September 1, 2009 – HRSA has issued final guidelines allowing children’s hospitals into the 340B program. The much-anticipated notice will be published in the Sept. 1 Federal Registerand take effect immediately.
Because the supporting documentation that must be submitted under the final guidelines differs from what was required in the July 2007 proposed guidelines, hospitals that already filed papers to join will be required to resubmit information to the Office of Pharmacy Affairs.
The new documentation requirements – outlined in Subsection D of the guidelines – will be used, among other things, to calculate what a children’s hospital’s disproportionate-share percentage would be if the hospital received Medicare DSH payments.
Like DSH hospitals, children’s hospitals must wait to enter the program until the next quarterly update of the 340B-covered entity database. Those that successfully qualify and apply for 340B status would be able to start purchasing and using 340B drugs as early as October 1.
The guidelines permit retroactive discounts between Feb. 8, 2006, and the first day a children’s hospital becomes eligible to participate in the program, but only if the hospital meets a series of conditions, including the prohibition against purchasing covered outpatient drugs through a group purchasing organization during the retroactive period.
The Deficit Reduction Act, which went into effect Feb. 8, 2006, made it legal for children’s hospitals to participate in the drug discount program.
OPA has eliminated a 120-day limitation from the date of publication of the final guidelines for seeking retroactive rebates, a provision included in the proposed guidelines. Instead, children’s hospitals will have 30 days from their first date of program eligibility to seek retroactive rebates from the manufacturer.
The HRSA guidelines require children’s hospitals to be recertified annually.
We will publish a more extensive article about HRSA’s new guidelines in coming days.