March 25, 2013—Although associations representing 340B hospitals have told the Office of Pharmacy Affairs (OPA) that many cannot meet an April 7 deadline to comply with a new policy clarification on group purchasing, the federal agency has yet to hear that from individual hospitals, OPA Dir. Cmdr. Krista Pedley said last week. And "unless we hear from you around what some of … [Read more...]
340B Recertification Deadline Pushed Back Again
Health centers and others now have until March 22March 19, 2013— The Office of Pharmacy Affairs (OPA) has given community health centers and six other types of 340B covered entities another extension of time to recertify their eligibility for the drug discount program. Health centers and center "look-alikes," hemophilia treatment centers, urban Indian programs, tribal contract/638 programs, black lung programs, and Native … [Read more...]
Senate Rejects Spending Bill Amendment That Had 340B User Fee
Obama administration expected to resurrect proposal later this springMarch 15, 2013—The Senate yesterday defeated an amendment to a government-wide fiscal 2013 spending bill that included language to establish a 340B drug discount program user fee. Sen. Tom Harkin's (D-Iowa) amendment to the Continuing Appropriations Act (H.R. 933), which needed 60 votes to pass, failed by a vote 54 to 45. … [Read more...]
HRSA Drafting All-Inclusive Regulation for 340B
Comprehensive rule would be for entire program, Pedley saysMarch 14, 2013—The Health Resources and Services Administration (HRSA) is developing a comprehensive regulation for the entire 340B drug discount program that, among other provisions, would restate which patients may receive 340B-discounted medicines. Office of Pharmacy Affairs (OPA) Director Cmdr. Krista Pedley disclosed the plan for an omnibus 340B rule during a March 12 … [Read more...]
HRSA Issues Policy Release on 340B Hospital Eligibility
Elaborates on criteria for hospitals not owned or operated by governmentMarch 13, 2013—The Health Resources and Services Administration (HRSA) has added additional detail to its policy on the criteria that hospitals that are not publicly owned or operated must meet to be eligible for 340B drug discounts. In its September 2011 report on 340B, the Government Accountability Office called on HRSA to further specify 340B eligibility criteria for such … [Read more...]
“Significant Changes” Coming to 340B Contract Pharmacy Registration
OPA holding webinar for covered entities on March 20March 12, 2013—The Office of Pharmacy Affairs (OPA) is making "significant changes" to the way that health care providers register contract pharmacies in the 340B drug discount program, the office says in an email that providers began receiving late last week. According to the notification, the changes, which were not described in the email, take effect with the next … [Read more...]
HRSA and OPA Brace for Automatic Spending Cuts
Sequestration's possible effect on 340B program still isn't knownMarch 5, 2013—The Health Resources and Services Administration (HRSA) will have its funding reduced by $605 million for the seven months remaining in fiscal 2013 after Congress and the White House failed to prevent government-wide automatic cuts from taking effect. The effects on the 340B drug discount program, if any, are not yet clear. … [Read more...]