September 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.[ms-protect-content id="2799"] The Health Resources and Services Administration … [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.[ms-protect-content id="2799"] HRSA's Office of Pharmacy Affairs (OPA) posted the new audit findings on its website late in the day on … [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.[ms-protect-content id="2799"] OPA said on its website that the list, which it complied yesterday, will govern all sales subject to the 340B orphan … [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.[ms-protect-content id="2799"] The disclosure came in an interview with Lilly Senior Director of Government Strategy for Federal Accounts Derek Asay by The Pink Sheet (subscription required) that ran in the … [Read more...]
The Many Ways 340B Is Making a Positive Difference
Setting the record straight about 340B involves more than just responding to the program's critics and pointing out where they’ve bent the truth or worse. Setting the record straight also means telling the story of how safety net hospitals and other caregivers use their 340B savings to meet the program's purpose of stretching scarce federal resources, serving more patients, and … [Read more...]
Genentech Overcharges Underscores Need For HRSA Action
Genentech, the biotech giant leading the charge for drug manufacturer audits of 340B safety net health care providers, admitted yesterday that it overcharged those caregivers for a big chunk of its entire product line from the middle of 2008 through the middle of 2011. The California-based company's Swiss owner, F. Hoffmann-La Roche AG, racked up 9.54 billion Swiss francs in … [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...]