Posted 18 June 2012

Agency Looks to Overhaul Voluntary Fraud Reporting Program

It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years.

What happens next, explains the US Department of Health and Human Services' Office of the Inspector General (OIG), is what makes a fourteen-year-old program worth continuing.

In a Federal Register posting on 18 June, OIG said it wants to keep running a program responsible for recouping more than a quarter of a billion dollars in fraud thanks to incentives that give partial amnesty in return for reporting fraud and cooperating with OIG.

The program, called the Provider Self-Disclosure Protocol, reduces civil money penalties normally required of guilty companies. While OIG says its recovered dollars speak to the Protocol's success, it has previously identified and provided guidance in areas where additional information "would improve the efficient resolution of Protocol matters."

Now, OIG says it wants to revisit the Protocol in its entirety. "After over a decade of experience in resolving Protocol disclosures, we are considering revising the Protocol to provide additional guidance," explained OIG. "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."

Comments on the Protocol will be accepted until 17 August, after which time OIG will likely compose a draft guidance for release.

Read more:

OIG - Solicitation of Information and Recommendations for Revising OIG's Provider Self-Disclosure Protocol