This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

65460

Vol. 66, No. 244

Wednesday, December 19, 2001

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 62

[KS 0145–1145; FRL–7120–3]

Approval and Promulgation of State

Plans for Designated Facilities and

Pollutants; Control of Emissions From

Hospital/Medical/Infectious Waste

Incinerators; State of Kansas

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to approve a

revision to the state of Kansas’ section

111(d) plan for controlling emissions

from existing hospital/medical/

infectious waste incinerators.

In the final rules section of the

Federal Register, EPA is approving the

state’s submittal as a direct final rule

without prior proposal because the

Agency views this as noncontroversial

and anticipates no relevant adverse

comments to this action. A detailed

rationale for the approval is set forth in

the direct final rule. If no relevant

adverse comments are received in

response to this action, no further

activity is contemplated in relation to

this action. If EPA receives relevant

adverse comments, the direct final rule

will be withdrawn and all public

comments received will be addressed in

a subsequent final rule based on this

proposed action. EPA will not institute

a second comment period on this action.

Any parties interested in commenting

on this action should do so at this time.

Please note that if EPA receives adverse

comment on part of this rule and if that

part can be severed from the remainder

of the rule, EPA may adopt as final

those parts of the rule that are not the

subject of an adverse comment.

DATES: Comments on this proposed

action must be received in writing by

January 18, 2002.

ADDRESSES: Comments may be mailed to

Wayne Kaiser, Environmental

Protection Agency, Air Planning and

Development Branch, 901 North 5th

Street, Kansas City, Kansas 66101.

FOR FURTHER INFORMATION CONTACT:

Wayne Kaiser at (913) 551–7603.

SUPPLEMENTARY INFORMATION: See the

information provided in the direct final

rule which is located in the rules

section of the Federal Register.

Dated: December 7, 2001.

James B. Gulliford,

Regional Administrator, Region 7.

[FR Doc. 01–31239 Filed 12–18–01; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

Solicitation of New Safe Harbors and

Special Fraud Alerts

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice of intent to develop

regulations.

SUMMARY: In accordance with section

205 of the Health Insurance Portability

and Accountability Act of 1996, this

annual notice solicits proposals and

recommendations for developing new

and modifying existing safe harbor

provisions under the anti-kickback

statute (section 1128B(b) of the Social

Security Act), as well as developing new

OIG Special Fraud Alerts.

DATES: To assure consideration, public

comments must be delivered to the

address provided below by no later than

5 p.m. on February 19, 2002.

ADDRESSES: Please mail or deliver your

written comments to the following

address: Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–61–N, Room

5246, Cohen Building, 330

Independence Avenue, SW.,

Washington, DC 20201.

We do not accept comments by

facsimile (FAX) transmission. In

commenting, please refer to file code

OIG–61–N. 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 5541 of the

Office of Inspector General at 330

Independence Avenue, SW.,

Washington, DC, on Monday through

Friday of each week from 8:00 a.m. to

4:30 p.m.

FOR FURTHER INFORMATION CONTACT: Joel

Schaer, (202) 619–0089, OIG

Regulations Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. The OIG Safe Harbor Provisions

Section 1128B(b) of the Social

Security Act (the Act) (42 U.S.C. 1320a–

7b(b)) provides criminal penalties for

individuals or entities that knowingly

and willfully offer, pay, solicit or

receive remuneration in order to induce

or reward business reimbursable under

the Federal health care programs. The

offense is classified as a felony and is

punishable by fines of up to $25,000

and imprisonment for up to 5 years. The

OIG may also propose the imposition of

civil money penalties, in accordance

with section 1128A(a)(7) of the Act (42

U.S.C. 1320a–7a), or exclusions from the

Federal health care programs, in

accordance with section 1128(b)(7) of

the Act (42 U.S.C. 1320a–7(b)(7)).

