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

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

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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.

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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