May 23, 2013—The manufacturer of the only FDA-approved orphan drug for children with a rare hormone deficiency that causes short stature is limiting purchases due to an imminent halt in production. The Office of Pharmacy Affairs (OPA) posted the notice by Ipsen Biopharmaceuticals, the maker of the drug Increlex, on its website's home page on May 22. … [Read more...]

May 17, 2013—About 25 million Americans will gain health coverage by 2023 under the Affordable Care Act (ACA) but about 31 million will remain without insurance, according to new projections from the nonpartisan Congressional Budget Office (CBO). The health coverage figures were included in CBO's latest federal budget projections for the coming decade. … [Read more...]

May 16, 2013—The long-awaited regulation to implement health care reform's partial limit on 340B discounts for orphan drugs is back on hold. On May 8, the White House Office of Management and Budget (OMB) reported online that its review of the Health Resources and Services Administration's (HRSA) proposed 340B orphan drug exclusion final rule had been extended. … [Read more...]

May 15, 2013—Drug manufacturer Mylan has mailed refunds to 340B providers for overcharges on all products sold by its Mylan Specialty subsidiary (formerly known as Dey Pharma) from late 1994 through late 2006. Last November, the Office of Pharmacy Affairs (OPA) posted a message from Mylan on its home page explaining that the company needed to give refunds to 340B entities … [Read more...]

May 7, 2013—A federal district judge has ordered California to stop requiring 340B health care providers to "carve in" all Medicaid patients and to bill the state for 340B drugs given to such patients at actual acquisition cost (AAC). Acting in a case brought by the AIDS Healthcare Foundation (AHF), U.S. District Judge Manuel L. Real issued a permanent injunction on May 3 … [Read more...]

May 6, 2013—The Illinois Department of Healthcare and Family Services has reversed a decision it made earlier this year to require 340B contract pharmacies to use 340B drugs for Medicaid patients beginning this July. In a recent statement on its website, the department said it was putting the requirement on indefinite hold. "In the contract pharmacy scenario, the pharmacy … [Read more...]

May 2, 2013—The Health Resources and Services Administration (HRSA) "is continuing to work" with the White House Office of Management and Budget (OMB) on a final regulation to implement the Affordable Care Act’s (ACA) restriction on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under health care reform, a HRSA spokesperson said this … [Read more...]