Holland & Knight Health Dose: October 21, 2025

Looking Ahead

As the government shutdown enters its fourth week, there is no clear end in sight. Democrats continue to insist that any bill to reopen and fund the government include an extension of the advanced premium tax credits (APTCs) for plans through the Affordable Care Act (ACA), which are set to expire at the end of 2025 unless the U.S. Congress votes to extend them. With the Open Enrollment Period (OEP) for plans through the ACA beginning Nov. 1, 2025, during which consumers may enroll in or change their health plans, the stakes are high. Many consumers across the nation have already begun the "window shopping" period, which is when consumers may review plan prices, coverage and benefits before making their plan selection. Reports of premiums slated to increase by double or triple have been featured in the news and on social media, highlighting many Democrats' concerns that an extension of the APTCs should be considered without further delay. Republicans, however, believe the government must first be reopened before negotiations around healthcare – especially the APTCs – may transpire. Many Republicans wish to see changes made to the APTCs such as changing eligibility criteria and larger reforms to healthcare programs writ large considered by Congress.

The U.S. Senate remains in session and will vote on the same U.S. House of Representatives-passed continuing resolution (CR) and the CR proposed by Senate Democrats – both of which have failed to garner the necessary 60 votes required for passage more than 10 times each. Meanwhile, the House remains out of session. House Speaker Mike Johnson (R-La.) emphasized that the chamber has already done its part by passing a CR and that the Senate must act before the House returns. Members of the House have been asked to be on a 48-hour notice to return to Washington, D.C., should the Senate pass legislation to reopen the government.

Upcoming Events

The Senate Special Committee on Aging will hold a hearing on Oct. 22, 2025, titled "Modernizing Health Care: How Shoppable Services Improve Outcomes and Lower Costs."

The Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing on Oct. 23, 2025, titled "The 340B Program: Examining Its Growth and Impact on Patients." Michelle Rosenberg, director of healthcare at the U.S. Government Accountability Office (GAO), and Dr. Aditi Sen, chief of the Health Policy Studies Unit at the Congressional Budget Office (CBO), are scheduled to testify.

Administrative Updates

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's 2025 Executive Orders: Updates and Summaries" tracking chart.

Personnel Update

The Senate confirmed several of President Donald Trump's nominees on Oct. 7, 2025, to positions at the U.S. Department of Health and Human Services (HHS): Brian Christine to be assistant secretary for health, Michael Stuart to be general counsel, Gustav Chiarello to be assistant secretary for financial resources and Alex Adams to be assistant secretary for family support. All were confirmed on a party-line vote as part of a package of 107 nominees.

Additional Drug Pricing Deals Announced, More Likely to Come

President Trump announced two new drug pricing agreements on Oct. 11 and Oct. 16, 2025. The announcements mirror similar frameworks announced within the past several weeks in which the manufacturer will sell certain medicines to Medicaid programs at lower prices and through the government's direct-to-consumer assistance page to help connect patients with manufacturer discount programs. In return, manufacturers will receive a reprieve from potential pharmaceutical tariffs for three years. What is notable about the drug pricing agreement announced on Oct. 16, 2025, is that the manufacturer was also one of the first nine to receive a Commissioner's National Priority Voucher (CNPV), a new program established by the U.S. Food and Drug Administration (FDA) to accelerate review timelines for certain drug and biological products.

Legislative Updates

Coding System Under Scrutiny

Sen. Bill Cassidy (R-La.), chair of the Senate Committee on HELP, ramped up scrutiny of a major medical association's role in managing the Current Procedural Terminology (CPT) system, which he describes as a government-backed monopoly that drives up healthcare costs. Sen. Cassidy argues that the association's practice of charging licensing fees for CPT code access creates a hidden tax on the healthcare system, with costs ultimately passed on to patients and providers. In the letter, Sen. Cassidy requested financial transparency and questioned whether revenue from CPT licensing is being used to support efforts around diversity, equity and inclusion and gender-affirming care. He also called these efforts anti-patient and anti-science and said they warrant congressional oversight.

The investigation could reignite debate over whether CPT codes should remain under association control or shift to a more open, government-managed framework. The letter also follows previous efforts in proposed rules to reduce reliance upon data from the Relative Value Scale Update Committee surveys, which historically have low response rates and address concerns that certain specialty physicians are overvalued in comparison to other physician group types.

Senior Democrats Seek Answers from Medicaid Contractors

Senate Committee on Finance Ranking Member Sen. Ron Wyden (D-Ore.) and members Sen. Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.) and Raphael Warnock (D-Ga.) sent letters on Oct. 10, 2025, to four major companies that work with state Medicaid programs to verify eligibility. The letters detail several pages of questions regarding terms of previous and existing contracts, as well as questions regarding compliance and services rendered. The letters come as states are ramping up preparations to implement and comply with changes to Medicaid eligibility following the passage of H.R.1, the One Big Beautiful Bill Act (OBBB).

