A year after President Trump issued Executive Order (EO) 14273, Lowering Drug Prices by Once Again Putting Americans First, federal agencies continue to take steps to advance its objectives.
Although the EO’s deadlines and goals are not immediately enforceable, they provide insight into the Trump Administration’s drug pricing priorities and the timing of implementation. The Trump Administration has taken steps to complete many of the directives below, though several remain in the rulemaking phase and have yet to be fully implemented.
Some directives ask agency officials to provide recommendations to the President but do not specifically require them to be publicly released. For these actions, work may be ongoing without public visibility.
Building on our August 2025 analysis, the chart below outlines the EO directives, implementation timing, and agency actions to date in the chart below. Applied Policy continues to track implementation efforts and is ready to help stakeholders navigate the implications of each directive.
| EO Directive | EO-Directed Timing | Release Date | Agency Actions |
|---|---|---|---|
| Sec. 3. Improving upon the Inflation Reduction Act Release Medicare Drug Price Negotiation Program Guidance for IPAY 2028 and MFP Effectuation for IPAY 2026–2028 |
June 14, 2025 |
May 12, 2025
September 30, 2025
|
The Draft and Final Medicare Drug Price Negotiation Guidance for IPAY 2028 address negotiation implementation for IPAY 2028 and MFP effectuation for 2026–2028. However, CMS did not address Part B MFP effectuation policy in detail in this guidance.
CMS also maintained its approach to fixed combination products but indicated that changes may be considered for IPAY 2029.
Stakeholders are closely watching to see how CMS will address these issues, potentially in the Medicare Drug Price Negotiation Program proposed rule that is currently pending OMB review.
|
| Sec. 8. Reevaluating the Role of Middlemen Recommendations promoting lower drug prices in the pharmaceutical supply chain |
July 14, 2025 | No recommendations have been publicly released | No recommendations have been publicly released, but the Consolidated Appropriations Act, 2026, includes significant changes to pharmacy benefit manager (PBM) oversight and transparency. |
| Sec. 7. Access to Affordable Life-Saving Medications Access to insulin and injectable epinephrine at or below 340B acquisition cost |
July 14, 2025 | June 24, 2025 | The Health Resources and Services Administration (HRSA) announced actions to lower out-of-pocket costs for insulin and injectable epinephrine for low-income patients receiving these products from HRSA-funded health centers by issuing updated award terms that align with the EO requirements. |
| Sec. 10. Increasing Prescription Drug Importation to Lower Prices Steps to increase importation |
July 14, 2025 | May 21, 2025 |
FDA issued a press release outlining steps to enhance state and tribal importation programs under section 804 of the Federal Food, Drug, and Cosmetic Act.
These include: (1) a pre-review option for draft proposals and informal FDA feedback prior to formally submitting their section 804 importation program (SIP) proposal; (2) development of a user-friendly proposal tool; and (3) additional support for states in conducting required cost savings analyses.
|
| Sec. 3. Improving upon the Inflation Reduction Act Recommendations to stabilize and reduce Medicare Part D premiums |
October 12, 2025 | July 28, 2025 | On July 28, 2025, CMS released the 2026 Medicare Part D Bid Information and Part D Premium Stabilization Demonstration Parameters. The base beneficiary premium for 2026 will be $38.99, a 6% increase from last year’s premium. Under the Inflation Reduction Act (IRA), the annual increase in the base beneficiary premium is not to exceed 6% per year. CMS will also continue with the voluntary Part D Premium Stabilization Demonstration, which began last year to stabilize year-over-year changes in premiums for standalone prescription drug plans (PDPs) as the IRA’s Part D benefit redesign is ongoing. CMS is updating parameters for the demonstration this year by reducing the uniform base beneficiary premium reduction from $15 to $10, increasing the limit on a plan’s total Part D premium increase from $35 to $50, and ending narrowed risk corridor thresholds. |
| Sec. 9. Accelerating Competition for High-Cost Prescription Drugs Recommendations on increasing access to generics, biosimilars, combination products, second-in-class brand name medications, and OTC medications |
October 12, 2025 | No recommendations have been publicly released | No recommendations have been released, but FDA has taken actions to expedite development for generics and biosimilars, including by streamlining biosimilar study requirements and prioritizing review of ANDAs that are domestically manufactured and tested. |
| Sec. 5. Appropriately Accounting for Acquisition Costs of Drugs in Medicare Plan to survey hospital acquisition cost for outpatient drugs |
October 12, 2025 |
OPPS Proposed Rule, released July 16, 2025
OPPS Final Rule, released November 21, 2026
Survey (ongoing, due April 7)
|
In the Calendar Year (CY) 2026 Outpatient Prospective Payment System (OPPS) Final Rule, CMS finalized its intent to conduct a survey to inform CY 2027 payment policy.
