[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Rules and Regulations]
[Pages 50446-50448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24384]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 485 and 486

[BPD-836-FC]


Medicare Program--Providers and Suppliers of Specialized 
Services: Technical Amendments

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This rule makes editorial and clarifying changes in the 
regulations that pertain to providers and suppliers of specialized 
services. It also adds a new subpart A to those that pertain to 
suppliers. These changes are purely technical and have no substantive 
effect on the Medicare program.

DATES: Effective date: This rule is effective as of September 27, 1991. 
Comment date: We will consider comments received by November 28, 1995.

ADDRESSES: Please mail original and 3 copies of your comments to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: BPD-836-FC, P.O. Box 26676, 
Baltimore, MD 21207.
    If you prefer, you may deliver original and 3 copies of your 
comments to either of the following addresses:

Room 309-G, 200 Independence Avenue, SW, Washington, DC 20201
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850

    Due to staffing and resource limitations, we cannot accept comments 
by facsimile (FAX) transmission. In commenting, please refer to file 
code BPD-836-FC.
    Written comments received timely will be available for public 
inspection as they are received, generally beginning approximately 
three weeks after publication of the document, in room 309G of the 
Department's offices at 200 Independence Avenue, SW, Washington, DC, 
Monday through Friday, 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: On January 9, 1995, we published a technical 
regulation identified as BPD-798-FC (at 60 FR 2325) to reorganize the 
HCFA regulations that pertain to specialized services. The rules that 
pertain to specialized services furnished by providers were 
redesignated under part 485, and the rules that pertain to specialized 
services furnished by suppliers were redesignated under a new part 486. 
As explained in the preamble to BPD-798-FC, regulations on organ 
procurement organizations (OPOs) and on screening mammographies were 
not relocated to part 486 because they were in the process of 
undergoing substantive changes.
    No comments were received on the January 9 publication. However, 
for reasons indicated below, we need to make changes in parts 485 and 
486.
    The final rules on OPOs have been delayed. To ensure that in the 
October 1, 1995 edition of the Code of Federal Regulations the current 
rules on OPOs (which are not providers) appear in the appropriate part, 
we are redesignating them as subpart G of part 486.
    The rules on mammographies have been redesignated under Sec. 410.34 
of the HCFA regulations and that section specifies that certain Food 
and Drug Administration rules also apply.

    We are adding a new ``Basis and scope'' section to part 486. One 
purpose of the new section is to inform the reader of where the 
conditions for coverage for other specialized services furnished by 
suppliers are to be found.

    This rule also--

     Clarifies and simplifies 3 definitions in part 485;
     Provides uniform heading format for all sections of 
redesignated subpart G and revises some of those headings; and
     Corrects internal cross-references as required by the 
redesignations.

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.).

Waiver of Proposed Rulemaking and Delayed Effective Date

    The changes made by this rule are purely technical and editorial 
and have no substantive impact. 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 changes be effective as of October 1, 1995, so that they 
will appear 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.

Response to Comments

    Although this is a final rule, we will consider timely comments 
from anyone who believes that, in making the technical and editorial 
changes, we have unintentionally changed the substance of the 
regulations. Although we cannot respond to comments individually, if we 
revise this rule as a result of comments, we will discuss all timely 
comments in the preamble to the revised rule.

Regulatory Impact 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 governmental jurisdiction (such as a county, city, or 
township) with a population of less than 50,000. We also 

[[Page 50447]]
consider all providers and suppliers to be small entities. For purposes 
of section 1102(b) of the Act, we define 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 this rule (which makes only 
technical and editorial changes) will not have a significant economic 
impact on a substantial number of small entities nor 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 485

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

42 CFR Part 486

    Health professionals, Medicare, Organ procurement, X-rays.

