The 340B Drug Pricing Program Omnibus Guidance (MegaGuidance) was published for public comment August 28, 2015. This Mega-Guidance can be found HERE. The proposed Mega-Guidance adds that a child site should have “associated outpatient Medicare cost and charges on the most recently filed Medicare cost report to demonstrate the child site’s eligibility. This is different from the 1994 Final Notice on Outpatient Hospital Facilities posted in the Federal Register and different from any previous OPA guidance provided in OPA’s FAQs.
As It Stands Now:
“The outpatient facility is considered an integral part of the “hospital” and therefore eligible for section 340B drug discounts if it is a reimbursable facility included on the hospital’s Medicare cost report. For example, if a hospital with one Medicare provider number meets the [DSH] criteria and this hospital has associated outpatient clinics whose costs are included in the Medicare cost report, these clinics would also be eligible for section 340B drug discounts”.
(Fed Reg/Vol. 59, No. 180 / Monday, September 19, 1994, Final Notice)
Proposed Clarification:
“the services provided at each of the facilities or clinics have associated outpatient Medicare costs and charges”.
Hospitals may have multiple 340B child sites that do not see Medicare patients and would not have associated Medicare cost and charges such as pediatric clinics, free clinics, etc. We encourage hospitals to review their child sites and see if any child sites would be removed from the 340B program because they do not have associated Medicare cost and charges. Hospitals should calculate the impact on their 340B savings if the child site and contract pharmacy prescriptions generated from the child site were to be eliminated. Comments are due by October 27th and should include the loss of savings and any patient programs that may be impacted due to the loss.
