16580 Federal Register / Vol. 60, No. 62 / Friday, March 31, 1995 / Rules and Regulations

to provide the necessary information to

all climbers concerning the hazards

associated with climbing in Denali

National Park.

The NPS is promulgating this interim

rule under the ‘‘good cause’’ exception

of the Administrative Procedure Act (5

U.S.C. 553(b)(B) from general notice and

comment rulemaking. As discussed

above, the NPS believes that this

exception is warranted because of the

time constraints involved. Based upon

this discussion, the NPS finds pursuant

to 5 U.S.C. 533(b)(B) that it would be

contrary to the public interest to publish

a notice of proposed rulemaking. The

NPS is, however, soliciting comments

and will review comments and consider

making changes to the rule based upon

an analysis of comments.

In accordance with the

Administrative Procedure Act (5 U.S.C.

531 et seq.), the NPS has further

determined that publishing this interim

rule 30 days prior to the rule becoming

effective could further delay the

dissemination of safety and resource

related information to climbers. This

also would be contrary to the public

interest and the intended purpose of the

rule. Therefore, under the ‘‘good cause’’

exception of the Administrative

Procedure Act (5 U.S.C. 553(d)(3)), and

as discussed above, the NPS has been

determined that this interim rulemaking

is excepted from the 30-day delay of

effective date, and shall therefore

become effective upon the date

published in the Federal Register.

Because the NPS is soliciting

comments as discussed above, the NPS

plans to analyze comments received and

prepare further rulemaking, as

appropriate.

Public Participation

The policy of the National Park

Service is, whenever practicable, to

afford the public an opportunity to

participate in the rulemaking process.

However, in accordance with the above

discussion, the urgent need to

disseminate the information concerning

the 60-day pre-registration notice and to

ensure the safety of the mountain

climbers, it has been determined that it

is contrary to the public interest to delay

the effective date of this interim rule

pending public comment.

Nevertheless, interested persons are

invited to submit written comments or

suggestions regarding the proposed

regulations to the address noted at the

beginning of this rulemaking. Comments

must be received on or before May 30,

1995. The NPS will review comments

and consider making changes to the rule

based upon an analysis of comments.

Drafting Information

The primary authors of this rule are

Dennis Burnett, Washington Office of

Ranger Activities and Brenda Bussard of

Denali National Park and Preserve,

National Park Service.

Paperwork Reduction Act

This rule does not contain collections

of information which require approval

by the Office of Management and

Budget under 44 U.S.C. 3501 et seq.

Compliance With Other Laws

In accordance with the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq., the

NPS has determined that this interim

rule will not have a significant

economic effect on a substantial number

of small entities, nor does it require a

preparation of a regulatory analysis.

This rule was not subject to Office of

Management and Budget (OMB) review

under Executive Order 12866.

The NPS has determined that this

proposed rulemaking will not have a

significant effect on the quality of the

human environment, health and safety

because it is not expected to:

(a) Increase public use to the extent of

compromising the nature and

character of the area or causing

physical damage to it;

(b) Introduce non-compatible uses

which compromise the nature and

characteristics of the area, or cause

physical damage to it;

(c) Conflict with adjacent ownerships or

land uses; or

(d) Cause a nuisance to adjacent owners

or occupants.

Based on this determination, this

interim rule is categorically excluded

from the procedural requirements of the

National Environmental Policy Act

(NEPA) by Departmental regulations in

516 DM 6 (49 FR 21438). As such,

neither an Environmental Assessment

nor an Environmental Impact Statement

has been prepared.

List of Subjects in 36 CFR Part 13

Alaska, National Parks; Reporting and

recordkeeping requirements.

In consideration of the foregoing, 36

CFR part 13 is amended as follows:

PART 13—NATIONAL PARK SYSTEM

UNITS IN ALASKA

Subpart C—Special Regulations—

Specific Park areas in Alaska

1. The authority citation for part 13

continues to read as follows:

Authority: 16 U.S.C. 1, 3, 462(k), 3101 et

seq.; § 13.65(b) also issued under 16 U.S.C.

