The medical technology field is rapidly evolving, with new innovations emerging to address critical health challenges. However, the process of getting FDA-approved medical devices covered by Medicare is often slow, leaving many beneficiaries without timely access to potentially life-saving treatments.
While a new Medicare policy has been introduced to expedite coverage for certain breakthrough medical technologies, it does not fully meet the needs of the 65 million Medicare beneficiaries who rely on these advancements. The FDA's "breakthrough" program aims to speed up the review and approval of medical devices that offer more effective treatment options for life-threatening or debilitating conditions. However, the coverage process under Medicare is often sluggish, with many innovative technologies taking years to become available to patients.
The Centers for Medicare & Medicaid Services (CMS) has introduced the Transitional Coverage for Emerging Technologies (TCET) pathway to address this issue, but it has limitations. The current policy only allows for coverage of five devices per year and excludes diagnostic technologies, which does not adequately address the urgent needs of patients.
Legislative developments are underway to address these shortcomings. The House Ways and Means Committee has advanced H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023, which aims to provide a four-year transitional coverage period for designated medical devices. While this bipartisan initiative is a step in the right direction, it currently excludes diagnostics, although there is a plan to include them in future discussions. The Energy and Commerce Health Subcommittee has also passed the bill, indicating a growing recognition of the need for reform.
It is crucial for Congress to pass this bipartisan legislation in a timely manner, as it will not only improve patient access but also stimulate innovation in the medtech sector.
Delayed coverage for breakthrough medical devices has implications for health equity, as many of the conditions addressed by these innovations disproportionately affect underserved populations who rely on Medicare for their healthcare needs. Streamlining the coverage process and expanding access to breakthrough technologies can help address systemic health disparities and improve patient outcomes.
Studies show that patients typically wait over 5.5 years after FDA approval to receive coverage for valuable therapies, which can have dire consequences for those with limited resources. By reforming the bureaucratic processes that hinder access to breakthrough devices, Congress has the opportunity to remove barriers and ensure that seniors, particularly from underserved communities, can access the treatments they need. This is not just a matter of convenience but a critical step toward promoting health equity among older Americans.
The United States has been a leader in medical technology innovation, but to maintain this position and ensure that patients benefit from advancements, it is necessary to reform the current processes. The recent developments in Congress are a pivotal moment for the medtech industry and the millions of patients who could benefit from timely access to innovative treatments. It is crucial for breakthrough medtech coverage to be included in any must-pass end-of-year legislation to advance patient care and foster continued innovation in the sector.