340B Hospitals React to HHS Decision to Delay Regulation That Was Due 2,433 Days Ago
May 18, 2017—340B Health, the association of hospitals and health systems in the 340B drug discount program, is disappointed with the U.S. Department of Health and Human Services’ decision today to further delay, to Oct. 1, a long-overdue regulation to police the pharmaceutical industry. At the same time, we take comfort that, in announcing the delay, HHS declined to withdraw the rule and issue a new proposal, as urged by the drug industry. We also are pleased that HHS did not suggest that still more delay might be necessary.
The 340B drug discount program gives safety-net providers relief from high drug prices. They rely on the savings to fund critical programs for their low-income, uninsured, and underinsured patient populations. In 2010, Congress directed HHS to issue 340B program regulations for determining ceiling prices and imposing civil monetary penalties on manufacturers that “knowingly and intentionally” overcharge providers.
After three rounds of notice and comment, HHS published a final rule on Jan. 5, 2017, with a March 6 effective date and enforcement to begin on April 1. In early March, pursuant to the Trump administration’s regulatory freeze memo to federal agencies, HHS delayed the rule to May 22 and requested comments on a possible additional delay until Oct. 1.
“HHS’s statutory deadline for issuing the CMP regulation was Sept. 19, 2010. That was 2,433 days ago,” said 340B Health President and Chief Executive Officer Ted Slafsky. “We continue to be concerned that further delay of the rule will harm safety-net providers and their patients, especially in this time of skyrocketing drug costs. However, we are pleased that HHS decided not to change a rule that the Health Resources and Services Administration carefully considered and crafted to balance the interests of different program stakeholders.”