According to a Federal Register post, “this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled ‘Implementation of Executive Order on Access to Affordable Life-saving Medications,’ published” in December 2020.
The agency added that the “temporary delay in the effective date of this final rule is necessary to give Department officials the opportunity for further review and consideration of new regulations, consistent with the memorandum of January 20, 2021.”
The action, according to the White House chief of staff Ron Klain, is part of its attempt to excoriate former President Donald Trump’s health policies and other executive orders.
Klain published a directive that bars new regulations for 60 days while the new administration can carry out an examination. The insulin and epinephrine rule was scheduled to have gone into effect on Jan. 22.
“With respect to rules that have been published in the Federal Register, or rules that have been issued in any manner, but have not taken effect, consider postponing the rules’ effective dates for 60 days from the date of this memorandum, consistent with applicable law and subject to the exceptions described in paragraph 1, for the purpose of reviewing any questions of fact, law, and policy the rules may raise,” Klain wrote.
He explained: “For rules postponed in this manner, during the 60-day period, where appropriate and consistent with applicable law, consider opening a 30-day comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by those rules, and consider pending petitions for reconsideration involving such rules.”
According to a Bloomberg Law article, critics of the Trump rule said that health centers giving the two drugs “already pass on those savings and this [Trump] rule is merely an administrative burden that paints them as entities that price-gouge patients.”
Trump also last year signed an executive order to reduce drug prescription prices.
“It is unacceptable that Americans pay more for the exact same drugs, often made in the exact same places,” his September 2020 order reads.
The order had called on the HHS secretary to “immediately take appropriate steps to implement his rulemaking plan to test a payment model,” and perform a “most favored nations” policy.
As a result of HHS’ freeze, the effective date of the 340B Insulin Pass-Through Rule has now been delayed until at least March 22, 2021.