McDermott+ Check-Up: December 19, 2025 - McDermott+

McDermott+ Check-Up: December 19, 2025

THIS WEEK’S DOSE


  • House continues debate on healthcare legislation. Central to the debate is how to handle the December 31, 2025, expiration of the enhanced advanced premium tax credits (APTCs).
  • House passes gender-affirming care legislation. One bill would prohibit federal Medicaid funding for gender-affirming care for youth, while the other would criminalize the provision of gender-affirming care.
  • House Energy and Commerce Oversight Subcommittee examines biosecurity and AI. During the hearing, Ranking Member Pallone (D-NJ) called a motion to subpoena US Department of Health and Human Services (HHS) Secretary Kennedy to testify on his threats to biosecurity. The motion was rejected on party lines.
  • Joint Economic Committee discusses how to improve healthcare outcomes and reduce costs. The hearing was largely a continuation of previous debates on how to address the enhanced APTCs and lower consumer healthcare costs.
  • Senate Finance Committee Ranking Member Wyden introduces organ transplantation system reform legislation. The legislation follows increased legislative scrutiny on organ procurement organizations.
  • HHS issues proposed rules, takes action on gender-affirming care for youth. HHS aims to limit federal funding of gender-affirming care for youth, restrict the provision of such care, and increase federal research on individuals who detransition.
  • CMS Innovation Center announces LEAD Model. The Long-term Enhanced ACO Design (LEAD) model aims to succeed the ACO REACH model following its conclusion at the end of 2026.
  • ASTP/ONC issues RFI on AI in clinical care. The request for information (RFI) focuses on how the agency can support the rapid adoption and use of artificial intelligence (AI).
  • CMS Innovation Center releases RFA for ACCESS Model. The request for applications (RFA) deadline for the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model is April 1, 2026, for a performance period starting July 5, 2026.

CONGRESS


House continues debate on healthcare legislation. Late last week, House Republican leadership unveiled their new healthcare proposal in the midst of ongoing debate on how to address the Affordable Care Act’s expiring enhanced APTCs. H.R. 6703, the Lower Health Care Premiums for All Americans Act, notably does not include an enhanced APTC extension and would not expand or create any new federal funds for health savings accounts, which was the key feature of the Crapo-Cassidy bill the Senate considered last week. H.R. 6703 would instead:

  • Expand access to association health plans for small businesses and self-employed individuals.
  • Codify and rename individual coverage health reimbursement arrangements to “custom health option and individual care expense arrangements,” or CHOICE plans.
  • Preempt state limitations on stop loss insurance.
  • Implement certain pharmacy benefit manager reforms.
  • Permanently appropriate cost-sharing reduction (CSR) payments, including prohibiting CSR usage by plans covering abortions.

The Congressional Budget Office scored the bill as saving $35.57 billion over 10 years while increasing the number of uninsured individuals by 100,000 per year. Focus quickly turned from the actual vote on H.R. 6703 after House Republican leadership reneged on a commitment to allow moderate Republicans an amendment vote on extending enhanced APTCs. The House Rules Committee on December 16, 2025, rejected numerous amendments to H.R. 6703, including Rep. Fitzpatrick’s (R-PA) proposed amendment to extend the enhanced APTCs for two years with reforms, thereby blocking those amendments from floor consideration.

On December 17, 2025, four moderate Republicans – Reps. Fitzpatrick, Mackenzie (PA), Lawler (NY), and Bresnahan (PA) – broke ranks and signed a Democratic-led discharge petition, resulting in the 218 signatures needed to force a floor vote on a clean three-year extension of the enhanced APTCs. Rep. Fitzpatrick stated, “the only policy that is worse than a clean three-year extension without any reforms, is a policy of complete expiration without any bridge. Unfortunately, it is House leadership themselves that have forced this outcome.”

A discharge petition is subject to a procedural waiting period, and therefore the APTC vote will not occur until January 2026. A bipartisan group of House and Senate members are working toward a compromise that might increase the possibility that the Senate will act, since it rejected a clean three-year extension earlier this month.

