Faster Access to Medical Tech? New House Bill Aims to Speed Medicare Coverage

The healthcare landscape is constantly evolving, with innovative medical technologies emerging at an unprecedented rate. However, a significant bottleneck exists in ensuring that these advancements reach the Medicare beneficiaries who need them most. It can take anywhere from 15 months to 6 years for new technologies to be added to Medicare, creating a frustrating lag between FDA approval and patient access. A new House bill seeks to address this critical issue, potentially revolutionizing how quickly seniors and disabled individuals can benefit from cutting-edge medical breakthroughs.

The Current State of Medicare Coverage for New Medical Technologies

Currently, the process for securing Medicare coverage for new medical technologies is complex and time-consuming. Even after the Food and Drug Administration (FDA) approves a new device, it doesn’t automatically become available to Medicare beneficiaries. This delay stems from several factors, including:

Lengthy review processes: Medicare’s coverage, coding, and payment processes are often slow and cumbersome.
Inadequate payment levels: Initial payment levels for new technologies may be insufficient to cover the cost of the device, discouraging providers from using them.
Regional variations: Coverage decisions are often delegated to Medicare Administrative Contractors (MACs), leading to inconsistencies and delays across different regions.

This sluggish process has significant consequences. Patients are denied timely access to potentially life-saving or life-improving technologies, and manufacturers face challenges in recouping their investments, which can stifle future innovation. As of 2019, securing regulatory approval for a new medical device and gaining Medicare coverage cost an average of $94 million and took 4.5 years. In contrast, the same process can be completed in about 11 months in Europe.

The Ensuring Patient Access to Critical Breakthrough Products Act

To address these challenges, a bipartisan group of representatives has introduced the “Ensuring Patient Access to Critical Breakthrough Products Act.” This bill aims to create a streamlined pathway for FDA-designated breakthrough devices to receive transitional Medicare coverage while the Centers for Medicare & Medicaid Services (CMS) conducts a review for permanent coverage determination.

Key provisions of the bill include:

Four years of transitional coverage: The bill would provide four years of temporary Medicare coverage for breakthrough devices upon the manufacturer’s application.
Expedited review process: CMS would be required to make a permanent coverage determination by the end of the temporary coverage period.
Voluntary application process: Manufacturers can choose to participate in the expedited coverage pathway.
Consideration of medical necessity: The bill includes a section about reviewing the medical necessity and reasonableness of a breakthrough device to address “aberrant billing.”

The bill has garnered support from both sides of the aisle, with sponsors emphasizing its potential to encourage medical device innovation and provide quicker access to treatments for Medicare patients.

Potential Benefits of the New House Bill

If enacted, the “Ensuring Patient Access to Critical Breakthrough Products Act” could have several positive impacts:

Faster access to innovative technologies: Medicare beneficiaries would be able to access breakthrough medical devices much sooner, potentially improving their health outcomes and quality of life.
Increased innovation: The expedited coverage pathway could incentivize manufacturers to develop new and innovative medical technologies, knowing that they will have a clearer path to market.
Reduced administrative burden: The streamlined process could reduce the administrative burden for both manufacturers and CMS, freeing up resources for other priorities.

Concerns and Considerations

While the bill has received widespread support, some concerns have been raised:

Risk of fraud: Some committee members have expressed concerns about the potential for fraud and abuse.
Evidence requirements: Questions have been raised about the type of evidence required to demonstrate the safety and efficacy of breakthrough devices.
Weakening of CMS authority: Some worry that the bill could weaken CMS’s authority to make coverage decisions.
Exclusion of diagnostics: The Advance Medical Technology Association (AdvaMed) has called for the inclusion of diagnostic tests in the bill.

It’s important to note that CMS rescinded the Medicare Coverage of Innovative Technology (MCIT) program in 2021 due to safety concerns, highlighting the need for careful consideration of patient safety when expediting access to new technologies.

The Role of Artificial Intelligence (AI)

The increasing use of artificial intelligence (AI) in medical devices adds another layer of complexity to the coverage landscape. AI-powered devices have the potential to revolutionize healthcare, offering improved diagnoses, personalized treatments, and more efficient care delivery. However, the lack of a clear Medicare payment system for these devices has created uncertainty and hindered their adoption.

To address this, some lawmakers are pushing for legislation that would create a Medicare reimbursement pathway for certain FDA-approved AI/machine learning-enabled medical devices. This could encourage providers to use AI technology in clinical settings and help improve diagnoses for Medicare beneficiaries.

Navigating the Evolving Landscape

As the healthcare industry continues to evolve, it’s crucial to stay informed about the latest developments in medical technology and Medicare coverage policies. Understanding the potential benefits and risks of new technologies, as well as the legislative and regulatory changes that affect access to care, is essential for making informed decisions about your health.

If you or a loved one has been injured due to delayed access to medical technology or other healthcare-related issues, it’s important to seek legal guidance from experienced personal injury attorneys. They can help you understand your rights and explore your options for seeking compensation.

Do you believe this bill will have a positive impact on healthcare?