May 11, 2011— The Office of Pharmacy Affairs (OPA) added 150 rural, children’s and cancer hospital sites to its 340B covered entity database on April 1—a 50 percent decline from the number added at the start of the previous quarter.
Two hundred ninety three rural, children’s and cancer hospital sites were added to the database on Jan. 1. Another 599 were added during August and September 2010, when hospitals newly eligible for 340B were enrolled on a rolling basis to speed their admission.
Critical access hospitals (CAHs), sole community hospitals (SCHs), rural referral centers (RRCs) and freestanding cancer hospitals became eligible for 340B under last year’s Affordable Care Act (ACA). Although children’s hospitals had been eligible since late 2009, health care reform transferred the authority for their participation from the Social Security Act to the Public Health Service Act. OPA counts them together with the rural and cancer hospitals as “Affordable Care Act entities.”
OPA adds covered entities to its database four times a year at the beginning of each calendar quarter. The next update to the list will be on July 1.
OPA officials declined to say whether April’s sharp drop-off from January’s enrollment figures came as a surprise. “We do not have additional information regarding the enrollment rate,” the office said in an emailed response to a request for comment.
Asked whether the lack of access to 340B pricing on orphan drugs might be dissuading rural and cancer hospitals from enrolling, OPA said, “we have heard during national conferences that may be the case, but that is the only evidence we have.”
ACA barred rural and freestanding cancer hospitals new to 340B from obtaining discounts on the expensive specialty drugs, which are often used to treat cancer and diseases affecting children. They also include blood factor product used to treat bleeding disorders and expensive IVIG therapies. Many rural and cancer hospitals say the prohibition denies them much of the benefit of enrolling in 340B.
In coming days, the White House Office of Management and Budget (OBM) is expected to complete its review of draft proposed regulations to implement the prohibition on orphan drug discounts. OPA’s parent agency, the Health Resources and Services Administration (HRSA), sent the draft to OMB on Feb. 15. Such reviews are supposed to take no longer than 90 days.