On May 6, 2016, CMS published in the Federal Register a request for comments on proposed revisions to the information to be collected pursuant to the CMS Voluntary Self-Referral (Stark) Disclosure Protocol (SRDP). The proposed revisions introduce a new SRDP submission form and update the requirements of the SRDP to reflect recent regulations that require providers to self-disclose overpayments going back up to six years, when appropriate. CMS is requesting comments on the revised SRDP by July 5, 2016.
The current SRDP requires a four year lookback period. However, on February 12, 2016, CMS published a final rule on the reporting and returning of overpayments (previously analyzed here) that established a six year lookback period, and the SRDP is being revised to align with this new requirement.
CMS also stated that it is taking this opportunity to streamline and simplify the self-disclosure process by issuing a Checklist and certain required forms that must be used for SRDP submissions. The required items include the SRDP Disclosure Form, Physician Information Form(s) (one for each physician included in the disclosure), the Financial Analysis Worksheet (submitted in Microsoft Excel-compatible format), and a Certification.
While most of the information required for an SRDP submission is substantively the same under the new template as under the existing protocol, CMS is making some changes in addition to the extension of the lookback period. Most notably, the proposed form includes a section on "Pervasiveness of Noncompliance," in which disclosing parties must report on how common or frequent the type of noncompliance is in comparison to its similar financial relationships with other physicians. While not required under the current SRDP, providers may find it beneficial to furnish this data. (We have often recommended that our clients provide this type of information because it can help demonstrate that the noncompliance is relatively limited when considered in the context of the disclosing provider’s many other financial relationships with physicians.)
In addition, the proposed Financial Analysis Worksheet provides more specific instructions on the types of information that must be included as part of the financial analysis and how that information must be presented. As a result, the proposed template is more likely to expedite the self-disclosure process for CMS (once it has received a disclosure) than for providers (as they are preparing a self-disclosure).