H.R. 4441: Patient Access to Innovative New Technologies Act of 2025

This bill, known as the Patient Access to Innovative New Technologies Act of 2025, aims to enhance access for Medicare beneficiaries to new medical technologies, particularly breakthrough medical devices. Here are the main points of what the bill would do:

Changes to Medicare New Technology Add-On Payment Program

The bill proposes amendments to the Medicare New Technology Add-On Payment (NTAP) Program, which allows Medicare to provide additional payments for new medical technologies that enhance health care quality and outcomes.

Conditional Approval for Breakthrough Devices

Under the proposed changes, certain breakthrough medical devices that have not yet received full approval from the FDA can still qualify for conditional approval under the NTAP Program. This means that:

• A breakthrough device that has not been approved, cleared, or authorized by specific FDA sections by a certain deadline may receive conditional approval for an add-on payment if it obtains the necessary FDA approval before July 1 of the fiscal year being applied for.
• The definition of a breakthrough device includes devices designated for expedited development and priority review by the FDA and those that have received any form of FDA approval for the specific use sought.

Implementation and Budget Neutrality

The bill mandates that the new provisions be implemented in a budget-neutral manner, meaning that the overall financial impact on the Medicare budget should not increase due to these changes.

Effective Date

The amendments will take effect as soon as the bill is enacted. They will apply to any breakthrough device approved or cleared after July 1, 2023.

Relevant Companies

None found