To amend title XVIII of the Social Security Act to improve Medicare beneficiary access to new medical technologies that improve health care quality and outcomes by ensuring that breakthrough devices are eligible for conditional approval under the Medicare New Technology Add-On Payment (NTAP) Program, enabling these medical breakthroughs to be provided to Medicare beneficiaries without unnecessary delay.
Sponsors
Mike Carey
R-OH | Primary Sponsor
Legislative Progress
IntroducedMr. Carey (for himself and Mr. Davis of Illinois) introduced …
Summary
What This Bill Does
This bill modifies Medicare hospital reimbursement rules to help breakthrough medical devices reach patients faster. Currently, hospitals can receive extra "add-on" payments (called NTAP - New Technology Add-On Payment) when they use innovative medical devices. However, devices must be FDA-approved by a certain deadline to qualify for these payments in a given fiscal year.
The bill creates a new pathway: if a device has FDA "breakthrough" designation (meaning the FDA has flagged it for expedited development and priority review because it offers significant advantages), it can receive conditional approval for NTAP even if FDA clearance comes after the normal deadline - as long as final FDA approval happens before July 1 of that fiscal year.
Who Benefits and How
Medical Device Manufacturers: Companies developing breakthrough devices benefit significantly. They can apply for NTAP even before FDA approval is finalized, reducing the gap between FDA clearance and Medicare reimbursement. This makes investment in innovative devices more attractive.
Medicare Beneficiaries (Patients): Patients gain faster access to innovative medical technologies. Without this bill, even after FDA approval, there can be a multi-year delay before Medicare adequately reimburses hospitals for using new devices.
Hospitals: Healthcare facilities benefit from clearer reimbursement pathways for innovative devices, reducing financial uncertainty when adopting breakthrough technologies.
Who Bears the Burden and How
Medicare/Taxpayers: The bill requires budget-neutral implementation, meaning overall Medicare spending should not increase. However, funds may shift from other areas to cover NTAP payments for breakthrough devices.
Established Medical Device Companies: Companies with older, established products may face increased competition as breakthrough devices gain faster market access.
Key Provisions
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Conditional NTAP Approval: Breakthrough devices can receive conditional NTAP approval for a fiscal year, effective for hospital discharges starting the quarter after FDA approval, as long as FDA clearance comes before July 1.
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Breakthrough Device Definition: A "breakthrough device" must (a) have FDA designation under Section 515B of the FD&C Act for expedited development/priority review, AND (b) be FDA-approved/cleared for the indication that earned the breakthrough designation.
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Budget Neutrality: The bill explicitly requires budget-neutral implementation - it "shall not be considered an adjustment" and must be implemented without increasing Medicare costs.
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Retroactive Application: The bill applies to breakthrough devices approved on or after July 1, 2023, providing some retroactive relief for devices that missed previous NTAP windows.
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
To amend Medicare reimbursement rules so that FDA-designated "breakthrough devices" (innovative medical devices with expedited review status) can receive conditional approval for New Technology Add-On Payment (NTAP) even when FDA approval/clearance is granted after the standard NTAP deadline, as long as it occurs before July 1 of the fiscal year.
Policy Domains
Section 2 - Medicare NTAP Amendment
Likely Beneficiaries
- Medical Device Manufacturers (especially those with breakthrough-designated devices)
- Medicare Beneficiaries (faster access to innovative treatments)
- Hospitals (clearer reimbursement for innovative devices)
Inferred from context, no direct clause evidence
Likely Burden Bearers
- Medicare Trust Fund (through reallocation, not additional spending)
- Competing Medical Device Companies with older products
Inferred from context, no direct clause evidence
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "cms"
- → Centers for Medicare & Medicaid Services
- "the_secretary"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
An additional Medicare payment to hospitals for using new medical technologies that meet certain criteria. Part of Medicare's Inpatient Prospective Payment System (IPPS).
A medical device that (1) is designated for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act, AND (2) has been approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the FD&C Act for the indication for which the breakthrough designation was made.
Approval for NTAP that becomes effective for hospital discharges starting the first quarter after the device receives FDA approval, clearance, or authorization, provided this occurs before July 1 of the applicable fiscal year.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology