AdvaMed is paying close attention to an initiative by HHS that could impact pricing arrangements for medical devices by adding safe harbors to the federal anti-kickback statute.
HHS last week issued a Request for Information on barriers to coordinated care as part of a broader effort to shift away from fee-for-service and toward value-based care.
The RFI would provide information needed to modernize the anti-kickback statute.
The HHS Office of Inspector General is looking at ways to modify or add safe harbors to the anti-kickback statute to foster arrangements that would promote care coordination while also protecting against fraud and abuse.
The medtech industry has been working with HHS to “remove these archaic roadblocks through AKS modernization,” noted AdvaMed President Scott Whittaker.
Currently, the anti-kickback statute provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward the referral of business reimbursable under federal healthcare programs.
The concern is that because the statute was written so broadly, some innocuous and potentially beneficial arrangements could be subject to criminal prosecution.
The agency is accepting comments from industry on the safe harbors to the anti-kickback statute. Civil monetary penalties could be imposed under the act on anyone who offers remuneration to a Medicare or state healthcare program provider that could influence the provider or supplier.
Remuneration could include waivers of co-payments and deductible amounts and transfers of items or services. However, in a system that is quickly moving toward a more value-based and coordinated care model, stakeholders are pushing HHS to modify existing safe harbors to reduce regulatory impediments to the value-based arrangements.
“Congress intended the safe harbors to be evolving rules that would be updated periodically to reflect changing business practices and technologies in the healthcare industry,” the RFI says.
The RFI notes that healthcare providers and others “may voluntarily comply with safe harbors in an effort to ensure that their business practices will not be subject to criminal prosecution under the anti-kickback statute, the imposition of civil monetary penalties (CMPs),” program expulsion and liability under the False Claims Act.
“When we think about coordinated care, we think about a healthcare 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,” AdvaMed said in its comments.
Device manufacturers can be key players in coordinated care by leveraging their clinical and economic expertise, supply chain management capability and data analytics proficiency, the association said, adding that “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.”
New Safe Harbors
AdvaMed said devicemakers want 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.”
AdvaMed has been working with the OIG and other stakeholders to advance proposals for two new AKS safe harbors — one to protect value-based pricing arrangements and another to protect value-based warranties.
“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,” AdvaMed said.
Read the HHS Request for Information here: www.fdanews.com/08-29-18-Antikickback.pdf.