HHS Considering Expanding Antikickback Statute Safe Harbors to Promote APMs

The federal government is considering making changes to healthcare fraud and abuse laws in order to better enable care coordination and value-based payments, and it is seeking feedback through a Request for Information (RFI) on the antikickback statute of the Stark Law.

The RFI follows another one with a comment period that ended on August 24 for which CMS sought comments on the Stark Law in general and how its regulations may hinder value-based arrangements.

According to the request from the HHS Office of the Inspector General (OIG), the department is looking to remove unnecessary obstacles to care coordination that can accelerate the transformation to a value-based system.

“…OIG has identified the broad reach of the anti-kickback statute and beneficiary inducements CMP [civil monetary penalty] as a potential impediment to beneficial arrangements that would advance coordinated care,” according to the RFI.

HHS wants stakeholders to comment with ways it could modify existing safe harbors or create new ones under the antikickback statute. The statute prohibits the exchange of anything of value in order to induce the referral of federal healthcare program business. The safe harbor regulation was added in 1987 to allow HHS to protect certain arrangements and practices.

Learn about the RFI on the Stark Law.

The American Academy of Family Physicians (AAFP) wrote on its site that it is strongly urging CMS to reconsider the Stark Law. In a letter to CMS, AAFP wrote that advanced primary care models should have safe harbors covering operation and financial arrangements and physician practice flexibility.

“As the move to value-based care continues, the AAFP expects existing and future APMs [alternative payment models] under [the Medicare Access and CHIP Reauthorization Act] to accelerate the need to coordinate and integrate care across payment and delivery settings—and will likely give rise to substantial need for waivers for physicians from the Stark Law,” AAFP wrote.

According to the RFI, some topics of interest include:

1. The structure of arrangements between parties that participate in APMs or other new payment models designed to promote care coordination and value.
2. The need for new or revised safe harbors and exceptions to the definition of “remuneration under the beneficiary inducements CMP to promote care coordination, patient engagement, and value-based arrangements.
3. Terminology related to APMs, value-based arrangements, and care coordination.

Responses to the antikickback statute RFI are due October 26.