Beginning on June 1, 2017, health care providers of services and suppliers must submit all information necessary for the Centers for Medicare and Medicaid Services (“CMS”) to analyze actual or potential violations of the federal physician self-referral law (the “Stark Law”) using approved forms designed to streamline the CMS Voluntary Self-Referral Disclosure Protocol (the “SRDP”). If you are currently working on a self-disclosure filing for CMS, you must convert that disclosure to this new format or risk CMS rejecting the disclosure in its entirety. The new forms, contained within Form CMS-10328 available here, must be used for all voluntary Stark Law self-disclosures submitted on or after June 1, 2017, except disclosures by physician-owned hospitals and rural providers regarding a failure to disclose physician ownership on the provider’s website or in any public advertisement.[1]

Under the revised SRDP process, the voluntary self-disclosure will now consist of the following components: (1) the SRDP Disclosure Form, which provides CMS with information about the disclosing party and their compliance programs; (2) the Physician Information Form(s) for each physician included in the disclosure which provides details of the noncompliance financial relationship(s) between the physician and the disclosing party; (3) the Financial Analysis Worksheet, which must be submitted in Microsoft Excel format and quantifies the overpayment for each physician included in the disclosure who made referrals in violation of the Stark Law physician information form, which is required for the physician(s) identified in the disclosure; and (4) the signed certification of the disclosing party’s authorized individual attesting to the truthfulness of the information contained in the disclosure.

Although several aspects of the SRDP mirror the prior narrative format of SRDP filings, there are some significant differences, including: (1) an affirmative obligation to inform CMS by email if the disclosing party files for bankruptcy or undergoes a change of ownership or change of designated representative; (2) information requirements in the SRDP Disclosure Form about the pervasiveness of the noncompliance when compared with similar financial relationships between the disclosing party and physicians; (3) individualized physician analyses by way of the new Physician Information Form, meaning disclosing parties can no longer lump together various problematic physician relationships into a single analysis (i.e., if you have ten physicians that stand in the shoes of their practice entity with the problematic financial relationship, you must submit ten Physician Information Forms); (4) the removal of the requirement to submit information regarding the financial benefit of a noncompliant relationship to the applicable physician(s); and (5) a checkbox system of identifying elements of financial relationships not complied with in addition to narratives need only to address the noncompliant elements of an applicable Stark Law exception.