On March 28, 2017, the Centers for Medicare and Medicaid Services (CMS) posted a revised Voluntary Self-Referral (Stark) Disclosure Protocol (SRDP), which replaces the prior version of the protocol. Under the Affordable Care Act (ACA), providers generally must return overpayments within 60 days after identification (the 60 Day Rule), and the SRDP is one of the primary tools that providers can use to return overpayments caused by an actual or potential violation of the Stark Law. The revised protocol now requires information to be submitted on detailed Disclosure, Physician Information, and Financial Analysis Worksheet forms, along with a Certification. A supplemental cover letter is optional. While these forms are required for disclosures beginning on June 1, 2017, CMS encourages providers to begin using the new SRDP forms immediately.
The newly revised SRDP contains some significant changes from the initial protocol (although it is very similar to the draft version that was proposed last year, as described in our prior blog post on May 12, 2016). CMS proposed these changes in part to ensure the lookback requirements under the SRDP are consistent with the 6-year lookback period established by the 60 Day Rule. The initial version of the SRDP had only required a 4-year lookback period.
CMS also attempted to streamline the self-disclosure process by requiring the use of the following standardized forms: (1) the SRDP Disclosure Form; (2) the Physician Information Form; and (3) the Financial Analysis Worksheet. If the noncompliant financial relationship includes more than one physician, the disclosure must include a separate Physician Information Form for each physician involved.
Another key difference between the 2010 protocol and the revised SRDP is a new requirement to report the “Pervasiveness of Noncompliance.” This section contains detailed instructions and examples on reporting how “common or frequent the disclosed noncompliance was in comparison with similar financial relationships between the disclosing party and physicians.”
The new Financial Analysis Worksheet provides specific instructions on the nature and format of the financial information that must be submitted with the self-disclosure. Providers must submit data in an Excel-compatible worksheet including a text box describing the methodology used to determine the overpayment, and indicating whether estimates were used, and, if so, how the estimates were calculated. Overall, the information to be reported in the Financial Analysis Worksheet is quite comprehensive and detailed.
The revised SRDP emphasizes the obligation to update a disclosure if the disclosing party subsequently files for bankruptcy, changes its designated representative, or goes through a change of ownership. Under these circumstances, CMS must be notified within 30 days.
It is notable that, unlike the original version, the revised protocol states that the actual amount of remuneration between the parties does not have to be disclosed unless otherwise requested. In addition, the new SRDP appears to limit the factors that CMS may consider in determining the settlement amount to some extent. The 2010 protocol stated that CMS could consider litigation risk and the financial position of the disclosing party in determining the settlement amount, but the new SRDP eliminates these factors. The new protocol only notes that in reducing the amount owed, CMS may consider: (1) the nature and extent of the improper conduct; (2) the timeliness of the disclosure; and (3) the cooperation in providing additional related information.
The SRDP frequently has advantages for providers who choose to make a disclosure and often results in beneficial settlements. Historically, the review and resolution process has been extremely slow. The pace seems to have picked up over the past year, and standardizing the content of the self-disclosure may help CMS further expedite its review. Compiling and organizing the additional detailed information under the new SRDP will likely increase the burden on providers. Nevertheless, it is critical that providers closely review the new protocol to ensure that their submissions are fully compliant with the revised SRDP requirements before submitting their disclosure.