Looking Ahead
The U.S. House of Representatives has passed a bill to extend the enhanced advanced premium tax credits (APTCs) for three years following a 230-196 vote, with 17 Republicans voting with Democrats to support its passage. The vote was set up following a successful discharge petition, but the bill likely faces an uphill battle in the U.S. Senate, as conversations remain ongoing about potential proposals to extend the APTCs with additional changes that will need to garner 60 votes for passage. Following the House’s passages of the bill to extend the APTCs, President Donald Trump signaled over the weekend that he may use his veto authority should the bill get to his desk. In the Senate, one sticking point in negotiations over a different bipartisan agreement is the inclusion of language related to applying Hyde Amendment-like restrictions to APTCs, despite President Trump urging “flexibility” on Hyde Amendment language. The Hyde Amendment prohibits the use of federal funding for abortions, with limited exceptions.
Attention from the U.S. Congress this week will also be on the looming January 30, 2026, funding deadline. The Senate is expected to hold votes on the minibus spending package that passed the House with a significant bipartisan vote on January 8, 2026, which includes the Energy and Water, Interior, and Commerce-Justice-Science spending bills. The House may also consider other minibus packages such as the Financial Services-General Government and State, Foreign Operations, and Related Programs spending bills. Funding for the U.S. Department of Homeland Security (DHS) was initially expected to be included in the package, but it appears to be trending toward being considered separately – potentially as a part of a continuing resolution (CR) following disagreements regarding the funding for DHS, as well as Immigrations and Customs Enforcement (ICE) events in Minnesota. Conversations around the remaining spending bills – including the Labor, Health and Human Services, Education and Related Agencies (LHHS) bill – are ongoing.
Upcoming Events
The House Committee on Veterans’ Affairs Subcommittee on Health held a legislative hearing on January 13, 2026, to consider the following:
- Discussion Draft: BEACON Act
- Blast Overpressure Research and Mitigation Task Force Act (H.R.6444)
- Clarity on Care Options Act (H.R.6526)
- Discussion Draft: Data Driven Suicide Prevention Act
- Recognizing Community Organizations for Veteran Engagement and Recovery (RECOVER) Act (H.R.2283)
- Discussion Draft: Health Desert Reform Act
- Veterans Mental Health and Addiction Therapy Quality of Care Act (H.R.2426)
- U.S. Vets of the Freely Associated States (FAS) Act (H.R.6652)
- NOPAIN for Veterans Act (H.R. 4509)
- To Amend Title 38, U.S. Code, to Direct the Secretary of Veterans Affairs to Furnish an Opioid Antagonist to a Veteran without Requiring a Prescription or Copayment (H.R. 5999)
- Veterans with ALS Reporting Act (H.R.6001)
- Discussion Draft: Whole Health for Veterans Act
The House Veterans’ Affairs Committee will hold a hearing on January 14, 2026, titled “Reevaluating the Rating Schedule: Examining VA’s Efforts to Modernize Disability Benefits.”
The Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing on January 14, 2026, titled “Protecting Women: Exposing the Dangers of Chemical Abortion Drugs.”
The Senate Committee on Commerce, Science and Transportation will hold a hearing on January 15, 2026, titled “Plugged Out: Examining the Impact of Technology on America’s Youth.” The hearing will focus on the use of technology and social media by children and youth.
The Senate HELP Committee will also hold a full committee markup on January 15, 2026, to consider the following:
- Women and Lung Cancer Research and Preventive Services Act of 2025 (S.1157)
- Tyler’s Law (S.921)
- Rural Hospital Cybersecurity Enhancement Act (S.2169)
- Protect Infant Formula from Contamination Act (S.272)
The House Committee on Energy and Commerce, along with the Committee on Ways and Means, will hold hearings on January 22, 2026, regarding how to make healthcare more affordable for Americans. The CEOs of five major health insurance companies are expected to testify.
President Trump will deliver the State of the Union Address before a Joint Session of Congress on February 24, 2026.
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 Updates
- Sara Bailey was confirmed on January 7, 2026, to be director of the Office of National Drug Control Policy (ONDCP) in a 52-48 vote.
