HHS's latest semi-annual regulatory agenda is mum on 340B, but that doesn't mean there is nothing 340B-related in the pipeline. | Shutterstock

HHS’s Latest Regulatory Agenda Is Silent on 340B, but Program Rulemaking Is Possible

The U.S. Health and Human Services Department (HHS) yesterday released the spring edition of its twice-annual public inventory of forthcoming regulatory actions. Although it was silent about the 340B program, 340B stakeholders shouldn’t breathe a sigh of relief yet.

Just because HHS’s latest semi-annual regulatory agenda is mum about 340B, that doesn’t mean there is nothing 340B-related in HHS’s regulatory pipeline, or that something could be added later.

For example, the agenda did not include continuing activity at HHS about the Trump administration’s final rule requiring 340B health centers to provide insulin and injectable epinephrine devices like EpiPens at 340B acquisition cost to patients with low incomes.

The Biden administration on March 19 pushed back the rule’s effective date, from March 22 until July 20. It originally was set to take effect on Jan. 22 but the new administration delayed it for 60 days. Health centers are strongly against the rule. They say it ultimately would do little good and considerable harm. The Biden administration said it is considering revising or withdrawing the rule.

How HHS Secretary Xavier Becerra decides to deal with emerging legal challenges to the 340B administrative dispute resolution (ADR) final rule also is not covered in HHS’s new agenda. Because this is a new development, its exclusion from the agenda is not a surprise.

A federal district judge in Indianapolis last month temporarily enjoined HHS from holding 340B administrative dispute resolution (ADR) proceedings against drug manufacturer Eli Lilly. U.S. District Judge Sarah Evans Barker said Lilly has made a strong case that HHS, during the Trump administration, disregarded procedural requirements when it published the 340B ADR final rule in December. Barker said she assumed HHS will want to promulgate a procedurally valid rule expeditiously. HHS has not yet said how it will respond to the temporary injunction. Drug manufacturer Sanofi is also challenging the 340B ADR rule in court.

HHS’s spring agenda says that the Centers for Medicare & Medicaid Services (CMS) aims to publish its annual proposed rule for the Medicare hospital outpatient prospective payment system (OPPS) in June. 340B program stakeholders are waiting to find out if the Biden administration will end or continue a nearly 30 percent cut in many 340B hospitals’ Medicare Part B drug reimbursement that the Trump administration implemented starting in 2018.

A number of groups representing 340B hospitals have strongly objected to the cuts and are currently asking the U.S. Supreme Court to intervene. For profit-hospitals support the cuts and have launched a concerted effort to retain them.

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