Golden Helix Awards recognize achievements in Georgia's life sciences sector

August 20, 2025 - The Honorable Dr. Mehmet Oz Administrator Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 A dm 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

“If you're not affiliated with a university, you can't really access their labs,” said Eddie Lai, director of business development at venture capital firm Portal Innovations. “If you're trying to build your own facility, that costs a lot of money.”