S. 1717: Ensuring Patient Access to Critical Breakthrough Products Act of 2025

This bill, known as the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, aims to amend Medicare coverage regulations concerning breakthrough devices. Here’s a summary of its key provisions:

1. Prompt Coverage of Breakthrough Devices

The bill seeks to ensure that breakthrough devices, which are new medical devices recognized for their innovative merits by the Secretary of Health and Human Services, receive timely coverage under the Medicare program. It introduces a transitional coverage period of four years during which certain devices can be covered while more extensive evaluations and studies are conducted.

2. Definition of Breakthrough Device

• The term “breakthrough device” refers to any device designated by the Secretary that meets specific criteria for expedited review under the Federal Food, Drug, and Cosmetic Act.
• A “transitional coverage period” is established, lasting four years from the device’s designation date.

3. Determination Process for Designation

From 18 months after the bill's enactment, manufacturers can apply to have their newly developed devices classified as breakthrough devices. The Secretary must make a decision about each application within six months, informing the manufacturer whether or not the device meets the necessary criteria for designation.

4. Reporting and Oversight

The Secretary is required to submit annual reports to Congress, detailing:

• The number of applications received for breakthrough device designation.
• The number of devices that received such designation.
• The number of applications that did not meet criteria for designation.

5. National Coverage Determination

The bill mandates that decisions regarding national coverage for breakthrough devices must be finalized before the end of the transitional coverage period, provided that a request for coverage is submitted timely.

6. Funding Provisions

To facilitate these changes, the bill appropriates $10 million annually from fiscal years 2026 to 2031 to the Centers for Medicare & Medicaid Services. These funds are designated to support the implementation of the amendments introduced by this bill.

Relevant Companies

• MDT - Medtronic: A leading manufacturer of medical devices that could benefit from faster Medicare coverage for its breakthrough products.
• ISRG - Intuitive Surgical: Known for its robotic surgical systems, the company may see expedited coverage and reimbursement for new innovations.
• ABT - Abbott Laboratories: Produces various breakthrough medical devices and could experience increased market access due to the bill.