies and procedures that caused the facility to furnish 
substandard quality of care.
    (b) Scope of extended survey. An extended survey includes all of the 
following:
    (1) Review of a larger sample of resident assessments than the 
sample used in a standard survey.
    (2) Review of the staffing and in-service training.
    (3) If appropriate, examination of the contracts with consultants.
    (4) A review of the policies and procedures related to the 
requirements for which deficiencies exist.
    (5) Investigation of any participation requirement at the discretion 
of the survey agency.
    (c) Timing and basis for survey. The survey agency must conduct an 
extended survey not later than 14 calendar days after completion of a 
standard survey which found that the facility had furnished substandard 
quality of care.



Sec. 488.312  Consistency of survey results.

    CMS does and the survey agency must implement programs to measure 
accuracy and improve consistency in the application of survey results 
and enforcement remedies.



Sec. 488.314  Survey teams.

    (a) Team composition. (1) Surveys under sections 1819(g)(2) and 
1919(g)(2) of the Social Security Act must be conducted by an 
interdisciplinary team of professionals, which must include a registered 
nurse.

[[Page 545]]

    (2) Examples of professionals include, but are not limited to, 
physicians, physician assistants, nurse practitioners, physical, speech, 
or occupational therapists, registered professional nurses, dieticians, 
sanitarians, engineers, licensed practical nurses, or social workers.
    (3) The State determines what constitutes a professional, subject to 
CMS approval.
    (4) Any of the following circumstances disqualifies a surveyor for 
surveying a particular facility:
    (i) The surveyor currently works, or, within the past two years, has 
worked as an employee, as employment agency staff at the facility, or as 
an officer, consultant, or agent for the facility to be surveyed.
    (ii) The surveyor has any financial interest or any ownership 
interest in the facility.
    (iii) The surveyor has an immediate family member who has a 
relationship with a facility described in paragraphs (a)(4)(i) or 
paragraph (a)(4)(ii) of this section.
    (iv) The surveyor has an immediate family member who is a resident 
in the facility to be surveyed. For purposes of this section, an 
immediate family member is defined at Sec. 488.301 of this part.
    (b) CMS training. CMS provides comprehensive training to surveyors, 
including at least the following:
    (1) Application and interpretation of regulations for SNFs and NFs.
    (2) Techniques and survey procedures for conducting standard and 
extended surveys.
    (3) Techniques for auditing resident assessments and plans of care.
    (c) Required surveyor training. (1) Except as specified in paragraph 
(c)(3) of this section, the survey agency may not permit an individual 
to serve as a member of a survey team unless the individual has 
successfully completed a training and testing program prescribed by the 
Secretary.
    (2) The survey agency must have a mechanism to identify and respond 
to in-service training needs of the surveyors.
    (3) The survey agency may permit an individual who has not completed 
a training program to participate in a survey as a trainee if 
accompanied on-site by a surveyor who has successfully completed the 
required training and testing program.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995 as amended at 
82 FR 36636, Aug. 4, 2017]



Sec. 488.318  Inadequate survey performance.

    (a) CMS considers survey performance to be inadequate if the State 
survey agency--
    (1) Indicates a pattern of failure to--
    (i) Identify deficiencies and the failure cannot be explained by 
changed conditions in the facility or other case specific factors;
    (ii) Cite only valid deficiencies;
    (iii) Conduct surveys in accordance with the requirements of this 
subpart; or
    (iv) Use Federal standards, protocols, and the forms, methods and 
procedures specified by CMS in manual instructions; or
    (2) Fails to identify an immediate jeopardy situation.
    (b) Inadequate survey performance does not--
    (1) Relieve a SNF or NF of its obligation to meet all requirements 
for program participation; or
    (2) Invalidate adequately documented deficiencies.



Sec. 488.320  Sanctions for inadequate survey performance.

    (a) Annual assessment of survey performance. CMS assesses the 
performance of the State's survey and certification program annually.
    (b) Sanctions for inadequate survey performance. When a State 
demonstrates inadequate survey performance, as specified in Sec. 
488.318, CMS notifies the survey agency of the inadequacy and takes 
action in accordance with paragraphs (c) and (d) of this section.
    (c) Medicaid facilities. (1) For a pattern of failure to identify 
deficiencies in Medicaid facilities, CMS--
    (i) Reduces FFP, as specified in paragraph (e) of this section, and 
if appropriate;
    (ii) Provides for training of survey teams.

[[Page 546]]

    (2) For other survey inadequacies in Medicaid facilities, CMS 
provides for training of survey teams.
    (d) Medicare facilities. For all survey inadequacies in Medicare 
facilities, CMS--
    (1) Requires that the State survey agency submit a plan of 
correction;
    (2) Provides for training of survey teams;
    (3) Provides technical assistance on scheduling and procedural 
policies;
    (4) Provides CMS-directed scheduling; or
    (5) Initiates action to terminate the agreement between the 
Secretary and the State under section 1864 of the Act, either in whole 
or in part.
    (e) Reduction of FFP. In reducing FFP for inadequate survey 
performance, CMS uses the formula specified in section 1919(g)(3)(C) of 
the Act, that is 33 percent multiplied by a fraction--
    (1) The numerator of which is equal to the total number of residents 
in the NFs that CMS found to be noncompliant during validation surveys 
for that quarter; and
    (2) The denominator of which is equal to the total number of 
residents in the NFs in which CMS conducted validation surveys during 
that quarter.
    (f) Appeal of FFP reduction. When a State is dissatisfied with CMS's 
determination to reduce FFP, the State may appeal the determination to 
the Departmental Appeals Board, using the procedures specified in 45 CFR 
part 16.



Sec. 488.325  Disclosure of results of surveys and activities.

    (a) Information which must be provided to public. As provided in 
sections 1819(g)(5) and 1919(g)(5) of the Act, the following information 
must be made available to the public, upon the public's request, by the 
State or CMS for all surveys and certifications of SNFs and NFs:
    (1) Statements of deficiencies and providers' comments.
    (2) A list of isolated deficiencies that constitute no actual harm, 
with the potential for minimal harm.
    (3) Approved plans of correction.
    (4) Statements that the facility did not submit an acceptable plan 
of correction or failed to comply with the conditions of imposed 
remedies.
    (5) Final appeal results.
    (6) Notice of termination of a facility.
    (7) Medicare and Medicaid cost reports.
    (8) Names of individuals with direct or indirect ownership interest 
in a SNF or NF, as defined in Sec. 420.201 of this chapter.
    (9) Names of individuals with direct or indirect ownership interest 
in a SNF or NF, as defined in Sec. 420.201 of this chapter, who have 
been found guilty by a court of law of a criminal offense in violation 
of Medicare or Medicaid law.
    (b) Charge to public for information. CMS and the State may charge 
the public for specified services with respect to requests for 
information in accordance with--
    (1) Section 401.140 of this chapter, for Medicare; or
    (2) State procedures, for Medicaid.
    (c) How public can request information. The public may request 
information in accordance with disclosure procedures specified in 45 CFR 
part 5.
    (d) When information must be disclosed. The disclosing agency must 
make available to the public, upon the public's request, information 
concerning all surveys and certifications of SNFs and NFs, including 
statements of deficiencies, separate listings of any isolated 
deficiencies that constitute no actual harm, with the potential for 
minimal harm, and plans of correction (which contain any provider 
response to the deficiency statement) within 14 calendar days after each 
item is made available to the facility.
    (e) Procedures for responding to requests. The procedures and time 
periods for responding to requests are in accordance with--
    (1) Section 401.136 of this chapter for documents maintained by CMS; 
and
    (2) State procedures for documents maintained by the State.
    (f) Information that must be provided to the State's long-term care 
ombudsman. The State must provide the State's long-term care ombudsman 
with the following:
    (1) A statement of deficiencies reflecting facility noncompliance, 
including a separate list of isolated deficiencies that constitute no 
harm with the potential for minimal harm.

[[Page 547]]

    (2) Reports of adverse actions specified at Sec. 488.406 imposed on 
a facility.
    (3) Written response by the provider.
    (4) A provider's request for an appeal and the results of any 
appeal.
    (g) Information which must be provided to State by a facility with 
substandard quality of care. (1) To provide for the notice to physicians 
required under sections 1819(g)(5)(C) and 1919(g)(5)(C) of the Act, not 
later than 10 working days after receiving a notice of substandard 
quality of care, a SNF or NF must provide the State with a list of--
    (i) Each resident in the facility with respect to which such finding 
was made; and
    (ii) The name and address of his or her attending physician.
    (2) Failure to disclose the information timely will result in 
termination of participation or imposition of alternative remedies.
    (h) Information the State must provide to attending physician and 
State board. Not later than 20 calendar days after a SNF or NF complies 
with paragraph (g) of this section, the State must provide written 
notice of the noncompliance to--
    (1) The attending physician of each resident in the facility with 
respect to which a finding of substandard quality of care was made; and
    (2) The State board responsible for licensing the facility's 
administrator.
    (i) Access to information by State Medicaid fraud control unit. The 
State must provide access to any survey and certification information 
incidental to a SNF's or NF's participation in Medicare or Medicaid upon 
written request by the State Medicaid fraud control unit established 
under part 1007, of this title, consistent with current State laws.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec. 488.330  Certification of compliance or noncompliance.

    (a) General rules--(1) Responsibility for certification. (i) The 
State survey agency surveys all facilities for compliance or 
noncompliance with requirements for long term care facilities. The 
survey by the State survey agency may be followed by a Federal 
validation survey.
    (A) The State certifies the compliance or noncompliance of non-State 
operated NFs. Regardless of the State entity doing the certification, it 
is final, except in the case of a complaint or validation survey 
conducted by CMS, or CMS review of the State's findings.
    (B) CMS certifies the compliance or noncompliance of all State-
operated facilities.
    (C) The State survey agency certifies the compliance or 
noncompliance of a non-State operated SNF, subject to the approval of 
CMS.
    (D) The State survey agency certifies compliance or noncompliance 
for a dually participating SNF/NF. In the case of a disagreement between 
CMS and the State survey agency, a finding of noncompliance takes 
precedence over that of compliance.
    (ii) In the case of a validation survey, the Secretary's 
determination as to the facility's noncompliance is binding, and takes 
precedence over a certification of compliance resulting from the State 
survey.
    (2) Basis for certification. (i) Certification by the State is based 
on the survey agency findings.
    (ii) Certification by CMS is based on either the survey agency 
findings (in the case of State-operated facilities), or, in the case of 
a validation survey, on CMS's own survey findings.
    (b) Effect of certification--(1) Certification of compliance. A 
certification of compliance constitutes a determination that the 
facility is in substantial compliance and is eligible to participate in 
Medicaid as a NF, or in Medicare as a SNF, or in Medicare and Medicaid 
as a dually participating facility.
    (2) Certification of noncompliance. A certification of noncompliance 
requires denial of participation for prospective providers and 
enforcement action for current providers in accordance with subpart F of 
this part. Enforcement action must include one of the following:
    (i) Termination of any Medicare or Medicaid provider agreements that 
are in effect.
    (ii) Application of alternative remedies instead of, or in addition 
to, termination procedures.
    (c) Notice of certification of noncompliance and resulting action. 
The notice of

[[Page 548]]

certification of noncompliance is sent in accordance with the timeframes 
specified in Sec. 488.402(f), and resulting action is issued by CMS, 
except when the State is taking the action for a non-State operated NF.
    (d) Content of notice of certification of noncompliance. The notice 
of certification of noncompliance is sent in accordance with the 
timeframes specified in Sec. 488.402(f) and includes information on all 
of the following:
    (1) Nature of noncompliance.
    (2) Any alternative remedies to be imposed under subpart F of this 
part.
    (3) Any termination or denial of participation action to be taken 
under this part.
    (4) The appeal rights available to the facility under this part.
    (5) Timeframes to be met by the provider and certifying agency with 
regard to each of the enforcement actions or appeal procedures addressed 
in the notice.
    (e) Appeals. (1) Notwithstanding any provision of State law, the 
State must impose remedies promptly on any provider of services 
participating in the Medicaid program--
    (i) After promptly notifying the facility of the deficiencies and 
impending remedy or remedies; and
    (ii) Except for civil money penalties, during any pending hearing 
that may be requested by the provider of services.
    (2) CMS imposes remedies promptly on any provider of services 
participating in the Medicare or Medicaid program or any provider of 
services participating in both the Medicare and Medicaid programs--
    (i) After promptly notifying the facility of the deficiencies and 
impending remedy or remedies; and
    (ii) Except for civil money penalties imposed on NFs-only by the 
State, during any pending hearing that may be requested by the provider 
of services.
    (3) The provisions of part 498 of this chapter apply when the 
following providers request a hearing on a denial of participation, or 
certification of noncompliance leading to an enforcement remedy 
(including termination of the provider agreement), except State 
monitoring:
    (i) All State-operated facilities;
    (ii) SNFs and dually participating SNF/NFs; and
    (iii) Any other facilities subject to a CMS validation survey or CMS 
review of the State's findings.
    (4) The provisions of part 431 of this chapter apply when a non-
State operated Medicaid NF, which has not received a CMS validation 
survey or CMS review of the State's findings, requests a hearing on the 
State's denial of participation, termination of provider agreement, or 
certification of noncompliance leading to an alternative remedy, except 
State monitoring.
    (f) Provider agreements. CMS or the Medicaid agency may execute a 
provider agreement when a prospective provider is in substantial 
compliance with all the requirements for participation for a SNF or NF, 
respectively.
    (g) Special rules for Federal validation surveys. (1) CMS may make 
independent certifications of a NF's, SNF's, or dually participating 
facility's noncompliance based on a CMS validation survey.
    (2) CMS issues the notice of actions affecting facilities for which 
CMS did validation surveys.
    (3) For non-State-operated NFs and non-State-operated dually 
participating facilities, any disagreement between CMS and the State 
regarding the timing and choice of remedies is resolved in accordance 
with Sec. 488.452.
    (4) Either CMS or the survey agency, at CMS's option, may revisit 
the facility to ensure that corrections are made.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995; 76 FR 15126, 
Mar. 18, 2011]



Sec. 488.331  Informal dispute resolution.

    (a) Opportunity to refute survey findings. (1) For non-Federal 
surveys, the State must offer a facility an informal opportunity, at the 
facility's request, to dispute survey findings upon the facility's 
receipt of the official statement of deficiencies.
    (2) For Federal surveys, CMS offers a facility an informal 
opportunity, at the facility's request, to dispute survey findings upon 
the facility's receipt of the official statement of deficiencies.
    (3) For SNFs, dually-participating SNF/NFs, and NF-only facilities 
that have civil money penalties imposed by

[[Page 549]]

CMS that will be placed in a CMS escrow account, CMS also offers the 
facility an opportunity for independent informal dispute resolution, 
subject to the terms of paragraphs (b), (c), and (d) of this section and 
of Sec. 488.431. The facility must request independent informal dispute 
resolution in writing within 10 days of receipt of CMS's offer. However, 
a facility may not use the dispute resolution processes at both 
Sec. Sec. 488.331 and 488.431 for the same deficiency citation arising 
from the same survey unless the informal dispute resolution process at 
Sec. 488.331 was completed prior to the imposition of the civil money 
penalty.
    (b)(1) Failure of the State or CMS, as appropriate, to complete 
informal dispute resolution timely cannot delay the effective date of 
any enforcement action against the facility.
    (2) A facility may not seek a delay of any enforcement action 
against it on the grounds that informal dispute resolution has not been 
completed before the effective date of the enforcement action.
    (c) If a provider is subsequently successful, during the informal 
dispute resolution process, at demonstrating that deficiencies should 
not have been cited, the deficiencies are removed from the statement of 
deficiencies and any enforcement actions imposed solely as a result of 
those cited deficiencies are rescinded.
    (d) Notification. Upon request, CMS does and the State must provide 
the facility with written notification of the informal dispute 
resolution process.

[59 FR 56238, Nov. 10, 1994, as amended at 76 FR 15126, Mar. 18, 2011]



Sec. 488.332  Investigation of complaints of violations and monitoring
of compliance.

    (a) Investigation of complaints. (1) The State survey agency must 
establish procedures and maintain adequate staff to investigate 
complaints of violations of participation requirements.
    (2) The State survey agency takes appropriate precautions to protect 
a complainant's anonymity and privacy, if possible.
    (3) If arrangements have been made with other State components for 
investigation of complaints, the State must have a means of 
communicating information among appropriate entities, and the State 
survey agency retains responsibility for the investigation process.
    (4) If, after investigating a complaint, the State has reason to 
believe that an identifiable individual neglected or abused a resident, 
or misappropriated a resident's property, the State survey agency must 
act on the complaint in accordance with Sec. 488.335.
    (b) On-site monitoring. The State survey agency conducts on-site 
monitoring on an as necessary basis when--
    (1) A facility is not in substantial compliance with the 
requirements and is in the process of correcting deficiencies;
    (2) A facility has corrected deficiencies and verification of 
continued substantial compliance is needed; or
    (3) The survey agency has reason to question the substantial 
compliance of the facility with a requirement of participation.
    (c) Composition of the investigative team. A State may use a 
specialized team, which may include an attorney, auditor and appropriate 
health professionals, to identify, survey, gather and preserve evidence, 
and administer remedies to noncompliant facilities.



Sec. 488.334  Educational programs.

    A State must conduct periodic educational programs for the staff and 
residents (and their representatives) of SNFs and NFs in order to 
present current regulations, procedures, and policies on the survey, 
certification and enforcement process under this subpart and subpart F 
of this part.



Sec. 488.335  Action on complaints of resident neglect and abuse,
and misappropriation of resident property.

    (a) Investigation. (1) The State must review all allegations of 
resident neglect and abuse, and misappropriation of resident property 
and follow procedures specified in Sec. 488.332.
    (2) If there is reason to believe, either through oral or written 
evidence that an individual used by a facility to provide services to 
residents could have abused or neglected a resident or misappropriated a 
resident's property, the State must investigate the allegation.

[[Page 550]]

    (3) The State must have written procedures for the timely review and 
investigation of allegations of resident abuse and neglect, and 
misappropriation of resident property.
    (b) Source of complaints. The State must review all allegations 
regardless of the source.
    (c) Notification--(1) Individuals to be notified. If the State makes 
a preliminary determination, based on oral or written evidence and its 
investigation, that the abuse, neglect or misappropriation of property 
occurred, it must notify in writing--
    (i) The individuals implicated in the investigation; and
    (ii) The current administrator of the facility in which the incident 
occurred.
    (2) Timing of the notice. The State must notify the individuals 
specified in paragraph (c)(1) of this section in writing within 10 
working days of the State's investigation.
    (3) Contents of the notice. The notice must include the--
    (i) Nature of the allegation(s);
    (ii) Date and time of the occurrence;
    (iii) Right to a hearing;
    (iv) Intent to report the substantiated findings in writing, once 
the individual has had the opportunity for a hearing, to the nurse aide 
registry or appropriate licensure authority;
    (v) Fact that the individual's failure to request a hearing in 
writing within 30 days from the date of the notice will result in 
reporting the substantiated findings to the nurse aide registry or 
appropriate licensure authority.
    (vi) Consequences of waiving the right to a hearing;
    (vii) Consequences of a finding through the hearing process that the 
alleged resident abuse or neglect, or misappropriation of resident 
property did occur; and
    (viii) Fact that the individual has the right to be represented by 
an attorney at the individual's own expense.
    (d) Conduct of hearing. (1) The State must complete the hearing and 
the hearing record within 120 days from the day it receives the request 
for a hearing.
    (2) The State must hold the hearing at a reasonable place and time 
convenient for the individual.
    (e) Factors beyond the individual's control. A State must not make a 
finding that an individual has neglected a resident if the individual 
demonstrates that such neglect was caused by factors beyond the control 
of the individual.
    (f) Report of findings. If the finding is that the individual has 
neglected or abused a resident or misappropriated resident property or 
if the individual waives the right to a hearing, the State must report 
the findings in writing within 10 working days to--
    (1) The individual;
    (2) The current administrator of the facility in which the incident 
occurred; and
    (3) The administrator of the facility that currently employs the 
individual, if different than the facility in which the incident 
occurred;
    (4) The licensing authority for individuals used by the facility 
other than nurse aides, if applicable; and
    (5) The nurse aide registry for nurse aides. Only the State survey 
agency may report the findings to the nurse aide registry, and this must 
be done within 10 working days of the findings, in accordance with Sec. 
483.156(c) of this chapter. The State survey agency may not delegate 
this responsibility.
    (g) Contents and retention of report of finding to the nurse aide 
registry. (1) The report of finding must include information in 
accordance with Sec. 483.156(c) of this chapter.
    (2) The survey agency must retain the information as specified in 
paragraph (g)(1) of this section, in accordance with the procedures 
specified in Sec. 483.156(c) of this chapter.
    (h) Survey agency responsibility. (1) The survey agency must 
promptly review the results of all complaint investigations and 
determine whether or not a facility has violated any requirements in 
part 483, subpart B of this chapter.
    (2) If a facility is not in substantial compliance with the 
requirements in part 483, subpart B of this chapter, the survey agency 
initiates appropriate actions, as specified in subpart F of this part.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]

[[Page 551]]



 Subpart F_Enforcement of Compliance for Long-Term Care Facilities with 
                              Deficiencies

    Source: 59 FR 56243, Nov. 10, 1994, unless otherwise noted.



Sec. 488.400  Statutory basis.

    Sections 1819(h) and 1919(h) of the Act specify remedies that may be 
used by the Secretary or the State respectively when a SNF or a NF is 
not in substantial compliance with the requirements for participation in 
the Medicare and Medicaid programs. These sections also provide for 
ensuring prompt compliance and specify that these remedies are in 
addition to any other available under State or Federal law, and, except, 
for civil money penalties imposed on NFs-only by the State, are imposed 
prior to the conduct of a hearing.

[76 FR 15126, Mar. 18, 2011]



Sec. 488.401  Definitions.

    As used in this subpart--
    New admission means a resident who is admitted to the facility on or 
after the effective date of a denial of payment remedy and, if 
previously admitted, has been discharged before that effective date. 
Residents admitted before the effective date of the denial of payment, 
and taking temporary leave, are not considered new admissions, nor 
subject to the denial of payment.
    Plan of correction means a plan developed by the facility and 
approved by CMS or the survey agency that describes the actions the 
facility will take to correct deficiencies and specifies the date by 
which those deficiencies will be corrected.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec. 488.402  General provisions.

    (a) Purpose of remedies. The purpose of remedies is to ensure prompt 
compliance with program requirements.
    (b) Basis for imposition and duration of remedies. When CMS or the 
State chooses to apply one or more remedies specified in Sec. 488.406, 
the remedies are applied on the basis of noncompliance found during 
surveys conducted by CMS or by the survey agency.
    (c) Number of remedies. CMS or the State may apply one or more 
remedies for each deficiency constituting noncompliance or for all 
deficiencies constituting noncompliance.
    (d) Plan of correction requirement. (1) Except as specified in 
paragraph (d)(2) of this section, regardless of which remedy is applied, 
each facility that has deficiencies with respect to program requirements 
must submit a plan of correction for approval by CMS or the survey 
agency.
    (2) Isolated deficiencies. A facility is not required to submit a 
plan of correction when it has deficiencies that are isolated and have a 
potential for minimal harm, but no actual harm has occurred.
    (e) Disagreement regarding remedies. If the State and CMS disagree 
on the decision to impose a remedy, the disagreement is resolved in 
accordance with Sec. 488.452.
    (f) Notification requirements--(1) Except when the State is taking 
action against a non-State operated NF, CMS or the State (as authorized 
by CMS) gives the provider notice of the remedy, including the--
    (i) Nature of the noncompliance;
    (ii) Which remedy is imposed;
    (iii) Effective date of the remedy; and
    (iv) Right to appeal the determination leading to the remedy.
    (2) When a State is taking action against a non-State operated NF, 
the State's notice must include the same information required by CMS in 
paragraph (f)(1) of this section.
    (3) Immediate jeopardy--2 day notice. Except for civil money 
penalties and State monitoring imposed when there is immediate jeopardy, 
for all remedies specified in Sec. 488.406 imposed when there is 
immediate jeopardy, the notice must be given at least 2 calendar days 
before the effective date of the enforcement action.
    (4) No immediate jeopardy--15 day notice. Except for civil money 
penalties and State monitoring, notice must be given at least 15 
calendar days before the effective date of the enforcement action in 
situations in which there is no immediate jeopardy.
    (5) Date of enforcement action. The 2-and 15-day notice periods 
begin when the facility receives the notice.

[[Page 552]]

    (6) Civil money penalties. For civil money penalties, the notices 
must be given in accordance with the provisions of Sec. Sec. 488.434 
and 488.440.
    (7) State monitoring. For State monitoring, no prior notice is 
required.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999]



Sec. 488.404  Factors to be considered in selecting remedies.

    (a) Initial assessment. In order to select the appropriate remedy, 
if any, to apply to a facility with deficiencies, CMS and the State 
determine the seriousness of the deficiencies.
    (b) Determining seriousness of deficiencies. To determine the 
seriousness of the deficiency, CMS considers and the State must consider 
at least the following factors:
    (1) Whether a facility's deficiencies constitute--
    (i) No actual harm with a potential for minimal harm;
    (ii) No actual harm with a potential for more than minimal harm, but 
not immediate jeopardy;
    (iii) Actual harm that is not immediate jeopardy; or
    (iv) Immediate jeopardy to resident health or safety.
    (2) Whether the deficiencies--
    (i) Are isolated;
    (ii) Constitute a pattern; or
    (iii) Are widespread.
    (c) Other factors which may be considered in choosing a remedy 
within a remedy category. Following the initial assessment, CMS and the 
State may consider other factors, which may include, but are not limited 
to the following:
    (1) The relationship of the one deficiency to other deficiencies 
resulting in noncompliance.
    (2) The facility's prior history of noncompliance in general and 
specifically with reference to the cited deficiencies.



Sec. 488.406  Available remedies.

    (a) General. In addition to the remedy of termination of the 
provider agreement, the following remedies are available:
    (1) Temporary management.
    (2) Denial of payment including--
    (i) Denial of payment for all individuals, imposed by CMS, to a--
    (A) Skilled nursing facility, for Medicare;
    (B) State, for Medicaid; or
    (ii) Denial of payment for all new admissions.
    (3) Civil money penalties.
    (4) State monitoring.
    (5) Transfer of residents.
    (6) Closure of the facility and transfer of residents.
    (7) Directed plan of correction.
    (8) Directed in-service training.
    (9) Alternative or additional State remedies approved by CMS.
    (b) Remedies that must be established. At a minimum, and in addition 
to termination of the provider agreement, the State must establish the 
following remedies or approved alternatives to the following remedies:
    (1) Temporary management.
    (2) Denial of payment for new admissions.
    (3) Civil money penalties.
    (4) Transfer of residents.
    (5) Closure of the facility and transfer of residents.
    (6) State monitoring.
    (c) State plan requirement. If a State wishes to use remedies for 
noncompliance that are either additional or alternative to those 
specified in paragraphs (a) or (b) of this section, it must--
    (1) Specify those remedies in the State plan; and
    (2) Demonstrate to CMS's satisfaction that those remedies are as 
effective as the remedies listed in paragraph (a) of this section, for 
deterring noncompliance and correcting deficiencies.
    (d) State remedies in dually participating facilities. If the 
State's remedy is unique to the State plan and has been approved by CMS, 
then that remedy, as imposed by the State under its Medicaid authority, 
may be imposed by CMS against the Medicare provider agreement of a 
dually participating facility.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec. 488.408  Selection of remedies.

    (a) Categories of remedies. In this section, the remedies specified 
in Sec. 488.406(a) are grouped into categories and applied to 
deficiencies according to how serious the noncompliance is.

[[Page 553]]

    (b) Application of remedies. After considering the factors specified 
in Sec. 488.404, as applicable, if CMS and the State choose to impose 
remedies, as provided in paragraphs (c)(1), (d)(1) and (e)(1) of this 
section, for facility noncompliance, instead of, or in addition to, 
termination of the provider agreement, CMS does and the State must 
follow the criteria set forth in paragraphs (c)(2), (d)(2), and (e)(2) 
of this section, as applicable.
    (c) Category 1. (1) Category 1 remedies include the following:
    (i) Directed plan of correction.
    (ii) State monitoring.
    (iii) Directed in-service training.
    (2) CMS does or the State must apply one or more of the remedies in 
Category 1 when there--
    (i) Are isolated deficiencies that constitute no actual harm with a 
potential for more than minimal harm but not immediate jeopardy; or
    (ii) Is a pattern of deficiencies that constitutes no actual harm 
with a potential for more than minimal harm but not immediate jeopardy.
    (3) Except when the facility is in substantial compliance, CMS or 
the State may apply one or more of the remedies in Category 1 to any 
deficiency.
    (d) Category 2. (1) Category 2 remedies include the following:
    (i) Denial of payment for new admissions.
    (ii) Denial of payment for all individuals imposed only by CMS.
    (iii) Civil money penalties of $50-3,000 as adjusted annually under 
45 CFR part 102 per day.
    (iv) Civil money penalty of $1,000-$10,000 as adjusted annually 
under 45 CFR part 102 per instance of noncompliance.
    (2) CMS applies one or more of the remedies in Category 2, or, 
except for denial of payment for all individuals, the State must apply 
one or more of the remedies in Category 2 when there are--
    (i) Widespread deficiencies that constitute no actual harm with a 
potential for more than minimal harm but not immediate jeopardy; or
    (ii) One or more deficiencies that constitute actual harm that is 
not immediate jeopardy.
    (3) CMS or the State may apply one or more of the remedies in 
Category 2 to any deficiency except when--
    (i) The facility is in substantial compliance; or
    (ii) CMS or the State imposes a civil money penalty for a deficiency 
that constitutes immediate jeopardy, the penalty must be in the upper 
range of penalty amounts, as specified in Sec. 488.438(a).
    (e) Category 3. (1) Category 3 remedies include the following:
    (i) Temporary management.
    (ii) Immediate termination.
    (iii) Civil money penalties of $3,050-$10,000 as adjusted annually 
under 45 CFR part 102 per day.
    (iv) Civil money penalty of $1,000-$10,000 as adjusted annually 
under 45 CFR part 102 per instance of noncompliance.
    (2) When there are one or more deficiencies that constitute 
immediate jeopardy to resident health or safety--
    (i) CMS does and the State must do one or both of the following:
    (A) Impose temporary management; or
    (B) Terminate the provider agreement;
    (ii) CMS and the State may impose a civil money penalty of $3,050-
$10,000 as adjusted annually under 45 CFR part 102 per day or $1,000-
$10,000 as adjusted annually under 45 CFR part 102 per instance of 
noncompliance, in addition to imposing the remedies specified in 
paragraph (e)(2)(i) of this section.
    (3) When there are widespread deficiencies that constitute actual 
harm that is not immediate jeopardy, CMS and the State may impose 
temporary management, in addition to Category 2 remedies.
    (f) Plan of correction. (1) Except as specified in paragraph (f)(2) 
of this section, each facility that has a deficiency with regard to a 
requirement for long term care facilities must submit a plan of 
correction for approval by CMS or the State, regardless of--
    (i) Which remedies are imposed; or
    (ii) The seriousness of the deficiencies.
    (2) When there are only isolated deficiencies that CMS or the State 
determines constitute no actual harm with

[[Page 554]]

a potential for minimal harm, the facility need not submit a plan of 
correction.
    (g) Appeal of a certification of noncompliance. (1) A facility may 
appeal a certification of noncompliance leading to an enforcement 
remedy.
    (2) A facility may not appeal the choice of remedy, including the 
factors considered by CMS or the State in selecting the remedy, 
specified in Sec. 488.404.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999; 81 FR 61563, Sept. 6, 2016]



Sec. 488.410  Action when there is immediate jeopardy.

    (a) If there is immediate jeopardy to resident health or safety, the 
State must (and CMS does) either terminate the provider agreement within 
23 calendar days of the last date of the survey or appoint a temporary 
manager to remove the immediate jeopardy. The rules for appointment of a 
temporary manager in an immediate jeopardy situation are as follows:
    (1) CMS does and the State must notify the facility that a temporary 
manager is being appointed.
    (2) If the facility fails to relinquish control to the temporary 
manager, CMS does and the State must terminate the provider agreement 
within 23 calendar days of the last day of the survey, if the immediate 
jeopardy is not removed. In these cases, State monitoring may be imposed 
pending termination.
    (3) If the facility relinquishes control to the temporary manager, 
the State must (and CMS does) notify the facility that, unless it 
removes the immediate jeopardy, its provider agreement will be 
terminated within 23 calendar days of the last day of the survey.
    (4) CMS does and the State must terminate the provider agreement 
within 23 calendar days of the last day of survey if the immediate 
jeopardy has not been removed.
    (b) CMS or the State may also impose other remedies, as appropriate.
    (c)(1) In a NF or dually participating facility, if either CMS or 
the State finds that a facility's noncompliance poses immediate jeopardy 
to resident health or safety, CMS or the State must notify the other of 
such a finding.
    (2) CMS will or the State must do one or both of the following:
    (i) Take immediate action to remove the jeopardy and correct the 
noncompliance through temporary management.
    (ii) Terminate the facility's participation under the State plan. If 
this is done, CMS will also terminate the facility's participation in 
Medicare if it is a dually participating facility.
    (d) The State must provide for the safe and orderly transfer of 
residents when the facility is terminated.
    (e) If the immediate jeopardy is also substandard quality of care, 
the State survey agency must notify attending physicians and the State 
board responsible for licensing the facility administrator of the 
finding of substandard quality of care, as specified in Sec. 
488.325(h).

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec. 488.412  Action when there is no immediate jeopardy.

    (a) If a facility's deficiencies do not pose immediate jeopardy to 
residents' health or safety, and the facility is not in substantial 
compliance, CMS or the State may terminate the facility's provider 
agreement or may allow the facility to continue to participate for no 
longer than 6 months from the last day of the survey if--
    (1) The State survey agency finds that it is more appropriate to 
impose alternative remedies than to terminate the facility's provider 
agreement;
    (2) The State has submitted a plan and timetable for corrective 
action approved by CMS; and
    (3) The facility in the case of a Medicare SNF or the State in the 
case of a Medicaid NF agrees to repay to the Federal government payments 
received after the last day of the survey that first identified the 
deficiencies if corrective action is not taken in accordance with the 
approved plan of correction.
    (b) If a facility does not meet the criteria for continuation of 
payment under paragraph (a) of this section, CMS will and the State must 
terminate the facility's provider agreement.

[[Page 555]]

    (c) CMS does and the State must deny payment for new admissions when 
a facility is not in substantial compliance 3 months after the last day 
of the survey.
    (d) CMS terminates the provider agreement for SNFs and NFs, and 
stops FFP to a State for a NF for which participation was continued 
under paragraph (a) of this section, if the facility is not in 
substantial compliance within 6 months of the last day of the survey.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec. 488.414  Action when there is repeated substandard quality of care.

    (a) General. If a facility has been found to have provided 
substandard quality of care on the last three consecutive standard 
surveys, as defined in Sec. 488.305, regardless of other remedies 
provided--
    (1) CMS imposes denial of payment for all new admissions, as 
specified in Sec. 488.417, or denial of all payments, as specified in 
Sec. 488.418;
    (2) The State must impose denial of payment for all new admissions, 
as specified in Sec. 488.417; and
    (3) CMS does and the State survey agency must impose State 
monitoring, as specified in Sec. 488.422, until the facility has 
demonstrated to the satisfaction of CMS or the State, that it is in 
substantial compliance with all requirements and will remain in 
substantial compliance with all requirements.
    (b) Repeated noncompliance. For purposes of this section, repeated 
noncompliance is based on the repeated finding of substandard quality of 
care and not on the basis that the substance of the deficiency or the 
exact tag number for the deficiency was repeated.
    (c) Standard surveys to which this provision applies. Standard 
surveys completed by the State survey agency on or after October 1, 
1990, are used to determine whether the threshold of three consecutive 
standard surveys is met.
    (d) Program participation. (1) The determination that a certified 
facility has repeated instances of substandard quality of care is made 
without regard to any variances in the facility's program participation 
(that is, any standard survey completed for Medicare, Medicaid or both 
programs will be considered).
    (2) Termination would allow the count of repeated substandard 
quality of care surveys to start over.
    (3) Change of ownership. (i) A facility may not avoid a remedy on 
the basis that it underwent a change of ownership.
    (ii) In a facility that has undergone a change of ownership, CMS 
does not and the State may not restart the count of repeated substandard 
quality of care surveys unless the new owner can demonstrate to the 
satisfaction of CMS or the State that the poor past performance no 
longer is a factor due to the change in ownership.
    (e) Facility alleges corrections or achieves compliance after 
repeated substandard quality of care is identified. (1) If a penalty is 
imposed for repeated substandard quality of care, it will continue until 
the facility has demonstrated to the satisfaction of CMS or the State 
that it is in substantial compliance with the requirements and that it 
will remain in substantial compliance with the requirements for a period 
of time specified by CMS or the State.
    (2) A facility will not avoid the imposition of remedies or the 
obligation to demonstrate that it will remain in compliance when it--
    (i) Alleges correction of the deficiencies cited in the most recent 
standard survey; or
    (ii) Achieves compliance before the effective date of the remedies.



Sec. 488.415  Temporary management.

    (a) Definition. Temporary management means the temporary appointment 
by CMS or the State of a substitute facility manager or administrator 
with authority to hire, terminate or reassign staff, obligate facility 
funds, alter facility procedures, and manage the facility to correct 
deficiencies identified in the facility's operation.
    (b) Qualifications. The temporary manager must--
    (1) Be qualified to oversee correction of deficiencies on the basis 
of experience and education, as determined by the State;

[[Page 556]]

    (2) Not have been found guilty of misconduct by any licensing board 
or professional society in any State;
    (3) Have, or a member of his or her immediate family have, no 
financial ownership interest in the facility; and
    (4) Not currently serve or, within the past 2 years, have served as 
a member of the staff of the facility.
    (c) Payment of salary. The temporary manager's salary--
    (1) Is paid directly by the facility while the temporary manager is 
assigned to that facility; and
    (2) Must be at least equivalent to the sum of the following--
    (i) The prevailing salary paid by providers for positions of this 
type in what the State considers to be the facility's geographic area;
    (ii) Additional costs that would have reasonably been incurred by 
the provider if such person had been in an employment relationship; and
    (iii) Any other costs incurred by such a person in furnishing 
services under such an arrangement or as otherwise set by the State.
    (3) May exceed the amount specified in paragraph (c)(2) of this 
section if the State is otherwise unable to attract a qualified 
temporary manager.
    (d) Failure to relinquish authority to temporary management--(1) 
Termination of provider agreement. If a facility fails to relinquish 
authority to the temporary manager as described in this section, CMS 
will or the State must terminate the provider agreement in accordance 
with Sec. 488.456.
    (2) Failure to pay salary of temporary manager. A facility's failure 
to pay the salary of the temporary manager is considered a failure to 
relinquish authority to temporary management.
    (e) Duration of temporary management. Temporary management ends when 
the facility meets any of the conditions specified in Sec. 488.454(c).



Sec. 488.417  Denial of payment for all new admissions.

    (a) Optional denial of payment. Except as specified in paragraph (b) 
of this section, CMS or the State may deny payment for all new 
admissions when a facility is not in substantial compliance with the 
requirements, as defined in Sec. 488.401, as follows:
    (1) Medicare facilities. In the case of Medicare facilities, CMS may 
deny payment to the facility.
    (2) Medicaid facilities. In the case of Medicaid facilities--
    (i) The State may deny payment to the facility; and
    (ii) CMS may deny payment to the State for all new Medicaid 
admissions to the facility.
    (b) Required denial of payment. CMS does or the State must deny 
payment for all new admissions when--
    (1) The facility is not in substantial compliance, as defined in 
Sec. 488.401, 3 months after the last day of the survey identifying the 
noncompliance; or
    (2) The State survey agency has cited a facility with substandard 
quality of care on the last three consecutive standard surveys.
    (c) Resumption of payments: Repeated instances of substandard 
quality of care. When a facility has repeated instances of substandard 
quality of care, payments to the facility or, under Medicaid, CMS 
payments to the State on behalf of the facility, resume on the date 
that--
    (1) The facility achieves substantial compliance as indicated by a 
revisit or written credible evidence acceptable to CMS (for all 
facilities except non-State operated NFs against which CMS is imposing 
no remedies) or the State (for non-State operated NFs against which CMS 
is imposing no remedies); and
    (2) CMS (for all facilities except non-State operated NFs against 
which CMS is imposing no remedies) or the State (for non-State operated 
NFs against which CMS is imposing no remedies) believes that the 
facility is capable of remaining in substantial compliance.
    (d) Resumption of payments: No repeated instances of substandard 
quality of care. When a facility does not have repeated instances of 
substandard quality of care, payments to the facility or, under 
Medicaid, CMS payments to the State on behalf of the facility, resume 
prospectively on the date that the facility achieves substantial 
compliance, as indicated by a revisit or written credible evidence 
acceptable to CMS (under Medicare) or the State (under Medicaid).

[[Page 557]]

    (e) Restriction. No payments to a facility or, under Medicaid, CMS 
payments to the State on behalf of the facility, are made for the period 
between the date that the--
    (1) Denial of payment remedy is imposed; and
    (2) Facility achieves substantial compliance, as determined by CMS 
or the State.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec. 488.418  Secretarial authority to deny all payments.

    (a) CMS option to deny all payment. If a facility has not met a 
requirement, in addition to the authority to deny payment for all new 
admissions as specified in Sec. 488.417, CMS may deny any further 
payment for all Medicare residents in the facility and to the State for 
all Medicaid residents in the facility.
    (b) Prospective resumption of payment. Except as provided in 
paragraphs (d) and (e) of this section, if the facility achieves 
substantial compliance, CMS resumes payment prospectively from the date 
that it verifies as the date that the facility achieved substantial 
compliance.
    (c) Restriction on payment after denial of payment is imposed. If 
payment to the facility or to the State resumes after denial of payment 
for all residents, no payment is made for the period between the date 
that--
    (1) Denial of payment was imposed; and
    (2) CMS verifies as the date that the facility achieved substantial 
compliance.
    (d) Retroactive resumption of payment. Except when a facility has 
repeated instances of substandard quality of care, as specified in 
paragraph (e) of this section, when CMS or the State finds that the 
facility was in substantial compliance before the date of the revisit, 
or before CMS or the survey agency received credible evidence of such 
compliance, payment is resumed on the date that substantial compliance 
was achieved, as determined by CMS.
    (e) Resumption of payment--repeated instances of substandard care. 
When CMS denies payment for all Medicare residents for repeated 
instances of substandard quality of care, payment is resumed when--
    (1) The facility achieved substantial compliance, as indicated by a 
revisit or written credible evidence acceptable to CMS; and
    (2) CMS believes that the facility will remain in substantial 
compliance.



Sec. 488.422  State monitoring.

    (a) A State monitor--
    (1) Oversees the correction of deficiencies specified by CMS or the 
State survey agency at the facility site and protects the facility's 
residents from harm;
    (2) Is an employee or a contractor of the survey agency;
    (3) Is identified by the State as an appropriate professional to 
monitor cited deficiencies;
    (4) Is not an employee of the facility;
    (5) Does not function as a consultant to the facility; and
    (6) Does not have an immediate family member who is a resident of 
the facility to be monitored.
    (b) A State monitor must be used when a survey agency has cited a 
facility with substandard quality of care deficiencies on the last 3 
consecutive standard surveys.
    (c) State monitoring is discontinued when--
    (1) The facility has demonstrated that it is in substantial 
compliance with the requirements, and, if imposed for repeated instances 
of substandard quality of care, will remain in compliance for a period 
of time specified by CMS or the State; or
    (2) Termination procedures are completed.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec. 488.424  Directed plan of correction.

    CMS, the State survey agency, or the temporary manager (with CMS or 
State approval) may develop a plan of correction and CMS, the State, or 
the temporary manager require a facility to take action within specified 
timeframes.



Sec. 488.425  Directed inservice training.

    (a) Required training. CMS or the State agency may require the staff 
of a

[[Page 558]]

facility to attend an inservice training program if--
    (1) The facility has a pattern of deficiencies that indicate 
noncompliance; and
    (2) Education is likely to correct the deficiencies.
    (b) Action following training. After the staff has received 
inservice training, if the facility has not achieved substantial 
compliance, CMS or the State may impose one or more other remedies 
specified in Sec. 488.406.
    (c) Payment. The facility pays for directed inservice training.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec. 488.426  Transfer of residents, or closure of the facility 
and transfer of residents.

    (a) Transfer of residents, or closure of the facility and transfer 
of residents in an emergency. In an emergency, the State has the 
authority to--
    (1) Transfer Medicaid and Medicare residents to another facility; or
    (2) Close the facility and transfer the Medicaid and Medicare 
residents to another facility.
    (b) Required transfer when a facility's provider agreement is 
terminated. When the State or CMS terminates a facility's provider 
agreement, the State will arrange for the safe and orderly transfer of 
all Medicare and Medicaid residents to another facility, in accordance 
with Sec. 483.70(l) of this chapter.
    (c) Required notifications when a facility's provider agreement is 
terminated. When the State or CMS terminates a facility's provider 
agreement, CMS determines the appropriate date for notification, in 
accordance with Sec. 483.70(l) of this chapter.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
76 FR 9511, Feb. 18, 2011; 81 FR 68872, Oct. 4, 2016]



Sec. 488.430  Civil money penalties: Basis for imposing penalty.

    (a) CMS or the State may impose a civil money penalty for either the 
number of days a facility is not in substantial compliance with one or 
more participation requirements or for each instance that a facility is 
not in substantial compliance, regardless of whether or not the 
deficiencies constitute immediate jeopardy.
    (b) CMS or the State may impose a civil money penalty for the number 
of days of past noncompliance since the last standard survey, including 
the number of days of immediate jeopardy.

[59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13360, Mar. 18, 1999]



Sec. 488.431  Civil money penalties imposed by CMS and independent
informal dispute resolution: for SNFS, dually-participating SNF/NFs,
and NF-only facilities.

    (a) Opportunity for independent review. CMS retains ultimate 
authority for the survey findings and imposition of civil money 
penalties, but provides an opportunity for independent informal dispute 
resolution within 30 days of notice of imposition of a civil money 
penalty that will be placed in escrow in accordance with paragraph (b) 
of this section. An independent informal dispute resolution will--
    (1) Be completed within 60 days of facility's request if an 
independent informal dispute resolution is timely requested by the 
facility.
    (2) Generate a written record prior to the collection of the 
penalty.
    (3) Include notification to an involved resident or resident 
representative, as well as the State's long term care ombudsman, to 
provide opportunity for written comment.
    (4) Be approved by CMS and conducted by the State under section 1864 
of the Act, or by an entity approved by the State and CMS, or by CMS or 
its agent in the case of surveys conducted only by federal surveyors 
where the State independent dispute resolution process is not used, and 
which has no conflict of interest, such as:
    (i) A component of an umbrella State agency provided that the 
component is organizationally separate from the State survey agency.
    (ii) An independent entity with a specific understanding of Medicare 
and Medicaid program requirements selected by the State and approved by 
CMS.
    (5) Not include the survey findings that have already been the 
subject of an informal dispute resolution under

[[Page 559]]

Sec. 488.331 for the particular deficiency citations at issue in the 
independent process under Sec. 488.431, unless the informal dispute 
resolution under Sec. 488.331 was completed prior to the imposition of 
the civil money penalty.
    (b) Collection and placement in escrow account. (1) For both per day 
and per instance civil money penalties, CMS may collect and place the 
imposed civil money penalties in an escrow account on whichever of the 
following occurs first:
    (i) The date on which the independent informal dispute resolution 
process is completed under paragraph (a) of this section.
    (ii) The date that is 90 days after the date of the notice of 
imposition of the penalty.
    (2) For collection and placement in escrow accounts of per day civil 
money penalties, CMS may collect the portion of the per day civil money 
penalty that has accrued up to the time of collection as specified in 
paragraph (b)(1) of this section. CMS may make additional collections 
periodically until the full amount is collected, except that the full 
balance must be collected once the facility achieves substantial 
compliance or is terminated from the program and CMS determines the 
final amount of the civil money penalty imposed.
    (3) CMS may provide for an escrow payment schedule that differs from 
the collection times of paragraph (1) of this subsection in any case in 
which CMS determines that more time is necessary for deposit of the 
total civil money penalty into an escrow account, not to exceed 12 
months, if CMS finds that immediate payment would create substantial and 
undue financial hardship on the facility.
    (4) If the full civil money penalty is not placed in an escrow 
account within 30 calendar days from the date the provider receives 
notice of collection, or within 30 calendar days of any due date 
established pursuant to a hardship finding under paragraph (b)(3), CMS 
may deduct the amount of the civil money penalty from any sum then or 
later owed by CMS or the State to the facility in accordance with Sec. 
488.442(c).
    (5) For any civil money penalties that are not collected and placed 
into an escrow account under this section, CMS will collect such civil 
money penalties in the same manner as the State in accordance with Sec. 
488.432.
    (c) Maintenance of escrowed funds. CMS will maintain collected civil 
money penalties in an escrow account pending the resolution of any 
administrative appeal of the deficiency findings that comprise the basis 
for the civil monetary penalty imposition. CMS will retain the escrowed 
funds on an on-going basis and, upon a final administrative decision, 
will either return applicable funds in accordance with paragraph (d)(2) 
of this section or, in the case of an unsuccessful administrative 
appeal, will periodically disburse the funds to States or other entities 
in accordance with Sec. 488.433.
    (d) When a facility requests a hearing. (1) A facility must request 
a hearing on the determination of the noncompliance that is the basis 
for imposition of the civil money penalty as specified in Sec. 498.40 
of this chapter.
    (2) If the administrative law judge reverses deficiency findings 
that comprise the basis of a civil money penalty in whole or in part, 
the escrowed amounts continue to be held pending expiration of the time 
for CMS to appeal the decision or, where CMS does appeal, a Departmental 
Appeals Board decision affirming the reversal of the pertinent 
deficiency findings. Any collected civil money penalty amount owed to 
the facility based on a final administrative decision will be returned 
to the facility with applicable interest as specified in section 
1878(f)(2) of the Act.

[76 FR 15126, Mar. 18, 2011]



Sec. 488.432  Civil money penalties imposed by the State: NF-only.

    (a) When a facility requests a hearing. (1) When the State imposes a 
civil money penalty against a non-State operated NF that is not subject 
to imposition of remedies by CMS, the facility must request a hearing on 
the determination of noncompliance that is the basis for imposition of 
the civil money penalty within the time specified in Sec. 431.153 of 
this chapter.
    (2)(i) If a facility requests a hearing within the time frame 
specified in paragraph (a)(1) of this section, for a

[[Page 560]]

civil money penalty imposed per day, the State initiates collection of 
the penalty when there is a final administrative decision that upholds 
the State's determination of noncompliance after the facility achieves 
substantial compliance or is terminated.
    (ii) If a facility requests a hearing for a civil money penalty 
imposed per instance of noncompliance within the time specified in 
paragraph (a)(1) of this section, the State initiates collection of the 
penalty when there is a final administrative decision that upholds the 
State's determination of noncompliance.
    (b) When a facility does not request a hearing for a civil money 
penalty imposed per day. (1) If a facility does not request a hearing in 
accordance with paragraph (a) of this section, the State initiates 
collection of the penalty when the facility--
    (i) Achieves substantial compliance; or
    (ii) Is terminated.
    (2) When a facility does not request a hearing for a civil money 
penalty imposed per instance of noncompliance. If a facility does not 
request a hearing in accordance with paragraph (a) of this section, the 
State initiates collection of the penalty when the time frame for 
requesting a hearing expires.
    (c) When a facility waives a hearing. (1) If a facility waives, in 
writing, its right to a hearing as specified in Sec. 488.436, for a 
civil money penalty imposed per day, the State initiates collection of 
the penalty when the facility--
    (i) Achieves substantial compliance; or (ii) Is terminated.
    (2) If a facility waives, in writing, its right to a hearing as 
specified in Sec. 488.436, the State initiates collection of civil 
money penalty imposed per instance of noncompliance upon receipt of the 
facility's notification.
    (d) Accrual and computation of penalties for a facility that--
    (1) Requests a hearing or does not request a hearing are specified 
in Sec. 488.440;
    (2) Waives its right to a hearing in writing, are specified in 
Sec. Sec. 488.436(b) and 488.440.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999; 76 FR 15127, Mar. 18, 2011]



Sec. 488.433  Civil money penalties: Uses and approval of civil money
penalties imposed by CMS.

    (a) Ten percent of the collected civil money penalty funds that are 
required to be held in escrow pursuant to Sec. 488.431 and that remain 
after a final administrative decision will be deposited with the 
Department of the Treasury in accordance with Sec. 488.442(f). The 
remaining ninety percent of the collected civil money penalty funds that 
are required to be held in escrow pursuant to Sec. 488.431 and that 
remain after a final administrative decision must be used entirely for 
activities that protect or improve the quality of care or quality of 
life for residents consistent with paragraph (b) of this section and may 
not be used for survey and certification operations or State expenses, 
except that reasonable expenses necessary to administer, monitor, or 
evaluate the effectiveness of projects utilizing civil money penalty 
funds may be permitted.
    (b) All activities and plans for utilizing civil money penalty 
funds, including any expense used to administer grants utilizing civil 
money penalty funds, must be approved in advance by CMS and may include, 
but are not limited to:
    (1) Support and protection of residents of a facility that closes 
(voluntarily or involuntarily).
    (2) Time-limited expenses incurred in the process of relocating 
residents to home and community-based settings or another facility when 
a facility is closed (voluntarily or involuntarily) or downsized 
pursuant to an agreement with the State Medicaid agency.
    (3) Projects that support resident and family councils and other 
consumer involvement in assuring quality care in facilities.
    (4) Facility improvement initiatives, such as joint training of 
facility staff and surveyors or technical assistance

[[Page 561]]

for facilities implementing quality assurance and performance 
improvement programs.
    (5) Development and maintenance of temporary management or 
receivership capability such as but not limited to, recruitment, 
training, retention or other system infrastructure expenses. However, as 
specified in Sec. 488.415(c), a temporary manager's salary must be paid 
by the facility. In rare situations, if the facility is closing, CMS 
plans to stop or suspend continued payments to the facility under Sec. 
489.55 of this chapter during the temporary manager's duty period, and 
CMS determines that extraordinary action is necessary to protect the 
residents until relocation efforts are successful, civil money penalty 
funds may be used to pay the manager's salary.
    (c) At a minimum, proposed activities submitted to CMS for prior 
approval must include a description of the intended outcomes, 
deliverables, and sustainability; and a description of the methods by 
which the activity results will be assessed, including specific 
measures.
    (d) Civil money penalty funds may not be used for activities that 
have been disapproved by CMS.
    (e) The State must maintain an acceptable plan, approved by CMS, for 
the effective use of civil money funds, including a description of 
methods by which the State will:
    (1) Solicit, accept, monitor, and track projects utilizing civil 
money penalty funds including any funds used for state administration.
    (2) Make information about the use of civil money penalty funds 
publicly available, including about the dollar amount awarded for 
approved projects, the grantee or contract recipients, the results of 
projects, and other key information.
    (3) Ensure that:
    (i) A core amount of civil money penalty funds will be held in 
reserve for emergencies, such as relocation of residents pursuant to an 
involuntary termination from Medicare and Medicaid.
    (ii) A reasonable amount of funds, beyond those held in reserve 
under paragraph (e)(3)(i) of this section, will be awarded or contracted 
each year for the purposes specified in this section.
    (f) If CMS finds that a State has not spent civil money penalty 
funds in accordance with this section, or fails to make use of funds to 
benefit the quality of care or life of residents, or fails to maintain 
an acceptable plan for the use of funds that is approved by CMS, then 
CMS may withhold future disbursements of civil money penalty funds to 
the State until the State has submitted an acceptable plan to comply 
with this section.

[79 FR 45658, Aug. 5, 2014]



Sec. 488.434  Civil money penalties: Notice of penalty.

    (a) CMS notice of penalty. (1) CMS sends a written notice of the 
penalty to the facility for all facilities except non-State operated NFs 
when the State is imposing the penalty.
    (2) Content of notice. The notice that CMS sends includes--
    (i) The nature of the noncompliance;
    (ii) The statutory basis for the penalty;
    (iii) The amount of penalty per day of noncompliance or the amount 
of the penalty per instance of noncompliance;
    (iv) Any factors specified in Sec. 488.438(f) that were considered 
when determining the amount of the penalty;
    (v) The date of the instance of noncompliance or the date on which 
the penalty begins to accrue;
    (vi) When the penalty stops accruing, if applicable;
    (vii) When the penalty is collected; and
    (viii) Instructions for responding to the notice, including a 
statement of the facility's right to a hearing, and the implication of 
waiving a hearing, as provided in Sec. 488.436.
    (b) State notice of penalty. (1) The State must notify the facility 
in accordance with State procedures for all non-State operated NFs when 
the State takes the action.
    (2) The State's notice must--
    (i) Be in writing; and
    (ii) Include, at a minimum, the information specified in paragraph 
(a)(2) of this section.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999]

[[Page 562]]



Sec. 488.436  Civil money penalties: Waiver of hearing, reduction 
of penalty amount.

    (a) Waiver of a hearing. The facility may waive the right to a 
hearing, in writing, within 60 days from the date of the notice imposing 
the civil money penalty.
    (b) Reduction of penalty amount. (1) If the facility waives its 
right to a hearing in accordance with the procedures specified in 
paragraph (a) of this section, CMS or the State reduces the civil money 
penalty by 35 percent, as long as the civil money penalty has not also 
been reduced by 50 percent under Sec. 488.438.
    (2) If the facility does not waive its right to a hearing in 
accordance with the procedures specified in paragraph (a) of this 
section, the civil money penalty is not reduced by 35 percent.

[59 FR 56243, Nov. 10, 1994; 62 FR 44221, Aug. 20, 1997; 76 FR 15127, 
Mar. 18, 2011]



Sec. 488.438  Civil money penalties: Amount of penalty.

    (a) Amount of penalty. (1) The penalties are within the following 
ranges, set at $50 increments:
    (i) Upper range. Penalties in the range of $3,050-$10,000 as 
adjusted annually under 45 CFR part 102 per day are imposed for 
deficiencies constituting immediate jeopardy, and as specified in 
paragraph (d)(2) of this section.
    (ii) Upper range. Penalties in the range of $50-$3,000 as adjusted 
annually under 45 CFR part 102 per day are imposed for deficiencies that 
do not constitute immediate jeopardy, but either caused actual harm, or 
caused no actual harm, but have the potential for more than minimal 
harm.
    (2) Per instance penalty. When penalties are imposed for an instance 
of noncompliance, the penalties will be in the range of $1,000-$10,000 
as adjusted annually under 45 CFR part 102 per instance.
    (b) Basis for penalty amount. The amount of penalty is based on 
CMS's or the State's assessment of factors listed in paragraph (f) of 
this section.
    (c) Decreased penalty amounts. (1) Except as specified in paragraph 
(d)(2) of this section, if immediate jeopardy is removed, but the 
noncompliance continues, CMS or the State will shift the penalty amount 
imposed per day to the lower range.
    (2) When CMS determines that a SNF, dually-participating SNF/NF, or 
NF-only facility subject to a civil money penalty imposed by CMS self-
reports and promptly corrects the noncompliance for which the civil 
money penalty was imposed, CMS will reduce the amount of the penalty by 
50 percent, provided that all of the following apply --
    (i) The facility self-reported the noncompliance to CMS or the State 
before it was identified by CMS or the State and before it was reported 
to CMS or the State by means of a complaint lodged by a person other 
than an official representative of the nursing home;
    (ii) Correction of the self-reported noncompliance occurred on 
whichever of the following occurs first:
    (A) 15 calendar days from the date of the circumstance or incident 
that later resulted in a finding of noncompliance; or
    (B) 10 calendar days from the date the civil money penalty was 
imposed;
    (iii) The facility waives its right to a hearing under Sec. 
488.436;
    (iv) The noncompliance that was self-reported and corrected did not 
constitute a pattern of harm, widespread harm, immediate jeopardy, or 
result in the death of a resident;
    (v) The civil money penalty was not imposed for a repeated 
deficiency, as defined in paragraph (d)(3) of this section, that was the 
basis of a civil money penalty that previously received a reduction 
under this section; and
    (vi) The facility has met mandatory reporting requirements for the 
incident or circumstance upon which the civil money penalty is based, as 
required by Federal and State law.
    (3) Under no circumstances will a facility receive both the 50 
percent civil money penalty reduction for self-reporting and correcting 
under this section and the 35 percent civil money penalty reduction for 
waiving its right to a hearing under Sec. 488.436.
    (d) Increased penalty amounts. (1) Before a hearing requested in 
accordance with Sec. 488.431(d) or Sec. 488.432(a), CMS or the State 
may propose to increase the

[[Page 563]]

per day penalty amount for facility noncompliance which, after 
imposition of a lower level penalty amount, becomes sufficiently serious 
to pose immediate jeopardy.
    (2) CMS does and the State must increase the per day penalty amount 
for any repeated deficiencies for which a lower level penalty amount was 
previously imposed, regardless of whether the increased penalty amount 
would exceed the range otherwise reserved for nonimmediate jeopardy 
deficiencies.
    (3) Repeated deficiencies are deficiencies in the same regulatory 
grouping of requirements found at the last survey, subsequently 
corrected, and found again at the next survey.
    (e) Review of the penalty. When an administrative law judge or State 
hearing officer (or higher administrative review authority) finds that 
the basis for imposing a civil money penalty exists, as specified in 
Sec. 488.430, the administrative law judge or State hearing officer (or 
higher administrative review authority) may not--
    (1) Set a penalty of zero or reduce a penalty to zero;
    (2) Review the exercise of discretion by CMS or the State to impose 
a civil money penalty; and
    (3) Consider any factors in reviewing the amount of the penalty 
other than those specified in paragraph (f) of this section.
    (f) Factors affecting the amount of penalty. In determining the 
amount of penalty, CMS does or the State must take into account the 
following factors:
    (1) The facility's history of noncompliance, including repeated 
deficiencies.
    (2) The facility's financial condition.
    (3) The factors specified in Sec. 488.404.
    (4) The facility's degree of culpability. Culpability for purposes 
of this paragraph includes, but is not limited to, neglect, 
indifference, or disregard for resident care, comfort or safety. The 
absence of culpability is not a mitigating circumstance in reducing the 
amount of the penalty.

[59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13360, Mar. 18, 1999; 
68 FR 46072, Aug. 4, 2003; 76 FR 15127, Mar. 18, 2011; 81 FR 61563, 
Sept. 6, 2016]



Sec. 488.440  Civil money penalties: Effective date and duration
of penalty.

    (a)(1) The per day civil money penalty may start accruing as early 
as the date that the facility was first out of compliance, as determined 
by CMS or the State.
    (2) A civil money penalty for each instance of noncompliance is 
imposed in a specific amount for that particular deficiency .
    (b) The per day civil money penalty is computed and collectible, as 
specified in Sec. Sec. 488.431, 488.432, and 488.442 for the number of 
days of noncompliance until the date the facility achieves substantial 
compliance, or, if applicable, the date of termination when --
    (1) The determination of noncompliance is upheld after a final 
administrative decision for NFs-only subject to civil money penalties 
imposed by the state or for civil money penalties imposed by CMS that 
are not collected and placed into an escrow account;
    (2) The facility waives its right to a hearing in accordance with 
Sec. 488.436; or
    (3) The time for requesting a hearing has expired and CMS or the 
State has not received a hearing request from the facility.
    (c)(1) For NFs-only subject to civil money penalties imposed by the 
State and for civil money penalties imposed by CMS that may not be 
placed in an escrow account, the entire penalty, whether imposed on a 
per day or per instance basis, is due and collectible as specified in 
the notice sent to the provider under paragraphs (d) and (e) of this 
section.
    (2) For SNFs, dually-participating SNF/NFs, or NFs subject to civil 
money penalties imposed by CMS, collection is made in accordance with 
Sec. 488.431.
    (d)(1) When a civil money penalty is imposed on a per day basis and 
the facility achieves substantial compliance, CMS does or the State must 
send a separate notice to the facility containing the following 
information:
    (i) The amount of penalty per day.
    (ii) The number of days involved.
    (iii) The total amount due.
    (iv) The due date of the penalty.
    (v) The rate of interest assessed on the unpaid balance beginning on 
the due date, as provided in Sec. 488.442.

[[Page 564]]

    (2) When a civil money penalty is imposed for an instance of 
noncompliance, CMS does or the State must send a separate notice to the 
facility containing the following information:
    (i) The amount of the penalty.
    (ii) The total amount due.
    (iii) The due date of the penalty.
    (iv) The rate of interest assessed on the unpaid balance beginning 
on the due date, as provided in Sec. 488.442.
    (e) In the case of a facility for which the provider agreement has 
been terminated and on which a civil money penalty was imposed on a per 
day basis, CMS does or the State must send this penalty information 
after the--
    (1) Final administrative decision is made;
    (2) Facility has waived its right to a hearing in accordance with 
Sec. 488.436; or
    (3) Time for requesting a hearing has expired and CMS or the state 
has not received a hearing request from the facility.
    (f) Accrual of penalties when there is no immediate jeopardy. (1) In 
the case of noncompliance that does not pose immediate jeopardy, the 
daily accrual of per day civil money penalties is imposed for the days 
of noncompliance prior to the notice specified in Sec. 488.434 and an 
additional period of no longer than 6 months following the last day of 
the survey.
    (2) After the period specified in paragraph (f)(1) of this section, 
if the facility has not achieved substantial compliance, CMS terminates 
the provider agreement and the State may terminate the provider 
agreement.
    (g)(1) In a case when per day civil money penalties are imposed, 
when a facility has deficiencies that pose immediate jeopardy, CMS does 
or the State must terminate the provider agreement within 23 calendar 
days after the last day of the survey if the immediate jeopardy remains.
    (2) The accrual of the civil money penalty imposed on a per day 
basis stops on the day the provider agreement is terminated.
    (h)(1) If an on-site revisit is necessary to confirm substantial 
compliance and the provider can supply documentation acceptable to CMS 
or the State agency that substantial compliance was achieved on a date 
preceding the revisit, penalties imposed on a per day basis only accrue 
until that date of correction for which there is written credible 
evidence.
    (2) If an on-site revisit is not necessary to confirm substantial 
compliance, penalties imposed on a per day basis only accrue until the 
date of correction for which CMS or the State receives and accepts 
written credible evidence.

[59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13361, Mar. 18, 1999; 
76 FR 15128, Mar. 18, 2011]



Sec. 488.442  Civil money penalties: Due date for payment of penalty.

    (a) When payments are due for a civil money penalty. (1) Payment for 
a civil money penalty is due in accordance with Sec. 488.431 of this 
chapter for CMS-imposed penalties and 15 days after the State initiates 
collection pursuant to Sec. 488.432 of this chapter for State-imposed 
penalties, except as provided in paragraphs (a)(2) and (3) of this 
section.
    (2) After a request to waive a hearing or when a hearing was not 
requested. Except as provided for in Sec. 488.431, a civil money 
penalty is due 15 days after receipt of a written request to waive a 
hearing in accordance with Sec. 488.436 or 15 days after the time 
period for requesting a hearing has expired and a hearing request was 
not received when:
    (i) The facility achieved substantial compliance before the hearing 
request was due; or
    (ii) The effective date of termination occurs before the hearing 
request was due.
    (3) After the effective date of termination. A civil money penalty 
payment is due 15 days after the effective date of termination, if that 
date is earlier than the date specified in paragraph (a)(1)of this 
section.
    (b) [Reserved]
    (c) Deduction of penalty from amount owed. The amount of the 
penalty, when determined, may be deducted from any sum then or later 
owing by CMS or the State to the facility.
    (d) Interest--(1) Assessment. Interest is assessed on the unpaid 
balance of the penalty, beginning on the due date.
    (2) Medicare interest. Medicare rate of interest is the higher of--

[[Page 565]]

    (i) The rate fixed by the Secretary of the Treasury after taking 
into consideration private consumer rates of interest prevailing on the 
date of the notice of the penalty amount due (published quarterly in the 
Federal Register by HHS under 45 CFR 30.13(a)); or
    (ii) The current value of funds (published annually in the Federal 
Register by the Secretary of the Treasury, subject to quarterly 
revisions).
    (3) Medicaid interest. The interest rate for Medicaid is determined 
by the State.
    (e) Penalties collected by CMS. Civil money penalties and 
corresponding interest collected by CMS from--
    (1) Medicare-participating facilities are deposited and disbursed in 
accordance with Sec. 488.433; and
    (2) Medicaid-participating facilities are returned to the State.
    (f) Collection from dually participating facilities. Civil money 
penalties collected from dually participating facilities are deposited 
and disbursed in accordance with Sec. 488.433 and returned to the State 
in proportion commensurate with the relative proportions of Medicare and 
Medicaid beds at the facility actually in use by residents covered by 
the respective programs on the date the civil money penalty begins to 
accrue.
    (g) Penalties collected by the State. Civil money penalties 
collected by the State must be applied to the protection of the health 
or property of residents of facilities that the State or CMS finds 
noncompliant, such as--
    (1) Payment for the cost of relocating residents to other 
facilities;
    (2) State costs related to the operation of a facility pending 
correction of deficiencies or closure; and
    (3) Reimbursement of residents for personal funds or property lost 
at a facility as a result of actions by the facility or by individuals 
used by the facility to provide services to residents.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13361, Mar. 18, 1999; 76 FR 15128, Mar. 18, 2011]



Sec. 488.444  Civil money penalties: Settlement of penalties.

    (a) CMS has authority to settle cases at any time prior to a final 
administrative decision for Medicare-only SNFs, State-operated 
facilities, or other facilities for which CMS's enforcement action 
prevails, in accordance with Sec. 488.330.
    (b) The State has the authority to settle cases at any time prior to 
the evidentiary hearing decision for all cases in which the State's 
enforcement action prevails.



Sec. 488.446  Administrator sanctions: long-term care facility 
closures.

    Any individual who is or was the administrator of a facility and 
fails or failed to comply with the requirements at Sec. 483.70(l) of 
this chapter--
    (a) Will be subject to a civil monetary penalty as follows:
    (1) A minimum of $500 as adjusted annually under 45 CFR part 102 for 
the first offense.
    (2) A minimum of $1,500 as adjusted annually under 45 CFR part 102 
for the second offense.
    (3) A minimum of $3,000 as adjusted annually under 45 CFR part 102 
for the third and subsequent offenses.
    (b) May be subject to exclusion from participation in any Federal 
health care program (as defined in section 1128B(f) of the Act); and
    (c) Will be subject to any other penalties that may be prescribed by 
law.

[76 FR 9511, Feb. 18, 2011, as amended at 81 FR 61563, Sept. 6, 2016; 81 
FR 68872, Oct. 4, 2016]



Sec. 488.447  Civil Money Penalties imposed for failure to comply with
42 CFR 483.80(g)(1) and (2).

    (a) CMS may impose a civil money penalty for noncompliance with the 
requirements at Sec. 483.80(g)(1) and (2) of this chapter as follows:
    (1) Minimum. A minimum of $1,000 for the first occurrence.
    (2) Increased amount. An amount equal to $500 added to the 
previously imposed civil money penalty amount for each subsequent 
occurrence, not to exceed the maximum amount set forth in Sec. 
488.408(d)(1)(iii).
    (b) The penalty amounts in this section will be adjusted annually 
under 45 CFR part 102.
    (c) Compliance with the requirements at Sec. 483.80(g)(1) and (2) 
of this chapter will be assessed weekly. Facilities found out of 
compliance with

[[Page 566]]

Sec. 483.80(g)(1) and (2) of this chapter are not required to submit a 
plan of correction as indicated in Sec. 488.408(f)(1).
    (d) This section is in effect during and the Public Health Emergency 
(PHE), as defined in Sec. 400.200 of this chapter, and will continue 
for up to one year after the end of the PHE.

[85 FR 54873, Sept. 2, 2020]



Sec. 488.450  Continuation of payments to a facility with deficiencies.

    (a) Criteria. (1) CMS may continue payments to a facility not in 
substantial compliance for the periods specified in paragraph (c) of 
this section if the following criteria are met:
    (i) The State survey agency finds that it is more appropriate to 
impose alternative remedies than to terminate the facility;
    (ii) The State has submitted a plan and timetable for corrective 
action approved by CMS; and
    (iii) The facility, in the case of a Medicare SNF, or the State, in 
the case of a Medicaid NF, agrees to repay the Federal government 
payments received under this provision if corrective action is not taken 
in accordance with the approved plan and timetable for corrective 
action.
    (2) CMS or the State may terminate the SNF or NF agreement before 
the end of the correction period if the criteria in paragraph (a)(1) of 
this section are not met.
    (b) Cessation of payments. If termination is not sought, either by 
itself or along with another remedy or remedies, or any of the criteria 
set forth in paragraph (a)(1) of this section are not met or agreed to 
by either the facility or the State, the facility or State will receive 
no Medicare or Federal Medicaid payments, as applicable, from the last 
day of the survey.
    (c) Period of continued payments--(1) Non-compliance. If the 
conditions in paragraph (a)(1) of this section are met, CMS may continue 
payments to a Medicare facility or the State for a Medicaid facility 
with noncompliance that does not constitute immediate jeopardy for up to 
6 months from the last day of the survey.
    (2) Facility closure. In the case of a facility closure, the 
Secretary may, as the Secretary determines appropriate, continue to make 
payments with respect to residents of a long-term care facility that has 
submitted a notification of closure during the period beginning on the 
date such notification is submitted to CMS and ending on the date on 
which the residents are successfully relocated.
    (d) Failure to achieve substantial compliance. If the facility does 
not achieve substantial compliance by the end of the period specified in 
paragraph (c) of this section,
    (1) CMS will--
    (i) Terminate the provider agreement of the Medicare SNF in 
accordance with Sec. 488.456; or
    (ii) Discontinue Federal funding to the SNF for Medicare; and
    (iii) Discontinue FFP to the State for the Medicaid NF.
    (2) The State may terminate the provider agreement for the NF.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
76 FR 9511, Feb. 18, 2011; 78 FR 16805, Mar. 19, 2013]



Sec. 488.452  State and Federal disagreements involving findings not
in agreement in non-State operated NFs and dually participating 
facilities when there is no immediate jeopardy.
          

    The following rules apply when CMS and the State disagree over 
findings of noncompliance or application of remedies in a non-State 
operated NF or dually participating facility:
    (a) Disagreement over whether facility has met requirements. (1) The 
State's finding of noncompliance takes precedence when--
    (i) CMS finds that a NF or a dually participating facility is in 
substantial compliance with the participation requirements; and
    (ii) The State finds that a NF or dually participating facility has 
not achieved substantial compliance.
    (2) CMS's findings of noncompliance take precedence when--
    (i) CMS finds that a NF or a dually participating facility has not 
achieved substantial compliance; and
    (ii) The State finds that a NF or a dually participating facility is 
in substantial compliance with the participation requirements.
    (3) When CMS's survey findings take precedence, CMS may--

[[Page 567]]

    (i) Impose any of the alternative remedies specified in Sec. 
488.406;
    (ii) Terminate the provider agreement subject to the applicable 
conditions of Sec. 488.450; and
    (iii) Stop FFP to the State for a NF.
    (b) Disagreement over decision to terminate. (1) CMS's decision to 
terminate the participation of a facility takes precedence when--
    (i) Both CMS and the State find that the facility has not achieved 
substantial compliance; and
    (ii) CMS, but not the State, finds that the facility's participation 
should be terminated. CMS will permit continuation of payment during the 
period prior to the effective date of termination not to exceed 6 
months, if the applicable conditions of Sec. 488.450 are met.
    (2) The State's decision to terminate a facility's participation and 
the procedures for appealing such termination, as specified in Sec. 
431.153(c) of this chapter, takes precedence when--
    (i) The State, but not CMS, finds that a NF's participation should 
be terminated; and
    (ii) The State's effective date for the termination of the NF's 
provider agreement is no later than 6 months after the last day of 
survey.
    (c) Disagreement over timing of termination of facility. The State's 
timing of termination takes precedence if it does not occur later than 6 
months after the last day of the survey when both CMS and the State find 
that--
    (1) A facility is not in substantial compliance; and
    (2) The facility's participation should be terminated.
    (d) Disagreement over remedies. (1) When CMS or the State, but not 
both, establishes one or more remedies, in addition to or as an 
alternative to termination, the additional or alternative remedies will 
also apply when--
    (i) Both CMS and the State find that a facility has not achieved 
substantial compliance; and
    (ii) Both CMS and the State find that no immediate jeopardy exists.
    (2) Overlap of remedies. When CMS and the State establish one or 
more remedies, in addition to or as an alternative to termination, only 
the CMS remedies apply when both CMS and the State find that a facility 
has not achieved substantial compliance.
    (e) Regardless of whether CMS's or the State's decision controls, 
only one noncompliance and enforcement decision is applied to the 
Medicaid agreement, and for a dually participating facility, that same 
decision will apply to the Medicare agreement.



Sec. 488.454  Duration of remedies.

    (a) Except as specified in paragraphs (b) and (d) of this section, 
alternative remedies continue until--
    (1) The facility has achieved substantial compliance, as determined 
by CMS or the State based upon a revisit or after an examination of 
credible written evidence that it can verify without an on-site visit; 
or
    (2) CMS or the State terminates the provider agreement.
    (b) In the cases of State monitoring and denial of payment imposed 
for repeated substandard quality of care, remedies continue until--
    (1) CMS or the State determines that the facility has achieved 
substantial compliance and is capable of remaining in substantial 
compliance; or
    (2) CMS or the State terminates the provider agreement.
    (c) In the case of temporary management, the remedy continues 
until--
    (1) CMS or the State determines that the facility has achieved 
substantial compliance and is capable of remaining in substantial 
compliance;
    (2) CMS or the State terminates the provider agreement; or
    (3) The facility which has not achieved substantial compliance 
reassumes management control. In this case, CMS or the State initiates 
termination of the provider agreement and may impose additional 
remedies.
    (d) In the case of a civil money penalty imposed for an instance of 
noncompliance, the remedy is the specific amount of the civil money 
penalty imposed for the particular deficiency.
    (e) If the facility can supply documentation acceptable to CMS or 
the State survey agency that it was in substantial compliance and was 
capable of remaining in substantial compliance, if necessary, on a date 
preceding that of the revisit, the remedies terminate on the date that 
CMS or the State can

[[Page 568]]

verify as the date that substantial compliance was achieved and the 
facility demonstrated that it could maintain substantial compliance, if 
necessary.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13361, Mar. 18, 1999]



Sec. 488.456  Termination of provider agreement.

    (a) Effect of termination. Termination of the provider agreement 
ends--
    (1) Payment to the facility; and
    (2) Any alternative remedy.
    (b) Basis for termination. (1) CMS and the State may terminate a 
facility's provider agreement if a facility--
    (i) Is not in substantial compliance with the requirements of 
participation, regardless of whether or not immediate jeopardy is 
present; or
    (ii) Fails to submit an acceptable plan of correction within the 
timeframe specified by CMS or the State.
    (2) CMS and the State terminate a facility's provider agreement if a 
facility--
    (i) Fails to relinquish control to the temporary manager, if that 
remedy is imposed by CMS or the State; or
    (ii) Does not meet the eligibility criteria for continuation of 
payment as set forth in Sec. 488.412(a)(1).
    (c) Notice of termination. Before terminating a provider agreement, 
CMS does and the State must notify the facility and the public--
    (1) At least 2 calendar days before the effective date of 
termination for a facility with immediate jeopardy deficiencies; and
    (2) At least 15 calendar days before the effective date of 
termination for a facility with non-immediate jeopardy deficiencies that 
constitute noncompliance.
    (d) Procedures for termination. (1) CMS terminates the provider 
agreement in accordance with procedures set forth in Sec. 489.53 of 
this chapter; and
    (2) The State must terminate the provider agreement of a NF in 
accordance with procedures specified in parts 431 and 442 of this 
chapter.

Subpart G [Reserved]



Subpart H_Termination of Medicare Coverage and Alternative Sanctions for 
                End-Stage Renal Disease (ESRD) Facilities

    Source: 73 FR 20475, Apr. 15, 2008, unless otherwise noted.



Sec. 488.604  Termination of Medicare coverage.

    (a) Except as otherwise provided in this subpart, failure of a 
supplier of ESRD services to meet one or more of the conditions for 
coverage set forth in part 494 of this chapter will result in 
termination of Medicare coverage of the services furnished by the 
supplier.
    (b) If termination of coverage is based solely on a supplier's 
failure to participate in network activities and pursue network goals, 
as required at Sec. 494.180(i) of this chapter, coverage may be 
reinstated when CMS determines that the supplier is making reasonable 
and appropriate efforts to meet that condition.
    (c) If termination of coverage is based on failure to meet any of 
the other conditions specified in part 494 of this chapter, coverage 
will not be reinstated until CMS finds that the reason for termination 
has been removed and there is reasonable assurance that it will not 
recur.



Sec. 488.606  Alternative sanctions.

    (a) Basis for application of alternative sanctions. CMS may, as an 
alternative to termination of Medicare coverage, impose one of the 
sanctions specified in paragraph (b) of this section if CMS finds that--
    (1) The supplier fails to participate in the activities and pursue 
the goals of the ESRD network that is designated to encompass the 
supplier's geographic area; and
    (2) This failure does not jeopardize patient health and safety.
    (b) Alternative sanctions. The alternative sanctions that CMS may 
apply in the circumstances specified in paragraph (a) of this section 
include the following:
    (1) Denial of payment for services furnished to patients first 
accepted for care after the effective date of the

[[Page 569]]

sanction as specified in the sanction notice.
    (2) Reduction of payments, for all ESRD services furnished by the 
supplier, by 20 percent for each 30-day period after the effective date 
of the sanction.
    (3) Withholding of all payments, without interest, for all ESRD 
services furnished by the supplier to Medicare beneficiaries.
    (c) Duration of alternative sanction. An alternative sanction 
remains in effect until CMS finds that the supplier is in substantial 
compliance with the requirement to cooperate in the network plans and 
goals, or terminates coverage of the supplier's services for lack of 
compliance.



Sec. 488.608  Notice of alternative sanction and appeal rights:
Termination of coverage.

    (a) Notice of alternative sanction. CMS gives the supplier and the 
general public notice of the alternative sanction and of the effective 
date of the sanction. The effective date of the alternative sanction is 
at least 30 days after the date of the notice.
    (b) Appeal rights. Termination of Medicare coverage of a supplier's 
ESRD services because the supplier no longer meets the conditions for 
coverage of its services is an initial determination appealable under 
part 498 of this chapter.



Sec. 488.610  Notice of appeal rights: Alternative sanctions.

    If CMS proposes to apply an alternative sanction specified in Sec. 
488.606(b), the following rules apply:
    (a) CMS gives the facility notice of the proposed alternative 
sanction and 15 days in which to request a hearing.
    (b) If the facility requests a hearing, CMS provides an informal 
hearing by a CMS official who was not involved in making the appealed 
decision.
    (c) During the informal hearing, the facility--
    (1) May be represented by counsel;
    (2) Has access to the information on which the allegation was based; 
and
    (3) May present, orally or in writing, evidence and documentation to 
refute the finding of failure to participate in network activities and 
pursue network goals.
    (d) If the written decision of the informal hearing supports 
application of the alternative sanction, CMS provides the facility and 
the public, at least 30 days before the effective date of the 
alternative sanction, a written notice that specifies the effective date 
and the reasons for the alternative sanction.



       Subpart I_Survey and Certification of Home Health Agencies

    Source: 77 FR 67164, Nov. 8, 2012, unless otherwise noted.



Sec. 488.700  Basis and scope.

    Section 1891 of the Act establishes requirements for surveying HHAs 
to determine whether they meet the Medicare conditions of participation.



Sec. 488.705  Definitions.

    As used in this subpart--
    Abbreviated standard survey means a focused survey other than a 
standard survey that gathers information on an HHA's compliance with 
fewer specific standards or conditions of participation. An abbreviated 
standard survey may be based on complaints received, a change of 
ownership or management, or other indicators of specific concern such as 
reapplication for Medicare billing privileges following a deactivation.
    Complaint survey means a survey that is conducted to investigate 
specific allegations of noncompliance.
    Condition-level deficiency means noncompliance as described in Sec. 
488.24 of this part.
    Deficiency is a violation of the Act and regulations contained in 
part 484, subparts A through C of this chapter, is determined as part of 
a survey, and can be either standard or condition-level.
    Extended survey means a survey that reviews additional conditions of 
participation not examined during a standard survey. It may be conducted 
at any time but must be conducted when substandard care is identified.
    Noncompliance means any deficiency found at the condition-level or 
standard-level.

[[Page 570]]

    Partial extended survey means a survey conducted to determine if 
deficiencies and/or deficient practice(s) exist that were not fully 
examined during the standard survey. The surveyors may review any 
additional requirements which would assist in making a compliance 
finding.
    Standard-level deficiency means noncompliance with one or more of 
the standards that make up each condition of participation for HHAs.
    Standard survey means a survey conducted in which the surveyor 
reviews the HHA's compliance with a select number of standards and/or 
conditions of participation in order to determine the quality of care 
and services furnished by an HHA as measured by indicators related to 
medical, nursing, and rehabilitative care.
    Substandard care means noncompliance with one or more conditions of 
participation identified on a standard survey, including deficiencies 
which could result in actual or potential harm to patients of an HHA.
    Substantial compliance means compliance with all condition-level 
requirements, as determined by CMS or the State.



Sec. 488.710  Standard surveys.

    (a) For each HHA, the survey agency must conduct a standard survey 
not later than 36 months after the date of the previous standard survey 
that includes, but is not limited to, all of the following (to the 
extent practicable):
    (1) A case-mix stratified sample of individuals furnished items or 
services by the HHA.
    (2) Visits to the homes of patients, (the purpose of the home visit 
is to evaluate the extent to which the quality and scope of services 
furnished by the HHA attained and maintained the highest practicable 
functional capacity of each patient as reflected in the patient's 
written plan of care and clinical records), but only with their consent, 
and, if determined necessary by CMS or the survey team, other forms of 
communication with patients including telephone calls.
    (3) Review of indicators that include the outcomes of quality care 
and services furnished by the agency as indicated by medical, nursing, 
and rehabilitative care.
    (4) Review of compliance with a select number of regulations most 
related to high-quality patient care.
    (b) The survey agency's failure to follow the procedures set forth 
in this section will not invalidate otherwise legitimate determinations 
that deficiencies exist at an HHA.



Sec. 488.715  Partial extended surveys.

    A partial extended survey is conducted to determine if standard or 
condition-level deficiencies are present in the conditions of 
participation not fully examined during the standard survey and there 
are indications that a more comprehensive review of conditions of 
participation would determine if a deficient practice exists.



Sec. 488.720  Extended surveys.

    (a) Purpose of survey. The purpose of an extended survey is:
    (1) To review and identify the policies and procedures that caused 
an HHA to furnish substandard care.
    (2) To determine whether the HHA is in compliance with one or more 
or all additional conditions of participation not examined during the 
standard survey.
    (b) Timing and basis for survey. An extended survey must be 
conducted not later than 14 calendar days after completion of a standard 
survey which found that a HHA was out of compliance with a condition of 
participation.



Sec. 488.725  Unannounced surveys.

    (a) Basic rule. All HHA surveys must be unannounced and conducted 
with procedures and scheduling that renders the onsite surveys as 
unpredictable in their timing as possible.
    (b) State survey agency's scheduling and surveying procedures. CMS 
reviews each survey agency's scheduling and surveying procedures and 
practices to assure that the survey agency has taken all reasonable 
steps to avoid giving notice of a survey through the scheduling 
procedures and conduct of the surveys.
    (c) Civil money penalties. Any individual who notifies an HHA, or 
causes an HHA to be notified, of the time or date on which a standard 
survey is

[[Page 571]]

scheduled to be conducted is subject to a Federal civil money penalty 
not to exceed $2,000 as adjusted annually under 45 CFR part 102.

[77 FR 67164, Nov. 8, 2012, as amended at 81 FR 61563, Sept. 6, 2016]



Sec. 488.730  Survey frequency and content.

    (a) Basic period. Each HHA must be surveyed not later than 36 months 
after the last day of the previous standard survey. Additionally, a 
survey may be conducted as frequently as necessary to--
    (1) Assure the delivery of quality home health services by 
determining whether an HHA complies with the Act and conditions of 
participation; and
    (2) Confirm that the HHA has corrected deficiencies that were 
previously cited.
    (b) Change in HHA information. A standard survey or an abbreviated 
standard survey may be conducted within 2 months of a change, or 
knowledge of a change, in any of the following:
    (1) Ownership;
    (2) Administration; or,
    (3) Management of the HHA.
    (c) Complaints. A standard survey, or abbreviated standard survey--
    (1) Must be conducted of an HHA within 2 months of when a 
significant number of complaints against the HHA are reported to CMS, 
the State, the State or local agency responsible for maintaining a toll-
free hotline and investigative unit, or any other appropriate Federal, 
State, or local agency; or
    (2) As otherwise required to determine compliance with the 
conditions of participation such as the investigation of a complaint.



Sec. 488.735  Surveyor qualifications.

    (a) Minimum qualifications. Surveys must be conducted by individuals 
who meet minimum qualifications prescribed by CMS. In addition, before 
any State or Federal surveyor may serve on an HHA survey team (except as 
a trainee), he/she must have successfully completed the relevant CMS-
sponsored Basic HHA Surveyor Training Course and any associated course 
prerequisites. All surveyors must follow the principles set forth in 
Sec. 488.24 through Sec. 488.28 according to CMS policies and 
procedures for determining compliance with the conditions of 
participation.
    (b) Disqualifications. Any of the following circumstances 
disqualifies a surveyor from surveying a particular agency:
    (1) The surveyor currently works for, or, within the past two years, 
has worked with the HHA to be surveyed as:
    (i) A direct employee;
    (ii) An employment agency staff at the agency; or
    (iii) An officer, consultant, or agent for the agency to be surveyed 
concerning compliance with conditions of participation specified in or 
pursuant to sections 1861(o) or 1891(a) of the Act.
    (2) The surveyor has a financial interest or an ownership interest 
in the HHA to be surveyed.
    (3) The surveyor has a family member who has a relationship with the 
HHA to be surveyed.
    (4) The surveyor has an immediate family member who is a patient of 
the HHA to be surveyed.



Sec. 488.740  Certification of compliance or noncompliance.

    Rules to be followed for certification, documentation of findings, 
periodic review of compliance and approval, certification of 
noncompliance, and determining compliance of HHAs are set forth, 
respectively, in Sec. Sec. 488.12, 488.18, 488.20, 488.24, and 488.26 
of this part.



Sec. 488.745  Informal Dispute Resolution (IDR).

    (a) Opportunity to refute survey findings. Upon the provider's 
receipt of an official statement of deficiencies, HHAs are afforded the 
option to request an informal opportunity to dispute condition-level 
survey findings.
    (b) Failure to conduct IDR timely. Failure of CMS or the State, as 
appropriate, to complete IDR shall not delay the effective date of any 
enforcement action.
    (c) Revised statement of deficiencies as a result of IDR. If any 
findings are revised or removed by CMS or the State based on IDR, the 
official statement of deficiencies is revised accordingly and

[[Page 572]]

any enforcement actions imposed solely as a result of those cited 
deficiencies are adjusted accordingly.
    (d) Notification. When the survey findings indicate a condition-
level deficiency, CMS or the State, as appropriate, must provide the 
agency with written notification of the opportunity for participating in 
an IDR process at the time the official statement of deficiencies is 
issued. The request for IDR must be submitted in writing to the State or 
CMS, must include the specific deficiencies that are disputed, and must 
be made within the same 10 calendar day period that the HHA has for 
submitting an acceptable plan of correction.



     Subpart J_Alternative Sanctions for Home Health Agencies With 
                              Deficiencies

    Source: 77 FR 67165, Nov. 8, 2012, unless otherwise noted.



Sec. 488.800  Statutory basis.

    Section 1891(e) through (f) of the Act authorizes the Secretary to 
take actions to remove and correct deficiencies in an HHA through an 
alternative sanction or termination or both. Furthermore, this section 
specifies that these sanctions are in addition to any others available 
under State or Federal law, and, except for the final determination of 
civil money penalties, are imposed prior to the conduct of a hearing.



Sec. 488.805  Definitions.

    As used in this subpart--
    Directed plan of correction means CMS or the temporary manager (with 
CMS/SA approval) may direct the HHA to take specific corrective action 
to achieve specific outcomes within specific timeframes.
    Immediate jeopardy means a situation in which the provider's 
noncompliance with one or more requirements of participation has caused, 
or is likely to cause serious injury, harm, impairment, or death to a 
patient(s).
    New admission means an individual who becomes a patient or is 
readmitted to the HHA on or after the effective date of a suspension of 
payment sanction.
    Per instance means a single event of noncompliance identified and 
corrected through a survey, for which the statute authorizes CMS to 
impose a sanction.
    Plan of correction means a plan developed by the HHA and approved by 
CMS that is the HHA's written response to survey findings detailing 
corrective actions to cited deficiencies and specifies the date by which 
those deficiencies will be corrected.
    Repeat deficiency means a condition-level citation that is cited on 
the current survey and is substantially the same as or similar to, a 
finding of a standard-level or condition-level deficiency citation cited 
on the most recent previous standard survey or on any intervening survey 
since the most recent standard survey.
    Temporary management means the temporary appointment by CMS or by a 
CMS authorized agent, of a substitute manager or administrator based 
upon qualifications described in Sec. Sec. 484.105(b) and 484.115 of 
this chapter. The HHA's governing body must ensure that the temporary 
manager has authority to hire, terminate or reassign staff, obligate 
funds, alter procedures, and manage the HHA to correct deficiencies 
identified in the HHA's operation.

[77 FR 67165, Nov. 8, 2012, as amended at 82 FR 4591, Jan. 13, 2017]



Sec. 488.810  General provisions.

    (a) Purpose of sanctions. The purpose of sanctions is to ensure 
prompt compliance with program requirements in order to protect the 
health and safety of individuals under the care of an HHA.
    (b) Basis for imposition of sanctions. When CMS chooses to apply one 
or more sanctions specified in Sec. 488.820, the sanctions are applied 
on the basis of noncompliance with one or more conditions of 
participation found through a survey and may be based on failure to 
correct previous deficiency findings as evidenced by repeat 
deficiencies.
    (c) Number of sanctions. CMS may apply one or more sanctions for 
each deficiency constituting noncompliance

[[Page 573]]

or for all deficiencies constituting noncompliance.
    (d) Extent of sanctions imposed. When CMS imposes a sanction, the 
sanction applies to the parent HHA and its respective branch offices.
    (e) Plan of correction requirement. Regardless of which sanction is 
applied, a non-compliant HHA must submit a plan of correction for 
approval by CMS.
    (f) Notification requirements--(1) Notice. CMS provides written 
notification to the HHA of the intent to impose the sanction.
    (2) Date of enforcement action. The notice periods specified in 
Sec. 488.825(b) and Sec. 488.830(b) begin the day after the HHA 
receives the notice.
    (g) Appeals. (1) The provisions of part 498 of this chapter apply 
when the HHA requests a hearing on a determination of noncompliance 
leading to the imposition of a sanction, including termination of the 
provider agreement.
    (2) A pending hearing does not delay the effective date of a 
sanction, including termination, against an HHA. Sanctions continue to 
be in effect regardless of the timing of any appeals proceedings.



Sec. 488.815  Factors to be considered in selecting sanctions.

    CMS bases its choice of sanction or sanctions on consideration of 
one or more factors that include, but are not limited to, the following:
    (a) The extent to which the deficiencies pose immediate jeopardy to 
patient health and safety.
    (b) The nature, incidence, manner, degree, and duration of the 
deficiencies or noncompliance.
    (c) The presence of repeat deficiencies, the HHA's overall 
compliance history and any history of repeat deficiencies at either the 
parent or branch location.
    (d) The extent to which the deficiencies are directly related to a 
failure to provide quality patient care.
    (e) The extent to which the HHA is part of a larger organization 
with performance problems.
    (f) An indication of any system-wide failure to provide quality 
care.



Sec. 488.820  Available sanctions.

    In addition to termination of the provider agreement, the following 
alternative sanctions are available:
    (a) Civil money penalties.
    (b) Suspension of payment for all new admissions.
    (c) Temporary management of the HHA.
    (d) Directed plan of correction, as set out at Sec. 488.850.
    (e) Directed in-service training, as set out at Sec. 488.855.



Sec. 488.825  Action when deficiencies pose immediate jeopardy.

    (a) Immediate jeopardy. If there is immediate jeopardy to the HHA's 
patient health or safety--
    (1) CMS immediately terminates the HHA provider agreement in 
accordance with Sec. 489.53 of this chapter.
    (2) CMS terminates the HHA provider agreement no later than 23 days 
from the last day of the survey, if the immediate jeopardy has not been 
removed by the HHA.
    (3) In addition to a termination, CMS may impose one or more 
alternative sanctions, as appropriate.
    (b) 2-day notice. Except for civil money penalties, for all 
sanctions specified in Sec. 488.820 that are imposed when there is 
immediate jeopardy, notice must be given at least 2 calendar days before 
the effective date of the enforcement action.
    (c) Transfer of care. An HHA, if its provider agreement terminated, 
is responsible for providing information, assistance, and arrangements 
necessary for the proper and safe transfer of patients to another local 
HHA within 30 days of termination. The State must assist the HHA in the 
safe and orderly transfer of care and services for the patients to 
another local HHA.



Sec. 488.830  Action when deficiencies are at the condition-level but
do not pose immediate jeopardy.

    (a) Noncompliance. If the HHA is no longer in compliance with the 
conditions of participation, either because the deficiency or 
deficiencies substantially limit the provider's capacity to furnish 
adequate care but do not pose immediate jeopardy, have a condition-level 
deficiency or deficiencies that do

[[Page 574]]

not pose immediate jeopardy, or because the HHA has repeat noncompliance 
that results in a condition-level deficiency based on the HHA's failure 
to correct and sustain compliance, CMS will:
    (1) Terminate the HHA's provider agreement; or
    (2) Impose one or more alternative sanctions set forth in Sec. 
488.820(a) through (f) of this part as an alternative to termination, 
for a period not to exceed 6 months.
    (b) 15-day notice. Except for civil money penalties, for all 
sanctions specified in Sec. 488.820 imposed when there is no immediate 
jeopardy, notice must be given at least 15 calendar days before the 
effective date of the enforcement action. The requirements of the notice 
are set forth in Sec. 488.810(f) of this part.
    (c) Not meeting criteria for continuation of payment. If an HHA does 
not meet the criteria for continuation of payment under Sec. 488.860(a) 
of this part, CMS will terminate the HHA's provider agreement in 
accordance with Sec. 488.865 of this part.
    (d) Termination time frame when there is no immediate jeopardy. CMS 
terminates an HHA within 6 months of the last day of the survey, if the 
HHA is not in compliance with the conditions of participation, and the 
terms of the plan of correction have not been met.
    (e) Transfer of care. An HHA, if its provider agreement terminated, 
is responsible for providing information, assistance, and arrangements 
necessary for the proper and safe transfer of patients to another local 
HHA within 30 days of termination. The State must assist the HHA in the 
safe and orderly transfer of care and services for the patients to 
another local HHA.



Sec. 488.835  Temporary management.

    (a) Application. (1) CMS may impose temporary management of an HHA 
if it determines that an HHA has a condition-level noncompliance and CMS 
determines that management limitations or the deficiencies are likely to 
impair the HHA's ability to correct deficiencies and return the HHA to 
full compliance with the conditions of participation within the 
timeframe required.
    (2) [Reserved]
    (b) Procedures. (1) CMS notifies the HHA that a temporary manager is 
being appointed.
    (2) If the HHA fails to relinquish authority and control to the 
temporary manager, CMS terminates the HHA's provider agreement in 
accordance with Sec. 488.865.
    (c) Duration and effect of sanction. Temporary management continues 
until--
    (1) CMS determines that the HHA has achieved substantial compliance 
and has the management capability to ensure continued compliance with 
all the conditions of participation;
    (2) CMS terminates the provider agreement; or
    (3) The HHA reassumes management control without CMS approval. In 
such case, CMS initiates termination of the provider agreement and may 
impose additional sanctions.
    (4) Temporary management will not exceed a period of 6 months from 
the date of the survey identifying noncompliance.
    (d) Payment of salary. (1) The temporary manager's salary--
    (i) Is paid directly by the HHA while the temporary manager is 
assigned to that HHA; and
    (ii) Must be at least equivalent to the sum of the following:
    (A) The prevailing salary paid by providers for positions of this 
type in what the State considers to be the HHA's geographic area 
(prevailing salary based on the Geographic Guide by the Department of 
Labor (BLS Wage Data by Area and Occupation);
    (B) Any additional costs that would have reasonably been incurred by 
the HHA if such person had been in an employment relationship; and
    (C) Any other costs incurred by such a person in furnishing services 
under such an arrangement or as otherwise set by the State.
    (2) An HHA's failure to pay the salary and other costs of the 
temporary manager described in paragraph (d)(1) of this section is 
considered a failure to relinquish authority and control to temporary 
management.

[[Page 575]]



Sec. 488.840  Suspension of payment for all new patient admissions.

    (a) Application. (1) CMS may suspend payment for all new admissions 
if an HHA is found to have condition-level deficiencies, regardless of 
whether those deficiencies pose immediate jeopardy.
    (2) CMS will consider this sanction for any deficiency related to 
poor patient care outcomes, regardless of whether the deficiency poses 
immediate jeopardy.
    (b) Procedures--(1) Notices. (i) Before suspending payments for new 
admissions, CMS provides the HHA notice of the suspension of payment for 
all new admissions as set forth in Sec. 488.810(f). The CMS notice of 
suspension will include the nature of the noncompliance; the effective 
date of the sanction; and the right to appeal the determination leading 
to the sanction.
    (ii) The HHA may not charge a newly admitted HHA patient who is a 
Medicare beneficiary for services for which Medicare payment is 
suspended unless the HHA can show that, before initiating care, it gave 
the patient or his or her representative oral and written notice of the 
suspension of Medicare payment in a language and manner that the 
beneficiary or representative can understand.
    (2) Restriction. (i) Suspension of payment for all new admissions 
sanction may be imposed anytime an HHA is found to be out of substantial 
compliance.
    (ii) Suspension of payment for patients with new admissions will 
remain in place until CMS determines that the HHA has achieved 
substantial compliance or is involuntarily terminated with the 
conditions of participation, as determined by CMS.
    (3) Resumption of payments. Payments to the HHA resume prospectively 
on the date that CMS determines that the HHA has achieved substantial 
compliance with the conditions of participation.
    (c) Duration and effect of sanction. This sanction ends when--
    (1) CMS determines that the HHA is in substantial compliance with 
all of the conditions of participation; or
    (2) When the HHA is terminated or CMS determines that the HHA is not 
in compliance with the conditions of participation at a maximum of 6 
months from the date noncompliance was determined.



Sec. 488.845  Civil money penalties.

    (a) Application. (1) CMS may impose a civil money penalty against an 
HHA for either the number of days the HHA is not in compliance with one 
or more conditions of participation or for each instance that an HHA is 
not in compliance, regardless of whether the HHA's deficiencies pose 
immediate jeopardy.
    (2) CMS may impose a civil money penalty for the number of days of 
immediate jeopardy.
    (3) A per-day and a per-instance CMP may not be imposed 
simultaneously for the same deficiency.
    (b) Amount of penalty--(1) Factors considered. CMS takes into 
account the following factors in determining the amount of the penalty:
    (i) The factors set out at Sec. 488.815.
    (ii) The size of an agency and its resources.
    (iii) Accurate and credible resources, such as PECOS, Medicare cost 
reports and Medicare/Medicaid claims information that provide 
information on the operation and resources of the HHA.
    (iv) Evidence that the HHA has a built-in, self-regulating quality 
assessment and performance improvement system to provide proper care, 
prevent poor outcomes, control patient injury, enhance quality, promote 
safety, and avoid risks to patients on a sustainable basis that 
indicates the ability to meet the conditions of participation and to 
ensure patient health and safety.
    (2) Adjustments to penalties. Based on revisit survey findings, 
adjustments to penalties may be made after a review of the provider's 
attempted correction of deficiencies.
    (i) CMS may increase a CMP in increments based on a HHA's inability 
or failure to correct deficiencies, the presence of a system-wide 
failure in the provision of quality care, or a determination of 
immediate jeopardy with actual harm versus immediate jeopardy with 
potential for harm.
    (ii) CMS may also decrease a CMP in increments to the extent that it 
finds, pursuant to a revisit, that substantial and sustainable 
improvements have

[[Page 576]]

been implemented even though the HHA is not yet in full compliance with 
the conditions of participation.
    (iii) No penalty assessment will exceed $10,000 as adjusted annually 
under 45 CFR part 102 for each day of noncompliance.
    (3) Upper range of penalty. Penalties in the upper range of $8,500 
to $10,000 as adjusted under 45 CFR part 102 per day of noncompliance 
are imposed for a condition-level deficiency that is immediate jeopardy. 
The penalty in this range will continue until compliance can be 
determined based on a revisit survey.
    (i) $10,000 as adjusted annually under 45 CFR part 102 per day for a 
deficiency or deficiencies that are immediate jeopardy and that result 
in actual harm.
    (ii) $9,000 as adjusted annually under 45 CFR part 102 per day for a 
deficiency or deficiencies that are immediate jeopardy and that result 
in a potential for harm.
    (iii) $8,500 as adjusted annually under 45 CFR part 102 per day for 
an isolated incident of noncompliance in violation of established HHA 
policy.
    (4) Middle range of penalty. Penalties in the range of $1,500-$8,500 
as adjusted annually under 45 CFR part 102 per day of noncompliance are 
imposed for a repeat and/or condition-level deficiency that does not 
constitute immediate jeopardy, but is directly related to poor quality 
patient care outcomes.
    (5) Lower range of penalty. Penalties in this range of $500-$4,000 
as adjusted annually under 45 CFR part 102 are imposed for a repeat and/
or condition-level deficiency that does not constitute immediate 
jeopardy and that are related predominately to structure or process-
oriented conditions (such as OASIS submission requirements) rather than 
directly related to patient care outcomes.
    (6) Per instance penalty. Penalty imposed per instance of 
noncompliance may be assessed for one or more singular events of 
condition-level noncompliance that are identified and where the 
noncompliance was corrected during the onsite survey. When penalties are 
imposed for per instance of noncompliance, or more than one per instance 
of noncompliance, the penalties will be in the range of $1,000 to 
$10,000 as adjusted annually under 45 CFR part 102 per instance, not to 
exceed $10,000 as adjusted annually under 45 CFR part 102 each day of 
noncompliance.
    (7) Decreased penalty amounts. If the immediate jeopardy situation 
is removed, but condition-level noncompliance continues, CMS will shift 
the penalty amount imposed per day from the upper range to the middle or 
lower range. An earnest effort to correct any systemic causes of 
deficiencies and sustain improvement must be evident.
    (8) Increased penalty amounts. (i) In accordance with paragraph 
(b)(2) of this section, CMS will increase the per day penalty amount for 
any condition-level deficiency or deficiencies which, after imposition 
of a lower-level penalty amount, become sufficiently serious to pose 
potential harm or immediate jeopardy.
    (ii) CMS increases the per day penalty amount for deficiencies that 
are not corrected and found again at the time of revisit survey(s) for 
which a lower-level penalty amount was previously imposed.
    (iii) CMS may impose a more severe amount of penalties for repeated 
noncompliance with the same condition-level deficiency or uncorrected 
deficiencies from a prior survey.
    (c) Procedures--(1) Notice of intent. CMS provides the HHA with 
written notice of the intent to impose a civil money penalty. The notice 
includes the amount of the CMP being imposed, the basis for such 
imposition and the proposed effective date of the sanction.
    (2) Appeals. (i) Appeals procedures. An HHA may request a hearing on 
the determination of the noncompliance that is the basis for imposition 
of the civil money penalty. The request must meet the requirements in 
Sec. 498.40 of this chapter.
    (ii) Waiver of a hearing. An HHA may waive the right to a hearing, 
in writing, within 60 days from the date of the notice imposing the 
civil money penalty. If an HHA timely waives its right to a hearing, CMS 
reduces the penalty amount by 35 percent, and the amount is due within 
15 days of the HHAs agreeing in writing to waive the hearing. If the HHA 
does not waive its right

[[Page 577]]

to a hearing in accordance to the procedures specified in this 
subsection, the civil money penalty is not reduced by 35 percent.
    (d) Accrual and duration of penalty. (1)(i) The per day civil money 
penalty may start accruing as early as the beginning of the last day of 
the survey that determines that the HHA was out of compliance, as 
determined by CMS.
    (ii) A civil money penalty for each per instance of noncompliance is 
imposed in a specific amount for that particular deficiency, with a 
maximum of $10,000 as adjusted annually under 45 CFR part 102 per day 
per HHA.
    (2) A penalty that is imposed per day and per instance of 
noncompliance may not be imposed simultaneously.
    (3) Duration of per day penalty when there is immediate jeopardy. 
(i) In the case of noncompliance that poses immediate jeopardy, CMS must 
terminate the provider agreement within 23 calendar days after the last 
day of the survey if the immediate jeopardy is not removed.
    (ii) A penalty imposed per day of noncompliance will stop accruing 
on the day the provider agreement is terminated or the HHA achieves 
substantial compliance, whichever occurs first.
    (4) Duration of penalty when there is no immediate jeopardy. (i) In 
the case of noncompliance that does not pose immediate jeopardy, the 
daily accrual of per day civil money penalties is imposed for the days 
of noncompliance prior to the notice specified in paragraph (c)(1) of 
this section and an additional period of no longer than 6 months 
following the last day of the survey.
    (ii) If the HHA has not achieved compliance with the conditions of 
participation, CMS terminates the provider agreement. The accrual of 
civil money penalty stops on the day the HHA agreement is terminated or 
the HHA achieves substantial compliance, whichever is earlier.
    (e) Computation and notice of total penalty amount. (1) When a civil 
money penalty is imposed on a per day basis and the HHA achieves 
compliance with the conditions of participation as determined by a 
revisit survey, CMS sends a final notice to the HHA containing all of 
the following information:
    (i) The amount of penalty assessed per day.
    (ii) The total number of days of noncompliance.
    (iii) The total amount due.
    (iv) The due date of the penalty.
    (v) The rate of interest to be assessed on any unpaid balance 
beginning on the due date, as provided in paragraph (f)(4) of this 
section.
    (2) When a civil money penalty is imposed for per instance of 
noncompliance, CMS sends a notice to the HHA containing all of the 
following information:
    (i) The amount of the penalty that was assessed.
    (ii) The total amount due.
    (iii) The due date of the penalty.
    (iv) The rate of interest to be assessed on any unpaid balance 
beginning on the due date, as provided in paragraph (f)(6) of this 
section.
    (3) In the case of an HHA for which the provider agreement has been 
involuntarily terminated and for which a civil money penalty was imposed 
on a per day basis, CMS sends this penalty information after one of the 
following actions has occurred:
    (i) Final administrative decision is made.
    (ii) The HHA has waived its right to a hearing in accordance with 
paragraph (c)(2)(ii) of this section.
    (iii) Time for requesting a hearing has expired and CMS has not 
received a hearing request from the HHA.
    (f) Due date for payment of penalty. A penalty is due and payable 15 
days from notice of the final administrative decision.
    (1) Payments are due for all civil money penalties within 15 days:
    (i) After a final administrative decision when the HHA achieves 
substantial compliance before the final decision or the effective date 
of termination before final decision,
    (ii) After the time to appeal has expired and the HHA does not 
appeal or fails to timely appeal the initial determination,
    (iii) After CMS receives a written request from the HHA requesting 
to

[[Page 578]]

waive its right to appeal the determinations that led to the imposition 
of a sanction,
    (iv) After substantial compliance is achieved, or
    (v) After the effective date of termination.
    (2) A request for hearing does not delay the imposition of any 
penalty; it only potentially delays the collection of the final penalty 
amount.
    (3) If an HHA waives its right to a hearing according to paragraph 
(c)(2)(ii) of this section, CMS will apply a 35 percent reduction to the 
CMP amount when:
    (i) The HHA achieved compliance with the conditions of participation 
before CMS received the written waiver of hearing; or
    (ii) The effective date of termination occurs before CMS received 
the written waiver of hearing.
    (4) The period of noncompliance may not extend beyond 6 months from 
the last day of the survey.
    (5) The amount of the penalty, when determined, may be deducted 
(offset) from any sum then or later owing by CMS or State Medicaid to 
the HHA.
    (6) Interest is assessed and accrues on the unpaid balance of a 
penalty, beginning on the due date. Interest is computed at the rate 
specified in Sec. 405.378(d) of this chapter.
    (g) Penalties collected by CMS--(1) Disbursement of CMPs. Civil 
money penalties and any corresponding interest collected by CMS from 
Medicare and Medicaid participating HHAs are disbursed in proportion to 
average dollars spent by Medicare and Medicaid at the national level 
based on MSIS and HHA PPS data for a three year fiscal period.
    (i) Based on expenditures for the FY 2007-2009 period, the initial 
proportions to be disbursed are 63 percent returned to the U.S. Treasury 
and 37 percent returned to the State Medicaid agency.
    (ii) Beginning one year after the effective date of this section, 
CMS shall annually update these proportions based on the most recent 3-
year fiscal period, prior to the year in which the CMP is imposed, for 
which CMS determines that the relevant data are essentially complete.
    (iii) The portion corresponding to the Medicare payments is returned 
to the U.S. Department of Treasury as miscellaneous receipts.
    (iv) The portion corresponding to the Medicaid payments is returned 
to the State Medicaid agency.
    (2) Penalties may not be used for Survey and Certification 
operations nor as the State's Medicaid non-Federal medical assistance or 
administrative match.
    (h) Review of the penalty. When an administrative law judge or state 
hearing officer (or higher administrative review authority) finds that 
the basis for imposing a civil monetary penalty exists, as specified in 
this part, the administrative law judge, State hearing officer (or 
higher administrative review authority) may not--
    (1) Set a penalty of zero or reduce a penalty to zero;
    (2) Review the exercise of discretion by CMS to impose a civil 
monetary penalty; and
    (3) Consider any factors in reviewing the amount of the penalty 
other than those specified in paragraph (b) of this section.

[77 FR 67165, Nov. 8, 2012, as amended at 79 FR 66118, Nov. 6, 2014; 81 
FR 61563, Sept. 6, 2016]



Sec. 488.850  Directed plan of correction.

    (a) Application. CMS may impose a directed plan of correction when 
an HHA:
    (1) Has one or more deficiencies that warrant directing the HHA to 
take specific actions; or
    (2) Fails to submit an acceptable plan of correction.
    (b) Procedures. (1) Before imposing this sanction, CMS provides the 
HHA notice of the impending sanction.
    (2) CMS or the temporary manager (with CMS approval) may direct the 
HHA to take corrective action to achieve specific outcomes within 
specific timeframes.
    (c) Duration and effect of sanction. If the HHA fails to achieve 
compliance with the conditions of participation within the timeframes 
specified in the directed plan of correction, CMS:
    (1) May impose one or more other sanctions set forth in Sec. 
488.820; or
    (2) Terminates the provider agreement.

[[Page 579]]



Sec. 488.855  Directed in-service training.

    (a) Application. CMS may require the staff of an HHA to attend in-
service training program(s) if CMS determines that--
    (1) The HHA has deficiencies that indicate noncompliance;
    (2) Education is likely to correct the deficiencies; and
    (3) The programs are conducted by established centers of health 
education and training or consultants with background in education and 
training with Medicare Home Health Providers, or as deemed acceptable by 
CMS and/or the State (by review of a copy of curriculum vitas and/or 
resumes/references to determine the educator's qualifications).
    (b) Procedures--(1) Action following training. After the HHA staff 
has received in-service training, if the HHA has not achieved 
compliance, CMS may impose one or more other sanctions specified in 
Sec. 488.820.
    (2) Payment. The HHA pays for the directed in-service training for 
its staff.



Sec. 488.860  Continuation of payments to an HHA with deficiencies.

    (a) Continued payments. CMS may continue payments to an HHA with 
condition-level deficiencies that do not constitute immediate jeopardy 
for up to 6 months from the last day of the survey if the criteria in 
paragraph (a)(1) of this section are met.
    (1) Criteria. CMS may continue payments to an HHA not in compliance 
with the conditions of participation for the period specified in 
paragraph (a) of this section if all of the following criteria are met:
    (i) The HHA has been imposed an alternative sanction or sanctions 
and termination has not been imposed.
    (ii) The HHA has submitted a plan of correction approved by CMS.
    (iii) The HHA agrees to repay the Federal government payments 
received under this provision if corrective action is not taken in 
accordance with the approved plan and timetable for corrective action.
    (2) CMS may terminate the HHA's provider agreement any time if the 
criteria in paragraph (a)(1) of this section are not met.
    (b) Cessation of payments for new admissions. If termination is 
imposed, either on its own or in addition to an alternative sanction or 
sanctions, or if any of the criteria set forth in paragraph (a)(1) of 
this section are not met, the HHA will receive no Medicare payments, as 
applicable, for new admissions following the last day of the survey.
    (c) Failure to achieve compliance with the conditions of 
participation. If the HHA does not achieve compliance with the 
conditions of participation by the end of the period specified in 
paragraph (a) of this section, CMS will terminate the provider agreement 
of the HHA in accordance with Sec. 488.865.



Sec. 488.865  Termination of provider agreement.

    (a) Effect of termination by CMS. Termination of the provider 
agreement ends--
    (1) Payment to the HHA; and
    (2) Any alternative sanction(s).
    (b) Basis for termination. CMS terminates an HHA's provider 
agreement under any one of the following conditions--
    (1) The HHA is not in compliance with the conditions of 
participation.
    (2) The HHA fails to submit an acceptable plan of correction within 
the timeframe specified by CMS.
    (3) The HHA fails to relinquish control to the temporary manager, if 
that sanction is imposed by CMS.
    (4) The HHA fails to meet the eligibility criteria for continuation 
of payment as set forth in Sec. 488.860(a)(1).
    (c) Notice. CMS notifies the HHA and the public of the termination, 
in accordance with procedures set forth in Sec. 489.53 of this chapter.
    (d) Procedures for termination. CMS terminates the provider 
agreement in accordance with procedures set forth in Sec. 489.53 of 
this chapter.
    (e) Appeal. An HHA may appeal the termination of its provider 
agreement by CMS in accordance with part 498 of this chapter.

Subpart K--[Reserved]

[[Page 580]]



       Subpart L_Accreditation of Home Infusion Therapy Suppliers

    Source: 83 FR 56631, Nov. 13, 2018, unless otherwise noted.

                           General Provisions



Sec. 488.1000  Basis and scope.

    (a) Regulatory basis for home infusion therapy services. The home 
infusion therapy health and safety regulations are codified at part 486, 
subpart I, of this chapter.
    (b) Statutory basis for the accreditation of home infusion therapy 
suppliers. (1) Sections 1102 and 1871 of the Act require that the 
Secretary prescribe such regulations as may be necessary to carry out 
the administration of the Medicare program.
    (2) Section 1834(u)(5) of the Act require the Secretary to designate 
and approve independent organizations for the purposes of accrediting 
qualified home infusion therapy suppliers.
    (c) Scope. This subpart sets forth the following:
    (1) Application and reapplication procedures for national 
accrediting organizations seeking approval or re-approval of authority 
to accredit qualified home infusion therapy suppliers.
    (2) Ongoing CMS oversight processes for approved accrediting 
organizations that accredit qualified home infusion therapy suppliers.
    (3) Appeal procedures for accrediting organizations that accredit 
qualified home infusion therapy suppliers.



Sec. 488.1005  Definitions.

    As used in this subpart--
    Immediate jeopardy means a situation in which the provider's or 
supplier's non-compliance with one or more Medicare accreditation 
requirements has caused, or is likely to cause, serious injury, harm, 
impairment, or death to a patient.
    National accrediting organization means an organization that 
accredits provider or supplier entities under a specific program and 
whose accredited provider or supplier entities under each program are 
widely dispersed geographically across the United States. In addition, 
the specific program is active, fully implemented, and operational.
    National in scope means a program is fully implemented, operational, 
and widely dispersed geographically throughout the country.
    Qualified home infusion therapy supplier means a supplier of home 
infusion therapy that meets the all of the following criteria which are 
set forth at section 1861(iii)(3)(D)(i) of the Act:
    (1) Furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs.
    (2) Ensures the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
    (3) Is accredited by an organization designated by the Secretary in 
accordance with section 1834(u)(5) of the Act.
    (4) Meets such other requirements as the Secretary determines 
appropriate.
    Reasonable assurance means an accrediting organization has 
demonstrated to CMS' satisfaction that its accreditation program 
requirements meet or exceed the Medicare program requirements.
    Rural area as defined at section 1886(d)(2)(D) of the Act.
    Substantial allegation of non-compliance means a complaint from any 
of a variety of sources (such as patient, relative, or third party), 
including complaints submitted in person, by telephone, through written 
correspondence, or in the newspaper, magazine articles or other media, 
that would, if found to be present, adversely affect the health and 
safety of patients and raises doubts as to a qualified home infusion 
therapy supplier's compliance with the applicable Medicare accreditation 
requirements.

  Approval and Oversight of Home Infusion Therapy Supplier Accrediting 
                              Organizations



Sec. 488.1010  Application and reapplication procedures for national 
home infusion therapy accrediting organizations.

    (a) Information submitted with application. A national home infusion 
therapy accrediting organization applying to CMS for approval or re-
approval of a

[[Page 581]]

designated home infusion therapy accreditation program must furnish CMS 
with information and materials that demonstrate that its home infusion 
therapy accreditation program requirements meet or exceed the applicable 
Medicare requirements for accrediting organizations, including the 
following:
    (1) Documentation that demonstrates the organization meets the 
definition of a national accrediting organization under Sec. 488.1005 
as it relates to the accreditation program.
    (2) The Medicare provider or supplier type for which the 
organization is requesting approval or reapproval.
    (3) Documentation that demonstrates the home infusion therapy 
accrediting organization's ability to take into account the capacities 
of rural home infusion therapy suppliers (as required by section 
1834(u)(5)(A)(ii) of the Act).
    (4) Information that demonstrates the home infusion therapy 
accrediting organization's knowledge, expertise, and experience in home 
infusion therapy.
    (5) A detailed crosswalk (in table format) that identifies, for each 
of the applicable Medicare requirements, the exact language of the 
organization's comparable accreditation requirements and standards.
    (6) A detailed description of the home infusion therapy accrediting 
organization's survey processes to confirm that a home infusion therapy 
supplier's processes are comparable to those of Medicare. This 
description must include all of the following:
    (i) The types and frequency of surveys performed, and a rationale 
for which accreditation requirements will be evaluated via onsite 
surveys and which will be evaluated via offsite audits, or other 
strategies for ensuring accredited home infusion therapy suppliers 
maintain adherence to the home infusion therapy accreditation program 
requirements, including an explanation of how the accrediting 
organization will maintain the schedule it proposes.
    (ii) Copies of the home infusion therapy accrediting organizations 
survey and audit forms, guidelines, and instructions to surveyors.
    (iii) Documentation demonstrating that the home infusion therapy 
accrediting organization's onsite survey or offsite audit reports 
identify, for each finding of non-compliance with accreditation 
standards, the comparable Medicare home infusion therapy accreditation 
requirements, as applicable.
    (iv) A description of the home infusion therapy accrediting 
organization's accreditation survey review process.
    (v) A description of the home infusion therapy accrediting 
organization's procedures and timelines for notifying a surveyed or 
audited home infusion therapy supplier of non-compliance with the home 
infusion therapy accreditation program's standards.
    (vi) A description of the home infusion therapy accrediting 
organization's procedures and timelines for monitoring the home infusion 
therapy supplier's correction of identified non-compliance with the 
accreditation program's standards.
    (vii) The ability of the home infusion therapy accrediting 
organization to conduct timely reviews of accreditation applications.
    (viii) A statement acknowledging that, as a condition for CMS 
approval of a national accrediting organization's accreditation program, 
the home infusion therapy accrediting organization agrees to provide CMS 
with information extracted from each home infusion therapy accreditation 
onsite survey, offsite audit or other evaluation strategies as part of 
its data submissions required under paragraph (a)(19) of this section, 
and, upon request from CMS, a copy of the most recent accreditation 
onsite survey, offsite audit, or other evaluation strategy together with 
any other information related to the survey as CMS may require 
(including corrective action plans).
    (ix) A statement acknowledging that the home infusion therapy 
accrediting organization will provide timely notification to CMS when an 
accreditation survey or complaint investigation identifies an immediate 
jeopardy as that term is defined at Sec. 488.1005. Using the format 
specified by CMS, the home infusion therapy accrediting organization 
must notify CMS within 2 business days from the date the accrediting 
organization identifies the immediate jeopardy.
    (7) Procedures to ensure that--

[[Page 582]]

    (i) Unannounced onsite surveys, as appropriate, will be conducted 
periodically, including procedures that protect against unannounced 
surveys becoming known to the provider or supplier in advance of the 
visit; or
    (ii) Offsite survey audits are performed to evaluate the quality of 
services provided which may be followed up with periodic onsite visits.
    (8) The criteria for determining the size and composition of the 
home infusion therapy accrediting organization's survey, audit and other 
evaluation strategy teams for individual supplier onsite surveys. The 
home infusion therapy accrediting organization's criteria should 
include, but not be limited to the following information:
    (i) The expected number of individual home infusion therapy supplier 
locations to be surveyed using an onsite survey.
    (ii) The number of home infusion therapy suppliers to be surveyed 
using off-site audits.
    (iii) A description of other types of home infusion therapy 
accreditation review activities to be used.
    (iv) The reasons for each type of survey (that is, initial 
accreditation survey, reaccreditation survey, and complaint survey).
    (9) The overall adequacy of the number of the home infusion therapy 
accrediting organization's surveyors, auditors, and other staff 
available to perform survey related activities, including how the 
organization will increase the size of the survey, audit, and other 
evaluation staff to match growth in the number of accredited facilities 
or programs while maintaining re-accreditation intervals for existing 
accredited facilities or programs.
    (10) Detailed information about the individuals who perform onsite 
surveys, offsite audits or other strategies for ensuring accredited home 
infusion therapy suppliers maintain adherence to the home infusion 
therapy accreditation program requirements, including all of the 
following information:
    (i) The number and types of professional and technical staff 
available for conducting onsite surveys, offsite audits, or other 
strategies for ensuring accredited home infusion therapy suppliers 
maintain adherence to the home infusion therapy accreditation program 
requirements.
    (ii) The education, employment, and experience requirements 
surveyors and auditors must meet.
    (iii) The content and length of the orientation program.
    (11) The content, frequency and types of in-service training 
provided to survey and audit personnel.
    (12) The evaluation systems used to monitor the performance of 
individual surveyors, auditors and survey teams.
    (13) The home infusion therapy accrediting organization's policies 
and procedures to avoid conflicts of interest, including the appearance 
of conflicts of interest, involving individuals who conduct surveys, 
audits or participate in accreditation decisions.
    (14) The policies and procedures used when a home infusion therapy 
supplier has a dispute regarding survey or audit findings, or an adverse 
decision.
    (15) Procedures for the home infusion therapy supplier to use to 
notify the home infusion therapy accrediting organization when the 
accredited home infusion therapy supplier does the either of the 
following:
    (i) Removes or ceases furnishing services for which they are 
accredited.
    (ii) Adds services for which they are not accredited.
    (16) The home infusion therapy accrediting organization's procedures 
for responding to, and investigating complaints against accredited 
facilities, including policies and procedures regarding referrals, when 
applicable, to appropriate licensing bodies, ombudsmen offices, and CMS.
    (17) A description of the home infusion therapy accrediting 
organization's accreditation status decision-making process. The home 
infusion therapy accrediting organization must furnish the following:
    (i) Its process for addressing deficiencies identified with 
accreditation program requirements, and the procedures used to monitor 
the correction of deficiencies identified during an accreditation survey 
and audit process.
    (ii) A description of all types and categories of accreditation 
decisions associated with the program, including the duration of each of 
the organization's accreditation decisions.

[[Page 583]]

    (iii) Its policies and procedures for the granting, withholding or 
removal of accreditation status for facilities that fail to meet the 
accrediting organization's standards or requirements, assignment of less 
than full accreditation status or other actions taken by the 
organization in response to non-compliance with its standards and 
requirements.
    (iv) A statement acknowledging that the home infusion therapy 
accrediting organization agrees to notify CMS (in a manner CMS 
specifies) of any decision to revoke, terminate, or revise the 
accreditation status of a home infusion therapy supplier, within 3 
business days from the date the organization takes an action.
    (18) A list of all currently accredited home infusion therapy 
suppliers, the type and category of accreditation, currently held by 
each, and the expiration date for each home infusion therapy supplier's 
current accreditation.
    (19) A schedule of all survey activity (such as onsite surveys, 
offsite audits and other types if survey strategies) expected to be 
conducted by the organization during the 6-month period following 
submission of an initial or renewal application.
    (20) A written presentation that demonstrates the organization's 
ability to furnish CMS with electronic data.
    (21) A description of the home infusion therapy accrediting 
organization's data management and analysis system with respect to its 
surveys and accreditation decisions, including all of the following:
    (i) A detailed description of how the home infusion therapy 
accrediting organization uses its data to assure the compliance of its 
home infusion therapy accreditation program with the Medicare home 
infusion therapy accreditation program requirements.
    (ii) A written statement acknowledging that the home infusion 
therapy accrediting organization agrees to submit timely, accurate, and 
complete data that CMS has determined is both necessary to evaluate the 
accrediting organization's performance and is not unduly burdensome for 
the accrediting organization to submit.
    (A) The organization must submit necessary data according to the 
instructions and timeframes CMS specifies.
    (B) Data to be submitted includes the following:
    (1) Accredited home infusion therapy supplier identifying 
information.
    (2) Survey findings.
    (3) Quality measures.
    (4) Notices of accreditation decisions.
    (22) The three most recent annual audited financial statements of 
the home infusion therapy accrediting organization that demonstrate that 
the organization's staffing, funding, and other resources are adequate 
to perform the required surveys, audits, and related activities to 
maintain the accreditation program.
    (23) A written statement acknowledging that, as a condition for 
approval, the home infusion therapy accrediting organization agrees to 
the following:
    (i) Voluntary termination. Provide written notification to CMS and 
all home infusion therapy suppliers accredited under its CMS-approved 
home infusion therapy accreditation program at least 180 calendar days 
in advance of the effective date of a decision by the home infusion 
therapy accrediting organization to voluntarily terminate its CMS-
approved home infusion therapy accreditation program and the 
implications for the suppliers' payment status once their current term 
of accreditation expires in accordance with the requirements at Sec. 
488.1045(a).
    (ii) Involuntary termination. Provide written notification to all 
accredited home infusion therapy suppliers accredited under its CMS-
approved home infusion therapy accreditation program no later than 30 
calendar days after the notice is published in the Federal Register 
announcing that CMS is withdrawing its approval of its accreditation 
program and the implications for the home infusion therapy supplier's 
payment status in accordance with the requirements at Sec. 488.1045(b) 
once their current term of accreditation expires.
    (A) For both voluntary and involuntary terminations, provide a 
second written notification to all accredited home infusion therapy 
suppliers 10 calendar days prior to the organization's

[[Page 584]]

accreditation program effective date of termination.
    (B) Notify CMS, in writing (electronically or hard copy), within 2 
business days of a deficiency identified in any accredited home infusion 
therapy supplier from any source where the deficiency poses an immediate 
jeopardy to the home infusion therapy supplier's beneficiaries or a 
hazard to the general public.
    (iii) Summary accreditation activity data and trends. Provide, on an 
annual basis, summary accreditation activity data and trends including 
the following:
    (A) Deficiencies.
    (B) Complaints.
    (C) Terminations.
    (D) Withdrawals.
    (E) Denials.
    (F) Accreditation decisions.
    (G) Other survey-related activities as specified by CMS.
    (iv) Termination of an accreditation organization. If CMS terminates 
a home infusion therapy accrediting organization's approved status, the 
home infusion therapy accrediting organization must work collaboratively 
with CMS to direct its accredited home infusion therapy suppliers to the 
remaining CMS-approved accrediting organizations within a reasonable 
period of time.
    (v) Notification of proposed changes. Notify CMS at least 60 days in 
advance of the implementation date of any significant proposed changes 
in its CMS-approved home infusion therapy accreditation program and that 
it agrees not to implement the proposed changes without prior written 
notice of continued program approval from CMS, except as provided for at 
Sec. 488.1040(b)(2).
    (vi) Response to a written notice from CMS. A statement 
acknowledging that, in response to a written notice from CMS to the home 
infusion therapy accrediting organization of a change in the applicable 
home infusion therapy accreditation requirements or survey process, the 
organization will provide CMS with proposed corresponding changes in the 
accrediting organization's home infusion therapy accreditation 
requirements for its CMS-approved home infusion therapy accreditation 
program to ensure that its accreditation standards continue to meet or 
exceed those of Medicare, or survey process remains comparable with that 
of Medicare. The home infusion therapy accrediting organization must 
comply with the following requirements:
    (A) The proposed changes must be submitted within 30 calendar days 
of the date of the written CMS notice to the home infusion therapy 
accrediting organization or by a date specified in the notice, whichever 
is later. CMS gives due consideration to a home infusion therapy 
accrediting organization's request for an extension of the deadline as 
long as it is submitted prior to the due date.
    (B) The proposed changes are not to be implemented without prior 
written notice of continued program approval from CMS, except as 
provided for at Sec. 488.1040(b)(2)(ii).
    (24) The organization's proposed fees for accreditation, including 
any plans for reducing the burden and cost of accreditation to small and 
rural suppliers.
    (b) Additional information needed. If CMS determines that additional 
information is necessary to make a determination for approval or denial 
of the home infusion therapy accrediting organization's initial 
application or re-application for CMS-approval of an accreditation 
program, CMS requires that the home infusion therapy accrediting 
organization s submit any specific documentation requirements and 
attestations as a condition of approval of accreditation status. CMS 
notifies the home infusion therapy accrediting organization and afford 
it an opportunity to provide the additional information.
    (c) Withdrawing an application. A home infusion therapy accrediting 
organization may withdraw its initial application for CMS' approval of 
its home infusion therapy accreditation program at any time before CMS 
publishes the final notice described in Sec. 488.1025(b).
    (d) Notice of approval or disapproval of application. CMS sends a 
notice of its decision to approve or disapprove the

[[Page 585]]

home infusion therapy accrediting organization's application within 210 
calendar days from the date CMS determines the home infusion therapy 
accrediting organization's application is complete. The final notice 
specifies the following:
    (1) The basis for the decision.
    (2) The effective date.
    (3) The term of the approval (not exceed 6 years).



Sec. 488.1015  Resubmitting a request for reapproval.

    (a) Except as provided in paragraph (b) of this section, a home 
infusion therapy accrediting organization whose request for CMS's 
approval or re-approval of an accreditation program has been denied, or 
a home infusion therapy accrediting organization that has voluntarily 
withdrawn an initial application, may resubmit its application if the 
home infusion therapy accrediting organization satisfies all of the 
following requirements:
    (1) Revises its home infusion therapy accreditation program to 
address the issues related to the denial of its previous request or its 
voluntary withdrawal.
    (2) Resubmits the application in its entirety.
    (b) If a home infusion therapy accrediting organization has 
requested, in accordance with Sec. 488.1050, a reconsideration of CMS's 
disapproval, it may not submit a new application for approval of a home 
infusion therapy accreditation program until such reconsideration is 
administratively final.



Sec. 488.1020  Public notice and comment.

    CMS publishes a notice in the Federal Register when the following 
conditions are met:
    (a) Proposed notice. CMS publishes a notice after the receipt of a 
completed application from a national home infusion therapy accrediting 
organization seeking CMS's approval of a home infusion therapy 
accreditation program. The notice identifies the home infusion therapy 
accrediting organization, the type of suppliers covered by the home 
infusion therapy accreditation program, and provides at least a 30 day 
public comment period (beginning on the date of publication).
    (b) Final notice. The final notice announces CMS decision to approve 
or deny a national accrediting organization application. The notice 
specifies the basis for the CMS decision.
    (1) Approval or re-approval. If CMS approves or re-approves the home 
infusion therapy accrediting organization's home infusion therapy 
accreditation program, the final notice at a minimum includes the 
following information:
    (i) A description of how the home infusion therapy accreditation 
program meets or exceeds Medicare home infusion therapy accreditation 
program requirements.
    (ii) The effective date of approval (no later than the publication 
date of the notice).
    (iii) The term of the approval (6 years or less).
    (2) Denial. If CMS does not approve the home infusion therapy 
accrediting organization's accreditation program, the final notice 
describes the following:
    (i) How the home infusion therapy accrediting organization fails to 
meet Medicare home infusion therapy accreditation program requirements.
    (ii) The effective date of the decision.



Sec. 488.1025  Release and use of home infusion therapy accreditation 
surveys.

    The home infusion therapy accrediting organization must include, in 
its accreditation agreement with each supplier, an acknowledgement that 
the supplier agrees to release to CMS a copy of its most current 
accreditation survey and any information related to the survey that CMS 
may require, corrective action plans.
    (a) CMS may determine that a home infusion therapy supplier does not 
meet the applicable Medicare conditions or requirements on the basis of 
its own investigation of the accreditation survey or any other 
information related to the survey.
    (b) With the exception of home health agency surveys, general 
disclosure of an accrediting organization's survey information is 
prohibited under section 1865(b) of the Act. CMS may publically disclose 
an accreditation survey and information related to the survey, upon 
written request, to the

[[Page 586]]

extent that the accreditation survey and survey information are related 
to an enforcement action taken by CMS.



Sec. 488.1030  Ongoing review of home infusion therapy accrediting
organizations.

    (a) Performance review. CMS evaluates the performance of each CMS-
approved home infusion therapy accreditation program on an ongoing 
basis. This review includes the review of the following:
    (1) The home infusion therapy accrediting organization's survey 
activity.
    (2) The home infusion therapy accrediting organization's continued 
fulfillment of the requirements at Sec. Sec. 488.1010 and 488.1035.
    (b) Comparability review. CMS assesses the equivalency of a home 
infusion therapy accrediting organization's CMS-approved program 
requirements with the comparable Medicare home infusion therapy 
accreditation requirements after CMS imposes new or revised Medicare 
accreditation requirements. When this occurs, the following takes place:
    (1) CMS provides the home infusion therapy accrediting organizations 
with written notice of the changes to the to the Medicare home infusion 
therapy accreditation requirements.
    (2) The home infusion therapy accrediting organization must make 
revisions to its home infusion therapy accreditation standards or survey 
processes which incorporate the new or revised Medicare accreditation 
requirements.
    (3) In the written notice, CMS specifies the deadline (no less than 
30 calendar days) by which the home infusion therapy accrediting 
organization must submit its proposed revised home infusion therapy 
accreditation standard or survey process revisions, and the timeframe(s) 
for implementation of these revised home infusion therapy accreditation 
standards.
    (4) CMS may extend the submission deadline by which the accrediting 
organization must submit its proposed revised home infusion therapy 
accreditation standards and survey processes, if both of the following 
occur:
    (i) The accrediting organization submits a written request for an 
extension of the submission deadline.
    (ii) The request for extension is submitted prior to the original 
submission deadline.
    (5) After completing the comparability review of the home infusion 
therapy accrediting organizations revised home infusion therapy 
accreditation standards and survey processes, CMS shall provide written 
notification to the home infusion therapy accrediting organization 
regarding whether or not its home infusion therapy accreditation 
program, including the proposed revised home infusion therapy 
accreditation standards and implementation timeframe(s), continues to 
meet or exceed all applicable Medicare requirements.
    (6) If, no later than 60 calendar days after receipt of the home 
infusion therapy accrediting organization's proposed changes, CMS does 
not provide the written notice to the home infusion therapy accrediting 
organization required, then the revised home infusion therapy 
accreditation standards and program is deemed to meet or exceed all 
applicable Medicare requirements and to have continued CMS-approval.
    (7) If a home infusion therapy accrediting organization is required 
to submit a new application because CMS imposes new home infusion 
therapy regulations or makes significant substantive revisions to the 
existing home infusion therapy regulations, CMS provides notice of the 
decision to approve or disapprove the new application submitted by the 
home infusion therapy accrediting organization within the time period 
specified in Sec. 488.1010(d).
    (8) If a home infusion therapy accrediting organization fails to 
submit its proposed changes to its home infusion therapy accreditation 
standards and survey processes within the required timeframe, or fails 
to implement the proposed changes that have been determined or deemed by 
CMS to be comparable, CMS may open an accreditation program review in 
accordance with paragraph (d) of this section.
    (c) Review of revised home infusion therapy accreditation standards 
submitted to CMS by an accrediting organization.

[[Page 587]]

When a home infusion therapy accrediting organization proposes to adopt 
new or revised accreditation standards, requirements or changes in its 
survey process, the home infusion therapy accrediting organization must 
do the following:
    (1) Provide CMS with written notice of any proposed changes in home 
infusion therapy accreditation standards, requirements or survey process 
at least 60 days prior to the proposed implementation date of the 
proposed changes.
    (2) Not implement any of the proposed changes before receiving CMS's 
approval, except as provided in paragraph (c)(4) of this section.
    (3) Provide written notice to CMS that includes all of the 
following:
    (i) A detailed description of the changes that are to be made to the 
organization's home infusion therapy accreditation standards, 
requirements and survey processes.
    (ii) A detailed crosswalk (in table format) that states the exact 
language of the organization's revised accreditation requirements and 
the applicable Medicare requirements for each.
    (4) CMS must provide a written notice to the home infusion therapy 
accrediting organization which states whether the home infusion therapy 
accreditation program, including the proposed revisions, continues or 
does not continue to meet or exceed all applicable Medicare home 
infusion therapy requirements within 60 days of receipt of the home 
infusion therapy accrediting organization's proposed changes. If CMS has 
made a finding that the home infusion therapy accrediting organization's 
home infusion therapy accreditation program, accreditation requirements 
and survey processes, including the proposed revisions does not continue 
to meet or exceed all applicable Medicare home infusion therapy 
requirements. CMS must state the reasons for these findings.
    (5) If, no later than 60 calendar days after receipt of the home 
infusion therapy accrediting organization's proposed changes, CMS does 
not provide written notice to the home infusion therapy accrediting 
organization that the home infusion therapy accreditation program, 
including the proposed revisions, continues or does not continue to meet 
or exceed all applicable Medicare home infusion therapy requirements, 
then the revised home infusion therapy accreditation program is deemed 
to meet or exceed all applicable Medicare home infusion therapy 
requirements and to have continued CMS approval.
    (6) If a home infusion therapy accrediting organization implements 
changes that have neither been determined nor deemed by CMS to be 
comparable to the applicable Medicare home infusion therapy 
requirements, CMS may open a home infusion therapy accreditation program 
review in accordance with paragraph (d) of this section.
    (d) CMS-approved home infusion therapy accreditation program review. 
If a comparability, performance, or standards review reveals evidence of 
substantial non-compliance of a home infusion therapy accrediting 
organization's CMS-approved home infusion therapy accreditation program 
with the requirements of this subpart, CMS may initiate a home infusion 
therapy accreditation program review.
    (1) If a home infusion therapy accreditation program review is 
initiated, CMS will provide written notice to the home infusion therapy 
accrediting organization indicating that its CMS-approved accreditation 
program approval may be in jeopardy and that a home infusion therapy 
accreditation program review is being initiated. The notice will provide 
all of the following information:
    (i) A statement of the instances, rates or patterns of non-
compliance identified, as well as other related information, if 
applicable.
    (ii) A description of the process to be followed during the review, 
including a description of the opportunities for the home infusion 
therapy accrediting organization to offer factual information related to 
CMS' findings.
    (iii) A description of the possible actions that may be imposed by 
CMS based on the findings of the home infusion therapy accreditation 
program review.
    (iv) The actions the home infusion therapy accrediting organization 
must take to address the identified deficiencies

[[Page 588]]

    (v) The length of the accreditation program review probation period, 
which will include monitoring of the home infusion therapy accrediting 
organization's performance and implementation of the corrective action 
plan. The probation period is not to exceed 180 calendar days from the 
date that CMS approves the AOs corrective action plan.
    (2) CMS will review and approve the home infusion therapy 
accrediting organization's plan of correction for acceptability within 
30 days after receipt.
    (3) CMS will monitor the AO's performance and implementation of the 
plan of correction during the probation period which is not to exceed 
180 days from the date of approval of the plan of correction.
    (4) If CMS determines, as a result of the home infusion therapy 
accreditation program review or a review of an application for renewal 
of the accrediting organizations existing CMS-approved home infusion 
therapy accreditation program, that the home infusion therapy 
accrediting organization has failed to meet any of the requirements of 
this subpart, CMS may place the home infusion therapy accrediting 
organization's CMS-approved home infusion therapy accreditation program 
on an additional probation period of up to 180 calendar days subsequent 
to the 180-day probation period described in paragraph (d)(1)(v) of this 
section to implement additional corrective actions or demonstrate 
sustained compliance, not to exceed the home infusion therapy 
accrediting organization's current term of approval. In the case of a 
renewal application where CMS has already placed the home infusion 
therapy accreditation program on probation, CMS indicates that any 
approval of the application is conditional while the program is placed 
on probation.
    (i) Within 60 calendar days after the end of any probationary 
period, CMS issues a written determination to the home infusion therapy 
accrediting organization as to whether or not its CMS-approved home 
infusion therapy accreditation program continues to meet the 
requirements of this subpart, including the reasons for the 
determination.
    (ii) If CMS determines that the home infusion therapy accrediting 
organization does not meet the requirements, CMS may withdraw approval 
of the CMS-approved home infusion therapy accreditation program. The 
notice of determination provided to the home infusion therapy 
accrediting organization includes notice of the removal of approval, 
reason for the removal, including the effective date determined in 
accordance with paragraph (d)(4)(iii) of this section.
    (iii) CMS publishes in the Federal Register a notice of its decision 
to withdraw approval of a CMS-approved accreditation program, including 
the reasons for the withdrawal, effective 60 calendar days after the 
date of publication of the notice.
    (e) Immediate jeopardy. If at any time CMS determines that the 
continued approval of a CMS-approved home infusion therapy accreditation 
program of any home infusion therapy accrediting organization poses an 
immediate jeopardy to the patients of the suppliers accredited under the 
program, or the continued approval otherwise constitutes a significant 
hazard to the public health, CMS may immediately withdraw the approval 
of a CMS-approved home infusion therapy accreditation program of that 
home infusion therapy accrediting organization and publish a notice of 
the removal, including the reasons for it, in the Federal Register.
    (f) Notification to home infusion therapy suppliers of withdrawal of 
CMS approval status. A home infusion therapy accrediting organization 
whose CMS approval of its home infusion therapy accreditation program 
has been withdrawn must notify each of its accredited home infusion 
therapy suppliers, in writing, of the withdrawal of CMS approval status 
no later than 30 calendar days after the notice is published in the 
Federal Register. The notification to the accredited home infusion 
therapy suppliers must inform them of the implications for their payment 
status once their current term of accreditation expires.

[[Page 589]]



Sec. 488.1035  Ongoing responsibilities of a CMS-approved home 
infusion therapy accrediting organization.

    A home infusion therapy accreditation organization approved by CMS 
must carry out the following activities on an ongoing basis:
    (a) Provide CMS with all of the following in written format (either 
electronic or hard copy):
    (1) Copies of all home infusion therapy accreditation surveys, 
together with any survey-related information that CMS may require 
(including corrective action plans and summaries of findings with 
respect to unmet CMS requirements).
    (2) Notice of all accreditation decisions.
    (3) Notice of all complaints related to providers or suppliers.
    (4) Information about all home infusion therapy accredited suppliers 
against which the home infusion therapy accreditation organization has 
taken remedial or adverse action, including revocation, withdrawal, or 
revision of the providers or suppliers accreditation.
    (5) The home infusion therapy accrediting organization must provide, 
on an annual basis, summary data specified by CMS that relate to the 
past year's accreditation activities and trends.
    (6) Notice of any proposed changes in the home infusion therapy 
accrediting organization's accreditation standards or requirements or 
survey process. If the home infusion therapy accrediting organization 
implements the changes before or without CMS' approval, CMS may withdraw 
its approval of the accrediting organization.
    (b) Within 30 calendar days after a change in CMS requirements, the 
home infusion therapy accrediting organization must submit an 
acknowledgment of receipt of CMS' notification to CMS.
    (c) The home infusion therapy accrediting organization must permit 
its surveyors to serve as witnesses if CMS takes an adverse action based 
on accreditation findings.
    (d) Within 2 business days of identifying a deficiency of an 
accredited home infusion therapy supplier that poses immediate jeopardy 
to a beneficiary or to the general public, the home infusion therapy 
accrediting organization must provide CMS with written notice of the 
deficiency and any adverse action implemented by the accrediting 
organization.
    (e) Within 10 calendar days after CMS' notice to a CMS-approved home 
infusion therapy accrediting organization that CMS intends to withdraw 
approval of the home infusion therapy accrediting organization, the home 
infusion therapy accrediting organization must provide written notice of 
the withdrawal to all of the home infusion therapy accrediting 
organization's accredited suppliers.



Sec. 488.1040  Onsite observations of home infusion therapy
accrediting organization operations.

    (a) As part of the application review process, the ongoing review 
process, or the continuing oversight of a home infusion therapy 
accrediting organization's performance, CMS may conduct onsite 
inspections of the home infusion therapy accrediting organization's 
operations and offices at any time to verify the home infusion therapy 
accrediting organization's representations and to assess the home 
infusion therapy accrediting organization's compliance with its own 
policies and procedures.
    (b) Activities to be performed by CMS staff during the onsite 
inspections may include, but are not limited to the following:
    (1) Interviews with various accrediting organization staff.
    (2) Review of documents, survey files, audit tools, and related 
records.
    (3) Observation of meetings concerning the home infusion therapy 
accreditation process.
    (4) Auditing meetings concerning the accreditation process.
    (5) Observation of in-progress surveys and audits.
    (6) Evaluation of the accrediting organization's survey results and 
accreditation decision-making process.



Sec. 488.1045  Voluntary and involuntary termination.

    (a) Voluntary termination by a CMS-approved accrediting program. In 
accordance with Sec. 488.1010(a)(23), a home infusion therapy 
accrediting organization

[[Page 590]]

that decides to voluntarily terminate its CMS-approved home infusion 
therapy accreditation program must provide written notice at least 180 
days in advance of the effective date of the termination to CMS and each 
of its accredited home infusion therapy suppliers.
    (b) Involuntary termination of an accrediting organization's 
approval by CMS. Once CMS publishes the notice in the Federal Register 
announcing its decision terminate the home infusion therapy accrediting 
organization's home infusion therapy accreditation program, the home 
infusion therapy accrediting organization must provide written 
notification to all suppliers accredited under its CMS-approved home 
infusion therapy accreditation program no later than 30 calendar days 
after the notice is published in the Federal Register announcing that 
CMS is withdrawing its approval of its home infusion therapy 
accreditation program and the implications for the home infusion therapy 
suppliers payment status in accordance with the requirements at Sec. 
488.1010(f) once their current term of accreditation expires.
    (c) Voluntary and involuntary terminations. For both voluntary and 
involuntary terminations--
    (1) The accreditation status of affected home infusion therapy 
suppliers is considered to remain in effect until their current term of 
accreditation expires;
    (2) If the home infusion therapy supplier wishes to avoid a 
suspension of payment, it must provide written notice to CMS at least 
60-calendar days prior to its accreditation expiration date that it has 
submitted an application for home infusion therapy accreditation under 
another CMS-approved home infusion therapy accreditation program. 
Failure to comply with this 60-calendar day requirement prior to 
expiration of their current home infusion therapy accreditation stations 
within could result in a suspension of payment; and
    (3) The home infusion therapy accrediting organization provides a 
second written notification to all accredited home infusion therapy 
suppliers ten calendar days prior to the organization's accreditation 
program effective date of termination.
    (d) Voluntary withdrawal from accreditation requested by a home 
infusion therapy supplier. If a voluntary withdrawal from accreditation 
is requested by the home infusion therapy supplier, the withdrawal may 
not become effective until the accrediting organization completes all of 
the following steps:
    (1) The accrediting organization must contact the home infusion 
therapy supplier to seek written confirmation that the home infusion 
therapy supplier intends to voluntarily withdraw from the home infusion 
therapy accreditation program.
    (2) The home infusion therapy accrediting organization must advise 
the home infusion therapy supplier, in writing, of the statutory 
requirement for accreditation for all home infusion therapy suppliers 
and the possible payment consequences for a lapse in accreditation 
status.
    (3) The home infusion therapy accrediting organization must submit 
their final notice of the voluntary withdrawal of accreditation by the 
home infusion therapy supplier to CMS by 5 business days after the 
request for voluntary withdrawal is ultimately processed and effective.



Sec. 488.1050  Reconsideration.

    (a) General rule. A home infusion therapy accrediting organization 
dissatisfied with a determination that its home infusion therapy 
accreditation requirements do not provide or do not continue to provide 
reasonable assurance that the suppliers accredited by the home infusion 
therapy accrediting organization meet the applicable quality standards 
is entitled to reconsideration.
    (b) Filing requirements. (1) A written request for reconsideration 
must be filed within 30 calendar days of the receipt of CMS notice of an 
adverse determination or non-renewal.
    (2) The written request for reconsideration must specify the 
findings or issues with which the home infusion therapy accrediting 
organization disagrees and the reasons for the disagreement.
    (3) A requestor may withdraw its written request for reconsideration 
at

[[Page 591]]

any time before the issuance of a reconsideration determination.
    (c) CMS response to a request for reconsideration. In response to a 
request for reconsideration, CMS provides the accrediting organization 
with--
    (1) The opportunity for a hearing to be conducted by a hearing 
officer appointed by the Administrator of CMS and provide the 
accrediting organization the opportunity to present, in writing and in 
person, evidence or documentation to refute the determination to deny 
approval, or to withdraw or not renew designation; and
    (2) Written notice of the time and place of the hearing at least 10 
business days before the scheduled date.
    (d) Hearing requirements and rules. (1) The reconsideration hearing 
is a public hearing open to all of the following:
    (i) Authorized representatives and staff from CMS, including, but 
not limited to, the following:
    (A) Technical advisors (individuals with knowledge of the facts of 
the case or presenting interpretation of the facts).
    (B) Legal counsel.
    (C) Non-technical witnesses with personal knowledge of the facts of 
the case.
    (ii) Representatives from the accrediting organization requesting 
the reconsideration including, but not limited to, the following:
    (A) Authorized representatives and staff from the accrediting 
organization.
    (B) Technical advisors (individuals with knowledge of the facts of 
the case or presenting interpretation of the facts).
    (C) Legal counsel.
    (D) Non-technical witnesses, such as patients and family members 
that have personal knowledge of the facts of the case.
    (2) The hearing is conducted by the hearing officer who receives 
testimony and documents related to the proposed action.
    (3) Testimony and other evidence may be accepted by the hearing 
officer even though such evidence may be inadmissible under the Federal 
Rules of Civil Procedure.
    (4) The hearing officer does not have the authority to compel by 
subpoena the production of witnesses, papers, or other evidence.
    (5) Within 45 calendar days after the close of the hearing, the 
hearing officer will present the findings and recommendations to the 
accrediting organization that requested the reconsideration.
    (6) The written report of the hearing officer will include separate 
numbered findings of fact and the legal conclusions of the hearing 
officer.
    (7) The hearing officer's decision is final.



PART 489_PROVIDER AGREEMENTS AND SUPPLIER APPROVAL--Table of Contents



                      Subpart A_General Provisions

Sec.
489.1 Statutory basis.
489.2 Scope of part.
489.3 Definitions.
489.10 Basic requirements.
489.11 Acceptance of a provider as a participant.
489.12 Decision to deny an agreement.
489.13 Effective date of agreement or approval.
489.18 Change of ownership or leasing: Effect on provider agreement.

               Subpart B_Essentials of Provider Agreements

489.20 Basic commitments.
489.21 Specific limitations on charges.
489.22 Special provisions applicable to prepayment requirements.
489.23 Specific limitation on charges for services provided to certain 
          enrollees of fee-for-service FEHB plans.
489.24 Special responsibilities of Medicare hospitals in emergency 
          cases.
489.25 Special requirements concerning CHAMPUS and CHAMPVA programs.
489.26 Special requirements concerning veterans.
489.27 Beneficiary notice of discharge rights.
489.28 Special capitalization requirements for HHAs.
489.29 Special requirements concerning beneficiaries served by the 
          Indian Health Service, Tribal health programs, and urban 
          Indian organization health programs.

                       Subpart C_Allowable Charges

489.30 Allowable charges: Deductibles and coinsurance.
489.31 Allowable charges: Blood.

[[Page 592]]

489.32 Allowable charges: Noncovered and partially covered services.
489.34 Allowable charges: Hospitals participating in State reimbursement 
          control systems or demonstration projects.
489.35 Notice to intermediary.

               Subpart D_Handling of Incorrect Collections

489.40 Definition of incorrect collection.
489.41 Timing and methods of handling.
489.42 Payment of offset amounts to beneficiary or other person.

 Subpart E_Termination of Agreement and Reinstatement After Termination

489.52 Termination by the provider.
489.53 Termination by CMS.
489.54 Termination by the OIG.
489.55 Exceptions to effective date of termination.
489.57 Reinstatement after termination.

               Subpart F_Surety Bond Requirements for HHAs

489.60 Definitions.
489.61 Basic requirement for surety bonds.
489.62 Requirement waived for Government-operated HHAs.
489.63 Parties to the bond.
489.64 Authorized Surety and exclusion of surety companies.
489.65 Amount of the bond.
489.66 Additional requirements of the surety bond.
489.67 Term and type of bond.
489.68 Effect of failure to obtain, maintain, and timely file a surety 
          bond.
489.69 Evidence of compliance.
489.70 Effect of payment by the Surety.
489.71 Surety's standing to appeal Medicare determinations.
489.72 Effect of review reversing CMS's determination.
489.73 Effect of conditions of payment.
489.74 Incorporation into existing provider agreements.

Subparts G-H [Reserved]

                      Subpart I_Advance Directives

489.100 Definition.
489.102 Requirements for providers.
489.104 Effective dates.

    Authority: 42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc, 
1395ff, and 1395hh.

    Source: 45 FR 22937, Apr. 4, 1980, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 489.1  Statutory basis.

    (a) This part implements section 1866 of the Social Security Act 
(the Act). Section 1866 of the Act specifies the terms of provider 
agreements, the grounds for terminating a provider agreement, the 
circumstances under which payment for new admissions may be denied, and 
the circumstances under which payment may be withheld for failure to 
make timely utilization review. The sections of the Act specified in 
paragraphs (a)(1) through (a)(4) of this section are also pertinent.
    (1) Section 1861 of the Act defines the services covered under 
Medicare and the providers that may be reimbursed for furnishing those 
services.
    (2) Section 1864 of the Act provides for the use of State survey 
agencies to ascertain whether certain entities meet the conditions of 
participation.
    (3) Section 1865(a)(1) of the Act provides that an entity accredited 
by a national accreditation body found by the Secretary to satisfy the 
Medicare conditions of participation, conditions for coverage, or 
conditions of certification or requirements for participation shall be 
treated as meeting those requirements. Section 1865(a)(2) of the Act 
requires the Secretary to consider when making such a finding, among 
other things, the national accreditation body's accreditation 
requirements and survey procedures.
    (4) Section 1871 of the Act authorizes the Secretary to prescribe 
regulations for the administration of the Medicare program.
    (b) Although section 1866 of the Act speaks only to providers and 
provider agreements, the following rules in this part also apply to the 
approval of supplier entities that, for participation in Medicare, are 
subject to a determination by CMS on the basis of a survey conducted by 
the SA or CMS surveyors; or, in lieu of an SA or CMS-conducted survey, 
accreditation by an accrediting organization whose program has CMS 
approval in accordance with the requirements of part 488 of this chapter 
at the time of the accreditation survey and accreditation decision, in 
accordance with the following:

[[Page 593]]

    (1) The definition of immediate jeopardy at Sec. 489.3.
    (2) The effective date rules specified in Sec. 489.13.
    (3) The requirements specified in Sec. 489.53(a)(2), (13), and 
(18), related to termination by CMS of participation in Medicare.
    (c) Section 1861(o)(7) of the Act requires each HHA to provide CMS 
with a surety bond.

[75 FR 50418, Aug. 16, 2010, as amended at 80 FR 29839, May 22, 2015]



Sec. 489.2  Scope of part.

    (a) Subpart A of this part sets forth the basic requirements for 
submittal and acceptance of a provider agreement under Medicare. Subpart 
B of this part specifies the basic commitments and limitations that the 
provider must agree to as part of an agreement to provide services. 
Subpart C specifies the limitations on allowable charges to 
beneficiaries for deductibles, coinsurance, copayments, blood, and 
services that must be part of the provider agreement. Subpart D of this 
part specifies how incorrect collections are to be handled. Subpart F 
sets forth the circumstances and procedures for denial of payments for 
new admissions and for withholding of payment as an alternative to 
termination of a provider agreement.
    (b) The following providers are subject to the provisions of this 
part:
    (1) Hospitals.
    (2) Skilled nursing facilities (SNFs).
    (3) Home health agencies (HHAs).
    (4) Clinics, rehabilitation agencies, and public health agencies.
    (5) Comprehensive outpatient rehabilitation facilities (CORFs).
    (6) Hospices.
    (7) Critical access hospital (CAHs).
    (8) Community mental health centers (CMHCs).
    (9) Religious nonmedical health care institutions (RNHCIs).
    (10) Opioid treatment programs (OTPs).
    (c)(1) Clinics, rehabilitation agencies, and public health agencies 
may enter into provider agreements only for furnishing outpatient 
physical therapy, and speech pathology services.
    (2) CMHCs may enter into provider agreements only to furnish partial 
hospitalization services.
    (3) OTPs may enter into provider agreements only to furnish opioid 
use disorder treatment services.

[45 FR 22937, Apr. 4, 1980, as amended at 47 FR 56297, Dec. 15, 1982; 48 
FR 56036, Dec. 15, 1983; 51 FR 24492, July 3, 1986; 58 FR 30676, May 26, 
1993; 59 FR 6578, Feb. 11, 1994; 62 FR 46037, Aug. 29, 1997; 68 FR 
66720, Nov. 28, 2003; 84 FR 63204, Nov. 15, 2019]



Sec. 489.3  Definitions.

    For purposes of this part--
    Immediate jeopardy means a situation in which the provider's or 
supplier's non-compliance with one or more requirements, conditions of 
participation, conditions for coverage, or conditions for certification 
has caused, or is likely to cause, serious injury, harm, impairment, or 
death to a resident or patient.
    Physician-owned hospital means any participating hospital (as 
defined in Sec. 489.24) in which a physician, or an immediate family 
member of a physician (as defined in Sec. 411.351 of this chapter), has 
an ownership or investment interest in the hospital. The ownership or 
investment interest may be through equity, debt, or other means, and 
includes an interest in an entity that holds an ownership or investment 
interest in the hospital. This definition does not include a hospital 
with physician ownership or investment interests that satisfy the 
requirements at Sec. 411.356(a) or (b) of this chapter.
    Provider agreement means an agreement between CMS and one of the 
providers specified in Sec. 489.2(b) to provide services to Medicare 
beneficiaries and to comply with the requirements of section 1866 of the 
Act.

[48 FR 39837, Sept. 1, 1983, as amended at 51 FR 24492, July 3, 1986; 54 
FR 5373, Feb. 2, 1989; 59 FR 56250, Nov. 10, 1994; 60 FR 50119, Sept. 
28, 1995; 72 FR 47412, Aug. 22, 2007; 73 FR 48757, Aug. 19, 2008; 80 FR 
29840, May 22, 2015]



Sec. 489.10  Basic requirements.

    (a) Any of the providers specified in Sec. 489.2 may request 
participation in Medicare. In order to be accepted, it must meet the 
conditions of participation or requirements (for SNFs) set forth in this 
section and elsewhere in

[[Page 594]]

this chapter. The RNHCIs must meet the conditions for coverage, 
conditions for participation and the requirements set forth in this 
section and elsewhere in this chapter. The OTPs must meet the 
requirements set forth in this section and elsewhere in this chapter.
    (b) In order to participate in the Medicare program, the provider 
must meet the applicable civil rights requirements of:
    (1) Title VI of the Civil Rights Act of 1964, as implemented by 45 
CFR part 80, which provides that no person in the United States shall, 
on the ground of race, color, or national origin, be excluded from 
participation in, be denied the benefits of, or be subject to 
discrimination under, any program or activity receiving Federal 
financial assistance (section 601);
    (2) Section 504 of the Rehabilitation Act of 1973, as implemented by 
45 CFR part 84, which provides that no qualified handicapped person 
shall, on the basis of handicap, be excluded from participation in, be 
denied the benefits of, or otherwise be subject to discrimination under 
any program or activity receiving Federal financial assistance;
    (3) The Age Discrimination Act of 1975, as implemented by 45 CFR 
part 90, which is designed to prohibit discrimination on the basis of 
age in programs or activities receiving Federal financial assistance. 
The Age Discrimination Act also permits federally assisted programs and 
activities, and beneficiaries of Federal funds, to continue to use 
certain age distinctions, and factors other than age, that meet the 
requirements of the Age Discrimination Act and 45 CFR part 90; and
    (4) Other pertinent requirements of the Office of Civil Rights of 
HHS.
    (c) In order for a hospital, SNF, HHA, hospice, or RNHCI to be 
accepted, it must also meet the advance directives requirements 
specified in subpart I of this part.
    (d) The State survey agency will ascertain whether the provider 
meets the conditions of participation or requirements (for SNFs) and 
make its recommendations to CMS.
    (e) In order for a home health agency to be accepted, it must also 
meet the surety bond requirements specified in subpart F of this part.
    (f) In order for a home health agency to be accepted as a new 
provider, it must also meet the capitalization requirements specified in 
subpart B of this part.

[58 FR 61843, Nov. 23, 1993, as amended at 59 FR 6578, Feb. 11, 1994; 63 
FR 312, Jan. 5, 1998; 68 FR 66720, Nov. 28, 2003; 84 FR 63204, Nov. 15, 
2019]



Sec. 489.11  Acceptance of a provider as a participant.

    (a) Action by CMS. If CMS determines that the provider meets the 
requirements, it will send the provider--
    (1) Written notice of that determination; and
    (2) Two copies of the provider agreement.
    (b) Action by provider. If the provider wishes to participate, it 
must return both copies of the agreement, duly signed by an authorized 
official, to CMS, together with a written statement indicating whether 
it has been adjudged insolvent or bankrupt in any State or Federal 
court, or whether any insolvency or bankruptcy actions are pending.
    (c) Notice of acceptance. If CMS accepts the agreement, it will 
return one copy to the provider with a written notice that--
    (1) Indicates the dates on which it was signed by the provider's 
representative and accepted by CMS; and
    (2) Specifies the effective date of the agreement.

[45 FR 22937, Apr. 4, 1980, as amended at 59 FR 56251, Nov. 10, 1994; 62 
FR 43937, Aug. 18, 1997]



Sec. 489.12  Decision to deny an agreement.

    (a) Bases for denial. CMS may refuse to enter into an agreement for 
any of the following reasons:
    (1) Principals of the prospective provider have been convicted of 
fraud (see Sec. 420.204 of this chapter);
    (2) The prospective provider has failed to disclose ownership and 
control interests in accordance with Sec. 420.206 of this chapter;
    (3) The prospective provider is a physician-owned hospital as 
defined in Sec. 489.3 and does not have procedures in place for making 
physician ownership

[[Page 595]]

disclosures to patients in accordance with Sec. 489.20(u); or
    (4) The prospective provider is unable to give satisfactory 
assurance of compliance with the requirements of title XVIII of the Act.
    (b) [Reserved]
    (c) Compliance with civil rights requirements. CMS will not enter 
into a provider agreement if the provider fails to comply with civil 
rights requirements set forth in 45 CFR parts 80, 84, and 90, subject to 
the provisions of Sec. 489.10.

[45 FR 22937, Apr. 4, 1980, as amended at 51 FR 34833, Sept. 30, 1986; 
54 FR 4027, Jan. 27, 1989; 59 FR 6578, Feb. 11, 1994; 59 FR 56251, Nov. 
10, 1994; 72 FR 47413, Aug. 22, 2007]



Sec. 489.13  Effective date of agreement or approval.

    (a) Applicability--(1) General rule. Except as provided in paragraph 
(a)(2) of this section, this section applies to Medicare provider 
agreements with, and supplier approval of, entities that, as a basis for 
participation in Medicare are subject to a determination by CMS on the 
basis of--
    (i) A survey conducted by the State survey agency or CMS surveyors; 
or
    (ii) In lieu of such State survey agency or CMS conducted survey, 
accreditation by an accreditation organization whose program has CMS 
approval in accordance with section 1865 of the Act at the time of the 
accreditation survey and accreditation decision.
    (2) Exceptions. (i) For an agreement with a community mental health 
center (CMHC) or a federally qualified health center (FQHC), the 
effective date is the date on which CMS accepts a signed agreement which 
assures that the CMHC or FQHC meets all Federal requirements.
    (ii) A Medicare supplier approval of 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.
    (iii) For an agreement with an opioid treatment program (OTP), the 
effective date is the effective date of billing as established under 
Sec. 424.520(d) or Sec. 424.521(a), as applicable.
    (b) All health and safety standards are met on the date of survey. 
The agreement or approval is effective on the date the State agency, 
CMS, or the CMS contractor survey (including the Life Safety Code 
survey, if applicable) is completed, or on the effective date of the 
accreditation decision, as applicable, if on that date the provider or 
supplier meets all applicable Federal requirements as set forth in this 
chapter. (If the agreement or approval is time-limited, the new 
agreement or approval is effective on the day following the expiration 
of the current agreement or approval.) However, the effective date of 
the agreement or approval may not be earlier than the latest of the 
dates on which CMS determines that each applicable Federal requirement 
is met. Federal requirements include, but are not limited to--
    (1) Enrollment requirements established in part 424, subpart P, of 
this chapter. CMS determines, based upon its review and verification of 
the prospective provider's or supplier's enrollment application, the 
date on which enrollment requirements have been met;
    (2) The requirements identified in Sec. Sec. 489.10 and 489.12; and
    (3) The applicable Medicare health and safety standards, such as the 
applicable conditions of participation, the requirements for 
participation, the conditions for coverage, or the conditions for 
certification.
    (c) All health and safety standards are not met on the date of 
survey. If, on the date the survey is completed, the provider or 
supplier has failed to meet any one of the applicable health and safety 
standards, the following rules apply for determining the effective date 
of the provider agreement or supplier approval, assuming that no other 
Federal requirements remain to be satisfied. However, if other Federal 
requirements remain to be satisfied, notwithstanding the provisions of 
paragraphs (c)(1) through (c)(3) of this section, the effective date of 
the agreement or approval may not be earlier than the latest of the 
dates on which CMS determines that each applicable Federal requirement 
is met.
    (1) For an agreement with an SNF, the effective date is the date on 
which--

[[Page 596]]

    (i) The SNF is in substantial compliance (as defined in Sec. 
488.301 of this chapter) with the requirements for participation; and
    (ii) CMS or the State survey agency receives from the SNF, if 
applicable, an approvable waiver request.
    (2) For an agreement with, or an approval of, any other provider or 
supplier, (except those specified in paragraph (a)(2) of this section), 
the effective date is the earlier of the following:
    (i) The date on which the provider or supplier meets all applicable 
conditions of participation, conditions for coverage, or conditions for 
certification; or, if applicable, the date of a CMS-approved 
accreditation organization program's positive accreditation decision, 
issued after the accreditation organization has determined that the 
provider or supplier meets all applicable conditions.
    (ii) The date on which a provider or supplier is found to meet all 
conditions of participation, conditions for coverage, or conditions for 
certification, but has lower-level deficiencies, and--
    (A) CMS or the State survey agency receives an acceptable plan of 
correction for the lower-level deficiencies (the date of receipt is the 
effective date regardless of when the plan of correction is approved); 
or, if applicable, a CMS-approved accreditation organization program 
issues a positive accreditation decision after it receives an acceptable 
plan of correction for the lower-level deficiencies; or
    (B) CMS receives an approvable waiver request (the date of receipt 
is the effective date regardless of when CMS approves the waiver 
request).
    (3) For an agreement with any other provider or an approval of any 
other supplier (except those specified in paragraph (a)(2) of this 
section) that is found to meet all conditions of participation, 
conditions for coverage, or conditions for certification, but has lower-
level deficiencies and has submitted both an approvable plan of 
correction/positive accreditation decision and an approvable waiver 
request, the effective date is the later of the dates that result when 
calculated in accordance with paragraph (c)(2)(ii)(A) or (c)(2)(ii)(B) 
of this section.

[75 FR 50418, Aug. 16, 2010, as amended at 84 FR 63204, Nov. 15, 2019]



Sec. 489.18  Change of ownership or leasing: Effect on provider agreement.

    (a) What constitutes change of ownership--(1) Partnership. In the 
case of a partnership, the removal, addition, or substitution of a 
partner, unless the partners expressly agree otherwise, as permitted by 
applicable State law, constitutes change of ownership.
    (2) Unincorporated sole proprietorship. Transfer of title and 
property to another party constitutes change of ownership.
    (3) Corporation. The merger of the provider corporation into another 
corporation, or the consolidation of two or more corporations, resulting 
in the creation of a new corporation constitutes change of ownership. 
Transfer of corporate stock or the merger of another corporation into 
the provider corporation does not constitute change of ownership.
    (4) Leasing. The lease of all or part of a provider facility 
constitutes change of ownership of the leased portion.
    (b) Notice to CMS. A provider who is contemplating or negotiating a 
change of ownership must notify CMS.
    (c) Assignment of agreement. When there is a change of ownership as 
specified in paragraph (a) of this section, the existing provider 
agreement will automatically be assigned to the new owner.
    (d) Conditions that apply to assigned agreements. An assigned 
agreement is subject to all applicable statutes and regulations and to 
the terms and conditions under which it was originally issued including, 
but not limited to, the following:
    (1) Any existing plan of correction.
    (2) Compliance with applicable health and safety standards.
    (3) Compliance with the ownership and financial interest disclosure 
requirements of part 420, subpart C, of this chapter.
    (4) Compliance with civil rights requirements set forth in 45 CFR 
parts 80, 84, and 90.

[[Page 597]]

    (e) Effect of leasing. The provider agreement will be assigned to 
the lessee only to the extent of the leased portion of the facility.

[45 FR 22937, Apr. 4, 1980, as amended at 59 FR 56251, Nov. 10, 1994]



               Subpart B_Essentials of Provider Agreements



Sec. 489.20  Basic commitments.

    The provider agrees to the following:
    (a) To limit its charges to beneficiaries and to other individuals 
on their behalf, in accordance with provisions of subpart C of this 
part.
    (b) To comply with the requirements of subpart D of this part for 
the return or other disposition of any amounts incorrectly collected 
from a beneficiary or any other person in his or her behalf.
    (c) To comply with the requirements of Sec. 420.203 of this chapter 
when it hires certain former employees of intermediaries.
    (d) In the case of a hospital or a CAH that furnishes services to 
Medicare beneficiaries, either to furnish directly or to make 
arrangements (as defined in Sec. 409.3 of this chapter) for all 
Medicare-covered services to inpatients and outpatients of a hospital or 
a CAH except the following:
    (1) Physicians' services that meet the criteria of Sec. 415.102(a) 
of this chapter for payment on a reasonable charge basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act, that are furnished after December 31, 1990.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse-midwife services, as defined in section 1861(ff) 
of the Act, that are furnished after December 31, 1990.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act, that are furnished after December 31, 1990.
    (6) Services of an anesthetist, as defined in Sec. 410.69 of this 
chapter.
    (e) In the case of a hospital or CAH that furnishes inpatient 
hospital services or inpatient CAH services for which payment may be 
made under Medicare, to maintain an agreement with a QIO for that 
organization to review the admissions, quality, appropriateness, and 
diagnostic information related to those inpatient services. The 
requirement of this paragraph (e) applies only if, for the area in which 
the hospital or CAH is located, there is a QIO that has a contract with 
CMS under part B of title XI of the Act.
    (f) To maintain a system that, during the admission process, 
identifies any primary payers other than Medicare, so that incorrect 
billing and Medicare overpayments can be prevented.
    (g) To bill other primary payers before Medicare.
    (h) If the provider receives payment for the same services from 
Medicare and another payer that is primary to Medicare, to reimburse 
Medicare any overpaid amount within 60 days.
    (i) If the provider receives, from a payer that is primary to 
Medicare, a payment that is reduced because the provider failed to file 
a proper claim--
    (1) To bill Medicare for an amount no greater than would have been 
payable as secondary payment if the primary insurer's payment had been 
based on a proper claim; and
    (2) To charge the beneficiary only: (i) The amount it would have 
been entitled to charge if it had filed a proper claim and received 
payment based on such a claim; and
    (ii) An amount equal to any primary payment reduction attributable 
to failure to file a proper claim, but only if the provider can show 
that--
    (A) It failed to file a proper claim solely because the beneficiary, 
for any reason other than mental or physical incapacity, failed to give 
the provider the necessary information; or
    (B) The beneficiary, who was responsible for filing a proper claim, 
failed to do so for any reason other than mental or physical incapacity.
    (j) In the State of Oregon, because of a court decision, and in the 
absence of a reversal on appeal or a statutory clarification overturning 
the decision, hospitals may bill liability insurers first. However, if 
the liability insurer does not pay ``promptly'', as defined in Sec. 
411.50 of this chapter, the hospital must withdraw its claim or lien and 
bill Medicare for covered services.

[[Page 598]]

    (k) In the case of home health agencies that provide home health 
services to Medicare beneficiaries under subpart E of part 409 and 
subpart C f part 410 of this chapter, to offer to furnish catheters, 
catheter supplies, ostomy bags, and supplies related to ostomy care to 
any individual who requires them as part of their furnishing of home 
health services.
    (l) In the case of a hospital as defined in Sec. 489.24(b) to 
comply with Sec. 489.24.
    (m) In the case of a hospital as defined in Sec. 489.24(b), to 
report to CMS or the State survey agency any time it has reason to 
believe it may have received an individual who has been transferred in 
an unstable emergency medical condition from another hospital in 
violation of the requirements of Sec. 489.24(e).
    (n) In the case of inpatient hospital services, to participate in 
any health plan contracted for under 10 U.S.C. 1079 or 1086 or 38 U.S.C. 
613, in accordance with Sec. 489.25.
    (o) In the case of inpatient hospital services, to admit veterans 
whose admission has been authorized under 38 U.S.C. 603, in accordance 
with Sec. 489.26.
    (p) To comply with Sec. 489.27 of this part concerning notification 
of Medicare beneficiaries of their rights associated with the 
termination of Medicare services.
    (q) In the case of a hospital as defined in Sec. 489.24(b)--
    (1) To post conspicuously in any emergency department or in a place 
or places likely to be noticed by all individuals entering the emergency 
department, as well as those individuals waiting for examination and 
treatment in areas other than traditional emergency departments (that 
is, entrance, admitting area, waiting room, treatment area), a sign (in 
a form specified by the Secretary) specifying rights of individuals 
under Section 1867 of the Act with respect to examination and treatment 
for emergency medical conditions and women in labor; and
    (2) To post conspicuously (in a form specified by the Secretary) 
information indicating whether or not the hospital or rural primary care 
hospital participates in the Medicaid program under a State plan 
approved under title XIX.
    (r) In the case of a hospital as defined in Sec. 489.24(b) 
(including both the transferring and receiving hospitals), to maintain--
    (1) Medical and other records related to individuals transferred to 
or from the hospital for a period of 5 years from the date of the 
transfer;
    (2) An on-call list of physicians who are on the hospital's medical 
staff or who have privileges at the hospital, or who are on the staff or 
have privileges at another hospital participating in a formal community 
call plan, in accordance with Sec. 489.24(j)(2)(iii), available to 
provide treatment necessary after the initial examination to stabilize 
individuals with emergency medical conditions who are receiving services 
required under Sec. 489.24 in accordance with the resources available 
to the hospital; and
    (3) A central log on each individual who comes to the emergency 
department, as defined in Sec. 489.24(b), seeking assistance and 
whether he or she refused treatment, was refused treatment, or whether 
he or she was transferred, admitted and treated, stabilized and 
transferred, or discharged.
    (s) In the case of an SNF, either to furnish directly or make 
arrangements (as defined in Sec. 409.3 of this chapter) for all 
Medicare-covered services furnished to a resident (as defined in Sec. 
411.15(p)(3) of this chapter) of the SNF, except the following:
    (1) Physicians' services that meet the criteria of Sec. 415.102(a) 
of this chapter for payment on a fee schedule basis.
    (2) Services performed under a physician's supervision by a 
physician assistant who meets the applicable definition in section 
1861(aa)(5) of the Act.
    (3) Services performed by a nurse practitioner or clinical nurse 
specialist who meets the applicable definition in section 1861(aa)(5) of 
the Act and is working in collaboration (as defined in section 
1861(aa)(6) of the Act) with a physician.
    (4) Services performed by a certified nurse-midwife, as defined in 
section 1861(gg) of the Act.
    (5) Services performed by a qualified psychologist, as defined in 
section 1861(ii) of the Act.

[[Page 599]]

    (6) Services performed by a certified registered nurse anesthetist, 
as defined in section 1861(bb) of the Act.
    (7) Dialysis services and supplies, as defined in section 
1861(s)(2)(F) of the Act, and those ambulance services that are 
furnished in conjunction with them.
    (8) Erythropoietin (EPO) for dialysis patients, as defined in 
section 1861(s)(2)(O) of the Act.
    (9) Hospice care, as defined in section 1861(dd) of the Act.
    (10) An ambulance trip that initially conveys an individual to the 
SNF to be admitted as a resident, or that conveys an individual from the 
SNF in connection with one of the circumstances specified in Sec. 
411.15(p)(3)(i) through (p)(3)(iv) of this chapter as ending the 
individual's status as an SNF resident.
    (11) The transportation costs of electrocardiogram equipment (HCPCS 
code R0076), but only with respect to those electrocardiogram test 
services furnished during 1998.
    (12) Services described in paragraphs (s)(1) through (6) of this 
section when furnished via telehealth under section 
1834(m)(4)(C)(ii)(VII) of the Act.
    (13) Those chemotherapy items identified, as of July 1, 1999, by 
HCPCS codes J9000-J9020, J9040-J9151, J9170-J9185, J9200-J9201, J9206-
J9208, J9211, J9230-J9245, and J9265-J9600, and as of January 1, 2004, 
by HCPCS codes A9522, A9523, A9533, and A9534 (as subsequently modified 
by CMS), and any additional chemotherapy items identified by CMS.
    (14) Those chemotherapy administration services identified, as of 
July 1, 1999, by HCPCS codes 36260-36262, 36489, 36530-36535, 36640, 
36823, and 96405-96542 (as subsequently modified by CMS), and any 
additional chemotherapy administration services identified by CMS.
    (15) Those radioisotope services identified, as of July 1, 1999, by 
HCPCS codes 79030-79440 (as subsequently modified by CMS), and any 
additional radioisotope services identified by CMS.
    (16) Those customized prosthetic devices (including artificial limbs 
and their components) identified, as of July 1, 1999, by HCPCS codes 
L5050-L5340, L5500-L5611, L5613-L5986, L5988, L6050-L6370, L6400-6880, 
L6920-L7274, and L7362-L7366 (as subsequently modified by CMS) and any 
additional customized prosthetic devices identified by CMS, which are 
delivered for a resident's use during a stay in the SNF and intended to 
be used by the resident after discharge from the SNF.
    (17) Those blood clotting factors indicated for the treatment of 
patients with hemophilia and other bleeding disorders identified, as of 
July 1, 2020, by HCPCS codes J7170, J7175, J7177-J7183, J7185-J7190, 
J7192-J7195, J7198-J7203, J7205, and J7207-J7211 (as subsequently 
modified by CMS) and items and services related to the furnishing of 
such factors, and any additional blood clotting factors identified by 
CMS and items and services related to the furnishing of such factors.
    (18) Those RHC and FQHC services that are described in Sec. 
405.2411(b)(2) of this chapter.
    (t) Hospitals that are not otherwise subject to the Occupational 
Safety and Health Act of 1970 (or a State occupational safety and health 
plan that is approved under section 18(b) of the Occupational Safety and 
Health Act) must comply with the bloodborne pathogens (BBP) standards 
under 29 CFR 1910.1030. A hospital that fails to comply with the BBP 
standards may be subject to a civil money penalty in accordance with 
section 17 of the Occupational Safety and Health Act of 1970, including 
any adjustments of the civil money penalty amounts under the Federal 
Civil Penalties Inflation Adjustment Act, for a violation of the BBP 
standards. A civil money penalty will be imposed and collected in the 
same manner as civil money penalties under section 1128A(a) of the 
Social Security Act.
    (u) Except as provided in paragraph (v) of this section, in the case 
of a physician-owned hospital as defined at Sec. 489.3--
    (1) To furnish written notice to each patient at the beginning of 
the patient's hospital stay or outpatient visit that the hospital is a 
physician-owned hospital, in order to assist the patient in making an 
informed decision regarding his or her care, in accordance with

[[Page 600]]

Sec. 482.13(b)(2) of this subchapter. The notice should disclose, in a 
manner reasonably designed to be understood by all patients, the fact 
that the hospital meets the Federal definition of a physician-owned 
hospital specified in Sec. 489.3 and that the list of the hospital's 
owners or investors who are physicians or immediate family members (as 
defined at Sec. 411.351 of this chapter) of physicians is available 
upon request and must be provided to the patient at the time the request 
for the list is made by or on behalf of the patient. For purposes of 
this paragraph (u)(1), the hospital stay or outpatient visit begins with 
the provision of a package of information regarding scheduled 
preadmission testing and registration for a planned hospital admission 
for inpatient care or an outpatient service.
    (2) To require each physician who is a member of the hospital's 
medical staff to agree, as a condition of continued medical staff 
membership or admitting privileges, to disclose, in writing, to all 
patients the physician refers to the hospital any ownership or 
investment interest in the hospital that is held by the physician or by 
an immediate family member (as defined at Sec. 411.351 of this chapter) 
of the physician. Disclosure must be required at the time the referral 
is made.
    (v) The requirements of paragraph (u) of this section do not apply 
to any physician-owned hospital that does not have at least one 
referring physician (as defined at Sec. 411.351 of this chapter) who 
has an ownership or investment interest in the hospital or who has an 
immediate family member who has an ownership or investment interest in 
the hospital, provided that such hospital signs an attestation statement 
to that effect and maintains such attestation in its records.
    (w)(1) In the case of a hospital as defined in Sec. 489.24(b), to 
furnish written notice to all patients at the beginning of their planned 
or unplanned inpatient hospital stay or at the beginning of any planned 
or unplanned outpatient visit for observation, surgery or any other 
procedure requiring anesthesia, if a doctor of medicine or a doctor of 
osteopathy is not present in the hospital 24 hours per day, 7 days per 
week, in order to assist the patients in making informed decisions 
regarding their care, in accordance with Sec. 482.13(b)(2) of this 
subchapter. For purposes of this paragraph, a planned hospital stay or 
outpatient visit begins with the provision of a package of information 
regarding scheduled preadmission testing and registration for a planned 
hospital admission for inpatient care or outpatient service. An 
unplanned hospital stay or outpatient visit begins at the earliest point 
at which the patient presents to the hospital.
    (2) In the case of a hospital that is a main provider and has one or 
more remote locations of a hospital or one or more satellites, as these 
terms are defined in Sec. 413.65(a)(2), Sec. 412.22(h), or Sec. 
412.25(e) of this chapter, as applicable, the determination is made 
separately for the main provider and each remote location or satellite 
whether notice to patients is required. Notice is required at each 
location at which inpatient services are furnished at which a doctor of 
medicine or doctor of osteopathy is not present 24 hours per day, 7 days 
per week.
    (3) The written notice must state that the hospital does not have a 
doctor of medicine or a doctor of osteopathy present in the hospital 24 
hours per day, 7 days per week, and must indicate how the hospital will 
meet the medical needs of any patient who develops an emergency medical 
condition, as defined in Sec. 489.24(b), at a time when there is no 
doctor of medicine or doctor of osteopathy present in the hospital.
    (4) Before admitting a patient or providing an outpatient service to 
outpatients for whom a notice is required, the hospital must receive a 
signed acknowledgment from the patient stating that the patient 
understands that a doctor of medicine or doctor of osteopathy may not be 
present during all hours services are furnished to the patient.
    (5) Each dedicated emergency department, as that term is defined in 
Sec. 489.24(b), in a hospital in which a doctor of medicine or doctor 
of osteopathy is not present 24 hours per day, 7 days per week must post 
a notice conspicuously in a place or places likely to be noticed by all 
individuals entering the dedicated emergency department. The

[[Page 601]]

posted notice must state that the hospital does not have a doctor of 
medicine or a doctor of osteopathy present in the hospital 24 hours per 
day, 7 days per week, and must indicate how the hospital will meet the 
medical needs of any patient with an emergency medical condition, as 
defined in Sec. 489.24(b), at a time when there is no doctor of 
medicine or doctor of osteopathy present in the hospital.
    (x) To comply with Sec. 488.30 of this chapter, to pay revisit user 
fees when and if assessed.
    (y) In the case of a hospital or critical access hospital, to 
provide notice, as specified in paragraphs (y)(1) and (2) of this 
section, to each individual entitled to Medicare benefits under Title 
XVIII of the Act when such individual receives observation services as 
an outpatient for more than 24 hours. Notice must be provided to the 
individual not later than 36 hours after observation services are 
initiated or sooner if the individual is transferred, discharged, or 
admitted. Notice may be provided before such individual receives 24 
hours of observation services as an outpatient.
    (1) Written notice. Hospitals and critical access hospitals must use 
a standardized written notice, as specified by the Secretary, which 
includes the following information:
    (i) An explanation of the status of the individual as an outpatient 
receiving observation services and not as an inpatient of the hospital 
or critical access hospital and the reason for status as an outpatient 
receiving observation services; and
    (ii) An explanation of the implications of such status as an 
outpatient on services furnished by the hospital or critical access 
hospital (including services furnished on an inpatient basis), such as 
Medicare cost-sharing requirements, and subsequent eligibility for 
Medicare coverage for skilled nursing facility services.
    (2) Oral notice. The hospital must give an oral explanation of the 
written notification described in paragraph (y)(1) of this section.
    (3) Signature requirements. The written notice specified in 
paragraph (y)(1) of this section must either--
    (i) Be signed by the individual who receives observation services as 
an outpatient or a person acting on the individual's behalf to 
acknowledge receipt of such notification; or
    (ii) If the individual who receives observation services as an 
outpatient or the person acting on behalf of the individual refuses to 
provide the signature described in paragraph (y)(1) of this section, is 
signed by the staff member of the hospital or critical access hospital 
who presented the written notification and includes the name and title 
of the staff member, a certification that the notification was 
presented, and the date and time the notification was presented.

[45 FR 22937, Apr. 4, 1980]

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

    Effective Date Note: At 59 FR 32120, June 22, 1994, Sec. 489.20(l) 
through (r) were added. Paragraphs (m), (r)(2), and (r)(3) of this 
section contain information collection and recordkeeping requirements 
and will not become effective until approval has been given by the 
Office of Management and Budget.



Sec. 489.21  Specific limitations on charges.

    Except as specified in subpart C of this part, the provider agrees 
not to charge a beneficiary for any of the following:
    (a) Services for which the beneficiary is entitled to have payment 
made under Medicare.
    (b) Services for which the beneficiary would be entitled to have 
payment made if the provider--
    (1) Had in its files the required certification and recertification 
by a physician relating to the services furnished to the beneficiary;
    (2) Had furnished the information required by the intermediary in 
order to determine the amount due the provider on behalf of the 
individual for the period with respect to which payment is to be made or 
any prior period;
    (3) Had complied with the provisions requiring timely utilization 
review of long stay cases so that a limitation on days of service has 
not been imposed under section 1866(d) of the Act (see

[[Page 602]]

subpart K of part 405 and part 482 of this chapter for utilization 
review requirements); and
    (4) Had obtained, from the beneficiary or a person acting on his or 
her behalf, a written request for payment to be made to the provider, 
and had properly filed that request. (If the beneficiary or person on 
his or her behalf refuses to execute a written request, the provider may 
charge the beneficiary for all services furnished to him or her.)
    (c) Inpatient hospital services furnished to a beneficiary who 
exhausted his or her Part A benefits, if CMS reimburses the provider for 
those services.
    (d) Custodial care and services not reasonable and necessary for the 
diagnosis or treatment of illness or injury, if--
    (1) The beneficiary was without fault in incurring the expenses; and
    (2) The determination that payment was incorrect was not made until 
after the third year following the year in which the payment notice was 
sent to the beneficiary.
    (e) Inpatient hospital services for which a beneficiary would be 
entitled to have payment made under Part A of Medicare but for a denial 
or reduction in payments under regulations at Sec. 412.48 of this 
chapter or under section 1886(f) of the Act.
    (f) Items and services furnished to a hospital inpatient (other than 
physicians' services as described in Sec. 415.102(a) of this chapter or 
the services of an anesthetist as described in Sec. 405.553(b)(4) of 
this chapter) for which Medicare payment would be made if furnished by 
the hospital or by other providers or suppliers under arrangements made 
with them by the hospital. For this purpose, a charge by another 
provider or supplier for such an item or service is treated as a charge 
by the hospital for the item or service, and is also prohibited.
    (g) [Reserved]
    (h) Items and services (other than those described in Sec. 
489.20(s)(1) through (15)) required to be furnished under Sec. 
489.20(s) to a resident of an SNF (defined in Sec. 411.15(p) of this 
chapter), for which Medicare payment would be made if furnished by the 
SNF or by other providers or suppliers under arrangements made with them 
by the SNF. For this purpose, a charge by another provider or supplier 
for such an item or service is treated as a charge by the SNF for the 
item or service, and is also prohibited.

[49 FR 324, Jan. 3, 1984, as amended at 51 FR 22052, June 17, 1986; 52 
FR 27765, July 23, 1987; 60 FR 63189, Dec. 8, 1995; 64 FR 41683, July 
30, 1999; 65 FR 46796, July 31, 2000; 65 FR 62646, Oct. 19, 2000; 66 FR 
39601, July 31, 2001]



Sec. 489.22  Special provisions applicable to prepayment requirements.

    (a) A provider may not require an individual entitled to hospital 
insurance benefits to prepay in part or in whole for inpatient services 
as a condition of admittance as an inpatient, except where it is clear 
upon admission that payment under Medicare, Part A cannot be made.
    (b) A provider may not deny covered inpatient services to an 
individual entitled to have payment made for those services on the 
ground of inability or failure to pay a requested amount at or before 
admission.
    (c) A provider may not evict, or threaten to evict, an individual 
for inability to pay a deductible or a coinsurance amount required under 
Medicare.
    (d) A provider may not charge an individual for (1) its agreement to 
admit or readmit the individual on some specified future date for 
covered inpatient services; or (2) for failure to remain an inpatient 
for any agreed-upon length of time or for failure to give advance notice 
of departure from the provider's facilities.

[45 FR 22937, Apr. 4, 1980, as amended at 68 FR 46072, Aug. 4, 2003]



Sec. 489.23  Specific limitation on charges for services provided to 
certain enrollees of fee-for-service FEHB plans.

    A provider that furnishes inpatient hospital services to a retired 
Federal worker age 65 or older who is enrolled in a fee-for-service FEHB 
plan and who is not covered under Medicare Part A, must accept, as 
payment in full, an amount that approximates as closely as possible the 
Medicare inpatient hospital prospective payment system (PPS) rate 
established under part 412.

[[Page 603]]

The payment to the provider is composed of a payment from the FEHB plan 
and a payment from the enrollee. This combined payment approximates the 
Medicare PPS rate. The payment from the FEHB plan approximates, as 
closely as possible, the Medicare PPS rate minus any applicable enrollee 
deductible, coinsurance, or copayment amount. The payment from the 
enrollee is equal to the applicable deductible, coinsurance, or 
copayment amount.

[62 FR 56111, Oct. 29, 1997]



Sec. 489.24  Special responsibilities of Medicare hospitals in
emergency cases.

    (a) Applicability of provisions of this section. (1) In the case of 
a hospital that has an emergency department, if an individual (whether 
or not eligible for Medicare benefits and regardless of ability to pay) 
``comes to the emergency department'', as defined in paragraph (b) of 
this section, the hospital must--
    (i) Provide an appropriate medical screening examination within the 
capability of the hospital's emergency department, including ancillary 
services routinely available to the emergency department, to determine 
whether or not an emergency medical condition exists. The examination 
must be conducted by an individual(s) who is determined qualified by 
hospital bylaws or rules and regulations and who meets the requirements 
of Sec. 482.55 of this chapter concerning emergency services personnel 
and direction; and
    (ii) If an emergency medical condition is determined to exist, 
provide any necessary stabilizing treatment, as defined in paragraph (d) 
of this section, or an appropriate transfer as defined in paragraph (e) 
of this section. If the hospital admits the individual as an inpatient 
for further treatment, the hospital's obligation under this section 
ends, as specified in paragraph (d)(2) of this section.
    (2)(i) When a waiver has been issued in accordance with section 1135 
of the Act that includes a waiver under section 1135(b)(3) of the Act, 
sanctions under this section for an inappropriate transfer or for the 
direction or relocation of an individual to receive medical screening at 
an alternate location do not apply to a hospital with a dedicated 
emergency department if the following conditions are met:
    (A) The transfer is necessitated by the circumstances of the 
declared emergency in the emergency area during the emergency period.
    (B) The direction or relocation of an individual to receive medical 
screening at an alternate location is pursuant to an appropriate State 
emergency preparedness plan or, in the case of a public health emergency 
that involves a pandemic infectious disease, pursuant to a State 
pandemic preparedness plan.
    (C) The hospital does not discriminate on the basis of an 
individual's source of payment or ability to pay.
    (D) The hospital is located in an emergency area during an emergency 
period, as those terms are defined in section 1135(g)(1) of the Act.
    (E) There has been a determination that a waiver of sanctions is 
necessary.
    (ii) A waiver of these sanctions is limited to a 72-hour period 
beginning upon the implementation of a hospital disaster protocol, 
except that, if a public health emergency involves a pandemic infectious 
disease (such as pandemic influenza), the waiver will continue in effect 
until the termination of the applicable declaration of a public health 
emergency, as provided under section 1135(e)(1)(B) of the Act.
    (b) Definitions. As used in this subpart--
    Capacity means the ability of the hospital to accommodate the 
individual requesting examination or treatment of the transferred 
individual. Capacity encompasses such things as numbers and availability 
of qualified staff, beds and equipment and the hospital's past practices 
of accommodating additional patients in excess of its occupancy limits.
    Comes to the emergency department means, with respect to an 
individual who is not a patient (as defined in this section), the 
individual--
    (1) Has presented at a hospital's dedicated emergency department, as 
defined in this section, and requests examination or treatment for a 
medical condition, or has such a request made on his or her behalf. In 
the absence of such a request by or on behalf of the

[[Page 604]]

individual, a request on behalf of the individual will be considered to 
exist if a prudent layperson observer would believe, based on the 
individual's appearance or behavior, that the individual needs 
examination or treatment for a medical condition;
    (2) Has presented on hospital property, as defined in this section, 
other than the dedicated emergency department, and requests examination 
or treatment for what may be an emergency medical condition, or has such 
a request made on his or her behalf. In the absence of such a request by 
or on behalf of the individual, a request on behalf of the individual 
will be considered to exist if a prudent layperson observer would 
believe, based on the individual's appearance or behavior, that the 
individual needs emergency examination or treatment;
    (3) Is in a ground or air ambulance owned and operated by the 
hospital for purposes of examination and treatment for a medical 
condition at a hospital's dedicated emergency department, even if the 
ambulance is not on hospital grounds. However, an individual in an 
ambulance owned and operated by the hospital is not considered to have 
``come to the hospital's emergency department'' if--
    (i) The ambulance is operated under communitywide emergency medical 
service (EMS) protocols that direct it to transport the individual to a 
hospital other than the hospital that owns the ambulance; for example, 
to the closest appropriate facility. In this case, the individual is 
considered to have come to the emergency department of the hospital to 
which the individual is transported, at the time the individual is 
brought onto hospital property;
    (ii) The ambulance is operated at the direction of a physician who 
is not employed or otherwise affiliated with the hospital that owns the 
ambulance; or
    (4) Is in a ground or air nonhospital-owned ambulance on hospital 
property for presentation for examination and treatment for a medical 
condition at a hospital's dedicated emergency department. However, an 
individual in a nonhospital-owned ambulance off hospital property is not 
considered to have come to the hospital's emergency department, even if 
a member of the ambulance staff contacts the hospital by telephone or 
telemetry communications and informs the hospital that they want to 
transport the individual to the hospital for examination and treatment. 
The hospital may direct the ambulance to another facility if it is in 
``diversionary status,'' that is, it does not have the staff or 
facilities to accept any additional emergency patients. If, however, the 
ambulance staff disregards the hospital's diversion instructions and 
transports the individual onto hospital property, the individual is 
considered to have come to the emergency department.
    Dedicated emergency department means any department or facility of 
the hospital, regardless of whether it is located on or off the main 
hospital campus, that meets at least one of the following requirements:
    (1) It is licensed by the State in which it is located under 
applicable State law as an emergency room or emergency department;
    (2) It is held out to the public (by name, posted signs, 
advertising, or other means) as a place that provides care for emergency 
medical conditions on an urgent basis without requiring a previously 
scheduled appointment; or
    (3) During the calendar year immediately preceding the calendar year 
in which a determination under this section is being made, based on a 
representative sample of patient visits that occurred during that 
calendar year, it provides at least one-third of all of its outpatient 
visits for the treatment of emergency medical conditions on an urgent 
basis without requiring a previously scheduled appointment.
    Emergency medical condition means--
    (1) A medical condition manifesting itself by acute symptoms of 
sufficient severity (including severe pain, psychiatric disturbances 
and/or symptoms of substance abuse) such that the absence of immediate 
medical attention could reasonably be expected to result in--
    (i) Placing the health of the individual (or, with respect to a 
pregnant woman, the health of the woman or her unborn child) in serious 
jeopardy;
    (ii) Serious impairment to bodily functions; or

[[Page 605]]

    (iii) Serious dysfunction of any bodily organ or part; or
    (2) With respect to a pregnant woman who is having contractions--
    (i) That there is inadequate time to effect a safe transfer to 
another hospital before delivery; or
    (ii) That transfer may pose a threat to the health or safety of the 
woman or the unborn child.
    Hospital includes a critical access hospital as defined in section 
1861(mm)(1) of the Act.
    Hospital property means the entire main hospital campus as defined 
in Sec. 413.65(b) of this chapter, including the parking lot, sidewalk, 
and driveway, but excluding other areas or structures of the hospital's 
main building that are not part of the hospital, such as physician 
offices, rural health centers, skilled nursing facilities, or other 
entities that participate separately under Medicare, or restaurants, 
shops, or other nonmedical facilities.
    Hospital with an emergency department means a hospital with a 
dedicated emergency department as defined in this paragraph (b).
    Inpatient means an individual who is admitted to a hospital for bed 
occupancy for purposes of receiving inpatient hospital services as 
described in Sec. 409.10(a) of this chapter with the expectation that 
he or she will remain at least overnight and occupy a bed even though 
the situation later develops that the individual can be discharged or 
transferred to another hospital and does not actually use a hospital bed 
overnight.
    Labor means the process of childbirth beginning with the latent or 
early phase of labor and continuing through the delivery of the 
placenta. A woman experiencing contractions is in true labor unless a 
physician, certified nurse-midwife, or other qualified medical person 
acting within his or her scope of practice as defined in hospital 
medical staff bylaws and State law, certifies that, after a reasonable 
time of observation, the woman is in false labor.
    Participating hospital means (1) a hospital or (2) a critical access 
hospital as defined in section 1861(mm)(1) of the Act that has entered 
into a Medicare
provider agreement under section 1866 of the Act.
    Patient means--
    (1) An individual who has begun to receive outpatient services as 
part of an encounter, as defined in Sec. 410.2 of this chapter, other 
than an encounter that the hospital is obligated by this section to 
provide;
    (2) An individual who has been admitted as an inpatient, as defined 
in this section.
    Stabilized means, with respect to an ``emergency medical condition'' 
as defined in this section under paragraph (1) of that definition, that 
no material deterioration of the condition is likely, within reasonable 
medical probability, to result from or occur during the transfer of the 
individual from a facility or, with respect to an ``emergency medical 
condition'' as defined in this section under paragraph (2) of that 
definition, that the woman has delivered the child and the placenta.
    To stabilize means, with respect to an ``emergency medical 
condition'' as defined in this section under paragraph (1) of that 
definition, to provide such medical treatment of the condition necessary 
to assure, within reasonable medical probability, that no material 
deterioration of the condition is likely to result from or occur during 
the transfer of the individual from a facility or that, with respect to 
an ``emergency medical condition'' as defined in this section under 
paragraph (2) of that definition, the woman has delivered the child and 
the placenta.
    Transfer means the movement (including the discharge) of an 
individual outside a hospital's facilities at the direction of any 
person employed by (or affiliated or associated, directly or indirectly, 
with) the hospital, but does not include such a movement of an 
individual who (i) has been declared dead, or (ii) leaves the facility 
without the permission of any such person.
    (c) Use of dedicated emergency department for nonemergency services. 
If an individual comes to a hospital's dedicated emergency department 
and a request is made on his or her behalf for examination or treatment 
for a medical condition, but the nature of the request makes it clear 
that the medical

[[Page 606]]

condition is not of an emergency nature, the hospital is required only 
to perform such screening as would be appropriate for any individual 
presenting in that manner, to determine that the individual does not 
have an emergency medical condition.
    (d) Necessary stabilizing treatment for emergency medical 
conditions--(1) General. Subject to the provisions of paragraph (d)(2) 
of this section, if any individual (whether or not eligible for Medicare 
benefits) comes to a hospital and the hospital determines that the 
individual has an emergency medical condition, the hospital must provide 
either--
    (i) Within the capabilities of the staff and facilities available at 
the hospital, for further medical examination and treatment as required 
to stabilize the medical condition.
    (ii) For transfer of the individual to another medical facility in 
accordance with paragraph (e) of this section.
    (2) Exception: Application to inpatients. (i) If a hospital has 
screened an individual under paragraph (a) of this section and found the 
individual to have an emergency medical condition, and admits that 
individual as an inpatient in good faith in order to stabilize the 
emergency medical condition, the hospital has satisfied its special 
responsibilities under this section with respect to that individual.
    (ii) This section is not applicable to an inpatient who was admitted 
for elective (nonemergency) diagnosis or treatment.
    (iii) A hospital is required by the conditions of participation for 
hospitals under part 482 of this chapter to provide care to its 
inpatients in accordance with those conditions of participation.
    (3) Refusal to consent to treatment. A hospital meets the 
requirements of paragraph (d)(1)(i) of this section with respect to an 
individual if the hospital offers the individual the further medical 
examination and treatment described in that paragraph and informs the 
individual (or a person acting on the individual's behalf) of the risks 
and benefits to the individual of the examination and treatment, but the 
individual (or a person acting on the individual's behalf) does not 
consent to the examination or treatment. The medical record must contain 
a description of the examination, treatment, or both if applicable, that 
was refused by or on behalf of the individual. The hospital must take 
all reasonable steps to secure the individual's written informed refusal 
(or that of the person acting on his or her behalf). The written 
document should indicate that the person has been informed of the risks 
and benefits of the examination or treatment, or both.
    (4) Delay in examination or treatment. (i) A participating hospital 
may not delay providing an appropriate medical screening examination 
required under paragraph (a) of this section or further medical 
examination and treatment required under paragraph (d)(1) of this 
section in order to inquire about the individual's method of payment or 
insurance status.
    (ii) A participating hospital may not seek, or direct an individual 
to seek, authorization from the individual's insurance company for 
screening or stabilization services to be furnished by a hospital, 
physician, or nonphysician practitioner to an individual until after the 
hospital has provided the appropriate medical screening examination 
required under paragraph (a) of this section, and initiated any further 
medical examination and treatment that may be required to stabilize the 
emergency medical condition under paragraph (d)(1) of this section.
    (iii) An emergency physician or nonphysician practitioner is not 
precluded from contacting the individual's physician at any time to seek 
advice regarding the individual's medical history and needs that may be 
relevant to the medical treatment and screening of the patient, as long 
as this consultation does not inappropriately delay services required 
under paragraph (a) or paragraphs (d)(1) and (d)(2) of this section.
    (iv) Hospitals may follow reasonable registration processes for 
individuals for whom examination or treatment is required by this 
section, including asking whether an individual is insured and, if so, 
what that insurance is, as long as that inquiry does not delay screening 
or treatment. Reasonable registration processes may not unduly

[[Page 607]]

discourage individuals from remaining for further evaluation.
    (5) Refusal to consent to transfer. A hospital meets the 
requirements of paragraph (d)(1)(ii) of this section with respect to an 
individual if the hospital offers to transfer the individual to another 
medical facility in accordance with paragraph (e) of this section and 
informs the individual (or a person acting on his or her behalf) of the 
risks and benefits to the individual of the transfer, but the individual 
(or a person acting on the individual's behalf) does not consent to the 
transfer. The hospital must take all reasonable steps to secure the 
individual's written informed refusal (or that of a person acting on his 
or her behalf). The written document must indicate the person has been 
informed of the risks and benefits of the transfer and state the reasons 
for the individual's refusal. The medical record must contain a 
description of the proposed transfer that was refused by or on behalf of 
the individual.
    (e) Restricting transfer until the individual is stabilized--(1) 
General. If an individual at a hospital has an emergency medical 
condition that has not been stabilized (as defined in paragraph (b) of 
this section), the hospital may not transfer the individual unless--
    (i) The transfer is an appropriate transfer (within the meaning of 
paragraph (e)(2) of this section); and
    (ii)(A) The individual (or a legally responsible person acting on 
the individual's behalf) requests the transfer, after being informed of 
the hospital's obligations under this section and of the risk of 
transfer. The request must be in writing and indicate the reasons for 
the request as well as indicate that he or she is aware of the risks and 
benefits of the transfer;
    (B) A physician (within the meaning of section 1861(r)(1) of the 
Act) has signed a certification that, based upon the information 
available at the time of transfer, the medical benefits reasonably 
expected from the provision of appropriate medical treatment at another 
medical facility outweigh the increased risks to the individual or, in 
the case of a woman in labor, to the woman or the unborn child, from 
being transferred. The certification must contain a summary of the risks 
and benefits upon which it is based; or
    (C) If a physician is not physically present in the emergency 
department at the time an individual is transferred, a qualified medical 
person (as determined by the hospital in its by-laws or rules and 
regulations) has signed a certification described in paragraph 
(e)(1)(ii)(B) of this section after a physician (as defined in section 
1861(r)(1) of the Act) in consultation with the qualified medical 
person, agrees with the certification and subsequently countersigns the 
certification. The certification must contain a summary of the risks and 
benefits upon which it is based.
    (2) A transfer to another medical facility will be appropriate only 
in those cases in which--
    (i) The transferring hospital provides medical treatment within its 
capacity that minimizes the risks to the individual's health and, in the 
case of a woman in labor, the health of the unborn child;
    (ii) The receiving facility--
    (A) Has available space and qualified personnel for the treatment of 
the individual; and
    (B) Has agreed to accept transfer of the individual and to provide 
appropriate medical treatment;
    (iii) The transferring hospital sends to the receiving facility all 
medical records (or copies thereof) related to the emergency condition 
which the individual has presented that are available at the time of the 
transfer, including available history, records related to the 
individual's emergency medical condition, observations of signs or 
symptoms, preliminary diagnosis, results of diagnostic studies or 
telephone reports of the studies, treatment provided, results of any 
tests and the informed written consent or certification (or copy 
thereof) required under paragraph (e)(1)(ii) of this section, and the 
name and address of any on-call physician (described in paragraph (g) of 
this section) who has refused or failed to appear within a reasonable 
time to provide necessary stabilizing treatment. Other records (e.g., 
test results not yet available or historical records not readily 
available from the hospital's

[[Page 608]]

files) must be sent as soon as practicable after transfer; and
    (iv) The transfer is effected through qualified personnel and 
transportation equipment, as required, including the use of necessary 
and medically appropriate life support measures during the transfer.
    (3) A participating hospital may not penalize or take adverse action 
against a physician or a qualified medical person described in paragraph 
(e)(1)(ii)(C) of this section because the physician or qualified medical 
person refuses to authorize the transfer of an individual with an 
emergency medical condition that has not been stabilized, or against any 
hospital employee because the employee reports a violation of a 
requirement of this section.
    (f) Recipient hospital responsibilities. A participating hospital 
that has specialized capabilities or facilities (including, but not 
limited to, facilities such as burn units, shock-trauma units, neonatal 
intensive case units, or, with respect to rural areas, regional referral 
centers (which, for purposes of this subpart, mean hospitals meeting the 
requirements of referral centers found at Sec. 412.96 of this chapter)) 
may not refuse to accept from a referring hospital within the boundaries 
of the United States an appropriate transfer of an individual who 
requires such specialized capabilities or facilities if the receiving 
hospital has the capacity to treat the individual.
    (1) The provisions of this paragraph (f) apply to any participating 
hospital with specialized capabilities, regardless of whether the 
hospital has a dedicated emergency department.
    (2) The provisions of this paragraph (f) do not apply to an 
individual who has been admitted to a referring hospital under the 
provisions of paragraph (d)(2)(i) of this section.
    (g) Termination of provider agreement. If a hospital fails to meet 
the requirements of paragraph (a) through (f) of this section, CMS may 
terminate the provider agreement in accordance with Sec. 489.53.
    (h) Consultation with Quality Improvement Organizations (QIOs)--(1) 
General. Except as provided in paragraph (h)(3) of this section, in 
cases where a medical opinion is necessary to determine a physician's or 
hospital's liability under section 1867(d)(1) of the Act, CMS requests 
the appropriate QIO (with a contract under Part B of title XI of the 
Act) to review the alleged section 1867(d) violation and provide a 
report on its findings in accordance with paragraph (h)(2)(iv) and (v) 
of this section. CMS provides to the QIO all information relevant to the 
case and within its possession or control. CMS, in consultation with the 
OIG, also provides to the QIO a list of relevant questions to which the 
QIO must respond in its report.
    (2) Notice of review and opportunity for discussion and additional 
information. The QIO shall provide the physician and hospital reasonable 
notice of its review, a reasonable opportunity for discussion, and an 
opportunity for the physician and hospital to submit additional 
information before issuing its report. When a QIO receives a request for 
consultation under paragraph (h)(1) of this section, the following 
provisions apply--
    (i) The QIO reviews the case before the 15th calendar day and makes 
its tentative findings.
    (ii) Within 15 calendar days of receiving the case, the QIO gives 
written notice, sent by certified mail, return receipt requested, to the 
physician or the hospital (or both if applicable).
    (iii)(A) The written notice must contain the following information:
    (1) The name of each individual who may have been the subject of the 
alleged violation.
    (2) The date on which each alleged violation occurred.
    (3) An invitation to meet, either by telephone or in person, to 
discuss the case with the QIO, and to submit additional information to 
the QIO within 30 calendar days of receipt of the notice, and a 
statement that these rights will be waived if the invitation is not 
accepted. The QIO must receive the information and hold the meeting 
within the 30-day period.
    (4) A copy of the regulations at 42 CFR 489.24.
    (B) For purposes of paragraph (h)(2)(iii)(A) of this section, the 
date of receipt is presumed to be 5 days after the certified mail date 
on the notice,

[[Page 609]]

unless there is a reasonable showing to the contrary.
    (iv) The physician or hospital (or both where applicable) may 
request a meeting with the QIO. This meeting is not designed to be a 
formal adversarial hearing or a mechanism for discovery by the physician 
or hospital. The meeting is intended to afford the physician and/or the 
hospital a full and fair opportunity to present the views of the 
physician and/or hospital regarding the case. The following provisions 
apply to that meeting:
    (A) The physician and/or hospital has the right to have legal 
counsel present during that meeting. However, the QIO may control the 
scope, extent, and manner of any questioning or any other presentation 
by the attorney. The QIO may also have legal counsel present.
    (B) The QIO makes arrangements so that, if requested by CMS or the 
OIG, a verbatim transcript of the meeting may be generated. If CMS or 
OIG requests a transcript, the affected physician and/or the affected 
hospital may request that CMS provide a copy of the transcript.
    (C) The QIO affords the physician and/or the hospital an opportunity 
to present, with the assistance of counsel, expert testimony in either 
oral or written form on the medical issues presented. However, the QIO 
may reasonably limit the number of witnesses and length of such 
testimony if such testimony is irrelevant or repetitive. The physician 
and/or hospital, directly or through counsel, may disclose patient 
records to potential expert witnesses without violating any non-
disclosure requirements set forth in part 476 of this chapter.
    (D) The QIO is not obligated to consider any additional information 
provided by the physician and/or the hospital after the meeting, unless, 
before the end of the meeting, the QIO requests that the physician and/
or hospital submit additional information to support the claims. The QIO 
then allows the physician and/or the hospital an additional period of 
time, not to exceed 5 calendar days from the meeting, to submit the 
relevant information to the QIO.
    (v) Within 60 calendar days of receiving the case, the QIO must 
submit to CMS a report on the QIO's findings. CMS provides copies to the 
OIG and to the affected physician and/or the affected hospital. The 
report must contain the name of the physician and/or the hospital, the 
name of the individual, and the dates and times the individual arrived 
at and was transferred (or discharged) from the hospital. The report 
provides expert medical opinion regarding whether the individual 
involved had an emergency medical condition, whether the individual's 
emergency medical condition was stabilized, whether the individual was 
transferred appropriately, and whether there were any medical 
utilization or quality of care issues involved in the case.
    (vi) The report required under paragraph (h)(2)(v) of this section 
should not state an opinion or conclusion as to whether section 1867 of 
the Act or Sec. 489.24 has been violated.
    (3) If a delay would jeopardize the health or safety of individuals 
or when there was no screening examination, the QIO review described in 
this section is not required before the OIG may impose civil monetary 
penalties or an exclusion in accordance with section 1867(d)(1) of the 
Act and 42 CFR part 1003 of this title.
    (4) If the QIO determines after a preliminary review that there was 
an appropriate medical screening examination and the individual did not 
have an emergency medical condition, as defined by paragraph (b) of this 
section, then the QIO may, at its discretion, return the case to CMS and 
not meet the requirements of paragraph (h) except for those in paragraph 
(h)(2)(v).
    (i) Release of QIO assessments. Upon request, CMS may release a QIO 
assessment to the physician and/or hospital, or the affected individual, 
or his or her representative. The QIO physician's identity is 
confidential unless he or she consents to its release. (See Sec. Sec. 
476.132 and 476.133 of this chapter.)
    (j) Availability of on-call physicians. In accordance with the on-
call list requirements specified in Sec. 489.20(r)(2), a hospital must 
have written policies and procedures in place--
    (1) To respond to situations in which a particular specialty is not 
available

[[Page 610]]

or the on-call physician cannot respond because of circumstances beyond 
the physician's control; and
    (2) To provide that emergency services are available to meet the 
needs of individuals with emergency medical conditions if a hospital 
elects to--
    (i) Permit on-call physicians to schedule elective surgery during 
the time that they are on call;
    (ii) Permit on-call physicians to have simultaneous on-call duties; 
and
    (iii) Participate in a formal community call plan. Notwithstanding 
participation in a community call plan, hospitals are still required to 
perform medical screening examinations on individuals who present 
seeking treatment and to conduct appropriate transfers. The formal 
community plan must include the following elements:
    (A) A clear delineation of on-call coverage responsibilities; that 
is, when each hospital participating in the plan is responsible for on-
call coverage.
    (B) A description of the specific geographic area to which the plan 
applies.
    (C) A signature by an appropriate representative of each hospital 
participating in the plan.
    (D) Assurances that any local and regional EMS system protocol 
formally includes information on community on-call arrangements.
    (E) A statement specifying that even if an individual arrives at a 
hospital that is not designated as the on-call hospital, that hospital 
still has an obligation under Sec. 489.24 to provide a medical 
screening examination and stabilizing treatment within its capability, 
and that hospitals participating in the community call plan must abide 
by the regulations under Sec. 489.24 governing appropriate transfers.
    (F) An annual assessment of the community call plan by the 
participating hospitals.

[59 FR 32120, June 22, 1994, as amended at 62 FR 46037, Aug. 29, 1997; 
65 FR 18548, Apr. 7, 2000; 65 FR 59748, Oct. 6, 2000; 66 FR 1599, Jan. 
9, 2001; 66 FR 59923, Nov. 30, 2001; 68 FR 53262, Sept. 9, 2003; 71 FR 
48143, Aug. 18, 2006; 72 FR 47413, Aug. 22, 2007; 73 FR 48758, Aug. 19, 
2008; 74 FR 44001, Aug. 27, 2009; 78 FR 50971, Aug. 19, 2013]

    Effective Date Note: At 59 FR 32120, June 22, 1994, Sec. 489.24 was 
added. Paragraphs (d) and (g) of this section contain information 
collection and recordkeeping requirements and will not become effective 
until approval has been given by the Office of Management and Budget.



Sec. 489.25  Special requirements concerning CHAMPUS and CHAMPVA
programs.

    For inpatient services, a hospital that participates in the Medicare 
program must participate in any health plan contracted under 10 U.S.C. 
1079 or 1086 (Civilian Health and Medical Program of the Uniformed 
Services) and under 38 U.S.C. 613 (Civilian Health and Medical Program 
of the Veterans Administration) and accept the CHAMPUS/CHAMPVA-
determined allowable amount as payment in full, less applicable 
deductible, patient cost-share, and noncovered items. Hospitals must 
meet the requirements of 32 CFR part 199 concerning program benefits 
under the Department of Defense. This section applies to inpatient 
services furnished to beneficiaries admitted on or after January 1, 
1987.

[59 FR 32123, June 22, 1994]



Sec. 489.26  Special requirements concerning veterans.

    For inpatient services, a hospital that participates in the Medicare 
program must admit any veteran whose admission is authorized by the 
Department of Veterans Affairs under 38 U.S.C. 603 and must meet the 
requirements of 38 CFR part 17 concerning admissions practices and 
payment methodology and amounts. This section applies to services 
furnished to veterans admitted on and after July 1, 1987.

[59 FR 32123, June 22, 1994]



Sec. 489.27  Beneficiary notice of discharge rights.

    (a) A hospital that participates in the Medicare program must 
furnish each Medicare beneficiary or enrollee, (or an individual acting 
on his or her behalf), timely notice as required by section 
1866(A)(1)(M) of the Act and in accordance with Sec. 405.1205 and Sec. 
422.620. The hospital must be able to demonstrate compliance with this 
requirement.
    (b) Notification by hospitals and other providers. Hospitals and 
other providers

[[Page 611]]

(as identified at 489.2(b)) that participate in the Medicare program 
must furnish each Medicare beneficiary, or representative, applicable 
CMS notices in advance of discharge or termination of Medicare services, 
including the notices required under Sec. 405.1200, Sec. 405.1202, 
Sec. 405.1206, and Sec. 422.624 of this chapter.

[71 FR 68724, Nov. 27, 2006]



Sec. 489.28  Special capitalization requirements for HHAs.

    (a) Basic rule. An HHA entering the Medicare program on or after 
January 1, 1998, including a new HHA as a result of a change of 
ownership, if the change of ownership results in a new provider number 
being issued, must have available sufficient funds, which we term 
``initial reserve operating funds,'' at the time of application 
submission and at all times during the enrollment process up to the 
expiration of the 3-month period following the conveyance of Medicare 
billing privileges to operate the HHA for the three-month period after 
Medicare billing privileges are conveyed by the Medicare contractor, 
exclusive of actual or projected accounts receivable from Medicare.
    (b) Standard. Initial reserve operating funds are sufficient to meet 
the requirement of this section if the total amount of such funds is 
equal to or greater than the product of the actual average cost per 
visit of three or more similarly situated HHAs in their first year of 
operation (selected by CMS for comparative purposes) multiplied by the 
number of visits projected by the HHA for its first three months of 
operation--or 22.5 percent (one fourth of 90 percent) of the average 
number of visits reported by the comparison HHAs--whichever is greater.
    (c) Method. CMS, through the intermediary, will determine the amount 
of the initial reserve operating funds using reported cost and visit 
data from submitted cost reports for the first full year of operation 
from at least three HHAs that the intermediary serves that are 
comparable to the HHA that is seeking to enter the Medicare program, 
considering such factors as geographic location and urban/rural status, 
number of visits, provider-based versus free-standing, and proprietary 
versus non-proprietary status. The determination of the adequacy of the 
required initial reserve operating funds is based on the average cost 
per visit of the comparable HHAs, by dividing the sum of total reported 
costs of the HHAs in their first year of operation by the sum of the 
HHAs' total reported visits. The resulting average cost per visit is 
then multiplied by the projected visits for the first three months of 
operation of the HHA seeking to enter the program, but not less than 90 
percent of average visits for a three month period for the HHAs used in 
determining the average cost per visit.
    (1) In selecting the comparative HHAs as described in this paragraph 
(c), the CMS contractor shall only select HHAs that have provided cost 
reports to Medicare. When selecting cost reports for the comparative 
analysis, CMS will exclude low utilization or no utilization cost 
reports.
    (2) [Reserved]
    (d) Required proof of availability of initial reserve operating 
funds. The HHA must provide CMS with adequate proof of the availability 
of initial reserve operating funds. Such proof, at a minimum, will 
include a copy of the statement(s) of the HHA's savings, checking, or 
other account(s) that contains the funds, accompanied by an attestation 
from an officer of the bank or other financial institution that the 
funds are in the account(s) and that the funds are immediately available 
to the HHA. In some cases, an HHA may have all or part of the initial 
reserve operating funds in cash equivalents. For the purpose of this 
section, cash equivalents are short-term, highly liquid investments that 
are readily convertible to known amounts of cash and that present 
insignificant risk of changes in value. A cash equivalent that is not 
readily convertible to a known amount of cash as needed during the 
initial three month period for which the initial reserve operating funds 
are required does not qualify in meeting the initial reserve operating 
funds requirement. Examples of cash equivalents for the purpose of this 
section are Treasury bills, commercial paper, and money market funds. As 
with funds in a checking, savings, or other account, the HHA also must 
be

[[Page 612]]

able to document the availability of any cash equivalents. CMS later may 
require the HHA to furnish another attestation from the financial 
institution that the funds remain available, or, if applicable, 
documentation from the HHA that any cash equivalents remain available, 
until a date when the HHA will have been surveyed by the State agency or 
by an approved accrediting organization. The officer of the HHA who will 
be certifying the accuracy of the information on the HHA's cost report 
must certify what portion of the required initial reserve operating 
funds is non-borrowed funds, including funds invested in the business by 
the owner. That amount must be at least 50 percent of the required 
initial reserve operating funds. The remainder of the reserve operating 
funds may be secured through borrowing or line of credit from an 
unrelated lender.
    (e) Borrowed funds. If borrowed funds are not in the same account(s) 
as the HHA's own non-borrowed funds, the HHA also must provide proof 
that the borrowed funds are available for use in operating the HHA, by 
providing, at a minimum, a copy of the statement(s) of the HHA's 
savings, checking, or other account(s) containing the borrowed funds, 
accompanied by an attestation from an officer of the bank or other 
financial institution that the funds are in the account(s) and are 
immediately available to the HHA. As with the HHA's own (that is, non-
borrowed) funds, CMS later may require the HHA to establish the current 
availability of such borrowed funds, including furnishing an attestation 
from a financial institution or other source, as may be appropriate, and 
to establish that such funds will remain available until a date when the 
HHA will have been surveyed by the State agency or by an approved 
accrediting organization.
    (f) Line of credit. If the HHA chooses to support the availability 
of a portion of the initial reserve operating funds with a line of 
credit, it must provide CMS with a letter of credit from the lender. CMS 
later may require the HHA to furnish an attestation from the lender that 
the HHA, upon its certification into the Medicare program, continues to 
be approved to borrow the amount specified in the letter of credit.
    (g) Billing Privileges. (1) CMS may deny Medicare billing privileges 
to an HHA unless the HHA meets the initial reserve operating funds 
requirements of this section.
    (2) CMS may revoke the Medicare billing privileges of an HHA that 
fails to maintain and comply with the initial reserve operating funds 
requirements of this section for the three-month period after it 
receives its Medicare billing privileges.

[63 FR 312, Jan. 5, 1998, as amended at 75 FR 70465, Nov. 17, 2010]



Sec. 489.29  Special requirements concerning beneficiaries served
by the Indian Health Service, Tribal health programs, and urban
Indian organization health programs.
          

    (a) Hospitals (as defined in sections 1861(e) and (f) of the Social 
Security Act) and critical access hospitals (as defined in section 
1861(mm)(1) of the Social Security Act) that participate in the Medicare 
program and furnish inpatient hospital services must accept the payment 
methodology and no more than the rates of payment established under 42 
CFR part 136, subpart D as payment in full for the following programs:
    (1) A contract health service (CHS) program under 42 CFR part 136, 
subpart C, of the Indian Health Service (IHS);
    (2) A CHS program under 42 CFR part 136, subpart C, carried out by 
an Indian Tribe or Tribal organization pursuant to the Indian Self-
Determination and Education Assistance Act, as amended, Public Law 93-
638, 25 U.S.C. 450 et seq.; and
    (3) A program funded through a grant or contract by the IHS and 
operated by an urban Indian organization under which items and services 
are purchased for an eligible urban Indian (as those terms are defined 
in 25 U.S.C. 1603 (f) and (h)).
    (b) Hospitals and critical access hospitals may not refuse service 
to an individual on the basis that the payment for such service is 
authorized under programs described in paragraph (a) of this section.

[72 FR 30711, June 4, 2007]

[[Page 613]]



                       Subpart C_Allowable Charges



Sec. 489.30  Allowable charges: Deductibles and coinsurance.

    (a) Part A deductible and coinsurance. The provider may charge the 
beneficiary or other person on his or her behalf:
    (1) The amount of the inpatient hospital deductible or, if less, the 
actual charges for the services;
    (2) The amount of inpatient hospital coinsurance applicable for each 
day the individual is furnished inpatient hospital services after the 
60th day, during a benefit period; and
    (3) The posthospital SNF care coinsurance amount.
    (4) In the case of durable medical equipment (DME) furnished as a 
home health service, 20 percent of the customary charge for the service.
    (b) Part B deductible and coinsurance. (1) The basic allowable 
charges are the $75 deductible and 20 percent of the customary (insofar 
as reasonable) charges in excess of that deductible.
    (2) For hospital outpatient services, the allowable deductible 
charges depend on whether the hospital can determine the beneficiary's 
deductible status.
    (i) If the hospital is unable to determine the deductible status, it 
may charge the beneficiary its full customary charges up to $75.
    (ii) If the beneficiary provides official information as to 
deductible status, the hospital may charge only the unmet portion of the 
deductible.
    (3) In either of the cases discussed in paragraph (b)(2) of this 
section, the hospital is required to file with the intermediary, on a 
form prescribed by CMS, information as to the services, charges, and 
amounts collected.
    (4) The intermediary must reimburse the beneficiary if reimbursement 
is authorized and credit the expenses to the beneficiary's deductible if 
the deductible has not yet been met.
    (5) In the case of DME furnished as a home health service under 
Medicare Part B, the coinsurance is 20 percent of the customary (insofar 
as reasonable) charge for the services, with the following exception: If 
the DME is used DME purchased by or on behalf of the beneficiary at a 
price at least 25 percent less than the reasonable charge for comparable 
new equipment, no coinsurance is required.

[45 FR 22937, Apr. 4, 1980, as amended at 51 FR 41350, Nov. 14, 1986]



Sec. 489.31  Allowable charges: Blood.

    (a) Limitations on charges. (1) A provider may charge the 
beneficiary (or other person on his or her behalf) only for the first 
three pints of blood or units of packed red cells furnished under 
Medicare Part A during a calendar year, or furnished under Medicare Part 
B during a calendar year.
    (2) The charges may not exceed the provider's customary charges.
    (3) The provider may not charge for any whole blood or packed red 
cells in any of the circumstances specified in Sec. 409.87(c)(2) of 
this chapter.
    (b) Offset for excessive charges. If the charge exceeds the cost to 
the provider, that excess will be deducted from any Medicare payments 
due the provider.

[56 FR 23022, May 20, 1991, as amended at 57 FR 36018, Aug. 12, 1992]



Sec. 489.32  Allowable charges: Noncovered and partially covered services.

    (a) Services requested by beneficiary. If services furnished at the 
request of a beneficiary (or his or her representative) are more 
expensive than, or in excess of, services covered under Medicare--
    (1) A provider may charge the beneficiary an amount that does not 
exceed the difference between--
    (i) The provider's customary charges for the services furnished; and
    (ii) The provider's customary charges for the kinds and amounts of 
services that are covered under Medicare.
    (2) A provider may not charge for the services unless they have been 
requested by the beneficiary (or his or her representative) nor require 
a beneficiary to request services as a condition of admission.
    (3) To avoid misunderstanding and disputes, a provider must inform 
any beneficiary who requests a service for which a charge will be made 
that there will be a specified charge for that service.
    (b) Services not requested by the beneficiary. For special 
provisions that

[[Page 614]]

apply when a provider customarily furnishes more expensive services, see 
Sec. 413.35 of this chapter.

[45 FR 22937, Apr. 4, 1980, as amended at 51 FR 34833, Sept. 30, 1986]



Sec. 489.34  Allowable charges: Hospitals participating in State 
reimbursement control systems or demonstration projects.

    A hospital receiving payment for a covered hospital stay under 
either a State reimbursement control system approved under 1886(c) of 
the Act or a demonstration project authorized under section 402(a) of 
Pub. L. 90-248 (42 U.S.C. 1395b-1) or section 222(a) of Pub. L. 92-603 
(42 U.S.C. 1395b-1 (note)) and that would otherwise be subject to the 
prospective payment system set forth in part 412 of this chapter may 
charge a beneficiary for noncovered services as follows:
    (a) For the custodial care and medically unnecessary services 
described in Sec. 412.42(c) of this chapter, after the conditions of 
Sec. 412.42(c)(1) through (c)(4) are met; and
    (b) For all other services in accordance with the applicable rules 
of this subpart C.

[54 FR 41747, Oct. 11, 1989]



Sec. 489.35  Notice to intermediary.

    The provider must inform its intermediary of any amounts collected 
from a beneficiary or from other persons on his or her behalf.



               Subpart D_Handling of Incorrect Collections



Sec. 489.40  Definition of incorrect collection.

    (a) As used in this subpart, ``incorrect collections'' means any 
amounts collected from a beneficiary (or someone on his or her behalf) 
that are not authorized under subpart C of this part.
    (b) A payment properly made to a provider by an individual not 
considered entitled to Medicare benefits will be deemed to be an 
``incorrect collection'' when the individual is found to be 
retroactively entitled to benefits.



Sec. 489.41  Timing and methods of handling.

    (a) Refund. Prompt refund to the beneficiary or other person is the 
preferred method of handling incorrect collections.
    (b) Setting aside. If the provider cannot refund within 60 days from 
the date on the notice of incorrect collection, it must set aside an 
amount, equal to the amount incorrectly collected, in a separate account 
identified as to the individual to whom the payment is due. This amount 
incorrectly collected must be carried on the provider's records in this 
manner until final disposition is made in accordance with the applicable 
State law.
    (c) Notice to, and action by, intermediary. (1) The provider must 
notify the intermediary of the refund or setting aside required under 
paragraphs (a) and (b) of this section.
    (2) If the provider fails to refund or set aside the required 
amounts, they may be offset against amounts otherwise due the provider.



Sec. 489.42  Payment of offset amounts to beneficiary or other person.

    (a) In order to carry out the commitment to refund amounts 
incorrectly collected, CMS may determine that amounts offset in 
accordance with Sec. 489.41 are to be paid directly to the beneficiary 
or other person from whom the provider received the incorrect 
collection, if:
    (1) CMS finds that the provider has failed, following written 
request, to refund the amount of the incorrect collection to the 
beneficiary or other person; and
    (2) The provider agreement has been terminated in accordance with 
the provisions of subpart E of this part.
    (b) Before making a determination to make payment under paragraph 
(a) of this section, CMS will give written notice to the provider (1) 
explaining that an incorrect collection was made and the amount; (2) 
requesting the provider to refund the incorrect collection to the 
beneficiary or other person; and (3) advising of CMS's intention to make 
a determination under paragraph (a) of this section.

[[Page 615]]

    (c) The notice will afford an authorized official of the provider an 
opportunity to submit, within 20 days from the date on the notice, 
written statement or evidence with respect to the incorrect collection 
and/or offset amounts. CMS will consider any written statement or 
evidence in making a determination.
    (d) Payment to a beneficiary or other person under the provisions of 
paragraph (a) of this section:
    (1) Will not exceed the amount of the incorrect collection; and
    (2) May be considered as payment made to the provider.



 Subpart E_Termination of Agreement and Reinstatement After Termination



Sec. 489.52  Termination by the provider.

    (a) Notice to CMS. (1) A provider that wishes to terminate its 
agreement, except for a SNF as specified in paragraph (a)(2) of this 
section, must send CMS written notice of its intention in accordance 
with paragraph (a)(3) of this section.
    (2) A SNF that wishes to terminate its agreement due to closure of 
the facility must send CMS written notice of its intention at least 60 
days prior to the date of closure, as required at Sec. 483.70(l) of 
this chapter.
    (3) The notice may state the intended date of termination which must 
be the first day of the month.
    (b) Termination date. (1) If the notice does not specify a date, or 
the date is not acceptable to CMS, CMS may set a date that will not be 
more than 6 months from the date on the provider's notice of intent.
    (2) CMS may accept a termination date that is less than 6 months 
after the date on the provider's notice if it determines that to do so 
would not unduly disrupt services to the community or otherwise 
interfere with the effective and efficient administration of the 
Medicare program.
    (3) A cessation of business is deemed to be a termination by the 
provider, effective with the date on which it stopped providing services 
to the community.
    (c) Public notice. (1) The provider must give notice to the public 
at least 15 days before the effective date of termination.
    (2) The notice must--
    (i) Specify the termination date; and
    (ii) Explain to what extent services may continue after that date, 
in accordance with the exceptions set forth in Sec. 489.55.

[45 FR 22937, Apr. 4, 1980, as amended at 76 FR 9512, Feb. 18, 2011; 81 
FR 68872, Oct. 4, 2016; 82 FR 38516, Aug. 14, 2017]



Sec. 489.53  Termination by CMS.

    (a) Basis for termination of agreement. CMS may terminate the 
agreement with any provider if CMS finds that any of the following 
failings is attributable to that provider, and may, in addition to the 
applicable requirements in this chapter governing the termination of 
agreements with suppliers, terminate the agreement with any supplier to 
which the failings in paragraphs (a)(2), (13) and (18) of this section 
are attributable:
    (1) It is not complying with the provisions of title XVIII and the 
applicable regulations of this chapter or with the provisions of the 
agreement.
    (2) The provider or supplier places restrictions on the persons it 
will accept for treatment and it fails either to exempt Medicare 
beneficiaries from those restrictions or to apply them to Medicare 
beneficiaries the same as to all other persons seeking care.
    (3) It no longer meets the appropriate conditions of participation 
or requirements (for SNFs and NFs) set forth elsewhere in this chapter. 
In the case of an RNHCI, it no longer meets the conditions for coverage, 
conditions of participation and requirements set forth elsewhere in this 
chapter. In the case of an OTP, it no longer meets the requirements set 
forth in this section and elsewhere in this chapter.
    (4) It fails to furnish information that CMS finds necessary for a 
determination as to whether payments are or were due under Medicare and 
the amounts due.
    (5) It refuses to permit examination of its fiscal or other records 
by, or on behalf of CMS, as necessary for verification of information 
furnished as a basis for payment under Medicare.

[[Page 616]]

    (6) It failed to furnish information on business transactions as 
required in Sec. 420.205 of this chapter.
    (7) It failed at the time the agreement was entered into or renewed 
to disclose information on convicted individuals as required in Sec. 
420.204 of this chapter.
    (8) It failed to furnish ownership information as required in Sec. 
420.206 of this chapter.
    (9) It failed to comply with civil rights requirements set forth in 
45 CFR parts 80, 84, and 90.
    (10) In the case of a hospital or a critical access hospital as 
defined in section 1861(mm)(1) of the Act that has reason to believe it 
may have received an individual transferred by another hospital in 
violation of Sec. 489.24(d), the hospital failed to report the incident 
to CMS or the State survey agency.
    (11) In the case of a hospital requested to furnish inpatient 
services to CHAMPUS or CHAMPVA beneficiaries or to veterans, it failed 
to comply with Sec. 489.25 or Sec. 489.26, respectively.
    (12) It failed to furnish the notice of discharge rights as required 
by Sec. 489.27.
    (13) The provider or supplier refuses to permit copying of any 
records or other information by, or on behalf of, CMS, as necessary to 
determine or verify compliance with participation requirements.
    (14) The hospital knowingly and willfully fails to accept, on a 
repeated basis, an amount that approximates the Medicare rate 
established under the inpatient hospital prospective payment system, 
minus any enrollee deductibles or copayments, as payment in full from a 
fee-for-service FEHB plan for inpatient hospital services provided to a 
retired Federal enrollee of a fee-for-service FEHB plan, age 65 or 
older, who does not have Medicare Part A benefits.
    (15) It had its enrollment in the Medicare program revoked in 
accordance to Sec. 424.535 of this chapter.
    (16) It has failed to pay a revisit user fee when and if assessed.
    (17) In the case of an HHA, it failed to correct any deficiencies 
within the required time frame.
    (18) The provider or supplier fails to grant immediate access upon a 
reasonable request to a state survey agency or other authorized entity 
for the purpose of determining, in accordance with Sec. 488.3, whether 
the provider or supplier meets the applicable requirements, conditions 
of participation, conditions for coverage, or conditions for 
certification.
    (b) Termination of agreements with certain hospitals. In the case of 
a hospital or critical access hospital that has an emergency department, 
as defined in Sec. 489.24(b), CMS may terminate the provider agreement 
if--
    (1) The hospital fails to comply with the requirements of Sec. 
489.24 (a) through (e), which require the hospital to examine, treat, or 
transfer emergency medical condition cases appropriately, and require 
that hospitals with specialized capabilities or facilities accept an 
appropriate transfer; or
    (2) The hospital fails to comply with Sec. 489.20(m), (q), and (r), 
which require the hospital to report suspected violations of Sec. 
489.24(e), to post conspicuously in emergency departments or in a place 
or places likely to be noticed by all individuals entering the emergency 
departments, as well as those individuals waiting for examination and 
treatment in areas other than traditional emergency departments, (that 
is, entrance, admitting area, waiting room, treatment area), signs 
specifying rights of individuals under this subpart, to post 
conspicuously information indicating whether or not the hospital 
participates in the Medicaid program, and to maintain medical and other 
records related to transferred individuals for a period of 5 years, a 
list of on-call physicians for individuals with emergency medical 
conditions, and a central log on each individual who comes to the 
emergency department seeking assistance.
    (c) Termination of agreements with hospitals that fail to make 
required disclosures. In the case of a physician-owned hospital, as 
defined at Sec. 489.3, CMS may terminate the provider agreement if the 
hospital failed to comply with the requirements of Sec. 489.20(u) or 
(w). In the case of other participating hospitals, as defined at Sec. 
489.24, CMS may terminate the provider agreement if the participating 
hospital failed to comply with the requirements of Sec. 489.20(w).

