The federal government will delay for the second time the date the final rule on the 340B drug discount program takes effect. The rule would penalize pharmaceutical companies that knowingly overcharge hospitals for drugs purchased under the program.
In an interim rule posted Monday to the Federal Register, the agency pushes the effective date of the rule to May 22, and follows a similar move at the beginning of the month to delay its effective date to March 21. The Health Resources and Services Administration (HRSA) under the Department of Health and Human Services will also accept further comment between now and April 19 to determine if another delay to October is worth pursuing. The rule was originally supposed to take effect on March 6.
The rule’s implementation was also delayed by a regulatory freeze issued by the Trump administration at the end of January. That freeze also had an impact on several other HHS rules so that President Donald Trump's new appointees could review the regulations.
Initially, HHS intended to begin enforcing the 340B final rule on April 1 after it took effect, but the delay raised new questions about the provisions in the rule.
“After further consideration and to provide affected parties sufficient time to make needed changes to facilitate compliance, and because there are substantive questions raised, we intend to engage in longer rulemaking,” according to the rule. “In addition, HHS believes that it is important to ensure that this rulemaking—as well as the implementation of this rule—is coordinated with and takes into consideration overall 340B Program implementation.”
The final rule would allow HHS to issue fines of up to $5,000 to drug makers that overcharge hospitals for medications under the 340B program. The rule also included methodology for drug companies to follow when estimating the ceiling cost of a new covered outpatient drug.
Ted Slafsky, CEO of 34OB Health, a membership organization made up more than 1,200 public and private nonprofit hospitals and health systems that are enrolled in the 340B drug pricing program, said in a statement the group was “disappointed” by the delay.
“This much-needed regulation has been many years in the making and included two opportunities for the public to submit comments,” Slafsky said. “Correct 340B pricing and enforcement of manufacturers’ 340B obligations are vital for hospitals to be able to meet their missions to care for the underserved.”