65046 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15, and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)),

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this 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.). The State submittal

which is the subject of this rule is based

upon counterpart Federal regulations for

which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the department relied upon the

data and assumptions for the

counterpart Federal regulations.

Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.

List of Subjects in 30 CFR Part 917

Intergovernmental relations, Surface

mining, Underground mining.

Dated: December 2, 1997.

Michael K. Robinson,

Acting Regional Director, Appalachian

Regional Coordinating Center.

[FR Doc. 97–32222 Filed 12–9–97; 8:45 am]

BILLING CODE 4310–05–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[WI74–01–7303; FRL–5929–8]

Approval and Promulgation of

Implementation Plans; Wisconsin

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed rulemaking.

SUMMARY: The purpose of this action is

to propose approval of the State of

Wisconsin’s Prevention of Significant

Deterioration (PSD) rules, Natural

Resources (NR) 405.01 through NR

405.17, as a revision to the Wisconsin

State Implementation Plan (SIP). The

State developed rules as Wisconsin’s

plan to prevent significant deterioration

of air quality in areas designated as

unclassifiable or attainment of the

National Ambient Air Quality Standards

(NAAQS) and to satisfy the

requirements of part C of the Clean Air

Act (Act). EPA is approving these rules

because they meet EPA’s regulation

governing State PSD programs. In

addition to the PSD rules, Wisconsin

has submitted rules as a revision to the

SIP to establish breathable particulates

(PM–10) as a basis for the determination

of particle concentrations for permitting

purposes under the PSD program and,

therefore, tie the new source permit

evaluations directly to human health

standards. Finally, Wisconsin submitted

as a revision to the SIP changes of a

‘‘clean-up’’ nature, intended to correct

errors in content or style, to improve

consistency, or clarify existing policy

and procedures.

DATES: Comments on this revision and

on the proposed EPA action must be

received by January 9, 1998. Comments

received in response to EPA’s January 4,

1994 proposed disapproval of NR 405

will, if still applicable, be responded to

at the time of EPA’s final rulemaking on

this rule and need not be resubmitted.

ADDRESSES: Comments should be

submitted to Carlton Nash, EPA Region

5, 77 West Jackson Boulevard, AR–18J,

Chicago, Illinois, 60604. Copies of the

State’s submittal and other supporting

information used in developing the

proposed approval are available for

inspection during normal business

hours at the above Region 5 address.

Please contact Constantine Blathras at

(312) 886–0671 to arrange a time if

inspection of these materials is desired.

Copies of the submittal are also

located at the Bureau of Air

Management, Wisconsin Department of

Natural Resources, 101 South Webster

Street, P.O. Box 7921, Madison,

Wisconsin 53707.

FOR FURTHER INFORMATION CONTACT:

Constantine Blathras, AR–18J, 77 West

Jackson Boulevard, Chicago, Illinois,

60604, (312) 886–0671.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

The 1977 Amendments to the Act

added part C to Title I, which required

implementation of a PSD program. On

June 19, 1978, EPA promulgated a PSD

program to meet the requirements of

part C, 50 CFR 52.21, which contains

the procedures and requirements which

EPA follows when it carries out the

mandates of part C itself. These Section

52.21 requirements were then

promulgated into those State SIPs where

a State did not have an approvable plan

in place. Section 52.21 provides that its

requirements and authorities, or part

thereof, can be delegated to the State

and local air programs if EPA

determines they have the ability and

authority to carry out its mandates.

On June 19, 1978, (43 FR 26410), EPA

promulgated the Federal PSD program,

40 CFR 52.21 (b–v), into the Wisconsin

SIP at 40 CFR 52.2581 because

Wisconsin had not submitted an

approvable PSD program. On August 19,

1980, EPA gave Wisconsin partial

delegation to run the Federal PSD

program and on November 13, 1987,

gave Wisconsin full delegation of the

program, except for sources within the

exterior boundaries of a Tribal

reservation.

Section 301(d) of the Act authorizes

the Administrator to determine which

Act authorities are appropriate for

Tribes to administer within the exterior

boundaries of its reservations and to

promulgate rules as to how Tribes can

assume these authorities. These rules

were proposed, but have yet to be

promulgated. EPA recognizes that a

Tribe will upon promulgation generally

have inherent sovereign authority over

air resources within the exterior

boundaries of its reservation, if

requested and approved. Until such

time, EPA will continue to implement

these programs within the exterior
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules 65047

boundaries of Indian reservations.

