Dozens of House representatives have taken issue with the Centers for Medicare & Medicaid Services’ (CMS') recent repeal of a Trump-era rule granting expedited Medicare coverage to breakthrough medical devices.
In a letter penned to CMS Administrator Chiquita Brooks-LaSure last week, 61 bipartisan lawmakers wrote that they “do not support” CMS’ Nov. 12 repeal decision nor “the multiple postponements” the agency issued throughout the year as it evaluated the Medicare Coverage of Innovative Technology (MCIT) final rule.
President Donald Trump’s CMS had finalized the rule Jan. 14, just a few months after its proposal and less than a week before President Joe Biden was sworn in to office.
If implemented, the rule would have provided devices that received the Food and Drug Administration’s breakthrough-device designation up to four years of Medicare coverage once the product received or cleared the agency’s market authorization. CMS said at the time that its goal was to remove the gap between regulatory authorization and Medicare coverage determination, which in some cases could take up to a year.
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Similar benefits were highlighted in the letter headlined by Reps. Brett Guthrie, R-Kentucky, Anna Eshoo, D-California, Devin Nunes, R-California, and Suzan DelBene, D-Washington.
“If the rule were to be implemented, instead of spending months or years navigating the health care bureaucracy to receive coverage after FDA approval, medical innovators could prioritize their time and resources to collect data to demonstrate their product's impact on patients and educate providers how to best serve their patients with these innovative products,” the lawmakers wrote in the letter dated Nov. 23. “The MCIT rule could further encourage early investors to step in to address our most critical healthcare challenges and successfully deliver life-changing treatments to patients.”
CMS said it decided to repeal the rule because the clinical data necessary for the FDA’s green light may not specifically apply to the Medicare demographic’s complex conditions or care needs.
The agency also said it is planning to explore other potential coverage process improvements that include "appropriate health and safety protections in place for the Medicare population."
Lawmakers petitioned CMS not to stray too far from the original rule with its replacement, urging the agency “to retain the crucial components of the MCIT rule by providing for immediate or near-immediate temporary coverage of breakthrough devices … for a similarly reasonable period of time.”
Going forward, the representatives also recommended that CMS maintain access to breakthrough products as any rulemaking undergoes a public notice and comment period “to accommodate patients who may have benefitted from this coverage had it gone into effect as originally finalized.”
CMS’ proposal and eventual repeal of the rule came as a disappointment to medical device industry groups that viewed the pathway as an incentive for greater innovation and patient access.
On the other hand, the agency’s caution echoed those of the insurance sector, which warned that the faster timetable proposed by the Trump administration could lead to premature coverage of unproven devices.