July 29, 2010 - Federal Office of Pharmacy Affairs (OPA) officials explained during a webinar yesterday how enrollment for hospitals newly eligible for 340B drug discounts will work. But they took a pass on answering some hard questions about retroactive discounts, the definition of an outpatient, billing Medicaid for 340B drugs, and the lack of discounts for purchases of orphan drugs.
The hour-long session was intended mainly to answer basic enrollment questions for free-standing cancer hospitals, critical access hospitals, sole community hospitals and rural referral centers that became eligible for 340B under the Affordable Care Act (ACA). But among the many nuts-and-bolts questions were a few that touched on some of the program's thorniest issues.
Rolling Admission for New Types Only
The officials reiterated that admission for the new types of hospitals would begin on Aug. 2 and that through Sept. 30 they will be entered in the rolls as quickly as their applications are processed. Normally, hospitals, health centers and others seeking to join 340B are admitted only four times a year, on Jan. 1, April 1, July 1, and Oct. 1. Only the new types of hospitals will be admitted to 340B on a rolling basis during August and September. All other types seeking enrollment will have to wait until Oct. 1.
Hospitals that used now-outdated OPA application forms, for example crossing out the words "disproportionate share hospital" and replacing it with their own designation, were told they might have to resubmit all or part of their applications using new forms. Rural referral centers that can quality for 340B also as DSH hospitals were also told they would have to choose between the two designations when applying.
OPA staff members warned the newly eligible hospitals that if they waited until the last minute to apply during the two-month rolling admission window, they ran the risk of not obtaining access to 340B prices until Jan. 1, 2011. They also said a new enrollee's access to 340B pricing would be effective on the day they are formally informed that their application has been approved, rather than on the day they file. On a closely related note, OPA analyst Brad Lang said the office could not yet answer whether new hospitals enrolled in 340B would be able to seek discounts retroactive to Jan. 1, 2010, as specified in the health care reform law.
No Answers for Now to Other Questions
Lang also said he was unable to answer a participant's question about how to tell whether any given patient met the Health Resources and Services Administration's definition of who can be counted as a patient under 340B. He also directed participants to refer to state laws and regulations for questions related to billing Medicaid for 340B drugs, and to the language of ACA for questions about its provision preventing the new classes of hospitals from buying orphan drugs at 340B prices.
In response to a drug manufacturer's question about verifying hospitals' eligibility during the rolling admission period, Lang said it would be up to companies to check OPA's covered entity database frequently.
PowerPoint slides from the webinar will be posted on the OPA Web site in coming days.