April 9, 2014—The Health Resources and Services Administration has sent its proposed 340B “mega-reg” to the White House Office of Management and Budget for review prior to its publication in the Federal Register, according to a notation today on the OMB website. [ms-protect-content id=”2799″] If the review takes the typical length of time and ends with OMB granting its approval, the regulation would come out shortly after Independence Day. HRSA has said there will be a 60-day comment period for the regulation, which is expected to cover the definition of an eligible patient, contract pharmacy arrangements, hospital eligibility criteria, and eligibility of off-site facilities.
OMB review of federal regulations should take no more than 90 days. There is no minimum period. OMB can extend the review on a one-time basis for no more than 30 days and the rulemaking agency can extend it indefinitely. In 2013, OMB took an average of 93 days to review rules such as the mega-reg considered “economically significant.” When the review is complete, OMB can clear the regulation for publication or send it back to the agency for further consideration.
Safety Net Hospitals for Pharmaceutical Access, which represents 340B hospitals, said in a statement that it “looks forward” to the regulation and urges the Obama administration “to draw upon our member hospitals’ experience caring for low-income and other vulnerable patient populations.”
“Since its enactment, the 340B program has lowered drug costs for safety-net hospitals and other health care providers,” the group said. “These discounts enable them to stretch their scare resources so they can serve more patients and provide more comprehensive services, just as Congress intended. The forthcoming regulation should be written in a way that enables our member hospitals to continue meeting those objectives.” [/ms-protect-content]