The Centers for Medicare & Medicaid Services (CMS) recently announced updates to the Stark Law voluntary self-referral disclosure protocol (the “Protocol”), including revisions to streamline Protocol submissions. The Protocol process allows providers and suppliers to report certain violations under the Ethics in Physician Self-Referrals Law (the “Stark Law”) by submitting information to CMS about actual or potential Stark Law violations. The decision to utilize the Protocol and the complete process of a voluntary self-disclosure are both complex and warrant careful and detailed consideration by a healthcare provider and qualified legal counsel.
The revised Protocol process introduces three (3) key changes designed to reduce filing burdens by permitting providers to:
Use a single Group Practice Information Form to report noncompliance with the Stark Law’s group practice definition, rather than completing separate forms for each individual physician in a group that had a prohibited referral due to such noncompliance; Submit a single Physician Information Form to disclose multiple compensation arrangements with different physicians who each “stand in the shoes” of the practice organization that is party to the noncompliant arrangement; and Electronically submit an entire Protocol submission, removing the requirement to submit a hard copy of the signed certification statement. Providers are required to submit all information necessary for CMS to analyze an actual or potential violation of the Stark Law. In order to utilize the Protocol, providers must use the forms included in the collection instrument most recently approved by the Office of Management and Budget as of December 2022, entitled CMS Voluntary Self-Referral Disclosure Protocol form (the “Disclosure Forms”). It is important to note that earlier versions of these forms cannot be used.
Beginning March 1, 2023, except as provided below regarding disclosures related to the failure of a physician-owned hospital or rural provider to disclose physician ownership on any public website and in any public advertisement, a complete disclosure generally requires the following:
For disclosures of noncompliance arising from the failure of a physician practice to qualify as a group practice, the self-disclosure generally must include: (1) the Disclosure Forms; (2) the Group Practice Information Form; (3) a Financial Analysis Worksheet; and (4) an acceptable certification.
For disclosures of all remaining types of noncompliance (i.e., disclosures of noncompliance other than (a) the failure of a physician-owned hospital or rural provider to disclose physician ownership on any public website and in any public advertisement, or (b) noncompliance arising from the failure of a physician practice to qualify as a group practice), the self-disclosure generally must include: (1) the Disclosure Forms; (2) Physician Information Form(s); (3) a Financial Analysis Worksheet; and (4) an acceptable certification.
In sum, CMS’ updates to the Protocol are designed to streamline the process of reporting and resolving noncompliance with the Stark Law and are consistent with CMS’ broader goal of facilitating Stark Law compliance. It is yet to be seen whether these updates will have the intended effect of reducing the burden on providers, particularly as it relates to common circumstances for disclosures such as noncompliance with the group practice definition and hospital submissions involving arrangements with physician organizations.