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

BIO Statement on the Section 232 Pharmaceutical Proclamation

April 4, 2026
April 2, 2026- WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) , released the following statement on Section 232 Pharmaceutical Proclamation. “A thriving American biotechnology ecosystem is essential to growing the U.S. economy, strengthening national security, and improving the health and well‑being of everyday Americans. While we appreciate the Administration’s recognition of the need for tariff exemptions for certain critical biotech products, the reality is that any tariffs on America’s medicines will raise costs, impede domestic manufacturing, and delay the development of new treatments - all while doing nothing to enhance our national security. “U.S. biotech companies have been eager to expand investments here at home, but tariffs, along with an uncertain policy environment and efforts to force “most‑favored nation” schemes, work directly against that goal. The risks are especially acute for small and mid‑size biotech companies, which develop more than half of all FDA‑approved medicines yet often lack the capital to build dedicated manufacturing facilities as they weather an industry defined by high costs, long development timelines, and significant risk. “The fact is: tariffs divert scarce resources away from research and development, weaken American biotech against China’s rising industry, and ultimately, harm health and economic wellbeing of Americans. “We stand ready to work with the Administration on a long‑term strategy that encourages biotechnology investment, reduces the time, cost, and uncertainty of developing new medicines, expands U.S. biomanufacturing capacity, and ensures American innovation is fairly valued overseas. Tariffs and MFN are not the answer." Source - https://www.bio.org/press-release/bio-statement-section-232-pharmaceutical-proclamation

Georgia Life Sciences Announces 2026 Georgia BioGENEius Challenge Winner

April 1, 2026
Atlanta, GA (April 1, 2026) – Georgia Life Sciences (GLS) is proud to announce that Saisurya Lakkimsetti, a junior at Lakeside High School in Columbia County, has been named the winner of the 2026 Georgia BioGENEius Challenge. The Georgia BioGENEius Challenge took place, as part of the statewide Georgia Science and Engineering Fair (GSEF) at the Classic Center in Athens, Georgia. Forty-seven students from across Georgia competed for this year’s title and cash prize. Jaehyeon Lee, an 11th-grade student from Walton High School, was named runner-up in this year’s competition. The Georgia BioGENEius Challenge recognizes outstanding high school students who are conducting innovative biotechnology research with real-world applications. This year’s top projects, presented in the Global Healthcare Challenge track, demonstrated exceptional scientific rigor and forward-thinking potential in addressing critical healthcare challenges. Saisurya’s research focuses on identifying potential inhibitors for Endocan, a protein known to play a role in glioblastoma tumor growth. Using advanced computational modeling techniques—including AlphaFold and molecular docking tools—she screened thousands of small molecules to identify compounds that may block tumor-promoting signaling pathways. Her work identified several promising candidates that could serve as a foundation for future drug development targeting glioblastoma. Jaehyeon’s project investigates how varying glucose concentrations affect regeneration in planaria, modeling impaired wound healing in diabetic conditions. By testing graded glucose environments and measuring regeneration indicators such as growth and differentiation, Jaehyeon demonstrated that lower glucose levels enhance regeneration while higher levels inhibit healing. The study establishes a model to better understand hyperglycemia’s impact on diabetic wound healing. “The work by these students is a powerful example of the innovation and determination we see in Georgia’s next generation of life sciences leaders,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences. “The BioGENEius Challenge is critical because it provides students with a platform to apply cutting-edge science to real-world problems, while also strengthening the future workforce that will drive breakthroughs in healthcare, biotechnology, and beyond.” The Georgia BioGENEius Challenge is part of Georgia Life Sciences’ broader commitment to advancing workforce development and fostering innovation across the state’s rapidly growing life sciences ecosystem. Judging the 2026 Georgia BioGENEius Challenge: Ian Biggs; Ralph Cordell, CDC; Alex Harvey, ViaMune; Jamie Graham, Smith Gambrell Russell; and Evan Scullin, LuminiSci.

Georgia Life Science's Feature in Very First Atlanta Edition of Inside Medicine

March 24, 2026
Georgia Life Sciences is thrilled to be featured in the very first Atlanta edition of Inside Medicine . This inaugural issue represents something truly special. Atlanta’s healthcare and life sciences community is driven by innovation, collaboration, and outstanding leadership—and we’re honored to be part of this exciting launch. Also in the issue, GLS's Kennedy Dumas is featured, sharing her journey on how observation and research evolved into a powerful practice of journaling. As the founder of Stationery Black, she creates notebooks designed to showcase, uplift, and inspire people of color. Read the full article here.
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