Therefore, EPA did not delegate and is

proposing to not approve Wisconsin’s

PSD or PM–10 rules for application with

the exterior boundaries of Tribal

reservations.

On March 16, 1987, the Wisconsin

Department of Natural Resources

(WDNR) requested the Regional

Administrator to include Chapter NR

405 of the Wisconsin Administrative

Code as part of the SIP to meet the

requirements of part C of the Act and as

a replacement for EPA’s delegated

program (40 CFR 52.2581). Rule NR 405

deals exclusively with PSD permitting

requirements. On January 4, 1994 (59 FR

278), EPA proposed to disapprove

Wisconsin’s PSD SIP revision, NR

405.01 through NR 405.17. The

deficiencies in the proposal were

addressed by the WDNR in comments

on March 8, 1994, and, to avoid having

the SIP revision formally disapproved,

the WDNR withdrew the original

submittal.

On November 6, 1996, the WDNR

submitted a request for approval of its

PSD program, as revised. More

specifically, this submittal addresses the

deficiencies listed in the January 4,

1994, Federal Register document

proposing to disapprove the State of

Wisconsin’s PSD rules as a revision to

the Wisconsin SIP. On December 18,

1996, EPA sent a letter to the WDNR

deeming the revised submittal complete

and initiating the processing of the

request. The following analysis

addresses the review of the submittal

with respect to the requirements found

in EPA’s regulation governing State PSD

programs (40 CFR 51.166).

II. Approvability Analysis

Wisconsin NR 405 deals exclusively

with PSD permitting requirements. EPA

evaluated NR 405 by comparing each

section of the rule to the appropriate

paragraph of 40 CFR 51.166 (formerly 40

CFR 51.24). Listed below are the

deficiencies formerly found and raised

in the January 4, 1994, Federal Register

document and how the WDNR

addressed those concerns. All other

portions of NR 405 were found

previously to be approvable and remain

so.

A. NSPS and NESHAP

1994 Deficiency: The Federal PSD

definitions at 40 CFR 51.166 pertaining

to (1) Best Available Control

Technology’’ (BACT), (2) ‘‘Allowable

emissions,’’ (3) ‘‘Federally enforceable,’’

and (4) the control technology review

requirements make reference to

applicable standards and standards of

performance under 40 CFR part 60

(NSPS) and 40 CFR part 61 (NESHAPS),

respectively. In the comparable

provisions of the State rule, the State

referred to other NR 400 series chapters,

i.e., NR 400, 445 to 499, and 400 to 499

of the State code. Although the State

may have intended that these chapters

approximate the requirements of 40 CFR

part 60 and 40 CFR part 61, Wisconsin’s

NSPS and NESHAP regulations are not

federally enforceable and may, in

certain circumstances, differ

significantly from the parts 60 and 61

requirements in the Federal PSD

requirements. Furthermore, the

references to parts 60 and 61

requirements in the Federal PSD

requirements for BACT and control

technology review (sections 51.166

(b)(12) and 51.166 (j)(1), respectively)

set minimum emissions requirements.

Because under the State rules, the State

could set less stringent NSPS and

NESHAP emission limits than the

Federal standards, or not set any limits

at all, the State PSD provisions which

were dependent upon the requirements

of Chapter NR 400 and Chapters NR 445

to 499 were not approvable. Section 116

of the Act prohibits States from

adopting standards and limitations that

are less stringent than Federal standards

and limitations.

WDNR Response: Wisconsin changed

the definitions of ‘‘allowable emissions’’

(NR 405.02(2), Wis. Adm. Code),

‘‘BACT’’ (NR 405.02(7), and ‘‘federally

enforceable’’ (NR 400.02(39M).

Wisconsin also changed section NR

405.08, to reflect the requirement that

limits set in a PSD permit can not be

less stringent than an applicable

requirement in 40 CFR parts 60, 61, or

63, in addition to the requirements

contained in the States rules.

EPA Analysis: WDNR has adequately

addressed the deficiency.

B. Stack Height

1994 Deficiency: The provisions in 40

CFR part 51, Subpart I—‘‘Revision of

New Sources and Modifications’’ set

forth both general and specific

requirements for permitting PSD

sources, including definitions. In order

for the State to implement the stack

height provision in accordance with 40

CFR 51.164 and 51.166(h), it must have

definitions of such terms as ‘‘stack,’’

‘‘dispersion technique,’’ and ‘‘good

engineering practice.’’

