[Federal Register Volume 60, Number 122 (Monday, June 26, 1995)]
[Rules and Regulations]
[Pages 32916-32917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14727]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001


Health Care Programs: Fraud and Abuse; Technical Revision to the 
Scope and Effect of the OIG Exclusion Regulations

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Final rule.

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SUMMARY: This document sets forth a technical revision to OIG 
regulations on program integrity for Medicare and State Health Care 
programs, concerning the scope and effect of the OIG's program 
exclusion regulations. Prior to this revision, the regulations provided 
that a program exclusion imposed under title XI of the Social Security 
Act was to affect future participation in all Federal nonprocurement 
programs. This revision specifically amends the language in the 
existing regulations to clarify that the scope of an exclusion is now 
applicable to all Executive Branch procurement and non-procurement 
programs and activities. This rule is consistent with the Federal 
Acquisition Streamlining Act, and the Department's Common Rule on 
debarment and suspension which is also being amended and published 
elsewhere in this issue of the Federal Register.

EFFECTIVE DATE: This regulation is effective on August 25, 1995.

FOR FURTHER INFORMATION CONTACT:
Joel J. Schaer, Office of Management and Policy, (202) 619-0089.

SUPPLEMENTARY INFORMATION: 

I. Technical Revision to 42 CFR 1001.1901

    On January 29, 1992, the Department of Health and Human Services 
published a final rule (57 FR 3298) governing the Department's 
exclusion and civil money penalty authorities as established and 
amended by the Medicare and Medicaid Patient and Program Protection Act 
of 1987, Public Law 100-93. These authorities have been delegated to 
the Office of Inspector General (OIG) for implementation. Under these 
regulations, section 1001.1901--Scope and effect of exclusion--
implemented Executive Order 12549 which provides that debarments, 
suspensions and other exclusionary actions taken by any Federal agency 
will have governmentwide effect with respect to all nonprocurement 
programs. Specifically, section 1001.1901 made clear that exclusions 
from Medicare and the State health care programs under title XI of the 
Social Security Act (42 U.S.C. 1320a-7) are also applicable with 
respect to ``all other Federal nonprocurement programs.''
    With the enactment of the Federal Acquisition Streamlining Act 
(FASA) of 1994, Public Law 103-355, congress mandated and expanded the 
governmentwide effect of debarments, suspensions and other exclusionary 
actions to procurement as well as nonprocurement programs and 
activities. In addition to the amendments to the governmentwide Common 
Rule necessitated by the enactment of FASA, we are also specifically 
codifying in the Department's adoption of the Common Rule that 
exclusions imposed under title XI of the Social Security Act will have 
the same governmentwide effect as debarments initiated under the Common 
Rule, and will be recognized and given effect not only for all 
Departmental programs but also for all other Executive Branch 
procurement and nonprocurement programs and activities. In addition, 
because full due process is provided under the statute and the 
implementing regulations for those excluded under title XI--including 
the right to an administrative hearing and judicial review--additional 
due process under the Common Rule is not necessary nor available to 
excluded individuals and entities beyond that set forth in parts 1001 
and 1005 of 42 CFR chapter V. This amendment to section 1001.1901 is 
intended to be consistent with the amendment of 45 CFR part 76 
codifying the requirements of FASA.

II. Regulatory Impact Statement

    The Office of Management and Budget has reviewed this final rule in 
accordance with the provisions of Executive Order 12866. As indicated 
above, the revisions contained in this technical rule are intended to 
clarify that the scope of an OIG exclusion is applicable to all 
Executive Branch procurement and nonprocurement programs and 
activities, consistent with FASA and the Department's Common Rule at 45 
CFR part 76.
    As indicated in the original final rule published on January 29, 
1992, the amendments to 42 CFR part 1001, and this subsequent revision, 
are designed to clarify departmental policy with respect to the 
imposition of program exclusions upon individuals and entities who 
violate the statute. We believe that the vast majority of providers and 
practitioners do not engage in such prohibited activities and 
practices, and that the aggregate economic impact of these provisions 
should be minimal, affecting only those few who have engaged in 
prohibited behavior jeopardizing the Federal health care financing 
programs and beneficiaries. As such, these regulations should have no 
direct effect on the economy or on Federal or State expenditures.
    In addition, in accordance with the Regulatory Flexibility Act (5 
U.S.C. 601 through 612), we certify that this rulemaking will not have 
a significant economic impact on a substantial number of small 
entities. While some sanctions may have an impact on small entities, we 
do not anticipate that a substantial number of these small 
[[Page 32917]] entities will be significantly affected by this 
technical rule.

III. Effective Date and Waiver of Proposed Rulemaking

    On December 20, 1994, all but one of the Federal agencies 
participating in the development of the Common Rule published a notice 
of proposed rulemaking (59 FR 65607) that proposed changes to the 
nonprocurement debarment and suspension Common Rule to provide for 
reciprocal effect between the procurement and nonprocurement 
debarments, suspensions and other exclusionary actions. Since this 
rulemaking is designed to clarify departmental procedures consistent 
with the final Common Rule being set forth in 45 CFR part 76, we are 
waiving the proposed notice and comment period and issuing this 
technical regulation as a final rule that will apply to all pending and 
future cases under this authority.
List of Subjects in 42 CFR Part 1001

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Peer Review Organizations, Penalties, Reporting 
and recordkeeping requirements.

    Accordingly, 42 CFR chapter V, Part 1001 is amended as follows:

PART 1001--PROGRAM INTEGRITY--MEDICARE AND STATE HEALTH CARE 
PROGRAMS

    1. The authority citation for part 1001 is revised to read as 
follows:

    Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7b, 1395u(j), 
1395u(k), 1395y(d), 1395y(e), 1395cc(b)(2)(D), (E) and (F), and 
1395hh; and sec. 2455, Pub. L. 103-355, 108 Stat. 3327 (31 U.S.C. 
6101 note).

    2. In Sec. 1001.1901, paragraph (a) is revised to read as follows:


Sec. 1001.1901  Scope and effect of exclusion.

    (a) Scope of exclusion. Exclusions of individuals and entities 
under this title will be from Medicare, State health care programs, and 
all other Executive Branch procurement and nonprocurement programs and 
activities. The OIG will exclude the individual or entity from the 
Medicare program and direct State agency administering a State health 
care program to exclude the individual or entity for the same period. 
In the case of an individual or entity not eligible to participate in 
Medicare, the exclusion will still be effective on the date, and for 
the period, established by the OIG.
* * * * *
    Approved: May 31, 1995.
June Gibbs Brown,
Inspector General.
[FR Doc. 95-14727 Filed 6-23-95; 8:45 am]
BILLING CODE 4154-04-M