You are here

October 9, 2019

AdvaMed Praises New Safe Harbors For Value-Based Care

WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on the Department of Health and Human Services’ issuance of a proposed rule adding new safe harbors and modernizing existing safe harbors in the federal Anti-Kickback Statute (AKS), and on the Centers for Medicare and Medicaid Services’ (CMS’s) issuance of a proposed rule modernizing the Stark Law, to support value-based health care:

“The administration’s proposed updates to the AKS safe harbor and Stark Law regulations are crucial steps toward a more patient-centered, value-based health care system that will help achieve better clinical outcomes, lower costs, and an improved patient experience. We thank White House Domestic Policy Council Director Grogan, Secretary Azar, Deputy Secretary Hargan, Administrator Verma and their staff for their hard work on behalf of America’s patients.

“Today’s medical technology companies don’t just produce devices and diagnostics that save and improve lives, they provide solutions that comprise a range of products and services to improve patient outcomes. They are true partners working to diagnose, treat and manage disease, as well as share accountability for achieving better outcomes and managing costs. HHS’s proposed AKS changes in particular will help make that happen.

“We look forward to reviewing the proposed rules in more detail, and working closely with HHS and CMS on both implementation and finding additional ways to strengthen value-based care across the health care system."

HHS’s proposed rule would establish new and modernized safe harbors under the AKS reflecting AdvaMed priorities. These include three new safe harbors for value-based arrangements – related to exchanges of remuneration and arrangements with financial risk – and proposed modifications to existing safe harbors, including for warranties. CMS’s proposed rule would also add value-based exceptions to the Stark Law to give health care providers added flexibility to improve the quality of care for patients.

For additional background on AdvaMed AKS policy proposals submitted to the HHS Office of Inspector General, please click here and here.