- Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen
- The Fourth Executive Order, relating to “Most Favored Nations” pricing for Medicare Part B treatments is set to take effect on August 24, 2020 unless industry and the administration agree to an alternate plan.
Taking a look at each action
- The first Order directs federally qualified health centers (primarily 340B Health Centers) to pass along discounts on insulin and epinephrine received from drug companies to certain low-income Americans.
- The second Order will allow states to create plans for safe importation of certain drugs, authorize the re-importation of insulin products made in the United States, and create a pathway for widespread use of personal importation waivers at authorized pharmacies in the United States.
- The third Order addresses the rebates provided by drug manufacturers to pharmacy benefit managers (PBMs) with a goal of ensuring patients directly benefit from available discounts at the pharmacy counter.
- The fourth and final Order was not released. The administration’s goal is to ensure that the United States pays the lowest price available in economically comparable countries for Medicare Part B drugs. According to President Trump, absent successful negotiations with drug company executives this Order will be implemented on August 24.
Executive orders are actually the beginning of the process that begins the rule making and regulatory process which can be quite lengthy. In addition, it is highly likely that legal action by various parties across the healthcare value chain could slow or shape this process.
Industry has raised significant concerns relative to these Presidential Actions:
Recognizing the severe threat the Trump administration’s executive order adopting foreign price controls pose to innovative biopharmaceutical companies, including those on the frontlines in the effort to eradicate COVID-19, Dr. McMurry-Heath wrote to President Trump urging him to abandon any further implementation of the misguided executive order adopted foreign price controls. To read Dr. McMurry-Heath’s letter to the president, click here.
Pharmaceutical Research and Manufacturers of America President and CEO Stephen J. Ubl made the following statement:
“In his 2020 State of the Union Address, President Trump declared that ‘we will never let socialism destroy American health care.’
“Yet, in the middle of a global pandemic, when nearly 145,000 Americans have lost their lives and millions of others have suffered untold economic hardships, this administration has decided to pursue a radical and dangerous policy to set prices based on rates paid in countries that he has labeled as socialist, which will harm patients today and into the future.
“The research-based biopharmaceutical industry has been working around the clock to develop therapeutics and vaccines to treat and prevent COVID-19. The administration’s proposal today is a reckless distraction that impedes our ability to respond to the current pandemic – and those we could face in the future. It jeopardizes American leadership that rewards risk-taking and innovation and threatens the hope of patients who need better treatments and cures.
“The president’s attempt to open our country up to socialized health care sets America, our economic recovery and scientific progress back at a time when we need them most.” (Source)