February 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. … [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. … [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. … [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...]
Celgene Posts Notice on 340B Program Website
Explains why it stopped adding 340B and other providers to limited distribution networksJanuary 30, 2015—The biotech company Celgene, acting at the request of the Health Resources and Services Administration, has posted a notice on the 340B program website explaining why it has stopped adding providers to its limited distribution networks for three of its products, including its top-selling blood cancer drug Revlimid. … [Read more...]
340B Recertification Underway for Health Centers and Most Grantees
Hospitals and Title X centers excluded from current batchJanuary 30, 2015—Annual recertification of 340B eligibility for all enrolled providers other than hospitals and Title X family planning clinics began on Jan. 28 and will end on March 11, according to a notice on the Health Resources and Services Administration Office of Pharmacy Affairs home page. … [Read more...]
HHS Asks Court to Dismiss 340B Orphan Drug Exclusion Lawsuit
Drug industry's response is due by Feb. 25January 29, 2015—Attorneys for the Department of Health and Human Services have asked a federal district judge to dismiss the drug industry's lawsuit against the 340B orphan drug exclusion interpretive rule. … [Read more...]