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Congressional:
House Passes Three-Year ACA Enhanced Premium Tax Credit Extension
On Thursday, the House passed H.R.1834, the Breaking the Gridlock Act, in a 230-196 vote, with 17 Republicans voting alongside all Democrats. The legislation would extend the Affordable Care Act (ACA) enhanced premium tax credits (EPTCs) for three years. The vote followed a procedural step on Wednesday, where the House voted 221-205 on H.Res.780, which provided for consideration of the Breaking the Gridlock Act. Nine Republicans joined Democrats in voting "yes" to discharge the rule from committee, including four Republicans who signed on to the Democratic-led discharge petition to meet the 218-signature threshold for forcing a vote.
In the Senate, a bipartisan group of senators continues to negotiate a deal that would include a two-year EPTC extension and reforms proposed last year by Senators Susan Collins (R-ME) and Bernie Moreno (R-OH), who are leading the talks. Both Collins and Moreno stated they were getting closer to reaching an agreement on a bipartisan Senate health-care deal, with Moreno adding that senators have been discussing extending open enrollment through March 1 as part of the agreement. Reportedly, that compromise bill would extend EPTCs for two years, with reforms that include new income limitations and cost-sharing requirements. The biggest challenge to reaching a bipartisan compromise remains how to deal with the issue of abortion coverage.
House Energy and Commerce Health Subcommittee Holds Hearing on Patient Access to Medicare Services
On Thursday, the House Energy and Commerce Health Subcommittee held a hearing on modernizing and strengthening the Medicare program to sustain and enhance seniors’ access to care. The hearing examined several Medicare payment policies, including legislation to reform the Medicare clinical laboratory fee schedule (CLFS), Medicare’s payment for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), and Medicare’s home infusion therapy benefit, among other policies. Witnesses included Susan Van Meter, President of the American Clinical Laboratory Association; Connie Sullivan, President and CEO of the National Home Infusion Association; Thomas Ryan, President and CEO of the American Association for Homecare; and David Lipschutz, Attorney and Co-Director of Law and Policy at the Center for Medicare Advocacy. See the legislation and witness testimonies here.
House Energy & Commerce and Ways and Means Committees Invite Health CEOs to Hearings
On Thursday, Representative Brett Guthrie (R-KY), Chairman of the House Committee on Energy and Commerce, and Representative Jason Smith (R-MO), Chairman of the House Committee on Ways and Means, announced the details for two upcoming hearings inviting in five of the biggest health insurance company Chief Executive Officers (CEOs) from UnitedHealthcare, CVS Health, Cigna Healthcare, Elevance Health, and Blue Shield of California to answer questions on making health care more affordable for those with commercial insurance coverage. Guthrie and Smith stated, “This hearing is the first in a series to examine the root causes driving higher health care prices and discuss policies that will lower the cost of care for all Americans.” The first two hearings will take place on January 22, 2026. Read the press release here.
Executive Branch:
Trump Administration Resets U.S. Nutrition Policy
On Wednesday, the Trump administration released the 2025-2030 Dietary Guidelines for Americans. The Agriculture and Health and Human Services (HHS) departments recommended for the first time that Americans avoid highly processed foods and refined carbohydrates. The guidelines, known as DGA, also encourage eating "high-quality, nutrient-dense protein foods" at every meal and seek to end what a USDA fact sheet called the "war on healthy fats." The administration unveiled the new guidance at a joint White House briefing with HHS Secretary Robert F. Kennedy Jr., Agriculture Secretary Brooke Rollins, Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz, and other administration officials. "Today, our government declares war on added sugar. Highly processed foods -- loaded with additives, added sugar, and excess salt -- damage health and should be avoided," Kennedy said. Read the dietary guidelines here and the HHS fact sheet here.
FDA Publishes Guidance on Wearables, Clinical Decision-Making Technology
On Tuesday, the Food and Drug Administration (FDA) published a pair of guidance documents outlining how the agency will regulate two types of artificial intelligence-assisted technologies: clinical decision support systems used by physicians to help treat patients and wearable devices used to track health data. The guidance for clinical decision support outlines how the FDA classifies clinical decision software and how developers can ensure that physicians do not rely solely on technology to make diagnoses and treatments. The guidance on wearable technology outlines how developers should assess product risk and the differences between medical and nonmedical wearable devices. FDA Commissioner Marty Makary stated in a video posted on X that the new guidances will promote AI innovation in medical devices and that the FDA needs to "get out of the way" as a regulatory agency for clinical decision-support technology, making it easier for doctors to use the systems in their practices. "We have a clear lane for medical-grade products, but otherwise we need to adapt with the times and be proactive with guidance so that companies and developers are not left confused about what they should be doing or what the FDA wants," he added. Read the guidance for clinical decision support software here and the guidance for wearables here.
