67392 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Notices

42 CFR OMB control Nos.

488.1–.28 ........................................................................................................................................................................ 0938–0355

488.4 ............................................................................................................................................................................... 0938–0690

488.18 ............................................................................................................................................................................. 0938–0667

488.26 ............................................................................................................................................................................. 0938–0379

488.60 ............................................................................................................................................................................. 0938–0360

489.20 ............................................................................................................................................................................. 0938–0667

489.21 ............................................................................................................................................................................. 0938–0357

489.24 ............................................................................................................................................................................. 0938–0667

489.27 ............................................................................................................................................................................. 0938–0692

489.40–.41 ...................................................................................................................................................................... 0938–0383

489.102 ........................................................................................................................................................................... 0938–0610

491.1–.11 ........................................................................................................................................................................ 0938–0074

491.2 ............................................................................................................................................................................... 0938–0685

491.9 ............................................................................................................................................................................... 0938–0334

493.1–.2001 .................................................................................................................................................................... 0938–0151, 0170, 0544,

0581, 0612 & 0653

493.501, 493.506, 493.513, 493.515 .............................................................................................................................. 0938–0686

493.1840 ......................................................................................................................................................................... 0938–0655

498.40–.95 ...................................................................................................................................................................... 0938–0486 & 0567

1003.100, 1003.101, 1003.103 ....................................................................................................................................... 0938–0700

1004.40, 1004.50, 1004.60, 1004.70 .............................................................................................................................. 0938–0444

45 CFR OMB control Nos.

146.111, .115, .117, .150, .152, .160, .180 .................................................................................................................... 0938–0702

148.120, .122, .124, .128 ................................................................................................................................................ 0938–0703

Dated: December 17, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group;

Division of HCFA Enterprise Standards.

[FR Doc. 97–33555 Filed 12–23–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Criteria for Implementing Permissive

Exclusion Authority Under Section

1128(b)(7) of the Social Security Act

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This notice sets forth the nonbinding guidelines, to be used by the

OIG in assessing whether to impose a

permissive exclusion in accordance

with section 1128(b)(7) of the Social

Security Act. These guidelines identify

specific factors with regard to whether

an individual’s or entity’s continued

participation in the Medicare, Medicaid

and other Federal health care programs

will pose a risk to the programs or

program beneficiaries, and explain how

these factors would be used by the OIG

to assess a permissive exclusion

decision.

FOR FURTHER INFORMATION CONTACT:

Joel Schaer, Office of Counsel to the

Inspector General (202) 619–0089.

SUPPLEMENTARY INFORMATION:

I. Background

Purpose and Rationale

Section 1128(b)(7) of the Social

Security Act (the Act) authorizes the

Secretary, and by delegation the

Inspector General, to exclude a provider

from Medicare, Medicaid and the other

Federal health care programs for

engaging in conduct described in

sections 1128A and 1128B of the Act.

These latter provisions establish

administrative and criminal sanctions,

respectively, against individuals and

entities that (1) submit, or cause to be

submitted, false or fraudulent claims to

Medicare and the Federal and State

health care programs; or (2) offer, pay,

solicit or receive remuneration in return

for the referral of business reimbursed

by Medicare or Medicaid, a violation of

the Medicare and Medicaid antikickback statute. Exclusions in

accordance with section 1128(b)(7) of

the Act, based on such conduct, are

permissive in nature, that is, the

Secretary has the discretion whether to

exclude or not to exclude. Respondents

in these administrative exclusion

proceedings have the right to a hearing

before a Department of Health and

Human Services administrative law

judge prior to the imposition of an

exclusion.

On October 24, 1997, the OIG

published a proposed policy statement

in the Federal Register (62 FR 55410) in

the form of non-binding guidelines to be

used by the OIG in assessing whether to

impose a permissive exclusion in

accordance with section 1128(b)(7) of

the Act. We indicated that these draft

criteria were designed to allow for the

more effective development of OIG

investigations and investigative plans;

establish an objective basis for the OIG’s

permissive exclusion decisions;

evaluate a provider’s trustworthiness to

continue to conduct business with the

Medicare, Medicaid and other Federal

health care programs; and positively

influence providers’ future behavior

through the development of corporate

integrity programs and other conduct

contemplated by the exclusion criteria.

The factors listed in these proposed

guidelines were derived from two

principal sources—the regulations

governing exclusions under sections

1128(b)(7) and 1128A of the Act (42 CFR

parts 1001 and 1003), and the decisions

of the Departmental Appeals Board

(DAB) in exclusion matters. The factors

derived from DAB decisions reflected

the analysis of the remedial purpose of

program exclusion that is, to protect

Federal health care programs by

determining whether the respondent is

sufficiently trustworthy to participate.

Structure of Permissive Exclusion

Criteria

The proposed exclusion criteria were

organized into four general categories of

factors bearing on the trustworthiness of

a provider that has allegedly engaged in

health care fraud and abuse—

• The first category addressed the

circumstances and seriousness of the
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Notices 67393

underlying misconduct. The factors to

be considered are historical in nature

and rely on past misconduct as an

indicator of the defendant’s propensity

for future abuse of the programs.

