Publications: CMS Voluntary Stark Law Self-Referral Disclosure Protocol

On September 23, 2010, the Centers for Medicare and Medicaid Services ("CMS") released the Self-Referral Disclosure Protocol ("SRDP") enacted by Section 6409 of the Patient Protection and Affordable Care Act ("PPACA"). The SRDP sets forth the process by which a provider of service or a supplier ("disclosing party") may voluntarily self-report actual or potential violations of the physician self-referral statute ("Stark Law").

Under the SRDP, a disclosing party may disclose actual or potential violations of the Stark Law to CMS in return for potential reductions in the amount owed to the government. CMS will review the circumstances surrounding the disclosed matter to determine an appropriate resolution, including entrance into a settlement agreement or removal of the disclosing party from the SRDP process.

According to the SRDP, disclosures must pertain solely to actual or potential Stark Law violations. The PPACA explicitly differentiates the SRDP from the Stark Law advisory opinion process, which process addresses existing arrangements or ones into which the requestor specifically plans to enter. CMS prohibits a disclosing party from concurrent disclosure through the SRDP and advisory opinion process. Furthermore, as the SRDP is intended for violations of the Stark Law alone, circumstances that implicate liability under other federal criminal, civil, or administrative laws (e.g., the Anti-Kickback Statute) should be disclosed under the separate Office of the Inspector General (OIG) Self-Disclosure Protocol.

Disclosures to CMS pursuant to the SRDP must be in both electronic and paper format, and must include a significant amount of information including identification of the disclosing party, the matter being disclosed, a complete Stark Law analysis of same, a financial analysis of the amounts owed to the government and other key information. No payment should accompany the disclosure, although the government encourages providers to deposit potential penalty amounts in an interest bearing escrow account.

CMS will then review and verify information submitted. The length of the CMS verification process depends largely on the quality and thoroughness of the disclosure to CMS. During this process, CMS requires access to all financial statements, notes, disclosures and all other supporting documents. Upon conclusion of the CMS verification process, if a settlement agreement is pursued, CMS may exercise its authority to reduce the disclosing party's amount owed. CMS explicitly states, however, that it is under no obligation to reduce any amounts due and owing.

Finally, while we now have the disclosure protocol, the industry continues to struggle with disclosure decision-making with respect to more complex situations and the related interplay between and among Stark exceptions and related "grace" provisions (e.g., reliance on an inadvertent vs. advertent signature delay provision). Close attention to all relevant provisions will be critical to any informed disclosure decision-making.

A complete copy of the SRDP may be found by clicking here.