Patient Access to Innovative New Technologies Act of 2025
- Bill Number
- H.R. 4441
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-07-16: Referred 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.
- Last Updated
- 2025-09-16T08:05:33Z
AI-Generated Summary
Purpose of the Legislation
The Patient Access to Innovative New Technologies Act of 2025 aims to enhance Medicare beneficiaries' access to innovative medical devices that improve health care quality and outcomes. It does this by allowing certain advanced devices—known as "breakthrough devices"—to receive faster payment support under Medicare's New Technology Add-On Payment (NTAP) program, reducing delays in their availability to patients.
Key Provisions
- Eligibility for Conditional Approval: Breakthrough devices can receive conditional approval for NTAP payments even if they miss the standard regulatory deadline for FDA approval, clearance, or authorization (as outlined in federal regulations). This approval takes effect for hospital discharges starting in the first quarter after the device receives FDA approval, provided that approval occurs before July 1 of the fiscal year for which NTAP was applied.
- Definition of Breakthrough Device: A breakthrough device is a medical device that:
- Receives a "breakthrough device designation" from the FDA for expedited development and priority review (under section 515B of the Federal Food, Drug, and Cosmetic Act, which speeds up the process for devices addressing life-threatening or irreversibly debilitating conditions).
- Is subsequently approved, cleared, or authorized by the FDA for the specific indication (use) covered by that designation.
- Budget Neutrality: The changes are implemented without increasing overall Medicare spending (budget neutral) and are not treated as an adjustment to payment rates.
- Effective Date: The law applies upon enactment and covers breakthrough devices approved, cleared, or authorized by the FDA on or after July 1, 2023.
Significant Changes to Existing Law
- Amends Section 1886(d)(5)(K) of the Social Security Act, which governs NTAP under Medicare's hospital inpatient payment system.
- Introduces a new exception for breakthrough devices, allowing conditional NTAP eligibility despite missing the typical application deadline (set in federal regulations at 42 CFR 412.87(f)(2)). Previously, devices had to meet strict timing requirements for NTAP consideration, potentially delaying access if FDA review extended beyond deadlines.
Potential Impacts
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will need to adjust NTAP processes to handle conditional approvals, but in a budget-neutral way, meaning no additional federal funding is required. This could streamline administrative reviews for innovative devices without expanding overall program costs.
- On Citizens: Medicare beneficiaries, particularly those with serious health conditions, may gain quicker access to cutting-edge medical devices, potentially leading to better health outcomes and reduced wait times for treatments.
- On International Relations: Minimal direct impact, though it could indirectly encourage global medical device innovation by making the U.S. market more attractive for FDA-designated breakthrough technologies.
Main Stakeholders Affected
- Medicare Beneficiaries: Primary beneficiaries who stand to gain faster access to innovative treatments.
- Medical Device Manufacturers: Companies developing breakthrough devices will benefit from reduced delays in Medicare reimbursement, accelerating market entry and adoption.
- Hospitals and Health Care Providers: Facilities participating in Medicare's inpatient payment system can more readily offer new technologies and receive add-on payments to cover costs.
- FDA and CMS: Regulatory and payment agencies will implement the changes, potentially increasing workload for tracking and approving eligible devices.
Notable Legal, Constitutional, or Political Implications
- Legal Implications: Strengthens the integration between FDA's breakthrough device program (established in 2015) and Medicare payments, promoting consistency in federal health policy. The budget-neutral requirement ensures compliance with existing Medicare payment statutes that limit spending increases.
- Constitutional Implications: None significant; the bill operates within Congress's authority to regulate interstate commerce and federal spending programs like Medicare.
- Political Implications: Supports bipartisan goals of advancing health innovation and patient access, as evidenced by introduction by representatives from both parties. It could influence future debates on balancing innovation incentives with fiscal responsibility in entitlement programs.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (2)
Rep. Davis, Danny K. [D-IL-7], Rep. Vindman, Eugene Simon [D-VA-7]
Recent Actions
- 2025-07-16: Referred 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.
- 2025-07-16: Referred 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.
- 2025-07-16: Introduced in House
- 2025-07-16: Introduced in House
Bill Versions
- Patient Access to Innovative New Technologies Act of 2025 — issued 2025-07-16 — PDF (3 pages)