[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2000 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

                    42


                    Parts 400 to 429

                    Revised as of October 1, 2000

                    Public Health





                    Containing a Codification of documents 
                    of general applicability and future effect


                    As of October 1, 2000

                    With Ancillaries
          
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration


                    As a Special Edition of the Federal Register



[[Page ii]]

                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2000



               For sale by U.S. Government Printing Office
 Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328



[[Page iii]]




                            Table of Contents



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

  Title 42:
          Chapter IV--Health Care Financing Administration, 
          Department of Health and Human Services                    3
  Finding Aids:
      Material Approved for Incorporation by Reference........     875
      Table of CFR Titles and Chapters........................     877
      Alphabetical List of Agencies Appearing in the CFR......     895
      Redesignation Tables....................................     905
      List of CFR Sections Affected...........................     933



[[Page iv]]


      


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

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

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

[[Page v]]



                               EXPLANATION

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

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

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

LEGAL STATUS

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

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, October 1, 2000), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
info@fedreg.nara.gov.

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call 202-512-1800, 
M-F, 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2233, 24 hours 
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Customer Service call 202-512-1803.

ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, The United States 
Government Manual, the Federal Register, Public Laws, Public Papers, 
Weekly Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format at www.access.gpo.gov/
nara (``GPO Access''). For more information, contact Electronic 
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Phone 202-512-1530, or 888-293-6498 (toll-free). E-mail, 
gpoaccess@gpo.gov.
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.nara.gov/fedreg. The NARA 
site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

October 1, 2000.



[[Page ix]]



                               THIS TITLE

    Title 42--Public Health is composed of three volumes. The parts in 
these volumes are arranged in the following order: Parts 1-399, parts 
400-429 and part 430 to end. The first volume (parts 1-399) contains 
current regulations issued under chapter I--Public Health Service (HHS). 
The second volume (parts 400-429) includes regulations issued under 
chapter IV--Health Care Financing Administration (HHS) and the third 
volume (part 430 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, 2000.

    The OMB control numbers for the Health Care Financing Administration 
appear in Sec. 400.310 of chapter IV. For the convenience of the user 
subpart C consisting of Secs. 400.300-400.310 is reprinted in the 
Finding Aids section of the third volume.

    Redesignation tables appear in the Finding Aids section of all 
volumes.

    For this volume, Linda L. Jones was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

[[Page x]]





[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                  (This book contains parts 400 to 429)

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

chapter iv--Health Care Financing Administration, Department 
  of Health and Human Services..............................         400

[[Page 3]]



                         CHAPTER IV--HEALTH CARE
                        FINANCING ADMINISTRATION,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES




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


  Editorial Note: Nomenclature changes affecting chapter IV appear at 53 
FR 6634, Mar. 2, 1988; 53 FR 47201, Nov. 22, 1988; 56 FR 8852, Mar. 1, 
1991 and 62 FR 46037, Aug. 29, 1997.

                    SUBCHAPTER A--GENERAL PROVISIONS
Part                                                                Page
400             Introduction; definitions...................           5
401             General administrative requirements.........           9
402             Civil money penalties, assessments, and 
                    exclusions..............................          22
403             Special programs and projects...............          35
                     SUBCHAPTER B--MEDICARE PROGRAM
405             Federal health insurance for the aged and 
                    disabled................................          60
406             Hospital insurance eligibility and 
                    entitlement.............................         167
407             Supplementary medical insurance (SMI) 
                    enrollment and entitlement..............         183
408             Premiums for supplementary medical insurance         193
409             Hospital insurance benefits.................         207
410             Supplementary medical insurance (SMI) 
                    benefits................................         233
411             Exclusions from Medicare and limitations on 
                    Medicare payment........................         276
412             Prospective payment systems for inpatient 
                    hospital services.......................         331
413             Principles of reasonable cost reimbursement; 
                    payment for end-stage renal disease 
                    services; prospectively determined 
                    payment rates for skilled nursing 
                    facilities..............................         423
414             Payment for Part B medical and other health 
                    services................................         545
415             Services furnished by physicians in 
                    providers, supervising physicians in 
                    teaching settings, and residents in 
                    certain settings........................         571
416             Ambulatory surgical services................         589

[[Page 4]]

417             Health maintenance organizations, 
                    competitive medical plans, and health 
                    care prepayment plans...................         598
418             Hospice care................................         692
419             Prospective payment system for hospital 
                    outpatient department services..........         709
420             Program integrity: Medicare.................         720
421             Intermediaries and carriers.................         730
422             Medicare+Choice program.....................         743
424             Conditions for Medicare payment.............         845

[[Page 5]]





                    SUBCHAPTER A--GENERAL PROVISIONS



PART 400--INTRODUCTION; DEFINITIONS--Table of Contents




Subpart A   [Reserved]

                         Subpart B--Definitions

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

 Subpart C--OMB Control Numbers for Approved Collections of Information

400.300  Scope.
400.310  Display of currently valid OMB control numbers.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh) and 44 U.S.C. Chapter 35.

Subpart A--[Reserved]



                         Subpart B--Definitions



Sec. 400.200  General definitions.

    In this chapter, unless the context indicates otherwise--
    Act means the Social Security Act, and titles referred to are titles 
of that Act.
    Administrator means the Administrator, Health Care Financing 
Administration.
    ALJ stands for administrative law judge.
    Area means the geographical area within the boundaries of a State, 
or a State or other jurisdiction, designated as constituting an area 
with respect to which a Professional Standards Review Organization or a 
Utilization and Quality Control Peer Review Organization has been or may 
be designated.
    CMP stands for competitive medical plan.
    Conditions of participation includes requirements for participation 
as the latter term is used in part 483 of this chapter.
    Condition level deficiencies includes deficiencies with respect to 
``level A requirements'' as the latter term is used in parts 442 and 483 
of this chapter.
    CORF stands for comprehensive outpatient rehabilitation facility.
    CFR stands for Code of Federal Regulations.
    CY stands for calendar year.
    DAB stands for Departmental Appeals Board.
    Department means the Department of Health and Human Services (HHS), 
formerly the Department of Health, Education, and Welfare.
    ESRD stands for end-stage renal disease.
    FDA stands for the Food and Drug Administration.
    FQHC means Federally qualified health center.
    FR stands for Federal Register.
    FY stands for fiscal year.
    HCFA stands for Health Care Financing Administration.
    HCPP stands for health care prepayment plan.
    HHS stands for the Department of Health and Human Services.
    HHA stands for home health agency.
    HMO stands for health maintenance organization.
    ICF stands for intermediate care facility.
    ICF/MR stands for intermediate care facility for the mentally 
retarded.
    Medicaid means medical assistance provided under a State plan 
approved under title XIX of the Act.
    Medicare means the health insurance program for the aged and 
disabled under title XVIII of the Act.
    NCD stands for national coverage determination.
    OASDI stands for the Old Age, Survivors, and Disability Insurance 
program under title II of the Act.
    OIG stands for the Department's Office of the Inspector General.
    Peer review organization means an organization that has a contract 
with HCFA, under part B of title XI of the Act, to perform utilization 
and quality control review of the health care furnished, or to be 
furnished, to Medicare beneficiaries.
    PRO stands for peer review organization.
    QDWI stands for Qualified Disabled and Working Individual.
    QMB stands for Qualified Medicare Beneficiary.

[[Page 6]]

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

[48 FR 12534, Mar. 25, 1983, as amended at 49 FR 7206, Feb. 27, 1984; 50 
FR 15326 and 15358, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985; 51 FR 
43197, Dec. 1, 1986; 52 FR 27764, July 23, 1987; 56 FR 8852, Mar. 1, 
1991; 56 FR 38077, Aug. 12, 1991; 57 FR 24975, June 12, 1992; 57 FR 
55912, Nov. 25, 1992; 63 FR 35065, June 26, 1998; 63 FR 52611, Oct. 1, 
1998; 63 FR 68690, Dec. 14, 1998]



Sec. 400.202  Definitions specific to Medicare.

    As used in connection with the Medicare program, unless the context 
indicates otherwise--
    Beneficiary means a person who is entitled to Medicare benefits.
    Carrier means an entity that has a contract with HCFA to determine 
and make Medicare payments for Part B benefits payable on a charge basis 
and to perform other related functions.
    Critical access hospital (CAH) means a facility designated by HFCA 
as meeting the applicable requirements of section 1820 of the Act and of 
subpart F of part 485 of this chapter.
    Entitled means that an individual meets all the requirements for 
Medicare benefits.
    Essential access community hospital (EACH) means a hospital 
designated by HCFA as meeting the applicable requirements of section 
1820 of the Act and of subpart G of part 412 of this chapter, as in 
effect on September 30, 1997.
    GME stands for graduate medical education.
    Hospital insurance benefits means payments on behalf of, and in rare 
circumstances directly to, an entitled individual for services that are 
covered under Part A of title XVIII of the Act.
    Intermediary means an entity that has a contract with HCFA to 
determine and make Medicare payments for Part A or Part B benefits 
payable on a cost basis and to perform other related functions.
    Medicare Part A means the hospital insurance program authorized 
under Part A of title XVIII of the Act.
    Medicare Part B means the supplementary medical insurance program 
authorized under Part B of title XVIII of the Act.
    National coverage determination (NCD) means a national policy 
determination

[[Page 7]]

regarding the coverage status of a particular service, that HCFA makes 
under section 1862(a)(1) of the Act, and publishes as a Federal Register 
notice or HCFA Ruling. (The term does not include coverage changes 
mandated by statute.)
    Nonparticipating supplier means a supplier that does not have an 
agreement with HCFA to participate in Part B of Medicare in effect on 
the date of the service.
    Participating supplier means a supplier that has an agreement with 
HCFA to participate in Part B of Medicare in effect on the date of the 
service.
    Payment on an assignment-related basis means payment for Part B 
services--
    (1) To a physician or other supplier that accepts assignment from 
the beneficiary, in accordance with Sec. 424.55 or Sec. 424.56 of this 
chapter;
    (2) To a physician or other supplier after the beneficiary's death, 
in accordance with Sec. 424.64(c)(1) of this chapter; or
    (3) To an entity that pays the physician or other supplier under a 
health benefit plan, in accordance with Sec. 424.66 of this chapter.
    Provider means a hospital, a CAH, a skilled nursing facility, a 
comprehensive outpatient rehabilitation facility, a home health agency, 
or a hospice that has in effect an agreement to participate in Medicare, 
or a clinic, a rehabilitation agency, or a public health agency that has 
in effect a similar agreement but only to furnish outpatient physical 
therapy or speech pathology services, or a community mental health 
center that has in effect a similar agreement but only to furnish 
partial hospitalization services.
    Railroad retirement benefits means monthly benefits payable to 
individuals under the Railroad Retirement Act of 1974 (45 U.S.C. 
beginning at section 231).
    Services means medical care or services and items, such as medical 
diagnosis and treatment, drugs and biologicals, supplies, appliances, 
and equipment, medical social services, and use of hospital, CAH, or SNF 
facilities.
    Supplementary medical insurance benefits means payment to or on 
behalf of an entitled individual for services covered under Part B of 
title XVIII of the Act.
    Supplier means a physician or other practitioner, or an entity other 
than a provider, that furnishes health care services under Medicare.

[48 FR 12534, Mar. 25, 1983, as amended at 48 FR 56024, Dec. 16, 1983; 
49 FR 3658, Jan. 30, 1984; 51 FR 43197, Dec. 1, 1986; 52 FR 27764, July 
23, 1987; 55 FR 24567, June 18, 1990; 56 FR 8852, Mar. 1, 1991; 58 FR 
30666, May 26, 1993; 59 FR 6576, Feb. 11, 1994; 60 FR 63175, Dec. 8, 
1995; 62 FR 46025, Aug. 29, 1997; 62 FR 59098, Oct. 31, 1997; 63 FR 
35065, June 26, 1998]



Sec. 400.203  Definitions specific to Medicaid.

    As used in connection with the Medicaid program, unless the context 
indicates otherwise--
    Applicant means an individual whose written application for Medicaid 
has been submitted to the agency determining Medicaid eligibility, but 
has not received final action. This includes an individual (who need not 
be alive at the time of application) whose application is submitted 
through a representative or a person acting responsibly for the 
individual.
    Federal financial participation (FFP) means the Federal Government's 
share of a State's expenditures under the Medicaid program.
    FMAP stands for the Federal medical assistance percentage, which is 
used to calculate the amount of Federal share of State expenditures for 
services.
    Medicaid agency or agency means the single State agency 
administering or supervising the administration of a State Medicaid 
plan.
    Nursing facility (NF), effective October 1, 1990, means an SNF or an 
ICF participating in the Medicaid program.
    Provider means any individual or entity furnishing Medicaid services 
under a provider agreement with the Medicaid agency.
    Recipient means an individual who has been determined eligible for 
Medicaid.
    Services means the types of medical assistance specified in section 
1905(a) of the Act and defined in subpart A of part 440 of this chapter.

[[Page 8]]

    State means the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa 
and the Northern Mariana Islands.
    State plan or the plan means a comprehensive written commitment by a 
Medicaid agency, submitted under section 1902(a) of the Act, to 
administer or supervise the administration of a Medicaid program in 
accordance with Federal requirements.

[48 FR 12534, Mar. 25, 1983, as amended at 50 FR 33029, Aug. 16, 1985; 
56 FR 8852, Mar. 1, 1991; 57 FR 29155, June 30, 1992]



 Subpart C--OMB Control Numbers for Approved Collections of Information

    Source: 49 FR 4477, Feb. 7, 1984, unless otherwise noted.



Sec. 400.300  Scope.

    This subpart collects and displays control numbers assigned by the 
Office of Management and Budget (OMB) to collections of information 
contained in HCFA regulations, in accordance with OMB's regulations for 
controlling paperwork burdens on the public, 5 CFR part 1320. HCFA 
intends that the subpart comply with the requirements of section 3507(f) 
of the Paperwork Reduction Act of 1980, 44 U.S.C. chapter 35 which 
requires that agencies shall not engage in a ``collection of 
information'' without obtaining a control number from OMB.



Sec. 400.310  Display of currently valid OMB control numbers.

------------------------------------------------------------------------
                                                             Current OMB
Sections in 42 CFR that contain collections of information  control Nos.
------------------------------------------------------------------------
403.510...................................................    0938--0641
405.509...................................................    0938--0666
405.512...................................................    0938--0008
405.2112, 405.2123, 405.2134, 405.2136-405.2140, 405.2171.    0938--0386
409.43....................................................    0938--0365
410.105...................................................    0938--0267
411.25, 411.32............................................    0938--0564
411.54....................................................    0938--0558
411.165...................................................    0938--0564
411.404, 411.406..........................................    0938--0465
411.408...................................................    0938--0566
412.42....................................................    0938--0666
412.92....................................................    0938--0477
412.105...................................................    0938--0456
412.230, 412.232, 412.234, 412.236, 412.254, 412.260,         0938--0573
 412.266, 412.278.........................................
415.60....................................................    0938--0301
415.162...................................................    0938--0301
416.43....................................................    0938--0506
416.47....................................................    0938--0266
                                                                     and
                                                              0938--0506
417.126...................................................    0938--0472
417.436, 417.801..........................................    0938--0610
418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74....    0938--0302
418.30, 418.82, 418.83, 418.96, 418.100...................    0938--0475
418.96, 418.100...........................................    0938--0302
421.117...................................................    0938--0542
424.3.....................................................    0938--0008
424.5, 424.7, 424.20......................................    0938--0454
424.22....................................................    0938--0489
424.32, 424.34............................................    0938--0008
431.17....................................................    0938--0467
431.50, 431.52, 431.55....................................    0938--0247
431.107...................................................    0938--0610
431.306...................................................    0938--0467
431.625...................................................    0938--0247
431.630...................................................    0938--0445
431.800...................................................    0938--0247
431.806, 431.830, 431.432, 431.834, 431.836...............    0938--0438
432.50....................................................    0938--0459
433.36, 433.37............................................    0938--0247
433.68, 433.74............................................    0938--0618
433.110, 433.112-433.114, 433.116, 433.117, 433.119-          0938--0247
 433.121, 433.123, 433.127, 433.130, 433.131, 433.135.....
433.138...................................................    0938--0502
                                                              0938--0553
                                                                     and
                                                              0938--0555
433.139...................................................    0938--0459
                                                              0938--0554
                                                                     and
                                                              0938--0555
434.27....................................................    0938--0572
434.28....................................................    0938--0610
435.1, 435.910, 435.919, 435.920, 435.940, 435.945,           0938--0247
 435.948, 435.952, 435.953, 435.955, 435.960, 435.965,
 435.1003, 441.11, 441.15, 441.20.........................
441.56, 441.58, 441.60, 441.61............................    0938--0354
441.302...................................................    0938--0449
441.303...................................................    0938--0272
                                                                     and
                                                              0938--0449
441.351, 441.352, 441.353, 441.356, 441.365...............    0938--0613
442.505...................................................    0938--0366
447.31....................................................    0938--0287
447.45, 447.50, 447.51, 447.52............................    0938--0247
447.53....................................................    0938--0429
447.55....................................................    0938--0247
447.253...................................................    0938--0366
                                                              0938--0523
                                                                     and
                                                              0938--0556
447.255...................................................    0938--0193
447.272, 447.299..........................................    0938--0618
447.302, 447.331, 447.332, 447.333........................    0938--0247
456.80....................................................    0938--0247
456.654...................................................    0938--0445
456.700, 456.705, 456.709, 456.711, 456.712...............    0938--0659
462.102, 462.103..........................................    0938--0526
466.70, 466.72, 466.74....................................    0938--0445
466.78....................................................    0938--0445
                                                                     and
                                                              0938--0665
466.80, 466.94............................................    0938--0445
473.18, 473.34, 473.36, 473.42............................    0938--0443
476.104, 476.105, 476.116, 476.134........................    0938--0426

[[Page 9]]

 
481.61....................................................    0938--0328
482.12, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43,       0938--0328
 482.53, 482.56, 482.57, 482.60, 482.62...................
483.10....................................................    0938--0610
483.410, 483.420, 483.440, 483.460, 483.470...............    0938--0366
484.1, 484.2..............................................    0938--0365
484.10....................................................    0938--0365
                                                                     and
                                                              0938--0610
484.12, 484.14, 484.16, 484.18, 484.30, 484.32, 484.34,       0938--0365
 484.36, 484.48, 484.52...................................
485.56, 485.58, 485.60, 485.64, 485.66....................    0938--0267
                                                                     and
                                                              0938--0538
485.709, 485.711, 485.717, 485.719, 485.721, 487.723,         0938--0336
 485.725, 485.727.........................................
486.104, 486.106, 486.110.................................    0938--0338
486.155, 486.161, 486.163.................................    0938--0336
488.10....................................................    0938--0646
488.18....................................................    0938--0667
488.26....................................................    0938--0646
489.20....................................................    0938--0564
                                                                     and
                                                              0938--0667
489.24....................................................    0938--0334
                                                              0938--0663
                                                                     and
                                                              0938--0667
489.102...................................................    0938--0610
491.9, 491.10.............................................    0938--0334
493.35, 493.37, 493.39, 493.43, 493.45, 493.47, 493.49,
 493.51, 493.53,..........................................
493.55, 493.60, 493.61, 493.62, 493.63....................    0938--0612
493.614, 493.633, 494.634.................................    0938--0607
493.801-493.1285, 493.1425, 493.1701, 493.1703, 493.1705,     0938--0612
 493.1707, 493.1709, 493.1711, 493.1713, 493.1715,
 493.1717, 493.1719, 493.1721, 493.1775, 493.1776,
 493.1777, 493.1780, 493.2001.............................
494.52, 494.54, 494.56, 494.58, 494.64....................    0938--0608
498.22, 498.40, 498.58, 498.82............................    0938--0508
1004.40, 1004.50, 1004.60, 1004.70........................    0938--0444
------------------------------------------------------------------------


[60 FR 50445, Sept. 29, 1995, as amended at 60 FR 63188, Dec. 8, 1995]



PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents




Subpart A   [Reserved]

                Subpart B--Confidentiality and Disclosure

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

Subparts C-E-- [Reserved]

               Subpart F--Claims Collection and Compromise

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

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh). Subpart F is also issued under the authority of the 
Federal Claims Collection Act (31 U.S.C. 3711).

Subpart A   [Reserved]



                Subpart B--Confidentiality and Disclosure

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



Sec. 401.101  Purpose and scope.

    (a) The regulations in this subpart:
    (1) Implement section 1106(a) of the Social Security Act as it 
applies to the Health Care Financing Administration (HCFA). The rules 
apply to information obtained by officers or employees of HCFA in the 
course of administering title XVIII of the Social Security Act 
(Medicare), information obtained by Medicare intermediaries or carriers 
in the course of carrying out agreements

[[Page 10]]

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



Sec. 401.102  Definitions.

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



Sec. 401.105  Rules for disclosure.

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

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

[[Page 11]]



Sec. 401.106  Publication.

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

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



Sec. 401.108  HCFA rulings.

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

[48 FR 22924, May 23, 1983]



Sec. 401.110  Publications for sale.

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



Sec. 401.112  Availability of administrative staff manuals.

    All HCFA administrative staff manuals and instructions to staff 
personnel which contain policies, procedures, or interpretations that 
affect the public are available for inspection and copying. A complete 
listing of such materials is published in HCFA Rulings. These manuals 
are generally not printed in a sufficient quantity to permit sale or 
other general distribution to the public. Selected material is 
maintained at Social Security Administration district offices and field 
offices and may be inspected there. See Secs. 401.130 and 401.132 for a 
listing of this material.



Sec. 401.116  Availability of records upon request.

    (a) General. In addition to the records made available pursuant to 
Secs. 401.106, 401.108, 401.110 and 401.112, HCFA will, upon request 
made in accordance with this subpart, make identified records available 
to any person, unless they are exempt from disclosure under the 
provisions of section 552(b) of title 5, United States Code (see 
Sec. 401.126), or any other provision of law.

[[Page 12]]

    (b) Misappropriation, alteration, or destruction of records. No 
person may remove any record made available to him for inspection or 
copying under this part, from the place where it is made available. In 
addition, no person may steal, alter, mutilate, obliterate, or destroy 
in whole or in part, such a record. See sections 641 and 2071 of title 
18 of the United States Code.



Sec. 401.118  Deletion of identifying details.

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



Sec. 401.120  Creation of records.

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



Sec. 401.126  Information or records that are not available.

    (a) Specific exemptions from disclosure. Pursuant to paragraph (b) 
of 5 U.S.C. 552, certain classes of records are exempt from disclosure. 
For some examples of the kinds of materials which are exempt, see 
subpart F of the public information regulation of the Department of 
Health and Human Services (45 CFR part 5) and the appendix to that 
regulation.
    (b) Materials exempt from disclosure by statute. Pursuant to 
paragraph (b)(3) of 5 U.S.C. 552, as amended, which exempts from the 
requirement for disclosure matters that are exempted from disclosure by 
statute, provided that such statute requires that the matters be 
withheld from the public in such a manner as to leave no discretion on 
the issue, or establishes particular criteria for withholding or refers 
to particular types of matter to be withheld:
    (1) Reports described in sections 1106 (d) and (e) of the Social 
Security Act shall not be disclosed, except in accordance with the 
provisions of sections 1106 (d) and (e). Sections 1106 (d) and (e) 
provide for public inspection of certain official reports dealing with 
the operation of the health programs established by titles XVIII and XIX 
of the Social Security Act (Medicare and Medicaid), but require that 
program validation survey reports and other formal evaluations of 
providers of services shall not identify individual patients, individual 
health care practitioners, or other individuals. Section 1106(e) further 
requires that none of the reports shall be made public until the 
contractor or provider whose performance is being evaluated has had a 
reasonable opportunity to review that report and to offer comments. See 
Sec. 401.133 (b) and (c);
    (2)(i) Except as specified in paragraph (b)(2)(ii) of this section, 
HCFA may not disclose any accreditation survey or any information 
directly related to the survey (including corrective action plans) made 
by and released to it by the Joint Commission on Accreditation of 
Healthcare Organizations, the American Osteopathic Association or any 
other national accreditation organization that meets the requirements of 
Sec. 488.6 or Sec. 493.506 of this chapter. Materials that are 
confidential include accreditation letters and accompanying 
recommendations and comments prepared by an accreditation organization 
concerning the entities it surveys.
    (ii) Exceptions.
    (A) HCFA may release the accreditation survey of any home health 
agency; and
    (B) HCFA may release the accreditation survey and other information 
directly related to the survey (including corrective action plans) to 
the extent the survey and information relate to an enforcement action 
(for example, denial of payment for new admissions, civil money 
penalties, temporary management and termination) taken by HCFA; and
    (3) Tax returns and return information defined in section 6103 of 
the Internal Revenue Code, as amended by the Tax Reform Act of 1976, 
shall not be disclosed except as authorized by the Internal Revenue 
Code.

[[Page 13]]

    (c) Effect of exemption. Neither 5 U.S.C. 552 nor this regulation 
directs the withholding of any record or information, except to the 
extent of the prohibitions in paragraph (b) of this section. Except for 
material required to be withheld under the statutory provisions 
incorporated in paragraph (b) of this section or under another statute 
which meets the standards in 5 U.S.C. 552(b)(3), materials exempt from 
mandatory disclosure will nevertheless be made available when this can 
be done consistently with obligations of confidentiality and 
administrative necessity. The disclosure of materials or records under 
these circumstances in response to a specific request, however, is of no 
precedent force with respect to any other request.

[46 FR 55696, Nov. 12, 1981, as amended at 58 FR 61837, Nov. 23, 1993]



Sec. 401.128  Where requests for records may be made.

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

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

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

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

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



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

    (a) Materials available for inspection. The following are available 
or will be made available for inspection at the social security district 
offices and branch offices:
    (1) Compilation of the Social Security Laws.
    (2) The Public Information Regulation of the Department of Health 
and Human Services (45 CFR part 5).

[[Page 14]]

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

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

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



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

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



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

    Except as otherwise provided for in Sec. 488.325 of this chapter for 
SNFs, the following must be made available to the public under the 
conditions specified:
    (a) Statements of deficiencies and survey reports on providers of 
services prepared by State agencies. (1) Statements

[[Page 15]]

of deficiencies based upon official survey reports prepared after 
January 31, 1973, by a State agency pursuant to its agreement entered 
into under section 1864 of the Social Security Act and furnished to 
HCFA, which relate to a State agency's findings on the compliance of a 
health care institution or facility with the applicable provisions in 
section 1861 of the Act and with the regulations, promulgated pursuant 
to those provisions, dealing with health and safety of patients in those 
institutions and facilities; and (2) State agency survey reports. The 
statement of deficiencies or report and any pertinent written statements 
furnished by the institution or facility on the statement of 
deficiencies shall be disclosed within 90 days following the completion 
of the survey by the State agency, but not to exceed 30 days following 
the receipt of the report by HCFA. (See Sec. 401.130(b)(17)) for places 
where statements of deficiencies, reports, and pertinent written 
statements will be available.)
    (b) HCFA reports on providers of services. Upon request in writing, 
official reports and other formal evaluations (including followup 
reviews), excluding references to internal tolerance rules and practices 
contained therein, internal working papers or other informal memoranda, 
prepared and completed after January 31, 1973, which relate to the 
performance of providers of services under Medicare: Provided, That no 
information identifying individual patients, physicians, or other 
practitioners, or other individuals shall be disclosed under this 
paragraph. Those reports and other evaluations shall be disclosed within 
30 days following the final preparation thereof by HCFA during which 
time the providers of services shall be afforded a reasonable 
opportunity to offer comments, and there shall be disclosed with those 
reports and evaluations any pertinent written statements furnished HCFA 
by those providers on those reports and evaluations.
    (c) Contractor performance review reports. Upon request in writing, 
official contractor performance review reports and other formal 
evaluations (including followup reviews), excluding references to 
internal tolerance rules and practices contained therein, internal 
working papers or other informal memoranda, prepared and completed after 
January 31, 1973, which relate to the evaluation of the performance of 
(1) intermediaries and carriers under their agreements entered into 
pursuant to sections 1816 and 1842 of the Social Security Act and (2) 
State agencies under their agreements entered into pursuant to section 
1864 of the Act (including comparative evaluations of the performance of 
those intermediaries, carriers, and State agencies). The latest Contract 
Performance Review Report pertaining to a particular intermediary or 
carrier, prepared prior to February 1, 1973, may also be disclosed to 
any person upon request in writing. Those reports and evaluations shall 
be disclosed within 30 days following their final preparation by HCFA 
(or 30 days following the request therefor, in the case of the contract 
performance review report prepared prior to February 1, 1973), during 
which time those intermediaries, carriers, and State agencies, as the 
case may be, shall be afforded a reasonable opportunity to offer 
comments, and there shall be disclosed with those reports and 
evaluations any pertinent written statements furnished HCFA by those 
intermediaries, carriers, on State agencies or those reports and 
evaluations.
    (d) Accreditation surveys. Upon written request, HCFA will release 
the accreditation survey and related information from an accreditation 
organization meeting the requirements of Sec. 488.5, Sec. 488.6 or 
Sec. 493.506 of this chapter to the extent the survey and information 
relate to an enforcement action taken (for example, denial of payment 
for new admission, civil money penalties, temporary management and 
termination) by HCFA;
    (e) Upon written request, HCFA will release the accreditation survey 
of any home health agency.

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



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

    (a) Except as provided in paragraph (b) of this section, the 
following information may be released to an officer or

[[Page 16]]

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



Sec. 401.135  Release of Medicare information to the public.

    The following shall be made available to the public under the 
conditions specified:
    (a) Information as to amounts paid to providers and other 
organizations and facilities for services to beneficiaries under title 
XVIII of the Act: Provided, That no information identifying any 
particular beneficiaries shall be disclosed under this paragraph.
    (b) The name of any provider of services or other person furnishing 
services to Medicare beneficiaries who--
    (1) Has been found by a Federal court to have been guilty of 
submitting false claims in connection with Medicare; or
    (2) Has been found by a carrier or intermediary, after consultation 
with a professional medical association functioning external to program 
administration or, if appropriate, the State

[[Page 17]]

medical authority, to have been engaged in a pattern of furnishing 
services to beneficiaries which are substantially in excess of their 
medical needs; except that the name of any provider or other person 
shall not be disclosed pursuant to a finding under this paragraph (b)(2) 
of this section, unless that provider or other person has first been 
afforded a reasonable opportunity to offer evidence on his behalf.
    (c) Upon request in writing, cost reports submitted by providers of 
services pursuant to section 1815 of the Act to enable the Secretary to 
determine amounts due the providers.



Sec. 401.136  Requests for information or records.

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



Sec. 401.140  Fees and charges.

    (a) Statement of policy. It is HCFA's policy to comply with certain 
requests for information services without charge. Except as otherwise 
determined pursuant to paragraph (c) of this section, fees will be 
charged for the following services with respect to all other requests 
for information from records which are reasonably identified by the 
requesters:
    (1) Reproduction, duplication, or copying of records;
    (2) Searches for records; and
    (3) Certification or authentication of records.
    (b) Fee schedules. The fee schedule is as follows:
    (1) Search for records. Three dollars per hour: Provided, however, 
That no charge will be made for the first half hour.
    (2) Reproduction, duplication, or copying of records. Ten cents per 
page where such reproduction can be made by commonly available 
photocopying machines. The cost of reproducing records which cannot be 
so photocopied will be determined on an individual basis at actual cost.

[[Page 18]]

    (3) Certification or authentication of records. Three dollars per 
certification or authentication.
    (4) Forwarding materials to destination. Any special arrangements 
for forwarding which are requested shall be charged at actual cost; 
however, no charge will be made for postage.
    (5) No charge will be made when the total amount does not exceed 
five dollars.
    (c) Waiver or reduction of fees. Waiver or reduction of the fees in 
paragraph (b) of this section may be made upon a determination that such 
waiver or reduction is in the public interest because furnishing the 
information can be considered as primarily benefiting the general 
public. Such determination may be made by the appropriate officer or 
employee identified in Sec. 401.144.
    (d) Sale of documents. On occasion, a previously printed document 
may be available for sale to the public; the cost of supplying the 
document is one cent per page unless the document is available for sale 
from the Superintendent of Documents, in which case the price shall be 
that determined by the Superintendent.



Sec. 401.144  Denial of requests.

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



Sec. 401.148  Administrative review.

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



Sec. 401.152  Court review.

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

[[Page 19]]

Subparts C-E--[Reserved]



               Subpart F--Claims Collection and Compromise

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



Sec. 401.601  Basis and scope.

    (a) Basis. This subpart implements for HCFA the Federal Claims 
Collection Act (FCCA) of 1966 (31 U.S.C. 3711), and conforms to the 
regulations (4 CFR parts 101-105) issued jointly by the General 
Accounting Office and the Department of Justice that generally prescribe 
claims collection standards and procedures under the FCCA for the 
Federal government.
    (b) Scope. Except as provided in paragraphs (c) through (f) of this 
section, the regulations in this subpart describe HCFA's procedures and 
standards for the collection of claims in any amount, and the compromise 
of, or the suspension or termination of collection action on, all claims 
for money or property that do not exceed $100,000 or such higher amount 
as the Attorney General may from time to time prescribe, exclusive of 
interest, arising under any functions delegated to HCFA by the 
Secretary.
    (c) Amount of claim. HCFA refers all claims that exceed $100,000 or 
such higher amount as the Attorney General may from time to time 
prescribe, exclusive of interest, to the Department of Justice or the 
General Accounting Office for the compromise of claims, or the 
suspension or termination of collection action.
    (d) Related regulations--(1) Department regulations. DHHS 
regulations applicable to HCFA that generally implement the FCCA for the 
Department are located at 45 CFR part 30. These regulations apply only 
to the extent HCFA regulations do not address a situation.
    (2) HCFA regulations. The following regulations govern specific debt 
management situations encountered by HCFA and supplement this subpart:
    (i) Claims against Medicare beneficiaries for the recovery of 
overpayments are covered in 20 CFR 404.515.
    (ii) Adjustments in Railroad Retirement or Social Security benefits 
to recover Medicare overpayments to individuals are covered in 
Secs. 405.350--405.358 of this chapter.
    (iii) Claims against providers, physicians, or other suppliers of 
services for overpayments under Medicare and for assessment of interest 
are covered in Secs. 405.377 and 405.378 of this chapter, respectively.
    (iv) Claims against beneficiaries for unpaid hospital insurance or 
supplementary medical insurance premiums under Medicare are covered in 
Sec. 408.110 of this chapter.
    (v) State repayment of Medicaid funds by installments is covered in 
Sec. 430.48 of this chapter.
    (e) Collection and compromise under other statutes and at common 
law. The regulations in this subpart do not--
    (1) Preclude disposition by HCFA of claims under statutes, other 
than the FCCA, that provide for the collection or compromise of a claim, 
or suspension or termination of collection action.
    (2) Affect any rights that HCFA may have under common law as a 
creditor.
    (f) Fraud. The regulations in this subpart do not apply to claims in 
which there is an indication of fraud, the presentation of a false 
claim, or misrepresentation on the part of a debtor or any other party 
having an interest in the claim. HCFA forwards these claims to the 
Department of Justice for disposition under 4 CFR 105.1.
    (g) Enforced collection. HCFA refers claims to the Department of 
Justice for enforced collection through litigation in those cases which 
cannot be compromised or on which collection action cannot be suspended 
or terminated in accordance with this subpart or the regulations issued 
jointly by the Attorney General and the Comptroller General.

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



Sec. 401.603  Definitions.

    For purposes of this subpart--
    Claim means any debt owed to HCFA.
    Debtor means any individual, partnership, corporation, estate, trust 
or other legal entity against which HCFA has a claim.

[[Page 20]]



Sec. 401.605  Omissions not a defense.

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



Sec. 401.607  Claims collection.

    (a) General policy. HCFA recovers amounts of claims due from 
debtors, including interest where appropriate, by--
    (1) Direct collections in lump sums or in installments; or
    (2) Offsets against monies owed to the debtor by the Federal 
government where possible.
    (b) Collection in lump sums. Whenever possible, HCFA attempts to 
collect claims in full in one lump sum. However, if HCFA determines that 
a debtor is unable to pay the claim in one lump sum, HCFA may instead 
enter into an agreement to accept regular installment payments.
    (c) Collection in installments. Generally, HCFA requires that all 
claims to be satisfied by installment payments must be liquidated in 
three years or less. If unusual circumstances exist, such as the 
possibility of debtor insolvency, an installment agreement that extends 
beyond three years may be approved.
    (1) Debtor request. If a debtor desires to repay a claim in 
installments, the debtor must submit--
    (i) A request to HCFA; and
    (ii) Any information required by HCFA to make a decision regarding 
the request.
    (2) HCFA decision. HCFA will determine the number, amount and 
frequency of installment payments based on the information submitted by 
the debtor and on other factors such as--
    (i) Total amount of the claim;
    (ii) Debtor's ability to pay; and
    (iii) Cost to HCFA of administering an installment agreement.
    (d) Collection by offset. (1) HCFA may offset, where possible, the 
amount of a claim against the amount of pay, compensation, benefits or 
other monies that a debtor is receiving or is due from the Federal 
government.
    (2) Under regulations at Sec. 405.350--405.358 of this chapter, HCFA 
may initiate adjustments in program payments to which an individual is 
entitled under title II of the Act (Federal Old Age, Survivors, and 
Disability Insurance Benefits) or under the Railroad Retirement Act of 
1974 (45 U.S.C. 231) to recover Medicare overpayments.

[48 FR 39064, Aug. 29, 1983, as amended at 61 FR 49271, Sept. 19, 1996; 
61 FR 63748, Dec. 2, 1996]



Sec. 401.613  Compromise of claims.

    (a) Amount of compromise. HFCA requires that the amount to be 
recovered through a compromise of a claim must--
    (1) Bear a reasonable relation to the amount of the claim; and
    (2) Be recoverable through enforced collection procedures.
    (b) General factors. After considering the bases for a decision to 
compromise a claim under paragraph (c) of this section, HCFA may further 
consider factors such as--
    (1) The age and health of the debtor if the debtor is an individual;
    (2) Present and potential income of the debtor; and
    (3) Whether assets have been concealed or improperly transferred by 
the debtor.
    (c) Basis for compromise. Bases on which HCFA may compromise a claim 
include the following--
    (1) Inability to pay. HCFA may compromise a claim if it determines 
that the debtor, or the estate of a deceased debtor, does not have the 
present or prospective ability to pay the full amount of the claim 
within a reasonable time.
    (2) Litigative probabilities. HCFA may compromise a claim if it 
determines that it would be difficult to prevail in a case before a 
court of law as a result of the legal issues involved or inability of 
the parties to agree to the facts of the case. The amount that HCFA 
accepts in compromise under this provision will reflect--
    (i) The likelihood that HCFA would have prevailed on the legal 
question(s) involved;
    (ii) Whether and to what extent HCFA would have obtained a full or 
partial recovery of a judgment, depending on the availability of 
witnesses, or

[[Page 21]]

other evidentiary support for HCFA's claim; and
    (iii) The amount of court costs that would be assessed to HCFA.
    (3) Cost of collecting the claim. HCFA may compromise a claim if it 
determines that the cost of collecting the claim does not justify the 
enforced collection of the full amount. In this case, HCFA may adjust 
the amount it accepts as a compromise to allow an appropriate discount 
for the costs of collection it would have incurred but for the 
compromise.
    (d) Enforcement policy. HCFA may compromise statutory penalties, 
forfeitures, or debts established as an aid to enforcement or to compel 
compliance, if it determines that its enforcement policy, in terms of 
deterrence and securing compliance both present and future, is 
adequately served by acceptance of the compromise amount.



Sec. 401.615  Payment of compromise amount.

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



Sec. 401.617  Suspension of collection action.

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



Sec. 401.621  Termination of collection action.

    (a) General factors. After considering the bases for a decision to 
terminate collection action under paragraph (b) of this section, HCFA 
may further consider factors such as--
    (1) The age and health of the debtor if the debtor is an individual;
    (2) Present and potential income of the debtor; and
    (3) Whether assets have been concealed or improperly transferred by 
the debtor.
    (b) Basis for termination of collection action. Bases on which HCFA 
may terminate collection action on a claim include the following--
    (1) Inability to collect a substantial amount of the claim. HCFA may 
terminate collection action if it determines

[[Page 22]]

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



Sec. 401.623  Joint and several liability.

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



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

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



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




                      Subpart A--General Provisions

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

            Subpart B--Civil Money Penalties and Assessments

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

Subpart C--Exclusions [Reserved]

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

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



                      Subpart A--General Provisions



Sec. 402.1  Basis and scope.

    (a) Basis. This part is based on the sections of the Act that are 
specified in paragraph (c) of this section.
    (b) Scope. This part--
    (1) Provides for the imposition of civil money penalties, 
assessments, and exclusions against persons that violate the provisions 
of the Act specified in

[[Page 23]]

paragraph (c), (d), or (e) of this section; and
    (2) Sets forth the appeal rights of persons subject to penalties, 
assessments, or exclusion and the procedures for reinstatement following 
exclusion.
    (c) Civil money penalties. HCFA or OIG may impose civil money 
penalties against any person or other entity specified in paragraphs 
(c)(1) through (c)(30) of this section under the identified section of 
the Act. The authorities that also permit imposition of an assessment or 
exclusion are noted in the applicable paragraphs.
    (1) Sections 1833(h)(5)(D) and 1842(j)(2)--Any person that knowingly 
and willfully, and on a repeated basis, bills for a clinical diagnostic 
laboratory test, other than on an assignment-related basis. This 
provision includes tests performed in a physician's office but excludes 
tests performed in a rural health clinic. (This violation may also 
include an assessment and cause exclusion.)
    (2) Section 1833(i)(6)--Any person that knowingly and willfully 
presents, or causes to be presented, a bill or request for payment for 
an intraocular lens inserted during or after cataract surgery for which 
the Medicare payment rate includes the cost of acquiring the class of 
lens involved.
    (3) Section 1833(q)(2)(B)--Any entity that knowingly and willfully 
fails to provide information about a referring physician, including the 
physician's name and unique physician identification number for the 
referring physician, when seeking payment on an unassigned basis. (This 
violation, if it occurs in repeated cases, may also cause an exclusion.)
    (4) Sections 1834(a)(11)(A) and 1842(j)(2)--Any durable medical 
equipment supplier that knowingly and willfully charges for a covered 
service that is furnished on a rental basis after the rental payments 
may no longer be made (except for maintenance and servicing) as provided 
in section 1834(a)(7)(A). (This violation may also include an assessment 
and cause exclusion.)
    (5) Sections 1834(a)(18)(B) and 1842(j)(2)--Any nonparticipating 
durable medical equipment supplier that knowingly and willfully, in 
violation of section 1834(a)(18)(A), fails to make a refund to Medicare 
beneficiaries for a covered service for which payment is precluded due 
to an unsolicited telephone contact from the supplier. (This violation 
may also include an assessment and cause exclusion.)
    (6) Sections 1834(b)(5)(C) and 1842(j)(2)--Any nonparticipating 
physician or supplier that knowingly and willfully charges a Medicare 
beneficiary more than the limiting charge, as specified in section 
1834(b)(5)(B), for radiologist services. (This violation may also 
include an assessment and cause exclusion.)
    (7) Sections 1834(c)(4)(C) and 1842(j)(2)--Any nonparticipating 
physician or supplier that knowingly and willfully charges a Medicare 
beneficiary more than the limiting charge, as specified in section 
1834(c)(4)(B), for mammography screening. (This violation may also 
include an assessment and cause exclusion.)
    (8) Sections 1834(h)(3) and 1842(j)(2)--Any supplier of prosthetic 
devices, orthotics, and prosthetics that knowingly and willfully charges 
for a covered prosthetic device, orthotic, or prosthetic that is 
furnished on a rental basis after the rental payment may no longer be 
made (except for maintenance and servicing). (This violation may also 
include an assessment and cause exclusion.)
    (9) Section 1834(j)(2)(A)(iii)--Any supplier of durable medical 
equipment, including a supplier of prosthetic devices, prosthetics, 
orthotics, or supplies, that knowingly and willfully distributes a 
certificate of medical necessity in violation of section 
1834(j)(2)(A)(i) or fails to provide the information required under 
section 1834(j)(2)(A)(ii).
    (10) Sections 1834(j)(4) and 1842(j)(2)--
    (i) Any supplier of durable medical equipment, including a supplier 
of prosthetic devices, prosthetics, orthotics, or supplies, that 
knowingly and willfully fails to make refunds in a timely manner to 
Medicare beneficiaries for services billed other than on an assignment-
related basis if--
    (A) The supplier does not possess a Medicare supplier number;
    (B) The service is denied in advance under section 1834(a)(15); or

[[Page 24]]

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

[[Page 25]]

    (B) Imposes a charge for completing and submitting the standard 
claims form.
    (ii) These violations, if they occur in repeated cases, may also 
cause exclusion.
    (20) Section 1862(b)(5)(C)--Any employer (other than a Federal or 
other governmental agency) that, before October 1, 1998, willfully or 
repeatedly fails to provide timely and accurate information requested 
relating to an employee's group health insurance coverage.
    (21) Section 1862(b)(6)(B)--Any entity that knowingly, willfully, 
and repeatedly--
    (i) Fails to complete a claim form relating to the availability of 
other health benefit plans in accordance with section 1862(b)(6)(A); or
    (ii) Provides inaccurate information relating to the availability of 
other health benefit plans on the claim form.
    (22) Section 1877(g)(5)--Any person that fails to report information 
required by HHS under section 1877(f) concerning ownership, investment, 
and compensation arrangements. (This violation may also include an 
assessment and cause exclusion.)
    (23) Sections 1879(h), 1834(a)(18), and 1842(j)(2)--
    (i) Any durable medical equipment supplier, including a supplier of 
prosthetic devices, prosthetics, orthotics, or supplies, that knowingly 
and willfully fails to make refunds in a timely manner to Medicare 
beneficiaries for services billed on an assignment-related basis if--
    (A) The supplier did not possess a Medicare supplier number;
    (B) The service is denied in advance under section 1834(a)(15) of 
the Act; or
    (C) The service is determined not to be payable under section 
1834(a)(17)(b) because of unsolicited telephone contacts.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (24) Section 1882(a)(2)--Any person that issues a Medicare 
supplemental policy that has not been approved by the State regulatory 
program or does not meet Federal standards on and after the effective 
date in section 1882(p)(1)(C). (This violation may also include an 
assessment and cause exclusion.)
    (25) Section 1882(p)(8)--Any person that sells or issues Medicare 
supplemental policies, on or after July 30, 1992, that fail to conform 
to the NAIC or Federal standards established under section 1882(p). 
(This violation may also include an assessment and cause exclusion.)
    (26) Section 1882(p)(9)(C)--
    (i) Any person that sells a Medicare supplemental policy and--
    (A) Fails to make available for sale the core group of basic 
benefits when selling other Medicare supplemental policies with 
additional benefits; or
    (B) Fails to provide the individual, before the sale of the policy, 
an outline of coverage describing the benefits provided by the policy.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (27) Section 1882(q)(5)(C)--
    (i) Any person that fails to--
    (A) Suspend a Medicare supplemental policy at the policyholder's 
request, if the policyholder applies for and is determined eligible for 
medical assistance, and the policyholder provides notice within 90 days 
of the eligibility determination; or
    (B) Automatically reinstate the policy as of the date of termination 
of medical assistance if the policyholder loses eligibility for medical 
assistance and the policyholder provides notice within 90 days of loss 
of eligibility.
    (ii) These violations may also include an assessment and cause 
exclusion.
    (28) Section 1882(r)(6)(A)--Any person that fails to provide refunds 
or credits as required by section 1882(r)(1)(B). (This violation may 
also include an assessment and cause exclusion.)
    (29) Section 1882(s)(3)--
    (i) Any issuer of a Medicare supplemental policy that--
    (A) Does not waive any time periods applicable to preexisting 
conditions, waiting periods, elimination periods, or probationary 
periods if the time periods were already satisfied under a preceding 
Medicare supplemental policy; or
    (B) Denies a policy, conditions the issuance or effectiveness of the 
policy, or discriminates in the pricing of the policy based on health 
status or other

[[Page 26]]

criteria as specified in section 1882(s)(2)(A).
    (ii) These violations may also include an assessment and cause 
exclusion.
    (30) Section 1882(t)(2)--
    (i) Any issuer of a Medicare supplemental policy that--
    (A) Fails substantially to provide medically necessary services to 
enrollees seeking the services through the issuer's network of entities;
    (B) Imposes premiums on enrollees in excess of the premiums approved 
by the State;
    (C) Acts to expel an enrollee for reasons other than nonpayment of 
premiums; or
    (D) Does not provide each enrollee at the time of enrollment with 
the specific information provided in section 1882(t)(1)(E)(i) or fails 
to obtain a written acknowledgment from the enrollee of receipt of the 
information (as required by section 1882(t)(1)(E)(ii)).
    (ii) These violations may also include an assessment and cause 
exclusion.
    (d) Assessments. HCFA or OIG may impose assessments in addition to 
civil money penalties for violations of the following statutory 
sections:
    (1) Section 1833: Paragraph (h)(5)(D).
    (2) Section 1834: Paragraphs (a)(11)(A), (a)(18)(B), (b)(5)(C), 
(c)(4)(C), (h)(3), and (j)(4).
    (3) Section 1842: Paragraphs (k), (l)(3), (m)(3), and (n)(3).
    (4) Section 1848: Paragraph (g)(1)(B).
    (5) Section 1877: Paragraph (g)(5).
    (6) Section 1879: Paragraph (h).
    (7) Section 1882: Paragraphs (a)(2), (p)(8), (p)(9)(C), (q)(5)(C), 
(r)(6)(A), (s)(3), and (t)(2).
    (e) Exclusions. (1) HCFA or OIG may exclude any person from 
participation in the Medicare program on the basis of any of the 
following violations of the statute:
    (i) Section 1833: Paragraphs (h)(5)(D) and, in repeated cases, 
(q)(2)(B).
    (ii) Section 1834: Paragraphs (a)(11)(A), (a)(18)(B), (b)(5)(C), 
(c)(4)(C), (h)(3), and (j)(4).
    (iii) Section 1842: Paragraphs (b)(18)(B), (k), (l)(3), (m)(3), 
(n)(3), and, in repeated cases, (p)(3)(B).
    (iv) Section 1848: Paragraphs (g)(1)(B), (g)(3)(B), and, in repeated 
cases, (g)(4)(B)(ii).
    (v) Section 1877: Paragraph (g)(5).
    (vi) Section 1879: Paragraph (h).
    (vii) Section 1882: Paragraphs (a)(2), (p)(8), (p)(9)(C), (q)(5)(C), 
(r)(6)(A), (s)(3), and (t)(2).
    (2) HCFA or OIG must exclude from participation in the Medicare 
program any of the following, under the identified section of the Act:
    (i) Section 1834(a)(17)(C)--Any supplier of durable medical 
equipment and supplies that are covered under section 1834(a)(13) that 
knowingly contacts Medicare beneficiaries by telephone regarding the 
furnishing of covered services in violation of section 1834(a)(17)(A) 
and whose conduct establishes a pattern of prohibited contacts as 
described under section 1834(a)(17)(A).
    (ii) Section 1834(h)(3)--Any supplier of prosthetic devices, 
orthotics, and prosthetics that knowingly contacts Medicare 
beneficiaries by telephone regarding the furnishing of prosthetic 
devices, orthotics, or prosthetics in the same manner as in the 
violation under section 1834(a)(17)(A) and whose conduct establishes a 
pattern of prohibited contacts in the same manner as described in 
section 1834(a)(17)(C).
    (f) Responsible persons. (1) If HCFA or OIG determines that more 
than one person is responsible for any of the violations described in 
paragraph (c) or paragraph (d) of this section, it may impose a civil 
money penalty or a civil money penalty and assessment against any one of 
those persons or jointly and severally against two or more of those 
persons. However, the aggregate amount of the assessments collected may 
not exceed the amount that could be assessed if only one person were 
responsible.
    (2) A principal is liable for penalties and assessments for the 
actions of his or her agent acting within the scope of the agency.
    (g) Time limits. Neither HCFA nor OIG initiates an action to impose 
a civil money penalty, assessment, or proceeding to exclude a person 
from participation in the Medicare program unless it begins the action 
within 6 years from the date on which the claim was presented, the 
request for payment was made, or the incident occurred.

[[Page 27]]



Sec. 402.3  Definitions.

    For purposes of this part:
    Assessment means the amount described in Sec. 402.107 and includes 
the plural of that term.
    Assignment-related basis means that the claim submitted by a 
physician, supplier or other person is paid on the basis of an 
assignment, whereby the physician, supplier or other person agrees to 
accept the Medicare payment as payment in full for the services 
furnished to the beneficiary and is precluded from charging the 
beneficiary more than the deductible and coinsurance based upon the 
approved Medicare fee amount. Additional obligations, including 
obligations to make refunds in certain circumstances, are established at 
section 1842(b)(3) of the Act.
    Claim means an application for payment for a service for which the 
Medicare or Medicaid program may pay.
    Covered means that a service is described as reasonable and 
necessary for the diagnosis or treatment of illness or injury or to 
improve the functioning of a malformed body member. A service is not 
covered if it is specifically identified as excluded from Medicare Part 
B coverage or is not a defined Medicare Part B benefit.
    Exclusion means the temporary or permanent barring of a person or 
other entity from participation in the Medicare or State health care 
program and that services furnished or ordered by that person are not 
paid for under either program.
    General Counsel means the General Counsel of HHS or his or her 
designees.
    Knowingly or knowingly and willfully means that a person, with 
respect to information--
    (1) Has actual knowledge of the information;
    (2) Acts in deliberate ignorance of the truth or falsity of the 
information; or
    (3) Acts in reckless disregard of the truth or falsity of the 
information; and
    (4) No proof of specific intent is required.
    Medicare supplemental policy means a policy guaranteeing that a 
health plan will pay a policyholder's coinsurance and deductible and 
will cover other limitations on payment imposed under title XVIII of the 
Act and will provide additional health plan or non-Medicare coverage for 
services up to a predefined benefit limit.
    NAIC stands for the National Association of Insurance Commissioners.
    Nonparticipating describes a physician, supplier, or other person 
(excluding any provider of services) that, at the time of furnishing the 
services to Medicare Part B beneficiaries, is not a participating 
physician or supplier.
    Participating describes a physician or supplier (excluding any 
provider of services) that, before the beginning of any given year, 
enters into an agreement with HHS that provides that the physician or 
supplier will accept payment under the Medicare program on an 
assignment-related basis for all services furnished to Medicare Part B 
beneficiaries.
    Penalty means the amount described in Sec. 402.105 and includes the 
plural of that term.
    Person means an individual, trust or estate, partnership, 
corporation, professional association or corporation, or other entity, 
public or private.
    Physicians' services means the following Medicare covered 
professional services:
    (1) Surgery, consultation, home, office and institutional calls, and 
other professional services performed by physicians.
    (2) Services and supplies furnished ``incident to'' a physician's 
professional services.
    (3) Outpatient physical and occupational therapy services.
    (4) Diagnostic x-ray tests and other diagnostic tests (excluding 
clinical diagnostic laboratory tests).
    (5) X-ray, radium, and radioactive isotope therapy, including 
materials and services of technicians.
    (6) Antigens prepared by a physician.
    Radiologist service means radiology services performed only by, or 
under the direction of, a physician who is certified, or eligible to be 
certified, by the American Board of Radiology or for whom radiology 
services account for at least 50 percent of the total amount of charges 
made under part B of title XVIII of the Act.
    Request for payment means an application submitted by a person to 
any person for payment for a service.

[[Page 28]]

    Respondent means the person upon which HCFA or OIG has imposed, or 
proposes to impose, a civil money penalty, assessment, or exclusion.
    Service includes--
    (1) Any item, device, medical supply, or service claimed to have 
been furnished to a patient and listed in an itemized claim for program 
payment; or
    (2) In the case of a claim based on costs, any entry or omission in 
a cost report, books of account or other documents supporting the claim.
    State includes the District of Columbia, Puerto Rico, the Virgin 
Islands, Guam, American Samoa, the Northern Mariana Islands, and the 
Trust Territory of the Pacific Islands.
    Timely basis means that the adjustment to a bill or a refund is 
considered ``on a timely basis'' if the physician, supplier, or other 
person makes the adjustment or refund to the appropriate party no later 
than 30 days after the date the physician, supplier, or other person is 
notified by the Medicare Part B contractor of the violation and the 
requirement to refund any excess collections.



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

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



Sec. 402.7  Notice of proposed determination.

    (a) If HCFA or OIG proposes a penalty and, as applicable, an 
assessment, or proposes to exclude a respondent from participation in 
Medicare in accordance with this part, it sends the respondent written 
notice of its intent by certified mail, return receipt requested. The 
notice includes the following information:
    (1) Reference to the statutory basis or bases for the penalty, 
assessment, exclusion, or any combination, as applicable.
    (2)(i) A description of the claims, requests for payment, or 
incidents with respect to which the penalty, assessment, and exclusion 
are proposed; or
    (ii) If HCFA or OIG is relying upon statistical sampling to project 
the number and types of claims or requests for payment and the dollar 
amount, a description of the claims and requests for payment comprising 
the sample and a brief description of the statistical sampling technique 
HCFA or OIG used.
    (3) The reason why the claims, requests for payment, or incidents 
are subject to a penalty and assessment.
    (4) The amount of the proposed penalty and of any proposed 
assessment.
    (5) Any mitigating or aggravating circumstances that HCFA or OIG 
considered when it determined the amount of the proposed penalty and any 
applicable assessment.
    (6) Information concerning response to the notice, including--
    (i) A specific statement of the respondent's right to a hearing; and
    (ii) A statement that failure to request a hearing within 60 days 
renders the proposed determination final and permits the imposition of 
the proposed penalty and any assessment.
    (iii) A statement that the debt may be collected through an 
administrative offset.
    (7) In the case of a respondent that has an agreement under section 
1866 of the Act, notice that imposition of an exclusion may result in 
termination of the provider's agreement in accordance with section 
1866(b)(2)(C) of the Act.



Sec. 402.9  Failure to request a hearing.

    (a) If the respondent does not request a hearing within 60 days of 
receipt of the notice of proposed determination specified in Sec. 402.7, 
any civil money penalty, assessment, or exclusion becomes final and HCFA 
or OIG may impose the proposed penalty, assessment, or exclusion, or any 
less severe penalty, assessment, or suspension.
    (b) HCFA or OIG notifies the respondent by certified mail, return 
receipt requested, of any penalty, assessment, or exclusion that has 
been imposed and of the means by which the respondent may satisfy the 
judgment.

[[Page 29]]

    (c) The respondent has no right to appeal a penalty, assessment, or 
exclusion for which he or she has not requested a hearing.



Sec. 402.11  Notice to other agencies and other entities.

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



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

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



Sec. 402.15  Collateral estoppel.

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



Sec. 402.17  Settlement.

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



Sec. 402.19  Hearings and appeals.

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



Sec. 402.21  Judicial review.

    After exhausting all available administrative remedies, a respondent 
may seek judicial review of a penalty, assessment, or exclusion that has 
become final. The respondent may seek review only with respect to a 
penalty, assessment, or exclusion with respect to which the respondent 
filed an exception under Sec. 1005.21(c) of this title unless the court 
excuses the failure or neglect to urge the exception in accordance with 
section 1128A(e) of the Act because of extraordinary circumstances.



            Subpart B--Civil Money Penalties and Assessments



Sec. 402.105  Amount of penalty.

    (a) $2,000. Except as provided in paragraphs (b) through (f) of this 
section, HCFA or OIG may impose a penalty of not more than $2,000 for 
each service, bill, or refusal to issue a timely refund that is subject 
to a determination under this part and for each incident involving the 
knowing, willful, and repeated failure of an entity furnishing a service 
to submit a properly completed claim form or to include on the claim 
form accurate information regarding the availability of other health 
insurance benefit plans (Sec. 402.1(c)(21)).
    (b) $1,000. HCFA or OIG may impose a penalty of not more than $1,000 
for the following:

[[Page 30]]

    (1) Per certificate of medical necessity knowingly and willfully 
distributed to physicians on or after December 31, 1994 that--
    (i) Contains information concerning the medical condition of the 
patient; or
    (ii) Fails to include cost information.
    (2) Per individual about whom information is requested, for willful 
or repeated failure of an employer to respond to an intermediary or 
carrier about coverage of an employee or spouse under the employer's 
group health plan (Sec. 402.1(c)(20)).
    (c) $5,000. HCFA or OIG may impose a penalty of not more than $5,000 
for each violation resulting from the following:
    (1) The failure of a Medicare supplemental policy issuer, on a 
replacement policy, to waive any time periods applicable to pre-existing 
conditions, waiting periods, elimination periods, or probationary 
periods that were satisfied under a preceding policy 
(Sec. 402.1(c)(29)); and
    (2) Any issuer of any Medicare supplemental policy denying a policy, 
conditioning the issuance or effectiveness of the policy, or 
discriminating in the pricing of the policy based on health status or 
other criteria as specified in section 1882(s)(2)(A). 
(Sec. 402.1(c)(29)).
    (d) $10,000. (1) HCFA or OIG may impose a penalty of not more than 
$10,000 for each day that reporting entity ownership arrangements is 
late (Sec. 402.1(c)(22)).
    (2) HCFA or OIG may impose a penalty of not more than $10,000 for 
the following violations that occur on or after January 1, 1997:
    (i) Knowingly and willfully, and on a repeated basis, billing for a 
clinical diagnostic laboratory test, other than on an assignment-related 
basis (Sec. 402.1(c)(1)).
    (ii) By any durable medical equipment supplier, knowingly and 
willfully charging for a covered service that is furnished on a rental 
basis after the rental payments may no longer be made (except for 
maintenance and servicing) as provided in section 1834(a)(7)(A) 
(Sec. 402.1(c)(4)).
    (iii) By any durable medical equipment supplier, knowingly and 
willfully, in violation of section 1834(a)(18)(A), failing to make a 
refund to Medicare beneficiaries for a covered service for which payment 
is precluded due to an unsolicited telephone contact from the supplier 
(Sec. 402.1(c)(5)).
    (iv) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge, 
as specified in section 1834(b)(5)(B), for radiologist services 
(Sec. 402.1(c)(6)).
    (v) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge, 
as specified in section 1834(c)(3), for mammography screening 
(Sec. 402.1(c)(7)).
    (vi) By any supplier of prosthetic devices, orthotics, and 
prosthetics, knowingly and willfully charging for a covered prosthetic 
device, orthotic, or prosthetic that is furnished on a rental basis 
after the rental payment may no longer be made (except for maintenance 
and servicing) (Sec. 401.2(c)(8)).
    (vii) By any supplier of durable medical equipment, including a 
supplier of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed other than on an assigned-
related basis if--
    (A) The supplier does not possess a Medicare supplier number;
    (B) The service is denied in advance; or
    (C) The service is determined not to be medically necessary or 
reasonable (Sec. 402.1(c)(10)).
    (viii) Knowingly and willfully billing or collecting for any 
services on other than an assignment-related basis for practitioners 
specified in section 1842(b)(18)(B) (Sec. 402.1(c)(11)).
    (xix) By any physician, knowingly and willfully presenting, or 
causing to be presented, a claim or bill for an assistant at cataract 
surgery performed on or after March 1, 1987 for which payment may not be 
made because of section 1862(a)(15) (Sec. 402.1(c)(12)).
    (x) By any nonparticipating physician who does not accept payment on 
an assignment-related basis, knowingly and willfully failing to refund 
on a timely basis any amounts collected for services that are not 
reasonable or medically necessary or are of poor

[[Page 31]]

quality, in accordance with section 1842(l)(1)(A) (Sec. 402.1(c)(13)).
    (xi) By any nonparticipating physician, who does not accept payment 
for an elective surgical procedure on an assignment-related basis and 
whose charge is at least $500, knowingly and willfully failing to--
    (A) Disclose the information required by section 1842(m)(1) 
concerning charges and coinsurance amounts; and
    (B) Refund on a timely basis any amount collected for the procedure 
in excess of the charges recognized and approved by the Medicare program 
(Sec. 402.1(c)(14)).
    (xii) By any physician, in repeated cases, knowingly and willfully 
billing one or more beneficiaries, for purchased diagnostic tests, any 
amount other than the payment amount specified in section 1842(n)(1)(A) 
or section 1842(n)(1)(B) (Sec. 402.1(c)(15)).
    (xiii) By any nonparticipating physician, supplier, or other person 
that furnishes physicians' services and does not accept payment on an 
assignment-related basis--
    (A) Knowingly and willfully billing or collecting in excess of the 
limiting charge (as defined in section 1843(g)(2)) on a repeated basis; 
or
    (B) Failing to make an adjustment or refund on a timely basis as 
required by section 1848(g)(1)(A)(iii) or (iv) (Sec. 402.1(c)(17)).
    (xiv) Knowingly and willfully billing for State plan approved 
physicians' services on other than an assignment-related basis for a 
Medicare beneficiary who is also eligible for Medicaid 
(Sec. 402.1(c)(18)).
    (xv) By any supplier of durable medical equipment, including a 
supplier of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed on an assignment-related 
basis if--
    (A) The supplier did not possess a Medicare supplier number;
    (B) The service is denied in advance; or
    (C) The service is determined not to be medically necessary or 
reasonable (Sec. 402.1(c)(23)).
    (e) $15,000. HCFA or OIG may impose a penalty of not more than 
$15,000 if the seller of a Medicare supplemental policy is not the 
issuer, for each violation described in paragraphs (f)(2) and (f)(3) of 
this section (Sec. 402.1 (c)(25) and (c)(26)).
    (f) $25,000. HCFA or OIG may impose a penalty of not more than 
$25,000 for each of the following violations:
    (1) Issuance of a Medicare supplemental policy that has not been 
approved by an approved State regulatory program or does not meet 
Federal standards on and after the effective date in section 
1882(p)(1)(C) of the Act (Sec. 402.1(c)(23)).
    (2) Sale or issuance after July 30, 1992, of a Medicare supplemental 
policy that fails to conform with the NAIC or Federal standards 
established under section 1882(p) of the Act (Sec. 402.1(c)(25)).
    (3) Failure to make the core group of basic benefits available for 
sale when selling other Medicare supplemental plans with additional 
benefits (Sec. 402.1(c)(26)).
    (4) Failure to provide, before sale of a Medicare supplemental 
policy, an outline of coverage describing the benefits provided by the 
policy (Sec. 402.1(c)(26)).
    (5) Failure of an issuer of a policy to suspend or reinstate a 
policy, based on the policy holder's request, during entitlement to or 
upon loss of eligibility for medical assistance (Sec. 402.1(c)(27)).
    (6) Failure to provide refunds or credits for Medicare supplemental 
policies as required by section 1882(r)(1)(B) (Sec. 402.1(c)(28)).
    (7) By an issuer of a Medicare supplemental policy--
    (i) Substantial failure to provide medically necessary services to 
enrollees seeking the services through the issuer's network of entities;
    (ii) Imposition of premiums on enrollees in excess of the premiums 
approved by the State;
    (iii) Action to expel an enrollee for reasons other than nonpayment 
of premiums; or
    (iv) Failure to provide each enrollee, at the time of enrollment, 
with the specific information provided in section 1882(t)(1)(E)(i) or 
failure to obtain a written acknowledgment from the enrollee of receipt 
of the information (as required by section 1882(t)(1)(E)(ii)) (section 
1882(t)(2)).

[[Page 32]]



Sec. 402.107  Amount of assessment.

    A person subject to civil money penalties specified in Sec. 402.1(c) 
may be subject, in addition, to an assessment. An assessment is a 
monetary payment in lieu of damages sustained by HHS or a State agency.
    (a) The assessment may not be more than twice the amount claimed for 
each service that was a basis for the civil money penalty, except for 
the violations specified in paragraph (b) of this section that occur 
before January 1, 1997.
    (b) For the violations specified in this paragraph occurring after 
January 1, 1997, the assessment may not be more than three times the 
amount claimed for each service that was the basis for a civil money 
penalty. The violations are the following:
    (1) Knowingly and willfully billing, and on a repeated basis, for a 
clinical diagnostic laboratory test, other than on an assignment-related 
basis (Sec. 402.1(c)(1)).
    (2) By any durable medical equipment supplier, knowingly and 
willfully charging for a covered service that is furnished on a rental 
basis after the rental payments may no longer be made (except for 
maintenance and servicing) as provided in section 1834(a)(7)(A) 
(Sec. 402.1(c)(4)).
    (3) By any durable medical equipment supplier, knowingly and 
willfully failing, in violation of section 1834(a)(18)(A), to make a 
refund to Medicare beneficiaries for a covered service for which payment 
is precluded due to an unsolicited telephone contact from the supplier 
(Sec. 402.1(c)(5)).
    (4) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge, 
as specified in section 1834(b)(5)(B), for radiologist services 
(Sec. 402.1(c)(6)).
    (5) By any nonparticipating physician or supplier, knowingly and 
willfully charging a Medicare beneficiary more than the limiting charge 
as specified in section 1834(c)(3), for mammography screening 
(Sec. 402.1(c)(7)).
    (6) By any supplier of prosthetic devices, orthotics, and 
prosthetics, knowingly and willfully charging for a covered prosthetic 
device, orthotic, or prosthetic that is furnished on a rental basis 
after the rental payment may no longer be made (except for maintenance 
and servicing) (Sec. 401.2(c)(8)).
    (7) By any supplier of durable medical equipment, including a 
supplier of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed other than on an assignment-
related basis if--
    (i) The supplier does not possess a Medicare supplier number;
    (ii) The service is denied in advance; or
    (iii) The service is determined not to be medically necessary or 
reasonable (Sec. 402.1(c)(10)).
    (8) Knowingly and willfully billing or collecting for any services 
on other than an assignment-related basis for practitioners specified in 
section 1842(b)(18)(B) (Sec. 402.1(c)(11)).
    (9) By any physician, knowingly and willfully presenting, or causing 
to be presented, a claim or bill for an assistant at cataract surgery 
performed on or after March 1, 1987 for which payment may not be made 
because of section 1862(a)(15) (Sec. 402.1(c)(12)).
    (10) By any nonparticipating physician who does not accept payment 
on an assignment-related basis, knowingly and willfully failing to 
refund on a timely basis any amounts collected for services that are not 
reasonable or medically necessary or are of poor quality, in accordance 
with section 1842(l)(1)(A) (Sec. 402.1(c)(13)).
    (11) By any nonparticipating physician, who does not accept payment 
for an elective surgical procedure on an assignment-related basis and 
whose charge is at least $500, knowingly and willfully failing to--
    (i) Disclose the information required by section 1842(m)(1) 
concerning charges and coinsurance amounts; and
    (ii) Refund on a timely basis any amount collected for the procedure 
in excess of the charges recognized and approved by the Medicare program 
(Sec. 402.1(c)(14)).
    (12) By any physician, in repeated cases, knowingly and willfully 
billing one or more beneficiaries, for purchased diagnostic tests, any 
amount

[[Page 33]]

other than the payment amount specified in section 1842(n)(1)(A) or 
section 1842(n)(1)(B) (Sec. 402.1(c)(15)).
    (13) By any nonparticipating physician, supplier, or other person 
that furnishes physicians' services and does not accept payment on an 
assignment-related basis--
    (i) Knowingly and willfully billing or collecting in excess of the 
limiting charge (as defined in section 1843(g)(2)) on a repeated basis; 
or
    (ii) Failing to make an adjustment or refund on a timely basis as 
required by section 1848(g)(1)(A) (iii) or (iv) (Sec. 402.1(c)(17)).
    (14) Knowingly and willfully billing for State plan approved 
physicians' services on other than an assignment-related basis for a 
Medicare beneficiary who is also eligible for Medicaid 
(Sec. 402.1(c)(18)).
    (15) By any supplier of durable medical equipment, including 
suppliers of prosthetic devices, prosthetics, orthotics, or supplies, 
knowingly and willfully failing to make refunds in a timely manner to 
Medicare beneficiaries for services billed on an assignment-related 
basis if--
    (i) The supplier did not possess a Medicare supplier number;
    (ii) The service is denied in advance; or
    (iii) The service is determined not to be medically necessary or 
reasonable (Sec. 402.1(c)(23)).



Sec. 402.109  Statistical sampling.

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



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

    (a) Basic factors. In determining the amount of any penalty or 
assessment, HCFA or OIG takes into account the following:
    (1) The nature of the claim, request for payment, or information 
given and the circumstances under which it was presented or given.
    (2) The degree of culpability, history of prior offenses, and 
financial condition of the person submitting the claim or request for 
payment or giving the information.
    (3) The resources available to the person submitting the claim or 
request for payment or giving the information.
    (4) Such other matters as justice may require.
    (b) Criteria to be considered. As guidelines for taking into account 
the factors listed in paragraph (a) of this section, HCFA or OIG 
considers the following circumstances:
    (1) Aggravating circumstances of the incident. An aggravating 
circumstance is any of the following:
    (i) The services or incidents were of several types, occurring over 
a lengthy period of time.
    (ii) There were many of these services or incidents or the nature 
and circumstances indicate a pattern of claims or requests for payment 
for these services or a pattern of incidents.
    (iii) The amount claimed or requested for these services was 
substantial.
    (iv) Before the incident or presentation of any claim or request for 
payment subject to imposition of a civil money penalty, the respondent 
was held liable for criminal, civil, or administrative sanctions in 
connection with a program covered by this part or any other public or 
private program of payment for medical services.
    (v) There is proof that a respondent engaged in wrongful conduct, 
other than the specific conduct upon which liability is based, relating 
to government programs or in connection with the delivery of a health 
care service. (The statute of limitations governing

[[Page 34]]

civil money penalty proceedings does not apply to proof of other 
wrongful conduct as an aggravating circumstance.)
    (2) Mitigating circumstances. The following circumstances are 
mitigating circumstances:
    (i) All the services or incidents subject to a civil money penalty 
were few in number and of the same type, occurred within a short period 
of time, and the total amount claimed or requested for the services was 
less than $1,000.
    (ii) The claim or request for payment for the service was the result 
of an unintentional and unrecognized error in the process of presenting 
claims or requesting payment and the respondent took corrective steps 
promptly after discovering the error.
    (iii) Imposition of the penalty or assessment without reduction 
would jeopardize the ability of the respondent to continue as a health 
care provider.
    (3) Other matters as justice may require. Other circumstances of an 
aggravating or mitigating nature are taken into account if, in the 
interests of justice, they require either a reduction of the penalty or 
assessment or an increase in order to ensure the achievement of the 
purposes of this part.
    (c) Effect of aggravating or mitigating circumstances. In 
determining the amount of the penalty and assessment to be imposed for 
every service or incident subject to a determination under 
Sec. 402.1(c)--
    (1) If there are substantial or several mitigating circumstances, 
the aggregate amount of the penalty and assessment is set at an amount 
sufficiently below the maximum permitted by Secs. 402.105(a) and 402.107 
to reflect that fact.
    (2) If there are substantial or several aggravating circumstances, 
the aggregate amount of the penalty and assessment is set at an amount 
at or sufficiently close to the maximum permitted by Secs. 402.105(a) 
and 402.107 to reflect that fact.
    (d)(1) The standards set forth in this section are binding, except 
to the extent that their application would result in imposition of an 
amount that would exceed limits imposed by the United States 
Constitution.
    (2) The amount imposed is not less than the approximate amount 
required to fully compensate the United States, or any State, for its 
damages and costs, tangible and intangible, including but not limited to 
the costs attributable to the investigation, prosecution, and 
administrative review of the case.
    (3) Nothing in this section limits the authority of HCFA or OIG to 
settle any issue or case as provided by Sec. 402.19 or to compromise any 
penalty and assessment as provided by Sec. 402.115.



Sec. 402.113  When a penalty and assessment are collectible.

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



Sec. 402.115  Collection of penalty or assessment.

    (a) Once a determination by HHS has become final, HCFA is 
responsible for the collection of any penalty or assessment.

[[Page 35]]

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

Subpart C--Exclusions [Reserved]



PART 403--SPECIAL PROGRAMS AND PROJECTS--Table of Contents




Subpart A--[Reserved]

                Subpart B--Medicare Supplemental Policies

Sec.
403.200  Basis and scope.

                           General Provisions

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

                        State Regulatory Programs

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

           Voluntary Certification Program: General Provisions

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

         Voluntary Certification Program: Loss Ratio Provisions

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

      Subpart C--Recognition of State Reimbursement Control Systems

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

Subpart D--[Reserved]

         Subpart E--Beneficiary Counseling and Assistance Grants

403.500  Basis, scope, and definition.
403.501  Eligibility for grants.
403.502  Availability of grants.
403.504  Number and size of grants.
403.508  Limitations.
403.510  Reporting requirements.
403.512  Administration.

Subpart F--[Reserved]

  Subpart G--Religious Nonmedical Health Care Institutions--Benefits, 
                Conditions of Participation, and Payment

403.700  Basis and purpose.
403.702  Definitions and terms.
403.720  Conditions for coverage.
403.724  Valid election requirements.
403.730  Condition of participation: Patient rights.
403.732  Condition of participation: Quality assessment and performance 
          improvement.

[[Page 36]]

403.734  Condition of participation: Food services.
403.736  Condition of participation: Discharge planning.
403.738  Condition of participation: Administration.
403.740  Condition of participation: Staffing.
403.742  Condition of participation: Physical environment.
403.744  Condition of participation: Life safety from fire.
403.746  Condition of participation: Utilization review.
403.750  Estimate of expenditures and adjustments.
403.752  Payment provisions.
403.754  Monitoring expenditure level.
403.756  Sunset provision.

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

Subpart A--[Reserved]



                Subpart B--Medicare Supplemental Policies

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



Sec. 403.200  Basis and scope.

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

                           General Provisions



Sec. 403.201  State regulation of insurance policies.

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



Sec. 403.205  Medicare supplemental policy.

    (a) Except as specified in paragraph (d) of this section, Medicare 
supplemental policy (policy) means a health insurance policy or other 
health benefit plan--
    (1) That a private entity offers to a Medicare beneficiary; and
    (2) That is primarily designed, or is advertised, marketed, or 
otherwise purported to provide payment for expenses incurred for 
services and items that are not reimbursed under the Medicare program 
because of deductibles, coinsurance, or other limitations under 
Medicare.
    (b) Unless otherwise specified in this subpart, the term policy 
includes both policy form and policy.
    (1) Policy form means the form of health insurance contract that is 
approved by and on file with the State agency for the regulation of 
insurance.
    (2) Policy means the contract--
    (i) Issued under the policy form; and
    (ii) Held by the policyholder.
    (c) Medicare supplemental policy includes the following--
    (1) An individual policy.
    (2) A group policy.
    (d) Medicare supplemental policy does not include a Medicare+Choice 
plan or any of the following health insurance policies or health benefit 
plans:
    (1) A policy or plan of one or more employers for employees, former 
employees, or any combination thereof.
    (2) A policy or plan of one or more labor organizations for members, 
former members, or any combination thereof.

[[Page 37]]

    (3) A policy or plan of the trustees of a fund established by one or 
more labor organizations, one or more employers, or any combination, for 
any one or combination of the following--
    (i) Employees.
    (ii) Former employees.
    (iii) Members.
    (iv) Former members.
    (4) A policy or plan of a profession, trade, or occupational 
association, if the association--
    (i) Is composed of individuals all of whom are actively engaged in 
the same profession, trade, or occupation;
    (ii) Has been maintained in good faith for a purpose other than 
obtaining insurance; and
    (iii) Has been in existence for at least two years before the date 
of its initial offering of a Medicare supplemental health insurance 
policy to its members.
    (5) For purposes of the voluntary certification program, a policy 
issued to an employee or to a member of a labor organization as an 
addition to a franchise plan (a plan that enables members of the same 
entity to purchase an individual policy marketed to them under group 
underwriting procedures), if the plan is in existence on July 1, 1982.

[47 FR 32400, July 26, 1982, as amended at 63 FR 35066, June 26, 1998]



Sec. 403.206  General standards for Medicare supplemental policies.

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



Sec. 403.210  NAIC model standards.

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

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



Sec. 403.215  Loss ratio standards.

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

                        State Regulatory Programs



Sec. 403.220  Supplemental Health Insurance Panel.

    (a) Membership. The Supplemental Health Insurance Panel (Panel) 
consists of--
    (1) The Secretary or a designee, who serves as chairperson, and
    (2) Four State Commissioners or Superintendents of Insurance 
appointed

[[Page 38]]

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



Sec. 403.222  State with an approved regulatory program.

    (a) A State has an approved regulatory program if the Panel 
determines that the State has in effect under State law a regulatory 
program that provides for the application of standards, with respect to 
each Medicare supplemental policy issued in that State, that are equal 
to or more stringent than those specified in section 1882 of the Social 
Security Act.
    (b) Policy issued in that State means--
    (1) A group policy, if the holder of the master policy resides in 
that State; and
    (2) An individual policy, if the policy is--
    (i) Issued in that State; or
    (ii) Issued for delivery in that State.
    (c) A policy issued in a State with an approved regulatory program 
is considered to meet the NAIC model standards in Sec. 403.210 and loss 
ratio standards in Sec. 403.215.

           Voluntary Certification Program: General Provisions



Sec. 403.231  Emblem.

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



Sec. 403.232  Requirements and procedures for obtaining certification.

    (a) To be certified by HCFA, a policy must meet--
    (1) The NAIC model standards specified in Sec. 403.210;
    (2) The loss ratio standards specified in Sec. 403.215; and
    (3) Any State requirements applicable to a policy--
    (i) Issued in that State; or
    (ii) Marketed in that State.
    (b) An insuring organization requesting certification of a policy 
must submit the following to HCFA for review--
    (1) A copy of the policy form (including all the documents that 
would constitute the contract of insurance that is proposed to be 
marketed as a certified policy).
    (2) A copy of the application form including all attachments.
    (3) A copy of the uniform certificate issued under a group policy.
    (4) A copy of the outline of coverage, in the form prescribed by the 
NAIC model standards.
    (5) A copy of the Medicare supplement buyers' guide to be provided 
to all applicants if the buyers' guide is not the HCFA/NAIC buyers' 
guide.
    (6) A statement of when and how the outline of coverage and the 
buyers' guide will be delivered and copies of applicable receipt forms.

[[Page 39]]

    (7) A copy of the notice of replacement and statement as to when and 
how that notice will be delivered.
    (8) A list of States in which the policy is authorized for sale. If 
the policy was approved under a deemer provision in any State, the 
conditions involved must be specified.
    (9) A copy of the loss ratio calculations, as specified in 
Sec. 403.250.
    (10) Loss ratio supporting data, as specified in Sec. 403.256.
    (11) A statement of actuarial opinion, as specified in Sec. 403.258.
    (12) A statement that the insuring organization will notify the 
policyholders in writing, within the period of time specified in 
Sec. 403.245(c), if the policy is identified as a certified policy at 
the time of sale and later loses certification.
    (13) A signed statement in which the president of the insuring 
organization, or a designee, attests that--
    (i) The policy meets the requirements specified in paragraph (a) of 
this section; and
    (ii) The information submitted to HCFA for review is accurate and 
complete and does not misrepresent any material fact.



Sec. 403.235  Review and certification of policies.

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



Sec. 403.239  Submittal of material to retain certification.

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



Sec. 403.245  Loss of certification.

    (a) A policy loses certification if--
    (1) The insuring organization withdraws the policy from the 
voluntary certification program; or
    (2) HCFA determines that--
    (i) The policy fails to meet the requirements specified in 
Sec. 403.232(a); or
    (ii) The insuring organization has failed to meet the requirements 
for submittal of material specified in Sec. 403.239.
    (b) If a policy loses its certification, HCFA will inform all State 
Commissioners and Superintendents of Insurance of that fact.
    (c) If a policy that displays the emblem, or that has been marketed 
as a certified policy without the emblem, loses certification, the 
insuring organization must notify each holder of the

[[Page 40]]

policy, or of a certificate issued under the policy, of that fact. The 
notice must be in writing and sent by the earlier of--
    (1) The date of the first regular premium notice after the date the 
policy loses its certification; or
    (2) 60 days after the date the policy loses its certification.



Sec. 403.248  Administrative review of HCFA determinations.

    (a) This section provides for administrative review if HCFA 
determines--
    (1) Not to certify a policy; or
    (2) That a policy no longer meets the standards for certification.
    (b) If HCFA makes a determination specified in paragraph (a) of this 
section, it will send a notice to the insuring organization containing 
the following information:
    (1) That HCFA has made such a determination.
    (2) The reasons for the determination.
    (3) That the insuring organization has 30 days from the date of the 
notice to--
    (i) Request, in writing, an administrative review of the HCFA 
determination; and
    (ii) Submit additional information to HCFA for review.
    (4) That, if the insuring organization requests an administrative 
review, HCFA will conduct the review, as provided for in paragraph (c) 
of this section.
    (5) That, in a case involving loss of certification, the HCFA 
determination will go into effect 30 days from the date of the notice, 
unless the insuring organization requests an administrative review. If 
the insuring organization requests an administrative review, the policy 
retains its certification until HCFA makes a final determination.
    (c) If the insuring organization requests an administrative review, 
HCFA will conduct the review as follows--
    (1) A HCFA official, not involved in the initial HCFA determination, 
will initiate and complete an administrative review within 90 days of 
the date of the notice provided for in paragraph (b) of this section.
    (2) The official will consider--
    (i) The original material submitted to HCFA for review, as specified 
in Sec. 403.232(b) or Sec. 403.239(a); and
    (ii) Any additional information, that the insuring organization 
submits to HCFA.
    (3) Within 15 days after the administrative review is completed, 
HCFA will inform the insuring organization in writing of the final 
decision, with an explanation of the final decision.
    (4) If the final decision is that a policy lose its certification, 
the loss of certification will go into effect 15 days after the date of 
HCFA's notice informing the insuring organization of the final decision.

         Voluntary Certification Program: Loss Ratio Provisions



Sec. 403.250  Loss ratio calculations: General provisions.

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



Sec. 403.251  Loss ratio date and time frame provisions.

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

[[Page 41]]



Sec. 403.253  Calculation of benefits.

    (a) General provisions. (1) Except as provided for in paragraph 
(a)(2) of this section, calculate the amount of ``benefits'' by--
    (i) Adding the present values on the initial calculation date of--
    (A) Expected incurred benefits in the loss ratio calculation period, 
to--
    (B) The total policy reserve at the last day of the loss ratio 
calculation period: and
    (ii) Subtracting the total policy reserve on the initial calculation 
date from the sum of these values.
    (2) To calculate the amount of ``benefits'' in the case of community 
or pool rated individual or group policies rerated on an annual basis, 
calculate the expected incurred benefits in the loss ratio calculation 
period.
    (b) Calculation of total policy reserve--(1) Option for calculation. 
The insuring organization must calculate ``total policy reserve'' 
according to the provisions of paragraph (b) (2) or (3) of this section.
    (2) Total policy reserve: Federal provisions. (i) ``Total policy 
reserve'' means the sum of--
    (A) Additional reserve; and
    (B) The reserve for future contingent benefits.
    (ii) Additional reserve means the amount calculated on a net level 
reserve basis, using appropriate values to account for lapse, mortality, 
morbidity, and interest, that on the valuation date represents--
    (A) The present value of expected incurred benefits over the loss 
ratio calculation period; less--
    (B) The present value of expected net premiums over the loss ratio 
calculation period.
    (iii) Net premium means the level portion of the gross premium used 
in calculating the additional reserve. On the day the policy is issued, 
the present value of the series of those portions equals the present 
value of the expected incurred claims over the period that the gross 
premiums are computed to provide coverage.
    (iv) Reserve for future contingent benefits means the amounts, not 
elsewhere included, that provide for the extension of benefits after 
insurance coverage terminates. These benefits--
    (A) Are predicated on a health condition existing on the date 
coverage ends;
    (B) Accrue after the date coverage ends; and
    (C) Are payable after the valuation date.
    (3) Total policy reserve: State provisions. ``Total policy reserve'' 
means the total policy reserve calculated according to appropriate State 
law or regulation.



Sec. 403.254  Calculation of premiums.

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

[[Page 42]]



Sec. 403.256  Loss ratio supporting data.

    (a) For purposes of requesting HCFA certification under 
Sec. 403.232, the insuring organization must submit the following loss 
ratio data to HCFA for review--
    (1) A statement of why the policy is to be considered, for purposes 
of the loss ratio standards, an individual or a group policy.
    (2) The earliest age at which policyholders can purchase the policy.
    (3) The general marketing method and the underwriting criteria used 
for the selection of applicants to whom coverage is offered.
    (4) What policies are to be included under the one policy form, by 
the dates the policies are issued.
    (5) The loss ratio calculation period.
    (6) The scale of premiums for the loss ratio calculation period.
    (7) The expected level of earned premiums in the loss ratio 
calculation period.
    (8) The expected level of incurred claims in the loss ratio 
calculation period.
    (9) A description of how the following assumptions were used in 
calculating the loss ratio.
    (i) Morbidity.
    (ii) Mortality.
    (iii) Lapse.
    (iv) Assumed increases in the Medicare deductible.
    (v) Impact of inflation on reimbursement per service.
    (vi) Interest.
    (vii) Expected distribution, by age and sex, of persons who will 
purchase the policy in the coming year.
    (viii) Expected impact on morbidity by policy duration of--
    (A) The process used to select insureds from among those that apply 
for a policy; and
    (B) Pre-existing condition clauses in the policy.
    (b) For purposes of requesting continued HCFA certification under 
Sec. 403.239(a), the insuring organization must submit the following to 
HCFA--
    (1) A description of all changes in the loss ratio data, specified 
in paragraph (a) of this section, that occurred since HCFA last reviewed 
the policy.
    (2) The past loss ratio experience for the policy, including the 
experience of all riders and endorsements issued under the policy. The 
loss ratio experience data must include earned premiums, incurred 
claims, and total policy reserves that the insuring organization 
calculates--
    (i) For all years of issue combined; and
    (ii) Separately for each calendar year since HCFA first certified 
the policy.



Sec. 403.258  Statement of actuarial opinion.

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



      Subpart C--Recognition of State Reimbursement Control Systems

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



Sec. 403.300  Basis and purpose.

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

[[Page 43]]

    (3) The conditions that apply if the system is approved.



Sec. 403.302  Definitions.

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



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

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

[[Page 44]]

including Federal and State programs. Under the requirement, the 
following conditions must be met:
    (i) Both the Medicare and Medicaid programs must participate under 
the system.
    (ii) The State must assure equitable and uniform treatment under the 
system of third-party payors of inpatient hospital services in terms of 
opportunity. Equitable opportunity must include, but need not be limited 
to, participation in the system and availability of discounts. Criteria 
under which discounts are made available must be equitably and uniformly 
applied to all payors, except for discounts negotiated by HMOs and CMPs. 
Discounts available to HMOs and CMPs as result of their statutory right 
to negotiate payment rates independently of a State system, as described 
in paragraph (b)(7) of this section, need not be available to other 
payors.
    (iii) The State must assure that all third-party payors that 
participate under the system share in the system's risks and benefits.
    (3) The amount of Medicare payments made under the system over 36-
month periods may not exceed the amount of Medicare payment that would 
otherwise have been made under the Medicare principles of reimbursement 
for Medicare items and services had the State system not been in effect. 
States must submit the assurance and supporting data as required by 
Sec. 403.320 to document that the payment limit is not exceeded. States 
that have an existing Medicare demonstration project in effect on April 
20, 1983, and that have requested approval of a State system under 
section 1886(c)(4) of the Act, may elect to have the effectiveness of 
the State system under this paragraph judged on the basis of the State 
system's rate of increase or inflation in Medicare inpatient hospital 
payments as compared to the national rate of increase or inflation for 
such payments during the three cost reporting periods of the hospitals 
in the State beginning on or after October 1, 1983.
    (d) Additional cost-effectiveness assurance. If the assurances and 
supporting data required under paragraph (c)(3) of this section are 
insufficient to provide assurance satisfactory to HCFA regarding the 
cost-effectiveness of a State system, the State may additionally submit 
one of the following assurances in order to meet the cost-effectiveness 
test:
    (1) State responsibility for excess payments. The State must agree 
that each month Medicare intermediaries will disburse to the State's 
hospital Federal funds that in the aggregate equal no more than would 
have been disbursed in the absence of the State system. Any additional 
funds necessary to pay hospitals for Medicare services required by the 
State system will be paid to the intermediaries by the State. These 
additional amounts will be refunded to the State by the intermediaries 
to the extent that, in subsequent months, the State system requires a 
smaller aggregate payment for Medicare services than would have been 
paid in the absence of the State system.
    (2) Limitations on payments. (i) The State must agree that if its 
projections exceed what Medicare would pay in any particular period, the 
State and HCFA will establish and agreed upon payment schedule that will 
limit payments under the State system based on a predetermined 
percentage relationship between projected State payments and what 
payments would have been under Medicare.
    (ii) If deviation from the predetermined relationship described in 
paragraph (d)(2)(i) of this section occurs, the State must further agree 
that--
    (A) Medicare payments would be capped automatically at payment 
levels based on the rates used for the Medicare prospective payment 
system and the State would be required to pay the difference to 
individual hospitals in its system; or
    (B) The State may provide by legislation or legally binding 
regulations that any reduced payments to hospitals under the system that 
result from this cost-effectiveness assurance will constitute full and 
final payment for hospital services furnished to Medicare beneficiaries 
for the period covered by these reduced payments.

