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.

The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess and before political “silly season” officially kicks in ahead of the upcoming mid-term elections in November. Here’s our latest update on what you can expect in Congress during the July work period.

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.

Read about the U.S. House Ways and Means Committee’s proposed tax legislation intended to partially fund the $3.5 trillion Build Back Better Act to fund Democratic priorities.

The second half of 2021 will be a busy stretch for Congress. In addition to the typical must-pass legislation, Democrats controlling both chambers and the White House are committed to several big spending bills, too. This preview is a rundown of these bills, what’s included in them, and how we can expect them to play out.

Since the Democrats reclaimed control of the House of Representatives in 2018, barrels of ink have been spilled on the topic of “congressionally-directed spending”. Better known as earmarks, this funding mechanism allows Members of Congress to send money directly to projects identified in their districts, largely bypassing the federal bureaucracy and its protracted grant application process. For more than a decade, the Congress has banned the practice of including congressionally-directed funding in spending bills. Now, Democrats in control of both chambers and the White House are poised to bring earmarks back. On March 17th, House Republicans voted to reverse the GOP Conference’s ten year-old ban on congressionally directed spending, paving the way for Members from both parties to make requests in upcoming spending and infrastructure bills.