Congressional Updates
House Dems Push Legislation to Bar WISeR Model
In a House Committee on Energy and Commerce Subcommittee on Health hearing on January 8, 2026, several democrats, including Reps. Kim Schrier (D-DC), Chris Palone (D-N.J.) and Greg Landsman (D-Ohio), expressed concerns about the use of artificial intelligence (AI) to make claims determinations. The inclusion of the Ban AI Denials in Medicare Act (H.R.6361) in the hearing indicates growing bipartisan hesitation with the Wasteful and Inappropriate Service Reduction (WISeR) Model.
Agreement to Extend APTCs Remains Elusive as January 30 Nears
Despite House passage of a bill to extend the enhanced APTCs for three years, an agreement to renew and extend the subsidies remains elusive and the House and Senate remain far apart. Despite 17 Republicans joining all Democrats to pass the clean three-year subsidy extension bill – a rebuke of Speaker Mike Johnson (R-La.) – the bill is likely to fail in the Senate should it be brought up for a vote. In late 2025, the Senate voted on and failed to meet the 60-vote threshold to pass a bill to extend the APTCs for two years. In addition, a bipartisan group of senators is discussing a healthcare package that could include a short-term extension of APTCs, Health Savings Accounts (HSAs) and zero-dollar premiums. However, these talks may not lead to an agreement – especially without President Trump’s support.
SFC Democrats Send Letter to Major Insurer, Requests Detailed Information on Nursing Home Practices
Senate Committee on Finance (SFC) members Sen. Ron Wyden (D-Ore.) and Elizabeth Warren (D-Mass.) sent a letter to a major insurance company on January 7, 2026, requesting details on nursing home practices. The letter highlights the members’ concerns regarding practices in nursing homes that may endanger the lives and safety of residents and is a follow-on effort to work underway by SFC committee members and staff. The letter requests detailed answers to questions regarding hospitalization practices, hospital transfers, advance directives, marketing practices and federal oversight.
Regulatory Updates
CMS Issues New RFI, Signals Major Medicare Claims Modernization Efforts
The Centers for Medicare & Medicaid Services (CMS) issued a new Request for Information (RFI) seeking input from vendors capable of operating large-scale, real-time claims adjudication systems. Vendors must already support more than 2 million active members on a single production instance and process over 100,000 claims per day, with CMS sizing the full Medicare workload at approximately 34 million beneficiaries and 4.5 million claims per day.
In the RFI, CMS states that it is seeking information on vendors that can support its objectives of improving beneficiary experience, reducing provider burden and increasing administrative efficiency in Original Medicare, and notes that responses may inform future evaluation of claims adjudication systems. The depth and specificity of the technical questions strongly suggest CMS is laying the groundwork for a sweeping modernization of Medicare’s claims payment infrastructure – an idea Administrator Mehmet Oz has been publicly discussing for several months.
U.S. Department of Health and Human Services (HHS) Chief Information Officer Clark Minor will lead the effort. The RFI asks vendors detailed questions across several key areas, including:
- demonstrated scale and performance of real-time claims adjudication platforms
- reference customers meeting CMS’ size and throughput thresholds
- deployment and operating models, including full deployment in CMS-owned cloud infrastructure services
- detailed AWS cost estimates using CMS’ Medicare baseline assumptions
- pricing models for licensing, implementation, operations and customization
- willingness to stand up and operate a proof-of-concept (PoC) in CMS Cloud
- timelines for PoC delivery, full production cutover and legacy system retirement
- experience executing enterprise-scale parallel processing cutovers
- estimated timelines to deploy across a single Medicare Administrative Contractor (MAC) and then all seven MACs (including 200 integrations per MAC)
DOJ to Create New Division to Investigate and Prosecute Fraud
The U.S. Department of Justice (DOJ) will stand up a new division to investigate and prosecute fraud nationally, which may include investigations into large federal healthcare programs such as Medicaid. While a fact sheet released on January 8, 2026, alongside the announcement about the division’s creation does not detail scope, the fact sheet does detail that the Assistant Attorney General for the division will lead all its efforts regarding “fraud affecting the Federal government, Federally funded programs, and private citizens.”
