On March 27, 2017, CMS posted a new set of standardized forms for disclosure of potential violations of the Stark Law under the Self-Referral Disclosure Protocol (“SRDP”).  The forms instruct disclosing entities to follow certain new requirements, including requirements to update CMS upon certain changes to the disclosing entity and to file separate disclosures for each Medicare-enrolled entity.  The new forms obligate disclosing entities to fill in information into the blank fields of a pdf file in order to standardize SRDP submissions.  Many of the fields are prefaced with detailed discussion of the information that should be included in the submission based on the type of noncompliance that is being disclosed.  The new forms will become mandatory on June 1, 2017. 

The SRDP is a process that enables providers to self-disclose actual or potential violations of the federal physician self-referral statute commonly referred to as the “Stark Law.”  The SRDP was created in 2010 by section 6409 of the Affordable Care Act. 

The previous version of the SRDP guidance (now identified by CMS as “retired”) required the inclusion of certain information in each submission, without the use of a standardized submission form.  The new set of forms standardizes the submission process by providing a single pdf file with blank fields to be completed by the disclosing party. 

The new set of forms includes four mandatory components:

• SRDP Disclosure Form.  This form contains information about the disclosing party, including any history of abuse, pervasiveness of noncompliance, and steps to prevent future noncompliance.
• Physician Information Form.  This form, which must be submitted for each physician included in the disclosure, requires details regarding the noncompliant financial relationship between the physician and the disclosing party.
• Financial Analysis Worksheet.  This worksheet quantifies the overpayment for each physician included in the disclosure who made referrals in violation of the Stark Law.  The worksheet must be submitted in Microsoft Excel-compatible format.
• Certification.  A certification must be signed by the disclosing party or, in the case of an entity, its chief executive officer, chief financial officer, or another authorized individual.

In addition to these four mandatory components, the disclosing party may submit a cover letter containing any additional information that is relevant to CMS’s evaluation of the disclosure.

The forms are intended to provide a more detailed discussion regarding the information that is sought by CMS.  As a new obligation, the forms require the disclosing party to inform CMS by email within 30 days of the occurrence of the following changes to the disclosing party: filing for bankruptcy, undergoing a change of ownership, or changing the designated representative.  Additionally, CMS instructs in the forms that, if multiple entities from a single network or system are involved, each entity that is separately enrolled in Medicare must submit a separate disclosure. 

The new SRDP forms are available here.