FDA, CMS, and healthcare providers' decisions regarding patient safety are advocated for in a plea made to the U.S. Court of Appeals by our website.
In the realm of healthcare and technology, the MedTech Association has been a vocal advocate for change and progress. Over the past year, the organisation has been actively involved in various initiatives, including a virtual workshop series on improving diversity in clinical trials and urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.
The virtual workshop series, held in collaboration with Meharry Medical College from April 6, 2021, to June 30, 2021, aimed to address the underrepresentation of certain demographic groups in clinical trials and explore ways to promote diversity and inclusivity in this crucial area.
Simultaneously, the MedTech Association, along with 67 stakeholder groups, has been urging the CMS to address the challenges posed by the current regulatory framework for accessing breakthrough medical technology. The association believes that the existing process is too slow and bureaucratic, potentially delaying life-saving treatments for patients.
In a related development, the MedTech Association has taken legal action, asking the Court of Appeals for the Third Circuit to vacate a District Court judgment in a False Claims Act case. The appeal raises issues including evidentiary, legal, and instructional errors at the District Court level, as well as the potential unconstitutionality of the qui tam provision of the FCA.
Pat Fogarty, Deputy General Counsel & Senior VP of Legal at the MedTech Association, stated that the District Court's decision gives private parties the power to regulate healthcare, a concern shared by many in the industry.
In another legal matter, Douglas H. Hallward-Driemeier of Ropes & Gray LLP served as Counsel of Record on behalf of the MedTech Association and PhRMA in this case.
The MedTech Association also expressed concerns about risks to patient safety, fewer product choices for beneficiaries, and cost increases if the CMS rule for restarting competitive bidding for durable medical equipment in Medicare stands. The association previously made similar concerns known, urging the CMS to fix "serious flaws" in its proposed rule.
Looking ahead, the MedTech Association continues to advocate for the role of medical technology in healthcare. An op-ed in The Washington Times by Scott Whitaker, president and CEO of the MedTech Association, emphasised the vital role of medtech in the Trump administration's "Make America Healthy Again" initiative.
Moreover, resources for the National Conference of State Legislatures (NCSL) 2025 are available on the MedTech Association's website, covering topics such as diabetes, diagnostics, digital health, government & legislative affairs, and health access.
Christopher L. White, Esq., General Counsel & Chief Policy Officer of the MedTech Association, spoke about the importance of legal, compliance, and regulatory programming at The MedTech Conference 2025.
In schools across the country, thousands of K-12 students returning to school this fall will be subject to a cell phone use ban during instructional hours, but diabetes monitoring is granted an exception. This exemption underscores the importance of technology in managing health conditions and the need for flexible policies that prioritise patient care.
As the MedTech Association continues to advocate for change, it remains committed to improving healthcare in the United States and ensuring that patients have access to the latest, most effective medical technologies.
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