It’s hard to find topics of bipartisan agreement these days in Washington, D.C. However, more than 60 House Representatives from both political parties recently signed a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure opposing CMS’ recent repeal of the Medicare Coverage of Innovative Technology (MCIT) final rule that granted expedited Medicare coverage to breakthrough medical devices.
If implemented, the rule would have allowed devices with breakthrough-device designation from the Food and Drug Administration (FDA) up to four years of Medicare coverage after receiving/clearing the agency’s market authorization. When the rule was implemented, CMS noted that its goal was to remove the gap between regulatory authorization and Medicare coverage determination, which can sometimes take up to a year.
On November 12, 2021, however, CMS opted to repeal the final rule because the clinical data necessary for the FDA’s green light may not apply to the Medicare population’s complex conditions or care needs. CMS also stated it plans to investigate other potential coverage process improvements that have “appropriate health and safety protections in place for the Medicare population.”
In the letter, the lawmakers noted that they “do not support” the November CMS decision to repeal the Rule, nor the “multiple postponements” the Agency issued throughout the year as it evaluated the Rule.
“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. “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.”
In addition, the letter encouraged CMS to maintain access to breakthrough products as any rulemaking undergoes a public notice and comment period in an attempt to “accommodate patients who may have benefitted from this coverage had it gone into effect as originally finalized.”
Lawmakers close out the letter by asking CMS to stick close to the now-repealed rule when it creates the replacement, asking “to retain the crucial components of the MCIT rule by providing for immediate or near-immediate temporary coverage of breakthrough devices – both for prospectively and retrospectively approved devices – for a similarly reasonable period of time.”