Per CMS, Stark Law Modifications Around the Corner

In her Federation of American Hospitals’ 2019 Public Policy Conference speech, CMS Administrator Seema Verma indicated the Stark Law would be receiving a major overhaul sometime in 2019. This update, according to Verma, will “represent the most significant changes to the Stark Law since its [1989] inception.”

One of the primary goals of this update is to ensure the policy maintains relevance in the modern health care world with the relatively recent implementation of electronic health records and cybersecurity. This includes the clarification of certain areas of noncompliance as well as reflection of the shift from a fee-for-service model to a value-based care model.

These regulatory modifications come in response to CMS’ public Request for Information (RFI) in June 2018 concerning adjustments that may be necessary in order to lessen any undue impact or burden brought about by the Stark Law. Specifically, CMS solicited responses regarding “the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the physician self-referral law, and terminology related to alternative payment models and the physician self-referral law.”

More than 300 comments were received in response to the RFI, primarily calling for an overhaul of the policies regarding punishment for providers that inadvertently violate the Stark Law by missing a signature or using an incorrect date. An exception for providers in value-based arrangements was also requested by commenters.

Other changes promised by Verma include the clarification of the regulatory definitions of volume or value, commercial reasonableness, and fair-market value. The update will also address areas of “technical noncompliance”, such as missing signatures and incorrect dates.

“It is our hope that these changes will help spur better care coordination and help support our work to remove barriers to innovation,” Verma said.

The Health Law Partners will continue to monitor and report these updates as they become available.