CMS Releases Revised Voluntary Self-Referral Disclosure Protocol (SRDP).

The Centers for Medicare and Medicaid Services (CMS) recently released their revised Voluntary Self-Referral Disclosure Protocol (SRDP).  The SRDP enables providers of services and suppliers to self-disclose actual or potential violations of the federal physician self-referral statute (the Stark Law).  The Affordable Care Act (ACA) required CMS, in cooperation with the Department of Health and Human Services (HHS) Office of Inspector General (OIG), to establish the Medicare SRDP which sets forth a process for self-disclosure.  The CMS protocol was also designed to facilitate the resolution of actual or potential violations and resolve overpayment liabilities.  CMS recently revised the SRDP to streamline the process and reduce the burden on those submitting disclosures.  Effective June 1, 2017, the revised SRDP provides a streamlined and standardized format for disclosing actual or potential violations.  A further significant change arises from the final CMS overpayment rule issued in 2016.  The overpayment rule establishes a six-year “lookback” period for the reporting and returning of overpayments from the date that the disclosing party submitted the SRDP disclosure.  This CMS rule goes into effect in 2017.

There has been a steady growth in the number of cases settled through the SRDP process.  In 2011, only three disclosures were settled in the aggregate amount of $709,060.  This number has grown to 102 settlements amounting to $6,913,988 in 2016.  To date, there have been a total of 233 settlements totaling an aggregate amount of $23,209,222.  Further reports state that 322 providers had submitted self-disclosures to the SRDP as of Sept. 26, 2016, with settlement amounts ranging from $60 to $579,000.

Compliance Officers, providers and suppliers should note the increased enforcement focus on the Stark and Anti-Kickback laws.  When encountering potential Stark law violations, they should also consider that many of the self-disclosed violations submitted under the SRDP do not result in settlements.

Advice for those considering an SRDP includes the following:

1. Ensure that the matter truly involves a Stark law violation. In the past, CMS has forwarded some matters to the OIG as they were clearly violations of the Anti-Kickback Statute.
2. Clearly lay out all of the required information before the SRDP is submitted.
3. Consider repaying the Medicare Contractor directly and avoiding the SRDP process, if the actual or potential violation involves a small monetary amount.
4. Avoid making a referral to CMS, if the provider or organization is not prepared to accept an offer from CMS.
5. Anticipate and prepare for the possibility that the SRDP may become public.
6. Prepare an “element-by-element” analysis of the arrangement that outlines the satisfied and non-satisfied Stark law elements.
7. Prepare and organize all factual and legal arguments relating to the potential or alleged violation before submission. Accordingly, determine whether the arrangement compensation varied with the volume or value of referrals, and if so, explain why.

The CMS SRDP can be found at:

https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Self_Referral_Disclosure_Protocol.html.