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)

By Maria Thacker Goethe April 18, 2025
The Science & Community Impacts Mapping Project (SCIMaP) shows how proposed federal funding cuts lead to reduced economic activity and job losses nationwide.
By Sheran Brown April 10, 2025
Georgia Life Sciences Selects Fulton County Schools Innovation Academy Student as the 2025 Georgia BioGENEius Winner Sandy Springs & Rockmart Teens Take Top Honors in Statewide Science Competition Atlanta, GA (April 4, 2025) – Georgia Life Sciences today named Bhavya Alapati , a junior at Fulton County Schools Innovation Academy, as the winner of the 2025 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. Eleven students from across Georgia competed for this year’s title and cash prize. Bhavya’s project investigated a novel method of identifying strokes using a device she created called SpectroStroke, a small-scale spectrophotometer, to detect homocysteine, an amino acid product that is associated with stroke. Bhavya identified the ability of homocysteine to be detected using Ellman’s reagent, which reacts with the free sulfhydryl group on the molecule to produce a yellow color. Bhavya created a wearable patch that contains the Ellman’s reagent. Then, she designed the SpectroStroke to be able to detect the color change when the patch is exposed to elevated levels of homocysteine. Bhavya’s SpectroStroke can detect normal levels of homocysteine up to extremely high levels seen in those experiencing a stroke. The ability to detect a stroke earlier would reduce damage and long-term effects of the condition. A future iteration of the SpectroStroke would include real-time monitoring capabilities to help track changing homocysteine levels. "Supporting and celebrating outstanding research and innovation in biotechnology is vital for the future of science and medicine. The Georgia BioGENEius Challenge not only encourages the brightest young minds to explore their potential but also nurtures the next generation of leaders who will drive groundbreaking advancements in biotechnology,” said Georgia Life Sciences President and CEO Maria Thacker-Goethe. “By recognizing and empowering these students, we are helping to shape a future where innovation thrives and the possibilities for improving lives are endless. Well done, Bhavya!” Georgia Life Sciences also congratulates the Georgia BioGENEius runner-up, Shelby Kendrick , who is a senior at Paulding County High School in Dallas, GA. Shelby’s research investigated the ability of Aspergillus terreus, a fungus found in soil, to degrade pre-treated polypropylene plastic (PP). This fungus has been discovered to produce high concentrations of degrading enzymes and raises the moisture level of its substrate. Shelby isolated the fungus from soil samples and confirmed the species using PCR amplification and DNA barcoding. Samples of polypropylene were pre-treated with 75% ethanol and UV exposure, then placed in a liquid culture of A. terreus in Minimal Salt Medium (MSM) media, and the culture was incubated for 23 days. At the end of the trial period, PP samples were analyzed using Scanning Electron Microscopy. These samples showed changes in their surface layer, indicating evidence of biodegradation. Polypropylene plastic is found in household items such as plastic cups and is a known problem in the environment due to its inability to degrade. Shelby’s future research on the use of A. terreus for biodegradation includes optimizing degradation conditions and assessing methods of application in the environment. Judging the 2025 Georgia BioGENEius Challenge were Ralph L. Cordell, CDC, and Alex Harvey, ViaMune. Cash prizes were awarded to Bhavya and Shelby. # # # About Georgia Life Sciences Georgia Life Sciences, founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization working to improve access to innovative discoveries that have lifesaving impact. The association connects business, academia, government, and other allied entities involved in the application of life sciences products to fuel growth and collaboration through policy development, community programs, national industry initiatives, and a portfolio of educational and networking events. Learn more at galifesciences.org.
By Maria Thacker Goethe April 9, 2025
Emerging biotechnology is key for U.S. to remain dominant and secure future economic growth in a new era of global competition
MORE POSTS