This order makes it the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at a lower cost to American patients and taxpayers.
The order directs: (a) the Secretary of Health and Human Services (“Secretary”) to propose and seek comment on guidance for the Medicare Durg Price Negotiation Program within 60 days of the order; (b) the Assistant to the President for Domestic Policy, in coordination with the Secretary, the Director of the Office of Management and Budget (OMB Director), and the Assistant to the President for Economic Policy to provide recommendations to the President on how best to stabilize and reduce Medicare Part D premiums within 180 days of the order; and (c) the Secretary to work with Congress to modify the Medicare Durg Price Negotiation Program.
The order also contains the following directions and deadlines:
- Within one year of the order, the Secretary shall take steps to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biological products covered by Medicare.
- Within 180 days of the order, the Secretary shall publish a plan to conduct a survey to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments. Upon the survey’s conclusion, the Secretary shall propose adjustments that would align Medicare payment with the cost of acquisition.
- Within 180 days of the order, the OMB Director, the Assistant to the President for Domestic Policy, and the Assistant to the President for Economic Policy shall work with the Secretary to recommend to the President 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 support States in managing drug spending.
- Within 90 days of the order, the Secretary shall take action to ensure future grants under section 330(e) of the Public Health Service Act, as amended, 42 U.S.C. 254b(e), 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 under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes.
- Within 90 days of the order, the Assistant to the President for Domestic Policy, in coordination with the Secretary, the OMB Director, and the Assistant to the President for Economic Policy, shall provide recommendations to the President on how best to promote a more competitive and transparent pharmaceutical value chain that delivers lower drug prices for Americans.
- Within 180 days of the order, the Secretary, through the Commissioner of Food and Drugs, shall issue a report providing administrative and legislative recommendations to: (a) accelerate approval of generics, biosimilars, combination products, and second-in-class brand name medications; and (b) 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.
- Within 90 days of the date of this order, the Secretary, through the Commissioner of Food and Drugs, shall take steps to streamline and improve the Importation Program under section 804 of the Federal Food, Drug, and Cosmetic Act to make it easier for States to obtain approval without sacrificing safety or quality.
Within 180 days of the 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. - Within 180 days of the order, the Secretary of Labor shall propose regulations pursuant to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers.
Within 180 days of the order, the Secretary or his designee shall conduct joint public listening sessions with the appropriate personnel from the Department of Justice, the Department of Commerce, and the Federal Trade Commission and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.
Additional Documentation
- Trump Executive Order - Lowering Drug Prices by Once Again Putting Americans First
