71766 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Proposed Rules 

VII. Statutory and Executive Order 

Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this proposed 

action is not a ‘‘significant regulatory 

action’’ and therefore is not subject to 

review by the Office of Management and 

Budget. For this reason, this action is 

also not subject to Executive Order 

13211, ‘‘Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). This proposed action merely 

proposes to approve state law as 

meeting Federal requirements and 

imposes no additional requirements 

beyond those imposed by state law. 

Accordingly, the Administrator certifies 

that this proposed rule will not have a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.). Because this rule 

proposes to approve pre-existing 

requirements under state law and does 

not impose any additional enforceable 

duty beyond that required by state law, 

it does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4).

This proposed rule also does not have 

tribal implications because it will not 

have a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes, 

as specified by Executive Order 13175 

(65 FR 67249, November 9, 2000). This 

action also does not have Federalism 

implications because it does not have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

proposes to approve a state rule 

implementing a Federal standard, and 

does not alter the relationship or the 

distribution of power and 

responsibilities established in the Act. 

This proposed rule also is not subject to 

Executive Order 13045 ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant. 

In reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Act. In this context, in the absence 

of a prior existing requirement for the 

state to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a SIP submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a SIP submission, 

to use VCS in place of a SIP submission 

that otherwise satisfies the provisions of 

the Act. Thus, the requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) do not 

apply. This proposed rule does not 

impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds.

Authority: 42 U.S.C. 7401—7671q.

Dated: November 30, 2004. 

George Pavlou, 

Acting Regional Administrator, Region 2.

[FR Doc. 04–27170 Filed 12–9–04; 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 (HIPAA) of 

1996, this annual notice solicits 

proposals and recommendations for 

developing new and modifying existing 

safe harbor provisions under the Federal 

and State health care programs’ antikickback 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 8, 2005.

ADDRESSES: Please mail or deliver your 

written comments to the following 

address: Office of Inspector General, 

Department of Health and Human 

Services, Attention: OIG–91–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–91–N. Comments received timely 

will be available for public inspection as 

they are received, generally beginning 

approximately three 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 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 impose civil money 

penalties, in accordance with section 

1128A(a)(7) of the Act (42 U.S.C. 1320a–

7a(a)(7)), or exclusion 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’’

Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Proposed Rules 71767

1The OIG Semiannual Report can be accessed 

through the OIG Web site at http://oig.hhs.gov/

publications/semiannual.html.

(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 

will not be subject to any enforcement 

action under the anti-kickback statute or 

related administrative authorities. 

To date, OIG has developed and 

codified in 42 CFR 1001.952 a total of 

22 final safe harbors that describe 

practices that are sheltered from 

liability. 

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 OIG finds 

potentially fraudulent or abusive. The 

Special Fraud Alerts encourage industry 

compliance by giving providers 

guidance that can be applied to their 

own practices. The OIG Special Fraud 

Alerts are intended for extensive 

distribution directly to the health care 

provider community, as well as to those 

charged with administering the Federal 

health care programs. 

In developing these Special Fraud 

Alerts, OIG has relied on a number of 

sources and has consulted directly with 

experts in the subject field, including 

those within OIG, other agencies of the 

Department, other Federal and State 

agencies, and those in the health care 

industry. To date, OIG has issued 12 

individual Special Fraud Alerts. 

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, 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 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, 

OIG last published a Federal Register

solicitation notice for developing new 

safe harbors and Special Fraud Alerts on 

December 12, 2003 (68 FR 69366). As 

required under section 205, a status 

report of the public comments received 

in response to that notice is set forth in 

Appendix G to the OIG’s Semiannual 

Report covering the period April 1, 2004 

through September, 30, 2004.1 The OIG 

is not seeking additional public 

comment on the proposals listed in 

Appendix G 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 G to the OIG Semiannual 

Report referenced above.

Criteria for Modifying and Establishing 

Safe Harbor Provisions 

In accordance with section 205 of 

HIPAA, 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 affect an increase or decrease 

in—

• Access to health care services; 

• The quality of 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 take into account 

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 

Alert. 

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: November 24, 2004. 

Daniel R. Levinson, 

Acting Inspector General.

[FR Doc. 04–27117 Filed 12–9–04; 8:45 am] 

BILLING CODE 4150–04–P

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

49 CFR Part 1507

[Docket No. TSA–2004–19845] 

RIN 1652–AA34

Privacy Act of 1974: Implementation of 

Exemptions

AGENCY: Transportation Security 

Administration (TSA), DHS.

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: TSA proposes to exempt 

Transportation Security Intelligence 

Service (TSIS) Operations Files (DHS/

TSA 011) from several provisions of the 

Privacy Act; to add 5 U.S.C. 552a(k)(1) 

as an authority to exempt the Personnel 

Background Investigation File System 

(DHS/TSA 004) from the provisions 

previously claimed for that system; and 

to add 5 U.S.C. 552a(j)(2) as an authority 

to exempt the Transportation Security 

Enforcement Record System (DHS/TSA 

001) and the Internal Investigation 

Record System (DHS/TSA 005) from the 

provisions previously claimed for those 

two systems, to now include subsection 

(e)(3). Public comment is invited.

DATES: Submit comments by January 10, 

2005.

ADDRESSES: You must identify the TSA 

docket number when you submit 

comments to this rulemaking, using any 

one of the following methods: 

Comments Filed Electronically: You 

may submit comments through the 

docket Web site at http://dms.dot.gov.

Please be aware that anyone is able to 

search the electronic form of all 

comments received into any of our 

dockets by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.).