This bill amends the Social Security Act to allow certain breakthrough medical devices to receive conditional approval for Medicare's New Technology Add-On Payment (NTAP) program, even if they are not yet approved by the FDA by the usual deadline, so that Medicare beneficiaries can access these new technologies sooner.
Sec. 2, Increasing adoption of and access to breakthrough devices: This section adds a new clause to the Medicare law. It says that a breakthrough device that is not yet approved, cleared, or authorized by the FDA by the usual deadline may still be conditionally approved for NTAP for a fiscal year, starting in the first quarter after it gets FDA approval, as long as that approval happens before July 1 of the fiscal year the applicant applied for. A breakthrough device is defined as one that the FDA has designated for expedited development and priority review and that has been approved, cleared, or authorized for that same indication. This clause is not considered an adjustment and must be implemented in a budget-neutral way. The changes take effect upon enactment and apply to breakthrough devices approved on or after July 1, 2023.
Summary of the bill text as introduced in House (Apr 11, 2024), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
Actions
HouseReferred to the Subcommittee on Health.Dec 17, 2024
HouseReferred to the Subcommittee on Health.Apr 12, 2024
HouseIntroduced in HouseApr 11, 2024
HouseReferred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.Apr 11, 2024
House Ways and Means CommitteeReferred To Apr 11, 2024
Subcommittee: Health SubcommitteeReferred to
House Energy and Commerce CommitteeReferred To Apr 11, 2024
Subcommittee: Health SubcommitteeReferred to
Sponsor and cosponsors4 cosponsors
Rep. Mike Carey (R-OH-15)Sponsor, Apr 11, 2024
Danny Davis (D-IL-7)OriginalJoined Apr 11, 2024
Beth Van Duyne (R-TX-24)Joined May 21, 2024
Carol Miller (R-WV-1)Joined May 24, 2024
Mike Kelly (R-PA-16)Joined May 28, 2024
Amendments0
No amendments offered
Cost estimates and reports0
No cost estimate or committee report yet
Titles2
Short titles
Patient Access to Innovative New Technologies Act of 2024Short Title(s) as Introduced
Official titles
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.Official Title as Introduced