AdvaMed Statement on CMS’s Proposed Rule for Breakthrough Technology Coverage

June 23, 2023

WASHINGTON, D.C. –  AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the recently issued proposed Transitional Coverage for Emerging Technologies (TCET) rule:

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“We’re pleased that CMS has finally issued the TCET notice.  While the draft rule requires further review, we are pleased that CMS recognizes the need to improve the coverage process for seniors. We continue to believe that immediate coverage of FDA approved technologies represents the best path forward to ensure seniors receive the benefits they need and America’s Medtech companies continue to lead the world in medical innovation.  We look forward to reviewing draft rule and working work with CMS and Congress to bring the certainty and transparency to medical innovation that American seniors deserve.”

During the rulemaking process,  AdvaMed wrote to CMS, outlining practical considerations the agency could easily incorporate into its proposed rule, reflecting feedback from the medical technology companies that are developing products and methods to diagnose and treat diseases, improve patient quality of life, and save lives.

From the letter:  “We believe that CMS, in order to advance its health equity and other goals, can and must play a critical role in advancing access to emerging innovations that would improve health outcomes for the array of Medicare beneficiaries it serves. We also believe that we share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients.”

In March, the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act was introduced in the House of Representatives by Reps. Brad Wenstrup (OH-02) and Suzan DelBene (WA-01). In response to the introduction of the bill, Whitaker said,  “Access to innovative, FDA-approved breakthrough technologies is vital for Medicare beneficiaries who are working with their doctors to treat illnesses and live healthy lives. This legislation is an important part of the ongoing reforms that are taking place within CMS to make this a reality for patients.” 


Improving patient access to breakthrough medical technologies is a top priority this year for AdvaMed, highlighted in the organization’s  Medical Innovation Agenda for the 118 th  Congress  earlier this year.  

Georgia Life Sciences Weighs In on PBM and 340B Policy

October 5, 2026
Georgia Life Sciences has submitted written comments to the Georgia House Study Committee on Pharmacy Benefits Managers and Consumers’ Access to Prescription Medications, encouraging greater transparency, accountability, and a focus on measurable patient benefit across the prescription drug system. The comments address both pharmacy benefit manager practices and the federal 340B Drug Pricing Program, emphasizing the importance of understanding where prescription drug savings accrue and whether those savings ultimately benefit patients. The Study Committee continues its work this fall as it develops recommendations for the Georgia General Assembly. Read Georgia Life Sciences’ full comments →

Georgia Life Sciences Joins National Coalition Calling for PAHPA Reauthorization

September 22, 2026
Georgia Life Sciences (GLS) has joined more than 80 organizations from across industry, academia, public health and the biosecurity community in calling on congressional leaders to fully reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) before the end of 2026. Led by the Johns Hopkins Center for Health Security, the coalition urged congressional leaders to advance a comprehensive reauthorization of PAHPA, the federal framework that supports the nation’s ability to prepare for and respond to public health emergencies and other health security threats. First enacted in 2006, PAHPA established and strengthened critical components of the nation’s health security infrastructure, including the Biomedical Advanced Research and Development Authority (BARDA). The law also supports public-private partnerships involved in the research, development, manufacturing and procurement of medical countermeasures, including vaccines, therapeutics and diagnostics. PAHPA’s authorization expired in 2023 and key provisions have since continued through short-term extensions. The coalition is calling for a comprehensive reauthorization that provides greater stability and ensures the nation’s preparedness infrastructure can continue adapting to emerging biological, infectious disease and other health security threats. For the life sciences industry, these programs are particularly important. Partnerships between government and industry can help move promising technologies from research through development and manufacturing while maintaining capabilities needed to respond quickly during an emergency. The Biotechnology Innovation Organization (BIO), also a signatory to the letter, has identified several priorities for reauthorization, including continued authorization of BARDA, the Strategic National Stockpile, Project BioShield and the Pandemic Influenza Program, as well as incentives supporting the development of medical countermeasures. Georgia Life Sciences is proud to join organizations across the country in supporting a strong and sustainable national framework for health security, preparedness and biomedical innovation. Read the coalition letter and view the full list of signatories.

Georgia Life Sciences Urges Protection of Patient Access as Georgia Implements Medicaid Changes

September 14, 2026
Georgia Life Sciences has submitted comments to the Georgia Department of Community Health (DCH) regarding the Georgia Pathways to Coverage program and implementation of new federal Medicaid requirements. As Georgia prepares for these changes, Georgia Life Sciences is urging state leaders to prioritize continuity of care and minimize unnecessary administrative barriers that could delay or disrupt access to medically necessary treatment . This is particularly important for Georgians living with serious, chronic, rare, and medically complex conditions who may rely on ongoing medications, diagnostics, therapies, medical technologies, specialty care, and coordinated treatment plans. Even temporary disruptions in coverage can interrupt care and create additional challenges for patients and families. In its comments, Georgia Life Sciences encouraged DCH to protect continuity of coverage during eligibility and redetermination processes, provide patients and caregivers with clear and timely information, minimize unnecessary administrative burdens, and establish appropriate safeguards when a coverage disruption could interrupt an established course of treatment. “As Georgia implements these new federal requirements, we want to ensure that patients remain at the center of the process,” said Maria Thacker Goethe, MPH, President & CEO of Georgia Life Sciences. “Administrative changes should not become barriers between patients and the care they need. Protecting continuity of care is particularly important for Georgians managing serious and complex health conditions.” Read Georgia Life Sciences’ full comments to DCH here.
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