Ultimately, H.R. 6703 passed by a 216 – 211 vote, with only Rep. Massie (R-KY) breaking from his party to oppose the legislation. The bill is not expected to move forward in the Senate.

Without passage of a bill to extend the enhanced APTCs this year, they will expire after December 31, 2025. Any legislation to extend them will have to be considered in 2026 with a retroactive fix, as coverage begins January 1, 2026.

House passes gender-affirming care legislation. H.R. 3492, the Protect Children’s Innocence Act, was introduced by Rep. Marjorie Taylor Green (R-GA) and advanced out of the House Judiciary Committee in June 2025 by a party-line vote. H.R. 3492 would criminalize the provision of gender-affirming care, as defined in the bill, to youth under the age of 18. Any individual providing such care would be subject to a fine and/or a prison sentence not to exceed 10 years. Individuals who facilitate or consent to “female genital mutilation” of a minor, as defined in the bill, or who transport an individual to such care, would also be subject to a fine and/or a prison sentence not to exceed 10 years. The bill includes explicit exceptions. It passed by a 216 – 211 vote. Democrats Cuellar (TX), Davis (NC), and Gonzalez (TX) joined Republicans to vote yes, while Republicans Evans (CO), Fitzpatrick, Kennedy (UT), and Lawler joined Democrats in opposition.

H.R. 498, the Do No Harm in Medicaid Act, was introduced by Rep. Dan Crenshaw (R-TX). A similar version of this legislation was included in a previous version of H.R. 1, the One Big Beautiful Bill Act, but was ultimately removed from that package because it violated the Byrd rule. H.R. 498 would prohibit federal Medicaid funding for gender-affirming care, as defined in the bill, for youth under the age of 18. The bill includes explicit exceptions. It passed by a vote of 215 – 201, with Reps. Cuellar, Davis, Gonzalez, and Gluesenkamp-Perez (D-WA) joining all Republicans to vote yes.

It remains to be seen if these bills will advance in the Senate and how their passage would interact with HHS’s proposed gender-affirming care rules (discussed below).

House Energy and Commerce Oversight Subcommittee examines biosecurity and AI. During the hearing, Republicans raised concerns about political adversaries gaining access to bioweapons and potential AI misuse. Republicans noted their support of the Trump administration’s AI policies. Democrats emphasized that the biggest threat to biosecurity and public health was HHS under Secretary Kennedy. They used the current measles outbreak to illustrate that the administration’s funding and staff cuts made HHS less prepared for an outbreak. Committee Ranking Member Pallone (D-NJ) called a motion to subpoena Secretary Kennedy to testify in front of the committee on this issue, but the motion was rejected on party lines.

Joint Economic Committee discusses how to improve healthcare outcomes and reduce costs. During the hearing, Republicans expressed interest in understanding how Congress could reduce insurance fraud and increase access to innovative technologies, while Democrats focused on the need to extend the enhanced APTCs and explore different insurance models. Both parties were interested in learning how preventative care measures could be leveraged t o lower healthcare costs.

Senate Finance Committee Ranking Member Wyden introduces organ transplantation system reform legislation. Senate Finance Committee Ranking Member Wyden (D-OR) introduced legislation that would strengthen federal oversight of organ procurement organizations (OPOs) and create civil penalties for OPOs that violate safety or fairness standards. It would also clarify the process for certifying and recertifying OPOs, including allowing new OPOs to enter the system, and would require hospitals to maintain written protocols, including reevaluation when a patient still shows signs of life. The bill would give HHS clearer authority to decertify poorly performing OPOs and require OPOs to adopt and report conflict-of-interest policies. A section-by-section summary of the legislation can be found here.

ADMINISTRATION


HHS issues proposed rules, takes action on gender-affirming care for youth. The Centers for Medicare & Medicaid Services (CMS) and the HHS Office of Civil Rights (OCR) released several proposed rules, followed by an event with HHS Secretary Kennedy, CMS Administrator Oz, and other HHS personnel.