FDA Announces Draft Guidance on Use of Bayesian Methodology in Clinical Trials
The U.S. Food and Drug Administration (FDA) issued draft guidance on January 8 2026, titled “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products” to provide guidance on the use of Bayesian methods in clinical trials for drug and biological products. The Bayesian method or Bayesian statistics is a framework that expresses probability as a certain degree of belief. FDA provides the guidance to address considerations on designing clinical trials using Bayesian approaches. The draft guidance is intended to allow additional flexibility in the design of clinical trials and dosing provided, maximizing the totality of all evidence to inform decisions.
FDA Issues Updated Guidance on General Wellness Products
In a guidance document issued January 6, 2026, FDA iterated that it will consider non-invasive monitoring features as general wellness products. The document specifies that Center for Devices and Radiological Health (CDRH) “does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the [Federal Food, Drug, and Cosmetic Act] FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations.” The guidance announcement was coupled with the release of guidance on clinical decision support software.
FDA Issues Draft Guidance on CDS Software
FDA issued draft guidance on January 6, 2026, titled “Clinical Decision Support Software.” The guidance document supersedes prior guidance issued on September 28, 2022, and outlines a more light-touch approach to the regulation of certain clinical decision support (CDS) software, including AI-enabled products. The guidance document, if or when finalized, would represent a departure from previous FDA guidance and would exempt certain lower-risk CDS software from medical device regulations and only be subject to enforcement discretion. Some software that only offers one treatment option may be exempted from medical device regulations.
Notably, at a major health technology conference, FDA Commissioner Marty Makary announced these changes, as well as indicated several potential actions in the near future, including that the agency is working on a “new regulatory framework for AI.” Makary went on to claim, “If you’re not making medical or clinical claims, you don’t need to come through the FDA and we’ll get out of the way.”
FDA Announces Information About Cell and Gene Therapy CMC Requirements
FDA released additional information on January 11, 2026, about the agency’s approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies.
HHS, USDA Release Dietary Guidelines for Americans 2025-2030
HHS and the U.S. Department of Agriculture (USDA) released the Dietary Guidelines for Americans (DGA) 2025-2030 on January 7, 2026. The DGA is a set of guidelines and recommendations released every five years by HHS and USDA. The recommendations outline recommendations on meeting dietary requirements.
The most recent iteration is streamlined to 10 pages and highlights recommendations related to increased protein intake, higher consumption of dairy and “healthy fats,” as well as an emphasis on whole foods such as fruits and vegetables. The DGA 2025-2030 also emphasizes limitations on processed foods, added sugars, refined carbohydrates and alcoholic beverages in moderation.
HHS Publishes Proposed Update to Master List of Items with Face-to-Face, Prior Authorization Requests
HHS proposed updates on January 12, 2026, to the master list of items potentially subject to face-to-face encounters and requirements for written orders prior to delivery, as well as the potential application of prior authorization requirements. The proposal updates a variety of Healthcare Common Procedure Coding System (HCPCS) codes. The proposed rule will take effect in 90 days. The last update to the Master List was published on May 13, 2024. More information is available online.
MedPAC Seeks Nominations
The U.S. Government Accountability Office (GAO) is currently accepting nominations to the Medicare Payment Advisory Commission (MedPAC). Nominations, if accepted, will be effective in May 2026. Letters of nomination and resumes should be submitted no later than February 6, 2026.
National Institute of Standards and Technology Releases RFI on Security Considerations for AI Agents
The National Institute of Standards and Technology’s (NIST) Center for AI Standards and Innovation (CAISI) released a request for information (RFI) on January 7, 2026, on practices and methodologies for measuring and improving the secure development and deployment of AI systems. Responses are due within 60 days.
Legal Updates
First Circuit Rejects Trump Administration’s Appeal in 340B Rebate Model Case
The U.S. Court of Appeals for the First Circuit – following an appeal of a Maine district court’s ruling that blocked implementation of the 340B Rebate Model Pilot Program – rejected the Trump Administration’s request on January 8, 2026, to allow the 340B Rebate Model Pilot to continue. As a result, HRSA must continue to keep the program on hold while the case is being resolved. In the decision, the circuit court judges concluded that “the federal government has failed to carry its burden of mak[ing] a strong showing that [it is] likely to succeed on the merits” and denied the government’s request for a stay. It is likely the case will be appealed to higher courts. In addition, HRSA will likely assess other avenues to move forward with the changing of rebates from up-front discounts to post-purchase rebates.
