[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Rules and Regulations]
[Pages 50439-50443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24382]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Chapter IV

[BPD-830-FC]


Medicare Program; Authority Citations: Technical Amendments

ACTION: Final rule with comment period.

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SUMMARY: This technical regulation provides uniform simplified 
authority citations for most of the parts that pertain to the Medicare 
program, and revises the sections or paragraphs that explain the 
statutory basis for the substance of the rules.
    These changes are consistent with the use of authority citations 
and paragraphs identified as ``statutory basis'' in the regulations 
that pertain to the Medicaid program.
    They are intended to put an end to the continual changing of the 
current lengthy authority citations and, by clarifying and, where 
needed, expanding the ``statutory basis'' portions, ensure better 
understanding of that basis.

DATES: Effective date: These rules are effective as of September 29, 
1995.
    Comment date: We will consider comments received by: November 28, 
1995.

ADDRESSES: Please mail written comments (an original and 3 copies) to 
the following address: Health Care Financing Administration, Department 
of Health and Human Services, Attention: BPD-830-FC, P.O. Box 7195, 
Baltimore, MD 21207.
    If you prefer, you may deliver your written comments (original and 
3 copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, 
Washington, DC 20201-0001, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code BPD-830-FC. Comments received timely will be available for 
public inspection as they are received, generally beginning 
approximately 3 weeks after publication of the document, in Room 309-G 
of the Department's offices at 200 Independence Avenue, SW, Washington, 
DC, Monday through Friday of each week from 8:30 a.m. to 5 p.m., phone: 
(202) 690-7890.

FOR FURTHER INFORMATION CONTACT: Luisa V. Iglesias (202) 690-6383.

SUPPLEMENTARY INFORMATION:

Background

    In 1978 we revised, reorganized, and redesignated the Medicaid 
regulations. At that time we simplified the authority citations to 
limit them to those statutory 

[[Page 50440]]
provisions that explicitly authorize issuance of regulations, and to 
add to each part of the rules a section or paragraph to explain the 
statutory provisions that are implemented by the part.
    Recently, we have begun to use the same kind of authority citations 
and explanations in the Medicare regulations.

Provisions of the Regulations

    By establishing the simplified authority citation for most of the 
parts of the HCFA rules that pertain to Medicare, we--
     Make it unnecessary to keep revising individual citations 
as different parts are amended by newly issued regulations;
     Achieve consistency with the Medicaid regulations; and
     Provide guidance to readers with respect to the statutory 
basis of the rules.
    For parts that have subparts dealing with very different subject 
matter, it is sometimes preferable to have ``statutory basis'' sections 
or paragraphs in each subpart. These clarifying additions do not affect 
the substance of the rules.
    In part 414, we have made a nomenclature change for consistent use 
of the term ``physician services''.

Collection of Information Requirements

    This rule contains no new information collection requirements 
subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).

Response to Comments

    Although this is a final rule, we will consider timely comments 
from anyone who believes that, in making these technical changes we 
have unintentionally altered the substance of the rule. If we revise 
this rule as a result of comments, we will discuss all timely comments 
in the preamble to the revised rule.

Waiver of Proposed Rulemaking and Delayed Effective Date

    The changes made by this rule are technical and editorial in nature 
and do not alter the substance of the regulations. Their aim is to 
simplify the authority citations to limit them to statutory sections 
that explicitly authorize or require issuance of regulations. 
Accordingly, we find that there is good cause to waive proposed 
rulemaking procedures as unnecessary.
    In addition, it is important, for the convenience of the public, 
that these technical changes be effective as of October 1, 1995 so that 
they will be included in the 1995 edition of the Code of Federal 
Regulations on which the public relies. Accordingly, we find that there 
is also good cause to waive the usual 30-day delay in the effective 
date.

Regulatory Flexibility Statement

    Consistent with the Regulatory Flexibility Act (RFA) and section 
1102(b) of the Social Security Act, we prepare a regulatory flexibility 
analysis for each rule, unless we can certify that the particular rule 
will not have a significant economic impact on a substantial number of 
small entities, or a significant impact on the operation of a 
substantial number of small rural hospitals.
    The RFA defines ``small entity'' as a small business, a nonprofit 
enterprise, or a government jurisdiction (such as a county, city, or 
township) with a population of less than 50,000. We also consider all 
providers and suppliers of services to be small entities. For purposes 
of section 1102 of the Act, we define a small rural hospital as a 
hospital that has fewer than 50 beds and is not located in a 
Metropolitan Statistical Area.
    We have not prepared a regulatory flexibility analysis because we 
have determined and we certify that these rules will not have a 
significant economic impact on a substantial number of small entities 
or a significant impact on the operation of a substantial number of 
small rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
rule was not reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 401

    Claims, Freedom of information, Health facilities, Medicare, 
Privacy.

