From a government shutdown halting FDA approvals to the looming expiration of ACA subsidies threatening to raise insurance premiums for millions, the American healthcare system is facing a perfect storm. These mounting US healthcare policy challenges are creating unprecedented uncertainty for patients, providers, and innovators alike. In this episode, we're joined by healthcare regulation and policy expert Matt Wetzel, a partner at Goodwin Procter LLP, to dissect the interconnected crises plaguing Washington, D.C. and what they mean for the future of your healthcare.

We connect the dots between the federal shutdown, expiring ACA enhanced premium tax credits, clandestine pharmacy benefit manager (PBM) practices, and Medicare's latest payment cuts. Why can't Washington compromise, and who is feeling the most pain? We explore the real-world consequences, including delays for companies seeking approvals for new drugs and devices, the degradation of hospital payer mix due to rising uninsured rates, and the political maneuvering that leaves everyday Americans caught in the middle. This discussion on US healthcare policy challenges uncovers the systemic dysfunctions, from legislative gridlock to the "wrecking ball" approach to policymaking that prioritizes disruption over stability.

This episode provides a comprehensive breakdown of the most pressing issues in healthcare today. We uncover the truth behind Pharmacy Benefits Managers (PBMs) and the bipartisan push for PBM reform, exposing their fundamental conflicts of interest, the dirty tricks of "spread pricing" on generic drugs, and why their business model drives up costs for everyone. We also analyze the controversial Medicare efficiency adjustment included in the latest Medicare Physician Fee Schedule—a "lazy" blanket cut that penalizes specialists and creates further uncertainty in the medical technology market. If you want to understand the forces driving up your insurance costs and creating chaos in the US healthcare system, this is a must-watch conversation that unpacks the complex US healthcare policy challenges we all face.

About Our Guest:
Matt Wetzel is an attorney and Partner at Goodwin Procter LLP, based in Washington D.C. He is a leading expert in medical device and healthcare regulation, working with numerous biotech, medtech, and digital technology companies. As a seasoned health policy commentator, Matt provides deep insights into the administrative and regulatory hurdles impacting the healthcare industry, from the FDA and CMS to the NIH.

Timestamps:
(00:00) Introduction: A System in Crisis
(01:55) The Government Shutdown's Widespread Impact on Healthcare
(05:05) How the Shutdown Halts FDA Approvals for New Drugs & Devices
(09:25) The Crushing Weight of Uncertainty on the Healthcare Business Community
(11:34) The Looming Expiration of ACA Enhanced Premium Tax Credits
(14:28) Why Can't Congress Agree on Extending ACA Subsidies?
(20:09) The Hidden Bureaucracy Driving Up Health Insurance Costs
(26:15) Decoding PBM Reform: Conflicts of Interest and Hidden Costs
(33:24) The PBM Conflict of Interest: Serving Two Masters
(37:50) PBM Trick Explained: What is "Spread Pricing"?
(41:00) The "Halloween Surprise": Unpacking the Medicare Efficiency Adjustment
(49:09) What's Next? Biotech, National Security, and Future Healthcare Legislation

Learn More From Our Guest / Episode Resources:

• Learn more about Matt Wetzel's work at Goodwin Procter LLP