[[Page 45]]



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

    (a) General policy--(1) Mandatory approval. HFCA will approve an 
application for Medicare reimbursement under a State system if the 
system meets all of the requirements of Sec. 403.304 and of paragraph 
(b) of this section.
    (2) Exception. HCFA may approve an application if the State system 
meets all of the requirements of Sec. 403.304 but only some of the 
requirements of paragraph (b) of this section.
    (b) Additional requirements--(1) Operation of system. The system 
must--
    (i) Be operated directly by the State or by entity designated under 
State law;
    (ii) Provide for payments to hospitals using a methodology under 
which--
    (A) Prospectively determined payment rates are established; and
    (B) Exceptions, adjustments, and methods for changes in methodology 
are set forth;
    (iii) Provide that a change by the State in the system that has the 
effect of materially changing payments to hospitals can take effect only 
upon 60 days notice to HCFA and to the hospitals likely to be materially 
affected by the change and upon HCFA's approval of the change.
    (2) Satisfactory assurances--(i) Admissions practice. The State must 
assure that the operation of the system will not result in any change in 
hospital admission practices that result in--
    (A) A significant reduction in the proportion of patients receiving 
hospital services covered under the system who have no third-party 
coverage and who are unable to pay for hospital services;
    (B) A significant reduction in the proportion of individuals 
admitted to hospitals for inpatient hospital services for which payment 
is less, or is likely to be less, than the anticipated charges for or 
cost of the services;
    (C) A refusal to admit patients who would be expected to require 
unusually costly or prolonged treatment for reasons other than those 
related to the appropriateness of the care available at the hospital; or
    (D) A refusal to provide emergency services to any person who is in 
need of emergency services, if the hospital provides the services.
    (ii) Consultation with local government officials. The State must 
provide documentation that it has consulted with local government 
officials concerning the impact of the system on publicly owned or 
operated hospitals.



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

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



Sec. 403.310  Reduction in payments.

    (a) General rule. If HCFA determines that the satisfactory 
assurances required of a State under Sec. 403.304(c) and, if applicable, 
Sec. 403.304(d) have not been met, or will not be met, with respect to 
any 36-month period, HCFA will reduce Medicare payments to individual 
hospitals being reimbursed under the State's system or, if applicable, 
under the Medicare payment system, in an amount equal to the amount by 
which the Medicare payments under the system exceed the amount of 
Medicare payments to such hospitals that otherwise would have been made 
not using the State system. The amount of the recoupment will include, 
when appropriate, interest charges computed in accordance with 
Sec. 405.378 of this chapter.
    (b) Recoupment procedures. The amount of the overpayment will be 
recouped on a proportionate basis from each of those hospitals that 
received payments under the State system that exceeded the payments they 
would have received under the Medicare payment system. Each hospital's 
share of the aggregate excess payment will be determined on the basis of 
a comparison of the hospital's proportionate share of the aggregate 
payment received under the State system that is

[[Page 46]]

in excess of what the aggregate payment would have been under the 
Medicare payment system. Recoupments may be accomplished by a hospital's 
direct payment to the Medicare program or by offsets to future payments 
made to the hospital.
    (c) Alternative recoupment procedures. As an alternative to the 
recoupment procedures described in paragraph (b) of this section and 
subject to HCFA's acceptance, the State may provide, by legislation or 
legally binding regulations, procedures for the recoupment of the amount 
of payments that exceed the amount of payments that otherwise would have 
been paid by Medicare if the State system had not been in effect.
    (d) Rule for existing Medicare demonstration projects. In cases of 
existing Medicare demonstration projects where the expenditure test is 
to be applied by a rate of increase factor, the amount of the excess 
payment will be determined, for the three hospital cost reporting 
periods beginning before October 1, 1986, by a comparison of the State 
system's rate of increase to the national rate of increase. Recoupment 
of excessive payments will be assessed and recouped as described in this 
section.

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



Sec. 403.312  Submittal of application.

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



Sec. 403.314  Evaluation of State systems.

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



Sec. 403.316  Reconsideration of certain denied applications.

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



Sec. 403.318  Approval of State systems.

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

[[Page 47]]

    (b) Effective date. An approved State system may not be effective 
earlier than the date of the approval agreement, which may not be 
retroactive.



Sec. 403.320  HCFA review and monitoring of State systems.

    (a) General rule. The State must submit an assurance and detailed 
and quantitative studies of provider cost and financial data and 
projections to support the effectiveness of its system, as required by 
paragraphs (b) and (c) of this section.
    (b) Required information. (1) Under Sec. 403.304(c)(3) an assurance 
is required that the system will not result in greater payments over a 
36-month period than would have otherwise been made under Medicare not 
using such system. If a State that has an existing demonstration project 
in effect on April 20, 1983 elects under Sec. 403.304(c)(3) to have the 
effectiveness of its system judged on the basis of a rate of increase 
factor, the State must submit an assurance that its rate of increase or 
inflation in inpatient hospital payments does not exceed, for that 
portion of the 36-month period that is subject to this test, the 
national rate of increase or inflation in Medicare inpatient hospital 
payments. The election of the rate of increase test applies only to the 
three cost reporting periods beginning on or after October 1, 1983. At 
the end of these cost reporting periods, the State must assure, 
beginning with the first month after the expiration of the third cost 
reporting period beginning after October 1, 1983, that payments under 
its system will not exceed over the remainder of the 36-month period 
what Medicare payments would have been.
    (2) Estimates and data are required to support the State's 
assurance, required under Sec. 403.304(c)(3), that expenditures under 
the State system will not exceed what Medicare would have paid over a 
36-month period. The estimates and projections of what Medicare would 
have otherwise paid must take into account all the Medicare 
reimbursement principles in effect at the time and, for any period in 
which payments either exceed or are less than Medicare levels, the 
values of interest the Medicare Trust Fund earned, or would have earned, 
on these amounts. Upon application for approval, the State must submit 
projections for each hospital for the first 12-month period covered by 
the assurance, in both the aggregate and on a per discharge basis, of 
Medicare inpatient expenditures under Medicare principles of 
reimbursement and parallel projections of Medicare inpatient 
expenditures under the State's system and the resulting cost or savings 
to Medicare. The State must also submit separate statewide projections 
for each year of the 36-month period, in both the aggregate and on a 
weighted average discharge basis, of inpatient expenditures under the 
State system and under the Medicare principles of reimbursement.
    (3) The projection submitted under paragraph (b)(2) of this section 
must include a detailed description of the methodology and assumptions 
used to derive the expenditure amounts under both systems. In instances 
where the assumptions are different under the projections cited in 
paragraph (b)(2) of this section, the State must provide a detailed 
explanation of the reasons for the differences. At a minimum, the 
following separate data and assumptions are to be included in the 
projections for the Medicare principles and for the State's system.
    (i) The State system base year and the Medicare allowable and 
reimbursable cost of each hospital that the State used to develop the 
projections, including the amount of estimated pass through costs.
    (ii) The categories of costs that are included in the State system 
and are reimbursed differently under the State system than under the 
Medicare system.
    (iii) The number of Medicare and total base year discharges and 
admissions for each hospital.
    (iv) The rate of change factor (and the method of application of 
this factor) used to project the base year costs over the 36-month 
period to which the assurance would apply.
    (v) Any allowance for anticipated growth in the amount of services 
from the base year (if applicable, the allowance must be presented in 
separate estimates for population increases or for

[[Page 48]]

increases in rates of admissions or both).
    (vi) Any adjustment in which the State is permitted by HCFA to take 
into account previous reductions in the Medicare payment amounts that 
were the result of the effectiveness of the State's system even though 
Medicare was not a part of that system.
    (vii) Appropriate recognition and projection of the time value of 
trust fund expenditures for the period the State system expenditures 
were either less than or exceeded the Medicare system payments.
    (viii) States applying under a rate of increase effectiveness test 
under Sec. 403.304(c)(3) must also submit data projecting the parallel 
rates of increase during the requisite period.
    (4) The projections must include both the aggregate payments and the 
payments per discharge for the individual hospitals and for the State as 
a whole.
    (5) On a case-by-case basis. HCFA may require additional data and 
documentation as needed to complete its review and monitoring.
    (6) For existing Medicare demonstration projects in effect on April 
20, 1983, the assurance and data as required by paragraphs (a) and (b) 
of this section, if appropriate, may be based on aggregate payments or 
payments per inpatient admission or discharge. HCFA will judge the 
effectiveness of these systems on the basis of the rate of increase or 
inflation in Medicare inpatient hospital payments compared to the 
national rate of increase or inflation for such payments during the 
State's hospitals' three cost reporting periods beginning on or after 
October 1, 1983. The data submitted by the State for the period subject 
to the rate of increase test must include the rate of increase 
projection for that particular period of time. For the subsequent period 
of time, the State must assure that payments under its system will not 
exceed what Medicare payments would have been, as described in 
Sec. 403.304(c)(3).
    (7) If the amount of Medicare payments under the State system 
exceeds what would have been paid under the Medicare reimbursement 
principles in any given year, the State must also submit quantitative 
evidence that the system will result in expenditures that do not exceed 
what Medicare expenditures would have been over the 36 month period 
beginning with the first month that the State system is operating. For a 
State that has an existing demonstration project in effect on April 20, 
1983, and that elects under Sec. 403.304(c)(3) to have a rate of 
increase test apply, if the State's rate of increase or inflation 
exceeds the national rate of increase or inflation in a given year, the 
State must submit quantitative evidence that, over 36 months, its 
payments will not exceed the national rate of increase or inflation. 
Furthermore, if payments under the State's system must be compared to 
actual Medicare expenditures, at the end of the third cost reporting 
period, as described in paragraph (b)(1) of this section, and payments 
under the State's system exceed what Medicare would have paid in a given 
year, the State must submit quantitative evidence that, over 36 months, 
payments under its system will not exceed what Medicare would have paid.
    (c) Review of assurances regarding expenditures. HCFA will review 
the State's assurances and data submitted under this section, as a 
prerequisite to the approval of the State's system. HCFA will compare 
the State's projections of payment amounts to HCFA data in order to 
determine if the State's assurance is reasonable and fully supportable. 
If the HCFA data indicate that the State's system would result in 
payment amounts that would be more then that which would have been paid 
under the Medicare principles, the State's assurances would not be 
acceptable. For States applying in accordance with Sec. 403.308, if HCFA 
data indicate that the State's system would result in a rate of increase 
or inflation that would be more than the national rate of increase or 
inflation, the State's assurances would not be acceptable.
    (d) Medicaid upper limit. In accordance with Sec. 447.253 of this 
chapter, the State system may not result in aggregate payments for 
Medicaid inpatient hospital services that would exceed the amount that 
would have otherwise have been paid under the Medicare

[[Page 49]]

principles as applied through the State system.
    (e) Monitoring of Medicare expenditures. HCFA will monitor on a 
quarterly basis expenditures under the State's system as compared to 
what Medicare expenditures would have been if the system had not been in 
effect. If HCFA determines at any time that the payments made under the 
State's system exceed the States' projections, as established by the 
satisfactory assurances required under Sec. 403.304(c) and, if 
appropriate, the predetermined percentage relationship of the payments 
as required under Sec. 403.304(d). HCFA will--
    (1) Conclude that payments under the State system over a 36-month 
period will exceed what Medicare would have paid:
    (2) Terminate the waiver; and
    (3) Recoup overpayments to the affected hospitals in accordance with 
the procedures described in Sec. 403.310.



Sec. 403.321  State systems for hospital outpatient services.

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



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

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

[[Page 50]]

Subpart D--[Reserved]



         Subpart E--Beneficiary Counseling and Assistance Grants

    Source: 59 FR 51128, Oct. 7, 1994, unless otherwise noted.



Sec. 403.500  Basis, scope, and definition.

    (a) Basis. This subpart implements, in part, the provisions of 
section 4360 of Public Law 101-508 by establishing a minimum level of 
funding for grants made to States for the purpose of providing 
information, counseling, and assistance relating to obtaining adequate 
and appropriate health insurance coverage to individuals eligible to 
receive benefits under the Medicare program.
    (b) Scope of subpart. This subpart sets forth the following:
    (1) Conditions of eligibility for the grant.
    (2) Minimum levels of funding for those States qualifying for the 
grants.
    (3) Reporting requirements.
    (c) Definition. For purposes of this subpart, the term ``State'' 
includes (except where otherwise indicated by the context) the 50 
States, the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, Guam, and American Samoa.



Sec. 403.501  Eligibility for grants.

    To be eligible for a grant under this subpart, the State must have 
an approved Medicare supplemental regulatory program under section 1882 
of the Act and submit a timely application to HCFA that meets the 
requirements of--
    (a) Section 4360 of Public Law 101-508 (42 USC 1395b-4);
    (b) This subpart; and
    (c) The applicable solicitation for grant applications issued by 
HCFA.



Sec. 403.502  Availability of grants.

    HCFA awards grants to States subject to availability of funds, and 
if applicable, subject to the satisfactory progress in the State's 
project during the preceding grant period. The criteria by which 
progress is evaluated and the performance standards for determining 
whether satisfactory progress has been made are specified in the terms 
and conditions included in the notice of grant award sent to each State. 
HCFA advises each State as to when to make application, what to include 
in the application, and provides information as to the timing of the 
grant award and the duration of the grant award. HCFA also provides an 
estimate of the amount of funds that may be available to the State.

[65 FR 34985, June 1, 2000]



Sec. 403.504  Number and size of grants.

    (a) General. For available grant funds, up to and including 
$10,000,000, grants will be made to States according to the terms and 
formula in paragraphs (b) and (c) of this section. For any available 
grant funds in excess of $10,000,000, distribution of grants will be at 
the discretion of HCFA, and will be made according to criteria that HCFA 
will communicate to the States via grant solicitation. HCFA will provide 
information to each State as to what must be included in the application 
for grant funds. HCFA awards the following type of grants:
    (1) New program grants.
    (2) Existing program enhancement grants.
    (b) Grant Award. Subject to the availability of funds, each eligible 
State that submits an acceptable application receives a grant that 
includes a fixed amount (minimum funding level) and a variable amount.
    (1) A fixed portion is awarded to States in the following amounts:
    (i) Each of the 50 States, $75,000.
    (ii) The District of Columbia, $75,000.
    (iii) Puerto Rico, $75,000.
    (iv) American Samoa, $25,000.
    (v) Guam, $25,000.
    (vi) The Virgin Islands, $25,000.
    (2) A variable portion, which is based on the number and location of 
Medicare beneficiaries residing in the State is awarded to each State. 
The variable amount a particular State receives is determined as set 
forth in paragraph (c) of this section.
    (c) Calculation of variable portion of the grant. (1) HCFA bases the 
variable portion of the grant on--
    (i) The amount of available funds, and
    (ii) A comparison of each State with the average of all of the 
States (except

[[Page 51]]

the State being compared) with respect to three factors that relate to 
the size of the State's Medicare population and where that population 
resides.
    (2) The factors HCFA uses to compare States' Medicare populations 
comprise separate components of the variable amount. These factors, and 
the extent to which they each contribute to the variable amount, are as 
follows:
    (i) Approximately 75 percent of the variable amount is based on the 
number of Medicare beneficiaries living in the State as a percentage of 
all Medicare beneficiaries nationwide.
    (ii) Approximately 10 percent of the variable amount is based on the 
percentage of the State's total population who are Medicare 
beneficiaries.
    (iii) Approximately 15 percent of the variable amount is based on 
the percentage of the State's Medicare beneficiaries that reside in 
rural areas (``rural areas'' are defined as all areas not included 
within a Metropolitan Statistical Area).
    (3) Based on the foregoing four factors (that is, the amount of 
available funds and the three comparative factors), HCFA determines a 
variable rate for each participating State for each grant period.
    (d) Submission of revised budget. A State that receives an amount of 
grant funds under this subpart that differs from the amount requested in 
the budget submitted with its application must submit a revised budget 
to HCFA, along with its acceptance of the grant award, that reflects the 
amount awarded.

[59 FR 51128, Oct. 7, 1994, as amended at 65 FR 34986, June 1, 2000]



Sec. 403.508  Limitations.

    (a) Use of grants. Except as specified in paragraph (b) of this 
section, and in the terms and conditions in the notice of grant award, a 
State that receives a grant under this subpart may use the grant for any 
reasonable expenses for planning, developing, implementing, and/or 
operating the program for which the grant is made as described in the 
solicitation for application for the grant.
    (b) Maintenance of effort. A State that receives a grant to 
supplement an existing program (that is, an existing program enhancement 
grant)--
    (1) Must not use the grant to supplant funds for activities that 
were conducted immediately preceding the date of the initial award of a 
grant made under this subpart and funded through other sources 
(including in-kind contributions).
    (2) Must maintain the activities of the program at least at the 
level that those activities were conducted immediately preceding the 
initial award of a grant made under this subpart.

[59 FR 51128, Oct. 7, 1994, as amended at 65 FR 34986, June 1, 2000]



Sec. 403.510  Reporting requirements.

    A State that receives a grant under this subpart must submit at 
least one annual report to HCFA and any additional reports as HCFA may 
prescribe in the notice of grant award. HCFA advises the State of the 
requirements concerning the frequency, timing, and contents of reports 
in the notice of grant award that it sends to the State.



Sec. 403.512  Administration.

    (a) General. Administration of grants will be in accordance with the 
provisions of this subpart, 45 CFR part 92 (``Uniform Administrative 
Requirements for Grants and Cooperative Agreements to State and Local 
Governments''), 45 CFR 74.4, the terms of the solicitation, and the 
terms of the notice of grant award. Except for the minimum funding 
levels established by Sec. 403.504(b)(1), in the event of conflict 
between a provision of the notice of grant award, any provision of the 
solicitation, or of any regulation enumerated in 45 CFR 74.4 or in part 
92, the terms of the notice of grant award control.
    (b) Notice. HCFA provides notice to each applicant regarding HCFA's 
decision on an application for grant funding under Sec. 403.504.
    (c) Appeal. Any applicant for a grant under this subpart has the 
right to appeal HCFA's determination regarding its application. Appeal 
procedures are governed by the regulations at 45 CFR part 16 (Procedures 
of the Departmental Grant Appeals Board).

[[Page 52]]

Subpart F [Reserved]



  Subpart G--Religious Nonmedical Health Care Institutions--Benefits, 
                Conditions of Participation, and Payment

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



Sec. 403.700  Basis and purpose.

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



Sec. 403.702  Definitions and terms.

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



Sec. 403.720  Conditions for coverage.

    Medicare covers services furnished in an RNHCI if the following 
conditions are met:
    (a) The provider meets the definition of an RNHCI as defined in 
section 1861(ss)(1) of the Act. That is, it is an institution that:
    (1) Is described in section 501(c)(3) of the Internal Revenue Code 
of 1986 and is exempt from taxes under section 501(a).
    (2) Is lawfully operated under all applicable Federal, State, and 
local laws and regulations.
    (3) Furnishes only nonmedical nursing items and services to 
beneficiaries who choose to rely solely upon a religious method of 
healing and for whom the acceptance of medical services would be 
inconsistent with their religious beliefs.
    (4) Furnishes nonmedical items and services exclusively through 
nonmedical nursing personnel who are experienced in caring for the 
physical needs of nonmedical patients.
    (5) Furnishes nonmedical items and services to inpatients on a 24-
hour basis.
    (6) Does not furnish, on the basis of religious beliefs, through its 
personnel or otherwise medical items and services (including any medical 
screening, examination, diagnosis, prognosis, treatment, or the 
administration of drugs) for its patients.
    (7) Is not owned by, is not under common ownership with, or does not 
have an ownership interest of 5 percent or more in, a provider of 
medical treatment or services and is not affiliated with a provider of 
medical treatment or services or with an individual who has an ownership 
interest of 5 percent

[[Page 53]]

or more in, a provider of medical treatment or services. (Permissible 
affiliations are described at Sec. 403.738(c).)
    (8) Has in effect a utilization review plan that sets forth the 
following:
    (i) Provides for review of the admissions to the institution, the 
duration of stays, and the need for continuous extended duration of 
stays in the institution, and the items and services furnished by the 
institution.
    (ii) Requires that reviews be made by an appropriate committee of 
the institution that included the individuals responsible for overall 
administration and for supervision of nursing personnel at the 
institution.
    (iii) Provides that records be maintained of the meetings, 
decisions, and actions of the review committee.
    (iv) Meets other requirements as the Secretary finds necessary to 
establish an effective utilization review plan.
    (9) Provides information HCFA may require to implement section 1821 
of the Act, including information relating to quality of care and 
coverage decisions.
    (10) Meets other requirements HCFA finds necessary in the interest 
of the health and safety of the patients who receive services in the 
institution. These requirements are the conditions of participation in 
this subpart.
    (b) The provider meets the conditions of participation cited in 
Secs. 403.730 through 403.746. (A provider may be deemed to meet 
conditions of participation in accordance with part 488 of this 
chapter.)
    (c) The provider has a valid provider agreement as a hospital with 
HCFA in accordance with part 489 of this chapter and for payment 
purposes is classified as an extended care hospital.
    (d) The beneficiary has a condition that would make him or her 
eligible to receive services covered under Medicare Part A as an 
inpatient in a hospital or SNF.
    (e) The beneficiary has a valid election as described in 
Sec. 403.724 in effect for Medicare covered services furnished in an 
RNHCI.



Sec. 403.724  Valid election requirements.

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

[[Page 54]]

    (i) The third election is not effective until 1 year after the date 
of the most recent revocation.
    (ii) Any succeeding elections are not effective until 5 years after 
the date of the most recent revocation.
    (2) HCFA will not accept as the basis for payment of any claim any 
elections executed on or after January 1 of the calendar year in which 
the sunset provision described in Sec. 403.756 becomes effective.



Sec. 403.730  Condition of participation: Patient rights.

    An RNHCI must protect and promote each patient's rights.
    (a) Standard: Notice of rights. The RNHCI must do the following:
    (1) Inform each patient of his or her rights in advance of 
furnishing patient care.
    (2) Have a process for prompt resolution of grievances, including a 
specific person within the facility whom a patient may contact to file a 
grievance. In addition, the facility must provide patients with 
information about the facility's process as well as with contact 
information for appropriate State and Federal resources.
    (b) Standard: Exercise of rights. The patient has the right to:
    (1) Be informed of his or her rights and to participate in the 
development and implementation of his or her plan of care.
    (2) Make decisions regarding his or her care, including transfer and 
discharge from the RNHCI. (See Sec. 403.736 for discharge and transfer 
requirements.)
    (3) Formulate advance directives and expect staff who furnish care 
in the RNHCI to comply with those directives, in accordance with part 
489, subpart I of this chapter. For purposes of conforming with the 
requirement in Sec. 489.102 that there be documentation in the patient's 
medical records concerning advanced directives, the patient care records 
of a beneficiary in an RNHCI are equivalent to medical records held by 
other providers.
    (c) Standard: Privacy and safety. The patient has the right to the 
following:
    (1) Personal privacy.
    (2) Care in a safe setting.
    (3) Freedom from verbal, psychological, and physical abuse, and 
misappropriation of property.
    (4) Freedom from the use of restraints.
    (5) Freedom from involuntary seclusion.
    (d) Standard: Confidentiality of patient records. For any patient 
care records or election information it maintains on patients, the RNHCI 
must establish procedures to do the following:
    (1) Safeguard the privacy of any information that identifies a 
particular patient. Information from, or copies of, records may be 
released only to authorized individuals, and the RNHCI must ensure that 
unauthorized individuals cannot gain access to or alter patient records. 
Original patient care records must be released only in accordance with 
Federal or State laws, court orders, or subpoenas.
    (2) Maintain the records and information in an accurate and timely 
manner.
    (3) Ensure timely access by patients to the records and other 
information that pertains to that patient.
    (4) Abide by all Federal and State laws regarding confidentiality 
and disclosure for patient care records and election information.



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

    The RNHCI must develop, implement, and maintain a quality assessment 
and performance improvement program.
    (a) Standard: Program scope. (1) The quality assessment and 
performance improvement program must include, but is not limited to, 
measures to evaluate:
    (i) Access to care.
    (ii) Patient satisfaction.
    (iii) Staff performance.
    (iv) Complaints and grievances.
    (v) Discharge planning activities.
    (vi) Safety issues, including physical environment.
    (2) In each of the areas listed in paragraph (a)(1) of this section, 
and any other areas the RNHCI includes, the RNHCI must do the following:
    (i) Define quality assessment and performance improvement measures.

[[Page 55]]

    (ii) Describe and outline quality assessment and performance 
improvement activities appropriate for the services furnished by or in 
the RNHCI.
    (iii) Measure, analyze, and track performance that reflect care and 
RNHCI processes.
    (iv) Inform all patients, in writing, of the scope and 
responsibilities of the quality assessment and performance improvement 
program.
    (3) The RNHCI must set priorities for performance improvement, 
considering the prevalence of and severity of identified problems.
    (4) The RNHCI must act to make performance improvements and must 
track performance to assure that improvements are sustained.
    (b) Standard: Program responsibilities. (1) The governing body, 
administration, and staff are responsible for ensuring that the quality 
assessment and performance improvement program addresses identified 
priorities in the RNHCI and are responsible for the development, 
implementation, maintenance, and performance improvement of assessment 
actions.
    (2) The RNHCI must include all programs, departments, functions, and 
contracted services when developing, implementing, maintaining, and 
evaluating the program of quality assessment and performance 
improvement.



Sec. 403.734  Condition of participation: Food services.

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



Sec. 403.736  Condition of participation: Discharge planning.

    The RNHCI must have in effect a discharge planning process that 
applies to all patients. The process must assure that appropriate post-
institution services are obtained for each patient, as necessary.
    (a) Standard: Discharge planning evaluation. (1) The RNHCI must 
assess the need for a discharge plan for any patient identified as 
likely to suffer adverse consequences if there is no planning and for 
any other patient upon his or her request or at the request of his or 
her legal representative. This discharge planning evaluation must be 
initiated at admission and must include the following:
    (i) An assessment of the possibility of a patient needing post-RNHCI 
services and of the availability of those services.
    (ii) An assessment of the probability of a patient's capacity for 
self-care or of the possibility of the patient being cared for in the 
environment from which he or she entered the RNHCI.
    (2) The staff must complete the assessment on a timely basis so that 
arrangements for post-RNHCI care are made before discharge and so that 
unnecessary delays in discharge are avoided.
    (3) The discharge planning evaluation must be included in the 
patient's rights record for use in establishing an appropriate discharge 
plan and must discuss the results of the evaluation with the patient or 
a legal representative acting on his or her behalf.
    (b) Standard: Discharge plan. (1) If the discharge planning 
evaluation indicates a need for a discharge plan, qualified and 
experienced personnel must develop or supervise the development of the 
plan.

[[Page 56]]

    (2) In the absence of a finding by the RNHCI that the beneficiary 
needs a discharge plan, the beneficiary or his or her legal 
representative may request a discharge plan. In this case, the RNHCI 
must develop a discharge plan for the beneficiary.
    (3) The RNHCI must arrange for the initial implementation of the 
beneficiary's discharge plan.
    (4) If there are factors that may affect continuing care needs or 
the appropriateness of the discharge plan, the RNHCI must reevaluate the 
beneficiary's discharge plan.
    (5) The RNHCI must inform the beneficiary or legal representative 
about the beneficiary's post-RNHCI care requirements.
    (6) The discharge plan must inform the beneficiary or his or her 
legal representative about the freedom to choose among providers of care 
when a variety of providers is available that are willing to respect the 
discharge preferences of the beneficiary or legal representative.
    (c) Standard: Transfer or referral. The RNHCI must transfer or refer 
patients in a timely manner to another facility (including a medical 
facility if requested by the beneficiary, or his or her legal 
representative) in accordance with Sec. 403.730(b)(2).
    (d) Standard: Reassessment. The RNHCI must reassess its discharge 
planning process on an ongoing basis. The reassessment must include a 
review of discharge plans to ensure that they are responsive to 
discharge needs.



Sec. 403.738  Condition of participation: Administration.

    An RNHCI must have written policies regarding its organization, 
services, and administration.
    (a) Standard: Compliance with Federal, State, and local laws. The 
RNHCI must operate in compliance with all applicable Federal, State, and 
local laws, regulations, and codes including, but not limited to, those 
pertaining to the following:
    (1) Protection against discrimination on the basis of race, color, 
national origin, age, or handicap (45 CFR parts 80, 84, and 91).
    (2) Protection of human research subjects (45 CFR part 46).
    (3) Application of all safeguards to protect against the possibility 
of fraud and abuse (42 CFR part 455).
    (b) Standard: Governing body. (1) The RNHCI must have a governing 
body, or a person designated to function as a governing body, that is 
legally responsible for establishing and implementing all policies 
regarding the RNHCI's management and operation.
    (2) The governing body must appoint the administrator responsible 
for the management of the RNHCI.
    (c) Standard: Affiliations and disclosure. (1) An affiliation is 
permissible if it is between one of the following:
    (i) An individual serving as an uncompensated director, trustee, 
officer, or other member of the governing body of an RNHCI and a 
provider of medical treatment or services.
    (ii) An individual who is a director, trustee, officer, employee, or 
staff member of an RNHCI and another individual, with whom he or she has 
a family relationship, who is affiliated with (or has an ownership 
interest in) a provider of medical treatment or services.
    (iii) The RNHCI and an individual or entity furnishing goods or 
services as a vendor to both providers of medical treatment or services 
and RNHCIs.
    (2) The RNHCI complies with the disclosure requirements of 
Secs. 420.206 and 455.104 of this chapter.
    (3) The RNHCI furnishes written notice, including the identity of 
each new individual or company, to HCFA at the time of a change, if a 
change occurs in any of the following:
    (i) Persons with an ownership or control interest, as defined in 
Secs. 420.201 and 455.101 of this chapter.
    (ii) The officers, directors, agents, or managing employees.
    (iii) The religious entity, corporation, association, or other 
company responsible for the management of the RNHCI.
    (iv) The RNHCI's administrator or director of nonmedical nursing 
services.



Sec. 403.740  Condition of participation: Staffing.

    The RNHCI must be staffed with qualified experienced personnel who 
are present in sufficient numbers to meet the needs of the patients.

[[Page 57]]

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



Sec. 403.742  Condition of participation: Physical environment.

    A RNHCI must be designed, constructed, and maintained to ensure the 
safety of the patients, staff, and the public.
    (a) Standard: Buildings. The physical plant and the overall 
environment must be maintained in a manner that ensures the safety and 
well-being of the patients. The RNHCI must have the following:
    (1) Emergency power for emergency lights, for fire detection and 
alarm systems, and for fire extinguishing systems.
    (2) Procedures for the proper storage and disposal of trash.
    (3) Proper ventilation and temperature control and appropriate 
lighting levels to ensure a safe and secure environment.
    (4) A written disaster plan to address loss of power, water, sewage, 
and other emergencies.
    (5) Facilities for emergency gas and water supply.
    (6) An effective pest control program.
    (7) A preventive maintenance program to maintain essential 
mechanical, electrical, and fire protection equipment operating in an 
efficient and safe manner.
    (8) A working call system for patients to summon aid or assistance.
    (b) Standard: Patient rooms. Patient rooms must be designed and 
equipped for adequate care, comfort, and privacy of the patient.
    (1) Patient rooms must meet the following conditions:
    (i) Accommodate no more than four patients.
    (ii) Measure at least 80 square feet per patient in multiple patient 
rooms and at least 100 square feet in single patient rooms.
    (iii) Have direct access to an exit corridor.
    (iv) Be designed or equipped to assure full visual privacy for each 
patient.
    (v) Have at least one window to the outside.
    (vi) Have a floor at or above grade level.
    (2) The RNHCI must furnish each patient with the following:
    (i) A separate bed of proper size and height for the convenience of 
the patient.
    (ii) A clean, comfortable mattress.
    (iii) Bedding appropriate to the weather and climate.
    (iv) Functional furniture appropriate to the patient's needs and 
individual closet space with clothes racks and shelves accessible to the 
patient.
    (3) HCFA may permit variances in requirements specified in 
paragraphs (b)(1)(i) and (ii) of this section relating to rooms on an 
individual basis when the RNHCI adequately demonstrates in writing that 
the variances meet the following:
    (i) Are in accordance with the special needs of the patients.
    (ii) Will not adversely affect patients' health and safety.



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

    (a) General. An RNHCI must meet the following conditions:
    (1) Except as provided in paragraph (b) of this section, the RNHCI 
must meet the new or existing health care occupancies provisions of the 
1997 edition of the Life Safety Code of the National Fire Protection 
Association (NFPA 101), which is incorporated by

[[Page 58]]

reference. Incorporation by reference of NFPA 101, the Life Safety Code, 
1997 edition, was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.\1\ (See Sec. 483.70).
---------------------------------------------------------------------------

    \1\ The 1997 edition of the Life Safety Code (NFPA 101) is available 
for inspection at the HCFA Information Resource Center, 7500 Security 
Boulevard, Central Building, Baltimore, MD, and at the Office of the 
Federal Register, 800 North Capitol Street, NW, suite 700, Washington, 
DC. Copies of this publication may be purchased from the National Fire 
Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 
02263-9101.
---------------------------------------------------------------------------

    (2) The RNHCI must have written fire control plans that contain 
provisions for prompt reporting of fires; extinguishing fires; 
protection of patients, staff, and the public; evacuation; and 
cooperation with fire fighting authorities.
    (3) The RNHCI must maintain written evidence of regular inspection 
and approval by State or local fire control agencies.
    (b) Exceptions. (1) If application of the Life Safety Code required 
under paragraph (a)(1) of this section would result in unreasonable 
hardship upon the RNHCI, HCFA may waive specific provisions of the Life 
Safety Code, but only if the waiver does not adversely affect the health 
and safety of patients.
    (2) If HCFA finds that the fire and safety code imposed by State law 
adequately protects patients in the institution, the provisions of the 
Life Safety Code required in paragraph (a)(1) of this section do not 
apply in that State.



Sec. 403.746  Condition of participation: Utilization review.

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



Sec. 403.750  Estimate of expenditures and adjustments.

    (a) Estimates. HCFA estimates the level of expenditures for services 
provided under this subpart before the start of each FFY beginning with 
FFY 2000.
    (b) Adjustments to payments. When the level of estimated 
expenditures is projected to exceed the FFY trigger level as described 
in paragraph (d) of this section, for the year of the projection, 
payments to RNHCIs will be reduced by a proportional percentage to 
prevent estimated expenditures from exceeding the trigger level. In 
addition to reducing payments proportionally, HCFA may impose 
alternative adjustments.
    (c) Notification of adjustments. HCFA notifies participating RNHCIs 
before the start of the FFY of the type and level of expenditure 
reductions to be made and when these adjustments will apply.
    (d) Calculation of trigger level. The trigger level for FFY 1998 is 
$20,000,000. For subsequent FFYs, the trigger level is the unadjusted 
trigger level increased or decreased by the carry forward as described 
in Sec. 403.754(b). The unadjusted trigger level is the base year amount 
(the unadjusted trigger level dollar amount for the prior FFY) increased 
by the average consumer price index (the single numerical value 
published monthly by the Bureau of Labor Statistics that presents the 
relationship in United States urban areas for the current cost of goods 
and services compared to a base year, to represent the change in 
spending power) for the 12-month period ending on July 31 preceding the 
beginning of the FFY.

[[Page 59]]



Sec. 403.752  Payment provisions.

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



Sec. 403.754  Monitoring expenditure level.

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



Sec. 403.756  Sunset provision.

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

[[Page 60]]





                     SUBCHAPTER B--MEDICARE PROGRAM


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




Subpart A--[Reserved]

  Subpart B--Medical Services Coverage Decisions That Relate to Health 
                             Care Technology

Sec.
405.201  Scope of subpart and definitions.
405.203  FDA categorization of investigational devices.
405.205  Coverage of a non-experimental/investigational (Category B) 
          device.
405.207  Services related to a noncovered device.
405.209  Payment for a non-experimental/investigational (Category B) 
          device.
405.211  Procedures for Medicare contractors in making coverage 
          decisions for a non-experimental/investigational (Category B) 
          device.
405.213  Re-evaluation of a device categorization.
405.215  Confidential commercial and trade secret information.

    Subpart C--Suspension of Payment, Recovery of Overpayments, and 
                   Repayment of Scholarships and Loans

                           General Provisions

405.301  Scope of subpart.

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

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

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

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

                   Repayment of Scholarships and Loans

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

                      Subpart D--Private Contracts

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

         Subpart E--Criteria for Determining Reasonable Charges

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

[[Page 61]]

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

Subpart F--[Reserved]

      Subpart G--Reconsiderations and Appeals Under Medicare Part A

405.701  Basis, purpose and definitions.
405.702  Notice of initial determination.
405.704  Actions which are initial determinations.
405.705  Actions which are not initial determinations.
405.706  Decisions of utilization review committees.
405.708  Effect of initial determination.
405.710  Right to reconsideration.
405.711  Time and place of filing request for reconsideration.
405.712  Extension of time to request reconsideration.
405.714  Withdrawal of request for reconsideration.
405.715  Reconsidered determination.
405.716  Notice of reconsidered determination.
405.717  Effect of a reconsidered determination.
405.718  Expedited appeals process.
405.720  Hearing; right to hearing.
405.722  Time and place of filing request for a hearing.
405.724  Departmental Appeals Board (DAB) review.
405.730  Court review.
405.732  Review of national coverage decisions (NCDs).
405.740  Principles for determining the amount in controversy.
405.745  Amount in controversy ascertained after reconsideration.
405.747  Dismissal of request for hearing; amount in controversy less 
          than $100.
405.750  Time period for reopening initial, revised, or reconsidered 
          determinations and decisions or revised decisions of an ALJ or 
          the Departmental Appeals Board (DAB); binding effect of 
          determination and decisions.
405.753  Appeal of a categorization of a device.

          Subpart H--Appeals Under the Medicare Part B Program

405.801  Part B appeals--general description.
405.802  Definitions.
405.803  Initial determination.
405.804  Notice of initial determination.
405.805  Parties to the initial determination.
405.806  Effect of initial determination.
405.807  Request for review of initial determination.
405.808  Parties to the review.
405.809  Opportunity to submit evidence.
405.810  Review determination.
405.811  Notice of review determination.
405.812  Effect of review determination.
405.815  Amount in controversy for carrier hearing, ALJ hearing and 
          judicial review.
405.817  Principles for determining amount in controversy.
405.821  Request for carrier hearing.
405.822  Parties to a carrier hearing.
405.823  Carrier hearing officer.
405.824  Disqualification of carrier hearing officer.
405.825  Location of carrier hearing.
405.826  Notice of carrier hearing.
405.830  Conduct of the carrier hearing.
405.831  Waiver of right to appear at carrier hearing and present 
          evidence.
405.832  Dismissal of request for carrier hearing.
405.833  Record of carrier hearing.
405.834  Carrier hearing officer's decision.
405.835  Effect of carrier hearing officer's decision.
405.836  Authority of the carrier hearing officer.
405.841  Reopening initial or review determination of the carrier, and 
          decision of a carrier hearing officer.
405.842  Notice of reopening and revision.
405.850  Change of ruling or legal precedent.
405.853  Expedited appeals process.
405.855  ALJ hearing.
405.856  Departmental Appeals Board (DAB) review.
405.857  Court review.
405.860  Review of national coverage decisions (NCDs).
405.870  Appointment of representative.
405.871  Qualifications of representatives.
405.872  Authority of representatives.
405.874  Appeals of carrier decisions that supplier standards are not 
          met.

[[Page 62]]

405.877  Appeal of a categorization of a device.

Subparts I-Q--[Reserved]

      Subpart R--Provider Reimbursement Determinations and Appeals

405.1801  Introduction.
405.1803  Intermediary determination and notice of amount of program 
          reimbursement.
405.1804  Matters not subject to administrative or judicial review under 
          prospective payment.
405.1805  Parties to intermediary determination.
405.1807  Effect of intermediary determination.
405.1809  Intermediary hearing procedures.
405.1811  Right to intermediary hearing; time, place, form, and content 
          of request for intermediary hearing.
405.1813  Failure to timely request an intermediary hearing.
405.1815  Parties to the intermediary hearing.
405.1817  Hearing officer or panel of hearing officers authorized to 
          conduct intermediary hearing; disqualification of officers.
405.1819  Conduct of intermediary hearing.
405.1821  Prehearing discovery and other proceedings prior to the 
          intermediary hearing.
405.1823  Evidence at intermediary hearing.
405.1825  Witnesses at intermediary hearing.
405.1827  Record of intermediary hearing.
405.1829  Authority of hearing officer(s) at intermediary hearing.
405.1831  Intermediary hearing decision and notice.
405.1833  Effect of intermediary hearing decision.
405.1835  Right to Board hearing.
405.1837  Group appeal.
405.1839  Amount in controversy.
405.1841  Time, place, form, and content of request for Board hearing.
405.1842  Expediting Board proceedings.
405.1843  Parties to Board hearing.
405.1845  Composition of Board.
405.1847  Disqualification of Board members.
405.1849  Establishment of time and place of hearing by the Board.
405.1851  Conduct of Board hearing.
405.1853  Prehearing discovery and other proceedings prior to the Board 
          hearing.
405.1855  Evidence at Board hearing.
405.1857  Subpoenas.
405.1859  Witnesses.
405.1861  Oral argument and written allegations.
405.1863  Administrative policy at issue.
405.1865  Record of Board hearing.
405.1867  Sources of Board's authority.
405.1869  Scope of Board's decision-making authority.
405.1871  Board hearing decision and notice.
405.1873  Board's jurisdiction.
405.1875  Administrator's review.
405.1877  Judicial review.
405.1881  Appointment of representative.
405.1883  Authority of representative.
405.1885  Reopening a determination or decision.
405.1887  Notice of reopening.
405.1889  Effect of a revision.

Subparts S-T--[Reserved]

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

405.2100  Scope of subpart.
405.2101  Objectives of the end-stage renal disease (ESRD) program.
405.2102  Definitions.
405.2110  Designation of ESRD networks.
405.2111  [Reserved]
405.2112  ESRD network organizations.
405.2113  Medical review board.
405.2114  [Reserved]
405.2120  Minimum utilization rates: general.
405.2121  Basis for determining minimum utilization rates.
405.2122  Types and duration of classification according to utilization 
          rates.
405.2123  Reporting of utilization rates for classification.
405.2124  Calculation of utilization rates for comparison with minimal 
          utilization rates(s) and notification of status.
405.2130  Condition: Minimum utilization rates.
405.2131  Condition: Provider status: Renal transplantation center or 
          renal dialysis center.
405.2132  [Reserved]
405.2133  Condition: Furnishing data and information for ESRD program 
          administration.
405.2134  Condition: Participation in network activities.
405.2135  Condition: Compliance with Federal, State, and local laws and 
          regulations.
405.2136  Condition: Governing body and management.
405.2137  Condition: Patient long-term program and patient care plan.
405.2138  Condition: Patients' rights and responsibilities.
405.2139  Condition: Medical records.
405.2140  Condition: Physical environment.
405.2150  Condition: Reuse of hemodialyzers and other dialysis supplies.
405.2160  Condition: Affiliation agreement or arrangement.
405.2161  Condition: Director of a renal dialysis facility or renal 
          dialysis center.

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405.2162  Condition: Staff of a renal dialysis facility or renal 
          dialysis center.
405.2163  Condition: Minimal service requirements for a renal dialysis 
          facility or renal dialysis center.
405.2164  Conditions for coverage of special purpose renal dialysis 
          facilities.
405.2170  Condition: Director of a renal transplantation center.
405.2171  Condition: Minimal service requirements for a renal 
          transplantation center.
405.2180  Termination of Medicare coverage.
405.2181  Alternative sanctions.
405.2182  Notice of sanction and appeal rights: Termination of coverage.
405.2184  Notice of appeal rights: Alternative sanctions.

Subparts V-W--[Reserved]

  Subpart X--Rural Health Clinic and Federally Qualified Health Center 
                                Services

405.2400  Basis.
405.2401  Scope and definitions.
405.2402  Basic requirements.
405.2403  Content and terms of the agreement with the Secretary.
405.2404  Terminations of agreements.
405.2410  Application of Part B deductible and coinsurance.
405.2411  Scope of benefits.
405.2412  Physicians' services.
405.2413  Services and supplies incident to a physician's services.
405.2414  Nurse practitioner and physician assistant services.
405.2415  Services and supplies incident to nurse practitioner and 
          physician assistant services.
405.2416  Visiting nurse services.
405.2417  Visiting nurse services: Determination of shortage of 
          agencies.

               Federally Qualified Health Center Services

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

 Payment for Rural Health Clinic and Federally Qualified Health Center 
                                Services

405.2460  Applicability of general payment exclusions.
405.2462  Payment for rural health clinic and Federally qualified health 
          center services.
405.2463  What constitutes a visit.
405.2464  All-inclusive rate.
405.2466  Annual reconciliation.
405.2468  Allowable costs.
405.2470  Reports and maintenance of records.
405.2472  Beneficiary appeals.

    Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, 1881, and 1886(k) 
of the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh, 
1395kk, 1395rr and 1395ww(k)), and sec. 353 of the Public Health Service 
Act (42 U.S.C. 263a).

Subpart A--[Reserved]



  Subpart B--Medical Services Coverage Decisions That Relate to Health 
                             Care Technology

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

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



Sec. 405.201  Scope of subpart and definitions.

    (a) Scope. This subpart establishes that--
    (1) HCFA uses the FDA categorization of a device as a factor in 
making Medicare coverage decisions; and
    (2) HCFA may consider for Medicare coverage certain devices with an 
FDA-approved investigational device exemption (IDE) that have been 
categorized as non-experimental/investigational (Category B).
    (b) Definitions. As used in this subpart--
    Class I refers to devices for which the general controls of the 
Food, Drug, and Cosmetic Act, such as adherence to good manufacturing 
practice regulations, are sufficient to provide a reasonable assurance 
of safety and effectiveness.
    Class II refers to devices that, in addition to general controls, 
require special controls, such as performance standards or postmarket 
surveillance, to provide a reasonable assurance of safety and 
effectiveness.
    Class III refers to devices that cannot be classified into Class I 
or Class II because insufficient information exists to

[[Page 64]]

determine that either special or general controls would provide 
reasonable assurance of safety and effectiveness. Class III devices 
require premarket approval.
    Contractors refers to carriers, fiscal intermediaries, and other 
entities that contract with HCFA to review and adjudicate claims for 
Medicare services.
    Experimental/investigational (Category A) device refers to an 
innovative device believed to be in Class III for which ``absolute 
risk'' of the device type has not been established (that is, initial 
questions of safety and effectiveness have not been resolved and the FDA 
is unsure whether the device type can be safe and effective).
    IDE stands for investigational device exemption. An FDA-approved IDE 
application permits a device, which would otherwise be subject to 
marketing clearance, to be shipped lawfully for the purpose of 
conducting a clinical trial in accordance with 21 U.S.C. 360j(g) and 21 
CFR parts 812 and 813.
    Non-experimental/investigational (Category B) device refers to a 
device believed to be in Class I or Class II, or a device believed to be 
in Class III for which the incremental risk is the primary risk in 
question (that is, underlying questions of safety and effectiveness of 
that device type have been resolved), or it is known that the device 
type can be safe and effective because, for example, other manufacturers 
have obtained FDA approval for that device type.
    PMA stands for ``premarket approval'' and refers to a marketing 
application for a Class III device, which includes all information 
submitted with or incorporated by reference in the application in 
accordance with 21 U.S.C. 360e and 360j and 21 CFR 814.3(e).
    Sponsor refers to a person or entity that initiates, but does not 
conduct, an investigation under an IDE.



Sec. 405.203  FDA categorization of investigational devices.

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



Sec. 405.205  Coverage of a non-experimental/investigational (Category B) device.

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



Sec. 405.207  Services related to a noncovered device.

    (a) When payment is not made. Medicare payment is not made for 
medical and hospital services that are related to the use of a device 
that is not covered because HCFA determines the device is not 
``reasonable'' and ``necessary'' under section 1862(a)(1)(A) of the Act 
or because it is excluded from coverage for other reasons. These 
services include all services furnished in preparation for the use of a 
noncovered device, services furnished contemporaneously with and 
necessary to the use of a noncovered device, and services furnished as 
necessary after-care that are incident to recovery from the use of the 
device or from receiving related noncovered services.
    (b) When payment is made. Medicare payment may be made for services, 
ordinarily covered by Medicare, to treat a condition or complication 
that arises

[[Page 65]]

because of the use of a noncovered device or from the furnishing of 
related noncovered services.



Sec. 405.209  Payment for a non-experimental/investigational (Category B) device.

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



Sec. 405.211  Procedures for Medicare contractors in making coverage decisions for a non-experimental/investigational (Category B) device.

    (a) General rule. In their review of claims for payment, Medicare 
contractors are bound by the statute, regulations, and all HCFA 
administrative issuances, including all national coverage decisions.
    (b) Potentially covered non-experimental/investigational (Category 
B) devices. Medicare contractors may approve coverage for any device 
with an FDA-approved IDE categorized as a non-experimental/
investigational (Category B) device if all other coverage requirements 
are met.
    (c) Other considerations. Medicare contractors must consider whether 
any restrictions concerning site of service, indications for use, or any 
other list of conditions for coverage have been placed on the device's 
use.



Sec. 405.213  Re-evaluation of a device categorization.

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



Sec. 405.215  Confidential commercial and trade secret information.

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



    Subpart C--Suspension of Payment, Recovery of Overpayments, and 
                   Repayment of Scholarships and Loans

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

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

[[Page 66]]

                           General Provisions



Sec. 405.301  Scope of subpart.

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

[54 FR 41733, Oct. 11, 1989]

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



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

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

[41 FR 1492, Jan. 8, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 61 FR 49271, Sept. 19, 1996]



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

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



Sec. 405.352  Adjustment of title XVIII incorrect payments.

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

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



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

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



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

    The procedures applied in making an adjustment or recovery in the 
case of a title II beneficiary are the applicable procedures of 20 CFR 
404.502.

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

[[Page 67]]



Sec. 405.355  Waiver of adjustment or recovery.

    (a) The provisions of Sec. 405.352 may not be applied and there may 
be no adjustment or recovery of an incorrect payment (i.e., a payment 
made under Sec. 405.350(a) or Sec. 405.350(b)) in any case where such 
incorrect payment has been made with respect to an individual who is 
without fault, or where such adjustment or recovery would be made by 
decreasing payments to which another person who is without fault is 
entitled as provided in section 1870(b) of the Act where such adjustment 
or recovery would defeat the purpose of title II or title XVIII of the 
Act or would be against equity and good conscience. (See 20 CFR 404.509 
and 404.512.)
    (b) Adjustment or recovery of an incorrect payment (or only such 
part of an incorrect payment as may be determined to be inconsistent 
with the purposes of Title XVIII of the Act) against an individual who 
is without fault shall be deemed to be against equity and good 
conscience if the determination that such payment was incorrect was made 
subsequent to the third year following the year in which notice of such 
payment was sent to such individual. (See Secs. 405.330-405.332 for 
conditions under which payment may be made for items or services 
furnished after October 30, 1972 which are noncovered by reasons of 
Sec. 405.310 (g) and (k).)

[41 FR 1493, Jan. 8, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977]



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

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

[61 FR 49271, Sept. 19, 1996]



Sec. 405.357  Notice of right to waiver consideration.

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

[61 FR 49271, Sept. 19, 1996]



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

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

[61 FR 49271, Sept. 19, 1996]



Sec. 405.359  Liability of certifying or disbursing officer.

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

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



Sec. 405.370   Definitions.

    For purposes of this subpart, the following definitions apply:
    Offset. The recovery by Medicare of a non-Medicare debt by reducing 
present or future Medicare payments and applying the amount withheld to 
the indebtedness. (Examples are Public Health Service debts or Medicaid 
debts recovered by HCFA).
    Recoupment. The recovery by Medicare of any outstanding Medicare 
debt by reducing present or future Medicare payments and applying the 
amount withheld to the indebtedness.
    Suspension of payment. The withholding of payment by an intermediary

[[Page 68]]

or carrier from a provider or supplier of an approved Medicare payment 
amount before a determination of the amount of the overpayment exists.

[61 FR 63745, Dec. 2, 1996]



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

    (a) General. Medicare payments to providers and suppliers, as 
authorized under this subchapter (excluding payments to beneficiaries), 
may be--
    (1) Suspended, in whole or in part, by HCFA, an intermediary, or a 
carrier if HCFA, the intermediary, or the carrier possesses reliable 
information that an overpayment or fraud or willful misrepresentation 
exists or that the payments to be made may not be correct, although 
additional evidence may be needed for a determination; or
    (2) Offset or recouped, in whole or in part, by an intermediary or a 
carrier if the intermediary, carrier, or HCFA has determined that the 
provider or supplier to whom payments are to be made has been overpaid.
    (b) Steps necessary for suspension of payment, offset, and 
recoupment. Except as provided in paragraph (c) of this section, HCFA, 
the intermediary, or carrier suspends payments only after it has 
complied with the procedural requirements set forth at Sec. 405.372. The 
intermediary or carrier offsets or recoups payments only after it has 
complied with the procedural requirements set forth at Sec. 405.373.
    (c) Suspension of payment in the case of unfiled cost reports. If a 
provider has failed to timely file an acceptable cost report, payment to 
the provider is immediately suspended until a cost report is filed and 
determined by the intermediary to be acceptable. In the case of an 
unfiled cost report, the provisions of Sec. 405.372 do not apply. (See 
Sec. 405.372(a)(2) concerning failure to furnish other information.)

[61 FR 63746, Dec. 2, 1996]



Sec. 405.372   Proceeding for suspension of payment.

    (a) Notice of intention to suspend--(1) General rule. Except as 
provided in paragraphs (a)(2) through (a)(4) of this section, if the 
intermediary, carrier, or HCFA has determined that a suspension of 
payments under Sec. 405.371(a)(1) should be put into effect, the 
intermediary or carrier must notify the provider or supplier of the 
intention to suspend payments, in whole or in part, and the reasons for 
making the suspension.
    (2) Failure to furnish information. The notice requirement of 
paragraph (a)(1) of this section does not apply if the intermediary or 
carrier suspends payments to a provider or supplier in accordance with 
section 1815(a) or section 1833(e) of the Act, respectively, because the 
provider or supplier has failed to submit information requested by the 
intermediary or carrier that is needed to determine the amounts due the 
provider or supplier. (See Sec. 405.371(c) concerning failure to file 
timely acceptable cost reports.)
    (3) Harm to Trust Funds. A suspension of payment may be imposed 
without prior notice if HCFA, the intermediary, or carrier determines 
that the Medicare Trust Funds would be harmed by giving prior notice. 
HCFA may base its determination on an intermediary's or carrier's belief 
that giving prior notice would hinder the possibility of recovering the 
money.
    (4) Fraud or misrepresentation. If the intended suspension of 
payment involves suspected fraud or misrepresentation, HCFA determines 
whether to impose the suspension and if prior notice is appropriate. 
HCFA directs the intermediary or carrier as to the timing and content of 
the notification to the provider or supplier. HCFA is the real party in 
interest and is responsible for the decision. HCFA may base its decision 
on information from the intermediary, carrier, law enforcement agencies, 
or other sources. HCFA determines whether the information is reliable.
    (b) Rebuttal--(1) If prior notice is required. If prior notice is 
required under paragraph (a) of this section, the intermediary or 
carrier must give the provider or supplier an opportunity for rebuttal 
in accordance with Sec. 405.374. If a rebuttal statement is received 
within the specified time period, the suspension of payment goes into 
effect on the date stated in the notice, and the procedures and 
provisions set forth in

[[Page 69]]

Sec. 405.375 apply. If by the end of the period specified in the notice 
no statement has been received, the suspension goes into effect 
automatically, and the procedures set forth in paragraph (c) of this 
section are followed.
    (2) If prior notice is not required. If, under the provisions of 
paragraphs (a)(2) through (a)(4) of this section, a suspension of 
payment is put into effect without prior notice to the provider or 
supplier, the intermediary or carrier must, once the suspension is in 
effect, give the provider or supplier an opportunity to submit a 
rebuttal statement as to why the suspension should be removed.
    (c) Subsequent action. If a suspension of payment is put into 
effect, the intermediary, carrier, or HCFA takes timely action after the 
suspension to obtain the additional evidence it may need to make a 
determination as to whether an overpayment exists or the payments may be 
made. The intermediary, carrier, or HCFA makes all reasonable efforts to 
expedite the determination. As soon as the determination is made, the 
intermediary or carrier informs the provider or supplier and, if 
appropriate, the suspension is rescinded or any existing recoupment or 
offset is adjusted to take into account the determination.
    (d) Duration of suspension of payment--(1) General rule. Except as 
provided in paragraphs (d)(2) and (d)(3) of this section, a suspension 
of payment is limited to 180 days, starting with the date the suspension 
begins.
    (2) 180-day extension. (i) An intermediary, a carrier, or, in cases 
of fraud and misrepresentation, OIG or a law enforcement agency, may 
request a one-time only extension of the suspension period for up to 180 
additional days if it is unable to complete its examination of the 
information or investigation, as appropriate, within the 180-day time 
limit. The request must be submitted in writing to HCFA.
    (ii) Upon receipt of a request for an extension, HCFA notifies the 
provider or supplier of the requested extension. HCFA then either 
extends the suspension of payment for up to an additional 180 days or 
determines that the suspended payments are to be released to the 
provider or supplier.
    (3) Exceptions to the time limits. (i) The time limits specified in 
paragraphs (d)(1) and (d)(2) of this section do not apply if the case 
has been referred to, and is being considered by, the OIG for 
administrative action (for example, civil money penalties).
    (ii) HCFA may grant an extension in addition to the extension 
provided under paragraph (d)(2) of this section if the Department of 
Justice submits a written request to HCFA that the suspension of payment 
be continued based on the ongoing investigation and anticipated filing 
of criminal and/or civil actions. At a minimum, the request must include 
the following:
    (A) Identification of the entity under suspension.
    (B) The amount of time needed for continued suspension in order to 
implement the criminal and/or civil proceedings.
    (C) A statement of why and/or how criminal and/or civil actions may 
be affected if the requested extension is not granted.
    (e) Disposition of suspended payments. Payments suspended under the 
authority of Sec. 405.371(b) are first applied to reduce or eliminate 
any overpayments determined by the intermediary, carrier, or HCFA, 
including any interest assessed under the provisions of Sec. 405.378, 
and then applied to reduce any other obligation to HCFA or to HHS. In 
the absence of a legal requirement that the excess be paid to another 
entity, the excess is released to the provider or supplier.

[61 FR 63746, Dec. 2, 1996]



Sec. 405.373  Proceeding for offset or recoupment.

    (a) General rule. Except as specified in paragraph (b) of this 
section, if the intermediary, carrier, or HCFA has determined that an 
offset or recoupment of payments under Sec. 405.371(a)(2) should be put 
into effect, the intermediary or carrier must--
    (1) Notify the provider or supplier of its intention to offset or 
recoup payment, in whole or in part, and the reasons for making the 
offset or recoupment; and
    (2) Give the provider or supplier an opportunity for rebuttal in 
accordance with Sec. 405.374.

[[Page 70]]

    (b) Paragraph (a) of this section does not apply if the 
intermediary, after furnishing a provider a written notice of the amount 
of program reimbursement in accordance with Sec. 405.1803, recoups 
payment under paragraph (c) of Sec. 405.1803. (For provider rights in 
this circumstance, see Secs. 405.1809, 405.1811, 405.1815, 405.1835, and 
405.1843.)
    (c) Actions following receipt of rebuttal statement. If a provider 
or supplier submits, in accordance with Sec. 405.374, a statement as to 
why an offset or recoupment should not be put into effect on the date 
specified in the notice, the intermediary or carrier must comply with 
the time limits and notification requirements of Sec. 405.375.
    (d) No rebuttal statement received. If, by the end of the time 
period specified in the notice, no statement has been received, the 
recoupment or offset goes into effect automatically.
    (e) Duration of recoupment or offset. If a recoupment or offset is 
put into effect, it remains in effect until the earliest of the 
following:
    (1) The overpayment and any assessed interest are liquidated.
    (2) The intermediary or carrier obtains a satisfactory agreement 
from the provider or supplier for liquidation of the overpayment.
    (3) The intermediary or carrier, on the basis of subsequently 
acquired evidence or otherwise, determines that there is no overpayment.

[61 FR 63747, Dec. 2, 1996]



Sec. 405.374  Opportunity for rebuttal.

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

[61 FR 63747, Dec. 2, 1996]



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

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

[61 FR 63747, Dec. 2, 1996]



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

    (a) Basis and purpose. This section contains requirements and 
procedures for the compromise of, or suspension or termination of 
collection action on, claims for overpayments against a provider or a 
supplier under the Medicare

[[Page 71]]

program. It is adopted under the authority of the Federal Claims 
Collection Act (31 U.S.C. 3711). Collection and compromise of claims 
against Medicare beneficiaries are explained at 20 CFR 404.515.
    (b) Definitions. As used in this section, debtor means a provider of 
services or a physician or other supplier of services that has been 
overpaid under title XVIII of the Social Security Act. It includes an 
individual, partnership, corporation, estate, trust, or other legal 
entity.
    (c) Basic conditions. A claim for recovery of Medicare overpayments 
against a debtor may be compromised, or collection action on it may be 
suspended or terminated, by the Health Care Financing Administration 
(HCFA) if;
    (1) The claim does not exceed $100,000, or such higher amount as the 
Attorney General may from time to time prescribe, exclusive of interest; 
and
    (2) There is no indication of fraud, the filing of a false claim, or 
misrepresentation on the part of the debtor or any director, partner, 
manager, or other party having an interest in the claim.
    (d) Basis for compromise. A claim may be compromised for one or more 
of the following reasons:
    (1) The debtor, or the estate of a deceased debtor, does not have 
the present or prospective ability to pay the full amount within a 
reasonable time;
    (2) The debtor refuses to pay the claim in full and the United 
States is unable to collect the full amount within a reasonable time by 
legal proceedings;
    (3) There is real doubt the United States can prove its case in 
court; or
    (4) The cost of collecting the claim does not justify enforced 
collection of the full amount.
    (e) Basis for termination of collection action.  Collection action 
may be terminated for one or more of the following reasons:
    (1) The United States cannot enforce collection of any significant 
sum;
    (2) The debtor cannot be located, there is no security to be 
liquidated, the statute of limitations has run, and the prospects of 
collecting by offset are too remote to justify retention of the claim;
    (3) The cost of further collection action is likely to exceed any 
recovery;
    (4) It is determined the claim is without merit; or
    (5) Evidence to substantiate the claim is no longer available.
    (f) Basis for suspension of collection action. Collection action may 
be suspended for either of the following reasons if future collection 
action is justified based on potential productivity, including 
foreseeable ability to pay, and size of claim:
    (1) The debtor cannot be located; or
    (2) The debtor is unable to make payments on the claim or to fulfill 
an acceptable compromise.
    (g) Factors considered. In determining whether a claim will be 
compromised, or collection action terminated or suspended, HCFA will 
consider the following factors:
    (1) Age and health of the debtor, present and potential income, 
inheritance prospects, possible concealment or fraudulent transfer of 
assets, and the availability of assets which may be reached by enforced 
collection proceedings, for compromise under paragraph (d)(1) of this 
section, termination under paragraph (e)(1) of this section, and 
suspension under paragraph (f)(2) of this section;
    (2) Applicable exemptions available to a debtor and uncertainty 
concerning the price of the property in a forced sale, for compromise 
under paragraph (d)(2) of this section and termination under paragraph 
(e)(1) of this section; and
    (3) The probability of proving the claim in court, the probability 
of full or partial recovery, the availability of necessary evidence, and 
related pragmatic considerations, for compromise under paragraph (d)(3) 
of this section.
    (h) Amount of compromise. The amount accepted in compromise will be 
reasonable in relation to the amount that can be recovered by enforced 
collection proceedings.

Consideration shall be given to the following:
    (1) The exemptions available to the debtor under State or Federal 
law;
    (2) The time necessary to collect the overpayment;

[[Page 72]]

    (3) The litigative probabilities involved; and
    (4) The administrative and litigative costs of collection where the 
cost of collecting the claim is a basis for compromise.
    (i) Payment of compromise--(1) Time and manner. Payment of the 
amount that HCFA has agreed to accept as a compromise in full settlement 
of a Medicare overpayment claim must be made within the time and in the 
manner prescribed by HCFA. An overpayment claim is not compromised or 
settled until the full payment of the compromised amount has been made 
within the time and in the manner prescribed by HCFA.
    (2) Failure to pay compromised amount. Failure of the debtor or the 
estate to make payment as provided by the comprise reinstates the full 
amount of the overpayment claim, less any amounts paid prior to the 
default.
    (j) Effect of compromise, or suspension, or termination of 
collection action. Any action taken by HCFA under this section regarding 
the compromise of an overpayment claim, or termination or suspension of 
collection action on an overpayment claim, is not an initial 
determination for purposes of the appeal procedures under subparts G, H, 
and R of this part.

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



Sec. 405.377  Withholding Medicare payments to recover Medicaid overpayments.

    (a) Basis and purpose. This section implements section 1885 of the 
Act, which provides for withholding Medicare payments to certain 
Medicaid providers that have not arranged to repay Medicaid overpayments 
as determined by the Medicaid State agency or have failed to provide 
information necessary to determine the amount (if any) of overpayments.
    (b) When withholding may be used. HCFA may withhold Medicare payment 
to offset Medicaid overpayments that a Medicaid agency has been unable 
to collect if--
    (1) The Medicaid agency has followed the procedure specified in 
Sec. 447.31 of this chapter; and
    (2) The institution or person is one described in paragraph (c) of 
this section and either--
    (i) Has not made arrangements satisfactory to the Medicaid agency to 
repay the overpayment; or
    (ii) Has not provided information to the Medicaid agency necessary 
to enable the agency to determine the existence or amount of Medicaid 
overpayment.
    (c) Institutions or persons affected. Withholding under paragraph 
(b) of this section may be made with respect to any of the following 
entities that has or had in effect an agreement with a Medicaid agency 
to furnish services under an approved Medicaid State plan:
    (1) An institutional provider that has in effect an agreement under 
section 1866 of the Act. (Part 489 (Provider and Supplier Agreements) 
implements section 1866 of the Act.)
    (2) A physician or supplier that has accepted payment on the basis 
of an assignment under section 1842(b)(3)(B)(ii) of the Act. (Section 
424.55 sets forth the conditions a supplier agrees to in accepting 
assignment.)
    (d) Amount to be withheld. (1) HCFA contacts the appropriate 
intermediary or carrier to determine the amount of Medicare payment to 
which the institution or person is entitled.
    (2) HCFA may require the intermediary or carrier to withhold 
Medicare payments to the institution or person by the lesser of the 
following amounts:
    (i) The amount of the Medicare payments to which the institution or 
person would otherwise be entitled.
    (ii) The total Medicaid overpayment to the institution or person.
    (e) Notice of withholding. If HCFA intends to withhold payments 
under this section, it notifies by certified mail, return receipt 
requested, the institution or person and the appropriate intermediary or 
carrier of the intention to withhold Medicare payments and follows the 
procedure in Sec. 405.374. The notice includes--
    (1) Identification of the institution or person; and
    (2) The amount of Medicaid overpayment to be withheld from payments 
to which the institution or person would otherwise be entitled under 
Medicare.

[[Page 73]]

    (f) Termination of withholding. HCFA terminates the withholding if--
    (1) The Medicaid overpayment is completely recovered;
    (2) The institution or person enters into an agreement satisfactory 
to the Medicaid agency to repay the overpayment; or
    (3) The Medicaid agency determines that there is no overpayment 
based on newly acquired evidence or a subsequent audit.
    (g) Disposition of funds withheld. HCFA releases amounts withheld 
under this section to the Medicaid agency to be applied against the 
Medicaid overpayment made by the State agency.

[61 FR 63747, Dec. 2, 1996]



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

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

[[Page 74]]

specified in paragraphs (c)(1) (i), (ii), (iii), or (iv) of this 
section.)
    (2) Except as required by any subsequent administrative or judicial 
reversal, interest accrues from the date of final determination as 
specified in this subsection.
    (d) Rate of interest. (1) The interest rate on overpayments and 
underpayments is the higher of--
    (i) The rate as fixed by the Secretary of the Treasury after taking 
into consideration private consumer rates of interest prevailing on the 
date of final determination as defined in paragraph (c) of this section 
(this rate is published quarterly in the Federal Register by the 
Department under 45 CFR 30.13(a)); or
    (ii) The current value of funds rate (this rate is published 
annually in the Federal Register by the Secretary of the Treasury, 
subject to quarterly revisions).
    (2) [Reserved]
    (e) Accrual of interest. (1) If a cost report is filed that does not 
indicate an amount is due HCFA but the intermediary makes a final 
determination that an overpayment exists, or if a carrier makes a final 
determination that an overpayment to a physician or supplier exists, 
interest will accrue beginning with the date of such final 
determination. Interest will continue to accrue during periods of 
administrative and judicial appeal and until final disposition of the 
claim.
    (2)(i) If a cost report is filed and indicates that an amount is due 
HCFA, interest on the amount due will accrue from the due date of the 
cost report unless--
    (A) Full payment on the amount due accompanies the cost report; or
    (B) The provider and the intermediary agree in advance to liquidate 
the overpayment through a reduction in interim payments over the next 
30-day period.
    (ii) If the intermediary determines an additional overpayment during 
the cost settlement process, interest will accrue from the date of each 
determination.
    (iii) The interest rate on each of the final determinations of an 
overpayment will be the rate of interest in effect on the date the 
determination is made.
    (3) In the case of a cost report that is not filed on time, interest 
also will accrue on a determined overpayment from the day following the 
due date of the report (plus a single extension of time not to exceed 30 
days if granted for good cause, as specified in Sec. 413.24(f)) of this 
chapter, to the time the cost report is filed.
    (4) If an intermediary or a carrier makes a final determination that 
an underpayment exists, interest to the provider or the supplier will 
accrue from the date of notification of the underpayment.
    (f) Waiver of interest charges. (1) When an intermediary or a 
carrier makes a final determination that an overpayment or underpayment 
exists, as specified in paragraphs (e)(1), (e)(2)(ii), and (e)(4)--
    (i) Interest charges will be waived if the overpayment or 
underpayment is completely liquidated within 30 days from the date of 
the final determination.
    (ii) HCFA may waive interest charges if it determines that the 
administrative cost of collecting them exceeds the interest charges.
    (2) Interest will not be waived for that period of time during which 
the cost report was due but remained unfiled for more than 30 days, as 
specified in paragraph (e)(3) of this section.
    (g) Rules applicable to partial payments. If an overpayment is 
repaid in installments or recouped by withholding from several payments 
due the provider or supplier of services--
    (1) Each payment or recoupment will be applied first to accrued 
interest and then to the principal; and
    (2) After each payment or recoupment, interest will accrue on the 
remaining unpaid balance.
    (h) Exceptions to applicability. (1) The provisions of this section 
do not apply to the time period for which interest is payable under 
Sec. 413.64(j) of this chapter because the provider seeks judicial 
review of a decision of the Provider Reimbursement Review Board, or a 
subsequent reversal, affirmance, or modification of that decision by the 
Administrator. Prior to that time, until the provider seeks judicial 
review, interest

[[Page 75]]

accrues at the rate specified in this section on outstanding unpaid 
balances resulting from final determinations as defined in paragraph (c) 
of this section.
    (2) If an overpayment or an underpayment determination is reversed 
administratively or judicially, and the reversal is no longer subject to 
appeal, appropriate adjustments will be made with respect to the 
overpayment or underpayment and the amount of interest charged.
    (i) Nonallowable cost. As specified in Secs. 412.113 and 413.153 of 
this chapter, interest accrued on overpayments and interest on funds 
borrowed specifically to repay overpayments are not considered allowable 
costs, up to the amount of the overpayment, unless the provider had made 
a prior commitment to borrow funds for other purposes (for example, 
capital improvements).

(See Sec. 413.153(a)(2) of this chapter for exceptions based on 
administrative or judicial reversal.)

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

                   Repayment of Scholarships and Loans



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

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

[57 FR 19092, May 4, 1992]



                      Subpart D--Private Contracts

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

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

[[Page 76]]



Sec. 405.400  Definitions.

    For purposes of this subpart, the following definitions apply:
    Beneficiary means an individual who is enrolled in Part B of 
Medicare.
    Emergency care services means services furnished to an individual 
for treatment of an ``emergency medical condition'' as that term is 
defined in Sec. 422.2 of this chapter.
    Legal representative means one or more individuals who, as 
determined by applicable State law, has the legal authority to enter 
into the contract with the physician or practitioner on behalf of the 
beneficiary.
    Opt-out means the status of meeting the conditions specified in 
Sec. 405.410.
    Opt-out period means the 2-year period beginning on the effective 
date of the affidavit as specified by Sec. 405.410(c)(1) or 
Sec. 405.410(c)(2), as applicable.
    Participating physician means a ``physician'' as defined in this 
section who has signed an agreement to participate in Part B of 
Medicare.
    Physician means a doctor of medicine or a doctor of osteopathy who 
is currently licensed as that type of doctor in each State in which he 
or she furnishes services to patients.
    Practitioner means a physician assistant, nurse practitioner, 
clinical nurse specialist, certified registered nurse anesthetist, 
certified nurse midwife, clinical psychologist, or clinical social 
worker, who is currently legally authorized to practice in that capacity 
by each State in which he or she furnishes services to patients or 
clients.
    Private contract means a document that meets the criteria specified 
in Sec. 405.415.
    Properly opt-out means to complete, without defect, the requirements 
for opt-out as specified in Sec. 405.410.
    Properly terminate opt-out means to complete, without defect, the 
requirements for terminating opt-out as specified in Sec. 405.445.
    Urgent care services means services furnished to an individual who 
requires services to be furnished within 12 hours in order to avoid the 
likely onset of an emergency medical condition.



Sec. 405.405  General rules.

    (a) A physician or practitioner may enter into one or more private 
contracts with Medicare beneficiaries for the purpose of furnishing 
items or services that would otherwise be covered by Medicare, provided 
the conditions of this subpart are met.
    (b) A physician or practitioner who enters into at least one private 
contract with a Medicare beneficiary under the conditions of this 
subpart, and who submits one or more affidavits in accordance with this 
subpart, opts-out of Medicare for a 2-year period unless the opt-out is 
terminated early according to Sec. 405.445. The physician's or 
practitioner's opt-out may be renewed for subsequent 2-year periods.
    (c) Both the private contracts described in paragraph (a) of this 
section and the physician's or practitioner's opt-out described in 
paragraph (b) of this section are null and void if the physician or 
practitioner fails to properly opt-out in accordance with the conditions 
of this subpart.
    (d) Both the private contracts described in paragraph (a) of this 
section and the physician's or practitioner's opt-out described in 
paragraph (b) of this section are null and void for the remainder of the 
opt-out period if the physician or practitioner fails to remain in 
compliance with the conditions of this subpart during the opt-out 
period.
    (e) Services furnished under private contracts meeting the 
requirements of this subpart are not covered services under Medicare, 
and no Medicare payment will be made for such services either directly 
or indirectly, except as permitted in accordance with Sec. 405.435(c).



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

    The following conditions must be met for a physician or practitioner 
to properly opt-out of Medicare:
    (a) Each private contract between a physician or a practitioner and 
a Medicare beneficiary that is entered into prior to the submission of 
the affidavit described in paragraph (b) of this section must meet the 
specifications of Sec. 405.415.

[[Page 77]]

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



Sec. 405.415  Requirements of the private contract.

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

[[Page 78]]

furnish emergency or urgent care services to a Medicare beneficiary in 
accordance with Sec. 405.440.)
    (l) Be provided (a photocopy is permissible) to the beneficiary or 
to his or her legal representative before items or services are 
furnished to the beneficiary under the terms of the contract.
    (m) Be retained (original signatures of both parties required) by 
the physician or practitioner for the duration of the opt-out period.
    (n) Be made available to HCFA upon request.
    (o) Be entered into for each opt-out period.



Sec. 405.420  Requirements of the opt-out affidavit.

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



Sec. 405.425  Effects of opting-out of Medicare.

    If a physician or practitioner opts-out of Medicare in accordance 
with this subpart for the 2-year period for which the opt-out is 
effective, the following results obtain:
    (a) Except as provided in Sec. 405.440, no payment may be made 
directly by

[[Page 79]]

Medicare or by any Medicare+Choice plan to the physician or practitioner 
or to any entity to which the physician or practitioner reassigns his 
right to receive payment for services.
    (b) The physician or practitioner may not furnish any item or 
service that would otherwise be covered by Medicare (except for 
emergency or urgent care services) to any Medicare beneficiary except 
through a private contract that meets the requirements of this subpart.
    (c) The physician or practitioner is not subject to the requirement 
to submit a claim for items or services furnished to a Medicare 
beneficiary, as specified in Sec. 424.5(a)(6) of this chapter, except as 
provided in Sec. 405.440.
    (d) The physician or practitioner is prohibited from submitting a 
claim to Medicare for items or services furnished to a Medicare 
beneficiary except as provided in Sec. 405.440.
    (e) In the case of a physician, he or she is not subject to the 
limiting charge provisions of Sec. 414.48 of this chapter, except for 
services provided under Sec. 405.440.
    (f) The physician or practitioner is not subject to the prohibition-
on-reassignment provisions of Sec. 414.80 of this chapter, except for 
services provided under Sec. 405.440.
    (g) In the case of a practitioner, he or she is not prohibited from 
billing or collecting amounts from beneficiaries (as provided in 42 
U.S.C. 1395u(b)(18)(B)).
    (h) The death of a beneficiary who has entered into a private 
contract (or whose legal representative has done so) does not invoke 
Sec. 424.62 or Sec. 424.64 of this chapter with respect to the physician 
or practitioner with whom the beneficiary (or legal representative) has 
privately contracted.
    (i) The physician or practitioner who has not been excluded under 
sections 1128, 1156, or 1892 of the Social Security Act may order, 
certify the need for, or refer a beneficiary for Medicare-covered items 
and services, provided the physician or practitioner is not paid, 
directly or indirectly, for such services (except as provided in 
Sec. 405.440).
    (j) The physician or practitioner who is excluded under sections 
1128, 1156, or 1892 of the Social Security Act may not order, prescribe, 
or certify the need for Medicare-covered items and services except as 
provided in Sec. 1001.1901 of this title, and must otherwise comply with 
the terms of the exclusion in accordance with Sec. 1001.1901 effective 
with the date of the exclusion.



Sec. 405.430  Failure to properly opt-out.

    (a) A physician or practitioner fails to properly opt-out if--
    (1) Any private contract between the physician or practitioner and a 
Medicare beneficiary, that was entered into before the affidavit 
described in Sec. 405.420 was filed, does not meet the specifications of 
Sec. 405.415; or
    (2) He or she fails to submit the affidavit(s) in accordance with 
Sec. 405.420.
    (b) If a physician or practitioner fails to properly opt-out in 
accordance with paragraph (a) of this section, the following results 
obtain:
    (1) The physician's or practitioner's attempt to opt-out of Medicare 
is nullified, and all of the private contracts between the physician or 
practitioner and Medicare beneficiaries for the two-year period covered 
by the attempted opt-out are deemed null and void.
    (2) The physician or practitioner must submit claims to Medicare for 
all Medicare-covered items and services furnished to Medicare 
beneficiaries, including the items and services furnished under the 
nullified contracts. A nonparticipating physician is subject to the 
limiting charge provisions of Sec. 414.48 of this chapter. A 
participating physician is subject to the limitations on charges of the 
participation agreement he or she signed.
    (3) The practitioner may not reassign any claim except as provided 
in Sec. 424.80 of this chapter.
    (4) The practitioner may neither bill nor collect an amount from the 
beneficiary except for applicable deductible and coinsurance amounts.
    (5) The physician or practitioner may make another attempt to 
properly opt-out at any time.



Sec. 405.435  Failure to maintain opt-out.

    (a) A physician or practitioner fails to maintain opt-out under this 
subpart if, during the opt-out period--
    (1) He or she knowingly and willfully--

[[Page 80]]

    (i) Submits a claim for Medicare payment (except as provided in 
Sec. 405.440); or
    (ii) Receives Medicare payment directly or indirectly for Medicare-
covered services furnished to a Medicare beneficiary (except as provided 
in Sec. 405.440).
    (2) He or she fails to enter into private contracts with Medicare 
beneficiaries for the purpose of furnishing items and services that 
would otherwise be covered by Medicare, or enters into contracts that 
fail to meet the specifications of Sec. 405.415; or
    (3) He or she fails to comply with the provisions of Sec. 405.440 
regarding billing for emergency care services or urgent care services; 
or
    (4) He or she fails to retain a copy of each private contract that 
he or she has entered into for the duration of the opt-out period for 
which the contracts are applicable or fails to permit HCFA to inspect 
them upon request.
    (b) If a physician or practitioner fails to maintain opt-out in 
accordance with paragraph (a) of this section, and fails to demonstrate, 
within 45 days of a notice from the carrier of a violation of paragraph 
(a) of this section, that he or she has taken good faith efforts to 
maintain opt-out (including by refunding amounts in excess of the charge 
limits to beneficiaries with whom he or she did not sign a private 
contract), the following results obtain, effective 46 days after the 
date of the notice, but only for the remainder of the opt-out period:
    (1) All of the private contracts between the physician or 
practitioner and Medicare beneficiaries are deemed null and void.
    (2) The physician's or practitioner's opt-out of Medicare is 
nullified.
    (3) The physician or practitioner must submit claims to Medicare for 
all Medicare-covered items and services furnished to Medicare 
beneficiaries.
    (4) The physician or practitioner or beneficiary will not receive 
Medicare payment on Medicare claims for the remainder of the opt-out 
period, except as provided in paragraph (c) of this section.
    (5) The physician is subject to the limiting charge provisions of 
Sec. 414.48 of this chapter.
    (6) The practitioner may not reassign any claim except as provided 
in Sec. 424.80 of this chapter.
    (7) The practitioner may neither bill nor collect any amount from 
the beneficiary except for applicable deductible and coinsurance 
amounts.
    (8) The physician or practitioner may not attempt to once more meet 
the criteria for properly opting-out until the 2-year opt-out period 
expires.
    (c) Medicare payment may be made for the claims submitted by a 
beneficiary for the services of an opt-out physician or practitioner 
when the physician or practitioner did not privately contract with the 
beneficiary for services that were not emergency care services or urgent 
care services and that were furnished no later than 15 days after the 
date of a notice by the carrier that the physician or practitioner has 
opted-out of Medicare.



Sec. 405.440  Emergency and urgent care services.

    (a) A physician or practitioner who has opted-out of Medicare under 
this subpart need not enter into a private contract to furnish emergency 
care services or urgent care services to a Medicare beneficiary. 
Accordingly, a physician or practitioner will not be determined to have 
failed to maintain opt-out if he or she furnishes emergency care 
services or urgent care services to a Medicare beneficiary with whom the 
physician or practitioner has not previously entered into a private 
contract, provided the physician or practitioner complies with the 
billing requirements specified in paragraph (b) of this section.
    (b) When a physician or practitioner who has not been excluded under 
sections 1128, 1156, or 1892 of the Social Security Act furnishes 
emergency care services or urgent care services to a Medicare 
beneficiary with whom the physician or practitioner has not previously 
entered into a private contract, he or she:
    (1) Must submit a claim to Medicare in accordance with both 42 CFR 
part 424 and Medicare instructions (including but not limited to 
complying with proper coding of emergency or urgent care services 
furnished by physicians

[[Page 81]]

and practitioners who have opted-out of Medicare).
    (2) May collect no more than--
    (i) The Medicare limiting charge, in the case of a physician; or
    (ii) The deductible and coinsurance, in the case of a practitioner.
    (c) Emergency care services or urgent care services furnished to a 
Medicare beneficiary with whom the physician or practitioner has 
previously entered into a private contract (that is, entered into before 
the onset of the emergency medical condition or urgent medical 
condition), are furnished under the terms of the private contract.
    (d) Medicare may make payment for emergency care services or urgent 
care services furnished by a physician or practitioner who has properly 
opted-out when the services are furnished and the claim for services is 
made in accordance with this section. A physician or practitioner who 
has been excluded must comply with the regulations at Sec. 1001.1901 
(Scope and effect of exclusion) of this title when he or she furnishes 
emergency services to beneficiaries and may not bill and be paid for 
urgent care services.



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

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



Sec. 405.450  Appeals.

    (a) A determination by HCFA that a physician or practitioner has 
failed to properly opt-out, failed to maintain opt-out, failed to timely 
renew opt-out, failed to privately contract, or failed to properly 
terminate opt-out is an initial determination for purposes of 
Sec. 405.803.
    (b) A determination by HCFA that no payment can be made to a 
beneficiary for the services of a physician who has opted-out is an 
initial determination for purposes of Sec. 405.803.



Sec. 405.455  Application to Medicare+Choice contracts.

    An organization that has a contract with HCFA to provide one or more 
Medicare+Choice (M+C) plans to beneficiaries (part 422 of this chapter):
    (a) Must acquire and maintain information from Medicare carriers on 
physicians and practitioners who have opted-out of Medicare.
    (b) Must make no payment directly or indirectly for Medicare covered 
services furnished to a Medicare beneficiary by a physician or 
practitioner who has opted-out of Medicare.

[[Page 82]]

    (c) May make payment to a physician or practitioner who furnishes 
emergency or urgent care services to a beneficiary who has not 
previously entered into a private contract with the physician or 
practitioner in accordance with Sec. 405.440.



         Subpart E--Criteria for Determining Reasonable Charges

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

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



Sec. 405.500  Basis.

    Subpart E is based on the provisions of the following sections of 
the Act: Section 1814(b) provides for Part A payment on the basis of the 
lesser of a provider's reasonable costs or customary charges. Section 
1832 establishes the scope of benefits provided under the Part B 
supplementary medical insurance program. Section 1833(a) sets forth the 
amounts of payment for supplementary medical insurance services on the 
basis of the lesser of a provider's reasonable costs or customary 
charges. Section 1834(a) specifies how payments are made for the 
purchase or rental of new and used durable medical equipment for 
Medicare beneficiaries. Section 1834(b) provides for payment for 
radiologist services on a fee schedule basis. Section 1834(c) provides 
for payments and standards for screening mammography. Section 1842(b) 
sets forth the provisions for a carrier to enter into a contract with 
the Secretary and to make determinations with respect to Part B claims. 
Section 1842(h) sets forth the requirements for a physician or supplier 
to voluntarily enter into an agreement with the Secretary to become a 
participating physician or supplier. Section 1842(i) sets forth the 
provisions for the payment of Part B claims. Section 1848 establishes a 
fee schedule for payment of physician services. Section 1861(b) sets 
forth the inpatient hospital services covered by the Medicare program. 
Section 1861(s) sets forth medical and other health services covered by 
the Medicare program. Section 1861(v) sets forth the general authority 
under which HCFA may establish limits on provider costs recognized as 
reasonable in determining Medicare program payments. Section 1861(aa) 
sets forth the rural health clinic services and Federally qualified 
health center services covered by the Medicare program. Section 1861(jj) 
defines the term ``covered osteoporosis drug.'' Section 1862(a)(14) 
lists services that are excluded from coverage. Section 1866(a) 
specifies the terms for provider agreements. Section 1881 authorizes 
special rules for the coverage of and payment for services furnished to 
patients with end-stage renal disease. Section 1886 sets forth the 
requirements for payment to hospitals for inpatient hospital services. 
Section 1887 sets forth requirements for payment of provider-based 
physicians and payment under certain percentage arrangements. Section 
1889 provides for Medicare and Medigap information by telephone.

[60 FR 63175, Dec. 8, 1995]



Sec. 405.501  Determination of reasonable charges.

    (a) Except as specified in paragraphs (b), (c), and (d) of this 
section, Medicare pays no more for Part B medical and other health 
services than the ``reasonable charge'' for such service. The reasonable 
charge is determined by the carriers (subject to any deductible and 
coinsurance amounts as specified in Secs. 410.152 and 410.160 of this 
chapter).
    (b) Part B of Medicare pays on the basis of ``reasonable cost'' (see 
part 413 of this chapter) for certain institutional services, certain 
services furnished under arrangements with institutions, and services 
furnished by entities that elect to be paid on a cost basis (including 
health maintenance organizations, rural health clinics, Federally 
qualified health centers and end-stage renal disease facilities).
    (c) Carriers will determine the reasonable charge on the basis of 
the criteria specified in Sec. 405.502, and the customary and prevailing 
charge screens in effect when the service was furnished. (Also see 
Secs. 415.55 through 415.70 and Secs. 415.100 through 415.130 of this 
chapter, which pertain to the determination of reimbursement for 
services

[[Page 83]]

performed by hospital-based physicians.) However, when services are 
furnished more than 12 months before the beginning of the fee screen 
year (January 1 through December 30) in which a request for payment is 
made, payment is based on the customary and prevailing charge screens in 
effect for the fee screen year that ends immediately preceding the fee 
screen year in which the claim or request for payment is made.
    (d) Payment under Medicare Part B for durable medical equipment and 
prosthetic and orthotic devices is determined in accordance with the 
provisions of subpart D of part 414 of this chapter.

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



Sec. 405.502  Criteria for determining reasonable charges.

