![]() ![]() Beyond those specific 340B eligible patients, it is unclear how this executive order will have a broader impact on drug pricing. Not only is its scope limited to two drugs, but the executive order also addresses the dispensing of those drugs only by 340B FQHCs, and only to certain 340B eligible patients of the FQHC Covered Entities. ![]() The limited nature of this executive order raises questions as to whether it will have any broad meaningful impact on drug pricing. The executive order, although benefiting FQHC patients eligible to receive the discount, would be the first instance where FQHCs or any other 340B Covered Entity would be required to pass on the 340B discounted price to the patient rather than giving the Covered Entity the discretion to reinvest the savings generated from the 340B discounted price into other activities that may benefit the FQHC’s patient population. Similarly, the FQHC federal grant requirements merely require FQHCs to use 340B Program savings for purposes that generally advance the FQHC’s HRSA-federal grant-approved scope of project. The 340B Program generally allows 340B Covered Entities, including FQHCs, to utilize the cost savings from 340B discounted drugs to stretch scarce resources without specific limitations on how the 340B savings are to be used by these Covered Entities. The first executive order directs the Secretary of HHS to require Federally Qualified Health Centers (“FQHCs”) to make insulin and injectable epinephrine available to certain low-income individuals at the price paid by the FQHC under the 340B Prescription Drug Program (“340B Program”). FQHCs-community-based health providers that provide primary care services in underserved areas and meet specific requirements-are funded through federal grant money from HHS’s Health Resources and Services Administration (“HRSA”). To participate in Medicaid, manufacturers must agree to comply with the 340B Program’s requirement to sell certain outpatient drugs at statutorily determined discounted prices to statutorily defined “Covered Entities,” such as FQHCs, that provide care to low-income and uninsured patients. Under this executive order, the Secretary would condition an FQHC’s future operating FQHC federal grants upon having the FQHC make insulin and injectable epinephrine available at the 340B discounted price it paid-plus a minimal administration fee-to certain low-income patients who have a high cost-sharing requirement for either insulin or injectable epinephrine, a high unmet deductible, or no health insurance. According to President Trump, this executive order would cause FQHCs to pass along “the giant discounts they receive from drug companies on insulin and EpiPens directly to their patients.” 340B Discounts for Insulin and Injectable Epinephrine Department of Health & Human Services (“HHS”), to implement the four policies through federal rulemaking procedures however, these executive orders do not address some of the underlying barriers that hindered progress on similar proposals. The executive orders direct Alex Azar, the Secretary of the U.S. ![]() The orders were designed to reduce insulin and injectable epinephrine out-of-pocket expenses for certain individuals, permit drug importation from Canada or through individual waivers, limit prescription drug rebates, and recommence efforts to use external benchmarking to set prices of certain drugs at the level paid by other countries. These executive orders largely attempt to resurrect drug pricing reform initiatives originally mentioned in the Trump administration’s 2018 “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”Īlthough these executive orders could be viewed as far-reaching proposals that may attract attention during this presidential election year, they have no immediate legal effect. On July 24, 2020, President Trump signed four executive orders of sweeping breadth that address prescription drug prices. This “Buy American” executive order is the latest in a series of recent executive orders aimed at tackling issues within the pharmaceutical industry. On August 6, 2020, President Donald Trump signed an executive order directing federal agencies to increase domestic procurement and identify supply chain vulnerabilities of certain essential medicine and products. ![]()
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