HHS seeks input on altering anti-kickback regulations to promote value-based healthcare

The US Department of Health and Human Services is seeking public input on how to address regulations, with a focus on the anti-kickback statute, that “may act as barriers to coordinated care or value-based care,” according to a recent posting.

The HHS said it is working to remove “unnecessary government obstacles to care coordination,” and that it is focusing on identifying regulatory provisions that specifically act as barriers to coordinated care.

The agency said that its Office of Inspector General is seeking “to identify ways in which it might modify or add new safe harbors to the anti-kickback statute and exceptions to the beneficiary inducements civil monetary penalty (CMP) definition of “remuneration” in order to foster arrangements that would promote care coordination and advance the delivery of value-based care, while also protecting against harms caused by fraud and abuse.”

The HHS said that the OIG identified “the broad reach of the anti-kickback statute and beneficiary inducements CMP” as potentially impeding to coordinated care arrangements, and is seeking comments on safe harbors to the statute and the exceptions that may improve care, according to a government posting.

The agency said it is considering suggestions for new safe harbors or modifications to existing safe harbors within the anti-kickback statute that may “promote care coordination and reduce regulatory impediments to value-based arrangements.”

AdvaMed prez & CEO Scott Whitaker touted the move from the HHS, saying that the removal of select barriers could improve 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 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. 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,” Whitaker said in a press release. “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.”

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