On September 23, 2010, the Centers for Medicare and Medicaid Services (CMS) posted the longawaited CMS Voluntary Self-Referral Disclosure Protocol (SRDP) which was required by The Affordable Care Act (ACA) enacted on March 23, 2010.
The SRDP establishes a process available to all health-care providers and suppliers to self-disclose and resolve only actual or potential violations of the Stark Law. The SRDP is distinct from the Stark Law advisory opinion process and also cannot be used to resolve conduct that may implicate other federal, criminal, civil or administrative laws, such as the federal anti-kickback statute.
Importantly, as required by the ACA, under the SRDP CMS will have the authority to reduce the amount health-care providers owe for Stark Law violations. The ACA also instructs that in doing so, CMS is to consider the following factors:
- The nature and extent of the improper or illegal practice
- The timeliness of the disclosure
- The cooperation in providing additional information related to the disclosure
- Such other factors as the Secretary may consider appropriate.
The SRDP clarifies that a provider or supplier may not disclose an actual or potential violation of the Stark Law under the SRDP and at the same time seek a Stark Law advisory opinion for conducting the same arrangement concurrently. Likewise, the SRDP cannot be used to obtain a CMS determination regarding whether a Stark Law violation has occurred. Rather, parties self-disclosing under the SRDP should expect to resolve overpayment liability resulting from the actual or potential Stark Law violation. In addition, the SRDP is available to a provider or supplier that may already be subject to government inquiry, such as an investigation, audit or in connection with other routine oversight activities. However, CMS cautions that all self-disclosures must be made in good faith and not in an attempt to circumvent an ongoing inquiry.