AdvaMed Statement on CMS’s Proposed Rule for Breakthrough Technology Coverage

June 23, 2023

WASHINGTON, D.C. –  AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the recently issued proposed Transitional Coverage for Emerging Technologies (TCET) rule:

AdvaMed logo

“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.”

During the rulemaking process,  AdvaMed wrote to CMS , outlining practical considerations the agency could easily incorporate into its proposed rule, reflecting feedback from the medical technology companies that are developing products and methods to diagnose and treat diseases, improve patient quality of life, and save lives.

From the letter :  “We believe that CMS, in order to advance its health equity and other goals, can and must play a critical role in advancing access to emerging innovations that would improve health outcomes for the array of Medicare beneficiaries it serves. We also believe that we share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients.”

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.” 


Improving patient access to breakthrough medical technologies is a top priority this year for AdvaMed, highlighted in the organization’s  Medical Innovation Agenda for the 118 th  Congress  earlier this year.  

Investing in America’s Biopharmaceutical Infrastructure Strengthens the Economy and Supports Union Workers

By Maria Thacker Goethe • December 20, 2025
The biopharmaceutical industry is growing America’s manufacturing and R&D capabilities to develop the next generation of treatments. A recent study from PILMA quantified the impact of the industry’s investment in American infrastructure on the economy and union workforce across 18 states from 2019-2024. The study found that across the 18 states included, the biopharmaceutical industry: Supported the American economy by investing $86.5B in R&D and manufacturing infrastructure and developing 1000+ construction projects at over 700 distinct facilities. Strengthened the American workforce by generating $2.6B in skilled union wages and providing $19M in support for union apprenticeships. The impact of the biopharmaceutical industry’s investment in American manufacturing and union jobs extends beyond direct benefits, spurring additional economic activity in the communities where workers live. This is known as the multiplier effect . On average, every $1 of new investment in a U.S. biopharmaceutical manufacturing facilities generates an additional $1.59 in further economic activity (2.59x times the initial investment value). The industry’s $86.5B investment in R&D and manufacturing infrastructure has a total economic impact of $224B. Check out this resource to learn more about how biopharmaceutical investment in American infrastructure supports America’s workers and communities. For more on how biopharmaceutical companies are investing in America’s future, visit innovation.org/america-investment .

Georgia Life Sciences Joins National Coalition Urging Congressional Action on Key Innovation Policies

December 10, 2025
Georgia Life Sciences has joined 43 state and regional life sciences organizations in signing a national Council of State Bioscience Associations (CSBA) letter calling on Congress to take immediate action on three bipartisan policy priorities that are essential to sustaining U.S. leadership in biomedical innovation and supporting patients nationwide. With Congress back in session and several critical programs at risk of expiring, the letter urges congressional leaders to advance the following provisions without delay: 1. Reauthorize the Rare Pediatric Disease Priority Review Voucher (PPRV) Program The PPRV program has been instrumental in incentivizing the development of therapies for children with rare and life-threatening conditions. Its lapse threatens to slow or halt research that families across the country are counting on. 2. Extend the SBIR/STTR Programs The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide crucial early-stage capital for emerging biotech and medtech companies—many of them in Georgia. Without reauthorization, hundreds of innovative small businesses face uncertainty, jeopardizing new therapies, diagnostics, and technologies in the pipeline, 3. Advance PBM Transparency Reforms Greater transparency and accountability within pharmacy benefit manager (PBM) practices are needed to ensure that savings reach patients and employers. Reforming PBM operations is essential to strengthening access and affordability across the healthcare system. A Unified Message from the Life Sciences Community The sign-on letter reflects broad, bipartisan alignment across the national life sciences ecosystem: researchers, entrepreneurs, investors, patient advocates, and state associations all share a common message— these programs underpin America’s global competitiveness and are vital to patients who rely on continued scientific progress. Georgia Life Sciences has shared the letter with members of Georgia’s congressional delegation and will continue engaging with policymakers to emphasize the importance of swift action.

GLS Joins Georgia Partners in Calling for Federal PBM Reform

December 7, 2025
Georgia Life Sciences is proud to stand with patient advocates, providers, and employers across the state in urging Congress to take meaningful action on pharmacy benefit manager (PBM) reform. We recently signed on to a joint letter to Georgia’s Congressional Delegation stressing the urgent need for transparency, fair practices, and policies that ensure savings flow directly to patients.
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