Coverage of Breakthrough Technologies at Center of New House Committee Hearing

This week, AdvaMed, the Medtech Association, praised ongoing legislative efforts to develop a pathway for Medicare coverage for FDA-approved breakthrough technologies during a House Committee on Energy and Commerce Subcommittee on Health hearing.

“For many Medicare patients, access to FDA-approved breakthrough medical technologies is a matter of life and death, making a predictable pathway for CMS coverage of these devices a top priority for AdvaMed and our industry. Patients simply cannot wait any longer,” said Scott Whitaker, AdvaMed President and CEO. “We appreciate the progress being made on this issue on a number of fronts in Washington, including a bipartisan legislative solution, today’s Energy and Commerce Health Subcommittee hearing, and CMS’s ongoing focus on the TCET rule. There is a lot of work left to do to ensure patients have access to the innovative breakthrough technologies available, and we look forward to work with lawmakers and policy makers to move the program forward.”

The hearing, entitled “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology”, included testimony from AdvaMed Board member Dr. Lishan Aklog, Chairman and CEO of PAVMed and Lucid Diagnostics; and Dr. Todd Brinton, Chief Scientific Officer of AdvaMed member company, Edwards Lifesciences, on the importance of timely access to life-saving medical technologies.

During his testimony, Dr. Aklog said, “[O]ver many decades, medical technology innovation has provided us with novel devices, diagnostic tests and, more recently, digital health tools which have reduced the burden of disease, relieved suffering, and, yes, saved millions of lives.

“Congress and the relevant governmental agencies must play a critical role by keeping up with the pace of innovation and updating our systems to facilitate it. For example, as recently as ten to fifteen years ago, the industry norm was that Europeans patients got access to groundbreaking technologies developed and manufactured right here in America—five or even ten years before our own citizens. That is no longer the case due to improved and more predictable processes at FDA. By providing similarly predictable paths to Medicare coverage of emerging technologies, Congress and CMS have the opportunity to assure equitable access to live-saving innovations for Medicare beneficiaries.”

During his testimony, Dr. Brinton said, “Streamlining the process to make coverage of breakthrough medical technologies more transparent and efficient is one way that we can ensure that medical technology innovation flourishes, rather than languishes.

“The proposed TCET guidance is a foundational step toward greater predictability. That said, more predictability is needed around the concepts CMS describes, including Evidence Preview, Evidence Review, and Evidence Development Plans, as well as the agency timelines.

“[T]ime is of the essence to address the gaps that breakthrough technologies often face between FDA approval and CMS coverage. Further delay may prevent Medicare patients from gaining access to breakthrough medical innovations. For the millions of patients with cardiovascular disease like Jill, and others suffering from diseases with unmet needs, we cannot wait.”

Last month, CMS issued its proposed Transitional Coverage for Emerging Technologies (TCET) rule. In response, Whitaker said, “We’re pleased that CMS has finally issued the TCET notice.  While the draft rule requires further review, we are pleased that CMS recognizes the need to improve the coverage process for seniors. We continue to believe that immediate coverage of FDA approved technologies represents the best path forward to ensure seniors receive the benefits they need and America’s Medtech companies continue to lead the world in medical innovation.  We look forward to reviewing draft rule and working work with CMS and Congress to bring the certainty and transparency to medical innovation that American seniors deserve.”

In March, the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act was introduced in the House of Representatives by Reps. Brad Wenstrup (OH-02) and Suzan DelBene (WA-01). In response to the introduction of the bill, Whitaker said, “Access to innovative, FDA-approved breakthrough technologies is vital for Medicare beneficiaries who are working with their doctors to treat illnesses and live healthy lives. This legislation is an important part of the ongoing reforms that are taking place within CMS to make this a reality for patients.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.