[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Pages 36281-36282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14585]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
[Docket Number OIG-1301-N]
Solicitation of Information and Recommendations for Revising
OIG's Provider Self-Disclosure Protocol
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)
Intends to update the Provider Self-Disclosure Protocol (63 FR 58399,
October 30, 1998) and (2) solicits input from the public for OIG to
consider in updating the Protocol.
DATES: To ensure consideration, public comments must be delivered to
the address provided below by no later than 5 p.m. on August 17, 2012.
ADDRESSES: In commenting, please refer to file code OIG-1301-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):
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: Kenneth D. Kraft, Office of
Inspector General, Department of Health and Human Services, Attention:
OIG-1301-N, Room 5541B, 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 Kenneth D. Kraft, 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 at (202) 708-9848.
All submissions must include the agency name and docket number for
this Federal Register document. All comments, including attachments and
other supporting material received, are subject to public disclosure.
FOR FURTHER INFORMATION CONTACT: Kenneth D. Kraft, Department of Health
and Human Services, Office of Inspector General, Office of External
Affairs, at (202) 708-9848.
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 after they have been received. 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 8:30 a.m. to 4 p.m. To
schedule an appointment to view public comments, phone (202) 708-9848.
Background: In 1998, OIG published the Provider Self-Disclosure
Protocol (the Protocol) to establish a process for health care
providers to disclose potential fraud involving the Federal health care
programs. The Protocol provides guidance on how to investigate this
conduct, quantify damages, and report the conduct to OIG to resolve the
provider's liability exposure under OIG's civil money penalty (CMP)
authorities. Over the past 14 years, we have resolved over 800
disclosures, resulting in recovering over $280 million to the Federal
health care programs. Through our experience in resolving Protocol
matters, we identified areas where additional guidance would be
beneficial to the provider community and would improve the efficient
resolution of Protocol matters. Specifically, we issued three Open
Letters to Health Care Providers to address some of these issues.
First, in 2006 we announced an initiative to encourage disclosure of
conduct creating liability under OIG's anti-kickback and physician
self-referral law CMP authorities. In 2008, we issued additional
guidance and requirements for Protocol submissions to increase the
efficiency of the Protocol, including new requirements for the initial
submission and specific time commitments from the provider. This Open
Letter also announced the presumption of not requiring a compliance
agreement as part of settling a cooperative and complete disclosure.
Finally, in 2009, we stated we would no longer accept disclosure of a
matter into the Protocol that involved only liability under the
physician self-referral law in the absence of a colorable anti-kickback
violation. We also announced a minimum $50,000 settlement amount for
kickback-related submissions.
After over a decade of experience in resolving Protocol
disclosures, we are considering revising the Protocol to provide
additional guidance. We are soliciting comments, recommendations, and
other suggestions from concerned parties and organizations on how best
to revise the Protocol to address relevant issues and to provide useful
guidance to the health care industry.
[[Page 36282]]
Dated: June 8, 2012.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2012-14585 Filed 6-15-12; 8:45 am]
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