[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40114-40115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General


Solicitation of Information and Recommendations for Revising 
OIG's Non-Binding 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 and Opportunity for Comment.

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SUMMARY: This Federal Register notice informs the public that OIG: (1) 
Is considering revising the Non-Binding Criteria for Implementing 
Permissive Exclusion Authority Under Section 1128(b)(7) of the Social 
Security Act (62 FR 67392, December 24, 1997), and (2) is soliciting 
input from the public for OIG to consider in developing the revised 
criteria.

DATES: To ensure consideration, public comments must be delivered to 
the address provided below by no later than 5 p.m. on September 9, 
2014.

ADDRESSES: In commenting, please refer to file code OIG-1271-N. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):

[[Page 40115]]

    1. Electronically. You may submit electronic comments on specific 
recommendations and proposals through the Federal eRulemaking Portal at 
http://www.regulations.gov.
    2. By regular, express, or overnight mail. You may send written 
comments to the following address: Patrice Drew, Office of Inspector 
General, Department of Health and Human Services, Attention: OIG-1271-
N, Room 5296, Cohen Building, 330 Independence Avenue SW., Washington, 
DC 20201. Please allow sufficient time for mailed comments to be 
received before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver, by hand or 
courier, your written comments before the close of the comment period 
to Patrice Drew, Office of Inspector General, Department of Health and 
Human Services, Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201. Because access to the interior of the Cohen 
Building is not readily available to persons without Federal Government 
identification, commenters are encouraged to schedule their delivery 
with one of our staff members at (202) 619-1368.
    For information on viewing public comments, please see the 
Supplementary Information section.

FOR FURTHER INFORMATION CONTACT: Patrice Drew, Department of Health and 
Human Services, Office of Inspector General, Office of External 
Affairs, at (202) 619-1368.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the end 
of the comment period are available for viewing by the public. All 
comments will be posted on http://www.regulations.gov as soon as 
possible after the closing of the comment period. Comments received 
timely will also be available for public inspection as they are 
received at Office of Inspector General, Department of Health and Human 
Services, Cohen Building, 330 Independence Avenue SW., Washington, DC 
20201, Monday through Friday of each week from 10 a.m. to 4 p.m. To 
schedule an appointment to view public comments, phone (202) 619-1368.

Background

    Section 1128(b)(7) of the Social Security Act (Act) authorizes the 
Secretary, and by delegation the Inspector General, to exclude an 
individual or entity from participation in the Federal health care 
programs for engaging in conduct described in sections 1128A and 1128B 
of the Act. In general, OIG may seek to exclude any person who violates 
the Federal False Claims Act, 31 U.S.C. 3729-3733, or the Civil 
Monetary Penalties Law, section 1128A of the Act. For example, 
submitting or causing the submission of false or fraudulent claims or 
soliciting or paying kickbacks in violation of the Federal Anti-
Kickback Statute, section 1128B of the Act, can result in exclusion 
from participation in Medicare, Medicaid, and all other Federal health 
care programs. On October 24, 1997, OIG published a proposed policy 
statement in the Federal Register (62 FR 55410) in the form of non-
binding criteria to be used by OIG in assessing whether to impose a 
permissive exclusion under section 1128(b)(7) of the Act. On December 
24, 1997, OIG published the final policy statement in the Federal 
Register (62 FR 67392).
    Since 1997, OIG has used these criteria to evaluate whether to 
impose a permissive exclusion under section 1128(b)(7) of the Act or 
release this authority in exchange for the defendant's entering into an 
Integrity Agreement with OIG. On the basis of our experience evaluating 
permissive exclusion in False Claims Act and administrative cases over 
the past 17 years, we are considering revising the existing criteria. 
We believe revised criteria may help the provider community understand 
how OIG exercises its discretion in cases under section 1128(b)(7) of 
the Act. We also believe that updated guidance could better reflect the 
state of the health care industry today, including the changes in legal 
requirements and the emergence of the health care compliance industry.
    In considering possible revisions to the criteria, we are 
soliciting comments, recommendations, and other suggestions from 
concerned parties on how best to revise the criteria to address 
relevant issues and to provide useful guidance to the health care 
industry. The issues we are considering include, but are not limited 
to: (1) Whether there should be differences in the criteria for 
individuals and entities and (2) whether and how to consider a 
defendant's existing compliance program.
    After reviewing any timely submitted comments, we will decide 
whether and how to revise the non-binding criteria for use in 
evaluating exclusion under 1128(b)(7) of the Act where the defendant 
has defrauded the Federal health care programs.

    Dated: June 7, 2014.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2014-16222 Filed 7-10-14; 8:45 am]
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