340B Health


in 340B Health News Releases

WASHINGTON, D.C.— 340B Health today urged the federal government to proceed with plans to begin enforcing protections against drug price overcharging on Jan. 1, 2019. In comments filed with the Health Resources & Services Administration (HRSA), we noted that “adequate enforcement of manufacturers’ pricing obligations is key to the success of the 340B program.”

On Oct. 31, HRSA published a proposed rule to expedite the enforcement date to Jan. 1, 2019. This would end a period of delay of more than eight years. “Timely implementation of this rule is critical given the fact that providers currently have no actionable remedies available to address manufacturer overcharges,” our letter says. 340B Health represents more than 1,400 hospitals and health systems participating in the 340B drug pricing program.

In 2010, Congress ordered new civil monetary penalties (CMP) for drug manufacturers that “knowingly and intentionally” overcharge 340B providers for covered drugs. The law provided for a fine of up to $5,000 per incident. The Obama administration published final rules implementing the law in January 2017 but the incoming Trump administration delayed the rules five times, most recently until July 1, 2019. On Sept. 11, 340B Health, along with other national hospital associations, filed suit in federal court challenging the delay and therefore are pleased with the release of this proposed rule to expedite implementation.

In our letter, 340B Health also urged HRSA to “release the secure website providing access to 340B ceiling prices for all 340B-eligible drugs as quickly as possible.” HRSA has said it could release the site soon after the CMP rules were implemented. “Publication of the website will grant 340B providers the necessary transparency in order to verify that they are not being overcharged for 340B drugs and the ability to bring any discrepancies in drug ceiling prices to HRSA’s attention,” our letter adds.

Contact: Richard Sorian at richard.sorian@340bhealth.org or 202-536-2285.