[[Page 617]]

    (d) Notice of termination--(1) Timing: basic rule. Except as 
provided in paragraphs (d)(2) and (d)(3) of this section, CMS gives the 
provider notice of termination at least 15 days before the effective 
date of termination of the provider agreement.
    (2) Timing exceptions: Immediate jeopardy situations--(i) Hospitals. 
If CMS finds that a hospital is in violation of Sec. 489.24(a) through 
(f), and CMS determines that the violation poses immediate jeopardy to 
the health or safety of individuals who present themselves to the 
hospital for emergency services, CMS--
    (A) Gives the hospital a preliminary notice indicating that its 
provider agreement will be terminated in 23 days if it does not correct 
the identified deficiencies or refute the finding; and
    (B) Gives a final notice of termination, and concurrent notice to 
the public, at least 2 , but not more than 4, days before the effective 
date of termination of the provider agreement.
    (ii) Skilled nursing facilities (SNFs). For an SNF with deficiencies 
that pose immediate jeopardy to the health or safety of residents, CMS 
gives notice at least 2 days before the effective date of termination of 
the provider agreement.
    (iii) Home health agencies (HHAs). For an HHA with deficiencies that 
pose immediate jeopardy to the health and safety of patients, CMS gives 
notice to the HHA at least 2 days before the effective date of 
termination of the provider agreement.
    (3) Notice of LTC facility closure. In the case of a facility where 
CMS terminates a facility's participation under Medicare or Medicaid in 
the absence of immediate jeopardy, CMS determines the appropriate date 
for notification.
    (4) Content of notice. The notice states the reasons for, and the 
effective date of, the termination, and explains the extent to which 
services may continue after that date, in accordance with Sec. 489.55.
    (5) Notice to public. CMS concurrently gives notice of the 
termination to the public.
    (e) Appeal by the provider. A provider may appeal the termination of 
its provider agreement by CMS in accordance with part 498 of this 
chapter.

[51 FR 24492, July 3, 1986]

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



Sec. 489.54  Termination by the OIG.

    (a) Basis for termination. (1) The OIG may terminate the agreement 
of any provider if the OIG finds that any of the following failings can 
be attributed to that provider.
    (i) It has knowingly and willfully made, or caused to be made, any 
false statement or representation of a material fact for use in an 
application or request for payment under Medicare.
    (ii) It has submitted, or caused to be submitted, requests for 
Medicare payment of amounts that substantially exceed the costs it 
incurred in furnishing the services for which payment is requested.
    (iii) It has furnished services that the OIG has determined to be 
substantially in excess of the needs of individuals or of a quality that 
fails to meet professionally recognized standards of health care. The 
OIG will not terminate a provider agreement under paragraph (a) if CMS 
has waived a disallowance with respect to the services in question on 
the grounds that the provider and the beneficiary could not reasonably 
be expected to know that payment would not be made. (The rules for 
determining such lack of knowledge are set forth in Sec. Sec. 405.330 
through 405.334 of this chapter.)
    (b) Notice of termination. The OIG will give the provider notice of 
termination at least 15 days before the effective date of termination of 
the agreement, and will concurrently give notice of termination to the 
public.
    (c) Appeal by the provider. A provider may appeal a termination of 
its agreement by the OIG in accordance with subpart O of part 405 of 
this chapter.
    (d) Other applicable rules. The termination of a provider agreement 
by the OIG is subject to the additional procedures specified in 
Sec. Sec. 1001.105 through

[[Page 618]]

1001.109 of this title for notice and appeals.

[51 FR 24492, July 3, 1986, as amended at 51 FR 34788, Sept. 30, 1986]



Sec. 489.55  Exceptions to effective date of termination.

    (a) Payment is available for up to 30 days after the effective date 
of termination for:
    (1) Inpatient hospital services (including inpatient psychiatric 
hospital services) and post hospital extended care services (except as 
specified in paragraph (b) of this section with respect to LTC 
facilities) furnished to a beneficiary who was admitted before the 
effective date of termination; and
    (2) Home health services and hospice care furnished under a plan 
established before the effective date of termination.
    (b) The Secretary may, as the Secretary determines is appropriate, 
continue to make payments with respect to residents of a long-term care 
facility that has submitted a notification of closure as required at 
Sec. 483.70(l) of this chapter during the period beginning on the date 
such notification is submitted and ending on the date on which the 
residents are successfully relocated.

[76 FR 9512, Feb. 18, 2011, as amended at 78 FR 16805, Mar. 19, 2013; 81 
FR 68872, Oct. 4, 2016]



Sec. 489.57  Reinstatement after termination.

    When a provider agreement has been terminated by CMS under Sec. 
489.53, or by the OIG under Sec. 489.54, a new agreement with that 
provider will not be accepted unless CMS or the OIG, as appropriate, 
finds--
    (a) That the reason for termination of the previous agreement has 
been removed and there is reasonable assurance that it will not recur; 
and
    (b) That the provider has fulfilled, or has made satisfactory 
arrangements to fulfill, all of the statutory and regulatory 
responsibilities of its previous agreement.

[51 FR 24493, July 3, 1986]



               Subpart F_Surety Bond Requirements for HHAs

    Source: 63 FR 313, Jan. 5, 1998, unless otherwise noted.



Sec. 489.60  Definitions.

    As used in this subpart unless the context indicates otherwise--
    Assessment means a sum certain that CMS may assess against an HHA in 
lieu of damages under Titles XI, XVIII, or XXI of the Social Security 
Act or under regulations in this chapter.
    Assets includes but is not limited to any listing that identifies 
Medicare beneficiaries to whom home health services were furnished by a 
participating or formerly participating HHA.
    Civil money penalty means a sum certain that CMS has the authority 
to impose on an HHA as a penalty under Titles XI, XVIII, or XXI of the 
Social Security Act or under regulations in this chapter.
    Participating home health agency means a ``home health agency'' 
(HHA), as that term is defined by section 1861(o) of the Social Security 
Act, that also meets the definition of a ``provider'' set forth at Sec. 
400.202 of this chapter.
    Rider means a notice issued by a Surety that a change in the bond 
has occurred or will occur.
    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.
    Unpaid civil money penalty or assessment means a civil money penalty 
or assessment imposed by CMS on an HHA under Titles XI, XVIII, or XXI of 
the Social Security Act, plus accrued interest, that, after the HHA or 
Surety has exhausted all administrative appeals, remains unpaid (because 
the civil money penalty or assessment has not been paid to, or offset or 
compromised by, CMS) and is not the subject of a written arrangement, 
acceptable to CMS, for payment by the HHA. In the event a written 
arrangement for payment, acceptable to CMS, is made,

[[Page 619]]

an unpaid civil money penalty or assessment also means such civil money 
penalty or assessment, plus accrued interest, that remains due 60 days 
after the HHA's default on such arrangement.
    Unpaid claim means a Medicare overpayment for which the HHA is 
responsible, plus accrued interest, that, 90 days after the date of the 
agency's notice to the HHA of the overpayment, remains due (because the 
overpayment has not been paid to, or recouped or compromised by, CMS) 
and is not the subject of a written arrangement, acceptable to CMS, for 
payment by the HHA. In the event a written arrangement for payment, 
acceptable to CMS, is made, an unpaid claim also means a Medicare 
overpayment for which the HHA is responsible, plus accrued interest, 
that remains due 60 days after the HHA's default on such arrangement.

[63 FR 313, Jan. 5, 1998, as amended at 63 FR 29655, June 1, 1998]



Sec. 489.61  Basic requirement for surety bonds.

    Except as provided in Sec. 489.62, each HHA that is a Medicare 
participating HHA, or that seeks to become a Medicare participating HHA, 
must obtain a surety bond (and furnish to CMS a copy of such surety 
bond) that meets the requirements of this subpart F and CMS's 
instructions.



Sec. 489.62  Requirement waived for Government-operated HHAs.

    An HHA operated by a Federal, State, local, or tribal government 
agency is deemed to have provided CMS with a comparable surety bond 
under State law, and CMS therefore waives the requirements of this 
subpart with respect to such an HHA if, during the preceding 5 years the 
HHA has--
    (a) Not had any unpaid claims or unpaid civil money penalties or 
assessments; and
    (b) Not had any of its claims referred by CMS to the Department of 
Justice or the General Accounting Office in accordance with part 401 of 
this chapter.

[63 FR 313, Jan. 5, 1998, as amended at 63 FR 29655, June 1, 1998]



Sec. 489.63  Parties to the bond.

    The surety bond must name the HHA as Principal, CMS as Obligee, and 
the surety company (and its heirs, executors, administrators, successors 
and assignees, jointly and severally) as Surety.



Sec. 489.64  Authorized Surety and exclusion of surety companies.

    (a) An HHA may obtain a surety bond required under Sec. 489.61 only 
from an authorized Surety.
    (b) An authorized Surety is a surety company that--
    (1) 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; and
    (2) Has not been determined by CMS to be an unauthorized Surety for 
the purpose of an HHA obtaining a surety bond under this section.
    (c) CMS determines that a surety company is an unauthorized Surety 
under this section--
    (1) If, upon request by CMS, the surety company fails to furnish 
timely confirmation of the issuance of, and the validity and accuracy of 
information appearing on, a surety bond an HHA presents to CMS that 
shows the surety company as Surety on the bond;
    (2) If, upon presentation by CMS 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 CMS in full the amount requested, up to the face amount of 
the bond; or
    (3) For other good cause.
    (d) Any determination CMS makes under paragraph (c) of this section 
is effective immediately when notice of the determination is published 
in the Federal Register and remains in effect until a notice of 
reinstatement is published in the Federal Register.
    (e) Any determination CMS makes under paragraph (c) of this section 
does not affect the Surety's liability under any surety bond issued by a 
surety company to an HHA before notice of

[[Page 620]]

such determination is published in accordance with paragraph (d) of this 
section.
    (f) A determination by CMS that a surety company is an unauthorized 
Surety under this section is not a debarment, suspension, or exclusion 
for the purposes of Executive Order No. 12549 (3 CFR, 1986 comp., p. 
189).



Sec. 489.65  Amount of the bond.

    (a) Basic rule. The amount of the surety bond must be $50,000 or 15 
percent of the Medicare payments made by CMS to the HHA in the HHA's 
most recent fiscal year for which a cost report has been accepted by 
CMS, whichever is greater.
    (b) Computation of the 15 percent: Participating HHA. The 15 percent 
is computed as follows:
    (1) For the initial bond--on the basis of Medicare payments made by 
CMS to the HHA in the HHA's most recent fiscal year as shown in the 
HHA's most recent cost report that has been accepted by CMS. If the 
initial bond will cover less than a full fiscal year, the computation of 
the 15 percent will be based on the number of months of the fiscal year 
that the bond will cover.
    (2) For subsequent bonds--on the basis of Medicare payments made by 
CMS in the most recent fiscal year for which a cost report has been 
accepted. However, if payments in the first six months of the current 
fiscal year differ from such an amount by more than 25 percent, then the 
amount of the bond is 15 percent of such payments projected on an 
annualized basis.
    (c) 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 Medicare payments made by CMS to 
the participating or formerly participating HHA in the most recent 
fiscal year that a cost report has been accepted.
    (d) Change of ownership. For an HHA that undergoes a change of 
ownership the 15 percent is computed on the basis of Medicare payments 
made by CMS to the HHA for the most recently accepted cost report.
    (e) 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.
    (f) Exception to the basic rule. If an HHA's overpayment in the most 
recently accepted cost report exceeds 15 percent of annual payments, CMS 
may require the HHA to secure a bond in an amount up to or equal to the 
amount of overpayment, provided the amount of the bond is not less than 
$50,000.
    (g) 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 subpart 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 CMS specifies in accordance with paragraph (f) of this 
section, whichever amount is greater.

[63 FR 313, Jan. 5, 1998, as amended at 63 FR 29655, June 1, 1998]



Sec. 489.66  Additional requirements of the surety bond.

    The surety bond that an HHA obtains under this subpart must meet the 
following additional requirements:
    (a) The bond must guarantee that within 30 days of receiving written 
notice from CMS of an unpaid claim or unpaid civil money penalty or 
assessment, which notice contains sufficient evidence to establish the 
Surety's liability under the bond, the Surety will pay CMS, up to the 
stated amount of the bond--
    (1) The full amount of any unpaid claim, plus accrued interest, for 
which the HHA is responsible; and
    (2) The full amount of any unpaid civil money penalty or assessment 
imposed by CMS on the HHA, plus accrued interest.
    (b) The bond must provide the following:
    (1) The Surety is liable for unpaid claims, unpaid civil money 
penalties,

[[Page 621]]

and unpaid assessments that are discovered when the surety bond is in 
effect, regardless of when the payment, overpayment, or other event 
giving rise to the claim, civil money penalty, or assessment occurred, 
provided CMS makes a written demand for payment from the Surety during, 
or within 90 days after, the term of the bond.
    (2) If the HHA fails to furnish a bond meeting the requirements of 
this subpart F for the year following expiration of the term of an 
annual bond, or if the HHA fails to submit a rider when a rider is 
required to be submitted under this subpart, or if the HHA's provider 
agreement is terminated, the last bond or rider, as applicable, 
submitted by the HHA to CMS, which bond or applicable rider meets the 
requirements of this subpart, remains effective and the Surety remains 
liable for unpaid claims, civil money penalties, and assessments that--
    (i) CMS determines or imposes on or asserts against the HHA based on 
overpayments or other events that took place during or prior to the term 
of the last bond or rider; and
    (ii) Were determined or imposed during the 2 years following the 
date the HHA failed to submit a bond or required rider or the date the 
HHA's provider agreement is terminated, whichever is later.
    (c) The bond must provide that the Surety's liability to CMS under 
the bond is not extinguished by any action of the HHA, the Surety, or 
CMS, including but not necessarily limited to any of the following 
actions:
    (1) 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--
    (i) The Surety furnishes CMS 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
    (ii) The HHA furnishes CMS with a new bond that meets the 
requirements of this subpart.
    (2) The Surety's failure to continue to meet the requirements of 
Sec. 489.64(a) or CMS's determination that the surety company is an 
unauthorized Surety under Sec. 489.64(b).
    (3) Termination of the HHA's provider agreement.
    (4) Any action by CMS to suspend, offset, or otherwise recover 
payments to the HHA.
    (5) Any action by the HHA to--
    (i) Cease operation;
    (ii) Sell or transfer any asset or ownership interest;
    (iii) File for bankruptcy; or
    (iv) Fail to pay the Surety.
    (6) 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 Medicare payments upon which 
the amount of the surety bond is determined will not cause the Surety's 
liability to CMS to exceed the amount of the bond.
    (7) The HHA's failure to exercise available appeal rights under 
Medicare or to assign such rights to the Surety.
    (d) The bond must provide that actions under the bond may be brought 
by CMS or by CMS's fiscal intermediaries.
    (e) The bond must provide the Surety's name, street address or post 
office box number, city, state, and zipcode to which the CMS notice 
provided for in paragraph (a) of this section is to be sent.

[63 FR 313, Jan. 5, 1998, as amended at 63 FR 29655, June 1, 1998]



Sec. 489.67  Term and type of bond.

    (a) Each participating HHA that does not meet the criteria for 
waiver under Sec. 489.62 must submit to CMS in a form as CMS may 
specify, a surety bond for a term beginning January 1, 1998. If an 
annual bond is submitted for the initial term, it must be effective 
through the end of the HHA's current fiscal year.
    (b) Type of bond. The type of bond required to be submitted by an 
HHA under this subpart may be either--
    (1) An annual bond (that is, a bond that specifies an effective 
annual period corresponding to the HHA's fiscal year); or

[[Page 622]]

    (2) 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, via the issuance of a rider, for a particular 
fiscal year for which the bond amount has changed or will change.
    (c) HHA that seeks to become a participating HHA. (1) An HHA that 
seeks to become a participating HHA must submit a surety bond with its 
enrollment application (Form CMS-855, OMB number 0938-0685). The term of 
the initial surety bond must be effective from the effective date of 
provider agreement as specified in Sec. 489.13 of this part. However, 
if the effective date of the provider agreement is less than 30 days 
before the end of the HHA's current fiscal year, the HHA may obtain a 
bond effective through the end of the next fiscal year, provided the 
amount of the bond is the greater of $75,000 or 20 percent of the amount 
determined from the computation specified in Sec. 489.65(c) as 
applicable.
    (2) 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.
    (d) Change of ownership. An HHA that undergoes a change of ownership 
must submit the surety bond to CMS not later than the effective date of 
the change of ownership and the bond must be effective from the 
effective date of the change of ownership through the remainder of the 
HHA's fiscal year.
    (e) Government-operated HHA that loses its waiver. A government-
operated HHA that, as of January 1, 1998, meets the criteria for waiver 
under Sec. 489.62 but thereafter is determined by CMS to not meet such 
criteria, must submit a surety bond to CMS within 60 days after it 
receives notice from CMS that it no longer meets the criteria for 
waiver.
    (f) 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 CMS within 30 days of 
obtaining the bond from the new Surety.

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

[63 FR 315, Jan. 5, 1998, as amended at 63 FR 10731, Mar. 4, 1998; 63 FR 
29656, June 1, 1998; 63 FR 41171, July 31, 1998]



Sec. 489.68  Effect of failure to obtain, maintain, and timely file 
a surety bond.

    (a) The failure of a participating HHA to obtain, file timely, and 
maintain a surety bond in accordance with this subpart F and CMS's 
instructions is sufficient under Sec. 489.53(a)(1) for CMS to terminate 
the HHA's provider agreement.
    (b) The failure of an HHA seeking to become a participating HHA to 
obtain and file timely a surety bond in accordance with this Subpart F 
and CMS's instructions is sufficient under Sec. 489.12(a)(3) for CMS to 
refuse to enter into a provider agreement with the HHA.



Sec. 489.69  Evidence of compliance.

    (a) CMS may at any time require an HHA to make a specific showing of 
being in compliance with the requirements of this Subpart F and may 
require the HHA to submit such additional evidence as CMS considers 
sufficient to demonstrate the HHA's compliance.
    (b) If requested by CMS to do so, the failure of an HHA to timely 
furnish sufficient evidence to CMS to demonstrate compliance with the 
requirements of this Subpart F is sufficient for CMS to terminate the 
HHA's provider agreement under Sec. 489.53(a)(1) or to refuse to enter 
into a provider agreement with the HHA under Sec. 489.12(a)(3), as 
applicable.



Sec. 489.70  Effect of payment by the Surety.

    A Surety's payment to CMS under a bond for an unpaid claim or an 
unpaid civil money penalty or assessment, constitutes--
    (a) Collection of the unpaid claim or unpaid civil money penalty or 
assessment (to the extent the Surety's payment on the bond covers such 
unpaid claim, civil money penalty, or assessment); and

[[Page 623]]

    (b) A basis for termination of the HHA's provider agreement under 
Sec. 489.53(a)(1).



Sec. 489.71  Surety's standing to appeal Medicare determinations.

    A Surety has standing to appeal any matter that the HHA could 
appeal, provided the Surety satisfies all jurisdictional and procedural 
requirements that would otherwise have applied to the HHA, and provided 
the HHA is not, itself, actively pursuing its appeal rights under this 
chapter, and provided further that, with respect to unpaid claims, the 
Surety has paid CMS all amounts owed to CMS by the HHA on such unpaid 
claims, up to the amount of the bond.

[63 FR 29656, June 1, 1998]



Sec. 489.72  Effect of review reversing determination.

    In the event a Surety has paid CMS on the basis of liability 
incurred under a bond obtained by an HHA under this subpart F, and to 
the extent the HHA that obtained such bond (or the Surety under Sec. 
489.71) is subsequently successful in appealing the determination that 
was the basis of the unpaid claim or unpaid civil money penalty or 
assessment that caused the Surety to pay CMS under the bond, CMS will 
refund to the Surety the amount the Surety paid to CMS to the extent 
such amount relates to the matter that was successfully appealed by the 
HHA (or by the Surety), provided all review, including judicial review, 
has been completed on such matter. Any additional amounts owing as a 
result of the appeal will be paid to the HHA.



Sec. 489.73  Effect of conditions of payment.

    If a Surety has paid an amount to CMS on the basis of liability 
incurred under a bond obtained by an HHA under this subpart F, and CMS 
subsequently collects from the HHA, in whole or in part, on such unpaid 
claim, civil money penalty, or assessment that was the basis for the 
Surety's liability, CMS reimburses the Surety such amount as CMS 
collected from the HHA, up to the amount paid by the Surety to CMS, 
provided the Surety has no other liability to CMS under the bond.

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

[63 FR 29656, June 1, 1998]



Sec. 489.74  Incorporation into existing provider agreements.

    The requirements of this subpart F are deemed to be incorporated 
into existing HHA provider agreements effective January 1, 1998.

[63 FR 315, Jan. 5, 1998. Redesignated at 63 FR 29656, June 1, 1998]

Subparts G-H [Reserved]



                      Subpart I_Advance Directives

    Source: 57 FR 8203, Mar. 6, 1992, unless otherwise noted.



Sec. 489.100  Definition.

    For purposes of this part, advance directive means a written 
instruction, such as a living will or durable power of attorney for 
health care, recognized under State law (whether statutory or as 
recognized by the courts of the State), relating to the provision of 
health care when the individual is incapacitated.



Sec. 489.102  Requirements for providers.

    (a) Hospitals, critical access hospitals, skilled nursing 
facilities, nursing facilities, home health agencies, providers of home 
health care (and for Medicaid purposes, providers of personal care 
services), hospices, and religious nonmedical health care institutions 
must maintain written policies and procedures concerning advance 
directives with respect to all adult individuals receiving medical care, 
or patient care in the case of a patient in a religious nonmedical 
health care institution, by or through the provider and are required to:
    (1) Provide written information to such individuals concerning--
    (i) An individual's rights under State law (whether statutory or 
recognized by the courts of the State) to make decisions concerning such 
medical care, including the right to accept or refuse medical or 
surgical treatment and the

[[Page 624]]

right to formulate, at the individual's option, advance directives. 
Providers are permitted to contract with other entities to furnish this 
information but are still legally responsible for ensuring that the 
requirements of this section are met. Providers are to update and 
disseminate amended information as soon as possible, but no later than 
90 days from the effective date of the changes to State law; and
    (ii) The written policies of the provider or organization respecting 
the implementation of such rights, including a clear and precise 
statement of limitation if the provider cannot implement an advance 
directive on the basis of conscience. At a minimum, a provider's 
statement of limitation should:
    (A) Clarify any differences between institution-wide conscience 
objections and those that may be raised by individual physicians;
    (B) Identify the state legal authority permitting such objection; 
and
    (C) Describe the range of medical conditions or procedures affected 
by the conscience objection.
    (2) Document in a prominent part of the individual's current medical 
record, or patient care record in the case of an individual in a 
religious nonmedical health care institution, whether or not the 
individual has executed an advance directive;
    (3) Not condition the provision of care or otherwise discriminate 
against an individual based on whether or not the individual has 
executed an advance directive;
    (4) Ensure compliance with requirements of State law (whether 
statutory or recognized by the courts of the State) regarding advance 
directives. The provider must inform individuals that complaints 
concerning the advance directive requirements may be filed with the 
State survey and certification agency;
    (5) Provide for education of staff concerning its policies and 
procedures on advance directives; and
    (6) Provide for community education regarding issues concerning 
advance directives that may include material required in paragraph 
(a)(1) of this section, either directly or in concert with other 
providers and organizations. Separate community education materials may 
be developed and used, at the discretion of providers. The same written 
materials do not have to be provided in all settings, but the material 
should define what constitutes an advance directive, emphasizing that an 
advance directive is designed to enhance an incapacitated individual's 
control over medical treatment, and describe applicable State law 
concerning advance directives. A provider must be able to document its 
community education efforts.
    (b) The information specified in paragraph (a) of this section is 
furnished:
    (1) In the case of a hospital, at the time of the individual's 
admission as an inpatient.
    (2) In the case of a skilled nursing facility at the time of the 
individual's admission as a resident.
    (3)(i) In the case of a home health agency, in advance of the 
individual coming under the care of the agency. The HHA may furnish 
advance directives information to a patient at the time of the first 
home visit, as long as the information is furnished before care is 
provided.
    (ii) In the case of personal care services, in advance of the 
individual coming under the care of the personal care services provider. 
The personal care provider may furnish advance directives information to 
a patient at the time of the first home visit, as long as the 
information is furnished before care is provided.
    (4) In the case of a hospice program, at the time of initial receipt 
of hospice care by the individual from the program.
    (c) The providers listed in paragraph (a) of this section--
    (1) Are not required to provide care that conflicts with an advance 
directive.
    (2) Are not required to implement an advance directive if, as a 
matter of conscience, the provider cannot implement an advance directive 
and State law allows any health care provider or any agent of such 
provider to conscientiously object.
    (d) Prepaid or eligible organizations (as specified in sections 
1833(a)(1)(A) and 1876(b) of the Act) must meet the

[[Page 625]]

requirements specified in Sec. 417.436 of this chapter.
    (e) If an adult individual is incapacitated at the time of admission 
or at the start of care and is unable to receive information (due to the 
incapacitating conditions or a mental disorder) or articulate whether or 
not he or she has executed an advance directive, then the provider may 
give advance directive information to the individual's family or 
surrogate in the same manner that it issues other materials about 
policies and procedures to the family of the incapacitated individual or 
to a surrogate or other concerned persons in accordance with State law. 
The provider is not relieved of its obligation to provide this 
information to the individual once he or she is no longer incapacitated 
or unable to receive such information. Follow-up procedures must be in 
place to provide the information to the individual directly at the 
appropriate time.

[57 FR 8203, Mar. 6, 1992, as amended at 59 FR 45403, Sept. 1, 1994; 60 
FR 33294, June 27, 1995; 62 FR 46037, Aug. 29, 1997; 64 FR 67052, Nov. 
30, 1999; 68 FR 66720, Nov. 28, 2003]



Sec. 489.104  Effective dates.

    These provisions apply to services furnished on or after December 1, 
1991 payments made under section 1833(a)(1)(A) of the Act on or after 
December 1, 1991, and contracts effective on or after December 1, 1991.



PART 491_CERTIFICATION OF CERTAIN HEALTH FACILITIES--
Table of Contents



Subpart A_Rural Health Clinics: Conditions for Certification; and FQHCs 
                         Conditions for Coverage

Sec.
491.1 Purpose and scope.
491.2 Definitions.
491.3 Certification procedures.
491.4 Compliance with Federal, State and local laws.
491.5 Location of clinic.
491.6 Physical plant and environment.
491.7 Organizational structure.
491.8 Staffing and staff responsibilities.
491.9 Provision of services.
491.10 Patient health records.
491.11 Program evaluation.
491.12 Emergency preparedness.

    Authority: 42 U.S.C. 263a and 1302.



Subpart A_Rural Health Clinics: Conditions for Certification; and FQHCs 
                         Conditions for Coverage



Sec. 491.1  Purpose and scope.

    This subpart sets forth the conditions that rural health clinics or 
FQHCs must meet in order to qualify for reimbursement under Medicare 
(title XVIII of the Social Security Act) and that rural health clinics 
must meet in order to qualify for reimbursement under Medicaid (title 
XIX of the Act).

[57 FR 24982, June 12, 1992]



Sec. 491.2  Definitions.

    As used in this subpart, unless the context indicates otherwise:
    Direct services means services provided by the clinic's staff.
    FQHC means an entity as defined in Sec. 405.2401(b).
    Nurse practitioner means a registered professional nurse who is 
currently licensed to practice in the State, who meets the State's 
requirements governing the qualifications of nurse practitioners, and 
who meets one of the following conditions:
    (1) Is currently certified as a primary care nurse practitioner by 
the American Nurses' Association or by the National Board of Pediatric 
Nurse Practitioners and Associates; or
    (2) Has satisfactorily completed a formal 1 academic year 
educational program that:
    (i) Prepares registered nurses to perform an expanded role in the 
delivery of primary care;
    (ii) Includes at least 4 months (in the aggregate) of classroom 
instruction and a component of supervised clinical practice; and
    (iii) Awards a degree, diploma, or certificate to persons who 
successfully complete the program; or
    (3) Has successfully completed a formal educational program (for 
preparing registered nurses to perform an expanded role in the delivery 
of primary care) that does not meet the requirements of paragraph (2) of 
this definition, and has been performing an expanded role in the 
delivery of primary care for a total of 12 months during the

[[Page 626]]

18-month period immediately preceding the effective date of this 
subpart.
    Physician means the following:
    (1) As it pertains to the supervision, collaboration, and oversight 
requirements in sections 1861(aa)(2)(B) and (aa)(3) of the Act, a doctor 
of medicine or osteopathy legally authorized to practice medicine or 
surgery in the State in which the function is performed; and
    (2) Within limitations as to the specific services furnished, a 
doctor of dental surgery or of dental medicine, a doctor of optometry, a 
doctor of podiatry or surgical chiropody or a chiropractor (see section 
1861(r) of the Act for specific limitations).
    Physician assistant means a person who meets the applicable State 
requirements governing the qualifications for assistants to primary care 
physicians, and who meets at least one of the following conditions:
    (1) Is currently certified by the National Commission on 
Certification of Physician Assistants to assist primary care physicians; 
or
    (2) Has satisfactorily completed a program for preparing physician's 
assistants that:
    (i) Was at least 1 academic year in length;
    (ii) Consisted of supervised clinical practice and at least 4 months 
(in the aggregate) of classroom instruction directed toward preparing 
students to deliver health care; and
    (iii) Was accredited by the American Medical Association's Committee 
on Allied Health Education and Accreditation; or
    (3) Has satisfactorily completed a formal educational program (for 
preparing physician assistants) that does not meet the requirements of 
paragraph (2) of this definition and assisted primary care physicians 
for a total of 12 months during the 18-month period that ended on 
December 31, 1986.
    Rural area means an area that is not delineated as an urbanized area 
by the Bureau of the Census.
    Rural health clinic or clinic means a clinic that is located in a 
rural area designated as a shortage area, is not a rehabilitation agency 
or a facility primarily for the care and treatment of mental diseases, 
and meets all other requirements of this subpart.
    Shortage area means a defined geographic area designated by the 
Department as having either a shortage of personal health services 
(under section 1302(7) of the Public Health Service Act) or a shortage 
of primary medical care manpower (under section 332 of that Act).
    Secretary means the Secretary of Health and Human Services, or any 
official to whom he has delegated the pertinent authority.

[71 FR 55345, Sept. 22, 2006, as amended at 79 FR 27156, May 12, 2014]



Sec. 491.3  Certification procedures.

    A rural health clinic will be certified for participation in 
Medicare in accordance with subpart S of 42 CFR part 405. The Secretary 
will notify the State Medicaid agency whenever he has certified or 
denied certification under Medicare for a prospective rural health 
clinic in that State. A clinic certified under Medicare will be deemed 
to meet the standards for certification under Medicaid.

[71 FR 55346, Sept. 22, 2006]



Sec. 491.4  Compliance with Federal, State and local laws.

    The rural health clinic or FQHC and its staff are in compliance with 
applicable Federal, State and local laws and regulations.
    (a) Licensure of clinic or center. The clinic or center is licensed 
pursuant to applicable State and local law.
    (b) Licensure, certification or registration of personnel. Staff of 
the clinic or center are licensed, certified or registered in accordance 
with applicable State and local laws.

[57 FR 24982, June 12, 1992]



Sec. 491.5  Location of clinic.

    (a) Basic requirements. (1) An RHC is located in a rural area that 
is designated as a shortage area.
    (2) An FQHC is located in a rural or urban area that is designated 
as either a shortage area or an area that has a medically underserved 
population.
    (3) Both the RHC and the FQHC may be permanent or mobile units.

[[Page 627]]

    (i) Permanent unit. The objects, equipment, and supplies necessary 
for the provision of the services furnished directly by the clinic or 
center are housed in a permanent structure.
    (ii) Mobile unit. The objects, equipment, and supplies necessary for 
the provision of the services furnished directly by the clinic or center 
are housed in a mobile structure, which has fixed, scheduled 
location(s).
    (iii) Permanent unit in more than one location. If clinic or center 
services are furnished at permanent units in more than one location, 
each unit is independently considered for approval as a rural health 
clinic or for approval as an FQHC.
    (b) Exceptions. (1) CMS does not disqualify an RHC approved under 
this subpart if the area in which it is located subsequently fails to 
meet the definition of a rural, shortage area.
    (2) A private, nonprofit facility that meets all other conditions of 
this subpart except for location in a shortage area will be certified 
if, on July 1, 1977, it was operating in a rural area that is determined 
by the Secretary (on the basis of the ratio of primary care physicians 
to the general population) to have an insufficient supply of physicians 
to meet the needs of the area served.
    (3) Determinations on these exceptions will be made by the Secretary 
upon application by the facility.
    (c) Criteria for designation of rural areas. (1) Rural areas are 
areas not delineated as urbanized areas in the last census conducted by 
the Census Bureau.
    (2) Excluded from the rural area classification are:
    (i) Central cities of 50,000 inhabitants or more;
    (ii) Cities with at least 25,000 inhabitants which, together with 
contiguous areas having stipulated population density, have combined 
populations of 50,000 and constitute, for general economic and social 
purposes, single communities;
    (iii) Closely settled territories surrounding cities and 
specifically designated by the Census Bureau as urban.
    (3) Included in the rural area classification are those portions of 
extended cities that the Census Bureau has determined to be rural.
    (d) Criteria for designation of shortage areas. (1) The criteria for 
determination of shortage of personal health services (under section 
1302(7) of the Public Health Services Act), are:
    (i) The ratio of primary care physicians practicing within the area 
to the resident population;
    (ii) The infant mortality rate;
    (iii) The percent of the population 65 years of age or older; and
    (iv) The percent of the population with a family income below the 
poverty level.
    (2) The criteria for determination of shortage of primary medical 
care manpower (under section 332(a)(1)(A) of the Public Health Services 
Act) are:
    (i) The area served is a rational area for the delivery of primary 
medical care services;
    (ii) The ratio of primary care physicians practicing within the area 
to the resident population; and
    (iii) The primary medical care manpower in contiguous areas is 
overutilized, excessively distant, or inaccessible to the population in 
this area.
    (e) Medically underserved population. A medically underserved 
population includes the following:
    (1) A population of an urban or rural area that is designated by PHS 
as having a shortage of personal health services.
    (2) A population group that is designated by PHS as having a 
shortage of personal health services.
    (f) Requirements specific to FQHCs. An FQHC approved for 
participation in Medicare must meet one of the following criteria:
    (1) Furnish services to a medically underserved population.
    (2) Be located in a medically underserved area, as demonstrated by 
an application approved by PHS.

    Cross Reference: See 42 CFR 110.203(g) (41 FR 45718, Oct. 15, 1976) 
and 42 CFR Part 5 (42 FR 1586, Jan. 10, 1978).

[43 FR 5375, Feb. 8, 1978. Redesignated at 50 FR 33034, Aug. 16, 1985, 
and amended at 57 FR 24982, June 12, 1992; 61 FR 14658, Apr. 3, 1996; 68 
FR 74816, Dec. 24, 2003; 71 FR 55346, Sept. 22, 2006]

[[Page 628]]



Sec. 491.6  Physical plant and environment.

    (a) Construction. The clinic or center is constructed, arranged, and 
maintained to insure access to and safety of patients, and provides 
adequate space for the provision of direct services.
    (b) Maintenance. The clinic or center has a preventive maintenance 
program to ensure that:
    (1) All essential mechanical, electrical and patient-care equipment 
is maintained in safe operating condition;
    (2) Drugs and biologicals are appropriately stored; and
    (3) The premises are clean and orderly.

[57 FR 24983, June 12, 1992, as amended at 81 FR 64041, Sept. 16, 2016]



Sec. 491.7  Organizational structure.

    (a) Basic requirements. (1) The clinic or center is under the 
medical direction of a physician, and has a health care staff that meets 
the requirements of Sec. 491.8.
    (2) The organization's policies and its lines of authority and 
responsibilities are clearly set forth in writing.
    (b) Disclosure. The clinic or center discloses the names and 
addresses of:
    (1) Its owners, in accordance with section 1124 of the Social 
Security Act (42 U.S.C. 132 A-3);
    (2) The person principally responsible for directing the operation 
of the clinic or center; and
    (3) The person responsible for medical direction.

[57 FR 24983, June 12, 1992]



Sec. 491.8  Staffing and staff responsibilities.

    (a) Staffing. (1) The clinic or center has a health care staff that 
includes one or more physicians. Rural health clinic staffs must also 
include one or more physician's assistants or nurse practitioners.
    (2) The physician member of the staff may be the owner of the rural 
health clinic, an employee of the clinic or center, or under agreement 
with the clinic or center to carry out the responsibilities required 
under this section.
    (3) The physician assistant, nurse practitioner, nurse-midwife, 
clinical social worker or clinical psychologist member of the staff may 
be the owner or an employee of the clinic or center, or may furnish 
services under contract to the clinic or center. In the case of a 
clinic, at least one physician assistant or nurse practitioner must be 
an employee of the clinic.
    (4) The staff may also include ancillary personnel who are 
supervised by the professional staff.
    (5) The staff is sufficient to provide the services essential to the 
operation of the clinic or center.
    (6) A physician, nurse practitioner, physician assistant, certified 
nurse-midwife, clinical social worker, or clinical psychologist is 
available to furnish patient care services at all times the clinic or 
center operates. In addition, for RHCs, a nurse practitioner, physician 
assistant, or certified nurse-midwife is available to furnish patient 
care services at least 50 percent of the time the RHC operates.
    (b) Physician responsibilities. The physician performs the 
following:
    (1) Except for services furnished by a clinical psychologist in an 
FQHC, which State law permits to be provided without physician 
supervision, provides medical direction for the clinic's or center's 
health care activities and consultation for, and medical supervision of, 
the health care staff.
    (2) In conjunction with the physician assistant and/or nurse 
practitioner member(s), participates in developing, executing, and 
periodically reviewing the clinic's or center's written policies and the 
services provided to Federal program patients.
    (3) Periodically reviews the clinic's or center's patient records, 
provides medical orders, and provides medical care services to the 
patients of the clinic or center.
    (c) Physician assistant and nurse practitioner responsibilities. (1) 
The physician assistant and the nurse practitioner members of the 
clinic's or center's staff:
    (i) Participate in the development, execution and periodic review of 
the written policies governing the services the clinic or center 
furnishes;
    (ii) Participate with a physician in a periodic review of the 
patients' health records.

[[Page 629]]

    (2) The physician assistant or nurse practitioner performs the 
following functions, to the extent they are not being performed by a 
physician:
    (i) Provides services in accordance with the clinic's or center's 
policies;
    (ii) Arranges for, or refers patients to, needed services that 
cannot be provided at the clinic or center; and
    (iii) Assures that adequate patient health records are maintained 
and transferred as required when patients are referred.

[57 FR 24983, June 12, 1992, as amended at 61 FR 14658, Apr. 3, 1996; 68 
FR 74817, Dec. 24, 2003; 71 FR 55346, Sept. 22, 2006; 79 FR 25480, May 
2, 2014; 79 FR 27156, May 12, 2014]



Sec. 491.9  Provision of services.

    (a) Basic requirements. (1) All services offered by the clinic or 
center are furnished in accordance with applicable Federal, State, and 
local laws; and
    (2) The clinic or center is primarily engaged in providing 
outpatient health services and meets all other conditions of this 
subpart.
    (3) The laboratory requirements in paragraph (c)(2) of this section 
apply to RHCs, but do not apply to FQHCs.
    (b) Patient care policies. (1) The clinic's or center's health care 
services are furnished in accordance with appropriate written policies 
which are consistent with applicable State law.
    (2) The policies are developed with the advice of a group of 
professional personnel that includes one or more physicians and one or 
more physician assistants or nurse practitioners. At least one member is 
not a member of the clinic or center staff.
    (3) The policies include:
    (i) A description of the services the clinic or center furnishes 
directly and those furnished through agreement or arrangement.
    (ii) Guidelines for the medical management of health problems which 
include the conditions requiring medical consultation and/or patient 
referral, the maintenance of health care records, and procedures for the 
periodic review and evaluation of the services furnished by the clinic 
or center.
    (iii) Rules for the storage, handling, and administration of drugs 
and biologicals.
    (4) These policies are reviewed at least biennially by the group of 
professional personnel required under paragraph (b)(2) of this section 
and reviewed as necessary by the RHC or FQHC.
    (c) Direct services--(1) General. The clinic or center staff 
furnishes those diagnostic and therapeutic services and supplies that 
are commonly furnished in a physician's office or at the entry point 
into the health care delivery system. These include medical history, 
physical examination, assessment of health status, and treatment for a 
variety of medical conditions.
    (2) Laboratory. These requirements apply to RHCs but not to FQHCs. 
The RHC provides laboratory services in accordance with part 493 of this 
chapter, which implements the provisions of section 353 of the Public 
Health Service Act. The RHC provides basic laboratory services essential 
to the immediate diagnosis and treatment of the patient, including:
    (i) Chemical examinations of urine by stick or tablet method or both 
(including urine ketones);
    (ii) Hemoglobin or hematocrit;
    (iii) Blood glucose;
    (iv) Examination of stool specimens for occult blood;
    (v) Pregnancy tests; and
    (vi) Primary culturing for transmittal to a certified laboratory.
    (3) Emergency. The clinic or center provides medical emergency 
procedures as a first response to common life-threatening injuries and 
acute illness and has available the drugs and biologicals commonly used 
in life saving procedures, such as analgesics, anesthetics (local), 
antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.
    (d) Services provided through agreements or arrangements. (1) The 
clinic or center has agreements or arrangements with one or more 
providers or suppliers participating under Medicare or Medicaid to 
furnish other services to its patients, including:
    (i) Inpatient hospital care;
    (ii) Physician(s) services (whether furnished in the hospital, the 
office, the patient's home, a skilled nursing facility, or elsewhere); 
and

[[Page 630]]

    (iii) Additional and specialized diagnostic and laboratory services 
that are not available at the clinic or center.
    (2) If the agreements are not in writing, there is evidence that 
patients referred by the clinic or center are being accepted and 
treated.

[57 FR 24983, June 12, 1992, as amended at 58 FR 63536, Dec. 2, 1993; 84 
FR 51832, Sept. 30, 2019]



Sec. 491.10  Patient health records.

    (a) Records system. (1) The clinic or center maintains a clinical 
record system in accordance with written policies and procedures.
    (2) A designated member of the professional staff is responsible for 
maintaining the records and for insuring that they are completely and 
accurately documented, readily accessible, and systematically organized.
    (3) For each patient receiving health care services, the clinic or 
center maintains a record that includes, as applicable:
    (i) Identification and social data, evidence of consent forms, 
pertinent medical history, assessment of the health status and health 
care needs of the patient, and a brief summary of the episode, 
disposition, and instructions to the patient;
    (ii) Reports of physical examinations, diagnostic and laboratory 
test results, and consultative findings;
    (iii) All physician's orders, reports of treatments and medications, 
and other pertinent information necessary to monitor the patient's 
progress;
    (iv) Signatures of the physician or other health care professional.
    (b) Protection of record information. (1) The clinic or center 
maintains the confidentiality of record information and provides 
safeguards against loss, destruction or unauthorized use.
    (2) Written policies and procedures govern the use and removal of 
records from the clinic or center and the conditions for release of 
information.
    (3) The patient's written consent is required for release of 
information not authorized to be released without such consent.
    (c) Retention of records. The records are retained for at least 6 
years from date of last entry, and longer if required by State statute.

(Secs. 1102, 1833 and 1902(a)(13), Social Security Act; 49 Stat. 647, 91 
Stat. 1485 (42 U.S.C. 1302, 13951 and 1396a(a)(13)))

[43 FR 30529, July 14, 1978. Redesignated at 50 FR 33034, Aug. 16, 1985, 
as amended at 57 FR 24984, June 12, 1992]



Sec. 491.11  Program evaluation.

    (a) The clinic or center carries out, or arranges for, a biennial 
evaluation of its total program.
    (b) The evaluation includes review of:
    (1) The utilization of clinic or center services, including at least 
the number of patients served and the volume of services;
    (2) A representative sample of both active and closed clinical 
records; and
    (3) The clinic's or center's health care policies.
    (c) The purpose of the evaluation is to determine whether:
    (1) The utilization of services was appropriate;
    (2) The established policies were followed; and
    (3) Any changes are needed.
    (d) The clinic or center staff considers the findings of the 
evaluation and takes corrective action if necessary.

[71 FR 55346, Sept. 22, 2006, as amended at 84 FR 51832, Sept. 30, 2019]



Sec. 491.12  Emergency preparedness.

    The Rural Health Clinic/Federally Qualified Health Center (RHC/FQHC) 
must comply with all applicable Federal, State, and local emergency 
preparedness requirements. The RHC/FQHC 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 RHC or FQHC must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
every 2 years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.

[[Page 631]]

    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the RHC/FQHC 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 RHC or FQHC 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) Safe evacuation from the RHC/FQHC, which includes appropriate 
placement of exit signs; staff responsibilities and needs of the 
patients.
    (2) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (3) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (4) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State and Federally designated health care professionals to address 
surge needs during an emergency.
    (c) Communication plan. The RHC or FQHC 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) Patients' physicians.
    (iv) Other RHCs/FQHCs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) RHC/FQHC's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (5) A means of providing information about the RHC/FQHC's needs, and 
its ability to provide assistance, to the authority having jurisdiction 
or the Incident Command Center, or designee.
    (d) Training and testing. The RHC or FQHC 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 RHC/FQHC must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles,
    (ii) Provide emergency preparedness training at least every 2 years.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the RHC/FQHC must conduct training on the updated 
policies and procedures.

[[Page 632]]

    (2) Testing. The RHC or FQHC must conduct exercises to test the 
emergency plan at least annually. The RHC or FQHC must do the following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, an 
individual, facility-based functional exercise every 2 years; or.
    (B) If the RHC or FQHC experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the RHC or 
FQHC 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 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 RHC or FQHC's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the RHC or FQHC's emergency plan, as needed.
    (e) Integrated healthcare systems. If a RHC/FQHC 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 RHC/FQHC may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of 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 
all of 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 64041, Sept. 16, 2016, as amended by 84 FR 51832, Sept. 30, 2019]



PART 493_LABORATORY REQUIREMENTS--Table of Contents



                      Subpart A_General Provisions

Sec.
493.1 Basis and scope.
493.2 Definitions.
493.3 Applicability.
493.5 Categories of tests by complexity.
493.15 Laboratories performing waived tests.
493.17 Test categorization.
493.19 Provider-performed microscopy (PPM) procedures.
493.20 Laboratories performing tests of moderate complexity.
493.25 Laboratories performing tests of high complexity.

[[Page 633]]

                     Subpart B_Certificate of Waiver

493.35 Application for a certificate of waiver.
493.37 Requirements for a certificate of waiver.
493.39 Notification requirements for laboratories issued a certificate 
          of waiver.
493.41 Condition: Reporting of SARS-CoV-2 test results.

 Subpart C_Registration Certificate, Certificate for Provider-performed 
          Microscopy Procedures, and Certificate of Compliance

493.43 Application for registration certificate, certificate for 
          provider-performed microscopy (PPM) procedures, and 
          certificate of compliance.
493.45 Requirements for a registration certificate.
493.47 Requirements for a certificate for provider-performed microscopy 
          (PPM) procedures.
493.49 Requirements for a certificate of compliance.
493.51 Notification requirements for laboratories issued a certificate 
          of compliance.
493.53 Notification requirements for laboratories issued a certificate 
          for provider-performed microscopy (PPM) procedures.

                 Subpart D_Certificate of Accreditation

493.55 Application for registration certificate and certificate of 
          accreditation.
493.57 Requirements for a registration certificate.
493.61 Requirements for a certificate of accreditation.
493.63 Notification requirements for laboratories issued a certificate 
          of accreditation.

     Subpart E_Accreditation by a Private, Nonprofit Accreditation 
  Organization or Exemption Under an Approved State Laboratory Program

493.551 General requirements for laboratories.
493.553 Approval process (application and reapplication) for 
          accreditation organizations and State licensure programs.
493.555 Federal review of laboratory requirements.
493.557 Additional submission requirements.
493.559 Publication of approval of deeming authority or CLIA exemption.
493.561 Denial of application or reapplication.
493.563 Validation inspections--Basis and focus.
493.565 Selection for validation inspection--laboratory 
          responsibilities.
493.567 Refusal to cooperate with validation inspection.
493.569 Consequences of a finding of noncompliance as a result of a 
          validation inspection.
493.571 Disclosure of accreditation, State and CMS validation inspection 
          results.
493.573 Continuing Federal oversight of private nonprofit accreditation 
          organizations and approved State licensure programs.
493.575 Removal of deeming authority or CLIA exemption and final 
          determination review.

                    Subpart F_General Administration

493.602 Scope of subpart.
493.606 Applicability of subpart.
493.638 Certificate fees.
493.639 Fee for revised certificate.
493.643 Fee for determination of program compliance.
493.645 Additional fee(s) applicable to approved State laboratory 
          programs and laboratories issued a certificate of 
          accreditation, certificate of waiver, or certificate for PPM 
          procedures.
493.646 Payment of fees.
493.649 Methodology for determining fee amount.

Subpart G [Reserved]

    Subpart H_Participation in Proficiency Testing for Laboratories 
                      Performing Nonwaived Testing

493.801 Condition: Enrollment and testing of samples.
493.803 Condition: Successful participation.
493.807 Condition: Reinstatement of laboratories performing nonwaived 
          testing.

   Proficiency Testing by Specialty and Subspecialty for Laboratories 
  Performing Tests of Moderate Complexity (Including the Subcategory), 
           High Complexity, or Any Combination of These Tests

493.821 Condition: Microbiology.
493.823 Standard; Bacteriology.
493.825 Standard; Mycobacteriology.
493.827 Standard; Mycology.
493.829 Standard; Parasitology.
493.831 Standard; Virology.
493.833 Condition: Diagnostic immunology.
493.835 Standard; Syphilis serology.
493.837 Standard; General immunology.
493.839 Condition: Chemistry.
493.841 Standard; Routine chemistry.
493.843 Standard; Endocrinology.
493.845 Standard; Toxicology.
493.849 Condition: Hematology.
493.851 Standard; Hematology.
493.853 Condition: Pathology.
493.855 Standard; Cytology: gynecologic examinations.

[[Page 634]]

493.857 Condition: Immunohematology.
493.859 Standard; ABO group and D (Rho) typing.
493.861 Standard; Unexpected antibody detection.
493.863 Standard; Compatibility testing.
493.865 Standard; Antibody identification.

      Subpart I_Proficiency Testing Programs for Nonwaived Testing

493.901 Approval of proficiency testing programs.
493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing programs.

       Proficiency Testing Programs by Specialty and Subspecialty

493.909 Microbiology.
493.911 Bacteriology.
493.913 Mycobacteriology.
493.915 Mycology.
493.917 Parasitology.
493.919 Virology.
493.921 Diagnostic immunology.
493.923 Syphilis serology.
493.927 General immunology.
493.929 Chemistry.
493.931 Routine chemistry.
493.933 Endocrinology.
493.937 Toxicology.
493.941 Hematology (including routine hematology and coagulation).
493.945 Cytology; gynecologic examinations.
493.959 Immunohematology.

         Subpart J_Facility Administration for Nonwaived Testing

493.1100 Condition: Facility administration.
493.1101 Standard: Facilities.
493.1103 Standard: Requirements for transfusion services.
493.1105 Standard: Retention requirements.

             Subpart K_Quality System for Nonwaived Testing

493.1200 Introduction.
493.1201 Condition: Bacteriology.
493.1202 Condition: Mycobacteriology.
493.1203 Condition: Mycology.
493.1204 Condition: Parasitology.
493.1205 Condition: Virology.
493.1207 Condition: Syphilis serology.
493.1208 Condition: General immunology.
493.1210 Condition: Routine chemistry.
493.1211 Condition: Urinalysis.
493.1212 Condition: Endocrinology.
493.1213 Condition: Toxicology.
493.1215 Condition: Hematology.
493.1217 Condition: Immunohematology.
493.1219 Condition: Histopathology.
493.1220 Condition: Oral pathology.
493.1221 Condition: Cytology.
493.1225 Condition: Clinical cytogenetics.
493.1226 Condition: Radiobioassay.
493.1227 Condition: Histocompatibility.

                       General Laboratory Systems

493.1230 Condition: General laboratory systems.
493.1231 Standard: Confidentiality of patient information.
493.1232 Standard: Specimen identification and integrity.
493.1233 Standard: Complaint investigations.
493.1234 Standard: Communications.
493.1235 Standard: Personnel competency assessment policies.
493.1236 Standard: Evaluation of proficiency testing performance.
493.1239 Standard: General laboratory systems quality assessment.

                           Preanalytic Systems

493.1240 Condition: Preanalytic systems.
493.1241 Standard: Test request.
493.1242 Standard: Specimen submission, handling, and referral.
493.1249 Standard: Preanalytic systems quality assessment.

                            Analytic Systems

493.1250 Condition: Analytic systems.
493.1251 Standard: Procedure manual.
493.1252 Standard: Test systems, equipment, instruments, reagents, 
          materials, and supplies.
493.1253 Standard: Establishment and verification of performance 
          specifications.
493.1254 Standard: Maintenance and function checks.
493.1255 Standard: Calibration and calibration verification procedures.
493.1256 Standard: Control procedures.
493.1261 Standard: Bacteriology.
493.1262 Standard: Mycobacteriology.
493.1263 Standard: Mycology.
493.1264 Standard: Parasitology.
493.1265 Standard: Virology.
493.1267 Standard: Routine chemistry.
493.1269 Standard: Hematology.
493.1271 Standard: Immunohematology.
493.1273 Standard: Histopathology.
493.1274 Standard: Cytology.
493.1276 Standard: Clinical cytogenetics.
493.1278 Standard: Histocompatibility.
493.1281 Standard: Comparison of test results.
493.1282 Standard: Corrective actions.
493.1283 Standard: Test records.
493.1289 Standard: Analytic systems quality assessment.

                          Postanalytic Systems

493.1290 Condition: Postanalytic systems.
493.1291 Standard: Test report.
493.1299 Standard: Postanalytic systems quality assessment.

[[Page 635]]

Subpart L [Reserved]

                Subpart M_Personnel for Nonwaived Testing

493.1351 General.

 Laboratories Performing Provider-Performed Microscopy (PPM) Procedures

493.1353 Scope.
493.1355 Condition: Laboratories performing PPM procedures; laboratory 
          director.
493.1357 Standard; laboratory director qualifications.
493.1359 Standard; PPM laboratory director responsibilities.
493.1361 Condition: Laboratories performing PPM procedures; testing 
          personnel.
493.1363 Standard; PPM testing personnel qualifications.
493.1365 Standard; PPM testing personnel responsibilities.

           Laboratories Performing Moderate Complexity Testing

493.1403 Condition: Laboratories performing moderate complexity testing; 
          laboratory director.
493.1405 Standard; Laboratory director qualifications.
493.1406 Standard; Laboratory director qualifications on or before 
          February 28, 1992.
493.1407 Standard; Laboratory director responsibilities.
493.1409 Condition: Laboratories performing moderate complexity testing; 
          technical consultant.
493.1411 Standard; Technical consultant qualifications.
493.1413 Standard; Technical consultant responsibilities.
493.1415 Condition: Laboratories performing moderate complexity testing; 
          clinical consultant.
493.1417 Standard; Clinical consultant qualifications.
493.1419 Standard; Clinical consultant responsibilities.
493.1421 Condition: Laboratories performing moderate complexity testing; 
          testing personnel.
493.1423 Standard; Testing personnel qualifications.
493.1425 Standard; Testing personnel responsibilities.

             Laboratories Performing High Complexity Testing

493.1441 Condition: Laboratories performing high complexity testing; 
          laboratory director.
493.1443 Standard; Laboratory director qualifications.
493.1445 Standard; Laboratory director responsibilities.
493.1447 Condition: Laboratories performing high complexity testing; 
          technical supervisor.
493.1449 Standard; Technical supervisor qualifications.
493.1451 Standard; Technical supervisor responsibilities.
493.1453 Condition: Laboratories performing high complexity testing; 
          clinical consultant.
493.1455 Standard; Clinical consultant qualifications.
493.1457 Standard; Clinical consultant responsibilities.
493.1459 Condition: Laboratories performing high complexity testing; 
          general supervisor.
493.1461 Standard; General supervisor qualifications.
493.1462 General supervisor qualifications on or before February 28, 
          1992.
493.1463 Standard; General supervisor responsibilities.
493.1467 Condition: Laboratories performing high complexity testing; 
          cytology general supervisor.
493.1469 Standard; Cytology general supervisor qualifications.
493.1471 Standard; Cytology general supervisor responsibilities.
493.1481 Condition: Laboratories performing high complexity testing; 
          cytotechnologist.
493.1483 Standard; Cytotechnologist qualifications.
493.1485 Standard; Cytotechnologist responsibilities.
493.1487 Condition: Laboratories performing high complexity testing; 
          testing personnel.
493.1489 Standard; Testing personnel qualifications.
493.1491 Technologist qualifications on or before February 28, 1992.
493.1495 Standard; Testing personnel responsibilities.

Subparts N-P [Reserved]

                          Subpart Q_Inspection

493.1771 Condition: Inspection requirements applicable to all CLIA-
          certified and CLIA-exempt laboratories.
493.1773 Standard: Basic inspection requirements for all laboratories 
          issued a CLIA certificate and CLIA-exempt laboratories.
493.1775 Standard: Inspection of laboratories issued a certificate of 
          waiver or a certificate for provider-performed microscopy 
          procedures.
493.1777 Standard: Inspection of laboratories that have requested or 
          have been issued a certificate of compliance.

[[Page 636]]

493.1780 Standard: Inspection of CLIA-exempt laboratories or 
          laboratories requesting or issued a certificate of 
          accreditation.

                    Subpart R_Enforcement Procedures

493.1800 Basis and scope.
493.1804 General considerations.
493.1806 Available sanctions: All laboratories.
493.1807 Additional sanctions: Laboratories that participate in 
          Medicare.
493.1808 Adverse action on any type of CLIA certificate: Effect on 
          Medicare approval.
493.1809 Limitation on Medicaid payment.
493.1810 Imposition and lifting of alternative sanctions.
493.1812 Action when deficiencies pose immediate jeopardy.
493.1814 Action when deficiencies are at the condition level but do not 
          pose immediate jeopardy.
493.1816 Action when deficiencies are not at the condition level.
493.1820 Ensuring timely correction of deficiencies.
493.1826 Suspension of part of Medicare payments.
493.1828 Suspension of all Medicare payments.
493.1832 Directed plan of correction and directed portion of a plan of 
          correction.
493.1834 Civil money penalty.
493.1836 State onsite monitoring.
493.1838 Training and technical assistance for unsuccessful 
          participation in proficiency testing.
493.1840 Suspension, limitation, or revocation of any type of CLIA 
          certificate.
493.1842 Cancellation of Medicare approval.
493.1844 Appeals procedures.
493.1846 Civil action.
493.1850 Laboratory registry.

Subpart S [Reserved]

                         Subpart T_Consultations

493.2001 Establishment and function of the Clinical Laboratory 
          Improvement Advisory Committee.

    Authority: 42 U.S.C. 263a, 1302, 1395x(e), the sentence following 
1395x(s)(11) through 1395x(s)(16)).

    Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.



                      Subpart A_General Provisions

    Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.



Sec. 493.1  Basis and scope.

    This part sets forth the conditions that all laboratories must meet 
to be certified to perform testing on human specimens under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA). It implements sections 
1861(e) and (j), the sentence following section 1861(s)(13), and 
1902(a)(9) of the Social Security Act, and section 353 of the Public 
Health Service Act, as amended by section 2 of the Taking Essential 
Steps for Testing Act of 2012. This part applies to all laboratories as 
defined under ``laboratory'' in Sec. 493.2 of this part. This part also 
applies to laboratories seeking payment under the Medicare and Medicaid 
programs. The requirements are the same for Medicare approval as for 
CLIA certification.

[57 FR 7139, Feb. 28, 1992, as amended at 79 FR 25480, May 2, 2014]



Sec. 493.2  Definitions.

    As used in this part, unless the context indicates otherwise--
    Accredited institution means a school or program which--
    (a) Admits as regular student only persons having a certificate of 
graduation from a school providing secondary education, or the 
recognized equivalent of such certificate;
    (b) Is legally authorized within the State to provide a program of 
education beyond secondary education;
    (c) Provides an educational program for which it awards a bachelor's 
degree or provides not less than a 2-year program which is acceptable 
toward such a degree, or provides an educational program for which it 
awards a master's or doctoral degree;
    (d) Is accredited by a nationally recognized accrediting agency or 
association.
    This definition includes any foreign institution of higher education 
that HHS or its designee determines meets substantially equivalent 
requirements.
    Accredited laboratory means a laboratory that has voluntarily 
applied for and been accredited by a private, nonprofit accreditation 
organization approved by CMS in accordance with this part;

[[Page 637]]

    Adverse action means the imposition of a principal or alternative 
sanction by CMS.
    ALJ stands for Administrative Law Judge.
    Alternative sanctions means sanctions that may be imposed in lieu of 
or in addition to principal sanctions. The term is synonymous with 
``intermediate sanctions'' as used in section 1846 of the Act.
    Analyte means a substance or constituent for which the laboratory 
conducts testing.
    Approved accreditation organization for laboratories means a 
private, nonprofit accreditation organization that has formally applied 
for and received CMS's approval based on the organization's compliance 
with this part.
    Approved State laboratory program means a licensure or other 
regulatory program for laboratories in a State, the requirements of 
which are imposed under State law, and the State laboratory program has 
received CMS approval based on the State's compliance with this part.
    Authorized person means an individual authorized under State law to 
order tests or receive test results, or both.
    Calibration means a process of testing and adjusting an instrument 
or test system to establish a correlation between the measurement 
response and the concentration or amount of the substance that is being 
measured by the test procedure.
    Calibration verification means the assaying of materials of known 
concentration in the same manner as patient samples to substantiate the 
instrument or test system's calibration throughout the reportable range 
for patient test results.
    Challenge means, for quantitative tests, an assessment of the amount 
of substance or analyte present or measured in a sample. For qualitative 
tests, a challenge means the determination of the presence or the 
absence of an analyte, organism, or substance in a sample.
    CLIA means the Clinical Laboratory Improvement Amendments of 1988.
    CLIA certificate means any of the following types of certificates 
issued by CMS or its agent:
    (1) Certificate of compliance means a certificate issued to a 
laboratory after an inspection that finds the laboratory to be in 
compliance with all applicable condition level requirements, or reissued 
before the expiration date, pending an appeal, in accordance with Sec. 
493.49, when an inspection has found the laboratory to be out of 
compliance with one or more condition level requirements.
    (2) Certificate for provider-performed microscopy (PPM) procedures 
means a certificate issued or reissued before the expiration date, 
pending an appeal, in accordance with Sec. 493.47, to a laboratory in 
which a physician, midlevel practitioner or dentist performs no tests 
other than PPM procedures and, if desired, waived tests listed in Sec. 
493.15(c).
    (3) Certificate of accreditation means a certificate issued on the 
basis of the laboratory's accreditation by an accreditation organization 
approved by CMS (indicating that the laboratory is deemed to meet 
applicable CLIA requirements) or reissued before the expiration date, 
pending an appeal, in accordance with Sec. 493.61, when a validation or 
complaint survey has found the laboratory to be noncompliant with one or 
more CLIA conditions.
    (4) Certificate of registration or registration certificate means a 
certificate issued or reissued before the expiration date, pending an 
appeal, in accordance with Sec. 493.45, that enables the entity to 
conduct moderate or high complexity laboratory testing or both until the 
entity is determined to be in compliance through a survey by CMS or its 
agent; or in accordance with Sec. 493.57 to an entity that is 
accredited by an approved accreditation organization.
    (5) Certificate of waiver means a certificate issued or reissued 
before the expiration date, pending an appeal, in accordance with Sec. 
493.37, to a laboratory to perform only the waived tests listed at Sec. 
493.15(c).
    CLIA-exempt laboratory means a laboratory that has been licensed or 
approved by a State where CMS has determined that the State has enacted 
laws relating to laboratory requirements that are equal to or more 
stringent than CLIA requirements and the

[[Page 638]]

State licensure program has been approved by CMS in accordance with 
subpart E of this part.
    Condition level deficiency means noncompliance with one or more 
condition level requirements.
    Condition level requirements means any of the requirements 
identified as ``conditions'' in Sec. 493.41 and subparts G through Q of 
this part.
    Confirmatory testing means testing performed by a second analytical 
procedure that could be used to substantiate or bring into question the 
result of an initial laboratory test.
    Credible allegation of compliance means a statement or documentation 
that--
    (1) Is made by a representative of a laboratory that has a history 
of having maintained a commitment to compliance and of taking corrective 
action when required;
    (2) Is realistic in terms of its being possible to accomplish the 
required corrective action between the date of the exit conference and 
the date of the allegation; and
    (3) Indicates that the problem has been resolved.
    Dentist means a doctor of dental medicine or doctor of dental 
surgery licensed by the State to practice dentistry within the State in 
which the laboratory is located.
    Distributive testing means laboratory testing performed on the same 
specimen, or an aliquot of it, that requires sharing it between two or 
more laboratories to obtain all data required to complete an 
interpretation or calculation necessary to provide a final reportable 
result for the originally ordered test. When such testing occurs at 
multiple locations with different CLIA certificates, it is considered 
distributive testing.
    Equivalency means that an accreditation organization's or a State 
laboratory program's requirements, taken as a whole, are equal to or 
more stringent than the CLIA requirements established by CMS, taken as 
whole. It is acceptable for an accreditation organization's or State 
laboratory program's requirements to be organized differently or 
otherwise vary from the CLIA requirements, as long as (1) all of the 
requirements taken as a whole would provide at least the same protection 
as the CLIA requirements taken as a whole; and (2) a finding of 
noncompliance with respect to CLIA requirements taken as a whole would 
be matched by a finding of noncompliance with the accreditation or State 
requirements taken as a whole.
    CMS agent means an entity with which CMS arranges to inspect 
laboratories and assess laboratory activities against CLIA requirements 
and may be a State survey agency, a private, nonprofit organization 
other than an approved accreditation organization, a component of HHS, 
or any other governmental component CMS approves for this purpose. In 
those instances where all of the laboratories in a State are exempt from 
CLIA requirements, based on the approval of a State's exemption request, 
the State survey agency is not the CMS agent.
    FDA-cleared or approved test system means a test system cleared or 
approved by the FDA through the premarket notification (510(k)) or 
premarket approval (PMA) process for in-vitro diagnostic use. Unless 
otherwise stated, this includes test systems exempt from FDA premarket 
clearance or approval.
    HHS means the Department of Health and Human Services, or its 
designee.
    Immediate jeopardy means a situation in which immediate corrective 
action is necessary because the laboratory's noncompliance with one or 
more condition level requirements has already caused, is causing, or is 
likely to cause, at any time, serious injury or harm, or death, to 
individuals served by the laboratory or to the health or safety of the 
general public. This term is synonymous with imminent and serious risk 
to human health and significant hazard to the public health.
    Intentional violation means knowing and willful noncompliance with 
any CLIA condition.
    Kit means all components of a test that are packaged together.
    Laboratory means a facility for the biological, microbiological, 
serological, chemical, immunohematological, hematological, biophysical, 
cytological, pathological, or other examination of materials derived 
from

[[Page 639]]

the human body for the purpose of providing information for the 
diagnosis, prevention, or treatment of any disease or impairment of, or 
the assessment of the health of, human beings. These examinations also 
include procedures to determine, measure, or otherwise describe the 
presence or absence of various substances or organisms in the body. 
Facilities only collecting or preparing specimens (or both) or only 
serving as a mailing service and not performing testing are not 
considered laboratories.
    Midlevel practitioner means a nurse midwife, nurse practitioner, or 
physician assistant, licensed by the State within which the individual 
practices, if such licensing is required in the State in which the 
laboratory is located.
    Nonwaived test means any test system, assay, or examination that has 
not been found to meet the statutory criteria specified at section 
353(d)(3) of the Public Health Service Act.
    Operator means the individual or group of individuals who oversee 
all facets of the operation of a laboratory and who bear primary 
responsibility for the safety and reliability of the results of all 
specimen testing performed in that laboratory. The term includes--
    (1) A director of the laboratory if he or she meets the stated 
criteria; and
    (2) The members of the board of directors and the officers of a 
laboratory that is a small corporation under subchapter S of the 
Internal Revenue Code.
    Owner means any person who owns any interest in a laboratory except 
for an interest in a laboratory whose stock and/or securities are 
publicly traded. (That is e.g., the purchase of shares of stock or 
securities on the New York Stock Exchange in a corporation owning a 
laboratory would not make a person an owner for the purpose of this 
regulation.)
    Party means a laboratory affected by any of the enforcement 
procedures set forth in this subpart, by CMS or the OIG, as appropriate.
    Performance characteristic means a property of a test that is used 
to describe its quality, e.g., accuracy, precision, analytical 
sensitivity, analytical specificity, reportable range, reference range, 
etc.
    Performance specification means a value or range of values for a 
performance characteristic, established or verified by the laboratory, 
that is used to describe the quality of patient test results.
    Physician means an individual with a doctor of medicine, doctor of 
osteopathy, or doctor of podiatric medicine degree who is licensed by 
the State to practice medicine, osteopathy, or podiatry within the State 
in which the laboratory is located.
    Principal sanction means the suspension, limitation, or revocation 
of any type of CLIA certificate or the cancellation of the laboratory's 
approval to receive Medicare payment for its services.
    Prospective laboratory means a laboratory that is operating under a 
registration certificate or is seeking any of the three other types of 
CLIA certificates.
    Rate of disparity means the percentage of sample validation 
inspections for a specific accreditation organization or State where 
CMS, the State survey agency or other CMS agent finds noncompliance with 
one or more condition level requirements but no comparable deficiencies 
were cited by the accreditation organization or the State, and it is 
reasonable to conclude that the deficiencies were present at the time of 
the most recent accreditation organization or State licensure 
inspection.

    Example: Assume the State survey agency, CMS or other CMS agent 
performs 200 sample validation inspections for laboratories accredited 
by a single accreditation organization or licensed in an exempt State 
during a validation review period and finds that 60 of the 200 
laboratories had one or more condition level requirements out of 
compliance. CMS reviews the validation and accreditation organization's 
or State's inspections of the validated laboratories and determines that 
the State or accreditation organization found comparable deficiencies in 
22 of the 60 laboratories and it is reasonable to conclude that 
deficiencies were present in the remaining 38 laboratories at the time 
of the accreditation organization's or State's inspection. Thirty-eight 
divided by 200 equals a 19 percent rate of disparity.


[[Page 640]]


    Referee laboratory means a laboratory currently in compliance with 
applicable CLIA requirements, that has had a record of satisfactory 
proficiency testing performance for all testing events for at least one 
year for a specific test, analyte, subspecialty, or specialty and has 
been designated by an HHS approved proficiency testing program as a 
referee laboratory for analyzing proficiency testing specimens for the 
purpose of determining the correct response for the specimens in a 
testing event for that specific test, analyte, subspecialty, or 
specialty.
    Reference range means the range of test values expected for a 
designated population of individuals, e.g., 95 percent of individuals 
that are presumed to be healthy (or normal).
    Reflex testing means confirmatory or additional laboratory testing 
that is automatically requested by a laboratory under its standard 
operating procedures for patient specimens when the laboratory's 
findings indicate test results that are abnormal, are outside a 
predetermined range, or meet other pre-established criteria for 
additional testing.
    Repeat proficiency testing referral means a second instance in which 
a proficiency testing sample, or a portion of a sample, is referred, for 
any reason, to another laboratory for analysis prior to the laboratory's 
proficiency testing program event cut-off date within the period of time 
encompassing the two prior survey cycles (including initial 
certification, recertification, or the equivalent for laboratories 
surveyed by an approved accreditation organization).
    Reportable range means the span of test result values over which the 
laboratory can establish or verify the accuracy of the instrument or 
test system measurement response.
    Sample in proficiency testing means the material contained in a 
vial, on a slide, or other unit that contains material to be tested by 
proficiency testing program participants. When possible, samples are of 
human origin.
    State includes, for purposes of this part, each of the 50 States, 
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin 
Islands and a political subdivision of a State where the State, acting 
pursuant to State law, has expressly delegated powers to the political 
subdivision sufficient to authorize the political subdivision to act for 
the State in enforcing requirements equal to or more stringent than CLIA 
requirements.
    State licensure means the issuance of a license to, or the approval 
of, a laboratory by a State laboratory program as meeting standards for 
licensing or approval established under State law.
    State licensure program means a State laboratory licensure or 
approval program.
    State survey agency means the State health agency or other 
appropriate State or local agency that has an agreement under section 
1864 of the Social Security Act and is used by CMS to perform surveys 
and inspections.
    Substantial allegation of noncompliance means a complaint from any 
of a variety of sources (including complaints submitted in person, by 
telephone, through written correspondence, or in newspaper or magazine 
articles) that, if substantiated, would have an impact on the health and 
safety of the general public or of individuals served by a laboratory 
and raises doubts as to a laboratory's compliance with any condition 
level requirement.
    Target value for quantitative tests means either the mean of all 
participant responses after removal of outliers (those responses greater 
than 3 standard deviations from the original mean) or the mean 
established by definitive or reference methods acceptable for use in the 
National Reference System for the Clinical Laboratory (NRSCL) by the 
National Committee for the Clinical Laboratory Standards (NCCLS). In 
instances where definitive or reference methods are not available or a 
specific method's results demonstrate bias that is not observed with 
actual patient specimens, as determined by a defensible scientific 
protocol, a comparative method or a method group (``peer'' group) may be 
used. If the method group is less than 10 participants, ``target value'' 
means the overall mean after outlier removal (as defined above) unless 
acceptable scientific reasons are available to indicate that such an 
evaluation is not appropriate.

[[Page 641]]

    Test system means the instructions and all of the instrumentation, 
equipment, reagents, and supplies needed to perform an assay or 
examination and generate test results.
    Unsatisfactory proficiency testing performance means failure to 
attain the minimum satisfactory score for an analyte, test, 
subspecialty, or specialty for a testing event.
    Unsuccessful participation in proficiency testing means any of the 
following:
    (1) Unsatisfactory performance for the same analyte in two 
consecutive or two out of three testing events.
    (2) Repeated unsatisfactory overall testing event scores for two 
consecutive or two out of three testing events for the same specialty or 
subspecialty.
    (3) An unsatisfactory testing event score for those subspecialties 
not graded by analyte (that is, bacteriology, mycobacteriology, 
virology, parasitology, mycology, blood compatibility, immunohematology, 
or syphilis serology) for the same subspecialty for two consecutive or 
two out of three testing events.
    (4) Failure of a laboratory performing gynecologic cytology to meet 
the standard at Sec. 493.855.
    Unsuccessful proficiency testing performance means a failure to 
attain the minimum satisfactory score for an analyte, test, 
subspecialty, or specialty for two consecutive or two of three 
consecutive testing events.
    Validation review period means the one year time period during which 
CMS conducts validation inspections and evaluates the results of the 
most recent surveys performed by an accreditation organization or State 
laboratory program.
    Waived test means a test system, assay, or examination that HHS has 
determined meets the CLIA statutory criteria as specified for waiver 
under section 353(d)(3) of the Public Health Service Act.

[57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992; 57 
FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, Jan. 
19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR 20043, Apr. 24, 1995; 63 FR 
26732, May 14, 1998; 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 
2003; 79 FR 25480, May 2, 2014; 79 FR 27157, May 12, 2014; 85 FR 54873, 
Sept. 2, 2020]



Sec. 493.3  Applicability.

    (a) Basic rule. Except as specified in paragraph (b) of this 
section, a laboratory will be cited as out of compliance with section 
353 of the Public Health Service Act unless it--
    (1) Has a current, unrevoked or unsuspended certificate of waiver, 
registration certificate, certificate of compliance, certificate for PPM 
procedures, or certificate of accreditation issued by HHS applicable to 
the category of examinations or procedures performed by the laboratory; 
or
    (2) Is CLIA-exempt.
    (b) Exception. These rules do not apply to components or functions 
of--
    (1) Any facility or component of a facility that only performs 
testing for forensic purposes;
    (2) Research laboratories that test human specimens but do not 
report patient specific results for the diagnosis, prevention or 
treatment of any disease or impairment of, or the assessment of the 
health of individual patients; or
    (3) Laboratories certified by the Substance Abuse and Mental Health 
Services Administration (SAMHSA), in which drug testing is performed 
which meets SAMHSA guidelines and regulations. However, all other 
testing conducted by a SAMHSA-certified laboratory is subject to this 
rule.
    (c) Federal laboratories. Laboratories under the jurisdiction of an 
agency of the Federal Government are subject to the rules of this part, 
except that the Secretary may modify the application of such 
requirements as appropriate.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 60 
FR 20043, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003]



Sec. 493.5  Categories of tests by complexity.

    (a) Laboratory tests are categorized as one of the following:
    (1) Waived tests.
    (2) Tests of moderate complexity, including the subcategory of PPM 
procedures.
    (3) Tests of high complexity.
    (b) A laboratory may perform only waived tests, only tests of 
moderate complexity, only PPM procedures, only tests of high complexity 
or any combination of these tests.

[[Page 642]]

    (c) Each laboratory must be either CLIA-exempt or possess one of the 
following CLIA certificates, as defined in Sec. 493.2:
    (1) Certificate of registration or registration certificate.
    (2) Certificate of waiver.
    (3) Certificate for PPM procedures.
    (4) Certificate of compliance.
    (5) Certificate of accreditation.

[60 FR 20043, Apr. 24, 1995]



Sec. 493.15  Laboratories performing waived tests.

    (a) Requirement. Tests for certificate of waiver must meet the 
descriptive criteria specified in paragraph (b) of this section.
    (b) Criteria. Test systems are simple laboratory examinations and 
procedures which--
    (1) Are cleared by FDA for home use;
    (2) Employ methodologies that are so simple and accurate as to 
render the likelihood of erroneous results negligible; or
    (3) Pose no reasonable risk of harm to the patient if the test is 
performed incorrectly.
    (c) Certificate of waiver tests. A laboratory may qualify for a 
certificate of waiver under section 353 of the PHS Act if it restricts 
the tests that it performs to one or more of the following tests or 
examinations (or additional tests added to this list as provided under 
paragraph (d) of this section) and no others:
    (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the 
following:
    (i) Bilirubin;
    (ii) Glucose;
    (iii) Hemoglobin;
    (iv) Ketone;
    (v) Leukocytes;
    (vi) Nitrite;
    (vii) pH;
    (viii) Protein;
    (ix) Specific gravity; and
    (x) Urobilinogen.
    (2) Fecal occult blood-non-automated;
    (3) Ovulation tests--visual color comparison tests for human 
luteinizing hormone;
    (4) Urine pregnancy tests--visual color comparison tests;
    (5) Erythrocyte sedimentation rate--non-automated;
    (6) Hemoglobin--copper sulfate--non-automated;
    (7) Blood glucose by glucose monitoring devices cleared by the FDA 
specifically for home use;
    (8) Spun microhematocrit; and
    (9) Hemoglobin by single analyte instruments with self-contained or 
component features to perform specimen/reagent interaction, providing 
direct measurement and readout.
    (d) Revisions to criteria for test categorization and the list of 
waived tests. HHS will determine whether a laboratory test meets the 
criteria listed under paragraph (b) of this section for a waived test. 
Revisions to the list of waived tests approved by HHS will be published 
in the Federal Register in a notice with opportunity for comment.
    (e) Laboratories eligible for a certificate of waiver must--
    (1) Follow manufacturers' instructions for performing the test; and
    (2) Meet the requirements in subpart B, Certificate of Waiver, of 
this part.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 82 
FR 48773, Oct. 20, 2017]



Sec. 493.17  Test categorization.

    (a) Categorization by criteria. Notices will be published in the 
Federal Register which list each specific test system, assay, and 
examination categorized by complexity. Using the seven criteria 
specified in this paragraph for categorizing tests of moderate or high 
complexity, each specific laboratory test system, assay, and examination 
will be graded for level of complexity by assigning scores of 1, 2, or 3 
within each criteria. The score of ``1'' indicates the lowest level of 
complexity, and the score of ``3'' indicates the highest level. These 
scores will be totaled. Test systems, assays or examinations receiving 
scores of 12 or less will be categorized as moderate complexity, while 
those receiving scores above 12 will be categorized as high complexity.

    Note: A score of ``2'' will be assigned to a criteria heading when 
the characteristics for a particular test are intermediate between

[[Page 643]]

the descriptions listed for scores of ``1'' and ``3.''

    (1) Knowledge--(i) Score 1. (A) Minimal scientific and technical 
knowledge is required to perform the test; and
    (B) Knowledge required to perform the test may be obtained through 
on-the-job instruction.
    (ii) Score 3. Specialized scientific and technical knowledge is 
essential to perform preanalytic, analytic or postanalytic phases of the 
testing.
    (2) Training and experience--(i) Score 1. (A) Minimal training is 
required for preanalytic, analytic and postanalytic phases of the 
testing process; and
    (B) Limited experience is required to perform the test.
    (ii) Score 3. (A) Specialized training is essential to perform the 
preanalytic, analytic or postanalytic testing process; or
    (B) Substantial experience may be necessary for analytic test 
performance.
    (3) Reagents and materials preparation--(i) Score 1. (A) Reagents 
and materials are generally stable and reliable; and
    (B) Reagents and materials are prepackaged, or premeasured, or 
require no special handling, precautions or storage conditions.
    (ii) Score 3. (A) Reagents and materials may be labile and may 
require special handling to assure reliability; or
    (B) Reagents and materials preparation may include manual steps such 
as gravimetric or volumetric measurements.
    (4) Characteristics of operational steps--(i) Score 1. Operational 
steps are either automatically executed (such as pipetting, temperature 
monitoring, or timing of steps), or are easily controlled.
    (ii) Score 3. Operational steps in the testing process require close 
monitoring or control, and may require special specimen preparation, 
precise temperature control or timing of procedural steps, accurate 
pipetting, or extensive calculations.
    (5) Calibration, quality control, and proficiency testing 
materials--(i) Score 1. (A) Calibration materials are stable and readily 
available;
    (B) Quality control materials are stable and readily available; and
    (C) External proficiency testing materials, when available, are 
stable.
    (ii) Score 3. (A) Calibration materials, if available, may be 
labile;
    (B) Quality control materials may be labile, or not available; or
    (C) External proficiency testing materials, if available, may be 
labile.
    (6) Test system troubleshooting and equipment maintenance--(i) Score 
1. (A) Test system troubleshooting is automatic or self-correcting, or 
clearly described or requires minimal judgment; and
    (B) Equipment maintenance is provided by the manufacturer, is seldom 
needed, or can easily be performed.
    (ii) Score 3. (A) Troubleshooting is not automatic and requires 
decision-making and direct intervention to resolve most problems; or
    (B) Maintenance requires special knowledge, skills, and abilities.
    (7) Interpretation and judgment--(i) Score 1. (A) Minimal 
interpretation and judgment are required to perform preanalytic, 
analytic and postanalytic processes; and
    (B) Resolution of problems requires limited independent 
interpretation and judgment; and
    (ii) Score 3. (A) Extensive independent interpretation and judgment 
are required to perform the preanalytic, analytic or postanalytic 
processes; and
    (B) Resolution of problems requires extensive interpretation and 
judgment.
    (b) Revisions to the criteria for categorization. The Clinical 
Laboratory Improvement Advisory Committee, as defined in subpart T of 
this part, will conduct reviews upon request of HHS and recommend to HHS 
revisions to the criteria for categorization of tests.
    (c) Process for device/test categorization utilizing the scoring 
system under Sec. 493.17(a). (1)(i) For new commercial test systems, 
assays, or examinations, the manufacturer, as part of its 510(k) and PMA 
application to FDA, will submit supporting data for device/test 
categorization. FDA will determine the complexity category, notify the 
manufacturers directly, and will simultaneously inform both CMS and CDC 
of

[[Page 644]]

the device/test category. FDA will consult with CDC concerning test 
categorization in the following three situations:
    (A) When categorizing previously uncategorized new technology;
    (B) When FDA determines it to be necessary in cases involving a 
request for a change in categorization; and
    (C) If a manufacturer requests review of a categorization decision 
by FDA in accordance with 21 CFR 10.75.
    (ii) Test categorization will be effective as of the notification to 
the applicant.
    (2) For test systems, assays, or examinations not commercially 
available, a laboratory or professional group may submit a written 
request for categorization to PHS. These requests will be forwarded to 
CDC for evaluation; CDC will determine complexity category and notify 
the applicant, CMS, and FDA of the categorization decision. In the case 
of request for a change of category or for previously uncategorized new 
technology, PHS will receive the request application and forward it to 
CDC for categorization.
    (3) A request for recategorization will be accepted for review if it 
is based on new information not previously submitted in a request for 
categorization or recategorization by the same applicant and will not be 
considered more frequently than once per year.
    (4) If a laboratory test system, assay or examination does not 
appear on the lists of tests in the Federal Register notices, it is 
considered to be a test of high complexity until PHS, upon request, 
reviews the matter and notifies the applicant of its decision. Test 
categorization is effective as of the notification to the applicant.
    (5) PHS will publish revisions periodically to the list of moderate 
and high complexity tests in the Federal Register in a notice with 
opportunity for comment.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]



Sec. 493.19  Provider-performed microscopy (PPM) procedures.

    (a) Requirement. To be categorized as a PPM procedure, the procedure 
must meet the criteria specified in paragraph (b) of this section.
    (b) Criteria. Procedures must meet the following specifications:
    (1) The examination must be personally performed by one of the 
following practitioners:
    (i) A physician during the patient's visit on a specimen obtained 
from his or her own patient or from a patient of a group medical 
practice of which the physician is a member or an employee.
    (ii) A midlevel practitioner, under the supervision of a physician 
or in independent practice only if authorized by the State, during the 
patient's visit on a specimen obtained from his or her own patient or 
from a patient of a clinic, group medical practice, or other health care 
provider of which the midlevel practitioner is a member or an employee.
    (iii) A dentist during the patient's visit on a specimen obtained 
from his or her own patient or from a patient of a group dental practice 
of which the dentist is a member or an employee.
    (2) The procedure must be categorized as moderately complex.
    (3) The primary instrument for performing the test is the 
microscope, limited to bright-field or phase-contrast microscopy.
    (4) The specimen is labile or delay in performing the test could 
compromise the accuracy of the test result.
    (5) Control materials are not available to monitor the entire 
testing process.
    (6) Limited specimen handling or processing is required.
    (c) Provider-performed microscopy (PPM) examinations. A laboratory 
may qualify to perform tests under this section if it restricts PPM 
examinations to one or more of the following procedures (or additional 
procedures added to this list as provided under paragraph (d) of this 
section), waived tests and no others:
    (1) All direct wet mount preparations for the presence or absence of 
bacteria, fungi, parasites, and human cellular elements.
    (2) All potassium hydroxide (KOH) preparations.
    (3) Pinworm examinations.
    (4) Fern tests.
    (5) Post-coital direct, qualitative examinations of vaginal or 
cervical mucous.

[[Page 645]]

    (6) Urine sediment examinations.
    (7) Nasal smears for granulocytes.
    (8) Fecal leukocyte examinations.
    (9) Qualitative semen analysis (limited to the presence or absence 
of sperm and detection of motility).
    (d) Revisions to criteria and the list of PPM procedures. (1) The 
CLIAC conducts reviews upon HHS' request and recommends to HHS revisions 
to the criteria for categorization of procedures.
    (2) HHS determines whether a laboratory procedure meets the criteria 
listed under paragraph (b) of this section for a PPM procedure. 
Revisions to the list of PPM procedures proposed by HHS are published in 
the Federal Register as a notice with an opportunity for public comment.
    (e) Laboratory requirements. Laboratories eligible to perform PPM 
examinations must--
    (1) Meet the applicable requirements in subpart C or subpart D, and 
subparts F, H, J, K, and M of this part.
    (2) Be subject to inspection as specified under subpart Q of this 
part.

[60 FR 20044, Apr. 24, 1995; 68 FR 50723, Aug. 22, 2003]



Sec. 493.20  Laboratories performing tests of moderate complexity.

    (a) A laboratory may qualify for a certificate to perform tests of 
moderate complexity provided that it restricts its test performance to 
waived tests or examinations and one or more tests or examinations 
meeting criteria for tests of moderate complexity including the 
subcategory of PPM procedures.
    (b) A laboratory that performs tests or examinations of moderate 
complexity must meet the applicable requirements in subpart C or subpart 
D, and subparts F, H, J, K, M, and Q of this part. Under a registration 
certificate or certificate of compliance, laboratories also performing 
PPM procedures must meet the inspection requirements at Sec. Sec. 
493.1773 and 493.1777.
    (c) If the laboratory also performs waived tests, compliance with 
subparts H, J, K, and M of this part is not applicable to the waived 
tests. However, the laboratory must comply with the requirements in 
Sec. Sec. 493.15(e), 493.1773, and 493.1775.

[60 FR 20044, Apr. 24, 1995, as amended at 68 FR 3702, Jan. 24, 2003; 68 
FR 50723, Aug. 22, 2003]



Sec. 493.25  Laboratories performing tests of high complexity.

    (a) A laboratory must obtain a certificate for tests of high 
complexity if it performs one or more tests that meet the criteria for 
tests of high complexity as specified in Sec. 493.17(a).
    (b) A laboratory performing one or more tests of high complexity 
must meet the applicable requirements of subpart C or subpart D, and 
subparts F, H, J, K, M, and Q of this part.
    (c) If the laboratory also performs tests of moderate complexity, 
the applicable requirements of subparts H, J, K, M, and Q of this part 
must be met. Under a registration certificate or certificate of 
compliance, PPM procedures must meet the inspection requirements at 
Sec. Sec. 493.1773 and 493.1777.
    (d) If the laboratory also performs waived tests, the requirements 
of subparts H, J, K, and M are not applicable to the waived tests. 
However, the laboratory must comply with the requirements in Sec. Sec. 
493.15(e), 493.1773, and 493.1775.

[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995; 68 
FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]



                     Subpart B_Certificate of Waiver

    Source: 57 FR 7142, Feb. 28, 1992, unless otherwise noted.



Sec. 493.35  Application for a certificate of waiver.

    (a) Filing of application. Except as specified in paragraph (b) of 
this section, a laboratory performing only one or more waived tests 
listed in Sec. 493.15 must file a separate application for each 
laboratory location.
    (b) Exceptions. (1) Laboratories that are not at a fixed location, 
that is, laboratories that move from testing site to testing site, such 
as mobile units providing laboratory testing, health screening fairs, or 
other temporary testing locations may be covered under

[[Page 646]]

the certificate of the designated primary site or home base, using its 
address.
    (2) Not-for-profit or Federal, State, or local government 
laboratories that engage in limited (not more than a combination of 15 
moderately complex or waived tests per certificate) public health 
testing may file a single application.
    (3) Laboratories within a hospital that are located at contiguous 
buildings on the same campus and under common direction may file a 
single application or multiple applications for the laboratory sites 
within the same physical location or street address.
    (c) Application format and contents. The application must--
    (1) Be made to HHS or its designee on a form or forms prescribed by 
HHS;
    (2) Be signed by an owner, or by an authorized representative of the 
laboratory who attests that the laboratory will be operated in 
accordance with requirements established by the Secretary under section 
353 of the PHS Act; and
    (3) Describe the characteristics of the laboratory operation and the 
examinations and other test procedures performed by the laboratory 
including--
    (i) The name and the total number of test procedures and 
examinations performed annually (excluding tests the laboratory may run 
for quality control, quality assurance or proficiency testing purposes;
    (ii) The methodologies for each laboratory test procedure or 
examination performed, or both; and
    (iii) The qualifications (educational background, training, and 
experience) of the personnel directing and supervising the laboratory 
and performing the laboratory examinations and test procedures.
    (d) Access requirements. Laboratories that perform one or more 
waived tests listed in Sec. 493.15(c) and no other tests must meet the 
following conditions:
    (1) Make records available and submit reports to HHS as HHS may 
reasonably require to determine compliance with this section and Sec. 
493.15(e);
    (2) Agree to permit announced and unannounced inspections by HHS in 
accordance with subpart Q of this part under the following 
circumstances:
    (i) When HHS has substantive reason to believe that the laboratory 
is being operated in a manner that constitutes an imminent and serious 
risk to human health.
    (ii) To evaluate complaints from the public.
    (iii) On a random basis to determine whether the laboratory is 
performing tests not listed in Sec. 493.15.
    (iv) To collect information regarding the appropriateness of waiver 
of tests listed in Sec. 493.15.
    (e) Denial of application. If HHS determines that the application 
for a certificate of waiver is to be denied, HHS will--
    (1) Provide the laboratory with a written statement of the grounds 
on which the denial is based and an opportunity for appeal, in 
accordance with the procedures set forth in subpart R of this part;
    (2) Notify a laboratory that has its application for a certificate 
of waiver denied that it cannot operate as a laboratory under the PHS 
Act unless the denial is overturned at the conclusion of the 
administrative appeals process provided by subpart R; and
    (3) Notify the laboratory that it is not eligible for payment under 
the Medicare and Medicaid programs.

[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60 
FR 20044, Apr. 24, 1995]



Sec. 493.37  Requirements for a certificate of waiver.

    (a) HHS will issue a certificate of waiver to a laboratory only if 
the laboratory meets the requirements of Sec. 493.35.
    (b) Laboratories issued a certificate of waiver--
    (1) Are subject to the requirements of this subpart and Sec. 
493.15(e) of subpart A of this part; and
    (2) Must permit announced or unannounced inspections by HHS in 
accordance with subpart Q of this part.
    (c) Laboratories must remit the certificate of waiver fee specified 
in subpart F of this part.
    (d) In accordance with subpart R of this part, HHS will suspend or 
revoke or limit a laboratory's certificate of waiver for failure to 
comply with the

[[Page 647]]

requirements of this subpart. In addition, failure to meet the 
requirements of this subpart will result in suspension or denial of 
payments under Medicare and Medicaid in accordance with subpart R of 
this part.
    (e)(1) A certificate of waiver issued under this subpart is valid 
for no more than 2 years. In the event of a non-compliance determination 
resulting in HHS action to revoke, suspend, or limit the laboratory's 
certificate of waiver, HHS will provide the laboratory with a statement 
of grounds on which the determination of non-compliance is based and 
offer an opportunity for appeal as provided in subpart R of this part.
    (2) If the laboratory requests a hearing within the time specified 
by HHS, it retains its certificate of waiver or reissued certificate of 
waiver until a decision is made by an administrative law judge, as 
specified in subpart R of this part, except when HHS finds that 
conditions at the laboratory pose an imminent and serious risk to human 
health.
    (3) For laboratories receiving payment from the Medicare or Medicaid 
program, such payments will be suspended on the effective date specified 
in the notice to the laboratory of a non-compliance determination even 
if there has been no appeals decision issued.
    (f) A laboratory seeking to renew its certificate of waiver must--
    (1) Complete the renewal application prescribed by HHS and return it 
to HHS not less than 9 months nor more than 1 year before the expiration 
of the certificate; and
    (2) Meet the requirements of Sec. Sec. 493.35 and 493.37.
    (g) A laboratory with a certificate of waiver that wishes to perform 
examinations or tests not listed in the waiver test category must meet 
the requirements set forth in subpart C or subpart D of this part, as 
applicable.

[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60 
FR 20045, Apr. 24, 1995]



Sec. 493.39  Notification requirements for laboratories issued a
certificate of waiver.

    Laboratories performing one or more tests listed in Sec. 493.15 and 
no others must notify HHS or its designee--
    (a) Before performing and reporting results for any test or 
examination that is not specified under Sec. 493.15 for which the 
laboratory does not have the appropriate certificate as required in 
subpart C or subpart D of this part, as applicable; and
    (b) Within 30 days of any change(s) in--
    (1) Ownership;
    (2) Name;
    (3) Location; or
    (4) Director.

[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]



Sec. 493.41  Condition: Reporting of SARS-CoV-2 test results.

    During the Public Health Emergency, as defined in Sec. 400.200 of 
this chapter, each laboratory that performs a test that is intended to 
detect SARS-CoV-2 or to diagnose a possible case of COVID-19 
(hereinafter referred to as a ``SARS-CoV-2 test'') must report SARS-CoV-
2 test results to the Secretary in such form and manner, and at such 
timing and frequency, as the Secretary may prescribe.

[85 FR 54873, Sept. 2, 2020]



 Subpart C_Registration Certificate, Certificate for Provider-performed 
          Microscopy Procedures, and Certificate of Compliance

    Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.



Sec. 493.43  Application for registration certificate, certificate 
for provider-performed microscopy (PPM) procedures, and certificate 
of compliance.

    (a) Filing of application. Except as specified in paragraph (b) of 
this section, all laboratories performing nonwaived testing must file a 
separate application for each laboratory location.

[[Page 648]]

    (b) Exceptions. (1) Laboratories that are not at a fixed location, 
that is, laboratories that move from testing site to testing site, such 
as mobile units providing laboratory testing, health screening fairs, or 
other temporary testing locations may be covered under the certificate 
of the designated primary site or home base, using its address.
    (2) Not-for-profit or Federal, State, or local government 
laboratories that engage in limited (not more than a combination of 15 
moderately complex or waived tests per certificate) public health 
testing may file a single application.
    (3) Laboratories within a hospital that are located at contiguous 
buildings on the same campus and under common direction may file a 
single application or multiple applications for the laboratory sites 
within the same physical location or street address.
    (c) Application format and contents. The application must--(1) Be 
made to HHS or its designee on a form or forms prescribed by HHS;
    (2) Be signed by an owner, or by an authorized representative of the 
laboratory who attests that the laboratory will be operated in 
accordance with the requirements established by the Secretary under 
section 353 of the Public Health Service Act; and
    (3) Describe the characteristics of the laboratory operation and the 
examinations and other test procedures performed by the laboratory 
including--
    (i) The name and total number of test procedures and examinations 
performed annually (excluding waived tests or tests for quality control, 
quality assurance or proficiency testing purposes);
    (ii) The methodologies for each laboratory test procedure or 
examination performed, or both;
    (iii) The qualifications (educational background, training, and 
experience) of the personnel directing and supervising the laboratory 
and performing the examinations and test procedures.
    (d) Access and reporting requirements. All laboratories must make 
records available and submit reports to HHS as HHS may reasonably 
require to determine compliance with this section.

[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 58 
FR 39155, July 22, 1993; 60 FR 20045, Apr. 24, 1995; 68 FR 3702, Jan. 
24, 2003]



Sec. 493.45  Requirements for a registration certificate.

    Laboratories performing only waived tests, PPM procedures, or any 
combination of these tests, are not required to obtain a registration 
certificate.
    (a) A registration certificate is required--(1) Initially for all 
laboratories performing test procedures of moderate complexity (other 
than the subcategory of PPM procedures) or high complexity, or both; and
    (2) For all laboratories that have been issued a certificate of 
waiver or certificate for PPM procedures that intend to perform tests of 
moderate or high complexity, or both, in addition to those tests listed 
in Sec. 493.15(c) or specified as PPM procedures.
    (b) HHS will issue a registration certificate if the laboratory--
    (1) Complies with the requirements of Sec. 493.43;
    (2) Agrees to notify HHS or its designee within 30 days of any 
changes in ownership, name, location, director or technical supervisor 
(laboratories performing high complexity testing only);
    (3) Agrees to treat proficiency testing samples in the same manner 
as it treats patient specimens; and
    (4) Remits the fee for the registration certificate, as specified in 
subpart F of this part.
    (c) Prior to the expiration of the registration certificate, a 
laboratory must--
    (1) Remit the certificate fee specified in subpart F of this part;
    (2) Be inspected by HHS as specified in subpart Q of this part; and
    (3) Demonstrate compliance with the applicable requirements of this 
subpart and subparts H, J, K, M, and Q of this part.
    (d) In accordance with subpart R of this part, HHS will initiate 
suspension or revocation of a laboratory's registration certificate and 
will deny the

[[Page 649]]

laboratory's application for a certificate of compliance for failure to 
comply with the requirements set forth in this subpart. HHS may also 
impose certain alternative sanctions. In addition, failure to meet the 
requirements of this subpart will result in suspension of payments under 
Medicare and Medicaid as specified in subpart R of this part.
    (e) A registration certificate is--
    (1) Valid for a period of no more than two years or until such time 
as an inspection to determine program compliance can be conducted, 
whichever is shorter; and
    (2) Not renewable; however, the registration certificate may be 
reissued if compliance has not been determined by HHS prior to the 
expiration date of the registration certificate.
    (f) In the event of a noncompliance determination resulting in an 
HHS denial of a laboratory's certificate of compliance application, HHS 
will provide the laboratory with a statement of grounds on which the 
noncompliance determination is based and offer an opportunity for appeal 
as provided in subpart R.
    (g) If the laboratory requests a hearing within the time specified 
by HHS, it retains its registration certificate or reissued registration 
certificate until a decision is made by an administrative law judge as 
provided in subpart R of this part, except when HHS finds that 
conditions at the laboratory pose an imminent and serious risk to human 
health.
    (h) For laboratories receiving payment from the Medicare or Medicaid 
program, such payments will be suspended on the effective date specified 
in the notice to the laboratory of denial of the certificate application 
even if there has been no appeals decision issued.

[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5223, Jan. 19, 1993; 60 
FR 20045, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003]



Sec. 493.47  Requirements for a certificate for provider-performed
microscopy (PPM) procedures.

    (a) A certificate for PPM procedures is required--
    (1) Initially for all laboratories performing test procedures 
specified as PPM procedures; and
    (2) For all certificate of waiver laboratories that intend to 
perform only test procedures specified as PPM procedures in addition to 
those tests listed in Sec. 493.15(c).
    (b) HHS will issue a certificate for PPM procedures if the 
laboratory--
    (1) Complies with the requirements of Sec. 493.43; and
    (2) Remits the fee for the certificate, as specified in subpart F of 
this part.
    (c) Laboratories issued a certificate for PPM procedures are subject 
to--
    (1) The notification requirements of Sec. 493.53;
    (2) The applicable requirements of this subpart and subparts H, J, 
K, and M of this part; and
    (3) Inspection only under the circumstances specified under 
Sec. Sec. 493.1773 and 493.1775, but are not routinely inspected to 
determine compliance with the requirements specified in paragraphs (c) 
(1) and (2) of this section.
    (d) In accordance with subpart R of this part, HHS will initiate 
suspension, limitation, or revocation of a laboratory's certificate for 
PPM procedures for failure to comply with the applicable requirements 
set forth in this subpart. HHS may also impose certain alternative 
sanctions. In addition, failure to meet the requirements of this subpart 
may result in suspension of all or part of payments under Medicare and 
Medicaid, as specified in subpart R of this part.
    (e) A certificate for PPM procedures is valid for a period of no 
more than 2 years.

[58 FR 5223, Jan. 19, 1993, as amended at 60 FR 20045, Apr. 24, 1995; 68 
FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]



Sec. 493.49  Requirements for a certificate of compliance.

    A certificate of compliance may include any combination of tests 
categorized as high complexity or moderate complexity or listed in Sec. 
493.15(c) as waived tests. Moderate complexity tests may include those 
specified as PPM procedures.
    (a) HHS will issue a certificate of compliance to a laboratory only 
if the laboratory--
    (1) Meets the requirements of Sec. Sec. 493.43 and 493.45;

[[Page 650]]

    (2) Remits the certificate fee specified in subpart F of this part; 
and
    (3) Meets the applicable requirements of this subpart and subparts 
H, J, K, M, and Q of this part.
    (b) Laboratories issued a certificate of compliance--
    (1) Are subject to the notification requirements of Sec. 493.51; 
and
    (2) Must permit announced or unannounced inspections by HHS in 
accordance with subpart Q of this part--
    (i) To determine compliance with the applicable requirements of this 
part;
    (ii) To evaluate complaints;
    (iii) When HHS has substantive reason to believe that tests are 
being performed, or the laboratory is being operated in a manner that 
constitutes an imminent and serious risk to human health; and
    (iv) To collect information regarding the appropriateness of tests 
listed in Sec. 493.15 or tests categorized as moderate complexity 
(including the subcategory) or high complexity.
    (c) Failure to comply with the requirements of this subpart will 
result in--
    (1) Suspension, revocation or limitation of a laboratory's 
certificate of compliance in accordance with subpart R of this part; and
    (2) Suspension or denial of payments under Medicare and Medicaid in 
accordance with subpart R of this part.
    (d) A certificate of compliance issued under this subpart is valid 
for no more than 2 years.
    (e) In the event of a noncompliance determination resulting in an 
HHS action to revoke, suspend or limit the laboratory's certificate of 
compliance, HHS will--
    (1) Provide the laboratory with a statement of grounds on which the 
determination of noncompliance is based; and
    (2) Offer an opportunity for appeal as provided in subpart R of this 
part. If the laboratory requests a hearing within 60 days of the notice 
of sanction, it retains its certificate of compliance or reissued 
certificate of compliance until a decision is made by an administrative 
law judge (ALJ) as provided in subpart R of this part, except when HHS 
finds that conditions at the laboratory pose an imminent and serious 
risk to human health or when the criteria at Sec. 493.1840(a) (4) and 
(5) are met.
    (f) For laboratories receiving payment from the Medicare or Medicaid 
program, such payments will be suspended on the effective date specified 
in the notice to the laboratory of a noncompliance determination even if 
there has been no appeals decision issued.
    (g) A laboratory seeking to renew its certificate of compliance 
must--
    (1) Complete and return the renewal application to HHS 9 to 12 
months prior to the expiration of the certificate of compliance; and
    (2) Meet the requirements of Sec. 493.43 and paragraphs (a)(2) and 
(b)(2) of this section.
    (h) If HHS determines that the application for the renewal of a 
certificate of compliance must be denied or limited, HHS will notify the 
laboratory in writing of the--
    (1) Basis for denial of the application; and
    (2) Opportunity for appeal as provided in subpart R of this part.
    (i) If the laboratory requests a hearing within the time period 
specified by HHS, the laboratory retains its certificate of compliance 
or reissued certificate of compliance until a decision is made by an ALJ 
as provided in subpart R, except when HHS finds that conditions at the 
laboratory pose an imminent and serious risk to human health.
    (j) For laboratories receiving payment from the Medicare or Medicaid 
program, such payments will be suspended on the effective date specified 
in the notice to the laboratory of nonrenewal of the certificate of 
compliance even if there has been no appeals decision issued.

[60 FR 20045, Apr. 24, 1995, as amended at 68 FR 3702, Jan. 24, 2003]



Sec. 493.51  Notification requirements for laboratories issued
a certificate of compliance.

    Laboratories issued a certificate of compliance must meet the 
following conditions:
    (a) Notify HHS or its designee within 30 days of any change in--
    (1) Ownership;
    (2) Name;
    (3) Location;

[[Page 651]]

    (4) Director; or
    (5) Technical supervisor (laboratories performing high complexity 
only).
    (b) Notify HHS no later than 6 months after performing any test or 
examination within a specialty or subspecialty area that is not included 
on the laboratory's certificate of compliance, so that compliance with 
requirements can be determined.
    (c) Notify HHS no later than 6 months after any deletions or changes 
in test methodologies for any test or examination included in a 
specialty or subspecialty, or both, for which the laboratory has been 
issued a certificate of compliance.

[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]



Sec. 493.53  Notification requirements for laboratories issued
a certificate for provider-performed microscopy (PPM) procedures.

    Laboratories issued a certificate for PPM procedures must notify HHS 
or its designee--
    (a) Before performing and reporting results for any test of moderate 
or high complexity, or both, in addition to tests specified as PPM 
procedures or any test or examination that is not specified under Sec. 
493.15(c), for which it does not have a registration certificate as 
required in subpart C or subpart D, as applicable, of this part; and
    (b) Within 30 days of any change in--
    (1) Ownership;
    (2) Name;
    (3) Location; or
    (4) Director.

[58 FR 5224, Jan. 19, 1993, as amended at 60 FR 20046, Apr. 24, 1995]



                 Subpart D_Certificate of Accreditation

    Source: 57 FR 7144, Feb. 28, 1992, unless otherwise noted.



Sec. 493.55  Application for registration certificate and certificate
of accreditation.

    (a) Filing of application. A laboratory may be issued a certificate 
of accreditation in lieu of the applicable certificate specified in 
subpart B or subpart C of this part provided the laboratory--
    (1) Meets the standards of a private non-profit accreditation 
program approved by HHS in accordance with subpart E; and
    (2) Files a separate application for each location, except as 
specified in paragraph (b) of this section.
    (b) Exceptions. (1) Laboratories that are not at fixed locations, 
that is, laboratories that move from testing site to testing site, such 
as mobile units providing laboratory testing, health screening fairs, or 
other temporary testing locations may be covered under the certificate 
of the designated primary site or home base, using its address.
    (2) Not-for-profit or Federal, State, or local government 
laboratories that engage in limited (not more than a combination of 15 
moderately complex or waived tests per certificate) public health 
testing may file a single application.
    (3) Laboratories within a hospital that are located at contiguous 
buildings on the same campus and under common direction may file a 
single application or multiple applications for the laboratory sites 
within the same physical location or street address.
    (c) Application format and contents. The application must--(1) Be 
made to HHS on a form or forms prescribed by HHS;
    (2) Be signed by an owner or authorized representative of the 
laboratory who attests that the laboratory will be operated in 
accordance with the requirements established by the Secretary under 
section 353 of the Public Health Service Act; and
    (3) Describe the characteristics of the laboratory operation and the 
examinations and other test procedures performed by the laboratory 
including--
    (i) The name and total number of tests and examinations performed 
annually (excluding waived tests and tests for quality control, quality 
assurance or proficiency testing purposes);
    (ii) The methodologies for each laboratory test procedure or 
examination performed, or both; and
    (iii) The qualifications (educational background, training, and 
experience) of the personnel directing and supervising the laboratory 
and performing

[[Page 652]]

the laboratory examinations and test procedures.
    (d) Access and reporting requirements. All laboratories must make 
records available and submit reports to HHS as HHS may reasonably 
require to determine compliance with this section.

[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993; 58 
FR 39155, July 22, 1993; 60 FR 20046, Apr. 24, 1995]



Sec. 493.57  Requirements for a registration certificate.

    A registration certificate is required for all laboratories seeking 
a certificate of accreditation, unless the laboratory holds a valid 
certificate of compliance issued by HHS.
    (a) HHS will issue a registration certificate if the laboratory--
    (1) Complies with the requirements of Sec. 493.55;
    (2) Agrees to notify HHS within 30 days of any changes in ownership, 
name, location, director, or supervisor (laboratories performing high 
complexity testing only);
    (3) Agrees to treat proficiency testing samples in the same manner 
as it treats patient specimens; and
    (4) Remits the fee for the registration certificate specified in 
subpart F of this part.
    (b)(1) The laboratory must provide HHS with proof of accreditation 
by an approved accreditation program--
    (i) Within 11 months of issuance of the registration certificate; or
    (ii) Prior to the expiration of the certificate of compliance.
    (2) If such proof of accreditation is not supplied within this 
timeframe, the laboratory must meet, or continue to meet, the 
requirements of Sec. 493.49.
    (c) In accordance with subpart R of this part, HHS will initiate 
suspension, revocation, or limitation of a laboratory's registration 
certificate and will deny the laboratory's application for a certificate 
of accreditation for failure to comply with the requirements set forth 
in this subpart. In addition, failure to meet the requirements of this 
subpart will result in suspension or denial of payments under Medicare 
and Medicaid as specified in subpart R of this part.
    (d) A registration certificate is valid for a period of no more than 
2 years. However, it may be reissued if the laboratory is subject to 
subpart C of this part, as specified in Sec. 493.57(b)(2) and 
compliance has not been determined by HHS before the expiration date of 
the registration certificate.
    (e) In the event that the laboratory does not meet the requirements 
of this subpart, HHS will--
    (1) Deny a laboratory's request for certificate of accreditation;
    (2) Notify the laboratory if it must meet the requirements for a 
certificate as defined in subpart C of this part;
    (3) Provide the laboratory with a statement of grounds on which the 
application denial is based;
    (4) Offer an opportunity for appeal on the application denial as 
provided in subpart R of this part. If the laboratory requests a hearing 
within the time specified by HHS, the laboratory will retain its 
registration certificate or reissued registration certificate until a 
decision is made by an administrative law judge as provided in subpart 
R, unless HHS finds that conditions at the laboratory pose an imminent 
and serious risk to human health; and
    (5) For those laboratories receiving payment from the Medicare or 
Medicaid program, such payments will be suspended on the effective date 
specified in the notice to the laboratory of denial of the request even 
if there has been no appeals decision issued.

[57 FR 7144, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]



Sec. 493.61  Requirements for a certificate of accreditation.

    (a) HHS will issue a certificate of accreditation to a laboratory if 
the laboratory--
    (1) Meets the requirements of Sec. 493.57 or, if applicable, Sec. 
493.49 of subpart C of this part; and
    (2) Remits the certificate of accreditation fee specified in subpart 
F of this part.
    (b) Laboratories issued a certificate of accreditation must--
    (1) Treat proficiency testing samples in the same manner as patient 
samples;
    (2) Meet the requirements of Sec. 493.63;
    (3) Comply with the requirements of the approved accreditation 
program;

[[Page 653]]

    (4) Permit random sample validation and complaint inspections as 
required in subpart Q of this part;
    (5) Permit HHS to monitor the correction of any deficiencies found 
through the inspections specified in paragraph (b)(4) of this section;
    (6) Authorize the accreditation program to release to HHS the 
laboratory's inspection findings whenever HHS conducts random sample or 
complaint inspections; and
    (7) Authorize its accreditation program to submit to HHS the results 
of the laboratory's proficiency testing.
    (c) A laboratory failing to meet the requirements of this section--
    (1) Will no longer meet the requirements of this part by virtue of 
its accreditation in an approved accreditation program;
    (2) Will be subject to full determination of compliance by HHS;
    (3) May be subject to suspension, revocation or limitation of the 
laboratory's certificate of accreditation or certain alternative 
sanctions; and
    (4) May be subject to suspension of payments under Medicare and 
Medicaid as specified in subpart R.
    (d) A certificate of accreditation issued under this subpart is 
valid for no more than 2 years. In the event of a non-compliance 
determination as a result of a random sample validation or complaint 
inspection, a laboratory will be subject to a full review by HHS in 
accordance with Sec. 488.11 of this chapter.
    (e) Failure to meet the applicable requirements of part 493, will 
result in an action by HHS to suspend, revoke or limit the certificate 
of accreditation. HHS will--
    (1) Provide the laboratory with a statement of grounds on which the 
determination of noncompliance is based;
    (2) Notify the laboratory if it is eligible to apply for a 
certificate as defined in subpart C of this part; and
    (3) Offer an opportunity for appeal as provided in subpart R of this 
part.
    (f) If the laboratory requests a hearing within the time frame 
specified by HHS--
    (1) It retains its certificate of accreditation or reissued 
certificate of accreditation until a decision is made by an 
administrative law judge as provided in subpart R of this part, unless 
HHS finds that conditions at the laboratory pose an imminent and serious 
risk to human health; and
    (2) For those laboratories receiving payments from the Medicare or 
Medicaid program, such payments will be suspended on the effective date 
specified in the notice to the laboratory even if there has been no 
appeals decision issued.
    (g) In the event the accreditation organization's approval is 
removed by HHS, the laboratory will be subject to the applicable 
requirements of subpart C of this part or Sec. 493.57.
    (h) A laboratory seeking to renew its certificate of accreditation 
must--
    (1) Complete and return the renewal application to HHS 9 to 12 
months prior to the expiration of the certificate of accreditation;
    (2) Meet the requirements of this subpart; and
    (3) Submit the certificate of accreditation fee specified in subpart 
F of this part.
    (i) If HHS determines that the renewal application for a certificate 
of accreditation is to be denied or limited, HHS will notify the 
laboratory in writing of--
    (1) The basis for denial of the application;
    (2) Whether the laboratory is eligible for a certificate as defined 
in subpart C of this part;
    (3) The opportunity for appeal on HHS's action to deny the renewal 
application for certificate of accreditation as provided in subpart R of 
this part. If the laboratory requests a hearing within the time frame 
specified by HHS, it retains its certificate of accreditation or 
reissued certificate of accreditation until a decision is made by an 
administrative law judge as provided in subpart R of this part, unless 
HHS finds that conditions at the laboratory pose an imminent and serious 
risk to human health; and
    (4) Suspension of payments under Medicare or Medicaid for those 
laboratories receiving payments under the Medicare or Medicaid programs.

[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993]

[[Page 654]]



Sec. 493.63  Notification requirements for laboratories issued
a certificate of accreditation.

    Laboratories issued a certificate of accreditation must:
    (a) Notify HHS and the approved accreditation program within 30 days 
of any changes in--
    (1) Ownership;
    (2) Name;
    (3) Location; or
    (4) Director.
    (b) Notify the approved accreditation program no later than 6 months 
after performing any test or examination within a specialty or 
subspecialty area that is not included in the laboratory's 
accreditation, so that the accreditation organization can determine 
compliance and a new certificate of accreditation can be issued.
    (c) Notify the accreditation program no later than 6 months after of 
any deletions or changes in test methodologies for any test or 
examination included in a specialty or subspecialty, or both, for which 
the laboratory has been issued a certificate of accreditation.



     Subpart E_Accreditation by a Private, Nonprofit Accreditation 
  Organization or Exemption Under an Approved State Laboratory Program

    Source: 63 FR 26732, May 14, 1998, unless otherwise noted.



Sec. 493.551  General requirements for laboratories.

    (a) Applicability. CMS may deem a laboratory to meet all applicable 
CLIA program requirements through accreditation by a private nonprofit 
accreditation program (that is, grant deemed status), or may exempt from 
CLIA program requirements all State licensed or approved laboratories in 
a State that has a State licensure program established by law, if the 
following conditions are met:
    (1) The requirements of the accreditation organization or State 
licensure program are equal to, or more stringent than, the CLIA 
condition-level requirements specified in this part, and the laboratory 
would meet the condition-level requirements if it were inspected against 
these requirements.
    (2) The accreditation program or the State licensure program meets 
the requirements of this subpart and is approved by CMS.
    (3) The laboratory authorizes the approved accreditation 
organization or State licensure program to release to CMS all records 
and information required and permits inspections as outlined in this 
part.
    (b) Meeting CLIA requirements by accreditation. A laboratory seeking 
to meet CLIA requirements through accreditation by an approved 
accreditation organization must do the following:
    (1) Obtain a certificate of accreditation as required in subpart D 
of this part.
    (2) Pay the applicable fees as required in subpart F of this part.
    (3) Meet the proficiency testing (PT) requirements in subpart H of 
this part.
    (4) Authorize its PT organization to furnish to its accreditation 
organization the results of the laboratory's participation in an 
approved PT program for the purpose of monitoring the laboratory's PT 
and for making the annual PT results, along with explanatory information 
required to interpret the PT results, available on a reasonable basis, 
upon request of any person. A laboratory that refuses to authorize 
release of its PT results is no longer deemed to meet the condition-
level requirements and is subject to a full review by CMS, in accordance 
with subpart Q of this part, and may be subject to the suspension or 
revocation of its certificate of accreditation under Sec. 493.1840.
    (5) Authorize its accreditation organization to release to CMS or a 
CMS agent the laboratory's PT results that constitute unsuccessful 
participation in an approved PT program, in accordance with the 
definition of ``unsuccessful participation in an approved PT program,'' 
as specified in Sec. 493.2 of this part, when the laboratory has failed 
to achieve successful participation in an approved PT program.
    (6) Authorize its accreditation organization to release to CMS a 
notification of the actions taken by the organization as a result of the 
unsuccessful

[[Page 655]]

participation in a PT program within 30 days of the initiation of the 
action. Based on this notification, CMS may take an adverse action 
against a laboratory that fails to participate successfully in an 
approved PT program.
    (c) Withdrawal of laboratory accreditation. After an accreditation 
organization has withdrawn or revoked its accreditation of a laboratory, 
the laboratory retains its certificate of accreditation for 45 days 
after the laboratory receives notice of the withdrawal or revocation of 
the accreditation, or the effective date of any action taken by CMS, 
whichever is earlier.



Sec. 493.553  Approval process (application and reapplication) for 
accreditation organizations and State licensure programs.

    (a) Information required. An accreditation organization that applies 
or reapplies to CMS for deeming authority, or a State licensure program 
that applies or reapplies to CMS for exemption from CLIA program 
requirements of licensed or approved laboratories within the State, must 
provide the following information:
    (1) A detailed comparison of the individual accreditation, or 
licensure or approval requirements with the comparable condition-level 
requirements; that is, a crosswalk.
    (2) A detailed description of the inspection process, including the 
following:
    (i) Frequency of inspections.
    (ii) Copies of inspection forms.
    (iii) Instructions and guidelines.
    (iv) A description of the review and decision-making process of 
inspections.
    (v) A statement concerning whether inspections are announced or 
unannounced.
    (vi) A description of the steps taken to monitor the correction of 
deficiencies.
    (3) A description of the process for monitoring PT performance, 
including action to be taken in response to unsuccessful participation 
in a CMS-approved PT program.
    (4) Procedures for responding to and for the investigation of 
complaints against its laboratories.
    (5) A list of all its current laboratories and the expiration date 
of their accreditation or licensure, as applicable.
    (6) Procedures for making PT information available (under State 
confidentiality and disclosure requirements, if applicable) including 
explanatory information required to interpret PT results, on a 
reasonable basis, upon request of any person.
    (b) CMS action on an application or reapplication. If CMS receives 
an application or reapplication from an accreditation organization, or 
State licensure program, CMS takes the following actions:
    (1) CMS determines if additional information is necessary to make a 
determination for approval or denial of the application and notifies the 
accreditation organization or State to afford it an opportunity to 
provide the additional information.
    (2) CMS may visit the accreditation organization or State licensure 
program offices to review and verify the policies and procedures 
represented in its application and other information, including, but not 
limited to, review and examination of documents and interviews with 
staff.
    (3) CMS notifies the accreditation organization or State licensure 
program indicating whether CMS approves or denies the request for 
deeming authority or exemption, respectively, and the rationale for any 
denial.
    (c) Duration of approval. CMS approval may not exceed 6 years.
    (d) Withdrawal of application. The accreditation organization or 
State licensure program may withdraw its application at any time before 
official notification, specified at Sec. 493.553(b)(3).



Sec. 493.555  Federal review of laboratory requirements.

    CMS's review of an accreditation organization or State licensure 
program includes, but is not limited to, an evaluation of the following:
    (a) Whether the organization's or State's requirements for 
laboratories are equal to, or more stringent than, the condition-level 
requirements for laboratories.
    (b) The organization's or State's inspection process to determine 
the comparability of the full inspection and complaint inspection 
procedures and

[[Page 656]]

requirements to those of CMS, including, but not limited to, inspection 
frequency and the ability to investigate and respond to complaints 
against its laboratories.
    (c) The organization's or State's agreement with CMS that requires 
it to do the following:
    (1) Notify CMS within 30 days of the action taken, of any laboratory 
that has--
    (i) Had its accreditation or licensure suspended, withdrawn, 
revoked, or limited;
    (ii) In any way been sanctioned; or
    (iii) Had any adverse action taken against it.
    (2) Notify CMS within 10 days of any deficiency identified in an 
accredited or CLIA-exempt laboratory if the deficiency poses an 
immediate jeopardy to the laboratory's patients or a hazard to the 
general public.
    (3) Notify CMS, within 30 days, of all newly--
    (i) Accredited laboratories (or laboratories whose areas of 
specialty/subspecialty testing have changed); or
    (ii) Licensed laboratories, including the specialty/subspecialty 
areas of testing.
    (4) Notify each accredited or licensed laboratory within 10 days of 
CMS's withdrawal of the organization's deeming authority or State's 
exemption.
    (5) Provide CMS with inspection schedules, as requested, for 
validation purposes.
    (6) Notify CMS within 10 days of any conditional level deficiency 
under Sec. Sec. 493.41 or 493.1100(a).

[63 FR 26732, May 14, 1998, as amended at 85 FR 54873, Sept. 2, 2020]



Sec. 493.557  Additional submission requirements.

    (a) Specific requirements for accreditation organizations. In 
addition to the information specified in Sec. Sec. 493.553 and 493.555, 
as part of the approval and review process, an accreditation 
organization applying or reapplying for deeming authority must also 
provide the following:
    (1) The specialty or subspecialty areas for which the organization 
is requesting deeming authority and its mechanism for monitoring 
compliance with all requirements equivalent to condition-level 
requirements within the scope of the specialty or subspecialty areas.
    (2) A description of the organization's data management and analysis 
system with respect to its inspection and accreditation decisions, 
including the kinds of routine reports and tables generated by the 
systems.
    (3) Detailed information concerning the inspection process, 
including, but not limited to the following:
    (i) The size and composition of individual accreditation inspection 
teams.
    (ii) Qualifications, education, and experience requirements that 
inspectors must meet.
    (iii) The content and frequency of training provided to inspection 
personnel, including the ability of the organization to provide 
continuing education and training to inspectors.
    (4) Procedures for removal or withdrawal of accreditation status for 
laboratories that fail to meet the organization's standards.
    (5) A proposed agreement between CMS and the accreditation 
organization with respect to the notification requirements specified in 
Sec. 493.555(c).
    (6) Procedures for monitoring laboratories found to be out of 
compliance with its requirements. (These monitoring procedures must be 
used only when the accreditation organization identifies noncompliance. 
If noncompliance is identified through validation inspections, CMS or a 
CMS agent monitors corrections, as authorized at Sec. 493.565(d)).
    (7) A demonstration of its ability to provide CMS with electronic 
data and reports in compatible code, including the crosswalk specified 
in Sec. 493.553(a)(1), that are necessary for effective validation and 
assessment of the organization's inspection process.
    (8) A demonstration of its ability to provide CMS with electronic 
data, in compatible code, related to the adverse actions resulting from 
PT results constituting unsuccessful participation in PT programs as 
well as data related to the PT failures, within 30 days of the 
initiation of adverse action.
    (9) A demonstration of its ability to provide CMS with electronic 
data, in

[[Page 657]]

compatible code, for all accredited laboratories, including the area of 
specialty or subspecialty.
    (10) Information defining the adequacy of numbers of staff and other 
resources.
    (11) Information defining the organization's ability to provide 
adequate funding for performing required inspections.
    (12) Any facility-specific data, upon request by CMS, which 
includes, but is not limited to, the following:
    (i) PT results that constitute unsuccessful participation in a CMS-
approved PT program.
    (ii) Notification of the adverse actions or corrective actions 
imposed by the accreditation organization as a result of unsuccessful PT 
participation.
    (13) An agreement to provide written notification to CMS at least 30 
days in advance of the effective date of any proposed change in its 
requirements.
    (14) An agreement to disclose any laboratory's PT results upon 
reasonable request by any person.
    (b) Specific requirements for a State licensure program. In addition 
to requirements in Sec. Sec. 493.553 and 493.555, as part of the 
approval and review process, when a State licensure program applies or 
reapplies for exemption from the CLIA program, the State must do the 
following:
    (1) Demonstrate to CMS that it has enforcement authority and 
administrative structures and resources adequate to enforce its 
laboratory requirements.
    (2) Permit CMS or a CMS agent to inspect laboratories in the State.
    (3) Require laboratories in the State to submit to inspections by 
CMS or a CMS agent as a condition of licensure or approval.
    (4) Agree to pay the cost of the validation program administered in 
that State as specified in Sec. Sec. 493.645(a) and 493.646(b).
    (5) Take appropriate enforcement action against laboratories found 
by CMS not to be in compliance with requirements equivalent to CLIA 
requirements.
    (6) Submit for Medicare and Medicaid payment purposes, a list of the 
specialties and subspecialties of tests performed by each laboratory.
    (7) Submit a written presentation that demonstrates the agency's 
ability to furnish CMS with electronic data in compatible code, 
including the crosswalk specified in Sec. 493.553(a)(1).
    (8) Submit a statement acknowledging that the State will notify CMS 
through electronic transmission of the following:
    (i) Any laboratory that has had its licensure or approval revoked or 
withdrawn or has been in any way sanctioned by the State within 30 days 
of taking the action.
    (ii) Changes in licensure or inspection requirements.
    (iii) Changes in specialties or subspecialties under which any 
licensed laboratory in the State performs testing.
    (9) Provide information for the review of the State's enforcement 
procedures for laboratories found to be out of compliance with the 
State's requirements.
    (10) Submit information that demonstrates the ability of the State 
to provide CMS with the following:
    (i) Electronic data and reports in compatible code with the adverse 
or corrective actions resulting from PT results that constitute 
unsuccessful participation in PT programs.
    (ii) Other data that CMS determines are necessary for validation and 
assessment of the State's inspection process requirements.
    (11) Agree to provide CMS with written notification of any changes 
in its licensure/approval and inspection requirements.
    (12) Agree to disclose any laboratory's PT results in accordance 
with a State's confidentiality requirements.
    (13) Agree to take the appropriate enforcement action against 
laboratories found by CMS not to be in compliance with requirements 
comparable to condition-level requirements and report these enforcement 
actions to CMS.
    (14) If approved, reapply to CMS every 2 years to renew its exempt 
status and to renew its agreement to pay the cost of the CMS-
administered validation program in that State.

[[Page 658]]



Sec. 493.559  Publication of approval of deeming authority or CLIA
exemption.

    (a) Notice of deeming authority or exemption. CMS publishes a notice 
in the Federal Register when it grants deeming authority to an 
accreditation organization or exemption to a State licensure program.
    (b) Contents of notice. The notice includes the following:
    (1) The name of the accreditation organization or State licensure 
program.
    (2) For an accreditation organization:
    (i) The specific specialty or subspecialty areas for which it is 
granted deeming authority.
    (ii) A description of how the accreditation organization provides 
reasonable assurance to CMS that a laboratory accredited by the 
organization meets CLIA requirements equivalent to those in this part 
and would meet CLIA requirements if the laboratory had not been granted 
deemed status, but had been inspected against condition-level 
requirements.
    (3) For a State licensure program, a description of how the 
laboratory requirements of the State are equal to, or more stringent 
than, those specified in this part.
    (4) The basis for granting deeming authority or exemption.
    (5) The term of approval, not to exceed 6 years.



Sec. 493.561  Denial of application or reapplication.

    (a) Reconsideration of denial. (1) If CMS denies a request for 
approval, an accreditation organization or State licensure program may 
request, within 60 days of the notification of denial, that CMS 
reconsider its original application or application for renewal, in 
accordance with part 488, subpart D.
    (2) If the accreditation organization or State licensure program 
requests a reconsideration of CMS's determination to deny its request 
for approval or reapproval, it may not submit a new application until 
CMS issues a final reconsideration determination.
    (b) Resubmittal of a request for approval--accreditation 
organization. An accreditation organization may resubmit a request for 
approval if a final reconsideration determination is not pending and the 
accreditation program meets the following conditions:
    (1) It has revised its accreditation program to address the 
rationale for denial of its previous request.
    (2) It demonstrates that it can provide reasonable assurance that 
its accredited facilities meet condition-level requirements.
    (3) It resubmits the application in its entirety.
    (c) Resubmittal of request for approval--State licensure program. 
The State licensure program may resubmit a request for approval if a 
final reconsideration determination is not pending and it has taken the 
necessary action to address the rationale for any previous denial.



Sec. 493.563  Validation inspections--Basis and focus.

    (a) Basis for validation inspection--(1) Laboratory with a 
certificate of accreditation. (i) CMS or a CMS agent may conduct an 
inspection of an accredited laboratory that has been issued a 
certificate of accreditation on a representative sample basis or in 
response to a substantial allegation of noncompliance.
    (ii) CMS uses the results of these inspections to validate the 
accreditation organization's accreditation process.
    (2) Laboratory in a State with an approved State licensure program. 
(i) CMS or a CMS agent may conduct an inspection of any laboratory in a 
State with an approved State licensure program on a representative 
sample basis or in response to a substantial allegation of 
noncompliance.
    (ii) The results of these inspections are used to validate the 
appropriateness of the exemption of that State's licensed or approved 
laboratories from CLIA program requirements.
    (b) Validation inspection conducted on a representative sample 
basis. (1) If CMS or a CMS agent conducts a validation inspection on a 
representative sample basis, the inspection is comprehensive, addressing 
all condition-level requirements, or it may be focused on a specific 
condition-level requirement.
    (2) The number of laboratories sampled is sufficient to allow a 
reasonable estimate of the performance of the accreditation organization 
or State.

[[Page 659]]

    (c) Validation inspection conducted in response to a substantial 
allegation of noncompliance. (1) If CMS or a CMS agent conducts a 
validation inspection in response to a substantial allegation of 
noncompliance, the inspection focuses on any condition-level requirement 
that CMS determines to be related to the allegation.
    (2) If CMS or a CMS agent substantiates a deficiency and determines 
that the laboratory is out of compliance with any condition-level 
requirement, CMS or a CMS agent conducts a full CLIA inspection.
    (d) Inspection of operations and offices. As part of the validation 
review process, CMS may conduct an onsite inspection of the operations 
and offices to verify the following:
    (1) The accreditation organization's representations and to assess 
the accreditation organization's compliance with its own policies and 
procedures.
    (2) The State's representations and to assess the State's compliance 
with its own policies and procedures, including verification of State 
enforcement actions taken on the basis of validation inspections 
performed by CMS or a CMS agent.
    (e) Onsite inspection of an accreditation organization. An onsite 
inspection of an accreditation organization may include, but is not 
limited to, the following:
    (1) A review of documents.
    (2) An audit of meetings concerning the accreditation process.
    (3) Evaluation of accreditation inspection results and the 
accreditation decision-making process.
    (4) Interviews with the accreditation organization's staff.
    (f) Onsite inspection of a State licensure program. An onsite 
inspection of a State licensure program office may include, but is not 
limited to, the following:
    (1) A review of documents.
    (2) An audit of meetings concerning the licensure or approval 
process.
    (3) Evaluation of State inspection results and the licensure or 
approval decision-making process.
    (4) Interviews with State employees.



Sec. 493.565  Selection for validation inspection--laboratory 
responsibilities.

    A laboratory selected for a validation inspection must do the 
following:
    (a) Authorize its accreditation organization or State licensure 
program, as applicable, to release to CMS or a CMS agent, on a 
confidential basis, a copy of the laboratory's most recent full, and any 
subsequent partial inspection.
    (b) Authorize CMS or a CMS agent to conduct a validation inspection.
    (c) Provide CMS or a CMS agent with access to all facilities, 
equipment, materials, records, and information that CMS or a CMS agent 
determines have a bearing on whether the laboratory is being operated in 
accordance with the requirements of this part, and permit CMS or a CMS 
agent to copy material or require the laboratory to submit material.
    (d) If the laboratory possesses a valid certificate of 
accreditation, authorize CMS or a CMS agent to monitor the correction of 
any deficiencies found through the validation inspection.



Sec. 493.567  Refusal to cooperate with validation inspection.

    (a) Laboratory with a certificate of accreditation. (1) A laboratory 
with a certificate of accreditation that refuses to cooperate with a 
validation inspection by failing to comply with the requirements in 
Sec. 493.565--
    (i) Is subject to full review by CMS or a CMS agent, in accordance 
with this part; and
    (ii) May be subject to suspension, revocation, or limitation of its 
certificate of accreditation under this part.
    (2) A laboratory with a certificate of accreditation is again deemed 
to meet the condition-level requirements by virtue of its accreditation 
when the following conditions exist:
    (i) The laboratory withdraws any prior refusal to authorize its 
accreditation organization to release a copy of the laboratory's current 
accreditation inspection, PT results, or notification of any adverse 
actions resulting from PT failure.
    (ii) The laboratory withdraws any prior refusal to allow a 
validation inspection.

[[Page 660]]

    (iii) CMS finds that the laboratory meets all the condition-level 
requirements.
    (b) CLIA-exempt laboratory. If a CLIA-exempt laboratory fails to 
comply with the requirements specified in Sec. 493.565, CMS notifies 
the State of the laboratory's failure to meet the requirements.



Sec. 493.569  Consequences of a finding of noncompliance as a result
of a validation inspection.

    (a) Laboratory with a certificate of accreditation. If a validation 
inspection results in a finding that the accredited laboratory is out of 
compliance with one or more condition-level requirements, the laboratory 
is subject to--
    (1) The same requirements and survey and enforcement processes 
applied to laboratories that are not accredited and that are found out 
of compliance following an inspection under this part; and
    (2) Full review by CMS, in accordance with this part; that is, the 
laboratory is subject to the principal and alternative sanctions in 
Sec. 493.1806.
    (b) CLIA-exempt laboratory. If a validation inspection results in a 
finding that a CLIA-exempt laboratory is out of compliance with one or 
more condition-level requirements, CMS directs the State to take 
appropriate enforcement action.



Sec. 493.571  Disclosure of accreditation, State and CMS validation 
inspection results.

    (a) Accreditation organization inspection results. CMS may disclose 
accreditation organization inspection results to the public only if the 
results are related to an enforcement action taken by the Secretary.
    (b) State inspection results. Disclosure of State inspection results 
is the responsibility of the approved State licensure program, in 
accordance with State law.
    (c) CMS validation inspection results. CMS may disclose the results 
of all validation inspections conducted by CMS or its agent.



Sec. 493.573  Continuing Federal oversight of private nonprofit 
accreditation organizations and approved State licensure programs.

    (a) Comparability review. In addition to the initial review for 
determining equivalency of specified organization or State requirements 
to the comparable condition-level requirements, CMS reviews the 
equivalency of requirements in the following cases:
    (1) When CMS promulgates new condition-level requirements.
    (2) When CMS identifies an accreditation organization or a State 
licensure program whose requirements are no longer equal to, or more 
stringent than, condition-level requirements.
    (3) When an accreditation organization or State licensure program 
adopts new requirements.
    (4) When an accreditation organization or State licensure program 
adopts changes to its inspection process, as required by Sec. 
493.575(b)(1), as applicable.
    (5) Every 6 years, or sooner if CMS determines an earlier review is 
required.
    (b) Validation review. Following the end of a validation review 
period, CMS evaluates the validation inspection results for each 
approved accreditation organization and State licensure program.
    (c) Reapplication procedures. (1) Every 6 years, or sooner, as 
determined by CMS, an approved accreditation organization must reapply 
for continued approval of deeming authority and a State licensure 
program must reapply for continued approval of a CLIA exemption. CMS 
provides notice of the materials that must be submitted as part of the 
reapplication procedure.
    (2) An accreditation organization or State licensure program that 
does not meet the requirements of this subpart, as determined through a 
comparability or validation review, must furnish CMS, upon request, with 
the reapplication materials CMS requests. CMS establishes a deadline by 
which the materials must be submitted.
    (d) Notice. (1) CMS provides written notice, as appropriate, to the 
following:
    (i) An accreditation organization indicating that its approval may 
be in

[[Page 661]]

jeopardy if a comparability or validation review reveals that it is not 
meeting the requirements of this subpart and CMS is initiating a review 
of the accreditation organization's deeming authority.
    (ii) A State licensure program indicating that its CLIA exemption 
may be in jeopardy if a comparability or validation review reveals that 
it is not meeting the requirements of this subpart and that a review is 
being initiated of the CLIA exemption of the State's laboratories.
    (2) The notice contains the following information:
    (i) A statement of the discrepancies that were found as well as 
other related documentation.
    (ii) An explanation of CMS's review process on which the final 
determination is based and a description of the possible actions, as 
specified in Sec. 493.575, that CMS may impose based on the findings 
from the comparability or validation review.
    (iii) A description of the procedures available if the accreditation 
organization or State licensure program, as applicable, desires an 
opportunity to explain or justify the findings made during the 
comparability or validation review.
    (iv) The reapplication materials that the accreditation organization 
or State licensure program must submit and the deadline for that 
submission.



Sec. 493.575  Removal of deeming authority or CLIA exemption and 
final determination review.

    (a) CMS review. CMS conducts a review of the following:
    (1) A deeming authority review of an accreditation organization's 
program if the comparability or validation review produces findings, as 
described at Sec. 493.573. CMS reviews, as appropriate, the criteria 
described in Sec. Sec. 493.555 and 493.557(a) to reevaluate whether the 
accreditation organization continues to meet all these criteria.
    (2) An exemption review of a State's licensure program if the 
comparability or validation review produces findings, as described at 
Sec. 493.573. CMS reviews, as appropriate, the criteria described in 
Sec. Sec. 493.555 and 493.557(b) to reevaluate whether the licensure 
program continues to meet all these criteria.
    (3) A review of an accreditation organization or State licensure 
program, at CMS's discretion, if validation review findings, 
irrespective of the rate of disparity, indicate widespread or systematic 
problems in the organization's accreditation or State's licensure 
process that provide evidence that the requirements, taken as a whole, 
are no longer equivalent to CLIA requirements, taken as a whole.
    (4) A review of the accreditation organization or State licensure 
program whenever validation inspection results indicate a rate of 
disparity of 20 percent or more between the findings of the organization 
or State and those of CMS or a CMS agent for the following periods:
    (i) One year for accreditation organizations.
    (ii) Two years for State licensure programs.
    (b) CMS action after review. Following the review, CMS may take the 
following action:
    (1) If CMS determines that the accreditation organization or State 
has failed to adopt requirements equal to, or more stringent than, CLIA 
requirements, CMS may give a conditional approval for a probationary 
period of its deeming authority to an organization 30 days following the 
date of CMS's determination, or exempt status to a State within 30 days 
of CMS's determination, both not to exceed 1 year, to afford the 
organization or State an opportunity to adopt equal or more stringent 
requirements.
    (2) If CMS determines that there are widespread or systematic 
problems in the organization's or State's inspection process, CMS may 
give conditional approval during a probationary period, not to exceed 1 
year, effective 30 days following the date of the determination.
    (c) Final determination. CMS makes a final determination as to 
whether the organization or State continues to meet the criteria 
described in this subpart and issues a notice that includes the reasons 
for the determination to the organization or State within 60 days after 
the end of any probationary

[[Page 662]]

period. This determination is based on an evaluation of any of the 
following:
    (1) The most recent validation inspection and review findings. To 
continue to be approved, the organization or State must meet the 
criteria of this subpart.
    (2) Facility-specific data, as well as other related information.
    (3) The organization's or State's inspection procedures, surveyors' 
qualifications, ongoing education, training, and composition of 
inspection teams.
    (4) The organization's accreditation requirements, or the State's 
licensure or approval requirements.
    (d) Date of withdrawal of approval. CMS may withdraw its approval of 
the accreditation organization or State licensure program, effective 30 
days from the date of written notice to the organization or State of 
this proposed action, if improvements acceptable to CMS have not been 
made during the probationary period.
    (e) Continuation of validation inspections. The existence of any 
validation review, probationary status, or any other action, such as a 
deeming authority review, by CMS does not affect or limit the conduct of 
any validation inspection.
    (f) Federal Register notice. CMS publishes a notice in the Federal 
Register containing a justification for removing the deeming authority 
from an accreditation organization, or the CLIA-exempt status of a State 
licensure program.
    (g) Withdrawal of approval-effect on laboratory status--(1) 
Accredited laboratory. After CMS withdraws approval of an accreditation 
organization's deeming authority, the certificate of accreditation of 
each affected laboratory continues in effect for 60 days after it 
receives notification of the withdrawal of approval.
    (2) CLIA-exempt laboratory. After CMS withdraws approval of a State 
licensure program, the exempt status of each licensed or approved 
laboratory in the State continues in effect for 60 days after a 
laboratory receives notification from the State of the withdrawal of 
CMS's approval of the program.
    (3) Extension. After CMS withdraws approval of an accreditation 
organization or State licensure program, CMS may extend the period for 
an additional 60 days for a laboratory if it determines that the 
laboratory submitted an application for accreditation to an approved 
accreditation organization or an application for the appropriate 
certificate to CMS or a CMS agent before the initial 60-day period ends.
    (h) Immediate jeopardy to patients. (1) If at any time CMS 
determines that the continued approval of deeming authority of any 
accreditation organization poses immediate jeopardy to the patients of 
the laboratories accredited by the organization, or continued approval 
otherwise constitutes a significant hazard to the public health, CMS may 
immediately withdraw the approval of deeming authority for that 
accreditation organization.
    (2) If at any time CMS determines that the continued approval of a 
State licensure program poses immediate jeopardy to the patients of the 
laboratories in that State, or continued approval otherwise constitutes 
a significant hazard to the public health, CMS may immediately withdraw 
the approval of that State licensure program.
    (i) Failure to pay fees. CMS withdraws the approval of a State 
licensure program if the State fails to pay the applicable fees, as 
specified in Sec. Sec. 493.645(a) and 493.646(b).
    (j) State refusal to take enforcement action. (1) CMS may withdraw 
approval of a State licensure program if the State refuses to take 
enforcement action against a laboratory in that State when CMS 
determines it to be necessary.
    (2) A laboratory that is in a State in which CMS has withdrawn 
program approval is subject to the same requirements and survey and 
enforcement processes that are applied to a laboratory that is not 
exempt from CLIA requirements.
    (k) Request for reconsideration. Any accreditation organization or 
State that is dissatisfied with a determination to withdraw approval of 
its deeming authority or remove approval of its State licensure program, 
as applicable, may request that CMS reconsider the determination, in 
accordance with subpart D of part 488.

[[Page 663]]



                    Subpart F_General Administration

    Source: 57 FR 7138, 7213, Feb. 28, 1992, unless otherwise noted.



Sec. 493.602  Scope of subpart.

    This subpart sets forth the methodology for determining the amount 
of the fees for issuing the appropriate certificate, and for determining 
compliance with the applicable standards of the Public Health Service 
Act (the PHS Act) and the Federal validation of accredited laboratories 
and of CLIA-exempt laboratories.

[60 FR 20047, Apr. 24, 1995]



Sec. 493.606  Applicability of subpart.

    The rules of this subpart are applicable to those laboratories 
specified in Sec. 493.3.

[58 FR 5212, Jan. 19, 1993]



Sec. 493.638  Certificate fees.

    (a) Basic rule. Laboratories must pay a fee for the issuance of a 
registration certificate, certificate for PPM procedures, certificate of 
waiver, certificate of accreditation, or a certificate of compliance, as 
applicable. Laboratories must also pay a fee to reapply for a 
certificate for PPM procedures, certificate of waiver, certificate of 
accreditation, or a certificate of compliance. The total of fees 
collected by HHS under the laboratory program must be sufficient to 
cover the general costs of administering the laboratory certification 
program under section 353 of the PHS Act.
    (1) For registration certificates and certificates of compliance, 
the costs include issuing the certificates, collecting the fees, 
evaluating and monitoring proficiency testing programs, evaluating which 
procedures, tests or examinations meet the criteria for inclusion in the 
appropriate complexity category, and implementing section 353 of the PHS 
Act.
    (2) For a certificate of waiver, the costs include issuing the 
certificate, collecting the fees, determining if a certificate of waiver 
should be issued, evaluating which tests qualify for inclusion in the 
waived category, and other direct administrative costs.
    (3) For a certificate for PPM procedures, the costs include issuing 
the certificate, collecting the fees, determining if a certificate for 
PPM procedures should be issued, evaluating which procedures meet the 
criteria for inclusion in the subcategory of PPM procedures, and other 
direct administrative costs.
    (4) For a certificate of accreditation, the costs include issuing 
the certificate, collecting the fees, evaluating the programs of 
accrediting bodies, and other direct administrative costs.
    (b) Fee amount. The fee amount is set annually by HHS on a calendar 
year basis and is based on the category of test complexity, or on the 
category of test complexity and schedules or ranges of annual laboratory 
test volume (excluding waived tests and tests performed for quality 
control, quality assurance, and proficiency testing purposes) and 
specialties tested, with the amounts of the fees in each schedule being 
a function of the costs for all aspects of general administration of 
CLIA as set forth in Sec. 493.649 (b) and (c). This fee is assessed and 
payable at least biennially. The methodology used to determine the 
amount of the fee is found in Sec. 493.649. The amount of the fee 
applicable to the issuance of the registration certificate or the 
issuance or renewal of the certificate for PPM procedures, certificate 
of waiver, certificate of accreditation, or certificate of compliance is 
the amount in effect at the time the application is received. Upon 
receipt of an application for a certificate, HHS or its designee 
notifies the laboratory of the amount of the required fee for the 
requested certificate.

[60 FR 20047, Apr. 24, 1995]



Sec. 493.639  Fee for revised certificate.

    (a) If, after a laboratory is issued a registration certificate, it 
changes its name or location, the laboratory must pay a fee to cover the 
cost of issuing a revised registration certificate. The fee for the 
revised registration certificate is based on the cost to issue the 
revised certificate to the laboratory.
    (b) A laboratory must pay a fee to cover the cost of issuing a 
revised certificate in any of the following circumstances:

[[Page 664]]

    (1) The fee for issuing an appropriate revised certificate is based 
on the cost to issue the revised certificate to the laboratory as 
follows:
    (i) If a laboratory with a certificate of waiver wishes to perform 
tests in addition to those listed in Sec. 493.15(c) as waived tests, it 
must, as set forth in Sec. 493.638, pay an additional fee for the 
appropriate certificate to cover the additional testing.
    (ii) If a laboratory with a certificate for PPM procedures wishes to 
perform tests in addition to those specified as PPM procedures or listed 
in Sec. 493.15(c) as waived tests, it must, as set forth in Sec. 
493.638, pay an additional fee for the appropriate certificate to cover 
the additional testing.
    (2) A laboratory must pay a fee to cover the cost of issuing a 
revised certificate when--
    (i) A laboratory changes its name, location, or its director; or
    (ii) A laboratory deletes services or wishes to add services and 
requests that its certificate be changed. (An additional fee is also 
required under Sec. 493.643(d) if it is necessary to determine 
compliance with additional requirements.)

[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr. 24, 1995]



Sec. 493.643  Fee for determination of program compliance.

    (a) Fee requirement. In addition to the fee required under Sec. 
493.638, a laboratory subject to routine inspections must pay a fee to 
cover the cost of determining program compliance. Laboratories issued a 
certificate for PPM procedures, certificate of waiver, or a certificate 
of accreditation are not subject to this fee for routine inspections.
    (b) Costs included in the fee. Included in the fee for determining 
program compliance is the cost of evaluating qualifications of 
personnel; monitoring proficiency testing; conducting onsite 
inspections; documenting deficiencies; evaluating laboratories' plans to 
correct deficiencies; and necessary administrative costs. HHS sets the 
fee amounts annually on a calendar year basis. Laboratories are 
inspected biennially; therefore, fees are assessed and payable 
biennially. If additional expenses are incurred to conduct follow up 
visits to verify correction of deficiencies, to impose sanctions, and/or 
for surveyor preparation for and attendance at ALJ hearings, HHS 
assesses an additional fee to include these costs. The additional fee is 
based on the actual resources and time necessary to perform the 
activities.
    (c) Classification of laboratories that require inspection for 
purpose of determining amount of fee. (1) There are ten classifications 
(schedules) of laboratories for the purpose of determining the fee 
amount a laboratory is assessed. Each laboratory is placed into one of 
the ten following schedules based on the laboratory's scope and volume 
of testing (excluding tests performed for quality control, quality 
assurance, and proficiency testing purposes).
    (i) (A) Schedule A Low Volume. The laboratory performs not more than 
2,000 laboratory tests annually.
    (B) Schedule A. The laboratory performs tests in no more than 3 
specialties of service with a total annual volume of more than 2,000 but 
not more than 10,000 laboratory tests.
    (ii) Schedule B. The laboratory performs tests in at least 4 
specialties of service with a total annual volume of not more than 
10,000 laboratory tests.
    (iii) Schedule C. The laboratory performs tests in no more 3 
specialties of service with a total annual volume of more than 10,000 
but not more than 25,000 laboratory tests.
    (iv) Schedule D. The laboratory performs tests in at least 4 
specialties with a total annual volume of more than 10,000 but not more 
than 25,000 laboratory tests.
    (v) Schedule E. The laboratory performs more than 25,000 but not 
more than 50,000 laboratory tests annually.
    (vi) Schedule F. The laboratory performs more than 50,000 but not 
more than 75,000 laboratory tests annually.
    (vii) Schedule G. The laboratory performs more than 75,000 but not 
more than 100,000 laboratory tests annually.
    (viii) Schedule H. The laboratory performs more than 100,000 but not 
more than 500,000 laboratory tests annually.
    (ix) Schedule I. The laboratory performs more than 500,000 but not 
more than 1,000,000 laboratory tests annually.

[[Page 665]]

    (x) Schedule J. The laboratory performs more than 1,000,000 
laboratory tests annually.
    (2) For purposes of determining a laboratory's classification under 
this section, a test is a procedure or examination for a single analyte. 
(Tests performed for quality control, quality assurance, and proficiency 
testing are excluded from the laboratory's total annual volume). Each 
profile (that is, group of tests) is counted as the number of separate 
procedures or examinations; for example, a chemistry profile consisting 
of 18 tests is counted as 18 separate procedures or tests.
    (3) For purposes of determining a laboratory's classification under 
this section, the specialties and subspecialties of service for 
inclusion are:
    (i) The specialty of Microbiology, which includes one or more of the 
following subspecialties:
    (A) Bacteriology.
    (B) Mycobacteriology.
    (C) Mycology.
    (D) Parasitology.
    (E) Virology.
    (ii) The specialty of Serology, which includes one or more of the 
following subspecialties:
    (A) Syphilis Serology.
    (B) General immunology
    (iii) The specialty of Chemistry, which includes one or more of the 
following subspecialties:
    (A) Routine chemistry.
    (B) Endocrinology.
    (C) Toxicology.
    (D) Urinalysis.
    (iv) The specialty of Hematology.
    (v) The specialty of Immunohematology, which includes one or more of 
the following subspecialties:
    (A) ABO grouping and Rh typing.
    (B) Unexpected antibody detection.
    (C) Compatibility testing.
    (D) Unexpected antibody identification.
    (vi) The specialty of Pathology, which includes the following 
subspecialties:
    (A) Cytology.
    (B) Histopathology.
    (C) Oral pathology.
    (vii) The specialty of Radiobioassay.
    (viii) The specialty of Histocompatibility.
    (ix) The specialty of Clinical Cytogenetics.
    (d) Additional fees. (1) If after a certificate of compliance is 
issued, a laboratory adds services and requests that its certificate be 
upgraded, the laboratory must pay an additional fee if, in order to 
determine compliance with additional requirements, it is necessary to 
conduct an inspection, evaluate personnel, or monitor proficiency 
testing performance. The additional fee is based on the actual resources 
and time necessary to perform the activities. HHS revokes the 
laboratory's certificate for failure to pay the compliance determination 
fee.
    (2) If it is necessary to conduct a complaint investigation, impose 
sanctions, or conduct a hearing, HHS assesses the laboratory holding a 
certificate of compliance a fee to cover the cost of these activities. 
If a complaint investigation results in a complaint being 
unsubstantiated, or if an HHS adverse action is overturned at the 
conclusion of the administrative appeals process, the government's costs 
of these activities are not imposed upon the laboratory. Costs for these 
activities are based on the actual resources and time necessary to 
perform the activities and are not assessed until after the laboratory 
concedes the existence of deficiencies or an ALJ rules in favor of HHS. 
HHS revokes the laboratory's certificate of compliance for failure to 
pay the assessed costs.

[57 FR 7138, 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr. 24, 
1995; 68 FR 3702, Jan. 24, 2003]



Sec. 493.645  Additional fee(s) applicable to approved State 
laboratory programs and laboratories issued a certificate of
accreditation, certificate of waiver, or certificate for PPM
procedures.
          

    (a) Approved State laboratory programs. State laboratory programs 
approved by HHS are assessed a fee for the following:
    (1) Costs of Federal inspections of laboratories in that State (that 
is, CLIA-exempt laboratories) to verify that standards are being 
enforced in an appropriate manner.
    (2) Costs incurred for investigations of complaints against the 
State's

[[Page 666]]

CLIA-exempt laboratories if the complaint is substantiated.
    (3) Costs of the State's prorata share of general overhead to 
develop and implement CLIA.
    (b) Accredited laboratories. (1) In addition to the certificate fee, 
a laboratory that is issued a certificate of accreditation is also 
assessed a fee to cover the cost of evaluating individual laboratories 
to determine overall whether an accreditation organization's standards 
and inspection policies are equivalent to the Federal program. All 
accredited laboratories share in the cost of these inspections. These 
costs are the same as those that are incurred when inspecting 
nonaccredited laboratories.
    (2) If a laboratory issued a certificate of accreditation has been 
inspected and followup visits are necessary because of identified 
deficiencies, HHS assesses the laboratory a fee to cover the cost of 
these visits. The fee is based on the actual resources and time 
necessary to perform the followup visits. HHS revokes the laboratory's 
certificate of accreditation for failure to pay the assessed fee.
    (c) If, in the case of a laboratory that has been issued a 
certificate of accreditation, certificate of waiver, or certificate for 
PPM procedures, it is necessary to conduct a complaint investigation, 
impose sanctions, or conduct a hearing, HHS assesses that laboratory a 
fee to cover the cost of these activities. Costs are based on the actual 
resources and time necessary to perform the activities and are not 
assessed until after the laboratory concedes the existence of 
deficiencies or an ALJ rules in favor of HHS. HHS revokes the 
laboratory's certificate for failure to pay the assessed costs. If a 
complaint investigation results in a complaint being unsubstantiated, or 
if an HHS adverse action is overturned at the conclusion of the 
administrative appeals process, the costs of these activities are not 
imposed upon the laboratory.

[60 FR 20047, Apr. 24, 1995]



Sec. 493.646  Payment of fees.

    (a) Except for CLIA-exempt laboratories, all laboratories are 
notified in writing by HHS or its designee of the appropriate fee(s) and 
instructions for submitting the fee(s), including the due date for 
payment and where to make payment. The appropriate certificate is not 
issued until the applicable fees have been paid.
    (b) For State-exempt laboratories, HHS estimates the cost of 
conducting validation surveys within the State for a 2-year period. HHS 
or its designee notifies the State by mail of the appropriate fees, 
including the due date for payment and the address of the United States 
Department of Treasury designated commercial bank to which payment must 
be made. In addition, if complaint investigations are conducted in 
laboratories within these States and are substantiated, HHS bills the 
State(s) the costs of the complaint investigations.

[57 FR 7138, 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 
1995]



Sec. 493.649  Methodology for determining fee amount.

    (a) General rule. The amount of the fee in each schedule for 
compliance determination inspections is based on the average hourly rate 
(which includes the costs to perform the required activities and 
necessary administration costs) multiplied by the average number of 
hours required or, if activities are performed by more than one of the 
entities listed in paragraph (b) of this section, the sum of the 
products of the applicable hourly rates multiplied by the average number 
of hours required by the entity to perform the activity. The fee for 
issuance of the registration certificate or certificate of compliance is 
based on the laboratory's scope and volume of testing.
    (b) Determining average hourly rates used in fee schedules. Three 
different entities perform activities related to the issuance or 
reissuance of any certificate. HHS determines the average hourly rates 
for the activities of each of these entities.
    (1) State survey agencies. The following costs are included in 
determining an average hourly rate for the activities performed by State 
survey agencies:
    (i) The costs incurred by the State survey agencies in evaluating 
personnel qualifications and monitoring each laboratory's participation 
in an approved proficiency testing program.

[[Page 667]]

The cost of onsite inspections and monitoring activities is the hourly 
rate derived as a result of an annual budget negotiation process with 
each State. The hourly rate encompasses salary costs (as determined by 
each State's civil service pay scale) and fringe benefit costs to 
support the required number of State inspectors, management and direct 
support staff.
    (ii) Travel costs necessary to comply with each State's 
administrative requirements and other direct costs such as equipment, 
printing, and supplies. These costs are established based on historical 
State requirements.
    (iii) Indirect costs as negotiated by HHS.
    (2) Federal agencies. The hourly rate for activities performed by 
Federal agencies is the most recent average hourly cost to HHS to staff 
and support a full time equivalent employee. Included in this cost are 
salary and fringe benefit costs, necessary administrative costs, such as 
printing, training, postage, express mail, supplies, equipment, computer 
system and building service charges associated with support services 
provided by organizational components such as a computer center, and any 
other oversight activities necessary to support the program.
    (3) HHS contractors. The hourly rate for activities performed by HHS 
contractors is the average hourly rate established for contractor 
assistance based on an independent government cost estimate for the 
required workload. This rate includes the cost of contractor support to 
provide proficiency testing programs to laboratories that do not 
participate in an approved proficiency testing program, provide 
specialized assistance in the evaluation of laboratory performance in an 
approved proficiency testing program, perform assessments of cytology 
testing laboratories, conduct special studies, bill and collect fees, 
issue certificates, establish accounting, monitoring and reporting 
systems, and assist with necessary surveyor training.
    (c) Determining number of hours. The average number of hours used to 
determine the overall fee in each schedule is HHS's estimate, based on 
historical experience, of the average time needed by each entity to 
perform the activities for which it is responsible.

[57 FR 7138, 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 
1995]

Subpart G [Reserved]



    Subpart H_Participation in Proficiency Testing for Laboratories 
                      Performing Nonwaived Testing

    Source: 57 FR 7146, Feb. 28, 1992, unless otherwise noted.



Sec. 493.801  Condition: Enrollment and testing of samples.

    Each laboratory must enroll in a proficiency testing (PT) program 
that meets the criteria in subpart I of this part and is approved by 
HHS. The laboratory must enroll in an approved program or programs for 
each of the specialties and subspecialties for which it seeks 
certification. The laboratory must test the samples in the same manner 
as patients' specimens. For laboratories subject to 42 CFR part 493 
published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the 
rules of this subpart are effective on September 1, 1992. For all other 
laboratories, the rules of this subpart are effective January 1, 1994.
    (a) Standard; Enrollment. The laboratory must--
    (1) Notify HHS of the approved program or programs in which it 
chooses to participate to meet proficiency testing requirements of this 
subpart.
    (2)(i) Designate the program(s) to be used for each specialty, 
subspecialty, and analyte or test to determine compliance with this 
subpart if the laboratory participates in more than one proficiency 
testing program approved by CMS; and
    (ii) For those tests performed by the laboratory that are not 
included in subpart I of this part, a laboratory must establish and 
maintain the accuracy of its testing procedures, in accordance with 
Sec. 493.1236(c)(1).
    (3) For each specialty, subspecialty and analyte or test, 
participate in one approved proficiency testing program or programs, for 
one year before designating a different program and must

[[Page 668]]

notify CMS before any change in designation; and
    (4) Authorize the proficiency testing program to release to HHS all 
data required to--
    (i) Determine the laboratory's compliance with this subpart; and
    (ii) Make PT results available to the public as required in section 
353(f)(3)(F) of the Public Health Service Act.
    (b) Standard: Testing of proficiency testing samples. The laboratory 
must examine or test, as applicable, the proficiency testing samples it 
receives from the proficiency testing program in the same manner as it 
tests patient specimens. This testing must be conducted in conformance 
with paragraph (b)(4) of this section. If the laboratory's patient 
specimen testing procedures would normally require reflex, distributive, 
or confirmatory testing at another laboratory, the laboratory should 
test the proficiency testing sample as it would a patient specimen up 
until the point it would refer a patient specimen to a second laboratory 
for any form of further testing.
    (1) The samples must be examined or tested with the laboratory's 
regular patient workload by personnel who routinely perform the testing 
in the laboratory, using the laboratory's routine methods. The 
individual testing or examining the samples and the laboratory director 
must attest to the routine integration of the samples into the patient 
workload using the laboratory's routine methods.
    (2) The laboratory must test samples the same number of times that 
it routinely tests patient samples.
    (3) Laboratories that perform tests on proficiency testing samples 
must not engage in any inter-laboratory communications pertaining to the 
results of proficiency testing sample(s) until after the date by which 
the laboratory must report proficiency testing results to the program 
for the testing event in which the samples were sent. Laboratories with 
multiple testing sites or separate locations must not participate in any 
communications or discussions across sites/locations concerning 
proficiency testing sample results until after the date by which the 
laboratory must report proficiency testing results to the program.
    (4) The laboratory must not send proficiency testing samples or 
portions of proficiency testing samples to another laboratory for any 
analysis for which it is certified to perform in its own laboratory. Any 
laboratory that CMS determines intentionally referred a proficiency 
testing sample to another laboratory for analysis may have its 
certification revoked for at least 1 year. If CMS determines that a 
proficiency testing sample was referred to another laboratory for 
analysis, but the requested testing was limited to reflex, distributive, 
or confirmatory testing that, if the sample were a patient specimen, 
would have been in full conformance with written, legally accurate and 
adequate standard operating procedures for the laboratory's testing of 
patient specimens, and if the proficiency testing referral is not a 
repeat proficiency testing referral, CMS will consider the referral to 
be improper and subject to alternative sanctions in accordance with 
Sec. 493.1804(c), but not intentional. Any laboratory that receives a 
proficiency testing sample from another laboratory for testing must 
notify CMS of the receipt of that sample regardless of whether the 
referral was made for reflex or confirmatory testing, or any other 
reason.
    (5) The laboratory must document the handling, preparation, 
processing, examination, and each step in the testing and reporting of 
results for all proficiency testing samples. The laboratory must 
maintain a copy of all records, including a copy of the proficiency 
testing program report forms used by the laboratory to record 
proficiency testing results including the attestation statement provided 
by the PT program, signed by the analyst and the laboratory director, 
documenting that proficiency testing samples were tested in the same 
manner as patient specimens, for a minimum of two years from the date of 
the proficiency testing event.
    (6) PT is required for only the test system, assay, or examination 
used as the primary method for patient testing during the PT event.

[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003; 79 FR 27157, May 12, 2014]

[[Page 669]]



Sec. 493.803  Condition: Successful participation.

    (a) Each laboratory performing nonwaived testing must successfully 
participate in a proficiency testing program approved by CMS, if 
applicable, as described in subpart I of this part for each specialty, 
subspecialty, and analyte or test in which the laboratory is certified 
under CLIA.
    (b) Except as specified in paragraph (c) of this section, if a 
laboratory fails to participate successfully in proficiency testing for 
a given specialty, subspecialty, analyte or test, as defined in this 
section, or fails to take remedial action when an individual fails 
gynecologic cytology, CMS imposes sanctions, as specified in subpart R 
of this part.
    (c) If a laboratory fails to perform successfully in a CMS-approved 
proficiency testing program, for the initial unsuccessful performance, 
CMS may direct the laboratory to undertake training of its personnel or 
to obtain technical assistance, or both, rather than imposing 
alternative or principle sanctions except when one or more of the 
following conditions exists:
    (1) There is immediate jeopardy to patient health and safety.
    (2) The laboratory fails to provide CMS or a CMS agent with 
satisfactory evidence that it has taken steps to correct the problem 
identified by the unsuccessful proficiency testing performance.
    (3) The laboratory has a poor compliance history.

[57 FR 7146, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 1995; 63 
FR 26737, May 14, 1998; 68 FR 3702, Jan. 24, 2003]



Sec. 493.807  Condition: Reinstatement of laboratories performing
nonwaived testing.

    (a) If a laboratory's certificate is suspended or limited or its 
Medicare or Medicaid approval is cancelled or its Medicare or Medicaid 
payments are suspended because it fails to participate successfully in 
proficiency testing for one or more specialties, subspecialties, analyte 
or test, or voluntarily withdraws its certification under CLIA for the 
failed specialty, subspecialty, or analyte, the laboratory must then 
demonstrate sustained satisfactory performance on two consecutive 
proficiency testing events, one of which may be on site, before CMS will 
consider it for reinstatement for certification and Medicare or Medicaid 
approval in that specialty, subspecialty, analyte or test.
    (b) The cancellation period for Medicare and Medicaid approval or 
period for suspension of Medicare or Medicaid payments or suspension or 
limitation of certification under CLIA for the failed specialty, 
subspecialty, or analyte or test is for a period of not less than six 
months from the date of cancellation, limitation or suspension of the 
CLIA certificate.

[58 FR 5228, Jan. 19, 1993, as amended at 60 FR 20048, Apr. 24, 1995]

   Proficiency Testing by Specialty and Subspecialty for Laboratories 
  Performing Tests of Moderate Complexity (Including the Subcategory), 
           High Complexity, or Any Combination of These Tests



Sec. 493.821  Condition: Microbiology.

    The specialty of microbiology includes, for purposes of proficiency 
testing, the subspecialties of bacteriology, mycobacteriology, mycology, 
parasitology and virology.



Sec. 493.823  Standard; Bacteriology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.

[[Page 670]]

    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) Remedial action must be taken and documented, and the 
documentation must be maintained by the laboratory for two years from 
the date of participation in the proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.825  Standard; Mycobacteriology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) Remedial action must be taken and documented, and the 
documentation must be maintained by the laboratory for two years from 
the date of participation in the proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.827  Standard; Mycology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.

[[Page 671]]

    (2) Remedial action must be taken and documented, and the 
documentation must be maintained by the laboratory for two years from 
the date of participation in the proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.829  Standard; Parasitology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) Remedial action must be taken and documented, and the 
documentation must be maintained by the laboratory for two years from 
the date of participation in the proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.831  Standard; Virology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) For any unsatisfactory testing events, remedial action must be 
taken and documented, and the documentation must be maintained by the 
laboratory for two years from the date of participation in the 
proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.833  Condition: Diagnostic immunology.

    The specialty of diagnostic immunology includes for purposes of 
proficiency testing the subspecialties of

[[Page 672]]

syphilis serology and general immunology.



Sec. 493.835  Standard; Syphilis serology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) For any unacceptable testing event score, remedial action must 
be taken and documented, and the documentation must be maintained by the 
laboratory for two years from the date of participation in the 
proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.837  Standard; General immunology.

    (a) Failure to attain a score of at least 80 percent of acceptable 
responses for each analyte in each testing event is unsatisfactory 
analyte performance for the testing event.
    (b) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (c) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (d) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (e)(1) For any unsatisfactory analyte or test performance or testing 
event for reasons other than a failure to participate, the laboratory 
must undertake appropriate training and employ the technical assistance 
necessary to correct problems associated with a proficiency testing 
failure.
    (2) For any unacceptable analyte or testing event score, remedial 
action must be taken and documented, and the documentation must be 
maintained by the laboratory for two years from the date of 
participation in the proficiency testing event.
    (f) Failure to achieve satisfactory performance for the same analyte 
or test in two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.
    (g) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.

[[Page 673]]



Sec. 493.839  Condition: Chemistry.

    The specialty of chemistry includes for the purposes of proficiency 
testing the subspecialties of routine chemistry, endocrinology, and 
toxicology.



Sec. 493.841  Standard; Routine chemistry.

    (a) Failure to attain a score of at least 80 percent of acceptable 
responses for each analyte in each testing event is unsatisfactory 
analyte performance for the testing event.
    (b) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (c) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (d) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (e)(1) For any unsatisfactory analyte or test performance or testing 
event for reasons other than a failure to participate, the laboratory 
must undertake appropriate training and employ the technical assistance 
necessary to correct problems associated with a proficiency testing 
failure.
    (2) For any unacceptable analyte or testing event score, remedial 
action must be taken and documented, and the documentation must be 
maintained by the laboratory for two years from the date of 
participation in the proficiency testing event.
    (f) Failure to achieve satisfactory performance for the same analyte 
or test in two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.
    (g) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.843  Standard; Endocrinology.

    (a) Failure to attain a score of at least 80 percent of acceptable 
responses for each analyte in each testing event is unsatisfactory 
analyte performance for the testing event.
    (b) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (c) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (d) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (e)(1) For any unsatisfactory analyte or test performance or testing 
event for reasons other than a failure to participate, the laboratory 
must undertake appropriate training and employ the technical assistance 
necessary to correct problems associated with a proficiency testing 
failure.
    (2) For any unacceptable analyte or testing event score, remedial 
action must be taken and documented, and the documentation must be 
maintained by the laboratory for two years from

[[Page 674]]

the date of participation in the proficiency testing event.
    (f) Failure to achieve satisfactory performance for the same analyte 
or test in two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.
    (g) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.845  Standard; Toxicology.

    (a) Failure to attain a score of at least 80 percent of acceptable 
responses for each analyte in each testing event is unsatisfactory 
analyte performance for the testing event.
    (b) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (c) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (d) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (e)(1) For any unsatisfactory analyte or test performance or testing 
event for reasons other than a failure to participate, the laboratory 
must undertake appropriate training and employ the technical assistance 
necessary to correct problems associated with a proficiency testing 
failure.
    (2) For any unacceptable analyte or testing event score, remedial 
action must be taken and documented, and the documentation must be 
maintained by the laboratory for two years from the date of 
participation in the proficiency testing event.
    (f) Failure to achieve satisfactory performance for the same analyte 
or test in two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.
    (g) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.849  Condition: Hematology.

    The specialty of hematology, for the purpose of proficiency testing, 
is not subdivided into subspecialties of testing.



Sec. 493.851  Standard; Hematology.

    (a) Failure to attain a score of at least 80 percent of acceptable 
responses for each analyte in each testing event is unsatisfactory 
analyte performance for the testing event.
    (b) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (c) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (d) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.

[[Page 675]]

    (e)(1) For any unsatisfactory analyte or test performance or testing 
event for reasons other than a failure to participate, the laboratory 
must undertake appropriate training and employ the technical assistance 
necessary to correct problems associated with a proficiency testing 
failure.
    (2) For any unacceptable analyte or testing event score, remedial 
action must be taken and documented, and the documentation must be 
maintained by the laboratory for two years from the date of 
participation in the proficiency testing event.
    (f) Failure to achieve satisfactory performance for the same analyte 
in two consecutive events or two out of three consecutive testing events 
is unsuccessful performance.
    (g) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.



Sec. 493.853  Condition: Pathology.

    The specialty of pathology includes, for purposes of proficiency 
testing, the subspecialty of cytology limited to gynecologic 
examinations.



Sec. 493.855  Standard; Cytology: gynecologic examinations.

    To participate successfully in a cytology proficiency testing 
program for gynecologic examinations (Pap smears), the laboratory must 
meet the requirements of paragraphs (a) through (c) of this section.
    (a) The laboratory must ensure that each individual engaged in the 
examination of gynecologic preparations is enrolled in a proficiency 
testing program approved by CMS by January 1, 1995, if available in the 
State in which he or she is employed. The laboratory must ensure that 
each individual is tested at least once per year and obtains a passing 
score. To ensure this annual testing of individuals, an announced or 
unannounced testing event will be conducted on-site in each laboratory 
at least once each year. Laboratories will be notified of the time of 
each announced on-site testing event at least 30 days prior to each 
event. Additional testing events will be conducted as necessary in each 
State or region for the purpose of testing individuals who miss the on-
site testing event and for retesting individuals as described in 
paragraph (b) of this section.
    (b) The laboratory must ensure that each individual participates in 
an annual testing event that involves the examination of a 10-slide test 
set as described in Sec. 493.945. Individuals who fail this testing 
event are retested with another 10-slide test set as described in 
paragraphs (b)(1) and (b)(2) of this section. Individuals who fail this 
second test are subsequently retested with a 20-slide test set as 
described in paragraphs (b)(2) and (b)(3) of this section. Individuals 
are given not more than 2 hours to complete a 10-slide test and not more 
than 4 hours to complete a 20-slide test. Unexcused failure to appear by 
an individual for a retest will result in test failure with resulting 
remediation and limitations on slide examinations as specified in 
(b)(1), (b)(2), and (b)(3) of this section.
    (1) An individual is determined to have failed the annual testing 
event if he or she scores less than 90 percent on a 10-slide test set. 
For an individual who fails an annual proficiency testing event, the 
laboratory must schedule a retesting event which must take place not 
more than 45 days after receipt of the notification of failure.
    (2) An individual is determined to have failed the second testing 
event if he or she scores less than 90 percent on a 10-slide test set. 
For an individual who fails a second testing event, the laboratory must 
provide him or her with documented, remedial training and education in 
the area of failure, and must assure that all gynecologic slides 
evaluated subsequent to the notice of failure are reexamined until the 
individual is again retested with a 20-slide test set and scores at 
least 90 percent. Reexamination of slides must be documented.
    (3) An individual is determined to have failed the third testing 
event if he or she scores less than 90 percent on a 20-slide test set. 
An individual who fails the third testing event must cease examining 
gynecologic slide preparations immediately upon notification of

[[Page 676]]

test failure and may not resume examining gynecologic slides until the 
laboratory assures that the individual obtains at least 35 hours of 
documented, formally structured, continuing education in diagnostic 
cytopathology that focuses on the examination of gynecologic 
preparations, and until he or she is retested with a 20-slide test set 
and scores at least 90 percent.
    (c) If a laboratory fails to ensure that individuals are tested or 
those who fail a testing event are retested, or fails to take required 
remedial actions as described in paragraphs (b)(1), (b)(2) or (b)(3) of 
this section, CMS will initiate intermediate sanctions or limit the 
laboratory's certificate to exclude gynecologic cytology testing under 
CLIA, and, if applicable, suspend the laboratory's Medicare and Medicaid 
payments for gynecologic cytology testing in accordance with subpart R 
of this part.

[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 59 
FR 62609, Dec. 6, 1994]



Sec. 493.857  Condition: Immunohematology.

    The specialty of immunohematology includes four subspecialties for 
the purposes of proficiency testing: ABO group and D (Rho) typing; 
unexpected antibody detection; compatibility testing; and antibody 
identification.



Sec. 493.859  Standard; ABO group and D (Rho) typing.

    (a) Failure to attain a score of at least 100 percent of acceptable 
responses for each analyte or test in each testing event is 
unsatisfactory analyte performance for the testing event.
    (b) Failure to attain an overall testing event score of at least 100 
percent is unsatisfactory performance.
    (c) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (d) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (e)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) For any unacceptable analyte or unsatisfactory testing event 
score, remedial action must be taken and documented, and the 
documentation must be maintained by the laboratory for two years from 
the date of participation in the proficiency testing event.
    (f) Failure to achieve satisfactory performance for the same analyte 
in two consecutive testing events or two out of three consecutive 
testing events is unsuccessful performance.
    (g) Failure to achieve an overall testing event score of 
satisfactory for two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.



Sec. 493.861  Standard; Unexpected antibody detection.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame

[[Page 677]]

for submitting proficiency testing results of the suspension of patient 
testing and the circumstances associated with failure to perform tests 
on proficiency testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) For any unsatisfactory testing event score, remedial action must 
be taken and documented, and the documentation must be maintained by the 
laboratory for two years from the date of participation in the 
proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory for two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.



Sec. 493.863  Standard; Compatibility testing.

    (a) Failure to attain an overall testing event score of at least 100 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) For any unsatisfactory testing event score, remedial action must 
be taken and documented, and the documentation must be maintained by the 
laboratory for two years from the date of participation in the 
proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory for two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.



Sec. 493.865  Standard; Antibody identification.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory

[[Page 678]]

performance and results in a score of 0 for the testing event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) For any unsatisfactory testing event score, remedial action must 
be taken and documented, and the documentation must be maintained by the 
laboratory for two years from the date of participation in the 
proficiency testing event.
    (e) Failure to identify the same antibody in two consecutive or two 
out of three consecutive testing events is unsuccessful performance.
    (f) Failure to achieve an overall testing event score of 
satisfactory for two consecutive testing events or two out of three 
consecutive testing events is unsuccessful performance.



      Subpart I_Proficiency Testing Programs for Nonwaived Testing

    Source: 57 FR 7151, Feb. 28, 1992, unless otherwise noted.



Sec. 493.901  Approval of proficiency testing programs.

    In order for a proficiency testing program to receive HHS approval, 
the program must be offered by a private nonprofit organization or a 
Federal or State agency, or entity acting as a designated agent for the 
State. An organization, Federal, or State program seeking approval or 
reapproval for its program for the next calendar year must submit an 
application providing the required information by July 1 of the current 
year. The organization, Federal, or State program must provide technical 
assistance to laboratories seeking to qualify under the program, and 
must, for each specialty, subspecialty, and analyte or test for which it 
provides testing--
    (a) Assure the quality of test samples, appropriately evaluate and 
score the testing results, and identify performance problems in a timely 
manner;
    (b) Demonstrate to HHS that it has--
    (1) The technical ability required to--
    (i) Prepare or purchase samples from manufacturers who prepare the 
samples in conformance with the appropriate good manufacturing practices 
required in 21 CFR parts 606, 640, and 820; and
    (ii) Distribute the samples, using rigorous quality control to 
assure that samples mimic actual patient specimens when possible and 
that samples are homogeneous, except for specific subspecialties such as 
cytology, and will be stable within the time frame for analysis by 
proficiency testing participants;
    (2) A scientifically defensible process for determining the correct 
result for each challenge offered by the program;
    (3) A program of sufficient annual challenge and with the frequency 
specified in Sec. Sec. 493.909 through 493.959 to establish that a 
laboratory has met minimum performance requirements;
    (4) The resources needed to provide Statewide or nationwide reports 
to regulatory agencies on individual's performance for gynecologic 
cytology and on individual laboratory performance on testing events, 
cumulative reports and scores for each laboratory or individual, and 
reports of specific laboratory failures using grading criteria 
acceptable to HHS. These reports must be provided to HHS on a timely 
basis when requested;
    (5) Provisions to include on each proficiency testing program report 
form used by the laboratory to record testing event results, an 
attestation statement that proficiency testing samples were tested in 
the same manner as patient specimens with a signature block to be 
completed by the individual performing the test as well as by the 
laboratory director;
    (6) A mechanism for notifying participants of the PT shipping 
schedule and for participants to notify the proficiency testing program 
within three days of the expected date of receipt of the shipment that 
samples have not arrived or are unacceptable for testing. The program 
must have provisions for replacement of samples that are lost in transit 
or are received in a condition that is unacceptable for testing; and
    (7) A process to resolve technical, administrative, and scientific 
problems about program operations;

[[Page 679]]

    (c) Meet the specific criteria for proficiency testing programs 
listed by specialty, subspecialty, and analyte or test contained in 
Sec. Sec. 493.901 through 493.959 for initial approval and thereafter 
provide HHS, on an annual basis, with the information necessary to 
assure that the proficiency testing program meets the criteria required 
for approval; and
    (d) Comply with all applicable packaging, shipment, and notification 
requirements of 42 CFR part 72.

[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]



Sec. 493.903  Administrative responsibilities.

    The proficiency testing program must--
    (a)(1) Provide HHS or its designees and participating laboratories 
with an electronic or a hard copy, or both, of reports of proficiency 
testing results and all scores for each laboratory's performance in a 
format as required by and approved by CMS for each CLIA-certified 
specialty, subspecialty, and analyte or test within 60 days after the 
date by which the laboratory must report proficiency testing results to 
the proficiency testing program.
    (2) Provide HHS with reports of PT results and scores of individual 
performance in cytology and provide copies of reports to participating 
individuals, and to all laboratories that employ the individuals, within 
15 working days of the testing event;
    (b) Furnish to HHS cumulative reports on an individual laboratory's 
performance and aggregate data on CLIA-certified laboratories for the 
purpose of establishing a system to make the proficiency testing 
program's results available, on a reasonable basis, upon request of any 
person, and include such explanatory information as may be appropriate 
to assist in the interpretation of the proficiency testing program's 
results;
    (c) Provide HHS with additional information and data upon request 
and submit such information necessary for HHS to conduct an annual 
evaluation to determine whether the proficiency testing program 
continues to meet the requirements of Sec. Sec. 493.901 through 
493.959;
    (d) Maintain records of laboratories' performance for a period of 
five years or such time as may be necessary for any legal proceedings; 
and
    (e) Provide HHS with an annual report and, if needed, an interim 
report which identifies any previously unrecognized sources of 
variability in kits, instruments, methods, or PT samples, which 
adversely affect the programs' ability to evaluate laboratory 
performance.

[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]



Sec. 493.905  Nonapproved proficiency testing programs.

    If a proficiency testing program is determined by HHS to fail to 
meet any criteria contained in Sec. Sec. 493.901 through 493.959 for 
approval of the proficiency testing program, CMS will notify the program 
and the program must notify all laboratories enrolled of the nonapproval 
and the reasons for nonapproval within 30 days of the notification.

       Proficiency Testing Programs by Specialty and Subspecialty



Sec. 493.909  Microbiology.

    The subspecialties under the specialty of microbiology for which a 
program may offer proficiency testing are bacteriology, 
mycobacteriology, mycology, parasitology and virology. Specific criteria 
for these subspecialties are found at Sec. Sec. 493.911 through 
493.919.



Sec. 493.911  Bacteriology.

    (a) Types of services offered by laboratories. In bacteriology, for 
proficiency testing purposes, there are five types of laboratories:
    (1) Those that interpret Gram stains or perform primary inoculation, 
or both; and refer cultures to another laboratory appropriately 
certified for the subspecialty of bacteriology for identification;
    (2) Those that use direct antigen techniques to detect an organism 
and may also interpret Gram stains or perform primary inoculation, or 
perform any combination of these;
    (3) Those that, in addition to interpreting Gram stains, performing 
primary inoculations, and using direct

[[Page 680]]

antigen tests, also isolate and identify aerobic bacteria from throat, 
urine, cervical, or urethral discharge specimens to the genus level and 
may also perform antimicrobial susceptibility tests on selected isolated 
microorganisms;
    (4) Those that perform the services in paragraph (a)(3) of this 
section and also isolate and identify aerobic bacteria from any source 
to the species level and may also perform antimicrobial susceptibility 
tests; and
    (5) Those that perform the services in paragraph (a)(4) of this 
section and also isolate and identify anaerobic bacteria from any 
source.
    (b) Program content and frequency of challenge. To be approved for 
proficiency testing for bacteriology, the annual program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The samples 
may be provided to the laboratory through mailed shipments or, at HHS' 
option, may be provided to HHS or its designee for on-site testing. For 
the types of laboratories specified in paragraph (a) of this section, an 
annual program must include samples that contain organisms that are 
representative of the six major groups of bacteria: anaerobes, 
Enterobacteriaceae, gram-positive bacilli, gram-positive cocci, gram-
negative cocci, and miscellaneous gram-negative bacteria, as 
appropriate. The specific organisms included in the samples may vary 
from year to year. The annual program must include samples for bacterial 
antigen detection, bacterial isolation and identification, Gram stain, 
and antimicrobial susceptibility testing.
    (1) An approved program must furnish HHS with a description of 
samples that it plans to include in its annual program no later than six 
months before each calendar year. At least 50 percent of the samples 
must be mixtures of the principal organism and appropriate normal flora. 
The program must include other important emerging pathogens (as 
determined by HHS) and either organisms commonly occurring in patient 
specimens or opportunistic pathogens. The program must include the 
following two types of samples; each type of sample must meet the 50 
percent mixed culture criterion:
    (i) Samples that require laboratories to report only organisms that 
the testing laboratory considers to be a principal pathogen that is 
clearly responsible for a described illness (excluding immuno-
compromised patients). The program determines the reportable isolates, 
including antimicrobial susceptibility for any designated isolate; and
    (ii) Samples that require laboratories to report all organisms 
present. Samples must contain multiple organisms frequently found in 
specimens such as urine, blood, abscesses, and aspirates where multiple 
isolates are clearly significant or where specimens are derived from 
immuno-compromised patients. The program determines the reportable 
isolates.
    (2) An approved program may vary over time. For example, the types 
of organisms that might be included in an approved program over time 
are--

Anaerobes:
    Bacteroides fragilis group
    Clostridium perfringens
    Peptostreptococcus anaerobius
    Enterobacteriaceae
    Citrobacter freundii
    Enterobacter aerogenes
    Escherichia coli
    Klebsiella pneumoniae
    Proteus mirabilis
    Salmonella typhimurium
    Serratia marcescens
    Shigella sonnei
    Yersinia enterocolitica
Gram-positive bacilli:
    Listeria monocytogenes
    Corynebacterium species CDC Group JK
Gram-positive cocci:
    Staphylococcus aureus
    Streptococcus Group A
    Streptococcus Group B
    Streptococcus Group D (S. bovis and enterococcus)
    Streptococcus pneumoniae
Gram-negative cocci:
    Branhamella catarrhalis
    Neisseria gonorrhoeae
    Neisseria meningitidis
Miscellaneous Gram-negative bacteria:
    Campylobacter jejuni
    Haemophilis influenza, Type B
    Pseudomonas aeruginosa

    (3) For antimicrobial susceptibility testing, the program must 
provide at least one sample per testing event that includes gram-
positive or gram-negative strains that have a predetermined

[[Page 681]]

pattern of sensitivity or resistance to the common antimicrobial agents.
    (c) Evaluation of a laboratory's performance. HHS approves only 
those programs that assess the accuracy of a laboratory's responses in 
accordance with paragraphs (c) (1) through (7) of this section.
    (1) The program determines staining characteristics to be 
interpreted by Gram stain. The program determines the reportable 
bacteria to be detected by direct antigen techniques or isolation. To 
determine the accuracy of a laboratory's response for Gram stain 
interpretation, direct antigen detection, identification, or 
antimicrobial susceptibility testing, the program must compare the 
laboratory's response for each sample with the response which reflects 
agreement of either 80 percent of ten or more referee laboratories or 80 
percent or more of all participating laboratories.
    (2) To evaluate a laboratory's response for a particular sample, the 
program must determine a laboratory's type of service in accordance with 
paragraph (a) of this section. A laboratory must isolate and identify 
the organisms to the same extent it performs these procedures on patient 
specimens. A laboratory's performance will be evaluated on the basis of 
its final answer, for example, a laboratory specified in paragraph 
(a)(3) of this section will be evaluated on the basis of the average of 
its scores for paragraphs (c)(3) through (c)(6) as determined in 
paragraph (c)(7) of this section.
    (3) Since laboratories may incorrectly report the presence of 
organisms in addition to the correctly identified principal organism(s), 
the grading system must provide a means of deducting credit for 
additional erroneous organisms that are reported. Therefore, the total 
number of correct responses for organism isolation and identification 
submitted by the laboratory divided by the number of organisms present 
plus the number of incorrect organisms reported by the laboratory must 
be multiplied by 100 to establish a score for each sample in each 
testing event. For example, if a sample contained one principal organism 
and the laboratory reported it correctly but reported the presence of an 
additional organism, which was not considered reportable, the sample 
grade would be 1/(1 + 1) x 100 = 50 percent.
    (4) For antimicrobial susceptibility testing, a laboratory must 
indicate which drugs are routinely included in its test panel when 
testing patient samples. A laboratory's performance will be evaluated 
for only those antibiotics for which service is offered. A correct 
response for each antibiotic will be determined as described in Sec. 
493.911(c) (1) using criteria such as the guidelines established by the 
National Committee for Clinical Laboratory Standards. Grading is based 
on the number of correct susceptibility responses reported by the 
laboratory divided by the actual number of correct susceptibility 
responses determined by the program, multiplied by 100. For example, if 
a laboratory offers susceptibility testing for Enterobacteriaceae using 
amikacin, cephalothin, and tobramycin, and the organism in the 
proficiency testing sample is an Enterobacteriaceae, and the laboratory 
reports correct responses for two of three antimicrobial agents, the 
laboratory's grade would be 2/3 x 100 = 67 percent.
    (5) The performance criterion for qualitative antigen tests is the 
presence or absence of the bacterial antigen. The score for antigen 
tests is the number of correct responses divided by the number of 
samples to be tested for the antigen, multiplied by 100.
    (6) The performance criteria for Gram stain is staining reaction, 
i.e., gram positive or gram negative. The score for Gram stain is the 
number of correct responses divided by the number of challenges to be 
tested, multiplied by 100.
    (7) The score for a testing event in bacteriology is the average of 
the scores determined under paragraphs (c)(3) through (c)(6) of this 
section kbased on the type of service offered by the laboratory.

[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.913  Mycobacteriology.

    (a) Types of services offered by laboratories. In mycobacteriology, 
there are

[[Page 682]]

five types of laboratories for proficiency testing purposes:
    (1) Those that interpret acid-fast stains and refer specimen to 
another laboratory appropriately certified in the subspecialty of 
mycobacteriology;
    (2) Those that interpret acid-fast stains, perform primary 
inoculation, and refer cultures to another laboratory appropriately 
certified in the subspecialty of mycobacteriology for identification;
    (3) Those that interpret acid-fast stains, isolate and perform 
identification and/or antimycobacterial susceptibility of Mycobacterium 
tuberculosis, but refer other mycobacteria species to another laboratory 
appropriately certified in the subspecialty of mycobacteriology for 
identification and/or susceptibility tests;
    (4) Those that interpret acid-fast stains, isolate and identify all 
mycobacteria to the extent required for correct clinical diagnosis, but 
refer antimycobacterial susceptibility tests to another laboratory 
appropriately certified in the subspecialty of mycobacteriology; and
    (5) Those that interpret acid-fast stains, isolate and identify all 
mycobacteria to the extent required for correct clinical diagnosis, and 
perform antimycobacterial susceptibility tests on the organisms 
isolated.
    (b) Program content and frequency of challenge. To be approved for 
proficiency testing for mycobacteriology, the annual program must 
provide a minimum of five samples per testing event. There must be at 
least two testing events per year. The samples may be provided through 
mailed shipments or, at HHS' option, provided to HHS or its designee for 
on-site testing events. For types of laboratories specified in 
paragraphs (a)(1) and (a) (3) through (5) of this section, an annual 
program must include samples that contain species that are 
representative of the 5 major groups (complexes) of mycobacteria 
encountered in human specimens. The specific mycobacteria included in 
the samples may vary from year to year.
    (1) An approved program must furnish HHS and its agents with a 
description of samples that it plans to include in its annual program no 
later than six months before each calendar year. At least 50 percent of 
the samples must be mixtures of the principal mycobacteria and 
appropriate normal flora. The program must include mycobacteria commonly 
occurring in patient specimens and other important emerging mycobacteria 
(as determined by HHS). The program determines the reportable isolates 
and correct responses for antimycobacterial susceptibility for any 
designated isolate.
    (2) An approved program may vary over time. For example, the types 
of mycobacteria that might be included in an approved program over time 
are--

TB
    Mycobacterium tuberculosis
    Mycobacterium bovis
Group I
    Mycobacterium kansasii
Group II
    Mycobacterium szulgai
Group III
    Mycobacterium avium-intracellulare
    Mycobacterium terrae
Group IV
    Mycobacterium fortuitum

    (3) For antimycobacterial susceptibility testing, the program must 
provide at least one sample per testing event that includes 
mycobacterium tuberculosis that has a predetermined pattern of 
sensitivity or resistance to the common antimycobacterial agents.
    (4) For laboratories specified in paragraphs (a)(1) and (a)(2), the 
program must provide at least five samples per testing event that 
includes challenges that are acid-fast and challenges which do not 
contain acid-fast organisms.
    (c) Evaluation of a laboratory's performance. HHS approves only 
those programs that assess the accuracy of a laboratory's response in 
accordance with paragraphs (c)(1) through (6) of this section.
    (1) The program determines the reportable mycobacteria to be 
detected by acid-fast stain, for isolation and identification, and for 
antimycobacterial susceptibility. To determine the accuracy of a 
laboratory's response, the program must compare the laboratory's 
response for each sample with the response that reflects agreement of 
either 80 percent of ten or more referee laboratories or 80 percent or 
more of all participating laboratories.

[[Page 683]]

    (2) To evaluate a laboratory's response for a particular sample, the 
program must determine a laboratory's type of service in accordance with 
paragraph (a) of this section. A laboratory must interpret acid-fast 
stains and isolate and identify the organisms to the same extent it 
performs these procedures on patient specimens. A laboratory's 
performance will be evaluated on the basis of the average of its scores 
as determined in paragraph (c)(6) of this section.
    (3) Since laboratories may incorrectly report the presence of 
organisms in addition to the correctly identified principal organism(s), 
the grading system must provide a means of deducting credit for 
additional erroneous organisms reported. Therefore, the total number of 
correct responses submitted by the laboratory divided by the number of 
organisms present plus the number of incorrect organisms reported by the 
laboratory must be multiplied by 100 to establish a score for each 
sample in each testing event. For example, if a sample contained one 
principal organism and the laboratory reported it correctly but reported 
the presence of an additional organism, which was not present, the 
sample grade would be

1 / (1 + 1) x 100 = 50 percent
    (4) For antimycobacterial susceptibility testing, a laboratory must 
indicate which drugs are routinely included in its test panel when 
testing patient samples. A laboratory's performance will be evaluated 
for only those antibiotics for which susceptibility testing is routinely 
performed on patient specimens. A correct response for each antibiotic 
will be determined as described in Sec. 493.913(c)(1). Grading is based 
on the number of correct susceptibility responses reported by the 
laboratory divided by the actual number of correct susceptibility 
responses as determined by the program, multiplied by 100. For example, 
if a laboratory offers susceptibility testing using three 
antimycobacterial agents and the laboratory reports correct response for 
two of the three antimycobacterial agents, the laboratory's grade would 
be \2/3\ x 100 = 67 percent.
    (5) The performance criterion for qualitative tests is the presence 
or absence of acid-fast organisms. The score for acid-fast organism 
detection is the number of correct responses divided by the number of 
samples to be tested, multiplied by 100.
    (6) The score for a testing event in mycobacteriology is the average 
of the scores determined under paragraphs (c)(3) through (c)(5) of this 
section based on the type of service offered by the laboratory.

[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.915  Mycology.

    (a) Types of services offered by laboratories. In mycology, there 
are four types of laboratories for proficiency testing purposes that may 
perform different levels of service for yeasts, dimorphic fungi, 
dermatophytes, and aerobic actinomycetes:
    (1) Those that isolate and identify only yeasts and/or dermatophytes 
to the genus level;
    (2) Those that isolate and identify yeasts and/or dermatophytes to 
the species level;
    (3) Those that isolate and perform identification of all organisms 
to the genus level; and
    (4) Those that isolate and perform identification of all organisms 
to the species level.
    (b) Program content and frequency of challenge. To be approved for 
proficiency testing for mycology, the annual program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The samples 
may be provided through mailed shipments or, at HHS' option, may be 
provided to HHS or its designee for on-site testing. An annual program 
must include samples that contain organisms that are representative of 
five major groups of fungi: Yeast or yeast-like fungi; dimorphic fungi; 
dematiaceous fungi; dermatophytes; and saprophytes, including 
opportunistic fungi. The specific fungi included in the samples may vary 
from year to year.
    (1) An approved program must, before each calendar year, furnish HHS 
with a description of samples that it plans to include in its annual 
program no later than six months before each calendar

[[Page 684]]

year. At least 50 percent of the samples must be mixtures of the 
principal organism and appropriate normal background flora. Other 
important emerging pathogens (as determined by HHS) and organisms 
commonly occurring in patient specimens must be included periodically in 
the program.
    (2) An approved program may vary over time. As an example, the types 
of organisms that might be included in an approved program over time 
are--

Candida albicans
Candida (other species)
Cryptococcus neoformans
Sporothrix schenckii
Exophiala jeanselmei
Fonsecaea pedrosoi
Microsporum sp.
Acremonium sp.
Trichophvton sp.
Aspergillus fumigatus
Nocardia sp.
Blastomyces dermatitidis \1\
Zygomycetes sp.
    \1\ Note: Provided as a nonviable sample.

    (c) Evaluation of a laboratory's performance. HHS approves only 
those programs that assess the accuracy of a laboratory's response, in 
accordance with paragraphs (c)(1) through (5) of this section.
    (1) The program determines the reportable organisms. To determine 
the accuracy of a laboratory's response, the program must compare the 
laboratory's response for each sample with the response that reflects 
agreement of either 80 percent of ten or more referee laboratories or 80 
percent or more of all participating laboratories.
    (2) To evaluate a laboratory's response for a particular sample, the 
program must determine a laboratory's type of service in accordance with 
paragraph (a) of this section. A laboratory must isolate and identify 
the organisms to the same extent it performs these procedures on patient 
specimens.
    (3) Since laboratories may incorrectly report the presence of 
organisms in addition to the correctly identified principal organism(s), 
the grading system must deduct credit for additional erroneous organisms 
reported. Therefore, the total number of correct responses submitted by 
the laboratory divided by the number of organisms present plus the 
number of incorrect organisms reported by the laboratory must be 
multiplied by 100 to establish a score for each sample in each shipment 
or testing event. For example, if a sample contained one principal 
organism and the laboratory reported it correctly but reported the 
presence of an additional organism, which was not present, the sample 
grade would be 1/(1 + 1)x100 = 50 percent.
    (4) The score for the antigen tests is the number of correct 
responses divided by the number of samples to be tested for the antigen, 
multiplied by 100.
    (5) The score for a testing event is the average of the sample 
scores as determined under paragraph (c)(3) or (c)(4), or both, of this 
section.

[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.917  Parasitology.

    (a) Types of services offered by laboratories. In parasitology there 
are two types of laboratories for proficiency testing purposes--
    (1) Those that determine the presence or absence of parasites by 
direct observation (wet mount) and/or pinworm preparations and, if 
necessary, refer specimens to another laboratory appropriately certified 
in the subspecialty of parasitology for identification;
    (2) Those that identify parasites using concentration preparations 
and/or permanent stains.
    (b) Program content and frequency of challenge. To be approved for 
proficiency testing in parasitology, a program must provide a minimum of 
five samples per testing event. There must be at least three testing 
events at approximately equal intervals per year. The samples may be 
provided through mailed shipments or, at HHS's option, may be provided 
to HHS or its designee for on-site testing. An annual program must 
include samples that contain parasites that are commonly encountered in 
the United States as well as those recently introduced into the United 
States. Other important emerging pathogens (as determined by HHS) and 
parasites commonly occurring in patient specimens must be included 
periodically in the program.
    (1) An approved program must, before each calendar year furnish HHS 
with a

[[Page 685]]

description of samples that it plans to include in its annual program no 
later than six months before each calendar year. Samples must include 
both formalinized specimens and PVA (polyvinyl alcohol) fixed specimens 
as well as blood smears, as appropriate for a particular parasite and 
stage of the parasite. The majority of samples must contain protozoa or 
helminths or a combination of parasites. Some samples must be devoid of 
parasites.
    (2) An approved program may vary over time. As an example, the types 
of parasites that might be included in an approved program over time 
are--

Enterobius vermicularis
Entamoeba histolytica
Entamoeba coli
Giardia lamblia
Endolimax nana
Dientamoeba fragilis
Iodamoeba butschli
Chilomastix mesnili
Hookworm
Ascaris lumbricoides
Strongyloides stercoralis
Trichuris trichiura
Diphyllobothrium latum
Cryptosporidium sp.
Plasmodium falciparum

    (3) For laboratories specified in paragraph (a)(1) of this section, 
the program must provide at least five samples per testing event that 
include challenges which contain parasites and challenges that are 
devoid of parasites.
    (c) Evaluation of a laboratory's performance. HHS approves only 
those programs that assess the accuracy of a laboratory's responses in 
accordance with paragraphs (c)(1) through (6) of this section.
    (1) The program must determine the reportable parasites. It may 
elect to establish a minimum number of parasites to be identified in 
samples before they are reported. Parasites found in rare numbers by 
referee laboratories are not considered in scoring a laboratory's 
performance; such findings are neutral. To determine the accuracy of a 
laboratory's response, the program must compare the laboratory's 
response with the response that reflects agreement of either 80 percent 
of ten or more referee laboratories or 80 percent or more of all 
participating laboratories.
    (2) To evaluate a laboratory's response for a particular sample, the 
program must determine a laboratory's type of service in accordance with 
paragraph (a) of this section. A laboratory must determine the presence 
or absence of a parasite(s) or concentrate and identify the parasites to 
the same extent it performs these procedures on patient specimens.
    (3) Since laboratories may incorrectly report the presence of 
parasites in addition to the correctly identified principal parasite(s), 
the grading system must deduct credit for these additional erroneous 
parasites reported and not found in rare numbers by the program's 
referencing process. Therefore, the total number of correct responses 
submitted by the laboratory divided by the number of parasites present 
plus the number of incorrect parasites reported by the laboratory must 
be multiplied by 100 to establish a score for each sample in each 
testing event. For example, if a sample contained one principal parasite 
and the laboratory reported it correctly but reported the presence of an 
additional parasite, which was not present, the sample grade would be

1/(1 + 1) x 100 = 50 percent.
    (4) The criterion for acceptable performance for qualitative 
parasitology examinations is presence or absence of a parasite(s).
    (5) The score for parasitology is the number of correct responses 
divided by the number of samples to be tested, multiplied by 100.
    (6) The score for a testing event is the average of the sample 
scores as determined under paragraphs (c)(3) through (c)(5) of this 
section.

[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]



Sec. 493.919  Virology.

    (a) Types of services offered by laboratories. In virology, there 
are two types of laboratories for proficiency testing purposes--
    (1) Those that only perform tests that directly detect viral 
antigens or structures, either in cells derived from infected tissues or 
free in fluid specimens; and
    (2) Those that are able to isolate and identify viruses and use 
direct antigen techniques.

[[Page 686]]

    (b) Program content and frequency of challenge. To be approved for 
proficiency testing in virology, a program must provide a minimum of 
five samples per testing event. There must be at least three testing 
events at approximately equal intervals per year. The samples may be 
provided to the laboratory through mailed shipments or, at HHS's option, 
may be provided to HHS or its designee for on-site testing. An annual 
program must include viral species that are the more commonly identified 
viruses. The specific organisms found in the samples may vary from year 
to year. The annual program must include samples for viral antigen 
detection and viral isolation and identification.
    (1) An approved program must furnish HHS with a description of 
samples that it plans to include in its annual program no later than six 
months before each calendar year. The program must include other 
important emerging viruses (as determined by HHS) and viruses commonly 
occurring in patient specimens.
    (2) An approved program may vary over time. For example, the types 
of viruses that might be included in an approved program over time are 
the more commonly identified viruses such as Herpes simplex, respiratory 
syncytial virus, adenoviruses, enteroviruses, and cytomegaloviruses.
    (c) Evaluation of laboratory's performance. HHS approves only those 
programs that assess the accuracy of a laboratory's response in 
accordance with paragraphs (c)(1) through (5) of this section.
    (1) The program determines the reportable viruses to be detected by 
direct antigen techniques or isolated by laboratories that perform viral 
isolation procedures. To determine the accuracy of a laboratory's 
response, the program must compare the laboratory's response for each 
sample with the response that reflects agreement of either 80 percent of 
ten or more referee laboratories or 80 percent or more of all 
participating laboratories.
    (2) To evaluate a laboratory's response for a particular sample, the 
program must determine a laboratory's type of service in accordance with 
paragraph (a) of this section. A laboratory must isolate and identify 
the viruses to the same extent it performs these procedures on patient 
specimens.
    (3) Since laboratories may incorrectly report the presence of 
viruses in addition to the correctly identified principal virus, the 
grading system must provide a means of deducting credit for additional 
erroneous viruses reported. Therefore, the total number of correct 
responses determined by virus culture techniques submitted by the 
laboratory divided by the number of viruses present plus the number of 
incorrect viruses reported by the laboratory must be multiplied by 100 
to establish a score for each sample in each testing event. For example, 
if a sample contained one principal virus and the laboratory reported it 
correctly but reported the presence of an additional virus, which was 
not present, the sample grade would be 1/(1 + 1) x 100 = 50 percent.
    (4) The performance criterion for qualitative antigen tests is 
presence or absence of the viral antigen. The score for the antigen 
tests is the number of correct responses divided by the number of 
samples to be tested for the antigen, multiplied by 100.
    (5) The score for a testing event is the average of the sample 
scores as determined under paragraph (c)(3) and (c)(4) of this section.

[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]



Sec. 493.921  Diagnostic immunology.

    The subspecialties under the specialty of immunology for which a 
program may offer proficiency testing are syphilis serology and general 
immunology. Specific criteria for these subspecialties are found at 
Sec. Sec. 493.923 and 493.927.



Sec. 493.923  Syphilis serology.

    (a) Program content and frequency of challenge. To be approved for 
proficiency testing in syphilis serology, a program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The samples 
may be provided through mailed shipments or, at HHS' option, may be 
provided to HHS or its designee for on-site testing. An annual program

[[Page 687]]

must include samples that cover the full range of reactivity from highly 
reactive to non-reactive.
    (b) Evaluation of test performance. HHS approves only those programs 
that assess the accuracy of a laboratory's responses in accordance with 
paragraphs (b)(1) through (4) of this section.
    (1) To determine the accuracy of a laboratory's response for 
qualitative and quantitative syphilis tests, the program must compare 
the laboratory's response with the response that reflects agreement of 
either 80 percent of ten or more referee laboratories or 80 percent or 
more of all participating laboratories. The proficiency testing program 
must indicate the minimum concentration, by method, that will be 
considered as indicating a positive response. The score for a sample in 
syphilis serology is the average of scores determined under paragraphs 
(b)(2) and (b)(3) of this section.
    (2) For quantitative syphilis tests, the program must determine the 
correct response for each method by the distance of the response from 
the target value. After the target value has been established for each 
response, the appropriateness of the response must be determined by 
using fixed criteria. The criterion for acceptable performance for 
quantitative syphilis serology tests is the target value 1 dilution.
    (3) The criterion for acceptable performance for qualitative 
syphilis serology tests is reactive or nonreactive.
    (4) To determine the overall testing event score, the number of 
correct responses must be averaged using the following formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022


[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.927  General immunology.

    (a) Program content and frequency of challenge. To be approved for 
proficiency testing for immunology, the annual program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The annual 
program must provide samples that cover the full range of reactivity 
from highly reactive to nonreactive. The samples may be provided through 
mailed shipments or, at HHS' option, may be provided to HHS or its 
designee for on-site testing.
    (b) Challenges per testing event. The minimum number of challenges 
per testing event the program must provide for each analyte or test 
procedure is five. Analytes or tests for which laboratory performance is 
to be evaluated include:

                        Analyte or Test Procedure

Alpha-l antitrypsin
Alpha-fetoprotein (tumor marker)
Antinuclear antibody
Antistreptolysin O
Anti-human immunodeficiency virus (HIV)
Complement C3
Complement C4
Hepatitis markers (HBsAg, anti-HBc, HBeAg)
IgA
IgG
IgE
IgM
Infectious mononucleosis
Rheumatoid factor
Rubella

    (c) Evaluation of a laboratory's analyte or test performance. HHS 
approves only those programs that assess the accuracy of a laboratory's 
responses in accordance with paragraphs (c)(1) through (5) of this 
section.
    (1) To determine the accuracy of a laboratory's response for 
quantitative and qualitative immunology tests or analytes, the program 
must compare the laboratory's response for each analyte with the 
response that reflects agreement of either 80 percent of ten or

[[Page 688]]

more referee laboratories or 80 percent or more of all participating 
laboratories. The proficiency testing program must indicate the minimum 
concentration that will be considered as indicating a positive response. 
The score for a sample in general immunology is either the score 
determined under paragraph (c)(2) or (3) of this section.
    (2) For quantitative immunology analytes or tests, the program must 
determine the correct response for each analyte by the distance of the 
response from the target value. After the target value has been 
established for each response, the appropriateness of the response must 
be determined by using either fixed criteria or the number of standard 
deviations (SDs) the response differs from the target value.

                   Criteria for Acceptable Performance

    The criteria for acceptable performance are--

------------------------------------------------------------------------
                                               Criteria for acceptable
              Analyte or test                        performance
------------------------------------------------------------------------
Alpha-1 antitrypsin.......................  Target value 3 SD.
Alpha-fetoprotein (tumor marker)..........  Target value 3 SD.
Antinuclear antibody......................  Target value 2 dilutions or
                                             positive or negative.
Antistreptolysin O........................  Target value 2 dilution or
                                             positive or negative.
Anti-Human Immunodeficiency virus.........  Reactive or nonreactive.
Complement C3.............................  Target value 3 SD.
Complement C4.............................  Target value 3 SD.
Hepatitis (HBsAg, anti-HBc, HBeAg)........  Reactive (positive) or
                                             nonreactive (negative).
IgA.......................................  Target value 3 SD.
IgE.......................................  Target value 3 SD.
IgG.......................................  Target value 25%.
IgM.......................................  Target value 3 SD.
Infectious mononucleosis..................  Target value 2 dilutions or
                                             positive or negative.
Rheumatoid factor.........................  Target value 2 dilutions or
                                             positive or negative.
Rubella...................................  Target value 2 dilutions or
                                             immune or nonimmune or
                                             positive or negative.
------------------------------------------------------------------------

    (3) The criterion for acceptable performance for qualitative general 
immunology tests is positive or negative.
    (4) To determine the analyte testing event score, the number of 
acceptable analyte responses must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.023

    (5) To determine the overall testing event score, the number of 
correct responses for all analytes must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022


[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.929  Chemistry.

    The subspecialties under the specialty of chemistry for which a 
proficiency testing program may offer proficiency testing are routine 
chemistry, endocrinology, and toxicology. Specific criteria for these 
subspecialties are listed in Sec. Sec. 493.931 through 493.939.



Sec. 493.931  Routine chemistry.

    (a) Program content and frequency of challenge. To be approved for 
proficiency testing for routine chemistry, a program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The annual 
program must provide samples that cover the clinically relevant range of 
values that would be expected in patient specimens. The specimens

[[Page 689]]

may be provided through mailed shipments or, at HHS' option, may be 
provided to HHS or its designee for on-site testing.
    (b) Challenges per testing event. The minimum number of challenges 
per testing event a program must provide for each analyte or test 
procedure listed below is five serum, plasma or blood samples.

                        Analyte or Test Procedure

Alanine aminotransferase (ALT/SGPT)
Albumin
Alkaline phosphatase
Amylase
Aspartate aminotransferase (AST/SGOT)
Bilirubin, total
Blood gas (pH, pO2, and pCO2)
Calcium, total
Chloride
Cholesterol, total
Cholesterol, high density lipoprotein
Creatine kinase
Creatine kinase, isoenzymes
Creatinine
Glucose (Excluding measurements on devices cleared by FDA for home use)
Iron, total
Lactate dehydrogenase (LDH)
LDH isoenzymes
Magnesium
Potassium
Sodium
Total Protein
Triglycerides
Urea Nitrogen
Uric Acid

    (c) Evaluation of a laboratory's analyte or test performance. HHS 
approves only those programs that assess the accuracy of a laboratory's 
responses in accordance with paragraphs (c)(1) through (5) of this 
section.
    (1) To determine the accuracy of a laboratory's response for 
qualitative and quantitative chemistry tests or analytes, the program 
must compare the laboratory's response for each analyte with the 
response that reflects agreement of either 80 percent of ten or more 
referee laboratories or 80 percent or more of all participating 
laboratories. The score for a sample in routine chemistry is either the 
score determined under paragraph (c)(2) or (3) of this section.
    (2) For quantitative chemistry tests or analytes, the program must 
determine the correct response for each analyte by the distance of the 
response from the target value. After the target value has been 
established for each response, the appropriateness of the response must 
be determined by using either fixed criteria based on the percentage 
difference from the target value or the number of standard deviations 
(SDs) the response differs from the target value.

                   Criteria for Acceptable Performance

    The criteria for acceptable performance are--

------------------------------------------------------------------------
                                               Criteria for acceptable
              Analyte or test                        performance
------------------------------------------------------------------------
Alanine aminotransferase (ALT/SGPT).......  Target value 20%.
Albumin...................................  Target value 10%.
Alkaline phosphatase......................  Target value 30%.
Amylase...................................  Target value 30%.
Aspartate aminotransferase (AST/SGOT).....  Target value 20%.
Bilirubin, total..........................  Target value 0.4 mg/dL or 20%
                                             (greater).
Blood gas pO2.............................  Target value 3 SD.
pCO2......................................  Target value 5 mm Hg or 8%
                                             (greater).
pH........................................  Target value 0.04.
Calcium, total............................  Target value 1.0 mg/dL.
Chloride..................................  Target value 5%.
Cholesterol, total........................  Target value 10%.
Cholesterol, high density lipoprotein.....  Target value 30%.
Creatine kinase...........................  Target value 30%.
Creatine kinase isoenzymes................  MB elevated (presence or
                                             absence) or Target value
                                             3SD.
Creatinine................................  Target value 0.3 mg/dL or 15%
                                             (greater).
Glucose (excluding glucose performed on     Target value 6 mg/dl or 10%
                                             (greater).
Iron, total...............................  Target value 20%.
Lactate dehydrogenase (LDH)...............  Target value 20%.
LDH isoenzymes............................  LDH1/LDH2 (+ or -) or Target
                                             value 30%.
Magnesium.................................  Target value 25%.
Potassium.................................  Target value 0.5 mmol/L.
Sodium....................................  Target value 4 mmol/L.
Total Protein.............................  Target value 10%.
Triglycerides.............................  Target value 25%.
Urea nitrogen.............................  Target value 2 mg/dL or 9%
                                             (greater).
Uric acid.................................  Target value 17%.
------------------------------------------------------------------------

    (3) The criterion for acceptable performance for qualitative routine 
chemistry tests is positive or negative.
    (4) To determine the analyte testing event score, the number of 
acceptable analyte responses must be averaged using the following 
formula:

[[Page 690]]

[GRAPHIC] [TIFF OMITTED] TR25SE06.023

    (5) To determine the overall testing event score, the number of 
correct responses for all analytes must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022


[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]



Sec. 493.933  Endocrinology.

    (a) Program content and frequency of challenge. To be approved for 
proficiency testing for endocrinology, a program must provide a minimum 
of five samples per testing event. There must be at least three testing 
events at approximately equal intervals per year. The annual program 
must provide samples that cover the clinically relevant range of values 
that would be expected in patient specimens. The samples may be provided 
through mailed shipments or, at HHS' option, may be provided to HHS or 
its designee for on-site testing.
    (b) Challenges per testing event. The minimum number of challenges 
per testing event a program must provide for each analyte or test 
procedure is five serum, plasma, blood, or urine samples.

                             Analyte or Test

Cortisol
Free Thyroxine
Human Chorionic gonadotropin (excluding urine pregnancy tests done by 
visual color comparison categorized as waived tests)
T3 Uptake
Triiodothyronine
Thyroid-stimulating hormone
Thyroxine

    (c) Evaluation of a laboratory's analyte or test performance. HHS 
approves only those programs that assess the accuracy of a laboratory's 
responses in accordance with paragraphs (c)(1) through (5) of this 
section.
    (1) To determine the accuracy of a laboratory's response for 
qualitative and quantitative endocrinology tests or analytes, a program 
must compare the laboratory's response for each analyte with the 
response that reflects agreement of either 80 percent of ten or more 
referee laboratories or 80 percent or more of all participating 
laboratories. The score for a sample in endocrinology is either the 
score determined under paragraph (c)(2) or (c)(3) of this section.
    (2) For quantitative endocrinology tests or analytes, the program 
must determine the correct response for each analyte by the distance of 
the response from the target value. After the target value has been 
established for each response, the appropriateness of the response must 
be determined by using either fixed criteria based on the percentage 
difference from the target value or the number of standard deviations 
(SDs) the response differs from the target value.

                   Criteria for Acceptable Performance

    The criteria for acceptable performance are--

------------------------------------------------------------------------
                                               Criteria for acceptable
              Analyte or test                        performance
------------------------------------------------------------------------
Cortisol..................................  Target value 25%.
Free Thyroxine............................  Target value 3 SD.
Human Chorionic Gonadotropin (excluding     Target value 3 SD positive or
 color comparison categorized as waived      negative.
 tests).
T3 Uptake.................................  Target value 3 SD.
Triiodothyronine..........................  Target value 3 SD.
Thyroid-stimulating hormone...............  Target value 3 SD.
Thyroxine.................................  Target value 20% or 1.0 mcg/dL
                                             (greater).
------------------------------------------------------------------------


[[Page 691]]

    (3) The criterion for acceptable performance for qualitative 
endocrinology tests is positive or negative.
    (4) To determine the analyte testing event score, the number of 
acceptable analyte responses must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.023

    (5) To determine the overall testing event score, the number of 
correct responses for all analytes must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022


[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.937  Toxicology.

    (a) Program content and frequency of challenge. To be approved for 
proficiency testing for toxicology, the annual program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The annual 
program must provide samples that cover the clinically relevant range of 
values that would be expected in specimens of patients on drug therapy 
and that cover the level of clinical significance for the particular 
drug. The samples may be provided through mailed shipments or, at HHS' 
option, may be provided to HHS or its designee for on-site testing.
    (b) Challenges per testing event. The minimum number of challenges 
per testing event a program must provide for each analyte or test 
procedure is five serum, plasma, or blood samples.

                        Analyte or Test Procedure

Alcohol (blood)
Blood lead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide
 (and metabolite)
Quinidine
Theophylline
Tobramycin
Valproic Acid

    (c) Evaluation of a laboratory's analyte or test performance. HHS 
approves only those programs that assess the accuracy of a laboratory's 
responses in accordance with paragraphs (c)(1) through (4) of this 
section.
    (1) To determine the accuracy of a laboratory's responses for 
quantitative toxicology tests or analytes, the program must compare the 
laboratory's response for each analyte with the response that reflects 
agreement of either 80 percent of ten or more referee laboratories or 80 
percent or more of all participating laboratories. The score for a 
sample in toxicology is the score determined under paragraph (c)(2) of 
this section.
    (2) For quantitative toxicology tests or analytes, the program must 
determine the correct response for each analyte by the distance of the 
response from the target value. After the target value has been 
established for each response, the appropriateness of the response must 
be determined by using fixed criteria based on the percentage difference 
from the target value

                   Criteria for Acceptable Performance

    The criteria for acceptable performance are:

------------------------------------------------------------------------
                                               Criteria for acceptable
              Analyte or test                        performance
------------------------------------------------------------------------
Alcohol, blood............................  Target Value 25%.
Blood lead................................  Target Value 10% or 4 mcg/dL
                                             (greater).

[[Page 692]]

 
Carbamazepine.............................  Target Value 25%.
Digoxin...................................  Target Value 20% or 0.2 ng/mL
                                             (greater).
Ethosuximide..............................  Target Value 20%.
Gentamicin................................  Target Value 25%.
Lithium...................................  Target Value 0.3 mmol/L or 20%
                                             (greater).
Phenobarbital.............................  Target Value 20%
Phenytoin.................................  Target Value 25%.
Primidone.................................  Target Value 25%.
Procainamide (and metabolite).............  Target Value 25%.
Quinidine.................................  Target Value 25%.
Tobramycin................................  Target Value 25%.
Theophylline..............................  Target Value 25%.
Valproic Acid.............................  Target Value 25%.
------------------------------------------------------------------------

    (3) To determine the analyte testing event score, the number of 
acceptable analyte responses must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.023

    (4) To determine the overall testing event score, the number of 
correct responses for all analytes must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022


[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.941  Hematology (including routine hematology and coagulation).

    (a) Program content and frequency of challenge. To be approved for 
proficiency testing for hematology, a program must provide a minimum of 
five samples per testing event. There must be at least three testing 
events at approximately equal intervals per year. The annual program 
must provide samples that cover the full range of values that would be 
expected in patient specimens. The samples may be provided through 
mailed shipments or, at HHS' option, may be provided to HHS and or its 
designee for on-site testing.
    (b) Challenges per testing event. The minimum number of challenges 
per testing event a program must provide for each analyte or test 
procedure is five.

                        Analyte or Test Procedure

Cell identification or white blood cell differential
Erythrocyte count
Hematocrit (excluding spun microhematocrit)
Hemoglobin
Leukocyte count
Platelet count
Fibrinogen
Partial thromboplastin time
Prothrombin time

    (1) An approved program for cell identification may vary over time. 
The types of cells that might be included in an approved program over 
time are--

Neutrophilic granulocytes
Eosinophilic granulocytes
Basophilic granulocytes
Lymphocytes
Monocytes
Major red and white blood cell abnormalities
Immature red and white blood cells

    (2) White blood cell differentials should be limited to the 
percentage distribution of cellular elements listed above.
    (c) Evaluation of a laboratory's analyte or test performance. HHS 
approves only those programs that assess the accuracy of a laboratory's 
responses in accordance with paragraphs (c) (1) through (5) of this 
section.

[[Page 693]]

    (1) To determine the accuracy of a laboratory's responses for 
qualitative and quantitative hematology tests or analytes, the program 
must compare the laboratory's response for each analyte with the 
response that reflects agreement of either 80 percent of ten or more 
referee laboratories or 80 percent or more of all participating 
laboratories. The score for a sample in hematology is either the score 
determined under paragraph (c) (2) or (3) of this section.
    (2) For quantitative hematology tests or analytes, the program must 
determine the correct response for each analyte by the distance of the 
response from the target value. After the target value has been 
established for each response, the appropriateness of the response is 
determined using either fixed criteria based on the percentage 
difference from the target value or the number of standard deviations 
(SDs) the response differs from the target value.

                   Criteria for Acceptable Performance

    The criteria for acceptable performance are:

------------------------------------------------------------------------
                                               Criteria for acceptable
              Analyte or test                        performance
------------------------------------------------------------------------
Cell identification.......................  90% or greater consensus on
                                             identification.
White blood cell differential.............  Target 3SD based on the
                                             percentage of different
                                             types of white blood cells
                                             in the samples.
Erythrocyte count.........................  Target 6%.
Hematocrit (Excluding spun hematocrits)...  Target 6%.
Hemoglobin................................  Target 7%.
Leukocyte count...........................  Target 15%.
Platelet count............................  Target 25%.
Fibrinogen................................  Target 20%.
Partial thromboplastin time...............  Target 15%.
Prothrombin time..........................  Target 15%.
------------------------------------------------------------------------

    (3) The criterion for acceptable performance for the qualitative 
hematology test is correct cell identification.
    (4) To determine the analyte testing event score, the number of 
acceptable analyte responses must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.023

    (5) To determine the overall testing event score, the number of 
correct responses for all analytes must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022


[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.945  Cytology; gynecologic examinations.

    (a) Program content and frequency of challenge. (1) To be approved 
for proficiency testing for gynecologic examinations (Pap smears) in 
cytology, a program must provide test sets composed of 10- and 20-glass 
slides. Proficiency testing programs may obtain slides for test sets 
from cytology laboratories, provided the slides have been retained by 
the laboratory for the required period specified in Sec. Sec. 
493.1105(a)(7)(i)(A) and 493.1274(f)(2). If slide preparations are still 
subject to retention by the laboratory, they may be loaned to a 
proficiency testing program if the program provides the laboratory with 
documentation of the loan of the slides and ensures that slides loaned 
to it are retrievable upon request. Each test set must include at least 
one slide representing each of the

[[Page 694]]

response categories described in paragraph (b)(3)(ii)(A) of this 
section, and test sets should be comparable so that equitable testing is 
achieved within and between proficiency testing providers.
    (2) To be approved for proficiency testing in gynecologic cytology, 
a program must provide announced and unannounced on-site testing for 
each individual at least once per year and must provide an initial 
retesting event for each individual within 45 days after notification of 
test failure and subsequent retesting events within 45 days after 
completion of remedial action described in Sec. 493.855.
    (b) Evaluation of an individual's performance. HHS approves only 
those programs that assess the accuracy of each individual's responses 
on both 10- and 20-slide test sets in which the slides have been 
referenced as specified in paragraph (b)(1) of this section.
    (1) To determine the accuracy of an individual's response on a 
particular challenge (slide), the program must compare the individual's 
response for each slide preparation with the response that reflects the 
predetermined consensus agreement or confirmation on the diagnostic 
category, as described in the table in paragraph (b)(3)(ii)(A) of this 
section. For all slide preparations, a 100% consensus agreement among a 
minimum of three physicians certified in anatomic pathology is required. 
In addition, for premalignant and malignant slide preparations, 
confirmation by tissue biopsy is required either by comparison of the 
reported biopsy results or reevaluation of biopsy slide material by a 
physician certified in anatomic pathology.
    (2) An individual qualified as a technical supervisor under Sec. 
493.1449 (b) or (k) who routinely interprets gynecologic slide 
preparations only after they have been examined by a cytotechnologist 
can either be tested using a test set that has been screened by a 
cytotechnologist in the same laboratory or using a test set that has not 
been screened. A technical supervisor who screens and interprets slide 
preparations that have not been previously examined must be tested using 
a test set that has not been previously screened.
    (3) The criteria for acceptable performance are determined by using 
the scoring system in paragraphs (b)(3) (i) and (ii) of this section.
    (i) Each slide set must contain 10 or 20 slides with point values 
established for each slide preparation based on the significance of the 
relationship of the interpretation of the slide to a clinical condition 
and whether the participant in the testing event is a cytotechnologist 
qualified under Sec. 493.1469 or Sec. 493.1483 or functioning as a 
technical supervisor in cytology qualified under Sec. 493.1449 (b) or 
(k) of this part.
    (ii) The scoring system rewards or penalizes the participants in 
proportion to the distance of their answers from the correct response or 
target diagnosis and the penalty or reward is weighted in proportion to 
the severity of the lesion.
    (A) The four response categories for reporting proficiency testing 
results and their descriptions are as follows:

------------------------------------------------------------------------
             Category                            Description
------------------------------------------------------------------------
A.................................  Unsatisfactory for diagnosis due to:
                                    (1) Scant cellularity.
                                    (2) Air drying.
                                    (3) Obscuring material (blood,
                                     inflammatory cells, or lubricant).
B.................................  Normal or Benign Changes--includes:
                                    (1) Normal, negative or within
                                     normal limits.
                                    (2) Infection other than Human
                                     Papillomavirus (HPV) (e.g.,
                                     Trichomonas vaginalis, changes or
                                     morphology consistent with Candida
                                     spp., Actinomyces spp. or Herpes
                                     simplex virus).
                                    (3) Reactive and reparative changes
                                     (e.g., inflammation, effects of
                                     chemotherapy or radiation).
C.................................  Low Grade Squamous Intraepithelial
                                     Lesion--includes:
                                    (1) Cellular changes associated with
                                     HPV.
                                    (2) Mild dysplasia/CIN-1.
D.................................  High Grade Lesion and Carcinoma--
                                     includes:
                                    (1) High grade squamous
                                     intraepithelial lesions which
                                     include moderate dysplasia/CIN-2
                                     and severe dysplasia/carcinoma in-
                                     situ/CIN-3.
                                    (2) Squamous cell carcinoma.
                                    (3) Adenocarcinoma and other
                                     malignant neoplasms.
------------------------------------------------------------------------


[[Page 695]]

    (B) In accordance with the criteria for the scoring system, the 
charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for 
technical supervisors and cytotechnologists, respectively, provide a 
maximum of 10 points for a correct response and a maximum of minus five 
(-5) points for an incorrect response on a 10-slide test set. For 
example, if the correct response on a slide is ``high grade squamous 
intraepithelial lesion'' (category ``D'' on the scoring system chart) 
and an examinee calls it ``normal or negative'' (category ``B'' on the 
scoring system chart), then the examinee's point value on that slide is 
calculated as minus five (-5). Each slide is scored individually in the 
same manner. The individual's score for the testing event is determined 
by adding the point value achieved for each slide preparation, dividing 
by the total points for the testing event and multiplying by 100.
    (C) Criteria for scoring system for a 10-slide test set. (See table 
at (b)(3)(ii)(A) of this section for a description of the response 
categories.) For technical supervisors qualified under Sec. 493.1449(b) 
or (k):

------------------------------------------------------------------------
                Examinee's response:                   A    B    C    D
------------------------------------------------------------------------
Correct response category:
  A.................................................   10    0    0    0
  B.................................................    5   10    0    0
  C.................................................    5    0   10    5
  D.................................................    0   -5    5   10
------------------------------------------------------------------------

    (D) Criteria for scoring system for a 10-slide test set. (See table 
at paragraph (b)(3)(ii)(A) of this section for a description of the 
response categories.) For cytotechnologists qualified under Sec. 
493.1469 or Sec. 493.1483:

------------------------------------------------------------------------
                Examinee's response:                   A    B    C    D
------------------------------------------------------------------------
Correct response category:
  A.................................................   10    0    5    5
  B.................................................    5   10    5    5
  C.................................................    5    0   10   10
  D.................................................    0   -5   10   10
------------------------------------------------------------------------

    (E) In accordance with the criteria for the scoring system, the 
charts in paragraphs (b)(3)(ii)(F) and (G) of this section, for 
technical supervisors and cytotechnologists, respectively, provide 
maximums of 5 points for a correct response and minus ten (-10) points 
for an incorrect response on a 20-slide test set.
    (F) Criteria for scoring system for a 20-slide test set. (See table 
at paragraph (b)(3)(ii)(A) of this section for a description of the 
response categories.) For technical supervisors qualified under Sec. 
493.1449(b) or (k):

------------------------------------------------------------------------
             Examinee's response:                 A      B      C     D
------------------------------------------------------------------------
Correct response category:
  A...........................................   5         0   0     0
  B...........................................   2.5       5   0     0
  C...........................................   2.5       0   5     2.5
  D...........................................   0       -10   2.5   5
------------------------------------------------------------------------

    (G) Criteria for scoring system for a 20-slide test set. (See table 
at (b)(3)(ii)(A) of this section for a description of the response 
categories.) For cytotechnologists qualified under Sec. 493.1469 or 
Sec. 493.1483:

------------------------------------------------------------------------
              Examinee's response:                 A     B      C     D
------------------------------------------------------------------------
Correct response category:
  A............................................   5        0   2.5   2.5
  B............................................   2.5      5   2.5   2.5
  C............................................   2.5      0   5     5
  D............................................   0      -10   5     5
------------------------------------------------------------------------


[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 
FR 3702, Jan. 24, 2003]



Sec. 493.959  Immunohematology.

    (a) Types of services offered by laboratories. In immunohematology, 
there are four types of laboratories for proficiency testing purposes--
    (1) Those that perform ABO group and/or D (Rho) typing;
    (2) Those that perform ABO group and/or D (Rho) typing, and 
unexpected antibody detection;
    (3) Those that in addition to paragraph (a)(2) of this section 
perform compatibility testing; and
    (4) Those that perform in addition to paragraph (a)(3) of this 
section antibody identification.
    (b) Program content and frequency of challenge. To be approved for 
proficiency testing for immunohematology, a program must provide a 
minimum of five samples per testing event. There must be at least three 
testing events at approximately equal intervals per year. The annual 
program must provide samples that cover the full range of interpretation 
that would be expected in patient specimens. The samples may be provided 
through mailed shipments or, at

[[Page 696]]

HHS' option, may be provided to HHS or its designee for on-site testing.
    (c) Challenges per testing event. The minimum number of challenges 
per testing event a program must provide for each analyte or test 
procedure is five.

                        Analyte or Test Procedure

ABO group (excluding subgroups)
D (Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification

    (d) Evaluation of a laboratory's analyte or test performance. HHS 
approves only those programs that assess the accuracy of a laboratory's 
response in accordance with paragraphs (d)(1) through (5) of this 
section.
    (1) To determine the accuracy of a laboratory's response, a program 
must compare the laboratory's response for each analyte with the 
response that reflects agreement of either 100 percent of ten or more 
referee laboratories or 95 percent or more of all participating 
laboratories except for unexpected antibody detection and antibody 
identification. To determine the accuracy of a laboratory's response for 
unexpected antibody detection and antibody identification, a program 
must compare the laboratory's response for each analyte with the 
response that reflects agreement of either 95 percent of ten or more 
referee laboratories or 95 percent or more of all participating 
laboratories. The score for a sample in immunohematology is either the 
score determined under paragraph (d)(2) or (3) of this section.
    (2) Criteria for acceptable performance. The criteria for acceptable 
performance are--

------------------------------------------------------------------------
                                               Criteria for acceptable
              Analyte or test                        performance
------------------------------------------------------------------------
ABO group.................................  100% accuracy.
D (Rho) typing............................  100% accuracy.
Unexpected antibody detection.............  80% accuracy.
Compatibility testing.....................  100% accuracy.
Antibody identification...................  80% accuracy.
------------------------------------------------------------------------

    (3) The criterion for acceptable performance for qualitative 
immunohematology tests is positive or negative.
    (4) To determine the analyte testing event score, the number of 
acceptable analyte responses must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.023

    (5) To determine the overall testing event score, the number of 
correct responses for all analytes must be averaged using the following 
formula:
[GRAPHIC] [TIFF OMITTED] TR25SE06.022



         Subpart J_Facility Administration for Nonwaived Testing

    Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.



Sec. 493.1100  Condition: Facility administration.

    Each laboratory that performs nonwaived testing must meet the 
applicable requirements under Sec. Sec. 493.1101 through 493.1105, 
unless HHS approves a procedure that provides equivalent quality testing 
as specified in Appendix C of the State Operations Manual (CMS Pub. 7).
    (a) Reporting of SARS-CoV-2 test results. During the Public Health 
Emergency, as defined in Sec. 400.200 of this chapter, each laboratory 
that performs

[[Page 697]]

a test that is intended to detect SARS-CoV-2 or to diagnose a possible 
case of COVID-19 (hereinafter referred to as a ``SARS-CoV-2 test'') must 
report SARS-CoV-2 test results to the Secretary in such form and manner, 
and at such timing and frequency, as the Secretary may prescribe.
    (b) [Reserved]

[68 FR 3703, Jan. 24, 2003, as amended at 85 FR 54873, Sept. 2, 2020]



Sec. 493.1101  Standard: Facilities.

    (a) The laboratory must be constructed, arranged, and maintained to 
ensure the following:
    (1) The space, ventilation, and utilities necessary for conducting 
all phases of the testing process.
    (2) Contamination of patient specimens, equipment, instruments, 
reagents, materials, and supplies is minimized.
    (3) Molecular amplification procedures that are not contained in 
closed systems have a uni-directional workflow. This must include 
separate areas for specimen preparation, amplification and product 
detection, and, as applicable, reagent preparation.
    (b) The laboratory must have appropriate and sufficient equipment, 
instruments, reagents, materials, and supplies for the type and volume 
of testing it performs.
    (c) The laboratory must be in compliance with applicable Federal, 
State, and local laboratory requirements.
    (d) Safety procedures must be established, accessible, and observed 
to ensure protection from physical, chemical, biochemical, and 
electrical hazards, and biohazardous materials.
    (e) Records and, as applicable, slides, blocks, and tissues must be 
maintained and stored under conditions that ensure proper preservation.



Sec. 493.1103  Standard: Requirements for transfusion services.

    A facility that provides transfusion services must meet all of the 
requirements of this section and document all transfusion-related 
activities.
    (a) Arrangement for services. The facility must have a transfusion 
service agreement reviewed and approved by the responsible party(ies) 
that govern the procurement, transfer, and availability of blood and 
blood products.
    (b) Provision of testing. The facility must provide prompt ABO 
grouping, D(Rho) typing, unexpected antibody detection, compatibility 
testing, and laboratory investigation of transfusion reactions on a 
continuous basis through a CLIA-certified laboratory or a laboratory 
meeting equivalent requirements as determined by CMS.
    (c) Blood and blood products storage and distribution. (1) If a 
facility stores or maintains blood or blood products for transfusion 
outside of a monitored refrigerator, the facility must ensure the 
storage conditions, including temperature, are appropriate to prevent 
deterioration of the blood or blood product.
    (2) The facility must establish and follow policies to ensure 
positive identification of a blood or blood product beneficiary.
    (d) Investigation of transfusion reactions. The facility must have 
procedures for preventing transfusion reactions and when necessary, 
promptly identify, investigate, and report blood and blood product 
transfusion reactions to the laboratory and, as appropriate, to Federal 
and State authorities.



Sec. 493.1105  Standard: Retention requirements.

    (a) The laboratory must retain its records and, as applicable, 
slides, blocks, and tissues as follows:
    (1) Test requisitions and authorizations. Retain records of test 
requisitions and test authorizations, including the patient's chart or 
medical record if used as the test requisition or authorization, for at 
least 2 years.
    (2) Test procedures. Retain a copy of each test procedure for at 
least 2 years after a procedure has been discontinued. Each test 
procedure must include the dates of initial use and discontinuance.
    (3) Analytic systems records. Retain quality control and patient 
test records (including instrument printouts, if applicable) and records 
documenting all analytic systems activities specified in Sec. Sec. 
493.1252 through 493.1289 for at least 2 years. In addition, retain the 
following:

[[Page 698]]

    (i) Records of test system performance specifications that the 
laboratory establishes or verifies under Sec. 493.1253 for the period 
of time the laboratory uses the test system but no less than 2 years.
    (ii) Immunohematology records, blood and blood product records, and 
transfusion records as specified in 21 CFR 606.160(b)(3)(ii), 
(b)(3)(iv), (b)(3)(v) and (d).
    (4) Proficiency testing records. Retain all proficiency testing 
records for at least 2 years.
    (5) Quality system assessment records. Retain all laboratory quality 
systems assessment records for at least 2 years.
    (6) Test reports. Retain or be able to retrieve a copy of the 
original report (including final, preliminary, and corrected reports) at 
least 2 years after the date of reporting. In addition, retain the 
following:
    (i) Immunohematology reports as specified in 21 CFR 606.160(d).
    (ii) Pathology test reports for at least 10 years after the date of 
reporting.
    (7) Slide, block, and tissue retention--(i) Slides. (A) Retain 
cytology slide preparations for at least 5 years from the date of 
examination (see Sec. 493.1274(f) for proficiency testing exception).
    (B) Retain histopathology slides for at least 10 years from the date 
of examination.
    (ii) Blocks. Retain pathology specimen blocks for at least 2 years 
from the date of examination.
    (iii) Tissue. Preserve remnants of tissue for pathology examination 
until a diagnosis is made on the specimen.
    (b) If the laboratory ceases operation, the laboratory must make 
provisions to ensure that all records and, as applicable, slides, 
blocks, and tissue are retained and available for the time frames 
specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]



             Subpart K_Quality System for Nonwaived Testing

    Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.



Sec. 493.1200  Introduction.

    (a) Each laboratory that performs nonwaived testing must establish 
and maintain written policies and procedures that implement and monitor 
a quality system for all phases of the total testing process (that is, 
preanalytic, analytic, and postanalytic) as well as general laboratory 
systems.
    (b) The laboratory's quality systems must include a quality 
assessment component that ensures continuous improvement of the 
laboratory's performance and services through ongoing monitoring that 
identifies, evaluates and resolves problems.
    (c) The various components of the laboratory's quality system are 
used to meet the requirements in this part and must be appropriate for 
the specialties and subspecialties of testing the laboratory performs, 
services it offers, and clients it serves.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1201  Condition: Bacteriology.

