May 12, 2008
In welcome news to clinical laboratories and other providers who opt to resolve potential federal fraud issues by using the self-disclosure protocol, the HHS Office of Inspector General has announced that it generally will not require them to enter into a corporate integrity agreement.
The OIG says that it will recognize as "effective compliance measures" the following: a complete good-faith disclosure of the conduct in question, timely response to the OIG’s requests for further information, and performance of an accurate audit.
The self-disclosure protocol, which the OIG introduced in 1998, offers guidance to health care providers who voluntarily disclose federal health care compliance issues that the provider believes potentially violate federal criminal, civil, or administrative laws for which exclusion or civil monetary penalties are authorized.
In an open letter to providers on April 15 spelling out the latest refinements to the protocol, Inspector General Daniel R. Levinson said that, to improve the process, the initial submission must contain:
- A complete description of the conduct being disclosed.
- A description of the provider’s internal investigation or a commitment as to when it will be completed.
- An estimate of the damages to federal health care programs and how the figure was calculated (or a commitment as to when the estimate will be completed).
- A statement of the laws potentially violated by the conduct.
The above information must be included in addition to the basic information described in the self-disclosure protocol. Further, Levinson said, the provider must be in a position to complete the investigation and the damages assessment within three months after being accepted into the protocol.
Levinson pledged that his office will respond promptly to self-disclosures and give priority to resolving the issues raised. "To that end, we have streamlined our internal process for resolving these cases."
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May 12, 2008 - Table of Contents
