They’re in! Children’s Hospitals Qualify for 340B
September 1, 2009 - HRSA has issued final guidelines allowing children's hospitals into the 340B program. The much-anticipated notice was published in the Sept. 1 Federal Register and took 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 are being required to resubmit their information to the Office of Pharmacy Affairs (OPA).
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.
OPA is departing from standard procedures to expedite enrollment of free-standing children's hospitals in the 340B program. Under traditional guidelines for admission applicable to DSH hospitals, children's hospitals would have to wait to enter the program until the next quarterly update of the 340B-covered entity database, and the earliest most children’s hospitals could qualify would be January 1, 2010.
However, OPA is being flexible with its standard enrollment deadlines to let interested children's hospitals apply for the Oct. 1 start date, and throughout the next quarter. A new federal public health emergency enrollment policy implemented in response to the H1N1 epidemic lets HRSA enter new entities into its database on a case-by-case basis as soon as they're approved by HRSA for participation in the program. A hospital's chance of being admitted prior to Jan. 1, 2010, improves significantly the earlier it submits an application.
The HRSA guidelines require children's hospitals to be recertified annually.
The guidelines permit children’s hospitals to seek 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 made it legal for children's hospitals to participate in the drug discount program, took effect Feb. 8, 2006.
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.
HRSA’s Pharmacy Services Support Center has drafted a backgrounder on Children’s Hospital Eligibility, Participation, and Enrollment. PSSC also has created an education module on 340B for children’s hospitals interested in enrolling in the program.
For children’s hospitals interested in more personal assistance, 340B Health will arrange a complimentary, 30-minute technical assistance call with 340B Health's veteran team of attorneys to discuss the application process. To schedule a call, please contact Andrea Jeria at andrea.jeria@ppsv.com or (202) 872-6770.
340B Health has helped hundreds of DSH hospitals qualify and apply for the 340B program. This experience is directly relevant to children's hospitals now seeking enrollment.
If you have further questions, please feel free to contact 340B Health President and General Counsel Bill von Oehsen at William.vonoehsen@340bhealth.org or 202-872-6765.