    (a) Criteria. The law allows for flexibility in the determination of 
reasonable charges to accommodate reimbursement to the various ways in 
which health services are furnished and charged for. The criteria for 
determining what charges are reasonable include:
    (1) The customary charges for similar services generally made by the 
physician or other person furnishing such services.
    (2) The prevailing charges in the locality for similar services.
    (3) In the case of physicians' services, the prevailing charges 
adjusted to reflect economic changes as provided under Sec. 405.504 of 
this subpart.
    (4) In the case of medical services, supplies, and equipment that 
are reimbursed on a reasonable charge basis (excluding physicians' 
services), the inflation-indexed charge as determined under 
Sec. 405.509.
    (5) [Reserved]
    (6) In the case of medical services, supplies, and equipment 
(including equipment servicing) that the Secretary judges do not 
generally vary significantly in quality from one supplier to another, 
the lowest charge levels at which such services, supplies, and equipment 
are widely and consistently available in a locality.
    (7) Other factors that may be found necessary and appropriate with 
respect to a category of service to use in judging whether the charge is 
inherently reasonable. This includes special reasonable charge limits 
(which may be either upper or lower limits) established by HCFA or a 
carrier if it determines that the standard rules for calculating 
reasonable charges set forth in this subpart result in the grossly 
deficient or excessive charges. The determination of these limits is 
described in paragraphs (g) and (h) of this section.
    (8) In the case of laboratory services billed by a physician but 
performed by an outside laboratory, the payment levels established in 
accordance with the criteria stated in Sec. 405.515.
    (9) Except as provided in paragraph (a)(10) of this section, in the 
case of services of assistants-at-surgery as defined in Sec. 405.580 in 
teaching and non-teaching settings, charges that are not more than 16 
percent of the prevailing charge in the locality, adjusted by the 
economic index, for the surgical procedure performed by the primary 
surgeon. Payment is prohibited for the services of an assistant-at-
surgery in surgical procedures for which HCFA has determined that 
assistants-at-surgery on average are used in less than 5 percent of such 
procedures nationally.
    (10) In the case of services of assistants at surgery that meet the 
exception under Sec. 415.190(c)(2) or (c)(3) of this chapter because the 
physician is performing a unique, necessary, specialized medical service 
in the total care of a patient during surgery, reasonable charges 
consistent with prevailing practice in the carrier's service area rather 
than the special assistant at surgery rate.
    (b) Comparable services limitation. The law also specifies that the 
reasonable charge cannot be higher than the charge applicable for a 
comparable service under comparable circumstances to the carriers' own 
policyholders and subscribers.
    (c) Application of criteria. In applying these criteria, the 
carriers are to exercise judgment based on factual data on the charges 
made by physicians to patients generally and by other persons

[[Page 84]]

to the public in general and on special factors that may exist in 
individual cases so that determinations of reasonable charge are 
realistic and equitable.
    (d) Responsibility of Administration and carriers. Determinations by 
carriers of reasonable charge are not reviewed on a case-by-case basis 
by the Health Care Financing Administration, although the general 
procedures and performance of functions by carriers are evaluated. In 
making determinations, carriers apply the provisions of the law under 
broad principles issued by the Health Care Financing Administration. 
These principles are intended to assure overall consistency among 
carriers in their determinations of reasonable charge. The principles in 
Secs. 405.503 through 405.507 establish the criteria for making such 
determinations in accordance with the statutory provisions.
    (e) Determination of reasonable charges under the End-Stage Renal 
Disease (ESRD) Program--(1) General. Reasonable charges for renal-
related items and services (furnished in connection with transplantation 
or dialysis) must be related to costs and allowances that are reasonable 
when the treatments are furnished in an effective and economical manner.
    (2) Nonprovider (independent) dialysis facilities. Reasonable 
charges for renal-related items and services furnished before August 1, 
1983 must be determined related to costs and charges prior to July, 
1973, in accordance with the regulations at Sec. 405.541. Items and 
services related to outpatient maintenance dialysis that are furnished 
after that date are paid for in accordance with Secs. 405.544 and 
413.170 of this chapter.
    (3) Provider services and (hospital-based) dialysis facilities. 
Renal-related items and services furnished by providers, or by ESRD 
facilities based in hospitals, before August 1, 1983 are paid for under 
the provider reimbursement provisions found generally in part 413 of 
this chapter. Items and services related to outpatient maintenance 
dialysis that are furnished after that date are paid for in accordance 
with Secs. 405.544 and 413.170 of this chapter.
    (4) Physicians' services. Reasonable charges for renal-related 
physicians' services must be determined considering charges made for 
other services involving comparable physicians' time and skill 
requirements, in accordance with regulations at Secs. 405.542 and 
405.543.
    (5) Health maintenance organizations (HMOs). For special rules 
concerning the reimbursement of ESRD services furnished by risk-basis 
HMOs, or by facilities owned or operated by or related to such HMOs by 
common ownership or control, see Secs. 405.2042(b)(14) and 405.2050(c).
    (f) Determining payments for certain physician services furnished in 
outpatient hospital settings--(1) General rule. If physician services of 
the type routinely furnished in physicians' offices are furnished in 
outpatient hospital settings before January 1, 1992, carriers determine 
the reasonable charge for those services by applying the limits 
described in paragraph (f)(5) of this section.
    (2) Definition. As used in this paragraph (f), outpatient settings 
means--
    (i) Hospital outpatient departments, including clinics and emergency 
rooms; and
    (ii) Comprehensive outpatient rehabilitation facilities.
    (3) Services covered by limits. The carrier establishes a list of 
services routinely furnished in physicians' offices in the area. The 
carrier has the discretion to determine which professional services are 
routinely furnished in physicians' offices, based on current medical 
practice in the area. Listed below are some examples of routine services 
furnished by office-based physicians.

                                Examples

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

    (4) Services excluded from limits. The limits established under this 
paragraph do not apply to the following:
    (i) Rural health clinic services.
    (ii) Surgical services included on the ambulatory surgical center 
list of procedures published under Sec. 416.65(c) of this chapter.

[[Page 85]]

    (iii) Services furnished in a hospital emergency room after the 
sudden onset of a medical condition manifesting itself by acute symptoms 
of sufficient severity (including severe pain) such that the absence of 
immediate medical attention could reasonably be expected to result in--
    (A) Placing the patient's health in serious jeopardy;
    (B) Serious impairment to bodily functions; or
    (C) Serious dysfunction of any bodily organ or part.
    (iv) Anesthesiology services and diagnostic and therapeutic 
radiology services.
    (v) Federally qualified health center services paid under the rules 
in part 405 subpart X.
    (5) Methodology for developing limits--(i) Development of a charge 
base. The carrier establishes a charge base for each service identified 
as a routine office-based physician service. The charge base consists of 
the prevailing charge in the locality for each such service adjusted by 
the economic index. The carrier uses the prevailing charges that apply 
to services by nonspecialists in office practices in the locality in 
which the outpatient setting is located.
    (ii) Calculation of the outpatient limits. The carrier calculates 
the charge limit for each service by multiplying the charge base amount 
for each service by .60.
    (6) Application of limits. The reasonable charge for physician 
services of the type described in paragraph (f)(3) of this section that 
are furnished in an outpatient setting is the lowest of the actual 
charges, the customary charges in accordance with Sec. 405.503, the 
prevailing charges applicable to these services in accordance with 
Sec. 405.504, or the charge limits calculated in paragraph (f)(5)(ii) of 
this section.
    (g) Determination of payment amounts in special circumstances--(1) 
General. (i) For purposes of this paragraph, a ``category of items or 
services'' may consist of a single item or service or any number of 
items or services.
    (ii) HCFA or a carrier may determine that the standard rules for 
calculating Part B payment amounts for a category of items or services 
identified in section 1861(s) of the Act (other than physician services 
paid under section 1848 of the Act) will result in grossly deficient or 
excessive amounts.
    (iii) If HCFA or the carrier determines that the standard rules for 
calculating payment amounts for a category of items or services set 
forth in this subpart will result in grossly deficient or excessive 
amounts, HCFA or the carrier may establish special payment limits that 
are realistic and equitable for a category of items or services.
    (iv) The limit on the payment amount is either an upper limit to 
correct a grossly excessive payment amount or a lower limit to correct a 
grossly deficient payment amount.
    (v) The limit is either a specific dollar amount or is based on a 
special method to be used in determining the payment amount.
    (vi) Except as provided in paragraph (h) of this section, a payment 
limit for a given year may not vary by more than 15 percent from the 
payment amount established for the preceding year.
    (vii) Examples of excessive or deficient payment amounts. Examples 
of the factors that may result in grossly deficient or excessive payment 
amounts include, but are not limited to, the following:
    (A) The marketplace is not competitive. This includes circumstances 
in which the marketplace for a category of items or services is not 
truly competitive because a limited number of suppliers furnish the item 
or service.
    (B) Medicare and Medicaid are the sole or primary sources of payment 
for a category of items or services.
    (C) The payment amounts for a category of items or services do not 
reflect changing technology, increased facility with that technology, or 
changes in acquisition, production, or supplier costs.
    (D) The payment amounts for a category of items or services in a 
particular locality are grossly higher or lower than payment amounts in 
other comparable localities for the category of items or services, 
taking into account the relative costs of furnishing the category of 
items or services in the different localities.

[[Page 86]]

    (E) Payment amounts for a category of items or services are grossly 
higher or lower than acquisition or production costs for the category of 
items or services.
    (F) There have been increases in payment amounts for a category of 
items or services that cannot be explained by inflation or technology.
    (G) The payment amounts for a category of items or services are 
grossly higher or lower than the payments made for the same category of 
items or services by other purchasers in the same locality.
    (2) Establishing a limit. In establishing a payment limit for a 
category of items or services, HCFA or a carrier considers the available 
information that is relevant to the category of items or services and 
establishes a payment amount that is realistic and equitable. The 
factors HCFA or a carrier consider in establishing a specific dollar 
amount or special payment method for a category of items or services may 
include, but are not limited to, the following:
    (i) Price markup. This is the relationship between the retail and 
wholesale prices or manufacturer's costs of a category of items or 
services. If information on a particular category of items or services 
is not available, HCFA or a carrier may consider the markup on a similar 
category of items or services and information on general industry 
pricing trends.
    (ii) Differences in charges. HCFA or a carrier may consider the 
differences in charges for a category of items or services made to non-
Medicare and Medicare patients or to institutions and other large volume 
purchasers.
    (iii) Costs. HCFA or a carrier may consider resources (for example, 
overhead, time, acquisition costs, production costs, and complexity) 
required to produce a category of items or services.
    (iv) Utilization. HCFA or a carrier may impute a reasonable rate of 
use for a category of items or services and consider unit costs based on 
efficient utilization.
    (v) Payment amounts in other localities. HCFA or a carrier may 
consider payment amounts for a category of items or services furnished 
in another locality.
    (3) Notification of limits--(i) National limits. HCFA publishes in 
the Federal Register proposed and final notices announcing a special 
payment limit described in this paragraph (g) before it adopts the 
limit. The notices set forth the criteria and circumstances, if any, 
under which a carrier may grant an exception to a payment limit for a 
category of items or services.
    (ii) Carrier-level limits. A carrier proposing to establish a 
special payment limit for a category of items or services must inform 
the affected suppliers and State Medicaid agencies of the factors it 
considered in determining and in establishing the limit, as described in 
paragraphs (g)(1) through (g)(3) of this section, and solicit comments. 
The carrier must evaluate the comments it receives and inform the 
affected suppliers, State Medicaid agencies, and HCFA of any final 
limits it establishes. HCFA acknowledges in writing to the carrier that 
it received the carrier's notification. After the carrier has received 
HCFA's acknowledgement, the limit may be effective for services 
furnished at least 30 days after the date of the carrier's notification.
    (h) Special payment limit adjustments greater than 15 percent of the 
payment amount. In addition to applying the general rules under 
paragraphs (g)(1) through (g)(3) of this section, HCFA applies the 
following rules in determining and establishing a payment adjustment 
greater than 15 percent of the payment amount for a category of items or 
services within a year:
    (1) Potential impact of special limit. HCFA considers the potential 
impact on quality, access, beneficiary liability, assignment rates, and 
participation of suppliers.
    (2) Supplier consultation. Before making a determination that a 
payment amount for a category of items or services is not inherently 
reasonable by reason of its grossly excessive or deficient amount, HCFA 
consults with representatives of the suppliers likely to be affected by 
the change in the payment amount.
    (3) Publication of national limits. If HCFA determines under this 
paragraph (h) to establish a special payment limit for a category of 
items or services, it publishes in the Federal Register

[[Page 87]]

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

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

[32 FR 12599, Aug. 31, 1967]

    Editorial Note: For Federal Register citations affecting 
Sec. 405.502, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 405.503  Determining customary charges.

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

[[Page 88]]

person's ``customary'' charge. Use of relative value scales will help in 
arriving at a decision in such instances.
    (c) Use of relative value scales. If, for a particular medical 
procedure or service, the carrier is unable to determine the customary 
charge on the basis of reliable statistical data (for example, because 
the carrier does not yet have sufficient data or because the performance 
of the particular medical procedure or service by the physician or other 
person is infrequent), the carrier may use appropriate relative value 
scales to determine the customary charge for such procedure or service 
in relation to customary charges of the same physician or person for 
other medical procedures and services.
    (d) Revision of customary charge. A physician's or other person's 
customary charge is not necessarily a static amount. Where a physician 
or other person alters his charges, a revised pattern of charges for his 
services may develop. Where on the basis of adequate evidence, the 
carrier finds that the physician or other person furnishing services has 
changed his charge for a service to the public in general, the customary 
charge resulting from the revised charge for the service should be 
recognized as the customary charge in making determinations of 
reasonable charges for such service when rendered thereafter to 
supplementary insurance beneficiaries. If the new customary charge is 
not above the top of the range of prevailing charges (see 
Sec. 405.504(a)), it should be deemed to be reasonable by the carrier, 
subject to the provisions of Sec. 405.508.



Sec. 405.504  Determining prevailing charges.

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

[[Page 89]]

shown in data on self-employed physicians' gross incomes.

    Example. The available data indicate the office-expense and earnings 
components of the index should be given relative weights of 40 percent 
and 60 percent, respectively, and it is calculated that the aggregate 
increase in expenses of practice for a particular July through June 
period was 112 percent over the expenses of practice for calendar year 
1971 and the increase in earnings (less increases in workers' 
productivity was 110 percent over the earnings for calendar year 1971. 
The allowable increase in any prevailing charge that could be recognized 
during the next fee screen year would be 110.8 percent 
((.40 x 112)+(.60) x 110)=110.8) above the prevailing charge recognized 
for fiscal year 1973.

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

[[Page 90]]

development of more than one range of prevailing charges for application 
by the carrier in its determinations of reasonable charges. Carrier 
decisions in this respect should be responsive to the existing patterns 
of charges by physicians and other persons who render covered services, 
and should establish differentials in the levels of charges between 
different kinds of practice or service only where in accord with such 
patterns.
    (c) Re-evaluation and adjustment of prevailing charges. 
Determinations of prevailing charges by the carrier are to be re-
evaluated and adjusted from time to time on the basis of factual 
information about the charges made by physicians and other persons to 
the public in general. This information should be obtained from all 
possible sources including a carrier's experience with its own programs 
as well as with the supplementary medical insurance program.
    (d) Computation and issuance of the MEI after CY 1992--(1) For 
update years after CY 1992, the MEI is a physician input price index, in 
which the annual percent changes for the direct-labor price components 
are adjusted by an annual percent change in a 10-year moving average 
index of labor productivity in the nonfarm business sector.
    (2) The MEI is constructed, using as a base year, CY 1989 weights 
and annual percent changes in the economic price proxies as shown on the 
following chart:

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

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

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

[[Page 91]]



Sec. 405.505  Determination of locality.

    ``Locality'' is the geographical area for which the carrier is to 
derive the reasonable charges or fee schedule amounts for services or 
items. Usually, a locality may be a State (including the District of 
Columbia, a territory, or a Commonwealth), a political or economic 
subdivision of a State, or a group of States. It should include a cross 
section of the population with respect to economic and other 
characteristics. Where people tend to gravitate toward certain 
population centers to obtain medical care or service, localities may be 
recognized on a basis constituting medical services areas (interstate or 
otherwise), comparable in concept to ``trade areas.'' Localities may 
differ in population density, economic level, and other major factors 
affecting charges for services. Carriers therefore shall delineate 
localities on the basis of their knowledge of local conditions. However, 
distinctions between localities are not to be so finely made that a 
locality includes only a very limited geographic area whose population 
has distinctly similar income characteristics (e.g., a very rich or very 
poor neighborhood within a city).

[57 FR 27305, June 18, 1992]



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

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

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

[43 FR 32300, July 26, 1978]



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

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

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



Sec. 405.508  Determination of comparable circumstances; limitation.

    (a) Application of limitation. The carrier may not in any case make 
a determination of reasonable charge which would be higher than the 
charge upon which it would base payment to its own policyholders for a 
comparable

[[Page 92]]

service in comparable circumstances. The charge upon which it would base 
payment, however, does not necessarily mean the amount the carrier would 
be obligated to pay. Under certain circumstances, some carriers pay 
amounts on behalf of individuals who are their policyholders, which are 
below the customary charges of physicians or other persons to other 
individuals. Payment under the supplementary medical insurance program 
would not be limited to these lower amounts.
    (b) When comparability exists. ``Comparable circumstances,'' as used 
in the Act and this subpart, refers to the circumstances under which 
services are rendered to individuals and the nature of the carrier's 
health insurance programs and the method it uses to determine the 
amounts of payments under these programs. Generally, comparability would 
exist where:
    (1) The carrier bases payment under its program on the customary 
charges, as presently constituted, of physicians or other persons and on 
current prevailing charges in a locality, and
    (2) The determination does not preclude recognition of factors such 
as speciality status and unusual circumstances which affect the amount 
charged for a service.
    (c) Responsibility for determining comparability. Responsibility for 
determining whether or not a carrier's program has comparability will in 
the first instance fall upon the carrier in reporting pertinent 
information about its programs to the Health Care Financing 
Administration. When the pertinent information has been reported, the 
Health Care Financing Administration will advise the carrier whether any 
of its programs have comparability.



Sec. 405.509  Determining the inflation-indexed charge.

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

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



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

    (a) General rule. (1) A charge for any medical service, supply, or 
equipment (including equipment servicing) that in the judgment of HCFA 
generally does not vary significantly in quality from one supplier to 
another (and that is identified by a notice published in the Federal 
Register) may not be considered reasonable if it exceeds:
    (i) The customary charge of the supplier (see Sec. 405.503);
    (ii) The prevailing charge in the locality (see Sec. 405.504);
    (iii) The charge applicable for a comparable service and under 
comparable circumstances to the policyholders or subscribers of the 
carrier (see Sec. 405.508);

[[Page 93]]

    (iv) The lowest charge level at which the item or service is widely 
and consistently available in the locality (see paragraph (c) of this 
section); or
    (v) The inflation-indexed charge, as determined under Sec. 405.509, 
in the case of medical services, supplies, and equipment that are 
reimbursed on a reasonable charge basis (excluding physicians' 
services).
    (2) In the case of laboratory services, paragraph (a)(1) of this 
section is applicable to services furnished by physicians in their 
offices, by independent laboratories (see Sec. 405.1310(a)) and to 
services furnished by a hospital laboratory for individuals who are 
neither inpatients nor outpatients of a hospital. Allowance of 
additional charges exceeding the lowest charge level can be approved by 
the carrier on the basis of unusual circumstances or medical 
complications in accordance with Sec. 405.506.
    (b) Public notice of items and services subject to the lowest charge 
level rule. Before the Secretary determines that lowest charge levels 
should be established for an item or service, notice of the proposed 
determination will be published with an opportunity for public comment. 
The descriptions or specifications of items or services in the notice 
will be in sufficient detail to permit a determination that items or 
services conforming to the descriptions will not vary significantly in 
quality.
    (c) Calculating the lowest charge level. The lowest charge level at 
which an item or service is widely and consistently available in a 
locality is calculated by the carrier in accordance with instructions 
from HCFA as follows:
    (1) For items or services furnished on or before December 31, 1986.
    (i) A lowest charge level is calculated for each identified item or 
service in January and July of each year.
    (ii) The lowest charge level for each identified item or service is 
set at the 25th percentile of the charges (incurred or submitted on 
claims processed by the carrier) for that item or service, in the 
locality designated by the carrier for this purpose, during the second 
calendar quarter preceding the determination date. Accordingly, the 
January calculations will be based on charges for the July through 
September quarter of the previous calendar year, and the July 
calculations will be based on charges for the January through March 
quarter of the same calendar year.
    (2) For items or services furnished on or after January 1, 1987.
    (i) A lowest charge level is calculated for each identified item or 
service in January of each year.
    (ii) The lowest charge level for each identified item or service is 
set at the 25th percentile of the charges (incurred or submitted on 
claims processed by the carrier) for that item or service, in the 
locality designated by the carrier for this purpose, during the 3-month 
period of July 1 through September 30 preceding the fee screen year 
(January 1 through December 31) for which the item or service was 
furnished.
    (3) Lowest charge levels for laboratory services. In setting lowest 
charge levels for laboratory services, the carrier will consider only 
charges made for laboratory services performed by physicians in their 
offices, by independent laboratories which meet coverage requirements, 
and for services furnished by a hospital laboratory for individuals who 
are neither inpatients nor outpatients of a hospital.
    (d) Locality. Subject to the approval of the Secretary, the carrier 
may designate its entire service area as the locality for purposes of 
this section, or may otherwise modify the localities used for 
calculating prevailing charges. (The modified locality for an item or 
service will also be used for calculating the prevailing charge for that 
item or service.)

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

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



Sec. 405.512  Carriers' procedural terminology and coding systems.

    (a) General. Procedural terminology and coding systems are designed 
to provide physicians and third party payers with a common language that 
accurately describes the kinds and levels of services provided and that 
can serve as a basis for coverage and payment determinations.

[[Page 94]]

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

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



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

    This section implements section 1842(h) of the Social Security Act, 
which places a limitation on reimbursement for markups on clinical 
laboratory services billed by physicians. If a physician's bill, or a 
request for payment for a physician's services, includes a charge for a 
laboratory test for which payment may be made under this part, the 
amount payable with respect to the test shall be determined as follows 
(subject to the coinsurance and deductible provisions at Secs. 410.152 
and 410.160 of this chapter):
    (a) If the bill or request for payment indicates that the test was 
personally performed or supervised either by the physician who submitted 
the bill (or for whose services the request for payment was made), or by 
another physician with whom that physician shares his or her practice, 
the payment will be based on the physician's reasonable charge for the 
test (as determined in accordance with Sec. 405.502).
    (b) If the bill or request for payment indicates that the test was 
performed by an outside laboratory, and identifies both the laboratory 
and the amount the laboratory charged, payment for the test will be 
based on the lower of--

[[Page 95]]

    (1) The laboratory's reasonable charge for the service (as 
determined in accordance with Sec. 405.502), or
    (2) The amount that the laboratory charged the physician for the 
service.
    (c) If the bill or request for payment does not indicate that the 
conditions specified in paragraph (a) of this section were met, and does 
not identify both the laboratory and the amount the laboratory charged, 
payment will be based on the lowest charge at which the carrier 
estimates the test could have been secured from a laboratory serving the 
physician's locality. The carrier will estimate this lowest amount twice 
a year by (i) obtaining lists of charges laboratories make to physicians 
from as many commercial laboratories serving the carrier's area as 
possible (including laboratories in other States from which tests may be 
obtained by physicians in the carrier's service area) and (ii) 
establishing a schedule of lowest prices based on this information. The 
carrier will take into consideration specific circumstances, such as a 
need for emergency services that may be costlier than routine services, 
in making the estimate in a particular case. However, in no case may 
this estimate be higher than the lowest customary charge for commercial 
laboratories, or when applicable to the laboratory service, the lowest 
charge level determined in accordance with Sec. 405.511, in the 
carrier's service area.
    (d) When a physician bills, in accordance with paragraph (b) or (c) 
of this section, for a laboratory test and indicates that it was 
performed by an independent laboratory, a nominal payment will also be 
made to the physician for collecting, handling, and shipping the 
specimen to the laboratory, if the physician bills for such a service.

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



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

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

[63 FR 58905, Nov. 2, 1998]



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

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

[[Page 96]]

and deductible is subject to a civil money penalty not to exceed $2,000 
for each bill or request for payment.

[63 FR 58905, Nov. 2, 1998]



Sec. 405.534  Limitation on payment for screening mammography services.

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

[55 FR 53521, Dec. 31, 1990, as amended at 59 FR 49833, Sept. 30, 1994]



Sec. 405.535  Special rules for nonparticipating physicians and suppliers furnishing screening mammography services.

    If screening mammography services are furnished to a beneficiary by 
a nonparticipating physician or supplier that does not accept 
assignment, a limiting charge applies to the charges billed to the 
beneficiary. The limiting charge is the lesser of the following:
    (a) 115 percent of the payment limit set forth in 
Sec. 405.534(b)(3), (c)(3), and (d)(3) (limitations on the global 
service, professional component, and technical component of screening 
mammography services, respectively).
    (b) The limiting charge for the global service, professional 
component, and technical component of a diagnostic bilateral mammogram 
under the fee schedule for physicians' services set forth at 
Sec. 414.48(b) of this chapter.

[59 FR 49833, Sept. 30, 1994, as amended at 62 FR 59098, Oct. 31, 1997]

Subpart F--[Reserved]



      Subpart G--Reconsiderations and Appeals Under Medicare Part A

    Authority: Secs. 1102, 1155, 1869(b), 1871, 1872, and 1879 of the 
Social Security Act (42

[[Page 97]]

U.S.C. 1302, 1320c-4, 1395ff(b), 1395hh, 1395ii, and 1395pp).

    Source: 37 FR 5814, Mar. 22, 1972, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.



Sec. 405.701  Basis, purpose and definitions.

    (a) This subpart implements section 1869 of the Social Security Act. 
Section 1869(a) provides that the Secretary will make determinations 
about the following matters, and section 1869(b) provides for a hearing 
for an individual who is dissatisfied with the Secretary's determination 
as to:
    (1) Whether the individual is entitled to hospital insurance (part 
A) or supplementary medical insurance (part B) under title XVIII of the 
Act; or
    (2) The amount payable under hospital insurance.
    (b) This subpart establishes the procedures governing initial 
determinations, reconsidered determinations, hearings, and final agency 
review, and the reopening of determinations and decisions that are 
applicable to matters arising under paragraph (a) of this section.
    (c) Subparts J and R of 20 CFR part 404 (dealing with 
determinations, the administrative review process and representation of 
parties) are also applicable to matters arising under paragraph (a) of 
this section, except to the extent that specific provisions are 
contained in this subpart.
    (d) Definitions. As used in subpart G of this part, the term--
    Appellant designates the beneficiary, provider or other person or 
entity that has filed an appeal concerning a particular determination of 
benefits under Medicare part A. Designation as an appellant does not in 
itself convey standing to appeal the determination in question.
    Common issues of law and fact, with respect to the aggregation of 
claims by two or more appellants to meet the minimum amount in 
controversy needed for a hearing, occurs when the claims sought to be 
aggregated are denied or reduced for similar reasons and arise from a 
similar fact pattern material to the reason the claims are denied.
    Delivery of similar or related services, with respect to the 
aggregation of claims by two or more provider appellants to meet the 
minimum amount in controversy needed for a hearing, means like or 
coordinated services or items provided to the same beneficiary by the 
appellants.

[55 FR 11020, Mar. 26, 1990, as amended at 59 FR 12181, Mar. 16, 1994]



Sec. 405.702  Notice of initial determination.

    After a request for payment under part A of title XVIII of the Act 
is filed with the intermediary by or on behalf of the individual who 
received inpatient hospital services, extended care services, or home 
health services, and the intermediary has ascertained whether the items 
and services furnished are covered under part A of title XVIII, and 
where appropriate, ascertained and made payment of amounts due or has 
ascertained that no payments were due, the individual will be notified 
in writing of the initial determination in his case. In addition, if the 
items or services furnished such individual are not covered under part A 
of title XVIII by reason of Sec. 411.15(g) or Sec. 411.15(k) and payment 
may not be made for such items or services under Sec. 411.400 only 
because the requirements of Sec. 411.400(a)(2) are not met, the provider 
of services which furnished such items or services will be notified in 
writing of the initial determination in such individual's case. These 
notices shall be mailed to the individual and the provider of services 
at their last known addresses and shall state in detail the basis for 
the determination. Such written notices shall also inform the individual 
and the provider of services of their right to reconsideration of the 
determination if they are dissatisfied with the determination.

[55 FR 11020, Mar. 26, 1990]



Sec. 405.704  Actions which are initial determinations.

    (a) Applications and entitlement of individuals. An initial 
determination with respect to an individual includes the following--

[[Page 98]]

    (1) A determination with respect to entitlement to hospital 
insurance or supplementary medical insurance;
    (2) A disallowance of an individual's application for entitlement to 
hospital or supplementary medical insurance, if the individual fails to 
submit evidence requested by SSA to support the application. (SSA will 
specify in the initial determination the conditions of entitlement that 
the applicant failed to establish by not submitting the requested 
evidence);
    (3) A denial of a request for withdrawal of an application for 
hospital or supplementary medical insurance;
    (4) A denial of a request for cancellation of a ``request for 
withdrawal''; and
    (5) A determination as to whether an individual, previously 
determined to be entitled to hospital or supplementary medical 
insurance, is no longer entitled to such benefits, including a 
determination based on nonpayment of premiums.
    (b) Requests for payment by or on behalf of individuals. An initial 
determination with respect to an individual includes any determination 
made on the basis of a request for payment by or on behalf of the 
individual under part A of Medicare, including a determination with 
respect to:
    (1) The coverage of items and services furnished;
    (2) The amount of an applicable deductible;
    (3) The application of the coinsurance feature;
    (4) The number of days of inpatient hospital benefits utilized 
during a spell of illness or for purposes of the inpatient psychiatric 
hospital 190-day lifetime maximum;
    (5) The number of days of the 60-day lifetime reserve utilized for 
inpatient hospital coverage;
    (6) The number of days of posthospital extended care benefits 
utilized;
    (7) The number of home health visits utilized;
    (8) The physician certification requirement;
    (9) The request for payment requirement;
    (10) The beginning and ending of a spell of illness, including a 
determination made under the presumptions established under 
Sec. 409.60(c)(2) of this chapter, as specified in Sec. 409.60(c)(4) of 
this chapter.
    (11) The medical necessity of services (See parts 466 and 473 of 
this chapter for provisions pertaining to initial and reconsidered 
determinations made by a PRO);
    (12) When services are excluded from coverage as custodial care 
(Sec. 411.15(g)) or as not reasonable and necessary (Sec. 411.15(k)), 
whether the individual or the provider of services who furnished the 
services, or both, knew or could reasonably have been expected to know 
that the services were excluded from coverage (see Sec. 411.402);
    (13) Any other issues having a present or potential effect on the 
amount of benefits to be paid under part A of Medicare, including a 
determination as to whether there has been an overpayment or 
underpayment of benefits paid under part A, and if so, the amount 
thereof; and
    (14) Whether a waiver of adjustment or recovery under sections 1870 
(b) and (c) of the Act is appropriate when an overpayment of hospital 
insurance benefits or supplementary medical insurance benefits 
(including a payment under section 1814(e) of the Act) has been made 
with respect to an individual.
    (c) Initial determination with respect to a provider of services. An 
initial determination with respect to a provider of services shall be a 
determination made on the basis of a request for payment filed by the 
provider under part A of Medicare on behalf of an individual who was 
furnished items or services by the provider, but only if the 
determination involves the following:
    (1) A finding by the intermediary that such items or services are 
not covered by reason of Sec. 411.15(g) or Sec. 411.15(k); and
    (2) A finding by the intermediary that either such individual or 
such provider of services, or both, knew or could reasonably have been 
expected to know that such items or services were excluded from coverage 
under the program.

[55 FR 11020, Mar. 26, 1990]

[[Page 99]]



Sec. 405.705  Actions which are not initial determinations.

    An initial determination under Part A of Medicare does not include 
determinations relating to:
    (a) The reasonable cost of items or services furnished under Part A 
of Medicare;
    (b) Whether an institution or agency meets the conditions for 
participation in the program;
    (c) Whether an individual is qualified for use of the expedited 
appeals process as provided in Sec. 405.718;
    (d) An action regarding compromise of a claim arising under the 
Medicare program, or termination or suspension of collection action on 
such a claim under the Federal Claims Collection Act of 1966 (31 U.S.C. 
3711). See 20 CFR 404.515 for overpayment claims against an individual, 
Sec. 405.376 for overpayment claims against a provider, physician or 
other supplier, and Sec. 408.110 for claims concerning unpaid Medicare 
premiums;
    (e) The transfer or discharge of residents of skilled nursing 
facilities in accordance with Sec. 483.12 of this chapter; or
    (f) The preadmission screening and annual resident review processes 
required by part 483 subparts C and E of this chapter.

[45 FR 73932, Nov. 7, 1980; 46 FR 24565, May 1, 1981, as amended at 52 
FR 22454, June 12, 1987; 52 FR 48123, Dec. 18, 1987; 57 FR 56504, Nov. 
30, 1992; 61 FR 63749, Dec. 2, 1996]



Sec. 405.706  Decisions of utilization review committees.

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

[48 FR 39831, Sept. 1, 1983]



Sec. 405.708  Effect of initial determination.

    (a) The initial determination under Sec. 405.704 (a) or (b) shall be 
binding upon the individual on whose behalf payment under part A has 
been requested or, if such individual is deceased, upon the 
representative of such individual's estate, unless it is reconsidered in 
accordance with Secs. 405.710 through 405.717 or revised in accordance 
with Sec. 405.750. Such individual (or the representative of such 
individual's estate if the individual is deceased) shall be the party to 
such initial determination.
    (b) The initial determination under Sec. 405.704(c) shall be binding 
upon the provider of services unless it is reconsidered in accordance 
with Secs. 405.710 through 405.717 or revised in accordance with 
Sec. 405.750. Such provider of services shall be the party to such 
initial determination.

[55 FR 11021, Mar. 26, 1990, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.710  Right to reconsideration.

    (a) An individual who is a party to an initial determination, as 
specified in Sec. 405.704 (a) and (b), (or if such individual is 
deceased, the representative of such individual's estate) and who is 
dissatisfied with the initial determination may request a 
reconsideration of such determination in accordance with Sec. 405.711 
regardless of the amount in controversy.
    (b) A provider of services who is a party to an initial 
determination (as specified in Sec. 405.704(c)) and who is dissatisfied 
with such initial determination may request a reconsideration of such 
determination in accordance with Sec. 405.711, regardless of the amount 
in

[[Page 100]]

controversy, but only if the individual on whose behalf the request for 
payment was made has indicated in writing that he does not intend to 
request reconsideration of the intermediary's initial determination on 
such request for payment, or if the intermediary has made a finding (see 
Sec. 405.704(c)) that such individual did not know or could not 
reasonably have been expected to know that the expenses incurred for the 
items or services for which such request for payment was made were not 
reimbursable by reason of Sec. 411.15(g) or Sec. 411.15(k).

[55 FR 11021, Mar. 26, 1990]



Sec. 405.711  Time and place of filing request for reconsideration.

    The request for reconsideration shall be made in writing and filed 
at an office of the SSA or the HCFA or, in the case of a qualified 
railroad retirement beneficiary (see 20 CFR 404.368) filed at an office 
of the Railroad Retirement Board, within 60 days after the date of 
receipt of notice of initial determination, unless such time is extended 
as provided in Sec. 405.712. A request for reconsideration which is 
filed with the intermediary which received the request for payment 
submitted on behalf of the individual is considered to have been filed 
with the HCFA as of the date it is filed with the intermediary. For 
purposes of this section, the date of receipt of notice of the initial 
determination shall be presumed to be 5 days after the date of such 
notice, unless there is a reasonable showing to the contrary.

[41 FR 47917, Nov. 1, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 62 FR 25855, May 12, 1997]



Sec. 405.712  Extension of time to request reconsideration.

    If a party to an initial determination desires to file a request for 
reconsideration after the time for filing such request in accordance 
with Sec. 405.711 has passed, such party may file a petition with the 
SSA or the HCFA or, in the case of a qualified railroad retirement 
beneficiary, with the Railroad Retirement Board, for an extension of 
time for the filing of such request. Such petition shall be in writing 
and shall state the reasons why the request for reconsideration was not 
filed within the required time. For good cause shown, the HCFA may 
extend the time for filing the request for reconsideration.

[37 FR 5814, Mar. 22, 1972. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 62 FR 25855, May 12, 1997]



Sec. 405.714  Withdrawal of request for reconsideration.

    A request for reconsideration may be withdrawn by the party to the 
initial determination who filed the request or by his representative 
provided that the withdrawal is made in writing and filed at an office 
of the SSA or the HCFA or, in the case of a qualified railroad 
retirement beneficiary, with the Railroad Retirement Board prior to the 
date of the mailing of the notice of reconsidered determination. A 
withdrawal filed with the intermediary which received the request for 
payment submitted on behalf of the individual is considered to have been 
filed with the HCFA as of the date it is filed with the intermediary.

[40 FR 1025, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 62 FR 25855, May 12, 1997]



Sec. 405.715  Reconsidered determination.

    (a) In reconsidering an initial determination, the HCFA shall review 
such initial determination, the evidence and findings upon which such 
determination was based, and any additional evidence submitted to the 
SSA or the HCFA or otherwise obtained by the intermediary or the HCFA; 
and shall make a determination affirming or revising, in whole or in 
part, such initial determination.
    (b) If the request for reconsideration is filed by an individual 
with respect to an initial determination specified in 
Sec. 405.704(b)(12), the provider of services who furnished the items or 
services shall, prior to the making of the reconsidered determination, 
be made a party thereto. If pursuant to Sec. 405.710(b) a request for 
reconsideration is filed by a provider of services with respect to an 
individual determination under Sec. 405.704(c), the individual who was 
furnished the items or services shall, prior

[[Page 101]]

to the making of the reconsidered determination, be made a party 
thereto.

[55 FR 11021, Mar. 26, 1990, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.716  Notice of reconsidered determination.

    Written notice of the reconsidered determination shall be mailed by 
the HCFA to the parties and their representatives at their last known 
addresses. Such notice shall state the specific reasons for the 
reconsidered determination and shall advise the parties of their right 
to a hearing if the amount in controversy is $100 or more, or, if 
appropriate, advise them of the requirements for use of the expedited 
appeals process (see Sec. 405.718).

[40 FR 53387, Nov. 18, 1975. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.717  Effect of a reconsidered determination.

    The reconsidered determination is binding upon all parties unless--
    (a) A request for a hearing is filed with SSA or HCFA within 60 days 
after the date of receipt of notice of the reconsidered determination by 
the parties (for purposes of this section, the date of receipt of notice 
of the reconsidered determination is presumed to be 5 days after the 
date of the notice, unless it is shown that the notice was received 
earlier or later); or
    (b) The reconsidered determination is revised in accordance with 
Sec. 405.750; or
    (c) The expedited appeals process is used in accordance with 
Sec. 405.718.

[62 FR 25852, May 12, 1997]



Sec. 405.718  Expedited appeals process.

    (a) Conditions for use of expedited appeals process (EAP). A party 
may use the EAP to request court review in place of an administrative 
law judge (ALJ) hearing or Departmental Appeals Board (DAB) review if 
the following conditions are met:
    (1) HCFA has made a reconsideration determination; an ALJ has made a 
hearing decision; or DAB review has been requested, but a final decision 
has not been issued.
    (2) The filing entity is a party referred to in Sec. 405.718(d).
    (3) The party has filed a request for an ALJ hearing in accordance 
with Sec. 405.722, or DAB review in accordance with 20 CFR 404.968.
    (4) The amount remaining in controversy is $1,000 or more.
    (5) If there is more than one party to the reconsideration 
determination or hearing decision, each party concurs, in writing, with 
the request for the EAP.
    (b) Content of the request for EAP. The request for the EAP:
    (1) Alleges that there are no material issues of fact in dispute; 
and
    (2) Asserts that the only factor precluding a decision favorable to 
the party is a statutory provision that is unconstitutional or a 
regulation, national coverage decision under section 1862(a)(1) of the 
Act, or HCFA Ruling that is invalid.
    (c) Place and time for requesting an EAP--(1) Place for filing 
request. The person must file a written request--
    (i) At an office of SSA or HCFA; or
    (ii) If the person is in the Philippines, at the Veterans 
Administration Regional Office or with an ALJ; or
    (iii) If the person is a qualified railroad retirement beneficiary, 
at an office of the Railroad Retirement Board.
    (2) Time of filing request. The party may file a request for the 
EAP--
    (i) If the party has requested a hearing, at any time prior to 
receipt of the notice of the ALJ's decision;
    (ii) Within 60 days after the date of receipt of notice of the ALJ's 
decision or dismissal, unless the time is extended in accordance with 
the standards set out in 20 CFR 404.925(c). For purposes of this 
section, the date of receipt of the notice is presumed to be 5 days 
after the date on the notice, unless it is shown that the notice was 
received later; or
    (iii) If the party has requested DAB review, at any time prior to 
receipt of notice of the Board's decision.
    (d) Parties to the EAP. The parties to the EAP are the persons who 
were parties to the reconsideration determination and, if appropriate, 
to the hearing.
    (e) Determination on request for EAP. (1) For EAP requests initiated 
at the ALJ level, an ALJ determines whether all conditions of paragraphs 
(a) and (b) of this section are met.

[[Page 102]]

    (2) If a hearing decision has been issued, the DAB determines 
whether all conditions of paragraphs (a) and (b) of this section are 
met.
    (f) ALJ or DAB certification for the EAP. If the party meets the 
requirements for the EAP, the ALJ or the DAB, as appropriate, certifies 
the case in writing stating that:
    (1) The facts involved in the claim are not in dispute;
    (2) Except as indicated in paragraph (f)(3) of this section, HCFA's 
interpretation of the law is not in dispute;
    (3) The sole issue(s) in dispute is the constitutionality of a 
statutory provision or the validity of a regulation, HCFA Ruling, or 
national coverage decision based on section 1862(a)(1) of the Act.
    (4) Except for the provision challenged, the right(s) of the party 
is established; and
    (5) The determination or decision made by the ALJ or DAB is final 
for purposes of seeking judicial review.
    (g) Effect of ALJ or DAB certification. (1) Following the issuance 
of the certification described in paragraph (f) of this section, the 
party waives completion of the remaining steps of the administrative 
appeals process.
    (2) The 60-day period for filing a civil suit in a Federal district 
court begins on the date of receipt of the ALJ or DAB certification.
    (h) Effect of a request for EAP that does not result in 
certification. If a request for the EAP does not meet all the conditions 
for use of the process, the ALJ or DAB so advises the party and treats 
the request as a request for hearing or DAB review, as appropriate.

[62 FR 25852, May 12, 1997]



Sec. 405.720  Hearing; right to hearing.

    A person has a right to a hearing regarding any initial 
determination made under Sec. 405.704 if:
    (a) Such initial determination has been reconsidered by the HCFA;
    (b) Such person was a party to the reconsidered determination;
    (c) Such person or his representative has filed a written request 
for a hearing in accordance with the procedure described in 
Sec. 405.722; and
    (d) The amount in controversy is $100 or more.

[40 FR 1025, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 62 FR 25855, May 12, 1997]



Sec. 405.722  Time and place of filing request for a hearing.

    The request for a hearing shall be made in writing and filed at an 
office of the SSA or the HCFA or with a ALJ, or, in the case of a 
qualified railroad retirement beneficiary, at an office of the Railroad 
Retirement Board. Such request must be filed within 60 days after the 
date of receipt of notice of the reconsidered determination by such 
individual, except where the time is extended as provided in 20 CFR 
404.933(c). For purposes of this section, the date of receipt of notice 
of the reconsidered determination shall be presumed to be 5 days after 
the date of such notice, unless there is a reasonable showing to the 
contrary.

[45 FR 73933, Nov. 7, 1980, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.724  Departmental Appeals Board (DAB) review.

    Regulations beginning at 20 CFR 404.967 regarding SSA Appeals 
Council Review are also applicable to DAB review of matters addressed by 
this subpart.

[62 FR 25852, May 12, 1997]



Sec. 405.730  Court review.

    (a) To the extent authorized by sections 1869, 1876(c)(5)(B), and 
1879(d) of the Act, a party to a Departmental Appeals Board (DAB) 
decision or an ALJ decision if the DAB does not review the ALJ decision, 
may obtain a court review if the amount remaining in controversy is 
$1,000 or more. A party may obtain court review by filing a civil action 
in a district court of the United States in accordance with the 
provisions of section 205(g) of the Act. The filing procedure is set 
forth at 20 CFR 422.210.
    (b) A party to a reconsidered determination or an ALJ hearing 
decision may obtain a court review if the amount in controversy is 
$1,000 or more, and he or she requests and meets

[[Page 103]]

the conditions for the expedited appeals process set forth in 
Sec. 405.718.

[62 FR 25852, May 12, 1997]



Sec. 405.732  Review of national coverage decisions (NCDs).

    (a) General. (1) HCFA makes NCDs either granting, limiting, or 
excluding Medicare coverage for a specific medical service, procedure or 
device. NCDs are made under section 1862(a)(1) of the Act or other 
applicable provisions of the Act. An NCD is binding on all Medicare 
carriers, fiscal intermediaries, PROs, HMOs, CMPs, and HCPPs when 
published in HCFA program manuals or the Federal Register.
    (2) Under section 1869(b)(3) of the Act, only NCDs made under 
section 1862(a)(1) of the Act are subject to the conditions of 
paragraphs (b) through (d) of this section.
    (b) Review by ALJ. (1) An ALJ may not disregard, set aside, or 
otherwise review an NCD.
    (2) An ALJ may review the facts of a particular case to determine 
whether an NCD applies to a specific claim for benefits and, if so, 
whether the NCD has been applied correctly to the claim.
    (c) Review by Court. (1) A court's review of an NCD is limited to 
whether the record is incomplete or otherwise lacks adequate information 
to support the validity of the decision, unless the case has been 
remanded to the Secretary to supplement the record regarding the NCD. 
The court may not invalidate an NCD except upon review of the 
supplemented record.
    (2) A Federal court may not hold unlawful or set aside an NCD 
because it was not issued in accordance with the notice and comment 
procedures of the Administrative Procedure Act (5 U.S.C. 553) or section 
1871(b) of the Act.
    (d) Remands--(1) Secretary's action. When a court remands an NCD 
matter to the Secretary because the record in support of the NCD is 
incomplete or otherwise lacks adequate information, the Secretary 
remands the case to HCFA in order to supplement the record.
    (2) Remand to HCFA. HCFA supplements the record with new or updated 
evidence, including additional information from other sources, and may 
issue a revised NCD.
    (3) Final Actions. (i) The proceedings to supplement the record are 
expedited.
    (ii) When HCFA does not issue a revised NCD, it returns the 
supplemented record to the court for review.
    (iii) When HCFA issues a revised NCD, it forwards the case to an ALJ 
who issues a new decision applying the revised NCD to the facts of the 
claim(s) under consideration. The ALJ's decision is subject to DAB 
review and, ultimately, judicial review.

[62 FR 25852, May 12, 1997]



Sec. 405.740  Principles for determining the amount in controversy.

    (a) Individual appellants. For the purpose of determining whether an 
individual appellant meets the minimum amount in controversy needed for 
a hearing ($100), the following rules apply:
    (1) The amount in controversy is computed as the actual amount 
charged the individual for the items and services in question, less any 
amount for which payment has been made by the intermediary and less any 
deductible and coinsurance amounts applicable in the particular case.
    (2) A single beneficiary may aggregate claims from two or more 
providers to meet the $100 hearing threshold and a single provider may 
aggregate claims for services provided to one or more beneficiaries to 
meet the $100 hearing threshold.
    (3) In either of the circumstances specified in paragraph (a)(2) of 
this section, two or more claims may be aggregated by an individual 
appellant only if the claims have previously been reconsidered and a 
request for hearing has been made within 60 days after receipt of the 
reconsideration determination(s).
    (4) When requesting a hearing, the appellant must specify in his or 
her appeal request the specific claims to be aggregated.
    (b) Two or more appellants. As specified below, under section 
1869(b)(2) of the Act, two or more appellants may aggregate their claims 
together to meet the minimum amount in controversy needed for a hearing 
($100).

[[Page 104]]

The right to aggregate under this statutory provision applies to claims 
for items and services furnished on or after January 1, 1987.
    (1) The aggregate amount in controversy is computed as the actual 
amount charged the individual(s) for the items and services in question, 
less any amount for which payment has been made by the intermediary and 
less any deductible and coinsurance amounts applicable in the particular 
case.
    (2) In determining the amount in controversy, two or more appellants 
may aggregate their claims together under the following circumstances:
    (i) Two or more beneficiaries may combine claims representing 
services from the same or different provider(s) if the claims involve 
common issues of law and fact;
    (ii) Two or more providers may combine their claims if the claims 
involve the delivery of similar or related services to the same 
beneficiary; or
    (iii) Two or more providers may combine their claims if the claims 
involve common issues of law and fact with respect to services furnished 
to two or more beneficiaries.
    (iv) In any of the circumstances specified in paragraphs (b)(2)(i) 
through (b)(2)(iii) of this section, the claims may be aggregated only 
if the claims have previously been reconsidered and a request for 
hearing has been made within 60 days after receipt of the 
reconsideration determination(s). Moreover, in the request for hearing, 
the appellants must specify the claims that they seek to aggregate.
    (c) The determination as to whether the amount in controversy is 
$100 or more is made by the administrative law judge (ALJ).
    (d) In determining the amount in controversy under paragraph (b) of 
this section, the ALJ also makes the determination as to what 
constitutes ``similar or related services'' or ``common issues of law 
and fact.''
    (e) When a civil action is filed by either an individual appellant 
or two or more appellants, the Secretary may assert that the aggregation 
principles contained in this subpart may be applied to determine the 
amount in controversy for judicial review ($1000).
    (f) Notwithstanding the provisions of paragraphs (a)(1) and (b)(1) 
of this section, when payment is made for certain excluded services 
under Sec. 411.400 of this chapter or the liability of the beneficiary 
for those services is limited under Sec. 411.402 of this chapter, the 
amount in controversy is computed as the amount that would have been 
charged the beneficiary for the items or services in question, less any 
deductible and coinsurance amounts applicable in the particular case, 
had such expenses not been paid pursuant to Sec. 411.400 of this chapter 
or had such liability not been limited pursuant to Sec. 411.402 of this 
chapter.
    (g) Under this subpart, an appellant may not combine part A and part 
B claims together to meet the requisite amount in controversy for a 
hearing. HMO, CMP and HCPP appellants under part 417 of this chapter may 
combine part A and part B claims together to meet the requisite amounts 
in controversy for a hearing.

[59 FR 12181, Mar. 16, 1994]



Sec. 405.745  Amount in controversy ascertained after reconsideration.

    For the purpose of determining whether a party to a reconsidered 
determination is entitled to a hearing, the amount in controversey after 
the reconsideration action rather than the amount in controversy 
initially at issue shall be controlling.

[40 FR 1026, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec. 405.747  Dismissal of request for hearing; amount in controversy less than $100.

    The ALJ shall, without holding a hearing, dismiss the request for 
hearing if the request for hearing plainly shows that less than $100 is 
in controversy. If a hearing is held and the ALJ finds that the amount 
in controversy is less than $100, the ALJ shall dismiss the request for 
hearing and will not rule on the substantive issues involved in the 
appeal.

[37 FR 5814, Mar. 23, 1972. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 62 FR 25855, May 12, 1997]

[[Page 105]]



Sec. 405.750  Time period for reopening initial, revised, or reconsidered determinations and decisions or revised decisions of an ALJ or the Departmental 
          Appeals Board (DAB); binding effect of determination and 
          decisions.

    (a) Reopenings concerning applications and entitlement. A 
determination, or decision, or revised determination or decision made by 
the SSA concerning any matter under Sec. 405.704(a), may be reopened and 
revised under 20 CFR 404.988 (Conditions for reopening).
    (b) Reopenings concerning a request for payment. An initial, 
revised, or reconsidered determination of HCFA, or a decision or revised 
decision of an ALJ or of the DAB, with respect to an individual's right 
concerning a request for payment under Medicare Part A, which is 
otherwise binding under 20 CFR 404.955 or 404.981 and Secs. 405.708 or 
405.717 of this subpart may be reopened:
    (1) Within 12 months from the date of the notice of the initial or 
reconsidered determination to the party to such determination;
    (2) After such 12-month period, but within 4 years after the date of 
the notice of the initial determination to the individual, upon 
establishment of good cause for reopening such determination or decision 
(see 20 CFR 404.988(b) and 404.989); or
    (3) At any time, when:
    (i) Such initial, revised, or reconsidered determination or such 
decision or revised decision is unfavorable, in whole or in part, to the 
party thereto, but only for the purpose of correcting clerical error or 
error on the face of the evidence on which such determination or 
decision was based; or
    (ii) Such initial, revised, or reconsidered determination or such 
decision or revised decision was procured by fraud or similar fault of 
the beneficiary or some other person.

[45 FR 73933, Nov. 7, 1980, as amended at 61 FR 32348, June 24, 1996; 62 
FR 25853, 25855, May 12, 1997]



Sec. 405.753  Appeal of a categorization of a device.

    (a) HCFA's acceptance of the FDA categorization of a device as an 
experimental/investigational (Category A) device under Sec. 405.203 is a 
national coverage decision under section 1862(a)(1) of the Act.
    (b) HCFA's acceptance of the FDA categorization of a device as an 
experimental/investigational (Category A) device under Sec. 405.203 is 
an aspect of an initial determination that, under section 1862 of the 
Act, payment may not be made.
    (c) In accordance with section 1869(b)(3)(A) of the Act, HCFA's 
acceptance of the FDA categorization of a device as an experimental/
investigational (Category A) device under Sec. 405.203 may not be 
reviewed by an administrative law judge.

[60 FR 48424, Sept. 19, 1995]



          Subpart H--Appeals Under the Medicare Part B Program

    Authority: Secs. 1102, 1842(b)(3)(C), 1869(b), and 1871 of the 
Social Security Act (42 U.S.C. 1302, 1395u(b)(3)(C), 1395ff(b), and 
1395hh).

    Source: 32 FR 18028, Dec. 16, 1967, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.



Sec. 405.801  Part B appeals--general description.

    (a) The Medicare carrier makes an initial determination when a 
request for payment for Part B benefits is submitted. If an individual 
beneficiary is dissatisfied with the initial determination, he or she 
may request, and the carrier will perform, a review of the claim. 
Following the carrier's review determination, the beneficiary may obtain 
a carrier hearing if the amount remaining in controversy is at least 
$100. The beneficiary is also entitled to a carrier hearing without the 
benefit of a review determination when the initial request for payment 
is not being acted upon with reasonable promptness (as defined in 
Sec. 405.802). Following the carrier hearing, the beneficiary may obtain 
a hearing before an ALJ if the amount remaining in controversy is at 
least $500. If the beneficiary is dissatisfied with the decision of the 
ALJ, he or she may request the Departmental Appeals Board (DAB) to 
review the case. Following the action of the DAB, the beneficiary may 
file suit in Federal district court if the amount remaining in 
controversy is at least $1,000.

[[Page 106]]

    (b) The rights of a beneficiary under paragraph (a) of this section 
to appeal the carrier's initial determination are granted also to--
    (1) A physician or supplier that furnishes services to a beneficiary 
and that accepts an assignment from the beneficiary, or
    (2) A physician who meets the conditions of section 1842(l)(1)(A) of 
the Act pertaining to refund requirements for nonparticipating 
physicians who have not taken assignment on the claim(s) at issue.
    (c) Procedures governing the determinations by SSA as to whether an 
individual has met basic Part B entitlement requirements are covered in 
subpart G of this part and 20 CFR part 404, subpart J. Subparts J and R 
of 20 CFR part 404 are also applicable to ALJ, DAB, and judicial review 
conducted under subpart H, except to the extent that specific provisions 
are contained in this subpart.

[62 FR 25853, May 12, 1997]



Sec. 405.802  Definitions.

    As used in subpart H of this part, the term--
    After receipt of the notice means 5 days after the date on the 
notice, unless it is shown that the notice was received earlier or 
later.
    Appellant designates the beneficiary, assignee or other person or 
entity that has filed an appeal concerning a particular determination of 
benefits under Medicare part B. Designation as an appellant does not in 
itself convey standing to appeal the determination in question.
    Assignee means a physician or supplier who furnishes services to a 
beneficiary under Medicare part B and who has accepted a valid 
assignment executed by the beneficiary.
    Assignment means the transfer by the assignor of his or her claim 
for payment to the assignee in return for the latter's promise not to 
charge more for his or her services than the carrier finds to be the 
reasonable charge or other approved amount.
    Assignor means a beneficiary under Medicare part B whose physician 
or supplier has taken assignment of a claim.
    Carrier means an organization which has entered into a contract with 
the Secretary pursuant to section 1842 of the Act and which is 
authorized to make determinations with respect to part B of title XVIII 
of the Act. For purposes of this subpart, the term carrier also refers 
to an intermediary that has entered into a contract with the Secretary 
under section 1816 of the Act and is authorized to make determinations 
with respect to part B provider services, as specified in Sec. 421.5(c) 
of this chapter.
    Common issues of law and fact, with respect to the aggregation of 
claims by two or more appellants to meet the minimum amount in 
controversy needed for an ALJ hearing, occurs when the claims sought to 
be aggregated are denied or reduced for similar reasons and arise from a 
similar fact pattern material to the reason the claims are denied.
    Delivery of similar or related services, with respect to the 
aggregation of claims by two or more physician/supplier appellants to 
meet the minimum amount in controversy needed for an ALJ hearing, means 
like or coordinated services or items provided to the same beneficiary 
by the appellants.
    Representative means an individual meeting the conditions described 
in Secs. 405.870 through 405.871.
    With reasonable promptness means within a period of 60 consecutive 
days after the receipt by the carrier of a request for payment.

[59 FR 12182, Mar. 16, 1994, as amended at 62 FR 25853, May 12, 1997]



Sec. 405.803  Initial determination.

    (a) Carriers make initial determinations regarding claims for 
benefits under Medicare Part B.
    (b) An initial determination for purposes of this subpart includes 
determinations such as the following:
    (1) Whether services furnished are covered.
    (2) Whether the deductible has been met.
    (3) Whether the receipted bill or other evidence of payment is 
acceptable.
    (4) Whether the charges for services furnished are reasonable.

[[Page 107]]

    (5) If the services furnished to a beneficiary by a physician or a 
supplier pursuant to an assignment under Sec. 424.55 of this chapter are 
not covered because they are determined to be not reasonable and 
necessary under Sec. 411.15(k) of this chapter, whether the beneficiary, 
physician or supplier, or a physician who meets the requirements of 
Sec. 411.408, knew or could reasonably have been expected to know at the 
time the services were furnished that the services were not covered.
    (c) The following are not initial determinations for purposes of 
this subpart:
    (1) Any issue or factor for which SSA or HCFA has sole 
responsibility, for example, whether an independent laboratory meets the 
conditions for coverage of services; whether a Medicare overpayment 
claim should be compromised, or collection action terminated or 
suspended.
    (2) Any issue or factor which relates to hospital insurance benefits 
under Medicare Part A.

[62 FR 25853, May 12, 1997]



Sec. 405.804  Notice of initial determination.

    After a carrier has made an initial determination on a request for 
payment written notice of this determination shall be mailed to each 
party to the determination at his last known address. The notice of the 
determination shall inform each party to the determination of his right 
to have such determination reviewed.



Sec. 405.805  Parties to the initial determination.

    The parties to the initial determination (see Sec. 405.803) may be 
any party described in Sec. 405.802.

[64 FR 52670, Sept. 30, 1999]



Sec. 405.806  Effect of Initial Determination.

    The initial determination is binding upon all parties to the claim 
for benefits unless the determination is--
    (a) Reviewed in accordance with Secs. 405.810 through 405.812; or
    (b) Revised as a result of a reopening in accordance with 
Sec. 405.841.

[62 FR 25853, May 12, 1997]



Sec. 405.807  Request for review of initial determination.

    (a) General. A party to an initial determination by a carrier, that 
is dissatisfied with the initial determination and wants to appeal the 
matter, may request that the carrier review the determination. The 
request for review by the party to an initial determination must clearly 
indicate that he or she is dissatisfied with the initial determination 
and wants to appeal the matter. The request for review does not 
constitute a waiver of the party's right to a hearing (under 
Sec. 405.815) after the review.
    (b) Place and method of filing a request. A request by a party for a 
carrier to review the initial determination may be made in one of the 
following ways:
    (1) In writing and filed at an office of the carrier, SSA, or HCFA.
    (2) By telephone to the telephone number designated by the carrier 
as the appropriate number for the receipt of requests for review.
    (c) Time of filing request. (1) The carrier must provide a period of 
6 months after the date of the notice of the initial determination 
within which the party to the initial determination may request a 
review.
    (2) The carrier may, upon request by the party, extend the period 
for requesting the review of the initial determination.

[64 FR 52670, Sept. 30, 1999]



Sec. 405.808  Parties to the review.

    The parties to the review (as provided for in Sec. 405.807(a)) shall 
be the persons who were parties to the carrier's initial determination 
as described in Sec. 405.805, and any other party whose rights with 
respect to the particular claim being reviewed may be affected by such 
review.

[39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec. 405.809  Opportunity to submit evidence.

    The parties to the review (as provided for in Sec. 405.807(a)) shall 
have a

[[Page 108]]

reasonable opportunity to submit written evidence and contentions as to 
fact or law relative to the claim at issue.

[39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec. 405.810  Review determination.

    Subject to the provisions of Secs. 405.807 through 405.809, the 
carrier shall review the claim in dispute and, upon the basis of the 
evidence of record, shall make a separate determination affirming or 
revising in whole or in part the findings and determination in question.

[39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec. 405.811  Notice of review determination.

    Written notice of the review determination is mailed to a party at 
his or her last known address. The review determination states the basis 
of the determination and advises the party of his or her right to a 
carrier hearing when the amount in controversy is $100 or more as 
determined in accordance with Sec. 405.817. The notice states the place 
and manner of requesting a carrier hearing as well as the time limit 
under which a hearing must be requested (see Sec. 405.821).

[59 FR 12182, Mar. 16, 1994]



Sec. 405.812  Effect of review determination.

    The review determination is binding upon all parties to the review 
unless a carrier hearing decision is issued pursuant to a request for 
hearing made in accordance with Sec. 405.821 or is revised as a result 
of reopening in accordance with Sec. 405.841.

[59 FR 12182, Mar. 16, 1994, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.815  Amount in controversy for carrier hearing, ALJ hearing and judicial review.

    Any party designated in Sec. 405.822 is entitled to a carrier 
hearing after a review determination has been made by the carrier if the 
amount remaining in controversy is $100 or more and the party meets the 
requirements of Sec. 405.821 of this subpart. To be entitled to a 
hearing before an ALJ following the carrier hearing, the amount 
remaining in controversy must be $500 or more, and for judicial review 
following the ALJ hearing and Departmental Appeals Board Review, the 
amount remaining in controversy must be $1000 or more.

[59 FR 12182, Mar. 16, 1994, as amended at 61 FR 32348, June 24, 1996]



Sec. 405.817  Principles for determining amount in controversy.

    (a) Individual appellants. For the purpose of determining whether an 
individual appellant meets the minimum amount in controversy needed for 
a carrier hearing ($100) or ALJ hearing ($500), the following rules 
apply:
    (1) The amount in controversy is computed as the actual amount 
charged the individual for the items and services in question, less any 
amount for which payment has been made by the carrier and less any 
deductible and coinsurance amounts applicable in the particular case.
    (2) A single beneficiary may aggregate claims from two or more 
physicians/suppliers to meet the $100 or $500 thresholds. A single 
physician/supplier may aggregate claims from two or more beneficiaries 
to meet the $100 or $500 threshold levels of appeal.
    (3) In either of the circumstances specified in paragraph (a)(2) of 
this section, two or more claims may be aggregated by an individual 
appellant to meet the amount in controversy for a carrier hearing only 
if the claims have previously been reviewed and a request for hearing 
has been made within six months after the date of the review 
determination(s).
    (4) In either of the circumstances specified in paragraph (a)(2) of 
this section, two or more claims may be aggregated by an individual 
appellant to meet the amount in controversy for an ALJ hearing only if 
the claims have previously been decided by a carrier hearing officer and 
a request for an ALJ hearing has been made within 60 days after receipt 
of the carrier hearing officer decision(s).
    (5) When requesting a carrier hearing or an ALJ hearing, the 
appellant must specify in his or her appeal request the specific claims 
to be aggregated.
    (b) Two or more appellants. As specified in this paragraph, under 
section

[[Page 109]]

1869(b)(2) of the Act, two or more appellants may aggregate their claims 
together to meet the minimum amount in controversy needed for an ALJ 
hearing ($500). The right to aggregate under this statutory provision 
applies to claims for items and services furnished on or after January 
1, 1987.
    (1) The aggregate amount in controversy is computed as the actual 
amount charged the individual(s) for the items and services in question, 
less any amount for which payment has been made by the carrier and less 
any deductible and coinsurance amounts applicable in the particular 
case.
    (2) In determining the amount in controversy, two or more appellants 
may aggregate their claims together under the following circumstances:
    (i) Two or more beneficiaries may combine claims representing 
services from the same or different physician(s) or supplier(s) if the 
claims involve common issues of law and fact;
    (ii) Two or more physicians/suppliers may combine their claims if 
the claims involve the delivery of similar or related services to the 
same beneficiary;
    (iii) Two or more physicians/suppliers may combine their claims if 
the claims involve common issues of law and fact with respect to 
services furnished to two or more beneficiaries.
    (iv) In any of the circumstances specified in paragraphs (b)(2)(i) 
through (b)(2)(iii) of this section, the claims may be aggregated only 
if the claims have previously been decided by a carrier hearing 
officer(s) and a request for ALJ hearing has been made within 60 days 
after receipt of the carrier hearing officer decision(s). Moreover, in a 
request for ALJ hearing, the appellants must specify the claims that 
they seek to aggregate.
    (c) The determination as to whether the amount in controversy is 
$100 or more is made by the carrier hearing officer. The determination 
as to whether the amount in controversy is $500 or more is made by the 
ALJ.
    (d) In determining the amount in controversy under paragraph (b) of 
this section, the ALJ will also make the determination as to what 
constitutes ``similar or related services'' or ``common issues of law 
and fact.''
    (e) When a civil action is filed by either an individual appellant 
or two or more appellants, the Secretary may assert that the aggregation 
principles contained in this subpart may be applied to determine the 
amount in controversy for judicial review ($1000).
    (f) Notwithstanding the provisions of paragraphs (a)(1) and (b)(1) 
of this section, when payment is made for certain excluded services 
under Sec. 411.400 of this chapter or the liability of the beneficiary 
for those services is limited under Sec. 411.402 of this chapter, the 
amount in controversy is computed as the amount that would have been 
charged the beneficiary for the items or services in question, less any 
deductible and coinsurance amounts applicable in the particular case, 
had such expenses not been paid under Sec. 411.400 of this chapter or 
had such liability not been limited under Sec. 411.402 of this chapter.
    (g) Under this subpart, an appellant may not combine part A and part 
B claims together to meet the requisite amount in controversy for a 
carrier hearing or ALJ hearing. HMO, CMP and HCPP appellants under part 
417 of this chapter may combine part A and part B claims together to 
meet the requisite amount in controversy for a hearing.

[59 FR 12182, Mar. 16, 1994]



Sec. 405.821  Request for carrier hearing.

    (a) A request for a carrier hearing is any clear expression in 
writing by a claimant asking for a hearing to adjudicate a claim when 
not acted upon with reasonable promptness or by a party to a review 
determination who states, in effect, that he or she is dissatisfied with 
the carrier's review determination and wants further opportunity to 
appeal the matter to the carrier.
    (b) The hearing request must be filed at an office of the carrier or 
at an office of SSA or HCFA.
    (c) Except when a carrier hearing is held because the carrier did 
not act upon a claim with reasonable promptness, a party to the review 
determination may request a carrier hearing within six months after the 
date of the notice of the review determination. The carrier may, upon 
request by the

[[Page 110]]

party affected, extend the period for filing the request for hearing.

[59 FR 12183, Mar. 16, 1994, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.822  Parties to a carrier hearing.

    The parties to a hearing shall be the persons who were parties to 
the carrier's review determination (Sec. 405.808) which is in question. 
Any other person may be made a party if that person's rights with 
respect to supplementary medical insurance benefits may be prejudiced by 
the decision.

[39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 59 FR 12183, Mar. 16, 1994]



Sec. 405.823  Carrier hearing officer.

    Any hearing provided for in this subpart shall be conducted by a 
hearing officer designated by the appropriate official of the carrier.

[39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 59 FR 12183, Mar. 16, 1994]



Sec. 405.824  Disqualification of carrier hearing officer.

    A hearing officer shall not conduct a hearing in any case in which 
he is prejudiced or partial with respect to any party, or if he has any 
interest in the matter before him. Notice of any objection with respect 
to the hearing officer who will conduct the hearing shall be made by the 
objecting party at his earliest opportunity. The hearing officer shall 
consider such objection and shall, at his discretion, withdraw. If the 
hearing officer withdraws, the appropriate official of the carrier shall 
designate another hearing officer to conduct the hearing. If the hearing 
officer does not withdraw, the objecting party may present his 
objections to the carrier for consideration at any time prior to the 
issuance of a decision. The carrier shall review the request and take 
appropriate action. The fact that a hearing officer is an employee of 
the carrier may not serve as prima facie cause for disqualification.

[32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 59 FR 12183, Mar. 16, 1994]



Sec. 405.825  Location of carrier hearing.

    (a) Time and place. The hearing officer shall fix a time and place 
for the hearing reasonably convenient to the requesting party and not 
inconsistent with the public interest.
    (b) Adjournment or postponement. The hearing officer may, for a good 
and sufficient reason, fix a new time and/or place for the hearing; he 
may change the time and place for the hearing or adjourn the hearing on 
his own motion upon reasonable notification to the parties.

[32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 59 FR 12183, Mar. 16, 1994]



Sec. 405.826  Notice of carrier hearing.

    The notice of hearing is to include notice of the time and place of 
the hearing; information as to the specific issues to be determined; and 
the matters on which findings will be made and conclusions will be 
reached. The notice is to contain sufficient information about the 
hearing procedure (including the party's right to representation) for 
effective preparation for the hearing.

[32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 59 FR 12183, Mar. 16, 1994]



Sec. 405.830  Conduct of the carrier hearing.

    (a) General. Hearings shall be open to the parties and to such other 
persons as the hearing officer deems necessary and proper for the 
orderly and efficient conduct of the hearing. The hearing officer shall 
inquire fully into the matters at issue and shall receive in evidence 
the testimony of witnesses and any documents which are relevant and 
material to such matters. The parties shall be provided an opportunity 
to enter any objection to the inclusion of any document. The order in 
which evidence and allegations shall be presented and the procedure at 
the hearing, except as this subpart otherwise expressly provides, shall 
be at the discretion of the hearing officer and of such nature as to 
afford the parties a proper hearing.

[[Page 111]]

    (b) Evidence. Evidence may be received at the hearing even though 
inadmissible under rules of evidence applicable to court procedures.
    (c) Witnesses. The hearing officer may examine the witnesses and 
shall allow the parties or their representatives to do so. If the 
hearing officer conducts the examination of a witness, he may allow the 
parties to suggest matters upon which they desire the witness to be 
questioned, and the hearing officer shall question the witness with 
respect to such matters if they are relevant and material to any issue 
pending for decision before him.
    (d) Oral argument and written allegations. The parties, upon their 
request shall be allowed a reasonable time for the presentation of oral 
argument or for the filing of briefs or other written statements or 
allegations of facts or law.
    (e) Consolidated issues. When one or more new issues are raised at 
any time after a request for hearing has been made, but before the 
mailing of notice of the decision, the hearing officer may, at his 
discretion, consider the issues along with the other issues pending 
before him on the same request for hearing.

[32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 59 FR 12183, Mar. 16, 1994]



Sec. 405.831  Waiver of right to appear at carrier hearing and present evidence.

    If all parties waive their right to appear before the hearing 
officer and present evidence and contentions personally or by 
representative, it shall not be necessary for the hearing officer to 
give notice of or conduct a formal hearing as provided in Secs. 405.825 
through 405.830. A waiver of the right to appear is to be in writing and 
filed with the hearing officer or the carrier. Such waiver may be 
withdrawn by a party at any time prior to the mailing of notice of the 
decision in the case. Even though all of the parties have filed a waiver 
of the right to appear and present evidence and contentions at a hearing 
before the hearing officer, the hearing officer may, nevertheless, give 
notice of a time and place and conduct a hearing as provided in 
Secs. 405.825 through 405.830, if he believes that the personal 
appearance and testimony of the party or parties would assist him to 
ascertain the facts at issue in the case. For purposes of this section, 
failure of the parties to appear shall not be cause for a finding of 
abandonment and the hearing officer shall make his decision on the basis 
of all evidence adduced.

[32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 62 FR 25855, May 12, 1997]



Sec. 405.832  Dismissal of request for carrier hearing.

    (a) By application of party. With the approval of the hearing 
officer, a request for a hearing may be withdrawn or dismissed at any 
time prior to the mailing of notice of the decision upon the application 
of the party or parties filing the request for such hearing. A party may 
request a dismissal by filing a written notice of such request with the 
carrier, the hearing officer or orally stating such request at the 
hearing. The dismissal of a request for hearing shall be binding unless 
vacated (see paragraph (d) of this section).
    (b) Dismissal by abandonment of party. A hearing officer may dismiss 
a request for hearing upon abandonment by the party or parties who filed 
the request. A party shall be deemed to have abandoned a request for 
hearing, other than where personal appearance is waived in accordance 
with Sec. 405.831, if neither the party nor his representative appears 
at the time and place fixed for the hearing and within 10 days after the 
mailing of a notice to him by the hearing officer to show cause, such 
party does not show good and sufficient cause for such failure to appear 
and failure to notify the hearing officer prior to the time fixed for 
hearing that he cannot appear.
    (c) Dismissal for cause. The hearing officer may, on his own motion, 
dismiss a hearing request, either entirely or as to any stated issue, 
under either of the following circumstances:
    (1) Where the party requesting a hearing is not a proper party under 
Sec. 405.822 or does not otherwise have a right to a hearing under 
section 1842(b)(3)(C) of the Act; or

[[Page 112]]

    (2) Where the party who filed the hearing request dies and there is 
no information before the hearing officer showing that an individual who 
is not a party may be prejudiced by the carrier's determination.
    (d) Dismissal without prejudice. The hearing officer may on his own 
motion dismiss without prejudice a hearing request where the amount in 
controversy is less than $100.
    (e) Vacation of dismissal. A hearing officer may, on request of a 
party and for good and sufficient cause shown, vacate any dismissal of a 
request for hearing at any time within 6 months from the date of mailing 
notice of the dismissal to the party requesting the hearing at his last 
known address.

[32 FR 18028, Dec. 16, 1967, as amended at 39 FR 12098, Apr. 3, 1974. 
Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, 
Mar. 16, 1994; 62 FR 25855, May 12, 1997]



Sec. 405.833  Record of carrier hearing.

    A complete record of the proceedings at the carrier hearing is made. 
The testimony is transcribed and copies of other documentary evidence 
are reproduced in any case when directed by the hearing officer, the 
carrier, or HCFA. The record will also be transcribed and reproduced at 
the request of any party to the hearing provided the requesting party 
bears the cost.

[62 FR 25853, May 12, 1997]



Sec. 405.834  Carrier hearing officer's decision.

    (a) As soon as practicable after the close of a carrier hearing, the 
carrier hearing officer issues a decision in the case based upon the 
evidence presented at the hearing or otherwise included in the hearing 
record. The decision is issued as a written notice to the parties and 
contains--
    (1) Findings of fact,
    (2) A statement of reasons, and
    (3) Notification to the parties of their right to an ALJ hearing 
when the amount remaining in controversy is at least $500.
    (b) A copy of the decision is mailed to the parties to the hearing 
at their last known addresses.

[62 FR 25854, May 12, 1997]



Sec. 405.835  Effect of carrier hearing officer's decision.

    The carrier hearing officer's decision is binding upon all parties 
to the hearing unless--
    (a) A request for an ALJ hearing is filed in accordance with 
Sec. 405.855, or
    (b) The decision is revised in accordance with Sec. 405.841.

[62 FR 25854, May 12, 1997]



Sec. 405.836  Authority of the carrier hearing officer.

    The carrier hearing officer, in adjudicating Medicare Part B claims, 
complies with all of the provisions of, and regulations issued under, 
title XVIII of the Act, as well as with HCFA Rulings, national coverage 
decisions, and other policy statements, instructions, and guides issued 
by HCFA.

[62 FR 25854, May 12, 1997]



Sec. 405.841  Reopening initial or review determination of the carrier, and decision of a carrier hearing officer.

    An initial or review determination of a carrier or a decision of a 
hearing officer may be reopened by such carrier or hearing officer:
    (a) Within 12 months from the date of the notice of such initial or 
review determination or decision to the party to such determination or 
decision; or
    (b) After such 12-month period, but within 4 years from the date of 
the notice of the initial determination to the party to such 
determination, upon establishment of good cause for reopening such 
determination or decision (see 20 CFR 404.988(b) and 404.989); or
    (c) At any time, when:
    (1) Such initial or review determination or decision was procured by 
fraud or similar fault of the beneficiary or some other person, or
    (2) Such initial or review determination or decision is unfavorable, 
in whole or in part, to the party thereto, but only for the purpose of 
correcting a clerical error or error on the face of the evidence on 
which such determination or decision was based.

[39 FR 12098, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 59 FR 12183, Mar. 16, 1994; 62 FR 25855, May 12, 1997]

[[Page 113]]



Sec. 405.842  Notice of reopening and revision.

    (a) Notice. When any determination or decision is reopened as 
provided in Sec. 405.841, notice of such reopening shall be mailed to 
the parties to such determination or decision at their last known 
addresses. A notice of revision following a reopening of a decision, 
shall be mailed to the parties and shall state the basis for the revised 
determination or decision.
    (b) Effect of revised determination. The revision of a determination 
(see Sec. 405.841) shall be binding upon all parties thereto unless a 
party files a written request for a hearing with respect to a revised 
determination when the amount in controversy is $100 or more.

[32 FR 18028, Dec. 16, 1967, as amended at 39 FR 12098, Apr. 3, 1974. 
Redesignated at 42 FR 52826, Sept. 30, 1977; 62 FR 25855, May 12, 1997]



Sec. 405.850  Change of ruling or legal precedent.

    Change of a legal interpretation or administrative ruling upon which 
a determination or decision was made shall not be considered as good and 
sufficient reason for reopening the determination or decision.



Sec. 405.853  Expedited appeals process.

    (a) Conditions for use of expedited appeals process (EAP). A party 
may use the EAP set forth in Sec. 405.718 of this chapter to request 
court review in place of the ALJ hearing or Departmental Appeals Board 
(DAB) review if the following conditions are met:
    (1) The carrier hearing officer has made a decision; an ALJ has made 
a hearing decision; or DAB review has been requested, but a final 
decision has not been issued.
    (2) The filing entity is a party referred to in Sec. 405.718(d) of 
this chapter.
    (3) The party has filed a request for an ALJ hearing in accordance 
with Sec. 405.855, or DAB review in accordance with 20 CFR 404.968.
    (4) The amount remaining in controversy is $1,000 or more.
    (5) If there is more than one party to the hearing decision, each 
party concurs, in writing, with the request for an EAP.
    (b) Content of the request for EAP. The request for an EAP:
    (1) Alleges that there are no material issues of fact in dispute; 
and
    (2) Asserts that the only factor precluding a decision favorable to 
the party is a statutory provision that is unconstitutional or a 
regulation, national coverage decision under section 1862(a)(1) of the 
Act, or HCFA Ruling that is invalid.

[62 FR 25854, May 12, 1997]



Sec. 405.855  ALJ hearing.

    (a) Right to hearing. A party to the carrier hearing has a right to 
a hearing before an ALJ if--
    (1) The party files a written request for an ALJ hearing within 60 
days after receipt of the notice of the carrier hearing decision; and
    (2) The amount remaining in controversy is $500 or more.
    (b) Place of filing hearing request. The request for an ALJ hearing 
must be made in writing and filed with the carrier that issued the 
decision, a Social Security office, or, in the case of a qualified 
railroad retirement beneficiary, an office of the Railroad Retirement 
Board.
    (c) Effect of ALJ hearing decision. (1) An ALJ's decision is binding 
on all parties to the hearing unless--
    (i) The DAB reviews the ALJ decision;
    (ii) The DAB does not review the ALJ decision, and the party 
requests judicial review;
    (iii) The decision is revised by the DAB or an ALJ in accordance 
with the provisions of Sec. 405.750 of this chapter; or
    (iv) The expedited appeals process is used.

[62 FR 25854, May 12, 1997]



Sec. 405.856  Departmental Appeals Board (DAB) review.

    Regulations beginning at 20 CFR 404.967 regarding SSA Appeals 
Council Review are applicable to DAB review of matters addressed by this 
subpart.

[62 FR 25854, May 12, 1997]



Sec. 405.857  Court review.

    (a) General rule. To the extent authorized by sections 1869, 
1876(c)(5)(B), and 1879(d) of the Act, a party to a DAB decision, or an 
ALJ decision if the DAB does not review the ALJ's decision,

[[Page 114]]

may obtain a court review if the amount remaining in controversy is 
$1,000 or more. A party may obtain court review by filing a civil action 
in a district court of the United States in accordance with the 
provisions of section 205(g) of the Act. The filing procedure is set 
forth in 20 CFR 422.210.
    (b) Prohibition against court review of certain Part B regulations 
or instructions. Under section 1869(b)(4) of the Act, a court may not 
review a regulation or instruction that relates to a method of payment 
under Part B if the regulation was promulgated, or the instruction 
issued, before January 1, 1981.

[62 FR 25854, May 12, 1997]



Sec. 405.860  Review of national coverage decisions (NCDs).

    (a) General. (1) HCFA makes NCDs either granting, limiting, or 
excluding Medicare coverage for a specific medical service, procedure or 
device. NCDs are made under section 1862(a)(1) of the Act or other 
applicable provisions of the Act. An NCD is binding on all Medicare 
carriers, fiscal intermediaries, PROs, HMOs, CMPs, and HCPPs when 
published in HCFA program manuals or the Federal Register.
    (2) Under section 1869(b)(3) of the Act, only NCDs made under 
section 1862(a)(1) of the Act are subject to the conditions of 
paragraphs (b) through (d) of this section.
    (b) Review by ALJ. (1) An ALJ may not disregard, set aside, or 
otherwise review an NCD.
    (2) An ALJ may review the facts of a particular case to determine 
whether an NCD applies to a specific claim for benefits and, if so, 
whether the NCD has been applied correctly to the claim.
    (c) Review by Court. (1) A court's review of an NCD is limited to 
whether the record is incomplete or otherwise lacks adequate information 
to support the validity of the decision, unless the case has been 
remanded to the Secretary to supplement the record regarding the NCD. 
The court may not invalidate an NCD except upon review of the 
supplemented record.
    (2) A Federal court may not hold unlawful or set aside an NCD 
because it was not issued in accordance with the notice and comment 
procedures of the Administrative Procedure Act (5 U.S.C. 553) or section 
1871(b) of the Act.
    (d) Remands--(1) Secretary's action. When a court remands an NCD 
matter to the Secretary because the record in support of the NCD is 
incomplete or otherwise lacks adequate information, the Secretary 
remands the case to HCFA in order to supplement the record.
    (2) Remand to HCFA. HCFA supplements the record with new or updated 
evidence, including additional information from other sources, and may 
issue a revised NCD.
    (3) Final Actions. (i) The proceedings to supplement the record, are 
expedited.
    (ii) When HCFA does not issue a revised NCD, it returns the 
supplemented record to the court for review.
    (iii) When HCFA issues a revised NCD, it forwards the case to an ALJ 
who issues a new decision applying the revised NCD to the facts of the 
claim(s) under consideration. The ALJ's decision is subject to DAB 
review and, ultimately, judicial review.

[62 FR 25854, May 12, 1997]



Sec. 405.870  Appointment of representative.

    A party to an initial determination, informal review or hearing as 
provided in Secs. 405.803 through 405.934, may appoint as his 
representative in any such proceeding any person qualified under 
Sec. 405.871. Where the representative is an attorney, in the absence of 
information to the contrary, his representation that he has such 
authority shall be accepted as evidence of the attorney's authority to 
represent a party.



Sec. 405.871  Qualifications of representatives.

    Any individual may be appointed to act as representative in 
accordance with Sec. 405.870, unless he is disqualified or suspended 
from acting as a representative in proceedings before the SSA or the 
HCFA or unless otherwise prohibited by law.

[39 FR 12098, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 62 FR 25855, May 12, 1997]

[[Page 115]]



Sec. 405.872  Authority of representatives.

    A representative, appointed and qualified as provided in 
Secs. 405.870 and 405.871, may make or give, on behalf of the party he 
represents, any request or notice relative to any proceeding before the 
carrier including review and hearing. A representative shall be entitled 
to present evidence and allegations as to facts and law in any 
proceeding affecting the party he represents and to obtain information 
with respect to the claim of such party to the same extent as such 
party. Notice to any party or any action, determination, or decision, or 
request to any party for the production of evidence, shall be sent to 
the representative of such party.



Sec. 405.874  Appeals of carrier decisions that supplier standards are not met.

    (a) An entity serving as a National Supplier Clearinghouse must act 
promptly to determine if any entity submitting a request for a billing 
number as a Medicare supplier of part B items meets the standards set 
forth in part 424. Effective July 1, 1993, the National Supplier 
Clearinghouse must accept, reject or request additional information 
within 15 days of the receipt of an enrollment application.
    (b) If the National Supplier Clearinghouse disallows an entity's 
request for a billing number or revokes, with the concurrence of HCFA, 
an entity's billing number, the National Supplier Clearinghouse notifies 
the entity by certified mail. Revocation is effective 15 days after the 
National Supplier Clearinghouse mails notice of its determination. The 
carrier disallows payment for items furnished by the supplier beginning 
with that effective date. The notice must inform the entity of the 
reason for the rejection or revocation, its right to appeal, the date by 
which it must file that appeal (90 days after the postmark of the 
notice) and the address to which the appeal must be sent in writing.
    (c) A fair hearing officer not involved in the original 
determination to disallow an entity's request for a billing number, or 
to revoke an entity's billing number, must schedule a hearing to be held 
within one week of receipt of an appeal, or later at the request of the 
entity. Both the entity and carrier may offer evidence. The hearing 
officer issues notice of his/her decision within 2 weeks of the hearing. 
The notice is sent by certified letter to HCFA, the carrier, and the 
appealing entity. This notice must include information about the 
supplier's further right to appeal, the carrier's right to appeal, the 
date by which the appeal must be filed (90 days after the postmark of 
the notice) and the address to which the appeals must be sent in 
writing. Either the carrier or entity may appeal the hearings officer's 
decision to HCFA.
    (d) A HCFA official, designated by the Administrator of HCFA, must 
make an appeal decision based on the evidence presented to the fair 
hearing officer and his or her decision. The HCFA official requests any 
additional information he or she deems necessary from either the carrier 
or the entity within two weeks of receipt by the HCFA of the appeal. 
Notice of the HCFA official's decision--
    (1) Is issued within two weeks of when the last information is 
received is received by the HCFA official, or four weeks of when the 
information is requested, whichever is shorter, unless the party 
appealing the fair hearing decision requests a delay;
    (2) Is sent by the HCFA official by certified mail to both the 
carrier and the entity; and
    (3) Contains information on any further appeals the entity and 
carrier may have.
    (e) A billing number is not issued, or remains revoked, and payment 
is not made, for items or services furnished by any entity which a 
carrier determines does not qualify for a billing number, until the 
carrier (upon reapplication of the entity), a fair hearing officer, or a 
HCFA official designated to hear such appeals, determines that the 
entity qualifies for a billing number. Any claims for items or services 
furnished after revocation of the supplier's billing number and 
submitted by the entity during the appeals period are held and not 
processed, i.e., are neither approved, denied or developed, until all 
administrative appeals have been exhausted. If an entity is determined 
not to have qualified for a billing number in one period but to

[[Page 116]]

have qualified in another, the carrier pays for claims for items sold or 
rented to beneficiaries during the period the entity qualified as a 
supplier. If there is evidence of an overpayment, see subpart C of part 
405 of this Chapter.
    (f) A billing number may be reinstated after revocation when an 
entity completes a corrective action plan, to which HCFA has agreed, and 
provided sufficient assurance of its intent to comply fully with the 
supplier standards.

[57 FR 27305, June 18, 1992]



Sec. 405.877  Appeal of a categorization of a device.

    (a) HCFA's acceptance of the FDA categorization of a device as an 
experimental/investigational (Category A) device under Sec. 405.203 is a 
national coverage decision under section 1862(a)(1) of the Act.
    (b) HCFA's acceptance of the FDA categorization of a device as an 
experimental/investigational (Category A) device under Sec. 405.203 is 
an aspect of an initial determination that, under section 1862 of the 
Act, payment may not be made.
    (c) In accordance with section 1869(b)(3)(A) of the Act, HCFA's 
acceptance of the FDA categorization of a device as an experimental/
investigational (Category A) device under Sec. 405.203 may not be 
reviewed by an administrative law judge.

[60 FR 48424, Sept. 19, 1995]

Subparts I-Q--[Reserved]



      Subpart R--Provider Reimbursement Determinations and Appeals

    Authority: Secs. 205, 1102, 1814(b), 1815(a), 1833, 1861(v), 1871, 
1872, 1878, and 1886 of the Social Security Act (42 U.S.C. 405, 1302, 
1395f(b), 1395g(a), 1395l, 1395x(v), 1395hh, 1395ii, 1395oo, and 
1395ww).

    Source: 39 FR 34515, Sept. 26, 1974, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.



Sec. 405.1801  Introduction.

    (a) Definitions. As used in this subpart:
    Administrator means the Administrator or Deputy Administrator of 
HCFA.
    Administrator's review means that review provided for in section 
1878(f) of the Act (42 U.S.C. 1395oo(f)) and Sec. 405.1875.
    Board means the Provider Reimbursement Review Board established in 
accordance with section 1878 of the Act (42 U.S.C. 1395oo) and 
Sec. 405.1845.
    Board hearing means that hearing provided for in section 1878(a) of 
the Act (42 U.S.C. 1395oo(a)), and Sec. 405.1835.
    Date of filing and date of submission of materials mean the day of 
the mailing (as evidenced by the postmark) or hand-delivery of 
materials, unless otherwise defined in this subpart.
    Date of receipt means the date on the return receipt of ``return 
receipt requested'' mail, unless otherwise defined in this subpart.
    Intermediary determination means the following:
    (1) With respect to a provider of services that has filed a cost 
report under Secs. 413.20 and 413.24(f) of this chapter, the term means 
a determination of the amount of total reimbursement due the provider, 
pursuant to Sec. 405.1803 following the close of the provider's cost 
reporting period, for items and services furnished to beneficiaries for 
which reimbursement may be made on a reasonable cost basis under 
Medicare for the period covered by the cost report.
    (2) With respect to a hospital that receives payments for inpatient 
hospital services under the prospective payment system (part 412 of this 
chapter), the term means a determination of the total amount of payment 
due the hospital, pursuant to Sec. 405.1803 following the close of the 
hospital's cost reporting period, under that system for the period 
covered by the determination.
    (3) For purposes of appeal to the Provider Reimbursement Review 
Board, the term is synonymous with the phrases ``intermediary's final 
determination'' and ``final determination of the Secretary'', as those 
phrases are used in section 1878(a) of the Act.
    (4) For purposes of Sec. 405.376 concerning claims collection 
activities, the term does not include an action by HCFA with respect to 
a compromise of

[[Page 117]]

a Medicare overpayment claim, or termination or suspension of collection 
action on an overpayment claim, against a provider or physician or other 
supplier.
    Intermediary hearing means that hearing provided for in 
Sec. 405.1809.
    (b) General rule--(1) Providers. The principles of reimbursement for 
determining reasonable cost and prospective payment are contained in 
parts 413 and 412, respectively, of this chapter. In order to be 
reimbursed for covered services furnished to Medicare beneficiaries, 
providers of services are obliged to file cost reports with their 
intermediaries as specified in Sec. 413.24(f) of this chapter. Where the 
term ``provider'' appears in this subpart, it includes hospitals paid 
under the prospective payment system for purposes of applying the appeal 
procedures described in this subpart to those hospitals.
    (2) Other entities participating in Medicare Part A. In addition to 
providers of services whose status as such is indicated in the Act, 
there are entities (such as health maintenance organizations) that do 
not meet the statutory test for providers of services, which may also 
participate in Medicare. These entities are required to file periodic 
cost reports and are reimbursed on the basis of information furnished in 
the reports. Although the entities do not qualify for Board review, the 
rules as set forth in this subpart with respect to intermediary hearings 
are applicable to the entities to the maximum extent possible, for cost-
reporting periods ending on or after December 31, 1971, where the amount 
of program reimbursement in controversy is at least $1,000.
    (c) Effective dates. (1) Except as provided in paragraphs (c)(2) and 
(c)(3) of this section or in Sec. 405.1885(e), this subpart applies to 
all cost reporting periods ending on or after December 31, 1971, for 
which reimbursement may be made on a reasonable cost basis.
    (2) Sections 405.1835 to 405.1877 apply only to cost reporting 
periods ending on or after June 30, 1973, for which reimbursement may be 
made on a reasonable cost basis.
    (3) With respect to hospitals under the prospective payment system 
(see part 412 of this chapter), the appeals procedures in Secs. 405.1811 
to 405.1877 that apply become applicable with the hospital's first cost 
reporting period beginning on or after October 1, 1983.

