HIV/AIDS clinics urged a federal district court in Washington yesterday to grant a temporary restraining order and preliminary injunction to prevent the evisceration of the 340B program “for thousands of safety-net providers and their patients.” | Source: Cempa Community Care website
RWC-340B Seeks Quick Judicial Relief from 340B Contract Pharmacy Rollbacks
Ryan White Clinics for 340B Access (RWC-340B) late yesterday asked a federal district court to issue a temporary restraining order and preliminary injunction requiring U.S. Health and Human Services (HHS) Secretary Alex Azar to issue 340B program binding administrative dispute resolution (ADR) regulations within 60 days, requiring Azar to declare that federal law entitles covered entities to buy covered outpatient drugs at 340B discounts, and ordering Azar to enforce covered entities’ rights to 340B discounts for contract pharmacy orders.
RWC-340B asked for the order and injunction as part of its lawsuit to compel HHS to punish four drug manufacturers—Eli Lilly and Co., AstraZeneca, Sanofi, and Novartis—that are denying 340B pricing on their products when ordered through contract pharmacy arrangements. In a memo RWC-340B filed with its motions for relief, the group said 340B covered entities and the patients they serve will suffer irreparable harm if the court waits until the end of the case to issue remedial orders.
“The drug companies at issue have taken an extreme position that, if unaddressed by the Secretary, will eviscerate the federal 340B drug discount program for thousands of safety-net providers and their patients,” it said.
RWC-340B’s Nov. 23 legal filing was one of three major related developments since Friday. As we reported earlier today, late on Nov. 20, Lilly and Sanofi filed separate motions asking to be named defendants in RWC-340B’s lawsuit against HHS. Also on Nov. 20, United Therapeutics announced that, like Sanofi, it too will begin denying 340B pricing on drugs dispensed by contract pharmacies if covered entities decline to turn over their contract pharmacy claims data.
Two Ryan White CARE Act grantees—Matthew 25 AIDS Services of Kentucky and Indiana, and Cempa Community Care of Tennessee—were the original plaintiffs with RWC-340B in the suit. Three more have been added:
Little Rivers Health Care, a Vermont federally qualified health center (FQHC)
FamilyCare Health Center, a West Virginia FQHC
Springhill Medical Center, a Louisiana sole community hospital.
Matthew 25 said in yesterday’s court filing that, if it loses its 340B contract pharmacy services, it will have to let go of employees and contractors who help retain HIV/AIDS patients in care, or link them with transportation, housing, linguistic, or food assistance. Little Rivers said it would be unable to continue to provide low-cost drugs needed by patients who cannot afford them. Springhill, a 58-bed hospital that has operated at a loss for the past two years, estimated that it will lose approximately $30,000 per month, or $360,000 annually, due to the four drug manufacturers’ actions.
HHS’s Health Resources and Services Administration (HRSA) “has abandoned its responsibility to enforce the 340B statute’s requirements for contract pharmacies,” the plaintiffs said in their memo in support of their request for relief. “The results of HRSA’s inaction are severe: 1) financially needy patients will no longer have access to discounted drugs and will forgo taking prescribed medications or request less costly medications that may not be as efficacious; 2) some Covered Entities will have to reduce or eliminate the services that they provide to patients, resulting in harm to their patients, an increase in the need for more expensive healthcare services and creating obstacles to the ability of the Covered Entities to carry out their safety net missions; 3) the Covered Entities are deprived of their due process rights; and 4) other manufacturers will be emboldened to stop providing 340B discounts at contract pharmacies, causing some Covered Entities to close operations.”
“The public interest favors the temporary restraining order and preliminary injunction because, if the Covered Entities lose access to the savings generated from the 340B program, our country’s most vulnerable patients will be harmed and the cost of care will be shifted to taxpayers,” the plaintiffs said.