Content Management System (CMS) implementation of breakthrough payment rule may be further delayed

  • August 03, 2021

The medtech industry is broadly supportive of Medicare Coverage of Innovative Technology (MCIT), which will mean breakthrough medical devices automatically get Medicare reimbursement on the day they receive FDA clearance or approval.  AdvaMed CEO Scott Whitaker said the policy is “good government” and “good common sense,” arguing it is logical to facilitate reimbursement of devices that FDA has ruled to be safe and effective.

Yet, other stakeholders argue that different levels of evidence are needed to secure FDA authorization for a breakthrough device and get Medicare reimbursement.  Those critics see MCIT as forcing Medicare to pay for devices that lack safety and effectiveness evidence that demonstrate proven benefits.  “While it’s possible that MCIT could move forward in its current form on May 15, we believe it’s more likely that CMS will again delay implementation to address some of the concerns, which may or may not involve CMS reissuing a proposed rule,” Assaraf wrote.  It remains unclear if CMS will delay MCIT and, if it does, how far back it will push the go-live date.  If CMS delays MCIT by long enough, it could enact a form of the policy as part of the next version of the 21st Century Cures Act or through the 2022 reauthorization of FDA user fees, the analyst said.

Delaying MCIT by that long would give CMS time to assess and act on the feedback it has received on the proposal. CMS reopened the public comment period as part of the original 60-day delay. Last month, CMS uploaded 97 comments about the proposal.  The comments cover the wide range of views about MCIT.  Novartis voiced support for the proposal, arguing that it “will help ensure predictable coverage for advanced diagnostics that are often required by the FDA for on-label use of a drug or biological.”  The National Comprehensive Cancer Network, in contrast, warned that MCIT “poses serious transparency challenges” that need solving.

The Medicare Payment Advisory Commission, a congressional adviser for the Medicare program, opposed the rule in 2020 before it was finalized and again when the rule was paused by the Biden administration.  “The Medicare program, not the FDA, should adjudicate coverage and spending determinations based on the specific needs of the Medicare population,” MedPAC stated in its April public comment.  “The determination of whether a service is covered by the Medicare program should rest with CMS because the FDA’s approval process may not explicitly consider whether a device under question is appropriate for Medicare beneficiaries.”

Cowen also identified America’s Health Insurance Plans and current and former Medicare Evidence Development & Coverage Advisory Committee members Peter Bach and Rita Redberg as “notable detractors.  “Sloan Kettering’s Peter Bach was an early critic of MCIT.

Nonetheless, AdvaMed contends that a growing number of patient groups have voiced their support for the MCIT rule, including the American Diabetes Association (ADA) and National Health Council.  “Under current regulations, individuals with diabetes are often left waiting.  FDA approval does not guarantee patients and providers immediate access to breakthrough devices; and obtaining Medicare coverage for new devices that could benefit Medicare-eligible seniors can take several years,” ADA said in a statement supporting MCIT.

REFERENCE:  MedTechDive; 10 MAY 2021; Nick Paul Taylor

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