[39 FR 34515, Sept. 26, 1974. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 48 FR 39834, Sept. 1, 1983; 48 FR 45773, Oct. 7, 
1983; 49 FR 322, Jan. 3, 1984; 49 FR 23013, June 1, 1984; 51 FR 34793, 
Sept. 30, 1986; 61 FR 63749, Dec. 2, 1996]



Sec. 405.1803  Intermediary determination and notice of amount of program reimbursement.

    (a) General requirement. Upon receipt of a provider's cost report, 
or amended cost report where permitted or required, the intermediary 
must within a reasonable period of time (see Sec. 405.1835(b)), furnish 
the provider and other parties as appropriate (see Sec. 405.1805) a 
written notice reflecting the intermediary's determination of the total 
amount of reimbursement due the provider. The intermediary must include 
the following information in the notice, as appropriate:
    (1) Reasonable cost. The notice must--
    (i) Explain the intermediary's determination of total program 
reimbursement due the provider on the basis of reasonable cost for the 
reporting period covered by the cost report or amended cost report; and
    (ii) Relate this determination to the provider's claimed total 
program reimbursement due the provider for this period.
    (2) Prospective payment. With respect to a hospital that receives 
payments for inpatient hospital services under the prospective payment 
system (see part 412 of this chapter), the intermediary must include in 
the notice its determination of the total amount of the payments due the 
hospital under that system for the cost reporting period covered by the 
notice. The notice must explain (with appropriate use of the applicable 
money amounts) any difference in the amount determined to be due, and 
the amounts received by the hospital during the cost reporting period 
covered by the notice.
    (b) Requirements for intermediary notices. The intermediary must 
include in each notice appropriate references to law, regulations, HCFA 
Rulings, or

[[Page 118]]

program instructions to explain why the intermediary's determination of 
the amount of program reimbursement for the period differs from the 
amount the provider claimed. The notice must also inform the provider of 
its right to an intermediary or Board hearing (see Secs. 405.1809, 
405.1811, 405.1815, 405.1835, and 405.1843) and that the provider must 
request the hearing within 180 days after the date of the notice.
    (c) Use of notice as basis for recoupment of overpayments. The 
intermediary's determination contained in its notice is the basis for 
making the retroactive adjustment (required by Sec. 413.64(f) of this 
chapter) to any program payments made to the provider during the period 
to which the determination applies, including recoupment under 
Sec. 405.373 from ongoing payments to the provider of any overpayments 
to the provider identified in the determination. Recoupment is made 
notwithstanding any request for hearing on the determination the 
provider may make under Sec. 405.1811 or Sec. 405.1835.

[48 FR 39834, Sept. 1, 1983, as amended at 49 FR 322, Jan 3, 1984; 51 FR 
34793, Sept. 30, 1986; 61 FR 63748, Dec. 2, 1996]



Sec. 405.1804  Matters not subject to administrative and judicial review under prospective payment.

    Neither administrative nor judicial review is available for 
controversies about the following matters:
    (a) The determination of the requirement, or the proportional 
amount, of any budget neutrality adjustment in the prospective payment 
rates.
    (b) The establishment of--
    (1) Diagnosis related groups (DRGs);
    (2) The methodology for the classification of inpatient discharges 
within the DRGs; or
    (3) Appropriate weighting factors that reflect the relative hospital 
resources used with respect to discharge within each DRG.

[49 FR 322, Jan. 1, 1984]



Sec. 405.1805  Parties to intermediary determination.

    The parties to the intermediary's determination are the provider and 
any other entity found by the intermediary to be a related organization 
of the provider under Sec. 413.17 of this chapter.

[48 FR 39835, Sept. 1, 1983, as amended at 51 FR 34793, Sept. 30, 1986]



Sec. 405.1807  Effect of intermediary determination.

    The determination shall be final and binding on the party or parties 
to such determination unless:
    (a) An intermediary hearing is requested in accordance with 
Sec. 405.1811 and an intermediary hearing decision rendered in 
accordance with Sec. 405.1831; or
    (b) The intermediary determination is revised in accordance with 
Sec. 405.1885; or
    (c) A Board hearing is requested in accordance with Sec. 405.1835 
and a hearing decision rendered pursuant thereto.



Sec. 405.1809  Intermediary hearing procedures.

    (a) Hearings. Each intermediary must establish and maintain written 
procedures for intermediary hearings, in accordance with the regulations 
in this subpart, for resolving issues that may arise between the 
intermediary and a provider concerning the amount of reasonable cost 
reimbursement, or prospective payment due the provider (except as 
provided in Sec. 405.1804) under the Medicare program. The procedures 
must provide for a hearing on the intermediary determination contained 
in the notice of program reimbursement (Sec. 405.1803), if the provider 
files a timely request for a hearing.
    (b) Amount in controversy. In order for an intermediary to grant a 
hearing, the following dates and amounts in controversy apply:
    (1) For cost reporting periods ending prior to June 30, 1973, the 
amount of program reimbursement in controversy must be at least $1000.
    (2) For cost reporting periods ending on or after June 30, 1973, the 
amount of program reimbursement in controversy must be at least $1000 
but less than $10,000.

[48 FR 39835, Sept. 1, 1983, as amended at 49 FR 323, Jan. 1, 1984]

[[Page 119]]



Sec. 405.1811  Right to intermediary hearing; time, place, form, and content of request for intermediary hearing.

    (a) A provider that has been furnished a notice of amount of program 
reimbursement may request an intermediary hearing if it is dissatisfied 
with the intermediary's determination contained in the notice and the 
amount in controversy requirement described in Sec. 405.1809 is met. The 
request must be in writing and be filed with the intermediary within 180 
calendar days after the date of the notice. (See Sec. 405.1835(c)). No 
other individual, entity, or party has the right to an intermediary 
hearing.
    (b) The request must (1) identify the aspect(s) of the determination 
with which the provider is dissatisfied, and (2) explain why the 
provider believes the determination on these matters is incorrect, and 
(3) be submitted with any documentary evidence the provider considers 
necessary to support its position.
    (c) Following the timely filing of the request for hearing, the 
provider may identify in writing, prior to the onset of the hearing 
proceedings, additional aspects of the determination with which it is 
dissatisfied and furnish any documentary evidence in support thereof. If 
such additional aspects are submitted, the hearing officer may postpone 
the hearing to allow for his examination of such additional aspects.

[39 FR 34515, Sept. 26, 1974. Redesignated at 42 FR 52826, Sept. 30, 
1977, as amended at 48 FR 39835, Sept. 1, 1983]



Sec. 405.1813  Failure to timely request an intermediary hearing.

    If a provider requests an intermediary hearing on an intermediary's 
determination after the time limit prescribed in Sec. 405.1811, the 
designated intermediary hearing officer or panel of hearing officers 
will dismiss the request and furnish the provider a written notice that 
explains the time limitation, except that for good cause shown, the time 
limit prescribed in Sec. 405.1811 may be extended. However, an extension 
may not be granted if the extension request is filed more than 3 years 
after the date of the original notice of the intermediary determination.

[48 FR 39835, Sept. 1, 1983]



Sec. 405.1815  Parties to the intermediary hearing.

    The parties to the intermediary hearing shall be the parties to the 
intermediary determination and any other entity determined by the 
intermediary to be a related organization of such provider. Said parties 
shall be given reasonable notice of the time, date, and place of such 
hearing. Neither the intermediary nor the Health Care Financing 
Administration are parties (see Sec. 405.1819).



Sec. 405.1817  Hearing officer or panel of hearing officers authorized to conduct intermediary hearing; disqualification of officers.

    The intermediary hearing provided for in Sec. 405.1809 shall be 
conducted by a hearing officer or panel of hearing officers designated 
by the intermediary. Such hearing officer or officers shall be persons 
knowledgeable in the field of health care reimbursement. The hearing 
officer or officers shall not have had any direct responsibility for the 
program reimbursement determination with respect to which a request for 
hearing is filed; no hearing officer (or officers) shall conduct a 
hearing in a case in which he is prejudiced or partial with respect to 
any party, or where he has any interest in the matter pending for 
determination before him. Notice of any objection which a party may have 
with respect to a hearing officer shall be presented in writing to such 
officer by the objecting party at the party's earliest opportunity. The 
hearing officer shall consider the objection and shall, at his 
discretion, either proceed in the conduct of the hearing or withdraw. If 
the hearing officer does not withdraw, the objecting party may, after 
the hearing, present his objections to an executive official of the 
intermediary, who shall rule promptly on the objection.



Sec. 405.1819  Conduct of intermediary hearing.

    The hearing shall be open to all parties thereto (see Sec. 405.1815) 
and to representatives of the intermediary and of

[[Page 120]]

the Health Care Financing Administration (see Sec. 405.1815). The 
hearing officer(s) shall inquire fully into all of the matters at issue 
and shall receive into evidence the testimony and any documents which 
are relevant and material to such matters. If the hearing officer(s) 
believes that there is relevant and material evidence available which 
has not been presented at the hearing, he (they) may, at any time prior 
to the mailing of notice of the decision, reopen the hearing record for 
the receipt of such evidence. The order in which the evidence and the 
allegations shall be presented and the conduct of the hearing shall be 
at the discretion of the hearing officer(s).



Sec. 405.1821  Prehearing discovery and other proceedings prior to the intermediary hearing.

    (a) Prehearing discovery shall be permitted upon timely request of 
any party. To be timely, a request for discovery and inspection shall be 
made before the beginning of the hearing. A reasonable time for 
inspection and reproduction of documents shall be provided by order of 
the hearing officer(s).
    (b) If, in the discretion of the hearing officer(s), the purpose of 
defining the issues more clearly would be served, the hearing officer(s) 
may schedule a prehearing conference. For this purpose, a single member 
of a panel of hearing officers, when such is the case, may be appointed 
to act for the panel with respect to prehearing activities.



Sec. 405.1823  Evidence at intermediary hearing.

    Evidence may be received at the intermediary hearing even though 
inadmissible under the rules of evidence applicable to court procedure. 
The hearing officer(s) shall give the parties opportunity for submission 
and consideration of facts and arguments, and during the course of the 
hearing, should in ruling upon admissibility of evidence, exclude 
irrelevant, immaterial, or unduly repetitious evidence. The hearing 
officer(s) shall render a final ruling on the admissibility of evidence.



Sec. 405.1825  Witnesses at intermediary hearing.

    The hearing officer(s) may examine the witnesses and shall allow the 
parties and their representatives to do so. Parties to the proceedings 
may also cross-examine witnesses.



Sec. 405.1827  Record of intermediary hearing.

    A complete recordation of the proceedings at the intermediary 
hearing shall be made and transcribed in all cases. It shall be made 
available to any party upon request. The record will not be closed until 
a decision (see Sec. 405.1831) has been issued.



Sec. 405.1829  Authority of hearing officer(s) at intermediary hearing.

    (a) The hearing officer(s) in exercising his authority must comply 
with all the provisions of title XVIII of the Act and regulations issued 
thereunder, as well as with HCFA Rulings issued under the authority of 
the Administrator of the Health Care Financing Administration (see 42 
CFR 401.108), and with the general instructions issued by the Health 
Care Financing Administration in accordance with the Secretary's 
agreement with the intermediary.
    (b) The determination of a fiscal intermediary that no payment may 
be made under title XVIII of the Act for any expense incurred for items 
and services furnished to an individual because such items and services 
are excluded from coverage pursuant to section 1862 of the Act, 42 
U.S.C. 1395y (see subpart C of this part), shall not be reviewed by the 
hearing officer(s). Such determination shall be reviewed only in 
accordance with the applicable provisions of subparts G and H of this 
part.



Sec. 405.1831  Intermediary hearing decision and notice.

    The hearing officer(s) shall, on a timely basis, render a decision 
in writing based on the evidence in the record; such decision shall 
constitute the final determination of the intermediary. In such 
decision, he will cite applicable law, regulations, HCFA Rulings, and 
general instructions of the Health Care Financing Administration, as 
well as

[[Page 121]]

findings on all the matters in issue at the hearing. A copy of the 
decision will be mailed to all parties to the hearing at their last 
known addresses.



Sec. 405.1833  Effect of intermediary hearing decision.

    The intermediary hearing decision provided for in Sec. 405.1831 
shall be final and binding upon all parties to the hearing unless such 
intermediary determination is revised in accordance with Sec. 405.1885.



Sec. 405.1835  Right to Board hearing.

    (a) Criteria. The provider (but no other individual, entity, or 
party) has a right to a hearing before the Board about any matter 
designated in Sec. 405.1801(a)(1), if:
    (1) An intermediary determination has been made with respect to the 
provider; and
    (2) The provider has filed a written request for a hearing before 
the Board under the provisions described in Sec. 405.1841(a)(1); and
    (3) The amount in controversy (as determined in Sec. 405.1839(a)) is 
$10,000 or more.
    (b) Prospective payment exceptions. Except with respect to matters 
for which administrative or judicial review is not permitted as 
specified in Sec. 405.1804, hospitals that are paid under the 
prospective payment system are entitled to hearings before the Board 
under this section if they otherwise meet the criteria described in 
paragraph (a) of this section.
    (c) Right to hearing based on late intermediary determination about 
reasonable cost. Notwithstanding the provisions of paragraph (a)(1) of 
this section, the provider also has a right to a hearing before the 
Board if an intermediary's determination concerning the amount of 
reasonable cost reimbursement due a provider is not rendered within 12 
months after receipt by the intermediary of a provider's perfected cost 
report or amended cost report (as permitted or as required to furnish 
sufficient data for purposes of making such determination--see 
Sec. 405.1803(a)) provided such delay was not occasioned by the fault of 
the provider.

[48 FR 39835, Sept. 1, 1983]



Sec. 405.1837  Group appeal.

    (a) Criteria for group appeals. Subject to paragraph (b) of this 
section, a group of providers may bring an appeal before the Board but 
only if--
    (1) Each provider in the group is identified as one which would, 
upon the filing of a request for a hearing before the Board, but without 
regard to the $10,000 amount in controversy requirement, be entitled to 
a hearing under Sec. 405.1835;
    (2) The matters at issue involve a common question of fact or of 
interpretation of law, regulations or HCFA Rulings; and
    (3) The amount in controversy is, in the aggregate, $50,000 or more.
    (b) Providers under common ownership or control. Effective April 20, 
1983, any appeal filed by providers that are under common ownership or 
control must be brought by the providers as a group appeal in accordance 
with the provisions of paragraph (a) of this section with respect to any 
matters involving an issue common to the providers and for which the 
amount in controversy is, in the aggregate, $50,000 or more (see 
Sec. 405.1841(a)(2)). A single provider involved in a group appeal that 
also wishes to appeal issues that are not common to the other providers 
in the group must file a separate hearing request (see 
Sec. 405.1841(a)(1)) and must separately meet the requirements in 
Sec. 405.1811 or Sec. 405.1835, as applicable.

[48 FR 39836, Sept. 1, 1983]



Sec. 405.1839  Amount in controversy.

    (a) Single appeals. The $1,000 amount in controversy required under 
Sec. 405.1809 for an intermediary hearing and the $10,000 amount in 
controversy required under Sec. 405.1835 for a Board hearing is, as 
applicable to the matters for which the provider has requested a 
hearing, the combined total of the amounts computed as follows:
    (1) Providers under prospective payment. For providers that are paid 
under the prospective payment system, by deducting--
    (i) The total of the payment due the provider on other than a 
reasonable cost basis under the prospective payment system from the 
total amount

[[Page 122]]

that would be payable after a recomputation that takes into account any 
exclusion, exception, adjustment, or additional payment denied the 
provider under part 412 of this chapter, as applicable;
    (ii) The total of the payment due the provider on a reasonable cost 
basis under the prospective payment system from the total reimbursable 
costs claimed by the provider; and
    (iii) The adjusted total reimbursable costs due the provider on a 
reasonable cost basis under other than the prospective payment system 
from the total reimbursable costs claimed by the provider.
    (2) Providers not under prospective payment. For providers that are 
not paid under the prospective payment system, by deducting the adjusted 
total reimbursable program costs due the provider on a reasonable cost 
basis from the total reimbursable costs claimed by the provider.
    (b) Group appeals. The $50,000 amount in controversy required under 
Sec. 405.1837 for group appeals to the Board is, as applicable to the 
common matters for which the group of providers have requested a 
hearing, the combined total of the amounts computed as follows:
    (1) Providers under prospective payment. For providers that are paid 
under the prospective payment system, by deducting--
    (i) The total of the payment due the providers (in the aggregate) on 
other than a reasonable cost basis under the prospective payment system 
from the total amount that would be payable to the providers (in the 
aggregate) after a recomputation that takes into account any applicable 
exception, exclusion, adjustment, or additional payment denied the 
providers under part 412 of this chapter.
    (ii) The total of the payment due the providers (in the aggregate) 
on a reasonable cost basis under the prospective payment system from the 
total reimbursable costs claimed in the aggregate by the providers; and
    (iii) The adjusted total reimbursable costs due the providers (in 
the aggregate) on a reasonable cost basis under other than the 
prospective payment system from the total reimbursable costs claimed in 
the aggregate by the providers.
    (2) Providers not under prospective payment. For providers that are 
not paid under the prospective payment system, by deducting the adjusted 
total reimbursable program costs due the providers (in the aggregate) on 
a reasonable cost basis from the total reimbursable costs claimed in the 
aggregate by the providers.

[49 FR 323, Jan. 3, 1984]



Sec. 405.1841  Time, place, form, and content of request for Board hearing.

    (a) General requirements. (1) The request for a Board hearing must 
be filed in writing with the Board within 180 days of the date the 
notice of the intermediary's determination was mailed to the provider 
or, where notice of the determination was not timely rendered, within 
180 days after the expiration of the period specified in 
Sec. 405.1835(c). Such request for Board hearing must identify the 
aspects of the determination with which the provider is dissatisfied, 
explain why the provider believes the determination is incorrect in such 
particulars, and be accompanied by any documenting evidence the provider 
considers necessary to support its position. Prior to the commencement 
of the hearing proceedings, the provider may identify in writing 
additional aspects of the intermediary's determination with which it is 
dissatisfied and furnish any documentary evidence in support thereof.
    (2) Effective April 20, 1983, any request for a Board hearing by 
providers that are under common ownership or control (see Sec. 413.17 of 
this chapter) must be brought by the providers as a group appeal (see 
Sec. 405.1837(b)) with respect to any matters at issue involving a 
question of fact or of interpretation of law, regulations, or HCFA 
Rulings common to the providers and for which the amount in controversy 
is $50,000 or more in the aggregate. If a group appeal is filed, the 
provider seeking the appeal must be separately identified in the request 
for hearing, which must be prepared and filed consistently with the 
requirements of paragraph (a)(1) of this section.

[[Page 123]]

    (b) Extension of time limit for good cause. A request for a Board 
hearing filed after the time limit prescribed in paragraph (a) of this 
section shall be dismissed by the Board, except that for good cause 
shown, the time limit may be extended. However, no such extension shall 
be granted by the Board if such request is filed more than 3 years after 
the date the notice of the intermediary's determination is mailed to the 
provider.

[48 FR 39836, Sept. 1, 1983, as amended at 51 FR 34793, Sept. 30, 1986]



Sec. 405.1842  Expediting Board proceedings.

    (a) Basis and purpose. This section implements section 1878(f)(1) of 
the Social Security Act, as amended by section 955 of Public Law 96-499 
(42 U.S.C. 1395oo(f)(1)). The amendment provides an opportunity for 
providers to obtain expedited administrative review when the Board 
determines that it does not have the authority to decide a question of 
law, regulation, or HCFA Ruling relevant to the case (see 
Sec. 405.1867).
    (b) Basic rule. (1) Except as provided in paragraph (b)(4) of this 
section, a provider may submit a written request to the Board, with 
supporting documentation, to determine whether the Board has the 
authority to decide a question of law, regulations, or HCFA Rulings 
relevant to and controlling upon an issue to be reviewed by the Board. 
The Board is required to make an expedited review determination in 
writing, either denying or granting the request, within 30 days after 
the date of receipt of the request, as defined in paragraph (1) of this 
section. The Board may also issue a determination on its own motion that 
it lacks authority to decide a question of law, regulations or HCFA 
Rulings.
    (2) The Board must determine that the provider (including each 
provider in a group appeal) is entitled to a hearing under section 
1878(a) of the Act before making the determination described in 
paragraph (b)(1) of this section. Thus, the provider must file (or have 
already filed) a written request for a Board hearing that meets the 
requirements in Sec. 405.1841. The information and documentation 
required with respect to the filing of a request for a hearing is used 
by the Board to determine jurisdiction under section 1878(a) of the Act.
    (3) A provider's request for an expedited review determination 
cannot be considered to be filed with the Board, nor can the 30-day time 
period during which the Board is required to make an expedited review 
determination begin, until such time as the Board accepts jurisdiction 
of the case.
    (4) Proceedings conducted by the Board under an authority other than 
section 1878(a) of the Act and Secs. 405.1835 through 405.1873 of this 
subpart are not hearings for purposes of this section and are not 
subject to the expedited Board proceedings set forth in this section. 
For example, proceedings concerning reimbursement for capital 
expenditures conducted under section 1122(f) of the Act and 
Sec. 405.1890 of this subpart are not hearings for purposes of this 
section. (Section 1122(f) specifically bars any administrative or 
judicial review.)
    (c) ``Own motion'' review. If the Board is considering issuing a 
determination on its own motion that it lacks the authority to decide a 
question of law, regulations, or HCFA Rulings, it will notify the 
provider and intermediary of its proposed determination and allow them a 
reasonable period of time to file evidence or arguments either to 
support or oppose the proposed determination.
    (d) Provider requests. (1) If a provider seeks an expedited Board 
proceeding, it must--(i) File its appropriately documented request in 
writing with the Board; and
    (ii) Send a copy of the request and documentation simultaneously to 
the intermediary.
    (2) The request to the Board for an expedited review determination 
must--(i) Identify the issues and the controlling law, regulation or 
HCFA Ruling for which the Board is to make a determination;
    (ii) Allege and demonstrate that there are no factual issues in 
dispute;
    (iii) Contain an explanation of why the provider believes the Board 
cannot decide the legal issue or issues that are in dispute; and
    (iv) Include all other information or details that support the 
request.

[[Page 124]]

    (3) If the information in the provider request is insufficient for 
the Board to determine whether it has the authority to decide an issue, 
the Board will request more information from the provider. Such a 
request will affect the 30-day time limit as provided in paragraph (i) 
of this section. If the provider does not send more information or sends 
inadequate information, the Board will determine that it has the 
authority to decide the issue and will begin the regular procedure for a 
hearing.
    (e) Intermediary participation. (1) After receiving a copy of the 
provider's request for an expedited review determination, the 
intermediary may send comments to the Board on the provider's request 
and supporting documentation. The intermediary will send a copy of its 
comments to the provider simultaneously.
    (2) If the intermediary's comments raise questions about the 
provider's request for expedited review, the Board may request 
additional information from the provider as provided in paragraph (d)(3) 
of this section.
    (f) Criteria for a Board determination. The Board will review all 
documentation forwarded by the provider and the intermediary relevant to 
the request for a Board determination concerning the Board's authority 
to decide an issue. In its review, the Board will consider--
    (1) The controlling facts in the case;
    (2) The applicability of law, regulations, or HCFA rulings;
    (3) Whether there are factual issues for the Board to resolve; and
    (4) Whether there are legal issues within the authority of the Board 
to decide.
    (g) Board determination. (1) Within 30 days after the date of 
receipt (as defined in paragraph (i) of this section) of a provider's 
request and all necessary documentation the Board will issue a 
determination concerning its authority to decide the question of law, 
regulations, or HCFA Rulings relevant to the issues identified by the 
provider in its request.
    (2) If there are factual or legal issues in dispute on an issue 
within the authority of the Board to decide, the Board will not make an 
expedited review determination on the particular issue but will proceed 
with a hearing. The Board has the authority to decide when two or more 
issues are sufficiently related to preclude separation for purposes of 
an expedited review determination on one or more of them and a hearing 
on the other or others.
    (3) The Board will promptly notify the provider in writing of its 
determination and will send a copy of the determination to the 
intermediary.
    (4) The Board's determination concerning its authority or its lack 
of a determination is not subject to the Secretary's review under 
Sec. 405.1875.
    (h) Effect of a Board decision. (1) The Board's determination, 
issued on its own motion or at the request of a provider, that it lacks 
authority to decide a question of law, regulations or HCFA Rulings is a 
final decision permitting a provider to seek judicial review with 
respect to the matter or matters in controversy contained in the 
determination, within 60 days of the date of the Board's determination.
    (2) After the Board has determined that it does not have the 
authority to decide an issue, the provider will not be granted a hearing 
on the same issue.
    (3) If the Board fails to issue an expedited review determination 
within 30 days of the date of receipt of a complete request (as 
determined under paragraph (i) of this section), the provider may, 
within 60 days from the end of that period, seek judicial review of the 
matters for which it requested the Board's determination.
    (4) If the Board fails to make an expedited review determination 
within the required 30 days, it will begin regular hearing procedures as 
though it has the authority to decide the issue.
    (5) If the provider seeks judicial review because the Board fails to 
make a determination as provided in paragraph (g)(1) of this section, it 
should notify the Board at the time it files for judicial review. The 
Board will not hold a hearing, even if one has been scheduled, on the 
matter or matters for which the provider is seeking judicial review.
    (6) The Board's determination does not affect the right of the 
provider to a Board hearing for issues for which the

[[Page 125]]

provider did not request expedited review, or for which the Board 
determines it does have the authority to decide, or for which the Board 
did not make a determination and the provider did not request judicial 
review.
    (i) Date of receipt. For purposes of this section, the date of 
receipt of the provider's request is the later of--
    (1) The actual date of receipt by the Board of the information 
required under paragraph (d)(2) of this section, or of additional 
information requested by the Board under paragraph (d)(3) of this 
section, whichever the Board receives later; or
    (2) The date indicated on the Board's written notification to the 
provider that the Board has accepted jurisdiction of the case.
    (j) Examples. Below are examples showing when a provider may expect 
to receive an expedited review determination, in relation to various 
circumstances affecting its request for the determination.
    (1) The provider requests a hearing and expedited review at or about 
the same time. If all information is complete, the Board could send 
notification that it has accepted jurisdiction of the case and the 
expedited review determination simultaneously.
    (2) The provider requests both a hearing and an expedited review 
determination, and supplies complete information. The Board accepts 
jurisdiction but, for example, because of the complexity of the case, 
the Board makes its expedited review determination within 30 days after 
it has accepted jurisdiction.
    (3) The provider requests both a hearing and an expedited review 
determination, but the request for a hearing does not contain enough 
information for the Board to determine jurisdiction. The Board would 
request more information to determine jurisdiction and would make its 
expedited review determination within 30 days after it has accepted 
jurisdiction.
    (4) The provider requests both a hearing and an expedited review 
determination, but does not send enough information for the Board to 
make an expedited review determination. Assuming the Board accepts 
jurisdiction, the Board would request more information about the request 
for expedited review and make its determination within 30 days after it 
receives the additional information.
    (5) The provider requests an expedited review determination after 
the Board has accepted jurisdiction. The Board would make its 
determination within 30 days after receipt of an appropriately 
documented request for an expedited review determination.

[47 FR 31690, July 22, 1982, as amended at 48 FR 22925, May 23, 1983]



Sec. 405.1843  Parties to Board hearing.

    (a) The parties to the Board hearing shall be the provider, the 
intermediary (including the Health Care Financing Administration when 
acting directly as intermediary) that rendered the determination being 
appealed (see Sec. 405.1833), and any other entity found by the 
intermediary to be a related organization of such provider.
    (b) Except as provided in paragraph (a), neither the Secretary nor 
the Health Care Financing Administration may be made a party to the 
hearing. However, the Board may call as a witness any employee or 
officer of the Department of Health and Human Services having personal 
knowledge of the facts and the issues in controversy in a hearing 
pending before the Board and may call as a consultant to the Board in 
connection with any such hearing any individual designated by the 
Secretary for such purpose. (See Sec. 405.1863.)



Sec. 405.1845  Composition of Board.

    (a) The Board will consist of five members appointed by the 
Secretary. All shall be knowledgeable in the field of cost 
reimbursement. At least one shall be a certified public accountant. Two 
Board members shall be representative of providers of services.
    (b) The term of office for Board members shall be 3 years, except 
that initial appointments may be for such shorter terms as the Secretary 
may designate to permit staggered terms of office. No member shall serve 
more than two consecutive 3-year terms of office. The Secretary shall 
have the authority to terminate a Board member's term of office for good 
cause.

[[Page 126]]

    (c) One member of the Board shall be designated by the Secretary as 
Chairman thereof and shall coordinate and direct the administrative 
activities of the Board, and shall have such other authority which may 
be granted to him by the Board.
    (d) A quorum shall be required for the rendering of Board decisions. 
Three members, at least one of whom is representative of providers of 
services, shall be required to constitute a quorum. The Chairman of the 
Board, with approval of the provider, may designate one or more Board 
members to conduct any hearing and to prepare a recommended decision 
(where less than a quorum conducts the hearing). (See Sec. 405.1869.)

[39 FR 34515, Sept. 26, 1974, as amended at 41 FR 52051, Nov. 26, 1976. 
Redesignated at 42 FR 52826, Sept. 30, 1977]



Sec. 405.1847  Disqualification of Board members.

    No Board member shall join in the conduct of a hearing in a case in 
which he is prejudiced or partial with respect to any party or in which 
he has any interest in the matter pending for decision before him. 
Notice of any objection which a party may have with respect to a Board 
member shall be presented in writing to such Board member by the 
objecting party at its earliest opportunity. The Board member shall 
consider the objection and shall, in his discretion, either proceed to 
join in the conduct of the hearing or withdraw. If he does not withdraw, 
the objecting party may petition the Board, presenting its objection and 
reasons therefor, and be entitled to a ruling thereon before the hearing 
can proceed.



Sec. 405.1849  Establishment of time and place of hearing by the Board.

    The Board shall fix the time and place for the hearing and shall 
mail written notice thereof to the parties at their last known 
addresses, not less than 30 days prior to the scheduled time. Either on 
its own motion or for good cause shown by a party, the Board may, as 
appropriate, reschedule, adjourn, postpone, or reopen the hearing, 
provided that reasonable written notice is given to the parties.



Sec. 405.1851  Conduct of Board hearing.

    The Board hearing shall be open to the parties, to representatives 
of the Health Care Financing Administration, and to such other persons 
as the Board deems necessary and proper. The Board shall inquire fully 
into all of the matters at issue and shall receive into evidence the 
testimony of witnesses and any documents which are relevant and material 
to such matters. If the Board believes that there is relevant and 
material evidence available which has not been presented at the hearing, 
it may at any time prior to the mailing of notice of the decision, 
reconvene the hearing for the receipt of such evidence. The order in 
which the evidence and the allegations shall be presented and the 
conduct of the hearing shall be at the discretion of the Board.



Sec. 405.1853  Prehearing discovery and other proceedings prior to the Board hearing.

    (a) Upon notification that a request for Board hearing has been 
filed, the intermediary shall forthwith review the materials submitted 
by the provider in accordance with Sec. 405.1841. Simultaneously, the 
intermediary shall review the information which formed the basis for its 
determination of the amount of program reimbursement. Based on the 
findings of such review, the intermediary shall expeditiously attempt to 
join with the provider in written stipulations setting forth the issues 
that said review has resolved and designating the issues that remain for 
Board resolution. Having obtained such stipulations and being satisfied 
that no further agreements can be negotiated, the intermediary shall 
ensure that all available documentary evidence in support of each 
party's position is part of the record. Such evidence will ordinarily 
include a position paper from the provider, a position paper from the 
intermediary, and any documents which support the issues addressed in 
the stipulations. These materials, in addition to all relevant documents 
which formed the basis for its determination of the amount of program 
reimbursement, shall be forwarded to the Board within 60 days after the 
date of the provider's request for Board review.

[[Page 127]]

    (b) Prehearing discovery shall be permitted upon timely request of a 
party. To be timely, a request for discovery and inspection shall be 
made before the beginning of the hearing. A reasonable time for 
inspection and reproduction of documents shall be provided by order of 
the Board. The Board's order on all discovery matters shall be final.
    (c) If, in the discretion of the Board, the purpose of defining the 
issues more clearly would be served, the Board may schedule a prehearing 
conference. For this purpose, a single member of the Board may be 
appointed to act for the Board with respect to prehearing activities.



Sec. 405.1855  Evidence at Board hearing.

    Evidence may be received at the Board hearing even though 
inadmissible under the rules of evidence applicable to court procedure. 
The Board shall give the parties opportunity for submission and 
consideration of facts and arguments and during the course of the 
hearing should, in ruling upon admissibility of evidence, exclude 
irrelevant, immaterial, or unduly repetitious evidence. The Board shall 
render a final ruling on the admissibility of evidence.



Sec. 405.1857  Subpoenas.

    When reasonably necessary for the full presentation of a case, the 
Board may, either upon its own motion or upon the request of a party, 
issue subpoenas for the attendance and testimony of witnesses and for 
the production of books, records, correspondence, papers, or other 
documents which are relevant and material to any matter in issue at the 
hearing. Parties who desire the issuance of a subpoena shall, not less 
than 10 days prior to the time fixed for the hearing, file with the 
Board a written request therefor, designating the witnesses or documents 
to be produced, and describing the address, or location thereof with 
sufficient particularity to permit such witnesses or documents to be 
found. The request for a subpoena shall state the pertinent facts which 
the party expects to establish by such witnesses or documents and 
whether such facts could be established by other evidence without the 
use of a subpoena. Subpoenas, as provided for above, shall be issued in 
the name of the Board, and the Health Care Financing Administration 
shall assume the cost of the issuance and the fees and mileage of any 
witness so subpoenaed, as provided in section 205(d) of the Act, 42 
U.S.C. 405(d).



Sec. 405.1859  Witnesses.

    Witnesses at the hearing shall testify under oath or affirmation, 
unless excused by the Board for cause. The Board may examine the 
witnesses and shall allow the parties or their representatives to do so. 
Parties to the proceeding may also cross-examine witnesses.



Sec. 405.1861  Oral argument and written allegations.

    The parties, upon their request, shall be allowed a reasonable time 
for the presentation of oral argument or for the filing of briefs or 
other written statements of allegations as to facts or law. Copies of 
any brief or other written statement shall be filed in sufficient number 
that they may be made available to all parties and to the Health Care 
Financing Administration.



Sec. 405.1863  Administrative policy at issue.

    Where a party to the Board hearing puts into issue an administrative 
policy which is interpretative of the law or regulations, the Board will 
promptly notify to the Health Care Financing Administration.



Sec. 405.1865  Record of Board hearing.

    A complete record of the proceedings at the hearing shall be made 
and transcribed in all cases. It shall be made available to the parties 
upon request. The record will not be closed until a decision has been 
issued.



Sec. 405.1867  Sources of Board's authority.

    In exercising its authority to conduct the hearings described 
herein, the Board must comply with all the provisions of title XVIII of 
the Act and regulations issued thereunder, as well as HCFA Rulings 
issued under the authority of the Administrator of the Health Care 
Financing Administration (see Sec. 401.108 of this subchapter). The 
Board

[[Page 128]]

shall afford great weight to interpretive rules, general statements of 
policy, and rules of agency organization, procedure, or practice 
established by HCFA.

[48 FR 22925, May 23, 1983]



Sec. 405.1869  Scope of Board's decision-making authority.

    The Board shall have the power to affirm, modify, or reverse a 
determination of an intermediary with respect to a cost report and to 
make any other modifications on matters covered by such cost report 
(including modifications adverse to the provider or other parties) even 
though such matters were not considered in the intermediary's 
determination. The opinion of the majority of those Board members 
deciding the case will constitute the Board's decision.



Sec. 405.1871  Board hearing decision and notice.

    (a) The Board shall, as soon as practicable after the conclusion of 
its hearing, render a written decision based upon the record made at 
such hearing, the record established in support of the determination of 
the intermediary (see Sec. 405.1803), and such other evidence as may be 
obtained or received by the Board. Such Board decision shall be 
supported by substantial evidence when the record of the Board hearing 
is viewed as a whole and shall cite applicable law, regulations, and 
HCFA Rulings. A copy of the decision shall be mailed to all parties to 
the hearing at their last known addresses and, at the same time, to the 
Administrator and HCFA.
    (b) The decision of the Board provided for in paragraph (a) of this 
section shall be final and binding upon all parties to the hearing 
before the Board unless it is reviewed by the Secretary in accordance 
with Sec. 405.1875, or revised in accordance with Sec. 405.1885.

[39 FR 34515, Sept. 26, 1974, as amended at 41 FR 52051, Nov. 26, 1976. 
Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 48 FR 45773, 
Oct. 7, 1983]



Sec. 405.1873  Board's jurisdiction.

    (a) Board decides jurisdiction. The Board decides questions relating 
to its jurisdiction to grant a hearing, including (1) the timeliness of 
an intermediary determination (see Sec. 405.1835(c)), and (2) the right 
of a provider to a hearing before the Board when the amount in 
controversy is in issue (see Secs. 405.1835(a)(3) and 405.1837).
    (b) Matters not subject to board review. (1) The determination of a 
fiscal intermediary that no payment may be made under title XVIII of the 
Act for any expenses incurred for items and services furnished to an 
individual because such items and services are excluded from coverage 
pursuant to section 1862 of the Act, 42 U.S.C. 1395y (see subpart C of 
this part), may not be reviewed by the Board. (Such determination shall 
be reviewed only in accordance with the applicable provisions of subpart 
G or H of this part.)
    (2) The Board may not review certain matters affecting payments to 
hospitals under the prospective payment system as provided in 
Sec. 405.1804.

[48 FR 39836, Sept. 1, 1983]



Sec. 405.1875  Administrator's review.

    (a) General rule. (1) Except for a Board determination under 
Sec. 405.1842 that it lacks the authority to decide an issue, the 
Administrator, at his or her discretion, may review any final decision 
of the Board, including a decision under Sec. 405.1873 about the Board's 
jurisdiction to grant a hearing. The Administrator may exercise this 
discretion on his or her own motion, in response to a request from a 
party to a Board hearing or in response to a request from HCFA.
    (2) The Office of the Attorney Advisory will examine the Board's 
decisions, the requests made by a party or HCFA and any submission made 
in accordance with the provisions of this section in order to assist the 
Administrator in deciding whether to exercise this review authority.
    (b) Request for review. A party or HCFA requesting the Administrator 
to review a Board decision must file a written request with the 
Administrator within 15 days of the receipt of the Board decision.
    (c) Criteria for deciding whether to review. In deciding whether to 
review a Board decision, either on his or her own motion or in response 
to a request from a party to the hearing or HCFA,

[[Page 129]]

the Administrator will normally consider whether it appears that:
    (1) The Board made an erroneous interpretation of law, regulation or 
HCFA Ruling;
    (2) The Board's decision is not supported by substantial evidence; 
or
    (3) The case presents a significant policy issue having a basis in 
law and regulations, and review is likely to lead to the issuance of a 
HCFA Ruling or other directive needed to clarify a statutory or 
regulatory provision;
    (4) The Board has incorrectly assumed or denied jurisdiction or 
extended its authority to a degree not provided for by statute, 
regulation or HCFA Ruling; and
    (5) The decision of the Board requires clarification, amplification, 
or an alternative legal basis for the decision.
    (d) Decision to review. (1) Whether or not a party or HCFA has 
requested review, the Administrator will promptly notify the parties and 
HCFA whether he or she has decided to review a decision of the Board 
and, if so, will indicate the particular issues he or she will consider.
    (2) The Administrator may decline to review a case or any issue in a 
case even if a party has filed a written request for review under 
paragraph (b) of this section.
    (e) Written submissions. (1) Within 15 days of receipt of a notice 
that the Administrator has decided to review a Board decision, a party 
or HCFA may submit to the Administrator, in writing:
    (i) Proposed findings and conclusions;
    (ii) Supporting views or exceptions to the Board decision;
    (iii) Supporting reasons for the exceptions and proposed findings; 
and
    (iv) A rebuttal of the other party's request for review or other 
submissions already filed with the Administrator.
    (2) These submissions shall be limited to issues the Administrator 
has decided to review and confined to the record of the Board hearing.
    (3) A party or HCFA, within 15 days of receipt of a notice that the 
Administrator has decided to review a decision, may also request that 
the decision be remanded and state reasons for doing so. Reasons for a 
request to remand may include new, substantial evidence concerning--
    (i) Issues presented to the Board; and
    (ii) New issues that have arisen since the case was presented to the 
Board.
    (4) A copy of any written submission made under this paragraph shall 
be sent simultaneously to each other party to the Board hearing and to 
HCFA, if HCFA has previously--
    (i) Requested that the Administrator review a Board decision or 
filed a written submission in response to a party's request for review.
    (ii) Responded to a party's request for review; or
    (iii) Submitted material after the Administrator has announced that 
he or she will review a Board decision.
    (f) Ex parte communications prohibited. All communications from any 
of the parties or HCFA about a Board decision being reviewed by the 
Administrator must be in writing and must contain a certification that 
copies have been served on the parties and HCFA, as appropriate. The 
Administrator will not consider any communication that does not meet 
these requirements or is not submitted within the required time limits.
    (g) Administrator's decision. (1) If the Administrator has notified 
the parties and HCFA that he or she has decided to review a Board 
decision, the Administrator will affirm, reverse, modify or remand the 
case.
    (2) The Administrator will make this decision within 60 days after 
the provider received notification of the Board decision and will 
promptly mail a copy of the decision to each party and to HCFA.
    (3) Any decision other than to remand will be confined to--
    (i) The record of the Board, as forwarded by the Board;
    (ii) Any materials submitted under paragraphs (b) or (e) of this 
section; and
    (iii) Generally known facts that are not subject to reasonable 
dispute.
    (4) The Administrator may rely on prior decisions of the Board, the 
Administrator and the courts, and other applicable law, whether or not 
cited by the parties and HCFA.

[[Page 130]]

    (h) Remand. (1) A remand to the Board by the Administrator vacates 
the Board's decision.
    (2) The Administrator may direct the Board to take further action 
with respect to the development of additional facts or new issues, or to 
consider the applicability of laws or regulations other than those 
considered by the Board. The following are not acceptable bases for 
remand--
    (i) Presentation of evidence existing at the time of the Board 
hearing that was known or reasonably could have been known;
    (ii) Introduction of a favorable court case that was either not 
available in print at the time of the Board hearing or was decided after 
the Board hearing;
    (iii) Change of a party's representation before the Board;
    (iv) Presentation of an alternative legal basis concerning an issue 
in dispute; or
    (v) Attempted retraction of a waiver of a right made before or at 
the Board hearing.
    (3) After remand, the Board will take the action requested in the 
remand action and issue a new decision.
    (4) The new decision will be final unless the Administrator 
reverses, affirms, modifies, or again remands the decision in accordance 
with the provisions of the section.

[48 FR 45773, Oct. 7, 1983]



Sec. 405.1877  Judicial review.

    (a) General rule. Section 1878(f) of the Act permits a provider to 
obtain judicial review of a final decision of the Board, or of a 
reversal, affirmation, or modification by the Administrator of a Board 
decision, by filing a civil action pursuant to the Federal Rules of 
Civil Procedure within 60 days of the date on which the provider 
received notice of--
    (1) A final decision by the Board; or
    (2) Any reversal, affirmance, or modification by the Administrator.

The Board's decision is not final if the Administrator reverses, affirms 
or modifies the decision within 60 days of the date on which the 
provider received notice of the decision.
    (b) Administrator declines to review a Board decision. If the 
Administrator declines to review a Board decision, the provider must 
file its appeal within 60 days of receipt of the decision of the Board.
    (c) Administrator does not act after reviewing a Board decision. If 
the Administrator notifies the parties that he or she has decided to 
review a Board decision and then does not make a decision within the 60 
days allotted for his or her review, this subsequent inaction 
constitutes an affirmance allowing a provider an additional 60 days in 
which to file for judicial review, beginning with the date the 
Administrator's time expires for taking action under 
Sec. 405.1875(g)(2).
    (d) Matters not subject to judicial review. Certain matters 
affecting payments to hospital under the prospective payment system are 
not subject to judicial review, as provided in section 1886(d)(7) of the 
Act and Sec. 405.1804.
    (e) Group appeals. Any action under this section by providers that 
are under common ownership or control (see Sec. 413.17 of this chapter) 
must be brought by the providers as a group with respect to any matter 
involving an issue common to the providers.
    (f) Venue for appeals. An action for judicial review must be brought 
in the District Court of the United States for the judicial district in 
which the provider is located (or, effective April 20, 1983, in an 
action brought jointly by several providers, the judicial district in 
which the greatest number of such providers are located) or in the 
District Court for the District of Columbia. Effective April 20, 1983, 
any action for judicial review by providers under common ownership or 
control (Sec. 413.17 of this chapter), must be brought by such providers 
as a group with respect to any matter involving an issue common to the 
providers.
    (g) Service of process. Process must be served as described under 45 
CFR part 4.

[48 FR 39836, Sept. 1, 1983, as amended at 48 FR 45774, Oct. 7, 1983; 51 
FR 34793, Sept. 30, 1986]



Sec. 405.1881  Appointment of representative.

    A provider or other party may be represented by legal counsel or any 
other

[[Page 131]]

person it appoints to act as its representative at the proceedings, 
conducted in accordance with Secs. 405.1819 and 405.1851.



Sec. 405.1883  Authority of representative.

    A representative appointed by a provider or other party may accept 
or give on behalf of the provider or other party any request or notice 
relative to any proceeding before a hearing officer or the Board. A 
representative shall be entitled to present evidence and allegations as 
to facts and law in any proceeding affecting the party he represents and 
to obtain information with respect to a request for an intermediary 
hearing or a Board hearing made in accordance with Secs. 405.1811, 
405.1835, or 405.1837 to the same extent as the party he represents. 
Notice to a provider or other party of any action, determination, or 
decision, or a request for the production of evidence by a hearing 
officer or the Board sent to the representative of the provider or other 
party shall have the same force and effect as if it had been sent to the 
provider or other party.



Sec. 405.1885  Reopening a determination or decision.

    (a) A determination of an intermediary, a decision by a hearing 
officer or panel of hearing officers, a decision by the Board, or a 
decision of the Secretary may be reopened with respect to findings on 
matters at issue in such determination or decision, by such intermediary 
officer or panel of hearing officers, Board, or Secretary, as the case 
may be, either on motion of such intermediary officer or panel of 
hearing officers, Board, or Secretary, or on the motion of the provider 
affected by such determination or decision to revise any matter in issue 
at any such proceedings. Any such request to reopen must be made within 
3 years of the date of the notice of the intermediary or Board hearing 
decision, or where there has been no such decision, any such request to 
reopen must be made within 3 years of the date of notice of the 
intermediary determination. No such determination or decision may be 
reopened after such 3-year period except as provided in paragraphs (d) 
and (e) of this section.
    (b) A determination or a hearing decision rendered by the 
intermediary shall be reopened and revised by the intermediary if, 
within the aforementioned 3-year period, the Health Care Financing 
Administration notifies the intermediary that such determination or 
decision is inconsistent with the applicable law, regulations, or 
general instructions issued by the Health Care Financing Administration 
in accordance with the Secretary's agreement with the intermediary.
    (c) Jurisdiction for reopening a determination or decision rests 
exclusively with that administrative body that rendered the last 
determination or decision.
    (d) Notwithstanding the provisions of paragraph (a) of this section, 
an intermediary determination or hearing decision, a decision of the 
Board, or a decision of the Secretary shall be reopened and revised at 
any time if it is established that such determination or decision was 
procured by fraud or similar fault of any party to the determination or 
decision.
    (e) Paragraphs (a) and (b) of this section apply to determinations 
on cost reporting periods ending on or after December 31, 1971. (See 
Sec. 405.1801(c).) However, the 3-year period described shall also apply 
to determinations with respect to cost reporting periods ending prior to 
December 31, 1971, but only if the reopening action was undertaken after 
May 27, 1972 (the effective date of regulations which, prior to the 
publication of this subpart R, governed the reopening of such 
determinations).



Sec. 405.1887  Notice of reopening.

    (a) All parties to any reopening described above shall be given 
written notice of the reopening. When such reopening results in any 
revision in the prior decision notice of said revision or revisions will 
be mailed to the parties with a complete explanation of the basis for 
the revision or revisions. Notices of reopenings by the Board shall also 
be sent to the Secretary.
    (b) In any such reopening, the parties to the prior decision shall 
be allowed a reasonable period of time in which to present any 
additional evidence or argument in support of their position.

[[Page 132]]



Sec. 405.1889  Effect of a revision.

    Where a revision is made in a determination or decision on the 
amount of program reimbursement after such determination or decision has 
been reopened as provided in Sec. 405.1885, such revision shall be 
considered a separate and distinct determination or decision to which 
the provisions of Secs. 405.1811, 405.1835, 405.1875 and 405.1877 are 
applicable. (See Sec. 405.1801(c) for applicable effective dates.)

Subparts S-T--[Reserved]



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

    Authority: Secs. 1102, 1138, 1861, 1862(a), 1871, 1874, and 1881 of 
the Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x, 1395y(a), 
1395hh, 1395kk, and 1395rr), unless otherwise noted.

    Source: 41 FR 22511, June 3, 1976, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977.



Sec. 405.2100  Scope of subpart.

    (a) The regulations in this subpart prescribe the role which End-
Stage Renal Disease (ESRD) networks have in the ESRD program, establish 
the mechanism by which minimal utilization rates are promulgated and 
applied, under section 1881(b)(1) of the Act, and describe the health 
and safety requirements that facilities furnishing ESRD care to 
beneficiaries must meet. These regulations further prescribe the role of 
ESRD networks in meeting the requirements of section 1881(c) of the Act.
    (b) The general objectives of the ESRD program are contained in 
Sec. 405.2101, and general definitions are contained in Sec. 405.2102. 
The provisions of Secs. 405.2110, 405.2112 and 405.2113 discuss the 
establishment and activities of ESRD networks, network organizations and 
membership requirements and restrictions for members of the medical 
review boards. Sections 405.2120 through 405.2124 discuss the 
establishment of minimal utilization rates and the requirements for 
approval of facilities with respect to such rates. Sections 405.2130 
through 405.2140 discuss general requirements for, and description of, 
all facilities furnishing ESRD services. Sections 405.2160 through 
405.2164 discuss specific requirements for facilities which furnish ESRD 
dialysis services. Sections 405.2170 and 405.2171 discuss specific 
requirements for facilities which furnish ESRD transplantation services.

[51 FR 30361, Aug. 26, 1986]



Sec. 405.2101  Objectives of the end-stage renal disease (ESRD) program.

    The objectives of the end-stage renal disease program are:
    (a) To assist beneficiaries who have been diagnosed as having end-
stage renal disease (ESRD) to receive the care they need;
    (b) To encourage proper distribution and effective utlization of 
ESRD treatment resources while maintaining or improving the quality of 
care;
    (c) To provide the flexibility necessary for the efficient delivery 
of appropriate care by physicians and facilities; and
    (d) To encourage self-dialysis or transplantation for the maximum 
practical number of patients who are medically, socially, and 
psychologically suitable candidates for such treatment.

[43 FR 48950, Oct. 19, 1979]



Sec. 405.2102  Definitions.

    As used in this subpart, the following definitions apply:
    Agreement. A written document executed between an ESRD facility and 
another facility in which the other facility agrees to assume 
responsibility for furnishing specified services to patients and for 
obtaining reimbursement for those services.
    Arrangement. A written document executed between an ESRD facility 
and another facility in which the other facility agrees to furnish 
specified services to patients but the ESRD facility retains 
responsibility for those services and for obtaining reimbursement for 
them.
    Dialysis. A process by which dissolved substances are removed from a 
patient's body by diffusion from one fluid compartment to another across 
a semipermeable membrane. The two types of dialysis that are currently 
in

[[Page 133]]

common use are hemodialysis and peritoneal dialysis.
    End-Stage Renal Disease (ESRD). That stage of renal impairment that 
appears irreversible and permanent, and requires a regular course of 
dialysis or kidney transplantation to maintain life.
    ESRD facility. A facility which is approved to furnish at least one 
specific ESRD service (see definition of ``ESRD service''). Such 
facilities are:
    (a) Renal Transplantation Center. A hospital unit which is approved 
to furnish directly transplantation and other medical and surgical 
specialty services required for the care of the ESRD transplant 
patients, including inpatient dialysis furnished directly or under 
arrangement. A Renal Transplantation Center may also be a Renal Dialysis 
Center.
    (b) Renal dialysis center. A hospital unit which is approved to 
furnish the full spectrum of diagnostic, therapeutic, and rehabilitative 
services required for the care of ESRD dialysis patients (including 
inpatient dialysis furnished directly or under arrangement). A hospital 
need not provide renal transplantation to qualify as a renal dialysis 
center.
    (c) Renal dialysis facility. A unit which is approved to furnish 
dialysis service(s) directly to ESRD patients.
    (d) Self-dialysis unit. A unit that is part of an approved renal 
transplantation center, renal dialysis center, or renal dialysis 
facility, and furnishes self-dialysis services.
    (e) Special purpose renal dialysis facility. A renal dialysis 
facility which is approved under Sec. 405.2164 to furnish dialysis at 
special locations on a short-term basis to a group of dialysis patients 
otherwise unable to obtain treatment in the geographical area. The 
special locations must be either special rehabilitative (including 
vacation) locations serving ESRD patients temporarily residing there, or 
locations in need of ESRD facilities under emergency circumstances.
    ESRD service. The type of care or services furnished to an ESRD 
patient. Such types of care are:
    (a) Transplantation service. A process by which (1) a kidney is 
excised from a live or cadaveric donor, (2) that kidney is implanted in 
an ESRD patient, and (3) supportive care is furnished to the living 
donor and to the recipient following implantation.
    (b) Dialysis service--(1) Inpatient dialysis. Dialysis which, 
because of medical necessity, is furnished to an ESRD patient on a 
temporary inpatient basis in a hospital;
    (2) Outpatient dialysis. Dialysis furnished on an outpatient basis 
at a renal dialysis center or facility. Outpatient dialysis includes:
    (i) Staff-assisted dialysis. Dialysis performed by the staff of the 
center or facility.
    (ii) Self-dialysis. Dialysis performed, with little or no 
professional assistance, by an ESRD patient who has completed an 
appropriate course of training.
    (3) Home dialysis. Dialysis performed by an appropriately trained 
patient at home.
    (c) Self-dialysis and home dialysis training. A program that trains 
ESRD patients to perform self-dialysis or home dialysis with little or 
no professional assistance, and trains other individuals to assist 
patients in performing self-dialysis or home dialysis.
    Furnishes directly. The ESRD facility provides the service through 
its own staff and employees, or through individuals who are under direct 
contract to furnish such services personally for the facility (i.e., not 
through ``agreements'' or ``arrangements'').
    Furnishes on the premises. The ESRD facility furnishes services on 
its main premises; or on its other premises that are (a) contiguous with 
or in immediate proximity to the main premises, and under the direction 
of the same professional staff and governing body as the main premises, 
or (b) approved on a time-limited basis as a special purpose renal 
dialysis facility.
    Histocompatibility testing. Laboratory test procedures which 
determine compatibility between a potential organ donor and a potential 
organ transplant recipient.
    Medical care criteria. Predetermined elements against which aspects 
of the quality of a medical service may be

[[Page 134]]

compared. They are developed by professionals relying on professional 
expertise and on the professional literature.
    Medical care norms. Numerical or statistical measures of usual 
observed performance. Norms are derived from aggregate information 
related to the health care provided to a large number of patients over a 
period of time.
    Medical care standards. Professionally developed expressions of the 
range of acceptable variation from a norm or criterion.
    Medical care evaluation study (MCE). Review of health care services, 
usually performed retrospectively, in which an indepth assessment of the 
quality and/or utilization of such services is made.
    Network, ESRD. All Medicare-approved ESRD facilities in a designated 
geographic area specified by HCFA.
    Network organization. The administrative governing body to the 
network and liaison to the Federal government.
    Organ procurement. The process of acquiring donor kidneys. (See 
definition of Organ procurement organization in Sec. 485.302 of this 
chapter.)
    Qualified personnel. Personnel that meet the requirements specified 
in this paragraph.
    (a) Chief executive officer. A person who:
    (1) Holds at least a baccalaureate degree or its equivalent and has 
at least 1 year of experience in an ESRD unit; or
    (2) Is a registered nurse or physician director as defined in this 
definition; or
    (3) As of September 1, 1976, has demonstrated capability by acting 
for at least 2 years as a chief executive officer in a dialysis unit or 
transplantation program.
    (b) Dietitian. A person who:
    (1) Is eligible for registration by the American Dietetic 
Association under its requirements in effect on June 3, 1976, and has at 
least 1 year of experience in clinical nutrition; or
    (2) Has a baccalaureate or advanced degree with major studies in 
food and nutrition or dietetics, and has at least 1 year of experience 
in clinical nutrition.
    (c) Medical record practitioner. A person who:
    (1) Has graduated from a program for Medical Record Administrators 
accredited by the Council on Medical Education of the American Medical 
Association and the American Medical Record Association, and is eligible 
for certification as a Registered Record Administrator (RRA) by the 
American Medical Record Association under its requirements in effect on 
June 3, 1976.
    (2) Has graduated from a program for Medical Record Technicians 
approved jointly by the Council on Medical Education of the American 
Medical Association and the American Medical Record Association, and is 
eligible for certification as an Accredited Record Technician (ART) by 
the American Medical Record Association under its requirements in effect 
June 3, 1976, or
    (3) Has successfully completed and received a satisfactory grade in 
the American Medical Record Association's Correspondence Course for 
Medical Record Personnel approved by the Accrediting Commission of the 
National Home Study Council, and is eligible for certification as an 
Accredited Record Technician by the American Medical Record Association 
under its requirements in effect June 3, 1976.
    (d) Nurse responsible for nursing service. A person who is licensed 
as a registered nurse by the State in which practicing, and (1) has at 
least 12 months of experience in clinical nursing, and an additional 6 
months of experience in nursing care of the patient with permanent 
kidney failure or undergoing kidney transplantation, including training 
in and experience with the dialysis process; or
    (2) Has 18 months of experience in nursing care of the patient on 
maintenance dialysis, or in nursing care of the patient with a kidney 
transplant, including training in and experience with the dialysis 
process;
    (3) If the nurse responsible for nursing service is in charge of 
self-care dialysis training, at least 3 months of the total required 
ESRD experience is in training patients in self-care.
    (e) Physician-director. A physician who:
    (1) Is board eligible or board certified in internal medicine or 
pediatrics by a professional board, and has had at least 12 months of 
experience or training in

[[Page 135]]

the care of patients at ESRD facilities; or
    (2) During the 5-year period prior to September 1, 1976, served for 
at least 12 months as director of a dialysis or transplantation program;
    (3) In those areas where a physician who meets the definition in 
paragraph (1) or (2) of this definition is not available to direct a 
participating dialysis facility, another physician may direct the 
facility, subject to the approval of the Secretary.
    (f) Social worker. A person who is licensed, if applicable, by the 
State in which practicing, and
    (1) Has completed a course of study with specialization in clinical 
practice at, and holds a masters degree from, a graduate school of 
social work accredited by the Council on Social Work Education; or
    (2) Has served for 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 paragraph (f)(1) of this definition.
    (g) Transplantation surgeon. A person who:
    (1) Is board eligible or board certified in general surgery or 
urology by a professional board; and
    (2) Has at least 12 months training or experience in the performance 
of renal transplantation and the care of patients with renal 
transplants.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48950, Oct. 19, 1978; 51 FR 30361, Aug. 26, 1986; 53 
FR 6547, Mar. 1, 1988; 55 FR 9575, Mar. 14, 1990]



Sec. 405.2110  Designation of ESRD networks.

    HCFA designated ESRD networks in which the approved ESRD facilities 
collectively provide the necessary care for ESRD patients.
    (a) Effect on patient choice of facility. The designation of 
networks does not require an ESRD patient to seek care only through the 
facilities in the designated network where the patient resides, nor does 
the designation of networks limit patient choice of physicians or 
facilities, or preclude patient referral by physicians to a facility in 
another designated network.
    (b) Redesignation of networks. HCFA will redesignate networks, as 
needed, to ensure that the designations are consistent with ESRD program 
experience, consistent with ESRD program objectives specified in 
Sec. 405.2101, and compatible with efficient program administration.

[51 FR 30361, Aug. 26, 1986]



Sec. 405.2111  [Reserved]



Sec. 405.2112  ESRD network organizations.

    HCFA will designate an administrative governing body (network 
organization) for each network. The functions of a network organization 
include but are not limited to the following:
    (a) Developing network goals for placing patients in settings for 
self-care and transplantation.
    (b) Encouraging the use of medically appropriate treatment settings 
most compatible with patient rehabilitation and the participation of 
patients, providers of services, and renal disease facilities in 
vocational rehabilitation programs.
    (c) Developing criteria and standards relating to the quality and 
appropriateness of patient care and, with respect to working with 
patients, facilities, and providers of services, for encouraging 
participation in vocational rehabilitation programs.
    (d) Evaluating the procedures used by facilities in the network in 
assessing patients for placement in appropriate treatment modalities.
    (e) Making recommendations to member facilities as needed to achieve 
network goals.
    (f) On or before July 1 of each year, submitting to HCFA an annual 
report that contains the following information:
    (1) A statement of the network goals.
    (2) The comparative performance of facilities regarding the 
placement of patients in appropriate settings for--
    (i) Self-care;
    (ii) Transplants; and
    (iii) Vocational rehabilitation programs.
    (3) Identification of those facilities that consistently fail to 
cooperate with

[[Page 136]]

the goals specified under paragraph (f)(1) of this section or to follow 
the recommendations of the medical review board.
    (4) Identification of facilities and providers that are not 
providing appropriate medical care.
    (5) Recommendations with respect to the need for additional or 
alternative services in the network including self-dialysis training, 
transplantation and organ procurement.
    (g) Evaluating and resolving patient grievances.
    (h) Appointing a network council and a medical review board (each 
including at least one patient representative) and supporting and 
coordinating the activities of each.
    (i) Conducting on-site reviews of facilities and providers as 
necessary, as determined by the medical review board or HCFA, using 
standards of care as specified under paragraph (c) of this section.
    (j) Collecting, validating, and analyzing such data as necessary to 
prepare the reports required under paragraph (f) of this section and the 
Secretary's report to Congress on the ESRD program and to assure the 
maintenance of the registry established under section 1881(c)(7) of the 
Act.

[53 FR 1620, Jan. 21, 1988]



Sec. 405.2113  Medical review board.

    (a) General. The medical review board must be composed of 
physicians, nurses, and social workers engaged in treatment relating to 
ESRD and qualified to evaluate the quality and appropriateness of care 
delivered to ESRD patients, and at least one patient representative.
    (b) Restrictions on medical review board members. (1) A medical 
review board member must not review or provide advice with respect to 
any case in which he or she has, or had, any professional involvement, 
received reimbursement or supplied goods.
    (2) A medical review board member must not review the ESRD services 
of a facility in which he or she has a direct or indirect financial 
interest (as described in section 1126(a)(1) of the Act).

[51 FR 30361, Aug. 26, 1986, as amended at 53 FR 1620, Jan. 21, 1988]



Sec. 405.2114  [Reserved]



Sec. 405.2120  Minimum utilization rates: general.

    Section 1881(b)(1) of the Social Security Act (42 U.S.C. 
1395rr(b)(1)) authorizes the Secretary to limit payment for ESRD care to 
those facilities that meet the requirements that the Secretary may 
prescribe, including minimum utilization rates for covered 
transplantations. The minimum utilization rates, which are explained and 
specified in Secs. 405.2121 through 405.2130, may be changed from time 
to time in accordance with program experience. Changes will be published 
as amendments to these regulations.

[55 FR 23440, June 8, 1990]



Sec. 405.2121  Basis for determining minimum utilization rates.

    In developing minimum utilization rates, the Secretary takes into 
account the performance of ESRD facilities, the availability of care, 
the quality of care, and the efficient utilization of equipment and 
personnel, based on the following evidence:
    (a) Information on the geographic distribution of ESRD patients and 
facilities;
    (b) Information on quality of care; and
    (c) Information on operational and management efficiency.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept 30, 1977, 
as amended at 51 FR 30362, Aug. 26, 1986; 55 FR 23440, June 8, 1990]



Sec. 405.2122  Types and duration of classification according to utilization rates.

    A renal transplantation center that meets all the other conditions 
for coverage of ESRD services will be classified according to its 
utilization rate(s) as follows: Unconditional status, conditional 
status, exception status, or not eligible for reimbursement for that 
ESRD service. Such classification will be based on previously reported 
utilization data (see Sec. 405.2124, except as specified in paragraph 
(a) of this section),

[[Page 137]]

and will be effective until notification of subsequent classification 
occurs. (See Sec. 405.2123 for reporting requirements; Sec. 405.2124 for 
method of calculating rates: Sec. 405.2130 for specific standards.)
    (a) Initial classification. (1) A renal transplantation center that 
has not previously participated in the ESRD program will be granted 
conditional status if it submits a written plan, detailing how it will 
achieve the utilization rates for conditional status by the end of the 
second calendar year of its operation under the ESRD program, and the 
rates required for unconditional status by the end of its fourth 
calendar year of operation.
    (2) The renal transplantation center's performance will be evaluated 
at the end of the first calendar year to ascertain whether it is 
properly implementing the plan.
    (b) Exception status. (1) A renal transplantation center that does 
not meet the minimum utilization rate for unconditional or conditional 
status may be approved by the Secretary for a time limited exception 
status if:
    (i) It meets all other conditions for coverage under this subpart;
    (ii) It is unable to meet the minimum utilization rate because it 
lacks a sufficient number of patients and is located in an area without 
a sufficient population base to support a center or facility which would 
meet the rate; and
    (iii) Its absence would adversely affect the achievement of ESRD 
program objectives.
    (2) A hospital that furnishes renal transplantation services 
primarily to pediatric patients and is approved as a renal dialysis 
center under this subpart, but does not meet the utilization standards 
prescribed in Sec. 405.2130(a), may be approved by the Secretary for a 
time limited exception status if:
    (i) It meets all other conditions for coverage as a renal 
transplantation center;
    (ii) The surgery is performed under the direct supervision of a 
qualified transplantation surgeon (Sec. 405.2102) who is also performing 
renal transplantation surgery at an approved renal transplantation 
center that is primarily oriented to adult nephrology;
    (iii) It has an agreement, with the other hospital serviced by the 
surgeon, for sharing limited resources that are needed for kidney 
transplantation; and
    (iv) There are pediatric patients who need the surgery and who 
cannot obtain it from any other hospital located within a reasonable 
distance.

[43 FR 48951, Oct. 19, 1978, as amended at 45 FR 58124, Sept. 2, 1980; 
51 FR 30362, Aug. 26, 1986; 55 FR 23440, June 8, 1990]



Sec. 405.2123  Reporting of utilization rates for classification.

    Each hospital furnishing renal transplantation services must submit 
an annual report to HCFA on its utilization rates. The report must 
include both the number of transplants performed during the most recent 
year of operation and the number performed during each of the preceding 
2 calendar years.

[55 FR 23441, June 8, 1990]



Sec. 405.2124  Calculation of utilization rates for comparison with minimal utilization rate(s) and notification of status.

    For purposes of classification the Secretary will use either the 
utilization rate for the preceding 12 months or the average utilization 
rate of the preceding 2 calendar years, whichever is higher. The 
Secretary will inform each ESRD facility and the network coordinating 
council of the network area in which the ESRD facility is located of the 
results of this classification.



Sec. 405.2130  Condition: Minimum utilization rates.

    Unless a renal transplantation center is granted an exception under 
Sec. 405.2122(b), the center must meet the following minimum utilization 
rate(s) for unconditional or conditional status:
    (a) Unconditional status: 15 or more transplants performed annually.
    (b) Conditional status: 7 to 14 transplants performed annually.

[55 FR 23441, June 8, 1990]



Sec. 405.2131  Condition: Provider status: Renal transplantation center or renal dialysis center.

    A renal transplantation center or a renal dialysis center 
(Sec. 405.2102(e) (1) or

[[Page 138]]

(2)) operated by a hospital may qualify for approval and be reimbursed 
under the ESRD program only if the hospital is otherwise an approved 
provider in the Medicare program.



Sec. 405.2132  [Reserved]



Sec. 405.2133  Condition: Furnishing data and information for ESRD program administration.

    The ESRD facility, laboratory performing histocompatibility testing, 
and organ procurement organization furnishes data and information in the 
manner and at the intervals specified by the Secretary, pertaining to 
its ESRD patient care activities and costs, for inclusion in a national 
ESRD medical information system and in compilations relevant to program 
administration, including claims processing and reimbursement. Such 
information is treated as confidential when it pertains to individual 
patients and is not disclosed except as authorized by Department 
regulations on confidentiality and disclosure (see 45 CFR parts 5, 5b, 
and part 401 of this chapter).

[53 FR 6548, Mar. 1, 1988]



Sec. 405.2134  Condition: Participation in network activities.

    Each facility must participate in network activities and pursue 
network goals.

[51 FR 30362, Aug. 26, 1986]



Sec. 405.2135  Condition: Compliance with Federal, State and local laws and regulations.

    The ESRD facility is in compliance with applicable Federal, State 
and local laws, and regulations.
    (a) Standard: licensure. Where State or applicable local law 
provides for the licensing of ESRD facilities, the facility is:
    (1) Licensed pursuant to such law; or
    (2) Approved by the agency of such State or locality responsible for 
such licensing as meeting the standards established for such licensing.
    (b) Standard: licensure or registration of personnel. Each staff 
member is currently licensed or registered in accordance with applicable 
law.
    (c) Standard: conformity with other laws. The facility is in 
conformity with applicable laws and regulations pertaining to fire 
safety, equipment, and other relevant health and safety requirements.



Sec. 405.2136  Condition: Governing body and management.

    The ESRD facility is under the control of an identifiable governing 
body, or designated person(s) so functioning, 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. The governing body receives and acts 
upon recommendations from the network organization. The governing body 
appoints a chief executive officer who is responsible for the overall 
management of the facility.
    (a) Standard: disclosure of ownership. The ESRD facility supplies 
full and complete information to the State survey agency 
(Sec. 405.1902(a)) as to the identity of:
    (1) Each person who has any direct or indirect ownership interest of 
10 per centum or more in the facility, or who is the owner (in whole or 
in part) of any mortgage, deed of trust, note, or other obligation 
secured (in whole or in part) by the facility or any of the property or 
assets of the facility;
    (2) Each officer and director of the corporation, if the facility is 
organized as a corporation; and
    (3) Each partner, if the facility is organized as a partnership; and 
promptly reports to the State survey agency any changes which would 
affect the current accuracy of the information so required to be 
supplied.
    (b) Standard: Operational objectives. The operational objectives of 
the ESRD facility, including the services that it provides, are 
established by the governing body and delineated in writing. The 
governing body adopts effective administrative rules and regulations 
that are designed to safeguard the health and safety of patients and to 
govern the general operations of the facility, in accordance with legal 
requirements. Such rules and regulations

[[Page 139]]

are in writing and dated. The governing body ensures that they are 
operational, and that they are reviewed at least annually and revised as 
necessary. If the ESRD facility is engaged in the practice of 
hemodialyzer reuse, the governing body ensures that there are written 
policies and procedures with respect to reuse, to assure that 
recommended standards and conditions are being followed, and requires 
that patients be informed of the policies and procedures.
    (1) The objectives of the facility are formulated in writing and 
clearly stated in documents appropriate for distribution to patients, 
facility personnel, and the public.
    (2) A description of the services provided by the facility, together 
with a categorical listing of the types of diagnostic and therapeutic 
procedures that may be performed, is readily available upon request to 
all concerned.
    (3) Admission criteria that insure equitable access to services are 
adopted by the facility and are readily available to the public. Access 
to the self-dialysis unit is available only to patients for whom the 
facility maintains patient care plans (see Sec. 405.2137).
    (4) The operational objectives and administrative rules and 
regulations of the facility are reviewed at least annually and revised 
as necessary by the administrative staff, medical director, and other 
appropriate personnel of the facility, and are adopted when approved by 
the governing body.
    (c) Standard: chief executive officer. The governing body appoints a 
qualified chief executive officer who, as the ESRD facility's 
administrator: Is responsible for the overall management of the 
facility; enforces the rules and regulations relative to the level of 
health care and safety of patients, and to the protection of their 
personal and property rights; and plans, organizes, and directs those 
responsibilities delegated to him by the governing body. Through 
meetings and periodic reports, the chief executive officer maintains on-
going liaison among the governing body, medical and nursing personnel, 
and other professional and supervisory staff of the facility, and acts 
upon recommendations made by the medical staff and the governing body. 
In the absence of the chief executive officer, a qualified person is 
authorized in writing to act on the officer's behalf.
    (1) The governing body delineates in writing the responsibilities of 
the chief executive officer, and ensures that he/she is sufficiently 
free from other duties to provide effective direction and management of 
the operations and fiscal affairs of the facility.
    (2) The chief executive officer serves on a full-time or part-time 
basis, in accordance with the scope of the facility's operations and 
administrative needs, and devotes sufficient time to the conduct of such 
responsibilities.
    (3) The responsibilities of the chief executive officer include but 
are not limited to:
    (i) Implementing the policies of the facility and coordinating the 
provision of services, in accordance with delegations by the governing 
body.
    (ii) Organizing and coordinating the administrative functions of the 
facility, redelegating duties as authorized, and establishing formal 
means of accountability for those involved in patient care.
    (iii) Authorizing expenditures in accordance with established 
policies and procedures.
    (iv) Familiarizing the staff with the facility's policies, rules, 
and regulations, and with applicable Federal, State, and local laws and 
regulations.
    (v) Maintaining and submitting such records and reports, including a 
chronological record of services provided to patients, as may be 
required by the facility's internal committees and governing body, or as 
required by the Secretary.
    (vi) Participating in the development, negotiation, and 
implementation of agreements or contracts into which the facility may 
enter, subject to approval by the governing body of such agreements or 
contracts.
    (vii) Participating in the development of the organizational plan 
and ensuring the development and implementation of an accounting and 
reporting system, including annual development of a detailed budgetary 
program, maintenance of fiscal records, and quarterly submission to the 
governing body of reports of expenses and revenues generated through the 
facility's operation.

[[Page 140]]

    (viii) Ensuring that the facility employs the number of qualified 
personnel needed; that all employees have appropriate orientation to the 
facility and their work responsibilities upon employment; and that they 
have an opportunity for continuing education and related development 
activities.
    (d) Standard: personnel policies and procedures. The governing body, 
through the chief executive officer of the ESRD facility, is responsible 
for maintaining and implementing written personnel policies and 
procedures that support sound patient care and promote good personnel 
practices. These policies and procedures ensure that:
    (1) All members of the facility's staff are qualified to perform the 
duties and responsibilities assigned to them and meet such Federal, 
State, and local professional requirements as may apply.
    (2) A safe and sanitary environment for patients and personnel 
exists, and reports of incidents and accidents to patients and personnel 
are reviewed to identify health and safety hazards. Health supervision 
of personnel is provided, and they are referred for periodic health 
examinations and treatments as necessary or as required by Federal, 
State, and local laws. Procedures are established for routine testing to 
ensure detection of hepatitis and other infectious diseases.
    (3) If the services of trainees are utilized in providing ESRD 
services, such trainees are under the direct supervision of qualified 
professional personnel.
    (4) Complete personnel records are maintained on all personnel. 
These include health status reports, resumes of training and experience, 
and current job descriptions that reflect the employees' 
responsibilities and work assignments.
    (5) Personnel policies are written and made available to all 
personnel in the facility. The policies provide for an effective 
mechanism to handle personnel grievances.
    (6) All personnel of the facility participate in educational 
programs on a regular basis. These programs cover initial orientation, 
and continuing inservice training, including procedures for infection 
control. Records are maintained showing the content of training sessions 
and the attendance at such sessions.
    (7) Personnel manuals are maintained, periodically updated, and made 
available to all personnel involved in patient care.
    (e) Standard: use of outside resources. If the ESRD facility makes 
arrangements for the provision of a specific service as authorized in 
this subpart, the responsibilities, functions, objectives, and the terms 
of each arrangement, including financial provisions and charges, are 
delineated in a document signed by an authorized representative of the 
facility and the person or agency providing the service. The chief 
executive officer when utilizing outside resource, as a consultant, 
assures that he is apprised of recommendations, plans for 
implementation, and continuing assessment through dated, signed reports, 
which are retained by the chief executive officer for follow-up action 
and evaluation of performance.
    (f) Standard: patient care policies. The ESRD facility has written 
policies, approved by the governing body, concerning the provision of 
dialysis and other ESRD services to patients. The governing body reviews 
implementation of policies periodically to ensure that the intent of the 
policies is carried out. These policies are developed by the physician 
responsible for supervising and directing the provision of ESRD 
services, or the facility's organized medical staff (if there is one), 
with the advice of (and with provision for review of such policies from 
time to time, but at least annually, by) a group of professional 
personnel associated with the facility, including, but not limited to, 
one or more physicians and one or more registered nurses experienced in 
rendering ESRD care.
    (1) The patient care policies cover the following:
    (i) Scope of services provided by the facility (either directly or 
under arrangement).
    (ii) Admission and discharge policies (in relation to both in-
facility care and home care).
    (iii) Medical supervision and physician services.

[[Page 141]]

    (iv) Patient long term programs, patient care plans and methods of 
implementation.
    (v) Care of patients in medical and other emergencies.
    (vi) Pharmaceutical services.
    (vii) Medical records (including those maintained in the ESRD 
facility and in the patients' homes, to ensure continuity of care).
    (viii) Administrative records.
    (ix) Use and maintenance of the physical plant and equipment.
    (x) Consultant qualifications, functions, and responsibilities.
    (xi) The provision of home dialysis support services, if offered 
(see Sec. 405.2163(e)).
    (2) The physician-director of the facility is designated in writing 
to be responsible for the execution of patient care policies. If the 
responsibility for day-to-day execution of patient care policies has 
been delegated by a physican director to (or, in the case of a self-
dialysis unit, to another licensed health practitioner) a registered 
nurse, the physican-director provides medical guidance in such matters.
    (3) The facility policy provides that, whenever feasible, hours for 
dialysis are scheduled for patient convenience and that arrangements are 
made to accommodate employed patients who wish to be dialyzed during 
their non-working hours.
    (4) The governing body adopts policies to ensure there is evaluation 
of the progress each patient is making toward the goals stated in the 
patient's long term program and patient's care plan (see 
Sec. 405.2137(a)). Such evaluations are carried out through regularly 
scheduled conferences, with participation by the staff involved in the 
patient's care.
    (g) Standard: medical supervision and emergency coverage. The 
governing body of the ESRD dialysis and/or transplant facility ensures 
that the health care of every patient is under the continuing 
supervision of a physician and that a physician is available in 
emergency situations.
    (1) The physician responsible for the patient's medical supervision 
evaluates the patient's immediate and long-term needs and on this basis 
prescribes a planned regimen of care which covers indicated dialysis and 
other ESRD treatments, services, medications, diet, special procedures 
recommended for the health and safety of the patient, and plans for 
continuing care and discharge. Such plans are made with input from other 
professional personnel involved in the care of the patient.
    (2) The governing body ensures that there is always available 
medical care for emergencies, 24 hours a day, 7 days a week. There is 
posted at the nursing/monitoring station a roster with the names of the 
physicians to be called, when they are available for emergencies, and 
how they can be reached.
    (h) Standard: medical staff. The governing body of the ESRD facility 
designates a qualified physician (see Sec. 405.2102) as director of the 
ESRD services; the appointment is made upon the recommendation of the 
facility's organized medical staff, if there is one. The governing body 
establishes written policies regarding the development, negotiation, 
consummation, evaluation, and termination of appointments to the medical 
staff.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 43 FR 48952, Oct. 19, 1978; 51 FR 30362, Aug. 26, 1986; 
52 FR 36934, Oct. 2, 1987]



Sec. 405.2137  Condition: Patient long-term program and patient care plan.

    Each facility maintains for each patient a written long-term program 
and a written patient care plan to ensure that each patient receives the 
appropriate modality of care and the appropriate care within that 
modality. The patient, or where appropriate, parent or legal guardian is 
involved with the health team in the planning of care. A copy of the 
current program and plan accompany the patient on interfacility 
transfer.
    (a) Standard: patient long-term program. There is a written long-
term program representing the selection of a suitable treatment modality 
(i.e., dialysis or transplantation) and dialysis setting (e.g., home, 
self-care) for each patient.
    (1) The program is developed by a professional team which includes 
but is not limited to the physician director of the dialysis facility or 
center where the patient is currently being treated,

[[Page 142]]

a physician director of a center or facility which offers self-care 
dialysis training (if not available at the location where the patient is 
being treated), a transplant surgeon, a qualified nurse responsible for 
nursing services, a qualified dietitian and a qualified social worker.
    (2) The program is formally reviewed and revised in writing as 
necessary by a team which includes but is not limited to the physician 
director of the dialysis facility or center where the patient is 
presently being treated, in addition to the other personnel listed in 
paragraph (a)(1) of this section at least every 12 months or more often 
as indicated by the patient's response to treatment (see 
Sec. 405.2161(b)(1) and Sec. 405.2170(a)).
    (3) The patient, parent, or legal guardian, as appropriate, is 
involved in the development of the patient's long-term program, and due 
consideration is given to his preferences.
    (4) A copy of the patient's long-term program accompanies the 
patient on interfacility transfer or is sent within 1 working day.
    (b) Standard: patient care plan. There is a written patient care 
plan for each patient of an ESRD facility (including home dialysis 
patients under the supervision of the ESRD facility; see 
Sec. 405.2163(e)), based upon the nature of the patient's illness, the 
treatment prescribed, and an assessment of the patient's needs.
    (1) The patient care plan is personalized for the individual, 
reflects the psychological, social, and functional needs of the patient, 
and indicates the ESRD and other care required as well as the 
individualized modifications in approach necessary to achieve the long-
term and short-term goals.
    (2) The plan is developed by a professional team consisting of at 
least the physician responsible for the patient's ESRD care, a qualified 
nurse responsible for nursing services, a qualified social worker, and a 
qualified dietitian.
    (3) The patient, parent, or legal guardian, as appropriate, is 
involved in the development of the care plan, and due consideration is 
given to his preferences.
    (4) The care plan for patients whose medical condition has not 
become stabilized is reviewed at least monthly by the professional 
patient care team described in paragraph (b)(2) of this section. For 
patients whose condition has become stabilized, the care plan is 
reviewed every 6 months. The care plan is revised as necessary to insure 
that it provides for the patients ongoing needs.
    (5) If the patient is transferred to another facility, the care plan 
is sent with the patient or within 1 working day.
    (6) For a home-dialysis patient whose care is under the supervision 
of the ESRD facility, the care plan provides for periodic monitoring of 
the patient's home adaptation, including provisions for visits to the 
home by qualified facility personnel to the extent appropriate. (See 
Sec. 405.2163(e).)
    (7) Beginning July 1, 1991, for a home dialysis patient, and 
beginning January 1, 1994, for any dialysis patient, who uses EPO in the 
home, the plan must provide for monitoring home use of EPO that includes 
the following:
    (i) Review of diet and fluid intake for indiscretions as indicated 
by hyperkalemia and elevated blood pressure secondary to volume 
overload.
    (ii) Review of medications to ensure adequate provision of 
supplemental iron.
    (iii) Ongoing evaluations of hematocrit and iron stores.
    (iv) A reevaluation of the dialysis prescription taking into account 
the patient's increased appetite and red blood cell volume.
    (v) A method for physician followup on blood tests and a mechanism 
(such as a patient log) for keeping the physician informed of the 
results.
    (vi) Training of the patient to identify the signs and symptoms of 
hypotension and hypertension.
    (vii) The decrease or discontinuance of EPO if hypertension is 
uncontrollable.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48952, Oct. 19, 1978; 59 FR 1284, Jan. 10, 1994; 59 
FR 26958, May 25, 1994]



Sec. 405.2138  Condition: Patients' rights and responsibilities.

    The governing body of the ESRD facility adopts written policies 
regarding

[[Page 143]]

the rights and responsibilities of patients and, through the chief 
executive officer, is responsible for development of, and adherence to, 
procedures implementing such policies. These policies and procedures are 
made available to patients and any guardians, next of kin, sponsoring 
agency(ies), representative payees (selected pursuant to section 205(j) 
of the Social Security Act and subpart Q of 20 CFR part 404), and to the 
public. The staff of the facility is trained and involved in the 
execution of such policies and procedures. The patients' rights policies 
and procedures ensure at least the following:
    (a) Standard: informed patients. All patients in the facility:
    (1) Are fully informed of these rights and responsibilities, and of 
all rules and regulations governing patient conduct and 
responsibilities;
    (2) Are fully informed of services available in the facility and of 
related charges including any charges for services not covered under 
title XVIII of the Social Security Act;
    (3) Are fully informed by a physician of their medical condition 
unless medically contraindicated (as documented in their medical 
records);
    (4) Are fully informed regarding the facility's reuse of dialysis 
supplies, including hemodialyzers. If printed materials such as 
brochures are utilized to describe a facility and its services, they 
must contain a statement with respect to reuse; and
    (5) Are fully informed regarding their suitability for 
transplantation and home dialysis.
    (b) Standard: participation in planning. All patients treated in the 
facility:
    (1) Are afforded the opportunity to participate in the planning of 
their medical treatment and to refuse to participate in experimental 
research;
    (2) Are transferred or discharged only for medical reasons or for 
the patient's welfare or that of other patients, or for nonpayment of 
fees (except as prohibited by title XVIII of the Social Security Act), 
and are given advance notice to ensure orderly transfer or discharge.
    (c) Standard: respect and dignity. All patients are treated with 
consideration, respect, and full recognition of their individuality and 
personal needs, including the need for privacy in treatment. Provision 
is made for translators where a significant number of patients exhibit 
language barriers.
    (d) Standard: confidentiality. All patients are ensured confidential 
treatment of their personal and medical records, and may approve or 
refuse release of such records to any individual outside the facility, 
except in case of their transfer to another health care institution or 
as required by Federal, State, or local law and the Secretary for proper 
administration of the program.
    (e) Standard: grievance mechanism. All patients are encouraged and 
assisted to understand and exercise their rights. Grievances and 
recommended changes in policies and services may be addressed to 
facility staff, administration, the network organization, and agencies 
or regulatory bodies with jurisdiction over the facility, through any 
representative of the patient's choice, without restraint or 
interference, and without fear of discrimination or reprisal.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 51 FR 30362, Aug. 26, 1986; 52 FR 36934, Oct. 2, 1987]



Sec. 405.2139  Condition: Medical records.

    The ESRD facility maintains complete medical records on all patients 
(including self-dialysis patients within the self-dialysis unit and home 
dialysis patients whose care is under the supervision of the facility) 
in accordance with accepted professional standards and practices. A 
member of the facility's staff is designated to serve as supervisor of 
medical records services, and ensures that all records are properly 
documented, completed, and preserved. The medical records are completely 
and accurately documented, readily available, and systematically 
organized to facilitate the compilation and retrieval of information.
    (a) Standard: medical record. Each patient's medical record contains 
sufficient information to identify the patient clearly, to justify the 
diagnosis and treatment, and to document the results accurately. All 
medical records contain the following general categories of information: 
Documented evidence of assessment of the needs of the patient, whether 
the patient is

[[Page 144]]

treated with a reprocessed hemodialyzer, of establishment of an 
appropriate plan of treatment, and of the care and services provided 
(see Sec. 405.2137(a) and (b)); evidence that the patient was informed 
of the results of the assessment described in Sec. 405.2138(a)(5); 
identification and social data; signed consent forms referral 
information with authentication of diagnosis; medical and nursing 
history of patient; report(s) of physician examination(s); diagnostic 
and therapeutic orders; observations, and progress notes; reports of 
treatments and clinical findings; reports of laboratory and other 
diagnostic tests and procedures; and discharge summary including final 
diagnosis and prognosis.
    (b) Standard: protection of medical record information. The ESRD 
facility safeguards medical record information against loss, 
destruction, or unauthorized use. The ESRD facility has written policies 
and procedures which govern the use and release of information contained 
in medical records. Written consent of the patient, or of an authorized 
person acting in behalf of the patient, is required for release of 
information not provided by law. Medical records are made available 
under stipulation of confidentiality for inspection by authorized agents 
of the Secretary, as required for administration of the ESRD program 
under Medicare.
    (c) Standard: medical records supervisor. A member of the ESRD 
facility's staff is designated to serve as supervisor of the facility's 
medical records service. The functions of the medical records supervisor 
include, but are not limited to, the following: Ensuring that the 
records are documented, completed, and maintained in accordance with 
accepted professional standards and practices; safeguarding the 
confidentiality of the records in accordance with established policy and 
legal requirements; ensuring that the records contain pertinent medical 
information and are filed for easy retrieval. When necessary, 
consultation is secured from a qualified medical record practitioner.
    (d) Standard: Completion of medical records and centralization of 
clinical information. Current medical records and those of discharged 
patients are completed promptly. All clinical information pertaining to 
a patient is centralized in the patient's medical record. Provision is 
made for collecting and including in the medical record medical 
information generated by self-dialysis patients. Entries concerning the 
daily dialysis process may either be completed by staff, or be completed 
by trained self-dialysis patients, trained home dialysis patients or 
trained assistants and countersigned by staff.
    (e) Standard: retention and preservation of records. Medical records 
are retained for a period of time not less than that determined by the 
State statute governing records retention or statute of limitations; or 
in the absence of a State statute, 5 years from the date of discharge; 
or, in the case of a minor, 3 years after the patient becomes of age 
under State law, whichever is longest.
    (f) Standard: location and facilities. The facility maintains 
adequate facilities, equipment, and space conveniently located, to 
provide efficient processing of medical records (e.g., reviewing, 
filing, and prompt retrieval) and statistical medical information (e.g., 
required abstracts, reports, etc.).
    (g) Standard: transfer of medical information. The facility provides 
for the interchange of medical and other information necessary or useful 
in the care and treatment of patients transferred between treating 
facilities, or in determining whether such patients can be adequately 
cared for otherwise than in either of such facilities.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48952, Oct. 19, 1978; 52 FR 36934, Oct. 2, 1987]



Sec. 405.2140  Condition: Physical environment.

    The physical environment in which ESRD services are furnished 
affords a functional, sanitary, safe, and comfortable setting for 
patients, staff, and the public.
    (a) Standard: building and equipment. The physical structure in 
which ESRD services are furnished is constructed, equipped, and 
maintained to insure the safety of patients, staff, and the public.
    (1) Fire extinguishers are conveniently located on each floor of the 
facility and in areas of special hazard.

