[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4152-01-P