H.R. 5343: Ensuring Patient Access to Critical Breakthrough Products Act

This bill, titled the Ensuring Patient Access to Critical Breakthrough Products Act, aims to modify the Medicare program to enhance the coverage of breakthrough devices. Here’s a summary of its main provisions:

1. Definition of Breakthrough Devices

The bill establishes a formal definition for breakthrough device, which refers to devices designated by the Secretary of Health and Human Services that meet specific criteria. These devices are typically those that have received priority review by the FDA and are intended for patients who would benefit from new technology for treatment or diagnosis.

2. Transitional Coverage Period

The bill introduces a transitional coverage period of four years for breakthrough devices upon their designation by the Secretary. During this period, Medicare will provide coverage for these devices under certain conditions.

3. Ensured Coverage During Transitional Period

To ensure that breakthrough devices receive prompt coverage, the bill amends the Social Security Act to allow coverage unless the device has been determined to:

• Not meet FDA-approved labeling requirements.
• Present an undue risk of harm outweighing clinical benefits.

4. Designation Process for Breakthrough Devices

Manufacturers can request designation for their devices. The Secretary has up to six months to determine whether the device meets specified criteria, which include:

• Having priority review as outlined in existing FDA regulations.
• Clinical data supporting its effectiveness for Medicare beneficiaries.
• Being eligible for coverage under Medicare.
• Not presenting undue risks compared to potential benefits.

5. Reports and Reviews

The Secretary of Health and Human Services is required to submit annual reports to Congress detailing the number of applications for breakthrough designations and the outcomes of those applications.

6. National Coverage Determinations

The bill mandates that decisions regarding national coverage for breakthrough devices be made within the transitional coverage period if requests are submitted in a timely manner.

7. Funding Provisions

The legislation includes provisions for funding, allocating $10 million annually from 2025 to 2030 for the Centers for Medicare & Medicaid Services (CMS) to implement the provisions of this act.

8. Review of Billing Patterns

The Secretary is empowered to review the medical necessity and billing patterns of health care providers with regards to the provision of breakthrough devices to ensure that services provided are reasonable and necessary.

Relevant Companies

• MDGL - The company manufactures and may develop breakthrough medical devices aligned with the act's criteria, thus potentially increasing their market reach and Medicare reimbursement opportunities.
• DHR - As a global leader in medical technology, any breakthrough devices they launch could be expedited through Medicare under this bill, potentially boosting sales.