1361, 1531.

§ 13.63 [Amended]

2. Section 13.63 is amended by

revising paragraph (f) to read as follows:

* * * * *

(f) Mountain climbing. Climbing on

Mount McKinley or Mount Foraker

without registering, on a form provided

by the Superintendent, at least 60 days

in advance of the climb is prohibited.

Dated: March 23, 1995.

George T. Frampton, Jr.,

Assistant Secretary for Fish and Wildlife and

Parks.

[FR Doc. 95–7906 Filed 3–30–95; 8:45 am]

BILLING CODE 4310–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1003

RIN 0991–AA65

Civil Money Penalties for Referrals to

Entities and for Prohibited

Arrangements and Schemes

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Final rule with comment period.

SUMMARY: This final rule implements

the civil money penalty (CMP)

provisions established through sections

1877(g)(3) and 1877(g)(4) of the Social

Security Act. Specifically, in accordance

with section 1877(g)(3), these

regulations set forth CMPs, assessments

and an exclusion against any person

who presents, or causes to be presented,

a bill or claim the person knows or

should know is for a service unlawfully

referred under section 1877(a)(1)(A) of

the Act, or has not refunded amounts

inappropriately collected for a

prohibited referral. In addition, in

accordance with section 1877(g)(4),

these regulations set forth CMPs,

assessments and an exclusion in cases

where a physician or entity enters into

an arrangement or scheme in which the

physician or entity knows, or should

have known, that the principal purpose

is to assure referrals by the physician

which, if made directly to a particular

entity, would violate the prohibition on

referrals described in section 1877(a) of

the Act.

DATES: Effective date: This final rule

with comment period is effective on

March 31, 1995.

Comment period: Comments on the

applicability of these CMPs for referrals

to ‘‘designated health services’’ resulting

from provisions in the Omnibus Budget

Reconciliation Act (OBRA) of 1993 will
Federal Register / Vol. 60, No. 62 / Friday, March 31, 1995 / Rules and Regulations 16581

be considered if we receive them at the

address specified below, no later than 5

p.m. on May 30, 1995. Broadening these

CMPs to cover referrals to ‘‘designated

health services’’ is discussed in sections

I.C. and IV. of this preamble. We will

not consider comments on provisions

that remain unchanged from the October

20, 1993 proposed rule or on provisions

that were changed based on public

comments.

ADDRESSES: Mail comments to: Office of

Inspector General, Department of Health

and Human Services, Attention: LRR–

30–FC, Room 5246, 330 Independence

Avenue SW., Washington, DC 20201.

If you prefer, you may deliver your

comments to Room 5551, 330

Independence Avenue, SW.,

Washington DC 20201. Because of

staffing and resource limitations, we

cannot accept comments by facsimile

(FAX) transmission. In commenting,

please refer to file code LRR–30–FC.

Comments received timely will be

available for public inspection as they

are received, generally beginning

approximately 3 weeks after publication

of this document, in room 5551, 330

Independence Avenue SW.,

Washington, DC on Monday through

Friday of each week from 8:30 a.m. to

5 p.m., (202) 619–3270.

FOR FURTHER INFORMATION CONTACT:

Joel Schaer, Legislation, Regulations and

Public Affairs Staff, (202) 619–3270.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Omnibus Budget Reconciliation

Acts of 1989 and 1990

In an effort to limit physician referrals

involving laboratory services, section

6204 of Pub. L. 101–239, the Omnibus

Budget Reconciliation Act (OBRA) of

1989, as amended by section 4207(e) of

Pub. L. 101–508 (OBRA of 1990), added

a new section 1877—Limitations on

Certain Physician Referrals—to the

Social Security Act.