• The second category considered the

defendant’s response to the allegations

or determination of wrongdoing. These

factors indicate whether the defendant

is willing to affirmately modify his or

her conduct, make injured parties

whole, and otherwise acknowledge and

remedy past wrongdoing.

• The third category identified

various other factors relevant to

assessing the likelihood of a future

violation of the law. The

implementation of an adequate

corporate integrity program is a key

consideration.

• The fourth category related to the

defendant’s financial ability to provide

quality health care services.

Interested parties were invited to

comment on these draft criteria and

submit their written comments to the

OIG for consideration. The OIG received

two timely-filed public comments in

accordance with that solicitation

request. As a result of those comments,

we are making two technical revisions

to the final guidelines. The first change

relates to section D and the defendant’s

financial ability to provide quality

health care services. We are clarifying

this section to indicate its application

only to entities and not individual

practitioners. Second, we are revising

the language in paragraph 3 of section

A to address the ‘‘knowledge standard.’’

Specifically, we are now indicating that

a criterion would be whether there is

evidence that the defendant knew, or

should have known, that his or her

conduct was prohibited.

We believe that the revised internal

guidelines set forth below should now

establish specific criteria on which the

OIG may base its decision as to whether

to seek the imposition of a permissive

exclusion against a health care provider

in accordance with section 1128(b)(7) of

the Act. While these revised exclusion

criteria will now serve as internal

agency guidelines for the OIG, these

criteria may be subject to further

modification at any time. They are not

intended to limit or bind the OIG’s

discretionary authority to exclude

individuals or entities that pose a risk

to Medicare, Medicaid and other

Federal health care programs or program

beneficiaries. These criteria do not

create any rights or privileges in favor

of any party. In addition, these criteria

do not supplant to modify in any way

the OIG regulations, codified at 42 CFR

part 1001, governing program

exclusions.

II. Criteria To Implement the OIG’s

Permissive Exclusion Authority Under

Section 1128(b)(7)

The following criteria may be used to

determine whether or not it is

appropriate to impose a permissive

exclusion in accordance with section

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

7(b)(7)). These criteria are informal and

non-binding, and may be used as a

guide to assist the OIG in determining

in which cases an exclusion should be

imposed. The presence or absence of

any or all of the factors that appear

below does not constitute the sole

grounds for determining whether

exclusion is appropriate. There is a

presumption that some period of

exclusion should be imposed against an

individual or entity that has defrauded

Medicare or other Federal and State

health care programs.

A. The Circumstances of the Misconduct

and Seriousness of the Offense

1. Was a criminal sanction imposed?

The amount of any criminal fine or

penalty imposed, and the length of any

period of incarceration that is ordered,

is evidence of the seriousness of the

statutory misconduct, and may have an

impact on the exclusion determination.

2. Was there evidence of (i) physical

or mental harm to patients or (ii)

financial harm to the Medicare or any of

the other Federal and State health care

programs? If financial loss to the

programs occurred, what was the extent

of such loss? Exclusion may be

appropriate not only in cases where

actual harm is present, but potential

harm as well.

3. Is the misconduct an isolated

incident or a continuous pattern of

wrongdoing over a significant period of

time? Is there evidence that the

defendant knew, or should have known,

that his or her conduct was prohibited?

Has the defendant had the same or

previous problems with the OIG, the

Health Care Financing Administration

(HCFA), the carrier or intermediary, or

the State? What was the nature of these

problems?

4. Was the defendant’s involvement in

the misconduct active or passive? Was

the defendant aware of the misconduct

when it was occurring? Did the

defendant play a role in the

misconduct?

B. Defendant’s Response to Allegations/

Determination of Unlawful Conduct

1. What was the defendant’s response

to any actual or potential legal

violations or harm to the programs or

their beneficiaries? Was the response

appropriate and credible?

2. Did the defendant cooperate with

investigators and prosecutors, and

timely respond to lawful requests for

documents and the provision of

evidence regarding the involvement of

other individuals in a particular

scheme, thereby demonstrating

trustworthiness?

3. Has the defendant made or agreed

to make full restitution to the Federal

and/or state health care programs,

thereby demonstrating present

responsibility and willingness to

conform to applicable laws, regulations

and program requirements?

4. Has the defendant paid or agreed to

pay all criminal, civil, and

administrative fines, penalties, and

assessments resulting from the improper

activity?

5. Has the defendant taken steps to

undo the questionable conduct or

mitigate the ill effects of the

misconduct, e.g., appropriate

disciplinary action against the

individuals responsible for the activity

that constitutes cause for exclusion, or

other corrective action?

6. Has the defendant acknowledged

its wrongdoing and changed its

behavior, thereby demonstrating future

trustworthiness?

C. Likelihood that Offense or Some

Similar Abuse Will Occur Again

1. Was the misconduct the result of a

unique circumstance not likely to recur?

Is there minimal risk of repeat conduct?

2. Have prior and subsequent conduct

been exemplary or improper?

