[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)
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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
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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
