February 4, 2013—The Health Resources and Services Administration (HRSA) has sent the White House Office of Management and Budget (OMB) its draft final regulation to clarify the Affordable Care Act’s (ACA) restriction on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under health care reform.
OMB’s Office of Information and Regulatory Affairs (OIRA), which reviews all federal agencies’ draft rules at both the proposed and final stages of rulemaking, received the orphan drug exclusion final rule from HRSA on Jan. 31, according to a notice on the OIRA website.
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