AdvaMed to CMS: “Patients Are Still Waiting—But We’re Encouraged Congress No Longer Wants to Wait”

Whitaker Calls on Biden Administration to Move Faster on TCET Rule; U.S. House Holds Hearing on Breakthrough Medtech

WASHINGTON, D.C. – AdvaMed, the Medtech Association, today called on the Biden Administration to implement a proposal to create a predictable pathway to national Medicare coverage for breakthrough medical technologies. The announcement comes as the U.S. Centers for Medicare & Medicaid Services (CMS) failed to meet its self-imposed April deadline to provide a proposed Transitional Coverage for Emerging Technologies (TCET) rule.

“More than two years ago, CMS said it was ‘committed to establishing an expedited Medicare coverage pathway’ to ensure beneficiaries would have ‘expeditious coverage’ of critical devices. But we have yet to see a new rule which is consistent with that goal,” said Scott Whitaker, AdvaMed President and CEO. “We’re waiting. Patients are still waiting. We’re encouraged that Congress no longer wants to wait. We appreciate Reps. Buchanan and Doggett for holding today’s hearing and moving forward on the critical question of how best to ensure that patients have access to the latest, safest, and most effective breakthrough medical technologies to address their suffering.

“We do remain hopeful that CMS will act soon, but any further delay would not feel like a commitment to the Medicare patients who may be waiting for new, breakthrough treatments to help alleviate their suffering. However, we will continue our work with CMS, as well as Members of Congress, to move this important medical breakthrough program forward.”

Today, the U.S. House of Representatives’ Committee on Ways & Means’ Subcommittee on Health, led by subcommittee chair U.S. Rep. Vern Buchanan (R-Fla.) and subcommittee ranking member U.S. Rep. Lloyd Doggett (D-Tex.), held a hearing on whether current federal policy fosters or constrains medical innovation and patient access to the latest technologies and therapies.

At the hearing, Dr. Josh Makower, professor of medicine and bioengineering at the Stanford University Schools of Medicine and Engineering and director and cofounder of Stanford Byers Center for Biodesign, said in his as-prepared remarks:

“Increasingly, medical technology innovators are confronting a ‘valley of death’ where their technologies have received FDA authorization, but often no CMS or insurance coverage is in place to allow patients to gain access to them. Simply put, America’s seniors and patients across the country are all too often not getting timely access to critical medical technologies for many years, if ever.

“A swift, predictable pathway for coverage of breakthrough medical technologies would encourage innovators and investors to take on high-impact projects in fields that are important to Medicare beneficiaries, such as cardiovascular disease, stroke, and cancers. Achieving appropriate reimbursement is one of the greatest risks that innovators, and the investors who fund them, must consider in deciding whether to undertake new projects to improve patient care.

“Based upon our extensive research and findings, we do believe that a well-designed program that enables coverage while continuing to collect evidence could benefit patients by accelerating access to important health advances and encouraging invention, innovation and investment in critically important areas of unmet clinical needs.

“The tragic truth is while this ‘valley of death’ remains, patients throughout the United States – in each of your Congressional districts – are being impacted, unable to access breakthrough medical technologies that have been proven to be safe and effective by the FDA. In addition to CMS’s rulemaking, Congress has introduced legislation to address these serious concerns for the past three sessions with strong, bipartisan support, including in the last session: ‘CURES 2.0.’ At root, the concept that would be ideal is to obtain coverage very shortly after FDA authorization, allowing any continued evidence collection needed to be obtained as the process of adoption begins. As a physician and innovator, and honestly, as a potential Medicare patient someday sooner than I’d like to admit, I encourage all of you to continue the strong bipartisan work towards addressing this growing concern.”

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.”

Last year, AdvaMed sent a letter to CMS Administrator Chiquita Brooks-LaSure and Principal Deputy Administrator Jon Blum, providing practical considerations the Agency could incorporate into a proposed TCET rule that reflected feedback from the medtech companies that are developing the next generation technology.

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