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DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General
Washington, D.C. 20201
An Open Letter to Health Care Providers
April 15, 2008
Since the inception of the Office of Inspector General (OIG) Provider Self-Disclosure Protocol
(SDP) in 1998, OIG has encouraged the health care provider community to help ensure the integrty
ofthe Federal health care programs by voluntarily disclosing self-discovered evidence of potential
fraud. In this spirit of collaboration, we have responded to the provider communty's suggestions
in the past for ways to improve the SDP. In my 2006 Open Letter, for example, I encouraged
providers to disclose improper arangements under the physician self-referral (Stark) law (42 D.S.C.
� 1395nn) and committed to settling liability under OIG's authorities generally for an amount near
the lower end of the damages continuum, i.e., a multiplier ofthe value of the financial benefit
conferred.
The SDP has been an important component of our shared commitment to promote integrty in the
Federal health care programs through effective compliance programs. To date, OIG has retued
approximately $120 milion to the Medicare Trust Fund through the SDP and paricipating providers
have avoided the costs and disruptions often associated with a Governent-directed investigation.
However, we have identified additional opportties to improve the SDP process. This Open Letter
discusses certain refinements and clarfications to OIG's policies that we believe wil increase the
efficiency of the SDP and benefit providers who self-disclose.
To improve the disclosure process, we have concluded that the initial submission must contain the
following information: (1) a complete description ofthe conduct being disclosed; (2) a description
ofthe provider's internal investigation or a commitment regarding when it wil be completed; (3) an
estimate of the damages to the Federal health care programs �nd the methodology used to calculate
that figue or a commitment regarding when the provider will complete such estimate; and (4) a
statement of the laws potentially violated by the conduct. This information must be included in
addition to the Basic Information described in the SDP. The provider must be in a position to
complete the investigation and damages assessment within 3 months after acceptance into the SDP.
In addition, we have found from experience that the success ofthe SDP is contingent on OIG
responding to the self-disclosure promptly and makng resolution of the matter a priority. To that
end, we have streamlined our internal process for resolving these cases. In tur, we expect full
cooperation from disclosing providers durng the verification of the matter disclosed. As I advised in
my prior Open Letter, we wil remove providers from paricipation in the SDP unless they disclose in
good faith and timely respond to OIG's requests for additional information.
The efficiency ofthe SDP also depends on the provider's good faith determination that the matter
implicates potential fraud against the Federal health care programs, rather than merely an
overpayment. The SDP is intended to facilitate resolution of matters that potentially violate Federal
criminal law, civil law, or administrative laws for which exclusion or civil monetar penalties are
authorized. Disclosures that are characterized as mere billing errors or overpayments are not
appropriately addressed by the SDP and should be submitted directly by the provider to the
appropriate claims-processing entity, such as the Medicare contractor.
A provider's submission of a complete and informative disclosure, quick response to OIG's requests
for fuher information, and performance of an accurate audit are indications that the provider has
adopted effective compliance measures. Accordingly, when we negotiate the resolution ofOIG's
applicable administrative monetar and permissive exclusion authorities in exchange for an
appropriate monetar payment, we generally will not require the provider to enter into a Corporate
Integrty Agreement or Certification of Compliance Agreement. We believe that this presumption in
favor of not requiring a compliance agreement appropriately recognzes the provider's commitment
to integrty and also advances our goal of expediting the resolution of self-disclosures.
These refinements to OIG's SDP process are intended to provide an opportty for providers to
work with OIG to more effciently and fairly resolve matters appropriately disclosed under the SDP.
I believe that this approach benefits both disclosing providers and the Governent and fuhers our
efforts to strengthen the integrty ofthe Federal health care programs. I look forward to continuing
our mutual efforts to promote compliance.
Sincerely,~~~
Danel R. Levinson
Inspector General
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