Summary
As Affordable Care Act (ACA) marketplace open enrollment begins and Supplemental Nutrition Assistance Program (SNAP) funding lapsed, bipartisan talks are underway on the fiscal year (FY) 2026 appropriations bills, in hopes that an agreement on funding will lead to a reopening of the government. However, President Trump remains adamant that no health care “fix” will be pursued until the Democrats agree to reopen the government, and has urged Republicans to “terminate the filibuster.” It is the hope that the government will reopen this later week, but the fate of the enhanced premium tax credits and a broader health care package once reopen still remains unclear.
340B Rebate Model Pilot Program
The Health Resources and Services Administration (HRSA) announced that it has approved eight plans for participation in the 340B Rebate Model Pilot Program, beginning January 1, 2026. For 2026, the model is limited to Medicare Drug Price Negotiations Program selected drugs, and the manufacturers of eight of the ten selected drugs will participate.
Under the program, HRSA detailed that covered entities will continue to make purchases through their 340B wholesaler account and ensure they are only requesting rebates on the pilot program drugs dispensed to 340B eligible patients after a purchase is made. Manufacturers will then work with their distributor partners to:
- Ensure the wholesale acquisition cost (WAC) price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate; and
- Obtain necessary data from the 340B wholesaler account to monitor purchases in that account.
Additionally, HRSA explains that it will provide a mechanism for 340B Program stakeholders to provide feedback on their experience utilizing the rebate model. The pilot program page also has frequently asked questions (FAQs) section that address various details of the program, including how rebates are calculated, compliance tracking, and reconciliation of claims.
MAHA Update
Last week, the Food and Drug Administration (FDA) announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children, pursuant to the Make Our Children Health Again Strategy. This includes sending notices to four companies outlining the FDA’s intention to take enforcement action against companies marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay. The agency has also published a scientific evaluation of the current use of unapproved ingestible fluoride drug products and their potential benefits and risks.
Regulatory Update
The Office of Management and Budget (OMB) completed reviewing the following:
- Medicaid and Immigration Status. A final rule titled, “Medicaid Eligibility Changes Under the Affordable Care Act of 2010; Giving States Freedom to Use Immigration Information to Determine State Residency for Medicaid Eligibility.” The final rule is part of the Trump administration’s efforts to increase federal oversight on states using Federal Medicaid funding for the health care of undocumented immigrants.
OMB is also reviewing the following:
- Medicare:
- CY 2027 Medicare Advantage/Part D Policy. Proposed CY 2027 policy and technical changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and PACE
- Medicare Payment Rules. The CY 2026 Hospital Outpatient PPS final rule, the CY 2026 ESRD final rule, and the CY 2026 Home Health PPS final rule.
- Procurement of Domestic PPE. An advance notice of proposed rulemaking that would detail program incentives and requirements for Medicare providers and suppliers to invest and phase-in the procurement of American made personal protective equipment (PPE) and essential medicine to secure our nation’s health and safety.
- Medicaid:
- Gender-Affirming Care.
- A proposed rule titled, “Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth.”
- A proposed rule titled, “Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children.”
- State Directed Payments. A proposed rule titled, “Medicaid Managed Care-State Directed Payments.” The proposed rule appears intended to advance a presidential memorandum released on June 6, which directs HHS to “eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.”
- Gender-Affirming Care.
- Prescription Drugs:
- A proposed rule titled, “Improving Transparency into Pharmacy Benefit Manager Fee Disclosure” and a proposed rule addressing Transparency in Coverage requirements.
- CMMI Drug Pricing Models. A proposed rule for a Global Benchmark for Efficient Drug Pricing (GLOBE) Model and a proposed rule for Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model
- Nutrition:
- Head Start. A notice from the Administration for Children and Families titled, “Publish Request for Information: Nutrition Services in Head Start Programs
- Immigration:
- Unaccompanied Children. An interim final rule titled, “Unaccompanied Children Program Foundational Rule; Update to Include Proof of Identity and Income Verification Standards.”