Since the statute on its face is so

broad, concern has been expressed for

many years that some relatively

innocuous commercial arrangements

may be subject to criminal prosecution

or administrative sanction. In response

to the above concern, the Medicare and

Medicaid Patient and Program

Protection Act of 1987, section 14 of

Public Law 100–93, specifically

required the development and

promulgation of regulations, the socalled ‘‘safe harbor’’ provisions,

specifying various payment and

business practices which, although

potentially capable of inducing referrals

of business reimbursable under the

Federal health care programs, would not

be treated as criminal offenses under the

anti-kickback statute and would not

serve as a basis for administrative

sanctions. The OIG safe harbor

provisions have been developed ‘‘to

limit the reach of the statute somewhat

by permitting certain non-abusive

arrangements, while encouraging

beneficial and innocuous arrangements’’

(56 FR 35952, July 29, 1991). Health

care providers and others may

voluntarily seek to comply with these

provisions so that they have the

assurance that their business practices

are not subject to any enforcement

Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Proposed Rules 65461

1The OIG Semiannual Report can be accessed

through the OIG Web site at http://www.dhhs.gov/

oig/semann/index.htm.

action under the anti-kickback statute or

related administrative authorities.

B. OIG Special Fraud Alerts

The OIG has also periodically issued

Special Fraud Alerts to give continuing

guidance to health care providers with

respect to practices the OIG finds

potentially fraudulent or abusive. The

Special Fraud Alerts encourage industry

compliance by giving providers

guidance that can be applied to their

own businesses. The OIG Special Fraud

Alerts are intended for extensive

distribution directly to the health care

provider community, as well as those

charged with administering the Federal

health care programs.

C. Section 205 of Public Law 104–191

Section 205 of Public Law 104–191

requires the Department to develop and

publish an annual notice in the Federal

Register formally soliciting proposals

for modifying existing safe harbors to

the anti-kickback statute and for

developing new safe harbors and

Special Fraud Alerts.

In developing safe harbors for a

criminal statute, the OIG is required to

engage in a thorough review of the range

of factual circumstances that may fall

within the proposed safe harbor subject

area so as to uncover potential

opportunities for fraud and abuse. Only

then can the OIG determine, in

consultation with the Department of

Justice, whether it can effectively

develop regulatory limitations and

controls that will permit beneficial and

innocuous arrangements within a

subject area while, at the same time,

protecting the Federal health care

programs and their beneficiaries from

abusive practices.

II. Solicitation of Additional New

Recommendations and Proposals

In accordance with the requirements

of section 205 of Public Law 104–191,

the OIG last published a Federal

Register solicitation notice for

developing new safe harbors and

Special Fraud Alerts on December 14,

2000 (65 FR 78124). As required under

section 205, a status report of the public

comments received in response to that

notice is set forth in Appendix F to the

OIG’s Semiannual Report covering the

period April 1, 2001 through September,

30, 2001.1 The OIG is not seeking

additional public comment on the

proposals listed in Appendix F at this

time. Rather, this notice seeks

additional recommendations regarding

the development of proposed or

modified safe harbor regulations and

new Special Fraud Alerts beyond those

summarized in Appendix F to the OIG

Semiannual Report referenced above.

Criteria for Modifying and Establishing

Safe Harbor Provisions

In accordance with section 205, we

will consider a number of factors in

reviewing proposals for new or

modified safe harbor provisions, such as

the extent to which the proposals would

effect an increase or decrease in—

• Access to health care services;

• The quality of care services;

• Patient freedom of choice among

health care providers;

• Competition among health care

providers;

• The cost to Federal health care

programs;

• The potential overutilization of the

health care services; and

• The ability of health care facilities

to provide services in medically

underserved areas or to medically

underserved populations.

In addition, we will also take into

consideration other factors, including,

for example, the existence (or

nonexistence) of any potential financial

benefit to health care professionals or

providers that may vary based on their

decisions whether to (1) order a health

care item or service, or (2) arrange for

a referral of health care items or services

to a particular practitioner or provider.

Criteria for Developing Special Fraud

Alerts

In determining whether to issue

additional Special Fraud Alerts, we will

also consider whether, and to what

extent, the practices that would be

identified in a new Special Fraud Alert

may result in any of the consequences

set forth above, as well as the volume

and frequency of the conduct that

would be identified in the Special Fraud

Alerts.

A detailed explanation of

justifications for, or empirical data

supporting, a suggestion for a safe

harbor or Special Fraud Alert would be

helpful and should, if possible, be

included in any response to this

solicitation.

Dated: December 4, 2001.

Janet Rehnquist,

Inspector General.

[FR Doc. 01–31207 Filed 12–18–01; 8:45 am]

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