    If the laboratory provides services in the subspecialty of 
Bacteriology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1261, and Sec. Sec. 
493.1281 through 493.1299.



Sec. 493.1202  Condition: Mycobacteriology.

    If the laboratory provides services in the subspecialty of 
Mycobacteriology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1262, and Sec. Sec. 
493.1281 through 493.1299.



Sec. 493.1203  Condition: Mycology.

    If the laboratory provides services in the subspecialty of Mycology, 
the laboratory must meet the requirements specified in Sec. Sec. 
493.1230 through 493.1256, Sec. 493.1263, and Sec. Sec. 493.1281 
through 493.1299.



Sec. 493.1204  Condition: Parasitology.

    If the laboratory provides services in the subspecialty of 
Parasitology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through

[[Page 699]]

493.1256, Sec. 493.1264, and Sec. Sec. 493.1281 through 493.1299.



Sec. 493.1205  Condition: Virology.

    If the laboratory provides services in the subspecialty of Virology, 
the laboratory must meet the requirements specified in Sec. Sec. 
493.1230 through 493.1256, Sec. 493.1265, and Sec. Sec. 493.1281 
through 493.1299.



Sec. 493.1207  Condition: Syphilis serology.

    If the laboratory provides services in the subspecialty of Syphilis 
serology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.



Sec. 493.1208  Condition: General immunology.

    If the laboratory provides services in the subspecialty of General 
immunology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1210  Condition: Routine chemistry.

    If the laboratory provides services in the subspecialty of Routine 
chemistry, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1267, and Sec. Sec. 
493.1281 through 493.1299.



Sec. 493.1211  Condition: Urinalysis.

    If the laboratory provides services in the subspecialty of 
Urinalysis, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.



Sec. 493.1212  Condition: Endocrinology.

    If the laboratory provides services in the subspecialty of 
Endocrinology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.



Sec. 493.1213  Condition: Toxicology.

    If the laboratory provides services in the subspecialty of 
Toxicology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.



Sec. 493.1215  Condition: Hematology.

    If the laboratory provides services in the specialty of Hematology, 
the laboratory must meet the requirements specified in Sec. Sec. 
493.1230 through 493.1256, Sec. 493.1269, and Sec. Sec. 493.1281 
through 493.1299.



Sec. 493.1217  Condition: Immunohematology.

    If the laboratory provides services in the specialty of 
Immunohematology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1271, and Sec. Sec. 
493.1281 through 493.1299.



Sec. 493.1219  Condition: Histopathology.

    If the laboratory provides services in the subspecialty of 
Histopathology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1273, and Sec. Sec. 
493.1281 through 493.1299.



Sec. 493.1220  Condition: Oral pathology.

    If the laboratory provides services in the subspecialty of Oral 
pathology, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.



Sec. 493.1221  Condition: Cytology.

    If the laboratory provides services in the subspecialty of Cytology, 
the laboratory must meet the requirements specified in Sec. Sec. 
493.1230 through 493.1256, Sec. 493.1274, and Sec. Sec. 493.1281 
through 493.1299.



Sec. 493.1225  Condition: Clinical cytogenetics.

    If the laboratory provides services in the specialty of Clinical 
cytogenetics, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1276, and Sec. Sec. 
493.1281 through 493.1299.



Sec. 493.1226  Condition: Radiobioassay.

    If the laboratory provides services in the specialty of 
Radiobioassay, the laboratory must meet the requirements specified in 
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through 
493.1299.

[[Page 700]]



Sec. 493.1227  Condition: Histocompatibility.

    If the laboratory provides services in the specialty of 
Histocompatibility, the laboratory must meet the requirements specified 
in Sec. Sec. 493.1230 through 493.1256, Sec. 493.1278, and Sec. Sec. 
493.1281 through 493.1299.

                       General Laboratory Systems



Sec. 493.1230  Condition: General laboratory systems.

    Each laboratory that performs nonwaived testing must meet the 
applicable general laboratory systems requirements in Sec. Sec. 
493.1231 through 493.1236, unless HHS approves a procedure, specified in 
Appendix C of the State Operations Manual (CMS Pub. 7), that provides 
equivalent quality testing. The laboratory must monitor and evaluate the 
overall quality of the general laboratory systems and correct identified 
problems as specified in Sec. 493.1239 for each specialty and 
subspecialty of testing performed.



Sec. 493.1231  Standard: Confidentiality of patient information.

    The laboratory must ensure confidentiality of patient information 
throughout all phases of the total testing process that are under the 
laboratory's control.



Sec. 493.1232  Standard: Specimen identification and integrity.

    The laboratory must establish and follow written policies and 
procedures that ensure positive identification and optimum integrity of 
a patient's specimen from the time of collection or receipt of the 
specimen through completion of testing and reporting of results.



Sec. 493.1233  Standard: Complaint investigations.

    The laboratory must have a system in place to ensure that it 
documents all complaints and problems reported to the laboratory. The 
laboratory must conduct investigations of complaints, when appropriate.



Sec. 493.1234  Standard: Communications.

    The laboratory must have a system in place to identify and document 
problems that occur as a result of a breakdown in communication between 
the laboratory and an authorized person who orders or receives test 
results.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1235  Standard: Personnel competency assessment policies.

    As specified in the personnel requirements in subpart M, the 
laboratory must establish and follow written policies and procedures to 
assess employee and, if applicable, consultant competency.



Sec. 493.1236  Standard: Evaluation of proficiency testing 
performance.

    (a) The laboratory must review and evaluate the results obtained on 
proficiency testing performed as specified in subpart H of this part.
    (b) The laboratory must verify the accuracy of the following:
    (1) Any analyte or subspecialty without analytes listed in subpart I 
of this part that is not evaluated or scored by a CMS-approved 
proficiency testing program.
    (2) Any analyte, specialty or subspecialty assigned a proficiency 
testing score that does not reflect laboratory test performance (that 
is, when the proficiency testing program does not obtain the agreement 
required for scoring as specified in subpart I of this part, or the 
laboratory receives a zero score for nonparticipation, or late return of 
results).
    (c) At least twice annually, the laboratory must verify the accuracy 
of the following:
    (1) Any test or procedure it performs that is not included in 
subpart I of this part.
    (2) Any test or procedure listed in subpart I of this part for which 
compatible proficiency testing samples are not offered by a CMS-approved 
proficiency testing program.
    (d) All proficiency testing evaluation and verification activities 
must be documented.



Sec. 493.1239  Standard: General laboratory systems quality assessment.

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess, and, when 
indicated,

[[Page 701]]

correct problems identified in the general laboratory systems 
requirements specified at Sec. Sec. 493.1231 through 493.1236.
    (b) The general laboratory systems quality assessment must include a 
review of the effectiveness of corrective actions taken to resolve 
problems, revision of policies and procedures necessary to prevent 
recurrence of problems, and discussion of general laboratory systems 
quality assessment reviews with appropriate staff.
    (c) The laboratory must document all general laboratory systems 
quality assessment activities.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

                           Preanalytic Systems



Sec. 493.1240  Condition: Preanalytic systems.

    Each laboratory that performs nonwaived testing must meet the 
applicable preanalytic system(s) requirements in Sec. Sec. 493.1241 and 
493.1242, unless HHS approves a procedure, specified in Appendix C of 
the State Operations Manual (CMS Pub. 7), that provides equivalent 
quality testing. The laboratory must monitor and evaluate the overall 
quality of the preanalytic systems and correct identified problems as 
specified in Sec. 493.1249 for each specialty and subspecialty of 
testing performed.



Sec. 493.1241  Standard: Test request.

    (a) The laboratory must have a written or electronic request for 
patient testing from an authorized person.
    (b) The laboratory may accept oral requests for laboratory tests if 
it solicits a written or electronic authorization within 30 days of the 
oral request and maintains the authorization or documentation of its 
efforts to obtain the authorization.
    (c) The laboratory must ensure the test requisition solicits the 
following information:
    (1) The name and address or other suitable identifiers of the 
authorized person requesting the test and, if appropriate, the 
individual responsible for using the test results, or the name and 
address of the laboratory submitting the specimen, including, as 
applicable, a contact person to enable the reporting of imminently life 
threatening laboratory results or panic or alert values.
    (2) The patient's name or unique patient identifier.
    (3) The sex and age or date of birth of the patient.
    (4) The test(s) to be performed.
    (5) The source of the specimen, when appropriate.
    (6) The date and, if appropriate, time of specimen collection.
    (7) For Pap smears, the patient's last menstrual period, and 
indication of whether the patient had a previous abnormal report, 
treatment, or biopsy.
    (8) Any additional information relevant and necessary for a specific 
test to ensure accurate and timely testing and reporting of results, 
including interpretation, if applicable.
    (d) The patient's chart or medical record may be used as the test 
requisition or authorization but must be available to the laboratory at 
the time of testing and available to CMS or a CMS agent upon request.
    (e) If the laboratory transcribes or enters test requisition or 
authorization information into a record system or a laboratory 
information system, the laboratory must ensure the information is 
transcribed or entered accurately.



Sec. 493.1242  Standard: Specimen submission, handling, and referral.

    (a) The laboratory must establish and follow written policies and 
procedures for each of the following, if applicable:
    (1) Patient preparation.
    (2) Specimen collection.
    (3) Specimen labeling, including patient name or unique patient 
identifier and, when appropriate, specimen source.
    (4) Specimen storage and preservation.
    (5) Conditions for specimen transportation.
    (6) Specimen processing.
    (7) Specimen acceptability and rejection.
    (8) Specimen referral.
    (b) The laboratory must document the date and time it receives a 
specimen.

[[Page 702]]

    (c) The laboratory must refer a specimen for testing only to a CLIA-
certified laboratory or a laboratory meeting equivalent requirements as 
determined by CMS.
    (d) If the laboratory accepts a referral specimen, written 
instructions must be available to the laboratory's clients and must 
include, as appropriate, the information specified in paragraphs (a)(1) 
through (a)(7) of this section.



Sec. 493.1249  Standard: Preanalytic systems quality assessment.

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess, and when 
indicated, correct problems identified in the preanalytic systems 
specified at Sec. Sec. 493.1241 through 493.1242.
    (b) The preanalytic systems quality assessment must include a review 
of the effectiveness of corrective actions taken to resolve problems, 
revision of policies and procedures necessary to prevent recurrence of 
problems, and discussion of preanalytic systems quality assessment 
reviews with appropriate staff.
    (c) The laboratory must document all preanalytic systems quality 
assessment activities.

[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, 2003]

                            Analytic Systems



Sec. 493.1250  Condition: Analytic systems.

    Each laboratory that performs nonwaived testing must meet the 
applicable analytic systems requirements in Sec. Sec. 493.1251 through 
493.1283, unless HHS approves a procedure, specified in Appendix C of 
the State Operations Manual (CMS Pub. 7), that provides equivalent 
quality testing. The laboratory must monitor and evaluate the overall 
quality of the analytic systems and correct identified problems as 
specified in Sec. 493.1289 for each specialty and subspecialty of 
testing performed.



Sec. 493.1251  Standard: Procedure manual.

    (a) A written procedure manual for all tests, assays, and 
examinations performed by the laboratory must be available to, and 
followed by, laboratory personnel. Textbooks may supplement but not 
replace the laboratory's written procedures for testing or examining 
specimens.
    (b) The procedure manual must include the following when applicable 
to the test procedure:
    (1) Requirements for patient preparation; specimen collection, 
labeling, storage, preservation, transportation, processing, and 
referral; and criteria for specimen acceptability and rejection as 
described in Sec. 493.1242.
    (2) Microscopic examination, including the detection of inadequately 
prepared slides.
    (3) Step-by-step performance of the procedure, including test 
calculations and interpretation of results.
    (4) Preparation of slides, solutions, calibrators, controls, 
reagents, stains, and other materials used in testing.
    (5) Calibration and calibration verification procedures.
    (6) The reportable range for test results for the test system as 
established or verified in Sec. 493.1253.
    (7) Control procedures.
    (8) Corrective action to take when calibration or control results 
fail to meet the laboratory's criteria for acceptability.
    (9) Limitations in the test methodology, including interfering 
substances.
    (10) Reference intervals (normal values).
    (11) Imminently life-threatening test results, or panic or alert 
values.
    (12) Pertinent literature references.
    (13) The laboratory's system for entering results in the patient 
record and reporting patient results including, when appropriate, the 
protocol for reporting imminently life-threatening results, or panic, or 
alert values.
    (14) Description of the course of action to take if a test system 
becomes inoperable.
    (c) Manufacturer's test system instructions or operator manuals may 
be used, when applicable, to meet the requirements of paragraphs (b)(1) 
through (b)(12) of this section. Any of the items under paragraphs 
(b)(1) through (b)(12) of this section not provided by the manufacturer 
must be provided by the laboratory.

[[Page 703]]

    (d) Procedures and changes in procedures must be approved, signed, 
and dated by the current laboratory director before use.
    (e) The laboratory must maintain a copy of each procedure with the 
dates of initial use and discontinuance as described in Sec. 
493.1105(a)(2).

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1252  Standard: Test systems, equipment, instruments,
reagents, materials, and supplies.

    (a) Test systems must be selected by the laboratory. The testing 
must be performed following the manufacturer's instructions and in a 
manner that provides test results within the laboratory's stated 
performance specifications for each test system as determined under 
Sec. 493.1253.
    (b) The laboratory must define criteria for those conditions that 
are essential for proper storage of reagents and specimens, accurate and 
reliable test system operation, and test result reporting. The criteria 
must be consistent with the manufacturer's instructions, if provided. 
These conditions must be monitored and documented and, if applicable, 
include the following:
    (1) Water quality.
    (2) Temperature.
    (3) Humidity.
    (4) Protection of equipment and instruments from fluctuations and 
interruptions in electrical current that adversely affect patient test 
results and test reports.
    (c) Reagents, solutions, culture media, control materials, 
calibration materials, and other supplies, as appropriate, must be 
labeled to indicate the following:
    (1) Identity and when significant, titer, strength or concentration.
    (2) Storage requirements.
    (3) Preparation and expiration dates.
    (4) Other pertinent information required for proper use.
    (d) Reagents, solutions, culture media, control materials, 
calibration materials, and other supplies must not be used when they 
have exceeded their expiration date, have deteriorated, or are of 
substandard quality.
    (e) Components of reagent kits of different lot numbers must not be 
interchanged unless otherwise specified by the manufacturer.



Sec. 493.1253  Standard: Establishment and verification of performance
specifications.

    (a) Applicability. Laboratories are not required to verify or 
establish performance specifications for any test system used by the 
laboratory before April 24, 2003.
    (b)(1) Verification of performance specifications. Each laboratory 
that introduces an unmodified, FDA-cleared or approved test system must 
do the following before reporting patient test results:
    (i) Demonstrate that it can obtain performance specifications 
comparable to those established by the manufacturer for the following 
performance characteristics:
    (A) Accuracy.
    (B) Precision.
    (C) Reportable range of test results for the test system.
    (ii) Verify that the manufacturer's reference intervals (normal 
values) are appropriate for the laboratory's patient population.
    (2) Establishment of performance specifications. Each laboratory 
that modifies an FDA-cleared or approved test system, or introduces a 
test system not subject to FDA clearance or approval (including methods 
developed in-house and standardized methods such as text book 
procedures), or uses a test system in which performance specifications 
are not provided by the manufacturer must, before reporting patient test 
results, establish for each test system the performance specifications 
for the following performance characteristics, as applicable:
    (i) Accuracy.
    (ii) Precision.
    (iii) Analytical sensitivity.
    (iv) Analytical specificity to include interfering substances.
    (v) Reportable range of test results for the test system.
    (vi) Reference intervals (normal values).
    (vii) Any other performance characteristic required for test 
performance.

[[Page 704]]

    (3) Determination of calibration and control procedures. The 
laboratory must determine the test system's calibration procedures and 
control procedures based upon the performance specifications verified or 
established under paragraph (b)(1) or (b)(2) of this section.
    (c) Documentation. The laboratory must document all activities 
specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1254  Standard: Maintenance and function checks.

    (a) Unmodified manufacturer's equipment, instruments, or test 
systems. The laboratory must perform and document the following:
    (1) Maintenance as defined by the manufacturer and with at least the 
frequency specified by the manufacturer.
    (2) Function checks as defined by the manufacturer and with at least 
the frequency specified by the manufacturer. Function checks must be 
within the manufacturer's established limits before patient testing is 
conducted.
    (b) Equipment, instruments, or test systems developed in-house, 
commercially available and modified by the laboratory, or maintenance 
and function check protocols are not provided by the manufacturer. The 
laboratory must do the following:
    (1)(i) Establish a maintenance protocol that ensures equipment, 
instrument, and test system performance that is necessary for accurate 
and reliable test results and test result reporting.
    (ii) Perform and document the maintenance activities specified in 
paragraph (b)(1)(i) of this section.
    (2)(i) Define a function check protocol that ensures equipment, 
instrument, and test system performance that is necessary for accurate 
and reliable test results and test result reporting.
    (ii) Perform and document the function checks, including background 
or baseline checks, specified in paragraph (b)(2)(i) of this section. 
Function checks must be within the laboratory's established limits 
before patient testing is conducted.



Sec. 493.1255  Standard: Calibration and calibration verification
procedures.

    Calibration and calibration verification procedures are required to 
substantiate the continued accuracy of the test system throughout the 
laboratory's reportable range of test results for the test system. 
Unless otherwise specified in this subpart, for each applicable test 
system the laboratory must do the following:
    (a) Perform and document calibration procedures--
    (1) Following the manufacturer's test system instructions, using 
calibration materials provided or specified, and with at least the 
frequency recommended by the manufacturer;
    (2) Using the criteria verified or established by the laboratory as 
specified in Sec. 493.1253(b)(3)--
    (i) Using calibration materials appropriate for the test system and, 
if possible, traceable to a reference method or reference material of 
known value; and
    (ii) Including the number, type, and concentration of calibration 
materials, as well as acceptable limits for and the frequency of 
calibration; and
    (3) Whenever calibration verification fails to meet the laboratory's 
acceptable limits for calibration verification.
    (b) Perform and document calibration verification procedures--
    (1) Following the manufacturer's calibration verification 
instructions;
    (2) Using the criteria verified or established by the laboratory 
under Sec. 493.1253(b)(3)--
    (i) Including the number, type, and concentration of the materials, 
as well as acceptable limits for calibration verification; and
    (ii) Including at least a minimal (or zero) value, a mid-point 
value, and a maximum value near the upper limit of the range to verify 
the laboratory's reportable range of test results for the test system; 
and
    (3) At least once every 6 months and whenever any of the following 
occur:
    (i) A complete change of reagents for a procedure is introduced, 
unless the laboratory can demonstrate that changing reagent lot numbers 
does not affect the range used to report patient test results, and 
control values are not

[[Page 705]]

adversely affected by reagent lot number changes.
    (ii) There is major preventive maintenance or replacement of 
critical parts that may influence test performance.
    (iii) Control materials reflect an unusual trend or shift, or are 
outside of the laboratory's acceptable limits, and other means of 
assessing and correcting unacceptable control values fail to identify 
and correct the problem.
    (iv) The laboratory's established schedule for verifying the 
reportable range for patient test results requires more frequent 
calibration verification.



Sec. 493.1256  Standard: Control procedures.

    (a) For each test system, the laboratory is responsible for having 
control procedures that monitor the accuracy and precision of the 
complete analytic process.
    (b) The laboratory must establish the number, type, and frequency of 
testing control materials using, if applicable, the performance 
specifications verified or established by the laboratory as specified in 
Sec. 493.1253(b)(3).
    (c) The control procedures must--
    (1) Detect immediate errors that occur due to test system failure, 
adverse environmental conditions, and operator performance.
    (2) Monitor over time the accuracy and precision of test performance 
that may be influenced by changes in test system performance and 
environmental conditions, and variance in operator performance.
    (d) Unless CMS approves a procedure, specified in Appendix C of the 
State Operations Manual (CMS Pub. 7), that provides equivalent quality 
testing, the laboratory must--
    (1) Perform control procedures as defined in this section unless 
otherwise specified in the additional specialty and subspecialty 
requirements at Sec. Sec. 493.1261 through 493.1278.
    (2) For each test system, perform control procedures using the 
number and frequency specified by the manufacturer or established by the 
laboratory when they meet or exceed the requirements in paragraph (d)(3) 
of this section.
    (3) At least once each day patient specimens are assayed or examined 
perform the following for--
    (i) Each quantitative procedure, include two control materials of 
different concentrations;
    (ii) Each qualitative procedure, include a negative and positive 
control material;
    (iii) Test procedures producing graded or titered results, include a 
negative control material and a control material with graded or titered 
reactivity, respectively;
    (iv) Each test system that has an extraction phase, include two 
control materials, including one that is capable of detecting errors in 
the extraction process; and
    (v) Each molecular amplification procedure, include two control 
materials and, if reaction inhibition is a significant source of false 
negative results, a control material capable of detecting the 
inhibition.
    (4) For thin layer chromatography--
    (i) Spot each plate or card, as applicable, with a calibrator 
containing all known substances or drug groups, as appropriate, which 
are identified by thin layer chromatography and reported by the 
laboratory; and
    (ii) Include at least one control material on each plate or card, as 
applicable, which must be processed through each step of patient 
testing, including extraction processes.
    (5) For each electrophoretic procedure include, concurrent with 
patient specimens, at least one control material containing the 
substances being identified or measured.
    (6) Perform control material testing as specified in this paragraph 
before resuming patient testing when a complete change of reagents is 
introduced; major preventive maintenance is performed; or any critical 
part that may influence test performance is replaced.
    (7) Over time, rotate control material testing among all operators 
who perform the test.
    (8) Test control materials in the same manner as patient specimens.
    (9) When using calibration material as a control material, use 
calibration material from a different lot number than that used to 
establish a cut-off value or to calibrate the test system.

[[Page 706]]

    (10) Establish or verify the criteria for acceptability of all 
control materials.
    (i) When control materials providing quantitative results are used, 
statistical parameters (for example, mean and standard deviation) for 
each batch and lot number of control materials must be defined and 
available.
    (ii) The laboratory may use the stated value of a commercially 
assayed control material provided the stated value is for the 
methodology and instrumentation employed by the laboratory and is 
verified by the laboratory.
    (iii) Statistical parameters for unassayed control materials must be 
established over time by the laboratory through concurrent testing of 
control materials having previously determined statistical parameters.
    (e) For reagent, media, and supply checks, the laboratory must do 
the following:
    (1) Check each batch (prepared in-house), lot number (commercially 
prepared) and shipment of reagents, disks, stains, antisera, (except 
those specifically referenced in Sec. 493.1261(a)(3)) and 
identification systems (systems using two or more substrates or two or 
more reagents, or a combination) when prepared or opened for positive 
and negative reactivity, as well as graded reactivity, if applicable.
    (2) Each day of use (unless otherwise specified in this subpart), 
test staining materials for intended reactivity to ensure predictable 
staining characteristics. Control materials for both positive and 
negative reactivity must be included, as appropriate.
    (3) Check fluorescent and immunohistochemical stains for positive 
and negative reactivity each time of use.
    (4) Before, or concurrent with the initial use--
    (i) Check each batch of media for sterility if sterility is required 
for testing;
    (ii) Check each batch of media for its ability to support growth 
and, as appropriate, select or inhibit specific organisms or produce a 
biochemical response; and
    (iii) Document the physical characteristics of the media when 
compromised and report any deterioration in the media to the 
manufacturer.
    (5) Follow the manufacturer's specifications for using reagents, 
media, and supplies and be responsible for results.
    (f) Results of control materials must meet the laboratory's and, as 
applicable, the manufacturer's test system criteria for acceptability 
before reporting patient test results.
    (g) The laboratory must document all control procedures performed.
    (h) If control materials are not available, the laboratory must have 
an alternative mechanism to detect immediate errors and monitor test 
system performance over time. The performance of alternative control 
procedures must be documented.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1261  Standard: Bacteriology.

    (a) The laboratory must check the following for positive and 
negative reactivity using control organisms:
    (1) Each day of use for beta-lactamase methods other than Cefinase 
\TM\.
    (2) Each week of use for Gram stains.
    (3) When each batch (prepared in-house), lot number (commercially 
prepared), and shipment of antisera is prepared or opened, and once 
every 6 months thereafter.
    (b) For antimicrobial susceptibility tests, the laboratory must 
check each batch of media and each lot number and shipment of 
antimicrobial agent(s) before, or concurrent with, initial use, using 
approved control organisms.
    (1) Each day tests are performed, the laboratory must use the 
appropriate control organism(s) to check the procedure.
    (2) The laboratory's zone sizes or minimum inhibitory concentration 
for control organisms must be within established limits before reporting 
patient results.
    (c) The laboratory must document all control procedures performed, 
as specified in this section.



Sec. 493.1262  Standard: Mycobacteriology.

    (a) Each day of use, the laboratory must check all reagents or test 
procedures used for mycobacteria identification with at least one acid-
fast organism that produces a positive reaction

[[Page 707]]

and an acid-fast organism that produces a negative reaction.
    (b) For antimycobacterial susceptibility tests, the laboratory must 
check each batch of media and each lot number and shipment of 
antimycobacterial agent(s) before, or concurrent with, initial use, 
using an appropriate control organism(s).
    (1) The laboratory must establish limits for acceptable control 
results.
    (2) Each week tests are performed, the laboratory must use the 
appropriate control organism(s) to check the procedure.
    (3) The results for the control organism(s) must be within 
established limits before reporting patient results.
    (c) The laboratory must document all control procedures performed, 
as specified in this section.



Sec. 493.1263  Standard: Mycology.

    (a) The laboratory must check each batch (prepared in-house), lot 
number (commercially prepared), and shipment of lactophenol cotton blue 
when prepared or opened for intended reactivity with a control 
organism(s).
    (b) For antifungal susceptibility tests, the laboratory must check 
each batch of media and each lot number and shipment of antifungal 
agent(s) before, or concurrent with, initial use, using an appropriate 
control organism(s).
    (1) The laboratory must establish limits for acceptable control 
results.
    (2) Each day tests are performed, the laboratory must use the 
appropriate control organism(s) to check the procedure.
    (3) The results for the control organism(s) must be within 
established limits before reporting patient results.
    (c) The laboratory must document all control procedures performed, 
as specified in this section.



Sec. 493.1264  Standard: Parasitology.

    (a) The laboratory must have available a reference collection of 
slides or photographs and, if available, gross specimens for 
identification of parasites and use these references in the laboratory 
for appropriate comparison with diagnostic specimens.
    (b) The laboratory must calibrate and use the calibrated ocular 
micrometer for determining the size of ova and parasites, if size is a 
critical parameter.
    (c) Each month of use, the laboratory must check permanent stains 
using a fecal sample control material that will demonstrate staining 
characteristics.
    (d) The laboratory must document all control procedures performed, 
as specified in this section.



Sec. 493.1265  Standard: Virology.

    (a) When using cell culture to isolate or identify viruses, the 
laboratory must simultaneously incubate a cell substrate control or 
uninoculated cells as a negative control material.
    (b) The laboratory must document all control procedures performed, 
as specified in this section.



Sec. 493.1267  Standard: Routine chemistry.

    For blood gas analyses, the laboratory must perform the following:
    (a) Calibrate or verify calibration according to the manufacturer's 
specifications and with at least the frequency recommended by the 
manufacturer.
    (b) Test one sample of control material each 8 hours of testing 
using a combination of control materials that include both low and high 
values on each day of testing.
    (c) Test one sample of control material each time specimens are 
tested unless automated instrumentation internally verifies calibration 
at least every 30 minutes.
    (d) Document all control procedures performed, as specified in this 
section.



Sec. 493.1269  Standard: Hematology.

    (a) For manual cell counts performed using a hemocytometer--
    (1) One control material must be tested each 8 hours of operation; 
and
    (2) Patient specimens and control materials must be tested in 
duplicate.
    (b) For all nonmanual coagulation test systems, the laboratory must 
include two levels of control material each 8 hours of operation and 
each time a reagent is changed.
    (c) For manual coagulation tests--

[[Page 708]]

    (1) Each individual performing tests must test two levels of control 
materials before testing patient samples and each time a reagent is 
changed; and
    (2) Patient specimens and control materials must be tested in 
duplicate.
    (d) The laboratory must document all control procedures performed, 
as specified in this section.



Sec. 493.1271  Standard: Immunohematology.

    (a) Patient testing. (1) The laboratory must perform ABO grouping, 
D(Rho) typing, unexpected antibody detection, antibody identification, 
and compatibility testing by following the manufacturer's instructions, 
if provided, and as applicable, 21 CFR 606.151(a) through (e).
    (2) The laboratory must determine ABO group by concurrently testing 
unknown red cells with, at a minimum, anti-A and anti-B grouping 
reagents. For confirmation of ABO group, the unknown serum must be 
tested with known A1 and B red cells.
    (3) The laboratory must determine the D(Rho) type by testing unknown 
red cells with anti-D (anti-Rho) blood typing reagent.
    (b) Immunohematological testing and distribution of blood and blood 
products. Blood and blood product testing and distribution must comply 
with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 
640.5(a), (b), (c), and (e); and 640.11(b).
    (c) Blood and blood products storage. Blood and blood products must 
be stored under appropriate conditions that include an adequate 
temperature alarm system that is regularly inspected.
    (1) An audible alarm system must monitor proper blood and blood 
product storage temperature over a 24-hour period.
    (2) Inspections of the alarm system must be documented.
    (d) Retention of samples of transfused blood. According to the 
laboratory's established procedures, samples of each unit of transfused 
blood must be retained for further testing in the event of transfusion 
reactions. The laboratory must promptly dispose of blood not retained 
for further testing that has passed its expiration date.
    (e) Investigation of transfusion reactions. (1) According to its 
established procedures, the laboratory that performs compatibility 
testing, or issues blood or blood products, must promptly investigate 
all transfusion reactions occurring in facilities for which it has 
investigational responsibility and make recommendations to the medical 
staff regarding improvements in transfusion procedures.
    (2) The laboratory must document, as applicable, that all necessary 
remedial actions are taken to prevent recurrences of transfusion 
reactions and that all policies and procedures are reviewed to assure 
they are adequate to ensure the safety of individuals being transfused.
    (f) Documentation. The laboratory must document all control 
procedures performed, as specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1273  Standard: Histopathology.

    (a) As specified in Sec. 493.1256(e)(3), fluorescent and 
immunohistochemical stains must be checked for positive and negative 
reactivity each time of use. For all other differential or special 
stains, a control slide of known reactivity must be stained with each 
patient slide or group of patient slides. Reaction(s) of the control 
slide with each special stain must be documented.
    (b) The laboratory must retain stained slides, specimen blocks, and 
tissue remnants as specified in Sec. 493.1105. The remnants of tissue 
specimens must be maintained in a manner that ensures proper 
preservation of the tissue specimens until the portions submitted for 
microscopic examination have been examined and a diagnosis made by an 
individual qualified under Sec. 493.1449(b), (l), or (m).
    (c) An individual who has successfully completed a training program 
in neuromuscular pathology approved by HHS may examine and provide 
reports for neuromuscular pathology.
    (d) Tissue pathology reports must be signed by an individual 
qualified as specified in paragraph (b) or, as appropriate, paragraph 
(c) of this section. If a computer report is generated with an

[[Page 709]]

electronic signature, it must be authorized by the individual who 
performed the examination and made the diagnosis.
    (e) The laboratory must use acceptable terminology of a recognized 
system of disease nomenclature in reporting results.
    (f) The laboratory must document all control procedures performed, 
as specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1274  Standard: Cytology.

    (a) Cytology slide examination site. All cytology slide preparations 
must be evaluated on the premises of a laboratory certified to conduct 
testing in the subspecialty of cytology.
    (b) Staining. The laboratory must have available and follow written 
policies and procedures for each of the following, if applicable:
    (1) All gynecologic slide preparations must be stained using a 
Papanicolaou or modified Papanicolaou staining method.
    (2) Effective measures to prevent cross-contamination between 
gynecologic and nongynecologic specimens during the staining process 
must be used.
    (3) Nongynecologic specimens that have a high potential for cross-
contamination must be stained separately from other nongynecologic 
specimens, and the stains must be filtered or changed following 
staining.
    (c) Control procedures. The laboratory must establish and follow 
written policies and procedures for a program designed to detect errors 
in the performance of cytologic examinations and the reporting of 
results. The program must include the following:
    (1) A review of slides from at least 10 percent of the gynecologic 
cases interpreted by individuals qualified under Sec. 493.1469 or Sec. 
493.1483, to be negative for epithelial cell abnormalities and other 
malignant neoplasms (as defined in paragraph (e)(1) of this section).
    (i) The review must be performed by an individual who meets one of 
the following qualifications:
    (A) A technical supervisor qualified under Sec. 493.1449(b) or (k).
    (B) A cytology general supervisor qualified under Sec. 493.1469.
    (C) A cytotechnologist qualified under Sec. 493.1483 who has the 
experience specified in Sec. 493.1469(b)(2).
    (ii) Cases must be randomly selected from the total caseload and 
include negatives and those from patients or groups of patients that are 
identified as having a higher than average probability of developing 
cervical cancer based on available patient information.
    (iii) The review of those cases selected must be completed before 
reporting patient results.
    (2) Laboratory comparison of clinical information, when available, 
with cytology reports and comparison of all gynecologic cytology reports 
with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), 
adenocarcinoma, or other malignant neoplasms with the histopathology 
report, if available in the laboratory (either on-site or in storage), 
and determination of the causes of any discrepancies.
    (3) For each patient with a current HSIL, adenocarcinoma, or other 
malignant neoplasm, laboratory review of all normal or negative 
gynecologic specimens received within the previous 5 years, if available 
in the laboratory (either on-site or in storage). If significant 
discrepancies are found that will affect current patient care, the 
laboratory must notify the patient's physician and issue an amended 
report.
    (4) Records of initial examinations and all rescreening results must 
be documented.
    (5) An annual statistical laboratory evaluation of the number of--
    (i) Cytology cases examined;
    (ii) Specimens processed by specimen type;
    (iii) Patient cases reported by diagnosis (including the number 
reported as unsatisfactory for diagnostic interpretation);
    (iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or 
other malignant neoplasm for which histology results were available for 
comparison;
    (v) Gynecologic cases where cytology and histology are discrepant; 
and
    (vi) Gynecologic cases where any rescreen of a normal or negative 
specimen results in reclassification as low-

[[Page 710]]

grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or 
other malignant neoplasms.
    (6) An evaluation of the case reviews of each individual examining 
slides against the laboratory's overall statistical values, 
documentation of any discrepancies, including reasons for the deviation 
and, if appropriate, corrective actions taken.
    (d) Workload limits. The laboratory must establish and follow 
written policies and procedures that ensure the following:
    (1) The technical supervisor establishes a maximum workload limit 
for each individual who performs primary screening.
    (i) The workload limit is based on the individual's performance 
using evaluations of the following:
    (A) Review of 10 percent of the cases interpreted as negative for 
the conditions defined in paragraph (e)(1) of this section.
    (B) Comparison of the individual's interpretation with the technical 
supervisor's confirmation of patient smears specified in paragraphs 
(e)(1) and (e)(3) of this section.
    (ii) Each individual's workload limit is reassessed at least every 6 
months and adjusted when necessary.
    (2) The maximum number of slides examined by an individual in each 
24-hour period does not exceed 100 slides (one patient specimen per 
slide; gynecologic, nongynecologic, or both) irrespective of the site or 
laboratory. This limit represents an absolute maximum number of slides 
and must not be employed as an individual's performance target. In 
addition--
    (i) The maximum number of 100 slides is examined in no less than an 
8-hour workday;
    (ii) For the purposes of establishing workload limits for 
individuals examining slides in less than an 8-hour workday (includes 
full-time employees with duties other than slide examination and part-
time employees), a period of 8 hours is used to prorate the number of 
slides that may be examined. The formula--
[GRAPHIC] [TIFF OMITTED] TR24JA03.000


is used to determine maximum slide volume to be examined;
    (iii) Nongynecologic slide preparations made using liquid-based 
slide preparatory techniques that result in cell dispersion over one-
half or less of the total available slide may be counted as one-half 
slide; and
    (iv) Technical supervisors who perform primary screening are not 
required to include tissue pathology slides and previously examined 
cytology slides (gynecologic and nongynecologic) in the 100 slide 
workload limit.
    (3) The laboratory must maintain records of the total number of 
slides examined by each individual during each 24-hour period and the 
number of hours spent examining slides in the 24-hour period 
irrespective of the site or laboratory.
    (4) Records are available to document the workload limit for each 
individual.
    (e) Slide examination and reporting. The laboratory must establish 
and follow written policies and procedures that ensure the following:
    (1) A technical supervisor confirms each gynecologic slide 
preparation interpreted to exhibit reactive or reparative changes or any 
of the following epithelial cell abnormalities:
    (i) Squamous cell.
    (A) Atypical squamous cells of undetermined significance (ASC-US) or 
cannot exclude HSIL (ASC-H).
    (B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical 
intraepithelial neoplasia 1 (CIN 1).
    (C) HSIL-moderate and severe dysplasia, carcinoma in situ (CIS)/CIN 
2 and CIN 3 or with features suspicious for invasion.
    (D) Squamous cell carcinoma.
    (ii) Glandular cell.
    (A) Atypical cells not otherwise specified (NOS) or specified in 
comments (endocervical, endometrial, or glandular).
    (B) Atypical cells favor neoplastic (endocervical or glandular).
    (C) Endocervical adenocarcinoma in situ.
    (D) Adenocarcinoma endocervical, adenocarcinoma endometrial, 
adenocarcinoma extrauterine, and adenocarcinoma NOS.
    (iii) Other malignant neoplasms.

[[Page 711]]

    (2) The report of gynecologic slide preparations with conditions 
specified in paragraph (e)(1) of this section must be signed to reflect 
the technical supervisory review or, if a computer report is generated 
with signature, it must reflect an electronic signature authorized by 
the technical supervisor who performed the review.
    (3) All nongynecologic preparations are reviewed by a technical 
supervisor. The report must be signed to reflect technical supervisory 
review or, if a computer report is generated with signature, it must 
reflect an electronic signature authorized by the technical supervisor 
who performed the review.
    (4) Unsatisfactory specimens or slide preparations are identified 
and reported as unsatisfactory.
    (5) The report contains narrative descriptive nomenclature for all 
results.
    (6) Corrected reports issued by the laboratory indicate the basis 
for correction.
    (f) Record and slide retention. (1) The laboratory must retain all 
records and slide preparations as specified in Sec. 493.1105.
    (2) Slides may be loaned to proficiency testing programs in lieu of 
maintaining them for the required time period, provided the laboratory 
receives written acknowledgment of the receipt of slides by the 
proficiency testing program and maintains the acknowledgment to document 
the loan of these slides.
    (3) Documentation of slides loaned or referred for purposes other 
than proficiency testing must be maintained.
    (4) All slides must be retrievable upon request.
    (g) Automated and semi-automated screening devices. When performing 
evaluations using automated and semi-automated screening devices, the 
laboratory must follow manufacturer's instructions for preanalytic, 
analytic, and postanalytic phases of testing, as applicable, and meet 
the applicable requirements of this subpart K.
    (h) Documentation. The laboratory must document all control 
procedures performed, as specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1276  Standard: Clinical cytogenetics.

    (a) The laboratory must have policies and procedures for ensuring 
accurate and reliable patient specimen identification during the process 
of accessioning, cell preparation, photographing or other image 
reproduction technique, photographic printing, and reporting and storage 
of results, karyotypes, and photographs.
    (b) The laboratory must have records that document the following:
    (1) The media used, reactions observed, number of cells counted, 
number of cells karyotyped, number of chromosomes counted for each 
metaphase spread, and the quality of the banding.
    (2) The resolution is appropriate for the type of tissue or specimen 
and the type of study required based on the clinical information 
provided to the laboratory.
    (3) An adequate number of karyotypes are prepared for each patient.
    (c) Determination of sex must be performed by full chromosome 
analysis.
    (d) The laboratory report must include a summary and interpretation 
of the observations, number of cells counted and analyzed, and use the 
International System for Human Cytogenetic Nomenclature.
    (e) The laboratory must document all control procedures performed, 
as specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1278  Standard: Histocompatibility.

    (a) General. The laboratory must meet the following requirements:
    (1) An audible alarm system must be used to monitor the storage 
temperature of specimens (donor and beneficiary) and reagents. The 
laboratory must have an emergency plan for alternate storage.
    (2) All patient specimens must be easily retrievable.
    (3) Reagent typing sera inventory prepared in-house must indicate 
source, bleeding date and identification number, reagent specificity, 
and volume remaining.

[[Page 712]]

    (4) If the laboratory uses immunologic reagents (for example, 
antibodies, antibody-coated particles, or complement) to facilitate or 
enhance the isolation of lymphocytes, or lymphocyte subsets, the 
efficacy of the methods must be monitored with appropriate quality 
control procedures.
    (5) Participate in at least one national or regional cell exchange 
program, if available, or develop an exchange system with another 
laboratory in order to validate interlaboratory reproducibility.
    (b) HLA typing. The laboratory must do the following:
    (1) Use a technique(s) that is established to optimally define, as 
applicable, HLA Class I and II specificities.
    (2) HLA type all potential transplant beneficiaries at a level 
appropriate to support clinical transplant protocol and donor selection.
    (3) HLA type cells from organ donors referred to the laboratory.
    (4) Use HLA antigen terminology that conforms to the latest report 
of the World Health Organization (W.H.O.) Committee on Nomenclature. 
Potential new antigens not yet approved by this committee must have a 
designation that cannot be confused with W.H.O. terminology.
    (5) Have available and follow written criteria for the following:
    (i) The preparation of cells or cellular extracts (for example, 
solubilized antigens and nucleic acids), as applicable to the HLA typing 
technique(s) performed.
    (ii) Selecting typing reagents, whether prepared in-house or 
commercially.
    (iii) Ensuring that reagents used for typing are adequate to define 
all HLA-A, B and DR specificities that are officially recognized by the 
most recent W.H.O. Committee on Nomenclature and for which reagents are 
readily available.
    (iv) The assignment of HLA antigens.
    (v) When antigen redefinition and retyping are required.
    (6) Check each HLA typing by testing, at a minimum the following:
    (i) A positive control material.
    (ii) A negative control material in which, if applicable to the 
technique performed, cell viability at the end of incubation is 
sufficient to permit accurate interpretation of results. In assays in 
which cell viability is not required, the negative control result must 
be sufficiently different from the positive control result to permit 
accurate interpretation of results.
    (iii) Positive control materials for specific cell types when 
applicable (that is, T cells, B cells, and monocytes).
    (c) Disease-associated studies. The laboratory must check each 
typing for disease-associated HLA antigens using control materials to 
monitor the test components and each phase of the test system to ensure 
acceptable performance.
    (d) Antibody Screening. The laboratory must do the following:
    (1) Use a technique(s) that detects HLA-specific antibody with a 
specificity equivalent or superior to that of the basic complement-
dependent microlymphocytotoxicity assay.
    (2) Use a method that distinguishes antibodies to HLA Class II 
antigens from antibodies to Class I antigens to detect antibodies to HLA 
Class II antigens.
    (3) Use a panel that contains all the major HLA specificities and 
common splits. If the laboratory does not use commercial panels, it must 
maintain a list of individuals for fresh panel bleeding.
    (4) Make a reasonable attempt to have available monthly serum 
specimens for all potential transplant beneficiaries for periodic 
antibody screening and crossmatch.
    (5) Have available and follow a written policy consistent with 
clinical transplant protocols for the frequency of screening potential 
transplant beneficiary sera for preformed HLA-specific antibodies.
    (6) Check each antibody screening by testing, at a minimum the 
following:
    (i) A positive control material containing antibodies of the 
appropriate isotype for the assay.
    (ii) A negative control material.
    (7) As applicable, have available and follow written criteria and 
procedures for antibody identification to the level appropriate to 
support clinical transplant protocol.
    (e) Crossmatching. The laboratory must do the following:

[[Page 713]]

    (1) Use a technique(s) documented to have increased sensitivity in 
comparison with the basic complement-dependent microlymphocytotoxicity 
assay.
    (2) Have available and follow written criteria for the following:
    (i) Selecting appropriate patient serum samples for crossmatching.
    (ii) The preparation of donor cells or cellular extracts (for 
example, solubilized antigens and nucleic acids), as applicable to the 
crossmatch technique(s) performed.
    (3) Check each crossmatch and compatibility test for HLA Class II 
antigenic differences using control materials to monitor the test 
components and each phase of the test system to ensure acceptable 
performance.
    (f) Transplantation. Laboratories performing histocompatibility 
testing for transfusion and transplantation purposes must do the 
following:
    (1) Have available and follow written policies and protocols 
specifying the histocompatibility testing (that is, HLA typing, antibody 
screening, compatibility testing and crossmatching) to be performed for 
each type of cell, tissue or organ to be transfused or transplanted. The 
laboratory's policies must include, as applicable--
    (i) Testing protocols for cadaver donor, living, living-related, and 
combined organ and tissue transplants;
    (ii) Testing protocols for patients at high risk for allograft 
rejection; and
    (iii) The level of testing required to support clinical transplant 
protocols (for example, antigen or allele level).
    (2) For renal allotransplantation and combined organ and tissue 
transplants in which a kidney is to be transplanted, have available 
results of final crossmatches before the kidney is transplanted.
    (3) For nonrenal transplantation, if HLA testing and final 
crossmatches were not performed prospectively because of an emergency 
situation, the laboratory must document the circumstances, if known, 
under which the emergency transplant was performed, and records of the 
transplant must reflect any information provided to the laboratory by 
the patient's physician.
    (g) Documentation. The laboratory must document all control 
procedures performed, as specified in this section.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]



Sec. 493.1281  Standard: Comparison of test results.

    (a) If a laboratory performs the same test using different 
methodologies or instruments, or performs the same test at multiple 
testing sites, the laboratory must have a system that twice a year 
evaluates and defines the relationship between test results using the 
different methodologies, instruments, or testing sites.
    (b) The laboratory must have a system to identify and assess patient 
test results that appear inconsistent with the following relevant 
criteria, when available:
    (1) Patient age.
    (2) Sex.
    (3) Diagnosis or pertinent clinical data.
    (4) Distribution of patient test results.
    (5) Relationship with other test parameters.
    (c) The laboratory must document all test result comparison 
activities.



Sec. 493.1282  Standard: Corrective actions.

    (a) Corrective action policies and procedures must be available and 
followed as necessary to maintain the laboratory's operation for testing 
patient specimens in a manner that ensures accurate and reliable patient 
test results and reports.
    (b) The laboratory must document all corrective actions taken, 
including actions taken when any of the following occur:
    (1) Test systems do not meet the laboratory's verified or 
established performance specifications, as determined in Sec. 
493.1253(b), which include but are not limited to--
    (i) Equipment or methodologies that perform outside of established 
operating parameters or performance specifications;
    (ii) Patient test values that are outside of the laboratory's 
reportable range of test results for the test system; and

[[Page 714]]

    (iii) When the laboratory determines that the reference intervals 
(normal values) for a test procedure are inappropriate for the 
laboratory's patient population.
    (2) Results of control or calibration materials, or both, fail to 
meet the laboratory's established criteria for acceptability. All 
patient test results obtained in the unacceptable test run and since the 
last acceptable test run must be evaluated to determine if patient test 
results have been adversely affected. The laboratory must take the 
corrective action necessary to ensure the reporting of accurate and 
reliable patient test results.
    (3) The criteria for proper storage of reagents and specimens, as 
specified under Sec. 493.1252(b), are not met.



Sec. 493.1283  Standard: Test records.

    (a) The laboratory must maintain an information or record system 
that includes the following:
    (1) The positive identification of the specimen.
    (2) The date and time of specimen receipt into the laboratory.
    (3) The condition and disposition of specimens that do not meet the 
laboratory's criteria for specimen acceptability.
    (4) The records and dates of all specimen testing, including the 
identity of the personnel who performed the test(s).
    (b) Records of patient testing including, if applicable, instrument 
printouts, must be retained.



Sec. 493.1289  Standard: Analytic systems quality assessment.

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess, and when 
indicated, correct problems identified in the analytic systems specified 
in Sec. Sec. 493.1251 through 493.1283.
    (b) The analytic systems quality assessment must include a review of 
the effectiveness of corrective actions taken to resolve problems, 
revision of policies and procedures necessary to prevent recurrence of 
problems, and discussion of analytic systems quality assessment reviews 
with appropriate staff.
    (c) The laboratory must document all analytic systems quality 
assessment activities.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

                          Postanalytic Systems



Sec. 493.1290  Condition: Postanalytic systems.

    Each laboratory that performs nonwaived testing must meet the 
applicable postanalytic systems requirements in Sec. 493.1291 unless 
HHS approves a procedure, specified in Appendix C of the State 
Operations Manual (CMS Pub. 7) that provides equivalent quality testing. 
The laboratory must monitor and evaluate the overall quality of the 
postanalytic systems and correct identified problems as specified in 
Sec. 493.1299 for each specialty and subspecialty of testing performed.



Sec. 493.1291  Standard: Test report.

    (a) The laboratory must have an adequate manual or electronic 
system(s) in place to ensure test results and other patient-specific 
data are accurately and reliably sent from the point of data entry 
(whether interfaced or entered manually) to final report destination, in 
a timely manner. This includes the following:
    (1) Results reported from calculated data.
    (2) Results and patient-specific data electronically reported to 
network or interfaced systems.
    (3) Manually transcribed or electronically transmitted results and 
patient-specific information reported directly or upon receipt from 
outside referral laboratories, satellite or point-of-care testing 
locations.
    (b) Test report information maintained as part of the patient's 
chart or medical record must be readily available to the laboratory and 
to CMS or a CMS agent upon request.
    (c) The test report must indicate the following:
    (1) For positive patient identification, either the patient's name 
and identification number, or a unique patient identifier and 
identification number.

[[Page 715]]

    (2) The name and address of the laboratory location where the test 
was performed.
    (3) The test report date.
    (4) The test performed.
    (5) Specimen source, when appropriate.
    (6) The test result and, if applicable, the units of measurement or 
interpretation, or both.
    (7) Any information regarding the condition and disposition of 
specimens that do not meet the laboratory's criteria for acceptability.
    (d) Pertinent ``reference intervals'' or ``normal'' values, as 
determined by the laboratory performing the tests, must be available to 
the authorized person who ordered the tests and, if applicable, the 
individual responsible for using the test results.
    (e) The laboratory must, upon request, make available to clients a 
list of test methods employed by the laboratory and, as applicable, the 
performance specifications established or verified as specified in Sec. 
493.1253. In addition, information that may affect the interpretation of 
test results, for example test interferences, must be provided upon 
request. Pertinent updates on testing information must be provided to 
clients whenever changes occur that affect the test results or 
interpretation of test results.
    (f) Except as provided in Sec. 493.1291(l), test results must be 
released only to authorized persons and, if applicable, the persons 
responsible for using the test results and the laboratory that initially 
requested the test.
    (g) The laboratory must immediately alert the individual or entity 
requesting the test and, if applicable, the individual responsible for 
using the test results when any test result indicates an imminently 
life-threatening condition, or panic or alert values.
    (h) When the laboratory cannot report patient test results within 
its established time frames, the laboratory must determine, based on the 
urgency of the patient test(s) requested, the need to notify the 
appropriate individual(s) of the delayed testing.
    (i) If a laboratory refers patient specimens for testing--
    (1) The referring laboratory must not revise results or information 
directly related to the interpretation of results provided by the 
testing laboratory;
    (2) The referring laboratory may permit each testing laboratory to 
send the test result directly to the authorized person who initially 
requested the test. The referring laboratory must retain or be able to 
produce an exact duplicate of each testing laboratory's report; and
    (3) The authorized person who orders a test must be notified by the 
referring laboratory of the name and address of each laboratory location 
where the test was performed.
    (j) All test reports or records of the information on the test 
reports must be maintained by the laboratory in a manner that permits 
ready identification and timely accessibility.
    (k) When errors in the reported patient test results are detected, 
the laboratory must do the following:
    (1) Promptly notify the authorized person ordering the test and, if 
applicable, the individual using the test results of reporting errors.
    (2) Issue corrected reports promptly to the authorized person 
ordering the test and, if applicable, the individual using the test 
results.
    (3) Maintain duplicates of the original report, as well as the 
corrected report.
    (l) Upon request by a patient (or the patient's personal 
representative), the laboratory may provide patients, their personal 
representatives, and those persons specified under 45 CFR 
164.524(c)(3)(ii), as applicable, with access to completed test reports 
that, using the laboratory's authentication process, can be identified 
as belonging to that patient.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003, as amended at 79 
FR 7316, Feb. 6, 2014]



Sec. 493.1299  Standard: Postanalytic systems quality assessment.

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess and, when 
indicated, correct problems identified in the postanalytic systems 
specified in Sec. 493.1291.
    (b) The postanalytic systems quality assessment must include a 
review of the effectiveness of corrective actions

[[Page 716]]

taken to resolve problems, revision of policies and procedures necessary 
to prevent recurrence of problems, and discussion of postanalytic 
systems quality assessment reviews with appropriate staff.
    (c) The laboratory must document all postanalytic systems quality 
assessment activities.

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

Subpart L [Reserved]



                Subpart M_Personnel for Nonwaived Testing

    Source: 57 FR 7172, Feb. 28, 1992, unless otherwise noted.



Sec. 493.1351  General.

    This subpart consists of the personnel requirements that must be met 
by laboratories performing moderate complexity testing, PPM procedures, 
high complexity testing, or any combination of these tests.

[60 FR 20049, Apr. 24, 1995]

 Laboratories Performing Provider-Performed Microscopy (PPM) Procedures

    Source: 60 FR 20049, Apr. 24, 1995, unless otherwise noted.



Sec. 493.1353  Scope.

    In accordance with Sec. 493.19(b), the moderate complexity 
procedures specified as PPM procedures are considered such only when 
personally performed by a health care provider during a patient visit in 
the context of a physical examination. PPM procedures are subject to the 
personnel requirements in Sec. Sec. 493.1355 through 493.1365.



Sec. 493.1355  Condition: Laboratories performing PPM procedures; 
laboratory director.

    The laboratory must have a director who meets the qualification 
requirements of Sec. 493.1357 and provides overall management and 
direction in accordance with Sec. 493.1359.



Sec. 493.1357  Standard; laboratory director qualifications.

    The laboratory director must be qualified to manage and direct the 
laboratory personnel and the performance of PPM procedures as specified 
in Sec. 493.19(c) and must be eligible to be an operator of a 
laboratory within the requirements of subpart R of this part.
    (a) The laboratory director must possess a current license as a 
laboratory director issued by the State in which the laboratory is 
located, if the licensing is required.
    (b) The laboratory director must meet one of the following 
requirements:
    (1) Be a physician, as defined in Sec. 493.2.
    (2) Be a midlevel practitioner, as defined in Sec. 493.2, 
authorized by a State to practice independently in the State in which 
the laboratory is located.
    (3) Be a dentist, as defined in Sec. 493.2.



Sec. 493.1359  Standard; PPM laboratory director responsibilities.

    The laboratory director is responsible for the overall operation and 
administration of the laboratory, including the prompt, accurate, and 
proficient reporting of test results. The laboratory director must--
    (a) Direct no more than five laboratories; and
    (b) Ensure that any procedure listed under Sec. 493.19(c)--
    (1) Is personally performed by an individual who meets the 
qualification requirements in Sec. 493.1363; and
    (2) Is performed in accordance with applicable requirements in 
subparts H, J, K, and M of this part.

[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3713, Jan. 24, 2003; 68 
FR 50724, Aug. 22, 2003]



Sec. 493.1361  Condition: Laboratories performing PPM procedures;
testing personnel.

    The laboratory must have a sufficient number of individuals who meet 
the qualification requirements of Sec. 493.1363 to perform the 
functions specified in Sec. 493.1365 for the volume and complexity of 
testing performed.

[[Page 717]]



Sec. 493.1363  Standard: PPM testing personnel qualifications.

    Each individual performing PPM procedures must--
    (a) Possess a current license issued by the State in which the 
laboratory is located if the licensing is required; and
    (b) Meet one of the following requirements:
    (1) Be a physician, as defined in Sec. 493.2.
    (2) Be a midlevel practitioner, as defined in Sec. 493.2, under the 
supervision of a physician or in independent practice if authorized by 
the State in which the laboratory is located.
    (3) Be a dentist as defined in Sec. 493.2 of this part.



Sec. 493.1365  Standard; PPM testing personnel responsibilities.

    The testing personnel are responsible for specimen processing, test 
performance, and for reporting test results. Any PPM procedure must be--
    (a) Personally performed by one of the following practitioners:
    (1) A physician during the patient's visit on a specimen obtained 
from his or her own patient or from a patient of a group medical 
practice of which the physician is a member or employee.
    (2) A midlevel practitioner, under the supervision of a physician or 
in independent practice if authorized by the State in which the 
laboratory is located, during the patient's visit on a specimen obtained 
from his or her own patient or from the patient of a clinic, group 
medical practice, or other health care provider, in which the midlevel 
practitioner is a member or an employee.
    (3) A dentist during the patient's visit on a specimen obtained from 
his or her own patient or from a patient of a group dental practice of 
which the dentist is a member or an employee; and
    (b) Performed using a microscope limited to a brightfield or a 
phase/contrast microscope.

           Laboratories Performing Moderate Complexity Testing



Sec. 493.1403  Condition: Laboratories performing moderate complexity
testing; laboratory director.

    The laboratory must have a director who meets the qualification 
requirements of Sec. 493.1405 of this subpart and provides overall 
management and direction in accordance with Sec. 493.1407 of this 
subpart.



Sec. 493.1405  Standard; Laboratory director qualifications.

    The laboratory director must be qualified to manage and direct the 
laboratory personnel and the performance of moderate complexity tests 
and must be eligible to be an operator of a laboratory within the 
requirements of subpart R of this part.
    (a) The laboratory director must possess a current license as a 
laboratory director issued by the State in which the laboratory is 
located, if such licensing is required; and
    (b) The laboratory director must--
    (1) (i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in anatomic or clinical pathology, or both, by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology or possess qualifications that are equivalent to those 
required for such certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have had laboratory training or experience consisting of:
    (A) At least one year directing or supervising non-waived laboratory 
testing; or
    (B) Beginning September 1, 1993, have at least 20 continuing medical 
education credit hours in laboratory practice commensurate with the 
director responsibilities defined in Sec. 493.1407; or
    (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of 
this section obtained during medical residency. (For example, physicians 
certified either in hematology or hematology and

[[Page 718]]

medical oncology by the American Board of Internal Medicine); or
    (3) Hold an earned doctoral degree in a chemical, physical, 
biological, or clinical laboratory science from an accredited 
institution; and
    (i) Be certified by the American Board of Medical Microbiology, the 
American Board of Clinical Chemistry, the American Board of Bioanalysis, 
or the American Board of Medical Laboratory Immunology; or
    (ii) Have had at least one year experience directing or supervising 
non-waived laboratory testing;
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution;
    (ii) Have at least one year of laboratory training or experience, or 
both in non-waived testing; and
    (iii) In addition, have at least one year of supervisory laboratory 
experience in non-waived testing; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical, or 
biological science or medical technology from an accredited institution;
    (ii) Have at least 2 years of laboratory training or experience, or 
both in non-waived testing; and
    (iii) In addition, have at least 2 years of supervisory laboratory 
experience in non-waived testing;
    (6) Be serving as a laboratory director and must have previously 
qualified or could have qualified as a laboratory director under Sec. 
493.1406; or
    (7) On or before February 28, 1992, qualified under State law to 
direct a laboratory in the State in which the laboratory is located.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5233, Jan. 19, 1993]



Sec. 493.1406  Standard; Laboratory director qualifications on or 
before February 28, 1992.

    The laboratory director must be qualified to manage and direct the 
laboratory personnel and test performance.
    (a) The laboratory director must possess a current license as a 
laboratory director issued by the State, if such licensing exists; and
    (b) The laboratory director must:
    (1) Be a physician certified in anatomical or clinical pathology (or 
both) by the American Board of Pathology or the American Osteopathic 
Board of Pathology or possess qualifications that are equivalent to 
those required for such certification;
    (2) Be a physician who:
    (i) Is certified by the American Board of Pathology or the American 
Osteopathic Board of Pathology in at least one of the laboratory 
specialties; or
    (ii) Is certified by the American Board of Medical Microbiology, the 
American Board of Clinical Chemistry, the American Board of Bioanalysis, 
or other national accrediting board in one of the laboratory 
specialties; or
    (iii) Is certified by the American Society of Cytology to practice 
cytopathology or possesses qualifications that are equivalent to those 
required for such certification; or
    (iv) Subsequent to graduation, has had 4 or more years of full-time 
general laboratory training and experience of which at least 2 years 
were spent acquiring proficiency in one of the laboratory specialties;
    (3) For the subspecialty of oral pathology only, be certified by the 
American Board of Oral Pathology, American Board of Pathology or the 
American Osteopathic Board of Pathology or possesses qualifications that 
are equivalent to those required for certification;
    (4) Hold an earned doctoral degree from an accredited institution 
with a chemical, physical, or biological science as a major subject and
    (i) Is certified by the American Board of Medical Microbiology, the 
American Board of Clinical Chemistry, the American Board of Bioanalysis, 
or other national accrediting board acceptable to HHS in one of the 
laboratory specialties; or
    (ii) Subsequent to graduation, has had 4 or more years of full-time 
general laboratory training and experience of which at least 2 years 
were spent acquiring proficiency in one of the laboratory specialties;
    (5) With respect to individuals first qualifying before July 1, 
1971, have been responsible for the direction of a laboratory for 12 
months between July

[[Page 719]]

1, 1961, and January 1, 1968, and, in addition, either:
    (i) Was a physician and subsequent to graduation had at least 4 
years of pertinent full-time laboratory experience;
    (ii) Held a master's degree from an accredited institution with a 
chemical, physical, or biological science as a major subject and 
subsequent to graduation had at least 4 years of pertinent full-time 
laboratory experience;
    (iii) Held a bachelor's degree from an accredited institution with a 
chemical, physical, or biological science as a major subject and 
subsequent to graduation had at least 6 years of pertinent full-time 
laboratory experience; or
    (iv) Achieved a satisfactory grade through an examination conducted 
by or under the sponsorship of the U.S. Public Health Service on or 
before July 1, 1970; or
    (6) Qualify under State law to direct the laboratory in the State in 
which the laboratory is located.

    Note: The January 1, 1968 date for meeting the 12 months' laboratory 
direction requirement in paragraph (b)(5) of this section may be 
extended 1 year for each year of full-time laboratory experience 
obtained before January 1, 1958 required by State law for a laboratory 
director license. An exception to the July 1, 1971 qualifying date in 
paragraph (b)(5) of this section was made provided that the individual 
requested qualification approval by October 21, 1975 and had been 
employed in a laboratory for at least 3 years of the 5 years preceding 
the date of submission of his qualifications.

[58 FR 5233, Jan. 19, 1993]



Sec. 493.1407  Standard; Laboratory director responsibilities.

    The laboratory director is responsible for the overall operation and 
administration of the laboratory, including the employment of personnel 
who are competent to perform test procedures, and record and report test 
results promptly, accurate, and proficiently and for assuring compliance 
with the applicable regulations.
    (a) The laboratory director, if qualified, may perform the duties of 
the technical consultant, clinical consultant, and testing personnel, or 
delegate these responsibilities to personnel meeting the qualifications 
of Sec. Sec. 493.1409, 493.1415, and 493.1421, respectively.
    (b) If the laboratory director reapportions performance of his or 
her responsibilities, he or she remains responsible for ensuring that 
all duties are properly performed.
    (c) The laboratory director must be accessible to the laboratory to 
provide onsite, telephone or electronic consultation as needed.
    (d) Each individual may direct no more than five laboratories.
    (e) The laboratory director must--
    (1) Ensure that testing systems developed and used for each of the 
tests performed in the laboratory provide quality laboratory services 
for all aspects of test performance, which includes the preanalytic, 
analytic, and postanalytic phases of testing;
    (2) Ensure that the physical plant and environmental conditions of 
the laboratory are appropriate for the testing performed and provide a 
safe environment in which employees are protected from physical, 
chemical, and biological hazards;
    (3) Ensure that--
    (i) The test methodologies selected have the capability of providing 
the quality of results required for patient care;
    (ii) Verification procedures used are adequate to determine the 
accuracy, precision, and other pertinent performance characteristics of 
the method; and
    (iii) Laboratory personnel are performing the test methods as 
required for accurate and reliable results;
    (4) Ensure that the laboratory is enrolled in an HHS approved 
proficiency testing program for the testing performed and that--
    (i) The proficiency testing samples are tested as required under 
subpart H of this part;
    (ii) The results are returned within the timeframes established by 
the proficiency testing program;
    (iii) All proficiency testing reports received are reviewed by the 
appropriate staff to evaluate the laboratory's performance and to 
identify any problems that require corrective action; and
    (iv) An approved corrective action plan is followed when any 
proficiency testing results are found to be unacceptable or 
unsatisfactory;

[[Page 720]]

    (5) Ensure that the quality control and quality assessment programs 
are established and maintained to assure the quality of laboratory 
services provided and to identify failures in quality as they occur;
    (6) Ensure the establishment and maintenance of acceptable levels of 
analytical performance for each test system;
    (7) Ensure that all necessary remedial actions are taken and 
documented whenever significant deviations from the laboratory's 
established performance specifications are identified, and that patient 
test results are reported only when the system is functioning properly;
    (8) Ensure that reports of test results include pertinent 
information required for interpretation;
    (9) Ensure that consultation is available to the laboratory's 
clients on matters relating to the quality of the test results reported 
and their interpretation concerning specific patient conditions;
    (10) Employ a sufficient number of laboratory personnel with the 
appropriate education and either experience or training to provide 
appropriate consultation, properly supervise and accurately perform 
tests and report test results in accordance with the personnel 
responsibilities described in this subpart;
    (11) Ensure that prior to testing patients' specimens, all personnel 
have the appropriate education and experience, receive the appropriate 
training for the type and complexity of the services offered, and have 
demonstrated that they can perform all testing operations reliably to 
provide and report accurate results;
    (12) Ensure that policies and procedures are established for 
monitoring individuals who conduct preanalytical, analytical, and 
postanalytical phases of testing to assure that they are competent and 
maintain their competency to process specimens, perform test procedures 
and report test results promptly and proficiently, and whenever 
necessary, identify needs for remedial training or continuing education 
to improve skills;
    (13) Ensure that an approved procedure manual is available to all 
personnel responsible for any aspect of the testing process; and
    (14) Specify, in writing, the responsibilities and duties of each 
consultant and each person, engaged in the performance of the 
preanalytic, analytic, and postanalytic phases of testing, that 
identifies which examinations and procedures each individual is 
authorized to perform, whether supervision is required for specimen 
processing, test performance or results reporting, and whether 
consultant or director review is required prior to reporting patient 
test results.

[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3713, Jan. 24, 2003]



Sec. 493.1409  Condition: Laboratories performing moderate complexity
testing; technical consultant.

    The laboratory must have a technical consultant who meets the 
qualification requirements of Sec. 493.1411 of this subpart and 
provides technical oversight in accordance with Sec. 493.1413 of this 
subpart.



Sec. 493.1411  Standard; Technical consultant qualifications.

    The laboratory must employ one or more individuals who are qualified 
by education and either training or experience to provide technical 
consultation for each of the specialties and subspecialties of service 
in which the laboratory performs moderate complexity tests or 
procedures. The director of a laboratory performing moderate complexity 
testing may function as the technical consultant provided he or she 
meets the qualifications specified in this section.
    (a) The technical consultant must possess a current license issued 
by the State in which the laboratory is located, if such licensing is 
required.
    (b) The technical consultant must--
    (1) (i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in anatomic or clinical pathology, or both, by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology or possess qualifications that are equivalent to those 
required for such certification; or

[[Page 721]]

    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least one year of laboratory training or experience, or 
both in non-waived testing, in the designated specialty or subspecialty 
areas of service for which the technical consultant is responsible (for 
example, physicians certified either in hematology or hematology and 
medical oncology by the American Board of Internal Medicine are 
qualified to serve as the technical consultant in hematology); or
    (3)(i) Hold an earned doctoral or master's degree in a chemical, 
physical, biological or clinical laboratory science or medical 
technology from an accredited institution; and
    (ii) Have at least one year of laboratory training or experience, or 
both in non-waived testing, in the designated specialty or subspecialty 
areas of service for which the technical consultant is responsible; or
    (4)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 2 years of laboratory training or experience, or 
both in non-waived testing, in the designated specialty or subspecialty 
areas of service for which the technical consultant is responsible.

    Note: The technical consultant requirements for ``laboratory 
training or experience, or both'' in each specialty or subspecialty may 
be acquired concurrently in more than one of the specialties or 
subspecialties of service, excluding waived tests. For example, an 
individual who has a bachelor's degree in biology and additionally has 
documentation of 2 years of work experience performing tests of moderate 
complexity in all specialties and subspecialties of service, would be 
qualified as a technical consultant in a laboratory performing moderate 
complexity testing in all specialties and subspecialties of service.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]



Sec. 493.1413  Standard; Technical consultant responsibilities.

    The technical consultant is responsible for the technical and 
scientific oversight of the laboratory. The technical consultant is not 
required to be onsite at all times testing is performed; however, he or 
she must be available to the laboratory on an as needed basis to provide 
consultation, as specified in paragraph (a) of this section.
    (a) The technical consultant must be accessible to the laboratory to 
provide on-site, telephone, or electronic consultation; and
    (b) The technical consultant is responsible for--
    (1) Selection of test methodology appropriate for the clinical use 
of the test results;
    (2) Verification of the test procedures performed and the 
establishment of the laboratory's test performance characteristics, 
including the precision and accuracy of each test and test system;
    (3) Enrollment and participation in an HHS approved proficiency 
testing program commensurate with the services offered;
    (4) Establishing a quality control program appropriate for the 
testing performed and establishing the parameters for acceptable levels 
of analytic performance and ensuring that these levels are maintained 
throughout the entire testing process from the initial receipt of the 
specimen, through sample analysis and reporting of test results;
    (5) Resolving technical problems and ensuring that remedial actions 
are taken whenever test systems deviate from the laboratory's 
established performance specifications;
    (6) Ensuring that patient test results are not reported until all 
corrective actions have been taken and the test system is functioning 
properly;
    (7) Identifying training needs and assuring that each individual 
performing tests receives regular in-service training and education 
appropriate for the type and complexity of the laboratory services 
performed;
    (8) Evaluating the competency of all testing personnel and assuring 
that the staff maintain their competency to perform test procedures and 
report test results promptly, accurately and proficiently. The 
procedures for evaluation of the competency of the staff must include, 
but are not limited to--

[[Page 722]]

    (i) Direct observations of routine patient test performance, 
including patient preparation, if applicable, specimen handling, 
processing and testing;
    (ii) Monitoring the recording and reporting of test results;
    (iii) Review of intermediate test results or worksheets, quality 
control records, proficiency testing results, and preventive maintenance 
records;
    (iv) Direct observation of performance of instrument maintenance and 
function checks;
    (v) Assessment of test performance through testing previously 
analyzed specimens, internal blind testing samples or external 
proficiency testing samples; and
    (vi) Assessment of problem solving skills; and
    (9) Evaluating and documenting the performance of individuals 
responsible for moderate complexity testing at least semiannually during 
the first year the individual tests patient specimens. Thereafter, 
evaluations must be performed at least annually unless test methodology 
or instrumentation changes, in which case, prior to reporting patient 
test results, the individual's performance must be reevaluated to 
include the use of the new test methodology or instrumentation.



Sec. 493.1415  Condition: Laboratories performing moderate complexity
testing; clinical consultant.

    The laboratory must have a clinical consultant who meets the 
qualification requirements of Sec. 493.1417 of this part and provides 
clinical consultation in accordance with Sec. 493.1419 of this part.



Sec. 493.1417  Standard; Clinical consultant qualifications.

    The clinical consultant must be qualified to consult with and render 
opinions to the laboratory's clients concerning the diagnosis, treatment 
and management of patient care. The clinical consultant must--
    (a) Be qualified as a laboratory director under Sec. 493.1405(b) 
(1), (2), or (3)(i); or
    (b) Be a doctor of medicine, doctor of osteopathy or doctor of 
podiatric medicine and possess a license to practice medicine, 
osteopathy or podiatry in the State in which the laboratory is located.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]



Sec. 493.1419  Standard; Clinical consultant responsibilities.

    The clinical consultant provides consultation regarding the 
appropriateness of the testing ordered and interpretation of test 
results. The clinical consultant must--
    (a) Be available to provide clinical consultation to the 
laboratory's clients;
    (b) Be available to assist the laboratory's clients in ensuring that 
appropriate tests are ordered to meet the clinical expectations;
    (c) Ensure that reports of test results include pertinent 
information required for specific patient interpretation; and
    (d) Ensure that consultation is available and communicated to the 
laboratory's clients on matters related to the quality of the test 
results reported and their interpretation concerning specific patient 
conditions.



Sec. 493.1421  Condition: Laboratories performing moderate complexity
testing; testing personnel.

    The laboratory must have a sufficient number of individuals who meet 
the qualification requirements of Sec. 493.1423, to perform the 
functions specified in Sec. 493.1425 for the volume and complexity of 
tests performed.



Sec. 493.1423  Standard; Testing personnel qualifications.

    Each individual performing moderate complexity testing must--
    (a) Possess a current license issued by the State in which the 
laboratory is located, if such licensing is required; and
    (b) Meet one of the following requirements:
    (1) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located or have earned a doctoral, master's, or bachelor's degree in a 
chemical, physical, biological or clinical laboratory science, or 
medical technology from an accredited institution; or

[[Page 723]]

    (2) Have earned an associate degree in a chemical, physical or 
biological science or medical laboratory technology from an accredited 
institution; or
    (3) Be a high school graduate or equivalent and have successfully 
completed an official military medical laboratory procedures course of 
at least 50 weeks duration and have held the military enlisted 
occupational specialty of Medical Laboratory Specialist (Laboratory 
Technician); or
    (4)(i) Have earned a high school diploma or equivalent; and
    (ii) Have documentation of training appropriate for the testing 
performed prior to analyzing patient specimens. Such training must 
ensure that the individual has--
    (A) The skills required for proper specimen collection, including 
patient preparation, if applicable, labeling, handling, preservation or 
fixation, processing or preparation, transportation and storage of 
specimens;
    (B) The skills required for implementing all standard laboratory 
procedures;
    (C) The skills required for performing each test method and for 
proper instrument use;
    (D) The skills required for performing preventive maintenance, 
troubleshooting and calibration procedures related to each test 
performed;
    (E) A working knowledge of reagent stability and storage;
    (F) The skills required to implement the quality control policies 
and procedures of the laboratory;
    (G) An awareness of the factors that influence test results; and
    (H) The skills required to assess and verify the validity of patient 
test results through the evaluation of quality control sample values 
prior to reporting patient test results.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]



Sec. 493.1425  Standard; Testing personnel responsibilities.

    The testing personnel are responsible for specimen processing, test 
performance, and for reporting test results.
    (a) Each individual performs only those moderate complexity tests 
that are authorized by the laboratory director and require a degree of 
skill commensurate with the individual's education, training or 
experience, and technical abilities.
    (b) Each individual performing moderate complexity testing must--
    (1) Follow the laboratory's procedures for specimen handling and 
processing, test analyses, reporting and maintaining records of patient 
test results;
    (2) Maintain records that demonstrate that proficiency testing 
samples are tested in the same manner as patient samples;
    (3) Adhere to the laboratory's quality control policies, document 
all quality control activities, instrument and procedural calibrations 
and maintenance performed;
    (4) Follow the laboratory's established corrective action policies 
and procedures whenever test systems are not within the laboratory's 
established acceptable levels of performance;
    (5) Be capable of identifying problems that may adversely affect 
test performance or reporting of test results and either must correct 
the problems or immediately notify the technical consultant, clinical 
consultant or director; and
    (6) Document all corrective actions taken when test systems deviate 
from the laboratory's established performance specifications.

             Laboratories Performing High Complexity Testing



Sec. 493.1441  Condition: Laboratories performing high complexity
testing; laboratory director.

    The laboratory must have a director who meets the qualification 
requirements of Sec. 493.1443 of this subpart and provides overall 
management and direction in accordance with Sec. 493.1445 of this 
subpart.



Sec. 493.1443  Standard; Laboratory director qualifications.

    The laboratory director must be qualified to manage and direct the 
laboratory personnel and performance of high complexity tests and must 
be eligible to be an operator of a laboratory within the requirements of 
subpart R.
    (a) The laboratory director must possess a current license as a 
laboratory

[[Page 724]]

director issued by the State in which the laboratory is located, if such 
licensing is required; and
    (b) The laboratory director must--
    (1)(i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in anatomic or clinical pathology, or both, by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology or possess qualifications that are equivalent to those 
required for such certification; or
    (2) Be a doctor of medicine, a doctor of osteopathy or doctor of 
podiatric medicine licensed to practice medicine, osteopathy or podiatry 
in the State in which the laboratory is located; and
    (i) Have at least one year of laboratory training during medical 
residency (for example, physicians certified either in hematology or 
hematology and medical oncology by the American Board of Internal 
Medicine); or
    (ii) Have at least 2 years of experience directing or supervising 
high complexity testing; or
    (3) Hold an earned doctoral degree in a chemical, physical, 
biological, or clinical laboratory science from an accredited 
institution and--
    (i) Be certified and continue to be certified by a board approved by 
HHS; or
    (ii) Before February 24, 2003, must have served or be serving as a 
director of a laboratory performing high complexity testing and must 
have at least--
    (A) Two years of laboratory training or experience, or both; and
    (B) Two years of laboratory experience directing or supervising high 
complexity testing.
    (4) Be serving as a laboratory director and must have previously 
qualified or could have qualified as a laboratory director under 
regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, 
on or before February 28, 1992; or
    (5) On or before February 28, 1992, be qualified under State law to 
direct a laboratory in the State in which the laboratory is located; or
    (6) For the subspecialty of oral pathology, be certified by the 
American Board of Oral Pathology, American Board of Pathology, the 
American Osteopathic Board of Pathology, or possess qualifications that 
are equivalent to those required for certification.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993; 59 
FR 62609, Dec. 6, 1994; 62 FR 25858, May 12, 1997; 63 FR 55034, Oct. 14, 
1998; 65 FR 82944, Dec. 29, 2000; 68 FR 3713, Jan. 24, 2003]



Sec. 493.1445  Standard; Laboratory director responsibilities.

    The laboratory director is responsible for the overall operation and 
administration of the laboratory, including the employment of personnel 
who are competent to perform test procedures, record and report test 
results promptly, accurately and proficiently, and for assuring 
compliance with the applicable regulations.
    (a) The laboratory director, if qualified, may perform the duties of 
the technical supervisor, clinical consultant, general supervisor, and 
testing personnel, or delegate these responsibilities to personnel 
meeting the qualifications under Sec. Sec. 493.1447, 493.1453, 
493.1459, and 493.1487, respectively.
    (b) If the laboratory director reapportions performance of his or 
her responsibilities, he or she remains responsible for ensuring that 
all duties are properly performed.
    (c) The laboratory director must be accessible to the laboratory to 
provide onsite, telephone or electronic consultation as needed.
    (d) Each individual may direct no more than five laboratories.
    (e) The laboratory director must--
    (1) Ensure that testing systems developed and used for each of the 
tests performed in the laboratory provide quality laboratory services 
for all aspects of test performance, which includes the preanalytic, 
analytic, and postanalytic phases of testing;
    (2) Ensure that the physical plant and environmental conditions of 
the laboratory are appropriate for the testing performed and provide a 
safe environment in which employees are protected from physical, 
chemical, and biological hazards;
    (3) Ensure that--
    (i) The test methodologies selected have the capability of providing 
the

[[Page 725]]

quality of results required for patient care;
    (ii) Verification procedures used are adequate to determine the 
accuracy, precision, and other pertinent performance characteristics of 
the method; and
    (iii) Laboratory personnel are performing the test methods as 
required for accurate and reliable results;
    (4) Ensure that the laboratory is enrolled in an HHS-approved 
proficiency testing program for the testing performed and that--
    (i) The proficiency testing samples are tested as required under 
subpart H of this part;
    (ii) The results are returned within the timeframes established by 
the proficiency testing program;
    (iii) All proficiency testing reports received are reviewed by the 
appropriate staff to evaluate the laboratory's performance and to 
identify any problems that require corrective action; and
    (iv) An approved corrective action plan is followed when any 
proficiency testing result is found to be unacceptable or 
unsatisfactory;
    (5) Ensure that the quality control and quality assessment programs 
are established and maintained to assure the quality of laboratory 
services provided and to identify failures in quality as they occur;
    (6) Ensure the establishment and maintenance of acceptable levels of 
analytical performance for each test system;
    (7) Ensure that all necessary remedial actions are taken and 
documented whenever significant deviations from the laboratory's 
established performance characteristics are identified, and that patient 
test results are reported only when the system is functioning properly;
    (8) Ensure that reports of test results include pertinent 
information required for interpretation;
    (9) Ensure that consultation is available to the laboratory's 
clients on matters relating to the quality of the test results reported 
and their interpretation concerning specific patient conditions;
    (10) Ensure that a general supervisor provides on-site supervision 
of high complexity test performance by testing personnel qualified under 
Sec. 493.1489(b)(4);
    (11) Employ a sufficient number of laboratory personnel with the 
appropriate education and either experience or training to provide 
appropriate consultation, properly supervise and accurately perform 
tests and report test results in accordance with the personnel 
responsibilities described in this subpart;
    (12) Ensure that prior to testing patients' specimens, all personnel 
have the appropriate education and experience, receive the appropriate 
training for the type and complexity of the services offered, and have 
demonstrated that they can perform all testing operations reliably to 
provide and report accurate results;
    (13) Ensure that policies and procedures are established for 
monitoring individuals who conduct preanalytical, analytical, and 
postanalytical phases of testing to assure that they are competent and 
maintain their competency to process specimens, perform test procedures 
and report test results promptly and proficiently, and whenever 
necessary, identify needs for remedial training or continuing education 
to improve skills;
    (14) Ensure that an approved procedure manual is available to all 
personnel responsible for any aspect of the testing process; and
    (15) Specify, in writing, the responsibilities and duties of each 
consultant and each supervisor, as well as each person engaged in the 
performance of the preanalytic, analytic, and postanalytic phases of 
testing, that identifies which examinations and procedures each 
individual is authorized to perform, whether supervision is required for 
specimen processing, test performance or result reporting and whether 
supervisory or director review is required prior to reporting patient 
test results.

[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3714, Jan. 24, 2003]



Sec. 493.1447  Condition: Laboratories performing high complexity 
testing; technical supervisor.

    The laboratory must have a technical supervisor who meets the 
qualification

[[Page 726]]

requirements of Sec. 493.1449 of this subpart and provides technical 
supervision in accordance with Sec. 493.1451 of this subpart.



Sec. 493.1449  Standard; Technical supervisor qualifications.

    The laboratory must employ one or more individuals who are qualified 
by education and either training or experience to provide technical 
supervision for each of the specialties and subspecialties of service in 
which the laboratory performs high complexity tests or procedures. The 
director of a laboratory performing high complexity testing may function 
as the technical supervisor provided he or she meets the qualifications 
specified in this section.
    (a) The technical supervisor must possess a current license issued 
by the State in which the laboratory is located, if such licensing is 
required; and
    (b) The laboratory may perform anatomic and clinical laboratory 
procedures and tests in all specialties and subspecialties of services 
except histocompatibility and clinical cytogenetics services provided 
the individual functioning as the technical supervisor--
    (1) Is a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (2) Is certified in both anatomic and clinical pathology by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology or Possesses qualifications that are equivalent to those 
required for such certification.
    (c) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the subspecialty of bacteriology, 
the individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least one year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of bacteriology; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of bacteriology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of bacteriology; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical, or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of bacteriology.
    (d) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the subspecialty of 
mycobacteriology, the individual functioning as the technical supervisor 
must--
    (1)(i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or

[[Page 727]]

the American Osteopathic Board of Pathology or possess qualifications 
that are equivalent to those required for such certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycobacteriology; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycobacteriology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycobacteriology; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycobacteriology.
    (e) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the subspecialty of mycology, the 
individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycology; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both in high complexity testing within the speciality of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycology; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of mycology.
    (f) If the requirements of paragraph (b) of this section are not met 
and the

[[Page 728]]

laboratory performs tests in the subspecialty of parasitology, the 
individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least one year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of parasitology;
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of parasitology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of parasitology; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of parasitology.
    (g) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the subspecialty of virology, the 
individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of virology; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of virology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing within the specialty of microbiology 
with a minimum of 6 months experience in high complexity testing within 
the subspecialty of virology; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in

[[Page 729]]

high complexity testing within the specialty of microbiology with a 
minimum of 6 months experience in high complexity testing within the 
subspecialty of virology.
    (h) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the specialty of diagnostic 
immunology, the individual functioning as the technical supervisor 
must--
    (1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing for the specialty of diagnostic 
immunology; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of diagnostic 
immunology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of diagnostic 
immunology; or
    (5) (i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of diagnostic 
immunology.
    (i) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the specialty of chemistry, the 
individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing for the specialty of chemistry; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of chemistry; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of chemistry; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of chemistry.
    (j) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the specialty of hematology, the 
individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and

[[Page 730]]

    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least one year of laboratory training or experience, or 
both, in high complexity testing for the specialty of hematology (for 
example, physicians certified either in hematology or hematology and 
medical oncology by the American Board of Internal Medicine); or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or clinical laboratory science from an accredited 
institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of hematology; or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of hematology; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of hematology.
    (k)(1) If the requirements of paragraph (b) of this section are not 
met and the laboratory performs tests in the subspecialty of cytology, 
the individual functioning as the technical supervisor must--
    (i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Meet one of the following requirements--
    (A) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (B) Be certified by the American Society of Cytology to practice 
cytopathology or possess qualifications that are equivalent to those 
required for such certification;
    (2) An individual qualified under Sec. 493.1449(b) or paragraph 
(k)(1) of this section may delegate some of the cytology technical 
supervisor responsibilities to an individual who is in the final year of 
full-time training leading to certification specified in paragraphs (b) 
or (k)(1)(ii)(A) of this section provided the technical supervisor 
qualified under Sec. 493.1449(b) or paragraph (k)(1) of this section 
remains ultimately responsible for ensuring that all of the 
responsibilities of the cytology technical supervisor are met.
    (l) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the subspecialty of histopathology, 
the individual functioning as the technical supervisor must--
    (1) Meet one of the following requirements:
    (i) (A) Be a doctor of medicine or a doctor of osteopathy licensed 
to practice medicine or osteopathy in the State in which the laboratory 
is located; and
    (B) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification;
    (ii) An individual qualified under Sec. 493.1449(b) or paragraph 
(l)(1) of this section may delegate to an individual who is a resident 
in a training program leading to certification specified in paragraph 
(b) or (l)(1)(i)(B) of this section, the responsibility for examination 
and interpretation of histopathology specimens.
    (2) For tests in dermatopathology, meet one of the following 
requirements:
    (i) (A) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located and--
    (B) Meet one of the following requirements:

[[Page 731]]

    (1) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2) Be certified in dermatopathology by the American Board of 
Dermatology and the American Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (3) Be certified in dermatology by the American Board of Dermatology 
or possess qualifications that are equivalent to those required for such 
certification; or
    (ii) An individual qualified under Sec. 493.1449(b) or paragraph 
(l)(2)(i) of this section may delegate to an individual who is a 
resident in a training program leading to certification specified in 
paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for 
examination and interpretation of dermatopathology specimens.
    (3) For tests in ophthalmic pathology, meet one of the following 
requirements:
    (i)(A) Be a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located and--
    (B) Must meet one of the following requirements:
    (1) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2) Be certified by the American Board of Ophthalmology or possess 
qualifications that are equivalent to those required for such 
certitication and have successfully completed at least 1 year of formal 
post-residency fellowship training in ophthalmic pathology; or
    (ii) An individual qualified under Sec. 493.1449(b) or paragraph 
(1)(3)(i) of this section may delegate to an individual who is a 
resident in a training program leading to certification specified in 
paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for 
examination and interpretation of ophthalmic specimens; or
    (m) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the subspecialty of oral pathology, 
the individual functioning as the technical supervisor must meet one of 
the following requirements:
    (1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located and--
    (ii) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2) Be certified in oral pathology by the American Board of Oral 
Pathology or possess qualifications for such certification; or
    (3) An individual qualified under Sec. 493.1449(b) or paragraph (m) 
(1) or (2) of this section may delegate to an individual who is a 
resident in a training program leading to certification specified in 
paragraphs (b) or (m) (1) or (2) of this section, the responsibility for 
examination and interpretation of oral pathology specimens.
    (n) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the specialty of radiobioassay, the 
individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing for the specialty of radiobioassay; or
    (3)(i) Have an earned doctoral degree in a chemical, physical, 
biological or

[[Page 732]]

clinical laboratory science from an accredited institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the specialty of radiobioassay; 
or
    (4)(i) Have earned a master's degree in a chemical, physical, 
biological or clinical laboratory science or medical technology from an 
accredited institution; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of radiobioassay; or
    (5)(i) Have earned a bachelor's degree in a chemical, physical or 
biological science or medical technology from an accredited institution; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing for the specialty of radiobioassay.
    (o) If the laboratory performs tests in the specialty of 
histocompatibility, the individual functioning as the technical 
supervisor must either--
    (1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have training or experience that meets one of the following 
requirements:
    (A) Have 4 years of laboratory training or experience, or both, 
within the specialty of histocompatibility; or
    (B)(1) Have 2 years of laboratory training or experience, or both, 
in the specialty of general immunology; and
    (2) Have 2 years of laboratory training or experience, or both, in 
the specialty of histocompatibility; or
    (2)(i) Have an earned doctoral degree in a biological or clinical 
laboratory science from an accredited institution; and
    (ii) Have training or experience that meets one of the following 
requirements:
    (A) Have 4 years of laboratory training or experience, or both, 
within the specialty of histocompatibility; or
    (B)(1) Have 2 years of laboratory training or experience, or both, 
in the specialty of general immunology; and
    (2) Have 2 years of laboratory training or experience, or both, in 
the specialty of histocompatibility.
    (p) If the laboratory performs tests in the specialty of clinical 
cytogenetics, the individual functioning as the technical supervisor 
must--
    (1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have 4 years of training or experience, or both, in genetics, 2 
of which have been in clinical cytogenetics; or
    (2)(i) Hold an earned doctoral degree in a biological science, 
including biochemistry, or clinical laboratory science from an 
accredited institution; and
    (ii) Have 4 years of training or experience, or both, in genetics, 2 
of which have been in clinical cytogenetics.
    (q) If the requirements of paragraph (b) of this section are not met 
and the laboratory performs tests in the specialty of immunohematology, 
the individual functioning as the technical supervisor must--
    (1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located; and
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology or possess 
qualifications that are equivalent to those required for such 
certification; or
    (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located; and
    (ii) Have at least one year of laboratory training or experience, or 
both, in high complexity testing for the specialty of immunohematology.

    Note: The technical supervisor requirements for ``laboratory 
training or experience, or both'' in each specialty or subspecialty may 
be acquired concurrently in more than one of the specialties or 
subspecialties of service. For example, an individual, who has a 
doctoral degree in chemistry and additionally has documentation of 1 
year of laboratory experience working concurrently in high complexity 
testing in the specialties of microbiology and chemistry

[[Page 733]]

and 6 months of that work experience included high complexity testing in 
bacteriology, mycology, and mycobacteriology, would qualify as the 
technical supervisor for the specialty of chemistry and the 
subspecialties of bacteriology, mycology, and mycobacteriology.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]



Sec. 493.1451  Standard: Technical supervisor responsibilities.

    The technical supervisor is responsible for the technical and 
scientific oversight of the laboratory. The technical supervisor is not 
required to be on site at all times testing is performed; however, he or 
she must be available to the laboratory on an as needed basis to provide 
supervision as specified in (a) of this section.
    (a) The technical supervisor must be accessible to the laboratory to 
provide on-site, telephone, or electronic consultation; and
    (b) The technical supervisor is responsible for--
    (1) Selection of the test methodology that is appropriate for the 
clinical use of the test results;
    (2) Verification of the test procedures performed and establishment 
of the laboratory's test performance characteristics, including the 
precision and accuracy of each test and test system;
    (3) Enrollment and participation in an HHS approved proficiency 
testing program commensurate with the services offered;
    (4) Establishing a quality control program appropriate for the 
testing performed and establishing the parameters for acceptable levels 
of analytic performance and ensuring that these levels are maintained 
throughout the entire testing process from the initial receipt of the 
specimen, through sample analysis and reporting of test results;
    (5) Resolving technical problems and ensuring that remedial actions 
are taken whenever test systems deviate from the laboratory's 
established performance specifications;
    (6) Ensuring that patient test results are not reported until all 
corrective actions have been taken and the test system is functioning 
properly;
    (7) Identifying training needs and assuring that each individual 
performing tests receives regular in-service training and education 
appropriate for the type and complexity of the laboratory services 
performed;
    (8) Evaluating the competency of all testing personnel and assuring 
that the staff maintain their competency to perform test procedures and 
report test results promptly, accurately and proficiently. The 
procedures for evaluation of the competency of the staff must include, 
but are not limited to--
    (i) Direct observations of routine patient test performance, 
including patient preparation, if applicable, specimen handling, 
processing and testing;
    (ii) Monitoring the recording and reporting of test results;
    (iii) Review of intermediate test results or worksheets, quality 
control records, proficiency testing results, and preventive maintenance 
records;
    (iv) Direct observation of performance of instrument maintenance and 
function checks;
    (v) Assessment of test performance through testing previously 
analyzed specimens, internal blind testing samples or external 
proficiency testing samples; and
    (vi) Assessment of problem solving skills; and
    (9) Evaluating and documenting the performance of individuals 
responsible for high complexity testing at least semiannually during the 
first year the individual tests patient specimens. Thereafter, 
evaluations must be performed at least annually unless test methodology 
or instrumentation changes, in which case, prior to reporting patient 
test results, the individual's performance must be reevaluated to 
include the use of the new test methodology or instrumentation.
    (c) In cytology, the technical supervisor or the individual 
qualified under Sec. 493.1449(k)(2)--
    (1) May perform the duties of the cytology general supervisor and 
the cytotechnologist, as specified in Sec. Sec. 493.1471 and 493.1485, 
respectively;
    (2) Must establish the workload limit for each individual examining 
slides;
    (3) Must reassess the workload limit for each individual examining 
slides at least every 6 months and adjust as necessary;

[[Page 734]]

    (4) Must perform the functions specified in Sec. 493.1274(d) and 
(e);
    (5) Must ensure that each individual examining gynecologic 
preparations participates in an HHS approved cytology proficiency 
testing program, as specified in Sec. 493.945 and achieves a passing 
score, as specified in Sec. 493.855; and
    (6) If responsible for screening cytology slide preparations, must 
document the number of cytology slides screened in 24 hours and the 
number of hours devoted during each 24-hour period to screening cytology 
slides.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 68 
FR 3714, Jan. 24, 2003]



Sec. 493.1453  Condition: Laboratories performing high complexity 
testing; clinical consultant.

    The laboratory must have a clinical consultant who meets the 
requirements of Sec. 493.1455 of this subpart and provides clinical 
consultation in accordance with Sec. 493.1457 of this subpart.



Sec. 493.1455  Standard; Clinical consultant qualifications.

    The clinical consultant must be qualified to consult with and render 
opinions to the laboratory's clients concerning the diagnosis, treatment 
and management of patient care. The clinical consultant must--
    (a) Be qualified as a laboratory director under Sec. 
493.1443(b)(1), (2), or (3)(i) or, for the subspecialty of oral 
pathology, Sec. 493.1443(b)(6); or
    (b) Be a doctor of medicine, doctor of osteopathy, doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993]



Sec. 493.1457  Standard; Clinical consultant responsibilities.

    The clinical consultant provides consultation regarding the 
appropriateness of the testing ordered and interpretation of test 
results. The clinical consultant must--
    (a) Be available to provide consultation to the laboratory's 
clients;
    (b) Be available to assist the laboratory's clients in ensuring that 
appropriate tests are ordered to meet the clinical expectations;
    (c) Ensure that reports of test results include pertinent 
information required for specific patient interpretation; and
    (d) Ensure that consultation is available and communicated to the 
laboratory's clients on matters related to the quality of the test 
results reported and their interpretation concerning specific patient 
conditions.



Sec. 493.1459  Condition: Laboratories performing high complexity 
testing; general supervisor.

    The laboratory must have one or more general supervisors who are 
qualified under Sec. 493.1461 of this subpart to provide general 
supervision in accordance with Sec. 493.1463 of this subpart.



Sec. 493.1461  Standard: General supervisor qualifications.

    The laboratory must have one or more general supervisors who, under 
the direction of the laboratory director and supervision of the 
technical supervisor, provides day-to-day supervision of testing 
personnel and reporting of test results. In the absence of the director 
and technical supervisor, the general supervisor must be responsible for 
the proper performance of all laboratory procedures and reporting of 
test results.
    (a) The general supervisor must possess a current license issued by 
the State in which the laboratory is located, if such licensing is 
required; and
    (b) The general supervisor must be qualified as a--
    (1) Laboratory director under Sec. 493.1443; or
    (2) Technical supervisor under Sec. 493.1449.
    (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of 
this section are not met, the individual functioning as the general 
supervisor must--
    (1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located or have earned 
a doctoral, master's, or bachelor's degree in a chemical, physical, 
biological or clinical laboratory science, or medical technology from an 
accredited institution; and

[[Page 735]]

    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing; or
    (2)(i) Qualify as testing personnel under Sec. 493.1489(b)(2); and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing; or
    (3)(i) Except as specified in paragraph (3)(ii) of this section, 
have previously qualified as a general supervisor under Sec. 493.1462 
on or before February 28, 1992.
    (ii) Exception. An individual who achieved a satisfactory grade in a 
proficiency examination for technologist given by HHS between March 1, 
1986 and December 31, 1987, qualifies as a general supervisor if he or 
she meets the requirements of Sec. 493.1462 on or before January 1, 
1994.''
    (4) On or before September 1, 1992, have served as a general 
supervisor of high complexity testing and as of April 24, 1995--
    (i) Meet one of the following requirements:
    (A) Have graduated from a medical laboratory or clinical laboratory 
training program approved or accredited by the Accrediting Bureau of 
Health Education Schools (ABHES), the Commission on Allied Health 
Education Accreditation (CAHEA), or other organization approved by HHS.
    (B) Be a high school graduate or equivalent and have successfully 
completed an official U.S. military medical laboratory procedures course 
of at least 50 weeks duration and have held the military enlisted 
occupational specialty of Medical Laboratory Specialist (Laboratory 
Technician).
    (ii) Have at least 2 years of clinical laboratory training, or 
experience, or both, in high complexity testing; or
    (5) On or before September 1, 1992, have served as a general 
supervisor of high complexity testing and--
    (i) Be a high school graduate or equivalent; and
    (ii) Have had at least 10 years of laboratory training or 
experience, or both, in high complexity testing, including at least 6 
years of supervisory experience between September 1, 1982 and September 
1, 1992.
    (d) For blood gas analysis, the individual providing general 
supervision must--
    (1) Be qualified under Sec. 493.1461(b) (1) or (2), or Sec. 
493.1461(c); or
    (2)(i) Have earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution; and
    (ii) Have at least one year of laboratory training or experience, or 
both, in blood gas analysis; or
    (3)(i) Have earned an associate degree related to pulmonary function 
from an accredited institution; and
    (ii) Have at least two years of training or experience, or both in 
blood gas analysis.
    (e) The general supervisor requirement is met in histopathology, 
oral pathology, dermatopathology, and ophthalmic pathology because all 
tests and examinations, must be performed:
    (1) In histopathology, by an individual who is qualified as a 
technical supervisor under Sec. 493.1449(b) or Sec. 493.1449(l)(1);
    (2) In dermatopathology, by an individual who is qualified as a 
technical supervisor under Sec. 493.1449(b) or Sec. 493.1449(l) or 
(2);
    (3) In ophthalmic pathology, by an individual who is qualified as a 
technical supervisor under Sec. 493.1449(b) or Sec. 493.1449(1)(3); 
and
    (4) In oral pathology, by an individual who is qualified as a 
technical supervisor under Sec. 493.1449(b) or Sec. 493.1449(m).

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 58 
FR 39155, July 22, 1993; 60 FR 20049, Apr. 24, 1995]



Sec. 493.1462  General supervisor qualifications on or before February
28, 1992.

    To qualify as a general supervisor under Sec. 493.1461(c)(3), an 
individual must have met or could have met the following qualifications 
as they were in effect on or before February 28, 1992.
    (a) Each supervisor possesses a current license as a laboratory 
supervisor issued by the State, if such licensing exists; and
    (b) The laboratory supervisor--
    (1) Who qualifies as a laboratory director under Sec. 
493.1406(b)(1), (2), (4), or (5) is also qualified as a general 
supervisor; therefore, depending upon the size and functions of the 
laboratory,

[[Page 736]]

the laboratory director may also serve as the laboratory supervisor; or
    (2)(i) Is a physician or has earned a doctoral degree from an 
accredited institution with a major in one of the chemical, physical, or 
biological sciences; and
    (ii) Subsequent to graduation, has had at least 2 years of 
experience in one of the laboratory specialties in a laboratory; or
    (3)(i) Holds a master's degree from an accredited institution with a 
major in one of the chemical, physical, or biological sciences; and
    (ii) Subsequent to graduation has had at least 4 years of pertinent 
full-time laboratory experience of which not less than 2 years have been 
spent working in the designated specialty in a laboratory; or
    (4)(i) Is qualified as a laboratory technologist under Sec. 
493.1491; and
    (ii) After qualifying as a laboratory technologist, has had at least 
6 years of pertinent full-time laboratory experience of which not less 
than 2 years have been spent working in the designated laboratory 
specialty in a laboratory; or
    (5) With respect to individuals first qualifying before July 1, 
1971, has had at least 15 years of pertinent full-time laboratory 
experience before January 1, 1968; this required experience may be met 
by the substitution of education for experience.

[58 FR 39155, July 22, 1993]



Sec. 493.1463  Standard: General supervisor responsibilities.

    The general supervisor is responsible for day-to-day supervision or 
oversight of the laboratory operation and personnel performing testing 
and reporting test results.
    (a) The general supervisor--(1) Must be accessible to testing 
personnel at all times testing is performed to provide on-site, 
telephone or electronic consultation to resolve technical problems in 
accordance with policies and procedures established either by the 
laboratory director or technical supervisor;
    (2) Is responsible for providing day-to-day supervision of high 
complexity test performance by a testing personnel qualified under Sec. 
493.1489;
    (3) Except as specified in paragraph (c) of this section, must be 
onsite to provide direct supervision when high complexity testing is 
performed by any individuals qualified under Sec. 493.1489(b)(5); and
    (4) Is responsible for monitoring test analyses and specimen 
examinations to ensure that acceptable levels of analytic performance 
are maintained.
    (b) The director or technical supervisor may delegate to the general 
supervisor the responsibility for--
    (1) Assuring that all remedial actions are taken whenever test 
systems deviate from the laboratory's established performance 
specifications;
    (2) Ensuring that patient test results are not reported until all 
corrective actions have been taken and the test system is properly 
functioning;
    (3) Providing orientation to all testing personnel; and
    (4) Annually evaluating and documenting the performance of all 
testing personnel.
    (c) Exception. For individuals qualified under Sec. 493.1489(b)(5), 
who were performing high complexity testing on or before January 19, 
1993, the requirements of paragraph (a)(3) of this section are not 
effective, provided that all high complexity testing performed by the 
individual in the absence of a general supervisor is reviewed within 24 
hours by a general supervisor qualified under Sec. 493.1461.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 60 
FR 20050, Apr. 24, 1995]



Sec. 493.1467  Condition: Laboratories performing high complexity 
testing; cytology general supervisor.

    For the subspecialty of cytology, the laboratory must have a general 
supervisor who meets the qualification requirements of Sec. 493.1469 of 
this subpart, and provides supervision in accordance with Sec. 493.1471 
of this subpart.



Sec. 493.1469  Standard: Cytology general supervisor qualifications.

    The cytology general supervisor must be qualified to supervise 
cytology services. The general supervisor in cytology must possess a 
current license

[[Page 737]]

issued by the State in which the laboratory is located, if such 
licensing is required, and must--
    (a) Be qualified as a technical supervisor under Sec. 493.1449 (b) 
or (k); or
    (b)(1) Be qualified as a cytotechnologist under Sec. 493.1483; and
    (2) Have at least 3 years of full-time (2,080 hours per year) 
experience as a cytotechnologist within the preceding 10 years.



Sec. 493.1471  Standard: Cytology general supervisor responsibilities.

    The technical supervisor of cytology may perform the duties of the 
cytology general supervisor or delegate the responsibilities to an 
individual qualified under Sec. 493.1469.
    (a) The cytology general supervisor is responsible for the day-to-
day supervision or oversight of the laboratory operation and personnel 
performing testing and reporting test results.
    (b) The cytology general supervisor must--
    (1) Be accessible to provide on-site, telephone, or electronic 
consultation to resolve technical problems in accordance with policies 
and procedures established by the technical supervisor of cytology;
    (2) Document the slide interpretation results of each gynecologic 
and nongynecologic cytology case he or she examined or reviewed (as 
specified under Sec. 493.1274(c));
    (3) For each 24-hour period, document the total number of slides he 
or she examined or reviewed in the laboratory as well as the total 
number of slides examined or reviewed in any other laboratory or for any 
other employer; and
    (4) Document the number of hours spent examining slides in each 24-
hour period.

[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3714, Jan. 24, 2003]



Sec. 493.1481  Condition: Laboratories performing high complexity
testing; cytotechnologist.

    For the subspecialty of cytology, the laboratory must have a 
sufficient number of cytotechnologists who meet the qualifications 
specified in Sec. 493.1483 to perform the functions specified in Sec. 
493.1485.



Sec. 493.1483  Standard: Cytotechnologist qualifications.

    Each person examining cytology slide preparations must meet the 
qualifications of Sec. 493.1449 (b) or (k), or--
    (a) Possess a current license as a cytotechnologist issued by the 
State in which the laboratory is located, if such licensing is required; 
and
    (b) Meet one of the following requirements:
    (1) Have graduated from a school of cytotechnology accredited by the 
Committee on Allied Health Education and Accreditation or other 
organization approved by HHS; or
    (2) Be certified in cytotechnology by a certifying agency approved 
by HHS; or
    (3) Before September 1, 1992--
    (i) Have successfully completed 2 years in an accredited institution 
with at least 12 semester hours in science, 8 hours of which are in 
biology; and
    (A) Have had 12 months of training in a school of cytotechnology 
accredited by an accrediting agency approved by HHS; or
    (B) Have received 6 months of formal training in a school of 
cytotechnology accredited by an accrediting agency approved by HHS and 6 
months of full-time experience in cytotechnology in a laboratory 
acceptable to the pathologist who directed the formal 6 months of 
training; or
    (ii) Have achieved a satisfactory grade to qualify as a 
cytotechnologist in a proficiency examination approved by HHS and 
designed to qualify persons as cytotechnologists; or
    (4) Before September 1, 1994, have full-time experience of at least 
2 years or equivalent within the preceding 5 years examining slide 
preparations under the supervision of a physician qualified under Sec. 
493.1449(b) or (k)(1), and before January 1, 1969, must have--
    (i) Graduated from high school;
    (ii) Completed 6 months of training in cytotechnology in a 
laboratory directed by a pathologist or other physician providing 
cytology services; and
    (iii) Completed 2 years of full-time supervised experience in 
cytotechnology; or
    (5)(i) On or before September 1, 1994, have full-time experience of 
at least 2

[[Page 738]]

years or equivalent examining cytology slide preparations within the 
preceding 5 years in the United States under the supervision of a 
physician qualified under Sec. 493.1449(b) or (k)(1); and
    (ii) On or before September 1, 1995, have met the requirements in 
either paragraph (b)(1) or (2) of this section.

[57 FR 7172, Feb. 28, 1992, as amended at 59 FR 685, Jan. 6, 1994]



Sec. 493.1485  Standard; Cytotechnologist responsibilities.

    The cytotechnologist is responsible for documenting--
    (a) The slide interpretation results of each gynecologic and 
nongynecologic cytology case he or she examined or reviewed (as 
specified in Sec. 493.1274(c));
    (b) For each 24-hour period, the total number of slides examined or 
reviewed in the laboratory as well as the total number of slides 
examined or reviewed in any other laboratory or for any other employer; 
and
    (c) The number of hours spent examining slides in each 24-hour 
period.

[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3714, Jan. 24, 2003]



Sec. 493.1487  Condition: Laboratories performing high complexity
testing; testing personnel.

    The laboratory has a sufficient number of individuals who meet the 
qualification requirements of Sec. 493.1489 of this subpart to perform 
the functions specified in Sec. 493.1495 of this subpart for the volume 
and complexity of testing performed.



Sec. 493.1489  Standard; Testing personnel qualifications.

    Each individual performing high complexity testing must--
    (a) Possess a current license issued by the State in which the 
laboratory is located, if such licensing is required; and
    (b) Meet one of the following requirements:
    (1) Be a doctor of medicine, doctor of osteopathy, or doctor of 
podiatric medicine licensed to practice medicine, osteopathy, or 
podiatry in the State in which the laboratory is located or have earned 
a doctoral, master's or bachelor's degree in a chemical, physical, 
biological or clinical laboratory science, or medical technology from an 
accredited institution;
    (2)(i) Have earned an associate degree in a laboratory science, or 
medical laboratory technology from an accredited institution or--
    (ii) Have education and training equivalent to that specified in 
paragraph (b)(2)(i) of this section that includes--
    (A) At least 60 semester hours, or equivalent, from an accredited 
institution that, at a minimum, include either--
    (1) 24 semester hours of medical laboratory technology courses; or
    (2) 24 semester hours of science courses that include--
    (i) Six semester hours of chemistry;
    (ii) Six semester hours of biology; and
    (iii) Twelve semester hours of chemistry, biology, or medical 
laboratory technology in any combination; and
    (B) Have laboratory training that includes either of the following:
    (1) Completion of a clinical laboratory training program approved or 
accredited by the ABHES, the CAHEA, or other organization approved by 
HHS. (This training may be included in the 60 semester hours listed in 
paragraph (b)(2)(ii)(A) of this section.)
    (2) At least 3 months documented laboratory training in each 
specialty in which the individual performs high complexity testing.
    (3) Have previously qualified or could have qualified as a 
technologist under Sec. 493.1491 on or before February 28, 1992;
    (4) On or before April 24, 1995 be a high school graduate or 
equivalent and have either--
    (i) Graduated from a medical laboratory or clinical laboratory 
training program approved or accredited by ABHES, CAHEA, or other 
organization approved by HHS; or
    (ii) Successfully completed an official U.S. military medical 
laboratory procedures training course of at least 50 weeks duration and 
have held the military enlisted occupational specialty of Medical 
Laboratory Specialist (Laboratory Technician);
    (5)(i) Until September 1, 1997--
    (A) Have earned a high school diploma or equivalent; and

[[Page 739]]

    (B) Have documentation of training appropriate for the testing 
performed before analyzing patient specimens. Such training must ensure 
that the individual has--
    (1) The skills required for proper specimen collection, including 
patient preparation, if applicable, labeling, handling, preservation or 
fixation, processing or preparation, transportation and storage of 
specimens;
    (2) The skills required for implementing all standard laboratory 
procedures;
    (3) The skills required for performing each test method and for 
proper instrument use;
    (4) The skills required for performing preventive maintenance, 
troubleshooting, and calibration procedures related to each test 
performed;
    (5) A working knowledge of reagent stability and storage;
    (6) The skills required to implement the quality control policies 
and procedures of the laboratory;
    (7) An awareness of the factors that influence test results; and
    (8) The skills required to assess and verify the validity of patient 
test results through the evaluation of quality control values before 
reporting patient test results; and
    (ii) As of September 1, 1997, be qualified under Sec. 
493.1489(b)(1), (b)(2), or (b)(4), except for those individuals 
qualified under paragraph (b)(5)(i) of this section who were performing 
high complexity testing on or before April 24, 1995;
    (6) For blood gas analysis--
    (i) Be qualified under Sec. 493.1489(b)(1), (b)(2), (b)(3), (b)(4), 
or (b)(5);
    (ii) Have earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution; or
    (iii) Have earned an associate degree related to pulmonary function 
from an accredited institution; or
    (7) For histopathology, meet the qualifications of Sec. 493.1449 
(b) or (l) to perform tissue examinations.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 58 
FR 39155, July 22, 1993; 60 FR 20050, Apr. 24, 1995]



Sec. 493.1491  Technologist qualifications on or before 
February 28, 1992.

    In order to qualify as high complexity testing personnel under Sec. 
493.1489(b)(3), the individual must have met or could have met the 
following qualifications for technologist as they were in effect on or 
before February 28, 1992. Each technologist must--
    (a) Possess a current license as a laboratory technologist issued by 
the State, if such licensing exists; and
    (b)(1) Have earned a bachelor's degree in medical technology from an 
accredited university; or
    (2) Have successfully completed 3 years of academic study (a minimum 
of 90 semester hours or equivalent) in an accredited college or 
university, which met the specific requirements for entrance into a 
school of medical technology accredited by an accrediting agency 
approved by the Secretary, and has successfully completed a course of 
training of at least 12 months in such a school; or
    (3) Have earned a bachelor's degree in one of the chemical, 
physical, or biological sciences and, in addition, has at least 1 year 
of pertinent full-time laboratory experience or training, or both, in 
the specialty or subspecialty in which the individual performs tests; or
    (4)(i) Have successfully completed 3 years (90 semester hours or 
equivalent) in an accredited college or university with the following 
distribution of courses--
    (A) For those whose training was completed before September 15, 
1963. At least 24 semester hours in chemistry and biology courses of 
which--
    (1) At least 6 semester hours were in inorganic chemistry and at 
least 3 semester hours were in other chemistry courses; and
    (2) At least 12 semester hours in biology courses pertinent to the 
medical sciences; or
    (B) For those whose training was completed after September 14, 1963. 
(1) 16 semester hours in chemistry courses that included at least 6 
semester hours in inorganic chemistry and that are acceptable toward a 
major in chemistry;

[[Page 740]]

    (2) 16 semester hours in biology courses that are pertinent to the 
medical sciences and are acceptable toward a major in the biological 
sciences; and
    (3) 3 semester hours of mathematics; and
    (ii) Has experience, training, or both, covering several fields of 
medical laboratory work of at least 1 year and of such quality as to 
provide him or her with education and training in medical technology 
equivalent to that described in paragraphs (b)(1) and (2) of this 
section; or
    (5) With respect to individuals first qualifying before July 1, 
1971, the technologist--
    (i) Was performing the duties of a laboratory technologist at any 
time between July 1, 1961, and January 1, 1968, and
    (ii) Has had at least 10 years of pertinent laboratory experience 
prior to January 1, 1968. (This required experience may be met by the 
substitution of education for experience); or
    (6) Achieves a satisfactory grade in a proficiency examination 
approved by HHS.

[58 FR 39155, July 22, 1993]



Sec. 493.1495  Standard; Testing personnel responsibilities.

    The testing personnel are responsible for specimen processing, test 
performance and for reporting test results.
    (a) Each individual performs only those high complexity tests that 
are authorized by the laboratory director and require a degree of skill 
commensurate with the individual's education, training or experience, 
and technical abilities.
    (b) Each individual performing high complexity testing must--
    (1) Follow the laboratory's procedures for specimen handling and 
processing, test analyses, reporting and maintaining records of patient 
test results;
    (2) Maintain records that demonstrate that proficiency testing 
samples are tested in the same manner as patient specimens;
    (3) Adhere to the laboratory's quality control policies, document 
all quality control activities, instrument and procedural calibrations 
and maintenance performed;
    (4) Follow the laboratory's established policies and procedures 
whenever test systems are not within the laboratory's established 
acceptable levels of performance;
    (5) Be capable of identifying problems that may adversely affect 
test performance or reporting of test results and either must correct 
the problems or immediately notify the general supervisor, technical 
supervisor, clinical consultant, or director;
    (6) Document all corrective actions taken when test systems deviate 
from the laboratory's established performance specifications; and
    (7) Except as specified in paragraph (c) of this section, if 
qualified under Sec. 493.1489(b)(5), perform high complexity testing 
only under the onsite, direct supervision of a general supervisor 
qualified under Sec. 493.1461.
    (c) Exception. For individuals qualified under Sec. 493.1489(b)(5), 
who were performing high complexity testing on or before January 19, 
1993, the requirements of paragraph (b)(7) of this section are not 
effective, provided that all high complexity testing performed by the 
individual in the absence of a general supervisor is reviewed within 24 
hours by a general supervisor qualified under Sec. 493.1461.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 60 
FR 20050, Apr. 24, 1995]

Subparts N-P [Reserved]



                          Subpart Q_Inspection

    Source: 57 FR 7184, Feb. 28, 1992, unless otherwise noted.



Sec. 493.1771  Condition: Inspection requirements applicable to
all CLIA-certified and CLIA-exempt laboratories.

    (a) Each laboratory issued a CLIA certificate must meet the 
requirements in Sec. 493.1773 and the specific requirements for its 
certificate type, as specified in Sec. Sec. 493.1775 through 493.1780.
    (b) All CLIA-exempt laboratories must comply with the inspection 
requirements in Sec. Sec. 493.1773 and 493.1780, when applicable.

[63 FR 26737, May 14, 1998]

[[Page 741]]



Sec. 493.1773  Standard: Basic inspection requirements for all 
laboratories issued a CLIA certificate and CLIA-exempt laboratories.

    (a) A laboratory issued a certificate must permit CMS or a CMS agent 
to conduct an inspection to assess the laboratory's compliance with the 
requirements of this part. A CLIA-exempt laboratory and a laboratory 
that requests, or is issued a certificate of accreditation, must permit 
CMS or a CMS agent to conduct validation and complaint inspections.
    (b) General requirements. As part of the inspection process, CMS or 
a CMS agent may require the laboratory to do the following:
    (1) Test samples, including proficiency testing samples, or perform 
procedures.
    (2) Permit interviews of all personnel concerning the laboratory's 
compliance with the applicable requirements of this part.
    (3) Permit laboratory personnel to be observed performing all phases 
of the total testing process (preanalytic, analytic, and postanalytic).
    (4) Permit CMS or a CMS agent access to all areas encompassed under 
the certificate including, but not limited to, the following:
    (i) Specimen procurement and processing areas.
    (ii) Storage facilities for specimens, reagents, supplies, records, 
and reports.
    (iii) Testing and reporting areas.
    (5) Provide CMS or a CMS agent with copies or exact duplicates of 
all records and data it requires.
    (c) Accessible records and data. A laboratory must have all records 
and data accessible and retrievable within a reasonable time frame 
during the course of the inspection.
    (d) Requirement to provide information and data. A laboratory must 
provide, upon request, all information and data needed by CMS or a CMS 
agent to make a determination of the laboratory's compliance with the 
applicable requirements of this part.
    (e) Reinspection. CMS or a CMS agent may reinspect a laboratory at 
any time to evaluate the ability of the laboratory to provide accurate 
and reliable test results.
    (f) Complaint inspection. CMS or a CMS agent may conduct an 
inspection when there are complaints alleging noncompliance with any of 
the requirements of this part.
    (g) Failure to permit an inspection or reinspection. Failure to 
permit CMS or a CMS agent to conduct an inspection or reinspection 
results in the suspension or cancellation of the laboratory's 
participation in Medicare and Medicaid for payment, and suspension or 
limitation of, or action to revoke the laboratory's CLIA certificate, in 
accordance with subpart R of this part.

[63 FR 26737, May 14, 1998; 63 FR 32699, June 15, 1998]



Sec. 493.1775  Standard: Inspection of laboratories issued 
a certificate of waiver or a certificate for provider-performed
microscopy procedures.

    (a) A laboratory that has been issued a certificate of waiver or a 
certificate for provider-performed microscopy procedures is not subject 
to biennial inspections.
    (b) If necessary, CMS or a CMS agent may conduct an inspection of a 
laboratory issued a certificate of waiver or a certificate for provider-
performed microscopy procedures at any time during the laboratory's 
hours of operation to do the following:
    (1) Determine if the laboratory is operated and testing is performed 
in a manner that does not constitute an imminent and serious risk to 
public health.
    (2) Evaluate a complaint from the public.
    (3) Determine whether the laboratory is performing tests beyond the 
scope of the certificate held by the laboratory.
    (4) Collect information regarding the appropriateness of tests 
specified as waived tests or provider-performed microscopy procedures.
    (c) The laboratory must comply with the basic inspection 
requirements of Sec. 493.1773.

[63 FR 26737, May 14, 1998]



Sec. 493.1777  Standard: Inspection of laboratories that have
requested or have been issued a certificate of compliance.

    (a) Initial inspection. (1) A laboratory issued a registration 
certificate must

[[Page 742]]

permit an initial inspection to assess the laboratory's compliance with 
the requirements of this part before CMS issues a certificate of 
compliance.
    (2) The inspection may occur at any time during the laboratory's 
hours of operation.
    (b) Subsequent inspections. (1) CMS or a CMS agent may conduct 
subsequent inspections on a biennial basis or with such other frequency 
as CMS determines to be necessary to ensure compliance with the 
requirements of this part.
    (2) CMS bases the nature of subsequent inspections on the 
laboratory's compliance history.
    (c) Provider-performed microscopy procedures. The inspection sample 
for review may include testing in the subcategory of provider-performed 
microscopy procedures.
    (d) Compliance with basic inspection requirements. The laboratory 
must comply with the basic inspection requirements of Sec. 493.1773.

[63 FR 26738, May 14, 1998]



Sec. 493.1780  Standard: Inspection of CLIA-exempt laboratories 
or laboratories requesting or issued a certificate of accreditation.

    (a) Validation inspection. CMS or a CMS agent may conduct a 
validation inspection of any accredited or CLIA-exempt laboratory at any 
time during its hours of operation.
    (b) Complaint inspection. CMS or a CMS agent may conduct a complaint 
inspection of a CLIA-exempt laboratory or a laboratory requesting or 
issued a certificate of accreditation at any time during its hours of 
operation upon receiving a complaint applicable to the requirements of 
this part.
    (c) Noncompliance determination. If a validation or complaint 
inspection results in a finding that the laboratory is not in compliance 
with one or more condition-level requirements, the following actions 
occur:
    (1) A laboratory issued a certificate of accreditation is subject to 
a full review by CMS, in accordance with subpart E of this part and 
Sec. 488.11 of this chapter.
    (2) A CLIA-exempt laboratory is subject to appropriate enforcement 
actions under the approved State licensure program.
    (d) Compliance with basic inspection requirements. CLIA-exempt 
laboratories and laboratories requesting or issued a certificate of 
accreditation must comply with the basic inspection requirements in 
Sec. 493.1773.

[63 FR 26738, May 14, 1998]



                    Subpart R_Enforcement Procedures

    Source: 57 FR 7237, Feb. 28, 1992, unless otherwise noted.



Sec. 493.1800  Basis and scope.

    (a) Statutory basis. (1) Section 1846 of the Act--
    (i) Provides for intermediate sanctions that may be imposed on 
laboratories that perform clinical diagnostic tests on human specimens 
when those laboratories are found to be out of compliance with one or 
more of the conditions for Medicare coverage of their services; and
    (ii) Requires the Secretary to develop and implement a range of such 
sanctions, including four that are specified in the statute.
    (2) The Clinical Laboratory Improvement Act of 1967 (section 353 of 
the Public Health Service Act) as amended by CLIA 1988, as amended by 
section 2 of the Taking Essential Steps for Testing Act of 2012--
    (i) Establishes requirements for all laboratories that perform 
clinical diagnostic tests on human specimens;
    (ii) Requires a Federal certification scheme to be applied to all 
such laboratories; and
    (iii) Grants the Secretary broad enforcement authority, including--
    (A) Use of intermediate sanctions;
    (B) Suspension, limitation, or revocation of the certificate of a 
laboratory that is out of compliance with one or more requirements for a 
certificate; and
    (C) Civil suit to enjoin any laboratory activity that constitutes a 
significant hazard to the public health.
    (3) Section 353 also--
    (i) Provides for imprisonment or fine for any person convicted of 
intentional violation of CLIA requirements;

[[Page 743]]

    (ii) Specifies the administrative hearing and judicial review rights 
of a laboratory that is sanctioned under CLIA; and
    (iii) Requires the Secretary to publish annually a list of all 
laboratories that have been sanctioned during the preceding year.
    (b) Scope and applicability. This subpart sets forth--
    (1) The policies and procedures that CMS follows to enforce the 
requirements applicable to laboratories under CLIA and under section 
1846 of the Act; and
    (2) The appeal rights of laboratories on which CMS imposes 
sanctions.

[57 FR 7237, Feb. 28, 1992, as amended at 79 FR 25480, May 2, 2014]



Sec. 493.1804  General considerations.

    (a) Purpose. The enforcement mechanisms set forth in this subpart 
have the following purposes:
    (1) To protect all individuals served by laboratories against 
substandard testing of specimens.
    (2) To safeguard the general public against health and safety 
hazards that might result from laboratory activities.
    (3) To motivate laboratories to comply with CLIA requirements so 
that they can provide accurate and reliable test results.
    (b) Basis for decision to impose sanctions. (1) CMS's decision to 
impose sanctions is based on one or more of the following:
    (i) Deficiencies found by CMS or its agents in the conduct of 
inspections to certify or validate compliance with Federal requirements, 
or through review of materials submitted by the laboratory (e.g., 
personnel qualifications).
    (ii) Unsuccessful participation in proficiency testing.
    (2) CMS imposes one or more of the alternative or principal 
sanctions specified in Sec. Sec. 493.1806 and 493.1807 when CMS or 
CMS's agent finds that a laboratory has condition-level deficiencies.
    (c) Imposition of alternative sanctions. (1) CMS may impose 
alternative sanctions in lieu of, or in addition to principal sanctions. 
(Except for a condition level deficiency under Sec. Sec. 493.41 or 
493.1100(a), CMS does not impose alternative sanctions on laboratories 
that have certificates of waiver because those laboratories are not 
routinely inspected for compliance with condition-level requirements.)
    (2) CMS may impose alternative sanctions other than a civil money 
penalty after the laboratory has had an opportunity to respond, but 
before the hearing specified in Sec. 493.1844.
    (d) Choice of sanction: Factors considered. CMS bases its choice of 
sanction or sanctions on consideration of one or more factors that 
include, but are not limited to, the following, as assessed by the State 
or by CMS, or its agents:
    (1) Whether the deficiencies pose immediate jeopardy.
    (2) The nature, incidence, severity, and duration of the 
deficiencies or noncompliance.
    (3) Whether the same condition level deficiencies have been 
identified repeatedly.
    (4) The accuracy and extent of laboratory records (e.g., of remedial 
action) in regard to the noncompliance, and their availability to the 
State, to other CMS agents, and to CMS.
    (5) The relationship of one deficiency or group of deficiencies to 
other deficiencies.
    (6) The overall compliance history of the laboratory including but 
not limited to any period of noncompliance that occurred between 
certifications of compliance.
    (7) The corrective and long-term compliance outcomes that CMS hopes 
to achieve through application of the sanction.
    (8) Whether the laboratory has made any progress toward improvement 
following a reasonable opportunity to correct deficiencies.
    (9) Any recommendation by the State agency as to which sanction 
would be appropriate.
    (e) Number of alternative sanctions. CMS may impose a separate 
sanction for each condition level deficiency or a single sanction for 
all condition level deficiencies that are interrelated and subject to 
correction by a single course of action.

[[Page 744]]

    (f) Appeal rights. The appeal rights of laboratories dissatisfied 
with the imposition of a sanction are set forth in Sec. 493.1844.

[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992, as amended at 60 
FR 20051, Apr. 24, 1995; 85 FR 54874, Sept. 2, 2020]



Sec. 493.1806  Available sanctions: All laboratories.

    (a) Applicability. CMS may impose one or more of the sanctions 
specified in this section on a laboratory that is out of compliance with 
one or more CLIA conditions.
    (b) Principal sanction. CMS may impose any of the three principal 
CLIA sanctions, which are suspension, limitation, or revocation of any 
type of CLIA certificate.
    (c) Alternative sanctions. CMS may impose one or more of the 
following alternative sanctions in lieu of or in addition to imposing a 
principal sanction, except on a laboratory that has a certificate of 
waiver.
    (1) Directed plan of correction, as set forth at Sec. 493.1832.
    (2) State onsite monitoring as set forth at Sec. 493.1836.
    (3) Civil money penalty, as set forth at Sec. 493.1834.
    (d) Civil suit. CMS may bring suit in the appropriate U.S. District 
Court to enjoin continuation of any activity of any laboratory 
(including a CLIA-exempt laboratory that has been found with 
deficiencies during a validation survey), if CMS has reason to believe 
that continuation of the activity would constitute a significant hazard 
to the public health.
    (e) Criminal sanctions. Under section 353(1) of the PHS Act, an 
individual who is convicted of intentionally violating any CLIA 
requirement may be imprisoned or fined.

[57 FR 7237, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993]



Sec. 493.1807  Additional sanctions: Laboratories that participate 
in Medicare.

    The following additional sanctions are available for laboratories 
that are out of compliance with one or more CLIA conditions and that 
have approval to receive Medicare payment for their services.
    (a) Principal sanction. Cancellation of the laboratory's approval to 
receive Medicare payment for its services.
    (b) Alternative sanctions. (1) Suspension of payment for tests in 
one or more specific specialties or subspecialties, performed on or 
after the effective date of sanction.
    (2) Suspension of payment for all tests in all specialties and 
subspecialties performed on or after the effective date of sanction.



Sec. 493.1808  Adverse action on any type of CLIA certificate: Effect
on Medicare approval.

    (a) Suspension or revocation of any type of CLIA certificate. When 
CMS suspends or revokes any type of CLIA certificate, CMS concurrently 
cancels the laboratory's approval to receive Medicare payment for its 
services.
    (b) Limitation of any type of CLIA certificate. When CMS limits any 
type of CLIA certificate, CMS concurrently limits Medicare approval to 
only those specialties or subspecialties that are authorized by the 
laboratory's limited certificate.



Sec. 493.1809  Limitation on Medicaid payment.

    As provided in section 1902(a)(9)(C) of the Act, payment for 
laboratory services may be made under the State plan only if those 
services are furnished by a laboratory that has a CLIA certificate or is 
licensed by a State whose licensure program has been approved by the 
Secretary under this part.

[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992]



Sec. 493.1810  Imposition and lifting of alternative sanctions.

    (a) Notice of noncompliance and of proposed sanction: Content. If 
CMS or its agency identifies condition level noncompliance in a 
laboratory, CMS or its agent gives the laboratory written notice of the 
following:
    (1) The condition level noncompliance that it has identified.
    (2) The sanction or sanctions that CMS or its agent proposes to 
impose against the laboratory.
    (3) The rationale for the proposed sanction or sanctions.

[[Page 745]]

    (4) The projected effective date and duration of the proposed 
sanction or sanctions.
    (5) The authority for the proposed sanction or sanctions.
    (6) The time allowed (at least 10 days) for the laboratory to 
respond to the notice.
    (b) Opportunity to respond. During the period specified in paragraph 
(a)(6) of this section, the laboratory may submit to CMS or its agent 
written evidence or other information against the imposition of the 
proposed sanction or sanctions.
    (c) Notice of imposition of sanction--(1) Content. CMS gives the 
laboratory written notice that acknowledges any evidence or information 
received from the laboratory and specifies the following:
    (i) The sanction or sanctions to be imposed against the laboratory.
    (ii) The authority and rationale for the imposing sanction or 
sanctions.
    (iii) The effective date and duration of sanction.
    (2) Timing. (i) If CMS or its agent determines that the deficiencies 
pose immediate jeopardy, CMS provides notice at least 5 days before the 
effective date of sanction.
    (ii) If CMS or its agent determines that the deficiencies do not 
pose immediate jeopardy, CMS provides notice at least 15 days before the 
effective date of the sanction.
    (d) Duration of alternative sanctions. An alternative sanction 
continues until the earlier of the following occurs:
    (1) The laboratory corrects all condition level deficiencies.
    (2) CMS's suspension, limitation, or revocation of the laboratory's 
CLIA certificate becomes effective.
    (e) Lifting of alternative sanctions--(1) General rule. Alternative 
sanctions are not lifted until a laboratory's compliance with all 
condition level requirements is verified.
    (2) Credible allegation of compliance. When a sanctioned laboratory 
submits a credible allegation of compliance, CMS's agent determines 
whether--
    (i) It can certify compliance on the basis of the evidence presented 
by the laboratory in its allegation; or
    (ii) It must revisit to verify whether the laboratory has, in fact, 
achieved compliance.
    (3) Compliance achieved before the date of revisit. If during a 
revisit, the laboratory presents credible evidence (as determined by CMS 
or its agent) that it achieved compliance before the date of revisit, 
sanctions are lifted as of that earlier date.



Sec. 493.1812  Action when deficiencies pose immediate jeopardy.

    If a laboratory's deficiencies pose immediate jeopardy, the 
following rules apply:
    (a) CMS requires the laboratory to take immediate action to remove 
the jeopardy and may impose one or more alternative sanctions to help 
bring the laboratory into compliance.
    (b) If the findings of a revisit indicate that a laboratory has not 
eliminated the jeopardy, CMS suspends or limits the laboratory's CLIA 
certificate no earlier than 5 days after the date of notice of 
suspension or limitation. CMS may later revoke the certificate.
    (c) In addition, if CMS has reason to believe that the continuation 
of any activity by any laboratory (either the entire laboratory 
operation or any specialty or subspecialty of testing) would constitute 
a significant hazard to the public health, CMS may bring suit and seek a 
temporary injunction or restraining order against continuation of that 
activity by the laboratory, regardless of the type of CLIA certificate 
the laboratory has and of whether it is State-exempt.



Sec. 493.1814  Action when deficiencies are at the condition level
but do not pose immediate jeopardy.

    If a laboratory has condition level deficiencies that do not pose 
immediate jeopardy, the following rules apply:
    (a) Initial action. (1) CMS may cancel the laboratory's approval to 
receive Medicare payment for its services.
    (2) CMS may suspend, limit, or revoke the laboratory's CLIA 
certificate.
    (3) If CMS does not impose a principal sanction under paragraph 
(a)(1) or (a)(2) of this section, it imposes one or more alternative 
sanctions. In the case of unsuccessful participation in proficiency 
testing, CMS may impose the

[[Page 746]]

training and technical assistance requirement set forth at Sec. 
493.1838 in lieu of, or in addition to, one or more alternative 
sanctions.
    (b) Failure to correct condition level deficiencies. If CMS imposes 
alternative sanctions for condition level deficiencies that do not pose 
immediate jeopardy, and the laboratory does not correct the condition 
level deficiencies within 12 months after the last day of inspection, 
CMS--
    (1) Cancels the laboratory's approval to receive Medicare payment 
for its services, and discontinues the Medicare payment sanctions as of 
the day cancellation is effective.
    (2) Following a revisit which indicates that the laboratory has not 
corrected its condition level deficiencies, notifies the laboratory that 
it proposes to suspend, limit, or revoke the certificate, as specified 
in Sec. 493.1816(b), and the laboratory's right to hearing; and
    (3) May impose (or continue, if already imposed) any alternative 
sanctions that do not pertain to Medicare payments. (Sanctions imposed 
under the authority of section 353 of the PHS Act may continue for more 
than 12 months from the last date of inspection, while a hearing on the 
proposed suspension, limitation, or revocation of the certificate of 
compliance, registration certificate, certificate of accreditation, or 
certificate for PPM procedures is pending.)
    (c) Action after hearing. If a hearing decision upholds a proposed 
suspension, limitation, or revocation of a laboratory's CLIA 
certificate, CMS discontinues any alternative sanctions as of the day it 
makes the suspension, limitation, or revocation effective.

[57 FR 7237, Feb. 28, 1992, as amended at 60 FR 20051, Apr. 24, 1995]



Sec. 493.1816  Action when deficiencies are not at the condition level.

    If a laboratory has deficiencies, that are not at the condition 
level, the following rules apply:
    (a) Initial action. The laboratory must submit a plan of correction 
that is acceptable to CMS in content and time frames.
    (b) Failure to correct deficiencies. If, on revisit, it is found 
that the laboratory has not corrected the deficiencies within 12 months 
after the last day of inspection, the following rules apply:
    (1) CMS cancels the laboratory's approval to receive Medicare 
payment for its services.
    (2) CMS notifies the laboratory of its intent to suspend, limit, or 
revoke the laboratory's CLIA certificate and of the laboratory's right 
to a hearing.



Sec. 493.1820  Ensuring timely correction of deficiencies.

    (a) Timing of visits. CMS, the State survey agency or other CMS 
agent may visit the laboratory at any time to evaluate progress, and at 
the end of the period to determine whether all corrections have been 
made.
    (b) Deficiencies corrected before a visit. If during a visit, a 
laboratory produces credible evidence that it achieved compliance before 
the visit, the sanctions are lifted as of that earlier date.
    (c) Failure to correct deficiencies. If during a visit it is found 
that the laboratory has not corrected its deficiencies, CMS may propose 
to suspend, limit, or revoke the laboratory's CLIA certificate.
    (d) Additional time for correcting lower level deficiencies not at 
the condition level. If at the end of the plan of correction period all 
condition level deficiencies have been corrected, and there are 
deficiencies, that are not at the condition level, CMS may request a 
revised plan of correction. The revised plan may not extend beyond 12 
months from the last day of the inspection that originally identified 
the cited deficiencies.
    (e) Persistence of deficiencies. If at the end of the period covered 
by the plan of correction, the laboratory still has deficiencies, the 
rules of Sec. Sec. 493.1814 and 493.1816 apply.



Sec. 493.1826  Suspension of part of Medicare payments.

    (a) Application. (1) CMS may impose this sanction if a laboratory--
    (i) Is found to have condition level deficiencies with respect to 
one or more specialties or subspecialties of tests; and

[[Page 747]]

    (ii) Agrees (in return for not having its Medicare approval 
cancelled immediately) not to charge Medicare beneficiaries or their 
private insurance carriers for the services for which Medicare payment 
is suspended.
    (2) CMS suspends Medicare payment for those specialities or 
subspecialties of tests for which the laboratory is out of compliance 
with Federal requirements.
    (b) Procedures. Before imposing this sanction, CMS provides notice 
of sanction and opportunity to respond in accordance with Sec. 
493.1810.
    (c) Duration and effect of sanction. This sanction continues until 
the laboratory corrects the condition level deficiencies or CMS cancels 
the laboratory's approval to receive Medicare payment for its services, 
but in no event longer than 12 months.
    (1) If the laboratory corrects all condition level deficiencies, CMS 
resumes Medicare payment effective for all services furnished on or 
after the date the deficiencies are corrected.
    (2) [Reserved]

[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992]



Sec. 493.1828  Suspension of all Medicare payments.

    (a) Application. (1) CMS may suspend payment for all Medicare-
approved laboratory services when the laboratory has condition level 
deficiencies.
    (2) CMS suspends payment for all Medicare covered laboratory 
services when the following conditions are met:
    (i) Either--
    (A) The laboratory has not corrected its condition level 
deficiencies included in the plan of correction within 3 months from the 
last date of inspection; or
    (B) The laboratory has been found to have the same condition level 
deficiencies during three consecutive inspections; and
    (ii) The laboratory has chosen (in return for not having its 
Medicare approval immediately cancelled), to not charge Medicare 
beneficiaries or their private insurance carriers for services for which 
Medicare payment is suspended.
    (3) CMS suspends payment for services furnished on and after the 
effective date of sanction.
    (b) Procedures. Before imposing this sanction, CMS provides notice 
of sanction and opportunity to respond in accordance with Sec. 
493.1810.
    (c) Duration and effect of sanction. (1) Suspension of payment 
continues until all condition level deficiencies are corrected, but 
never beyond twelve months.
    (2) If all the deficiencies are not corrected by the end of the 12 
month period, CMS cancels the laboratory's approval to receive Medicare 
payment for its services.



Sec. 493.1832  Directed plan of correction and directed portion of
a plan of correction.

    (a) Application. CMS may impose a directed plan of correction as an 
alternative sanction for any laboratory that has condition level 
deficiencies. If CMS does not impose a directed plan of correction as an 
alternative sanction for a laboratory that has condition level 
deficiencies, it at least imposes a directed portion of a plan of 
correction when it imposes any of the following alternative sanctions:
    (1) State onsite monitoring.
    (2) Civil money penalty.
    (3) Suspension of all or part of Medicare payments.
    (b) Procedures--(1) Directed plan of correction. When imposing this 
sanction, CMS--
    (i) Gives the laboratory prior notice of the sanction and 
opportunity to respond in accordance with Sec. 493.1810;
    (ii) Directs the laboratory to take specific corrective action 
within specific time frames in order to achieve compliance; and
    (iii) May direct the laboratory to submit the names of laboratory 
clients for notification purposes, as specified in paragraph (b)(3) of 
this section.
    (2) Directed portion of a plan of correction. CMS may decide to 
notify clients of a sanctioned laboratory, because of the seriousness of 
the noncompliance (e.g., the existence of immediate jeopardy) or for 
other reasons. When imposing this sanction, CMS takes the following 
steps--

[[Page 748]]

    (i) Directs the laboratory to submit to CMS, the State survey 
agency, or other CMS agent, within 10 calendar days after the notice of 
the alternative sanction, a list of names and addresses of all 
physicians, providers, suppliers, and other clients who have used some 
or all of the services of the laboratory since the last certification 
inspection or within any other timeframe specified by CMS.
    (ii) Within 30 calendar days of receipt of the information, may send 
to each laboratory client, via the State survey agency, a notice 
containing the name and address of the laboratory, the nature of the 
laboratory's noncompliance, and the kind and effective date of the 
alternative sanction.
    (iii) Sends to each laboratory client, via the State survey agency, 
notice of the recission of an adverse action within 30 days of the 
rescission.
    (3) Notice of imposition of a principal sanction following the 
imposition of an alternative sanction. If CMS imposes a principal 
sanction following the imposition of an alternative sanction, and for 
which CMS has already obtained a list of laboratory clients, CMS may use 
that list to notify the clients of the imposition of the principal 
sanction.
    (c) Duration of a directed plan of correction. If CMS imposes a 
directed plan of correction, and on revisit it is found that the 
laboratory has not corrected the deficiencies within 12 months from the 
last day of inspection, the following rules apply:
    (1) CMS cancels the laboratory's approval for Medicare payment of 
its services, and notifies the laboratory of CMS's intent to suspend, 
limit, or revoke the laboratory's CLIA certificate.
    (2) The directed plan of correction continues in effect until the 
day suspension, limitation, or revocation of the laboratory's CLIA 
certificate.



Sec. 493.1834  Civil money penalty.

    (a) Statutory basis. Sections 1846 of the Act and 353(h)(2)(B) of 
the PHS Act authorize the Secretary to impose civil money penalties on 
laboratories. Section 1846(b)(3) of the Act specifically provides that 
incrementally more severe fines may be imposed for repeated or 
uncorrected deficiencies.
    (b) Scope. This section sets forth the procedures that CMS follows 
to impose a civil money penalty in lieu of, or in addition to, 
suspending, limiting, or revoking the certificate of compliance, 
registration certificate, certificate of accreditation, or certificate 
for PPM procedures of a laboratory that is found to have condition level 
deficiencies.
    (c) Basis for imposing a civil money penalty. CMS may impose a civil 
money penalty against any laboratory determined to have condition level 
deficiencies regardless of whether those deficiencies pose immediate 
jeopardy.
    (d) Amount of penalty--(1) Factors considered. In determining the 
amount of the penalty, CMS takes into account the following factors:
    (i) The nature, scope, severity, and duration of the noncompliance.
    (ii) Whether the same condition level deficiencies have been 
identified during three consecutive inspections.
    (iii) The laboratory's overall compliance history including but not 
limited to any period of noncompliance that occurred between 
certifications of compliance.
    (iv) The laboratory's intent or reason for noncompliance.
    (v) The accuracy and extent of laboratory records and their 
availability to CMS, the State survey agency, or other CMS agent.
    (2) Range of penalty amount. (i) For a condition level deficiency 
that poses immediate jeopardy, the range is $3,050-$10,000 as adjusted 
annually under 45 CFR part 102 per day of noncompliance or per 
violation.
    (ii) For a condition level deficiency that does not pose immediate 
jeopardy, the range is $50-$3,000 as adjusted annually under 45 CFR part 
102 per day of noncompliance or per violation.
    (iii) For a condition level deficiency under Sec. Sec. 493.41 or 
493.1100(a), the penalty amount is $1,000 for the first day of 
noncompliance and $500 for each additional day of noncompliance.
    (3) Decreased penalty amounts. If the immediate jeopardy is removed, 
but the deficiency continues, CMS shifts the penalty amount to the lower 
range.

[[Page 749]]

    (4) Increased penalty amounts. CMS may, before the hearing, propose 
to increase the penalty amount for a laboratory that has deficiencies 
which, after imposition of a lower level penalty amount, become 
sufficiently serious to pose immediate jeopardy.
    (e) Procedures for imposition of civil money penalty--(1) Notice of 
intent. (i) CMS sends the laboratory written notice, of CMS's intent to 
impose a civil money penalty.
    (ii) The notice includes the following information:
    (A) The statutory basis for the penalty.
    (B) The proposed daily or per violation amount of the penalty.
    (C) The factors (as described in paragraph (d)(1) of this section) 
that CMS considered.
    (D) The opportunity for responding to the notice in accordance with 
Sec. 493.1810(c).
    (E) A specific statement regarding the laboratory's appeal rights.
    (2) Appeal rights. (i) The laboratory has 60 days from the date of 
receipt of the notice of intent to impose a civil money penalty to 
request a hearing in accordance with Sec. 493.1844(g).
    (ii) If the laboratory requests a hearing, all other pertinent 
provisions of Sec. 493.1844 apply.
    (iii) If the laboratory does not request a hearing, CMS may reduce 
the proposed penalty amount by 35 percent.
    (f) Accrual and duration of penalty--(1) Accrual of penalty. The 
civil money penalty begins accruing as follows:
    (i) 5 days after notice of intent if there is immediate jeopardy.
    (ii) 15 days after notice of intent if there is not immediate 
jeopardy.
    (2) Duration of penalty. The civil money penalty continues to accrue 
until the earliest of the following occurs:
    (i) The laboratory's compliance with condition level requirements is 
verified on the basis of the evidence presented by the laboratory in its 
credible allegation of compliance or at the time or revisit.
    (ii) Based on credible evidence presented by the laboratory at the 
time of revisit, CMS determines that compliance was achieved before the 
revisit. (In this situation, the money penalty stops accruing as of the 
date of compliance.)
    (iii) CMS suspends, limits, or revokes the laboratory's certificate 
of compliance, registration certificate, certificate of accreditation, 
or certificate for PPM procedures.
    (g) Computation and notice of total penalty amount--(1) Computation. 
CMS computes the total penalty amount after the laboratory's compliance 
is verified or CMS suspends, limits, or revokes the laboratory's CLIA 
certificate but in no event before--
    (i) The 60 day period for requesting a hearing has expired without a 
request or the laboratory has explicitly waived its right to a hearing; 
or
    (ii) Following a hearing requested by the laboratory, the ALJ issues 
a decision that upholds imposition of the penalty.
    (2) Notice of penalty amount and due date of penalty. The notice 
includes the following information:
    (i) Daily or per violation penalty amount.
    (ii) Number of days or violations for which the penalty is imposed.
    (iii) Total penalty amount.
    (iv) Due date for payment of the penalty.
    (h) Due date for payment of penalty. (1) Payment of a civil money 
penalty is due 15 days from the date of the notice specified in 
paragraph (g)(2) of this section.
    (2) CMS may approve a plan for a laboratory to pay a civil money 
penalty, plus interest, over a period of up to one year from the 
original due date.
    (i) Collection and settlement--(1) Collection of penalty amounts. 
(i) The determined penalty amount may be deducted from any sums then or 
later owing by the United States to the laboratory subject to the 
penalty.
    (ii) Interest accrues on the unpaid balance of the penalty, 
beginning on the due date. Interest is computed at the rate specified in 
Sec. 405.378(d) of this chapter.
    (2) Settlement. CMS has authority to settle any case at any time 
before the ALJ issues a hearing decision.

[57 FR 7237, Feb. 28, 1992, as amended at 60 FR 20051, Apr. 24, 1995; 61 
FR 63749, Dec. 2, 1996; 81 FR 61564, Sept. 6, 2016; 85 FR 54874, Sept. 
2, 2020]

[[Page 750]]



Sec. 493.1836  State onsite monitoring.

    (a) Application. (1) CMS may require continuous or intermittent 
monitoring of a plan of correction by the State survey agency to ensure 
that the laboratory makes the improvements necessary to bring it into 
compliance with the condition level requirements. (The State monitor 
does not have management authority, that is, cannot hire or fire staff, 
obligate funds, or otherwise dictate how the laboratory operates. The 
monitor's responsibility is to oversee whether corrections are made.)
    (2) The laboratory must pay the costs of onsite monitoring by the 
State survey agency.
    (i) The costs are computed by multiplying the number of hours of 
onsite monitoring in the laboratory by the hourly rate negotiated by CMS 
and the State.
    (ii) The hourly rate includes salary, fringe benefits, travel, and 
other direct and indirect costs approved by CMS.
    (b) Procedures. Before imposing this sanction, CMS provides notice 
of sanction and opportunity to respond in accordance with Sec. 
493.1810.
    (c) Duration of sanction. (1) If CMS imposes onsite monitoring, the 
sanction continues until CMS determines that the laboratory has the 
capability to ensure compliance with all condition level requirements.
    (2) If the laboratory does not correct all deficiencies within 12 
months, and a revisit indicates that deficiencies remain, CMS cancels 
the laboratory's approval for Medicare payment for its services and 
notifies the laboratory of its intent to suspend, limit, or revoke the 
laboratory's certificate of compliance, registration certificate, 
certificate of accreditation, or certificate for PPM procedures.
    (3) If the laboratory still does not correct its deficiencies, the 
Medicare sanction continues until the suspension, limitation, or 
revocation of the laboratory's certificate of compliance, registration 
certificate, certificate of accreditation, or certificate for PPM 
procedures is effective.

[57 FR 7237, Feb. 28, 1992, as amended at 60 FR 20051, Apr. 24, 1995]



Sec. 493.1838  Training and technical assistance for unsuccessful
participation in proficiency testing.

    If a laboratory's participation in proficiency testing is 
unsuccessful, CMS may require the laboratory to undertake training of 
its personnel, or to obtain necessary technical assistance, or both, in 
order to meet the requirements of the proficiency testing program. This 
requirement is separate from the principal and alternative sanctions set 
forth in Sec. Sec. 493.1806 and 493.1807.



Sec. 493.1840  Suspension, limitation, or revocation of any type 
of CLIA certificate.

    (a) Adverse action based on actions of the laboratory's owner, 
operator or employees. CMS may initiate adverse action to suspend, limit 
or revoke any CLIA certificate if CMS finds that a laboratory's owner or 
operator or one of its employees has--
    (1) Been guilty of misrepresentation in obtaining a CLIA 
certificate;
    (2) Performed, or represented the laboratory as entitled to perform, 
a laboratory examination or other procedure that is not within a 
category of laboratory examinations or other procedures authorized by 
its CLIA certificate;
    (3) Failed to comply with the certificate requirements and 
performance standards;
    (4) Failed to comply with reasonable requests by CMS for any 
information or work on materials that CMS concludes is necessary to 
determine the laboratory's continued eligibility for its CLIA 
certificate or continued compliance with performance standards set by 
CMS;
    (5) Refused a reasonable request by CMS or its agent for permission 
to inspect the laboratory and its operation and pertinent records during 
the hours that the laboratory is in operation;
    (6) Violated or aided and abetted in the violation of any provisions 
of CLIA and its implementing regulations;
    (7) Failed to comply with an alternative sanction imposed under this 
subpart; or
    (8) Within the preceding two-year period, owned or operated a 
laboratory that had its CLIA certificate revoked.

[[Page 751]]

(This provision applies only to the owner or operator, not to all of the 
laboratory's employees.)
    (b) Adverse action based on improper referrals in proficiency 
testing. If CMS determines that a laboratory has intentionally referred 
its proficiency testing samples to another laboratory for analysis, CMS 
does one of the following:
    (1)(i) Revokes the laboratory's CLIA certificate for at least 1 
year, prohibits the owner and operator from owning or operating a CLIA-
certified laboratory for at least 1 year, and may impose a civil money 
penalty in accordance with Sec. 493.1834(d), if CMS determines that--
    (A) A proficiency testing referral is a repeat proficiency testing 
referral as defined at Sec. 493.2; or
    (B) On or before the proficiency testing event close date, a 
laboratory reported proficiency testing results obtained from another 
laboratory to the proficiency testing program.
    (ii) Following the revocation of a CLIA certificate in accordance 
with paragraph (b)(1)(i) of this section, CMS may exempt a laboratory 
owner from the generally applicable prohibition on owning or operating a 
CLIA-certified laboratory under paragraph (a)(8) of this section on a 
laboratory-by-laboratory basis if CMS finds, after review of the 
relevant facts and circumstances, that there is no evidence that--
    (A) Patients would be put at risk as a result of the owner being 
exempted from the ban on a laboratory-by-laboratory basis;
    (B) The laboratory for which the owner is to be exempted from the 
general ownership ban participated in or was otherwise complicit in the 
PT referral of the laboratory that resulted in the revocation; and
    (C) The laboratory for which the owner is to be exempted from the 
general ownership ban received a PT sample from another laboratory in 
the prior two survey cycles, and failed to immediately report such 
receipt to CMS or to the appropriate CMS-approved accrediting 
organization.
    (2) Suspends or limits the CLIA certificate for less than 1 year 
based on the criteria in Sec. 493.1804(d) and imposes alternative 
sanctions as appropriate, in accordance with Sec. Sec. 493.1804(c) and 
(d), 493.1806(c), 493.1807(b), 493.1809 and, in the case of civil money 
penalties, Sec. 493.1834(d), when CMS determines that paragraph 
(b)(1)(i)(A) or (B) of this section does not apply but that the 
laboratory obtained test results for the proficiency testing samples 
from another laboratory on or before the proficiency testing event close 
date. Among other possibilities, alternative sanctions will always 
include a civil money penalty and a directed plan of correction that 
includes required training of staff.
    (3) Imposes alternative sanctions in accordance with Sec. Sec. 
493.1804(c) and (d), 493.1806(c), 493.1807(b), 493.1809 and, in the case 
of civil money penalties, Sec. 493.1834(d), when CMS determines that 
paragraph (b)(1)(i) or (2) of this section do not apply, and a PT 
referral has occurred, but no test results are received prior to the 
event close date by the referring laboratory from the laboratory that 
received the referral. Among other possibilities, alternative sanctions 
will always include a civil money penalty and a directed plan of 
correction that includes required training of staff.
    (c) Adverse action based on exclusion from Medicare. If the OIG 
excludes a laboratory from participation in Medicare, CMS suspends the 
laboratory's CLIA certificate for the period during which the laboratory 
is excluded.
    (d) Procedures for suspension or limitation--(1) Basic rule. Except 
as provided in paragraph (d)(2) of this section, CMS does not suspend or 
limit a CLIA certificate until after an ALJ hearing decision (as 
provided in Sec. 493.1844) that upholds suspension or limitation.
    (2) Exceptions. CMS may suspend or limit a CLIA certificate before 
the ALJ hearing in any of the following circumstances:
    (i) The laboratory's deficiencies pose immediate jeopardy.
    (ii) The laboratory has refused a reasonable request for information 
or work on materials.
    (iii) The laboratory has refused permission for CMS or a CMS agent 
to inspect the laboratory or its operation.
    (e) Procedures for revocation. (1) CMS does not revoke any type of 
CLIA certificate until after an ALJ hearing that upholds revocation.
    (2) CMS may revoke a CLIA certificate after the hearing decision 
even if

[[Page 752]]

it had not previously suspended or limited that certificate.
    (f) Notice to the OIG. CMS notifies the OIG of any violations under 
paragraphs (a)(1), (a)(2), (a)(6), and (b) of this section within 30 
days of the determination of the violation.

[57 FR 7237, Feb. 28, 1992, as amended at 79 FR 25480, May 2, 2014]



Sec. 493.1842  Cancellation of Medicare approval.

    (a) Basis for cancellation. (1) CMS always cancels a laboratory's 
approval to receive Medicare payment for its services if CMS suspends or 
revokes the laboratory's CLIA certificate.
    (2) CMS may cancel the laboratory's approval under any of the 
following circumstances:
    (i) The laboratory is out of compliance with a condition level 
requirement.
    (ii) The laboratory fails to submit a plan of correction 
satisfactory to CMS.
    (iii) The laboratory fails to correct all its deficiencies within 
the time frames specified in the plan of correction.
    (b) Notice and opportunity to respond. Before canceling a 
laboratory's approval to receive Medicare payment for its services, CMS 
gives the laboratory--
    (1) Written notice of the rationale for, effective date, and effect 
of, cancellation;
    (2) Opportunity to submit written evidence or other information 
against cancellation of the laboratory's approval.
    This sanction may be imposed before the hearing that may be 
requested by a laboratory, in accordance with the appeals procedures set 
forth in Sec. 493.1844.
    (c) Effect of cancellation. Cancellation of Medicare approval 
terminates any Medicare payment sanctions regardless of the time frames 
originally specified.



Sec. 493.1844  Appeals procedures.

    (a) General rules. (1) The provisions of this section apply to all 
laboratories and prospective laboratories that are dissatisfied with any 
initial determination under paragraph (b) of this section.
    (2) Hearings are conducted in accordance with procedures set forth 
in subpart D of part 498 of this chapter, except that the authority to 
conduct hearings and issue decisions may be exercised by ALJs assigned 
to, or detailed to, the Departmental Appeals Board.
    (3) Any party dissatisfied with a hearing decision is entitled to 
request review of the decision as specified in subpart E of part 498 of 
this chapter, except that the authority to review the decision may be 
exercised by the Departmental Appeals Board.
    (4) When more than one of the actions specified in paragraph (b) of 
this section are carried out concurrently, the laboratory has a right to 
only one hearing on all matters at issue.
    (b) Actions that are initial determinations. The following actions 
are initial determinations and therefore are subject to appeal in 
accordance with this section:
    (1) The suspension, limitation, or revocation of the laboratory's 
CLIA certificate by CMS because of noncompliance with CLIA requirements.
    (2) The denial of a CLIA certificate.
    (3) The imposition of alternative sanctions under this subpart (but 
not the determination as to which alternative sanction or sanctions to 
impose).
    (4) The denial or cancellation of the laboratory's approval to 
receive Medicare payment for its services.
    (c) Actions that are not initial determinations. Actions that are 
not listed in paragraph (b) of this section are not initial 
determinations and therefore are not subject to appeal under this 
section. They include, but are not necessarily limited to, the 
following:
    (1) The finding that a laboratory accredited by a CMS-approved 
accreditation organization is no longer deemed to meet the conditions 
set forth in subparts H, J, K, M, and Q of this part. However, the 
suspension, limitation or revocation of a certificate of accreditation 
is an initial determination and is appealable.
    (2) The finding that a laboratory determined to be in compliance 
with condition-level requirements but has deficiencies that are not at 
the condition level.

[[Page 753]]

    (3) The determination not to reinstate a suspended CLIA certificate 
because the reason for the suspension has not been removed or there is 
insufficient assurance that the reason will not recur.
    (4) The determination as to which alternative sanction or sanctions 
to impose, including the amount of a civil money penalty to impose per 
day or per violation.
    (5) The denial of approval for Medicare payment for the services of 
a laboratory that does not have in effect a valid CLIA certificate.
    (6) The determination that a laboratory's deficiencies pose 
immediate jeopardy.
    (7) The amount of the civil money penalty assessed per day or for 
each violation of Federal requirements.
    (d) Effect of pending appeals--(1) Alternative sanctions. The 
effective date of an alternative sanction (other than a civil money 
penalty) is not delayed because the laboratory has appealed and the 
hearing or the hearing decision is pending.
    (2) Suspension, limitation, or revocation of a laboratory's CLIA 
certificate--(i) General rule. Except as provided in paragraph 
(d)(2)(ii) of this section, suspension, limitation, or revocation of a 
CLIA certificate is not effective until after a hearing decision by an 
ALJ is issued.
    (ii) Exceptions. (A) If CMS determines that conditions at a 
laboratory pose immediate jeopardy, the effective date of the suspension 
or limitation of a CLIA certificate is not delayed because the 
laboratory has appealed and the hearing or the hearing decision is 
pending.
    (B) CMS may suspend or limit a laboratory's CLIA certificate before 
an ALJ hearing or hearing decision if the laboratory has refused a 
reasonable request for information (including but not limited to billing 
information), or for work on materials, or has refused permission for 
CMS or a CMS agent to inspect the laboratory or its operation.
    (3) Cancellation of Medicare approval. The effective date of the 
cancellation of a laboratory's approval to receive Medicare payment for 
its services is not delayed because the laboratory has appealed and the 
hearing or hearing decision is pending.
    (4) Effect of ALJ decision. (i) An ALJ decision is final unless, as 
provided in paragraph (a)(3) of this section, one of the parties 
requests review by the Departmental Appeals Board within 60 days, and 
the Board reviews the case and issues a revised decision.
    (ii) If an ALJ decision upholds a suspension imposed because of 
immediate jeopardy, that suspension becomes a revocation.
    (e) Appeal rights for prospective laboratories--(1) Reconsideration. 
Any prospective laboratory dissatisfied with a denial of a CLIA 
certificate, or of approval for Medicare payment for its services, may 
initiate the appeals process by requesting reconsideration in accordance 
with Sec. Sec. 498.22 through 498.25 of this chapter.
    (2) Notice of reopening. If CMS reopens an initial or reconsidered 
determination, CMS gives the prospective laboratory notice of the 
revised determination in accordance with Sec. 498.32 of this chapter.
    (3) ALJ hearing. Any prospective laboratory dissatisfied with a 
reconsidered determination under paragraph (e)(1) of this section or a 
revised reconsidered determination under Sec. 498.30 of this chapter is 
entitled to a hearing before an ALJ, as specified in paragraph (a)(2) of 
this section.
    (4) Review of ALJ hearing decisions. Any prospective laboratory that 
is dissatisfied with an ALJ's hearing decision or dismissal of a request 
for hearing may file a written request for review by the Departmental 
Appeals Board as provided in paragraph (a)(3) of this section.
    (f) Appeal rights of laboratories--(1) ALJ hearing. Any laboratory 
dissatisfied with the suspension, limitation, or revocation of its CLIA 
certificate, with the imposition of an alternative sanction under this 
subpart, or with cancellation of the approval to receive Medicare 
payment for its services, is entitled to a hearing before an ALJ as 
specified in paragraph (a)(2) of this section and has 60 days from the 
notice of sanction to request a hearing.
    (2) Review of ALJ hearing decisions. Any laboratory that is 
dissatisfied

[[Page 754]]

with an ALJ's hearing decision or dismissal of a request for hearing may 
file a written request for review by the Departmental Appeals Board, as 
provided in paragraph (a)(3) of this section.
    (3) Judicial review. Any laboratory dissatisfied with the decision 
to impose a civil money penalty or to suspend, limit, or revoke its CLIA 
certificate may, within 60 days after the decision becomes final, file 
with the U.S. Court of Appeals of the circuit in which the laboratory 
has its principal place of business, a petition for judicial review.
    (g) Notice of adverse action. (1) If CMS suspends, limits, or 
revokes a laboratory's CLIA certificate or cancels the approval to 
receive Medicare payment for its services, CMS gives notice to the 
laboratory, and may give notice to physicians, providers, suppliers, and 
other laboratory clients, according to the procedures set forth at Sec. 
493.1832. In addition, CMS notifies the general public each time one of 
these principal sanctions is imposed.
    (2) The notice to the laboratory--
    (i) Sets forth the reasons for the adverse action, the effective 
date and effect of that action, and the appeal rights if any; and
    (ii) When the certificate is limited, specifies the specialties or 
subspecialties of tests that the laboratory is no longer authorized to 
perform, and that are no longer covered under Medicare.
    (3) The notice to other entities includes the same information 
except the information about the laboratory's appeal rights.
    (h) Effective date of adverse action. (1) When the laboratory's 
deficiencies pose immediate jeopardy, the effective date of the adverse 
action is at least 5 days after the date of the notice.
    (2) When CMS determines that the laboratory's deficiencies do not 
pose immediate jeopardy, the effective date of the adverse action is at 
least 15 days after the date of the notice.

[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992, as amended at 68 
FR 3714, Jan. 24, 2003]



Sec. 493.1846  Civil action.

    If CMS has reason to believe that continuation of the activities of 
any laboratory, including a State-exempt laboratory, would constitute a 
significant hazard to the public health, CMS may bring suit in a U.S. 
District Court to enjoin continuation of the specific activity that is 
causing the hazard or to enjoin the continued operation of the 
laboratory if CMS deems it necessary. Upon proper showing, the court 
shall issue a temporary injunction or restraining order without bond 
against continuation of the activity.



Sec. 493.1850  Laboratory registry.

    (a) Once a year CMS makes available to physicians and to the general 
public specific information (including information provided to CMS by 
the OIG) that is useful in evaluating the performance of laboratories, 
including the following:
    (1) A list of laboratories that have been convicted, under Federal 
or State laws relating to fraud and abuse, false billing, or kickbacks.
    (2) A list of laboratories that have had their CLIA certificates 
suspended, limited, or revoked, and the reason for the adverse actions.
    (3) A list of persons who have been convicted of violating CLIA 
requirements, as specified in section 353(1) of the PHS Act, together 
with the circumstances of each case and the penalties imposed.
    (4) A list of laboratories on which alternative sanctions have been 
imposed, showing--
    (i) The effective date of the sanctions;
    (ii) The reasons for imposing them;
    (iii) Any corrective action taken by the laboratory; and
    (iv) If the laboratory has achieved compliance, the verified date of 
compliance.
    (5) A list of laboratories whose accreditation has been withdrawn or 
revoked and the reasons for the withdrawal or revocation.
    (6) All appeals and hearing decisions.
    (7) A list of laboratories against which CMS has brought suit under 
Sec. 493.1846 and the reasons for those actions.
    (8) A list of laboratories that have been excluded from 
participation in Medicare or Medicaid and the reasons for the exclusion.
    (b) The laboratory registry is compiled for the calendar year 
preceding

[[Page 755]]

the date the information is made available and includes appropriate 
explanatory information to aid in the interpretation of the data. It 
also contains corrections of any erroneous statements or information 
that appeared in the previous registry.

Subpart S [Reserved]



                         Subpart T_Consultations

    Source: 57 FR 7185, Feb. 28, 1992, unless otherwise noted.



Sec. 493.2001  Establishment and function of the Clinical Laboratory 
Improvement Advisory Committee.

    (a) HHS will establish a Clinical Laboratory Improvement Advisory 
Committee to advise and make recommendations on technical and scientific 
aspects of the provisions of this part 493.
    (b) The Clinical Laboratory Improvement Advisory Committee will be 
comprised of individuals involved in the provision of laboratory 
services, utilization of laboratory services, development of laboratory 
testing or methodology, and others as approved by HHS.
    (c) HHS will designate specialized subcommittees as necessary.
    (d) The Clinical Laboratory Improvement Advisory Committee or any 
designated subcommittees will meet as needed, but not less than once 
each year.
    (e) The Clinical Laboratory Improvement Advisory Committee or 
subcommittee, at the request of HHS, will review and make 
recommendations concerning:
    (1) Criteria for categorizing nonwaived testing;
    (2) Determination of waived tests;
    (3) Personnel standards;
    (4) Facility administration and quality systems standards.
    (5) Proficiency testing standards;
    (6) Applicability to the standards of new technology; and
    (7) Other issues relevant to part 493, if requested by HHS.
    (f) HHS will be responsible for providing the data and information, 
as necessary, to the members of the Clinical Laboratory Improvement 
Advisory Committee.

[57 FR 7185, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993; 60 
FR 20051, Apr. 24, 1995; 68 FR 3714, Jan. 24, 2003]



PART 494_CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE
FACILITIES--Table of Contents



                      Subpart A_General Provisions

Sec.
494.1 Basis and scope.
494.10 Definitions.
494.20 Condition: Compliance with Federal, State, and local laws and 
          regulations.

                        Subpart B_Patient Safety

494.30 Condition: Infection control.
494.40 Condition: Water and dialysate quality.
494.50 Condition: Reuse of hemodialyzers and bloodlines.
494.60 Condition: Physical environment.
494.62 Condition of participation: Emergency preparedness.

                         Subpart C_Patient Care

494.70 Condition: Patients' rights.
494.80 Condition: Patient assessment.
494.90 Condition: Patient plan of care.
494.100 Condition: Care at home.
494.110 Condition: Quality assessment and performance improvement.
494.120 Condition: Special purpose renal dialysis facilities.
494.130 Condition: Laboratory services.

                        Subpart D_Administration

494.140 Condition: Personnel qualifications.
494.150 Condition: Responsibilities of the medical director.
494.160 [Reserved]
494.170 Condition: Medical records.
494.180 Condition: Governance.

    Authority: 42 U.S.C. l302 and l395hh.

    Source: 73 FR 20475, Apr. 15, 2008, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 494.1  Basis and scope.

    (a) Statutory basis. This part is based on the following provisions:
    (1) Section 299I of the Social Security Amendments of 1972 (Pub. L. 
92-603), which extended Medicare coverage to insured individuals, their 
spouses, and their dependent children with ESRD

[[Page 756]]

who require dialysis or transplantation.
    (2) Section 1861(e)(9) of the Act, which requires hospitals to meet 
such other requirements as the Secretary finds necessary in the interest 
of health and safety of individuals who are furnished services in the 
institution.
    (3) Section 1861(s)(2)(F) of the Act, which describes ``medical and 
other health services'' covered under Medicare to include home dialysis 
supplies and equipment, self-care home dialysis support services, and 
institutional dialysis services and supplies, for items and services 
furnished on or after January 1, 2011, renal dialysis services (as 
defined in section 1881(b)(14)(B)), including such renal dialysis 
services furnished on or after January 1, 2017, by a renal dialysis 
facility or provider of services paid under section 1881(b)(14) to an 
individual with acute kidney injury (as defined in section 1834(r)(2)).
    (4) Section 1862(a) of the Act, which specifies exclusions from 
coverage.
    (5) Section 1881 of the Act, which authorizes Medicare coverage and 
payment for the treatment of ESRD in approved facilities, including 
institutional dialysis services, transplantation services, self-care 
home dialysis services, and the administration of erythropoiesis-
stimulating agent(s).
    (6) Section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (Pub. L. 104-113), which requires Federal 
agencies to use technical standards that are developed or adopted by 
voluntary consensus standards bodies, unless their use would be 
inconsistent with applicable law or otherwise impractical.
    (7) Section 1861(s)(2)(F) of the Act, which authorizes coverage for 
renal dialysis services furnished on or after January 1, 2017 by a renal 
dialysis facility or provider of services currently paid under section 
1881(b)(14) of the Act to an individual with AKI.
    (b) Scope. The provisions of this part establish the conditions for 
coverage of services under Medicare and are the basis for survey 
activities for the purpose of determining whether an ESRD facility's 
services may be covered.

[73 FR 20475, Apr. 15, 2008, as amended at 81 FR 77969, Nov. 4, 2016]



Sec. 494.10  Definitions.

    As used in this part--
    Dialysis facility means an entity that provides outpatient 
maintenance dialysis services, or home dialysis training and support 
services, or both. A dialysis facility may be an independent or 
hospital-based unit (as described in Sec. 413.174(b) and (c) of this 
chapter) that includes a self-care dialysis unit that furnishes only 
self-dialysis services.
    Discharge means the termination of patient care services by a 
dialysis facility or the patient voluntarily terminating dialysis when 
he or she no longer wants to be dialyzed by that facility.
    Furnishes directly means the ESRD facility provides the service 
through its own staff and employees or through individuals who are under 
direct contract to furnish these services personally for the facility.
    Home dialysis means dialysis performed at home by an ESRD patient or 
caregiver who has completed an appropriate course of training as 
described in Sec. 494.100(a) of this part.
    Self-dialysis means dialysis performed with little or no 
professional assistance by an ESRD patient or caregiver who has 
completed an appropriate course of training as specified in Sec. 
494.100(a) of this part.
    Transfer means a temporary or permanent move of a patient from one 
dialysis facility to another that requires a transmission of the 
patient's medical record to the facility receiving the patient.



Sec. 494.20  Condition: Compliance with Federal, State, and local laws
and regulations.

    The facility and its staff must operate and furnish services in 
compliance with applicable Federal, State, and local laws and 
regulations pertaining to licensure and any other relevant health and 
safety requirements.



                        Subpart B_Patient Safety



Sec. 494.30  Condition: Infection control.

    The dialysis facility must provide and monitor a sanitary 
environment to minimize the transmission of infectious agents within and 
between the

[[Page 757]]

unit and any adjacent hospital or other public areas.
    (a) Standard: Procedures for infection control. The facility must 
demonstrate that it follows standard infection control precautions by 
implementing--
    (1)(i) The recommendations (with the exception of screening for 
hepatitis C), found in ``Recommendations for Preventing Transmission of 
Infections Among Chronic Hemodialysis Patients,'' developed by the 
Centers for Disease Control and Prevention, Morbidity and Mortality 
Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. 
The Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This 
publication is available for inspection at the CMS Information Resource 
Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at 
the National Archives and Records Administration (NARA). Copies may be 
obtained at the CMS Information Resource Center. 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. The recommendation found under section header ``HBV-
Infected Patients'', found on pages 27 and 28 of RR05 (``Recommendations 
for Preventing Transmission of Infections Among Chronic Hemodialysis 
Patients''), concerning isolation rooms, must be complied with by 
February 9, 2009.
    (ii) When dialysis isolation rooms as required by (a)(1)(i) are 
available locally that sufficiently serve the needs of patients in the 
geographic area, a new dialysis facility may request a waiver of such 
requirement. Isolation room waivers may be granted at the discretion of, 
and subject to, additional qualifications as may be deemed necessary by 
the Secretary.
    (2) The ``Guidelines for the Prevention of Intravascular Catheter-
Related Infections'' entitled ``Recommendations for Placement of 
Intravascular Catheters in Adults and Children'' parts I-IV; and 
``Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary 
Artery Catheters, in Adult and Pediatric Patients,'' Morbidity and 
Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, 
August 9, 2002. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. This publication is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Central Building, 
Baltimore, MD or at the National Archives and Records Administration 
(NARA). Copies may be obtained at the CMS Information Resource Center. 
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.
    (3) Patient isolation procedures to minimize the spread of 
infectious agents and communicable diseases; and
    (4) Maintaining procedures, in accordance with applicable State and 
local laws and accepted public health procedures, for the--
    (i) Handling, storage, and disposal of potentially infectious waste; 
and
    (ii) Cleaning and disinfection of contaminated surfaces, medical 
devices, and equipment.
    (b) Standard: Oversight. The facility must--
    (1) Monitor and implement biohazard and infection control policies 
and activities within the dialysis unit;
    (2) Ensure that clinical staff demonstrate compliance with current 
aseptic techniques when dispensing and administering intravenous 
medications from vials and ampules; and
    (3) Require all clinical staff to report infection control issues to 
the dialysis facility's medical director (see Sec. 494.150 of this 
part) and the quality improvement committee.
    (c) Standard: Reporting. The facility must report incidences of 
communicable diseases as required by Federal, State, and local 
regulations.



Sec. 494.40  Condition: Water and dialysate quality.

    The facility must be able to demonstrate the following:
    (a) Standard: Water purity. Water and equipment used for dialysis 
meets the water and dialysate quality standards

[[Page 758]]

and equipment requirements found in the Association for the Advancement 
of Medical Instrumentation (AAMI) publication, ``Dialysate for 
hemodialysis,'' ANSI/AAMI RD52: 2004. The Director of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. This publication is available for 
inspection at the CMS Information Resource Center, 7500 Security 
Boulevard, Central Building, 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. Copies may be purchased from the Association for the 
Advancement of Medical Instrumentation, 3300 Washington Boulevard, Suite 
400, Arlington, VA 22201-4598.
    (b) Standard: Chlorine/chloramines. (1) The water treatment system 
must include a component or carbon tank which removes chlorine/
chloramine along with a backup component or second carbon tank in series 
for chlorine/chloramine removal;
    (2)(i) If the test results from the port of the initial component or 
carbon tank referred to in section 6.2.5 of AAMI RD52:2004 are greater 
than 0.5 mg/L for free chlorine or 0.1 mg/L for chloramines, or equal to 
or greater than 0.1 mg/L of total chlorine, then the second component or 
carbon tank which removes chlorine/chloramine must be tested;
    (ii) If the test results from the last component or carbon tank are 
greater than the parameters for chlorine or chloramine specified in 
paragraph (b)(2)(i) of this section the facility must--
    (A) Immediately take corrective action to bring chlorine or 
chloramine levels into compliance with paragraph (b)(2)(i) of this 
section and confirm through testing that the corrective action has been 
effective, or terminate dialysis treatment to protect patients from 
exposure to chlorine/chloramine;
    (B) Only allow use of purified water in a holding tank, if 
appropriate, and if testing shows water chlorine or chloramine levels 
that are in compliance with paragraph (b)(2)(i) of this section; and
    (C) Immediately notify the medical director; and
    (D) Take corrective action to ensure ongoing compliance with 
acceptable chlorine and chloramine levels as described in paragraph 
(b)(2)(i) of this section.
    (c) Standard: Corrective action plan. Water testing results 
including, but not limited to, chemical, microbial, and endotoxin levels 
which meet AAMI action levels or deviate from the AAMI standards must be 
addressed with a corrective action plan that ensures patient safety.
    (d) Standard: Adverse events. A dialysis facility must maintain 
active surveillance of patient reactions during and following dialysis. 
When clinically indicated (for example, after adverse patient reactions) 
the facility must--
    (1) Obtain blood and dialysate cultures and endotoxin levels;
    (2) Evaluate the water purification system; and
    (3) Take corrective action.
    (e) Standard: In-center use of preconfigured hemodialysis systems. 
When using a preconfigured, FDA-approved hemodialysis system designed, 
tested and validated to yield AAMI quality (which includes standards for 
chemical and chlorine/chloramine testing) water and dialysate, the 
system's FDA-approved labeling must be adhered to for machine use and 
monitoring of the water and dialysate quality. The facility must meet 
all AAMI RD52:2004 requirements for water and dialysate. Moreover, the 
facility must perform bacteriological and endotoxin testing on a 
quarterly, or more frequent basis, as needed, to ensure that the water 
and dialysate are within AAMI limits.



Sec. 494.50  Condition: Reuse of hemodialyzers and bloodlines.

    (a) Standard: General requirements for the reuse of hemodialyzers 
and bloodlines. Certain hemodialyzers and bloodlines--
    (1) May be reused for certain patients with the exception of 
Hepatitis B positive patients;
    (2) Must be reused only for the same patient; and

[[Page 759]]

    (3) Must be labeled for multiple reuse in accordance with the 
premarket notification provisions of section 510(k) of the Food, Drug, 
and Cosmetics Act and 21 CFR 876.5860.
    (b) Standard: Reprocessing requirements for the reuse of 
hemodialyzers and bloodlines. A dialysis facility that reuses 
hemodialyzers and bloodlines must adhere to the following reprocessing 
guidelines:
    (1) Meet the requirements of AAMI published in ``Reuse of 
Hemodialyzers,'' third edition, ANSI/AAMI RD47:2002 and RD47:2002/
A1:2003. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. This publication is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Central Building, 
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. Copies may be purchased 
from the Association for the Advancement of Medical Instrumentation, 
3300 Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
    (2) Reprocess hemodialyzers and bloodlines--
    (i) By following the manufacturer's recommendations; or
    (ii) Using an alternate method and maintaining documented evidence 
that the method is safe and effective.
    (3) Not expose hemodialyzers to more than one chemical germicide, 
other than bleach (used as a cleaner in this application), during the 
life of the dialyzer. All hemodialyzers must be discarded before a 
different chemical germicide is used in the facility.
    (c) Standard: Monitoring, evaluation, and reporting requirements for 
the reuse of hemodialyzers and bloodlines. In addition to the 
requirements for hemodialyzer and bloodline reuse specified in 
paragraphs (a) and (b) of this section, the dialysis facility must 
adhere to the following:
    (1) Monitor patient reactions during and following dialysis.
    (2) When clinically indicated (for example, after adverse patient 
reactions), the facility must--
    (i) Obtain blood and dialysate cultures and endotoxin levels; and
    (ii) Undertake evaluation of its dialyzer reprocessing and water 
purification system. When this evaluation suggests a cluster of adverse 
patient reactions is associated with hemodialyzer reuse, the facility 
must suspend reuse of hemodialyzers until it is satisfied the problem 
has been corrected.
    (iii) Report the adverse outcomes to the FDA and other Federal, 
State or local government agencies as required by law.



Sec. 494.60  Condition: Physical environment.

    The dialysis facility must be designed, constructed, equipped, and 
maintained to provide dialysis patients, staff, and the public a safe, 
functional, and comfortable treatment environment.
    (a) Standard: Building. The building in which dialysis services are 
furnished must be constructed and maintained to ensure the safety of the 
patients, the staff, and the public.
    (b) Standard: Equipment maintenance. The dialysis facility must 
implement and maintain a program to ensure that all equipment (including 
emergency equipment, dialysis machines and equipment, and the water 
treatment system) are maintained and operated in accordance with the 
manufacturer's recommendations.
    (c) Standard: Patient care environment. (1) The space for treating 
each patient must be sufficient to provide needed care and services, 
prevent cross-contamination, and to accommodate medical emergency 
equipment and staff.
    (2) The dialysis facility must:
    (i) Maintain a comfortable temperature within the facility; and
    (ii) Make reasonable accommodations for the patients who are not 
comfortable at this temperature.
    (3) The dialysis facility must make accommodations to provide for 
patient privacy when patients are examined or treated and body exposure 
is required.

[[Page 760]]

    (4) Patients must be in view of staff during hemodialysis treatment 
to ensure patient safety (video surveillance will not meet this 
requirement).
    (d) Standard: Fire safety. (1) Except as provided in paragraph 
(d)(2) of this section, dialysis facilities that do not provide one or 
more exits to the outside at grade level from the patient treatment area 
level must comply with provisions of the Life Safety Code (NFPA 101 and 
its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 
12-4) applicable to Ambulatory Health Care Occupancies, regardless of 
the number of patients served.
    (2) Notwithstanding paragraph (d)(1) of this section, dialysis 
facilities participating in Medicare as of October 14, 2008 that require 
sprinkler systems are those housed in multi-story buildings construction 
Types II(000), III(200), or V(000), as defined in the Life Safety Code, 
section 21.1.6.1, which were constructed after January 1, 2008, and 
those housed in high rise buildings over 75 feet in height, which were 
constructed after January 1, 2008.
    (3) If CMS finds that a fire and safety code imposed by the 
facility's State law adequately protects a dialysis facility's patients, 
CMS may allow the State survey agency to apply the State's fire and 
safety code instead of the Life Safety Code.
    (4) In consideration of a recommendation by the State survey agency 
or at the discretion of the Secretary, the Secretary may waive, for 
periods deemed appropriate, specific provisions of the Life Safety Code, 
which would result in unreasonable hardship upon an ESRD facility, but 
only if the waiver will not adversely affect the health and safety of 
the patients.
    (5) No dialysis facility may operate in a building that is adjacent 
to an industrial high hazard area, as described in sections 20.1.3.7 and 
21.1.3.7 of the Health Care Facilities Code (NFPA 99 and its Tentative 
Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5, and TIA 12-
6).
    (e) Standard: Building safety. (1) Dialysis facilities that do not 
provide one or more exits to the outside at grade level from the patient 
treatment area level must meet the applicable provisions of the Health 
Care Facilities Code, regardless of the number of patients served.
    (2) Chapters 7, 8, 12, and 13 of the Health Care Facilities Code do 
not apply to a dialysis facility.
    (3) If application of the Health Care Facilities Code would result 
in unreasonable hardship for the dialysis facility, CMS may waive 
specific provisions of the Health Care Facilities Code for such 
facility, but only if the waiver does not adversely affect the health 
and safety of patients.
    (f) Incorporation by reference. The standards incorporated by 
reference in this section are approved for incorporation by reference by 
the Director of the Office of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the 
sources listed below. 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, email [email protected], 
or go to: www.archives.gov/federal_register/cfr/ibr-locations.html. If 
any changes in the editions of the Codes 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, Health Care Facilities Code, 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.

[[Page 761]]

    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[73 FR 20475, Apr. 15, 2008, as amended at 77 FR 29031, May 16, 2012; 81 
FR 64042, Sept. 16, 2016; 84 FR 51832, Sept. 30, 2019]



Sec. 494.62  Condition of participation: Emergency preparedness.

    The dialysis facility must comply with all applicable Federal, 
State, and local emergency preparedness requirements. These emergencies 
include, but are not limited to, fire, equipment or power failures, 
care-related emergencies, water supply interruption, and natural 
disasters likely to occur in the facility's geographic area. The 
dialysis facility 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 dialysis facility must develop and maintain 
an emergency preparedness plan that must be evaluated and updated at 
least every 2 years. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the dialysis facility 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. The dialysis facility must contact the local 
emergency preparedness agency at least annually to confirm that the 
agency is aware of the dialysis facility's needs in the event of an 
emergency.
    (b) Policies and procedures. The dialysis facility 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. These emergencies 
include, but are not limited to, fire, equipment or power failures, 
care-related emergencies, water supply interruption, and natural 
disasters likely to occur in the facility's geographic area. At a 
minimum, the policies and procedures must address the following:
    (1) A system to track the location of on-duty staff and sheltered 
patients in the dialysis facility's care during and after an emergency. 
If on-duty staff and sheltered patients are relocated during the 
emergency, the dialysis facility must document the specific name and 
location of the receiving facility or other location.
    (2) Safe evacuation from the dialysis facility, which includes staff 
responsibilities, and needs of the patients.
    (3) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (4) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (5) 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.
    (6) The development of arrangements with other dialysis facilities 
or other providers to receive patients in the event of limitations or 
cessation of operations to maintain the continuity of services to 
dialysis facility patients.
    (7) The role of the dialysis facility 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.
    (8) How emergency medical system assistance can be obtained when 
needed.

[[Page 762]]

    (9) A process by which the staff can confirm that emergency 
equipment, including, but not limited to, oxygen, airways, suction, 
defibrillator or automated external defibrillator, artificial 
resuscitator, and emergency drugs, are on the premises at all times and 
immediately available.
    (c) Communication plan. The dialysis facility 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) Patients' physicians.
    (iv) Other dialysis facilities.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional or local emergency preparedness 
staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) Dialysis facility's staff.
    (ii) Federal, State, tribal, regional, or local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
patients under the dialysis facility'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 patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the dialysis facility's 
needs, and its ability to provide assistance, to the authority having 
jurisdiction or the Incident Command Center, or designee.
    (d) Training, testing, and orientation. The dialysis facility must 
develop and maintain an emergency preparedness training, testing and 
patient orientation 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, testing, and patient orientation program must be evaluated 
and updated at least every 2 years.
    (1) Training program. The dialysis facility 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) Provide emergency preparedness training at least every 2 years.
    (iii) Demonstrate staff knowledge of emergency procedures, including 
informing patients of--
    (A) What to do;
    (B) Where to go, including instructions for occasions when the 
geographic area of the dialysis facility must be evacuated;
    (C) Whom to contact if an emergency occurs while the patient is not 
in the dialysis facility. This contact information must include an 
alternate emergency phone number for the facility for instances when the 
dialysis facility is unable to receive phone calls due to an emergency 
situation (unless the facility has the ability to forward calls to a 
working phone number under such emergency conditions); and
    (D) How to disconnect themselves from the dialysis machine if an 
emergency occurs.
    (iv) Demonstrate that, at a minimum, its patient care staff 
maintains current CPR certification; and
    (v) Properly train its nursing staff in the use of emergency 
equipment and emergency drugs.
    (vi) Maintain documentation of the training.
    (vii) If the emergency preparedness policies and procedures are 
significantly updated, the dialysis facility must conduct training on 
the updated policies and procedures.
    (2) Testing. The dialysis facility must conduct exercises to test 
the emergency plan at least annually. The dialysis facility must do all 
of the following:

[[Page 763]]

    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, an 
individual, and a facility-based functional exercise every 2 years; or
    (B) If the dialysis facility experiences an actual natural or man-
made emergency that requires activation of the emergency plan, the 
dialysis facility 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 dialysis facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the dialysis facility's emergency plan, as needed.
    (3) Patient orientation: Emergency preparedness patient training. 
The facility must provide appropriate orientation and training to 
patients, including the areas specified in paragraph (d)(1) of this 
section.
    (e) Integrated healthcare systems. If a dialysis facility 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 dialysis facility may choose to 
participate in the healthcare system's coordinated emergency 
preparedness program. If elected, the unified and integrated emergency 
preparedness program must do all of 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 
all of 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 64042, Sept. 16, 2016, as amended by 84 FR 51833, Sept. 30, 2019]



                         Subpart C_Patient Care



Sec. 494.70  Condition: Patients' rights.

    The dialysis facility must inform patients (or their 
representatives) of their rights (including their privacy rights) and 
responsibilities when they begin their treatment and must protect and 
provide for the exercise of those rights.
    (a) Standard: Patients' rights. The patient has the right to--
    (1) Respect, dignity, and recognition of his or her individuality 
and personal needs, and sensitivity to his or her psychological needs 
and ability to cope with ESRD;

[[Page 764]]

    (2) Receive all information in a way that he or she can understand;
    (3) Privacy and confidentiality in all aspects of treatment;
    (4) Privacy and confidentiality in personal medical records;
    (5) Be informed about and participate, if desired, in all aspects of 
his or her care, and be informed of the right to refuse treatment, to 
discontinue treatment, and to refuse to participate in experimental 
research;
    (6) Be informed about his or her right to execute advance 
directives, and the facility's policy regarding advance directives;
    (7) Be informed about all treatment modalities and settings, 
including but not limited to, transplantation, home dialysis modalities 
(home hemodialysis, intermittent peritoneal dialysis, continuous 
ambulatory peritoneal dialysis, continuous cycling peritoneal 
dialysis),and in-facility hemodialysis. The patient has the right to 
receive resource information for dialysis modalities not offered by the 
facility, including information about alternative scheduling options for 
working patients;
    (8) Be informed of facility policies regarding patient care, 
including, but not limited to, isolation of patients;
    (9) Be informed of facility policies regarding the reuse of dialysis 
supplies, including hemodialyzers;
    (10) Be informed by the physician, nurse practitioner, clinical 
nurse specialist, or physician's assistant treating the patient for ESRD 
of his or her own medical status as documented in the patient's medical 
record, unless the medical record contains a documented 
contraindication;
    (11) Be informed of services available in the facility and charges 
for services not covered under Medicare;
    (12) Receive the necessary services outlined in the patient plan of 
care described in Sec. 494.90;
    (13) Be informed of the rules and expectations of the facility 
regarding patient conduct and responsibilities;
    (14) Be informed of the facility's internal grievance process;
    (15) Be informed of external grievance mechanisms and processes, 
including how to contact the ESRD Network and the State survey agency;
    (16) Be informed of his or her right to file internal grievances or 
external grievances or both without reprisal or denial of services; and
    (17) Be informed that he or she may file internal or external 
grievances, personally, anonymously or through a representative of the 
patient's choosing.
    (b) Standard: Right to be informed regarding the facility's 
discharge and transfer policies. The patient has the right to--
    (1) Be informed of the facility's policies for transfer, routine or 
involuntary discharge, and discontinuation of services to patients; and
    (2) Receive written notice 30 days in advance of an involuntary 
discharge, after the facility follows the involuntary discharge 
procedures described in Sec. 494.180(f)(4). In the case of immediate 
threats to the health and safety of others, an abbreviated discharge 
procedure may be allowed.
    (c) Standard: Right to be informed of health coverage options. For 
patients of dialysis facilities that make payments of premiums for 
individual market health plans (in any amount), whether directly, 
through a parent organization (such as a dialysis corporation), or 
through another entity (including by providing contributions to entities 
that make such payments), the patient has the right to--
    (1) Be informed annually, on a timely basis for each plan year, of 
all available health coverage options, including but not limited to 
Medicare, Medicaid, CHIP and individual market plans. This must include 
information on:
    (i) How plans in the individual market will affect the patient's 
access to, and costs for the providers and suppliers, services, and 
prescription drugs that are currently within the individual's ESRD plan 
of care as well as those likely to result from other documented health 
care needs. This must include an overview of the health-related and 
financial risks and benefits of the individual market plans available to 
the patient (including plans offered through and outside the Exchange).

[[Page 765]]

    (ii) Medicare and Medicaid/Children's Health Insurance Coverage 
(CHIP) coverage, including Medicare Savings Programs, and how enrollment 
in those programs will affect the patient's access to and costs for 
health care providers, services, and prescription drugs that are 
currently within the individual's plan of care.
    (iii) Each option's coverage and anticipated costs associated with 
transplantation, including patient and living donor costs for pre- and 
post-transplant care.
    (2) Receive current information from the facility about premium 
assistance for enrollment in an individual market health plan that may 
be available to the patient from the facility, its parent organization, 
or third parties, including but not limited to limitations and any 
associated risks of such assistance.
    (3) Receive current information about the facility's, or its parent 
organization's, contributions to patients or third parties that 
subsidize the individual's enrollment in individual market health plans 
for individuals on dialysis, including the reimbursements for services 
rendered that the facility receives as a result of subsidizing such 
enrollment.
    (d) Standard: Posting of rights. The dialysis facility must 
prominently display a copy of the patient's rights in the facility, 
including the current State agency and ESRD network mailing addresses 
and telephone complaint numbers, where it can be easily seen and read by 
patients.

[73 FR 20475, Apr. 15, 2008, as amended at 81 FR 90227, Dec. 14, 2016]



Sec. 494.80  Condition: Patient assessment.

    The facility's interdisciplinary team consists of, at a minimum, the 
patient or the patient's designee (if the patient chooses), a registered 
nurse, a physician treating the patient for ESRD, a social worker, and a 
dietitian. The interdisciplinary team is responsible for providing each 
patient with an individualized and comprehensive assessment of his or 
her needs. The comprehensive assessment must be used to develop the 
patient's treatment plan and expectations for care.
    (a) Standard: Assessment criteria. The patient's comprehensive 
assessment must include, but is not limited to, the following:
    (1) Evaluation of current health status and medical condition, 
including co-morbid conditions.
    (2) Evaluation of the appropriateness of the dialysis prescription, 
blood pressure, and fluid management needs.
    (3) Laboratory profile, immunization history, and medication 
history.
    (4) Evaluation of factors associated with anemia, such as 
hematocrit, hemoglobin, iron stores, and potential treatment plans for 
anemia, including administration of erythropoiesis-stimulating agent(s).
    (5) Evaluation of factors associated with renal bone disease.
    (6) Evaluation of nutritional status by a dietitian.
    (7) Evaluation of psychosocial needs by a social worker.
    (8) Evaluation of dialysis access type and maintenance (for example, 
arteriovenous fistulas, arteriovenous grafts, and peritoneal catheters).
    (9) Evaluation of the patient's abilities, interests, preferences, 
and goals, including the desired level of participation in the dialysis 
care process; the preferred modality (hemodialysis or peritoneal 
dialysis), and setting, (for example, home dialysis), and the patient's 
expectations for care outcomes.
    (10) Evaluation of suitability for a transplantation referral, based 
on criteria developed by the prospective transplantation center and its 
surgeon(s). If the patient is not suitable for transplantation referral, 
the basis for nonreferral must be documented in the patient's medical 
record.
    (11) Evaluation of family and other support systems.
    (12) Evaluation of current patient physical activity level.
    (13) Evaluation for referral to vocational and physical 
rehabilitation services.
    (b) Standard: Frequency of assessment for patients admitted to the 
dialysis facility. (1) An initial comprehensive assessment must be 
conducted on all new patients (that is, all admissions to a dialysis 
facility), within the latter of 30 calendar days or 13 outpatient 
hemodialysis sessions beginning with the first outpatient dialysis 
session.

[[Page 766]]

    (2) A follow up comprehensive reassessment must occur within 3 
months after the completion of the initial assessment to provide 
information to adjust the patient's plan of care specified in Sec. 
494.90.
    (c) Standard: Assessment of treatment prescription. The adequacy of 
the patient's dialysis prescription, as described in Sec. 494.90(a)(1), 
must be assessed on an ongoing basis as follows:
    (1) Hemodialysis patients. At least monthly by calculating delivered 
Kt/V or an equivalent measure.
    (2) Peritoneal dialysis patients. At least every 4 months by 
calculating delivered weekly Kt/V or an equivalent measure.
    (d) Standard: Patient reassessment. In accordance with the standards 
specified in paragraphs (a)(1) through (a)(13) of this section, a 
comprehensive reassessment of each patient and a revision of the plan of 
care must be conducted--
    (1) At least annually for stable patients; and
    (2) At least monthly for unstable patients including, but not 
limited to, patients with the following:
    (i) Extended or frequent hospitalizations;
    (ii) Marked deterioration in health status;
    (iii) Significant change in psychosocial needs; or
    (iv) Concurrent poor nutritional status, unmanaged anemia, and 
inadequate dialysis.



Sec. 494.90  Condition: Patient plan of care.

    The interdisciplinary team as defined at Sec. 494.80 must develop 
and implement a written, individualized comprehensive plan of care that 
specifies the services necessary to address the patient's needs, as 
identified by the comprehensive assessment and changes in the patient's 
condition, and must include measurable and expected outcomes and 
estimated timetables to achieve these outcomes. The outcomes specified 
in the patient plan of care must be consistent with current evidence-
based professionally-accepted clinical practice standards.
    (a) Standard: Development of patient plan of care. The 
interdisciplinary team must develop a plan of care for each patient. The 
plan of care must address, but not be limited to, the following:
    (1) Dose of dialysis. The interdisciplinary team must provide the 
necessary care and services to manage the patient's volume status; and 
achieve and sustain the prescribed dose of dialysis to meet a 
hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V 
of at least 1.7 or meet an alternative equivalent professionally-
accepted clinical practice standard for adequacy of dialysis.
    (2) Nutritional status. The interdisciplinary team must provide the 
necessary care and counseling services to achieve and sustain an 
effective nutritional status. A patient's albumin level and body weight 
must be measured at least monthly. Additional evidence-based 
professionally-accepted clinical nutrition indicators may be monitored, 
as appropriate.
    (3) Mineral metabolism. Provide the necessary care to manage mineral 
metabolism and prevent or treat renal bone disease.
    (4) Anemia. The interdisciplinary team must provide the necessary 
care and services to achieve and sustain the clinically appropriate 
hemoglobin/hematocrit level. The patient's hemoglobin/hematocrit must be 
measured at least monthly. The dialysis facility must conduct an 
evaluation of the patient's anemia management needs. For a home dialysis 
patient, the facility must evaluate whether the patient can safely, 
aseptically, and effectively administer erythropoiesis-stimulating 
agents and store this medication under refrigeration if necessary. The 
patient's response to erythropoiesis-stimulating agent(s), including 
blood pressure levels and utilization of iron stores, must be monitored 
on a routine basis.
    (5) Vascular access. The interdisciplinary team must provide 
vascular access monitoring and appropriate, timely referrals to achieve 
and sustain vascular access. The hemodialysis patient must be evaluated 
for the appropriate vascular access type, taking into consideration co-
morbid conditions, other risk factors, and whether the patient is a 
potential candidate for arteriovenous

[[Page 767]]

fistula placement. The patient's vascular access must be monitored to 
prevent access failure, including monitoring of arteriovenous grafts and 
fistulae for symptoms of stenosis.
    (6) Psychosocial status. The interdisciplinary team must provide the 
necessary monitoring and social work interventions. These include 
counseling services and referrals for other social services, to assist 
the patient in achieving and sustaining an appropriate psychosocial 
status as measured by a standardized mental and physical assessment tool 
chosen by the social worker, at regular intervals, or more frequently on 
an as-needed basis.
    (7) Modality--(i) Home dialysis. The interdisciplinary team must 
identify a plan for the patient's home dialysis or explain why the 
patient is not a candidate for home dialysis.
    (ii) Transplantation status. When the patient is a transplant 
referral candidate, the interdisciplinary team must develop plans for 
pursuing transplantation. The patient's plan of care must include 
documentation of the--
    (A) Plan for transplantation, if the patient accepts the 
transplantation referral;
    (B) Patient's decision, if the patient is a transplantation referral 
candidate but declines the transplantation referral; or
    (C) Reason(s) for the patient's nonreferral as a transplantation 
candidate as documented in accordance with Sec. 494.80(a)(10).
    (8) Rehabilitation status. The interdisciplinary team must assist 
the patient in achieving and sustaining an appropriate level of 
productive activity, as desired by the patient, including the 
educational needs of pediatric patients (patients under the age of 18 
years), and make rehabilitation and vocational rehabilitation referrals 
as appropriate.
    (b) Standard: Implementation of the patient plan of care. (1) The 
patient's plan of care must--
    (i) Be completed by the interdisciplinary team, including the 
patient if the patient desires; and
    (ii) Be signed by team members, including the patient or the 
patient's designee; or, if the patient chooses not to sign the plan of 
care, this choice must be documented on the plan of care, along with the 
reason the signature was not provided.
    (2) Implementation of the initial plan of care must begin within the 
latter of 30 calendar days after admission to the dialysis facility or 
13 outpatient hemodialysis sessions beginning with the first outpatient 
dialysis session. Implementation of monthly or annual updates of the 
plan of care must be performed within 15 days of the completion of the 
additional patient assessments specified in Sec. 494.80(d).
    (3) If the expected outcome is not achieved, the interdisciplinary 
team must adjust the patient's plan of care to achieve the specified 
goals. When a patient is unable to achieve the desired outcomes, the 
team must--
    (i) Adjust the plan of care to reflect the patient's current 
condition;
    (ii) Document in the record the reasons why the patient was unable 
to achieve the goals; and
    (iii) Implement plan of care changes to address the issues 
identified in paragraph (b)(3)(ii) of this section.
    (4) The dialysis facility must ensure that all dialysis patients are 
seen by a physician, nurse practitioner, clinical nurse specialist, or 
physician's assistant providing ESRD care at least monthly, as evidenced 
by a monthly progress note placed in the medical record, and 
periodically while the hemodialysis patient is receiving in-facility 
dialysis.
    (c) Standard: Transplantation referral tracking. The 
interdisciplinary team must--
    (1) Track the results of each kidney transplant center referral;
    (2) Monitor the status of any facility patients who are on the 
transplant wait list; and
    (3) Communicate with the transplant center regarding patient 
transplant status at least annually, and when there is a change in 
transplant candidate status.
    (d) Standard: Patient education and training. The patient care plan 
must include, as applicable, education and training for patients and 
family members or caregivers or both, in aspects of the dialysis 
experience, dialysis management, infection prevention and personal care, 
home dialysis and self-care,

[[Page 768]]

quality of life, rehabilitation, transplantation, and the benefits and 
risks of various vascular access types.



Sec. 494.100  Condition: Care at home.

    A dialysis facility that is certified to provide services to home 
patients must ensure through its interdisciplinary team, that home 
dialysis services are at least equivalent to those provided to in-
facility patients and meet all applicable conditions of this part.
    (a) Standard: Training. The interdisciplinary team must oversee 
training of the home dialysis patient, the designated caregiver, or 
self-dialysis patient before the initiation of home dialysis or self-
dialysis (as defined in Sec. 494.10) and when the home dialysis 
caregiver or home dialysis modality changes. The training must--
    (1) Be provided by a dialysis facility that is approved to provide 
home dialysis services;
    (2) Be conducted by a registered nurse who meets the requirements of 
Sec. 494.140(b)(2); and
    (3) Be conducted for each home dialysis patient and address the 
specific needs of the patient, in the following areas:
    (i) The nature and management of ESRD.
    (ii) The full range of techniques associated with the treatment 
modality selected, including effective use of dialysis supplies and 
equipment in achieving and delivering the physician's prescription of 
Kt/V or URR, and effective administration of erythropoiesis-stimulating 
agent(s) (if prescribed) to achieve and maintain a target level 
hemoglobin or hematocrit as written in patient's plan of care.
    (iii) How to detect, report, and manage potential dialysis 
complications, including water treatment problems.
    (iv) Availability of support resources and how to access and use 
resources.
    (v) How to self-monitor health status and record and report health 
status information.
    (vi) How to handle medical and non-medical emergencies.
    (vii) Infection control precautions.
    (viii) Proper waste storage and disposal procedures.
    (b) Standard: Home dialysis monitoring. The dialysis facility must--
    (1) Document in the medical record that the patient, the caregiver, 
or both received and demonstrated adequate comprehension of the 
training;
    (2) Retrieve and review complete self-monitoring data and other 
information from self-care patients or their designated caregiver(s) at 
least every 2 months; and
    (3) Maintain this information in the patient's medical record.
    (c) Standard: Support services. (1) A home dialysis facility must 
furnish (either directly, under agreement, or by arrangement with 
another ESRD facility) home dialysis support services regardless of 
whether dialysis supplies are provided by the dialysis facility or a 
durable medical equipment company. Services include, but are not limited 
to, the following:
    (i) Periodic monitoring of the patient's home adaptation, including 
visits to the patient's home by facility personnel in accordance with 
the patient's plan of care.
    (ii) Coordination of the home patient's care by a member of the 
dialysis facility's interdisciplinary team.
    (iii) Development and periodic review of the patient's 
individualized comprehensive plan of care that specifies the services 
necessary to address the patient's needs and meets the measurable and 
expected outcomes as specified in Sec. 494.90 of this part.
    (iv) Patient consultation with members of the interdisciplinary 
team, as needed.
    (v) Monitoring of the quality of water and dialysate used by home 
hemodialysis patients including conducting an onsite evaluation and 
testing of the water and dialysate system in accordance with--
    (A) The recommendations specified in the manufacturers' 
instructions; and
    (B) The system's FDA-approved labeling for preconfigured systems 
designed, tested, and validated to meet AAMI quality (which includes 
standards for chemical and chlorine/chloramine testing) water and 
dialysate. The facility must meet testing and other requirements of AAMI 
RD52:2004. In addition, bacteriological and endotoxin testing must be 
performed on a quarterly, or more frequent basis

[[Page 769]]

as needed, to ensure that the water and dialysate are within the AAMI 
limits.
    (C) The dialysis facility must correct any water and dialysate 
quality problem for the home hemodialysis patient, and if necessary, 
arrange for backup dialysis until the problem is corrected if--
    (1) Analysis of the water and dialysate quality indicates 
contamination; or
    (2) The home hemodialysis patient demonstrates clinical symptoms 
associated with water and dialysate contamination.
    (vi) Purchasing, leasing, renting, delivering, installing, repairing 
and maintaining medically necessary home dialysis supplies and equipment 
(including supportive equipment) prescribed by the attending physician.
    (vii) Identifying a plan and arranging for emergency back-up 
dialysis services when needed.
    (2) The dialysis facility must maintain a recordkeeping system that 
ensures continuity of care and patient privacy. This includes items and 
services furnished by durable medical equipment (DME) suppliers referred 
to in Sec. 414.330(a)(2) of this chapter.



Sec. 494.110  Condition: Quality assessment and performance 
improvement.

    The dialysis facility must develop, implement, maintain, and 
evaluate an effective, data-driven, quality assessment and performance 
improvement program with participation by the professional members of 
the interdisciplinary team. The program must reflect the complexity of 
the dialysis facility's organization and services (including those 
services provided under arrangement), and must focus on indicators 
related to improved health outcomes and the prevention and reduction of 
medical errors. The dialysis facility must maintain and demonstrate 
evidence of its quality improvement and performance improvement program 
for review by CMS.
    (a) Standard: Program scope. (1) The program must include, but not 
be limited to, an ongoing program that achieves measurable improvement 
in health outcomes and reduction of medical errors by using indicators 
or performance measures associated with improved health outcomes and 
with the identification and reduction of medical errors.
    (2) The dialysis facility must measure, analyze, and track quality 
indicators or other aspects of performance that the facility adopts or 
develops that reflect processes of care and facility operations. These 
performance components must influence or relate to the desired outcomes 
or be the outcomes themselves. The program must include, but not be 
limited to, the following:
    (i) Adequacy of dialysis.
    (ii) Nutritional status.
    (iii) Mineral metabolism and renal bone disease.
    (iv) Anemia management.
    (v) Vascular access.
    (vi) Medical injuries and medical errors identification.
    (vii) Hemodialyzer reuse program, if the facility reuses 
hemodialyzers.
    (viii) Patient satisfaction and grievances.
    (ix) Infection control; with respect to this component the facility 
must--
    (A) Analyze and document the incidence of infection to identify 
trends and establish baseline information on infection incidence;
    (B) Develop recommendations and action plans to minimize infection 
transmission, promote immunization; and
    (C) Take actions to reduce future incidents.
    (b) Standard: Monitoring performance improvement. The dialysis 
facility must continuously monitor its performance, take actions that 
result in performance improvements, and track performance to ensure that 
improvements are sustained over time.
    (c) Standard: Prioritizing improvement activities. The dialysis 
facility must set priorities for performance improvement, considering 
prevalence and severity of identified problems and giving priority to 
improvement activities that affect clinical outcomes or patient safety. 
The facility must immediately correct any identified problems that 
threaten the health and safety of patients.

[[Page 770]]



Sec. 494.120  Condition: Special purpose renal dialysis facilities.

    A special purpose renal dialysis facility is approved to furnish 
dialysis on a short-term basis at special locations. Special purpose 
dialysis facilities are divided into two categories: vacation camps 
(locations that serve ESRD patients while the patients are in a 
temporary residence) and facilities established to serve ESRD patients 
under emergency circumstances.
    (a) Standard: Approval period. The period of approval for a special 
purpose renal dialysis facility may not exceed 8 months in any 12-month 
period.
    (b) Standard: Service limitation. Special purpose renal dialysis 
facilities are limited to areas in which there are limited dialysis 
resources or access-to-care problems due to an emergency circumstance. A 
special purpose renal dialysis facility may provide services only to 
those patients who would otherwise be unable to obtain treatments in the 
geographic locality served by the facility.
    (c) Standard: Scope of requirements--(1) Scope of requirements for a 
vacation camp. A vacation camp that provides dialysis services must be 
operated under the direction of a certified renal dialysis facility that 
assumes full responsibility for the care provided to patients. A special 
purpose renal dialysis facility established as a vacation camp must 
comply with the following conditions for coverage--
    (i) Infection control at Sec. 494.30;
    (ii) Water and dialysate quality at Sec. 494.40 (except as provided 
in paragraph (c)(1)(viii) of this section);
    (iii) Reuse of hemodialyzers at Sec. 494.50 (if reuse is 
performed);
    (iv) Patients' rights and posting of patients' rights at Sec. 
494.70(a) and Sec. 494.70(c);
    (v) Laboratory services at Sec. 494.130;
    (vi) Medical director responsibilities for staff education and 
patient care policies and procedures at Sec. 494.150(c) and Sec. 
494.150(d);
    (vii) Medical records at Sec. 494.170; and
    (viii) When portable home water treatment systems are used in place 
of a central water treatment system, the facility may adhere to Sec. 
494.100(c)(1)(v) (home monitoring of water quality), in place of Sec. 
494.40 (water quality).
    (2) Scope of requirements for an emergency circumstance facility. A 
special purpose renal dialysis facility set up due to emergency 
circumstances may provide services only to those patients who would 
otherwise be unable to obtain treatments in the geographic areas served 
by the facility. These types of special purpose dialysis facilities must 
comply with paragraph (c)(1) of this section and addition to complying 
with the following conditions:
    (i) Section 494.20 (compliance with Federal, State, and local laws 
and regulations).
    (ii) Section 494.60 (physical environment).
    (iii) Section 494.70(a) through section 494.70(c) (patient rights).
    (iv) Section 494.140 (personnel qualifications).
    (v) Section 494.150 (medical director).
    (vi) Section 494.180 (governance).
    (d) Standard: Physician contact. The facility must contact the 
patient's physician, if possible, prior to initiating dialysis in the 
special purpose renal dialysis facility, to discuss the patient's 
current condition to assure care provided in the special purpose renal 
dialysis facility is consistent with the patient plan of care (described 
in Sec. 494.90).
    (e) Standard: Documentation. All patient care provided in the 
special purpose facility is documented and forwarded to the patient's 
usual dialysis facility, if possible, within 30 days of the last 
scheduled treatment in the special purpose renal dialysis facility.



Sec. 494.130  Condition: Laboratory services.

    The dialysis facility must provide, or make available, laboratory 
services (other than tissue pathology and histocompatibility) to meet 
the needs of the ESRD patient. Any laboratory services, including tissue 
pathology and histocompatibility must be furnished by or obtained from, 
a facility that meets the requirements for laboratory services specified 
in part 493 of this chapter.

[[Page 771]]



                        Subpart D_Administration



Sec. 494.140  Condition: Personnel qualifications.

    All dialysis facility staff must meet the applicable scope of 
practice board and licensure requirements in effect in the State in 
which they are employed. The dialysis facility's staff (employee or 
contractor) must meet the personnel qualifications and demonstrated 
competencies necessary to serve collectively the comprehensive needs of 
the patients. The dialysis facility's staff must have the ability to 
demonstrate and sustain the skills needed to perform the specific duties 
of their positions.
    (a) Standard: Medical director. (1) The medical director must be a 
board-certified physician in internal medicine or pediatrics by a 
professional board who has completed a board-approved training program 
in nephrology and has at least 12-months of experience providing care to 
patients receiving dialysis.
    (2) If a physician, as specified in paragraph (a)(1) of this 
section, is not available to direct a certified dialysis facility 
another physician may direct the facility, subject to the approval of 
the Secretary.
    (b) Standard: Nursing services--(1) Nurse manager. The facility must 
have a nurse manager responsible for nursing services in the facility 
who must--
    (i) Be a full time employee of the facility;
    (ii) Be a registered nurse; and
    (iii) Have at least 12 months of experience in clinical nursing, and 
an additional 6 months of experience in providing nursing care to 
patients on maintenance dialysis.
    (2) Self-care and home dialysis training nurse. The nurse 
responsible for self-care and/or home care training must--
    (i) Be a registered nurse; and
    (ii) Have at least 12 months experience in providing nursing care 
and an additional 3 months of experience in the specific modality for 
which the nurse will provide self-care training.
    (3) Charge nurse. The charge nurse responsible for each shift must--
    (i) Be a registered nurse, a licensed practical nurse, or vocational 
nurse who meets the practice requirements in the State in which he or 
she is employed;
    (ii) Have at least 12 months experience in providing nursing care, 
including 3 months of experience in providing nursing care to patients 
on maintenance dialysis; and
    (iii) If such nurse is a licensed practical nurse or licensed 
vocational nurse, work under the supervision of a registered nurse in 
accordance with state nursing practice act provisions.
    (4) Staff nurse. Each nurse who provides care and treatment to 
patients must be either a registered nurse or a practical nurse who 
meets the practice requirements in the State in which he or she is 
employed.
    (c) Standard: Dietitian. The facility must have a dietitian who 
must--
    (1) Be a registered dietitian with the Commission on Dietetic 
Registration; and
    (2) Have a minimum of 1 year professional work experience in 
clinical nutrition as a registered dietitian.
    (d) Standard: Social worker. The facility must have a social worker 
who--
    (1) Holds a master's degree in social work with a specialization in 
clinical practice from a school of social work accredited by the Council 
on Social Work Education; or
    (2) Has served at least 2 years as a social worker, 1 year of which 
was in a dialysis unit or transplantation program prior to September 1, 
1976, and has established a consultative relationship with a social 
worker who qualifies under Sec. 494.140(d)(1).
    (e) Standard: Patient care dialysis technicians. Patient care 
dialysis technicians must--
    (1) Meet all applicable State requirements for education, training, 
credentialing, competency, standards of practice, certification, and 
licensure in the State in which he or she is employed as a dialysis 
technician; and
    (2) Have a high school diploma or equivalency;
    (3) Have completed a training program that is approved by the 
medical director and governing body, under the direction of a registered 
nurse, focused on the operation of kidney dialysis equipment and 
machines, providing direct patient care, and communication

[[Page 772]]

and interpersonal skills, including patient sensitivity training and 
care of difficult patients. The training program must include the 
following subjects:
    (i) Principles of dialysis.
    (ii) Care of patients with kidney failure, including interpersonal 
skills.
    (iii) Dialysis procedures and documentation, including initiation, 
proper cannulation techniques, monitoring, and termination of dialysis.
    (iv) Possible complications of dialysis.
    (v) Water treatment and dialysate preparation.
    (vi) Infection control.
    (vii) Safety.
    (viii) Dialyzer reprocessing, if applicable.
    (4) Be certified under a State certification program or a national 
commercially available certification program, as follows--
    (i) For newly employed patient care technicians, within 18 months of 
being hired as a dialysis patient care technician; or
    (ii) For patient care technicians employed on October 14, 2008, 
within 18 months after such date.
    (f) Standard: Water treatment system technicians. Technicians who 
perform monitoring and testing of the water treatment system must 
complete a training program that has been approved by the medical 
director and the governing body.



Sec. 494.150  Condition: Responsibilities of the medical director.

    The dialysis facility must have a medical director who meets the 
qualifications of Sec. 494.140(a) to be responsible for the delivery of 
patient care and outcomes in the facility. The medical director is 
accountable to the governing body for the quality of medical care 
provided to patients. Medical director responsibilities include, but are 
not limited to, the following:
    (a) Quality assessment and performance improvement program.
    (b) Staff education, training, and performance.
    (c) Policies and procedures. The medical director must--
    (1) Participate in the development, periodic review and approval of 
a ``patient care policies and procedures manual'' for the facility; and
    (2) Ensure that--
    (i) All policies and procedures relative to patient admissions, 
patient care, infection control, and safety are adhered to by all 
individuals who treat patients in the facility, including attending 
physicians and nonphysician providers; and
    (ii) The interdisciplinary team adheres to the discharge and 
transfer policies and procedures specified in Sec. 494.180(f).



Sec. 494.160  [Reserved]



Sec. 494.170  Condition: Medical records.

    The dialysis facility must maintain complete, accurate, and 
accessible records on all patients, including home patients who elect to 
receive dialysis supplies and equipment from a supplier that is not a 
provider of ESRD services and all other home dialysis patients whose 
care is under the supervision of the facility.
    (a) Standard: Protection of the patient's record. The dialysis 
facility must--
    (1) Safeguard patient records against loss, destruction, or 
unauthorized use; and
    (2) Keep confidential all information contained in the patient's 
record, except when release is authorized pursuant to one of the 
following:
    (i) The transfer of the patient to another facility.
    (ii) Certain exceptions provided for in the law.
    (iii) Provisions allowed under third party payment contracts.
    (iv) Approval by the patient.
    (v) Inspection by authorized agents of the Secretary, as required 
for the administration of the dialysis program.
    (3) Obtaining written authorization from the patient or legal 
representative before releasing information that is not authorized by 
law.
    (b) Standard: Completion of patient records and centralization of 
clinical information. (1) Current medical records and those of 
discharged patients must be completed promptly.
    (2) All clinical information pertaining to a patient must be 
centralized in the patient's record, including whether the patient has 
executed an

[[Page 773]]

advance directive. These records must be maintained in a manner such 
that each member of the interdisciplinary team has access to current 
information regarding the patient's condition and prescribed treatment.
    (3) The dialysis facility must complete, maintain, and monitor home 
care patients' records, including the records of patients who receive 
supplies and equipment from a durable medical equipment supplier.
    (c) Standard: Record retention and preservation. In accordance with 
45 CFR Sec. 164.530(j)(2), all patient records must be retained for 6 
years from the date of the patient's discharge, transfer, or death.
    (d) Standard: Transfer of patient record information. When a 
dialysis patient is transferred, the dialysis facility releasing the 
patient must send all requested medical record information to the 
receiving facility within 1 working day of the transfer.



Sec. 494.180  Condition: Governance.

    The ESRD facility is under the control of an identifiable governing 
body, or designated person(s) with full legal authority and 
responsibility for the governance and operation of the facility. The 
governing body adopts and enforces rules and regulations relative to its 
own governance and to the health care and safety of patients, to the 
protection of the patients' personal and property rights, and to the 
general operation of the facility.
    (a) Standard: Designating a chief executive officer or 
administrator. The governing body or designated person responsible must 
appoint an individual who serves as the dialysis facility's chief 
executive officer or administrator who exercises responsibility for the 
management of the facility and the provision of all dialysis services, 
including, but not limited to--
    (1) Staff appointments;
    (2) Fiscal operations;
    (3) The relationship with the ESRD networks; and
    (4) Allocation of necessary staff and other resources for the 
facility's quality assessment and performance improvement program as 
described in Sec. 494.110.
    (b) Standard: Adequate number of qualified and trained staff. The 
governing body or designated person responsible must ensure that--
    (1) An adequate number of qualified personnel are present whenever 
patients are undergoing dialysis so that the patient/staff ratio is 
appropriate to the level of dialysis care given and meets the needs of 
patients; and the registered nurse, social worker and dietitian members 
of the interdisciplinary team are available to meet patient clinical 
needs;
    (2) A registered nurse, who is responsible for the nursing care 
provided, is present in the facility at all times that in-center 
dialysis patients are being treated;
    (3) All staff, including the medical director, have appropriate 
orientation to the facility and their work responsibilities; and
    (4) All employees have an opportunity for continuing education and 
related development activities.
    (c) Standard: Medical staff appointments. The governing body--
    (1) Is responsible for all medical staff appointments and 
credentialing in accordance with State law, including attending 
physicians, physician assistants, nurse practitioners, and clinical 
nurse specialists; and
    (2) Ensures that all medical staff who provide care in the facility 
are informed of all facility policies and procedures, including the 
facility's quality assessment and performance improvement program 
specified in Sec. 494.110.
    (3) Communicates expectations to the medical staff regarding staff 
participation in improving the quality of medical care provided to 
facility patients.
    (d) Standard: Furnishing services. The governing body is responsible 
for ensuring that the dialysis facility furnishes services directly on 
its main premises or on other premises that are contiguous with the main 
premises and are under the direction of the same professional staff and 
governing body as the main premises (except for services provided under 
Sec. 494.100).
    (e) Standard: Internal grievance process. The facility's internal 
grievance process must be implemented so that the patient may file an 
oral or written

[[Page 774]]

grievance with the facility without reprisal or denial of services. The 
grievance process must include:
    (1) A clearly explained procedure for the submission of grievances.
    (2) Timeframes for reviewing the grievance.
    (3) A description of how the patient or the patient's designated 
representative will be informed of steps taken to resolve the grievance.
    (f) Standard: Involuntary discharge and transfer policies and 
procedures. The governing body must ensure that all staff follow the 
facility's patient discharge and transfer policies and procedures. The 
medical director ensures that no patient is discharged or transferred 
from the facility unless--
    (1) The patient or payer no longer reimburses the facility for the 
ordered services;
    (2) The facility ceases to operate;
    (3) The transfer is necessary for the patient's welfare because the 
facility can no longer meet the patient's documented medical needs; or
    (4) The facility has reassessed the patient and determined that the 
patient's behavior is disruptive and abusive to the extent that the 
delivery of care to the patient or the ability of the facility to 
operate effectively is seriously impaired, in which case the medical 
director ensures that the patient's interdisciplinary team--
    (i) Documents the reassessments, ongoing problem(s), and efforts 
made to resolve the problem(s), and enters this documentation into the 
patient's medical record;
    (ii) Provides the patient and the local ESRD Network with a 30-day 
notice of the planned discharge;
    (iii) Obtains a written physician's order that must be signed by 
both the medical director and the patient's attending physician 
concurring with the patient's discharge or transfer from the facility;
    (iv) Contacts another facility, attempts to place the patient there, 
and documents that effort; and
    (v) Notifies the State survey agency of the involuntary transfer or 
discharge.
    (5) In the case of immediate severe threats to the health and safety 
of others, the facility may utilize an abbreviated involuntary discharge 
procedure.
    (g) Standard: Emergency coverage. (1) The governing body is 
responsible for ensuring that the dialysis facility provides patients 
and staff with written instructions for obtaining emergency medical 
care.
    (2) The dialysis facility must have available at the nursing/
monitoring station, a roster with the names of physicians to be called 
for emergencies, when they can be called, and how they can be reached.
    (3) The dialysis facility must have an agreement with a hospital 
that can provide inpatient care, routine and emergency dialysis and 
other hospital services, and emergency medical care which is available 
24 hours a day, 7 days a week. The agreement must:
    (i) Ensure that hospital services are available promptly to the 
dialysis facility's patients when needed.
    (ii) Include reasonable assurances that patients from the dialysis 
facility are accepted and treated in emergencies.
    (h) Standard: Furnishing data and information for ESRD program 
administration. Effective February 1, 2009, the dialysis facility must 
furnish data and information to CMS and at intervals as specified by the 
Secretary. This information is used in a national ESRD information 
system and in compilations relevant to program administration, including 
claims processing and reimbursement, quality improvement, and 
performance assessment. The data and information must--
    (1) Be submitted at the intervals specified by the Secretary;
    (2) Be submitted electronically in the format specified by the 
Secretary;
    (3) Include, but not be limited to--
    (i) Cost reports;
    (ii) ESRD administrative forms;
    (iii) Patient survival information; and
    (iv) Existing ESRD clinical performance measures, and any future 
clinical performance standards developed in accordance with a voluntary 
consensus standards process identified by the Secretary.
    (i) Standard: Relationship with the ESRD network. The governing body 
receives and acts upon recommendations

[[Page 775]]

from the ESRD network. The dialysis facility must cooperate with the 
ESRD network designated for its geographic area, in fulfilling the terms 
of the Network's current statement of work. Each facility must 
participate in ESRD network activities and pursue network goals.
    (j) Standard: Disclosure of ownership. In accordance with Sec. 
420.200 through Sec. 420.206 of this chapter, the governing body must 
report ownership interests of 5 percent or more to its State survey 
agency.
    (k) Standard: Disclosure to Insurers of Payments of Premiums. (1) 
Facilities that make payments of premiums for individual market health 
plans (in any amount), whether directly, through a parent organization 
(such as a dialysis corporation), or through another entity (including 
by providing contributions to entities that make such payments) must--
    (i) Disclose to the applicable issuer each policy for which a third 
party payment described in this paragraph (k) will be made, and
    (ii) Obtain assurance from the issuer that the issuer will accept 
such payments for the duration of the plan year. If such assurances are 
not provided, the facility shall not make payments of premiums and shall 
take reasonable steps to ensure such payments are not made by the 
facility or by third parties to which the facility contributes as 
described in this paragraph (k).
    (2) If a facility is aware that a patient is not eligible for 
Medicaid and is not eligible to enroll in Medicare Part A and/or Part B 
except during the General Enrollment Period, and the facility is aware 
that the patient intends to enroll in Medicare Part A and/or Part B 
during that period, the standards under this paragraph (k) will not 
apply with respect to payments for that patient until July 1, 2017.

[73 FR 20475, Apr. 15, 2008, as amended at 81 FR 90228, Dec. 14, 2016]



PART 495_STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM--Table of Contents



                      Subpart A_General Provisions

Sec.
495.2 Basis and purpose.
495.4 Definitions.
495.5 Requirements for EPs seeking to reverse a hospital-based 
          determination under Sec. 495.4.
495.20 Meaningful use objectives and measures for EPs, eligible 
          hospitals, and CAHs before 2015.
495.22 Meaningful use objectives and measures for EPs, eligible 
          hospitals, and CAHs for 2015 through 2018.
495.24 Stage 3 meaningful use objectives and measures for EPs, eligible 
          hospitals and CAHs for 2019 and subsequent years.
495.40 Demonstration of meaningful use criteria.
495.60 Participation requirements for EPs, eligible hospitals, and CAHs.

         Subpart B_Requirements Specific to the Medicare Program

495.100 Definitions.
495.102 Incentive payments to EPs.
495.104 Incentive payments to eligible hospitals.
495.106 Incentive payments to CAHs.
495.108 Posting of required information.
495.110 Preclusion on administrative and judicial review.

Subpart C_Requirements Specific to Medicare Advantage (MA) Organizations

495.200 Definitions.
495.202 Identification of qualifying MA organizations, MA-EPs, and MA-
          affiliated eligible hospitals.
495.204 Incentive payments to qualifying MA organizations for qualifying 
          MA-EPs and qualifying MA-affiliated eligible hospitals.
495.206 Timeframe for payment to qualifying MA organizations.
495.208 Avoiding duplicate payment.
495.210 Meaningful EHR user attestation.
495.211 Payment adjustments effective for 2015 and subsequent MA payment 
          years with respect to MA EPs and MA-affiliated eligible 
          hospitals.
495.212 Limitation on review.

         Subpart D_Requirements Specific to the Medicaid Program

495.300 Basis and purpose.
495.302 Definitions.

[[Page 776]]

495.304 Medicaid provider scope and eligibility.
495.306 Establishing patient volume.
495.308 Net average allowable costs as the basis for determining the 
          incentive payment.
495.310 Medicaid provider incentive payments.
495.312 Process for payments.
495.314 Activities required to receive an incentive payment.
495.316 State monitoring and reporting regarding activities required to 
          receive an incentive payment.
495.318 State responsibilities for receiving FFP.
495.320 FFP for payments to Medicaid providers.
495.322 FFP for reasonable administrative expenses.
495.324 Prior approval conditions.
495.326 Disallowance of FFP.
495.328 Request for reconsideration of adverse determination.
495.330 Termination of FFP for failure to provide access to information.
495.332 State Medicaid health information technology (HIT) plan 
          requirements.
495.334 Reserved.
495.336 Health information technology planning advance planning document 
          requirements (HIT PAPD).
495.338 Health information technology implementation advance planning 
          document requirements (HIT IAPD).
495.340 As-needed HIT PAPD update and as-needed HIT IAPD update 
          requirements.
495.342 Annual HIT IAPD requirements.
495.344 Approval of the State Medicaid HIT plan, the HIT PAPD and 
          update, the HIT IAPD and update, and the annual HIT IAPD.
495.346 Access to systems and records.
495.348 Procurement standards.
495.350 State Medicaid agency attestations.
495.352 Reporting requirements.
495.354 Rules for charging equipment.
495.356 Nondiscrimination requirements.
495.358 Cost allocation plans.
495.360 Software and ownership rights.
495.362 Retroactive approval of FFP with an effective date of February 
          18, 2009.
495.364 Review and assessment of administrative activities and expenses 
          of Medicaid provider health information technology adoption 
          and operation.
495.366 Financial oversight and monitoring of expenditures.
495.368 Combating fraud and abuse.
495.370 Appeals process for a Medicaid provider receiving electronic 
          health record incentive payments.

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

    Source: 75 FR 44565, July 28, 2010, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 495.2  Basis and purpose.

    This part implements the following:
    (a) Section 1848(o) of the Act by establishing payment incentives 
under Medicare Part B for eligible professionals who adopt and 
meaningfully use certified electronic health record (EHR) technology.
    (b) Section 1853(1) of the Act to provide incentive payments to 
Medicare Advantage organizations for certain affiliated professionals 
who meaningfully use certified EHR technology and meet certain other 
requirements.
    (c) Section 1886(n) of the Act by establishing incentives payments 
for the meaningful use of certified EHR technology by subsection (d) 
hospitals, as defined under section 1886(d)(1)(B) of the Act, 
participating in the Medicare FFS program.
    (d) Section 1814(l) of the Act to provide an incentive payment to 
critical access hospitals that meaningfully use certified EHR technology 
based on the hospitals' reasonable costs.
    (e) Section 1853(m) of the Act to provide incentive payments to MA 
organizations for certain affiliated hospitals that meaningfully use 
certified EHR technology.
    (f) Sections 1903(a)(3)(F) and 1903(t) of the Act to provide 100 
percent Federal financial participation (FFP) to States for incentive 
payments to certain eligible providers participating in the Medicaid 
program to purchase, implement, and operate (including support services 
and training for staff) certified EHR technology and 90 percent FFP for 
State administrative expenses related to such incentive payments.
    (g) Sections 1848(a)(7), 1853(l)(4), 1886(b)(3)(B)(ix)(I), and 
1853(m)(4) of the Act, providing for payment reductions for inpatient 
services furnished on or after October 1, 2014 to Medicare beneficiaries 
by hospitals that are not meaningful users of certified EHR technology, 
and for covered professional services furnished on or after January 1, 
2015 to Medicare beneficiaries by certain professionals who are not 
meaningful users of certified EHR technology.

[[Page 777]]



Sec. 495.4  Definitions.

    In this part, unless otherwise indicated--
    Ambulatory surgical center-based EP means an EP who furnishes 75 
percent or more of his or her covered professional services in sites of 
service identified by the codes used in the HIPAA standard transaction 
as an ASC setting in the calendar year that is 2 years before the 
payment adjustment year.
    API stands for application programming interface.
    Certified electronic health record technology (CEHRT) means the 
following:
    (1) For any Federal fiscal year or calendar year before 2018, EHR 
technology (which could include multiple technologies) certified under 
the ONC Health IT Certification Program that meets one of the following:
    (i) The 2014 Edition Base EHR definition (as defined at 45 CFR 
170.102) and has been certified to the certification criteria that are 
necessary to be a Meaningful EHR User (as defined in this section), 
including the applicable measure calculation certification criterion at 
45 CFR 170.314(g)(1) or (2) for all certification criteria that support 
a meaningful use objective with a percentage-based measure.
    (ii) Certification to--
    (A) The following certification criteria:
    (1) CPOE at--
    (i) 45 CFR 170.314(a)(1), (18), (19) or (20); or
    (ii) 45 CFR 170.315(a)(1), (2) or (3).
    (2)(i) Record demographics at 45 CFR 170.314(a)(3); or
    (ii) 45 CFR 170.315(a)(5).
    (3)(i) Problem list at 45 CFR 170.314(a)(5); or
    (ii) 45 CFR 170.315(a)(6).
    (4)(i) Medication list at 45 CFR 170.314(a)(6); or
    (ii) 45 CFR 170.315(a)(7).
    (5)(i) Medication allergy list 45 CFR 170.314(a)(7); or
    (ii) 45 CFR 170.315(a)(8).
    (6)(i) Clinical decision support at 45 CFR 170.314(a)(8); or
    (ii) 45 CFR 170.315(a)(9).
    (7) Health information exchange at transitions of care at one of the 
following:
    (i) 45 CFR 170.314(b)(1) and (2).
    (ii) 45 CFR 170.314(b)(1), (b)(2), and (h)(1).
    (iii) 45 CFR 170.314(b)(1), (b)(2), and (b)(8).
    (iv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and (h)(1).
    (v) 45 CFR 170.314(b)(8) and (h)(1).
    (vi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(h)(2).
    (vii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(h)(2).
    (viii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(h)(2).
    (ix) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 
170.315(h)(2).
    (x) 45 CFR 170.314(b)(8), (h)(1), and 170.315(h)(2).
    (xi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(b)(1).
    (xii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(b)(1).
    (xiii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(b)(1).
    (xiv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 
170.315(b)(1).
    (xv) 45 CFR 170.314(b)(8), (h)(1), and 170.315(b)(1).
    (xvi) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), 
and 170.315(h)(1).
    (xvii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), 
and 170.315(h)(2).
    (xviii) 45 CFR 170.314(h)(1) and 170.315(b)(1).
    (xix) 45 CFR 170.315(b)(1) and (h)(1).
    (xx) 45 CFR 170.315(b)(1) and (h)(2).
    (xxi) 45 CFR 170.315(b)(1), (h)(1), and (h)(2); and
    (B) Clinical quality measures at--
    (1) 45 CFR 170.314(c)(1) or 170.315(c)(1);
    (2) 45 CFR 170.314(c)(2) or 170.315(c)(2);
    (3) Clinical quality measure certification criteria that support the 
calculation and reporting of clinical quality measures at 45 CFR 
170.314(c)(2) and (3); or 45 CFR 170.315(c)(3)(i) and (ii); and can be 
electronically accepted by CMS if the provider is submitting 
electronically.
    (C) Privacy and security at--
    (1) 45 CFR 170.314(d)(1) or 170.315(d)(1);
    (2) 45 CFR 170.314(d)(2) or 170.315(d)(2);
    (3) 45 CFR 170.314(d)(3) or 170.315(d)(3);
    (4) 45 CFR 170.314(d)(4) or 170.315(d)(4);
    (5) 45 CFR 170.314(d)(5) or 170.315(d)(5);
    (6) 45 CFR 170.314(d)(6) or 170.315(d)(6);
    (7) 45 CFR 170.314(d)(7) or 170.315(d)(7);
    (8) 45 CFR 170.314(d)(8) or 170.315(d)(8); and
    (D) The certification criteria that are necessary to be a Meaningful 
EHR User

[[Page 778]]

(as defined in this section), including the applicable measure 
calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 45 
CFR 170.315(g)(1) or (2) for all certification criteria that support a 
meaningful use objective with a percentage-based measure.
    (iii) The definition for 2019 and subsequent years specified in 
paragraph (2) of this definition.
    (2) For 2019 and subsequent years, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets the 2015 Edition Base EHR definition 
(as defined at 45 CFR 170.102) and has been certified to the 2015 
Edition health IT certification criteria--
    (i) At 45 CFR 170.315(a)(12) (family health history) and 45 CFR 
170.315(e)(3) (patient health information capture); and
    (ii) Necessary to be a Meaningful EHR User (as defined in this 
section), including the following:
    (A) The applicable measure calculation certification criterion at 45 
CFR 170.315(g)(1) or (2) for all certification criteria that support a 
meaningful use objective with a percentage-based measure.
    (B) Clinical quality measure certification criteria that support the 
calculation and reporting of clinical quality measures at 45 CFR 
170.315(c)(2) and (c)(3)(i) and (ii), and can be electronically accepted 
by CMS.
    Critical access hospital (CAH) means a facility that has been 
certified as a critical access hospital under section 1820(e) of the Act 
and for which Medicare payment is made under section 1814(l) of the Act 
for inpatient services and under section 1834(g) of the Act for 
outpatient services.
    EHR reporting period. Except with respect to payment adjustment 
years, EHR reporting period means either of the following:
    (1) For an eligible EP--
    (i) The following are applicable before 2015:
    (A) For the payment year in which the EP is first demonstrating he 
or she is a meaningful EHR user, any continuous 90-day period within the 
calendar year;
    (B) Except as specified in paragraphs (1)(iii) and (1)(iv) of this 
definition, for the subsequent payment years following the payment year 
in which the EP first successfully demonstrates he or she is a 
meaningful EHR user, the calendar year.
    (C) For an EP seeking to demonstrate he or she is a meaningful EHR 
user for the Medicare EHR incentive program for CY 2014, any of the 
following 3-month periods:
    (1) January 1, 2014 through March 31, 2014.
    (2) April 1, 2014 through June 30, 2014.
    (3) July 1, 2014 through September 30, 2014.
    (4) October 1, 2014 through December 31, 2014.
    (D) For an EP seeking to demonstrate he or she is a meaningful EHR 
user for the Medicaid EHR incentive program for CY 2014 any continuous 
90-day period within CY 2014.
    (ii) The following are applicable for 2015, 2016, 2017, and 2018:
    (A) For the CY 2015 payment year, any continuous 90-day period 
within CY 2015.
    (B) For the CY 2016 payment year:
    (1) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2016.
    (2) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2016.
    (C) For the CY 2017 payment year under the Medicaid EHR Incentive 
Program:
    (1) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2017.
    (2) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2017.
    (3) For the EP demonstrating the Stage 3 objectives and measures at 
Sec. 495.24, any continuous 90-day period within CY 2017.
    (D) For the CY 2018 payment year under the Medicaid EHR Incentive 
Program:
    (1) For the EP first demonstrating he or she is a meaningful EHR 
user, any

[[Page 779]]

continuous 90-day period within CY 2018.
    (2) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2018.
    (iii) For the CY 2019 payment year under the Medicaid Promoting 
Interoperability Program:
    (A) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2019.
    (B) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2019.
    (iv) For the CY 2020 payment year under the Medicaid Promoting 
Interoperability Program:
    (A) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2020.
    (B) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2020.
    (v) Under the Medicaid Promoting Interoperability Program, for the 
CY 2021 payment year:
    (A) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2021 that ends before 
October 31, 2021, or that ends before an earlier date in CY 2021 that is 
specified by the state and approved by CMS in the State Medicaid HIT 
plan described at Sec. 495.332.
    (B) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2021 that ends before October 31, 2021, or that ends before an 
earlier date in CY 2021 that is specified by the state and approved by 
CMS in the State Medicaid HIT plan described at Sec. 495.332.
    (2) For an eligible hospital or CAH--
    (i) The following are applicable before 2015:
    (A) For the payment year in which the eligible hospital or CAH is 
first demonstrating it is a meaningful EHR user, any continuous 90-day 
period within the Federal fiscal year;
    (B) Except as specified in paragraph (2)(iii) of this definition, 
for the subsequent payment years following the payment year in which the 
eligible hospital or CAH first successfully demonstrates it is a 
meaningful EHR user, the Federal fiscal year.
    (C) For an eligible hospital or CAH seeking to demonstrate it is a 
meaningful EHR user for FY 2014, any of the following 3-month periods:
    (1) October 1, 2013 through December 31, 2013.
    (2) January 1, 2014 through March 31, 2014.
    (3) April 1, 2014 through June 30, 2014.
    (4) July 1, 2014 through September 30, 2014.
    (ii) The following are applicable for 2015, 2016, 2017, and 2018:
    (A) For the FY 2015 payment year, any continuous 90-day period 
within the period beginning on October 1, 2014 and ending on December 
31, 2015.
    (B) For the FY 2016 payment year as follows:
    (1) For the eligible hospital or CAH first demonstrating it is a 
meaningful EHR user, any continuous 90-day period within CY 2016.
    (2) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, any 
continuous 90-day period within CY 2016.
    (C) For the FY 2017 payment year as follows:
    (1) Under the Medicaid EHR Incentive Program:
    (i) For the eligible hospital or CAH first demonstrating it is a 
meaningful EHR user, any continuous 90-day period within CY 2017.
    (ii) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, any 
continuous 90-day period within CY 2017.
    (iii) For the eligible hospital or CAH demonstrating the Stage 3 
objectives and measures at Sec. 495.24, any continuous 90-day period 
within CY 2017.
    (2) Under the Medicare EHR Incentive Program, for a Puerto Rico 
eligible hospital, any continuous 14-day period within CY 2017.
    (D) For the FY 2018 payment year as follows:
    (1) Under the Medicaid Promoting Interoperability Program:
    (i) For the eligible hospital or CAH first demonstrating it is a 
meaningful

[[Page 780]]

EHR user, any continuous 90-day period within CY 2018.
    (ii) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, any 
continuous 90-day period within CY 2018.
    (2) Under the Medicare Promoting Interoperability Program, for a 
Puerto Rico eligible hospital, any continuous 90-day period within CY 
2018.
    (iii) For the FY 2019 payment year as follows:
    (A) Under the Medicaid Promoting Interoperability Program:
    (1) For the eligible hospital or CAH first demonstrating it is a 
meaningful EHR user, any continuous 90-day period within CY 2019.
    (2) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, any 
continuous 90-day period within CY 2019.
    (B) Under the Medicare Promoting Interoperability Program, for a 
Puerto Rico eligible hospital, any continuous 90-day period within CY 
2019.
    (iv) For the FY 2020 payment year as follows:
    (A) Under the Medicaid Promoting Interoperability Program:
    (1) For the eligible hospital or CAH first demonstrating it is a 
meaningful EHR user, any continuous 90-day period within CY 2020.
    (2) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, any 
continuous 90-day period within CY 2020.
    (B) Under the Medicare Promoting Interoperability Program, for a 
Puerto Rico eligible hospital, any continuous 90-day period within CY 
2020.
    (v) For the FY 2021 payment year as follows: Under the Medicare 
Promoting Interoperability Program, for a Puerto Rico eligible hospital, 
any continuous 90-day period within CY 2021.
    EHR reporting period for a payment adjustment year. For a payment 
adjustment year, the EHR reporting period means the following:
    (1) For an EP--
    (i) The following are applicable before 2015:
    (A)(1) Except as provided in paragraphs (1)(i)(A)(2), (1)(i)(B), and 
(1)(i)(C) of this definition, the calendar year that is 2 years before 
the payment adjustment year.
    (2) The special EHR reporting period for CY 2014 (specified in 
paragraph (1)(i)(C) of this definition, as applicable) of the definition 
of ``EHR Reporting Period'' that occurs within the calendar year that is 
2 years before the payment adjustment year and is only for EHR reporting 
periods in CY 2014.
    (B) If an EP is demonstrating he or she is a meaningful EHR user for 
the first time in the calendar year, that is 2 years before the payment 
adjustment year, then any continuous 90-day period within such (2 years 
prior) calendar year.
    (C)(1) If in the calendar year that is 2 years before the payment 
adjustment year and in all prior calendar years, the EP has not 
successfully demonstrated he or she is a meaningful EHR user, then any 
continuous 90-day period that both begins in the calendar year 1 year 
before the payment adjustment year and ends at least 3 months before the 
end of such prior year.
    (2) Under this exception, the provider must successfully register 
for and attest to meaningful use no later than the date October 1 of the 
year before the payment adjustment year.
    (ii) The following are applicable for 2015, 2016, and 2017:
    (A) In 2015 as follows:
    (1) If an EP has not successfully demonstrated he or she is a 
meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2015 and applies for the CY 2016 and 
2017 payment adjustment years.
    (2) If in a prior year an EP has successfully demonstrated he or she 
is a meaningful EHR user, the EHR reporting period is any continuous 90-
day period within CY 2015 and applies for the CY 2017 payment adjustment 
year.
    (B) In 2016 as follows:
    (1) If an EP has not successfully demonstrated he or she is a 
meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2016 and applies for the CY 2017 and 
2018 payment adjustment years. For the CY 2017 payment adjustment year, 
the EHR reporting period must end before and the EP

[[Page 781]]

must successfully register for and attest to meaningful use no later 
than October 1, 2016.
    (2) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2016 and applies for the FY 2018 
payment adjustment year.
    (C) In 2017 as follows:
    (1) If an EP has not successfully demonstrated he or she is a 
meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2017 and applies for the CY 2018 
payment adjustment year. For the CY 2018 payment adjustment year, the 
EHR reporting period must end before and the EP must successfully 
register for and attest to meaningful use no later than October 1, 2017.
    (2) [Reserved]
    (2) For an eligible hospital--
    (i) The following are applicable before 2015:
    (A)(1) Except as provided in paragraphs (2)(i)(A)(2), (2)(i)(B), and 
(2)(i)(C) of this definition, the Federal fiscal year that is 2 years 
before the payment adjustment year.
    (2) The special EHR reporting period for FY 2014 (defined in 
paragraph (2)(i)(C) of the definition ``EHR Reporting Period'') that 
occurs within the fiscal year that is 2 years before the payment 
adjustment year and is only for EHR reporting periods in fiscal year 
2014.
    (B) If an eligible hospital is demonstrating it is a meaningful EHR 
user for the first time in the Federal fiscal year that is 2 years 
before the payment adjustment year, then any continuous 90-day period 
within such (2 years prior) Federal fiscal year.
    (C)(1) If in the Federal fiscal year that is 2 years before the 
payment adjustment year and for all prior Federal fiscal years the 
eligible hospital has not successfully demonstrated it is a meaningful 
EHR user, then any continuous 90-day period that both begins in the 
Federal fiscal year that is 1 year before the payment adjustment year 
and ends at least 3 months before the end of such prior Federal fiscal 
year.
    (2) Under this exception, the eligible hospital must successfully 
register for and attest to meaningful use no later than July 1 of the 
year before the payment adjustment year.
    (ii) The following are applicable for 2015, 2016, 2017, and 2018:
    (A) In 2015 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within the period beginning on October 1, 2014 
and ending on December 31, 2015 and applies for the FY 2016 and 2017 
payment adjustment years.
    (2) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within the period beginning on October 1, 
2014 and ending on December 31, 2015 and applies for the FY 2017 payment 
adjustment year.
    (B) In 2016 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2016 and 2017 applies for the FY 2017 
and 2018 payment adjustment years. For the FY 2017 payment adjustment 
year, the EHR reporting period must end before and the eligible hospital 
must successfully register for and attest to meaningful use no later 
than October 1, 2016.
    (2) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2016 and applies for the FY 2018 
payment adjustment year.
    (C) In 2017 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2017 and applies for the FY 2018 and 
2019 payment adjustment years. For the FY 2018 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2017.
    (2) If an eligible hospital is demonstrating Stage 3 of meaningful 
use under Sec. 495.24, the EHR reporting period is any continuous 90-
day period within

[[Page 782]]

CY 2017 and applies for the FY 2019 payment adjustment year.
    (3) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2017 and applies for the FY 2019 
payment adjustment year.
    (D) In 2018 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2018 and applies for the FY 2019 and 
2020 payment adjustment years. For the FY 2019 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2018.
    (2) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2018 and applies for the FY 2020 
payment adjustment year.
    (iii) The following are applicable for 2019:
    (A) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2019 and applies for the FY 2020 and 
FY 2021 payment adjustment years.
    (B) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2019 and applies for the FY 2021 
payment adjustment year.
    (iv) The following are applicable for 2020:
    (A) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2020 and applies for the FY 2021 and 
2022 payment adjustment years. For the FY 2021 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2020.
    (B) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2020 and applies for the FY 2022 
payment adjustment year.
    (v) The following are applicable for 2021:
    (A) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2021 and applies for the FY 2022 and 
2023 payment adjustment years. For the FY 2022 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2021.
    (B) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2021 and applies for the FY 2023 
payment adjustment year.
    (vi) The following are applicable for 2022:
    (A) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2022 and applies for the FY 2023 and 
2024 payment adjustment years. For the FY 2023 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2022.
    (B) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within CY 2022 and applies for the FY 2024 
payment adjustment year.
    (vii) The following are applicable for 2023:
    (A) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2023 and applies for the FY 2024 and 
2025 payment adjustment years. For the FY 2024 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2023.
    (B) If in a prior year an eligible hospital has successfully 
demonstrated it

[[Page 783]]

is a meaningful EHR user, the EHR reporting period is any continuous 90-
day period within CY 2023 and applies for the FY 2025 payment adjustment 
year.
    (viii) The following are applicable for 2024:
    (A) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 180-day period within CY 2024 and applies for the FY 2025 and 
2026 payment adjustment years. For the FY 2025 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2024.
    (B) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 180-day period within CY 2024 and applies for the FY 2026 
payment adjustment year.
    (3) For a CAH--
    (i) The following are applicable before 2015:
    (A) Except as provided in paragraph (3)(i)(B) of this definition, 
the Federal fiscal year that is the payment adjustment year.
    (B) If the CAH is demonstrating it is a meaningful EHR user for the 
first time in the payment adjustment year, any continuous 90-day period 
within the Federal fiscal year that is the payment adjustment year.
    (ii) The following are applicable for 2015, 2016, 2017, and 2018:
    (A) In 2015 as follows:
    (1) The EHR reporting period is any continuous 90-day period within 
the period beginning on October 1, 2014 and ending on December 31, 2015 
and applies for the FY 2015 payment adjustment year.
    (2) [Reserved]
    (B) In 2016 as follows:
    (1) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2016 and applies for the FY 2016 payment adjustment 
year.
    (2) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2016 and applies for the FY 2016 payment adjustment 
year.
    (C) In 2017 as follows:
    (1) If the CAH has not successfully demonstrated meaningful EHR use 
in a prior year the EHR reporting period is any continuous 90-day period 
within CY 2017 and applies for the FY 2017 payment adjustment year.
    (2) If a CAH is demonstrating Stage 3 of meaningful use under Sec. 
495.24, the EHR reporting period is any continuous 90-day period within 
CY 2017 and applies for that begins on the first day of second quarter 
of the FY 2017 payment adjustment year.
    (3) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2017 and applies for the FY 2017 payment adjustment 
year.
    (D) In 2018 as follows:
    (1) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2018 and applies for the FY 2018 payment adjustment 
year.
    (2) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2018 and applies for the FY 2018 payment adjustment 
year.
    (iii) The following are applicable for 2019:
    (A) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2019 and applies for the FY 2019 payment adjustment 
year.
    (B) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2019 and applies for the FY 2019 payment adjustment 
year.
    (iv) The following are applicable for 2020:
    (A) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2020 and applies for the FY 2020 payment adjustment 
year.

