Self-Referral Disclosure Protocol

October 13, 2010, 2:34 PM

The Patient Protection and Affordable Care Act (PPACA) includes a few revisions to the Stark Law and related regulations. One such change is to grant the secretary of Heath and Human Services (the Secretary) the authority to consider reduced sanctions for providers and suppliers who self disclose violations of the Stark Law. Prior to the PPACA there was no provision allowing for providers and suppliers to self disclose such violations.

On September 23, 2010, the Centers for Medicare and Medicaid Services (CMS) released its Medicare self-referral disclosure protocol (SRDP). The Secretary has discretion to consider a range of factors in determining whether to reduce sanctions against an entity that has decided to self report in accordance with the SRDP. Among the factors that the Secretary may consider are nature of the violation, the financial situation of the self disclosing party, the timeliness of the self disclosure, and the litigation risk associated with the disclosed violation.

The SRDP requires that all self disclosures be submitted electronically, along with hard copies sent to CMS, and provides for specific information that must be included in any such self disclosure. The required content of a self disclosure under the SRDP includes, without limitation, identifying information (i.e. name, address, NPI number) for the disclosing party, description of the violation, legal analysis of why the disclosing party believes a violation has occurred, how the violation was discovered, disclosure of past history of violations, and disclosure of any compliance programs that the disclosing party had in place at the time of the violation.

To review all of the terms and requirements with respect to self disclosure of Stark Law violations, the SRDP can be accessed at http://www.cms.gov/PhysicianSelfReferral/Downloads/6409_SRDP_Protocol.pdf. --Aaron J. Ambrose