The Centers for Medicare & Medicaid Services (CMS) recently announced updates to the voluntary self-referral disclosure protocol (SRDP), including revisions to streamline SRDP submissions. The SRDP process allows providers and suppliers to report certain violations under the Physician Self-Referral Law, commonly known as the Stark Law, by submitting information to CMS about actual or potential Stark Law violations. The decision to utilize the SRDP and the complete process of an SRDP disclosure are both complex and warrant careful and detailed consideration by a healthcare provider and their counsel.
The revised SRDP process introduces three key changes designed to reduce burdens of filing on self-disclosing providers by permitting such 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 SRDP 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 SRDP, providers must use the forms included in the collection instrument most recently approved by the Office of Management and Budget (OMB) as of December 2022, entitled CMS Voluntary Self-Referral Disclosure Protocol (SRDP). 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 SRDP Disclosure Form; (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 SRDP Disclosure Form; (2) Physician Information Form(s); (3) a Financial Analysis Worksheet; and (4) an acceptable Certification.
In sum, CMS’ updates to the SRDP aim 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 organization.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in navigating regulation of the corporate practice of medicine. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or email@example.com.