The first CMS proposed rule would prohibit federal Medicaid and Children’s Health Insurance Program funding for gender-affirming care services provided to youth, but notes that states could provide such care with state-only funds. The second CMS proposed rule would amend the requirements for certified hospitals to participate in the Medicare and Medicaid programs by limiting the performance of sex-rejecting procedures on children (defined as under 18). Comments are due on both rules by February 17, 2026.

The OCR proposed rule would amend the definition of disability to exclude “gender identity disorders not resulting from physical impairments,” and comments are due January 20, 2026. The rules cite previous Trump administration actions regarding gender-affirming care for minors, including the original executive order (EO), an HHS report on best practices for gender dysphoria treatment, and a quality and safety special alert memo for hospitals.

Additional gender-affirming care actions from HHS include US Food and Drug Administration (FDA) warning letters to breast binder manufacturers, a public health message from Assistant Secretary for Health Brian Christine, and an announcement that the National Institutes of Health will prioritize funding research related to individuals who detransition. HHS also issued a declaration that finds sex-rejecting procedures for children and adolescents are neither safe nor effective as a treatment modality for gender dysphoria, gender incongruence, or other related disorders in minors and fails to meet professional recognized standards of health care.

CMS Innovation Center announces LEAD Model. The LEAD Model is the Innovation Center’s next-generation accountable care model, designed to succeed ACO REACH following its conclusion at the end of 2026. LEAD is a voluntary, 10-year model (January 1, 2027 – December 31, 2036). The model is intended to address persistent barriers to accountable care organization (ACO) participation for small, rural, independent, and safety-net providers, while deepening accountability for high-needs populations, including beneficiaries who are dually eligible for Medicare and Medicaid. CMS expects to release a request for applications in March 2026. LEAD builds on lessons from prior CMS ACO initiatives and will include two voluntary risk-sharing options. The model includes alignment with the Make America Healthy Again initiative.

ASTP/ONC issues RFI on AI in clinical care. The RFI from the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) follows previous RFIs from other HHS subagencies, the President’s AI Action Plan, and the HHS AI Strategy. It seeks comment on specific questions and more broadly on how HHS regulations impact AI adoption and use for clinical care, on payment policy changes that ensure payers have the incentive and ability to promote access to high value AI clinical interventions, and on ways HHS may invest in research & development to integrate AI in care delivery. The RFI has a 60-day comment period. Read more in the press release here.

CMS Innovation Center releases RFA for ACCESS Model. The voluntary model was announced December 4, 2025, and aims to test an outcome-aligned payment approach in Original Medicare to expand access to new technology-supported care options that help people improve their health and prevent and manage chronic disease. The RFA states that to be considered for the model’s first performance period beginning July 5, 2026, applications must be submitted by April 1, 2026. Any applications submitted after that will be considered for a January 1, 2027, start. The RFA specifies application and participant requirements, beneficiary eligibility, care delivery requirements, performance measurement, payment design, and other details related to the model and the application. Stakeholders interested in updates about the model can fill out an interest form.

