A bipartisan group of lawmakers on Tuesday called on Medicare and Medicaid center administrator Chiquita Brooks-LaSure to “urgently” propose a policy to replace the Trump-era Medicare coverage policy for disruptive devices that the agency canceled this month.
Meanwhile, lawmakers said the CMS should provide “immediate or near-immediate” temporary coverage for disruptive devices.
“We are writing to express our disappointment in your decision to end the Medicare Coverage for Innovative Technology (MCIT) rule, which would provide access to innovative and life-saving medical devices for Medicare members,” says a letter written by Brett Guthrie (R-Kentucky ), Anna Eshu (California), Devin Nunez (California) and Susan DelBene (Washington State) and have signed over 60 representatives.
Legislators argued that the rule would not only make it easier for older people to access new FDA-approved devices, but it would also make it easier for small medical device manufacturers to navigate the patchwork associated with local coverage definitions and the time-consuming process. Medicare decision making. administrative contractors to get coverage for their devices.
“The irrevocable abolition of the MCIT rule could delay the emergence of innovative medical devices and diagnostic tools in the future,” the letter said. “The MCIT Rule can further encourage early stage investors to step in to address our most pressing healthcare challenges and successfully deliver life-changing treatments to patients.”
The now-canceled Medicare rule, which was finally negotiated in the final days of the Trump administration, would allow Medicare to cover devices designated by the FDA as “disruptive technologies” for up to four years. The FDA’s Advanced Device Program, created as part of the 21st Century Treatment Act, prioritizes the development of innovative devices to treat certain life-threatening or debilitating diseases.
Medicare beneficiaries can currently get coverage for these devices through other methods, such as determining national coverage, but the MCIT rule would create a fast track.
The Biden administration’s CMS on November 12 issued a final rule to repeal the MCIT rule – after multiple delays in rule implementation – citing concerns that the policy would lead to coverage of devices without sufficient evidence. The CMS in its November 12 rule noted that Medicare beneficiaries are not required to participate in clinical trials until they receive FDA approval to market.
The CMS said at the time that it planned to continue to consider ways to improve access to disruptive technologies, perhaps through existing avenues or future rulemaking.
“[W]We want to assure stakeholders that the CMS does not intend to maintain the status quo, – wrote the CMS in its rule of November 12. device coverage by ensuring that Medicare covers items and services based on evidence-based clinical evidence and appropriate guarantees. “