by admin | February 13, 2013 2:42 pm
February 13, 2013—A coalition representing drug manufacturers, pharmacy benefit managers, private practice oncologists, and independent pharmacies issued a report[1] yesterday on hospital participation in the 340B drug discount program, arguing that hospitals have strayed from what the groups maintain is 340B’s purpose of helping the uninsured poor “gain better access to prescription medicines.”
Hospitals disputed that finding, saying in a statement[2] that the program meets Congress’ intent of enabling safety-net providers to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”[ms-protect-content id=”2799″]
Congress, the executive branch, and investigatory agencies have made it clear that using 340B-discounted drugs for insured patients and billing third-party payers at normal rates is consistent with and necessary to advance that broader purpose, the hospitals said.
Hospitals also took strong exception to the coalition’s assertion that ways in which some hospitals use 340B may lead to “potentially harmful consequences for patients.”
“We are deeply dismayed that the report includes unfounded insinuations that some hospitals are putting patients in harm’s way to maximize 340B savings,” said Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents 340B hospitals. “This is an affront to the integrity of safety-net caregivers across the country.”
Yesterday’s report was issued by the drug industry trade groups Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization; the private practice oncologist group Community Oncology Alliance; the independent pharmacy group National Community Pharmacists Association, the drug company-funded National Patient Advocate Foundation; and the PBM group Pharmaceutical Care Management Association.
The report was published on the same day as a New York Times article[3] that explores the division between drug companies and hospitals over 340B’s purpose.
The report also comes as (1) a group of Republican members of Congress continue an inquiry[4] into 340B; (2) just days after the Health Resources and Services Administration (HRSA) issued guidance[5] on 340B hospital usage of group purchasing organizations; and (3) as HRSA begins a second and much larger round of 340B covered entity audits[6] and as manufacturer audits of providers begin in earnest.
The coalition acknowledges that “340B is important today and going forward for the many patients who are dependent on this program.” It concludes, however, that:
Congress created 340B specifically “to help uninsured indigent patients gain better access to prescription drugs,” they say. In their view, use of the program “for insured patients, at a profit, with no formal guarantee or evidence that the discount flows to the patient,” is contrary to congressional intent.
“Because of the potentially serious consequences that could evolve from these and other findings, Congress should conduct a thorough examination of the 340B program to ensure it is meeting its original goals,” the groups say.
Among the report’s recommendations:
“Without concerted efforts to achieve program integrity, the potential for program misuse is high,” the report concluded.
SNHPA, the association of 340B hospitals, said that while it agrees with parts of the report, the document “is full of misinformation and contains many unsubstantiated assertions.”
Contrary to the industry coalition’s assertions in its report, SNHPA said, “hospitals do, in fact, use program savings to improve care for eligible patients—exactly as Congress intended.” The program, it added, “saves money not just for patients, but for all taxpayers.”
The hospital group said:
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