CCH® Healthcare Compliance — 04/29/08

OIG refines self-disclosure protocol requirements

Providers that make appropriate disclosures under the Office of Inspector General's (OIG's) self-disclosure protocol (SDP) will have the benefit of a presumption against imposition of corporate integrity agreements (CIAs) and certification of compliance agreements (CCAs), according to an open letter to health care providers issued by Inspector General Daniel R. Levinson on April 15, 2008. The letter, which refines the requirements for participation in the SDP, “emphasizes the Office of Inspector General's(OIG's) commitment to streamline its internal process for self-disclosure case resolution,” the OIG said in a related press release.

The SDP provides guidance to health care providers that voluntarily disclose fraudulent conduct affecting Medicare, Medicaid, and other federally funded health care programs, including compliance issues that the provider believes potentially violate federal criminal, civil, or administrative laws for which exclusion or civil monetary penalties may be imposed.

CIAs and CCAs. According to the open letter, providers that disclose in good faith, cooperate with the OIG, and promptly provide requested information will not be required to enter into CIAs or CCAs with the OIG.

“A provider's submission of a complete and informative disclosure, quick response to OIG's requests for further information, and performance of an accurate audit are indications that the provider has adopted effective compliance measures,” Levinson explained. “We believe that this presumption in favor of not requiring a compliance agreement appropriately recognizes the provider's commitment to integrity and also advances our goal of expediting the resolution of self-disclosures,” he added.

Additional requirements. For a provider to participate in the SDP and benefit from the presumption in favor of not requiring CIAs and CCAs, the initial submission to the OIG must contain:

  1. a complete description of the conduct being disclosed;
  2. a description of the provider's internal investigation or a commitment regarding when it will be completed;
  3. an estimate of the damages to the federal health care programs, along with an explanation of the methodology used to calculate the estimate, or a commitment regarding when the estimate will be completed; 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 three months after acceptance into the SDP.

Levinson emphasized in the open letter that the “refinements to OIG's SDP process are intended to provide an opportunity for providers to work with OIG to more efficiently and fairly resolve matters appropriately disclosed under the SDP….[T]his approach benefits both disclosing providers and the [g]overnment and furthers our efforts to strengthen the integrity of the [f]ederal health care programs.”

OIG Press Release, April 15, 2008; Open Letter to Health Care Providers, April 15, 2008, Health Care Compliance Reporter ¶530,666.

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