[[Page 784]]

    (B) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2020 and applies for the FY 2020 payment adjustment 
year.
    (v) The following are applicable for 2021:
    (A) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2021 and applies for the FY 2021 payment adjustment 
year.
    (B) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2021 and applies for the FY 2021 payment adjustment 
year.
    (vi) The following are applicable for 2022:
    (A) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2022 and applies for the FY 2022 payment adjustment 
year.
    (B) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2022 and applies for the FY 2022 payment adjustment 
year.
    (vii) The following are applicable for 2023:
    (A) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 90-
day period within CY 2023 and applies for the FY 2023 payment adjustment 
year.
    (B) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 90-day 
period within CY 2023 and applies for the FY 2023 payment adjustment 
year.
    (viii) The following are applicable for 2024:
    (A) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 
180-day period within CY 2024 and applies for the FY 2024 payment 
adjustment year.
    (B) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is any continuous 180-day 
period within CY 2024 and applies for the FY 2024 payment adjustment 
year.
    Eligible hospital means an eligible hospital as defined under Sec. 
495.100 or Medicaid eligible hospital under subpart D of this part.
    Eligible professional (EP) means an eligible professional as defined 
under Sec. 495.100 or a Medicaid eligible professional under subpart D 
of this part.
    First, second, third, fourth, fifth, or sixth payment years mean as 
follows:
    (1) The first payment year is: with respect to an EP, the first 
calendar year for which the EP receives an incentive payment under this 
part; and with respect to an eligible hospital or CAH, the first FY for 
which the hospital receives an incentive payment under this part.
    (2) The second, third, fourth, fifth, or sixth payment year is:
    (i) With respect to a Medicare EP, the second, third, fourth or 
fifth successive CY immediately following the first payment year; and 
with respect to a Medicare eligible hospital or CAH, the second, third, 
or fourth successive Federal FY immediately following the first payment 
year. (Note: Medicare EPs are not eligible for a sixth payment year and 
Medicare eligible hospitals are not eligible for a fifth or sixth 
payment year.)
    (ii)(A) With respect to a Medicaid EP, the second, third, fourth, 
fifth, or sixth CY for which the EP receives an incentive payment under 
subpart D, regardless of whether the year immediately follows the prior 
payment year; and
    (B) With respect to a Medicaid eligible hospital, for years prior to 
FY 2017, the second, third, fourth, fifth, or sixth Federal FY for which 
the hospital receives an incentive payment under subpart D of this part, 
regardless of whether the year immediately follows the prior payment 
year. Beginning with FY 2017, payments to Medicaid eligible hospitals 
must be consecutive, and the hospital is not eligible for an incentive 
payment under subpart D of this part unless it received such incentive 
payment for the prior fiscal year.
    Hospital-based EP. Unless it meets the requirements of Sec. 495.5, 
a hospital-based

[[Page 785]]

EP means an EP who furnishes 90 percent or more of his or her covered 
professional services in sites of service identified by the codes used 
in the HIPAA standard transaction as an inpatient hospital or emergency 
room setting in the year preceding the payment year, or in the case of a 
payment adjustment year, in either of the 2 years before the year 
preceding such payment adjustment year.
    (1) For Medicare, this is calculated based on--
    (i) The Federal fiscal year preceding the payment year; and
    (ii) For the payment adjustments, based on--
    (A) The Federal fiscal year 2 years before the payment adjustment 
year; or
    (B) The Federal fiscal year 3 years before the payment adjustment 
year.
    (2) For Medicaid, it is at the State's discretion if the data are 
gathered on the Federal fiscal year or calendar year preceding the 
payment year.
    (3) For the CY 2013 payment year only, an EP who furnishes services 
billed by a CAH receiving payment under Method II (as described in Sec. 
413.70(b)(3) of this chapter) is considered to be hospital-based if 90 
percent or more of his or her covered professional services are 
furnished in sites of service identified by the codes used in the HIPAA 
standard transaction as an inpatient hospital or emergency room setting 
in each of the Federal fiscal years 2012 and 2013.
    Meaningful EHR user means all of the following:
    (1) Subject to paragraph (3) of this definition, an EP, eligible 
hospital or CAH that, for an EHR reporting period for a payment year or 
payment adjustment year--
    (i) Demonstrates in accordance with Sec. 495.40 meaningful use of 
certified EHR technology by meeting the applicable objectives and 
associated measures under Sec. Sec. 495.20, 495.22, 495.24;
    (ii) Does not knowingly and willfully take action (such as to 
disable functionality) to limit or restrict the compatibility or 
interoperability of CEHRT;
    (iii) Engages in activities related to supporting providers with the 
performance of CEHRT; and
    (iv) Successfully reports the clinical quality measures selected by 
CMS to CMS or the States, as applicable, in the form and manner 
specified by CMS or the States, as applicable.
    (2)(i) Except as specified in paragraph (2)(ii) of this definition, 
a Medicaid EP or Medicaid eligible hospital, that meets the requirements 
of paragraph (1) of this definition and any additional criteria for 
meaningful use imposed by the State and approved by CMS under Sec. Sec. 
495.316 and 495.332.
    (ii) An eligible hospital or CAH is deemed to be a meaningful EHR 
user for purposes of receiving an incentive payment under subpart D of 
this part, if the hospital participates in both the Medicare and 
Medicaid EHR incentive programs, and the hospital meets the requirements 
of paragraph (1) of this definition.
    (3) To be considered a meaningful EHR user, at least 50 percent of 
an EP's patient encounters during an EHR reporting period for a payment 
year (or, in the case of a payment adjustment year, during an applicable 
EHR reporting period for such payment adjustment year) must occur at a 
practice/location or practices/locations equipped with certified EHR 
technology.
    Payment adjustment year means the following:
    (1) For an EP, a calendar year beginning with CY 2015.
    (2) For a CAH or an eligible hospital, a Federal fiscal year 
beginning with FY 2015.
    (3) For a Puerto Rico eligible hospital, a Federal fiscal year 
beginning with FY 2022.
    Payment year means the following:
    (1) For an EP, a calendar year beginning with CY 2011.
    (2) For a CAH or an eligible hospital, a Federal fiscal year 
beginning with FY 2011.
    (3) For a Puerto Rico eligible hospital, a Federal fiscal year 
beginning with FY 2016.

[[Page 786]]

    Qualified EHR has the same definition as this term is defined at 45 
CFR 170.102.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54148, Sept. 4, 2012; 
78 FR 75200, Dec. 10, 2013; 80 FR 62940, Oct. 16, 2015; 80 FR 71386, 
Nov. 16, 2015; 81 FR 34909, June 1, 2016; 81 FR 77555, Nov. 4, 2016; 81 
FR 79882, Nov. 14, 2016; 82 FR 38516, Aug. 14, 2017; 82 FR 46143, Oct. 
4, 2017; 83 FR 41706, Aug. 17, 2018; 83 FR 60096, Nov. 23, 2018; 84 FR 
42615, Aug. 16, 2019; 85 FR 59026, Sept. 18, 2020; 86 FR 45521, Aug. 13, 
2021]



Sec. 495.5  Requirements for EPs seeking to reverse a hospital-based
determination under Sec. 495.4.

    (a) Exception for certain EPs. Beginning with payment year 2013, an 
EP who meets the definition of hospital-based EP specified in Sec. 
495.4 but who can demonstrate to CMS that the EP funds the acquisition, 
implementation, and maintenance of Certified EHR Technology, including 
supporting hardware and interfaces needed for meaningful use without 
reimbursement from an eligible hospital or CAH, and uses such Certified 
EHR Technology in the inpatient or emergency department of a hospital 
(instead of the hospital's Certified EHR Technology), may be determined 
by CMS to be a nonhospital-based EP.
    (b) Process for determining a nonhospital-based EP. When an EP 
registers for a given payment year they should receive a determination 
of whether they have been determined ``hospital-based.''
    (1) An EP determined ``hospital-based,'' but who wishes to be 
determined nonhospital-based as specified in paragraph (a) of section, 
may use an administrative process to provide documentation and seek a 
nonhospital-based determination. Such administrative process will be 
available throughout the incentive payment year and including the 2 
months following the incentive payment year in which the EP may attest 
to being a meaningful EHR user.
    (2) If an EP is determined nonhospital-based under paragraph (a) of 
this section, to be considered nonhospital-based for subsequent payment 
years, the EP must attest in such payment year (or by the time the EP 
must attest it is a meaningful EHR user for such year) that the EP 
continues to meet the criteria of paragraph (a) of this section.
    (c) Requirements for nonhospital-based EPs. An EP determined 
nonhospital-based must--
    (1) Continue to meet all applicable requirements to receive an 
incentive payment, including meeting all requirements for meaningful 
use; and
    (2) Demonstrate meaningful use using all encounters at all locations 
equipped with Certified EHR Technology, including those in the inpatient 
and emergency departments of the hospital.

[77 FR 54149, Sept. 4, 2012]



Sec. 495.20  Meaningful use objectives and measures for EPs, eligible
hospitals, and CAHs before 2015.

    The following criteria are applicable before 2015:
    (a) Stage 1 criteria for EPs--(1) General rule regarding Stage 1 
criteria for meaningful use for EPs. Except as specified in paragraphs 
(a)(2) and (a)(3) of this section, EPs must meet all objectives and 
associated measures of the Stage 1 criteria specified in paragraph (d) 
of this section and five objectives of the EP's choice from paragraph 
(e) of this section to meet the definition of a meaningful EHR user.
    (2) Exclusion for non-applicable objectives. (i) An EP may exclude a 
particular objective contained in paragraphs (d) or (e) of this section, 
if the EP meets all of the following requirements:
    (A) Must ensure that the objective in paragraph (d) or (e) of this 
section includes an option for the EP to attest that the objective is 
not applicable.
    (B) Meets the criteria in the applicable objective that would permit 
the attestation.
    (C) Attests.
    (ii) (A) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply. For 
example, an EP that has an exclusion from one of the objectives in 
paragraph (e) of this section must meet four (and not five) objectives 
of the EP's choice from such paragraph to meet the definition of a 
meaningful EHR user.

[[Page 787]]

    (B) Beginning 2014, an exclusion does not reduce (by the number of 
exclusions applicable) the number of objectives that would otherwise 
apply in paragraph (e) of this section unless five or more objectives 
can be excluded. An EP must meet five of the objectives and associated 
measures specified in paragraph (e) of this section, one of which must 
be either paragraph (e)(9) or (10) of this section, unless the EP has an 
exclusion from five or more objectives specified in paragraph (e) of 
this section, in which case the EP must meet all remaining objectives 
and associated measures in paragraph (e) of this section.
    (3) Exception for Medicaid EPs who adopt, implement or upgrade in 
their first payment year. For Medicaid EPs who adopt, implement, or 
upgrade certified EHR technology in their first payment year, the 
meaningful use objectives and associated measures of the Stage 1 
criteria specified in paragraphs (d) and (e) apply beginning with the 
second payment year, and do not apply to the first payment year.
    (4) Flexible options for using certified EHR technology in 2014. For 
an EHR reporting period in 2014, if an EP could not fully implement 2014 
Edition certified EHR technology due to delays in availability and 
uses--
    (i) Only 2011 Edition certified EHR technology, the EP must satisfy 
the objectives and associated measures of the Stage 1 criteria that were 
applicable for 2013; or
    (ii) A combination of 2011 Edition certified EHR technology and 2014 
Edition certified EHR technology, the EP may choose to satisfy one of 
the following sets of objectives and associated measures:
    (A) The Stage 1 criteria that were applicable for 2013.
    (B) The Stage 1 criteria that are applicable beginning 2014.
    (C) If the EP is scheduled to begin Stage 2 in 2014, the Stage 2 
criteria.
    (b) Stage 1 criteria for eligible hospitals and CAHs--(1) General 
rule regarding Stage 1 criteria for meaningful use for eligible 
hospitals or CAHs. Except as specified in paragraphs (b)(2) and (b)(3) 
of this section, eligible hospitals and CAHs must meet all objectives 
and associated measures of the Stage 1 criteria specified in paragraph 
(f) of this section and five objectives of the eligible hospital's or 
CAH's choice from paragraph (g) of this section to meet the definition 
of a meaningful EHR user.
    (2) Exclusions for nonapplicable objectives. (i) An eligible 
hospital or CAH may exclude a particular objective that includes an 
option for exclusion contained in paragraphs (f) or (g) of this section, 
if the hospital meets all of the following requirements:
    (A) The hospital meets the criteria in the applicable objective that 
would permit an exclusion.
    (B) The hospital so attests.
    (ii)(A) An exclusion will reduce (by the number of exclusions 
received) the number of objectives that would otherwise apply. For 
example, an eligible hospital that is excluded from one of the 
objectives in paragraph (g) of this section must meet four (and not 
five) objectives of the hospital's choice from such paragraph to meet 
the definition of a meaningful EHR user.
    (B) Beginning 2014, an exclusion does not reduce (by the number of 
exclusions applicable) the number of objectives that would otherwise 
apply in paragraph (g) of this section. Eligible hospitals or CAHs must 
meet five of the objectives and associated measures specified in 
paragraph (g) of this section, one which must be specified in paragraph 
(g)(8), (9), or (10) of this section.
    (3) Exception for Medicaid eligible hospitals that adopt, implement 
or upgrade in their first payment year. For Medicaid eligible hospitals 
that adopt, implement, or upgrade certified EHR technology in their 
first payment year, the meaningful use objectives and associated 
measures of the Stage 1 criteria specified in paragraphs (f) and (g) of 
this section apply beginning with the second payment year, and do not 
apply to the first payment year.
    (4) Flexible options for using certified EHR technology in 2014. For 
an EHR reporting period in 2014, if an eligible hospital or CAH could 
not fully implement 2014 Edition certified EHR technology due to delays 
in availability and uses--
    (i) Only 2011 Edition certified EHR technology, the eligible 
hospital or

[[Page 788]]

CAH must satisfy the objectives and associated measures of the Stage 1 
criteria that were applicable for 2013;
    (ii) A combination of 2011 Edition certified EHR technology and 2014 
Edition certified EHR technology, the eligible hospital or CAH may 
choose to satisfy one of the following sets of objectives and associated 
measures:
    (A) The Stage 1 criteria that were applicable for 2013.
    (B) The Stage 1 criteria that are applicable beginning 2014.
    (C) If the eligible hospital or CAH is scheduled to begin Stage 2 in 
2014, the Stage 2 criteria.
    (c) Many of the objective and associated measures in paragraphs 
paragraphs (d) through (m) of this section rely on measures that count 
unique patients or actions.
    (1) If a measure (or associated objective) in paragraphs (d) through 
(g) of this section references paragraph (c) of this section, then the 
measure may be calculated by reviewing only the actions for patients 
whose records are maintained using certified EHR technology. A patient's 
record is maintained using certified EHR technology if sufficient data 
was entered in the certified EHR technology to allow the record to be 
saved, and not rejected due to incomplete data.
    (2) If the objective and associated measure does not reference this 
paragraph (c) of this section, then the measure must be calculated by 
reviewing all patient records, not just those maintained using certified 
EHR technology.
    (d) Stage 1 core criteria for EPs. An EP must satisfy the following 
objectives and associated measures, except those objectives and 
associated measures for which an EP qualifies for an exclusion under 
paragraph (a)(2) of this section specified in this paragraph:
    (1)(i) Objective. Use computerized provider order entry (CPOE) for 
medication orders directly entered by any licensed healthcare 
professional who can enter orders into the medical record per state, 
local and professional guidelines.
    (ii) Measure. (A) Subject to paragraph (c) of this section, more 
than 30 percent of all unique patients with at least one medication in 
their medication list seen by the EP have at least one medication order 
entered using CPOE.
    (B) Subject to paragraph (c) of this section, more than 30 percent 
of medication orders created by the EP during the EHR reporting period 
are recorded using computerized provider order entry, or the measure 
specified in paragraph (d)(1)(ii)(A) of this section.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section 
Any EP who writes fewer than 100 prescriptions during the EHR reporting 
period.
    (2)(i) Objective. Implement drug-drug and drug-allergy interaction 
checks.
    (ii) Measure. The EP has enabled this functionality for the entire 
EHR reporting period.
    (3)(i) Objective. Maintain an up-to-date problem list of current and 
active diagnoses.
    (ii) Measure. More than 80 percent of all unique patients seen by 
the EP have at least one entry or an indication that no problems are 
known for the patient recorded as structured data.
    (4)(i) Objective. Generate and transmit permissible prescriptions 
electronically (eRx).
    (ii) Measure. Subject to paragraph (c) of this section, more than 40 
percent of all permissible prescriptions written by the EP are 
transmitted electronically using certified EHR technology.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section 
(A) Any EP who writes fewer than 100 prescriptions during the EHR 
reporting period.
    (B) Beginning 2013, any EP who does not have a pharmacy within their 
organization and there are no pharmacies that accept electronic 
prescriptions within 10 miles of the EP's practice location at the start 
of his/her EHR reporting period, or the exclusion specified in 
(d)(4)(iii)(A) of this section.
    (5)(i) Objective. Maintain active medication list.
    (ii) Measure. More than 80 percent of all unique patients seen by 
the EP have at least one entry (or an indication that the patient is not 
currently prescribed any medication) recorded as structured data.
    (6)(i) Objective. Maintain active medication allergy list.
    (ii) Measure. More than 80 percent of all unique patients seen by 
the EP have at least one entry (or an indication

[[Page 789]]

that the patient has no known medication allergies) recorded as 
structured data.
    (7)(i) Objective. Record all of the following demographics:
    (A) Preferred language.
    (B) Gender.
    (C) Race.
    (D) Ethnicity.
    (E) Date of birth.
    (ii) Measure. More than 50 percent of all unique patients seen by 
the EP have demographics recorded as structured data.
    (8)(i) Objective. Record and chart changes in the following vital 
signs:
    (A) Height.
    (B) Weight.
    (C) Blood pressure.
    (D) Calculate and display body mass index (BMI).
    (E)(1) Plot and display growth charts for children 2-20 years, 
including BMI.
    (2) For 2013, plot and display growth charts for patients 0-20 
years, including body mass index, or paragraph (d)(8)(i)(E)(1) of this 
section.
    (3) Beginning 2014, plot and display growth charts for patients 0-20 
years, including body mass index.
    (ii) Measure. (A) Subject to paragraph (c) of this section, more 
than 50 percent of all unique patients age 2 and over seen by the EP, 
height, weight and blood pressure are recorded as structured data.
    (B) For 2013--(1) Subject to paragraph (c) of this section, more 
than 50 percent of all unique patients seen by the EP during the EHR 
reporting period have blood pressure (for patients age 3 and over only) 
and height/length and weight (for all ages) recorded as structured data; 
or
    (2) The measure specified in paragraph (d)(8)(ii)(A) of this 
section.
    (C) Beginning 2014, only the measure specified in paragraph 
(d)(8)(ii)(B)(1) of this section.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
(A) Any EP who either see no patients 2 years or older, or who believes 
that all three vital signs of height, weight, and blood pressure of 
their patients have no relevance to their scope of practice.
    (B) For 2013, either of the following:
    (1) The exclusion specified in paragraph (d)(8)(iii)(A) of this 
section.
    (2) The exclusion for an EP who--
    (i) Sees no patients 3 years or older is excluded from recording 
blood pressure;
    (ii) Believes that all three vital signs of height/length, weight, 
and blood pressure have no relevance to their scope of practice is 
excluded from recording them;
    (iii) Believes that height/length and weight are relevant to their 
scope of practice, but blood pressure is not, is excluded from recording 
blood pressure; or
    (iv) Believes that blood pressure is relevant to their scope of 
practice, but height/length and weight are not, is excluded from 
recording height/length and weight.
    (C) Beginning 2014, only the exclusion specified in paragraph 
(d)(8)(iii)(B)(2) of this section.
    (9)(i) Objective. Record smoking status for patients 13 years old or 
older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 50 
percent of all unique patients 13 years old or older seen by the EP have 
smoking status recorded as structured data.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
Any EP who sees no patients 13 years or older.
    (10)(i) Objective. (A) Report ambulatory clinical quality measures 
to CMS or, in the case of Medicaid EPs, the States.
    (B) Beginning 2013, this objective is reflected in the definition of 
a meaningful EHR user in Sec. 495.4 and is no longer listed as an 
objective in this paragraph (d).
    (ii) Measure. (A) Subject to paragraph (c) of this section, 
successfully report to CMS (or, in the case of Medicaid EPs, the States) 
ambulatory clinical quality measures selected by CMS in the manner 
specified by CMS (or in the case of Medicaid EPs, the States).
    (B) Beginning 2013, this measure is reflected in the definition of a 
meaningful EHR user in Sec. 495.4 and no longer listed as a measure in 
this paragraph (d).
    (11)(i) Objective. Implement one clinical decision support rules 
relevant to specialty or high clinical priority along with the ability 
to track compliance with that rule.

[[Page 790]]

    (ii) Measure. Implement one clinical decision support rule.
    (12)(i) Objective. (A) Provide patients with an electronic copy of 
their health information (including diagnostics test results, problem 
list, medication lists, medication allergies) upon request.
    (B) Beginning 2014, provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    (ii) Measure. (A) Subject to paragraph (c) of this section, more 
than 50 percent of all patients who request an electronic copy of their 
health information are provided it within 3 business days.
    (B) Beginning 2014, subject to paragraph (c) of this section, more 
than 50 percent of all unique patients seen by the EP during the EHR 
reporting period are provided timely (available to the patient within 4 
business days after the information is available to the EP) online 
access to their health information subject to the EP's discretion to 
withhold certain information.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
(A) Any EP that has no requests from patients or their agents for an 
electronic copy of patient health information during the EHR reporting 
period.
    (B) Beginning 2014, any EP who neither orders nor creates any of the 
information listed for inclusion as part of this measure.
    (13)(i) Objective. Provide clinical summaries for patients for each 
office visit.
    (ii) Measure. Subject to paragraph (c) of this section, clinical 
summaries provided to patients for more than 50 percent of all office 
visits within 3 business days.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (14)(i) Objective. (A) Capability to exchange key clinical 
information (for example, problem list, medication list, medication 
allergies, and diagnostic test results), among providers of care and 
patient authorized entities electronically.
    (B) Beginning 2013, this objective is no longer required as part of 
the core set.
    (ii) Measure. (A) Performed at least one test of certified EHR 
technology's capacity to electronically exchange key clinical 
information.
    (B) Beginning 2013, this measure is no longer required as part of 
the core set.
    (15)(i) Objective. Protect electronic health information created or 
maintained by the certified EHR technology through the implementation of 
appropriate technical capabilities.
    (ii) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1) and 
implement security updates as necessary and correct identified security 
deficiencies as part of its risk management process.
    (e) Stage 1 menu set criteria for EPs. An EP must meet five of the 
following objectives and associated measures, one of which must be 
either paragraph (e)(9) or (e)(10) of this section, except that the 
required number of objectives and associated measures is reduced by an 
EP's paragraph (a)(2) of this section exclusions specified in this 
paragraph. Beginning 2014, an EP must meet five of the following 
objectives and associated measures, one of which must be either 
paragraph (e)(9) or (10) of this section unless the EP has an exclusion 
from five or more objectives in this paragraph (e), in which case the EP 
must meet all remaining objectives and associated measures in paragraph 
(e) of this section.
    (1)(i) Objective. Implement drug-formulary checks.
    (ii) Measure. The EP has enabled this functionality and has access 
to at least one internal or external formulary for the entire EHR 
reporting period.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
Any EP who writes fewer than 100 prescriptions during the EHR reporting 
period.
    (2)(i) Objective. Incorporate clinical lab-test results into EHR as 
structured data.
    (ii) Measure. Subject to paragraph (c) of this section, more than 40 
percent of all clinical lab tests results ordered by the EP during the 
EHR reporting period whose results are either in a positive/negative or 
numerical format are incorporated in certified EHR technology as 
structured data.

[[Page 791]]

    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
An EP who orders no lab tests whose results are either in a positive/
negative or numeric format during the EHR reporting period.
    (3)(i) Objective. Generate lists of patients by specific conditions 
to use for quality improvement, reduction of disparities, research, or 
outreach.
    (ii) Measure. Subject to paragraph (c) of this section, generate at 
least one report listing patients of the EP with a specific condition.
    (4)(i) Objective. Send reminders to patients per patient preference 
for preventive/follow-up care.
    (ii) Measure. Subject to paragraph (c) of this section, more than 20 
percent of all patients 65 years or older or 5 years old or younger were 
sent an appropriate reminder during the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
An EP who has no patients 65 years old or older or 5 years old or 
younger with records maintained using certified EHR technology.
    (5)(i) Objective. (A) Provide patients with timely electronic access 
to their health information (including lab results, problem list, 
medication lists, and allergies) within 4 business days of the 
information being available to the EP.
    (B) Beginning 2014, this objective is no longer included in the menu 
set.
    (ii) Measure. (A) At least 10 percent of all unique patients seen by 
the EP are provided timely (available to the patient within four 
business days of being updated in the certified EHR technology) 
electronic access to their health information subject to the EP's 
discretion to withhold certain information.
    (B) Beginning 2014, this measure is no longer included in the menu 
set.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
Any EP that neither orders nor creates any of the information listed at 
45 CFR 170.314(g) during the EHR reporting period.
    (6)(i) Objective. Use certified EHR technology to identify patient-
specific education resources and provide those resources to the patient 
if appropriate.
    (ii) Measure. More than 10 percent of all unique patients seen by 
the EP are provided patient-specific education resources.
    (7)(i) Objective. The EP who receives a patient from another setting 
of care or provider of care or believes an encounter is relevant should 
perform medication reconciliation.
    (ii) Measure. Subject to paragraph (c) of this section, the EP 
performs medication reconciliation for more than 50 percent of 
transitions of care in which the patient is transitioned into the care 
of the EP.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
An EP who was not the beneficiary of any transitions of care during the 
EHR reporting period.
    (8)(i) Objective. The EP who transitions their patient to another 
setting of care or provider of care or refers their patient to another 
provider of care should provide summary care record for each transition 
of care or referral.
    (ii) Measure. Subject to paragraph (c) of this section, the EP who 
transitions or refers their patient to another setting of care or 
provider of care provides a summary of care record for more than 50 
percent of transitions of care and referrals.
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
An EP who neither transfers a patient to another setting nor refers a 
patient to another provider during the EHR reporting period.
    (9)(i) Objective. (A) Capability to submit electronic data to 
immunization registries or immunization information systems and actual 
submission according to applicable law and practice.
    (B) Beginning 2013, capability to submit electronic data to 
immunization registries or immunization information systems and actual 
submission except where prohibited and according to applicable law and 
practice.
    (ii) Measure. Performed at least one test of certified EHR 
technology's capacity to submit electronic data to immunization 
registries and follow up submission if the test is successful (unless 
none of the immunization registries to which the EP submits such

[[Page 792]]

information has the capacity to receive the information electronically).
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
An EP who administers no immunizations during the EHR reporting period 
or where no immunization registry has the capacity to receive the 
information electronically.
    (10)(i) Objective. (A) Capability to submit electronic syndromic 
surveillance data to public health agencies and actual submission 
according to applicable law and practice.
    (B) Beginning 2013, capability to submit electronic syndromic 
surveillance data to public health agencies and actual submission except 
where prohibited and according to applicable law and practice.
    (ii) Measure. Performed at least one test of certified EHR 
technology's capacity to provide electronic syndromic surveillance data 
to public health agencies and follow-up submission if the test is 
successful (unless none of the public health agencies to which an EP 
submits such information has the capacity to receive the information 
electronically).
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
An EP who does not collect any reportable syndromic information on their 
patients during the EHR reporting period or does not submit such 
information to any public health agency that has the capacity to receive 
the information electronically.
    (f) Stage 1 core criteria for eligible hospitals or CAHs. An 
eligible hospital or CAH must meet the following objectives and 
associated measures except those objectives and associated measures for 
which an eligible hospital or CAH qualifies for a paragraph (b)(2) of 
this section exclusion specified in this paragraph:
    (1)(i) Objective. Use CPOE for medication orders directly entered by 
any licensed healthcare professional who can enter orders into the 
medical record per State, local, and professional guidelines.
    (ii) Measure. (A) Subject to paragraph (c) of this section, more 
than 30 percent of all unique patients with at least one medication in 
their medication list admitted to the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) have at least one 
medication order entered using CPOE.
    (B) Subject to paragraph (c) of this section, more than 30 percent 
of medication orders created by the authorized providers of the eligible 
hospital or CAH for patients admitted to their inpatient or emergency 
departments (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry, or the measure specified in 
paragraph (f)(1)(ii)(A) of this section.
    (2)(i) Objective. Implement drug-drug and drug-allergy interaction 
checks.
    (ii) Measure. The eligible hospital or CAH has enabled this 
functionality for the entire EHR reporting period.
    (3)(i) Objective. Maintain an up-to-date problem list of current and 
active diagnoses.
    (ii) Measure. More than 80 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) have at least one entry or an indication that no problems 
are known for the patient recorded as structured data.
    (4)(i) Objective. Maintain active medication list.
    (ii) Measure. More than 80 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) have at least one entry (or an indication that the 
patient is not currently prescribed any medication) recorded as 
structured data.
    (5)(i) Objective. Maintain active medication allergy list.
    (ii) Measure. More than 80 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) have at least one entry (or an indication that the 
patient has no known medication allergies) recorded as structured data.
    (6)(i) Objective. Record all of the following demographics;
    (A) Preferred language.
    (B) Gender.
    (C) Race.
    (D) Ethnicity.
    (E) Date of birth.

[[Page 793]]

    (F) Date and preliminary cause of death in the event of mortality in 
the eligible hospital or CAH.
    (ii) Measure. More than 50 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) have demographics recorded as structured data.
    (7)(i) Objective. Record and chart changes in the following vital 
signs:
    (A) Height.
    (B) Weight.
    (C) Blood pressure.
    (D) Calculate and display body mass index (BMI).
    (E)(1) Plot and display growth charts for children 2-20 years, 
including BMI.
    (2) For 2013, plot and display growth charts for patients 0-20 
years, including body mass index, or paragraph (f)(7)(i)(E)(1) of this 
section.
    (3) Beginning 2014, plot and display growth charts for patients 0-20 
years, including body mass index.
    (ii) Measure. (A) Subject to paragraph (c) of this section, for more 
than 50 percent of all unique patients age 2 and over admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23), height, weight, and blood pressure are recorded as structured 
data.
    (B) For 2013--
    (1) Subject to paragraph (c) of this section, more than 50 percent 
of all unique patients admitted to the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period have blood pressure (for patients age 3 and over only) 
and height/length and weight (for all ages) recorded as structured data; 
or
    (2) The measure specified in paragraph (f)(7)(ii)(A) of this 
section.
    (C) Beginning 2014, only the measure specified in paragraph 
(f)(7)(ii)(B)(1) of this section.
    (8)(i) Objective. Record smoking for patients 13 years old or older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 50 
percent of all unique patients 13 years old or older or admitted to the 
eligible hospital's inpatient or emergency department (POS 21 or 23) 
have smoking status recorded as structured data.
    (iii) Exclusion in accordance with paragraph (b)(2) of this section. 
Any eligible hospital or CAH that admits no patients 13 years or older 
to their inpatient or emergency department (POS 21 or 23).
    (9)(i) Objective. (A) Report hospital clinical quality measures to 
CMS or, in the case of Medicaid eligible hospitals, the States.
    (B) Beginning 2013, this objective is reflected in the definition of 
a meaningful EHR user in Sec. 495.4 and no longer listed as an 
objective in this paragraph (f).
    (ii) Measure. (A) Subject to paragraph (c) of this section, 
successfully report to CMS (or, in the case of Medicaid eligible 
hospitals or CAHs, the States) hospital clinical quality measures 
selected by CMS in the manner specified by CMS (or, in the case of 
Medicaid eligible hospitals or CAHs, the States).
    (B) Beginning 2013, this measure is reflected in the definition of a 
meaningful EHR user in Sec. 495.4 and no longer listed as a measure in 
this paragraph (f).
    (10)(i) Objective. Implement one clinical decision support rule 
related to a high priority hospital condition along with the ability to 
track compliance with that rule.
    (ii) Measure. Implement one clinical decision support rule.
    (11)(i) Objective. (A) Provide patients with an electronic copy of 
their health information (including diagnostic test results, problem 
list, medication lists, medication allergies, discharge summary, 
procedures), upon request.
    (B) Beginning 2014, this objective is no longer required as part of 
the core set.
    (ii) Measure. (A) Subject to paragraph (c) of this section, more 
than 50 percent of all patients of the inpatient or emergency 
departments of the eligible hospital or CAH (POS 21 or 23) who request 
an electronic copy of their health information are provided it within 3 
business days.
    (B) Beginning 2014, this measure is no longer required as part of 
the core set.
    (iii) Exclusion in accordance with paragraph (b)(2) of this section. 
Any eligible hospital or CAH that has no requests from patients or their 
agents for an

[[Page 794]]

electronic copy of patient health information during the EHR reporting 
period.
    (12)(i) Objective. (A) Provide patients with an electronic copy of 
their discharge instructions at time of discharge, upon request.
    (B) Beginning 2014, provide patients the ability to view online, 
download, and transmit information about a hospital admission.
    (ii) Measure. (A) Subject to paragraph (c) of this section, more 
than 50 percent of all patients who are discharged from an eligible 
hospital or CAH's inpatient or emergency department (POS 21 or 23) and 
who request an electronic copy of their discharge instructions are 
provided it.
    (B) Beginning 2014, subject to paragraph (c) of this section, more 
than 50 percent of all unique patients who are discharged from the 
inpatient or emergency department (POS 21 or 23) of an eligible hospital 
or CAH have their information available online within 36 hours of 
discharge.
    (iii) Exclusion in accordance with paragraph (b)(2) of this section. 
(A) Any eligible hospital or CAH that has no requests from patients or 
their agents for an electronic copy of the discharge instructions during 
the EHR reporting period.
    (B) Beginning 2014, this exclusion is no longer available.
    (13)(i) Objective. (A) Capability to exchange key clinical 
information (for example, problem list, medication list, medication 
allergies, and diagnostic test results), among providers of care and 
patient authorized entities electronically.
    (B) Beginning 2013, this objective is no longer required as part of 
the core set.
    (ii) Measure. Performed at least one test of certified EHR 
technology's capacity to electronically exchange key clinical 
information.
    (B) Beginning 2013, this measure is no longer required as part of 
the core set.
    (14)(i) Objective. Protect electronic health information created or 
maintained by the certified EHR technology through the implementation of 
appropriate technical capabilities.
    (ii) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1) and 
implement security updates as necessary and correct identified security 
deficiencies as part of its risk management process.
    (g) Stage 1 menu set criteria for eligible hospitals or CAHs. 
Eligible hospitals or CAHs must meet five of the following objectives 
and associated measures, one which must be specified in paragraph 
(g)(8), (g)(9), or (g)(10) of this section, except that the required 
number of objectives and associated measures is reduced by a hospital's 
paragraph (b)(2) of this section exclusions specified in this paragraph. 
Beginning 2014, eligible hospitals or CAHs must meet five of the 
following objectives and associated measures, one which must be 
specified in paragraph (g)(8), (9), or (10) of this section:
    (1)(i) Objective. Implement drug-formulary checks.
    (ii) Measure. The eligible hospital or CAH has enabled this 
functionality and has access to at least one internal or external 
formulary for the entire EHR reporting period.
    (2)(i) Objective. Record advance directives for patient 65 years old 
or older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 50 
percent of all unique patients 65 years old or older admitted to the 
eligible hospital's or CAH's inpatient (POS 21) have an indication of an 
advance directive status recorded as structured data.
    (iii) Exclusion in accordance with paragraph (b)(2) of this section. 
An eligible hospital or CAH that admits no patients age 65 years old or 
older during the EHR reporting period.
    (3)(i) Objective. Incorporate clinical lab-test results into EHR as 
structured data.
    (ii) Measure. Subject to paragraph (c) of this section, more than 40 
percent of all clinical lab test results ordered by an authorized 
provider of the eligible hospital or CAH for patients admitted to its 
inpatient or emergency department (POS 21 and 23) during the EHR 
reporting period whose results are either in a positive/negative or 
numerical format are incorporated in certified EHR technology as 
structured data.
    (4)(i) Objective. Generate lists of patients by specific conditions 
to use for

[[Page 795]]

quality improvement, reduction of disparities, research, or outreach.
    (ii) Measure. Subject to paragraph (c) of this section, generate at 
least one report listing patients of the eligible hospital or CAH with a 
specific condition.
    (5)(i) Objective. Use certified EHR technology to identify patient-
specific education resources and provide those resources to the patient 
if appropriate.
    (ii) Measure. More than 10 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) are provided patient-specific education resources.
    (6)(i) Objective. The eligible hospital or CAH who receives a 
patient from another setting of care or provider of care or believes an 
encounter is relevant should perform medication reconciliation.
    (ii) Measure. Subject to paragraph (c) of this section, the eligible 
hospital or CAH performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
    (7)(i) Objective. The eligible hospital or CAH that transitions 
their patient to another setting of care or provider of care or refers 
their patient to another provider of care should provide summary care 
record for each transition of care or referral.
    (ii) Measure. Subject to paragraph (c) of this section, the eligible 
hospital or CAH that transitions or refers their patient to another 
setting of care or provider of care provides a summary of care record 
for more than 50 percent of transitions of care and referrals.
    (8)(i) Objective. (A) Capability to submit electronic data to 
immunization registries or immunization information systems and actual 
submission according to applicable law and practice.
    (B) Beginning 2013, Capability to submit electronic data to 
immunization registries or immunization information systems and actual 
submission except where prohibited and according to applicable law and 
practice.
    (ii) Measure. Performed at least one test of certified EHR 
technology's capacity to submit electronic data to immunization 
registries and follow up submission if the test is successful (unless 
none of the immunization registries to which the eligible hospital or 
CAH submits such information has the capacity to receive the information 
electronically).
    (iii) Exclusion in accordance with paragraph (b)(2) of this section. 
An eligible hospital or CAH that administers no immunizations during the 
EHR reporting period or where no immunization registry has the capacity 
to receive the information electronically.
    (9)(i) Objective. (A) Capability to submit electronic data on 
reportable (as required by State or local law) lab results to public 
health agencies and actual submission according to applicable law and 
practice.
    (B) Beginning 2013, capability to submit electronic data on 
reportable (as required by State or local law) lab results to public 
health agencies and actual submission except where prohibited according 
to applicable law and practice.
    (ii) Measure. Performed at least one test of certified EHR 
technology's capacity to provide electronic submission of reportable lab 
results to public health agencies and follow-up submission if the test 
is successful (unless none of the public health agencies to which an 
eligible hospital or CAH submits such information has the capacity to 
receive the information electronically).
    (iii) Exclusion in accordance with paragraph (b)(2) of this section. 
No public health agency to which the eligible hospital or CAH submits 
such information has the capacity to receive the information 
electronically.
    (10)(i) Objective. (A) Capability to submit electronic syndromic 
surveillance data to public health agencies and actual submission 
according to applicable law and practice.
    (B) Beginning 2013, capability to submit electronic syndromic 
surveillance data to public health agencies and actual submission except 
where prohibited and according to applicable law and practice.
    (ii) Measure. Performed at least one test of certified EHR 
technology's capacity to provide electronic syndromic surveillance data 
to public health

[[Page 796]]

agencies and follow-up submission if the test is successful (unless none 
of the public health agencies to which an eligible hospital or CAH 
submits information has the capacity to receive the information 
electronically).
    (iii) Exclusion in accordance with paragraph (a)(2) of this section. 
No public health agency to which the eligible hospital or CAH submits 
information has the capacity to receive the information electronically.
    (h) Stage 2 criteria for EPs--(1) General rule regarding Stage 2 
criteria for meaningful use for EPs. Except as specified in paragraph 
(h)(2) of this section, EPs must meet all objectives and associated 
measures of the Stage 2 criteria specified in paragraph (j) of this 
section and 3 objectives of the EP's choice from paragraph (k) of this 
section to meet the definition of a meaningful EHR user.
    (2) Exclusion for nonapplicable objectives. (i) An EP may exclude a 
particular objective contained in paragraph (j) or (k) of this section, 
if the EP meets all of the following requirements:
    (A) Must ensure that the objective in paragraph (j) or (k) of this 
section includes an option for the EP to attest that the objective is 
not applicable.
    (B) Meets the criteria in the applicable objective that would permit 
the attestation.
    (C) Attests.
    (ii)(A) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (j) of this section. For example, an EP that has an exclusion 
from one of the objectives in paragraph (j) of this section must meet 16 
objectives from such paragraph to meet the definition of a meaningful 
EHR user.
    (B) An exclusion does not reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (k) of this section unless four or more exclusions apply. For 
example, an EP that has an exclusion for one of the objectives in 
paragraph (k) of this section must meet three of the five nonexcluded 
objectives from such paragraph to meet the definition of a meaningful 
EHR user. If an EP has an exclusion for four of the objectives in 
paragraph (k) of this section, then he or she must meet the remaining 
two nonexcluded objectives from such paragraph to meet the definition of 
a meaningful EHR user.
    (3) Flexible options for using certified EHR technology in 2014. For 
an EHR reporting period in 2014, if an EP is scheduled to begin Stage 2 
in 2014, but is unable to fully implement all the functions of 2014 
Edition certified EHR technology required for the objectives and 
associated measures of the Stage 2 criteria due to delays in 
availability, the EP may choose to satisfy the objectives and associated 
measures of the Stage 1 criteria that are applicable beginning 2014 
using 2014 Edition certified EHR technology.
    (i) Stage 2 criteria for eligible hospitals and CAHs--(1) General 
rule regarding Stage 2 criteria for meaningful use for eligible 
hospitals or CAHs. Except as specified in paragraph (i)(2) of this 
section, eligible hospitals and CAHs must meet all objectives and 
associated measures of the Stage 2 criteria specified in paragraph (l) 
of this section and three objectives of the eligible hospital's or CAH's 
choice from paragraph (m) of this section to meet the definition of a 
meaningful EHR user.
    (2) Exclusions for nonapplicable objectives. (i) An eligible 
hospital or CAH may exclude a particular objective that includes an 
option for exclusion contained in paragraphs (l) or (m) of this section, 
if the hospital meets all of the following requirements:
    (A) The hospital meets the criteria in the applicable objective that 
would permit an exclusion.
    (B) The hospital so attests.
    (ii)(A) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (l) of this section. For example, an eligible hospital that 
has an exclusion from 1 of the objectives in paragraph (l) of this 
section must meet 15 objectives from such paragraph to meet the 
definition of a meaningful EHR user.
    (B) An exclusion does not reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (m) of this section. For example, an eligible

[[Page 797]]

hospital that has an exclusion for one of the objectives in paragraph 
(m) of this section must meet three of the five nonexcluded objectives 
from such paragraph to meet the definition of a meaningful EHR user.
    (3) Flexible options for using certified EHR technology in 2014. For 
an EHR reporting period in 2014, if an eligible hospital or CAH is 
scheduled to begin Stage 2 in 2014, but is unable to fully implement all 
the functions of 2014 Edition certified EHR technology required for the 
objectives and associated measures of the Stage 2 criteria due to delays 
in availability, the eligible hospital or CAH may choose to satisfy the 
objectives and associated measures of the Stage 1 criteria that are 
applicable beginning 2014 using 2014 Edition certified EHR technology.
    (j) Stage 2 core criteria for EPs. An EP must satisfy the following 
objectives and associated measures, except those objectives and 
associated measures for which an EP qualifies for an exclusion under 
paragraph (h)(2) of this section specified in this paragraph (j).
    (1)(i) Objective. Use computerized provider order entry for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per State, local, and professional guidelines.
    (ii) Measures. Subject to paragraph (c) of this section--
    (A) More than 60 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry;
    (B) More than 30 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry; and
    (C) More than 30 percent of radiology orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry.
    (iii) Exclusions in accordance with paragraph (h)(2) of this 
section. (A) For the measure specified in paragraph (j)(1)(ii)(A) of 
this section, any EP who writes fewer than 100 medication orders during 
the EHR reporting period.
    (B) For the measure specified in paragraph (j)(1)(ii)(B) of this 
section, any EP who writes fewer than 100 laboratory orders during the 
EHR reporting period.
    (C) For the measure specified in paragraph (j)(1)(ii)(C), any EP who 
writes fewer than 100 radiology orders during the EHR reporting period.
    (2)(i) Objective. Generate and transmit permissible prescriptions 
electronically (eRx).
    (ii) Measure. Subject to paragraph (c) of this section, more than 50 
percent of all permissible prescriptions, or all prescriptions, written 
by the EP are queried for a drug formulary and transmitted 
electronically using Certified EHR Technology.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who--
    (A) Writes fewer than 100 permissible prescriptions during the EHR 
reporting period; or (B) Does not have a pharmacy within their 
organization and there are no pharmacies that accept electronic 
prescriptions within 10 miles of the EP's practice location at the start 
of his or her EHR reporting period.
    (3)(i) Objective. Record all of the following demographics:
    (A) Preferred language.
    (B) Sex.
    (C) Race.
    (D) Ethnicity.
    (E) Date of birth.
    (ii) Measure. More than 80 percent of all unique patients seen by 
the EP during the EHR reporting period have demographics recorded as 
structured data.
    (4)(i) Objective. Record and chart changes in the following vital 
signs:
    (A) Height/Length.
    (B) Weight.
    (C) Blood pressure (ages 3 and over).
    (D) Calculate and display body mass index (BMI).
    (E) Plot and display growth charts for patients 0-20 years, 
including body mass index.
    (ii) Measure. Subject to paragraph (c) of this section, more than 80 
percent of all unique patients seen by the EP during the EHR reporting 
period have blood pressure (for patients age 3 and over only) and 
height/length and

[[Page 798]]

weight (for all ages) recorded as structured data.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who--
    (A) Sees no patients 3 years or older is excluded from recording 
blood pressure;
    (B) Believes that all three vital signs of height/length, weight, 
and blood pressure have no relevance to their scope of practice is 
excluded from recording them;
    (C) Believes that height/length and weight are relevant to their 
scope of practice, but blood pressure is not, is excluded from recording 
blood pressure; or
    (D) Believes that blood pressure is relevant to their scope of 
practice, but height/length and weight are not, is excluded from 
recording height/length and weight.
    (5)(i) Objective. Record smoking status for patients 13 years old or 
older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 80 
percent of all unique patients 13 years old or older seen by the EP 
during the EHR reporting period have smoking status recorded as 
structured data.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who sees no patients 13 years old or older.
    (6)(i) Objective. Use clinical decision support to improve 
performance on high priority health conditions.
    (ii) Measures. (A) Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an EP's scope of 
practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions; and
    (B) The EP has enabled and implemented the functionality for drug-
drug and drug-allergy interaction checks for the entire EHR reporting 
period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section 
for paragraph (j)(6)(ii)(B) of this section. An EP who writes fewer than 
100 medication orders during the EHR reporting period.
    (7)(i) Objective. Incorporate clinical lab test results into 
Certified EHR Technology as structured data.
    (ii) Measure. Subject to paragraph (c) of this section, more than 55 
percent of all clinical lab tests results ordered by the EP during the 
EHR reporting period whose results are either in a positive/negative 
affirmation or numerical format are incorporated in Certified EHR 
Technology as structured data.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who orders no lab tests whose results are either in a positive/
negative affirmation or numerical format during the EHR reporting 
period.
    (8)(i) Objective. Generate lists of patients by specific conditions 
to use for quality improvement, reduction of disparities, research, or 
outreach.
    (ii) Measure. Generate at least one report listing patients of the 
EP with a specific condition.
    (9)(i) Objective. Use clinically relevant information to identify 
patients who should receive reminders for preventive/follow-up care and 
send these patients the reminder, per patient preference.
    (ii) Measure. Subject to paragraph (c) of this section, more than 10 
percent of all unique patients who have had two or more office visits 
with the EP within the 24 months before the beginning of the EHR 
reporting period were sent a reminder, per patient preference when 
available.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who has had no office visits in the 24 months before the 
beginning of the EHR reporting period.
    (10)(i) Objective. Provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    (ii) Measures. (A) More than 50 percent of all unique patients seen 
by the EP during the EHR reporting period are provided timely (available 
to the patient within 4 business days after the information is available 
to the EP) online access to their health information subject to the EP's 
discretion to withhold certain information; and
    (B) More than 5 percent of all unique patients seen by the EP during 
the

[[Page 799]]

EHR reporting period (or their authorized representatives) view, 
download or transmit to a third party their health information.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who--
    (A) Neither orders nor creates any of the information listed for 
inclusion as part of the measures in paragraphs (j)(10)(ii)(A) and (B) 
of this section, except for ``Patient name'' and ``Provider's name and 
office contact information,'' is excluded from both paragraphs 
(j)(10)(ii)(A) and (B) of this section; or
    (B) Conducts 50 percent or more of his or her patient encounters in 
a county that does not have 50 percent or more of its housing units with 
3Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period is 
excluded from paragraph (j)(10)(ii)(B) of this section.
    (11)(i) Objective. Provide clinical summaries for patients for each 
office visit.
    (ii) Measure. Subject to paragraph (c) of this section, clinical 
summaries provided to patients or patient-authorized representatives 
within 1 business day for more than 50 percent of office visits.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (12)(i) Objective. Use clinically relevant information from 
Certified EHR Technology to identify patient-specific education 
resources and provide those resources to the patient.
    (ii) Measure. Patient-specific education resources identified by 
Certified EHR Technology are provided to patients for more than 10 
percent of all unique patients with office visits seen by the EP during 
the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (13)(i) Objective. The EP who receives a patient from another 
setting of care or provider of care or believes an encounter is relevant 
should perform medication reconciliation.
    (ii) Measure. Subject to paragraph (c) of this section, the EP 
performs medication reconciliation for more than 50 percent of 
transitions of care in which the patient is transitioned into the care 
of the EP.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who was not the beneficiary of any transitions of care during the 
EHR reporting period.
    (14)(i) Objective. The EP who transitions their patient to another 
setting of care or provider of care or refers their patient to another 
provider of care provides a summary care record for each transition of 
care or referral.
    (ii) Measures. (A) Subject to paragraph (c) of this section, the EP 
that transitions or refers their patient to another setting of care or 
provider of care provides a summary of care record for more than 50 
percent of transitions of care and referrals;
    (B) Subject to paragraph (c) of this section, the EP that 
transitions or refers their patient to another setting of care or 
provider of care provides a summary of care record for more than 10 
percent of such transitions and referrals either--
    (1) Electronically transmitted using Certified EHR Technology to a 
beneficiary; or
    (2) Where the beneficiary receives the summary of care record via 
exchange facilitated by an organization that is a NwHIN Exchange 
participant or in a manner that is consistent with the governance 
mechanism ONC establishes for the nationwide health information network, 
and
    (C) Subject to paragraph (c) of this section an EP must satisfy one 
of the following:
    (1) Conducts one or more successful electronic exchanges of a 
summary of care record meeting the measure specified in paragraph 
(j)(14)(ii)(B) of this section with a beneficiary using technology to 
receive the summary of care record that was designed by a different EHR 
developer than the sender's EHR technology certified at 45 CFR 
170.314(b)(2); or
    (2) Conducts one or more successful tests with the CMS designated 
test EHR during the EHR reporting period.

[[Page 800]]

    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who transfers a patient to another setting or refers a patient to 
another provider less than 100 times during the EHR reporting period.
    (15)(i) Objective. Capability to submit electronic data to 
immunization registries or immunization information systems except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic 
immunization data from Certified EHR Technology to an immunization 
registry or immunization information system for the entire EHR reporting 
period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP that meets one or more of the following criteria:
    (A) Does not administer any of the immunizations to any of the 
populations for which data is collected by their jurisdiction's 
immunization registry or immunization information system during the EHR 
reporting period.
    (B) Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required for Certified EHR Technology at the start of his or 
her EHR reporting period.
    (C) Operates in a jurisdiction where no immunization registry or 
immunization information system provides information timely on 
capability to receive immunization data.
    (D) Operates in a jurisdiction for which no immunization registry or 
immunization information system that is capable of accepting the 
specific standards required by Certified EHR Technology at the start of 
his or her EHR reporting period can enroll additional EPs.
    (16)(i) Objective. Protect electronic health information created or 
maintained by the Certified EHR Technology through the implementation of 
appropriate technical capabilities.
    (ii) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the encryption/security of data stored in Certified EHR 
Technology in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security 
updates as necessary and correct identified security deficiencies as 
part of the EP's risk management process.
    (17)(i) Objective. Use secure electronic messaging to communicate 
with patients on relevant health information.
    (ii) Measure. A secure message was sent using the electronic 
messaging function of Certified EHR Technology by more than 5 percent of 
unique patients (or their authorized representatives) seen by the EP 
during the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who meets one or more of the following criteria:
    (A) Has no office visits during the EHR reporting period.
    (B) Who conducts 50 percent or more of his or her patient encounters 
in a county that does not have 50 percent or more of its housing units 
with 3Mbps broadband availability according to the latest information 
available from the FCC on the first day of their EHR reporting period.
    (k) Stage 2 menu set criteria for EPs. An EP must meet 3 of the 
following objectives and associated measures, unless the EP has an 
exclusion from 4 or more objectives in this paragraph (k) of this 
section, in which case the EP must meet all remaining objectives and 
associated measures.
    (1)(i) Objective. Imaging results consisting of the image itself and 
any explanation or other accompanying information are accessible through 
Certified EHR Technology.
    (ii) Measure. Subject to paragraph (c) of this section, more than 10 
percent of all tests whose result is one or more images ordered by the 
EP during the EHR reporting period are accessible through Certified EHR 
Technology.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who meets one or more of the following criteria.
    (A) Orders less than 100 tests whose result is an image during the 
EHR reporting period.
    (B) Has no access to electronic imaging results at the start of the 
EHR reporting period.

[[Page 801]]

    (2)(i) Objective. Record patient family health history as structured 
data.
    (ii) Measure. More than 20 percent of all unique patients seen by 
the EP during the EHR reporting period have a structured data entry for 
one or more first-degree relatives.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (3)(i) Objective. Capability to submit electronic syndromic 
surveillance data to public health agencies, except where prohibited, 
and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic syndromic 
surveillance data from Certified EHR Technology to a public health 
agency for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP that meets one or more of the following criteria:
    (A) Is not in a category of providers who collect ambulatory 
syndromic surveillance information on their patients during the EHR 
reporting period.
    (B) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required for Certified EHR Technology at the start of 
their EHR reporting period.
    (C) Operates in a jurisdiction where no public health agency 
provides information timely on capability to receive syndromic 
surveillance data.
    (D) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific standards required by 
Certified EHR Technology at the start of their EHR reporting period can 
enroll additional EPs.
    (4)(i) Objective. Capability to identify and report cancer cases to 
a public health central cancer registry, except where prohibited, and in 
accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of cancer case 
information from Certified EHR Technology to a public health central 
cancer registry for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who meets one or more of the following--
    (A) Does not diagnose or directly treat cancer.
    (B) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic cancer case information in the specific 
standards required for Certified EHR Technology at the start of their 
EHR reporting period.
    (C) Operates in a jurisdiction where no public health agency 
provides information timely on capability to receive electronic cancer 
case information.
    (D) Operates in a jurisdiction for which no public health agency 
that is capable of receiving electronic cancer case information in the 
specific standards required for Certified EHR Technology at the 
beginning of their EHR reporting period can enroll additional EPs.
    (5)(i) Objective. Capability to identify and report specific cases 
to a specialized registry (other than a cancer registry), except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of specific case 
information from Certified EHR Technology to a specialized registry for 
the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section. 
Any EP who meets one or more of the following criteria:
    (A) Does not diagnose or directly treat any disease associated with 
a specialized registry sponsored by a national specialty society for 
which the EP is eligible, or the public health agencies in their 
jurisdiction;
    (B) Operates in a jurisdiction for which no specialized registry 
sponsored by a public health agency or by a national specialty society 
for which the EP is eligible is capable of receiving electronic specific 
case information in the specific standards required by Certified EHR 
Technology at the beginning of their EHR reporting period;
    (C) Operates in a jurisdiction where no public health agency or 
national specialty society for which the EP is eligible provides 
information timely on

[[Page 802]]

capability to receive information into their specialized registries; or
    (D) Operates in a jurisdiction for which no specialized registry 
sponsored by a public health agency or by a national specialty society 
for which the EP is eligible that is capable of receiving electronic 
specific case information in the specific standards required by 
Certified EHR Technology at the beginning of his or her EHR reporting 
period can enroll additional EPs.
    (6)(i) Objective. Record electronic notes in patient records.
    (ii) Measure. Enter at least one electronic progress note created, 
edited, and signed by an EP for more than 30 percent of unique patients 
with at least one office visit during the EHR reporting period. The text 
of the electronic note must be text-searchable and may contain drawings 
and other content.
    (l) Stage 2 core criteria for eligible hospitals or CAHs. An 
eligible hospital or CAH must meet the following objectives and 
associated measures except those objectives and associated measures for 
which an eligible hospital or CAH qualifies for an exclusion under 
paragraph (i)(2) of this section.
    (1)(i) Objective. Use computerized provider order entry for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per State, local, and professional guidelines.
    (ii) Measures. Subject to paragraph (c) of this section, more than--
    (A) Sixty percent of medication orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry,
    (B) Thirty percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry, and
    (C) Thirty percent of radiology orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (2)(i) Objective. Record all of the following demographics:
    (A) Preferred language.
    (B) Sex.
    (C) Race.
    (D) Ethnicity.
    (E) Date of birth.
    (F) Date and preliminary cause of death in the event of mortality in 
the eligible hospital or CAH.
    (ii) Measure. More than 80 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) during the EHR reporting period have demographics 
recorded as structured data.
    (3)(i) Objective. Record and chart changes in the following vital 
signs:
    (A) Height/Length.
    (B) Weight.
    (C) Blood pressure (ages 3 and over).
    (D) Calculate and display body mass index (BMI).
    (E) Plot and display growth charts for patients 0-20 years, 
including body mass index.
    (ii) Measure. Subject to paragraph (c) of this section, more than 80 
percent of all unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period have blood pressure (for patients age 3 and over only) 
and height/length and weight (for all ages) recorded as structured data.
    (4)(i) Objective. Record smoking status for patients 13 years old or 
older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 80 
percent of all unique patients 13 years old or older admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period have smoking status recorded as 
structured data.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that admits no patients 13 years old or 
older to their inpatient or emergency department (POS 21 or 23) during 
the EHR reporting period.
    (5)(i) Objective. Use clinical decision support to improve 
performance on high priority health conditions.

[[Page 803]]

    (ii) Measures. (A) Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an eligible hospital or 
CAH's patient population, the clinical decision support interventions 
must be related to high-priority health conditions; and
    (B) The eligible hospital or CAH has enabled and implemented the 
functionality for drug-drug and drug-allergy interaction checks for the 
entire EHR reporting period.
    (6)(i) Objective. Incorporate clinical lab test results into 
Certified EHR Technology as structured data.
    (ii) Measure. Subject to paragraph (c) of this section, more than 55 
percent of all clinical lab tests results ordered by authorized 
providers of the eligible hospital or CAH for patients admitted to its 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period whose results are either in a positive/negative 
affirmation or numerical format are incorporated in Certified EHR 
Technology as structured data.
    (7)(i) Objective. Generate lists of patients by specific conditions 
to use for quality improvement, reduction of disparities, research or 
outreach.
    (ii) Measure. Generate at least one report listing patients of the 
eligible hospital or CAH with a specific condition.
    (8)(i) Objective. Provide patients the ability to view online, 
download, and transmit information about a hospital admission.
    (ii) Measures. (A) More than 50 percent of all unique patients who 
are discharged from the inpatient or emergency department (POS 21 or 23) 
of an eligible hospital or CAH have their information available online 
within 36 hours of discharge; and
    (B) More than 5 percent of all unique patients who are discharged 
from the inpatient or emergency department (POS 21 or 23) of an eligible 
hospital or CAH (or their authorized representative) view, download or 
transmit to a third party their information during the EHR reporting 
period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that is located in a county that does not 
have 50 percent or more of its housing units with 3Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period is excluded from paragraph 
(l)(8)(ii)(B) of this section.
    (9)(i) Objective. Use clinically relevant information from Certified 
EHR Technology to identify patient-specific education resources and 
provide those resources to the patient.
    (ii) Measure. More than 10 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) are provided patient-specific education resources 
identified by Certified EHR Technology.
    (10)(i) Objective. The eligible hospital or CAH that receives a 
patient from another setting of care or provider of care or believes an 
encounter is relevant should perform medication reconciliation.
    (ii) Measure. Subject to paragraph (c) of this section, the eligible 
hospital or CAH performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
    (11)(i) Objective. The eligible hospital or CAH that transitions 
their patient to another setting of care or provider of care or refers 
their patient to another provider of care provides a summary care record 
for each transition of care or referral.
    (ii) Measures. (A) Subject to paragraph (c) in this section, the 
eligible hospital or CAH that transitions or refers their patient to 
another setting of care or provider of care provides a summary of care 
record for more than 50 percent of transitions of care and referrals,
    (B) Subject to paragraph (c) in this section, the eligible hospital 
or CAH that transitions their patient to another setting of care or 
provider of care provides a summary of care record for more than 10 
percent of such transitions and referrals either--
    (1) Electronically transmitted using Certified EHR Technology to a 
beneficiary; or

[[Page 804]]

    (2) Where the beneficiary receives the summary of care record via 
exchange facilitated by an organization that is a NwHIN Exchange 
participant or in a manner that is consistent with the governance 
mechanism ONC establishes for the nationwide health information network; 
and
    (C) Subject to paragraph (c) of this section an eligible hospital or 
CAH must satisfy one of the following:
    (1) Conducts one or more successful electronic exchanges of a 
summary of care record meeting the measure specified in paragraph 
(l)(11)(ii)(B) of this section with a beneficiary using technology to 
receive the summary of care record that was designed by a different EHR 
developer than the sender's EHR technology certified at 45 CFR 
170.314(b)(2); or
    (2) Conducts one or more successful tests with the CMS designated 
test EHR during the EHR reporting period.
    (12)(i) Objective. Capability to submit electronic data to 
immunization registries or immunization information systems except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic 
immunization data from Certified EHR Technology to an immunization 
registry or immunization information system for the entire EHR reporting 
period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that meets one or more of the following 
criteria:
    (A) The eligible hospital or CAH does not administer any of the 
immunizations to any of the populations for which data is collected by 
their jurisdiction's immunization registry or immunization information 
system during the EHR reporting period.
    (B) The eligible hospital or CAH operates in a jurisdiction for 
which no immunization registry or immunization information system is 
capable of accepting the specific standards required for Certified EHR 
Technology at the start of their EHR reporting period.
    (C) The eligible hospital or CAH operates in a jurisdiction where no 
immunization registry or immunization information system provides 
information timely on capability to receive immunization data.
    (D) Operates in a jurisdiction for which no immunization registry or 
immunization information system that is capable of accepting the 
specific standards required by Certified EHR Technology at the start of 
their EHR reporting period can enroll additional eligible hospitals or 
CAHs.
    (13)(i) Objective. Capability to submit electronic reportable 
laboratory results to public health agencies, where except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic reportable 
laboratory results from Certified EHR Technology to a public health 
agency for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that meets one or more of the following 
criteria:
    (A) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic reportable laboratory results in the 
specific standards required for Certified EHR Technology at the start of 
their EHR reporting period.
    (B) Operates in a jurisdiction for which no public health agency 
provides information timely on capability to receive electronic 
reportable laboratory results.
    (C) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific standards required by 
Certified EHR Technology at the start of their EHR reporting period can 
enroll additional eligible hospitals or CAHs.
    (14)(i) Objective. Capability to submit electronic syndromic 
surveillance data to public health agencies, except where prohibited, 
and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic syndromic 
surveillance data from Certified EHR Technology to a public health 
agency for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that meets one or more of the following 
criteria:
    (A) Does not have an emergency or urgent care department.

[[Page 805]]

    (B) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required for Certified EHR Technology at the start of 
their EHR reporting period or can enroll additional eligible hospitals 
or CAHs.
    (C) Operates in a jurisdiction for which no public health agency 
provides information timely on capability to receive syndromic 
surveillance data.
    (D) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific standards required by 
Certified EHR Technology at the start of their EHR reporting period can 
enroll additional eligible hospitals or CAHs.
    (15)(i) Objective. Protect electronic health information created or 
maintained by the Certified EHR Technology through the implementation of 
appropriate technical capabilities.
    (ii) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the encryption/security of data stored in Certified EHR 
Technology in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security 
updates as necessary and correct identified security deficiencies as 
part of the eligible hospital's or CAH's risk management process.
    (16)(i) Objective. Automatically track medications from order to 
administration using assistive technologies in conjunction with an 
electronic medication administration record (eMAR).
    (ii) Measure. Subject to paragraph (c) of this section, more than 10 
percent of medication orders created by authorized providers of the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period for which all doses are tracked 
using eMAR.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH with an average daily inpatient census of 
fewer than 10 patients.
    (m) Stage 2 menu set criteria for eligible hospitals or CAHs. An 
eligible hospital or CAH must meet the measure criteria for three of the 
following objectives and associated measures.
    (1)(i) Objective. Record whether a patient 65 years old or older has 
an advance directive.
    (ii) Measure. Subject to paragraph (c) of this section, more than 50 
percent of all unique patients 65 years old or older admitted to the 
eligible hospital's or CAH's inpatient department (POS 21) during the 
EHR reporting period have an indication of an advance directive status 
recorded as structured data.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that admits no patients age 65 years old or 
older during the EHR reporting period.
    (2)(i) Objective. Imaging results consisting of the image itself and 
any explanation or other accompanying information are accessible through 
Certified EHR Technology.
    (ii) Measure. Subject to paragraph (c) of this section, more than 10 
percent of all tests whose result is an image ordered by an authorized 
provider of the eligible hospital or CAH for patients admitted to its 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are accessible through Certified EHR Technology.
    (3)(i) Objective. Record patient family health history as structured 
data.
    (ii) Measure. More than 20 percent of all unique patients admitted 
to the eligible hospital or CAH's inpatient or emergency department (POS 
21 or 23) during the EHR reporting period have a structured data entry 
for one or more first-degree relatives.
    (4)(i) Objective. Generate and transmit permissible discharge 
prescriptions electronically (eRx).
    (ii) Measure. Subject to paragraph (c) of this section, more than 10 
percent of hospital discharge medication orders for permissible 
prescriptions (for new, changed and refilled prescriptions) are queried 
for a drug formulary and transmitted electronically using Certified EHR 
Technology.
    (iii) Exclusion in accordance with paragraph (i)(2) of this section. 
Any eligible hospital or CAH that does not have an internal pharmacy 
that can accept electronic prescriptions and there are no pharmacies 
that accept electronic

[[Page 806]]

prescriptions within 10 miles at the start of its EHR reporting period.
    (5)(i) Objective. Record electronic notes in patient records.
    (ii) Measure: Enter at least one electronic progress note created, 
edited and signed by an authorized provider of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) for more than 
30 percent of unique patients admitted to the eligible hospital or CAH's 
inpatient or emergency department during the EHR reporting period. The 
text of the electronic note must be text-searchable and may contain 
drawings and other content.
    (6)(i) Objective. Provide structured electronic lab results to 
ambulatory providers.
    (ii) Measures. Hospital labs send structured electronic clinical lab 
results to the ordering provider for more than 20 percent of--
    (A) The electronic lab orders received; or
    (B) The lab orders received.

[75 FR 44565, July 28, 2010, as amended at 75 FR 81887, Dec. 29, 2010; 
77 FR 54149, Sept. 4, 2012; 77 FR 64758, Oct. 23, 2012; 77 FR 72991, 
Dec. 7, 2012; 79 FR 52932, Sept. 4, 2014. Redesignated and amended at 80 
FR 62943, Oct. 16, 2015; 85 FR 59026, Sept. 18, 2020]



Sec. 495.22  Meaningful use objectives and measures for EPs, eligible
hospitals, and CAHs for 2015 through 2018.

    (a) General rules. (1) Subject to the provisions of paragraph (a)(2) 
of this section, the criteria specified in this section are applicable 
for EPs, eligible hospitals, and CAHs for 2015 through 2018.
    (2) For 2017 and 2018, EPs, eligible hospitals, and CAHs that have 
successfully demonstrated meaningful use in a prior year have the option 
to use the criteria specified for 2019 in Sec. 495.24 instead of the 
criteria specified for 2017 and 2018 under paragraphs (e) and (f) of 
this section.
    (b) Criteria for EPs for 2015 through 2018--(1) General rule 
regarding criteria for meaningful use for 2015 through 2018 for EPs. 
Except as specified in paragraph (b)(2) of this section, EPs must meet 
all objectives and associated measures of the meaningful use criteria 
specified under paragraph (e) of this section to meet the definition of 
a meaningful EHR user.
    (2) Exclusion for non-applicable objectives. (i) An EP may exclude a 
particular objective contained in paragraph (e) of this section, if the 
EP meets all of the following requirements:
    (A) Must ensure that the objective in paragraph (e) of this section 
includes an option for the EP to attest that the objective is not 
applicable.
    (B) Meets the criteria in the applicable objective that would permit 
the attestation to the exclusion.
    (C) Attests.
    (ii) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (e) of this section.
    (c) Criteria for eligible hospitals and CAHs for 2015 through 2018--
(1) General rule regarding criteria for meaningful use for 2015 through 
2018 for eligible hospitals and CAHs. Except as specified in paragraph 
(c)(2) of this section, eligible hospitals and CAHs attesting to CMS 
must meet all objectives and associated measures of the meaningful use 
criteria specified under paragraph (e) of this section to meet the 
definition of a meaningful EHR user in 2015 and 2016 and must meet all 
objectives and associated measures of the meaningful use criteria 
specified under paragraph (f) of this section to meet the definition of 
a meaningful EHR user in 2017 and 2018. Except as specified in paragraph 
(c)(2) of this section, eligible hospitals and CAHs attesting to a State 
for the Medicaid EHR Incentive Program must meet all objectives and 
associated measures of the meaningful use criteria specified under 
paragraph (e) of this section to meet the definition of a meaningful EHR 
user in 2015 through 2018.
    (2) Exclusion for non-applicable objectives. (i) An eligible 
hospital or CAH may exclude a particular objective contained in 
paragraph (e) of this section, if the eligible hospital or CAH meets all 
of the following requirements:
    (A) Must ensure that the objective in paragraph (e) of this section 
includes an option for the eligible hospital or CAH to attest that the 
objective is not applicable.

[[Page 807]]

    (B) Meets the criteria in the applicable objective that would permit 
the attestation to the exclusion.
    (C) Attests.
    (ii) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (e) of this section.
    (d) Many of the objectives and associated measures in paragraph (e) 
of this section rely on measures that count unique patients or actions. 
(1) If a measure (or associated objective) in paragraph (e) or (f) of 
this section references this paragraph (d), the measure may be 
calculated by reviewing only the actions for patients whose records are 
maintained using CEHRT. A patient's record is maintained using CEHRT if 
sufficient data were entered in the CEHRT to allow the record to be 
saved, and not rejected due to incomplete data.
    (2) If the objective and associated measure does not reference this 
paragraph (d) of this section, then the measure must be calculated by 
reviewing all patient records, not just those maintained using CEHRT.
    (e) Meaningful use objectives and measures for EPs for 2015 through 
2018, for eligible hospitals and CAHs attesting to CMS for 2015 and 
2016, and for eligible hospitals and CAHs attesting to a State for the 
Medicaid EHR Incentive Program for 2015 through 2018.--(1) Protect 
patient health information--(i) Objective. Protect electronic protected 
health information created or maintained by the CEHRT through the 
implementation of appropriate technical capabilities.
    (ii) Measures--(A) EP measure. Conduct or review a security risk 
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), 
including addressing the security (to include encryption) of ePHI 
created or maintained by CEHRT in accordance with requirements under 45 
CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security 
updates as necessary and correct identified security deficiencies as 
part of the EP's risk management process.
    (B) Eligible hospital or CAH measure. Conduct or review a security 
risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including Addressing the security (to include encryption) 
of ePHI created or maintained in CEHRT in accordance with requirements 
under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement 
security updates as necessary, and correct identified security 
deficiencies as part of the eligible hospital's or CAH's risk management 
process.
    (2) Clinical decision support--(i) Objective. Use clinical decision 
support to improve performance on high-priority health conditions.
    (ii) EP measures--(A) Measure. In order for EPs to meet the 
objective they must satisfy both of the following measures:
    (1) Implement five clinical decision support interventions related 
to four or more clinical quality measures at a relevant point in patient 
care for the entire EHR reporting period. Absent four clinical quality 
measures related to an EP's scope of practice or patient population, the 
clinical decision support interventions must be related to high-priority 
health conditions.
    (2) Enabled and implemented the functionality for drug-drug and 
drug-allergy interaction checks for the entire EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
An EP who writes fewer than 100 medication orders during the EHR 
reporting period may be excluded from the measure under paragraph 
(e)(2)(i)(A)(2) of this section.
    (C) Alternate specifications. An EP previously scheduled to be in 
Stage 1 in 2015 may meet an alternate objective and measure specified in 
paragraph (e)(2)(ii)(C)(1) and (2) in place of the measure outlined 
under paragraph (e)(2)(ii)(A)(1) of this section for an EHR reporting 
period in 2015 only.
    (1) Alternate objective. Implement one clinical decision support 
rule relevant to specialty or high clinical priority along with the 
ability to track compliance with that rule.
    (2) Alternate measure. Implement one clinical decision support rule.
    (iii) Eligible hospital and CAH measures--(A) Measure. In order for 
eligible hospitals and CAHs to meet the objective they must satisfy both 
of the following measures:
    (1) Implement five clinical decision support interventions related 
to four or

[[Page 808]]

more clinical quality measures at a relevant point in patient care for 
the entire EHR reporting period. Absent four clinical quality measures 
related to an eligible hospital or CAH's scope of practice or patient 
population, the clinical decision support interventions must be related 
to high-priority health conditions.
    (2) Enabled and implemented the functionality for drug-drug and 
drug-allergy interaction checks for the entire EHR reporting period.
    (B) Alternate specifications. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may meet an alternate measure 
described in paragraph (e)(2)(iii)(B)(2) of this section in place of the 
measure described in paragraph (e)(2)(iii)(A)(1) of this section for an 
EHR reporting period in 2015.
    (1) Alternate objective. Implement one clinical decision support 
rule relevant to a high priority hospital condition along with the 
ability to track compliance with that rule.
    (2) Alternate measure. Implement one clinical decision support rule.
    (3) Computerized provider order entry--(i) Objective. Use 
computerized provider order entry for medication, laboratory, and 
radiology orders directly entered by any licensed healthcare 
professional who can enter orders into the medical record per state, 
local, and professional guidelines.
    (ii) EP measures--(A) Measures. An EP must meet the following 3 
measures, subject to paragraph (d) of this section:
    (1) More than 60 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry.
    (2) More than 30 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry.
    (3) More than 30 percent of radiology orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
(1) For the measure specified in paragraph (e)(3)(ii)(A)(1) of this 
section, any EP who writes fewer than 100 medication orders during the 
EHR reporting period.
    (2) For the measure specified in paragraph (e)(3)(ii)(A)(2) of this 
section, any EP who writes fewer than 100 laboratory orders during the 
EHR reporting period.
    (3) For the measure specified in paragraph (e)(3)(ii)(A)(3) of this 
section, any EP who writes fewer than 100 radiology orders during the 
EHR reporting period.
    (C) Alternate exclusions and specifications. An EP previously 
scheduled to be in Stage 1 in 2015 may meet an alternate measure 
(e)(3)(ii)(C)(1) in place of the measure outlined under paragraph 
(e)(3)(ii)(A)(1) of this section, and may exclude the measures outlined 
under paragraphs (e)(3)(ii)(A)(2) and (3) of this section for an EHR 
reporting period in 2015. An EP previously scheduled to be in Stage 1 in 
2016 may exclude the measures outlined under paragraphs (e)(3)(ii)(A)(2) 
and (3) of this section for an EHR reporting period in 2016.
    (1) Alternate measure 1 in 2015. Subject to paragraph (d) of this 
section--
    (i) More than 30 percent of all unique patients with at least one 
medication in their medication list seen by the EP during the EHR 
reporting period have at least one medication order entered using CPOE; 
or
    (ii) More than 30 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry.
    (2) Alternate exclusions in 2015. An EP scheduled to be in Stage 1 
in 2015 may exclude the measures specified in paragraphs 
(e)(3)(ii)(A)(2) and (e)(3)(ii)(A)(3) of this section in 2015.
    (3) Alternate exclusions in 2016. An EP scheduled to be in Stage 1 
in 2016 may exclude the measure specified in paragraphs (e)(3)(ii)(A)(2) 
and (e)(3)(ii)(A)(3) of this section in 2016.
    (iii) Eligible hospital and CAH measures. (A) An eligible hospital 
or CAH must meet the following 3 measures, subject to paragraph (d) of 
this section:
    (1) More than 60 percent of medication orders created by authorized 
providers of the eligible hospital's or

[[Page 809]]

CAH's inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using computerized provider order entry.
    (2) More than 30 percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (3) More than 30 percent of radiology orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (B) Alternate exclusions and specifications. (1) An eligible 
hospital or CAH previously scheduled to be in Stage 1 in 2015 may meet 
an alternate measure specified in paragraph (e)(3)(iii)(B)(2) of this 
section in place of the measure outlined under paragraph 
(e)(3)(iii)(A)(1) of this section, and may exclude the measures outlined 
under paragraphs (e)(3)(iii)(A)(2) and (e)(3)(iii)(A)(3) of this section 
for an EHR reporting period in 2015. An eligible hospital or CAH 
previously scheduled to be in Stage 1 in 2016 may exclude the measures 
outlined under paragraphs (e)(3)(iii)(A)(2) and (3) of this section for 
an EHR reporting period in 2016.
    (2) Alternate measure 1 in 2015. Subject to paragraph (d) of this 
section--
    (i) More than 30 percent of all unique patients with at least one 
medication in their medication list admitted to the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) have at least 
one medication order entered using CPOE; or
    (ii) More than 30 percent of medication orders created by the 
authorized providers of the eligible hospital or CAH for patients 
admitted to their inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period are recorded using computerized provider 
order entry.
    (3) Alternate exclusions in 2015 and 2016. An eligible hospital or 
CAH scheduled to be in Stage 1 in 2015 may exclude the following 
measures in 2015 and eligible hospital or CAH scheduled to be in Stage 1 
in 2016 may exclude the following measures in 2016:
    (i) The measure specified in paragraph (e)(3)(iii)(A)(2) of this 
section.
    (ii) The measure specified in paragraph (e)(3)(iii)(A)(3) of this 
section.
    (4) Electronic prescribing--(i) Objective. For EPs, generate and 
transmit permissible prescriptions electronically (eRx); and, for 
eligible hospitals and CAHs, generate, and transmit permissible 
discharge prescriptions electronically (eRx).
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, more than 50 percent of all permissible prescriptions written 
by the EP are queried for a drug formulary and transmitted 
electronically using CEHRT.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who--
    (1) Writes fewer than 100 permissible prescriptions during the EHR 
reporting period; or
    (2) Does not have a pharmacy within his or her organization and 
there are no pharmacies that accept electronic prescriptions within 10 
miles of the EP's practice location at the start of his or her EHR 
reporting period.
    (C) Alternate specification. In 2015 an EP--
    (1) Previously scheduled to be in Stage 1 in 2015 may meet an 
alternate measure under paragraph (e)(4)(ii)(C)(2) of this section in 
place of the measure outlined under paragraph(e)(4)(ii)(A) of this 
section; and
    (2) Subject to paragraph (d) of this section, more than 40 percent 
of all permissible prescriptions written by the EP are transmitted 
electronically using CEHRT.
    (iii) Eligible hospital and CAH measure--(A) Measure. Subject to 
paragraph (d) of this section, more than 10 percent of hospital 
discharge medication orders for permissible prescriptions are queried 
for a drug formulary and transmitted electronically using CEHRT.
    (B) Exclusion in accordance with paragraph (c)(2) of this section. 
Any eligible hospital or CAH that does not have an internal pharmacy 
that can accept electronic prescriptions and is not located within 10 
miles of any pharmacy that accepts electronic prescriptions at

[[Page 810]]

the start of their EHR reporting period.
    (C) Alternate exclusions. (1) An eligible hospital or CAH previously 
scheduled to be in--
    (i) Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015; or
    (ii) Stage 2 in 2015 may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015.
    (2) An eligible hospital or CAH previously scheduled to be in--
    (i) Stage 1 in 2016, may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2016; or
    (ii) Stage 2 in 2016, may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2016.
    (5) Health Information Exchange--(i) Objective. The EP, eligible 
hospital or CAH who transitions a patient to another setting of care or 
provider of care or refers a patient to another provider of care 
provides a summary care record for each transition of care or referral.
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, the EP who transitions or refers his or her patient to another 
setting of care or provider of care must do the following:
    (1) Use CEHRT to create a summary of care record.
    (2) Electronically transmit such summary to a receiving provider for 
more than 10 percent of transitions of care and referrals.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who transfers a patient to another setting or refers a patient to 
another provider less than 100 times during the EHR reporting period.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 1 
in 2015 may exclude the measure specified in paragraph (e)(5)(ii)(A) of 
this section for an EHR reporting period in 2015.
    (iii) Eligible hospital and CAH measure--(A) Measure. Subject to 
paragraph (d) of this section, the eligible hospital or CAH that 
transitions or refers its patient to another setting of care or provider 
of care must do the following:
    (1) Use CEHRT to create a summary of care record.
    (2) Electronically transmit such summary to a receiving provider for 
more than 10 percent of transitions of care and referrals.
    (B) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(5)(iii)(A) of this section for an EHR reporting period in 
2015.
    (6) Patient specific education--(i) Objective. Use clinically 
relevant information from CEHRT to identify patient-specific education 
resources and provide those resources to the patient.
    (ii) EP measure--(A) Measure. Patient-specific education resources 
identified by CEHRT are provided to patients for more than 10 percent of 
all unique patients with office visits seen by the EP during the EHR 
reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 1 
in 2015 may exclude the measure specified in paragraph (e)(6)(ii)(A) of 
this section for an EHR reporting period in 2015.
    (iii) Eligible hospital and CAH measure--(A) Measure. More than 10 
percent of all unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) are provided 
patient-specific education resources identified by CEHRT.
    (B) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(6)(iii)(A) of this section for an EHR reporting period in 
2015.
    (7) Medication reconciliation--(i) Objective. The EP, eligible 
hospital or CAH that receives a patient from another setting of care or 
provider of care or believes an encounter is relevant performs 
medication reconciliation.
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, the EP performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is transitioned into 
the care of the EP.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who

[[Page 811]]

was not the recipient of any transitions of care during the EHR 
reporting period.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 1 
in 2015 may exclude the measure specified in paragraph (e)(7)(ii)(A) of 
this section for an EHR reporting period in 2015.
    (iii) Eligible hospital or CAH measure. An eligible hospital or CAH 
must meet the following measure, subject to paragraph (d) of this 
section:
    (A) Measure. Subject to paragraph (d) of this section, the eligible 
hospital or CAH performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
    (B) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(7)(iii)(A) of this section for an EHR reporting period in 
2015.
    (8) Patient electronic access--(i) EP objective. Provide patients 
the ability to view online, download, and transmit their health 
information within 4 business days of the information being available to 
the EP.
    (A) EP measures. An EP must meet the following 2 measures:
    (1) Measure 1: More than 50 percent of all unique patients seen by 
the EP during the EHR reporting period are provided timely access to 
view online, download and transmit to a third party their health 
information subject to the EP's discretion to withhold certain 
information.
    (2) Measure 2: For an EHR reporting period--
    (i) In 2015 and 2016, at least 1 patient seen by the EP during the 
EHR reporting period (or patient-authorized representative) views, 
downloads or transmits his or her health information to a third party 
during the EHR reporting period.
    (ii) In 2017 and 2018, more than 5 percent of unique patients (or 
patient-authorized representatives) discharged from the inpatient or 
emergency department (POS 21 or POS 23) of an eligible hospital or CAH 
during the EHR reporting period view, download or transmit to a third 
party their health information during the EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section--
(1) Any EP who neither orders nor creates any of the information listed 
for inclusion as part of the measure in paragraph (e)(8)(ii)(A)(1) or 
(2) of this section, except for ``Patient name'' and ``Provider's name 
and office contact information,'' is excluded from paragraphs 
(e)(8)(ii)(A)(1) and (2) of this section.
    (2) Any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the Federal Communications Commission on the 
first day of the EHR reporting period is excluded from paragraph 
(e)(8)(ii)(A)(2) of this section.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 1 
in 2015 may exclude the measure specified in paragraph (e)(8)(ii)(A)(2) 
of this section for an EHR reporting period in 2015.
    (ii) Eligible hospital and CAH objective. Provide patients the 
ability to view online, download, and transmit information within 36 
hours of hospital discharge.
    (A) Eligible hospital and CAH measures. An eligible hospital or CAH 
must meet the following 2 measures:
    (1) Measure 1. More than 50 percent of all unique patients who are 
discharged from the inpatient or emergency department (POS 21 or 23) of 
an eligible hospital or CAH have timely access to view online, download 
and transmit to a third party their health information.
    (2) Measure 2. For an EHR reporting period--
    (i) In 2015 or 2016, at least 1 patient (or patient-authorized 
representative) who is discharged from the inpatient or emergency 
department (POS 21 or 23) of an eligible hospital or CAH during the EHR 
reporting period views, downloads or transmits to a third party his or 
her information during the EHR reporting period; and
    (ii) In 2017 and 2018, more than 5 percent of unique patients (or 
patient-authorized representatives) discharged

[[Page 812]]

from the inpatient or emergency department (POS 21 or POS 23) of an 
eligible hospital or CAH during the EHR reporting period view, download 
or transmit to a third party their health information during the EHR 
reporting period.
    (B) Exclusion applicable under paragraph (c)(2) of this section. Any 
eligible hospital or CAH that is located in a county that does not have 
50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period is excluded from paragraph 
(e)(8)(iii)(A)(2) of this section.
    (C) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(8)(iii)(A)(2) of this section for an EHR reporting period 
in 2015.
    (9) Secure messaging--(i) EP objective. Use secure electronic 
messaging to communicate with patients on relevant health information.
    (ii) EP measure--(A) Measure. For an EHR reporting period--
    (1) In 2015, the capability for patients to send and receive a 
secure electronic message with the EP was fully enabled during the EHR 
reporting period;
    (2) In 2016, for at least 1 patient seen by the EP during the EHR 
reporting period, a secure message was sent using the electronic 
messaging function of CEHRT to the patient (or the patient-authorized 
representative), or in response to a secure message sent by the patient 
(or the patient-authorized representative) during the EHR reporting 
period; and
    (3) In 2017 and 2018, for more than 5 percent of unique patients 
seen by the EP during the EHR reporting period, a secure message was 
sent using the electronic messaging function of CEHRT to the patient (or 
the patient-authorized representative), or in response to a secure 
message sent by the patient (or the patient-authorized representative) 
during the EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
An EP may exclude from the measure if he or she--
    (1) Has no office visits during the EHR reporting period; or
    (2) Conducts 50 percent or more of his or her patient encounters in 
a county that does not have 50 percent or more of its housing units with 
4Mbps broadband availability according to the latest information 
available from the Federal Communications Commission on the first day of 
the EP's EHR reporting period.
    (C) Alternate specification. An EP previously scheduled to be in 
Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(9)(ii)(A) of this section for an EHR reporting period in 2015.
    (10) Public Health Reporting--(i) EP Public Health Reporting--(A) 
Objective. The EP is in active engagement with a public health agency to 
submit electronic public health data from CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(e)(10)(i)(A) of this section, an EP must choose from measures 1 through 
3 (as specified in paragraphs (e)(10)(i)(B)(1) through (3) of this 
section) and must successfully attest to any combination of two 
measures. The EP may attest to measure 3 (as specified in paragraph 
(e)(10)(i)(B)(3) of this section more than one time. These measures may 
be met by any combination in accordance with applicable law and 
practice.
    (1) Immunization registry reporting. The EP is in active engagement 
with a public health agency to submit immunization data.
    (2) Syndromic surveillance reporting. The EP is in active engagement 
with a public health agency to submit syndromic surveillance data.
    (3) Specialized registry reporting. The EP is in active engagement 
to submit data to specialized registry.
    (C) Exclusions in accordance with paragraph (b)(2) of this section. 
(1) Any EP meeting one or more of the following criteria may be excluded 
from the immunization registry reporting measure in paragraph 
(e)(10)(i)(B)(1) of this section if the EP:
    (i) Does not administer any immunizations to any of the populations 
for which data is collected by his or her jurisdiction's immunization 
registry or immunization information system during the EHR reporting 
period.

[[Page 813]]

    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of his or 
her EHR reporting period.
    (iii) Operates in a jurisdiction in which no immunization registry 
or immunization information system has declared readiness to receive 
immunization data from the EP at the start of the EHR reporting period.
    (2) Any EP meeting one or more of the following criteria may be 
excluded from the syndromic surveillance reporting measure described in 
paragraph (e)(10)(i)(B)(2) of the section if the EP:
    (i) Is not in a category of providers from which ambulatory 
syndromic surveillance data is collected by their jurisdiction's 
syndromic surveillance system;
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from EPs in 
the specific standards required to meet the CEHRT definition at the 
start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from EPs at 
the start of the EHR reporting period.
    (3) Any EP who meets one or more of the following criteria may be 
excluded from the specialized registry reporting measure described in 
paragraph (e)(10)(i)(B)(3) of this section if the EP:
    (i) Does not diagnose or treat any disease or condition associated 
with or collect relevant data that is required by a specialized registry 
in their jurisdiction during the EHR reporting period;
    (ii) Operates in a jurisdiction for which no specialized registry is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    (iii) Operates in a jurisdiction where no specialized registry for 
which the EP is eligible has declared readiness to receive electronic 
registry transactions at the beginning of the EHR reporting period.
    (D) Alternate specifications. An EP previously scheduled to be in 
Stage 1 in 2015 may choose from measures 1 through 3 (as specified in 
paragraphs (e)(10)(i)(B)(1) through (3) of this section) and must 
successfully attest to any one measure in accordance with applicable law 
and practice for an EHR reporting period in 2015.
    (ii) Eligible hospital and CAH Public Health and Clinical Data 
Registry reporting objective--(A) Objective. The eligible hospital or 
CAH is in active engagement with a public health agency to submit 
electronic public health data from CEHRT, except where prohibited, and 
in accordance with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(e)(10)(ii)(A) of this section, an eligible hospital or CAH must choose 
from measures 1 through 4 (as described in paragraphs (e)(10)(ii)(B)(1) 
through (4) of this section) and must successfully attest to any 
combination of three measures. These measures may be met by any 
combination, including meeting the measure specified in paragraph 
(e)(10)(ii)(B)(3) of this section multiple times, in accordance with 
applicable law and practice:
    (1) Immunization registry reporting. The eligible hospital or CAH is 
in active engagement with a public health agency to submit immunization.
    (2) Syndromic surveillance reporting. The eligible hospital or CAH 
is in active engagement with a public health agency to submit syndromic 
surveillance data
    (3) Specialized registry reporting. The eligible hospital or CAH is 
in active engagement to submit data to a specialized registry.
    (4) Electronic reportable laboratory result reporting. The eligible 
hospital or CAH is in active engagement with a public health agency to 
submit electronic reportable laboratory results.
    (C) Exclusions in accordance with paragraph (c)(2) of this section. 
(1) Any eligible hospital or CAH meeting one or more of the following 
criteria may be excluded from the immunization registry reporting 
measure specified in paragraph (e)(10)(ii)(B)(1) of this section if the 
eligible hospital or CAH:

[[Page 814]]

    (i) Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data from the eligible hospital or CAH at the start of the 
EHR reporting period.
    (2) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
reporting measure specified in paragraph (e)(10)(ii)(B)(2) of this 
section if the eligible hospital or CAH:
    (i) Does not have an emergency or urgent care department.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from 
eligible hospitals or CAHs in the specific standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs at the start of the EHR reporting period.
    (3) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the specialized registry 
reporting measure described in paragraph (e)(10)(i)(B)(3) of this 
section if the eligible hospital or CAH:
    (i) Does not diagnose or directly treat any disease associated with 
or collect relevant data is required by a specialized registry for which 
the eligible hospital or CAH is eligible in their jurisdiction.
    (ii) Operates in a jurisdiction for which no specialized registry is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    (iii) Operates in a jurisdiction where no specialized registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions at the beginning of the EHR 
reporting period.
    (4) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure specified in paragraph 
(d)(10)(ii)(B)(4) of this section if the eligible hospital or CAH:
    (i) Does not perform or order laboratory tests that are reportable 
in the eligible hospital's or CAH's jurisdiction during the EHR 
reporting period
    (ii) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific ELR standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from eligible hospitals or CAHs at the start of the EHR reporting 
period.
    (D) Alternate specification. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may choose from measures 1 through 4 
(as specified in paragraphs (e)(10)(ii)(B)(1) through (4) of this 
section) and must successfully attest to any 2 measures. These measures 
may be met by any combination, including meeting the measures specified 
in paragraph (e)(10)(ii)(B)(3) of this section multiple times, in 
accordance with applicable law and practice.
    (f) Meaningful use objectives and measures for eligible hospitals 
and CAHs attesting to CMS for 2017 and 2018--(1) Protect patient health 
information--(i) Objective. Protect electronic protected health 
information created or maintained by the CEHRT through the 
implementation of appropriate technical capabilities.
    (ii) Security risk analysis measure. Conduct or review a security 
risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including addressing the security (to include

[[Page 815]]

encryption) of ePHI created or maintained in CEHRT in accordance with 
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), 
and implement security updates as necessary, and correct identified 
security deficiencies as part of the eligible hospital's or CAH's risk 
management process.
    (2)-(3) [Reserved]
    (4) Electronic Prescribing--(i) Objective. Generate and transmit 
permissible discharge prescriptions electronically (eRx).
    (ii) e-Prescribing measure. Subject to the provisions of paragraph 
(d) of this section, more than 10 percent of hospital discharge 
medication orders for permissible prescriptions are queried for a drug 
formulary and transmitted electronically using CEHRT.
    (iii) Exclusion for nonapplicable objectives. Subject to the 
provisions of paragraph (c)(2) of this section, any eligible hospital or 
CAH that does not have an internal pharmacy that can accept electronic 
prescriptions and is not located within 10 miles of any pharmacy that 
accepts electronic prescriptions at the start of their EHR reporting 
period.
    (5) Health Information Exchange--(i) Objective. The eligible 
hospital or CAH who transitions a patient to another setting of care or 
provider of care or refers a patient to another provider of care 
provides a summary care record for each transition of care or referral.
    (ii) Health information exchange measure. Subject to the provisions 
of paragraph (d) of this section, the eligible hospital or CAH that 
transitions or refers their patient to another setting of care or 
provider of care must do the following:
    (A) Use CEHRT to create a summary of care record; and
    (B) Electronically transmit such summary to a receiving provider for 
more than 10 percent of transitions of care and referrals.
    (6) Patient specific education--(i) Objective. Use clinically 
relevant information from CEHRT to identify patient-specific education 
resources and provide those resources to the patient.
    (ii) Patient-specific education measure. More than 10 percent of all 
unique patients admitted to the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) are provided patient specific 
education resources identified by CEHRT.
    (7) Medication reconciliation--(i) Objective. The eligible hospital 
or CAH that receives a patient from another setting of care or provider 
of care or believes an encounter is relevant performs medication 
reconciliation.
    (ii) Medication reconciliation measure. Subject to the provisions of 
paragraph (d) of this section, the eligible hospital or CAH performs 
medication reconciliation for more than 50 percent of transitions of 
care in which the patient is admitted to the eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23).
    (8) Patient electronic access--(i) Objective. Provide patients the 
ability to view online, download, and transmit information within 36 
hours of hospital discharge.
    (ii) Measures. An eligible hospital or CAH must meet the following 
two measures:
    (A) Provide patient access measure. More than 50 percent of all 
unique patients who are discharged from the inpatient or emergency 
department (POS 21 or 23) of an eligible hospital or CAH have timely 
access to view online, download, and transmit to a third party their 
health information.
    (B) View, download or transmit (VDT) measure. At least 1 patient (or 
patient-authorized representative) who is discharged from the inpatient 
or emergency department (POS 21 or 23) of an eligible hospital or CAH 
during the EHR reporting period views, downloads, or transmits to a 
third party his or her information during the EHR reporting period.
    (iii) Exclusion for nonapplicable objectives. Subject to the 
provisions of paragraph (c)(2) of this section, any eligible hospital or 
CAH that is located in a county that does not have 50 percent or more of 
its housing units with 4Mbps broadband availability according to the 
latest information available from the FCC on the first day of the EHR 
reporting period is excluded from paragraph (f)(8)(ii)(B) of this 
section.
    (9) Public health reporting--(i) Objective. The eligible hospital or 
CAH is in active engagement with a public health

[[Page 816]]

agency to submit electronic public health data from CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measures. In order to meet the objective under paragraph 
(f)(9)(i) of this section, an eligible hospital or CAH must choose from 
measures 1 through 4 (as described in paragraphs (f)(9)(ii)(A) through 
(D) of this section).
    (A) Immunization registry reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
immunization data.
    (B) Syndromic surveillance reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
syndromic surveillance data.
    (C) Specialized registry reporting measure. The eligible hospital or 
CAH is in active engagement to submit data to a specialized registry.
    (D) Electronic reportable laboratory result reporting measure. The 
eligible hospital or CAH is in active engagement with a public health 
agency to submit electronic reportable laboratory results.
    (iii) Exclusions for non-applicable objectives. Subject to the 
provisions of paragraph (c)(2) of this section--
    (A) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the immunization measure 
specified in paragraph (f)(9)(ii)(A) of this section if the eligible 
hospital or CAH--
    (1) Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period.
    (2) Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (3) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data from the eligible hospital or CAH at the start of the 
EHR reporting period.
    (B) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
measure specified in paragraph (f)(9)(ii)(B) of this section if the 
eligible hospital or CAH--
    (1) Does not have an emergency or urgent care department.
    (2) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from 
eligible hospitals or CAHs in the specific standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs at the start of the EHR reporting period.
    (C) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the specialized registry measure 
specified in paragraph (f)(9)(ii)(C) of this section if the eligible 
hospital or CAH--
    (1) Does not diagnose or directly treat any disease associated with 
or collect relevant data is required by a specialized registry for which 
the eligible hospital or CAH is eligible in their jurisdiction.
    (2) Operates in a jurisdiction for which no specialized registry is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    (3) Operates in a jurisdiction where no specialized registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions at the beginning of the EHR 
reporting period.
    (D) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure specified in paragraph (f)(9)(ii)(D) 
of this section if the eligible hospital or CAH--
    (1) Does not perform or order laboratory tests that are reportable 
in the eligible hospital's or CAH's jurisdiction during the EHR 
reporting period.

[[Page 817]]

    (2) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific ELR standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from eligible hospitals or CAHs at the start of the EHR reporting 
period.

[80 FR 62943, Oct. 16, 2015, as amended at 81 FR 11449, Mar. 4, 2016; 81 
FR 79882, Nov. 14, 2016; 82 FR 38517, Aug. 14, 2017]



Sec. 495.24  Stage 3 meaningful use objectives and measures for EPs, 
eligible hospitals and CAHs for 2019 and subsequent years.

    The criteria specified in paragraphs (c) and (d) of this section are 
optional for 2017 and 2018 for EPs, eligible hospitals, and CAHs that 
have successfully demonstrated meaningful use in a prior year. The 
criteria specified in paragraph (d) of this section are applicable for 
all EPs for 2019 and subsequent years, and for eligible hospitals and 
CAHs attesting to a State for the Medicaid Promoting Interoperability 
Program for 2019 and subsequent years. The criteria specified in 
paragraph (e) of this section are applicable for eligible hospitals and 
CAHs attesting to CMS for 2019 and subsequent years.
    (a) Stage 3 criteria for EPs--(1) General rule regarding Stage 3 
criteria for meaningful use for EPs. Except as specified in paragraphs 
(a)(2) and (3) of this section, EPs must meet all objectives and 
associated measures of the Stage 3 criteria specified in paragraph (d) 
of this section to meet the definition of a meaningful EHR user.
    (2) Selection of measures for specified objectives in paragraph (d) 
of this section. An EP may meet the criteria for 2 out of the 3 measures 
associated with an objective, rather than meeting the criteria for all 3 
of the measures, if the EP meets all of the following requirements:
    (i) Must ensure that the objective in paragraph (d) of this section 
includes an option to meet 2 out of the 3 associated measures.
    (ii) Meets the threshold for 2 out of the 3 measures for that 
objective.
    (iii) Attests to all 3 of the measures for that objective.
    (3) Exclusion for non-applicable objectives and measures. (i) An EP 
may exclude a particular objective that includes an option for exclusion 
contained in paragraph (d) of this section, if the EP meets all of the 
following requirements:
    (A) Meets the criteria in the applicable objective that would permit 
the exclusion.
    (B) Attests to the exclusion.
    (ii) An EP may exclude a measure within an objective which allows 
for a provider to meet the threshold for 2 of the 3 measures, as 
outlined in paragraph (a)(2) of this section, in the following manner:
    (A)(1) Meets the criteria in the applicable measure or measures that 
would permit the exclusion; and
    (2) Attests to the exclusion or exclusions.
    (B)(1) Meets the threshold; and
    (2) Attests to any remaining measure or measures.
    (4) Exception for Medicaid EPs who adopt, implement or upgrade in 
their first payment year. For Medicaid EPs who adopt, implement, or 
upgrade its CEHRT in their first payment year, the meaningful use 
objectives and associated measures of the Stage 3 criteria specified in 
paragraph (d) of this section apply beginning with the second payment 
year, and do not apply to the first payment year.
    (5) Objectives and associated measures in paragraph (d) of this 
section that rely on measures that count unique patients or actions. (i) 
If a measure (or associated objective) in paragraph (d) of this section 
references paragraph (a)(5) of this section, the measure may be 
calculated by reviewing only the actions for patients whose records are 
maintained using CEHRT. A patient's record is maintained using CEHRT if 
sufficient data were entered in the CEHRT to allow the record to be 
saved, and not rejected due to incomplete data.
    (ii) If the objective and associated measure does not reference 
paragraph (a)(5) of this section, the measure must be calculated by 
reviewing all patient records, not just those maintained using CEHRT.

[[Page 818]]

    (b) Stage 3 criteria for meaningful use for eligible hospitals and 
CAHs--(1) General rule. Except as specified in paragraphs (b)(2) and (3) 
of this section, eligible hospitals and CAHs must meet all objectives 
and associated measures of the Stage 3 criteria specified in paragraphs 
(c) and (d) of this section, as applicable, to meet the definition of a 
meaningful EHR user.
    (2) Selection of measures for specified objectives in paragraphs (c) 
and (d) of this section. An eligible hospital or CAH may meet the 
criteria for 2 out of the 3 measures associated with an objective, 
rather than meeting the criteria for all 3 of the measures, if the 
eligible hospital or CAH meets all of the following requirements:
    (i) Must ensure that the objective in paragraph (c) or (d) of this 
section, as applicable, includes an option to meet 2 out of the 3 
associated measures.
    (ii) Meets the threshold for 2 out of the 3 measures for that 
objective.
    (iii) Attests to all 3 of the measures for that objective.
    (3) Exclusion for nonapplicable objectives and measures. (i) An 
eligible hospital or CAH may exclude a particular objective that 
includes an option for exclusion contained in paragraph (c) or (d) of 
this section, as applicable, if the eligible hospital or CAH meets all 
of the following requirements:
    (A) Meets the criteria in the applicable objective that would permit 
the exclusion.
    (B) Attests to the exclusion.
    (ii) An eligible hospital or CAH may exclude a measure within an 
objective which allows for a provider to meet the threshold for 2 of the 
3 measures, as outlined in paragraph (b)(2) of this section, in the 
following manner:
    (A)(1) Meets the criteria in the applicable measure or measures that 
would permit the exclusion; and
    (2) Attests to the exclusion or exclusions.
    (B)(1) Meets the threshold; and
    (2) Attests to any remaining measure or measures.
    (4) Exception for Medicaid eligible hospitals or CAHs that adopt, 
implement or upgrade in their first payment year. For Medicaid eligible 
hospitals or CAHs that adopt, implement or upgrade CEHRT in their first 
payment year, the meaningful use objectives and associated measures of 
the Stage 3 criteria specified in paragraph (c) or (d) of this section 
apply beginning with the second payment year, and do not apply to the 
first payment year.
    (5) Objectives and associated measures in paragraph (c) or (d) of 
this section that rely on measures that count unique patients or 
actions. (i) If a measure (or associated objective) in paragraph (c) or 
(d) of this section, as applicable, references paragraph (b)(5) of this 
section, the measure may be calculated by reviewing only the actions for 
patients whose records are maintained using CEHRT. A patient's record is 
maintained using CEHRT if sufficient data were entered in the CEHRT to 
allow the record to be saved, and not rejected due to incomplete data.
    (ii) If the objective and associated measure does not reference this 
paragraph (b)(5) of this section, the measure must be calculated by 
reviewing all patient records, not just those maintained using CEHRT.
    (c) Stage 3 objectives and measures for eligible hospitals and CAHs 
attesting to CMS--(1) Protect patient health information--(i) Objective. 
Protect electronic protected health information (ePHI) created or 
maintained by the CEHRT through the implementation of appropriate 
technical, administrative, and physical safeguards.
    (ii) Security risk analysis measure. Conduct or review a security 
risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including addressing the security (including encryption) 
of data created or maintained by CEHRT in accordance with requirements 
under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), implement 
security updates as necessary, and correct identified security 
deficiencies as part of the provider's risk management process.
    (2) Electronic prescribing--(i) Objective. Generate and transmit 
permissible discharge prescriptions electronically (eRx).
    (ii) e-Prescribing measure. Subject to paragraph (b)(5) of this 
section, more than 25 percent of hospital discharge

[[Page 819]]

medication orders for permissible prescriptions (for new and changed 
prescriptions) are queried for a drug formulary and transmitted 
electronically using CEHRT.
    (iii) Exclusions in accordance with paragraph (b)(3) of this 
section. Any eligible hospital or CAH that does not have an internal 
pharmacy that can accept electronic prescriptions and there are no 
pharmacies that accept electronic prescriptions within 10 miles at the 
start of the eligible hospital or CAH's EHR reporting period.
    (3)-(4) [Reserved]
    (5) Patient electronic access to health information--(i) Objective. 
The eligible hospital or CAH provides patients (or patient-authorized 
representative) with timely electronic access to their health 
information and patient-specific education.
    (ii) Measures. Eligible hospitals and CAHs must meet the following 
two measures:
    (A) Provide patient access measure. For more than 50 percent of all 
unique patients discharged from the eligible hospital or CAH inpatient 
or emergency department (POS 21 or 23):
    (1) The patient (or patient-authorized representative) is provided 
timely access to view online, download, and transmit his or her health 
information; and
    (2) The provider ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the API in the provider's CEHRT.
    (B) Patient-specific education measure. The eligible hospital or CAH 
must use clinically relevant information from CEHRT to identify patient-
specific educational resources and provide electronic access to those 
materials to more than 10 percent of unique patients discharged from the 
eligible hospital or CAH inpatient or emergency department (POS 21 or 
23) during the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (b)(3) of this section. 
Any eligible hospital or CAH that is located in a county that does not 
have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period is excluded from the 
measures specified in paragraphs (c)(5)(ii)(A) and (B) of this section.
    (6) Coordination of care through patient engagement--(i) Objective. 
Use CEHRT to engage with patients or their authorized representatives 
about the patient's care.
    (ii) Measures. In accordance with paragraph (b)(2) of this section, 
an eligible hospital or CAH must satisfy 2 of the 3 following measures 
in paragraphs (c)(6)(ii)(A), (B), and (C) of this section, except those 
measures for which an eligible hospital or CAH qualifies for an 
exclusion under paragraph (b)(3) of this section.
    (A) View, download or transmit (VDT) measure. During the EHR 
reporting period, at least one unique patient (or their authorized 
representatives) discharged from the eligible hospital or CAH inpatient 
or emergency department (POS 21 or 23) actively engage with the 
electronic health record made accessible by the provider and one of the 
following:
    (1) View, download or transmit to a third party their health 
information.
    (2) Access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT; or
    (3) A combination of paragraphs (c)(6)(ii)(A)(1) and (2) of this 
section.
    (B) Secure messaging measure. During the EHR reporting period, more 
than 5 percent of all unique patients discharged from the eligible 
hospital or CAH inpatient or emergency department (POS 21 or 23) during 
the EHR reporting period, a secure message was sent using the electronic 
messaging function of CEHRT to the patient (or the patient authorized 
representative), or in response to a secure message sent by the patient 
(or the patient authorized representative).
    (C) Patient generated health data. Patient generated health data or 
data from a non-clinical setting is incorporated into the CEHRT for more 
than 5 percent of unique patients discharged

[[Page 820]]

from the eligible hospital or CAH inpatient or emergency department (POS 
21 or 23) during the EHR reporting period.
    (iii) Exclusions under paragraph (b)(3) of this section. Any 
eligible hospital or CAH operating in a location that does not have 50 
percent or more of its housing units with 4Mbps broadband availability 
according to the latest information available from the FCC on the first 
day of the EHR reporting period may exclude from the measures specified 
in paragraphs (c)(6)(ii)(A) through (C) of this section.
    (7) Health information exchange--(i) Objective. The eligible 
hospital or CAH provides a summary of care record when transitioning or 
referring their patient to another setting of care, receives or 
retrieves a summary of care record upon the receipt of a transition or 
referral or upon the first patient encounter with a new patient, and 
incorporates summary of care information from other providers into their 
EHR using the functions of CEHRT.
    (ii) Measures. In accordance with paragraph (b)(2) of this section, 
a eligible hospital or CAH must attest to all 3 measures, but must meet 
the threshold for 2 of the 3 measures in paragraphs (e)(7)(ii)(A) 
through (C) of this section. Subject to paragraph (b)(5) of this 
section--
    (A) Send a summary of care measure. For more than 10 percent of 
transitions of care and referrals, the eligible hospital or CAH that 
transitions or refers its patient to another setting of care or provider 
of care--
    (1) Creates a summary of care record using CEHRT; and
    (2) Electronically exchanges the summary of care record.
    (B) Request/accept summary of care measure. For more than 10 percent 
of transitions or referrals received and patient encounters in which the 
provider has never before encountered the patient, the eligible hospital 
or CAH incorporates into the patient's EHR an electronic summary of care 
document.
    (C) Clinical information reconciliation measure. For more than 50 
percent of transitions or referrals received and patient encounters in 
which the provider has never before encountered the patient, the 
eligible hospital or CAH performs a clinical information reconciliation. 
The provider must implement clinical information reconciliation for the 
following three clinical information sets:
    (1) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication.
    (2) Medication allergy. Review of the patient's known allergic 
medications.
    (3) Current problem list. Review of the patient's current and active 
diagnoses.
    (iii) Exclusions in accordance with paragraph (b)(3) of this 
section. (A) Any eligible hospital or CAH for whom the total of 
transitions or referrals received and patient encounters in which the 
provider has never before encountered the patient, is fewer than 100 
during the EHR reporting period may be excluded from paragraphs 
(c)(7)(ii)(B) and (C) of this section.
    (B) Any eligible hospital or CAH operating in a location that does 
not have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may be excluded from the 
measures specified in paragraphs (e)(7)(ii)(A) and (B) of this section.
    (8) Public health and clinical data registry reporting--(i) 
Objective. The eligible hospital or CAH is in active engagement with a 
public health agency (PHA) or clinical data registry (CDR) to submit 
electronic public health data in a meaningful way using CEHRT, except 
where prohibited, and in accordance with applicable law and practice.
    (ii) Measures. In order to meet the objective under paragraph 
(c)(8)(i) of this section, an eligible hospital or CAH must choose from 
measures 1 through 6 (as described in paragraphs (c)(8)(ii)(A) through 
(F) of this section) and must successfully attest to any combination of 
three measures. These measures may be met by any combination, including 
meeting the measure specified in paragraphs (c)(8)(ii)(D) and (E) of 
this section multiple times, in accordance with applicable law and 
practice:
    (A) Immunization registry reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
immunization

[[Page 821]]

data and receive immunization forecasts and histories from the public 
health immunization registry/immunization information system (IIS).
    (B) Syndromic surveillance reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
syndromic surveillance data from an urgent care setting.
    (C) Electronic case reporting measure. The eligible hospital or CAH 
is in active engagement with a public health agency to submit case 
reporting of reportable conditions.
    (D) Public health registry reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
data to public health registries.
    (E) Clinical data registry reporting measure. The eligible hospital 
or CAH is in active engagement to submit data to a clinical data 
registry.
    (F) Electronic reportable laboratory result reporting measure. The 
eligible hospital or CAH is in active engagement with a public health 
agency to submit electronic reportable laboratory results.
    (iii) Exclusions in accordance with paragraph (b)(3) of this 
section. (A) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the immunization registry 
reporting measure specified in paragraph (c)(8)(ii)(A) of this section 
if the eligible hospital or CAH--
    (1) Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period.
    (2) Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (3) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data as of 6 months prior to the start of the EHR reporting 
period.
    (B) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
reporting measure specified in paragraph (c)(8)(ii)(B) of this section 
if the eligible hospital or CAH--
    (1) Does not have an emergency or urgent care department.
    (2) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required to meet the CEHRT definition at the start of 
the EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs as of 6 months prior to the start of the EHR reporting 
period.
    (C) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the case reporting measure 
specified in paragraph (e)(8)(ii)(C) of this section if the eligible 
hospital or CAH--
    (1) Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the EHR reporting period.
    (2) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of their 
EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data as of 6 
months prior to the start of the EHR reporting period.
    (D) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the public health registry 
reporting measure specified in paragraph (c)(8)(ii)(D) of this section 
if the eligible hospital or CAH--
    (1) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in its jurisdiction during the 
EHR reporting period.
    (2) Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards

[[Page 822]]

required to meet the CEHRT definition at the start of the EHR reporting 
period.
    (3) Operates in a jurisdiction where no public health registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the EHR reporting period.
    (E) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the clinical data registry 
reporting measure specified in paragraph (c)(8)(ii)(E) of this section 
if the eligible hospital or CAH--
    (1) Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period.
    (2) Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (3) Operates in a jurisdiction where no clinical data registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the EHR reporting period.
    (F) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure specified in paragraph (c)(8)(ii)(F) 
of this section if the eligible hospital or CAH--
    (1) Does not perform or order laboratory tests that are reportable 
in its jurisdiction during the EHR reporting period.
    (2) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific ELR standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from an eligible hospital or CAH as of 6 months prior to the start of 
the EHR reporting period.
    (d) Stage 3 objectives and measures for all EPs for 2019 and 
subsequent years, and for eligible hospitals and CAHs attesting to a 
State for the Medicaid Promoting Interoperability Program for 2019 and 
subsequent years--(1) Protect patient health information--(i) EP protect 
patient health information--(A) Objective. Protect electronic protected 
health information (ePHI) created or maintained by the CEHRT through the 
implementation of appropriate technical, administrative, and physical 
safeguards.
    (B) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the security (including encryption) of data created or 
maintained by CEHRT in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), implement security updates 
as necessary, and correct identified security deficiencies as part of 
the provider's risk management process.
    (ii) Eligible hospital/CAH protect patient health information--(A) 
Objective. Protect electronic protected health information (ePHI) 
created or maintained by the CEHRT through the implementation of 
appropriate technical, administrative, and physical safeguards.
    (B) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the security (including encryption) of data created or 
maintained by CEHRT in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), implement security updates 
as necessary, and correct identified security deficiencies as part of 
the provider's risk management process.
    (2) Electronic Prescribing--(i) EP Electronic Prescribing--(A) 
Objective. Generate and transmit permissible prescriptions 
electronically (eRx).
    (B) Measure. Subject to paragraph (a)(5) of this section, more than 
60 percent of all permissible prescriptions written by the EP are 
queried for a drug formulary and transmitted electronically using CEHRT.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
(1) Any EP who writes fewer than 100 permissible

[[Page 823]]

prescriptions during the EHR reporting period; or
    (2) Any EP who does not have a pharmacy within its organization and 
there are no pharmacies that accept electronic prescriptions within 10 
miles of the EP's practice location at the start of his/her EHR 
reporting period.
    (ii) Eligible hospital/CAH electronic prescribing--(A) Objective. 
Generate and transmit permissible discharge prescriptions electronically 
(eRx).
    (B) Measure. Subject to paragraph (b)(5) of this section, more than 
25 percent of hospital discharge medication orders for permissible 
prescriptions (for new and changed prescriptions) are queried for a drug 
formulary and transmitted electronically using CEHRT.
    (C) Exclusions in accordance with paragraph (b)(3) of this section. 
Any eligible hospital or CAH that does not have an internal pharmacy 
that can accept electronic prescriptions and there are no pharmacies 
that accept electronic prescriptions within 10 miles at the start of the 
eligible hospital or CAH's EHR reporting period.
    (3) Clinical decision support--(i) EP clinical decision support--(A) 
Objective. Implement clinical decision support (CDS) interventions 
focused on improving performance on high-priority health conditions.
    (B) Measures. (1) Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an EP's scope of 
practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions; and
    (2) The EP has enabled and implemented the functionality for drug-
drug and drug-allergy interaction checks for the entire EHR reporting 
period.
    (C) Exclusion in accordance with paragraph (a)(3) of this section 
for paragraph (d)(3)(i)(B)(2) of this section. An EP who writes fewer 
than 100 medication orders during the EHR reporting period.
    (ii) Eligible hospital/CAH clinical decision support--(A) Objective. 
Implement clinical decision support (CDS) interventions focused on 
improving performance on high-priority health conditions.
    (B) Measures. (1) Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an eligible hospital or 
CAH's patient population, the clinical decision support interventions 
must be related to high-priority health conditions; and
    (2) The eligible hospital or CAH has enabled and implemented the 
functionality for drug-drug and drug-allergy interaction checks for the 
entire EHR reporting period.
    (4) Computerized provider order entry (CPOE)--(i) EP CPOE--(A) 
Objective. Use computerized provider order entry (CPOE) for medication, 
laboratory, and diagnostic imaging orders directly entered by any 
licensed healthcare professional, credentialed medical assistant, or a 
medical staff member credentialed to and performing the equivalent 
duties of a credentialed medical assistant, who can enter orders into 
the medical record per state, local, and professional guidelines.
    (B) Measures. Subject to paragraph (a)(5) of this section--
    (1) More than 60 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry;
    (2) More than 60 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized provider 
order entry; and
    (3) More than 60 percent of diagnostic imaging orders created by the 
EP during the EHR reporting period are recorded using computerized 
provider order entry.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
(1) For the measure specified in paragraph (d)(4)(i)(B)(1) of this 
section, any EP who writes fewer than 100 medication orders during the 
EHR reporting period.
    (2) For the measure specified in paragraph (d)(4)(i)(B)(2) of this 
section, any

[[Page 824]]

EP who writes fewer than 100 laboratory orders during the EHR reporting 
period.
    (3) For the measure specified in paragraph (d)(4)(i)(B)(3) of this 
section, any EP who writes fewer than 100 diagnostic imaging orders 
during the EHR reporting period.
    (ii) Eligible hospital and CAH CPOE--(A) Objective. Use computerized 
provider order entry (CPOE) for medication, laboratory, and diagnostic 
imaging orders directly entered by any licensed healthcare professional, 
credentialed medical assistant, or a medical staff member credentialed 
to and performing the equivalent duties of a credentialed medical 
assistant; who can enter orders into the medical record per State, 
local, and professional guidelines.
    (B) Measures. Subject to paragraph (b)(5) of this section--
    (1) More than 60 percent of medication orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry;
    (2) More than 60 percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry; and
    (3) More than 60 percent of diagnostic imaging orders created by 
authorized providers of the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period are 
recorded using computerized provider order entry.
    (5) Patient electronic access to health information--(i) EP patient 
electronic access to health information--(A) Objective. The EP provides 
patients (or patient-authorized representative) with timely electronic 
access to their health information and patient-specific education.
    (B) Measures. EPs must meet the following two measures:
    (1) For more than 80 percent of all unique patients seen by the EP--
    (i) The patient (or the patient-authorized representative) is 
provided timely access to view online, download, and transmit his or her 
health information; and
    (ii) The provider ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the API in the provider's CEHRT.
    (2) The EP must use clinically relevant information from CEHRT to 
identify patient-specific educational resources and provide electronic 
access to those materials to more than 35 percent of unique patients 
seen by the EP during the EHR reporting period.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
(1) Any EP who has no office visits during the reporting period may 
exclude from the measures specified in paragraphs (d)(5)(i)(B)(1) and 
(2) of this section.
    (2) Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR reporting 
period may exclude from the measures specified in paragraphs 
(d)(5)(i)(B)(1) and (2) of this section.
    (ii) Eligible hospital and CAH patient electronic access to health 
information--(A) Objective. The eligible hospital or CAH provides 
patients (or patient-authorized representative) with timely electronic 
access to their health information and patient-specific education.
    (B) Measures. Eligible hospitals and CAHs must meet the following 
two measures:
    (1) For more than 80 percent of all unique patients discharged from 
the eligible hospital or CAH inpatient or emergency department (POS 21 
or 23):
    (i) The patient (or patient-authorized representative) is provided 
timely access to view online, download, and transmit his or her health 
information; and
    (ii) The provider ensures the patient's health information is 
available for the

[[Page 825]]

patient (or patient-authorized representative) to access using any 
application of their choice that is configured to meet the technical 
specifications of the API in the provider's CEHRT.
    (2) The eligible hospital or CAH must use clinically relevant 
information from CEHRT to identify patient-specific educational 
resources and provide electronic access to those materials to more than 
35 percent of unique patients discharged from the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    (C) Exclusion in accordance with paragraph (b)(3) of this section. 
Any eligible hospital or CAH that is located in a county that does not 
have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period is excluded from the 
measures specified in paragraphs (d)(5)(ii)(B)(1) and (2) of this 
section.
    (6) Coordination of care through patient engagement--(i) EP 
coordination of care through patient engagement--(A) Objective. Use 
CEHRT to engage with patients or their authorized representatives about 
the patient's care.
    (B) Measures. In accordance with paragraph (a)(2) of this section, 
an EP must satisfy 2 out of the 3 following measures in paragraphs 
(d)(6)(i)(B)(1) through (3) of this section except those measures for 
which an EP qualifies for an exclusion under paragraph (a)(3) of this 
section.
    (1) During the EHR reporting period, more than 5 percent of all 
unique patients (or their authorized representatives) seen by the EP 
actively engage with the electronic health record made accessible by the 
provider and do either of the following:
    (i) View, download or transmit to a third party their health 
information;
    (ii) Access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT; or
    (iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii) of 
this section.
    (2) A secure message was sent using the electronic messaging 
function of CEHRT to the patient (or their authorized representatives), 
or in response to a secure message sent by the patient, for more than 5 
percent of all unique patients seen by the EP during the EHR reporting 
period.
    (3) Patient generated health data or data from a nonclinical setting 
is incorporated into the CEHRT for more than 5 percent of all unique 
patients seen by the EP during the EHR reporting period.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
(1) Any EP who has no office visits during the reporting period may 
exclude from the measures specified in paragraphs (d)(6)(i)(B)(1) 
through (3) of this section.
    (2) Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR reporting 
period may exclude from the measures specified in paragraphs 
(d)(6)(i)(B)(1) through (3) of this section.
    (ii) Eligible hospital and CAH coordination of care through patient 
engagement--(A) Objective. Use CEHRT to engage with patients or their 
authorized representatives about the patient's care.
    (B) Measures. In accordance with paragraph (b)(2) of this section, 
an eligible hospital or CAH must satisfy 2 of the 3 following measures 
in paragraphs (d)(6)(ii)(B)(1) through (3) of this section, except those 
measures for which an eligible hospital or CAH qualifies for an 
exclusion under paragraph (b)(3) of this section.
    (1) During the EHR reporting period, more than 10 percent of all 
unique patients (or their authorized representatives) discharged from 
the eligible hospital or CAH inpatient or emergency department (POS 21 
or 23) actively engage with the electronic health record made accessible 
by the provider and one of the following:
    (i) View, download or transmit to a third party their health 
information.
    (ii) Access their health information through the use of an API that 
can be

[[Page 826]]

used by applications chosen by the patient and configured to the API in 
the provider's CEHRT.
    (iii) A combination of paragraphs (d)(6)(ii)(B)(1)(i) and (ii) of 
this section.
    (iv) For an EHR reporting period in 2017 and 2018, an eligible 
hospital or CAH may meet a threshold of 5 percent instead of 10 percent 
for the measure at paragraph (d)(6)(ii)(B)(1) of this section.
    (2) During the EHR reporting period--
    (i) For an EHR reporting period in 2017 and 2018, for more than 5 
percent of all unique patients discharged from the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period, a secure message was sent using the electronic 
messaging function of CEHRT to the patient (or their authorized 
representatives), or in response to a secure message sent by the patient 
(or their authorized representatives).
    (ii) For an EHR reporting period other than 2017 and 2018, for more 
than 25 percent of all unique patients discharged from the eligible 
hospital or CAH inpatient or emergency department (POS 21 or 23) during 
the EHR reporting period, a secure message was sent using the electronic 
messaging function of CEHRT to the patient (or their authorized 
representatives), or in response to a secure message sent by the patient 
(or their authorized representatives).
    (3) Patient generated health data or data from a non-clinical 
setting is incorporated into the CEHRT for more than 5 percent of unique 
patients discharged from the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    (C) Exclusions under paragraph (b)(3) of this section. Any eligible 
hospital or CAH operating in a location that does not have 50 percent or 
more of its housing units with 4Mbps broadband availability according to 
the latest information available from the FCC on the first day of the 
EHR reporting period may exclude from the measures specified in 
paragraphs (d)(6)(ii)(B)(1) through (3) of this section.
    (7) Health information exchange--(i) EP health information 
exchange--(A) Objective. The EP provides a summary of care record when 
transitioning or referring their patient to another setting of care, 
receives or retrieves a summary of care record upon the receipt of a 
transition or referral or upon the first patient encounter with a new 
patient, and incorporates summary of care information from other 
providers into their EHR using the functions of CEHRT.
    (B) Measures. In accordance with paragraph (a)(2) of this section, 
an EP must attest to all 3 measures, but must meet the threshold for 2 
of the 3 measures in paragraphs (d)(7)(i)(B)(1) through (3) of this 
section, in order to meet the objective. Subject to paragraph (c) of 
this section--
    (1) Measure 1. For more than 50 percent of transitions of care and 
referrals, the EP that transitions or refers their patient to another 
setting of care or provider of care--
    (i) Creates a summary of care record using CEHRT; and
    (ii) Electronically exchanges the summary of care record.
    (2) Measure 2. For more than 40 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the EP incorporates into the patient's EHR an 
electronic summary of care document.
    (3) Measure 3. For more than 80 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the EP performs clinical information 
reconciliation. The EP must implement clinical information 
reconciliation for the following three clinical information sets:
    (i) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication.
    (ii) Medication allergy. Review of the patient's known allergic 
medications.
    (iii) Current problem list. Review of the patient's current and 
active diagnoses.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
An EP must be excluded when any of the following occur:
    (1) Any EP who transfers a patient to another setting or refers a 
patient to another provider less than 100 times

[[Page 827]]

during the EHR reporting period must be excluded from paragraph 
(d)(7)(i)(B)(1) of this section.
    (2) Any EP for whom the total of transitions or referrals received 
and patient encounters in which the provider has never before 
encountered the patient, is fewer than 100 during the EHR reporting 
period may be excluded from paragraphs (d)(7)(i)(B)(2) and (3) of this 
section.
    (3) Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR reporting 
period may exclude from the measures specified in paragraphs 
(d)(7)(i)(B)(1) and (2) of this section.
    (ii) Eligible hospitals and CAHs health information exchange--(A) 
Objective. The eligible hospital or CAH provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the receipt 
of a transition or referral or upon the first patient encounter with a 
new patient, and incorporates summary of care information from other 
providers into their EHR using the functions of CEHRT.
    (B) Measures. In accordance with paragraph (b)(2) of this section, 
an eligible hospital or CAH must attest to all three measures, but must 
meet the threshold for 2 of the 3 measures in paragraphs 
(d)(7)(ii)(B)(1) through (3) of this section. Subject to paragraph 
(b)(5) of this section--
    (1) Measure 1. For more than 50 percent of transitions of care and 
referrals, the eligible hospital or CAH that transitions or refers its 
patient to another setting of care or provider of care--
    (i) Creates a summary of care record using CEHRT; and
    (ii) Electronically exchanges the summary of care record.
    (2) Measure 2. For more than 40 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the eligible hospital or CAH incorporates into 
the patient's EHR an electronic summary of care document from a source 
other than the provider's EHR system.
    (3) Measure 3. For more than 80 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the eligible hospital or CAH performs a 
clinical information reconciliation. The provider must implement 
clinical information reconciliation for the following three clinical 
information sets:
    (i) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication.
    (ii) Medication allergy. Review of the patient's known allergic 
medications.
    (iii) Current problem list. Review of the patient's current and 
active diagnoses.
    (C) Exclusions in accordance with paragraph (b)(3) of this section. 
(1) Any eligible hospital or CAH for whom the total of transitions or 
referrals received and patient encounters in which the provider has 
never before encountered the patient, is fewer than 100 during the EHR 
reporting period may be excluded from paragraphs (d)(7)(i)(B)(2) and (3) 
of this section.
    (2) Any eligible hospital or CAH operating in a location that does 
not have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude from the 
measures specified in paragraphs (d)(7)(ii)(B)(1) and (2) of this 
section.
    (8) Public Health and Clinical Data Registry Reporting--(i) EP 
Public Health and Clinical Data Registry: Reporting objective--(A) 
Objective. The EP is in active engagement with a public health agency or 
clinical data registry to submit electronic public health data in a 
meaningful way using CEHRT, except where prohibited, and in accordance 
with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(d)(8)(i)(A) of this section, an EP must choose from measures 1 through 
5 (paragraphs (d)(8)(i)(B)(1) through (5) of this section) and must 
successfully attest to any combination of two measures. These measures 
may be met by any

[[Page 828]]

combination, including meeting measure specified in paragraph 
(d)(8)(i)(B)(4) or (5) of this section multiple times, in accordance 
with applicable law and practice:
    (1) Immunization registry reporting. The EP is in active engagement 
with a public health agency to submit immunization data and receive 
immunization forecasts and histories from the public health immunization 
registry/immunization information system (IIS).
    (2) Syndromic surveillance reporting. The EP is in active engagement 
with a public health agency to submit syndromic surveillance data from 
an urgent care setting, or from any other setting from which ambulatory 
syndromic surveillance data are collected by the state or a local public 
health agency.
    (3) Electronic case reporting. The EP is in active engagement with a 
public health agency to submit case reporting of reportable conditions.
    (4) Public health registry reporting. The EP is in active engagement 
with a public health agency to submit data to public health registries.
    (5) Clinical data registry reporting. The EP is in active engagement 
to submit data to a clinical data registry.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
(1) Any EP meeting one or more of the following criteria may be excluded 
from the immunization registry reporting measure in paragraph 
(d)(8)(i)(B)(1) of this section if the EP--
    (i) Does not administer any immunizations to any of the populations 
for which data is collected by their jurisdiction's immunization 
registry or immunization information system during the EHR reporting 
period.
    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of its EHR 
reporting period.
    (iii) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data as of 6 months prior to the start of the EHR reporting 
period.
    (2) Any EP meeting one or more of the following criteria may be 
excluded from the syndromic surveillance reporting measure described in 
paragraph (d)(8)(i)(B)(2) of the section if the EP--
    (i) Is not in a category of providers from which ambulatory 
syndromic surveillance data is collected by their jurisdiction's 
syndromic surveillance system.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required to meet the CEHRT definition at the start of 
the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from EPs as of 
6 months prior to the start of the EHR reporting period.
    (3) Any EP meeting one or more of the following criteria may be 
excluded from the case reporting measure at paragraph (d)(8)(i)(B)(3) of 
this section if the EP:
    (i) Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data as of 6 
months prior to the start of the EHR reporting period.
    (4) Any EP meeting at least one of the following criteria may be 
excluded from the public health registry reporting measure specified in 
paragraph (d)(8)(i)(B)(4) of this section if the EP--
    (i) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in the EP's jurisdiction during 
the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards

[[Page 829]]

required to meet the CEHRT definition at the start of the EHR reporting 
period.
    (iii) Operates in a jurisdiction where no public health registry for 
which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions as of 6 months 
prior to the start of the EHR reporting period.
    (5) Any EP meeting at least one of the following criteria may be 
excluded from the clinical data registry reporting measure specified in 
paragraph (d)(8)(i)(B)(5) of this section if the EP--
    (i) Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period.
    (ii) Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no clinical data registry for 
which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions as of 6 months 
prior to the start of the EHR reporting period.
    (ii) Eligible hospital and CAH Public Health and Clinical Data 
Registry: Reporting objective--(A) Objective. The eligible hospital or 
CAH is in active engagement with a public health agency (PHA) or 
clinical data registry (CDR) to submit electronic public health data in 
a meaningful way using CEHRT, except where prohibited, and in accordance 
with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(d)(8)(ii)(A) of this section, an eligible hospital or CAH must choose 
from measures 1 through 6 (as described in paragraphs (d)(8)(ii)(B)(1) 
through (6) of this section) and must successfully attest to any 
combination of four measures. These measures may be met by any 
combination, including meeting the measure specified in paragraph 
(d)(8)(ii)(B)(4) or (5) of this section multiple times, in accordance 
with applicable law and practice:
    (1) Immunization registry reporting. The eligible hospital or CAH is 
in active engagement with a public health agency to submit immunization 
data and receive immunization forecasts and histories from the public 
health immunization registry/immunization information system (IIS).
    (2) Syndromic surveillance reporting. The eligible hospital or CAH 
is in active engagement with a public health agency to submit syndromic 
surveillance data from an urgent care setting.
    (3) Case reporting. The eligible hospital or CAH is in active 
engagement with a public health agency to submit case reporting of 
reportable conditions.
    (4) Public health registry reporting. The eligible hospital or CAH 
is in active engagement with a public health agency to submit data to 
public health registries.
    (5) Clinical data registry reporting. The eligible hospital or CAH 
is in active engagement to submit data to a clinical data registry.
    (6) Electronic reportable laboratory result reporting. The eligible 
hospital or CAH is in active engagement with a public health agency to 
submit electronic reportable laboratory results.
    (C) Exclusions in accordance with paragraph (b)(3) of this section. 
(1) Any eligible hospital or CAH meeting one or more of the following 
criteria may be excluded from to the immunization registry reporting 
measure specified in paragraph (d)(8)(ii)(B)(1) of this section if the 
eligible hospital or CAH--
    (i) Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data as of 6 months prior to the start of the EHR reporting 
period.

[[Page 830]]

    (2) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
reporting measure specified in paragraph (d)(8)(ii)(B)(2) of this 
section if the eligible hospital or CAH--
    (i) Does not have an emergency or urgent care department.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required to meet the CEHRT definition at the start of 
the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs as of 6 months prior to the start of the EHR reporting 
period.
    (3) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the case reporting measure 
specified in paragraph (d)(8)(ii)(B)(3) of this section if the eligible 
hospital or CAH--
    (i) Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of their 
EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data as of 6 
months prior to the start of the EHR reporting period.
    (4) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the public health registry 
reporting measure specified in paragraph (d)(8)(ii)(B)(4) of this 
section if the eligible hospital or CAH--
    (i) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in its jurisdiction during the 
EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no public health registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the EHR reporting period.
    (5) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the clinical data registry 
reporting measure specified in paragraph (d)(8)(ii)(B)(5) of this 
section if the eligible hospital or CAH--
    (i) Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period.
    (ii) Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no clinical data registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the EHR reporting period.
    (6) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure specified in paragraph 
(d)(8)(ii)(B)(6) of this section if the eligible hospital or CAH--
    (i) Does not perform or order laboratory tests that are reportable 
in its jurisdiction during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific ELR standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from an eligible

[[Page 831]]

hospital or CAH as of 6 months prior to the start of the EHR reporting 
period.
    (e) Stage 3 objectives and measures for eligible hospitals and CAHs 
attesting to CMS for 2019 and subsequent years--(1) General rule. (i) 
Except as specified in paragraph (e)(2) of this section, eligible 
hospitals and CAHs must do all of the following as part of meeting the 
definition of a meaningful EHR user under Sec. 495.4:
    (A) Meet all objectives and associated measures of the Stage 3 
criteria specified in this paragraph (e).
    (B) In 2019, 2020, and 2021, earn a total score of at least 50 
points.
    (C) In 2022 and subsequent years, earn a total score of at least 60 
points.
    (ii) Beginning in CY 2020, the numerator and denominator of measures 
increment based on actions occurring during the EHR reporting period 
selected by the eligible hospital or CAH, unless otherwise indicated.
    (2) Exclusion for nonapplicable measures. (i) An eligible hospital 
or CAH may exclude a particular measure that includes an option for 
exclusion contained in this paragraph (e) if the eligible hospital or 
CAH meets the following requirements:
    (A) Meets the criteria in the applicable measure that would permit 
the exclusion.
    (B) Attests to the exclusion.
    (ii) Distribution of points for nonapplicable measures. For eligible 
hospitals or CAHs that claim such exclusion, the points assigned to the 
excluded measure will be distributed to other measures as outlined in 
this paragraph (e).
    (3) Objectives and associated measures in this paragraph (e) that 
rely on measures that count unique patients or actions. (i) If a measure 
(or associated objective) in this paragraph (e) references paragraph 
(e)(3) of this section, the measure may be calculated by reviewing only 
the actions for patients whose records are maintained using CEHRT. A 
patient's record is maintained using CEHRT if sufficient data were 
entered in the CEHRT to allow the record to be saved, and not rejected 
due to incomplete data.
    (ii) If the objective and associated measure does not reference this 
paragraph (e)(3), the measure must be calculated by reviewing all 
patient records, not just those maintained using CEHRT.
    (4) Protect patient health information--(i) Objective. Protect 
electronic protected health information (ePHI) created or maintained by 
the CEHRT through the implementation of appropriate technical, 
administrative, and physical safeguards.
    (ii) Measure scoring. Eligible hospitals and CAHs are required to 
report on the security risk analysis measure in paragraph (e)(4)(iii) of 
this section, but no points are available for this measure. In 2022 and 
subsequent years, eligible hospitals and CAHs are required to report on 
the SAFER Guides measure in paragraph (e)(4)(iv) of this section, but no 
points are available for this measure.
    (iii) Security risk analysis measure. Conduct or review a security 
risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including addressing the security (including encryption) 
of data created or maintained by CEHRT in accordance with requirements 
under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), implement 
security updates as necessary, and correct identified security 
deficiencies as part of the provider's risk management process. Actions 
included in the security risk analysis measure may occur any time during 
the calendar year in which the EHR reporting period occurs.
    (iv) SAFER Guides measure. Conduct an annual self- assessment using 
all nine SAFER Guides at any point during the calendar year in which the 
EHR reporting period occurs.
    (5) Electronic prescribing--(i) Objective. Generate and transmit 
permissible discharge prescriptions electronically (eRx).
    (ii) Measures scoring. (A) In 2019, eligible hospitals and CAHs must 
meet the e-Prescribing measure in paragraph (e)(5)(iii)(A) of this 
section and have the option to report on the query of PDMP measure and 
verify opioid treatment agreement measure in paragraphs (e)(5)(iii)(B) 
and (C) of this section. The electronic prescribing objective in 
paragraph (e)(5)(i) of this section is worth up to 20 points.

[[Page 832]]

    (B) In 2020 and subsequent years, eligible hospitals and CAHs must 
meet the e-Prescribing measure in paragraph (e)(5)(iii)(A) of this 
section, and have the option to report on the query of PDMP measure in 
paragraph (e)(5)(iii)(B) of this section.
    (1) In 2020 and 2021, the electronic prescribing objective in 
paragraph (e)(5)(i) of this section is worth up to 15 points.
    (2) In 2022, the electronic prescribing objective in paragraph 
(e)(5)(i) of this section is worth up to 20 points.
    (iii) Measures--(A) e-Prescribing measure. Subject to paragraph 
(e)(3) of this section, at least one hospital discharge medication order 
for permissible prescriptions (for new and changed prescriptions) is 
queried for a drug formulary and transmitted electronically using CEHRT. 
This measure is worth up to 10 points in CY 2019 and subsequent years.
    (B) Query of prescription drug monitoring program (PDMP) measure. 
Subject to paragraph (e)(3) of this section, for at least one Schedule 
II opioid electronically prescribed using CEHRT during the EHR reporting 
period, the eligible hospital or CAH uses data from CEHRT to conduct a 
query of a Prescription Drug Monitoring Program (PDMP) for prescription 
drug history, except where prohibited and in accordance with applicable 
law. This measure is worth--
    (1) 5 bonus points in CYs 2019, 2020, and 2021; and
    (2) 10 bonus points in CY 2022.
    (C) Verify opioid treatment agreement measure. Subject to paragraph 
(e)(3) of this section, for at least one unique patient for whom a 
Schedule II opioid was electronically prescribed by the eligible 
hospital or CAH using CEHRT during the EHR reporting period, if the 
total duration of the patient's Schedule II opioid prescriptions is at 
least 30 cumulative days within a 6-month look-back period, the eligible 
hospital or CAH seeks to identify the existence of a signed opioid 
treatment agreement and incorporates it into the patient's electronic 
health record using CEHRT. This measure is worth 5 bonus points in CY 
2019.
    (iv) Exclusions in accordance with paragraph (e)(2) of this section 
and redistribution of points. An exclusion claimed under paragraph 
(e)(5)(v) of this section will redistribute 10 points in CY 2019 and CY 
2020 equally among the measures associated with the health information 
exchange objective under paragraph (e)(6) of this section.
    (v) Exclusion in accordance with paragraph (e)(2) of this section. 
Beginning with the EHR reporting period in CY 2019, any eligible 
hospital or CAH that does not have an internal pharmacy that can accept 
electronic prescriptions and there are no pharmacies that accept 
electronic prescriptions within 10 miles at the start of the eligible 
hospital or CAH's EHR reporting period may be excluded from the measure 
specified in paragraph (e)(5)(iii)(A) of this section.
    (6) Health information exchange--(i) Objective. The eligible 
hospital or CAH provides a summary of care record when transitioning or 
referring their patient to another setting of care, receives or 
retrieves a summary of care record upon the receipt of a transition or 
referral or upon the first patient encounter with a new patient, and 
incorporates summary of care information from other providers into their 
EHR using the functions of CEHRT.
    (ii) Measures. For CYs 2019, 2020, and 2021, eligible hospitals and 
CAHs must meet both of the measures specified in paragraphs 
(e)(6)(ii)(A) and (B) of this section (each worth up to 20 points). For 
CY 2022, eligible hospitals and CAHs either must meet both of the 
measures specified in paragraphs (e)(6)(ii)(A) and (B) of this section 
(each worth up to 20 points) or must meet the measure specified in 
paragraph (e)(6)(ii)(C) of this section (worth 40 points).
    (A) Support electronic referral loops by sending health information 
measure: Subject to paragraph (e)(3) of this section, for at least one 
transition of care or referral, the eligible hospital or CAH that 
transitions or refers its patient to another setting of care or provider 
of care--
    (1) Creates a summary of care record using CEHRT; and
    (2) Electronically exchanges the summary of care record.

[[Page 833]]

    (B) Support electronic referral loops by receiving and reconciling 
health information measure. Subject to paragraph (e)(3) of this section, 
for at least one electronic summary of care record received using CEHRT 
for patient encounters during the EHR reporting period for which an 
eligible hospital or CAH was the receiving party of a transition of care 
or referral, or for patient encounters during the EHR reporting period 
in which the eligible hospital or CAH has never before encountered the 
patient, the eligible hospital or CAH conducts clinical information 
reconciliation for medication, medication allergy, and current problem 
list using CEHRT.
    (C) Health information exchange (HIE) bi-directional exchange 
measure. Subject to paragraph (e)(3) of this section, the eligible 
hospital or CAH must attest to the following:
    (1) Participating in an HIE in order to enable secure, bi-
directional exchange of information to occur for all unique patients 
discharged from the eligible hospital or CAH inpatient or emergency 
department (POS 21 or 23), and all unique patient records stored or 
maintained in the EHR for these departments, during the EHR reporting 
period in accordance with applicable law and policy.
    (2) Participating in an HIE that is capable of exchanging 
information across a broad network of unaffiliated exchange partners 
including those using disparate EHRs, and not engaging in exclusionary 
behavior when determining exchange partners.
    (3) Using the functions of CEHRT to support bi-directional exchange 
with an HIE.
    (iii) Exclusions in accordance with paragraph (e)(2) of this 
section. Any eligible hospital or CAH that is unable to implement the 
support electronic referral loops by receiving and incorporating health 
information measure under paragraph (e)(6)(ii)(B) of this section for an 
EHR reporting period in 2019 may be excluded from that measure. Claiming 
the exclusion will redistribute 20 points to the support electronic 
referral loops by sending health information measure under paragraph 
(e)(6)(ii)(A) of this section.
    (7) Provider to patient exchange.--(i) Objective. The eligible 
hospital or CAH provides patients (or patient-authorized representative) 
with timely electronic access to their health information.
    (ii) Provide patients electronic access to their health information 
measure. Eligible hospitals and CAHs must meet the following measure, 
and could receive up to 40 points for this objective beginning in CY 
2019. For at least one unique patient discharged from the eligible 
hospital or CAH inpatient or emergency department (POS 21 or 23) all of 
the following:
    (A) The patient (or patient-authorized representative) is provided 
timely access to view online, download, and transmit his or her health 
information.
    (B) The eligible hospital or CAH ensures the patient's health 
information is available for the patient (or patient-authorized 
representative) to access using any application of their choice that is 
configured to meet the technical specifications of the API in the 
eligible hospital or CAH's CEHRT.
    (8) Public health and clinical data exchange.--(i) Objective. The 
eligible hospital or CAH is in active engagement with a public health 
agency (PHA) or clinical data registry (CDR) to submit electronic public 
health data in a meaningful way using CEHRT, except where prohibited, 
and in accordance with applicable law and practice.
    (ii) Measures. For CYs 2019, 2020, and 2021, eligible hospitals and 
CAHs could receive a total of 10 points for the objective under 
paragraph (e)(8)(i) of this section. In order to meet the objective 
under paragraph (e)(8)(i) of this section, an eligible hospital or CAH 
must meet any two measures specified in paragraphs (e)(8)(ii)(A) through 
(F) of this section. For CY 2022 and subsequent years, eligible 
hospitals and CAHs could receive a total of 15 points for the objective 
under paragraph (e)(8)(i) of this section. In order to meet the 
objective under paragraph (e)(8)(i) of this section and receive 10 
points, an eligible hospital or CAH must meet each of the four measures 
specified in paragraphs (e)(8)(ii)(A), (B), (C), and (F) of this 
section. An eligible hospital or CAH receives a bonus of 5 points for 
this objective if they meet

[[Page 834]]

one of the measures specified in paragraph (e)(8)(ii)(D) or (E).
    (A) Syndromic surveillance reporting measure. For CYs 2019, 2020, 
and 2021, the eligible hospital or CAH is in active engagement with a 
public health agency to submit syndromic surveillance data from an 
urgent care setting. For CY 2022 and subsequent years, the eligible 
hospital or CAH is in active engagement with a public health agency to 
submit syndromic surveillance data from an emergency department setting 
(POS 23).
    (B) Immunization registry reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
immunization data and receive immunization forecasts and histories from 
the public health immunization registry/immunization information system 
(IIS).
    (C) Electronic case reporting measure. The eligible hospital or CAH 
is in active engagement with a public health agency to submit case 
reporting of reportable conditions.
    (D) Public health registry reporting measure. The eligible hospital 
or CAH is in active engagement with a public health agency to submit 
data to public health registries.
    (E) Clinical data registry reporting measure. The eligible hospital 
or CAH is in active engagement to submit data to a clinical data 
registry.
    (F) Electronic reportable laboratory result reporting measure. The 
eligible hospital or CAH is in active engagement with a public health 
agency to submit electronic reportable laboratory results.
    (iii) Exclusions in accordance with paragraph (e)(2) of this 
section. For CYs 2019, 2020, and 2021, if an exclusion is claimed under 
paragraphs (e)(8)(iii)(A) through (F) of this section for each of the 
two measures selected for reporting, the 10 points for the objective 
specified in paragraph (e)(8)(i) of this section will be redistributed 
to the provide patients electronic access to their health information 
measure under paragraph (e)(7)(ii) of this section. For CY 2022 and 
subsequent years, if an exclusion is claimed under paragraphs 
(e)(8)(iii)(A) through (F) of this section for each of the four measures 
required for reporting, the 10 points for the objective specified in 
paragraph (e)(8)(i) of this section will be redistributed to the provide 
patients electronic access to their health information measure under 
paragraph (e)(7)(ii) of this section.
    (A) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
reporting measure specified in paragraph (e)(8)(ii)(A) of this section 
if the eligible hospital or CAH--
    (1) For CYs 2019, 2020 and 2021, does not have an emergency or 
urgent care department.
    (2) For CY 2022 and subsequent years, does not have an emergency 
department.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs as of 6 months prior to the start of the EHR reporting 
period.
    (B) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from to the immunization registry 
reporting measure specified in paragraph (e)(8)(ii)(B) of this section 
if the eligible hospital or CAH--
    (1) Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period.
    (2) Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (3) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data as of 6 months prior to the start of the EHR reporting 
period.
    (C) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic case reporting 
measure specified in paragraph (e)(8)(ii)(C) of this section if the 
eligible hospital or CAH--

[[Page 835]]

    (1) Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the EHR reporting period.
    (2) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of their 
EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data as of 6 
months prior to the start of the EHR reporting period.
    (D)(1) For CYs 2019, 2020, and 2021, any eligible hospital or CAH 
meeting at least one of the following criteria may be excluded from the 
public health registry reporting measure specified in paragraph 
(e)(8)(ii)(D) of this section if the eligible hospital or CAH:
    (i) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in its jurisdiction during the 
EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no public health registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the EHR reporting period.
    (2) For CY 2022 and subsequent years, the exclusions specified in 
paragraph (D)(1) of this paragraph are no longer available.
    (E)(1) For CYs 2019, 2020, and 2021, any eligible hospital or CAH 
meeting at least one of the following criteria may be excluded from the 
clinical data registry reporting measure specified in paragraph 
(e)(8)(ii)(E) of this section if the eligible hospital or CAH:
    (i) Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period.
    (ii) Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no clinical data registry for 
which the eligible hospital or CAH is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the EHR reporting period.
    (2) For CY 2022 and subsequent years, the exclusions specified in 
paragraph (E)(1) of this paragraph are no longer available.
    (F) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure specified in paragraph (e)(8)(ii)(F) 
of this section if the eligible hospital or CAH--
    (1) Does not perform or order laboratory tests that are reportable 
in its jurisdiction during the EHR reporting period.
    (2) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific ELR standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (3) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from an eligible hospital or CAH as of 6 months prior to the start of 
the EHR reporting period.

[81 FR 79884, Nov. 14, 2016, as amended at 82 FR 38517, August 14, 2017; 
82 FR 46143, Oct. 4, 2017; 83 FR 41707, Aug. 17, 2018; 83 FR 60096, Nov. 
23, 2018; 84 FR 42616, Aug. 16, 2019; 85 FR 59026, Sept. 18, 2020; 86 FR 
45522, Aug. 13, 2021]



Sec. 495.40  Demonstration of meaningful use criteria.

    (a) Demonstration by EPs. An EP must demonstrate that he or she 
satisfies each of the applicable objectives and associated measures 
under Sec. 495.20, Sec. 495.22 or Sec. 495.24, supports information 
exchange and the prevention of health information blocking, and engages 
in activities related to supporting providers with the performance of 
CEHRT:

[[Page 836]]

    (1) For CY 2011--(i) Attestation. Attest, through a secure 
mechanism, in a manner specified by CMS (or for a Medicaid EP, in a 
manner specified by the State), that during the EHR reporting period, 
the EP--
    (A) Used certified EHR technology, and specify the technology used;
    (B) Satisfied the required objectives and associated measures under 
Sec. 495.20 or Sec. 495.24;
    (C) Must specify the EHR reporting period and provide the result of 
each applicable measure for all patients seen during the EHR reporting 
period for which a selected measure is applicable;
    (ii) Additional requirements for Medicaid EPs. For Medicaid EPs, if, 
in accordance with Sec. Sec. 495.316 and 495.332, CMS has approved a 
State's revised definition for meaningful use, in addition to meeting 
paragraphs (a)(1)(i) through (ii) of this section, the EP must also 
demonstrate meeting the State revised definition using the method 
approved by CMS; and
    (iii) Exception for Medicaid EPs. If a Medicaid EP has adopted, 
implemented or upgraded certified EHR technology in the first payment 
year, the EP need not demonstrate meaningful use until the second 
payment year, as described in Sec. 495.20 or Sec. Sec. 495.24 and 
495.40.
    (2) For CY 2012 and subsequent years--
    (i) Attestation. Attest, through a secure mechanism, in a manner 
specified by CMS (or for a Medicaid EP, in a manner specified by the 
State) that during the EHR reporting period, the EP--
    (A) Used certified EHR technology and specify the technology used.
    (B) For calendar years before 2015, satisfied the required 
objectives and associated measures under Sec. 495.20 for the EP's stage 
of meaningful use.
    (C) Must specify the EHR reporting period and provide the result of 
each applicable measure for all patients seen during the EHR reporting 
period for which a selected measure is applicable.
    (D) For 2014 only, if the EP uses one of the options specified in 
Sec. 495.20(a)(4) or (h)(3), the EP must attest that he or she is 
unable to fully implement 2014 Edition certified EHR technology for an 
EHR reporting period in 2014 due to delays in 2014 Edition certified EHR 
technology availability.
    (E) For CYs 2015 through 2016, satisfied the required objectives and 
associated measures under Sec. 495.22(e) for meaningful use.
    (F) For CY 2017 and CY 2018: An EP that has successfully 
demonstrated it is a meaningful EHR user in any prior year may satisfy 
either the objectives and measures specified in Sec. 495.22(e) for 
meaningful use or the objectives and measures specified in Sec. 
495.24(d) for meaningful use; an EP that has never successfully 
demonstrated it is a meaningful EHR user in any prior year must satisfy 
the objectives and measures specified in Sec. 495.22(e) for meaningful 
use.
    (G) For CY 2019 and subsequent years, satisfied the required 
objectives and associated measures under Sec. 495.24(d) for meaningful 
use.
    (H) Supporting providers with the performance of CEHRT (SPPC). To 
engage in activities related to supporting providers with the 
performance of CEHRT, the EP--
    (1) Must attest that he or she:
    (i) Acknowledges the requirement to cooperate in good faith with ONC 
direct review of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC direct review is received; and
    (ii) If requested, cooperated in good faith with ONC direct review 
of his or her health information technology certified under the ONC 
Health IT Certification Program as authorized by 45 CFR part 170, 
subpart E, to the extent that such technology meets (or can be used to 
meet) the definition of CEHRT, including by permitting timely access to 
such technology and demonstrating its capabilities as implemented and 
used by the EP in the field.
    (2) Optionally, may also attest that he or she:
    (i) Acknowledges the option to cooperate in good faith with ONC-ACB 
surveillance of his or her health information technology certified under 
the ONC Health IT Certification Program if a request to assist in ONC-
ACB surveillance is received; and

[[Page 837]]

    (ii) If requested, cooperated in good faith with ONC-ACB 
surveillance of his or her health information technology certified under 
the ONC Health IT Certification Program as authorized by 45 CFR part 
170, subpart E, to the extent that such technology meets (or can be used 
to meet) the definition of CEHRT, including by permitting timely access 
to such technology and demonstrating capabilities as implemented and 
used by the EP in the field.
    (I) Support for health information exchange and the prevention of 
information blocking. For an EHR reporting period in CY 2017 and 
subsequent years, the EP must attest that he or she--
    (1) Did not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (2) Implemented technologies, standards, policies, practices, and 
agreements reasonably calculated to ensure, to the greatest extent 
practicable and permitted by law, that the certified EHR technology was, 
at all relevant times--
    (i) Connected in accordance with applicable law;
    (ii) Compliant with all standards applicable to the exchange of 
information, including the standards, implementation specifications, and 
certification criteria adopted at 45 CFR part 170;
    (iii) Implemented in a manner that allowed for timely access by 
patients to their electronic health information; and
    (iv) Implemented in a manner that allowed for the timely, secure, 
and trusted bi-directional exchange of structured electronic health 
information with other health care providers (as defined by 42 U.S.C. 
300jj(3)), including unaffiliated providers, and with disparate 
certified EHR technology and vendors.
    (3) Responded in good faith and in a timely manner to requests to 
retrieve or exchange electronic health information, including from 
patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and 
other persons, regardless of the requestor's affiliation or technology 
vendor.
    (ii) Reporting clinical quality information. Successfully report the 
clinical quality measures selected by CMS to CMS or the States, as 
applicable, in the form and manner specified by CMS or the States, as 
applicable.
    (iii) Additional requirements for Medicaid EPs. For Medicaid EPs, 
if, in accordance with Sec. Sec. 495.316 and 495.332, CMS has approved 
a State's additional criteria for meaningful use, in addition to meeting 
paragraphs (a)(2)(i) through (iii), the EP must also demonstrate meeting 
such additional criteria using the method approved by CMS.
    (iv) Exception for Medicaid EPs. If a Medicaid EP has adopted, 
implemented, or upgrade certified EHR technology in the first payment 
year, the EP need not demonstrate that it is a meaningful EHR user until 
the second payment year, as described in Sec. 495.20 or Sec. Sec. 
495.24 and 495.40.
    (v) Exception for Medicare EPs for 2012 and 2013--Participation in 
the Physician Quality Reporting System-Medicare EHR Incentive Pilot. To 
satisfy the clinical quality measure reporting requirements of 
meaningful use, aside from attestation, an EP participating in the 
Physician Quality Reporting System may also participate in the Physician 
Quality Reporting System-Medicare EHR Incentive Pilot through one of the 
following methods:
    (A) Submission of data extracted from the EP's certified EHR 
technology through a Physician Quality Reporting System qualified EHR 
data submission vendor; or
    (B) Submission of data extracted from the EP's certified EHR 
technology, which must also be through a Physician Quality Reporting 
System qualified EHR.
    (3) For all CYs, an EP who practices in multiple physical locations, 
not all of which have certified EHR technology available, will 
demonstrate meaningful use using only the locations where the EP has 
certified EHR technology available. (See also Sec. 495.4 regarding the 
definition of meaningful EHR user).
    (b) Demonstration by eligible hospitals and CAHs. An eligible 
hospital or CAH must demonstrate that it satisfies each of the 
applicable objectives and associated measures under Sec. 495.20, Sec. 
495.22, or

[[Page 838]]

Sec. 495.24; supports health information exchange and the prevention of 
health information blocking or does not take actions to limit or 
restrict the compatibility or interoperability of CEHRT, as applicable 
for the EHR reporting period; and engages in activities related to 
supporting providers with the performance of CEHRT.
    (1) For FY 2011--
    (i) Attestation. Attest, through a secure mechanism, in a manner 
specified by CMS (or for a Medicaid eligible hospital, in a manner 
specified by the State), that during the EHR reporting period, the 
eligible hospital or CAH--
    (A) Used certified EHR and specify the technology used.
    (B) Satisfied the required objectives and associated measures under 
Sec. 495.20 or Sec. 495.24.
    (C) Must specify the EHR reporting period and provide the result of 
each applicable measure for all patients admitted to the inpatient or 
emergency department (POS 21 or 23) of the hospital during the EHR 
reporting period for which a selected measure is applicable.
    (ii) Additional requirements for Medicaid eligible hospitals. For 
Medicaid eligible hospitals, if, in accordance with Sec. Sec. 495.316 
and 495.332, CMS has approved a State's revised definition for 
meaningful use, in addition to meeting paragraphs (b)(1)(i) through (ii) 
of this section, the eligible hospital must also demonstrate meeting the 
State's revised definition using the method approved by CMS.
    (iii) Exception for Medicaid eligible hospitals. If a Medicaid 
eligible hospital has adopted, implemented or upgraded certified EHR 
technology in the first payment year, the eligible hospital need not 
demonstrate meaningful use until the second payment year, as described 
in Sec. 495.20 or Sec. Sec. 495.24 and 495.40.
    (2) For FY 2012 and subsequent years--
    (i) Attestation. Attest, through a secure mechanism, in a manner 
specified by CMS (or for a Medicaid eligible hospital, in a manner 
specified by the State), that during the EHR reporting period, the 
eligible hospital or CAH--
    (A) Used certified EHR and specify the technology used;
    (B) For fiscal years before 2015, satisfied the required objectives 
and associated measures under Sec. 495.20 for the eligible hospital or 
CAH's stage of meaningful use.
    (C) Must specify the EHR reporting period and provide the result of 
each applicable measure for all patients admitted to the inpatient or 
emergency department (POS 21 or 23) of the hospital during the EHR 
reporting period for which a selected measure is applicable.
    (D) For 2014 only, if the eligible hospital or CAH uses one of the 
options specified in Sec. 495.20(b)(4) or (h)(3), it must attest that 
it is unable to fully implement 2014 Edition certified EHR technology 
for an EHR reporting period in 2014 due to delays in 2014 Edition 
certified EHR technology availability.
    (E) For CYs 2015 through 2016, satisfied the required objectives and 
associated measures under Sec. 495.22(e) for meaningful use.
    (F) For CY 2017 and CY 2018:
    (1) For an eligible hospital or CAH attesting to CMS: An eligible 
hospital or CAH that has successfully demonstrated it is a meaningful 
EHR user in any prior year may satisfy either the objectives and 
measures specified in Sec. 495.22(f) for meaningful use or the 
objectives and measures specified in Sec. 495.24(c) for meaningful use; 
an eligible hospital or CAH that has never successfully demonstrated it 
is a meaningful EHR user in any prior year must satisfy the objectives 
and measures specified in Sec. 495.22(f) for meaningful use.
    (2) For an eligible hospital or CAH attesting to a State for the 
Medicaid EHR Incentive Program: An eligible hospital or CAH that has 
successfully demonstrated it is a meaningful EHR user in any prior year 
may satisfy either the objectives and measures specified in Sec. 
495.22(e) for meaningful use or the objectives and measures specified in 
Sec. 495.24(d) for meaningful use; an eligible hospital or CAH that has 
never successfully demonstrated it is a meaningful EHR user in any prior 
year must satisfy the objectives and measures specified in Sec. 
495.22(e) for meaningful use.
    (G) For CY 2019:

[[Page 839]]

    (1) For an eligible hospital or CAH attesting to CMS, satisfied the 
required objectives and associated measures under Sec. 495.24(c) for 
meaningful use.
    (2) For an eligible hospital or CAH attesting to a State for the 
Medicaid EHR Incentive Program, satisfied the required objectives and 
associated measures under Sec. 495.24(d) for meaningful use.
    (H) Supporting providers with the performance of CEHRT (SPPC). To 
engage in activities related to supporting providers with the 
performance of CEHRT, the eligible hospital or CAH--
    (1) Must attest that it:
    (i) Acknowledges the requirement to cooperate in good faith with ONC 
direct review of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC direct review is received; and
    (ii) If requested, cooperated in good faith with ONC direct review 
of its health information technology certified under the ONC Health IT 
Certification Program as authorized by 45 CFR part 170, subpart E, to 
the extent that such technology meets (or can be used to meet) the 
definition of CEHRT, including by permitting timely access to such 
technology and demonstrating its capabilities as implemented and used by 
the eligible hospital or CAH in the field.
    (2) Optionally, may attest that it:
    (i) Acknowledges the option to cooperate in good faith with ONC-ACB 
surveillance of his or her health information technology certified under 
the ONC Health IT Certification Program if a request to assist in ONC-
ACB surveillance is received; and
    (ii) If requested, cooperated in good faith with ONC-ACB 
surveillance of his or her health information technology certified under 
the ONC Health IT Certification Program as authorized by 45 CFR part 
170, subpart E, to the extent that such technology meets (or can be used 
to meet) the definition of CEHRT, including by permitting timely access 
to such technology and demonstrating its capabilities as implemented and 
used by the eligible hospital or CAH in the field.
    (I) Support for health information exchange and the prevention of 
information blocking. For an EHR reporting period in CYs 2017 through 
2021, the eligible hospital or CAH must attest that it--
    (1) Did not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (2) Implemented technologies, standards, policies, practices, and 
agreements reasonably calculated to ensure, to the greatest extent 
practicable and permitted by law, that the certified EHR technology was, 
at all relevant times--
    (i) Connected in accordance with applicable law;
    (ii) Compliant with all standards applicable to the exchange of 
information, including the standards, implementation specifications, and 
certification criteria adopted at 45 CFR part 170;
    (iii) Implemented in a manner that allowed for timely access by 
patients to their electronic health information; and
    (iv) Implemented in a manner that allowed for the timely, secure, 
and trusted bi-directional exchange of structured electronic health 
information with other health care providers (as defined by 42 U.S.C. 
300jj(3)), including unaffiliated providers, and with disparate 
certified EHR technology and vendors.
    (3) Responded in good faith and in a timely manner to requests to 
retrieve or exchange electronic health information, including from 
patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and 
other persons, regardless of the requestor's affiliation or technology 
vendor.
    (J) Actions to limit or restrict the compatibility or 
interoperability of CEHRT. For an EHR reporting period in CY 2022 and 
subsequent years, the eligible hospital or CAH must attest that it did 
not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (ii) Reporting clinical quality information. Successfully report the 
clinical

[[Page 840]]

quality measures selected by CMS to CMS or the States, as applicable, in 
the form and manner specified by CMS or the States, as applicable.
    (iii) [Reserved]
    (iv) Additional requirements for Medicaid eligible hospitals. For 
Medicaid eligible hospitals if, in accordance with Sec. Sec. 495.316 
and 495.332, CMS has approved a State's revised definition for 
meaningful use, in addition to meeting paragraphs (b)(2)(i) through 
(iii) of this section, the eligible hospital must also demonstrate 
meeting the State's revised definition using the method approved by CMS.
    (v) Exception for Medicare EPs for 2012 and 2013--Participation in 
the Physician Quality Reporting System-Medicare EHR Incentive Pilot. To 
satisfy the clinical quality measure reporting requirements of 
meaningful use, aside from attestation, an EP participating in the 
Physician Quality Reporting System may also participate in the Physician 
Quality Reporting System-Medicare EHR Incentive Pilot through one of the 
following methods:
    (A) Submission of data extracted from the EP's certified EHR 
technology through a Physician Quality Reporting System qualified EHR 
data submission vendor; or
    (B) Submission of data extracted from the EP's certified EHR 
technology, which must also be through a Physician Quality Reporting 
System qualified EHR.
    (vi) Exception for Medicare eligible hospitals and CAHs for FY 2012 
and 2013--Participation in the Medicare EHR Incentive Program Electronic 
Reporting Pilot. In order to satisfy the clinical quality measure 
reporting requirements of meaningful use, aside from attestation, a 
Medicare eligible hospital or CAH may participate in the Medicare EHR 
Incentive Program Electronic Reporting Pilot.
    (vii) Exception for dual-eligible eligible hospitals and CAHs 
beginning in CY 2019. (A) Beginning with the EHR reporting period in CY 
2019, dual-eligible eligible hospitals and CAHs (those that are eligible 
for an incentive payment under Medicare for meaningful use of CEHRT and/
or subject to the Medicare payment reduction for failing to demonstrate 
meaningful use, and are also eligible to earn a Medicaid incentive 
payment for meaningful use) must satisfy the requirements under 
paragraph (b)(2) of this section by attestation and reporting 
information to CMS, not to their respective state Medicaid agency.
    (B) Dual-eligible eligible hospitals and CAHs that demonstrate 
meaningful use to their state Medicaid agency may only qualify for an 
incentive payment under Medicaid and will not qualify for an incentive 
payment under Medicare and/or avoid the Medicare payment reduction.
    (c) Review of meaningful use. (1) CMS (and in the case of Medicaid 
EPs and eligible hospitals, States) may review an EP, eligible hospital 
or CAH's demonstration of meaningful use.
    (2) All EPs, eligible hospitals, and CAHs must keep documentation 
supporting their demonstration of meaningful use for 6 years.

[75 FR 44565, July 28, 2010, as amended at 76 FR 73473, Nov. 28, 2011; 
76 FR 74584, Nov. 30, 2011; 77 FR 54157, Sept. 4, 2012; 77 FR 68565, 
Nov. 15, 2012; 77 FR 69372, Nov. 16, 2012; 79 FR 52933, Sept. 4, 2014. 
Redesignated and amended at 80 FR 62943, 62954, Oct. 16, 2015; 81 FR 
77556, Nov. 4, 2016; 81 FR 79892, Nov. 14, 2016; 82 FR 36, Jan. 3, 2017; 
82 FR 16742, Apr. 6, 2017; 82 FR 38518, Aug. 14, 2017; 83 FR 41710, Aug. 
17, 2018; 86 FR 45523, Aug. 13, 2021]



Sec. 495.60  Participation requirements for EPs, eligible hospitals,
and CAHs.

    (a) An eligible hospital, CAH or EP must submit in a manner 
specified by CMS the following information in the first payment year:
    (1) Name of the EP, eligible hospital or CAH.
    (2) National Provider Identifier (NPI).
    (3) Business address, business email address, and phone number.
    (4) Such other information as specified by CMS.
    (b) In addition to the information submitted under paragraph (a) of 
this section, an eligible hospital or CAH, must, in the first payment 
year, submit in a manner specified by CMS its CMS Certification Number 
(CCN) and its Taxpayer Identification Number (TIN).
    (c) Subject to paragraph (f) of this section, in addition to the 
information submitted under paragraph (a) of this

[[Page 841]]

section, an EP must submit in a manner specified by CMS, the Taxpayer 
Identification Number (TIN) which may be the EP's Social Security Number 
(SSN) to which the EP's incentive payment should be made.
    (d) In the event the information specified in paragraphs (a) through 
(c) of this section as previously submitted to CMS is no longer 
accurate, the EP, eligible hospital or CAH must provide updated 
information to CMS or the State on a timely basis in the manner 
specified by CMS or the State.
    (e) An EP that qualifies as both a Medicaid EP and Medicare EP--
    (1) Must notify CMS in the manner specified by CMS as to whether he 
or she elects to participate in the Medicare or the Medicaid EHR 
incentive program;
    (2) After receiving at least one EHR incentive payment, may switch 
between the two EHR incentive programs only one time, and only for a 
payment year before 2015;
    (3) Must, for each payment year, meet all of the applicable 
requirements, including applicable patient volume requirements, for the 
program in which he or she chooses to participate (Medicare or 
Medicaid);
    (4) Is limited to receiving, in total, the maximum payments the EP 
would receive under the Medicaid EHR program, as described in subpart D 
of this part; and
    (5) Is placed in the payment year the EP would have been in had the 
EP begun in and remained in the program to which he or she has switched. 
For example, an EP that begins receiving Medicaid incentive payments in 
2011, and then switches to the Medicare program for 2012, is in his or 
her second payment year in 2012.
    (f) Limitations on incentive payment reassignments. (1) EPs are 
permitted to reassign their incentive payments to their employer or to 
an entity with which they have a contractual arrangement allowing the 
employer or entity to bill and receive payment for the EP's covered 
professional services.
    (2)(i) Assignments in Medicare must be consistent with Section 
1842(b)(6)(A) of the Act and 42 CFR part 424 subpart F.
    (ii) Medicaid EPs may also assign their incentive payments to a TIN 
for an entity promoting the adoption of EHR technology, consistent with 
subpart D of this part.
    (3) Each EP may reassign the entire amount of the incentive payment 
to only one employer or entity.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54157, Sept. 4, 2012. 
Redesignated at 80 FR 62943, Oct. 16, 2015]



         Subpart B_Requirements Specific to the Medicare Program



Sec. 495.100  Definitions.

    In this subpart unless otherwise indicated--
    Covered professional services means (as specified in section 
1848(k)(3) of the Act) services furnished by an EP for which payment is 
made under, or is based on, the Medicare physician fee schedule.
    Eligible hospital means a hospital subject to the prospective 
payment system specified in Sec. 412.1(a)(1) of this chapter, excluding 
those hospitals specified in Sec. 412.23 of this chapter, excluding 
those hospital units specified in Sec. 412.25 of this chapter, and 
including Puerto Rico eligible hospitals unless otherwise indicated.
    Eligible professional (EP) means a physician as defined in section 
1861(r) of the Act, which includes, with certain limitations, all of the 
following types of professionals:
    (1) A doctor of medicine or osteopathy.
    (2) A doctor of dental surgery or medicine.
    (3) A doctor of podiatric medicine.
    (4) A doctor of optometry.
    (5) A chiropractor.
    Geographic health professional shortage area (HPSA) means a 
geographic area that is designated by the Secretary under section 
332(a)(1)(A) of the PHS Act as of December 31 of the year prior to the 
payment year as having a shortage of health professionals.
    Puerto Rico eligible hospital means a subsection (d) Puerto Rico 
hospital as defined in section 1886(d)(9)(A) of the Social Security Act.
    Qualifying CAH means a CAH that is a meaningful EHR user for the EHR 
reporting period applicable to a payment

[[Page 842]]

year or payment adjustment year in which a cost reporting period begins.
    Qualifying eligible professional (qualifying EP) means an EP who is 
a meaningful EHR user for the EHR reporting period applicable to a 
payment or payment adjustment year and who is not a hospital-based EP, 
as determined for that payment or payment adjustment year.
    Qualifying hospital means an eligible hospital that is a meaningful 
EHR user for the EHR reporting period applicable to a payment or payment 
adjustment year.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54157, Sept. 4, 2012; 
83 FR 41710, Aug. 17, 2018]



Sec. 495.102  Incentive payments to EPs.

    (a) General rules. (1) Subject to paragraph (b) of this section, in 
addition to the amount otherwise paid under section 1848 of the Act, 
there must be paid to a qualifying EP (or to an employer or entity in 
the cases described in section 1842(b)(6)(A) of the Act) for a payment 
year an amount equal to 75 percent of the estimated allowed charges for 
covered professional services furnished by the EP during the payment 
year.
    (2) For purposes of this paragraph (a) of this section, the 
estimated allowed charges for the qualifying EP's covered professional 
services during the payment year are determined based on claims 
submitted no later than 2 months after the end of the payment year, and, 
in the case of a qualifying EP who furnishes covered professional 
services in more than one practice, are determined based on claims 
submitted for the EP's covered professional services across all such 
practices.
    (b) Limitations on amounts of incentive payments. (1) Except as 
otherwise provided in paragraphs (b)(2) and (c) of this section, the 
amount of the incentive payment under paragraph (a) of this section for 
each payment year is limited to the following amounts:
    (i) For the first payment year, $15,000 (or, if the first payment 
year for such qualifying EP is 2011 or 2012, $18,000).
    (ii) For the second payment year, $12,000.
    (iii) For the third payment year, $8,000.
    (iv) For the fourth payment year, $4,000.
    (v) For the fifth payment year, $2,000.
    (vi) For any succeeding payment year for such professional, $0.
    (2)(i) If the first payment year for a qualifying EP is 2014, then 
the payment limit for a payment year for the qualifying EP is the same 
as the amount specified in paragraph (b)(1) of this section for such 
payment year for a qualifying EP whose first payment year is 2013.
    (ii) If the first payment year for a qualifying EP is after 2014, 
then the payment limit specified in this paragraph for such EP for such 
year and any subsequent year is $0.
    (c) Increase in incentive payment limit for EPs who predominantly 
furnish services in a geographic HPSA. In the case of a qualifying EP 
who furnishes more than 50 percent of his or her covered professional 
services during the payment year in a geographic HPSA that is designated 
as of December 31 of the prior year, the incentive payment limit 
determined under paragraph (b) of this section is to be increased by 10 
percent.
    (d) Payment adjustment effective in CY 2015 and subsequent years for 
nonqualifying EPs. (1) Subject to paragraphs (d)(3) and (4) of this 
section, for CY 2015 through the end of CY 2018, for covered 
professional services furnished by an EP who is not hospital-based, and 
who is not a qualifying EP by virtue of not being a meaningful EHR user 
(for the EHR reporting period applicable to the payment adjustment 
year), the payment amount for such services is equal to the product of 
the applicable percent specified in paragraph (d)(2) of this section and 
the Medicare physician fee schedule amount for such services.
    (2) Applicable percent. Applicable percent is as follows:
    (i) For 2015, 99 percent if the EP is not subject to the payment 
adjustment for an EP who is not a successful electronic prescriber under 
section 1848(a)(5) of the Act, or 98 percent if the EP is subject to the 
payment adjustment for an EP who is not a successful electronic 
prescriber under section 1848(a)(5) of the Act).
    (ii) For 2016, 98 percent.
    (iii) For 2017, 97 percent.

[[Page 843]]

    (iv) For 2018, 97 percent, except as provided in paragraph (d)(3) of 
this section.
    (3) Decrease in applicable percent in certain circumstances. In CY 
2018, if the Secretary finds that the proportion of EPs who are 
meaningful EHR users is less than 75 percent, the applicable percent 
must be decreased by 1 percentage point for EPs from the applicable 
percent in the preceding year.
    (4) Exceptions. The Secretary may, on a case-by-case basis, exempt 
an EP from the application of the payment adjustment under paragraph 
(d)(1) of this section if the Secretary determines that compliance with 
the requirement for being a meaningful EHR user would result in a 
significant hardship for the EP. To be considered for an exception, an 
EP must submit, in the manner specified by CMS, an application 
demonstrating that it meets one or more of the criteria in this 
paragraph (d)(4) unless otherwise specified in the criteria. The 
Secretary's determination to grant an EP an exemption may be renewed on 
an annual basis, provided that in no case may an EP be granted an 
exemption for more than 5 years.
    (i) During any 90-day period from the beginning of the year that is 
2 years before the payment adjustment year to July 1 of the year 
preceding the payment adjustment year, or a later date specified by CMS, 
the EP was located in an area without sufficient Internet access to 
comply with the meaningful use objectives requiring internet 
connectivity, and faced insurmountable barriers to obtaining such 
internet connectivity. Applications requesting this exception must be 
submitted no later than July 1 of the year before the applicable payment 
adjustment year, or a later date specified by CMS.
    (ii) The EP has been practicing for less than 2 years.
    (iii)(A) During the calendar year that is 2 calendar years before 
the payment adjustment year, the EP that has previously demonstrated 
meaningful use faces extreme and uncontrollable circumstances that 
prevent it from becoming a meaningful EHR user. Applications requesting 
this exception must be submitted no later than July 1 of the year before 
the applicable payment adjustment year, or a later date specified by 
CMS.
    (B) During the calendar year preceding the payment adjustment year, 
the EP that has not previously demonstrated meaningful use faces extreme 
and uncontrollable circumstances that prevent it from becoming a 
meaningful EHR user. Applications requesting this exception must be 
submitted by July 1 of the year before the applicable payment adjustment 
year, or a later date specified by CMS.
    (iv) An EP may request an exception through an application submitted 
by July 1 of the year before the applicable payment adjustment year, or 
a later date specified by CMS due to difficulty in meeting meaningful 
use based on any one of the following during the period that begins 2 
calendar years before the payment adjustment year through the 
application deadline:
    (A) The EP practices at multiple locations and can demonstrate 
inability to control the availability of Certified EHR Technology at one 
such practice location or a combination of practice locations, and where 
the location or locations constitute more than 50 percent of their 
patient encounters.
    (B) The EP can demonstrate difficulty in meeting meaningful use on 
the basis of lack of face-to-face or telemedicine interaction with 
patients and lack of need for follow up with patients.
    (C) The EP has a primary specialty listed in PECOS as 
anesthesiology, radiology or pathology 6 months prior to the first day 
of the payment adjustments that would otherwise apply. Such an EP may be 
deemed to qualify for this exception, subject to the 5-year limit that 
applies to all exceptions under this paragraph.
    (v) For the 2018 payment adjustment only, an EP who has not 
successfully demonstrated meaningful use in a prior year, intends to 
attest to meaningful use for an EHR reporting period in 2017 by October 
1, 2017 to avoid the 2018 payment adjustment, and intends to transition 
to the Merit-Based Incentive Payment System (MIPS) and report on 
measures specified for the advancing care information performance 
category under the MIPS in 2017. The EP must

[[Page 844]]

explain in the application why demonstrating meaningful use for an EHR 
reporting period in 2017 would result in a significant hardship. 
Applications requesting this exception must be submitted no later than 
October 1, 2017, or a later date specified by CMS.
    (5) Exception for decertified EHR technology. The Secretary shall 
exempt an EP from the application of the payment adjustment for CY 2018 
under paragraph (d)(1) of this section if the Secretary determines that 
compliance with the requirement for being a meaningful EHR user is not 
possible because the certified EHR technology used by the EP has been 
decertified under ONC's Health IT Certification Program. To be 
considered for an exception, an EP must submit, in the manner specified 
by CMS, an application demonstrating that the certified EHR technology 
was decertified during the 12-month period preceding the applicable EHR 
reporting period for the CY 2018 payment adjustment year, or during the 
applicable EHR reporting period for the CY 2018 payment adjustment year, 
and that the EP made a good faith effort to obtain another certified EHR 
technology for that EHR reporting period. Applications requesting this 
exception must be submitted no later than October 1, 2017, or a later 
date specified by CMS.
    (6) Payment adjustments not applicable to hospital-based EPs. No 
payment adjustment under paragraphs (d)(1) through (3) of this section 
may be made in the case of a hospital-based eligible professional, as 
defined in Sec. 495.4.
    (7) Payment adjustments not applicable to ambulatory surgical 
center-based EPs. For the CY 2017 and CY 2018 payment adjustment years, 
no payment adjustment under paragraphs (d)(1) through (3) of this 
section may be made in the case of an ambulatory surgical center-based 
eligible professional, as defined in Sec. 495.4.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54157, Sept. 4, 2012; 
77 FR 54157, Sept. 4, 2012; 79 FR 68009, Nov. 13, 2014; 81 FR 77557, 
Nov. 4, 2016; 81 FR 79892, Nov. 14, 2016; 82 FR 38518, Aug. 14, 2017]



Sec. 495.104  Incentive payments to eligible hospitals.

    (a) General rule. A qualifying hospital (as defined in this subpart) 
must receive the special incentive payment as determined under the 
formulas described in paragraph (c) of this section for the period 
specified in paragraph (b) of this section.
    (b) Transition periods. Subject to paragraph (d) of this section and 
the payment formula specified in paragraph (c) of this section, 
qualifying hospitals may receive incentive payments during transition 
periods which comprise the following fiscal years:
    (1) Hospitals whose first payment year is FY 2011 may receive such 
payments for FYs 2011 through 2014.
    (2) Hospitals whose first payment year is FY 2012 may receive such 
payments for FYs 2012 through 2015.
    (3) Hospitals whose first payment year is FY 2013 may receive such 
payments for FYs 2013 through 2016.
    (4) Hospitals whose first payment year is FY 2014 may receive such 
payments for FY 2014 through 2016.
    (5) Hospitals whose first payment year is FY 2015 may receive such 
payments for FY 2015 through 2016.
    (6) Puerto Rico eligible hospitals whose first payment year is FY 
2016 may receive such payments for FYs 2016 through 2019.
    (7) Puerto Rico eligible hospitals whose first payment year is FY 
2017 may receive such payments for FYs 2017 through 2020.
    (8) Puerto Rico eligible hospitals whose first payment year is FY 
2018 may receive such payments for FYs 2018 through 2021.
    (9) Puerto Rico eligible hospitals whose first payment year is FY 
2019 may receive such payments for FYs 2019 through 2021.
    (10) Puerto Rico eligible hospitals whose first payment year is FY 
2020 may receive such payments for FYs 2020 through 2021.
    (c) Payment methodology. (1) The incentive payment for each payment 
year is calculated as the product of the following:
    (i) The initial amount determined under paragraph (c)(3) of this 
section.

[[Page 845]]

    (ii) The Medicare share fraction determined under paragraph (c)(4) 
of this section.
    (iii) The transition factor determined under paragraph (c)(5) of 
this section.
    (2) Interim and final payments. CMS uses data on hospital acute care 
inpatient discharges, Medicare Part A acute care inpatient bed-days, 
Medicare Part C acute care inpatient bed-days, and total acute care 
inpatient bed-days from the latest submitted 12-month hospital cost 
report as the basis for making preliminary incentive payments. Final 
payments are determined at the time of settling the first 12-month 
hospital cost report for the hospital fiscal year that begins on or 
after the first day of the payment year, and settled on the basis of 
data from that cost reporting period. In cases where there is no 12-
month hospital cost report period beginning on or after the first day of 
the payment year, final payments may be determined and settled on the 
basis of data from the most recently submitted 12-month hospital cost 
report.
    (3) Initial amount. The initial amount is equal to one of the 
following:
    (i) For each hospital with 1,149 acute care inpatient discharges or 
fewer, $2,000,000.
    (ii) For each hospital with at least 1,150 but no more than 23,000 
acute care inpatient discharges, $2,000,000 + [$200 x (n - 1,149)], 
where n is the number of discharges for the hospital.
    (iii) For each hospital with more than 23,000 acute care inpatient 
discharges, $6,370,200.
    (4) Medicare share fraction--(i) General. (A) CMS determines the 
Medicare share fraction for an eligible hospital by using the number of 
Medicare Part A, Medicare Part C, and total acute care inpatient-bed-
days using data from the Medicare cost report as specified by CMS.
    (B) CMS computes the denominator of the Medicare share fraction 
using the charity care charges reported on the hospital's Medicare cost 
report.
    (ii) The Medicare share fraction is the ratio of--
    (A) A numerator which is the sum of--
    (1) The number of inpatient-bed-days which are attributable to 
individuals with respect to whom payment may be made under Part A, 
including individuals enrolled in section 1876 Medicare cost plans; and
    (2) The number of inpatient-bed-days which are attributable to 
individuals who are enrolled with a Medicare Advantage organization (as 
defined in Sec. 422.2 of this chapter).
    (B) A denominator which is the product of--
    (1) The total number of acute care inpatient-bed-days; and
    (2) The total amount of the eligible hospital's charges, not 
including any charges that are attributable to charity care, divided by 
the estimated total amount of the hospitals charges.
    (5) Transition factor. For purposes of the payment formula, the 
transition factor is as follows:
    (i) For hospitals whose first payment year is FY 2011--
    (A) 1 for FY 2011;
    (B) \3/4\ for FY 2012;
    (C) \1/2\ for FY 2013; and
    (D) \1/4\ for FY 2014.
    (ii) For hospitals whose first payment year is FY 2012--
    (A) 1 for FY 2012;
    (B) \3/4\ for FY 2013;
    (C) \1/2\ for FY 2014; and
    (D) \1/4\ for FY 2015;
    (iii) For hospitals whose first payment year is FY 2013--
    (A) 1 for FY 2013;
    (B) \3/4\ for FY 2014;
    (C) \1/2\ for FY 2015; and
    (D) \1/4\ for FY 2016.
    (iv) For hospitals whose first payment year is FY 2014--
    (A) \3/4\ for FY 2014;
    (B) \1/2\ for FY 2015; and
    (C) \1/4\ for FY 2016.
    (v) For hospitals whose first payment year is FY 2015--
    (A) \1/2\ for FY 2015; and
    (B) \1/4\ for FY 2016.
    (vi) For Puerto Rico eligible hospitals whose first payment year is 
FY 2016--
    (A) 1 for FY 2016;
    (B) \3/4\ for FY 2017;
    (C) \1/2\ for FY 2018; and
    (D) \1/4\ for FY 2019.
    (vii) For Puerto Rico eligible hospitals whose first payment year is 
FY 2017--
    (A) 1 for FY 2017;

[[Page 846]]

    (B) \3/4\ for FY 2018;
    (C) \1/2\ for FY 2019; and
    (D) \1/4\ for FY 2020;
    (viii) For Puerto Rico eligible hospitals whose first payment year 
is FY 2018--
    (A) 1 for FY 2018;
    (B) \3/4\ for FY 2019;
    (C) \1/2\ for FY 2020; and
    (D) \1/4\ for FY 2021.
    (ix) For Puerto Rico eligible hospitals whose first payment year is 
FY 2019--
    (A) \3/4\ for FY 2019;
    (B) \1/2\ for FY 2020; and
    (C) \1/4\ for FY 2021.
    (x) For Puerto Rico eligible hospitals whose first payment year is 
FY 2020--
    (A) \1/2\ for FY 2020; and
    (B) \1/4\ for FY 2021.
    (d) No incentive payment for nonqualifying hospitals. After the 
first payment year, an eligible hospital will not receive an incentive 
payment for any payment year during which it is not a qualifying 
hospital.

[75 FR 44565, July 28, 2010, as amended at 78 FR 75200, Dec. 10, 2013; 
83 FR 41710, Aug. 17, 2018; 85 FR 59027, Sept. 18, 2020]



Sec. 495.106  Incentive payments to CAHs.

    (a) Definitions. In this section, unless otherwise indicated--
    Payment year means a Federal fiscal year beginning after FY 2010 but 
before FY 2016.
    Qualifying CAH means a CAH that would meet the definition of a 
meaningful EHR user at Sec. 495.4, if it were an eligible hospital.
    Reasonable costs incurred for the purchase of certified EHR 
technology for a qualifying CAH means the reasonable acquisition costs 
incurred for the purchase of depreciable assets as described in part 413 
subpart G of this chapter, such as computers and associated hardware and 
software, necessary to administer certified EHR technology as defined in 
Sec. 495.4, excluding any depreciation and interest expenses associated 
with the acquisition.
    (b) General rule. A qualifying CAH receives an incentive payment for 
its reasonable costs incurred for the purchase of certified EHR 
technology, as defined in paragraph (a) of this section, in the manner 
described in paragraph (c) of this section for a cost reporting period 
beginning during a payment year as defined in paragraph (a) of this 
section.
    (c) Payment methodology--(1) Payment amount. A qualifying CAH 
receives an incentive payment amount equal to the product of its 
reasonable costs incurred for the purchase of certified EHR technology 
and the Medicare share percentage.
    (2) Calculation of reasonable costs. CMS or its Medicare contractor 
computes a qualifying CAH's reasonable costs incurred for the purchase 
of certified EHR technology, as defined in paragraph (a) of this 
section, as the sum of--
    (i) The reasonable costs incurred for the purchase of certified EHR 
technology during the cost reporting period that begins in a payment 
year; and
    (ii) Any reasonable costs incurred for the purchase of certified EHR 
technology in cost reporting periods beginning in years prior to the 
payment year which have not been fully depreciated as of the cost 
reporting period beginning in the payment year.
    (3) Medicare share percentage. Notwithstanding the percentage 
applicable under Sec. 413.70(a)(1) of this chapter, the Medicare share 
percentage equals the lesser of--
    (i) 100 percent; or
    (ii) The sum of the Medicare share fraction for the CAH as 
calculated under Sec. 495.104(c)(4) of this subpart and 20 percentage 
points.
    (d) Incentive payments made to CAHs. (1) The amount of the incentive 
payment made to a qualifying CAH under this section represents the 
expensing and payment of the reasonable costs computed in paragraph (c) 
of this section in a single payment year and, as specified in Sec. 
413.70(a)(5) of this chapter, such payment is made in lieu of payment 
that would have been made under Sec. 413.70(a)(1) of this chapter for 
the reasonable costs of the purchase of certified EHR technology 
including depreciation and interest expenses associated with the 
acquisition.
    (2) The amount of the incentive payment made to a qualifying CAH 
under this section is paid through a prompt interim payment for the 
applicable payment year after--

[[Page 847]]

    (i) The CAH submits the necessary documentation, as specified by CMS 
or its Medicare contractors, to support the computation of the incentive 
payment amount under this section; and
    (ii) CMS or its Medicare contractor reviews such documentation and 
determines the interim amount of the incentive payment.
    (3) The interim incentive payment made under this paragraph is 
subject to a reconciliation process as specified by CMS and the final 
incentive payment as determined by CMS or its Medicare contractor is 
considered payment in full for the reasonable costs incurred for the 
purchase of certified EHR technology in a single payment year.
    (4) In no case may an incentive payment be made with respect to a 
cost reporting period beginning during a payment year before FY 2011 or 
after FY 2015 and in no case may a CAH receive an incentive payment 
under this section with respect to more than 4 consecutive payment 
years.
    (e) Reductions in payment to CAHs. For cost reporting periods 
beginning in FY 2015, if a CAH is not a qualifying CAH for a payment 
adjustment year, then the payment for inpatient services furnished by a 
CAH under Sec. 413.70(a) of this chapter is adjusted by the applicable 
percentage described in Sec. 413.70(a)(6) of this chapter unless 
otherwise exempt from such adjustment.
    (f) Administrative or judicial review. There is no administrative or 
judicial review under sections 1869 or 1878 of the Act, or otherwise, of 
the--
    (1) Methodology and standards for determining the amount of payment, 
the reasonable cost, and adjustments described in this section including 
selection of periods for determining, and making estimates or using 
proxies of, inpatient-bed-days, hospital charges, charity charges, and 
the Medicare share percentage as described in this section;
    (2) Methodology and standards for determining if a CAH is a 
qualifying CAH under this section;
    (3) Specification of EHR reporting periods, cost reporting periods, 
payment years, and fiscal years used to compute the CAH incentive 
payment as specified in this section; and
    (4) Identification of the reasonable costs used to compute the CAH 
incentive payment under paragraph (c) of this section including any 
reconciliation of the CAH incentive payment amount made under paragraph 
(d) of this section.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54158, Sept. 4, 2012]



Sec. 495.108  Posting of required information.

    (a) CMS posts, on its Internet Web site, the following information 
regarding EPs, eligible hospitals, and CAHs receiving an incentive 
payment under subparts B and C of this part:
    (1) Name.
    (2) Business addressee.
    (3) Business phone number.
    (4) Such other information as specified by CMS.
    (b) CMS posts, on its Internet Web site, the following information 
for qualifying MA organizations that receive an incentive payment under 
subpart C of this part--
    (1) The information specified in paragraph (a) of this section for 
each of the qualifying MA organization's MA plan information; and
    (2) The information specified in paragraph (a) of this section for 
each of the qualifying MA organization's MA EPs and MA-affiliated 
eligible hospitals.



Sec. 495.110  Preclusion on administrative and judicial review.

    There is no administrative or judicial review under sections 1869 or 
1878 of the Act, or otherwise, of the following:
    (a) For EPs--
    (1) The methodology and standards for determining EP incentive 
payment amounts;
    (2) The methodology and standards for determining the payment 
adjustments that apply to EPs beginning with 2015;
    (3) The methodology and standards for determining whether an EP is a 
meaningful EHR user, including--
    (i) The selection of clinical quality measures; and
    (ii) The means of demonstrating meaningful EHR use.
    (4) The methodology and standards for determining the hardship 
exception to the payment adjustments;

[[Page 848]]

    (5) The methodology and standards for determining whether an EP is 
hospital-based; and
    (6) The specification of the EHR reporting period, as well as 
whether payment will be made only once, in a single consolidated 
payment, or in periodic installments.
    (b) For eligible hospitals--
    (1) The methodology and standards for determining the incentive 
payment amounts made to eligible hospitals, including--
    (i) The estimates or proxies for determining discharges, inpatient-
bed-days, hospital charges, charity charges, and Medicare share; and
    (ii) The period used to determine such estimate or proxy;
    (2) The methodology and standards for determining the payment 
adjustments that apply to eligible hospitals beginning with FY 2015;
    (3) The methodology and standards for determining whether an 
eligible hospital is a meaningful EHR user, including--
    (i) The selection of clinical quality measures; and
    (ii) The means of demonstrating meaningful EHR use.
    (4) The methodology and standards for determining the hardship 
exception to the payment adjustments; and
    (5) The specification of the EHR reporting period, as well as 
whether payment will be made only once, in a single consolidated 
payment, or in periodic installments.



Subpart C_Requirements Specific to Medicare Advantage (MA) Organizations



Sec. 495.200  Definitions.

    As used in this subpart:
    First payment year means with respect to--
    (1) Covered professional services furnished by a qualifying MA EP, 
the first calendar year for which an incentive payment is made for such 
services under this subsection to a qualifying MA organization.
    (2) Qualifying MA-affiliated eligible hospitals, the first fiscal 
year for which an incentive payment is made for qualifying MA-affiliated 
eligible hospitals under this section to a qualifying MA organization.
    Inpatient-bed-days is defined in the same manner and is used in the 
same manner as that term is defined and used for purposes of 
implementing section 4201(a) of the American Recovery and Reinvestment 
Act of 2009 with respect to the Medicare FFS hospital EHR incentive 
program in Sec. 495.104 of this part.
    MA payment adjustment year means--
    (1) Except as provided in paragraph (2) of this definition, for 
qualifying MA organizations that receive an MA EHR incentive payment for 
at least 1 payment year, calendar years beginning with CY 2015.
    (2) For qualifying MA organizations that receive an MA EHR incentive 
payment for a qualifying MA-affiliated eligible hospital in Puerto Rico 
for at least 1 payment year, and that have not previously received an MA 
EHR incentive payment for a qualifying MA-affiliated eligible hospital 
not in Puerto Rico, calendar years beginning with CY 2022.
    (3) For MA-affiliated eligible hospitals, the applicable EHR 
reporting period for purposes of determining whether the MA organization 
is subject to a payment adjustment is the Federal fiscal year ending in 
the MA payment adjustment year.
    (4) For MA EPs, the applicable EHR reporting period for purposes of 
determining whether the MA organization is subject to a payment 
adjustment is the calendar year concurrent with the payment adjustment 
year.
    Patient care services means health care services for which payment 
would be made under, or for which payment would be based on, the fee 
schedule established under Medicare Part B if they were furnished by an 
EP to a Medicare beneficiary.
    Payment year means--
    (1) For a qualifying MA EP, a calendar year beginning with CY 2011 
and ending with CY 2016; and
    (2) For an eligible hospital, a Federal fiscal year beginning with 
FY 2011 and ending with FY 2016; and
    (3) For an eligible hospital in Puerto Rico, a Federal fiscal year 
beginning with FY 2016 and ending with FY 2021.

[[Page 849]]

    Potentially qualifying MA EPs and potentially qualifying MA-
affiliated eligible hospitals are defined for purposes of this subpart 
in Sec. 495.202(a)(4).
    Qualifying MA-affiliated eligible hospital means an eligible 
hospital under section 1886(n)(6) of the Act that is under common 
corporate governance with a qualifying MA organization, for which at 
least two thirds of the Medicare hospital discharges (or bed-days) are 
of (or for) Medicare individuals enrolled under MA plans, and that is a 
meaningful user of certified EHR technology as defined by Sec. 495.4 of 
this part. In the case of a hospital for which at least one-third of 
whose Medicare bed-days for the year are covered under Part A rather 
than Part C, payment for that payment year must only be made under 
section 1886(n) of the Act and not under this section.
    Qualifying MA EP means all of the following:
    (1) A physician (as described in section 1861(r) of the Act), 
including a doctor of medicine or osteopathy who is either of the 
following:
    (i) Employed by a qualifying MA organization.
    (ii) Employed by, or is a partner of, an entity that through a 
contract with a qualifying MA organization furnishes at least 80 percent 
of the entity's Medicare patient care services to enrollees of such 
organization.
    (2) Furnishes at least 80 percent of his or her professional 
services covered under Title XVIII to enrollees of the qualifying MA 
organization.
    (3) Furnishes, on average, at least 20 hours per week of patient 
care services to enrollees of the qualifying MA organization during the 
EHR reporting period.
    (4) Is a meaningful user of certified EHR technology in accordance 
with Sec. 495.4 of this part.
    (5) Is not a ``hospital-based EP'' (as defined in Sec. 495.4 of 
this part) and in determining whether 90 percent or more of his or her 
covered professional services were furnished in a hospital setting, only 
covered professional services furnished to MA plan enrollees of the 
qualifying MA organization, in lieu of FFS patients, will be considered.
    Qualifying MA organization means a MA organization that is organized 
as a health maintenance organization (HMO) as defined in section 
2791(b)(3) of the Public Health Service (PHS) Act which includes a 
Federally qualified HMO, an organization recognized as an HMO under 
State law, or a similar organization regulated for solvency under State 
law in the same manner and to the same extent as an HMO.
    Second, third, fourth, and fifth payment year means with respect to 
incentive payments for qualifying--
    (1) MA EPs to a qualifying MA organization, each successive calendar 
year immediately following the first payment year for the qualifying MA 
organization. The first payment year and each successive year 
immediately following the first payment year, for the qualifying MA 
organizations, through 2016, is the same for all qualifying MA EPs with 
respect to any specific qualifying MA organization.
    (2) MA-affiliated eligible hospitals to a qualifying MA 
organization, each successive fiscal year immediately following the 
first payment year for the qualifying MA organization.
    Under common corporate governance means that a qualifying MA 
organization and a qualifying MA-affiliated eligible hospital have a 
common parent corporation, that one is a subsidiary of the other, or 
that the organization and the hospital have a common board of directors.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54158, Sept. 4, 2012; 
83 FR 41711, Aug. 17, 2018]



Sec. 495.202  Identification of qualifying MA organizations, MA-EPs 
and MA-affiliated eligible hospitals.

    (a) Identification of qualifying MA organizations. (1) Beginning 
with bids due in June 2011 (for plan year 2012), MA organizations 
seeking reimbursement for qualifying MA EPs and qualifying MA-affiliated 
eligible hospitals under the MA EHR incentive program are required to 
identify themselves to CMS in a form and manner specified by CMS, as 
part of submissions of initial bids under section 1854(a)(1)(A) of the 
Act.
    (2) Qualifying MA organizations offering MA HMO plans, absent 
evidence to the contrary, are deemed to meet the definition of HMO in 42 
U.S.C.

[[Page 850]]

300gg-91(b)(3)--section 2791(b)(3) of the PHS Act.
    (3) Qualifying MA organizations offering MA plan types other than 
HMOs, must attest to the fact that they meet the definition of HMO in 42 
U.S.C. 300gg-91(b)(3)--section 2791(b)(3) of the PHS Act.
    (4) Beginning with bids due in June 2014 (for plan year 2015), all 
MA organizations with potentially qualifying MA EPs or potentially 
qualifying MA-affiliated eligible hospitals under the MA EHR incentive 
program must identify themselves to CMS in a form and manner specified 
by CMS, as part of submissions of initial bids under section 
1854(a)(1)(A) of the Act. ``Potentially qualifying MA EPs'' and 
``potentially qualifying MA-affiliated eligible hospitals'' are those 
EPs and hospitals that meet the respective definitions of ``qualifying 
MA EP'' and ``qualifying MA-affiliated eligible hospital'' in Sec. 
495.200 but who (or which) are not meaningful users of certified EHR 
technology.
    (b) Identification of qualifying MA EPs and qualifying MA-affiliated 
eligible hospitals. (1) A qualifying MA organization, as part of its 
initial bid starting with plan year 2012, must make a preliminary 
identification of MA EPs and MA-affiliated eligible hospitals that the 
MA organization believes will be qualifying MA EPs and MA-affiliated 
eligible hospitals for which the organization is seeking incentive 
payments for the current plan year.
    (2) A qualifying MA organization must provide CMS with the following 
for each MA EP or eligible hospital when reporting under either 
paragraph (b)(1) or (4) of this section:
    (i) The MA EP's or MA-affiliated eligible hospital's name.
    (ii) The address of the MA EP's practice or MA-affiliated eligible 
hospital's location.
    (iii) NPI or CCN.
    (iv) An attestation by MA organization specifying that the MA EP or 
MA-affiliated eligible hospital meets the eligibility criteria.
    (3) When reporting under either paragraph (b)(1) or (4) of this 
section for purposes of receiving an incentive payment, a qualifying MA 
organization must also indicate whether more than 50 percent of the 
covered Medicare professional services being furnished by a qualifying 
MA EP to MA plan enrollees of the MA organization are being furnished in 
a designated geographic HPSA (as defined in Sec. 495.100 of this part).
    (4) Final identification of qualifying and potentially qualifying, 
as applicable, MA EPs and MA-affiliated eligible hospitals must be made 
within 2 months of the close of the payment year or the EHR reporting 
period that applies to the payment adjustment year as defined in Sec. 
495.200.
    (5) Beginning plan year 2015 and for subsequent plan years, all 
qualifying MA organizations, as part of their initial bids in June for 
the following plan year must--
    (i) Identify all MA EPs and MA-affiliated eligible hospitals of the 
MA organization that the MA organization believes will be either 
qualifying or potentially qualifying;
    (ii) Include information specified in paragraph (b)(2)(i) through 
(iii) of this section for each professional or hospital; and
    (iii) Include an attestation that each professional and hospital 
either meets or does not meet the EHR incentive payment eligibility 
criteria.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54158, Sept. 4, 2012]



Sec. 495.204  Incentive payments to qualifying MA organizations for
qualifying MA-EPs and qualifying MA-affiliated eligible hospitals.

    (a) General rule. A qualifying MA organization receives an incentive 
payment for its qualifying MA-EPs and its qualifying MA-eligible 
hospitals. The incentive payment amount paid to a qualifying MA 
organization for a--
    (1) Qualifying MA-EP is the amount determined under paragraph (b) of 
this section; and
    (2) Qualifying MA-eligible hospital is the amount determined under 
paragraph (c) of this section.
    (b) Amount payable to qualifying MA organization for qualifying MA 
EPs. (1) CMS substitutes an amount determined to be equivalent to the 
amount computed under Sec. 495.102 of this part.
    (2) The qualifying MA organization must report to CMS within 2 
months of

[[Page 851]]

the close of the calendar year, the aggregate annual amount of revenue 
attributable to providing services that would otherwise be covered as 
professional services under Part B received by each qualifying MA EP for 
enrollees in MA plans of the MA organization in the payment year.
    (3) CMS calculates the incentive amount for the MA organization for 
each qualifying MA EP as an amount equal to 75 percent of the reported 
annual revenue specified in paragraph (b)(2) of this section, up to the 
maximum amounts specified under section 1848(o)(1)(B) of the Act.
    (4) CMS requires the qualifying MA organization to develop a 
methodological proposal for estimating the portion of each qualifying MA 
EP's salary or revenue attributable to providing services that would 
otherwise be covered as professional services under Part B to MA plan 
enrollees of the MA organization in the payment year. The methodological 
proposal--
    (i) Must be approved by CMS; and
    (ii) May include an additional amount related to overhead, where 
appropriate, estimated to account for the MA-enrollee related Part B 
practice costs of the qualifying MA EP.
    (iii) Methodological proposals must be submitted to CMS by June of 
the payment year and must be auditable by an independent third-party. 
CMS will review and approve or disapprove such proposals in a timely 
manner.
    (5) For qualifying MA EPs who are not salaried, qualifying MA 
organizations may obtain attestations from such qualifying MA EPs (or 
from entities that the MA EPs are employed by or with which they have a 
partnership interest) as to the amount of compensation received by such 
EPs for MA plan enrollees of the MA organization. The organizations may 
submit to CMS compensation information for each such MA EP based on such 
attestations.
    (6) For qualifying MA EPs who are not salaried, qualified MA 
organizations may have qualifying MA EPs (or from entities that the MA 
EPs are employed by or with which they have a partnership interest) send 
MA organization compensation information directly to CMS. CMS will use 
the information provided in this subparagraph or paragraph (b)(5) of 
this section for no other purpose than to compute the amount of EHR 
incentive payment due the MA organization.
    (c) Amount payable to qualifying MA organization for qualifying MA-
affiliated eligible hospitals. (1)(i) CMS substitutes an amount 
determined to be equivalent to the amount computed under Sec. 495.104, 
to the extent data are not available to compute payments for qualifying 
MA-affiliated eligible hospitals under the Medicare FFS EHR hospital 
incentive program.
    (ii) CMS uses the same methodology and defines ``inpatient-bed-
days''and other terms as used under the Medicare FFS EHR hospital 
incentive program in Sec. 495.104 of this part in computing amounts due 
qualifying MA organizations for MA-affiliated eligible hospitals.
    (2) To the extent data are available, qualifying MA organizations 
must receive hospital incentive payments through their affiliated 
hospitals under the Medicare FFS EHR hospital incentive program, rather 
than through the MA EHR hospital incentive program.
    (d) Payment to qualifying MA organizations. CMS makes payment to 
qualifying MA organizations for qualifying MA EPs only under the MA EHR 
incentive program and not under the Medicare FFS EHR incentive program 
to the extent an EP has earned less than the maximum incentive payment 
for the same period under the Medicare FFS EHR incentive program.
    (e) Potential increase in incentive payment for furnishing services 
in a geographic HPSA. In the case of a qualifying MA EP who furnishes 
more than 50 percent of his or her covered professional services to MA 
plan enrollees of the qualifying MA organization during a payment year 
in a geographic HPSA, the maximum amounts referred to in paragraph 
(b)(3) of this section are increased by 10 percent.
    (f) Payment review under MA. To ensure the accuracy of the incentive 
payments, CMS conducts selected compliance reviews of qualifying MA 
organizations to ensure that EPs and eligible hospitals for which such 
qualifying organizations received incentive payments were meaningful EHR 
users in

[[Page 852]]

accordance with Sec. 422.504 of this chapter.
    (1) The reviews include validation of the status of the organization 
as a qualifying MA organization, verification of meaningful use and 
review of data used to calculate incentive payments.
    (2) MA organizations are required to maintain evidence of their 
qualification to receive incentive payments and the data necessary to 
accurately calculate incentive payments.
    (3) Documents and records must be maintained for 6 years from the 
date such payments are made with respect to a given payment year.
    (4) Payments that result from incorrect or fraudulent attestations, 
cost data, or any other submission required to establish eligibility or 
to qualify for such payment, will be recouped by CMS from the MA 
organization.
    (5) If an MA EP, or entity that employs an MA EP, or in which an MA 
EP has a partnership interest, MA-affiliated eligible hospital, or other 
party contracting with the MA organization, fails to comply with an 
audit request to produce applicable documents or data, CMS recoups all 
or a portion of the incentive payment, based on the lack of applicable 
documents or data.
    (g) Coordination of payment with FFS or Medicaid EHR incentive 
programs. (1) If, after payment is made to an MA organization for an MA 
EP, it is determined that the MA EP is eligible for the full incentive 
payment under the Medicare FFS EHR Incentive Program or has received a 
payment under the Medicaid EHR Incentive Program, CMS recoups amounts 
applicable to the given MA EP from the MA organization's monthly MA 
payment, or otherwise recoups the applicable amounts.
    (2) If, after payment is made to an MA organization for an MA-
affiliated eligible hospital, it is determined that the hospital is 
ineligible for the incentive payment under the MA EHR Incentive Program, 
or has received a payment under the Medicare FFS EHR Incentive Program, 
or if it is determined that all or part of the payment should not have 
been made on behalf of the MA-affiliated eligible hospital, CMS recoups 
amounts applicable to the given MA-affiliated eligible hospital from the 
MA organization's monthly MA payment, or otherwise recoups the 
applicable amounts.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54158, Sept. 4, 2012]



Sec. 495.206  Timeframe for payment to qualifying MA organizations.

    (a) CMS makes payment to qualifying MA organizations for qualifying 
MA EPs under the MA EHR incentive program after computing incentive 
payments due under the Medicare FFS EHR incentive program according to 
Sec. 495.102.
    (b) Payments to qualifying MA organizations for qualifying MA-
affiliated eligible hospitals under common corporate governance are made 
under the Medicare FFS EHR incentive program, following the timeline in 
specified in Sec. 495.104 of this part. To the extent sufficient data 
do not exist to pay qualifying MA-affiliated eligible hospitals under 
common corporate governance under the Medicare FFS EHR incentive 
program, payment is made under the MA EHR incentive program, following 
the same timeline in Sec. 495.104 of this part.



Sec. 495.208  Avoiding duplicate payment.

    (a) CMS requires a qualifying MA organization that registers MA EPs 
for the purpose of participating in the MA EHR Incentive Program to 
notify each of the MA EPs for which it is claiming an incentive payment 
that the MA organization intends to claim, or has claimed, the MA EP for 
the current plan year under the MA EHR Incentive Program.
    (b) The notice must make clear that the MA EP may still directly 
receive an EHR incentive payment if the MA EP is entitled to a full 
incentive payment under the FFS portion of the EHR Incentive Program, or 
if the MA EP registered to participate under the Medicaid portion of the 
EHR Incentive Program and is entitled to payment under that program--in 
both of which cases no payment would be made for the EP under the MA EHR 
incentive program.
    (c) An attestation by the qualifying MA organization that the 
qualifying MA organization provided notice to its

[[Page 853]]

MA EPs in accordance with this section must be required at the time that 
meaningful use attestations are due with respect to MA EPs for the 
payment year.
    (d) Unless a qualifying MA EP is entitled to a maximum payment for a 
year under the Medicare FFS EHR incentive program, payment for such an 
individual is only made under the MA EHR incentive program to a 
qualifying MA organization.
    (e) Payment to qualifying MA organizations for a qualifying MA-
affiliated eligible hospital under common governance only occurs under 
the MA EHR incentive program to the extent that sufficient data does not 
exist to pay such hospital under the Medicare FFS hospital incentive 
program under Sec. 495.104 of this part. In no event are EHR incentive 
payments made for a hospital for a payment year under this section to 
the extent they have been made for the same hospital for the same 
payment year under Sec. 495.104 of this part.
    (f) Each qualifying MA organization must ensure that all potentially 
qualifying MA EPs are enumerated through the NPI system and that other 
identifying information required under Sec. 495.202(b) is provided to 
CMS.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54159, Sept. 4, 2012]



Sec. 495.210  Meaningful EHR user attestation.

    (a) Qualifying MA organizations are required to attest, in a form 
and manner specified by CMS, that each qualifying MA EP and qualifying 
MA-affiliated eligible hospitals is a meaningful EHR user.
    (b) Qualifying MA organizations are required to attest within 2 
months after the close of a calendar year whether each qualifying MA EP 
is a meaningful EHR user.
    (c) Qualifying MA organizations are required to attest within 2 
months after close of the FY whether each qualifying MA-affiliated 
eligible hospital is a meaningful EHR user.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54159, Sept. 4, 2012]



Sec. 495.211  Payment adjustments effective for 2015 and subsequent
MA payment years with respect to MA EPs and MA-affiliated eligible 
hospitals.

    (a) In general. Beginning for MA payment adjustment year 2015, 
payment adjustments set forth in this section are made to prospective 
payments (issued under section 1853(a)(1)(A) of the Act) of qualifying 
MA organizations that previously received incentive payments under the 
MA EHR Incentive Program, if all or a portion of the MA-EPs and MA-
affiliated eligible hospitals that would meet the definition of 
qualifying MA-EPs or qualifying MA-affiliated eligible hospitals (but 
for their demonstration of meaningful use) are not meaningful EHR users.
    (b) Adjustment based on payment adjustment year. The payment 
adjustment is calculated based on the payment adjustment year.
    (c) Separate application of adjustments for MA EPs and MA-affiliated 
eligible hospitals. The payment adjustments identified in paragraphs (d) 
and (e) of this section are applied separately. Paragraph (d) of this 
section applies only to qualifying MA organizations that received 
payment for any MA payment year for qualifying MA EPs under Sec. 
495.204. Paragraph (e) of this section applies only to qualifying MA 
organizations that received payment for any MA payment year for 
qualifying MA-affiliated eligible hospitals under Sec. 495.204.
    (d) Payment adjustments effective for 2015 and subsequent years with 
respect to MA EPs. (1) For payment adjustment year 2015, and subsequent 
payment adjustment years, if a qualifying MA EP is not a meaningful EHR 
user during the payment adjustment year, CMS--
    (i) Determines a payment adjustment based on data from the payment 
adjustment year; and
    (ii) Collects the payment adjustment owed by adjusting a subsequent 
year's prospective payment or payments (issued under section 
1853(a)(1)(A) of the Act), or by otherwise collecting the payment 
adjustment, if, in the year of collection, the MA organization does not 
have an MA contract with CMS.

[[Page 854]]

    (2) Beginning for payment adjustment year 2015, a qualifying MA 
organization that previously received incentive payments must, for each 
payment adjustment year, report to CMS the following:

[the total number of potentially qualifying MA EPs]/[(the total number 
of potentially qualifying MA EPs) + (the total number of qualifying MA 
EPs)].

    (3) The monthly prospective payment amount paid under section 
1853(a)(1)(A) of the Act for the payment adjustment year is adjusted by 
the product of--
    (i) The percent calculated in accordance with paragraph (d)(2) of 
this section;
    (ii) The Medicare Physician Expenditure Proportion percent, which is 
CMS's estimate of proportion of expenditures under Parts A and B that 
are not attributable to Part C that are attributable to expenditures for 
physicians' services, adjusted for the proportion of expenditures that 
are provided by EPs that are neither qualifying nor potentially 
qualifying MA EPs with respect to a qualifying MA organization; and
    (iii) The applicable percent identified in paragraph (d)(4) of this 
section.
    (4) Applicable percent. The applicable percent is as follows:
    (i) For 2015, 1 percent;
    (ii) For 2016, 2 percent;
    (iii) For 2017, 3 percent.
    (iv) For 2018, 3 percent, except, in the case described in paragraph 
(d)(4)(vi) of this section, 4 percent.
    (v) For 2019 and each subsequent year, 3 percent, except, in the 
case described in paragraph (d)(4)(vi) of this section, the percent from 
the prior year plus 1 percent. In no case will the applicable percent be 
higher than 5 percent.
    (vi) Beginning with payment adjustment year 2018, if the percentage 
in paragraph (d)(2) of this section is more than 25 percent, the 
applicable percent is increased in accordance with paragraphs (d)(4)(iv) 
and (v) of this section.
    (e) Payment adjustments effective for 2015 and subsequent years with 
respect to MA-affiliated eligible hospitals. (1)(i) The payment 
adjustment set forth in this paragraph (e) applies if a qualifying MA 
organization that previously received an incentive payment (or a 
potentially qualifying MA-affiliated eligible hospital on behalf of its 
qualifying MA organization) attests that a qualifying MA-affiliated 
eligible hospital is not a meaningful EHR user for a payment adjustment 
year.
    (ii) The payment adjustment is calculated by multiplying the 
qualifying MA organization's monthly prospective payment for the payment 
adjustment year under section 1853(a)(1)(A) of the Act by the percent 
set forth in paragraph (e)(2) of this section.
    (2) The percent set forth in this paragraph (e) is the product of--
    (i) The percentage point reduction to the applicable percentage 
increase in the market basket index for the relevant Federal fiscal year 
as a result of Sec. 412.64(d)(3) of this chapter;
    (ii) The Medicare Hospital Expenditure Proportion percent specified 
in paragraph (e)(3) of this section; and
    (iii) The percent of qualifying and potentially qualifying MA-
affiliated eligible hospitals that are not meaningful EHR users. 
Qualifying MA organizations are required to report to CMS

[the number of potentially qualifying MA-affiliated eligible hospitals] 
/ [(the total number of potentially qualifying MA-affiliated eligible 
hospitals) + (the total number of qualifying MA-affiliated eligible 
hospitals)].

    (3) The Medicare Hospital Expenditure Proportion for a year is the 
Secretary's estimate of expenditures under Parts A and B that are not 
attributable to Part C, that are attributable to expenditures for 
inpatient hospital services, adjusted for the proportion of expenditures 
that are provided by hospitals that are neither qualifying nor 
potentially qualifying MA-affiliated eligible hospitals with respect to 
a qualifying MA organization.
    (4) For MA payment adjustment years prior to 2022, subsection (d) 
Puerto Rico hospitals are neither potentially qualifying MA-affiliated 
eligible hospitals nor qualifying MA-affiliated eligible hospitals for 
purposes of applying the payment adjustments under paragraph (e) of this 
section.

[77 FR 54159, Sept. 4, 2012, as amended at 83 FR 41711, Aug. 17, 2018]

[[Page 855]]



Sec. 495.212  Limitation on review.

    (a) There is no administrative or judicial review under section 1869 
or 1878 of the Act, or otherwise of the methodology and standards for 
determining payment amounts and payment adjustments under the MA EHR EP 
incentive program. This includes provisions related to duplication of 
payment avoidance and rules developed related to the fixed schedule for 
application of limitation on incentive payments for all qualifying MA 
EPs related to a specific qualifying MA organization. It also includes 
the methodology and standards developed for determining qualifying MA 
EPs and the methodology and standards for determining a meaningful EHR 
user, including the means of demonstrating meaningful use and the 
selection of measures.
    (b) There is no administrative or judicial review under sections 
1869 or 1878 of the Act, or otherwise, of the methodology and standards 
for determining payment amounts and payment adjustments under the MA EHR 
hospital incentive program. This includes provisions related to 
duplication of payment avoidance. It also includes the methodology and 
standards developed for determining qualifying MA-affiliated eligible 
hospitals and the methodology and standards for determining a meaningful 
EHR user, including the means of demonstrating meaningful use and the 
selection of measures.



         Subpart D_Requirements Specific to the Medicaid Program



Sec. 495.300  Basis and purpose.

    This subpart implements section 4201 of the American Reinvestment 
and Recovery Act of 2009 and sections 1903(a)(3)(F) and 1903(t) of the 
Act, which authorize States, at their option, to provide for incentive 
payments to Medicaid providers for adopting, implementing, or upgrading 
certified EHR technology or for meaningful use of such technology. This 
subpart also provides enhanced Federal financial participation (FFP) to 
States to administer these incentive payments.



Sec. 495.302  Definitions.

    As used in this subpart--
    Acceptance documents mean written evidence of satisfactory 
completion of an approved phase of work or contract and acceptance 
thereof by the State agency.
    Acquisition means to acquire health information technology (HIT) 
equipment or services for the purpose of implementation and 
administration under this part from commercial sources or from State or 
local government resources.
    Acute care hospital means a health care facility--
    (1) Where the average length of patient stay is 25 days or fewer; 
and
    (2) With a CMS certification number (previously known as the 
Medicare provider number) that has the last four digits in the series 
0001-0879 or 1300-1399
    Adopt, implement or upgrade means--
    (1) Acquire, purchase, or secure access to certified EHR technology 
capable of meeting meaningful use requirements;
    (2) Install or commence utilization of certified EHR technology 
capable of meeting meaningful use requirements; or
    (3) Expand the available functionality of certified EHR technology 
capable of meeting meaningful use requirements at the practice site, 
including staffing, maintenance, and training, or upgrade from existing 
EHR technology to certified EHR technology per the ONC EHR certification 
criteria.
    (4) For payment year 2014, the references to ``certified EHR 
technology'' in paragraphs (1) through (3) of this definition are deemed 
to be references to paragraph (2) of the definition of ``Certified EHR 
Technology'' under 45 CFR 170.102 (that is, the definition of 
``Certified EHR Technology'' for FY and CY 2015 and subsequent years).
    Children's hospital means a separately certified children's 
hospital, either freestanding or hospital-within-hospital that--
    (1) Has a CMS certification number (CCN), (previously known as the 
Medicare provider number), that has the last 4 digits in the series 
3300-3399; or
    (2) Does not have a CCN but has been provided an alternative number 
by CMS for purposes of enrollment in the

[[Page 856]]

Medicaid EHR Incentive Program as a children's hospital and;
    (3) Predominantly treats individuals under 21 years of age.
    Entities promoting the adoption of certified electronic health 
record technology means the State-designated entities that are promoting 
the adoption of certified EHR technology by enabling oversight of the 
business, operational and legal issues involved in the adoption and 
implementation of certified EHR technology or by enabling the exchange 
and use of electronic clinical and administrative data between 
participating providers, in a secure manner, including maintaining the 
physical and organizational relationship integral to the adoption of 
certified EHR technology by eligible providers.
    Health information technology planning advance planning document 
(HIT PAPD) means a plan of action that requests FFP and approval to 
accomplish the planning necessary for a State agency to determine the 
need for and plan the acquisition of HIT equipment or services or both 
and to acquire information necessary to prepare a HIT implementation 
advanced planning document or request for proposal to implement the 
State Medicaid HIT plan.
    HIT implementation advance planning document (HIT IAPD) means a plan 
of action that requests FFP and approval to acquire and implement the 
proposed State Medicaid HIT plan services or equipment or both.
    Medicaid information technology architecture (MITA) is both an 
initiative and a framework. It is a national framework to support 
improved systems development and health care management for the Medicaid 
enterprise. It is an initiative to establish national guidelines for 
technologies and processes that enable improved program administration 
for the Medicaid enterprise. The MITA initiative includes an 
architecture framework, models, processes, and planning guidelines for 
enabling State Medicaid enterprises to meet common objectives with the 
framework while supporting unique local needs.
    Medicaid management information system (MMIS) means a mechanized 
claims processing and information retrieval system--referred to as 
Medicaid Management Information Systems (MMIS)--that meets specified 
requirements and that the Department has found (among other things) is 
compatible with the claims processing and information retrieval systems 
used in the administration of the Medicare program. The objectives of 
the MMIS are to include claims processing and retrieval of utilization 
and management information necessary for program administration and 
audit and must coordinate with other mechanized systems and subsystems 
that perform other functions, such as eligibility determination.
    Needy individuals mean individuals that meet one of following:
    (1) Received medical assistance from Medicaid or the Children's 
Health Insurance Program. (or a Medicaid or CHIP demonstration project 
approved under section 1115 of the Act).
    (2) Were furnished uncompensated care by the provider.
    (3) Were furnished services at either no cost or reduced cost based 
on a sliding scale determined by the individuals' ability to pay.
    Patient volume means the minimum participation threshold (as 
described at Sec. 495.304(c) through (e)) that is estimated through a 
numerator and denominator, consistent with the SMHP, and that meets the 
requirements of Sec. 495.306.
    Practices predominantly means an EP for whom the clinical location 
for over 50 percent of his or her total patient encounters over a period 
of 6 months (within the most recent calendar year or, as an optional 
State alternative beginning for payment year 2013, within the 12-month 
period preceding attestation)occurs at a federally qualified health 
center or rural health clinic.
    Service oriented architecture or service component based 
architecture means organizing and developing information technology 
capabilities as collaborating services that interact with each other 
based on open standards.
    State Medicaid health information technology plan (SMHP) means a 
document that describes the State's current and future HIT activities.
    State self-assessment means a process that a State uses to review 
its strategic goals and objectives, measure its

[[Page 857]]

current business processes and capabilities against the (MITA) business 
capabilities and ultimately develops target capabilities to transform 
its Medicaid enterprise to be consistent with the MITA principles.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54160, Sept. 4, 2012; 
79 FR 52933, Sept. 4, 2014]



Sec. 495.304  Medicaid provider scope and eligibility.

    (a) General rule. The following Medicaid providers are eligible to 
participate in the HIT incentives program:
    (1) Medicaid EPs.
    (2) Acute care hospitals.
    (3) Children's hospitals.
    (b) Medicaid EP. The Medicaid professional eligible for an EHR 
incentive payment is limited to the following when consistent with the 
scope of practice regulations, as applicable for each professional 
(Sec. Sec. 440.50, 440.60, 440.100; Sec. Sec. 440.165, and 440.166):
    (1) A physician.
    (2) A dentist.
    (3) A certified nurse-midwife.
    (4) A nurse practitioner.
    (5) A physician assistant practicing in a Federally qualified health 
center (FQHC) led by a physician assistant or a rural health clinic 
(RHC), that is so led by a physician assistant.
    (c) Additional requirements for the Medicaid EP. To qualify for an 
EHR incentive payment, a Medicaid EP must, for each year for which the 
EP seeks an EHR incentive payment, not be hospital-based as defined at 
Sec. 495.4 of this subpart, and meet one of the following criteria:
    (1) Have a minimum 30 percent patient volume attributable to 
individuals enrolled in a Medicaid program.
    (2) Have a minimum 20 percent patient volume attributable to 
individuals enrolled in a Medicaid program, and be a pediatrician.
    (3) Practice predominantly in a FQHC or RHC and have a minimum 30 
percent patient volume attributable to needy individuals, as defined at 
Sec. 495.302.
    (d) Exception. The hospital-based exclusion in paragraph (c) of this 
section does not apply to the Medicaid-EP qualifying based on practicing 
predominantly at a FQHC or RHC.
    (e) Additional requirement for the eligible hospital. To be eligible 
for an EHR incentive payment for each year for which the eligible 
hospital seeks an EHR incentive payment, the eligible hospital must meet 
the following criteria:
    (1) An acute care hospital must have at least a 10 percent Medicaid 
patient volume for each year for which the hospital seeks an EHR 
incentive payment.
    (2) A children's hospital is exempt from meeting a patient volume 
threshold.
    (f) Further patient volume requirements for the Medicaid EP. For 
payment year 2013 and all subsequent payment years, at least one 
clinical location used in the calculation of patient volume must have 
Certified EHR Technology--
    (1) During the payment year for which the EP attests to having 
adopted, implemented or upgraded Certified EHR Technology (for the first 
payment year); or
    (2) During the payment year for which the EP attests it is a 
meaningful EHR user.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54160, Sept. 4, 2012]



Sec. 495.306  Establishing patient volume.

    (a) General rule. A Medicaid provider must annually meet patient 
volume requirements of Sec. 495.304, as these requirements are 
established through the State's SMHP in accordance with the remainder of 
this section.
    (b) State option(s) through SMHP. (1) A State must submit through 
the SMHP the option or options it has selected for measuring patient 
volume.
    (2)(i) A State must select the method described in either paragraph 
(c) or paragraph (d) of this section (or both methods).
    (ii) Under paragraphs (c)(1)(i), (c)(2)(i), (c)(3)(i), (d)(1)(i), 
and (d)(2)(i) of this section, States may choose whether to allow 
eligible providers to calculate total Medicaid or total needy individual 
patient encounters in any representative continuous 90-day period in the 
12 months preceding the EP or eligible hospital's attestation or based 
upon a representative, continuous 90-day period in the calendar year 
preceding the payment year for which the EP or eligible hospital is 
attesting.

[[Page 858]]

    (3) In addition, or as an alternative to the method selected in 
paragraph (b)(2) of this section, a State may select the method 
described in paragraph (g) of this section.
    (c) Methodology, patient encounter--(1) EPs. To calculate Medicaid 
patient volume, an EP must divide:
    (i) The total Medicaid patient encounters in any representative, 
continuous 90-day period in the calendar year preceding the EP's payment 
year, or in the 12 months before the EP's attestation; by
    (ii) The total patient encounters in the same 90-day period.
    (2) Eligible hospitals. To calculate Medicaid patient volume, an 
eligible hospital must divide--
    (i) The total Medicaid encounters in any representative, continuous 
90-day period in the fiscal year preceding the hospitals' payment year 
or in the 12 months before the hospital's attestation; by
    (ii) The total encounters in the same 90-day period.
    (3) Needy individual patient volume. To calculate needy individual 
patient volume, an EP must divide--
    (i) The total needy individual patient encounters in any 
representative, continuous 90-day period in the calendar year preceding 
the EP's payment year, or in the 12 months before the EP's attestation; 
by
    (ii) The total patient encounters in the same 90-day period.
    (d) Methodology, patient panel--(1) EPs. To calculate Medicaid 
patient volume, an EP must divide:
    (i)(A) The total Medicaid patients assigned to the EP's panel in any 
representative, continuous 90-day period in either the calendar year 
preceding the EP's payment year, or the 12 months before the EP's 
attestation when at least one Medicaid encounter took place with the 
individual in the 24 months before the beginning of the 90-day period; 
plus
    (B) Unduplicated Medicaid encounters in the same 90-day period; by
    (ii)(A) The total patients assigned to the provider in that same 90-
day period with at least one encounter taking place with the patient 
during the 24 months before the beginning of the 90-day period; plus
    (B) All unduplicated patient encounters in the same 90-day period.
    (2) Needy individual patient volume. To calculate needy individual 
patient volume an EP must divide--
    (i)(A) The total Needy Individual patients assigned to the EP's 
panel in any representative, continuous 90-day period in the either the 
calendar year preceding the EP's payment year, or the 12 months before 
the EP's attestation when at least one Needy Individual encounter took 
place with the individual in the 24 months before the beginning of the 
same 90-day period; plus
    (B) Unduplicated Needy Individual encounters in the same 90-day 
period, by
    (ii)(A) The total patients assigned to the provider in that same 90-
day period with at least one encounter taking place with the patient 
during the 24 months before the beginning of the 90-day period, plus
    (B) All unduplicated patient encounters in the same 90-day period.
    (e) For purposes of this section, the following rules apply:
    (1) A Medicaid encounter means services rendered to an individual on 
any one day where:
    (i) Medicaid (or a Medicaid demonstration project approved under 
section 1115 of the Act) paid for part or all of the service.
    (ii) Medicaid (or a Medicaid demonstration project approved under 
section 1115 of the Act) paid all or part of the individual's premiums, 
co-payments, and cost-sharing.
    (iii) The individual was enrolled in a Medicaid program (or a 
Medicaid demonstration project approved under section 1115 of the Act) 
at the time the billable service was provided.
    (2) For purposes of calculating hospital patient volume, both of the 
following definitions in paragraphs (e)(2)(i) and (e)(2)(ii) of this 
section may apply:
    (i) A Medicaid encounter means services rendered to an individual 
per inpatient discharge when any of the following occur:
    (A) Medicaid (or a Medicaid demonstration project approved under 
section 1115 of the Act) paid for part or all of the service.

