Medicare Advantage plans will soon need to provide four years of coverage for eligible devices with FDA breakthrough status, despite ongoing concerns from insurers. The requirement comes under the Medicare Coverage of Innovative Technology rule (MCIT), which has been delayed until May 15 for reevaluation. The deadline is now fast approaching, and MA plans must prepare to comply with the rule, despite ongoing warnings that the devices may hold uncertain benefits for members.
These concerns stem from less rigorous requirements for evidence on safety and effectiveness, a group of physicians wrote in The New England Journal of Medicine.1 The FDA’s Breakthrough Devices program, among other requirements, states eligible devices must provide “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.” However, the devices are approved based on shorter studies2 and are not required to provide postmarket safety studies as a coverage condition, even when such studies are required under the FDA authorization.3
In addition to uncertain benefit, use of the pathway could bring significant expense if the breakthrough program continues to expand.4 The CMS expects to spend more than $2 billion on 14 MCIT-eligible devices in 2024.5 As there are already more than 4002 breakthrough devices, the NEJM piece says that “grossly underestimates the number of devices that would be MCIT-eligible.”
Under the interim final rule, CMS may include commercial health plans’ coverage as it decides whether a device is “reasonable and necessary.” This could mean certain differences between payers are overlooked, including geographical differences, varying state regulations, and different clinical and evidence-based criteria.6
As the fate of the rule and the impact on MA plans is debated, health plans must move forward with their plans for compliance now.
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- Rathi, V., et al. Medicare’s new device-coverage pathway – breakthrough or breakdown? NEJM. March 25, 2021. https://www.nejm.org/doi/full/10.1056/NEJMp2101874
- A faster path to Medicare coverage for devices may get slower. Or vanish altogether. Managed Healthcare Executive. April 2021. https://www.managedhealthcareexecutive.com/view/a-faster-path-to-medicare-coverage-for-devices-may-get-slower-or-vanish-altogether
- Fulton, D. MCIT: Not a better way to pay for breakthrough devices. Regulatory Focus. March 12, 2021. https://www.raps.org/news-and-articles/news-articles/2021/3/a-better-way-to-pay-for-breakthrough-devices
- Reflections on a record year for novel device innovation despite COVID-19 challenges. FDA. Feb. 16, 2021. https://www.fda.gov/news-events/fda-voices/reflections-record-year-novel-device-innovation-despite-covid-19-challenges
- Kelly, S. CMS puts the brakes on breakthrough device coverage rule. MedTech Dive. March 16, 2021. https://www.medtechdive.com/news/cms-puts-the-brakes-on-breakthrough-device-coverage-rule/596759/
- Waddill, K. AHIP protests Medicare coverage of innovative technology rule. HealthPayer Intelligence. April 19, 2021. https://healthpayerintelligence.com/news/ahip-protests-medicare-coverage-of-innovative-technology-rule