Apr 16, 2025
Executive Order Signed – Lowering Drug Prices
Yesterday, on April 15, 2025, the President signed another Executive Order in an effort to work towards lowering prescription drug prices.
Below are summarized Sections of the Executive Order.
Improving upon the Inflation Reduction Act. Within 60 days of the date of this order, the Secretary of Health and Human Services, shall propose and seek comment on guidance for the Medicare Drug Price Negotiation Program for initial price applicability year 2028 and manufacturer effectuation of maximum fair price under such program in 2026, 2027, and 2028.
Reducing the Prices of High-Cost Drugs for Seniors. Within 1 year of the date of this order, the Secretary shall take appropriate steps to develop and implement a rulemaking plan and select for testing, a payment model to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biological products.
Appropriately Accounting for Acquisition Costs of Drugs in Medicare. Within 180 days of the date of this order, the Secretary shall publish in the Federal Register a plan to conduct a survey of the Social Security Act to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments.
Promoting Innovation, Value, and Enhanced Oversight in Medicaid Drug Payment. Within 180 days of the date of this order, different agencies shall jointly provide recommendations on how best to
- ensure that manufacturers pay accurate Medicaid drug rebates,
- promote innovation in Medicaid drug payment methodologies,
- link payments for drugs to the value obtained, and d) support States in managing drug spending.
Access to Affordable Life-Saving Medications. Within 90 days of the date of this order, the Secretary shall take action to ensure future grants are conditioned upon health centers establishing practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee or sub-grantee.
Reevaluating the Role of Middlemen. Within 90 days of the date of this order, the Assistant to the President for Domestic Policy, shall provide recommendations on how best to promote a more competitive, efficient, transparent, and resilient pharmaceutical value chain that delivers lower drug prices for Americans.
Accelerating Competition for High-Cost Prescription Drugs. Within 180 days of the date of this order, the Secretary, through the Commissioner of Food and Drugs, shall issue a report providing recommendations to:
- accelerate approval of generics, biosimilars, combination products, and second-in-class brand name medications; and
- improve the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter.
Increasing Prescription Drug Importation to Lower Prices. Within 90 days of the date of this order, the Secretary shall take steps to streamline and improve the Importation Program of the Federal Food, Drug, and Cosmetic Act.
Reducing Costly Care for Seniors. Within 180 days of the date of this order, the Secretary shall evaluate and propose regulations to ensure that payment within the Medicare program is not encouraging a shift in drug administration volume away from less costly physician office settings to more expensive hospital outpatient departments.
Improving Transparency into Pharmacy Benefit Manager Fee Disclosure. Within 180 days of the date of this order, the Secretary of Labor shall propose regulations to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers.
Combating Anti-Competitive Behavior by Prescription Drug Manufacturers. Within 180 days of the date of this order, the Secretary or his designee shall issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.
More detailed information is available in the actual Executive Order.
While every effort has been taken in compiling this information to ensure that its contents are totally accurate, neither the publisher nor the author can accept liability for any inaccuracies or changed circumstances of any information herein or for the consequences of any reliance placed upon it. This publication is distributed on the understanding that the publisher is not engaged in rendering legal, accounting, or other professional advice or services. Readers should always seek professional advice before entering into any commitments.