QUICK HITS


  • Bipartisan lawmakers express concern about nursing degree classification. More than 140 bipartisan members of Congress, led by Sens. Merkley (D-OR) and Wicker (R-MS) and Reps. Kiggans (R-VA) and Bonamici (D-OR), sent a letter to the US Department of Education noting their concern with the department’s decision to not classify nursing degrees as professional degrees, thereby reducing the amount of loans available to nursing students. The Department of Education is expected to release a proposed rule on this issue in early January 2026.
  • House Judiciary Committee Republican leaders request information on fraud from insurers. The letters from Committee Chair Jordan (R-OH) and Subcommittee Chairs Fitzgerald (R-WI) and Van Drew (R-NJ) request information from eight large insurers regarding consumer enrollment, agents and brokers, and APTC fraud.
  • President Trump designates fentanyl as weapon of mass destruction. In an EO, President Trump directed the attorney general to pursue criminal charges and enhanced sentences related to fentanyl trafficking and directed the US Departments of State and Treasury to pursue actions against financial institutions involved in or supporting the manufacture, distribution, and sale of illicit fentanyl and its precursor chemicals. Read the fact sheet here.
  • President Trump signs EO on medical marijuana and marijuana research. The EO directs the attorney general to reschedule marijuana as a Schedule III controlled substance and states that the administration will work with Congress to update the definition of hemp-derived cannabinoid (CBD) products to ensure Americans can access full-spectrum CBD products. Read the fact sheet here.
  • HHS adds two rare diseases to newborn screening recommendations. HHS announced the addition of Duchenne muscular dystrophy and metachromatic leukodystrophy to the Recommended Uniform Screening Panel (RUSP) for newborns. The RUSP is a list of disorders that HHS recommends that states include in their universal newborn screening programs.
  • CDC adopts ACIP hepatitis B vaccine recommendation. Following a recommendation by the Advisory Committee on Immunization Practices (ACIP), the Centers for Disease Control and Prevention (CDC) will amend the child immunization schedule to allow parents to decide whether to give the hepatitis B vaccine at birth to infants born to women who have tested negative for the virus. For infants not receiving the dose at birth, the CDC recommends the initial dose be administered no earlier than two months of age.
  • HHS hosts event, announces action on Lyme disease. The event featured Lyme disease patients, providers, and researchers, along with Sen. Collins (R-ME) and Reps. Griffith (R-VA) and Smith (R-NJ). HHS announced the renewal of the LymeX Innovation Accelerator, created in the first Trump administration to improve Lyme disease diagnostics and care, and a $10 million initiative to advance AI tools that support earlier and more accurate detection.
  • FDA releases guidance on drug and device application review process. The guidance states that the FDA will accept real-world evidence without requiring that marketing submissions include identifiable individual patient data collected from real-world data sources. The FDA noted that it will consider making the same update to its guidance for drugs and biologics. Read the press release here.
  • HHS Office of Inspector General issues report on dual-eligibles’ access to drugs. The statutorily mandated report details trends related to dual-eligible individuals’ access to prescription drugs under Medicare Part D, and notes that Part D plan formularies cover 98% of drugs commonly used by dual-eligibles.
  • GAO releases report on FDA medical device recall process. The US Government Accountability Office (GAO) noted that the medical device recall process has inefficiencies due to ongoing FDA challenges, including insufficient staffing. The GAO recommended that HHS consider FDA staffing capacity as the agency undergoes restructuring and assess whether the FDA should have additional legislative authority to require manufacturers to implement agency recommendations for manufacturer-initiated recall strategies.
  • FTC reschedules noncompete agreement workshop. The Federal Trade Commission (FTC) workshop, originally scheduled for October 2025, will be held January 27, 2026. The workshop will include statements from FTC commissioners and experts in the field, and will continue the Trump administration’s efforts to restrict noncompete agreements, particularly in the healthcare sector.
  • Senate confirms HHS inspector general. In a 53 – 43 party line vote, Thomas Bell was confirmed as the next HHS inspector general en bloc with other Trump nominees. Bell replaces Christi Grimm who was removed by President Trump earlier this year.
  • Trump administration announces nine additional MFN agreements. The announcement continues the administration’s priority of lowering consumer drug costs through the most-favored-nation (MFN) drug pricing model and follows previous agreements with prescription drug manufacturers. We await the release of the proposed rules for the CMS Innovation Center’s Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) models, which are expected to include MFN components and could be released as early as the afternoon of December 19, 2025.

NEXT WEEK’S DIAGNOSIS


Congress left town Thursday December 18, 2025, and will continue its holiday recess next week. The healthcare debate will resume when it returns in early January 2026, given the December 31, 2025, expiration of the enhanced APTCs and the pending House vote on the discharge petition. We are also on the lookout for HHS’ announcement of funding for the Rural Health Transformation Program grants before the statutory deadline of December 31, 2025. The Senate returns January 5, 2026, and the House returns January 6, 2026. The Check-Up will be on hiatus until January 9, 2026.