On March 28, the Centers for Medicare & Medicaid Services (CMS) revised the procedures and posted new forms for its Voluntary Self-Referral Disclosure Protocol (SRDP). The SRDP is a mechanism established pursuant to the Affordable Care Act for health care providers and suppliers to facilitate settlement of violations of the physician self-referral law (Stark Law).
Under the Stark Law, physicians (or their immediate family members) who have a financial relationship with an entity are prohibited from making referrals to that entity for certain designated health services (DHS) that are payable by Medicare, unless an exception applies. In addition, the entity is prohibited from presenting (or causing to be presented) claims to Medicare, or another individual, entity or third-party payer, for the services referred in violation of the Stark Law. Violations of the Stark Law can result in monetary penalties of $10,957 to $21,916 per claim submitted.
Using the SRDP, the Department of Health and Human Services has the authority to reduce the amount due and owing for violations of the Stark Law. Any health care provider or supplier (called a “Disclosing Party”) can submit a self-disclosure under the SRDP. The disclosure has to be made in good faith and cannot attempt to circumvent an ongoing government inquiry; however, a Disclosing Party already under government inquiry can still make a disclosure.
The new form is SRDP Disclosure Form CMS-10328 (Form), and Disclosing Parties must use the Form beginning on June 1, 2017. The Form must be submitted electronically (no faxes), and be submitted along with a hard copy of a Certification signed by the Disclosing Party that is sent through the mail. The Form requires the following information:
- Description of the disclosing party and designated representative
- Pervasiveness of the noncompliance
- Other compliance issues and activities
- Physician information
- Details of the noncompliant arrangement, interest or designated health services (DHS) provided pursuant to referrals
- Financial analysis
There are separate sections with required information that need to be filled out for each physician. The Form also contains instructions, examples, and other information that Disclosing Parties and their legal counsel can use in preparing a self-disclosure.
Published statistics on the settlement amounts under the SRDP show that as of the end of calendar year 2016, CMS had settled 233 disclosures ranging from $60 to $1,195,763, for a total of $23,209,222. During that same timeframe, 92 disclosures were withdrawn from the SRDP, closed without settlement, or settled by law enforcement.