The survey follows the June 2022 Supreme Court decision in American Hospital Association v. Becerra, which held that HHS may not vary payment rates for drugs and biologicals among hospital groups without first conducting an acquisition cost survey.
The survey is ongoing, with responses due April 7.
This survey is responsive to the Supreme Court decision and may lead to lower Medicare hospital outpatient payment for 340B-acquired drugs.
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| Sec. 12. Improving Transparency into PBM Fee Disclosure Propose ERISA-related fiduciary transparency regulations |
October 12, 2025 | January 29, 2026 |
On January 29, 2026, the Department of Labor’s Employee Benefits Security Administration proposed the Improving Transparency into Pharmacy Benefit Manager Fee Disclosure Rule. Comments are due April 15, 2026.
This rule would require PBMs to disclose compensation to self-insured group health plans. Specifically, PBMs would be required to disclose:
DOL also proposes to allow plan fiduciaries to audit PBM disclosures for accuracy at least once per year and outlines what plan fiduciaries may do if their PBMs do not meet the required disclosures.
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| Sec. 11. Reducing Costly Care for Seniors Site-neutral payment for drug administration |
October 12, 2025 | November 21, 2025 | In the CY 2026 OPPS Final Rule, CMS finalized policies to align payment rates for drug administration in off-campus provider-based departments with those in the physician office setting, a step toward site neutrality. CMS also sought feedback on potentially expanding site neutrality in the proposed rule. See Applied Policy’s summary of the OPPS Final Rule for more details. |
| Sec. 6. Promoting Innovation, Value, and Enhanced Oversight in Medicaid Drug Payment Recommendations on Medicaid drug pricing reform |
October 12, 2025 | No recommendations have been publicly released | CMS has released the voluntary GENEROUS Model, and MFN agreements include MFN pricing for drugs in Medicaid. However, no report on recommendations on Medicaid drug pricing reform has been released. |
| Sec. 13. Combating Anti-Competitive Behavior by Prescription Drug Manufacturers Listening sessions and report |
October 12, 2025 | Listening sessions were held June 30, July 24, and August 4; report has not been released. |
The FTC held three listening sessions addressing anticompetitive conduct, formulary and benefit design practices, and policy approaches to reduce drug prices.
These sessions will inform a forthcoming report on manufacturer behavior. The report has not yet been released.
The listening sessions will inform the report on combating anti-competitive manufacturer behavior.
|
| Sec. 4. Reducing the Prices of High-Cost Drugs for Seniors Rulemaking for a CMMI drug pricing model |
April 15, 2026 | December 19, 2025 |
On December 19, 2025, CMS released the Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545-P) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546-P) Proposed Rules. Both proposed models would operate similarly to the current Medicare inflation rebates program, where manufacturers of eligible drugs pay rebates directly to CMS when they raise their prices above a benchmark.
For these models, the benchmark used to calculate the rebate would be based on international pricing information, rather than domestic pricing information. Comments were due on February 23, 2026.
The Trump Administration has also pursued Most Favored Nation pricing via an Executive Order that directs pharmaceutical manufacturers to voluntarily align their prices with those paid internationally. The President sent letters to seventeen drug manufacturers, directing further actions related to MFN policy implementation.
Sixteen of seventeen manufacturers have entered into agreements with the Trump Administration, with limited details available in companies’ SEC filings, per STAT News. Comments on the GLOBE and GUARD Models from manufacturers with agreements also raise questions about whether manufacturers with agreements are exempt from these models.
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| Sec. 3. Improving upon the Inflation Reduction Act Addressing “pill penalty” |
— | — | Addressing the Inflation Reduction Act’s “pill penalty,” in which small molecule drugs are eligible for negotiation earlier than biologics, requires Congressional action. |
