A proposed replacement for the 340B administrative dispute resolution (ADR) process has been under White House review for more than half a year. It seems to be no closer to publication for notice and comment than it was when it got to the White House last November.
The U.S. Health Resources and Services Administration (HRSA) sent the proposed rule to the Office of Management and Budget (OMB) for approval on Nov. 18, 2021. At the time, the projected timetable for publication was January 2022. In December 2021, the Biden administration provided more details on its plans, announcing that it wanted to replace the ADR regulation which was enacted in the last days of the Trump administration, with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.”
A proposed replacement for the 340B administrative dispute resolution (ADR) process has been under White House review for more than half a year. It seems to be no closer to publication for notice and comment than it was when it got to the White House last November.
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