As set forth by OBRA 1989 and 1990,

section 1877, with certain exceptions,

prohibited a physician from making a

referral to an entity for the furnishing of

clinical laboratory services for which

Medicare would otherwise pay, if the

physician or a member of the

physician’s immediate family had a

financial relationship with that entity.

(See the discussion in section I.C. below

regarding expansion of this authority to

‘‘designated health services’’ as a result

of amendments set forth in OBRA 1993.)

This provision further prohibited an

entity from presenting, or causing to be

presented, a Medicare claim or bill to

any individual, third party payer or

other entity for laboratory services

furnished in accordance with a

prohibited referral. The authority for

implementing these provisions is a

bifurcated responsibility between the

Health Care Financing Administration

(HCFA) and the OIG. The HCFA has had

the responsibility for developing

regulations that set forth the specific

policies by which such prohibited

conduct is defined, while the OIG has

maintained responsibility for imposing

civil money penalties (CMPs),

assessments and program exclusions for

violations of this referral ban.

B. Proposed HCFA and OIG Regulations

On March 11, 1992, the HCFA issued

proposed regulations (57 FR 8588)

setting forth provisions that would—(1)

with certain specified exceptions,

prohibit a physician from making a

referral to an entity for the furnishing of

laboratory services for which Medicare

would otherwise pay, if the physician or

a member of his or her immediate

family has a financial relationship with

that entity; and (2) prohibit an entity

from presenting or causing to be

presented a Medicare claim or bill for

such services furnished in accordance

with that referral. Because the statute

was quite detailed in scope, the HCFA

proposed rule adhered closely to the

statutory language and adopted—with

little change—several definitions, such

as the definition of prohibited financial

relationships and compensation

arrangements.

In addition, on October 20, 1993 the

OIG issued a proposed rule (58 FR

54096) that was designed to codify the

penalty provisions of the statute set

forth in sections 1877 (g)(3) and (g)(4) of

the Social Security Act. The proposed

rule addressed the establishment of

CMPs of not more than $15,000 for each

violation of the ban on making claims

for services resulting from prohibited

referrals or failing to make a refund, and

CMPs of not more than $100,000 for

physicians and entities who engage in a

circumvention scheme to avoid

detection of prohibited referrals.

C. The Omnibus Budget Reconciliation

Act of 1993

The Omnibus Budget Reconciliation

Act of 1993 expanded the scope of

section 1877 of the Act to extend the

prohibition to Medicare and Medicaid

referrals beyond clinical laboratory

service to include various ‘‘designated

health services.’’ Specifically, OBRA

1993 amended the Medicaid payment

provisions by adding a new section

1903(s) to state that no payments are to

be made to a State for services furnished

by designated health services that

violate the referral prohibitions of

section 1877. The provision is also

applicable to the reporting and penalty

provisions under sections 1877(f) and

(g)(5) of the Act. The designated health

services cover both diagnostic services

and therapeutic items and services,

including physical and occupational

therapy services; radiology services;

radiation therapy services and supplies;

durable medical equipment (DME) and

supplies; parenteral and enteral

nutrients, equipment and supplies;

prosthetics, orthotics and prosthetic

devices and supplies; home health

services; outpatient prescription drugs;

and inpatient and outpatient hospital

services.

These expansions resulting from

OBRA 1993—the expansion to Medicaid

to be effective beginning on December

31, 1994, and the expansion to other

designated health services to be

effective for referrals made after

December 31, 1994—were not

incorporated into either the HCFA or

OIG proposed rules summarized above.

The HCFA intends to publish new

proposed regulations—separate from the

final rule addressing physician

ownership of, and referrals to, entities

that furnish clinical laboratory

services—that will (1) cover how the

referral prohibition applies to additional

services now covered by section 1877 as

the result of OBRA 1993, (2) explain

various new exceptions added to the

statute, and (3) define key terms such as

financial relationship, inpatient/

outpatient services, diagnostic services

and DME.