[[Page 859]]

    (B) Medicaid (or a Medicaid demonstration project approved under 
section 1115 of the Act) paid all or part of the individual's premiums, 
co-payments, and/or cost-sharing.
    (C) The individual was enrolled in a Medicaid program (or a Medicaid 
demonstration project approved under section 1115 of the Act) at the 
time the billable service was provided.
    (ii) A Medicaid encounter means services rendered in an emergency 
department on any 1 day if any of the following occur:
    (A) Medicaid (or a Medicaid demonstration project approved under 
section 1115 of the Act) paid for part or all of the service.
    (B) Medicaid (or a Medicaid demonstration project approved under 
section 1115 of the Act) paid all or part of the individual's premiums, 
co-payments, and cost-sharing.
    (C) The individual was enrolled in a Medicaid program (or a Medicaid 
demonstration project approved under section 1115 of the Act) at the 
time the billable service was provided.
    (3) For purposes of calculating needy individual patient volume, a 
needy patient encounter means services rendered to an individual on any 
1 day if any of the following occur:
    (i) Medicaid or CHIP (or a Medicaid or CHIP demonstration project 
approved under section 1115 of the Act) paid for part or all of the 
service.
    (ii) Medicaid or CHIP (or a Medicaid or CHIP demonstration project 
approved under section 1115 of the Act) paid all or part of the 
individual's premiums, co-payments, or cost-sharing.
    (iii) The individual was enrolled in a Medicaid program (or a 
Medicaid demonstration project approved under section 1115 of the Act) 
at the time the billable service was provided.
    (iv) The services were furnished at no cost; and calculated 
consistent with Sec. 495.310(h).
    (v) The services were paid for at a reduced cost based on a sliding 
scale determined by the individual's ability to pay.
    (f) Exception. A children's hospital is not required to meet 
Medicaid patient volume requirements.
    (g) Establishing an alternative methodology. A State may submit to 
CMS for review and approval through the SMHP an alternative from the 
options included in paragraphs (c) and (d) of this section, so long as 
it meets the following requirements:
    (1) It is submitted consistent with all rules governing the SMHP at 
Sec. 495.332.
    (2) Has an auditable data source.
    (3) Has received input from the relevant stakeholder group.
    (4) It does not result, in the aggregate, in fewer providers 
becoming eligible than the methodologies in either paragraphs (c) and 
(d) of this section.
    (h) Group practices. Clinics or group practices will be permitted to 
calculate patient volume at the group practice/clinic level, but only in 
accordance with all of the following limitations:
    (1) The clinic or group practice's patient volume is appropriate as 
a patient volume methodology calculation for the EP.
    (2) There is an auditable data source to support the clinic's or 
group practice's patient volume determination.
    (3) All EPs in the group practice or clinic must use the same 
methodology for the payment year.
    (4) The clinic or group practice uses the entire practice or 
clinic's patient volume and does not limit patient volume in any way.
    (5) If an EP works inside and outside of the clinic or practice, 
then the patient volume calculation includes only those encounters 
associated with the clinic or group practice, and not the EP's outside 
encounters.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54160, Sept. 4, 2012]



Sec. 495.308  Net average allowable costs as the basis for determining
the incentive payment.

    (a) The first year of payment. (1) The incentive is intended to 
offset the costs associated with the initial adoption, implementation or 
upgrade of certified electronic health records technology.
    (2) The maximum net average allowable costs for the first year are 
$25,000.
    (b) Subsequent payment years. (1) The incentive is intended to 
offset maintenance and operation of certified EHR technology.
    (2) The maximum net average allowable costs for each subsequent year 
are $10,000.

[[Page 860]]



Sec. 495.310  Medicaid provider incentive payments.

    (a) Rules for Medicaid EPs. The Medicaid EP's incentive payments are 
subject to all of the following limitations:
    (1) First payment year. (i) For the first payment year, payment 
under this subpart may not exceed 85 percent of the maximum threshold of 
$25,000, which equals $21,250.
    (ii) [Reserved]
    (iii) An EP may not begin receiving payments any later than CY 2016.
    (2) Subsequent annual payment years.
    (i) For subsequent payment years, payment may not exceed 85 percent 
of the maximum threshold of $10,000, which equals $8,500.
    (ii) [Reserved]
    (iii) Payments after the first payment year may continue for a 
maximum of 5 years.
    (iv) Medicaid EPs may receive payments on a non-consecutive, annual 
basis.
    (v) No payments may be made after CY 2021.
    (3) Maximum incentives. In no case may a Medicaid EP participate for 
more than a total of 6 years, and in no case will the maximum incentive 
over a 6-year period exceed $63,750.
    (4) Limitation. For a Medicaid EP who is a pediatrician described in 
paragraph (b) of this section payment is limited as follows:
    (i) The maximum payment in the first payment year is further reduced 
by two-thirds, which equals $14,167.
    (ii) The maximum payment in subsequent payment years is further 
reduced by two-thirds, which equals $5,667.
    (iii) In no case will the maximum incentive payment to a 
pediatrician under this limitation exceed $42,500 over a 6-year period.
    (b) Optional exception for pediatricians. A pediatrician described 
in this paragraph is a Medicaid EP who does not meet the 30 percent 
patient volume requirements described in Sec. Sec. 495.304 and 495.306, 
but who meets the 20 percent patient volume requirements described in 
such sections.
    (c) Limitation to only one EHR incentive program. An EP may only 
receive an incentive payment from either Medicare or Medicaid in a 
payment year, but not both.
    (d) Exception for EPs to switch programs. An EP may change his or 
her EHR incentive payment program election once, consistent with Sec. 
495.60.
    (e) Limitation to one State only. A Medicaid EP or eligible hospital 
may receive an incentive payment from only one State in a payment year.
    (f) Incentive payments to hospitals. Incentive payments to an 
eligible hospital under this subpart are subject to all of the following 
conditions:
    (1) The payment is provided over a minimum of a 3-year period and 
maximum of a 6-year period.
    (2) The total incentive payment received over all payment years of 
the program is not greater than the aggregate EHR incentive amount, as 
calculated under paragraph (g) of this section.
    (3) No single incentive payment for a payment year may exceed 50 
percent of the aggregate EHR hospital incentive amount calculated under 
paragraph (g) of this section for an individual hospital.
    (4) No incentive payments over a 2-year period may exceed 90 percent 
of the aggregate EHR hospital incentive amount calculated under 
paragraph (g) of this section for an individual hospital.
    (5) No hospital may begin receiving incentive payments for any year 
after FY 2016, and after FY 2016, a hospital may not receive an 
incentive payment unless it received an incentive payment in the prior 
fiscal year.
    (6) Prior to FY 2016, payments can be made to an eligible hospital 
on a non-consecutive, annual basis for the fiscal year.
    (7) A multi-site hospital with one CMS Certification Number is 
considered one hospital for purposes of calculating payment.
    (8) The aggregate EHR hospital incentive amount calculated under 
paragraph (g) of this section is determined by the State from which the 
eligible hospital receives its first payment year incentive. If a 
hospital receives incentive payments from other States in subsequent 
years, total incentive payments received over all payment years of the 
program can be no greater than the aggregate EHR incentive amount 
calculated by the initial State.

[[Page 861]]

    (g) Calculation of the aggregate EHR hospital incentive amount. The 
aggregate EHR hospital incentive amount is calculated as the product of 
the (overall EHR amount) times (the Medicaid Share).
    (1) Overall EHR amount. The overall EHR amount for an eligible 
hospital is based upon a theoretical 4 years of payment the hospital 
would receive based, for each of such 4 years, upon the product of the 
following:
    (i) Initial amount. The initial amount is equal to the sum of--
    (A) The base amount which is set at $2,000,000 for each of the 
theoretical 4 years; plus
    (B) The discharge-related amount for the most recent continuous 12-
month period selected by the State, but ending before the federal fiscal 
year that serves as the first payment year. The discharge-related amount 
is the sum of the following, with acute-care inpatient discharges over 
the 12-month period and based upon the total acute-care inpatient 
discharges for the eligible hospital (regardless of any source of 
payment):
    (1) For the first through 1,149th acute-care inpatient discharge, 
$0.
    (2) For the 1,150th through the 23,000th acute-care inpatient 
discharge, $200.
    (3) For any acute-care inpatient discharge greater than the 
23,000th, $0.
    (C) For purposes of calculating the discharge-related amount under 
paragraph (g)(1)(i)(B) of this section, for the last 3 of the 
theoretical 4 years of payment, acute-care inpatient discharges are 
assumed to increase by the provider's average annual rate of growth for 
the most recent 3 years for which data are available per year. Negative 
rates of growth must be applied as such.
    (ii) Medicare share. The Medicare share, which equals 1.
    (iii) Transition factor. The transition factor which equals as 
follows:
    (A) For the first of the theoretical 4 years, 1.
    (B) For the second of the theoretical 4 years, \3/4\.
    (C) For the third of the theoretical 4 years, \1/2\.
    (D) For the fourth of the theoretical 4 years, \1/4\.
    (2) Medicaid share. The Medicaid share specified under this 
paragraph for an eligible hospital is equal to a fraction--
    (i) The numerator of which is the sum (for the 12-month period 
selected by the State and with respect to the eligible hospital) of--
    (A) The estimated number of acute-care inpatient-bed-days which are 
attributable to Medicaid individuals; and
    (B) The estimated number of acute-care inpatient-bed-days which are 
attributable to individuals who are enrolled in a managed care 
organization, a pre-paid inpatient health plan, or a pre-paid ambulatory 
health plan under part 438 of this chapter; and
    (ii) The denominator of which is the product of--
    (A) The estimated total number of acute-care inpatient-bed-days with 
respect to the eligible hospital during such period; and
    (B) The estimated total amount of the eligible hospital's charges 
during such period, not including any charges that are attributable to 
charity care, divided by the estimated total amount of the hospital's 
charges during such period.
    (iii) In computing acute-care inpatient-bed-days under paragraph 
(g)(2)(i) of this section, a State may not include estimated acute-care 
inpatient-bed-days attributable to individuals with respect to whom 
payment may be made under Medicare Part A, or acute-care inpatient-bed-
days attributable to individuals who are enrolled with a Medicare 
Advantage organization under Medicare Part C.
    (h) Approximate proxy for charity care. If the State determines that 
an eligible provider's data are not available on charity care necessary 
to calculate the portion of the formula specified in paragraph 
(g)(2)(ii)(B) of this section, the State may use that provider's data on 
uncompensated care to determine an appropriate proxy for charity care, 
but must include a downward adjustment to eliminate bad debt from 
uncompensated care data. The State must use auditable data sources.
    (i) Deeming. In the absence of the data necessary, with respect to 
an eligible hospital the amount described in paragraph (g)(2)(ii)(B) of 
this section

[[Page 862]]

must be deemed to be 1. In the absence of data, with respect to an 
eligible hospital, necessary to compute the amount described in 
paragraph (g)(2)(i)(B) of this section, the amount under such clause 
must be deemed to be 0.
    (j) Dual eligibility for incentives payments. A hospital may receive 
incentive payments from both Medicare and Medicaid if it meets all 
eligibility criteria in the payment year.
    (k) Payments to State-designated entities. Payments to entities 
promoting the adoption of certified EHR technology as designated by the 
State must meet the following requirements:
    (1) A Medicaid EP may reassign his or her incentive payment to an 
entity promoting the adoption of certified EHR technology, as defined in 
Sec. 495.302, and as designated by the State, only under the following 
conditions:
    (i) The State has established a method to designate entities 
promoting the adoption of EHR technology that comports with the Federal 
definition in Sec. 495.302.
    (ii) The State publishes and makes available to all EPs a voluntary 
mechanism for reassigning annual payments and includes information about 
the verification mechanism the State will use to ensure that the 
reassignment is voluntary and that no more than 5 percent of the annual 
payment is retained by the entity for costs not related to certified EHR 
technology.
    (2) [Reserved]

[75 FR 44565, July 28, 2010, as amended at 77 FR 54161, Sept. 4, 2012; 
80 FR 62954, Oct. 16, 2015]



Sec. 495.312  Process for payments.

    (a) General rule. States must have a process for making payments 
consistent with the requirements in subparts A and D of this part.
    (b) Reporting data consistent with this subpart. In order to receive 
a payment under this part, a provider must report the required data 
under subpart A and this subpart within the EHR reporting period 
described in Sec. 495.4.
    (c) State's role. (1) Except as specified in paragraph (c)(2) of 
this section, the State determines the provider's eligibility for the 
EHR incentive payment under subparts A and D of this part and approves, 
processes, and makes timely payments using a process approved by CMS.
    (2) At the State's option, CMS conducts the audits and handles any 
subsequent appeals, of whether eligible hospitals are meaningful EHR 
users on the States' behalf.
    (d) State disbursement. The State disburses an incentive payment to 
the provider based on the criteria described in subpart A and this 
subpart.
    (e) Timeframes. Payments are disbursed consistent with the following 
timeframes for each type of Medicaid eligible provider:
    (1) Medicaid EPs. States disburse payments consistent with the 
calendar year on a rolling basis following verification of eligibility 
for the payment year.
    (2) Medicaid eligible hospitals. States disburse payments consistent 
with the Federal fiscal year on a rolling basis following verification 
of eligibility for the payment year.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54162, Sept. 4, 2012]



Sec. 495.314  Activities required to receive an incentive payment.

    (a) First payment year. (1) In the first payment year, to receive an 
incentive payment, the Medicaid EP or eligible hospital must meet one of 
the following:
    (i) Demonstrate that during the payment year, it has adopted, 
implemented, or upgraded certified EHR technology, as defined in Sec. 
495.302.
    (ii) Demonstrate that during the EHR reporting period for a payment 
year, it is a meaningful EHR user as defined in Sec. 495.4.
    (2) A provider may notify the State of its non-binding intention to 
participate in the incentives program prior to having fulfilled all of 
the eligibility criteria.
    (b) Subsequent payment years. (1) In the second, third, fourth, 
fifth, and sixth payment years, to receive an incentive payment, the 
Medicaid EP or eligible hospital must demonstrate that during the EHR 
reporting period for the applicable payment year, it is a meaningful EHR 
user, as defined in Sec. 495.4.

[[Page 863]]

    (2) The automated reporting of the clinical quality measures will be 
accomplished using certified EHR technology interoperable with the 
system designated by the State to receive the data.



Sec. 495.316  State monitoring and reporting regarding activities 
required to receive an incentive payment.

    (a) Subject to Sec. 495.332 the State is responsible for tracking 
and verifying the activities necessary for a Medicaid EP or eligible 
hospital to receive an incentive payment for each payment year, as 
described in Sec. 495.314.
    (b) Subject to Sec. 495.332, the State must submit a State Medicaid 
HIT Plan to CMS that includes--
    (1) A detailed plan for monitoring, verifying and periodic auditing 
of the requirements for receiving incentive payments, as described in 
Sec. 495.314; and
    (2) A description of the how the State will collect and report on 
provider meaningful use of certified EHR technology.
    (c) Subject to Sec. Sec. 495.332 and 495.352, the State is required 
to submit to CMS annual reports, in the manner prescribed by CMS, on the 
following:
    (1) Provider adoption, implementation, or upgrade of certified EHR 
technology activities and payments; and
    (2) Aggregated, de-identified meaningful use data.
    (d)(1) The annual report described in paragraph (c) of this section 
must include, but is not limited to the following:
    (i) The number and type of providers who qualified for an incentive 
payment on the basis of having adopted, implemented, or upgraded 
certified EHR technology.
    (ii) Aggregated data tables representing the provider adoption, 
implementation, or upgrade of certified EHR technology.
    (iii) The number and type of providers who qualified for an 
incentive payment on the basis of demonstrating that they are meaningful 
users of certified EHR technology;
    (iv) Aggregated data tables representing the provider's clinical 
quality measures data; and
    (v) A description and quantitative data on how its incentive payment 
program addressed individuals with unique needs such as children.
    (2)(i) Subject to Sec. 495.332, the State may propose a revised 
definition for Stage 1 of meaningful use of certified EHR technology, 
subject to CMS prior approval, but only with respect to the following 
objectives:
    (A) Generate lists of patients by specific conditions to use for 
quality improvement, reduction of disparities, research or outreach.
    (B) Capability to submit electronic data to immunization registries 
or immunization information systems and actual submission except where 
prohibited, and according to applicable law and practice.
    (C) Capability to submit electronic data on reportable (as required 
by State or local law) lab results to public health agencies and actual 
submission except where prohibited according to applicable law and 
practice.
    (D) Capability to submit electronic syndromic surveillance data to 
public health agencies and actual submission except where prohibited and 
according to applicable law and practice.
    (ii) Subject to Sec. 495.332, the State may propose a revised 
definition for Stage 2 of meaningful use of certified EHR technology, 
subject to CMS prior approval, but only with respect to the following 
objectives:
    (A) Generate lists of patients by specific conditions to use for 
quality improvement, reduction of disparities, research, or outreach.
    (B) Capability to submit electronic data to immunization registries 
or immunization information systems, except where prohibited, and in 
accordance with applicable law and practice.
    (C) Capability to submit electronic reportable laboratory results to 
public health agencies, except where prohibited, and in accordance with 
applicable law and practice.
    (D) Capability to provide electronic syndromic surveillance data to 
public health agencies, except where prohibited, and in accordance with 
applicable law and practice.
    (E) Capability to identify and report cancer cases to a public 
health central cancer registry, except where prohibited, and in 
accordance with applicable law and practice.

[[Page 864]]

    (F) Capability to identify and report specific cases to a 
specialized registry (other than a cancer registry), except where 
prohibited, and in accordance with applicable law and practice.
    (iii) Subject to Sec. 495.332, the State may propose a revised 
definition for Stage 3 of meaningful use of CEHRT, subject to CMS prior 
approval, but only with respect to the public health and clinical data 
registry reporting objective described in Sec. 495.24(d)(8).
    (e) State failure to submit the required reports to CMS may result 
in discontinued or disallowed funding.
    (f) Each State must submit to CMS the annual report described in 
paragraph (c) of this section within 60 days of the end of the second 
quarter of the Federal fiscal year.
    (g) The State must, on a quarterly basis and in the manner 
prescribed by CMS, submit a report(s) on the following:
    (1) The State and payment year to which the quarterly report 
pertains.
    (2) Subject to paragraph (h)(2) of this section, provider-level 
attestation data for each eligible hospital that attests to 
demonstrating meaningful use for each payment year beginning with 2013 
and ending after 2018.
    (3) Subject to paragraph (h)(2) of this section, provider-level 
attestation data for each eligible EP that attests to demonstrating 
meaningful use for each payment year beginning with 2013 and ending 
after 2016.
    (h)(1) Subject to paragraph (h)(2) of this section, the quarterly 
report described in paragraph (g) of this section must include the 
following for each EP and eligible hospital:
    (i) The payment year number.
    (ii) The provider's National Provider Identifier or CCN, as 
appropriate.
    (iii) Attestation submission date.
    (iv) The state qualification.
    (v) The state qualification date, which is the beginning date of the 
provider's EHR reporting period for which it demonstrated meaningful 
use.
    (vi) The State disqualification, if applicable.
    (vii) The State disqualification date, which is the beginning date 
of the provider's EHR reporting period to which the provider attested 
but for which it did not demonstrate meaningful use, if applicable.
    (2) The quarterly report described in paragraph (g) of this section 
is not required to include information on EPs who are eligible for the 
Medicaid EHR incentive program on the basis of being a nurse 
practitioner, certified nurse-midwife or physician assistant.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54162, Sept. 4, 2012; 
80 FR 62954, Oct. 16, 2015; 81 FR 77557, Nov. 4, 2016; 83 FR 41711, Aug. 
17, 2018]



Sec. 495.318  State responsibilities for receiving FFP.

    In order to be provided FFP under section 1903(a)(3)(F) of the Act, 
a State must demonstrate to the satisfaction of HHS, that the State is--
    (a) Using the funds provided for the purposes of administering 
incentive payments to providers under this program, including tracking 
of meaningful use by Medicaid providers of EHR technology;
    (b) Conducting adequate oversight of the program, including routine 
tracking of meaningful use attestations and reporting mechanisms; and
    (c) Is pursuing initiatives to encourage the adoption of certified 
EHR technology to promote health care quality and the exchange of health 
care information, subject to applicable laws and regulations governing 
such exchange.



Sec. 495.320  FFP for payments to Medicaid providers.

    Subject to the requirements outlined in this subpart, FFP is 
available at 100 percent of State expenditures for payments to Medicaid 
eligible providers to encourage the adoption and meaningful use of 
certified EHR technology.



Sec. 495.322  FFP for reasonable administrative expenses.

    (a) Subject to prior approval conditions at Sec. 495.324, FFP is 
available at 90 percent in State expenditures for administrative 
activities in support of implementing incentive payments to Medicaid 
eligible providers.
    (b) FFP available under paragraph (a) of this section is available 
only for expenditures incurred on or before September 30, 2022, except 
for expenditures related to audit and appeal activities

[[Page 865]]

required under this subpart, which must be incurred on or before 
September 30, 2023.

[83 FR 41711, Aug. 17, 2018]



Sec. 495.324  Prior approval conditions.

    (a) A State must obtain prior written approval as specified in 
paragraph (b) of this section, when the State plans to initiate planning 
and implementation activities in support of Medicaid provider incentive 
payments encouraging the adoption and meaningful use of certified EHR 
technology with proposed Federal financial participation.
    (b) To receive 90 percent match, each State must receive prior 
approval for all of the following:
    (1) The HIT advance planning document and the implementation advance 
planning document.
    (2) For the acquisition solicitation documents and any contract that 
a State may utilize to complete activities under this subpart, unless 
specifically exempted by the Department of Health and Human Services, 
prior to release of the acquisition solicitation documents or prior to 
execution of the contract, when the contract is anticipated to or will 
exceed $500,000.
    (3) For contract amendments, unless specifically exempted by the 
Department of Health and Human Services, prior to execution of the 
contract amendment, involving contract cost increases exceeding $500,000 
or contract time extensions of more than 60 days.
    (4) The State Medicaid HIT plan.
    (c) Failure to submit any of the information specified in paragraph 
(b) of this section to the satisfaction of HHS may result in disapproval 
or suspension of project funding.
    (d) A State must obtain prior written approval from HHS of its 
justification for a sole source acquisition, when it plans to acquire 
noncompetitively from a nongovernmental source HIT equipment or 
services, with proposed FFP under this subpart if the total State and 
Federal acquisition cost is more than $500,000.

[75 FR 44565, July 28, 2010, as amended at 83 FR 41711, Aug. 17, 2018]



Sec. 495.326  Disallowance of FFP.

    If the HHS finds that any acquisition approved or modified under the 
provisions of this subpart fails to comply with the criteria, 
requirements, and other undertakings described in the approved HIT 
planning advance planning document and HIT implementation advance 
planning document to the detriment of the proper and efficient operation 
of the Medicaid program, payment of FFP may be disallowed. In the case 
of a suspension of approval of a HIT planning advance planning document 
and HIT implementation advance planning document, suspension would occur 
in the same manner as 45 CFR 205.37(c) and 307.40(a).



Sec. 495.328  Request for reconsideration of adverse determination.

    If CMS disapproves a State request for any elements of a State's 
advance planning document or State Medicaid HIT Plan under this subpart, 
or determines that requirements are met for approval on a date later 
than the date requested, the decision notice includes the following:
    (a) The finding of fact upon which the determination was made.
    (b) The procedures for appeal of the determination in the form of a 
request for reconsideration.



Sec. 495.330  Termination of FFP for failure to provide access 
to information.

    (a) HHS terminates FFP at any time if the Medicaid agency fails to 
provide State and Federal representatives with full access to records 
relating to HIT planning and implementation efforts, and the systems 
used to interoperate with electronic HIT, including on-site inspection.
    (b) The Department may request such access at any time to determine 
whether the conditions in this subpart are being met.



Sec. 495.332  State Medicaid health information technology (HIT) 
plan requirements.

    Each State Medicaid HIT plan must include all of the following 
elements:
    (a) State systems. For State systems, interoperability, and the 
current and future visions:

[[Page 866]]

    (1) A baseline assessment of the current HIT landscape environment 
in the State including the inventory of existing HIT in the State. The 
assessment must include a comprehensive--
    (i) Description of the HIT ``as-is'' landscape;
    (ii) Description of the HIT ``to-be'' landscape; and
    (iii) HIT roadmap and strategic plan for the next 5 years.
    (2) A description of how the State Medicaid HIT plan will be 
planned, designed, developed and implemented, including how it will be 
implemented in accordance with the Medicaid Information Technology 
Architecture (MITA) principles as described in the Medicaid Information 
Technology Framework 2.0. The MITA initiative--
    (i) Establishes national guidelines for technologies and processes 
that enable improved program administration for the Medicaid enterprise;
    (ii) Includes business, information and technology architectures 
that provide an overall framework for interoperability, as well as 
processes and planning guidelines for enabling State Medicaid 
enterprises to meet common objectives within the framework while 
supporting unique local needs; and
    (iii) Is important to the design and development of State EHR 
incentive payment systems.
    (3) A description of how intrastate systems, including the Medicaid 
Management Information System (MMIS) and other automated mechanized 
claims processing and information retrieval systems--
    (i) Have been considered in developing a HIT solution; and
    (ii) A plan that incorporates the design, development, and 
implementation phases for interoperability of such State systems with a 
description of how any planned systems enhancements support overall 
State and Medicaid goals.
    (4) A description of data-sharing components of HIT solutions.
    (5) A description of how each State will promote secure data 
exchange, where permissible under the Health Insurance Portability and 
Accountability Act (HIPAA) and other requirements included in ARRA.
    (6) A description of how each State will promote the use of data and 
technical standards to enhance data consistency and data sharing through 
common data-access mechanisms.
    (7) A description of how each State will support integration of 
clinical and administrative data.
    (8) A description of the process in place for ensuring improvements 
in health outcomes, clinical quality, or efficiency resulting from the 
adoption of certified EHR technology by beneficiaries of Medicaid 
incentive payments and a methodology for verifying such information.
    (9) A description of the process in place for ensuring that any 
certified EHR technology used as the basis for a payment incentive to 
Medicaid providers is compatible with State or Federal administrative 
management systems, including the MMIS or other automated claims 
processing system or information retrieval system and a methodology for 
verifying such information.
    (10) A description of how each State will adopt national data 
standards for health and data exchange and open standards for technical 
solutions as they become available.
    (11) A description of how the State intends to address the needs of 
underserved and vulnerable populations such as children, individuals 
with chronic conditions, Title IV-E foster care children, individuals in 
long-term care settings and the aged, blind, and disabled. This 
description must address the following:
    (i) Person centered goals and objectives and shared decision-making;
    (ii) Coordination of care across multiple service providers, funding 
sources, settings, and patient conditions--
    (iii) Universal design to ensure access by people with disabilities 
and older Americans; and
    (iv) Institutional discharge planning and diversion activities that 
are tied to community based service availability.
    (b) Eligibility. For eligibility, a description of the process in 
place for all of the following:

[[Page 867]]

    (1) For ensuring that each EP and eligible hospital meets all 
provider enrollment eligibility criteria upon enrollment and re-
enrollment to the Medicaid EHR payment incentive program.
    (2) For ensuring patient volume consistent with the criteria in 
Sec. Sec. 495.304 and 495.306 for each EP who practices predominantly 
in a FQHC or RHC and for each Medicaid EP who is a physician, 
pediatrician, nurse practitioner, certified nurse midwife or dentist and 
a methodology in place used to verify such information.
    (3) For ensuring that the EP or eligible hospital is a provider who 
meets patient volume consistent with the criteria in Sec. Sec. 495.304 
and 495.306 and a methodology in place used to verify such information.
    (4) For ensuring that each Medicaid EP is not hospital-based and a 
methodology in place used to verify such information.
    (5) To ensure that a hospital eligible for incentive payments has 
demonstrated an average length of stay of 25 days or less and a 
methodology for verifying such information.
    (6) For ensuring that at least one clinical location used for the 
calculation of the EP's patient volume has Certified EHR Technology 
during the payment year for which the EP is attesting.
    (c) Monitoring and validation. Subject to paragraph (g) of this 
section, for monitoring and validation of information States must 
include the following:
    (1) A description of the process in place for ensuring that, because 
of CMS' and the States' oversight responsibilities, all provider 
information for attestations including meaningful use, efforts to adopt, 
implement, or upgrade and any information added to the CMS Single 
Provider Repository including all information related to patient volume, 
NPI, Tax identification number (TIN), are all true and accurate and that 
any concealment or falsification of a material fact related to the 
attestation may result in prosecution under Federal and State laws and a 
methodology in place used to verify such information.
    (2) A description of the process in place for ensuring that the EP 
or eligible hospital is eligible to receive an incentive payment 
consistent with the criteria outlined in Sec. 495.314 and a methodology 
in place used to verify such information.
    (3) A description of the process in place for capturing attestations 
from each EP or eligible hospital that they have meaningfully used 
certified EHR technology during the EHR reporting period, and that they 
have adopted, implemented, or upgraded certified EHR technology and a 
description of the methodology in place used to verify such information.
    (4) A description of the process in place for capturing clinical 
quality data from each EP or eligible hospital and a description of the 
methodology in place used to verify such information.
    (5) A description of the process in place for monitoring the 
compliance of providers coming onto the program with different 
requirements depending upon their participation year and a methodology 
for verifying such information.
    (6) A list of the specific actions planned to implement the EHR 
incentive program, including a description and organizational charts for 
workgroups within State government including external partners.
    (7) A description of the process in place to ensure that no amounts 
higher than 100 percent of FFP will be claimed by the State for 
reimbursement of expenditures for State payments to Medicaid eligible 
providers for the certified EHR technology incentive payment program and 
a methodology for verifying such information.
    (8) A description of the process in place to ensure that no amounts 
higher than 90 percent of FFP will be claimed by the State for 
administrative expenses in administering the certified EHR technology 
incentive payment program and a methodology for verifying such 
information.
    (9) A description of the process and methodology for ensuring and 
verifying the following:
    (i) Amounts received under section 1903(a)(3)(F) of the Act with 
respect to payments to a Medicaid EP or eligible hospital are paid 
directly to such provider (or to an employer or facility to

[[Page 868]]

which such provider has assigned payments) without any deduction or 
rebate.
    (ii) All incentive payment reassignments to an entity promoting the 
adoption of certified EHR technology, as designated by the State, are 
voluntary for the Medicaid EP involved.
    (iii) Entities promoting the adoption of certified EHR technology do 
not retain more than 5 percent of such payments for costs not related to 
certified EHR technology (and support services including maintenance and 
training) that is for, or is necessary for the operation of, such 
technology.
    (10) A description of the process in place for ensuring that each 
Medicaid EP or eligible hospital that collects an EHR payment incentive 
has collected a payment incentive from only one State even if the 
provider is licensed to practice in multiple States and a methodology 
for verifying such information.
    (11)(i) A description of the process in place for ensuring that each 
EP or eligible hospital that wishes to participate in the EHR incentive 
payment program will receive a NPI; and
    (ii) A description of how the NPI will be used to coordinate with 
the CMS so that the EP will choose only one program from which to 
receive the incentive payment and the hospital payments are tracked 
accordingly.
    (12) A description of the process in place for ensuring that each EP 
or eligible hospital who wishes to participate in the EHR incentive 
payment program will provide a TIN to the State for purposes of the 
incentive payment.
    (d) Payments. For payments, States must provide descriptions of the 
following processes that are in place:
    (1) The process in place for ensuring that there is no duplication 
of Medicare and Medicaid incentive payments to EPs and a methodology for 
verifying such information.
    (2) The process in place to ensure that any existing fiscal 
relationships with providers to disburse the incentive payments through 
Medicaid managed care plans does not result in payments that exceed 105 
percent of the capitation rate, in order to comply with the Medicaid 
managed care incentive payment rules at Sec. 438.6(b)(2) of this 
chapter and a methodology for verifying such information.
    (3) The process in place to ensure that only appropriate funding 
sources are used to make Medicaid EHR incentive payments and the 
methodology for verifying such information.
    (4) The process in place and the methodology for verifying that 
information is available in order to ensure that Medicaid EHR incentive 
payments are made for no more than a total of 6 years; that no EP or 
eligible hospital begins receiving payments after 2016; that incentive 
payments cease after 2021; and that an eligible hospital does not 
receive incentive payments after FY 2016 unless the hospital received an 
incentive payment in the prior fiscal year.
    (5) The process in place to ensure that Medicaid EHR incentive 
payments are not paid at amounts higher than 85 percent of the net 
average allowable cost of certified EHR technology and the yearly 
maximum allowable payment thresholds and a methodology for verifying 
such information.
    (6) The process in place to ensure that all hospital calculations 
and hospital payment incentives are made consistent with the 
requirements of this part and a methodology for verifying such 
information.
    (7) The process in place to provide for the timely and accurate 
payment of incentive payments to EPs and eligible hospitals, including 
the timeframe specified by the State to meet the timely payment 
requirement.
    (8) The process in place and a methodology for verifying such 
information to provide that any monies that have been paid 
inappropriately as an improper payment or otherwise not in compliance 
with this subpart will be recouped and FFP will be repaid.
    (e) For combating fraud and abuse and for provider appeals. (1) A 
description of the process in place for a provider to appeal consistent 
with the criteria described in Sec. 495.370 and a methodology for 
verifying the following related to the EHR incentives payment program:
    (i) Incentive payments.
    (ii) Provider eligibility determinations.
    (iii) Demonstration of efforts to adopt, implement or upgrade and

[[Page 869]]

meaningful use eligibility for incentive payments under this part.
    (2) A description of the process in place, and a methodology for 
verifying such information, to address Federal laws and regulations 
designed to prevent fraud, waste, and abuse, including, but not limited 
to applicable provisions of Federal criminal law, the False Claims Act 
(32 U.S.C. 3729 et seq.), and the anti-kickback statute (section 
1128B(b) of the Act).
    (f) Optional--proposed alternatives. A State may choose to propose 
any of the following, but they must be included as an element in the 
State Medicaid HIT Plan for review and approval:
    (1) An alternative methodology for measuring patient volume, 
consistent with Sec. 495.306(g).
    (2)(i) A revised definition of meaningful use of certified EHR 
technology consistent with Sec. Sec. 495.4 and 495.316(d)(2) of this 
part.
    (ii) Any revised definition of meaningful use may not require 
additional functionality beyond that of certified EHR technology and 
conform with CMS guidance on Stage 1. See also Sec. 495.316(d)(2).
    (3) An alternative date within CY 2021 by which all ``EHR reporting 
periods'' (as defined under Sec. 495.4) for the CY 2021 payment year 
for Medicaid EPs demonstrating they are meaningful EHR users must end. 
The alternative date selected by the state must be earlier than October 
31, 2021, and must not be any earlier than the day prior to the 
attestation deadline for Medicaid EPs attesting to that state.
    (4) An alternative date within CY 2021 by which all clinical quality 
measure reporting periods for the CY 2021 payment year for Medicaid EPs 
demonstrating they are meaningful EHR users must end. The alternative 
date selected by the state must be earlier than October 31, 2021, and 
must not be any earlier than the day prior to the attestation deadline 
for Medicaid EPs attesting to that state.
    (5) For the CY 2019 payment year and beyond, a state-specific 
listing of which clinical quality measures selected by CMS are 
considered to be high priority measures for purposes of Medicaid EP 
clinical quality measure reporting.
    (g) Optional--signed agreement. At the State's option, the State may 
include a signed agreement indicating that the State does all of the 
following:
    (1) Designates CMS to conduct all audits and appeals of eligible 
hospitals' meaningful use attestations.
    (2) Is bound by the audit and appeal findings described in paragraph 
(g)(1) of this section.
    (3) Performs any necessary recoupments if audits (and any subsequent 
appeals) described in paragraph (g)(1) of this section determine that an 
eligible hospital was not a meaningful EHR user.
    (4) Is liable for any FFP granted to the State to pay eligible 
hospitals that, upon audit (and any subsequent appeal) are determined 
not to have been meaningful EHR users.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54162, Sept. 4, 2012; 
81 FR 27901, May 6, 2016; 83 FR 60096, Nov. 23, 2018]



Sec. 495.334  [Reserved]



Sec. 495.336  Health information technology planning advance planning
document requirements (HIT PAPD).

    Each State's HIT PAPD must contain the following:
    (a) A statement of need and objective which clearly state the 
purpose and objectives of the project to be accomplished and the 
necessity for the project.
    (b) A project management plan which addresses the following:
    (1) The planning project organization.
    (2) Planning activities and deliverables.
    (3) State and contractor resource needs.
    (4) Planning project procurement activities and schedule.
    (c) A specific budget for the planning of the project.
    (d) An estimated total project cost and a prospective State and 
Federal cost distribution, including planning and implementation.
    (e) A commitment to submit a HIT implementation advance planning 
document.
    (f) A commitment to conduct and complete activities which will 
result in the production of the State Medicaid

[[Page 870]]

HIT plan that includes conduct of the following activities:
    (1) A statewide HIT environmental baseline self-assessment.
    (2) An assessment of desired HIT future environment.
    (3) Development of benchmarks and transition strategies to move from 
the current environment to the desired future environment.
    (g) A commitment to submit the plan to CMS for approval.



Sec. 495.338  Health information technology implementation advance 
planning document requirements (HIT IAPD).

    Each State's HIT IAPD must contain the following:
    (a) The results of the activities conducted as a result of the HIT 
planning advance planning document, including the approved state 
Medicaid HIT plan.
    (b) A statement of needs and objectives.
    (c) A statement of alternative considerations.
    (d) A personnel resource statement indicating availability of 
qualified and adequate staff, including a project director to accomplish 
the project objectives.
    (e) A detailed description of the nature and scope of the activities 
to be undertaken and the methods to be used to accomplish the project.
    (f) The proposed activity schedule for the project.
    (g) A proposed budget including a consideration of all HIT 
implementation advance planning document activity costs, including but 
not limited to the following:
    (1) The cost to implement and administer incentive payments.
    (2) Procurement or acquisition.
    (3) State personnel.
    (4) Contractor services.
    (5) Hardware, software, and licensing.
    (6) Equipment and supplies.
    (7) Training and outreach.
    (8) Travel.
    (9) Administrative operations.
    (10) Miscellaneous expenses for the project.
    (h) An estimate of prospective cost distribution to the various 
State and Federal funding sources and the proposed procedures for 
distributing costs including:
    (1) Planned annual payment amounts;
    (2) Total of planned payment amounts; and
    (3) Calendar year of each planned annual payment amount.
    (4) A statement setting forth the security and interface 
requirements to be employed for all State HIT systems, and related 
systems, and the system failure and disaster recovery procedures 
available.



Sec. 495.340  As-needed HIT PAPD update and as-needed HIT IAPD
update requirements.

    Each State must submit a HIT PAPD update or a HIT IAPD no later than 
60 days after the occurrence of project changes including but not 
limited to any of the following:
    (a) A projected cost increase of $100,000 or more.
    (b) A schedule extension of more than 60 days for major milestones.
    (c) A significant change in planning approach or implementation 
approach, or scope of activities beyond that approved in the HIT 
planning advance planning document or the HIT implementation advance 
planning document.
    (d) A change in implementation concept or a change to the scope of 
the project.
    (e) A change to the approved cost allocation methodology.



Sec. 495.342  Annual HIT IAPD requirements.

    Each State is required to submit the HIT IAPD Updates 12 months from 
the date of the last CMS approved HIT IAPD and must contain the 
following:
    (a) A reference to the approved HIT PAPD/IAPD and all approved 
changes.
    (b) A project activity status which reports the status of the past 
year's major project tasks and milestones, addressing the degree of 
completion and tasks/milestones remaining to be completed and discusses 
past and anticipated problems or delays in meeting target dates in the 
approved HIT technology PAPD/IAPD and approved changes to it.
    (c) A report of all project deliverables completed in the past year 
and degree of completion for unfinished products.

[[Page 871]]

    (d) A project activity schedule for the remainder of the project.
    (e) A project expenditure status which consists of a detailed 
accounting of all expenditures for project development over the past 
year and an explanation of the differences between projected expenses in 
the approved HIT PAPD/IAPD and actual expenditures for the past year.
    (f) A report of any approved or anticipated changes to the 
allocation basis in the advance planning document's approved cost 
methodology.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54162, Sept. 4, 2012]



Sec. 495.344  Approval of the State Medicaid HIT plan, the HIT PAPD
and update, the HIT IAPD and update, and the annual HIT IAPD.

    HHS will not approve the State Medicaid HIT plan, HIT PAPD and 
update, HIT-IAPD and update, or annual IAPD if any of these documents do 
not include all of the information required under this subpart.



Sec. 495.346  Access to systems and records.

    The State agency must allow HHS access to all records and systems 
operated by the State in support of this program, including cost records 
associated with approved administrative funding and incentive payments 
to Medicaid providers. State records related to contractors employed for 
the purpose of assisting with implementation or oversight activities or 
providing assistance, at such intervals as are deemed necessary by the 
Department to determine whether the conditions for approval are being 
met and to determine the efficiency, economy, and effectiveness of the 
program.



Sec. 495.348  Procurement standards.

    (a) General rule. Procurements of HIT equipment and services are 
subject to the following procurement standards in paragraphs (b) through 
(f) of this section regardless of any conditions for prior approval. 
These standards--
    (1) Include a requirement for maximum practical open and free 
competition regardless of whether the procurement is formally advertised 
or negotiated.
    (2) Are established to ensure that such materials and services are 
obtained in a cost effective manner and in compliance with the 
provisions of applicable Federal statutes and executive orders.
    (3) Apply when the cost of the procurement is treated as a direct 
cost of an award.
    (b) Grantee responsibilities. The standards contained in this 
section do not relieve the Grantee of the contractual responsibilities 
arising under its contract(s).
    (1) The grantee is the responsible authority, without recourse to 
the Departmental awarding agency, regarding the settlement and 
satisfaction of all contractual and administrative issues arising out of 
procurements entered into in support of an award or other agreement. 
This includes disputes, claims, and protests of award, source evaluation 
or other matters of a contractual nature.
    (2) Matters concerning violation of statute are to be referred to 
such Federal, State or local authority as may have proper jurisdiction.
    (c) Codes of conduct. The grantee must maintain written standards of 
conduct governing the performance of its employees engaged in the award 
and administration of contracts.
    (1) No employee, officer, or agent must participate in the 
selection, award, or administration of a contract supported by Federal 
funds if a real or apparent conflict of interest would be involved.
    (2) Such a conflict would arise when the employee, officer, or 
agent, or any member of his or her immediate family, his or her partner, 
or an organization which employs or is about to employ any of the 
parties indicated herein, has a financial or other interest in the firm 
selected for an award.
    (3) The officers, employees, and agents of the grantee must neither 
solicit nor accept gratuities, favors, or anything of monetary value 
from contractors, or parties to sub agreements.
    (4) Grantees may set standards for situations in which the financial 
interest is not substantial or the gift is an unsolicited item of 
nominal value.
    (5) The standards of conduct provide for disciplinary actions to be 
applied

[[Page 872]]

for violations of such standards by officers, employers, or agents of 
the grantees.
    (d) Competition. All procurement transactions must be conducted in a 
manner to provide, to the maximum extent practical, open and free 
competition.
    (1) The grantee must be alert to organizational conflicts of 
interest as well as noncompetitive practices among contractors that may 
restrict or eliminate competition or otherwise restrain trade.
    (2) In order to ensure objective contractor performance and 
eliminate unfair competitive advantage, contractors that develop or 
draft grant applications, or contract specifications, requirements, 
statements of work, invitations for bids and requests for proposals must 
be excluded from competing for such procurements.
    (3) Awards must be made to the bidder or offer or whose bid or offer 
is responsive to the solicitation and is most advantageous to the 
grantee, price, quality, and other factors considered.
    (4) Solicitations must clearly set forth all requirements that the 
bidder or offer or must fulfill in order for the bid or offer to be 
evaluated by the grantee.
    (5) Any and all bids or offers may be rejected when it is in the 
grantee's interest to do so.
    (e) Procurement procedures. All grantees must establish written 
procurement procedures. These procedures must provide, at a minimum, the 
following:
    (1) Grantees avoid purchasing unnecessary items.
    (2) When appropriate, an analysis is made of lease and purchase 
alternatives to determine which would be the most economical and 
practical procurement for the grantee and the Federal government.
    (3) Solicitations for goods and services provide for all of the 
following:
    (i) A clear and accurate description of the technical requirements 
for the material, product or service to be procured. In competitive 
procurements, such a description must not contain features which unduly 
restrict competition.
    (ii) Requirements which the bidder or offer must fulfill and all 
other factors to be used in evaluating bids or proposals.
    (iii) A description, whenever practicable, of technical requirements 
in terms of functions to be performed or performance required, including 
the range of acceptable characteristics or minimum acceptable standards.
    (iv) The specific features of brand name or equal descriptions that 
bidders are required to meet when such items are included in the 
solicitation.
    (v) The acceptance, to the extent practicable and economically 
feasible, of products and services dimensioned in the metric system of 
measurement.
    (vi) Preference, to the extent practicable and economically 
feasible, for products and services that conserve natural resources and 
protect the environment and are energy efficient.
    (4) Positive efforts must be made by grantees to utilize small 
businesses, minority-owned firms, and women's business enterprises, 
whenever possible. Grantees of Departmental awards must take all of the 
following steps to further this goal:
    (i) Ensure that small businesses, minority-owned firms, and women's 
business enterprises are used to the fullest extent practicable.
    (ii) Make information on forthcoming opportunities available and 
arrange time frames for purchases and contracts to encourage and 
facilitate participation by small businesses, minority-owned firms, and 
women's business enterprises.
    (iii) Consider in the contract process whether firms competing for 
larger contracts intend to subcontract with small businesses, minority-
owned firms, and women's business enterprises.
    (iv) Encourage contracting with consortia of small businesses, 
minority-owned firms and women's business enterprises when a contract is 
too large for one of these firms to handle individually.
    (v) Use the services and assistance, as appropriate, of such 
organizations as the Small Business Administration and the Department of 
Commerce's Minority Business Development Agency in the solicitation and 
utilization of

[[Page 873]]

small businesses, minority-owned firms and women's business enterprises.
    (5) The type of procuring instruments used (for example, fixed price 
contracts, cost reimbursable contracts, purchase orders, and incentive 
contracts) must be determined by the grantee but must be appropriate for 
the particular procurement and for promoting the best interest of the 
program or project involved.
    (6) The ``cost-plus-a-percentage-of-cost'' or ``percentage of 
construction cost'' methods of contracting must not be used.
    (7) Contracts must be made only with responsible contractors who 
possess the potential ability to perform successfully under the terms 
and conditions of the proposed procurement.
    (8) Consideration must be given to such matters as contractor 
integrity, record of past performance, financial and technical resources 
or accessibility to other necessary resources.
    (9) In certain circumstances, contracts with certain parties are 
restricted by agencies' implementation of Executive Orders 12549 and 
12689, ``Debarment and Suspension'' as described in 2 CFR part 376.
    (10) Some form of cost or price analysis must be made and documented 
in the procurement files in connection with every procurement action.
    (11) Price analysis may be accomplished in various ways, including 
the comparison of price quotations submitted, market prices, and similar 
indicia, together with discounts.
    (12) Cost analysis is the review and evaluation of each element of 
cost to determine reasonableness, allocability, and allowability.
    (13) Procurement records and files for purchases in excess of the 
simplified acquisition threshold must include the following at a 
minimum:
    (i) Basis for contractor selection.
    (ii) Justification for lack of competition when competitive bids or 
offers are not obtained.
    (iii) Basis for award cost or price.
    (f) Contract administration. A system for contract administration 
must be maintained to ensure contractor conformance with the terms, 
conditions and specifications of the contract and to ensure adequate and 
timely follow up of all purchases. Grantees must evaluate contractor 
performance and document, as appropriate, whether contractors have met 
the terms, conditions, and specifications of the contract.
    (g) Additional contract requirements. The grantee must include, in 
addition to provisions to define a sound and complete agreement, the 
following provisions in all contracts, which must also be applied to 
subcontracts:
    (1) Contracts in excess of the simplified acquisition threshold must 
contain contractual provisions or conditions that allow for 
administrative, contractual, or legal remedies in instances in which a 
contractor violates or breaches the contract terms, and provide for such 
remedial actions as may be appropriate.
    (2) All contracts in excess of the simplified acquisition threshold 
(currently $100,000) must contain suitable provisions for termination by 
the grantee, including the manner by which termination must be effected 
and the basis for settlement.
    (h) Conditions for default or termination. Such contracts must 
describe conditions under which the contract may be terminated for 
default as well as conditions where the contract may be terminated 
because of circumstances beyond the control of the contractor.
    (i) Access to contract materials and staff. All negotiated contracts 
(except those for less than the simplified acquisition threshold) 
awarded by grantees must include a provision to the effect that the 
grantee, the Departmental awarding agency, the U.S. Comptroller General, 
or any of their duly authorized representatives, must have access to any 
books, documents, papers and records and staff of the contractor which 
are directly pertinent to a specific program for the purpose of making 
audits, examinations, excerpts and transcriptions.



Sec. 495.350  State Medicaid agency attestations.

    (a) The State must provide assurances to HHS that amounts received 
with respect to sums expended that are attributable to payments to a 
Medicaid provider for the adoption of EHR are

[[Page 874]]

paid directly to such provider, or to an employer or facility to which 
such provider has assigned payments, without any deduction or rebate.



Sec. 495.352  Reporting requirements.

    (a) Beginning with the first quarter of calendar year 2016, each 
State must submit to HHS on a quarterly basis a progress report, in the 
manner prescribed by HHS, documenting specific implementation and 
oversight activities performed during the quarter, including progress in 
implementing the State's approved Medicaid HIT plan.
    (b) The quarterly progress reports must include, but need not be 
limited to providing, updates on the following:
    (1) State system implementation dates.
    (2) Provider outreach.
    (3) Auditing.
    (4) State-specific State Medicaid HIT Plan tasks.
    (5) State staffing levels and changes.
    (6) The number and type of providers that qualified for an incentive 
payment on the basis of having adopted, implemented or upgraded CEHRT 
and the amounts of incentive payments.
    (7) The number and type of providers that qualified for an incentive 
payment on the basis of having demonstrated that they are meaningful 
users of CEHRT and the amounts of incentive payments.
    (c) States must submit the quarterly progress reports described in 
this section within 30 days after the end of each federal fiscal year 
quarter.

[80 FR 62955, Oct. 16, 2015]



Sec. 495.354  Rules for charging equipment.

    Equipment acquired under this subpart is subject to the public 
assistance program requirements concerning the computation of claims for 
Federal financial participation in accordance with the provisions of 45 
CFR part 95, subpart G.



Sec. 495.356  Nondiscrimination requirements.

    State agencies and any other beneficiaries or subbeneficiaries of 
Federal financial assistance provided under this subpart are subject to 
the nondiscrimination requirements in 45 CFR parts 80, 84, and 91.
    (a) These regulations in 45 CFR parts 80, 84, and 91 prohibit 
individuals from being excluded from participation in, being denied the 
benefits of, or being otherwise subjected to discrimination under any 
program or activity which received Federal financial assistance.
    (b) Specifically, 45 CFR part 80 prohibits discrimination on the 
basis of race, color, or national origin; 45 CFR part 84 prohibits 
discrimination on the basis of disability; and 45 CFR part 91 prohibits 
discrimination on the basis of age.



Sec. 495.358  Cost allocation plans.

    State agencies that acquire HIT equipment and services under this 
subpart are subject to cost allocation plan requirements in 45 CFR part 
95.



Sec. 495.360  Software and ownership rights.

    (a) General rule. The State or local government must include a 
clause in all procurement instruments that provides that the State or 
local government will have all ownership rights in software or 
modifications thereof and associated documentation designed, developed 
or installed with FFP under this Subpart.
    (b) Federal license. HHS reserves a royalty-free, non-exclusive, and 
irrevocable license to reproduce, publish or otherwise use and to 
authorize others to use for Federal government purposes, the software, 
modifications, and documentation designed, developed or installed with 
FFP under this Subpart.
    (c) Proprietary software. Proprietary operating/vendor software 
packages such as software that is owned and licensed for use by third 
parties, which are provided at established catalog or market prices and 
sold or leased to the general public must not be subject to the 
ownership provisions in paragraphs (a) and (b) of this section.
    (d) Limitation. Federal financial participation is not available for 
proprietary applications software developed specifically for the public 
assistance programs covered under this subpart.

[[Page 875]]



Sec. 495.362  Retroactive approval of FFP with an effective date
of February 18, 2009.

    For administrative activities performed by a State, without 
obtaining prior approval, which are in support of planning for incentive 
payments to providers, a State may request consideration of FFP by 
recorded request in a HIT advance planning document or implementation 
advance planning document update. In such a consideration, the agency 
takes into consideration overall Federal interests which may include any 
of the following:
    (a) The acquisition must not be before February 18, 2009.
    (b) The acquisition must be reasonable, useful, and necessary.
    (c) The acquisition must be attributable to payments for reasonable 
administrative expenses under section 1903(a)(3)(F)(ii) of the Act.



Sec. 495.364  Review and assessment of administrative activities and
expenses of Medicaid provider health information technology adoption
and operation.

    (a) CMS conducts periodic reviews on an as needed basis to assess 
the State's progress described in its approved HIT planning advance 
planning document and health information technology implementation 
advance planning document.
    (b) During planning, development, and implementation, these reviews 
will generally be limited to the overall progress, work performance, 
expenditure reports, project deliverables, and supporting documentation.
    (c) CMS assesses the State's overall compliance with the approved 
advance planning document and provide technical assistance and 
information sharing from other State projects.
    (d) CMS will, on a continuing basis, review, assess and inspect the 
planning, design, development, implementation, and operation of 
activities and payments for reasonable administrative expenses related 
to the administration of payment for Medicaid provider HIT adoption and 
operation payments to determine the extent to which such activities meet 
the following:
    (1) All requirements of this subpart.
    (2) The goals and objectives stated in the approved HIT 
implementation advance planning document and State Medicaid HIT plan.
    (3) The schedule, budget, and other conditions of the approved HIT 
implementation advance planning document and State Medicaid HIT plan.



Sec. 495.366  Financial oversight and monitoring of expenditures.

    (a) General rule. (1) The State must have a process in place to 
estimate expenditures for the Medicaid EHR payment incentive program 
using the Medicaid Budget Expenditure System.
    (2) The State must have a process in place to report actual 
expenditures for the Medicaid EHR payment incentive program using the 
Medicaid Budget Expenditure System.
    (3) The State must have an automated payment and information 
retrieval mechanized system, (Medicaid Management Information System) to 
make EHR payment incentives, to ensure Medicaid provider eligibility, to 
ensure the accuracy of payment incentives, and to identify potential 
improper payments.
    (b) Provider eligibility as basis for making payment. Subject to 
Sec. 495.332, the State must do all of the following:
    (1) Collect and verify basic information on Medicaid providers to 
assure provider enrollment eligibility upon enrollment or re-enrollment 
to the Medicaid EHR payment incentive program.
    (2) Collect and verify basic information on Medicaid providers to 
assure patient volume.
    (3) Collect and verify basic information on Medicaid providers to 
assure that EPs are not hospital-based including the determination that 
substantially all health care services are not furnished in a hospital 
inpatient or emergency room setting.
    (4) Collect and verify basic information on Medicaid providers to 
assure that EPs are practicing predominantly in a Federally-qualified 
health center or rural health clinic.
    (5) Have a process in place to assure that Medicaid providers who 
wish to participate in the EHR incentive payment program has or will 
have a NPI and will choose only one program from

[[Page 876]]

which to receive the incentive payment using the NPI, a TIN, and CMS' 
national provider election database.
    (c) Meaningful use and efforts to adopt, implement, or upgrade to 
certified electronic health record technology to make payment. Subject 
to Sec. 495.312, 495.314, and Sec. 495.332, the State must annually 
collect and verify information regarding the efforts to adopt, 
implement, or upgrade certified EHR technology and the meaningful use of 
said technology before making any payments to providers.
    (d) Claiming Federal reimbursement for State expenditures. Subject 
to Sec. 495.332, the State must do the following:
    (1) Assure that State expenditures are claimed in accordance with, 
including but not limited to, applicable Federal laws, regulations, and 
policy guidance.
    (2) Have a process in place to assure that expenditures for 
administering the Medicaid EHR incentive payment program will not be 
claimed at amounts higher than 90 percent of the cost of such 
administration.
    (3) Have a process in place to assure that expenditures for payment 
of Medicaid EHR incentive payments will not be claimed at amounts higher 
than 100 percent of the cost of such payments to Medicaid providers.
    (e) Improper Medicaid electronic health record payment incentives. 
(1) Subject to Sec. 495.332, the State must have a process in place to 
assure that no duplicate Medicaid EHR payment incentives are paid 
between the Medicare and Medicaid programs, or paid by more than one 
State even if the provider is licensed to practice in multiple States, 
or paid within more than one area of a State.
    (2) Subject to Sec. 495.332, the State must have a process in place 
to assure that Medicaid EHR incentive payments are made without 
reduction or rebate, have been paid directly to an eligible provider or 
to an employer, a facility, or an eligible third-party entity to which 
the Medicaid eligible provider has assigned payments.
    (3) Subject to Sec. 495.332, the State must have a process in place 
to assure that that Medicaid EHR incentive payments are made for no more 
than 6 years; that no EP or eligible hospital begins receiving payments 
after 2016; that incentive payments cease after 2021; and that an 
eligible hospital does not receive incentive payments after FY 2016 
unless the hospital received an incentive payment in the prior fiscal 
year.
    (4) Subject to Sec. 495.332, the State must have a process in place 
to assure that only appropriate funding sources are used to make 
Medicaid EHR incentive payments.
    (5) Subject to Sec. 495.332, the State must have a process in place 
to assure that Medicaid EHR incentive payments are not paid at amounts 
higher than 85 percent of the net average allowable cost of certified 
EHR technology and the yearly maximum allowable payment thresholds.
    (6) Subject to Sec. 495.332, the State must have a process in place 
to assure that for those entities promoting the adoption of EHR 
technology, the Medicaid EHR incentive payments are paid on a voluntary 
basis and that these entities do not retain more than 5 percent of such 
payments for costs not related to certified EHR technology.
    (7) Subject to Sec. 495.332, the State must have a process in place 
to assure that any existing fiscal relationships with providers to 
disburse the incentive through Medicaid managed care plans does not 
exceed 105 percent of the capitation rate, in order to comply with the 
Medicaid managed care incentive payment rules at Sec. 438.6(b)(2) of 
this chapter and a methodology for verifying such information.
    (8) The State must not request reimbursement for Federal financial 
participation unless all requirements of this subpart have been 
satisfied.

[75 FR 44565, July 28, 2010, as amended at 75 FR 81887, Dec. 29, 2010; 
81 FR 27901, May 6, 2016]



Sec. 495.368  Combating fraud and abuse.

    (a) General rule. (1) The State must comply with Federal 
requirements to--
    (i) Ensure the qualifications of the providers who request Medicaid 
EHR incentive payments;
    (ii) Detect improper payments; and
    (iii) In accordance with Sec. 455.15 and Sec. 455.21 of this 
chapter, refer suspected cases of fraud and abuse to the Medicaid Fraud 
Control Unit.

[[Page 877]]

    (2) The State must take corrective action in the case of improper 
EHR payment incentives to Medicaid providers.
    (b) Providers' statements regarding submission of documentation 
containing falsification or concealment of a material fact on EHR 
incentive payment documentation. For any forms on which a provider 
submits information necessary to the determination of eligibility to 
receive EHR payments, the State must obtain a statement that meets the 
following requirements:
    (1) Is signed by the provider and contains the following statement: 
``This is to certify that the foregoing information is true, accurate, 
and complete. I understand that Medicaid EHR incentive payments 
submitted under this provider number will be from Federal funds, and 
that any falsification, or concealment of a material fact may be 
prosecuted under Federal and State laws.''
    (2) Appears directly above the claimant's signature, or if it is 
printed on the reverse of the form, a reference to the statements must 
appear immediately preceding the provider's signature.
    (3) Is resubmitted upon a change in provider representative.
    (4) Is updated as needed.
    (c) Overpayments. States must repay to CMS all Federal financial 
participation received by providers identified as an overpayment 
regardless of recoupment from such providers, within 60 days of 
discovery of the overpayment, in accordance with sections 1903(a)(1), 
(d)(2), and (d)(3) of the Act and part 433 subpart F of the regulations.
    (d) Complying with Federal laws and regulations. States must comply 
with all Federal laws and regulations designed to prevent fraud, waste, 
and abuse, including, but not limited to applicable provisions of 
Federal criminal law, the False Claims Act (32 U.S.C. 3729 et seq.), and 
the anti-kickback statute (section 1128B(b) of the Act).



Sec. 495.370  Appeals process for a Medicaid provider receiving 
electronic health record incentive payments.

    (a) The State must have a process in place consistent with the 
requirements established in Sec. 447.253(e) of this chapter for a 
provider or entity to appeal the following issues related to the HIT 
incentives payment program:
    (1) Incentive payments.
    (2) Incentive payment amounts.
    (3) Provider eligibility determinations.
    (4) Demonstration of adopting, implementing, and upgrading, and 
meaningful use eligibility for incentives under this subpart.
    (b) Subject to paragraph (a) of this section, the State's process 
must ensure the following:
    (1) That the provider (whether an individual or an entity) has an 
opportunity to challenge the State's determination under this part by 
submitting documents or data or both to support the provider's claim.
    (2) That such process employs methods for conducting an appeal that 
are consistent with the State's Administrative Procedure law(s).
    (c) The State must provide that the provider (whether individual or 
entity) is also given any additional appeals rights that would otherwise 
be available under procedures established by the State.
    (d) This section does not apply in the case that CMS conducts the 
audits and handles any subsequent appeals under Sec. 495.312(c)(2) of 
this part.

[75 FR 44565, July 28, 2010, as amended at 77 FR 54161, Sept. 4, 2012]



 PART 498_APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT 
 PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS
 THAT AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN 
 THE MEDICAID PROGRAM--Table of Contents



                      Subpart A_General Provisions

Sec.
498.1 Statutory basis.
498.2 Definitions.
498.3 Scope and applicability.
498.4 NFs subject to appeals process in part 498.
498.5 Appeal rights.
498.10 Appointment of representatives.
498.11 Authority of representatives.
498.13 Fees for services of representatives.
498.15 Charge for transcripts.

[[Page 878]]

498.17 Filing of briefs with the ALJ or Departmental Appeals Board, and 
          opportunity for rebuttal.

       Subpart B_Initial, Reconsidered, and Revised Determinations

498.20 Notice and effect of initial determinations.
498.22 Reconsideration.
498.23 Withdrawal of request for reconsideration.
498.24 Reconsidered determination.
498.25 Notice and effect of reconsidered determination.

      Subpart C_Reopening of Initial or Reconsidered Determinations

498.30 Limitation on reopening.
498.32 Notice and effect of reopening and revision.

                           Subpart D_Hearings

498.40 Request for hearing.
498.42 Parties to the hearing.
498.44 Designation of hearing official.
498.45 Disqualification of Administrative Law Judge.
498.47 Prehearing conference.
498.48 Notice of prehearing conference.
498.49 Conduct of prehearing conference.
498.50 Record, order, and effect of prehearing conference.
498.52 Time and place of hearing.
498.53 Change in time and place of hearing.
498.54 Joint hearings.
498.56 Hearing on new issues.
498.58 Subpoenas.
498.60 Conduct of hearing.
498.61 Evidence.
498.62 Witnesses.
498.63 Oral and written summation.
498.64 Record of hearing.
498.66 Waiver of right to appear and present evidence.
498.68 Dismissal of request for hearing.
498.69 Dismissal for abandonment.
498.70 Dismissal for cause.
498.71 Notice and effect of dismissal and right to request review.
498.72 Vacating a dismissal of request for hearing.
498.74 Administrative Law Judge's decision.
498.76 Removal of hearing to Departmental Appeals Board.
498.78 Remand by the Administrative Law Judge.
498.79 Timeframes for deciding an enrollment appeal before an ALJ.

               Subpart E_Departmental Appeals Board Review

498.80 Right to request Departmental Appeals Board review of 
          Administrative Law Judge's decision or dismissal.
498.82 Request for Departmental Appeals Board review.
498.83 Departmental Appeals Board action on request for review.
498.85 Procedures before the Departmental Appeals Board on review.
498.86 Evidence admissible on review.
498.88 Decision or remand by the Departmental Appeals Board.
498.90 Effect of Departmental Appeals Board decision.
498.95 Extension of time for seeking judicial review.

 Subpart F_Reopening of Decisions Made by Administrative Law Judges or 
                     the Departmental Appeals Board

498.100 Basis, timing, and authority for reopening an ALJ or Board 
          decision.
498.102 Revision of reopened decision.
498.103 Notice and effect of revised decision.

    Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.

    Source: 52 FR 22446, June 12, 1987, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 498.1  Statutory basis.

    (a) Section 1866(h) of the Act provides for a hearing and for 
judicial review of the hearing for any institution or agency 
dissatisfied with a determination that it is not a provider, or with any 
determination described in section 1866(b)(2) of the Act.
    (b) Section 1866(b)(2) of the Act lists determinations that serve as 
a basis for termination of a provider agreement.
    (c) Sections 1128 (a) and (b) of the Act provide for exclusion of 
certain individuals or entities because of conviction of crimes related 
to their participation in Medicare and section 1128(f) provides for 
hearing and judicial review for exclusions.
    (d) Section 1156 of the Act establishes certain obligations for 
practitioners and providers of health care services, and provides 
sanctions and penalties for those that fail to meet those obligations.
    (e)-(f) [Reserved]
    (g) Section 1866(j) of the Act provides for a hearing and judicial 
review for any provider or supplier whose application for enrollment or 
reenrollment in Medicare is denied or whose billing privileges are 
revoked.

[[Page 879]]

    (h) Section 1128A(c)(2) of the Act provides that the Secretary may 
not collect a civil money penalty until the affected entity has had 
notice and opportunity for a hearing.
    (i) Section 1819(h) of the Act--
    (1) Provides that, for SNFs found to be out of compliance with the 
requirements for participation, specified remedies may be imposed 
instead of, or in addition to, termination of the facility's Medicare 
provider agreement; and
    (2) Makes certain provisions of section 1128A of the Act applicable 
to civil money penalties imposed on SNFs.
    (j) Section 1891(e) of the Act provides that, for home health 
agencies (HHAs) found to be out of compliance with the conditions of 
participation, specified remedies may be imposed instead of, or in 
addition to, termination of the HHA's Medicare provider agreement.
    (k) Section 1891(f) of the Act--
    (1) Requires the Secretary to develop a range of such remedies; and
    (2) Makes certain provisions of section 1128A of the Act applicable 
to civil money penalties imposed on HHAs.

[52 FR 22446, June 12, 1987, as amended at 59 FR 56251, Nov. 10, 1994; 
61 FR 32349, June 24, 1996; 73 FR 36462, June 27, 2008]



Sec. 498.2  Definitions.

    As used in this part--
    Affected party means a provider, prospective provider, supplier, 
prospective supplier, or practitioner that is affected by an initial 
determination or by any subsequent determination or decision issued 
under this part, and ``party'' means the affected party or CMS, as 
appropriate. For provider or supplier enrollment appeals, an affected 
party includes CMS or a CMS contractor.
    ALJ stands for Administrative Law Judge.
    Departmental Appeals Board or Board means a Board established in the 
Office of the Secretary to provide impartial review of disputed 
decisions made by the operating components of the Department.
    OIG stands for the Department's Office of the Inspector General.
    Prospective provider means any of the entities specified in the 
definition of provider under this section that seeks to be approved for 
coverage of its services by Medicare or to have any facility or 
organization determined to be a department of the provider or provider-
based entity under Sec. 413.65 of this chapter.
    Prospective supplier means any of the listed entities specified in 
the definition of supplier in this section that seek to be approved for 
coverage of its services by Medicare.
    Provider means any of the following:
    (1) Any of the following entities that have in effect an agreement 
to participate in Medicare:
    (i) Hospital.
    (ii) Transplant center.
    (iii) Critical access hospital (CAH).
    (iv) Skilled nursing facility (SNF).
    (v) Comprehensive outpatient rehabilitation facility (CORF).
    (vi) Home health agency (HHA).
    (vii) Hospice.
    (viii) Religious nonmedical health care institution (RNHCI).
    (2) Any of the following entities that have in effect an agreement 
to participate in Medicare but only to furnish outpatient physical 
therapy or outpatient speech pathology services.
    (i) Clinic.
    (ii) Rehabilitation agency.
    (iii) Public health agency.
    (3) An entity that has in effect an agreement to participate in 
Medicare but only to furnish opioid use disorder treatment services.
    Supplier means any of the following entities that have in effect an 
agreement to participate in Medicare:
    (1) An independent laboratory.
    (2) Supplier of durable medical equipment prosthetics, orthotics, or 
supplies (DMEPOS).
    (3) Ambulance service provider.
    (4) Independent diagnostic testing facility.
    (5) Physician or other practitioner such as physician assistant.
    (6) Physical therapist in independent practice.
    (7) Supplier of portable X-ray services.
    (8) Rural health clinic (RHC).
    (9) Federally qualified health center (FQHC).
    (10) Ambulatory surgical center (ASC).

[[Page 880]]

    (11) An entity approved by CMS to furnish outpatient diabetes self-
management training.
    (12) End-stage renal disease (ESRD) treatment facility that is 
approved by CMS as meeting the conditions for coverage of its services.
    (13) A site approved by CMS to furnish intensive cardiac 
rehabilitation services.

[52 FR 22446, June 12, 1987, as amended at 53 FR 6551, Mar. 1, 1988; 57 
FR 24984, June 12, 1992; 58 FR 30677, May 26, 1993; 59 FR 6579, Feb. 11, 
1994; 59 FR 56251, Nov. 10, 1994; 61 FR 32350, June 24, 1996; 62 FR 
46037, Aug. 29, 1997; 65 FR 18549, Apr. 7, 2000; 65 FR 83154, Dec. 29, 
2000; 68 FR 66721, Nov. 28, 2003; 71 FR 31054, May 31, 2006; 72 FR 
15280, Mar. 30, 2007; 73 FR 36462, June 27, 2008; 74 FR 62014, Nov. 25, 
2009; 84 FR 63204, Nov. 15, 2019]



Sec. 498.3  Scope and applicability.

    (a) Scope. (1) This part sets forth procedures for reviewing initial 
determinations that CMS makes with respect to the matters specified in 
paragraph (b) of this section, and that the OIG makes with respect to 
the matters specified in paragraph (c) of this section. It also 
specifies, in paragraph (d) of this section, administrative actions that 
are not subject to appeal under this part.
    (2) The determinations listed in this section affect participation 
in the Medicare program. Many of the procedures of this part also apply 
to other determinations that do not affect participation in Medicare. 
Some examples follow:
    (i) CMS's determination to terminate an NF's Medicaid provider 
agreement.
    (ii) CMS's determination to cancel the approval of an ICF/IID under 
section 1910(b) of the Act.
    (iii) CMS's determination, under the Clinical Laboratory Improvement 
Act (CLIA), to impose alternative sanctions or to suspend, limit, or 
revoke the certificate of a laboratory even though it does not 
participate in Medicare.
    (iv) CMS's determination to impose sanctions on the individual who 
is the administrator of a NF for failure to comply with the requirements 
at Sec. 483.75(r) of this chapter.
    (3) The following parts of this chapter specify the applicability of 
the provisions of this part 498 to sanctions or remedies imposed on the 
indicated entities or individuals:
    (i) Part 431, subpart D--for nursing facilities (NFs).
    (ii) Part 488, subpart E (Sec. 488.330(e))--for SNFs and NFs.
    (iii) Part 488, subpart E (Sec. 488.330(e)) and subpart F (Sec. 
488.446)--for SNFs and NFs and their administrators.
    (b) Initial determinations by CMS. CMS makes initial determinations 
with respect to the following matters:
    (1) Whether a prospective provider qualifies as a provider.
    (2) Whether a prospective department of a provider, remote location 
of a hospital, satellite facility, or provider-based entity qualifies 
for provider-based status under Sec. 413.65 of this chapter, or whether 
such a facility or entity currently treated as a department of a 
provider, remote location of a hospital, satellite facility, or a 
provider-based entity no longer qualifies for that status under Sec. 
413.65 of this chapter.
    (3) Whether an institution is a hospital qualified to elect to claim 
payment for all emergency hospital services furnished in a calendar 
year.
    (4) Whether an institution continues to remain in compliance with 
the qualifications for claiming reimbursement for all emergency services 
furnished in a calendar year.
    (5) Whether a prospective supplier meets the conditions for coverage 
of its services as those conditions are set forth elsewhere in this 
chapter.
    (6) Whether the services of a supplier continue to meet the 
conditions for coverage.
    (7) Whether a physical therapist in independent practice or a 
chiropractor meets the requirements for coverage of his or her services 
as set forth in subpart D of part 486 of this chapter and Sec. 410.22 
of this chapter, respectively.
    (8) The termination of a provider agreement in accordance with Sec. 
489.53 of this chapter, or the termination of a rural health clinic 
agreement in accordance with Sec. 405.2404 of this chapter, or the 
termination of a Federally qualified health center agreement in 
accordance with Sec. 405.2436 of this chapter.
    (9) CMS's cancellation, under section 1910(b) of the Act, of an ICF/
IID's approval to participate in Medicaid.

[[Page 881]]

    (10) Whether, for purposes of rate setting and reimbursement, an 
ESRD treatment facility is considered to be hospital-based or 
independent.
    (11) [Reserved]
    (12) Whether a hospital, skilled nursing facility, home health 
agency, or hospice program meets or contimues to meet the advance 
directives requirements specified in subpart I of part 489 of this 
chapter.
    (13) Except as provided at paragraph (d)(12) of this section for 
SNFs, NFs, and HHAs, the finding of noncompliance leading to the 
imposition of enforcement actions specified in Sec. 488.406 or Sec. 
488.820 of this chapter, but not the determination as to which sanction 
was imposed. The scope of review on the imposition if a civil money 
penalty is specified in Sec. Sec. 488.438(e) and 488.845(h) of this 
chapter.
    (14) The level of noncompliance found by CMS in a SNF, NF, or HHA 
but only if a successful challenge on this issue would affect--
    (i) The range of civil money penalty amounts that CMS could collect 
(for SNFs or NFs, the scope of review during a hearing on the imposition 
of a civil money penalty is set forth in Sec. 488.438(e) of this 
chapter and for HHAs, the scope of review during a hearing on the 
imposition of a civil money penalty is set forth in Sec. 488.845(h) of 
this chapter); or
    (ii) A finding of substandard quality of care that results in the 
loss of approval for a SNF or NF of its nurse aide training program.
    (15) The effective date of a Medicare provider agreement or supplier 
approval.
    (16) The finding of substandard quality of care that leads to the 
loss by a SNF or NF of the approval of its nurse aide training program.
    (17)(i) Whether to deny or revoke a provider's or supplier's 
Medicare enrollment in accordance with Sec. 424.530 or Sec. 424.535 of 
this chapter;
    (ii) Whether, under Sec. 424.535(c)(2)(i) of this chapter, to add 
years to a provider's or supplier's existing reenrollment bar; or
    (iii) Whether, under Sec. 424.535(c)(3) of this chapter, an 
individual or entity other than the provider or supplier that is the 
subject of the second revocation was the actual subject of the first 
revocation.
    (18) The level of noncompliance found by CMS with respect to the 
failure of an individual who is the administrator of a SNF to comply 
with the requirements at Sec. 483.75(r) of this chapter, and the 
appropriate sanction to be imposed under Sec. 488.446 of this chapter.
    (19) Whether a physician or practitioner has failed to properly opt-
out, failed to maintain opt-out, failed to timely renew opt-out, failed 
to privately contract, or failed to properly terminate opt-out.
    (20) An individual or entity is to be included on the preclusion 
list as defined in Sec. 422.2 or Sec. 423.100 of this chapter.
    (c) Initial determinations by the OIG. The OIG makes initial 
determinations with respect to the following matters:
    (1) The termination of a provider agreement in accordance with part 
1001, subpart C of this title.
    (2) The suspension, or exclusion from coverage and the denial of 
reimbursement for services furnished by a provider, practitioner, or 
supplier, because of fraud or abuse, or conviction of crimes related to 
participation in the program, in accordance with part 1001, subpart B of 
this title.
    (3) The imposition of sanctions in accordance with part 1004 of this 
title.
    (d) Administrative actions that are not initial determinations. 
Administrative actions that are not initial determination (and therefore 
not subject to appeal under this part) include but are not limited to 
the following:
    (1) The finding that a provider or supplier determined to be in 
compliance with the conditions or requirements for participation or for 
coverage has deficiencies.
    (2) The finding that a prospective provider does not meet the 
conditions of participation set forth elsewhere in this chapter, if the 
prospective provider is, nevertheless, approved for participation in 
Medicare on the basis of special access certification, as provided in 
subpart B of part 488 of this chapter.
    (3) The refusal to enter into a provider agreement because the 
prospective provider is unable to give satisfactory assurance of 
compliance with the requirements of title XVIII of the Act.

[[Page 882]]

    (4) The finding that an entity that had its provider agreement 
terminated may not file another agreement because the reasons for 
terminating the previous agreement have not been removed or there is 
insufficient assurance that the reasons for the exclusion will not 
recur.
    (5) The determination not to reinstate a suspended or excluded 
practitioner, provider, or supplier because the reason for the 
suspension or exclusion has not been removed, or there is insufficient 
assurance that the reason will not recur.
    (6) The finding that the services of a laboratory are covered as 
hospital services or as physician's services, rather than as services of 
an independent laboratory, because the laboratory is not independent of 
the hospital or of the physician's office.
    (7) The refusal to accept for filing an election to claim payment 
for all emergency hospital services furnished in a calendar year because 
the institution--
    (i) Had previously charged an individual or other person for 
services furnished during that calendar year;
    (ii) Submitted the election after the close of that calendar year; 
or
    (iii) Had previously been notified of its failure to continue to 
comply.
    (8) The finding that the reason for the revocation of a supplier's 
right to accept assignment has not been removed or there is insufficient 
assurance that the reason will not recur.
    (9) The finding that a hospital accredited by the Joint Commission 
on Accreditation of Hospitals or the American Osteopathic Association is 
not in compliance with a condition of participation, and a finding that 
that hospital is no longer deemed to meet the conditions of 
participation.
    (10) For a SNF, NF, or HHA--
    (i) The finding that the provider's deficiencies pose immediate 
jeopardy to the health or safety of the residents or patients;
    (ii) Except as provided in paragraph (b)(13) of this section, a 
determination by CMS as to the provider's level of noncompliance; and
    (iii) For SNFs and NFs, the imposition of State monitoring.
    (11) The choice of alternative sanction or remedy to be imposed on a 
provider or supplier.
    (12) The determination that the accreditation requirements of a 
national accreditation organization do not provide (or do not continue 
to provide) reasonable assurance that the entities accredited by the 
accreditation organization meet the applicable long-term care 
requirements, conditions for coverage, conditions of certification, 
conditions of participation, or CLIA condition level requirements.
    (13) The determination that requirements imposed on a State's 
laboratories under the laws of that State do not provide (or do not 
continue to provide) reasonable assurance that laboratories licensed or 
approved by the State meet applicable CLIA requirements.
    (14) The choice of alternative sanction or remedy to be imposed on a 
provider or supplier.
    (15) A decision by the State survey agency as to when to conduct an 
initial survey of a prospective provider or supplier.
    (e) Exclusion of civil rights issues. The procedures in this subpart 
do not apply to the adjudication of issues relating to a provider's 
compliance with civil rights requirements that are set forth in part 489 
of this chapter. Those issues are handled through the Department's 
Office of Civil Rights.

[52 FR 22446, June 12, 1987]

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



Sec. 498.4  NFs subject to appeals process in part 498.

    A NF is considered a provider for purposes of this part when it has 
in effect an agreement to participate in Medicaid, including an 
agreement to participate in both Medicaid and Medicare and it is a--
    (a) State-operated NF; or
    (b) Non State-operated NF that is subject to compliance action as a 
result of--
    (1) A validation survey by CMS; or

[[Page 883]]

    (2) CMS's review of the State's survey findings.

[59 FR 56252, Nov. 10, 1994]



Sec. 498.5  Appeal rights.

    (a) Appeal rights of prospective providers. (1) Any prospective 
provider dissatisfied with an initial determination or revised initial 
determination that it does not qualify as a provider may request 
reconsideration in accordance with Sec. 498.22(a).
    (2) Any prospective provider dissatisfied with a reconsidered 
determination under paragraph (a)(1) of this section, or a revised 
reconsidered determination under Sec. 498.30, is entitled to a hearing 
before an ALJ.
    (b) Appeal rights of providers. Any provider dissatisfied with an 
initial determination to terminate its provider agreement is entitled to 
a hearing before an ALJ.
    (c) Appeal rights of providers and prospective providers. Any 
provider or prospective provider dissatisfied with a hearing decision 
may request Departmental Appeals Board review, and has a right to seek 
judicial review of the Board's decision.
    (d) Appeal rights of prospective suppliers. (1) Any prospective 
supplier dissatisfied with an initial determination or a revised initial 
determination that its services do not meet the conditions for coverage 
may request reconsideration in accordance with Sec. 498.22(a).
    (2) Any prospective supplier dissatisfied with a reconsidered 
determination under paragraph (d)(1) of this section, or a revised 
reconsidered determination under Sec. 498.30, is entitled to a hearing 
before an ALJ.
    (e) Appeal rights of suppliers. Any supplier dissatisfied with an 
initial determination that the services subject to the determination no 
longer meet the conditions for coverage, is entitled to a hearing before 
an ALJ.
    (f) Appeal rights of suppliers and prospective suppliers. (1) Any 
supplier or prospective supplier dissatisfied with the hearing decision 
may request Departmental Appeals Board review of the ALJ's decision.
    (2) A supplier or prospective supplier dissatisfied with an ALJ 
decision may request Board review, and has a right to seek judicial 
review of the Board's decision.
    (g) Appeal rights for certain practitioners. A physical therapist in 
independent practice or a chiropractor dissatisfied with a determination 
that he or she does not meet the requirements for coverage of his or her 
services has the same appeal rights as suppliers have under paragraphs 
(d), (e) and (f) of this section.
    (h) Appeal rights for nonparticipating hospitals that furnish 
emergency services. A nonparticipating hospital dissatisfied with a 
determination or decision that it does not qualify to elect to claim 
payment for all emergency services furnished during a calendar year has 
the same appeal rights that providers have under paragraph (a), (b), and 
(c) of this section.
    (i) Appeal rights for suspended or excluded practitioners, 
providers, or suppliers. (1) Any practitioner, provider, or supplier who 
has been suspended, or whose services have been excluded from coverage 
in accordance with Sec. 498.3(c)(2), or has been sanctioned in 
accordance with Sec. 498.3(c)(3), is entitled to a hearing before an 
ALJ.
    (2) Any suspended or excluded practitioner, provider, or supplier 
dissatisfied with a hearing decision may request Departmental Appeals 
Board review and has a right to seek judicial review of the Board's 
decision by filing an action in Federal district court.
    (j) Appeal rights for Medicaid ICFs/IID terminated by CMS. (1) Any 
Medicaid ICF/IID that has had its approval cancelled by CMS in 
accordance with Sec. 498.3(b)(8) has a right to a hearing before an 
ALJ, to request Departmental Appeals Board review of the hearing 
decision, and to seek judicial review of the Board's decision.
    (2) The Medicaid agreement remains in effect until the period for 
requesting a hearing has expired or, if the facility requests a hearing, 
until a hearing decision is issued, unless CMS--
    (i) Makes a written determination that continuation of provider 
status for the SNF or ICF constitutes an immediate and serious threat to 
the health and safety of patients and specifies the reasons for that 
determination; and

[[Page 884]]

    (ii) Certifies that the facility has been notified of its 
deficiencies and has failed to correct them.
    (k) Appeal rights of NFs. Under the circumstances specified in Sec. 
431.153 (g) and (h) of this chapter, an NF has a right to a hearing 
before an ALJ, to request Board review of the hearing decision, and to 
seek judicial review of the Board's decision.
    (l) Appeal rights related to provider enrollment. (1) Any 
prospective provider, an existing provider, prospective supplier or 
existing supplier dissatisfied with an initial determination or revised 
initial determination related to the denial or revocation of Medicare 
billing privileges may request reconsideration in accordance with Sec. 
498.22(a).
    (2) CMS, a CMS contractor, any prospective provider, an existing 
provider, prospective supplier, or existing supplier dissatisfied with a 
reconsidered determination under paragraph (l)(1) of this section, or a 
revised reconsidered determination under Sec. 498.30, is entitled to a 
hearing before an ALJ.
    (3) CMS, a CMS contractor, any prospective provider, an existing 
provider, prospective supplier, or existing supplier dissatisfied with a 
hearing decision may request Board review, and any prospective provider, 
an existing provider, prospective supplier, or existing supplier has a 
right to seek judicial review of the Board's decision.
    (4) Scope of review. For appeals of denials based on Sec. 
424.530(a)(10) of this chapter related to temporary moratoria, the scope 
of review will be limited to whether the temporary moratorium applies to 
the provider or supplier appealing the denial. The agency's basis for 
imposing a temporary moratorium is not subject to review.
    (m) Appeal rights of an individual who is the administrator of a SNF 
or NF. An individual who is the administrator of a SNF or NF who is 
dissatisfied with the decision of CMS to impose sanctions authorized 
under Sec. 488.446 of this chapter is entitled to a hearing before an 
ALJ, to request Board review of the hearing decision, and to seek 
judicial review of the Board's decision.
    (n) Appeal rights of individuals and entities on preclusion list. 
(1)(i) Any individual or entity that is dissatisfied with an initial 
determination or revised initial determination that they are to be 
included on the preclusion list (as defined in Sec. 422.2 or Sec. 
423.100 of this chapter) may request a reconsideration in accordance 
with Sec. 498.22(a).
    (ii)(A) If the individual's or entity's inclusion on the preclusion 
list is based on a Medicare revocation under Sec. 424.535 of this 
chapter and the individual or entity receives contemporaneous notice of 
both actions, the individual or entity may request a joint 
reconsideration of both the preclusion list inclusion and the revocation 
in accordance with Sec. 498.22(a).
    (B) The individual or entity may not submit separate reconsideration 
requests under paragraph (n)(1)(ii)(A) of this section for inclusion on 
the preclusion list or a revocation if the individual or entity received 
contemporaneous notice of both actions.
    (2) If CMS or the individual or entity under paragraph (n)(1) of 
this section is dissatisfied with a reconsidered determination under 
paragraph (n)(1) of this section, or a revised reconsidered 
determination under Sec. 498.30, CMS or the individual or entity is 
entitled to a hearing before an ALJ.
    (3) If CMS or the individual or entity under paragraph (n)(2) of 
this section is dissatisfied with a hearing decision as described in 
paragraph (n)(2) of this section, CMS or the individual or entity may 
request Board review and the individual or entity has a right to seek 
judicial review of the Board's decision.

[52 FR 22446, June 12, 1987, as amended at 57 FR 43925, Sept. 23, 1992; 
59 FR 56252, Nov. 10, 1994; 61 FR 32350, June 24, 1996; 73 FR 36462, 
June 27, 2008; 76 FR 9512, Feb. 18, 2011; 76 FR 5970, Feb. 2, 2011; 78 
FR 16805, Mar. 19, 2013; 79 FR 72533, Dec. 5, 2014; 83 FR 16757, Apr. 
16, 2018; 84 FR 15844, Apr. 16, 2019]



Sec. 498.10  Appointment of representatives.

    (a) An affected party may appoint as its representative anyone not 
disqualified or suspended from acting as a representative in proceedings 
before the Secretary or otherwise prohibited by law.
    (b) If the representative appointed is not an attorney, the party 
must file written notice of the appointment with CMS, the ALJ, or the 
Departmental Appeals Board.

[[Page 885]]

    (c) If the representative appointed is an attorney, the attorney's 
statement that he or she has the authority to represent the party is 
sufficient.



Sec. 498.11  Authority of representatives.

    (a) A representative appointed and qualified in accordance with 
Sec. 498.10 may, on behalf of the represented party--
    (1) Give and accept any notice or request pertinent to the 
proceedings set forth in this part;
    (2) Present evidence and allegations as to facts and law in any 
proceedings affecting that party to the same extent as the party; and
    (3) Obtain information to the same extent as the party.
    (b) A notice or request may be sent to the affected party, to the 
party's representative, or to both. A notice or request sent to the 
representative has the same force and effect as if it had been sent to 
the party.



Sec. 498.13  Fees for services of representatives.

    Fees for any services performed on behalf of an affected party by an 
attorney appointed and qualified in accordance with Sec. 498.10 are not 
subject to the provisions of section 206 of Title II of the Act, which 
authorizes the Secretary to specify or limit those fees.



Sec. 498.15  Charge for transcripts.

    A party that requests a transcript of prehearing or hearing 
proceedings or Board review must pay the actual or estimated cost of 
preparing the transcript unless, for good cause shown by that party, the 
payment is waived by the ALJ or the Departmental Appeals Board, as 
appropriate.

[52 FR 22446, June 12, 1987, as amended at 61 FR 51021, Sept. 30, 1996]



Sec. 498.17  Filing of briefs with the ALJ or Departmental Appeals
Board, and opportunity for rebuttal.

    (a) Filing of briefs and related documents. If a party files a brief 
or related document such as a written argument, contention, suggested 
finding of fact, conclusion of law, or any other written statement, it 
must submit an original and one copy to the ALJ or the Departmental 
Appeals Board, as appropriate. The material may be filed by mail or in 
person and must include a statement certifying that a copy has been 
furnished to the other party.
    (b) Opportunity for rebuttal. (1) The other party will have 20 days 
from the date of mailing or personal service to submit any rebuttal 
statement or additional evidence. If a party submits a rebuttal 
statement or additional evidence, it must file an original and one copy 
with the ALJ or the Board and furnish a copy to the other party.
    (2) The ALJ or the Board will grant an opportunity to reply to the 
rebuttal statement only if the party shows good cause.



       Subpart B_Initial, Reconsidered, and Revised Determinations



Sec. 498.20  Notice and effect of initial determinations.

    (a) Notice of initial determination--(1) General rule. CMS or the 
OIG, as appropriate, mails notice of an initial determination to the 
affected party, setting forth the basis or reasons for the 
determination, the effect of the determination, and the party's right to 
reconsideration, if applicable, or to a hearing.
    (2) Special rules: Independent laboratories and suppliers of 
portable x-ray services. If CMS determines that an independent 
laboratory or a supplier of portable x-ray services no longer meets the 
conditions for coverage of some or all of its services, the notice--
    (i) Specifies an effective date of termination of coverage that is 
at least 15 days after the date of the notice;
    (ii) Is also sent to physicians, hospitals, and other parties that 
might use the services of the laboratory or supplier; and
    (iii) In the case of laboratories, specifies the categories of 
laboratory tests that are no longer covered.
    (3) Special rules: Nonparticipating hospitals that elect to claim 
payment for emergency services. If CMS determines that a 
nonparticipating hospital no longer qualifies to elect to claim payment 
for all emergency services furnished in a calendar year, the notice--
    (i) States the calendar year to which the determination applies;

[[Page 886]]

    (ii) Specifies an effective date that is at least 5 days after the 
date of the notice; and
    (iii) Specifies that the determination applies to services 
furnished, in the specified calendar year, to patients accepted (as 
inpatients or outpatients) on or after the effective date of the 
determination.
    (4) Other special rules. Additional rules pertaining, for example, 
to content and timing of notice, notice to the public and to other 
entities, and time allowed for submittal of additional information, are 
set forth elsewhere in this chapter, as follows:

Part 405 Subpart X--for rural health clinics.
Part 416--for ambulatory surgical centers.
Part 489--for providers, when their provider agreements have been 
terminated.
Part 1001, Subpart B--for excluded or suspended providers, suppliers, 
physicians, or practitioners.
Part 1001, Subpart C--for providers, when their provider agreements are 
terminated by the OIG.
Part 1004--for sanctioned providers and practitioners.

    (b) Effect of initial determination. An initial determination is 
binding unless it is--
    (1) Reconsidered in accordance with Sec. 498.24;
    (2) Reversed or modified by a hearing decision in accordance with 
Sec. 498.78; or
    (3) Revised in accordance with Sec. 498.32 or Sec. 498.100.



Sec. 498.22  Reconsideration.

    (a) Right to reconsideration. CMS or one of its contractors 
reconsiders an initial determination that affects a prospective provider 
or supplier, or a hospital seeking to qualify to claim payment for all 
emergency hospital services furnished in a calendar year, if the 
affected party files a written request in accordance with paragraphs (b) 
and (c) of this section. For denial or revocation of enrollment, 
prospective providers and suppliers and providers and suppliers have a 
right to reconsideration.
    (b) Request for reconsideration: Manner and timing. The affected 
party specified in paragraph (a) of this section, if dissatisfied with 
the initial determination may request reconsideration by filing the 
request--
    (1) With CMS or with the State survey agency, or in the case of 
prospective supplier the entity specified in the notice of initial 
determination;
    (2) Directly or through its legal representative or other authorized 
official; and
    (3) Within 60 days from receipt of the notice of initial 
determination, unless the time is extended in accordance with paragraph 
(d) of this section. The date of receipt will be presumed to be 5 days 
after the date on the notice unless there is a showing that it was, in 
fact, received earlier or later.
    (c) Content of request. The request for reconsideration must state 
the issues, or the findings of fact with which the affected party 
disagrees, and the reasons for disagreement.
    (d) Extension of time to file a request for reconsideration. (1) If 
the affected party is unable to file the request within the 60 days 
specified in paragraph (b) of this section, it may file a written 
request with CMS, stating the reasons why the request was not filed 
timely.
    (2) CMS will extend the time for filing a request for 
reconsideration if the affected party shows good cause for missing the 
deadline.

[52 FR 22446, June 12, 1987, as amended at 73 FR 36462, June 27, 2008]



Sec. 498.23  Withdrawal of request for reconsideration.

    A request for reconsideration is considered withdrawn if the 
requestor files a written withdrawal request before CMS mails the notice 
of reconsidered determination, and CMS approves the withdrawal request.



Sec. 498.24  Reconsidered determination.

    When a request for reconsideration has been properly filed in 
accordance with Sec. 498.22, CMS--
    (a) Receives written evidence and statements that are relevant and 
material to the matters at issue and are submitted within a reasonable 
time after the request for reconsideration;
    (b) Considers the initial determination, the findings on which the 
initial determination was based, the evidence considered in making the 
initial determination, and any other written evidence submitted under 
paragraph (a) of this section, taking into account facts

[[Page 887]]

relating to the status of the prospective provider or supplier 
subsequent to the initial determination; and
    (c) Makes a reconsidered determination, affirming or modifying the 
initial determination and the findings on which it was based.



Sec. 498.25  Notice and effect of reconsidered determination.

    (a) Notice. (1) CMS mails notice of a reconsidered determination to 
the affected party.
    (2) The notice gives the reasons for the determination.
    (3) If the determination is adverse, the notice specifies the 
conditions or requirements of law or regulations that the affected party 
fails to meet, and informs the party of its right to a hearing.
    (b) Effect. A reconsidered determination is binding unless--
    (1) CMS or the OIG, as appropriate, further revises the revised 
determination; or
    (2) The revised determination is reversed or modified by a hearing 
decision.



      Subpart C_Reopening of Initial or Reconsidered Determinations



Sec. 498.30  Limitation on reopening.

    An initial or reconsidered determination that a prospective provider 
is a provider or that a hospital qualifies to elect to claim payment for 
all emergency services furnished in a calendar year may not be reopened. 
CMS or the OIG, as appropriate, may on its own initiative, reopen any 
other initial or reconsidered determination, within 12 months after the 
date of notice of the initial determination.



Sec. 498.32  Notice and effect of reopening and revision.

    (a) Notice. (1) CMS or the OIG, as appropriate, gives the affected 
party notice of reopening and of any revision of the reopened 
determination.
    (2) The notice of revised determination states the basis or reason 
for the revised determination.
    (3) If the determination is that a supplier or prospective supplier 
does not meet the conditions for coverage of its services, the notice 
specifies the conditions with respect to which the affected party fails 
to meet the requirements of law and regulations, and informs the party 
of its right to a hearing.
    (b) Effect. A revised determination is binding unless
    (1) The affected party requests a hearing before an ALJ; or
    (2) CMS or the OIG further revises the revised determination.



                           Subpart D_Hearings



Sec. 498.40  Request for hearing.

    (a) Manner and timing of request. (1) An affected party entitled to 
a hearing under Sec. 498.5 may file a request for a hearing with the 
ALJ office identified in the determination letter.
    (2) The affected party or its legal representative or other 
authorized official must file the request in writing within 60 days from 
receipt of the notice of initial, reconsidered, or revised determination 
unless that period is extended in accordance with paragraph (c) of this 
section. (Presumed date of receipt is determined in accordance with 
Sec. 498.22(b)(3)).
    (b) Content of request for hearing. The request for hearing must--
    (1) Identify the specific issues, and the findings of fact and 
conclusions of law with which the affected party disagrees; and
    (2) Specify the basis for contending that the findings and 
conclusions are incorrect.
    (c) Extension of time for filing a request for hearing. If the 
request was not filed within 60 days--
    (1) The affected party or its legal representative or other 
authorized official may file with the ALJ a written request for 
extension of time stating the reasons why the request was not filed 
timely.
    (2) For good cause shown, the ALJ may extend the time for filing the 
request for hearing.

[52 FR 22446, June 12, 1987, as amended at 73 FR 36462, June 27, 2008]



Sec. 498.42  Parties to the hearing.

    The parties to the hearing are the affected party and CMS or the 
OIG, as appropriate.

[[Page 888]]



Sec. 498.44  Designation of hearing official.

    (a) The Secretary or his or her delegate designates an ALJ or a 
member or members of the Board to conduct hearings.
    (b) If appropriate, the Secretary or the delegate may designate 
another ALJ or another member or other members of the Board to conduct 
the hearing.
    (c) As used in this part, ``ALJ'' includes any ALJ of the Department 
of Health and Human Services or members of the Board who are designated 
to conduct a hearing.

[73 FR 36462, June 27, 2008]



Sec. 498.45  Disqualification of Administrative Law Judge.

    (a) An ALJ may not conduct a hearing in a case in which he or she is 
prejudiced or partial to the affected party or has any interest in the 
matter pending for decision.
    (b) A party that objects to the ALJ designated to conduct the 
hearing must give notice of its objections at the earliest opportunity.
    (c) The ALJ will consider the objections and decide whether to 
withdraw or proceed with the hearing.
    (1) If the ALJ withdraws, another will be designated to conduct the 
hearing.
    (2) If the ALJ does not withdraw, the objecting party may, after the 
hearing, present its objections to the Departmental Appeals Board as 
reasons for changing, modifying, or reversing the ALJ's decision or 
providing a new hearing before another ALJ.



Sec. 498.47  Prehearing conference.

    (a) At any time before the hearing, the ALJ may call a prehearing 
conference for the purpose of delineating the issues in controversy, 
identifying the evidence and witnesses to be presented at the hearing, 
and obtaining stipulations accordingly.
    (b) On the request of either party or on his or her own motion, the 
ALJ may adjourn the prehearing conference and reconvene at a later date.



Sec. 498.48  Notice of prehearing conference.

    (a) Timing of notice. The ALJ will fix a time and place for the 
prehearing conference and mail written notice to the parties at least 10 
days before the scheduled date.
    (b) Content of notice. The notice will inform the parties of the 
purpose of the conference and specify what issues are sought to be 
resolved, agreed to, or excluded.
    (c) Additional issues. Issues other than those set forth in the 
notice of determination or the request for hearing may be considered at 
the prehearing conference if--
    (1) Either party gives timely notice to that effect to the ALJ and 
the other party; or
    (2) The ALJ raises the issues in the notice of prehearing conference 
or at the conference.



Sec. 498.49  Conduct of prehearing conference.

    (a) The prehearing conference is open to the affected party or its 
representative, to the CMS or OIG representatives and their technical 
advisors, and to any other persons whose presence the ALJ considers 
necessary or proper.
    (b) The ALJ may accept the agreement of the parties as to the 
following:
    (1) Facts that are not in controversy.
    (2) Questions that have been resolved favorably to the affected 
party after the determination in dispute.
    (3) Remaining issues to be resolved.
    (c) The ALJ may request the parties to indicate the following:
    (1) The witnesses that will be present to testify at the hearing.
    (2) The qualifications of those witnesses.
    (3) The nature of other evidence to be submitted.



Sec. 498.50  Record, order, and effect of prehearing conference.

    (a) Record of prehearing conference. (1) A record is made of all 
agreements and stipulations entered into at the prehearing conference.
    (2) The record may be transcribed at the request of either party or 
the ALJ.
    (b) Order and opportunity to object. (1) The ALJ issues an order 
setting forth

[[Page 889]]

the results of the prehearing conference, including the agreements made 
by the parties as to facts not in controversy, the matters to be 
considered at the hearing, and the issues to be resolved.
    (2) Copies of the order are sent to all parties and the parties have 
10 days to file objections to the order.
    (3) After the 10 days have elapsed, the ALJ settles the order.
    (c) Effect of prehearing conference. The agreements and stipulations 
entered into at the prehearing conference are binding on all parties, 
unless a party presents facts that, in the opinion of the ALJ, would 
make an agreement unreasonable or inequitable.



Sec. 498.52  Time and place of hearing.

    (a) The ALJ fixes a time and place for the hearing and gives the 
parties written notice at least 10 days before the scheduled date.
    (b) The notice informs the parties of the general and specific 
issues to be resolved at the hearing.



Sec. 498.53  Change in time and place of hearing.

    (a) The ALJ may change the time and place for the hearing either on 
his or her own initiative or at the request of a party for good cause 
shown, or may adjourn or postpone the hearing.
    (b) The ALJ may reopen the hearing for receipt of new evidence at 
any time before mailing the notice of hearing decision.
    (c) The ALJ gives the parties reasonable notice of any change in 
time or place or any adjournment or reopening of the hearing.



Sec. 498.54  Joint hearings.

    When two or more affected parties have requested hearings and the 
same or substantially similar matters are at issue, the ALJ may, if all 
parties agree, fix a single time and place for the prehearing conference 
or hearing and conduct all proceedings jointly. If joint hearings are 
held, a single record of the proceedings is made and a separate decision 
issued with respect to each affected party.



Sec. 498.56  Hearing on new issues.

    (a) Basic rules. (1) Within the time limits specified in paragraph 
(b) of this section, the ALJ may, at the request of either party, or on 
his or her own motion, provide a hearing on new issues that impinge on 
the rights of the affected party.
    (2) Except for provider or supplier enrollment appeals which are 
addressed in Sec. 498.56(e), the ALJ may consider new issues even if 
CMS or the OIG has not made initial or reconsidered determinations on 
them, and even if they arose after the request for hearing was filed or 
after the prehearing conference.
    (3) The ALJ may give notice of hearing on new issues at any time 
after the hearing request is filed and before the hearing record is 
closed.
    (b) Time limits. The ALJ will not consider any issue that arose on 
or after any of the following dates:
    (1) The effective date of the termination of a provider agreement.
    (2) The date on which it is determined that a supplier no longer 
meets the conditions for coverage of its services.
    (3) The effective date of the notice to a hospital of its failure to 
remain in compliance with the qualifications for claiming reimbursement 
for all emergency services furnished to Medicare beneficiaries during 
the calendar year.
    (4) The effective date of the suspension, or of the exclusion from 
coverage of services furnished by a suspended or excluded practitioner, 
provider, or supplier.
    (5) With respect to Medicaid SNFs or ICFs surveyed under section 
1910(c) of the Act--
    (i) The completion date of the survey or resurvey that is the basis 
for a proposed cancellation of approval; or
    (ii) If approval was cancelled before the hearings, because of 
immediate and serious threat to patient health and safety, the effective 
date of cancellation.
    (c) Notice and conduct of hearing on new issues. (1) Unless the 
affected party waives its right to appear and present evidence, notice 
of the time and place of hearing on any new issue will be given to the 
parties in accordance with Sec. 498.52.

[[Page 890]]

    (2) After giving notice, the ALJ will, except as provided in 
paragraph (d) of this section, proceed to hearing on new issues in the 
same manner as on an issue raised in the request for hearing.
    (d) Remand to CMS or the OIG. At the request of either party, or on 
his or her own motion, in lieu of a hearing under paragraph (c) of this 
section, the ALJ may remand the case to CMS or the OIG for consideration 
of the new issue and, if appropriate, a determination. If necessary, the 
ALJ may direct CMS or the OIG to return the case to the ALJ for further 
proceedings.
    (e) Provider and supplier enrollment appeals: Good cause 
requirement--(1) Examination of any new documentary evidence. After a 
hearing is requested but before it is held, the ALJ will examine any new 
documentary evidence submitted to the ALJ by a provider or supplier to 
determine whether the provider or supplier has good cause for submitting 
the evidence for the first time at the ALJ level.
    (2) Determining if good cause exists--(i) If good cause exists. If 
the ALJ finds that there is good cause for submitting new documentary 
evidence for the first time at the ALJ level, the ALJ must include 
evidence and may consider it in reaching a decision.
    (ii) If good cause does not exist. If the ALJ determines that there 
was not good cause for submitting the evidence for the first time at the 
ALJ level, the ALJ must exclude the evidence from the proceeding and may 
not consider it in reaching a decision.
    (2) Notification to all parties. As soon as possible, but no later 
than the start of the hearing, the ALJ must notify all parties of any 
evidence that is excluded from the hearing.

[52 FR 22446, June 12, 1987, as amended at 53 FR 31335, Aug. 18, 1988; 
73 FR 36463, June 27, 2008]



Sec. 498.58  Subpoenas.

    (a) Basis for issuance. The ALJ, upon his or her own motion or at 
the request of a party, may issue subpoenas if they are reasonably 
necessary for the full presentation of a case.
    (b) Timing of request by a party. The party must file a written 
request for a subpoena with the ALJ at least 5 days before the date set 
for the hearing.
    (c) Content of request. The request must:
    (1) Identify the witnesses or documents to be produced;
    (2) Describe their addresses or location with sufficient 
particularity to permit them to be found; and
    (3) Specify the pertinent facts the party expects to establish by 
the witnesses or documents, and indicate why those facts could not be 
established without use of a subpoena.
    (d) Method of issuance. Subpoenas are issued in the name of the 
Secretary, who pays the cost of issuance and the fees and mileage of any 
subpoenaed witnesses.



Sec. 498.60  Conduct of hearing.

    (a) Participants in the hearing. The hearing is open to the parties 
and their representatives and technical advisors, and to any other 
persons whose presence the ALJ considers necessary or proper.
    (b) Hearing procedures. (1) The ALJ inquires fully into all of the 
matters at issue, and receives in evidence the testimony of witnesses 
and any documents that are relevant and material.
    (2) If the ALJ believes that there is relevant and material evidence 
available which has not been presented at the hearing, he may, at any 
time before mailing of notice of the decision, reopen the hearing to 
receive that evidence.
    (3) The ALJ decides the order in which the evidence and the 
arguments of the parties are presented and the conduct of the hearing.
    (c) Scope of review: Civil money penalty. In civil money penalty 
cases--
    (1) The scope of review is as specified in Sec. Sec. 488.438(e) and 
488.845(h) of this chapter; and
    (2) CMS' determination as to the level of noncompliance of a SNF, 
NF, or HHA must be upheld unless it is clearly erroneous.

[52 FR 22446, June 12, 1987, as amended at 61 FR 32350, June 24, 1996; 
79 FR 66118, Nov. 6, 2014]



Sec. 498.61  Evidence.

    Evidence may be received at the hearing even though inadmissible 
under the rules of evidence applicable

[[Page 891]]

to court procedure. The ALJ rules on the admissibility of evidence.

[59 FR 56252, Nov. 10, 1994, as amended at 61 FR 32350, June 24, 1996]



Sec. 498.62  Witnesses.

    Witnesses at the hearing testify under oath or affirmation. The 
representative of each party is permitted to examine his or her own 
witnesses subject to interrogation by the representative of the other 
party. The ALJ may ask any questions that he or she deems necessary. The 
ALJ rules upon any objection made by either party as to the propriety of 
any question.



Sec. 498.63  Oral and written summation.

    The parties to a hearing are allowed a reasonable time to present 
oral summation and to file briefs or other written statements of 
proposed findings of fact and conclusions of law. Copies of any briefs 
or other written statements must be sent in accordance with Sec. 
498.17.



Sec. 498.64  Record of hearing.

    A complete record of the proceedings at the hearing is made and 
transcribed in all cases.



Sec. 498.66  Waiver of right to appear and present evidence.

    (a) Waiver procedures. (1) If an affected party wishes to waive its 
right to appear and present evidence at the hearing, it must file a 
written waiver with the ALJ.
    (2) If the affected party wishes to withdraw a waiver, it may do so, 
for good cause, at any time before the ALJ mails notice of the hearing 
decision.
    (b) Effect of waiver. If the affected party waives the right to 
appear and present evidence, the ALJ need not conduct an oral hearing 
except in one of the following circumstances:
    (1) The ALJ believes that the testimony of the affected party or its 
representatives or other witnesses is necessary to clarify the facts at 
issue.
    (2) CMS or the OIG shows good cause for requiring the presentation 
of oral evidence.
    (c) Dismissal for failure to appear. If, despite the waiver, the ALJ 
sends notice of hearing and the affected party fails to appear, or to 
show good cause for the failure, the ALJ will dismiss the appeal in 
accordance with Sec. 498.69.
    (d) Hearing without oral testimony. When there is no oral testimony, 
the ALJ will--
    (1) Make a record of the relevant written evidence that was 
considered in making the determination being appealed, and of any 
additional evidence submitted by the parties;
    (2) Furnish to each party copies of the additional evidence 
submitted by the other party; and
    (3) Give both parties a reasonable opportunity for rebuttal.
    (e) Handling of briefs and related statements. If the parties submit 
briefs or other written statements of evidence or proposed findings of 
facts or conclusions of law, those documents will be handled in 
accordance with Sec. 498.17.



Sec. 498.68  Dismissal of request for hearing.

    (a) The ALJ may, at any time before mailing the notice of the 
decision, dismiss a hearing request if a party withdraws its request for 
a hearing or the affected party asks that its request be dismissed.
    (b) An affected party may request a dismissal by filing a written 
notice with the ALJ.



Sec. 498.69  Dismissal for abandonment.

    (a) The ALJ may dismiss a request for hearing if it is abandoned by 
the party that requested it.
    (b) The ALJ may consider a request for hearing to be abandoned if 
the party or its representative--
    (1) Fails to appear at the prehearing conference or hearing without 
having previously shown good cause for not appearing; and
    (2) Fails to respond, within 10 days after the ALJ sends a ``show 
cause'' notice, with a showing of good cause.



Sec. 498.70  Dismissal for cause.

    On his or her own motion, or on the motion of a party to the 
hearing, the ALJ may dismiss a hearing request either entirely or as to 
any stated issue, under any of the following circumstances:
    (a) Res judicata. There has been a previous determination or 
decision with

[[Page 892]]

respect to the rights of the same affected party on the same facts and 
law pertinent to the same issue or issues which has become final either 
by judicial affirmance or, without judicial consideration, because the 
affected party did not timely request reconsideration, hearing, or 
review, or commence a civil action with respect to that determination or 
decision.
    (b) No right to hearing. The party requesting a hearing is not a 
proper party or does not otherwise have a right to a hearing.
    (c) Hearing request not timely filed. The affected party did not 
file a hearing request timely and the time for filing has not been 
extended.



Sec. 498.71  Notice and effect of dismissal and right to request 
review.

    (a) Notice of the ALJ's dismissal action is mailed to the parties. 
The notice advises the affected party of its right to request that the 
dismissal be vacated as provided in Sec. 498.72.
    (b) The dismissal of a request for hearing is binding unless it is 
vacated by the ALJ or the Departmental Appeals Board.



Sec. 498.72  Vacating a dismissal of request for hearing.

    An ALJ may vacate any dismissal of a request for hearing if a party 
files a request to that effect within 60 days from receipt of the notice 
of dismissal and shows good cause for vacating the dismissal. (Date of 
receipt is determined in accordance with Sec. 498.22(b)(3).)



Sec. 498.74  Administrative Law Judge's decision.

    (a) Timing, basis and content. As soon as practical after the close 
of the hearing, the ALJ issues a written decision in the case. The 
decision is based on the evidence of record and contains separate 
numbered findings of fact and conclusions of law.
    (b) Notice and effect. A copy of the decision is mailed to the 
parties and is binding on them unless--
    (1) A party requests review by the Departmental Appeals Board within 
the time period specified in Sec. 498.82, and the Board reviews the 
case;
    (2) The Departmental Appeals Board denies the request for review and 
the party seeks judicial review by filing an action in a United States 
District Court or, in the case of a civil money penalty, in a United 
States Court of Appeals;
    (3) The decision is revised by an ALJ or the Departmental Appeals 
Board; or
    (4) The decision is a recommended decision directed to the Board.

[52 FR 22446, June 12, 1987, as amended at 61 FR 32351, June 24, 1996]



Sec. 498.76  Removal of hearing to Departmental Appeals Board.

    (a) At any time before the ALJ receives oral testimony, the Board 
may remove to itself any pending request for a hearing.
    (b) Notice of removal is mailed to each party.
    (c) The Board conducts the hearing in accordance with the rules that 
apply to ALJ hearings under this subpart.



Sec. 498.78  Remand by the Administrative Law Judge.

    (a) If CMS requests a remand, the ALJ may remand any case properly 
before him or her to CMS.
    (b) The ALJ may remand at any time before notice of hearing decision 
is mailed.

[52 FR 22446, June 12, 1987, as amended at 73 FR 36463, June 27, 2008]



Sec. 498.79  Timeframes for deciding an enrollment appeal before
an ALJ.

    When a request for an ALJ hearing is filed after CMS or a FFS 
contractor has denied an enrollment application, the ALJ must issue a 
decision, dismissal order or remand to CMS, as appropriate, no later 
than the end of the 180-day period beginning from the date the appeal 
was filed with an ALJ.

[73 FR 36463, June 27, 2008]



               Subpart E_Departmental Appeals Board Review



Sec. 498.80  Right to request Departmental Appeals Board review
of Administrative Law Judge's decision or dismissal.

    Either of the parties has a right to request Departmental Appeals 
Board

[[Page 893]]

review of the ALJ's decision or dismissal order, and the parties are so 
informed in the notice of the ALJ's action.



Sec. 498.82  Request for Departmental Appeals Board review.

    (a) Manner and time of filing. (1) Any party that is dissatisfied 
with an ALJ's decision or dismissal of a hearing request, may file a 
written request for review by the Departmental Appeals Board.
    (2) The requesting party or its representative or other authorized 
official must file the request with the OHA within 60 days from receipt 
of the notice of decision or dismissal, unless the Board, for good cause 
shown by the requesting party, extends the time for filing. The rules 
set forth in Sec. 498.40(c) apply to extension of time for requesting 
Departmental Appeals Board review. (The date of receipt of notice is 
determined in accordance with Sec. 498.22(c)(3).)
    (b) Content of request for review. A request for review of an ALJ 
decision or dismissal must specify the issues, the findings of fact or 
conclusions of law with which the party disagrees, and the basis for 
contending that the findings and conclusions are incorrect.



Sec. 498.83  Departmental Appeals Board action on request for review.

    (a) Request by CMS or the OIG. The Departmental Appeals Board may 
dismiss, deny, or grant a request made by CMS or the OIG for review of 
an ALJ decision or dismissal.
    (b) Request by the affected party. The Board will grant the affected 
party's request for review unless it dismisses the request for one of 
the following reasons:
    (1) The affected party requests dismissal of its request for review.
    (2) The affected party did not file timely or show good cause for 
late filing.
    (3) The affected party does not have a right to review.
    (4) A previous determination or decision, based on the same facts 
and law, and regarding the same issue, has become final through judicial 
affirmance or because the affected party failed to timely request 
reconsideration, hearing, Board review, or judicial review, as 
appropriate.
    (c) Effect of dismissal. The dismissal of a request for Departmental 
Appeals Board review is binding and not subject to further review.
    (d) Review panel. If the Board grants a request for review of the 
ALJ's decision, the review will be conducted by a panel of at least two 
members of the Board, designated by the Chairperson or Deputy 
Chairperson, and one individual designated by the Secretary from the U.S 
Public Health Service.



Sec. 498.85  Procedures before the Departmental Appeals Board on review.

    The parties are given, upon request, a reasonable opportunity to 
file briefs or other written statements as to fact and law, and to 
appear before the Departmental Appeals Board to present evidence or oral 
arguments. Copies of any brief or other written statement must be sent 
in accordance with Sec. 498.17.



Sec. 498.86  Evidence admissible on review.

    (a) Except for provider or supplier enrollment appeals, the Board 
may admit evidence into the record in addition to the evidence 
introduced at the ALJ hearing (or the documents considered by the ALJ if 
the hearing was waived) if the Board considers that the additional 
evidence is relevant and material to an issue before it.
    (b) If it appears to the Board that additional relevant evidence is 
available, the Board will require that it be produced.
    (c) Before additional evidence is admitted into the record--
    (1) Notice is mailed to the parties (unless they have waived notice) 
stating that evidence will be received regarding specified issues; and
    (2) The parties are given a reasonable time to comment and to 
present other evidence pertinent to the specified issues.
    (d) If additional evidence is presented orally to the Board, a 
transcript is prepared and made available to any party upon request.

[52 FR 22446, June 12, 1987, as amended at 73 FR 36463, June 27, 2008]

[[Page 894]]



Sec. 498.88  Decision or remand by the Departmental Appeals Board.

    (a) When the Departmental Appeals Board reviews an ALJ's decision or 
order of dismissal, or receives a case remanded by a court, the Board 
may either issue a decision or remand the case to an ALJ for a hearing 
and decision or a recommended decision for final decision by the Board.
    (b) In a remanded case, the ALJ initiates additional proceedings and 
takes other actions as directed by the Board in its order of remand, and 
may take other action not inconsistent with that order.
    (c) Upon completion of all action called for by the remand order and 
any other consistent action, the ALJ promptly makes a decision or, as 
specified by the Board, certifies the case to the Board with a 
recommended decision.
    (d) The parties have 20 days from the date of a notice of a 
recommended decision to submit to the Board any exception, objection, or 
comment on the findings of fact, conclusions of law, and recommended 
decision.
    (e) After the 20-day period, the Board issues its decision adopting, 
modifying or rejecting the ALJ's recommended decision.
    (f) If the Board does not remand the case to an ALJ, the following 
rules apply:
    (1) The Board's decision--
    (i) Is based upon the evidence in the hearing record and any further 
evidence that the Board receives during its review;
    (ii) Is in writing and contains separate numbered findings of fact 
and conclusions of law; and
    (iii) May modify, affirm, or reverse the ALJ's decision.
    (2) A copy of the Board's decision is mailed to each party.
    (g) When a request for Board review of a denial of an enrollment 
application is filed after an ALJ has issued a decision or dismissal 
order, the Board must issue a decision, dismissal order or remand to the 
ALJ, as appropriate, no later than 180 days after the appeal was 
received by the Board.

[52 FR 22446, June 12, 1987, as amended at 73 FR 36463, June 27, 2008]



Sec. 498.90  Effect of Departmental Appeals Board decision.

    (a) General rule. The Board's decision is binding unless--
    (1) The affected party has a right to judicial review and timely 
files a civil action in a United States District Court or, in the case 
of a civil money penalty, in a United States Court of Appeals; or
    (2) The Board reopens and revises its decision in accordance with 
Sec. 498.102.
    (b) Right to judicial review. Section 498.5 specifies the 
circumstances under which an affected party has a right to seek judicial 
review.
    (c) Special rules: Civil money penalty--(1) Finality of Board's 
decision. When CMS imposes a civil money penalty, notice of the Board's 
decision (or denial of review) is the final administrative action that 
initiates the 60-day period for seeking judicial review.
    (2) Timing for collection of civil money penalty. For SNFs and NFs, 
the rules that apply are those set forth in subpart F of part 488 of 
this chapter.

[61 FR 32351, June 24, 1996]



Sec. 498.95  Extension of time for seeking judicial review.

    (a) Any affected party that is dissatisfied with an Departmental 
Appeals Board decision and is entitled to judicial review must commence 
civil action within 60 days from receipt of the notice of the Board's 
decision (as determined under Sec. 498.22(c)(3)), unless the Board 
extends the time in accordance with paragraph (c) of this section.
    (b) The request for extension must be filed in writing with the 
Board before the 60-day period ends.
    (c) For good cause shown, the Board may extend the time for 
commencing civil action.



 Subpart F_Reopening of Decisions Made by Administrative Law Judges or 
                     the Departmental Appeals Board



Sec. 498.100  Basis, timing, and authority for reopening an ALJ
or Board decision.

    (a) Basis and timing for reopening. An ALJ of Departmental Appeals 
Board decision may be reopened, within 60

[[Page 895]]

days from the date of the notice of decision, upon the motion of the ALJ 
or the Board or upon the petition of either party to the hearing.
    (b) Authority to reopen. (1) A decision of the Departmental Appeals 
Board may be reopened only by the Departmental Appeals Board.
    (2) A decision of an ALJ may be reopened by that ALJ, by another ALJ 
if that one is not available, or by the Departmental Appeals Board. For 
purposes of this paragraph, an ALJ is considered to be unavailable if 
the ALJ has died, terminated employment, or been transferred to another 
duty station, is on leave of absence, or is unable to conduct a hearing 
because of illness.



Sec. 498.102  Revision of reopened decision.

    (a) Revision based on new evidence. If a reopened decision is to be 
revised on the basis of new evidence that was not included in the record 
of that decision, the ALJ or the Departmental Appeals Board--
    (1) Notifies the parties of the proposed revision; and
    (2) Unless the parties waive their right to hearing or appearance--
    (i) Grants a hearing in the case of an ALJ revision; and
    (ii) Grants opportunity to appear in the case of a Board revision.
    (b) Basis for revised decision and right to review. (1) If a revised 
decision is necessary, the ALJ or the Departmental Appeals Board, as 
appropriate, renders it on the basis of the entire record.
    (2) If the decision is revised by an ALJ, the Departmental Appeals 
Board may review that revised decision at the request of either party or 
on its own motion.



Sec. 498.103  Notice and effect of revised decision.

    (a) Notice. The notice mailed to the parties states the basis or 
reason for the revised decision and informs them of their right to 
Departmental Appeals Board review of an ALJ revised decision, or to 
judicial review of a Board reviewed decision.
    (b) Effect--(1) ALJ revised decision. An ALJ revised decision is 
binding unless it is reviewed by the Departmental Appeals Board.
    (2) Departmental Appeals Board revised decision. A Board revised 
decision is binding unless a party files a civil action in a district 
court of the United States within the time frames specified in Sec. 
498.95.

[[Page 896]]



       SUBCHAPTER H_HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS





PART 505_ESTABLISHMENT OF THE HEALTH CARE INFRASTRUCTURE IMPROVEMENT
PROGRAM--Table of Contents



                         Subpart A_Loan Criteria

Sec.
505.1 Basis and scope.
505.3 Definitions.
505.5 Loan criteria.
505.7 Terms of the loan.
505.9 State and local permits.
505.11 Loan application requirements and procedures.

                  Subpart B_Forgiveness of Indebtedness

505.13 Conditions for loan forgiveness.
505.15 Plan criteria for meeting the conditions for loan forgiveness.
505.17 Reporting requirements for meeting the conditions for loan 
          forgiveness.
505.19 Approval or denial of loan forgiveness.

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

    Source: 70 FR 57374, Sept. 30, 2005, unless otherwise noted.



                         Subpart A_Loan Criteria



Sec. 505.1  Basis and scope.

    This part implements section 1016 of the Medicare Prescription Drug, 
Improvement and Modernization Act of 2003 (MMA) which amends section 
1897 of the Act. Section 1897 of the Act as amended by section 6045 of 
the Tsunami Relief Act of 2005 authorizes the Secretary to establish a 
loan program by which qualifying hospitals may apply for a loan for the 
capital costs of the health care infrastructure improvement projects. 
Section 1897 of the Act appropriates $142,000,000 for the loan program 
including program administration. The funds are available beginning July 
1, 2004 through September 30, 2008. This part sets forth the criteria 
that CMS uses to select among qualifying hospitals.



Sec. 505.3  Definitions.

    For purposes of this subpart, the following definitions apply:
    Eligible project means the project of a qualifying hospital that is 
designed to improve the health care infrastructure of the hospital, 
including construction, renovation, or other capital improvements.
    Entity is an entity described in section 501(c)(3) of the Internal 
Revenue Code of 1986 and exempt from tax under section 501(a) of the 
code. An entity must also have at least one existing memorandum of 
understanding or affiliation agreement with a hospital located in the 
State in which the entity is located and retains clinical outpatient 
treatment for cancer on site as well as laboratory research, education, 
and outreach for cancer in the same facility.
    Outreach programs mean formal cancer programs for teaching, 
diagnostic screening, therapy or treatment, prevention, or interventions 
to enhance the health and knowledge of their designated population(s).
    Qualifying hospital means a hospital as defined at section 1861(e) 
of the Act (42 U.S,C. 1395x(e)) or an entity (as defined in this 
section) that is engaged in research in the causes, prevention, and 
treatment of cancer; and is either designated as a cancer center for the 
National Cancer Institute; or designated by the State legislature as the 
official cancer institute of the State before December 8, 2003.
    Unique research resources means resources that are used for the 
purpose of discovering or testing options related to the causes, 
prevention, and treatment of cancer.

[70 FR 57374, Sept. 30, 2005, as amended at 71 FR 48143, Aug. 18, 2006]



Sec. 505.5  Loan criteria.

    (a) Qualifying criteria. To qualify for the loan program, the 
applicant must meet the following conditions:
    (1) Meet the definition of a ``qualifying hospital'' as set forth in 
Sec. 505.3 of this part.
    (2) Request a loan for the capital costs of an ``eligible project'' 
as defined in Sec. 505.3 of this part. The capital costs

[[Page 897]]

for which a qualifying hospital may obtain a loan are limited to the 
reasonable costs incurred by the hospital, and capitalized on the 
Medicare cost report, for any facility or item of equipment that it has 
acquired the possession or use of at the time the loan funding is 
awarded.
    (b) Selection criteria. In selecting loan beneficiaries, CMS 
prioritizes qualifying hospitals that meet the following criteria:
    (1) The hospital is located in a State that, based on population 
density, is defined as a rural State. A rural State is one of ten States 
with the lowest population density. An applicant entity is required to 
be located in one of these ten States. The ten States are prioritized 
beginning with the State with the lowest population density. Population 
density is determined based on the most recent available U.S. Census 
Bureau data.
    (2) The hospital is located in a State with multiple Indian tribes 
in the State. After prioritizing based on paragraph (b)(1) of this 
section, States are further prioritized based on the States with the 
most Indian tribes. The number of Indian tribes in a State is based on 
the most recent data available published in ``Indian Entities Recognized 
and Eligible to Receive Services from the United State Bureau of Indian 
Affairs.'' (68 FR 68180) published on December 5, 2003.
    (c) CMS will send written notice to qualifying hospitals that have 
been selected to participate in the loan program under this part.



Sec. 505.7  Terms of the loan.

    All loan beneficiaries must agree to the following loan terms:
    (a) Loan obligation. An authorized official of a qualifying hospital 
must execute a promissory note, loan agreement, or a form approved by 
CMS and accompanied by any other documents CMS may designate. The loan 
beneficiary must provide required documentation in a timely manner.
    (b) Schedule of loan. A loan beneficiary receives a lump sum 
distribution for which payment of principal and interest is deferred for 
60 months beginning with the day of award notification from CMS. The 
loan repayment period is 20 years.
    (c) Bankruptcy protection. In the event a loan beneficiary files for 
bankruptcy protection in a court of competent jurisdiction or otherwise 
proves to be insolvent, CMS may terminate the deferment period described 
in paragraph (b) of this section and require immediate payment of the 
loan. If a loan beneficiary should file for bankruptcy protection in a 
court of competent jurisdiction or should otherwise evidence insolvency 
after the deferment period we will require immediate repayment of the 
outstanding principal and interest due. Those payments may be deducted 
from any Medicare payments otherwise due that hospital.
    (d) Loan forgiveness. CMS does not require a loan beneficiary to 
begin making payments of principal or interest at the end of the 60-
month deferment period if it determines that the loan beneficiary meets 
the criteria for loan forgiveness under section 1897 of the Act, as 
determined by the Secretary.
    (e) Default. If a loan beneficiary fails to make any payment in 
repayment of a loan under this subpart within 10 days of its due date, 
the loan beneficiary may be considered to have defaulted on the loan. 
Upon default, all principal and accrued interest become due immediately, 
and CMS may require immediate payment of any outstanding principal and 
interest due. Those payments may be deducted from any Medicare payments 
otherwise due that hospital.
    (f) Loan repayment. The loan beneficiary must meet the following 
conditions:
    (1) Make payments every month for 20 years until the loan, including 
interest payments, are paid in full.
    (2) Pay interest on the unpaid principal until the full amount of 
principal has been paid.
    (3) Pay interest at a yearly rate based upon the rate as fixed by 
the Secretary of the Treasury and set forth at 45 CFR 30.13(a).
    (4) If a loan beneficiary fails to make any payment in repayment of 
a loan under this subpart within 10 days of its

[[Page 898]]

due date, that payment may be deducted from any Medicare payments 
otherwise due to the beneficiary.
    (g) Interest rate and monthly payment charges. CMS calculates 
interest charges and payments consistent with Sec. 405.378 of this 
chapter.
    (h) Loan recipient's right to prepay. A loan beneficiary has the 
right to make payments of principal at any time before they are due. A 
loan beneficiary may make full prepayment or partial prepayment without 
paying any prepayment charge. If a prepayment is made, the loan 
beneficiary must provide written notice to CMS at CMS, Division of 
Accounting Operations, P.O. Box 75120, Baltimore, MD 21207-0520.



Sec. 505.9  State and local permits.

    With respect to an eligible project, the provision of a loan under 
this part shall not--
    (a) Relieve the beneficiary of the loan or any obligation to obtain 
any required State or local permit or approval with respect to the 
project.
    (b) Limit the right of any unit of State or local government to 
approve or regulate any rate of return on private equity invested in the 
project.
    (c) Supersede any State or local law (including any regulation) 
applicable to the construction or operation of the project.



Sec. 505.11  Loan application requirements and procedures.

    (a) The loan application must be received by CMS no later than 5 
p.m. e.d.t. on December 29, 2005.
    (b) The requested information must be typed or clearly printed in 
ink and the loan beneficiary must mail or deliver an original copy of 
the loan to CMS. The loan application must contain the following 
information:
    (1) Qualifying hospital's name and street address.
    (2) Qualifying hospital's Medicare provider number.
    (3) Name, title, and telephone number of a contact person submitting 
the application.
    (4) Provide all appropriate supporting documentation for each answer 
made on the loan application.



                  Subpart B_Forgiveness of Indebtedness

    Source: 71 FR 48144, Aug. 18, 2006, unless otherwise noted.



Sec. 505.13  Conditions for loan forgiveness.

    The Secretary may forgive a loan provided under this part if the 
qualifying hospital--
    (a) Has been selected to participate in the loan program specified 
in Sec. 505.5(c).
    (b) Has established the following in accordance with a plan that 
meets the criteria specified in Sec. 505.15:
    (1) An outreach program for cancer prevention, early diagnosis, and 
treatment that provides services to a substantial majority of the 
residents of a State or region, including residents of rural areas;
    (2) An outreach program for cancer prevention, early diagnosis, and 
treatment that provides services to multiple Indian tribes; and
    (3) Unique research resources (such as population databases) or an 
affiliation with an entity that has unique research resources.
    (c) Submits to CMS, within the timeframe specified by the Secretary, 
a--
    (1) Written request for loan forgiveness; and
    (2) Loan forgiveness plan that meets the criteria specified in Sec. 
505.15 of this subpart.



Sec. 505.15  Plan criteria for meeting the conditions for loan
forgiveness.

    The qualifying hospital requesting loan forgiveness must submit to 
CMS a plan specifying how it will develop, implement, or maintain an 
existing outreach program for cancer prevention, early diagnosis, and 
treatment for a substantial majority of the residents of a State or 
region, including residents of rural areas and for multiple Indian 
tribes and specifying how the qualifying hospital will establish or 
maintain existing unique research resources or an affiliation with an 
entity that has unique research resources.
    (a) Outreach programs. The initial plan must specify how the 
hospital will establish or develop, implement, or

[[Page 899]]

maintain existing outreach programs. The plan must--
    (1) Address cancer prevention for cancers that are prevalent in the 
designated populations or cancers that are targeted by the qualifying 
hospital, interventions, and goals for decreasing the targeted cancer 
rates during the loan deferment program; and
    (2) Address early diagnosis of cancers that are prevalent in the 
designated populations or cancers that are targeted by the qualifying 
hospital, interventions, and goals for improving early diagnosis rates 
for the targeted cancer(s) during the loan deferment period;
    (3) Address cancer treatment for cancers that are prevalent in the 
designated populations or cancers that are targeted by the qualifying 
hospital, interventions, and goals for improving cancer treatment rates 
for the targeted cancer(s) during the loan deferment; and
    (4) Identify the measures that will be used to determine the 
qualifying hospital's annual progress in meeting the initial goals 
specified in paragraphs (a)(1) through (a)(3) of this section.
    (b) Unique research resources. The plan must specify how the 
qualifying hospital will establish or maintain existing unique research 
resources or an affiliation with an entity that has unique research 
resources.



Sec. 505.17  Reporting requirements for meeting the conditions for
loan forgiveness.

    (a) Annual reporting requirements. On an annual basis, beginning one 
year from the date that CMS notified the qualifying hospital of the loan 
award, the qualifying hospital must submit a report to CMS that updates 
the plan specified in Sec. 505.15 by--
    (1) Describing the qualifying hospital's progress in meeting its 
initial plan goals;
    (2) Describing any changes to the qualifying hospital's initial plan 
goals; and
    (3) Including at least one measure used to track the qualifying 
hospital's progress in meeting its plan goals.
    (b) Review of annual reports. CMS will review each qualifying 
hospital's annual report to provide the hospital with feedback regarding 
its loan forgiveness status. If CMS determines that the annual report 
shows that the qualifying hospital has fulfilled the conditions, plan 
criteria, and reporting requirements for loan forgiveness specified in 
Sec. Sec. 505.13, 505.15, and 505.17, CMS will notify the qualifying 
hospital in writing that the loan is forgiven.
    (c) Final annual reporting requirements. A qualifying hospital must 
submit its final report to CMS at least 6 months before the end of the 
loan deferment period specified in Sec. 505.7(b).



Sec. 505.19  Approval or denial of loan forgiveness.

    (a) Approval of loan forgiveness. If CMS determines that a 
qualifying hospital has met the conditions, plan criteria, and reporting 
requirements for loan forgiveness specified in Sec. Sec. 505.13, 
505.15, and 505.17, CMS will send a written notification of approval for 
loan forgiveness to the qualifying hospital by the earlier of--
    (1) 30 days from the date of receipt of the annual report that shows 
the qualifying hospital has satisfied the requirements for loan 
forgiveness; or
    (2) 90 days before the end of the loan deferment period defined in 
Sec. 505.7(b).
    (b) Denial of loan forgiveness. If CMS determines that a qualifying 
hospital has not met the conditions, plan criteria, or reporting 
requirements for loan forgiveness specified in Sec. 505.13, Sec. 
505.15, or Sec. 505.17 of this part, CMS will send a written 
notification of denial of loan forgiveness to the qualifying hospital at 
least 30 days before the end of the loan deferment period defined in 
Sec. 505.7(b).



PART 510_COMPREHENSIVE CARE FOR JOINT REPLACEMENT MODEL--
Table of Contents



                      Subpart A_General Provisions

Sec.
510.1 Basis and scope.
510.2 Definitions.

 Subpart B_Comprehensive Care for Joint Replacement Program Participants

510.100 Episodes being tested.
510.105 Geographic areas.
510.110 Access to records and retention.
510.115 Voluntary participation election.

[[Page 900]]

510.120 CJR participant hospital CEHRT track requirements.

                       Subpart C_Scope of Episodes

510.200 Time periods, included and excluded services, and attribution.
510.205 Beneficiary inclusion criteria.
510.210 Determination of the episode.

                      Subpart D_Pricing and Payment

510.300 Determination of episode quality-adjusted target prices.
510.301 Determination of reconciliation target prices.
510.305 Determination of the NPRA and reconciliation process.
510.310 Appeals process.
510.315 Composite quality scores for determining reconciliation payment 
          eligibility and quality incentive payments.
510.320 Treatment of incentive programs or add-on payments under 
          existing Medicare payment systems.
510.325 Allocation of payments for services that straddle the episode.

  Subpart E_Quality Measures, Beneficiary Protections, and Compliance 
                               Enforcement

510.400 Quality measures and reporting.
510.405 Beneficiary choice and beneficiary notification.
510.410 Compliance enforcement.

       Subpart F_Financial Arrangements and Beneficiary Incentives

510.500 Sharing arrangements under the CJR model.
510.505 Distribution arrangements.
510.506 Downstream distribution arrangements.
510.510 Enforcement authority.
510.515 Beneficiary incentives under the CJR model.

                            Subpart G_Waivers

510.600 Waiver of direct supervision requirement for certain post-
          discharge home visits.
510.605 Waiver of certain telehealth requirements.
510.610 Waiver of SNF 3-day rule.
510.615 Waiver of certain post-operative billing restrictions.
510.620 Waiver of deductible and coinsurance that otherwise apply to 
          reconciliation payments or repayments.

Subparts H-J [Reserved]

                       Subpart K_Model Termination

510.900 Termination of the CJR model.

    Authority: 42 U.S.C. 1302, 1315a, and 1395hh.

    Source: 80 FR 73540, Nov. 24, 2015, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 510.1  Basis and scope.

    (a) Basis. This part implements the test of the Comprehensive Care 
for Joint Replacement model under section 1115A of the Act. Except as 
specifically noted in this part, the regulations under this part must 
not be construed to affect the payment, coverage, program integrity, or 
other requirements (such as those in parts 412 and 482 of this chapter) 
that apply to providers and suppliers under this chapter.
    (b) Scope. This part sets forth the following:
    (1) The participants in the Comprehensive Care for Joint Replacement 
model.
    (2) The episodes being tested in the model.
    (3) The methodology for pricing and payment under the model.
    (4) Quality performance standards and quality reporting 
requirements.
    (5) Safeguards to ensure preservation of beneficiary choice and 
beneficiary notification.



Sec. 510.2  Definitions.

    For the purposes of this part, the following definitions are 
applicable unless otherwise stated:
    ACO means an accountable care organization, as defined at Sec. 
425.20 of this chapter, that participates in the Shared Savings Program 
and is not in Track 3.
    ACO participant has the meaning set forth in Sec. 425.20 of this 
chapter.
    ACO provider/supplier has the meaning set forth in Sec. 425.20 of 
this chapter.
    Actual episode payment means the sum of standardized Medicare claims 
payments for the items and services that are included in the episode in 
accordance with Sec. 510.200(b), excluding the items and services 
described in Sec. 510.200(d).
    Age bracket risk adjustment factor means the coefficient of risk 
associated with a patient's age bracket, calculated as described in 
Sec. 510.301(a)(1).

[[Page 901]]

    Alignment payment means a payment from a CJR collaborator to a 
participant hospital under a sharing arrangement, for the sole purpose 
of sharing the participant hospital's responsibility for making 
repayments to Medicare.
    Anchor hospitalization means the initial hospital stay upon 
admission for a lower extremity joint replacement, for which the 
institutional claim is billed through the IPPS. Anchor hospitalization 
also includes an inpatient hospital admission within 3 days after an 
outpatient Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty 
(THA).
    Anchor procedure means a TKA or THA procedure that is permitted and 
paid for by Medicare when performed in a hospital outpatient department 
(HOPD) and billed through the OPPS, except when the beneficiary is 
admitted to an inpatient hospital stay within 3 days after the TKA or 
THA.
    Applicable discount factor means the discount percentage established 
by the participant hospital's quality category as determined in Sec. 
510.315 and that is applied to the episode benchmark price for purposes 
of determining a participant hospital's Medicare repayment in 
performance years 2 and 3.
    Area means, as defined in Sec. 400.200 of this chapter, the 
geographical area within the boundaries of a State, or a State or other 
jurisdiction, designated as constituting an area with respect to which a 
Professional Standards Review Organization or a Utilization and Quality 
Control Peer Review Organization has been or may be designated.
    BPCI stands for the Bundled Payment for Care Improvement initiative.
    BPCI Advanced stands for the Bundled Payments for Care Improvement 
Advanced Model.
    CCN stands for CMS certification number.
    CEC stands for Comprehensive ESRD Care Initiative.
    CEHRT means certified electronic health record technology that meets 
the requirements of 45 CFR 170.102. .
    CJR beneficiary means a beneficiary who meets the beneficiary 
inclusion criteria in Sec. 510.205 and who is in a CJR episode.
    CJR collaborator means an ACO or one of the following Medicare-
enrolled individuals or entities that enters into a sharing arrangement:
    (1) SNF.
    (2) HHA.
    (3) LTCH.
    (4) IRF.
    (5) Physician.
    (6) Nonphysician practitioner.
    (7) Therapist in private practice.
    (8) CORF.
    (9) Provider of outpatient therapy services.
    (10) Physician Group Practice (PGP).
    (11) Hospital.
    (12) CAH.
    (13) Non-Physician Provider Group Practice (NPPGP).
    (14) Therapy Group Practice (TGP).
    CJR-HCC condition count risk adjustment factor means the coefficient 
of risk associated with a patient's total number of CMS Hierarchical 
Condition Categories, calculated as described in Sec. 510.301(a)(1).
    CJR reconciliation report means the report prepared after each 
reconciliation that CMS provides to each participant hospital notifying 
the participant hospital of the outcome of the reconciliation.
    Collaboration agent means an individual or entity that is not a CJR 
collaborator and that is either of the following:
    (1) A member of a PGP, NPPGP, or TGP that has entered into a 
distribution arrangement with the same PGP, NPPGP, or TGP in which he or 
she is an owner or employee, and where the PGP, NPPGP, or TGP is a CJR 
collaborator.
    (2) An ACO participant or ACO provider/supplier that has entered 
into a distribution arrangement with the same ACO in which it is 
participating, and where the ACO is a CJR collaborator.
    Composite quality score means a score computed for each participant 
hospital to summarize the hospital's level of quality performance and 
improvement on specified quality measures as described in Sec. 510.315.
    Core-based statistical area (CBSA) means a statistical geographic 
entity consisting of the county or counties associated with at least one 
core (urbanized area or urban cluster) of at least

[[Page 902]]

10,000 population, plus adjacent counties having a high degree of social 
and economic integration with the core as measured through commuting 
ties with the counties containing the core.
    CORF stands for comprehensive outpatient rehabilitation facility.
    COVID-19 Diagnosis Code means any of the following ICD-10-CM 
diagnosis codes:
    (1) B97.29;
    (2) U07.1; or
    (3) Any other ICD-10-CM diagnosis code that is recommended by the 
Centers for Disease Control and Prevention for the coding of a confirmed 
case of COVID-19.
    Critical access hospital (CAH) means a hospital designated under 
subpart F of part 485 of this chapter.
    Distribution arrangement means a financial arrangement between a CJR 
collaborator that is an ACO, PGP, NPPGP, or TGP and a collaboration 
agent for the sole purpose of distributing some or all of a gainsharing 
payment received by the ACO, PGP, NPPGP, or TGP.
    Distribution payment means a payment from a CJR collaborator that is 
an ACO, PGP, NPPGP, or TGP to a collaboration agent, under a 
distribution arrangement, composed only of gainsharing payments.
    DME stands for durable medical equipment.
    Downstream collaboration agent means an individual who is not a CJR 
collaborator or a collaboration agent and who is a PGP member, an NPPGP 
member, or a TGP member that has entered into a downstream distribution 
arrangement with the same PGP, NPPGP, or TGP in which he or she is an 
owner or employee, and where the PGP, NPPGP, or TGP is a collaboration 
agent.
    Downstream distribution arrangement means a financial arrangement 
between a collaboration agent that is both a PGP, NPPGP, or TGP and an 
ACO participant and a downstream collaboration agent for the sole 
purpose of distributing some or all of a distribution payment received 
by the PGP, NPPGP, or TGP.
    Downstream distribution payment means a payment from a collaboration 
agent that is both a PGP, NPPGP, or TGP and an ACO participant to a 
downstream collaboration agent, under a downstream distribution 
arrangement, composed only of distribution payments.
    Dual-eligibility risk adjustment factor means the coefficient of 
risk associated with beneficiaries that are eligible for full Medicaid 
benefits or beneficiaries that are not eligible for full Medicaid 
benefits, calculated as described in Sec. 510.301(a)(1).
    EFT stands for electronic funds transfer.
    Episode benchmark price means a dollar amount assigned to CJR 
episodes based on historical episode payment data (3 years of historical 
Medicare payment data grouped into CJR episodes according to the episode 
definition as described in Sec. 510.200(b)) prior to the application of 
the effective discount factor or applicable discount factor, as 
described in Sec. 510.300(c).
    Episode of care (or Episode) means all Medicare Part A and B items 
and services described in Sec. 510.200(b) (and excluding the items and 
services described in Sec. 510.200(d)) that are furnished to a 
beneficiary described in Sec. 510.205 during the time period that 
begins with the beneficiary's admission to an anchor hospitalization or, 
on or after July 4, 2021, the date of admission to an anchor 
hospitalization or the date of the anchor procedure, as applicable, and 
ends on the 90th day after the following, as applicable:
    (1) The date of discharge from the anchor hospitalization (with the 
day of discharge itself being counted as the first day of the 90-day 
post-discharge period); or
    (2) The date of service for the anchor procedure.
    ESRD stands for end stage renal disease.
    Gainsharing payment means a payment from a participant hospital to a 
CJR collaborator, under a sharing arrangement, composed of only 
reconciliation payments or internal cost savings or both.
    HCAHPS stands for Hospital Consumer Assessment of Healthcare 
Providers and Systems.
    HCPCS stands for Healthcare Common Procedure Coding System.
    HHA means a Medicare-enrolled home health agency.

[[Page 903]]

    Historical episode payment means the expenditures for historical 
episodes that occurred during the historical period used to determine 
the episode benchmark price.
    Hospital means a provider subject to the prospective payment system 
specified in Sec. 412.1(a)(1) of this chapter.
    ICD-CM stands for International Classification of Diseases, Clinical 
Modification.
    Inpatient prospective payment systems (IPPS) means the payment 
systems for subsection (d) hospitals as defined in section 1886(d)(1)(B) 
of the Act.
    Internal cost savings means the measurable, actual, and verifiable 
cost savings realized by the participant hospital resulting from care 
redesign undertaken by the participant hospital in connection with 
providing items and services to beneficiaries within specific CJR 
episodes of care. Internal cost savings does not include savings 
realized by any individual or entity that is not the participant 
hospital.
    IPF stands for inpatient psychiatric facility.
    IRF stands for inpatient rehabilitation facility.
    Low-volume hospital means a hospital identified by CMS as having 
fewer than 20 LEJR episodes in total across the 3 historical years of 
data used to calculate the performance year 1 CJR episode target prices.
    Lower-extremity joint replacement (LEJR) means any procedure that is 
within MS-DRG 469 or 470, or, on or after October 1, 2020, MS-DRG 521 or 
522, including lower-extremity joint replacement procedures or 
reattachment of a lower extremity.
    LTCH stands for long-term care hospital.
    Mandatory MSA means an MSA designated by CMS as a mandatory 
participation MSA in accordance with Sec. 510.105(a).
    Medicare severity diagnosis-related group (MS-DRG) means, for the 
purposes of this model, the classification of inpatient hospital 
discharges updated in accordance with Sec. 412.10 of this chapter.
    Medicare-dependent, small rural hospital (MDH) means a specific type 
of hospital that meets the classification criteria specified under Sec. 
412.108 of this chapter.
    Member of the NPPGP or NPPGP member means a nonphysician 
practitioner or therapist who is an owner or employee of an NPPGP and 
who has reassigned to the NPPGP his or her right to receive Medicare 
payment.
    Member of the PGP or PGP member means a physician, nonphysician 
practitioner, or therapist who is an owner or employee of the PGP and 
who has reassigned to the PGP his or her right to receive Medicare 
payment.
    Member of the TGP or TGP member means a therapist who is an owner or 
employee of a TGP and who has reassigned to the TGP his or her right to 
receive Medicare payment.
    Metropolitan Statistical Area (MSA) means a core-based statistical 
area associated with at least one urbanized area that has a population 
of at least 50,000.
    Net payment reconciliation amount (NPRA) means the amount determined 
in accordance with Sec. 510.305(e) or (m).
    Nonphysician practitioner means (except for purposes of subpart G of 
this part) one of the following:
    (1) A physician assistant who satisfies the qualifications set forth 
at Sec. 410.74(a)(2)(i) and (ii) of this chapter.
    (2) A nurse practitioner who satisfies the qualifications set forth 
at Sec. 410.75(b) of this chapter.
    (3) A clinical nurse specialist who satisfies the qualifications set 
forth at Sec. 410.76(b) of this chapter.
    (4) A certified registered nurse anesthetist (as defined at Sec. 
410.69(b)).
    (5) A clinical social worker (as defined at Sec. 410.73(a)).
    (6) A registered dietician or nutrition professional (as defined at 
Sec. 410.134).
    NPI stands for National Provider Identifier.
    NPPGP means an entity that is enrolled in Medicare as a group 
practice, includes at least one owner or employee who is a nonphysician 
practitioner, does not include a physician owner or employee, and has a 
valid and active TIN.
    OIG stands for the Department of Health and Human Services Office of 
the Inspector General.
    OP THA/OP TKA means a total hip arthroplasty or total knee

[[Page 904]]

arthroplasty, respectively, for which the institutional claim is billed 
by the hospital through the OPPS.
    OPPS stands for the outpatient prospective payment system.
    PAC stands for post-acute care.
    Participant hospital means one of the following:
    (1) During performance years 1 and 2 of the CJR model and the period 
from January 1, 2018 to January 31, 2018 of performance year 3, a 
hospital (other than a hospital excepted under Sec. 510.100(b)) with a 
CCN primary address located in one of the geographic areas selected for 
participation in the CJR model in accordance with Sec. 510.105.
    (2) Between February 1, 2018 and September 30, 2021 a hospital 
(other than a hospital excepted under Sec. 510.100(b)) that is one of 
the following:
    (i) A hospital with a CCN primary address located in a mandatory MSA 
as of February 1, 2018 that is not a rural hospital or a low-volume 
hospital on that date.
    (ii) A hospital that is a rural hospital or low-volume hospital with 
a CCN primary address located in a mandatory MSA that makes an election 
to participate in the CJR model in accordance with Sec. 510.115.
    (iii) A hospital with a CCN primary address located in a voluntary 
MSA that makes an election to participate in the CJR model in accordance 
with Sec. 510.115.
    (3) Beginning October 1, 2021, a hospital that is not a rural 
hospital or a low-volume hospital as defined in Sec. 510.2, as of July 
4, 2021 (based on the date of the CMS notification letter and not the 
effective date of the rural reclassification, if applicable) with a CCN 
primary address located in a mandatory MSA.
    PBPM stands for per-beneficiary-per-month.
    Performance year means one of the years in which the CJR model is 
being tested. Performance years for the model correlate to calendar 
years with the exceptions of performance year 1, which is April 1, 2016 
through December 31, 2016, performance year 5, which is January 1, 2020 
through September 30, 2021, and performance year 6 which is October 1, 
2021 through December 31, 2022. For reconciliation purposes, performance 
year 5 is divided into two subsets, performance year subset 5.1 (January 
1, 2020 through December 31, 2020) and performance year subset 5.2 
(January 1, 2021 through September 30, 2021).
    PGP stands for physician group practice.
    Physician has the meaning set forth in section 1861(r) of the Act.
    Post-episode spending amount means the sum of Medicare Parts A and B 
payments for items and services that are furnished to a beneficiary 
within 30 days after the end of the beneficiary's episode.
    Provider of outpatient therapy services means an entity that is 
enrolled in Medicare as a provider of therapy services and furnishes one 
or more of the following:
    (1) Outpatient physical therapy services as defined in Sec. 410.60 
of this chapter.
    (2) Outpatient occupational therapy services as defined in Sec. 
410.59 of this chapter.
    (3) Outpatient speech-language pathology services as defined in 
Sec. 410.62 of this chapter.
    Quality-adjusted target price means the dollar amount assigned to 
CJR episodes as the result of adjusting the episode benchmark price by 
the participant hospital's effective discount factor or applicable 
discount factor based on the participant hospital's quality category, as 
described in Sec. Sec. 510.300(c) and 510.315(f).
    Quality improvement points are points that CMS adds to a participant 
hospital's composite quality score for a measure if the hospital's 
performance percentile on an individual quality measure for performance 
years 2 through 4 and 6 through 8, or for performance year subsets of 
performance year 5, increases from the previous performance year or 
performance year subset by at least 2 deciles on the performance 
percentile scale, as described in Sec. 510.315(d). For performance year 
1, CMS adds quality improvement points to a participant hospital's 
composite quality score for a measure if the hospital's performance 
percentile on an individual quality measure increases from the 
corresponding time period in the previous year by at least 2 deciles

[[Page 905]]

on the performance percentile scale, as described in Sec. 510.315(d).
    Quality performance points are points that CMS adds to a participant 
hospital's composite quality score for a measure based on the 
performance percentile scale and for successful data submission of 
patient-reported outcomes.
    Reconciliation payment means a payment made by CMS to a CJR 
participant hospital as determined in accordance with Sec. 510.305(f) 
or (l).
    Reconciliation target price means, for performance years 6 through 
8, the target price applied to an episode at reconciliation, as 
determined in accordance with Sec. 510.301.
    Region means one of the nine U.S. census divisions, as defined by 
the U.S. Census Bureau.
    Repayment amount means the amount owed by a participant hospital to 
CMS, as reflected on a reconciliation report.
    Rural hospital means an IPPS hospital that meets one of the 
following definitions:
    (1) Is located in a rural area as defined under Sec. 412.64 of this 
chapter.
    (2) Is located in a rural census tract defined under Sec. 
412.103(a)(1) of this chapter.
    (3) Has reclassified as a rural hospital under Sec. 412.103 of this 
chapter.
    Rural referral center (RRC) has the same meaning given this term 
under Sec. 412.96 of this chapter.
    Sharing arrangement means a financial arrangement between a 
participant hospital and a CJR collaborator for the sole purpose of 
making gainsharing payments or alignment payments under the CJR model.
    SNF stands for skilled nursing facility.
    Sole community hospital (SCH) means a hospital that meets the 
classification criteria specified in Sec. 412.92 of this chapter.
    TGP means an entity that is enrolled in Medicare as a therapy group 
in private practice, includes at least one owner or employee who is a 
therapist in private practice, does not include an owner or employee who 
is a physician or nonphysician practitioner, and has a valid and active 
TIN.
    Therapist means one of the following individuals as defined at Sec. 
484.4 of this chapter:
    (1) Physical therapist.
    (2) Occupational therapist.
    (3) Speech-language pathologist.
    Therapist in private practice means a therapist that--
    (1) Complies with the special provisions for physical therapists in 
private practice in Sec. 410.60(c) of this chapter;
    (2) Complies with the special provisions for occupational therapists 
in private practice in Sec. 410.59(c) of this chapter; or
    (3) Complies with the special provisions for speech-language 
pathologists in private practice in Sec. 410.62(c) of this chapter.
    TIN stands for taxpayer identification number.
    TKA/THA stands for total knee arthroplasty/total hip arthroplasty.
    Voluntary MSA means an MSA designated by CMS as a voluntary 
participation MSA in accordance with Sec. 510.105(a).

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 610, 611, Jan. 3, 2017; 
82 FR 57103, Dec. 1, 2017; 85 FR 19292, Apr. 6, 2020; 85 FR 71198, Nov. 
6, 2020; 86 FR 23569, May 3, 2021]



 Subpart B_Comprehensive Care for Joint Replacement Program Participants



Sec. 510.100  Episodes being tested.

    (a) Initiation of an episode. An episode is initiated when, with 
respect to a beneficiary described in Sec. 510.205--
    (1) The participant hospital admits the beneficiary for an anchor 
hospitalization; or
    (2) On or after July 4, 2021, an anchor procedure is performed at 
the participant hospital.
    (b) Exclusions. A hospital is excluded from being a participant 
hospital, but only so long as any of the following conditions apply:
    (1) The hospital is an episode initiator for an LEJR episode in the 
risk-bearing period of Models 2 or 4 of BPCI.
    (2) The hospital is participating in Model 1 of BPCI.
    (3) These exclusions cease to apply as of the date that the hospital 
no longer

[[Page 906]]

meets any of the conditions specified in this paragraph.

[80 FR 73540, Nov. 24, 2015, as amended at 86 FR 23570, May 3, 2021]



Sec. 510.105  Geographic areas.

    (a) General. The geographic areas for inclusion in the CJR model are 
obtained based on a stratified random sampling of certain MSAs in the 
United States.
    (1) All counties within each of the selected MSAs are selected for 
inclusion in the CJR model.
    (2) Beginning with performance year 3, the selected MSAs are 
designated as either mandatory participation MSAs or voluntary 
participation MSAs.
    (3) Beginning with performance year 6, only the 34 MSAs designated 
as mandatory participation MSAs as of performance year 3.
    (b) Stratification criteria. Geographic areas in the United States 
are stratified according to the characteristics that CMS determines are 
necessary to ensure that the model is tested on a broad range of 
different types of hospitals that may face different obstacles and 
incentives for improving quality and controlling costs.
    (c) Exclusions. CMS excludes from the selection of geographic areas 
MSAs that met the following criteria:
    (1) Had fewer than 400 episodes between July 1, 2013 and June 30, 
2014.
    (2) Had fewer than 400 non-Model 1, 2, or 4 BPCI episodes as of 
October 1, 2015.
    (3) Failed either or both of the following rules regarding 
participation in BPCI:
    (i) More than 50 percent of eligible episodes initiated in a BPCI 
Model 2 or 4 initiating hospital.
    (ii) More than 50 percent of eligible episodes that included SNF or 
HHA services, where the SNF or HHA services were furnished by a BPCI 
Model 3 initiating HHA or SNF.
    (4) For MSAs including both Maryland and non-Maryland counties, more 
than 50 percent of eligible episodes were initiated at a Maryland 
hospital.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 57103, Dec. 1, 2017; 86 
FR 23570, May 3, 2021]



Sec. 510.110  Access to records and retention.

    Participant hospitals, CJR collaborators, collaboration agents, 
downstream collaboration agents, and any other individuals or entities 
performing CJR activities must do all of the following:
    (a) Allow the Government, including CMS, OIG, HHS and the 
Comptroller General or their designees, scheduled and unscheduled access 
to all books, contracts, records, documents and other evidence 
(including data related to utilization and payments, quality criteria, 
billings, lists of CJR collaborators, sharing arrangements, distribution 
arrangements, downstream distribution arrangements and the documentation 
required under Sec. Sec. 510.500(d) and 510.525(c)) sufficient to 
enable the audit, evaluation, inspection or investigation of any of the 
following:
    (1) The individual's or entity's compliance with CJR model 
requirements.
    (2) The calculation, distribution, receipt, or recoupment of 
gainsharing payments, alignment payments, distribution payments, and 
downstream distribution payments.
    (3) The obligation to repay any reconciliation payments owed to CMS.
    (4) The quality of the services furnished to a CJR beneficiary 
during a CJR episode.
    (5) The sufficiency of CJR beneficiary notifications.
    (6) The accuracy of the CJR participant hospital's submissions under 
CEHRT use requirements.
    (b) Maintain all such books, contracts, records, documents, and 
other evidence for a period of 10 years from the last day of the 
participant hospital's participation in the CJR model or from the date 
of completion of any audit, evaluation, inspection, or investigation, 
whichever is later, unless--
    (1) CMS determines a particular record or group of records should be 
retained for a longer period and notifies the participant hospital at 
least 30 calendar days before the disposition date; or
    (2) There has been a dispute or allegation of fraud or similar fault 
against the participant hospital, CJR collaborator, collaboration 
agents, downstream collaboration agent, or any

[[Page 907]]

other individual or entity performing CJR activities in which case the 
records must be maintained for 6 years from the date of any resulting 
final resolution of the dispute or allegation of fraud or similar fault.

[82 FR 612, Jan. 3, 2017]



Sec. 510.115  Voluntary participation election.

    (a) General. To continue participation in performance year 3 and 
participate in performance year 4 and performance year 5, the following 
hospitals must submit a written participation election letter as 
described in paragraph (c) of this section during the voluntary 
participation election period specified in paragraph (b) of this 
section:
    (1) Hospitals (other than those excluded under Sec. 510.100(b)) 
with a CCN primary address in a voluntary MSA.
    (2) Low-volume hospitals with a CCN primary address in a mandatory 
MSA.
    (3) Rural hospitals with a CCN primary address in a mandatory MSA.
    (b) Voluntary participation election period. The voluntary 
participation election period begins on January 1, 2018 and ends on 
January 31, 2018.
    (c) Voluntary participation election letter. The voluntary 
participation election letter serves as the model participation 
agreement. CMS accepts the voluntary participation election letter if 
the letter meets all of the following criteria:
    (1) Includes the following:
    (i) Hospital name.
    (ii) Hospital address.
    (iii) Hospital CCN.
    (iv) Hospital contact name, telephone number, and email address.
    (v) Model name (that is, CJR model).
    (2) Includes a certification that the hospital will--
    (i) Comply with all applicable requirements of this part and all 
other laws and regulations applicable to its participation in the CJR 
model; and
    (ii) Submit data or information to CMS that is accurate, complete 
and truthful, including, but not limited to, the participation election 
letter and any quality data or other information that CMS uses in its 
reconciliation processes.
    (3) Is signed by the hospital administrator, CFO or CEO.
    (4) Is submitted in the form and manner specified by CMS.

[82 FR 57103, Dec. 1, 2017]



Sec. 510.120  CJR participant hospital CEHRT track requirements.

    (a) CJR CEHRT use. For performance years 2 through 8, CJR 
participant hospitals choose either of the following:
    (1) CEHRT use. Participant hospitals attest in a form and manner 
specified by CMS to their use of CEHRT as defined in Sec. 414.1305 of 
this chapter to document and communicate clinical care with patients and 
other health professionals.
    (2) No CEHRT use. Participant hospitals do not attest in a form and 
manner specified by CMS to their use of CEHRT as defined in Sec. 
414.1305 of this chapter to document and communicate clinical care with 
patients and other health professionals.
    (b) Clinician financial arrangements list. Each participant hospital 
that chooses CEHRT use as provided in paragraph (a)(1) of this section 
must submit to CMS a clinician financial arrangements list in a form and 
manner specified by CMS on a no more than quarterly basis. The list must 
include the following information on individuals and entities for the 
period of the CJR performance year specified by CMS:
    (1) CJR collaborators. For each physician, nonphysician 
practitioner, or therapist in private practice who is a CJR collaborator 
during the period of the CJR performance year specified by CMS:
    (i) The name, TIN, and NPI of the CJR collaborator.
    (ii) The start date and, if applicable, end date, for the sharing 
arrangement between the CJR participant hospital and the CJR 
collaborator.
    (2) Collaboration agents. For each physician, nonphysician 
practitioner, or therapist who is a collaboration agent during the 
period of the CJR performance year specified by CMS:
    (i) The name and TIN of the CJR collaborator and the name, TIN, and 
NPI of the collaboration agent.
    (ii) The start date and, if applicable, end date, for the 
distribution arrangement between the CJR collaborator and the 
collaboration agent.

[[Page 908]]

    (3) Downstream collaboration agents. For each physician, 
nonphysician practitioner, or therapist who is a downstream 
collaboration agent during the period of the CJR performance year 
specified by CMS--
    (i) The name and TIN of the CJR collaborator and the name and TIN of 
the collaboration agent and the name, TIN, and NPI of the downstream 
collaboration agent.
    (ii) The start date and, if applicable, end date, for the downstream 
distribution arrangement between the collaboration agent and the 
downstream collaboration agent.
    (c) Clinician engagement list. Each participant hospital that 
chooses CEHRT use as provided in paragraph (a)(1) of this section must 
submit to CMS a clinician engagement list in a form and manner specified 
by CMS on a no more than quarterly basis. This list must include the 
following information on individuals for the period of the performance 
year specified by CMS:
    (1) For each physician, nonphysician practitioner, or therapist who 
is not a CJR collaborator during the period of the CJR model performance 
year specified by CMS but who does have a contractual relationship with 
the participant hospital based at least in part on supporting the 
participant hospital's quality or cost goals under the CJR model during 
the period of the performance year specified by CMS:
    (i) The name, TIN, and NPI of the individual.
    (ii) The start date and, if applicable, the end date for the 
contractual relationship between the individual and participant 
hospital.
    (2) The CJR participant hospital must retain and provide access to 
the required documentation in accordance with Sec. 510.110.
    (d) Attestation to no individuals. If there are no individuals that 
meet the requirements to be reported, as specified in paragraphs (b)(1) 
through (3) or paragraph (c) of this section, the participant hospital 
must attest in a form and manner required by CMS that there are no 
individuals to report.
    (e) Documentation requirements. (1) Each participant hospital that 
chooses CEHRT use as provided in paragraph (a)(1) of this section must 
maintain documentation of their attestation to CEHRT use, clinician 
financial arrangements lists, and clinician engagement lists.
    (2) The participant hospital must retain and provide access to the 
required documentation in accordance with Sec. 510.110.

[82 FR 612, Jan. 3, 2017, as amended at 82 FR 57103, Dec. 1, 2017; 86 FR 
23570, May 3, 2021]



                       Subpart C_Scope of Episodes



Sec. 510.200  Time periods, included and excluded services, 
and attribution.

    (a) Time periods. All episodes must begin on or after April 1, 2016 
and end on or before December 31, 2024.
    (b) Included services. All Medicare Parts A and B items and services 
are included in the episode, except as specified in paragraph (d) of 
this section. These services include, but are not limited to, the 
following:
    (1) Physicians' services.
    (2) Inpatient hospital services (including hospital readmissions).
    (3) IPF services.
    (4) LTCH services.
    (5) IRF services.
    (6) SNF services.
    (7) HHA services.
    (8) Hospital outpatient services.
    (9) Outpatient therapy services.
    (10) Clinical laboratory services.
    (11) DME.
    (12) Part B drugs and biologicals.
    (13) Hospice services.
    (14) PBPM payments under models tested under section 1115A of the 
Act.
    (15) The surgeon's Part B claim for the LEJR procedure dated within 
the 3 days prior to an inpatient admission, if the LEJR procedure was 
performed at the participant hospital on an outpatient basis but the 
patient was subsequently admitted as an inpatient, resulting in an 
anchor hospitalization.
    (c) Episode attribution. All items and services included in the 
episode are attributed to the participant hospital at which the anchor 
hospitalization or anchor procedure, as applicable, occurs.
    (d) Excluded services. The following items, services, and payments 
are excluded from the episode:
    (1) Hemophilia clotting factors provided in accordance with Sec. 
412.115 of this chapter.

[[Page 909]]

    (2) New technology add-on payments, as defined in part 412, subpart 
F of this chapter.
    (3) Transitional pass-through payments for medical devices as 
defined in Sec. 419.66 of this chapter.
    (4) Items and services unrelated to the anchor hospitalization or 
the anchor procedure. Excluded services include, but are not limited, to 
the following:
    (i) Inpatient hospital admissions for MS-DRGs that group to the 
following categories of diagnoses:
    (A) Oncology.
    (B) Trauma medical.
    (C) Chronic disease surgical, such as prostatectomy.
    (D) Acute disease surgical, such as appendectomy.
    (ii) Medicare Part B services, as identified by the principal ICD-CM 
diagnosis code on the claim (based on the ICD-CM version in use during 
the performance year) that group to the following categories of 
diagnoses:
    (A) Acute disease diagnoses, such as severe head injury.
    (B) Certain chronic disease diagnoses, as specified by CMS on a 
diagnosis-by-diagnosis basis depending on whether the condition was 
likely to have been affected by the LEJR procedure and recovery period 
or whether substantial services were likely to be provided for the 
chronic condition during the episode. Such chronic disease diagnoses are 
posted on the CMS Web site and may be revised in accordance with 
paragraph (e) of this section.
    (iii) Certain PBPM payments under models tested under section 1115A 
of the Act. PBPM model payments that CMS determines to be primarily used 
for care coordination or care management services for clinical 
conditions in excluded categories of diagnoses, as described in this 
paragraph.
    (A) The list of excluded PBPM payments is posted on the CMS Web site 
and are revised in accordance with paragraph (e) of this section.
    (B) Notwithstanding the foregoing, all PBPM model payments funded 
from CMS' Innovation Center appropriation are excluded from the episode.
    (5) Certain incentive programs and add on payments under existing 
Medicare payment systems in accordance with Sec. 510.300(b)(6) of this 
chapter.
    (6) For performance years 1 through 4 and for performance year 
subsets 5.1 and 5.2, payments for otherwise included items and services 
in excess of 2 standard deviations above the mean regional episode 
payment in accordance with Sec. 510.300(b)(5).
    (7) For performance years 6 through 8 only, payments for otherwise 
included items and services in excess of the 99th percentile of regional 
spending, ranked within each region, for each of the four MS-DRG target 
price categories, as specified in Sec. 510.300(a)(1) and (6), for 
performance years 6 through 8, in accordance with Sec. 510.300(b)(5).
    (e) Updating the lists of excluded services. (1) The list of 
excluded MS-DRGs, ICD-CM diagnosis codes, and CMS model PBPM payments 
are posted on the CMS Web site.
    (2) For performance years 1 through 5 only, on an annual basis, or 
more frequently as needed, CMS updates the list of excluded services to 
reflect annual coding changes or other issues brought to CMS' attention.
    (3) For performance years 1 through 5 only, CMS applies the 
following standards when revising the list of excluded services for 
reasons other than to reflect annual coding changes:
    (i) Items or services that are directly related to the LEJR 
procedure or the quality or safety of LEJR care would be included in the 
episode.
    (ii) Items or services for chronic conditions that may be affected 
by the LEJR procedure or post-surgical care would be related and 
included in the episode.
    (iii) Items and services for chronic conditions that are generally 
not affected by the LEJR procedure or post-surgical care would be 
excluded from the episode.
    (iv) Items and services for acute clinical conditions not arising 
from existing, episode-related chronic clinical conditions or 
complications of LEJR surgery would be excluded from the episode.
    (v) PBPM payments under CMS models determined to be primarily used 
for care coordination or care management

[[Page 910]]

services for clinical conditions in excluded categories of diagnoses, as 
described in Sec. 510.200(d), would be excluded from the episode.
    (4) For performance years 1 through 5 only, CMS posts the following 
to the CMS website:
    (i) Potential revisions to the exclusion to allow for public 
comment; and
    (ii) An updated exclusions list after consideration of public 
comment.
    (5) For performance years 6 through 8, the list of excluded services 
posted on the CMS website as it appears at the beginning of performance 
year 5 will apply and will not be updated.

[80 FR 73540, Nov. 24, 2015, as amended at 85 FR 19292, Apr. 6, 2020; 85 
FR 71199, Nov. 6, 2020; 86 FR 23570, May 3, 2021]



Sec. 510.205  Beneficiary inclusion criteria.

    (a) Episodes tested in the CJR model include only those in which 
care is furnished to beneficiaries who meet all of the following 
criteria upon admission to the anchor hospitalization:
    (1) Are enrolled in Medicare Parts A and Part B.
    (2) Eligibility for Medicare is not on the basis of end stage renal 
disease, as described in Sec. 406.13 of this chapter.
    (3) Are not enrolled in any managed care plan (for example, Medicare 
Advantage, health care prepayment plans, or cost-based health 
maintenance organizations).
    (4) Are not covered under a United Mine Workers of America health 
care plan.
    (5) Have Medicare as their primary payer.
    (6) For episodes beginning on or after July 1, 2017, are not 
prospectively assigned to--
    (i) An ACO in the Next Generation ACO model;
    (ii) An ACO in a track of the Comprehensive ESRD Care Model 
incorporating downside risk for financial losses; or
    (iii) A Shared Savings Program ACO in the ENHANCED track (formerly 
Track 3).
    (b) If at any time during the episode a beneficiary no longer meets 
all of the criteria in this section, the episode is canceled in 
accordance with Sec. 510.210(b).

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 613, Jan. 3, 2017; 86 
FR 23571, May 3, 2021]



Sec. 510.210  Determination of the episode.

    (a) General. (1) An episode begins with the admission of a Medicare 
beneficiary described in Sec. 510.205 to a participant hospital for an 
anchor hospitalization and ends on the 90th day after the date of 
discharge, with the day of discharge itself being counted as the first 
day in the 90-day post-discharge period.
    (2) On or after July 4, 2021, an episode--
    (i) Begins and ends in the manner specified in paragraph (a)(1) of 
this section; or
    (ii) Begins on the date of service of an anchor procedure furnished 
to a Medicare beneficiary described in Sec. 510.205 and ends on the 
90th day after the date of service of the anchor procedure.
    (b) Cancellation of an episode. The episode is canceled and is not 
included in the determination of NPRA as specified in Sec. 510.305 if 
any of the following occur:
    (1) The beneficiary does any of the following during the episode:
    (i) Ceases to meet any criterion listed in Sec. 510.205.
    (ii) Is readmitted to any participant hospital for another anchor 
hospitalization, or, on or after July 4, 2021, receives an anchor 
procedure at any participant hospital.
    (iii) Initiates an LEJR episode under BPCI.
    (iv) Dies.
    (2) For performance year 3, the participant hospital did not submit 
a participation election letter that was accepted by CMS to continue 
participation in the model.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 57104, Dec. 1, 2017; 86 
FR 23571, May 3, 2021]



                      Subpart D_Pricing and Payment



Sec. 510.300  Determination of episode quality-adjusted target prices.

    (a) General. CMS establishes episode quality-adjusted target prices 
for participant hospitals for each performance

[[Page 911]]

year or performance year subset of the model as specified in this 
section. Episode quality-adjusted target prices are established 
according to the following:
    (1) MS-DRG and fracture status. MS-DRG assigned at discharge for 
anchor hospitalization and present of hip fracture diagnosis for anchor 
hospitalization--
    (i)(A) MS-DRG 469 with hip fracture; or
    (B) For episodes beginning on or after October 1, 2020, MS-DRG 521;
    (ii) MS-DRG 469 without hip fracture;
    (iii)(A) MS-DRG 470 with hip fracture; or
    (B) For episodes beginning on or after October 1, 2020, MS-DRG 522; 
or
    (iv) MS-DRG 470 without hip fracture.
    (2) Applicable time period for performance year or performance year 
subset episode quality-adjusted target prices. For performance years 1 
through 4 and performance year subset 5.1 only, episode quality-adjusted 
target prices are updated to account for Medicare payment updates no 
less than 2 times per year, for updated quality-adjusted target prices 
effective October 1 and January 1, and at other intervals if necessary.
    (3) Episodes that straddle performance years, performance year 
subsets, or payment updates. The quality-adjusted target price that 
applies to the episode is one of the following:
    (i) For episodes beginning on or after April 1, 2016 and ending on 
or before September 30, 2021, the date of admission for the anchor 
hospitalization.
    (ii) For episodes beginning on or after July 4, 2021 and ending on 
or after October 1, 2021, the date of the anchor procedure or the date 
of admission for the anchor hospitalization, as applicable.
    (4) Identifying episodes with hip fracture. CMS develops a list of 
ICD-CM hip fracture diagnosis codes that, when reported in the principal 
diagnosis code files on the claim for the anchor hospitalization or 
anchor procedure, represent a bone fracture for which a hip replacement 
procedure, either a partial hip arthroplasty or a total hip 
arthroplasty, could be the primary surgical treatment. The list of ICD-
CM hip fracture diagnosis codes used to identify hip fracture episodes 
can be found on the CMS website. Beginning on October 1, 2020, hip 
fracture episodes initiated by an anchor hospitalization will be 
identified by MS-DRGs 521 and 522.
    (i) For performance years 1 through 5 only, on an annual basis, or 
more frequently as needed, CMS updates the list of ICD-CM hip fracture 
diagnosis codes to reflect coding changes or other issues brought to 
CMS' attention.
    (ii) For performance years 1 through 5 only, CMS applies the 
following standards when revising the list of ICD-CM hip fracture 
diagnosis codes.
    (A) The ICD-CM diagnosis code is sufficiently specific that it 
represents a bone fracture for which a physician could determine that a 
hip replacement procedure, either a Partial Hip Arthroplasty (PHA) or a 
THA, could be the primary surgical treatment.
    (B) The ICD-CM diagnosis code is the primary reason (that is, 
principal diagnosis code) for the anchor hospitalization.
    (iii) For performance years 1 through 5 only, CMS posts the 
following to the CMS website:
    (A) Potential ICD-CM hip fracture diagnosis codes for public 
comment; and
    (B) A final ICD-CM hip fracture diagnosis code list after 
consideration of public comment.
    (iv) For performance years 6 through 8, the hip fracture diagnosis 
code list posted at https://innovation.cms.gov/Files/worksheets/cjr-
icd10hipfracturecodes.xlsx as it appears at the beginning of performance 
year 5 will not be updated. The hip fracture diagnosis code list will be 
used to identify hip fracture episodes initiated by an anchor procedure 
in performance years 6 through 8.
    (5) Quality performance. Quality-adjusted target prices reflect 
effective discount factors or applicable discount factors based on a 
hospital's composite quality score, as specified in Sec. Sec. 
510.300(c) and 510.315(f).
    (6) For episodes beginning on or after July 4, 2021 that are 
initiated by an anchor procedure, permitted OP TKAs and OP THAs are 
grouped with MS-DRG 470 or MS-DRG 522 episodes as follows:
    (i) Permitted OP THAs with hip fracture group with MS-DRG 522.

[[Page 912]]

    (ii) Permitted OP THAs without hip fracture and permitted OP TKAs 
group with MS-DRG 470.
    (b)  Episode quality-adjusted target price. (1) CMS calculates 
quality-adjusted target prices based on a blend of each participant 
hospital's hospital-specific and regional episode expenditures. The 
region corresponds to the U.S. Census Division associated with the 
primary address of the CCN of the participant hospital and the regional 
component is based on all hospitals in said region, except as follows. 
In cases where an MSA selected for participation in CJR spans more than 
one U.S. Census Division, the entire MSA will be grouped into the U.S. 
Census Division where the largest city by population in the MSA is 
located for quality-adjusted target price and reconciliation 
calculations. The calendar years used for historical expenditure 
calculations are as follows:
    (i) Episodes beginning in 2012 through 2014 for performance years 1 
and 2.
    (ii) Episodes beginning in 2014 through 2016 for performance years 3 
and 4.
    (iii) Episodes beginning in 2016 through 2018 for each of 
performance year subsets 5.1 and 5.2.
    (iv) Episodes beginning in 2019 for performance year 6.
    (v) Episodes beginning in 2021 for performance year 7.
    (vi) Episodes beginning in 2022 for performance year 8.
    (2) Specifically, the blend consists of the following:
    (i) Two-thirds of the participant hospital's own historical episode 
payments and one-third of the regional historical episode payments for 
performance years 1 and 2.
    (ii) One-third of the hospital's own historical episode payments and 
two-thirds of the regional historical episode payments for performance 
year 3.
    (iii) Regional historical episode payments for performance year 4, 
for each subset of performance year 5, and performance years 6 through 
8.
    (3) Exception for low-volume hospitals. Quality-adjusted target 
prices for participant hospitals with fewer than 20 CJR episodes in 
total across the 3 historical years of data used to calculate the 
quality-adjusted target price are based on 100 percent regional 
historical episode payments.
    (4) Exception for recently merged or split hospitals. Hospital-
specific historical episode payments for participant hospitals that have 
undergone a merger, consolidation, spin off or other reorganization that 
results in a new hospital entity without 3 full years of historical 
claims data are determined using the historical episode payments 
attributed to their predecessor(s).
    (5) Exception for high episode spending. (i) For performance years 1 
through 4, and for performance year 5, each subset thereof, episode 
payments are capped at 2 standard deviations above the mean regional 
episode payment for both the hospital-specific and regional components 
of the quality-adjusted target price.
    (ii) For performance years 6 through 8, episode payments are capped 
at the 99th percentile of regional spending for each of the four MS-DRG 
categories, as specified in Sec. 510.300(a)(1) and (6).
    (6) Exclusion of incentive programs and add-on payments under 
existing Medicare payment systems. Certain incentive programs and add-on 
payments are excluded from historical episode payments by using, with 
certain modifications, the CMS Price (Payment) Standardization Detailed 
Methodology used for the Medicare spending per beneficiary measure in 
the Hospital Value-Based Purchasing Program.
    (7) Communication of episode quality-adjusted target prices. CMS 
communicates episode quality-adjusted target prices to participant 
hospitals before the performance period in which they apply.
    (8) Inclusion of reconciliation payments and repayments. For 
performance years 3, 4, and each of performance year subsets 5.1 and 5.2 
only, reconciliation payments and repayment amounts under Sec. 
510.305(f)(2) and (3) and from LEJR episodes included in the BPCI 
initiative are included in historical episode payments.
    (c) Discount factor. A participant hospital's episode quality-
adjusted target prices incorporate discount factors to reflect 
Medicare's portion of reduced expenditures from the CJR model as 
described in this section.

[[Page 913]]

    (1) Discount factors affected by the quality incentive payments and 
the composite quality score. In all performance years and performance 
year subsets, the discount factor may be affected by the quality 
incentive payment and composite quality score as provided in Sec. 
510.315 to create the effective discount factor or applicable discount 
factor used for calculating reconciliation payments and repayment 
amounts. The quality-adjusted target prices incorporate the effective or 
applicable discount factor at reconciliation.
    (2) Discount factor for reconciliation payments. The discount factor 
for reconciliation payments in all performance years and performance 
year subsets is 3.0 percent.
    (3) Discount factors for repayment amounts. The discount factor for 
repayment amounts is--
    (i) Not applicable in performance year 1, as the requirement for 
hospital repayment under the CJR model is waived in performance year 1;
    (ii) In performance years 2 and 3, 2.0 percent; and
    (iii) In performance years 4, each subset of performance year 5, and 
performance years 6 through 8, 3.0 percent.
    (d) Data sharing. (1) CMS makes available to participant hospitals, 
through the most appropriate means, data that CMS determines may be 
useful to participant hospitals to do the following:
    (i) Determine appropriate ways to increase the coordination of care.
    (ii) Improve quality.
    (iii) Enhance efficiencies in the delivery of care.
    (iv) Otherwise achieve the goals of the CJR model described in this 
section.
    (2) Beneficiary-identifiable data. (i) CMS makes beneficiary-
identifiable data available to a participant hospital in accordance with 
applicable privacy laws and only in response to the hospital's request 
for such data for a beneficiary who has been furnished a billable 
service by the participant hospital corresponding to the episode 
definitions for CJR.
    (ii) The minimum data necessary to achieve the goals of the CJR 
model, as determined by CMS, may be provided under this section for a 
participant hospital's baseline period and no less frequently than on a 
quarterly basis throughout the hospital's participation in the CJR 
model.

[80 FR 73540, Nov. 24, 2015, as amended at 81 FR 11451, Mar. 4, 2016; 82 
FR 613, Jan. 3, 2017; 82 FR 57104, Dec. 1, 2017; 85 FR 71199, Nov. 6, 
2020; 86 FR 23571, May 3, 2021]



Sec. 510.301  Determination of reconciliation target prices.

    Beginning with performance year 6, the quality-adjusted target price 
computed under Sec. 510.300 is further adjusted for risk and market 
trends as described in this section to arrive at the reconciliation 
target price amount, with the exception of episodes that are reconciled 
in performance year 6 but subject to a performance year subset 5.2 
target price. Specifically:
    (a) Risk adjustment. (1) The quality-adjusted target prices computed 
under Sec. 510.300 are risk adjusted at a beneficiary level by a CJR 
HCC count risk adjustment factor, an age bracket risk adjustment factor, 
and a dual-eligibility status risk adjustment factor. All three factors 
are binary, yes/no variables, meaning that a beneficiary either does or 
does not meet the criteria for a specific variable.
    (i) The CJR HCC count risk adjustment factor uses five variables, 
representing beneficiaries with zero, one, two, three, or four or more 
CMS-HCC conditions.
    (ii) The age bracket risk adjustment factor uses four variables, 
representing beneficiaries aged--
    (A) Less than 65 years;
    (B) 65 to 74 years;
    (C) 75 years to 84 years; or
    (D) 85 years or more.
    (iii) The dual-eligibility status factor uses two variables, 
representing beneficiaries that are eligible for full Medicaid benefits 
or beneficiaries that are not eligible for full Medicaid benefits.
    (2) All three factors are computed prior to the start of performance 
years 6 and 8 via a linear regression analysis. The regression analysis 
is computed using 1 year of claims data as follows:
    (i) For performance year 6, CMS uses claims data with dates of 
service dated January 1, 2019 to December 31, 2019.
    (ii) For performance year 7, CMS uses the same regression analysis 
results

[[Page 914]]

and corresponding coefficients that were calculated for performance year 
6.
    (iii) For performance year 8, CMS uses claims data with dates of 
service dated January 1, 2021 to December 31, 2021.
    (3)(i) The dependent variable in the annual regression that produces 
the risk adjustment coefficients is equal to the difference between the 
log transformed target price calculated under Sec. 510.300 and the 
capped episode costs as described in Sec. 510.300(b)(5)(ii).
    (ii) The independent variables are binary values assigned to each 
CJR HCC count variable, age bracket variable and dual-eligibility status 
variable.
    (iii) Using these variables, the annual regression produces 
exponentiated coefficients to determine the anticipated marginal effect 
of each risk adjustment factor on episode costs. CMS transforms, or 
exponentiate, these coefficients in order to ``reverse'' the previous 
logarithmic transformation, and the resulting coefficients are the CJR 
HCC count risk adjustment factor, the age bracket risk adjustment 
factor, and the dual-eligibility status factor that would be used during 
reconciliation for the subsequent performance year.
    (4)(i) At the time of reconciliation, the quality adjusted target 
prices computed under Sec. 510.300 are risk adjusted at the beneficiary 
level by applying the applicable CJR HCC count risk adjustment factor, 
the age bracket risk adjustment factor, and the dual-eligibility risk 
adjustment factor specific to the beneficiary in the episode.
    (ii)(A) For the CJR HCC count risk adjustment factor, applicable 
means the coefficient that applies to the CMS-HCC condition count for 
the beneficiary in the episode;
    (B) For the age bracket risk adjustment factor, applicable means the 
coefficient for the age bracket into which the beneficiary falls on the 
first day of the episode; and
    (C) For the dual-eligibility risk adjustment factor, applicable 
means the coefficient for beneficiaries that are eligible for full 
Medicaid benefits on the first day of the episode.
    (5)(i) The risk-adjusted target prices are normalized at 
reconciliation to remove the overall impact of adjusting for age, CJR 
HCC count, and dual-eligibility status on the national average target 
price.
    (ii) The normalization factor is the national mean of the target 
price for all episode types divided by the national mean of the risk-
adjusted target price.
    (iii) CMS applies the normalization factor to the previously 
calculated, beneficiary-level, risk-adjusted target prices specific to 
each episode region and MS-DRG combination (as specified in paragraph 
(a)(4) of this section).
    (iv) These normalized target prices are then further adjusted for 
market trends (as specified in paragraph (b) of this section) and 
quality performance (as specified at Sec. 510.300) to become the 
reconciliation target prices, which are compared to actual episode costs 
at reconciliation, as specified in Sec. 510.305(m)(1)(i).
    (b) Market trend adjustment factor. (1) The risk-adjusted quality-
adjusted target price computed under Sec. 510.300 and paragraph (a) of 
this section is further adjusted for market trend changes at the region 
and MS-DRG level.
    (2) This adjustment is accomplished by multiplying each risk-
adjusted quality-adjusted target price computed under Sec. 510.300 and 
paragraph (a) of this section by the applicable market trend adjustment 
factor.
    (3) The applicable market trend adjustment factor is calculated as 
the percent difference between the average regional MS-DRG episode costs 
computed using the performance year claims data and comparison average 
regional MS-DRG fracture episode costs computed using historical 
calendar year claims data used to calculate the regional target prices 
in effect for that performance year.

[86 FR 23571, May 3, 2021]



Sec. 510.305  Determination of the NPRA and reconciliation process.

    (a) General. Providers and suppliers furnishing items and services 
included in the episode bill for such items and services in accordance 
with existing rules and as if this part were not in effect.
    (b) Reconciliation. (1) For performance years 1 through 4 and for 
each subset of performance year 5, CMS uses a series

[[Page 915]]

of reconciliation processes, which CMS performs as described in 
paragraphs (d) and (f) of this section after the end of each performance 
year, to establish final payment amounts to participant hospitals for 
CJR model episodes for a given performance year.
    (2) For performance years 6 through 8, CMS conducts one 
reconciliation process, which CMS performs as described in paragraphs 
(l) and (m) of this section after the end of each performance year, to 
establish final payment amounts to participant hospitals for CJR model 
episodes for a given performance year.
    (3) Following the end of each performance year, for performance 
years 1 through 4 and for performance year 5, each subset thereof, CMS 
determines actual episode payments for each episode for the performance 
year (other than episodes that have been canceled in accordance with 
Sec. 510.210(b)) and determines the amount of a reconciliation payment 
or repayment amount.
    (c) Data used. CMS uses the most recent claims data available to 
perform each reconciliation calculation.
    (d) Annual reconciliation for performance years 1 through 5. (1) 
Beginning 2 months after the end of each of performance years 1 through 
4 and performance year subset 5.1 and 5 months after the end of 
performance year subset 5.2, CMS does all of the following:
    (i) Performs a reconciliation calculation to establish an NPRA for 
each participant hospital.
    (ii) For participant hospitals that experience a reorganization 
event in which one or more hospitals reorganize under the CCN of a 
participant hospital performs--
    (A) Separate reconciliation calculations (during both initial and 
subsequent reconciliations for a performance year) for each predecessor 
participant hospital for episodes where anchor hospitalization admission 
occurred before the effective date of the reorganization event; and
    (B) Reconciliation calculations (during both initial and subsequent 
reconciliations for a performance year) for each new or surviving 
participant hospital for episodes where the anchor hospitalization 
admission occurred on or after the effective date of the reorganization 
event.
    (2) CMS--
    (i) Calculates the NPRA for each participant hospital in accordance 
with paragraph (e) of this section including the adjustments provided 
for in paragraph (e)(1)(iv) of this section; and
    (ii) Assesses whether hospitals meet specified quality requirements 
under Sec. 510.315.
    (e) Calculation of the NPRA for performance years 1 through 5. By 
comparing the quality-adjusted target prices described in Sec. 510.300 
and the participant hospital's actual episode spending for each of 
performance years 1 through 4, and for performance year 5, each subset 
thereof, and applying the adjustments in paragraph (e)(1)(v) of this 
section, CMS establishes an NPRA for each participant hospital for each 
of performance years 1 through 4 and for performance year 5, each subset 
thereof.
    (1) Initial calculation. In calculating the NPRA for each 
participant hospital for each of performance years 1 through 4 and each 
of performance year subsets 5.1 and 5.2, CMS does the following:
    (i) Determines actual episode payments for each episode included in 
the performance year or performance year subset (other than episodes 
that have been canceled in accordance with Sec. 510.210(b)) using 
claims data that is available 2 months after the end of the performance 
year or performance year subset. Actual episode payments are capped, as 
applicable, at the amount determined in accordance with Sec. 
510.300(b)(5) for the performance year or performance year subset at the 
amount determined in paragraph (k) of this section for episodes affected 
by extreme and uncontrollable circumstances, or at the quality adjusted 
target price determined for that episode under Sec. 510.300 for an 
episode with actual episode payments that include a claim with a COVID-
19 diagnosis code and initiate after the earlier of March 31, 2021 or 
the last day of the emergency period described in paragraph (k)(4) of 
this section.
    (ii) Multiplies each episode quality-adjusted target price by the 
number of episodes included in the performance

[[Page 916]]

year or performance year subset (other than episodes that have been 
canceled in accordance with Sec. 510.210(b)) to which that episode 
quality-adjusted target price applies.
    (iii) Aggregates the amounts computed in paragraph (e)(1)(ii) of 
this section for all episodes included in the performance year or 
performance year subset (other than episodes that have been canceled in 
accordance with Sec. 510.210(b)).
    (iv) Subtracts the amount determined under paragraph (e)(1)(i) of 
this section from the amount determined under paragraph (e)(1)(iii) of 
this section.
    (v) Applies the following prior to determination of the 
reconciliation payment or repayment amount:
    (A) Limitation on loss. Except as provided in paragraph (e)(1)(v)(C) 
of this section, the total amount of the NPRA and subsequent 
reconciliation calculation for a performance year or performance year 
subset cannot exceed the following:
    (1) For performance year 2 only, 5 percent of the amount calculated 
in paragraph (e)(1)(iii) of this section for the performance year.
    (2) For performance year 3, 10 percent of the amount calculated in 
paragraph (e)(1)(iii) of this section for the performance year.
    (3) For performance year 4 and each of performance year subsets 5.1 
and 5.2, 20 percent of the amount calculated in paragraph (e)(1)(iii) of 
this section for the performance year or performance year subset.
    (4) As provided in paragraph (i) of this section, the subsequent 
reconciliation calculation reassesses the limitation on loss for a given 
performance year by applying the limitations on loss to the aggregate of 
the 2 reconciliation calculations.
    (5) The post-episode spending and ACO overlap calculation amounts in 
paragraphs (j)(1) and (2) of this section are not subject to the 
limitation on loss.
    (B) Limitation on gain. The total amount of the NPRA and subsequent 
reconciliation calculation for a performance year or performance year 
subset cannot exceed the following:
    (1) For performance years 1 and 2, 5 percent of the amount 
calculated in paragraph (e)(1)(iii) of this section for the performance 
year.
    (2) For performance year 3, 10 percent of the amount calculated in 
paragraph (e)(1)(iii) of this section for the performance year.
    (3) For performance year 4 and each of performance year subsets 5.1 
and 5.2, 20 percent of the amount calculated in paragraph (e)(1)(iii) of 
this section for the performance year or performance year subset.
    (4) As provided in paragraph (i) of this section, the subsequent 
reconciliation calculation reassesses the limitation on gain for a given 
performance year by applying the limitations on gain to the aggregate of 
the 2 reconciliation calculations.
    (5) The post-episode spending and ACO overlap calculation amounts in 
paragraphs (j)(1) and (j)(2) of this section are not subject to the 
limitation on gain.
    (C) Financial loss limits for rural hospitals, SCHs, MDHs, and RRCs. 
If a participant hospital is a rural hospital, SCH, MDH, or RRC, then 
for performance year 2, the total repayment amount for which the 
participant hospital is responsible due to the NPRA and subsequent 
reconciliation calculation cannot exceed 3 percent of the amount 
calculated in paragraph (e)(1)(iii) of this section. For performance 
years 3 and 4 and for performance year subsets 5.1 and 5.2, the amount 
cannot exceed 5 percent of the amount calculated in paragraph 
(e)(1)(iii) of this section.
    (f) Determination of reconciliation or repayment amount--(1) 
Determination of the reconciliation or repayment amount. (i) Subject to 
paragraph (f)(1)(iii) of this section, for performance year 1, the 
reconciliation payment (if any) is equal to the NPRA.
    (ii) Subject to paragraph (f)(1)(iii) of this section, for 
performance years 2 through 4 and for each of performance year subsets 
5.1 and 5.2, results from the subsequent reconciliation calculation for 
a prior year's reconciliation as described in paragraph (i) of this 
section and the post-episode spending and ACO overlap calculations as 
described in paragraph (j) of this section are

[[Page 917]]

added to the current year's NPRA in order to determine the 
reconciliation payment or repayment amount.
    (iii) The reconciliation or repayment amount may be adjusted as 
provided in Sec. 510.410(b).
    (iv) Results from the performance year 6 reconciliation and post-
episode spending calculations as described in paragraph (m) of this 
section are added together in order to determine the reconciliation 
payment or repayment amount for performance year 6.
    (v) Results from the performance year 7 reconciliation and post-
episode spending calculations as described in paragraph (m) of this 
section are added together in order to determine the reconciliation 
payment or repayment amount for performance year 7.
    (vi) Results from the performance year 8 reconciliation and post-
episode spending calculations as described in paragraph (m) of this 
section are added together in order to determine the reconciliation 
payment or repayment amount for performance year 8.
    (2) Reconciliation payment. If the amount described in paragraph 
(f)(1) of this section is positive and the composite quality score 
described in Sec. 510.315 is acceptable (defined as greater than or 
equal to 5.00 and less than 6.9), good (defined as greater than or equal 
to 6.9 and less than or equal to 15.0), or excellent (defined as greater 
than 15.0), Medicare pays the participant hospital a reconciliation 
payment in an amount equal to the amount described in paragraph (f)(1) 
of this section.
    (3) Repayment amount. If the amount described in paragraph (f)(1) of 
this section is negative, the participant hospital pays to Medicare an 
amount equal to the amount described in paragraph (f)(1) of this 
section, in accordance with Sec. 405.371 of this chapter. CMS waives 
this requirement for performance year 1.
    (g) Determination of eligibility for reconciliation based on 
quality. (1) CMS assesses each participant hospital's performance on 
quality metrics, as described in Sec. 510.315, to determine whether the 
participant hospital is eligible to receive a reconciliation payment for 
a performance year or performance year subset.
    (2) If the hospital's composite quality score described in Sec. 
510.315 is acceptable (defined as greater than or equal to 5.00 and less 
than 6.9), good (defined as greater than or equal to 6.9 and less than 
or equal to 15.0), or excellent (defined as greater than 15.0), and the 
hospital is determined to have a positive NPRA under Sec. 510.305(e)), 
the hospital is eligible for a reconciliation payment.
    (3) If the hospital's composite quality score described in Sec. 
510.315 is below acceptable, defined as less than 4.00 for a performance 
year or performance year subset, the hospital is not eligible for a 
reconciliation payment.
    (4) If the hospital is found to be engaged in an inappropriate and 
systemic under delivery of care, the quality of the care provided must 
be considered to be seriously compromised and the hospital must be 
ineligible to receive or retain a reconciliation payment for any period 
in which such under delivery of care was found to occur.
    (h) Reconciliation report. CMS issues each participant hospital a 
CJR reconciliation report for the performance year or performance year 
subset. Each CJR reconciliation report contains the following:
    (1) Information on the participant hospital's composite quality 
score described in Sec. 510.315.
    (2) The total actual episode payments for the participant hospital.
    (3) The NPRA.
    (4) Whether the participant hospital is eligible for a 
reconciliation payment or must make a repayment to Medicare.
    (5) As applicable, the NPRA and subsequent reconciliation 
calculation amount for the previous performance year or performance year 
subset.
    (6) As applicable, the post-episode spending amount and ACO overlap 
calculation for the previous performance year or performance year 
subset.
    (7) The reconciliation payment or repayment amount.
    (i) Subsequent reconciliation calculation. (1) Fourteen months after 
the end of each of performance years 1 through 4 and performance year 
subset 5.1 and seventeen months after the end of performance year subset 
5.2, CMS performs an additional calculation, using claims data available 
at that time, to

[[Page 918]]

account for final claims run-out and any additional episode cancelations 
due to overlap between the CJR model and other CMS models and programs, 
or for other reasons as specified in Sec. 510.210(b).
    (2) The subsequent calculation for each of performance years 1 
through 4 and performance year subset 5.1 occurs concurrently with the 
first reconciliation process for the following performance year (or in 
the case of performance year subset 5.1, with the first reconciliation 
of performance year subset 5.2). If the result of the subsequent 
calculation is different than zero, CMS applies the stop-loss and stop-
gain limits in paragraph (e) of this section to the aggregate 
calculation of the amounts described in paragraphs (e)(1)(iv) and (i)(1) 
of this section for that performance year or performance year subset 
(the initial reconciliation and the subsequent reconciliation 
calculation) to ensure such amount does not exceed the applicable stop-
loss or stop-gain limits. The subsequent reconciliation calculation for 
performance year subset 5.2 will occur independently in 2023.
    (j) Additional adjustments to the reconciliation payment or 
repayment amount. (1) In order to account for shared savings payments, 
CMS will reduce the reconciliation payment or increase the repayment 
amount for the subsequent performance year (for performance years 1 
through 4 and performance year subset 5.1) by the amount of the 
participant hospital's discount percentage that is paid to the ACO in 
the prior performance year as shared savings. (This amount will be 
assessed independently for performance year subset 5.2 in 2023.) This 
adjustment is made only when the participant hospital is a participant 
or provider/supplier in the ACO and the beneficiary in the CJR episode 
is assigned to one of the following ACO models or programs:
    (i) The Pioneer ACO model.
    (ii) The Medicare Shared Savings Program (excluding Track 3 for CJR 
episodes that initiate on or after July 1, 2017).
    (iii) The Comprehensive ESRD Care Initiative (excluding a track with 
downside risk for CJR episodes that initiate after July 1, 2017).
    (iv) The Next Generation ACO model (excluding CJR episodes that 
initiate on or after July 1, 2017).
    (2) If the average post-episode Medicare Parts A and B payments for 
a participant hospital in the prior performance year or performance year 
subset is greater than 3 standard deviations above the regional average 
post-episode payments for the same performance year or performance year 
subset, then the spending amount exceeding 3 standard deviations above 
the regional average post-episode payments for the same performance year 
or performance year subset is subtracted from the net reconciliation or 
added to the repayment amount for the subsequent performance year for 
years 1 through 4 and performance year subset 5.1, and assessed 
independently for performance year subset 5.2.
    (k) Extreme and uncontrollable circumstances adjustment. (1) The 
episode spending adjustments specified in paragraph (k)(2) of this 
section apply for a participant hospital that has a CCN primary address 
that meets both of the following:
    (i) Is located in an emergency area during an emergency period, as 
those terms are defined in section 1135(g) of the Act, for which the 
Secretary has issued a waiver under section 1135; and
    (ii) Is located in a county, parish, or tribal government designated 
in a major disaster declaration under the Stafford Act.
    (2)(i) For a non-fracture episode with a date of admission to the 
anchor hospitalization that is on or within 30 days before the date that 
the emergency period (as defined in section 1135(g) of the Act) begins, 
actual episode payments are capped at the target price determined for 
that episode under Sec. 510.300.
    (ii) For a fracture episode with a date of admission to the anchor 
hospitalization that is on or within 30 days before or after the date 
that the emergency period (as defined in section 1135(g) of the Act) 
begins, actual episode payments are capped at the target price 
determined for that episode under Sec. 510.300.

[[Page 919]]

    (3) The following is an extreme and uncontrollable circumstances 
adjustment for 2019 Novel Coronavirus (previously referred to as 2019-
nCoV, now as COVID-19):
    (i) The episode spending adjustments specified in paragraph (k)(4) 
of this section apply for a participant hospital that has a CCN primary 
address that is located in an emergency area during an emergency period, 
as those terms are defined in section 1135(g) of the Act, for which the 
Secretary issued a waiver or modification of requirements under section 
1135 of the Act on March 13, 2020.
    (ii) [Reserved]
    (4) For a fracture or non-fracture episode with a date of admission 
to the anchor hospitalization that is on or within 30 days before the 
date that the emergency period (as defined in section 1135(g) of the 
Act) begins or that occurs on or before March 31, 2021 or the last day 
of such emergency period, whichever is earlier, actual episode payments 
are capped at the quality adjusted target price determined for that 
episode under Sec. 510.300.
    (l) Annual reconciliation for performance years 6 through 8. (1) 
Beginning 6 months after the end of each of performance years 6 through 
8, CMS does all of the following:
    (i) Performs a reconciliation calculation to establish an NPRA for 
each participant hospital.
    (ii) For participant hospitals that experience a reorganization 
event in which one or more hospitals reorganize under the CCN of a 
participant hospital, performs--
    (A) Separate reconciliation calculations for each predecessor 
participant hospital for episodes where the anchor hospitalization 
admission or the anchor procedure occurred before the effective date of 
the reorganization event; and
    (B) Reconciliation calculations for each new or surviving 
participant hospital for episodes where the anchor hospitalization 
admission or anchor procedure occurred on or after the effective date of 
the reorganization event.
    (2) CMS--
    (i) Calculates the NPRA for each participant hospital in accordance 
with paragraph (m) of this section including the adjustments provided 
for in paragraph (m)(1)(vii) of this section; and
    (ii) Assesses whether participant hospitals meet specified quality 
requirements under Sec. 510.315.
    (m) Calculation of the NPRA for performance years 6 through 8. By 
comparing the reconciliation target prices described in Sec. 510.301 
and the participant hospital's actual episode spending for the 
performance year and applying the adjustments in paragraph (m)(1)(vii) 
of this section, CMS establishes an NPRA for each participant hospital 
for each of performance years 6 through 8.
    (1) In calculating the NPRA for each participant hospital for each 
performance year, CMS does the following:
    (i) Determines actual episode payments for each episode included in 
the performance year (other than episodes that have been canceled in 
accordance with Sec. 510.210(b)) using claims data that is available 6 
months after the end of the performance year. Actual episode payments 
are capped at the amount determined in accordance with Sec. 
510.300(b)(5)(ii) for the performance year, the amount determined in 
paragraph (k) of this section for episodes affected by extreme and 
uncontrollable circumstances, or the target price determined for that 
episode under Sec. 510.300 for episodes that contain a COVID-19 
Diagnosis Code as defined in Sec. 510.2.
    (ii) Multiplies each episode reconciliation target price by the 
number of episodes included in the performance year (other than episodes 
that have been canceled in accordance with Sec. 510.210(b)) to which 
that episode reconciliation target price applies.
    (iii) Aggregates the amounts computed in paragraph (m)(1)(ii) of 
this section for all episodes included in the performance year (other 
than episodes that have been canceled in accordance with Sec. 
510.210(b)).
    (iv) Subtracts the amount determined under paragraph (m)(1)(i) of 
this section from the amount determined under paragraph (m)(1)(iii) of 
this section.
    (v) Performs an additional calculation using claims data available 
at that time, to account for any episode

[[Page 920]]

cancelations due to overlap between the CJR model and other CMS models 
and programs, or for other reasons as specified in Sec. 510.210(b).
    (vi) Conducts a post-episode spending calculation as follows: If the 
average post-episode Medicare Parts A and B payments for a participant 
hospital in the performance year being reconciled is greater than 3 
standard deviations above the regional average post-episode payments for 
that same performance year, then the spending amount exceeding 3 
standard deviations above the regional average post-episode payments for 
the same performance year is subtracted from the net reconciliation or 
added to the repayment for that performance year.
    (vii) Applies the following prior to determination of the 
reconciliation payment or repayment amount:
    (A) Limitation on loss. Except as provided in paragraph 
(m)(1)(vii)(C) of this section, the total amount of the NPRA for a 
performance year cannot exceed 20 percent of the amount calculated in 
paragraph (m)(1)(iii) of this section for the performance year. The 
post-episode spending calculation amount in paragraph (m)(vi) of this 
section is not subject to the limitation on loss.
    (B) Limitation on gain. The total amount of the NPRA for a 
performance year cannot exceed 20 percent of the amount calculated in 
paragraph (m)(1)(iii) of this section for the performance year. The 
post-episode spending calculation amount in paragraph (m)(vi) of this 
section are not subject to the limitation on gain.
    (C) Limitation on loss for certain providers. Financial loss limits 
for rural hospitals, SCHs, MDHs, and RRCs for performance years 6 
through 8. If a participant hospital is a rural hospital, SCH, MDH, or 
RRC, the amount cannot exceed 5 percent of the amount calculated in 
paragraph (m)(1)(iii) of this section.
    (2) [Reserved]

[80 FR 73540, Nov. 24, 2015, as amended at 81 FR 11451, Mar. 4, 2016; 82 
FR 613, Jan. 3, 2017; 82 FR 57104, Dec. 1, 2017; 85 FR 19292, Apr. 6, 
2020; 85 FR 71199, Nov. 6, 2020; 86 FR 23572, May 3, 2021]

    Editorial Note: At 86 FR 23572, May 3, 2021, Sec. 510.305 was 
amended in part by revising paragraph (i); however, the amendment could 
not be incorporated due to inaccurate amendatory instruction.



Sec. 510.310  Appeals process.

    (a) Notice of calculation error (first level of appeal). Subject to 
the limitations on review in subpart D of this part, if a participant 
hospital wishes to dispute calculations involving a matter related to 
payment, reconciliation amounts, repayment amounts, the use of quality 
measure results in determining the composite quality score, or the 
application of the composite quality score during reconciliation, the 
participant hospital is required to provide written notice of the 
calculation error, in a form and manner specified by CMS.
    (1) Unless the participant hospital provides such notice, CMS deems 
final the CJR reconciliation report 45 calendar days after it is issued 
and proceeds with the payment or repayment processes as applicable.
    (2) If CMS receives a notice of a calculation error within 45 
calendar days of the issuance of the reconciliation report, CMS responds 
in writing within 30 calendar days to either confirm that there was an 
error in the calculation or verify that the calculation is correct, 
although CMS reserves the right to an extension upon written notice to 
the participant hospital.
    (3) Only participant hospitals may use the dispute resolution 
process described in this part.
    (4) Only participant hospitals may use the notice of calculation 
error process described in this part.
    (b) Dispute resolution process (second level of appeal). (1) If the 
participant hospital is dissatisfied with CMS's response to the notice 
of a calculation error, the participant hospital may request a 
reconsideration review in a form and manner as specified by CMS.
    (2) The reconsideration review request must provide a detailed 
explanation of the basis for the dispute and include supporting 
documentation for the participant hospital's assertion that CMS or its 
representatives did not accurately calculate the NPRA, the 
reconciliation payment, or the repayment amount in accordance with Sec. 
510.305.

[[Page 921]]

    (3) If CMS does not receive a request for reconsideration from the 
participant hospital within 10 calendar days of the issue date of CMS's 
response to the participant hospital's notice of calculation error, then 
CMS's response to the calculation error is deemed final and CMS proceeds 
with reconciliation payment or repayment processes, as applicable, as 
described in Sec. 510.305.
    (4) A CMS reconsideration official notifies the participant hospital 
in writing within 15 calendar days of receiving the participant 
hospital's review request of the following:
    (i) The issues in dispute.
    (ii) The review procedures.
    (iii) The procedures (including format and deadlines) for submission 
of briefs and evidence.
    (5) The provisions at Sec. 425.804(b), (c), and (e) of this chapter 
are applicable to reviews conducted in accordance with the 
reconsideration review process for CJR.
    (6) The CMS reconsideration official makes all reasonable efforts to 
issue a written determination within 30 days of the deadline for 
submission of briefs and evidence. The determination is final and 
binding.
    (c) Exception to the process. If the participant hospital contests a 
matter that does not involve an issue contained in, or a calculation 
that contributes to, a CJR reconciliation report, a notice of 
calculation error is not required. In these instances, if CMS does not 
receive a request for reconsideration from the participant hospital 
within 10 calendar days of the notice of the initial determination, the 
initial determination is deemed final and CMS proceeds with action 
indicated in the initial determination. This does not apply to the 
limitations on review in paragraph (e) of this section.
    (d) Notice of a participant hospital's termination from the CJR 
model. If a participant hospital receives notification that it has been 
terminated from the CJR model, it must provide a written notice to CMS 
requesting review of the termination within 10 calendar days of the 
notice. CMS has 30 days to respond to the participant hospital's request 
for review. If the participant hospital fails to notify CMS, the 
termination is deemed final.
    (e) Limitations on review. In accordance with section 1115A(d)(2) of 
the Act, there is no administrative or judicial review under sections 
1869 or 1878 of the Act or otherwise for the following:
    (1) The selection of models for testing or expansion under section 
1115A of the Act.
    (2) The selection of organizations, sites, or participants to test 
those models selected.
    (3) The elements, parameters, scope, and duration of such models for 
testing or dissemination.
    (4) Determinations regarding budget neutrality under section 
1115A(b)(3) of Act.
    (5) The termination or modification of the design and implementation 
of a model under section 1115A(b)(3)(B) of Act.
    (6) Decisions about expansion of the duration and scope of a model 
under section 1115A(c) of the Act, including the determination that a 
model is not expected to meet criteria described in section 1115A(c)(1) 
or (2) of the Act.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 615, Jan. 3, 2017; 86 
FR 23573, May 3, 2021]



Sec. 510.315  Composite quality scores for determining reconciliation
payment eligibility and quality incentive payments.

    (a) General. A participant hospital's eligibility for a 
reconciliation payment under Sec. 510.305(g), and the determination of 
quality incentive payments under paragraph (f) of this section, for a 
performance year or performance year subset depend on the hospital's 
composite quality score (including any quality performance points and 
quality improvement points earned) for that performance year or 
performance year subset.
    (b) Composite quality score. CMS calculates a composite quality 
score for each participant hospital for each performance year or 
performance year subset which equals the sum of the following:
    (1) The hospital's quality performance points for the hospital-level 
risk-standardized complication rate following elective primary total hip 
arthroplasty and/or total knee

[[Page 922]]

arthroplasty measure (NQF 1550) described in Sec. 510.400(a)(1). This 
measure is weighted at 50 percent of the composite quality score.
    (2) The hospital's quality performance points for the Hospital 
Consumer Assessment of Healthcare Providers and Systems Survey measure 
(NQF 0166) described in Sec. 510.400(a)(2). This measure is weighted 
at 40 percent of the composite quality score.
    (3) Any additional quality improvement points the hospital may earn 
as a result of demonstrating improvement on either or both of the 
quality measures in paragraphs (b)(1) and (2) of this section, as 
described in paragraph (d) of this section.
    (4) If applicable, 2 additional points for successful THA/TKA 
voluntary data submission of patient-reported outcomes and limited risk 
variable data, as described in Sec. 510.400(b). Successful submission 
is weighted at 10 percent of the composite quality score.
    (c) Quality performance points. CMS computes quality performance 
points for each quality measure based on the participant hospital's 
performance relative to the distribution of performance of all 
subsection (d) hospitals that are eligible for payment under IPPS and 
meet the minimum patient case or survey count for that measure.
    (1) For the hospital-level risk-standardized complication rate 
following elective primary total hip arthroplasty and/or total knee 
arthroplasty measure (NQF 1550) described in Sec. 510.400(a)(1), CMS 
assigns the participant hospital measure value to a performance 
percentile and then quality performance points are assigned based on the 
following performance percentile scale:
    (i) 10.00 points for =90th.
    (ii) 9.25 points for =80th and <90th.
    (iii) 8.50 points for =70th and <80th;
    (iv) 7.75 points for =60th and <70th.
    (v) 7.00 points for =50th and <60th.
    (vi) 6.25 points for =40th and <50th.
    (vii) 5.50 points for =30th and <40th.
    (viii) 0.0 points for <30th.
    (2) For the Hospital Consumer Assessment of Healthcare Providers and 
Systems Survey measure (NQF 0166) described in Sec. 510.400(a)(2), CMS 
assigns the participant hospital measure value to a performance 
percentile and quality performance points are assigned based on the 
following performance percentile scale:
    (i) 8.00 points for =90th.
    (ii) 7.40 points for =80th and <90th.
    (iii) 6.80 points for =70th and <80th.
    (iv) 6.20 points for =60th and <70th.
    (v) 5.60 points for =50th and <60th.
    (vi) 5.00 points for =40th and <50th.
    (vii) 4.40 points for =30th and <40th.
    (viii) 0.0 points for <30th.
    (d) Quality improvement points. (1) For performance year 1, if a 
participant hospital's quality performance percentile on an individual 
measure described in Sec. 510.400(a) increases from the corresponding 
time period in the previous year by at least 2 deciles on the 
performance percentile scale, then the hospitals is eligible to receive 
quality improvement points equal to 10 percent of the total available 
point for that individual measure up to a maximum composite quality 
score of 20 points.
    (2) For each of performance years 2 through 4, each of performance 
year subsets 5.1 and 5.2, and each of performance years 6 through 8, if 
a participant hospital's quality performance percentile on an individual 
measure described in Sec. 510.400(a) increases from the previous 
performance year or performance year subset by at least 2 deciles on the 
performance percentile scale, then the hospital is eligible to receive 
quality improvement points equal to 10 percent of the total available 
point for that individual measure up to a maximum composite quality 
score of 20 points.
    (e) Exception for hospitals without a measure value. In the case of 
a participant hospital without a measure value that would allow CMS to 
assign quality performance points for that quality measure, CMS assigns 
the 50th percentile quality performance points to the hospital for the 
individual measure.
    (1) A participant hospital will not have a measure value for the--
    (i) Hospital-level risk-standardized complication rate following 
elective primary total hip arthroplasty and/or total knee arthroplasty 
measure (NQF 1550) described in Sec. 510.400(a)(1) if the hospital 
does not meet the minimum 25 case count; or

[[Page 923]]

    (ii) Hospital Consumer Assessment of Healthcare Providers and 
Systems Survey measure (NQF 0166) described in Sec. 510.400(a)(2) if 
the hospital does not meet the minimum of 100 completed survey and does 
not have 4 consecutive quarters of HCAHPS data.
    (ii) For either of the measures described in paragraphs (e)(1) or 
(2) of this section, if CMS identifies an error in the data used to 
calculate the measure and suppresses the measure value.
    (f) Quality incentive payments. CMS provides incentive payments to 
participant hospitals that demonstrate good or excellent quality 
performance on the composite quality scores described in paragraph (b) 
of this section. These incentive payments are implemented in the form of 
the following reductions to the effective discount factors or applicable 
discount factors described in Sec. 510.300(c):
    (1) Performance years 1 through 5. For performance years 1 through 
5--
    (i) A 1.0 percentage point reduction to the effective discount 
factor or applicable discount factor for participant hospitals with good 
quality performance, defined as composite quality scores that are 
greater than or equal to 6.9 and less than or equal to 15.0; or
    (ii) A 1.5 percentage point reduction to the effective discount 
factor or applicable discount factor for participant hospitals with 
excellent quality performance, defined as composite quality scores that 
are greater than 15.0.
    (2) Performance years 6 through 8. For performance years 6 through 
8--
    (i) A 1.5-percentage point reduction to the effective discount 
factor or applicable discount factor for participant hospitals with good 
quality performance, defined as composite quality scores that are 
greater than or equal to 6.9 and less than or equal to 15.0; or
    (ii) A 3-percentage point reduction to the effective discount factor 
or applicable discount factor for participant hospitals with excellent 
quality performance, defined as composite quality scores that are 
greater than 15.0.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 615, Jan. 3, 2017; 85 
FR 71201, Nov. 6, 2020; 86 FR 23573, May 3, 2021]



Sec. 510.320  Treatment of incentive programs or add-on payments 
under existing Medicare payment systems.

    The CJR model does not replace any existing Medicare incentive 
programs or add-on payments. The target price and NPRA for a participant 
hospital are independent of, and do not affect, any incentive programs 
or add-on payments under existing Medicare payment systems.



Sec. 510.325  Allocation of payments for services that straddle the
episode.

    (a) General. Services included in the episode that straddle the 
episode are prorated so that only the portion attributable to care 
furnished during the episode are included in the calculation of actual 
episode payments.
    (b) Proration of services. Payments for services that straddle the 
episode are prorated using the following methodology:
    (1) Non-IPPS inpatient services and other inpatient services. Non-
IPPS inpatient services, and services furnished by other inpatient 
providers that extend beyond the end of the episode are prorated 
according to the percentage of the actual length of stay (in days) that 
falls within the episode.
    (2) Home health agency services. Home health services paid under the 
prospective payment system in part 484, subpart E of this chapter are 
prorated according to the percentage of days, starting with the first 
billable service date (``start of care date'') and through and including 
the last billable service date, that occur during the episode. This 
methodology is applied in the same way if the home health services begin 
(the start of care date) prior to the start of the episode.
    (3) IPPS services. IPPS claim amounts that extend beyond the end of 
the episode are prorated according to the geometric mean length of stay, 
using the following methodology:
    (i) The first day of the IPPS stay is counted as 2 days.
    (ii) If the actual length of stay that occurred during the episode 
is equal to or greater than the MS-DRG geometric mean, the normal MS-DRG 
payment is fully allocated to the episode.
    (iii) If the actual length of stay that occurred during the episode 
is less than

[[Page 924]]

the geometric mean, the normal MS-DRG payment amount is allocated to the 
episode based on the number of inpatient days that fall within the 
episode.
    (iv) If the full amount is not allocated to the episode, any 
remainder amount is allocated to the post-episode spending calculation 
(defined in Sec. 510.2).



  Subpart E_Quality Measures, Beneficiary Protections, and Compliance 
                               Enforcement



Sec. 510.400  Quality measures and reporting.

    (a) Reporting of quality measures. The following quality measures 
are used for public reporting, for determining whether a participant 
hospital is eligible for reconciliation payments under Sec. 510.305(g), 
and whether a participant hospital is eligible for quality incentive 
payments under Sec. 510.315(f) in the performance year or performance 
year subset:
    (1) Hospital-level risk-standardized complication rate following 
elective primary total hip arthroplasty and/or total knee arthroplasty.
    (2) Hospital Consumer Assessment of Healthcare Providers and Systems 
Survey.
    (b) Requirements for successful voluntary data submission of 
patient-reported outcomes and limited risk variable data. To be eligible 
to receive the additional points added to the composite quality score 
for successful voluntary data submission of patient-reported outcomes 
and limited risk variable data, as described in Sec. 510.315(b)(4), 
participant hospitals must submit the THA/TKA patient-reported outcome 
and limited risk variable data requested by CMS related to the pre- and 
post-operative periods for elective primary total hip and/or total knee 
arthroplasty procedures. The data must be submitted within 60 days of 
the end of the most recent performance period and be accompanied by the 
patient-reported outcomes and limited risk variable data (eleven 
elements finalized) as outlined in Sec. 510.315(b)(4).
    (1) For each eligible procedure all eleven risk variable data 
elements are required to be submitted. The eleven risk variables are as 
follows:
    (i) Date of birth.
    (ii) Race.
    (iii) Ethnicity.
    (iv) Date of admission to anchor hospitalization.
    (v) Date of eligible THA/TKA procedure.
    (vi) Medicare Health Insurance Claim Number.
    (vii) Body mass index.
    (viii) Use of chronic (=90 day) narcotics.
    (ix) Total painful joint count.
    (x) Quantified spinal pain.
    (xi) Single Item Health Literacy Screening (SILS2) questionnaire.
    (2) Hospitals must also submit the amount of requested THA/TKA 
patient-reported outcomes data required for each performance year or 
performance year subset of the model in order to be considered 
successful in submitting voluntary data.
    (i) The amount of requested THA/TKA patient-reported outcomes data 
to submit, in order to be considered successful will increase each 
subsequent year of the model over the first 5 years of the model (with 
the exception of performance year subset 5.2, for which CMS will request 
the same amount of THA/TKA patient-reported outcomes data as performance 
year subset 5.1, updated to reflect the timeframe applicable to 
performance year subset 5.2).
    (ii) A phase-in approach that determines the amount of requested 
THA/TKA patient-reported outcomes data to submit over performance years 
1 through 4 and performance year subset 5.1 (with the exception of 
performance year subset 5.2, for which CMS will request the same amount 
of THA/TKA patient-reported outcomes as performance year subset 5.1, 
updated to reflect the timeframe applicable to performance year subset 
5.2) of the model will be applied so that in year 1 successful 
submission of data would mean CMS received all requested THA/TKA 
patient-reported outcomes and limited risk variable data on both of the 
following:
    (A) Greater than or equal to 50 percent of eligible procedures or 
greater than or equal to 50 eligible patients during the data collection 
period.
    (B) Submission of requested THA/TKA PRO and limited risk variable

[[Page 925]]

data is completed within 60 days of the most recent performance period.
    (3) For years 1 through 5 of the model an increasing amount of data 
is requested by CMS for each performance period as follows:
    (i) Year 1 (2016). Submit pre-operative data on primary elective 
THA/TKA procedures for =50% or =50 eligible 
procedures performed between July 1, 2016 and August 31, 2016, unless 
CMS requests a more limited data set, in which case, submit all 
requested data elements.
    (ii) Year 2 (2017). Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=50% or =50 eligible procedures performed between 
July 1, 2016 through August 31, 2016; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=60% or =75 procedures performed between September 
1, 2016 through June 30, 2017, unless CMS requests a more limited data 
set, in which case, submit all requested data elements.
    (iii) Year 3 (2018). Submit--
    (A) POST-operative data on primary elective THA/TKA procedures for 
=60% or =75 procedures performed between September 
1, 2016 and June 30, 2017; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=70% or =100 procedures performed between July 1, 
2017 and June 30, 2018, unless CMS requests a more limited data set, in 
which case, submit all requested data elements.
    (iv) Year 4 (2019). Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=70% or =100 procedures performed between July 1, 
2017 and June 30, 2018; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=80% or =200 procedures performed between July 1, 
2018 and June 30, 2019, unless CMS requests a more limited data set, in 
which case, submit all requested data elements.
    (v) Year 5 (subset 5.1, January 1, 2020-December 31, 2020). Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=80% or =200 procedures performed between July 1, 
2018 and June 30, 2019 and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=80% or =200 procedures performed between July 1, 
2019 and June 30, 2020, unless CMS requests a more limited data set, in 
which case, submit all requested data elements.
    (vi) Year 5 (subset 5.2, January 1, 2021-September 30, 2021). 
Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=80% or =200 procedures performed between July 1, 
2019 and June 30, 2020; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=80% or =200 procedures performed between July 1, 
2020 and June 30, 2021, unless CMS requests a more limited data set, in 
which case, submit all requested data elements.
    (4) For years 6 through 8 of the model the following data are 
requested by CMS for each performance period as follows:
    (i) Year 6 (October 1, 2021 to December 31, 2022). Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=80% or =200 procedures performed between July 1, 
2019 and June 30, 2020; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=80% or =300 procedures performed between July 1, 
2021 and June 30, 2022.
    (ii) Year 7 (2023). Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=80% or =300 procedures performed between July 1, 
2021 and June 30, 2022; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=85% or =400 procedures performed between July 1, 
2022 and June 30, 2023.
    (iii) Year 8 (2024). Submit--
    (A) Post-operative data on primary elective THA/TKA procedures for 
=85% or =400 procedures performed between July 1, 
2022 and June 30, 2023; and
    (B) Pre-operative data on primary elective THA/TKA procedures for 
=90% or =500 procedures performed between July 1, 
2023 and June 30, 2024.
    (c) Public reporting. CMS--
    (1) Makes the quality measurement results calculated for the 
complication and patient survey quality measures described in paragraph 
(a) of this section for each participant hospital in each performance 
year publicly available on the CMS Web site in a form and manner as 
determined by CMS;

[[Page 926]]

    (2) Shares each participant hospital's quality metrics with the 
hospital prior to display on the Web site; and
    (3) Does not publicly report the voluntary patient-reported outcomes 
and limited risk variable data during this model, but indicates whether 
a hospital has successfully submitted such data in accordance with Sec. 
510.400(b).

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 615, Jan. 3, 2017; 85 
FR 71201, Nov. 6, 2020; 86 FR 23574, May 3, 2021; 86 FR 36229, July 9, 
2021]



Sec. 510.405  Beneficiary choice and beneficiary notification.

    (a) Beneficiary choice. The CJR model does not restrict Medicare 
beneficiaries' ability to choose any Medicare enrolled provider or 
supplier, or any physician or practitioner who has opted out of 
Medicare.
    (1) As part of discharge planning and referral, participant 
hospitals must provide a complete list of HHAs, SNFs, IRFs, or LTCHs 
that are participating in the Medicare program, and that serve the 
geographic area (as defined by the HHA) in which the patient resides, or 
in the case of a SNF, IRF, or LTCH, in the geographic area requested by 
the patient.
    (i) This list must be presented to CJR beneficiaries for whom home 
health care, SNF, IRF, or LTCH services are medically necessary.
    (ii) Participant hospitals must specify on the list those post-acute 
care providers on the list with whom they have a sharing arrangement.
    (iii) Participant hospitals may recommend preferred providers and 
suppliers, consistent with applicable statutes and regulations.
    (iv) Participant hospitals may not limit beneficiary choice to any 
list of providers or suppliers in any manner other than that permitted 
under applicable statutes and regulations.
    (v) Participant hospitals must take into account patient and family 
preferences when they are expressed.
    (2) Participant hospitals may not charge any CJR collaborator a fee 
to be included on any list of preferred providers or suppliers, nor may 
the participant hospital accept such payments.
    (b) Required beneficiary notification--(1) Participant hospital 
beneficiary notification--(i) Notification to beneficiaries. Each 
participant hospital must provide written notification to any Medicare 
beneficiary that meets the criteria in Sec. 510.205 of his or her 
inclusion in the CJR model.
    (ii) Timing of notification. Prior to discharge from the anchor 
hospitalization, or prior to discharge from the anchor procedure, as 
applicable, the participant hospital must provide the CJR beneficiary 
with a participant hospital beneficiary notification as described in 
paragraph (b)(1)(iv) of this section.
    (iii) List of beneficaries receiving a notification. The participant 
hospital must be able to generate a list of all beneficiaries receiving 
such notification, including the date on which the notification was 
provided to the beneficiary, to CMS or its designee upon request.
    (iv) Content of notification. The beneficiary notification must 
contain all of the following:
    (A) A detailed explanation of the model and how it might be expected 
to affect the beneficiary's care.
    (B) Notification that the beneficiary retains freedom of choice to 
choose providers and services.
    (C) Explanation of how patients can access care records and claims 
data through an available patient portal, and how they can share access 
to their Blue Button[supreg] electronic health information with 
caregivers.
    (D) A statement that all existing Medicare beneficiary protections 
continue to be available to the beneficiary. These include the ability 
to report concerns of substandard care to Quality Improvement 
Organizations or the 1-800-MEDICARE helpline.
    (E) A list of the providers, suppliers, and ACOs with whom the CJR 
participant hospital has a sharing arrangement. This requirement may be 
fulfilled by the participant hospital including in the detailed 
notification a Web address where beneficiaries may access the list.
    (2) CJR collaborator notice. A participant hospital must require 
every CJR collaborator to provide written notice to applicable CJR 
beneficiaries of the structure of the CJR model and the existence of its 
sharing arrangement with the participant hospital.

[[Page 927]]

    (i) With the exception of ACOs, PGPs, NPPGPs, and TGPs, a CJR 
participant hospital must require every CJR collaborator that furnishes 
an item or service to a CJR beneficiary during a CJR episode to provide 
written notice to the beneficiary of the structure of the model and the 
existence of the individual's or entity's sharing arrangement. The 
notice must be provided no later than the time at which the beneficiary 
first receives an item or service from the CJR collaborator during a CJR 
episode. In circumstances where, due to the patient's condition, it is 
not feasible to provide notification at such time, the notification must 
be provided to the beneficiary or his or her representative as soon as 
is reasonably practicable. The CJR collaborator must be able to generate 
a list of all beneficiaries who received such a notice, including the 
date on which the notice was provided to the beneficiary, to CMS upon 
request.
    (ii) A participant hospital must require every PGP, NPPGP, or TGP 
that is a CJR collaborator where a member of the PGP, member of the 
NPPGP, or member of the TGP furnishes an item or service to a CJR 
beneficiary during a CJR episode to provide written notice to the 
beneficiary of the structure of the model and the existence of the 
entity's sharing arrangement. The notice must be provided no later than 
the time at which the beneficiary first receives an item or service from 
any member of the PGP, member of the NPPGP, or member of the TGP, and 
the required PGP, NPPGP, or TGP notice may be provided by that member 
respectively. In circumstances where, due to the patient's condition, it 
is not feasible to provide notice at such times, the notice must be 
provided to the beneficiary or his or her representative as soon as is 
reasonably practicable. The PGP, NPPGP, or TGP must be able to generate 
a list of all beneficiaries who received such a notice, including the 
date on which the notice was provided to the beneficiary, to CMS upon 
request.
    (iii) A participant hospital must require every ACO that is a CJR 
collaborator where an ACO participant or ACO provider/supplier furnishes 
an item or service to a CJR beneficiary during a CJR episode to provide 
written notice to the beneficiary of the structure of the model and the 
existence of the entity's sharing arrangement. The notice must be 
provided no later than the time at which the beneficiary first receives 
an item or service from any ACO participant or ACO provider/supplier and 
the required ACO notice may be provided by that ACO participant or ACO 
provider/supplier respectively. In circumstances where, due to the 
patient's condition, it is not feasible to provide notice at such times, 
the notice must be provided to the beneficiary or his or her 
representative as soon as is reasonably practicable. The ACO must be 
able to generate a list of all beneficiaries who received such a notice, 
including the date on which the notice was provided to the beneficiary, 
to CMS upon request.
    (3) Discharge planning notice. A participant hospital must provide 
the beneficiary with a written notice of any potential financial 
liability associated with non-covered services recommended or presented 
as an option as part of discharge planning, no later than the time that 
the beneficiary discusses a particular post-acute care option or at the 
time the beneficiary is discharged from an anchor procedure or anchor 
hospitalization, whichever occurs earlier.
    (i) If the participant hospital knows or should have known that the 
beneficiary is considering or has decided to receive a non-covered post-
acute care service or other non-covered associated service or supply, 
the participant hospital must notify the beneficiary that the service 
would not be covered by Medicare.
    (ii) If the participant hospital is discharging a beneficiary to a 
SNF prior to the occurrence of a 3-day hospital stay, and the 
beneficiary is being transferred to or is considering a SNF that would 
not qualify under the SNF 3-day waiver in Sec. 510.610, the participant 
hospital must notify the beneficiary in accordance with paragraph 
(b)(3)(i) of this section that the beneficiary will be responsible for 
payment for the services furnished by the SNF during that stay, except 
those services that would be covered by Medicare

[[Page 928]]

Part B during a non-covered inpatient SNF stay.
    (4) Access to records and retention. Lists of beneficiaries that 
receive notifications or notices must be retained, and access provided 
to CMS, or its designees, in accordance with Sec. 510.110.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 616, Jan. 3, 2017; 86 
FR 23574, May 3, 2021]



Sec. 510.410  Compliance enforcement.

    (a) General. Participant hospitals must comply with all of the 
requirements outlined in this part. Except as specifically noted in this 
part, the regulations under this part must not be construed to affect 
the payment, coverage, program integrity, or other requirements (such as 
those in parts 412 and 482 of this chapter) that apply to providers and 
suppliers under this chapter.
    (b) Failure to comply. (1) CMS may take one or more of the remedial 
actions set forth in paragraph (b)(2) of this section if a participant 
hospital or its related CJR collaborators, collaboration agents, or 
downstream collaboration agents--
    (i) Fails to comply with any requirements of this part or is 
identified as noncompliant through monitoring by HHS (including CMS and 
OIG) of the CJR model, including but not limited to the following:
    (A) Avoiding potentially high cost patients.
    (B) Targeting potentially low cost patients.
    (C) Failing to provide medically appropriate services or 
systematically engaging in the over or under delivery of appropriate 
care.
    (D) Failing to provide beneficiaries with complete and accurate 
information, including required notices.
    (E) Failing to allow beneficiary choice of medically necessary 
options, including non-surgical options.
    (F) Failing to follow the requirements related to sharing 
arrangements.
    (G) Failing to participate in CJR model-related evaluation 
activities conducted by CMS or its contractors or both.
    (ii) Has signed a sharing arrangement, distribution arrangement, or 
downstream distribution arrangement that is noncompliant with the 
requirements of this part.
    (iii) Takes any action that threatens the health or safety of 
patients;
    (iv) Avoids at-risk Medicare beneficiaries, as this term is defined 
in Sec. 425.20;
    (v) Avoids patients on the basis of payer status;
    (vi) Is subject to sanctions or final actions of an accrediting 
organization or federal, state, or local government agency that could 
lead to the inability to comply with the requirements and provisions of 
this part;
    (vii) Takes any action that CMS determines for program integrity 
reasons is not in the best interests of the CJR model, or fails to take 
any action that CMS determines for program integrity reasons should have 
been taken to further the best interests of the CJR model;
    (viii) Is subject to action by HHS (including OIG and CMS) or the 
Department of Justice to redress an allegation of fraud or significant 
misconduct, including intervening in a False Claims Act qui tam matter, 
issuing a pre-demand or demand letter under a civil sanction authority, 
or similar actions; or
    (ix) Is subject to action involving violations of the physician 
self-referral law, civil monetary penalties law, federal anti-kickback 
statute, antitrust laws, or any other applicable Medicare laws, rules, 
or regulations that are relevant to the CJR model.
    (2) Remedial actions include the following:
    (i) Issuing a warning letter to the participant hospital.
    (ii) Requiring the participant hospital to develop a corrective 
action plan, commonly referred to as a CAP.
    (iii) Reducing or eliminating a participant hospital's 
reconciliation payment.
    (iv) Requiring a participant hospital to terminate a sharing 
arrangement with a CJR collaborator and prohibiting further engagement 
in sharing arrangements with the participant hospital by that CJR 
collaborator.
    (v) Terminating the participant hospital's participation in the CJR 
model. Where a participant is terminated from

[[Page 929]]

the CJR model, the participant hospital will remain liable for all 
negative NPRA generated from episodes of care that ended prior to 
termination.
    (3) CMS may add a 25 percent penalty to a repayment amount on the 
participant hospital's reconciliation report if all of the following 
conditions are met:
    (i) CMS has required a corrective action plan from a participant 
hospital;
    (ii) The participant hospital owes a repayment amount to CMS; and
    (iii) The participant hospital fails to timely comply with the 
corrective action plan or is noncompliant with the CJR model's 
requirements.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 617, Jan. 3, 2017; 82 
FR 57104, Dec. 1, 2017]



       Subpart F_Financial Arrangements and Beneficiary Incentives



Sec. 510.500  Sharing arrangements under the CJR model.

    (a) General. (1) A participant hospital may enter into a sharing 
arrangement with a CJR collaborator to make a gainsharing payment, or to 
receive an alignment payment, or both. A participant hospital must not 
make a gainsharing payment or receive an alignment payment except in 
accordance with a sharing arrangement.
    (2) A sharing arrangement must comply with the provisions of this 
section and all other applicable laws and regulations, including the 
applicable fraud and abuse laws and all applicable payment and coverage 
requirements.
    (3) Participant hospitals must develop, maintain, and use a set of 
written policies for selecting individuals and entities to be CJR 
collaborators. These policies must contain criteria related to, and 
inclusive of, the quality of care delivered by the potential CJR 
collaborator. The selection criteria cannot be based directly or 
indirectly on the volume or value of past or anticipated referrals or 
business otherwise generated by, between or among the participant 
hospital, any CJR collaborator, any collaboration agent, any downstream 
collaboration agent, or any individual or entity affiliated with a 
participant hospital, CJR collaborator, collaboration agent, or 
downstream collaboration agent. A selection criterion that considers 
whether a potential CJR collaborator has performed a reasonable minimum 
number of services that would qualify as CJR activities will be deemed 
not to violate the volume or value standard if the purpose of the 
criterion is to ensure the quality of care furnished to CJR 
beneficiaries.
    (4) If a participant hospital enters into a sharing arrangement, its 
compliance program must include oversight of sharing arrangements and 
compliance with the applicable requirements of the CJR model.
    (b) Requirements. (1) A sharing arrangement must be in writing and 
signed by the parties, and entered into before care is furnished to CJR 
beneficiaries under the sharing arrangement.
    (2) Participation in a sharing arrangement must be voluntary and 
without penalty for nonparticipation.
    (3) The sharing arrangement must require the CJR collaborator and 
its employees, contractors (including collaboration agents), and 
subcontractors (including downstream collaboration agents) to comply 
with all of the following:
    (i) The applicable provisions of this part (including requirements 
regarding beneficiary notifications, access to records, record 
retention, and participation in any evaluation, monitoring, compliance, 
and enforcement activities performed by CMS or its designees).
    (ii) All applicable Medicare provider enrollment requirements at 
Sec. 424.500 of this chapter, including having a valid and active TIN 
or NPI, during the term of the sharing arrangement.
    (iii) All other applicable laws and regulations.
    (4) The sharing arrangement must require the CJR collaborator to 
have or be covered by a compliance program that includes oversight of 
the sharing arrangement and compliance with the requirements of the CJR 
model that apply to its role as a CJR collaborator, including any 
distribution arrangements.
    (5) The sharing arrangement must not pose a risk to beneficiary 
access, beneficiary freedom of choice, or quality of care.

