On May 27, HRSA submitted
a prerule document titled “Notice Regarding 340B Rebate Model Pilot Program” to
the White House Office of Management and Budget (OMB) for review. Although the
document's contents are not yet public, its submission suggests that HRSA has
not abandoned the rebate model pilot despite significant stakeholder
opposition.
The purpose of the prerule notice remains unclear. HRSA may
be preparing guidance proposing a revised pilot and summarizing comments
received in response to its February 17 request
for information (RFI). Alternatively, the agency may be planning to issue a
second RFI to gather additional stakeholder input. Either way, the submission
indicates that HRSA continues to advance the rebate model and that stakeholders
are likely to have another opportunity to comment.
Although most rules and guidance documents submitted to OMB
are ultimately published, OMB review does not guarantee publication. During the
review process, interested parties may request meetings with HRSA and OMB
through the OMB
website to discuss the proposal. Stakeholders should be aware that OMB
publicly discloses the occurrence of such meetings, identifies attendees, and
posts any materials submitted before or during the meeting.
Although HRSA submitted the prerule document only a few months after issuing the RFI and information collection request (ICR), any new rebate model pilot is likely still months away from implementation. After federal courts invalidated HRSA's original rebate pilot, which was scheduled to take effect on January 1, HRSA agreed that any future pilot would not become effective until at least 90 days after the agency approves participating manufacturers' applications.
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