by admin | September 4, 2013 2:12 pm
September 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[1] (subscription required) that ran in the industry newsletter on Sept. 2. Asay told the publication that hospitals are the company’s primary focus of concern and that it has done “multiple audits” specifically on whether hospitals have bought drugs at a discount, saying that the products were intended for outpatients, but then instead improperly dispensed or administered the drugs to inpatients.
“It’s been clear … on some products that are inpatient products, that the purchases for those products have been made through the 340B program, which is an outpatient program,” Asay said. “So that has been one big cause of concern for us.”
Hospitals say that many drugs that appear to have been used in the inpatient setting have actually been provided on an outpatient basis, a reflection of the trend toward outpatient care and same-day surgeries.
The biotech company Genentech is the only other manufacturer to have revealed that it is auditing 340B providers. Last week, Genentech announced it will be giving refunds to 340B covered entities[2] 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.
In July, the Health Resources and Services Administration (HRSA) reported that it had received seven work plans from drug manufacturers to audit covered entities, six of which it allowed to proceed to actual audits. It said it had received and was reviewing three final audit reports.
HRSA itself audited 51 covered entities in fiscal year 2012 and has completed more than 70 so far this fiscal year, which ends Sept. 30.
Lilly has been one of the most active members of the Alliance for Integrity and Reform of 340B (AIR 340B), the industry-led group that has been highly vocal about alleged program abuses. The group says it stands for:
“In a nutshell, we think the program as it’s currently being implemented has strayed far off from its original intent, which has led unfortunately to abuse and unintended consequences,” Asay said in the Pink Sheet interview. “This is really less about the hospitals and more about a public policy that’s gone awry.”
Congress, he said, “needs to take a look at this program to ask, where is it now compared to what the intention was when it was implemented back in 1992?”
Lilly and other members of AIR 340B say 340B was narrowly intended to provide prescription drugs to the poor and uninsured. Health care providers say the program’s purpose is to help them stretch their federal resources, serve more patients, and provide more comprehensive services.
As the current session of Congress enters its stretch run, no legislation has been introduced to either expand or narrow the program.[/ms-protect-content]
Source URL: https://340bemployed.org/drug-manufacturer-lilly-is-auditing-340b-hospitals/
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