[[Page 930]]

    (6) The board or other governing body of the participant hospital 
must have responsibility for overseeing the participant hospital's 
participation in the CJR model, its arrangements with CJR collaborators, 
its payment of gainsharing payments, its receipt of alignment payments, 
and its use of beneficiary incentives in the CJR model.
    (7) The written agreement memorializing a sharing arrangement must 
specify the following:
    (i) The purpose and scope of the sharing arrangement.
    (ii) The obligations of the parties, including specified CJR 
activities and other services to be performed by the parties under the 
sharing arrangement.
    (iii) The date of the sharing arrangement.
    (iv) The financial or economic terms for payment, including the 
following:
    (A) Eligibility criteria for a gainsharing payment.
    (B) Eligibility criteria for an alignment payment.
    (C) Frequency of gainsharing or alignment payment.
    (D) Methodology and accounting formula for determining the amount of 
a gainsharing payment or alignment payment.
    (8) The sharing arrangement must not--
    (i) Induce the participant hospital, CJR collaborator, or any 
employees, contractors, or subcontractors of the participant hospital or 
CJR collaborator to reduce or limit medically necessary services to any 
Medicare beneficiary; or
    (ii) Restrict the ability of a CJR collaborator to make decisions in 
the best interests of its patients, including the selection of devices, 
supplies, and treatments.
    (c) Gainsharing payment, alignment payment, and internal cost 
savings conditions and restrictions. (1) Gainsharing payments, if any, 
must--
    (i) Be derived solely from reconciliation payments, or internal cost 
savings, or both;
    (ii) Be distributed on an annual basis (not more than once per 
calendar year);
    (iii) Not be a loan, advance payment, or payment for referrals or 
other business; and
    (iv) Be clearly identified as a gainsharing payment at the time it 
is paid.
    (2)(i) To be eligible to receive a gainsharing payment, a CJR 
collaborator must meet quality of care criteria for the performance year 
for which the participant hospital accrued the internal cost savings or 
earned the reconciliation payment that comprises the gainsharing 
payment. The quality of care criteria must be established by the 
participant hospital and directly related to the CJR episode.
    (ii) To be eligible to receive a gainsharing payment, or to be 
required to make an alignment payment, a CJR collaborator other than 
ACO, PGP, NPPGP, or TGP must have directly furnished a billable item or 
service to a CJR beneficiary during a CJR episode that occurred in the 
same performance year for which the participant hospital accrued the 
internal cost savings or earned the reconciliation payment that 
comprises the gainsharing payment or was assessed a repayment amount.
    (iii) To be eligible to receive a gainsharing payment, or to be 
required to make an alignment payment, a CJR collaborator that is a PGP, 
NPPGP, or TGP must meet the following criteria:
    (A) The PGP, NPPGP, or TGP must have billed for an item or service 
that was rendered by one or more PGP member, NPPGP member, or TGP member 
respectively to a CJR beneficiary during a CJR episode that occurred 
during the same performance year for which the participant hospital 
accrued the internal cost savings or earned the reconciliation payment 
that comprises the gainsharing payment or was assessed a repayment 
amount.
    (B) The PGP, NPPGP, or TGP must have contributed to CJR activities 
and been clinically involved in the care of CJR beneficiaries during the 
same performance year for which the CJR participant hospital accrued the 
internal cost savings or earned the reconciliation payment that 
comprises the gainsharing payment or was assessed a repayment amount. 
For example, a PGP, NPPGP, or TGP might have been clinically involved in 
the care of CJR beneficiaries by--

[[Page 931]]

    (1) Providing care coordination services to beneficiaries during 
and/or after inpatient admission;
    (2) Engaging with a participant hospital in care redesign 
strategies, and actually performing a role in implementing such 
strategies, that are designed to improve the quality of care for CJR 
episodes and reduce CJR episode spending; or
    (3) In coordination with other providers and suppliers (such as PGP 
members, NPPGP members, or TGP members; the participant hospital; and 
post-acute care providers), implementing strategies designed to address 
and manage the comorbidities of CJR beneficiaries.
    (iv) To be eligible to receive a gainsharing payment, or to be 
required to make an alignment payment, a CJR collaborator that is an ACO 
must meet the following criteria:
    (A) The ACO must have had an ACO provider/supplier that directly 
furnished, or an ACO participant that billed for, an item or service 
that was rendered to a CJR beneficiary during a CJR episode that 
occurred during the same performance year for which the participant 
hospital accrued the internal cost savings or earned the reconciliation 
payment that comprises the gainsharing payment or was assessed a 
repayment amount; and
    (B) The ACO must have contributed to CJR activities and been 
clinically involved in the care of CJR beneficiaries during the same 
performance year for which the participant hospital accrued the internal 
cost savings or earned the reconciliation payment that comprises the 
gainsharing payment or was assessed the repayment amount. For example, 
an ACO might be have been clinically involved in the care of CJR 
beneficiaries by--
    (1) Providing care coordination services to CJR beneficiaries during 
and/or after inpatient admission;
    (2) Engaging with a participant hospital in care redesign 
strategies, and actually performing a role in implementing such 
strategies, that are designed to improve the quality of care and reduce 
spending for CJR episodes; or
    (3) In coordination with providers and suppliers (such as ACO 
participants, ACO providers/suppliers, the participant hospital, and 
post-acute care providers), implementing strategies designed to address 
and manage the comorbidities of CJR beneficiaries.
    (3)(i) The methodology for accruing, calculating and verifying 
internal cost savings must be transparent, measurable, and verifiable in 
accordance with generally accepted accounting principles (GAAP) and 
Government Auditing Standards (The Yellow Book).
    (ii) The methodology used to calculate internal cost savings must 
reflect the actual, internal cost savings achieved by the participant 
hospital through the documented implementation of CJR activities 
identified by the participant hospital and must exclude--
    (A) Any savings realized by any individual or entity that is not the 
participant hospital; and
    (B) ``Paper'' savings from accounting conventions or past investment 
in fixed costs.
    (4) The total amount of a gainsharing payment for a performance year 
paid to a CJR collaborator must not exceed the following:
    (i) For episodes beginning on or after April 1, 2016 and ending on 
or before September 30, 2021, in the case of a CJR collaborator who is a 
physician or non-physician practitioner, 50 percent of the Medicare-
approved amounts under the PFS for items and services furnished by that 
physician or non-physician practitioner to the participant hospital's 
CJR beneficiaries during CJR model episodes that occurred during the 
same performance year for which the participant hospital accrued the 
internal cost savings or earned the reconciliation payment that 
comprises the gainsharing payment being made.
    (ii) For episodes beginning on or after April 1, 2016 and ending on 
or before September 30, 2021, in the case of a CJR collaborator that is 
a PGP or NPPGP, 50 percent of the Medicare-approved amounts under the 
PFS for items and services billed by that PGP or NPPGP and furnished to 
the participant hospital's CJR beneficiaries by the PGP members or NPPGP 
members respectively during CJR model episodes that occurred during the 
same performance year for which the participant hospital

[[Page 932]]

accrued the internal cost savings or earned the reconciliation payment 
that comprises the gainsharing payment being made.
    (5) The amount of any gainsharing payments must be determined in 
accordance with a methodology that is substantially based on quality of 
care and the provision of CJR activities. The methodology may take into 
account the amount of such CJR activities provided by a CJR collaborator 
relative to other CJR collaborators.
    (6) For a performance year, the aggregate amount of all gainsharing 
payments that are derived from a reconciliation payment the CJR 
participant hospital receives from CMS must not exceed the amount of 
that reconciliation payment.
    (7) No entity or individual, whether a party to a sharing 
arrangement or not, may condition the opportunity to make or receive 
gainsharing payments or to make or receive alignment payments directly 
or indirectly on the volume or value of past or anticipated referrals or 
business otherwise generated by, between or among the participant 
hospital, any CJR collaborator, any collaboration agent, any downstream 
collaboration agent, or any individual or entity affiliated with a 
participant hospital, CJR collaborator, collaboration agent, or 
downstream collaboration agent.
    (8) A participant hospital must not make a gainsharing payment to a 
CJR collaborator if CMS has notified the participant hospital that such 
collaborator is subject to any action for noncompliance with this part 
or the fraud and abuse laws, or for the provision of substandard care to 
CJR beneficiaries or other integrity problems.
    (9) The sharing arrangement must require the participant hospital to 
recoup any gainsharing payment that contained funds derived from a CMS 
overpayment on a reconciliation report or was based on the submission of 
false or fraudulent data.
    (10) Alignment payments from a CJR collaborator to a participant 
hospital may be made at any interval that is agreed upon by both 
parties, and must not be--
    (i) Issued, distributed, or paid prior to the calculation by CMS of 
a repayment amount reflected in a reconciliation report;
    (ii) Loans, advance payments, or payments for referrals or other 
business; or
    (iii) Assessed by a participant hospital if it does not owe a 
repayment amount.
    (11) The participant hospital must not receive any amounts under a 
sharing arrangement from a CJR collaborator that are not alignment 
payments.
    (12) For a performance year, the aggregate amount of all alignment 
payments received by the participant hospital must not exceed 50 percent 
of the participant hospital's repayment amount.
    (13) The aggregate amount of all alignment payments from a CJR 
collaborator to the participant hospital may not be greater than--
    (i) With respect to a CJR collaborator other than an ACO, 25 percent 
of the participant hospital's repayment amount.
    (ii) With respect to a CJR collaborator that is an ACO, 50 percent 
of the participant hospital's repayment amount.
    (14) The amount of any alignment payments must be determined in 
accordance with a methodology that does not directly account for the 
volume or value of past or anticipated referrals or business otherwise 
generated by, between or among the participant hospital, any CJR 
collaborator, any collaboration agent, any downstream collaboration 
agent, or any individual or entity affiliated with a participant 
hospital, CJR collaborator, collaboration agent, or downstream 
collaboration agent.
    (15) All gainsharing payments and any alignment payments must be 
administered by the participant hospital in accordance with generally 
accepted accounting principles (GAAP) and Government Auditing Standards 
(The Yellow Book).
    (16) All gainsharing payments and alignment payments must be made by 
check, electronic funds transfer, or another traceable cash transaction.

[[Page 933]]

    (d) Documentation requirements. (1) Participant hospitals must--(i) 
Document the sharing arrangement contemporaneously with the 
establishment of the arrangement;
    (ii) Publicly post (and update on at least a quarterly basis) on a 
Web page on the CJR participant hospital's Web site--
    (A) Accurate current and historical lists of all CJR collaborators, 
including CJR collaborator names and addresses.
    (B) Written policies for selecting individuals and entities to be 
CJR collaborators required by Sec. 510.500(a)(3).
    (iii) Maintain and require each CJR collaborator to maintain 
contemporaneous documentation with respect to the payment or receipt of 
any gainsharing payment or alignment payment that includes at a minimum:
    (A) Nature of the payment (gainsharing payment or alignment 
payment);
    (B) Identity of the parties making and receiving the payment;
    (C) Date of the payment;
    (D) Amount of the payment;
    (E) Date and amount of any recoupment of all or a portion of a CJR 
collaborator's gainsharing payment.
    (F) Explanation for each recoupment, such as whether the CJR 
collaborator received a gainsharing payment that contained funds derived 
from a CMS overpayment on a reconciliation report, or was based on the 
submission of false or fraudulent data.
    (2) The participant hospital must keep records of all of the 
following:
    (i) Its process for determining and verifying its potential and 
current CJR collaborators' eligibility to participate in Medicare.
    (ii) Its plan to track internal cost savings.
    (iii) Information on the accounting systems used to track internal 
cost savings.
    (iv) A description of current health information technology, 
including systems to track reconciliation payments and internal cost 
savings.
    (v) Its plan to track gainsharing payments and alignment payments.
    (3) The participant hospital must retain and provide access to, and 
must require each CJR collaborator to retain and provide access to, the 
required documentation in accordance with Sec. 510.110.

[82 FR 617, Jan. 3, 2017, as amended at 86 FR 23575, May 3, 2021]



Sec. 510.505  Distribution arrangements.

    (a) General. (1) An ACO, PGP, NPPGP, or TGP that has entered into a 
sharing arrangement with a participant hospital may distribute all or a 
portion of any gainsharing payment it receives from the participant 
hospital only in accordance with a distribution arrangement.
    (2) All distribution arrangements must comply with the provisions of 
this section and all other applicable laws and regulations, including 
the fraud and abuse laws.
    (b) Requirements. (1) All distribution arrangements must be in 
writing and signed by the parties, contain the date of the agreement, 
and be entered into before care is furnished to CJR beneficiaries under 
the distribution arrangement.
    (2) Participation in a distribution arrangement must be voluntary 
and without penalty for nonparticipation.
    (3) The distribution arrangement must require the collaboration 
agent to comply with all applicable laws and regulations.
    (4) The opportunity to make or receive a distribution payment must 
not be conditioned directly or indirectly on the volume or value of past 
or anticipated referrals or business otherwise generated by, between or 
among the participant hospital, any CJR collaborator, any collaboration 
agent, any downstream collaboration agent, or any individual or entity 
affiliated with a participant hospital, CJR collaborator, collaboration 
agent, or downstream collaboration agent.
    (5) The amount of any distribution payments from an ACO, from an 
NPPGP to an NPPGP member, or from a TGP to a TGP member must be 
determined in accordance with a methodology that is substantially based 
on quality of care and the provision of CJR activities and that may take 
into account the amount of such CJR activities provided by a 
collaboration agent relative to other collaboration agents.

[[Page 934]]

    (6) The amount of any distribution payments from a PGP must be 
determined either in a manner that complies with Sec. 411.352(g) of 
this chapter or in accordance with a methodology that is substantially 
based on quality of care and the provision of CJR activities and that 
may take into account the amount of such CJR activities provided by a 
collaboration agent relative to other collaboration agents.
    (7) Except for a distribution payment from a PGP to a PGP member 
that complies with Sec. 411.352(g) of this chapter, a collaboration 
agent is eligible to receive a distribution payment only if the 
collaboration agent furnished or billed for an item or service rendered 
to a CJR beneficiary during a CJR episode that occurred during the same 
performance year for which the participant hospital accrued the internal 
cost savings or earned the reconciliation payment that comprises the 
gainsharing payment being distributed.
    (8) Except for a distribution payment from a PGP to a PGP member 
that complies with Sec. 411.352(g) of this chapter, the total amount of 
distribution payments for a performance year paid to a collaboration 
agent must not exceed the following:
    (i) For episodes beginning on or after April 1, 2016 and ending on 
or before September 30, 2021, in the case of a collaboration agent that 
is a physician or non-physician practitioner, 50 percent of the total 
Medicare-approved amounts under the PFS for items and services furnished 
by the collaboration agent to the participant hospital's CJR 
beneficiaries during CJR model episodes that occurred during the same 
performance year for which the participant hospital accrued the internal 
cost savings or earned the reconciliation payment that comprises the 
gainsharing payment being distributed.
    (ii) For episodes beginning on or after April 1, 2016 and ending on 
or before September 30, 2021, in the case of a collaboration agent that 
is a PGP or NPPGP, 50 percent of the total Medicare-approved amounts 
under the PFS for items and services billed by that PGP or NPPGP for 
items and services furnished by PGP members or NPPGP member respectively 
to the participant hospital's CJR beneficiaries during CJR model 
episodes that occurred during the same performance year for which the 
participant hospital accrued the internal cost savings or earned the 
reconciliation payment that comprises the gainsharing payment being 
distributed.
    (9) With respect to the distribution of any gainsharing payment 
received by an ACO, PGP, NPPGP, or TGP, the total amount of all 
distribution payments must not exceed the amount of the gainsharing 
payment received by the CJR collaborator from the participant hospital.
    (10) All distribution payments must be made by check, electronic 
funds transfer, or another traceable cash transaction.
    (11) The collaboration agent must retain the ability to make 
decisions in the best interests of the patient, including the selection 
of devices, supplies, and treatments.
    (12) The distribution arrangement must not--
    (i) Induce the collaboration agent to reduce or limit medically 
necessary items and services to any Medicare beneficiary; or
    (ii) Reward the provision of items and services that are medically 
unnecessary.
    (13) The CJR collaborator must maintain contemporaneous 
documentation regarding distribution arrangements in accordance with 
Sec. 510.110, including the following:
    (i) The relevant written agreements;
    (ii) The date and amount of any distribution payment(s);
    (iii) The identity of each collaboration agent that received a 
distribution payment; and
    (iv) A description of the methodology and accounting formula for 
determining the amount of any distribution payment.
    (14) The CJR collaborator may not enter into a distribution 
arrangement with any individual or entity that has a sharing arrangement 
with the same participant hospital.
    (15) The CJR collaborator must retain and provide access to, and 
must require collaboration agents to retain

[[Page 935]]

and provide access to, the required documentation in accordance with 
Sec. 510.110.

[82 FR 620, Jan. 3, 2017, as amended at 86 FR 23575, May 3, 2021]



Sec. 510.506  Downstream distribution arrangements.

    (a) General. (1) An ACO participant that is a PGP, NPPGP, or TGP and 
that has entered into a distribution arrangement with a CJR collaborator 
that is an ACO may distribute all or a portion of any distribution 
payment it receives from the CJR collaborator only in accordance with 
downstream distribution arrangement.
    (2) All downstream distribution arrangements must comply with the 
provisions of this section and all applicable laws and regulations, 
including the fraud and abuse laws.
    (b) Requirements. (1) All downstream distribution arrangements must 
be in writing and signed by the parties, contain the date of the 
agreement, and be entered into before care is furnished to CJR 
beneficiaries under the downstream distribution arrangement.
    (2) Participation in a downstream distribution arrangement must be 
voluntary and without penalty for nonparticipation.
    (3) The downstream distribution arrangement must require the 
downstream collaboration agent to comply with all applicable laws and 
regulations.
    (4) The opportunity to make or receive a downstream distribution 
payment must not be conditioned directly or indirectly on the volume or 
value of past or anticipated referrals or business otherwise generated 
by, between or among the participant hospital, any CJR collaborator, any 
collaboration agent, any downstream collaboration agent, or any 
individual or entity affiliated with a participant hospital, CJR 
collaborator, collaboration agent, or downstream collaboration agent.
    (5) The amount of any downstream distribution payments from an NPPGP 
to an NPPGP member or from a TGP to a TGP member must be determined in 
accordance with a methodology that is substantially based on quality of 
care and the provision CJR activities and that may take into account the 
amount of such CJR activities provided by a downstream collaboration 
agent relative to other downstream collaboration agents.
    (6) The amount of any downstream distribution payments from a PGP 
must be determined either in a manner that complies with Sec. 
411.352(g) of this chapter or in accordance with a methodology that is 
substantially based on quality of care and the provision CJR activities 
and that may take into account the amount of such CJR activities 
provided by a downstream collaboration agent relative to other 
downstream collaboration agents.
    (7) Except for a downstream distribution payment from a PGP to a PGP 
member that complies with Sec. 411.352(g) of this chapter, a downstream 
collaboration agent is eligible to receive a downstream distribution 
payment only if the downstream collaboration agent furnished an item or 
service by the downstream collaboration agent to a CJR beneficiary 
during a CJR episode that occurred during the same performance year for 
which the participant hospital accrued the internal cost savings or 
earned the reconciliation payment that comprises the gainsharing payment 
from which the ACO made the distribution payment to the PGP, NPPGP, or 
TGP that is an ACO participant.
    (8) Except for a downstream distribution payment from a PGP to a PGP 
member that complies with Sec. 411.352(g) of this chapter, for episodes 
beginning on or after April 1, 2016 and ending on or before September 
30, 2021 the total amount of downstream distribution payments for a 
performance year paid to a downstream collaboration agent who is a 
physician or non-physician practitioner and is either a member of a PGP 
or a member of an NPPGP must not exceed 50 percent of the total 
Medicare-approved amounts under the PFS for items and services furnished 
by the downstream collaboration agent to the participant hospital's CJR 
beneficiaries during a CJR model episode that occurred during the same 
performance year for which the participant hospital accrued the internal 
cost savings or earned the reconciliation payment that comprises the 
distribution payment being distributed.

[[Page 936]]

    (9) The total amount of all downstream distribution payments made to 
downstream collaboration agents must not exceed the amount of the 
distribution payment received by the PGP, NPPGP, or TGP from the ACO.
    (10) All downstream distribution payments must be made by check, 
electronic funds transfer, or another traceable cash transaction.
    (11) The downstream collaboration agent must retain his or her 
ability to make decisions in the best interests of the patient, 
including the selection of devices, supplies, and treatments.
    (12) The downstream distribution arrangement must not--
    (i) Induce the downstream collaboration agent to reduce or limit 
medically necessary services to any Medicare beneficiary; or
    (ii) Reward the provision of items and services that are medically 
unnecessary.
    (13) The PGP, NPPGP, or TGP must maintain contemporaneous 
documentation regarding downstream distribution arrangements in 
accordance with Sec. 510.110, including the following:
    (i) The relevant written agreements.
    (ii) The date and amount of any downstream distribution payment.
    (iii) The identity of each downstream collaboration agent that 
received a downstream distribution payment.
    (iv) A description of the methodology and accounting formula for 
determining the amount of any downstream distribution payment.
    (14) The PGP, NPPGP, or TGP may not enter into a downstream 
distribution arrangement with any PGP member, NPPGP member, or TGP 
member who has--
    (i) A sharing arrangement with a participant hospital.
    (ii) A distribution arrangement with the ACO that the PGP, NPPGP, or 
TGP is a participant in.
    (15) The PGP, NPPGP, or TGP must retain and provide access to, and 
must require downstream collaboration agents to retain and provide 
access to, the required documentation in accordance with Sec. 510.110.

[82 FR 621, Jan. 3, 2017, as amended at 86 FR 23575, May 3, 2021]



Sec. 510.510  Enforcement authority.

    (a) OIG authority. OIG authority is not limited or restricted by the 
provisions of the CJR model, including the authority to audit, evaluate, 
investigate, or inspect the participant hospital, CJR collaborators, or 
any other person or entity or their records, data, or information, 
without limitation.
    (b) Other authorities. None of the provisions of the CJR model 
limits or restricts the authority of any other government agency 
permitted by law to audit, evaluate, investigate, or inspect the 
participant hospital, CJR collaborators, or any other person or entity 
or their records, data, or information, without limitation.



Sec. 510.515  Beneficiary incentives under the CJR model.

    (a) General. Participant hospitals may choose to provide in-kind 
patient engagement incentives to beneficiaries in a CJR episode, subject 
to the following conditions:
    (1) The incentive must be provided directly by the participant 
hospital or by an agent of the hospital under the hospital's direction 
and control to the beneficiary during a CJR episode of care.
    (2) The item or service provided must be reasonably connected to 
medical care provided to a beneficiary during a CJR episode of care.
    (3) The item or service must be a preventive care item or service or 
an item or service that advances a clinical goal, as listed in paragraph 
(c) of this section, for a beneficiary in a CJR episode by engaging the 
beneficiary in better managing his or her own health.
    (4) The item or service must not be tied to the receipt of items or 
services outside the CJR episode of care.
    (5) The item or service must not be tied to the receipt of items or 
services from a particular provider or supplier.
    (6) The availability of the items or services must not be advertised 
or promoted except that a beneficiary may be made aware of the 
availability of the items or services at the time the beneficiary could 
reasonably benefit from them.
    (7) The cost of the items or services must not be shifted to another 
federal

[[Page 937]]

health care program, as defined at section 1128B(f) of the Act.
    (b) Technology provided to a CJR beneficiary. Beneficiary engagement 
incentives involving technology are subject to the following additional 
conditions:
    (1) Items or services involving technology provided to a beneficiary 
may not exceed $1,000 in retail value for any one beneficiary in any one 
CJR episode.
    (2) Items or services involving technology provided to a beneficiary 
must be the minimum necessary to advance a clinical goal, as listed in 
paragraph (c) of this section, for a beneficiary in a CJR episode.
    (3) Items of technology exceeding $100 in retail value must--
    (i) Remain the property of the CJR participant; and
    (ii) Be retrieved from the beneficiary at the end of the CJR 
episode. The participant hospital must document all retrieval attempts, 
including the ultimate date of retrieval. Documented, diligent, good 
faith attempts to retrieve items of technology will be deemed to meet 
the retrieval requirement.
    (c) Clinical goals of the CJR model. The following are the clinical 
goals of the CJR model, which may be advanced through beneficiary 
incentives:
    (1) Beneficiary adherence to drug regimens.
    (2) Beneficiary adherence to a care plan.
    (3) Reduction of readmissions and complications resulting from LEJR 
procedures.
    (4) Management of chronic diseases and conditions that may be 
affected by the LEJR procedure.
    (d) Documentation of beneficiary incentives. (1) Participant 
hospitals must maintain documentation of items and services furnished as 
beneficiary incentives that exceed $25 in retail value.
    (2) The documentation must be established contemporaneously with the 
provision of the items and services and must include at least the 
following:
    (i) The date the incentive is provided.
    (ii) The identity of the beneficiary to whom the item or service was 
provided.
    (3) The documentation regarding items of technology exceeding $100 
in retail value must also include contemporaneous documentation of any 
attempt to retrieve technology at the end of a CJR episode as described 
in paragraph (b)(3) of this section.
    (4) The CJR participant hospital must retain and provide access to 
the required documentation in accordance with Sec. 510.110.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 621, Jan. 3, 2017]



                            Subpart G_Waivers



Sec. 510.600  Waiver of direct supervision requirement for certain 
post-discharge home visits.

    (a) General. CMS waives the requirement in Sec. 410.26(b)(5) of 
this chapter that services and supplies furnished incident to a 
physician's service must be furnished under the direct supervision of 
the physician (or other practitioner) to permit home visits as specified 
in this section. The services furnished under this waiver are not 
considered to be ``hospital services,'' even when furnished by the 
clinical staff of the hospital.
    (b) General supervision of qualified personnel. The waiver of the 
direct supervision requirement in Sec. 410.26(b)(5) of this chapter 
applies only in the following circumstances:
    (1) The home visit is furnished during the episode to a beneficiary 
who has been discharged from an anchor hospitalization or anchor 
procedure.
    (2) The home visit is furnished at the beneficiary's home or place 
of residence.
    (3) The beneficiary does not qualify for home health services under 
sections 1835(a) and 1814(a) of the Act at the time of any such home 
visit.
    (4) The visit is furnished by clinical staff under the general 
supervision of a physician or non-physician practitioner. Clinical staff 
are individuals who work under the supervision of a physician or other 
qualified health care professional, and who are allowed by law, 
regulation, and facility policy to perform or assist in the performance 
of a specific professional service, but do not individually report that 
professional service.
    (5) No more than 9 visits are furnished to the beneficiary during 
the episode.

[[Page 938]]

    (c) Payment. Up to 9 post-discharge home visits per CJR episode may 
be billed under Part B by the physician or nonphysician practitioner or 
by the participant hospital to which the supervising physician has 
reassigned his or her billing rights.
    (d) Other requirements. All other Medicare rules for coverage and 
payment of services incident to a physician's service continue to apply.

[80 FR 73540, Nov. 24, 2015, as amended at 86 FR 23575, May 3, 2021]



Sec. 510.605  Waiver of certain telehealth requirements.

    (a) Waiver of the geographic site requirements. Except for the 
geographic site requirements for a face-to-face encounter for home 
health certification, CMS waives the geographic site requirements of 
section 1834(m)(4)(C)(i)(I) through (III) of the Act for episodes being 
tested in the CJR model, but only for services that--
    (1) May be furnished via telehealth under existing requirements; and
    (2) Are included in the episode in accordance with Sec. 510.200(b).
    (b) Waiver of the originating site requirements. Except for the 
originating site requirements for a face-to-face encounter for home 
health certification, CMS waives the originating site requirements under 
section 1834(m)(4)(C)(ii)(I) through (VIII) of the Act for episodes 
being tested in the CJR model to permit a telehealth visit to originate 
in the beneficiary's home or place of residence, but only for services 
that--
    (1) May be furnished via telehealth under existing requirements; and
    (2) Are included in the CJR episode in accordance with Sec. 
510.200(b).
    (c) Waiver of selected payment provisions. (1) CMS waives the 
payment requirements under section 1834(m)(2)(A) so that the facility 
fee normally paid by Medicare to an originating site for a telehealth 
service is not paid if the service is originated in the beneficiary's 
home or place of residence.
    (2) CMS waives the payment requirements under section 1834(m)(2)(B) 
of the Act to allow the distant site payment for telehealth home visit 
HCPCS codes unique to this model.
    (d) Other requirements. All other requirements for Medicare coverage 
and payment of telehealth services continue to apply, including the list 
of specific services approved to be furnished by telehealth.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 57104, Dec. 1, 2017]



Sec. 510.610  Waiver of SNF 3-day rule.

    (a) Waiver of the SNF 3-day rule--(1) Performance year--(i) 
Performance years 2 through 5. For episodes being tested in performance 
years 2 through 5 of the CJR model, CMS waives the SNF 3-day rule for 
coverage of a SNF stay for a beneficiary who is a CJR beneficiary on the 
date of discharge from the anchor hospitalization, but only if the SNF 
is identified on the applicable calendar quarter list of qualified SNFs 
at the time of the CJR beneficiary's admission to the SNF.
    (ii) Performance years 6 through 8. (A) For episodes being tested in 
performance years 6 through 8 of the CJR model, CMS waives the SNF 3-day 
rule for coverage of a SNF stay within 30 days of the date of discharge 
from the anchor hospitalization for a beneficiary who is a CJR 
beneficiary on the date of discharge from the anchor hospitalization, 
but only if the SNF is identified on the applicable calendar quarter 
list of qualified SNFs at the time of the CJR beneficiary's admission to 
the SNF.
    (B) For episodes being tested in performance years 6 through 8 of 
the CJR model, CMS waives the SNF 3-day rule for coverage of a SNF stay 
within 30 days of the date of service of the anchor procedure for a 
beneficiary who is a CJR beneficiary on the date of service of the 
anchor procedure, but only if the SNF is identified on the applicable 
calendar quarter list of qualified SNFs at the time of the CJR 
beneficiary's admission to the SNF.
    (2) Determination of qualified SNFs. CMS determines the qualified 
SNFs for each calendar quarter based on a review of the most recent 
rolling 12 months of overall star ratings on the Five-Star Quality 
Rating System for SNFs on the Nursing Home Compare website. Qualified 
SNFs are rated an overall of 3 stars or better for at least 7 of the 12 
months.

[[Page 939]]

    (3) Posting of qualified SNFs. CMS posts to the CMS website the list 
of qualified SNFs in advance of the calendar quarter.
    (b) Financial liability for non-covered SNF services. If CMS 
determines that the waiver requirements specified in paragraph (a) of 
this section were not met, the following apply:
    (1) CMS makes no payment to a SNF for SNF services if the SNF admits 
a CJR beneficiary who has not had a qualifying inpatient stay or anchor 
procedure.
    (2) In the event that CMS makes no payment for SNF services 
furnished by a SNF as a result of paragraph (b)(1) of this section, the 
beneficiary protections specified in paragraph (b)(3) of this section 
apply, unless the participant hospital has provided the beneficiary with 
a discharge planning notice in accordance with Sec. 510.405(b)(3).
    (3) If the participant hospital does not provide the beneficiary 
with a discharge planning notice in accordance with Sec. 
510.405(b)(3)--
    (i) The SNF must not charge the beneficiary for the expenses 
incurred for such services;
    (ii) The SNF must return to the beneficiary any monies collected for 
such services; and
    (iii) The participant hospital is financially liable for the 
expenses incurred for such services.
    (4) If the participant hospital provided a discharge planning notice 
to the beneficiary in accordance with Sec. 510.405(b)(3), then normal 
SNF coverage requirements apply and the beneficiary may be financially 
liable for non-covered SNF services.
    (c) Other requirements. All other Medicare rules for coverage and 
payment of Part A-covered services continue to apply except as otherwise 
waived in this part.

[82 FR 622, Jan. 3, 2017, as amended at 86 FR 23575, May 3, 2021]



Sec. 510.615  Waiver of certain post-operative billing restrictions.

    (a) Waiver to permit certain services to be billed separately during 
the 90-day post-operative global surgical period. CMS waives the billing 
requirements for global surgeries to allow the separate billing of 
certain post-discharge home visits described under Sec. 510.600, 
including those related to recovery from the surgery, as described in 
paragraph (b) of this section, for episodes being tested in the CJR 
model.
    (b) Services to which the waiver applies. Up to 9 post-discharge 
home visits, including those related to recovery from the surgery, per 
CJR episode may be billed separately under Part B by the physician or 
nonphysician practitioner, or by the participant hospital to which the 
physician or nonphysician practitioner has reassigned his or her billing 
rights.
    (c) Other requirements. All other Medicare rules for global surgery 
billing during the 90-day post-operative period continue to apply.



Sec. 510.620  Waiver of deductible and coinsurance that otherwise 
apply to reconciliation payments or repayments.

    (a) Waiver of deductible and coinsurance. CMS waives the 
requirements of sections 1813 and 1833(a) of the Act for Medicare Part A 
and Part B payment systems only to the extent necessary to make 
reconciliation payments or receive repayments based on the NPRA that 
reflect the episode payment methodology under the final payment model 
for CJR participant hospitals.
    (b) Reconciliation payments or repayments. Reconciliation payments 
or repayments do not affect the beneficiary cost-sharing amounts for the 
Part A and Part B services provided under the CJR model.

[80 FR 73540, Nov. 24, 2015, as amended at 82 FR 622, Jan. 3, 2017]

Subparts H-J [Reserved]



                       Subpart K_Model Termination



Sec. 510.900  Termination of the CJR model.

    CMS may terminate the CJR model for reasons including but not 
limited to the following:
    (a) CMS determines that it no longer has the funds to support the 
CJR model.
    (b) CMS terminates the model in accordance with section 
1115A(b)(3)(B) of the Act. As provided by section 1115A(d)(2) of the 
Act, termination of

[[Page 940]]

the model is not subject to administrative or judicial review.



PART 512_RADIATION ONCOLOGY MODEL AND END STAGE RENAL DISEASE 
TREATMENT CHOICES MODEL--Table of Contents



    Subpart A_General Provisions Related to Innovation Center Models

Sec.
512.100 Basis and scope.
512.110 Definitions.
512.120 Beneficiary protections.
512.130 Cooperation in model evaluation and monitoring.
512.135 Audits and record retention.
512.140 Rights in data and intellectual property.
512.150 Monitoring and compliance.
512.160 Remedial action.
512.165 Innovation center model termination by CMS.
512.170 Limitations on review.
512.180 Miscellaneous provisions on bankruptcy and other notifications.

                   Subpart B_Radiation Oncology Model

                                 General

512.200 Basis and scope of subpart.
512.205 Definitions.

                         RO Model Participation

512.210 RO participants and geographic areas.
512.215 Beneficiary population.
512.217 Identification of individual practitioners.
512.220 RO participant compliance with RO Model requirements.
512.225 Beneficiary notification.

                    Scope of RO Episodes Being Tested

512.230 Criteria for determining cancer types.
512.235 Included RT services.
512.240 Included modalities.
512.245 Included RO episodes.

                           Pricing Methodology

512.250 Determination of national base rates.
512.255 Determination of participant-specific professional episode 
          payment and participant-specific technical episode payment 
          amounts.

                           Billing and Payment

512.260 Billing.
512.265 Payment.
512.270 Treatment of add-on payments under existing Medicare payment 
          systems.

                             Data Reporting

512.275 Quality measures, clinical data, and reporting.

                        Medicare Program Waivers

512.280 RO Model Medicare program waivers.

                    Reconciliation and Review Process

512.285 Reconciliation process.
512.290 Timely error notice and reconsideration review process.

                 Subpart C_ESRD Treatment Choices Model

                                 General

512.300 Basis and scope.
512.310 Definitions.

           ESRD Treatment Choices Model Scope and Participants

512.320 Duration.
512.325 Participant selection and geographic areas.
512.330 Beneficiary notification.

                    Home Dialysis Payment Adjustment

512.340 Payments subject to the facility HDPA.
512.345 Payments subject to the clinician HDPA.
512.350 Schedule of home dialysis payment adjustments.

                     Performance Payment Adjustment

512.355 Schedule of performance assessment and performance payment 
          adjustment.
512.360 Beneficiary population and attribution.
512.365 Performance assessment.
512.370 Benchmarking and scoring.
512.375 Payments subject to adjustment.
512.380 PPA amounts and schedule.
512.385 PPA exclusions.
512.390 Notification and targeted review.

                           Quality Monitoring

512.395 Quality measures.

                        Medicare Program Waivers

512.397 ETC Model Medicare program waivers.

    Authority: 42 U.S.C. 1302, 1315a, and 1395hh.

    Source: 85 FR 61362, Sept. 29, 2020, unless otherwise noted.

[[Page 941]]



    Subpart A_General Provisions Related to Innovation Center Models



Sec. 512.100  Basis and scope.

    (a) Basis. This subpart implements certain general provisions for 
the Radiation Oncology Model implemented under subpart B (RO Model) and 
the End-Stage Renal Disease (ESRD) Treatment Choices Model implemented 
under subpart C (ETC Model), collectively referred to in this subpart as 
Innovation Center models. Except as specifically noted in this part, the 
regulations do not affect the applicability of other provisions 
affecting providers and suppliers under Medicare Fee-For-Service (FFS), 
including provisions regarding payment, coverage, or program integrity.
    (b) Scope. The regulations in this subpart apply to model 
participants in the RO Model (except as otherwise noted in Sec. 
512.160(b)(6)) and to model participants in the ETC Model. This subpart 
sets forth the following:
    (1) Basis and scope.
    (2) Beneficiary protections.
    (3) Model participant requirements for participation in model 
evaluation and monitoring, and record retention.
    (4) Rights in data and intellectual property.
    (5) Monitoring and compliance.
    (6) Remedial action and termination by CMS.
    (7) Limitations on review.
    (8) Miscellaneous provisions on bankruptcy and notification.



Sec. 512.110  Definitions.

    For purposes of this part, the following terms are defined as 
follows unless otherwise stated:
    Beneficiary means an individual who is enrolled in Medicare FFS.
    Change in control means any of the following:
    (1) The acquisition by any ``person'' (as this term is used in 
sections 13(d) and 14(d) of the Securities Exchange Act of 1934) of 
beneficial ownership (within the meaning of Rule 13d-3 promulgated under 
the Securities Exchange Act of 1934), directly or indirectly, of voting 
securities of the model participant representing more than 50 percent of 
the model participant's outstanding voting securities or rights to 
acquire such securities.
    (2) The acquisition of the model participant by any individual or 
entity.
    (3) The sale, lease, exchange or other transfer (in one transaction 
or a series of transactions) of all or substantially all of the assets 
of the model participant.
    (4) The approval and completion of a plan of liquidation of the 
model participant, or an agreement for the sale or liquidation of the 
model participant.
    Covered services means the scope of health care benefits described 
in sections 1812 and 1832 of the Act for which payment is available 
under Part A or Part B of Title XVIII of the Act.
    Days means calendar days.
    Descriptive model materials and activities means general audience 
materials such as brochures, advertisements, outreach events, letters to 
beneficiaries, web pages, mailings, social media, or other materials or 
activities distributed or conducted by or on behalf of the model 
participant or its downstream participants when used to educate, notify, 
or contact beneficiaries regarding the Innovation Center model. The 
following communications are not descriptive model materials and 
activities: Communications that do not directly or indirectly reference 
the Innovation Center model (for example, information about care 
coordination generally); information on specific medical conditions; 
referrals for health care items and services; and any other materials 
that are excepted from the definition of ``marketing'' as that term is 
defined at 45 CFR 164.501.
    Downstream participant means an individual or entity that has 
entered into a written arrangement with a model participant under which 
the downstream participant engages in one or more Innovation Center 
model activities.
    Innovation Center model means the RO Model implemented under subpart 
B or the ETC Model implemented under subpart C.
    Innovation Center model activities means any activities impacting 
the care of model beneficiaries related to the test of the Innovation 
Center model under the terms of this part.

[[Page 942]]

    Medically necessary means reasonable and necessary for the diagnosis 
or treatment of an illness or injury, or to improve the functioning of a 
malformed body member.
    Model beneficiary means a beneficiary attributed to a model 
participant or otherwise included in an Innovation Center model under 
the terms of this part.
    Model participant means an individual or entity that is identified 
as a participant in the Innovation Center model under the terms of this 
part.
    Model-specific payment means a payment made by CMS only to model 
participants, or a payment adjustment made only to payments made to 
model participants, under the terms of the Innovation Center model that 
is not applicable to any other providers or suppliers.
    Provider means a ``provider of services'' as defined under section 
1861(u) of the Act and codified in the definition of ``provider'' at 
Sec. 400.202 of this chapter.
    Supplier means a supplier as defined in section 1861(d) of the Act 
and codified at Sec. 400.202 of this chapter.
    U.S. Territories means American Samoa, the Federated States of 
Micronesia, Guam, the Marshall Islands, and the Commonwealth of the 
Northern Mariana Islands, Palau, Puerto Rico, U.S. Minor Outlying 
Islands, and the U.S. Virgin Islands.



Sec. 512.120  Beneficiary protections.

    (a) Beneficiary freedom of choice. (1) The model participant and its 
downstream model participants must not restrict beneficiaries' ability 
to choose to receive care from any provider or supplier.
    (2) The model participant and its downstream model participants must 
not commit any act or omission, nor adopt any policy that inhibits 
beneficiaries from exercising their freedom to choose to receive care 
from any provider or supplier or from any health care provider who has 
opted out of Medicare. The model participant and its downstream model 
participants may communicate to model beneficiaries the benefits of 
receiving care with the model participant, if otherwise consistent with 
the requirements of this part and applicable law.
    (b) Availability of services. (1) The model participant and its 
downstream participants must continue to make medically necessary 
covered services available to beneficiaries to the extent required by 
applicable law. Model beneficiaries and their assignees retain their 
rights to appeal claims in accordance with part 405, subpart I of this 
chapter.
    (2) The model participant and its downstream participants must not 
take any action to select or avoid treating certain Medicare 
beneficiaries based on their income levels or based on factors that 
would render the beneficiary an ``at-risk beneficiary'' as defined at 
Sec. 425.20 of this chapter.
    (3) The model participant and its downstream participants must not 
take any action to selectively target or engage beneficiaries who are 
relatively healthy or otherwise expected to improve the model 
participant's or downstream participant's financial or quality 
performance, a practice commonly referred to as ``cherry-picking.''
    (c) Descriptive model materials and activities. (1) The model 
participant and its downstream participants must not use or distribute 
descriptive model materials and activities that are materially 
inaccurate or misleading.
    (2) The model participant and its downstream participants must 
include the following statement on all descriptive model materials and 
activities: ``The statements contained in this document are solely those 
of the authors and do not necessarily reflect the views or policies of 
the Centers for Medicare & Medicaid Services (CMS). The authors assume 
responsibility for the accuracy and completeness of the information 
contained in this document.''
    (3) The model participant and its downstream participants must 
retain copies of all written and electronic descriptive model materials 
and activities and appropriate records for all other descriptive model 
materials and activities in a manner consistent with Sec. 512.135(c).
    (4) CMS reserves the right to review, or have a designee review, 
descriptive model materials and activities to determine whether or not 
the content is materially inaccurate or misleading. This review takes 
place at a time and

[[Page 943]]

in a manner specified by CMS once the descriptive model materials and 
activities are in use by the model participant.



Sec. 512.130  Cooperation in model evaluation and monitoring.

    The model participant and its downstream participants must comply 
with the requirements of Sec. 403.1110(b) of this chapter and must 
otherwise cooperate with CMS' model evaluation and monitoring activities 
as may be necessary to enable CMS to evaluate the Innovation Center 
model in accordance with section 1115A(b)(4) of the Act and to conduct 
monitoring activities under Sec. 512.150, including producing such data 
as may be required by CMS to evaluate or monitor the Innovation Center 
model, which may include protected health information as defined in 45 
CFR 160.103 and other individually-identifiable data.



Sec. 512.135  Audits and record retention.

    (a) Right to audit. The Federal government, including CMS, HHS, and 
the Comptroller General, or their designees, has the right to audit, 
inspect, investigate, and evaluate any documents and other evidence 
regarding implementation of an Innovation Center model.
    (b) Access to records. The model participant and its downstream 
participants must maintain and give the Federal government, including 
CMS, HHS, and the Comptroller General, or their designees, access to all 
such documents and other evidence sufficient to enable the audit, 
evaluation, inspection, or investigation of the implementation of the 
Innovation Center model, including without limitation, documents and 
other evidence regarding all of the following:
    (1) The model participant's and its downstream participants' 
compliance with the terms of the Innovation Center model, including this 
subpart.
    (2) The accuracy of model-specific payments made under the 
Innovation Center model.
    (3) The model participant's payment of amounts owed to CMS under the 
Innovation Center model.
    (4) Quality measure information and the quality of services 
performed under the terms of the Innovation Center model, including this 
subpart.
    (5) Utilization of items and services furnished under the Innovation 
Center model.
    (6) The ability of the model participant to bear the risk of 
potential losses and to repay any losses to CMS, as applicable.
    (7) Patient safety.
    (8) Other program integrity issues.
    (c) Record retention. (1) The model participant and its downstream 
participants must maintain the documents and other evidence described in 
paragraph (b) of this section and other evidence for a period of six 
years from the last payment determination for the model participant 
under the Innovation Center model or from the date of completion of any 
audit, evaluation, inspection, or investigation, whichever is later, 
unless--
    (i) CMS determines there is a special need to retain a particular 
record or group of records for a longer period and notifies the model 
participant at least 30 days before the normal disposition date; or
    (ii) There has been a termination, dispute, or allegation of fraud 
or similar fault against the model participant or its downstream 
participants, in which case the records must be maintained for an 
additional 6 years from the date of any resulting final resolution of 
the termination, dispute, or allegation of fraud or similar fault.
    (2) If CMS notifies the model participant of the special need to 
retain records in accordance with paragraph (c)(1)(i) of this section or 
there has been a termination, dispute, or allegation of fraud or similar 
fault against the model participant or its downstream participants 
described in paragraph (c)(1)(ii) of this section, the model participant 
must notify its downstream participants of this need to retain records 
for the additional period specified by CMS.



Sec. 512.140  Rights in data and intellectual property.

    (a) CMS may--
    (1) Use any data obtained under Sec. Sec. 512.130, 512.135, and 
512.150 to evaluate and monitor the Innovation Center model; and

[[Page 944]]

    (2) Disseminate quantitative and qualitative results and successful 
care management techniques, including factors associated with 
performance, to other providers and suppliers and to the public. Data 
disseminated may include patient--
    (i) De-identified results of patient experience of care and quality 
of life surveys, and
    (ii) De-identified measure results calculated based upon claims, 
medical records, and other data sources.
    (b) Notwithstanding any other provision of this part, for all data 
that CMS confirms to be proprietary trade secret information and 
technology of the model participant or its downstream participants, CMS 
or its designee(s) will not release this data without the express 
written consent of the model participant or its downstream participant, 
unless such release is required by law.
    (c) If the model participant or its downstream participant wishes to 
protect any proprietary or confidential information that it submits to 
CMS or its designee, the model participant or its downstream participant 
must label or otherwise identify the information as proprietary or 
confidential. Such assertions are subject to review and confirmation by 
CMS prior to CMS' acting upon such assertions.



Sec. 512.150  Monitoring and compliance.

    (a) Compliance with laws. The model participant and each of its 
downstream participants must comply with all applicable laws and 
regulations.
    (b) CMS monitoring and compliance activities. (1) CMS may conduct 
monitoring activities to ensure compliance by the model participant and 
each of its downstream participants with the terms of the Innovation 
Center model including this subpart; to understand model participants' 
use of model-specific payments; and to promote the safety of 
beneficiaries and the integrity of the Innovation Center model. Such 
monitoring activities may include, without limitation, all of the 
following:
    (i) Documentation requests sent to the model participant and its 
downstream participants, including surveys and questionnaires.
    (ii) Audits of claims data, quality measures, medical records, and 
other data from the model participant and its downstream participants.
    (iii) Interviews with members of the staff and leadership of the 
model participant and its downstream participants.
    (iv) Interviews with beneficiaries and their caregivers.
    (v) Site visits to the model participant and its downstream 
participants, performed in a manner consistent with paragraph (c) of 
this section.
    (vi) Monitoring quality outcomes and clinical data, if applicable.
    (vii) Tracking patient complaints and appeals.
    (2) In conducting monitoring and oversight activities, CMS or its 
designees may use any relevant data or information including without 
limitation all Medicare claims submitted for items or services furnished 
to model beneficiaries.
    (c) Site visits. (1) In a manner consistent with Sec. 512.130, the 
model participant and its downstream participants must cooperate in 
periodic site visits performed by CMS or its designees in order to 
facilitate the evaluation of the Innovation Center model and the 
monitoring of the model participant's compliance with the terms of the 
Innovation Center model, including this subpart.
    (2) CMS or its designee provides, to the extent practicable, the 
model participant or downstream participant with no less than 15 days 
advance notice of any site visit. CMS--
    (i) Will attempt, to the extent practicable, to accommodate a 
request for particular dates in scheduling site visits.
    (ii) Will not accept a date request from a model participant or 
downstream participant that is more than 60 days after the date of the 
CMS initial site visit notice.
    (3) The model participant and its downstream participants must 
ensure that personnel with the appropriate responsibilities and 
knowledge associated with the purpose of the site visit are available 
during all site visits.
    (4) Additionally, CMS may perform unannounced site visits at the 
office of the model participant and any of its

[[Page 945]]

downstream participants at any time to investigate concerns about the 
health or safety of beneficiaries or other patients or other program 
integrity issues.
    (5) Nothing in this part shall be construed to limit or otherwise 
prevent CMS from performing site visits permitted or required by 
applicable law.
    (d) Reopening of payment determinations. (1) CMS may reopen a model-
specific payment determination on its own motion or at the request of a 
model participant, within 4 years from the date of the determination, 
for good cause (as defined at Sec. 405.986 of this chapter).
    (2) CMS may reopen a model-specific payment determination at any 
time if there exists reliable evidence (as defined in Sec. 405.902 of 
this chapter) that the determination was procured by fraud or similar 
fault (as defined in Sec. 405.902 of this chapter).
    (3) CMS's decision regarding whether to reopen a model-specific 
payment determination is binding and not subject to appeal.
    (e) OIG authority. Nothing contained in the terms of the Innovation 
Center Model or this part limits or restricts the authority of the HHS 
Office of Inspector General or any other Federal government authority, 
including its authority to audit, evaluate, investigate, or inspect the 
model participant or its downstream participants for violations of any 
Federal statutes, rules, or regulations.



Sec. 512.160  Remedial action.

    (a) Grounds for remedial action. CMS may take one or more remedial 
actions described in paragraph (b) of this section if CMS determines 
that the model participant or a downstream participant:
    (1) Has failed to comply with any of the terms of the Innovation 
Center Model, including this subpart.
    (2) Has failed to comply with any applicable Medicare program 
requirement, rule, or regulation.
    (3) Has taken any action that threatens the health or safety of a 
beneficiary or other patient.
    (4) Has submitted false data or made false representations, 
warranties, or certifications in connection with any aspect of the 
Innovation Center model.
    (5) Has undergone a change in control that presents a program 
integrity risk.
    (6) Is subject to any sanctions of an accrediting organization or a 
Federal, State, or local government agency.
    (7) Is subject to investigation or action by HHS (including the HHS 
Office of Inspector General and CMS) or the Department of Justice due to 
an allegation of fraud or significant misconduct, including being 
subject to the filing of a complaint or filing of a criminal charge, 
being subject to an indictment, being named as a defendant in a False 
Claims Act qui tam matter in which the Federal government has 
intervened, or similar action.
    (8) Has failed to demonstrate improved performance following any 
remedial action imposed under this section.
    (b) Remedial actions. If CMS determines that one or more grounds for 
remedial action described in paragraph (a) of this section has taken 
place, CMS may take one or more of the following remedial actions:
    (1) Notify the model participant and, if appropriate, require the 
model participant to notify its downstream participants of the 
violation.
    (2) Require the model participant to provide additional information 
to CMS or its designees.
    (3) Subject the model participant to additional monitoring, 
auditing, or both.
    (4) Prohibit the model participant from distributing model-specific 
payments, as applicable.
    (5) Require the model participant to terminate, immediately or by a 
deadline specified by CMS, its agreement with a downstream participant 
with respect to the Innovation Center model.
    (6) In the ETC Model only, terminate the ETC Participant from the 
ETC Model.
    (7) Require the model participant to submit a corrective action plan 
in a form and manner and by a deadline specified by CMS.
    (8) Discontinue the provision of data sharing and reports to the 
model participant.
    (9) Recoup model-specific payments.

[[Page 946]]

    (10) Reduce or eliminate a model-specific payment otherwise owed to 
the model participant.
    (11) Such other action as may be permitted under the terms of this 
part.



Sec. 512.165  Innovation center model termination by CMS.

    (a) CMS may terminate an Innovation Center model for reasons 
including, but not limited to, the following:
    (1) CMS determines that it no longer has the funds to support the 
Innovation Center model.
    (2) CMS terminates the Innovation Center model in accordance with 
section 1115A(b)(3)(B) of the Act.
    (b) If CMS terminates an Innovation Center model, CMS provides 
written notice to the model participant specifying the grounds for model 
termination and the effective date of such termination.



Sec. 512.170  Limitations on review.

    There is no administrative or judicial review under sections 1869 or 
1878 of the Act or otherwise for all of the following:
    (a) The selection of models for testing or expansion under section 
1115A of the Act.
    (b) The selection of organizations, sites, or participants, 
including model participants, to test the Innovation Center models 
selected, including a decision by CMS to remove a model participant or 
to require a model participant to remove a downstream participant from 
the Innovation Center model.
    (c) The elements, parameters, scope, and duration of such Innovation 
Center models for testing or dissemination, including without limitation 
the following:
    (1) The selection of quality performance standards for the 
Innovation Center model by CMS.
    (2) The methodology used by CMS to assess the quality of care 
furnished by the model participant.
    (3) The methodology used by CMS to attribute model beneficiaries to 
the model participant, if applicable.
    (d) Determinations regarding budget neutrality under section 
1115A(b)(3) of the Act.
    (e) The termination or modification of the design and implementation 
of an Innovation Center model under section 1115A(b)(3)(B) of the Act.
    (f) Determinations about expansion of the duration and scope of an 
Innovation Center model under section 1115A(c) of the Act, including the 
determination that an Innovation Center model is not expected to meet 
criteria described in paragraph (a) or (b) of such section.



Sec. 512.180  Miscellaneous provisions on bankruptcy and other 
notifications.

    (a) Notice of bankruptcy. If the model participant has filed a 
bankruptcy petition, whether voluntary or involuntary, the model 
participant must provide written notice of the bankruptcy to CMS and to 
the U.S. Attorney's Office in the district where the bankruptcy was 
filed, unless final payment has been made by either CMS or the model 
participant under the terms of each model tested under section 1115A of 
the Act in which the model participant is participating or has 
participated and all administrative or judicial review proceedings 
relating to any payments under such models have been fully and finally 
resolved. The notice of bankruptcy must be sent by certified mail no 
later than 5 days after the petition has been filed and must contain a 
copy of the filed bankruptcy petition (including its docket number), and 
a list of all models tested under section 1115A of the Act in which the 
model participant is participating or has participated. This list need 
not identify a model tested under section 1115A of the Act in which the 
model participant participated if final payment has been made under the 
terms of the model and all administrative or judicial review proceedings 
regarding model-specific payments between the model participant and CMS 
have been fully and finally resolved with respect to that model. The 
notice to CMS must be addressed to the CMS Office of Financial 
Management at 7500 Security Boulevard, Mailstop C3-01-24, Baltimore, MD 
21244 or such other address as may be specified on the CMS website for 
purposes of receiving such notices.
    (b) Notice of legal name change. A model participant must furnish 
written

[[Page 947]]

notice to CMS at least 30 days after any change in its legal name 
becomes effective. The notice of legal name change must be in a form and 
manner specified by CMS and must include a copy of the legal document 
effecting the name change, which must be authenticated by the 
appropriate State official.
    (c) Notice of change in control. (1) A model participant must 
furnish written notice to CMS in a form and manner specified by CMS at 
least 90 days before any change in control becomes effective.
    (2)(i) If CMS determines, in accordance with Sec. 512.160(a)(5), 
that a model participant's change in control would present a program 
integrity risk, CMS may take remedial action against the model 
participant under Sec. 512.160(b).
    (ii) CMS may also require immediate reconciliation and payment of 
all monies owed to CMS by a model participant that is subject to a 
change in control.



                   Subpart B_Radiation Oncology Model

                                 General



Sec. 512.200  Basis and scope of subpart.

    (a) Basis. This subpart implements the test of the Radiation 
Oncology (RO) Model under section 1115A(b) of the Act. Except as 
specifically noted in this subpart, the regulations under this subpart 
do not affect the applicability of other regulations affecting providers 
and suppliers under Medicare FFS, including the applicability of 
regulations regarding payment, coverage, and program integrity.
    (b) Scope. This subpart sets forth the following:
    (1) RO Model participation.
    (2) Episodes being tested under the RO Model.
    (3) Methodology for pricing.
    (4) Billing and payment under the RO Model.
    (5) Data reporting requirements.
    (6) Medicare program waivers.
    (7) Payment reconciliation and review processes.
    (c) RO participants are subject to the general provisions for 
Innovation Center models specified in subpart A of this part 512 and in 
subpart K of part 403 of this chapter.



Sec. 512.205  Definitions.

    For purposes of this subpart, the following definitions apply:
    Aggregate quality score (AQS) means the numeric score calculated for 
each RO participant based on its performance on, and reporting of, 
quality measures and clinical data. The AQS is used to determine an RO 
participant's quality reconciliation payment amount.
    APM means Alternative Payment Model.
    ASC means Ambulatory Surgery Center.
    Blend means the weight given to an RO participant's historical 
experience adjustment relative to the geographically-adjusted trended 
national base rate in the calculation of its participant-specific 
episode payment amounts.
    CAH means Critical Access Hospital.
    CEHRT means Certified Electronic Health Record Technology.
    Clean period means the 28-day period after an RO episode has ended, 
during which time an RO participant must bill for medically necessary RT 
services furnished to the RO beneficiary in accordance with Medicare FFS 
billing rules.
    Core-Based Statistical Area (CBSA) means a statistical geographic 
area, based on the definition as identified by the Office of Management 
and Budget, with a population of at least 10,000, which consists of a 
county or counties anchored by at least one core (urbanized area or 
urban cluster), plus adjacent counties having a high degree of social 
and economic integration with the core (as measured through commuting 
ties with the counties containing the core).
    Discount factor means the set percentage by which CMS reduces 
payment of the professional component and technical component.
    (1) The reduction on payment occurs after the trend factor, the 
geographic adjustment, and the RO Model-specific adjustments have been 
applied but before beneficiary cost-sharing and standard CMS 
adjustments, including sequestration, have been applied.

[[Page 948]]

    (2) The discount factor does not vary by cancer type.
    (3) The discount factor for the professional component is 3.75 
percent; the discount factor for the technical component is 4.75 
percent.
    Dual participant means an RO participant that furnishes both the 
professional component and technical component of RT services of an RO 
episode through a freestanding radiation therapy center, identified by a 
single TIN.
    Duplicate RT service means any included RT service that is furnished 
to an RO beneficiary by an RT provider or RT supplier that is not 
excluded from participation in the RO Model at Sec. 512.210(b), and 
that did not initiate the PC or TC of the RO beneficiary's RO episode. 
Such services are furnished in addition to the RT services furnished by 
the RO participant that initiated the PC or TC and continues to furnish 
care to the RO beneficiary during the RO episode.
    Episode means the 90-day period of RT services that begins on the 
date of service that an RT provider or RT supplier that is not an RO 
participant furnishes an initial treatment planning service to a 
beneficiary, provided that an RT provider or RT supplier furnishes a 
technical component RT service to the beneficiary within 28 days of such 
initial treatment planning service. Additional criteria for constructing 
episodes to be included in determining the national base rates are set 
forth in Sec. 512.250.
    EOE stands for ``end of episode'' and means the end of an RO 
episode.
    HCPCS means Healthcare Common Procedure Coding System.
    HOPD means hospital outpatient department.
    Included cancer types means the cancer types determined by the 
criteria set forth in Sec. 512.230, which are included in the RO Model 
test.
    Included RT services means the RT services identified at Sec. 
512.235, which are included in the RO Model test.
    Incomplete episode means an RO episode that is deemed not to have 
occurred because:
    (1) A Technical participant or a Dual participant does not furnish a 
technical component to an RO beneficiary within 28 days following a 
Professional participant or the Dual participant furnishing an initial 
treatment planning service to that RO beneficiary;
    (2) An RO beneficiary ceases to have traditional FFS Medicare as his 
or her primary payer at any time after the initial treatment planning 
service is furnished and before the date of service on a claim with an 
RO Model-specific HCPCS code and an EOE modifier; or
    (3) An RO beneficiary switches RT provider or RT supplier before all 
included RT services in the RO episode have been furnished.
    Individual practitioner means a Medicare-enrolled physician 
(identified by an NPI) who furnishes RT services to Medicare FFS 
beneficiaries, and has reassigned his or her billing rights to the TIN 
of an RO participant.
    Individual practitioner list means a list of individual 
practitioners who furnish RT services under the TIN of a Dual 
participant or a Professional participant, which is annually compiled by 
CMS and which the RO participant must review, revise, and certify in 
accordance with Sec. 512.217. The individual practitioner list is used 
for the RO Model as a Participation List as defined in Sec. 414.1305 of 
this chapter.
    Initial reconciliation means the first reconciliation of a PY that 
occurs as early as August following the applicable PY.
    MIPS means Merit based Incentive Payment System.
    Model performance period means July 1, 2021, through December 31, 
2025, the last date on which an RO episode may end under the RO Model. 
No new RO episodes may begin after October 3, 2025, in order for all RO 
episodes to end by December 31, 2025.
    National base rate means the total payment amount for the relevant 
component of an RO episode, before application of the trend factor, 
discount factor, adjustments, and applicable withholds, for each of the 
included cancer types.
    NPI means National Provider Identifier.
    OPPS means outpatient prospective payment system.
    Participant-specific professional episode payment means a payment 
which is calculated by CMS as set forth in Sec. 512.255

[[Page 949]]

and which is paid by CMS to a Professional participant or Dual 
participant as set forth in Sec. 512.265, for the provision of the 
professional component to an RO beneficiary during an RO episode.
    Participant-specific technical episode payment means a payment which 
is calculated by CMS as set forth in Sec. 512.255 and which is paid by 
CMS to a Technical participant or Dual participant in accordance with 
Sec. 512.265, for the provision of the technical component to an RO 
beneficiary during an RO episode.
    Performance year (PY) means the 6-month period beginning on July 1, 
2021, and ending on December 31, 2021, and the 12-month period beginning 
on January 1 and ending on December 31 of each subsequent year (2022 
through 2025) during the Model performance period.
    PGP means physician group practice.
    PPS means prospective payment system.
    Professional component (PC) means the included RT services that may 
only be furnished by a physician.
    Professional participant means an RO participant that is a Medicare-
enrolled PGP identified by a single TIN that furnishes only the PC of an 
RO episode.
    PSO means patient safety organization.
    PY means performance year.
    QP means Qualifying APM Participants.
    Reconciliation payment means a payment made by CMS to an RO 
participant, as determined in accordance with Sec. 512.285.
    Repayment amount means the amount owed by an RO participant to CMS, 
as determined in accordance with Sec. 512.285.
    Reconciliation report means the annual report issued by CMS to an RO 
participant for each PY, which specifies the RO participant's 
reconciliation payment amount or repayment amount.
    RO beneficiary means a Medicare beneficiary who meets all of the 
beneficiary inclusion criteria at Sec. 512.215(a) and whose RO episode 
meets all the criteria defined at Sec. 512.245.
    RO episode means the 90-day period that, as set forth in Sec. 
512.245, begins on the date of service that a Professional participant 
or a Dual participant furnishes an initial treatment planning service to 
an RO beneficiary in a freestanding radiation therapy center or an HOPD, 
provided that a Technical participant or the same Dual participant 
furnishes a technical component RT service to the RO beneficiary within 
28 days of such RT treatment planning service.
    RO participant means a Medicare-enrolled PGP, freestanding radiation 
therapy center, or HOPD that participates in the RO Model in accordance 
with Sec. 512.210. An RO participant may be a Dual participant, 
Professional participant, or Technical participant.
    RT provider means a Medicare-enrolled HOPD that furnishes RT 
services.
    RT services are the treatment planning, technical preparation, 
special services (such as simulation), treatment delivery, and treatment 
management services associated with cancer treatment that uses high 
doses of radiation to kill cancer cells and shrink tumors.
    RT supplier means a Medicare-enrolled PGP or freestanding radiation 
therapy center that furnishes RT services.
    SOE stands for ``start of episode'' and means the start of an RO 
episode.
    Stop-loss limit means the set percentage at which loss is limited 
under the Model used to calculate the stop-loss reconciliation amount.
    Stop-loss reconciliation amount means the amount owed to RO 
participants that have fewer than 60 episodes during 2016-2018 and that 
were furnishing included RT services on November 30, 2020 in the CBSAs 
selected for participation for the loss incurred under the Model as 
described in Sec. 512.285(f).
    Technical component (TC) means the included RT services that are not 
furnished by a physician, including the provision of equipment, 
supplies, personnel, and administrative costs related to RT services.
    Technical participant means an RO participant that is a Medicare-
enrolled HOPD or freestanding radiation therapy center, identified by a 
single CMS Certification Number (CCN) or TIN, which furnishes only the 
TC of an RO episode.

[[Page 950]]

    TIN means Taxpayer Identification Number.
    Trend factor means an adjustment applied to the national base rates 
that updates those rates to reflect current trends in the OPPS and PFS 
rates for RT services.
    True-up reconciliation means the process to calculate additional 
reconciliation payments or repayment amounts for incomplete episodes and 
duplicate RT services that are identified after the initial 
reconciliation and after a 12-month claims run-out for all RO episodes 
initiated in the applicable PY.

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86304, Dec. 29, 2020]

    Editorial Note: At 85 FR 86304, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.

                         RO Model Participation



Sec. 512.210  RO participants and geographic areas.

    (a) RO participants. Unless otherwise specified in paragraph (b) or 
(c) of this section, any RO participant that furnishes included RT 
services in a 5-digit ZIP Code linked to a CBSA selected for 
participation to an RO beneficiary for an RO episode that begins on or 
after July 1, 2021, and ends on or before December 31, 2025, must 
participate in the RO Model.
    (b) Participant exclusions. A PGP, freestanding radiation therapy 
center, or HOPD is excluded from participation in the RO Model if it:
    (1) Furnishes RT services only in Maryland;
    (2) Furnishes RT services only in Vermont;
    (3) Furnishes RT services only in U.S. Territories;
    (4) Is classified as an ambulatory surgery center (ASC), critical 
access hospital (CAH), or Prospective Payment System (PPS)-exempt cancer 
hospital; or
    (5) Participates in or is identified by CMS as eligible to 
participate in the Pennsylvania Rural Health Model.
    (c) Low volume opt-out. A PGP, freestanding radiation therapy 
center, or HOPD, which would otherwise be required to participate in the 
RO Model may choose to opt-out of the RO Model for a given PY if it has 
fewer than 20 episodes of RT services across all CBSAs selected for 
participation in the most recent year with claims data available prior 
to the applicable PY. At least 30 days prior to the start of each PY, 
CMS notifies RO participants eligible for the low volume opt-out for the 
upcoming PY. The RO participant must attest to its intention of opting 
out of the RO Model prior to the start of the upcoming PY. Low volume 
opt-out eligibility is determined as follows:
    (1) PY1. Episodes from January 1, 2019 through December 31, 2019 
determine eligibility for the low volume opt-out for PY1.
    (2) PY2. Episodes from January 1, 2020 through December 31, 2020 
determine eligibility for the low volume opt-out for PY2.
    (3) PY3. Episodes from January 1, 2021 through June 30, 2021 and RO 
episodes from July 1, 2021 through December 31, 2021 determine 
eligibility for the low volume opt-out for PY3.
    (4) PY4. RO episodes from January 1, 2022 through December 31, 2022 
determine low volume opt-out eligibility for PY4.
    (5) PY5. RO episodes from January 1, 2023 through December 31, 2023 
determine low volume opt-out eligibility for PY5.
    (d) Selected CBSAs. CMS randomly selects CBSAs to identify RT 
providers and RT suppliers to participate in the RO Model through a 
stratified sample design, allowing for participant and comparison groups 
to contain approximately 30 percent of all episodes in eligible 
geographic areas (CBSAs).

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86304, Dec. 29, 2020]

    Editorial Note: At 85 FR 86304, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.



Sec. 512.215  Beneficiary population.

    (a) Beneficiary inclusion criteria. An individual is an RO 
beneficiary if:
    (1) The individual receives included RT services from an RO 
participant that billed the SOE modifier for the PC or TC of an RO 
episode during the

[[Page 951]]

Model performance period for an included cancer type; and
    (2) At the time that the initial treatment planning service of an RO 
episode is furnished by an RO participant, the individual:
    (i) Is eligible for Medicare Part A and enrolled in Medicare Part B;
    (ii) Has traditional FFS Medicare as his or her primary payer (for 
example, is not enrolled in a PACE plan, Medicare Advantage or another 
managed care plan, or United Mine Workers insurance); and
    (iii) Is not in a Medicare hospice benefit period.
    (b) Any individual enrolled in a clinical trial for RT services for 
which Medicare pays routine costs is an RO beneficiary if the individual 
satisfies all of the beneficiary inclusion criteria in paragraph (a) of 
this section.



Sec. 512.217  Identification of individual practitioners.

    (a) General. Upon the start of each PY, CMS creates and provides to 
each Dual participant and Professional participant an individual 
practitioner list identifying by NPI each individual practitioner 
associated with the RO participant.
    (b) Review of individual practitioner list. Within 30 days of 
receipt of the individual practitioner list, the RO participant must 
review and certify the individual practitioner list, correct any 
inaccuracies in accordance with paragraph (d) of this section, and 
certify the list (as corrected, if applicable) in a form and manner 
specified by CMS and in accordance with paragraph (c) of this section or 
correct the individual practitioner list in accordance with paragraph 
(d) of this section.
    (c) List certification. (1) Within 30 days of receipt of the 
individual practitioner list, and at such other times as specified by 
CMS, an individual with the authority to legally bind the RO participant 
must certify the accuracy, completeness, and truthfulness of the 
individual practitioner list to the best of his or her knowledge, 
information, and belief.
    (2) All Medicare-enrolled individual practitioners that have 
reassigned their right to receive Medicare payment for provision of RT 
services to the TIN of the RO participant must be included on the RO 
participant's individual practitioner list and each individual 
practitioner must agree to comply with the requirements of the RO Model 
before the RO participant certifies the individual practitioner list.
    (3) If the RO participant does not certify the individual 
practitioner list in PY2 through PY5:
    (i) Eligible clinicians in the RO Model will not be considered 
participants in a MIPS APM for purposes of MIPS reporting and scoring 
rules; and
    (ii) Eligible clinicians in the RO Model will not have Qualifying 
APM Participant (``QP'') determinations made based on their 
participation in the RO Model.
    (d) Changes to the individual practitioner list. (1) Additions.
    (i) An RO participant must notify CMS of an addition to its 
individual practitioner list within 30 days of when an eligible 
clinician reassigns his or her rights to receive payment from Medicare 
to the RO participant. The notice must be submitted in the form and 
manner specified by CMS.
    (ii) If the RO participant timely submits notice to CMS, then the 
addition of an individual practitioner to the RO participant's 
individual practitioner list is effective on the date specified in the 
notice furnished to CMS, but no earlier than 30 days before the date of 
the notice. If the RO participant fails to submit timely notice to CMS, 
then the addition of an individual practitioner to the individual 
practitioner list is effective on the date of the notice.
    (2) Removals. (i) An RO participant must notify CMS no later than 30 
days of when an individual on the RO participant's individual 
practitioner list ceases to be an individual practitioner. The notice 
must be submitted in the form and manner specified by CMS.
    (ii) The removal of an individual practitioner from the RO 
participant's individual practitioner list is effective on the date 
specified in the notice furnished to CMS. If the RO participant fails to 
submit a timely notice of the removal, then the removal is effective on 
the date that the individual ceases to be an individual practitioner.

[[Page 952]]

    (e) Update to Medicare enrollment information. The RO participant 
must ensure that all changes to enrollment information for an RO 
participant and its individual practitioners, including changes to 
reassignment of the right to receive Medicare payment, are reported to 
CMS consistent with Sec. 424.516 of this chapter.

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86304, Dec. 29, 2020]

    Editorial Note: At 85 FR 86304, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.



Sec. 512.220  RO participant compliance with RO Model requirements.

    (a) RO participant-specific requirements. (1) RO participants must 
satisfy the requirements of this section to qualify for the APM 
Incentive Payment.
    (2) Each Professional participant and Dual participant must ensure 
its individual practitioners:
    (i) Starting in PY1, discuss goals of care with each RO beneficiary 
before initiating treatment and communicate to the RO beneficiary 
whether the treatment intent is curative or palliative;
    (ii) Starting in PY1, adhere to nationally recognized, evidence-
based clinical treatment guidelines when appropriate in treating RO 
beneficiaries or, alternatively, document in the medical record the 
extent of and rationale for any departure from these guidelines;
    (iii) Starting in PY1, assess each RO beneficiary's tumor, node, and 
metastasis cancer stage for the CMS-specified cancer diagnoses;
    (iv) Starting in PY1, assess the RO beneficiary's performance status 
as a quantitative measure determined by the physician;
    (v) Starting in PY1, send a treatment summary to each RO 
beneficiary's referring physician within 3 months of the end of 
treatment to coordinate care;
    (vi) Starting in PY1, discuss with each RO beneficiary prior to 
treatment delivery his or her inclusion in, and cost-sharing 
responsibilities under, the RO Model; and
    (vii) Starting in PY1, perform and document Peer Review (audit and 
feedback on treatment plans) before 25 percent of the total prescribed 
dose has been delivered and within 2 weeks of the start of treatment 
for:
    (A) 50 percent of new patients in PY1,
    (B) 55 percent of new patients in PY2,
    (C) 60 percent of new patients in PY3,
    (D) 65 percent of new patients in PY4,
    (E) 70 percent of new patients in PY5.
    (3) Starting in PY1, at such times and in the form and manner 
specified by CMS, each Technical participant and Dual participant must 
annually attest to whether it actively participates with a AHRQ-listed 
patient safety organization (PSO). Examples include maintaining a 
contractual or similar relationship with a PSO for the receipt and 
review of patient safety work product.
    (b) CEHRT. Each RO participant must use CEHRT, and ensure that its 
individual practitioners use CEHRT, in a manner sufficient to meet the 
applicable requirements of the Advanced APM criteria codified in Sec. 
414.1415(a)(1)(i) of this chapter. Within 30 days of the start of PY2 
and each subsequent PY, each RO participant must certify in the form and 
manner, and by a deadline specified by CMS, that it uses CEHRT 
throughout such PY in a manner sufficient to meet the requirements set 
forth in Sec. 414.1415(a)(1)(i) of this chapter.

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86304, Dec. 29, 2020]

    Editorial Note: At 85 FR 86304, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.



Sec. 512.225  Beneficiary notification.

    (a) General. Starting in PY1, each Professional participant and Dual 
participant must notify each RO beneficiary to whom it furnishes 
included RT services--
    (1) That the RO participant is participating in the RO Model;
    (2) That the RO beneficiary has the opportunity to decline claims 
data sharing for care coordination and quality improvement purposes. If 
an RO beneficiary declines claims data sharing for care coordination and 
quality

[[Page 953]]

improvement purposes, then the RO participant must inform CMS within 30 
days of receiving notification from the RO beneficiary that the 
beneficiary is declining to have his or her claims data shared in that 
manner; and,
    (3) Of the RO beneficiary's cost-sharing responsibilities.
    (b) Form and manner of notification. Notification of the information 
specified in paragraph (a) of this section must be carried out by an RO 
participant by providing each RO beneficiary with a CMS-developed 
standardized written notice during the RO beneficiary's initial 
treatment planning session. The RO participants must furnish the notice 
to the RO beneficiary in the form and manner specified by CMS.
    (c) Applicability of general Innovation Center provisions. The 
beneficiary notifications under this section are not descriptive model 
materials and activities under Sec. 512.120(c). The requirement 
described in Sec. 512.120(c)(2) does not apply to the standardized 
written notice described in paragraph (b) of this section.

                    Scope of RO Episodes Being Tested



Sec. 512.230  Criteria for determining cancer types.

    (a) Included cancer types. CMS includes in the RO Model test cancer 
types that satisfy all of the following criteria. The cancer type:
    (1) Is commonly treated with radiation; and
    (2) Has associated current ICD-10 codes that have demonstrated 
pricing stability.
    (b) Removing cancer types. CMS removes cancer types in the RO Model 
if it determines:
    (1) RT is no longer appropriate to treat a cancer type per 
nationally recognized, evidence-based clinical treatment guidelines;
    (2) CMS discovers a [gteqt]10 percent error in established national 
base rates; or
    (3) The Secretary determines a cancer type not to be suitable for 
inclusion in the RO Model.
    (c) ICD-10 codes for included cancer types. CMS displays on the RO 
Model website no later than 30 days prior to each PY the ICD-10 
diagnosis codes associated with each included cancer type.



Sec. 512.235  Included RT services.

    (a) Only the following RT services furnished using an included 
modality identified at Sec. 512.240 for an included cancer type are 
included RT services that are paid for by CMS under Sec. 512.265:
    (1) Treatment planning;
    (2) Technical preparation and special services;
    (3) Treatment delivery; and,
    (4) Treatment management.
    (b) All other RT services furnished by an RO participant during the 
Model performance period are subject to Medicare FFS payment rules.



Sec. 512.240  Included modalities.

    The modalities included in the RO Model are 3-dimensional conformal 
RT (3DCRT), intensity-modulated RT (IMRT), stereotactic radiosurgery 
(SRS), stereotactic body RT (SBRT), proton beam therapy (PBT), image-
guided radiation therapy (IGRT), and brachytherapy.



Sec. 512.245  Included RO episodes.

    (a) General. Any RO episode that begins on or after July 1, 2021, 
and ends on or before December 31, 2025, is included in the Model 
performance period.
    (b) Death or election of hospice benefit. An RO episode is included 
in, and paid for under, the RO Model if the RO beneficiary dies after 
the TC of an RO episode has been initiated, or if the RO beneficiary 
elects the Medicare hospice benefit after the initial treatment planning 
service, provided that the TC is initiated within 28 days following the 
initial treatment planning service. Each RO participant will receive 
both installments of the episode payment under such circumstances, 
regardless of whether the RO beneficiary dies or elects the Medicare 
hospice benefit before the relevant course of RT treatment has ended.
    (c) Clean periods. An RO episode must not be initiated for the same 
RO beneficiary during a clean period.

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86305, Dec. 29, 2020]

[[Page 954]]


    Editorial Note: At 85 FR 86305, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.

                           Pricing Methodology



Sec. 512.250  Determination of national base rates.

    CMS determines a national base rate for the PC and TC for each 
included cancer type.
    (a) National base rates are the historical average cost for an 
episode of care for each of the included cancer types prior to the Model 
performance period.
    (b) National base rates are determined in the following manner:
    (1) CMS excludes claims from RT suppliers and RT providers in 
Maryland and Vermont and all inpatient and ASC claims from the 
construction of episodes and;
    (2) CMS excludes the following:
    (i) episodes with any RT services furnished by a CAH,
    (ii) episodes that are not attributed to an RT provider or RT 
supplier, and
    (iii) episodes in which either the PC or TC is attributed to an RT 
provider or RT supplier with a U.S. Territory service location.
    (3) CMS calculates the episode amount CMS paid on average to RT 
providers and RT suppliers for the PC and TC for each of the included 
cancer types in the HOPD setting, creating the RO Model's national base 
rates.



Sec. 512.255  Determination of participant-specific professional
episode payment and participant-specific technical episode payment 
amounts.

    (a) Thirty days before the start of each PY, CMS provides each RO 
participant its case mix and historical experience adjustments for both 
the PC and TC as calculated in paragraphs (c)(3) and (4) of this 
section. If an RO participant is not eligible to receive a historical 
experience adjustment or case mix adjustment as described under 
paragraph (c)(7) of this section, then CMS provides a zero value for 
those adjustments.
    (b) Any episode used to calculate the participant-specific 
professional episode payment amounts and the participant-specific 
technical episode payment amounts for an RO participant is subject to 
the exclusions described in Sec. 512.250(b)(1) and (2).
    (c) CMS calculates the participant-specific professional episode 
payment amounts and participant-specific technical episode payment 
amounts for each included cancer type using the following:
    (1) Trend factors. For every PY, CMS adjusts the national base rates 
for the PC and TC of each cancer type by calculating a separate trend 
factor for the PC and TC of each included cancer type.
    (2) Geographic adjustment. CMS adjusts the trended national base 
rates prior to applying each RO participant's case mix and historical 
experience, and prior to applying the discounts and withholds, for local 
cost and wage indices based on where RT services are furnished, as 
described by existing geographic adjustment processes in the OPPS and 
PFS.
    (3) Case mix adjustment. CMS establishes and applies a case mix 
adjustment to the national base rate after the trend factor and 
geographic adjustment have applied. The case mix adjustment reflects 
episode or RO episode characteristics that may be beyond the control of 
RO participants such as cancer type, age, sex, presence of a major 
procedure, death during the episode, and presence of chemotherapy.
    (4) Historical experience adjustment. CMS establishes and applies a 
historical experience adjustment to the national base rate after the 
trend factor, geographic adjustment, and case mix adjustment have been 
applied. The historical experience adjustments reflect each RO 
participant's actual historical experience.
    (5) Blend. CMS blends each RO participant's historical experience 
adjustment and the geographically-adjusted trended national base rate. 
The blend for RO participants with a professional historical experience 
adjustment or technical historical experience adjustment with a value 
equal to or less than zero is 90/10, meaning the calculation of the 
participant-specific episode payment amount is weighted according to 90 
percent of the RO participant's historical experience adjustment and 10 
percent of the geographically-adjusted

[[Page 955]]

trended national base for PY1 through PY5. The blend for RO participants 
with a professional historical experience adjustment or technical 
historical experience adjustment of more than zero is 90/10 in PY1, 85/
15 in PY2, 80/20 in PY3, 75/25 in PY4, and 70/30 in PY5.
    (6) Changes in business structure. (i) RO participants must notify 
CMS in writing of a merger, acquisition, or other new clinical or 
business relationship, at least 90 days before the date of the change as 
described in Sec. 424.516.
    (ii) CMS updates case mix and historical experience adjustments 
according to the relevant treatment history that applies as a result of 
a merger, acquisition, or other new clinical or business relationship in 
the RO participant's case mix and historical experience adjustment 
calculations from the effective date of the change.
    (7) Adjustments for RO participants with fewer than 60 episodes 
during 2016-2018.
    (i) RO participants that have fewer than 60 episodes from 2016-2018 
do not receive a historical experience adjustment during the Model 
performance period.
    (ii) RO participants that have fewer than 60 episodes from 2016-2018 
do not receive a case mix adjustment for PY1.
    (iii) RO participants described in Sec. 512.255(b)(7)(ii) that 
continue to have fewer than 60 episodes in the rolling 3-year period 
used to determine the case mix adjustment for each PY (2017-2019 for 
PY2, 2018-2020 for PY3, 2019-2021 for PY4, and 2020-2022 for PY5) and 
that have never received a case mix adjustment do not receive a case mix 
adjustment for that PY.
    (iv) RO participants that have fewer than 60 episodes from 2016-2018 
and were furnishing included RT services in the CBSAs selected for 
participation on November 30, 2020 are eligible to receive a stop-loss 
reconciliation amount, if applicable, for the loss incurred under the RO 
Model as described in Sec. 512.285(f).
    (8) Discount factor. CMS deducts a percentage discount from each 
episode payment after applying the trend factor, geographic adjustment, 
and case mix and historical experience adjustments to the national base 
rate. The discount factor for the PC is 3.75 percent. The discount 
factor for TC is 4.75 percent.
    (9) Incorrect payment withhold. To account for duplicate RT services 
and incomplete episodes:
    (i) CMS withholds from each RO participant 1 percent from each 
episode payment, after applying the trend factor, geographic adjustment, 
case mix and historical experience adjustments, and discount to the 
national base rate.
    (ii) CMS determines during the annual reconciliation process set 
forth at Sec. 512.285 whether an RO participant is eligible to receive 
a portion or all of the withheld amount or whether any payment is owed 
to CMS.
    (10) Quality withhold. In accordance with Sec. 414.1415(b)(1) of 
this chapter, CMS withholds 2 percent from each professional episode 
payment after applying the trend factor, geographic adjustment, case mix 
and historical experience adjustments, and discount factor to the 
national base rate starting in PY2. RO participants may earn back this 
withhold, in part or in full, based on their AQS.
    (11) Patient experience withhold. Starting in PY3,
    (i) CMS withholds 1 percent from each technical episode payment 
after applying the trend factor, geographic adjustment, case mix and 
historical experience adjustments, and discount factor to the national 
base rate.
    (ii) RO participants may earn back their patient-experience 
withhold, in part or in full, based on their results from the 
CAHPS[supreg] Cancer Care Radiation Therapy survey.
    (12) Coinsurance. RO participants may collect beneficiary 
coinsurance payments for services furnished under the RO Model in 
multiple installments under a payment plan.
    (i) The availability of payment plans may not be used as a marketing 
tool to influence beneficiary choice of health care provider.
    (ii) RO participants offering a payment plan may inform the RO 
beneficiary of the availability of the payment plan prior to or during 
the initial treatment planning session and as necessary thereafter.
    (iii) The beneficiary coinsurance payment equals 20 percent of the 
episode payment amount to be paid to the RO

[[Page 956]]

participant(s) prior to the application of sequestration for the billed 
RO Model-specific HCPCS code with a SOE modifier and for the billed RO 
Model-specific HCPCS code with an EOE modifier for the PC and TC, except 
as provided in paragraph (c)(12)(iv) and(v) of this section.
    (iv) In the case of incomplete episodes
    (A) The beneficiary coinsurance payment equals 20 percent of the FFS 
amounts that would have been paid in the absence of the RO Model for the 
services furnished by the RO participant that initiated the PC and the 
RO participant that initiated the TC (if applicable), except for a 
subset of incomplete episodes described in paragraph (c)(12)(iv)(B); or
    (B) If an RO beneficiary ceases to have traditional FFS Medicare as 
his or her primary payer any time after the initial treatment planning 
service is furnished and before the date of service on a claim with an 
RO Model-specific HCPCS code and EOE modifier, provided a Technical 
participant or the same Dual participant that provided the initial 
treatment planning service furnishes a a technical component RT service 
to the RO beneficiary within 28 days of such initial treatment planning 
service, the beneficiary coinsurance payment equals 20 percent of the 
first installment of the episode payment amount to be paid to the RO 
participant(s) prior to the application of sequestration for the billed 
RO Model-specific HCPCS code with an SOE modifier for the PC and TC. If 
an RO participant bills the RO Model-specific HCPCS code and EOE 
modifier with a date of service that is prior to the date that the RO 
beneficiary ceases to have traditional FFS Medicare, then the 
beneficiary coinsurance payment equals 20 percent of the full episode 
payment amount for the PC or TC, as applicable.
    (v) In the case of duplicate RT services, the beneficiary 
coinsurance payment equals 20 percent of the episode payment amount to 
be paid to the RO participant(s) per Sec. 512.255(c)(12)(iii) and 20 
percent of the FFS amount to the RT provider and/or RT supplier 
furnishing one or more duplicate RT services.
    (13) Sequestration. CMS deducts 2 percent from each episode payment 
after applying the trend factor, geographic adjustment, case mix and 
historical experience adjustments, discount, withholds, and coinsurance 
to the national base rate.

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86305, Dec. 29, 2020]

    Editorial Note: At 85 FR 86305, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.

                           Billing and Payment



Sec. 512.260  Billing.

    (a) Reassignment of billing rights. Each Professional participant 
and Dual participant must ensure that its individual practitioners 
reassign their billing rights to the TIN of the Professional participant 
or Dual participant.
    (b) Billing under the RO Model. (1) Professional participants and 
Dual participants must bill an RO Model-specific HCPCS code and a SOE 
modifier to indicate that the treatment planning service has been 
furnished and that an RO episode has been initiated.
    (2) Dual participants and Technical participants must bill an RO 
Model-specific HCPCS code and SOE modifier to indicate that a treatment 
delivery service was furnished.
    (3) RO participants must bill the same RO Model-specific HCPCS code 
that initiated the RO episode and an EOE modifier to indicate that the 
RO episode has ended.
    (4) RO participants may submit a claim with an EOE modifier only 
after the RT course of treatment has ended, except that such claim must 
not be submitted earlier than 28 days after the date of the initial 
treatment planning service.
    (c) Billing for RT services performed during a clean period. RO 
participants must bill for any medically necessary RT services furnished 
to an RO beneficiary during a clean period in accordance with existing 
FFS billing processes in the OPPS and PFS.
    (d) Submission of no-pay claims. RO participants must submit no-pay 
claims for any medically necessary included RT services furnished to an 
RO

[[Page 957]]

beneficiary during an RO episode pursuant to existing FFS billing 
processes in the OPPS and PFS.



Sec. 512.265  Payment.

    (a) Payment for episodes. CMS pays an RO participant for all 
included RT services furnished to an RO beneficiary during a completed 
RO episode as follows:
    (1) CMS pays a Professional participant a participant-specific 
professional episode payment for the professional component furnished to 
an RO beneficiary during an RO episode.
    (2) CMS pays a Technical participant a participant-specific 
technical episode payment for the technical component furnished to an RO 
beneficiary during an RO episode.
    (3) CMS pays a Dual participant a participant-specific professional 
episode payment and a participant-specific technical episode payment for 
the professional component and technical component furnished to an RO 
beneficiary during an RO episode.
    (b) Payment installments. CMS makes each of the payments described 
in paragraph (a) of this section in two equal installments, as follows:
    (1) CMS pays one-half of a participant-specific professional episode 
payment to a Professional participant or Dual participant or one-half of 
the participant-specific technical episode payment to a Technical 
participant or Dual participant after the RO participant bills an RO 
Model-specific HCPCS code with a SOE modifier.
    (2) CMS pays the remaining half of a participant-specific 
professional episode payment to a Professional participant or Dual 
participant or one-half of the participant-specific technical episode 
payment to a Technical participant or Dual participant after the RO 
participant bills an RO Model-specific HCPCS code with an EOE modifier.
    (c) Duplicate RT services. Duplicate RT services are reimbursed at 
the FFS amount, whether or not the RT provider or RT supplier that 
furnished such services is an RO participant.



Sec. 512.270  Treatment of add-on payments under existing Medicare 
payment systems.

    (a) CMS does not make separate Medicare FFS payments to RO 
participants for any included RT services that are furnished to an RO 
beneficiary during an RO episode.
    (b) An RO participant may receive Medicare FFS payment for items and 
services furnished to an RO beneficiary during an RO episode, provided 
that any such other item or service is not an included RT service.

                             Data Reporting



Sec. 512.275  Quality measures, clinical data, and reporting.

    (a) Data privacy compliance. The RO participant must--
    (1) Comply with all applicable laws pertaining to any patient-
identifiable data requested from CMS under the terms of the Innovation 
Center model, including any patient-identifiable derivative data, as 
well as the terms of any attestation or agreement entered into by the RO 
participant with CMS as a condition of receiving that data. Such laws 
may include, without limitation, the privacy and security rules 
promulgated under the Health Insurance Portability and Accountability 
Act of 1996 (HIPAA), as modified, and the Health Information Technology 
for Economic and Clinical Health Act (HITECH).
    (2) Contractually bind all downstream recipients of CMS data to the 
same terms and conditions to which the RO participant was itself bound 
in its agreements with CMS as a condition of the downstream recipient's 
receipt of the data from the RO participant.
    (b) RO participant public release of patient de-identified 
information. The RO participant must include the disclaimer codified at 
Sec. 512.120(c)(2) on the first page of any publicly-released document, 
the contents of which materially and substantially references or is 
materially and substantially based upon the RO participant's 
participation in the RO Model, including but not

[[Page 958]]

limited to press releases, journal articles, research articles, 
descriptive articles, external reports, and statistical/analytical 
materials.
    (c) Reporting quality measures and clinical data elements. In 
addition to reporting described in other provisions in this part, 
Professional participants and Dual participants must report selected 
quality measures on all patients and clinical data elements describing 
cancer stage, disease characteristics, treatment intent, and specific 
treatment plan information on beneficiaries treated for specified cancer 
types, in the form, manner, and at a time specified by CMS.

                        Medicare Program Waivers



Sec. 512.280  RO Model Medicare program waivers.

    (a) General. The Secretary may waive certain requirements of title 
XVIII of the Act as necessary solely for purposes of testing of the RO 
Model. Such waivers apply only to the participants in the RO Model.
    (b) Hospital Outpatient Quality Reporting (OQR) Program. CMS waives 
the application of the Hospital OQR Program 2.0 percentage point 
reduction under section 1833(t)(17) of the Act for only those Ambulatory 
Payment Classifications (APCs) that include only RO Model-specific HCPCS 
codes during the Model performance period.
    (c) Merit-based Incentive Payment System (MIPS). CMS waives the 
requirement under section 1848(q)(6)(E) of the Act and Sec. 414.1405(e) 
of this chapter to apply the MIPS payment adjustment factor, and, as 
applicable, the additional MIPS payment adjustment factor (collectively 
referred to as the MIPS payment adjustment factors) to the TC of RO 
Model payments to the extent that the MIPS payment adjustment factors 
would otherwise apply to the TC of RO Model payments.
    (d) APM Incentive Payment. CMS waives the requirements of Sec. 
414.1450(b) of this chapter such that technical component payment 
amounts under the RO Model shall not be considered in calculation of the 
aggregate payment amount for covered professional services as defined in 
section 1848(k)(3)(A) of the Act for the APM Incentive Payment made 
under Sec. 414.1450(b)(1) of this chapter.
    (e) PFS Relativity Adjuster. CMS waives the requirement to apply the 
PFS Relativity Adjuster to RO Model-specific APCs for RO participants 
that are non-excepted off-campus provider-based departments (PBDs) 
identified by section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 
114-74), which amended section 1833(t)(1)(B)(v) and added paragraph 
(t)(21) to the Social Security Act.
    (f) General payment waivers. CMS waives the following sections of 
the Act solely for the purposes of testing the RO Model:
    (1) 1833(t)(1)(A).
    (2) 1833(t)(16)(D).
    (3) 1848(a)(1).
    (4) 1833(t)(2)(H).
    (5) 1869 claims appeals procedures.

                    Reconciliation and Review Process



Sec. 512.285  Reconciliation process.

    (a) General. CMS conducts an initial reconciliation and a true-up 
reconciliation for each RO participant for each PY in accordance with 
this section.
    (b) Annual reconciliation calculations. (1) To determine the 
reconciliation payment or the repayment amount based on RO episodes 
initiated in a PY, CMS performs the following steps:
    (i) CMS calculates an RO participant's incorrect episode payment 
reconciliation amount as described in paragraph (c) of this section.
    (ii) CMS calculates the RO participant's quality reconciliation 
amount as described in paragraph (d) of this section, if applicable.
    (iii) CMS calculates the RO participant's patient experience 
reconciliation amount, as described in paragraph (e) of this section, if 
applicable.
    (iv) CMS calculates the stop-loss reconciliation amount, as 
described in paragraph (f) of this section, if applicable.
    (v) CMS adds, as applicable, the incorrect episode payment 
reconciliation amount, any quality reconciliation payment amount, any 
patient experience reconciliation amount, and any stop-loss 
reconciliation payment

[[Page 959]]

amount. The sum of these amounts results in a reconciliation payment or 
repayment amount.
    (2) CMS calculations use claims data available at the time of 
reconciliation.
    (c) Incorrect episode payment reconciliation amount. CMS calculates 
the incorrect episode payment reconciliation amount as follows:
    (1) Total incorrect payment withhold amount. CMS calculates the 
total incorrect payment withhold amount by adding the incorrect payment 
withhold amount for each episode initiated in the PY.
    (2) Total duplicate RT services amount. CMS calculates the total 
duplicate RT services amount by adding all FFS amounts for duplicate RT 
services furnished during each episode initiated in the PY. The 
duplicate RT services amount is capped for each episode and will not be 
more than the participant-specific professional episode payment amount 
or participant-specific technical episode payment amount received by the 
RO participant for an RO episode, even if the duplicate RT services 
amount exceeds the participant-specific professional episode payment 
amount or the participant-specific technical episode payment amount.
    (3) Total incomplete episode amount. CMS calculates the total 
incomplete episode amount for a subset of incomplete episodes.
    (i) Incomplete episodes in which an RO beneficiary ceases to have 
traditional FFS Medicare as his or her primary payer at any time after 
the initial treatment planning service is furnished and before the date 
of service on a claim with an RO Model-specific HCPCS code and EOE 
modifier, provided an RO participant furnishes a technical component RT 
service to the RO beneficiary within 28 days of such initial treatment 
planning service, are not included in the incomplete episode amount.
    (ii) For all other incomplete episodes initiated in the PY, CMS 
determines the total incomplete episode amount by calculating the 
difference between the following amounts:
    (A) The sum of all FFS amounts that would have been paid to the RO 
participant in the absence of the RO Model for any included RT services 
furnished during such incomplete episodes, as determined by no-pay 
claims. This sum is what CMS owes the RO participant for such incomplete 
episodes.
    (B) The sum of the participant-specific episode payment amounts paid 
to the relevant RO participant for such incomplete episodes initiated in 
the PY.
    (4) Total incorrect episode payment amount. CMS calculates the total 
incorrect episode payment amount as follows:
    (i) If the sum described in paragraph (c)(3)(ii)(A) of this section 
is more than the sum described in paragraph (c)(3)(ii)(B) of this 
section, the difference is subtracted from the total duplicate RT 
services amount and the resulting amount is the total incorrect episode 
payment amount.
    (ii) If the sum described in paragraph (c)(3)(ii)(A) of this section 
is less than the sum described in paragraph (c)(3)(ii)(B) of this 
section, the difference is added to the total duplicate RT services 
amount and the resulting amount is the total incorrect episode payment 
amount.
    (5) Incorrect episode payment reconciliation amount. If the total 
incorrect episode payment amount represents money owed by the RO 
participant to CMS, CMS subtracts the total incorrect episode payment 
amount from the total incorrect payment withhold amount. In the case 
that the total incorrect episode payment amount represents money owed by 
CMS to the RO participant, CMS adds the total incorrect episode payment 
amount to the total incorrect payment withhold amount. The resulting 
amount is the RO participant's incorrect episode payment reconciliation 
amount.
    (d) Quality reconciliation payment amount. For Professional 
participants and Dual participants, CMS determines the quality 
reconciliation payment amount for PY2 through PY5 by multiplying the 
participant's AQS (as a percentage) by the total quality withhold amount 
for all RO episodes initiated during the PY. There is no quality 
reconciliation payment amount for PY1.
    (e) Patient experience reconciliation amount. For PY3 and subsequent 
PYs, CMS determines the patient experience

[[Page 960]]

reconciliation amount for RO participants by multiplying the 
participant's AQS (as a percentage) by the total patient experience 
withhold amount for all RO episodes initiated during the PY.
    (f) Stop-loss reconciliation amount. CMS determines the stop-loss 
reconciliation amount for RO participants that have fewer than 60 
episodes during 2016 through 2018 and were furnishing included RT 
services at November 30, 2020 in the CBSAs selected for participation 
by--
    (1) Using no-pay claims, CMS calculates the total FFS amount by 
summing the FFS amounts that would have been paid to the RO participant 
in the absence of the RO Model for all included RT services furnished 
during the RO episodes initiated in the PY; and
    (2) CMS calculates the sum of all participant-specific professional 
episode payments and participant-specific technical episode payments 
paid to the RO participant for the RO episodes initiated in the PY.
    (3) If the total FFS amount exceeds the sum of the participant-
specific episode payment amounts for the PY by more than 20 percent then 
CMS owes the RO participant the amount that exceeds 20 percent, either 
increasing the amount of the RO participant's reconciliation payment or 
reducing the amount of the RO's participant's reconciliation repayment.
    (g) True-up reconciliation. CMS conducts a true-up reconciliation in 
the same manner described in paragraph (b) of this section (except that 
the quality reconciliation payment amount and the patient experience 
reconciliation amount are not calculated) to determine any additional 
reconciliation payment or repayment amount that are identified using 12-
months of claims run-out.
    (h) Reconciliation report. CMS issues each RO participant a 
reconciliation report for each PY. Each reconciliation report contains 
the following:
    (1) The RO participant's reconciliation payment or repayment amount, 
if any, for the relevant PY.
    (2) Any additional reconciliation payment or repayment amount owed 
for a previous PY as a result of the true-up reconciliation.
    (3) The net reconciliation payment or repayment amount owed.
    (i) Payment of amounts owed. (1) CMS issues a reconciliation payment 
to the RO participant in the amount specified in the reconciliation 
report 30 days after the reconciliation report is deemed final.
    (2) The RO participant must pay a repayment amount to CMS in the 
amount specified in the reconciliation report by a deadline specified by 
CMS. If the RO participant fails to timely pay the full repayment 
amount, CMS recoups the repayment amount from any payments otherwise 
owed by CMS to the RO participant, including Medicare payments for items 
and services unrelated to the RO Model.
    (3) No coinsurance is owed by an RO beneficiary with respect to any 
repayment amount or reconciliation payment.

[85 FR 61362, Sept. 29, 2020, as amended at 85 FR 86305, Dec. 29, 2020]

    Editorial Note: At 85 FR 86305, Dec. 29, 2020, this section was 
amended, effective Dec. 4, 2020; however, due to a publication error, 
the amendments were codified at 86 FR 33902, June 28, 2021.



Sec. 512.290  Timely error notice and reconsideration review process.

    (a) Timely error notice. Subject to the limitations on review in 
Sec. 512.170, an RO participant that identifies and wishes to contest a 
suspected error in the calculation of its reconciliation payment or 
repayment amount or AQS must provide written notice of the suspected 
calculation error to CMS within 45 days of the date of the 
reconciliation report. Such timely error notice must be in a form and 
manner specified by CMS. RO participants are not permitted to contest 
the RO Model pricing methodology or AQS methodology.
    (1) Unless a timely error notice is received by CMS within 45 days 
of the date of issuance of a reconciliation report, the reconciliation 
payment or repayment amount determination specified in that 
reconciliation report is deemed binding and not subject to further 
review.
    (2) If CMS receives a timely error notice, then CMS responds in 
writing

[[Page 961]]

within 30 days either to confirm that there was an error in the 
calculation or to verify that the calculation is correct. CMS may extend 
the deadline for its response upon written notice to the RO participant.
    (3) Only the RO participant may use the timely error notice process 
described in this paragraph and the reconsideration review process 
described in paragraph (b) of this section.
    (b) Reconsideration review. (1) Reconsideration request by an RO 
participant. (i) If the RO participant is dissatisfied with CMS' 
response to the timely error notice, then the RO participant may request 
a reconsideration review as specified in paragraph (b)(2) of this 
section.
    (ii) If CMS does not receive a request for reconsideration from the 
RO participant within 10 days of the issue date of CMS' response to the 
RO participant's timely error notice, then CMS' response to the timely 
error notice is deemed binding and not subject to further review.
    (2) Submission of a reconsideration request. (i) Information needed 
in the reconsideration request. The reconsideration review request 
must--
    (A) Provide a detailed explanation of the basis for the dispute; and
    (B) Include supporting documentation for the RO participant's 
assertion that CMS or its representatives did not accurately calculate 
the reconciliation payment or repayment amount or AQS in accordance with 
the terms of this subpart.
    (3) Form, manner, and deadline for submission of the reconsideration 
request. The information specified in paragraph (b)(2)(i) of this 
section must be submitted--
    (i) In a form and manner specified by CMS; and
    (ii) Within 10 days of the date of the CMS response described in 
paragraph (a)(2) of this section.
    (4) Designation of and notification from a CMS-designated 
reconsideration official.
    (i) Designation of reconsideration official. CMS designates a 
reconsideration official who--
    (A) Is authorized to receive such requests; and
    (B) Was not involved in the responding to the RO participant's 
timely error notice.
    (ii) Notification to the RO participant. The CMS-designated 
reconsideration official makes reasonable efforts to notify the RO 
participant and CMS in writing within 15 days of receiving the RO 
participant's reconsideration review request of the following:
    (A) The issue(s) in dispute;
    (B) The briefing schedule; and
    (C) The review procedures.
    (5) Resolution review. The CMS reconsideration official makes all 
reasonable efforts to complete the on-the-record resolution review and 
issue a written determination no later than 60 days after the submission 
of the final position paper in accordance with the reconsideration 
official's briefing schedule.



                 Subpart C_ESRD Treatment Choices Model

                                 General



Sec. 512.300  Basis and scope.

    (a) Basis. This subpart implements the test of the End-Stage Renal 
Disease (ESRD) Treatment Choices (ETC) Model under section 1115A(b) of 
the Act. Except as specifically noted in this subpart, the regulations 
under this subpart must not be construed to affect the applicability of 
other provisions affecting providers and suppliers under Medicare FFS, 
including the applicability of provisions regarding payment, coverage, 
or program integrity.
    (b) Scope. This subpart sets forth the following:
    (1) The duration of the ETC Model.
    (2) The method for selecting ETC Participants.
    (3) The schedule and methodologies for the Home Dialysis Payment 
Adjustment and Performance Payment Adjustment.
    (4) The methodology for ETC Participant performance assessment for 
purposes of the Performance Payment Adjustment, including beneficiary 
attribution, benchmarking and scoring, and calculating the Modality 
Performance Score.
    (5) Monitoring and evaluation, including quality measure reporting.

[[Page 962]]

    (6) Medicare payment waivers.



Sec. 512.310  Definitions.

    For purposes of this subpart, the following definitions apply.
    Adjusted ESRD PPS per Treatment Base Rate means the per treatment 
payment amount as defined in Sec. 413.230 of this chapter, including 
patient-level adjustments and facility-level adjustments, and excluding 
any applicable training adjustment, add-on payment amount, outlier 
payment amount, transitional drug add-on payment adjustment (TDAPA) 
amount, and transitional add-on payment adjustment for new and 
innovative equipment and supplies (TPNIES) amount.
    Benchmark Year (BY) means the 12-month period that begins 18 months 
prior to the start of a given measurement year (MY) from which data are 
used to construct benchmarks against which to score an ETC Participant's 
achievement and improvement on the home dialysis rate and transplant 
rate for the purpose of calculating the ETC Participant's MPS.
    Clinician Home Dialysis Payment Adjustment (Clinician HDPA) means 
the payment adjustment to the MCP for a Managing Clinician who is an ETC 
Participant, for the Managing Clinician's home dialysis claims, as 
described in Sec. Sec. 512.345 and 512.350.
    Clinician Performance Payment Adjustment (Clinician PPA) means the 
payment adjustment to the MCP for a Managing Clinician who is an ETC 
Participant based on the Managing Clinician's MPS, as described in 
Sec. Sec. 512.375(b) and 512.380.
    Comparison Geographic Area(s) means those HRRs that are not Selected 
Geographic Areas.
    ESRD Beneficiary means a beneficiary who meets either of the 
following:
    (1) Is receiving dialysis or other services for end-stage renal 
disease, up to and including the month in which the beneficiary receives 
a kidney transplant up to and including the month in which the 
beneficiary receives a kidney transplant.
    (2) Has already received a kidney transplant and has a non-AKI 
dialysis or MCP claim--
    (i) At least 12 months after the beneficiary's latest transplant 
date; or
    (ii) Less than 12 months after the beneficiary's latest transplant 
date and has a kidney transplant failure diagnosis code documented on 
any Medicare claim.
    ESRD facility means an ESRD facility as specified in Sec. 413.171 
of this chapter.
    ETC Participant means an ESRD facility or Managing Clinician that is 
required to participate in the ETC Model pursuant to Sec. 512.325(a).
    Facility Home Dialysis Payment Adjustment (Facility HDPA) means the 
payment adjustment to the Adjusted ESRD PPS per Treatment Base Rate for 
an ESRD facility that is an ETC Participant for the ESRD facility's home 
dialysis claims, as described in Sec. Sec. 512.340 and 512.350.
    Facility Performance Payment Adjustment (Facility PPA) means the 
payment adjustment to the Adjusted ESRD PPS per treatment base rate for 
an ESRD facility that is an ETC Participant based on the ESRD facility's 
MPS, as described in Sec. Sec. 512.375(a) and 512.380.
    Home Dialysis Payment Adjustment (HDPA) means either the Facility 
HDPA or the Clinician HDPA.
    Home dialysis rate means the rate of ESRD Beneficiaries attributed 
to the ETC Participant who dialyzed at home during the relevant MY, as 
described in Sec. 512.365(b).
    Hospital referral regions (HRRs) means the regional markets for 
tertiary medical care derived from Medicare claims data as defined by 
the Dartmouth Atlas Project at https://www.dartmouthatlas.org/.
    Kidney transplant means a kidney transplant, alone or in conjunction 
with any other organ.
    Living donor transplant (LDT) Beneficiary means an ESRD Beneficiary 
who received a kidney transplant from a living donor.
    Living donor transplant rate means the rate of ESRD Beneficiaries 
and, if applicable, Pre-emptive LDT Beneficiaries attributed to the ETC 
Participant who received a kidney transplant from a living donor during 
the MY, as described in Sec. 512.365(c)(1)(ii) and Sec. 
512.365(c)(2)(ii).
    Managing Clinician means a Medicare-enrolled physician or non-
physician practitioner, identified by a National Provider Identifier 
(NPI), who

[[Page 963]]

furnishes and bills the MCP for managing one or more adult ESRD 
Beneficiaries.
    Measurement Year (MY) means the 12-month period for which 
achievement and improvement on the home dialysis rate and transplant 
rate are assessed for the purpose of calculating the ETC Participant's 
MPS and corresponding PPA. Each MY included in the ETC Model and its 
corresponding PPA Period are specified in Sec. 512.355(c).
    Modality Performance Score (MPS) means the numeric performance score 
calculated for each ETC Participant based on the ETC Participant's home 
dialysis rate and transplant rate, as described in Sec. 512.370(a), 
which is used to determine the amount of the ETC Participant's PPA, as 
described in Sec. 512.380.
    Monthly capitation payment (MCP) means the monthly capitated payment 
made for each ESRD Beneficiary to cover all routine professional 
services related to treatment of the patient's renal condition furnished 
by the physician or non-physician practitioner as specified in Sec. 
414.314 of this chapter.
    National Provider Identifier (NPI) means the standard unique health 
identifier used by health care providers for billing payors, assigned by 
the National Plan and Provider Enumeration System (NPPES) in 45 CFR part 
162.
    Performance Payment Adjustment (PPA) means either the Facility PPA 
or the Clinician PPA.
    Performance Payment Adjustment Period (PPA Period) means the six-
month period during which a PPA is applied in accordance with Sec. 
512.380.
    Pre-emptive LDT Beneficiary means a beneficiary who received a 
kidney transplant from a living donor prior to beginning dialysis.
    Selected Geographic Area(s) are those HRRs selected by CMS pursuant 
to Sec. 512.325(b) for purposes of selecting ESRD facilities and 
Managing Clinicians required to participate in the ETC Model as ETC 
Participants.
    Subsidiary ESRD facility is an ESRD facility owned in whole or in 
part by another legal entity.
    Taxpayer Identification Number (TIN) means a Federal taxpayer 
identification number or employer identification number as defined by 
the Internal Revenue Service in 26 CFR 301.6109-1.
    Transplant rate means the sum of the transplant waitlist rate and 
the living donor transplant rate, as described in Sec. 512.365(c).
    Transplant waitlist rate means the rate of ESRD Beneficiaries 
attributed to the ETC Participant who were on the kidney transplant 
waitlist during the MY, as described in Sec. 512.365(c)(1)(i)-(ii) and 
Sec. 512.365(c)(2)(i)-(ii).

           ESRD Treatment Choices Model Scope and Participants



Sec. 512.320  Duration.

    CMS will apply the payment adjustments described in this subpart 
under the ETC Model to claims with claim service dates beginning on or 
after January 1, 2021, and ending on or before June 30, 2027.



Sec. 512.325  Participant selection and geographic areas.

    (a) Selected participants. All Medicare-certified ESRD facilities 
and Medicare-enrolled Managing Clinicians located in a selected 
geographic area are required to participate in the ETC Model.
    (b) Selected Geographic Areas. CMS establishes the Selected 
Geographic Areas by selecting all HRRs for which at least 20 percent of 
the component zip codes are located in Maryland, and a random sample of 
30 percent of HRRs, stratified by Census-defined regions (Northeast, 
South, Midwest, and West). CMS excludes all U.S. Territories from the 
Selected Geographic Areas.



Sec. 512.330  Beneficiary notification.

    (a) General. ETC Participants must prominently display informational 
materials in each of their office or facility locations where 
beneficiaries receive treatment to notify beneficiaries that the ETC 
Participant is participating in the ETC Model. CMS provides the ETC 
Participant with a template for these materials, indicating the required 
content that the ETC Participant must not change and places where the 
ETC Participant may insert its own original content. The CMS-provided 
template for the beneficiary notification will include, without 
limitation, the following information:

[[Page 964]]

    (1) A notification that the ETC Participant is participating in the 
ETC Model;
    (2) Instructions on how to contact the ESRD Network Organizations 
with any questions or concerns about the ETC Participant's participation 
in the Model;
    (3) An affirmation of the ESRD Beneficiary's protections under 
Medicare, including the beneficiary's freedom to choose his or her 
provider or supplier and to select the treatment modality of his or her 
choice.
    (b) Applicability of general Innovation Center model provisions. The 
requirement described in Sec. 512.120(c)(2) shall not apply to the CMS-
provided materials described in paragraph (a) of this section. All other 
ETC Participant communications that are descriptive model materials and 
activities as defined under Sec. 512.110 must meet the requirements 
described in Sec. 512.120(c).

                    Home Dialysis Payment Adjustment



Sec. 512.340  Payments subject to the Facility HDPA.

    CMS adjusts the Adjusted ESRD PPS per Treatment Base Rate by the 
Facility HDPA on claim lines with Type of Bill 072X, and with condition 
codes 74 or 76, when the claim is submitted by an ESRD facility that is 
an ETC Participant with a claim service date during a calendar year 
subject to adjustment as described in Sec. 512.350 and the beneficiary 
is at least 18 years old before the first day of the month.



Sec. 512.345  Payments subject to the Clinician HDPA.

    CMS adjusts the amount otherwise paid under Medicare Part B with 
respect to MCP claims on claim lines with CPT codes 90965 and 90966 by 
the Clinician HDPA when the claim is submitted by a Managing Clinician 
who is an ETC Participant with a claim service date during a calendar 
year subject to adjustment as described in Sec. 512.350 and the 
beneficiary is at least 18 years old before the first day of the month.



Sec. 512.350  Schedule of home dialysis payment adjustments.

    CMS adjusts the payments specified in Sec. 512.340 by the Facility 
HDPA and adjusts the payments specified in Sec. 512.345 by the 
Clinician HDPA, according to the following schedule:
    (a) Calendar year 2021: +3 percent.
    (b) Calendar year 2022: +2 percent.
    (c) Calendar year 2023: +1 percent.

                     Performance Payment Adjustment



Sec. 512.355  Schedule of performance assessment and performance
payment adjustment.

    (a) Measurement Years. CMS assesses ETC Participant performance on 
the home dialysis rate and the transplant rate during each of the MYs. 
The first MY begins on January 1, 2021, and the final MY ends on June 
30, 2026.
    (b) Performance Payment Adjustment Period. CMS adjusts payments for 
ETC Participants by the PPA during each of the PPA Periods, each of 
which corresponds to a MY. The first PPA Period begins on July 1, 2022, 
and the final PPA Period ends on June 30, 2027.
    (c) Measurement Years and Performance Payment Adjustment Periods. 
MYs and PPA Periods follow the following schedule:

[[Page 965]]

[GRAPHIC] [TIFF OMITTED] TR29SE20.030



Sec. 512.360  Beneficiary population and attribution.

    (a) General. Except as provided in paragraph (b) of this section, 
CMS attributes ESRD Beneficiaries to an ETC Participant for each month 
during a MY based on the ESRD Beneficiary's receipt of services 
specified in paragraph (c) of this section during that month, for the 
purpose of assessing the ETC Participant's performance on the home 
dialysis rate and transplant rate during that MY. Except as provided in 
paragraph (b) of this section, CMS attributes Pre-emptive LDT 
Beneficiaries to a Managing Clinician for one or more months during a MY 
based on the Pre-emptive LDT Beneficiary's receipt of services specified 
in paragraph (c)(2) of this section during that MY, for the purpose of 
assessing the Managing Clinician's performance on the living donor 
transplant rate during that MY. CMS attributes ESRD Beneficiaries and, 
if applicable, Pre-emptive LDT Beneficiaries to the ETC Participant for 
each month during a MY retrospectively after the end of the MY. CMS 
attributes an ESRD Beneficiary to no more than one ESRD facility and no 
more than one Managing Clinician for a given month during a given MY. 
CMS attributes a Pre-emptive LDT Beneficiary to no more than one 
Managing Clinician for a given MY.
    (b) Exclusions from attribution. CMS does not attribute an ESRD 
Beneficiary or Pre-emptive LDT Beneficiary to an ETC Participant for a 
month if, at any point during the month, the beneficiary--
    (1) Is not enrolled in Medicare Part B;
    (2) Is enrolled in Medicare Advantage, a cost plan, or other 
Medicare managed care plan;
    (3) Does not reside in the United States;
    (4) Is younger than 18 years of age before the first day of the 
month of the claim service date;
    (5) Has elected hospice;
    (6) Is receiving dialysis only for any acute kidney injury (AKI);
    (7) Has a diagnosis of dementia at any point during the month of the 
claim service date or the preceding 12 months, as identified using the 
most recent dementia-related criteria at the time of beneficiary 
attribution, using the CMS-HCC (Hierarchical Condition Category) Risk 
Adjustment Model ICD-10-CM Mappings; or
    (8) Is residing in or receiving dialysis in a skilled nursing 
facility (SNF) or nursing facility.
    (c) Attribution services. (1) ESRD facility beneficiary attribution. 
To be attributed to an ESRD facility that is an ETC Participant for a 
month, an ESRD Beneficiary must not be excluded based on the criteria 
specified in paragraph (b) of this section and must have received renal 
dialysis services during the month from the ESRD facility. CMS does not 
attribute Pre-emptive LDT Beneficiaries to ESRD facilities.
    (i) An ESRD Beneficiary is attributed to the ESRD facility at which 
the

[[Page 966]]

ESRD Beneficiary received the plurality of his or her dialysis 
treatments in that month, other than renal dialysis services for AKI, as 
identified by claims with Type of Bill 072X, with claim service dates at 
the claim header through date during the month.
    (ii) If the ESRD Beneficiary receives an equal number of dialysis 
treatments from two or more ESRD facilities in a given month, CMS 
attributes the ESRD Beneficiary to the ESRD facility at which the 
beneficiary received the earliest dialysis treatment that month. If the 
ESRD Beneficiary receives an equal number of dialysis treatments from 
two or more ESRD facilities in a given month and the ESRD beneficiary 
received the earliest dialysis treatment that month from more than one 
ESRD facility, CMS attributes the beneficiary to one of the ESRD 
facilities that furnished the earliest dialysis treatment that month at 
random.
    (2) Managing Clinician beneficiary attribution. (i) An ESRD 
beneficiary who is not excluded based on the criteria in paragraph (b) 
of this section is attributed to a Managing Clinician who is an ETC 
Participant for a month if that Managing Clinician submitted an MCP 
claim for services furnished to the beneficiary, identified with CPT 
codes 90957, 90958, 90959, 90960, 90961, 90962, 90965, or 90966, with 
claim service dates at the claim line through date during the month.
    (A) If more than one Managing Clinician submits a claim for the MCP 
furnished to a single ESRD Beneficiary with a claim service date at the 
claim line during the month, the ESRD Beneficiary is attributed to the 
Managing Clinician associated with the earliest claim service date at 
the claim line through date during the month.
    (B) If more than one Managing Clinician submits a claim for the MCP 
furnished to a single ESRD Beneficiary with the same earliest claim 
service date at the claim line through date for the month, the ESRD 
Beneficiary is randomly attributed to one of these Managing Clinicians.
    (ii) A Pre-emptive LDT Beneficiary who is not excluded based on the 
criteria in paragraph (b) of this section is attributed to the Managing 
Clinician with whom the beneficiary has had the most claims between the 
start of the MY and the month in which the beneficiary received the 
transplant for all months between the start of the MY and the month of 
the transplant.
    (A) If no Managing Clinician has had the plurality of claims for a 
given Pre-emptive LDT Beneficiary such that multiple Managing Clinicians 
each had the same number of claims for that beneficiary during the MY, 
the Pre-emptive LDT Beneficiary is attributed to the Managing Clinician 
associated with the latest claim service date at the claim line through 
date during the MY up to and including the month of the transplant.
    (B) If no Managing Clinician had the plurality of claims for a given 
Pre-emptive LDT Beneficiary such that multiple Managing Clinicians each 
had the same number of services for that beneficiary during the MY, and 
more than one of those Managing Clinicians had the latest claim service 
date at the claim line through date during the MY up to and including 
the month of the transplant, the Pre-emptive LDT Beneficiary is randomly 
attributed to one of these Managing Clinicians.



Sec. 512.365  Performance assessment.

    (a) General. For each MY, CMS separately assesses the home dialysis 
rate and the transplant rate for each ETC Participant based on the 
population of ESRD Beneficiaries and, if applicable, Pre-emptive LDT 
Beneficiaries attributed to the ETC Participant under Sec. 512.360. 
Information used to calculate the home dialysis rate and the transplant 
rate includes Medicare claims data, Medicare administrative data, and 
data from the Scientific Registry of Transplant Recipients.
    (b) Home dialysis rate. CMS calculates the home dialysis rate for 
ESRD facilities and Managing Clinicians as follows.
    (1) Home dialysis rate for ESRD facilities. (i) The denominator is 
the total dialysis treatment beneficiary years for attributed ESRD 
Beneficiaries during the MY. Dialysis treatment beneficiary years 
included in the denominator are composed of those months during which an 
attributed ESRD Beneficiary received maintenance dialysis at home or in 
an ESRD facility, such that one

[[Page 967]]

beneficiary year is composed of 12 beneficiary months. Months during 
which attributed ESRD Beneficiaries received maintenance dialysis are 
identified by claims with Type of Bill 072X.
    (ii) The numerator is the total number of home dialysis treatment 
beneficiary years plus one half the total number of self dialysis 
treatment beneficiary years for attributed ESRD Beneficiaries during the 
MY.
    (A) Home dialysis treatment beneficiary years included in the 
numerator are composed of those months during which attributed ESRD 
Beneficiaries received maintenance dialysis at home, such that one 
beneficiary year is comprised of 12 beneficiary months. Months in which 
an attributed ESRD Beneficiary received maintenance dialysis at home are 
identified by claims with Type of Bill 072X and condition codes 74 or 
76.
    (B) Self dialysis treatment beneficiary years included in the 
numerator are composed of those months during which attributed ESRD 
Beneficiaries received self dialysis in center, such that one 
beneficiary year is comprised of 12 beneficiary months. Months in which 
an attributed ESRD Beneficiary received self dialysis are identified by 
claims with Type of Bill 072X and condition code 72.
    (iii) Information used to calculate the ESRD facility home dialysis 
rate includes Medicare claims data and Medicare administrative data.
    (iv) The ESRD facility home dialysis rate is aggregated, as 
described in paragraph (e)(1) of this section.
    (2) Home dialysis rate for Managing Clinicians. (i) The denominator 
is the total dialysis treatment beneficiary years for attributed ESRD 
Beneficiaries during the MY. Dialysis treatment beneficiary years 
included in the denominator are composed of those months during which an 
attributed ESRD Beneficiary received maintenance dialysis at home or in 
an ESRD facility, such that one beneficiary year is comprised of 12 
beneficiary months. Months during which an attributed ESRD Beneficiary 
received maintenance dialysis are identified by claims with CPT codes 
90957, 90958, 90959, 90960, 90961, 90962, 90965, or 90966.
    (ii) The numerator is the total number of home dialysis treatment 
beneficiary years for attributed ESRD Beneficiaries during the MY plus 
one half the total number of self dialysis treatment beneficiary years.
    (A) Home dialysis treatment beneficiary years included in the 
numerator are composed of those months during which an attributed ESRD 
Beneficiary received maintenance dialysis at home, such that one 
beneficiary year is comprised of 12 beneficiary months. Months in which 
an attributed ESRD Beneficiary received maintenance dialysis at home are 
identified by claims with CPT codes 90965 or 90966.
    (B) Self-dialysis treatment beneficiary years included in the 
numerator are composed of those months during which an attributed ESRD 
Beneficiary received self dialysis in center, such that one beneficiary 
year is comprised of 12 beneficiary months. Months in which an 
attributed ESRD Beneficiary received self dialysis are identified by 
claims with Type of Bill 072X and condition code 72.
    (iii) Information used to calculate the Managing Clinician home 
dialysis rate includes Medicare claims data and Medicare administrative 
data.
    (iv) The Managing Clinician home dialysis rate is aggregated, as 
described in paragraph (e)(2) of this section.
    (c) Transplant rate. CMS calculates the transplant rate for ETC 
Participants as follows.
    (1) Transplant rate for ESRD facilities. The transplant rate for 
ESRD facilities is the sum of the transplant waitlist rate for ESRD 
facilities, as described in paragraph (c)(1)(i) of this section, and the 
living donor transplant rate for ESRD facilities, as described in 
paragraph (c)(1)(ii) of this section.
    (i) Transplant waitlist rate for ESRD facilities. (A) The 
denominator is the total dialysis treatment beneficiary years for 
attributed ESRD Beneficiaries during the MY. Dialysis treatment 
beneficiary years included in the denominator are composed of those 
months during which an attributed ESRD beneficiary received maintenance 
dialysis at home or in an ESRD facility, such that one beneficiary year 
is comprised of 12 beneficiary months. Months during which an attributed

[[Page 968]]

ESRD Beneficiary received maintenance dialysis are identified by claims 
with Type of Bill 072X, excluding claims for beneficiaries who were 75 
years of age or older at any point during the month.
    (B) The numerator is the total number of attributed beneficiary 
years for which attributed ESRD Beneficiaries were on the kidney 
transplant waitlist. Months during which an attributed ESRD Beneficiary 
was on the kidney transplant waitlist are identified using data from the 
SRTR database.
    (ii) Living donor transplant rate for ESRD facilities. (A) The 
denominator is the total dialysis treatment beneficiary years for 
attributed ESRD Beneficiaries during the MY. Dialysis treatment 
beneficiary years included in the denominator are composed of those 
months during which an attributed ESRD Beneficiary received maintenance 
dialysis at home or in an ESRD facility, such that one beneficiary year 
is comprised of 12 beneficiary months. Months during which an attributed 
ESRD Beneficiary received maintenance dialysis are identified by claims 
with Type of Bill 072X, excluding claims for beneficiaries who were 75 
years of age or older at any point during the month.
    (B) The numerator is the total number of attributed beneficiary 
years for LDT Beneficiaries during the MY. Beneficiary years for LDT 
Beneficiaries included in the numerator are composed of those months 
between the beginning of the MY up to and including the month of the 
transplant for LDT Beneficiaries attributed to an ESRD facility during 
the month of the transplant. LDT Beneficiaries are identified using 
information about living donor transplants from the SRTR Database and 
Medicare claims data.
    (iii) The ESRD facility transplant waitlist rate is risk adjusted, 
as described in paragraph (d) of this section. The ESRD facility 
transplant rate is aggregated, as described in paragraph (e)(1) of this 
section.
    (2) Transplant rate for Managing Clinicians. The transplant rate for 
Managing Clinicians is the sum of the transplant waitlist rate for 
Managing Clinicians, as described in paragraph (c)(2)(i) of this 
section, and the living donor transplant rate for Managing Clinicians, 
as described in paragraph (c)(2)(ii) of this section.
    (i) Transplant waitlist rate for Managing Clinicians. (A) The 
denominator is the total dialysis treatment beneficiary years for 
attributed ESRD Beneficiaries during the MY. Dialysis treatment 
beneficiary years included in the denominator are composed of those 
months during which an attributed ESRD Beneficiary received maintenance 
dialysis at home or in an ESRD facility, such that one beneficiary year 
is comprised of 12 beneficiary months. Months during which an attributed 
ESRD Beneficiary received maintenance dialysis are identified by claims 
with CPT codes 90957, 90958, 90959, 90960, 90961, 90962, 90965, or 
90966, excluding claims for beneficiaries who were 75 years of age or 
older at any point during the month.
    (B) The numerator is the total number of attributed beneficiary 
years for which attributed ESRD Beneficiaries were on the kidney 
transplant waitlist. Months during which an attributed ESRD Beneficiary 
was on the kidney transplant waitlist are identified using data from the 
SRTR database.
    (ii) Living donor transplant rate for Managing Clinicians. (A) The 
denominator is the sum of the total dialysis treatment beneficiary years 
for attributed ESRD Beneficiaries during the MY and the total Pre-
emptive LDT beneficiary years for attributed beneficiaries during the 
MY.
    (1) Dialysis treatment beneficiary years included in the denominator 
are composed of those months during which an attributed ESRD Beneficiary 
received maintenance dialysis at home or in an ESRD facility, such that 
one beneficiary year is comprised of 12 beneficiary months. Months 
during which an attributed ESRD Beneficiary received maintenance 
dialysis are identified by claims with CPT codes 90957, 90958, 90959, 
90960, 90961, 90962, 90965, or 90966, excluding claims for beneficiaries 
who were 75 years of age or older at any point during the month.
    (2) Pre-emptive LDT beneficiary years included in the denominator 
are composed of those months during which a Pre-emptive LDT Beneficiary 
is attributed to a Managing Clinician,

[[Page 969]]

from the beginning of the MY up to and including the month of the living 
donor transplant. Pre-emptive LDT Beneficiaries are identified using 
information about living donor transplants from the SRTR Database and 
Medicare claims data.
    (B) The numerator is the sum of the total number of attributed 
beneficiary years for LDT Beneficiaries during the MY and the total 
number of attributed beneficiary years for Pre-emptive LDT Beneficiaries 
during the MY.
    (1) Beneficiary years for LDT Beneficiaries included in the 
numerator are composed of those months during which an LDT Beneficiary 
is attributed to a Managing Clinician, from the beginning of the MY up 
to and including the month of the transplant. LDT Beneficiaries are 
identified using information about living donor transplants from the 
SRTR Database and Medicare claims data.
    (2) Beneficiary years for Pre-emptive LDT Beneficiaries included in 
the numerator are composed of those months during which a Pre-emptive 
LDT Beneficiary is attributed to a Managing Clinician, from the 
beginning of the MY up to and including the month of the transplant. 
Pre-emptive LDT Beneficiaries are identified using information about 
living donor transplants from the SRTR Database and Medicare claims 
data.
    (iii) The Managing Clinician transplant waitlist rate is risk 
adjusted, as described in paragraph (d) of this section. The Managing 
Clinician transplant rate is aggregated, as described in paragraph 
(e)(2) of this section.
    (d) Risk adjustment. (1) CMS risk adjusts the transplant waitlist 
rate based on beneficiary age with separate risk coefficients for the 
following age categories of beneficiaries, with age computed on the last 
day of each month of the MY:
    (i) 18 to 55.
    (ii) 56 to 70.
    (iii) 71 to 74.
    (2) CMS risk adjusts the transplant waitlist rate to account for the 
relative percentage of the population of beneficiaries attributed to the 
ETC Participant in each age category relative to the national age 
distribution of beneficiaries not excluded from attribution.
    (e) Aggregation. (1) Aggregation for ESRD facilities. An ESRD 
facility's home dialysis rate and transplant rate are aggregated to the 
ESRD facility's aggregation group. The aggregation group for a 
Subsidiary ESRD facility includes all ESRD facilities owned in whole or 
in part by the same legal entity located in the HRR in which the ESRD 
facility is located. An ESRD facility that is not a Subsidiary ESRD 
facility is not included in an aggregation group.
    (2) Aggregation for Managing Clinicians. A Managing Clinician's home 
dialysis rate and transplant rate are aggregated to the Managing 
Clinician's aggregation group. The aggregation group for a Managing 
Clinician who is--
    (i) In a group practice is the practice group level, as identified 
by practice TIN; or
    (ii) A solo practitioner is the individual clinician level, as 
identified by NPI.



Sec. 512.370  Benchmarking and scoring.

    (a) General. (1) CMS assesses the home dialysis rate and transplant 
rate for each ETC Participant against the applicable benchmarks to 
calculate an--
    (i) Achievement score, as described in paragraph (b) of this 
section; and
    (ii) Improvement score, as described in paragraph (c) of this 
section.
    (2)(i) CMS calculates the ETC Participant's MPS as the weighted sum 
of the higher of the achievement score or the improvement score for the 
ETC Participant's home dialysis rate and transplant rate, as described 
in paragraph (d) of this section.
    (ii) The ETC Participant's MPS determines the ETC Participant's PPA, 
as described in Sec. 512.380.
    (b) Achievement scoring. CMS assesses ETC Participant performance at 
the aggregation group level on the home dialysis rate and transplant 
rate against benchmarks constructed based on the home dialysis rate and 
transplant rate among aggregation groups of ESRD facilities and Managing 
Clinicians located in Comparison Geographic Areas during the Benchmark 
Year. CMS uses the following scoring

[[Page 970]]

methodology to assess an ETC Participant's achievement score.
    (1) 90th+ Percentile of benchmark rates for comparison geographic 
areas during the benchmark year: 2 points.
    (2) 75th+ Percentile of benchmark rates for comparison geographic 
areas during the benchmark year: 1.5 points.
    (3) 50th+ Percentile of benchmark rates for comparison geographic 
areas during the benchmark year: 1 point.
    (4) 30th+ Percentile of benchmark rates for comparison geographic 
areas during the benchmark year: 0.5 points.
    (5) <30th Percentile of benchmark rates for comparison geographic 
areas during the benchmark year: 0 points.
    (c) Improvement scoring. CMS assesses ETC Participant improvement on 
the home dialysis rate and transplant rate against benchmarks 
constructed based on the ETC Participant's aggregation group's 
historical performance on the home dialysis rate and transplant rate 
during the Benchmark Year. CMS uses the following scoring methodology to 
assess an ETC Participant's improvement score.
    (1) Greater than 10 percent improvement relative to the Benchmark 
Year rate: 1.5 points.
    (2) Greater than 5 percent improvement relative to the Benchmark 
Year rate: 1 point.
    (3) Greater than 0 percent improvement relative to the Benchmark 
Year rate: 0.5 points.
    (4) Less than or equal to the Benchmark Year rate: 0 points.
    (d) Modality Performance Score. CMS calculates the ETC Participant's 
MPS as the higher of ETC Participant's achievement score or improvement 
score for the home dialysis rate, together with the higher of the ETC 
Participant's achievement score or improvement score for the transplant 
rate, weighted such that the ETC Participant's score for the home 
dialysis rate constitutes \2/3\ of the MPS and the ETC Participant's 
score for the transplant rate constitutes \1/3\ of the MPS. CMS uses the 
following formula to calculate the ETC Participant's MPS:

Modality Performance Score = 2 x (Higher of the home dialysis 
achievement or improvement score) + (Higher of the transplant 
achievement or improvement score)



Sec. 512.375  Payments subject to adjustment.

    (a) Facility PPA. CMS adjusts the Adjusted ESRD PPS per Treatment 
Base Rate by the Facility PPA on claim lines with Type of Bill 072X, 
when the claim is submitted by an ETC Participant that is an ESRD 
facility and the beneficiary is at least 18 years old before the first 
day of the month, on claims with claim service dates during the 
applicable PPA Period as described in Sec. 512.355(c).
    (b) Clinician PPA. CMS adjusts the amount otherwise paid under 
Medicare Part B with respect to MCP claims on claim lines with CPT codes 
90957, 90958, 90959, 90960, 90961, 90962, 90965 and 90966 by the 
Clinician PPA when the claim is submitted by an ETC Participant who is a 
Managing Clinician and the beneficiary is at least 18 years old before 
the first day of the month, on claims with claim service dates during 
the applicable PPA Period as described in Sec. 512.355(c).



Sec. 512.380  PPA Amounts and schedules.

    CMS adjusts the payments described in Sec. 512.375 based on the ETC 
Participant's MPS calculated as described in Sec. 512.370(d) according 
to the following amounts and schedules in Table 1 and Table 2 to Sec. 
512.380.

[[Page 971]]

[GRAPHIC] [TIFF OMITTED] TR29SE20.031



Sec. 512.385  PPA exclusions.

    (a) ESRD facilities. CMS excludes an aggregation group (as described 
in Sec. 512.365(e)(1) of Subsidiary ESRD facilities with fewer than 11 
attributed ESRD beneficiary years during an MY from the applicability of 
the Facility PPA for the corresponding PPA Period. CMS excludes ESRD 
facilities that are not Subsidiary ESRD facilities with fewer than 11 
attributed ESRD beneficiary years during an MY from the applicability of 
the Facility PPA for the corresponding PPA Period.
    (b) Managing Clinicians. CMS excludes an aggregation group (as 
described in Sec. 512.365(e)(2)) of Managing Clinicians with fewer than 
11 attributed ESRD beneficiary years during an MY from the applicability 
of the Clinician PPA for the corresponding PPA Period.



Sec. 512.390  Notification and targeted review.

    (a) Notification. CMS will notify each ETC Participant, in a form 
and manner determined by CMS, of the ETC Participant's attributed 
beneficiaries, MPS, and PPA for a PPA Period no later than one month 
before the start of the applicable PPA Period.
    (b) Targeted review process. An ETC Participant may request a 
targeted review of the calculation of the MPS. Requests for targeted 
review are limited to the calculation of the MPS, and may not be 
submitted in regards to: The methodology used to determine the MPS; or 
the establishment of the home dialysis rate methodology, transplant rate 
methodology, achievement and improvement benchmarks and benchmarking 
methodology, or PPA amounts. The process for targeted reviews is as 
follows:
    (1) An ETC Participant has 90 days (or a later date specified by 
CMS) to submit a request for a targeted review, which begins on the day 
CMS makes available the MPS.
    (2) CMS will respond to each request for targeted review timely 
submitted and determine whether a targeted review is warranted.
    (3) The ETC Participant may include additional information in 
support of the request for targeted review at the time the request is 
submitted. If CMS requests additional information from the ETC 
Participant, it must be provided and received within 30 days of the 
request. Non-responsiveness to the request for additional information 
may

[[Page 972]]

result in the closure of the targeted review request.
    (4) If, upon completion of a targeted review, CMS finds that there 
was an error in the calculation of the ETC Participant's MPS such that 
an incorrect PPA has been applied during the PPA period, CMS shall 
notify the ETC Participant and must resolve any resulting discrepancy in 
payment that arises from the application of an incorrect PPA in a time 
and manner determined by CMS.
    (5) Decisions based on targeted review are final, and there is no 
further review or appeal.

                           Quality Monitoring



Sec. 512.395  Quality measures.

    CMS collects data on these two quality measures for ESRD facilities 
that are ETC Participants to monitor for changes in quality outcomes. 
CMS conducts data collection and measure calculation using claims data 
and other Medicare administrative data, including enrollment data:
    (a) Standardized Mortality Ratio (SMR); NQF 0369.
    (b) Standardized Hospitalization Ratio (SHR); NQF 1463.

                        Medicare Program Waivers



Sec. 512.397  ETC Model Medicare program waivers.

    The following provisions are waived solely for purposes of testing 
the ETC Model.
    (a)(1) Medicare payment waivers. CMS waives the requirements of 
sections 1833(a), 1833(b), 1848(a)(1), 1881(b), and 1881(h)(1)(A) of the 
Act only to the extent necessary to make the payment adjustments under 
the ETC Model described in this subpart.
    (2) Beneficiary cost sharing. The payment adjustments under the ETC 
Model described in this subpart do not affect the beneficiary cost-
sharing amounts for Part B services furnished by ETC Participants under 
the ETC Model.
    (b) CMS waives the following requirements of title XVIII of the Act 
solely for purposes of testing the ETC Model:
    (1) CMS waives the requirement under section 1861(ggg)(2)(A)(i) of 
the Act and Sec. 410.48(a) and (c)(2)(i) of this chapter that only 
doctors, physician assistants, nurse practitioners, and clinical nurse 
specialists can furnish KDE services to allow KDE services to be 
provided by clinical staff under the direction of and incident to the 
services of the Managing Clinician who is an ETC Participant. The KDE 
benefit must be furnished and billed by a Physician, clinical nurse 
specialist, licensed social worker, nurse practitioner, physician 
assistant, registered dietician/nutrition professional, or a clinic/
group practice.
    (2) CMS waives the requirement that the KDE is covered only for 
Stage IV chronic kidney disease (CKD) patients under section 
1861(ggg)(1)(A) of the Act and Sec. 410.48(b)(1) of this chapter to 
permit beneficiaries diagnosed with CKD Stage V or within the first 6 
months of starting dialysis to receive the KDE benefit.
    (3) CMS waives the requirement that the content of the KDE sessions 
include the management of co-morbidities, including delaying the need 
for dialysis, under Sec. 410.48(d)(1) of this chapter when such 
services are furnished to beneficiaries with CKD Stage V or ESRD, unless 
such content is relevant for the beneficiary.
    (4) CMS waives the requirement that an outcomes assessment designed 
to measure beneficiary knowledge about chronic kidney disease and its 
treatment be performed by a qualified clinician as part of one of the 
KDE sessions under Sec. 410.48(d)(5)(iii) of this chapter, provided 
that such outcomes assessment is performed within 1 month of the final 
KDE session by qualified staff.



PART 513_MOST FAVORED NATION (MFN) MODEL--Table of Contents



                      Subpart A_General Provisions

Sec.
513.1 Basis, scope, and duration.
513.2 Definitions.

                    Subpart B_Inclusion in the Model

513.100 MFN Model payments and MFN participants.
513.120 MFN Model geographic area.
513.130 MFN Model drugs, updates, categories and excluded drugs.
513.140 Included international data.

[[Page 973]]

                Subpart C_Payment Process and Methodology

513.200 Payment process and beneficiary cost-sharing.
513.210 Model payment methodology for MFN Model drugs.
513.220 Model alternative add-on payment.
513.230 Financial hardship exemptions, request process, and 
          reconciliation payment.

Subpart D [Reserved]

  Subpart E_Quality Strategy, Beneficiary Protections, and Compliance 
                               Activities

513.400 Quality measures.
513.410 Beneficiary protections.
513.420 Monitoring and compliance activities.
513.430 Audits and record retention.
513.440 Enforcement authority.
513.450 Limitations on review.

                            Subpart F_Waivers

513.500 Waivers of Medicare program requirements for purposes of testing 
          the MFN Model.

Subparts G-J [Reserved]

                       Subpart K_Model Termination

513.1000 Termination of the MFN Model.

    Authority: 42 U.S.C. 1302, 1315(a), and 1395hh.

    Source: 85 FR 76250, Nov. 27, 2010, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 513.1  Basis, scope, and duration.

    (a) Basis. This part implements the test of the Most Favored Nation 
(MFN) Model under section 1115A of the Act. Except as specifically noted 
in this part, the regulations under this part do not affect payment, 
coverage, program integrity, or any other requirements that otherwise 
apply to providers of services and suppliers under this chapter.
    (b) Scope. This part sets forth the following:
    (1) The types of providers and suppliers required to participate in 
the MFN Model and applicable requirements.
    (2) The beneficiaries included in the MFN Model.
    (3) The drugs included in the MFN Model.
    (4) The methodologies for establishing Medicare payment amounts for 
and making payments for MFN Model drugs, including an alternative add-on 
payment.
    (5) Beneficiary protections.
    (6) Beneficiary cost-sharing.
    (c) Duration. The MFN Model has a performance period of 7 
performance years. The first performance year (performance year 1) 
begins on January 1, 2021, and the final performance year ends on 
December 31, 2027, unless sooner terminated in accordance with Sec. 
513.1000.



Sec. 513.2  Definitions.

    For the purpose of this part the following definitions are 
applicable unless otherwise stated:
    Add-on percentage means the percentage above 100 percent.
    Alternative add-on payment means the payment described in Sec. 
513.220.
    Applicable ASP means the payment amount determined in accordance 
with section 1847A of the Act for a quarter minus the applicable add-on 
percentage.
    ASP stands for average sales price.
    ASP calendar quarter means the period that is two calendar quarters 
prior to the calendar quarter to which the MFN Drug Payment Amount will 
apply.
    CCN stands for CMS Certification Number.
    Country-level price means the unadjusted country-level price for an 
MFN Model drug at the HCPCS code level as calculated in accordance with 
Sec. 513.210(b)(2).
    CPI-U stands for Consumer Price Index for All Urban Consumers based 
on all items in U.S. city average and not seasonally adjusted.
    Days means calendar days.
    DME stands for Durable Medical Equipment.
    FDA stands for Food and Drug Administration.
    GDP stands for gross domestic product.
    GDP-adjusted country-level price means the country-level price 
adjusted by the GDP adjuster as calculated in accordance with Sec. 
513.210(b)(4).

[[Page 974]]

    GDP adjuster means the country-specific adjuster as calculated in 
accordance with Sec. 513.210(b)(3).
    HCPCS stands for Healthcare Common Procedure Coding System.
    HCPCS code level means the specified drug and amount described in 
the HCPCS code long descriptor.
    MAC stands for Medicare Administrative Contractor.
    Manufacturer's average sales price has the same meaning as under 42 
CFR Subpart J.
    MFN stands for most favored nation.
    MFN beneficiary means an individual who is furnished an MFN Model 
drug by an MFN participant and who, on the date of service, is enrolled 
in Medicare Part B, has Medicare as his or her primary payer, and is not 
covered under Medicare Advantage or any other group health plan, 
including a United Mine Workers of America health plan.
    MFN Drug Payment Amount means the portion of the total allowed 
payment amount for an MFN Model drug determined in accordance with Sec. 
513.210.
    MFN Model drug means a separately payable Medicare Part B drug or 
biological described by a HCPCS code included on the MFN Model Drug 
HCPCS Codes List.
    MFN Model Drug HCPCS Codes List means the list of drugs included in 
the MFN Model for a given calendar quarter of a performance year 
established under Sec. 513.130.
    MFN participant means a Medicare participating provider or supplier, 
identified by its CCN or TIN, that is required to participate in the MFN 
Model in accordance with Sec. 513.100(b).
    MFN Model Payment means the total payment to an MFN participant for 
an MFN Model drug in accordance with subpart C of this part, inclusive 
of the MFN Drug Payment Amount and the Alternative Add-on Payment.
    MFN Price means the lowest GDP-adjusted country-level price of the 
countries specified in Sec. 513.140(b) for an MFN Model drug.
    Model performance period means the 7-year period of time beginning 
on January 1, 2021, through December 31, 2027.
    NOC stands for not otherwise classified.
    OIG stands for the Department of Health and Human Services Office of 
Inspector General.
    Outpatient prospective payment system (OPPS) means the payment 
system for designated hospital outpatient items and services and certain 
Medicare Part B services furnished to hospital inpatients when Part A 
payment cannot be made as defined by section 1833(t) of the Act.
    Performance year means each 12-month period beginning on January 1 
and ending on December 31 during the performance period for the MFN 
Model specified in Sec. 513.1(c).
    Provider means a ``provider of services'' as defined under section 
1861(u) of the Act and codified at Sec. 400.202 of this chapter.
    Supplier means a supplier as defined in section 1861(d) of the Act 
and codified at Sec. 400.202 of this chapter.
    TIN stands for taxpayer identification number.
    WAC means wholesale acquisition cost as defined at section 
1847A(c)(6)(B) of the Act.



                    Subpart B_Inclusion in the Model



Sec. 513.100  MFN Model payments and MFN participants.

    (a) General. Subject to the exceptions specified in paragraph (d) of 
this section, the MFN Model payments specified under this part apply 
only to claims for an MFN Model drug furnished to an MFN beneficiary by 
an MFN participant.
    (b) MFN participants. Subject to the exclusions specified in 
paragraph (c) of this section, the MFN Model requires participation by 
each Medicare participating provider and supplier that submits a claim 
(except for claims specified in paragraph (d) of this section) for a 
separately payable drug that is an MFN Model drug furnished to an MFN 
beneficiary.
    (c) Excluded providers and suppliers. The following are excluded 
from participation in the MFN Model:
    (1) Children's hospitals (defined under section 1886(d)(1)(B)(iii) 
of the Act).
    (2) PPS-exempt cancer hospitals (defined under section 
1886(d)(1)(B)(v) of the Act).

[[Page 975]]

    (3) Critical access hospitals (CAHs) (defined under section 1820 of 
the Act).
    (4) Indian Health Service (IHS) facilities (as described in section 
1880 of the Act)), except when MFN Model drugs are furnished and such 
service is described in section 1880(e)(2)(B) of the Act.
    (5) Federally Qualified Health Centers (FQHCs) (defined under 
section 1861(aa)(4) of the Act).
    (6) Rural Health Clinics (RHCs) (defined under section 1861(aa)(2) 
of the Act).
    (7) Hospitals that are not subsection (d) hospitals (as defined in 
section 1886(d)(1)(B) of the Act) and are paid on the basis of 
reasonable costs subject to a ceiling under section 1886(b) of the Act.
    (8) Extended neoplastic disease care hospitals (defined in section 
1886(d)(1)(B)(vi) of the Act).
    (9) For the first quarter and second quarter of performance year 1, 
acute care hospitals that participate in any model authorized under 
section 1115A of Act for which payment for outpatient hospital services 
furnished to Medicare FFS beneficiaries, including MFN Model drugs, is 
made under such model on a fully capitated or global budget basis under 
a waiver of section 1833(t) of the Act.
    (10) Beginning with the third quarter of performance year 1, acute 
care hospitals that participate in any model authorized under section 
1115A of Act for which payment for outpatient hospital services 
furnished to Medicare FFS beneficiaries, including MFN Model drugs, is 
made under such model on a fully capitated or global budget basis under 
a waiver of section 1833(t) of the Act, where the parameters of such 
model adjust for the difference in payment for MFN Model drugs between 
the MFN Model and non-MFN Model drug payments such that savings under 
the MFN Model are incorporated into the other CMS Innovation Center 
model's parameters (for example, the annual global budget) for the 
duration of the MFN Model.
    (d) Exceptions. The MFN Model payments specified under this part do 
not apply to any of the following:
    (1) Claims for MFN Model drugs furnished in the inpatient hospital 
setting under those circumstances where Part A would not pay for 
hospital services.
    (2) Claims for MFN Model drugs administered during an inpatient 
hospital stay or included on an inpatient hospital claim.
    (3) Claims administered by the DME MACs as described in Sec. 
421.404(c)(2) of this chapter.
    (4) Claims paid under the End-Stage Renal Disease Prospective 
Payment System, including claims paid using the transitional drug add-on 
payment adjustment.
    (e) MFN participant requirements during the MFN Model. During the 
model performance period described in Sec. 513.1(c), MFN participants 
must do all of the following:
    (1) Adhere to the beneficiary protections requirements under Sec. 
513.410.
    (2) Adhere to the MFN Model-specific billing instructions 
requirements established by CMS and the MAC responsible for processing 
the MFN participant's claims, including without limitation those 
described in Sec. 513.200.
    (3) Participate in MFN Model monitoring and evaluation activities in 
accordance with Sec. 403.1110(b) of this chapter, including collecting 
and reporting information as the Secretary determines is necessary to 
monitor and evaluate the MFN Model, including without limitation 
``protected health information'' as that term is defined at 45 CFR 
160.103.
    (f) MFN participant requirements after the MFN Model. For 2 years 
after termination of the MFN Model, MFN participants must participate in 
MFN Model monitoring activities as described in Sec. 513.420.



Sec. 513.120  MFN Model geographic area.

    The MFN Model geographic area is all states and U.S. territories.



Sec. 513.130  MFN Model drugs, updates, categories and excluded drugs.

    (a) MFN Model drugs. CMS creates and periodically updates the MFN 
Model Drug HCPCS Codes List as described in this section. The MFN Model 
Drug HCPCS Codes List designates the MFN Model drugs, which are subject 
to the MFN Model payments specified in subpart C of this part.

[[Page 976]]

    (1) Initial MFN Model Drug HCPCS Codes List. For the beginning of 
performance year 1, CMS identifies the top 50 drugs by HCPCS code with 
the highest aggregate 2019 Medicare Part B total allowed charges after 
making the exclusions specified in paragraphs (b)(1) and (b)(2) of this 
section, and adds the remaining HCPCS codes, after updating such HCPCS 
codes for any applicable changes, to the MFN Model Drug HCPCS Codes 
List. Final action claims with dates of service within calendar year 
2019 and allowed charges greater than $0 are used to determine aggregate 
2019 Medicare Part B total allowed charges.
    (2) Annual Update of the MFN Model Drug HCPCS Codes List. For the 
start of each subsequent performance year, using Medicare Part B total 
allowed charge from the next subsequent calendar year, CMS identifies 
the top 50 drugs by HCPCS code with the highest aggregate Medicare Part 
B total allowed charges, after making the exclusions specified in 
paragraphs (b)(1) and (b)(2) of this section, for the most recent full 
calendar year, and adds any remaining HCPCS codes not already on the MFN 
Model Drug HCPCS Codes List to the MFN Model Drug HCPCS Codes List, 
after updating such HCPCS codes for any applicable changes, effective on 
the first day of the performance year.
    (3) Removal. No more frequently than quarterly, CMS removes HCPCS 
codes from the MFN Model Drug HCPCS Codes List when CMS becomes aware 
that all of the National Drug Codes assigned to the HCPCS code have been 
permanently withdrawn from the U.S. market and the drug has been 
permanently withdrawn from the U.S. market, the specific HCPCS code 
included on the MFN Model Drug HCPCS Codes List is terminated with no 
replacement code available or planned, or an exclusion in paragraph 
(b)(1) of this section applies.
    (4) Maintenance. No more frequently than quarterly, CMS revises 
HCPCS codes on the MFN Model Drug HCPCS Codes List as necessary to 
reflect quarterly HCPCS code updates that are applicable to the HCPCS 
codes on the MFN Model Drug HCPCS Codes List, including adding 
replacement codes for HCPCS codes that were terminated.
    (b) Exclusions. (1) The following are excluded from the MFN Model:
    (i) Vaccines specified in section 1861(s)(10) of the Act (influenza, 
pneumococcal pneumonia, coronavirus disease 2019 (COVID-19), and 
Hepatitis B vaccines).
    (ii) Radiopharmaceuticals.
    (iii) Oral anticancer chemotherapeutic agents described in section 
1861(s)(2)(Q) of the Act.
    (iv) Oral anti-emetic drugs described in 1861(s)(2)(T) of the Act.
    (v) Oral immunosuppressive drugs described in section 1861(s)(2)(J) 
of the Act.
    (vi) Compounded drugs.
    (vii) Intravenous immune globulin products.
    (viii) Drugs billed with HCPCS codes that describe a drug product 
that was approved under an abbreviated new drug application under 
section 505(j) of the Federal Food, Drug, and Cosmetic Act;
    (ix) Drugs for which there is an Emergency Use Authorization (EUA) 
from FDA, or FDA approval, to treat patients with suspected or confirmed 
COVID-19; or
    (x) Drugs billed using a not otherwise classified (NOC) or not 
otherwise specified (NOS) billing and payment code.
    (2) The following claims are excluded from the determination of 
whether a drug is to be included on the MFN Model Drug HCPCS Codes List:
    (i) Professional claims with a place of service code indicating a 
home setting, including home, homeless shelter, assisted living 
facility, group home, temporary lodging, and custodial care facilities.
    (ii) Claims administered by the DME MACs as described in Sec. 
421.404(c)(2) of this chapter.



Sec. 513.140  Included international data.

    (a) General. (1) CMS uses drug pricing information from 
international data sources, available to CMS at least 20 business days 
prior to the start of a calendar quarter, meeting the requirements in 
paragraph (c) of this section for MFN Model drugs from countries 
included in paragraph (b) of this section.

[[Page 977]]

    (2) For purposes of selecting a data source for each MFN Model drug 
for a calendar quarter, CMS identifies available international drug 
pricing information data sources for the MFN Model drug, by aligning the 
MFN Model drug's HCPCS code long description (including dosage form) 
with the data sources' standardized method for identifying scientific 
names or nonproprietary names and dosage formulations, as applicable.
    (b) Non-U.S. member countries of the Organisation for Economic Co-
operation and Development (OECD). (1) CMS uses available international 
sales, volume, and pricing data for countries that were non-U.S. OECD 
member countries as of October 1, 2020 with a GDP per capita that is at 
least 60 percent of the U.S. GDP per capita as determined by CMS in 
accordance with this paragraph (b).
    (2) Each country's GDP per capita is assessed using data available 
at the end of the applicable ASP calendar quarter.
    (3) Subject to the limitation specified in paragraph (b)(4) of this 
section, the GDP per capita for a country is the the most recent 
estimate of GDP per capita based on purchasing power parity for that 
country available in the U.S. Central Intelligence Agency (CIA) World 
Factbook.
    (4) The country's GDP per capita and U.S. GDP per capita selected 
from the CIA World Factbook must be for the same year.
    (5) CMS identifies countries with a GDP per capita that is at least 
60 percent of the U.S. GDP per capita by dividing the GDP per capita for 
a country by the U.S. GDP per capita and assessing the results.
    (c) Identification of international data sources. (1) CMS obtains 
data from one or more international drug pricing information data 
sources for purposes of identifying available international drug pricing 
information for the countries specified in paragraph (b) of this 
section.
    (2) Such data sources must, as determined by CMS--
    (i) Utilize a standardized method for identifying drugs across 
countries within that data source, such as using internationally 
recognized scientific and nonproprietary product names;
    (ii) Utilize a standard method for identifying drug forms that at a 
minimum distinguishes among injectable, oral, and other forms of a drug; 
and
    (iii) Be maintained by an organization that seeks to limit the lag 
inherent in data to no more than 180 days from the end of the calendar 
quarter for which drug pricing information is compiled to the time that 
the organization makes such updates available to users of the database.
    (iv) Contains international drug pricing information stated in U.S. 
currency, such as the following:
    (A) Sales data, which may be based on ex-manufacturer prices 
(sometimes called ex-factory prices) that represent actual or calculated 
prices paid to the manufacturer by wholesalers and other distributors, 
or retail prices that represent actual or calculated sales for retail 
purchasers, or prices paid by other purchasers in the distribution 
channels.
    (B) Volume data (for example, number of packages or units sold).
    (C) List prices.
    (v) Have mechanisms in place to maintain, update, and correct, if 
necessary, the information on international drug pricing in the data 
source on at least a quarterly basis.
    (3) For each MFN Model drug for a calendar quarter, CMS selects a 
data source using the following hierarchy.
    (i) The data source contains sales and volume data for the 
applicable ASP calendar quarter from at least one country described in 
paragraph (b) of this section.
    (ii) The data source does not have sales and volume data for the 
applicable ASP calendar quarter, but contains sales and volume data for 
any prior ASP calendar quarter beginning on or after October 1, 2019 
from at least one country described in paragraph (b) of this section. If 
sales and volume data from a prior ASP calendar quarter are used, CMS 
uses sales and volume data from the most recent ASP calendar quarter for 
which both sales and volume data are available.
    (iii) The extracted data used by CMS to determine the most recent 
MFN Price used to calculate an MFN Drug

[[Page 978]]

Payment Amount posted on the MFN Model website.
    (iv) The data source contains ex-manufacturer price data for the 
applicable ASP calendar quarter from at least one country described in 
paragraph (b) of this section.
    (v) The data source contains list price data for the applicable ASP 
calendar quarter from at least one country described in paragraph (b) of 
this section.
    (vi) If there is more than one data source for an ASP calendar 
quarter, for each MFN Model drug, CMS selects the data source at the 
highest level of the hierarchy that contains information from the 
highest number of countries described in paragraph (b) of this section 
and, if available, incorporates discounts and rebates into its drug 
pricing information, and uses this data source to calculate the MFN 
Price as described in Sec. 513.210(b).



                Subpart C_Payment Process and Methodology



Sec. 513.200  Payment process and beneficiary cost-sharing.

    (a) General. For purposes of the MFN Model, the allowed MFN Drug 
Payment Amount does not exceed the billed amount on the claim for the 
MFN Model drug.
    (b) Model-specific billing instructions. MFN participants submit 
claims for MFN Model drugs to the applicable MAC in the form and manner 
specified by CMS in model-specific billing instructions.
    (c) Beneficiary cost-sharing. Beneficiary coinsurance does not apply 
to the portion of the allowed payment amount for an MFN Model drug that 
is determined under Sec. 513.220.



Sec. 513.210  Model payment methodology for MFN Model drugs.

    (a) Payment amount. The total allowed payment amount for an MFN 
Model drug furnished to an MFN beneficiary by an MFN participant on a 
given date of service within a calendar quarter is determined in 
accordance with this section. The total allowed payment equals--
    (1) For each billing unit in the HCPCS code descriptor of the MFN 
Model drug, the MFN Drug Payment Amount determined in accordance with 
paragraphs (b), (c) and (d) of this section, as applicable, where the 
allowed MFN Drug Payment Amount does not exceed the billed amount on the 
claim for the MFN Model drug as described in Sec. 513.200(a); and
    (2) The alternative add-on payment determined under Sec. 513.220.
    (b) Calculation of the MFN Drug Payment Amount with Available 
International Drug Pricing Data. CMS selects an available international 
drug pricing information data source described in Sec. 513.140(c) for 
at least one country specified in Sec. 513.140(b) for an MFN Model 
drug, and calculates, in advance of each calendar quarter for a 
performance year, the applicable MFN Drug Payment Amount for one billing 
unit of an MFN Model drug using the following steps:
    (1) Available international drug pricing data. (i) For the MFN Model 
drug, using the data source selected in accordance with Sec. 
513.140(c)(3) (except for a data source described in Sec. 
513.140(c)(3)(iii)), CMS identifies available international drug pricing 
data for the MFN Model drug, by aligning the MFN Model drug's HCPCS code 
long description (including dosage form) with the data sources' 
standardized method for identifying scientific names or nonproprietary 
names and dosage formulations, as applicable. CMS extracts available 
drug pricing data for the countries specified in Sec. 513.140(b) from 
the selected international drug pricing information data source. CMS 
uses the extracted data that have complete package size information and 
only for dosage formulations that could be described by the MFN Model 
drug's HCPCS code descriptor, as determined by CMS. If a data source 
described in Sec. 513.140(c)(3)(iii) is selected, CMS uses such 
extracted data.
    (ii) When international drug pricing data with sales and volume data 
are available, CMS excludes from the calculation of the unadjusted 
country-level price under paragraph (b)(2) of this section international 
drug pricing data without both sales and volume data, with less than 
$1,000 in quarterly sales (expressed as U.S. currency), or

[[Page 979]]

with less than 1,000 units in quarterly volume.
    (iii) CMS converts the extracted volume data to the MFN Model drug's 
HCPCS code billing unit level, as applicable.
    (iv) CMS adjusts the extracted volume data, as applicable, before 
converting the extracted volume data to the MFN Model drug's HCPCS code 
billing unit level when the data source shows the package size of a drug 
product that is inconsistent with the manufacturer's information about 
that product, as determined by CMS.
    (v) CMS limits the number of HCPCS code billing units when--
    (A) The package labeling indicates a limited amount of drug is to be 
used from the package; and
    (B) The HCPCS code dosage is per dose.
    (2) Calculate the unadjusted country-level price for the MFN Model 
drug by country.
    (i) Using the drug pricing data extracted and adjusted in accordance 
with paragraph (b)(1) of this section, CMS calculates the unadjusted 
country-level price for the MFN Model drug by country, using the 
calculation that is applicable.
    (ii) If an international drug pricing information data source with 
sales and volume data is used, the applicable calculation is as follows:
    (A) CMS sums the adjusted volume data (as specified in paragraph 
(b)(1)(iii) of this section) for the drug.
    (B) CMS sums the total sales for the drug (that remain after 
performing the exclusions in paragraph (b)(1)(ii) of this section).
    (C) CMS divides the sum determined in paragraph (b)(2)(ii)(B) of the 
section by the sum determined in paragraph (b)(2)(ii)(A) of this 
section, resulting in an average price per unit of drug, where the unit 
of drug is the same as the HCPCS code billing unit.
    (iii) If an international drug pricing information data source with 
ex-manufacturer or list prices is used, the applicable calculation is as 
follows:
    (A) For each extracted ex-manufacturer or list price, CMS calculates 
the number of HCPCS billing units in the package by dividing the amount 
of drug in the package by the amount of drug represented in one HCPCS 
billing unit.
    (B) CMS divides the ex-manufacturer or list price, as applicable, by 
the number of HCPCS billing units in the package, resulting in a price 
per unit of drug where the unit of drug is the same as the HCPCS code 
billing unit.
    (C) CMS sums the price per unit of drug calculated in paragraph 
(c)(3)(iii)(B) of this section.
    (D) CMS divides the sum calculated in paragraph (c)(3)(iii)(C) of 
this section by the number of ex-manufacturer or list prices that were 
summed in paragraph (c)(3)(iii)(C) of this section, resulting in an 
average price per unit of drug where the unit of drug is the same as the 
HCPCS code billing unit.
    (iv) CMS performs the applicable calculation for each country 
specified in Sec. 513.140(b) for which international drug pricing 
information is available in the selected data source.
    (3) Calculate the GDP adjuster for each country. (i) CMS calculates 
the GDP adjuster by dividing the country's GDP per capita by the U.S. 
GDP per capita for the same year.
    (ii) In cases where the resulting ratio exceeds 1.0, the GDP 
adjuster is set to 1.0.
    (iii) Subject to the limitations specified in paragraph (b)(3)(iv) 
of this section, the GDP per capita for a country is the most recent 
estimate of GDP per capita based on purchasing power parity for that 
country available in the CIA World Factbook at the end of the applicable 
ASP calendar quarter.
    (iv) Limitations. (A) The country's GDP per capita and U.S. GDP per 
capita must be for the same year.
    (B) The GDP per capita used must be for the same year as the data 
used to calculate the unadjusted country-level price, if available, or 
the most recent earlier year available.
    (4) Apply the GDP adjuster to calculate the GDP-adjusted country-
level price. CMS applies the applicable GDP adjuster identified in 
paragraph (b)(3) of this section to each unadjusted country-level price 
identified in paragraph (b)(2) of this section to calculate the GDP-
adjusted country-level price by dividing each unadjusted country-level 
price by the applicable GDP adjuster.

[[Page 980]]

    (5) Identify the lowest GDP-adjusted country-level price. CMS 
identifies the lowest GDP-adjusted country-level price for the MFN Model 
drug. Except as provided in paragraph (b)(7) of this section, the price 
identified is the MFN Model drug's MFN Price.
    (6) Identify Applicable ASP. CMS identifies the applicable ASP for 
the applicable quarter.
    (7) Compare the MFN Price to the applicable ASP. CMS compares the 
price determined in paragraph (b)(5) of this section to the applicable 
ASP identified in paragraph (b)(6) of this section. The MFN Price equals 
the applicable ASP if the applicable ASP is less than the price 
determined in paragraph (b)(5) of this section.
    (8) Phase-in. CMS identifies the applicable phase-in formula based 
on the applicable performance year as follows:
    (i) Performance year 1: 75 percent applicable ASP and 25 percent MFN 
Price.
    (ii) Performance year 2: 50 percent applicable ASP and 50 percent 
MFN Price.
    (iii) Performance year 3: 25 percent applicable ASP and 75 percent 
MFN Price.
    (iv) Performance year 4: 100 percent MFN Price.
    (v) Performance year 5: 100 percent MFN Price.
    (vi) Performance year 6: 100 percent MFN Price.
    (vii) Performance year 7: 100 percent MFN Price.
    (9) Final calculation steps. (i) CMS applies the applicable phase-in 
formula to the applicable ASP and the MFN Price. Subject to any 
applicable adjustments as provided in paragraph (d) of this section, the 
amount determined in this paragraph is the MFN Drug Payment Amount.
    (ii) Subject to the limitation in paragraph (b)(iii) in this 
section, CMS recalculates the MFN Drug Payment Amounts for prior 
quarters when revised international drug pricing information is 
available in the data source that was used to calculate the MFN Price 
and applicable ASP updates are available from CMS. CMS prospectively 
applies the recalculations in the quarterly update following the 
availability of revised international drug pricing information and ASP 
updates.
    (iii) MFN Drug Payment Amounts may be recalculated for the prior 
four calendar quarters of the model.
    (c) Frequency of MFN Drug Payment Amount updates. CMS updates the 
MFN Drug Payment Amounts on a calendar quarter basis. CMS publishes the 
quarterly MFN Drug Payment Amounts on the MFN Model website in advance 
of the calendar quarter in which the MFN Drug Payment Amounts apply, 
along with any recalculated MFN Drug Payment Amounts for prior quarters.
    (d) Exceptions. (1) Payment for MFN Model drugs for which no 
international drug pricing data are available. If, as of the first 
calendar quarter during which an MFN Model drug has been included in the 
MFN Model Drug HCPCS Codes List in accordance with Sec. 513.130, no 
international sales, volume or pricing information meeting the 
requirements described in Sec. 513.140(c)--including data used by CMS 
to determine the most recent MFN Price used to calculate an MFN Drug 
Payment Amount posted on the MFN Model website--is available from any 
country described in Sec. 513.120(b) for any calendar quarter beginning 
on or after October 1, 2019 through the applicable quarter, the MFN Drug 
Payment Amount is the applicable ASP.
    (2) Payment for MFN Model drugs that are in short supply. If an MFN 
Model drug is reported as ``Currently in Shortage'' by FDA, beginning 
with the first day of the next calendar quarter after the date on which 
it is reported in shortage, the MFN Drug Payment Amount is the 
applicable ASP. CMS calculates payment in accordance with paragraph (b) 
of this section as of the first day of the calendar quarter after the 
date upon which the drug is no longer reported as ``Currently in 
Shortage'' by FDA.
    (3) Adjustment to phase-in formula. (i) CMS accelerates the phase-in 
of the MFN Price by 5 percentage points at the next quarterly update to 
calculate the MFN Drug Payment Amount for the MFN Model drug where both 
of the following conditions are met:
    (A) There is a greater cumulative percentage increase in either the 
applicable ASP or any of the monthly U.S.

[[Page 981]]

list prices for the NDCs assigned to the MFN Model drug's HCPCS code 
compared to the cumulative percentage increase in the CPI-U.
    (B) There is a greater cumulative percentage increase in either the 
applicable ASP or any of the monthly U.S. list prices for the NDCs 
assigned to the MFN Model drug's HCPCS code compared to the cumulative 
percentage increase in the MFN Price.
    (C) For purposes of paragraphs (d)(3)(i)(A) and (B) of this section, 
the cumulative percentage increase means the cumulative percentage 
change from the end of the baseline to the end of the applicable ASP 
calendar quarter.
    (D) The baseline in paragraph (d)(3)(i)(C) of this section for an 
MFN Model drug is the ASP calendar quarter for the applicable ASP for 
the first quarter of performance year 1. If there is not an applicable 
ASP for the first quarter of performance year 1 for an MFN Model drug, 
the baseline for that MFN Model drug is the ASP calendar quarter for the 
first applicable ASP based on the manufacturer's average sales price for 
that MFN Model drug that occurs after the ASP calendar quarter for the 
applicable ASP for the first quarter of performance year 1.
    (ii) For purposes of paragraph (d)(3)(i) of this section, if the 
cumulative percentage increase in CPI-U or MFN Price is negative, CMS 
uses zero as the cumulative percentage increase in CPI-U or MFN Price, 
as applicable.
    (iii) The application of an acceleration of the phase-in formula 
continues for the duration of the model performance period.
    (iv) CMS applies an additional acceleration of the phase-in formula 
for each calendar quarter where the conditions specified in paragraph 
(i) are met.
    (4) Adjustment for rapid increases in the applicable ASP or any 
monthly U.S. list prices beyond inflation and MFN Price after the full 
phase-in of the MFN Price. If the conditions described in paragraphs 
(d)(3)(i)(A) and (B) of this section are met after the full phase-in of 
the MFN Price for an MFN Model drug, for each calendar quarter 
thereafter, CMS decreases the MFN Drug Payment Amount equal to largest 
difference in the cumulative percentage increase in the applicable ASP 
or any of the monthly U.S. list prices for the NDCs assigned to the MFN 
Model drug's HCPCS code compared to the cumulative percentage increase 
in the CPI-U and in the MFN Price, respectively, determined quarterly.
    (5) Limitation on MFN Drug Payment Amount. The MFN Drug Payment 
Amount cannot exceed the non-model drug payment amount for claim lines 
submitted with the JG modifier (or any successor modifier used to 
identify drugs purchased under the 340B program) after removing any add-
on amount, if applicable.
    (e) Blood clotting factor furnishing fee. When applicable, the blood 
clotting furnishing fee under Sec. 410.63(c) of this chapter is payable 
along with the MFN Drug Payment Amount.



Sec. 513.220  Model alternative add-on payment.

    (a) Payment amount. (1) The total allowed alternative add-on payment 
amount for a separately payable dose of an MFN Model drug furnished to 
an MFN beneficiary by an MFN participant on a given date of service 
within a calendar quarter is determined in accordance with this section.
    (2) The total allowed alternative add-on payment amount for a claim 
line does not exceed the billed amount on that claim line.
    (b) Calculation of the per-dose alternative add-on payment amount. 
CMS calculates the per-dose alternative add-on payment for performance 
year 1, quarter 1 for MFN Model drugs using the following steps:
    (1) CMS identifies available Medicare Part B fee-for-service final 
action claims lines, with dates of service in 2019, for drugs on the 
initial MFN Model HCPCS Codes List described in Sec. 513.130(a)(1), 
excluding claims for providers and suppliers specified in Sec. 
513.100(c), and claims specified in Sec. 513.100(d), that were 
furnished by Medicare-participating providers and suppliers, have a 
separately paid allowed charge greater than $0, and for which Medicare 
Part B was the primary payer. If a HCPCS code on the initial MFN Model 
HCPCS Codes List was not in use during any calendar quarter in 2019, CMS 
uses the HCPCS

[[Page 982]]

code that was applicable for the MFN Model drug during 2019.
    (2) CMS identifies the applicable ASP for each calendar quarter of 
2019 for the drugs (by HCPCS code as specified in paragraph (b)(1) of 
this section) included on the initial MFN Model HCPCS Codes List. In the 
case of a biosimilar biological product, the applicable ASP for the 
reference biological product is identified and used in paragraph (b)(3) 
of this section.
    (3) CMS multiplies the number of units billed for each claim line 
described in paragraph (b)(1) of this section by 6.1224 percent of the 
applicable ASP identified in paragraph (b)(2) of this section for the 
HCPCS code on the claim line and date of service.
    (4) CMS sums the products calculated in paragraph (b)(3) of this 
section for all claim lines for each MFN Model drug to calculate the 
total add-on spending amount for each MFN Model drug.
    (5) CMS sums the amounts calculated in paragraph (b)(4) of this 
section to calculate the total pooled add-on spending amount for all MFN 
Model drugs.
    (6) CMS divides the amount calculated in paragraph (b)(5) of this 
section by the total number of claim lines retained in paragraph (b)(1) 
of this section, excluding claim lines billed with the JW modifier.
    (7) CMS trends the amount calculated in paragraph (b)(6) of this 
section forward to the applicable ASP calendar quarter for quarter 1 of 
performance year 1 using the percentage change in CPI-U from July 2019 
through October 2020.
    (c) Frequency of alternative add-on payment amount updates. For each 
calendar quarter after quarter 1 of performance year 1, CMS updates the 
alternative add-on payment by applying a cumulative inflation factor 
based on the cumulative percentage change in CPI-U from October 2020 
through the first month of the prior calendar quarter. If the cumulative 
percentage change in the CPI-U is negative, CMS uses an inflation factor 
of 1.
    (d) Limitation on the alternative add-on payment. The alternate add-
on payment is not payable for claim lines billed--
    (1) With the JW modifier; or
    (2) By MFN participants that receive an alternative add-on payment 
for an MFN Model drug under any other model authorized by section 1115A 
of the Act that tests an alternative approach to the add-on portion of 
payment for Medicare Part B drugs.



Sec. 513.230  Financial hardship exemptions, request process, 
and reconciliation payment.

    (a) General. For purposes of the MFN Model, a financial hardship 
exemption for a performance year may be granted to an MFN participant by 
CMS, in its sole discretion and not subject to appeal, when the 
provisions in this section are met.
    (b) Request for financial hardship exemption. To be eligible for a 
financial hardship exemption, the MFN participant must submit a request 
for financial hardship exemption in the form and manner and with the 
content specified by CMS, including without limitation the requirements 
of this paragraph (b).
    (1) Timing and form of request. The MFN participant must submit its 
request for a financial hardship exemption to CMS in accordance the 
submission process posted on the MFN Model website and such request must 
be submitted within 60 calendar days following the end of the 
performance year for which the MFN participant seeks a financial 
hardship exemption.
    (2) Request content. The MFN participant's request a financial 
hardship exemption must include, at a minimum, all of the following:
    (i) Evidence of methods used to obtain each MFN Model drug that was 
furnished by the MFN participant during the performance year to any 
patient.
    (ii) Average net acquisition cost for each MFN Model drug (inclusive 
of all on- and off-invoice discounts or adjustments, and any other price 
concessions related to the purchase of the MFN Model drug) that was 
furnished by the MFN participant during the performance year to MFN 
beneficiaries.
    (iii) Average net acquisition cost for each MFN Model drug 
(inclusive of all on- and off-invoice discounts and adjustments, and any 
other price concessions related to the purchase of the

[[Page 983]]

MFN Model drug) that was furnished by the MFN participant during the 
performance year to patients who were not MFN beneficiaries.
    (iv) Statement of any remuneration received by the MFN participant 
from manufacturers of MFN Model drugs, wholesalers, and distributors 
that is not reflected in the MFN participant's average net acquisition 
costs with a justification of why such remuneration should not be 
treated as a price concession related to the purchase of an MFN Model 
drug.
    (v) Administrative information, including: MFN participant's name, 
TIN or CCN (as applicable), contact name, phone number, and email 
address.
    (vi) The MFN participant's attestation that:
    (A) The MFN participant experienced a reduction in Medicare Part B 
FFS payments for separately payable drugs on a per beneficiary basis 
during the performance year as compared to the prior year (that is, the 
four calendar quarters immediately preceding the performance year) due 
to its inability to obtain one or more of the MFN Model drugs at or 
below the MFN Model Payments for such drugs during the performance year;
    (B) The MFN participant has not received and will not receive any 
remuneration from manufacturers of MFN Model drugs, wholesalers, and 
distributors related to the purchase of an MFN Model drug that was 
furnished by the MFN participant during the performance year that is not 
reflected in the MFN participant's submission; and
    (C) The MFN participant submission is true, accurate and complete.
    (c) Standard of review. (1) Incomplete requests for a financial 
hardship exemption, as determined by CMS, are not reviewed.
    (2) CMS grants a financial hardship exemption to an MFN participant 
for a performance year, if the agency in its sole discretion determines 
the following requirements have been met:
    (i) The MFN participant submits a timely, complete request for 
financial hardship exemption in accordance with the requirements of this 
section which in the sole discretion of CMS demonstrates all of the 
following:
    (A) The MFN participant exhausted all reasonable methods to obtain 
MFN Model drugs at or below the MFN Model Payment for such drugs during 
the performance year.
    (B) The MFN participant's average net acquisition cost for each MFN 
Model drug (including invoices and off-invoice discounts or adjustments) 
that was furnished by the MFN participant during the performance year to 
patients who were not MFN beneficiaries was not less than the MFN 
participant's average net acquisition costs for such MFN Model drug 
(including invoices and off-invoice discounts or adjustments) that was 
furnished by the MFN participant during the performance year to MFN 
beneficiaries.
    (C) Any remuneration the MFN participant received from manufacturers 
of MFN Model drugs, wholesalers, and distributors that was not reflected 
in the MFN participant's average net acquisition costs was not a price 
concession related to the purchase of an MFN Model drug.
    (ii) The MFN participant's excess reduction amount per beneficiary 
(as determined in paragraph (d)(6) of this section), is greater than 
zero.
    (d) Excess reduction amount per beneficiary. CMS calculates the MFN 
participant's excess reduction amount per beneficiary using available 
final action claims data where Medicare was the primary payer that is 
estimated to be more than 90 percent complete in accordance with the 
following steps:
    (1) CMS calculates, separately for dates of service within the 
performance year and prior year, the MFN participant's total allowed 
charges for separately payable Medicare Part B drugs, and the total 
number of beneficiaries that had at least one claim for a service 
furnished by the MFN participant with a Medicare Part A or Medicare Part 
B allowed charge greater than $0.
    (2) CMS divides the MFN participant's total allowed charges for 
separately payable Medicare Part B drugs for dates of service within the 
performance year by the total number of beneficiaries that had at least 
one claim for a service furnished by the MFN participant with a Medicare 
Part A or Medicare Part B allowed charge greater than $0 with a service 
date within the

[[Page 984]]

performance year, to calculate the MFN participant's average per 
beneficiary total allowed charges for separately payable Medicare Part B 
drugs for the performance year.
    (3) CMS divides the MFN participant's total allowed charges for 
separately payable Medicare Part B drugs for dates of service within the 
prior year by the total number of beneficiaries that had at least one 
claim for a service furnished by the MFN participant with a Medicare 
Part A or Medicare Part B allowed charge greater than $0 with a service 
date within the prior year, to calculate the MFN participant's average 
per beneficiary total allowed charges for separately payable Medicare 
Part B drugs for the prior year.
    (4) CMS subtracts the MFN participant's average per beneficiary 
total allowed charges for separately payable Medicare Part B drugs for 
the performance year (as calculated in paragraph (d)(2) of this section) 
from the MFN participant's average per beneficiary total allowed charges 
for separately payable Medicare Part B drugs for the prior year (as 
calculated in paragraph (d)(3) of this section).
    (5) CMS calculates 25 percent of the MFN participant's total allowed 
charges for all Medicare Part A and Part B claims with dates of service 
within the prior year and divides that amount by the total number of 
beneficiaries that had at least one claim for a service furnished by the 
MFN participant with a Medicare Part A or Medicare Part B allowed charge 
greater than $0 with a service date within the prior year, to calculate 
25 percent of the MFN participant's average per beneficiary total 
allowed charges for all Medicare Part A and Part B claims with dates of 
service within the prior year.
    (6) CMS subtracts 25 percent of the MFN participant's average per 
beneficiary total allowed charges for all Medicare Part A and Part B 
claims with dates of service within the prior year (as calculated in 
paragraph (d)(5) of this section) from the difference calculated in 
paragraph (d)(4) of this section, to calculate the MFN participant's 
excess reduction amount per beneficiary.
    (e) Reconciliation payment. (1) If CMS in its sole discretion grants 
a financial hardship exemption to an MFN participant for a performance 
year, CMS provides such MFN participant a reconciliation payment for the 
performance year that equals the amount calculated by multiplying the 
excess reduction amount per beneficiary specified in paragraph (d)(6) of 
this section by the total number of beneficiaries that had at least one 
claim for a service furnished by the MFN participant with a Medicare 
Part A or Medicare Part B allowed charge greater than $0 with a service 
date within the performance year.
    (2) The amount of a reconciliation payment provided in accordance 
with this section is--
    (i) Not subject to appeal;
    (ii) Not subject to beneficiary cost-sharing, including any 
deductible or coinsurance; and
    (iii) Made by CMS (or a CMS contractor) as soon as practical.

Subpart D [Reserved]



  Subpart E_Quality Strategy, Beneficiary Protections, and Compliance 
                               Activities



Sec. 513.400  Quality measures.

    (a) General. Quality measures do not adjust model payments to MFN 
participants and are used for monitoring purposes.
    (b) Collection of quality measures. (1) CMS administers a patient 
experience survey to a sample of beneficiaries who receive an MFN Model 
drug. A sample of non-MFN beneficiaries may also be surveyed.
    (2) If during the MFN Model CMS determines that the quality measures 
specified in paragraph (b) of this section are not sufficient to 
adequately monitor the quality of care that MFN beneficiaries are 
receiving from MFN participants or that MFN participants are providing, 
CMS may specify additional measures. CMS applies the following criteria 
when specifying additional quality measures:
    (i) Additional measures are among one or more of the following 
categories:

[[Page 985]]

    (A) Patient experience of care.
    (B) Patient activation
    (C) Shared decision making.
    (D) Adherence.
    (E) Utilization.
    (F) Process measures.
    (ii) Additional measures will not add significant burden to MFN 
participants or beneficiaries.
    (iii) Additional measures utilize an instrument that CMS has used 
previously in a model to adjust payment or for monitoring or evaluation.



Sec. 513.410  Beneficiary protections.

    (a) Beneficiary choice.
    (1) MFN participants must not restrict beneficiaries' ability to 
choose to receive care from any Medicare participating provider or 
supplier or any provider or supplier who has opted out of Medicare.
    (2) The MFN participant must not commit any act or omission, nor 
adopt any policy that inhibits a beneficiary from exercising his or her 
freedom to choose to receive care from any Medicare participating 
provider or supplier or any provider or supplier who has opted out of 
Medicare. Notwithstanding the foregoing, MFN participants may 
communicate to beneficiaries the benefits of receiving care from an MFN 
participant, if otherwise consistent with the requirements of this part 
and applicable law.
    (b) Appeals. An MFN beneficiary and his or her assignees retain 
their right to appeal claims in accordance with part 405 subpart I of 
this chapter.
    (c) Availability of services. MFN participants must not take any 
action to select or avoid treating beneficiaries based on their 
diagnoses, care needs, income levels or other factors that would render 
the beneficiary an ``at-risk beneficiary'' as defined at Sec. 425.20 of 
this chapter.



Sec. 513.420  Monitoring and compliance activities.

    (a) Compliance with laws. (1) Agreement to comply. The MFN 
participant must comply with all applicable laws and regulations.
    (2) Notification. The MFN participant must notify CMS within 15 days 
after becoming aware that the MFN participant is under investigation or 
has been sanctioned by the federal, state, or local government, or any 
licensing authority (including, without limitation, the imposition of 
program exclusion, debarment, civil monetary penalties, corrective 
action plans, and revocation of Medicare billing privileges).
    (b) CMS monitoring and compliance activities. (1) CMS conducts 
monitoring activities to ensure compliance by MFN participants with the 
terms of the MFN Model, to obtain timely information about the effects 
of the MFN Model on MFN beneficiaries, providers, suppliers, and on the 
Medicare program and to facilitate real time identification and response 
to potential issues. Such monitoring activities may include, without 
limitation, the following:
    (i) Documentation requests sent to the MFN participant including, 
without limitation, surveys and questionnaires.
    (ii) Audits of claims data, medical records, and other data from the 
MFN participant.
    (iii) Interviews with any individual or entity participating in the 
MFN Model including members of the MFN participant's leadership, 
management, and staff.
    (iv) Interviews with beneficiaries and their caregivers.
    (v) Site visits to the MFN participants, performed in a manner 
consistent with Sec. 513.420(c).
    (vi) Tracking patient complaints and appeals.
    (2) In conducting monitoring and oversight activities, CMS or its 
designees may use any relevant data or information including without 
limitation, all Medicare claims submitted for items or services 
furnished to beneficiaries in the MFN Model.
    (3) The MFN participant must cooperate with evaluation and 
monitoring activities as may be necessary to enable CMS to evaluate the 
MFN Model in accordance with section 1115A(b)(4) of the Act and to 
conduct monitoring activities under this section.
    (c) Site visits. (1) To the extent practicable, CMS or its designee 
provides the MFN participant with no less than 15 days advance notice of 
any site visit.

[[Page 986]]

To the extent practicable, CMS attempts to accommodate a request for 
particular dates in scheduling site visits. However, the MFN participant 
may not request a date that is more than 60 days after the date of the 
initial site visit notice from CMS.
    (2) The MFN participant must ensure that personnel with the 
appropriate responsibilities and knowledge associated with the purpose 
of the site visit are available during all site visits.
    (3) Notwithstanding the foregoing, CMS may perform unannounced site 
visits at all physical locations of the MFN participant at any time to 
investigate concerns about the health or safety of beneficiaries or 
other patients or other program integrity issues.
    (4) Nothing in this part must be construed to limit or otherwise 
prevent CMS from performing site visits permitted or required by 
applicable law.
    (d) Right to correct. If CMS discovers that it has made or received 
an incorrect model-specific payment under the terms of the MFN Model, 
CMS may make payment to, or demand payment from, the MFN participant.



Sec. 513.430  Audits and record retention.

    (a) Right to audit. The Federal Government, including CMS, HHS, and 
the Comptroller General, or their designees, has the right to audit, 
inspect, investigate, and evaluate any documents and other evidence 
regarding implementation of the MFN Model.
    (b) Access to records. MFN participants must maintain and give the 
Federal Government, including CMS, HHS, and the Comptroller General, or 
their designees, access to all such documents and other evidence 
sufficient to enable the audit, evaluation, inspection, or investigation 
of the implementation of the MFN Model, including without limitation, 
documents and other evidence regarding the following:
    (1) The MFN participant's compliance with the terms of the MFN 
Model, including this subpart.
    (2) Quality measure information and the quality of services 
performed under the terms of the MFN Model, including this subpart.
    (3) Patient safety.
    (4) The accuracy of model-specific payments made under the MFN 
Model.
    (5) Utilization of items and services furnished under the MFN Model.
    (6) Other program integrity issues.
    (c) Record retention. The MFN participant must maintain the 
documents and other evidence described in paragraph (b) of this section 
and other evidence for a period of 6 years from the last payment 
received by the MFN participant under the MFN Model or from the date of 
completion of any audit, evaluation, inspection, or investigation, 
whichever is later, unless--
    (1) CMS determines there is a special need to retain a particular 
record or group of records for a longer period and notifies the MFN 
participant at least 30 days before the normal disposition date; or
    (2) There has been a termination, dispute, or allegation of fraud or 
similar fault against the MFN participant, in which case the records 
must be maintained for an additional 6 years from the date of any 
resulting final resolution of the termination, dispute, or allegation of 
fraud or similar fault.



Sec. 513.440  Enforcement authority.

    (a) Remedial action--(1) Grounds for remedial action. In addition to 
any other grounds for remedial action that are permitted under the terms 
of this part, CMS may take one or more of the remedial actions set forth 
in paragraph (a)(2) of this section if CMS determines, in CMS' sole 
discretion, that an MFN participant:
    (i) Has failed to comply with any applicable Medicare program 
requirement, rule, or regulation.
    (ii) Has failed to comply with any of the terms of the MFN Model, 
including applicable requirements of this part.
    (iii) Has systematically engaged in the under delivery or over 
delivery of an MFN Model drug.
    (iv) Has taken any action that threatens the health or safety of an 
MFN beneficiary or other patient.
    (v) Has undergone a change of control that presents a program 
integrity risk.
    (vi) Has submitted false data or made false representations, 
warranties, certifications or attestations in connection with any aspect 
of the MFN Model.

[[Page 987]]

    (vii) Has avoided at-risk beneficiaries, as this term is defined in 
Sec. 425.20 of this chapter.
    (viii) Has avoided patients on the basis of payer status.
    (ix) Is subject to sanctions or final actions of an accrediting 
organization or Federal, State, or local government agency.
    (x) Takes any action that CMS determines for program integrity 
reasons is not in the best interests of the MFN Model or the Medicare 
program, or fails to take any action that CMS determines for program 
integrity reasons should have been taken to further the best interests 
of the MFN Model or Medicare program.
    (xi) Is subject to investigation by HHS (including the HHS Office of 
Inspector General (OIG)) or the Department of Justice due to an 
allegation of fraud or significant misconduct, including being subject 
to the filing of a complaint, filing of a criminal charge, being subject 
to an indictment, being named as a defendant in a False Claims Act qui 
tam matter in which the Federal Government has intervened, or similar 
action;
    (xii) Is the subject of administration enforcement action imposed by 
CMS; or
    (xiii) Has failed to demonstrate improved performance following any 
remedial action imposed under this section.
    (2) Taking remedial actions. If CMS determines that one or more 
grounds for remedial action described in paragraph (a)(1) of this 
section exist, CMS make take one or more of the following remedial 
actions:
    (i) Notifying the MFN participant of the violation.
    (ii) Requiring the MFN participant to provide additional information 
to CMS or its designees.
    (iii) Requiring the MFN participant to develop and implement a 
corrective action plan in a form and manner and by a deadline specified 
by CMS.
    (iv) Subjecting the MFN participant to additional monitoring, 
auditing, or both.
    (v) Removing the MFN participant from the MFN Model.
    (vi) Recouping model-specific payments.
    (vii) Other action as may be permitted under the terms of this part.
    (b) OIG authority. Nothing contained in the terms of the MFN Model 
or this part limits or restricts the authority of the HHS Office of 
Inspector General or any other Federal Government authority or agency, 
including its authority to audit, evaluate, investigate, or inspect 
model participant for violations of any statutes, rules, or regulations 
administered by the Federal Government.



Sec. 513.450  Limitations on review.

    There is no administrative or judicial review under sections 1869 or 
1878 of the Act or otherwise for any of the following:
    (a) The selection of models for testing or expansion under section 
1115A of the Act.
    (b) The selection of organizations, sites, or participants, 
including MFN participants, to test the MFN Model, including a decision 
by CMS to remove an MFN participant from the MFN Model.
    (c) The elements, parameters, scope, and duration of such MFN Model 
for testing or dissemination, including without limitation all of the 
following:
    (1) The selection of the model geographic area for the MFN Model by 
CMS.
    (2) The selection of MFN Model drugs by CMS.
    (3) The selection of included international data, including 
selection of countries, international drug pricing databases, and 
international drug pricing data.
    (d) Determinations regarding budget neutrality under section 
1115A(b)(3) of the Act.
    (e) The termination or modification of the design and implementation 
of an MFN Model under section 1115A(b)(3)(B) of the Act.
    (f) Determinations about expansion of the duration and scope of the 
MFN Model under section 1115A(c) of the Act, including the determination 
that the MFN Model is not expected to meet criteria described in 
paragraphs (c)(1) or (2) of such section.

[[Page 988]]



                            Subpart F_Waivers



Sec. 513.500  Waivers of Medicare program requirements for purposes
of testing the MFN Model.

    CMS waives the Medicare program requirements in the following 
provisions that are necessary solely for purposes of testing the MFN 
Model:
    (a) Sections 1833(t)(6) and 1833(t)(14) of the Act and Sec. Sec. 
419.62 and 419.64 of this chapter related to Medicare payment amounts 
for drugs and biologicals under the hospital outpatient prospective 
payment system (OPPS) as necessary to permit testing of an alternative 
payment amount for MFN Model drugs.
    (b) Section 1833(i)(2)(D) of the Act related to Medicare payment to 
ASCs for drugs and biologicals as necessary to permit testing of an 
alternative payment amount for MFN Model drugs.
    (c) Sections 1847A(b) and 1847A(c) of the Act and Sec. Sec. 414.904 
and 414.802 of this chapter related to use of the ASP-based, WAC-based, 
or other applicable payment methodology and calculation of 
manufacturers' ASP as necessary to permit testing of an alternative 
payment for MFN Model drugs and to exclude certain units of MFN Model 
drugs from manufacturers' ASPs.
    (d) Section 1833(a)(1) of the Act related to Medicare payment 
portion of the allowed payment amount for an included MFN Model drug 
that is determined under Sec. 513.220 as necessary to permit testing of 
an innovative payment approach for the alternative add-on payment 
amount.
    (e) Section 1833(a)(1)(S) of the Act related to Medicare payment for 
drugs and biologicals is 80 percent of the lesser of the actual charge 
or the payment amount established in section 1842(o) of the Act as 
necessary to permit testing of an innovative payment approach for the 
total allowable MFN Model payment as determined under subpart C.
    (f) Section 1833(a)(1)(G) of the Act related to the amounts paid 
with respect to facility services furnished in connection with certain 
surgical procedures and with respect to services furnished to an 
individual in an ASC must be 80 percent of the lesser of the actual 
charge for the services or the amount determined by the Secretary under 
such revised payment system as necessary to permit testing of an 
innovative payment approach for the total allowable MFN Model payment as 
determined under subpart C.
    (g) Section 1833(t) of the Act related to how beneficiary copayment 
is calculated under the OPPS as necessary to permit testing of an 
innovative payment approach for the total allowable MFN Model payment as 
determined under subpart C of this part.
    (h) Section 1833(t)(9)(B) of the Act related to the requirement that 
Medicare account for adjustments to ensure that the amount of 
expenditures under the OPPS for the year does not increase or decrease 
from the estimated amount of expenditures under the OPPS that would have 
been made if the adjustments had not been made.

Subparts G-J [Reserved]



                       Subpart K_Model Termination



Sec. 513.1000  Termination of the MFN Model.

    (a) CMS may terminate the MFN Model for reasons including, but not 
limited to, the following:
    (1) CMS determines that it no longer has the funds to support the 
MFN Model.
    (2) CMS terminates the model in accordance with section 
1115A(b)(3)(B) of the Act.
    (b) As specified in section 1115A(d)(2) of the Act, termination of 
the model in accordance with section 1115A(b)(3)(B) of the Act is not 
subject to administrative or judicial review.

[[Page 989]]



                    SUBCHAPTER I_BASIC HEALTH PROGRAM





PART 600_ADMINISTRATION, ELIGIBILITY, ESSENTIAL HEALTH BENEFITS,
PERFORMANCE STANDARDS, SERVICE DELIVERY REQUIREMENTS, PREMIUM
AND COST SHARING, ALLOTMENTS, AND RECONCILATION--Table of Contents



              Subpart A_General Provisions and Definitions

Sec.
600.1 Scope.
600.5 Definitions and use of terms.

Subpart B_Establishment and Certification of State Basic Health Programs

600.100 Program description.
600.105 Basis, scope, and applicability of subpart B.
600.110 BHP Blueprint.
600.115 Development and submission of the BHP Blueprint.
600.120 Certification of a BHP Blueprint.
600.125 Revisions to a certified BHP Blueprint.
600.130 Withdrawal of a BHP Blueprint prior to implementation.
600.135 Notice and timing of HHS action on a BHP Blueprint.
600.140 State termination of a BHP.
600.142 HHS withdrawal of certification and termination of a BHP.
600.145 State program administration and operation.
600.150 Enrollment assistance and information requirements.
600.155 Tribal consultation.
600.160 Protections for American Indian and Alaska Natives.
600.165 Nondiscrimination standards.
600.170 Annual report content and timing.

                Subpart C_Federal Program Administration

600.200 Federal program compliance reviews and audits.

                  Subpart D_Eligibility and Enrollment

600.300 Basis, scope, and applicability.
600.305 Eligible individuals.
600.310 Application.
600.315 Certified application counselors.
600.320 Determination of eligibility for and enrollment in a standard 
          health plan.
600.330 Coordination with other insurance affordability programs.
600.335 Appeals.
600.340 Periodic determination and renewal of BHP eligibility.
600.345 Eligibility verification.
600.350 Privacy and security of information.

                     Subpart E_Standard Health Plan

600.400 Basis, scope, and applicability.
600.405 Standard health plan coverage.
600.410 Competitive contracting process.
600.415 Contracting qualifications and requirements.
600.420 Enhanced availability of standard health plans.
600.425 Coordination with other insurance affordability programs.

              Subpart F_Enrollee Financial Responsibilities

600.500 Basis, scope, and applicability.
600.505 Premiums.
600.510 Cost-sharing.
600.515 Public schedule of enrollee premium and cost sharing.
600.520 General cost-sharing protections.
600.525 Disenrollment procedures and consequences for nonpayment of 
          premiums.

                       Subpart G_Payment to States

600.600 Basis, scope, and applicability.
600.605 BHP payment methodology.
600.610 Secretarial determination of BHP payment amount.
600.615 Deposit of Federal BHP payment.

                        Subpart H_BHP Trust Fund

600.700 Basis, scope, and applicability.
600.705 BHP trust fund.
600.710 Fiscal policies and accountability.
600.715 Corrective action, restitution, and disallowance of questioned 
          BHP transactions.

    Authority: Section 1331 of the Patient Protection and Affordable 
Care Act of 2010 (Pub. L. 111-148, 124 Stat. 119), as amended by the 
Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, 
124 Stat 1029).

    Source: 79 FR 14140, Mar. 12, 2014, unless otherwise noted.



              Subpart A_General Provisions and Definitions



Sec. 600.1  Scope.

    Section 1331 of the Affordable Care Act, provides for the 
establishment of the Basic Health Program (BHP) under

[[Page 990]]

which a State may enter into contracts for standard health plans 
providing at least essential health benefits to eligible individuals in 
lieu of offering such individuals the opportunity to enroll in coverage 
through an Affordable Insurance Exchange. States that elect to operate a 
BHP will receive federal funding based on the amount of the premium tax 
credit and cost-sharing reductions that would have been available if 
enrollees had obtained coverage through the Exchange.



Sec. 600.5  Definitions and use of terms.

    For purposes of this part, the following definitions apply:
    Advance payments of the premium tax credit means payment of the tax 
credit authorized by 26 U.S.C. 36B and its implementing regulations, 
which are provided on an advance basis to an eligible individual 
enrolled in a QHP through an Exchange in accordance with sections 1402 
and 1412 of the Affordable Care Act.
    Affordable Care Act is 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).
    Basic Health Program (BHP) Blueprint is the operational plan that a 
State must submit to the Secretary of Health and Human Services (HHS) 
for certification to operate a BHP.
    Certification means authority to operate the program which is 
required for program operations but it does not create an obligation on 
the part of the State to implement a BHP.
    Code means the Internal Revenue Code of 1986.
    Cost sharing means any expenditure required by or on behalf of an 
enrollee with respect to covered health benefits; such term includes 
deductibles, coinsurance, copayments, or similar charges, but excludes 
premiums, balance billing amounts for non-network providers and spending 
for non-covered services.
    Enrollee means an eligible individual who is enrolled in a standard 
health plan contracted to operate as part of a BHP.
    Essential health benefits means the benefits described under section 
1302(b) of the Affordable Care Act, as determined in accordance with 
implementing regulations at 45 CFR 156.100 through 156.110 and 156.122 
regarding prescription drugs.
    Family and family size is as defined at 26 CFR 1.36B-1(d).
    Federal fiscal year means the time period beginning October 1st and 
ending September 30th.
    Federal poverty level or FPL means the most recently published 
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).
    Household income is as defined in 26 CFR 1.36B-1(e)(1) and is 
determined in the same way as it is for purposes of eligibility for 
coverage through the Exchange.
    Indian means any individual as defined in section 4 (d) of the 
Indian Self-Determination and Education Assistance Act (Pub. L 93-638).
    Interim certification is an approval status for the initial design 
of a state's Basic Health Program. It does not confer any permission to 
begin enrollment or seek federal funding.
    Lawfully present has the meaning given in 45 CFR 152.2.
    Minimum essential coverage has the meaning set forth at 26 CFR 
1.5000A-2, including coverage recognized by the Secretary as minimum 
essential coverage pursuant to 26 CFR 1.5000A-2(f). Under that 
authority, the Secretary recognizes coverage through a BHP standard 
health plan as minimum essential coverage.
    Modified adjusted gross income is as defined in 26 CFR 1-36B-
1(e)(2).
    Network of health care providers means an entity capable of meeting 
the provision and administration of standard health plan coverage, 
including but not limited to, the provision of benefits, administration 
of premiums and applicable cost sharing and execution of innovative 
features, such as care coordination and care management, and other 
requirements as specified under the Basic Health Program. Such entities 
may include but are not limited to: Accountable Care Organizations, 
Independent Physician Associations, or a large health system.

[[Page 991]]

    Premium means any enrollment fee, premium, or other similar charge 
paid to the standard health plan offeror.
    Preventive health services and items includes those services and 
items specified in 45 CFR 147.130(a).
    Program year means a calendar year for which a standard health plan 
provides coverage for eligible BHP enrollees.
    Qualified health plan or QHP means a health plan that has in effect 
a certification that it meets the standards described in subpart C of 45 
CFR part 156 issued or recognized by each Exchange through which such 
plan is offered in accordance with the process described in subpart K of 
45 CFR part 156, except that such term must not include a qualified 
health plan which is a catastrophic plan described in 45 CFR 155.20.
    Reference plan is a synonym for the EHB base benchmark plan and is 
defined at 45 CFR 156.100.
    Regional compact means an agreement between two or more States to 
jointly procure and enter into contracts with standard health plan 
offeror(s) for the administration and provision of a standard health 
plan under the BHP to eligible individuals in such States.
    Residency is determined in accordance with 45 CFR 155.305(a)(3).
    Single streamlined application has the same meaning as application 
defined at 42 CFR 431.907(b)(1) of this chapter and 45 CFR 155.405(a) 
and (b).
    Standard health plan means a health benefits package, or product, 
that is provided by the standard health plan offeror.
    Standard health plan offeror means an entity that is eligible to 
enter into contracts with the State for the administration and provision 
of a standard health plan under the BHP.
    State means each of the 50 states and the District of Columbia as 
defined by section 1304 of the Act.



Subpart B_Establishment and Certification of State Basic Health Programs



Sec. 600.100  Program description.

    A State Basic Health Program (BHP) is operated consistent with a BHP 
Blueprint that has been certified by the Secretary to meet the 
requirements of this part. The BHP Blueprint is developed by the State 
for certification by the Secretary in accordance with the processes 
described in this subpart.



Sec. 600.105  Basis, scope, and applicability of subpart B.

    (a) Statutory basis. This subpart implements the following sections 
of the Act:
    (1) Section 1331(a)(1) which defines a Basic Health Program.
    (2) Section 1331(a)(2) which requires the Secretary to certify a 
Basic Health Program before it may become operational.
    (3) Section 1331(f) which requires Secretarial oversight through 
annual reviews.
    (b) Scope and applicability. (1) This subpart sets forth provisions 
governing the administration of the BHP, the general requirements for 
development of a BHP Blueprint required for certification, for program 
operations and for voluntary program termination.
    (2) This subpart applies to all States that submit a BHP Blueprint 
and request certification to operate a BHP.



Sec. 600.110  BHP Blueprint.

    The BHP Blueprint is a comprehensive written document submitted by 
the State to the Secretary for certification of a BHP in the form and 
manner specified by HHS which will include an opportunity for states to 
submit a limited set of elements necessary for interim certification at 
the state option. The program must be administered in accordance with 
all aspects of section 1331 of the Affordable Care Act and other 
applicable law, this chapter, and the certified BHP Blueprint.
    (a) Content of a Blueprint. The Blueprint will establish compliance 
with applicable requirements by including a description, or if 
applicable, an assurance of the following:
    (1) The minimum benefits offered under a standard health plan that 
assures inclusion of essential health benefits as described in section 
1302(b) of the Affordable Care Act, in accordance with Sec. 600.405.
    (2) The competitive process, consistent with Sec. 600.410, that the 
State

[[Page 992]]

will undertake to contract for the provision of standard health plans.
    (3) The standard contract requirements, consistent with Sec. 
600.415, that the State will incorporate in its standard health plan 
contracts.
    (4) The methods by which the State will enhance the availability of 
standard health plan coverage as described in Sec. 600.420.
    (5) The methods by which the State will ensure and promote 
coordination with other insurance affordability programs as described in 
Sec. 600.425.
    (6) The premium standards set forth in Sec. 600.505.
    (7) The cost sharing imposed under the BHP, consistent with the 
standards described in Sec. 600.510.
    (8) The disenrollment procedures and consequences for nonpayment of 
premiums consistent with Sec. 600.525, respectively.
    (9) The standards, consistent with Sec. 600.305 used to determine 
eligibility for the program.
    (10) The State's policies regarding enrollment, disenrollment and 
verification consistent with Sec. Sec. 600.320 and 600.345, along with 
a plan to ensure coordination with and eliminate gaps in coverage for 
individuals transitioning to other insurance affordability programs.
    (11) The fiscal policies and accountability procedures, consistent 
with Sec. 600.710.
    (12) The process by which BHP trust fund trustees shall be 
appointed, the qualifications and responsibilities of such trustees, and 
any arrangements to insure or indemnify such trustees against claims for 
breaches of their fiduciary responsibilities.
    (13) A description of how the State will ensure program integrity, 
including how it will address potential fraud, waste, and abuse and 
ensure consumer protections.
    (14) An operational assessment establishing operating agency 
readiness.
    (15) A transition plan if a state participating in 2015 plans to 
propose an alternative enrollment strategy for initial implementation 
consistent with Sec. 600.145. Such a transition plan must include a 
plan for coordination of this initial implementation strategy with the 
Exchange operating in the state, and if beneficiaries will be 
transitioning from Medicaid, with the Medicaid agency.
    (b) Funding plan. (1) The BHP Blueprint must be accompanied by a 
funding plan that describes the enrollment and cost projections for the 
first 12 months of operation and the funding sources, if any, beyond the 
BHP trust fund.
    (2) The funding plan must demonstrate that Federal funds will only 
be used to reduce premiums and cost-sharing or to provide additional 
benefits.
    (c) Transparency. HHS shall make a State's BHP Blueprint available 
on line after it is submitted for certification, and will update the 
posted Blueprint to the extent that it is later revised by the state.



Sec. 600.115  Development and submission of the BHP Blueprint.

    (a) State authority to submit the State Blueprint. A State BHP 
Blueprint must be signed by the State's Governor or by the official with 
delegated authority from the Governor to sign it. A State may choose to 
submit its BHP Blueprint in two parts: The first limited submission to 
secure interim certification and the second full submission to secure 
full certification.
    (b) State Basic Health Program officials. The State must identify in 
the BHP Blueprint the agency and officials within that agency, by 
position or title, who are responsible for program administration, 
operations, and financial oversight.
    (c) Opportunity for public comment. The State must provide an 
opportunity for public comment on the BHP Blueprint content described in 
Sec. 600.110 before submission to the Secretary for certification.
    (1) The State must seek public comment on any significant subsequent 
revisions prior to submission of those revisions to the Secretary for 
certification. Significant revisions are those that alter core program 
operations required by Sec. 600.145(f), as well as changes that alter 
the BHP standard health plan benefit package, or enrollment, 
disenrollment and verification policies.

[[Page 993]]

    (2) The process of seeking public comment must include Federally 
recognized tribes as defined in the Federally Recognized Indian Tribe 
List Act of 1994, 25 U.S.C. 479a, located in the State.
    (d) Submission and timing. The BHP Blueprint must be submitted in a 
manner and format specified by HHS. States may not implement the BHP 
prior to receiving full certification. The date of implementation for 
this purpose is the first day enrollees would receive coverage under the 
BHP. Following the 2015 initial implementation year, a state 
implementing a BHP must coordinate implementation with open enrollment 
of the state's exchange.



Sec. 600.120  Certification of a BHP Blueprint.

    (a) Effective date of certification. The effective date of either 
interim or full certification is the date of signature by the Secretary.
    (b) Payments for periods prior to certification. No payment may be 
made under this part for periods of BHP operation prior to the date of 
full certification.
    (c) Period in which a certified Blueprint remains in effect. The 
certified Blueprint remains in effect until:
    (1) The Blueprint is replaced by Secretarial certification of 
updated Blueprint containing revisions submitted by the State.
    (2) The State terminates the program consistent with Sec. 600.140.
    (3) The Secretary makes a finding that the BHP Blueprint no longer 
meets the standards for certification based on findings in the annual 
review, or reports significant evidence of beneficiary harm, financial 
malfeasance, fraud, waste or abuse by the BHP agency or the State 
consistent with Sec. 600.142.
    (d) Blueprint approval standards for certification. The Secretary 
will certify a BHP Blueprint provided it meets all of the following 
standards:
    (1) The Blueprint contains sufficient information for the Secretary 
to determine that the BHP will comply with the requirements of section 
1331 of the Affordable Care Act and this part.
    (2) The BHP Blueprint demonstrates adequate planning for the 
integration of BHP with other insurance affordability programs in a 
manner that will permit a seamless, coordinated experience for a 
potentially eligible individual.
    (3) The Blueprint is a complete and comprehensive description of the 
BHP and its operations, demonstrating thorough planning and a concrete 
program design, without reserved decisions on operational features.



Sec. 600.125  Revisions to a certified BHP Blueprint.

    (a) Submission of revisions. In the event that a State seeks to make 
significant change(s) that alter program operations the BHP benefit 
package, enrollment, disenrollment and verification policies described 
in the certified BHP Blueprint, the State must submit a revised 
Blueprint to the Secretary for review and certification.
    (b) Continued operations. The state is responsible for continuing to 
operate under the terms of the existing certified Blueprint until and 
unless a revised Blueprint that seeks to make significant change(s) is 
certified, except as specified in paragraph (c) of this section.
    (c) Public health emergency. For the Public Health Emergency, as 
defined in Sec. 400.200 of this chapter, the State may submit to the 
Secretary for review and certification a revised Blueprint, in the form 
and manner specified by HHS, that makes temporary significant changes to 
its BHP that are directly related to the Public Health Emergency and 
would increase enrollee access to coverage. Such revised Blueprints may 
have an effective date retroactive to the first day of the Public Health 
Emergency and through the last day of the Public Health Emergency, or a 
later date if requested by the state and certified by HHS. Such revised 
Blueprints are not subject to the public comment requirements under 
Sec. 600.115(c).

[79 FR 14140, Mar. 12, 2014, as amended at 85 FR 27629, May 8, 2020]



Sec. 600.130  Withdrawal of a BHP Blueprint prior to implementation.

    To the extent that a State has not enrolled eligible individuals 
into the BHP:

[[Page 994]]

    (a) The State may submit a written request to stop any further 
consideration of a previously submitted BHP Blueprint, whether certified 
or not.
    (b) The written request must be signed by the governor, or the State 
official delegated to sign the BHP Blueprint by the governor.
    (c) HHS will respond with a written confirmation that the State has 
withdrawn the Blueprint.



Sec. 600.135  Notice and timing of HHS action on a BHP Blueprint.

    (a) Timely response. HHS will act on all certification and revision 
requests in a timely manner.
    (b) Issues preventing certification. HHS will notify the State in 
writing of any impediments to certification that arise in reviewing a 
proposed BHP Blueprint.
    (c) Reconsideration of decision. HHS will accept a State request for 
reconsideration of a certification decision and provide an impartial 
review against the standards for certification if requested.



Sec. 600.140  State termination of a BHP.

    (a) If a State decides to terminate its BHP, the State must complete 
all of the following prior to the effective date of the termination or 
the indicated dates:
    (1) Submit written notice to the Secretary no later than 120 days 
prior to the proposed termination date accompanied by a proposed 
transition plan that describes procedures to assist consumers with 
transitioning to other insurance affordability programs.
    (2) Resolve concerns expressed by the Secretary and obtain approval 
by the Secretary of the transition plan.
    (3) Submit written notice to all participating standard health plan 
offerors, and enrollees that it intends to terminate the program at 
least 90 days prior to the termination date. The notices to enrollees 
must include information regarding the State's assessment of their 
eligibility for all other insurance affordability programs in the State. 
Notices must meet the accessibility and readability standards at 45 CFR 
155.230(b).
    (4) Transmit all information provided as part of an application, and 
any information obtained or verified by the State or other agencies 
administering insurance affordability programs via secure electronic 
interface, promptly and without undue delay to the agency administering 
the Exchange and the Medicaid agency as appropriate.
    (5) Fulfill its contractual obligations to participating standard 
health plan offerors including the payment of all negotiated rates for 
participants, as well as plan oversight ensuring that participating 
standard health plan offerors fulfill their obligation to cover benefits 
for each enrollee.
    (6) Fulfill data reporting requirements to HHS.
    (7) Complete the annual financial reconciliation process with HHS to 
ensure full compliance with Federal financial obligations.
    (8) Refund any remaining balance in the BHP trust fund.
    (b) [Reserved]



Sec. 600.142  HHS withdrawal of certification and termination 
of a BHP.

    (a) The Secretary may withdraw certification for a BHP Blueprint 
based on a finding that the BHP Blueprint no longer meets the standards 
for certification based on findings in the annual review, findings from 
a program review conducted in accordance with Sec. 600.200 or from 
significant evidence of beneficiary harm, financial malfeasance, fraud, 
waste or abuse.
    (b) Withdrawal of certification for a BHP Blueprint shall occur only 
after the Secretary provides the State with notice of the proposed 
finding that the standards for certification are not met or evidence of 
harm or misconduct in program operations, a reasonable period for the 
State to address the finding (either by substantiating compliance with 
the standards for certification or submitting revisions to the 
Blueprint, or securing HHS approval of a corrective action plan), and an 
opportunity for a hearing before issuing a final finding.
    (c) The Secretary shall make every reasonable effort to resolve 
proposed findings without requiring withdrawal of BHP certification and 
in the event of a decision to withdraw certification, will accept a 
request from the State for reconsideration.

[[Page 995]]

    (d) The effective date of an HHS determination withdrawing BHP 
certification shall not be earlier than 120 days following a final 
finding of noncompliance with the standards for certification.
    (e) Within 30 days following a final finding of noncompliance with 
the standards for certification, the State shall submit a transition 
plan that describes procedures to assist consumers with transitioning to 
other insurance affordability programs, and shall comply with the 
procedures described in Sec. 600.140(a)(2) through (8).



Sec. 600.145  State program administration and operation.

    (a) Program operation. The State must implement its BHP in 
accordance with the approved and fully certified State BHP Blueprint, 
any approved modifications to the State BHP Blueprint and the 
requirements of this chapter and applicable law.
    (b) Eligibility. All persons have a right to apply for a 
determination of eligibility and, if eligible, to be enrolled into 
coverage that conforms to the regulations in this part.
    (c) Statewide program operation. A state choosing to operate a BHP 
must operate it statewide.
    (d) No caps on program enrollment. A State implementing a BHP must 
not be permitted to limit enrollment by setting an income level below 
the income standard prescribed in section 1331 of the Affordable Care 
Act, having a fixed enrollment cap or imposing waiting lists.
    (e) Transition plan. States implementing in 2015 may identify a 
transition period following initial implementation during which the 
state may propose alternative enrollment strategies for approval. The 
transition plan is required to be submitted as part of the state's BHP 
Blueprint consistent with Sec. 600.110.
    (f) Core operations. A State operating a BHP must perform all of the 
following core operating functions:
    (1) Eligibility determinations as specified in Sec. 600.320.
    (2) Eligibility appeals as specified in Sec. 600.335.
    (3) Contracting with standard health plan offerors as specified in 
Sec. 600.410.
    (4) Oversight and financial integrity including, but not limited to, 
operation of the Trust Fund specified at Sec. Sec. 600.705 and 600.710, 
compliance with annual reporting at Sec. 600.170, and providing data 
required by Sec. 600.610 for Federal funding and reconciliation 
processes.
    (5) Consumer assistance as required in Sec. 600.150.
    (6) Extending protections to American Indian/Alaska Natives 
specified at Sec. 600.160, as well as comply with the Civil Rights and 
nondiscrimination provisions specified at Sec. 600.165.
    (7) Data collection and reporting as necessary for efficient and 
effective operation of the program and as specified by HHS to support 
program oversight.
    (8) If necessary, program termination procedures at Sec. 600.145.



Sec. 600.150  Enrollment assistance and information requirements.

    (a) Information disclosure. (1) The State must make accurate, easily 
understood information available to potential applicants and enrollees 
about the BHP coverage option along with information about other 
insurance affordability programs.
    (2) The State must provide accessible information on coverage, 
including additional benefits that may be provided outside of the 
standard health plan coverage, any tiers of coverage it has built into 
the BHP, including who is eligible for each tier.
    (3) The State must require participating standard health plans to 
provide clear information on premiums; covered services including any 
limits on amount, duration and scope of those services; applicable cost-
sharing using a standard format supplied by the State, and other data 
specified in, and in accordance with, 45 CFR 156.220.
    (4) The State must provide information in a manner consistent with 
45 CFR 155.205(c).
    (5) The State must require participating standard health plans to 
make publicly available, and keep up to date (at least quarterly), the 
names and locations of currently participating providers.
    (b) [Reserved]

[[Page 996]]



Sec. 600.155  Tribal consultation.

    The State must consult with Indian tribes located in the State on 
the development and execution of the BHP Blueprint using the tribal 
consultation policy approved by the State Exchange.



Sec. 600.160  Protections for American Indian and Alaska Natives.

    (a) Enrollment. Indians must be extended the same special enrollment 
status in BHP standard health plans as applicable to enrollment in a QHP 
through the Exchange under 45 CFR 155.420(d)(8). Indians will be allowed 
to enroll in, or change enrollment in, standard health plans one time 
per month.
    (b) Cost sharing. No cost sharing may be imposed on Indians under 
the standard health plan.
    (c) Payments to providers. Equal to the protection extended to 
Indian health providers providing services to Indians enrolled in a QHP 
in the individual market through an Exchange at 45 CFR 156.430(g), BHP 
offerors may not reduce the payment for services to Indian health 
providers by the amount of any cost-sharing that would be due from the 
Indian but for the prohibition in paragraph (b) of this section.
    (d) Requirement. Standard health plans must pay primary to health 
programs operated by the Indian Health Service, Indian tribes, tribal 
organizations, and urban Indian organizations for services that are 
covered by a standard health plan.



Sec. 600.165  Nondiscrimination standards.

    (a) The State and standard health plans, must comply with all 
applicable civil rights statutes and 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, Section 1557 of the Affordable Care 
Act, and 45 CFR part 80, part 84, and part 91 and 28 CFR part 35.
    (b) The State must comply with the nondiscrimination provision at 45 
CFR 155.120(c)(2).



Sec. 600.170  Annual report content and timing.

    (a) Content. The State must submit an annual report that includes 
any evidence of fraud, waste, or abuse on the part of participating 
providers, plans, or the State BHP agency known to the State, and a 
detailed data-driven review of compliance with the following:
    (1) Eligibility verification requirements for program participation 
as specified in Sec. 600.345.
    (2) Limitations on the use of Federal funds received by the BHP as 
specified in Sec. 600.705.
    (3) Requirements to collect quality and performance measures from 
all participating standard health plans focusing on quality of care and 
improved health outcomes as specified in sections 1311(c)(3) and (4) of 
the Affordable Care Act and as further described in Sec. 600.415.
    (4) Requirements specified by the Secretary at least 120 days prior 
to the date of the annual report as requiring further study to assess 
continued State compliance with Federal law, regulations and the terms 
of the State's certified Blueprint, based on a Federal review of the BHP 
pursuant to Sec. 600.200, and/or a list of any outstanding 
recommendations from any audit or evaluation conducted by the HHS Office 
of Inspector General that have not been fully implemented, including a 
statement describing the status of implementation and why implementation 
is not complete.
    (b) Timing. The annual reports, in the format specified by the 
Secretary, are due 60 days after the end of each operational year. 
Information that may be required to secure the release of funding for 
the subsequent year may be requested in advance.



                Subpart C_Federal Program Administration



Sec. 600.200  Federal program compliance reviews and audits.

    (a) Federal compliance review of the State BHP. To determine whether 
the State is complying with the Federal requirements and the provisions 
of its BHP Blueprint, HHS may review, as needed, but no less frequently 
than annually, the compliance of the State

[[Page 997]]

BHP with applicable laws, regulations and interpretive guidance. This 
review may be based on the State's annual report submitted under Sec. 
600.170, or may be based on direct Federal review of State 
administration of the BHP Blueprint through analysis of the State's 
policies and procedures, reviews of agency operation, examination of 
samples of individual case records, and additional reports and/or data 
as determined by the Secretary.
    (b) Action on compliance review findings. The compliance review will 
identify the following action items:
    (1) Requirements that need further study or data to assess continued 
State compliance with Federal law, regulations and the terms of the 
State's certified Blueprint. Such findings must be addressed in the next 
State annual report due no more than 120 days after the date of the 
issuance of the Federal compliance review.
    (2) Requirements with which the State BHP does not appear to be in 
compliance that could be the basis for withdrawal of BHP certification. 
Such findings must be resolved by the State (either by substantiating 
compliance with the standards for certification or submitting revisions 
to the Blueprint). If not resolved, such action items can be the basis 
for a proposed finding for withdrawal of BHP certification.
    (3) Requirements with which the State BHP does not appear to be in 
compliance and are not a basis for withdrawal of BHP certification but 
require revision to the Blueprint must be resolved by the State. If not 
resolved, such action items can be the basis for denial of other 
Blueprint revisions.
    (4) Improper use of BHP trust fund resources. The State and the BHP 
trustees shall be given an opportunity to review and resolve concerns 
regarding improper use of BHP trust funds, including failure to use 
these funds as specified in Sec. 600.705. As indicated in Sec. 
600.715(a) through (c), the state may do this either by substantiating 
the proper use of trust fund resources as specified in Sec. 600.705(c) 
or by taking corrective action, which include changes to procedures to 
ensure proper use of trust fund resources, and restitution of improperly 
used resources to the trust fund.
    (c) The HHS Office of Inspector General (OIG) may periodically audit 
State operations and standard health plan practices as described in 
Sec. 430.33 of this chapter. Final reports on those audits shall be 
transmitted to both the State and the Secretary for actions on findings. 
The State and the BHP trustees shall be given an opportunity to resolve 
concerns about improper use of BHP trust funds as indicated in Sec. 
600.715(a) through (c): either by substantiating the proper use of trust 
fund, or by taking corrective action that includes changes to procedures 
to ensure proper use of trust fund resources, and restitution of 
improperly used resources to the trust fund.



                  Subpart D_Eligibility and Enrollment



Sec. 600.300  Basis, scope, and applicability.

    (a) Statutory basis. This subpart interprets and implements section 
1331(e) of the Affordable Care Act, which sets forth eligibility 
standards for the BHP and prohibits eligible individuals from being 
treated as qualified individuals under section 1312 of the Affordable 
Care Act and enrolling in qualified health plans offered through the 
Exchange.
    (b) Scope and applicability. This subpart sets forth the 
requirements for all BHPs established under section 1331 of the 
Affordable Care Act regarding eligibility standards and application 
screening and enrollment procedures.



Sec. 600.305  Eligible individuals.

    (a) Eligibility standards The State must determine individuals 
eligible to enroll in a standard health plan if they:
    (1) Are residents of the State.
    (2) Have household income which exceeds 133 percent but does not 
exceed 200 percent of the FPL for the applicable family size, or, in the 
case of an individual who is a lawfully present non-citizen, ineligible 
for Medicaid or CHIP due to such immigration status, whose household 
income is between zero and 200 percent of the FPL for the applicable 
family size.
    (3) Are not eligible to enroll in minimum essential coverage (other 
than a standard health plan). If an individual

[[Page 998]]

meets all other eligibility standards, and--
    (i) Is eligible for, or enrolled in, coverage that does not meet the 
definition of minimum essential coverage, including Medicaid that is not 
minimum essential coverage, the individual is eligible to enroll in a 
standard health plan without regard to eligibility or enrollment in 
Medicaid; or
    (ii) Is eligible for Employer Sponsored Insurance (ESI) that is 
unaffordable (as determined under section 36B(c)(2)(C) of the Internal 
Revenue Code), the individual is eligible to enroll in a standard health 
plan.
    (4) Are 64 years of age or younger.
    (5) Are either a citizen or lawfully present non-citizen.
    (6) Are not incarcerated, other than during a period pending 
disposition of charges.
    (b) Eligibility restrictions. With the exception of during an 
approved implementation period specified in a transition plan in 
accordance with Sec. 600.145, the State may not impose conditions of 
eligibility other than those identified in this section, including, but 
not limited to, restrictions on eligibility based on geographic location 
or imposition of an enrollment cap or a waiting period for individuals 
previously eligible for or enrolled in other coverage.



Sec. 600.310  Application.

    (a) Single streamlined application. The State must use the single 
streamlined application used by the State in accordance with Sec. 
435.907(b) of this chapter and 45 CFR 155.405(a) and (b).
    (b) Opportunity to apply and assistance with application. The terms 
of Sec. Sec. 435.906, 435.907(g) and 435.908 of this chapter, requiring 
the State to provide individuals the opportunity to apply and receive 
assistance with an application in the Medicaid program, apply in the 
same manner to States in the administration of the BHP.
    (c) Authorized representatives. The State may choose to permit the 
use of an authorized representative designated by an applicant or 
beneficiary to assist with the individual's application, eligibility 
renewal and other ongoing communication with the BHP. If the State 
chooses this option, the State must follow the standards set forth at 
either 45 CFR 155.227 or 42 CFR 435.923.



Sec. 600.315  Certified application counselors.

    The State may have a program to certify application counselors to 
assist individuals to apply for enrollment in the BHP and other 
insurance affordability programs. If the State chooses this option, the 
State must follow the procedures and standards for such a program set 
forth in the regulations at either 45 CFR 155.225 or 42 CFR 435.908.



Sec. 600.320  Determination of eligibility for and enrollment
in a standard health plan.

    (a) Determining eligibility to enroll in a standard health plan may 
be performed by a State or through delegation to a local governmental 
entity, including a governmental entity that determines eligibility for 
Medicaid or CHIP, and may be delegated by the State to an Exchange that 
is a government agency.
    (b) Timely determinations. The terms of 42 CFR 435.912 (relating to 
timely determinations of eligibility under the Medicaid program) apply 
to eligibility determinations for enrollment in a standard health plan 
exclusive of Sec. 435.912(c)(3)(i). The standards established by the 
State must be included in the BHP Blueprint.
    (c) Effective date of eligibility. The State must establish a 
uniform method of determining the effective date of eligibility for 
enrollment in a standard health plan following either the Exchange 
standards at 45 CFR 155.420(b)(1) or the Medicaid process at 42 CFR 
435.915 exclusive of Sec. 435.915(a).
    (d) Enrollment periods. The State must either offer enrollment and 
special enrollment periods no more restrictive than those required for 
an Exchange at 45 CFR 155.410 and 155.420 or follow the Medicaid process 
permitting continuous open enrollment throughout the year.



Sec. 600.330  Coordination with other insurance affordability programs.

    (a) Coordination. The State must establish eligibility and 
enrollment mechanisms and procedures to maximize coordination with the 
Exchange,

[[Page 999]]

Medicaid and CHIP. The terms of 45 CFR 155.345(a) regarding the 
agreements between insurance affordability programs apply to a BHP. The 
State BHP agency must fulfill the requirements of 42 CFR 435.1200(d) and 
(e) and, if applicable, paragraph (c) for BHP eligible individuals.
    (b) Coordinated determinations of eligibility. The agency 
administering BHP must establish and maintain processes to make income 
eligibility determinations using modified adjusted gross income, and to 
ensure that applications received by the agency, to the extent warranted 
and permitted under delegations from other agencies administering 
insurance affordability programs, also result in eligibility assessments 
or determinations for those other programs. The BHP must also accept 
applications transferred from other agencies administering insurance 
affordability programs, and ensure that individuals assessed or 
determined eligible for BHP by such other agencies are afforded the 
opportunity to enroll in a standard health plan without undue delay. 
Individuals submitting applications to any of the aforementioned 
agencies must not be required to duplicate the submission of 
information.
    (c) Account transfers. The agency administering the BHP must 
participate in the secure exchange of information with agencies 
administering other insurance affordability programs, using the 
standards set forth under 45 CFR 155.345(h) regarding electronic account 
transfers.
    (d) Notification to referring agency. The terms in Sec. 
435.1200(d)(5) regarding the notification to other programs of the final 
determination of eligibility apply equally to States administering a 
BHP.
    (e) Notice of decision concerning eligibility. Every application for 
BHP shall result in a determination of eligibility or ineligibility, 
unless the application has been withdrawn, the applicant has died, or 
the applicant cannot be located. Written notices of eligibility 
determinations shall be provided and shall be coordinated with other 
insurance affordability programs and Medicaid. Electronic notices shall 
be provided to the extent consistent with Sec. 435.918(b).



Sec. 600.335  Appeals.

    (a) Notice of eligibility appeal rights. Eligibility determinations 
must include a notice of the right to appeal the determination, and 
instructions regarding how to file an appeal.
    (b) Appeals process. Individuals must be given the opportunity to 
appeal BHP eligibility determinations through the appeals rules of the 
state's Medicaid program or the Exchange. However, this process may not 
include an appeal to the federal Department of Health and Human 
Services.
    (c) Accessibility. Notices must be provided and the appeals process 
must be conducted in a manner accessible to individuals with limited 
English proficiency and persons with disabilities.



Sec. 600.340  Periodic redetermination and renewal of BHP eligibility.

    (a) Periodic review of eligibility. An individual is subject to 
periodic review of eligibility every 12 months unless the eligibility is 
redetermined sooner based on new information received and verified from 
enrollee reports or data sources. The State must require enrollees to 
report changes in circumstances, at least to the extent that they would 
be required to report such changes if enrolled in coverage through the 
Exchange, consistent with 45 CFR 155.330(b).
    (b) Renewal of coverage. If an enrollee remains eligible for 
coverage in the BHP, the enrollee will be afforded notice of a 
reasonable opportunity at least annually to change plans to the extent 
the BHP offers a choice of plans, and shall remain in the plan selected 
for the previous year unless such enrollee terminates coverage from the 
plan by selecting a new plan or withdrawing from a plan, or the plan is 
no longer available as a standard health plan in BHP. Enrollees in plans 
that are no longer available will be given a reasonable opportunity to 
select a new plan, and if they do not select a new plan will be enrolled 
in another plan pursuant to a methodology set forth in the State's 
Blueprint.
    (c) Procedures. The State shall choose to apply equally all the 
redetermination procedures described in either 45 CFR 155.335 or 42 CFR 
435.916(a) in administering a BHP.

[[Page 1000]]

    (d) Verification. The State must verify information needed to 
redetermine and renew eligibility in accordance with Sec. 600.345 and 
comply with the requirements set forth in Sec. 600.330 relating to 
screening individuals for other insurance affordability programs and 
transmitting such individuals' electronic accounts and other relevant 
information to the other program, as appropriate.
    (e) Notice to enrollee. The State must provide an enrollee with an 
annual notice of redetermination of eligibility. The annual notice 
should include all current information used for the most recent 
eligibility determination. The enrollee is required to report any 
changes with respect to information listed within the notice within 30 
days of the date of the notice. The State must verify information in 
accordance with Sec. 600.345.
    (f) Continuous eligibility. The state is not required to redetermine 
eligibility of BHP enrollees more frequently than every 12 months, 
regardless of changes of circumstances, as long as the enrollees are 
under age 65, are not otherwise enrolled in minimum essential coverage 
and remain residents of the State.



Sec. 600.345  Eligibility verification.

    (a) The State must verify the eligibility of an applicant or 
beneficiary for BHP consistent either with the standards and procedures 
set forth in--
    (1) Medicaid regulations at Sec. Sec. 435.945 through 435.956 of 
this chapter; or
    (2) Exchange regulations at 45 CFR 155.315 and 155.320.
    (b) [Reserved]



Sec. 600.350  Privacy and security of information.

    The State must comply with the standards and procedures set forth in 
45 CFR 155.260(b) and (c) as are applicable to the operation of the BHP.



                     Subpart E_Standard Health Plan



Sec. 600.400  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements sections 1331(b), (c), 
and (g) of the Affordable Care Act, which set forth provisions regarding 
the minimum coverage standards under BHP, as well as the delivery of 
such coverage, including the contracting process for standard health 
plan offerors participating in the BHP.
    (b) Scope and applicability. This subpart consists of provisions 
relating to all BHPs for the delivery of, at a minimum, the ten 
essential health benefits as described in section 1302(b) of the 
Affordable Care Act, the contracting process by which States must 
contract for the provision of standard health plans, the minimum 
requirements States must include in their standard health plan 
contracts, the minimum coverage standards provided by the standard 
health plan offeror, and other applicable requirements to enhance the 
coordination of the provision of standard health plan coverage.



Sec. 600.405  Standard health plan coverage.

    (a) Essential Health Benefits (EHB). Standard health plan coverage 
must include, at a minimum, the essential health benefits as determined 
and specified under 45 CFR 156.110, and 45 CFR 156.122 regarding 
prescription drugs, except that States may select more than one base 
benchmark option from those codified at 45 CFR 156.100 for establishing 
essential health benefits for standard health plans. Additionally, 
States must comply with 45 CFR 156.122(a)(2) by requiring participating 
plans to submit their drug list to the State.
    (b) Additional required benefits. Where the standard health plan for 
BHP is subject to State insurance mandates, the State shall adopt the 
determination of the Exchange at 45 CFR 155.170(a)(3) in determining 
which benefits enacted after December 31, 2011 are in addition to EHB.
    (c) Periodic review. Essential health benefits must include any 
changes resulting from periodic reviews required by section 
1302(b)(4)(G) of the Affordable Care Act. The provision of such 
essential health benefits must meet all the requirements of 45 CFR 
156.115.
    (d) Non-discrimination in benefit design. The terms of 45 CFR 
156.125 applies to standard health plans offered under the BHP.

[[Page 1001]]

    (e) Compliance. The State and standard health plans must comply with 
prohibitions on federal funding for abortion services at 45 CFR 156.280.



Sec. 600.410  Competitive contracting process.

    (a) General requirement. In order to receive initial HHS 
certification as described in Sec. 600.120, the State must assure in 
its BHP Blueprint that it complies with the requirements set forth in 
this section.
    (b) Contracting process. The State must:
    (1) Conduct the contracting process in a manner providing full and 
open competition consistent with the standards of 45 CFR 92.36(b) 
through (i);
    (2) Include a negotiation of the elements described in paragraph (d) 
of this section on a fair and adequate basis; and
    (3) Consider the additional elements described in paragraph (e) of 
this section.
    (c) Initial implementation exceptions. (1) If a State is not able to 
implement a competitive contracting process described in paragraph (b) 
of this section for program year 2015, the State must include a 
justification as to why it cannot meet the conditions in paragraph (b), 
as well as a description of the process it will use to enter into 
contracts for the provision of standard health plans under BHP.
    (2) The State must include a proposed timeline that implements a 
competitive contracting process, as described in paragraph (b) of this 
section, for program year 2016.
    (3) Initial implementation exceptions are subject to HHS approval 
consistent with the BHP Blueprint review process established in Sec. 
600.120, and may only be in effect for benefit year 2015.
    (d) Negotiation criteria. The State must assure that its competitive 
contracting process includes the negotiation of:
    (1) Premiums and cost sharing, consistent with the requirements at 
Sec. Sec. 600.505 and 600.510(e);
    (2) Benefits, consistent with the requirements at Sec. 600.405;
    (3) Inclusion of innovative features, such as:
    (i) Care coordination and care management for enrollees, with a 
particular focus on enrollees with chronic health conditions;
    (ii) Incentives for the use of preventive services; and
    (iii) Establishment of provider-patient relationships that maximize 
patient involvement in their health care decision-making, including the 
use of incentives for appropriate health care utilization and patient 
choice of provider.
    (e) Other considerations: The State shall also include in its 
competitive process criteria to ensure:
    (1) Consideration of health care needs of enrollees;
    (2) Local availability of, and access, to health care providers to 
ensure the appropriate number, mix and geographic distribution to meet 
the needs of the anticipated number of enrollees in the service area 
(including but not limited to services provided by essential community 
providers, as defined in 45 CFR 156.235) so that access to services is 
at least sufficient to meet the access standards applicable under 42 CFR 
part 438, subpart D, or 45 CFR 156.230 and 156.235;
    (3) Use of a managed care process, or a similar process to improve 
the quality, accessibility, appropriate utilization, and efficiency of 
services provided to enrollees;
    (4) Performance measures and standards focused on quality of care 
and improved health outcomes as specified in Sec. 600.415;
    (5) Coordination between other health insurance affordability 
programs to ensure enrollee continuity of care as described in Sec. 
600.425; and
    (6) Measures to prevent, identify, and address fraud, waste and 
abuse and ensure consumer protections.
    (f) Discrimination. Nothing in the competitive process shall permit 
or encourage discrimination in enrollment based on pre-existing 
conditions or other health status-related factors.



Sec. 600.415  Contracting qualifications and requirements.

    (a) Eligible offerors for standard health plan contracts. A State 
may enter into contracts for the administration and provision of 
standard health plans

[[Page 1002]]

under the BHP with, but not limited to, the following entities:
    (1) Licensed health maintenance organization.
    (2) Licensed health insurance insurer.
    (3) Network of health care providers demonstrating capacity to meet 
the criteria set forth in Sec. 600.410(d).
    (4) Non-licensed health maintenance organizations participating in 
Medicaid and/or CHIP.
    (b) General contract requirements. (1) A State contracting with 
eligible standard health plan offerors described in paragraph (a) of 
this section must include contract provisions addressing network 
adequacy, service provision and authorization, quality and performance, 
enrollment procedures, disenrollment procedures, noticing and appeals, 
provisions protecting the privacy and security of personally 
identifiable information, and other applicable contract requirements as 
determined by the Secretary to the extent that the service delivery 
model furthers the objectives of the program.
    (2) All contracts under this part must include provisions that 
define a sound and complete procurement contract, as required by 45 CFR 
92.36(i).
    (3) To the extent that the standard health plan is health insurance 
coverage offered by a health insurance issuer, the contract must provide 
that the medical loss ratio is at least 85 percent.
    (c) Notification of State election. To receive HHS certification, 
the State must include in its BHP Blueprint the standard set of contract 
requirements described in paragraph (b) of this section that will be 
incorporated into its standard health plan contracts.



Sec. 600.420  Enhanced availability of standard health plans.

    (a) Choice of standard health plans offerors. (1) The State must 
assure that standard health plans from at least two offerors are 
available to enrollees under BHP. This assurance shall be reflected in 
the BHP Blueprint, which if applicable, shall also include a description 
of how it will further ensure enrollee choice of standard health plans.
    (2) If a State is not able to assure choice of standard health plan 
offerors, the State may request an exception to the requirement set 
forth in paragraph (a)(1) of this section, which must include a 
justification as to why it cannot assure choice of standard health plan 
offeror as well as demonstrate that the State has reviewed its 
competitive contracting process to determine the following:
    (i) Whether all contract requirements and qualifications are 
required under the federal framework for BHP;
    (ii) Whether additional negotiating flexibility would be consistent 
with the minimum statutory requirements and available BHP funding: and
    (iii) Whether potential bidders have received sufficient information 
to encourage participation in the BHP competitive contracting process.
    (b) Use of regional compacts. (1) A State may enter into a joint 
procurement with other States to negotiate and contract with standard 
health plan offerors to administer and provide standard health plans 
statewide, or in geographically specific areas within the States, to BHP 
enrollees residing in the participating regional compact States.
    (2) A State electing the option described in paragraph (b)(1) of 
this section that also contracts for the provision of a geographically 
specific standard health plan must assure that enrollees, regardless of 
residency within the State, continue to have choice of at least two 
standard health plans.
    (3) A State electing the option described in paragraph (b)(1) of 
this section must include in its BHP Blueprint all of the following:
    (i) The other State(s) entering into the regional compact.
    (ii) The specific areas within the participating States that the 
standard health plans will operate, if applicable.
    (A) If the State contracts for the provision of a geographically 
specific standard health plan, the State must describe in its BHP 
Blueprint how it will assure that enrollees, regardless of location 
within the State, continue to have choice of at least two standard 
health plan offerors.
    (B) [Reserved]
    (iii) An assurance that the competitive contracting process used in 
the joint procurement of the standard

[[Page 1003]]

health plans complies with the requirements set forth in Sec. 600.410.
    (iv) Any variations that may occur as a result of regional 
differences between the participating states with respect to benefit 
packages, premiums and cost sharing, contracting requirements and other 
applicable elements as determined by HHS.



Sec. 600.425  Coordination with other insurance affordability 
programs.

    A State must ensure coordination for the provision of health care 
services to promote enrollee continuity of care between Medicaid, CHIP, 
Exchange and any other state-administered health insurance programs. The 
State's BHP Blueprint must describe how it will ensure such 
coordination.



              Subpart F_Enrollee Financial Responsibilities



Sec. 600.500  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements section 1331(a) of the 
Affordable Care Act, which sets forth provisions regarding the 
establishment of the BHP and requirements regarding monthly premiums and 
cost sharing for enrollees.
    (b) Scope and applicability. This subpart consists of provisions 
relating to the imposition of monthly premiums and cost-sharing under 
all state BHPs.



Sec. 600.505  Premiums.

