BREAKING: Rule Implementing 340B Executive Order on Insulin Might be Imminent

Your 340B Report for Monday Sept. 21, 2020

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Rule Implementing 340B Executive Order on Insulin Might be Imminent

The Trump administration signaled today it might publish an interim final rule imminently to implement an executive order requiring community health centers to pass along all 340B savings on insulin and injectable epinephrine to patients.

340B Report learned that the White House Office of Management and Budget (OMB) this morning cancelled virtual meetings with community health center representatives previously scheduled for today. Since Sept. 1, OMB has been reviewing a U.S. Health and Human Services (HHS) interim final rule to implement the order. Health centers say the order is unnecessary and could threaten patient access to affordable prescription drugs.

According to the OMB Office of Information and Regulatory Affairs (OIRA) website, Trump administration and HHS officials scheduled 11 meeting with health center representatives between Sept. 9 and 18. Four more meetings were scheduled for today, four Sept. 22, and three for Sept. 23.

Health centers due to meet with the administration and HHS about the rule implementing the order each received an email stating, “This rule has concluded and your meeting has been cancelled.” The email’s phrasing is ambiguous. It is not clear if the author meant the review of the rule is concluded, or something different.

Normally, when OMB concludes its review of a federal department or agency regulation or guidance document, the regulation or guidance is posted for public inspection on the Federal Register website quickly, sometimes even the day the review ends. Formal publication in the Federal Register usually comes a day or two later. The publication date and effective date may vary.

As of 3:00 p.m. Eastern, the interim final rule implementing the order was still tagged as “pending review” on the OMB-OIRA website.

Interim final rules take effect immediately without notice and comment. OMB reviews and must approve all executive branch regulations and guidance documents before they can be published in the Federal Register.

Last week, more than 100 Democratic U.S. House members asked HHS Secretary Alex Azar to rescind or not implement the executive order.


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