Disclosure Protocol

Section 6409 of the Patient Protection and Affordable Care Act  (PPACA) mandated that the Centers for Medicare and Medicaid Services (CMS) develop and implement a voluntary disclosure protocol that health care providers could use to disclose noncompliance with the Stark Law.  On September 23, 2010, in response to this mandate, CMS published the Stark Law Self-Referral Disclosure Protocol (SRDP) on its website.  See www.cms.gov/Medicare/Fraud-and-Abuse/Physician Self Referral: Self Referral Disclosure Protocol.html. 

PPACA also required CMS to submit a report to Congress addressing the implementation of the SRDP.  This report, issued by CMS in late March 2012, indicates many providers are taking advantage of the SDRP as a viable path to resolve outstanding liabilities and to mitigate potential penalties under the Stark Law, however, it also highlights that resolution under the SRDP can be a slow process. 

Disclosure Statistics

The report to Congress contains statistics about the use of the SRDP in the 18 months since its inception. Here are the highlights:

How Many Disclosures? There have been 150 disclosures from 148 providers.

Who is Disclosing? Of those 150 disclosures, CMS has received disclosures from 125 hospitals, 11 clinical laboratories, eight physician groups, two community mental health centers, two durable medical equipment suppliers, one ambulance service company and one health care foundation.

What is Being Disclosed? The most common disclosed violations include failure to comply with the Stark Law exceptions for personal service arrangements, nonmonetary compensation, rental of office space, and physician recruitment arrangements.

What is the Status of the Disclosures? As of the date of the report, 51 disclosures are under active CMS review and an additional 61 disclosures are pending ongoing review while CMS awaits additional requested information from the disclosing party, 20 disclosures are on administrative hold (because of bankruptcy proceedings or law enforcement activities), nine disclosures have been withdrawn, and three disclosures were referred to law enforcement (presumably government agencies, such as the Office of Inspector General or Department of Justice).

How Many Settlements? CMS has settled seven cases (one additional case was settled after submission of the report) with settlements ranging from $60 to $579,000. A summary of the settlements is posted on CMS' website. See https://www.cms.gov/ Medicare/Fraud-and-Abuse/Physician Self Referral/Self Referral Disclosure Protocol Settlements.html.

What is the Basis for Settlement Amounts and What are the Types of Violations? Unfortunately, the report gives no insight into how CMS' determines settlement calculations, and provides no information regarding the number of disclosures involving expired or unsigned agreements.

What Providers Should Know

CMS' report to Congress provides limited insight into how CMS is addressing noncompliance with the Stark Law. With only seven settlements out of 150 disclosures, it is still too soon to tell how useful the SDRP will be to providers who encounter potential issues with the Stark Law. As such, providers should continue to view the SDRP as one of several potential options that are available to address and resolve Stark Law compliance issues.

For More Information

To directly access CMS' SRDP report to Congress: https://www.cms.gov/Medicare/Fraud-and-Abuse/Physician Self Referral/downloads//CMS-SRDP-Report-to-Congress.pdf.