Washington, D.C. – The Digestive Health Physicians Association (DHPA) voiced support for proposed rules issued by the Centers for Medicare and Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (HHS-OIG) to modernize the federal physician self-referral (Stark) law and the federal Anti-Kickback Statute (AKS). The proposals will facilitate innovative arrangements for coordinating care consistent with a shift to a value-based health care system.
DHPA has been at the forefront advocating for modernization of the Stark Law and AKS, including through its work with 28 other provider groups to help develop and support the Medicare Care Coordination Improvement Act of 2019 (S. 966, H.R. 2282), bipartisan legislation that would substantially improve care coordination for patients, improve health outcomes and restrain costs by allowing physicians to participate and succeed in alternative payment models.
“After years of advocating for modernization of the Stark Law and Anti-Kickback Statute, it’s very promising that CMS and the OIG are addressing the restrictions on coordinated care that are fundamentally at odds with the value-based payment system established by Congress in the bipartisan Medicare Access and CHIP Reauthorization Act of 2015,” said Dr. Michael Weinstein, president of DHPA. “Allowing physicians in independent medical practices to participate in Alternative Payment Models and other value-based payment arrangements is critical to enhancing the accessibility, quality, and cost efficiency of care for Medicare patients.”
In response to 2018 Requests for Information, DHPA submitted comments outlining how CMS and HHS-OIG – consistent with their existing regulatory authority – can modernize the Stark Law and AKS to account for the shift from fee-for-service medicine to value-based care delivery.
The proposed rule on Stark Law reform includes many of DHPA’s earlier recommendations, including changes to the definition of fair market value to eliminate the connection to the volume or value standard, which has been an impediment to developing alternative payment models and other value-based care initiatives. The proposed rule, if finalized, would create new exceptions to the Stark Law for value-based arrangements that would apply to care delivery for all patients, not just Medicare beneficiaries.
The proposed rule on AKS reform creates three new safe harbors, including for care coordination arrangements aimed at improving quality and outcomes, value-based arrangements with substantial downside risk, and value-based arrangements with full financial risk. It also proposes modifications to the existing safe harbor under the AKS for personal services and management contracts to add flexibility for outcomes-based payments and part-time arrangements.
“We’re continuing our assessment of the proposed rules, but so far it looks like they will provide important protections for independent physicians participating in value-based payment arrangements. This is very beneficial to our patients, who look to independent GI practices for high quality, cost-efficient and coordinated care,” said Dr. Naresh Gunaratnam, DHPA chair of health policy. “We’re encouraged that CMS and HHS-OIG recognize that the decades-old Stark and AKS regulations need to be updated to ensure that independent physicians can care for their patients without the regulatory burdens of laws that were not designed for a value-based care delivery system.”