Protect Access to Breakthrough Medical Technologies for Seniors
The U.S. response to the COVID-19 pandemic has reinforced the important role of our domestic life sciences industry in combatting public health threats. Too often, however, the development and Food and Drug Administration (FDA) approval of new medical devices and tests does not guarantee access to these technologies for many vulnerable communities. In the coming days, the Biden administration has an opportunity to build on bipartisan progress, incentivize continued investment in life sciences innovation, and take an important step to ensure America’s seniors have equitable access to breakthrough medical devices by implementing the Medicare Coverage for Innovative Technologies (MCIT) program.
Congress passed the 21st Century Cures Act in 2016 with broad bipartisan support. Among its provisions, 21st Century Cures created a new program at the FDA to expedite development of innovative medical devices and tests that represented ‘breakthrough’ technologies. Breakthrough technologies are so named because they are the first treatment available for a specific condition or offer a significant improvement over existing therapies on the market. Thus, when the FDA issues a breakthrough designation for a device or diagnostic test, it is because they believe that the patient impact will be substantial.
However, when Congress created the FDA pathway for these breakthrough technologies, it did not create a corresponding process for expedited coverage under Medicare. The result is that many medical devices and diagnostics receiving approval under FDA’s Breakthrough Devices Program can wait up to three years before receiving coverage decisions from the Centers for Medicare and Medicaid Services (CMS), which delays access to care for our nation’s seniors.
The value of a ‘breakthrough’ designation is tied directly to getting such products thoroughly reviewed and to patients as quickly as possible. As such, the disconnect between FDA approval and CMS coverage can force American seniors covered by Medicare to wait for years before benefitting from these life-saving innovations. In addition, the coverage gap for breakthrough medical devices can threaten the very existence of small, innovative companies that make up the bulk of the medical technology sector.
The MCIT rule reflects CMS’ commitment to seniors by ensuring that Medicare beneficiaries have timely and appropriate access to innovative medical technologies. The rule provides for automatic, temporary Medicare coverage for FDA-approved, breakthrough-designated devices, and then requires companies and CMS to work together to identify and develop any additional evidence necessary to make a permanent coverage decision. It is now up to the Biden Administration to implement the rule, ensuring beneficiary coverage and access to groundbreaking medical treatment while also sending a clear signal to our innovation ecosystem that risky and expensive investments in breakthrough medical technologies will be rewarded if FDA approves them.
Streamlined, science-based regulatory processes that support getting life-saving devices and diagnostics to patients in need have never been more important as the U.S. continues to respond to the COVID-19 pandemic. We urge the Biden Administration to implement the MCIT rule on time, without delay.
Mike Guerra is President and CEO of the California Life Sciences Association (CLSA), the largest advocacy organization representing California biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers.