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

May 22, 2026
ALPHARETTA, Ga., May 21, 2026 (GLOBE NEWSWIRE) -- Micron Biomedical today announced the grand opening of its world-class manufacturing facility spanning more than 26,000 square feet in Alpharetta, Georgia. The opening marks the most advanced commercial-scale manufacturing site for Micron’s dissolvable vaccine and therapeutic technology in the world and positions the company for pivotal clinical trials that will accelerate the availability of needle-free vaccines and therapeutics that can be self-administered at home. “A significant body of evidence has shown that our dissolvable microarray technology is as effective as — or more effective than — conventionally injected medicines. Parents, patients, government officials, drug developers, public health leaders, and payers also prefer needle-free vaccines and therapeutics that are simpler and more cost-effective to transport and store,” said Steven Damon, CEO of Micron Biomedical . “Our novel technology requires equally innovative manufacturing equipment capable of scaling production, and this facility brings us one step closer to making that vision a reality.” Micron’s technology uses a dissolvable microarray “button” that is applied directly to the skin and, when pressed, painlessly delivers medications that dissolve in the uppermost layers of skin. The facility houses all of the equipment and manufacturing capabilities to design and produce Micron’s technology at scale including R&D facilities, wet labs, dry labs, storage and professional office spaces. Micron Biomedical’s grand opening ceremony was attended by business leaders, elected officials, investors, members of academia and other stakeholders. Representatives from the CDC were also in attendance as recently the CDC launched its first-ever clinical trial of a needle-free vaccine, evaluating a novel rotavirus vaccine, CC24, delivered via Micron Biomedical’s dissolvable microarray technology. The trial, at Emory University, builds on research, published in The Lancet, about self-administered seasonal influenza vaccine via Micron Biomedical’s dissolvable microarray technology, as well as studies across other disease indications, including measles and rubella . “Georgia is emerging as one of the country’s most important biotech manufacturing hubs, attracting talented scientists, engineers, business leaders and creating exciting economic and professional opportunities for our residents,” said Todd Jones, Georgia House Representative . “With its award winning first-in-the industry technology, Micron Biomedical is among the state’s leaders in simultaneously transforming the health of people around the world with never-before-possible access to medicine and vaccines - and in investing in the workforce of tomorrow with high paying jobs and growth opportunities." This year, published research reinforced consumer preference for microarray technology and Micron Biomedical was recognized as the number two most innovative company in its class by Fast Company for addressing global demand for simplified administration and distribution of vaccines and drugs. The scientific community support includes recent commentary in The Lancet which called Micron’s technology “game-changing in humanitarian settings.” Micron’s technology class has also been identified as the highest global priority innovation for overcoming immunization barriers in low- and middle-income countries by the Vaccine Innovation Prioritisation Strategy (VIPS) Alliance. “This milestone reflects the type of coordinated ecosystem growth outlined in Georgia Life Sciences’ recently released Roadmap for Georgia’s Life Sciences Sector — bringing together industry, startups, manufacturers, educators, investors, and policymakers to strengthen the state’s innovation and manufacturing capabilities,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences , who attended the ribbon cutting ceremony. “With this cutting-edge facility, Micron is helping advance Georgia’s position as a national leader in biotechnology, medical technology, and life sciences innovation while reinforcing the state’s role as a scale-up manufacturing hub for the Southeast.” “Ribbon cuttings are always special and momentous events, but this one is especially satisfying because it points to an infrastructure for pivotal clinical trials of technologies being studied at Emory that have the potential to save lives and reduce disease burden by expanding coverage and access to critical medications,” said Christina Rostad MD, pediatric infectious disease associate professor at Emory University and lead investigator of the CD244 trial who provided commentary remotely. “Our team at Emory University is excited to be a part of the celebration and look forward to continuing to explore the potential of Micron Biomedical’s dissolvable microarray vaccine technology.“ About Micron Biomedical Micron Biomedical is the leader in dissolvable microarray-based, drug and vaccine administration technology with a growing pipeline of needle-free versions of previously injectable-only medicines. Micron Biomedical is a clinical-stage life science company on a rapid path to commercializing its proprietary dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection-free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public entities including pharmaceutical and biotech companies, the Gates Foundation, the Centers for Disease Control and Prevention (CDC), PATH and the Georgia Research Alliance. For more information visit www.micronbiomedical.com . Press Contact Shira Derasmo M: +1-917-280-2497 E: pr@micronbiomedical.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/31153de2-caed-4aa2-b291-ebeed2652b70 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d855a883-fb26-47ce-9831-8ef1e0b93f43 
May 13, 2026
Georgia Life Sciences thanks Dr. Marty Makary for his service as Commissioner of the U.S. Food and Drug Administration during a period of significant change across the nation’s health and regulatory agencies.
May 12, 2026
Georgia Life Sciences is pleased to announce Tim Opler as a featured keynote speaker at the 2026 Georgia Life Sciences Summit, taking place August 25-26 at the Sandy Springs Performing Arts Center in Atlanta. A leading voice in biotech investment banking, Tim Opler serves as Managing Director in Stifel’s Global Healthcare Group, where he advises innovative life sciences companies on financing, growth strategy, and market positioning across the healthcare landscape. Tim brings deep insight into the evolving biotech investment environment, emerging industry trends, and the factors shaping the future of life sciences innovation and commercialization. Join us for this timely discussion with one of the industry’s most respected financial leaders as we explore the opportunities and challenges defining the next era of life sciences growth . 
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