[[Page 145]]

Fire regulations and fire management procedures are prominently posted 
and properly followed.
    (2) All electrical and other equipment used in the facility is 
maintained free of defects which could be a potential hazard to patients 
or personnel. There is established a planned program of preventive 
maintenance of equipment used in dialysis and related procedures in the 
facility.
    (3) The areas used by patients are maintained in good repair and 
kept free of hazards such as those created by damaged or defective parts 
of the building.
    (4)  [Reserved]
    (5)(i) The ESRD facility must employ the water quality requirements 
listed in paragraph (a)(5)(ii) of this section developed by the 
Association for the Advancement of Medical Instrumentation (AAMI) and 
published in ``Hemodialysis Systems,'' second edition, which is 
incorporated by reference.
    (ii) Required water quality requirements are those listed in 
sections 3.2.1, Water Bacteriology; 3.2.2, Maximum Level of Chemical 
Contaminants; and in Appendix B: Guideline for Monitoring Purity of 
Water Used for Hemodialysis as B1 through B5.
    (iii) Incorporation by reference of the AAMI's ``Hemodialysis 
Systems,'' second edition, 1992, was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51.1 If any changes in ``Hemodialysis Systems,'' second 
edition, are also to be incorporated by reference, a notice to that 
effect will be published in the Federal Register.
---------------------------------------------------------------------------

    \1\ The publication entitled ``Hemodialysis Systems,'' second 
edition, 1992, is available for inspection at the HCFA Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD 21244-1850 and 
the Office of the Federal Register, 800 North Capitol Street, NW., Suite 
700, Washington, DC. Copies may be purchased from the Association for 
the Advancement of Medical Instrumentation, 3300 Washington Boulevard, 
Suite 400, Arlington, VA 22201-4598.
---------------------------------------------------------------------------

    (b) Standard: favorable environment for patients. The facility is 
maintained and equipped to provide a functional sanitary, and 
comfortable environment with an adequate amount of well-lighted space 
for the service provided.
    (1) There are written policies and procedures in effect for 
preventing and controlling hepatitis and other infections. These 
policies include, but are not limited to, appropriate procedures for 
surveillance and reporting of infections, housekeeping, handling and 
disposal of waste and contaminants, and sterilization and disinfection, 
including the sterilization and maintenance of equipment where dialysis 
supplies are reused, there are written policies and procedures covering 
the rinsing, cleaning, disinfection, preparation and storage of reused 
items which conform to requirements for reuse in Sec. 405.2150.
    (2) Treatment areas are designed and equipped to provide adequate 
and safe dialysis therapy, as well as privacy and comfort for patients. 
The space for treating each patient is sufficient to accomodate 
medically needed emergency equipment and staff and to ensure that such 
equipment and staff can reach the patient in an emergency. There is 
sufficient space in units for safe storage of self-dialysis supplies.
    (3) There is a nursing/monitoring station from which adequate 
surveillance of patients receiving dialysis services can be made.
    (4) Heating and ventilation systems are capable of maintaining 
adequate and comfortable temperatures.
    (5) Each ESRD facility utilizing a central-batch delivery system 
provides, either on the premises or through affiliation agreement or 
arrangement (see Sec. 405.2160) sufficient individual delivery systems 
for the treatment of any patient requiring special dialysis solutions.
    (c) Standard contamination prevention. The facility employs 
appropriate techniques to prevent cross-contamination between the unit 
and adjacent hospital or public areas including, but not limited to, 
food service areas, laundry, disposal of solid waste and blood-
contaminated equipment, and disposal of contaminants into sewage 
systems. Waste storage and disposal are carried out in accordance with 
applicable local laws and accepted public health procedures. The written 
patient care policies (see Sec. 405.2136(f)(1)) specify the functions 
that are carried out by facility personnel and by the self-dialysis 
patients

[[Page 146]]

with respect to contamination prevention. Where dialysis supplies are 
reused, records are maintained that can be used to determine whether 
established procedures covering the rinsing, cleaning, disinfection, 
preparation and storage of reused items, conform to requirements for 
reuse in Sec. 405.2150.
    (d) Standard: emergency preparedness. Written policies and 
procedures specifically define the handling of emergencies which may 
threaten the health or safety of patients. Such emergencies would exist 
during a fire or natural disaster or during functional failures in 
equipment. Specific emergency preparedness procedures exist for 
different kinds of emergencies. These are reviewed and tested at least 
annually and revised as necessary by, or under the direction of, the 
chief executive officer. All personnel are knowledgeable and trained in 
their respective roles in emergency situations.
    (1) There is an established written plan for dealing with fire and 
other emergencies which, when necessary, is developed in cooperation 
with fire and other expert personnel.
    (2) All personnel are trained, as part of their employment 
orientation, in all aspects of preparedness for any emergency or 
disaster. The emergency preparedness plan provides for orientation and 
regular training and periodic drills for all personnel in all procedures 
so that each person promptly and correctly carries out a specified role 
in case of an emergency.
    (3) There is available at all times on the premises a fully equipped 
emergency tray, including emergency drugs, medical supplies, and 
equipment, and staff are trained in its use.
    (4) The staff is familiar with the use of all dialysis equipment and 
procedures to handle medical emergencies.
    (5) Patients are trained to handle medical and nonmedical 
emergencies. Patients must be fully informed regarding what to do, where 
to go, and whom to contact if a medical or nonmedical emergency occurs.

(Secs. 1102, 1871, 1881(b), Social Security Act; 42 U.S.C. 1302, 1395hh, 
1395rr(b))

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48952, Oct. 19, 1978; 45 FR 24839, Apr. 10, 1980; 52 
FR 36934, Oct. 2, 1987; 60 FR 48043, Sept. 18, 1995]



Sec. 405.2150  Condition: Reuse of hemodialyzers and other dialysis supplies.

    An ESRD facility that reuses hemodialyzers and other dialysis 
supplies meets the requirements of this section. Failure to meet any of 
paragraphs (a) through (c) of this section constitutes grounds for 
denial of payment for the dialysis treatment affected and termination 
from participation in the Medicare program.
    (a) Standard: Hemodialyzers. If the ESRD facility reuses 
hemodialyzers, it conforms to the following:
    (1) Reuse guidelines. Voluntary guidelines adopted by the AAMI 
(``Reuse of Hemodialyzers,'' second edition). Incorporation by reference 
of the AAMI's ``Reuse of Hemodialyzers,'' second edition, 1993, was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51.1 If any changes in ``Reuse 
of Hemodialyzers,'' second edition, are also to be incorporated by 
reference, a notice to that effect will be published in the Federal 
Register.
---------------------------------------------------------------------------

    \1\ The publication entitled ``Reuse of Hemodialyzers,'' second 
edition, 1993, is available for inspection at the HCFA Information 
Resources Center, 7500 Security Boulevard, Baltimore, MD 21244-1850 and 
the Office of the Federal Register, 800 North Capitol Street, NW., Suite 
700, Washington, DC. Copies may be purchased from the Association for 
the Advancement of Medical Instrumentation, 3300 Washington Boulevard, 
Suite 400, Arlington, VA 22201-4598.
---------------------------------------------------------------------------

    (2) Procedure for chemical germicides. To prevent any risk of 
dialyzer membrane leaks due to the combined action of different chemical 
germicides,

[[Page 147]]

dialyzers are exposed to only one chemical germicide during the 
reprocessing procedure. If a dialyzer is exposed to a second germicide, 
the dialyzer must be discarded.
    (3) Surveillance of patient reactions. In order to detect bacteremia 
and to maintain patient safety when unexplained events occur, the 
facility--
    (i) Takes appropriate blood cultures at the time of a febrile 
response in a patient; and
    (ii) If pyrogenic reactions, bacteremia, or unexplained reactions 
associated with ineffective reprocessing are identified, terminates 
reuse of hemodialyzers in that setting and does not continue reuse until 
the entire reprocessing system has been evaluated.
    (b) Standard: Transducer filters. To control the spread of 
hepatitis, transducer filters are changed after each dialysis treatment 
and are not reused.
    (c) Standard: Bloodlines. If the ESRD facility reuses bloodlines, it 
must--
    (1) Limit the reuse of bloodlines to the same patient;
    (2) Not reuse bloodlines labeled for ``single use only'';
    (3) Reuse only bloodlines for which the manufacturer's protocol for 
reuse has been accepted by the Food and Drug Administration (FDA) 
pursuant to the premarket notification (section 510(k)) provision of the 
Food, Drug, and Cosmetic Act; and
    (4) Follow the FDA-accepted manufacturer's protocol for reuse of 
that bloodline.

[52 FR 36935, Oct. 2, 1987, as amended at 55 FR 18335, May 2, 1990; 60 
FR 48044, Sept. 18, 1995]



Sec. 405.2160  Condition: Affiliation agreement or arrangement.

    (a) A renal dialysis facility and a renal dialysis center (see 
Sec. 405.2102(e)(2)) have in effect an affiliation agreement or 
arrangement with each other, in writing, for the provision of inpatient 
care and other hospital services.
    (b) The affiliation agreement or arrangement provides the basis for 
effective working relationships under which inpatient hospital care or 
other hospital services are available promptly to the dialysis 
facility's patients when needed. The dialysis facility has in its files 
documentation from the renal dialysis center to the effect that patients 
from the dialysis facility will be accepted and treated in emergencies. 
There are reasonable assurances that:
    (1) Transfer or referral of patients will be effected between the 
renal dialysis center and the dialysis facility whenever such transfer 
or referral is determined as medically appropriate by the attending 
physician, with timely acceptance and admission;
    (2) There will be interchange, within 1 working day, of the patient 
long-term program and patient care plan, and of medical and other 
information necessary or useful in the care and treatment of patients 
transferred or referred between the facilities, or in determining 
whether such patients can be adequately cared for otherwise than in 
either of such facilities; and
    (3) Security and accountability for patients' personal effects are 
assured.



Sec. 405.2161  Condition: Director of a renal dialysis facility or renal dialysis center.

    Treatment is under the general supervision of a Director who is a 
physician. The physician-director need not devote full time as Director 
but is responsible for planning, organizing, conducting, and directing 
the professional ESRD services and must devote sufficient time to 
carrying out these responsibilities. The director may also serve as the 
Chief Executive Officer of the facility.
    (a) Standard: qualifications. The director of a dialysis facility is 
a qualified physician-director. (See Sec. 405.2102.)
    (b) Standard: responsibilities. The responsibilities of the 
physician-director include but are not limited to the following:
    (1) Participating in the selection of a suitable treatment modality, 
i.e., transplantation or dialysis, and dialysis setting, for all 
patients;
    (2) Assuring adequate training of nurses and technicians in dialysis 
techniques;
    (3) Assuring adequate monitoring of the patient and the dialysis 
process, including, for self-dialysis patients, assuring periodic 
assessment of patient performance of dialysis tasks;
    (4) Assuring the development and availability of a patient care 
policy

[[Page 148]]

and procedures manual and its implementation. As a minimum, the manual 
describes the types of dialysis used in the facility and the procedures 
followed in performance of such dialysis; hepatitis prevention and 
procedures for handling an individual with hepatitis; and a disaster 
preparedness plan (e.g., patient emergency, fire, flood); and
    (5) When self-dialysis training or home dialysis training is 
offered, assuring that patient teaching materials are available for the 
use of all trainees during training and at times other than during the 
dialysis procedure.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48952, Oct. 19, 1978; 51 FR 30362, Aug. 26, 1986]



Sec. 405.2162  Condition: Staff of a renal dialysis facility or renal dialysis center.

    Properly trained personnel are present in adequate numbers to meet 
the needs of the patients, including those arising from medical and 
nonmedical emergencies.
    (a) Standard: Registered nurse. The dialysis facility employs at 
least one full time qualified nurse responsible for nursing service. 
(See Sec. 405.2102.)
    (b) Standard: On-duty personnel. Whenever patients are undergoing 
dialysis:
    (1) One currently licensed health professional (e.g., physician, 
registered nurse, or licensed practical nurse) experienced in rendering 
ESRD care is on duty to oversee ESRD patient care;
    (2) An adequate number of personnel are present so that the patient/
staff ratio is appropriate to the level of dialysis care being given and 
meets the needs of patients; and
    (3) An adequate number of personnel are readily available to meet 
medical and nonmedical needs.
    (c) Standard: Self-care dialysis training personnel. If the facility 
offers self-care dialysis training, a qualified nurse is in charge of 
such training (see Sec. 405.2102.)

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 43 FR 48953, Oct. 19, 1978; 51 FR 30362, Aug. 26, 1986]



Sec. 405.2163  Condition: Minimal service requirements for a renal dialysis facility or renal dialysis center.

    The facility must provide dialysis services, as well as adequate 
laboratory, social, and dietetic services to meet the needs of the ESRD 
patient.
    (a) Standard: Outpatient dialysis services--(1) Staff-assisted 
dialysis services. The facility must provide all necessary institutional 
dialysis services and staff required in performing the dialysis.
    (2) Self-dialysis services. If the facility offers self-dialysis 
services, it must provide all medically necessary supplies and equipment 
and any other service specified in the facility's patient care policies.
    (b) Standard: Laboratory services. The dialysis facility makes 
available laboratory services (other than the specialty of tissue 
pathology and histocompatibility testing), to meet the needs of the ESRD 
patient. All laboratory services must be performed by an appropriately 
certified laboratory in accordance with part 493 of this chapter. If the 
renal dialysis facility furnishes its own laboratory services, it must 
meet the applicable requirements established for certification of 
laboratories found in part 493 of this chapter. If the facility does not 
provide laboratory services, it must make arrangements to obtain these 
services from a laboratory certified in the appropriate specialties and 
subspecialties of service in accordance with the requirements of part 
493 of this chapter.
    (c) Standard: Social services. Social services are provided to 
patients and their families and are directed at supporting and 
maximizing the social functioning and adjustment of the patient. Social 
services are furnished by a qualified social worker (Sec. 405.2102) who 
has an employment or contractual relationship with the facility. The 
qualified social worker is responsible for conducting psychosocial 
evaluations, participating in team review of patient progress and 
recommending changes in treatment based on the patient's current 
psychosocial needs, providing casework and groupwork services to 
patients and their families in dealing with the special problems 
associated

[[Page 149]]

with ESRD, and identifying community social agencies and other resources 
and assisting patients and families to utilize them.
    (d) Standard: Dietetic services. Each patient is evaluated as to his 
nutritional needs by the attending physician and by a qualified 
dietician (Sec. 405.2102) who has an employment or contractual 
relationship with the facility. The dietician, in consultation with the 
attending physician, is responsible for assessing the nutritional and 
dietetic needs of each patient, recommending therapeutic diets, 
counseling patients and their families on prescribed diets, and 
monitoring adherence and response to diets.
    (e) Standard: Self-dialysis support services. The renal dialysis 
facility or center furnishing self-dialysis training upon completion of 
the patient's training, furnishes (either directly, under agreement or 
by arrangement with another ESRD facility) the following services:
    (1) Surveillance of the patient's home adaptation, including 
provisions for visits to the home or the facility;
    (2) Consultation for the patient with a qualified social worker and 
a qualified dietitian;
    (3) A recordkeeping system which assures continuity of care;
    (4) Installation and maintenance of equipment;
    (5) Testing and appropriate treatment of the water; and
    (6) Ordering of supplies on an ongoing basis.
    (f) Standard: Participation in recipient registry. The dialysis 
facility or center participates in a patient registry program with an 
OPO designated or redesignated under part 486, subpart G of this 
chapter, for patients who are awaiting cadaveric donor transplantation.
    (g) Use of EPO at home: Patient selection. The dialysis facility, or 
the physician responsible for all dialysis-related services furnished to 
the patient, must make a comprehensive assessment that includes the 
following:
    (1) Pre-selection monitoring. The patient's hematocrit (or 
hemoglobin), serum iron, transferrin saturation, serum ferritin, and 
blood pressure must be measured.
    (2) Conditions the patient must meet. The assessment must find that 
the patient meets the following conditions:
    (i) On or after July 1, 1991, is a home dialysis patient or, on or 
after January 1, 1994, is a dialysis patient;
    (ii) Has a hematocrit (or comparable hemoglobin level) that is as 
follows:
    (A) For a patient who is initiating EPO treatment, no higher than 30 
percent unless there is medical documentation showing the need for EPO 
despite a hematocrit (or comparable hemoglobin level) higher than 30 
percent. (Patients with severe angina, severe pulmonary distress, or 
severe hypertension may require EPO to prevent adverse symptoms even if 
they have higher hematocrit or hemoglobin levels.)
    (B) For a patient who has been receiving EPO from the facility or 
the physician, between 30 and 33 percent.
    (iii) Is under the care of--
    (A) A physician who is responsible for all dialysis-related services 
and who prescribes the EPO and follows the drug labeling instructions 
when monitoring the EPO home therapy; and
    (B) A renal dialysis facility that establishes the plan of care and 
monitors the progress of the home EPO therapy.
    (3) Conditions the patient or the patient's caregiver must meet. The 
assessment must find that the patient or a caregiver who assists the 
patient in performing self-dialysis meets the following conditions:
    (i) Is trained by the facility to inject EPO and is capable of 
carrying out the procedure.
    (ii) Is capable of reading and understanding the drug labeling.
    (iii) Is trained in, and capable of observing, aseptic techniques.
    (4) Care and storage of drug. The assessment must find that EPO can 
be stored in the patient's residence under refrigeration and that the 
patient is aware of the potential hazard of a child's having access to 
the drug and syringes.
    (h) Use of EPO at home: Responsibilities of the physician or the 
dialysis facility. The patient's physician or dialysis facility must--
    (1) Develop a protocol that follows the drug label instructions;

[[Page 150]]

    (2) Make the protocol available to the patient to ensure safe and 
effective home use of EPO; and
    (3) Through the amounts prescribed, ensure that the drug ``on hand'' 
at any time does not exceed a 2-month supply.

[43 FR 48953, Oct. 19, 1978, as amended at 51 FR 30362, Aug. 26, 1986; 
57 FR 7134, Feb. 28, 1992; 59 FR 1284, Jan. 10, 1994; 59 FR 26958, May 
25, 1994; 59 FR 46513, Sept. 8, 1994; 61 FR 19743, May 2, 1996]



Sec. 405.2164  Conditions for coverage of special purpose renal dialysis facilities.

    (a) A special purpose renal dialysis facility must comply with all 
conditions for coverage for renal dialysis facilities specified in 
Secs. 405.2130 through 405.2164, with the exception of Secs. 405.2134, 
and 405.2137 that relate to participation in the network activities and 
patient long-term programs.
    (b) A special purpose renal dialysis facility must consult with a 
patient's physician to assure that care provided in the special purpose 
dialysis facility is consistent with the patient's long-term program and 
patient care plan required under Sec. 405.2137.
    (c) The period of approval for a special purpose renal dialysis 
facility may not exceed 8 calendar months in any calendar year.
    (d) A special purpose renal dialysis facility may provide services 
only to those patients who would otherwise be unable to obtain 
treatments in the geographical areas served by the facility.

[48 FR 21283, May 11, 1983, as amended at 51 FR 30362, Aug. 26, 1986]



Sec. 405.2170  Condition: Director of a renal transplantation center.

    The renal transplantation center is under the general supervision of 
a qualified transplantation surgeon (Sec. 405.2102) or a qualified 
physician-director (Sec. 405.2102), who need not serve full time. This 
physician is responsible for planning, organizing, conducting, and 
directing the renal transplantation center and devotes sufficient time 
to carry out these responsibilities, which include but are not limited 
to the following:
    (a) Participating in the selection of a suitable treatment modality 
for each patient.
    (b) Assuring adequate training, of nurses in the care of transplant 
patients.
    (c) Assuring that tissue typing and organ procurement services are 
available either directly or under arrangement.
    (d) Assuring that transplantation surgery is performed under the 
direct supervision of a qualified transplantation surgeon.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 51 FR 30362, Aug. 26, 1986; 59 FR 46514, Sept. 8, 1994]



Sec. 405.2171  Condition: Minimal service requirements for a renal transplantation center.

    Kidney transplantation is furnished directly by a hospital that is 
participating as a provider of services in the Medicare program and is 
approved by HCFA as a renal transplantation center. The renal 
transplantation center is under the overall direction of a hospital 
administrator and medical staff; if operated by an organizational 
subsidiary, it is under the direction of an administrator and medical 
staff member (or committee) who are directly responsible to the hospital 
administrator and medical staff, respectively. Patients are accepted for 
transplantation only on the order of a physician and their care 
continues under the supervision of a physician.
    (a) Standard: participation in recipient registry. The renal 
transplantation center participates in a patient registry program with 
an OPO certified or recertified under part 485, subpart D of this 
chapter for patients who are awaiting cadaveric donor transplantation.
    (b) Standard: social services. Social services are provided to 
patients and their families and are directed at supporting and 
maximizing the social functioning and adjustment of the patient. Social 
services are furnished by a qualified social worker (Sec. 405.2102) who 
has an employment or contractual relationship with the facility. The 
qualified social worker is responsible for conducting psychosocial 
evaluations, participating in team review of patient progress and 
recommending changes in treatment based on the patient's current 
psychosocial needs, providing

[[Page 151]]

casework and groupwork services to patients and their families in 
dealing with the special problems associated with ESRD, and identifying 
community social agencies and other resources and assisting patients and 
families to utilize them.
    (c) Standard: dietetic services. Each patient is evaluated as to his 
nutritional needs by the attending physician and a qualified dietician 
(Sec. 405.2102) who has an employment or contractual relationship with 
the facility. The dietician, in consultation with the attending 
physician, is responsible for assessing the nutritional and dietetic 
needs of each patient, recommending therapeutic diets, counseling 
patients and their families on prescribed diets, and monitoring 
adherence and response to diets.
    (d) Standard: Laboratory services: (1) The renal transplantation 
center makes available, directly or under arrangements, laboratory 
services to meet the needs of ESRD patients. Laboratory services are 
performed in a laboratory facility certified in accordance with part 493 
of this chapter.
    (2) Laboratory services for crossmatching of recipient serum and 
donor lymphocytes for pre-formed antibodies by an acceptable technique 
are available on a 24-hour emergency basis.
    (e) Standard: Organ procurement. A renal transplantation center 
using the services of an organ procurement organization designated or 
redesignated under part 485, subpart D of this chapter to obtain donor 
organs has a written agreement covering these services. The renal 
transplantation center agrees to notify HCFA in writing within 30 days 
of the termination of the agreement.

[41 FR 22511, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
as amended at 51 FR 30362, Aug. 26, 1986; 53 FR 6548, Mar. 1, 1988; 57 
FR 7134, Feb. 28, 1992; 59 FR 46514, Sept. 8, 1994]



Sec. 405.2180  Termination of Medicare coverage.

    (a) Except as provided in Sec. 405.2181, failure of a supplier of 
ESRD services to meet one or more of the conditions for coverage set 
forth in this subpart U will result in termination of Medicare coverage 
of the services furnished by that 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 by Sec. 405.2134, coverage may be reinstated when HCFA 
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 this subpart, coverage will not be 
reinstated until HCFA finds that the reason for termination has been 
removed and there is reasonable assurance that it will not recur.

[53 FR 36277, Sept. 19, 1988]



Sec. 405.2181  Alternative sanctions.

    (a) Basis for application of alternative sanctions. HCFA may, as an 
alternative to termination of Medicare coverage, impose one of the 
sanctions specified in paragraph (b) of this section if HCFA finds 
that--
    (1) The supplier fails to participate in the activities and pursue 
the goals of the ESRD network that is designated to encompass its 
geographic area; and
    (2) This failure does not jeopardize patient health and safety.
    (b) Alternative sanctions. The alternative sanctions that HCFA 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 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 sanction.
    (3) Withholding of all payments, without interest, for all ESRD 
services furnished by the supplier to Medicare beneficiaries.
    (c) Duration of sanction. An alternative sanction remains in effect 
until HCFA finds that the supplier is in substantial compliance with the 
requirement to cooperate in the network plans and goals, or terminates 
coverage of

[[Page 152]]

the supplier's services for lack of compliance.

[53 FR 36277, Sept. 19, 1988]



Sec. 405.2182  Notice of sanction and appeal rights: Termination of coverage.

    (a) Notice of sanction. HCFA gives the supplier and the general 
public notice of sanction and of the effective date of the sanction. The 
effective date of the 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.

[53 FR 36277, Sept. 19, 1988]



Sec. 405.2184  Notice of appeal rights: Alternative sanctions.

    If HCFA proposes to apply a sanction specified in Sec. 405.2181(b), 
the following rules apply:
    (a) HCFA gives the facility notice of the proposed sanction and 15 
days in which to request a hearing.
    (b) If the facility requests a hearing, HCFA provides an informal 
hearing by a HCFA 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, HCFA provides the facility and 
the public, at least 30 days before the effective date of the sanction, 
with a written notice that specifies the effective date and the reasons 
for the sanction.

[53 FR 36277, Sept. 19, 1988]

Subparts V-W--[Reserved]



  Subpart X--Rural Health Clinic and Federally Qualified Health Center 
                                Services

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

    Source: 43 FR 8261, Mar. 1, 1978, unless otherwise noted.



Sec. 405.2400  Basis.

    Subpart X is based on the provisions of the following sections of 
the Act: Section 1833 sets forth the amounts of payment for 
supplementary medical insurance services. Section 1861(aa) sets forth 
the rural health clinic services and Federally qualified health center 
services covered by the Medicare program.

[60 FR 63176, Dec. 8, 1995]



Sec. 405.2401  Scope and definitions.

    (a) Scope. This subpart establishes the requirements for coverage 
and reimbursement of rural health clinic and Federally qualified health 
center services under Medicare.
    (b) Definitions. As used in this subpart, unless the context 
indicates otherwise:
    Act means the Social Security Act.
    Allowable costs means costs that are incurred by a clinic or center 
and are reasonable in amount and proper and necessary for the efficient 
delivery of rural health clinic and Federally qualified health center 
services.
    Beneficiary means an individual enrolled in the Supplementary 
Medical Insurance program for the Aged and Disabled (part of title XVIII 
of the Act).
    Coinsurance means that portion of the clinic's charge for covered 
services for which the beneficiary is liable in addition to the 
deductible.
    Carrier means an organization that has a contract with the Secretary 
to administer the benefits covered by this subpart.
    Covered services means items or services for which the beneficiary 
is entitled to have payment made on his or her behalf under this 
subpart.
    Deductible means:
    (1) The first $100 of expenses incurred by the beneficiary during 
any calendar

[[Page 153]]

year for items and services covered under Part B of title XVIII; and
    (2) The expenses incurred for the first 3 pints of blood or 3 units 
of packed red blood cells furnished to a beneficiary during any calendar 
year. (See Secs. 410.160 and 410.161 of this chapter for greater 
detail.)
    Federally qualified health center (FQHC) means an entity that has 
entered into an agreement with HCFA to meet Medicare program 
requirements under Secs. 405.2434 and--
    (1) Is receiving a grant under section 329, 330, or 340 of the 
Public Health Service Act, or is receiving funding from such a grant 
under a contract with the recipient of such a grant and meets the 
requirements to receive a grant under section 329, 330 or 340 of the 
Public Health Service Act;
    (2) Based on the recommendation of the PHS, is determined by HCFA to 
meet the requirements for receiving such a grant;
    (3) Was treated by HCFA, for purposes of part B, as a comprehensive 
federally funded health center (FFHC) as of January 1, 1990; or
    (4) Is an outpatient health program or facility operated by a tribe 
or tribal organizations under the Indian Self-Determination Act or by an 
Urban Indian organization receiving funds under title V of the Indian 
Health Care Improvement Act.
    HCFA stands for Health Care Financing Administration.
    Intermittent nursing care means a medically predictable need for 
nursing care from time to time, but usually not less frequently than 
once every 60 days.
    Nurse-midwife means a registered professional nurse who meets the 
following requirements:
    (1) Is currently licensed to practice in the State as a registered 
professional nurse.
    (2) Is legally authorized under State law or regulations to practice 
as a nurse-midwife.
    (3) Except as provided in paragraph (b)(10)(iv) of this section, has 
completed a program of study and clinical experience for nurse-midwives, 
as specified by the State.
    (4) If the State does not specify a program of study and clinical 
experience that nurse-midwives must complete to practice in that State, 
meets one of the following conditions:
    (i) Is currently certified as a nurse-midwife by the American 
College of Nurse-Midwives.
    (ii) Has satisfactorily completed a formal education program (of at 
least one academic year) that, upon completion, qualifies the nurse to 
take the certification examination offered by the American College of 
Nurse-Midwives.
    (iii) Has successfully completed a formal educational program for 
preparing registered nurses to furnish gynecological and obstetrical 
care to women during pregnancy, delivery, and the postpartum period, and 
care to normal newborns, and was practicing as a nurse-midwife for a 
total of 12 months during any 18-month period from August 8, 1976 to 
July 16, 1982.
    Nurse practitioner and physician assistant means individuals who 
meet the applicable education, training experience and other 
requirements of Sec. 491.2 of this chapter.
    Part-time nursing care means nursing care that is required on less 
than a full-time basis, that is, less than 8 hours a day or 40 hours a 
week.
    Physician means the following:
    (1) A doctor of medicine or osteopathy legally authorized to 
practice medicine and surgery by the State in which the function is 
performed.
    (2) Within limitations as to the specific services furnished, a 
doctor of dentistry or dental or oral surgery, a doctor of optometry, a 
doctor of podiatry or surgical chiropody or a chiropractor. (See section 
1861(r) of the Act for specific limitations.)
    (3) A resident (including residents as defined in Sec. 415.152 of 
this chapter who meet the requirements in Sec. 415.206(b) of this 
chapter for payment under the physician fee schedule).
    Reporting period means a period of 12 consecutive months specified 
by the intermediary as the period for which a clinic or center must 
report its costs and utilization. The first and last reporting periods 
may be less than 12 months.
    Rural health clinic means a facility that:

[[Page 154]]

    (1) Has been determined by the Secretary to meet the requirements of 
section 1861(aa)(2) of the Act and part 491 of this chapter; and
    (2) Has filed an agreement with the Secretary in order to provide 
rural health clinic services under Medicare. (See Sec. 405.2402.)
    Secretary means the Secretary of Health and Human Services or his 
delegate.
    Visiting nurse services means part-time or intermittent nursing care 
and related medical supplies (other than drugs or biologicals) furnished 
by a registered nurse or licensed practical nurse to a homebound 
patient.

(Secs. 1102, 1833, 1861(aa), 1871, 1902(a)(13), Social Security Act; 49 
Stat. 647, 79 Stat. 302, 322, and 331, 91 Stat. 1485 (42 U.S.C. 1302, 
1395l, 1395hh, 1395x(aa), and 1396(a)(13))

[43 FR 8261, Mar. 1, 1978, as amended at 43 FR 30526, July 14, 1978; 47 
FR 21049, May 17, 1982; 47 FR 23448, May 28, 1982; 51 FR 41351, Nov. 14, 
1986; 57 FR 24975, June 12, 1992; 59 FR 26958, May 25, 1994; 60 FR 
63176, Dec. 8, 1995; 61 FR 14657, Apr. 3, 1996]



Sec. 405.2402  Basic requirements.

    (a) Certification by the State survey agency. The rural health 
clinic must be certified in accordance with part 491 of this chapter.
    (b) Acceptance of the clinic as qualified to furnish rural health 
clinic services. If the Secretary, after reviewing the survey agency 
recommendation and other evidence relating to the qualifications of the 
rural health clinic, determines that it meets the requirements of this 
subpart and of part 491 of this chapter, he will send the clinic:
    (1) Written notice of the determination; and
    (2) Two copies of the agreement to be filed as required by section 
1861(aa)(1) of the Act.
    (c) Filing of agreement by the rural health clinic. If the rural 
health clinic wishes to participate in the program, it must:
    (1) Have both copies of the agreement signed by an authorized 
representative; and
    (2) File them with the Secretary.
    (d) Acceptance by the Secretary. If the Secretary accepts the 
agreement filed by the rural health clinic, he will return to the clinic 
one copy of the agreement, with a notice of acceptance specifying the 
effective date.
    (e) Duration of agreement. The agreement shall be for a term of one 
year and may be renewed annually by mutual consent of the Secretary and 
the rural health clinic.
    (f) Appeal rights. If the Secretary does not certify a rural health 
clinic, or refuses to enter into or renew an agreement, the facility is 
entitled to a hearing in accordance with part 498 of this chapter.

[43 FR 8261, Mar. 1, 1978, as amended at 52 FR 22454, June 12, 1987]



Sec. 405.2403  Content and terms of the agreement with the Secretary.

    (a) Under the agreement, the rural health clinic agrees to the 
following:
    (1) Maintaining compliance with conditions. The clinic agrees to 
maintain compliance with the conditions set forth in part 491 of this 
chapter and to report promptly to HCFA any failure to do so.
    (2) Charges to beneficiaries. The clinic agrees not to charge the 
beneficiary or any other person for items and services for which the 
beneficiary is entitled to have payment made under the provisions of 
this part (or for which the beneficiary would have been entitled if the 
rural health clinic had filed a request for payment in accordance with 
Sec. 410.165 of this chapter), except for any deductible or coinsurance 
amounts for which the beneficiary is liable under Sec. 405.2410.
    (3) Refunds to beneficiaries. (i) The clinic agrees to refund as 
promptly as possible any money incorrectly collected from beneficiaries 
or from someone on their behalf.
    (ii) As used in this section, money incorrectly collected means sums 
collected in excess of the amount for which the beneficiary was liable 
under Sec. 405.2410. It includes amounts collected at a time when the 
beneficiary was believed not to be entitled to Medicare benefits but:
    (A) The beneficiary is later determined to have been entitled to 
Medicare benefits; and
    (B) The beneficiary's entitlement period falls within the time the 
rural health clinic's agreement with the Secretary is in effect.

[[Page 155]]

    (4) Beneficiary treatment. (i) The clinic agrees to accept 
beneficiaries for care and treatment; and
    (ii) The clinic agrees not to impose any limitations on the 
acceptance of beneficiaries for care and treatment that it does not 
impose on all other persons.
    (b) Additional provisions. The agreement may contain any additional 
provisions that the Secretary finds necessary or desirable for the 
efficient and effective administration of the Medicare program.

[43 FR 8261, Mar. 1, 1978, as amended at 51 FR 41351, Nov. 14, 1986]



Sec. 405.2404  Terminations of agreements.

    (a) Termination by rural health clinic. (1) Notice to Secretary. If 
the clinic wishes to terminate its agreement it shall file with the 
Secretary a written notice stating the intended effective date of 
termination.
    (2) Action by the Secretary. (i) The Secretary may approve the date 
proposed by the clinic, or set a different date no later than 6 months 
after the date of the clinic's notice.
    (ii) The Secretary may approve a date which is less than 6 months 
after the date of notice if he determines that termination on that date 
would not:
    (A) Unduly disrupt the furnishing of services to the community 
serviced by the clinic; or
    (B) Otherwise interfere with the effective and efficient 
administration of the Medicare program.
    (3) Cessation of business. If a clinic ceases to furnish services to 
the community, that shall be deemed to be a voluntary termination of the 
agreement by the clinic, effective on the last day of business.
    (b) Termination by the Secretary. (1) Cause for termination. The 
Secretary may terminate an agreement if he determines that the rural 
health clinic:
    (i) No longer meets the conditions for certification under part 491 
of this chapter; or
    (ii) Is not in substantial compliance with the provisions of the 
agreement, the requirements of this subpart, any other applicable 
regulations of this part, or any applicable provisions of title XVIII of 
the Act; or
    (iii) Has undergone a change of ownership.
    (2) Notice of termination. The Secretary will give notice of 
termination to the rural health clinic at least 15 days before the 
effective date stated in the notice.
    (3) Appeal by the rural health clinic. A rural health clinic may 
appeal the termination of its agreement in accordance with the 
provisions set forth in part 498 of this chapter.
    (c) Effect of termination. Payment will not be available for rural 
health clinic services furnished on or after the effective date of 
termination.
    (d) Notice to the public. Prompt notice of the date and effect of 
termination shall be given to the public, through publication in local 
newspapers:
    (1) By the clinic, after the Secretary has approved or set a 
termination date; or
    (2) By the Secretary, when he has terminated the agreement.
    (e) Conditions for reinstatement after termination of agreement by 
the Secretary. When an agreement with a rural health clinic is 
terminated by the Secretary, the rural health clinic may not file 
another agreement to participate in the Medicare program unless the 
Secretary:
    (1) Finds that the reason for the termination of the prior agreement 
has been removed; and
    (2) Is assured that the reason for the termination will not recur.

[43 FR 8261, Mar. 1, 1978, as amended at 52 FR 22454, June 12, 1987]



Sec. 405.2410  Application of Part B deductible and coinsurance.

    (a) Application of deductible. (1) Medicare payment for rural health 
clinic services begins only after the beneficiary has incurred the 
deductible.
    (2) Medicare payment for services covered under the Federally 
qualified health center benefit is not subject to the usual Part B 
deductible.
    (b) Application of coinsurance. (1) The beneficiary is responsible 
for a coinsurance amount which cannot exceed 20 percent of the clinic's 
reasonable customary charge for the covered service; and
    (2)(i) The beneficiary's deductible and coinsurance liability, with 
respect to

[[Page 156]]

any one item or service furnished by the rural health clinic, may not 
exceed a reasonable amount customarily charged by the clinic for that 
particular item or service.
    (ii) For any one item or service furnished by a Federally qualified 
health center, the coinsurance liability may not exceed 20 percent of a 
reasonable amount customarily charged by the center for that particular 
item or service.

[57 FR 24976, June 12, 1992]



Sec. 405.2411  Scope of benefits.

    (a) Rural health clinic services reimbursable under this subpart 
are:
    (1) The physicians' services specified in Sec. 405.2412;
    (2) Services and supplies furnished as an incident to a physician's 
professional service;
    (3) The nurse practitioner or physician assistant services specified 
in Sec. 405.2414;
    (4) Services and supplies furnished as an incident to a nurse 
practitioner's or physician assistant's services; and
    (5) Visiting nurse services.
    (b) Rural health clinic services are reimbursable when furnished to 
a patient at the clinic, at a hospital or other medical facility, or at 
the patient's place of residence.



Sec. 405.2412  Physicians' services.

    (a) Physicians' services are professional services that are 
performed by a physician at the clinic or are performed away from the 
clinic by a physician whose agreement with the clinic provides that he 
or she will be paid by the clinic for such services.



Sec. 405.2413  Services and supplies incident to a physician's services.

    (a) Services and supplies incident to a physician's professional 
service are reimbursable under this subpart if the service or supply is:
    (1) Of a type commonly furnished in physicians' offices;
    (2) Of a type commonly rendered either without charge or included in 
the rural health clinic's bill;
    (3) Furnished as an incidental, although integral, part of a 
physician's professional services;
    (4) Furnished under the direct, personal supervision of a physician; 
and
    (5) In the case of a service, furnished by a member of the clinic's 
health care staff who is an employee of the clinic.
    (b) Only drugs and biologicals which cannot be self-administered are 
included within the scope of this benefit.



Sec. 405.2414  Nurse practitioner and physician assistant services.

    (a) Professional services are reimbursable under this subpart if:
    (1) Furnished by a nurse practitioner, physician assistant, nurse 
midwife, or specialized nurse practitioner who is employed by, or 
receives compensation from, the rural health clinic;
    (2) Furnished under the medical supervision of a physician;
    (3) Furnished in accordance with any medical orders for the care and 
treatment of a patient prepared by a physician;
    (4) They are of a type which the nurse practitioner, physician 
assistant, nurse midwife or specialized nurse practitioner who furnished 
the service is legally permitted to perform by the State in which the 
service is rendered; and
    (5) They would be covered if furnished by a physician.
    (b) The physician supervision requirement is met if the conditions 
specified in Sec. 491.8(b) of this chapter and any pertinent 
requirements of State law are satisfied.
    (c) The services of nurse practitioners, physician assistants, nurse 
midwives or specialized nurse practitioners are not covered if State law 
or regulations require that the services be performed under a 
physician's order and no such order was prepared.



Sec. 405.2415  Services and supplies incident to nurse practitioner and physician assistant services.

    (a) Services and supplies incident to a nurse practitioner's or 
physician assistant's services are reimbursable under this subpart if 
the service or supply is:
    (1) Of a type commonly furnished in physicians' offices;
    (2) Of a type commonly rendered either without charge or included in 
the rural health clinic's bill;

[[Page 157]]

    (3) Furnished as an incidental, although integral part of 
professional services furnished by a nurse practitioner, physician 
assistant, nurse midwife, or specialized nurse practitioner;
    (4) Furnished under the direct, personal supervision of a nurse 
practitioner, physician assistant, nurse midwife, specialized nurse 
practitioner or a physician; and
    (5) In the case of a service, furnished by a member of the clinic's 
health care staff who is an employee of the clinic.
    (b) The direct personal supervision requirement is met in the case 
of a nurse practitioner, physician assistant, nurse midwife, or 
specialized nurse practitioner only if such a person is permitted to 
supervise such services under the written policies governing the rural 
health clinic.
    (c) Only drugs and biologicals which cannot be self-administered are 
included within the scope of this benefit.



Sec. 405.2416  Visiting nurse services.

    (a) Visiting nurse services are covered if:
    (1) The rural health clinic is located in an area in which the 
Secretary has determined that there is a shortage of home health 
agencies;
    (2) The services are rendered to a homebound individual;
    (3) The services are furnished by a registered nurse, licensed 
practical nurse, or licensed vocational nurse who is employed by, or 
receives compensation for the services from the clinic; and
    (4) The services are furnished under a written plan of treatment 
that is:
    (i) Established and reviewed at least every 60 days by a supervising 
physician of the rural health clinic or established by a nurse 
practitioner, physician assistant, nurse midwife, or specialized nurse 
practitioner and reviewed at least every 60 days by a supervising 
physician; and
    (ii) Signed by the nurse practitioner, physician assistant, nurse 
midwife, specialized nurse practitioner, or the supervising physician of 
the clinic.
    (b) The nursing care covered by this section includes:
    (1) Services that must be performed by a registered nurse, licensed 
practical nurse, or licensed vocational nurse if the safety of the 
patient is to be assured and the medically desired results achieved; and
    (2) Personal care services, to the extent covered under Medicare as 
home health services. These services include helping the patient to 
bathe, to get in and out of bed, to exercise and to take medications.
    (c) This benefit does not cover household and housekeeping services 
or other services that would constitute custodial care.
    (d) For purposes of this section, homebound means an individual who 
is permanently or temporarily confined to his or her place of residence 
because of a medical or health condition. The individual may be 
considered homebound if he or she leaves the place of residence 
infrequently. For this purpose, ``place of residence'' does not include 
a hospital or long term care facility.



Sec. 405.2417  Visiting nurse services: Determination of shortage of agencies.

    A shortage of home health agencies exists if the Secretary 
determines that the rural health clinic:
    (a) Is located in a county, parish, or similar geographic area in 
which there is no participating home health agency or adequate home 
health services are not available to patients of the rural health 
clinic;
    (b) Has (or expects to have) patients whose permanent residences are 
not within the area serviced by a participating home health agency; or
    (c) Has (or expects to have) patients whose permanent residences are 
not within a reasonable traveling distance, based on climate and 
terrain, of a participating home health agency.

               Federally Qualified Health Center Services

    Source: 57 FR 24978, June 12, 1992, unless otherwise noted.



Sec. 405.2430  Basic requirements.

    (a) Filing procedures. (1) In response to a request from an entity 
that wishes to participate in the Medicare program, HCFA enters into an 
agreement with an entity when--

[[Page 158]]

    (i) PHS recommends that the entity qualifies as a Federally 
qualified health center;
    (ii) The Federally qualified health center assures HCFA that it 
meets the Federally qualified health center requirements specified in 
this subpart and part 491, as described in Sec. 405.2434(a); and
    (iii) The FQHC terminates other provider agreements, unless the FQHC 
assures HCFA that it is not using the same space, staff and resources 
simultaneously as a physician's office or another type of provider or 
supplier. A corporate entity may own other provider types as long as the 
provider types are distinct from the FQHC.
    (2) HCFA sends the entity a written notice of the disposition of the 
request.
    (3) When the requirement of paragraph (a)(1) of this section is 
satisfied, HCFA sends the entity two copies of the agreement. The entity 
must sign and return both copies of the agreement to HCFA.
    (4) If HCFA accepts the agreement filed by the Federally qualified 
health center, HCFA returns to the center one copy of the agreement with 
the notice of acceptance specifying the effective date (see 
Sec. 489.11), as determined under Sec. 405.2434.
    (b) Recommendations by PHS about Federally qualified health centers. 
(1) An entity must--
    (i) Meet the applicable requirements of the PHS Act, as specified in 
Sec. 405.2401(b); and
    (ii) Be recommended by PHS to HCFA as a Federally qualified health 
center.
    (2) The PHS notifies HCFA of entities that meet the requirements 
specified in Sec. 405.2401(b).
    (c) Provider-based and freestanding Federally qualified health 
centers. The requirements and benefits under Medicare for provider-based 
or freestanding Federally qualified health centers are the same, except 
that payment methodologies differ, as described in Sec. 405.2462.
    (d) Appeals. An entity is entitled to a hearing in accordance with 
part 498 of this chapter when HCFA fails to enter into an agreement with 
the entity.

[57 FR 24978, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]



Sec. 405.2434  Content and terms of the agreement.

    Under the agreement, the Federally qualified health center must 
agree to the following:
    (a) Maintain compliance with the requirements. (1) The Federally 
qualified health center must agree to maintain compliance with the 
Federally qualified health center requirements set forth in this subpart 
and part 491, except that the provisions of Sec. 491.3 do not apply.
    (2) Centers must promptly report to HCFA any changes that result in 
noncompliance with any of these requirements.
    (b) Effective date of agreement. (1) Except as specified in 
paragraph (b)(2) of this section, the effective date of the agreement is 
the date HCFA accepts the signed agreement, which assures that all 
Federal requirements are met.
    (2) For facilities that met all requirements on October 1, 1991, the 
effective date of the agreement can be October 1, 1991.
    (c) Charges to beneficiaries. (1) The beneficiary is responsible for 
payment of a coinsurance amount which is 20 percent of the amount of 
Part B payment made to the Federally qualified health center for the 
covered services. There is no coinsurance for a second or third opinion 
obtained in accordance with section 1164 of the Act or for pneumococcal 
vaccine and its administration.
    (2) The beneficiary is responsible for blood deductible expenses, as 
specified in Sec. 410.161.
    (3) The Federally qualified health center agrees not to charge the 
beneficiary (or any other person acting on behalf of a beneficiary) for 
any Federally qualified health center services for which the beneficiary 
is entitled to have payment made on his or her behalf by the Medicare 
program (or for which the beneficiary would have been entitled if the 
Federally qualified health center had filed a request for payment in 
accordance with Sec. 410.165 of this chapter), except for coinsurance 
amounts.
    (4) The Federally qualified health center may charge the beneficiary 
for items and services that are not Federally qualified health center 
services.

[[Page 159]]

However, if the item or service is covered under Part B of Medicare, and 
the Federally qualified health center agrees to receive Part B payment 
under the assignment method, the Federally qualified health center may 
not charge the beneficiary more than 20 percent of the Part B payment.
    (d) Refunds to beneficiaries. (1) The Federally qualified health 
center must agree to refund as promptly as possible any money 
incorrectly collected from Medicare beneficiaries or from someone on 
their behalf.
    (2) As used in this section, ``money incorrectly collected'' means 
any amount for covered services that is greater than the amount for 
which the beneficiary was liable because of the coinsurance requirements 
specified in part 410, subpart E.
    (3) Amounts also are considered incorrectly collected if the 
Federally qualified health center believed the beneficiary was not 
entitled to Medicare benefits but--
    (i) The beneficiary was later determined to have been so entitled;
    (ii) The beneficiary's entitlement period fell within the time the 
Federally qualified health center's agreement with HCFA was in effect; 
and
    (iii) The amounts exceed the beneficiary's coinsurance liability.
    (e) Treatment of beneficiaries. (1) The Federally qualified health 
center must agree to accept Medicare beneficiaries for care and 
treatment.
    (2) The Federally qualified health center may not impose any 
limitations with respect to care and treatment of Medicare beneficiaries 
that it does not also impose upon all other persons seeking care and 
treatment from the Federally qualified health center. Failure to comply 
with this requirement is a cause for termination of the Federally 
qualified health center's agreement with HCFA in accordance with 
Sec. 405.2436(d).
    (3) If the Federally qualified health center does not furnish 
treatment for certain illnesses and conditions to patients who are not 
Medicare beneficiaries, it need not furnish such treatment to Medicare 
beneficiaries.



Sec. 405.2436  Termination of agreement.

    (a) Termination by Federally qualified health center. The Federally 
qualified health center may terminate its agreement by--
    (1) Filing with HCFA a written notice stating its intention to 
terminate the agreement; and
    (2) Notifying HCFA of the date on which the Federally qualified 
health center requests that the termination take effect.
    (b) Effective date. (1) Upon receiving a Federally qualified health 
center's notice of intention to terminate the agreement, HCFA will set a 
date upon which the termination takes effect. This effective date may 
be--
    (i) The date proposed by the Federally qualified health center in 
its notice of intention to terminate, if that date is acceptable to 
HCFA; or
    (ii) Except as specified in paragraph (2) of this section, a date 
set by HCFA, which is no later than 6 months after the date HCFA 
receives the Federally qualified health center's notice of intention to 
terminate.
    (2) The effective date of termination may be less than 6 months 
following HCFA's receipt of the Federally qualified health center's 
notice of intention to terminate if HCFA determines that termination on 
such a date would not--
    (i) Unduly disrupt the furnishing of Federally qualified health 
center services to the community; or
    (ii) Otherwise interfere with the effective and efficient 
administration of the Medicare program.
    (3) The termination is effective at the end of the last day of 
business as a Federally qualified health center.
    (c) Termination by HCFA. (1) HCFA may terminate an agreement with a 
Federally qualified health center if it finds that the Federally 
qualified health center--
    (i) No longer meets the requirements specified in this subpart; or
    (ii) Is not in substantial compliance with--
    (A) The provisions of the agreement; or
    (B) The requirements of this subpart, any other applicable 
regulations of this part, or any applicable provisions of title XVIII of 
the Act.

[[Page 160]]

    (2) Notice by HCFA. HCFA will notify the Federally qualified health 
center in writing of its intention to terminate an agreement at least 15 
days before the effective date stated in the written notice.
    (3) Appeal. A Federally qualified health center may appeal HCFA's 
decision to terminate the agreement in accordance with part 498 of this 
chapter.
    (d) Effect of termination. When a Federally qualified health 
center's agreement is terminated whether by the Federally qualified 
health center or HCFA, payment will not be available for Federally 
qualified health center services furnished on or after the effective 
date of termination.



Sec. 405.2440  Conditions for reinstatement after termination by HCFA.

    When HCFA has terminated an agreement with a Federally qualified 
health center, HCFA will not enter into another agreement with the 
Federally qualified health center to participate in the Medicare program 
unless HCFA--
    (a) Finds that the reason for the termination no longer exists; and
    (b) Is assured that the reason for the termination of the prior 
agreement will not recur.



Sec. 405.2442  Notice to the public.

    (a) When the Federally qualified health center voluntarily 
terminates the agreement and an effective date is set for the 
termination, the Federally qualified health center must notify the 
public prior to a prospective effective date or on the actual day that 
business ceases, if no prospective date of termination has been set, 
through publication in at least one newspaper in general circulation in 
the area serviced by the Federally qualified health center of the--
    (1) Effective date of termination of the provision of services; and
    (2) Effect of termination of the agreement.
    (b) When HCFA terminates the agreement, HCFA will notify the public 
through publication in at least one newspaper in general circulation in 
the Federally qualified health center's service area.



Sec. 405.2444  Change of ownership.

    (a) What constitutes change of ownership--(1) Incorporation. The 
incorporation of an unincorporated FQHC constitutes change of ownership.
    (2) Merger. The merger of the center corporation into another 
corporation, or the consolidation of two or more corporations, one of 
which is the center corporation, resulting in the creation of a new 
corporation, constitutes a change of ownership. (The merger of another 
corporation into the center corporation does not constitute change of 
ownership.)
    (3) Leasing. The lease of all or part of an entity constitutes a 
change of ownership of the leased portion.
    (b) Notice to HCFA. A center which is contemplating or negotiating 
change of ownership must notify HCFA.
    (c) Assignment of agreement. When there is a change of ownership as 
specified in paragraph (a) of this section, the agreement with the 
existing center is automatically assigned to the new owner if it 
continues to meet the conditions to be a Federally qualified health 
center.
    (d) Conditions that apply to assigned agreements. An assigned 
agreement is subject to all applicable statutes and regulations and to 
the terms and conditions under which it was originally issued including, 
but not limited to, the following:
    (1) Compliance with applicable health and safety standards.
    (2) Compliance with the ownership and financial interest disclosure 
requirements of part 420, subpart C of this subchapter.



Sec. 405.2446  Scope of services.

    (a) For purposes of this section, the terms rural health clinic and 
clinic when they appear in the cross references in paragraph (b) of this 
section also mean Federally qualified health centers.
    (b) FQHC services that are paid for under this subpart are 
outpatient services that include the following:
    (1) Physician services specified in Sec. 405.2412.
    (2) Services and supplies furnished as an incident to a physician's 
professional services, as specified in Sec. 405.2413.
    (3) Nurse practitioner or physician assistant services specified in 
Sec. 405.2414.

[[Page 161]]

    (4) Services and supplies furnished as an incident to a nurse 
practitioner or physician assistant services, as specified in 
Sec. 405.2415.
    (5) Clinical psychologist and clinical social worker services 
specified in Sec. 405.2450.
    (6) Services and supplies furnished as an incident to a clinical 
psychologist or clinical social worker services, as specified in 
Sec. 405.2452.
    (7) Visiting nurse services specified in Sec. 405.2416.
    (8) Nurse-midwife services specified in Sec. 405.2401.
    (9) Preventive primary services specified in Sec. 405.2448 of this 
subpart.
    (c) Federally qualified health center services are covered when 
provided in outpatient settings only, including a patient's place of 
residence, which may be a skilled nursing facility or a nursing facility 
or other institution used as a patient's home.
    (d) Federally qualified health center services are not covered in a 
hospital, as defined in section 1861(e)(1) of the Act.

[57 FR 24979, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]



Sec. 405.2448  Preventive primary services.

    (a) Preventive primary services are those health services that--
    (1) A center is required to provide as preventive primary health 
services under section 329, 330, and 340 of the Public Health Service 
Act;
    (2) Are furnished by or under the direct supervision of a nurse 
practitioner, physician assistant, nurse midwife, specialized nurse 
practitioner, clinical psychologist, clinical social worker, or a 
physician;
    (3) In the case of a service, are furnished by a member of the 
center's health care staff who is an employee of the center or by a 
physician under arrangements with the center; and
    (4) Except as specifically provided in section 1861(s) of the Act, 
include only drugs and biologicals that cannot be self-administered.
    (b) Preventive primary services which may be paid for when provided 
by Federally qualified health centers are the following:
    (1) Medical social services.
    (2) Nutritional assessment and referral.
    (3) Preventive health education.
    (4) Children's eye and ear examinations.
    (5) Prenatal and post-partum care.
    (6) Perinatal services.
    (7) Well child care, including periodic screening.
    (8) Immunizations, including tetanus-diptheria booster and influenza 
vaccine.
    (9) Voluntary family planning services.
    (10) Taking patient history.
    (11) Blood pressure measurement.
    (12) Weight.
    (13) Physical examination targeted to risk.
    (14) Visual acuity screening.
    (15) Hearing screening.
    (16) Cholesterol screening.
    (17) Stool testing for occult blood.
    (18) Dipstick urinalysis.
    (19) Risk assessment and initial counseling regarding risks.
    (20) Tuberculosis testing for high risk patients.
    (21) For women only.
    (i) Clinical breast exam.
    (ii) Referral for mammography; and
    (iii) Thyroid function test.
    (c) Preventive primary services do not include group or mass 
information programs, health education classes, or group education 
activities, including media productions and publications.
    (d) Screening mammography is not considered a Federally qualified 
health center service, but may be provided at a Federally qualified 
health center if the center meets the requirements applicable to that 
service specified in Sec. 410.34 of this subchapter. Payment is made 
under applicable Medicare requirements.
    (e) Preventive primary services do not include eyeglasses, hearing 
aids, or preventive dental services.

[57 FR 24980, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]



Sec. 405.2450  Clinical psychologist and clinical social worker services.

    (a) For clinical psychologist or clinical social worker professional 
services to be payable under this subpart, the services must be--

[[Page 162]]

    (1) Furnished by an individual who owns, is employed by, or 
furnishes services under contract to the FQHC;
    (2) Of a type that the clinical psychologist or clinical social 
worker who furnishes the services is legally permitted to perform by the 
State in which the service is furnished;
    (3) Performed by a clinical social worker or clinical psychologist 
who is legally authorized to perform such services under State law or 
the State regulatory mechanism provided by the law of the State in which 
such services are performed; and
    (4) Covered if furnished by a physician.
    (b) If State law prescribes a physician supervision requirement, it 
is met if the conditions specified in Sec. 491.8(b) of this chapter and 
any pertinent requirements of State law are satisfied.
    (c) The services of clinical psychologists or clinical social 
workers are not covered if State law or regulations require that the 
services be performed under a physician's order and no such order was 
prepared.

[57 FR 24980, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]



Sec. 405.2452  Services and supplies incident to clinical psychologist and clinical social worker services.

    (a) Services and supplies incident to a clinical psychologist's or 
clinical social worker's services are reimbursable under this subpart if 
the service or supply is--
    (1) Of a type commonly furnished in a physician's office;
    (2) Of a type commonly furnished either without charge or included 
in the Federally qualified health center's bill;
    (3) Furnished as an incidental, although integral part of 
professional services furnished by a clinical psychologist or clinical 
social worker;
    (4) Furnished under the direct, personal supervision of a clinical 
psychologist, clinical social worker or physician; and
    (5) In the case of a service, furnished by a member of the center's 
health care staff who is an employee of the center.
    (b) The direct personal supervision requirement in paragraph (a)(4) 
of this section is met only if the clinical psychologist or clinical 
social worker is permitted to supervise such services under the written 
policies governing the Federally qualified health center.

 Payment for Rural Health Clinic and Federally Qualified Health Center 
                                Services

    Source: 57 FR 24976, 24977, June 12, 1992, unless otherwise noted.



Sec. 405.2460  Applicability of general payment exclusions.

    The payment conditions, limitations, and exclusions set out in 
subpart C of this part, part 410 and part 411 of this chapter are 
applicable to payment for services provided by rural health clinics and 
Federally qualified health centers, except that preventive primary 
services, as defined in Sec. 405.2448, are covered in Federally 
qualified health centers and not excluded by the provisions of section 
1862(a) of the Act.



Sec. 405.2462  Payment for rural health clinic and Federally qualified health center services.

    (a) Payment to provider-based rural health clinics and Federally 
qualified health centers. A rural health clinic or Federally qualified 
health center is paid in accordance with parts 405 and 413 of this 
subchapter, as applicable, if:
    (1) The clinic or center is an integral and subordinate part of a 
hospital, skilled nursing facility or home health agency participating 
in Medicare (i.e., a provider of services); and
    (2) The clinic or center is operated with other departments of the 
provider under common licensure, governance and professional 
supervision.
    (b) Payment to independent rural health clinics and freestanding 
Federally qualified health centers. (1) All other clinics and centers 
will be paid on the basis of an all-inclusive rate for each beneficiary 
visit for covered services. This rate will be determined by the 
intermediary, in accordance with this subpart and general instructions 
issued by HCFA.
    (2) The amount payable by the intermediary for a visit will be 
determined in accordance with paragraph (b)(3) and (4) of this section.
    (3) Federally qualified health centers. For Federally qualified 
health center

[[Page 163]]

visits, Medicare will pay 80 percent of the all-inclusive rate since no 
deductible is applicable to Federally qualified health center services.
    (4) Rural health clinics. (i) If the deductible has been fully met 
by the beneficiary prior to the rural health clinic visit, Medicare pays 
80 percent of the all-inclusive rate.
    (ii) If the deductible has not been fully met by the beneficiary 
before the visit, and the amount of the clinic's reasonable customary 
charge for the services that is applied to the deductible is--
    (A) Less than the all-inclusive rate, the amount applied to the 
deductible will be subtracted from the all-inclusive rate and 80 percent 
of the remainder, if any, will be paid to the clinic;
    (B) Equal to or exceeds the all-inclusive rate, no payment will be 
made to the clinic.
    (5) To receive payment, the clinic or center must follow the payment 
procedures specified in section 410.165 of this chapter.
    (6) Payment for treatment of mental psychoneurotic or personality 
disorders is subject to the limitations on payment in Sec. 410.155(c).



Sec. 405.2463  What constitutes a visit.

    (a) Visit. (1) A visit is a face-to-face encounter between a clinic 
or center patient and a physician, physician assistant, nurse 
practitioner, nurse-midwife, or visiting nurse.
    (2) For FQHCs, a visit also means a face-to-face encounter between a 
patient and a qualified clinical psychologist or clinical social worker.
    (3) Encounters with more than one health professional and multiple 
encounters with the same health professional that take place on the same 
day and at a single location constitute a single visit, except when one 
of the following conditions exist:
    (i) After the first encounter, the patient suffers illness or injury 
requiring additional diagnosis or treatment.
    (ii) For FQHCs, the patient has a medical visit and an other health 
visit, as defined in paragraphs (b) and (c) of this section.
    (4) Payment. (i) Medicare pays for two visits per day when the 
conditions in paragraph (a)(3) of this section are met.
    (ii) In all other cases, payment is limited to one visit per day.
    (b) Medical visit. For purposes of paragraph (a)(3) of this section, 
a medical visit is a face-to-face encounter between an FQHC patient and 
a physician, physician assistant, nurse practitioner, nurse-midwife, or 
visiting nurse.
    (c) Other health visit. For purposes of paragraph (a)(3) of this 
section, an other health visit is a face-to-face encounter between an 
FQHC patient and a clinical psychologist, clinical social worker, or 
other health professional for mental health services.

[61 FR 14657, Apr. 3, 1996]



Sec. 405.2464  All-inclusive rate.

    (a) Determination of rate. (1) An all-inclusive rate is determined 
by the intermediary at the beginning of the reporting period.
    (2) The rate is determined by dividing the estimated total allowable 
costs by estimated total visits for rural health clinic or Federally 
qualified health center services.
    (3) The rate determination is subject to any tests of reasonableness 
that may be established in accordance with this subpart.
    (b) Adjustment of rate. (1) The intermediary, during each reporting 
period, periodically reviews the rate to assure that payments 
approximate actual allowable costs and visits for rural health clinic or 
Federally qualified health center services and adjusts the rate if:
    (i) There is a significant change in the utilization of clinic or 
center services;
    (ii) Actual allowable costs vary materially from the clinic or 
center's allowable costs; or
    (iii) Other circumstances arise which warrant an adjustment.
    (2) The clinic or center may request the intermediary to review the 
rate to determine whether adjustment is required.



Sec. 405.2466  Annual reconciliation.

    (a) General. Payments made to a rural health clinic or a Federally 
qualified health center during a reporting period are subject to 
reconciliation to

[[Page 164]]

assure that those payments do not exceed or fall short of the allowable 
costs attributable to covered services furnished to Medicare 
beneficiaries during that period.
    (b) Calculation of reconciliation. (1) The total reimbursement 
amount due the clinic or center for covered services furnished to 
Medicare beneficiaries is based on the report specified in 
Sec. 405.2470(c)(2) and is calculated by the intermediary as follows:
    (i) The average cost per visit is calculated by dividing the total 
allowable cost incurred for the reporting period by total visits for 
rural health clinic or Federally qualified health center services 
furnished during the period. The average cost per visit is subject to 
tests of reasonableness which may be established in accordance with this 
subpart.
    (ii) The total cost of rural health clinic or Federally qualified 
health center services furnished to Medicare beneficiaries is calculated 
by multiplying the average cost per visit by the number of visits for 
covered rural health clinic or Federally qualified health center 
services by beneficiaries.
    (iii) For rural health clinics, the total reimbursement due the 
clinic is 80 percent of the amount calculated by subtracting the amount 
of deductible incurred by beneficiaries that is attributable to rural 
health clinic services from the cost of these services. The 
reimbursement computation for Federally qualified health centers does 
not include a reduction related to the deductible because Federally 
qualified health center services are not subject to a deductible.
    (iv) For rural health clinics and FQHCs, payment for pneumococcal 
and influenza vaccine and their administration is 100 percent of 
Medicare reasonable cost.
    (2) The total reimbursement amount due is compared with total 
payments made to the clinic or center for the reporting period, and the 
difference constitutes the amount of the reconciliation.
    (c) Notice of program reimbursement. The intermediary sends written 
notice to the clinic or center:
    (1) Setting forth its determination of the total reimbursement 
amount due the clinic or center for the reporting period and the amount, 
if any, of the reconciliation; and
    (2) Informing the clinic or center of its right to have the 
determination reviewed at a hearing under the procedures set forth in 
subpart R of this part.
    (d) Payment of reconciliation amount--(1) Underpayments. If the 
total reimbursement due the clinic or center exceeds the payments made 
for the reporting period, the intermediary makes a lump-sum payment to 
the clinic or center to bring total payments into agreement with total 
reimbursement due the clinic or center.
    (2) Overpayments. If the total payments made to a clinic or center 
for the reporting period exceed the total reimbursement due the clinic 
or center for the period, the intermediary arranges with the clinic or 
center for repayment through a lump-sum refund, or, if that poses a 
hardship for the clinic or center, through offset against subsequent 
payments or a combination of offset and refund. The repayment must be 
completed as quickly as possible, generally within 12 months from the 
date of the notice of program reimbursement. A longer repayment period 
may be agreed to by the intermediary if the intermediary is satisfied 
that unusual circumstances exist which warrant a longer period.

[57 FR 24976, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]



Sec. 405.2468  Allowable costs.

    (a) Applicability of general Medicare principles. In determining 
whether and to what extent a specific type or item of cost is allowable, 
such as interest, depreciation, bad debts and owner compensation, the 
intermediary applies the principles for reimbursement of provider costs, 
as set forth in part 413 of this subchapter.
    (b) Typical rural health clinic and Federally qualified health 
center costs. The following types and items of cost are included in 
allowable costs to the extent that they are covered and reasonable:
    (1) Compensation for the services of a physician, physician 
assistant, nurse practitioner, nurse-midwife, visiting nurse, qualified 
clinical psychologist,

[[Page 165]]

and clinical social worker who owns, is employed by, or furnishes 
services under contract to an FQHC. (RHCs are not paid for services 
furnished by contracted individuals other than physicians.)
    (2) Compensation for the duties that a supervising physician is 
required to perform under the agreement specified in Sec. 491.8 of this 
chapter.
    (3) Costs of services and supplies incident to the services of a 
physician, physician assistant, nurse practitioner, nurse-midwife, 
qualified clinical psychologist, or clinical social worker.
    (4) Overhead costs, including clinic or center administration, costs 
applicable to use and maintenance of the entity, and depreciation costs.
    (5) Costs of services purchased by the clinic or center.
    (c) Tests of reasonableness for rural health clinic cost and 
utilization. Tests of reasonableness authorized by sections 1833(a) and 
1861(v)(1)(A) of the Act may be established by HCFA or the carrier with 
respect to direct or indirect overall costs, costs of specific items and 
services, or costs of groups of items and services. Those tests include, 
but are not limited to, screening guidelines and payment limitations.
    (d) Screening guidelines. (1) Costs in excess of amounts established 
by the guidelines are not included unless the clinic or center provides 
reasonable justification satisfactory to the intermediary.
    (2) Screening guidelines are used to assess the costs of services, 
including the following:
    (i) Compensation for the professional and supervisory services of 
physicians and for the services of physician assistants, nurse 
practitioners, and nurse-midwives.
    (ii) Services of physicians, physician assistants, nurse 
practitioners, nurse-midwives, visiting nurses, qualified clinical 
psychologists, and clinical social workers.
    (iii) The level of administrative and general expenses.
    (iv) Staffing (for example, the ratio of other clinic or center 
personnel to physicians, physician assistants, and nurse practitioners).
    (v) The reasonableness of payments for services purchased by the 
clinic or center, subject to the limitation that the costs of physician 
services purchased by the clinic or center may not exceed amounts 
determined under the applicable provisions of subpart E of part 405 or 
part 415 of this chapter.
    (e) Payment limitations. Limits on payments may be set by HCFA, on 
the basis of costs estimated to be reasonable for the provision of such 
services.
    (f) Graduate medical education. (1) Effective for that portion of 
cost reporting periods occurring on or after January 1, 1999, if an RHC 
or an FQHC incurs ``all or substantially all'' of the costs for the 
training program in the nonhospital setting as defined in Sec. 413.86(b) 
of this chapter, the RHC or FQHC may receive direct graduate medical 
education payment for those residents.
    (2) Direct graduate medical education costs are not included as 
allowable cost under Sec. 405.2466(b)(1)(i); and therefore, are not 
subject to the limit on the all-inclusive rate for allowable costs.
    (3) Allowable graduate medical education costs must be reported on 
the RHC's or the FQHC's cost report under a separate cost center.
    (4) Allowable graduate medical education costs are non-reimbursable 
if payment for these costs are received from a hospital or a 
Medicare+Choice organization.
    (5) Allowable direct graduate medical education costs under 
paragraphs (f)(6) and (f)(7)(i) of this section, are subject to 
reasonable cost principles under part 413 and the reasonable 
compensation equivalency limits in Secs. 415.60 and 415.70 of this 
chapter.
    (6) The allowable direct graduate medical education costs are those 
costs incurred by the nonhospital site for the educational activities 
associated with patient care services of an approved program, subject to 
the redistribution and community support principles in Sec. 413.85(c).
    (i) The following costs are allowable direct graduate medical 
education costs to the extent that they are reasonable--
    (A) The costs of the residents' salaries and fringe benefits 
(including travel and lodging expenses where applicable).

[[Page 166]]

    (B) The portion of teaching physicians' salaries and fringe benefits 
that are related to the time spent teaching and supervising residents.
    (C) Facility overhead costs that are allocated to direct graduate 
medical education.
    (ii) The following costs are not allowable graduate medical 
education costs--
    (A) Costs associated with training, but not related to patient care 
services.
    (B) Normal operating and capital-related costs.
    (C) The marginal increase in patient care costs that the RHC or FQHC 
experiences as a result of having an approved program.
    (D) The costs associated with activities described in Sec. 413.85(d) 
of this chapter.
    (7) Payment is equal to the product of--
    (i) The RHC's or the FQHC's allowable direct graduate medical 
education costs; and
    (ii) Medicare's share, which is equal to the ratio of Medicare 
visits to the total number of visits (as defined in Sec. 405.2463).
    (8) Direct graduate medical education payments to RHCs and FQHCs 
made under this section are made from the Federal Supplementary Medical 
Insurance Trust Fund.

[43 FR 8261, Mar. 1, 1978. Redesignated and amended at 57 FR 24977, June 
12, 1992; 60 FR 63176, Dec. 8, 1995; 61 FR 14658, Apr. 3, 1996; 63 FR 
41002, July 31, 1998]



Sec. 405.2470  Reports and maintenance of records.

    (a) Maintenance and availability of records. The rural health clinic 
or Federally qualified health center must:
    (1) Maintain adequate financial and statistical records, in the form 
and containing the data required by HCFA, to allow the intermediary to 
determine payment for covered services furnished to Medicare 
beneficiaries in accordance with this subpart;
    (2) Make the records available for verification and audit by HHS or 
the General Accounting Office;
    (3) Maintain financial data on an accrual basis, unless it is part 
of a governmental institution that uses a cash basis of accounting. In 
the latter case, appropriate depreciation on capital assets is allowable 
rather than the expenditure for the capital asset.
    (b) Adequacy of records. (1) The intermediary may suspend 
reimbursement if it determines that the clinic or center does not 
maintain records that provide an adequate basis to determine payments 
under Medicare.
    (2) The suspension continues until the clinic or center demonstrates 
to the intermediary's satisfaction that it does, and will continue to, 
maintain adequate records.
    (c) Reporting requirements--(1) Initial report. At the beginning of 
its initial reporting period, the clinic or center must submit an 
estimate of budgeted costs and visits for rural health clinic or 
Federally qualified health center services for the reporting period, in 
the form and detail required by HCFA, and such other information as HCFA 
may require to establish the payment rate.
    (2) Annual reports. Within 90 days after the end of its reporting 
period, the clinic or center must submit, in such form and detail as may 
be required by HCFA, a report of:
    (i) Its operations, including the allowable costs actually incurred 
for the period and the actual number of visits for rural health clinic 
or Federally qualified health center services furnished during the 
period; and
    (ii) The estimated costs and visits for rural health clinic services 
or Federally qualified health center services for the succeeding 
reporting period and such other information as HCFA may require to 
establish the payment rate.
    (3) Late reports. If the clinic or center does not submit an 
adequate annual report on time, the intermediary may reduce or suspend 
payments to preclude excess payment to the clinic or center.
    (4) Inadequate reports. If the clinic or center does not furnish a 
report or furnishes a report that is inadequate for the intermediary to 
make a determination of program payment, HCFA may deem all payments for 
the reporting period to be overpayments.
    (5) Postponement of due date. For good cause shown by the clinic or 
center, the intermediary may, with HCFA's approval, grant a 30-day 
postponement of the due date for the annual report.

[[Page 167]]

    (6) Reports following termination of agreement or change of 
ownership. The report from a clinic or center which voluntarily or 
involuntarily ceases to participate in the Medicare program or 
experiences a change in ownership (see Secs. 405.2436-405.2438) is due 
no later than 45 days following the effective date of the termination of 
agreement or change of ownership.



Sec. 405.2472  Beneficiary appeals.

    A beneficiary may request a hearing by an intermediary (subject to 
the limitations and conditions set forth in subpart H of this part) if:
    (a) The beneficiary is dissatisfied with an intermediary's 
determination denying a request for payment made on his or her behalf by 
a rural health clinic or Federally qualified health center; or
    (b) The beneficiary is dissatisfied with the amount of payment; or
    (c) The beneficiary believes the request for payment is not being 
acted upon with reasonable promptness.

[43 FR 8261, Mar. 1, 1978. Redesignated and amended at 57 FR 24978, June 
12, 1992]



PART 406--HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT--Table of Contents




                      Subpart A--General Provisions

Sec.
406.1  Statutory basis.
406.2  Scope.
406.3  Definitions.
406.5  Basis of eligibility and entitlement.
406.6  Application or enrollment for hospital insurance.
406.7  Forms to apply for entitlement under Medicare Part A.

         Subpart B--Hospital Insurance Without Monthly Premiums

406.10  Individual age 65 or over who is entitled to social security or 
          railroad retirement benefits, or who is eligible for social 
          security benefits.
406.11  Individual age 65 or over who is not eligible as a social 
          security or railroad retirement benefits beneficiary, or on 
          the basis of government employment.
406.12  Individual under age 65 who is entitled to social security or 
          railroad retirement disability benefits.
406.13  Individual who has end-stage renal disease.
406.15  Special provisions applicable to Medicare qualified government 
          employment.

                  Subpart C--Premium Hospital Insurance

406.20  Basic requirements.
406.21  Individual enrollment.
406.22  Effect of month of enrollment on entitlement.
406.24  Special enrollment period.
406.26  Enrollment under State buy-in.
406.28  End of entitlement.
406.32  Monthly premiums.
406.33  Determination of months to be counted for premium increase: 
          Enrollment.
406.34  Determination of months to be counted for premium increase: 
          Reenrollment.
406.38  Prejudice to enrollment rights because of Federal Government 
          error.

  Subpart D--Special Circumstances That Affect Entitlement to Hospital 
                                Insurance

406.50  Nonpayment of benefits on behalf of certain aliens.
406.52  Conviction of certain offenses.

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

    Source: 48 FR 12536, Mar. 25, 1983, unless otherwise noted. 
Redesignated at 51 FR 41338, Nov. 14, 1986.



                      Subpart A--General Provisions



Sec. 406.1  Statutory basis.

    Sections 226, 226A, 1818 and 1818A of the Social Security Act and 
section 103 of Public Law 89-97 establish the conditions for entitlement 
to hospital insurance benefits. Sections 202 (t) and (u) of the Act 
specify limitations that apply to certain aliens and to persons 
convicted of certain offenses.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 56 FR 38078, Aug. 12, 1991]



Sec. 406.2  Scope.

    Subparts A through D of this part specify the conditions of 
eligibility for hospital insurance and set forth certain specific 
conditions that affect entitlement to benefits. Hospital insurance is 
authorized under Part A of title XVIII and is also referred to as 
Medicare Part A. It includes inpatient hospital care, posthospital SNF 
care, home health services, and hospice care.

[48 FR 56026, Dec. 16, 1983, as amended at 50 FR 33033, Aug. 16, 1985. 
Redesignated and amended at 51 FR 41338, Nov. 14, 1986]

[[Page 168]]



Sec. 406.3  Definitions.

    First month of eligibility means the first month in which an 
individual meets all the requirements for entitlement to hospital 
insurance except application or enrollment if that is required.
    First month of entitlement means the first month for which the 
individual meets all the requirements for entitlement to Part A 
benefits.
    Insured individual means an individual who has the number of 
quarters of coverage required for monthly social security benefits.
    Quarter of coverage means a calendar quarter that is counted toward 
the number of covered quarters required to make the individual eligible 
for monthly social security benefits. A quarter is counted if during 
that quarter (or that calendar year) the individual earned a required 
minimum amount of money. (For details, see 20 CFR part 404, subpart B.)



Sec. 406.5  Basis of eligibility and entitlement.

    (a) Hospital insurance without premiums. Hospital insurance is 
available to most individuals without payment of a premium if they:
    (1) Are age 65 or over, or
    (2) Have received social security or railroad retirement disability 
benefits for 25 months; or
    (3) Have end-stage renal disease. Subpart B of this part explains 
the requirements such individuals must meet to obtain hospital insurance 
without premiums.
    (b) Premium hospital insurance. Many individuals who are age 65 or 
over, but do not meet the requirements set forth in subpart B of this 
part, and certain individuals under age 65, may obtain the benefits by 
paying a premium. Section 406.20 of this part explains the requirements 
individuals must meet to obtain premium hospital insurance.

[48 FR 12536, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
56 FR 38078, Aug. 12, 1991]



Sec. 406.6  Application or enrollment for hospital insurance.

    (a) Basic provision. In most cases, eligibility for Medicare Part A 
is a result of entitlement to monthly social security or railroad 
retirement cash benefits or eligibility for monthly social security cash 
benefits. This section specifies the individuals who need not file an 
application to become entitled to hospital insurance, those who must 
file an application, and those who must enroll.
    (b) Individuals who need not file an application for hospital 
insurance. An individual who meets any of the following conditions need 
not file an application for hospital insurance:
    (1) Is under age 65 and has been entitled, for more than 24 months, 
to monthly social security or railroad retirement benefits based on 
disability.
    (2) At the time of attainment of age 65, is entitled to monthly 
social security or railroad retirement benefits.
    (3) Establishes entitlement to monthly social security or railroad 
retirement benefits at any time after attaining age 65.
    (c) Individuals who must file an application for hospital insurance. 
An individual must file an application for hospital insurance if he or 
she seeks entitlement to hospital insurance on the basis of--
    (1) The transitional provisions set forth in Sec. 406.11;
    (2) Deemed entitlement to disabled widow's or widower's benefit 
under certain circumstances as provided in Sec. 406.12;
    (3) A diagnosis of end-stage renal disease, as specified in 
Sec. 406.13;
    (4) Effective January 1, 1981, eligibility for social security cash 
benefits, as specified in Sec. 406.10(a)(3), if the individual has 
attained age 65 without applying for those benefits; or
    (5) The special provisions applicable to government employment as 
set forth in Sec. 406.15.
    (d) When application is deemed to be filed. (1) An application based 
on the transitional provisions or on ESRD is deemed to be filed in the 
first month of eligibility if it is filed not more than 3 months before 
the first month, and is retroactive to that month if filed within 12 
months after the first month. An application filed more than 12 months 
after the first month of eligibility is retroactive to the 12th month 
before the month it is filed.

[[Page 169]]

    (2) An application for deemed entitlement to disabled widow's or 
widower's benefits, that is filed before the first month in which the 
individual meets all conditions of entitlement for this benefit, will be 
deemed a valid application if those conditions are met before an initial 
determination, reconsideration, or hearing decision is made on the 
application. If the conditions are met after the date of any hearing 
decision, a new application will have to be filed. An application 
validly filed within 12 months after the first month of eligibility is 
retroactive to that first month. If filed more than 12 months after that 
first month, it is retroactive to the 12th month before the month of 
filing.
    (3) Effective June 8, 1980, an application based on eligibility for 
social security benefits at or after age 65, that is filed before the 
first month in which the individual meets all eligibility conditions for 
this benefit, will be deemed a valid application if those conditions are 
met before an initial determination, reconsideration, or hearing 
decision is made on the application. If the conditions are met after the 
date of any hearing decision, a new application will have to be filed.
    (4) Effective March 1, 1981, an application under Sec. 406.10 that 
is validly filed within 6 months after the first month of eligibility is 
retroactive to that first month. If filed more than 6 months after that 
first month, it is retroactive to the 6th month before the month of 
filing.
    (e) Individuals who must enroll for hospital insurance. An 
individual who must pay a monthly premium for hospital insurance must 
enroll in accordance with the procedures set forth in Sec. 406.21.

[48 FR 12536, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
53 FR 47202, Nov. 22, 1988; 61 FR 40345, Aug. 2, 1996]



Sec. 406.7  Forms to apply for entitlement under Medicare Part A.

    The following forms, available free of charge by mail from HCFA or 
at any Social Security branch or district office, are used to apply for 
Medicare entitlement under the circumstances indicated:

    HCFA-18-F-5--Application for Hospital Insurance Entitlement. (For 
use by individuals who are not eligible for retirement benefits under 
Title II of the Social Security Act or under the Railroad Retirement 
Act. This form may also be used for enrollment in the supplementary 
medical insurance program.)
    HCFA-43--Application for Health Insurance Benefits under Medicare 
for Individuals with End Stage Renal Disease (ESRD). (An initial 
application for entitlement by individuals with ESRD).


As an alternative, an individual may use the application for monthly 
social benefits to apply also for Medicare entitlement if he or she is 
eligible for hospital insurance at that time.

[53 FR 6633, Mar. 2, 1988]



         Subpart B--Hospital Insurance Without Monthly Premiums



Sec. 406.10  Individual age 65 or over who is entitled to social security or railroad retirement benefits, or who is eligible for social security benefits.

    (a) Requirements. An individual is entitled to hospital insurance 
benefits under section 226 of the Act if he or she has attained aged 65 
and is:
    (1) Entitled to monthly social security benefits under section 202 
of the Social Security Act;
    (2) A qualified railroad retirement beneficiary who has been 
certified as such to the Social Security Administration by the Railroad 
Retirement Board in accordance with section 7(d) of the Railroad 
Retirement Act of 1974; or
    (3) Effective January 1, 1981, eligible for monthly social security 
benefits under section 202 of the Act and has filed an application for 
hospital insurance.
    (b) Beginning and end of entitlement. (1) Entitlement begins with 
the first day of the first month in which the individual meets the 
requirements of paragraph (a) of this section.
    (2) Entitlement continues until the individual dies or no longer 
meets the requirements of paragraph (a) of this section. An individual 
is not entitled to railroad retirement benefits and is neither entitled 
to, nor eligible for, monthly social security benefits in the month in 
which he or she dies. However, an individual who meets all other

[[Page 170]]

requirements for hospital insurance entitlement is entitled to hospital 
insurance in the month in which he or she dies if he or she--
    (i) Would have been entitled to monthly railroad retirement benefits 
or social security benefits in that month if he or she had not died; or
    (ii) Has filed an application for hospital insurance and would have 
been eligible for monthly social security benefits in that month if he 
or she had not died.



Sec. 406.11  Individual age 65 or over who is not eligible as a social security or railroad retirement benefits beneficiary, or on the basis of government 
          employment.

    (a) Basis. Section 103 of the law that established the Medicare 
program in 1965 (Pub. L. 89-97) provided for eligibility for certain 
individuals who were age 65 or would soon attain age 65 but would not be 
able to qualify for social security or railroad retirement benefits.
    (b) Requirements. Unless he or she is excluded under paragraph (c) 
of this section, an individual age 65 or over who does not meet the 
requirements of Sec. 406.10 or Sec. 406.15 (and who would not meet those 
requirements if he or she filed an application), is entitled to Medicare 
Part A benefits if he or she meets the following requirements:
    (1) Age and quarters of coverage. (i) He or she attained age 65 
before 1968; or
    (ii) If he or she attained age 65 in 1968 or later, he or she must 
have at least 3 quarters of coverage for each year that elapsed after 
1966 and before the year in which he or she attained age 65. (The 
quarters of coverage may have been acquired at any time, not necessarily 
during the elapsed years.)
    (2) Residence and citizenship. He or she is a resident of the United 
States and--
    (i) A citizen of the United States; or
    (ii) An alien lawfully admitted for permanent residence who has 
continuously resided in the United States for 5 years immediately 
preceding the first month in which he or she meets all other 
requirements for entitlement to hospital insurance.
    (3) Application. He or she has filed an application for Medicare 
Part A no earlier than the third month before the first month of 
eligibility.
    (c) Bases for exclusion. An individual who meets the requirements of 
paragraph (b) of this section is excluded from Medicare Part A if he or 
she--
    (1) Has been convicted of spying, sabotage, or treason, sedition, 
and subversive action under chapter 37, 105, or 115 of title 18 of the 
United States Code;
    (2) Has been convicted of conspiracy to establish a dictatorship 
under section 4 of the Internal Security Act of 1950;
    (3) On February 16, 1965, was or could have been covered under the 
Federal Employees Health Benefits Act (FEHBA) of 1959; or
    (4) In his or her first month of eligibility;
    (i) Is covered by an enrollment under the FEHBA; or
    (ii) Could have been covered by an enrollment under that Act if he 
or she (or any other person who could provide him or her with coverage) 
was a Federal employee at any time after February 15, 1965, and had 
enrolled and retained coverage under that Act.
    (d) End of exclusion. An individual excluded under paragraph (c)(3) 
or (4) of this section can become entitled beginning with the first 
month in which he or she loses the right to FEHBA coverage solely 
because he or she or the other person leaves Federal employment.
    (e) Beginning and end of entitlement. (1) Entitlement begins--
    (i) In the first month of eligibility if the application is filed no 
later than 12 months after the first month of eligibility:
    (ii) In the 12th month before the month of application if the 
application is filed more than 12 months after the first month of 
eligibility.
    (2) Entitlement continues until death or until the month before the 
month in which the individual becomes entitled under Sec. 406.10 or 
Sec. 406.15.

[48 FR 12536, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
53 FR 47202, Nov. 22, 1988]

[[Page 171]]



Sec. 406.12  Individual under age 65 who is entitled to social security or railroad retirement disability benefits.

    (a) Basic requirements. An individual under age 65 is entitled to 
hospital insurance benefits if, for 25 months, he or she has been--
    (1) Entitled or deemed entitled to social security disability 
benefits as an insured individual, child, widow, or widower who is 
``under a disability'' or
    (2) A disabled qualified beneficiary certified under Section 7(d) of 
the Railroad Retirement Act.
    (b) Previous periods of disability benefits entitlement. Months of a 
previous period of entitlement or deemed entitlement to disability 
benefits count toward the 25-month requirement if any of the following 
conditions is met:
    (1) Entitlement was as an insured individual or a disabled qualified 
railroad retirement beneficiary, and the previous period ended within 
the 60 months preceding the month in which the current disability began.
    (2) Entitlement was as a disabled child, widow, or widower, and the 
previous period ended within the 84 months preceding the month in which 
the current disability began.
    (3) The previous period ended on or after March 1, 1988 and the 
current impairment is the same as, or directly related to, the 
impairment on which the previous period of entitlement was based.
    (c) Deemed entitlement to disabled widow's or widower's monthly 
benefits.
    (1) Purpose. The provisions of paragraphs (c) (2), (3), and (4) of 
this section are intended to enable individuals--
    (i) To meet the 25-month requirement of paragraph (a) of this 
section; or
    (ii) To retain hospital insurance entitlement when they are no 
longer entitled to monthly disability benefits.
    (2) Deemed entitlement for certain individuals entitled to old-age 
insurance benefits. An individual who becomes entitled to monthly old-
age insurance benefits before age 65, is, by law, precluded from 
establishing or retaining entitlement to disabled widow's or widower's 
monthly benefits. However, for purposes of meeting the 25-month 
requirement, a widow or widower who meets all other requirements for 
disability benefits and is excluded solely because of entitlement to 
old-age insurance benefits, shall be deemed to be (or to continue to be) 
entitled to disability benefits. A widow or widower who is not entitled 
to disability benefits for the month before attaining age 60 must file 
two applications, one for old-age insurance benefits and one for 
hospital insurance.
    (3) Deemed entitlement for certain individuals entitled to mother's 
benefits. An individual entitled to mother's insurance benefits under 
section 202(g) of the Social Security Act cannot at the same time be 
entitled to disabled widow's benefits. However, if she applies for 
hospital insurance, she will be deemed to be entitled to disabled 
widow's monthly benefits in the first month (of the 12 months before 
application) in which she would have been entitled to those benefits if 
she had filed an application for them.
    (4) Deemed entitlement for certain individuals entitled to father's 
benefits. An individual who is entitled to father's insurance benefits 
under section 202(g) of the Act cannot at the same time be entitled to 
disabled widower's benefits. However, if he applies for hospital 
insurance benefits, he will be deemed to be entitled to disabled 
widower's monthly benefits as follows:
    (i) If he applied for hospital insurance benefits before May 1984, 
he was deemed entitled to disabled widower's benefits for any month 
after April 1981 for which he would have been entitled to those benefits 
if he had filed an application for them.
    (ii) If he applies for hospital insurance benefits in or after May 
1984, he is deemed entitled to disabled widower's benefits for any 
month, up to 12 months before the month of application, for which he 
would have been entitled to those benefits if he had filed an 
application for them.
    (iii) Hospital insurance entitlement under this paragraph (c)(4) 
could not begin before May 1983.
    (5) Deemed retroactive entitlement for certain disabled widows and 
widowers. In some cases, disabled widows or widowers cannot become 
entitled to monthly cash benefits before the month in which they file 
application. However, for purposes of meeting the

[[Page 172]]

25-month requirement, disability benefit entitlement will be deemed to 
have begun with the earliest month (of the 12 months before the 
application for cash benefits) in which the individual met all the 
requirements except the filing of an application. (This provision is 
effective for applications filed on or after January 1, 1978.)
    (d) When entitlement begins and ends. (1) Entitlement to hospital 
insurance begins with the 25th month of an individual's entitlement or 
deemed entitlement to disability benefits. Although an individual is not 
entitled to disability benefits for the month in which he or she dies, 
for purposes of this paragraph the individual will be deemed to be 
entitled for the month of death.
    (2) Except as provided in paragraph (e) of this section, entitlement 
to hospital insurance ends with the earliest of the following:
    (i) The last day of the last month in which he or she was entitled 
or deemed entitled to disability benefits or was qualified as a disabled 
railroad retirement beneficiary, if he or she was notified of the 
termination of entitlement before that month.
    (ii) The last day of the month following the month in which he or 
she is mailed a notice that his or her entitlement or deemed entitlement 
to disability benefits, or his or her status as a qualified disabled 
railroad retirement beneficiary, has ended.
    (iii) The last day of the month before the month he or she attains 
age 65. (An individual who is entitled to social security or railroad 
retirement cash benefits for the month of attainment of age 65 is 
automatically entitled to hospital insurance under Sec. 406.10.)
    (iv) The day of death.
    (e) Continuation of Medicare entitlement when disability benefit 
entitlement ends because of substantial gainful activity (SGA)--(1) 
Definitions. As used in this section--
    Trial work period means the 9-month period provided under title II 
of the Act and as defined 20 CFR 404.1592, during which the individual 
may test his or her ability to work and still receive disability cash 
benefits; and
    Reentitlement period means a period as defined in 20 CFR 404.1592a 
that begins with the first month after the trial work period and ends 
with the 36th month after the trial work period or, if earlier, with the 
first month in which the impairment no longer exists or is no longer 
disabling. (During the reentitlement period, benefits may be 
discontinued because of SGA. However, if SGA is later discontinued, 
benefits may be reinstated without a new application and a new 
disability determination.)
    (2) Duration of continued Medicare entitlement. Effective January 1, 
1988, if an individual's entitlement to disability benefits or status as 
a qualified disabled railroad retirement beneficiary ends because he or 
she engaged in, or demonstrated the ability to engage in, substantial 
gainful activity after the 36 months following the end of the trial work 
period, Medicare entitlement continues until the earlier of the 
following:
    (i) The last day of the 24th month following the first month of SGA 
occurring after the 15th month of the individual's reentitlement period 
or, if later, the end of the month following the month the individual's 
disability benefit entitlement ends.
    (ii) The last day of the month following the month in which notice 
is mailed to the individual indicating that he or she is no longer 
entitled to hospital insurance because of an event or circumstance (for 
example, there has been medical improvement, or the disabled widow has 
remarried) that would terminate disability benefit entitlement if it had 
not already been terminated because of substantial gainful activity.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47202, Nov. 22, 1988; 56 FR 38078, Aug. 12, 1991; 56 
FR 50058, Oct. 3, 1991; 61 FR 40345, Aug. 2, 1996]



Sec. 406.13  Individual who has end-stage renal disease.

