Georgia Bio Sign-on to State Medical Technology Alliance HHS & CMS Letter

Georiga Bio sign-on to the State Medical Technology Alliance (SMTA) letter to U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid. Please see the language below.


The Honorable Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

The Honorable Seema Verma
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244


Dear Secretary Azar and Administrator Verma:

As members of the State Medical Technology Alliance (SMTA), we are state and regional life sciences associations representing biotechnology, medical device companies, universities, research institutions, and venture capital firms across the country, all dedicated to developing and delivering life-enhancing and life-saving products, we write to express our strong support for your leadership in the U.S. Department of Health and Human Services’ (HHS) efforts to provide coverage for transformative medical devices that are approved as breakthrough devices by the FDA.

The COVID-19 pandemic highlighted the need for our nation’s health care system to better align care for patients.  We commend HHS for taking swift action to create appropriate waivers and incentives across different health care stakeholders to better address this devastating disease.  Providing patients with access to breakthrough devices would further this push to align care for patients by promoting innovation and providing patients with the latest in life-changing medical technology.

The medical technology industry is an important and thriving sector in the U.S. economy, creating jobs in all 50 states and representing a sizable portion of the nation’s Gross Domestic Product.  The industry is responsible for about 1.9 million jobs in the U.S. and an economic output of approximately $381 billion annually.

Access to state-of-the art medical technology and diagnostics can help to improve care and patient outcomes, and CMS has acknowledged the value of breakthrough products by including a Breakthrough Product Pathway for new technology add-on payments (NTAP) in the Final Rule on the FY 2020 Inpatient Prospective Payment System. 

We commend HHS and CMS for these efforts and urge you to take the next step by providing coverage for all medical devices that are approved and cleared as FDA-designated breakthrough in all settings.  Providing this needed certainty will help ensure the next round of truly life-changing innovation can get to the patients who need them as quickly as possible.

As members of the SMTA, we look forward to working with the Administration to finalize this critical effort.



Sincerely,


Arizona BioIndustry Association (AZBio)

Biocom: Life Science Association of California

BioFlorida

BioForward Wisconsin

BioOhio

Bioscience Association of West Virginia (BioWV)

BioUtah

California Life Sciences Association (CLSA)

Colorado BioScience Association (CBSA)

Florida Medical Manufacturers Consortium (FMMC)

Georgia Bio

Healthcare Institute of New Jersey (HINJ)   

Illinois Biotechnology Innovation Organization (iBIO)

Indiana Health Industry Forum (IHIF)

Indiana Medical Device Manufacturers Council (IMDMC)

Iowa Biotechnology Association (IowaBio)

Kentucky Life Sciences Council

Life Sciences Pennsylvania

Life Science Tennessee

Life Science Washington

Massachusetts Medical Device Industry Council (MassMEDIC)

Medical Alley Association

MedTech Association New York

Michigan Biosciences Industry Association (MichBio)

Mississippi Biotechnology Association

Missouri Biotechnology Association (MOBIO)

NCBIO

SCBIO

Southeast Life Sciences

Texas Healthcare & Bioscience Institute (THBI)

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Wednesday, July 8, 2026 - Georgia Life Sciences is encouraged by the recent federal court decision issuing a preliminary injunction that prevents Colorado from implementing its upper payment limit for Amgen’s Enbrel, a patented treatment for rheumatoid arthritis and other autoimmune conditions. The ruling underscores a critical concern for the life sciences sector: state-level price controls, particularly those applied to patented medicines, raise significant legal questions and can create uncertainty for the innovation ecosystem that supports the development of new treatments. Colorado’s Prescription Drug Affordability Board had sought to impose the nation’s first upper payment limit on a specific prescription medicine. While the goal of improving affordability for patients is important and shared across the healthcare ecosystem, government-set price caps are the wrong approach. They risk undermining investment in biomedical innovation without guaranteeing that savings will reach patients at the pharmacy counter. As more states consider Prescription Drug Affordability Boards with authority to impose upper payment limits, policymakers should proceed with caution. These boards can add costly and complex layers of bureaucracy while creating uncertainty for companies working to discover, develop, manufacture, and deliver new therapies. To date, PDABs have not demonstrated that they meaningfully lower out-of-pocket costs for patients. GLS supports policies that improve affordability and access in ways that directly benefit patients. Rather than pursuing government-set price controls, policymakers should focus on reforms that address the real drivers of patient costs, including ensuring manufacturer rebates are passed through to patients, increasing transparency across the drug supply chain, promoting competition through generics and biosimilars, and expanding affordable insurance coverage. Patients need solutions that lower costs where they feel them most, at the pharmacy counter. Georgia Life Sciences will continue to advocate for patient-focused policies that improve access, preserve innovation, and support a strong life sciences ecosystem. Source: The court blocked Colorado’s first-in-the-nation Enbrel UPL through a preliminary injunction, with the cap set to take effect in January 2027. More here: https://www.reuters.com/legal/litigation/judge-blocks-colorados-first-of-its-kind-price-cap-amgens-enbrel-2026-07-01/
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