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Jon Dobson
February 23, 2017

AdvaMed Applauds HLC White Paper Outlining Legal Reform Needed to Support Health System Transformation

Washington, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from Chief Operating Officer and General Counsel Christopher L. White following the Healthcare Leadership Council’s release of a white paper, entitled “Health System Transformation: Revisiting the Federal Anti-Kickback Statute and Physician Self-Referral (Stark) Law to Foster Integrated Care Delivery and Payment Models”:

“AdvaMed applauds release of the HLC white paper, which advances the medical technology industry’s advocacy for modernization of U.S. anti-kickback statute and safe harbor regulations to facilitate the health care system’s shift away from traditional fee-for-service models toward value-based models.

“Value-based health care collaborations between medtech manufacturers, health care providers, and others, are key to improving patient outcomes, reducing overall costs, and improving the patient experience.

“The chief concerns of the medtech industry in advancing value-based arrangements include current limitations in anti-kickback statute safe harbors for discounts, warranties and personal services, and the resulting need to provide protection for bona fide value-based arrangements; and the current off-label promotion enforcement framework, which may aggressively construe the sharing of scientific and health care economic information to develop and operationalize value-based arrangements as implied off-label claims.

“Of particular interest to the medtech industry, AdvaMed supports the HLC proposal to create an Anti-Kickback Statue safe harbor and Physician Self-Referral exception for clinically and financially integrated programs that allow all types of stakeholders to participate, give stakeholders flexibility in meeting those requirements to enable the program to achieve its goals, and allow distribution of financial savings to support clinical and payment integration.

“We look forward to continuing to work with HLC to educate policymakers and other stakeholders on the need for legal framework modernization to facilitate medtech value-based collaborations with health care providers, to help achieve health system transformation for the benefit of patients.”