Beginning June 1, 2017, health care providers and suppliers who wish to voluntarily disclose actual or potential violations of the Stark Law must follow the new process recently finalized by the Centers for Medicare and Medicaid Services (CMS).

The Stark Law prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare or Medicaid to an entity with which the physician, or an immediate family member, has a financial relationship, unless an exception applies. The Stark Law also prohibits billing for DHS provided as a result of a prohibited referral. The 2010 Patient Protection and Affordable Care Act (ACA) required the Department of Health and Human Services (HHS) to establish a self-referral disclosure protocol (SRDP) to set forth a process for health care providers and suppliers to voluntarily self-disclose actual or potential violations of the Stark Law.

Previously, health care providers and suppliers submitted self-disclosures of actual or potential Stark violations to CMS via letter. Beginning June 1, 2017, providers and suppliers must submit all information necessary for CMS to analyze the actual or potential Stark violation via a new collection instrument (Form CMS-10328), which includes a SRDP Disclosure Form, a Physician Information Form for each physician included in the disclosure, a Financial Analysis Worksheet, and a certification. Disclosing parties are permitted to submit an optional cover letter with any additional information the party believes may be relevant to CMS’s review. The SRDP and the required forms are located here.

It’s worth noting the new SRDP does not apply to physician-owned hospitals, which are required to continue reporting noncompliant conduct via a separate process, available here. Additionally, health care providers and suppliers who wish to self-report actual or potential fraud unrelated to the Stark Law should continue to use the self disclosure protocol set forth by the HHS Office of the Inspector General (OIG) at https://oig.hhs.gov/compliance/self-disclosure-info/protocol.asp.