However, because the penalty

provisions set forth in sections 1877

(g)(3) and (g)(4) of the Act remain

unchanged by these amendments, we

are incorporating by reference the

expansion to designated health services

into our final rulemaking for

sanctioning improper claims and

circumvention schemes. Since the

statutory changes associated with these

penalty provisions are selfimplementing, we believe that the

regulatory revisions set forth in this

rulemaking can be implemented

without interpretation and that public

comment would not substantially

modify these regulations. We believe

that affording additional proposed

rulemaking under these circumstances

is unnecessary and would delay the

promulgation of regulations that

correspond with the current statute.

Therefore, we find good cause to waive

proposed rulemaking for incorporating

the statutory expansion to designated

health services by reference into our

final rulemaking. However, we are

providing a 60-day comment period for
16582 Federal Register / Vol. 60, No. 62 / Friday, March 31, 1995 / Rules and Regulations

comments limited to the area of

designated health services in order to

give parties now covered by these CMP

regulations as providers of designated

health services an opportunity to make

applicable comments. Although these

regulations are being issued as a final

rule, any additional comments will be

considered for possible future

amendments to the rulemaking, where

appropriate.

II. Provisions of the OIG Proposed Rule

The OIG proposed regulations,

published in the Federal Register on

October 20, 1993, provided for a penalty

against any person presenting a bill or

claim to be paid by Medicare for

services furnished under a ‘‘selfreferral’’ arrangement prohibited under

section 1877(a) of the Act, or any person

failing to refund amounts that were

inappropriately billed and collected as

the result of a prohibited referral. The

proposed regulations established—

• A CMP of no more than $15,000 for

each service provided in accordance

with a prohibited referral, for which a

bill or claim was presented, or caused

to be presented, or caused to be

presented, or which was not properly

refunded;

• An assessment of not more than

twice the amount claimed for each

service that was the basis for the CMP;

and

• An exclusion of the individual from

Medicare and State health care program

participation.

In determining the amount of penalty

and assessment for this violation, the

proposed rule specified that the OIG

would apply the five existing criteria set

forth in § 1003.106(a) of the regulations,

and proposed a sixth criterion to be

applied to consider timeliness and

completeness with respect to the

appropriate refund(s).

In addition, the proposed regulations

provided for a penalty against a

physician or entity entering into an

agreement or ‘‘circumvention’’ scheme

to assure referrals which, if they were

made directly, would violate the

prohibition on referrals set out in

section 1877(a) of the Act. One example

of such a scheme would be a crossreferral arrangement where the

physician owners of two different

entities refer to each other. The

proposed regulations established—

• A CMP of not more than $100,000

for each arrangement or circumvention

scheme entered into by a physician or

entity;

• An assessment of not more than

twice the amount claimed by the

physician or entity for each service

billed under the prohibited

arrangement; and

• An exclusion of the physician or

entity form Medicare and State health

care program participation.

In determining the amount of the

penalty and assessment for this

violation, the proposed rule specified

that the OIG would apply the five

existing criteria in § 1003.106(a) of the

regulations, and proposed an additional

criterion that would consider the

amount of ownership interests involved.

III. Response to the Public Comments

In response to this proposed rule, the

OIG received a total of five timely-filed

public comments from associations and

individuals. Set forth below is a

summary of those comments received

and our response to the various

concerns they raised.

Definition of ‘‘Timely Basis’’

Comment: Proposed § 1003.102(b)(8)

stated that the OIG may impose a

penalty against any person ‘‘who has

not refunded on a timely basis amounts

collected as a result of billing an

individual, third party payer or other

entity for a clinical laboratory service

that was provided in accordance with a

prohibited referral * * *’’ (underlining

added). The commenter believes that

providers should be made aware of any

time requirements to which they will be

held accountable, and recommends that

we define the term ‘‘timely basis.’’

