Press ReleasesBLOG POST: CMS proposes dropping accelerated Medicare coverage of breakthrough devices

CMS has proposed withdrawing a rule that would have required Medicare to cover breakthrough medical devices for four years immediately after FDA authorization.¹ The rule would require Medicare Advantage plans to reimburse for technology approved under the breakthrough pathway and aimed at reducing the time between FDA approval of a device and Medicare coverage determination.¹

Implementation of the Medicare Coverage of Innovative Technology rule, introduced in the waning days of the Trump administration earlier this year, was previously delayed from March until December by the Biden administration.^1,2 CMS cited concerns about limited evidence on the benefits and risks of breakthrough devices in older populations in its decision to seek repeal.³ The agency added that the rule would make it harder for Medicare to “make case-by-case determinations” on if a device is “reasonable and necessary” for beneficiaries.³

Health insurers balked at the MCIT rule when it was introduced.¹ America’s Health Insurance Plans submitted comments to CMS in April, saying the rule would require “premature coverage of unproven devices for the Medicare population, exposing seniors and people with disabilities to increased health risks.”⁴

CMS is also seeking to repeal a provision in the MCIT that would expand the definition of “reasonable and necessary” for Medicare Part A and Part B because it would allow consideration of commercial insurance coverage, which would create administrative challenges and potentially affect the agency’s “ability to ensure equitable health care access for all Medicare beneficiaries.”^3,5

Public comments on the proposal can be submitted until Oct. 15 of this year.³

To stay up to date on the latest from RAM Technologies, follow us on LinkedIn

^References

1. King, Robert. CMS wants to pull Trump-era pathway that speeds up Medicare coverage of breakthrough medical devices. Fierce Healthcare. Sept. 13, 2021. Accessed Sept. 19, 2021. https://www.fiercehealthcare.com/payer/cms-wants-to-pull-trump-era-pathway-speeds-up-medicare-coverage-breakthrough-medical-devices
2. Taylor, Nick Paul. CMS moves to scrap MCIT rule due to clinical evidence concerns. MedTech Dive. Sept. 14, 2021. Accessed Sept. 19, 2021. https://www.medtechdive.com/news/cms-may-scrap-mcit-rule-advamed-industry-pushes-back/606503/
3. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary.” Federal Register. Sept. 15, 2021. Accessed Sept. 19, 2021. https://www.federalregister.gov/documents/2021/09/15/2021-20016/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and
4. America’s Health Insurance Plans. RE: [CMS-3372-IFC]: Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period. April 16, 2021. Accessed Sept. 19, 2021. https://www.ahip.org/wp-content/uploads/MCIT-IRC-Comments-4.16.21-2.pdf
5. LaPointe, Jacqueline. CMS to Repeal Medicare Coverage of Breakthrough Devices Rule. RevCycleIntelligence. Sept. 14, 2021. Accessed Sept. 19, 2021. https://revcycleintelligence.com/news/cms-to-repeal-medicare-coverage-of-breakthrough-devices-rule