Health Headlines: November 2025

House Democrats have introduced the Lowering Drug Costs for American Families Act (H.R. 6166), which builds on the Inflation Reduction Act’s Medicare drug price negotiation program. The bill would increase the number of drugs selected annually for negotiation from 20 to 50 and extend those negotiated prices to the commercial insurance market, including insurance plans under the Affordable Care Act. The legislation also proposes capping out-of-pocket costs for insulin at $35 per month for those with commercial insurance and repealing a loophole that allows manufacturers to avoid negotiation by claiming orphan drug designation on widely used drugs. The bill further seeks to apply inflation rebates to drugs in the commercial market, mirroring Medicare’s penalties for price hikes above inflation. If enacted, these provisions would broaden federal authority over drug pricing, aiming to curb costs for both public and private payers.

The Drug Enforcement Administration (DEA) has indicated, via a new rule titled “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” posted to the Office of Management and Budget registry, plans for another temporary extension of COVID-era telemedicine flexibilities that allow clinicians to prescribe Schedule II–V controlled substances via telehealth without an initial in-person visit. These flexibilities, first introduced during the pandemic, were set to expire on December 31, 2025. The new rule is expected to extend the telemedicine flexibilities through the end of 2026 and will maintain the status quo while the DEA and the Department of Health and Human Services work toward a permanent regulatory framework. The full text of the new rule is not yet available, and Goodwin will continue to monitor the rule for any developments.

In our previous Alert, we discussed HRSA’s new 340B Rebate Model Pilot Program, which shifts from upfront drug discounts to post-purchase rebates. HRSA has officially approved eight drugmakers’ plans for participation, covering ten widely used drugs: Eliquis, Enbrel, Entresto, Farxiga, Imbruvica, Januvia, Jardiance, multiple NovoLog and Fiasp products, Stelara, and Xarelto. These plans will take effect January 1, 2026, with Novartis’ Entresto scheduled for April 1, 2026. All approved plans will operate through the Beacon platform, requiring 340B Covered Entities to submit pharmacy and medical claims data within 45 days of dispensing to receive rebates within 10 days.

The pilot, which will run for at least one year, is intended to assess the feasibility of rebate-based pricing and inform future 340B reforms. HRSA emphasized that manufacturers must bear administrative costs and maintain auditable records. As noted in our September issue of Health Headlines, there was advocacy by provider groups and bipartisan Congressional groups to delay implementation. Despite the resistance, HRSA has moved forward with the pilot program, framing the initiative as a way to improve transparency and address duplicate discount issues under the Inflation Reduction Act.

The Senate Finance Committee held a hearing on November 19 where the Committee examined rising healthcare costs and the impending expiration of enhanced Affordable Care Act (ACA) subsidies at the end of the year. Democrats advocated for a one-year extension of the subsidies to prevent significant premium increases during open enrollment, while Republicans opposed the extension, citing concerns about long-term cost impacts. Instead, GOP members proposed expanding Health Savings Accounts as an alternative approach to affordability, emphasizing consumer flexibility and control over healthcare spending. The discussion also touched on broader cost pressures, including projected premium increases for employer-sponsored coverage and bipartisan interest in pharmacy benefit manager reform to address drug pricing practices.

The Centers for Medicare & Medicaid Services (CMS) recently highlighted progress on its interoperability initiative during a Health Tech Ecosystem Connectathon, unveiling a beta version of its planned National Provider Directory. The directory, designed to improve data exchange and patient access, aims to serve as a centralized source for provider information across Medicare and other programs. CMS has also awarded contracts to technology firms to develop proof-of-concept models. The initiative aligns with broader efforts under the CMS Interoperability Framework to enhance patient access, streamline data sharing, and reduce administrative burden.

At the same time, CMS faces scrutiny over the accuracy of its current Medicare Advantage provider directory tool, which launched during open enrollment. Reports indicate the temporary directory contains conflicting and duplicative information, raising concerns about consumer decision-making and potential out-of-network costs. Senators Jeff Merkley (D-OR) and Ron Wynde (R-OR) have pressed CMS for corrective measures and transparency on its timeline for improvements. These issues underscore the complexity of provider data management and the importance of ensuring reliability as CMS advances toward a national directory that could eventually become an authoritative source for provider data across payers.