Response: We agree with the

commenter that this term should be

clarified, and are defining ‘‘timely

basis’’ in § 1003.101 of the regulations

as the 60 day period from the time the

prohibited amounts are collected. We

believe that there is precedent for

defining this time period.

Currently, the general government

refund policy for overpayments is 30

days. For example, section 1815(d) of

the Social Security Act—addressing

payments to providers under part A of

the Medicare program—requires a

refund (or offset) of excess payments

within 30 days of a final determination

that the amount of payment was in

excess of the amount due. However, the

30 days begins to run after a final

determination is made that there was an

overpayment, while § 1003.102(b)(8) of

our regulations contemplates that the

person who collected amounts for a

service provided in accordance with a

prohibited referral will take the

initiative to refund those amounts on a

timely basis without first being subject

to a ‘‘final determination.’’

The HCFA regulations at 42 CFR

411.24(h) seem more analogous to the

‘‘refund’’ provision addressed in these

penalty provisions than to the

overpayment time periods. These HCFA

Medicare secondary payer regulations

require a beneficiary or other party who

receives a third party payment to

reimburse Medicare within 60 days.

Under 411.24(h), the recipient of the

third party payment is expected to take

the initiative to refund the program,

without first receiving notice, or having

a ‘‘determination’’ by HCFA that the

refund is required. Since the OIG

regulations intend for persons who

profit from prohibited referrals to

initiate making the refund, we believe

that a 60 day period is a reasonable time

period to establish is defining ‘‘timely

basis.’’

Clarifying the Scope of the Regulations

Comment: One commenter asked that

we clarify the regulations text to specify,

as we did in the preamble to the

proposed rule, that physicians—as well

as the laboratory (or designated health

service provider)—may be subject to

CMPs for causing the submission of

claims for services resulting from

prohibited referrals.

Response: We believe that the

language set forth in § 1003.102 is

adequate to cover the scope of these

provisions. The word ‘‘person’’ as

defined in § 1003.101 includes an

individual, trust, estate, partnership,

corporation, professional association or

corporation, or other entity. Physicians,

as ‘‘individuals,’’ are specifically

included under this definition.

Criteria for Circumvention Scheme

Sanctions

Comment: The rulemaking proposed

adding a new criterion in § 1003.106(a)

that would take into account the amount

of ownership interests involved when

determining penalty amounts or

assessments for circumvention schemes.

One commenter strongly supported this

criterion of requiring providers to

disclose the amount of ownership

interest whenever making an ownership

disclosure under section 1877 rather

than just the fact of ownership interest

in a facility.

Response: We appreciate the

commenter’s support of this additional

criterion, and believe that requiring the

provider to disclose the amount of

ownership will act as a further deterrent

to providers referring patients to

facilities in which they have financial

interests.

Comment: In referencing both

§ 1003.102(b)(9) of the proposed

regulations and existing § 1003.102(c),

one commenter raised concerns

regarding the ability of outside third

parties to effectively counsel
Federal Register / Vol. 60, No. 62 / Friday, March 31, 1995 / Rules and Regulations 16583

practitioners if such counseling

activities were considered subject to

penalties as part of a ‘‘circumvention’’

scheme. The commenter expressed

concern that the regulation would

discourage lawyers, accountants and

other professionals from advising

physicians on how to set up practices

for fear that the advising professional

would be ‘‘adding and abetting’’ a

violation.

Response: This regulation is directed

specifically at physicians and entities

that enter into a ‘‘cross-referral

arrangement’’ or a scheme which the

physician or entity knows or should

know is designed to circumvent the

prohibitions of this provision. It should

in no way discourage physicians from

seeking professional advice in good

faith, or discourage attorneys and

accountants from giving such advice in

good faith.

Resource Issues

Comment: One commenter took issue

with the regulatory impact statement

that states the rulemaking will have no

direct effect on the economy or on

Federal or State expenditures. The

commenter believes that there will be a

considerable increase in the workload of

Medicare auditors and fraud units in

their efforts to detect fraud and abuse,

and believes that the impact statement

should reflect these increased activities.

