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OIG Solicits Comments and Recommendations for Revising Self-Disclosure Protocol

On Monday, June 18th, the Office of Inspector General (OIG) published a notice that it intends to update its Provider Self-Disclosure Protocol (Protocol), through which health care providers can disclose potential fraud and resolve liability under the OIG’s civil monetary penalty authority.  The OIG also solicited comments and recommendations about how to revise the Protocol to “address relevant issues” and to “provide useful guidance to the health care industry.”  The request for comments is very general, and it didn't limit input to any specific area.

The OIG published the Protocol in 1998.  It has since issued additional guidance on the Protocol in three Open Letters to Health Care Providers, including more detail about the required contents of a provider’s disclosure to OIG.  Of particular note, in its 2009 Open Letter, the OIG explained that it would no longer accept disclosure of a violation of the physician self-referral law (the Stark Law) without a “colorable” violation of the Anti-kickback Statute.  Violations of the Stark Law can now be disclosed to the Centers for Medicare & Medicaid Services (CMS) through a separate Voluntary Self-Referral Disclosure Protocol, which is similar to OIG’s Protocol.

Since 1998, the OIG has resolved over 800 disclosures and recovered over $280 million to federal health care programs.  Although it may have specific changes to the Protocol in mind, the OIG is seeking input from providers and other interested parties.  Providers who have disclosed conduct to the OIG through the Protocol, resolved a disclosed matter, or are otherwise interested, should consider commenting.  Providers may wish to comment on the process to resolve a disclosure, including what worked well or proved difficult, or on areas where they need additional guidance.  The potential for overlapping reporting obligations for overpayments is one possible topic.  CMS has issued a proposed rule addressing the 60-day deadline for returning Medicare and Medicaid overpayments enacted as part of the Affordable Care Act (ACA) (the proposed rule is discussed in more detail in a Mintz Levin advisory).  Under the proposed rule, providers and suppliers would report overpayments to the appropriate Medicare contractors using the existing voluntary refund process, which will be renamed the “self-reported overpayment refund process.”  Because the different mechanisms employed by CMS and the OIG may create duplicate obligations to report overpayments, CMS proposed that providers and suppliers who report overpayments through the Protocol should not also report and return overpayments through the overpayment refund process.

Comments on the Protocol are due by August 17, 2012.

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Brian P. Dunphy

Member / Co-Chair, Health Care Enforcement Defense Practice

Brian P. Dunphy is a member of the Health Care Enforcement & Investigations Group at Mintz. He defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act. Brian also handles commercial health care litigation.