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Administration Announces Health Plan, Finalizes Drug Importation, and Takes Action on Insulin and Injectable Epinephrine

Breaking News

September 25, 2020

President Trump announced his America First Healthcare Plan (the “Plan”), which was laid out in an executive order (EO). The Plan broadly focuses on three areas: patient choice, healthcare costs, and care quality. Rather than setting forth a number of new initiatives or directives, the Plan ties together a number of previous EOs and directs the Department of Health and Human Services (HHS) secretary to take additional actions to implement those EOs.

Based on the press conference and a preliminary review of the Plan, it includes:

  • Patient Choice: Under the Plan, Americans will have the ability to shop for insurance with the employer covering the cost. Additionally, HHS will continue to expand and enhance telehealth services and accessibility, making permanent some flexibilities provided during the pandemic.

  • Healthcare Costs: The EO directs the HHS secretary to find a legislative or regulatory solution to end surprise billing. The EO also directs HHS to further implement a previous EO on hospital price transparency, and directs the HHS secretary to begin determining compliance with new hospital price transparency requirements by Jan. 1, 2021. The EO also addresses actions on drug pricing and directs agency work to continue on the previous EO regarding tying American drug prices to prices in comparable foreign countries. Further, the EO directs additional work on drug importation and insulin prices, which were the subject of separate administration action on Sept. 24:


  • Importation: The Food and Drug Administration (FDA) published a final rule and final guidance implementing its Safe Importation Action Plan. The final rule allows programs approved by FDA to import certain drugs from Canada, provided a number of conditions are met. In particular, the importation program must be able to demonstrate that importation poses no additional risk to the public’s health and safety while achieving a significant reduction in cost. The final guidance is focused on drug manufacturers, and sets out a process for the importation of drugs and biologics that are “FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.” On initial review, the final rule and guidance track closely to the original Safe Importation Action Plan, but deeper analysis is ongoing. ASHP continues to oppose importation of drugs (other than for personal use) and will provide members with an issue brief detailing the final rule and guidance in the coming days.

  • Insulin/Injectable Epinephrine and 340B: The Health Resources and Services Administration released a proposed rule implementing the president’s EO on insulin and injectable epinephrine. The proposed rule provides detail on the practices that federally qualified health centers (FQHCs) must establish to provide access to insulin and injectable epinephrine to low-income patients at the price that the FQHC purchased these two drugs through the 340 Drug Pricing Program. Given recent manufacturer attacks on the 340B program, ASHP remains extremely concerned about any changes to the program and will submit comments on the proposed rule

During the press conference, the president also announced that the administration will send a one-time $200 discount card to Medicare beneficiaries. The discount card was not included in the EO, so there are no immediately available details regarding how the cards will be funded or how they will be distributed.

  • Care Quality: The EO directs the HHS secretary to “build upon existing actions to improve quality in the delivery of care for veterans." It also directs HHS to continue “to promote medical innovations to find novel and improved treatments for COVID-19, Alzheimer’s disease, sickle cell disease, pediatric cancer, and other conditions threatening the well-being of Americans.”

ASHP will provide members with updates regarding HHS actions and other efforts to implement elements of the Plan.