Reversing the Reversal

Earlier this month, CMS announced its intention to eliminate the Medicare Coverage of Innovative Technology program, which was seen by many medical device startups as the major benefit of the FDA’s Breakthrough Device program. The decision sent shockwaves through the device industry, which has been on edge since the Biden administration announced it would reconsider the program, which was implemented via executive order in the waning days of the Trump administration.

Although the MCIT rule was widely lauded by the medical device industry, it had its critics, including the health insurance industry. And a highly critical article in the New England Journal of Medicine also had a negative impact. In announcing the reversal, CMS claimed that the rule lacked requirements for vendors to supply evidence of benefits to the Medicare population.

AdvaMed president Scott Whitaker was quick to denounce the impending MCIT repeal. “Repealing MCIT is the wrong decision for countless Medicare patients, and it’s the wrong decision for American medical innovation,” he said. “Our goal in this country should be to spur and not inhibit innovation that will change patients’ lives. We will continue to make this important case with the Administration and Congress, and we are hopeful they will make the right decision.”

While the likely repeal of the MCIT rule is certainly a blow to the medtech industry—including several neurotech startups who have already obtain breakthrough device designation—there is hope for salvaging at least some of its provisions. CMS left the door open for drafting a modified rule. “There are other ways to achieve our stated goals. This may include better utilizing existing pathways or conducting future rulemaking,” the agency said. We believe that a revised MCIT rule that required breakthrough vendors to conduct post-market studies and data collection specifically from Medicare patients would stand a much better chance of approval.

There is also the possibility of a legislative override. Rep Diana DeGette of Colorado, a key figure in passing the Cures Act, has included support for MCIT in a new public health bill dubbed “Cures 2.0.” This bill would likely enjoy bipartisan support in Congress, as did the original Cures Act.

And even if neither of those two options materialize, there is still the possibility of a non-governmental MCIT-like program supported by private insurers, investors, and industry. We proposed such a plan in this space a while back [NBR Jan19 p2].

It’s in the industry’s interest to pursue all three of these avenues in order to restore the full promise that the FDA’s Breakthrough Device program offered to startups.

James Cavuoto
Editor and Publisher