Editor's note: This story has been updated to include a response from 340B Health and the American Hospital Association.
HHS is planning an about-face on the long-delayed rule that would set price ceilings and monetary penalties in the 340B program, moving up its start date by several months.
The Department of Health and Human Services issued a notice (PDF) saying that it intended to finally implement the rule on Jan. 1, cutting off seven months of time from a previously announced July 1 start date.
The rule—which would set price ceilings for drugs and punish pharmaceutical companies that knowingly overcharge 340B hospitals—has been delayed five times by the Trump administration, most recently in June. The final rule was first issued in January 2017.
The Health Resources and Services Administration (HRSA) said the delays were necessary as it needed more time to implement the rule properly and wanted to fully explore possible alternatives or supplemental regulations.
The most recent delay was fueled in part because HHS has made addressing the rising cost of drugs a key priority, and officials were concerned that implementing the rule could impact actions taken under the “American Patients First” plan.
The start date was moved up to Jan. 1, HRSA said in the notice, because it “determined that the finalization of the 340B ceiling price and civil monetary penalty rule will not interfere with the department’s development of these comprehensive policies.”
Four national healthcare organizations sued HHS in September over the delays to the final rule. The American Hospital Association (AHA), America's Essential Hospitals (AEH), the Association of American Medical Colleges (AAMC) and 340B Health all signed on to the suit, which claims that the repeated delays violate the Administrative Procedure Act.
Since the rule was first proposed in 2015, there has been ample time to notify stakeholders and tweak the plan, the groups argued.
“The department’s proffered rationales for their successive delays have shifted and been inconsistent,” according to the lawsuit.
340B Health said in a statement emailed to FierceHealthcare that the group is "encouraged" to see HHS responding to the suit.
“These rules were ordered by Congress more than eight years ago based on clear, documented evidence of overcharging by drug companies of 340B hospitals, clinics, and health centers," interim CEO Maureen Testoni said. "The time for delay is over and now it is time for action.”
AHA echoed the sentiment, saying it hopes HHS "sticks by the commitment" to roll out the rule.
"The rule also requires that HHS make pricing information available online to 340B hospitals and other providers," General Counsel Melinda Hatton said in a statement. "We strongly encourage HHS to publish that website promptly, which is critical to enforcement of the 340B program, as soon as possible after January 1."
HHS has also taken aim at the 340B program by significantly slashing its payment rate. In a rule that took effect at the beginning of fiscal year 2018, the Centers for Medicare & Medicaid Services cut the rate from up to 6% above the average sales price for a drug to 22.5% less than the average sales price.
All told, the change will cut $1.6 billion in drug discount payments. AHA, AEH and AAMC are also challenging that policy in court.