July 24, 2020
On July 24, President Donald Trump issued three Executive Orders tasking the Department of Health and Human Services (HHS) with specific steps to support the Administration’s efforts to promote prescription drug importation, make prescription drug discounts/rebates available to consumers, and ensure the accessibility and affordability of critical drugs like insulin and injectable epinephrine. Specifically, the Executive Orders require HHS to:
- Facilitate the importation of prescription drugs by:
- Completing the agency’s ongoing rulemaking process to allow states to import certain prescription drugs from Canada,
- Authorizing the reimportation of insulin products, and
- Creating a pathway for widespread use of personal importation waivers under existing law.
- Finalize the February 2019 proposed rule to revise the anti-kickback statute’s discount safe harbors, which seeks to:
- Exclude from safe harbor protections certain retrospective reductions in price that are not applied at the point-of-sale (or other discounts that drug manufacturers provide to plan sponsors, pharmacies, or pharmacy benefit managers (PBM) in operating the Medicare Part D program); and
- Establish new safe harbors that permit plan sponsors, pharmacies, and PBMs to apply discounts at the patient’s point-of-sale to lower their out-of-pocket costs.
- Take steps necessary to ensure that, to be eligible for operating grants, federally qualified health centers (FQHC) must have established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC under the 340B Prescription Drug Program to certain low-income individuals (i.e., those who have a high cost-sharing requirement for insulin or injectable epinephrine, have a high unmet deductible, or have no health insurance).
President Trump announced a fourth Executive Order, though it is not yet available. According to the Administration’s press materials, the Order would require HHS to ensure that Medicare participants “pay no more for the most costly Medicare Part B drugs than any economically comparable OECD country.” Absent successful negotiations with drug manufacturers—which President Trump plans to kick off in a meeting with drug company executives on July 28—the Administration will implement this Order on August 24, 2020.
The other Orders, however, do not have effective dates or otherwise set strict timelines for action by HHS. Moreover, the question of whether HHS has the statutory authority to implement the rules contemplated by the Executive Orders may further hinder finalization of those rules. As such, it remains to be seen when HHS will begin acting on these Orders and what effect they will ultimately have.
For more information, see the Administration’s Fact Sheet.