Facing a legal challenge from the hospital industry, the Health Resources and Services Administration has proposed a January 1, 2019 effective date of a rule to establish a system to verify ceiling prices for 340B drugs, to provide web site access to the ceiling prices, and to impose civil monetary penalties on manufacturers who overcharge 340B providers. The issuance of the rule was mandated by the Affordable Care Act in 2010. After a long delay, HRSA issued a final rule in January 2017, which was subsequently delayed five separate times, most recently to July 1, 2019.
