The U.S. Department of Health and Human Services has again delayed the effective date of enforcing the final rule for the 340B drug pricing program to May 22, and may delay it further to Oct. 1.
The rule was supposed to go into effect on April 1, a delay from March 21. It would impose civil monetary penalties for drug manufacturers who intentionally charge a provider in the 340B program more than the ceiling price for the covered outpatient drug.
The overhaul of the 340B program was introduced under President Barack Obama, leaving in question its eventual outcome. Earlier this year, the Trump administration issued a regulatory freeze so that new appointees could review the regulations.
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The Centers for Medicare and Medicaid Services twice delayed implementing the final rule after getting more than 100 comments, many from providers concerned that the rule restricted the definition of patients who were eligible to receive the discounted drugs, and the drugs subject to the discounts. The rule had restrictions on when providers could use a 340B drug.
However, the association 340B Health said it was disappointed by the HHS delay.
By specifying how 340B ceiling prices should be calculated, the regulation would help ensure those prices are right, it said.
"This much-needed regulation has been many years in the making and included two opportunities for the public to submit comments," 340B Health President and CEO Ted Slafsky said. "It was mandated by Congress and is based on HHS Office of Inspector General reports that showed pharmaceutical manufacturers were routinely overcharging providers serving the poor."
The rule also established a controversial penny pricing policy for drugs when the calculation equaled zero.
Under the new rule, a drug manufacturer that knowingly overcharged a 340B hospital or other 340B provider could be fined up to $5,000 for each offense. Manufacturers would also have to ensure that their distributors give providers the 340B ceiling price.
HHS intends to engage in longer rulemaking, it said. It is also accepting comments through April 19, on pushing out the final rule to Oct. 1.