WDNR Response: On November 6,

1985, the State submitted a letter stating

that permits issued for new or modified

sources will conform with the

requirements with the Stack Height

Regulation, as set forth in the Federal

Register on July 8, 1985, until such time

that the State promulgates it own rule.

EPA Analysis: As submitted, this

provision meets the stack height

requirements of the PSD program, and

EPA approved Wisconsin’s commitment

on August 4, 1989 (54 FR 32074), as a

portion of Wisconsin’s stack height

plan. Wisconsin understands that the

current commitment stated in the

Federal Register document is still

approvable. No additional corrections

are needed.

C. Federally issued PSD permits

1994 Deficiency: The State’s

definition of ‘‘major modification,’’ NR

405.02(21)(b)(c), exempted increases in

hours of operation or production rates

from review unless such increases were

prohibited by permits issued after

January 6, 1975, under NR 405. This

rule was deficient for not requiring

review of sources with such increases if

the increases were prohibited by

previously issued Federal permits or

during the period when EPA issued the

permits prior to the delegation of the

program’s authority. The State rule only

exempted from the exclusion those

permits with conditions ‘‘pursuant to

this chapter,’’ i.e., the Wisconsin rule.

There was no requirement for review of

modifications to federally issued

permits with exemptions pursuant to 40

CFR 52.21.

WDNR Response: Wisconsin changed

the definition of ‘‘major modification’’

(NR 405.02(21)(b)6., to include any

language excluding from exemption

actions prohibited by federally issued

permits pursuant to 40 CFR 52.21.

EPA Analysis: WDNR has adequately

addressed the deficiency.

D. Source specific allowable emissions

1994 Deficiency: NR 405.02(1)

contains the term ‘‘source specific

allowable emissions’’. The meaning of

the term was unclear. The analogous

Federal rule in 40 CFR part 52 depends

upon the preamble language published

in the Federal Register on August 7,

1980 (45 FR 154) to quantify the term

to exclude cases where data on actual

emissions are available. EPA

recommended that the language in NR

405.02(1) be clarified so that the State

term would have the same meaning as

the Federal term.

WDNR Response: Wisconsin

disagreed with EPA’s assessment and

consequently did not take action to

clarify the phrase ‘‘source specific

allowable emissions’’ contained in NR

405.02(1)(b).

Wisconsin noted that EPA

implements the Federal PSD program

under 40 CFR part 52 whereas part 51

contains SIP requirements. EPA has

promulgated the requirements for SIP
65048 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules

approval of the PSD program in 40 CFR

51.166.

Section 40 CFR 51.166(b) states:

‘‘All State plans shall use the following

definitions for the purposes of this section.

Deviations from the following wording will

be approved only if the State specifically

demonstrates that the submitted definition is

more stringent, or at least as stringent, in all

respects as the corresponding definitions

below.’’

Section NR 405.02(1)(b), which

contains the phrase ‘‘source specific

allowable emissions’’ uses this term in

exactly the same manner as EPA uses it

in 40 CFR 51.166(b)(21)(iii), the

definition which 40 CFR 51.166(b)

requires the State plan to use. Nowhere

in 40 CFR 51.166 is there a requirement

that ‘‘source specific allowable

emissions’’ be defined even though it

appears in the part 52 Federal

regulation. Wisconsin asserted that if

EPA wanted States to define this term

in State rules, EPA could have and

should have put such a requirement in

40 CFR 51.166(b).

WDNR also demonstrated that the

requirements in the State rule meet the

SIP requirements in 40 CFR part 51, and

that the preamble in the Federal

Register regarding 40 CFR part 52 does

not apply to 40 CFR part 52 approvals.

EPA Analysis: The State definition

meets the Federal definition found in 40

CFR 51.166(b)(21)(iii) and is approvable.

E. PSD Increments

1994 Deficiency: The State PSD

increments for sulfur dioxide and

particulate matter are found in Chapter

NR 404.05. The increments were not

included in Wisconsin’s March 16, 1987

PSD submittal.

WDNR Response: Wisconsin included

the increments in its November 24,

1992, submittal.

EPA Analysis: WDNR has adequately

addressed the deficiency.

F. Modeling Guidelines

1994 Deficiency: The modeling

guidelines referenced in NR 405.10 were

outdated, although they were current at

the time of the 1987 submittal. To make

NR 405.10 approvable as a SIP revision,

it would either have to reference the

most recent guidelines (see 40 CFR

165(1)) or state that the applicant must

use EPA’s most current applicable

guideline models.