42 CFR Part 403

    Health insurance, Hospitals, Intergovernmental relations, Medicare, 
Reporting and recordkeeping requirements.

42 CFR Part 406

    Health facilities, Kidney diseases, Medicare.

42 CFR Part 407

    Medicare.

42 CFR Part 408

    Medicare.

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 411

    Kidney diseases, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 412

    Administrative practice and procedure, Health facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 413

    Health facilities, Kidney diseases, Medicare, Puerto Rico, 
Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements, Rural areas, X-rays.

42 CFR Part 416

    Health facilities, Kidney diseases, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 420

    Fraud, Health facilities, Health professions, Medicare.

42 CFR Part 421

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare.

42 CFR Part 462

    Grant programs-health, Health care, Health professions, Peer Review 
Organizations (PRO)

42 CFR Part 466

    Grant programs-health, Health care, Health facilities, Health 
professions, Peer Review Organizations (PRO), Reporting and 
recordkeeping requirements.

42 CFR Part 473

    Administrative practice and procedure, Health care, Health 
professions, Peer Review Organizations (PRO), Reporting and 
recordkeeping requirements.

42 CFR Part 476

    Health care, Health professional, Health record, Peer Review 
Organizations (PRO), Penalties, Privacy, 

[[Page 50441]]
Reporting and recordkeeping requirements.

42 CFR Part 482

    Grant programs-health, Hospitals, Medicaid, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 483

    Grant programs-health , Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 484

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 488

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 489

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 498

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.
    42 CFR Chapter IV is amended as set forth below.
    A. In the following parts, the authority citation is revised to 
read as set forth below:
    Parts 406, 407, 408, 411, 412, 416, 418, 462, 466, 476, 489, and 
498.

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

PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS

    B. In part 401, the following changes are made:
    1. The authority citation for part 401, which was published at 59 
FR 56232 (November 10, 1994) is removed and the following authority 
citation is added at the end of the table of contents:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1895hh). Subpart F is also issued under the 
authority of the Federal Claims Collection Act (31 U.S.C. 3711).

    2. The authority citations at the beginning of subparts B and F are 
removed.

PART 403--SPECIAL PROGRAMS AND PROJECTS

    C. Part 403 is amended as set forth below.
    1. The following authority citation is added at the end of the 
table of contents:

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

    2. The authority citations at the beginning of subparts B, C and E 
are removed.

PART 409--HOSPITAL INSURANCE BENEFITS

    D. Part 409 is amended as set forth below.
    1. The authority citation for part 409 is revised to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act 
(U.S.C.1302 and 1895hh).

    2. Section 409.1 is revised to read as follows:


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 rural primary care 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.

PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR 
END-STAGE RENAL DISEASE SERVICES

    E. Part 413 is amended as set forth below.
    1. The authority citation for part 413 continues to read as 
follows:

    Authority: Secs. 1102, 1861(v)(1)(A), and 1871 of the Social 
Security Act (42 U.S.C. 1302, 1395x(v)(1)(A), and 1395hh).

    2. Section 413.1(a) is amended to revise paragraphs (a)(1) and 
(a)(3) to read as follows:


Sec. 413.1  Introduction.

    (a) Basis, scope, and applicability--(1) Statutory basis--(i) Basic 
provisions. (A) Section 1815 of the Act requires that the Secretary 
make interim payments to providers and periodically determine the 
amount that should be paid under Part A of Medicare to each provider 
for the services it furnishes.
    (B) Section 1814(b) of the Act (for Part A) and section 1833(a) 
(for Part B) provide for payment on the basis of the lesser of a 
provider's reasonable costs or customary charges.
    (C) Section 1861(v) of the Act defines ``reasonable cost''.
    (ii) Additional provisions. (A) Section 1138(b) of the Act 
specifies the conditions for Medicare payment for organ procurement 
costs.
    (B) Section 1814(j) of the Act provides for exceptions to the 
``lower of costs or charges'' provisions.
    (C) Section 1833 (a)(4) and (i)(3) of the Act provide for payment 
of a blended amount for certain surgical services furnished in a 
hospital's outpatient department.
    (D) Section 1833(n) of the Act provides for payment of a blended 
amount for outpatient hospital diagnostic procedures such as radiology.
    (E) Section 1834(c)(1)(C) of the Act establishes the method for 
determining Medicare payment for screening mammograms performed by 
hospitals.
    (F) Section 1834(g) of the Act provides for payment for rural 
primary care hospital (RPCH) outpatient services on the basis of 
prospectively determined amounts.
    (G) Section 1881 of the Act authorizes payment for services 
furnished to ESRD patients.
    (H) Section 1883 of the Act provides for payment for post-hospital 
SNF care furnished by a rural hospital that has swing-bed approval.
    (I) Sections 1886 (a) and (b) of the Act impose a ceiling on the 
rate of increase in hospital inpatient costs.
    (J) Section 1886(h) of the Act provides for payment to a hospital 
for the services of interns and residents in approved teaching programs 
on the basis of a ``per resident'' amount.
* * * * *
    (3) Applicability. The payment principles and related policies set 
forth in this part are binding on HCFA and its fiscal intermediaries, 
on the Provider Reimbursement Review Board, and on the entities listed 
in paragraph (a)(2) of this section.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