In addition, based on information a

second commenter is currently

receiving on physician ownership of

other entities when individuals are

requesting provider numbers, the

commenter indicated that they would

need to establish specific flags or edits

to be adequately apprised of situations

involving potential violations.

Response: We do not believe that

these penalty provisions will result in

significantly increased expenditures for

detection efforts in this area, and believe

that these concerns do not warrant

altering the existing regulatory impact

statement. While we do not anticipate

funding levels to significantly increase

as a result of this additional authority,

we remain acutely aware of the issue

and need for resources in general, and

will continue to invite and rely on

active participation from within the

health care industry to aid in efforts to

accurately and effectively identify and

police self-referral violations.

Delaying Issuance of the Final OIG

Regulations

Comment: One commenter asked that

issuance of the OIG final penalty

provisions be delayed until HCFA has

promulgated both sets of final

implementing regulations addressing

prohibited referrals and prohibited

arrangements and schemes under

section 1877 of the Act.

Response: As indicated above, HCFA

plans two separate rulemaking

initiatives—one addressing clinical

laboratory services and a second for

designated health services—to address

the prohibitions set forth in section

1877 of the Act. The OIG has always

maintained, however, that its statutory

CMP authorities are independent

authorities under which it may bring

enforcement actions before regulations

are published. For that reason, we do

not believe that it is necessary for the

OIG to wait upon finalization of HCFA’s

regulations to publish in final form our

CMP regulations addressing the penalty

and enforcement provisions of sections

1877 (g)(3) and (g)(4).

IV. Technical Changes

As discussed above, we are

incorporating into this final rule the

expansion of section 1877 resulting

from OBRA 1993 to include Medicare

payments for much of the health care

industry, i.e., for clinical laboratory

services and the additional ten

‘‘designated health services’’ effective

for referrals made after December 31,

1994.

V. Cross-References to the HCFA

Regulations

Sections 1003.100(b)(1) (ix)–(xi),

1003.102(a)(5) and 1003.102 (b)(9) and

(b)(10) cross-reference HCFA

regulations’ §§ 411.351 and 411.353 that

will not be codified until the HCFA

Physician Referral rules are published

in final form. We note that these

citations to the HCFA regulations are

tentative and will be amended, if

necessary, when those provisions are

finalized.

VI. Regulatory Impact Statement

The Office of Management and Budget

has reviewed this final rule with

comment period in accordance with the

provisions of Executive Order 12866. As

discussed above, the provisions

contained in this rulemaking set forth

new authorities to the OIG for levying

CMPs against persons or entities that

file claims for services furnished on the

basis of prohibited referrals or who

engaged in prohibited circumvention

schemes proscribed by statute. These

provisions are a result of statutory

changes and serve to clarify

departmental policy with respect to the

imposition of CMPs against persons and

entities who violate the statute. We

believe that the great majority of

providers and practitioners do not

engage in such prohibited activities and

practices discussed in these regulations.

As a result, we believe that the aggregate

economic impact of these provisions

will be minimal, affecting only those

who have engaged in prohibited

behavior in violation of the statute. As

such, this final rule should have no

effect on the economy or on Federal or

State expenditures.

In addition, we generally prepare a

regulatory flexibility analysis consistent

with the Regulatory Flexibility Act (5

U.S.C. 601 through 612) unless the

Secretary certifies that a regulation will

not have a significant economic impact

on a substantial number of small

business entities. While some sanctions

and penalties may have an impact on

small entities, we do not anticipate that

a substantial number of these small

entities will be significantly affected by

this rulemaking. Therefore, we have

concluded, and the Secretary certifies,

that a regulatory flexibility analysis is

not required for this final rule.

