Read ML Strategies’ in-depth analysis of how the results of the November 2024 elections are likely to shape policy in many areas, including energy & sustainability, US-Canada cross-border issues, taxation, health care, international trade, infrastructure, consumer product safety, and financial services, and what to expect in the upcoming lame duck session of Congress.

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.

On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.

Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.