    (F) Part 414 is amended as set forth below.
    1. The authority citation for part 414 is revised to read as 
follows:

 
[[Page 50442]]

    Authority: Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

    2. Nomenclature change. In part 414, in the following locations, 
the words ``physicians' services'' are revised to read ``physician 
services'': Secs. 414.1, 414.2 (in the definition of the term, the 
introductory text and paragraph (2)), 414.22, 414.24 (heading and 
paragraph (c)(2)), 414.30, 414.32 (heading and paragraph (b)), 414.40 
(paragraph (b) introductory text), 414.44 (paragraphs (a)(1), (b) 
introductory text, (d), (e), and (f)), and 414.58 (heading and 
paragraph (a)).
    3. The authority citation at the beginning of subpart A is removed.
    4. Section 414.1 is revised to read as follows:


Sec. 414.1  Basis and scope.

    This part implements the indicated provisions of the following 
sections of the Act:

    1833--Rules for payment for most Part B services.
    1834(a) and (h)--Amounts and frequency of payments for durable 
medical equipment and for prosthetic devices and orthotics and 
prosthetics.
    l848--Fee schedule for physician services.
    1881(b)--Rules for payment for services to ESRD beneficiaries.
    1887--Payment of charges for physician services to patients in 
providers.

PART 420--PROGRAM INTEGRITY: MEDICARE

    G. Part 420 is amended as set forth below.
    The authority citation for part 420 is revised to read as follows:

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


Sec. 420.200  [Amended]

    2. In the first sentence of Sec. 420.200, ``1833(e),'' and the 
words ``, and 1866'' are removed, and ``1861'' is revised to read ``and 
1861(v)(1)(i)''.

PART 421--INTERMEDIARIES AND CARRIERS

    H. Part 421 is amended as set forth below.
    1. The authority citation for part 421 is revised to read as 
follows:

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

    2. Sec. 421.1 is amended to redesignate paragraph (b) as paragraph 
(c), revise paragraph (a) and add a new paragraph (b) to read as 
follows:


Sec. 421.1  Basis and scope.

    (a) This part is based on the indicated provisions of the following 
sections of the Act:

    1124--Requirements for disclosure of certain information.
    1816 and 1842--Use of organizations and agencies in making 
Medicare payments to providers and suppliers of services.

    (b) Section 421.118 is also based on 42 U.S.C.1395b-1(a)(1)(F), 
which authorizes demonstration projects involving intermediary 
agreements and carrier contracts
* * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

    I. Part 424 is amended as set forth below.
    1. The authority citation for part 424 is revised to read as 
follows:

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

    2. Sec. 424.1 is amended to revise paragraph (a) to read as 
follows:


Sec. 424.1  Basis and scope.

    (a) Statutory basis. (1) This part is based on the indicated 
provisions of the following sections of the Act:

    1814--Basic conditions for, and limitations on, Medicare 
payments for Part A services.
    1815--Payment to providers for Part A services.
    1835--Procedures for payment to providers for Part B services.
    1842(b)(3)(B)(ii)--Assignment of Part B Medicare claims.
    1842(b)(6)--Payment to entities other than the supplier.
    1848--Payment for physician services.
    1870(e) and (f)--Settlement of claims after death of the 
beneficiary.
    (2) Section 424.444(c) is also based on section 216(j) of the 
Act.

PART 473--RECONSIDERATIONS AND APPEALS

    J. Part 473 is amended as set forth below.
    1. The authority citation for part 473 is revised to read as 
follows:

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


Sec. 473.12  [Amended]

    2. In Sec. 473.12, the following changes are made:
    a. Paragraph (b) is redesignated as paragraph (c).
    b. Paragraph (a) is redesignated as paragraph (b) and revised, and 
a new paragraph (a) is added, to read as set forth below.
    c. In redesignated paragraph (c), ``will review'' is revised to 
read ``reviews''.


Sec. 473.12  Statutory basis.

