February 28, 2014—The federal Centers for Medicare and Medicaid Services (CMS) has approved California Medicaid's 2009 policy requiring 340B covered entities to "carve in" their Medicaid purchases and to pass their 340B discounts on to Medicaid by billing such drugs at no more than actual acquisition cost (AAC) plus a dispensing fee. … [Read more...]
That Takes Chutzpah
We’ve noticed that Eli Lilly and Co. has been taking pot shots at the 340B program calling for more oversight and transparency. This from a company that agreed to plead guilty and pay $1.4 billion for promoting its antipsychotic drug Zyprexa for uses not approved by the Food and Drug Administration including marketing it to elderly patients with dementia. Health care providers … [Read more...]
Bayer Limiting Distribution of Multiple Sclerosis Drug Betaseron
Customer's 340B status will not affect allotment, company says in letterFebruary 20, 2014—Bayer HealthCare Pharmaceuticals has limited sales of its widely used, genetically engineered multiple sclerosis (MS) drug Betaseron due to inability to meet demand, effective with orders received on or after Jan. 1, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) announced on its website today. … [Read more...]
340B Provider Groups Urge HHS to Address Manufacturer Compliance
Coalition wants OPA funding boost used to police drugmakers more closelyFebruary 20, 2014—Health care providers in the 340B program are urging Health and Human Services (HHS) Secretary Kathleen Sebelius to use the program's $6 million funding boost to make sure that drug manufacturers aren't overcharging for covered outpatient drugs. … [Read more...]
340B Sales Totaled $7.5 Billion in 2013, Apexus Says
New figure indicates 340B's share of total U.S. drug sales is roughly 2%February 14, 2014—Pharmaceutical purchases through the 340B discount program were an estimated $7.5 billion in 2013, the 340B Prime Vendor Program (PVP) reports. Overall U.S. spending on pharmaceutical products in 2012, the most recent year for which data are available, stood at $326 billion, according to IMS Health Informatics Institute. Together, that figure and the new … [Read more...]
HRSA Issuing Regulation on 340B Rebates for AIDS Drug Assistance Programs
Announcement raises questions about 2005 policy guidanceFebruary 13, 2014—The Health Resources and Services Administration (HRSA) plans to propose a rule that will address the extent to which state AIDS Drug Assistance Programs (ADAPs) can collect full 340B rebates from drug manufacturers when the ADAPs pay premiums, copayments, and deductibles on health insurance that they may buy for ADAP clients. … [Read more...]
GAO Study Doesn’t Cite Drug Discounts as a Major Factor in Shortages
At hearing, some lawmakers indicate they will keep pressing the matterFebruary 11, 2014—Halts or slowdowns in manufacturing to address quality problems are the leading immediate cause of drug shortages, especially among generic sterile injectable products, the Government Accountability Office (GAO) concluded in a long awaited report yesterday. It recommended that the Food and Drug Administration (FDA) strengthen its internal controls over its … [Read more...]