December 2, 2010—The leaders of a bipartisan deficit reduction commission appointed by President Obama released a final plan yesterday calling for major changes in federal health policy and tight limits on federal health spending. The 18-member National Commission on Fiscal Responsibility and Reform will vote on the plan Dec. 3. The report, entitled "The Moment of Truth," … [Read more...]
AIDS Group Sues BMS for Retroactive 340B Discounts
Says price reductions due to health care reform extend back to the beginning to 2010.December 2, 2010—The AIDS Healthcare Foundation (AHF) has sued Bristol-Meyers Squibb (BMS) to recover the $124,000 it estimates it overpaid for 340B-discounted drugs during the first half of 2010 due to what it claims was the company's delay in reducing its prices as required by health care reform. The suit, filed Nov. 24 in federal district court in Los Angeles, asserts … [Read more...]
Impax Laboratories to Provide $525,000 in 340B Refunds
Repayments cover purchases from late 2007 through early 2010.November 24, 2010—Impax Laboratories will be providing more than 1,600 340B covered entities with a total of $525,000 in refunds for overcharges from the third quarter of 2007 through the first quarter of 2010 for products bearing labeler code 00115, the Office of Pharmacy Affairs (OPA) announced on its Web site yesterday. According to OPA, when the company recalculated its … [Read more...]
Providers Comment on Two 340B Program Integrity Rulemaking Notices
Submissions address forthcoming rules on dispute resolution and fines for overcharges.November 24, 2010—340B providers that lodge overcharging claims against drug companies under a new mandatory dispute resolution process should get access to the data and methods the companies use to set their average manufacturer prices (AMPs) and best prices (BPs), groups representing hospitals and clinics in the drug discount program urged in comments filed with the Office of … [Read more...]
Groups Demand Immediate Resumption of 340B Orphan Drug Sales
Firms' decisions to deny hospitals discounts were unwarranted and premature, letters assert.November 23, 2010—Organizations representing a broad spectrum of hospitals have called upon drug companies that are denying 340 discounts on orphan drugs to immediately resume selling the pharmaceuticals at discounted prices. During the past few months, at least six manufacturers have informed children's hospitals and rural and cancer hospitals newly enrolled in 340B that … [Read more...]
First Shots Fired in 340B Case Before the U.S. Supreme Court
Firms, trade groups and U.S. government urge reversal of ruling recognizing right to sue.November 23, 2010—Thirteen leading pharmaceutical manufacturers, two trade associations and the federal government are urging the U.S. Supreme Court to overturn a federal appellate court ruling recognizing 340B providers' right to sue drug companies for alleged overcharges. In papers filed with the High Court in Astra v. Santa Clara (Case No. 09-1273), the companies, the … [Read more...]
CMS Withdraws Rules Calculating Key Component of 340B and Rebate Prices
Says it expects to issue follow-up regulations implementing health care reform changes.November 17, 2010—The Centers for Medicare and Medicaid Services (CMS) published a final rule this week withdrawing its regulations and guidelines for determining the average manufacturer price (AMP) of prescription drugs subject to Medicaid rebates and 340B discounts. CMS initially announced the withdrawal in a proposed rule published in the Sept. 3Federal Register. AMP is the … [Read more...]