    (a) Under section 1154 of the Act, a PRO may make an initial 
determination that services furnished or proposed to be furnished are 
not reasonable, necessary, or delivered in the most appropriate 
setting.
    (b) Under section 1155 of the Act, the following rules apply:
    (1) A Medicare beneficiary, a provider, or an attending 
practitioner who is dissatisfied with an initial denial determination 
under paragraph (a) of this section is entitled to a reconsideration by 
the PRO that made that determination.
    (2) The beneficiary is also entitled to the following:
    (i) A hearing by an administrative law judge if $200 or more is 
still in controversy after a reconsidered determination.
    (ii) Judicial review if $2000 or more is still in controversy after 
a final determination by the Department.
* * * * *

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

    K. Part 482 is amended as set forth below.
    1. The authority citation for part 482 is revised to read as 
follows:

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


Sec. 482.1  [Amended]

    2. In Sec. 482.1, the following changes are made:
    a. The heading of paragraph (a) is revised to read ``Statutory 
basis.''.
    b. Paragraph (a)(3) is redesignated as paragraph (a)(5).
    c. New paragraphs (a)(3) and (a)(4) are added to read as set forth 
below.
    d. In paragraph (b), ``subpart S of part 405'' is revised to read 
``subpart A of part 488''.


Sec. 482.1  Basis and scope.

    (a) Statutory basis. * * *
    (3) Sections 1861(k) and 1902(a)(30) of the Act provide that 
hospitals participating in Medicare and Medicaid must have a 
utilization review plan that meets specified requirements.
    (4) Section 1883 of the Act sets forth the requirements for 
hospitals that provide long term care under an agreement with the 
Secretary.
* * * * *

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

    L. Part 483 is amended as set forth below.

[[Page 50443]]

    1. The statutory citation for part 483 is revised to read as 
follows:

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


Sec. 483.1  [Amended]

    2. In Sec. 483.1, the following changes are made:
    a. The heading of paragraph (a) is revised to read ``Statutory 
basis.''.
    b. Paragraph (a)(2) is redesignated as paragraph (a)(3) and a new 
paragraph (a)(2) is added to read as follows:


Sec. 483.1  Basis and scope.

    (a) Statutory basis. * * *
    (2) Section 1861(l) of the Act requires the facility to have in 
effect a transfer agreement with a hospital.


Sec. 483.150  [Amended]

    3. In Sec. 483.150, the following changes are made:
    a. The section heading is revised to read as set forth below.
    b. Paragraphs (a) and (b) are redesignated as paragraphs (b) and 
(c) with the headings added as set forth below.
    c. A new paragraph (a) is added to read as set forth below.


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

    (a) Statutory basis. This subpart is based on sections 1819(b)(5) 
and 1919(b)(5) of the Act, which establish standards for training 
nurse-aides and for evaluating their competency.
    (b) Deemed meeting of requirements. * * *
    (c) Waiver of requirements. * * *

    4. Section 483.200 is revised to read as follows:


Sec. 483.200  Statutory basis.

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

PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES

    M. Part 484 is amended as set forth below.
    1. Section 484.1 is revised to read as follows:


Sec. 484.1  Basis and scope.

    (a) Basis and scope. This part is based on the indicated provisions 
of the following sections of the Act:
    (1) Sections 1861(o) and 1891 establish the conditions that an HHA 
must meet in order to participate in Medicare.
    (2) Section 1861(z) specifies the Institutional planning standards 
that HHAs must meet.
    (b) This part also sets forth additional requirements that are 
considered necessary to ensure the health and safety of patients.

PART 488--SURVEY AND CERTIFICATION PROCEDURES

    N. Part 488 is amended as set forth below.
    l. The authority citation for part 488 is revised to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1895hh).

    2. A new Sec. 488.2 is added to read as follows:


Sec. 488.2  Statutory basis.

    This part is based on the indicated provisions of the following 
sections of the Act:

    1128--Exclusion of entities from participation in Medicare.
    1128A--Civil money penalties.
    1814--Conditions for, and limitations on, payment for Part A 
services.
    1819--Requirements for SNFs.
    1861(f)--Requirements for psychiatric hospitals.
    1861(z)--Institutional planning standards that hospitals and 
SNFs must meet.
    1861(ee)--Discharge planning guidelines for hospitals.
    1864--Use of State survey agencies.
    1865--Effect of accreditation.
    1880--Requirements for hospitals and SNFs of the Indian Health 
Service.
    1883--Requirements for hospitals that provide SNF care.
    1902--Requirements for participation in the Medicaid program.
    1913--Medicaid requirements for hospitals that provide NF care.
    1919--Medicaid requirements for NFs.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance; Program No. 93.773, Medicare Hospital Insurance; Program 
No. 93.774, Medicare Supplementary Medical Insurance)

    Dated: September 15, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-24382 Filed 9-28-95; 8:45 am]
BILLING CODE 4120-01-P