November 11, 2011—The Health Resources and Services Administration (HRSA) plans to begin its first-ever audits of 340B covered entities beginning in February 2012 and to publish the results two to three months later, the agency revealed in response to questions from three influential Republican members of Congress. The agency also said it plans to send a policy letter to … [Read more...]
Senators Call for Hearing on Legislation to Alleviate Drug Shortages
Request closely follows President Obama's executive order broadening notification requirement.November 11, 2011—Four U.S. Senators yesterday called for a Senate hearing on possible legislative solutions to the growing problem of drug shortages. The letter by Sens. Amy Klobuchar (D-Minn.), Bob Casey (D-Pa.), Richard Blumenthal (D-Conn.) and Jeff Merkley (D-Ore.) to the Senate Health, Education, Labor and Pensions (HELP) Committee comes on the heels of President … [Read more...]
Grassley Warns of “Potential Abuse” of 340B Drug Discounts
Tells HRSA "to get a handle on" the program.November 9, 2011—The Health Resources and Services Administration (HRSA) "needs to get a handle on potential abuse" in the 340B drug discount program "before program growth gets out of hand, the taxpayers have to pay for it, and program sustainability is in question," the ranking Republican member of the U.S. Senate Judiciary Committee said today. Sen. Chuck Grassley … [Read more...]
HRSA to Ease Roadblock for Adding New 340B Outpatient Sites
Agency announces special policy exception to address cost reporting software delay.November 9, 2011—340B hospitals that have not been able to add outpatient facilities to the program because a form and software that they need for enrollment are still being developed can use last year's form and software instead, the Health Resources and Services Administration (HRSA) has decided. HRSA announced the "special exception policy" on the Office of Pharmacy … [Read more...]
GSK Agrees to Settlement to End U.S. Inquiry into Nominal Pricing
Unclear whether 340B providers would share in provisional $3 billion agreement.November 9, 2011—It remains to be seen whether 340B providers will share in the potentially record-breaking $3 billion that drug manufacturer GlaxoSmithKline (GSK) agreed in principle last week to pay to settle multiple federal investigations of its pharmaceutical marketing and pricing methods, including a years-old inquiry into its nominal pricing practices. In a Nov. 3 … [Read more...]
Talk of 340B Drug Diversion and Audits Heats up Following GAO Study
Former OPA Director Mitchell says increased congressional oversight is forthcoming.October 28, 2011—Drug manufacturers are pleased that last month's Government Accountability Office (GAO) report on 340B drug discounts has opened what they feel is a long-overdue conversation about drug diversion in the program, industry attorneys and consultants say. According to industry advisers, loose program guidance and lax oversight have encouraged 340B hospitals and … [Read more...]
Vermont Medicaid’s Changes to 340B Reimbursement Still Up in the Air
State plan amendment features acquisition-cost billing plus enhanced dispensing fees.October 21, 2011—More than six months after submitting required paperwork to Washington, Vermont Medicaid officials are still waiting for the Centers for Medicare and Medicaid Services (CMS) to formally approve changes the state made in late March in the way it reimburses 340B providers' drug costs. The state had expected a response by June 28 and the delay is raising questions … [Read more...]