February 12, 2015—More information about the first 340B program audit of a drug manufacturer emerged today during a drug industry government pricing conference in Washington.[ms-protect-content id="2799"] Speaking at the Government Drug Pricing Forum in Washington, Ann Maxwell of the Department of Health and Human Services Office of Inspector General revealed that auditors … [Read more...]
340B Keeps Dollars from Pharma R&D?
Big Pharma says that lost profits from the 340B drug discount program impact investments in research and development. Really? That doesn’t square with a new Vox infographic that shows nine out of 10 major pharmaceutical companies spent far more on sales and marketing than R&D in 2013. Johnson & Johnson spent $8.2 billion on research and development but blew more than … [Read more...]
Hospitals Back HHS in 340B Orphan Drug Lawsuit
Groups file briefs defending HRSA's interpretive ruleFebruary 11, 2015—Hospital groups have asked a federal district judge to dismiss the drug industry's lawsuit challenging the 340B orphan drug exclusion interpretive rule.[ms-protect-content id="2799"] The four groups – Safety Net Hospitals for Pharmaceutical Access, National Rural Health Association, America's Essential Hospitals, and the American Hospital Association – made … [Read more...]
340B Omnibus Guidance Slated for June Release
Regulations coming on manufacturer penalties, ceiling prices, and dispute resolutionFebruary 5, 2015—The Health Resources and Services Administration plans in June to issue wide-ranging 340B program guidance on patient definition and other issues over which it lacks clear authority to regulate, the head of HRSA's Office of Pharmacy Affairs said today. [ms-protect-content id="2799"] In a videotaped address during the 340B Coalition winter meeting in San … [Read more...]
HRSA Names Drugmakers Not Following 340B Orphan Drug Rule
Says purpose is to enable states to collect Medicaid rebatesFebruary 5, 2015—The Health Resources and Services Administration today identified 13 drug companies that are not complying with its 340B orphan drug exclusion interpretive rule. [ms-protect-content id="2799"] HRSA posted the list on the Office of Pharmacy Affairs website. The companies are: AuroMedics Pharma LLC Baxter International Inc. Bayer AG Eisai Co., … [Read more...]
President Seeks $24.73 Million for 340B Oversight and Operations
Patient definition and hospital eligibility guidance "to be finalized" in fiscal year 2016February 2, 2015—The Obama administration is seeking $24.73 million to run the 340B drug discount program in the fiscal year that begins in October – more than double this year's funding level. The request came in the proposed fiscal year 2016 budget that the President sent to Congress today. [ms-protect-content id="2799"] The administration is asking Congress to boost … [Read more...]
Reducing or Eliminating 340B “Could Cripple Safety Net”
At a time when Medicaid and Medicare reimbursement rates continue to shrink, reducing or eliminating 340B could cripple safety net providers across the U.S., the president of the Institute for Healthcare Innovation writes today in Healthcare Finance. "Without a strong and vibrant 340B program, safety net providers may not be able to afford high-priced medications developed by … [Read more...]