3. What prior measures had been

taken to ensure compliance with the

law? Can the defendant demonstrate

that it had an effective compliance plan

in place when the activities that

constitute cause for exclusion occurred?

A. Did the defendant make any efforts

to contact the OIG, HCFA, or its

contractors to determine whether its

conduct complied with the law and

applicable program requirements? Were

any contacts documented?

B. Did the defendant bring the activity

in question to the attention of the

appropriate Government officials prior

to any Government action, e.g., was

there any voluntary disclosure regarding

the alleged wrongful conduct?

C. Did the defendant have effective

standards of conduct and internal

control systems in place at the time of

the wrongful activity, e.g., was there a

corporate compliance program in place?

If there was an existing corporate

compliance plan:

(i) How long had the compliance plan

been in effect?
67394 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Notices

(ii). What problems had been

identified as a result of the compliance

plan?

(iii). Were any overpayments or

systemic changes made if problems

were identified?

(iv) Were appropriate staff sufficiently

trained in applicable policies and

procedures pertaining to Medicare and

other Federal and State health care

programs?

(v) Was there a corporate compliance

officer and an effective corporate

compliance committee in place (if

appropriate to the size of the company)?

(vi) Were regular audits undertaken at

the time of the unlawful activity?

4. What measures have been taken, or

will be taken, to ensure compliance

with the law? Has the defendant agreed

to implement adequate compliance

measures, including institution of a

corporate integrity plan?

D. Financial Responsibility

If the defendant is an entity and is

permitted to continue program

participation, is that defendant able to

operate without a real threat of

bankruptcy and without a real threat to

its ability to provide quality health care

items or services?

Dated: December 16, 1997.

June Gibbs Brown,

Inspector General.

[FR Doc. 97–33524 Filed 12–23–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health (NIH)

National Institute on Aging; Notice of

Meeting of the National Advisory

Council on Aging

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Council on Aging,

National Institute on Aging, Thursday,

February 5, and Friday, February 6,

1998, to be held at the National

Institutes of Health, Natcher Building,

Conference Room F1 and 2, Bethesda,

Maryland. This meeting will be open to

the public on Thursday, February 5,

from 1:00 to 4:30 p.m. for a status report

by the Director, NIA, and the Behavioral

and Social Research Program and

Intramural Research Program Reviews.

The meeting will be open again on

Friday, February 6, from 8:00 to 10:00

a.m. for a report on the Working Group

on Program, a report on the Council

Task Force on Minority Aging and

Highlights of Recent Research Findings.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5, U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting of the Council will

be closed to the public on Thursday,

February 5, from 4:30 p.m. to recess for

the review of the Intramural Research

Program.

The meeting will also be closed on

Friday, February 6, from 10:00 a.m. to

adjournment for the discussion and

evaluation of grant applications. These

applications and the discussions could

reveal confidential trade secrets or

commercial property such as a

patentable material and personal

information concerning individuals

associated with the applications, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

Ms. June McCann, Committee

Management Officer for the National

Institute on Aging, National Institutes of

Health, Gateway Building, 7201

Wisconsin Avenue, Suite 2C218,

Bethesda, Maryland 20892 (301/496–

9322), will provide a summary of the

meeting and a roster of committee

members upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. McCann at (301) 496–9322,

in advance of the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.866, Aging Research,

National Institutes of Health)

Dated: December 17, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–33490 Filed 12–23–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Closed

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Environmental

Health Sciences Special Emphasis Panel

(SEP) meeting:

Name of SEP: Review of Conference Grants

(R13s) and Conference Cooperative

Agreements (U13s) Telephone Conference

Call.

Date: January 9, 1998.

Time: 2:30 p.m.

Place: National Institute of Environmental

Health Sciences, North Campus, Building

4401, Room 3446, Research Triangle Park,

NC 27709.

Contact Person: Dr. Carol Shreffler,

National Institute of Environmental Health

Sciences, P.O. Box 12233, Research Triangle

Park, NC 27709, (919) 541–1445.

Purpose/Agenda: To review and evaluate

grant applications.

This meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Grant applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.113, Biological Response to

Environmental Agents; 93.114, Applied

Toxicological Research and Testing; 93.115,

Biometry and Risk Estimation; 93.894,

Resource and Manpower Development,

National Institutes of Health)

Dated: December 17, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–33491 Filed 12–23–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Allergy and

Infectious Diseases; Notice of Meeting:

Allergy, Immunology, and

Transportation Research Committee

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

Allergy, Immunology, and

Transplantation Research Committee on

February 10–12, 1998, at the Belmont

Manor House and Conference Center,

6555 Belmont Woods Road, Elkridge,

Maryland.

The meeting will be open to the

public from 8:30 a.m. to 9:30 a.m. on

February 10 to discuss administrative

details relating to committee business

and program review, and for a report

from the Acting Director, Division of

Extramural Activities, which will

include a discussion of budgetary

matters. Attendance by the public will

be limited to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5, U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public for the review, discussion,

and evaluation of individual grant

applications and contract proposals

from 9:30 a.m. on February 10 until