    42 CFR Chapter IV is amended as set forth below.

PART 485--CONDITIONS OF PARTICIPATION; PROVIDERS OF SPECIALIZED 
SERVICES

    A. Part 485 is amended as set forth below.
    1. The authority citation for part 485 continues to read as 
follows:

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


Secs. 485.301 through 485.309 and 485.311  [Redesignated]

    2. Subpart D of part 485, consisting of Secs. 485.301 through 
485.309 and 485.311, is redesignated as subpart G of part 486 in 
accordance with the following redesignation table:

------------------------------------------------------------------------
                                                            New section 
           Old section (subpart D of part 485)             (subpart G of
                                                             part 486)  
------------------------------------------------------------------------
485.301.................................................         486.301
485.302.................................................         486.302
485.303.................................................         486.304
485.304.................................................         486.306
485.305.................................................         486.308
485.306.................................................         486.310
485.307.................................................         486.314
485.308.................................................         486.316
485.309.................................................         486.318
485.311.................................................         486.325
------------------------------------------------------------------------

    3. Section 485.703 is amended to revise the definitions of 
``clinic'', ``rehabilitation agency'', and ``supervision'', to read as 
follows:


Sec. 485.703  Definitions.

    Clinic. A facility that is established primarily to furnish 
outpatient physician services and that meets the following tests of 
physician involvement:
    (1) The medical services are furnished by a group of three or more 
physicians practicing medicine together.
    (2) A physician is present during all hours of operation of the 
clinic to furnish medical services, as distinguished from purely 
administrative services.
* * * * *
    Rehabilitation agency. An agency that--
    (1) Provides an integrated multidisciplinary rehabilitation program 
designed to upgrade the physical functioning of handicapped disabled 
individuals by bringing specialized rehabilitation staff together to 
perform as a team; and
    (2) Provides at least the following services:
    (i) Physical therapy or speech-language pathology services.
    (ii) Social or vocational adjustment services.
    Supervision. Authoritative procedural guidance that is for the 
accomplishment of a function or activity and that--
    (1) Includes initial direction and periodic observation of the 
actual performance of the function or activity; and
    (2) Is furnished by a qualified person--
    (i) Whose sphere of competence encompasses the particular function 
or activity; and
    (ii) Who (unless otherwise provided in this subpart) is on the 
premises if the person performing the function or activity does not 
meet the assistant-level practitioner qualifications specified in 
Sec. 485.705.
    4. In the following sections, the section heading is amended to 
change the dash to a colon and to capitalize the first word after the 
colon:
    Secs. 485.709, 485.713, 485.717, 485,719, and 485.725.

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

    B. Part 486 is amended as set forth below.
    1. The heading of part 486 is revised to read as set forth above.
    2. The authority citation for part 486 continues to read as 
follows:

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

    3. A new subpart A is added, to read as follows:

Subpart A--General Provisions

Sec.
486.1  Basis and scope.


Sec. 486.1  Basis and scope.

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

    1138(b)--for coverage of organ procurement services.
    1861(p)--for coverage of outpatient physical therapy services 
furnished by physical therapists in independent practice.
    1861(s) (3), (15), and (17)--for coverage of portable X-ray 
services.

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


Sec. 486.110  [Amended]

    4. In Sec. 486.110(b), ``outlined in Sec. 405.1415.'' is revised to 
read ``outlined in Sec. 486.108.''.
    5. Subparts E and F are added and reserved.
    6. In newly designated subpart G, the headings of the specified 
sections are revised to read as follows: 

[[Page 50448]]



Sec. 486.304  General requirements.


Sec. 486.306  Qualifications for designation as an OPO.


Sec. 486.308  Condition: Participation in organ procurement and 
transplantation network.


Sec. 486.310  Condition: Adherence to performance standards.


Sec. 486.314  Effect of failure to meet requirements.


Sec. 486.325  Termination of agreement with HCFA.

    7. In newly designated subpart G, all references to the section 
numbers listed in the following left-hand column are corrected to read 
as shown in the right-hand column:

------------------------------------------------------------------------
                             Sec.                                 Sec.  
------------------------------------------------------------------------
485.303......................................................    486.304
485.304......................................................    486.306
405.305......................................................    486.308
485.306......................................................    486.310
485.309......................................................    486.318
------------------------------------------------------------------------

    The references that are being corrected appear in the following 
sections: Secs. 486.302, 486.304(b)(3) and (b)(5) through (b)(7), 
486.314, 486.316 introductory text, and 486.318(b).

(Catalog of Federal Domestic Assistance Program No. 93-773, 
Medicare--Hospital Insurance, and No. 93-774, Medicare--
Supplementary Medical Insurance)

    Dated: September 11, 1995
Bruce C. Vladeck
Administrator, Health Care Financing Administration.
[FR Doc. 95-24384 Filed 9-28-95; 8:45 am]
BILLING CODE 4120-01-P