The U.S. Health and Human Services Department (HHS) announced late this morning that it will delay, from this coming Monday, March 22 until July 20, the effective date of a Trump administration rule to require health centers to provide insulin and injectable epinephrine to low-income patients at the price the centers pay for those drugs under the 340B program.
The Biden administration is perceived to be sympathetic to the health centers’ concerns and it may decide to scrap the rule altogether. It has withdrawn or delayed a number of last-minute Trump administration health care rules. HHS’s Health Resources and Services Administration’s Administrative Dispute Resolution rule is an exception. Biden has received some criticism from conversative media and conservative interest groups for delaying what they argue would be a cost saver for patients. Health centers strongly disagree that the rule would benefit patients.
(HRSA) posted a notice about the delay for public inspection in advance of its formal publication in the Federal Register next week Tuesday. Health centers say the rule ignores that they already make insulin and EpiPens free or affordable to low-income patients, will deplete revenues that go toward patient care, and is at cross purposes with health centers’ newly expanded role in vaccinating patients against COVID-19.
The rule originally was due to take effect on Jan. 22, two days after Trump left office. The Biden administration immediately delayed its implementation to March 22 as part of a sweeping review of pending regulations. It then sought input about delaying it until July. The U.S. Health and Human Services Department (HHS) said it would use the second delay to consider “whether revision or withdrawal of the rule may be warranted.” HHS said it was specifically interested in reviewing previous comments stating that the final rule would dramatically reduce health centers’ 340B savings, impose enormous administrative burdens on centers, and likely raise the cost of insulin and epinephrine pens.
HRSA received 200 comments on the proposed second delay. All apparently supported the delay and urged the administration to rescind the rule.
The delay gives new HHS Secretary Xavier Becerra time to ponder his 340B strategy as he faces big decisions on a number of issues. This includes whether to appeal a federal district judge in Indiana’s decision on Monday that HHS disregarded procedural requirements when it finalized the 340B administrative dispute resolution rule in January. Becerra had called on former HHS Secretary Azar to penalize the drug manufacturers who have refused or placed limits on 340B discounts in the contract pharmacy setting. The 340B provider community wants quick action to address the matter.