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

Georgia Life Sciences Launches New Podcast Series, Vitals, in Partnership with Cloudcast Media

October 6, 2025
Atlanta, GA — October 6 — Georgia Life Sciences today announced the launch of Vitals, a new podcast series developed in partnership with Cloudcast Media, a leader in branded podcast production. The series will spotlight the people, ideas, and innovations shaping the future of Georgia’s rapidly growing life sciences sector. Hosted by Georgia Life Sciences’ CEO, Maria Thacker Goethe, Vitals will feature in-depth conversations with scientists, entrepreneurs, investors, educators, policymakers, and patient advocates. Each episode will explore the challenges and opportunities facing Georgia’s life sciences ecosystem—spanning biopharma, medical technology, digital health, and advanced manufacturing. “Vitals gives us a powerful platform to showcase the remarkable work happening within our state,” said Maria Thacker Goethe. “By sharing these stories, we’re highlighting not only groundbreaking science but also the collaboration and talent that make Georgia such a vibrant hub for health innovation.” Cloudcast Media, known for its expertise in storytelling and high-quality podcast production, will bring industry insights and technical support to ensure the series reaches audiences across Georgia and beyond. “We’re proud to partner with Georgia Life Sciences on Vitals,” said Charles Parisi, Founder and CEO of Cloudcast. “This series will elevate the voices of innovators who are advancing science, improving patient outcomes, and building Georgia’s reputation as a global life sciences leader. We are very excited that Cloudcast Atlanta can play a role in supporting Maria and the impactful work of Georgia Life Sciences.” The first episode of Vitals launched today and is available on Apple Podcasts, Spotify, and other major streaming platforms, as well as through the Georgia Life Sciences website.

BIO Statement on Most Favored Nation Policies

October 1, 2025
September 30, 2025 WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) released the following statement on Most Favored Nation policies: "For too many years, Americans have subsidized the research and development necessary to bring newer and better medicines to patients around the world. As we saw with defense spending and NATO, the solution is not to weaken a strategically important American industry, but for other countries to pay their fair share. “Today’s announcement in the Oval Office highlights the problems with a drug delivery system where half of the cost of innovative medicines goes to middlemen and distributors, and where the supply chain distorts prices paid by the American people. We support a new framework that addresses the cost of medicines by simplifying the system - and making medicines directly available to patients. “But importing socialist price controls through most-favored nation policies fundamentally does not address the imbalance in international pricing for innovative medicines. MFN will not lower the out-of-pocket prices that most Americans pay for medicines. Even worse, it will jeopardize the entrepreneurial spirit and deter the capital necessary for a vibrant and essential American biotechnology industry to thrive and may cause most harm to small and midsize biotech companies, which are responsible for discovering more than half of all new treatments. “Without these biotech innovators and a free-market system, we risk slower scientific progress, decreased access to new medicines, compromised national security, fewer American jobs and perhaps most tragically, a diminished hope for those suffering with illness and disease. There are much better ways to address this problem than MFN.” ###

September GBG Report Now Available – Federal Funding Insights for Georgia Life Sciences Members

September 11, 2025
Members are invited to join G2G’s Monthly GBG Reporting Service Webinar on September 18, 2025 . The first portion ( 12:00–12:30 PM ET ) is free and open to all, offering a high-level overview of current federal funding trends. The second half ( 12:30–1:00 PM ET ) is a premium consultation available only to Georgia Life Sciences members, offering direct access to G2G’s expert team—who have helped secure over $550 million in non-dilutive government funding since 2007. Register here: https://www.g2gconsulting.com/event/non-dilutive-funding-g2gs-monthly-gbg-reporting-service-webinar-14-3/2025-09-18/ Key opportunities this month include DARPA’s Expedited Research Innovation System for CBRN threat defense technologies, BARDA’s I-CREATE diagnostic funding and VANGUARD biomanufacturing tools development (each offering up to $200,000), NIAID tuberculosis and influenza research units (up to $1.5–$2.5 million annually), DoD’s $4 million Advanced Medical Monitor development through MTEC, and multiple SBIR opportunities for sensors and field-deployable diagnostics (up to $209,575 for Phase I awards). The September GBG report highlights 13 immunology and infectious disease opportunities, 10 cognitive and brain health programs, and several biotechnology and biomanufacturing initiatives across federal agencies including the Army, ARPA-H, BARDA, and NSF. Georgia Life Sciences members can access the complete 29-page report with detailed deadlines and eligibility requirements [insert link or portal instructions here]. GLS members can access the full 29-page report with deadlines and submission details by logging into your member portal.
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