OIG Seeks Comments on Changes to Provider Self-Disclosure Protocol

25 June 2012 Publication
Authors: Nathaniel M. Lacktman Maria E. Gonzalez Knavel Lawrence W. Vernaglia Judith A. Waltz

Legal News Alert: Health Care

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:

  • The relationship between the 60-Day Refund Rule and use of the Self-Disclosure Protocol. For example, how a provider’s timely report to OIG under the Protocol satisfies the reporting requirements under the 60-Day Refund Rule. 
  • Clearer explanation of which types of disclosures are appropriate for OIG and which disclosures should be submitted to Medicare Administrative Contractors using the voluntary refund process. 
  • Guidance regarding the scope of internal investigations and, particularly, the appropriate length of time for a look-back period. 
  • Guidance on performing a self-assessment for disclosures involving employment of excluded persons. 
  • Eliminating repetitive or outdated questions, and updating the list of topics to be addressed in the initial disclosure, report of the internal investigation, and the self-assessment.

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.

Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and colleagues. If you have any questions about this Alert or would like to discuss the topic further, please contact your Foley attorney or:

Nathaniel M. Lacktman
Tampa, Florida

Maria E. Gonzalez Knavel
Milwaukee, Wisconsin

Jonathan P. Kilman
Tallahassee, Florida

Heidi A. Sorensen
Washington, D.C.

Lawrence W. Vernaglia
Boston, Massachusetts

Judith A. Waltz
San Francisco, California

Related Services