HHS has made its fifth request to delay a rule that would set new drug ceiling prices in the 340B drug discount program. The rule was supposed to kick in July 1.
On Tuesday, HHS asked the White House's Office of Management and Budget to push the rule's effective date. If approved, the regulation's release will be delayed for a fifth time. HHS' request did not include a new date for the rule to go into effect.
HHS does not comment on rules pending review by the OMB, according to an agency spokesman.
Under the 340B program, drug companies are required to provide discounts to hospitals and clinics, with the goal of providing low-income patients greater access to medications.
In the past, HHS has sought to delay the rulemaking to address stakeholder opposition. The regulation was first introduced during the Obama administration to determine whether alternative or supplemental regulatory provisions needed to be added to the rulemaking.
In addition to setting new drug ceiling prices, the rule would allow HHS to levy fines against drug manufacturers that intentionally charge a hospital more than the ceiling price.