WDNR Response: Wisconsin changed

NR 405.10 to require the use of ‘‘air

quality models, data bases, and other

requirements specified in the Guideline

on Air Quality Models (Revised) in

Appendix W of 40 CFR part 51,

incorporated by reference in NR 484.04.

The rulemaking on this change to NR

405.10 was completed at the same time

as the PM–10 increment rules. The PM–

10 increment rules (AM–27–94) are

being submitted for approval as well.

EPA Analysis: WDNR has adequately

addressed the deficiency.

G. Nitrogen dioxide (NO2) Increments

Original Deficiency: On October 17,

1988 (53 FR 40656), EPA promulgated

PSD air quality increments for NO2. The

States were required to submit to EPA

by July 17, 1990 plan revisions to

protect the NO2 increments.

WDNR Response: Wisconsin

submitted such increments to EPA on

November 24, 1992.

EPA Analysis: This submittal meets

the NO2 increment requirements and is

approvable.

H. Particulate Matter (PM) significant

level

1994 Deficiency: On July 1, 1987 (52

FR 24713), EPA promulgated the

significant level for PM at 15 tons per

year. Wisconsin submitted two PM SIP

revisions on March 13, 1989 and May

10, 1990 to meet the Federal PM

requirements. These submittals were

proposed for approval on March 13,

1989, (NR 400.02, 404.02, 405.02,

406.04, 484.03) which contains the PM

significant level, and May 10, 1990 (NR

404.04, 484.03). EPA then proposed to

disapprove the package on December

23, 1992.

WDNR Response: After receiving

comments from the State, EPA moved to

approve the package. The final

rulemaking approving the PM–10 SIP

rules was published on June 28, 1993

(58 FR 34528).

EPA Analysis: All necessary actions

regarding this deficiency are completed.

Because of the revisions made to NR

405 as a result of the deficiencies raised

in previous analysis, and because the

remainder of NR 405 remains

approvable, NR 405 is being proposed

for approval with respect to meeting the

Act part C requirements.

Chapter NR 405 presumes to apply

PSD regulation within the total area of

the State of Wisconsin. As stated above,

EPA is proposing to approve this rule

for all portions of the State of Wisconsin

except for those sources within the

exterior boundaries of Indian

reservations. EPA will issue PSD

permits, as needed, to all such sources.

III. Final Action

The EPA is proposing to approve the

November 6, 1996, request by the State

of Wisconsin for approval as a revision

to its SIP of its rules meeting the

requirements of part C of the Act, the

adoption of the Federal PM–10

increments, and clarification changes

intended as a ‘‘clean-up’’ of existing air

pollution control rules.

Copies of the State’s submittal and

other information relied upon for this

proposal are contained in a rulemaking

file maintained at the EPA Regional

office. The file is an organized and

complete record of all information

submitted to, or otherwise considered

by, EPA in the development of this

proposed approval. The file is available

for public inspection at the location

listed under the ADDRESSES section of

this document.

IV. Administrative Review

Nothing in this action should be

construed as permitting, allowing or

establishing a precedent for any future

request for revision to any SIP. EPA

shall consider each request for revision

to the SIP in light of specific technical,

economic, and environmental factors

and in relation to relevant statutory and

regulatory requirements.

Under the Regulatory Flexibility Act,

5 U.S.C. 600 et seq., EPA must prepare

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities. (5 U.S.C. 603

and 604) Alternatively, EPA may certify

that the rule will not have a significant

impact on a substantial number of small

entities. Small entities include small

businesses, small not-for-profit

enterprises, and government entities

with jurisdiction over populations of

less than 50,000.

This action is exempt from OMB

review.

V. Unfunded Mandates

Under sections 202, 203, and 205 of

the Unfunded Mandates Reform Act of

1995, signed into law on March 22,

1995, EPA must undertake various

actions in association with proposed or

final rules that include a Federal

mandate that may result in estimated

costs of $100 million or more the private

sector, or to State, local, or tribal

governments in the aggregate.

EPA has determined that the approval

action promulgated does not constitute

a Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector.

Under 5 U.S.C. 801(a)(1)(A) as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, EPA

submitted a report containing this rule

and other required information to the

U.S. Senate, the U.S. House of

Representatives and the Comptroller

General of the General Accounting

Office prior to publication of this rule in
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Proposed Rules 65049

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Intergovernmental relations, New source

review, Nitrogen dioxide, Particulate

matter, Reporting, and recordkeeping

requirements, Sulfur dioxide, Volatile

organic compounds.