    (a) Statutory basis and applicability. This section explains the 
conditions of entitlement to hospital insurance benefits on the basis of 
end-stage renal disease, and specifies the beginning and end of the 
period of entitlement. It implements section 226A of the Social Security 
Act.

[[Page 173]]

    (b) Definitions. As used in this section:
    End-stage renal disease (ESRD) means that stage of kidney impairment 
that appears irreversible and permanent and requires a regular course of 
dialysis or kidney transplantation to maintain life.
    Child or spouse means a child or spouse whose relationship to the 
parent or spouse meets the relationship requirements for entitlement to 
child's monthly social security benefits or to wife's, husband's, 
widow's, widower's, mother's or father's monthly benefits, as set forth 
in 20 CFR part 404. However, the duration of relationship requirements 
apply only to divorced spouses. (See 20 CFR 404.331.)
    Dependent child means a person who, on the first day he or she has 
end-stage renal disease, is unmarried and meets the dependency 
requirements for entitlement to child's social security benefits on the 
basis of a parent's earnings (see 20 CFR 404.350-404.365) and who--
    (1) Is under age 22;
    (2) Is under a disability that began before age 22; or
    (3) Is under age 26, is receiving at least one-half support from 
that parent, and has continuously received at least one-half support 
from that parent since the day before attaining age 22.
    One-half support means regular contributions, in cash or in kind, 
that equals or exceeds one-half of the child's total support.
    (c) Requirements. An individual is entitled to hospital insurance 
benefits if--
    (1) He or she is medically determined to have ESRD;
    (2) He or she is:
    (i) Fully or currently insured under the social security program 
(title II of the Act) or would be fully or currently insured if his or 
her employment (after 1936) as defined under the Railroad Retirement Act 
were considered ``employment'' under the Social Security Act;
    (ii) Entitled to monthly social security or railroad retirement 
benefits; or
    (iii) The spouse or dependent child of a person who meets the 
requirements of paragraph (c)(2)(i) or (c)(2)(ii) of this section;
    (3) He or she has filed an application for Medicare Part A; and
    (4) He or she has satisfied the waiting period explained in 
paragraph (e) of this section.
    (d) Filing an application. (1) An individual may obtain an 
application form, and help in completing it, from any social security 
office.
    (2) An application is not valid if it is filed earlier than the 
third month before the month in which the individual meets the 
conditions of paragraphs (c)(1), (c)(2), and (c)(4) of this section.
    (3) If an individual who has ESRD dies before he or she has filed an 
application, or is unable to file because of physical or mental 
condition, a relative or other person responsible for his or her affairs 
may file in his or her behalf. If a responsible person is not available, 
the hospital or dialysis facility that furnished treatment may file the 
application.
    (e) Beginning of entitlement--(1) Basic limitations. Entitlement can 
begin no earlier than the first month in which the individual meets the 
conditions specified in paragraph (c) of this section, or the 12th month 
before the month of application, whichever is later.
    (2) Waiting period. Entitlement begins on the first day of the third 
month after the month in which the individual initiates a regular course 
of renal dialysis, if the course is maintained throughout the waiting 
period, unless entitlement would begin earlier under paragraph (e) (3) 
or (4) of this section. This means that if dialysis began in January, 
entitlement would begin April 1.
    (3) Exceptions: Early kidney transplant. If the individual receives 
a transplant, entitlement begins with the first day of the month in 
which the transplant was performed. However, if the individual is 
admitted as an inpatient to a hospital that is an approved renal 
transplantation center or renal dialysis center (see Sec. 405.2102) for 
procedures preliminary to transplant surgery, entitlement begins--
    (i) On the first day of the month in which he or she initially 
enters the hospital, if the transplant is performed in that month or in 
either of the next 2 months; or
    (ii) On the first day of the second month before the month of kidney

[[Page 174]]

transplantation, if the transplant is delayed more than 2 months after 
the month of initial hospital stay.

For example, if an individual enters the hospital in January, and the 
transplant is performed in January, February, or March, entitlement 
would begin January 1. However, if the transplant is performed in April, 
entitlement would begin February 1.
    (4) Exceptions: Self-dialysis training. Entitlement begins on the 
first day of the month in which a regular course of renal dialysis began 
if:
    (i) Before the end of the waiting period, the individual 
participates in a self-dialysis training program offered by a 
participating Medicare facility that is approved to provide such 
training;
    (ii) The patient's physician has certified that it is reasonable to 
expect the individual will complete the training program and will self-
dialyze on a regular basis; and
    (iii) The regular course of dialysis is maintained throughout the 
time that would otherwise be the waiting period (unless it is terminated 
earlier because the individual dies).
    (f) End of entitlement. Entitlement ends with----
    (1) The end of the 12th month after the month in which a regular 
course of dialysis ends; or
    (2) The end of the 36th month after the month in which the 
individual has received a kidney transplant.
    (g) Resumption of entitlement. Entitlement is resumed under the 
following conditions:
    (1) An individual who initiates a regular course of renal dialysis 
or has a kidney transplant during the 12-month period after the previous 
course of dialysis ended is entitled to Part A benefits and eligible to 
enroll in Part B with the month the regular course of dialysis is 
resumed or the month the kidney is transplanted.
    (2) An individual who initiates a regular course of renal dialysis 
or has a kidney transplant during the 36-month period after an earlier 
kidney transplant is entitled to Part A benefits and eligible to enroll 
in Part B with the month the regular course of dialysis begins or with 
the month the subsequent kidney transplant occurs.
    (3) An individual who initiates a regular course of renal dialysis 
more than 12 months after the previous course of regular dialysis ended 
or more than 36 months after the month of a kidney transplant is 
eligible to enroll in Part A and Part B with the month in which the 
regular course of dialysis is resumed. If he or she is otherwise 
entitled under the conditions specified in paragraph (c) of this 
section, including the filing of an application, entitlement begins with 
the month in which dialysis is initiated or resumed, without a waiting 
period, subject to the limitations of paragraph (e)(1) of this section.

[48 FR 12536, Mar. 25, 1983, as amended at 60 FR 22535, May 8, 1995]



Sec. 406.15  Special provisions applicable to Medicare qualified government employment.

    (a) Definition. As used in this section, Medicare-qualified 
government employment means Federal, State, or local government 
employment that is subject only to the hospital insurance portion of the 
tax imposed by the Federal Insurance Contributions Act (F.I.C.A.). This 
includes--
    (1) Wages paid for Federal employment after December 1982.
    (2) Wages paid to State and local government employees hired after 
March 31, 1986.
    (3) Wages paid to State and local government employees hired before 
April 1, 1986 but whose employment after March 31, 1986 is covered, for 
Medicare purposes only, under an agreement under section 218 of the Act.
    (b) Crediting of wages that are taxable only for Medicare purposes. 
Medicare qualified government employment is credited in the same way and 
in the same amount as social security covered employment is credited for 
monthly social security cash benefit purposes. However, since only the 
Medicare portion (not the social security portion) of the F.I.C.A. tax 
is imposed, Medicare qualified government employment does not help 
qualify the individual for monthly Social Security cash benefits.
    (c) Required quarters of coverage. (1) To qualify for hospital 
insurance on the basis of Medicare qualified government employment, an 
individual must

[[Page 175]]

have the number of quarters of coverage necessary to qualify for 
hospital insurance under Sec. 406.10, Sec. 406.12, or Sec. 406.13.
    (2) An individual who has worked in Medicare qualified government 
employment may qualify for hospital insurance on the basis of Medicare 
qualified government employment exclusively, or a combination of 
Medicare qualified government employment and social security covered 
employment.
    (d) Transitional provision for Federal employment. Any individual 
who was a Federal employee at any time both during and before January 
1983 will receive credit for quarters of Federal employment before 
January 1983 without paying tax. This transitional provision applies 
even if the Federal employee did not receive Federal wages for January 
1983, for instance, because he or she was on approved leave without pay 
or on loan to a State or foreign agency.
    (e) Conditions of entitlement. An individual who has worked in 
Medicare qualified government employment (or any related individual who 
would be entitled to social security cash benefits on the employee's 
record if Medicare qualified government employment qualified for those 
benefits) is entitled to hospital insurance benefits if he or she--
    (1) Would meet the requirements of Sec. 406.10, Sec. 406.12, or 
Sec. 406.13 if Medicare qualified government employment were social 
security covered employment; and
    (2) Has filed an application for hospital insurance.

For purposes of this section not more than 12 months before the month of 
application may be counted towards the 25-month qualifying period 
specified in Sec. 406.12(a).
    (f) Beginning and end of entitlement--(1) Basic rule. Subject to the 
limitations specified in paragraph (f)(2) and (f)(3) of this section, 
entitlement begins and ends as specified in Sec. 406.10, Sec. 406.12 or 
Sec. 406.13, whichever is used to establish hospital insurance 
entitlement for the Federal, State, or local government employee or 
related individual.
    (2) Limitations: Federal government employment. (i) Hospital 
insurance entitlement based on Federal employment could not begin before 
January 1983.
    (ii) No months before January 1983 may be used to satisfy the 
qualifying period required for entitlement based on disability.
    (3) Limitations: State and local government employment. (i) Hospital 
insurance entitlement based on State or local government employment 
cannot begin before April 1986.
    (ii) No months before April 1986 may be used to satisfy the 
qualifying period required for entitlement based on disability.

[53 FR 47202, Nov. 22, 1988]



                  Subpart C--Premium Hospital Insurance



Sec. 406.20  Basic requirements.

    (a) General provisions. Hospital insurance benefits are available to 
most individuals age 65 or over and to certain individuals under age 65 
who do not qualify for those benefits under subpart B of this part and 
are willing to pay a monthly premium. This is called premium hospital 
insurance.
    (b) Eligibility of individuals age 65 or over to enroll for premium 
hospital insurance. Any individual is eligible to enroll for Medicare 
Part A if he or she--
    (1) Has attained age 65;
    (2) Is a resident of the United States and is either--
    (i) A citizen of the United States; or
    (ii) An alien lawfully admitted for permanent residence who has 
resided in the United States continuously for the 5-year period 
immediately preceding the month in which he or she meets all other 
requirements;
    (3) Is not eligible for Part A benefits under subpart B of this 
part; and
    (4) Is entitled to supplementary medical insurance (Part B of 
Medicare) or is eligible and has enrolled for it during an enrollment 
period.
    (c) Eligibility of individuals under age 65 to enroll for premium 
hospital insurance. An individual who has not attained age 65 is 
eligible to enroll for Medicare Part A if he or she meets the following 
conditions:
    (1) Has been entitled to Medicare Part A (under Sec. 406.12 or 
Sec. 406.15) on the

[[Page 176]]

basis of entitlement or deemed entitlement to social security disability 
benefits, as provided under section 226(b) of the Act.
    (2) Continues to have a disabling physical or mental impairment.
    (3) Loses entitlement to disability benefits (and therefore also 
loses entitlement to Medicare Part A under Sec. 406.12) solely because 
his or her earnings exceed the amount allowed under the social security 
regulations pertaining to ``substantial gainful activity'' (20 CFR 
404.1571-404.1574); and
    (4) Is not otherwise entitled to Medicare Part A.

[56 FR 38078, Aug. 12, 1991; 56 FR 50058, Oct. 3, 1991]



Sec. 406.21  Individual enrollment.

    (a) Basic provision. An individual who meets the requirements of 
Sec. 406.20 (b) or (c) may enroll for premium hospital insurance only 
during his or her ``initial enrollment period'', a ``general enrollment 
period'', a ``special enrollment period'', or, for HMO/CMP enrollees, a 
``transfer enrollment period'', as set forth in paragraphs (b) through 
(f) of this section.
    (b) Initial enrollment periods--(1) Initial enrollment period for 
individual age 65 or over. The initial enrollment period extends for 7 
months, from the third month before the month the individual first meets 
the requirements of Sec. 406.20 (b)(1) through (b)(3) through the third 
month after that first month of eligibility.
    (2) Initial enrollment period of individual under age 65. The 
initial enrollment period begins with the month in which the individual 
receives notice that entitlement to Medicare Part A will end because he 
or she has lost entitlement to disability benefits solely because of 
earnings in excess of the amounts allowed under the social security 
regulations on substantial gainful activity (20 CFR 404.1571-404.1574). 
It continues for 7 full months after that month.
    (c) General enrollment period. (1) Except as specified in paragraph 
(c)(4) of this section, the general enrollment period extends from 
January 1 to March 31 of each calendar year.
    (2) General enrollment periods are for individuals who do not enroll 
during the special enrollment period, who failed to enroll during the 
initial enrollment period, or whose previous period of entitlement had 
terminated.
    (3) If the individual enrolls or reenrolls during a general 
enrollment period, his or her entitlement begins on July 1 of the 
calendar year.
    (4) During the period April 1 through September 30, 1981, the 
general enrollment period was any time after the end of the individual's 
initial enrollment period. Any eligible individual whose initial 
enrollment period has ended, or whose previous period of entitlement had 
terminated, could enroll or reenroll during that 6-month period.
    (d) ``Deemed'' initial enrollment period for individual age 65 or 
over. (1) If an individual who has attained age 65 fails to enroll 
during the initial enrollment period because of reliance on incorrect 
documentary information which led him or her to believe that he or she 
was not yet age 65, an initial enrollment period may be established for 
him or her as though he or she had attained age 65 on the date indicated 
by the incorrect documentary information.
    (2) The deemed initial enrollment period will be used to determine 
the individual's premium and right to enroll in a general enrollment 
period if such use is advantageous to the individual.
    (e)  [Reserved]
    (f) Transfer enrollment period for HMO/CMP enrollees. (1) 
Terminology. HMO or CMP means an eligible organization as defined in 
Sec. 417.401 which has a contract with HCFA under part 417, subpart L of 
this chapter.
    (2) Basic rule. Effective February 1, 1991, individuals enrolled in 
an HMO or CMP under part 417, subpart K of this chapter who meet the 
requirements of Sec. 406.20(b) may enroll in premium hospital insurance 
during a transfer enrollment period. This transfer enrollment period 
begins with any month or any part of a month in which the individual is 
enrolled in an HMO or CMP and ends with the last day of the 8th 
consecutive month in which the individual is no longer enrolled in the 
HMO or CMP.
    (3) Effective date of coverage. (i) If the individual enrolls in 
premium hospital insurance while still enrolled in an

[[Page 177]]

HMO or CMP, or during the first month that he or she is no longer 
enrolled in the HMO or CMP, part A coverage will begin on the first day 
of the month of part A enrollment, or, at the option of the individual, 
on the first day of any of the following 3 months.
    (ii) If the individual enrolls in premium hospital insurance during 
any of the last 7 months of the transfer enrollment period, coverage 
will begin on the first day of the month after the month of enrollment.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47203, Nov. 22, 1988; 56 FR 38079, Aug. 12, 1991; 57 
FR 36014, Aug. 12, 1992; 61 FR 40345, Aug. 2, 1996]



Sec. 406.22  Effect of month of enrollment on entitlement.

    (a) Individual age 65 or over. For an individual who has attained 
age 65, the following rules apply:
    (1) If the individual enrolls during the 3 months before the first 
month of eligibility, entitlement begins with the first month of 
eligibility.
    (2) If the individual enrolls in the first month of eligibility, 
entitlement begins with the following month.
    (3) If the individual enrolls during the month after the first month 
of eligibility, entitlement begins with the second month after the month 
of enrollment.
    (4) If the individual enrolls in either of the last 2 months of the 
enrollment period, entitlement begins with the third month after the 
month of enrollment.
    (b) Individual under age 65. For an individual who has not attained 
age 65, the following rules apply:
    (1) If the individual enrolls before the month in which he or she 
meets the requirements of Sec. 406.20(c), entitlement begins with the 
month in which the individual meets those requirements.
    (2) If the individual enrolls in the month in which he or she first 
meets the requirements of Sec. 406.20(c), entitlement begins with the 
following month.
    (3) If the individual enrolls in the month following the month in 
which he or she meets the requirements of Sec. 406.20(c), entitlement 
begins with the second month after the month of enrollment.
    (4) If the individual enrolls more than one month after the month in 
which he or she first meets the requirements of Sec. 406.20(c), 
entitlement begins with the third month after the month of enrollment.

[56 FR 38079, Aug. 12, 1991]



Sec. 406.24  Special enrollment period.1
---------------------------------------------------------------------------

    \1\ Before August 1986, SEPs were available only for enrollment in 
supplementary medical insurance, not for enrollment in premium hospital 
insurance.
---------------------------------------------------------------------------

    (a) Terminology. As used in this subpart, the following terms have 
the indicated meanings.
    (1) Current employment status has the meaning given this term in 
Sec. 411.104 of this chapter.
    (2) Family member has the meaning given this term in Sec. 411.201 of 
this chapter.
    (3) Group health plan (GHP) and large group health plan (LGHP) have 
the meanings given those terms in Sec. 411.101 of this chapter, except 
that the ``former employee'' language of those definitions does not 
apply with respect to SEPs because--
    (i) Section 1837(i)(1)(A) of the Act explicitly requires that GHP 
coverage of an individual age 65 or older, be by reason of the 
individual's (or the individual's spouse's) current employment status; 
and
    (ii) The sentence following section 1837(i)(1)(B), of the Act refers 
to ``large group health plan''. Under section 1862(b)(1)(B)(i), as 
amended by OBRA '93, LGHP coverage of a disabled individual must be ``by 
virtue of the individual's or a family member's current employment 
status with an employer''.
    (4) Special enrollment period (SEP) is a period provided by statute 
to enable certain individuals to enroll in Medicare without having to 
wait for the general enrollment period.
    (b) Duration of SEP.2 (1) The SEP includes any month 
during any part of which--
---------------------------------------------------------------------------

    \2\ Before March 1995, SEPs began on the first day of the first 
month the individual was no longer covered under a GHP or LGHP by reason 
of current employment status.

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

[[Page 178]]

    (i) An individual over age 65 is enrolled in a GHP by reason of the 
current employment status of the individual or the individual's spouse; 
or
    (ii) An individual under age 65 and disabled--
    (A) Is enrolled in a GHP by reason of the current employment status 
of the individual or the individual's spouse; or
    (B) Is enrolled in an LGHP by reason of the current employment 
status of the individual or a member of the individual's family.
    (2) The SEP ends on the last day of the eighth consecutive month 
during which the individual is at no time enrolled in a GHP or an LGHP 
by reason of current employment status.
    (c) Conditions for use of a SEP.3 In order to use a SEP, 
the individual must meet the following conditions:
---------------------------------------------------------------------------

    \3\ Before August 10, 1993, an individual under age 65 could qualify 
for a SEP only if he or she had LGHP coverage as an ``active 
individual'', which the statute defined as ``an employee, employer, 
self-employed individual (such as the employer), individual associated 
with the employer in a business relationship, or as a member of the 
family of any of those persons''.
---------------------------------------------------------------------------

    (1) When first eligible to enroll for premium hospital insurance 
under Sec. 406.20(b) or (c), the individual was--
    (i) Age 65 or over and covered under a GHP by reason of the current 
employment status of the individual or the individual's spouse;
    (ii) Under age 65 and covered under an LGHP by reason of the current 
employment status of the individual or a member of the individual's 
family ; or
    (iii) Under age 65 and covered under a GHP by reason of the current 
employment status of the individual or the individual's spouse.
    (2) For all the months thereafter, the individual has maintained 
coverage either under hospital insurance or a GHP or LGHP.
    (d) Special rule: Additional SEPs. (1) Generally, if an individual 
fails to enroll during any available SEP, he or she is not entitled to 
any additional SEPs.
    (2) However, if an individual fails to enroll during a SEP, because 
coverage under the same or a different GHP or LGHP was restored before 
the end of that particular SEP, that failure to enroll does not preclude 
additional SEPs.
    (e) Effective date of coverage. (1) If the individual enrolls in a 
month during any part of which he or she is covered under a GHP or LGHP 
on the basis of current employment status, or in the first full month 
when no longer so covered, coverage begins on the first day of the month 
of enrollment or, at the individual's option, on the first day of any of 
the three following months.
    (2) If the individual enrolls in any month of the SEP other than the 
months specified in paragraph (e)(1) of this section, coverage begins on 
the first day of the month following the month of enrollment.

[61 FR 40346, Aug. 2, 1996]



Sec. 406.26  Enrollment under State buy-in.

    (a) Enrollment of QMBs under a State buy-in agreement--(1) Effective 
date. Beginning with calendar year 1990, a State may request and be 
granted a modification of its buy-in agreement to include enrollment and 
payment of Part A premiums for QMBs (as defined in section 1905(p)(1) of 
the Act) who can become entitled to Medicare Part A only by paying a 
premium.
    (2) Amount of premium. Premiums paid under State buy-in are not 
subject to increase because of late enrollment or reenrollment.
    (b) Beginning of coverage under buy-in. The coverage period begins 
with the latest of the following:
    (1) The third month following the month in which the agreement 
modification covering QMBs is effectuated.
    (2) The first month in which the individual is entitled to premium 
hospital insurance under Sec. 406.20(b) and has QMB status.
    (3) The date specified in the agreement modification.
    (c) End of coverage under buy-in. Buy-in coverage ends with the 
earlier of the following:
    (1) Death. Coverage ends on the last day of the month in which the 
QMB dies.
    (2) Loss of QMB status. If the individual loses eligibility for QMB 
status, coverage ends on the last day of the month in which HCFA 
receives the State's notice of ineligibility.

[[Page 179]]

    (3) Termination of buy-in agreement. If the State's buy-in agreement 
is terminated, coverage ends on the last day of the last month for which 
the agreement is in effect.
    (4) Entitlement to premium-free Part A. If the individual becomes 
entitled to premium-free Part A, buy-in coverage ends on the last day of 
entitlement to premium Part A.
    (d) Continuation of coverage: Individual enrollment following 
termination of buy-in coverage--(1) Deemed enrollment. If coverage under 
a buy-in agreement ends because the agreement is terminated or the 
individual loses QMB status, the individual--
    (i) Is considered to have enrolled during his or her initial 
enrollment period; and
    (ii) Is entitled to Part A benefits and liable for Part A premiums 
beginning with the first month for which he or she is no longer covered 
under the buy-in agreement.
    (2) Voluntary termination. (i) An individual may voluntarily 
terminate entitlement acquired under paragraph (d)(1) of this section by 
filing, with SSA or HCFA, a request for disenrollment.
    (ii) Voluntary disenrollment is effective as follows:
    (A) If the individual files a request within 30 days after the date 
of HCFA's notice that buy-in coverage has ended, the individual's 
entitlement ends on the last day of the last month for which the State 
paid the premium.
    (B) If the individual files the request more than 30 days but not 
more than 6 months after buy-in coverage ends, entitlement ends on the 
last day of the month in which the request is filed.
    (C) If the individual files the request later than the 6th month 
after buy-in coverage ends, entitlement ends at the end of the month 
after the month in which request is filed.

[56 FR 38080, Aug. 12, 1991]



Sec. 406.28  End of entitlement.

    Any of the following actions or events ends entitlement to premium 
hospital insurance:
    (a) Filing of request for termination. The beneficiary may at any 
time give HCFA or the Social Security Administration written notice that 
he or she no longer wishes to participate in the premium hospital 
insurance program.
    (1) If he or she files the notice before entitlement begins, he or 
she will be deemed not to have enrolled.
    (2) If he or she files the notice after entitlement begins, that 
entitlement will end at the close of the month following the month in 
which he or she filed the notice.
    (b) Eligibility for hospital insurance without premiums. (1) If an 
individual meets the eligibility requirements for hospital insurance 
specified in Sec. 406.10, Sec. 406.11, Sec. 406.13 or Sec. 406.15, 
entitlement to premium hospital insurance ends with the month before the 
month in which he or she meets those requirements.
    (2) If an individual meets the requirements of Sec. 406.10, 
Sec. 406.11, Sec. 406.13, or Sec. 406.15, he or she will be deemed to 
have filed the required application for hospital insurance benefits in 
his or her first month of eligibility under that section.
    (c) End of entitlement to supplementary medical insurance (SMI) for 
individual who has attained age 65. In the case of an individual 
enrolled on the basis of Sec. 406.20(b), entitlement to premium hospital 
insurance ends on the same date that entitlement to SMI ends.
    (d) Nonpayment of premium. (1) If an individual fails to pay the 
premium bill, entitlement will end on the last day of the third month 
after the billing month.
    (2) HCFA may reinstate entitlement if the individual shows good 
cause for failure to pay on time, and pays all overdue premiums within 3 
calendar months after the date specified in paragraph (d)(1) of this 
section.
    (e) Death. Entitlement ends with the day of death. (A premium is due 
for the month of death.)
    (f) End of disabling impairment for individual under age 65. In the 
case of an individual enrolled on the basis of Sec. 406.20(c), 
entitlement to premium hospital insurance ends on the last day of the 
month after the month in which the individual is notified that he or she 
no longer has a disabling impairment.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47204, Nov. 22, 1988. Redesignated and amended at 56 
FR 38080, Aug. 12, 1991]

[[Page 180]]



Sec. 406.32  Monthly premiums.

    (a) Promulgation and effective date. Beginning with 1984, premiums 
are promulgated each September, effective for the succeeding calendar 
year.
    (b) Monthly premiums: Determination of dollar amount.
    (1) Effective for calendar years beginning January 1989, the dollar 
amount is determined based on an estimate of one-twelfth of the average 
per capita costs for benefits and administrative costs that will be 
payable with respect to individuals age 65 or over from the Federal 
Hospital Insurance Trust Fund during the succeeding calendar year.
    (2) Before 1989, the dollar amount was determined by multiplying $33 
by the ratio of the next year's inpatient deductible to $76, which was 
the inpatient deductible determined for 1973. (Because of cost controls, 
the deductible actually charged for that year was $72.)
    (3) Effective for months beginning January 1994, if an individual 
meets the requirements in paragraph (c) of this section, the monthly 
premium determined under paragraph (b)(1) of this section is reduced in 
each month in which the individual meets the requirements by 25 percent 
in 1994, 30 percent in 1995, 35 percent in 1996, 40 percent in 1997 and 
45 percent in 1998 and thereafter.
    (4) The amount determined under paragraphs (b) (1), (2), or (3) of 
this section is rounded to the next nearest multiple of $1. (Fifty cents 
is rounded to the next higher dollar.)
    (c) Qualifying for a reduction in monthly premium. An individual who 
qualifies for the reduction described in paragraph (b)(3) of this 
section must be an individual who--
    (1) Has 30 or more quarters of coverage (QCs) as defined in 20 CFR 
404.140 through 404.146;
    (2) Has been married for at least the previous one year period to a 
worker who has 30 or more QCs;
    (3) Had been married to a worker who had 30 or more QCs for a period 
of at least one year before the death of the worker;
    (4) Is divorced from, after at least 10 years of marriage to, a 
worker who had 30 or more QCs at the time the divorce became final; or
    (5) Is divorced from, after at least 10 years of marriage to, a 
worker who subsequently died and who had 30 or more QCs at the time the 
divorce became final.
    (d) Monthly premiums: Increase for late enrollment and for 
reenrollment. For an individual who enrolls after the close of the 
initial enrollment period or reenrolls, the amount of the monthly 
premium, as determined under paragraph (b) of this section, is increased 
by 10 percent for each full 12 months in the periods described in 
Secs. 406.33 and 406.34. Effective beginning with premiums due for July 
1986, the premium increase is limited to 10 percent and is payable for 
twice the number of full 12-month periods determined under those 
sections.
    (e) Collection of monthly premiums. (1) HCFA will bill the enrollee 
on a monthly basis and include an addressed return envelope with the 
bill.
    (2) The enrollee must pay by check or money order that is payable to 
``HCFA Medicare Insurance,'' and shows his or her name and the claim 
number that appears on his or her Medicare card. He or she must return 
the bill with the check or money order.
    (f) Months for which payment is due. (1) A premium payment is due 
for each month beginning with the first month of coverage and continuing 
through the month of death or if earlier, the month in which coverage 
ends.
    (2) A premium is due for the month of death if coverage is still in 
effect, even if the individual dies on the first day of the month.
    (g) Option for group payments. A public or private organization may 
pay the premiums on behalf of one or more enrollees under a contract or 
other arrangement with HCFA if HCFA determines that this method of 
payment is administratively feasible. (The rules set forth in subpart E 
of part 408 of this chapter, for SMI premiums, also apply to group 
payment of Part A premiums.)

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47203, Nov. 22, 1988; 56 FR 8839, Mar. 1, 1991. 
Redesignated and amended at 56 FR 38079, 38080, Aug. 12, 1991; 57 FR 
36014, Aug. 12, 1992; 57 FR 58717, Dec. 11, 1992; 59 FR 26959, May 25, 
1994]

[[Page 181]]



Sec. 406.33  Determination of months to be counted for premium increase: Enrollment.

    (a) Enrollment before April 1, 1981, or after September 30, 1981. 
The months to be counted for premium increase are the months from the 
end of the initial enrollment period through the end of the general 
enrollment period, the special enrollment period, or the transfer 
enrollment period in which the individual enrolls, excluding the 
following:
    (1) Any months before September 1973.
    (2) For premiums due for months after May 1986, any months beginning 
with January 1983 during which the individual was enrolled in an 
employer group health plan based on the current employment of the 
individual or the individual's spouse.
    (3) Any months during the 7-month special enrollment period under 
Sec. 406.21(e) during which premium hospital insurance coverage is in 
effect.
    (4) Any months that the individual was enrolled in an HMO or CMP 
under part 417, subpart K of this chapter as described in 
Sec. 406.21(f).
    (b) Enrollment during the period April 1 through September 30, 1981. 
The months to be counted for premium increase are the months from the 
end of the initial enrollment period through the month in which the 
individual enrolled, excluding any months before September 1973.
    (c) Examples. (1) John F's initial enrollment period ended July 1979 
but he did not enroll until January 1980. The months to be counted are 
August 1979 through March 1980. Since only 8 months elapsed, there is no 
premium increase.
    (2) Mary T's initial enrollment period ended in April 1980 but she 
did not enroll until May 1981. The months to be counted are May 1980 
through May 1981. Since 13 months has elapsed, the premium would be 
increased by 10 percent.
    (3) Effective with July 1986, Mary T, in Example 2, would no longer 
have to pay an increased premium because she had paid it for twice the 
number of full 12-month periods during which she could have been, but 
was not, enrolled in the program.
    (4) Vincent C's initial enrollment period ended August 31, 1986. He 
was covered under his wife's employer group health plan until she 
retired on May 31, 1989. He enrolled during June 1989, the first month 
of the special enrollment period under Sec. 406.21(e). No months are 
countable for premium increase purposes because the exclusions of 
paragraph (a) of this section apply to all months.
    (5) Terry P enrolled in the 1987 general enrollment period, with 
coverage effective July 1987. There were 28 months after the end of his 
initial enrollment period through the end of the 1987 general enrollment 
period. His premium is increased by 10 percent. The increase will be 
eliminated after he has paid the additional 10 percent for 48 months.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986, 
as amended at 53 FR 47203, Nov. 22, 1988. Further redesignated and 
amended at 57 FR 36014, Aug. 12, 1992]



Sec. 406.34  Determination of months to be counted for premium increase: Reenrollment.

    (a) First reenrollment before April 1, 1981 or after September 30, 
1981. The months to be counted for premium increase are:
    (1) The months specified in Sec. 406.33(a) or (b); plus
    (2) The months from the end of the first period of entitlement 
through the end of the general enrollment period in which the individual 
reenrolled.
    (b) First reenrollment during the period April 1, 1981 through 
September 30, 1981. The months to be counted for premium increase are--
    (1) The months specified in Sec. 406.33(a); plus
    (2) The months from the end of the first period of entitlement 
through the month in which the individual reenrolled.
    (c) Subsequent reenrollment during the period April 1, 1981 through 
September 30, 1981. The months to be counted for premium increase are--
    (1) The months specified in paragraph (a) of this section; plus
    (2) The months from April 1981 through the month in which the 
individual reenrolled for the second time. (Since only one reenrollment 
was permitted before April 1981, any months from the end of the 
individual's first

[[Page 182]]

enrollment period of entitlement through March 1981 are not counted.)
    (d) Subsequent reenrollment after September 30, 1981. The months to 
be counted for premium increase are--
    (1) The months specified in paragraph (a) or (b) of this section, 
for the first and second periods of coverage; plus
    (2) The months from the end of each subsequent period of entitlement 
through the end of the general enrollment period in which the individual 
reenrolled, excluding any months before April 1981.
    (e) Example. Peter M enrolled during his initial enrollment period, 
terminated his first coverage period in August 1979 and reenrolled for 
the first time in January 1980. The 7 months to be counted (September 
1979 through March, 1980) were not enough to require any increase in the 
premium. Peter terminated his second period of coverage in February 1981 
and reenrolled for the second time in July 1981. Since the 4 months 
(April through July 1981), when added to the previous 7 months, bring 
the total to only 11 months, no premium increase is required.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated and amended at 57 FR 58717, Dec. 11, 1992]



Sec. 406.38  Prejudice to enrollment rights because of Federal Government error.

    (a) If an individual's enrollment or nonenrollment for premium 
hospital insurance is unintentional, inadvertent, or erroneous because 
of the error, misrepresentation, or inaction of a Federal employee, or 
any person authorized by the Federal Government to act on its behalf, 
the Social Security Administration or HCFA may take whatever action it 
determines is necessary to provide appropriate relief.
    (b) The action may include--
    (1) Designation of a special initial or general enrollment period;
    (2) Designation of an entitlement period;
    (3) Adjustment of premiums;
    (4) Any combination of the actions specified in paragraph (b) (1) 
through (3) of this section; or
    (5) Any other remedial action which may be necessary to correct or 
eliminate the effects of such error, misrepresentation, or inaction.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated at 56 FR 38080, Aug. 12, 1991]



  Subpart D--Special Circumstances That Affect Entitlement to Hospital 
                                Insurance



Sec. 406.50  Nonpayment of benefits on behalf of certain aliens.

    (a) Hospital insurance benefit payments may not be made for services 
furnished to an alien in any month in which his or her monthly social 
security benefits are suspended (or would be suspended if he or she were 
entitled to those benefits) because the alien remains outside the United 
States for more than 6 months.
    (b) Benefits will be payable beginning with services furnished in 
the first full calendar month the alien is back in the United States.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated at 57 FR 58717, Dec. 11, 1992]



Sec. 406.52  Conviction of certain offenses.

    (a) Penalty that affects entitlement. (1) If an individual is 
convicted of any of the crimes listed in Sec. 406.11(c) (1) and (2), the 
court may impose, in addition to all other penalties, a penalty that 
affects entitlement to hospital insurance, beginning with the month of 
conviction.
    (2) The additional penalty is that the individual's income (or the 
income of the insured individual on whose earnings record he or she 
became or seeks to become entitled) for the year of conviction and any 
previous year may not be counted in determining the insured status 
necessary for entitlement to hospital insurance.
    (b) Effect of pardon. If the President of the United States pardons 
the convicted individual, that individual regains (or may again seek) 
entitlement effective with the month following the month in which the 
pardon is granted.

[48 FR 12536, Mar. 25, 1983. Redesignated at 51 FR 41338, Nov. 14, 1986. 
Further redesignated at 57 FR 58717, Dec. 11, 1992]

[[Page 183]]



PART 407--SUPPLEMENTARY MEDICAL INSURANCE (SMI) ENROLLMENT AND ENTITLEMENT--Table of Contents




                      Subpart A--General Provisions

Sec.
407.1  Basis and scope.
407.2  General description of program.
407.4  Basic requirements for entitlement.

        Subpart B--Individual Enrollment and Entitlement for SMI

407.10  Eligibility to enroll.
407.11  Forms used to apply for enrollment under Medicare Part B.
407.12  General enrollment provisions.
407.14  Initial enrollment period.
407.15  General enrollment period.
407.17  Automatic enrollment.
407.18  Determining month of automatic enrollment.
407.20  Special enrollment period related to coverage under group health 
          plans.
407.22  Request for individual enrollment.
407.25  Beginning of entitlement: Individual enrollment.
407.27  Termination of entitlement: Individual enrollment.
407.30  Limitations on enrollment.
407.32  Prejudice to enrollment rights because of Federal Government 
          misrepresentation, inaction, or error.

                   Subpart C--State Buy-in Agreements

407.40  Enrollment under a State buy-in agreement.
407.42  Buy-in groups available to the 50 States, the District of 
          Columbia, and the Northern Mariana Islands.
407.43  Buy-in groups available to Puerto Rico, Guam, the Virgin 
          Islands, and American Samoa.
407.45  Termination of State buy-in agreements.
407.47  Beginning of coverage under a State buy-in agreement.
407.48  Termination of coverage under a State buy-in agreement.
407.50  Continuation of coverage: Individual enrollment following end of 
          coverage under a State buy-in agreement.

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

    Source: 53 FR 47204, Nov. 22, 1988, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 407.1  Basis and scope.

    (a) Statutory basis. The supplementary medical insurance (SMI) 
program is authorized by Part B of title XVIII of the Social Security 
Act.
    (1) Section 1831 of the Act establishes the program.
    (2) Sections 1836 and 1837 set forth the eligibility and enrollment 
requirements.
    (3) Section 1838 specifies the entitlement periods, which vary 
depending on the time and method of enrollment and on the basis for 
termination.
    (4) Section 1843 sets forth the requirements for State buy-in 
agreements under which States may enroll, and pay the SMI premiums for, 
eligible individuals who are also eligible for cash assistance or 
Medicaid.
    (5) Section 104(b) of the Social Security Amendments of 1965 (Pub. 
L. 89-87) specifies the limitations that apply to certain aliens and 
persons convicted of subversive activities.
    (b) Scope. This part sets forth the eligibility, enrollment, and 
entitlement requirements and procedures for supplementary medical 
insurance. (The rules about premiums are in part 408 of this chapter.)



Sec. 407.2  General description of program.

    Part B of Title XVIII of the Act provides for voluntary 
``supplementary medical insurance'' available to most individuals age 65 
or over and to disabled individuals who are under age 65 and entitled to 
hospital insurance. The SMI program is financed by premiums paid by (or 
for) each individual enrolled in the program, plus contributions from 
Federal funds. It covers certain physicians' services, outpatient 
services, home health services, services furnished by rural health 
clinics (RHCs), Federally qualified health centers (FQHCS), ambulatory 
surgical centers (ASCs), and comprehensive outpatient rehabilitation 
facilities (CORFs), and other medical and other health services.

[57 FR 24980, June 12, 1992]



Sec. 407.4  Basic requirements for entitlement.

    (a) An individual must meet the following requirements to be 
entitled to SMI:

[[Page 184]]

    (1) Eligibility. The individual must meet the eligibility 
requirements specified in Sec. 407.10(a).
    (2) Enrollment. The individual must enroll for SMI, or must be 
enrolled by a State under a buy-in agreement as specified in 
Sec. 407.40.
    (b) SMI pays only for covered expenses incurred during an 
individual's period of entitlement.



        Subpart B--Individual Enrollment and Entitlement for SMI



Sec. 407.10  Eligibility to enroll.

    (a) Basic rule. Except as specified in paragraph (b) of this 
section, an individual is eligible to enroll for SMI if he or she--
    (1) Is entitled to hospital insurance under any of the rules set 
forth in Secs. 406.10 through 406.15 of this chapter; or
    (2) Meets the following requirements:
    (i) Has attained age 65. (An individual is considered to have 
attained age 65 on the day before the 65th anniversary of his or her 
birth.)
    (ii) Is a resident of the United States.
    (iii) Is a citizen of the United States, or an alien lawfully 
admitted for permanent residence who has resided continuously in the 
United States during the 5 years preceding the month in which he or she 
applies for enrollment.
    (b) Exception. An individual is not eligible to enroll for SMI if he 
or she has been convicted of--
    (1) Spying, sabotage, treason, or subversive activities under 
chapter 37, 105, or 115 of title 18 of the United States Code; or
    (2) Conspiracy to establish dictatorship under section 4 of the 
Internal Security Act of 1950.



Sec. 407.11  Forms used to apply for enrollment under Medicare Part B.

    The following forms, available free of charge by mail from HCFA, or 
at any Social Security branch or district office, are used to apply for 
enrollment under the supplementary medical insurance program.

    HCFA-4040--Application for Enrollment in the Supplementary Medical 
Insurance Program. (This form is used for enrollment by individuals who 
are not eligible for monthly benefits or for hospital insurance.)
    HCFA-40-B--Application for Medical Insurance. (For general use by 
the SSA District Office in requesting medical insurance protection 
during the general enrollment period or during the initial enrollment 
period if the enrollee is not subject to automatic enrollment is SMI.)
    HCFA-40-D--Application for Enrollment in the Supplementary Medical 
Insurance Program. (This form is mailed to individuals who do not have 
current supplementary medical insurance because of prior refusals, 
voluntary withdrawal, or premium default from prior coverage. It is used 
during the annual general enrollment period.)
    HCFA-40-F--Application for Medical Insurance. (For use by 
beneficiaries residing outside the United States.)
    HCFA-18-F-5--Application for Hospital Insurance Entitlement. (For 
use by individuals who are not eligible for retirement benefits under 
Title II of the Social Security Act or under the Railroad Retirement 
Act. This form may also be used for enrollment in the supplementary 
medical insurance program.)


As an alternative, the individual may request enrollment by answering 
the Part B enrollment questions on an application for monthly Social 
Security benefits, or by signing a simple statement of request, if he or 
she is eligible to enroll at that time.



Sec. 407.12  General enrollment provisions.

    (a) Opportunity to enroll. (1) An individual who is eligible to 
enroll for SMI may do so during an initial enrollment period or a 
general enrollment period as specified in Secs. 407.14, and 407.15. An 
individual who meets the conditions specified in Sec. 407.20 may enroll 
during a special enrollment period, as provided in that section.
    (2) An individual who fails to enroll during his or her initial 
enrollment period or whose enrollment has been terminated may enroll or 
reenroll during a general enrollment period, or, if he or she meets the 
specified conditions, during a special enrollment period.
    (b) Enrollment periods ending on a nonworkday. (1) If an enrollment 
period ends on a Federal nonworkday, that period is automatically 
extended to the next succeeding workday.
    (2) A Federal nonworkday is any Saturday, Sunday, or Federal legal 
holiday or a day that is declared by statute or executive order to be a 
day on which

[[Page 185]]

Federal employees are not required to work.



Sec. 407.14  Initial enrollment period.

    (a) Duration. (1) The initial enrollment period is the 7-month 
period that begins 3 months before the month an individual first meets 
the eligibility requirements of Sec. 407.10 and ends 3 months after that 
first month of eligibility.
    (2) In determining the initial enrollment period of an individual 
who is age 65 or over and eligible for enrollment solely because of 
entitlement to hospital insurance, the individual is considered as first 
meeting the eligibility requirements for SMI n the first day he or she 
becomes entitled to hospital insurance or would have been entitled if he 
or she filed an application for that program.
    (b) Deemed initial enrollment period. (1) SSA or HCFA will establish 
a deemed initial enrollment period for an individual who fails to enroll 
during the initial enrollment period because of a belief, based on 
erroneous documentary evidence, that he or she had not yet attained age 
65. The period will be established as though the individual had attained 
age 65 on the date indicated by the incorrect information.
    (2) A deemed initial enrollment period established under paragraph 
(b)(1) of this section is used to determine the individual's premium and 
right to enroll in a general enrollment period if that is advantageous 
to the individual.



Sec. 407.15  General enrollment period.

    (a) Except as specified in paragraph (b) of this section, the 
general enrollment period is January through March of each calendar 
year.
    (b) An unlimited general enrollment period existed between April 1 
and September 30, 1981. Any eligible individual whose initial enrollment 
period had ended, or whose previous period of entitlement had 
terminated, could have enrolled or reenrolled during any month of that 
6-month period.



Sec. 407.17  Automatic enrollment.

    (a) Who is automatically enrolled. An individual is automatically 
enrolled for SMI if he or she:
    (1) Resides in the United States, except in Puerto Rico;
    (2) Becomes entitled to hospital insurance under any of the 
provisions set forth in Secs. 406.10 through 406.15 of this chapter; and
    (3) Does not decline SMI enrollment.
    (b) Opportunity to decline automatic enrollment. (1) SSA will notify 
an individual that he or she is automatically enrolled under paragraph 
(a) of this section and grant the individual a specified period (at 
least 2 months after the month the notice is mailed) to decline 
enrollment.
    (2) The individual may decline enrollment by submitting to SSA or 
HCFA a signed statement that he or she does not wish SMI.
    (3) The statement must be submitted before entitlement begins, or if 
later, within the time limits set in the notice of enrollment.



Sec. 407.18  Determining month of automatic enrollment.

    (a) An individual who is automatically enrolled in SMI under 
Sec. 407.17 will have the month of enrollment determined in accordance 
with paragraphs (b) through (f) of this section. The month of enrollment 
determines the month of entitlement.
    (b) An individual is automatically enrolled in the third month of 
the initial enrollment period if he or she--
    (1) Is entitled to social security benefits under section 202 of the 
Act on the first day of the initial enrollment period;
    (2) Is entitled to hospital insurance based on end-stage renal 
disease; on entitlement to disability benefits as a social security or 
railroad retirement beneficiary; or on deemed entitlement to disability 
benefits on the basis of Medicare-qualified government employment; or
    (3) Establishes entitlement to hospital insurance by filing an 
application and meeting all other requirements (as set forth in subpart 
B of part 406 of this chapter) during the first 3 months of the initial 
enrollment period.
    (c) If an individual establishes entitlement to hospital insurance 
on the basis of an application filed in the last 4 months of the SMI 
initial enrollment

[[Page 186]]

period, he or she is automatically enrolled for SMI in the month in 
which the application is filed.
    (d) If an individual establishes entitlement to hospital insurance 
on the basis of an application filed after the SMI initial enrollment 
period but not during a general enrollment period in effect before April 
1, 1981, or after September 30, 1981, he or she is automatically 
enrolled for SMI on the first day of the next general enrollment period.
    (e) If the individual establishes entitlement to hospital insurance 
on the basis of an application filed during a SMI general enrollment 
period in effect before April 1, 1981 or after September 30, 1981, he or 
she is automatically enrolled on the first day of that period.
    (f) If an individual established entitlement to hospital insurance 
on the basis of an application filed during the general enrollment 
period of April 1, 1981, through September 30, 1981, he or she was 
automatically enrolled for SMI on the first day of the month in which 
the application was filed.



Sec. 407.20  Special enrollment period related to coverage under group health plans.

    (a) Terminology--(1) Group health plan (GHP) and large group health 
plan (LGHP). These terms have the meanings given them in Sec. 411.101 of 
this chapter except that the ``former employee'' language of those 
definitions does not apply with respect to SEPs for the reasons 
specified in Sec. 406.24(a)(3) of this chapter.
    (2) Special enrollment period (SEP). This term has the meaning set 
forth in Sec. 406.24(a)(4) of this chapter. In order to use a SEP, an 
individual must meet the conditions of paragraph (b) and of paragraph 
(c) or (d) of this section, as appropriate.
    (b) General rule. All individuals must meet the following 
conditions:
    (1) They are eligible to enroll for SMI on the basis of age or 
disability, but not on the basis of end-stage renal disease.
    (2) When first eligible for SMI coverage (4th month of their initial 
enrollment period), they were covered under a GHP or LGHP on the basis 
of current employment status or, if not so covered, they enrolled in SMI 
during their initial enrollment period; and
    (3) For all months thereafter, they maintained coverage under either 
SMI or a GHP or LGHP. (Generally, if an individual fails to enroll in 
SMI during any available SEP, he or she is not entitled to any 
additional SEPs. However, if an individual fails to enroll during a SEP 
because coverage under the same or a different GHP or LGHP was restored 
before the end of that particular SEP, that failure to enroll does not 
preclude additional SEPs.)
    (c) Special rule: Individual age 65 or over. For an individual who 
is or was covered under a GHP, coverage must be by reason of the current 
employment status of the individual or the individual's spouse.
    (d) Special rules: Disabled individual.4 Individuals 
entitled on the basis of disability (but not on the basis of end-stage 
renal disease) must meet conditions that vary depending on whether they 
were covered under a GHP or an LGHP.
---------------------------------------------------------------------------

    \4\ Under the current statute, the SEP provision applicable to 
disabled individuals covered under an LGHP expires on September 1998. 
Unless Congress changes that date, the last SEP available under those 
provisions will begin with June 1998.
---------------------------------------------------------------------------

    (1) For a disabled individual who is or was covered under a GHP, 
coverage must be on the basis of the current employment status of the 
individual or the individual's spouse.
    (2) For a disabled individual who is or was covered under an LGHP, 
coverage must be as follows:
    (i) Before August 10, 1993, as an ``active individual'', that is, as 
an employee, employer, self-employed individual (such as the employer), 
individual associated with the employer in a business relationship, or 
as a member of the family of any of those persons.
    (ii) On or after August 10, 1993, by reason of current employment 
status of the individual or a member of the individual's family.
    (e) Effective date of coverage. The rule set forth in Sec. 406.24(d) 
for Medicare Part A applies equally to Medicare Part B.

[61 FR 40346, Aug. 2, 1996]

[[Page 187]]



Sec. 407.22  Request for individual enrollment.

    (a) A request for enrollment is required of an individual who meets 
the eligibility requirements of Sec. 407.10 and desires SMI, if the 
individual--
    (1) Is not entitled to hospital insurance;
    (2) Has previously declined enrollment in SMI;
    (3) Has had a previous period of SMI entitlement which terminated;
    (4) Resides in Puerto Rico or outside the United States; or
    (5) Is enrolling or reenrolling during a special enrollment period 
under Sec. 407.20.
    (b) A request for enrollment under paragraph (a) of this section 
must:
    (1) Be signed by the individual or someone acting in his or her 
behalf; and
    (2) Be filed with SSA or HCFA during the initial enrollment period, 
a general enrollment period, or a special enrollment period as provided 
in Sec. 407.20.



Sec. 407.25  Beginning of entitlement: Individual enrollment.

    The following apply whether an individual is self-enrolled or 
automatically enrolled in SMI:
    (a) Enrollment during initial enrollment period. (1) If an 
individual enrolls during the first three months of the initial 
enrollment period, entitlement begins with the first month of 
eligibility.
    (2) If an individual enrolls during the fourth month of the initial 
enrollment period, entitlement begins with the following month.
    (3) If an individual enrolls during the fifth month of the initial 
enrollment period, entitlement begins with the second month after the 
month of enrollment.
    (4) If an individual enrolls in either of the last two months of the 
initial enrollment period, entitlement begins with the third month after 
the month of enrollment.
    (5) Example. An individual first meets the eligibility requirements 
for enrollment in April. The initial enrollment period is January 
through July. The month in which the individual enrolls determines the 
month that begins the period of entitlement, as follows:

------------------------------------------------------------------------
 Enrolls in initial enrollment period        Entitlement begins on--
------------------------------------------------------------------------
January...............................  April 1 (month eligibility
                                         requirements first met).
February..............................  April 1.
March.................................  April 1.
April.................................  May 1 (month following month of
                                         enrollment).
May...................................  July 1 (second month after month
                                         of enrollment).
June..................................  September 1 (third month after
                                         month of enrollment).
July..................................  October 1 (third month after
                                         month of enrollment).
------------------------------------------------------------------------

    (b) Enrollment on reenrollment during general enrollment period. (1) 
if an individual enrolls or reenrolls during a general enrollment period 
before April 1, 1981 or after September 30, 1981, entitlement begins on 
July 1 of that calendar year.
    (2) If an individual enrolled or reenrolled during the general 
enrollment period between April 1, 1981 and September 20, 1981, 
entitlement began with the third month after the month in which the 
enrollment request was filed.
    (c) Enrollment or reenrollment during a SEP. The rules set forth in 
Sec. 406.24(d) of this chapter apply.

[53 FR 47204, Nov. 22, 1988, as amended at 61 FR 40347, Aug. 2, 1996]



Sec. 407.27  Termination of entitlement: Individual enrollment.

    An individual's entitlement will terminate for any of the following 
reasons:
    (a) Death. Entitlement to SMI ends on the last day of the month in 
which the individual dies.
    (b) Termination of hospital insurance benefits. If an individual's 
entitlement to hospital insurance ends before the month in which he or 
she attains age 65, entitlement to SMI will end on the same day unless 
it has been previously terminated in accordance with paragraph (c) or 
(d) of this section.
    (c) Request by individual. An individual may at any time give HCFA 
or SSA written notice that he or she no longer wishes to participate in 
SMI, and request disenrollment.
    (1) Before July 1987, entitlement ended at the end of the calendar 
quarter after the quarter in which the individual filed the 
disenrollment request.
    (2) For disenrollment requests filed in or after July 1987, 
entitlement ends

[[Page 188]]

at the end of the month after the month in which the individual files 
the disenrollment request.
    (d) Nonpayment of premiums. If an individual fails to pay the 
premiums, entitlement will end as provided in the rules for SMI 
premiums, set forth in part 408 of this chapter.



Sec. 407.30  Limitations on enrollment.

    (a) Initial enrollment periods--(1) Individual under age 65. An 
individual who has not attained age 65 may have one or more periods of 
entitlement to hospital insurance, based on disability. Since each 
period of disability entitlement entitles the individual to hospital 
insurance and since entitlement to hospital insurance makes the 
individual eligible for SMI enrollment, an individual may have an SMI 
initial enrollment period for each continous period of entitlement to 
hospital insurance.
    (2) Individuals who have attained age 65. An individual who has 
attained age 65 may not have more than one initial enrollment period on 
the basis of age. However, if the individual develops ESRD after age 65, 
he or she may have another initial enrollment period based on meeting 
the requirements of Sec. 406.13 of this chapter.
    (b) Number of enrollments. There is no limitation on the number of 
enrollments.
    (c) Coverage under buy-in agreements. For purposes of paragraph (a) 
of this section, the continued enrollment of an individual following the 
end of coverage under a State buy-in agreement in considered an initial 
enrollment.



Sec. 407.32  Prejudice to enrollment rights because of Federal Government misrepresentation, inaction, or error.

    If an individual's enrollment or nonenrollment in SMI is 
unintentional, inadvertent, or erroneous because of the error, 
misrepresentation, on inaction of a Federal employee or any person 
authorized by the Federal Government to act in its behalf, the Social 
Security Administration or HCFA may take whatever action it determines 
is necessary to provide appropriate relief. The action may include:
    (a) Designation of a special initial or general enrollment period;
    (b) Designation of an entitlement period based on that enrollment 
period;
    (c) Adjustment of premiums;
    (d) Any combination of actions under paragraphs (a) through (c) of 
this section; or
    (e) Any other remedial action that may be necessary to correct or 
eliminate the effects of the error, misrepresentation, or inaction.



                   Subpart C--State Buy-In Agreements



Sec. 407.40  Enrollment under a State buy-in agreement.

    (a) Statutory basis. (1) Section 1843 of the Act, as amended through 
1969, permitted a State to enter into an agreement with the Secretary to 
enroll in the SMI program certain individuals who are eligible for SMI 
and who are members of the buy-in group specified in the agreement. A 
buy-in group could include certain individuals receiving Federally-aided 
State cash assistance (with the option of excluding individuals also 
entitled to social security benefits or railroad retirement benefits) or 
could include all individuals eligible for Medicaid. Before 1981, 
December 31, 1969 was the last day on which a State could request a buy-
in agreement or a modification to include a coverage group broader than 
the one originally selected.
    (2) Section 945(e) of the Omnibus Reconciliation Act of 1980 (Pub. 
L. 96-499) further amended section 1843 to provide that, during calendar 
year 1981, a State could request a buy-in agreement if it did not 
already have one, or request a broader coverage group for an existing 
agreement.
    (3) Several laws enacted during 1980-1987 had the effect of 
requiring that the buy-in groups available under section 1843 of the Act 
be expanded to include certain individuals who lose eligibility for cash 
assistance payments but are treated as if they were cash assistance 
recipients for Medicaid eligibility purposes.
    (4) Section 301(e)(1) of the Medicare Catastrophic Coverage Act of 
1988 (Pub. L. 100-360) amends section 1843 of the Act to restore the 
1981 provisions on a permanent basis, effective ``after 1988.''

[[Page 189]]

    (5) The same section 301, as amended by section 608(d)(14)(H) of the 
Family Support Act of 1988 (Pub. L. 100-485), further amended section 
1843 of the Act, beginning January 1, 1989, to establish a new buy-in 
category consisting of Qualified Medicare Beneficiaries and to provide 
that a State may request a buy-in agreement if it does not already have 
one, or request a broader buy-in group for the existing agreement.
    (b) Definitions. As used in this section, unless the context 
indicates otherwise--
    Cash assistance means any of the following kinds of monthly cash 
benefits, authorized by specified titles of the Act and, for 
convenience, represented by initials, as follows:
    AABD stands for aid to the aged, blind or disabled under the first 
title XVI of the Act in effect until December 31, 1973.
    AB stands for aid to the blind under title X of the Act.
    AFDC stands for aid to families with dependent children under Part A 
of title IV of the Act.
    APTD stands for aid to the permanently and totally disabled under 
title XIV of the Act.
    OAA stands for old-age assistance under title I of the Act.
    SSI stands for supplemental security income for the aged, blind, and 
disabled under the second title XVI of the Act, effective January 1, 
1974.
    SSP stands for State supplementary payments, whether mandatory or 
optional, to an aged, blind, or disabled individual under the second 
title XVI or the Act.
    Qualified Medicare Beneficiary or QMB means an individual who meets 
the definition in Sec. 400.200 of this chapter and, therefore, is 
eligible to have the State Medicaid agency pay Medicare cost sharing 
amounts on his or her behalf.
    Railroad retirement beneficiary means an individual entitled to 
receive an annuity under the Railroad Retirement Act of 1974.
    State means one of the 50 States, the District of Columbia, Guam, 
Puerto Rico, the Virgin Islands, American Samoa, or the Northern Mariana 
Islands, except when reference is made to ``the 50 States''.
    State buy-in agreement or buy-in agreement means an agreement 
authorized by section 1843 of the Act, under which a State secures SMI 
or premium HI coverage for individuals who are members of the buy-in 
group specified in the agreement, by enrolling them and paying the 
premiums on their behalf.
    (c) Basic rules.
    (1) A State that has a buy-in agreement in effect must enroll any 
individual who is eligible to enroll in SMI under Sec. 407.10.
    (2) Any State that does not have a buy-in agreement in effect may 
request buy-in for any one of the groups specified in Secs. 407.42 and 
407.43.
    (3) Any State that does have an agreement may request a modification 
to cover a broader buy-in group or cancel its current agreement and 
request a new agreement to cover a narrower group.

[56 FR 38080, Aug. 12, 1991; 56 FR 50058, Oct. 3, 1991]



Sec. 407.42  Buy-in groups available to the 50 States, the District of Columbia, and the Northern Mariana Islands.

    (a) Categories included in the buy-in groups. The buy-in groups that 
are available to the 50 States, the District of Columbia, and the 
Northern Mariana Islands are specified in paragraph (b) of this section 
in terms of the following categories:
    (1) Category A: Individuals who--
    (i) Receive SSI or SSP or both; and
    (ii) Are covered under the State's Medicaid plan as categorically 
needy.
    (2) Category B: Individuals who--
    (i) Under the Act or any other provision of Federal law are treated, 
for Medicaid eligibility purposes, as though they were receiving SSI or 
SSP; and
    (ii) Are covered under the State's Medicaid plan as categorically 
needy.
    (3) Category C: Individuals who are receiving AFDC.
    (4) Category D: Individuals who, under the Act or any other 
provision of Federal law, are treated, for Medicaid eligibility 
purposes, as though they were receiving AFDC.
    (5) Category E: Individuals who, in accordance with Sec. 435.114 or 
Sec. 435.134 of this chapter, are covered under the

[[Page 190]]

State's Medicaid plan despite the increase in social security benefits 
provided by Public Law 92-336.
    (6) Category F: Individuals who are Qualified Medicare 
Beneficiaries.1
---------------------------------------------------------------------------

    \1\ Rules for buy-in for premium hospital insurance for QMBs are set 
forth in Sec. 406.26 of this chapter.
---------------------------------------------------------------------------

    (7) Category G: All other individuals who are eligible for Medicaid.
    (b) Buy-in groups available. Any of the 50 States, the District of 
Columbia, and the Northern Mariana Islands may buy-in for one of the 
following groups:
    (1) Group 1: Categories A through G.
    (2) Group 2: Categories A through F.
    (3) Group 3: Categories A through E.
    (4) Group 4: Categories A, B, and F, individuals in categories C and 
D who are not social security or railroad retirement beneficiaries, and 
individuals in category E who are included in that category (in 
accordance with Sec. 435.134 of this chapter) because they received OAA, 
AB, APTD, or AABD in August 1972 or would have been eligible to receive 
such cash assistance for that month if they had applied or had not been 
institutionalized.
    (5) Group 5: Categories A and B, individuals in categories C and D 
who are not social security or railroad retirement beneficiaries, and 
individuals in category E who are included in that category (in 
accordance with Sec. 435.134 of this chapter) because they received OAA, 
AB, APTD, or AABD in August 1972 or would have been eligible to receive 
such cash assistance for that month if they had applied or had not been 
institutionalized.
    (6) Group 6: Categories A, B, and F, and individuals in category E 
who are included in that category (in accordance with Sec. 435.134 of 
this chapter) because they received AABD in August 1972 or would have 
been eligible to receive AABD for that month if they had applied or had 
not been institutionalized. This option is available only to those 
States that had an AABD program as of December 31, 1973.
    (7) Group 7: Categories A and B, and individuals in category E who 
are included in that category (in accordance with Sec. 435.134 of this 
chapter) because they received AABD in August 1972 or would have been 
eligible to receive AABD for that month if they had applied or had not 
been institutionalized. This option is available only to those States 
that had an AABD program as of December 31, 1973.

[56 FR 38081, Aug. 12, 1991]



Sec. 407.43  Buy-in groups available to Puerto Rico, Guam, the Virgin Islands, and American Samoa.

    (a) Categories included in buy-in groups. The buy-in groups that are 
available to Puerto Rico, Guam, the Virgin Islands, and American Samoa, 
which are not covered by the SSI program, are described in paragraph (b) 
of this section in terms of the following categories:
    (1) Category A: Individuals receiving OAA, AB, APTD, or AFDC.
    (2) Category B: Individuals who, under the Act or any other 
provision of Federal law, are treated, for Medicaid eligibility 
purposes, as though they were receiving AFDC.
    (3) Category C: Individuals who, in accordance with Sec. 436.112 of 
this chapter, are covered under the State's Medicaid plan despite the 
increase in social security benefits provided by Public Law 92-336.
    (4) Category D: Individuals who are Qualified Medicare 
Beneficiaries.1
---------------------------------------------------------------------------

    \1\ Rules for buy-in for premium hospital insurance for QMBs are set 
forth in Sec. 406.26 of this chapter.
---------------------------------------------------------------------------

    (5) Category E: All other individuals who are eligible for Medicaid.
    (b) Buy-in groups available. Puerto Rico, Guam, the Virgin Islands, 
and American Samoa may choose any of the following coverage groups:
    (1) Group 1: Categories A through E.
    (2) Group 2: Categories A through D.
    (3) Group 3: Categories A through C.
    (4) Group 4: Individuals in category D, and individuals in 
categories A and B who are not social security or railroad retirement 
beneficiaries.
    (5) Group 5: Individuals in categories A and B who are not social 
security or railroad retirement beneficiaries.
    (6) Group 6: Individuals in category D, individuals in category A 
who are receiving OAA, and individuals in category C who are included in 
that category (in accordance with Sec. 436.112 of this chapter) because 
they received

[[Page 191]]

OAA for August 1972 or would have been eligible to receive OAA for that 
month if they had applied or had not been institutionalized.
    (7) Group 7: Individuals in category A who are receiving OAA, and 
individuals in category C who are included in that category (in 
accordance with Sec. 436.112 of this chapter) because they received OAA 
for August 1972 or would have been eligible to receive OAA for that 
month if they had applied or had not been institutionalized.
    (8) Group 8: Individuals in category D and individuals in category A 
who are receiving OAA and are not social security or railroad retirement 
beneficiaries.
    (9) Group 9: Individuals in category A who are receiving OAA and are 
not social security or railroad retirement beneficiaries.

[56 FR 38082, Aug. 12, 1991]



Sec. 407.45  Termination of State buy-in agreements.

    (a) Termination by the State--(1) Termination after advance notice. 
A State may terminate its buy-in agreement after giving HCFA 3 months, 
advance notice.
    (2) Termination without advance notice. A State may terminate its 
buy-in agreement without advance notice if--
    (i) The State gives HCFA written certification to the effect that it 
is no longer legally able to comply with one or more of the provisions 
of the agreement; and
    (ii) Submits a supporting opinion from the appropriate State legal 
officer, if HCFA requests such an opinion.
    (b) Termination by HCFA. If HCFA, after giving the State notice and 
opportunity for hearing, finds that the State has failed to comply 
substantially with one or more of the provisions of the agreement, other 
than the requirement for timely payment of premiums, HCFA will give the 
State written notice to the effect that the agreement will terminate on 
the date indicated in the notice unless, before that date, HCFA finds 
that there is no longer that failure to comply. (Rules for collection of 
overdue premiums, including assessment of interest and offset against 
FFP due the State, are those set forth in the Notice published on 
September 30, 1985 at 50 FR 39784.)



Sec. 407.47  Beginning of coverage under a State buy-in agreement.

    (a) General rule. The beginning of an individual's coverage period 
depends on two factors:
    (1) The individual's meeting the SMI eligibility requirements and 
the requirements for being a member of the buy-in group; and
    (2) The effective date of the buy-in agreement or agreement 
modification that covers the group to which the individual belongs, and 
which may not be earlier than the third month after the month in which 
the agreement or modification is executed.
    (b) Application of general rule: Medicaid eligibles who are, or are 
treated as, cash assistance recipients. For Medicaid eligibles who are, 
or are treated as, cash assistance recipients (that is, are members of 
categories A through E of Sec. 407.42(a) or categories A through C of 
Sec. 407.43(a)), coverage begins with the later of the following:
    (1) The first month in which the individual--
    (i) Meets the SMI eligibility requirements specified in Sec. 407.10; 
and
    (ii) Is a member of one of those categories.
    (2) The month in which the buy-in agreement is effective.
    (c) Application of general rule: Qualified Medicare Beneficiaries. 
For individuals who are QMBs (that is, are members of category F of 
Sec. 407.42 or category D of Sec. 407.43(a)), coverage begins with the 
later of the following:
    (1) The first month in which the individual meets the SMI 
eligibility requirements specified in Sec. 407.10, and has QMB status.
    (2) The month in which the buy-in agreement or agreement 
modification covering QMBs is effective.
    (d) Application of general rule: Other individuals eligible for 
Medicaid. For individuals who are members of category G of 
Sec. 407.42(a) or category E of Sec. 407.43(a), coverage begins with the 
later of the following:
    (1) The second month after the month in which the individual--
    (i) Meets the SMI eligibility requirements specified in Sec. 407.10; 
and
    (ii) Is determined to be eligible for Medicaid.

[[Page 192]]

    (2) The month in which the buy-in agreement or agreement 
modification is effective.
    (e) Coverage based on erroneous report. If the State erroneously 
reports to SSA that an individual is a member of its coverage group, the 
rules of paragraphs (a) through (d) of this section apply, and coverage 
begins as though the individual were in fact a member of the group. 
Coverage will end only as provided in Sec. 407.48.

[56 FR 38082, Aug. 12, 1991]



Sec. 407.48  Termination of coverage under a State buy-in agreement.

    An individual's coverage under a buy-in agreement terminates with 
the earliest of the following events:
    (a) Death. Coverage ends on the last day of the month in which the 
individual dies.
    (b) Loss of entitlement to hospital insurance benefits before age 
65. If an individual loses entitlement to hospital insurance benefits 
before attaining age 65, coverage ends on the last day of the last month 
for which he or she is entitled to hospital insurance.
    (c) Loss of eligibility for the buy-in group. If an individual loses 
eligibility for inclusion in the buy-in group, buy-in coverage ends as 
follows:
    (1) On the last day of the last month for which he or she is 
eligible for inclusion in the group, if HCFA determines ineligibility or 
receives a State ineligibility notice by the 25th day of the second 
month after the month in which the individual becomes ineligible for 
inclusion in the group.
    (2) On the last day of the second month before the month in which 
HCFA receives a State ineligibility notice later than the time specified 
in paragraph (c)(1) of this section. A notice received by HCFA after the 
25th day of the month is considered to have been received in the 
following month.
    (d) Termination or modification of buy-in agreement. If the State's 
buy-in agreement is terminated, or modified to substitute a narrower 
buy-in group, coverage ends on the last day of the last month for which 
the agreement was in effect, or covered the broader buy-in group.

[53 FR 47204, Nov. 22, 1988, as amended at 56 FR 38082, Aug. 12, 1991]



Sec. 407.50  Continuation of coverage: Individual enrollment following end of coverage under a State buy-in agreement.

    (a) Deemed enrollment. When coverage under a buy-in agreement ends 
because the agreement terminates, or is modified to substitute a 
narrower buy-in group, or because the individual is no longer eligible 
for inclusion in the buy-in group, the individual--
    (1) Is considered to have enrolled during his or her initial 
enrollment period; and
    (2) Will be entitled to SMI on this basis and liable for SMI 
premiums beginning with the first month for which he or she is no longer 
covered under the buy-in agreement.
    (b) Voluntary termination. (1) An individual may voluntarily 
terminate entitlement acquired under paragraph (a) of this section by 
filing, with SSA or HCFA, a request for disenrollment.
    (2) Voluntary disenrollment is effective as follows:
    (i) If the individual files a request within 30 days after the date 
of HCFA's notice that buy-in coverage has ended, the individual's 
entitlement ends on the last day of the last month for which the State 
paid the premium.
    (ii) If the individual files the request more than 30 days but not 
more than 6 months after buy-in coverage ends, entitlement ends on the 
last day of the month in which the request is filed.
    (iii) If the individual files the request later than the 6th month 
after buy-in coverage ends, entitlement ends at the end of the month 
after the month in which request is filed.1
---------------------------------------------------------------------------

    \1\ For requests filed before July 1987, entitlement ended on the 
last day of the calendar quarter after the quarter in which the 
disenrollment request was filed.

[53 FR 47204, Nov. 22, 1988, as amended at 56 FR 38082, Aug. 12, 1991]

[[Page 193]]



PART 408--PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE--Table of Contents




                      Subpart A--General Provisions

Sec.
408.1  Statutory basis.
408.2  Scope and purpose.
408.3  Definitions.
408.4  Payment obligations.
408.6  Methods and priorities for payment.
408.8  Grace period and termination date.
408.10  Claim for monthly benefits pending concurrently with request for 
          SMI enrollment.

                  Subpart B--Amount of Monthly Premium

408.20  Monthly premiums.
408.22  Increased premiums for late enrollment and for reenrollment.
408.24  Individuals who enrolled or reenrolled before April 1, 1981 or 
          after September 30, 1981.
408.25  Individuals who enrolled or reenrolled between April 1 and 
          September 30, 1981.
408.26  Examples.
408.27  Rounding the monthly premium.

               Subpart C--Deduction From Monthly Benefits

408.40  Deduction from monthly benefits: Basic rules.
408.42  Deduction from railroad retirement benefits.
408.43  Deduction from social security benefits.
408.44  Deduction from civil service annuities.
408.45  Deduction from age 72 special payments.
408.46  Effect of suspension of social security benefits.
408.47  [Reserved]
408.50  When premiums are considered paid.
408.52  Change from direct remittance to deduction.
408.53  Change from partial direct remittance to full deduction.

            Subpart D--Direct Remittance: Individual Payment

408.60  Direct remittance: Basic rules.
408.62  Initial and subsequent billings.
408.63  Billing procedures when monthly benefits are less than monthly 
          premiums.
408.65  Payment options.
408.68  When premiums are considered paid.
408.70  Change from quarterly to monthly payments.
408.71  Change from deduction or State payment to direct remittance.

               Subpart E--Direct Remittance: Group Payment

408.80  Basic rules.
408.82  Conditions for group billing.
408.84  Billing and payment procedures.
408.86  Responsibilities under group billing arrangement.
408.88  Refund of group payments.
408.90  Termination of group billing arrangement.
408.92  Change from group payment to deduction or individual payment.

          Subpart F--Termination and Reinstatement of Coverage

408.100  Termination of coverage for nonpayment of premiums.
408.102  Reconsideration of termination.
408.104  Reinstatement procedures.

  Subpart G--Collection of Unpaid Premiums; Refund of Excess Premiums 
                     After the Death of the Enrollee

408.110  Collection of unpaid premiums.
408.112  Refund of excess premiums after the enrollee dies.

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

    Source: 52 FR 48115, Dec. 18, 1987, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 408.1  Statutory basis.

    (a) This part implements certain provisions of sections 1837 through 
1840 and 1881(d) of the Social Security Act (the Act) and conforms to 
other regulations that implement section 1843 of the Act. Section 
1838(b) requires regulations to establish when an individual's coverage 
ends because of nonpayment of premiums. It also specifies that those 
regulations may provide a grace period for payment of overdue premiums 
without loss of coverage. Section 1839 sets forth the specific 
procedures for determining the amount of the monthly premium and section 
1840 establishes the rules for payment of premiums. Section 1843 
provides that a State may enter into a buy-in agreement to secure SMI 
coverage for certain individuals by enrolling them in the SMI program 
and paying the premiums on their behalf. Section 1881(d) provides that 
Medicare payment, for the reasonable charges incurred in connection with 
a kidney donation, shall

[[Page 194]]

be made (without regard to deductible, premium, or coinsurance 
provisions of title XVIII) as prescribed in regulations.
    (b) The Federal Claims Collection Act (31 U.S.C. 3711), as 
implemented by 4 CFR parts 101-105, provides the basic authority for 
recovery of debts owed the United States government and specifies the 
conditions for the suspension or termination of collection action. 
Departmental regulations at 45 CFR part 30, updated by a final rule 
published on January 5, 1987 (52 FR 260) set forth procedures for the 
exercise of the Department's authority to collect and dispose of debts 
and were intended to complement rules applicable to particular programs. 
HCFA rules are set forth at 42 CFR part 401, subpart F.

[52 FR 48115, Dec. 18, 1987; 53 FR 4158, Feb. 12, 1988, as amended at 56 
FR 48112, Sept. 24, 1991]



Sec. 408.2  Scope and purpose.

    (a) This part sets forth the policies and procedures for determining 
the amount of monthly supplementary medical insurance (SMI) premiums, 
for the payment, collection, or refund of premiums, for termination of 
coverage because of nonpayment of premiums, and for reinstatement of 
coverage if certain conditions are met. It conforms to subpart C of part 
407 of this chapter, which sets forth the requirements for State buy-in 
agreements. These policies are intended to protect enrollee coverage to 
the maximum degree compatible with maintaining the integrity of the SMI 
program.
    (b) Policies that apply to premiums that certain individuals must 
pay in order to become entitled to Medicare Part A hospital insurance 
benefits, are set forth in part 406 of this chapter.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec. 408.3  Definitions.

    As used in this part, unless the context indicates otherwise--
    Enrollee means an individual who is enrolled in the SMI program 
under Medicare Part B.
    Taxable year means the 12-month period (calendar or fiscal year) for 
which the individual files his or her income tax return.



Sec. 408.4  Payment obligations.

    (a) Month for which payment is due. (1) A payment is due for each 
month, beginning with the first month of SMI coverage and continuing 
through the month of death or, if earlier, the month in which coverage 
terminates.
    (2) A premium is due for the month of death, if SMI coverage is 
still in effect, even though the individual dies on the first day of the 
month.
    (b) Overdue premiums. (1) Overdue premiums constitute an obligation 
enforceable against the enrollee or the enrollee's estate.
    (2) Overdue premiums are collected--
    (i) By deduction from social security or railroad retirement 
benefits or Federal civil service annuities;
    (ii) Directly from the enrollee or the enrollee's estate; or
    (iii) By offset against any SMI payments payable to the enrollee or 
the enrollee's estate.
    (3) Interest is not charged on overdue premiums, except under a 
State buy-in agreement, as provided in Sec. 408.6(c)(4).
    (c) Premiums not required for certain kidney donors. (1) No premiums 
are required for SMI benefits related to the donation of a kidney if the 
donor is not an enrollee.
    (2) A kidney donor who is an enrollee is not relieved of the 
obligation for premiums.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec. 408.6  Methods and priorities for payment.

    (a) Methods of payment--(1) General rules. Premiums are paid by one 
of the following four methods:
    (i) Payment by a State under a buy-in agreement.
    (ii) Deduction from monthly railroad retirement of social security 
cash benefits or Federal civil service annuities.
    (iii) Direct remittance on an individual basis, by or on behalf of 
the enrollee.
    (iv) Direct remittance on a group basis, by an employer, union, 
lodge or other organization, or by an entity of State or local 
government.

[[Page 195]]

    (2) Special situations. (i) If the monthly social security benefit 
or age 72 special benefit is less than the monthly premium, the benefit 
is withheld and the enrollee is required to pay the balance through 
direct remittance. (This situation may arise if the individual first 
becomes eligible for social security benefits after December 31, 1981, 
and is, therefore, not eligible for the fixed minimum, or receives age 
72 special benefits that are reduced because the individual receives a 
government pension.)
    (ii) If the monthly railroad retirement benefit or civil service 
annuity payment is less than the premium, the monthly payment is not 
withheld and the enrollee is required to pay the total premium by direct 
remittance.
    (b) Priorities for payment. (1) If an enrollee is enrolled under a 
State buy-in agreement--
    (i) SMI premiums may not be deducted from monthly cash benefits or 
annuities; and
    (ii) The enrollee may not be required to pay by direct remittance.
    (2) If an enrollee is not covered under a State buy-in agreement, 
but is receiving a monthly benefit or an annuity specified in paragraph 
(a)(1)(ii) of this section--
    (i) The premiums are deducted from that benefit or annuity; or
    (ii) If the monthly benefit or payment is less than the monthly 
premium, the rules of paragraph (a)(2) of this section apply.
    (3) If an enrollee is neither covered under a State buy-in 
agreement, nor receiving monthly benefits or annuity payments, the 
premiums must be paid totally by direct remittance.
    (c) Payment by a State under a buy-in agreement. (1) A buy-in 
agreement is an agreement under which a State, through enrollment and 
payment of SMI premiums, secures SMI benefits for individuals who are 
eligible for that program and also eligible for certain other cash or 
medical benefits. (Policies on enrollment under State buy-in agreements 
are contained in subpart C of part 407 of this chapter.)
    (2) The State pays the premiums for each month for which an 
individual is covered under the agreement.
    (3) If an individual's coverage under a State buy-in agreement 
terminates, his coverage continues on an individual enrollment basis. 
The premiums are then deducted from benefits, as set forth in subpart C 
of this part, or paid by direct remittance in accordance with subpart D 
or subpart E of this part.
    (4) Policy on collection of premiums from buy-in States is set forth 
in a Federal Register notice published on September 30, 1985 at 50 FR 
39784.



Sec. 408.8  Grace period and termination date.

    (a) Grace period. (1) For all initial premium payments (monthly or 
quarterly), and subsequent monthly or quarterly payments, the grace 
period ends with the last day of the third month after the billing 
month.
    (2) For payments required because the monthly benefit is less than 
the monthly premium, the grace period ends on April 30 of the year 
following the calendar year which the premiums are due.
    (b) Extension of grace period: Last day is nonwork day. If the last 
day of the grace period is a Saturday, Sunday, legal holiday, or a day 
that, by statute or executive order, is a nonwork day for Federal 
employees, the grace period is extended to the next succeeding work day.
    (c) Termination date. The end of the grace period is the termination 
date for SMI coverage if overdue premiums have not been paid by that 
date in accordance with Sec. 408.68.
    (d) Extension of grace period for good cause. (1) HCFA may reinstate 
entitlement, without interruption of coverage, if the individual shows 
good cause for failure to pay within the initial grace period, and pays 
all overdue premiums within three calendar months after the termination 
date.
    (2) Good cause will be found if the individual establishes, by a 
credible statement, that failure to pay premiums within the initial 
grace period was due to conditions over which he or she had no control, 
or which he or she could not reasonably have been expected to foresee.

[52 FR 48115, Dec. 18, 1987, as amended at 56 FR 48112, Sept. 24, 1991]

[[Page 196]]



Sec. 408.10  Claim for monthly benefits pending concurrently with request for SMI enrollment.

    (a) If it is clear that an individual who applies for social 
security or railroad retirement benefits and for SMI will be entitled to 
monthly benefits, the application for monthly benefits is processed 
simultaneously with the request for SMI enrollment.
    (1) If monthly benefits are paid, the SMI premiums are deducted from 
those benefits.
    (2) If monthly benefits are suspended (for instance, because the 
individual's earnings exceed the maximum allowed by law), the enrollee 
is billed for direct remittance.
    (b) If it is clear that an individual will be entitled to SMI, but 
there is substantial question as to eligibility for monthly benefits, 
the request for SMI enrollment is processed separately.
    (1) When SMI enrollment is approved, the enrollee is billed for 
direct remittance.
    (2) When the application for monthly benefits is adjudicated, the 
following rules apply:
    (i) If monthly benefits are paid, the SMI premiums are deducted from 
those benefits, with appropriate adjustments for any premiums already 
paid by direct remittance.
    (ii) If the application for monthly benefits is approved but the 
benefits are suspended, the grace period is as set forth in 
Sec. 408.8(a).
    (iii) If the application for monthly benefits is denied, the grace 
period is as set forth in Sec. 408.8(a)(1).

[52 FR 48115, Dec. 18, 1987, as amended at 56 FR 48112, Sept. 24, 1991]



                  Subpart B--Amount of Monthly Premiums



Sec. 408.20  Monthly premiums.

    (a) Statutory provisions. (1) The law established a monthly premium 
of $3 for the initial period of the program. It also set forth criteria 
and procedures for the Secretary to follow each December, beginning with 
December 1968, to determine and promulgate the standard monthly premium 
for the 12-month period beginning with July of the following year.
    (2) The law was amended in 1983 to require that the Secretary 
promulgate the standard monthly premium in September of that year, and 
each year thereafter, to be effective for the 12 months beginning with 
the following January.
    (3) The standard monthly premium applies to individuals who enroll 
during their initial enrollment periods. In other situations, that 
premium may be increased or decreased as specified in this subpart.
    (4) The law was further amended in 1984 to include a temporary 
``hold harmless'' provision (set forth in paragraph (e) of this 
section), that was subsequently extended and finally made permanent in 
1988.
    (b) Criteria and procedures for the period from July 1976 through 
December 1983, the period from January 1991 through December 1995, and 
for periods after December 1998. (1) For periods from July 1976 through 
December 1983 and after December 1998, the Secretary determines and 
promulgates as the standard monthly premium (for disabled as well as 
aged enrollees) the lower of the following:
    (i) The actuarial rate for the aged.
    (ii) The monthly premium promulgated the previous December for the 
year beginning July 1, increased by a percentage that is the same as the 
latest cost-of-living increase in old age insurance benefits that 
occurred before the current promulgation. (Because of the change in the 
effective dates of the premium amount (under paragraph (a)(2) of this 
section), there was no increase in the standard monthly premium for the 
period July 1983 through December 1983.)
    (2) For periods after December 1998, the Secretary determines the 
standard monthly premium in the manner specified in paragraph (b)(1) of 
this section, but promulgates it in September for the following calendar 
year.
    (3) The premiums for calendar years 1991 through 1995 are those 
amounts as specified by section 1839(e)(1)(B) of the Act as follows:
    (i) In 1991, $29.90;
    (ii) In 1992, $31.80;
    (iii) In 1993, $36.60;

[[Page 197]]

    (iv) In 1994, $41.10; and
    (v) In 1995, $46.10.
    (c) Premiums for calendar years 1984 through 1990 and 1996 through 
1998. For calendar years 1984 through 1990 and 1996 through 1998, the 
standard monthly premium for all enrollees--
    (1) Is equal to 50 percent of the actuarial rate for enrollees age 
65 or over, that is, is calculated on the basis of 25 percent of program 
costs without regard to any cost-of-living increase in old age insurance 
benefits; and
    (2) Is promulgated in the preceding September.
    (d) Limitation on increase of standard premium: 1987 and 1988. If 
there is no cost-of-living increase in old age or disability benefits 
for December 1985 or December 1986, the standard monthly premiums for 
1987 and 1988 (promulgated in September 1986 and September 1987, 
respectively) may not be increased.
    (e) Nonstandard premiums for certain cases--(1) Basic rule. A 
nonstandard premium may be established in individual cases only if the 
individual is entitled to old age or disability benefits for the months 
of November and December, and actually receives the corresponding 
benefit checks in December and January.
    (2) Special rules: Calendar years 1987 and 1988. For calendar years 
1987 and 1988, the following rules apply:
    (i) A nonstandard premium may be established if there is a cost-of-
living increase in old age or disability benefits but, because the 
increase in the standard premium is greater than the cost-of-living 
increase, the beneficiary would receive a lower cash benefit in January 
than he or she received in December.
    (ii) A nonstandard premium may not be established if the reduction 
in the individual's benefit would result, in whole or in part, from any 
circumstance other than the circumstance described in paragraph 
(e)(2)(i) of this section.
    (3) Special rule: Calendar years after 1988. (i) Beginning with 
calendar year 1989, a premium increase greater than the cost-of-living 
increase is still a prerequisite for a nonstandard premium.
    (ii) However, a nonstandard premium is not precluded solely because 
the cash benefit is further reduced as a result of government pension 
offset or workers' compensation payment.
    (4) Amount of nonstandard premium. The nonstandard premium is the 
greater of the following:
    (i) The premium paid for December.
    (ii) The standard premium promulgated for January, reduced as 
necessary to compensate for--
    (A) The fact that the cost-of-living increase was less than the 
increase in the standard premium; or
    (B) The further reduction in benefit because of government pension 
offset or workers' compensation payments.
    (5) Effective dates of nonstandard premium. A nonstandard premium 
established under this paragraph (e) continues in effect for the rest of 
the calendar year even if later there are retroactive adjustments in 
benefit payments. (The nonstandard premium could be affected by a 
determination that the individual had not established, or had lost, 
entitlement to monthly benefits for November or December, or both.)
    (6) Effect of late enrollment or reenrollment. A nonstandard premium 
is subject to increase for late enrollment or reenrollment as required 
under other sections of this subpart. The increase is computed on the 
basis of the standard premium and added to the nonstandard premium.

[56 FR 8839, Mar. 1, 1991, as amended at 59 FR 26959, May 25, 1994]



Sec. 408.22  Increased premiums for late enrollment and for reenrollment.

    For an individual who enrolls after expiration of his or her initial 
enrollment period or reenrolls after termination of a coverage period, 
the standard monthly premium determined under Sec. 408.20 is increased 
by ten percent for each full twelve months in the periods specified in 
Secs. 408.24 and 408.25.



Sec. 408.24  Individuals who enrolled or reenrolled before April 1, 1981 or after September 30, 1981.

    (a) Enrollment. For an individual who first enrolled before April 1, 
1981 or after September 30, 1981, the period includes the number of 
months elapsed between the close of the individual's initial enrollment 
period and the close

[[Page 198]]

of the enrollment period in which he or she first enrolled, and excludes 
the following:
    (1) The three months of January through March 1968, if the 
individual first enrolled before April 1968.
    (2) Any months before January 1973 during which the individual was 
precluded from enrolling or reenrolling by the 3-year limitation on 
enrollment or reenrollment that was in effect before October 30, 1972.
    (3) Any months in or before a period of coverage under a State buy-
in agreement.
    (4) For an individual under age 65, any month before his or her 
current continuous period of entitlement to hospital insurance.
    (5) For an individual age 65 or older, any month before the month he 
or she attained age 65.
    (6) For premiums due for months beginning with September 1984 and 
ending with May 1986, the following:
    (i) Any months after December 1982 during which the individual was--
    (A) Age 65 to 69;
    (B) Entitled to hospital insurance (Medicare Part A); and
    (C) Covered under a group health plan (GHP) by reason of current 
employment status.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec. 407.20 of this 
chapter.
    (7) For premiums due for months beginning with June 1986, the 
following:
    (i) Any months after December 1982 during which the individual was:
    (A) Age 65 or over; and
    (B) Covered under a GHP by reason of current employment status.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec. 407.20 of this 
chapter.
    (8) For premiums due for months beginning with January 1987, the 
following:
    (i) Any months after December 1986 and before October 1998 during 
which the individual was:
    (A) A disabled Medicare beneficiary under age 65;
    (B) Not eligible for Medicare on the basis of end stage renal 
disease, under Sec. 406.13 of this chapter; and
    (C) Covered under an LGHP as described in Sec. 407.20 of this 
chapter.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec. 407.20 of this 
chapter.
    (9) For premiums due for months beginning with July 1990, the 
following:
    (i) Any months after December 1986 during which the individual met 
the conditions of paragraphs (a)(8)(i)(A) and (a)(8)(i)(B) of this 
section, and was covered under a GHP by reason of the current employment 
status of the individual or the individual's spouse.
    (ii) Any months of SMI coverage for which the individual enrolled 
during a special enrollment period as provided in Sec. 407.20 of this 
chapter.
    (b) Reenrollment. For an individual who reenrolled before April 1, 
1981 or after September 30, 1981, the period:
    (1) Includes the following:
    (i) The number of months elapsed between the close of the 
individual's initial enrollment period and the close of the enrollment 
period in which he or she first enrolled; plus
    (ii) The number of months elapsed between the individual's initial 
period of coverage and the close of the enrollment period in which he or 
she reenrolled; plus
    (iii) The number of months elapsed between each subsequent period of 
coverage and the close of the enrollment period in which he or she 
reenrolled.
    (2) Excludes the following:
    (i) The periods specified in paragraphs (a)(1) through (a)(9) of 
this section; and
    (ii) Any month before April 1981 during which the individual was 
precluded from reenrolling by the two-enrollment limitation in effect 
before that date.

[52 FR 48118, Dec. 18, 1987, as amended at 53 FR 6648, Mar. 2, 1988; 61 
FR 40347, Aug. 2, 1996]



Sec. 408.25  Individuals who enrolled or reenrolled between April 1 and September 30, 1981.

    (a) Basic rules. Except as specified in paragraph (b) of this 
section, the rules set forth in Sec. 408.24 apply to an individual who 
enrolled or reenrolled between April 1 and September 30, 1981.
    (b) Exception. For an individual who enrolled or reenrolled between 
April 1 and September 30, 1981, the months to

[[Page 199]]

be counted ran through the month in which he or she reenrolled. (During 
those 6 months, continuous open enrollment was in effect and there was 
no 3-month ``general enrollment period''.)



Sec. 408.26  Examples.

