H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act

Bill Summary

H.R. 5343 would require Medicare to automatically cover devices approved under the Breakthrough Devices Program of the Food and Drug Administration (FDA). That program is directed at simplifying the approval process for devices used in the treatment of especially severe diseases and conditions. Under the bill, Medicare would be required to cover those devices for a four-year transitional period immediately following FDA approval.

Estimated Federal Cost

The estimated budgetary effect of H.R. 5343 is shown in Table 1. The costs of the legislation fall within budget function 570 (Medicare).

Basis of Estimate

For this estimate, CBO assumes that H.R. 5343 will be enacted early in fiscal year 2026.

The Medicare program does not automatically cover the use of every medical device approved by the FDA. Medicare conducts its own evaluations—reviews that can delay or prevent payments to hospitals that use the devices in treating beneficiaries. CBO expects that enacting H.R. 5343 would lead Medicare to cover more FDA-approved breakthrough devices and that the program’s payments to hospitals would increase as a result. In particular, spending would rise for new technology add-on payments (NTAPs), which supplement Medicare’s payments to hospitals for treatments that have been identified as novel, effective, and costly.

CBO estimates that under current law, over the 2028-2035 period, NTAPs will amount to $1.4 billion for roughly 130 breakthrough devices, at a cost of about $11 million per device. (Because devices typically can qualify for NTAPs for multiple years, the annual payment per device will be less than $11 million.)

Direct Spending

CBO estimates that enacting H.R. 5343 would increase direct spending by $906 million over the 2026-2035 period.

Based on analyses of the rate and timing of NTAPs for breakthrough devices, CBO expects that enacting H.R. 5343 would increase by roughly 25 percent the number of devices that would be covered by Medicare and eligible for NTAPs. As a result, over the 2026-2035 period, fee-for-service spending would increase by about $370 million for Medicare and by $476 million for Medicare Advantage plans. H.R. 5343 also would appropriate $10 million each year between 2026 and 2031 to cover the administrative costs of implementing the bill. Based on historical spending patterns for similar activities, CBO estimates that providing those amounts would increase outlays by $60 million over the 2026-2035 period.

Uncertainty

CBO’s estimate for H.R. 5343 is subject to considerable uncertainty. The FDA’s pace of device approvals has accelerated in the recent past. According to data from the agency, more than twice as many devices were approved between 2023 and 2025 than were approved between 2020 and 2022.[1] Although this estimate is based on the number of currently approved breakthrough devices, it is difficult to predict how many the FDA will approve over the next few years or what Medicare would spend on their coverage.

Pay-As-You-Go Considerations

The Statutory Pay-As-You-Go Act of 2010 establishes budget-reporting and enforcement procedures for legislation affecting direct spending or revenues. The net changes in outlays that are subject to those pay-as-you-go procedures are shown in Table 1.

Increase in Long-Term Net Direct Spending and Deficits

CBO estimates that enacting H.R. 5343 would increase net direct spending by more than $2.5 billion in any of the four consecutive 10-year periods beginning in 2036.

CBO estimates that enacting H.R. 5343 would increase on‑budget deficits by more than $5 billion in any of the four consecutive 10-year periods beginning in 2036.

Mandates

The bill contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act.

Estimate Prepared By

Federal Costs: 
Katie Kim 
Sarah Sajewski

Mandates: Andrew Laughlin

Estimate Reviewed By

Asha Saavoss
Chief, Health Systems and Medicare Cost Estimates Unit

Kathleen FitzGerald
Chief, Public and Private Mandates Unit

Chad Chirico 
Director of Budget Analysis

Estimate Approved By