CDC Updates Childhood Immunization Schedule
On Monday, Deputy Secretary of Health and Human Services Jim O’Neill, in his role as Acting Director of the Centers for Disease Control and Prevention (CDC), signed a decision memorandum, accepting recommendations from an assessment of U.S. childhood immunization practices, following a directive from President Trump to review international best practices from peer-developed countries. The CDC will continue to recommend that all children are immunized against 10 diseases for which there is international consensus, as well as varicella (chickenpox). For other diseases, the CDC will recommend immunization for high-risk groups and populations, or through “shared clinical decision making.” The updated schedule differs from the CDC child and adolescent schedule at the end of 2024, which recommended 17 immunizations for all children. All immunizations recommended by the CDC as of December 31, 2025, are required to be covered by Affordable Care Act insurance plans and federal insurance programs, including Medicaid, the Children’s Health Insurance Program, and the Vaccines for Children program. Read the press release here and the updated immunization schedule here.
HHS & DEA Extend Telemedicine Flexibilities for Prescribing Controlled Medications Through 2026
On Friday, January 2, the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) announced a fourth temporary extension of telemedicine flexibilities that allow patients to receive prescriptions for controlled medications without a prior in-person visit. The extension runs from January 1, 2026, through December 31, 2026. Read the press release here.
CMS Announces Updates to the Child and Adult Core Health Care Quality Measurement Sets and Mandatory Reporting Guidance
On Tuesday, December 30, the Centers for Medicare & Medicaid Services (CMS) released its annual letter to state health officials, offering guidance to Medicaid programs on the types of reporting data they will be required to disclose to the agency for the following year. The notice states CMS will withdraw immunization reporting requirements for children, adolescents, and pregnant women, citing concern that current quality measures do not capture information on vaccine safety and side effects. CMS explained that states can still voluntarily report immunization records so the agency can maintain long-term data on vaccination status while it works on alternative reporting measures. State Medicaid programs will continue to have the discretion to use vaccine quality measures to set payment agreements with their third-party insurance partner. Read the letter here.
CMS Announces Establishment of the Office of Rural Health Transformation
On Monday, December 29, the Centers for Medicare & Medicaid Services (CMS) announced the establishment of the Office of Rural Health Transformation (ORHT) within the Center for Medicaid and CHIP Services (CMCS). The office will continue overseeing the Rural Health Transformation (RHT) Program. ORHT announced approved awardees on December 29, 2025, and will guide states in implementing their rural health transformation plans, provide technical assistance, coordinate federal and state partnerships, and ensure oversight and accountability throughout the five-year program, which will run through September 30, 2031. Read the press release here and the list of awardees here.
CMS Launches Voluntary Model to Expand Access to Medicines, Promote Healthier Living
On Tuesday, December 23, the Centers for Medicare & Medicaid Services (CMS) announced the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model, designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement. The voluntary model would allow CMS to negotiate directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms. The negotiation areas include guaranteed net pricing and potential out-of-pocket limits for beneficiaries, standardized coverage criteria, and evidence-based lifestyle support offerings. Read the press release here.
CMS Proposes New Mandatory GLOBE Model
On Sunday, December 21, the Centers for Medicare & Medicaid Services (CMS) announced the proposed Global Benchmark for Efficient Drug Pricing (GLOBE) Model. The Model would test a new rebate formula for certain separately payable Medicare Part B drugs, typically administered by physicians in health care settings. The intent of the proposed GLOBE Model is to test an innovative payment model that modifies the Medicare Part B drug inflation rebate calculation for GLOBE Model drugs using international drug pricing information to identify a benchmark that reflects prices paid in a set of economically comparable countries, which CMS expects would reduce program expenditures for Medicare Part B while preserving or enhancing beneficiaries’ quality of care. Read the press release here.
CMS Proposes New Mandatory GUARD Model
On Sunday, December 21, the Centers for Medicare & Medicaid Services (CMS) announced the proposed Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model. The model would test a new rebate formula for Medicare Part D drugs, covering outpatient prescription drugs typically dispensed at retail, mail-order, home infusion, and long-term care pharmacies. The GUARD Model would factor in existing Medicare Part D manufacturer rebates and discounts, and CMS would leverage its authority to test a change in the calculation of Medicare Part D inflation rebates that accounts for the cost of certain drugs in economically similar countries. The model would begin on Jan. 1, 2027, and operate for five years, with rebate invoicing and payments continuing until 2033. The model would encompass 25% of Part D enrollees and apply only to beneficiaries living in randomly selected geographic areas of the country. Read the press release here.
Legal & Other:
Judge Issues Preliminary Injunction for Health Resources and Services Administration 340B Pilot
On Monday, December 29, Judge Lance E. Walker of the US District Court for the District of Maine ruled that hospital groups suing the US Department of Health and Human Services over its new 340B Rebate Model Pilot Program demonstrated they would suffer irreparable harm in order for the court to grant a preliminary injunction, temporarily blocking the plan from going into effect on January 1, 2026. Walker wrote that, “Although the HRSA is empowered by statute to achieve the de-duplication objective through a rebate model, and although it applies to only a subset of drugs sold to 340B covered entities, it marks a departure from the Agency’s decades-long practice of requiring upfront discounts on 340B eligible drugs, and the Agency’s roll out has involved a rather threadbare administrative record that likely fails to consider and reasonably explain the impact of a rebate model on 340B hospitals, who rely on upfront price concessions to stretch few resources as far as possible to serve rural and poor communities.” The government quickly appealed to the U.S. Court of Appeals for the First Circuit. The case is American Hospital Association v. Robert F. Kennedy Jr. Read the court’s order here.
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