    Example 1. Mr. J, who became age 65 and otherwise eligible for 
enrollment in November 1965, first enrolls in March 1968. The months to 
be included in determining the amount of the increase in Mr. J's 
premiums begin with June 1966 (the first month after the close of his 
initial enrollment period) and extend through December 1967 (the period 
January through March of 1968 is excluded in determining the total 
months) for a total of 19 months. Since there is only one full 12-month 
period in 19 months, Mr. J's premiums will be 10 percent greater than if 
he had enrolled in his initial enrollment period.
    Example 2. Mr. V, who enrolled in December 1965, voluntarily 
terminates his enrollment effective midnight December 31, 1967. He 
enrolls for a second time in January 1969. The months to be included in 
determining the amount of the increase in Mr. V's premiums are January 
1968 through March 1969, a total of 15 months. Since this totals one 
full 12-month period. Mr. V's monthly premium, will be increased by 10 
percent.
    Example 3. Ms. N becomes age 65 in July 1965 and first enrolls in 
December 1967. She pays premiums increased by 10 percent above the 
regular rate, beginning July 1968, the first month of her SMI coverage. 
Ms. N fails to pay the premiums for the calendar quarter ending June 30, 
1970, and her coverage is terminated on that date, the end of her grace 
period. Ms. N enrolls for a second time in January 1971. The months to 
be included in determining the amount of the increase in Ms. N's 
premiums are June 1966 through December 1967, a total of 19 months, and 
July 1970 through March 1971, a total of 9 months, for a grand total of 
28 months. Since this totals two full 12-month periods, Ms. N's monthly 
premium will be increased by 20 percent.
    Example 4. Mr. X attained age 65 in August 1966 and enrolled during 
his initial enrollment period. His coverage was terminated effective 
June 30, 1968, for nonpayment of premiums. He reenrolls in March 1973. 
For purposes of computing any applicable premium increase, he will not 
be charged any months between March 1971 (the end of the last general 
enrollment period during which he was eligible to reenroll under the law 
in effect before October 30, 1972) and January 1973. Therefore, he will 
be charged 36 months (July 1968-March 1971 plus January 1973-March 1973) 
and his premiums for his second period of coverage will be increased 30 
percent.
    Example 5. Ms. C, who attained age 65 in August 1973, had two 
periods of supplementary medical insurance coverage, both of which were 
terminated because of nonpayment of premiums: August 1973 through April 
1975 and July 1977 through August 1978. She reenrolls in July 1981. The 
months to be included in determining the amount of premium increase are 
May 1975 through March 1977 (23 months) and April 1981 through July 1981 
(4 months) for a total of 27 months. The 31 months from September 1978 
through March 1981 may not be counted because Ms. C was prevented from 
reenrolling by the two-enrollment limitation in effect before April 1, 
1981. For Ms. C, the standard monthly premium would be increased by 20 
percent.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



Sec. 408.27  Rounding the monthly premium.

    Any monthly premium that is not a multiple of 10 cents is rounded to 
the nearest multiple of 10 cents, and any odd mulitple of 5 cents is 
rounded to the next higher multiple of 10 cents.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988]



               Subpart C--Deduction From Monthly Benefits



Sec. 408.40  Deduction from monthly benefits: Basic rules.

    (a) Deduction from monthly benefits. (1) Enrollees who are receiving 
monthly benefits do not have the option of paying by direct remittance 
to avoid deduction.

[[Page 200]]

    (2) If the enrollee is entitled to more than one type of monthly 
benefit, the order of priority for deduction is as follows:
    (i) Railroad retirement benefits.
    (ii) Social security benefits.
    (iii) Civil service annuities.
    (b) Deduction from initial or reinstated benefits. When an enrollee 
receives a monthly benefit check after an initial award or after a 
period of suspension, that check is, if administratively feasible, 
reduced or increased to deduct unpaid premiums or refund premiums paid 
in advance by direct remittance.
    (c) Ongoing deductions. The premium for each month is deducted from 
the cash benefit for the preceding month, e.g., the premium for March is 
deducted from the benefit for February, which is paid at the beginning 
of March.



Sec. 408.42  Deduction from railroad retirement benefits.

    (a) Responsibility for deductions. If an enrollee is entitled to 
railroad retirement benefits, his or her SMI premiums are deducted from 
those benefits by the Railroad Retirement Board (RRB) even though he or 
she is also entitled to social security benefits or a civil service 
annuity, or both.
    (b) Action when benefits are suspended. If the railroad retirement 
benefits are suspended, the RRB sends premium notices requesting direct 
remittance, to be made in accordance with the rules set forth in Subpart 
D of this part.



Sec. 408.43  Deduction from social security benefits.

    SSA, acting as HCFA's agent, deducts the premiums from the monthly 
social security benefits if the enrollee is not entitled to railroad 
retirement benefits. (If the benefit is less than the monthly premium, 
the benefit is withheld and the enrollee is required to pay the balance 
through direct remittance.)



Sec. 408.44  Deduction from civil service annuities.

    (a) Responsibility for deductions. If an enrollee is not entitled to 
railroad retirement benefits or social security benefits, and is 
receiving a civil service annuity, the premiums are deducted from that 
annuity by the Office of Personnel Management (OPM) on the basis of a 
notice from SSA indicating that the annuitant is entitled to SMI.
    (b) Deduction of spouse's premiums. If the annuitant's spouse is 
also enrolled for SMI and is not entitled to a civil service annuity or 
to social security or railroad retirement benefits, and the annuitant 
gives written consent, OPM also deducts the spouse's premium from the 
annuitant's monthly check.
    (c) Withdrawal of annuitant's consent. (1) If an annuitant wishes to 
withdraw consent for deduction of the spouse's premium, he or she must 
send written notice of withdrawal to OPM.
    (2) The withdrawal notice is effective with the third month after 
the month in which it is received, or with the month specified in the 
notice, whichever is later.



Sec. 408.45  Deduction from age 72 special payments.

    (a) Deduction of premiums. SMI premiums are deducted from age 72 
special payments made under section 228 of the Act or the payments are 
withheld under procedures that correspond to the rules set forth in 
Secs. 408.40 and 408.43.
    (b) Collection of premiums while age 72 special payments are 
suspended. If the age 72 special payments are suspended, HCFA or its 
agent notifies the enrollee to pay premiums by direct remittance, in 
accordance with the rules set forth in Sec. 408.60.
    (c) Grace period. The grace period ends with the last day of the 
third month after the billing month.
    (d) Resumption of age 72 special payments. (1) If age 72 special 
payments are resumed before the end of the grace period and all premium 
arrears can be deducted from those special payments, SMI coverage 
continues and the enrollee need not pay by direct remittance.
    (2) Subsequent special payments are reduced by the amount of the 
premium for as long as the enrollee receives special payments.



Sec. 408.46  Effect of suspension of social security benefits.

    (a) Benefit payments to be resumed during the taxable year. (1) If 
social security benefit payments are scheduled to

[[Page 201]]

be resumed during the enrollee's current taxable year, the enrollee is 
not billed.
    (2) The enrollee may, if he or she wishes, pay the premiums during 
suspension of benefits.
    (b) Benefit payments not to be resumed during the enrollee's current 
taxable year. (1) If social security benefits are suspended for a period 
that will not permit collection of all premiums due from monthly 
benefits payable in the enrollee's current taxable year, HCFA or its 
agents bill the enrollee and require direct remittance in accordance 
with subpart D of this part.
    (2) The first billing is for whatever premiums are necessary to 
place the enrollee in a quarterly cycle.
    (3) Thereafter, the billing is on a quarterly basis. (Quarters for 
different enrollees are staggered throughout the year.)
    (4) The enrollee has the option of paying premiums for more than one 
quarter at the same time.



Sec. 408.47  [Reserved]



Sec. 408.50  When premiums are considered paid.

    (a) Actual deduction. A premium is considered paid if it is actually 
deducted from a monthly benefit check. Therefore--
    (1) The premium is ``paid'' even if SSA later finds that the benefit 
was paid in error; but
    (2) A finding that a monthly benefit was erroneously withheld does 
not constitute payment of the premium for that month. Since there was no 
payment, there was no deduction. The enrollee is billed and continuance 
of coverage depends on payment of premiums before the end of the grace 
period or extended grace period.
    (b) Payment within the grace period. Overdue premiums are considered 
paid within the grace period in the following situations:
    (1) Benefits are resumed during the grace period. (i) Monthly cash 
benefit payments are payable for the last month of the initial grace 
period or for earlier months on the basis of a notice filed by the 
enrollee before the initial grace period ends; and
    (ii) Those payments are sufficient to permit deduction of all 
overdue premiums.
    (2) Annual earnings report or other report submitted during the 
grace period shows a benefit is due. (i) Before the end of the grace 
period, the enrollee submits a report clearly showing that monthly cash 
benefits, previously withheld, are payable; and
    (ii) Those benefits are sufficient to permit deduction of the full 
amount of the overdue premiums.
    (3) Premium arrears are paid by direct remittance. The enrollee 
makes a direct remittance payment of all overdue premiums before the end 
of the grace period.

[52 FR 48115, Dec. 18, 1987; 53 FR 4159, Feb. 12, 1988; 56 FR 48112, 
Sept. 24, 1991]



Sec. 408.52  Change from direct remittance to deduction.

    If a direct remittance enrollee becomes entitled to monthly 
benefits--
    (a) The SMI premiums are deducted from those benefits; and
    (b) The enrollee is notified of the deduction and of any adjustment 
of the initial benefit check that is required to collect overdue 
premiums or refund premiums paid in advance.



Sec. 408.53  Change from partial direct remittance to full deduction.

    If a benefit that was less than the premium (and therefore required 
direct remittance of the difference) is increased to an amount equal to, 
or greater than, the premium--
    (a) The full premium is paid from the benefit; and
    (b) Any amounts the enrollee had paid toward premiums not yet due 
are refunded.



            Subpart D--Direct Remittance: Individual Payment



Sec. 408.60  Direct remittance: Basic rules.

    (a) Premiums not deducted from monthly benefits under Subpart C of 
this part or paid by a State buy-in agreement must be paid by direct 
remittance to HCFA or its agents, by or on behalf of the enrollee.

[[Page 202]]

    (b) Quarterly payment is preferred as more cost-effective, but 
monthly payment is accepted if the enrollee is unwilling or unable to 
make quarterly payments or is also paying hospital insurance premiums, 
which must be paid every month.
    (c) HCFA, directly or through its agents, sends quarterly or monthly 
premium bills and includes an addressed return envelope with the bill.
    (d) The individual must--
    (1) Send a check or money order that is drawn payable to ``HCFA 
Medicare Insurance'' and show the enrollee's name and claim number as it 
appears on the Medicare card; and
    (2) Return the bill with the check or money order in the 
preaddressed envelope.



Sec. 408.62  Initial and subsequent billings.

    (a) Monthly billing. (1) The first premium bill is for the period 
from the first month of coverage (or the first month of change from 
deduction or State buy-in payment) through the end of the first month 
after the month of billing.
    (2) Subsequent billings are for periods of one month.
    (b) Quarterly billing. (1) The first premium bill is for the period 
from the first month of coverage (or of change from deduction or State 
buy-in payment) through the third month after the month of billing.
    (2) Subsequent billings are for periods of three months.



Sec. 408.63  Billing procedures when monthly benefits are less than monthly premiums.

    If monthly benefits are less than monthly premiums, the following 
procedures apply:
    (a) Notice of amount due. At the beginning of SMI entitlement, and 
at the beginning of each succeeding calendar year, SSA--
    (1) Notifies the enrollee of the amount of benefits payable for the 
rest of the year and the total premiums due for those same months; and
    (2) Bills the enrollee for the difference.
    (b) Notice of amount overdue. At the beginning of each succeeding 
calendar year, SSA--
    (1) Notifies the enrollee of any amounts overdue for premiums for 
the preceding calendar year; and
    (2) Indicates that if the amount still overdue on April 30 is equal 
to or greater than the premium for 3 months, SMI coverage will terminate 
on that date.



Sec. 408.65  Payment options.

    (a) The enrollee is not asked to pay premiums at the time of 
enrollment but is instructed to pay them upon receipt of a premium bill 
from HCFA or its agents.
    (b) However, if the enrollee wishes, he or she may pay from one to 
12 months or from one to four quarters at the time of enrollment.



Sec. 408.68  When premiums are considered paid.

    (a) Payment by check. The premium is considered paid if the check is 
paid by the bank the first or second time it is presented for payment.
    (b) Payment within the grace period. (1) A premium is considered 
paid within the grace period if it is delivered personally, or mailed on 
or before the last day of that period.
    (2) A premium payment is considered to have been mailed 7 days 
before it is received by HCFA.



Sec. 408.70  Change from quarterly to monthly payments.

    If an enrollee requests change from quarterly to monthly payment--
    (a) If the enrollee is paid up under the quarterly cycle, the first 
monthly bill is for one month.
    (b) If the enrollee is not paid up under the quarter system, the 
first bill includes all premiums due.



Sec. 408.71  Change from deduction or State payment to direct remittance.

    (a) Basis for change. An SMI enrollee is required to pay by direct 
remittance in any of the following circumstances:
    (1) The enrollee's entitlement to social security or railroad 
retirement benefits ends for any reason other than death.

[[Page 203]]

    (2) The premiums can no longer be deducted from the civil service 
annuity of the enrollee or the enrollee's spouse.
    (3) The enrollee no longer qualifies for coverage under a State buy-
in agreement, and is not entitled to social security or railroad 
retirement monthly benefits.
    (b) Billing. When any of the events specified in paragraph (a) of 
this section occurs (or as soon thereafter as possible), HCFA or its 
agents bill the enrollee for direct remittance, in accordance with this 
subpart.



               Subpart E--Direct Remittance: Group Payment



Sec. 408.80  Basic rules.

    (a) Sources of group payment. An employer, a lodge, union, or other 
organization may pay SMI premiums on behalf of one or more enrollees.
    (b) Informal arrangement. Enrollees may turn over their premium 
notices to their employer, union, lodge, or other organization and that 
organization may send a single payment (with the premium notices 
attached so that the payments can readily be identified with the 
appropriate enrollees) to the HCFA Premium Collection Center. Prompt 
payment is essential since SMI coverage terminates if premiums are not 
paid by the end of the grace period.
    (c) Group billing arrangement. HCFA may send a single notice for the 
premiums due from a group of enrollees if the following conditions are 
met:
    (1) The group payer--
    (i) Uses funds other than the enrollees' to pay all or a substantial 
part of the premiums; or
    (ii) Deducts the premiums from periodic payments it makes to the 
enrollees in the group.
    (2) The enrollee's rights are protected and enrollees are not 
required to pay the costs of having their premiums paid on a group 
basis.



Sec. 408.82  Conditions for group billing.

    HCFA agrees to a group billing arrangement only if the following 
conditions are met:
    (a) Conditions the group payer must meet. The group payer submits a 
written request for group billing--
    (1) Showing that all or part of the payments are made from the 
payer's funds or from funds due the enrollees and in the payer's 
possession; and
    (2) Agreeing not to charge the enrollees for the service of paying 
the premiums or for the administrative costs such as recordkeeping and 
postage.
    (b) Enrollees eligible for group payment. (1) Group payment may be 
made only on behalf of individuals who are already enrolled and are 
being billed for direct remittance.
    (2) Group payment may not be made for enrollees whose premiums are 
being deducted from monthly benefits in accordance with Subpart C of 
this part or being paid by the State under a buy-in agreement.
    (c) Protection of enrollee's rights. The use of group billing must 
not jeopardize the enrollees' right--
    (1) To confidentiality of personal information;
    (2) To terminate enrollment;
    (3) To resume individual payment of premiums if he or she wishes; 
and
    (4) To receive notice of any action that affects the SMI benefits.
    (d) Authorization by the enrollee. (1) To ensure maximum feasible 
protection of the rights specified in paragraph (c) of this section, 
each enrollee must give written authorization as specified in 
Sec. 408.84(a)(2).
    (2) A group payer that is not an entity of State or local government 
must submit all enrollee authorizations to HCFA.
    (3) A group payer that is an entity of State or local government may 
retain the authorizations and certify to HCFA that it has on file an 
authorization for each enrollee included in the group.
    (4) It is on the basis of the enrollee's authorization that HCFA 
sends the group payer information about each enrollee, as necessary to 
carry out the group payment function.
    (e) Size of group. The number of enrollees must be at least 20, 
which is the minimum size sufficient to make group billing efficient. 
(Smaller groups may use the informal procedure described in 
Sec. 408.80(b).)

[[Page 204]]



Sec. 408.84  Billing and payment procedures.

    (a) Initial premium notice. (1) HCFA or its agent always sends the 
initial premium notice to the enrollee.
    (2) An enrollee who wishes to have the premiums paid on a group 
basis must give the notice to the group payer, along with written 
authorization for sending subsequent notices to the group payer and for 
release of the information required for the group payment process.
    (b) Monthly billings. Group premiums are billed on a monthly basis. 
However, the group payer may pay up to 12 months in advance.
    (c) Group payers must make their payments within 30 days after 
billing, to avoid infringing on the 90-day grace period during which the 
premiums may be paid by the enrollee if he or she is dropped from the 
group.
    (d) Effect of group payment. Payment by a group payer is considered 
payment by the enrollee.



Sec. 408.86  Responsibilities under group billing arrangement.

    (a) Enrollee responsibilities. (1) The enrollee is still responsible 
for premium payments; the group payer simply acts as his agent. If the 
agent fails to pay, or identifies the payment incorrectly, SSA notifies 
both the agent and the enrollee that the enrollee's account is 
delinquent. If an enrollee fails to take action on that notice, 
entitlement is terminated for nonpayment of premiums.
    (2) The enrollee must promptly notify both SSA and the group payer 
of any change of address.
    (b) Group payer's responsibilities. The group payer must--
    (1) Make premium payments promptly upon receipt of notices;
    (2) Promptly notify both HCFA and the enrollee when it drops an 
enrollee from the group;
    (3) Make payments in a way that facilitates efficient and economical 
processing; and
    (4) Maintain the confidentiality of the personal information 
obtained from HCFA for the group payment process.
    (c) HCFA responsibilities. HCFA--
    (1) Sends the bill to the group payer upon authorization from the 
enrollee;
    (2) Notifies both the payer and the enrollee if the payer fails to 
make timely payments; and
    (3) Refunds excess premiums in accordance with Sec. 408.88.



Sec. 408.88  Refund of group payments.

    (a) Basis for refund. Group payments are refunded only in the 
following circumstances:
    (1) The premium was for a month after the month in which the 
enrollee's SMI coverage terminated or the enrollee died.
    (2) The premium was for a month after the month in which the group 
payer gave notice (before the 26th day of that month) that the enrollee 
was no longer eligible for group payment and was being dropped from the 
group.
    (b) Example. F is the wife of J who is a retiree of Corporation X. 
That corporation pays premiums on behalf of all of its retirees and 
their dependents. F obtains a divorce from J on October 20 and thus 
disqualifies herself for further premium payments by the corporation. 
The corporation gives notice on November 10 that a refund is due because 
F has been dropped from the list of persons for whom it has agreed to 
pay premiums. The premium paid for December would be refunded to the 
group payer.
    (c) To whom refund is made. (1) HCFA ordinarily refunds to the group 
payer the premiums specified in paragraph (a) of this section.
    (2) However, if HCFA has information that clearly shows those 
premiums were paid from the enrollee's funds, it sends the refund to the 
enrollee.



Sec. 408.90  Termination of group billing arrangement.

    (a) A group billing arrangement may be terminated either by the 
group payer or by HCFA upon 30 days' notice.
    (b) HCFA may terminate the arrangement if it finds that the group 
payer is not acting in the best interest of the enrollees or that, for 
any other reason, the arrangement has proved inconvenient for HCFA.



Sec. 408.92  Change from group payment to deduction or individual payment.

    (a) Enrollee excluded from group payment arrangement because of 
entitlement

[[Page 205]]

to monthly benefits. (1) When an enrollee becomes entitled to monthly 
benefits from which premiums can be deducted as specified in subpart C 
of this part, HCFA notifies the group payer to discontinue payment for 
that enrollee.
    (2) In order to maintain confidentiality, HCFA does not explain to 
the group payer the reason for excluding the enrollee from the group 
payment arrangement.
    (3) The enrollee's premiums are thereafter deducted from the monthly 
benefits, in accordance with subpart C of this part.
    (b) Enrollee no longer eligible for the group. (1) When an enrollee 
is no longer eligible to be included in the group (for instance because 
he or she is no longer employed by the group payer or has terminated 
union or lodge membership), the group payer must promptly notify HCFA 
and the enrollee.
    (2) HCFA or its agents resume sending individual bills to the 
enrollee, for direct remittance subject to the grace period and 
termination dates specified in Sec. 408.8.



          Subpart F--Termination and Reinstatement of Coverage



Sec. 408.100  Termination of coverage for nonpayment of premiums.

    (a) Effective date of termination. Termination is effective on the 
last day of the grace period. The determination is not made until 15 
days after that day to allow for processing of remittances mailed late 
in the grace period, as provided in Sec. 408.68.
    (b) Notice of termination. (1) SSA sends the enrollee notice of 
termination between 15 and 30 days after the end of the grace period and 
includes information regarding the enrollee's right of appeal.
    (2) HCFA notifies any intermediary or carrier that had previously 
been informed that the enrollee had met the SMI deductible for the year 
in which the termination is effective.



Sec. 408.102  Reconsideration of termination.

    (a) Basic rules. Coverage may be reinstated without interruption of 
benefits if the following conditions are met:
    (1) The enrollee appeals the termination by the end of the month 
following the month in which SSA sent the notice of termination.
    (2) The enrollee alleges and it is found that the enrollee did not 
receive timely and adequate notice that the premiums were overdue.
    (3) The enrollee pays, within 30 days after SSA's subsequent request 
for payment, all premiums due through the month in which he or she 
appealed the termination.
    (b) Basis for reinstating coverage. Coverage may be reinstated if 
the evidence establishes one of the following:
    (1) The enrollee acted diligently to pay the premiums or to request 
relief upon receiving a premium notice very late in the grace period or 
shortly after its end, and the delayed notice was not the enrollee's 
fault. (For example, if the billing notice was misaddressed or lost in 
the mail, it would not be the enrollee's fault; if the enrollee had 
moved and not notified SSA of the new address, he or she would be 
responsible for the delay.)
    (2) On the basis of information given by SSA, the enrollee could 
reasonably have believed that the premiums were being paid by deduction 
from benefits or by some other means. (An example would be a notice 
indicating that premiums would be paid by a State Medicaid agency or a 
group payer or would be deducted from the spouse's civil service 
annuity.)
    (c) No basis for reinstating coverage. Coverage may not be 
reinstated if the enrollee--
    (1) Received timely and adequate notice but failed to pay within the 
grace period, for example because of insufficient income or resources; 
or
    (2) Appealed the termination more than one month after the month in 
which SSA sent the termination notice.



Sec. 408.104  Reinstatement procedures.

    (a) Request for payment. If the conditions of Sec. 408.102(a) (1) 
and (2) are met, SSA sends written notice requesting the enrollee to 
pay, within 30 days, all premiums due through the month in which the 
enrollee appealed the termination.

[[Page 206]]

    (b) Reinstatement of coverage. If SSA receives the requested payment 
within 30 days, it sets aside the termination and reinstates the 
enrollee's coverage without interruption.



  Subpart G--Collection of Unpaid Premiums; Refund of Excess Premiums 
                     After the Death of the Enrollee



Sec. 408.110  Collection of unpaid premiums.

    (a) Basis and scope--(1) Basis. Under the Federal Claims Collection 
Act of 1966 (31 U.S.C. 3711), HCFA is required to collect any debts due 
it but is authorized to suspend or terminate collection action on debts 
of less than $20,000 when certain conditions are met. (See 4 CFR, parts 
101-105 for general rules implementing the Federal Claims Collection 
Act.) As indicated in Sec. 408.4, unpaid premiums are debts owed the 
Federal government by the enrollee or the enrollee's estate.
    (2) Scope. This section sets forth the methods of collection used by 
HCFA and the circumstances under which HCFA terminates or renews 
collection action. The regulations in this section apply to hospital 
insurance premiums as well as SMI premiums.
    (b) Collection of unpaid premiums. Generally, HCFA will attempt to 
collect unpaid premiums by one of the following methods:
    (1) By billing enrollees who pay the premiums directly to HCFA or to 
a designated agent in accordance with Sec. 408.60.
    (2) By deduction from any benefits payable to the enrollee or the 
estate of a deceased enrollee under Title II or XVIII of the Social 
Security Act, the Railroad Retirement Act or any act administered by the 
Office of Personnel Management in accordance with Sec. 408.4(b) and 
Subpart C of this part (Deduction from Monthly Benefits); or
    (3) By billing the estate of a deceased enrollee.
    (c) Termination of collection action. HCFA terminates collection 
action on unpaid premiums under either of the following circumstances, 
if the cost of collection exceeds the amount of overdue premiums:
    (1) The individual is not entitled to benefits under the Acts listed 
in paragraph (b)(2) of this section, is not currently enrolled for SMI 
or premium hospital insurance, and demonstrates, to HCFA's satisfaction, 
that he or she is unable to pay the debt within a reasonable time.
    (2) The individual has been dead more than 27 months (the maximum 
time allowed for claiming SMI benefits), and the legal representative of 
his or her estate demonstrates, to HCFA's satisfaction, that the estate 
is unable to pay the debt within a reasonable time.
    (d) Renewal of collection efforts. HCFA renews collection efforts in 
either of the following circumstances, if the cost of collection does 
not exceed the amount of the overdue premiums:
    (1) The individual enrolls again for premium hospital insurance or 
SMI. (Payment of overdue premiums is not a prerequisite for 
reenrollment.)
    (2) The individual becomes entitled or reentitled to social security 
or railroad retirement benefits or a Federal civil service annuity.



Sec. 408.112  Refund of excess premiums after the enrollee dies.

    If HCFA has received premiums for months after the enrollee's death, 
HCFA refunds those premiums as follows:
    (a) To the person or persons who paid the premiums or, if the 
premiums were paid by the enrollee, to the representative of the 
enrollee's estate, if any.
    (b) If refund cannot be made under paragraph (a) of this section, 
HCFA refunds the premiums to the enrollee's survivors in the following 
order of priority:
    (1) The surviving spouse, if he or she was either living in the same 
household with the deceased at the time of death, or was, for the month 
of death, entitled to monthly social security or railroad retirement 
benefits on the basis of the same earnings record as the deceased 
beneficiary;
    (2) The child or children who were, for the month of death, entitled 
to monthly social security or railroad retirement benefits on the basis 
of the same earnings record as the deceased (and, if there is more than 
one child, in equal parts to each child);

[[Page 207]]

    (3) The parent or parents who were, for the month of death, entitled 
to monthly social security or railroad retirement benefits on the basis 
of the same earnings record as the deceased (and, if there is more than 
one parent, in equal parts to each parent);
    (4) The surviving spouse who was not living in the same household 
with the deceased at the time of death and was not, for the month of 
death, entitled to monthly social security or railroad retirement 
benefits on the basis of the same earnings record as the deceased 
beneficiary;
    (5) The child or children who were not entitled to monthly social 
security or railroad retirement benefits on the basis of the same 
earnings record as the deceased (and, if there is more than one child, 
in equal parts to each child);
    (6) The parent or parents who were not entitled to monthly social 
security or railroad retirement benefits on the basis of the same 
earnings record as the deceased (and, if there is more than one parent, 
in equal parts to each parent).

If none of the listed relatives survives, no refund can be made.



PART 409--HOSPITAL INSURANCE BENEFITS--Table of Contents




       Subpart A--Hospital Insurance Benefits: General Provisions

Sec.
409.1  Statutory basis.
409.2  Scope.
409.3  Definitions.
409.5  General description of benefits.

  Subpart B--Inpatient Hospital Services and Inpatient Critical Access 
                            Hospital Services

409.10  Included services.
409.11  Bed and board.
409.12  Nursing and related services; medical social services; use of 
          hospital or CAH facilities.
409.13  Drugs and biologicals.
409.14  Supplies, appliances, and equipment.
409.15  Services furnished by an intern or a resident-in-training.
409.16  Other diagnostic or therapeutic services.
409.18  Services related to kidney transplantations.
409.19  Services related to cardiac pacemakers and pacemaker leads.

                    Subpart C--Posthospital SNF Care

409.20  Coverage of services.
409.21  Nursing care.
409.22  Bed and board.
409.23  Physical, occupational, and speech therapy.
409.24  Medical social services.
409.25  Drugs, biologicals, supplies, appliances, and equipment.
409.26  Transfer agreement hospital services.
409.27  Other services generally provided by (or under arrangements made 
          by) SNFs.

      Subpart D--Requirements for Coverage of Posthospital SNF Care

409.30  Basic requirements.
409.31  Level of care requirement.
409.32  Criteria for skilled services and the need for skilled services.
409.33  Examples of skilled nursing and rehabilitation services.
409.34  Criteria for ``daily basis''.
409.35  Criteria for ``practical matter''.
409.36  Effect of discharge from posthospital SNF care.

        Subpart E--Home Health Services Under Hospital Insurance

409.40  Basis, purpose, and scope.
409.41  Requirement for payment.
409.42  Beneficiary qualifications for coverage of services.
409.43  Plan of care requirements.
409.44  Skilled services requirements.
409.45  Dependent services requirements.
409.46  Allowable administrative costs.
409.47  Place of service requirements.
409.48  Visits.
409.49  Excluded services.
409.50  Coinsurance for durable medical equipment (DME) furnished as a 
          home health service.

             Subpart F--Scope of Hospital Insurance Benefits

409.60  Benefit periods.
409.61  General limitations on amounts of benefits.
409.62  Lifetime maximum on inpatient psychiatric care.
409.63  Reduction of inpatient psychiatric benefit days available in the 
          initial benefit period.
409.64  Services that are counted toward allowable amounts.
409.65  Lifetime reserve days.
409.66  Revocation of election not to use lifetime reserve days.
409.68  Guarantee of payment for inpatient hospital or inpatient CAH 
          services furnished before notification of exhaustion of 
          benefits.

[[Page 208]]

        Subpart G--Hospital Insurance Deductibles and Coinsurance

409.80  Inpatient deductible and coinsurance: General provisions
409.82  Inpatient hospital deductible.
409.83  Inpatient hospital coinsurance.
409.85  Skilled nursing facility (SNF) care coinsurance.
409.87  Blood deductible.
409.89  Exemption of kidney donors from deductible and coinsurance 
          requirements.

           Subpart H--Payments of Hospital Insurance Benefits

409.100  To whom payment is made.
409.102  Amounts of payment.

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

    Source: 48 FR 12541, Mar. 25, 1983, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 409 appear at 62 FR 
46037, Aug. 29, 1997.



       Subpart A--Hospital Insurance Benefits: General Provisions



Sec. 409.1  Statutory basis.

    This part is based on the identified provisions of the following 
sections of the Social Security Act:
    (a) Sections 1812 and 1813 establish the scope of benefits of the 
hospital insurance program under Medicare Part A and set forth 
deductible and coinsurance requirements.
    (b) Sections 1814 and 1815 establish conditions for, and limitations 
on, payment for services furnished by providers.
    (c) Section 1820 establishes the critical access hospital program.
    (d) Section 1861 describes the services covered under Medicare Part 
A, and benefit periods.
    (e) Section 1862(a) specifies exclusions from coverage; and section 
1862(h) requires a registry of pacemakers.
    (f) Section 1881 sets forth the rules for individuals who have end-
stage renal disease (ESRD), for organ donors, and for dialysis, 
transplantation, and other services furnished to ESRD patients.

[60 FR 50441, Sept. 29, 1995]



Sec. 409.2  Scope.

    Subparts A through G of this part describe the benefits available 
under Medicare Part A and set forth the limitations on those benefits, 
including certain amounts of payment for which beneficiaries are 
responsible.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985]



Sec. 409.3  Definitions.

    As used in this part, unless the context indicates otherwise--
    Arrangements means arrangements which provide that Medicare payment 
made to the provider that arranged for the services discharges the 
liability of the beneficiary or any other person to pay for those 
services.
    Covered refers to services for which the law and the regulations 
authorize Medicare payment.
    Nominal charge provider means a provider that furnishes services 
free of charge or at a nominal charge and is either a public provider, 
or another provider that (1) demonstrates to HCFA's satisfaction that a 
significant portion of its patients are low-income, and (2) requests 
that payment for its services be determined accordingly.
    Participating refers to a hospital or other facility that meets the 
conditions of participation and has in effect a Medicare provider 
agreement.
    Qualified hospital means a facility that--
    (a) Is primarily engaged in providing, by or under the supervision 
of doctors of medicine or osteopathy, inpatient services for the 
diagnosis, treatment, and care or rehabilitation of persons who are 
sick, injured, or disabled;
    (b) Is not primarily engaged in providing skilled nursing care and 
related services for inpatients who require medical or nursing care;
    (c) Provides 24-hour nursing service in accordance with Sec. 
1861(e)(5) of the Act;
    (d) If it is a U.S. hospital, is licensed, or approved as meeting 
the standards for licensing, by the State or local licensing agency; and
    (e) If it is a foreign hospital, is licensed, or approved as meeting 
the standard for licensing, by the appropriate Canadian or Mexican 
licensing agency, and for purposes of furnishing non-emergency services 
to U.S. residents, is accredited by the Joint Commission on 
Accreditation of Hospitals

[[Page 209]]

(JCAH), or by a Canadian or Mexican program under standards that HCFA 
finds to be equivalent to those of the JCAH.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
51 FR 41338, Nov. 14, 1986]



Sec. 409.5  General description of benefits.

    Hospital insurance (Part A of Medicare) helps pay for inpatient 
hospital or inpatient CAH services and posthospital SNF care. It also 
pays for home health services and hospice care. There are limitations on 
the number of days of care that Medicare can pay for and there are 
deductible and coinsurance amounts for which the beneficiary is 
responsible. For each type of service, certain conditions must be met as 
specified in the pertinent sections of this subpart and in part 418 of 
this chapter regarding hospice care. The special conditions for 
inpatient hospital services furnished by a qualified U.S., Canadian, or 
Mexican hospital are set forth in subparts G and H of part 424 of this 
chapter.

[48 FR 56026, Dec. 16, 1983, as amended at 53 FR 6648, Mar. 2, 1988; 53 
FR 12945, Apr. 20, 1988; 58 FR 30666, May 26, 1993]



  Subpart B--Inpatient Hospital Services and Inpatient Critical Access 
                            Hospital Services



Sec. 409.10  Included services.

    (a) Subject to the conditions, limitations, and exceptions set forth 
in this subpart, the term ``inpatient hospital or inpatient CAH 
services'' means the following services furnished to an inpatient of a 
participating hospital or of a participating CAH or, in the case of 
emergency services or services in foreign hospitals, to an inpatient of 
a qualified hospital:
    (1) Bed and board.
    (2) Nursing services and other related services.
    (3) Use of hospital or CAH facilities.
    (4) Medical social services.
    (5) Drugs, biologicals, supplies, appliances, and equipment.
    (6) Certain other diagnostic or therapeutic services.
    (7) Medical or surgical services provided by certain interns or 
residents-in-training.
    (8) Transportation services, including transport by ambulance.
    (b) Inpatient hospital services does not include the following types 
of services:
    (1) Posthospital SNF care, as described in Sec. 409.20, furnished by 
a hospital or a critical access hospital that has a swing-bed approval.
    (2) Nursing facility services, described in Sec. 440.155 of this 
chapter, that may be furnished as a Medicaid service under title XIX of 
the Act in a swing-bed hospital that has an approval to furnish nursing 
facility services.
    (3) Physician services that meet the requirements of Sec. 415.102(a) 
of this chapter for payment on a fee schedule basis.
    (4) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (5) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (6) Certified nurse mid-wife services, as defined in section 
1861(gg) of the Act.
    (7) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (8) Services of an anesthetist, as defined in Sec. 410.69

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30666, May 26, 1993; 64 FR 3648, Jan. 25, 1999; 65 FR 18535, Apr. 
7, 2000]



Sec. 409.11  Bed and board.

    (a) Semiprivate and ward accommodations. Except for applicable 
deductible and coinsurance amounts, Medicare Part A pays in full for bed 
and board and semiprivate (2 to 4 beds), or ward (5 or more beds) 
accommodations.
    (b) Private accommodations--(1) Conditions for payment in full. 
Except for applicable deductible and coinsurance amounts, Medicare Part 
A pays in full for a private room if--
    (i) The patient's condition requires him or her to be isolated;
    (ii) The hospital or CAH has no semiprivate or ward accommodations; 
or
    (iii) The hospital's or CAH's semiprivate and ward accommodations 
are fully occupied by other patients, were so occupied at the time the 
patient was

[[Page 210]]

admitted to the hospital or CAH, respectively, for treatment of a 
condition that required immediate inpatient hospital or inpatient CAH 
care, and have been so occupied during the interval.
    (2) Period of payment. In the situations specified in paragraph 
(b)(1) (i) and (iii) of this section, Medicare pays for a private room 
until the patient's condition no longer requires isolation or until 
semiprivate or ward accommodations are available.
    (3) Conditions for patient's liability. The hospital or CAH may 
charge the patient the difference between its customary charge for the 
private room and its most prevalent charge for a semiprivate room if--
    (i) None of the conditions of paragraph (b)(1) of this section is 
met; and
    (ii) The private room was requested by the patient or a member of 
the family, who, at the time of the request, was informed what the 
hospital's or CAH's charge would be.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.12  Nursing and related services, medical social services; use of hospital or CAH facilities.

    (a) Except as provided in paragraph (b) of this section, Medicare 
pays for nursing and related services, use of hospital or CAH 
facilities, and medical social services as inpatient hospital or 
inpatient CAH services only if those services are ordinarily furnished 
by the hospital or CAH, respectively, for the care and treatment of 
inpatients.
    (b) Exception. Medicare does not pay for the services of a private 
duty nurse or attendant. An individual is not considered to be a private 
duty nurse or attendant if he or she is a hospital or CAH employee at 
the time the services are furnished.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30666, 30667, May 26, 1993]



Sec. 409.13  Drugs and biologicals.

    (a) Except as specified in paragraph (b) of this section, Medicare 
pays for drugs and biologicals as inpatient hospital or inpatient CAH 
services only if--
    (1) They represent a cost to the hospital or CAH;
    (2) They are ordinarily furnished by the hospital or CAH for the 
care and treatment of inpatients; and
    (3) They are furnished to an inpatient for use in the hospital or 
CAH.
    (b) Exception. Medicare pays for a limited supply of drugs for use 
outside the hospital or CAH if it is medically necessary to facilitate 
the beneficiary's departure from the hospital and required until he or 
she can obtain a continuing supply.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.14  Supplies, appliances, and equipment.

    (a) Except as specified in paragraph (b) of this section, Medicare 
pays for supplies, appliances, and equipment as inpatient hospital or 
inpatient CAH services only if--
    (1) They are ordinarily furnished by the hospital or CAH to 
inpatients; and
    (2) They are furnished to inpatients for use in the hospital or CAH.
    (b) Exceptions. Medicare pays for items to be used beyond the 
hospital or CAH stay if--
    (1) The item is one that the beneficiary must continue to use after 
he or she leaves the hospital or CAH, for example, heart valves or a 
heart pacemaker, or
    (2) The item is medically necessary to permit or facilitate the 
beneficiary's departure from the hospital or CAH and is required until 
the beneficiary can obtain a continuing supply. Tracheostomy or draining 
tubes are examples.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.15  Services furnished by an intern or a resident-in-training.

    Medical or surgical services provided by an intern or a resident-in-
training are included as ``inpatient hospital or inpatient CAH 
services'' if they are provided--
    (a) By an intern or a resident-in-training under a teaching program 
approved by the Council on Medical Education of the American Medical 
Association, or the Bureau of Professional Education of the American 
Osteopathic Association;

[[Page 211]]

    (b) By an intern or a resident-in-training in the field of dentistry 
under a teaching program approved by the Council on Dental Education of 
the American Dental Association; or
    (c) By an intern or a resident-in-training in the field of podiatry 
under a teaching program approved by the Council on Podiatry Education 
of the American Podiatry Association.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.16  Other diagnostic or therapeutic services.

    Diagnostic or therapeutic services other than those provided for in 
Secs. 409.12, 409.13, and 409.14 are considered as inpatient hospital or 
inpatient CAH services if--
    (a) They are furnished by the hospital or CAH, or by others under 
arrangements made by the hospital or CAH;
    (b) Billing for those services is through the hospital or CAH; and
    (c) The services are of a kind ordinarily furnished to inpatients 
either by the hospital or CAH or under arrangements made by the hospital 
or CAH.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.18  Services related to kidney transplantations.

    (a) Kidney transplants. Medicare pays for kidney transplantation 
surgery only if performed in a renal transplantation center approved 
under subpart U of part 405 of this chapter.
    (b) Services in connection with kidney donations. Medicare pays for 
services related to the evaluation or preparation of a potential or 
actual donor, to the donation of the kidney, or to postoperative 
recovery services directly related to the kidney donation--
    (1) If the kidney is intended for an individual who has ESRD and is 
entitled to Medicare benefits or can be expected to become so entitled 
within a reasonable time; and
    (2) Regardless of whether the donor is entitled to Medicare.



Sec. 409.19  Services related to cardiac pacemakers and pacemaker leads.

    (a) Requirement. (1) Providers that request or receive Medicare 
payment for the implantation, removal, or replacement of permanent 
cardiac pacemakers and pacemaker leads must submit to HCFA the 
information required for the pacemaker registry.
    (2) The required information is set forth under 21 CFR part 805 of 
the FDA regulations and must be submitted in accordance with general 
instructions issued by HCFA.
    (b) Denial of payment. If HCFA finds that a provider has failed to 
comply with paragraph (a) of this section, HCFA denies payment for the 
implantation, removal, or replacement of any permanent cardiac pacemaker 
or pacemaker lead, effective 45 days after sending the provider written 
notice in accordance with paragraph (c) of this section.
    (c) Notice of denial of payment. The notice of denial of payment--
    (1) States the reasons for the determination;
    (2) Grants the provider 45 days from the date of the notice to 
submit the information or evidence showing that the determination is in 
error; and
    (3) Informs the provider of its right to hearing.
    (d) Right to hearing. If the denial of payment determination goes 
into effect at the expiration of the 45-day period, it constitutes an 
``initial determination'' subject to administrative and judicial review 
under part 498 of this chapter.

[56 FR 8840, Mar. 1, 1991; 56 FR 23022, May 20, 1991]



                    Subpart C--Posthospital SNF Care



Sec. 409.20  Coverage of services.

    (a) Included services. Subject to the conditions and limitations set 
forth in this subpart and subpart D of this part, ``posthospital SNF 
care'' means the following services furnished to an inpatient of a 
participating SNF, or of a participating hospital or critical access 
hospital (CAH) that has a swing-bed approval:
    (1) Nursing care provided by or under the supervision of a 
registered professional nurse.
    (2) Bed and board in connection with the furnishing of that nursing 
care.
    (3) Physical, occupational, or speech therapy.

[[Page 212]]

    (4) Medical social services.
    (5) Drugs, biologicals, supplies, appliances, and equipment.
    (6) Services furnished by a hospital with which the SNF has a 
transfer agreement in effect under Sec. 483.75(n) of this chapter.
    (7) Other services that are generally provided by (or under 
arrangements made by) SNFs.
    (b) Excluded services--(1) Services that are not considered 
inpatient hospital services. No service is included as posthospital SNF 
care if it would not be included as an inpatient hospital service under 
Secs. 409.11 through 409.18.
    (2) Services not generally provided by (or under arrangements made 
by) SNFs. Except as specifically listed in Secs. 409.21 through 409.27, 
only those services generally provided by (or under arrangements made 
by) SNFs are considered as posthospital SNF care. For example, a type of 
medical or surgical procedure that is ordinarily performed only on an 
inpatient basis in a hospital is not included as ``posthospital SNF 
care,'' because such procedures are not generally provided by (or under 
arrangements made by) SNFs.
    (c) Terminology. In Secs. 409.22 through 409.36--
    (1) The terms SNF and swing-bed hospital are used when the context 
applies to the particular facility.
    (2) The term facility is used to mean both SNFs and swing-bed 
hospitals.
    (3) The term ``swing-bed hospital'' includes a CAH with swing-bed 
approval under subpart F of part 485 of this chapter.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30667, May 26, 1993; 63 FR 26306, May 12, 1998; 64 FR 3648, Jan. 
25, 1999; 64 FR 41681, July 30, 1999]



Sec. 409.21  Nursing care.

    (a) Basic rule. Medicare pays for nursing care as posthospital SNF 
care when provided by or under the supervision of a registered 
professional nurse.
    (b) Exception. Medicare does not pay for the services of a private 
duty nurse or attendant. An individual is not considered to be a private 
duty nurse or attendant if he or she is an SNF employee at the time the 
services are furnished.

[63 FR 26306, May 12, 1998]



Sec. 409.22  Bed and board.

    (a) Semiprivate and ward accommodations. Except for applicable 
deductible and coinsurance amounts Medicare Part A pays in full for 
semiprivate (2 to 4 beds), or ward (5 or more beds) accommodations.
    (b) Private accommodations--(1) Conditions for payment in full. 
Except for applicable coinsurance amounts, Medicare pays in full for a 
private room if--
    (i) The patient's condition requires him to be isolated;
    (ii) The SNF has no semiprivate or ward accommodations; or
    (iii) The SNF semiprivate and ward accommodations are fully occupied 
by other patients, were so occupied at the time the patient was admitted 
to the SNF for treatment of a condition that required immediate 
inpatient SNF care, and have been so occupied during the interval.
    (2) Period of payment. In the situations specified in paragraph 
(b)(1) (i) and (iii) of this section. Medicare pays for a private room 
until the patient's condition no longer requires isolation or until 
semiprivate or ward accommodations are available.
    (3) Conditions for patient's liability. The facility may charge the 
patient the difference between its customary charge for the private room 
furnished and its most prevalent charge for a semiprivate room if:
    (i) None of the conditions of paragraph (b)(1) of this section is 
met, and
    (ii) The private room was requested by the patient or a member of 
the family who, at the time of request was informed what the charge 
would be.



Sec. 409.23  Physical, occupational, and speech therapy.

    Medicare pays for physical, occupational, or speech therapy as 
posthospital SNF care if--
    (a) It is furnished by the facility or under arrangements made by 
the facility, and
    (b) Billing for the therapy is by or through the facility.



Sec. 409.24  Medical social services.

    Medicare pays for medical social services as posthospital SNF care, 
including--

[[Page 213]]

    (a) Assessment of the social and emotional factors related to the 
beneficiary's illness, need for care, response to treatment, and 
adjustment to care in the facility;
    (b) Case work services to assist in resolving social or emotional 
problems that may have an adverse effect on the beneficiary's ability to 
respond to treatment; and
    (c) Assessment of the relationship of the beneficiary's medical and 
nursing requirements to his or her home situation, financial resources, 
and the community resources available upon discharge from facility care.

[63 FR 26306, May 12, 1998]



Sec. 409.25  Drugs, biologicals, supplies, appliances, and equipment.

    (a) Drugs and biologicals. Except as specified in paragraph (b) of 
this section, Medicare pays for drugs and biologicals as posthospital 
SNF care only if--
    (1) They represent a cost to the facility;
    (2) They are ordinarily furnished by the facility for the care and 
treatment of inpatients; and
    (3) They are furnished to an inpatient for use in the facility.
    (b) Exception. Medicare pays for a limited supply of drugs for use 
outside the facility if it is medically necessary to facilitate the 
beneficiary's departure from the facility and required until he or she 
can obtain a continuing supply.
    (c) Supplies, appliances, and equipment. Except as specified in 
paragraph (d) of this section, Medicare pays for supplies, appliances, 
and equipment as posthospital SNF care only if they are--
    (1) Ordinarily furnished by the facility to inpatients; and
    (2) Furnished to inpatients for use in the facility.
    (d) Exception. Medicare pays for items to be used after the 
individual leaves the facility if--
    (1) The item is one that the beneficiary must continue to use after 
leaving, such as a leg brace; or
    (2) The item is necessary to permit or facilitate the beneficiary's 
departure from the facility and is required until he or she can obtain a 
continuing supply, for example, sterile dressings.

[63 FR 26307, May 12, 1998]



Sec. 409.26  Transfer agreement hospital services.

    (a) Services furnished by an intern or a resident-in-training. 
Medicare pays for medical services that are furnished by an intern or a 
resident-in-training (under a hospital teaching program approved in 
accordance with the provisions of Sec. 409.15) as posthospital SNF care, 
if the intern or resident is in--
    (1) A participating hospital with which the SNF has in effect an 
agreement under Sec. 483.75(n) of this chapter for the transfer of 
patients and exchange of medical records; or
    (2) A hospital that has a swing-bed approval, and is furnishing 
services to an SNF-level inpatient of that hospital.
    (b) Other diagnostic or therapeutic services. Medicare pays for 
other diagnostic or therapeutic services as posthospital SNF care if 
they are provided--
    (1) By a participating hospital with which the SNF has in effect a 
transfer agreement as described in paragraph (a)(1) of this section; or
    (2) By a hospital or a CAH that has a swing-bed approval, to its own 
SNF-level inpatient.

[63 FR 26307, May 12, 1998]



Sec. 409.27  Other services generally provided by (or under arrangements made by) SNFs.

    In addition to those services specified in Secs. 409.21 through 
409.26, Medicare pays as posthospital SNF care for such other diagnostic 
and therapeutic services as are generally provided by (or under 
arrangements made by) SNFs, including--
    (a) Medical and other health services as described in subpart B of 
part 410 of this chapter, subject to any applicable limitations or 
exclusions contained in that subpart or in Sec. 409.20(b);
    (b) Respiratory therapy services prescribed by a physician for the 
assessment, diagnostic evaluation, treatment, management, and monitoring 
of patients with deficiencies and abnormalities of cardiopulmonary 
function; and

[[Page 214]]

    (c) Transportation by ambulance that meets the general medical 
necessity requirements set forth in Sec. 410.40(d)(1) of this chapter.

[63 FR 26307, May 12, 1998, as amended at 64 FR 41681, July 30, 1999]



      Subpart D--Requirements for Coverage of Posthospital SNF Care



Sec. 409.30  Basic requirements.

    Posthospital SNF care, including SNF-type care furnished in a 
hospital or CAH that has a swing-bed approval, is covered only if the 
beneficiary meets the requirements of this section and only for days 
when he or she needs and receives care of the level described in 
Sec. 409.31. A beneficiary in an SNF is also considered to meet the 
level of care requirements of Sec. 409.31 up to and including the 
assessment reference date for the 5-day assessment prescribed in 
Sec. 413.343(b) of this chapter, when assigned to one of the Resource 
Utilization Groups that is designated (in the annual publication of 
Federal prospective payment rates described in Sec. 413.345 of this 
chapter) as representing the required level of care. For the purposes of 
this section, the assessment reference date is defined in accordance 
with Sec. 483.315(d) of this chapter, and must occur no later than the 
eighth day of posthospital SNF care.
    (a) Pre-admission requirements. The beneficiary must--
    (1) Have been hospitalized in a participating or qualified hospital 
or participating CAH, for medically necessary inpatient hospital or 
inpatient CAH care, for at least 3 consecutive calendar days, not 
counting the date of discharge; and
    (2) Have been discharged from the hospital or CAH in or after the 
month he or she attained age 65, or in a month for which he or she was 
entitled to hospital or CAH insurance benefits on the basis of 
disability or end-stage renal disease, in accordance with part 406 of 
this chapter.
    (b) Date of admission requirements.1 (1) Except as 
specified in paragraph (b)(2) of this section, the beneficiary must be 
in need of posthospital SNF care, be admitted to the facility, and 
receive the needed care within 30 calendar days after the date of 
discharge from a hospital or CAH.
---------------------------------------------------------------------------

    1 Before December 5, 1980, the law required that 
admission and receipt of care be within 14 days after discharge from the 
hospital or CAH and permitted admission up to 28 days after discharge if 
a SNF bed was not available in the geographic area in which the patient 
lived, or at the time it would be medically appropriate to begin an 
active course of treatment, if SNF care would not be medically 
appropriate within 14 days after discharge.
---------------------------------------------------------------------------

    (2) Exception. A beneficiary for whom posthospital SNF care would 
not be medically appropriate within 30 days after discharge from the 
hospital or CAH may be admitted at the time it would be medically 
appropriate to begin an active course of treatment.

[48 FR 12541, Mar. 25, 1983, as amended at 51 FR 41338, Nov. 14, 1986; 
58 FR 30666, 30667, May 26, 1993; 62 FR 46025, Aug. 29, 1997; 63 FR 
26307, May 12, 1998; 64 FR 41681, July 30, 1999]



Sec. 409.31  Level of care requirement.

    (a) Definition. As used in this section, skilled nursing and skilled 
rehabilitation services means services that:
    (1) Are ordered by a physician;
    (2) Require the skills of technical or professional personnel such 
as registered nurses, licensed practical (vocational) nurses, physical 
therapists, occupational therapists, and speech pathologists or 
audiologists; and
    (3) Are furnished directly by, or under the supervision of, such 
personnel.
    (b) Specific conditions for meeting level of care requirements. (1) 
The beneficiary must require skilled nursing or skilled rehabilitation 
services, or both, on a daily basis.
    (2) Those services must be furnished for a condition--
    (i) For which the beneficiary received inpatient hospital or 
inpatient CAH services; or
    (ii) Which arose while the beneficiary was receiving care in a SNF 
or swing-bed hospital for a condition for which he or she received 
inpatient hospital or inpatient CAH services.
    (3) The daily skilled services must be ones that, as a practical 
matter, can

[[Page 215]]

only be provided in a SNF, on an inpatient basis.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.32  Criteria for skilled services and the need for skilled services.

    (a) To be considered a skilled service, the service must be so 
inherently complex that it can be safely and effectively performed only 
by, or under the supervision of, professional or technical personnel.
    (b) A condition that does not ordinarily require skilled services 
may require them because of special medical complications. Under those 
circumstances, a service that is usually nonskilled (such as those 
listed in Sec. 409.33(d)) may be considered skilled because it must be 
performed or supervised by skilled nursing or rehabilitation personnel. 
For example, a plaster cast on a leg does not usually require skilled 
care. However, if the patient has a preexisting acute skin condition or 
needs traction, skilled personnel may be needed to adjust traction or 
watch for complications. In situations of this type, the complications, 
and the skilled services they require, must be documented by physicians' 
orders and nursing or therapy notes.
    (c) The restoration potential of a patient is not the deciding 
factor in determining whether skilled services are needed. Even if full 
recovery or medical improvement is not possible, a patient may need 
skilled services to prevent further deterioration or preserve current 
capabilities. For example, a terminal cancer patient may need some of 
the skilled services described in Sec. 409.33.

[48 FR 12541, Mar. 25, 1983, as amended at 59 FR 65493, Dec. 20, 1994]



Sec. 409.33  Examples of skilled nursing and rehabilitation services.

    (a) Services that could qualify as either skilled nursing or skilled 
rehabilitation services--(1) Overall management and evaluation of care 
plan. (i) When overall management and evaluation of care plan constitute 
skilled services. The development, management, and evaluation of a 
patient care plan based on the physician's orders constitute skilled 
services when, because of the patient's physical or mental condition, 
those activities require the involvement of technical or professional 
personnel in order to meet the patient's needs, promote recovery, and 
ensure medical safety. Those activities include the management of a plan 
involving a variety of personal care services only when, in light of the 
patient's condition, the aggregate of those services requires the 
involvement of technical or professional personnel.
    (ii) Example. An aged patient with a history of diabetes mellitus 
and angina pectoris who is recovering from an open reduction of a 
fracture of the neck of the femur requires, among other services, 
careful skin care, appropriate oral medications, a diabetic diet, an 
exercise program to preserve muscle tone and body condition, and 
observation to detect signs of deterioration in his or her condition or 
complications resulting from restricted, but increasing, mobility. 
Although any of the required services could be performed by a properly 
instructed person, such a person would not have the ability to 
understand the relationship between the services and evaluate the 
ultimate effect of one service on the other. Since the nature of the 
patient's condition, age, and immobility create a high potential for 
serious complications, such an understanding is essential to ensure the 
patient's recovery and safety. Under these circumstances, the management 
of the plan of care would require the skills of a nurse even though the 
individual services are not skilled. Skilled planning and management 
activities are not always specifically identified in the patient's 
clinical record. Therefore, if the patient's overall condition supports 
a finding that recovery and safety can be ensured only if the total care 
is planned, managed, and evaluated by technical or professional 
personnel, it is appropriate to infer that skilled services are being 
provided.
    (2) Observation and assessment of the patient's changing condition--
(i) When observation and assessment constitute skilled services. 
Observation and assessment constitute skilled services when the skills 
of a technical or professional person are required to identify and

[[Page 216]]

evaluate the patient's need for modification of treatment or for 
additional medical procedures until his or her condition is stabilized.
    (ii) Examples. A patient with congestive heart failure may require 
continuous close observation to detect signs of decompensation, abnormal 
fluid balance, or adverse effects resulting from prescribed 
medication(s) that serve as indicators for adjusting therapeutic 
measures. Similarly, surgical patients transferred from a hospital to an 
SNF while in the complicated, unstabilized postoperative period, for 
example, after hip prosthesis or cataract surgery, may need continued 
close skilled monitoring for postoperative complications and adverse 
reaction. Patients who, in addition to their physical problems, exhibit 
acute psychological symptoms such as depression, anxiety, or agitation, 
may also require skilled observation and assessment by technical or 
professional personnel to ensure their safety or the safety of others, 
that is, to observe for indications of suicidal or hostile behavior. The 
need for services of this type must be documented by physicians' orders 
or nursing or therapy notes.
    (3) Patient education services--(i) When patient education services 
constitute skilled services. Patient education services are skilled 
services if the use of technical or professional personnel is necessary 
to teach a patient self-maintenance.
    (ii) Examples. A patient who has had a recent leg amputation needs 
skilled rehabilitation services provided by technical or professional 
personnel to provide gait training and to teach prosthesis care. 
Similarly, a patient newly diagnosed with diabetes requires instruction 
from technical or professional personnel to learn the self-
administration of insulin or foot-care precautions.
    (b) Services that qualify as skilled nursing services. (1) 
Intravenous or intramuscular injections and intravenous feeding.
    (2) Enteral feeding that comprises at least 26 per cent of daily 
calorie requirements and provides at least 501 milliliters of fluid per 
day.
    (3) Nasopharyngeal and tracheostomy aspiration;
    (4) Insertion and sterile irrigation and replacement of suprapubic 
catheters;
    (5) Application of dressings involving prescription medications and 
aseptic techniques;
    (6) Treatment of extensive decubitus ulcers or other widespread skin 
disorder;
    (7) Heat treatments which have been specifically ordered by a 
physician as part of active treatment and which require observation by 
nurses to adequately evaluate the patient's progress;
    (8) Initial phases of a regimen involving administration of medical 
gases;
    (9) Rehabilitation nursing procedures, including the related 
teaching and adaptive aspects of nursing, that are part of active 
treatment, e.g., the institution and supervision of bowel and bladder 
training programs.
    (c) Services which would qualify as skilled rehabilitation services. 
(1) Ongoing assessment of rehabilitation needs and potential: Services 
concurrent with the management of a patient care plan, including tests 
and measurements of range of motion, strength, balance, coordination, 
endurance, functional ability, activities of daily living, perceptual 
deficits, speech and language or hearing disorders;
    (2) Therapeutic exercises or activities: Therapeutic exercises or 
activities which, because of the type of exercises employed or the 
condition of the patient, must be performed by or under the supervision 
of a qualified physical therapist or occupational therapist to ensure 
the safety of the patient and the effectiveness of the treatment;
    (3) Gait evaluation and training: Gait evaluation and training 
furnished to restore function in a patient whose ability to walk has 
been impaired by neurological, muscular, or skeletal abnormality;
    (4) Range of motion exercises: Range of motion exercises which are 
part of the active treatment of a specific disease state which has 
resulted in a loss of, or restriction of, mobility (as evidenced by a 
therapist's notes showing the degree of motion lost and the degree to be 
restored);
    (5) Maintenance therapy; Maintenance therapy, when the specialized

[[Page 217]]

knowledge and judgment of a qualified therapist is required to design 
and establish a maintenance program based on an initial evaluation and 
periodic reassessment of the patient's needs, and consistent with the 
patient's capacity and tolerance. For example, a patient with 
Parkinson's disease who has not been under a rehabilitation regimen may 
require the services of a qualified therapist to determine what type of 
exercises will contribute the most to the maintenance of his present 
level of functioning.
    (6) Ultrasound, short-wave, and microwave therapy treatment by a 
qualified physical therapist;
    (7) Hot pack, hydrocollator, infrared treatments, paraffin baths, 
and whirlpool; Hot pack hydrocollator, infrared treatments, paraffin 
baths, and whirlpool in particular cases where the patient's condition 
is complicated by circulatory deficiency, areas of desensitization, open 
wounds, fractures, or other complications, and the skills, knowledge, 
and judgment of a qualified physical therapist are required; and
    (8) Services of a speech pathologist or audiologist when necessary 
for the restoration of function in speech or hearing.
    (d) Personal care services. Personal care services which do not 
require the skills of qualified technical or professional personnel are 
not skilled services except under the circumstances specified in 
Sec. 409.32(b). Personal care services include, but are not limited to, 
the following:
    (1) Administration of routine oral medications, eye drops, and 
ointments;
    (2) General maintenance care of colostomy and ileostomy;
    (3) Routine services to maintain satisfactory functioning of 
indwelling bladder catheters;
    (4) Changes of dressings for noninfected postoperative or chronic 
conditions;
    (5) Prophylactic and palliative skin care, including bathing and 
application of creams, or treatment of minor skin problems;
    (6) Routine care of the incontinent patient, including use of 
diapers and protective sheets;
    (7) General maintenance care in connection with a plaster cast;
    (8) Routine care in connection with braces and similar devices;
    (9) Use of heat as a palliative and comfort measure, such as 
whirlpool and hydrocollator;
    (10) Routine administration of medical gases after a regimen of 
therapy has been established;
    (11) Assistance in dressing, eating, and going to the toilet;
    (12) Periodic turning and positioning in bed; and
    (13) General supervision of exercises which have been taught to the 
patient; including the actual carrying out of maintenance programs, 
i.e., the performance of the repetitive exercises required to maintain 
function do not require the skills of a therapist and would not 
constitute skilled rehabilitation services (see paragraph (c) of this 
section). Similarly, repetitious exercises to improve gait, maintain 
strength, or endurance; passive exercises to maintain range of motion in 
paralyzed extremities, which are not related to a specific loss of 
function; and assistive walking do not constitute skilled rehabilitation 
services.

[48 FR 12541, Mar. 25, 1983, as amended at 63 FR 26307, May 12, 1998; 64 
FR 41681, July 30, 1999]



Sec. 409.34  Criteria for ``daily basis''.

    (a) To meet the daily basis requirement specified in 
Sec. 409.31(b)(1), the following frequency is required:
    (1) Skilled nursing services or skilled rehabilitation services must 
be needed and provided 7 days a week; or
    (2) As an exception, if skilled rehabilitation services are not 
available 7 days a week those services must be needed and provided at 
least 5 days a week.
    (b) A break of one or two days in the furnishing of rehabilitation 
services will not preclude coverage if discharge would not be practical 
for the one or two days during which, for instance, the physician has 
suspended the therapy sessions because the patient exhibited extreme 
fatigue.



Sec. 409.35  Criteria for ``practical matter''.

    (a) General considerations. In making a ``practical matter'' 
determination, as required by Sec. 409.31(b)(3), consideration

[[Page 218]]

must be given to the patient's condition and to the availability and 
feasibility of using more economical alternative facilities and 
services. However, in making that determination, the availability of 
Medicare payment for those services may not be a factor. Example: The 
beneficiary can obtain daily physical therapy from a physical therapist 
in independent practice. However, Medicare pays only the appropriate 
portion (after deduction of applicable deductible and coinsurance 
amounts) of the first $500 of services furnished by such a practitioner 
in a year. This limitation on payment may not be a basis for finding 
that the needed care can only be provided in a SNF.
    (b) Examples of circumstances that meet practical matter criteria. 
(1) Beneficiary's condition. Inpatient care would be required ``as a 
practical matter'' if transporting the beneficiary to and from the 
nearest facility that furnishes the required daily skilled services 
would be an excessive physical hardship.
    (2) Economy and efficiency. Even if the beneficiary's condition does 
not preclude transportation, inpatient care might be more efficient and 
less costly if, for instance, the only alternative is daily 
transportation by ambulance.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985]



Sec. 409.36  Effect of discharge from posthospital SNF care.

    If a beneficiary is discharged from a facility after receiving 
posthospital SNF care, he or she is not entitled to additional services 
of this kind in the same benefit period unless--
    (a) He or she is readmitted to the same or another facility within 
30 calendar days following the day of discharge (or, before December 5, 
1980, within 14 calendar days after discharge); or
    (b) He or she is again hospitalized for at least 3 consecutive 
calendar days.



        Subpart E--Home Health Services Under Hospital Insurance



Sec. 409.40  Basis, purpose, and scope.

    This subpart implements sections 1814(a)(2)(C), 1835(a)(2)(A), and 
1861(m) of the Act with respect to the requirements that must be met for 
Medicare payment to be made for home health services furnished to 
eligible beneficiaries.

[59 FR 65493, Dec. 20, 1994]



Sec. 409.41  Requirement for payment.

    In order for home health services to qualify for payment under the 
Medicare program the following requirements must be met:
    (a) The services must be furnished to an eligible beneficiary by, or 
under arrangements with, an HHA that--
    (1) Meets the conditions of participation for HHAs at part 484 of 
this chapter; and
    (2) Has in effect a Medicare provider agreement as described in part 
489, subparts A, B, C, D, and E of this chapter.
    (b) The physician certification and recertification requirements for 
home health services described in Sec. 424.22.
    (c) All requirements contained in Secs. 409.42 through 409.47.

[59 FR 65494, Dec. 20, 1994]



Sec. 409.42  Beneficiary qualifications for coverage of services.

    To qualify for Medicare coverage of home health services, a 
beneficiary must meet each of the following requirements:
    (a) Confined to the home. The beneficiary must be confined to the 
home or in an institution that is not a hospital, SNF or nursing 
facility as defined in section 1861(e)(1), 1819(a)(1) or 1919(a)(1) of 
the Act, respectively.
    (b) Under the care of a physician. The beneficiary must be under the 
care of a physician who establishes the plan of care. A doctor of 
podiatric medicine may establish a plan of care only if that is 
consistent with the functions he or she is authorized to perform under 
State law.
    (c) In need of skilled services. The beneficiary must need at least 
one of the following skilled services as certified by a physician in 
accordance with the physician certification and recertification 
requirements for home health services under Sec. 424.22 of this chapter.
    (1) Intermittent skilled nursing services that meet the criteria for 
skilled services and the need for skilled services found in Sec. 409.32. 
(Also see

[[Page 219]]

Sec. 409.33(a) and (b) for a description of examples of skilled nursing 
and rehabilitation services.)
    (2) Physical therapy services that meet the requirements of 
Sec. 409.44(c).
    (3) Speech-language pathology services that meet the requirements of 
Sec. 409.44(c).
    (4) Continuing occupational therapy services that meet the 
requirements of Sec. 409.44(c) if the beneficiary's eligibility for home 
health services has been established by virtue of a prior need for 
intermittent skilled nursing care, speech-language pathology services, 
or physical therapy in the current or prior certification period.
    (d) Under a plan of care. The beneficiary must be under a plan of 
care that meets the requirements for plans of care specified in 
Sec. 409.43.
    (e) By whom the services must be furnished. The home health services 
must be furnished by, or under arrangements made by, a participating 
HHA.

[59 FR 65494, Dec. 20, 1994; 60 FR 39122, Aug. 1, 1995]



Sec. 409.43  Plan of care requirements.

    (a) Contents. The plan of care must contain those items listed in 
Sec. 484.18(a) of this chapter that specify the standards relating to a 
plan of care that an HHA must meet in order to participate in the 
Medicare program.
    (b) Physician's orders. The physician's orders for services in the 
plan of care must specify the medical treatments to be furnished as well 
as the type of home health discipline that will furnish the ordered 
services and at what frequency the services will be furnished. Orders 
for services to be provided ``as needed'' or ``PRN'' must be accompanied 
by a description of the beneficiary's medical signs and symptoms that 
would occasion the visit and a specific limit on the number of those 
visits to be made under the order before an additional physician order 
would have to be obtained. Orders for care may indicate a specific range 
in frequency of visits to ensure that the most appropriate level of 
services is furnished. If a range of visits is ordered, the upper limit 
of the range is considered the specific frequency.
    (c) Physician signature. (1) Request for Anticipated payment 
signature requirements. If the physician signed plan of care is not 
available at the time the HHA requests an anticipated payment of the 
initial percentage prospective payment in accordance with Sec. 484.205, 
the request for the anticipated payment must be based on--
    (i) A physician's verbal order that--
    (A) Is recorded in the plan of care;
    (B) Includes a description of the patient's condition and the 
services to be provided by the home health agency;
    (C) Includes an attestation (relating to the physician's orders and 
the date received) signed and dated by the registered nurse or qualified 
therapist (as defined in 42 CFR 484.4) responsible for furnishing or 
supervising the ordered service in the plan of care; and
    (D) Is copied into the plan of care and the plan of care is 
immediately submitted to the physician; or
    (ii) A referral prescribing detailed orders for the services to be 
rendered that is signed and dated by a physician.
    (2) Reduction or disapproval of anticipated payment requests. HCFA 
has the authority to reduce or disapprove requests for anticipated 
payments in situations when protecting Medicare program integrity 
warrants this action. Since the request for anticipated payment is based 
on verbal orders as specified in paragraph (c)(1)(i) and/or a 
prescribing referral as specified in (c)(1)(ii) of this section 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 Civil Monetary 
Penalties Law (as defined in 42 U.S.C. 1320a-7a (i) (2)), the Civil 
False Claims Act (as defined in 31 U.S.C. 3729(c)), and the Criminal 
False Claims Act (18 U.S.C. 287)), the request for anticipated payment 
will be canceled and recovered unless the claim is submitted within the 
greater of 60 days from the end of the episode or 60 days from the 
issuance of the request for anticipated payment.
    (3) Final percentage payment signature requirements. The plan of 
care must be signed and dated--
    (i) By a physician as described who meets the certification and 
recertification requirements of Sec. 424.22 of this chapter; and

[[Page 220]]

    (ii) Before the claim for each episode for services is submitted for 
the final percentage prospective payment.
    (4) Changes to the plan of care signature requirements. Any changes 
in the plan must be signed and dated by a physician.
    (d) Oral (verbal) orders. If any services are provided based on a 
physician's oral orders, the orders must be put in writing and be signed 
and dated with the date of receipt by the registered nurse or qualified 
therapist (as defined in Sec. 484.4 of this chapter) responsible for 
furnishing or supervising the ordered services. Oral orders may only be 
accepted by personnel authorized to do so by applicable State and 
Federal laws and regulations as well as by the HHA's internal policies. 
The oral orders must also be countersigned and dated by the physician 
before the HHA bills for the care.
    (e) Frequency of review. (1) The plan of care must be reviewed by 
the physician (as specified in Sec. 409.42(b)) in consultation with 
agency professional personnel at least every 60 days or more frequently 
when there is a--
    (i) Beneficiary elected transfer;
    (ii) Significant change in condition resulting in a change in the 
case-mix assignment; or
    (iii) Discharge and return to the same HHA during the 60-day 
episode.
    (2) Each review of a beneficiary's plan of care must contain the 
signature of the physician who reviewed it and the date of review.
    (f) Termination of the plan of care. The plan of care is considered 
to be terminated if the beneficiary does not receive at least one 
covered skilled nursing, physical therapy, speech-language pathology 
services, or occupational therapy visit in a 60-day period unless the 
physician documents that the interval without such care is appropriate 
to the treatment of the beneficiary's illness or injury.

[59 FR 65494, Dec. 20, 1994, as amended at 65 FR 41210, July 3, 2000]



Sec. 409.44  Skilled services requirements.

    (a) General. The intermediary's decision on whether care is 
reasonable and necessary is based on information provided on the forms 
and in the medical record concerning the unique medical condition of the 
individual beneficiary. A coverage denial is not made solely on the 
basis of the reviewer's general inferences about patients with similar 
diagnoses or on data related to utilization generally but is based upon 
objective clinical evidence regarding the beneficiary's individual need 
for care.
    (b) Skilled nursing care. (1) Skilled nursing care consists of those 
services that must, under State law, be performed by a registered nurse, 
or practical (vocational) nurse, as defined in Sec. 484.4 of this 
chapter, and meet the criteria for skilled nursing services specified in 
Sec. 409.32. See Sec. 409.33(a) and (b) for a description of skilled 
nursing services and examples of them.
    (i) In determining whether a service requires the skill of a 
licensed nurse, consideration must be given to the inherent complexity 
of the service, the condition of the beneficiary, and accepted standards 
of medical and nursing practice.
    (ii) If the nature of a service is such that it can safely and 
effectively be performed by the average nonmedical person without direct 
supervision of a licensed nurse, the service cannot be regarded as a 
skilled nursing service.
    (iii) The fact that a skilled nursing service can be or is taught to 
the beneficiary or to the beneficiary's family or friends does not 
negate the skilled aspect of the service when performed by the nurse.
    (iv) If the service could be performed by the average nonmedical 
person, the absence of a competent person to perform it does not cause 
it to be a skilled nursing service.
    (2) The skilled nursing care must be provided on a part-time or 
intermittent basis.
    (3) The skilled nursing services must be reasonable and necessary 
for the treatment of the illness or injury.
    (i) To be considered reasonable and necessary, the services must be 
consistent with the nature and severity of the beneficiary's illness or 
injury, his or her particular medical needs, and accepted standards of 
medical and nursing practice.
    (ii) The skilled nursing care provided to the beneficiary must be 
reasonable within the context of the beneficiary's condition.

[[Page 221]]

    (iii) The determination of whether skilled nursing care is 
reasonable and necessary must be based solely upon the beneficiary's 
unique condition and individual needs, without regard to whether the 
illness or injury is acute, chronic, terminal, or expected to last a 
long time.
    (c) Physical therapy, speech-language pathology services, and 
occupational therapy. To be covered, physical therapy, speech-language 
pathology services, and occupational therapy must satisfy the criteria 
in paragraphs (c)(1) through (4) of this section. Occupational therapy 
services initially qualify for home health coverage only if they are 
part of a plan of care that also includes intermittent skilled nursing 
care, physical therapy, or speech-language pathology services as 
follows:
    (1) Speech-language pathology services and physical or occupational 
therapy services must relate directly and specifically to a treatment 
regimen (established by the physician, after any needed consultation 
with the qualified therapist) that is designed to treat the 
beneficiary's illness or injury. Services related to activities for the 
general physical welfare of beneficiaries (for example, exercises to 
promote overall fitness) do not constitute physical therapy, 
occupational therapy, or speech-language pathology services for Medicare 
purposes.
    (2) Physical and occupational therapy and speech-language pathology 
services must be reasonable and necessary. To be considered reasonable 
and necessary, the following conditions must be met:
    (i) The services must be considered under accepted standards of 
medical practice to be a specific, safe, and effective treatment for the 
beneficiary's condition.
    (ii) The services must be of such a level of complexity and 
sophistication or the condition of the beneficiary must be such that the 
services required can safely and effectively be performed only by a 
qualified physical therapist or by a qualified physical therapy 
assistant under the supervision of a qualified physical therapist, by a 
qualified speech-language pathologist, or by a qualified occupational 
therapist or a qualified occupational therapy assistant under the 
supervision of a qualified occupational therapist (as defined in 
Sec. 484.4 of this chapter). Services that do not require the 
performance or supervision of a physical therapist or an occupational 
therapist are not considered reasonable or necessary physical therapy or 
occupational therapy services, even if they are performed by or 
supervised by a physical therapist or occupational therapist. Services 
that do not require the skills of a speech-language pathologist are not 
considered to be reasonable and necessary speech-language pathology 
services even if they are performed by or supervised by a speech-
language pathologist.
    (iii) There must be an expectation that the beneficiary's condition 
will improve materially in a reasonable (and generally predictable) 
period of time based on the physician's assessment of the beneficiary's 
restoration potential and unique medical condition, or the services must 
be necessary to establish a safe and effective maintenance program 
required in connection with a specific disease, or the skills of a 
therapist must be necessary to perform a safe and effective maintenance 
program. If the services are for the establishment of a maintenance 
program, they may include the design of the program, the instruction of 
the beneficiary, family, or home health aides, and the necessary 
infrequent reevaluations of the beneficiary and the program to the 
degree that the specialized knowledge and judgment of a physical 
therapist, speech-language pathologist, or occupational therapist is 
required.
    (iv) The amount, frequency, and duration of the services must be 
reasonable.

[59 FR 65494, Dec. 20, 1994]



Sec. 409.45  Dependent services requirements.

    (a) General. Services discussed in paragraphs (b) through (g) of 
this section may be covered only if the beneficiary needs skilled 
nursing care on an intermittent basis, as described in Sec. 409.44(b); 
physical therapy or speech-language pathology services as described in 
Sec. 409.44(c); or has a continuing need for occupational therapy 
services as described in Sec. 409.44(c) if the

[[Page 222]]

beneficiary's eligibility for home health services has been established 
by virtue of a prior need for intermittent skilled nursing care, speech-
language pathology services, or physical therapy in the current or prior 
certification period; and otherwise meets the qualifying criteria 
(confined to the home, under the care of a physician, in need of skilled 
services, and under a plan of care) specified in Sec. 409.42. Home 
health coverage is not available for services furnished to a beneficiary 
who is no longer in need of one of the qualifying skilled services 
specified in this paragraph. Therefore, dependent services furnished 
after the final qualifying skilled service are not covered, except when 
the dependent service was not followed by a qualifying skilled service 
as a result of the unexpected inpatient admission or death of the 
beneficiary, or due to some other unanticipated event.
    (b) Home health aide services. To be covered, home health aide 
services must meet each of the following requirements:
    (1) The reason for the visits by the home health aide must be to 
provide hands-on personal care to the beneficiary or services that are 
needed to maintain the beneficiary's health or to facilitate treatment 
of the beneficiary's illness or injury. The physician's order must 
indicate the frequency of the home health aide services required by the 
beneficiary. These services may include but are not limited to:
    (i) Personal care services such as bathing, dressing, grooming, 
caring for hair, nail and oral hygiene that are needed to facilitate 
treatment or to prevent deterioration of the beneficiary's health, 
changing the bed linens of an incontinent beneficiary, shaving, 
deodorant application, skin care with lotions and/or powder, foot care, 
ear care, feeding, assistance with elimination (including enemas unless 
the skills of a licensed nurse are required due to the beneficiary's 
condition, routine catheter care, and routine colostomy care), 
assistance with ambulation, changing position in bed, and assistance 
with transfers.
    (ii) Simple dressing changes that do not require the skills of a 
licensed nurse.
    (iii) Assistance with medications that are ordinarily self-
administered and that do not require the skills of a licensed nurse to 
be provided safely and effectively.
    (iv) Assistance with activities that are directly supportive of 
skilled therapy services but do not require the skills of a therapist to 
be safely and effectively performed, such as routine maintenance 
exercises and repetitive practice of functional communication skills to 
support speech-language pathology services.
    (v) Routine care of prosthetic and orthotic devices.
    (2) The services to be provided by the home health aide must be--
    (i) Ordered by a physician in the plan of care; and
    (ii) Provided by the home health aide on a part-time or intermittent 
basis.
    (3) The services provided by the home health aide must be reasonable 
and necessary. To be considered reasonable and necessary, the services 
must--
    (i) Meet the requirement for home health aide services in paragraph 
(b)(1) of this section;
    (ii) Be of a type the beneficiary cannot perform for himself or 
herself; and
    (iii) Be of a type that there is no able or willing caregiver to 
provide, or, if there is a potential caregiver, the beneficiary is 
unwilling to use the services of that individual.
    (4) The home health aide also may perform services incidental to a 
visit that was for the provision of care as described in paragraphs 
(b)(3)(i) through (iii) of this section. For example, these incidental 
services may include changing bed linens, personal laundry, or preparing 
a light meal.
    (c) Medical social services. Medical social services may be covered 
if the following requirements are met:
    (1) The services are ordered by a physician and included in the plan 
of care.
    (2)(i) The services are necessary to resolve social or emotional 
problems that are expected to be an impediment to the effective 
treatment of the beneficiary's medical condition or to his or her rate 
of recovery.

[[Page 223]]

    (ii) If these services are furnished to a beneficiary's family 
member or caregiver, they are furnished on a short-term basis and it can 
be demonstrated that the service is necessary to resolve a clear and 
direct impediment to the effective treatment of the beneficiary's 
medical condition or to his or her rate of recovery.
    (3) The frequency and nature of the medical social services are 
reasonable and necessary to the treatment of the beneficiary's 
condition.
    (4) The medical social services are furnished by a qualified social 
worker or qualified social work assistant under the supervision of a 
social worker as defined in Sec. 484.4 of this chapter.
    (5) The services needed to resolve the problems that are impeding 
the beneficiary's recovery require the skills of a social worker or a 
social work assistant under the supervision of a social worker to be 
performed safely and effectively.
    (d) Occupational therapy. Occupational therapy services that are not 
qualifying services under Sec. 409.44(c) are nevertheless covered as 
dependent services if the requirements of Sec. 409.44(c)(2)(i) through 
(iv), as to reasonableness and necessity, are met.
    (e) Durable medical equipment. Durable medical equipment in 
accordance with Sec. 410.38 of this chapter, which describes the scope 
and conditions of payment for durable medical equipment under Part B, 
may be covered under the home health benefit as either a Part A or Part 
B service. Durable medical equipment furnished by an HHA as a home 
health service is always covered by Part A if the beneficiary is 
entitled to Part A.
    (f) Medical supplies. Medical supplies (including catheters, 
catheter supplies, ostomy bags, and supplies relating to ostomy care but 
excluding drugs and biologicals) may be covered as a home health 
benefit. For medical supplies to be covered as a Medicare home health 
benefit, the medical supplies must be needed to treat the beneficiary's 
illness or injury that occasioned the home health care.
    (g) Intern and resident services. The medical services of interns 
and residents in training under an approved hospital teaching program 
are covered if the services are ordered by the physician who is 
responsible for the plan of care and the HHA is affiliated with or under 
the common control of the hospital furnishing the medical services.

Approved means--
    (1) Approved by the Accreditation Council for Graduate Medical 
Education;
    (2) In the case of an osteopathic hospital, approved by the 
Committee on Hospitals of the Bureau of Professional Education of the 
American Osteopathic Association;
    (3) In the case of an intern or resident-in-training in the field of 
dentistry, approved by the Council on Dental Education of the American 
Dental Association; or
    (4) In the case of an intern or resident-in-training in the field of 
podiatry, approved by the Council on Podiatric Medical Education of the 
American Podiatric Medical Association.

[59 FR 65495, Dec. 20, 1994; 60 FR 39122, 39123, Aug. 1, 1995]



Sec. 409.46  Allowable administrative costs.

    Services that are allowable as administrative costs but are not 
separately billable include, but are not limited to, the following:
    (a) Registered nurse initial evaluation visits. Initial evaluation 
visits by a registered nurse for the purpose of assessing a 
beneficiary's health needs, determining if the agency can meet those 
health needs, and formulating a plan of care for the beneficiary are 
allowable administrative costs. If a physician specifically orders that 
a particular skilled service be furnished during the evaluation in which 
the agency accepts the beneficiary for treatment and all other coverage 
criteria are met, the visit is billable as a skilled nursing visit. 
Otherwise it is considered to be an administrative cost.
    (b) Visits by registered nurses or qualified professionals for the 
supervision of home health aides. Visits by registered nurses or 
qualified professionals for the purpose of supervising home health aides 
as required at Sec. 484.36(d) of this chapter are allowable 
administrative costs. Only if the registered nurse or

[[Page 224]]

qualified professional visits the beneficiary for the purpose of 
furnishing care that meets the coverage criteria at Sec. 409.44, and the 
supervisory visit occurs simultaneously with the provision of covered 
care, is the visit billable as a skilled nursing or therapist's visit.
    (c) Respiratory care services. If a respiratory therapist is used to 
furnish overall training or consultative advice to an HHA's staff and 
incidentally provides respiratory therapy services to beneficiaries in 
their homes, the costs of the respiratory therapist's services are 
allowable as administrative costs. Visits by a respiratory therapist to 
a beneficiary's home are not separately billable. However, respiratory 
therapy services that are furnished as part of a plan of care by a 
skilled nurse or physical therapist and that constitute skilled care may 
be separately billed as skilled visits.
    (d) Dietary and nutrition personnel. If dieticians or nutritionists 
are used to provide overall training or consultative advice to HHA staff 
and incidentally provide dietetic or nutritional services to 
beneficiaries in their homes, the costs of these professional services 
are allowable as administrative costs. Visits by a dietician or 
nutritionist to a beneficiary's home are not separately billable.

[59 FR 65496, Dec. 20, 1994]



Sec. 409.47  Place of service requirements.

    To be covered, home health services must be furnished in either the 
beneficiary's home or an outpatient setting as defined in this section.
    (a) Beneficiary's home. A beneficiary's home is any place in which a 
beneficiary resides that is not a hospital, SNF, or nursing facility as 
defined in sections 1861(e)(1), 1819(a)(1), of 1919(a)(1) of the Act, 
respectively.
    (b) Outpatient setting. For purposes of coverage of home health 
services, an outpatient setting may include a hospital, SNF or a 
rehabilitation center with which the HHA has an arrangement in 
accordance with the requirements of Sec. 484.14(h) of this chapter and 
that is used by the HHA to provide services that either--
    (1) Require equipment that cannot be made available at the 
beneficiary's home; or
    (2) Are furnished while the beneficiary is at the facility to 
receive services requiring equipment described in paragraph (b)(1) of 
this section.

[59 FR 65496, Dec. 20, 1994]



Sec. 409.48  Visits.

    (a) Number of allowable visits under Part A. To the extent that all 
coverage requirements specified in this subpart are met, payment may be 
made on behalf of eligible beneficiaries under Part A for an unlimited 
number of covered home health visits. All Medicare home health services 
are covered under hospital insurance unless there is no Part A 
entitlement.
    (b) Number of visits under Part B. To the extent that all coverage 
requirements specified in this subpart are met, payment may be made on 
behalf of eligible beneficiaries under Part B for an unlimited number of 
covered home health visits. Medicare home health services are covered 
under Part B only when the beneficiary is not entitled to coverage under 
Part A.
    (c) Definition of visit. A visit is an episode of personal contact 
with the beneficiary by staff of the HHA or others under arrangements 
with the HHA, for the purpose of providing a covered service.
    (1) Generally, one visit may be covered each time an HHA employee or 
someone providing home health services under arrangements enters the 
beneficiary's home and provides a covered service to a beneficiary who 
meets the criteria of Sec. 409.42 (confined to the home, under the care 
of a physician, in need of skilled services, and under a plan of care).
    (2) If the HHA furnishes services in an outpatient facility under 
arrangements with the facility, one visit may be covered for each type 
of service provided.
    (3) If two individuals are needed to provide a service, two visits 
may be covered. If two individuals are present, but only one is needed 
to provide the care, only one visit may be covered.
    (4) A visit is initiated with the delivery of covered home health 
services and ends at the conclusion of delivery of covered home health 
services. In those circumstances in which all reasonable and necessary 
home health

[[Page 225]]

services cannot be provided in the course of a single visit, HHA staff 
or others providing services under arrangements with the HHA may remain 
at the beneficiary's residence between visits (for example, to provide 
non-covered services). However, if all covered services could be 
provided in the course of one visit, only one visit may be covered.

[59 FR 65497, Dec. 20, 1994]



Sec. 409.49  Excluded services.

    (a) Drugs and biologicals. Drugs and biologicals are excluded from 
payment under the Medicare home health benefit.
    (1) A drug is any chemical compound that may be used on or 
administered to humans or animals as an aid in the diagnosis, treatment 
or prevention of disease or other condition or for the relief of pain or 
suffering or to control or improve any physiological pathologic 
condition.
    (2) A biological is any medicinal preparation made from living 
organisms and their products including, but not limited to, serums, 
vaccines, antigens, and antitoxins.
    (b) Transportation. The transportation of beneficiaries, whether to 
receive covered care or for other purposes, is excluded from home health 
coverage. Costs of transportation of equipment, materials, supplies, or 
staff may be allowable as administrative costs, but no separate payment 
is made for them.
    (c) Services that would not be covered as inpatient services. 
Services that would not be covered if furnished as inpatient hospital 
services are excluded from home health coverage.
    (d) Housekeeping services. Services whose sole purpose is to enable 
the beneficiary to continue residing in his or her home (for example, 
cooking, shopping, Meals on Wheels, cleaning, laundry) are excluded from 
home health coverage.
    (e) Services covered under the End Stage Renal Disease (ESRD) 
program. Services that are covered under the ESRD program and are 
contained in the composite rate reimbursement methodology, including any 
service furnished to a Medicare ESRD beneficiary that is directly 
related to that individual's dialysis, are excluded from coverage under 
the Medicare home health benefit.
    (f) Prosthetic devices. Items that meet the requirements of 
Sec. 410.36(a)(2) of this chapter for prosthetic devices covered under 
Part B are excluded from home health coverage. Catheters, catheter 
supplies, ostomy bags, and supplies relating to ostomy care are not 
considered prosthetic devices if furnished under a home health plan of 
care and are not subject to this exclusion from coverage.
    (g) Medical social services provided to family members. Except as 
provided in Sec. 409.45(c)(2), medical social services provided solely 
to members of the beneficiary's family and that are not incidental to 
covered medical social services being provided to the beneficiary are 
not covered.

[59 FR 65497, Dec. 20, 1994; 60 FR 39123, Aug. 1, 1995]



Sec. 409.50  Coinsurance for durable medical equipment (DME) furnished as a home health service.

    The coinsurance liability of the beneficiary or other person for DME 
furnished as a home health service is 20 percent of the customary 
(insofar as reasonable) charge for the services.

[51 FR 41339, Nov. 14, 1986. Redesignated at 59 FR 65496, Dec. 20, 1994]



             Subpart F--Scope of Hospital Insurance Benefits



Sec. 409.60  Benefit periods.