Authority: 42 U.S.C. 7401, et seq.

Dated: November 14, 1997.

David A. Ullrich,

Acting Regional Administrator, Region 5.

[FR Doc. 97–31280 Filed 12–9–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[FRL–5932–2]

Approval of Section 112(l) Authority for

Hazardous Air Pollutants;

Perchloroethylene Air Emission

Standards for Dry Cleaning Facilities;

State of California; San Luis Obispo

County Air Pollution Control District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Pursuant to section 112(l) of

the Clean Air Act (CAA) and through

the California Air Resources Board, San

Luis Obispo County Air Pollution

Control District (SLOCAPCD) requested

approval to implement and enforce its

‘‘Rule 432: Perchloroethylene Dry

Cleaning Operations’’ (Rule 432) in

place of the ‘‘National

Perchloroethylene Air Emission

Standards for Dry Cleaning Facilities’’

(dry cleaning NESHAP) for area sources

under SLOCAPCD’s jurisdiction. In the

Rules section of this Federal Register,

EPA is granting SLOCAPCD the

authority to implement and enforce

Rule 432 in place of the dry cleaning

NESHAP for area sources under

SLOCAPCD’s jurisdiction as a direct

final rule without prior proposal

because the Agency views this as a

noncontroversial action and anticipates

no adverse comments. A detailed

rationale for this approval is set forth in

the direct final rule. If no adverse

comments are received in response to

this proposed rule, no further activity is

contemplated in relation to this rule. If

EPA receives 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 rule. The EPA

will not institute a second comment

period on this document. Any parties

interested in commenting on this action

should do so at this time.

DATES: Comments on this proposed rule

must be received in writing by January

9, 1998.

ADDRESSES: Written comments on this

action should be addressed to: Andrew

Steckel, Rulemaking Office (AIR–4), Air

Division, U.S. Environmental Protection

Agency, Region IX, 75 Hawthorne

Street, San Francisco, CA 94105–3901.

Copies of the submitted request are

available for public inspection at EPA’s

Region IX office during normal business

hours.

FOR FURTHER INFORMATION CONTACT: Mae

Wang, Rulemaking Office (AIR–4), Air

Division, U.S. Environmental Protection

Agency, Region IX, 75 Hawthorne

Street, San Francisco, CA 94105–3901,

Telephone: (415) 744–1200.

SUPPLEMENTARY INFORMATION: This

document concerns SLOCAPCD Rule

432, Perchlorothylene Dry Cleaning

Operations, adopted on November 13,

1996. For further information, please see

the information provided in the direct

final action which is located in the

Rules section of this Federal Register.

Authority: This action is issued under the

authority of Section 112 of the Clean Air Act,

as amended, 42 U.S.C. Section 7412.

Dated: November 23, 1997.

Felicia Marcus,

Regional Administrator.

[FR Doc. 97–32330 Filed 12–9–97; 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 notice solicits proposals and

recommendations for developing new

and modifying existing safe harbor

provisions under the Federal and State

health care programs’ anti-kickback

statute, as well as developing new OIG

Special Fraud Alerts. The purpose of

developing these documents is to clarify

OIG enforcement policy with regard to

program fraud and abuse.

DATES: To assure consideration, public

comments must be delivered to the

address provided below by no later than

5 p.m. on February 9, 1998.

ADDRESSES: Please mail or deliver your

written comments to the following

address: Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–21–N, Room

5246, Cohen Building, 330

Independence Avenue, S.W.,

Washington, D.C. 20201. We do not

accept comments by facsimile (FAX)

transmission. In commenting, please

refer to file code OIG–21–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,

S.W., Washington, D.C., 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

business reimbursed under the Federal

or State 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 types of remuneration covered

specifically include kickbacks, bribes,

and rebates, whether made directly or

indirectly, overtly or covertly, or in cash

or in kind. In addition, prohibited

conduct includes not only remuneration

intended to induce referrals of patients,

but remuneration intended to induce

the purchasing, leasing, ordering, or

arranging for any good, facility, service,

or item paid for by Federal or State

health care programs.

Since the statute on its face is so

broad, concern has been expressed for

many years that some relatively

innocuous commercial arrangements are

technically covered by the statute and

are, therefore, subject to criminal

prosecution. As a response to the above

concern, the Medicare and Medicaid

Patient and Program Protection Act of

1987, section 14 of Public Law 100–93,