Medical Groups Urge CMS to Accelerate Medicare Access to Innovative Technologies

Key Takeaways

Health organizations urge CMS to streamline access to medical devices for Medicare patients.
Delays between FDA approval and Medicare coverage can exceed six years, limiting patient access to innovations.
Proposed frameworks aim to ensure timely access while maintaining safety and effectiveness standards.

Medical Groups Advocate for Streamlined Coverage of Devices

A coalition of health care and medical technology organizations is calling on federal officials to expedite the process for Medicare patients to access groundbreaking medical devices and diagnostics. In a letter addressed to Dr. Mehmet Oz, the administrator of the Centers for Medicare & Medicaid Services (CMS), the groups requested closer alignment between CMS and the Food and Drug Administration (FDA) to mitigate delays associated with the coverage of innovative technologies. They argue that regulatory barriers hinder seniors from obtaining treatments that could significantly enhance or save their lives.

The letter highlights a concerning statistic: it can take nearly six years from the time a new technology receives FDA authorization to when it gains Medicare coverage. The organizations emphasized the transformative impact of medical technology over recent decades, noting notable advancements that have led to shorter hospital stays and significant reductions in mortality rates for conditions such as breast cancer, heart disease, and stroke. Furthermore, advancements in diagnostics have improved early detection of diseases like Alzheimer’s and Parkinson’s.

While CMS offers initiatives like the Transitional Coverage of Emerging Technologies program, the groups contend these measures do not provide the consistent and timely access necessary for emerging innovations. They recommend adopting a framework similar to the Medicare Coverage of Innovative Technology program, which was introduced but subsequently repealed under a previous administration. This policy would allow for automatic coverage of FDA-approved breakthrough technologies, with a defined timeline for CMS to collect additional evidence required for permanent coverage decisions.

Legislative efforts, such as the Ensuring Patient Access to Critical Breakthrough Products Act, have also sought to formalize this approach. Although the letter commended Dr. Oz for exploring strategies to enhance the coverage pathway, it urged the agency to “take bold action” to ensure that Medicare beneficiaries are not disadvantaged as new treatments come to market. The organizations believe that the current administration has a crucial opportunity to make significant advancements in American health care.

The full letter and a list of signatories can be accessed through the provided link.

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