List of Subjects in 42 CFR Part 1003

Administrative practice and

procedure, Fraud, Grant programs—

health, Health facilities, Health

professions, Maternal and child health,

Medicaid, Medicare, Penalties.

42 CFR part 1003 is amended as set

forth below:

PART 1003—CIVIL MONEY

PENALTIES, ASSESSMENTS AND

EXCLUSIONS

1. The authority citation for part 1003

is revised to read as follows:

Authority: 42 U.S.C. 1302, 1320–7, 1320a–

7a, 1320b–10, 1395u(j), 1395u(k),

1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d),

1396b(m), 11131(c) and 11137(b)(2).

2. Section 1003.100 is amended by

revising paragraph (a); by republishing

paragraph (b)(1) introductory text; by

revising paragraphs (b)(1)(vi) and

(b)(1)(vii); and by adding new

paragraphs (b)(1)(viii)–(xi) to read as

follows:

§ 1003.100 Basis and purpose.

(a) Basis. This part implements

sections 1128(c), 1128A, 1140, 1842(j),

1842(k), 1876(i)(6), 1877(g), 1882(d) and

1903(m)(5) of the Social Security Act,

and sections 421(c) and 427(b)(2) of

Pub. L. 99–660 (42 U.S.C. 1320a–7,

1320a–7a, 1320a–7(c), 1320b(10),

1395mm, 1395ss(d), 1395u(j), 1395u(k),

1396b(m), 11131(c) and 11137(b)(2)).

(b) Purpose. * * *

(1) Providers for the imposition of

civil money penalties and, as

applicable, assessments against persons

who—

* * * * *
16584 Federal Register / Vol. 60, No. 62 / Friday, March 31, 1995 / Rules and Regulations

(vi) Violate a requirement of section

1867 of the Act or § 489.24 of this title;

(vii) Substantially fail to provide an

enrollee with required medically

necessary items and services, or engage

in certain marketing, enrollment,

reporting, claims payment, employment

or contracting abuses; or

(viii) Have submitted certain

prohibited claims under the Medicare

program;

(ix) Present or cause to be presented

a bill or claim for designated health

service (as defined in § 411.351 of this

title) that they know, or should know,

were furnished in accordance with a

referral prohibited under § 411.353 of

this title;

(x) Have collected amounts that they

know or should know were billed in

violation of § 411.353 of this title and

have not refunded the amounts

collected on a timely basis; or

(xi) Are physicians or entities that

enter into an arrangement or scheme

that they know or should know has as

a principal purpose the assuring of

referrals by the physician to a particular

entity which, if made directly, would

violate the provisions of § 411.353 of

this title.

* * * * *

3. Section 1003.101 is amended by

adding a definition for the term timely

basis to read as follows:

§ 1003.101 Definitions

* * * * *

Timely basis means, in accordance

with § 1003.102(b)(9) of this part, the

60-day period from the time the

prohibited amounts are collected by the

individual or the entity.

* * * * *

4. Section 1003.102 is amended by

revising paragraphs (a)(3), (a)(4)

introductory test, and (a)(4)(iii); and by

adding paragraphs (a)(5), (b)(9) and

(b)(10) to read as follows:

§ 1003.102 Basis for civil money penalties

and assessments.

(a) * * *

(3) An item or service furnished

during a period in which the person was

excluded from participation in the

program to which the claim was made

in accordance with a determination

made under sections 1128 (42 U.S.C.

1320a–7), 1128A (42 U.S.C. 1320a–7a),

1156 (42 U.S.C. 1320c–5), 1160(b) as in

effect on September 2, 1982 (42 U.S.C.

1320c–9(b)), 1842(j)(2) (42 U.S.C.

1395u(j)), 1862(d) as in effect on August

18, 1987 (42 U.S.C. 1395y(d)), or 1866(b)

(42 U.S.C. 1395cc(b));

(4) A physician’s services (or an item

or service) for which the person knew,

or should have known, that the

individual who furnished (or supervised

the furnishing of) the service—

* * * * *

(iii) Represented to the patient at the

time the service was furnished that the

physician was certified in a medical

specialty board when he or she was not

so certified; or

(5) A payment that such person

knows, or should know, may not be

made under § 411.353 of this title.

