Among the top issues generating buzz at this week's AdvaMed conference was the decision by CMS earlier this month to propose killing off the Medicare Coverage of Innovative Technology pathway for breakthrough devices due to clinical evidence concerns.
AdvaMed has protested the proposed CMS repeal, remains disappointed but contends there is still hope for a potential compromise. At the same time, the agency's chief medical officer suggested an alternative payment pathway.
"We believe that a number of the concerns the agency has raised could have been mitigated ... without going back to the drawing board," Andy Fish, executive director of AdvaMed's Center for Digital Health and Head of Sector Initiatives, said Monday.
"We have been working with the agency for a number of years on this proposal so we're hopeful that we can move forward on next steps, if that's where the agency decides to go."
Under the previously proposed CMS rule, Medicare would have provided immediate national coverage for four years for any new medical device or diagnostic designated as a breakthrough technology by FDA.
But CMS ultimately decided to repeal the MCIT rule following a previous public comment period in which stakeholder groups raised concerns about the lack of information as to whether such devices would be beneficial or harmful to Medicare beneficiaries.
AdvaMed CEO Scott Whitaker last week challenged the agency's assertions regarding the safety and effectiveness of such devices.
"I don't think there are folks at CMS who have better expertise than folks at FDA about whether a product is safe or effective," Whitaker told reporters. "Their remit is to cover or not cover."
Lee Fleisher, chief medical officer and director of the Center for Clinical Standards and Quality at CMS, defended the agency's decision at the conference.
Fleisher's prepared remarks noted the payment rule would guarantee coverage of any device with FDA breakthrough designation and market authorization, without consideration as to whether it is appropriate and provides benefits for Medicare patients.
Among CMS' concerns about MCIT were that the rule did not require that a breakthrough device demonstrate clinical benefits for people with Medicare, Fleisher told the conference. "It did not discuss evidence," Fleisher emphasized.
MCIT doesn't require the continued development of evidence during coverage for the Medicare population, which is particularly problematic for higher-risk devices, according to Fleisher.
"Seniors and people with disabilities who make up the Medicare population often have complex medical needs and unique health considerations compared to other patient populations. This can change the potential risks and benefits of a new device in the Medicare population," Fleisher added.
The agency's CMO also said CMS is concerned that MCIT might "disincentive" the development of innovative technologies that do not meet FDA's breakthrough designation.
"We believe a more flexible coverage pathway that leverages existing statutory authorities may be better able to provide faster coverage of new technologies to our beneficiaries while prioritizing patient health and outcomes," Fleisher concluded.
If the proposed rule on repealing MCIT is finalized, Fleisher said CMS is committed to issuing an alternative reimbursement pathway "that permits us to evaluate how a device works for the Medicare population" based on the potential collection of additional evidence through clinical trials, outcome registries and real-world data.
Fleisher was not able to take questions on the topic from the audience at the conference given the open public comment period on the proposed CMS repeal of MCIT until Oct. 15.
Whitaker told reporters the lobby will continue to make its case to CMS and Congress.
"If CMS has a better way to do this, we are all ears," Whitaker said. "We welcome the dialogue."
MCIT could also be addressed in the next iteration of the 21st Century Cures Act (Cures 2.0) that includes codification of the breakthrough payment pathway into law.
Edwards Lifesciences CEO Michael Mussallem in a MedTech Conference session commented that "Congress could certainly make things easier." Mussallem contends that "right now it's kind of vague authority that CMS has to use coverage with evidence development and Congress could pass a law to make it more clear."
