AAFP Pushes CMS to Clear 'Safe Harbors' in Stark Law

Self-referral Regulations Should Not Hinder Value-based Models, Academy Advises

September 05, 2018 11:04 am News Staff

The AAFP tells the government clearly and consistently that unnecessary administrative burdens too often stand in the way of the complex, coordinated care family physicians deliver best.

[physician with laptop looking stressed out]

Now one part of this burden may be headed toward reform, and the Academy is giving CMS advice on how to go about that work.

In June, CMS issued a request for information (RFI)(www.gpo.gov) regarding the physician self-referral statute known as the Stark Law. Specifically, the agency wanted input on "how to address any undue regulatory impact and burden" of the law.

Discussion of the Stark Law, which was enacted in 1989, has intensified since the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015. A white paper(www.finance.senate.gov) titled "Why Stark, Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models" the Senate Finance Committee issued pursuant to a roundtable discussion that year neatly summarizes what family physicians have understood for a generation: "The strict liability regime, huge penalties, and the breadth, complexity and ambiguities of the Stark Law and its regulations have created what is often referred to as a minefield for the health care industry."

In early 2016, the Academy recommended(4 page PDF) that Congress "closely monitor and evaluate the potential impact of the Stark Law on innovations in health care delivery and payment."

One such innovation, the AAFP's Advanced Primary Care Alternative Payment Model (APC-APM),(38 page PDF) is cause for CMS to reconsider the Stark Law, the Academy wrote in an Aug. 22 letter(3 page PDF) to CMS Administrator Seema Verma, M.P.H.

"The complexity of the Stark laws and their implementing regulations cause family medicine practices to seek expensive legal advice on their billing arrangements out of concern regarding self-referral laws," reads the letter, which was signed by Board Chair John Meigs, M.D., of Centreville, Ala.

"The AAFP strongly urges CMS to create a simple decision tree for medical practices to help determine if further costly legal opinions may be needed," the letter states. Further, the agency should make sure advanced primary care models have "safe harbors" that cover operational and financial arrangements, as well as physician practice and flexibility.

"As the move to value-based care continues, the AAFP expects existing and future APMs under MACRA to accelerate the need to coordinate and integrate care across payment and delivery settings," the letter says, pointing out that this is likely to lead to many requests from physicians for Stark Law waivers.

"The AAFP urges CMS to ensure that the Stark Law does not hinder family physicians' ability to transform their practices and collaborate with other physicians and health care professionals to provide team-based, patient-centered care that incorporates new technologies and focuses on reducing the total cost of care," the letter states.

Five days after the AAFP wrote to CMS, HHS issued an RFI on anti-kickback provisions of the Social Security Act(www.gpo.gov) that asked for suggestions on establishing safe harbors to anti-kickback rules that would "promote care coordination and advance the delivery of value-based care, while also protecting against harms caused by fraud and abuse." Responses are due Oct. 26.

Both efforts are part of the HHS Regulatory Sprint to Coordinated Care, which is taking a close look at regulations that act as barriers to coordinated care.

Related AAFP News Coverage
CMS Considers New Direct Provider Contracting Model
AAFP Urges Support for Direct Primary Care, Academy's Advanced Primary Care Alternative Payment Model

(6/11/2018)

More From AAFP
Anti-kickback & Stark Compliance

FPM: The Stark Truth About the Stark Law: Part I
(November-December 2003)

FPM: The Stark Truth About the Stark Law: Part II
(February 2004)