    (a) Premium requirements. (1) For premiums imposed on enrollees, the 
State must assure that the monthly premium imposed on any enrollee does 
not exceed the monthly premium that the enrollee would have been 
required to pay had he or she enrolled in a plan with a premium equal to 
the premium of the applicable benchmark plan, as defined in 26 CFR 
1.36B-3(f). The State must assure that when determining the amount of 
the enrollee's monthly premium, the State took into account reductions 
in the premium resulting from the premium tax credit that would have 
been paid on the enrollee's behalf.
    (2) This assurance must be reflected in the BHP Blueprint, which 
shall also include:
    (i) The group or groups of enrollees subject to premiums.
    (ii) The collection method and procedure for the payment of an 
enrollee's premium.
    (iii) The consequences for an enrollee or applicant who does not pay 
a premium.
    (b) [Reserved]



Sec. 600.510  Cost-sharing.

    (a) Cost-sharing requirements. (1) For cost sharing imposed on 
enrollees, the State must assure the following:
    (i) The cost sharing imposed on enrollees meet the standards 
detailed in Sec. 600.520(c).
    (ii) The establishment of an effective system to monitor and track 
the cost-sharing standards consistent with Sec. 600.520(b) through (d).
    (2) This assurance must be reflected in the BHP Blueprint, which 
shall also include the group or groups of enrollees subject to the cost 
sharing.
    (b) Cost sharing for preventive health services. A State may not 
impose cost sharing with respect to the preventive health services or 
items, as defined in, and in accordance with 45 CFR 147.130.



Sec. 600.515  Public schedule of enrollee premium and cost sharing.

    (a) The State must ensure that applicants and enrollees have access 
to information about all of the following, either upon request or 
through an Internet Web site:
    (1) The amount of and types of enrollee premiums and cost sharing 
for each standard health plan that would apply for individuals at 
different income levels.
    (2) The consequences for an applicant or an enrollee who does not 
pay a premium.
    (b) The information described in paragraph (a) of this section must 
be made available to applicants for standard health plan coverage and 
enrollees in such coverage, at the time of enrollment and reenrollment, 
after a redetermination of eligibility, when premiums, cost sharing, and 
annual limitations on cost sharing are revised, and upon request by the 
individual.

[[Page 1004]]



Sec. 600.520  General cost-sharing protections.

    (a) Cost-sharing protections for lower income enrollees. The State 
may vary premiums and cost sharing based on household income only in a 
manner that does not favor enrollees with higher income over enrollees 
with lower income.
    (b) Cost-sharing protections to ensure enrollment of Indians. A 
State must ensure that standard health plans meet the standards in 
accordance with 45 CFR 156.420(b)(1) and (d).
    (c) Cost-sharing standards. A State must ensure that standard health 
plans meet:
    (1) The standards in accordance with 45 CFR 156.420(c) and (e); and
    (2) The cost-sharing reduction standards in accordance with 45 CFR 
156.420(a)(1) for an enrollee with household income at or below 150 
percent of the FPL, and 45 CFR 156.420(a)(2) for an enrollee with 
household income above 150 percent of the FPL.
    (3) The State must establish an effective system to monitor 
compliance with the cost-sharing reduction standards in paragraph (c) of 
this section, and the cost-sharing protections to ensure enrollment of 
Indians in paragraph (b) of this section to ensure that enrollees are 
not held responsible for such monitoring activity.
    (d) Acceptance of certain third party payments. States must ensure 
that standard health plans must accept premium and cost-sharing payments 
from the following third party entities on behalf of plan enrollees:
    (1) Ryan White HIV/AIDS Programs under title XXVI of the Public 
Health Service Act;
    (2) Indian tribes, tribal organizations or urban Indian 
organizations; and
    (3) State and federal government programs.



Sec. 600.525  Disenrollment procedures and consequences for nonpayment
of premiums.

    (a) Disenrollment procedures due to nonpayment of premium. (1) A 
State must assure that it is in compliance with the disenrollment 
procedures described in 45 CFR 155.430. This assurance must be reflected 
in the state's BHP Blueprint.
    (2) A State electing to enroll eligible individuals in accordance 
with 45 CFR 155.410 and 155.420 must comply with the premium grace 
period standards set forth in 45 CFR 156.270 for required premium 
payment prior to disenrollment.
    (3) A State electing to enroll eligible individuals throughout the 
year must provide an enrollee a 30-day grace period to pay any required 
premium prior to disenrollment.
    (b) Consequences of nonpayment of premium. (1) A State electing to 
enroll eligible individuals in accordance with 45 CFR 155.410 and 
155.420 may not restrict reenrollment to BHP beyond the next open 
enrollment period.
    (2) A State electing to enroll eligible individuals throughout the 
year must comply with the reenrollment standards set forth in Sec. 
457.570(c) of this chapter. If applicable, the State must define the 
length of its premium lockout period in its BHP Blueprint.



                       Subpart G_Payment to States



Sec. 600.600  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements section 1331(d)(1) and 
(3) of the Affordable Care Act regarding the transfer of Federal funds 
to a State's BHP trust fund and the Federal payment amount to a State 
for the provision of BHP.
    (b) Scope and applicability. This subpart consists of provisions 
relating to the methodology used to calculate the amount of payment to a 
state in a given Federal fiscal year for the provision of BHP and the 
process and procedures by which the Secretary establishes a State's BHP 
payment amount.



Sec. 600.605  BHP payment methodology.

    (a) General calculation. The Federal payment for an eligible 
individual in a given Federal fiscal year is the sum of the premium tax 
credit component, as described in paragraph (a)(1) of this section, and 
the cost-sharing reduction component, as described in paragraph (a)(2) 
of this section.
    (1) Premium tax credit component. The premium tax credit component 
equals 95 percent of the premium tax credit for which the eligible 
individual would

[[Page 1005]]

have qualified had he or she been enrolled in a qualified health plan 
through an Exchange in a given calendar year, adjusted by the relevant 
factors described in paragraph (b) of this section.
    (2) Cost-sharing reduction component. The cost-sharing reduction 
component equals 95 percent of the cost of the cost-sharing reductions 
for which the eligible individual would have qualified had he or she 
been enrolled in a qualified health plan through an Exchange in a given 
calendar year adjusted by the relevant factors described in paragraph 
(b) of this section.
    (b) Relevant factors in the payment methodology. In determining the 
premium tax credit and cost-sharing reduction components described in 
paragraph (a) of this section, the Secretary will consider the following 
factors to determine applicable adjustments:
    (1) Age of the enrollee;
    (2) Income of the enrollee;
    (3) Self-only or family coverage;
    (4) Geographic differences in average spending for health care 
across rating areas;
    (5) Health status of the enrollee for purposes of determining risk 
adjustment payments and reinsurance payments had the enrollee been 
enrolled in a qualified health plan through an Exchange;
    (6) Reconciliation of the premium tax credit or cost-sharing 
reductions had such reconciliation occurred if an enrollee had been 
enrolled in a qualified health plan through an Exchange;
    (7) Marketplace experience in other states with respect to Exchange 
participation and the effect of the premium tax credit and cost-sharing 
reductions provided to residents, particularly those residents with 
income below 200 percent of the FPL; and
    (8) Other factors affecting the development of the methodology as 
determined by the Secretary.
    (c) Annual adjustments to payment methodology. The Secretary will 
adjust the payment methodology on a prospective basis to adjust for any 
changes in the calculation of the premium tax credit and cost-sharing 
reduction components to the extent that necessary data is available for 
the Secretary to prospectively determine all relevant factors, as 
specified in paragraph (b) of this section.



Sec. 600.610  Secretarial determination of BHP payment amount.

    (a) Proposed payment notice. (1) Beginning in FY 2015 and each 
subsequent year thereafter, the Secretary will determine and publish in 
a Federal Register document the next fiscal year's BHP payment 
methodology. The Secretary will publish this document annually in 
October upon receiving certification from the Chief Actuary of CMS.
    (2) A State may be required to submit data in accordance with the 
published proposed payment document in order for the Secretary to 
determine the State's payment rate as described in paragraph (b) of this 
section.
    (b) Final payment notice. (1) The Secretary will determine and 
publish the final BHP payment methodology and BHP payment amounts 
annually in February in a Federal Register document.
    (2) Calculation of payment rates. State payment rates are determined 
by the Secretary using the final BHP payment methodology, data requested 
in the proposed payment notice described in paragraph (a) of this 
section, and, if needed, other applicable data as determined by the 
Secretary.
    (c) State specific aggregate BHP payment amounts--(1) Prospective 
aggregate payment amount. The Secretary will determine, on a quarterly 
basis, the prospective aggregate BHP payment amount by multiplying the 
payment rates described in paragraph (b) of this section by the 
projected number of enrollees. This calculation would be made for each 
category of enrollees based on enrollee characteristics and the other 
relevant factors considered when determining the payment methodology. 
The prospective aggregate BHP payment amount would be the sum of the 
payments determined for each category of enrollees for a State.
    (2) Retrospective adjustment to state specific aggregate payment 
amount for enrollment and errors. (i) Sixty days after the end of each 
fiscal year quarter, the Secretary will calculate a retrospective 
adjustment to the previous quarter's specific aggregate payment

[[Page 1006]]

amount by multiplying the payment rates described in paragraph (b) of 
this section by actual enrollment for the respective quarter. This 
calculation would be made for each category of enrollees based on 
enrollee characteristics and the other relevant factors considered when 
determining the payment methodology. The adjusted BHP payment amount 
would be the sum of the payments determined for each category of 
enrollees for a State.
    (ii) Upon determination that a mathematical error occurred during 
the application of the BHP funding methodology, the Secretary will 
recalculate the state's BHP payment amount and make any necessary 
adjustments in accordance with paragraph (c)(2)(iv) of this section.
    (iii) To the extent that the final payment notice described in 
paragraph (b) of this section permits retrospective adjustments to the 
state's BHP payment amount (due to the lack of necessary data for the 
Secretary to prospectively determine the relevant factors comprising the 
premium tax credit and cost-sharing reductions components of the BHP 
funding methodology), the Secretary will recalculate the state's BHP 
payment amount and make any necessary adjustments in accordance with 
paragraph (c)(2)(iv) of this section.
    (iv) Any difference in the adjusted payment and the prospective 
aggregate payment amount will result in either:
    (A) A deposit of the difference amount into the State's BHP trust 
fund; or
    (B) A reduction in the upcoming quarter's prospective aggregate 
payment as described in paragraph (c)(1) of this section by the 
difference amount.



Sec. 600.615  Deposit of Federal BHP payment.

    HHS will make quarterly deposits into the state's BHP trust fund 
based on the aggregate quarterly payment amounts described in Sec. 
600.610(c).



                        Subpart H_BHP Trust Fund



Sec. 600.700  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements section 1331(d)(2) of 
the Affordable Care Act, which set forth provisions regarding BHP trust 
fund expenditures, fiscal policies and accountability standards and 
restitution to the BHP trust fund for unallowable expenditures.
    (b) Scope and applicability. This subpart sets forth a framework for 
BHP trust funds and accounting, establishing sound fiscal policies and 
accountability standards and procedures for the restitution of 
unallowable BHP trust fund expenditures.



Sec. 600.705  BHP trust fund.

    (a) Establishment of BHP trust fund. (1) The State must establish a 
BHP trust fund with an independent entity, or in a segregated account 
within the State's fund structure.
    (2) The State must identify trustees responsible for oversight of 
the BHP trust fund.
    (3) Trustees must specify individuals with the power to authorize 
withdrawal of funds for allowable trust fund expenditures.
    (b) Non-Federal deposits. The State may deposit non-Federal funds, 
including such funds from enrollees, providers or other third parties 
for standard health plan coverage, into its BHP trust fund. Upon 
deposit, such funds will be considered BHP trust funds, must remain in 
the BHP trust fund and meet the standards described in paragraphs (c) 
and (d) of this section.
    (c) Allowable trust fund expenditures. BHP trust funds may only be 
used to:
    (1) Reduce premiums and cost sharing for eligible individuals 
enrolled in standard health plans under BHP; or
    (2) Provide additional benefits for eligible individuals enrolled in 
standard health plans as determined by the State.
    (d) Limitations. BHP trust funds may not be expended for any purpose 
other than those specified in paragraph (c) of this section. In 
addition, BHP trust funds may not be used for other purposes including 
but not limited to:
    (1) Determining the amount of non-Federal funds for the purposes of 
meeting matching or expenditure requirements for Federal funding;
    (2) Program administration of BHP or any other program;

[[Page 1007]]

    (3) Payment to providers not associated with BHP services or 
requirements; or
    (4) Coverage for individuals not eligible for BHP.
    (e) Year-to-year carryover of trust funds. A State may maintain a 
surplus, or reserve, of funds in its trust through the carryover of 
unexpended funds from year-to-year. Expenditures from this surplus must 
be made in accordance with paragraphs (b) and (c) of this section.



Sec. 600.710  Fiscal policies and accountability.

    The BHP administering agency must assure the fiscal policies and 
accountability set forth in paragraphs (a) through (g) of this section. 
This assurance must be reflected in the BHP Blueprint.
    (a) Accounting records. Maintain an accounting system and supporting 
fiscal records to assure that the BHP trust funds are maintained and 
expended in accord with applicable Federal requirements, such as OMB 
Circulars A-87 and A-133.
    (b) Annual certification. Obtain an annual certification from the 
BHP trustees, the State's chief financial officer, or designee, 
certifying all of the following:
    (1) The State's BHP trust fund financial statements for the fiscal 
year.
    (2) The BHP trust funds are not being used as the non-Federal share 
for purposes of meeting any matching or expenditure requirement of any 
Federally-funded program.
    (3) The use of BHP trust funds is in accordance with Federal 
requirements consistent with those specified for the administration and 
provision of the program.
    (c) Independent audit. Conduct an independent audit of BHP trust 
fund expenditures, consistent with the standards set forth in chapter 3 
of the Government Accountability Office's Government Auditing Standards, 
over a 3-year period to determine that the expenditures made during the 
3-year period were allowable as described in Sec. 600.705(b) and in 
accord with other applicable Federal requirements. The independent audit 
may be conducted as a sub-audit of the single state audit conducted in 
accordance with OMB Circular A-133, and must follow the cost accounting 
principles in OMB Circular A-87.
    (d) Annual reports. Publish annual reports on the use of funds, 
including a separate line item that tracks the use of funds described in 
Sec. 600.705(e) to further reduce premiums and cost sharing, or for the 
provision of additional benefits within 10 days of approval by the 
trustees. If applicable for the reporting year, the annual report must 
also contain the findings for the audit conducted in accordance with 
paragraph (c) of this section.
    (e) Restitution. Establish and maintain BHP trust fund restitution 
procedures.
    (f) Record retention. Retain records for 3 years from date of 
submission of a final expenditure report.
    (g) Record retention related to audit findings. If any litigation, 
claim, financial management review, or audit is started before the 
expiration of the 3-year period, the records shall be retained until all 
litigation, claims or audit findings involving the records have been 
resolved and final action taken.



Sec. 600.715  Corrective action, restitution, and disallowance of
questioned BHP transactions.

    (a) Corrective action. When a question has been raised concerning 
the authority for BHP trust fund expenditures in an OIG report, other 
HHS compliance review, State audit or otherwise, the BHP trustees and 
the State shall review the issues and develop a written response no 
later than 60 days upon receipt of such a report, unless otherwise 
specified in the report, review or audit. To the extent determined 
necessary in that review, the BHP trustees and State shall implement 
changes to fiscal procedures to ensure proper use of trust fund 
resources.
    (b) Restitution. To the extent that the State and BHP trustees 
determine that BHP trust funds may not have been properly spent, they 
must ensure restitution to the BHP trust fund of the funds in question. 
Restitution may be made directly by the BHP trustees, by the State, or 
by a liable third party. The State or the BHP trustees may

[[Page 1008]]

enter into indemnification agreements assigning liability for 
restitution of funds to the BHP trust fund.
    (c) Timing of restitution. Restitution to the BHP trust fund for any 
unallowable expenditure may occur in a lump sum amount, or in equal 
installment amounts. Restitution to the BHP trust fund cannot exceed a 
2-year period from the date of the written response in accordance with 
paragraph (a) of this section.
    (d) HHS disallowance of improper BHP trust fund expenditures. The 
State shall return to HHS the amount of federal BHP funding that HHS has 
determined was expended for unauthorized purposes, when no provision has 
been made to restore the funding to the BHP trust fund in accordance 
with paragraph (b) of this section (unless the restitution does not 
comply with the timing conditions described in paragraphs (c) of this 
section). When HHS determines that federal BHP funding is not allowable, 
HHS will provide written notice to the state and BHP Trustees 
containing:
    (1) The date or dates of the improper expenditures from the BHP 
trust fund;
    (2) A brief written explanation of the basis for the determination 
that the expenditures were improper; and
    (3) Procedures for administrative reconsideration of the 
disallowance based on a final determination.
    (e) Administrative reconsideration of BHP trust fund disallowances. 
(1) BHP Trustees or the State may request reconsideration of a 
disallowance within 60 days after receipt of the disallowance notice 
described in paragraph (d)(1) of this section by submitting a written 
request for review, along with any relevant evidence, documentation, or 
explanation, to HHS.
    (2) After receipt of a reconsideration request, if the Secretary (or 
a designated hearing officer) determines that further proceedings would 
be warranted, the Secretary may issue a request for further information 
by a specific date, or may schedule a hearing to obtain further evidence 
or argument.
    (3) The Secretary, or designee, shall issue a final decision within 
90 days after the later of the date of receipt of the reconsideration 
request or date of the last scheduled proceeding or submission.
    (f) Return of disallowed BHP funding. Disallowed federal BHP funding 
must be returned to HHS within 60 days after the later of the date of 
the disallowance notice or the final administrative reconsideration 
upholding the disallowance. Such repayment cannot be made from BHP trust 
funds, but must be made with other, non-Federal funds.

                        PARTS 601	699 [RESERVED]

[[Page 1009]]



CHAPTER V--OFFICE OF INSPECTOR GENERAL-HEALTH CARE, DEPARTMENT OF HEALTH 
                           AND HUMAN SERVICES




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


  Editorial Note: Nomenclature changes to chapter V appear at 66 FR 
39452, July 31, 2001, and 67 FR 36540, May 24, 2002.

                    SUBCHAPTER A--GENERAL PROVISIONS
Part                                                                Page
1000            Introduction; general definitions...........        1011
                      SUBCHAPTER B--OIG AUTHORITIES
1001            Program integrity--Medicare and State health 
                    care programs...........................        1015
1002            Program integrity--State-initiated 
                    exclusions from Medicaid................        1077
1003            Civil money penalties, assessments and 
                    exclusions..............................        1081
1004            Imposition of sanctions on health care 
                    practitioners and providers of health 
                    care services by a Quality Improvement 
                    Organization............................        1101
1005            Appeals of exclusions, civil money penalties 
                    and assessments.........................        1110
1006            Investigational inquiries...................        1119
1007            State Medicaid fraud control units..........        1120
1008            Advisory opinions by the OIG................        1130
1009-1099       [Reserved]

[[Page 1011]]



                     SUBCHAPTER A_GENERAL PROVISIONS





PART 1000_INTRODUCTION; GENERAL DEFINITIONS--Table of Contents



                     Subpart A_Review of Regulations

Sec.
1000.1 Retrospective Review of Existing Regulations
1000.2-1000.5 [Reserved]

                          Subpart B_Definitions

1000.10 General definitions.

    Authority: 42 U.S.C. 1320 and 1395hh.

    Source: 51 FR 34766, Sept. 30, 1986, unless otherwise noted.



                     Subpart A_Review of Regulations

    Effective Date Note: At 86 FR 5755, Jan. 19, 2021, subpart A to part 
1000 was added, effective Mar. 22, 2021. The effective date was delayed 
until Mar. 22, 2022, at 86 FR 15404, Mar. 23, 2021.

    Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 6101 note; 42 
U.S.C. 262a; 42 U.S.C. 405(a); 42 U.S.C. 405(b); 42 U.S.C. 405(d); 42 
U.S.C. 405(e); 42 U.S.C. 1302; 42 U.S.C.1320; 42 U.S.C. 1320a-7d(b); 
1320b-10; 42 U.S.C. 1320c-5; 42 U.S.C. 1395cc(b)(2)(D), (E), and (F); 42 
U.S.C. 1395cc(j); 42 U.S.C. 1395dd(d)(1); 42 U.S.C. 1395hh; 42 U.S.C. 
1395mm; 42 U.S.C. 1395nn(g); 42 U.S.C. 1395ss(d); 42 U.S.C. 1395u(j); 42 
U.S.C. 1395u(k); 42 U.S.C. 1395w-104(e)(6); 42 U.S.C. 1395w-141(i)(3); 
42 U.S.C. 1395y(d); 42 U.S.C. 1395y(e); 42 U.S.C. 1396(a)(4)(A); 42 
U.S.C. 1396a(p); 42 U.S.C. 1396a(a)(39); 42 U.S.C. 1396a(a)(41); 42 
U.S.C. 1396a(a)(61); 42 U.S.C. 1396b(a)(6); 42 U.S.C. 1396b(b)(3); 42 
U.S.C. 1396b(i)(2); 42 U.S.C. 1396b(m); 42 U.S.C. 1396b(q); 42 U.S.C. 
1842(j)(1)(D)(iv); 42 U.S.C. 1842(k)(1); 42 U.S.C. 11131(c); 42 U.S.C. 
11137(b)(2).



Sec. 1000.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and shall be deemed to amend all 
regulations issued by the Secretary or his delegates or sub-delegates in 
this chapter.
    (b) For purposes of this section,
    (1) Assess shall refer to a determination by the Department, in 
consultation with other Federal agencies as appropriate, as to whether 
the Sections issued as part of the same rulemaking (and any amendments 
or additions that may have been added thereafter) currently have a 
significant economic impact upon a substantial number of small entities.
    (2) Review shall refer to a process conducted by the Department, in 
consultation with other Federal agencies as appropriate, the purpose of 
which shall be to determine whether Sections that were issued as part of 
the same rulemaking (and any amendments or additions that may have been 
issued thereafter) should be continued without change, or should be 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize any significant economic impact of the 
Sections upon a substantial number of small entities.
    (3) Section (when capitalized) shall mean a section of the Code of 
Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR 
2.14 is another Section (see 1 CFR 21.11).
    (4) Year of the Section's promulgation shall mean the year the 
Section first became effective, irrespective of whether it was 
subsequently amended.
    (5) Significant economic impact upon a substantial number of small 
entities shall have the meaning of that term in section 610 of title 5 
of the United States Code.
    (c)(1) Unless a Section expires earlier or is rescinded, all 
Sections issued by the Secretary or his delegates or sub-delegates in 
this chapter shall expire at the end of:
    (i) Five calendar years after the year that this section first 
becomes effective;
    (ii) Ten calendar years after the year of the Section's 
promulgation; or
    (iii) Ten calendar years after the last year in which the Department 
assessed and (if review of the Section is required pursuant to paragraph 
(d) of this section) reviewed the Section, whichever is latest.
    (2) The last year in which the Department assessed and (if review of 
the Section is required) reviewed the Section shall be the year during 
which the findings of the assessment and (if required) the review of a 
Section are published in the Federal Register pursuant to paragraph (f) 
of this section.

[[Page 1012]]

    (3)(i) If, prior to the expiration of a Section under paragraph 
(c)(1) of this section, the Secretary makes a written determination that 
the public interest requires continuation of the Section in force beyond 
the date on which the Section would otherwise expire under paragraph 
(c)(1), the Secretary may continue the Section in force one time for a 
period stated in the determination, which shall not exceed one calendar 
year.
    (ii) The Department shall promptly publish in the Federal Register 
any written determination under paragraph (c)(3)(i) of this section.
    (iii) The authority of the Secretary under paragraph (c)(3)(i) of 
this section is not delegable and may be exercised only by the Secretary 
or, when the office of the Secretary is vacant or the Secretary has 
become unable to perform the functions and duties of the office of the 
Secretary, by the individual acting as Secretary in accordance with the 
law.
    (d) The Department is required to review those rulemakings (and any 
amendments or additions that may have been added thereafter) that the 
Department assesses have a significant economic impact upon a 
substantial number of small entities. In reviewing rulemakings to 
minimize any significant economic impact on a substantial number of 
small entities in a manner consistent with the stated objectives of 
applicable statutes, the Department's review shall consider the 
following factors:
    (1) The continued need for the rulemaking, consideration of which 
shall include but not be limited to the extent to which the rulemaking 
defines terms or sets standards used in or otherwise applicable to other 
Federal rules;
    (2) The nature of complaints or comments received concerning the 
rulemaking from the public;
    (3) The complexity of the rulemaking;
    (4) The extent to which the rulemaking overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other 
factors have changed in the area affected by the rulemaking since the 
rulemaking was promulgated or the last time the rulemaking was reviewed 
by the Department; and
    (6) Whether the rulemaking complies with applicable law.
    (e) If the review concludes the Section should be amended or 
rescinded, the Department shall have two years from the date that the 
findings of the review are published in the Federal Register pursuant to 
paragraph (f) of this section to amend or rescind the Section. If the 
Secretary determines that completion of the amendment or rescission is 
not feasible by the established date, he shall so certify in a statement 
published in the Federal Register and may extend the completion date by 
one year at a time, no more than three times, for a total of not more 
than five years (inclusive of the initial two-year period).
    (f) The results of all assessments and reviews conducted in a 
calendar year, including the full underlying analyses and data used to 
support the results (subject to any applicable privilege, protections 
for confidential business information, or explicit legal prohibition on 
disclosure), shall be published in a single document in the Federal 
Register during that calendar year. The document shall be organized in a 
manner that enables both the Department and the public to readily 
determine which assessments and reviews were conducted during that 
calendar year. The document shall also specify the year by which the 
next assessment (and, if required, the next review) of the Section shall 
be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Sections that are prescribed by Federal law, such that the 
Department exercises no discretion as to whether to promulgate the 
Section and as to what is prescribed by the Section. For Sections 
described in this paragraph (g)(1) that are adopted after the effective 
date of this section, the Federal law described in this paragraph (g)(1) 
shall be cited in the notice of adoption.
    (2) Sections whose expiration pursuant to this section would violate 
any other Federal law.
    (3) This section.

[[Page 1013]]

    (4) Sections that involve a military or foreign affairs function of 
the United States.
    (5) Sections addressed solely to internal agency management or 
personnel matters.
    (6) Sections related solely to Federal Government procurement.
    (7) Sections that were issued jointly with other Federal agencies, 
or that were issued in consultation with other agencies because of a 
legal requirement to consult with that other agency.
    (8) 42 CFR 1001.952.
    (h) When the Department commences the process of performing an 
assessment or review, it shall state on a Department-managed website the 
Section(s) whose assessment or review it is commencing. It shall also 
announce once a month in the Federal Register those new assessments or 
reviews that it has commenced in the last month. The Department will 
create a docket on Regulations.gov for each assessment or review that 
the Department is conducting. The public will be able to submit comments 
to the dockets of each rulemaking being assessed or reviewed. Each 
docket shall specify the date by which comments must be received. There 
shall also be a general docket on Regulations.gov where the public can 
submit comments requesting that the Department assess or review a 
Section.
    (i) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or circumstance, 
shall be construed so as to continue to give the maximum effect to the 
provision permitted by law, unless such holding shall be one of utter 
invalidity or unenforceability, in which event the provision shall be 
severable from this section and shall not affect the remainder thereof 
or the application of the provision to persons not similarly situated or 
to dissimilar circumstances.



Sec. Sec. 1000.2-1000.5  [Reserved]



                          Subpart B_Definitions



Sec. 1000.10  General definitions.

    In this chapter, unless the context indicates otherwise--
    Act means the Social Security Act, and titles referred to are titles 
of that Act.
    Administrator means the Administrator, Centers for Medicare & 
Medicaid Services (CMS), formerly the Health Care Financing 
Administration (HCFA).
    ALJ means an Administrative Law Judge.
    Beneficiary means any individual eligible to have benefits paid to 
him or her, or on his or her behalf, under Medicare or any State health 
care program.
    CFR stands for Code of Federal Regulations.
    CMS stands for Centers for Medicare & Medicaid Services, formerly 
the Health Care Financing Administration (HCFA).
    Department means the Department of Health and Human Services (HHS), 
formerly the Department of Health, Education, and Welfare.
    Directly, as used in the definition of ``furnished'' in this 
section, means the provision or supply of items and services by 
individuals or entities (including items and services provided or 
supplied by them but manufactured, ordered, or prescribed by another 
individual or entity) who request or receive payment from Medicare, 
Medicaid, or other Federal health care programs.
    ESRD stands for end-stage renal disease.
    Exclusion means that items and services furnished, ordered, or 
prescribed by a specified individual or entity will not be reimbursed 
under Medicare, Medicaid, or any other Federal health care programs 
until the individual or entity is reinstated by OIG.
    Federal health care program means any plan or program that provides 
health benefits, whether directly, through insurance, or otherwise, 
which is funded directly, in whole or in part, by the United States 
Government (other than the Federal Employees Health Benefits Program), 
or any State health care program as defined in this section.
    FR stands for Federal Register.
    Furnished refers to items or services provided or supplied, directly 
or indirectly, by any individual or entity.

[[Page 1014]]

    HHS stands for the Department of Health and Human Services.
    HHA stands for home health agency.
    HMO stands for health maintenance organization.
    ICF stands for intermediate care facility.
    Indirectly, as used in the definition of ``furnished'' in this 
section, means the provision or supply of items and services 
manufactured, distributed, supplied, or otherwise provided by 
individuals or entities that do not directly request or receive payment 
from Medicare, Medicaid, or other Federal health care programs, but that 
provide items and services to providers, practitioners, or suppliers who 
request or receive payment from these programs for such items or 
services.
    Inspector General means the Inspector General for Health and Human 
Services.
    Medicaid means medical assistance provided under a State plan 
approved under Title XIX of the Act.
    Medicare means the health insurance program for the aged and 
disabled under Title XVIII of the Act.
    OIG means the Office of Inspector General within HHS.
    QIO means a quality improvement organization as that term is used in 
section 1152 of the Act (42 U.S.C. 1320c-1) and its implementing 
regulations.
    Secretary means the Secretary of the Department or his or her 
designees.
    SNF stands for skilled nursing facility.
    Social security benefits means monthly cash benefits payable under 
section 202 or 223 of the Act.
    SSA stands for Social Security Administration.
    State includes the 50 States, the District of Columbia, Puerto Rico, 
the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, 
and the Trust Territory of the Pacific Islands.
    State health care program means:
    (1) A State plan approved under Title XIX of the Act (Medicaid),
    (2) Any program receiving funds under Title V of the Act or from an 
allotment to a State under such title (Maternal and Child Health 
Services Block Grant program),
    (3) Any program receiving funds under subtitle A of Title XX of the 
Act or from any allotment to a State under such subtitle (Block Grants 
to States for Social Services), or
    (4) A State child health plan approved under Title XXI (Children's 
Health Insurance Program).
    United States means the fifty States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, 
and the Northern Mariana Islands.
    U.S.C. stands for United States Code.

[51 FR 34766, Sept. 30, 1986, as amended at 57 FR 3329, Jan. 29, 1992; 
63 FR 46685, Sept. 2, 1998; 66 FR 39452, July 31, 2001; 82 FR 4111, Jan. 
12, 2017]

[[Page 1015]]



                      SUBCHAPTER B_OIG AUTHORITIES





PART 1001_PROGRAM INTEGRITY_MEDICARE AND STATE HEALTH CARE PROGRAMS--
Table of Contents



                      Subpart A_General Provisions

Sec.
1001.1 Scope and purpose.
1001.2 Definitions.

                     Subpart B_Mandatory Exclusions

1001.101 Basis for liability.
1001.102 Length of exclusion.

                     Subpart C_Permissive Exclusions

1001.201 Conviction relating to program or health care fraud.
1001.301 Conviction relating to obstruction of an investigation or 
          audit.
1001.401 Conviction relating to controlled substances.
1001.501 License revocation or suspension.
1001.601 Exclusion or suspension under a Federal or State health care 
          program.
1001.701 Excessive claims or furnishing of unnecessary or substandard 
          items and services.
1001.801 Failure of HMOs and CMPs to furnish medically necessary items 
          and services.
1001.901 False or improper claims.
1001.951 Fraud and kickbacks and other prohibited activities.
1001.952 Exceptions.
1001.1001 Exclusion of entities owned or controlled by a sanctioned 
          person.
1001.1101 Failure to disclose certain information.
1001.1201 Failure to provide payment information.
1001.1301 Failure to grant immediate access.
1001.1401 Violations of PPS corrective action.
1001.1501 Default of health education loan or scholarship obligations.
1001.1551 Exclusion of individuals with ownership or control interest in 
          sanctioned entities.
1001.1552 Making false statements or misrepresentation of material 
          facts.
1001.1601 Violations of the limitations on physician charges.
1001.1701 Billing for services of assistant at surgery during cataract 
          operations.

Appendix A to Subpart C of Part 1001

                Subpart D_Waivers and Effect of Exclusion

1001.1801 Waivers of exclusions.
1001.1901 Scope and effect of exclusion.

                      Subpart E_Notice and Appeals

1001.2001 Notice of intent to exclude.
1001.2002 Notice of exclusion.
1001.2003 Notice of proposal to exclude.
1001.2004 Notice to State agencies.
1001.2005 Notice to State licensing agencies.
1001.2006 Notice to others regarding exclusion.
1001.2007 Appeal of exclusions.

                Subpart F_Reinstatement into the Programs

1001.3001 Timing and method of request for reinstatement.
1001.3002 Basis for reinstatement.
1001.3003 Approval of request for reinstatement.
1001.3004 Denial of request for reinstatement.
1001.3005 Withdrawal of exclusion for reversed or vacated decisions.

    Authority: 42 U.S.C. 1302; 1320a-7; 1320a-7b; 1395u(j); 1395u(k); 
1395w-104(e)(6), 1395y(d); 1395y(e); 1395cc(b)(2)(D), (E), and (F); 
1395hh; 1842(j)(1)(D)(iv), 1842(k)(1), and sec. 2455, Pub. L. 103-355, 
108 Stat. 3327 (31 U.S.C. 6101 note).

    Source: 57 FR 3330, Jan. 29, 1992, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1001.1  Scope and purpose.

    (a) The regulations in this part specify certain bases upon which 
individuals and entities may, or in some cases must, be excluded from 
participation in Medicare, Medicaid and all other Federal health care 
programs. They also state the effect of exclusion, the factors that will 
be considered in determining the length of any exclusion, the provisions 
governing notices of exclusions, and the process by which an excluded 
individual or entity may seek reinstatement into the programs.
    (b) The regulations in this part are applicable to and binding on 
the Office of Inspector General (OIG) in imposing and proposing 
exclusions, as well as to Administrative Law Judges (ALJs), the 
Departmental Appeals Board (DAB), and federal courts in reviewing the 
imposition of exclusions by the OIG (and,

[[Page 1016]]

where applicable, in imposing exclusions proposed by the OIG).

[57 FR 3330, Jan. 29, 1992, as amended at 58 FR 5618, Jan. 22, 1993; 64 
FR 39426, July 22, 1999]



Sec. 1001.2  Definitions.

    For purposes of this part:
    Agent means any person who has express or implied authority to 
obligate or act on behalf of an entity.
    Controlled substance means a drug or other substance, or immediate 
precursor:
    (a) Included in schedules I, II, III, IV or V of part B of 
subchapter I in 21 U.S.C. chapter 13, or
    (b) That is deemed a controlled substance by the law of any State.
    Convicted means that--
    (a) A judgment of conviction has been entered against an individual 
or entity by a Federal, State or local court, regardless of whether:
    (1) There is a post-trial motion or an appeal pending, or
    (2) The judgment of conviction or other record relating to the 
criminal conduct has been expunged or otherwise removed;
    (b) A Federal, State or local court has made a finding of guilt 
against an individual or entity;
    (c) A Federal, State or local court has accepted a plea of guilty or 
nolo contendere by an individual or entity; or
    (d) An individual or entity has entered into participation in a 
first offender, deferred adjudication or other program or arrangement 
where judgment of conviction has been withheld.
    HHS means Department of Health and Human Services.
    Immediate family member means a person's husband or wife; natural or 
adoptive parent; child or sibling; stepparent, stepchild, stepbrother, 
or stepsister; father-, mother-, daughter-, son-, brother- or sister-in-
law; grandparent or grandchild; or spouse of a grandparent or 
grandchild.
    Incarceration means imprisonment or any type of confinement with or 
without supervised release, including, but not limited to, community 
confinement, house arrest and home detention.
    Indirect ownership interest includes an ownership interest through 
any other entities that ultimately have an ownership interest in the 
entity in issue. (For example, an individual has a 10-percent ownership 
interest in the entity at issue if he or she has a 20-percent ownership 
interest in a corporation that wholly owns a subsidiary that is a 50-
percent owner of the entity in issue.)
    Managing employee means an individual (including a general manager, 
business manager, administrator, or director) who exercises operational 
or managerial control over the entity or part thereof or directly or 
indirectly conducts the day-to-day operations of the entity or part 
thereof.
    Member of household means, with respect to a person, any individual 
with whom the person is sharing a common abode as part of a single-
family unit, including domestic employees and others who live together 
as a family unit. A roomer or boarder is not considered a member of 
household.
    Ownership interest means an interest in:
    (1) The capital, the stock, or the profits of the entity, or
    (2) Any mortgage, deed, trust or note, or other obligation secured 
in whole or in part by the property or assets of the entity.
    Ownership or control interest means, with respect to an entity, a 
person who
    (1) Has a direct or an indirect ownership interest (or any 
combination thereof) of 5 percent or more in the entity;
    (2) Is the owner of a whole or part interest in any mortgage, deed 
of trust, note, or other obligation secured (in whole or in part) by the 
entity or any of the property assets thereof, if such interest is equal 
to or exceeds 5 percent of the total property and assets of the entity;
    (3) Is an officer or a director of the entity;
    (4) Is a partner in the entity if the entity is organized as a 
partnership;
    (5) Is an agent of the entity; or
    (6) Is a managing employee of the entity.
    Patient means any individual who is receiving health care items or 
services, including any item or service provided to meet his or her 
physical, mental or

[[Page 1017]]

emotional needs or well-being (including a resident receiving care in a 
facility as described in part 483 of this chapter), whether or not 
reimbursed under Medicare, Medicaid and any other Federal health care 
program and regardless of the location in which such item or service is 
provided.
    Professionally recognized standards of health care are Statewide or 
national standards of care, whether in writing or not, that professional 
peers of the individual or entity whose provision of care is an issue, 
recognize as applying to those peers practicing or providing care within 
a State. When the Department has declared a treatment modality not to be 
safe and effective, practitioners who employ such a treatment modality 
will be deemed not to meet professionally recognized standards of health 
care. This definition will not be construed to mean that all other 
treatments meet professionally recognized standards.
    Sole community physician means a physician who is the only physician 
who provides primary care services to Federal or State health care 
program beneficiaries within a defined service area.
    Sole source of essential specialized services in the community means 
that an individual or entity--
    (1) Is the only practitioner, supplier or provider furnishing 
specialized services in an area designated by the Health Resources 
Services Administration as a health professional shortage area for that 
medical specialty, as listed in 42 part 5, appendices B-F;
    (2) Is a sole community hospital, as defined in Sec. 412.92 of this 
title; or
    (3) Is the only source of specialized services in a reasonably 
defined service area where services by a non-specialist could not be 
substituted for the source without jeopardizing the health or safety of 
beneficiaries.
    State Medicaid Fraud Control Unit means a unit certified by the 
Secretary as meeting the criteria of 42 U.S.C. 1396b(q) and Sec. 
1002.305 of this chapter.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46686, Sept. 2, 1998; 64 
FR 39426, July 22, 1999; 82 FR 4111, Jan. 12, 2017]



                     Subpart B_Mandatory Exclusions



Sec. 1001.101  Basis for liability.

    The OIG will exclude any individual or entity that--
    (a) Has been convicted of a criminal offense related to the delivery 
of an item or service under Medicare or a State health care program, 
including the performance of management or administrative services 
relating to the delivery of items or services under any such program;
    (b) Has been convicted, under Federal or State law, of a criminal 
offense related to the neglect or abuse of a patient, in connection with 
the delivery of a health care item or service, including any offense 
that the OIG concludes entailed, or resulted in, neglect or abuse of 
patients (the delivery of a health care item or service includes the 
provision of any item or service to an individual to meet his or her 
physical, mental or emotional needs or well-being, whether or not 
reimbursed under Medicare, Medicaid or any Federal health care program);
    (c) Has been convicted, under Federal or State law, of a felony that 
occurred after August 21, 1996, relating to fraud, theft, embezzlement, 
breach of fiduciary responsibility, or other financial misconduct--
    (1) In connection with the delivery of a health care item or 
service, including the performance of management or administrative 
services relating to the delivery of such items or services, or
    (2) With respect to any act or omission in a health care program 
(other than Medicare and a State health care program) operated by, or 
financed in whole or in part, by any Federal, State or local government 
agency; or
    (d) Has been convicted, under Federal or State law, of a felony that 
occurred after August 21, 1996 relating to the unlawful manufacture, 
distribution, prescription or dispensing of a controlled substance, as 
defined under Federal or State law. This applies to any individual or 
entity that--
    (1) Is, or has ever been, a health care practitioner, provider, or 
supplier or furnished or furnishes items or services;
    (2) Holds, or has held, a direct or an indirect ownership or control 
interest

[[Page 1018]]

in an entity that furnished or furnishes items or services or is, or has 
ever been, an officer, director, agent, or managing employee of such an 
entity; or
    (3) Is, or has ever been, employed in any capacity in the health 
care industry.

[63 FR 46686, Sept. 2, 1998, as amended at 67 FR 11932, Mar. 18, 2002; 
82 FR 4112, Jan. 12, 2017]



Sec. 1001.102  Length of exclusion.

    (a) No exclusion imposed in accordance with Sec. 1001.101 will be 
for less than 5 years.
    (b) Any of the following factors may be considered to be aggravating 
and a basis for lengthening the period of exclusion--
    (1) The acts resulting in the conviction, or similar acts, caused, 
or were intended to cause, a financial loss to a government agency or 
program or to one or more other entities of $50,000 or more. (The entire 
amount of financial loss to such government agencies or programs or to 
other entities, including any amounts resulting from similar acts not 
adjudicated, will be considered regardless of whether full or partial 
restitution has been made);
    (2) The acts that resulted in the conviction, or similar acts, were 
committed over a period of one year or more;
    (3) The acts that resulted in the conviction, or similar acts, had a 
significant adverse physical, mental or financial impact on one or more 
program beneficiaries or other individuals;
    (4) In convictions involving patient abuse or neglect, the action 
that resulted in the conviction was premeditated, was part of a 
continuing pattern of behavior, or consisted of non-consensual sexual 
acts;
    (5) The sentence imposed by the court included incarceration;
    (6) The convicted individual or entity has a prior criminal, civil 
or administrative sanction record;
    (7) The individual or entity has previously been convicted of a 
criminal offense involving the same or similar circumstances;
    (8) The individual or entity has been convicted of other offenses 
besides those that formed the basis for the exclusion; or
    (9) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or board 
if the adverse action is based on the same set of circumstances that 
serves as the basis for the imposition of the exclusion.
    (c) Only if any of the aggravating factors set forth in paragraph 
(b) of this section justifies an exclusion longer than 5 years, may 
mitigating factors be considered as a basis for reducing the period of 
exclusion to no less than 5 years. Only the following factors may be 
considered mitigating--
    (1) In the case of an exclusion under Sec. 1001.101(a), whether the 
individual or entity was convicted of three or fewer misdemeanor 
offenses and the entire amount of financial loss (both actual loss and 
intended loss) to Medicare or any other Federal, State, or local 
governmental health care program due to the acts that resulted in the 
conviction, and similar acts, is less than $5,000;
    (2) The record in the criminal proceedings, including sentencing 
documents, demonstrates that the court determined that the individual 
had a mental, emotional or physical condition before or during the 
commission of the offense that reduced the individual's culpability; or
    (3) The individual's or entity's cooperation with Federal or State 
officials resulted in--
    (i) Others being convicted or excluded from Medicare, Medicaid and 
all other Federal health care programs,
    (ii) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses, or
    (iii) The imposition against anyone of a civil money penalty or 
assessment under part 1003 of this chapter.
    (d) In the case of an exclusion under this subpart, based on a 
conviction occurring on or after August 5, 1997, an exclusion will be--
    (1) For not less than 10 years if the individual has been convicted 
on one previous occasion of one or more offenses for which an exclusion 
may be effected under section 1128(a) of the

[[Page 1019]]

Act. (The aggravating and mitigating factors in paragraphs (b) and (c) 
of this section can be used to impose a period of time in excess of the 
10-year mandatory exclusion); or
    (2) Permanent if the individual has been convicted on two or more 
previous occasions of one or more offenses for which an exclusion may be 
effected under section 1128(a) of the Act.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46686, Sept. 2, 1998; 63 
FR 57918, Oct. 29, 1998; 64 FR 39426, July 22, 1999; 67 FR 11932, Mar. 
18, 2002; 82 FR 4112, Jan. 12, 2017]



                     Subpart C_Permissive Exclusions



Sec. 1001.201  Conviction relating to program or health care fraud.

    (a) Circumstance for exclusion. The OIG may exclude an individual or 
entity convicted under Federal or State law of--
    (1) A misdemeanor relating to fraud, theft, embezzlement, breach of 
fiduciary responsibility, or other financial misconduct--
    (i) In connection with the delivery of any health care item or 
service, including the performance of management or administrative 
services relating to the delivery of such items or services, or
    (ii) With respect to any act or omission in a health care program, 
other than Medicare and a State health care program, operated by, or 
financed in whole or in part by, any Federal, State or local government 
agency; or
    (2) Fraud, theft, embezzlement, breach of fiduciary responsibility, 
or other financial misconduct with respect to any act or omission in a 
program, other than a health care program, operated by or financed in 
whole or in part by any Federal, State or local government agency.
    (b) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will be for a period of 3 years, unless aggravating or 
mitigating factors listed in paragraphs (b)(2) and (b)(3) of this 
section form a basis for lengthening or shortening that period.
    (2) Any of the following factors may be considered to be aggravating 
and a basis for lengthening the period of exclusion--
    (i) The acts resulting in the conviction, or similar acts, caused or 
reasonably could have been expected to cause, a financial loss of 
$50,000 or more to a government agency or program or to one or more 
other entities or had a significant financial impact on program 
beneficiaries or other individuals. (The entire amount of financial loss 
will be considered, including any amounts resulting from similar acts 
not adjudicated, regardless of whether full or partial restitution has 
been made);
    (ii) The acts that resulted in the conviction, or similar acts, were 
committed over a period of one year or more;
    (iii) The acts that resulted in the conviction, or similar acts, had 
a significant adverse physical or mental impact on one or more program 
beneficiaries or other individuals;
    (iv) The sentence imposed by the court included incarceration;
    (v) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing; or
    (vi) Whether the individual or entity has been convicted of other 
offenses besides those that formed the basis for the exclusion; or
    (vii) Whether the individual or entity has been the subject of any 
other adverse action by any Federal, State, or local government agency 
or board if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.
    (3) Only the following factors may be considered as mitigating and a 
basis for reducing the period of exclusion--
    (i) The individual or entity was convicted of three or fewer 
offenses, and the entire amount of financial loss (both actual loss and 
reasonably expected loss) to a government agency or program or to other 
individuals or entities due to the acts that resulted in the conviction 
and similar acts is less than $5,000;
    (ii) The record in the criminal proceedings, including sentencing 
documents, demonstrates that the court determined that the individual 
had a mental, emotional, or physical condition, before or during the 
commission of the offense, that reduced the individual's culpability; or

[[Page 1020]]

    (iii) The individual's or entity's cooperation with Federal or State 
officials resulted in--
    (A) Others being convicted or excluded from Medicare, Medicaid or 
any of the other Federal health care programs, or
    (B) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses, or
    (C) The imposition of a civil money penalty against others; or
    (iv) Alternative sources of the type of health care items or 
services furnished by the individual or entity are not available.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46687, Sept. 2, 1998; 64 
FR 39426, July 22, 1999; 67 FR 11932, Mar. 18, 2002; 67 FR 21579, May 1, 
2002; 82 FR 4112, Jan. 12, 2017]



Sec. 1001.301  Conviction relating to obstruction of an investigation 
or audit.

    (a) Circumstance for exclusion. The OIG may exclude an individual or 
entity that has been convicted, under Federal or State law, in 
connection with the interference with or obstruction of any 
investigation or audit related to--
    (1) Any offense described in Sec. 1001.101 or Sec. 1001.201; or
    (2) The use of funds received, directly or indirectly, from any 
Federal health care program.
    (b) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will be for a period of three years, unless aggravating or 
mitigating factors listed in paragraphs (b)(2) and (3) of this section 
form the basis for lengthening or shortening that period.
    (2) Any of the following factors may be considered to be aggravating 
and a basis for lengthening the period of exclusion--
    (i) The interference or obstruction caused the expenditure of 
significant additional time or resources;
    (ii) The interference or obstruction had a significant adverse 
physical or mental impact on one or more program beneficiaries or other 
individuals;
    (iii) The interference or obstruction also affected a civil or 
administrative investigation;
    (iv) The sentence imposed by the court included incarceration;
    (v) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing; or
    (vi) Whether the individual or entity has been convicted of other 
offenses besides those that formed the basis for the exclusion;
    (vii) Whether the individual or entity has been the subject of any 
other adverse action by any Federal, State or local government agency or 
board if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion; or
    (viii) The acts resulting in the conviction, or similar acts, 
caused, or reasonably could have been expected to cause, a financial 
loss of $50,000 or more to a government agency or program or to one or 
more other entities or had a significant financial impact on program 
beneficiaries or other individuals. (The entire amount of financial loss 
or intended loss identified in the investigation or audit will be 
considered, including any amounts resulting from similar acts not 
adjudicated, regardless of whether full or partial restitution has been 
made).
    (3) Only the following factors may be considered as mitigating and a 
basis for reducing the period of exclusion--
    (i) The record of the criminal proceedings, including sentencing 
documents, demonstrates that the court determined that the individual 
had a mental, emotional, or physical condition, before or during the 
commission of the offense, that reduced the individual's culpability; or
    (ii) The individual's or entity's cooperation with Federal or State 
officials resulted in--
    (A) Others being convicted or excluded from Medicare, Medicaid and 
all other Federal health care programs,
    (B) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses, or
    (C) The imposition of a civil money penalty against others; or

[[Page 1021]]

    (iii) Alternative sources of the type of health care items or 
services furnished by the individual or entity are not available.

[57 FR 3329, Jan. 29, 1992; 57 FR 9669, Mar. 20, 1992; 63 FR 46687, 
Sept. 2, 1998; 64 FR 39426, July 22, 1999; 82 FR 4112, Jan. 12, 2017]



Sec. 1001.401  Conviction relating to controlled substances.

    (a) Circumstance for exclusion. The OIG may exclude an individual or 
entity convicted under Federal or State law of a misdemeanor relating to 
the unlawful manufacture, distribution, prescription, or dispensing of a 
controlled substance, as defined under Federal or State law. This 
section applies to any individual or entity that--
    (1) Is, or has ever been, a health care practitioner, provider, or 
supplier or furnished or furnishes items or services;
    (2) Holds, or held, a direct or indirect ownership or control 
interest in an entity that furnished or furnishes items or services or 
is or has ever been an officer, director, agent, or managing employee of 
such an entity; or
    (3) Is, or has ever been, employed in any capacity in the health 
care industry.
    (b) For purposes of this section, the definition of controlled 
substance will be the definition that applies to the law forming the 
basis for the conviction.
    (c) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will be for a period of 3 years, unless aggravating or 
mitigating factors listed in paragraphs (c)(2) and (3) of this section 
form a basis for lengthening or shortening that period.
    (2) Any of the following factors may be considered to be aggravating 
and to be a basis for lengthening the period of exclusion--
    (i) The acts that resulted in the conviction or similar acts were 
committed over a period of one year or more;
    (ii) The acts that resulted in the conviction or similar acts had a 
significant adverse mental, physical or financial impact on program 
beneficiaries or other individuals or the Medicare, Medicaid or other 
Federal health care programs;
    (iii) The sentence imposed by the court included incarceration;
    (iv) Whether the individual or entity has a documented history of 
criminal, civil, or administrative wrongdoing;
    (v) Whether the individual or entity has been convicted of other 
offenses besides those that formed the basis for the exclusion; or
    (vi) Whether the individual or entity has been the subject of any 
other adverse action by any Federal, State, or local government agency 
or board if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.
    (3) Only the following factor may be considered to be mitigating and 
to be a basis for shortening the period of exclusion: The individual's 
or entity's cooperation with Federal or State officials resulted in--
    (i) Others being convicted or excluded from Medicare, Medicaid, and 
any other Federal health care program;
    (ii) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses; or
    (iii) The imposition of a civil money penalty against others.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46687, Sept. 2, 1998; 64 
FR 39426, July 22, 1999; 82 FR 4113, Jan. 12, 2017]



Sec. 1001.501  License revocation or suspension.

    (a) Circumstance for exclusion. The OIG may exclude an individual or 
entity that has--
    (1) Had a license to provide health care revoked or suspended by any 
State licensing authority, or has otherwise lost such a license 
(including the right to apply for or renew such a license), for reasons 
bearing on the individual's or entity's professional competence, 
professional performance or financial integrity; or
    (2) Has surrendered such a license while a formal disciplinary 
proceeding concerning the individual's or entity's professional 
competence, professional performance or financial integrity was pending 
before a State licensing authority.

[[Page 1022]]

    (b) Length of exclusion. (1) Except as provided in paragraph (b)(2) 
of this section, an exclusion imposed in accordance with this section 
will not be for a period of time less than the period during which an 
individual's or entity's license is revoked, suspended, or otherwise not 
in effect as a result of, or in connection with, a State licensing 
agency action.
    (2) Any of the following factors may be considered aggravating and a 
basis for lengthening the period of exclusion--
    (i) The acts that resulted in the revocation, suspension or loss of 
the individual's or entity's license to provide health care had or could 
have had a significant adverse physical, emotional or financial impact 
on one or more program beneficiaries or other individuals;
    (ii) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing;
    (iii) The acts, or similar acts, had or could have had a significant 
adverse impact on the financial integrity of the programs; or
    (iv) The individual or entity has been the subject of any other 
adverse action by any other Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.
    (3) Only if any of the aggravating factors listed in paragraph 
(b)(2) of this section justifies a longer exclusion may a mitigating 
factor be considered as a basis for reducing the period of exclusion to 
a period not less than that set forth in paragraph (b)(1) of this 
section. Only the following factor may be considered mitigating: The 
individual's or entity's cooperation with a State licensing authority 
resulted in--
    (i) The sanctioning of other individuals or entities, or
    (ii) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses.
    (4) When an individual or entity has been excluded under this 
section, the OIG will consider a request for reinstatement in accordance 
with Sec. 1001.3001 if:
    (i) The individual or entity obtains the license in the State where 
the license was originally revoked, suspended, surrendered, or otherwise 
lost or
    (ii) The individual meets the conditions for early reinstatement set 
forth in paragraph (c) of this section.
    (c) Consideration of early reinstatement. (1) If an individual or 
entity that is excluded in accordance with this section fully and 
accurately discloses the circumstances surrounding the action that 
formed the basis for the exclusion to a licensing authority of a 
different State or to a different licensing authority in the same State 
and that licensing authority grants the individual or entity a new 
health care license or has decided to take no adverse action as to a 
currently held health care license, the OIG will consider a request for 
early reinstatement. The OIG will consider the following factors in 
determining whether a request for early reinstatement under this 
paragraph (c)(1) will be granted:
    (i) The circumstances that formed the basis for the exclusion;
    (ii) Whether the second licensing authority is in a state that is 
not the individual's primary place of practice;
    (iii) Evidence that the second licensing authority was aware of the 
circumstances surrounding the action that formed the basis for the 
exclusion;
    (iv) Whether the individual has demonstrated that he or she has 
satisfactorily resolved any underlying problem that caused or 
contributed to the basis for the initial licensing action;
    (v) The benefits to the Federal health care programs and program 
beneficiaries of early reinstatement;
    (vi) The risks to the Federal health care programs and program 
beneficiaries of early reinstatement;
    (vii) Any additional or pending license actions in any State;
    (viii) Any ongoing investigations involving the individual; and
    (ix) All the factors set forth in Sec. 1001.3002(b).
    (2) If an exclusion has been imposed under this section and the 
individual does not have a valid health care license of any kind in any 
State, that individual may request the OIG to consider whether he or she 
may be eligible

[[Page 1023]]

for early reinstatement. The OIG will consider the following factors in 
determining whether a request for early reinstatement under this 
paragraph (c)(2) will be granted:
    (i) The length of time the individual has been excluded. The OIG 
will apply a presumption against early reinstatement under paragraph 
(c)(2) of this section if the person has been excluded for less than 3 
years; however, if the revocation or suspension on which the exclusion 
is based was for a set period longer than 3 years, the presumption 
against early reinstatement will be coterminous with the period set by 
the licensing board;
    (ii) The circumstances that formed the basis for the exclusion;
    (iii) Whether the individual has demonstrated that he or she has 
satisfactorily resolved any underlying problem that caused or 
contributed to the basis for the initial licensing action;
    (iv) The benefits to the Federal health care programs and program 
beneficiaries of early reinstatement;
    (v) The risks to the Federal health care programs and program 
beneficiaries of early reinstatement;
    (vi) Any additional or pending license actions in any State;
    (vii) Any ongoing investigations involving the individual; and
    (viii) All the factors set forth in Sec. 1001.3002(b).
    (3) Notwithstanding paragraphs (c)(1) and (2) of this section, if an 
individual's license revocation or suspension was for reasons related to 
patient abuse or neglect, the OIG will not consider an application for 
early reinstatement.
    (4) Except for Sec. 1001.3002(a)(1)(i), all the provisions of 
subpart F (Sec. Sec. 1001.3001 through 1001.3005) apply to early 
reinstatements under this section.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46688, Sept. 2, 1998; 82 
FR 4113, Jan. 12, 2017]



Sec. 1001.601  Exclusion or suspension under a Federal or State
health care program.

    (a) Circumstance for exclusion. (1) The OIG may exclude an 
individual or entity suspended or excluded from participation, or 
otherwise sanctioned, under--
    (i) Any Federal program involving the provision of health care, or
    (ii) A State health care program, for reasons bearing on the 
individual's or entity's professional competence, professional 
performance or financial integrity.
    (2) The term ``or otherwise sanctioned'' in paragraph (a)(1) of this 
section is intended to cover all actions that limit the ability of a 
person to participate in the program at issue regardless of what such an 
action is called, and includes situations where an individual or entity 
voluntarily withdraws from a program to avoid a formal sanction.
    (b) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will not be for a period of time less than the period 
during which the individual or entity is excluded or suspended from a 
Federal or State health care program.
    (2) Any of the following factors may be considered aggravating and a 
basis for lengthening the period of exclusion--
    (i) The acts that resulted in the exclusion, suspension or other 
sanction under Medicare, Medicaid and all other Federal health care 
programs had, or could have had, a significant adverse impact on Federal 
or State health care programs or the beneficiaries of those programs or 
other individuals;
    (ii) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing; or
    (iii) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.
    (3) Only if any of the aggravating factors listed in paragraph 
(b)(2) of this section justifies a longer exclusion may a mitigating 
factor be considered as a basis for reducing the period of exclusion to 
a period not less than that set forth in paragraph (b)(1) of this 
section. Only the following factor may be considered mitigating: The 
individual's or entity's cooperation with Federal or State officials 
resulted in--
    (i) The sanctioning of other individuals or entities, or

[[Page 1024]]

    (ii) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses.
    (4) If the individual or entity is eligible to apply for 
reinstatement in accordance with Sec. 1001.3001 and the sole reason why 
the State or Federal health care program denied reinstatement to that 
program is the existing exclusion imposed by the OIG as a result of the 
original State or Federal health care program action, the OIG will 
consider a request for reinstatement.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46688, Sept. 2, 1998; 82 
FR 4114, Jan. 12, 2017]



Sec. 1001.701  Excessive claims or furnishing of unnecessary or 
substandard items and services.

    (a) Circumstance for exclusion. The OIG may exclude an individual or 
entity that has--
    (1) Submitted, or caused to be submitted, bills or requests for 
payments under Medicare or any of the State health care programs 
containing charges or costs for items or services furnished that are 
substantially in excess of such individual's or entity's usual charges 
or costs for such items or services; or
    (2) Furnished, or caused to be furnished, to patients (whether or 
not covered by Medicare or any of the State health care programs) any 
items or services substantially in excess of the patient's needs, or of 
a quality that fails to meet professionally recognized standards of 
health care.
    (b) The OIG's determination under paragraph (a)(2) of this section--
that the items or services furnished were excessive or of unacceptable 
quality--will be made on the basis of information, including sanction 
reports, from the following sources:
    (1) The QIO for the area served by the individual or entity;
    (2) State or local licensing or certification authorities;
    (3) Fiscal agents or contractors, or private insurance companies;
    (4) State or local professional societies; or
    (5) Any other sources deemed appropriate by the OIG.
    (c) Exceptions. An individual or entity will not be excluded for--
    (1) Submitting, or causing to be submitted, bills or requests for 
payment that contain charges or costs substantially in excess of usual 
charges or costs when such charges or costs are due to unusual 
circumstances or medical complications requiring additional time, 
effort, expense or other good cause; or
    (2) Furnishing, or causing to be furnished, items or services in 
excess of the needs of patients, when the items or services were ordered 
by a physician or other authorized individual, and the individual or 
entity furnishing the items or services was not in a position to 
determine medical necessity or to refuse to comply with the order of the 
physician or other authorized individual.
    (d) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will be for a period of 3 years, unless aggravating or 
mitigating factors set forth in paragraphs (d)(2) and (d)(3) of this 
section form a basis for lengthening or shortening the period. In no 
case may the period be shorter than 1 year for any exclusion taken in 
accordance with paragraph (a)(2) of this section.
    (2) Any of the following factors may be considered aggravating and a 
basis for lengthening the period of exclusion--
    (i) The violations were serious in nature, and occurred over a 
period of one year or more;
    (ii) The violations had a significant adverse physical, mental or 
financial impact on program beneficiaries or other individuals;
    (iii) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing;
    (iv) The violation resulted in financial loss to Medicare, Medicaid, 
or any other Federal health care program of $15,000 or more; or
    (v) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.

[[Page 1025]]

    (3) Only the following factor may be considered mitigating and a 
basis for reducing the period of exclusion: Whether there were few 
violations and they occurred over a short period of time.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46688, Sept. 2, 1998; 82 
FR 4114, Jan. 12, 2017]



Sec. 1001.801  Failure of HMOs and CMPs to furnish medically necessary
items and services.

    (a) Circumstances for exclusion. The OIG may exclude an entity--
    (1) That is a--
    (i) Health maintenance organization (HMO), as defined in section 
1903(m) of the Act, providing items or services under a State Medicaid 
Plan;
    (ii) Primary care case management system providing services, in 
accordance with a waiver approved under section 1915(b)(1) of the Act; 
or
    (iii) HMO or competitive medical plan providing items or services in 
accordance with a risk-sharing contract under section 1876 of the Act;
    (2) That has failed substantially to provide medically necessary 
items and services that are required under a plan, waiver or contract 
described in paragraph (a)(1) of this section to be provided to 
individuals covered by such plan, waiver or contract; and
    (3) Where such failure has adversely affected or has a substantial 
likelihood of adversely affecting covered individuals.
    (b) The OIG's determination under paragraph (a)(2) of this section--
that the medically necessary items and services required under law or 
contract were not provided--will be made on the basis of information, 
including sanction reports, from the following sources:
    (1) The QIO or other quality assurance organization under contract 
with a State Medicaid plan for the area served by the HMO or competitive 
medical plan;
    (2) State or local licensing or certification authorities;
    (3) Fiscal agents or contractors, or private insurance companies;
    (4) State or local professional societies;
    (5) CMS's HMO compliance office; or
    (6) Any other sources deemed appropriate by the OIG.
    (c) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will be for a period of 3 years, unless aggravating or 
mitigating factors set forth in paragraphs (c)(2) and (c)(3) of this 
section form a basis for lengthening or shortening the period.
    (2) Any of the following factors may be considered aggravating and a 
basis for lengthening the period of exclusion--
    (i) The entity failed to provide a large number or a variety of 
items or services;
    (ii) The failures occurred over a lengthy period of time;
    (iii) The entity's failure to provide a necessary item or service 
that had or could have had a serious adverse effect;
    (iv) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing; or
    (v) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.
    (3) Only the following factors may be considered as mitigating and a 
basis for reducing the period of exclusion--
    (i) There were few violations and they occurred over a short period 
of time; or
    (ii) The entity took corrective action upon learning of 
impermissible activities by an employee or contractor.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46688, Sept. 2, 1998; 82 
FR 4114, Jan. 12, 2017]



Sec. 1001.901  False or improper claims.

    (a) Circumstance for exclusion. The OIG may exclude any individual 
or entity that it determines has committed an act described in section 
1128A of the Act. The imposition of a civil money penalty or assessment 
is not a prerequisite for an exclusion under this section.
    (b) Length of exclusion. In determining the length of an exclusion 
imposed in accordance with this section, the OIG will consider the 
following factors--

[[Page 1026]]

    (1) The nature and circumstances surrounding the actions that are 
the basis for liability, including the period of time over which the 
acts occurred, the number of acts, whether there is evidence of a 
pattern and the amount claimed;
    (2) The degree of culpability;
    (3) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing (The lack of any prior 
record is to be considered neutral);
    (4) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion; or
    (5) Other matters as justice may require.
    (c) Limitations. The OIG may not impose an exclusion under this 
section more than 10 years after the date when an act which is described 
in section 1128A of the Act occurred.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46689, Sept. 2, 1998; 82 
FR 4114, Jan. 12, 2017]



Sec. 1001.951  Fraud and kickbacks and other prohibited activities.

    (a) Circumstance for exclusion. (1) Except as provided for in 
paragraph (a)(2)(ii) of this section, the OIG may exclude any individual 
or entity that it determines has committed an act described in section 
1128B(b) of the Act.
    (2) With respect to acts described in section 1128B of the Act, the 
OIG--
    (i) May exclude any individual or entity that it determines has 
knowingly and willfully solicited, received, offered or paid any 
remuneration in the manner and for the purposes described therein, 
irrespective of whether the individual or entity may be able to prove 
that the remuneration was also intended for some other purpose; and
    (ii) Will not exclude any individual or entity if that individual or 
entity can prove that the remuneration that is the subject of the 
exclusion is exempted from serving as the basis for an exclusion.
    (b) Length of exclusion. (1) The following factors will be 
considered in determining the length of exclusion in accordance with 
this section--
    (i) The nature and circumstances of the acts and other similar acts;
    (ii) The nature and extent of any adverse physical, mental, 
financial or other impact the conduct had on program beneficiaries or 
other individuals or the Medicare, Medicaid and all other Federal health 
care programs;
    (iii) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing (The lack of any prior 
record is to be considered neutral);
    (iv) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion; or
    (v) Any other facts bearing on the nature and seriousness of the 
individual's or entity's misconduct.
    (2) It will be considered a mitigating factor if--
    (i) The individual had a documented mental, emotional, or physical 
condition before or during the commission of the prohibited act(s) that 
reduced the individual's culpability for the acts in question; or
    (ii) The individual's or entity's cooperation with Federal or State 
officials resulted in the--
    (A) Sanctioning of other individuals or entities, or
    (B) Imposition of a civil money penalty against others.
    (c) Limitations. The OIG may not impose an exclusion under this 
section more than 10 years after the date when an act which is described 
in section 1128B(b) of the Act occurred.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46689, Sept. 2, 1998; 67 
FR 11933, Mar. 18, 2002; 82 FR 4114, Jan. 12, 2017]



Sec. 1001.952  Exceptions.

    The following payment practices shall not be treated as a criminal 
offense under section 1128B of the Act and shall not serve as the basis 
for an exclusion:
    (a) Investment interests. As used in section 1128B of the Act, 
``remuneration'' does not include any payment

[[Page 1027]]

that is a return on an investment interest, such as a dividend or 
interest income, made to an investor as long as all of the applicable 
standards are met within one of the following three categories of 
entities:
    (1) If, within the previous fiscal year or previous 12 month period, 
the entity possesses more than $50,000,000 in undepreciated net tangible 
assets (based on the net acquisition cost of purchasing such assets from 
an unrelated entity) related to the furnishing of health care items and 
services, all of the following five standards must be met--
    (i) With respect to an investment interest that is an equity 
security, the equity security must be registered with the Securities and 
Exchange Commission under 15 U.S.C. 781 (b) or (g).
    (ii) The investment interest of an investor in a position to make or 
influence referrals to, furnish items or services to, or otherwise 
generate business for the entity must be obtained on terms (including 
any direct or indirect transferability restrictions) and at a price 
equally available to the public when trading on a registered securities 
exchange, such as the New York Stock Exchange or the American Stock 
Exchange, or in accordance with the National Association of Securities 
Dealers Automated Quotation System.
    (iii) The entity or any investor must not market or furnish the 
entity's items or services (or those of another entity as part of a 
cross referral agreement) to passive investors differently than to non-
investors.
    (iv) The entity or any investor (or other individual or entity 
acting on behalf of the entity or any investor in the entity) must not 
loan funds to or guarantee a loan for an investor who is in a position 
to make or influence referrals to, furnish items or services to, or 
otherwise generate business for the entity if the investor uses any part 
of such loan to obtain the investment interest.
    (v) The amount of payment to an investor in return for the 
investment interest must be directly proportional to the amount of the 
capital investment of that investor.
    (2) If the entity possesses investment interests that are held by 
either active or passive investors, all of the following eight 
applicable standards must be met--
    (i) No more than 40 percent of the value of the investment interests 
of each class of investment interests may be held in the previous fiscal 
year or previous 12 month period by investors who are in a position to 
make or influence referrals to, furnish items or services to, or 
otherwise generate business for the entity. (For purposes of paragraph 
(a)(2)(i) of this section, equivalent classes of equity investments may 
be combined, and equivalent classes of debt instruments may be 
combined.)
    (ii) The terms on which an investment interest is offered to a 
passive investor, if any, who is in a position to make or influence 
referrals to, furnish items or services to, or otherwise generate 
business for the entity must be no different from the terms offered to 
other passive investors.
    (iii) The terms on which an investment interest is offered to an 
investor who is in a position to make or influence referrals to, furnish 
items or services to, or otherwise generate business for the entity must 
not be related to the previous or expected volume of referrals, items or 
services furnished, or the amount of business otherwise generated from 
that investor to the entity.
    (iv) There is no requirement that a passive investor, if any, make 
referrals to, be in a position to make or influence referrals to, 
furnish items or services to, or otherwise generate business for the 
entity as a condition for remaining as an investor.
    (v) The entity or any investor must not market or furnish the 
entity's items or services (or those of another entity as part of a 
cross referral agreement) to passive investors differently than to non-
investors.
    (vi) No more than 40 percent of the entity's gross revenue related 
to the furnishing of health care items and services in the previous 
fiscal year or previous 12-month period may come from referrals or 
business otherwise generated from investors.
    (vii) The entity or any investor (or other individual or entity 
acting on behalf of the entity or any investor in the entity) must not 
loan funds to or guarantee a loan for an investor who is in a position 
to make or influence referrals

[[Page 1028]]

to, furnish items or services to, or otherwise generate business for the 
entity if the investor uses any part of such loan to obtain the 
investment interest.
    (viii) The amount of payment to an investor in return for the 
investment interest must be directly proportional to the amount of the 
capital investment (including the fair market value of any pre-
operational services rendered) of that investor.
    (3)(i) If the entity possesses investment interests that are held by 
either active or passive investors and is located in an underserved 
area, all of the following eight standards must be met--
    (A) No more than 50 percent of the value of the investment interests 
of each class of investments may be held in the previous fiscal year or 
previous 12-month period by investors who are in a position to make or 
influence referrals to, furnish items or services to, or otherwise 
generate business for, the entity. (For purposes of paragraph 
(a)(3)(i)(A) of this section, equivalent classes of equity investments 
may be combined, and equivalent classes of debt instruments may be 
combined.)
    (B) The terms on which an investment interest is offered to a 
passive investor, if any, who is in a position to make or influence 
referrals to, furnish items or services to, or otherwise generate 
business for the entity must be no different from the terms offered to 
other passive investors.
    (C) The terms on which an investment interest is offered to an 
investor who is in a position to make or influence referrals to, furnish 
items or services to, or otherwise generate business for the entity must 
not be related to the previous or expected volume of referrals, items or 
services furnished, or the amount of business otherwise generated from 
that investor to the entity.
    (D) There is no requirement that a passive investor, if any, make 
referrals to, be in a position to make or influence referrals to, 
furnish items or services to, or otherwise generate business for the 
entity as a condition for remaining as an investor.
    (E) The entity or any investor must not market or furnish the 
entity's items or services (or those of another entity as part of a 
cross-referral agreement) to passive investors differently than to non-
investors.
    (F) At least 75 percent of the dollar volume of the entity's 
business in the previous fiscal year or previous 12-month period must be 
derived from the service of persons who reside in an underserved area or 
are members of medically underserved populations.
    (G) The entity or any investor (or other individual or entity acting 
on behalf of the entity or any investor in the entity) must not loan 
funds to or guarantee a loan for an investor who is in a position to 
make or influence referrals to, furnish items or services to, or 
otherwise generate business for the entity if the investor uses any part 
of such loan to obtain the investment interest.
    (H) The amount of payment to an investor in return for the 
investment interest must be directly proportional to the amount of the 
capital investment (including the fair market value of any pre-
operational services rendered) of that investor.
    (ii) If an entity that otherwise meets all of the above standards is 
located in an area that was an underserved area at the time of the 
initial investment, but subsequently ceases to be an underserved area, 
the entity will be deemed to comply with paragraph (a)(3)(i) of this 
section for a period equal to the lesser of:
    (A) The current term of the investment remaining after the date upon 
which the area ceased to be an underserved area or
    (B) Three years from the date the area ceased to be an underserved 
area.
    (4) For purposes of paragraph (a) of this section, the following 
terms apply. Active investor means an investor either who is responsible 
for the day-to-day management of the entity and is a bona fide general 
partner in a partnership under the Uniform Partnership Act or who agrees 
in writing to undertake liability for the actions of the entity's agents 
acting within the scope of their agency. Investment interest means a 
security issued by an entity, and may include the following classes of 
investments: shares in a corporation, interests or units in a 
partnership or limited liability company, bonds, debentures, notes, or 
other debt instruments. Investor means an individual or entity

[[Page 1029]]

either who directly holds an investment interest in an entity, or who 
holds such investment interest indirectly by, including but not limited 
to, such means as having a family member hold such investment interest 
or holding a legal or beneficial interest in another entity (such as a 
trust or holding company) that holds such investment interest. Passive 
investor means an investor who is not an active investor, such as a 
limited partner in a partnership under the Uniform Partnership Act, a 
shareholder in a corporation, or a holder of a debt security. 
Underserved area means any defined geographic area that is designated as 
a Medically Underserved Area (MUA) in accordance with regulations issued 
by the Department. Medically underserved population means a Medically 
Underserved Population (MUP) in accordance with regulations issued by 
the Department.
    (b) Space rental. As used in section 1128B of the Act, 
``remuneration'' does not include any payment made by a lessee to a 
lessor for the use of premises, as long as all of the following six 
standards are met--
    (1) The lease agreement is set out in writing and signed by the 
parties.
    (2) The lease covers all of the premises leased between the parties 
for the term of the lease and specifies the premises covered by the 
lease.
    (3) If the lease is intended to provide the lessee with access to 
the premises for periodic intervals of time, rather than on a full-time 
basis for the term of the lease, the lease specifies exactly the 
schedule of such intervals, their precise length, and the exact rent for 
such intervals.
    (4) The term of the lease is for not less than one year.
    (5) The aggregate rental charge is set in advance, is consistent 
with fair market value in arms-length transactions and is not determined 
in a manner that takes into account the volume or value of any referrals 
or business otherwise generated between the parties for which payment 
may be made in whole or in part under Medicare, Medicaid or other 
Federal health care programs.
    (6) The aggregate space rented does not exceed that which is 
reasonably necessary to accomplish the commercially reasonable business 
purpose of the rental. Note that for purposes of paragraph (b) of this 
section, the term fair market value means the value of the rental 
property for general commercial purposes, but shall not be adjusted to 
reflect the additional value that one party (either the prospective 
lessee or lessor) would attribute to the property as a result of its 
proximity or convenience to sources of referrals or business otherwise 
generated for which payment may be made in whole or in part under 
Medicare, Medicaid and all other Federal health care programs.
    (c) Equipment rental. As used in section 1128B of the Act, 
``remuneration'' does not include any payment made by a lessee of 
equipment to the lessor of the equipment for the use of the equipment, 
as long as all of the following six standards are met--
    (1) The lease agreement is set out in writing and signed by the 
parties.
    (2) The lease covers all of the equipment leased between the parties 
for the term of the lease and specifies the equipment covered by the 
lease.
    (3) If the lease is intended to provide the lessee with use of the 
equipment for periodic intervals of time, rather than on a full-time 
basis for the term of the lease, the lease specifies exactly the 
schedule of such intervals, their precise length, and the exact rent for 
such interval.
    (4) The term of the lease is for not less than one year.
    (5) The aggregate rental charge is set in advance, is consistent 
with fair market value in arms-length transactions and is not determined 
in a manner that takes into account the volume or value of any referrals 
or business otherwise generated between the parties for which payment 
may be made in whole or in part under Medicare, Medicaid or all other 
Federal health care programs.
    (6) The aggregate equipment rental does not exceed that which is 
reasonably necessary to accomplish the commercially reasonable business 
purpose of the rental. Note that for purposes of paragraph (c) of this 
section, the term fair market value means that the value of the 
equipment when obtained from a manufacturer or professional distributor, 
but shall not be adjusted to reflect the additional value one party 
(either the prospective lessee or lessor)

[[Page 1030]]

would attribute to the equipment as a result of its proximity or 
convenience to sources of referrals or business otherwise generated for 
which payment may be made in whole or in part under Medicare, Medicaid 
or other Federal health care programs.
    (d) Personal services and management contracts and outcomes-based 
payment arrangements. (1) As used in section 1128B of the Act, 
``remuneration'' does not include any payment made by a principal to an 
agent as compensation for the services of the agent, as long as all of 
the following standards are met:
    (i) The agency agreement is set out in writing and signed by the 
parties.
    (ii) The agency agreement covers all of the services the agent 
provides to the principal for the term of the agreement and specifies 
the services to be provided by the agent.
    (iii) The term of the agreement is not less than 1 year.
    (iv) The methodology for determining the compensation paid to the 
agent over the term of the agreement is set in advance, is consistent 
with fair market value in arm's-length transactions, and is not 
determined in a manner that takes into account the volume or value of 
any referrals or business otherwise generated between the parties for 
which payment may be made in whole or in part under Medicare, Medicaid, 
or other Federal health care programs.
    (v) The services performed under the agreement do not involve the 
counseling or promotion of a business arrangement or other activity that 
violates any State or Federal law.
    (vi) The aggregate services contracted for do not exceed those which 
are reasonably necessary to accomplish the commercially reasonable 
business purpose of the services.
    (2) As used in section 1128B of the Act, ``remuneration'' does not 
include any outcomes-based payment as long as all of the standards in 
paragraphs (d)(2)(i) through (viii) of this section are met:
    (i) To receive an outcomes-based payment, the agent achieves one or 
more legitimate outcome measures that:
    (A) Are selected based on clinical evidence or credible medical 
support; and
    (B) Have benchmarks that are used to quantify:
    (1) Improvements in, or the maintenance of improvements in, the 
quality of patient care;
    (2) A material reduction in costs to or growth in expenditures of 
payors while maintaining or improving quality of care for patients; or
    (3) Both.
    (ii) The methodology for determining the aggregate compensation 
(including any outcomes-based payments) paid between or among the 
parties over the term of the agreement is: Set in advance; commercially 
reasonable; consistent with fair market value; and not determined in a 
manner that directly takes into account the volume or value of any 
referrals or business otherwise generated between the parties for which 
payment may be made in whole or in part by a Federal health care 
program.
    (iii) The agreement between the parties is set out in writing and 
signed by the parties in advance of, or contemporaneous with, the 
commencement of the terms of the outcomes-based payment arrangement. The 
writing states at a minimum: A general description of the services to be 
performed by the parties for the term of the agreement; the outcome 
measure(s) the agent must achieve to receive an outcomes-based payment; 
the clinical evidence or credible medical support relied upon by the 
parties to select the outcome measure(s); and the schedule for the 
parties to regularly monitor and assess the outcome measure(s).
    (iv) The agreement neither limits any party's ability to make 
decisions in their patients' best interest nor induces any party to 
reduce or limit medically necessary items or services.
    (v) The term of the agreement is not less than 1 year.
    (vi) The services performed under the agreement do not involve the 
counseling or promotion of a business arrangement or other activity that 
violates any State or Federal law.
    (vii) For each outcome measure under the agreement, the parties:
    (A) Regularly monitor and assess the agent's performance, including 
the impact of the outcomes-based payment

[[Page 1031]]

arrangement on patient quality of care; and
    (B) Periodically assess, and as necessary revise, benchmarks and 
remuneration under the arrangement to ensure that the remuneration is 
consistent with fair market value in an arm's length transaction as 
required by paragraph (d)(2)(ii) of this section during the term of the 
agreement.
    (viii) The principal has policies and procedures to promptly address 
and correct identified material performance failures or material 
deficiencies in quality of care resulting from the outcomes-based 
payment arrangement.
    (3) For purposes of this paragraph (d):
    (i) An agent of a principal is any person other than a bona fide 
employee of the principal who has an agreement to perform services for 
or on behalf of the principal.
    (ii) Outcomes-based payments are limited to payments between or 
among a principal and an agent that:
    (A) Reward the agent for successfully achieving an outcome measure 
described in paragraph (d)(2)(i) of this section; or
    (B) Recoup from or reduce payment to an agent for failure to achieve 
an outcome measure described in paragraph (d)(2)(i) of this section.
    (iii) Outcomes-based payments exclude any payments:
    (A) Made directly or indirectly by the following entities:
    (1) A pharmaceutical manufacturer, distributor, or wholesaler;
    (2) A pharmacy benefit manager;
    (3) A laboratory company;
    (4) A pharmacy that primarily compounds drugs or primarily dispenses 
compounded drugs;
    (5) A manufacturer of a device or medical supply as defined in 
paragraph (ee)(14)(iv) of this section;
    (6) A medical device distributor or wholesaler that is not otherwise 
a manufacturer of a device or medical supply, as defined in paragraph 
(ee)(14)(iv) of this section; or
    (7) An entity or individual that sells or rents durable medical 
equipment, prosthetics, orthotics, or supplies covered by a Federal 
health care program (other than a pharmacy or a physician, provider, or 
other entity that primarily furnishes services); or
    (B) Related solely to the achievement of internal cost savings for 
the principal; or
    (C) Based solely on patient satisfaction or patient convenience 
measures.
    (e) Sale of practice. (1) As used in section 1128B of the Act, 
``remuneration'' does not include any payment made to a practitioner by 
another practitioner where the former practitioner is selling his or her 
practice to the latter practitioner, as long as both of the following 
two standards are met--
    (i) The period from the date of the first agreement pertaining to 
the sale to the completion of the sale is not more than one year.
    (ii) The practitioner who is selling his or her practice will not be 
in a professional position to make referrals to, or otherwise generate 
business for, the purchasing practitioner for which payment may be made 
in whole or in part under Medicare, Medicaid or other Federal health 
care programs after 1 year from the date of the first agreement 
pertaining to the sale.
    (2) As used in section 1128B of the Act, ``remuneration'' does not 
include any payment made to a practitioner by a hospital or other entity 
where the practitioner is selling his or her practice to the hospital or 
other entity, so long as the following four standards are met:
    (i) The period from the date of the first agreement pertaining to 
the sale to the completion date of the sale is not more than three 
years.
    (ii) The practitioner who is selling his or her practice will not be 
in a professional position after completion of the sale to make or 
influence referrals to, or otherwise generate business for, the 
purchasing hospital or entity for which payment may be made under 
Medicare, Medicaid or other Federal health care programs.
    (iii) The practice being acquired must be located in a Health 
Professional Shortage Area (HPSA), as defined in Departmental 
regulations, for the practitioner's specialty area.
    (iv) Commencing at the time of the first agreement pertaining to the 
sale, the purchasing hospital or entity must diligently and in good 
faith engage in commercially reasonable recruitment activities that:

[[Page 1032]]

    (A) May reasonably be expected to result in the recruitment of a new 
practitioner to take over the acquired practice within a one year period 
and
    (B) Will satisfy the conditions of the practitioner recruitment safe 
harbor in accordance with paragraph (n) of this section.
    (f) Referral services. As used in section 1128B of the Act, 
``remuneration'' does not include any payment or exchange of anything of 
value between an individual or entity (``participant'') and another 
entity serving as a referral service (``referral service''), as long as 
all of the following four standards are met--
    (1) The referral service does not exclude as a participant in the 
referral service any individual or entity who meets the qualifications 
for participation.
    (2) Any payment the participant makes to the referral service is 
assessed equally against and collected equally from all participants and 
is based only on the cost of operating the referral service, and not on 
the volume or value of any referrals to or business otherwise generated 
by either party for the other party for which payment may be made in 
whole or in part under Medicare, Medicaid, or other Federal health care 
programs.
    (3) The referral service imposes no requirements on the manner in 
which the participant provides services to a referred person, except 
that the referral service may require that the participant charge the 
person referred at the same rate as it charges other persons not 
referred by the referral service, or that these services be furnished 
free of charge or at reduced charge.
    (4) The referral service makes the following five disclosures to 
each person seeking a referral, with each such disclosure maintained by 
the referral service in a written record certifying such disclosure and 
signed by either such person seeking a referral or by the individual 
making the disclosure on behalf of the referral service--
    (i) The manner in which it selects the group of participants in the 
referral service to which it could make a referral;
    (ii) Whether the participant has paid a fee to the referral service;
    (iii) The manner in which it selects a particular participant from 
this group for that person;
    (iv) The nature of the relationship between the referral service and 
the group of participants to whom it could make the referral; and
    (v) The nature of any restrictions that would exclude such an 
individual or entity from continuing as a participant.
    (g) Warranties. As used in section 1128B of the Act, 
``remuneration'' does not include any payment or exchange of anything of 
value under a warranty provided by a manufacturer or supplier of one or 
more items and services (provided the warranty covers at least one item) 
to the buyer (such as a health care provider or beneficiary) of the 
items and services, as long as the buyer complies with all of the 
following standards in paragraphs (g)(1) and (2) of this section and the 
manufacturer or supplier complies with all of the following standards in 
paragraphs (g)(3) through (6) of this section:
    (1) The buyer (unless the buyer is a Federal health care program 
beneficiary) must fully and accurately report any price reduction of an 
item or service (including a free item or service) that was obtained as 
part of the warranty in the applicable cost reporting mechanism or claim 
for payment filed with the Department or a State agency.
    (2) The buyer must provide, upon request by the Secretary or a State 
agency, information provided by the manufacturer or supplier as 
specified in paragraph (g)(3) of this section.
    (3) The manufacturer or supplier must comply with either of the 
following standards:
    (i) The manufacturer or supplier must fully and accurately report 
any price reduction of an item or service (including free items and 
services) that the buyer obtained as part of the warranty on the invoice 
or statement submitted to the buyer and inform the buyer of its 
obligations under paragraphs (g)(1) and (2) of this section.
    (ii) When the amount of any price reduction is not known at the time 
of sale, the manufacturer or supplier must fully and accurately report 
the existence of a warranty on the invoice

[[Page 1033]]

or statement, inform the buyer of its obligations under paragraphs 
(g)(1) and (g)(2) of this section, and when any price reduction becomes 
known, provide the buyer with documentation of the calculation of the 
price reduction resulting from the warranty.
    (4) The manufacturer or supplier must not pay any remuneration to 
any individual (other than a beneficiary) or entity for any medical, 
surgical, or hospital expense incurred by a beneficiary other than for 
the cost of the items and services subject to the warranty.
    (5) If a manufacturer or supplier offers a warranty for more than 
one item or one or more items and related services, the federally 
reimbursable items and services subject to the warranty must be 
reimbursed by the same Federal health care program and in the same 
Federal health care program payment.
    (6) The manufacturer or supplier must not condition a warranty on a 
buyer's exclusive use of, or a minimum purchase of, any of the 
manufacturer's or supplier's items or services.
    (7) For purposes of this paragraph (g), the term warranty means:
    (i) Any written affirmation of fact or written promise made in 
connection with the sale of an item or bundle of items, or services in 
combination with one or more related items, by a manufacturer or 
supplier to a buyer, which affirmation of fact or written promise 
relates to the nature of the quality of workmanship and affirms or 
promises that such quality or workmanship is defect free or will meet a 
specified level of performance over a specified period of time;
    (ii) Any undertaking in writing in connection with the sale by a 
manufacturer or supplier of an item or bundle of items, or services in 
combination with one or more related items, to refund, repair, replace, 
or take other remedial action with respect to such item or bundle of 
items in the event that such item or bundle of items, or services in 
combination with one or more related items, fails to meet the 
specifications set forth in the undertaking which written affirmation, 
promise, or undertaking becomes part of the basis of the bargain between 
a seller and a buyer for purposes other than resell of such item or 
bundle of items; or
    (iii) A manufacturer's or supplier's agreement to replace another 
manufacturer's or supplier's defective item or bundle of items (which is 
covered by an agreement made in accordance with this paragraph (g)), on 
terms equal to the agreement that it replaces.
    (h) Discounts. As used in section 1128B of the Act, ``remuneration'' 
does not include a discount, as defined in paragraph (h)(5) of this 
section, on an item or service for which payment may be made in whole or 
in part under Medicare, Medicaid or other Federal health care programs 
for a buyer as long as the buyer complies with the applicable standards 
of paragraph (h)(1) of this section; a seller as long as the seller 
complies with the applicable standards of paragraph (h)(2) of this 
section; and an offeror of a discount who is not a seller under 
paragraph (h)(2) of this section so long as such offeror complies with 
the applicable standards of paragraph (h)(3) of this section.
    (1) With respect to the following three categories of buyers, the 
buyer must comply with all of the applicable standards within one of the 
three following categories--
    (i) If the buyer is an entity which is a health maintenance 
organization (HMO) or a competitive medical plan (CMP) acting in 
accordance with a risk contract under section 1876(g) or 1903(m) of the 
Act, or under another State health care program, it need not report the 
discount except as otherwise may be required under the risk contract.
    (ii) If the buyer is an entity which reports its costs on a cost 
report required by the Department or a State health care program, it 
must comply with all of the following four standards--
    (A) The discount must be earned based on purchases of that same good 
or service bought within a single fiscal year of the buyer;
    (B) The buyer must claim the benefit of the discount in the fiscal 
year in which the discount is earned or the following year;
    (C) The buyer must fully and accurately report the discount in the 
applicable cost report; and

[[Page 1034]]

    (D) the buyer must provide, upon request by the Secretary or a State 
agency, information provided by the seller as specified in paragraph 
(h)(2)(ii) of this section, or information provided by the offeror as 
specified in paragraph (h)(3)(ii) of this section.
    (iii) If the buyer is an individual or entity in whose name a claim 
or request for payment is submitted for the discounted item or service 
and payment may be made, in whole or in part, under Medicare, Medicaid 
or other Federal health care programs (not including individuals or 
entities defined as buyers in paragraph (h)(1)(i) or (h)(1)(ii) of this 
section), the buyer must comply with both of the following standards--
    (A) The discount must be made at the time of the sale of the good or 
service or the terms of the rebate must be fixed and disclosed in 
writing to the buyer at the time of the initial sale of the good or 
service; and
    (B) the buyer (if submitting the claim) must provide, upon request 
by the Secretary or a State agency, information provided by the seller 
as specified in paragraph (h)(2)(iii)(B) of this section, or information 
provided by the offeror as specified in paragraph (h)(3)(iii)(A) of this 
section.
    (2) The seller is an individual or entity that supplies an item or 
service for which payment may be made, in whole or in part, under 
Medicare, Medicaid or other Federal health care programs to the buyer 
and who permits a discount to be taken off the buyer's purchase price. 
The seller must comply with all of the applicable standards within one 
of the following three categories--
    (i) If the buyer is an entity which is an HMO a CMP acting in 
accordance with a risk contract under section 1876(g) or 1903(m) of the 
Act, or under another State health care program, the seller need not 
report the discount to the buyer for purposes of this provision.
    (ii) If the buyer is an entity that reports its costs on a cost 
report required by the Department or a State agency, the seller must 
comply with either of the following two standards--
    (A) Where a discount is required to be reported to Medicare or a 
State health care program under paragraph (h)(1) of this section, the 
seller must fully and accurately report such discount on the invoice, 
coupon or statement submitted to the buyer; inform the buyer in a manner 
that is reasonably calculated to give notice to the buyer of its 
obligations to report such discount and to provide information upon 
request under paragraph (h)(1) of this section; and refrain from doing 
anything that would impede the buyer from meeting its obligations under 
this paragraph; or
    (B) Where the value of the discount is not known at the time of 
sale, the seller must fully and accurately report the existence of a 
discount program on the invoice, coupon or statement submitted to the 
buyer; inform the buyer in a manner reasonably calculated to give notice 
to the buyer of its obligations to report such discount and to provide 
information upon request under paragraph (h)(1) of this section; when 
the value of the discount becomes known, provide the buyer with 
documentation of the calculation of the discount identifying the 
specific goods or services purchased to which the discount will be 
applied; and refrain from doing anything which would impede the buyer 
from meeting its obligations under this paragraph.
    (iii) If the buyer is an individual or entity not included in 
paragraph (h)(2)(i) or (h)(2)(ii) of this section, the seller must 
comply with either of the following two standards--
    (A) Where the seller submits a claim or request for payment on 
behalf of the buyer and the item or service is separately claimed, the 
seller must provide, upon request by the Secretary or a State agency, 
information provided by the offeror as specified in paragraph 
(h)(3)(iii)(A) of this section; or
    (B) Where the buyer submits a claim, the seller must fully and 
accurately report such discount on the invoice, coupon or statement 
submitted to the buyer; inform the buyer in a manner reasonably 
calculated to give notice to the buyer of its obligations to report such 
discount and to provide information upon request under paragraph (h)(1) 
of this section; and refrain from doing anything that would impede the 
buyer from meeting its obligations under this paragraph.

[[Page 1035]]

    (3) The offeror of a discount is an individual or entity who is not 
a seller under paragraph (h)(2) of this section, but promotes the 
purchase of an item or service by a buyer under paragraph (h)(1) of this 
section at a reduced price for which payment may be made, in whole or in 
part, under Medicare, Medicaid or other Federal health care programs. 
The offeror must comply with all of the applicable standards within the 
following three categories--
    (i) If the buyer is an entity which is an HMO or a CMP acting in 
accordance with a risk contract under section 1876(g) or 1903(m) of the 
Act, or under another State health care program, the offeror need not 
report the discount to the buyer for purposes of this provision.
    (ii) If the buyer is an entity that reports its costs on a cost 
report required by the Department or a State agency, the offeror must 
comply with the following two standards--
    (A) The offeror must inform the buyer in a manner reasonably 
calculated to give notice to the buyer of its obligations to report such 
a discount and to provide information upon request under paragraph 
(h)(1) of this section; and
    (B) The offeror of the discount must refrain from doing anything 
that would impede the buyer's ability to meet its obligations under this 
paragraph.
    (iii) If the buyer is an individual or entity in whose name a 
request for payment is submitted for the discounted item or service and 
payment may be made, in whole or in part, under Medicare, Medicaid or 
other Federal health care programs (not including individuals or 
entities defined as buyers in paragraph (h)(1)(i) or (h)(1)(ii) of this 
section), the offeror must comply with the following two standards--
    (A) The offeror must inform the individual or entity submitting the 
claim or request for payment in a manner reasonably calculated to give 
notice to the individual or entity of its obligations to report such a 
discount and to provide information upon request under paragraphs (h)(1) 
and (h)(2) of this section; and
    (B) The offeror of the discount must refrain from doing anything 
that would impede the buyer's or seller's ability to meet its 
obligations under this paragraph.
    (4) For purposes of this paragraph, a rebate is any discount the 
terms of which are fixed and disclosed in writing to the buyer at the 
time of the initial purchase to which the discount applies, but which is 
not given at the time of sale.
    (5) For purposes of this paragraph, the term discount means a 
reduction in the amount a buyer (who buys either directly or through a 
wholesaler or a group purchasing organization) is charged for an item or 
service based on an arms-length transaction. The term discount does not 
include--
    (i) Cash payment or cash equivalents (except that rebates as defined 
in paragraph (h)(4) of this section may be in the form of a check);
    (ii) Supplying one good or service without charge or at a reduced 
charge to induce the purchase of a different good or service, unless the 
goods and services are reimbursed by the same Federal health care 
program using the same methodology and the reduced charge is fully 
disclosed to the Federal health care program and accurately reflected 
where appropriate, and as appropriate, to the reimbursement methodology;
    (iii) A reduction in price applicable to one payer but not to 
Medicare, Medicaid or other Federal health care programs;
    (iv) A routine reduction or waiver of any coinsurance or deductible 
amount owed by a program beneficiary;
    (v) Warranties;
    (vi) Services provided in accordance with a personal or management 
services contract; or
    (vii) Other remuneration, in cash or in kind, not explicitly 
described in paragraph (h)(5) of this section.
    (i) Employees. As used in section 1128B of the Act, ``remuneration'' 
does not include any amount paid by an employer to an employee, who has 
a bona fide employment relationship with the employer, for employment in 
the furnishing of any item or service for which payment may be made in 
whole or in part under Medicare, Medicaid or other Federal health care 
programs. For purposes of paragraph (i) of this section, the term 
employee has the

[[Page 1036]]

same meaning as it does for purposes of 26 U.S.C. 3121(d)(2).
    (j) Group purchasing organizations. As used in section 1128B of the 
Act, ``remuneration'' does not include any payment by a vendor of goods 
or services to a group purchasing organization (GPO), as part of an 
agreement to furnish such goods or services to an individual or entity 
as long as both of the following two standards are met--
    (1) The GPO must have a written agreement with each individual or 
entity, for which items or services are furnished, that provides for 
either of the following--
    (i) The agreement states that participating vendors from which the 
individual or entity will purchase goods or services will pay a fee to 
the GPO of 3 percent or less of the purchase price of the goods or 
services provided by that vendor.
    (ii) In the event the fee paid to the GPO is not fixed at 3 percent 
or less of the purchase price of the goods or services, the agreement 
specifies the amount (or if not known, the maximum amount) the GPO will 
be paid by each vendor (where such amount may be a fixed sum or a fixed 
percentage of the value of purchases made from the vendor by the members 
of the group under the contract between the vendor and the GPO).
    (2) Where the entity which receives the goods or service from the 
vendor is a health care provider of services, the GPO must disclose in 
writing to the entity at least annually, and to the Secretary upon 
request, the amount received from each vendor with respect to purchases 
made by or on behalf of the entity. Note that for purposes of paragraph 
(j) of this section, the term group purchasing organization (GPO) means 
an entity authorized to act as a purchasing agent for a group of 
individuals or entities who are furnishing services for which payment 
may be made in whole or in part under Medicare, Medicaid or other 
Federal health care programs, and who are neither wholly-owned by the 
GPO nor subsidiaries of a parent corporation that wholly owns the GPO 
(either directly or through another wholly-owned entity).
    (k) Waiver of beneficiary copayment, coinsurance and deductible 
amounts. As used in section 1128B of the Act, ``remuneration'' does not 
include any reduction or waiver of a Federal health care program 
beneficiary's obligation to pay copayment, coinsurance or deductible 
(for purposes of this subparagraph (k) ``cost-sharing'') amounts as long 
as all the standards are met within one of the following categories of 
health care providers or suppliers.
    (1) If the cost-sharing amounts are owed to a hospital for inpatient 
hospital services for which a Federal health care program pays under the 
prospective payment system, the hospital must comply with all of the 
following three standards:
    (i) The hospital must not later claim the amount reduced or waived 
as a bad debt for payment purposes under a Federal health care program 
or otherwise shift the burden of the reduction or waiver onto a Federal 
health care program, other payers, or individuals.
    (ii) The hospital must offer to reduce or waive the cost-sharing 
amounts without regard to the reason for admission, the length of stay 
of the beneficiary, or the diagnostic related group for which the claim 
for reimbursement is filed.
    (iii) The hospital's offer to reduce or waive the cost-sharing 
amounts must not be made as part of a price reduction agreement between 
a hospital and a third-party payer (including a health plan as defined 
in paragraph (l)(2) of this section), unless the agreement is part of a 
contract for the furnishing of items or services to a beneficiary of a 
Medicare supplemental policy issued under the terms of section 
1882(t)(1) of the Act.
    (2) If the cost-sharing amounts are owed by an individual who 
qualifies for subsidized services under a provision of the Public Health 
Services Act or under Titles V or XIX of the Act to a federally 
qualified health care center or other health care facility under any 
Public Health Services Act grant program or under Title V of the Act, 
the health care center or facility may reduce or waive the cost-sharing 
amounts for items or services for which payment may be made in whole or 
in part by a Federal health care program.

[[Page 1037]]

    (3) If the cost-sharing amounts are owed to a pharmacy (including, 
but not limited to, pharmacies of the Indian Health Service, Indian 
tribes, tribal organizations, and urban Indian organizations) for cost-
sharing imposed under a Federal health care program, the pharmacy may 
reduce or waive the cost-sharing amounts if:
    (i) The waiver or reduction is not offered as part of an 
advertisement or solicitation; and
    (ii) Except for waivers or reductions offered to subsidy-eligible 
individuals (as defined in section 1860D-14(a)(3)) to which only 
requirement in paragraph (k)(3)(i) of this section applies:
    (A) The pharmacy does not routinely waive or reduce cost-sharing 
amounts; and
    (B) The pharmacy waives the cost-sharing amounts only after 
determining in good faith that the individual is in financial need or 
after failing to collect the cost-sharing amounts after making 
reasonable collection efforts.
    (4) If the cost-sharing amounts are owed to an ambulance provider or 
supplier for emergency ambulance services for which a Federal health 
care program pays under a fee-for-service payment system and all the 
following conditions are met:
    (i) The ambulance provider or supplier is owned and operated by a 
State, a political subdivision of a State, or a tribal health care 
program, as that term is defined in section 4 of the Indian Health Care 
Improvement Act;
    (ii) The ambulance provider or supplier engaged in an emergency 
response, as defined in 42 CFR 414.605;
    (iii) The ambulance provider or supplier offers the reduction or 
waiver on a uniform basis to all of its residents or (if applicable) 
tribal members, or to all individuals transported; and
    (iv) The ambulance provider or supplier must not later claim the 
amount reduced or waived as a bad debt for payment purposes under a 
Federal health care program or otherwise shift the burden of the 
reduction or waiver onto a Federal health care program, other payers, or 
individuals.
    (l) Increased coverage, reduced cost-sharing amounts, or reduced 
premium amounts offered by health plans. (1) As used in section 1128B of 
the Act, ``remuneration'' does not include the additional coverage of 
any item or service offered by a health plan to an enrollee or the 
reduction of some or all of the enrollee's obligation to pay the health 
plan or a contract health care provider for cost-sharing amounts (such 
as coinsurance, deductible, or copayment amounts) or for premium amounts 
attributable to items or services covered by the health plan, the 
Medicare program, or a State health care program, as long as the health 
plan complies with all of the standards within one of the following two 
categories of health plans:
    (i) If the health plan is a risk-based health maintenance 
organization, competitive medical plan, prepaid health plan, or other 
health plan under contract with CMS or a State health care program and 
operating in accordance with section 1876(g) or 1903(m) of the Act, 
under a Federal statutory demonstration authority, or under other 
Federal statutory or regulatory authority, it must offer the same 
increased coverage or reduced cost-sharing or premium amounts to all 
Medicare or State health care program enrollees covered by the contract 
unless otherwise approved by CMS or by a State health care program.
    (ii) If the health plan is a health maintenance organization, 
competitive medical plan, health care prepayment plan, prepaid health 
plan or other health plan that has executed a contract or agreement with 
CMS or with a State health care program to receive payment for enrollees 
on a reasonable cost or similar basis, it must comply with both of the 
following two standards--
    (A) The health plan must offer the same increased coverage or 
reduced cost-sharing or premium amounts to all Medicare or State health 
care program enrollees covered by the contract or agreement unless 
otherwise approved by CMS or by a State health care program; and
    (B) The health plan must not claim the costs of the increased 
coverage or the reduced cost-sharing or premium amounts as a bad debt 
for payment purposes under Medicare or a State health care program or 
otherwise shift

[[Page 1038]]

the burden of the increased coverage or reduced cost-sharing or premium 
amounts to the extent that increased payments are claimed from Medicare 
or a State health care program.
    (2) For purposes of paragraph (l) of this section, the terms--
    Contract health care provider means an individual or entity under 
contract with a health plan to furnish items or services to enrollees 
who are covered by the health plan, Medicare, or a State health care 
program.
    Enrollee means an individual who has entered into a contractual 
relationship with a health plan (or on whose behalf an employer, or 
other private or governmental entity has entered into such a 
relationship) under which the individual is entitled to receive 
specified health care items and services, or insurance coverage for such 
items and services, in return for payment of a premium or a fee.
    Health plan means an entity that furnishes or arranges under 
agreement with contract health care providers for the furnishing of 
items or services to enrollees, or furnishes insurance coverage for the 
provision of such items and services, in exchange for a premium or a 
fee, where such entity:
    (i) Operates in accordance with a contract, agreement or statutory 
demonstration authority approved by CMS or a State health care program;
    (ii) Charges a premium and its premium structure is regulated under 
a State insurance statute or a State enabling statute governing health 
maintenance organizations or preferred provider organizations;
    (iii) Is an employer, if the enrollees of the plan are current or 
retired employees, or is a union welfare fund, if the enrollees of the 
plan are union members; or
    (iv) Is licensed in the State, is under contract with an employer, 
union welfare fund, or a company furnishing health insurance coverage as 
described in conditions (ii) and (iii) of this definition, and is paid a 
fee for the administration of the plan which reflects the fair market 
value of those services.
    (m) Price reductions offered to health plans. (1) As used in section 
1128B of the Act, ``remuneration'' does not include a reduction in price 
a contract health care provider offers to a health plan in accordance 
with the terms of a written agreement between the contract health care 
provider and the health plan for the sole purpose of furnishing to 
enrollees items or services that are covered by the health plan, 
Medicare, or a State health care program, as long as both the health 
plan and contract health care provider comply with all of the applicable 
standards within one of the following four categories of health plans:
    (i) If the health plan is a risk-based health maintenance 
organization, competitive medical plan, or prepaid health plan under 
contract with CMS or a State agency and operating in accordance with 
section 1876(g) or 1903(m) of the Act, under a Federal statutory 
demonstration authority, or under other Federal statutory or regulatory 
authority, the contract health care provider must not claim payment in 
any form from the Department or the State agency for items or services 
furnished in accordance with the agreement except as approved by CMS or 
the State health care program, or otherwise shift the burden of such an 
agreement to the extent that increased payments are claimed from 
Medicare or a State health care program.
    (ii) If the health plan is a health maintenance organization, 
competitive medical plan, health care prepayment plan, prepaid health 
plan, or other health plan that has executed a contract or agreement 
with CMS or a State health care program to receive payment for enrollees 
on a reasonable cost or similar basis, the health plan and contract 
health care provider must comply with all of the following four 
standards--
    (A) The term of the agreement between the health plan and the 
contract health care provider must be for not less than one year;
    (B) The agreement between the health plan and the contract health 
care provider must specify in advance the covered items and services to 
be furnished to enrollees, and the methodology for computing the payment 
to the contract health care provider;
    (C) The health plan must fully and accurately report, on the 
applicable cost report or other claim form filed

[[Page 1039]]

with the Department or the State health care program, the amount it has 
paid the contract health care provider under the agreement for the 
covered items and services furnished to enrollees; and
    (D) The contract health care provider must not claim payment in any 
form from the Department or the State health care program for items or 
services furnished in accordance with the agreement except as approved 
by CMS or the State health care program, or otherwise shift the burden 
of such an agreement to the extent that increased payments are claimed 
from Medicare or a State health care program.
    (iii) If the health plan is not described in paragraphs (m)(1)(i) or 
(m)(1)(ii) of this section and the contract health care provider is not 
paid on an at-risk, capitated basis, both the health plan and contract 
health care provider must comply with all of the following six 
standards--
    (A) The term of the agreement between the health plan and the 
contract health care provider must be for not less than one year;
    (B) The agreement between the health plan and the contract health 
care provider must specify in advance the covered items and services to 
be furnished to enrollees, which party is to file claims or requests for 
payment with Medicare or the State health care program for such items 
and services, and the schedule of fees the contract health care provider 
will charge for furnishing such items and services to enrollees;
    (C) The fee schedule contained in the agreement between the health 
plan and the contract health care provider must remain in effect 
throughout the term of the agreement, unless a fee increase results 
directly from a payment update authorized by Medicare or the State 
health care program;
    (D) The party submitting claims or requests for payment from 
Medicare or the State health care program for items and services 
furnished in accordance with the agreement must not claim or request 
payment for amounts in excess of the fee schedule;
    (E) The contract health care provider and the health plan must fully 
and accurately report on any cost report filed with Medicare or a State 
health care program the fee schedule amounts charged in accordance with 
the agreement and, upon request, will report to the Medicare or a State 
health care program the terms of the agreement and the amounts paid in 
accordance with the agreement; and
    (F) The party to the agreement, which does not have the 
responsibility under the agreement for filing claims or requests for 
payment, must not claim or request payment in any form from the 
Department or the State health care program for items or services 
furnished in accordance with the agreement, or otherwise shift the 
burden of such an agreement to the extent that increased payments are 
claimed from Medicare or a State health care program.
    (iv) If the health plan is not described in paragraphs (m)(1)(i) or 
(m)(1)(ii) of this section, and the contract health care provider is 
paid on an at-risk, capitated basis, both the health plan and contract 
health care provider must comply with all of the following five 
standards--
    (A) The term of the agreement between the health plan and the 
contract health provider must be for not less than one year;
    (B) The agreement between the health plan and the contract health 
provider must specify in advance the covered items and services to be 
furnished to enrollees and the total amount per enrollee (which may be 
expressed in a per month or other time period basis) the contract health 
care provider will be paid by the health plan for furnishing such items 
and services to enrollees and must set forth any copayments, if any, to 
be paid by enrollees to the contract health care provider for covered 
services;
    (C) The payment amount contained in the agreement between the health 
care plan and the contract health care provider must remain in effect 
throughout the term of the agreement;
    (D) The contract health care provider and the health plan must fully 
and accurately report to the Medicare and State health care program upon 
request, the terms of the agreement and the amounts paid in accordance 
with the agreement; and

[[Page 1040]]

    (E) The contract health care provider must not claim or request 
payment in any form from the Department, a State health care program or 
an enrollee (other than copayment amounts described in paragraph 
(m)(2)(iv)(B) of this section) and the health plan must not pay the 
contract care provider in excess of the amounts described in paragraph 
(m)(2)(iv)(B) of this section for items and services covered by the 
agreement.
    (2) For purposes of this paragraph, the terms contract health care 
provider, enrollee, and health plan have the same meaning as in 
paragraph (l)(2) of this section.
    (n) Practitioner recruitment. As used in section 1128B of the Act, 
``remuneration'' does not include any payment or exchange of anything of 
value by an entity in order to induce a practitioner who has been 
practicing within his or her current specialty for less than one year to 
locate, or to induce any other practitioner to relocate, his or her 
primary place of practice into a HPSA for his or her specialty area, as 
defined in Departmental regulations, that is served by the entity, as 
long as all of the following nine standards are met--
    (1) The arrangement is set forth in a written agreement signed by 
the parties that specifies the benefits provided by the entity, the 
terms under which the benefits are to be provided, and the obligations 
of each party.
    (2) If a practitioner is leaving an established practice, at least 
75 percent of the revenues of the new practice must be generated from 
new patients not previously seen by the practitioner at his or her 
former practice.
    (3) The benefits are provided by the entity for a period not in 
excess of 3 years, and the terms of the agreement are not renegotiated 
during this 3-year period in any substantial aspect; provided, however, 
that if the HPSA to which the practitioner was recruited ceases to be a 
HPSA during the term of the written agreement, the payments made under 
the written agreement will continue to satisfy this paragraph for the 
duration of the written agreement (not to exceed 3 years).
    (4) There is no requirement that the practitioner make referrals to, 
be in a position to make or influence referrals to, or otherwise 
generate business for the entity as a condition for receiving the 
benefits; provided, however, that for purposes of this paragraph, the 
entity may require as a condition for receiving benefits that the 
practitioner maintain staff privileges at the entity.
    (5) The practitioner is not restricted from establishing staff 
privileges at, referring any service to, or otherwise generating any 
business for any other entity of his or her choosing.
    (6) The amount or value of the benefits provided by the entity may 
not vary (or be adjusted or renegotiated) in any manner based on the 
volume or value of any expected referrals to or business otherwise 
generated for the entity by the practitioner for which payment may be 
made in whole or in part under Medicare, Medicaid or any other Federal 
health care programs.
    (7) The practitioner agrees to treat patients receiving medical 
benefits or assistance under any Federal health care program in a 
nondiscriminatory manner.
    (8) At least 75 percent of the revenues of the new practice must be 
generated from patients residing in a HPSA or a Medically Underserved 
Area (MUA) or who are part of a Medically Underserved Population (MUP), 
all as defined in paragraph (a) of this section.
    (9) The payment or exchange of anything of value may not directly or 
indirectly benefit any person (other than the practitioner being 
recruited) or entity in a position to make or influence referrals to the 
entity providing the recruitment payments or benefits of items or 
services payable by a Federal health care program.
    (o) Obstetrical malpractice insurance subsidies. As used in section 
1128B of the Act, ``remuneration'' does not include any payment made by 
a hospital or other entity to another entity that is providing 
malpractice insurance (including a self-funded entity), where such 
payment is used to pay for some or all of the costs of malpractice 
insurance premiums for a practitioner (including a certified nurse-
midwife as defined in section 1861(gg) of the Act) who engages in 
obstetrical practice as a routine part of his or her medical practice in 
a primary care HPSA, as long as

[[Page 1041]]

all of the following seven standards are met--
    (1) The payment is made in accordance with a written agreement 
between the entity paying the premiums and the practitioner, which sets 
out the payments to be made by the entity, and the terms under which the 
payments are to be provided.
    (2)(i) The practitioner must certify that for the initial coverage 
period (not to exceed one year) the practitioner has a reasonable basis 
for believing that at least 75 percent of the practitioner's obstetrical 
patients treated under the coverage of the malpractice insurance will 
either--
    (A) Reside in a HPSA or MUA, as defined in paragraph (a) of this 
section; or
    (B) Be part of a MUP, as defined in paragraph (a) of this section.
    (ii) Thereafter, for each additional coverage period (not to exceed 
one year), at least 75 percent of the practitioner's obstetrical 
patients treated under the prior coverage period (not to exceed one 
year) must have--
    (A) Resided in a HPSA or MUA, as defined in paragraph (a) of this 
section; or
    (B) Been part of a MUP, as defined in paragraph (a) of this section.
    (3) There is no requirement that the practitioner make referrals to, 
or otherwise generate business for, the entity as a condition for 
receiving the benefits.
    (4) The practitioner is not restricted from establishing staff 
privileges at, referring any service to, or otherwise generating any 
business for any other entity of his or her choosing.
    (5) The amount of payment may not vary based on the volume or value 
of any previous or expected referrals to or business otherwise generated 
for the entity by the practitioner for which payment may be made in 
whole or in part under Medicare, Medicaid or any other Federal health 
care programs.
    (6) The practitioner must treat obstetrical patients who receive 
medical benefits or assistance under any Federal health care program in 
a nondiscriminatory manner.
    (7) The insurance is a bona fide malpractice insurance policy or 
program, and the premium, if any, is calculated based on a bona fide 
assessment of the liability risk covered under the insurance. For 
purposes of paragraph (o) of this section, costs of malpractice 
insurance premiums means:
    (i) For practitioners who engage in obstetrical practice full-time, 
any costs attributable to malpractice insurance; or
    (ii) For practitioners who engage in obstetrical practice on a part-
time or sporadic basis, the costs:
    (A) Attributable exclusively to the obstetrical portion of the 
practitioner's malpractice insurance and
    (B) Related exclusively to obstetrical services provided in a 
primary care HPSA.
    (p) Investments in group practices. As used in section 1128B of the 
Act, ``remuneration'' does not include any payment that is a return on 
an investment interest, such as a dividend or interest income, made to a 
solo or group practitioner investing in his or her own practice or group 
practice if the following four standards are met--
    (1) The equity interests in the practice or group must be held by 
licensed health care professionals who practice in the practice or 
group.
    (2) The equity interests must be in the practice or group itself, 
and not some subdivision of the practice or group.
    (3) In the case of group practices, the practice must:
    (i) Meet the definition of ``group practice'' in section 1877(h)(4) 
of the Social Security Act and implementing regulations; and
    (ii) Be a unified business with centralized decision-making, pooling 
of expenses and revenues, and a compensation/profit distribution system 
that is not based on satellite offices operating substantially as if 
they were separate enterprises or profit centers.
    (4) Revenues from ancillary services, if any, must be derived from 
``in-office ancillary services'' that meet the definition of such term 
in section 1877(b)(2) of the Act and implementing regulations.
    (q) Cooperative hospital service organizations. As used in section 
1128B of the Act, ``remuneration'' does not include any payment made 
between a cooperative hospital service organization

[[Page 1042]]

(CHSO) and its patron-hospital, both of which are described in section 
501(e) of the Internal Revenue Code of 1986 and are tax-exempt under 
section 501(c)(3) of the Internal Revenue Code, where the CHSO is wholly 
owned by two or more patron-hospitals, as long as the following 
standards are met--
    (1) If the patron-hospital makes a payment to the CHSO, the payment 
must be for the purpose of paying for the bona fide operating expenses 
of the CHSO, or
    (2) If the CHSO makes a payment to the patron-hospital, the payment 
must be for the purpose of paying a distribution of net earnings 
required to be made under section 501(e)(2) of the Internal Revenue Code 
of 1986.
    (r) Ambulatory surgical centers. As used in section 1128B of the 
Act, ``remuneration'' does not include any payment that is a return on 
an investment interest, such as a dividend or interest income, made to 
an investor, as long as the investment entity is a certified ambulatory 
surgical center (ASC) under part 416 of this title, whose operating and 
recovery room space is dedicated exclusively to the ASC, patients 
referred to the investment entity by an investor are fully informed of 
the investor's investment interest, and all of the applicable standards 
are met within one of the following four categories--
    (1) Surgeon-owned ASCs--If all of the investors are general surgeons 
or surgeons engaged in the same surgical specialty, who are in a 
position to refer patients directly to the entity and perform surgery on 
such referred patients; surgical group practices (as defined in this 
paragraph) composed exclusively of such surgeons; or investors who are 
not employed by the entity or by any investor, are not in a position to 
provide items or services to the entity or any of its investors, and are 
not in a position to make or influence referrals directly or indirectly 
to the entity or any of its investors, all of the following six 
standards must be met--
    (i) The terms on which an investment interest is offered to an 
investor must not be related to the previous or expected volume of 
referrals, services furnished, or the amount of business otherwise 
generated from that investor to the entity.
    (ii) At least one-third of each surgeon investor's medical practice 
income from all sources for the previous fiscal year or previous 12-
month period must be derived from the surgeon's performance of 
procedures (as defined in this paragraph).
    (iii) The entity or any investor (or other individual or entity 
acting on behalf of the entity or any investor) must not loan funds to 
or guarantee a loan for an investor if the investor uses any part of 
such loan to obtain the investment interest.
    (iv) The amount of payment to an investor in return for the 
investment must be directly proportional to the amount of the capital 
investment (including the fair market value of any pre-operational 
services rendered) of that investor.
    (v) All ancillary services for Federal health care program 
beneficiaries performed at the entity must be directly and integrally 
related to primary procedures performed at the entity, and none may be 
separately billed to Medicare or other Federal health care programs.
    (vi) The entity and any surgeon investors must treat patients 
receiving medical benefits or assistance under any Federal health care 
program in a nondiscriminatory manner.
    (2) Single-Specialty ASCs--If all of the investors are physicians 
engaged in the same medical practice specialty who are in a position to 
refer patients directly to the entity and perform procedures on such 
referred patients; group practices (as defined in this paragraph) 
composed exclusively of such physicians; or investors who are not 
employed by the entity or by any investor, are not in a position to 
provide items or services to the entity or any of its investors, and are 
not in a position to make or influence referrals directly or indirectly 
to the entity or any of its investors, all of the following six 
standards must be met--
    (i) The terms on which an investment interest is offered to an 
investor must

[[Page 1043]]

not be related to the previous or expected volume of referrals, services 
furnished, or the amount of business otherwise generated from that 
investor to the entity.
    (ii) At least one-third of each physician investor's medical 
practice income from all sources for the previous fiscal year or 
previous 12-month period must be derived from the surgeon's performance 
of procedures (as defined in this paragraph).
    (iii) The entity or any investor (or other individual or entity 
acting on behalf of the entity or any investor) must not loan funds to 
or guarantee a loan for an investor if the investor uses any part of 
such loan to obtain the investment interest.
    (iv) The amount of payment to an investor in return for the 
investment must be directly proportional to the amount of the capital 
investment (including the fair market value of any pre-operational 
services rendered) of that investor.
    (v) All ancillary services for Federal health care program 
beneficiaries performed at the entity must be directly and integrally 
related to primary procedures performed at the entity, and none may be 
separately billed to Medicare or other Federal health care programs.
    (vi) The entity and any physician investors must treat patients 
receiving medical benefits or assistance under any Federal health care 
program in a nondiscriminatory manner.
    (3) Multi-Specialty ASCs--If all of the investors are physicians who 
are in a position to refer patients directly to the entity and perform 
procedures on such referred patients; group practices, as defined in 
this paragraph, composed exclusively of such physicians; or investors 
who are not employed by the entity or by any investor, are not in a 
position to provide items or services to the entity or any of its 
investors, and are not in a position to make or influence referrals 
directly or indirectly to the entity or any of its investors, all of the 
following seven standards must be met--
    (i) The terms on which an investment interest is offered to an 
investor must not be related to the previous or expected volume of 
referrals, services furnished, or the amount of business otherwise 
generated from that investor to the entity.
    (ii) At least one-third of each physician investor's medical 
practice income from all sources for the previous fiscal year or 
previous 12-month period must be derived from the physician's 
performance of procedures (as defined in this paragraph).
    (iii) At least one-third of the procedures (as defined in this 
paragraph) performed by each physician investor for the previous fiscal 
year or previous 12-month period must be performed at the investment 
entity.
    (iv) The entity or any investor (or other individual or entity 
acting on behalf of the entity or any investor) must not loan funds to 
or guarantee a loan for an investor if the investor uses any part of 
such loan to obtain the investment interest.
    (v) The amount of payment to an investor in return for the 
investment must be directly proportional to the amount of the capital 
investment (including the fair market value of any pre-operational 
services rendered) of that investor.
    (vi) All ancillary services for Federal health care program 
beneficiaries performed at the entity must be directly and integrally 
related to primary procedures performed at the entity, and none may be 
separately billed to Medicare or other Federal health care programs.
    (vii) The entity and any physician investors must treat patients 
receiving medical benefits or assistance under any Federal health care 
program in a nondiscriminatory manner.
    (4) Hospital/Physician ASCs--If at least one investor is a hospital, 
and all of the remaining investors are physicians who meet the 
requirements of paragraphs (r)(1), (r)(2) or (r)(3) of this section; 
group practices (as defined in this paragraph) composed of such 
physicians; surgical group practices (as defined in this paragraph); or 
investors who are not employed by the entity or by any investor, are not 
in a position to provide items or services to the entity or any of its 
investors, and are not in a position to refer patients directly or 
indirectly to the entity or any of its

[[Page 1044]]

investors, all of the following eight standards must be met--
    (i) The terms on which an investment interest is offered to an 
investor must not be related to the previous or expected volume of 
referrals, services furnished, or the amount of business otherwise 
generated from that investor to the entity.
    (ii) The entity or any investor (or other individual or entity 
acting on behalf of the entity or any investor) must not loan funds to 
or guarantee a loan for an investor if the investor uses any part of 
such loan to obtain the investment interest.
    (iii) The amount of payment to an investor in return for the 
investment must be directly proportional to the amount of the capital 
investment (including the fair market value of any pre-operational 
services rendered) of that investor.
    (iv) The entity and any hospital or physician investor must treat 
patients receiving medical benefits or assistance under any Federal 
health care program in a nondiscriminatory manner.
    (v) The entity may not use space, including, but not limited to, 
operating and recovery room space, located in or owned by any hospital 
investor, unless such space is leased from the hospital in accordance 
with a lease that complies with all the standards of the space rental 
safe harbor set forth in paragraph (b) of this section; nor may it use 
equipment owned by or services provided by the hospital unless such 
equipment is leased in accordance with a lease that complies with the 
equipment rental safe harbor set forth in paragraph (c) of this section, 
and such services are provided in accordance with a contract that 
complies with the personal services and management contracts safe harbor 
set forth in paragraph (d) of this section.
    (vi) All ancillary services for Federal health care program 
beneficiaries performed at the entity must be directly and integrally 
related to primary procedures performed at the entity, and none may be 
separately billed to Medicare or other Federal health care programs.
    (vii) The hospital may not include on its cost report or any claim 
for payment from a Federal health care program any costs associated with 
the ASC (unless such costs are required to be included by a Federal 
health care program).
    (viii) The hospital may not be in a position to make or influence 
referrals directly or indirectly to any investor or the entity.
    (5) For purposes of paragraph (r) of this section, procedures means 
any procedure or procedures on the list of Medicare-covered procedures 
for ambulatory surgical centers in accordance with regulations issued by 
the Department and group practice means a group practice that meets all 
of the standards of paragraph (p) of this section. Surgical group 
practice means a group practice that meets all of the standards of 
paragraph (p) of this section and is composed exclusively of surgeons 
who meet the requirements of paragraph (r)(1) of this section.
    (s) Referral arrangements for specialty services. As used in section 
1128B of the Act, ``remuneration'' does not include any exchange of 
value among individuals and entities where one party agrees to refer a 
patient to the other party for the provision of a specialty service 
payable in whole or in part under Medicare, Medicaid or any other 
Federal health care programs in return for an agreement on the part of 
the other party to refer that patient back at a mutually agreed upon 
time or circumstance as long as the following four standards are met--
    (1) The mutually agreed upon time or circumstance for referring the 
patient back to the originating individual or entity is clinically 
appropriate.
    (2) The service for which the referral is made is not within the 
medical expertise of the referring individual or entity, but is within 
the special expertise of the other party receiving the referral.
    (3) The parties receive no payment from each other for the referral 
and do not share or split a global fee from any Federal health care 
program in connection with the referred patient.
    (4) Unless both parties belong to the same group practice as defined 
in paragraph (p) of this section, the only exchange of value between the 
parties is the remuneration the parties receive

[[Page 1045]]

directly from third-party payors or the patient compensating the parties 
for the services they each have furnished to the patient.
    (t) Price reductions offered to eligible managed care organizations. 
(1) As used in section 1128(B) of the Act, ``remuneration'' does not 
include any payment between:
    (i) An eligible managed care organization and any first tier 
contractor for providing or arranging for items or services, as long as 
the following three standards are met--
    (A) The eligible managed care organization and the first tier 
contractor have an agreement that:
    (1) Is set out in writing and signed by both parties;
    (2) Specifies the items and services covered by the agreement;
    (3) Is for a period of at least one year; and
    (4) Specifies that the first tier contractor cannot claim payment in 
any form directly or indirectly from a Federal health care program for 
items or services covered under the agreement, except for:
    (i) HMOs and competitive medical plans with cost-based contracts 
under section 1876 of the Act where the agreement with the eligible 
managed care organization sets out the arrangements in accordance with 
which the first tier contractor is billing the Federal health care 
program;
    (ii) Federally qualified HMOs without a contract under sections 1854 
or 1876 of the Act, where the agreement with the eligible managed care 
organization sets out the arrangements in accordance with which the 
first tier contractor is billing the Federal health care program; or
    (iii) First tier contractors that are Federally qualified health 
centers that claim supplemental payments from a Federal health care 
program.
    (B) In establishing the terms of the agreement, neither party gives 
or receives remuneration in return for or to induce the provision or 
acceptance of business (other than business covered by the agreement) 
for which payment may be made in whole or in part by a Federal health 
care program on a fee-for-service or cost basis.
    (C) Neither party to the agreement shifts the financial burden of 
the agreement to the extent that increased payments are claimed from a 
Federal health care program.
    (ii) A first tier contractor and a downstream contractor or between 
two downstream contractors to provide or arrange for items or services, 
as long as the following four standards are met--
    (A) The parties have an agreement that:
    (1) Is set out in writing and signed by both parties;
    (2) Specifies the items and services covered by the agreement;
    (3) Is for a period of at least one year; and
    (4) Specifies that the party providing the items or services cannot 
claim payment in any form from a Federal health care program for items 
or services covered under the agreement.
    (B) In establishing the terms of the agreement, neither party gives 
or receives remuneration in return for or to induce the provision or 
acceptance of business (other than business covered by the agreement) 
for which payment may be made in whole or in part by a Federal health 
care program on a fee-for-service or cost basis.
    (C) Neither party shifts the financial burden of the agreement to 
the extent that increased payments are claimed from a Federal health 
care program.
    (D) The agreement between the eligible managed care organization and 
first tier contractor covering the items or services that are covered by 
the agreement between the parties does not involve:
    (1) A Federally qualified health center receiving supplemental 
payments;
    (2) A HMO or CMP with a cost-based contract under section 1876 of 
the Act; or
    (3) A Federally qualified HMO, unless the items or services are 
covered by a risk based contract under sections 1854 or 1876 of the Act.
    (2) For purposes of this paragraph, the following terms are defined 
as follows:
    (i) Downstream contractor means an individual or entity that has a 
subcontract directly or indirectly with a first tier contractor for the 
provision

[[Page 1046]]

or arrangement of items or services that are covered by an agreement 
between an eligible managed care organization and the first tier 
contractor.
    (ii) Eligible managed care organization \1\ means--
---------------------------------------------------------------------------

    \1\ The eligible managed care organizations in paragraphs 
(u)(2)(ii)(A)-(F) of this section are only eligible with respect to 
items or services covered by the contracts specified in those 
paragraphs.
---------------------------------------------------------------------------

    (A) A HMO or CMP with a risk or cost based contract in accordance 
with section 1876 of the Act;
    (B) Any Medicare Part C health plan that receives a capitated 
payment from Medicare and which must have its total Medicare beneficiary 
cost sharing approved by CMS under section 1854 of the Act;
    (C) Medicaid managed care organizations as defined in section 
1903(m)(1)(A) that provide or arrange for items or services for Medicaid 
enrollees under a contract in accordance with section 1903(m) of the Act 
(except for fee-for-service plans or medical savings accounts);
    (D) Any other health plans that provide or arrange for items and 
services for Medicaid enrollees in accordance with a risk-based contract 
with a State agency subject to the upper payment limits in Sec. 447.361 
of this title or an equivalent payment cap approved by the Secretary;
    (E) Programs For All Inclusive Care For The Elderly (PACE) under 
sections 1894 and 1934 of the Act, except for for-profit demonstrations 
under sections 4801(h) and 4802(h) of Pub. L. 105-33; or
    (F) A Federally qualified HMO.
    (iii) First tier contractor means an individual or entity that has a 
contract directly with an eligible managed care organization to provide 
or arrange for items or services.
    (iv) Items and services means health care items, devices, supplies 
or services or those services reasonably related to the provision of 
health care items, devices, supplies or services including, but not 
limited to, non-emergency transportation, patient education, attendant 
services, social services (e.g., case management), utilization review 
and quality assurance. Marketing and other pre-enrollment activities are 
not ``items or services'' for purposes of this section.
    (u) Price reductions offered by contractors with substantial 
financial risk to managed care organizations. (1) As used in section 
1128(B) of the Act, ``remuneration'' does not include any payment 
between:
    (i) A qualified managed care plan and a first tier contractor for 
providing or arranging for items or services, where the following five 
standards are met--
    (A) The agreement between the qualified managed care plan and first 
tier contractor must:
    (1) Be in writing and signed by the parties;
    (2) Specify the items and services covered by the agreement;
    (3) Be for a period of a least one year;
    (4) Require participation in a quality assurance program that 
promotes the coordination of care, protects against underutilization and 
specifies patient goals, including measurable outcomes where 
appropriate; and
    (5) Specify a methodology for determining payment that is 
commercially reasonable and consistent with fair market value 
established in an arms-length transaction and includes the intervals at 
which payments will be made and the formula for calculating incentives 
and penalties, if any.
    (B) If a first tier contractor has an investment interest in a 
qualified managed care plan, the investment interest must meet the 
criteria of paragraph (a)(1) of this section.
    (C) The first tier contractor must have substantial financial risk 
for the cost or utilization of services it is obligated to provide 
through one of the following four payment methodologies:
    (1) A periodic fixed payment per patient that does not take into 
account the dates services are provided, the frequency of services, or 
the extent or kind of services provided;
    (2) Percentage of premium;
    (3) Inpatient Federal health care program diagnosis-related groups 
(DRGs) (other than those for psychiatric services);
    (4) Bonus and withhold arrangements, provided--
    (i) The target payment for first tier contractors that are 
individuals or non-institutional providers is at least

[[Page 1047]]

20 percent greater than the minimum payment, and for first tier 
contractors that are institutional providers, i.e., hospitals and 
nursing homes, is at least 10 percent greater than the minimum payment;
    (ii) The amount at risk, i.e., the bonus or withhold, is earned by a 
first tier contractor in direct proportion to the ratio of the 
contractor's actual utilization to its target utilization;
    (iii) In calculating the percentage in accordance with paragraph 
(u)(1)(i)(C)(4)(i) of this section, both the target payment amount and 
the minimum payment amount include any performance bonus, e.g., payments 
for timely submission of paperwork, continuing medical education, 
meeting attendance, etc., at a level achieved by 75 percent of the first 
tier contractors who are eligible for such payments;
    (iv) Payment amounts, including any bonus or withhold amounts, are 
reasonable given the historical utilization patterns and costs for the 
same or comparable populations in similar managed care arrangements; and
    (v) Alternatively, for a first tier contractor that is a physician, 
the qualified managed care plan has placed the physician at risk for 
referral services in an amount that exceeds the substantial financial 
risk threshold set forth in 42 CFR 417.479(f) and the arrangement is in 
compliance with the stop-loss and beneficiary survey requirements of 42 
CFR 417.479(g).
    (D) Payments for items and services reimbursable by Federal health 
care program must comply with the following two standards--
    (1) The qualified managed care plan (or in the case of a self-funded 
employer plan that contracts with a qualified managed care plan to 
provide administrative services, the self-funded employer plan) must 
submit the claims directly to the Federal health care program, in 
accordance with a valid reassignment agreement, for items or services 
reimbursed by the Federal health care program. (Notwithstanding the 
foregoing, inpatient hospital services, other than psychiatric services, 
will be deemed to comply if the hospital is reimbursed by a Federal 
health care program under a DRG methodology.)
    (2) Payments to first tier contractors and any downstream 
contractors for providing or arranging for items or services reimbursed 
by a Federal health care program must be identical to payment 
arrangements to or between such parties for the same items or services 
provided to other beneficiaries with similar health status, provided 
that such payments may be adjusted where the adjustments are related to 
utilization patterns or costs of providing items or services to the 
relevant population.
    (E) In establishing the terms of an arrangement--
    (1) Neither party gives or receives remuneration in return for or to 
induce the provision or acceptance of business (other than business 
covered by the arrangement) for which payment may be made in whole or in 
part by a Federal health care program on a fee-for-service or cost 
basis; and
    (2) Neither party to the arrangement shifts the financial burden of 
such arrangement to the extent that increased payments are claimed from 
a Federal health care program.
    (ii) A first tier contractor and a downstream contractor, or between 
downstream contractors, to provide or arrange for items or services, as 
long as the following three standards are met--
    (A) Both parties are being paid for the provision or arrangement of 
items or services in accordance with one of the payment methodologies 
set out in paragraph (u)(1)(i)(C) of this section;
    (B) Payment arrangements for items and services reimbursable by a 
Federal health care program comply with paragraph (u)(1)(i)(D) of this 
section; and
    (C) In establishing the terms of an arrangement--
    (1) Neither party gives or receives remuneration in return for or to 
induce the provision or acceptance of business (other than business 
covered by the arrangement) for which payment may be made in whole or in 
part by a Federal health care program on a fee-for-service or cost 
basis; and
    (2) Neither party to the arrangement shifts the financial burden of 
the arrangement to the extent that increased payments are claimed from a 
Federal health care program.

[[Page 1048]]

    (2) For purposes of this paragraph, the following terms are defined 
as follows:
    (i) Downstream contractor means an individual or entity that has a 
subcontract directly or indirectly with a first tier contractor for the 
provision or arrangement of items or services that are covered by an 
agreement between a qualified managed care plan and the first tier 
contractor.
    (ii) First tier contractor means an individual or entity that has a 
contract directly with a qualified managed care plan to provide or 
arrange for items or services.
    (iii) Is obligated to provide for a contractor refers to items or 
services:
    (A) Provided directly by an individual or entity and its employees;
    (B) For which an individual or entity is financially responsible, 
but which are provided by downstream contractors;
    (C) For which an individual or entity makes referrals or 
arrangements; or
    (D) For which an individual or entity receives financial incentives 
based on its own, its provider group's, or its qualified managed care 
plan's performance (or combination thereof).
    (iv) Items and services means health care items, devices, supplies 
or services or those services reasonably related to the provision of 
health care items, devices, supplies or services including, but not 
limited to, non-emergency transportation, patient education, attendant 
services, social services (e.g., case management), utilization review 
and quality assurance. Marketing or other pre-enrollment activities are 
not ``items or services'' for purposes of this definition in this 
paragraph.
    (v) Minimum payment is the guaranteed amount that a provider is 
entitled to receive under an agreement with a first tier or downstream 
contractor or a qualified managed care plan.
    (vi) Qualified managed care plan means a health plan as defined in 
paragraph (l)(2) of this section that:
    (A) Provides a comprehensive range of health services;
    (B) Provides or arranges for--
    (1) Reasonable utilization goals to avoid inappropriate utilization;
    (2) An operational utilization review program;
    (3) A quality assurance program that promotes the coordination of 
care, protects against underutilization, and specifies patient goals, 
including measurable outcomes where appropriate;
    (4) Grievance and hearing procedures;
    (5) Protection of enrollees from incurring financial liability other 
than copayments and deductibles; and
    (6) Treatment for Federal health care program beneficiaries that is 
not different than treatment for other enrollees because of their status 
as Federal health care program beneficiaries; and
    (C) Covers a beneficiary population of which either--
    (1) No more than 10 percent are Medicare beneficiaries, not 
including persons for whom a Federal health care program is the 
secondary payer; or
    (2) No more than 50 percent are Medicare beneficiaries (not 
including persons for whom a Federal health care program is the 
secondary payer), provided that payment of premiums is on a periodic 
basis that does not take into account the dates services are rendered, 
the frequency of services, or the extent or kind of services rendered, 
and provided further that such periodic payments for the non-Federal 
health care program beneficiaries do not take into account the number of 
Federal health care program fee-for-service beneficiaries covered by the 
agreement or the amount of services generated by such beneficiaries.
    (vii) Target payment means the fair market value payment established 
through arms length negotiations that will be earned by an individual or 
entity that:
    (A) Is dependent on the individual or entity's meeting a utilization 
target or range of utilization targets that are set consistent with 
historical utilization rates for the same or comparable populations in 
similar managed care arrangements, whether based on its own, its 
provider group's or the qualified managed care plan's utilization (or a 
combination thereof); and
    (B) Does not include any bonus or fees that the individual or entity 
may earn from exceeding the utilization target.
    (v) Ambulance replenishing. (1) As used in section 1128B of the Act, 
``remuneration'' does not include any gift or

[[Page 1049]]

transfer of drugs or medical supplies (including linens) by a hospital 
or other receiving facility to an ambulance provider for the purpose of 
replenishing comparable drugs or medical supplies (including linens) 
used by the ambulance provider (or a first responder) in connection with 
the transport of a patient by ambulance to the hospital or other 
receiving facility if all of the standards in paragraph (v)(2) of this 
section are satisfied and all of the applicable standards in either 
paragraph (v)(3)(i), (v)(3)(ii) or (v)(3)(iii) of this section are 
satisfied. However, to qualify under paragraph (v), the ambulance that 
is replenished must be used to provide emergency ambulance services an 
average of three times per week, as measured over a reasonable period of 
time. Drugs and medical supplies (including linens) initially used by a 
first responder and replenished at the scene of the illness or injury by 
the ambulance provider that transports the patient to the hospital or 
other receiving facility will be deemed to have been used by the 
ambulance provider.
    (2) To qualify under paragraph (v) of this section, the ambulance 
replenishing arrangement must satisfy all of the following four 
conditions--
    (i)(A) Under no circumstances may the ambulance provider (or first 
responder) and the receiving facility both bill for the same replenished 
drug or supply. Replenished drugs or supplies may only be billed 
(including claiming bad debt) to a Federal health care program by either 
the ambulance provider (or first responder) or the receiving facility.
    (B) All billing or claims submission by the receiving facility, 
ambulance provider or first responder for replenished drugs and medical 
supplies used in connection with the transport of a Federal health care 
program beneficiary must comply with all applicable Federal health care 
program payment and coverage rules and regulations.
    (C) Compliance with paragraph (v)(2)(i)(B) of this section will be 
determined separately for the receiving facility and the ambulance 
provider (and first responder, if any), so long as the receiving 
facility, ambulance provider (or first responder) refrains from doing 
anything that would impede the other party or parties from meeting their 
obligations under paragraph (v)(2)(i)(B).
    (ii)(A) The receiving facility or ambulance provider, or both, must
    (1) Maintain records of the replenished drugs and medical supplies 
and the patient transport to which the replenished drugs and medical 
supplies related;
    (2) Provide a copy of such records to the other party within a 
reasonable time (unless the other party is separately maintaining 
records of the replenished drugs and medical supplies); and
    (3) Make those records available to the Secretary promptly upon 
request.
    (B) A pre-hospital care report (including, but not limited to, a 
trip sheet, patient care report or patient encounter report) prepared by 
the ambulance provider and filed with the receiving facility will meet 
the requirements of paragraph (v)(2)(ii)(A) of this section, provided 
that it documents the specific type and amount of medical supplies and 
drugs used on the patient and subsequently replenished.
    (C) For purposes of paragraph (v)(2)(ii) of this section, 
documentation may be maintained and, if required, filed with the other 
party in hard copy or electronically. If a replenishing arrangement 
includes linens, documentation need not be maintained for their 
exchange. If documentation is not maintained for the exchange of linens, 
the receiving facility will be presumed to have provided an exchange of 
comparable clean linens for soiled linens for each ambulance transport 
of a patient to the receiving facility. Records required under paragraph 
(v)(2)(ii)(A) of this section must be maintained for 5 years.
    (iii) The replenishing arrangement must not take into account the 
volume or value of any referrals or business otherwise generated between 
the parties for which payment may be made in whole or in part under any 
Federal health care program (other than the referral of the particular 
patient to whom the replenished drugs and medical supplies were 
furnished).
    (iv) The receiving facility and the ambulance provider otherwise 
comply with all Federal, State, and local laws

[[Page 1050]]

regulating ambulance services, including, but not limited to, emergency 
services, and the provision of drugs and medical supplies, including, 
but not limited to, laws relating to the handling of controlled 
substances.
    (3) To qualify under paragraph (v) of this section, the arrangement 
must satisfy all of the standards in one of the following three 
categories:
    (i) General replenishing. (A) The receiving facility must replenish 
medical supplies or drugs on an equal basis for all ambulance providers 
that bring patients to the receiving facility in any one of the 
categories described in paragraph (v)(3)(i)(A)(1), (2), or (3) of this 
section. A receiving facility may offer replenishing to one or more of 
the categories and may offer different replenishing arrangements to 
different categories, so long as the replenishing is conducted uniformly 
within each category. For example, a receiving facility may offer to 
replenish a broader array of drugs or supplies for ambulance providers 
that do no not charge for their services than for ambulance providers 
that charge for their services. Within each category, the receiving 
facility may limit its replenishing arrangements to the replenishing of 
emergency ambulance transports only. A receiving facility may offer 
replenishing to one or more of the categories--
    (1) All ambulance providers that do not bill any patient or insurer 
(including Federal health care programs) for ambulance services, 
regardless of the payor or the patient's ability to pay (i.e., ambulance 
providers, such as volunteer companies, that provide ambulance services 
without charge to any person or entity);
    (2) All not-for-profit and State or local government ambulance 
service providers (including, but not limited to, municipal and 
volunteer ambulance services providers); or
    (3) All ambulance service providers.
    (B)(1) The replenishing arrangement must be conducted in an open and 
public manner. A replenishing arrangement will be considered to be 
conducted in an open and public manner if one of the following two 
conditions are satisfied:
    (i) A written disclosure of the replenishing program is posted 
conspicuously in the receiving facility's emergency room or other 
location where the ambulance providers deliver patients and copies are 
made available upon request to ambulance providers, Government 
representatives, and members of the public (subject to reasonable 
photocopying charges). The written disclosure can take any reasonable 
form and should include the category of ambulance service providers that 
qualifies for replenishment; the drugs or medical supplies included in 
the replenishment program; and the procedures for documenting the 
replenishment. A sample disclosure form is included in appendix A to 
subpart C of this part for illustrative purposes only. No written 
contracts between the parties are required for purposes of paragraph 
(v)(3)(i)(B)(1)(i) of this section; or
    (ii) The replenishment arrangement operates in accordance with a 
plan or protocol of general application promulgated by an Emergency 
Medical Services (EMS) Council or comparable entity, agency or 
organization, provided a copy of the plan or protocol is available upon 
request to ambulance providers, Government representatives and members 
of the public (subject to reasonable photocopying charges). While 
parties are encouraged to participate in collaborative, comprehensive, 
community-wide EMS systems to improve the delivery of EMS in their local 
communities, nothing in this paragraph shall be construed as requiring 
the involvement of such organizations or the development or 
implementation of ambulance replenishment plans or protocols by such 
organizations.
    (2) Nothing in this paragraph (v)(3)(i) shall be construed as 
requiring disclosure of confidential proprietary or financial 
information related to the replenishing arrangement (including, but not 
limited to, information about cost, pricing or the volume of replenished 
drugs or supplies) to ambulance providers or members of the general 
public.
    (ii) Fair market value replenishing. (A) Except as otherwise 
provided in paragraph (v)(3)(ii)(B) of this section, the ambulance 
provider must pay the receiving facility fair market value,

[[Page 1051]]

based on an arms-length transaction, for replenished medical supplies; 
and
    (B) If payment is not made at the same time as the replenishing of 
the medical supplies, the receiving facility and the ambulance provider 
must make commercially reasonable payment arrangements in advance.
    (iii) Government mandated replenishing. The replenishing arrangement 
is undertaken in accordance with a State or local statute, ordinance, 
regulation or binding protocol that requires hospitals or receiving 
facilities in the area subject to such requirement to replenish 
ambulances that deliver patients to the hospital with drugs or medical 
supplies (including linens) that are used during the transport of that 
patient.
    (4) For purposes of paragraph (v) of this section--
    (i) A receiving facility is a hospital or other facility that 
provides emergency medical services.
    (ii) An ambulance provider is a provider or supplier of ambulance 
transport services that provides emergency ambulance services. The term 
does not include a provider of ambulance transport services that 
provides only non-emergency transport services.
    (iii) A first responder includes, but is not limited to, a fire 
department, paramedic service or search and rescue squad that responds 
to an emergency call (through 9-1-1 or other emergency access number) 
and treats the patient, but does not transport the patient to the 
hospital or other receiving facility.
    (iv) An emergency ambulance service is a transport by ambulance 
initiated as a result of a call through 9-1-1 or other emergency access 
number or a call from another acute care facility unable to provide the 
higher level care required by the patient and available at the receiving 
facility.
    (v) Medical supplies includes linens, unless otherwise provided.
    (w) Health centers. As used in section 1128B of the Act, 
``remuneration'' does not include the transfer of any goods, items, 
services, donations or loans (whether the donation or loan is in cash or 
in-kind), or combination thereof from an individual or entity to a 
health center (as defined in this paragraph), as long as the following 
nine standards are met--
    (1)(i) The transfer is made pursuant to a contract, lease, grant, 
loan, or other agreement that--
    (A) Is set out in writing;
    (B) Is signed by the parties; and
    (C) Covers, and specifies the amount of, all goods, items, services, 
donations, or loans to be provided by the individual or entity to the 
health center.
    (ii) The amount of goods, items, services, donations, or loans 
specified in the agreement in accordance with paragraph (w)(1)(i)(C) of 
this section may be a fixed sum, fixed percentage, or set forth by a 
fixed methodology. The amount may not be conditioned on the volume or 
value of Federal health care program business generated between the 
parties. The written agreement will be deemed to cover all goods, items, 
services, donations, or loans provided by the individual or entity to 
the health center as required by paragraph (w)(1)(i)(C) of this section 
if all separate agreements between the individual or entity and the 
health center incorporate each other by reference or if they cross-
reference a master list of agreements that is maintained centrally, is 
kept up to date, and is available for review by the Secretary upon 
request. The master list should be maintained in a manner that preserves 
the historical record of arrangements.
    (2) The goods, items, services, donations, or loans are medical or 
clinical in nature or relate directly to services provided by the health 
center as part of the scope of the health center's section 330 grant 
(including, by way of example, billing services, administrative support 
services, technology support, and enabling services, such as case 
management, transportation, and translation services, that are within 
the scope of the grant).
    (3) The health center reasonably expects the arrangement to 
contribute meaningfully to the health center's ability to maintain or 
increase the availability, or enhance the quality, of services provided 
to a medically underserved population served by the health center, and 
the health center documents the basis for the reasonable expectation 
prior to entering the arrangement. The documentation must be made 
available to the Secretary upon request.

[[Page 1052]]

    (4) At reasonable intervals, but at least annually, the health 
center must re-evaluate the arrangement to ensure that the arrangement 
is expected to continue to satisfy the standard set forth in paragraph 
(w)(3) of this section, and must document the re-evaluation 
contemporaneously. The documentation must be made available to the 
Secretary upon request. Arrangements must not be renewed or renegotiated 
unless the health center reasonably expects the standard set forth in 
paragraph (w)(3) of this section to be satisfied in the next agreement 
term. Renewed or renegotiated agreements must comply with the 
requirements of paragraph (w)(3) of this section.
    (5) The individual or entity does not (i) Require the health center 
(or its affiliated health care professionals) to refer patients to a 
particular individual or entity, or
    (ii) restrict the health center (or its affiliated health care 
professionals) from referring patients to any individual or entity.
    (6) Individuals and entities that offer to furnish goods, items, or 
services without charge or at a reduced charge to the health center must 
furnish such goods, items, or services to all patients from the health 
center who clinically qualify for the goods, items, or services, 
regardless of the patient's payor status or ability to pay. The 
individual or entity may impose reasonable limits on the aggregate 
volume or value of the goods, items, or services furnished under the 
arrangement with the health center, provided such limits do not take 
into account a patient's payor status or ability to pay.
    (7) The agreement must not restrict the health center's ability, if 
it chooses, to enter into agreements with other providers or suppliers 
of comparable goods, items, or services, or with other lenders or 
donors. Where a health center has multiple individuals or entities 
willing to offer comparable remuneration, the health center must employ 
a reasonable methodology to determine which individuals or entities to 
select and must document its determination. In making these 
determinations, health centers should look to the procurement standards 
for beneficiaries of Federal grants set forth in 45 CFR 75.326 through 
75.340.
    (8) The health center must provide effective notification to 
patients of their freedom to choose any willing provider or supplier. In 
addition, the health center must disclose the existence and nature of an 
agreement under paragraph (w)(1) of this section to any patient who 
inquires. The health center must provide such notification or disclosure 
in a timely fashion and in a manner reasonably calculated to be 
effective and understood by the patient.
    (9) The health center may, at its option, elect to require that an 
individual or entity charge a referred health center patient the same 
rate it charges other similarly situated patients not referred by the 
health center or that the individual or entity charge a referred health 
center patient a reduced rate (where the discount applies to the total 
charge and not just to the cost-sharing portion owed by an insured 
patient).

    Note to paragraph (w): For purposes of this paragraph, the term 
``health center'' means a Federally Qualified Health Center under 
section 1905(l)(2)(B)(i) or 1905(l)(2)(B)(ii) of the Act, and 
``medically underserved population'' means a medically underserved 
population as defined in regulations at 42 CFR 51c.102(e).

    (x) Electronic prescribing items and services. As used in section 
1128B of the Act, ``remuneration'' does not include nonmonetary 
remuneration (consisting of items and services in the form of hardware, 
software, or information technology and training services) necessary and 
used solely to receive and transmit electronic prescription information, 
if all of the following conditions are met:
    (1) The items and services are provided by a--
    (i) Hospital to a physician who is a member of its medical staff;
    (ii) Group practice to a prescribing health care professional who is 
a member of the group practice; and
    (iii) A PDP sponsor or MA organization to pharmacists and pharmacies 
participating in the network of such sponsor or organization and to 
prescribing health care professionals.
    (2) The items and services are provided as part of, or are used to 
access,

[[Page 1053]]

an electronic prescription drug program that meets the applicable 
standards under Medicare Part D at the time the items and services are 
provided.
    (3) The donor (or any person on the donor's behalf) does not take 
any action to limit or restrict the use or compatibility of the items or 
services with other electronic prescribing or electronic health records 
systems.
    (4) For items or services that are of the type that can be used for 
any patient without regard to payor status, the donor does not restrict, 
or take any action to limit, the recipient's right or ability to use the 
items or services for any patient.
    (5) Neither the recipient nor the recipient's practice (or any 
affiliated individual or entity) makes the receipt of items or services, 
or the amount or nature of the items or services, a condition of doing 
business with the donor.
    (6) Neither the eligibility of a beneficiary for the items or 
services, nor the amount or nature of the items or services, is 
determined in a manner that takes into account the volume or value of 
referrals or other business generated between the parties.
    (7) The arrangement is set forth in a written agreement that--
    (i) Is signed by the parties;
    (ii) Specifies the items and services being provided and the donor's 
cost of the items and services; and
    (iii) Covers all of the electronic prescribing items and services to 
be provided by the donor (or affiliated parties). This requirement will 
be met if all separate agreements between the donor (and affiliated 
parties) and the beneficiary incorporate each other by reference or if 
they cross-reference a master list of agreements that is maintained and 
updated centrally and is available for review by the Secretary upon 
request. The master list should be maintained in a manner that preserves 
the historical record of agreements.
    (8) The donor does not have actual knowledge of, and does not act in 
reckless disregard or deliberate ignorance of, the fact that the 
beneficiary possesses or has obtained items or services equivalent to 
those provided by the donor.

    Note to paragraph (x): For purposes of paragraph (x) of this 
section, group practice shall have the meaning set forth at 42 CFR 
411.352; member of the group practice shall mean all persons covered by 
the definition of ``member of the group or member of a group practice'' 
at 42 CFR 411.351, as well as other prescribing health care 
professionals who are owners or employees of the group practice; 
prescribing health care professional shall mean a physician or other 
health care professional licensed to prescribe drugs in the State in 
which the drugs are dispensed; PDP sponsor or MA organization shall have 
the meanings set forth at 42 CFR 423.4 and 422.2, respectively; 
prescription information shall mean information about prescriptions for 
drugs or for any other item or service normally accomplished through a 
written prescription; and electronic health record shall mean a 
repository of consumer health status information in computer processable 
form used for clinical diagnosis and treatment for a broad array of 
clinical conditions.

    (y) Electronic health records items and services. As used in section 
1128B of the Act, ``remuneration'' does not include nonmonetary 
remuneration (consisting of items and services in the form of software 
or information technology and training services, including cybersecurity 
software and services) necessary and used predominantly to create, 
maintain, transmit, receive, or protect electronic health records, if 
all of the conditions in paragraphs (y)(1) through (13) of this section 
are met:
    (1) The items and services are provided to an individual or entity 
engaged in the delivery of health care by:
    (i) An individual or entity, other than a laboratory company, that:
    (A) Provides services covered by a Federal health care program and 
submits claims or requests for payment, either directly or through 
reassignment, to the Federal health care program; or
    (B) Is comprised of the types of individuals or entities in 
paragraph (y)(1)(i)(A) of this section; or
    (ii) A health plan.
    (2) The software is interoperable at the time it is provided to the 
recipient. For purposes of this paragraph (y)(2) of this section, 
software is deemed to be interoperable if, on the date it is provided to 
the recipient, it is certified by a certifying body authorized by the 
National Coordinator for Health Information Technology to certification 
criteria identified in the then-applicable version of 45 CFR part 170.

[[Page 1054]]

    (3) [Reserved]
    (4) Neither the recipient nor the recipient's practice (or any 
affiliated individual or entity) makes the receipt of items or services, 
or the amount or nature of the items or services, a condition of doing 
business with the donor.
    (5) Neither the eligibility of a recipient for the items or 
services, nor the amount or nature of the items or services, is 
determined in a manner that directly takes into account the volume or 
value of referrals or other business generated between the parties. For 
the purposes of this paragraph (y)(5), the determination is deemed not 
to directly take into account the volume or value of referrals or other 
business generated between the parties if any one of the following 
conditions is met:
    (i) The determination is based on the total number of prescriptions 
written by the beneficiary (but not the volume or value of prescriptions 
dispensed or paid by the donor or billed to a Federal health care 
program);
    (ii) The determination is based on the size of the recipient's 
medical practice (for example, total patients, total patient encounters, 
or total relative value units);
    (iii) The determination is based on the total number of hours that 
the recipient practices medicine;
    (iv) The determination is based on the recipient's overall use of 
automated technology in his or her medical practice (without specific 
reference to the use of technology in connection with referrals made to 
the donor);
    (v) The determination is based on whether the recipient is a member 
of the donor's medical staff, if the donor has a formal medical staff;
    (vi) The determination is based on the level of uncompensated care 
provided by the recipient; or
    (vii) The determination is made in any reasonable and verifiable 
manner that does not directly take into account the volume or value of 
referrals or other business generated between the parties.
    (6) The arrangement is set forth in a written agreement that --
    (i) Is signed by the parties;
    (ii) Specifies the items and services being provided, the donor's 
cost of those items and services, and the amount of the recipient's 
contribution; and
    (iii) Covers all of the electronic health records items and services 
to be provided by the donor (or any affiliate). This requirement will be 
met if all separate agreements between the donor (and affiliated 
parties) and the beneficiary incorporate each other by reference or if 
they cross-reference a master list of agreements that is maintained and 
updated centrally and is available for review by the Secretary upon 
request. The master list should be maintained in a manner that preserves 
the historical record of agreements.
    (7) [Reserved]
    (8) For items or services that are of the type that can be used for 
any patient without regard to payor status, the donor does not restrict, 
or take any action to limit, the recipient's right or ability to use the 
items or services for any patient.
    (9) The items and services do not include staffing of the 
recipient's office and are not used primarily to conduct personal 
business or business unrelated to the recipient's clinical practice or 
clinical operations.
    (10) [Reserved]
    (11) The recipient pays 15 percent of the donor's cost for the items 
and services. The following conditions apply to such contribution:
    (i) If the donation is the initial donation of EHR items and 
services, or the replacement of part or all of an existing system of EHR 
items and services, the recipient must pay 15 percent of the donor's 
cost before receiving the items and services. The contribution for 
updates to previously donated EHR items and services need not be paid in 
advance of receiving the update; and
    (ii) The donor (or any affiliated individual or entity) does not 
finance the recipient's payment or loan funds to be used by the 
recipient to pay for the items and services.
    (12) The donor does not shift the costs of the items or services to 
any Federal health care program.
    (13) [Reserved]
    (14) For purposes of this paragraph (y), the following definitions 
apply:
    (i) Cybersecurity means the process of protecting information by 
preventing,

[[Page 1055]]

detecting, and responding to cyberattacks.
    (ii) Health plan shall have the meaning set forth at Sec. 
1001.952(l)(2).
    (iii) Interoperable shall mean able to:
    (A) Securely exchange data with and use data from other health 
information technology; and
    (B) Allow for complete access, exchange, and use of all 
electronically accessible health information for authorized use under 
applicable State or Federal law.
    (iv) Electronic health record shall mean a repository of consumer 
health status information in computer processable form used for clinical 
diagnosis and treatment for a broad array of clinical conditions.
    (z) Federally Qualified Health Centers and Medicare Advantage 
Organizations. As used in section 1128B of the Act, ``remuneration'' 
does not include any remuneration between a federally qualified health 
center (or an entity controlled by such a health center) and a Medicare 
Advantage organization pursuant to a written agreement described in 
section 1853(a)(4) of the Act.
    (aa) Medicare Coverage Gap Discount Program. As used in section 
1128B of the Act, ``remuneration'' does not include a discount in the 
price of a drug when the discount is furnished to a beneficiary under 
the Medicare Coverage Gap Discount Program established in section 1860D-
14A of the Act, as long as all the following requirements are met:
    (1) The discounted drug meets the definition of ``applicable drug'' 
set forth in section 1860D-14A(g) of the Act;
    (2) The beneficiary receiving the discount meets the definition of 
``applicable beneficiary'' set forth in section 1860D-14A(g) of the Act; 
and
    (3) The manufacturer of the drug participates in, and is in 
compliance with the requirements of, the Medicare Coverage Gap Discount 
Program.
    (bb) Local Transportation. As used in section 1128B of the Act, 
``remuneration'' does not include free or discounted local 
transportation made available by an eligible entity (as defined in this 
paragraph (bb)):
    (1) To Federal health care program beneficiaries if all the 
following conditions are met:
    (i) The availability of the free or discounted local transportation 
services--
    (A) Is set forth in a policy, which the eligible entity applies 
uniformly and consistently; and
    (B) Is not determined in a manner related to the past or anticipated 
volume or value of Federal health care program business;
    (ii) The free or discounted local transportation services are not 
air, luxury, or ambulance-level transportation;
    (iii) The eligible entity does not publicly market or advertise the 
free or discounted local transportation services, no marketing of health 
care items and services occurs during the course of the transportation 
or at any time by drivers who provide the transportation, and drivers or 
others arranging for the transportation are not paid on a per-
beneficiary-transported basis;
    (iv) The eligible entity makes the free or discounted transportation 
available only:
    (A) To an individual who is:
    (1) An established patient (as defined in this paragraph (bb)) of 
the eligible entity that is providing the free or discounted 
transportation, if the eligible entity is a provider or supplier of 
health care services; and
    (2) An established patient of the provider or supplier to or from 
which the individual is being transported;
    (B) Within 25 miles of the health care provider or supplier to or 
from which the patient would be transported, or within 75 miles if the 
patient resides in a rural area, as defined in this paragraph (bb) 
except that, if the patient is discharged from an inpatient facility 
following inpatient admission or released from a hospital after being 
placed in observation status for at least 24 hours and transported to 
the patient's residence, or another residence of the patient's choice, 
the mileage limits in this paragraph (bb)(1)(iv)(B) shall not apply; and
    (C) For the purpose of obtaining medically necessary items and 
services.
    (v) The eligible entity that makes the transportation available 
bears the costs of the free or discounted local transportation services 
and does not shift the burden of these costs onto any

[[Page 1056]]

Federal health care program, other payers, or individuals; and
    (2) In the form of a ``shuttle service'' (as defined in this 
paragraph (bb)) if all of the following conditions are met:
    (i) The shuttle service is not air, luxury, or ambulance-level 
transportation;
    (ii) The shuttle service is not marketed or advertised (other than 
posting necessary route and schedule details), no marketing of health 
care items and services occurs during the course of the transportation 
or at any time by drivers who provide the transportation, and drivers or 
others arranging for the transportation are not paid on a per-
beneficiary-transported basis;
    (iii) The eligible entity makes the shuttle service available only 
within the eligible entity's local area, meaning there are no more than 
25 miles from any stop on the route to any stop at a location where 
health care items or services are provided, except that if a stop on the 
route is in a rural area, the distance may be up to 75 miles between 
that stop and any providers or suppliers on the route;
    (iv) The eligible entity that makes the shuttle service available 
bears the costs of the free or discounted shuttle services and does not 
shift the burden of these costs onto any Federal health care program, 
other payers, or individuals.
    (3) For purposes of this paragraph (bb), the following definitions 
apply:
    (i) An eligible entity is any individual or entity, except for 
individuals or entities (or family members or others acting on their 
behalf) that primarily supply health care items.
    (ii) An established patient is a person who has selected and 
initiated contact to schedule an appointment with a provider or 
supplier, or who previously has attended an appointment with the 
provider or supplier.
    (iii) A shuttle service is a vehicle that runs on a set route, on a 
set schedule.
    (iv) A rural area is an area that is not an urban area, as defined 
in paragraph (bb)(3)(v) of this section.
    (v) An urban area is:
    (A) A Metropolitan Statistical Area (MSA) or New England County 
Metropolitan Area (NECMA), as defined by the Executive Office of 
Management and Budget; or
    (B) The following New England counties, which are deemed to be parts 
of urban areas under section 601(g) of the Social Security Amendments of 
1983 (Pub. L. 98-21, 42 U.S.C. 1395ww (note)): Litchfield County, 
Connecticut; York County, Maine; Sagadahoc County, Maine; Merrimack 
County, New Hampshire; and Newport County, Rhode Island.
    (cc)-(dd) [Reserved]
    (ee) Care coordination arrangements to improve quality, health 
outcomes, and efficiency. As used in section 1128B of the Act, 
``remuneration'' does not include the exchange of anything of value 
between a VBE and VBE participant or between VBE participants pursuant 
to a value-based arrangement if all of the standards in paragraphs 
(ee)(1) through (13) of this section are met:
    (1) The remuneration exchanged:
    (i) Is in-kind;
    (ii) Is used predominantly to engage in value-based activities that 
are directly connected to the coordination and management of care for 
the target patient population and does not result in more than 
incidental benefits to persons outside of the target patient population; 
and
    (iii) Is not exchanged or used:
    (A) More than incidentally for the recipient's billing or financial 
management services; or
    (B) For the purpose of marketing items or services furnished by the 
VBE or a VBE participant to patients or for patient recruitment 
activities.
    (2) The value-based arrangement is commercially reasonable, 
considering both the arrangement itself and all value-based arrangements 
within the VBE.
    (3) The terms of the value-based arrangement are set forth in 
writing and signed by the parties in advance of, or contemporaneous 
with, the commencement of the value-based arrangement and any material 
change to the value-based arrangement. The writing states at a minimum:
    (i) The value-based purpose(s) of the value-based activities 
provided for in the value-based arrangement;

[[Page 1057]]

    (ii) The value-based activities to be undertaken by the parties to 
the value-based arrangement;
    (iii) The term of the value-based arrangement;
    (iv) The target patient population;
    (v) A description of the remuneration;
    (vi) Either the offeror's cost for the remuneration and the 
reasonable accounting methodology used by the offeror to determine its 
cost, or the fair market value of the remuneration;
    (vii) The percentage and amount contributed by the recipient;
    (viii) If applicable, the frequency of the recipient's contribution 
payments for ongoing costs; and
    (ix) The outcome or process measure(s) against which the recipient 
will be measured.
    (4) The parties to the value-based arrangement establish one or more 
legitimate outcome or process measures that:
    (i) The parties reasonably anticipate will advance the coordination 
and management of care for the target patient population based on 
clinical evidence or credible medical or health sciences support;
    (ii) Include one or more benchmarks that are related to improving or 
maintaining improvements in the coordination and management of care for 
the target patient population;
    (iii) Are monitored, periodically assessed, and prospectively 
revised as necessary to ensure that the measure and its benchmark 
continue to advance the coordination and management of care of the 
target patient population;
    (iv) Relate to the remuneration exchanged under the value-based 
arrangement; and
    (v) Are not based solely on patient satisfaction or patient 
convenience.
    (5) The offeror of the remuneration does not take into account the 
volume or value of, or condition the remuneration on:
    (i) Referrals of patients who are not part of the target patient 
population; or
    (ii) Business not covered under the value-based arrangement.
    (6) The recipient pays at least 15 percent of the offeror's cost for 
the remuneration, using any reasonable accounting methodology, or the 
fair market value of the in-kind remuneration. If it is a one-time cost, 
the recipient makes such contribution in advance of receiving the in-
kind remuneration. If it is an ongoing cost, the recipient makes such 
contribution at reasonable, regular intervals.
    (7) The value-based arrangement does not:
    (i) Limit the VBE participant's ability to make decisions in the 
best interests of its patients;
    (ii) Direct or restrict referrals to a particular provider, 
practitioner, or supplier if:
    (A) A patient expresses a preference for a different practitioner, 
provider, or supplier;
    (B) The patient's payor determines the provider, practitioner, or 
supplier; or
    (C) Such direction or restriction is contrary to applicable law 
under titles XVIII and XIX of the Act; or
    (iii) Induce parties to furnish medically unnecessary items or 
services, or reduce or limit medically necessary items or services 
furnished to any patient.
    (8) The exchange of remuneration by a limited technology participant 
and another VBE participant or the VBE must not be conditioned on any 
recipient's exclusive use or minimum purchase of any item or service 
manufactured, distributed, or sold by the limited technology 
participant.
    (9) The VBE, a VBE participant in the value-based arrangement acting 
on the VBE's behalf, or the VBE's accountable body or responsible person 
reasonably monitors and assesses the following and reports the 
monitoring and assessment of the following to the VBE's accountable body 
or responsible person, as applicable, no less frequently than annually 
or at least once during the term of the value-based arrangement for 
arrangements with terms of less than 1 year:
    (i) The coordination and management of care for the target patient 
population in the value-based arrangement;
    (ii) Any deficiencies in the delivery of quality care under the 
value-based arrangement; and

[[Page 1058]]

    (iii) Progress toward achieving the legitimate outcome or process 
measure(s) in the value-based arrangement.
    (10) If the VBE's accountable body or responsible person determines, 
based on the monitoring and assessment conducted pursuant to paragraph 
(ee)(9) of this section, that the value-based arrangement has resulted 
in material deficiencies in quality of care or is unlikely to further 
the coordination and management of care for the target patient 
population, the parties must within 60 days either:
    (i) Terminate the arrangement; or
    (ii) Develop and implement a corrective action plan designed to 
remedy the deficiencies within 120 days, and if the corrective action 
plan fails to remedy the deficiencies within 120 days, terminate the 
value-based arrangement.
    (11) The offeror does not and should not know that the remuneration 
is likely to be diverted, resold, or used by the recipient for an 
unlawful purpose.
    (12) For a period of at least 6 years, the VBE or VBE participant 
makes available to the Secretary, upon request, all materials and 
records sufficient to establish compliance with the conditions of this 
paragraph (ee).
    (13) The remuneration is not exchanged by:
    (i) A pharmaceutical manufacturer, distributor, or wholesaler;
    (ii) A pharmacy benefit manager;
    (iii) A laboratory company;
    (iv) A pharmacy that primarily compounds drugs or primarily 
dispenses compounded drugs;
    (v) Except to the extent the entity is a limited technology 
participant, a manufacturer of a device or medical supply;
    (vi) Except to the extent the entity or individual is a limited 
technology participant, an entity or individual that sells or rents 
durable medical equipment, prosthetics, orthotics, or supplies covered 
by a Federal health care program (other than a pharmacy or a physician, 
provider, or other entity that primarily furnishes services); or
    (vii) A medical device distributor or wholesaler that is not 
otherwise a manufacturer of a device or medical supplies.
    (14) For purposes of this paragraph (ee), the following definitions 
apply:
    (i) Coordination and management of care (or coordinating and 
managing care) means the deliberate organization of patient care 
activities and sharing of information between two or more VBE 
participants, one or more VBE participants and the VBE, or one or more 
VBE participants and patients, that is designed to achieve safer, more 
effective, or more efficient care to improve the health outcomes of the 
target patient population.
    (ii) Digital health technology means hardware, software, or services 
that electronically capture, transmit, aggregate, or analyze data and 
that are used for the purpose of coordinating and managing care; such 
term includes any internet or other connectivity service that is 
necessary and used to enable the operation of the item or service for 
that purpose.
    (iii) Limited technology participant means a VBE participant that 
exchanges digital health technology with another VBE participant or a 
VBE and that is:
    (A) A manufacturer of a device or medical supply, but not including 
a manufacturer of a device or medical supply that was obligated under 42 
CFR 403.906 to report one or more ownership or investment interests held 
by a physician or an immediate family member during the preceding 
calendar year, or that reasonably anticipates that it will be obligated 
to report one or more ownership or investment interests held by a 
physician or an immediate family member during the present calendar year 
(for purposes of this paragraph, the terms ``ownership or investment 
interest,'' ``physician,'' and ``immediate family member'' have the same 
meaning as set forth in 42 CFR 403.902); or
    (B) An entity or individual that sells or rents durable medical 
equipment, prosthetics, orthotics, or supplies covered by a Federal 
health care program (other than a pharmacy or a physician, provider, or 
other entity that primarily furnishes services).
    (iv) Manufacturer of a device or medical supply means an entity that 
meets

[[Page 1059]]

the definition of applicable manufacturer in 42 CFR 403.902 because it 
is engaged in the production, preparation, propagation, compounding, or 
conversion of a device or medical supply that meets the definition of 
covered drug, device, biological, or medical supply in 42 CFR 403.902, 
but not including entities under common ownership with such entity.
    (v) Target patient population means an identified patient population 
selected by the VBE or its VBE participants using legitimate and 
verifiable criteria that:
    (A) Are set out in writing in advance of the commencement of the 
value-based arrangement; and
    (B) Further the value-based enterprise's value-based purpose(s).
    (vi) Value-based activity. (A) Means any of the following 
activities, provided that the activity is reasonably designed to achieve 
at least one value-based purpose of the value-based enterprise:
    (1) The provision of an item or service;
    (2) The taking of an action; or
    (3) The refraining from taking an action; and
    (B) Does not include the making of a referral.
    (vii) Value-based arrangement means an arrangement for the provision 
of at least one value-based activity for a target patient population to 
which the only parties are:
    (A) The value-based enterprise and one or more of its VBE 
participants; or
    (B) VBE participants in the same value-based enterprise.
    (viii) Value-based enterprise or VBE means two or more VBE 
participants:
    (A) Collaborating to achieve at least one value-based purpose;
    (B) Each of which is a party to a value-based arrangement with the 
other or at least one other VBE participant in the value-based 
enterprise;
    (C) That have an accountable body or person responsible for 
financial and operational oversight of the value-based enterprise; and
    (D) That have a governing document that describes the value-based 
enterprise and how the VBE participants intend to achieve its value-
based purpose(s).
    (ix) Value-based enterprise participant or VBE participant means an 
individual or entity that engages in at least one value-based activity 
as part of a value-based enterprise, other than a patient acting in 
their capacity as a patient.
    (x) Value-based purpose means:
    (A) Coordinating and managing the care of a target patient 
population;
    (B) Improving the quality of care for a target patient population;
    (C) Appropriately reducing the costs to or growth in expenditures of 
payors without reducing the quality of care for a target patient 
population; or
    (D) Transitioning from health care delivery and payment mechanisms 
based on the volume of items and services provided to mechanisms based 
on the quality of care and control of costs of care for a target patient 
population.
    (ff) Value-based arrangements with substantial downside financial 
risk. As used in section 1128B of the Act, ``remuneration'' does not 
include the exchange of payments or anything of value between a VBE and 
a VBE participant pursuant to a value-based arrangement if all of the 
following standards in paragraphs (ff)(1) through (8) of this section 
are met:
    (1) The remuneration is not exchanged by:
    (i) A pharmaceutical manufacturer, distributor, or wholesaler;
    (ii) A pharmacy benefit manager;
    (iii) A laboratory company;
    (iv) A pharmacy that primarily compounds drugs or primarily 
dispenses compounded drugs;
    (v) A manufacturer of a device or medical supply;
    (vi) An entity or individual that sells or rents durable medical 
equipment, prosthetics, orthotics, or supplies covered by a Federal 
health care program (other than a pharmacy or a physician, provider, or 
other entity that primarily furnishes services); or
    (vii) A medical device distributor or wholesaler that is not 
otherwise a manufacturer of a device or medical supplies.
    (2) The VBE (directly or through a VBE participant, other than a 
payor, acting on the VBE's behalf) has assumed through a written 
contract or a value-based arrangement (or has entered into a written 
contract or a

[[Page 1060]]

value-based arrangement to assume in the next 6 months) substantial 
downside financial risk from a payor for a period of at least 1 year.
    (3) The VBE participant (unless the VBE participant is the payor 
from which the VBE is assuming risk) is at risk for a meaningful share 
of the VBE's substantial downside financial risk for providing or 
arranging for the provision of items and services for the target patient 
population.
    (4) The remuneration provided by, or shared among, the VBE and VBE 
participant:
    (i) Is directly connected to one or more of the VBE's value-based 
purposes, at least one of which must be a value-based purpose defined in 
Sec. 1001.952(ee)(14)(x)(A), (B), or (C);
    (ii) Unless exchanged pursuant to risk methodologies defined in 
paragraph (ff)(9)(i) or (ii) of this section, is used predominantly to 
engage in value-based activities that are directly connected to the 
items and services for which the VBE has assumed (or has entered into a 
written contract or value-based arrangement to assume in the next 6 
months) substantial downside financial risk;
    (iii) Does not include the offer or receipt of an ownership or 
investment interest in an entity or any distributions related to such 
ownership or investment interest; and
    (iv) Is not exchanged or used for the purpose of marketing items or 
services furnished by the VBE or a VBE participant to patients or for 
patient recruitment activities.
    (5) The value-based arrangement is set forth in writing, is signed 
by the parties in advance of, or contemporaneous with, the commencement 
of the value-based arrangement and any material change to the value-
based arrangement, and specifies all material terms including:
    (i) Terms evidencing that the VBE is at substantial downside 
financial risk or will assume such risk in the next 6 months for the 
target patient population;
    (ii) A description of the manner in which the VBE participant 
(unless the VBE participant is the payor from which the VBE is assuming 
risk) has a meaningful share of the VBE's substantial downside financial 
risk; and
    (iii) The value-based activities, the target patient population, and 
the type of remuneration exchanged.
    (6) The VBE or VBE participant offering the remuneration does not 
take into account the volume or value of, or condition the remuneration 
on:
    (i) Referrals of patients who are not part of the target patient 
population; or
    (ii) Business not covered under the value-based arrangement.
    (7) The value-based arrangement does not:
    (i) Limit the VBE participant's ability to make decisions in the 
best interests of its patients;
    (ii) Direct or restrict referrals to a particular provider, 
practitioner, or supplier if:
    (A) A patient expresses a preference for a different practitioner, 
provider, or supplier;
    (B) The patient's payor determines the provider, practitioner, or 
supplier; or
    (C) Such direction or restriction is contrary to applicable law 
under titles XVIII and XIX of the Act; or
    (iii) Induce parties to reduce or limit medically necessary items or 
services furnished to any patient.
    (8) For a period of at least 6 years, the VBE or VBE participant 
makes available to the Secretary, upon request, all materials and 
records sufficient to establish compliance with the conditions of this 
paragraph (ff).
    (9) For purposes of this paragraph (ff), the following definitions 
apply:
    (i) Substantial downside financial risk means:
    (A) Financial risk equal to at least 30 percent of any loss, where 
losses and savings are calculated by comparing current expenditures for 
all items and services that are covered by the applicable payor and 
furnished to the target patient population to a bona fide benchmark 
designed to approximate the expected total cost of such care;
    (B) Financial risk equal to at least 20 percent of any loss, where:
    (1) Losses and savings are calculated by comparing current 
expenditures for all items and services furnished to the target patient 
population pursuant to a

[[Page 1061]]

defined clinical episode of care that are covered by the applicable 
payor to a bona fide benchmark designed to approximate the expected 
total cost of such care for the defined clinical episode of care; and
    (2) The parties design the clinical episode of care to cover items 
and services collectively furnished in more than one care setting; or
    (C) The VBE receives from the payor a prospective, per-patient 
payment that is:
    (1) Designed to produce material savings; and
    (2) Paid on a monthly, quarterly, or annual basis for a predefined 
set of items and services furnished to the target patient population, 
designed to approximate the expected total cost of expenditures for the 
predefined set of items and services.
    (ii) Meaningful share means the VBE participant:
    (A) Assumes two-sided risk for at least 5 percent of the losses and 
savings, as applicable, realized by the VBE pursuant to its assumption 
of substantial downside financial risk; or
    (B) Receives from the VBE a prospective, per-patient payment on a 
monthly, quarterly, or annual basis for a predefined set of items and 
services furnished to the target patient population, designed to 
approximate the expected total cost of expenditures for the predefined 
set of items and services, and does not claim payment in any form from 
the payor for the predefined items and services.
    (iii) Manufacturer of a device or medical supply, target patient 
population, value-based activity, value-based arrangement, value-based 
enterprise, value-based purpose, and VBE participant shall have the 
meaning set forth in paragraph (ee) of this section.
    (gg) Value-based arrangements with full financial risk. As used in 
section 1128B of the Act, ``remuneration'' does not include the exchange 
of payments or anything of value between the VBE and a VBE participant 
pursuant to a value-based arrangement if all of the standards in 
paragraphs (gg)(1) through (9) of this section are met:
    (1) The remuneration is not exchanged by:
    (i) A pharmaceutical manufacturer, distributor, or wholesaler;
    (ii) A pharmacy benefit manager;
    (iii) A laboratory company;
    (iv) A pharmacy that primarily compounds drugs or primarily 
dispenses compounded drugs;
    (v) A manufacturer of a device or medical supply;
    (vi) An entity or individual that sells or rents durable medical 
equipment, prosthetics, orthotics, or supplies covered by a Federal 
health care program (other than a pharmacy or a physician, provider, or 
other entity that primarily furnishes services); or
    (vii) A medical device distributor or wholesaler that is not 
otherwise a manufacturer of a device or medical supplies.
    (2) The VBE (directly or through a VBE participant, other than a 
payor, acting on behalf of the VBE) has assumed through a written 
contract or a value-based arrangement (or has entered into a written 
contract or a value-based arrangement to assume in the next 1 year) full 
financial risk from a payor.
    (3) The value-based arrangement is set forth in writing, is signed 
by the parties, and specifies all material terms, including the value-
based activities and the term.
    (4) The VBE participant (unless the VBE participant is a payor) does 
not claim payment in any form from the payor for items or services 
covered under the contract or value-based arrangement between the VBE 
and the payor described in paragraph (2).
    (5) The remuneration provided by, or shared among, the VBE and VBE 
participant:
    (i) Is directly connected to one or more of the VBE's value-based 
purposes;
    (ii) Does not include the offer or receipt of an ownership or 
investment interest in an entity or any distributions related to such 
ownership or investment interest; and
    (iii) Is not exchanged or used for the purpose of marketing items or 
services furnished by the VBE or a VBE participant to patients or for 
patient recruitment activities.
    (6) The value-based arrangement does not induce parties to reduce or 
limit

[[Page 1062]]

medically necessary items or services furnished to any patient.
    (7) The VBE or VBE participant offering the remuneration does not 
take into account the volume or value of, or condition the remuneration 
on:
    (i) Referrals of patients who are not part of the target patient 
population; or
    (ii) Business not covered under the value-based arrangement.
    (8) The VBE provides or arranges for a quality assurance program for 
services furnished to the target patient population that:
    (i) Protects against underutilization; and
    (ii) Assesses the quality of care furnished to the target patient 
population.
    (9) For a period of at least 6 years, the VBE or VBE participant 
makes available to the Secretary, upon request, all materials and 
records sufficient to establish compliance with the conditions of this 
paragraph (gg).
    (10) For purposes of this paragraph (gg), the following definitions 
apply:
    (i) Full financial risk means the VBE is financially responsible on 
a prospective basis for the cost of all items and services covered by 
the applicable payor for each patient in the target patient population 
for a term of at least 1 year.
    (ii) Prospective basis means that the VBE has assumed financial 
responsibility for the cost of all items and services covered by the 
applicable payor prior to the provision of items and services to 
patients in the target patient population.
    (iii) Items and services means health care items, devices, supplies, 
and services.
    (iv) Manufacturer of a device or medical supply, target patient 
population, value-based activity, value-based arrangement, value-based 
enterprise, value-based purpose, and VBE participant shall have the 
meaning set forth in paragraph (ee) of this section.
    (hh) Arrangements for patient engagement and support to improve 
quality, health outcomes, and efficiency. As used in section 1128B of 
the Act, ``remuneration'' does not include a patient engagement tool or 
support furnished by a VBE participant to a patient in the target 
patient population of a value-based arrangement to which the VBE 
participant is a party if all of the conditions in paragraphs (hh)(1) 
through (9) of this section are met:
    (1) The VBE participant is not:
    (i) A pharmaceutical manufacturer, distributor, or wholesaler;
    (ii) A pharmacy benefit manager;
    (iii) A laboratory company;
    (iv) A pharmacy that primarily compounds drugs or primarily 
dispenses compounded drugs;
    (v) A manufacturer of a device or medical supply, unless the patient 
engagement tool or support is digital health technology;
    (vi) An entity or individual that sells or rents durable medical 
equipment, prosthetics, orthotics, or supplies covered by a Federal 
health care program (other than a pharmacy, a manufacturer of a device 
or medical supply, or a physician, provider, or other entity that 
primarily furnishes services);
    (vii) A medical device distributor or wholesaler that is not 
otherwise a manufacturer of a device or medical supply; or
    (viii) A manufacturer of a device or medical supply that was 
obligated under 42 CFR 403.906 to report one or more ownership or 
investment interests held by a physician or an immediate family member 
during the preceding calendar year, or that reasonably anticipates that 
it will be obligated to report one or more ownership or investment 
interests held by a physician or an immediate family member during the 
present calendar year, even if the patient engagement tool or support is 
digital health technology (for purposes of this paragraph, the terms 
``ownership or investment interest,'' ``physician,'' and ``immediate 
family member'' have the same meaning as set forth in 42 CFR 403.902).
    (2) The patient engagement tool or support is furnished directly to 
the patient (or the patient's caregiver, family member, or other 
individual acting on the patient's behalf) by a VBE participant that is 
a party to the value-based arrangement or its eligible agent.
    (3) The patient engagement tool or support:
    (i) Is an in-kind item, good, or service;

[[Page 1063]]

    (ii) That has a direct connection to the coordination and management 
of care of the target patient population;
    (iii) Does not include any cash or cash equivalent;
    (iv) Does not result in medically unnecessary or inappropriate items 
or services reimbursed in whole or in part by a Federal health care 
program;
    (v) Is recommended by the patient's licensed health care 
professional; and
    (vi) Advances one or more of the following goals:
    (A) Adherence to a treatment regimen determined by the patient's 
licensed health care professional.
    (B) Adherence to a drug regimen determined by the patient's licensed 
health care professional.
    (C) Adherence to a followup care plan established by the patient's 
licensed health care professional.
    (D) Prevention or management of a disease or condition as directed 
by the patient's licensed health care professional.
    (E) Ensure patient safety.
    (4) The patient engagement tool or support is not funded or 
contributed by:
    (i) A VBE participant that is not a party to the applicable value-
based arrangement; or
    (ii) An entity listed in paragraph (hh)(1) of this section.
    (5) The aggregate retail value of patient engagement tools and 
supports furnished to a patient by a VBE participant on an annual basis 
does not exceed $500. The monetary cap set forth in this paragraph 
(hh)(5) is adjusted each calendar year to the nearest whole dollar by 
the increase in the Consumer Price Index--Urban All Items (CPI-U) for 
the 12-month period ending the preceding September 30. OIG will publish 
guidance after September 30 of each year reflecting the increase in the 
CPI-U for the 12-month period ending September 30 and the new monetary 
cap applicable for the following calendar year.
    (6) The VBE participant or any eligible agent does not exchange or 
use the patient engagement tools or supports to market other 
reimbursable items or services or for patient recruitment purposes.
    (7) For a period of at least 6 years, the VBE participant makes 
available to the Secretary, upon request, all materials and records 
sufficient to establish that the patient engagement tool or support was 
distributed in a manner that meets the conditions of this paragraph 
(hh).
    (8) The availability of a tool or support is not determined in a 
manner that takes into account the type of insurance coverage of the 
patient.
    (9) For purposes of this paragraph (hh), the following definitions 
apply:
    (i) Eligible agent means any person or entity that is not identified 
in paragraphs (hh)(1)(i) through (viii) of this section as ineligible to 
furnish protected tools and supports under this paragraph.
    (ii) Coordination and management of care, target patient population, 
value-based arrangement, VBE, VBE participant, manufacturer of a device 
or medical supply, and digital health technology shall have the meaning 
set forth in paragraph (ee) of this section.
    (ii) CMS-sponsored model arrangements and CMS-sponsored model 
patient incentives.
    (1) As used in section 1128B of the Act, ``remuneration'' does not 
include an exchange of anything of value between or among CMS-sponsored 
model parties under a CMS-sponsored model arrangement for which CMS has 
determined that this safe harbor is available if all of the following 
conditions are met:
    (i) The CMS-sponsored model parties reasonably determine that the 
CMS-sponsored model arrangement will advance one or more goals of the 
CMS-sponsored model;
    (ii) The exchange of value does not induce CMS-sponsored model 
parties or other providers or suppliers to furnish medically unnecessary 
items or services, or reduce or limit medically necessary items or 
services furnished to any patient;
    (iii) The CMS-sponsored model parties do not offer, pay, solicit, or 
receive remuneration in return for, or to induce or reward, any Federal 
health care program referrals or other Federal health care program 
business generated outside of the CMS-sponsored model;

[[Page 1064]]

    (iv) The CMS-sponsored model parties in advance of or 
contemporaneous with the commencement of the CMS-sponsored model 
arrangement set forth the terms of the CMS-sponsored model arrangement 
in a signed writing. The writing must specify at a minimum the 
activities to be undertaken by the CMS-sponsored model parties and the 
nature of the remuneration to be exchanged under the CMS-sponsored model 
arrangement;
    (v) The parties to the CMS-sponsored model arrangement make 
available to the Secretary, upon request, all materials and records 
sufficient to establish whether the remuneration was exchanged in a 
manner that meets the conditions of this safe harbor; and
    (vi) The CMS-sponsored model parties satisfy such programmatic 
requirements as may be imposed by CMS in connection with the use of this 
safe harbor.
    (2) As used in section 1128B of the Act, ``remuneration'' does not 
include a CMS-sponsored model patient incentive for which CMS has 
determined that this safe harbor is available if all of the following 
conditions are met:
    (i) The CMS-sponsored model participant reasonably determines that 
the CMS-sponsored model patient incentive will advance one or more goals 
of the CMS-sponsored model;
    (ii) The CMS-sponsored model patient incentive has a direct 
connection to the patient's health care unless the participation 
documentation expressly specifies a different standard;
    (iii) The CMS-sponsored model patient incentive is furnished by a 
CMS-sponsored model participant (or by an agent of the CMS-sponsored 
model participant under the CMS-sponsored model participant's direction 
and control), unless otherwise specified by the participation 
documentation;
    (iv) The CMS-sponsored model participant makes available to the 
Secretary, upon request, all materials and records sufficient to 
establish whether the CMS-sponsored model patient incentive was 
distributed in a manner that meets the conditions of this safe harbor; 
and
    (v) The CMS-sponsored model patient incentive is furnished 
consistent with the CMS-sponsored model and satisfies such programmatic 
requirements as may be imposed by CMS in connection with the use of this 
safe harbor.
    (3) For purposes of this paragraph (ii), the following definitions 
apply:
    (i) CMS-sponsored model means:
    (A) A model being tested under section 1115A(b) of the Act or a 
model expanded under section 1115A(c) of the Act; or
    (B) The Medicare shared savings program under section 1899 of the 
Act.
    (ii) CMS-sponsored model arrangement means a financial arrangement 
between or among CMS-sponsored model parties to engage in activities 
under the CMS-sponsored model that is consistent with, and is not a type 
of arrangement prohibited by, the participation documentation.
    (iii) CMS-sponsored model participant means an individual or entity 
that is subject to and is operating under participation documentation 
with CMS to participate in a CMS-sponsored model.
    (iv) CMS-sponsored model party means:
    (A) A CMS-sponsored model participant; or
    (B) Another individual or entity whom the participation 
documentation specifies may enter into a CMS-sponsored model 
arrangement.
    (v) CMS-sponsored model patient incentive means remuneration not of 
a type prohibited by the participation documentation that is furnished 
to a patient under the terms of a CMS-sponsored model.
    (vi) Participation documentation means the participation agreement, 
legal instrument setting forth the terms and conditions of a grant or 
cooperative agreement, regulations, or model-specific addendum to an 
existing contract with CMS that specifies the terms of a CMS-sponsored 
model.
    (4) For purposes of remuneration that satisfies this paragraph (ii), 
the safe harbor protects:
    (i) For a CMS-sponsored model governed by participation 
documentation other than the legal instrument setting forth the terms 
and conditions of a grant or a cooperative agreement, the exchange of 
remuneration between CMS-sponsored model parties that occurs on or after 
the first day on which services under the CMS-sponsored model begin and 
no later than 6

[[Page 1065]]

months after the final payment determination made by CMS under the 
model;
    (ii) For a CMS-sponsored model governed by the legal instrument 
setting forth the terms and conditions of a grant or cooperative 
agreement, the exchange of remuneration between CMS-sponsored model 
parties that occurs on or after the first day of the period of 
performance (as defined at 45 CFR 75.2) or such other date specified in 
the participation documentation and no later than 6 months after 
closeout occurs pursuant to 45 CFR 75.381; and
    (iii) For a CMS-sponsored model patient incentive, an incentive 
given on or after the first day on which patient care services may be 
furnished under the CMS-sponsored model as specified by CMS in the 
participation documentation and no later than the last day on which 
patient care services may be furnished under the CMS-sponsored model, 
unless a different timeframe is established in the participation 
documentation. A patient may retain any incentives furnished in 
compliance with paragraph (ii)(2) of this section.
    (jj) Cybersecurity technology and related services. As used in 
section 1128B of the Act, ``remuneration'' does not include nonmonetary 
remuneration (consisting of cybersecurity technology and services) that 
is necessary and used predominantly to implement, maintain, or 
reestablish effective cybersecurity if all of the conditions in 
paragraphs (jj)(1) through (4) of this section are met.
    (1) The donor does not:
    (i) Directly take into account the volume or value of referrals or 
other business generated between the parties when determining the 
eligibility of a potential recipient for the technology or services, or 
the amount or nature of the technology or services to be donated; or
    (ii) Condition the donation of technology or services, or the amount 
or nature of the technology or services to be donated, on future 
referrals.
    (2) Neither the recipient nor the recipient's practice (or any 
affiliated individual or entity) makes the receipt of technology or 
services, or the amount or nature of the technology or services, a 
condition of doing business with the donor.
    (3) A general description of the technology and services being 
provided and the amount of the recipient's contribution, if any, are set 
forth in writing and signed by the parties.
    (4) The donor does not shift the costs of the technology or services 
to any Federal health care program.
    (5) For purposes of this paragraph (jj) the following definitions 
apply:
    (i) Cybersecurity means the process of protecting information by 
preventing, detecting, and responding to cyberattacks.
    (ii) Technology means any software or other types of information 
technology.
    (kk) ACO Beneficiary Incentive Program. As used in section 1128B of 
the Act, ``remuneration'' does not include an incentive payment made by 
an ACO to an assigned beneficiary under a beneficiary incentive program 
established under section 1899(m) of the Act, as amended by Congress 
from time to time, if the incentive payment is made in accordance with 
the requirements found in such subsection.

[57 FR 3330, Jan. 29, 1992, as amended at 57 FR 52729, Nov. 5, 1992; 61 
FR 2135, Jan. 25, 1996; 64 FR 63513, Nov. 19, 1999; 64 FR 63551, Nov. 
19, 1999; 64 FR 71317, Dec. 21, 1999; 66 FR 62989, Dec. 4, 2001; 66 FR 
63749, Dec. 10, 2001; 67 FR 11933, Mar. 18, 2002; 71 FR 45136, Aug. 8, 
2006; 72 FR 56644, Oct. 4, 2007; 78 FR 79219, Dec. 27, 2013; 81 FR 3012, 
Jan. 20, 2016; 81 FR 88407, Dec. 7, 2016; 85 FR 77887, Dec. 2, 2020]

    Effective Date Note: At 85 FR 76730, Nov. 30, 2020, Sec. 1001.952 
was amended. Portions were effective Jan. 29, 2021 and portions were 
effective Jan. 1, 2022. The amendments were corrected and a portion was 
delayed until Mar. 22, 2021, at 86 FR 7815, Feb. 2, 2021. The amendments 
were further corrected at 86 FR 7815, Feb. 2, 2021. Certain amendments 
and corrections were further delayed until Jan. 1, 2023, at 86 FR 10181, 
Feb. 19, 2021. Certain amendments and corrections were further delayed 
until Jan. 1, 2023, at 86 FR 15076, Mar. 22, 2021.



Sec. 1001.1001  Exclusion of entities owned or controlled by 
a sanctioned person.

    (a) Circumstance for exclusion. The OIG may exclude an entity:
    (1) If a person with a relationship with such entity--

[[Page 1066]]

    (i) Has been convicted of a criminal offense as described in 
sections 1128(a) and 1128(b)(1), (2), or (3) of the Act;
    (ii) Has had civil money penalties or assessments imposed under 
section 1128A of the Act; or
    (iii) Has been excluded from participation in Medicare or any State 
health care program, and
    (2) Such a person has a direct or indirect ownership or control 
interest in the entity, or formerly held an ownership or control 
interest in the entity but no longer holds an ownership or control 
interest because of a transfer of the interest to an immediate family 
member or a member of the person's household in anticipation of or 
following a conviction, imposition of a civil money penalty or 
assessment under section 1128A of the Act, or imposition of an 
exclusion.
    (b) Length of exclusion. (1) Except as provided in Sec. 
1001.3002(c), exclusions under this section will be for the same period 
as that of the individual whose relationship with the entity is the 
basis for this exclusion, if the individual has been or is being 
excluded.
    (2) If the individual was not excluded, the length of the entity's 
exclusion will be determined by considering the factors that would have 
been considered if the individual had been excluded.
    (3) An entity excluded under this section may apply for 
reinstatement at any time in accordance with the procedures set forth in 
Sec. 1001.3001(a)(2).

[57 FR 3330, Jan. 29, 1992, as amended at 64 FR 39427, July 22, 1999; 82 
FR 4114, Jan. 12, 2017]



Sec. 1001.1101  Failure to disclose certain information.

    (a) Circumstance for exclusion. The OIG may exclude any entity that 
did not fully and accurately, or completely, make disclosures as 
required by section 1124, 1124A or 1126 of the Act, and by part 455, 
subpart B and part 420, subpart C of this title.
    (b) Length of exclusion. The following factors will be considered in 
determining the length of an exclusion under this section--
    (1) The number of instances where full and accurate, or complete, 
disclosure was not made;
    (2) The significance of the undisclosed information;
    (3) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing (The lack of any prior 
record is to be considered neutral);
    (4) Any other facts that bear on the nature or seriousness of the 
conduct; and
    (5) The extent to which the entity knew that the disclosures made 
were not full or accurate.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46689, Sept. 2, 1998; 82 
FR 4115, Jan. 12, 2017]



Sec. 1001.1201  Failure to provide payment information.

    (a) Circumstance for exclusion. The OIG may exclude any individual 
or entity that furnishes, orders, refers for furnishing, or certifies 
the need for items or services for which payment may be made under 
Medicare or any of the State health care programs and that--
    (1) Fails to provide such information as is necessary to determine 
whether such payments are or were due and the amounts thereof, or
    (2) Has refused to permit such examination and duplication of its 
records as may be necessary to verify such information.
    (b) Length of exclusion. The following factors will be considered in 
determining the length of an exclusion under this section--
    (1) The number of instances where information was not provided;
    (2) The circumstances under which such information was not provided;
    (3) The amount of the payments at issue; and
    (4) Whether the individual or entity has a documented history of 
criminal, civil, or administrative wrongdoing. (The lack of any prior 
record is to be considered neutral).

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46689, Sept. 2, 1998; 82 
FR 4115, Jan. 12, 2017]

[[Page 1067]]



Sec. 1001.1301  Failure to grant immediate access.

    (a) Circumstance for exclusion. (1) The OIG may exclude any 
individual or entity that fails to grant immediate access upon 
reasonable request to--
    (i) The Secretary, a State survey agency or other authorized entity 
for the purpose of determining, in accordance with section 1864(a) of 
the Act, whether--
    (A) An institution is a hospital or skilled nursing facility;
    (B) An agency is a home health agency;
    (C) An agency is a hospice program;
    (D) A facility is a rural health clinic as defined in section 
1861(aa)(2) of the Act, or a comprehensive outpatient rehabilitation 
facility as defined in section 1861(cc)(2) of the Act;
    (E) A laboratory is meeting the requirements of section 1861(s) (15) 
and (16) of the Act, and section 353(f) of the Public Health Service 
Act;
    (F) A clinic, rehabilitation agency or public health agency is 
meeting the requirements of section 1861(p)(4) (A) or (B) of the Act;
    (G) An ambulatory surgical center is meeting the standards specified 
under section 1832(a)(2)(F)(i) of the Act;
    (H) A portable x-ray unit is meeting the requirements of section 
1861(s)(3) of the Act;
    (I) A screening mammography service is meeting the requirements of 
section 1834(c)(3) of the Act;
    (J) An end-stage renal disease facility is meeting the requirements 
of section 1881(b) of the Act;
    (K) A physical therapist in independent practice is meeting the 
requirements of section 1861(p) of the Act;
    (L) An occupational therapist in independent practice is meeting the 
requirements of section 1861(g) of the Act;
    (M) An organ procurement organization meets the requirements of 
section 1138(b) of the Act; or.
    (N) A rural primary care hospital meets the requirements of section 
1820(i)(2) of the Act;
    (ii) The Secretary, a State survey agency or other authorized entity 
to perform the reviews and surveys required under State plans in 
accordance with sections 1902(a)(26) (relating to inpatient mental 
hospital services), 1902(a)(31) (relating to intermediate care 
facilities for individuals with intellectual disabilities), 1919(g) 
(relating to nursing facilities), 1929(i) (relating to providers of home 
and community care and community care settings), 1902(a)(33) and 1903(g) 
of the Act;
    (iii) The OIG for reviewing records, documents, and other material 
or data in any medium (including electronically stored information and 
any tangible thing) necessary to the OIG's statutory functions; or
    (iv) A State Medicaid fraud control unit for the purpose of 
conducting its activities.
    (2) For purposes of paragraphs (a)(1)(i) and (a)(1)(ii) of this 
section, the term--
    Failure to grant immediate access means the failure to grant access 
at the time of a reasonable request or to provide a compelling reason 
why access may not be granted.
    Reasonable request means a written request made by a properly 
identified agent of the Secretary, of a State survey agency or of 
another authorized entity, during hours that the facility, agency or 
institution is open for business.
    The request will include a statement of the authority for the 
request, the rights of the entity in responding to the request, the 
definition of reasonable request and immediate access, and the penalties 
for failure to comply, including when the exclusion will take effect.
    (3) For purposes of paragraphs (a)(1)(iii) and (a)(1)(iv) of this 
section, the term--
    Failure to grant immediate access means--
    (i) The failure to produce or make available for inspection and 
copying the requested material upon reasonable request, or to provide a 
compelling reason why they cannot be produced, within 24 hours of such 
request, except when the OIG or State Medicaid Fraud Control Unit (MFCU) 
reasonably believes that the requested material is about to be altered 
or destroyed, or
    (ii) When the OIG or MFCU has reason to believe that the requested 
material is about to be altered or destroyed,

[[Page 1068]]

the failure to provide access to the requested material at the time the 
request is made.
    Reasonable request means a written request, signed by a designated 
representative of the OIG or MFCU and made by a properly identified 
agent of the OIG or an MFCU during reasonable business hours, where 
there is information to suggest that the person has violated statutory 
or regulatory requirements under Titles V, XI, XVIII, XIX, or XX of the 
Act. The request will include a statement of the authority for the 
request, the person's rights in responding to the request, the 
definition of ``reasonable request'' and ``failure to grant immediate 
access'' under part 1001, and the effective date, length, and scope and 
effect of the exclusion that would be imposed for failure to comply with 
the request, and the earliest date that a request for reinstatement 
would be considered.
    (4) Nothing in this section shall in any way limit access otherwise 
authorized under State or Federal law.
    (b) Length of exclusion. (1) An exclusion of an individual under 
this section may be for a period equal to the sum of:
    (i) The length of the period during which the immediate access was 
not granted, and
    (ii) An additional period of up to 90 days.
    (2) The exclusion of an entity may be for a longer period than the 
period in which immediate access was not granted based on consideration 
of the following factors--
    (i) The impact of the failure to grant the requested immediate 
access on Medicare or any of the State health care programs, 
beneficiaries or the public;
    (ii) The circumstances under which such access was refused;
    (iii) The impact of the exclusion on Medicare, Medicaid or any of 
the other Federal health care programs, beneficiaries or the public; and
    (iv) Whether the entity has a documented history of criminal, civil 
or administrative wrongdoing (The lack of any prior record is to be 
considered neutral).
    (3) For purposes of paragraphs (b)(1) and (b)(2) of this section, 
the length of the period in which immediate access was not granted will 
be measured from the time the request is made, or from the time by which 
access was required to be granted, whichever is later.
    (c) The exclusion will be effective as of the date immediate access 
was not granted.

[57 FR 3330, Jan. 29, 1992, as amended at 58 FR 40753, July 30, 1993; 63 
FR 46689, Sept. 2, 1998; 64 FR 39427, July 22, 1999; 82 FR 4115, Jan. 
12, 2017]



Sec. 1001.1401  Violations of PPS corrective action.

    (a) Circumstance for exclusion. The OIG may exclude any hospital 
that CMS determines has failed substantially to comply with a corrective 
action plan required by CMS under section 1886(f)(2)(B) of the Act.
    (b) Length of exclusion. The following factors will be considered in 
determining the length of exclusion under this section--
    (1) The impact of the hospital's failure to comply on Medicare, 
Medicaid or any of the other Federal health care programs, program 
beneficiaries or other individuals;
    (2) The circumstances under which the failure occurred;
    (3) The nature of the failure to comply;
    (4) The impact of the exclusion on Medicare, Medicaid or any of the 
other Federal health care programs, beneficiaries or the public; and
    (5) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing (The lack of any prior 
record is to be considered neutral).

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46689, Sept. 2, 1998; 64 
FR 39427, July 22, 1999]



Sec. 1001.1501  Default of health education loan or scholarship 
obligations.

    (a) Circumstance for exclusion. (1) Except as provided in paragraph 
(a)(4) of this section, the OIG may exclude any individual that the 
administrator of the health education loan, scholarship, or loan 
repayment program determines is in default on repayments of scholarship 
obligations or loans, or the obligations of any loan repayment program, 
in connection with health professions

[[Page 1069]]

education made or secured in whole or in part by the Secretary.
    (2) Before imposing an exclusion in accordance with paragraph (a)(1) 
of this section, the OIG must determine that the administrator of the 
health education loan, scholarship, or loan repayment program has taken 
all reasonable administrative steps to secure repayment of the loans or 
obligations. When an individual has been offered a Medicare offset 
arrangement as required by section 1892 of the Act, the OIG will find 
that all reasonable steps have been taken.
    (3) The OIG will take into account access of beneficiaries to 
physicians' services for which payment may be made under Medicare, 
Medicaid or other Federal health care programs in determining whether to 
impose an exclusion.
    (4) The OIG will not exclude a physician who is the sole community 
physician or the sole source of essential specialized services in a 
community if a State requests that the physician not be excluded.
    (b) Length of exclusion. The individual will be excluded until the 
administrator of the health education loan, scholarship, or loan 
repayment program notifies the OIG that the default has been cured or 
that there is no longer an outstanding debt. Upon such notice, the OIG 
will inform the individual of his or her right to apply for 
reinstatement.

[57 FR 3330, Jan. 29, 1992, as amended at 64 FR 39427, July 22, 1999; 67 
FR 11935, Mar. 18, 2002; 82 FR 4115, Jan. 12, 2017]



Sec. 1001.1551  Exclusion of individuals with ownership or control 
interest in sanctioned entities.

    (a) Circumstance for exclusion. The OIG may exclude any individual 
who--
    (1) Has a direct or indirect ownership or control interest in a 
sanctioned entity, and who knows or should know (as defined in section 
1128A(i)(6) of the Act) of the action constituting the basis for the 
conviction or exclusion set forth in paragraph (b) of this section; or
    (2) Is an officer or managing employee (as defined in section 
1126(b) of the Act) of such an entity.
    (b) For purposes of paragraph (a) of this section, the term 
``sanctioned entity'' means an entity that--
    (1) Has been convicted of any offense described in Sec. Sec. 
1001.101 through 1001.401 of this part; or
    (2) Has been terminated or excluded from participation in Medicare, 
Medicaid and all other Federal health care programs.
    (c) Length of exclusion. (1) If the entity has been excluded, the 
length of the individual's exclusion will be for the same period as that 
of the sanctioned entity.
    (2) If the entity was not excluded, the length of the individual's 
exclusion will be determined by considering the factors that would have 
been considered if the entity had been excluded.
    (3) An individual excluded under this section may apply for 
reinstatement in accordance with the procedures set forth in Sec. 
1001.3001.

[63 FR 46689, Sept. 2, 1998. Redesignated and amended at 82 FR 4115, 
Jan. 12, 2017]



Sec. 1001.1552  Making false statements or misrepresentation of
material facts.

    (a) Circumstance for exclusion. The OIG may exclude any individual 
or entity that it determines has knowingly made or caused to be made any 
false statement, omission, or misrepresentation of a material fact in 
any application, agreement, bid, or contract to participate or enroll as 
a provider of services or supplier under a Federal health care program, 
including Medicare Advantage organizations under Part C of Medicare, 
prescription drug plan sponsors under Part D of Medicare, Medicaid 
managed care organizations, and entities that apply to participate as 
providers of services or suppliers in such managed care organizations 
and such plans.
    (b) Definition of ``Material''. For purposes of this section, the 
term ``material'' means having a natural tendency to influence or be 
capable of influencing the decision to approve or deny the request to 
participate or enroll as a provider of services or supplier under a 
Federal health care program.
    (c) Sources. The OIG's determination under paragraph (a) of this 
section will be made on the basis of information from the following 
sources:

[[Page 1070]]

    (1) CMS;
    (2) Medicaid State agencies;
    (3) Fiscal agents or contractors or private insurance companies;
    (4) Law enforcement agencies;
    (5) State or local licensing or certification authorities;
    (6) State or local professional societies; or
    (7) Any other sources deemed appropriate by the OIG.
    (d) Length of exclusion. In determining the length of an exclusion 
imposed in accordance with this section, the OIG will consider the 
following factors:
    (1) The nature and circumstances surrounding the false statement;
    (2) Whether and to what extent payments were requested or received 
from the Federal health care program under the application, agreement, 
bid, or contract on which the false statement, omission, or 
misrepresentation was made; and
    (3) Whether the individual or entity has a documented history of 
criminal, civil, or administrative wrongdoing.

[82 FR 4115, Jan. 12, 2017]



Sec. 1001.1601  Violations of the limitations on physician charges.

    (a) Circumstance for exclusion. (1) The OIG may exclude a physician 
whom it determines--
    (i) Is a non-participating physician under section 1842(j) of the 
Act;
    (ii) Furnished services to a beneficiary;
    (iii) Knowingly and willfully billed--
    (A) On a repeated basis for such services actual charges in excess 
of the maximum allowable actual charge determined in accordance with 
section 1842(j)(1)(C) of the Act for the period January 1, 1987 through 
December 31, 1990, or
    (B) Individuals enrolled under part B of title XVIII of the Act 
during the statutory freeze for actual charges in excess of such 
physician's actual charges determined in accordance with section 
1842(j)(1)(A) of the Act for the period July 1, 1984 to December 31, 
1986; and''
    (iv) Is not the sole community physician or sole source of essential 
specialized services in the community.
    (2) The OIG will take into account access of beneficiaries to 
physicians' services for which Medicare payment may be made in 
determining whether to impose an exclusion.
    (b) Length of exclusion. (1) In determining the length of an 
exclusion in accordance with this section, the OIG will consider the 
following factors--
    (i) The number of services for which the physician billed in excess 
of the maximum allowable charges;
    (ii) The number of beneficiaries for whom services were billed in 
excess of the maximum allowable charges;
    (iii) The amount of the charges that were in excess of the maximum 
allowable charges; and
    (iv) Whether the physician has a documented history of criminal, 
civil, or administrative wrongdoing (the lack of any prior record is to 
be considered neutral).
    (2) The period of exclusion may not exceed 5 years.

[57 FR 3329, Jan. 29, 1992; 57 FR 9669, Mar. 20, 1992, as amended at 63 
FR 46689, Sept. 2, 1998; 82 FR 4116, Jan. 12, 2017]



Sec. 1001.1701  Billing for services of assistant at surgery during
cataract operations.

    (a) Circumstance for exclusion. The OIG may exclude a physician whom 
it determines--
    (1) Has knowingly and willfully presented or caused to be presented 
a claim, or billed an individual enrolled under Part B of the Medicare 
program (or his or her representative) for:
    (i) Services of an assistant at surgery during a cataract operation, 
or
    (ii) Charges that include a charge for an assistant at surgery 
during a cataract operation;
    (2) Has not obtained prior approval for the use of such assistant 
from the appropriate Utilization and Quality Control Quality Improvement 
Organization (QIO) or Medicare carrier; and
    (3) Is not the sole community physician or sole source of essential 
specialized services in the community.
    (b) The OIG will take into account access of beneficiaries to 
physicians' services for which Medicare payment may be made in 
determining whether to impose an exclusion.

[[Page 1071]]

    (c) Length of exclusion. (1) In determining the length of an 
exclusion in accordance with this section, the OIG will consider the 
following factors--
    (i) The number of instances for which claims were submitted or 
beneficiaries were billed for unapproved use of assistants during 
cataract operations;
    (ii) The amount of the claims or bills presented;
    (iii) The circumstances under which the claims or bills were made, 
including whether the services were medically necessary;
    (iv) Whether approval for the use of an assistant was requested from 
the QIO or carrier; and
    (v) Whether the physician has a documented history of criminal, 
civil, or administrative wrongdoing (the lack of any prior record is to 
be considered neutral).
    (2) The period of exclusion may not exceed 5 years.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46690, Sept. 2, 1998; 82 
FR 4116, Jan. 12, 2017]



                Sec. Appendix A to Subpart C of Part 1001

    The following is a sample written disclosure for purposes of 
satisfying the requirements of Sec. 1001.952(v)(3)(i)(B)(1)(i) of this 
part. This form is for illustrative purposes only; parties may, but are 
not required to, adapt this sample written disclosure form.

                 Notice of Ambulance Restocking Program

    Hospital X offers the following ambulance restocking program:
    1. We will restock all ambulance providers (other than ambulance 
providers that do not provide emergency services) that bring patients to 
Hospital X [or to a subpart of Hospital X, such as the emergency room] 
in the following category or categories: [insert description of category 
of ambulances to be restocked, i.e., all ambulance providers, all 
ambulance providers that do not charge patients or insurers for their 
services, or all nonprofit and Government ambulance providers]. 
[Optional: We only offer restocking of emergency transports.]
    2. The restocking will include the following drugs and medical 
supplies, and linens, used for patient prior to delivery of the patient 
to Hospital X: [insert description of drugs and medical supplies, and 
linens to be restocked].
    3. The ambulance providers [will/will not] be required to pay for 
the restocked drugs and medical supplies, and linens.
    4. The restocked drugs and medical supplies, and linens, must be 
documented as follows: [insert description consistent with the 
documentation requirements described in Sec. 1001.952(v). By way of 
example only, documentation may be by a patient care report filed with 
the receiving facility within 24 hours of delivery of the patient that 
records the name of the patient, the date of the transport, and the 
relevant drugs and medical supplies.]
    5. This restocking program does not apply to the restocking of 
ambulances that only provide non-emergency services or to the general 
stocking of an ambulance provider's inventory.
    6. To ensure that Hospital X does not bill any Federal health care 
program for restocked drugs or supplies for which a participating 
ambulance provider bills or is eligible to bill, all participating 
ambulance providers must notify Hospital X if they intend to submit 
claims for restocked drugs or supplies to any Federal health care 
program. Participating ambulance providers must agree to work with 
Hospital X to ensure that only one party bills for a particular 
restocked drug or supply.
    7. All participants in this ambulance restocking arrangement that 
bill Federal health care programs for restocked drugs or supplies must 
comply with all applicable Federal program billing and claims filing 
rules and regulations.
    8. For further information about our restocking program or to obtain 
a copy of this notice, please contact [name] at [telephone number].

Dated:____

/s/____
Appropriate officer or official

[66 FR 62991, Dec. 4, 2001]



                Subpart D_Waivers and Effect of Exclusion



Sec. 1001.1801  Waivers of exclusions.

    (a) The OIG has the authority to grant or deny a request from the 
administrator of a Federal health care program (as defined in section 
1128B(f) of the Act) that an exclusion from that program be waived with 
respect to an individual or entity, except that no waiver may be granted 
with respect to an exclusion under Sec. 1001.101(b). The request must 
be in writing and from an individual directly responsible for 
administering the Federal health care program.
    (b) With respect to exclusions under Sec. 1001.101(a), (c), or (d), 
a request from a Federal health care program for a

[[Page 1072]]

waiver of the exclusion will be considered only if the Federal health 
care program administrator determines that--
    (1) The individual or entity is the sole community physician or the 
sole source of essential specialized services in a community; and
    (2) The exclusion would impose a hardship on beneficiaries (as 
defined in section 1128A(i)(5) of the Act) of that program.
    (c) With respect to exclusions imposed under subpart C of this part, 
a request for waiver will only be granted if the OIG determines that 
imposition of the exclusion would not be in the public interest.
    (d) If the basis for the waiver ceases to exist, the waiver will be 
rescinded, and the individual or entity will be excluded for the period 
remaining on the exclusion, measured from the time the exclusion would 
have been imposed if the waiver had not been granted.
    (e) In the event a waiver is granted, it is applicable only to the 
program(s) for which waiver is requested.
    (f) The decision to grant, deny or rescind a request for a waiver is 
not subject to administrative or judicial review.

[57 FR 3330, Jan. 29, 1992, as amended at 82 FR 4116, Jan. 12, 2017]



Sec. 1001.1901  Scope and effect of exclusion.

    (a) Scope of exclusion. Exclusions of individuals and entities under 
this title will be from Medicare, Medicaid and any of the other Federal 
health care programs, as defined in Sec. 1001.2.
    (b) Effect of exclusion on excluded individuals and entities. (1) 
Unless and until an individual or entity is reinstated into the 
Medicare, Medicaid, and other Federal health care programs in accordance 
with subpart F of this part, no payment will be made by Medicare, 
including Medicare Advantage and Prescription Drug Plans, Medicaid, or 
any other Federal health care program for any item or service furnished, 
on or after the effective date specified in the notice--
    (i) By an excluded individual or entity; or
    (ii) At the medical direction or on the prescription of a physician 
or an authorized individual who is excluded when the person furnishing 
such item or service knew, or had reason to know, of the exclusion.
    (2) This section applies regardless of whether an individual or 
entity has obtained a program provider number or equivalent, either as 
an individual or as a member of a group, prior to being reinstated.
    (3) An excluded individual or entity may not take assignment of an 
enrollee's claim on or after the effective date of exclusion.
    (4) An excluded individual or entity that submits, or causes to be 
submitted, claims for items or services furnished during the exclusion 
period is subject to civil money penalty liability under section 
1128A(a)(1)(D) of the Act and criminal liability under section 
1128B(a)(3) of the Act and other provisions. In addition, submitting 
claims, or causing claims to be submitted or payments to be made, for 
items or services furnished, ordered, or prescribed, including 
administrative and management services or salary, may serve as the basis 
for denying reinstatement to the programs.
    (c) Exceptions to paragraph (b)(1) of this section. (1) If an 
enrollee of Part B of Medicare submits an otherwise payable claim for 
items or services furnished by an excluded individual or entity, or 
under the medical direction or on the prescription of an excluded 
physician or other authorized individual after the effective date of 
exclusion, CMS will pay the first claim submitted by the enrollee and 
immediately notify the enrollee of the exclusion.
    (2) CMS will not pay an enrollee for items or services furnished by 
an excluded individual or entity, or under the medical direction or on 
the prescription of an excluded physician or other authorized individual 
more than 15 days after the date on the notice to the enrollee, or after 
the effective date of the exclusion, whichever is later.
    (3) Unless the Secretary determines that the health and safety of 
beneficiaries receiving services under Medicare, Medicaid or any of the 
other Federal health care programs warrants the exclusion taking effect 
earlier, payment may be made under such program

[[Page 1073]]

for up to 30 days after the effective date of the exclusion for--
    (i) Inpatient institutional services furnished to an individual who 
was admitted to an excluded institution before the date of the 
exclusion,
    (ii) Home health services and hospice care furnished to an 
individual under a plan of care established before the effective date of 
the exclusion, and
    (iii) Any health care items that are ordered by a practitioner, 
provider or supplier from an excluded manufacturer before the effective 
date of the exclusion and delivered within 30 days of the effective date 
of such exclusion. (For the period October 2, 1998, to October 4, 1999, 
payment may be made under Medicare or a State health care program for up 
to 60 days after the effective date of the exclusion for any health care 
items that are ordered by a practitioner, provider or supplier from an 
excluded manufacturer before the effective date of such exclusion and 
delivered within 60 days of the effect of the exclusion.)
    (4) CMS will not pay any claims submitted by, or for items or 
services ordered or prescribed by, an excluded provider for dates of 
service 15 days or more after the notice of the provider's exclusion was 
mailed to the supplier.
    (5)(i) Notwithstanding the other provisions of this section, payment 
may be made under Medicare, Medicaid or other Federal health care 
programs for certain emergency items or services furnished by an 
excluded individual or entity, or at the medical direction or on the 
prescription of an excluded physician or other authorized individual 
during the period of exclusion. To be payable, a claim for such 
emergency items or services must be accompanied by a sworn statement of 
the person furnishing the items or services specifying the nature of the 
emergency and why the items or services could not have been furnished by 
an individual or entity eligible to furnish or order such items or 
services.
    (ii) Notwithstanding paragraph (c)(5)(i) of this section, no claim 
for emergency items or services will be payable if such items or 
services were provided by an excluded individual who, through an 
employment, contractual or any other arrangement, routinely provides 
emergency health care items or services.

[57 FR 3330, Jan. 29, 1992, as amended at 60 FR 32917, June 26, 1995; 63 
FR 46690, Sept. 2, 1998; 64 FR 39427, July 22, 1999; 82 FR 4116, Jan. 
12, 2017]



                      Subpart E_Notice and Appeals



Sec. 1001.2001  Notice of intent to exclude.

    (a) Except as provided in paragraph (c) of this section, if the OIG 
proposes to exclude an individual or entity in accordance with subpart C 
of this part, or in accordance with subpart B of this part where the 
exclusion is for a period exceeding 5 years, it will send written notice 
of its intent, the basis for the proposed exclusion and the potential 
effect of an exclusion. Within 30 days of receipt of notice, which will 
be deemed to be 5 days after the date on the notice, the individual or 
entity may submit documentary evidence and written argument concerning 
whether the exclusion is warranted and any related issues.
    (b) If the OIG intends to exclude an individual or entity under the 
provisions of Sec. 1001.701, Sec. 1001.801, or Sec. 1001.1552, in 
conjunction with the submission of documentary evidence and written 
argument, an individual or entity may request an opportunity to present 
oral argument to an OIG official.
    (c) Exception. If the OIG intends to exclude an individual or entity 
under the provisions of Sec. 1001.901, Sec. 1001.951, Sec. 1001.1301, 
Sec. 1001.1401, Sec. 1001.1601, or Sec. 1001.1701, paragraph (a) of 
this section will not apply.
    (d) If an entity has a provider agreement under section 1866 of the 
Act, and the OIG proposes to terminate that agreement in accordance with 
section 1866(b)(2)(C) of the Act, the notice provided for in paragraph 
(a) of this section will so state.

[63 FR 46690, Sept. 2, 1998, as amended at 63 FR 57918, Oct. 29, 1998; 
82 FR 4116, Jan. 12, 2017]



Sec. 1001.2002  Notice of exclusion.

    (a) Except as provided in Sec. 1001.2003, if the OIG determines 
that exclusion is warranted, it will send a written notice

[[Page 1074]]

of this decision to the affected individual or entity.
    (b) The exclusion will be effective 20 days from the date of the 
notice.
    (c) The written notice will state--
    (1) The basis for the exclusion;
    (2) The length of the exclusion and, where applicable, the factors 
considered in setting the length;
    (3) The effect of the exclusion;
    (4) The earliest date on which the OIG will consider a request for 
reinstatement;
    (5) The requirements and procedures for reinstatement; and
    (6) The appeal rights available to the excluded individual or 
entity.
    (d) Paragraph (b) of this section does not apply to exclusions 
imposed in accordance with Sec. 1001.1301.
    (e) No later than 15 days prior to the final exhibit exchanges 
required under Sec. 1005.8 of this chapter, the OIG may amend its 
notice letter if information comes to light that justifies the 
imposition of a different period of exclusion other than the one 
proposed in the original notice letter.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46690, Sept. 2, 1998]



Sec. 1001.2003  Notice of proposal to exclude.

    (a) Except as provided in paragraph (c) of this section, if the OIG 
proposes to exclude an individual or entity in accordance with Sec. 
1001.901, Sec. 1001.951, Sec. 1001.1601, or Sec. 1001.1701, it will 
send a written notice of proposal to exclude to the affected individual 
or entity. The written notice will provide the same information set 
forth in Sec. 1001.2002(c). If an entity has a provider agreement under 
section 1866 of the Act, and the OIG also proposes to terminate that 
agreement in accordance with section 1866(b)(2)(C) of the Act, the 
notice will so indicate. The exclusion will be effective 60 days after 
the receipt of the notice (as defined in Sec. 1005.2 of this chapter) 
unless, within that period, the individual or entity files a written 
request for a hearing in accordance with part 1005 of this chapter. Such 
request must set forth--
    (1) The specific issues or statements in the notice with which the 
individual or entity disagrees;
    (2) The basis for that disagreement;
    (3) The defenses on which reliance is intended;
    (4) Any reasons why the proposed length of exclusion should be 
modified; and
    (5) Reasons why the health or safety of individuals receiving 
services under Medicare or any of the State health care programs does 
not warrant the exclusion going into effect prior to the completion of 
an administrative law judge (ALJ) proceeding in accordance with part 
1005 of this chapter.
    (b) If the individual or entity makes a timely written request for a 
hearing and the OIG has determined that the health or safety of 
individuals receiving services under Medicare or any of the State health 
care programs does not warrant immediate exclusion, an exclusion will 
only go into effect as of the date of the ALJ's decision, if the ALJ 
upholds the decision to exclude.
    (c) If, prior to issuing a notice of proposal to exclude under 
paragraph (a) of this section, the OIG determines that the health or 
safety of individuals receiving services under Medicare or any of the 
State health care programs warrants the exclusion taking place prior to 
the completion of an ALJ proceeding in accordance with part 1005 of this 
chapter, the OIG will proceed under Sec. Sec. 1001.2001 and 1001.2002.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46690, Sept. 2, 1998; 65 
FR 24414, Apr. 26, 2000; 82 FR 4116, Jan. 12, 2017]



Sec. 1001.2004  Notice to State agencies.

    HHS will promptly notify each appropriate State agency administering 
or supervising the administration of each State health care program of:
    (a) The facts and circumstances of each exclusion, and
    (b) The period for which the State agency is being directed to 
exclude the individual or entity.



Sec. 1001.2005  Notice to State licensing agencies.

    (a) HHS will promptly notify the appropriate State(s) or local 
agencies or authorities having responsibility for the licensing or 
certification of an individual or entity excluded (or directed to be 
excluded) from participation of the facts and circumstances of the 
exclusion.

[[Page 1075]]

    (b) HHS will request that appropriate investigations be made and 
sanctions invoked in accordance with applicable State law and policy, 
and will request that the State or local agency or authority keep the 
Secretary and the OIG fully and currently informed with respect to any 
actions taken in response to the request.



Sec. 1001.2006  Notice to others regarding exclusion.

    (a) HHS will give notice of the exclusion and the effective date to 
the public, to beneficiaries (in accordance with Sec. 1001.1901(c)), 
and, as appropriate, to--
    (1) Any entity in which the excluded individual is known to be 
serving as an employee, administrator, operator, or in which the 
individual is serving in any other capacity and is receiving payment for 
providing services (The lack of this notice will not affect CMS's 
ability to deny payment for services);
    (2) State Medicaid Fraud Control Units;
    (3) Utilization and Quality Control Quality Improvement 
Organizations;
    (4) Hospitals, skilled nursing facilities, home health agencies and 
health maintenance organizations;
    (5) Medical societies and other professional organizations;
    (6) Contractors, health care prepayment plans, private insurance 
companies and other affected agencies and organizations;
    (7) The State and Area Agencies on Aging established under title III 
of the Older Americans Act;
    (8) The National Practitioner Data Bank.
    (9) Other Departmental operating divisions, Federal agencies, and 
other agencies or organizations, as appropriate.
    (b) In the case of an exclusion under Sec. 1001.101 of this 
chapter, if section 304(a)(5) of the Controlled Substances Act (21 
U.S.C. 824(a)(5)) applies, HHS will give notice to the Attorney General 
of the United States of the facts and circumstances of the exclusion and 
the length of the exclusion.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46690, Sept. 2, 1998]



Sec. 1001.2007  Appeal of exclusions.

    (a)(1) Except as provided in Sec. 1001.2003, an individual or 
entity excluded under this part may file a request for a hearing before 
an ALJ only on the issues of whether:
    (i) The basis for the imposition of the sanction exists, and
    (ii) The length of exclusion is unreasonable.
    (2) When the OIG imposes an exclusion under subpart B of this part 
for a period of 5 years, paragraph (a)(1)(ii) of this section will not 
apply.
    (3) The request for a hearing should contain the information set 
forth in Sec. 1005.2(d) of this chapter.
    (b) The excluded individual or entity has 60 days from the receipt 
of notice of exclusion provided for in Sec. 1001.2002 to file a request 
for such a hearing.
    (c) The standard of proof at a hearing is preponderance of the 
evidence.
    (d) When the exclusion is based on the existence of a criminal 
conviction or a civil judgment imposing liability by Federal, State or 
local court, a determination by another Government agency, or any other 
prior determination where the facts were adjudicated and a final 
decision was made, the basis for the underlying conviction, civil 
judgment or determination is not reviewable and the individual or entity 
may not collaterally attack it either on substantive or procedural 
grounds in this appeal.
    (e) The procedures in part 1005 of this chapter will apply to the 
appeal.

[57 FR 3330, Jan. 29, 1992, as amended at 67 FR 11935, Mar. 18, 2002]



                Subpart F_Reinstatement into the Programs



Sec. 1001.3001  Timing and method of request for reinstatement.

    (a)(1) Except as provided in paragraph (a)(2) of this section or in 
Sec. 1001.501(b)(2), Sec. 1001.501(c), or Sec. 1001.601(b)(4), an 
excluded individual or entity (other than those excluded in accordance 
with Sec. Sec. 1001.1001 and 1001.1501) may submit a written request 
for reinstatement to the OIG only after the date specified in the notice 
of exclusion. Obtaining a program provider

[[Page 1076]]

number or equivalent does not reinstate eligibility.
    (2) An entity excluded under Sec. 1001.1001 may apply for 
reinstatement prior to the date specified in the notice of exclusion by 
submitting a written request for reinstatement that includes 
documentation demonstrating that the standards set forth in Sec. 
1001.3002(c) have been met.
    (b) Upon receipt of a written request, the OIG will require the 
requestor to furnish specific information and authorization to obtain 
information from private health insurers, peer review bodies, probation 
officers, professional associates, investigative agencies and such 
others as may be necessary to determine whether reinstatement should be 
granted.
    (c) Failure to furnish the required information or authorization 
will result in the continuation of the exclusion.
    (d) If a period of exclusion is reduced on appeal (regardless of 
whether further appeal is pending), the individual or entity may request 
reinstatement once the reduced exclusion period expires.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46691, Sept. 2, 1998; 82 
FR 4117, Jan. 12, 2017]



Sec. 1001.3002  Basis for reinstatement.

    (a) The OIG will authorize reinstatement if it determines that--
    (1) The period of exclusion has expired;
    (2) There are reasonable assurances that the types of actions that 
formed the basis for the original exclusion have not recurred and will 
not recur; and
    (3) There is no additional basis under sections 1128(a) or (b) or 
1128A of the Act for continuation of the exclusion.
    (b) In making the reinstatement determination described in paragraph 
(a) of this section, the OIG will consider--
    (1) Conduct of the individual or entity occurring prior to the date 
of the notice of exclusion, if not known to the OIG at the time of the 
exclusion;
    (2) Conduct of the individual or entity after the date of the notice 
of exclusion;
    (3) Whether all fines and all debts due and owing (including 
overpayments) to any Federal, State, or local government that relate to 
Medicare, Medicaid, and all other Federal health care programs have been 
paid or satisfactory arrangements have been made to fulfill obligations;
    (4) Whether CMS has determined that the individual or entity 
complies with, or has made satisfactory arrangements to fulfill, all the 
applicable conditions of participation or supplier conditions for 
coverage under the statutes and regulations;
    (5) Whether the individual or entity has, during the period of 
exclusion, submitted claims, or caused claims to be submitted or payment 
to be made by any Federal health care program, for items or services the 
excluded party furnished, ordered, or prescribed, including health care 
administrative services. This section applies regardless of whether an 
individual or entity has obtained a program provider number or 
equivalent, either as an individual or as a member of a group, prior to 
being reinstated; and
    (c) If the OIG determines that the criteria in paragraphs (a)(2) and 
(3) of this section have been met, an entity excluded in accordance with 
Sec. 1001.1001 will be reinstated upon a determination by the OIG that 
the individual whose conviction, exclusion, or civil money penalty was 
the basis for the entity's exclusion--
    (1) Has properly reduced his or her ownership or control interest in 
the entity below 5 percent;
    (2) Is no longer an officer, director, agent or managing employee of 
the entity; or
    (3) Has been reinstated in accordance with paragraph (a) of this 
section or Sec. 1001.3005.
    (d) Reinstatement will not be effective until the OIG grants the 
request and provides notice under Sec. 1001.3003(a) of this part. 
Reinstatement will be effective as provided in the notice.
    (e) A determination with respect to reinstatement is not appealable 
or reviewable except as provided in Sec. 1001.3004.
    (f) An ALJ may not require reinstatement of an individual or entity 
in accordance with this chapter.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46691, Sept. 2, 1998; 64 
FR 39427, July 22, 1999; 82 FR 4117, Jan. 12, 2017]

[[Page 1077]]



Sec. 1001.3003  Approval of request for reinstatement.

    (a) If the OIG grants a request for reinstatement, the OIG will--
    (1) Give written notice to the excluded individual or entity 
specifying the date of reinstatement;
    (2) Notify CMS of the date of the individual's or entity's 
reinstatement;
    (3) Notify appropriate Federal and State agencies that administer 
health care programs that the individual or entity has been reinstated 
into all Federal health care programs; and
    (4) To the extent applicable, give notice to others that were 
originally notified of the exclusion.
    (b) A determination by the OIG to reinstate an individual or entity 
has no effect if a Federal health care program has imposed a longer 
period of exclusion under its own authorities.

[64 FR 39428, July 22, 1999]



Sec. 1001.3004  Denial of request for reinstatement.

    (a) If a request for reinstatement is denied, OIG will give written 
notice to the requesting individual or entity. Within 30 days of the 
date on the notice, the excluded individual or entity may submit:
    (1) Documentary evidence and written argument against the continued 
exclusion,
    (2) A written request to present written evidence and oral argument 
to an OIG official, or
    (3) Both documentary evidence and a written request.
    (b) After evaluating any additional evidence submitted by the 
excluded individual or entity (or at the end of the 30-day period, if 
none is submitted), the OIG will send written notice either confirming 
the denial, and indicating that a subsequent request for reinstatement 
will not be considered until at least one year after the date of denial, 
or approving the request consistent with the procedures set forth in 
Sec. 1001.3003(a).
    (c) The decision to deny reinstatement will not be subject to 
administrative or judicial review.



Sec. 1001.3005  Withdrawal of exclusion for reversed or vacated 
decisions.

    (a) An exclusion will be withdrawn and an individual or entity will 
be reinstated into Medicare, Medicaid, and other Federal health care 
programs retroactive to the effective date of the exclusion when such 
exclusion is based on--
    (1) A conviction that is reversed or vacated on appeal;
    (2) An action by another agency, such as a State agency or licensing 
board, that is reversed or vacated on appeal; or
    (3) An OIG exclusion action that is reversed or vacated at any stage 
of an individual's or entity's administrative appeal process.
    (b) If an individual or entity is reinstated in accordance with 
paragraph (a) of this section, CMS and other Federal health care 
programs will make payment for services covered under such program that 
were furnished or performed during the period of exclusion.
    (c) The OIG will give notice of a reinstatement under this section 
in accordance with Sec. 1001.3003(a).
    (d) An action taken by the OIG under this section will not require 
any other Federal health care program to reinstate the individual or 
entity if such program has imposed an exclusion under its own authority.
    (e) If an action which results in the retroactive reinstatement of 
an individual or entity is subsequently overturned, the OIG may reimpose 
the exclusion for the initial period of time, less the period of time 
that was served prior to the reinstatement of the individual or entity.

[57 FR 3330, Jan. 29, 1992, as amended at 64 FR 39428, July 22, 1999; 67 
FR 11935, Mar. 18, 2002; 82 FR 4117, Jan. 12, 2017]



PART 1002_PROGRAM INTEGRITY_STATE-INITIATED EXCLUSIONS FROM MEDICAID--
Table of Contents



                      Subpart A_General Provisions

Sec.
1002.1 Basis and scope.
1002.2 Other applicable regulations.
1002.3 General authority.

[[Page 1078]]

1002.4 Disclosure by providers and State Medicaid agencies.
1002.5 State plan requirement.
1002.6 Payment prohibitions.

       Subpart B_State Exclusion of Certain Managed Care Entities

1002.203 State exclusion of certain managed care entities.

           Subpart C_Procedures for State-Initiated Exclusions

1002.210 General authority.
1002.211 [Reserved]
1002.212 State agency notifications.
1002.213 Appeals of exclusions.
1002.214 Basis for reinstatement after State agency-initiated exclusion.
1002.215 Action on request for reinstatement.

 Subpart D_Notification to OIG of State or Local Convictions of Crimes 
                            Against Medicaid

1002.230 Notification of State or local convictions of crimes against 
          Medicaid.

    Authority: 42 U.S.C. 1302, 1320a-3, 1320a-5, 1320a-7, 1396(a)(4)(A), 
1396a(p), 1396a(a)(39), 1396a(a)(41), and 1396b(i)(2).

    Source: 57 FR 3343, Jan. 29, 1992, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1002.1  Basis and scope.

    (a) Statutory basis. This part implements sections 1902(a)(4), 
1902(a)(39), 1902(a)(41), 1902(p), 1903(i)(2), 1124, 1126, and 1128 of 
the Act.
    (1) Under authority of section 1902(a)(4) of the Act, this part sets 
forth methods of administration and procedures the State agency must 
follow to exclude a provider from participation in the State Medicaid 
program. State-initiated exclusion from Medicaid may lead to OIG 
exclusion from all Federal health care programs.
    (2) Under authority of sections 1124 and 1126 of the Act, this part 
requires the Medicaid agency to obtain and disclose to the OIG certain 
provider ownership and control information, along with actions taken on 
a provider's application to participate in the program.
    (3) Under authority of sections 1902(a)(41) and 1128 of the Act, 
this part requires the State agency to notify the OIG of sanctions and 
other actions the State takes to limit a provider's participation in 
Medicaid.
    (4) Section 1902(p) of the Act permits the State to exclude an 
individual or entity from Medicaid for any reason the Secretary can 
exclude and requires the State to exclude certain managed care entities 
that could be excluded by the OIG.
    (5) Sections 1902(a)(39) and 1903(i)(2) of the Act prohibit State 
payments to providers and deny Federal financial participation (FFP) in 
State expenditures for items or services furnished by an individual or 
entity that has been excluded by the OIG from participation in Federal 
health care programs.
    (b) Scope. This part specifies certain bases upon which the State 
may or, in some cases, must exclude an individual or entity from 
participation in the Medicaid program and the administrative procedures 
the State must follow to do so. These regulations specifically address 
the authority of State agencies to exclude on their own initiative, 
regardless of whether the OIG has excluded an individual or entity under 
part 1001 of this chapter. In addition, this part delineates the States' 
obligation to obtain certain information from Medicaid providers and to 
inform the OIG of information received and actions taken.

[82 FR 4117, Jan. 12, 2017]



Sec. 1002.2  Other applicable regulations.

    (a) Part 455, subpart B, of this title sets forth requirements for 
disclosure of ownership and control information to the State Medicaid 
agency by providers and fiscal agents.
    (b) Part 438, subpart J, of this title sets forth payment and 
exclusion requirements specific to Medicaid managed care organizations.

[82 FR 4118, Jan. 12, 2017]



Sec. 1002.3  General authority.

    (a) In addition to any other authority it may have, a State may 
exclude an individual or entity from participation in the Medicaid 
program for any reason for which the Secretary could exclude that 
individual or entity from participation in Federal health care programs 
under sections 1128, 1128A, or 1866(b)(2) of the Act.

[[Page 1079]]

    (b) Nothing contained in this part should be construed to limit a 
State's own authority to exclude an individual or entity from Medicaid 
for any reason or period authorized by State law.

[57 FR 3343, Jan. 29, 1992, as amended at 64 FR 39428, July 22, 1999. 
Redesignated and amended at 82 FR 4118, Jan. 12, 2017]



Sec. 1002.4  Disclosure by providers and State Medicaid agencies.