BIOSECURE Act Included in NDAA

The Senate adopted an amendment to the National Defense Authorization Act (NDAA) on Oct. 9, 2025, that incorporates an amended version of the BIOSECURE Act as part of the defense package. The BIOSECURE Act would prohibit federal contracts with certain biotechnology providers connected for foreign adversaries, such as the People's Republic of China (PRC). The legislation failed to pass during the 118th Congress. The Senate-passed package will now need to be reconciled with the House-passed version of the defense bill.

The new version of the bill that was adopted as an amended includes several notable changes from the bill as amended in the previous Congress. It does not implicate specific companies of concern and instead refers to a list of entities as published by the U.S. Department of Defense. The definition of "biotechnology equipment or service" carves out specific technologies used in the manufacturing and development of certain biotechnology products.

Regulatory Updates

CDC ACIP: COVID-19 Vaccination During Pregnancy

The Centers for Disease Control and Protection's (CDC) Advisory Committee on Immunization Practices (ACIP) has quietly expanded access to COVID-19 vaccines for pregnant individuals. Though the panel did not explicitly vote on pregnancy-specific recommendations, its September 2025 decision to endorse shared clinical decision-making for adult vaccination has effectively reopened access. Pharmacies can now administer the vaccine to pregnant patients, and insurers are required to cover the shots without cost-sharing. This move reverses a prior directive from HHS Secretary Robert F. Kennedy Jr., who had removed the vaccine from the immunization schedule for pregnancy.

CMS Announces Claims Hold for Certain Services After Oct. 1, 2025

The Centers for Medicare & Medicaid Services (CMS) released updated guidance on Oct. 15, 2025, about "holding claims" during the government shutdown. In the guidance, CMS notes it has instructed all Medicare Administrative Contractors (MACs) to temporarily hold claims with dates of service of Oct. 1, 2025, and later for services impacted by the expiration of certain healthcare extenders as passed as part of the Full-Year Continuing Appropriations and Extensions Act of 2025. Per CMS, this includes certain telehealth claims, ground ambulance transport claims and all federally qualified health center (FQHC) claims. Providers may continue to submit claims, though payment will not be released until the hold is lifted.

FDA Guidance Agenda: RWE and PCCPs

FDA's Center for Devices and Radiological Health (CDRH) has released its fiscal year (FY) 2026 guidance agenda, spotlighting two high-impact areas: Real-World Evidence (RWE) and Predetermined Change Control Plans (PCCPs). The agency aims to finalize guidance that would streamline regulatory pathways for artificial intelligence (AI)-enabled medical devices and expand the use of RWE in drug development and post-market safety. These efforts reflect FDA's broader push to modernize oversight and reduce regulatory burdens while maintaining scientific rigor.

FDA Announces Initial Group to Receive CNPV

FDA announced on Oct. 15, 2025, that nine awardees will receive the CNPV, designed to accelerate review timelines for products that meet a large unmet public health need. Products selected include:

• Pergoveris for infertility
• Teplizumab for Type I diabetes
• Cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• Cenegermin-bkbj for blindness
• RMC-6236 for pancreatic cancer
• Bitopertin for porphyria
• Ketamine for domestic manufacturing of a critical drug for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic

It will be critical to monitor when these applications seek to redeem their voucher and the speed of reviews, particularly amid the ongoing government shutdown, as FDA continues to operate on funding derived from user fees that were collected prior to the government's closure. FDA also noted that it intends to announce additional awardees in the coming months, representing a sizable increase in the program over the small number of recipients that were intended to be selected.

HHS OIG Releases Report on Bundled Payment Rates for Opioid Use Disorder

The HHS Office of the Inspector General (OIG) released a report assessing the impact of the opioid crisis on beneficiaries enrolled in Medicare Part B. The report was directed following passage of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), passed in 2018. The SUPPORT Act authorized the CMS to make bundled payments to opioid treatment programs (OTPs) for the provision of certain opioid use disorder (OUD) treatment. The audit covers 2.7 million Part B claims and the OIG assessed a sample of 100 claim lines from among three Healthcare Common Procedure Coding System (HCPCS) codes: G2067 (weekly bundle with methadone), G2068 (weekly bundle with buprenorphine) and G2074 (weekly bundle without a drug) from dates of service between Jan. 1, 2020, and Sept. 30, 2022.

The report found that bundled payments for OUD treatment services were generally higher than OIG-calculated payment amounts for services provided to enrollees. In addition, the report found that Medicare could have garnered an additional $300 million in savings if the bundled rate developed by CMS had reflected the types and frequency of services provided. The OIG report recommends CMS consider revising its methodology for determining nondrug components of the bundled payment rate and within statutory authority consider developing new HCPCS codes for weekly bundles.

Legal Updates

Court Directs Trump Administration to Halt RIFs During Shutdown

A federal judge ruled in favor of several unions representing some federal employees on Oct. 16, 2025, and directed the Trump Administration not to proceed with reductions in force (RIFs) during the government shutdown. More than 4,000 employees were targeted by RIFs announced on Oct. 10, 2025, including nearly 1,000 HHS workers, though a number of them were ultimately brought back after receiving RIF notices in error. It is likely the case will continue to play out in federal courts as long as the shutdown is in effect.

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