63438 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

on canola will remain regionally

restricted and time-limited because of a

concern for avian toxicity. The use is

extended for the 1996 growing season

only. The Agency expects to register an

alternative chemical in late 1995 for

early season control of the flea beetle.

This may be available in limited

quantities for the 1996 growing season,

and fully available thereafter.

The Interregional Research Project No.

4 (IR-4) plans to submit a petition for a

permanent tolerance for carbofuran on

canola in late 1995 or early 1996.

However, because of the known hazard

of carbofuran to birds and wildlife, EPA

will not establish a permanent tolerance

until the Agency has fully evaluated

risks to wildlife.

The data submitted on the proposal

and other relevant material have been

evaluated and discussed in the

proposed rule of November 8, 1994 (59

FR 55605). Based on that data and

information considered, the Agency

concludes that extension of the timelimited tolerance will continue to

protect the public health. Therefore, the

time-limited tolerance is extended for

an additional 1-year period.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

EPA has established a record for this

rulemaking under docket number [OPP300406] (including any comments and

data submitted electronically). A public

version of this record, including

printed, paper versions of electronic

comments, which does not include any

information claimed as CBI, is available

for inspection from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall 1B2,

1921 Jefferson Davis Highway,

Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to a rule (1) having an annual effect

on the economy of $100 million or

more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities (also known as

‘‘economically significant’’); (2) creating

serious inconsistency or otherwise

interfering with an action taken or

planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 30, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

§ 180.254 [Amended]

2. In § 180.254 Carbofuran; tolerances

for residues, by amending paragraph (c)

in the introductory text by changing the

date ‘‘February 22, 1997’’ to read

‘‘February 22, 1998’’.

[FR Doc. 95–30115 Filed 12–6–95; 4:03 pm]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 411

[BPD–850–F]

Medicare Program; Physician SelfReferral Regulations: Change in Date

for Submission of Group Attestation

Statement

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Final rule—Technical

amendment.

SUMMARY: This final rule changes

(delays) the date by which a group of
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 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 § 411.360 (a) and (b), that a group of

physicians that intends to be identified

as a group practice (as defined at

§ 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

§ 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 § 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 § 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-andcomment procedure and delayed

effective date as impracticable,

unnecessary, or contrary to the public

interest.

Unless the requirement at § 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-andcomment 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.
63440 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

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 § 411.360, paragraph (e) is

revised to read as follows:

§ 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

§§ 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

42 CFR Part 424

[BPD–838–FC]

RIN 0938–AH19

Medicare Program; Additional Supplier

Standards

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Final rule with comment.

SUMMARY: This final rule with comment

period conforms our regulations to

changes made to section 1834 of the

Social Security Act (the Act) by section

131 of the Social Security Act

Amendments of 1994. Section 1834(j) of

the Act requires that suppliers meet

additional standards related to

compliance with State and Federal

licensure requirements, maintaining a

physical facility on an appropriate site,

and proof of appropriate liability

insurance. This final rule retains

existing regulatory standards and

incorporates the three additional

standards specifically cited from the

statute.

DATES: Effective Date: This rule is

effective January 1, 1996.

Comments: Comments will be

considered if we receive them at the

appropriate address, as provided below,

no later than 5 p.m. on February 9,

1996.

ADDRESSES: Mail written comments (1

original and 3 copies) to the following

address: Health Care Financing

Administration, Department of Health

and Human Services, Attention: BPD–

838–FC, P.O. Box 26676, 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 21244–

1850.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

BPD–838–FC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after publication of a document,

in Room 309–G of the Department’s

offices at 200 Independence Avenue,

SW, Washington, DC, on Monday

through Friday of each week from 8:30

a.m. to 5 p.m. (phone: (202) 690–7890).

For comments that relate to

information collection requirements,

mail a copy of comments to: Office of

Information and Regulatory Affairs,

Office of Management and Budget,

Room 10235, New Executive Office

Building, Washington, DC 20503, Attn:

Allison Herron Eydt, HCFA Desk

Officer.

FOR FURTHER INFORMATION CONTACT:

Larry Bonander, (410) 786–4479.

SUPPLEMENTARY INFORMATION:

I. Background

A. General

The Medicare Part B program is a

voluntary program that pays all or part

of the costs for physicians’ services,

outpatient hospital services, certain

home health services, services furnished

by rural health clinics, ambulatory

surgical centers, and comprehensive

outpatient rehabilitation facilities, and

certain other medical and hospital

health services not covered by Medicare

Part A.

Medicare services are furnished by

two types of entities, that is, providers

and suppliers. The term ‘‘provider’’ as

defined in our regulations at 42 CFR

400.202, means a hospital, a rural

primary care hospital, a skilled nursing

facility, a comprehensive outpatient

rehabilitation facility, a home health

agency, or a hospice that has in effect an

agreement to participate in Medicare. A

clinic, a rehabilitation agency, or a

public health agency that has a similar

agreement to furnish outpatient physical

therapy or speech pathology services, or

a community mental health center with

a similar agreement to furnish partial

hospitalization services, is also

considered a provider (see sections

1861(u) and 1866(e) of the Social

Security Act (the Act)).

In general, suppliers are individuals

or entities that furnish certain types of

medical and other health services under

part B. There are different definitions of

the term supplier and specific

regulations governing different types of

suppliers. Durable medical equipment,

prosthetics, orthotics, and supplies

(DMEPOS) encompasses the types of

items included in the definition of

‘‘medical equipment and supplies’’

found at section 1834(j)(5) of the Act. In