HR 1691 Passes Committee, July 2024, Breakthrough Device Coverage

HR 1691 passess committee.

Budget cut, per trade journals.

https://www.fiercehealthcare.com/regulatory/four-year-coverage-breakthrough-medical-devices-passes-ways-and-means-heavy-discount

https://www.congress.gov/118/bills/hr1691/BILLS-118hr1691ih.pdf

### PRESS:

The House Ways and Means Committee advanced bipartisan legislation on Thursday that would grant Medicare coverage to novel medical technologies for four years while the Centers for Medicare & Medicaid Services (CMS) makes a national coverage determination. 

The new version of the bill that was voted on by Ways and Means reduces the cost of the bill by 75% of the version that the House Energy and Commerce Committee voted favorably on back in November. It allocates $10 million per year over five years to CMS for the project. 

CHAT GPT 4 READS BILL:

The Ensuring Patient Access to Critical Breakthrough Products Act of 2024, if passed, would give any device designated as “breakthrough” from the Food and Drug Administration (FDA) four years of Medicare coverage. Co-sponsor of the bill Rep. Susan DelBene, R-Washington, said during the hearing that it takes CMS an average of more than five years to make a national coverage determination for FDA breakthrough devices.

The proposed Medicare coverage for breakthrough devices under HR 1691, known as the “Ensuring Patient Access to Critical Breakthrough Products Act of 2023,” aims to ensure that innovative medical devices receive prompt coverage. Here are the key aspects and implications of the bill, with a particular focus on the budget allowance:

1. Definition of Breakthrough Devices:

   • The bill defines "breakthrough devices" as those given priority review by the FDA and approved or cleared for use after March 15, 2021.

2. Transitional Coverage Period:

   • Breakthrough devices will be provided with transitional coverage for four years from the date of FDA approval or clearance.
   • During this period, these devices will be deemed reasonable and necessary for Medicare coverage purposes and will be eligible for additional and pass-through payments under various Medicare payment systems.

3. Payment Systems and Additional Payments:

   • The bill specifies that the Secretary of Health and Human Services will assign unique codes for these devices within three months of FDA approval, ensuring they are recognized in relevant Medicare payment systems.
   • These systems include inpatient hospital services, outpatient hospital services, ambulatory surgical center services, physicians' services, durable medical equipment, diagnostic laboratory tests, and others.
   • There will be additional payments or adjustments made to cover the costs of these breakthrough devices during the transitional period.

4. Regular Coverage Process:

   • After the transitional period, the Secretary must establish a process for regular coverage of these devices, considering any additional evidence or data required.
   • This process should avoid duplicating FDA data requests, minimize administrative burdens, and not be unnecessary or redundant.

5. Special Rules for Certain Breakthrough Devices:

   • The bill also addresses "specified breakthrough devices" for which no Medicare benefit category exists, ensuring they receive coverage and payment similar to other breakthrough devices.

6. Budget Allocation:

   • Although the bill does not specify a precise budget allocation for the coverage of these devices, it implies that Medicare will ensure the necessary funds are allocated to cover the costs associated with the transitional and regular coverage periods.
   • There is no direct mention of a $10 million budget cap within the provided sections of the bill. The bill outlines mechanisms for covering the costs but does not limit the total budget.

In summary, HR 1691 seeks to streamline the coverage and payment process for breakthrough medical devices under Medicare, ensuring prompt access and appropriate reimbursement to foster innovation and improve patient care. The focus is on facilitating a smooth transition from FDA approval to Medicare coverage, with specific provisions to support the financial aspects through additional payments and adjustments across different Medicare payment systems.