-Shu Xiang (Regulatory Affairs Specialist, Mittal Consulting)

House Committee Advances Bill for CMS Coverage of Breakthrough Medical Devices

A bill that would mandate the Centers for Medicare and Medicaid Services (CMS) to provide expedited temporary Medicare coverage of breakthrough medical devices cleared the House review committee, pushing it further along the legislative path.

The Breakthrough Devices Program was launched by the Food and Drug Administration (FDA) in 2015, to expedite the marketing authorization of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. However, Medicare coverage for breakthrough devices after FDA authorization remains a barrier, as the coverage determination for these products can take up to five years.

Intended to bring breakthrough technologies to Medicare patients, the proposed Ensuring Patient Access to Critical Breakthrough Products Act of 2024 (H.R. 1691) mandates four years of transitional Medicare coverage for certain devices with an FDA breakthrough designation. It also requires the CMS to make a permanent coverage determination by the end of the coverage period. If passed, H.R. 1691 will bridge a critical gap between FDA marketing authorization and permanent coverage determination, which may take years. It can significantly de-risk the well-known “valley of death” in MedTech innovation, where new technologies die before market adoption takes off. The bill passed the Ways and Means Committee by 36-5 on June 27, 2024, and is advanced for Chamber debate.

Eligibility Criteria. Devices eligible for coverage under H.R. 1691 must fulfill all the criteria below:

1. The device must have the FDA Breakthrough Device Designation.

2. The device must have marketing authorization via the premarket approval (PMA), De Novo, or 510(k) pathway.

3. If cleared via the 510(k) pathway, the device must be cleared based on a clinical trial that enrolled Part A and Part B Medicare beneficiaries.

4. The device must not be a clinical diagnostic lab test.

Additionally, transitional coverage will be excluded if the device is not provided according to FDA-approved labeling, or if the clinical data presents risks that outweigh the benefits for Medicare beneficiaries.

Transitional Coverage Period. Under H.R. 1691, beginning 18 months after its enactment, the manufacturer of eligible devices can apply for transitional Medicare coverage. The CMS then determines the eligibility within six months of the application and designates it as a breakthrough device for coverage purposes. Transitional coverage begins upon the designation.

H.R. 1691 is not the first attempt to address the Medicare coverage gap for breakthrough devices. In 2020, the CMS introduced the Medicare Coverage of Innovative Technology (MCIT) pathway intended to provide four years of coverage following FDA marketing authorization. The MCIT final rule was rescinded in 2021 due to operational challenges and concerns over the lack of information on device benefit/risk to Medicare beneficiaries. The new bill seeks an alternative solution to bring novel MedTech products to Medicare patients.

If you are interested in obtaining the FDA breakthrough device designation, discuss it with Mittal Consulting today. Our expert team is ready to guide you through the process and achieve regulatory success for your medical device innovation.

References

H.R. 1691, the “Ensuring Patient Access to Critical Breakthrough Products Act of 2023”, https://waysandmeans.house.gov/wp-content/uploads/2024/06/H.R.-1691-Bill-Text.pdf, accessed July 16, 2024.

Amendment in the Nature of a Substitute to H.R. 1691, the “Ensuring Patient Access to Critical Breakthrough Products Act of 2023”, https://waysandmeans.house.gov/wp-content/uploads/2024/06/AINS-to-H.R.-1691.pdf, accessed July 16, 2024.

Tortoise And Hare: Congress May Overtake CMS In Years-Long Race to Set Medicare Breakthrough Device Coverage, https://www.lexology.com/library/detail.aspx?g=8b46d16d-d681-498e-b38d-0434f63ed7a7, accessed July 16, 2024.

Stanford Biodesign Policy Survey Finds Multi-Year Delays in Access to Breakthrough Medical Devices, https://biodesign.stanford.edu/our-impact/stories/new-biodesign-policy-program-research-explores.html, accessed July 16, 2024.