On June 18, 2012, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a request for recommendations for revising and updating OIG’s Provider Self-Disclosure Protocol. Specifically, OIG is considering revising the Protocol to provide additional guidance and is soliciting comments and recommendations on how best to revise the Protocol to address relevant issues and to provide useful guidance to the health care industry. Comments are due by August 17, 2012.
Provider Self-Disclosure Protocol
In 1998, OIG published the Provider Self-Disclosure Protocol to establish a process for health care providers to disclose potential fraud involving federal health care programs. The Protocol provides guidance on how to 1) investigate the conduct, 2) quantify damages, and 3) report the conduct to OIG to resolve a provider’s liability exposure under OIG’s Civil Monetary Penalty (CMP) authorities. During the past 14 years, OIG has resolved more than 800 disclosures.
OIG has issued three Open Letters regarding the Protocol in 2006, 2008, and 2009. In 2006, OIG announced an initiative to encourage disclosure of conduct creating liability under the Anti-Kickback Statute and Physician Self-Referral Law. In 2008, OIG issued additional guidance and requirements for Protocol submissions, including new requirements for the initial submission and specific time commitments from providers. The 2008 guidance also announced the presumption that OIG would not require a compliance agreement as part of settling a cooperative and complete disclosure.
Finally, in 2009, OIG stated it 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 Statute violation. OIG also announced a minimum $50,000 settlement amount for kickback-related submissions.
This request for comments is an opportunity for health care providers, suppliers, and plans to voice their concerns and offer suggestions to change the current Provider Self-Disclosure Protocol. As important stakeholders in the health care industry, input from health care providers, suppliers, and plans would help OIG identify changes to improve and streamline existing guidance regarding program integrity.
Some possible areas to address in comments include:
Persons interested in this opportunity can collaborate with health care counsel and public policy professionals to timely prepare comments for consideration by OIG. Comments are due by August 17, 2012.
Nathaniel M. Lacktman
Maria E. Gonzalez Knavel
Jonathan P. Kilman
Heidi A. Sorensen
Lawrence W. Vernaglia
Judith A. Waltz
San Francisco, California