    (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 described in Sec. 
1001.1001(a)(1) of this chapter.
    (b) Notification to Inspector General. (1) The Medicaid agency must 
notify the Inspector General 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 promptly notify the Inspector General of any 
action it takes on the provider's application for participation in the 
program.
    (3) The agency must also promptly notify the Inspector General of 
any action it takes to limit the ability of an individual or entity to 
participate in its program, regardless of what such an action is called. 
This includes, but is not limited to, suspension actions, settlement 
agreements and situations where an individual or entity voluntarily 
withdraws from the program to avoid a formal sanction.
    (c) Denial or termination of provider participation. (1) The 
Medicaid agency may refuse to enter into or renew an agreement with a 
provider if any person who has an ownership or control interest, or who 
is an agent or managing employee of the provider, in the provider has 
been convicted of a criminal offense related to that person's 
involvement in any program established under Medicare, Medicaid, Title 
V, Title XX, or Title XXI of the Act.
    (2) The Medicaid agency may refuse to enter into, or 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.

[57 FR 3343, Jan. 29, 1992, as amended at 63 FR 46691, Sept. 2, 1998. 
Redesignated and amended at 82 FR 4118, Jan. 12, 2017]



Sec. 1002.5  State plan requirement.

    The plan must provide that the requirements of this subpart are met. 
However, the provisions of these regulations are minimum requirements. 
The agency may impose broader sanctions if it has the authority to do so 
under State law.

[57 FR 3343, Jan. 29, 1992. Redesignated at 82 FR 4118, Jan. 12, 2017]



Sec. 1002.6  Payment prohibitions.

    (a) Denial of payment by State agencies. Except as provided for in 
Sec. 1001.1901(c)(3), (4) and (5)(i) of this chapter, no payment may be 
made by the State agency for any item or service furnished on or after 
the effective date specified in the notice:
    (1) By an individual or entity excluded by the OIG or
    (2) At the medical direction or on the prescription of a physician 
or other authorized individual who is excluded by the OIG when a person 
furnishing such item or service knew, or had reason to know, of the 
exclusion.
    (b) Denial of Federal financial participation (FFP). FFP is not 
available for any item or service for which the State agency is required 
to deny payment under paragraph (a) of this section. FFP will be 
available for items and services furnished after the excluded individual 
or entity is reinstated in the Medicaid program.

[82 FR 4118, Jan. 12, 2017]



       Subpart B_State Exclusion of Certain Managed Care Entities



Sec. 1002.203  State exclusion of certain managed care entities.

    (a) The State agency, in order to receive FFP, must provide that it 
will exclude from participation any managed care organization (as 
defined in section 1903(m) of the Act) or entity furnishing services 
under a waiver approved under section 1915(b)(1) of the Act, if such 
organization or entity--

[[Page 1080]]

    (1) Has a prohibited ownership or control relationship with any 
individual or entity that could subject the managed care organization or 
entity to exclusion under Sec. 1001.1001 or Sec. 1001.1551 of this 
chapter or
    (2) Has, directly or indirectly, a substantial contractual 
relationship with an individual or entity that could be excluded under 
Sec. 1001.1001 or Sec. 1001.1551 of this chapter.
    (b) As used in this section, the term--
    Exclude includes the refusal to enter into or renew a participation 
agreement or the termination of such an agreement.
    Substantial contractual relationship is one in which the sanctioned 
individual described in Sec. 1001.1001 of this chapter has direct or 
indirect business transactions with the organization or entity that, in 
any fiscal year, amount to more than $25,000 or 5 percent of the 
organization's or entity's total operating expenses, whichever is less. 
Business transactions include, but are not limited to, contracts, 
agreements, purchase orders, or leases to obtain services, supplies, 
equipment, space or salaried employment.

[57 FR 3343, Jan. 29, 1992, as amended at 63 FR 46691, Sept. 2, 1998; 82 
FR 4118, Jan. 12, 2017]



           Subpart C_Procedures for State-Initiated Exclusions



Sec. 1002.210  General authority.

    The State agency must have administrative procedures in place that 
enable it to exclude an individual or entity for any reason for which 
the Secretary could exclude such individual or entity under parts 1001 
or 1003 of this chapter. The period of such exclusion is at the 
discretion of the State agency.



Sec. 1002.211  [Reserved]



Sec. 1002.212  State agency notifications.

    When the State agency initiates an exclusion under Sec. 1002.210, 
it must provide to the individual or entity subject to the exclusion 
notification consistent with that required in subpart E of part 1001 of 
this chapter, and must notify other State agencies, the State medical 
licensing board (where applicable), the public, beneficiaries, and 
others as provided in Sec. Sec. 1001.2005 and 1001.2006 of this 
chapter.



Sec. 1002.213  Appeals of exclusions.

    Before imposing an exclusion under Sec. 1002.210, the State agency 
must give the individual or entity the opportunity to submit documents 
and written argument against the exclusion. The individual or entity 
must also be given any additional appeals rights that would otherwise be 
available under procedures established by the State.



Sec. 1002.214  Basis for reinstatement after State agency-initiated 
exclusion.

    (a) The provisions of this section and Sec. 1002.215 apply to the 
reinstatement in the Medicaid program of all individuals or entities 
excluded in accordance with Sec. 1002.210, if a State affords 
reinstatement opportunity to those excluded parties.
    (b) An individual or entity who has been excluded from Medicaid may 
be reinstated only by the Medicaid agency that imposed the exclusion.
    (c) An individual or entity may submit to the State agency a request 
for reinstatement at any time after the date specified in the notice of 
exclusion.



Sec. 1002.215  Action on request for reinstatement.

    (a) The State agency may grant reinstatement only if it is 
reasonably certain that the types of actions that formed the basis for 
the original exclusion have not recurred and will not recur. In making 
this determination, the agency will consider, in addition to any factors 
set forth in State law--
    (1) The conduct of the individual or entity occurring prior to the 
date of the notice of exclusion, if not known to the agency at the time 
of the exclusion;
    (2) The conduct of the individual or entity after the date of the 
notice of exclusion; and
    (3) Whether all fines, and all debts due and owing (including 
overpayments) to any Federal, State or local government that relate to 
Medicare or any of the State health care programs,

[[Page 1081]]

have been paid, or satisfactory arrangements have been made, that 
fulfill these obligations.
    (b) Notice of action on request for reinstatement. (1) If the State 
agency approves the request for reinstatement, it must give written 
notice to the excluded party, and to all others who were informed of the 
exclusion in accordance with Sec. 1002.212, specifying the date on 
which Medicaid program participation may resume.
    (2) If the State agency does not approve the request for 
reinstatement, it will notify the excluded party of its decision. Any 
appeal of a denial of reinstatement will be in accordance with State 
procedures and need not be subject to administrative or judicial review, 
unless required by State law.



 Subpart D_Notification to OIG of State or Local Convictions of Crimes 
                            Against Medicaid



Sec. 1002.230  Notification of State or local convictions of crimes 
against Medicaid.

    (a) The State agency must notify the OIG whenever a State or local 
court has convicted an individual who is receiving reimbursement under 
Medicaid of a criminal offense related to participation in the delivery 
of health care items or services under the Medicaid program, except 
where the State Medicaid Fraud Control Unit (MFCU) has so notified the 
OIG.
    (b) If the State agency was involved in the investigation or 
prosecution of the case, it must send notice within 15 days after the 
conviction.
    (c) If the State agency was not so involved, it must give notice 
within 15 days after it learns of the conviction.



PART 1003_CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS--
Table of Contents



                      Subpart A_General Provisions

Sec.
1003.100 Basis and purpose.
1003.110 Definitions.
1003.120 Liability for penalties and assessments.
1003.130 Assessments.
1003.140 Determinations regarding the amount of penalties and 
          assessments and the period of exclusion.
1003.150 Delegation of authority.
1003.160 Waiver of exclusion.

  Subpart B_CMPs, Assessments, and Exclusions for False or Fraudulent 
                   Claims and Other Similar Misconduct

1003.200 Basis for civil money penalties, assessments, and exclusions.
1003.210 Amount of penalties and assessments.
1003.220 Determinations regarding the amount of penalties and 
          assessments and the period of exclusion.

   Subpart C_CMPs, Assessments, and Exclusions for Anti-Kickback and 
                   Physician Self-Referral Violations

1003.300 Basis for civil money penalties, assessments, and exclusions.
1003.310 Amount of penalties and assessments.
1003.320 Determinations regarding the amount of penalties and 
          assessments and the period of exclusion.

 Subpart D_CMPs and Assessments for Contracting Organization Misconduct

1003.400 Basis for civil money penalties and assessments.
1003.410 Amount of penalties and assessments for Contracting 
          Organizations.
1003.420 Determinations regarding the amount of penalties and 
          assessments.

           Subpart E_CMPs and Exclusions for EMTALA Violations

1003.500 Basis for civil money penalties and exclusions.
1003.510 Amount of penalties.
1003.520 Determinations regarding the amount of penalties and the period 
          of exclusion.

               Subpart F_CMPs for Section 1140 Violations

1003.600 Basis for civil money penalties.
1003.610 Amount of penalties.
1003.620 Determinations regarding the amount of penalties.

Subpart G [Reserved]

  Subpart H_CMPs for Adverse Action Reporting and Disclosure Violations

1003.800 Basis for civil money penalties.
1003.810 Amount of penalties.
1003.820 Determinations regarding the amount of penalties.

[[Page 1082]]

           Subpart I_CMPs for Select Agent Program Violations

1003.900 Basis for civil money penalties.
1003.910 Amount of penalties.
1003.920 Determinations regarding the amount of penalties.

 Subpart J_CMPs, Assessments, and Exclusions for Beneficiary Inducement 
                               Violations

1003.1000 Basis for civil money penalties, assessments, and exclusions.
1003.1010 Amount of penalties and assessments.
1003.1020 Determinations regarding the amount of penalties and 
          assessments and the period of exclusion.

      Subpart K_CMPs for the Sale of Medicare Supplemental Policies

1003.1100 Basis for civil money penalties.
1003.1110 Amount of penalties.
1003.1120 Determinations regarding the amount of penalties.

                 Subpart L_CMPs for Drug Price Reporting

1003.1200 Basis for civil money penalties.
1003.1210 Amount of penalties.
1003.1220 Determinations regarding the amount of penalties.

    Subpart M_CMPs for Notifying a Skilled Nursing Facility, Nursing 
   Facility, Home Health Agency, or Community Care Setting of a Survey

1003.1300 Basis for civil money penalties.
1003.1310 Amount of penalties.
1003.1320 Determinations regarding the amount of penalties.

Subpart N [Reserved]

   Subpart O_Procedures for the Imposition of CMPs, Assessments, and 
                               Exclusions

1003.1500 Notice of proposed determination.
1003.1510 Failure to request a hearing.
1003.1520 Collateral estoppel.
1003.1530 Settlement.
1003.1540 Judicial review.
1003.1550 Collection of penalties and assessments.
1003.1560 Notice to other agencies.
1003.1570 Limitations.
1003.1580 Statistical sampling.
1003.1590 Effect of exclusion.
1003.1600 Reinstatement.

    Authority: 42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10, 
1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 1395dd(d)(1), 1395mm, 
1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).

    Source: 51 FR 34777, Sept. 30, 1986, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1003.100  Basis and purpose.

    (a) Basis. This part implements sections 1128(c), 1128A, 1140, 
1819(b)(3)(B), 1819(g)(2)(A), 1857(g)(2)(A), 1860D-12(b)(3)(E), 1860D-
31(i)(3), 1862(b)(3)(C), 1867(d)(1), 1876(i)(6), 1877(g), 1882(d), 
1891(c)(1); 1903(m)(5), 1919(b)(3)(B), 1919(g)(2)(A), 1927(b)(3)(B), 
1927(b)(3)(C), and 1929(i)(3) of the Social Security Act; sections 
421(c) and 427(b)(2) of Public Law 99-660; and section 201(i) of Public 
Law 107-188 (42 U.S.C. 1320a-7(c), 1320a-7a, 1320b-10, 1395i-3(b)(3)(B), 
1395i-3(g)(2)(A), 1395w-27(g)(2)(A), 1395w-112(b)(3)(E), 1395w-
141(i)(3), 1395y(b)(3)(B), 1395dd(d)(1), 1395mm(i)(6), 1395nn(g), 
1395ss(d), 1395bbb(c)(1), 1396b(m)(5), 1396r(b)(3)(B), 1396r(g)(2)(A), 
1396r-8(b)(3)(B), 1396r-8(b)(3)(C), 1396t(i)(3), 11131(c), 11137(b)(2), 
and 262a(i)).
    (b) Purpose. This part--
    (1) Provides for the imposition of civil money penalties and, as 
applicable, assessments and exclusions against persons who have 
committed an act or omission that violates one or more provisions of 
this part and
    (2) Sets forth the appeal rights of persons subject to a penalty, 
assessment, and exclusion.

[81 FR 88354, Dec. 7, 2016]



Sec. 1003.110  Definitions.

    For purposes of this part:
    Assessment means the amounts described in this part and includes the 
plural of that term.
    Claim means an application for payment for an item or service under 
a Federal health care program.
    Contracting organization means a public or private entity, including 
a health maintenance organization, Medicare Advantage organization, 
Prescription Drug Plan sponsor, or other organization that has 
contracted with the Department or a State to furnish, or otherwise pay 
for, items and services to Medicare or Medicaid beneficiaries pursuant 
to sections 1857, 1860D-12, 1876(b), or 1903(m) of the Act.
    Enrollee means an individual who is eligible for Medicare or 
Medicaid and

[[Page 1083]]

who enters into an agreement to receive services from a contracting 
organization.
    Items and services or items or services includes without limitation, 
any item, device, drug, biological, supply, or service (including 
management or administrative services), including, but not limited to, 
those that are listed in an itemized claim for program payment or a 
request for payment; for which payment is included in any Federal or 
State health care program reimbursement method, such as a prospective 
payment system or managed care system; or that are, in the case of a 
claim based on costs, required to be entered in a cost report, books of 
account, or other documents supporting the claim (whether or not 
actually entered).
    Knowingly means that a person, with respect to an act, has actual 
knowledge of the act, acts in deliberate ignorance of the act, or acts 
in reckless disregard of the act, and no proof of specific intent to 
defraud is required.
    Material means having a natural tendency to influence, or be capable 
of influencing, the payment or receipt of money or property.
    Maternal and Child Health Services Block Grant program means the 
program authorized under Title V of the Act.
    Medical malpractice claim or action means a written complaint or 
claim demanding payment based on a physician's, dentist's, or other 
health care practitioner's provision of, or failure to provide, health 
care services and includes the filing of a cause of action based on the 
law of tort brought in any State or Federal court or other adjudicative 
body.
    Non-separately-billable item or service means an item or service 
that is a component of, or otherwise contributes to the provision of, an 
item or a service, but is not itself a separately billable item or 
service.
    Overpayment means any funds that a person receives or retains under 
Medicare or Medicaid to which the person, after applicable 
reconciliation, is not entitled under such program.
    Participating hospital means either a hospital or a critical access 
hospital, as defined in section 1861(mm)(1) of the Act, that has entered 
into a Medicare provider agreement under section 1866 of the Act.
    Penalty means the amount described in this part and includes the 
plural of that term.
    Person means an individual, trust or estate, partnership, 
corporation, professional association or corporation, or other entity, 
public or private.
    Physician incentive plan means any compensation arrangement between 
a contracting organization and a physician or physician group that may 
directly or indirectly have the effect of reducing or limiting services 
provided with respect to enrollees in the organization.
    Preventive care, for purposes of the definition of the term 
Remuneration as set forth in this section and the preventive care 
exception to section 231(h) of HIPAA, means any service that--
    (1) Is a prenatal service or a post-natal well-baby visit or is a 
specific clinical service described in the current U.S. Preventive 
Services Task Force's Guide to Clinical Preventive Services, and
    (2) Is reimbursable in whole or in part by Medicare or an applicable 
State health care program.
    Reasonable request, with respect to Sec. 1003.200(b)(10), means a 
written request, signed by a designated representative of the OIG and 
made by a properly identified agent of the OIG during reasonable 
business hours. The request will include: A statement of the authority 
for the request, the person's rights in responding to the request, the 
definition of ``reasonable request'' and ``failure to grant timely 
access'' under part 1003, the deadline by which the OIG requests access, 
and the amount of the civil money penalty or assessment that could be 
imposed and the effective date, length, and scope and effect of the 
exclusion that would be imposed for failure to comply with the request, 
and the earliest date that a request for reinstatement would be 
considered.
    Remuneration, for the purposes of Sec. 1003.1000(a) of this part, 
is consistent with the definition in section 1128A(i)(6) of the Act and 
includes the waiver of copayment, coinsurance and deductible amounts (or 
any part thereof) and transfers of items or services

[[Page 1084]]

for free or for other than fair market value. The term ``remuneration'' 
does not include:
    (1) The waiver of coinsurance and deductible amounts by a person, if 
the waiver is not offered as part of any advertisement or solicitation; 
the person does not routinely waive coinsurance or deductible amounts; 
and the person waives coinsurance and deductible amounts after 
determining in good faith that the individual is in financial need or 
failure by the person to collect coinsurance or deductible amounts after 
making reasonable collection efforts;
    (2) Any permissible practice as specified in section 1128B(b)(3) of 
the Act or in regulations issued by the Secretary;
    (3) Differentials in coinsurance and deductible amounts as part of a 
benefit plan design (as long as the differentials have been disclosed in 
writing to all beneficiaries, third party payers and providers), to whom 
claims are presented;
    (4) Incentives given to individuals to promote the delivery of 
preventive care services where the delivery of such services is not tied 
(directly or indirectly) to the provision of other services reimbursed 
in whole or in part by Medicare or an applicable State health care 
program. Such incentives may include the provision of preventive care, 
but may not include--
    (i) Cash or instruments convertible to cash; or
    (ii) An incentive the value of which is disproportionally large in 
relationship to the value of the preventive care service (i.e., either 
the value of the service itself or the future health care costs 
reasonably expected to be avoided as a result of the preventive care).
    (5) A reduction in the copayment amount for covered OPD services 
under section 1833(t)(8)(B) of the Act;
    (6) Items or services that improve a beneficiary's ability to obtain 
items and services payable by Medicare or Medicaid, and pose a low risk 
of harm to Medicare and Medicaid beneficiaries and the Medicare and 
Medicaid programs by--
    (i) Being unlikely to interfere with, or skew, clinical decision 
making;
    (ii) Being unlikely to increase costs to Federal health care 
programs or beneficiaries through overutilization or inappropriate 
utilization; and
    (iii) Not raising patient safety or quality-of-care concerns;
    (7) The offer or transfer of items or services for free or less than 
fair market value by a person if--
    (i) The items or services consist of coupons, rebates, or other 
rewards from a retailer;
    (ii) The items or services are offered or transferred on equal terms 
available to the general public, regardless of health insurance status; 
and
    (iii) The offer or transfer of the items or services is not tied to 
the provision of other items or services reimbursed in whole or in part 
by the program under Title XVIII or a State health care program (as 
defined in section 1128(h) of the Act);
    (8) The offer or transfer of items or services for free or less than 
fair market value by a person, if--
    (i) The items or services are not offered as part of any 
advertisement or solicitation;
    (ii) The offer or transfer of the items or services is not tied to 
the provision of other items or services reimbursed in whole or in part 
by the program under Title XVIII or a State health care program (as 
defined in section 1128(h) of the Act);
    (iii) There is a reasonable connection between the items or services 
and the medical care of the individual; and
    (iv) The person provides the items or services after determining in 
good faith that the individual is in financial need;
    (9) Waivers by a Part D Plan sponsor (as that term is defined in 42 
CFR 423.4) of any copayment for the first fill of a covered Part D drug 
(as defined in section 1860D-2(e)) that is a generic drug (as defined in 
42 CFR 423.4) or an authorized generic drug (as defined in 21 CFR 314.3) 
for individuals enrolled in the Part D plan (as that term is defined in 
42 CFR 423.4), as long as such waivers are included in the benefit 
design package submitted to CMS. This exception is applicable to 
coverage years beginning on or after January 1, 2018.
    (10) The provision of telehealth technologies by a provider of 
services, physician, or a renal dialysis facility (as such terms are 
defined for purposes of

[[Page 1085]]

title XVIII of the Act) to an individual with end-stage renal disease 
who is receiving home dialysis for which payment is being made under 
part B of such title, if:
    (i) The telehealth technologies are furnished to the individual by 
the provider of services, physician, or the renal dialysis facility that 
is currently providing the in-home dialysis, telehealth services, or 
other end-stage renal disease care to the individual, or has been 
selected or contacted by the individual to schedule an appointment or 
provide services;
    (ii) The telehealth technologies are not offered as part of any 
advertisement or solicitation; and
    (iii) The telehealth technologies are provided for the purpose of 
furnishing telehealth services related to the individual's end-stage 
renal disease.
    Request for payment means an application submitted by a person to 
any person for payment for an item or service.
    Respondent means the person upon whom the Department has imposed, or 
proposes to impose, a penalty, assessment or exclusion.
    Responsible Official means the individual designated pursuant to 42 
CFR part 73 to serve as the Responsible Official for the person holding 
a certificate of registration to possess, use, or transfer select agents 
or toxins.
    Responsible physician means a physician who is responsible for the 
examination, treatment, or transfer of an individual who comes to a 
participating hospital's emergency department requesting examination or 
treatment, including any physician who is on-call for the care of such 
individual and fails or refuses to appear within a reasonable time at 
such hospital to provide services relating to the examination, 
treatment, or transfer of such individual. Responsible physician also 
includes a physician who is responsible for the examination or treatment 
of individuals at hospitals with specialized capabilities or facilities, 
as provided under section 1867(g) of the Act, including any physician 
who is on-call for the care of such individuals and refuses to accept an 
appropriate transfer or fails or refuses to appear within a reasonable 
time to provide services related to the examination or treatment of such 
individuals.
    Select agents and toxins is defined consistent with the definition 
of ``select agent and/or toxin'' and ``overlap select agent and/or 
toxin'' as set forth in 42 CFR part 73.
    Separately billable item or service means an item or service for 
which an identifiable payment may be made under a Federal health care 
program, e.g., an itemized claim or a payment under a prospective 
payment system or other reimbursement methodology.
    Should know, or should have known, means that a person, with respect 
to information, either acts in deliberate ignorance of the truth or 
falsity of the information or acts in reckless disregard of the truth or 
falsity of the information. For purposes of this definition, no proof of 
specific intent to defraud is required.
    Social Services Block Grant Program means the program authorized 
under Title XX of the Act.
    Telehealth technologies, for purposes of paragraph (10) of the 
definition of the term ``remuneration'' as set forth in this section, 
means hardware, software, and services that support distant or remote 
communication between the patient and provider, physician, or renal 
dialysis facility for diagnosis, intervention, or ongoing care 
management.
    Timely basis means, in accordance with Sec. 1003.300(a) of this 
part, the 60-day period from the time the prohibited amounts are 
collected by the individual or the entity.

[51 FR 34777, Sept. 30, 1986, as amended at 56 FR 28492, June 21, 1991; 
57 FR 3345, Jan. 29, 1992; 59 FR 32124, June 22, 1994; 59 FR 36086, July 
15, 1994; 60 FR 16584, Mar. 31, 1995; 61 FR 13449, Mar. 27, 1996; 65 FR 
24415, Apr. 26, 2000; 65 FR 35584, June 5, 2000; 66 FR 39452, July 31, 
2001; 67 FR 11935, Mar. 18, 2002; 67 FR 76905, Dec. 13, 2002; 69 FR 
28845, May 19, 2004. Redesignated and amended at 81 FR 88355, 88409, 
Dec. 7, 2016; 85 FR 77894, Dec. 2, 2020]



Sec. 1003.120  Liability for penalties and assessments.

    (a) In any case in which it is determined that more than one person 
was responsible for a violation described in this part, each such person 
may be held liable for the penalty prescribed by this part.

[[Page 1086]]

    (b) In any case in which it is determined that more than one person 
was responsible for a violation described in this part, an assessment 
may be imposed, when authorized, against any one such person or jointly 
and severally against two or more such persons, but the aggregate amount 
of the assessments collected may not exceed the amount that could be 
assessed if only one person was responsible.
    (c) Under this part, a principal is liable for penalties and 
assessments for the actions of his or her agent acting within the scope 
of his or her agency. This provision does not limit the underlying 
liability of the agent.

[81 FR 88356, Dec. 7, 2016]



Sec. 1003.130  Assessments.

    The assessment in this part is in lieu of damages sustained by the 
Department or a State agency because of the violation.

[81 FR 88356, Dec. 7, 2016]



Sec. 1003.140  Determinations regarding the amount of penalties 
and assessments and the period of exclusion.

    (a) Except as otherwise provided in this part, in determining the 
amount of any penalty or assessment or the period of exclusion in 
accordance with this part, the OIG will consider the following factors--
    (1) The nature and circumstances of the violation;
    (2) The degree of culpability of the person against whom a civil 
money penalty, assessment, or exclusion is proposed. It should be 
considered an aggravating circumstance if the respondent had actual 
knowledge where a lower level of knowledge was required to establish 
liability (e.g., for a provision that establishes liability if the 
respondent ``knew or should have known'' a claim was false or 
fraudulent, it will be an aggravating circumstance if the respondent 
knew the claim was false or fraudulent). It should be a mitigating 
circumstance if the person took appropriate and timely corrective action 
in response to the violation. For purposes of this part, corrective 
action must include disclosing the violation to the OIG through the 
Self-Disclosure Protocol and fully cooperating with the OIG's review and 
resolution of such disclosure, or in cases of physician self-referral 
law violations, disclosing the violation to CMS through the Self-
Referral Disclosure Protocol;
    (3) The history of prior offenses. Aggravating circumstances 
include, if at any time prior to the violation, the individual--or in 
the case of an entity, the entity itself; any individual who had a 
direct or indirect ownership or control interest (as defined in section 
1124(a)(3) of the Act) in a sanctioned entity at the time the violation 
occurred and who knew, or should have known, of the violation; or any 
individual who was an officer or a managing employee (as defined in 
section 1126(b) of the Act) of such an entity at the time the violation 
occurred--was held liable for criminal, civil, or administrative 
sanctions in connection with a program covered by this part or in 
connection with the delivery of a health care item or service;
    (4) Other wrongful conduct. Aggravating circumstances include proof 
that the individual--or in the case of an entity, the entity itself; any 
individual who had a direct or indirect ownership or control interest 
(as defined in section 1124(a)(3) of the Act) in a sanctioned entity at 
the time the violation occurred and who knew, or should have known, of 
the violation; or any individual who was an officer or a managing 
employee (as defined in section 1126(b) of the Act) of such an entity at 
the time the violation occurred--engaged in wrongful conduct, other than 
the specific conduct upon which liability is based, relating to a 
government program or in connection with the delivery of a health care 
item or service. The statute of limitations governing civil money 
penalty proceedings does not apply to proof of other wrongful conduct as 
an aggravating circumstance; and
    (5) Such other matters as justice may require. Other circumstances 
of an aggravating or mitigating nature should be considered if, in the 
interests of justice, they require either a reduction or an increase in 
the penalty, assessment, or period of exclusion to achieve the purposes 
of this part.

[[Page 1087]]

    (b)(1) After determining the amount of any penalty and assessment in 
accordance with this part, the OIG considers the ability of the person 
to pay the proposed civil money penalty or assessment. The person shall 
provide, in a time and manner requested by the OIG, sufficient financial 
documentation, including, but not limited to, audited financial 
statements, tax returns, and financial disclosure statements, deemed 
necessary by the OIG to determine the person's ability to pay the 
penalty or assessment.
    (2) If the person requests a hearing in accordance with 42 CFR 
1005.2, the only financial documentation subject to review is that which 
the person provided to the OIG during the administrative process, unless 
the ALJ finds that extraordinary circumstances prevented the person from 
providing the financial documentation to the OIG in the time and manner 
requested by the OIG prior to the hearing request.
    (c) In determining the amount of any penalty and assessment to be 
imposed under this part the following circumstances are also to be 
considered--
    (1) If there are substantial or several mitigating circumstances, 
the aggregate amount of the penalty and assessment should be set at an 
amount sufficiently below the maximum permitted by this part to reflect 
that fact.
    (2) If there are substantial or several aggravating circumstances, 
the aggregate amount of the penalty and assessment should be set at an 
amount sufficiently close to or at the maximum permitted by this part to 
reflect that fact.
    (3) Unless there are extraordinary mitigating circumstances, the 
aggregate amount of the penalty and assessment should not be less than 
double the approximate amount of damages and costs (as defined by 
paragraph (e)(2) of this section) sustained by the United States, or any 
State, as a result of the violation.
    (4) The presence of any single aggravating circumstance may justify 
imposing a penalty and assessment at or close to the maximum even when 
one or more mitigating factors is present.
    (d)(1) The standards set forth in this section are binding, except 
to the extent that their application would result in imposition of an 
amount that would exceed limits imposed by the United States 
Constitution.
    (2) The amount imposed will not be less than the approximate amount 
required to fully compensate the United States, or any State, for its 
damages and costs, tangible and intangible, including, but not limited 
to, the costs attributable to the investigation, prosecution, and 
administrative review of the case.
    (3) Nothing in this part limits the authority of the Department or 
the OIG to settle any issue or case as provided by Sec. 1003.1530 or to 
compromise any exclusion and any penalty and assessment as provided by 
Sec. 1003.1550.
    (4) Penalties, assessments, and exclusions imposed under this part 
are in addition to any other penalties, assessments, or other sanctions 
prescribed by law.

[81 FR 88356, Dec. 7, 2016]



Sec. 1003.150  Delegation of authority.

    The OIG is delegated authority from the Secretary to impose civil 
money penalties and, as applicable, assessments and exclusions against 
any person who has violated one or more provisions of this part. The 
delegation of authority includes all powers to impose and compromise 
civil monetary penalties, assessments, and exclusion under section 1128A 
of the Act.

[81 FR 88356, Dec. 7, 2016]



Sec. 1003.160  Waiver of exclusion.

    (a) The OIG will consider a request from the administrator of a 
Federal health care program for a waiver of an exclusion imposed under 
this part as set forth in paragraph (b) of this section. The request 
must be in writing and from an individual directly responsible for 
administering the Federal health care program.
    (b) If the OIG subsequently obtains information that the basis for a 
waiver no longer exists, the waiver will cease and the person will be 
fully excluded from the Federal health care programs for the remainder 
of the exclusion period, measured from the time the full exclusion would 
have been imposed if the waiver had not been granted.

[[Page 1088]]

    (c) The OIG will notify the administrator of the Federal health care 
program whether his or her request for a waiver has been granted or 
denied.
    (d) If a waiver is granted, it applies only to the program(s) for 
which waiver is requested.
    (e) The decision to grant, deny, or rescind a waiver is not subject 
to administrative or judicial review.

[81 FR 88356, Dec. 7, 2016]



  Subpart B_CMPs, Assessments, and Exclusions for False or Fraudulent 
                   Claims and Other Similar Misconduct

    Source: 81 FR 88357, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.200  Basis for civil money penalties, assessments,
and exclusions.

    (a) The OIG may impose a penalty, assessment, and an exclusion 
against any person who it determines has knowingly presented, or caused 
to be presented, a claim that was for--
    (1) An item or service that the person knew, or should have known, 
was not provided as claimed, including a claim that was part of a 
pattern or practice of claims based on codes that the person knew, or 
should have known, would result in greater payment to the person than 
the code applicable to the item or service actually provided;
    (2) An item or service for which the person knew, or should have 
known, that the claim was false or fraudulent;
    (3) An item or service furnished during a period in which the person 
was excluded from participation in the Federal health care program to 
which the claim was presented;
    (4) A physician's services (or an item or service) for which the 
person knew, or should have known, that the individual who furnished (or 
supervised the furnishing of) the service--
    (i) Was not licensed as a physician;
    (ii) Was licensed as a physician, but such license had been obtained 
through a misrepresentation of material fact (including cheating on an 
examination required for licensing); or
    (iii) Represented to the patient at the time the service was 
furnished that the physician was certified by a medical specialty board 
when he or she was not so certified; or
    (5) An item or service that a person knew, or should have known was 
not medically necessary, and which is part of a pattern of such claims.
    (b) The OIG may impose a penalty; an exclusion; and, where 
authorized, an assessment against any person who it determines--
    (1) Has knowingly presented, or caused to be presented, a request 
for payment in violation of the terms of--
    (i) An agreement to accept payments on the basis of an assignment 
under section 1842(b)(3)(B)(ii) of the Act;
    (ii) An agreement with a State agency or other requirement of a 
State Medicaid plan not to charge a person for an item or service in 
excess of the amount permitted to be charged;
    (iii) An agreement to be a participating physician or supplier under 
section 1842(h)(1) of the Act; or
    (iv) An agreement in accordance with section 1866(a)(1)(G) of the 
Act not to charge any person for inpatient hospital services for which 
payment had been denied or reduced under section 1886(f)(2) of the Act;
    (2) Has knowingly given, or caused to be given, to any person, in 
the case of inpatient hospital services subject to section 1886 of the 
Act, information that he or she knew, or should have known, was false or 
misleading and that could reasonably have been expected to influence the 
decision when to discharge such person or another person from the 
hospital;
    (3) Is an individual who is excluded from participating in a Federal 
health care program under section 1128 or 1128A of the Act, and who--
    (i) Knows, or should know, of the action constituting the basis for 
the exclusion and retains a direct or indirect ownership or control 
interest of 5 percent or more in an entity that participates in a 
Federal health care program or
    (ii) Is an officer or a managing employee (as defined in section 
1126(b) of the Act) of such entity;
    (4) Arranges or contracts (by employment or otherwise) with an 
individual or entity that the person knows, or should know, is excluded 
from participation in Federal health care programs

[[Page 1089]]

for the provision of items or services for which payment may be made 
under such a program;
    (5) Has knowingly and willfully presented, or caused to be 
presented, a bill or request for payment for items and services 
furnished to a hospital patient for which payment may be made under a 
Federal health care program if that bill or request is inconsistent with 
an arrangement under section 1866(a)(1)(H) of the Act or violates the 
requirements for such an arrangement;
    (6) Orders or prescribes a medical or other item or service during a 
period in which the person was excluded from a Federal health care 
program, in the case when the person knows, or should know, that a claim 
for such medical or other item or service will be made under such a 
program;
    (7) Knowingly makes, or causes to be made, any false statement, 
omission, or misrepresentation of a material fact in any application, 
bid, or contract to participate or enroll as a provider of services or a 
supplier under a Federal health care program, including contracting 
organizations, and entities that apply to participate as providers of 
services or suppliers in such contracting organizations;
    (8) Knows of an overpayment and does not report and return the 
overpayment in accordance with section 1128J(d) of the Act;
    (9) Knowingly makes, uses, or causes to be made or used, a false 
record or statement material to a false or fraudulent claim for payment 
for items and services furnished under a Federal health care program; or
    (10) Fails to grant timely access to records, documents, and other 
material or data in any medium (including electronically stored 
information and any tangible thing), upon reasonable request, to the 
OIG, for the purpose of audits, investigations, evaluations, or other 
OIG statutory functions. Such failure to grant timely access means:
    (i) Except when the OIG reasonably believes that the requested 
material is about to be altered or destroyed, the failure to produce or 
make available for inspection and copying the requested material upon 
reasonable request or to provide a compelling reason why they cannot be 
produced, by the deadline specified in the OIG's written request, and
    (ii) When the OIG has reason to believe that the requested material 
is about to be altered or destroyed, the failure to provide access to 
the requested material at the time the request is made.
    (c) The OIG may impose a penalty against any person who it 
determines, in accordance with this part, is a physician and who 
executes a document falsely by certifying that a Medicare beneficiary 
requires home health services when the physician knows that the 
beneficiary does not meet the eligibility requirements in section 
1814(a)(2)(C) or 1835(a)(2)(A) of the Act.
    (d) The OIG may impose a penalty against any person who it 
determines knowingly certifies, or causes another individual to certify, 
a material and false statement in a resident assessment pursuant to 
sections 1819(b)(3)(B) and 1919(b)(3)(B).



Sec. 1003.210  Amount of penalties and assessments.

    (a) Penalties.\1\ (1) Except as provided in this section, the OIG 
may impose a penalty of not more than $10,000 for each individual 
violation that is subject to a determination under this subpart.
---------------------------------------------------------------------------

    \1\ The penalty amounts in this section are updated annually, as 
adjusted in accordance with the Federal Civil Monetary Penalty Inflation 
Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal 
Civil Penalties Inflation Adjustment Act Improvements Act of 2015 
(section 701 of Pub. L. 114-74). Annually adjusted amounts are published 
at 45 CFR part 102.
---------------------------------------------------------------------------

    (2) The OIG may impose a penalty of not more than $15,000 for each 
person with respect to whom a determination was made that false or 
misleading information was given under Sec. 1003.200(b)(2).
    (3) The OIG may impose a penalty of not more than $10,000 per day 
for each day that the prohibited relationship described in Sec. 
1003.200(b)(3) occurs.
    (4) For each individual violation of Sec. 1003.200(b)(4), the OIG 
may impose a penalty of not more than $10,000 for

[[Page 1090]]

each separately billable or non-separately-billable item or service 
provided, furnished, ordered, or prescribed by an excluded individual or 
entity.
    (5) The OIG may impose a penalty of not more than $2,000 for each 
bill or request for payment for items and services furnished to a 
hospital patient in violation of Sec. 1003.200(b)(5).
    (6) The OIG may impose a penalty of not more than $50,000 for each 
false statement, omission, or misrepresentation of a material fact in 
violation of Sec. 1003.200(b)(7).
    (7) The OIG may impose a penalty of not more than $50,000 for each 
false record or statement in violation of Sec. 1003.200(b)(9).
    (8) The OIG may impose a penalty of not more than $10,000 for each 
item or service related to an overpayment that is not reported and 
returned in accordance with section 1128J(d) of the Act in violation of 
Sec. 1003.200(b)(8).
    (9) The OIG may impose a penalty of not more than $15,000 for each 
day of failure to grant timely access in violation of Sec. 
1003.200(b)(10).
    (10) For each false certification in violation of Sec. 1003.200(c), 
the OIG may impose a penalty of not more than the greater of--
    (i) $5,000; or
    (ii) Three times the amount of Medicare payments for home health 
services that are made with regard to the false certification of 
eligibility by a physician, as prohibited by section 1814(a)(2)(C) or 
1835(a)(2)(A) of the Act.
    (11) For each false certification in violation of Sec. 1003.200(d), 
the OIG may impose a penalty of not more than--
    (i) $1,000 with respect to an individual who willfully and knowingly 
falsely certifies a material and false statement in a resident 
assessment; and
    (ii) $5,000 with respect to an individual who willfully and 
knowingly causes another individual to falsely certify a material and 
false statement in a resident assessment.
    (b) Assessments. (1) Except for violations of Sec. 1003.200(b)(4), 
(5), and (7), and Sec. 1003.200(c) and (d), the OIG may impose an 
assessment for each individual violation of Sec. 1003.200, of not more 
than 3 times the amount claimed for each item or service.
    (2) For violations of Sec. 1003.200(b)(4), the OIG may impose an 
assessment of not more than 3 times--
    (i) The amount claimed for each separately billable item or service 
provided, furnished, ordered, or prescribed by an excluded individual or 
entity or
    (ii) The total costs (including salary, benefits, taxes, and other 
money or items of value) related to the excluded individual or entity 
incurred by the person that employs, contracts with, or otherwise 
arranges for an excluded individual or entity to provide, furnish, 
order, or prescribe a non-separately-billable item or service.
    (3) For violations of Sec. 1003.200(b)(7), the OIG may impose an 
assessment of not more than 3 times the total amount claimed for each 
item or service for which payment was made based upon the application 
containing the false statement, omission, or misrepresentation of 
material fact.



Sec. 1003.220  Determinations regarding the amount of penalties
and assessments and the period of exclusion.

    In considering the factors listed in Sec. 1003.140--
    (a) It should be considered a mitigating circumstance if all the 
items or services or violations included in the action brought under 
this part were of the same type and occurred within a short period of 
time, there were few such items or services or violations, and the total 
amount claimed or requested for such items or services was less than 
$5,000.
    (b) Aggravating circumstances include--
    (1) The violations were of several types or occurred over a lengthy 
period of time;
    (2) There were many such items or services or violations (or the 
nature and circumstances indicate a pattern of claims or requests for 
payment for such items or services or a pattern of violations);
    (3) The amount claimed or requested for such items or services, or 
the amount of the overpayment was $50,000 or more;

[[Page 1091]]

    (4) The violation resulted, or could have resulted, in patient harm, 
premature discharge, or a need for additional services or subsequent 
hospital admission; or
    (5) The amount or type of financial, ownership, or control interest 
or the degree of responsibility a person has in an entity was 
substantial with respect to an action brought under Sec. 
1003.200(b)(3).



   Subpart C_CMPs, Assessments, and Exclusions for Anti-Kickback and 
                   Physician Self-Referral Violations

    Source: 81 FR 88357, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.300  Basis for civil money penalties, assessments, 
and exclusions.

    The OIG may impose a penalty, an assessment, and an exclusion 
against any person who it determines in accordance with this part--
    (a) Has not refunded on a timely basis, as defined in Sec. 
1003.110, amounts collected as a result of billing an individual, third 
party payer, or other entity for a designated health service furnished 
pursuant to a prohibited referral as described in 42 CFR 411.353.
    (b) Is a physician or other person who enters into any arrangement 
or scheme (such as a cross-referral arrangement) that the physician or 
other person knows, or should know, has a principal purpose of ensuring 
referrals by the physician to a particular person that, if the physician 
directly made referrals to such person, would be in violation of the 
prohibitions of 42 CFR 411.353.
    (c) Has knowingly presented, or caused to be presented, a claim that 
is for a payment that such person knows, or should know, may not be made 
under 42 CFR 411.353;
    (d) Has violated section 1128B(b) of the Act by unlawfully offering, 
paying, soliciting, or receiving remuneration to induce or in return for 
the referral of business paid for, in whole or in part, by Medicare, 
Medicaid, or other Federal health care programs.



Sec. 1003.310  Amount of penalties and assessments.

    (a) Penalties.\2\ The OIG may impose a penalty of not more than--
---------------------------------------------------------------------------

    \2\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (1) $15,000 for each claim or bill for a designated health service, 
as defined in Sec. 411.351 of this title, that is subject to a 
determination under Sec. 1003.300(a) or (c);
    (2) $100,000 for each arrangement or scheme that is subject to a 
determination under Sec. 1003.300(b); and
    (3) $50,000 for each offer, payment, solicitation, or receipt of 
remuneration that is subject to a determination under Sec. 1003.300(d).
    (b) Assessments. The OIG may impose an assessment of not more than 3 
times--
    (1) The amount claimed for each designated health service that is 
subject to a determination under Sec. 1003.300(a), (b), or (c).
    (2) The total remuneration offered, paid, solicited, or received 
that is subject to a determination under Sec. 1003.300(d). Calculation 
of the total remuneration for purposes of an assessment shall be without 
regard to whether a portion of such remuneration was offered, paid, 
solicited, or received for a lawful purpose.



Sec. 1003.320  Determinations regarding the amount of penalties and 
assessments and the period of exclusion.

    In considering the factors listed in Sec. 1003.140:
    (a) It should be considered a mitigating circumstance if all the 
items, services, or violations included in the action brought under this 
part were of the same type and occurred within a short period of time; 
there were few such items, services, or violations; and the total amount 
claimed or requested for such items or services was less than $5,000.
    (b) Aggravating circumstances include--
    (1) The violations were of several types or occurred over a lengthy 
period of time;
    (2) There were many such items, services, or violations (or the 
nature

[[Page 1092]]

and circumstances indicate a pattern of claims or requests for payment 
for such items or services or a pattern of violations);
    (3) The amount claimed or requested for such items or services or 
the amount of the remuneration was $50,000 or more; or
    (4) The violation resulted, or could have resulted, in harm to the 
patient, a premature discharge, or a need for additional services or 
subsequent hospital admission.



 Subpart D_CMPs and Assessments for Contracting Organization Misconduct

    Source: 81 FR 88357, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.400  Basis for civil money penalties and assessments.

    (a) All contracting organizations. The OIG may impose a penalty 
against any contracting organization that--
    (1) Fails substantially to provide an enrollee with medically 
necessary items and services that are required (under the Act, 
applicable regulations, or contract with the Department or a State) to 
be provided to such enrollee and the failure adversely affects (or has 
the substantial likelihood of adversely affecting) the enrollee;
    (2) Imposes a premium on an enrollee in excess of the amounts 
permitted under the Act;
    (3) Engages in any practice that would reasonably be expected to 
have the effect of denying or discouraging enrollment by beneficiaries 
whose medical condition or history indicates a need for substantial 
future medical services, except as permitted by the Act;
    (4) Misrepresents or falsifies information furnished to a person 
under sections 1857, 1860D-12, 1876, or 1903(m) of the Act;
    (5) Misrepresents or falsifies information furnished to the 
Secretary or a State, as applicable, under sections 1857, 1860D-12, 
1876, or 1903(m) of the Act;
    (6) Fails to comply with the requirements of 42 CFR 417.479(d) 
through (i) for Medicare and 42 CFR 417.479(d) through (g) and (i) for 
Medicaid regarding certain prohibited incentive payments to physicians; 
or
    (7) Fails to comply with applicable requirements of the Act 
regarding prompt payment of claims.
    (b) All Medicare contracting organizations. The OIG may impose a 
penalty against any contracting organization with a contract under 
section 1857, 1860D-12, or 1876 of the Act that--
    (1) Acts to expel or to refuse to reenroll a beneficiary in 
violation of the Act; or
    (2) Employs or contracts with a person excluded, under section 1128 
or 1128A of the Act, from participation in Medicare for the provision of 
health care, utilization review, medical social work, or administrative 
services, or employs or contracts with any entity for the provision of 
such services (directly or indirectly) through an excluded person.
    (c) Medicare Advantage and Part D contracting organizations. The OIG 
may impose a penalty, and for Sec. 1003.400(c)(4) or (5), an 
assessment, against a contracting organization with a contract under 
section 1857 or 1860D-12 of the Act that:
    (1) Enrolls an individual without the individual's (or his or her 
designee's) prior consent, except as provided under subparagraph (C) or 
(D) of section 1860D-1(b)(1) of the Act;
    (2) Transfers an enrollee from one plan to another without the 
individual's (or his or her designee's) prior consent;
    (3) Transfers an enrollee solely for the purpose of earning a 
commission;
    (4) Fails to comply with marketing restrictions described in 
subsection (h) or (j) of section 1851 of the Act or applicable 
implementing regulations or guidance; or
    (5) Employs or contracts with any person who engages in the conduct 
described in paragraphs (a) through (c) of this section.
    (d) Medicare Advantage contracting organizations. The OIG may impose 
a penalty against a contracting organization with a contract under 
section 1857 of the Act that fails to comply with the requirements of 
section 1852(j)(3) or 1852(k)(2)(A)(ii) of the Act.
    (e) Medicaid contracting organizations. The OIG may impose a penalty 
against

[[Page 1093]]

any contracting organization with a contract under section 1903(m) of 
the Act that acts to discriminate among individuals in violation of the 
Act, including expulsion or refusal to reenroll an individual or 
engaging in any practice that would reasonably be expected to have the 
effect of denying or discouraging enrollment by eligible individuals 
with the contracting organization whose medical condition or history 
indicates a need for substantial future medical services.



Sec. 1003.410  Amount of penalties and assessments for Contracting
Organization.

    (a) Penalties.\3\ (1) The OIG may impose a penalty of up to $25,000 
for each individual violation under Sec. 1001.400, except as provided 
in this section.
---------------------------------------------------------------------------

    \3\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (2) The OIG may impose a penalty of up to $100,000 for each 
individual violation under Sec. 1003.400(a)(3), (a)(5), or (e).
    (b) Additional penalties. In addition to the penalties described in 
paragraph (a) of this section, the OIG may impose--
    (1) An additional penalty equal to double the amount of excess 
premium charged by the contracting organization for each individual 
violation of Sec. 1003.400(a)(2). The excess premium amount will be 
deducted from the penalty and returned to the enrollee.
    (2) An additional $15,000 \4\ penalty for each individual expelled 
or not enrolled in violation of Sec. 1003.400(a)(3) or (e).
---------------------------------------------------------------------------

    \4\ This penalty amount is adjusted for inflation annually. Adjusted 
amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (c) Assessments. The OIG may impose an assessment against a 
contracting organization with a contract under section 1857 or 1860D-12 
of the Act (Medicare Advantage or Part D) of not more than the amount 
claimed in violation of Sec. 1003.400(a)(4) or (a)(5) on the basis of 
the misrepresentation or falsified information involved.
    (d) The OIG may impose a penalty or, when applicable, an assessment, 
against a contracting organization with a contract under section 1857 or 
1860D-12 of the Act (Medicare Advantage or Part D) if any of its 
employees, agents, or contracting providers or suppliers engages in any 
of the conduct described in Sec. 1003.400(a) through (d).



Sec. 1003.420  Determinations regarding the amount of penalties and
assessments.

    In considering the factors listed in Sec. 1003.140, aggravating 
circumstances include--
    (a) Such violations were of several types or occurred over a lengthy 
period of time;
    (b) There were many such violations (or the nature and circumstances 
indicate a pattern of incidents);
    (c) The amount of money, remuneration, damages, or tainted claims 
involved in the violation was $15,000 or more; or
    (d) Patient harm, premature discharge, or a need for additional 
services or subsequent hospital admission resulted, or could have 
resulted, from the incident; and
    (e) The contracting organization knowingly or routinely engaged in 
any prohibited practice that acted as an inducement to reduce or limit 
medically necessary services provided with respect to a specific 
enrollee in the organization.



           Subpart E_CMPs and Exclusions for EMTALA Violations

    Source: 81 FR 88357, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.500  Basis for civil money penalties and exclusions.

    (a) The OIG may impose a penalty against any participating hospital 
with an emergency department or specialized capabilities or facilities 
for each negligent violation of section 1867 of the Act or Sec. 489.24 
(other than Sec. 489.24(j)) of this title.
    (b) The OIG may impose a penalty against any responsible physician 
for each--
    (1) Negligent violation of section 1867 of the Act;
    (2) Certification signed under section 1867(c)(l)(A) of the Act if 
the physician knew, or should have known, that the benefits of transfer 
to another facility did not outweigh the risks of such a transfer; or

[[Page 1094]]

    (3) Misrepresentation made concerning an individual's condition or 
other information, including a hospital's obligations under section 1867 
of the Act.
    (c) The OIG may, in lieu of or in addition to any penalty available 
under this subpart, exclude any responsible physician who commits a 
gross and flagrant, or repeated, violation of this subpart from 
participation in Federal health care programs.
    (d) For purposes of this subpart, a ``gross and flagrant violation'' 
is a violation that presents an imminent danger to the health, safety, 
or well-being of the individual who seeks examination and treatment or 
places that individual unnecessarily in a high-risk situation.



Sec. 1003.510  Amount of penalties.

    The OIG may impose \5\--
---------------------------------------------------------------------------

    \5\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (a) Against each participating hospital, a penalty of not more than 
$50,000 for each individual violation, except that if the participating 
hospital has fewer than 100 State-licensed, Medicare-certified beds on 
the date the penalty is imposed, the penalty will not exceed $25,000 for 
each violation, and
    (b) Against each responsible physician, a penalty of not more than 
$50,000 for each individual violation.



Sec. 1003.520  Determinations regarding the amount of penalties and
the period of exclusion.

    In considering the factors listed in Sec. 1003.140,
    (a) It should be considered a mitigating circumstance if a hospital 
took appropriate and timely corrective action in response to the 
violation. For purposes of this subpart, corrective action must be 
completed prior to CMS initiating an investigation of the hospital for 
violations of section 1867 of the Act and must include disclosing the 
violation to CMS prior to CMS receiving a complaint regarding the 
violation from another source or otherwise learning of the violation.
    (b) Aggravating circumstances include:
    (1) Requesting proof of insurance, prior authorization, or a 
monetary payment prior to appropriately screening or initiating 
stabilizing treatment for an emergency medical condition, or requesting 
a monetary payment prior to stabilizing an emergency medical condition;
    (2) Patient harm, or risk of patient harm, resulted from the 
incident; or
    (3) The individual presented to the hospital with a request for 
examination or treatment of a medical condition that was an emergency 
medical condition, as defined by Sec. 489.24(b) of this title.



               Subpart F_CMPs for Section 1140 Violations

    Source: 81 FR 88357, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.600  Basis for civil money penalties.

    (a) The OIG may impose a penalty against any person who it 
determines in accordance with this part has used the words, letters, 
symbols, or emblems as defined in paragraph (b) of this section in such 
a manner that such person knew, or should have known, would convey, or 
in a manner that reasonably could be interpreted or construed as 
conveying, the false impression that an advertisement, a solicitation, 
or other item was authorized, approved, or endorsed by the Department or 
CMS or that such person or organization has some connection with or 
authorization from the Department or CMS.
    (b) Civil money penalties may be imposed, regardless of the use of a 
disclaimer of affiliation with the United States Government, the 
Department, or its programs, for misuse of--
    (1) The words ``Department of Health and Human Services,'' ``Health 
and Human Services,'' ``Centers for Medicare & Medicaid Services,'' 
``Medicare,'' or ``Medicaid'' or any other combination or variations of 
such words;
    (2) The letters ``DHHS,'' ``HHS,'' or ``CMS,'' or any other 
combination or variation of such letters; or

[[Page 1095]]

    (3) A symbol or an emblem of the Department or CMS (including the 
design of, or a reasonable facsimile of the design of, the Medicare 
card, the check used for payment of benefits under Title II, or 
envelopes or other stationery used by the Department or CMS) or any 
other combination or variation of such symbols or emblems.
    (c) Civil money penalties will not be imposed against any agency or 
instrumentality of a State, or political subdivision of the State, that 
uses any symbol or emblem or any words or letters that specifically 
identify that agency or instrumentality of the State or political 
subdivision.



Sec. 1003.610  Amount of penalties.

    (a) The OIG may impose a penalty of not more than \6\--
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    \6\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (1) $5,000 for each individual violation resulting from the misuse 
of Departmental, CMS, or Medicare or Medicaid program words, letters, 
symbols, or emblems as described in Sec. 1003.600(a) relating to 
printed media;
    (2) $5,000 for each individual violation in the case of such misuse 
related to an electronic communication, Web page, or telemarketing 
solicitation;
    (3) $25,000 for each individual violation in the case of such misuse 
related to a broadcast or telecast.
    (b) For purposes of this paragraph, a violation is defined as--
    (1) In the case of a direct mailing solicitation or advertisement, 
each separate piece of mail that contains one or more words, letters, 
symbols, or emblems related to a determination under Sec. 1003.600(a);
    (2) In the case of a printed solicitation or advertisement, each 
reproduction, reprinting, or distribution of such item related to a 
determination under Sec. 1003.600(a);
    (3) In the case of a broadcast or telecast, each airing of a single 
commercial or solicitation related to a determination under Sec. 
1003.600(a);
    (4) In the case of an electronic communication, each dissemination, 
viewing, or accessing of the electronic communication that contains one 
or more words, letters, symbols, or emblems related to a determination 
under Sec. 1003.600(a);
    (5) In the case of a Web page accessed by a computer or other 
electronic means, each instance in which the Web page was viewed or 
accessed and that Web page contains one or more words, letters, symbols, 
or emblems related to a determination under Sec. 1003.600(a); and
    (6) In the case of a telemarketing solicitation, each individual 
unsolicited telephone call regarding an item or service under Medicare 
or Medicaid related to a determination under Sec. 1003.600(a).



Sec. 1003.620  Determinations regarding the amount of penalties.

    (a) In considering the factors listed in Sec. 1003.140, the 
following circumstances are to be considered--
    (1) The nature and objective of the advertisement, solicitation, or 
other communication and the degree to which it had the capacity to 
deceive members of the public;
    (2) The frequency and scope of the violation and whether a specific 
segment of the population was targeted; and
    (3) The prior history of the individual, organization, or entity in 
its willingness or refusal to comply with a formal or informal request 
to correct violations.
    (b) The use of a disclaimer of affiliation with the United States 
Government, the Department, or its programs will not be considered as a 
mitigating factor in determining the amount of penalty in accordance 
with Sec. 1003.600(a).

Subpart G [Reserved]



  Subpart H_CMPs for Adverse Action Reporting and Disclosure Violations

    Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.800  Basis for civil money penalties.

    The OIG may impose a penalty against any person (including an 
insurance company) who it determines--

[[Page 1096]]

    (a) Fails to report information concerning--
    (1) A payment made under an insurance policy, self-insurance, or 
otherwise for the benefit of a physician, dentist, or other health care 
practitioner in settlement of, or in satisfaction in whole or in part 
of, a medical malpractice claim or action or a judgment against such a 
physician, dentist, or other practitioner in accordance with section 421 
of Public Law 99-660 (42 U.S.C. 11131) and as required by regulations at 
45 CFR part 60 or
    (2) An adverse action required to be reported under section 1128E, 
as established by section 221 of Public Law 104-191.
    (b) Improperly discloses, uses, or permits access to information 
reported in accordance with Part B of Title IV of Public Law 99-660 (42 
U.S.C. 11137) or regulations at 45 CFR part 60. (The disclosure of 
information reported in accordance with Part B of Title IV in response 
to a subpoena or a discovery request is considered an improper 
disclosure in violation of section 427 of Public Law 99-660. However, 
disclosure or release by an entity of original documents or underlying 
records from which the reported information is obtained or derived is 
not considered an improper disclosure in violation of section 427 of 
Public Law 99-660.)



Sec. 1003.810  Amount of penalties.

    The OIG may impose a penalty of not more than \7\--
---------------------------------------------------------------------------

    \7\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (a) $11,000 for each payment for which there was a failure to report 
required information in accordance with Sec. 1003.800(a)(1) or for each 
improper disclosure, use, or access to information in accordance with a 
determination under Sec. 1003.800(b); and
    (b) $25,000 against a health plan for each failure to report 
information on an adverse action required to be reported in accordance 
with section 1128E of the Act and Sec. 1003.800(a)(2).



Sec. 1003.820  Determinations regarding the amount of penalties.

    In determining the amount of any penalty in accordance with this 
subpart, the OIG will consider the factors listed in Sec. 1003.140.



           Subpart I_CMPs for Select Agent Program Violations

    Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.900  Basis for civil money penalties.

    The OIG may impose a penalty against any person who it determines in 
accordance with this part is involved in the possession or use in the 
United States, receipt from outside the United States or transfer within 
the United States, of select agents and toxins in violation of sections 
351A(b) or (c) of the Public Health Service Act or 42 CFR part 73.



Sec. 1003.910  Amount of penalties.

    For each individual violation of section 351A(b) or (c) of the 
Public Health Service Act or 42 CFR part 73, the OIG may impose a 
penalty of not more than $250,000 in the case of an individual, and not 
more than $500,000 in the case of any other person.\8\
---------------------------------------------------------------------------

    \8\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------



Sec. 1003.920  Determinations regarding the amount of penalties.

    In considering the factors listed in Sec. 1003.140, aggravating 
circumstances include:
    (a) The Responsible Official participated in or knew, or should have 
known, of the violation;
    (b) The violation was a contributing factor to an unauthorized 
individual's access to or possession of a select agent or toxin, an 
individual's exposure to a select agent or toxin, or the unauthorized 
removal of a select agent or toxin from the person's physical location 
as identified on the person's certificate of registration; or

[[Page 1097]]

    (c) The person previously received an observation, finding, or other 
statement of deficiency from the Department or the Department of 
Agriculture for the same or substantially similar conduct.



 Subpart J_CMPs, Assessments, and Exclusions for Beneficiary Inducement 
                               Violations

    Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.1000  Basis for civil money penalties, assessments, and
exclusions.

    (a) The OIG may impose a penalty, an assessment, and an exclusion 
against any person who it determines offers or transfers remuneration 
(as defined in Sec. 1003.110) to any individual eligible for benefits 
under Medicare or a State health care program that such person knows, or 
should know, is likely to influence such individual to order or to 
receive from a particular provider, practitioner, or supplier, any item 
or service for which payment may be made, in whole or in part, under 
Medicare or a State health care program.
    (b) The OIG may impose a penalty against any person who it 
determines offered any financial or other incentive for an individual 
entitled to benefits under Medicare not to enroll, or to terminate 
enrollment, under a group health plan or a large group health plan that 
would, in the case of such enrollment, be a primary plan as defined in 
section 1862(b)(2)(A) of the Act.



Sec. 1003.1010  Amount of penalties and assessments.

    The OIG may impose a penalty of not more than \9\--
---------------------------------------------------------------------------

    \9\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (a) $10,000 for each item or service for which payment may be made, 
in whole or in part, under Medicare or a State health care program, 
ordered by or received from a particular provider, practitioner, or 
supplier for a beneficiary who was offered or received remuneration in 
violation of Sec. 1003.1000(a) that was likely to influence the 
beneficiary to order or receive the item or service from the provider, 
practitioner, or supplier, and an assessment of not more than 3 times 
the amount claimed for each such item or service and
    (b) $5,000 for each individual violation of Sec. 1003.1000(b).



Sec. 1003.1020  Determinations regarding the amount of penalties and 
assessments and the period of exclusion.

    In determining the amount of any penalty or assessment or the period 
of exclusion under this subpart, the OIG will consider the factors 
listed in Sec. 1003.140, as well as the amount of remuneration or the 
amount or nature of any other incentive.



      Subpart K_CMPs for the Sale of Medicare Supplemental Policies

    Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.1100  Basis for civil money penalties.

    The OIG may impose a penalty against any person who--
    (a) Knowingly and willfully makes or causes to be made or induces or 
seeks to induce the making of any false statement or representation of a 
material fact with respect to--
    (1) The compliance of any policy with the standards and requirements 
for Medicare supplemental policies set forth in section 1882(c) of the 
Act or in promulgating regulations, or
    (2) The use of the emblem designed by the Secretary under section 
1882(a) of the Act for use as an indication that a policy has received 
the Secretary's certification;
    (b) Falsely assumes or pretends to be acting, or misrepresents in 
any way that he or she is acting, under the authority of or in 
association with Medicare or any Federal agency, for the purpose of 
selling or attempting to sell insurance, or in such pretended character 
demands, or obtains money, paper, documents, or anything of value;
    (c) Knowingly, directly, or through his or her agent, mails or 
causes to be mailed any matter for the advertising, solicitation, or 
offer for sale of a Medicare supplemental policy, or the delivery of 
such a policy, in or into any

[[Page 1098]]

State in which such policy has not been approved by the State 
commissioner or superintendent of insurance;
    (d) Issues or sells to any individual entitled to benefits under 
Part A or enrolled under Part B of Medicare--
    (1) A health insurance policy with knowledge that the policy 
duplicates health benefits to which the individual is otherwise entitled 
under Medicare or Medicaid,
    (2) A health insurance policy (other than a Medicare supplemental 
policy) with knowledge that the policy duplicates health benefits to 
which the individual is otherwise entitled, other than benefits to which 
the individual is entitled under a requirement of State or Federal law,
    (3) In the case of an individual not electing a Part C plan, a 
Medicare supplemental policy with knowledge that the individual is 
entitled to benefits under another Medicare supplemental policy, or
    (4) In the case of an individual electing a Part C plan, a Medicare 
supplemental policy with knowledge that the policy duplicates health 
benefits to which the individual is otherwise entitled under the Part C 
plan or under another Medicare supplemental policy;
    (e) Issues or sells a health insurance policy (other than a policy 
described in section 1882(d)(3)(A)(vi)(III)) to any individual entitled 
to benefits under Medicare Part A or enrolled under Medicare Part B who 
is applying for a health insurance policy and fails to furnish the 
appropriate disclosure statement described in section 
1882(d)(3)(A)(vii); or
    (f) Issues or sells a Medicare supplemental policy to any individual 
eligible for benefits under Part A or enrolled under Medicare Part B 
without obtaining the written statement or the written acknowledgment 
described in section 1882(d)(3)(B) of the Act.



Sec. 1003.1110  Amount of penalties.

    The OIG may impose a penalty of not more than \10\--
---------------------------------------------------------------------------

    \10\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (a) $5,000 for each individual violation of Sec. 1003.1100(a), (b), 
or (c).
    (b) $25,000 for each individual violation of Sec. 1003.1100(d), 
(e), or (f) by a seller who is also the issuer of the policy; and
    (c) $15,000 for each individual violation of Sec. 1003.1100(d), 
(e), or (f) by a seller who is not the issuer of the policy.



Sec. 1003.1120  Determinations regarding the amount of penalties.

    In determining the amount of the penalty in accordance with this 
subpart, the OIG will consider the factors listed in Sec. 1003.140.



                 Subpart L_CMPs for Drug Price Reporting

    Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.1200  Basis for civil money penalties.

    The OIG may impose a penalty against--
    (a) Any wholesaler, manufacturer, or direct seller of a covered 
outpatient drug that--
    (1) Refuses a request for information by, or
    (2) Knowingly provides false information to, the Secretary about 
charges or prices in connection with a survey being conducted pursuant 
to section 1927(b)(3)(B) of the Act; and
    (b) Any manufacturer with an agreement under section 1927 of the Act 
that--
    (1) Fails to provide any information required by section 
1927(b)(3)(A) of the Act by the deadlines specified therein, or
    (2) Knowingly provides any item information required by section 
1927(b)(3)(A) or (B) of the Act that is false.



Sec. 1003.1210  Amount of penalties.

    The OIG may impose a penalty of not more than \11\--
---------------------------------------------------------------------------

    \11\ The penalty amounts in this section are adjusted for inflation 
annually. Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------

    (a) $100,000 for each individual violation of Sec. 1003.1200(a) or 
Sec. 1003.1200(b)(2); and

[[Page 1099]]

    (b) $10,000 for each day that such information has not been provided 
in violation of Sec. 1003.1200(b)(1).



Sec. 1003.1220  Determinations regarding the amount of penalties.

    In determining the amount of the penalty in accordance with this 
subpart, the OIG will consider the factors listed in Sec. 1003.140.



    Subpart M_CMPs for Notifying a Skilled Nursing Facility, Nursing 
   Facility, Home Health Agency, or Community Care Setting of a Survey

    Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.1300  Basis for civil money penalties.

    The OIG may impose a penalty against any individual who notifies, or 
causes to be notified, a skilled nursing facility, nursing facility, 
home health agency, a community care setting, of the time or date on 
which a survey pursuant to sections 1819(g)(2)(A), 1919(g)(2)(A), 
1891(c)(1), or 1929(i) of the Act is scheduled to be conducted.



Sec. 1003.1310  Amount of penalties.

    The OIG may impose a penalty of not more than $2,000 for each 
individual violation of Sec. 1003.1300.\12\
---------------------------------------------------------------------------

    \12\ This penalty amount is adjusted for inflation annually. 
Adjusted amounts are published at 45 CFR part 102.
---------------------------------------------------------------------------



Sec. 1003.1320  Determinations regarding the amount of penalties.

    In determining the amount of the penalty in accordance with this 
subpart, the OIG will consider the factors listed in Sec. 1003.140.

Subpart N [Reserved]



   Subpart O_Procedures for the Imposition of CMPs, Assessments, and 
                               Exclusions

    Source: 81 FR 88364, Dec. 7, 2016, unless otherwise noted.



Sec. 1003.1500  Notice of proposed determination.

    (a) If the OIG proposes a penalty and, when applicable, an 
assessment, or proposes to exclude a respondent from participation in 
all Federal health care programs, as applicable, in accordance with this 
part, the OIG must serve on the respondent, in any manner authorized by 
Rule 4 of the Federal Rules of Civil Procedure, written notice of the 
OIG's intent to impose a penalty, an assessment, and an exclusion, as 
applicable. The notice will include--
    (1) Reference to the statutory basis for the penalty, assessment, 
and exclusion;
    (2) A description of the violation for which the penalty, 
assessment, and exclusion are proposed (except in cases in which the OIG 
is relying upon statistical sampling in accordance with Sec. 1003.1580, 
in which case the notice shall describe those claims and requests for 
payment constituting the sample upon which the OIG is relying and will 
briefly describe the statistical sampling technique used by the OIG);
    (3) The reason why such violation subjects the respondent to a 
penalty, an assessment, and an exclusion,
    (4) The amount of the proposed penalty and assessment, and the 
length of the period of proposed exclusion (where applicable);
    (5) Any factors and circumstances described in this part that were 
considered when determining the amount of the proposed penalty and 
assessment and the length of the period of exclusion;
    (6) Instructions for responding to the notice, including--
    (i) A specific statement of the respondent's right to a hearing and
    (ii) A statement that failure to request a hearing within 60 days 
permits the imposition of the proposed penalty, assessment, and 
exclusion without right of appeal; and
    (7) In the case of a notice sent to a respondent who has an 
agreement under section 1866 of the Act, the notice also indicates that 
the imposition of an exclusion may result in the termination of the 
respondent's provider agreement in accordance with section 1866(b)(2)(C) 
of the Act.

[[Page 1100]]

    (b) Any person upon whom the OIG has proposed the imposition of a 
penalty, an assessment, or an exclusion may appeal such proposed 
penalty, assessment, or exclusion to the Departmental Appeals Board in 
accordance with 42 CFR 1005.2. The provisions of 42 CFR part 1005 govern 
such appeals.
    (c) If the respondent fails, within the time period permitted, to 
exercise his or her right to a hearing under this section, any 
exclusion, penalty, or assessment becomes final.



Sec. 1003.1510  Failure to request a hearing.

    If the respondent does not request a hearing within 60 days after 
the notice prescribed by Sec. 1003.1500(a) is received, as determined 
by 42 CFR 1005.2(c), by the respondent, the OIG may impose the proposed 
penalty, assessment, and exclusion, or any less severe penalty, 
assessment, or exclusion. The OIG shall notify the respondent in any 
manner authorized by Rule 4 of the Federal Rules of Civil Procedure of 
any penalty, assessment, and exclusion that have been imposed and of the 
means by which the respondent may satisfy the judgment. The respondent 
has no right to appeal a penalty, an assessment, or an exclusion with 
respect to which he or she has not made a timely request for a hearing 
under 42 CFR 1005.2.



Sec. 1003.1520  Collateral estoppel.

    (a) Where a final determination pertaining to the respondent's 
liability for acts that violate this part has been rendered in any 
proceeding in which the respondent was a party and had an opportunity to 
be heard, the respondent shall be bound by such determination in any 
proceeding under this part.
    (b) In a proceeding under this part, a person is estopped from 
denying the essential elements of the criminal offense if the 
proceeding--
    (1) Is against a person who has been convicted (whether upon a 
verdict after trial or upon a plea of guilty or nolo contendere) of a 
Federal crime charging fraud or false statements, and
    (2) Involves the same transactions as in the criminal action.



Sec. 1003.1530  Settlement.

    The OIG has exclusive authority to settle any issues or case without 
consent of the ALJ.



Sec. 1003.1540  Judicial review.

    (a) Section 1128A(e) of the Act authorizes judicial review of a 
penalty, an assessment, or an exclusion that has become final. The only 
matters subject to judicial review are those that the respondent raised 
pursuant to 42 CFR 1005.21, unless the court finds that extraordinary 
circumstances existed that prevented the respondent from raising the 
issue in the underlying administrative appeal.
    (b) A respondent must exhaust all administrative appeal procedures 
established by the Secretary or required by law before a respondent may 
bring an action in Federal court, as provided in section 1128A(e) of the 
Act, concerning any penalty, assessment, or exclusion imposed pursuant 
to this part.
    (c) Administrative remedies are exhausted when a decision becomes 
final in accordance with 42 CFR 1005.21(j).



Sec. 1003.1550  Collection of penalties and assessments.

    (a) Once a determination by the Secretary has become final, 
collection of any penalty and assessment will be the responsibility of 
CMS, except in the case of the Maternal and Child Health Services Block 
Grant Program, in which the collection will be the responsibility of the 
Public Health Service (PHS); in the case of the Social Services Block 
Grant program, in which the collection will be the responsibility of the 
Administration for Children and Families; and in the case of violations 
of subpart I, collection will be the responsibility of the Program 
Support Center (PSC).
    (b) A penalty or an assessment imposed under this part may be 
compromised by the OIG and may be recovered in a civil action brought in 
the United States district court for the district where the claim was 
presented or where the respondent resides.
    (c) The amount of penalty or assessment, when finally determined, or 
the amount agreed upon in compromise, may be deducted from any sum then 
or

[[Page 1101]]

later owing by the United States Government or a State agency to the 
person against whom the penalty or assessment has been assessed.
    (d) Matters that were raised, or that could have been raised, in a 
hearing before an ALJ or in an appeal under section 1128A(e) of the Act 
may not be raised as a defense in a civil action by the United States to 
collect a penalty under this part.



Sec. 1003.1560  Notice to other agencies.

    (a) Whenever a penalty, an assessment, or an exclusion becomes 
final, the following organizations and entities will be notified about 
such action and the reasons for it: The appropriate State or local 
medical or professional association; the appropriate quality improvement 
organization; as appropriate, the State agency that administers each 
State health care program; the appropriate Medicare carrier or 
intermediary; the appropriate State or local licensing agency or 
organization (including the Medicare and Medicaid State survey 
agencies); and the long-term-care ombudsman. In cases involving 
exclusions, notice will also be given to the public of the exclusion and 
its effective date.
    (b) When the OIG proposes to exclude a nursing facility under this 
part, the OIG will, at the same time the facility is notified, notify 
the appropriate State licensing authority, the State Office of Aging, 
the long-term-care ombudsman, and the State Medicaid agency of the OIG's 
intention to exclude the facility.



Sec. 1003.1570  Limitations.

    No action under this part will be entertained unless commenced, in 
accordance with Sec. 1003.1500(a), within 6 years from the date on 
which the violation occurred.



Sec. 1003.1580  Statistical sampling.

    (a) In meeting the burden of proof in 42 CFR 1005.15, the OIG may 
introduce the results of a statistical sampling study as evidence of the 
number and amount of claims and/or requests for payment, as described in 
this part, that were presented, or caused to be presented, by the 
respondent. Such a statistical sampling study, if based upon an 
appropriate sampling and computed by valid statistical methods, shall 
constitute prima facie evidence of the number and amount of claims or 
requests for payment, as described in this part.
    (b) Once the OIG has made a prima facie case, as described in 
paragraph (a) of this section, the burden of production shall shift to 
the respondent to produce evidence reasonably calculated to rebut the 
findings of the statistical sampling study. The OIG will then be given 
the opportunity to rebut this evidence.



Sec. 1003.1590  Effect of exclusion.

    The effect of an exclusion will be as set forth in 42 CFR 1001.1901.



Sec. 1003.1600  Reinstatement.

    A person who has been excluded in accordance with this part may 
apply for reinstatement at the end of the period of exclusion. The OIG 
will consider any request for reinstatement in accordance with the 
provisions of 42 CFR 1001.3001 through 1001.3004.



PART 1004_IMPOSITION OF SANCTIONS ON HEALTH CARE PRACTITIONERS AND
PROVIDERS OF HEALTH CARE SERVICES BY A QUALITY IMPROVEMENT 
ORGANIZATION--Table of Contents



                      Subpart A_General Provisions

Sec.
1004.1 Scope and definitions.

      Subpart B_Sanctions Under the QIO Program; General Provisions

1004.10 Statutory obligations of practitioners and other persons.
1004.20 Sanctions.

                     Subpart C_QIO Responsibilities

1004.30 Basic responsibilities.
1004.40 Action on identification of a violation.
1004.50 Meeting with a practitioner or other person.
1004.60 QIO finding of a violation.
1004.70 QIO action on final finding of a violation.
1004.80 QIO report to the OIG.
1004.90 Basis for recommended sanction.

[[Page 1102]]

                     Subpart D_OIG Responsibilities

1004.100 Acknowledgement and review of report.
1004.110 Notice of sanction.

               Subpart E_Effect and Duration of Exclusion

1004.120 Effect of an exclusion on program payments and services.
1004.130 Reinstatement after exclusion.

                            Subpart F_Appeals

1004.140 Appeal rights.

    Authority: 42 U.S.C. 1302 and 1320c-5.

    Source: 60 FR 63640, Dec. 12, 1995, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1004.1  Scope and definitions.

    (a) Scope. This part implements section 1156 of the Act by--
    (1) Setting forth certain obligations imposed on practitioners and 
providers of services under Medicare;
    (2) Establishing criteria and procedures for the reports required 
from quality improvement organizations (QIOs) when there is failure to 
meet those obligations;
    (3) Specifying the policies and procedures for making determinations 
on violations and imposing sanctions; and
    (4) Defining the procedures for appeals by the affected party and 
the procedures for reinstatements.
    (b) Definitions. As used in this part, unless the context indicates 
otherwise--
    Dentist is limited to licensed doctors of dental surgery or dental 
medicine.
    Economically means the services are provided at the least expensive, 
medically appropriate type of setting or level of care available.
    Exclusion means that items and services furnished or ordered (or at 
the medical direction or on the prescription of a physician) by a 
specified health care practitioner, provider or other person during a 
specified period are not reimbursed under titles V, XVIII, XIX, or XX of 
the Social Security Act and all other Federal non-procurement programs.
    Gross and flagrant violation means a violation of an obligation has 
occurred in one or more instances which presents 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 service or services means services or items for which 
payment may be made (in whole or in part) under the Medicare or State 
health care programs.
    Health professional shortage area (HPSA) means an area designated by 
the Secretary and defined in 42 CFR 5.2.
    Metropolitan Statistical Area means an area as defined by the 
Executive Office of Management and Budget.
    Obligation means any of the obligations specified at section 1156(a) 
of the Act.
    Other person means a hospital or other health care facility, an 
organization or an agency that provides health care services or which 
payment may be made (in whole or in part) under the Medicare or State 
health care programs.
    Pattern or care means that the care under question has been 
demonstrated in more than three instances, each of which involved 
different admissions.
    Pharmacy professional is a term limited to individuals who are 
licensed or registered to provide pharmaceutical services.
    Podiatric professional is a term limited to licensed doctors of 
podiatric medicine.
    Practice area means the location where over 50 percent of the 
practitioner's or other person's patients are seen.
    Practitioner means a physician or other health care professional 
licensed under State law to practice his or her profession.
    Primary medical care professional is a term limited to:
    (i) Licensed doctors of medicine and doctors of osteopathy providing 
direct patient care who practice in the fields of general or family 
practice, general internal medicine, pediatrics, obstetrics and 
gynecology, surgery, and any other specialty that is not accommodated by 
the remaining specialty HPSA designator, or
    (ii) Those facilities where care and treatment is provided to 
patients with

[[Page 1103]]

health problems other than mental disorders.
    Pro area means the geographic area subject to review by a particular 
QIO.
    Provider means a hospital or other health care facility, agency, or 
organization.
    Psychiatric professional is a term limited to licensed doctors of 
medicine who limit their practice to psychiatry or to those facilities 
where care and treatment is limited to patients with mental disorders.
    Rural means any area outside an urban area.
    Rural health professional shortage area means any health 
professional shortage area located outside a Metropolitan Statistical 
Area.
    Sanction means an exclusion or monetary penalty that the Secretary 
may impose on a practitioner or other person as a result of a 
recommendation from a QIO.
    Serious risk includes situations that may involve the risk of 
unnecessary treatment, prolonged treatment, lack of treatment, incorrect 
treatment, medical complication, premature discharge, physiological or 
anatomical impairment, disability, or death.
    State health care program means a State plan approved under title 
XIX, any program receiving funds under title V or from an allotment to a 
State under such title, or any program receiving funds under title XX or 
from an allotment to a State under such title.
    Substantial violation in a substantial number of cases means a 
pattern of providing care, as defined in this section, 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.
    Urban means a Metropolitan Statistical Area as defined by the 
Executive Office of Management and Budget.
    Vision care professional is a term limited to licensed doctors of 
medicine who limit their practice to ophthalmology and to doctors of 
optometry.



      Subpart B_Sanctions Under the QIO Program; General Provisions



Sec. 1004.10  Statutory obligations of practitioners and other persons.

    It is the obligation of any health care practitioner or other person 
who furnishes or orders health care services that may be reimbursed 
under the Medicare or State health care programs to ensure, to the 
extent of his or her or its authority, that those services are--
    (a) Provided economically and only when, and to the extent, 
medically necessary;
    (b) Of a quality that meets professionally recognized standards of 
health care; and
    (c) Supported by evidence of medical necessity and quality in the 
form and fashion and at such time that the reviewing QIO may reasonably 
require (including copies of the necessary documentation and evidence of 
compliance with pre-admission or pre-procedure review requirements) to 
ensure that the practitioner or other person is meeting the obligations 
imposed by section 1156(a) of the Act.



Sec. 1004.20  Sanctions.

    In addition to any other sanction provided under the law, a 
practitioner or other person may be--
    (a) Excluded from participating in programs under titles V, XVIII, 
XIX, and XX of the Social Security Act for a period of no less than 1 
year; or
    (b) In lieu of exclusion and as a condition for continued 
participation in titles V, XVIII, XIX, and XX of the Act, if the 
violation involved the provision or ordering of health care services (or 
services furnished at the medical direction or on the prescription of a 
physician) that were medically improper or unnecessary, required to pay 
an amount of up to $10,000 for each instance in which improper or 
unnecessary services were furnished or ordered (or prescribed, if 
appropriate). The practitioner or other person will be required either 
to pay the monetary assessment within 6 months of the date of notice or 
have it deducted from any

[[Page 1104]]

sums the Federal Government owes the practitioner or other person.

[62 FR 23143, Apr. 29, 1997]



                     Subpart C_QIO Responsibilities



Sec. 1004.30  Basic responsibilities.

    (a) The QIO must use its authority or influence to enlist the 
support of other professional or government agencies to ensure that each 
practitioner or other person complies with the obligations specified in 
Sec. 1004.10.
    (b) When the QIO identifies situations where an obligation specified 
in Sec. 1004.10 is violated, it will afford the practitioner or other 
person reasonable notice and opportunity for discussion and, if 
appropriate, a suggested method for correcting the situation and a time 
period for a corrective action in accordance with Sec. Sec. 1004.40 and 
1004.60.
    (c) The QIO must submit a report to the OIG after the notice and 
opportunity provided under paragraph (b) of this section and, if 
appropriate, the opportunity to enter into and complete a corrective 
action plan (CAP) if the QIO finds that the practitioner or other person 
has--
    (1) Failed substantially to comply with any obligation in a 
substantial number of admissions; or
    (2) Grossly and flagrantly violated any obligation in one or more 
instances.
    (d) The QIO report to the OIG must comply with the provisions of 
Sec. 1004.80.
    (e) If a practitioner or other person relocates to another QIO area 
prior to a finding of a violation or sanction recommendation, and the 
originating QIO--
    (1) Is able to make a finding, the originating QIO must, as 
appropriate, close the case or forward a sanction recommendation to the 
OIG; or
    (2) Cannot make a finding, the originating QIO must forward all 
documentation regarding the case to the QIO with jurisdiction, and 
notify the practitioner or other person of this action.
    (f) The QIO must deny payment for services or items furnished or 
ordered (or at the medical direction or on the prescription of an 
excluded physician) by an excluded practitioner or other person when the 
QIO identifies the services or items. It must report the findings to the 
Centers for Medicare & Medicaid Services.



Sec. 1004.40  Action on identification of a violation.

    When a QIO identifies a violation, it must--
    (a) Indicate whether the violation is a gross and flagrant violation 
or is a substantial violation in a substantial number of cases; and
    (b) Send the practitioner or other person written notice of the 
identification of a violation containing the following information--
    (1) The obligation(s) involved;
    (2) The situation, circumstances or activity that resulted in a 
violation;
    (3) The authority and responsibility of the QIO to report violations 
of any obligation under section 1156(a) of the Act;
    (4) A suggested method for correcting the situation and a time 
period for corrective action, if appropriate;
    (5) The sanction that the QIO could recomment to the OIG;
    (6) The right of the practitioner or other person to submit to the 
QIO within 30 days of receipt of the notice additional information or a 
written request for a meeting with the QIO to review and discuss the 
finding, or both. The date of receipt is presumed to be 5 days after the 
date on the notice, unless there is a reasonable showing to the 
contrary. The notice will also state that if a meeting is requested--
    (i) It will be held within 30 days of receipt by the QIO of the 
request, but may be extended for good cause;
    (ii) The practitioner or other person may have an attorney present; 
and
    (iii) The attorney, if present, will be permitted to make opening 
and closing remarks, ask clarifying questions at the meeting and assist 
the practitioner or other person in presenting the testimony of expert 
witnesses who may appear on the practitioner's or other person's behalf; 
and
    (7) A copy of the material used by the QIO in arriving at its 
finding except for QIO deliberations, as set forth in Sec. 480.139 of 
this part.

[60 FR 63640, Dec. 12, 1995, as amended at 85 FR 72910, Nov. 16, 2020]

[[Page 1105]]



Sec. 1004.50  Meeting with a practitioner or other person.

    If the practitioner or other person requests a meeting with the 
QIO--
    (a) The QIO panel that meets with the practitioner or other person 
must consist of a minimum of 3 physicians;
    (b) No physician member of the QIO panel may be in direct economic 
competition with the practitioner or other person being considered for 
sanction;
    (c) The QIO must ensure that no physician member of the QIO panel 
has a substantial bias for or against the practitioner or other person 
being considered for sanction;
    (d) At least one member of the QIO panel meeting with the 
practitioner or other person should practice in a similar area, e.g., 
urban or rural, and at least one member of the panel must be in the same 
specialty (both requirements could be met by a single individual);
    (e) If the practitioner or other person has an attorney present, 
that attorney will be permitted to make opening and closing remarks, ask 
clarifying questions and assist the practitioner or other person in 
presenting the testimony of expert witnesses who may appear on the 
practitioner's or other person behalf;
    (f) The physician who recommends to the QIO that a practitioner or 
other person be sanctioned may not vote on that recommendation at the 
meeting;
    (g) The QIO may allow the practitioner or other person 5 working 
days after the meeting to provide the QIO additional relevant 
information that may affect its finding; and
    (h) A verbatim record must be made of the meeting and must be made 
available to the practitioner or other person promptly.



Sec. 1004.60  QIO finding of a violation.

    (a) On the basis of any additional information received, the QIO 
will affirm or modify its finding. If the QIO affirms its finding, it 
may suggest in writing a method for correcting the situation and a time 
period for corrective action. This CAP could correspond with, or be a 
continuation of, a prior CAP or be a new proposal based on additional 
information received by the QIO. If the finding has been resolved to the 
QIO's satisfaction, the QIO may modify its initial finding or 
recommendation or close the case.
    (b) The QIO must give written notice to the practitioner or other 
person of any action it takes as a result of the additional information 
received, as specified in Sec. 1004.70.
    (c) At least one member of the QIO participating in the process 
which resulted in a recommendation to the OIG that a practitioner or 
other person be sanctioned should practice in a similar geographic area, 
e.g. urban or rural, and at least one member of the panel must be in the 
same medical specialty. Both requirements can be met by a single 
individual. In addition, no one at the QIO who is a participant in such 
a finding may be in direct economic competition with, or have a 
substantial bias for or against, that practitioner or other person being 
recommended for sanction.



Sec. 1004.70  QIO action on final finding of a violation.

    If the finding is not resolved to the QIO's satisfaction as 
specified in Sec. 1004.60(a), the QIO must--
    (a) Submit its report and recommendation to the OIG;
    (b) Send the affected practitioner or other person a concurrent 
final notice, with a copy of all the material that is being forwarded to 
the OIG, advising that--
    (1) The QIO recommendation has been submitted to the OIG;
    (2) The practitioner or other person has 30 days from receipt of 
this final notice to submit any additional written material or 
documentary evidence to the OIG at its headquarters location. The date 
of receipt is presumed to be 5 days after the date on the notice, unless 
there is a reasonable showing to the contrary; and
    (3) Due to the 120-day statutory requirement specified in Sec. 
1004.100(e), the period for submitting additional information will not 
be extended and any material received by the OIG after the 30-day period 
will not be considered; and
    (c) Provide notice to the State medical board or to other 
appropriate licensing boards for other practitioner

[[Page 1106]]

types when it submits a report and recommendations to the OIG with 
respect to a physician or other person whom the board is responsible for 
licensing.



Sec. 1004.80  QIO report to the OIG.

    (a) Manner of reporting. If the violation(s) identified by the QIO 
have not been resolved, it must submit a report and recommendation to 
the OIG at the field office with jurisdiction.
    (b) Content of report. The QIO report must include the following 
information--
    (1) Identification of the practitioner or other person and, when 
applicable, the name of the director, administrator or owner of the 
entity involved;
    (2) The type of health care services involved;
    (3) A description of each failure to comply with an obligation, 
including specific dates, places, circumstances and other relevant 
facts;
    (4) Pertinent documentary evidence;
    (5) Copies of written correspondence, including reports of 
conversations with the practitioner or other person regarding the 
violation and, if applicable, a copy of the verbatim transcript of the 
meeting with the practitioner or other person;
    (6) The QIO's finding that an obligation under section 1156(a) of 
the Act has been violated and that the violation is substantial and has 
occurred in a substantial number of cases or is gross and flagrant;
    (7) A case-by-case analysis and evaluation of any additional 
information provided by the practitioner or other person in response to 
the QIO's initial finding;
    (8) A copy of the CAP that was developed and documentation of the 
results of such plan;
    (9) The number of admissions by the practitioner or other person 
reviewed by the QIO during the period in which the violation(s) were 
identified;
    (10) The professional qualifications of the QIO's reviewers; and
    (11) The QIO's sanction recommendation.
    (c) QIO recommendation. The QIO must specify in its report--
    (1) The sanction recommended;
    (2) The amount of the monetary penalty recommended, if applicable;
    (3) The period of exclusion recommended, if applicable;
    (4) The availability of alternative sources of services in the 
community, with supporting information; and
    (5) The county or counties in which the practitioner or other person 
furnishes services.

[60 FR 63640, Dec. 12, 1995, as amended at 62 FR 23143, Apr. 29, 1997]



Sec. 1004.90  Basis for recommended sanction.

    The QIO's specific recommendation must be based on documentation 
provided to the OIG showing its consideration of--
    (a) The type of offense involved;
    (b) The severity of the offense;
    (c) The deterrent value;
    (d) The practitioner's or other person's previous sanction record;
    (e) The availability of alternative sources of services in the 
community; and
    (f) Any other factors that the QIO considers relevant, such as the 
duration of the problem.



                     Subpart D_OIG Responsibilities



Sec. 1004.100  Acknowledgement and review of report.

    (a) Acknowledgement. The OIG will inform the QIO of the date it 
received the QIO's report and recommendation.
    (b) Review. The OIG will review the QIO report and recommendation to 
determine whether--
    (1) The QIO has followed the regulatory requirements of this part; 
and
    (2) A violation has occurred.
    (c) Rejection of the QIO recommendation. If the OIG decides that a 
sanction is not warranted, it will notify the QIO that recommended the 
sanction, the affected practitioner or other person, and the licensing 
board informed by the QIO of the sanction recommendation that the 
recommendation is rejected.
    (d) Decision to sanction. If the OIG decides that a violation of 
obligations has occurred, it will determine the appropriate sanction by 
considering--
    (1) The recommendation of the QIO;
    (2) The type of offense;
    (3) The severity of the offense;
    (4) The previous sanction record of the practitioner or other 
person;

[[Page 1107]]

    (5) The availability of alternative sources of services in the 
community;
    (6) Any prior problems the Medicare or State health care programs 
have had with the practitioner or other person; and
    (7) Any other matters relevant to the particular case.
    (e) Exclusion sanction. If the QIO submits a recommendation for 
exclusion to the OIG, and a determination is not made by the 120th day 
after actual receipt by the OIG, the exclusion sanction recommended will 
become effective and the OIG will provide notice in accordance with 
Sec. 1004.110(f).
    (f) Monetary penalty. If the QIO recommendation is to assess a 
monetary penalty, the 120-day provision does not apply and the OIG will 
provide notice in accordance with Sec. 1004.110 (a)-(e).

[60 FR 63640, Dec. 12, 1995, as amended at 62 FR 23143, Apr. 29, 1997]



Sec. 1004.110  Notice of sanction.

    (a) The OIG must notify the practitioner or other person of the 
adverse determination and of the sanction to be imposed.
    (b) The sanction is effective 20 days from the date of the notice. 
Receipt is presumed to be 5 days after the date on the notice, unless 
there is a reasonable showing to the contrary.
    (c) The notice must specify--
    (1) The legal and factual basis for the determination;
    (2) The sanction to be imposed;
    (3) The effective date and, if appropriate, the duration of the 
exclusion;
    (4) The appeal rights of the practitioner or other person;
    (5) The opportunity and the process necessary to provide alternative 
notification as set forth in paragraphs (d) and (e) of this section; and
    (6) In the case of exclusion, the earliest date on which the OIG 
will accept a request for reinstatement.
    (d) Patient notification. (1)(i) The OIG will provide a sanctioned 
practitioner or other person an opportunity to elect to inform each of 
their patients of the sanction action. In order to elect this option, 
the sanctioned practitioner or other person must, within 30 calendar 
days from receipt of the OIG notice, inform both new and existing 
patients through written notice--based on a suggested (non-mandatory) 
model provided to the sanctioned individual by the OIG--of the sanction 
and, in the case of an exclusion, its effective date. Receipt of the OIG 
notice is presumed to be 5 days after the date of the notice, unless 
there is a reasonable showing to the contrary. Within this same period, 
the practitioner or other person must also sign and return the 
certification that the OIG will provide with the notice. For purposes of 
this section, the term ``all existing patients'' includes all patients 
currently under active treatment with the practitioner or other person, 
as well as all patients who have been treated by the practitioner or 
other person within the last 3 years. In addition, the practitioner or 
other person must notify all prospective patients orally at the time 
such persons request an appointment. If the sanctioned party is a 
hospital, it must notify all physicians who have privileges at the 
hospital, and must post a notice in its emergency room, business office 
and in all affiliated entities regarding the exclusion. In addition, for 
purposes of this section, the term ``in all affiliated entities'' 
encompasses all entities and properties in which the hospital has a 
direct or indirect ownership interest of 5 percent or more and any 
management, partnership or control of the entity.
    (ii) The certification will provide that the practitioner or other 
person--
    (A) Has informed each of his, her or its patients in writing that 
the practitioner or other person has been sanctioned, or if a hospital, 
has informed all physicians having privileges at the hospital that it 
has been sanctioned;
    (B) If excluded from Medicare and the State health care programs, 
has informed his, her or its existing patients in writing that the 
programs will not pay for items and services furnished or ordered (or at 
the medical direction or on the prescription of an excluded physician) 
by the practitioner or other person until they are reinstated, or if a 
hospital, has provided this information to all physicians having 
privileges at that hospital;
    (C) If excluded from Medicare and State health care programs, will 
provide prospective patients--or if a hospital, physicians requesting 
privileges

[[Page 1108]]

at that hospital prior to furnishing or ordering (or in the case of an 
excluded physician, medically directing or prescribing) services--oral 
information of both the sanction and that the programs will not pay for 
services provided and written notification of the same at the time of 
the provision of services;
    (D) If excluded from Medicare and State health care programs and is 
an entity such as a hospital, has posted a notice in its emergency room, 
business office and in all affiliated entities that the programs will 
not pay for services provided; and
    (E) Certifies to the truthfulness and accuracy of the notification 
and the statements in the certification.
    (2) If the sanctioned practitioner or other person does not inform 
his, her or its patients and does not return the required certification 
within the 30-day period, or if the sanctioned practitioner or other 
person returns the certification within the 30-day period but the OIG 
obtains reliable evidence that such person nevertheless has not 
adequately informed new and existing patients of the sanction, the OIG--
    (i) Will see that the public is notified directly of the identity of 
the sanctioned practitioner or other person, the finding that the 
obligation has been violated, and the effective date of any exclusion; 
and
    (ii) May consider this failure to adhere to the certification 
obligation as an adverse factor at the time the sanctioned practitioner 
or other person requests reinstatement.
    (3) If the sanctioned practitioner or other person is entitled to a 
preliminary hearing in accordance with Sec. 1004.140(a) and requests 
such a preliminary hearing, and if the administrative law judge (ALJ) 
decides that he, she or it poses a risk to program beneficiaries, the 
sanctioned practitioner or other person would have 30 days from the date 
of receipt of the ALJ's decision to provide certification to the OIG in 
accordance with Sec. 1004.110(d)(1). The date of receipt is presumed to 
be 5 days after the date of the ALJ's decision, unless there is a 
reasonable showing to the contrary.
    (e) Notice of the sanction is also provided to the following 
entities as appropriate--
    (1) The QIO that originated the sanction report;
    (2) QIOs in adjacent areas;
    (3) State Medicaid fraud control units and State licensing and 
accreditation bodies;
    (4) Appropriate program contractors and State agencies;
    (5) Hospitals, including the hospital where the sanctioned 
individual's case originated and where the individual currently has 
privileges, if known; skilled nursing facilities, home health agencies, 
and health maintenance organizations and Federally-funded community 
health centers where the practitioner or other person works;
    (6) Medical societies and other professional organizations; and
    (7) Medicare carriers and fiscal intermediaries, health care 
prepayment plans and other affected agencies and organizations.
    (f) If an exclusion sanction is effectuated because a decision was 
not made within 120 days after receipt of the QIO recommendation, 
notification is as follows--
    (1) As soon as possible after the 120th day, the OIG will issue a 
notice to the practitioner or other person, in compliance with the 
requirements of paragraph (c) of this section, affirming the QIO 
recommendation based on the OIG's review of the case, and that the 
exclusion is effective 20 days from the date of the notice; and
    (2) Notice of sanction is also provided as specified in paragraph 
(e) of this section.

[60 FR 63640, Dec. 12, 1995; 61 FR 1841, Jan. 24, 1996, as amended at 62 
FR 23143, Apr. 29, 1997]



               Subpart E_Effect and Duration of Exclusion



Sec. 1004.120  Effect of an exclusion on program payments and services.

    The effect of an exclusion is set forth in Sec. 1001.1901 of this 
chapter.



Sec. 1004.130  Reinstatement after exclusion.

    (a) A practitioner or other person who has been excluded in 
accordance

[[Page 1109]]

with this part may apply for reinstatement at the end of the period of 
exclusion. The OIG will consider any request for reinstatement in 
accordance with provisions of Sec. Sec. 1001.3001 through 1001.3005 of 
this chapter.
    (b) The OIG may also consider a practitioner's or other person's 
compliance with the certification obligation in Sec. 1004.110(d) at the 
time of reinstatement.



                            Subpart F_Appeals



Sec. 1004.140  Appeal rights.

    (a) Right to preliminary hearing. (1)(i) A practitioner or other 
person excluded from participation in Medicare and any State health care 
programs under section 1156 of the Act may request a preliminary hearing 
if the location where services are rendered to over 50 percent of the 
practitioner's or other person's patients at the time of the exclusion 
notice is in a rural HPSA or in a county with a population of less than 
70,000.
    (ii) Unless the practitioner's or other person's practice meets the 
definition for psychiatric professional, vision care professional, 
dental professional, podiatric professional or pharmacy professional, 
the HPSA used by the OIG for determination of entitlement to a 
preliminary hearing will be the HPSA list for primary medical care 
professional.
    (iii) Information on the population size of a county in order to 
determine entitlement to a preliminary hearing will be obtained by the 
OIG from the responsible officials of that county.
    (2)(i) A request for a preliminary hearing must be made in writing 
and received by the Departmental Appeals Board (DAB) no later than the 
15th day after the notice of exclusion is received by a practitioner or 
other person. The date of receipt of the notice of exclusion by the 
practitioner or other person is presumed to be 5 days after the date 
appearing on the notice, unless there is a reasonable showing to the 
contrary.
    (ii) A request for a preliminary hearing will stay the effective 
date of the exclusion pending a decision of the ALJ at the preliminary 
hearing, and all the parties informed by the OIG of the exclusion will 
be notified of the stay.
    (iii) A request for a preliminary hearing received after the 15-day 
period has expired will be treated as a request for a hearing before an 
ALJ in accordance with paragraph (b) of this section.
    (iv) If the practitioner or other person exercises his, her or its 
right to a preliminary hearing, such a hearing must be held by the ALJ 
in accordance with paragraph (a)(3)(i) of this section unless the OIG 
waives it in accordance with paragraph (a)(6)(i) of this section.
    (v) The ALJ cannot consolidate the preliminary hearing with a full 
hearing without the approval of all parties to the hearing.
    (3)(i) The preliminary hearing will be conducted by an ALJ of the 
DAB in a city that the ALJ deems equitable to all parties. The ALJ will 
conduct the preliminary hearing and render a decision no later than 45 
days after receipt of the request for such a hearing by the DAB. Unless 
there is a reasonable showing to the contrary, date of receipt by the 
DAB is presumed to be 5 days after the date on the request for a 
preliminary hearing or, if undated, the date of receipt will be the date 
the DAB actually received the request. A reasonable extension to the 45-
day period of up to 15 days may be requested by any party to the 
preliminary hearing and such a request may be granted upon concurrence 
by all parties to the preliminary hearing. Such request must be received 
no later than 15 days prior to the scheduled date of the preliminary 
hearing.
    (ii) The only issue to be heard and decided on by the ALJ at the 
preliminary hearing, based on the preponderance of the evidence, is 
whether the practitioner's or other person's continued participation in 
the Medicare and State health care programs during the appeal of the 
exclusion before an ALJ would place program beneficiaries at serious 
risk. The ALJ's decision is to be based on the preponderance of the 
evidence.
    (iii) In the interest of time, the ALJ may issue an oral decision to 
be followed by a written decision.
    (iv) In those cases where the ALJ has stayed an exclusion after a 
preliminary hearing, a full hearing must be held

[[Page 1110]]

and a decision rendered by the ALJ within 6 months. If, for any reason, 
the request for a full hearing before the ALJ is withdrawn or dismissed, 
the practitioner or other person will be excluded effective 5 days after 
the notice of the withdrawal or dismissal is received in the OIG 
headquarters.
    (4) The preliminary hearing decision is not appealable or subject to 
further administrative or judicial review.
    (5) A practitioner or other person found at the preliminary hearing 
not to place program beneficiaries at serious risk, but later determined 
to have been properly excluded from program participation after a full 
hearing before an ALJ, is not entitled to have the exclusion stayed 
further during an appeal to the DAB. Exclusions in such instances will 
be effective 5 days after receipt of the ALJ decision in the OIG 
headquarters.
    (6)(i) After notice of a timely request for a preliminary hearing, 
the OIG may determine that the practitioner's or other person's 
continued program participation during the appeal before the ALJ will 
not place program beneficiaries at serious risk and waive the 
preliminary hearing. Under these circumstances, the exclusion will be 
stayed pending the decision of the ALJ after a full hearing. the hearing 
must be held, and a decision reached, within 6 months.
    (ii) If the OIG decides to waive the preliminary hearing, the 
request for the preliminary hearing will be considered a request for a 
hearing before the ALJ in accordance with paragraph (b) of this section.
    (b) Right to administrative review. (1) A practitioner or other 
person dissatisfied with an OIG determination, or an exclusion that 
results from a determination not being made within 120 days, is entitled 
to appeal such sanction in accordance with part 1005 of this chapter.
    (2) Due to the 120-day statutory requirement specified in Sec. 
1004.100(e), the following limitations apply--
    (i) The period of time for submitting additional information will 
not be extended.
    (ii) Any material received by the OIG after the 30-day period 
allowed will not be considered by the ALJ or the DAB.
    (3) The OIG's determination continues in effect unless reversed by a 
hearing.
    (c) Rights to judicial review. Any practitioner or other person 
dissatisfied with a final decision of the Secretary may file a civil 
action in accordance with the provisions of section 205(g) of the Act.



PART 1005_APPEALS OF EXCLUSIONS, CIVIL MONEY PENALTIES AND ASSESSMENTS
--Table of Contents



Sec.
1005.1 Definitions.
1005.2 Hearing before an administrative law judge.
1005.3 Rights of parties.
1005.4 Authority of the ALJ.
1005.5 Ex parte contacts.
1005.6 Prehearing conferences.
1005.7 Discovery.
1005.8 Exchange of witness lists, witness statements and exhibits.
1005.9 Subpoenas for attendance at hearing.
1005.10 Fees.
1005.11 Form, filing and service of papers.
1005.12 Computation of time.
1005.13 Motions.
1005.14 Sanctions.
1005.15 The hearing and burden of proof.
1005.16 Witnesses.
1005.17 Evidence.
1005.18 The record.
1005.19 Post-hearing briefs.
1005.20 Initial decision.
1005.21 Appeal to DAB.
1005.22 Stay of initial decision.
1005.23 Harmless error.

    Authority: 42 U.S.C. 405(a), 405(b), 1302, 1320a-7, 1320a-7a and 
1320c-5.

    Source: 57 FR 3350, Jan. 29, 1992, unless otherwise noted.



Sec. 1005.1  Definitions.

    Civil money penalty cases refer to all proceedings arising under any 
of the statutory bases for which the OIG has been delegated authority to 
impose civil money penalties under Medicare or the State health care 
programs.
    DAB refers to the Departmental Appeals Board or its delegatee.
    Exclusion cases refer to all proceedings arising under any of the 
statutory bases for which the OIG has been delegated authority to impose 
exclusions under Medicare or the State health care programs.

[[Page 1111]]

    Inspector General (IG) means the Inspector General of the Department 
of Health and Human Services or his or her designees.

[57 FR 3350, Jan. 29, 1992, as amended at 65 FR 24418, Apr. 26, 2000]



Sec. 1005.2  Hearing before an administrative law judge.

    (a) A party sanctioned under any criteria specified in parts 1001, 
1003 and 1004 of this chapter may request a hearing before an ALJ.
    (b) In exclusion cases, the parties to the proceeding will consist 
of the petitioner and the IG. In civil money penalty cases, the parties 
to the proceeding will consist of the respondent and the IG.
    (c) The request for a hearing will be made in writing to the DAB; 
signed by the petitioner or respondent, or by his or her attorney; and 
sent by certified mail. The request must be filed within 60 days after 
the notice, provided in accordance with Sec. 1001.2002, Sec. 1001.203 
or Sec. 1003.109, is received by the petitioner or respondent. For 
purposes of this section, the date of receipt of the notice letter will 
be presumed to be 5 days after the date of such notice unless there is a 
reasonable showing to the contrary.
    (d) The request for a hearing will contain a statement as to the 
specific issues or findings of fact and conclusions of law in the notice 
letter with which the petitioner or respondent disagrees, and the basis 
for his or her contention that the specific issues or findings and 
conclusions were incorrect.
    (e) The ALJ will dismiss a hearing request where--
    (1) The petitioner's or the respondent's hearing request is not 
filed in a timely manner;
    (2) The petitioner or respondent withdraws his or her request for a 
hearing;
    (3) The petitioner or respondent abandons his or her request for a 
hearing; or
    (4) The petitioner's or respondent's hearing request fails to raise 
any issue which may properly be addressed in a hearing.

[57 FR 3350, Jan. 29, 1992, as amended at 65 FR 24418, Apr. 26, 2000]



Sec. 1005.3  Rights of parties.

    (a) Except as otherwise limited by this part, all parties may--
    (1) Be accompanied, represented and advised by an attorney;
    (2) Participate in any conference held by the ALJ;
    (3) Conduct discovery of documents as permitted by this part;
    (4) Agree to stipulations of fact or law which will be made part of 
the record;
    (5) Present evidence relevant to the issues at the hearing;
    (6) Present and cross-examine witnesses;
    (7) Present oral arguments at the hearing as permitted by the ALJ; 
and
    (8) Submit written briefs and proposed findings of fact and 
conclusions of law after the hearing.
    (b) Fees for any services performed on behalf of a party by an 
attorney are not subject to the provisions of section 206 of title II of 
the Act, which authorizes the Secretary to specify or limit these fees.



Sec. 1005.4  Authority of the ALJ.

    (a) The ALJ will conduct a fair and impartial hearing, avoid delay, 
maintain order and assure that a record of the proceeding is made.
    (b) The ALJ has the authority to--
    (1) Set and change the date, time and place of the hearing upon 
reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences to identify or simplify the issues, or to 
consider other matters that may aid in the expeditious disposition of 
the proceeding;
    (4) Administer oaths and affirmations;
    (5) Issue subpoenas requiring the attendance of witnesses at 
hearings and the production of documents at or in relation to hearings;
    (6) Rule on motions and other procedural matters;
    (7) Regulate the scope and timing of documentary discovery as 
permitted by this part;
    (8) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;
    (9) Examine witnesses;

[[Page 1112]]

    (10) Receive, rule on, exclude or limit evidence;
    (11) Upon motion of a party, take official notice of facts;
    (12) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact; and
    (13) Conduct any conference, argument or hearing in person or, upon 
agreement of the parties, by telephone.
    (c) The ALJ does not have the authority to--
    (1) Find invalid or refuse to follow Federal statutes or regulations 
or secretarial delegations of authority;
    (2) Enter an order in the nature of a directed verdict;
    (3) Compel settlement negotiations;
    (4) Enjoin any act of the Secretary;
    (5) Review the exercise of discretion by the OIG to exclude an 
individual or entity under section 1128(b) of the Act or under part 1003 
of this chapter, or determine the scope or effect of the exclusion;
    (6) Set a period of exclusion at zero, or reduce a period of 
exclusion to zero, in any case in which the ALJ finds that an individual 
or entity committed an act described in section 1128(b) of the Act or 
under part 1003 of this chapter; or
    (7) Review the exercise of discretion by the OIG to impose a CMP, 
assessment or exclusion under part 1003 of this chapter.

[57 FR 3350, Jan. 29, 1992, as amended at 58 FR 5618, Jan. 22, 1993; 81 
FR 88365, Dec. 7, 2016]



Sec. 1005.5  Ex parte contacts.

    No party or person (except employees of the ALJ's office) will 
communicate in any way with the ALJ on any matter at issue in a case, 
unless on notice and opportunity for all parties to participate. This 
provision does not prohibit a person or party from inquiring about the 
status of a case or asking routine questions concerning administrative 
functions or procedures.



Sec. 1005.6  Prehearing conferences.

    (a) The ALJ will schedule at least one prehearing conference, and 
may schedule additional prehearing conferences as appropriate, upon 
reasonable notice to the parties.
    (b) The ALJ may use prehearing conferences to discuss the 
following--
    (1) Simplification of the issues;
    (2) The necessity or desirability of amendments to the pleadings, 
including the need for a more definite statement;
    (3) Stipulations and admissions of fact or as to the contents and 
authenticity of documents;
    (4) Whether the parties can agree to submission of the case on a 
stipulated record;
    (5) Whether a party chooses to waive appearance at an oral hearing 
and to submit only documentary evidence (subject to the objection of 
other parties) and written argument;
    (6) Limitation of the number of witnesses;
    (7) Scheduling dates for the exchange of witness lists and of 
proposed exhibits;
    (8) Discovery of documents as permitted by this part;
    (9) The time and place for the hearing;
    (10) Such other matters as may tend to encourage the fair, just and 
expeditious disposition of the proceedings; and
    (11) Potential settlement of the case.
    (c) The ALJ will issue an order containing the matters agreed upon 
by the parties or ordered by the ALJ at a prehearing conference.



Sec. 1005.7  Discovery.

    (a) A party may make a request to another party for production of 
documents for inspection and copying which are relevant and material to 
the issues before the ALJ.
    (b) For the purpose of this section, the term documents includes 
information, reports, answers, records, accounts, papers and other data 
and documentary evidence. Nothing contained in this section will be 
interpreted to require the creation of a document, except that requested 
data stored in an electronic data storage system will be produced in a 
form accessible to the requesting party.
    (c) Requests for documents, requests for admissions, written 
interrogatories, depositions and any forms of discovery,

[[Page 1113]]

other than those permitted under paragraph (a) of this section, are not 
authorized.
    (d) This section will not be construed to require the disclosure of 
interview reports or statements obtained by any party, or on behalf of 
any party, of persons who will not be called as witnesses by that party, 
or analyses and summaries prepared in conjunction with the investigation 
or litigation of the case, or any otherwise privileged documents.
    (e)(1) When a request for production of documents has been received, 
within 30 days the party receiving that request will either fully 
respond to the request, or state that the request is being objected to 
and the reasons for that objection. If objection is made to part of an 
item or category, the part will be specified. Upon receiving any 
objections, the party seeking production may then, within 30 days or any 
other time frame set by the ALJ, file a motion for an order compelling 
discovery. (The party receiving a request for production may also file a 
motion for protective order any time prior to the date the production is 
due.)
    (2) The ALJ may grant a motion for protective order or deny a motion 
for an order compelling discovery if the ALJ finds that the discovery 
sought--
    (i) Is irrelevant,
    (ii) Is unduly costly or burdensome,
    (iii) Will unduly delay the proceeding, or
    (iv) Seeks privileged information.
    (3) The ALJ may extend any of the time frames set forth in paragraph 
(e)(1) of this section.
    (4) The burden of showing that discovery should be allowed is on the 
party seeking discovery.

[57 FR 3350, Jan. 29, 1992, as amended at 58 FR 5618, Jan. 22, 1993; 65 
FR 24418, Apr. 26, 2000; 65 FR 35584, June 5, 2000; 67 FR 11936, Mar. 
18, 2002]



Sec. 1005.8  Exchange of witness lists, witness statements and exhibits.

    (a) At least 15 days before the hearing, the ALJ will order the 
parties to exchange witness lists, copies of prior written statements of 
proposed witnesses and copies of proposed hearing exhibits, including 
copies of any written statements that the party intends to offer in lieu 
of live testimony in accordance with Sec. 1005.16.
    (b)(1) If at any time a party objects to the proposed admission of 
evidence not exchanged in accordance with paragraph (a) of this section, 
the ALJ will determine whether the failure to comply with paragraph (a) 
of this section should result in the exclusion of such evidence.
    (2) Unless the ALJ finds that extraordinary circumstances justified 
the failure to timely exchange the information listed under paragraph 
(a) of this section, the ALJ must exclude from the party's case-in-
chief:
    (i) The testimony of any witness whose name does not appear on the 
witness list, and
    (ii) Any exhibit not provided to the opposing party as specified in 
paragraph (a) of this section.
    (3) If the ALJ finds that extraordinary circumstances existed, the 
ALJ must then determine whether the admission of such evidence would 
cause substantial prejudice to the objecting party. If the ALJ finds 
that there is no substantial prejudice, the evidence may be admitted. If 
the ALJ finds that there is substantial prejudice, the ALJ may exclude 
the evidence, or at his or her discretion, may postpone the hearing for 
such time as is necessary for the objecting party to prepare and respond 
to the evidence.
    (c) Unless another party objects within a reasonable period of time 
prior to the hearing, documents exchanged in accordance with paragraph 
(a) of this section will be deemed to be authentic for the purpose of 
admissibility at the hearing.



Sec. 1005.9  Subpoenas for attendance at hearing.

    (a) A party wishing to procure the appearance and testimony of any 
individual at the hearing may make a motion requesting the ALJ to issue 
a subpoena if the appearance and testimony are reasonably necessary for 
the presentation of a party's case.
    (b) A subpoena requiring the attendance of an individual in 
accordance with paragraph (a) of this section may also require the 
individual (whether or not the individual is a party) to produce 
evidence authorized under

[[Page 1114]]

Sec. 1005.7 of this part at or prior to the hearing.
    (c) When a subpoena is served by a respondent or petitioner on a 
particular individual or particular office of the OIG, the OIG may 
comply by designating any of its representatives to appear and testify.
    (d) A party seeking a subpoena will file a written motion not less 
than 30 days before the date fixed for the hearing, unless otherwise 
allowed by the ALJ for good cause shown. Such request will:
    (1) Specify any evidence to be produced,
    (2) Designate the witnesses, and
    (3) Describe the address and location with sufficient particularity 
to permit such witnesses to be found.
    (e) The subpoena will specify the time and place at which the 
witness is to appear and any evidence the witness is to produce.
    (f) Within 15 days after the written motion requesting issuance of a 
subpoena is served, any party may file an opposition or other response.
    (g) If the motion requesting issuance of a subpoena is granted, the 
party seeking the subpoena will serve it by delivery to the individual 
named, or by certified mail addressed to such individual at his or her 
last dwelling place or principal place of business.
    (h) The individual to whom the subpoena is directed may file with 
the ALJ a motion to quash the subpoena within 10 days after service.
    (i) The exclusive remedy for contumacy by, or refusal to obey a 
subpoena duly served upon, any person is specified in section 205(e) of 
the Social Security Act (42 U.S.C. 405(e)).

[57 FR 3350, Jan. 29, 1992, as amended at 65 FR 24418, Apr. 26, 2000]



Sec. 1005.10  Fees.

    The party requesting a subpoena will pay the cost of the fees and 
mileage of any witness subpoenaed in the amounts that would be payable 
to a witness in a proceeding in United States District Court. A check 
for witness fees and mileage will accompany the subpoena when served, 
except that when a subpoena is issued on behalf of the IG, a check for 
witness fees and mileage need not accompany the subpoena.



Sec. 1005.11  Form, filing and service of papers.

    (a) Forms. (1) Unless the ALJ directs the parties to do otherwise, 
documents filed with the ALJ will include an original and two copies.
    (2) Every pleading and paper filed in the proceeding will contain a 
caption setting forth the title of the action, the case number, and a 
designation of the paper, such as motion to quash subpoena.
    (3) Every pleading and paper will be signed by, and will contain the 
address and telephone number of the party or the person on whose behalf 
the paper was filed, or his or her representative.
    (4) Papers are considered filed when they are mailed.
    (b) Service. A party filing a document with the ALJ or the Secretary 
will, at the time of filing, serve a copy of such document on every 
other party. Service upon any party of any document will be made by 
delivering a copy, or placing a copy of the document in the United 
States mail, postage prepaid and addressed, or with a private delivery 
service, to the party's last known address. When a party is represented 
by an attorney, service will be made upon such attorney in lieu of the 
party.
    (c) Proof of service. A certificate of the individual serving the 
document by personal delivery or by mail, setting forth the manner of 
service, will be proof of service.



Sec. 1005.12  Computation of time.

    (a) In computing any period of time under this part or in an order 
issued thereunder, the time begins with the day following the act, event 
or default, and includes the last day of the period unless it is a 
Saturday, Sunday or legal holiday observed by the Federal Government, in 
which event it includes the next business day.
    (b) When the period of time allowed is less than 7 days, 
intermediate Saturdays, Sundays and legal holidays observed by the 
Federal Government will be excluded from the computation.
    (c) Where a document has been served or issued by placing it in the 
mail, an additional 5 days will be added to the time permitted for any 
response. This paragraph does not apply to requests for hearing under 
Sec. 1005.2.

[[Page 1115]]



Sec. 1005.13  Motions.

    (a) An application to the ALJ for an order or ruling will be by 
motion. Motions will state the relief sought, the authority relied upon 
and the facts alleged, and will be filed with the ALJ and served on all 
other parties.
    (b) Except for motions made during a prehearing conference or at the 
hearing, all motions will be in writing. The ALJ may require that oral 
motions be reduced to writing.
    (c) Within 10 days after a written motion is served, or such other 
time as may be fixed by the ALJ, any party may file a response to such 
motion.
    (d) The ALJ may not grant a written motion before the time for 
filing responses has expired, except upon consent of the parties or 
following a hearing on the motion, but may overrule or deny such motion 
without awaiting a response.
    (e) The ALJ will make a reasonable effort to dispose of all 
outstanding motions prior to the beginning of the hearing.



Sec. 1005.14  Sanctions.

    (a) The ALJ may sanction a person, including any party or attorney, 
for failing to comply with an order or procedure, for failing to defend 
an action or for other misconduct that interferes with the speedy, 
orderly or fair conduct of the hearing. Such sanctions will reasonably 
relate to the severity and nature of the failure or misconduct. Such 
sanction may include--
    (1) In the case of refusal to provide or permit discovery under the 
terms of this part, drawing negative factual inferences or treating such 
refusal as an admission by deeming the matter, or certain facts, to be 
established;
    (2) Prohibiting a party from introducing certain evidence or 
otherwise supporting a particular claim or defense;
    (3) Striking pleadings, in whole or in part;
    (4) Staying the proceedings;
    (5) Dismissal of the action;
    (6) Entering a decision by default; and
    (7) Refusing to consider any motion or other action that is not 
filed in a timely manner.
    (b) In civil money penalty cases commenced under section 1128A of 
the Act or under any provision which incorporates section 1128A(c)(4) of 
the Act, the ALJ may also order the party or attorney who has engaged in 
any of the acts described in paragraph (a) of this section to pay 
attorney's fees and other costs caused by the failure or misconduct.



Sec. 1005.15  The hearing and burden of proof.

    (a) The ALJ will conduct a hearing on the record in order to 
determine whether the petitioner or respondent should be found liable 
under this part.
    (b) With regard to the burden of proof in civil money penalty cases 
under part 1003, in Quality Improvement Organization exclusion cases 
under part 1004, and in exclusion cases under Sec. Sec. 1001.701, 
1001.901 and 1001.951 of this chapter--
    (1) The respondent or petitioner, as applicable, bears the burden of 
going forward and the burden of persuasion with respect to affirmative 
defenses and any mitigating circumstances; and
    (2) The IG bears the burden of going forward and the burden of 
persuasion with respect to all other issues.
    (c) Burden of proof in all other exclusion cases. In all exclusion 
cases except those governed by paragraph (b) of this section, the ALJ 
will allocate the burden of proof as the ALJ deems appropriate.
    (d) The burden of persuasion will be judged by a preponderance of 
the evidence.
    (e) The hearing will be open to the public unless otherwise ordered 
by the ALJ for good cause shown.
    (f)(1) A hearing under this part is not limited to specific items 
and information set forth in the notice letter to the petitioner or 
respondent. Subject to the 15-day requirement under Sec. 1005.8, 
additional items and information, including aggravating or mitigating 
circumstances that arose or became known subsequent to the issuance of 
the notice letter, may be introduced by either party during its case-in-
chief unless such information or items are--
    (i) Privileged;

[[Page 1116]]

    (ii) Disqualified from consideration due to untimeliness in 
accordance with Sec. 1004.130(a)(2)(ii); or
    (iii) Deemed otherwise inadmissible under Sec. 1005.17.
    (2) After both parties have presented their cases, evidence may be 
admitted on rebuttal even if not previously exchanged in accordance with 
Sec. 1005.8.

[57 FR 3350, Jan. 29, 1992, as amended at 63 FR 46691, Sept. 2, 1998; 65 
FR 24418, Apr. 26, 2000]



Sec. 1005.16  Witnesses.

    (a) Except as provided in paragraph (b) of this section, testimony 
at the hearing will be given orally by witnesses under oath or 
affirmation.
    (b) At the discretion of the ALJ, testimony (other than expert 
testimony) may be admitted in the form of a written statement. The ALJ 
may, at his or her discretion, admit prior sworn testimony of experts 
which has been subject to adverse examination, such as a deposition or 
trial testimony. Any such written statement must be provided to all 
other parties along with the last known address of such witnesses, in a 
manner that allows sufficient time for other parties to subpoena such 
witness for cross-examination at the hearing. Prior written statements 
of witnesses proposed to testify at the hearing will be exchanged as 
provided in Sec. 1005.8.
    (c) The ALJ will exercise reasonable control over the mode and order 
of interrogating witnesses and presenting evidence so as to:
    (1) Make the interrogation and presentation effective for the 
ascertainment of the truth,
    (2) Avoid repetition or needless consumption of time, and
    (3) Protect witnesses from harassment or undue embarrassment.
    (d) The ALJ will permit the parties to conduct such cross-
examination of witnesses as may be required for a full and true 
disclosure of the facts.
    (e) The ALJ may order witnesses excluded so that they cannot hear 
the testimony of other witnesses. This does not authorize exclusion of--
    (1) A party who is an individual;
    (2) In the case of a party that is not an individual, an officer or 
employee of the party appearing for the entity pro se or designated as 
the party's representative; or
    (3) An individual whose presence is shown by a party to be essential 
to the presentation of its case, including an individual engaged in 
assisting the attorney for the IG.

[57 FR 3350, Jan. 29, 1992, as amended at 67 FR 11936, Mar. 18, 2002]



Sec. 1005.17  Evidence.

    (a) The ALJ will determine the admissibility of evidence.
    (b) Except as provided in this part, the ALJ will not be bound by 
the Federal Rules of Evidence. However, the ALJ may apply the Federal 
Rules of Evidence where appropriate, for example, to exclude unreliable 
evidence.
    (c) The ALJ must exclude irrelevant or immaterial evidence.
    (d) Although relevant, evidence may be excluded if its probative 
value is substantially outweighed by the danger of unfair prejudice, 
confusion of the issues, or by considerations of undue delay or needless 
presentation of cumulative evidence.
    (e) Although relevant, evidence must be excluded if it is privileged 
under Federal law.
    (f) Evidence concerning offers of compromise or settlement made in 
this action will be inadmissible to the extent provided in Rule 408 of 
the Federal Rules of Evidence.
    (g) Evidence of crimes, wrongs or acts other than those at issue in 
the instant case is admissible in order to show motive, opportunity, 
intent, knowledge, preparation, identity, lack of mistake, or existence 
of a scheme. Such evidence is admissible regardless of whether the 
crimes, wrongs or acts occurred during the statute of limitations period 
applicable to the acts which constitute the basis for liability in the 
case, and regardless of whether they were referenced in the IG's notice 
sent in accordance with Sec. 1001.2002, Sec. 1001.2003 or Sec. 
1003.109.
    (h) The ALJ will permit the parties to introduce rebuttal witnesses 
and evidence.
    (i) All documents and other evidence offered or taken for the record 
will be open to examination by all parties, unless otherwise ordered by 
the ALJ for good cause shown.

[[Page 1117]]

    (j) The ALJ may not consider evidence regarding the issue of 
willingness and ability to enter into and successfully complete a 
corrective action plan when such evidence pertains to matters occurring 
after the submittal of the case to the Secretary. The determination 
regarding the appropriateness of any corrective action plan is not 
reviewable.



Sec. 1005.18  The record.

    (a) The hearing will be recorded and transcribed. Transcripts may be 
obtained following the hearing from the ALJ.
    (b) The transcript of testimony, exhibits and other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for the decision by the ALJ and the 
Secretary.
    (c) The record may be inspected and copied (upon payment of a 
reasonable fee) by any person, unless otherwise ordered by the ALJ for 
good cause shown.
    (d) For good cause, the ALJ may order appropriate redactions made to 
the record.



Sec. 1005.19  Post-hearing briefs.

    The ALJ may require the parties to file post-hearing briefs. In any 
event, any party may file a post-hearing brief. The ALJ will fix the 
time for filing such briefs which are not to exceed 60 days from the 
date the parties receive the transcript of the hearing or, if 
applicable, the stipulated record. Such briefs may be accompanied by 
proposed findings of fact and conclusions of law. The ALJ may permit the 
parties to file reply briefs.



Sec. 1005.20  Initial decision.

    (a) The ALJ will issue an initial decision, based only on the 
record, which will contain findings of fact and conclusions of law.
    (b) The ALJ may affirm, increase or reduce the penalties, assessment 
or exclusion proposed or imposed by the IG, or reverse the imposition of 
the exclusion. In exclusion cases where the period of exclusion 
commenced prior to the hearing, any period of exclusion imposed by the 
ALJ will be deemed to commence on the date such exclusion originally 
went into effect.
    (c) The ALJ will issue the initial decision to all parties within 60 
days after the time for submission of post-hearing briefs and reply 
briefs, if permitted, has expired. The decision will be accompanied by a 
statement describing the right of any party to file a notice of appeal 
with the DAB and instructions for how to file such appeal. If the ALJ 
fails to meet the deadline contained in this paragraph, he or she will 
notify the parties of the reason for the delay and will set a new 
deadline.
    (d) Except for exclusion actions taken in accordance with Sec. 
1001.2003 of this chapter and as provided in paragraph (e) of this 
section, unless the initial decision is appealed to the DAB, it will be 
final and binding on the parties 30 days after the ALJ serves the 
parties with a copy of the decision. If service is by mail, the date of 
service will be deemed to be 5 days from the date of mailing.
    (e) If an extension of time within which to appeal the initial 
decision is granted under Sec. 1005.21(a), except as provided in Sec. 
1005.22(a), the initial decision will become final and binding on the 
day following the end of the extension period.

[57 FR 3350, Jan. 29, 1992, as amended at 65 FR 24418, Apr. 26, 2000]



Sec. 1005.21  Appeal to DAB.

    (a) Any party may appeal the initial decision of the ALJ to the DAB 
by filing a notice of appeal with the DAB within 30 days of the date of 
service of the initial decision. The DAB may extend the initial 30 day 
period for a period of time not to exceed 30 days if a party files with 
the DAB a request for an extension within the initial 30 day period and 
shows good cause.
    (b) If a party files a timely notice of appeal with the DAB, the ALJ 
will forward the record of the proceeding to the DAB.
    (c) A notice of appeal will be accompanied by a written brief 
specifying exceptions to the initial decision and reasons supporting the 
exceptions. Any party may file a brief in opposition to exceptions, 
which may raise any relevant issue not addressed in the exceptions, 
within 30 days of receiving the notice of appeal and accompanying

[[Page 1118]]

brief. The DAB may permit the parties to file reply briefs.
    (d) There is no right to appear personally before the DAB or to 
appeal to the DAB any interlocutory ruling by the ALJ, except on the 
timeliness of a filing of the hearing request.
    (e) The DAB will not consider any issue not raised in the parties' 
briefs, nor any issue in the briefs that could have been raised before 
the ALJ but was not.
    (f) If any party demonstrates to the satisfaction of the DAB that 
additional evidence not presented at such hearing is relevant and 
material and that there were reasonable grounds for the failure to 
adduce such evidence at such hearing, the DAB may remand the matter to 
the ALJ for consideration of such additional evidence.
    (g) The DAB may decline to review the case, or may affirm, increase, 
reduce, reverse or remand any penalty, assessment or exclusion 
determined by the ALJ.
    (h) The standard of review on a disputed issue of fact is whether 
the initial decision is supported by substantial evidence on the whole 
record. The standard of review on a disputed issue of law is whether the 
initial decision is erroneous.
    (i) Within 60 days after the time for submission of briefs and reply 
briefs, if permitted, has expired, the DAB will issue to each party to 
the appeal a copy of the DAB's decision and a statement describing the 
right of any petitioner or respondent who is found liable to seek 
judicial review.
    (j) Except with respect to any penalty, assessment or exclusion 
remanded by the ALJ, the DAB's decision, including a decision to decline 
review of the initial decision, becomes final and binding 60 days after 
the date on which the DAB serves the parties with a copy of the 
decision. If service is by mail, the date of service will be deemed to 
be 5 days from the date of mailing.
    (k) (1) Any petition for judicial review must be filed within 60 
days after the DAB serves the parties with a copy of the decision. If 
service is by mail, the date of service will be deemed to be 5 days from 
the date of mailing.
    (2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for 
judicial review filed in any U.S. Court of Appeals challenging a final 
action of the DAB will be sent by certified mail, return receipt 
requested, to the Chief Counsel to the IG. The petition copy will be 
time-stamped by the clerk of the court when the original is filed with 
the court.
    (3) If the Chief Counsel to the IG receives two or more petitions 
within 10 days after the DAB issues its decision, the Chief Counsel to 
the IG will notify the U.S. Judicial Panel on Multidistrict Litigation 
of any petitions that were received within the 10-day period.

[57 FR 3350, Jan. 29, 1992, as amended at 63 FR 46691, Sept. 2, 1998; 65 
FR 24419, Apr. 26, 2000]



Sec. 1005.22  Stay of initial decision.

    (a) In a CMP case under section 1128A of the Act, the filing of a 
respondent's request for review by the DAB will automatically stay the 
effective date of the ALJ's decision.
    (b) (1) After the DAB renders a decision in a CMP case, pending 
judicial review, the respondent may file a request for stay of the 
effective date of any penalty or assessment with the ALJ. The request 
must be accompanied by a copy of the notice of appeal filed with the 
Federal court. The filing of such a request will automatically act to 
stay the effective date of the penalty or assessment until such time as 
the ALJ rules upon the request.
    (2) The ALJ may not grant a respondent's request for stay of any 
penalty or assessment unless the respondent posts a bond or provides 
other adequate security.
    (3) The ALJ will rule upon a respondent's request for stay within 10 
days of receipt.



Sec. 1005.23  Harmless error.

    No error in either the admission or the exclusion of evidence, and 
no error or defect in any ruling or order or in any act done or omitted 
by the ALJ or by any of the parties, including Federal representatives 
such as Medicare carriers and intermediaries and Quality Improvement 
Organizations, is ground for vacating, modifying or otherwise disturbing 
an otherwise appropriate ruling or order or act, unless refusal to take 
such action appears to the ALJ or

[[Page 1119]]

the DAB inconsistent with substantial justice. The ALJ and the DAB at 
every stage of the proceeding will disregard any error or defect in the 
proceeding that does not affect the substantial rights of the parties.



PART 1006_INVESTIGATIONAL INQUIRIES--Table of Contents



Sec.
1006.1 Scope.
1006.2 Contents of subpoena.
1006.3 Service and fees.
1006.4 Procedures for investigational inquiries.
1006.5 Enforcement of a subpoena.

    Authority: 42 U.S.C. 405(d), 405(e), 1302, 1320a-7, and 1320a-7a.

    Source: 57 FR 3354, Jan. 29, 1992, unless otherwise noted.



Sec. 1006.1  Scope.

    (a) The provisions in this part govern subpoenas issued by the 
Inspector General, or his or her delegates, in accordance with sections 
205(d), 1128A(j), and 1128(f)(4) of the Act and require the attendance 
and testimony of witnesses and the production of any other evidence at 
an investigational inquiry.
    (b) Such subpoenas may be issued in investigations under section 
1128 or 1128A of the Act or under any other section of the Act that 
incorporates the provisions of sections 1128(f)(4) or 1128A(j).
    (c) Nothing in this part is intended to apply to or limit the 
authority of the Inspector General, or his or her delegates, to issue 
subpoenas for the production of documents in accordance with 5 U.S.C. 
6(a)(4), App. 3.

[57 FR 3354, Jan. 29, 1992, as amended at 82 FR 4118, Jan. 12, 2017]



Sec. 1006.2  Contents of subpoena.

    A subpoena issued under this part will--
    (a) State the name of the individual or entity to whom the subpoena 
is addressed;
    (b) State the statutory authority for the subpoena;
    (c) Indicate the date, time and place that the investigational 
inquiry at which the witness is to testify will take place;
    (d) Include a reasonably specific description of any documents or 
items required to be produced; and
    (e) If the subpoena is addressed to an entity, describe with 
reasonable particularity the subject matter on which testimony is 
required. In such event, the named entity will designate one or more 
individuals who will testify on its behalf, and will state as to each 
individual so designated that individual's name and address and the 
matters on which he or she will testify. The individual so designated 
will testify as to matters known or reasonably available to the entity.



Sec. 1006.3  Service and fees.

    (a) A subpoena under this part will be served by--
    (1) Delivering a copy to the individual named in the subpoena;
    (2) Delivering a copy to the entity named in the subpoena at its 
last principal place of business; or
    (3) Registered or certified mail addressed to such individual or 
entity at its last known dwelling place or principal place of business.
    (b) A verified return by the individual serving the subpoena setting 
forth the manner of service or, in the case of service by registered or 
certified mail, the signed return post office receipt, will be proof of 
service.
    (c) Witnesses will be entitled to the same fees and mileage as 
witnesses in the district courts of the United States (28 U.S.C. 1821 
and 1825). Such fees need not be paid at the time the subpoena is 
served.



Sec. 1006.4  Procedures for investigational inquiries.

    (a) Testimony at investigational inquiries will be taken under oath 
or affirmation.
    (b) Investigational inquiries are non-public investigatory 
proceedings. Attendance of non-witnesses is within the discretion of the 
OIG, except that--
    (1) A witness is entitled to be accompanied, represented and advised 
by an attorney; and
    (2) Representatives of the OIG are entitled to attend and ask 
questions.
    (c) A witness will have an opportunity to clarify his or her answers 
on

[[Page 1120]]

the record following the questions by the OIG.
    (d) Any claim of privilege must be asserted by the witness on the 
record.
    (e) Objections must be asserted on the record. Errors of any kind 
that might be corrected if promptly presented will be deemed to be 
waived unless reasonable objection is made at the investigational 
inquiry. Except where the objection is on the grounds of privilege, the 
question will be answered on the record, subject to the objection.
    (f) If a witness refuses to answer any question not privileged or to 
produce requested documents or items, or engages in conduct likely to 
delay or obstruct the investigational inquiry, the OIG may seek 
enforcement of the subpoena under Sec. 1006.5.
    (g)(1) The proceedings will be recorded and transcribed.
    (2) The witness is entitled to a copy of the transcript, upon 
payment of prescribed costs, except that, for good cause, the witness 
may be limited to inspection of the official transcript of his or her 
testimony.
    (3)(i) The transcript will be submitted to the witness for 
signature.
    (ii) Where the witness will be provided a copy of the transcript, 
the transcript will be submitted to the witness for signature. The 
witness may submit to the OIG written proposed corrections to the 
transcript, with such corrections attached to the transcript. If the 
witness does not return a signed copy of the transcript or proposed 
corrections within 30 days of its being submitted to him or her for 
signature, the witness will be deemed to have agreed that the transcript 
is true and accurate.
    (iii) Where, as provided in paragraph (g)(2) of this section, the 
witness is limited to inspecting the transcript, the witness will have 
the opportunity at the time of inspection to propose corrections to the 
transcript, with corrections attached to the transcript. The witness 
will also have the opportunity to sign the transcript. If the witness 
does not sign the transcript or offer corrections within 30 days of 
receipt of notice of the opportunity to inspect the transcript, the 
witness will be deemed to have agreed that the transcript is true and 
accurate.
    (iv) The OIG's proposed corrections the record of transcript will be 
attached to the transcript.
    (h) Testimony and other evidence obtained in an investigational 
inquiry may be used by the OIG or DHHS in any of its activities, and may 
be used or offered into evidence in any administrative or judicial 
proceeding.

[57 FR 3354, Jan. 29, 1992, as amended at 65 FR 24419, Apr. 26, 2000]



Sec. 1006.5  Enforcement of a subpoena.

    A subpoena to appear at an investigational inquiry is enforceable 
through the District Court of the United States and the district where 
the subpoenaed person is found, resides or transacts business.



PART 1007_STATE MEDICAID FRAUD CONTROL UNITS--Table of Contents



              Subpart A_General Provisions and Definitions

Sec.
1007.1 Definitions.
1007.3 Statutory basis and organization of rule.

                Subpart B_Requirements for Certification

1007.5 Single, identifiable entity requirements of Unit.
1007.7 Prosecutorial authority requirements of Unit.
1007.9 Relationship and agreement between Unit and Medicaid agency.
1007.11 Duties and responsibilities of Unit.
1007.13 Staffing requirements of Unit.
1007.15 Establishment and certification of Unit.
1007.17 Annual recertification of Unit.

             Subpart C_Federal Financial Participation (FFP)

1007.19 FFP rate and eligible FFP costs.
1007.20 Circumstances of permissible data mining.
1007.21 Disallowance of claims for FFP.

                       Subpart D_Other Provisions

1007.23 Other applicable HHS regulations.

    Authority: 42 U.S.C. 1302, 1396a(a)(61), 1396b(a)(6), 1396b(b)(3), 
and 1396b(q).

    Source: 84 FR 10713, Mar. 22, 2019, unless otherwise noted.

[[Page 1121]]



              Subpart A_General Provisions and Definitions



Sec. 1007.1  Definitions.

    As used in this part, unless otherwise indicated by the context:
    Abuse of patients or residents means any act that constitutes abuse 
of a patient or resident of a health care facility or board and care 
facility under applicable State law. Such conduct may include the 
infliction of injury, unreasonable confinement, intimidation, or 
punishment with resulting physical or financial harm, pain, or mental 
anguish.
    Board and care facility means a residential setting that receives 
payment (regardless of whether such payment is made under Title XIX of 
the Social Security Act) from or on behalf of two or more unrelated 
adults who reside in such facility, and for whom one or both of the 
following is provided:
    (1) Nursing care services provided by, or under the supervision of, 
a registered nurse, licensed practical nurse, or licensed nursing 
assistant.
    (2) A substantial amount of personal care services that assist 
residents with the activities of daily living, including personal 
hygiene, dressing, bathing, eating, toileting, ambulation, transfer, 
positioning, self-medication, body care, travel to medical services, 
essential shopping, meal preparation, laundry, and housework.
    Data mining means the practice of electronically sorting Medicaid or 
other relevant data, including, but not limited to, the use of 
statistical models and intelligent technologies, to uncover patterns and 
relationships within that data to identify aberrant utilization, 
billing, or other practices that are potentially fraudulent.
    Director means a professional employee of the Unit who supervises 
all Unit employees, either directly or through other Unit managers.
    Exclusive effort means that a Unit's professional employees, except 
as otherwise permitted in Sec. 1007.13, dedicate their efforts 
``exclusively'' to the functions and responsibilities of a Unit as 
described in this part. Exclusive effort requires that duty with the 
Unit be intended to last for at least one (1) year and includes an 
arrangement in which an employee is on detail or assignment from another 
government agency, but only if the detail or arrangement is intended to 
last for at least one (1) year.
    Fraud means any act that constitutes criminal or civil fraud under 
applicable State law. Such conduct may include deception, concealment of 
material fact, or misrepresentation made intentionally, in deliberate 
ignorance of the truth, or in reckless disregard of the truth.
    Full-time employee means an employee of the Unit who has full-time 
status as defined by the State.
    Health care facility means a provider that receives payments under 
Medicaid and furnishes food, shelter, and some treatment or services to 
four or more persons unrelated to the proprietor in an inpatient 
setting.
    Misappropriation of patient or resident funds means the wrongful 
taking or use, as defined under applicable State law, of funds or 
property of a patient or resident of a health care facility or board and 
care facility.
    Neglect of patients or residents means any act that constitutes 
neglect of a patient or resident of a health care facility or board and 
care facility under applicable State law. Such conduct may include the 
failure to provide goods and services necessary to avoid physical harm, 
mental anguish, or mental illness.
    Part-time employee means an employee of the Unit who has part-time 
status as defined by the State.
    Professional employee means an investigator, attorney, or auditor.
    Program abuse means provider practices that do not meet the 
definition of civil or criminal fraud under applicable State law, but 
nonetheless are inconsistent with sound fiscal, business, or medical 
practices.
    Provider means:
    (1) An individual or entity that furnishes or arranges for the 
furnishing of items or services for which payment is claimed under 
Medicaid, including an individual or entity in a managed care network;
    (2) An individual or entity that is required to enroll in a State 
Medicaid program, such as an ordering, prescribing, or referring 
physician; or

[[Page 1122]]

    (3) Any individual or entity that may operate as a health care 
provider under applicable State law.
    Unit means State Medicaid Fraud Control Unit.



Sec. 1007.3  Statutory basis and organization of rule.

    (a) Statutory basis. This part codifies sections 1903(a)(6) and 
1903(b)(3) of the Social Security Act (the Act), which establish the 
amounts and conditions of Federal matching payments for expenditures 
incurred in establishing and operating a State MFCU. This part also 
implements section 1903(q) of the Act, which establishes the basic 
requirements and standards that Units must meet to demonstrate that they 
are effectively carrying out the functions of the Unit in order to be 
certified by OIG as eligible for FFP under Title XIX of the Act. Section 
1902(a)(61) of the Act requires a State to provide in its Medicaid State 
plan that it operates a Unit that effectively carries out the functions 
and requirements described in this part, as determined in accordance 
with standards established by OIG, unless the State demonstrates that a 
Unit would not be cost effective because of minimal Medicaid fraud in 
the covered services under the plan and that beneficiaries under the 
plan will be protected from abuse and neglect in connection with the 
provision of medical assistance under the plan without the existence of 
such a Unit. CMS retains the authority to determine a State's compliance 
with Medicaid State plan requirements in accordance with section 1902(a) 
of the Act.
    (b) Organization of this part. Subpart A of this part defines terms 
used in this part and sets forth the statutory basis and organization of 
this part. Subpart B specifies the certification requirements that a 
Unit must meet to be eligible for FFP, including requirements for 
applying and reapplying for certification. Subpart C specifies FFP 
rates, costs eligible and not eligible for FFP, and FFP disallowance 
procedures. Subpart D specifies other HHS regulations applicable to the 
MFCU grants.



                Subpart B_Requirements for Certification



Sec. 1007.5  Single, identifiable entity requirements of Unit.

    (a) A Unit must be a single, identifiable entity of the State 
government.
    (b) To be considered a single, identifiable entity of the State 
government, the Unit must:
    (1) Be a single organization reporting to the Unit director;
    (2) Operate under a budget that is separate from that of its parent 
agency; and
    (3) Have the headquarters office and any field offices each in their 
own contiguous space, unless the Unit demonstrates to OIG that 
circumstances warrant a different arrangement for certain employees.



Sec. 1007.7  Prosecutorial authority requirements of Unit.

    A Unit must be organized according to one of the following three 
options related to a Unit's prosecutorial authority:
    (a) The Unit is in the office of the State Attorney General or 
another department of State government that has statewide authority to 
prosecute individuals for violations of criminal laws with respect to 
fraud and patient or resident abuse or neglect in the provision or 
administration of medical assistance under a State plan implementing 
Title XIX of the Act.
    (b) If there is no State agency with statewide authority and 
capability for criminal fraud or patient or resident abuse or neglect 
prosecutions, the Unit has established formal written procedures 
ensuring that the Unit refers suspected cases of criminal fraud in the 
State Medicaid program or of patient or resident abuse and neglect to 
the appropriate prosecuting authority or authorities, and coordinates 
with and assists such authority or authorities in the prosecution of 
such cases.
    (c) The Unit has a formal working relationship with the office of 
the State Attorney General, or another office with statewide 
prosecutorial authority, and has formal written procedures for referring 
to the State Attorney General or other office suspected criminal

[[Page 1123]]

violations and for effective coordination of the activities of both 
entities relating to the detection, investigation, and prosecution of 
those violations relating to the State Medicaid program. Under this 
working relationship, the office of the State Attorney General, or other 
office, must agree to assume responsibility for prosecuting alleged 
criminal violations referred to it by the Unit. However, if the State 
Attorney General finds that another prosecuting authority has the 
demonstrated capacity, experience, and willingness to prosecute an 
alleged violation, he or she may refer a case to that prosecuting 
authority, as long as the office of the State Attorney General maintains 
oversight responsibility for the prosecution and for coordination 
between the Unit and the prosecuting authority.



Sec. 1007.9  Relationship and agreement between Unit and Medicaid
agency.

    (a) The Unit must be separate and distinct from the Medicaid agency.
    (b) No official of the Medicaid agency will have authority to review 
the activities of the Unit or to review or overrule the referral of a 
suspected criminal violation to an appropriate prosecuting authority.
    (c) The Unit will not receive funds paid under this part either from 
or through the Medicaid agency.
    (d) The Unit must enter into a written agreement with the Medicaid 
agency under which:
    (1) The Medicaid agency will agree to comply with all requirements 
of Sec. 455.21(a) of this title;
    (2) The Unit will agree to comply with the requirements of Sec. 
1007.11(c) of this title; and
    (3) The Medicaid 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 Medicaid 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.
    (e)(1) The Unit may refer any provider with respect to which there 
is pending an investigation of a credible allegation of fraud under the 
Medicaid program to the Medicaid agency for payment suspension in whole 
or part under Sec. 455.23 of this title.
    (2) Referrals may be brief but must be in writing and include 
sufficient information to allow the Medicaid agency to identify the 
provider and to explain the credible allegations forming the grounds for 
the payment suspension.
    (f) Any request by the Unit to the Medicaid agency to delay 
notification to the provider of a payment suspension under Sec. 455.23 
of this title must be made promptly in writing.
    (g) The Unit should reach a decision on whether to accept a case 
referred by the Medicaid agency in a timely fashion. When the Unit 
accepts or declines a case referred by the Medicaid agency, the Unit 
promptly notifies the Medicaid agency in writing of the acceptance or 
declination of the case.
    (h) Upon request from the Medicaid agency on a quarterly basis under 
Sec. 455.23(d)(3)(ii), the Unit will certify that any matter accepted 
on the basis of a referral continues to be under investigation, thus 
warranting continuation of the payment suspension.



Sec. 1007.11  Duties and responsibilities of Unit.

    (a) The Unit will conduct a statewide program for investigating and 
prosecuting (or referring for prosecution) violations of all applicable 
State laws, including criminal statutes as well as civil false claims 
statutes or other civil authorities, pertaining to the following:
    (1) Fraud in the administration of the Medicaid program, the 
provision of medical assistance, or the activities of providers.
    (2) Fraud in any aspect of the provision of health care services and 
activities of providers of such services under

[[Page 1124]]

any Federal health care program (as defined in section 1128B(f)(1)of the 
Act), if the Unit obtains the written approval of the Inspector General 
of the relevant agency and the suspected fraud or violation of law in 
such case or investigation is primarily related to the State Medicaid 
program.
    (b)(1) The Unit will also review complaints alleging abuse or 
neglect of patients or residents in health care facilities receiving 
payments under Medicaid and may review complaints of the 
misappropriation of funds or property of patients or residents of such 
facilities.
    (2) At the option of the Unit, it may review complaints of abuse or 
neglect, including misappropriation of funds or property, of patients or 
residents of board and care facilities, regardless of whether payment to 
such facilities is made under Medicaid.
    (3) If the initial review of the complaint indicates substantial 
potential for criminal prosecution, the Unit will investigate the 
complaint or refer it to an appropriate criminal investigative or 
prosecutorial authority.
    (4) If the initial review does not indicate a substantial potential 
for criminal prosecution, the Unit will, if appropriate, refer the 
complaint to the proper Federal, State, or local agency.
    (c) If the Unit, in carrying out its duties and responsibilities 
under paragraphs (a) and (b) of this section, discovers that 
overpayments have been made to a health care facility or other provider, 
the Unit will either recover such overpayment as part of its resolution 
of a fraud case or refer the matter to the appropriate State agency for 
collection.
    (d) Where a prosecuting authority other than the Unit is to assume 
responsibility for the prosecution of a case investigated by the Unit, 
the Unit will ensure that those responsible for the prosecutorial 
decision and the preparation of the case for trial have the fullest 
possible opportunity to participate in the investigation from its 
inception and will provide all necessary assistance to the prosecuting 
authority throughout all resulting prosecutions.
    (e)(1) The Unit, if requested, will make available to OIG 
investigators and attorneys, or to other Federal investigators and 
prosecutors, all information in the Unit's possession concerning 
investigations or prosecutions conducted by the Unit.
    (2) The Unit will coordinate with OIG investigators and attorneys, 
or with other Federal investigators and prosecutors, on any Unit cases 
involving the same suspects or allegations that are also under 
investigation or prosecution by OIG or other Federal investigators or 
prosecutors.
    (3) The Unit will establish a practice of regular Unit meetings or 
communication with OIG investigators and Federal prosecutors.
    (4) When the Unit lacks the authority or resources to pursue a case, 
including for allegations of Medicare fraud and for civil false claims 
actions in a State without a civil false claims act or other State 
authority, the Unit will make appropriate referrals to OIG investigators 
and attorneys or other Federal investigators or prosecutors.
    (5) The Unit will establish written policy consistent with 
paragraphs (e)(1) through (4) of this section.
    (f) The Unit will guard the privacy rights of all beneficiaries and 
other individuals whose data is under the Unit's control and will 
provide adequate safeguards to protect sensitive information and data 
under the Unit's control.
    (g)(1) The Unit will transmit to OIG pertinent information on all 
convictions, including charging documents, plea agreements, and 
sentencing orders, for purposes of program exclusion under section 1128 
of the Act.
    (2) Convictions include those obtained either by Unit prosecutors or 
non-Unit prosecutors in any case investigated by the Unit.
    (3) Such information will be transmitted to OIG within 30 days of 
sentencing, or as soon as practicable if the Unit encounters delays in 
receiving the necessary information from the court.



Sec. 1007.13  Staffing requirements of Unit.

    (a) The Unit will employ sufficient professional, administrative, 
and support staff to carry out its duties and responsibilities in an 
effective and efficient manner.

[[Page 1125]]

    (b) The Unit will employ individuals from each of the following 
categories of professional employees, whose exclusive effort, as defined 
in Sec. 1007.1, is devoted to the work of the Unit:
    (1) One or more attorneys capable of prosecuting the Unit's health 
care fraud or criminal cases and capable of giving informed advice on 
applicable law and procedures and providing effective prosecution or 
liaison with other prosecutors;
    (2) One or more experienced auditors capable of reviewing financial 
records and advising or assisting in the investigation of alleged health 
care fraud and patient or resident abuse and neglect; and
    (3) One or more investigators capable of conducting investigations 
of health care fraud and patient or resident abuse and neglect matters, 
including a senior investigator who is capable of supervising and 
directing the investigative activities of the Unit.
    (c) The Unit will employ a director, as defined in Sec. 1007.1, who 
supervises all Unit employees.
    (d) Professional employees:
    (1) Will devote their exclusive effort to the work of the Unit, as 
defined in Sec. 1007.1 and except as provided in paragraphs (d)(2) and 
(3) of this section;
    (2) May be employed outside the Unit during nonduty hours, only if 
the employee is not:
    (i) Employed with a State agency (other than the Unit itself) or its 
contractors; or
    (ii) Employed with an entity whose mission poses a conflict of 
interest with Unit function and duties;
    (3) May perform non-Unit assignments for the State government only 
to the extent that such duties are limited in duration; and
    (4) Will be under the direction and supervision of the Unit 
director.
    (e) The Unit may employ administrative and support staff, such as 
paralegals, information technology personnel, interns, and secretaries, 
who may be full-time or part-time employees and must report to the Unit 
director or other Unit supervisor.
    (f) The Unit will employ, or have available to it, individuals who 
are knowledgeable about the provision of medical assistance under Title 
XIX of the Act and about the operations of health care providers.
    (g)(1) The Unit may employ, or have available through consultant 
agreements or other contractual arrangements, individuals who have 
forensic or other specialized skills that support the investigation and 
prosecution of cases.
    (2) The Unit may not, through consultant agreements or other 
contractual arrangements, rely on individuals not employed directly by 
the Unit for the investigation or prosecution of cases.
    (h) The Unit will provide training for its professional employees 
for the purpose of establishing and maintaining proficiency in Medicaid 
fraud and patient or resident abuse and neglect matters.



Sec. 1007.15  Establishment and certification of Unit.

    (a) Initial application. In order to demonstrate that it meets the 
requirements for certification, the State or territory must submit to 
OIG an application approved by the Governor or chief executive, 
containing the following:
    (1) A description of the applicant's organization, structure, and 
location within State government, and a statement of whether it seeks 
certification under Sec. 1007.7(a), (b), or (c);
    (2) A statement from the State Attorney General that the applicant 
has authority to carry out the functions and responsibilities set forth 
in Subpart B. If the applicant seeks certification under Sec. 
1007.7(b), the statement must also specify either that:
    (i) There is no State agency with the authority to exercise 
statewide prosecuting authority for the violations with which the Unit 
is concerned, or
    (ii) Although the State Attorney General may have common law 
authority for statewide criminal prosecutions, he or she has not 
exercised that authority;
    (3) A copy of whatever memorandum of agreement, regulation, or other 
document sets forth the formal procedures required under Sec. 
1007.7(b), or the formal working relationship and procedures required 
under Sec. 1007.7(c);

[[Page 1126]]

    (4) A copy of the agreement with the Medicaid agency required under 
Sec. Sec. 1007.9 and 455.21(c);
    (5) A statement of the procedures to be followed in carrying out the 
functions and responsibilities of this part;
    (6) A proposed budget for the 12-month period for which 
certification is sought; and
    (7) Current and projected staffing, including the names, education, 
and experience of all senior professional employees already employed and 
job descriptions, with minimum qualifications, for all professional 
positions.
    (b) Basis for, and notification of, certification. (1) OIG will make 
a determination as to whether the initial application under paragraph 
(a) of this section meets the requirements of Sec. Sec. 1007.5 through 
1007.13 and whether a Unit will be effective in using its resources in 
investigating Medicaid fraud and patient or resident abuse and neglect.
    (2) OIG will certify a Unit only if OIG specifically approves the 
applicant's formal written procedures under Sec. 1007.7(b) or (c), if 
either of those provisions is applicable.
    (3) If the application is not approved, the applicant may submit a 
revised application at any time.
    (4) OIG will certify a Unit that meets the requirements of this 
Subpart B for 12 months.



Sec. 1007.17  Annual recertification of Unit.

    (a) Information required annually for recertification. To continue 
receiving payments under this part, a Unit must submit to OIG:
    (1) Reapplication for recertification. Reapplication is due at least 
60 days prior to the expiration of the 12-month certification period. A 
reapplication must include:
    (i) A brief narrative that evaluates the Unit's performance, 
describes any specific problems it has had in connection with the 
procedures and agreements required under this part, and discusses any 
other matters that have impaired its effectiveness. The narrative should 
include any extended investigative authority approvals obtained pursuant 
to Sec. 1007.11(a)(2).
    (ii) For those Units approved to conduct data mining under Sec. 
1007.20, all costs expended by the Unit attributed to data mining 
activities; the amount of staff time devoted to data mining activities; 
the number of cases generated from those activities; the outcome and 
status of those cases, including the expected and actual monetary 
recoveries (both Federal and non-Federal share); and any other relevant 
indicia of return on investment from such activities.
    (iii) Information requested by OIG to assess compliance with this 
part and adherence to MFCU performance standards, including any 
significant changes in the information or documentation provided to OIG 
in the previous reporting period.
    (2) Statistical reporting. By November 30 of each year, the Unit 
will submit statistical reporting for the Federal fiscal year that ended 
on the prior September 30 containing the following statistics:
    (i) Unit staffing. The number of Unit employees, categorized by 
attorneys, investigators, auditors, and other employees, on board, and 
total number of approved Unit positions;
    (ii) Caseload. The number of open, new, and closed cases categorized 
by type of case and the number of open criminal and civil cases 
categorized by type of provider;
    (iii) Criminal case outcomes. The number of criminal convictions and 
indictments categorized by type of case and by type of provider; the 
number of acquittals, dismissals, referrals for prosecution, sentences, 
and other nonmonetary penalties categorized by type of case; and the 
amount of total ordered criminal recoveries categorized by type of 
provider; the amount of ordered Medicaid restitution, fines ordered, 
investigative costs ordered, and other monetary payment ordered 
categorized by type of case;
    (iv) Civil case outcomes. The number of civil settlements and 
judgments and recoveries categorized by type of provider; the number of 
global (coordinated among a group of States) civil settlements and 
successful judgments; the amount of global civil recoveries to the 
Medicaid program; the amount of other global civil monetary recoveries; 
the number of other civil cases opened, filed, or referred for filing; 
the number

[[Page 1127]]

of other civil case settlements and successful judgments; the amount of 
other civil case recoveries to the Medicaid program; the amount of other 
monetary recoveries; and the number of other civil cases declined or 
closed without successful settlement or judgment;
    (v) Collections. The monies actually collected on criminal and civil 
cases categorized by type of case; and
    (vi) Referrals. The number of referrals received categorized by 
source of referral and type of case; the number of cases opened 
categorized by source of referral and type of case; and the number of 
referrals made to other agencies categorized by type of case.
    (b) Other information reviewed for recertification. In addition to 
reviewing information required at Sec. 1007.17(a), OIG will review, as 
appropriate, the following information when considering recertification 
of a Unit:
    (1) Information obtained through onsite reviews and
    (2) Other information OIG deems necessary or warranted.
    (c) Basis for recertification. In reviewing the information 
described at Sec. 1007.17(a) and (b), OIG will evaluate whether the 
Unit has demonstrated that it effectively carries out the functions and 
requirements described in section 1903(q) of the Act as implemented by 
this part. In making that determination, OIG will take into 
consideration the following factors:
    (1) Unit's compliance with this part and other Federal regulations, 
including those specified in Sec. 1007.23;
    (2) Unit's compliance with OIG policy transmittals;
    (3) Unit's adherence to MFCU performance standards as published in 
the Federal Register;
    (4) Unit's effectiveness in using its resources in investigating 
cases of possible fraud in the administration of the Medicaid program, 
the provision of medical assistance, or the activities of providers of 
medical assistance under the State Medicaid plan, and in prosecuting 
cases or cooperating with the prosecuting authorities; and
    (5) Unit's effectiveness in using its resources in reviewing and 
investigating, referring for investigation or prosecution, or criminally 
prosecuting complaints alleging abuse or neglect of patients or 
residents in health care facilities receiving payments under the State 
Medicaid plan and, at the Unit's option, in board and care facilities.
    (d) Notification. OIG will notify the Unit by the Unit's 
recertification date of approval or denial of the recertification 
reapplication.
    (1) Approval subject to conditions. OIG may impose special 
conditions or restrictions and may require corrective action, as 
provided in 45 CFR 75.207, before approving a reapplication for 
recertification.
    (2) Written explanation for denials. If the reapplication is denied, 
OIG will provide a written explanation of the findings on which the 
denial was based.
    (e) Reconsideration of denial of recertification. (1) A Unit may 
request that OIG reconsider a decision to deny recertification by 
providing written information contesting the findings on which the 
denial was based.
    (2) Within 30 days of receipt of the request for reconsideration, 
OIG will provide a final decision in writing, explaining its basis for 
approving or denying the reconsideration of recertification.



             Subpart C_Federal Financial Participation (FFP)



Sec. 1007.19  FFP rate and eligible FFP costs.

    (a) Rate of FFP. (1) Subject to the limitation of this section, the 
Secretary of Health and Human Services must reimburse each State by an 
amount equal to 90 percent of the allowable costs incurred by a 
certified Unit during the first 12 quarters of operation that are 
attributable to carrying out its functions and responsibilities under 
this part. Each quarter of operation must be counted in determining when 
the Unit has accumulated 12 quarters of operation and is, therefore, no 
longer eligible for a 90-percent matching rate. Quarters of operation do 
not have to be consecutive to accumulate.
    (2) Beginning with the 13th quarter of operation, the Secretary must 
reimburse 75 percent of allowable costs incurred by a certified Unit.

[[Page 1128]]

    (b) Retroactive certification. OIG may grant certification 
retroactive to the date on which the Unit first met all the requirements 
of section 1903(q) of the Act and of this part. For any quarter with 
respect to which the Unit is certified, the Secretary will provide 
reimbursement for the entire quarter.
    (c) Total amount of FFP. FFP for any quarter must not exceed the 
higher of $125,000 or one-quarter of 1 percent of the sums expended by 
the Federal, State, and local governments during the previous quarter in 
carrying out the State Medicaid program.
    (d) Costs eligible for FFP. (1) FFP is allowable under this part for 
the expenditures attributable to the establishment and operation of the 
Unit, including the cost of training personnel employed by the Unit and 
efforts to increase referrals to the Unit through program outreach. 
Reimbursement is allowable only for costs attributable to the specific 
responsibilities and functions set forth in this part and if the Unit 
has been certified and recertified by OIG.
    (2) Establishment costs are limited to clearly identifiable costs of 
personnel that meet the requirements of Sec. 1007.13 of this part.
    (e) Costs not eligible for FFP. FFP is not allowable under this part 
for expenditures attributable to:
    (1) The investigation of cases involving program abuse or other 
failures to comply with applicable laws and regulations, if these cases 
do not involve substantial allegations or other indications of fraud, as 
described in Sec. 1007.11(a) of this part;
    (2) Routine verification with beneficiaries of whether services 
billed by providers were actually received, or, except as provided in 
Sec. 1007.20, efforts to identify situations in which a question of 
fraud may exist by the screening of claims and analysis of patterns and 
practice that involve data mining as defined in Sec. 1007.1.
    (3) The routine notification of providers that fraudulent claims may 
be punished under Federal or State law;
    (4) The performance of any audit or investigation, any professional 
legal function, or any criminal, civil or administrative prosecution of 
suspected providers by a person who does not meet the professional 
employee requirements in Sec. 1007.13(d);
    (5) The investigation or prosecution of fraud cases involving a 
beneficiary's eligibility for benefits, unless the suspected fraud cases 
also involve conspiracy with a provider;
    (6) Any payment, direct or indirect, from the Unit to the Medicaid 
agency, other than payments for the salaries of employees on detail to 
the Unit; or
    (7) Temporary duties performed by professional employees that are 
not required functions and responsibilities of the Unit, as described at 
Sec. 1007.13(d)(3).



Sec. 1007.20  Circumstances of permissible data mining.

    (a) Notwithstanding Sec. 1007.19(e)(2), a Unit may engage in data 
mining as defined in this part and receive FFP only under the following 
conditions:
    (1) The Unit identifies the methods of coordination between the Unit 
and the Medicaid agency, the individuals serving as primary points of 
contact for data mining, as well as the contact information, title, and 
office of such individuals;
    (2) Unit employees engaged in data mining receive specialized 
training in data mining techniques;
    (3) The Unit describes how it will comply with paragraphs (a)(1) and 
(2) of this section as part of the agreement required by Sec. 
1007.9(d); and
    (4) OIG, in consultation with CMS, approves in advance the 
provisions of the agreement as defined in paragraph (a)(3) of this 
section.
    (i) OIG will act on a request from a Unit for review and approval of 
the agreement within 90 days after receipt of a written request, or the 
request shall be considered approved if OIG fails to respond within 90 
days after receipt of the written request.
    (ii) If OIG requests additional information in writing, the 90-day 
period for OIG action on the request begins on the day OIG receives the 
information from the Unit.
    (iii) The approval is for 3 years.
    (iv) A Unit may request renewal of its data-mining approval for 
additional 3-year periods by submitting a written request for renewal to 
OIG, along with an updated agreement with the Medicaid agency.

[[Page 1129]]



Sec. 1007.21  Disallowance of claims for FFP.

    (a) Notice of disallowance and of right to reconsideration. When OIG 
determines that a Unit's claim or portion of a claim for FFP is not 
allowable, OIG shall promptly send to the Unit notification that meets 
the requirements listed at 42 CFR 430.42(a).
    (b) Reconsideration of disallowance. (1) The Principal Deputy 
Inspector General will reconsider Unit disallowance determinations made 
by OIG.
    (2) To request a reconsideration from the Principal Deputy Inspector 
General, the Unit must follow the requirements in 42 CFR 430.42(b)(2) 
and submit all required information to the Principal Deputy Inspector 
General. Copies should be sent via registered or certified mail to the 
Principal Deputy Inspector General.
    (3) The Unit may request to retain FFP during the reconsideration of 
the disallowance under section 1116(e) of the Act, in accordance with 42 
CFR 433.38.
    (4) The Unit is not required to request reconsideration before 
seeking review from the Departmental Appeals Board.
    (5) The Unit may also seek reconsideration, and following the 
reconsideration decision, request a review from the Departmental Appeals 
Board.
    (6) If the Unit elects reconsideration, the reconsideration process 
must be completed or withdrawn before requesting review by the 
Departmental Appeals Board.
    (c) Procedures for reconsideration of a disallowance. (1) Within 60 
days after receipt of the disallowance letter, the Unit shall, in 
accordance with paragraph (b)(2) of this section, submit in writing to 
the Principal Deputy Inspector General any relevant evidence, 
documentation, or explanation.
    (2) After consideration of the policies and factual matters 
pertinent to the issues in question, the Principal Deputy Inspector 
General 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 Principal Deputy Inspector General's option, OIG may 
request from the Unit 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 OIG and received by the Unit.
    (4) Within 30 days after receipt of the request for additional 
information, the Unit must submit to the Principal Deputy Inspector 
General all requested documents and materials.
    (i) If the Principal Deputy Inspector General finds that the 
materials are not in readily reviewable form or that additional 
information is needed, he or she shall notify the Unit 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 Unit does not provide the necessary materials within 15 
business days from the date of receipt of such notice, the Principal 
Deputy Inspector General shall affirm the disallowance in a final 
reconsideration decision issued within 15 days from the due date of 
additional information from the Unit.
    (5) If additional documentation is provided in readily reviewable 
form under paragraph (c)(4) of this section, the Principal Deputy 
Inspector General shall issue a written decision within 60 days from the 
due date of such information.
    (6) The final written decision shall constitute final OIG 
administrative action on the reconsideration and shall be (within 15 
business days of the decision) mailed to the Unit via registered or 
certified mail to establish the date the reconsideration decision was 
received by the Unit.
    (7) If the Principal Deputy Inspector General 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.
    (8) No section of this regulation shall be interpreted as waiving 
OIG'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 Unit

[[Page 1130]]

may withdraw the request for reconsideration at any time before the 
notice of the reconsideration decision is received by the Unit without 
affecting its right to submit a notice of appeal to the Departmental 
Appeals Board. The request for withdrawal must be in writing and sent to 
the Principal Deputy Inspector General via registered or certified mail.
    (2) Within 60 days after OIG's receipt of a Unit's withdrawal 
request, a Unit may, in accordance with (f)(2) of this section, submit a 
notice of appeal to the Departmental Appeals Board.
    (e) Implementation of decisions for reconsideration of a 
disallowance. (1) After undertaking a reconsideration, the Principal 
Deputy Inspector General may affirm, reverse, or revise the disallowance 
and shall issue a final written reconsideration decision to the Unit in 
accordance with paragraphs (c)(4) and (5) of this section.
    (2) If the reconsideration decision requires an adjustment of FFP, 
either upward or downward, a subsequent grant action will be made in the 
amount of such increase or decrease.
    (3) Within 60 days after receipt of a reconsideration decision from 
OIG, a Unit may, in accordance with paragraph (f) of this section, 
submit a notice of appeal to the Departmental Appeals Board.
    (f) Appeal of disallowance. (1) The Departmental Appeals Board 
reviews disallowances of FFP under Title XIX of the Act, including 
disallowances issued by OIG to the Units.
    (2) A Unit that wishes to appeal a disallowance to the Departmental 
Appeals Board must follow the requirements in 42 CFR 430.42(f)(2).
    (3) The appeals procedures are those set forth in 45 CFR part 16 for 
Medicaid and for many other programs, including the Units, administered 
by the Department.
    (4) The Departmental Appeals Board may affirm the disallowance, 
reverse the disallowance, modify the disallowance, or remand the 
disallowance to OIG for further consideration.
    (5) The Departmental Appeals Board will issue a final written 
decision to the Unit consistent with 45 CFR part 16.
    (6) If the appeal decision requires an adjustment of FFP, either 
upward or downward, a subsequent grant action will be made in the amount 
of such increase or decrease.



                       Subpart D_Other Provisions



Sec. 1007.23  Other applicable HHS regulations.

    The following regulations from 45 CFR, subtitle A, apply to grants 
under this part:
    (a) Part 16--Procedures of the Departmental Grant Appeals Board.
    (b) Part 75--Uniform Administrative Requirements, Cost Principles, 
and Audit Requirements for HHS Awards.
    (c) Part 80--Nondiscrimination under Programs Receiving Federal 
Assistance through HHS, Effectuation of Title VI of the Civil Rights Act 
of 1964.
    (d) Part 81--Practice and Procedure for Hearings under 45 CFR part 
80.
    (e) Part 84--Nondiscrimination on the Basis of Handicap in Programs 
and Activities Receiving Federal Financial Assistance.
    (f) Part 91--Nondiscrimination on the Basis of Age in Programs or 
Activities Receiving Federal Financial Assistance from HHS.



PART 1008_ADVISORY OPINIONS BY THE OIG--Table of Contents



                      Subpart A_General Provisions

Sec.
1008.1 Basis and purpose.
1008.3 Effective period.
1008.5 Matters subject to advisory opinions.

Subpart B_Preliminary Obligations and Responsibilities of the Requesting 
                                  Party

1008.11 Who may submit a request.
1008.15 Facts subject to advisory opinions.
1008.18 Preliminary questions suggested for the requesting party.

                     Subpart C_Advisory Opinion Fees

1008.31 OIG fees for the cost of advisory opinions.
1008.33 Expert opinions from outside sources.

    Subpart D_Submission of a Formal Request for an Advisory Opinion

1008.36 Submission of a request.

[[Page 1131]]

1008.37 Disclosure of ownership and related information.
1008.38 Signed certifications by the requestor.
1008.39 Additional information.
1008.40 Withdrawal.

          Subpart E_Obligations and Responsibilities of the OIG

1008.41 OIG acceptance of the request.
1008.43 Issuance of a formal advisory opinion.
1008.45 Rescission, termination or modification.
1008.47 Disclosure.

           Subpart F_Scope and Effect of OIG Advisory Opinions

1008.51 Exclusivity of OIG advisory opinions.
1008.53 Affected parties.
1008.55 Admissibility of evidence.
1008.59 Range of the advisory opinion.

    Authority: 42 U.S.C. 1320a-7d(b).

    Source: 62 FR 7357, Feb. 19, 1997, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1008.1  Basis and purpose.

    (a) This part contains the specific procedures for the submission of 
requests by an individual or entity for advisory opinions to, and the 
issuance of advisory opinions by, the OIG, in consultation with the 
Department of Justice (DoJ), in accordance with section 1128D(b) of the 
Social Security Act (Act), 42 U.S.C. 1320a-7d(b). The OIG will issue 
such advisory opinions based on actual or proposed factual circumstances 
submitted by the requesting individual or entity, or by counsel on 
behalf of the requesting individual or entity, provided all other 
requirements of this part are satisfied (including the requirement that 
the requesting individual or entity provide the certifications required 
in accordance with Sec. 1008.38 of this part).
    (b) An individual or entity may request an advisory opinion from the 
OIG regarding any of five specific subject matters described in Sec. 
1008.5 of this part.
    (c) The requesting party must provide a complete description of the 
facts as set forth in subpart B of this part, and pay the costs to the 
OIG of processing the request for an advisory opinion as set forth in 
subpart C of this part.
    (d) Nothing in this part limits the investigatory or prosecutorial 
authority of the OIG, DoJ or any other agency of the Government.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38324, July 16, 1998]



Sec. 1008.3  Effective period.

    The provisions in this part are applicable to requests for advisory 
opinions submitted on or after February 21, 1997, and before August 21, 
2000, and to any requests submitted during any other time period for 
which the OIG is required by law to issue advisory opinions.



Sec. 1008.5  Matters subject to advisory opinions.

    (a) An individual or entity may request an advisory opinion from the 
OIG regarding--
    (1) What constitutes prohibited remuneration within the meaning of 
section 1128B(b) of the Act;
    (2) Whether an arrangement, or proposed arrangement, satisfies the 
criteria set forth in section 1128B(b)(3) of the Act for activities that 
do not result in prohibited remuneration;
    (3) Whether an arrangement, or proposed arrangement, satisfies the 
criteria set forth in Sec. 1001.952 of this chapter for activities that 
do not result in prohibited remuneration;
    (4) What constitutes an inducement to reduce or limit services under 
section 1128A(b) of the Act to Medicare or Medicaid program 
beneficiaries; and
    (5) Whether any activity, or proposed activity, constitutes grounds 
for the imposition of a sanction under sections 1128, 1128A or 1128B of 
the Act.
    (b) Exceptions. The OIG will not address through the advisory 
opinion process--
    (1) What the fair market value will be, or whether fair market value 
was paid or received, for any goods, services or property; or
    (2) Whether an individual is a bona fide employee within the 
requirements of section 3121(d)(2) of the Internal Revenue Code of 1986.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38324, July 16, 1998]

[[Page 1132]]



Subpart B_Preliminary Obligations and Responsibilities of the Requesting 
                                  Party



Sec. 1008.11  Who may submit a request.

    Any individual or entity may submit a request to the OIG for an 
advisory opinion regarding an existing arrangement or one which the 
requestor in good faith specifically plans to undertake. The requestor 
must be a party to the arrangement, or proposed arrangement, that is the 
subject of the request.



Sec. 1008.15  Facts subject to advisory opinions.

    (a) The OIG will consider requests from a requesting party for 
advisory opinions regarding the application of specific facts to the 
subject matters set forth in Sec. 1008.5(a) of this part. The facts 
must relate to an existing arrangement, or one which the requestor in 
good faith plans to undertake. The plans may be contingent upon 
receiving a favorable advisory opinion. The advisory opinion request 
should contain a complete description of the arrangement that the 
requestor is undertaking, or plans to undertake.
    (b) Requests presenting a general question of interpretation, posing 
a hypothetical situation, or regarding the activities of third parties 
do not qualify as advisory opinion requests.
    (c) Advisory opinion request will not be accepted, and/or opinions 
will not be issued when--
    (1) The request is not related to a named individual or entity;
    (2) The same, or substantially the same, course of action is under 
investigation, or is or has been the subject of a proceeding involving 
the Department of Health and Human Services or another governmental 
agency; or
    (3) An informed opinion cannot be made, or could be made only after 
extensive investigation, clinical study, testing, or collateral inquiry.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38324, July 16, 1998]



Sec. 1008.18  Preliminary questions suggested for the requesting party.

    (a) The OIG may establish and maintain a set of questions 
corresponding to the categories of opinion subject matter as set forth 
in Sec. 1008.5(a) of this part as appropriate. The questions will be 
designed to elicit specific information relevant to the advisory opinion 
being sought; however, answering the questions is voluntary.
    (b) Questions the OIG suggests that the requestor address may be 
obtained from the OIG. Requests should be made in writing, specify the 
subject matter, and be sent to the headquarter offices of the OIG.
    (c) When submitting a request for an advisory opinion, a requestor 
may answer the questions corresponding to the subject matter for which 
the opinion is requested. The extent to which any of the questions is 
not fully answered may effect the content of the advisory opinion.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38324, July 16, 1998]



                     Subpart C_Advisory Opinion Fees



Sec. 1008.31  OIG fees for the cost of advisory opinions.

    (a) Responsibility for fees. The requestor is responsible for paying 
a fee equal to the costs incurred by the Department in responding to the 
request for an advisory opinion.
    (b) Payment Method. Payment for a request for an advisory opinion 
must be made to the Treasury of the United States, as directed by OIG.
    (c) Calculation of costs: Prior to the issuance of the advisory 
opinion, the OIG will calculate the costs incurred by the Department in 
responding to the request. The calculation will include the costs of 
salaries and benefits payable to attorneys and others who have worked on 
the request in question, as well as administrative and supervisory 
support for such person. The OIG has the exclusive authority to 
determine the cost of responding to a request for an advisory opinion 
and such determination is not reviewable or waiveable.
    (d) Agreement to pay all costs. (1) By submitting the request for an 
advisory opinion, the requestor agrees, except as indicated in paragraph 
(d)(4) of this section, to pay all costs incurred by the OIG in 
responding to the request for an advisory opinion.

[[Page 1133]]

    (2) In its request for an advisory opinion, the requestor may 
request a written estimate of the cost involved in processing the 
advisory opinion. Within 10 business days of receipt of the request, the 
OIG will notify in writing of such estimate. Such estimate will not be 
binding on the Department, and the actual cost to be paid may be higher 
or lower than estimated. The time period for issuing the advisory 
opinion will be tolled from the time the OIG notifies the requestor of 
the estimate until the OIG receives written confirmation from the 
requestor that the requestor wants the OIG to continue processing the 
request. Such notice may include a new or revised triggering dollar 
amount, as set forth in paragraph (d)(3) of this section.
    (3) In its request for an advisory opinion, the requestor may 
designate a triggering dollar amount. If the OIG estimates that the 
costs of processing the advisory opinion request have reached, or are 
likely to exceed, the designated triggering dollar amount, the OIG will 
notify the requestor. The requestor may revise its designated triggering 
dollar amount in writing in its response to notification of a cost 
estimate in accordance with paragraph (d)(2) of this section.
    (4) If the OIG notifies the requestor that the estimated cost of 
processing the request has reached or is likely to exceed the triggering 
dollar amount, the OIG will stop processing the request until such time 
as the requestor makes a written request for the OIG to continue 
processing the request. Any delay in the processing of the request for 
an advisory opinion attributable to these procedures will toll the time 
for issuance of an advisory opinion until the requestor asks the OIG to 
continue working on the request.
    (5) If the requestor chooses not to pay for completion of an 
advisory opinion, or withdraws the request, the requestor is still 
obligated to pay for all costs incurred and identified by the OIG 
attributable to processing the request for an advisory opinion up to 
that point.
    (6) If the costs incurred by the OIG in responding to the request 
are greater than the amount paid by the requestor, the OIG will, prior 
to the issuance of the advisory opinion, notify the requestor of any 
additional amount due. The OIG will not issue an advisory opinion until 
the full amount owed by the requestor has been paid. Once the requestor 
has paid the OIG the total amount due for the costs of processing the 
request, the OIG will issue the advisory opinion. The time period for 
issuing advisory opinions will be tolled from the time the OIG notifies 
the requestor of the amount owed until the time full payment is 
received.
    (e) Fees for outside experts. (1) In addition to the fees identified 
in this section, the requestor also must pay any required fees for 
expert opinions, if any, from outside sources, as described in Sec. 
1008.33.
    (2) If the OIG determines that it is necessary to obtain expert 
advice to issue a requested advisory opinion, the OIG will notify the 
requestor of that fact and provide the identity of the appropriate 
expert and an estimate of the costs of the expert advice.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38324, July 16, 1998; 73 
FR 15939, Mar. 26, 2008]



Sec. 1008.33  Expert opinions from outside sources.

    (a) The OIG may request expert advice from qualified sources on non-
legal issues if necessary to respond to the advisory opinion request. 
For example, the OIG may require the use of appropriate medical 
reviewers, such as quality improvement organizations, to obtain medical 
opinions on specific issues.
    (b) The time period for issuing an advisory opinion will be tolled 
from the time that the OIG notifies the requestor of the need for an 
outside expert opinion until the time the OIG receives the necessary 
expert opinion.
    (c) Once payment is made for the cost of the expert opinion, as set 
forth in Sec. 1008.31(e) of this part, either directly to the expert or 
otherwise, the OIG will arrange for a prompt expert review of the issue 
or issues in question. Regardless of the manner of payment, the expert's 
work and opinion will be subject to the sole direction of the OIG.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38325, July 16, 1998]

[[Page 1134]]



    Subpart D_Submission of a Formal Request for an Advisory Opinion



Sec. 1008.36  Submission of a request.

    (a) A request for a formal advisory opinion must be submitted in 
writing. An original and 2 copies of the request should be addressed to 
the headquarter offices of the OIG.
    (b) Each request for an advisory opinion must include--
    (1) To the extent known to the requestor, the identities, including 
the names and addresses, of the requestor and of all other actual and 
potential parties to the arrangement, that are the subject of the 
request for an advisory opinion;
    (2) The name, title, address, and daytime telephone number of a 
contact person who will be available to discuss the request for an 
advisory opinion with the OIG on behalf of the requestor;
    (3) A declaration of the subject category or categories as described 
in Sec. 1008.5 of this part for which the advisory opinion is 
requested. To the extent an individual or entity requests an advisory 
opinion in accordance with Sec. 1008.5(a)(3) or (a)(5) of this part, 
the requesting individual or entity should identify the specific 
subsections of sections 1128, 1128A or 1128B of the Act or the specific 
provision of Sec. 1001.952 of this chapter about which an advisory 
opinion is sought:
    (4) A complete and specific description of all relevant information 
bearing on the arrangement for which an advisory opinion is requested 
and on the circumstances of the conduct, \1\ including--
---------------------------------------------------------------------------

    \1\ The requestor is under an affirmative obligation to make full 
and true disclosure with respect to the facts regarding the advisory 
opinion being requested.
---------------------------------------------------------------------------

    (i) Background information,
    (ii) For existing arrangements, complete copies of all operative 
documents,
    (iii) For proposed arrangements, complete copies of all operative 
documents, if possible, and otherwise descriptions of proposed terms, 
drafts, or models of documents sufficient to permit the OIG to render an 
informed opinion,
    (iv) Detailed statements of all collateral or oral understandings, 
if any, and
    (v) If applicable, a designation of trade secrets or confidential 
commercial or financial information in the manner described in 45 CFR 
5.41;
    (5) Signed certifications by the requestor(s), as described in Sec. 
1008.37 of this part;
    (6) A declaration regarding whether an advisory opinion in 
accordance with part 411 of this title has been or will be requested 
from CMS about the arrangement that is the subject of the advisory 
opinion request; and
    (7) Each requesting party's Taxpayer Identification Number.

(Approved by the Office of Management and Budget under control number 
0990-0213)

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38325, July 16, 1998; 73 
FR 15939, Mar. 26, 2008; 85 FR 72910, Nov. 16, 2020]



Sec. 1008.37  Disclosure of ownership and related information.

    Each individual or entity requesting an advisory opinion must supply 
full and complete information as to the identity of each entity owned or 
controlled by the individual or entity, and of each person with an 
ownership or control interest in the entity, as defined in section 
1124(a)(1) of the Social Security Act (42 U.S.C. 1320a-3(a)(1)) and part 
420 of this chapter.

(Approved by the Office of Management and Budget under control number 
0990-0213)

[67 FR 11936, Mar. 18, 2002]



Sec. 1008.38  Signed certifications by the requestor.

    (a) Every request must include the following signed certification 
from all requestors: ``With knowledge of the penalties for false 
statements provided by 18 U.S.C. 1001 and with knowledge that this 
request for an advisory opinion is being submitted to the Department of 
Health and Human Services, I certify that all of the information 
provided is true and correct, and constitutes a complete description of 
the facts regarding which an advisory opinion is sought, to the best of 
my knowledge and belief.''
    (b) If the advisory opinion relates to a proposed arrangement, the 
request must also include the following signed

[[Page 1135]]

certification from all requestors: ``The arrangement described in this 
request for an advisory opinion is one that [the requestor(s)] in good 
faith plan(s) to undertake.'' This statement may be made contingent on a 
favorable OIG advisory opinion, in which case, the phrase ``if the OIG 
issues a favorable advisory opinion'' should be added to the 
certification.
    (c) The certification(s) must be signed by--
    (1) The requestor, if the requestor is an individual;
    (2) The chief executive officer, or comparable officer, of the 
requestor, if the requestor is a corporation;
    (3) The managing partner of the requestor, if the requestor is a 
partnership; or
    (4) The managing member, or comparable person, if the requestor is a 
limited liability company.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38325, July 16, 1998]



Sec. 1008.39  Additional information.

    (a) If the request for an advisory opinion does not contain all of 
the information required by Sec. 1008.36 of this part, or the OIG 
believes it needs more information prior to rendering an advisory 
opinion, the OIG may, at any time, request whatever additional 
information or documents it deems necessary. The time period for the 
issuance of an advisory opinion will be tolled from the time the OIG 
requests the additional information from the requestor until such time 
as the OIG determines that it has received the requested information.
    (b) The OIG may request additional information before or after the 
request for an advisory opinion has been accepted.
    (c) Additional information should be provided in writing and 
certified to be a true, correct and complete disclosure of the requested 
information in a manner equivalent to that described in Sec. 1008.38 of 
this part.
    (d) In connection with any request for an advisory opinion, the OIG 
or DoJ may conduct whatever independent investigation they believe 
appropriate.
    (e) Requesting parties are required to notify the OIG if they 
request an advisory opinion in accordance with part 411 of this title 
from CMS about the arrangement that is the subject of their advisory 
opinion request.
    (f) Where appropriate, after receipt of an advisory opinion request, 
the OIG may consult with the requesting parties to the extent the OIG 
deems necessary.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38325, July 16, 1998]



Sec. 1008.40  Withdrawal.

    The requestor of an advisory opinion may withdraw the request prior 
to the issuance of a formal advisory opinion by the OIG. The withdrawal 
must be written and must be submitted to the same address as the 
submitted request, as indicated in Sec. Sec. 1008.18(b) and 1008.36(a) 
of this part. Regardless of whether the request is withdrawn, the 
requestor must pay the costs expended by the OIG in processing the 
opinion, as discussed in Sec. 1008.31(d) of this part. The OIG reserves 
the right to retain any request for an advisory opinion, documents and 
information submitted to it under these procedures, and to use them for 
any governmental purposes.



          Subpart E_Obligations and Responsibilities of the OIG



Sec. 1008.41  OIG acceptance of the request.

    (a) Upon receipt of a request for an advisory opinion, the OIG will 
promptly make an initial determination whether the submission includes 
all of the information the OIG will require to process the request.
    (b) Within 10 working days of receipt of the request, the OIG will--
    (1) Formally accept the request for an advisory opinion,
    (2) Notify the requestor of what additional information is needed, 
or
    (3) Formally decline to accept the request.
    (c) If the requestor provides the additional information requested, 
or otherwise resubmits the request, the OIG will process the 
resubmission in accordance with paragraphs (a) and (b) of this section 
as if it was an initial request for an advisory opinion.
    (d) Upon acceptance of the request, the OIG will notify the 
requestor by

[[Page 1136]]

regular U.S. mail of the date that the request for the advisory opinion 
was formally accepted.
    (e) The 60-day period for issuance of an advisory opinion set forth 
in Sec. 1008.43(c) of this part will not commence until the OIG has 
formally accepted the request for an advisory opinion.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38326, July 16, 1998]



Sec. 1008.43  Issuance of a formal advisory opinion.

    (a) An advisory opinion will be considered issued once payment is 
received and it is dated, numbered, and signed by an authorized official 
of the OIG.
    (b) An advisory opinion will contain a description of the material 
facts provided to the OIG with regard to the arrangement for which an 
advisory opinion has been requested. The advisory opinion will state the 
OIG's opinion regarding the subject matter of the request based on the 
facts provided to the OIG. If necessary, to fully describe the 
arrangement, the OIG is authorized to include in the advisory opinion 
the material facts of the arrangement, notwithstanding that some of 
these facts could be considered confidential information or trade 
secrets within the meaning of 18 U.S.C. 1905.
    (c)(1) The OIG will issue an advisory opinion, in accordance with 
the provisions of this part, within 60 days after the request for an 
advisory opinion has been formally accepted;
    (2) If the 60th day falls on a Saturday, Sunday, or Federal holiday, 
the time period will end at the close of the next business day following 
the weekend or holiday;
    (3) The 60 day period will be tolled from the time the OIG--
    (i) Notifies the requestor that the costs have reached, or are 
likely to exceed, the triggering amount until the time when the OIG 
receives written notice from the requestor to continue processing the 
request;
    (ii) Requests additional information from the requestor until the 
time the OIG receives the requested information;
    (iii) Notifies the requestor of the full amount due until the time 
the OIG receives payment of the full amount owed; and
    (iv) Notifies the requestor of the need for expert advice until the 
time the OIG receives the expert advice.
    (d) After OIG has notified the requestor of the full amount owed and 
OIG has determined that the full payment of that amount has been 
properly paid by the requestor, OIG will issue the advisory opinion and 
promptly mail it to the requestor by regular first class U.S. mail.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38326, July 16, 1998; 73 
FR 15939, Mar. 26, 2008]



Sec. 1008.45  Rescission, termination or modification.

    (a) Any advisory opinion given by the OIG is without prejudice to 
the right of the OIG to reconsider the questions involved and, where the 
public interest requires, to rescind, terminate or modify the advisory 
opinion. Requestors will be given a preliminary notice of the OIG's 
intent to rescind, terminate or modify the opinion, and will be provided 
a reasonable opportunity to respond. A final notice of rescission, 
termination or modification will be given to the requestor so that the 
individual or entity may discontinue or modify, as the case may be, the 
course of action taken in accordance with the OIG advisory opinion.
    (b) For purposes of this part--
    (1) To rescind an advisory opinion means that the advisory opinion 
is revoked retroactively to the original date of issuance with the 
result that the advisory opinion will be deemed to have been without 
force and effect from the original date of issuance. Recission may occur 
only where relevant and material facts were not fully, completely and 
accurately disclosed to the OIG.
    (2) To terminate an advisory opinion means that the advisory opinion 
is revoked as of the termination date and is no longer in force and 
effect after the termination date. The OIG will not proceed against the 
requestor under this part if such action was promptly, diligently, and 
in good faith discontinued in accordance with reasonable time frames 
established by the OIG after consultation with the requestor.

[[Page 1137]]

    (3) To modify an advisory opinion means that the advisory opinion is 
amended, altered, or limited, and that the advisory opinion continues in 
full force and effect in modified form thereafter. The OIG will not 
proceed against the requestor under this part if such action was 
promptly, diligently, and in good faith modified in accordance with 
reasonable time frames established by the OIG after consultation with 
the requestor.

[63 FR 38326, July 16, 1998]



Sec. 1008.47  Disclosure.

    (a) Advisory opinions issued and released in accordance with the 
provisions set forth in this part will be available to the public.
    (b) Promptly after the issuance and release of an advisory opinion 
to the requestor, a copy of the advisory opinion will be available for 
public inspection between the hours of 10:00 a.m. and 3:00 p.m. on 
normal business days at the headquarter offices of the OIG and on the 
DHHS/OIG web site.
    (c) Any pre-decisional document, or part of such pre-decisional 
document, that is prepared by the OIG, DoJ, or any other Department or 
agency of the United States in connection with an advisory opinion 
request under the procedures set forth in this part generally will be 
exempt from disclosure under 5 U.S.C. 552, and will not be made publicly 
available.
    (d) Documents submitted by the requestor to the OIG in connection 
with a request for an advisory opinion may be available to the public in 
accordance with 5 U.S.C. 552 through procedures set forth in 45 CFR part 
5.
    (e) Nothing in this section will limit the OIG's right, in its 
discretion, to issue a press release or otherwise publicly disclose the 
identity of the requesting party or parties, and the nature of the 
action taken by the OIG upon the request.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38326, July 16, 1998]



           Subpart F_Scope and Effect of OIG Advisory Opinions



Sec. 1008.51  Exclusivity of OIG advisory opinions.

    The only method for obtaining a binding advisory opinion regarding 
any of the subject matters set forth in Sec. 1008.5(a) is through the 
procedures described in this part. No binding advisory opinion, oral or 
written, has or may be issued by the OIG regarding the specific matters 
set forth in Sec. 1008.5(a) except through written opinions issued in 
accordance with this part.



Sec. 1008.53  Affected parties.

    An advisory opinion issued by the OIG will have no application to 
any individual or entity that does not join in the request for the 
opinion. No individual or entity other than the requestor(s) may rely on 
an advisory opinion.



Sec. 1008.55  Admissibility of evidence.

    (a) The failure of a party to seek an advisory opinion may not be 
introduced into evidence to prove that the party intended to violate the 
provisions of sections 1128, 1128A or 1128B of the Act.
    (b) An advisory opinion may not be introduced into evidence by a 
person or entity that was not the requestor of the advisory opinion to 
prove that the person or entity did not violate the provisions of 
sections 1128, 1128A or 1128B of the Act or any other law.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38326, July 16, 1998]



Sec. 1008.59  Range of the advisory opinion.

    (a) An advisory opinion will state only the OIG's opinion regarding 
the subject matter of the request. If the arrangement for which an 
advisory opinion is requested is subject to approval or regulation by 
any other Federal, State or local government agency, such advisory 
opinion may not be taken to indicate the OIG's views on the legal or 
factual issues that may be raised before that agency. The OIG will not 
provide any legal opinion on questions or issues regarding an authority 
which is

[[Page 1138]]

vested in other Federal, State or local government agencies.
    (b) An advisory opinion issued under this part will not bind or 
obligate any agency other than the Department. It will not affect the 
requestor's, or anyone else's, obligations to any other agency, or under 
any statutory or regulatory provision other than that which is the 
specific subject matter of the advisory opinion.

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38326, July 16, 1998]

                       PARTS 1009	1099 [RESERVED]

[[Page 1139]]



                              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 1141]]



                    Table of CFR Titles and Chapters




                     (Revised as of October 1, 2021)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 1142]]

     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 1143]]

    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 1144]]

     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 1145]]

        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 1146]]

         L  Rural Business-Cooperative Service, and Rural 
                Utilities Service, Department of Agriculture 
                (Parts 5000--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 1147]]

        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 1148]]

      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 1149]]

                     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 1150]]

                          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 1151]]

        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 1152]]

        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 1153]]

         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 1154]]

                          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 1155]]

       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 1156]]

       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management
       201  Federal Acquisition Security Council (Part 201)
            Subtitle E [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 1157]]

                       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 1158]]

                      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 1159]]

        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 1160]]

        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 1161]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of October 1, 2021)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 1162]]

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 1163]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Office of the Under-Secretary   15, XV
     for
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
     States
[[Page 1164]]

Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102

[[Page 1165]]

  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 1166]]

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 1167]]

  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 1168]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of, and     32, XXIV; 47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
   Office of
[[Page 1169]]

State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Great Lakes St. Lawrence Seaway Development     33, IV
       Corporation
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
U.S. Office of Special Counsel                    5, CII
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 1171]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2016 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2016

42 CFR
                                                                   81 FR
                                                                    Page
Chapter I
482.15 Added; eff. 11-15-16........................................64028
    (h)(1)(xiii) correctly redesignated as (h)(1)(xii).............80594
482.41 (b)(4) and (5) removed; (b)(6) through (9) and (c) 
        redesignated as new (b)(4) through (7) and (d); (b)(1)(i), 
        (ii), (2) and new (7) revised; new (b)(8), (9), new (c) 
        and (e) added..............................................26899
    (b)(1)(i) corrected............................................42548
482.58 (b)(1) through (8) revised..................................68847
482.68 Revised; eff. 11-15-16......................................64030
482.78 Added; eff. 11-15-16........................................64030
482.80 (c)(2)(ii)(C) revised.......................................79880
482.82 (c)(2)(ii)(C) revised.......................................79880
483.1 (a)(1) introductory text, (3) and (b) revised; (a)(4) and 
        (5) added..................................................68848
483.5 (a) through (f) designations removed; introductory text 
        added; amended.............................................68848
483.10 Revised.....................................................68849
483.12 Revised.....................................................68855
483.13 Removed.....................................................68855
483.15 (h)(4) amended..............................................26899
    Revised........................................................68855
483.20 (j)(1)(i) and (ii) amended..................................61563
    (k) and (l) removed; (m) redesignated as new (k); (b)(1) 
introductory text, (xvi), (xviii), (e) and new (k) revised.........68857
483.21 Added.......................................................68858
483.24 Added.......................................................68859
483.25 Revised.....................................................68860
483.30 Redesignated as 483.35; redesignated from 483.40; 
        introductory text and (b)(3) revised; (e)(1) introductory 
        text amended; (e)(2) redesignated as (e)(4); new (e)(2) 
        and (3) added..............................................68861
483.35 Redesignated as 483.60; redesignated from 483.30; (c), (d) 
        and (e) redesignated as (e), (f) and (g); (a)(3), (4), new 
        (c) and (d) added; introductory text, (a)(1)(ii), new 
        (e)(6), (7) and new (f)(1)(iv) and (v) revised; (a)(1)(i), 
        (b)(1) and (2) amended.....................................68861
483.40 Redesignated as 483.30......................................68861
    Added..........................................................68862
483.45 Redesignated as 483.65; redesignated from 483.60............68861
    Introductory text amended; (c)(2), (d) and (e) redesignated as 
(c)(4), (g) and (h); new (c)(2), (3), (d), (e) and (f) added; new 
(c)(4) revised.....................................................68863
483.50 Added.......................................................68863

[[Page 1172]]

483.55 (a)(1) and (b)(1) introductory text amended; (a)(3) and (4) 
        redesignated as (a)(4) and (5); new (a)(3), (b)(4) and (5) 
        added; new (a)(4) introductory text, (ii), (5), (b)(2) 
        introductory text, (ii) and (3) revised....................68864
483.60 Redesignated as 483.45; redesignated from 483.35............68861
    Revised........................................................68864
483.65 Redesignated as 483.80; redesignated from 483.45............68861
    (a) introductory text and (2) revised..........................68865
483.70 (a)(4) and (5) removed; (a)(6), (7), (8) and (b) through 
        (h) redesignated as new (a)(4), (5), (6) and (c) through 
        (i); (a)(1)(i), (ii), (2), new (4) revised; new (a)(7), 
        (8), new (b) and (j) added.................................26899
    (a)(8) introductory text corrected.............................42548
    Redesignated as 483.90; redesignated from 483.75...............68861
    (f), (j), (k), (m), (o) and (q) removed; (g), (h), (i), (l), 
(n), (p) and (r) through (u) redesignated as new (f) through (m), 
new (o) and new (q); (c), (d)(2), (e), new (i)(1) introductory 
text, (2) through (5), new (j)(1)(i), (ii) and new (m) revised; 
(d)(3), new (n) and new (p) added; new (g)(1), new (k)(3), new (m) 
and new (o)(2) introductory text amended...........................68865
483.73 Added; eff. 11-15-16........................................64030
    (g)(1)(xiii) correctly redesignated as (g)(1)(xii).............80594
483.75 (m) removed; eff. 11-15-16..................................64032
    Redesignated as 483.70.........................................68861
    Added..........................................................68867
483.80 Redesignated from 483.65....................................68861
    Revised........................................................68868
483.85 Added.......................................................68869
483.90 Redesignated from 483.70....................................68861
    (c), (e)(1)(i), (2)(i), (f), (g) introductory text, (1) and 
(h)(2) revised; (i)(5) added.......................................68870
483.95 Added.......................................................68870
483.118 (b)(1) and (c)(2)(i) amended...............................68871
483.130 (m)(5) and (6) amended.....................................68871
483.138 (a) introductory text and (b)(1) amended...................68871
483.151 (b)(2)(iv), (3)(iii) and (c)(1) amended....................61563
    (a)(3) amended.................................................68871
483.204 (b) amended................................................68871
483.206 (a) amended................................................68871
483.470 (j)(5) and (6) removed; (j)(7) redesignated as new (j)(5); 
        (j)(1)(i), (ii) and new (5) revised; (j)(1)(iii), (iv) and 
        (m) added..................................................26900
483.470 (h) removed; eff. 11-15-16.................................64032
483.475 Added; eff. 11-15-16.......................................64032
484.22 Added; eff. 11-15-16........................................64033
    (d)(1)(ii) correctly redesignated as (d)(1)(iv)................80594
484.202 Amended....................................................76796
484.205 (b) introductory text revised..............................76796
484.240 (d) revised................................................76796
484.305 Amended....................................................76796
484.315 (a) revised................................................76796
484.320 (a) through (d) amended....................................76796
484.335 Added......................................................76796
485.64 Removed; eff. 11-15-16......................................64035
485.68 Added; eff. 11-15-16........................................64035
485.623 (d)(5) and (6) removed; (d)(7) redesignated as new (d)(5); 
        (d)(1)(i), (ii), (2) and new (5) revised; new (d)(6), (e) 
        and (f) added..............................................26901
    (c) removed; (d), (e) and (f) redesignated as new (c), (d) and 
(e); eff. 11-15-16.................................................64036
485.625 Added; eff. 11-15-16.......................................64036
    (g)(1)(xiii) correctly redesignated as (g)(1)(xii).............80594
485.635 (a)(3)(vii) amended........................................68871
485.645 (d)(1) through (9) revised; (d)(10) added..................68871
485.727 Revised; eff. 11-15-16.....................................64037
485.920 Added; eff. 11-15-16.......................................64039
486.302 Amended....................................................79880
486.318 (a)(3) and (b)(3) revised..................................79881
486.346 (b) revised................................................79881
486.360 Added; eff. 11-15-16.......................................64040
488.56 (a) introductory text amended...............................68871
488.61 (f)(1) introductory text, (3) and (h)(2) revised............79881
488.301 Amended....................................................68871

[[Page 1173]]

488.307 (c) amended................................................61563
488.408 (d)(1)(iii), (iv), (e)(1)(iii), (iv) and (2)(ii) amended 
                                                                   61563
488.426 (b) and (c) amended........................................68872
488.438 (a)(1)(i), (ii) and (2) amended............................61563
488.446 (a)(1), (2) and (3) amended................................61563

488.446 Introductory text amended..................................68872
488.725 (c) amended................................................61563
488.845 (b)(2)(iii), (3) introductory text, (i), (ii), (iii), (4), 
        (5), (6) and (d)(1)(ii) amended............................61563
489 Authority citation revised.....................................57273
    Technical correction....................................68947, 75328
489.20 (y) added...................................................57273
489.52 (a)(2) amended..............................................68872
489.55 (b) amended.................................................68872
491.6 (c) removed; eff. 11-15-16...................................64041
491.12 Added; eff. 11-15-16........................................64041
493.1834 (d)(2)(i) and (ii) amended................................61564
494 Technical correction...........................................94268
494.1 (a)(3) revised; (a)(7) added.................................77969
494.60 (d) removed; (e) redesignated as new (d); eff. 11-15-16.....64042
494.62 Added; eff. 11-15-16........................................64042
494.70 (c) redesignated as (d); new (c) added; interim.............90227
494.180 (k) added; interim.........................................90228
495 Technical correction...........................................34908
495.4 Correctly amended............................................34909
    Amended.................................................77555, 79882
495.22 (e)(3)(ii)(C)(3) and (10)(ii)(C)(3) introductory text 
        correctly amended..........................................11449
    (a), (c)(1), (d)(1) and (e) heading revised; (f) added.........79882
495.24 (d)(7)(i)(B)(3) introductory text and (ii)(B)(3) 
        introductory text correctly amended........................11449
    (d)(7)(ii)(B)(2) correctly amended.............................34909
    Revised........................................................79884
495.40 (a) introductory text, (2)(i)(E), (F), (b) introductory 
        text, (2)(i)(E) and (F) revised; (b)(2)(i)(G) redesignated 
        as (b)(2)(i)(H); (a)(2)(i)(G) and new (b)(2)(i)(G) added 
                                                                   79892
    (a) introductory text, (2)(i)(E), (F) and (b) introductory 
text revised; (a)(2)(i)(G), (H), (I), (b)(2)(i)(H) and (I) added 
                                                                   77556
495.102 (d)(1), (2)(iv) and (3) revised............................77557
    (d)(4)(v) added................................................79892
495.316 (g)(2) revised; (g)(3) added...............................77557
495.332 (d)(2) amended.............................................27901
495.366 (e)(7) amended.............................................27901
510.300 (a)(4) correctly removed; (a)(5) correctly redesignated as 
        new (a)(4); (c)(2)(iii) correctly added....................11451
510.305 (f)(1)(iii) correctly amended..............................11451
600 Policy statement; eff. 1-1-17..................................10091
Chapter V
1001.952 (w)(7) amended; undesignated text following (w)(9) 
        designated as (w) Note; interim.............................3012
    (f)(2) and (k) revised; (z), (aa) and (bb) added...............88407
1003.100--1003.135 (Subpart A) Designated as Subpart A; heading 
        added......................................................88354
1003.100 Revised...................................................88354
1003.101 Redesignated as 1003.110..................................88355
1003.102 Removed...................................................88355
1003.103 (a)(1), (2), (b), (c), (d)(1), (e)(1), (2), (f)(1) 
        introductory text, (2) introductory text, (3) introductory 
        text, (5), (g), (h)(1), (i)(1) and (j) through (m) amended
                                                                   61564
    Removed........................................................88355
1003.104 Removed...................................................88355
1003.105 Removed...................................................88355
1003.106 Removed...................................................88355
1003.107 Removed...................................................88355
1003.108 Removed...................................................88355
1003.109 Removed...................................................88355
1003.110 Removed; redesignated from 1003.101; amended..............88355
    Amended........................................................88409
1003.114 Removed...................................................88355
1003.120 Added.....................................................88356
1003.126 Removed...................................................88355
1003.127 Removed...................................................88355
1003.128 Removed...................................................88355
1003.129 Removed...................................................88355
1003.130 Added.....................................................88356

[[Page 1174]]

1003.132 Removed...................................................88355
1003.133 Removed...................................................88355
1003.134 Removed...................................................88355
1003.135 Removed...................................................88355
1003.140 Added.....................................................88356
1003.150 Added.....................................................88356
1003.160 Added.....................................................88356
1003.200--1003.220 (Subpart B) Added...............................88357
1003.300--1003.320 (Subpart C) Added...............................88357
1003.400--1003.420 (Subpart D) Added...............................88357
1003.500--1003.520 (Subpart E) Added...............................88357
1003.600--1003.620 (Subpart F) Added...............................88357
1003.800--1003.820 (Subpart H) Added...............................88362
1003.900--1003.920 (Subpart I) Added...............................88362
1003.1000--1003.1020 (Subpart J) Added.............................88362
1003.1100--1003.1120 (Subpart K) Added.............................88362
1003.1200--1003.1220 (Subpart L) Added.............................88362
1003.1300--1003.1320 (Subpart M) Added.............................88362
1003.1500--1003.1600 (Subpart O) Added.............................88364
1005.4 (c)(5) and (6) revised......................................88365

                                  2017

42 CFR
                                                                   82 FR
                                                                    Page
Chapter IV
482.58 (b) correctly revised.......................................32258
483.5 Correctly amended............................................32259
483.10 (i)(4) correctly amended....................................32259
483.15 (a)(7), (b)(2), (c)(2)(ii)(B), (iii)(F), (3)(iii), (4)(i), 
        (ii)(A), (B), (C), (D), (5) introductory text, 
        (d)(1)(iii), (iv), (2) correctly amended...................32259
483.45 (c)(5) correctly added......................................32259
483.50 (a)(2)(iii) correctly amended...............................32259
483.70 (i) heading correctly revised...............................32259
483.75 (g)(1)(iv) correctly amended................................32259
483.85 (b) correctly revised.......................................32259
483.90 (c) correctly revised.......................................32259
484.1--484.2 (Subpart A) Revised....................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
484.40--484.80 (Subpart B) Revised..................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
484.65 (d) introductory text amended; eff. 1-13-2018...............31732
484.100--484.115 (Subpart C) Revised................................4578
    Regulation at 82 FR 4578 eff. date delayed to 1-13-18..........31729
484.115 (a)(1) introductory text and (2) introductory text 
        amended; eff. 1-13-2018....................................31732
484.250 (a)(1) revised; (d), (e), and (f) added....................51752
484.305 Amended....................................................51752
485.58 Introductory text amended....................................4591
    Regulation at 82 FR 4591 eff. date delayed to 1-13-18..........31729
485.70 (c) and (e) amended..........................................4591
    Regulation at 82 FR 4591 eff. date delayed to 1-13-18..........31729
485.635 (a)(3)(vii) correctly amended..............................32260
485.645 (d)(2) correctly removed; (d)(3) through (10) correctly 
        redesignated as new (d)(2) through (9); (d)(1) and new 
        (d)(2) through (9) correctly revised.......................32260
486 Technical correction...........................................46138
486.312 (e) revised................................................38515
488 Authority citation revised.....................................38516
    Technical correction....................................46138, 46163
488.5 (a)(21) added................................................38516
488.30 (a) amended.................................................36635
488.56 (b) introductory text and (2) correctly amended.............32260
488.301 Amended....................................................36635
488.308 (e)(2) and (3) redesignated as (f)(1) and (2); new (f) 
        heading added; new (f)(1) introductory text revised........36635
488.314 (a)(1) revised.............................................36636
488.805 Amended.....................................................4591
    Regulation at 82 FR 4591 eff. date delayed to 1-13-18..........31729
489 Technical correction...........................................46138
489.52 (c)(2) introductory text revised............................38516
493.15 (c)(2) revised..............................................48773
495.4 Amended......................................................38516
    Corrected......................................................46143

[[Page 1175]]

495.22 Heading, (a), (b) heading, (1) heading, (c) heading, (1), 
        (e) heading, (8)(i)(A)(2)(ii), (ii)(A)(2)(ii), 
        (9)(ii)(A)(3), and (f) heading revised.....................38517
495.24 Heading, introductory text, (c) heading, (d) heading, 
        (6)(i)(B)(2)(i), (ii), (ii)(B)(1)(iv), (2)(i) and (ii) 
        revised....................................................38517
    Corrected......................................................46143
    (d)(6)(i)(B)(1)(iv) amended; (d) heading, (6)(i)(B)(2)(i), 
(ii), (ii)(B)(1)(iv), (2)(i), and (ii) revised.....................46143
495.40 (a) introductory text and (b) introductory text correctly 
        revised; (a)(2)(i)(H), (I), (b)(2)(i)(H) and (I) correctly 
        added; comment period extended................................36
    (b)(2)(i)(G) correctly revised.................................16742
    (a)(2)(i)(F) amended; (a)(2)(i)(G), (b)(2)(i)(F) introductory 
text and (G) introductory text revised.............................38518
495.102 (d)(5) redesignated as (d)(6); new (d)(5) and (7) added....38518
510.2 Amended...................................................610, 611
    Regulation at 82 FR 610 and 611 eff. date delayed to 3-21-17 
                                                                   10961
    Regulation at 82 FR 610 and 611 eff. date further delayed to 
5-20-17............................................................14464
    Regulation at 82 FR 611 eff. date delayed to 1-1-18............22895
    Amended; interim...............................................57103
510.105 (a) revised; interim.......................................57103
510.110 Added........................................................612
    Regulation at 82 FR 612 eff. date delayed to 5-20-17...........14464
    Regulation at 82 FR 612 eff. date delayed to 1-1-18............22895
510.115 Added; interim.............................................57103
510.120 Added........................................................612
    (b)(2) revised; (b)(3) and (c)(2) added..........................612
    Regulation at 82 FR 612 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 612 eff. date further delayed to 5-20-17 
                                                                   14464
    Regulation at 82 FR 612 eff. date delayed to 1-1-18............22895
    (b)(4) removed; (c) revised; (d) and (e) added; interim........57103
510.205 (a)(6) added.................................................613
    Regulation at 82 FR 613 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 613 eff. date further delayed to 5-20-17 
                                                                   14464
510.210 (b) revised; interim.......................................57104
510.300 Heading, (a) introductory text, (1), (2), (3), (b) 
        heading, (1) introductory text, (3), (5), (7) and (c) 
        revised; (a)(5) redesignated as (a)(6); new (a)(5) and 
        (b)(8) added.................................................613
    Regulation at 82 FR 613 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 613 eff. date further delayed to 5-20-17 
                                                                   14464
    (b)(6) revised; interim........................................57104
510.305 (e) introductory text, (1)(ii), (v), (f)(1)(i), (ii), (2), 
        (g)(2), (h)(6) and (i) revised; (h)(7) and (j) added.........613
    Regulation at 82 FR 613 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 613 eff. date further delayed to 5-20-17 
                                                                   14464
    (d)(1) and (e)(1)(i) revised; (k) added; interim...............57104
510.310 (a)(3) removed; (a)(4) and (d) redesignated as new (a)(3) 
        and (e); new (a)(4) and new (d) added; (a) introductory 
        text, (1), (2), (c) and new (e)(6) revised...................615
    Regulation at 82 FR 615 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 615 eff. date further delayed to 5-20-17 
                                                                   14464
510.315 (c) introductory text, (d) and (f) revised; (c)(1)(ix) and 
        (2)(ix) redesignated as (c)(1)(viii) and (2)(viii)...........615
    Regulation at 82 FR 615 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 615 eff. date further delayed to 5-20-17 
                                                                   14464
510.400 (c)(3) revised...............................................615
    Regulation at 82 FR 615 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 615 eff. date further delayed to 5-20-17 
                                                                   14464
510.405 (a)(1) and (b) revised.......................................616
    (b)(1) and (2) revised; (b)(4) added.............................616
    Regulation at 82 FR 616 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 616 eff. date further delayed to 5-20-17 
                                                                   14464

[[Page 1176]]

    Regulation at 82 FR 616 eff. date delayed to 1-1-18............22895
510.410 (b)(1) introductory text, (i) introductory text, (F), 
        (ii), (2)(i) through (v) and (b)(3) revised..................617
    Regulation at 82 FR 617 eff. date delayed to 5-20-17...........14464
    Regulation at 82 FR 617 eff. date delayed to 1-1-18............22895
    (b)(1)(i)(G) added; interim....................................57104
510.500 Revised......................................................617
    Regulation at 82 FR 617 eff. date delayed to 5-20-17...........14464
    Regulation at 82 FR 617 eff. date delayed to 1-1-18............22895
510.505 Revised......................................................620
    Regulation at 82 FR 620 eff. date delayed to 5-20-17...........14464
    Regulation at 82 FR 620 eff. date delayed to 1-1-18............22895
510.506 Added........................................................621
    Regulation at 82 FR 621 eff. date delayed to 5-20-17...........14464
    Regulation at 82 FR 621 eff. date delayed to 1-1-18............22895
510.515 (a)(2), (3), (b), (c) and (d) revised; (e) removed...........621
    Regulation at 82 FR 621 eff. date delayed to 5-20-17...........14464
    Regulation at 82 FR 621 eff. date delayed to 1-1-18............22895
510.605 (c)(2) revised; interim....................................57104
510.610 Revised......................................................622
    Regulation at 82 FR 622 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 622 eff. date further delayed to 5-20-17 
                                                                   14464
510.620 (a) revised..................................................622
    Regulation at 82 FR 622 eff. date delayed to 3-21-17...........10961
    Regulation at 82 FR 622 eff. date further delayed to 5-20-17 
                                                                   14464
512 Added............................................................622
    Regulation at 82 FR FR 622 eff. date delayed to 3-21-17........10961
    Regulation at 82 FR 622 eff. date further delayed to 5-20-17 
                                                                   14464
    Removed; interim...............................................57104
Chapter V
1000.10 Amended.....................................................4111
1000.20 Removed.....................................................4111
1000.30 Removed.....................................................4111
1001 Authority citation revised.....................................4111
1001.2 Amended......................................................4111
1001.101 (d)(1) and (2) revised.....................................4112
1001.102 (b)(7) removed; (b)(8) and (9) redesignated as new (b)(7) 
        and (8); (b)(1), new (b)(7), new (8), (c)(1) and (d) 
        revised; new (b)(9) added...................................4112
1001.201 (b)(2)(i), (vi), (3)(i) and (ii) revised; (b)(2)(vii) 
        added.......................................................4112
1001.301 Heading, (a), (b)(1), (2)(i), (ii), (vi) and (3)(i) 
        revised; (b)(2)(vii) and (viii) added.......................4112
1001.401 (a) introductory text, (1), (2), (c)(1), (2) introductory 
        text, (iv), (v) and (3) revised; (c)(2)(vi) added...........4113
1001.501 (b)(1), (3) and (4) revised; (c) added.....................4113
1001.601 (b)(3) and (4) revised.....................................4114
1001.701 (d)(2)(iv) and (3) revised.................................4114
1001.801 (a) introductory text revised; (c)(3)(ii) removed; 
        (c)(3)(iii) redesignated as new (c)(3)(ii)..................4114
1001.901 (c) added..................................................4114
1001.951 (b)(2) revised; (c) added..................................4114
1001.1001 (a) revised...............................................4114
1001.1051 Redesignated as 1001.1551.................................4115
1001.1101 (b)(4) revised; (b)(5) removed; (b)(6) redesignated as 
        new (b)(5)..................................................4115
1001.1201 (a) introductory text, (b)(3) and (4) revised; (b)(5) 
        removed.....................................................4115
1001.1301 (a)(1)(iii) and (3) revised...............................4115
1001.1501 (a)(1), (2) and (b) revised...............................4115
1001.1551 Redesignated from 1001.1051; (c)(1) revised...............4115
1001.1552 Added.....................................................4115
1001.1601 (b)(1)(iii) and (iv) revised; (b)(1)(v) removed...........4116
1001.1701 (c)(1)(iv) and (v) revised; (c)(1)(vi) removed............4116
1001.1801 (a) and (b) revised; (g) removed..........................4116
1001.1901 (b) revised...............................................4116
1001.2001 (b) and (c) revised.......................................4116
1001.2003 (a) and (b) revised.......................................4116
1001.3001 (a)(1) and (2) revised; (a)(3), (4) and (b) redesignated 
        as (b), (c) and (d).........................................4117

[[Page 1177]]

1001.3002 (a), (b) and (c) introductory text revised................4117
1001.3005 Heading and (a) introductory text revised.................4117
1002 Authority citation revised.....................................4117
1002.1 Revised......................................................4117
1002.2 Redesignated as 1002.3; added................................4118
1002.3 Redesignated as 1002.4; redesignated from 1002.2; (a) 
        revised.....................................................4118
1002.4 Redesignated from 1002.3; (c)(1) revised.....................4118
1002.5 Redesignated from 1002.100...................................4118
1002.6 Redesignated from 1002.211; revised..........................4118
1002.100 Redesignated as 1002.5.....................................4118
1002.203 (Subpart B) Heading revised................................4118
1002.203 Heading and (a) revised....................................4118
1002.210--1002.215 (Subpart C) Heading revised......................4118
1002.210 Heading revised............................................4118
1002.211 Redesignated as 1002.6; removed............................4118
1006 Authority citation revised.....................................4118
1006.1 (a) and (b) revised..........................................4118

                                  2018

42 CFR
                                                                   83 FR
                                                                    Page
Chapter IV
482 Policy statement...............................................55105
484 Policy statement...............................................55105
484 Authority citation revised.....................................56628
484.202 Amended....................................................56628
484.205 Revised....................................................56628
484.210 Removed....................................................56629
484.215 Heading revised; (d) introductory text amended; (f) added 
                                                                   56629
484.220 Heading and introductory text revised; (a) introductory 
        text amended...............................................56629
484.225 Heading and (a) revised; (b) and (c) amended; (d) added....56629
484.230 Revised....................................................56629
484.235 Revised....................................................56629
484.240 Revised....................................................56630
484.250 (a)(1) revised.............................................56630
484.320 (c) revised................................................56630
485 Policy statement...............................................55105
486 Authority citation revised.....................................56630
486.500--486.525 (Subpart I) Added.................................56630
488 Authority citation revised.....................................56631
488.5 (a)(17)(i) and (ii) amended; (a)(17)(iii) added..............56631
488.1000--488.1050 (Subpart L) Added...............................56631
495 Authority citation revised.....................................60096
495 Technical correction...........................................49836
495.4 Amended......................................................41706
495.4 Amended; interim.............................................60096
495.24 Introductory text, (c) heading, and (d) heading revised; 
        (e) added..................................................41707
495.24 (d)(6)(i)(B) and (8)(i)(B)(2) revised; interim..............60096
495.40 (b)(2)(vii) added...........................................41710
495.100 Amended....................................................41710
495.104 (b)(6) through (10) and (c)(5)(vi) through (x) added.......41710
495.200 Amended....................................................41711
495.211 (e)(4) added...............................................41711
495.316 (g)(2) revised.............................................41711
495.322 Revised....................................................41711
495.324 (b)(2), (3), and (d) revised...............................41711
495.332 (f)(3), (4), and (5) added; interim........................60096
498 Waiver.........................................................42037
498.3 (b)(20) added................................................16757
498.5 (n) added....................................................16757
510.2 Regulation at 82 FR 57103 confirmed..........................26610
510.105 Regulation at 82 FR 57103 confirmed........................26610
510.115 Regulation at 82 FR 57103 confirmed........................26610
510.120 Regulation at 82 FR 57103 confirmed........................26610
510.210 Regulation at 82 FR 57104 confirmed........................26610
510.300 Regulation at 82 FR 57104 confirmed........................26610
510.305 Regulation at 82 FR 57104 confirmed........................26610
510.410 Regulation at 82 FR 57104 confirmed........................26610
510.605 Regulation at 82 FR 57104 confirmed........................26610
512 Regulation at 82 FR 57104 confirmed............................26610

[[Page 1178]]

                                  2019

42 CFR
                                                                   84 FR
                                                                    Page
Chapter IV
482 Authority citation revised; eff. 11-29-19...............51817, 51882
482.13 (e)(5), (8)(ii), (10), (11), (12)(i), (14), and (g)(4)(ii) 
        revised; eff. 11-29-19.....................................51817
482.13 (d)(2) revised; eff. 11-29-19...............................51882
482.15 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, (d) introductory text, (1)(ii), and (2) 
        revised; (d)(1)(v) added; (g) introductory text, (1) and 
        (2) amended; eff. 11-29-19.................................51817
482.21 (b)(1) revised; (f) added; eff. 11-29-19....................51818
482.22 (c)(5)(i) and (ii) revised; (c)(5)(iii), (iv), and (v) 
        added; (d) removed; eff. 11-29-19..........................51818
482.23 (b) introductory text, (4), (6), (c)(1) introductory text, 
        and (3) revised; (b)(7) added; eff. 11-29-19...............51819
482.24 (c)(4)(i)(A) and (B) revised; (c)(4)(i)(C) added; eff. 11-
        29-19......................................................51819
482.27 (b)(7) revised; (b)(11) removed; eff. 11-29-19..............51819
482.42 Revised; eff. 11-29-19......................................51820
482.43 Revised; eff. 11-29-19......................................51882
482.51 (b)(1)(i) and (ii) revised; (b)(1)(iii) added; eff. 11-29-
        19.........................................................51821
482.58 (b)(4) removed; (b)(5) through (8) redesignated as new 
        (b)(4) through (7); (b)(1), new (4), new (5), and new (7) 
        revised; eff. 11-29-19; eff. 11-29-19......................51821
482.61 (d) revised; eff. 11-29-19..................................51821
482.68 Heading, introductory text, and (b) amended; eff. 11-29-19 
                                                                   51821
482.70 Amended; eff. 11-29-19......................................51821
482.72 Amended; eff. 11-29-19......................................51822
482.74 (a) introductory text, (1), (2), (3), and (b) introductory 
        text amended; eff. 11-29-19................................51822
482.78 Heading, introductory text, (a), and (b) amended; eff. 11-
        29-19......................................................51822
482.80 Heading, introductory text, (a), (b), (c) introductory 
        text, (1), (2), (d)(1), (2), (3), (4), and (5) amended; 
        eff. 11-29-19..............................................51822
482.82 Removed; eff. 11-29-19......................................51822
482.90--482.104 Undesignated center heading revised; eff. 11-29-19
                                                                   51822
482.90 Introductory text, (a)(1), (2), (3), (4), and (b) 
        introductory text amended; eff. 11-29-19...................51822
482.92 Introductory text, (a), and (b) amended; eff. 11-29-19......51822
482.94 Introductory text, (a) introductory text, (2), (b) 
        introductory text, (2), (3), (c) introductory text, (1) 
        introductory text, (i), (ii), (iii), (2), (3) introductory 
        text, (d) introductory text, (2), and (e) amended; eff. 
        11-29-19...................................................51822
482.96 Introductory text, (a), (b) introductory text, and (2) 
        amended; eff. 11-29-19.....................................51822
482.98 Introductory text, (a) heading, introductory text, (1), (b) 
        introductory text, (c) introductory, (2), (d) introductory 
        text, heading, (1), (2) introductory text, (3) 
        introductory text, (e), and (f) amended; eff. 11-29-19.....51822
482.100 Amended; eff. 11-29-19.....................................51822
482.102 Introductory text, (a) introductory text, (8), (b) 
        introductory text, (1), (4), (6), (9), (c) introductory 
        text, (1) introductory text, (2) introductory text, (i), 
        (ii), and (3) amended; eff. 11-29-19.......................51822
482.102 (a)(5) revised; eff. 11-29-19..............................51824
482.104 Heading, (a), (b), and (c) amended; eff. 11-29-19..........51824
483 Authority citation revised.....................................34735
483 Authority citation revised; eff. 11-29-19......................51824
483.70 (n) revised.................................................34735
483.73 (a)(4) and (d)(2) revised; eff. 11-29-19....................51824
483.475 (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....................51824

[[Page 1179]]

484.2 Amended; eff. 11-29-19.......................................51825
484.50 (a)(3) removed and (c)(7) introductory text revised; eff. 
        11-29-19...................................................51825
484.58 Added; eff. 11-29-19........................................51883
484.80 (c)(1) and (h)(3) revised; eff. 11-29-19....................51825
484.102 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, first (d)(1)(ii), and (d)(2) revised; 
        second (d)(1)(ii) redesignated as (d)(1)(iv); (d)(1)(v) 
        added; eff. 11-29-19.......................................51825
484.115 (a)(1) introductory text and (2) introductory text 
        amended; CFR correction....................................20810
484.202 Amended....................................................60644
484.205 (g)(2) and (h) heading revised; (g)(3), (4), (i), and (j) 
        added......................................................60644
484.225 (b) removed; (c) and (d) redesignated as new (b) and (c); 
        new (c) amended............................................60645
484.245 Added......................................................60645
484.250 Revised....................................................60646
484.315 Heading revised; (d) added.................................60646
485 Authority citation revised; eff. 11-29-19...............51826, 51883
485.66 Introductory text revised; eff. 11-29-19....................51826
485.68 (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....................51826
485.625 (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....................51826
485.627 (b)(1) removed; (b)(2) and (3) redesignated as (b)(1) and 
        (2); eff. 11-29-19.........................................51827
485.631 (d) added; eff. 11-29-19...................................51827
485.635 (a)(3)(vi) removed; (a)(3)(vii) redesignated as new 
        (a)(3)(vi); new (a)(3)(vi) and (4) revised; eff. 11-29-19 
                                                                   51827
485.635 (a)(3)(viii) added; eff. 11-29-19..........................51883
485.640 Added; eff. 11-29-19.......................................51827
485.641 Revised; eff. 11-29-19.....................................51828
485.642 Added; eff. 11-29-19.......................................51883
485.645 (d)(4) removed; (d)(5) through (9) redesignated as new 
        (d)(4) through (8); introductory text, (d)(1), new (4), 
        and new (7) revised; eff. 11-29-19.........................51828
485.727 (a) introductory text, (5), (b) introductory text, (c) 
        introductory text, (d) introductory text, (1)(ii), and (2) 
        revised; (d)(1)(v) added; eff. 11-29-19....................51829
485.914 (d)(1) and (2) revised; eff. 11-29-19......................51829
485.920 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, and (d) revised; eff. 11-29-19..........51829
486 Authority citation revised.....................................61492
486.104 (a) revised; eff. 11-29-19.................................51830
486.106 (a)(2) revised; eff. 11-29-19..............................51830
486.302 Amended....................................................61492
486.316 (a)(3) added; (b) revised..................................61492
486.360 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, (d) introductory text, (1)(ii), and 
        (2)(i) revised; (d)(1)(v) added; eff. 11-29-19.............51830
486.505 Amended....................................................60646
488.30 (a) amended; eff. 11-29-19..................................51831
488.61 (c) removed; (d) through (h) redesignated as new (c) 
        through (g); Heading, (a)(5), new (c), new (d), new (e) 
        heading, new (1) introductory text, (iv), (3), (f)(1)(i), 
        (ii), and (iii) revised; introductory text, (a) 
        introductory text, (2), and new (g)(1)(x) amended; eff. 
        11-29-19...................................................51831
489 Authority citation revised.....................................63204
489.2 (b)(10) and (c)(3) added; interim............................63204
489.10 (a) revised; interim........................................63204
489.13 (a)(2)(iii) added; interim..................................63204
489.53 (a)(3) revised; interim.....................................63204
491 Authority citation revised; eff. 11-29-19......................51832
491.9 (b)(4) revised; eff. 11-29-19................................51832
491.11 (a) revised; eff. 11-29-19..................................51832
491.12 (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....................51832

[[Page 1180]]

494 Authority citation revised; eff. 11-29-19......................51832
494.60 (d)(1), (2), and (4) revised; (d)(5), (e), and (f) added; 
        eff. 11-29-19..............................................51832
494.62 (a) introductory text, (4), (b) introductory text, (c) 
        introductory text, (d) introductory text, (1)(ii), and (2) 
        revised; (d)(1)(vii) added; eff. 11-29-19..................51833
495 Technical correction.....................................9460, 53603
495.4 Amended......................................................42615
495.24 (e)(1), (4)(iii), (5)(ii)(B), (iii), (iv), (v), and 
        (6)(ii)(B) revised.........................................42616
498 Authority citation revised..............................15844, 47857
498.2 Amended; interim.............................................63204
498.3 (b)(17) revised; eff. 11-4-19................................47857
498.5 (n)(1) revised...............................................15844
600 Policy statement...............................................59529
Chapter V
1001.952 (x)(5), (y)(4), (5) introductory text, (iii), (v), and 
        (11) amended; CFR correction...............................20810
1007 Revised.......................................................10713

                                  2020

42 CFR
                                                                   85 FR
                                                                    Page
Chapter IV
482 Authority citation revised.....................................25637
482 Policy statement...............................................47042
482 Technical correction...........................................52923
482.24 (d) added...................................................25637
482.27 (b)(3)(iii) and (4)(iii) amended............................72909
482.42 (e) added; interim..........................................54872
482.42 (e) revised; (f) added......................................86303
482.61 (d) revised; interim........................................19292
482.61 (f) added...................................................25637
483 Policy statement...................................................7
483.20 Regulation at 81 FR 61561 continued.........................55385
483.80 (g) added; interim..........................................27627
483.80 (h) added; interim..........................................54873
483.151 Regulation at 81 FR 61561 continued........................55385
484 Authority citation revised.....................................27627
484 Technical correction...........................................78748
484.2 Amended; interim.............................................27627
484.45 (c)(2) removed; (c)(3) and (4) redesignated as (c)(2) and 
        (3)........................................................70356
484.50 (d)(1) and (3) amended; interim.............................27628
484.55 (a)(1), (b)(3), and (d)(2) amended; interim.................27628
484.60 (a)(1), (2)(xvi), (b), and (c)(1) revised; (c)(3)(i), (ii), 
        (d)(1), and (2) amended; interim...........................27628
484.75 Introductory text and (b)(3) amended; interim...............27628
484.80 (g)(2)(i) amended; interim..................................27628
484.110 Introductory text and (a)(1) revised.......................70356
484.205 (h)(1)(ii), (iii), (2) introductory text, (i)(2)(i), and 
        (j)(2)(i) amended; interim.................................27628
484.235 (a)(1), (3), (b)(1), and (3) amended; interim..............27628
484.265 Revised....................................................59026
484.315 (b) revised; interim.......................................27628
485 Authority citation revised.....................................25638
485.638 (d) added..................................................25638
485.639 (c)(1)(vii) amended........................................72910
485.640 (d) added; interim.........................................54873
485.640 (d) revised; (e) added.....................................86304
486 Technical correction.............................................224
486.302 Amended....................................................77947
486.302 Amended; eff. in part 7-31-22..............................77947
486.316 (a) through (c) revised; (f) and (g) added.................77947
486.318 (a)(4), (b)(4), (c)(3), and (d) through (f) added..........77948
486.328 (a) introductory text and (7) amended; (a)(4) removed......77949
486.348 (d) added..................................................77949
488 Policy statement...................................................7
488.307 Regulation at 81 FR 61561 continued........................55385
488.408 Regulation at 81 FR 61561 continued........................55385
488.438 Regulation at 81 FR 61561 continued........................55385
488.446 Regulation at 81 FR 61561 continued........................55385
488.447 Added; interim.............................................54873
488.725 Regulation at 81 FR 61561 continued........................55385
488.845 Regulation at 81 FR 61561 continued........................55385
489 Technical correction...............................................8
493 Policy statement...................................................7
493 Authority citation revised.....................................54873
493.2 Amended; interim.............................................54873
493.41 Added; interim..............................................54873
493.555 (c)(6) added; interim......................................54873

[[Page 1181]]

493.1100 (a) added; interim........................................54873
493.1804 (c)(1) revised; interim...................................54874
493.1834 (d)(2)(iii) added; interim................................54874
493.1834 Regulation at 81 FR 61561 continued.......................55385
495 Technical correction...........................................78748
495.4 Amended......................................................59026
495.20 (e)(5)(iii) and (l)(11)(ii)(C)(1) amended...................59026
495.24 (e)(5)(iii)(B) and (6)(ii)(B) heading revised...............59026
495.104 (c)(5)(viii)(B), (C), and (D) revised......................59027
498 Technical correction...............................................8
510 Authority citation revised..............................19292, 71198
510.2 Amended; interim......................................19292, 71198
510.200 (a) amended; interim.......................................19292
510.200 (a) and (d)(6) revised; interim............................71199
510.300 (a) introductory text, (1)(i), (iii), (2), (3), 
        (b)(1)(iii), (2)(iii), (8), (c)(1), (2), and (3)(iii) 
        revised; interim...........................................71199
510.305 (k)(3) and (4) added; interim..............................19292
510.305 (b), (d)(1) introductory text, (e) introductory text, (1) 
        introductory text, (i), (ii), (iii), (v)(A) introductory 
        text, (3), (B) introductory text, (3), (C), (f)(1)(ii), 
        (g)(1), (3), (h) introductory text, (5), (6), (i), (j), 
        and (k)(4) revised; interim................................71199
510.315 (a), (b) introductory text, and (d) revised; interim.......71201
510.400 (a) introductory text, (b)(2) introductory text, (i), (ii) 
        introductory text, and (3)(v) introductory text revised; 
        (b)(3)(vi) added; interim..................................71201
512 Added; eff. 11-30-20...........................................61362
512 Technical correction...........................................77404
512.205 Amended....................................................86304
512.210 (a) and (c) revised........................................86304
512.217 (c)(3) introductory text revised...........................86304
512.220 (b) revised................................................86304
512.245 (a) revised................................................86305
512.255 (c)(10) revised............................................86305
512.285 (d) revised................................................86305
513 Added; interim.................................................76250
600 Notification...................................................49264
600.125 (b) revised; (c) added; interim............................27629
Chapter V
1001.952 (h)(5)(vi) and (vii) revised; (h)(5)(viii) added; eff. in 
        part 1-1-22................................................76730
1001.952 (h)(6) through (9), (cc), and (dd) added..................76730
1001.952 (g)(5), (6), (ee) through (kk) added; (g) undesignated 
        text, (y) note, and (bb) note designated as (g)(7), (14), 
        and (bb)(3); (d), (g) introductory text, (1), (3), (4), 
        new (g)(7), (y) introductory text, (1), (11), 
        (bb)(1)(iv)(B) and (2)(iii) revised; (y)(2) amended; 
        (y)(3), (7), (13) removed..................................77887
1003.110 Amended...................................................77894
1004.40 Amended....................................................72910
1008.36 Amended....................................................72910

                                  2021

  (Regulations published from January 1, 2021, through October 1, 2021)

42 CFR
                                                                   86 FR
                                                                    Page
Chapter IV
482 Technical correction....................................11428, 33902
482.42 Correction: Regulation at 85 FR 86304 instruction amended 
                                                                   33902
483.20 Regulation at 81 FR 61563 continued to 9-6-22...............50263
483.80 (d) heading and (g)(1)(viii) revised; (d)(3) and (g)(1)(ix) 
        added; (g)(1)(vii) amended; interim........................26335
483.90 (d) revised.................................................42524
483.151 Regulation at 81 FR 61563 continued to 9-6-22..............50263
483.430 (f) added; interim.........................................26336
483.460 (a)(4) redesignated as (a)(5); new (a)(4) added; interim 
                                                                   26336
485 Technical correction....................................11428, 33902
485.640 Correction: Regulation at 85 FR 86304 instruction amended 
                                                                   33902
486.302 Regulation at 85 FR 77947 eff. date delayed to 3-20-21......7814
486.316 Regulation at 85 FR 77947 eff. date delayed to 3-20-21......7814
486.318 Regulation at 85 FR 77948 eff. date delayed to 3-20-21......7814
486.328 Regulation at 85 FR 77947 eff. date delayed to 3-20-21......7814

[[Page 1182]]

488.307 Regulation at 81 FR 61563 continued to 9-6-22..............50263
488.408 Regulation at 81 FR 61563 continued to 9-6-22..............50263
488.438 Regulation at 81 FR 61563 continued to 9-6-22..............50263
488.446 Regulation at 81 FR 61563 continued to 9-6-22..............50263
488.725 Regulation at 81 FR 61563 continued to 9-6-22..............50263
488.845 Regulation at 81 FR 61563 continued to 9-6-22..............50263
489 Authority citation revised.....................................42525
489.20 (s)(13) through (16) revised; (s)(17) redesignated as 
        (s)(18); new (s)(17) added.................................42525
493.1834 Regulation at 81 FR 61564 continued to 9-6-22.............50263
495.4 Amended......................................................45521
495.24 (e)(1)(i), (4)(ii), (5)(ii)(B), (iii)(B), (6)(ii) 
        introductory text, (8)(ii) introductory text, (A), (iii) 
        introductory text, (A)(1), (2), (D), and (E) revised; 
        (e)(4)(iv) and (6)(ii)(C) added; (e)(7)(ii) introductory 
        text, (A), and (B) amended.................................45522
495.40 (b) introductory text and (2)(i)(I) introductory text 
        revised; (b)(2)(i)(J) added................................45523
510 Authority citation revised.....................................23569
510 Technical correction...........................................33135
510.2 Amended......................................................23569
510.100 (a) revised................................................23570
510.105 (a)(3) added...............................................23570
510.120 (a) introductory text revised..............................23570
510.200 (b)(15), (d)(7), and (e)(5) added; (a), (c), (d)(4) 
        introductory text, (6), (e)(2), (3) introductory text, and 
        (4) introductory text revised..............................23570
510.205 (a)(6)(iii) revised........................................23571
510.210 (a) and (b)(1)(ii) revised.................................23571
510.300 (a)(6) and (b)(1)(iv) through (vi) added; (a)(2) through 
        (4), (b)(2)(iii), (5), and (c)(3)(iii) revised.............23571
510.301 Added......................................................23571
510.305 (f)(1)(iv) through (vi), (l), and (m) added; (b), (d) 
        heading, (e) introductory text, and (i) revised............23572
510.310 (b)(4)(i) and (5) removed; (b)(4)(ii), through (iv), (6), 
        and (7) redesignated as (b)(4)(i), (ii), (iii), (5), and 
        (6); new (b)(4)(iii) and new (6) revised...................23573
510.315 (d), (f)(1), and (2) revised...............................23573
510.400 (b)(2)(i) and (ii) introductory text amended; (b)(4) added
                                                                   23574
510.400 Correction: (b)(4)(ii)(A) amended..........................36229
510.405 (b)(1) and (3) revised.....................................23574
510.500 (c)(4)(i) and (ii) revised.................................23575
510.505 (b)(8)(i) and (ii) revised.................................23575
510.506 (b)(8) revised.............................................23575
510.600 (b)(1) amended.............................................23575
510.610 (a) revised; (b)(1) amended................................23575
512 Technical correction....................................11428, 33902
512.205 Correction: Regulation at 85 FR 86304 instruction amended 
                                                                   33902
512.210 Correction: Regulation at 85 FR 86304 instruction amended 
                                                                   33902
512.217 Correction: Regulation at 85 FR 86304 instruction amended 
                                                                   33902
512.220 Correction: Regulation at 85 FR 86304 instruction amended 
                                                                   33902
512.245 Correction: Regulation at 85 FR 86305 instruction amended 
                                                                   33902
512.255 Correction: Regulation at 85 FR 86305 instruction amended 
                                                                   33902
512.285 Correction: Regulation at 85 FR 86305 instruction amended 
                                                                   33902
600 Policy statement...............................................35615
Chapter V
1000.1 (Subpart A) Added............................................5755
1000.1 (Subpart A) Regulation at 86 FR 5755 eff. date delayed to 
        3-22-22....................................................15404
1001.952 Regulation at 85 FR 76730 delayed to 1-1-23...............15133
1001.952 Regulation at 86 FR 7815 delayed to 1-1-23................15133
1001.952 Regulation at 85 FR 76730 eff. date delayed to 1-1-23 in 
        part.......................................................10181

[[Page 1183]]

1001.952 Correction: (h)(vi) through (viii) removed; (h)(6) 
        through (9), (cc), and (dd) added; section amended..........7815
1001.952 Correction: (h)(5)(vi) and (vii) revised; (h)(5)(viii) 
        added; eff. 1-1-22..........................................7815


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