    (a) When benefit periods begin. The initial benefit period begins on 
the day the beneficiary receives inpatient hospital, inpatient CAH, or 
SNF services for the first time after becoming entitled to hospital 
insurance. Thereafter, a new benefit period begins whenever the 
beneficiary receives inpatient hospital, inpatient CAH, or SNF services 
after he or she has ended a benefit period as described in paragraph (b) 
of this section.
    (b) When benefit periods end--(1) A benefit period ends when a 
beneficiary has, for at least 60 consecutive days not been an inpatient 
in any of the following:

[[Page 226]]

    (i) A hospital that meets the requirements of section 1861(e)(1) of 
the Act.
    (ii) A CAH that meets the requirements of section 1820 of the Act.
    (iii) A SNF that meets the requirements of sections 1819(a)(1) or 
1861(y) of the Act.
    (2) For purposes of ending a benefit period, a beneficiary was an 
inpatient of a SNF if his or her care in the SNF met the skilled level 
of care requirements specified in Sec. 409.31(b) (1) and (3).
    (c) Presumptions. (1) For purposes of determining whether a 
beneficiary was an inpatient of a SNF under paragraph (b)(2) of this 
section--
    (i) A beneficiary's care met the skilled level of care requirements 
if inpatient SNF claims were paid for those services under Medicare or 
Medicaid, unless:
    (A) Such payments were made under Sec. 405.330 or Medicaid 
administratively necessary days provisions which result in payment for 
care not meeting the skilled level of care requirements, or
    (B) A Medicare denial and a Medicaid payment are made for the same 
period, in which case the presumption in paragraph (c)(2)(ii) of this 
section applies;
    (ii) A beneficiary's care met the skilled level of care requirements 
if a SNF claim was paid under section 1879(e) of the Social Security 
Act;
    (iii) A beneficiary's care did not meet the skilled level of care 
requirements if a SNF claim was paid for the services under 
Sec. 405.330;
    (iv) A beneficiary's care did not meet the skilled level of care 
requirements if a Medicaid SNF claim was denied on the grounds that the 
services were not at the skilled level of care (even if paid under 
applicable Medicaid administratively necessary days provisions which 
result in payment for care not meeting the skilled level of care 
requirements);
    (2) For purposes of determining whether a beneficiary was an 
inpatient of a SNF under paragraph (b)(2) of this section a 
beneficiary's care in a SNF is presumed--
    (i) To have met the skilled level of care requirements during any 
period for which the beneficiary was assigned to one of the Resource 
Utilization Groups designated as representing the required level of 
care, as provided in Sec. 409.30.
    (ii) To have met the skilled level of care requirements if a 
Medicaid or Medicare claim was denied on grounds other than that the 
services were not at the skilled level of care;
    (iii) Not to have met the skilled level of care requirements if a 
Medicare SNF claim was denied on the grounds that the services were not 
at the skilled level of care and payment was not made under 
Sec. 405.330; or
    (iv) Not to have met the skilled level of care requirements if no 
Medicare or Medicaid claim was submitted by the SNF.
    (3) If information upon which to base a presumption is not readily 
available, the intermediary may, at its discretion review the 
beneficiary's medical records to determine whether he or she was an 
inpatient of a SNF as set forth under paragraph (b)(2) of this section.
    (4) When the intermediary makes a benefit period determination based 
upon paragraph (c)(1) of this section, the beneficiary may seek to 
reverse the benefit period determination by timely appealing the prior 
Medicare SNF claim determination under part 405, subpart G of this 
chapter, or the prior Medicaid SNF claim under part 431, subpart E of 
this chapter.
    (5) When the intermediary makes a benefit period determination under 
paragraph (c)(2) of this section, the beneficiary will be notified of 
the basis for the determination, and of his or her right to present 
evidence to rebut the determination that the skilled level of care 
requirements specified in Sec. 409.31 (b)(1) and (b)(3) were or were not 
met on reconsideration and appeal under 42 CFR, part 405, subpart G of 
this chapter.
    (d) Limitation on benefit period determinations. When the 
intermediary considers the same prior SNF stay of a particular 
beneficiary in making benefit period determinations for more than one 
inpatient Medicare claim--
    (1) Medicare will recognize only the initial level of care 
characterization for that prior SNF stay (or if appealed under 42 CFR 
part 405, subpart G of this chapter, the level of care determined under 
appeal); or
    (2) If part of a prior SNF stay has one level of care 
characterization and another part has another level of care

[[Page 227]]

characterization, Medicare will recognize only the initial level of care 
characterization for a particular part of a prior SNF stay (or if 
appealed under 42 CFR part 405, subpart G of this chapter, the level of 
care determined under appeal).
    (e) Relation of benefit period to benefit limitations. The 
limitations specified in Secs. 409.61 and 409.64, and the deductible and 
coinsurance requirements set forth in subpart G of this part apply for 
each benefit period. The limitations of Sec. 409.63 apply only to the 
initial benefit period.

[52 FR 22645, June 15, 1987; 52 FR 28824, Aug. 4, 1987, as amended at 58 
FR 30667, May 26, 1993; 63 FR 26307, May 12, 1998]



Sec. 409.61  General limitations on amount of benefits.

    (a) Inpatient hospital or inpatient CAH services. (1) Regular 
benefit days. Up to 90 days are available in each benefit period, 
subject to the limitations on days for psychiatric hospital services set 
forth in Secs. 409.62 and 409.63.
    (i) For the first 60 days (referred to in this subpart as full 
benefit days), Medicare pays the hospital or CAH for all covered 
services furnished the beneficiary, except for a deductible which is the 
beneficiary's responsibility. (Section 409.82 specifies the requirements 
for the inpatient hospital deductible.)
    (ii) For the next 30 days (referred to in this subpart as 
coinsurance days), Medicare pays for all covered services except for a 
daily coinsurance amount, which is the beneficiary's responsibility. 
(Section 409.83 specifies the inpatient hospital coinsurance amounts.)
    (2) Lifetime reserve days. Each beneficiary has a non-renewable 
lifetime reserve of 60 days of inpatient hospital or inpatient CAH 
services that he may draw upon whenever he is hospitalized for more than 
90 days in a benefit period. Upon exhaustion of the regular benefit 
days, the reserve days will be used unless the beneficiary elects not to 
use them, as provided in Sec. 409.65. For lifetime reserve days, 
Medicare pays for all covered services except for a daily coinsurance 
amount that is the beneficiary's responsibility. (See Sec. 409.83.)
    (3) Order of payment for inpatient hospital or inpatient CAH 
services. Medicare pays for inpatient hospital services in the following 
order.
    (i) The 60 full benefit days;
    (ii) The 30 coinsurance days;
    (iii) The remaining lifetime reserve days.
    (b) Posthospital SNF care furnished by a SNF, or by a hospital or a 
CAH with a swing-bed approval. Up to 100 days are available in each 
benefit period after discharge from a hospital or CAH. For the first 20 
days, Medicare pays for all covered services. For the 21st through 100th 
day, Medicare pays for all covered services except for a daily 
coinsurance amount that is the beneficiary's responsibility.
    (c) Renewal of inpatient benefits. The beneficiary's full 
entitlement to the 90 inpatient hospital or inpatient CAH regular 
benefit days, and the 100 SNF benefit days, is renewed each time he or 
she begins a benefit period. However, once lifetime reserve days are 
used, they can never be renewed.
    (d) Home health services. Medicare Part A pays for all covered home 
health services1 with no deductible, and subject to the 
following limitations on payment for durable medical equipment (DME):
---------------------------------------------------------------------------

    \1\ Before July 1, 1981, Medicare Part A paid for not more than 100 
home health visits during one year following the beneficiary's most 
recent discharge from a hospital or a SNF.
---------------------------------------------------------------------------

    (1) For DME furnished by an HHA that is a nominal charge provider, 
Medicare Part A pays 80 percent of fair compensation.
    (2) For DME furnished by an HHA that is not a nominal charge 
provider, Medicare Part A pays the lesser of the following:
    (i) 80 percent of the reasonable cost of the service.
    (ii) The reasonable cost of, or the customary charge for, the 
service, whichever is less, minus 20 percent of the customary (insofar 
as reasonable) charge for the service.

[48 FR 12541, Mar. 25, 1983, as amended at 51 FR 41339, Nov. 14, 1986; 
54 FR 4027, Jan. 27, 1989; 58 FR 30666, 30667, May 26, 1993]



Sec. 409.62  Lifetime maximum on inpatient psychiatric care.

    There is a lifetime maximum of 190 days on inpatient psychiatric 
hospital

[[Page 228]]

services available to any beneficiary. Therefore, once an individual 
receives benefits for 190 days of care in a psychiatric hospital, no 
further benefits of that type are available to that individual.



Sec. 409.63  Reduction of inpatient psychiatric benefit days available in the initial benefit period.

    (a) Reduction rule. (1) If the individual was an inpatient in a 
psychiatric hospital on the first day of Medicare entitlement and for 
any of the 150 days immediately before that first day of entitlement, 
those days are subtracted from the 150 days (90 regular days plus 60 
lifetime reserve days) which would otherwise be available in the initial 
benefit period for inpatient psychiatric services in a psychiatric or 
general hospital.
    (2) Reduction is required only if the hospital was participating in 
Medicare as a psychiatric hospital on the individual's first day of 
entitlement.
    (3) The reduction applies only to the beneficiary's first benefit 
period. For subsequent benefit periods, the 90 benefit days, plus any 
remaining lifetime reserve days, subject to the 190 day lifetime limit 
on psychiatric hospital care, are available.
    (b) Application to general hospital days. (1) Days spent in a 
general hospital before entitlement are not subtracted under paragraph 
(a) of this section even if the stay was for diagnosis or treatment of 
mental illness.
    (2) After entitlement, all psychiatric care days, whether in a 
general or a psychiatric hospital, are counted toward the number of days 
available in the initial benefit period.
    (c) Examples: (1) The individual was an inpatient of a participating 
psychiatric hospital for 20 days before the first day of entitlement and 
remained there for another 6 months. Therefore, 130 days of benefits 
(150 minus 20) are payable. Payment could be made for: 60 full benefit 
days, 30 coinsurance days, and 40 lifetime reserve days.
    (2) During the 150-day period preceding Medicare entitlement, an 
individual had been a patient of a general hospital for 60 days of 
inpatient psychiatric care and had spent 90 days in a psychiatric 
hospital, ending with the first day of entitlement. During the initial 
benefit period, the beneficiary spent 90 days in a general hospital and 
received psychiatric care there. The 60 days spent in the general 
hospital for psychiatric treatment before entitlement do not reduce the 
benefits available in the first benefit period. Only the 90 days spent 
in the psychiatric hospital before entitlement reduce such benefits, 
leaving a total of 60 available psychiatric days. However, after 
entitlement, the reduction applies not only to days spent in a 
psychiatric hospital, but also to days of psychiatric treatment in a 
general hospital. Thus, Medicare payment could be made only for 60 of 
the 90 days spent in the general hospital.
    (3) An individual was admitted to a general hospital for a mental 
condition and, after 10 days, transferred to a participating psychiatric 
hospital. The individual remained in the psychiatric hospital for 78 
days before becoming entitled to hospital insurance benefits and for 130 
days after entitlement. The beneficiary was then transferred to a 
general hospital and received treatment of a medical condition for 20 
days. The 10 days spent in the general hospital during the 150-day pre-
entitlement period have no effect on the inpatient hospital benefit days 
available to the individual for psychiatric care in the first benefit 
period, even though the general hospital stay was for a mental 
condition. Only the 78 days spent in the psychiatric hospital during the 
pre-entitlement period are subtracted from the 150 benefit days. 
Accordingly, the individual has 72 days of psychiatric care (150 days 
less 78 days) available in the first benefit period. Benefits could be 
paid for the individual's hospitalization during the first benefit 
period in the following manner. For the 130-day psychiatric hospital 
stay, 72 days (60 full benefit days and 12 coinsurance days), and for 
the general hospital stay, 20 days (18 coinsurance and 2 lifetime 
reserve days).



Sec. 409.64  Services that are counted toward allowable amounts.

    (a) Except as provided in paragraph (b) of this section for lifetime 
reserve days, all covered inpatient days and home health visits are 
counted toward

[[Page 229]]

the allowable amounts specified in Secs. 409.61 through 409.63 if--
    (1) They are paid for by Medicare; or
    (2) They would be paid for by Medicare if the following requirements 
had been met:
    (i) A proper and timely request for payment had been filed; and
    (ii) The hospital, CAH, SNF, or home health agency had submitted all 
necessary evidence, including physician certification of need for 
services when such certification was required; or
    (3) They could not be paid for because the total payment due was 
equal to, or less than, the applicable deductible and coinsurance 
amounts.
    (b) Exception. Even though the requirements of paragraph (a)(2) of 
this section are met, lifetime reserve days are not counted toward the 
allowable amounts if the beneficiary elected or is deemed to have 
elected not to use them as set forth in Sec. 409.65.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30667, May 26, 1993]



Sec. 409.65  Lifetime reserve days.

    (a) Election not to use lifetime reserve days. (1) Whenever a 
beneficiary has exhausted the 90 regular benefit days, the hospital or 
CAH may bill Medicare for lifetime reserve days unless the beneficiary 
elects not to use them or, in accordance with paragraph (b) of this 
section, is deemed to have elected not to use them.
    (2) It may be advantageous to elect not to use lifetime reserve days 
if the beneficiary has private insurance coverage that begins after the 
first 90 inpatient days in a benefit period, or if the daily charge is 
only slightly higher than the lifetime reserve days coinsurance amount. 
In such cases, the beneficiary may want to save the lifetime reserve 
days for future care that may be more expensive.
    (3) If the beneficiary elects not to use lifetime reserve days for a 
particular hospital or CAH stay, they are still available for a later 
stay. However, once the beneficiary uses lifetime reserve days, they can 
never be renewed.
    (4) If the beneficiary elects not to use lifetime reserve days, the 
hospital or CAH may require him or her to pay for any services furnished 
after the regular days are exhausted.
    (b) Deemed election. A beneficiary will be deemed to have elected 
not to use lifetime reserve days if the average daily charges for such 
days is equal to or less than the applicable coinsurance amount 
specified in Sec. 409.83. A beneficiary would get no benefit from using 
the days under those circumstances.
    (c) Who may file an election. An election not to use reserve days 
may be filed by--
    (1) The beneficiary; or
    (2) If the beneficiary is physically or mentally unable to act, by 
the beneficiary's legal representative. In addition, if some other 
payment source is available, such as private insurance, any person 
authorized under Sec. 405.1664 of this chapter to execute a request for 
payment for the beneficiary may file the election.
    (d) Filing the election. (1) The beneficiary's election not to use 
lifetime reserve days must be filed in writing with the hospital or CAH.
    (2) The election may be filed at the time of admission to the 
hospital or CAH or at any time thereafter up to 90 days after the 
beneficiary's discharge.
    (3) A retroactive election (that is, one made after lifetime reserve 
days have been used because the regular days were exhausted), is not 
acceptable unless it is approved by the hospital or CAH.
    (e) Period covered by election--(1) General rule. Except as provided 
in paragraph (e)(2) of this section, an election not to use lifetime 
reserve days may apply to an entire hospital or CAH stay or to a single 
period of consecutive days in a stay, but cannot apply to selected days 
in a stay. For example, a beneficiary may restrict the election to the 
period covered by private insurance but cannot use individual lifetime 
reserve days within that period. If an election not to use reserve days 
is effective after the first day on which reserve days are available, it 
must remain in effect until the end of the stay, unless it is revoked in 
accordance with Sec. 409.66.
    (2) Exception. A beneficiary election not to use lifetime reserve 
days for an inpatient hospital or inpatient CAH stay for which payment 
may be made under the prospective payment system

[[Page 230]]

(part 412 of this chapter) is subject to the following rules:
    (i) If the beneficiary has one or more regular benefit days (see 
Sec. 409.61(a)(1) of this chapter) remaining in the benefit period upon 
entering the hospital or CAH, an election not to use lifetime reserve 
days will apply automatically to all days that are not outlier days. The 
beneficiary may also elect not to use lifetime reserve days for outlier 
days but this election must apply to all outlier days.
    (ii) If the beneficiary has no regular benefit days (see 
Sec. 409.61(a)(1) of this chapter) remaining in the benefit period upon 
entering the hospital or CAH, an election not to use lifetime reserve 
days must apply to the entire hospital or CAH stay.

[48 FR 12541, Mar. 25, 1983, as amended at 48 FR 39837, Sept. 1, 1983; 
49 FR 323, Jan. 3, 1984; 58 FR 30666, 30667, May 26, 1993]



Sec. 409.66  Revocation of election not to use lifetime reserve days.

    (a) Except as provided in paragraph (c) of this section, a 
beneficiary (or anyone authorized to execute a request for payment, if 
the beneficiary is incapacitated) may revoke an election not to use 
lifetime reserve days during hospitalization or within 90 days after 
discharge.
    (b) The revocation must be submitted to the hospital or CAH in 
writing and identify the stay or stays to which it applies.
    (c) Exceptions. A revocation of an election not to use lifetime 
reserve days may not be filed--
    (1) After the beneficiary dies; or
    (2) After the hospital or CAH has filed a claim under the 
supplementary medical insurance program (Medicare Part B), for medical 
and other health services furnished to the beneficiary on the days in 
question.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.68  Guarantee of payment for inpatient hospital or inpatient CAH services furnished before notification of exhaustion of benefits.

    (a) Conditions for payment. Payment may be made for inpatient 
hospital or inpatient CAH services furnished a beneficiary after he or 
she has exhausted the available benefit days if the following conditions 
are met:
    (1) The services were furnished before HCFA or the intermediary 
notified the hospital or CAH that the beneficiary had exhausted the 
available benefit days and was not entitled to have payment made for 
those services.
    (2) At the time the hospital or CAH furnished the services, it was 
unaware that the beneficiary had exhausted the available benefit days 
and could reasonably have assumed that he or she was entitled to have 
payment made for these services.
    (3) Payment would be precluded solely because the beneficiary has no 
benefit days available for the particular hospital or CAH stay.
    (4) The hospital or CAH claims reimbursement for the services and 
refunds any payments made for those services by the beneficiary or by 
another person on his or her behalf.
    (b) Limitations on payment. (1) If all of the conditions in 
paragraph (a) of this section are met, Medicare payment may be made for 
the day of admission, and up to 6 weekdays thereafter, plus any 
intervening Saturdays, Sundays, and Federal holidays.
    (2) Payment may not be made under this section for any day after the 
hospital or CAH is notified that the beneficiary has exhausted the 
available benefit days.
    (c) Recovery from the beneficiary. Any payment made to a hospital or 
CAH under this section is considered an overpayment to the beneficiary 
and may be recovered from him or her under the provisions set forth 
elsewhere in this chapter.

[48 FR 12541, Mar. 25, 1983, as amended at 50 FR 33033, Aug. 16, 1985; 
58 FR 30666, May 26, 1993]



        Subpart G--Hospital Insurance Deductibles and Coinsurance



Sec. 409.80  Inpatient deductible and coinsurance: General provisions.

    (a) What they are. (1) The inpatient deductible and coinsurance 
amounts are portions of the cost of covered hospital or CAH or SNF 
services that Medicare does not pay.

[[Page 231]]

    (2) The hospital or CAH or SNF may charge these amounts to the 
beneficiary or someone on his or her behalf.
    (b) Changes in the inpatient deductible and coinsurance amounts. (1) 
The law requires the Secretary to adjust the inpatient hospital 
deductible each year to reflect changes in the average cost of hospital 
care. In adjusting the deductible, the Secretary must use a formula 
specified in section 1813(b)(2) of the Act. Under that formula, the 
inpatient hospital deductible is increased each year by about the same 
percentage as the increase in the average Medicare daily hospital costs. 
The result of the deductible increase is that the beneficiary continues 
to pay about the same proportion of the hospital bill.
    (2) Since the coinsurance amounts are, by statute, specific 
fractions of the deductible, they change when the deductible changes.

[48 FR 12541, Mar. 25, 1983, as amended at 58 FR 30666, May 26, 1993]



Sec. 409.82  Inpatient hospital deductible.

    (a) General provisions--(1) The inpatient hospital deductible is a 
fixed amount chargeable to the beneficiary when he or she receives 
covered services in a hospital or a CAH for the first time in a benefit 
period.
    (2) Although the beneficiary may be hospitalized several times 
during a benefit period, the deductible is charged only once during that 
period. If the beneficiary begins more than one benefit period in the 
same year, a deductible is charged for each of those periods.
    (3) For services furnished before January 1, 1982, the applicable 
deductible is the one in effect when the benefit period began.
    (4) For services furnished after December 31, 1981, the applicable 
deductible is the one in effect during the calendar year in which the 
services were furnished.
    (b) Specific deductible amounts. The specific deductible amounts for 
each calendar year are published in the Federal Register no later than 
October 1 of the preceding year.
    (c) Exception to published amounts. If the total hospital or CAH 
charge is less than the deductible amount applicable for the calendar 
year in which the services were furnished, the amount of the charge is 
the deductible for the year.

[48 FR 12541, Mar. 25, 1983, as amended at 54 FR 4026, Jan. 27, 1989; 58 
FR 30666, 30667, May 26, 1993]



Sec. 409.83  Inpatient hospital coinsurance.

    (a) General provisions--(1) Inpatient hospital coinsurance is the 
amount chargeable to a beneficiary for each day after the first 60 days 
of inpatient hospital care or inpatient CAH care or both in a benefit 
period.
    (2) For each day from the 61st to the 90th day, the coinsurance 
amount is \1/4\ of the applicable deductible.
    (3) For each day from the 91st to the 150th day (lifetime reserve 
days), the coinsurance amount is \1/2\ of the applicable deductible.
    (4) For coinsurance days before January 1, 1982, the coinsurance 
amount is based on the deductible applicable for the calendar year in 
which the benefit period began. The coinsurance amounts do not change 
during a beneficiary's benefit period even though the coinsurance days 
may fall in a subsequent year for which a higher deductible amount has 
been determined.
    (5) For coinsurance days after December 31, 1981, the coinsurance 
amount is based on the deductible applicable for the calendar year in 
which the services were furnished. For example, if an individual starts 
a benefit period by being admitted to a hospital in 1981 and remains in 
the hospital long enough to use coinsurance days in 1982, the 
coinsurance amount charged for those days is based on the 1982 inpatient 
hospital deductible.
    (b) Specific coinsurance amounts. The specific coinsurance amounts 
for each calendar year are published in the Federal Register no later 
than October 1 of the preceding year.
    (c) Exceptions to published amounts. (1) If the actual charge to the 
patient for the 61st through the 90th day of inpatient hospital or 
inpatient CAH services is less than the coinsurance amount applicable 
for the calendar year in which the services were furnished, the actual 
charge per day is the daily coinsurance amount.

[[Page 232]]

    (2) If the actual charge to the patient for the 91st through the 
150th day (lifetime reserve days) is less than the coinsurance amount 
applicable for the calendar year in which the services were furnished, 
the beneficiary is deemed to have elected not to use the days because he 
or she would not benefit from using them.

[48 FR 12541, Mar. 25, 1983, as amended at 54 FR 4026, Jan. 27, 1989; 58 
FR 30666, 30667, May 26, 1993]



Sec. 409.85  Skilled nursing facility (SNF) care coinsurance.

    (a) General provisions. (1) SNF care coinsurance is the amount 
chargeable to a beneficiary after the first 20 days of SNF care in a 
benefit period.
    (2) For each day from the 21st through the 100th day, the 
coinsurance is \1/8\ of the applicable inpatient hospital deductible.
    (3) For coinsurance days before January 1, 1982, the coinsurance 
amount is based on the deductible applicable for the year in which the 
benefit period began. The coinsurance amounts do not change during a 
beneficiary's benefit period even though the coinsurance days may fall 
in a subsequent year for which a higher deductible amount has been 
determined.
    (4) For coinsurance days after December 31, 1981, the coinsurance 
amount is based on the deductible applicable for the calendar year in 
which the services were furnished.
    (b) Specific coinsurance amounts. The specific SNF coinsurance 
amounts for each calendar year are published in the Federal Register no 
later than October 1 of the preceding year.
    (c) Exception to published amounts. If the actual charge to the 
patient is less than the coinsurance amount applicable for the calendar 
year in which the services were furnished, the actual charge per day is 
the daily coinsurance.

[48 FR 12541, Mar. 25, 1983, as amended at 54 FR 4026, Jan. 27, 1989]



Sec. 409.87  Blood deductible.

    (a) General provisions. (1) As used in this section, packed red 
cells means the red blood cells that remain after plasma is separated 
from whole blood.
    (2) A unit of packed red cells is treated as the equivalent of a 
unit of whole blood.
    (3) Medicare does not pay for the first 3 units of whole blood or 
units of packed red cells that a beneficiary receives, during a calendar 
year, as an inpatient of a hospital or CAH or SNF, or on an outpatient 
basis under Medicare Part B.
    (4) The deductible does not apply to other blood components such as 
platelets, fibrinogen, plasma, gamma globulin, and serum albumin, or to 
the cost of processing, storing, and administering blood.
    (5) The blood deductible is in addition to the inpatient hospital 
deductible and daily coinsurance.
    (6) The Part A blood deductible is reduced to the extent that the 
Part B blood deductible has been applied. For example, if a beneficiary 
had received one unit under Medicare Part B, and later in the same 
benefit period received three units under Medicare Part A, Medicare Part 
A would pay for the third of the latter units. (As specified in 
Sec. 410.161 of this chapter, the Part B blood deductible is reduced to 
the extent a blood deductible has been applied under Medicare Part A.)
    (b) Beneficiary's responsibility for the first 3 units of whole 
blood or packed red cells. (1) Basic rule. Except as specified in 
paragraph (b)(2) of this section, the beneficiary is responsible for the 
first 3 units of whole blood or packed red cells. He or she has the 
option of paying the hospital's or CAH's charges for the blood or packed 
red cells or arranging for it to be replaced.
    (2) Exception. The beneficiary is not responsible for the first 3 
units of whole blood or packed red cells if the provider obtained that 
blood or red cells at no charge other than a processing or service 
charge. In that case, the blood or red cells is deemed to have been 
replaced.
    (c) Provider's right to charge for the first 3 units of whole blood 
or packed red cells--(1) Basic rule. Except as specified in paragraph 
(c)(2) of this section, a provider may charge a beneficiary its 
customary charge for any of the first 3 units of whole blood or packed 
red cells.

[[Page 233]]

    (2) Exception. A provider may not charge the beneficiary for the 
first 3 units of whole blood or packed red cells in any of the following 
circumstances:
    (i) The blood or packed red cells has been replaced.
    (ii) The provider (or its blood supplier) receives, from an 
individual or a blood bank, a replacement offer that meets the criteria 
specified in paragraph (d) of this section. The provider is precluded 
from charging even if it or its blood supplier rejects the replacement 
offer.
    (iii) The provider obtained the blood or packed red cells at no 
charge other than a processing or service charge and it is therefore 
deemed to have been replaced.
    (d) Criteria for replacement of blood. A blood replacement offer 
made by a beneficiary, or an individual or a blood bank on behalf of a 
beneficiary, discharges the beneficiary's obligation to pay for 
deductible blood or packed red cells if the replacement blood meets the 
applicable criteria specified in Food and Drug Administration 
regulations under 21 CFR part 640, i.e.--
    (1) The replacement blood would not endanger the health of a 
recipient; and
    (2) The prospective donor's health would not be endangered by making 
a blood donation.

[48 FR 12541, Mar. 25, 1983, as amended at 56 FR 8840, Mar. 1, 1991; 57 
FR 36014, Aug. 12, 1992; 58 FR 30666, 30667, May 26, 1993]



Sec. 409.89  Exemption of kidney donors from deductible and coinsurance requirements.

    The deductible and coinsurance requirements set forth in this 
subpart do not apply to any services furnished to an individual in 
connection with the donation of a kidney for transplant surgery.



            Subpart H--Payment of Hospital Insurance Benefits

    Source: 53 FR 6633, Mar. 2, 1988, unless otherwise noted.



Sec. 409.100  To whom payment is made.

    (a) Basic rule. Except as provided in paragraph (b) of this 
section--
    (1) Medicare pays hospital insurance benefits only to a 
participating provider.
    (2) For home health services (including medical supplies described 
in section 1861(m)(5) of the Act, but excluding durable medical 
equipment to the extent provided for in such section) furnished to an 
individual who at the time the item or service is furnished is under a 
plan of care of an HHA, payment is made to the HHA (without regard to 
whether the item or service is furnished by the HHA directly, under 
arrangement with the HHA, or under any other contracting or consulting 
arrangement).
    (b) Exceptions. Medicare may pay hospital insurance benefits as 
follows:
    (1) For emergency services furnished by a nonparticipating hospital, 
to the hospital or to the beneficiary, under the conditions prescribed 
in subpart G of part 424 of this chapter.
    (2) For services furnished by a Canadian or Mexican hospital, to the 
hospital or to the beneficiary, under the conditions prescribed in 
subpart H of part 424 of this chapter.

[53 FR 6633, Mar. 2, 1988, as amended at 65 FR 41211, July 3, 2000]



Sec. 409.102  Amounts of payment.

    (a) The amounts Medicare pays for hospital insurance benefits are 
generally determined in accordance with part 412 or part 413 of this 
chapter.
    (b) Except as provided in Secs. 409.61(d) and 409.89, hospital 
insurance benefits are subject to the deductible and coinsurance 
requirements set forth in subpart G of this part.



PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of Contents




                      Subpart A--General Provisions

Sec.
410.1  Basis and scope.
410.2  Definitions.
410.3  Scope of benefits.
410.5  Other applicable rules.

              Subpart B--Medical and Other Health Services

410.10  Medical and other health services: Included services.

[[Page 234]]

410.12  Medical and other health services: Basic conditions and 
          limitations.
410.14  Special requirements for services furnished outside the United 
          States.
410.20  Physicians' services.
410.22  Limitations on services of a chiropractor.
410.23  Limitations on services of an optometrist.
410.24  Limitations on services of a doctor of dental surgery or dental 
          medicine.
410.25  Limitations on services of a podiatrist.
410.26  Services and supplies incident to a physician's professional 
          services: Conditions.
410.27  Outpatient hospital services and supplies incident to a 
          physician service: Conditions.
410.28  Hospital or CAH diagnostic services furnished to outpatients: 
          Conditions.
410.29  Limitations on drugs and biologicals.
410.30  Prescription drugs used in immunosuppressive therapy.
410.31  Bone mass measurement: Conditions for coverage and frequency 
          standards.
410.32  Diagnostic X-ray tests, diagnostic laboratory tests, and other 
          diagnostic tests: Conditions.
410.33  Independent diagnostic testing facility.
410.34  Mammography services: Conditions for and limitations on 
          coverage.
410.35  X-ray therapy and other radiation therapy services: Scope.
410.36  Medical supplies, appliances, and devices: Scope.
410.37  Colorectal cancer screening tests: Conditions for and 
          limitations on coverage.
410.38  Durable medical equipment: Scope and conditions.
410.39  Prostate cancer screening tests: Conditions for and limitations 
          on coverage.
410.40  Coverage of ambulance services.
410.41  Requirements for ambulance suppliers.
410.42  Limitations on coverage of certain services furnished to 
          hospital outpatients.
410.43  Partial hospitalization services: Conditions and exclusions.
410.45  Rural health clinic services: Scope and conditions.
410.50  Institutional dialysis services and supplies: Scope and 
          conditions.
410.52  Home dialysis services, supplies, and equipment: Scope and 
          conditions.
410.55  Services related to kidney donations: Conditions.
410.56  Screening pelvic examinations.
410.57  Pneumococcal vaccine and flu vaccine.
410.58  Additional services to HMO and CMP enrollees.
410.59  Outpatient occupational therapy services: Conditions.
410.60  Outpatient physical therapy services: Conditions.
410.61  Plan of treatment requirements for outpatient rehabilitation 
          services.
410.62  Outpatient speech-language pathology services: Conditions and 
          exclusions.
410.63  Hepatitis B vaccine and blood clotting factors: Conditions..
410.64  Services related to cardiac pacemakers and pacemaker leads.
410.66  Emergency outpatient services furnished by a nonparticipating 
          hospital and services furnished in Mexico or Canada.
410.68  Antigens: Scope and conditions.
410.69  Services of a certified registered nurse anesthetist or an 
          anesthesiologist's assistant: Basic rule and definitions.
410.71  Clinical psychologist services and services and supplies 
          incident to clinical psychologist services.
410.73  Clinical social worker services.
410.74  Physician assistants' services.
410.75  Nurse practitioners' services.
410.76  Clinical nurse specialists' services.
410.77  Certified nurse-midwives' services: Qualifications and 
          conditions.
410.78  Consultations via telecommunications systems.

                Subpart C--Home Health Services Under SMI

410.80  Applicable rules.

   Subpart D--Comprehensive Outpatient Rehabilitation Facility (CORF) 
                                Services

410.100  Included services.
410.102  Excluded services.
410.105  Requirements for coverage of CORF services.

  Subpart E--Community Mental Health Centers (CMHCs) Providing Partial 
                        Hospitalization Services

410.110  Requirements for coverage of partial hospitalization services 
          by CMHCs.

Subparts F-H--[Reserved]

                   Subpart I--Payment of SMI Benefits

410.150  To whom payment is made.
410.152  Amounts of payment.
410.155  Outpatient mental health treatment limitation.
410.160  Part B annual deductible.
410.161  Part B blood deductible.
410.163  Payment for services furnished to kidney donors.
410.165  Payment for rural health clinic services and ambulatory 
          surgical center services: Conditions.

[[Page 235]]

410.170  Payment for home health services, for medical and other health 
          services furnished by a provider or an approved ESRD facility, 
          and for comprehensive outpatient rehabilitation facility 
          (CORF) services: Conditions.
410.172  Payment for partial hospitalization services in CMHCs: 
          Conditions.
410.175  Alien absent from the United States.

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

    Source: 51 FR 41339, Nov. 14, 1986, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 410 appear at 62 FR 
46037, Aug. 29, 1997.



                      Subpart A--General Provisions



Sec. 410.1  Basis and scope.

    (a) Statutory basis. Section 1832 of the Social Security Act 
establishes the scope of benefits provided under the Medicare Part B 
supplementary medical insurance (SMI) program. Sections 1833, 1834, 
1835, and 1862 set forth the amounts of payment for SMI services, the 
conditions for payment, and the exclusions from coverage. Section 1861 
defines the kinds of services that may be covered. Section 1881 provides 
for Medicare coverage for end stage renal disease patients. Section 4206 
of the Balanced Budget Act of 1997 sets forth the conditions for payment 
for professional consultations that take place by means of 
telecommunications systems.
    (b) Scope of part. This part sets forth the benefits available under 
Medicare Part B, the conditions for payment and the limitations on 
services, the percentage of incurred expenses that Medicare Part B pays, 
and the deductible and copayment amounts for which the beneficiary is 
responsible. (Exclusions applicable to these services are set forth in 
subpart C of part 405 of this chapter. General conditions for Medicare 
payment are set forth in part 424 of this chapter.)

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 55 
FR 53521, Dec. 31, 1990; 59 FR 63462, Dec. 8, 1994; 63 FR 58905, Nov. 2, 
1998]



Sec. 410.2  Definitions.

    As used in this part--
    Community mental health center (CMHC) means an entity that--
    (1) Provides outpatient services, including specialized outpatient 
services for children, the elderly, individuals who are chronically 
mentally ill, and residents of its mental health service area who have 
been discharged from inpatient treatment at a mental health facility;
    (2) Provides 24-hour-a-day emergency care services;
    (3) Provides day treatment or other partial hospitalization 
services, or psychosocial rehabilitation services;
    (4) Provides screening for patients being considered for admission 
to State mental health facilities to determine the appropriateness of 
this admission; and
    (5) Meets applicable licensing or certification requirements for 
CMHCs in the State in which it is located.
    Encounter means a direct personal contact between a patient and a 
physician, or other person who is authorized by State licensure law and, 
if applicable, by hospital or CAH staff bylaws, to order or furnish 
hospital services for diagnosis or treatment of the patient.
    Nominal charge provider means a provider that furnishes services 
free of charge or at a nominal charge, and is either a public provider 
or another provider that (1) demonstrates to HCFA's satisfaction that a 
significant portion of its patients are low-income; and (2) requests 
that payment for its services be determined accordingly.
    Outpatient means a person who has not been admitted as an inpatient 
but who is registered on the hospital or CAH records as an outpatient 
and receives services (rather than supplies alone) directly from the 
hospital or CAH.
    Partial hospitalization services means a distinct and organized 
intensive ambulatory treatment program that offers less than 24-hour 
daily care and furnishes the services described in Sec. 410.43.
    Participating refers to a hospital, CAH, SNF, HHA, CORF, or hospice 
that has in effect an agreement to participate in Medicare; or a clinic, 
rehabilitation agency, or public health agency that has a provider 
agreement to participate in Medicare but only for purposes of providing 
outpatient physical therapy, occupational therapy, or speech pathology 
services; or a CMHC

[[Page 236]]

that has in effect a similar agreement but only for purposes of 
providing partial hospitalization services, and nonparticipating refers 
to a hospital, CAH, SNF, HHA, CORF, hospice, clinic, rehabilitation 
agency, public health agency, or CMHC that does not have in effect a 
provider agreement to participate in Medicare.

[59 FR 6577, Feb. 11, 1994, as amended at 62 FR 46025, Aug. 29, 1997; 65 
FR 18536, Apr. 7, 2000]



Sec. 410.3  Scope of benefits.

    (a) Covered services. The SMI program helps pay for the following:
    (1) Medical and other health services such as physicians' services, 
outpatient services furnished by a hospital or a CAH, diagnostic tests, 
outpatient physical therapy and speech pathology services, rural health 
clinic services, Federally qualified health center services, and 
outpatient renal dialysis services.
    (2) Services furnished by ambulatory surgical centers (ASCs), home 
health agencies (HHAs), comprehensive outpatient rehabilitation 
facilities (CORFs), and partial hospitalization services provided by 
community mental health centers (CMHCs).
    (3) Other medicial services, equipment, and supplies that are not 
covered under Medicare Part A hospital insurance.
    (b) Limitations on amount of payment. (1) Medicare Part B does not 
pay the full reasonable costs or charges for all covered services. The 
beneficiary is responsible for an annual deductible and a blood 
deductible and, after the annual deductible has been satisfied, for 
coinsurance amounts specified for most of the services.
    (2) Specific rules on payment are set forth in subpart E of this 
part.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 24981, June 12, 1992; 
58 FR 30668, May 26, 1993; 59 FR 6577, Feb. 11, 1994]



Sec. 410.5  Other applicable rules.

    The following other rules of this chapter set forth additional 
policies and procedures applicable to four of the kinds of services 
covered under the SMI program:
    (a) Part 405, subpart U: End-Stage Renal Disease services.
    (b) Part 405, Subpart X: Rural Health Clinic and Federally Qualified 
Health Center services.
    (c) Part 416: Ambulatory Surgical Center services.
    (d) Part 493: Laboratory Services.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 7134, Feb. 28, 1992; 57 
FR 24981, June 12, 1992]



              Subpart B--Medical and Other Health Services



Sec. 410.10  Medical and other health services: Included services.

    Subject to the conditions and limitations specified in this subpart, 
``medical and other health services'' includes the following services:
    (a) Physicians' services.
    (b) Services and supplies furnished incident to a physician's 
professional services, of kinds that are commonly furnished in 
physicians' offices and are commonly either furnished without charge or 
included in the physicians' bills.
    (c) Services and supplies, including partial hospitalization 
services, that are incident to physician services and are furnished to 
outpatients by or under arrangements made by a hospital or a CAH.
    (d) Diagnostic services furnished to outpatients by or under 
arrangements made by a hospital or a CAH if the services are services 
that the hospital or CAH ordinarily furnishes to its outpatients for 
diagnostic study.
    (e) Diagnostic laboratory and X-ray tests (including diagnostic 
mammography that meets the conditions for coverage specified in 
Sec. 410.34(b) of this subpart) and other diagnostic tests.
    (f) X-ray therapy and other radiation therapy services.
    (g) Medical supplies, appliances, and devices.
    (h) Durable medical equipment.
    (i) Ambulance services.
    (j) Rural health clinic services.
    (k) Home dialysis supplies and equipment; on or after July 1, 1991, 
epoetin (EPO) for home dialysis patients, and, on or after January 1, 
1994, for dialysis patients, competent to use the drug; self-care home 
dialysis support services; and institutional dialysis services and 
supplies.

[[Page 237]]

    (l) Pneumococcal vaccinations.
    (m) Outpatient physical therapy and speech pathology services.
    (n) Cardiac pacemakers and pacemaker leads.
    (o) Additional services furnished to enrollees of HMOs or CMPs, as 
described in Sec. 410.58.
    (p) Hepatitis B vaccine.
    (q) Blood clotting factors for hemophilia patients competent to use 
these factors without medical or other supervision.
    (r) Screening mammography services.
    (s) Federally qualified health center services.
    (t) Services of a certified registered nurse anesthetist or an 
anesthesiologist's assistant.
    (u) Prescription drugs used in immunosuppressive therapy.
    (v) Clinical psychologist services and services and supplies 
furnished as an incident to the services of a clinical psychologist, as 
provided in Sec. 410.71.
    (w) Clinical social worker services, as provided in Sec. 410.73.

[51 FR 41339, Nov. 14, 1986, as amended at 52 FR 27765, July 23, 1987; 
55 FR 22790, June 4, 1990; 55 FR 53522, Dec. 31, 1990; 56 FR 8841, Mar. 
1, 1991; 56 FR 43709, Sept. 4, 1991; 57 FR 24981, June 12, 1992; 57 FR 
33896, July 31, 1992; 58 FR 30668, May 26, 1993; 59 FR 26959, May 25, 
1994; 59 FR 49833, Sept. 30, 1994; 60 FR 8955, Feb. 16, 1995; 63 FR 
20128, Apr. 23, 1998]



Sec. 410.12  Medical and other health services: Basic conditions and limitations.

    (a) Basic conditions. The medical and other health services 
specified in Sec. 410.10 are covered by Medicare Part B only if they are 
not excluded under subpart A of part 411 of this chapter, and if they 
meet the following conditions:
    (1) When the services must be furnished. The services must be 
furnished while the individual is in a period of entitlement. (The rules 
on entitlement are set forth in part 406 of this chapter.)
    (2) By whom the services must be furnished. The services must be 
furnished by a facility or other entity as specified in Secs. 410.14 
through 410.69.
    (3) Physician certification and recertification requirements. If the 
services are subject to physician certification requirements, they must 
be certified as being medically necessary, and as meeting other 
applicable requirements, in accordance with subpart B of part 424 of 
this chapter.
    (b) Limitations on payment. Payment for medical and other health 
services is subject to limitations on the amounts of payment as 
specified in Secs. 410.152 and 410.155 and to the annual and blood 
deductibles as set forth in Secs. 410.160 and 410.161.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988; 57 
FR 33896, July 31, 1992]



Sec. 410.14  Special requirements for services furnished outside the United States.

    Medicare part B pays for physicians' services and ambulance services 
furnished outside the United States if the services meet the applicable 
conditions of Sec. 410.12 and are furnished in connection with covered 
inpatient hospital services that meet the specific requirements and 
conditions set forth in subpart H of part 424 of this chapter.

[51 FR 41339, Nov. 14, 1986, as amended at 53 FR 6648, Mar. 2, 1988]



Sec. 410.20  Physicians' services.

    (a) Included services. Medicare Part B pays for physicians' 
services, including diagnosis, therapy, surgery, consultations, and 
home, office, and institutional calls.
    (b) By whom services must be furnished. Medicare Part B pays for the 
services specified in paragraph (a) of this section if they are 
furnished by one of the following professionals who is legally 
authorized to practice by the State in which he or she performs the 
functions or actions, and who is acting within the scope of his or her 
license.
    (1) A doctor of medicine or osteopathy, including an osteopathic 
practitioner recognized in section 1101(a)(7) of the Act.
    (2) A doctor of dental surgery or dental medicine.
    (3) A doctor of podiatric medicine.
    (4) A doctor of optometry.
    (5) A chiropractor who meets the qualifications specified in 
Sec. 410.22
    (c) Limitations on services. The Services specified in paragraph (a) 
of this section may be covered under Medicare Part B if they are 
furnished within the

[[Page 238]]

limitations specified in Secs. 410.22 through 410.25.



Sec. 410.22  Limitations on services of a chiropractor.

    (a) Qualifications for chiropractors. (1) A chiropractor licensed or 
authorized to practice before July 1, 1974, and an individual who began 
studies in a chiropractic college before that date, must have--
    (i) Had preliminary education equal to the requirements for 
graduation from an accredited high school or other secondary school;
    (ii) Graduated from a college of chiropractic approved by the 
State's chiropractic examiners after completing a course of study 
covering a period of not less than 3 school years of 6 months each year 
in actual continuous attendance and covering adequate courses of study 
in the subjects of anatomy, physiology, symptomatology and diagnosis, 
hygiene and sanitation, chemistry, histology, pathology, and principles 
and practice of chiropractic, including clinical instruction in 
vertebral palpation, nerve tracing and adjusting; and
    (iii) Passed an examination prescribed by the State's chiropractic 
examiners covering the subjects specified in paragraph (a)(1)(ii) of 
this section.
    (2) A chiropractor first licensed or authorized to practice after 
June 30, 1974, and an individual who begins studies in a chiropractic 
college after that date, must have--
    (i) Had preliminary education equal to the requirements for 
graduation from an accredited high school or other secondary school;
    (ii) Satisfactorily completed 2 years of pre-chiropractic study at 
the college level;
    (iii) Satisfactorily completed a 4-year course of 8 months each year 
offered by a college or school of chiropractic approved by the State's 
chiropractic examiners and including at least 4,000 hours in courses in 
anatomy, physiology, symptomatology and diagnosis, hygiene and 
sanitation, chemistry, histology, pathology, principles and practice of 
chiropractic, and clinical instruction in vertebral palpation, nerve 
tracing and adjusting, plus courses in the use and effect of X-ray and 
chiropractic analysis;
    (iv) Passed an examination prescribed by the State's chiropractic 
examiners covering the subjects specified in paragraph (a)(2)(iii) of 
this section; and
    (v) Attained 21 years of age.
    (b) Limitations on services. (1) Medicare Part B pays only for a 
chiropractor's manual manipulation of the spine to correct a subluxation 
if the subluxation has resulted in a neuromusculoskeletal condition for 
which manual manipulation is appropriate treatment.
    (2) Medicare Part B does not pay for X-rays or other diagnostic or 
therapeutic services furnished or ordered by a chiropractor.

[51 FR 41339, Nov. 14, 1986, as amended at 64 FR 59439, Nov. 2, 1999]



Sec. 410.23  Limitations on services of an optometrist.

    Medicare Part B pays for the services of a doctor of optometry, 
which he or she is legally authorized to perform in the State in which 
he or she performs them, if the services are among those described in 
section 1861(s) of the Act and Sec. 410.10 of this part.

[64 FR 59439, Nov. 2, 1999]



Sec. 410.24  Limitations on services of a doctor of dental surgery or dental medicine.

    Medicare Part B pays for services furnished by a doctor of dental 
surgery or dental medicine within the scope of his or her license, if 
the services would be covered as physicians' services when performed by 
a doctor of medicine or osteopathy.1
---------------------------------------------------------------------------

    \1\ For services furnished before July 1, 1981, Medicare Part B paid 
only for the following services of a doctor of dental surgery or dental 
medicine;
    Surgery on the jaw or any adjoining structure; and
    Reduction of a fracture of the jaw or other facial bone.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 8852, Mar. 1, 1991]

[[Page 239]]



Sec. 410.25  Limitations on services of a podiatrist.

    Medicare Part B pays for the services of a doctor of podiatric 
medicine, acting within the scope of his or her license, if the services 
would be covered as physicians' services when performed by a doctor of 
medicine or osteopathy.



Sec. 410.26  Services and supplies incident to a physician's professional services: Conditions.

    (a) Medicare Part B pays for services and supplies incident to a 
physician's professional services, including drugs and biologicals that 
cannot be self-administered, if the services or supplies are of the type 
that are commonly furnished in a physician's office or clinic, and are 
commonly furnished either without charge, or included in the physician's 
bill.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec. 410.29.



Sec. 410.27  Outpatient hospital services and supplies incident to a physician service: Conditions.

    (a) Medicare Part B pays for hospital services and supplies 
furnished incident to a physician service to outpatients, including 
drugs and biologicals that cannot be self-administered, if--
    (1) They are furnished--
    (i) By or under arrangements made by a participating hospital, 
except in the case of an SNF resident as provided in Sec. 411.15(p) of 
this chapter;
    (ii) As an integral though incidental part of a physician's 
services; and
    (iii) In the hospital or at a location (other than an RHC or an 
FQHC) that HCFA designates as a department of a provider under 
Sec. 413.65 of this chapter; and
    (2) In the case of partial hospitalization services, also meet the 
conditions of paragraph (d) of this section.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec. 410.168.
    (c) Rules on emergency services furnished to outpatients by 
nonparticipating hospitals are specified in Sec. 410.168.
    (d) Medicare Part B pays for partial hospitalization services if 
they are--
    (1) Prescribed by a physician who certifies and recertifies the need 
for the services in accordance with subpart B of part 424 of this 
chapter; and
    (2) Furnished under a plan of treatment as required under subpart B 
of part 424 of this chapter.
    (e) Services furnished by an entity other than the hospital are 
subject to the limitations specified in Sec. 410.42(a).
    (f) Services furnished at a location (other than an RHC or an FQHC) 
that HCFA designates as a department of a provider under Sec. 413.65 of 
this chapter must be under the direct supervision of a physician. 
``Direct supervision'' means the physician must be present and on the 
premises of the location and immediately available to furnish assistance 
and direction throughout the performance of the procedure. It does not 
mean that the physician must be present in the room when the procedure 
is performed.

[56 FR 8841, Mar. 1, 1991, as amended at 63 FR 26307, May 12, 1998; 65 
FR 18536, Apr. 7, 2000]



Sec. 410.28  Hospital or CAH diagnostic services furnished to outpatients: Conditions.

    (a) Medicare Part B pays for hospital or CAH diagnostic services 
furnished to outpatients, including drugs and biologicals required in 
the performance of the services (even if those drugs or biologicals are 
self-administered), if those services meet the following conditions:
    (1) They are furnished by or under arrangements made by a 
participating hospital or participating CAH, except in the case of an 
SNF resident as provided in Sec. 411.15(p) of this chapter.
    (2) They are ordinarily furnished by, or under arrangements made by, 
the hospital or CAH to its outpatients for the purpose of diagnostic 
study.
    (3) They would be covered as inpatient hospital services if 
furnished to an inpatient.
    (b) Drugs and biologicals are also subject to the limitations 
specified in Sec. 410.29(b) and (c).
    (c) Diagnostic services furnished by an entity other than the 
hospital or CAH are subject to the limitations specified in 
Sec. 410.42(a).

[[Page 240]]

    (d) Rules on emergency services furnished to outpatients by 
nonparticipating hospitals are set forth in subpart G of part 424 of 
this chapter.
    (e) Medicare Part B makes payment under section 1833(t) of the Act 
for diagnostic services furnished at a facility (other than an RHC or an 
FQHC) that HCFA designates as having provider-based status only when the 
diagnostic services are furnished under the appropriate level of 
physician supervision specified by HCFA in accordance with the 
definitions in Sec. 410.32(b)(3)(i), (b)(3)(ii), and (b)(3)(iii). Under 
general supervision at a facility accorded provider-based status, the 
training of the nonphysician personnel who actually perform the 
diagnostic procedure and the maintenance of the necessary equipment and 
supplies are the continuing responsibility of the facility.

[51 FR 41339, Nov. 14, 1986, as amended at 58 FR 30668, May 26, 1993; 63 
FR 26307, May 12, 1998; 65 FR 18536, Apr. 7, 2000]



Sec. 410.29  Limitations on drugs and biologicals.

    Medicare part B does not pay for the following:
    (a) Except as provided in Sec. 410.28(a) for outpatient diagnostic 
services and Sec. 410.63(b) for blood clotting factors, and except for 
EPO, any drug or biological that can be self-administered.
    (b) Any drug product that meets all of the following conditions:
    (1) The drug product was approved by the Food and Drug 
Administration (FDA) before October 10, 1962.
    (2) The drug product is available only through prescription.
    (3) The drug product is the subject of a notice of opportunity for 
hearing issued under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act and published in the Federal Register on a proposed order 
of FDA to withdraw its approval for the drug product because it has 
determined that the product is less than effective for all its labeled 
indications.
    (4) The drug product is presently not subject to a determination by 
FDA, made under its efficacy review program, that there is a compelling 
justification of the drug product's medical need. (21 CFR 310.6 contains 
an explanation of the efficacy review program.)
    (c) Any drug product that is identical, related, or similar, as 
defined in 21 CFR 310.6, to a drug product that meets the conditions of 
paragraph (b) of this section.

[51 FR 41339, Nov. 14, 1986, as amended at 55 FR 22790, June 4, 1990; 56 
FR 43709, Sept. 4, 1991]



Sec. 410.30  Prescription drugs used in immunosuppressive therapy.

    (a) Scope. Payment may be made for prescription drugs used in 
immunosuppressive therapy that have been approved for marketing by the 
FDA and that meet one of the following conditions:
    (1) The approved labeling includes the indication for preventing or 
treating the rejection of a transplanted organ or tissue.
    (2) The approved labeling includes the indication for use in 
conjunction with immunosuppressive drugs to prevent or treat rejection 
of a transplanted organ or tissue.
    (3) Have been determined by a carrier (in accordance with part 421, 
subpart C of this chapter), in processing a Medicare claim, to be 
reasonable and necessary for the specific purpose of preventing or 
treating the rejection of a patient's transplanted organ or tissue, or 
for use in conjunction with immunosuppressive drugs for the purpose of 
preventing or treating the rejection of a patient's transplanted organ 
or tissue. (In making these determinations, the carriers may consider 
factors such as authoritative drug compendia, current medical 
literature, recognized standards of medical practice, and professional 
medical publications.)
    (b) Period of eligibility. Coverage is available only for 
prescription drugs used in immunosuppressive therapy, furnished to an 
individual who receives an organ or tissue transplant for which Medicare 
payment is made, for the following periods:
    (1) For drugs furnished before 1995, for a period of up to 1 year 
beginning with the date of discharge from the hospital during which the 
covered transplant was performed.
    (2) For drugs furnished during 1995, within 18 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.

[[Page 241]]

    (3) For drugs furnished during 1996, within 24 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (4) For drugs furnished during 1997, within 30 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (5) For drugs furnished after 1997, within 36 months after the date 
of discharge from the hospital during which the covered transplant was 
performed.
    (c) Coverage. Drugs are covered under this provision irrespective of 
whether they can be self-administered.

[60 FR 8955, Feb. 16, 1995. Redesignated at 63 FR 34327, June 24, 1998]



Sec. 410.31  Bone mass measurement: Conditions for coverage and frequency standards.

    (a) Definition. As used in this section unless specified otherwise, 
the following definition applies:
    Bone mass measurement means a radiologic, radioisotopic, or other 
procedure that meets the following conditions:
    (1) Is performed for the purpose of identifying bone mass, detecting 
bone loss, or determining bone quality.
    (2) Is performed with either a bone densitometer (other than dual-
photon absorptiometry) or with a bone sonometer system that has been 
cleared for marketing for this use by the FDA under 21 CFR part 807, or 
approved for marketing by the FDA for this use under 21 CFR part 814.
    (3) Includes a physician's interpretation of the results of the 
procedure.
    (b) Conditions for coverage. Medicare covers a medically necessary 
bone mass measurement if the following conditions are met:
    (1) Following an evaluation of the beneficiary's need for the 
measurement, including a determination as to the medically appropriate 
procedure to be used for the beneficiary, it is ordered by the physician 
or a qualified nonphysician practitioner (as these terms are defined in 
Sec. 410.32(a)) treating the beneficiary.
    (2) It is performed under the appropriate level of supervision of a 
physician (as set forth in Sec. 410.32(b)).
    (3) It is reasonable and necessary for diagnosing, treating, or 
monitoring the condition of a beneficiary who meets the conditions 
described in paragraph (d) of this section.
    (c) Standards on frequency of coverage--(1) General rule. Except as 
allowed under paragraph (c)(2) of this section, Medicare may cover a 
bone mass measurement for a beneficiary if at least 23 months have 
passed since the month the last bone mass measurement was performed.
    (2) Exception. If medically necessary, Medicare may cover a bone 
mass measurement for a beneficiary more frequently than allowed under 
paragraph (c)(1) of this section. Examples of situations where more 
frequent bone mass measurement procedures may be medically necessary 
include, but are not limited to, the following medical circumstances:
    (i) Monitoring beneficiaries on long-term glucocorticoid (steroid) 
therapy of more than 3 months.
    (ii) Allowing for a confirmatory baseline bone mass measurement 
(either central or peripheral) to permit monitoring of beneficiaries in 
the future if the initial test was performed with a technique that is 
different from the proposed monitoring method.
    (d) Beneficiaries who may be covered. The following categories of 
beneficiaries may receive Medicare coverage for a medically necessary 
bone mass measurement:
    (1) A woman who has been determined by the physician (or a qualified 
nonphysician practitioner) treating her to be estrogen-deficient and at 
clinical risk for osteoporosis, based on her medical history and other 
findings.
    (2) An individual with vertebral abnormalities as demonstrated by an 
x-ray to be indicative of osteoporosis, osteopenia, or vertebral 
fracture.
    (3) An individual receiving (or expecting to receive) glucocorticoid 
(steroid) therapy equivalent to 7.5 mg of prednisone, or greater, per 
day for more than 3 months.
    (4) An individual with primary hyperparathyroidism.
    (5) An individual being monitored to assess the response to or 
efficacy of an FDA-approved osteoporosis drug therapy.
    (e) Denial as not reasonable and necessary. If HCFA determines that 
a bone

[[Page 242]]

mass measurement does not meet the conditions for coverage in paragraphs 
(b) or (d) of this section, or the standards on frequency of coverage in 
paragraph (c) of this section, it is excluded from Medicare coverage as 
not ``reasonable'' and ``necessary'' under section 1862(a)(1)(A) of the 
Act and Sec. 411.15(k) of this chapter.

[63 FR 34327, June 24, 1998]



Sec. 410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

    (a) Ordering diagnostic tests. All diagnostic x-ray tests, 
diagnostic laboratory tests, and other diagnostic tests must be ordered 
by the physician who is treating the beneficiary, that is, the physician 
who furnishes a consultation or treats a beneficiary for a specific 
medical problem and who uses the results in the management of the 
beneficiary's specific medical problem. Tests not ordered by the 
physician who is treating the beneficiary are not reasonable and 
necessary (see Sec. 411.15(k)(1) of this chapter).
    (1) Chiropractic exception. A physician may order an x-ray to be 
used by a chiropractor to demonstrate the subluxation of the spine that 
is the basis for a beneficiary to receive manual manipulation treatments 
even though the physician does not treat the beneficiary.
    (2) Mammography exception. A physician who meets the qualification 
requirements for an interpreting physician under section 354 of the 
Public Health Service Act as provided in Sec. 410.34(a)(7) may order a 
diagnostic mammogram based on the findings of a screening mammogram even 
though the physician does not treat the beneficiary.
    (3) Application to nonphysician practitioners. Nonphysician 
practitioners (that is, clinical nurse specialists, clinical 
psychologists, clinical social workers, nurse-midwives, nurse 
practitioners, and physician assistants) who furnish services that would 
be physician services if furnished by a physician, and who are operating 
within the scope of their authority under State law and within the scope 
of their Medicare statutory benefit, may be treated the same as 
physicians treating beneficiaries for the purpose of this paragraph.
    (b) Diagnostic x-ray and other diagnostic tests--(1) Basic rule. 
Except as indicated in paragraph (b)(2) of this section, all diagnostic 
x-ray and other diagnostic tests covered under section 1861(s)(3) of the 
Act and payable under the physician fee schedule must be furnished under 
the appropriate level of supervision by a physician as defined in 
section 1861(r) of the Act. Services furnished without the required 
level of supervision are not reasonable and necessary (see 
Sec. 411.15(k)(1) of this chapter).
    (2) Exceptions. The following diagnostic tests payable under the 
physician fee schedule are excluded from the basic rule set forth in 
paragraph (b)(1) of this section:
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.
    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological testing services personally furnished 
by a clinical psychologist or a qualified independent psychologist as 
defined in program instructions.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (v) Diagnostic tests performed by a nurse practitioner or clinical 
nurse specialist authorized to perform the tests under applicable State 
laws.
    (vi) Pathology and laboratory procedures listed in the 80000 series 
of the Current Procedural Terminology published by the American Medical 
Association.
    (3) Levels of supervision. Except where otherwise indicated, all 
diagnostic x-ray and other diagnostic tests subject to this provision 
and payable under the physician fee schedule must be furnished under at 
least a general level of physician supervision as defined in paragraph 
(b)(3)(i) of this section. In

[[Page 243]]

addition, some of these tests also require either direct or personal 
supervision as defined in paragraphs (b)(3)(ii) or (b)(3)(iii) of this 
section, respectively. (However, diagnostic tests performed by a 
physician assistant (PA) that the PA is legally authorized to perform 
under State law require only a general level of physician supervision.) 
When direct or personal supervision is required, physician supervision 
at the specified level is required throughout the performance of the 
test.
    (i) General supervision means the procedure is furnished under the 
physician's overall direction and control, but the physician's presence 
is not required during the performance of the procedure. Under general 
supervision, the training of the nonphysician personnel who actually 
perform the diagnostic procedure and the maintenance of the necessary 
equipment and supplies are the continuing responsibility of the 
physician.
    (ii) Direct supervision in the office setting means the physician 
must be present in the office suite and immediately available to furnish 
assistance and direction throughout the performance of the procedure. It 
does not mean that the physician must be present in the room when the 
procedure is performed.
    (iii) Personal supervision means a physician must be in attendance 
in the room during the performance of the procedure.
    (c) Portable x-ray services. Portable x-ray services furnished in a 
place of residence used as the patient's home are covered if the 
following conditions are met:
    (1) These services are furnished under the general supervision of a 
physician, as defined in paragraph (b)(3)(i) of this section.
    (2) The supplier of these services meets the requirements set forth 
in part 486, subpart C of this chapter, concerning conditions for 
coverage for portable x-ray services.
    (3) The procedures are limited to--
    (i) Skeletal films involving the extremities, pelvis, vertebral 
column, or skull;
    (ii) Chest or abdominal films that do not involve the use of 
contrast media; and
    (iii) Diagnostic mammograms if the approved portable x-ray supplier, 
as defined in subpart C of part 486 of this chapter, meets the 
certification requirements of section 354 of the Public Health Service 
Act, as implemented by 21 CFR part 900, subpart B.
    (d) Diagnostic laboratory tests. Medicare Part B pays for covered 
diagnostic laboratory tests that are furnished by any of the following:
    (1) A participating hospital or participating RPCH.
    (2) A nonparticipating hospital that meets the requirements for 
emergency outpatient services specified in subpart G of part 424 of this 
chapter and the laboratory requirements specified in part 493 of this 
chapter.
    (3) The office of the patient's attending or consulting physician if 
that physician is a doctor of medicine, osteopathy, podiatric medicine, 
dental surgery, or dental medicine.
    (4) An RHC.
    (5) A laboratory, if it meets the applicable requirements for 
laboratories of part 493 of this chapter, including the laboratory of a 
nonparticipating hospital that does not meet the requirements for 
emergency outpatient services in subpart G of part 424 of this chapter.
    (6) An FQHC.
    (7) An SNF to its resident under Sec. 411.15(p) of this chapter, 
either directly (in accordance with Sec. 483.75(k)(1)(i) of this 
chapter) or under an arrangement (as defined in Sec. 409.3 of this 
chapter) with another entity described in this paragraph.

[62 FR 59098, Oct. 31, 1997, as amended at 63 FR 26308, May 12, 1998; 63 
FR 53307, Oct. 5, 1998; 63 FR 58906, Nov. 2, 1998; 64 FR 59440, Nov. 2, 
1999]



Sec. 410.33  Independent diagnostic testing facility.

    (a) General rule. (1) Effective for diagnostic procedures performed 
on or after March 15, 1999, carriers will pay for diagnostic procedures 
under the physician fee schedule only when performed by a physician, a 
group practice of physicians, an approved supplier of portable x-ray 
services, a nurse practitioner, or a clinical nurse specialist when he 
or she performs a test he or

[[Page 244]]

she is authorized by the State to perform, or an independent diagnostic 
testing facility (IDTF). An IDTF may be a fixed location, a mobile 
entity, or an individual nonphysician practitioner. It is independent of 
a physician's office or hospital; however, these rules apply when an 
IDTF furnishes diagnostic procedures in a physician's office.
    (2) Exceptions. The following diagnostic tests that are payable 
under the physician fee schedule and furnished by a nonhospital testing 
entity are not required to be furnished in accordance with the criteria 
set forth in paragraphs (b) through (e) of this section:
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.
    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological testing services personally furnished 
by a clinical psychologist or a qualified independent psychologist as 
defined in program instructions.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (b) Supervising physician. (1) An IDTF must have one or more 
supervising physicians who are responsible for the direct and ongoing 
oversight of the quality of the testing performed, the proper operation 
and calibration of the equipment used to perform tests, and the 
qualification of nonphysician personnel who use the equipment. This 
level of supervision is that required for general supervision set forth 
in Sec. 410.32(b)(3)(i).
    (2) The supervising physician must evidence proficiency in the 
performance and interpretation of each type of diagnostic procedure 
performed by the IDTF. The proficiency may be documented by 
certification in specific medical specialties or subspecialties or by 
criteria established by the carrier for the service area in which the 
IDTF is located. In the case of a procedure requiring the direct or 
personal supervision of a physician as set forth in 
Sec. 410.32(b)(3)(ii) or (b)(3)(iii), the IDTF's supervising physician 
must personally furnish this level of supervision whether the procedure 
is performed in the IDTF or, in the case of mobile services, at the 
remote location. The IDTF must maintain documentation of sufficient 
physician resources during all hours of operations to assure that the 
required physician supervision is furnished. In the case of procedures 
requiring direct supervision, the supervising physician may oversee 
concurrent procedures.
    (c) Nonphysician personnel. Any nonphysician personnel used by the 
IDTF to perform tests must demonstrate the basic qualifications to 
perform the tests in question and have training and proficiency as 
evidenced by licensure or certification by the appropriate State health 
or education department. In the absence of a State licensing board, the 
technician must be certified by an appropriate national credentialing 
body. The IDTF must maintain documentation available for review that 
these requirements are met.
    (d) Ordering of tests. All procedures performed by the IDTF must be 
specifically ordered in writing by the physician who is treating the 
beneficiary, that is, the physician who is furnishing a consultation or 
treating a beneficiary for a specific medical problem and who uses the 
results in the management of the beneficiary's specific medical problem. 
(Nonphysician practitioners may order tests as set forth in 
Sec. 410.32(a)(3).) The order must specify the diagnosis or other basis 
for the testing. The supervising physician for the IDTF may not order 
tests to be performed by the IDTF, unless the IDTF's supervising 
physician is in fact the beneficiary's treating physician. That is, the 
physician in question had a relationship with the beneficiary prior to 
the performance of the testing and is treating the beneficiary for a 
specific medical problem. The IDTF may not add any procedures based on 
internal protocols without a written order from the treating physician.
    (e) Multi-State entities. An IDTF that operates across State 
boundaries must maintain documentation that its supervising physicians 
and technicians

[[Page 245]]

are licensed and certified in each of the States in which it is 
furnishing services.
    (f) Applicability of State law. An IDTF must comply with the 
applicable laws of any State in which it operates.

[62 FR 59099, Oct. 31, 1997, as amended at 64 FR 59440, Nov. 2, 1999]



Sec. 410.34  Mammography services: Conditions for and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Diagnostic mammography means a radiologic procedure furnished to 
a man or woman with signs or symptoms of breast disease, or a personal 
history of breast cancer, or a personal history of biopsy-proven benign 
breast disease, and includes a physician's interpretation of the results 
of the procedure.
    (2) Screening mammography means a radiologic procedure furnished to 
a woman without signs or symptoms of breast disease, for the purpose of 
early detection of breast cancer, and includes a physician's 
interpretation of the results of the procedure.
    (3) Supplier of diagnostic mammography means a facility that is 
certified and responsible for ensuring that all diagnostic mammography 
services furnished to Medicare beneficiaries meet the conditions for 
coverage of diagnostic mammography services as specified in paragraph 
(b) of this section.
    (4) Supplier of screening mammography means a facility that is 
certified and responsible for ensuring that all screening mammography 
services furnished to Medicare beneficiaries meet the conditions and 
limitations for coverage of screening mammography services as specified 
in paragraphs (c) and (d) of this section.
    (5) Certificate means the certificate described in 21 CFR 900.2(b) 
that may be issued to, or renewed for, a facility that meets the 
requirements for conducting an examination or procedure involving 
mammography.
    (6) Provisional certificate means the provisional certificate 
described in 21 CFR 900.2(m) that may be issued to a facility to enable 
the facility to qualify to meet the requirements for conducting an 
examination or procedure involving mammography.
    (7) The term meets the certification requirements of section 354 of 
the Public Health Service (PHS) Act means that in order to qualify for 
coverage of its services under the Medicare program, a supplier of 
diagnostic or screening mammography services must meet the following 
requirements:
    (i) Must have a valid provisional certificate, or a valid 
certificate, that has been issued by FDA indicating that the supplier 
meets the certification requirements of section 354 of the PHS Act, as 
implemented by 21 CFR part 900, subpart B.
    (ii) Has not been issued a written notification by FDA that states 
that the supplier must cease conducting mammography examinations because 
the supplier is not in compliance with certain critical certification 
requirements of section 354 of the PHS Act, implemented by 21 CFR part 
900, subpart B.
    (iii) Must not employ for provision of the professional component of 
mammography services a physician or physicians for whom the facility has 
received written notification by FDA that the physician (or physicians) 
is (or are) in violation of the certification requirements set forth in 
section 354 of the PHS Act, as implemented by 21 CFR 900.12(a)(1)(i).
    (b) Conditions for coverage of diagnostic mammography services. 
Medicare Part B pays for diagnostic mammography services if they meet 
the following conditions:
    (1) They are ordered by a doctor of medicine or osteopathy (as 
defined in section 1861(r)(1) of the Act).
    (2) They are furnished by a supplier of diagnostic mammography 
services that meets the certification requirements of section 354 of the 
PHS Act, as implemented by 21 CFR part 900, subpart B.
    (c) Conditions for coverage of screening mammography services. 
Medicare Part B pays for screening mammography services if they are 
furnished by a supplier of screening mammography services that meets the 
certification requirements of section 354 of the PHS Act, as implemented 
by 21 CFR part 900, subpart B.
    (d) Limitations on coverage of screening mammography services. The 
following limitations apply to coverage of

[[Page 246]]

screening mammography services as described in paragraphs (c) and (d) of 
this section:
    (1) The service must be, at a minimum a two-view exposure (that is, 
a cranio-caudal and a medial lateral oblique view) of each breast.
    (2) Payment may not be made for screening mammography performed on a 
woman under age 35.
    (3) Payment may be made for only 1 screening mammography performed 
on a woman over age 34, but under age 40.
    (4) For an asymptomatic woman over 39 years of age, payment may be 
made for a screening mammography performed after at least 11 months have 
passed following the month in which the last screening mammography was 
performed.

[59 FR 49833, Sept. 30, 1994, as amended at 60 FR 14224, Mar. 16, 1995; 
60 FR 63176, Dec. 8, 1995; 62 FR 59100, Oct. 31, 1997; 63 FR 4596, Jan. 
30, 1998]



Sec. 410.35  X-ray therapy and other radiation therapy services: Scope.

    Medicare Part B pays for X-ray therapy and other radiation therapy 
services, including radium therapy and radioactive isotope therapy, and 
materials and the services of technicians administering the treatment.

[51 FR 41339, Nov. 14, 1986. Redesignated at 55 FR 53522, Dec. 31, 1990]



Sec. 410.36  Medical supplies, appliances, and devices: Scope.

    (a) Medicare Part B pays for the following medical supplies, 
appliances and devices:
    (1) Surgical dressings, and splints, casts, and other devices used 
for reduction of fractures and dislocations.
    (2) Prosthetic devices, other than dental, that replace all or part 
of an internal body organ, including colostomy bags and supplies 
directly related to colostomy care, including--
    (i) Replacement of prosthetic devices; and
    (ii) One pair of conventional eyeglasses or conventional contact 
lenses furnished after each cataract surgery during which an intraocular 
lens is inserted.
    (3) Leg, arm, back, and neck braces and artificial legs, arms, and 
eyes, including replacements if required because of a change in the 
individual's physical condition.
    (b) As a requirement for payment, HCFA may determine through carrier 
instructions, or carriers may determine, that an item listed in 
paragraph (a) of this section requires a written physician order before 
delivery of the item.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 36014, Aug. 12, 1992; 
57 FR 57688, Dec. 7, 1992]



Sec. 410.37  Colorectal cancer screening tests: Conditions for and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Colorectal cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of colorectal cancer:
    (i) Screening fecal-occult blood tests.
    (ii) Screening flexible sigmoidoscopies.
    (iii) In the case of an individual at high risk for colorectal 
cancer, screening colonoscopies.
    (iv) Screening barium enemas.
    (v) Other tests or procedures, and modifications to tests under this 
paragraph, with such frequency and payment limits as HCFA determines 
appropriate, in consultation with appropriate organizations.
    (2) Screening fecal-occult blood test means a guaiac-based test for 
peroxidase activity, testing two samples from each of three consecutive 
stools.
    (3) An individual at high risk for colorectal cancer means an 
individual with--
    (i) A close relative (sibling, parent, or child) who has had 
colorectal cancer or an adenomatous polyp;
    (ii) A family history of familial adenomatous polyposis;
    (iii) A family history of hereditary nonpolyposis colorectal cancer;
    (iv) A personal history of adenomatous polyps; or
    (v) A personal history of colorectal cancer; or
    (vi) Inflammatory bowel disease, including Crohn's Disease, and 
ulcerative colitis.
    (4) Screening barium enema means--

[[Page 247]]

    (i) A screening double contrast barium enema of the entire 
colorectum (including a physician's interpretation of the results of the 
procedure); or
    (ii) In the case of an individual whose attending physician decides 
that he or she cannot tolerate a screening double contrast barium enema, 
a screening single contrast barium enema of the entire colorectum 
(including a physician's interpretation of the results of the 
procedure).
    (5) An attending physician for purposes of this provision is a 
doctor of medicine or osteopathy (as defined in section 1861(r)(1) of 
the Act) who is fully knowledgeable about the beneficiary's medical 
condition, and who would be responsible using the results of any 
examination performed in the overall management of the beneficiary's 
specific medical problem.
    (b) Condition for coverage of screening fecal-occult blood tests. 
Medicare Part B pays for a screening fecal-occult blood test if it is 
ordered in writing by the beneficiary's attending physician.
    (c) Limitations on coverage of screening fecal-occult blood tests. 
(1) Payment may not be made for a screening fecal-occult blood test 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, payment may be made 
for a screening fecal-occult blood test performed after at least 11 
months have passed following the month in which the last screening 
fecal-occult blood test was performed.
    (d) Condition for coverage of screening flexible sigmoidoscopies. 
Medicare Part B pays for a screening flexible sigmoidoscopy service if 
it is performed by a doctor of medicine or osteopathy (as defined in 
section 1861(r)(1) of the Act).
    (e) Limitations on coverage of screening flexible sigmoidoscopies. 
(1) Payment may not be made for a screening flexible sigmoidoscopy 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, payment may be made 
for a screening flexible sigmoidoscopy after at least 47 months have 
passed following the month in which the last screening flexible 
sigmoidoscopy or, as provided in paragraphs (h) and (i) of this section, 
the last screening barium enema was performed.
    (f) Condition for coverage of screening colonoscopies. Medicare Part 
B pays for a screening colonoscopy if it is performed by a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act).
    (g) Limitations on coverage of screening colonoscopies. (1) Payment 
may not be made for a screening colonoscopy for an individual who is not 
at high risk for colorectal cancer as described in paragraph (a)(3) of 
this section.
    (2) Payment may be made for a screening colonoscopy performed for an 
individual who is at high risk for colorectal cancer as described in 
paragraph (a)(3) of this section, after at least 23 months have passed 
following the month in which the last screening colonoscopy was 
performed, or as provided in paragraphs (h) and (i) of this section, the 
last screening barium enema was performed.
    (h) Conditions for coverage of screening barium enemas. Medicare 
Part B pays for a screening barium enema if it is ordered in writing by 
the beneficiary's attending physician.
    (i) Limitations on coverage of screening barium enemas. (1) In the 
case of an individual age 50 or over who is not at high risk of 
colorectal cancer, payment may be made for a screening barium enema 
examination performed after at least 47 months have passed following the 
month in which the last screening barium enema or screening flexible 
sigmoidoscopy was performed.
    (2) In the case of an individual who is at high risk for colorectal 
cancer, payment may be made for a screening barium enema examination 
performed after at least 23 months have passed following the month in 
which the last screening barium enema or the last screening colonoscopy 
was performed.

[62 FR 59100, Oct. 31, 1997]



Sec. 410.38  Durable medical equipment: Scope and conditions.

    (a) Medicare Part B pays for the rental or purchase of durable 
medical equipment, including iron lungs, oxygen tents, hospital beds, 
and wheelchairs, if the equipment is used in the patient's home or in an 
institution that is used as a home.

[[Page 248]]

    (b) An institution that is used as a home may not be a hospital or a 
CAH or a SNF as defined in sections 1861(e)(1), 1861(mm)(1) and 
1819(a)(1) of the Act, respectively.
    (c) Wheelchairs may include a power-operated vehicle that may be 
appropriately used as a wheelchair, but only if the vehicle--
    (1) Is determined to be necessary on the basis of the individual's 
medical and physical condition;
    (2) Meets any safety requirements specified by HCFA; and
    (3) Except as provided in paragraph (c)(2) of this section, is 
ordered in writing by a specialist in physical medicine, orthopedic 
surgery, neurology, or rheumatology, the written order is furnished to 
the supplier before the delivery of the vehicle to the beneficiary, and 
the beneficiary requires the vehicle and is capable of using it.
    (4) A written prescription from the beneficiary's physician is 
acceptable for ordering a power-operated vehicle if a specialist in 
physical medicine, orthopedic surgery, neurology, or rheumatology is not 
reasonably accessible. For example, if travel to the specialist would be 
more than one day's trip from the beneficiary's home or if the 
beneficiary's medical condition precluded travel to the nearest 
available specialist, these circumstances would satisfy the ``not 
reasonably accessible'' requirement.
    (d) Medicare Part B pays for medically necessary equipment that is 
used for treatment of decubitus ulcers if--
    (1) The equipment is ordered in writing by the beneficiary's 
attending physician, or by a specialty physician on referral from the 
beneficiary's attending physician, and the written order is furnished to 
the supplier before the delivery of the equipment; and
    (2) The prescribing physician has specified in the prescription that 
he or she will be supervising the use of the equipment in connection 
with the course of treatment.
    (e) Medicare Part B pays for a medically necessary seat-lift if it--
    (1) Is ordered in writing by the beneficiary's attending physician, 
or by a specialty physician on referral from the beneficiary's attending 
physician, and the written order is furnished to the supplier before the 
delivery of the seat-lift;
    (2) Is for a beneficiary who has a diagnosis designated by HCFA as 
requiring a seat-lift; and
    (3) Meets safety requirements specified by HCFA.
    (f) Medicare Part B pays for transcutaneous electrical nerve 
stimulator units that are--
    (1) Determined to be medically necessary; and
    (2) Ordered in writing by the beneficiary's attending physician, or 
by a specialty physician on referral from the beneficiary's attending 
physician, and the written order is furnished to the supplier before the 
delivery of the unit to the beneficiary.
    (g) As a requirement for payment, HCFA may determine through carrier 
instructions, or carriers may determine that an item of durable medical 
equipment requires a written physician order before delivery of the 
item.

[51 FR 41339, Nov. 14, 1986, as amended at 57 FR 57688, Dec. 7, 1992; 58 
FR 30668, May 26, 1993]



Sec. 410.39  Prostate cancer screening tests: Conditions for and limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Prostate cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of prostate cancer:
    (i) A screening digital rectal examination.
    (ii) A screening prostate-specific antigen blood test.
    (iii) For years beginning after 2002, other procedures HCFA finds 
appropriate for the purpose of early detection of prostate cancer, 
taking into account changes in technology and standards of medical 
practice, availability, effectiveness, costs, and other factors HCFA 
considers appropriate.
    (2) A screening digital rectal examination means a clinical 
examination of an individual's prostate for nodules or other 
abnormalities of the prostate.
    (3) A screening prostate-specific antigen blood test means a test 
that measures the level of prostate-specific antigen in an individual's 
blood.

[[Page 249]]

    (4) A physician for purposes of this provision means a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act) who 
is fully knowledgeable about the beneficiary, and who would be 
responsible for explaining the results of the screening examination or 
test.
    (5) A physician assistant, nurse practitioner, clinical nurse 
specialist, or certified nurse midwife for purposes of this provision 
means a physician assistant, nurse practitioner, clinical nurse 
specialist, or certified nurse midwife (as defined in sections 1861(aa) 
and 1861(gg) of the Act) who is fully knowledgeable about the 
beneficiary, and who would be responsible for explaining the results of 
the screening examination or test.
    (b) Condition for coverage of screening digital rectal examinations. 
Medicare Part B pays for a screening digital rectal examination if it is 
performed by the beneficiary's physician, or by the beneficiary's 
physician assistant, nurse practitioner, clinical nurse specialist, or 
certified nurse midwife as defined in paragraphs (a)(4) or (a)(5) of 
this section who is authorized to perform this service under State law.
    (c) Limitation on coverage of screening digital rectal examinations. 
(1) Payment may not be made for a screening digital rectal examination 
performed for a man age 50 or younger.
    (2) For an individual over 50 years of age, payment may be made for 
a screening digital rectal examination only if the man has not had such 
an examination paid for by Medicare during the preceding 11 months 
following the month in which his last Medicare-covered screening digital 
rectal examination was performed.
    (d) Condition for coverage of screening prostate-specific antigen 
blood tests. Medicare Part B pays for a screening prostate-specific 
antigen blood test if it is ordered by the beneficiary's physician, or 
by the beneficiary's physician assistant, nurse practitioner, clinical 
nurse specialist, or certified nurse midwife as defined in paragraphs 
(a)(4) or (a)(5) of this section who is authorized to order this test 
under State law.
    (e) Limitation on coverage of screening prostate-specific antigen 
blood test. (1) Payment may not be made for a screening prostate-
specific antigen blood test performed for a man age 50 or younger.
    (2) For an individual over 50 years of age, payment may be made for 
a screening prostate-specific antigen blood test only if the man has not 
had such an examination paid for by Medicare during the preceding 11 
months following the month in which his last Medicare-covered screening 
prostate-specific antigen blood test was performed.

[64 FR 59440, Nov. 2, 1999, as amended at 65 FR 19331, Apr. 11, 2000]



Sec. 410.40  Coverage of ambulance services.

    (a). Basic rules. Medicare Part B covers ambulance services if the 
following conditions are met:
    (1) The supplier meets the applicable vehicle, staff, and billing 
and reporting requirements of Sec. 410.41 and the service meets the 
medical necessity and origin and destination requirements of paragraphs 
(d) and (e) of this section.
    (2) Medicare Part A payment is not made directly or indirectly for 
the services.
    (b) Levels of services. Medicare covers ambulance services within 
the United States at the following levels of services:
    (1) Basic life support (BLS) services.
    (2) Advanced life support (ALS) services.
    (3) Paramedic ALS intercept services described in paragraph (c) of 
this section.
    (c) Paramedic ALS intercept services. Paramedic ALS intercept 
services must meet the following requirements:
    (1) Be furnished in an area that is designated as a rural area by 
any law or regulation of the State or that is located in a rural census 
tract of a metropolitan statistical area (as determined under the most 
recent Goldsmith Modification). (The Goldsmith Modification is a 
methodology to identify small towns and rural areas within large 
metropolitan counties that are isolated from central areas by distance 
or other features.)
    (2) Be furnished under contract with one or more volunteer ambulance 
services that meet the following conditions:

[[Page 250]]

    (i) Are certified to furnish ambulance services as required under 
Sec. 410.41.
    (ii) Furnish services only at the BLS level.
    (iii) Be prohibited by State law from billing for any service.
    (3) Be furnished by a paramedic ALS intercept supplier that meets 
the following conditions:
    (i) Is certified to furnish ALS services as required in 
Sec. 410.41(b)(2).
    (ii) Bills all the recipients who receive ALS intercept services fro 
the entity, regardless of whether or not those recipients are Medicare 
beneficiaries.
    (d) Medical necessity requirements--(1) General rule. Medicare 
covers ambulance services only if they are furnished to a beneficiary 
whose medical condition is such that other means of transportation would 
be contraindicated. For nonemergency ambulance transportation, the 
following criteria must be met to ensure that ambulance transportation 
is medically necessary:
    (i) The beneficiary is unable to get up from bed without assistance.
    (ii) The beneficiary is unable to ambulate.
    (iii) The beneficiary is unable to sit in a chair or wheelchair.
    (2) Special rule for nonemergency, scheduled ambulance services. 
Medicare covers nonemergency, scheduled ambulance services if the 
ambulance supplier, before furnishing the service to the beneficiary, 
obtains a written order from the beneficiary's attending physician 
certifying that the medical necessity requirements of paragraph (d)(1) 
of this section are met. The physician's order must be dated no earlier 
than 60 days before the date the service is furnished.
    (3) Special rule for nonemergency, unscheduled ambulance services. 
Medicare covers nonemergency, unscheduled ambulance services under the 
following circumstances:
    (i) For a resident of a facility who is under the care of a 
physician if the ambulance supplier obtains a written order from the 
beneficiary's attending physician, within 48 hours after the transport, 
certifying that the medical necessity requirements of paragraph (d)(1) 
of this section are met.
    (ii) For a beneficiary residing at home or in a facility who is not 
under the direct care of a physician. A physician certification is not 
required.
    (e) Origin and destination requirements. Medicare covers the 
following ambulance transportation:
    (1) From any point of origin to the nearest hospital, CAH, or SNF 
that is capable of furnishing the required level and type of care for 
the beneficiary's illness or injury. The hospital or CAH must have 
available the type of physician or physician specialist needed to treat 
the beneficiary's condition.
    (2) From a hospital, CAH, or SNF to the beneficiary's home.
    (3) From a SNF to the nearest supplier of medically necessary 
services not available at the SNF where the beneficiary is a resident, 
including the return trip.
    (4) For a beneficiary who is receiving renal dialysis for treatment 
of ESRD, from the beneficiary's home to the nearest facility that 
furnishes renal dialysis, including the return trip.
    (f) Specific limits on coverage of ambulance services outside the 
United States. If services are furnished outside the United States, 
Medicare Part B covers ambulance transportation to a foreign hospital 
only in conjunction with the beneficiary's admission for medically 
necessary inpatient services as specified in subpart H of part 424 of 
this chapter.

[64 FR 3648, Jan. 25, 1999, as amended at 65 FR 13914, Mar. 15, 2000]



Sec. 410.41  Requirements for ambulance suppliers.

    (a) Vehicle. A vehicle used as an ambulance must meet the following 
requirements:
    (1) Be specially designed to respond to medical emergencies or 
provide acute medical care to transport the sick and injured and comply 
with all State and local laws governing an emergency transportation 
vehicle.
    (2) Be equipped with emergency warning lights and sirens, as 
required by State or local laws.
    (3) Be equipped with telecommunications equipment as required by 
State or local law to include, at a minimum, one two-way voice radio or 
wireless telephone.

[[Page 251]]

    (4) Be equipped with a stretcher, linens, emergency medical 
supplies, oxygen equipment, and other lifesaving emergency medical 
equipment as required by State or local laws.
    (b) Vehicle staff--(1) BLS vehicles. A vehicle furnishing ambulance 
services must be staffed by at least two people, one of whom must meet 
the following requirements:
    (i) Be certified as an emergency medical technician by the State or 
local authority where the services are furnished.
    (ii) Be legally authorized to operate all lifesaving and life-
sustaining equipment on board the vehicle.
    (2) ALS vehicles. In addition to meeting the vehicle staff 
requirements of paragraph (b)(1) of this section, one of the two staff 
members must be certified as a paramedic or an emergency medical 
technician, by the State or local authority where the services are being 
furnished, to perform one or more ALS services.
    (c) Billing and reporting requirements. An ambulance supplier must 
comply with the following requirements:
    (1) Bill for ambulance services using HCFA-designated procedure 
codes to describe origin and destination and indicate on claims form 
that the physician certification is on file.
    (2) Upon a carrier's request, complete and return the ambulance 
supplier form designated by HCFA and provide the Medicare carrier with 
documentation of compliance with emergency vehicle and staff licensure 
and certification requirements in accordance with State and local laws.
    (3) Upon a carrier's request, provide additional information and 
documentation as required.

[64 FR 3648, Jan. 25, 1999]



Sec. 410.42  Limitations on coverage of certain services furnished to hospital outpatients.

    (a) General rule. Except as provided in paragraph (b) of this 
section, Medicare Part B does not pay for any item or service that is 
furnished to a hospital outpatient (as defined in Sec. 410.2) during an 
encounter (as defined in Sec. 410.2) by an entity other than the 
hospital unless the hospital has an arrangement (as defined in 
Sec. 409.3 of this chapter) with that entity to furnish that particular 
service to its patients. As used in this paragraph, the term 
``hospital'' includes a CAH.
    (b) Exception. The limitations stated in paragraph (a) of this 
section do not apply to the following services:
    (1) Physician services that meet the requirements of Sec. 415.102(a) 
of this chapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse mid-wife services, as defined in section 
1861(gg) of the Act.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (6) Services of an anesthetist, as defined in Sec. 410.69.
    (7) Services furnished to SNF residents as defined in Sec. 411.15(p) 
of this chapter.

[65 FR 18536, Apr. 7, 2000]



Sec. 410.43  Partial hospitalization services: Conditions and exclusions.

    (a) Partial hospitalization services are services that--
    (1) Are reasonable and necessary for the diagnosis or active 
treatment of the individual's condition;
    (2) Are reasonably expected to improve or maintain the individual's 
condition and functional level and to prevent relapse or 
hospitalization; and
    (3) Include any of the following:
    (i) Individual and group therapy with physicians or psychologists or 
other mental health professionals to the extent authorized under State 
law.
    (ii) Occupational therapy requiring the skills of a qualified 
occupational therapist.
    (iii) Services of social workers, trained psychiatric nurses, and 
other staff trained to work with psychiatric patients.
    (iv) Drugs and biologicals furnished for therapeutic purposes, 
subject to the limitations specified in Sec. 410.29.
    (v) Individualized activity therapies that are not primarily 
recreational or diversionary.

[[Page 252]]

    (vi) Family counseling, the primary purpose of which is treatment of 
the individual's condition.
    (vii) Patient training and education, to the extent the training and 
educational activities are closely and clearly related to the 
individual's care and treatment.
    (viii) Diagnostic services.
    (b) The following services are separately covered and not paid as 
partial hospitalization services:
    (1) Physician services that meet the requirements of Sec. 415.102(a) 
of this chapter for payment on a fee schedule basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Qualified psychologist services, as defined in section 1861(ii) 
of the Act.
    (5) Services furnished to SNF residents as defined in Sec. 411.15(p) 
of this chapter.

[59 FR 6577, Feb. 11, 1994, as amended at 65 FR 18536, Apr. 7, 2000]



Sec. 410.45  Rural health clinic services: Scope and conditions.

    (a) Medicare Part B pays for the following rural health clinic 
services, if they are furnished in accordance with the requirements and 
conditions specified in part 405, subpart X, and part 491 of this 
chapter:
    (1) Physicians' services.
    (2) Services and supplies furnished as an incident to physicians' 
professional services.
    (3) Nurse practitioner and physician assistant services.
    (4) Services and supplies furnished as an incident to nurse 
practitioners' or physician assistants' services.
    (5) Visiting nurse services.
    (b) Medicare pays for rural health clinic services when they are 
furnished at the clinic, at a hospital or other medical facility, or at 
the beneficiary's place of residence.



Sec. 410.50  Institutional dialysis services and supplies: Scope and conditions.

    Medicare Part B pays for the following institutional dialysis 
services and supplies if they are furnished in approved ESRD facilities:
    (a) All services, items, supplies, and equipment necessary to 
perform dialysis and drugs medically necessary in the treatment of the 
patient for ESRD.
    (b) Routine dialysis monitoring tests (i.e., hematocrit and clotting 
time) used by the facility to monitor the patients' fluids incident to 
each dialysis treatment, when performed by qualified staff of the 
facility under the direction of a physician, as provided in 
Sec. 405.2163(b) of this chapter, even if the facility does not meet the 
conditions for coverage of services of independent laboratories in 
subpart M of part 405 of this chapter.
    (c) Routine diagnostic tests.
    (d) Epoetin (EPO) and its administration.

[51 FR 41339, Nov. 14, 1986, as amended at 56 FR 43709, Sept. 4, 1991; 
59 FR 1285, Jan. 10, 1994]



Sec. 410.52  Home dialysis services, supplies, and equipment: Scope and conditions.

    (a) Medicare Part B pays for the following services, supplies, and 
equipment furnished to an ESRD patient in his or her home:
    (1) Purchase or rental, installation, and maintenance of all 
dialysis equipment necessary for home dialysis, and reconditioning of 
this equipment. Dialysis equipment includes, but is not limited to, 
artificial kidney and automated peritoneal dialysis machines, and 
support equipment such as blood pumps, bubble detectors, and other alarm 
systems.
    (2) Items and supplies required for dialysis, including (but not 
limited to) dialyzers, syringes and needles, forceps, scissors, scales, 
sphygmomanometer with cuff and stethoscope, alcohol wipes, sterile 
drapes, and rubber gloves.
    (3) Home dialysis support services furnished by an approved ESRD 
faci