(b) * * *

(9) Has not refunded on a timely

basis, as defined in § 1003.101 of this

part, amounts collected as the result of

billing an individual, third party payer

or other entity for a designated health

service that was provided in accordance

with a prohibited referral as described

in § 411.353 of this title;

(10) Is a physician or entity that enters

into—

(i) A cross referral arrangement, for

example, whereby the physician owners

of entity ‘‘X’’ refer to entity ‘‘Y,’’ and the

physician owners of entity ‘‘Y’’ refer to

entity ‘‘X’’ in violation of § 411.353 of

this title, or

(ii) Any other arrangement or scheme

that the physician or entity knows, or

should know, has a principal purpose of

circumventing the prohibitions of

§ 411.353 of this title.

* * * * *

5. Section 1003.103 is amended by

revising paragraphs (a) and (b) to read

as follows:

§ 1003.103 Amount of penalty.

(a) Except as provided in paragraphs

(b), (c) and (d) of this section, the OIG

may impose a penalty of not more than

$2,000 for each item or service that is

subject to a determination under

§ 1003.102.

(b) The OIG may impose a penalty of

not more than $15,000 for each person

with respect to whom a determination

was made that false or misleading

information was given under

§ 1003.102(b)(4), or for each item and

service that is subject to a determination

under § 1003.102(a)(5) or

§ 1003.102(b)(9) of this part. The OIG

may impose a penalty of not more than

$100,000 for each arrangement or

scheme that is subject to a

determination under § 1003.102(b)(10)

of this part.

* * * * *

6. Section 1003.106 is amended by

revising paragraph (a)(1) introductory

text and paragraph (a)(1)(iv); by

redesignating paragraph (a)(1)(v) as

paragraph (a)(1)(vii); and by adding new

paragraphs (a)(1)(v) and (a)(1)(vi) to read

as follows:

§ 1003.106 Determination regarding the

amount of the penalty and assessment.

(a) Amount of penalty. (1) In

determining the amount of any penalty

or assessment in accordance with

§ 1003.102 (a), (b)(1), (b)(4), (b)(9), and

(b)(10), the Department will take into

account—

* * * * *

(iv) The financial condition of the

person presenting the claim or request

for payment, or giving the information;

(v) The completeness and timeliness

of the refund with respect to

§ 1003.102(b)(9);

(vi) The amount of financial interest

involved with respect to

§ 1003.102(b)(10); and

* * * * *

Dated: October 4, 1994.

June Gibbs Brown,

Inspector General.

Approved: December 30, 1994.

Donna E. Shalala,

Secretary.

[FR Doc. 95–7845 Filed 3–30–95; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Public Land Order 7129

[WY–930–1430–01; WYW–92953–01]

Revocation of Executive Order No.

3410, Dated February 22, 1921;

Wyoming

AGENCY: Bureau of Land Management,

Interior.

ACTION: Public Land Order.

SUMMARY: This order revokes an

Executive order that involves 2,844.17

acres of National Forest System land

withdrawn for powersite purposes in

the Shoshone National Forest. The land

is no longer needed for powersite

purposes. This action will open

2,336.22 acres to such forms of

disposition as may by law be made of

National Forest System land, including

exchange under the General Exchange

Act of 1922. The 2,336.22 acres has been

open to mining under the provisions of

the Mining Claims Rights Restoration

Act of 1955, and these provisions are no

longer required. There are 427.95 acres

that would remain closed to disposal by

an overlapping withdrawal. The

remaining 80 acres have been conveyed

into private ownership with revocation

being a record clearing action as it

pertains to that land. The entire acreage,

with the exception of the 80 acres,