[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)]
[Rules and Regulations]
[Pages 63438-63440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30064]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 411

[BPD-850-F]


Medicare Program; Physician Self-Referral Regulations: Change in 
Date for Submission of Group Attestation Statement

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

ACTION: Final rule--Technical amendment.

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SUMMARY: This final rule changes (delays) the date by which a group of 

[[Page 63439]]
physicians that wishes to be identified as a group practice for 
purposes of the physician self-referral regulations (42 CFR 411.350 
through 411.361) must file a statement attesting that it meets certain 
specified conditions.

DATES: These regulations are effective on December 11, 1995.

FOR FURTHER INFORMATION CONTACT: Patricia Snyder (attestation issues) 
(410) 786-5991, Betty Burrier (other physician referral issues) (410) 
786-4649.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 14, 1995, we published, at 60 FR 41914, a final rule with 
comment period entitled, ``Medicare program; Physician Financial 
Relationships With, and Referrals to, Health Care Entities That Furnish 
Clinical Laboratory Services and Financial Relationship Reporting 
Requirements.'' That rule specified that, if a physician or a member of 
a physician's immediate family has a financial relationship with an 
entity, the physician may not make referrals to the entity for the 
furnishing of clinical laboratory services under the Medicare program 
except under specified circumstances. Under the rule, being designated 
as a group practice may enable a group of physicians to meet the 
conditions that would qualify it for an exception to the prohibition on 
referrals. Specifically, the rule required, at Sec. 411.360 (a) and 
(b), that a group of physicians that intends to be identified as a 
group practice (as defined at Sec. 411.351) submit a written statement 
to attest that, during the most recent 12-month period (calendar year, 
fiscal year, or immediately preceding 12-month period), 75 percent of 
the total patient care services of group practice members was furnished 
through the group, was billed under a billing number assigned to the 
group, and the amounts so received were treated as receipts of the 
group. In the case of a newly formed group practice, the group would 
submit a statement to attest that during the next calendar year, fiscal 
year, or 12-month period, it expects to meet the 75-percent standard. 
The rule further required, at Sec. 411.360(e), that the attestation be 
submitted to the appropriate Medicare carrier by December 12, 1995.

II. Provisions of This Rule

    This rule changes the above submittal date to require that the 
attestation statement be submitted no later than 60 days after receipt 
of instructions from the carrier.
    We have been in the process of developing a method for groups to 
provide us with their attestation statements. However, we have come to 
realize that those individuals who would be completing the attestation 
statement need to be offered more guidance than we had originally 
anticipated providing in the attestation instructions. The attestation 
instructions will not be available early enough to give the respondents 
sufficient time to submit the statement by the deadline stated in the 
regulations. Therefore, this final rule revises Sec. 411.360(e) to 
require that the attestation be submitted no later than 60 days after 
receipt of the attestation instructions from the carrier. In the 
interim, a group of physicians can regard itself as a group practice if 
it believes it meets the definition of group practice that was 
incorporated in our regulations, at Sec. 411.351, by the August 14 
rule.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, agencies are required to 
provide a 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     Whether the information collection is necessary and useful 
to carry out the proper functions of the agency;
     The accuracy of the agency's estimate of the information 
collection burden;
     The quality, utility, and clarity of the information to be 
collected; and
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques. Therefore, we are soliciting public comment on each of 
these issues for the information collection requirement discussed 
below.
    Section 411.360 contains a requirement concerning those groups of 
physicians attempting to be identified as a ``group practice.'' It 
specifies that the group must attest that, in the aggregate, 75 percent 
of total patient care services furnished by all physician members are 
(or, in the case of a newly formed group, are expected to be) furnished 
through the group and billed under a billing number assigned to the 
group. This information collection requirement was established by the 
August 14, 1995 rule discussed earlier. As stated in the August 14, 
1995 rule, public reporting burden for this collection of information 
is estimated to be 1 hour per response. Organizations and individuals 
were given an opportunity to comment on the information collection 
requirements at the time the August 14 rule was published. However, 
because this rule changes the date by which the attestation must be 
submitted, we are again soliciting public comment on this requirement 
and providing the 60-day notice. As also stated in the August 14 rule, 
a document will be published in the Federal Register after Office of 
Management and Budget approval is obtained.
    Organizations and individuals desiring to submit comments on these 
information collection and recordkeeping requirements should mail 
written comments (1 original and 3 copies) to the following address: 
Health Care Financing Administration, Department of Health and Human 
Services, Attention: BPD-850-F, P.O. Box 26688, Baltimore, MD 21207.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses: Room 309-G, Hubert H. 
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, 
or Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21224-1850.

IV. Waiver of Proposed Rulemaking and Delay in Effective Date

    As required by the Administrative Procedure Act, we generally 
provide notice and opportunity for comment on regulations and provide 
that final rules are not effective until 30 days after the date of 
publication unless we can find good cause for waiving the notice-and-
comment procedure and delayed effective date as impracticable, 
unnecessary, or contrary to the public interest.
    Unless the requirement at Sec. 411.360(e) is revised before 
December 12, 1995, the regulations would contain a requirement that, 
through no fault of their own, groups of physicians would be unable to 
meet. Therefore, we find good cause to waive the notice-and-comment 
procedure as being contrary to the public interest. We also find good 
cause to waive the delay in effective date.

V. Regulatory Impact Statement

    Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
through 612), we prepare a regulatory flexibility analysis unless we 
certify that a rule will not have a significant economic impact on a 
substantial number of small entities. For purposes of the RFA, all 
physicians are considered to be small entities. 

[[Page 63440]]

    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. Such 
an analysis must conform to the provisions of section 604 of the RFA. 
For purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 50 beds.
    This rule merely makes a technical amendment to delay the due date 
for the submission, by a group of physicians that wishes to be 
identified as a ``group practice,'' of a statement attesting that it 
meets certain conditions. For this reason, we are not preparing 
analyses for either the RFA or section 1102(b) of the Act because we 
have determined, and we certify, that this rule will not have a 
significant economic impact on a substantial number of small entities 
or a significant impact on the operations of a substantial number of 
small rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 411

    Kidney diseases, Medicare, Physician referral, Reporting and 
recordkeeping requirements.

    42 CFR part 411 is amended as set forth below:

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATION ON MEDICARE 
PAYMENT

    1. The authority citation for part 411 continues to read as 
follows:

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

    2. In Sec. 411.360, paragraph (e) is revised to read as follows:


Sec. 411.360  Group practice attestation.

* * * * *
    (e) A group that intends to meet the definition of a group practice 
in order to qualify for an exception described in Secs. 411.355 through 
411.357, must submit the attestation required by paragraph (a) or 
paragraph (b)(1) of this section, as applicable, to its carrier no 
later than 60 days after receipt of the attestation instructions from 
its carrier.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: November 21, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.

    Dated: November 29, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-30064 Filed 12-8-95; 8:45 am]
BILLING CODE 4120-01-P