Press Releases

AdvaMed Commends HHS RFI To Modernize AKS To Advance Value-Based Health Care


Jon Dobson
[email protected]
(202) 434-7272

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after issuance of a Request for Information (RFI) from the U.S. Department of Health and Human Services (HHS) calling for modernization of the federal Anti-Kickback Statute to advance beneficial value-based health care:

“AdvaMed commends efforts by HHS to address barriers to coordinated care as part of the broader shift away from fee-for-service and toward value-based health care. HHS’s RFI will further document and provide information needed to modernize the federal Anti-Kickback Statute (AKS) to realize the benefits of coordinated care.

“When we think about coordinated care, we think about a health care system in which all participants are invested in good patient outcomes. But there remain significant regulatory roadblocks that stand in the way of the medtech industry’s full participation. That’s why the medtech industry has been working with HHS and other policymakers to remove these archaic roadblocks through AKS modernization.

“Medtech companies not only create life-changing innovations that save and improve thousands of patients’ lives every day, they can also be key players in coordinated care by leveraging their clinical and economic expertise, supply chain management capability and data analytics proficiency. These capabilities can facilitate clinical guarantees – and intelligent bundling of services, information technology and life-changing medical technology – to help achieve better outcomes, lower costs and an improved patient experience.

“Simply put, medtech companies want to be full partners in care delivery, to help drive comprehensive solutions to detect, treat, and manage disease, and share accountability for achieving better outcomes as well as managing costs. But the existing AKS and its narrow and outdated regulatory safe harbors deter medtech companies from participating in these value-based arrangements.

“Therefore, AdvaMed has been working with the HHS Office of the Inspector General and other stakeholders to advance proposals for two new AKS safe harbors – one to protect value-based pricing arrangements and the second to protect value-based warranties. See our related comments here.

“These proposals are intended to allow for clinical performance incentive payments and results-based contracts – between providers, between providers and manufacturers, and between manufacturers and payers – that focus on optimizing patients’ clinical outcomes and fostering efficient and cost-effective delivery of care through shared accountability. And, they will facilitate medtech company competition based on outcomes, all for the benefit of patients.

“HHS’s issuance of the related RFI comes on the heels of AdvaMed’s participation June 7 in an agency roundtable on barriers to coordinated care, held as part of HHS’s efforts to examine its regulatory reform agenda.”

For additional information on related industry advocacy, please see AdvaMed’s website here. To access a copy of the RFI, please click here.