September 12, 2013—The Department of Health and Human Services Office of Inspector General (OIG) has urged the Centers for Medicare and Medicaid Services (CMS) to consider calling for the enactment of a Medicare Part B drug rebate program. … [Read more...]
Onyx Pharmaceuticals Providing 340B Refunds on Kyprolis
Gives providers until end of this year to claim repayment for overchargesSeptember 9, 2013—Biopharmaceutical manufacturer Onyx, which is being purchased by biotech giant Amgen for $10.4 billion, has announced that 340B covered entities that bought its injectable oncology medication Kyprolis during the first quarter of 2013 might be eligible for refunds for overcharges. … [Read more...]
HRSA Releases Findings From 8 More 340B Provider Audits
42 down and 9 to go out of the 51 audits performed in 2012September 5, 2013—The Health Resources and Services Administration (HRSA) has released eight more brief summaries of findings from its audits of 340B covered entities in 2012, bringing the total to 42 out of 51 audits conducted last year. … [Read more...]
HRSA Publishes 340B Orphan Drug Exclusion List
Registry will govern sales covered by new regulation beginning Oct. 1September 4, 2013—The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) has published its first quarterly list of orphan drugs subject to exclusion from 340B pricing in certain circumstances. … [Read more...]
Drug Manufacturer Lilly Is Auditing 340B Hospitals
Focus is on perceived drug diversion to inpatients, executive saysSeptember 4, 2013—Eli Lilly & Co. is the second known drug manufacturer to obtain federal approval to conduct its own audits of 340B covered entities, it has emerged. … [Read more...]
Genentech Issuing Refunds for 340B Overcharges
Notice covers 19 products sold between 3Q 2008 and 2Q 2011(UPDATED September 3, 2013 with comment from Genentech) August 29, 2013—The biopharmaceutical giant Genentech will be providing refunds to 340B covered entities on 19 of its products sold from the third quarter of 2008 through the second quarter of 2011 due to a recalculation of its Medicaid average manufacturer prices and best prices, according to a notice by the company … [Read more...]
HHS Report Urges Huge Reduction in Critical Access Hospitals
Roughly 65% of CAHs receive 340B drug discountsAugust 19, 2013—A Department of Health and Human Services (HHS) Office of Inspector General (OIG) report recommending a nearly two-thirds cut in the number of critical access hospitals (CAHs) would "kill rural health care," the National Rural Health Association (NRHA) says. … [Read more...]