New rules for drug companies in federal discount program start Jan. 1

HHS has finalized a rule bumping up the effective date for long-delayed regulations that would force drug companies to be open about their pricing and punish them for overcharging hospitals under the 340B drug discount program.

The agency published a final rule on June 5 that delayed the effective date to July 1, 2019, "to consider alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking." But HHS said after considering comments on the regulations, it decided to stop further delay and move up the effective date to January.

The American Hospital Association — which joined other national organizations in suing HHS over the delay of the drug-pricing transparency regulations — expressed approval that the most recent final rule ensures the regulations are implemented.

"We continue to strongly urge HHS to make available online drug pricing information for 340B hospitals as this rule requires as soon as possible after Jan. 1, and no later than April 1, so that instances of drug company overcharging can be uncovered and penalties enforced," said Tom Nickels, executive vice president of the American Hospital Association.

The Pharmaceutical Research and Manufacturers of America expressed disappointment, telling Becker's that "the administration did not issue new proposals for this rule as it repeatedly stated it would."

The group said the administration "ignored the numerous concerns raised by stakeholders on the proposed ceiling price calculations, offset policy and civil monetary penalty provisions. Not only is the final rule itself overly burdensome in its requirements, but moving up its effective date also leaves manufacturers with very little time to make operational changes to systems and procedures."


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