Monday, July 1, 2024

Congressional Support of Breakthrough Coverage: The Latest Iteration

June 27, 2024 - see a press release from Congr. DelBene that "Breakthrough Legislation" has sailed past a bipartisan House committee, on a 35-6 vote.

Press Release

Legislative Text [23pp]

See coverage at MedPage Today, where I'm quoted:

See coverage at Fierce Healthcare, noting that only $10M is allocated for the new coverage over 5 years:


AI Corner [edited], Chat GPT

Breaking Down the Ensuring Patient Access to 

Critical Breakthrough Products Act of 2023

A Promising Leap Towards Faster Medicare Coverage

After 15 years of policy work on the commercialization of novel medical technologies, I'm enthusiastic about the forward movement for the Ensuring Patient Access to Critical Breakthrough Products Act of 2023. The legislation promises to significantly enhance the Medicare coverage landscape for breakthrough medical devices.

Streamlining Access to Innovation

Currently, the path from FDA approval to Medicare coverage can be unpredictably slow, often taking up to three years. This delay impedes seniors' access to life-saving and life-enhancing medical devices. The proposed legislation addresses this by establishing a four-year transitional coverage period for FDA-designated breakthrough devices, ensuring they are deemed reasonable and necessary for Medicare coverage immediately upon approval or clearance.

Quoting Representative Suzan DelBene, "Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives." This sentiment underscores the urgent need for a more efficient process, one that this bill seeks to implement​. 

Key Provisions of the New Bill

  1. Transitional Coverage:

    • Breakthrough devices will be covered by Medicare for a four-year transitional period starting from the date of FDA approval or clearance.
    • During this period, these devices will receive additional payments under various Medicare payment systems, such as the inpatient and outpatient prospective payment systems.
  2. Unique Coding and Payment Adjustments:

    • The Secretary of Health and Human Services (HHS) is mandated to assign unique codes to each breakthrough device within three months of FDA approval/clearance.
    • Payment systems will be updated semiannually or quarterly to incorporate these codes, ensuring that the costs associated with breakthrough devices are adequately recognized.
  3. Specified Breakthrough Devices:

    • The bill introduces the concept of "specified breakthrough devices," which covers breakthrough devices that do not have a prior benefit category under Medicare. 
      • This provision is particularly innovative as it expands coverage to include devices like digital therapeutics that were not contemplated when Medicare was first established​. 
  4. Permanent Coverage Determination:

    • By the end of the transitional period, CMS must make a permanent coverage determination based on the data collected. This ensures continued access to innovative devices while fostering the generation of real-world evidence.

Impact on Bundled Payments

One of the significant challenges in Medicare reimbursement has been the integration of breakthrough devices into bundled payment systems. The proposed legislation addresses this by making these devices eligible for additional payments during the transitional period, even if they are typically included in broader service payments. This approach recognizes the unique costs associated with breakthrough devices and aims to ensure that they do not fall through the cracks of bundled payment methodologies.

A Win-Win for All Stakeholders

The Ensuring Patient Access to Critical Breakthrough Products Act is a win-win for innovative companies, healthcare providers, and, most importantly, patients. It provides a clear and predictable path for the integration of breakthrough devices into Medicare, encouraging continued investment and innovation in medical technologies. By expediting the coverage process, it ensures that seniors receive timely access to the latest advancements in medical care.

The 'specified breakthrough device' is an unusually named policy by which breakthrough devices can be covered even if they don't have a prior benefit category. This provides an excellent initial period for real-world evidence. Such devices will receive careful tracking and reports to Congress. So far, it looks like a win-win for innovative companies, providers, and patients.

 [ / end Chat GPT ]


See a February 2024 letter from AdvaMed to CMS asking for quick action on TCET.