The White House Office of Management and Budget (OMB) has completed its review of a key regulatory step toward rescinding the Trump administration’s final 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 final rule currently is due to take effect on July 20.
OMB finished reviewing the U.S. Health Resources and Services Administration’s (HRSA’s) recission proposal yesterday. HRSA could post its proposal, in the form of a proposed rule, for public inspection on the Federal Register website as soon as later today. There probably will be a public comment period, followed by another OMB review, before publication of a final rule later this summer rescinding the Trump-era mandate.
It’s possible HRSA will push back the effective date of Trump’s mandate for 60 days for a third time, before July 20 arrives.
Health centers argued that Trump’s rule ignores that they already make insulin and EpiPens free or affordable to low-income patients. Health centers said the rule would dramatically reduce their 340B savings, impose enormous administrative burdens on them, and likely raise the cost of insulin and epinephrine pens. The requirement, which was unveiled by President Trump at a White House drug pricing event in late July 2020, had few advocates outside of the Trump administration and some conservative news sites.
The Trump administration rule was scheduled to take effect Jan. 22. The Biden administration on Jan. 21 pushed the effective date back to March 22. On March 19, it pushed the date back a second time, to July 20. On May 10, HRSA sent OMB its proposal to rescind the Trump-era rule.
UPDATE June 9, 2021, 11:00 a.m. EDT—A spokesperson for the National Association of Community Health Centers (NACHC) told 340B Report, “During a time when health centers have played an integral role in America’s pandemic response, they have been anxiously waiting for the Biden administration to rescind this harmful regulation.”
“NACHC applauds HRSA for taking a step in the right direction but strongly encourages the Biden Administration to revoke the underlining executive order, which does not serve its intended purpose to increase access to affordable life-saving drugs,” the group said. “Federal regulation and the health center mission demand that every penny of 340B savings is dedicated to expanding access to care among low-income populations.”
