AdvaMed Statement on Final TCET Notice

WASHINGTON – AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the final Transitional Coverage for Emerging Technologies (TCET) notice from the Centers for Medicare and Medicaid Services (CMS):

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering. The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection. While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing HR 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it.”


Read at AdvaMed: https://www.advamed.org/industry-updates/news/advamed-statement-on-final-tcet-notice/

CMS released the TCET Final Notice; its text is here.


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 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.
By Maria Thacker Goethe September 5, 2025
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