HR-5343-119
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.
Sponsored by Blake Moore (R-UT)
What it does
This bill would amend the Medicare program to automatically cover FDA-designated "breakthrough" medical devices for a 4-year transitional period beginning when the device receives that designation. The Secretary of Health and Human Services would evaluate manufacturer applications and designate qualifying devices within 6 months. Coverage could be denied only if a device is used outside its FDA-approved labeling or if the Secretary finds, based on clinical data, that the device presents an undue risk of harm outweighing its benefits for Medicare patients. The bill also requires CMS to complete a formal national coverage determination before the transitional period ends, and appropriates $10 million per year from FY2025 through FY2030 to fund implementation.
Who benefits
Medicare beneficiaries (Parts A and B) who need access to newly approved breakthrough medical devices and would otherwise face coverage delays. Medical device manufacturers whose products receive FDA breakthrough designation, as they would gain a guaranteed 4-year Medicare payment window. Hospitals and other providers who furnish these devices and would receive reimbursement during the transitional period. Patients with serious or life-threatening conditions for whom breakthrough devices are often developed. Smaller device companies that may lack the resources to navigate lengthy Medicare coverage processes independently.
Who is hurt
Medicare trust funds and federal taxpayers, who would bear the cost of covering devices that have not yet completed Medicare's standard evidence review. Private insurers, who may face pressure to match Medicare's coverage of breakthrough devices. Competing device manufacturers whose products go through standard coverage pathways and face a longer road to reimbursement. Patients who might receive devices later found to have risks not fully identified during the transitional period. CMS administrative staff, who would face new workload requirements and tight statutory deadlines for designation decisions and coverage determinations.
Supporters argue
Supporters argue that Medicare's current coverage process can take years after FDA approval, leaving seniors without access to devices that have already cleared a rigorous federal safety and effectiveness review. They contend that the FDA's breakthrough device designation — which already requires clinical data including Medicare-aged patients — provides a sufficient evidentiary basis for transitional coverage, and that the bill's 4-year window gives CMS adequate time to complete a full national coverage determination without denying patients access in the interim. Bipartisan co-sponsorship and a 37-3 committee vote suggest broad agreement that the current coverage gap is a concrete, documented problem.
Opponents argue
Opponents argue that FDA approval and Medicare coverage serve distinct purposes — FDA determines safety and effectiveness for general use, while Medicare's coverage process evaluates whether a device is reasonable and necessary specifically for the elderly and disabled Medicare population, who often have different risk profiles. They contend that automatic transitional coverage bypasses this patient-specific review, potentially exposing Medicare beneficiaries to devices whose risks for older patients were not fully established, while also committing federal spending before cost-effectiveness is assessed. Critics may further argue that the $10 million annual appropriation understates the true administrative and coverage costs the program would absorb.
Constitutional context
Congress has broad authority to structure Medicare under the Taxing and Spending Clause (Art. I, §8, cl. 1), and the bill's $10 million annual appropriation is a straightforward exercise of that power. Post-Loper Bright (2024), the Secretary's discretionary determinations — such as finding "undue risk of harm" or designating breakthrough devices — would receive no automatic judicial deference and could face independent court review if challenged by manufacturers or patient groups.
Checks and balances
The Executive Branch (HHS/CMS) gains new authority to designate breakthrough devices and grant or deny transitional coverage; Congress checks this through annual reporting requirements, the 6-month decision deadline, and the requirement that a national coverage determination be completed before the transitional period expires.
Historical precedent
The Medicare Coverage of Innovative Technology (MCIT) rule (2021) attempted a similar automatic 4-year coverage pathway for FDA breakthrough devices but was rescinded by the Biden administration before taking effect, citing insufficient evidence standards — making this bill a legislative attempt to accomplish what that regulation could not.