January 14, 2014—If the federal government's legal defense of the 340B orphan drug regulation is successful, it might have to send Sherlock Holmes a thank-you note. [ms-protect-content id="2799"] In a Jan. 10 court filing, the government said the drug industry's argument that the Health Resources and Services Administration (HRSA) lacked authority to issue the regulation and … [Read more...]
Will 2014 Be the Year of the 340B Mega-Reg?
A rundown of what's in store for 340B in the coming yearJanuary 10, 2014—With just one exception, the federal government has always managed the 340B program without formal regulations, setting 340B's rules of the road instead through guidelines, policy releases, FAQs, and the like. [ms-protect-content id="2799"] All of that could begin to shift in 2014 if the Health Resources and Services Administration (HRSA) achieves its … [Read more...]
The True Number of 340B Contract Pharmacies
Perhaps the most misreported number in the 340B debate is the number of pharmacies that have contracts with 340B healthcare providers. That number currently stands at 13,833. Not 41,051. The confusion comes from the way the Office of Pharmacy Affairs tracks contract pharmacies in its database. Instead of listing these brick-and-mortar stores only once, the agency counts the … [Read more...]
HRSA Issues Last Two 340B Provider Audit Summaries for 2012
Plans to use results to develop best practicesJanuary 10, 2014—The Health Resources and Services Administration (HRSA) yesterday released the remaining two summaries of the 51 audits of 340B covered entities it performed in fiscal year 2012. HRSA's latest update also includes brief descriptions of how some audits were resolved. Many of the audits are still not final, however.[ms-protect-content id="2799"] "The findings … [Read more...]
340B Drug Purchases Are Just Shy of $7 Billion Annually
HRSA supplies figure in a filing in orphan drug exclusion lawsuitJanuary 9, 2014—The dollar amount of pharmaceuticals purchased through the 340B program has been a guesstimate—until now. [ms-protect-content id="2799"] In recent court filings, the federal government supplied a never-before-seen, precise tally of $6,941,926,458.00 for fiscal year 2012. The data came to light as part of Pharmaceutical Research and Manufacturers of America's … [Read more...]
Hospitals Provided $45.9 Billion in Uncompensated Care in 2012, Study Shows
1 in 3 Americans incur medical debts, mainly due to high cost-sharing plans, separate report findsJanuary 8, 2014—U.S. hospitals provided a record-high $45.9 billion in unreimbursed care to indigent and underinsured patients in 2012, an 11.7 percent increase over 2011, according to a new American Hospital Association (AHA) report. [ms-protect-content id="2799"]Hospitals in the 340B drug discount program supply 66 percent of all uncompensated hospital care in America, AHA … [Read more...]
PhRMA: Strike 340B Data in Orphan Drug Case
PhRMA has asked a federal judge to strike a hospital survey from a friend-of-the court brief filed by 340B healthcare providers. [ms-protect-content id="2799"] The brief was filed late last month in support of a Department of Health and Human Services [HHS] rule that allows certain hospitals to receive discounted pricing on “orphan” drugs when not used to treat rare … [Read more...]