Last week, federal health officials published a final rule for the 340B drug discount program that enables rural hospitals to continue stretching their dollars, serving more patients, and improving their services. The July 23 regulation by the Health Resources and Services Administration (HRSA) implements statutory language that limited 340B drug discounts on orphan drugs for … [Read more...]
HRSA Publishes Final 340B Orphan Drug Regulation
Rule Goes Into Effect October 1st, 2013Earlier today, HRSA published online its long-awaited final regulation to implement the 340B “orphan drug exclusion,” which limits 340B-purchasing for free-standing cancer hospitals, critical access hospitals, sole community hospitals, and rural referral centers participating in the 340B drug discount program. The final regulation mirrors HRSA’s May 2011 proposed rulemaking in … [Read more...]
White House Budget Office Clears 340B Orphan Drug Rule for Publication
Also, details emerge about HRSA's comprehensive 340B regulationJuly 17, 2013—The White House Office of Management and Budget (OMB) has finished its review of the long-awaited final regulation to implement health care reform’s partial limit on 340B discounts for orphan drugs, presumably clearing the rule for publication in the Federal Register.[ms-protect-content id="2799"] OMB completed the review on July 12. It said the regulation was … [Read more...]
HRSA Releases 16 More 340B Provider Audit Findings
First-ever audit of a drug manufacturer may be drawing near, official saysJuly 17, 2013—The Health Resources and Services Administration (HRSA) has released 16 more summaries of the findings from its audits of 340B covered entities in 2012.[ms-protect-content id="2799"] HRSA posted the findings on its website late last week. That brings the total number of audit findings released to 34, out of 51 audits conducted last year. Yesterday during the … [Read more...]
340B Coalition Honors Senator Harkin
Veteran Iowa lawmaker receives group's lifetime achievement awardJuly 16, 2013— Senator Tom Harkin (D-Iowa) received the 340B Coalition's Lifetime Achievement Award yesterday during a ceremony opening the group's 17th Annual Conference, held in Washington, D.C. The coalition represents safety-net health care providers that participate in the 340B drug discount program.[ms-protect-content id="2799"] Senator Harkin, who chairs both the … [Read more...]
Senate Appropriators Say 340B Is Not Just an “Individual Discount”
Committee's report language supports providers' position in debate over program's purposeJuly 15, 2013—The full Senate Appropriations Committee has strongly reaffirmed that the 340B program is "more than simply an individual discount program" in report language accompanying its fiscal 2014 spending bill for labor, health, and education programs.[ms-protect-content id="2799"] In the companion report to the spending bill, the panel said "the 340B program was … [Read more...]
Senator Grassley, PhRMA Respond to 340B Hospitals’ Report
Lawmaker says study isn't "objective" while drugmakers raise doubts about program in its "current form"July 12, 2013—The Senate Republican who has been examining hospitals' participation in the 340B program and the trade association for brand-name drug manufacturers have responded to a major new report on the 340B drug discount program.[ms-protect-content id="2799"] In a July 9 news release, Sen. Charles Grassley (R-Iowa) said the report on 340B that Safety Net Hospitals for … [Read more...]