Georgia Life Sciences, AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech

August 20, 2025 -


The Honorable Dr. Mehmet Oz

Administrator Centers for Medicare & Medicaid Services

7500 Security Blvd. Baltimore, MD 21244

 Adm

inistrator Oz, We, the undersigned organizations, urge the Centers for Medicare & Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access breakthrough medical technology. Closely aligning the efforts of the Food and Drug Administration (FDA) and CMS, the rule will streamline regulatory coordination and eliminate unnecessary obstacles standing between physicians and patients, helping to make Americans healthier.


Every day, Medicare patients across the country confront diagnoses, unexpected health emergencies, and the challenges of managing chronic conditions. Simultaneously, new and innovative medtech are continuously developed, offering profound improvements in patient care, health, and outcomes. Medtech has helped shrink the duration of hospital stays by 38%, reduce deaths from breast cancer by 43%, and decrease fatalities from heart disease and stroke by 49%. Medtech also aids in earlier identification of diseases such as Alzheimer’s and Parkinson’s, underscoring the critical importance of patient access to these advancements.

Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology. A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life.


Existing programs, including the Transitional Coverage of Emerging Technologies (TCET) program, fall short of providing the consistent, timely, and predictable access that breakthrough technologies demand. Its voluntary nature and limited scope – among other issues – fall short of delivering the life-changing innovations to patients who need them most. This administration has a significant opportunity to course correct and make meaningful progress on improving American health.

We have long supported a swift and streamlined approach to Medicare coverage of innovative medical devices and diagnostics that improve health outcomes for patients with debilitating or life-threatening illnesses. We are encouraged by Administrator Oz’s early focus on exploring options for a better pathway for recently approved medical devices, and we encourage CMS to take bold action. A program mirroring the core tenets of the original Medicare Coverage of Innovative Technology (MCIT) framework, embodied in legislative proposals like S. 1717, offers a superior solution.

This would provide coverage for FDA market authorized breakthrough technologies – including diagnostics – ensuring that Medicare patients and their care teams have more timely access to innovations upon FDA clearance. Crucially, it would also provide a clear, predictable roadmap for CMS to collect additional necessary evidence for making a permanent coverage decision. This would – in addition to removing or bridging regulatory obstacles – demonstrate CMS’s commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country.

Sincerely,


Access Ready, Inc

  • AdvaMed
  • All Wheels Up
  • Alliance for Aging Research
  • Alzheimer's Association
  • Alzheimer's Impact Movement
  • American Association for Homecare
  • American Cancer Society Cancer Action Network
  • American Diabetes Association
  • American Music Therapy Association
  • Arizona Bioindustry Association, Inc. (AZBio)
  • Arthritis Foundation Association of Black Cardiologists
  • Autistic Women & Nonbinary Network
  • Bio Nebraska
  • Biocom California
  • BioFlorida
  • BioForward
  • Wisconsin BioUtah
  • Breakthrough T1D
  • Brem Foundation to Defeat Breast Cancer
  • California Life Sciences
  • CDx Diagnostics
  • Colorado BioScience Association
  • Conquering CHD
  • CureLGMD2i Foundation
  • Florida Medical Manufacturers Consortium (FMMC)
  • Georgia Life Sciences
  • HealthCare Institute of New Jersey (HINJ)
  • HealthyWomen Heart Valve Voice US
  • Hydrocephalus Association
  • Illinois Biotechnology Innovation Organization, iBIO
  • Indiana Life Sciences Association
  • International Registry of Rehab Technology Suppliers
  • Life Science Oklahoma
  • Life Science Tennessee
  • Life Science Washington
  • Life Sciences Pennsylvania
  • LifeSciencesNY
  • Maryland Tech Council
  • MassMEDIC
  • Medical Alley
  • Michigan Biosciences Industry Association (MichBio)
  • Missouri Biotechnology Association
  • Montana Bioscience Alliance
  • National Health Council
  • National Psoriasis Foundation
  • NC Life Sciences Organization
  • New Mexico Biotechnology & Biomedical Association
  • NewYorkBIO
  • NH Life Sciences (NHLS)
  • ONE CANCER PLACE
  • Oregon Bioscience Association
  • Patients Rising
  • Rehabilitation Engineering and Assistive Technology Society of North America (RESNA)
  • RI Bio
  • Right Scan
  • Right Time Say YES to Hope
  • South Dakota Biotech
  • Spina Bifida Association
  • Texas Healthcare & Bioscience Institute
  • The Mended Hearts, Inc.
  • The Ohio Life Sciences Association
  • Virginia Biotechnology Association
  • Voices of Alzheimer’s
  • Women's Health Advocates

GLS 2025 Year in Review

December 22, 2025
Dear Georgia Life Sciences Community, As we reflect on the past year, I want to extend my sincere thanks to our Georgia Life Sciences members for making it such an impactful one. Your engagement and leadership continue to move our industry forward and advance our shared strategic priorities— driving strong policy, expanding the talent pipeline, and creating intentional spaces for collaboration across Georgia’s life sciences ecosystem. Our Year in Review captures the progress we’ve made together across these priorities and highlights the collective impact our members are having statewide—from strengthening the workforce and supporting manufacturing growth to elevating Georgia’s position as a national life sciences leader. This progress is only possible because of the collaboration, commitment, and insight of our member community. 

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.
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