In 2010, the Affordable Care Act (ACA) directed the Secretary of
Health and Human Services to issue regulations to establish an
administrative dispute resolution (ADR) process for certain claims
between Section 340B covered entities and pharmaceutical
manufacturers (e.g., claims of overcharging by manufacturers and
claims of covered entities taking duplicative discounts or
diverting Section 340B discounted product). The ACA directed the
Secretary to issue such regulations within 180 days of the
ACA's enactment.
The Secretary had long failed to issue such regulations, leading
to recent and ongoing Administrative Procedure Act (APA) litigation
by covered entities challenging the Secretary's failure to do
so in connection with the ongoing controversy between covered
entities and certain manufacturers over covered entities' use
of contract pharmacies.
