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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...]

Medicaid Advisory Group Expresses Interest in 340B Shared Savings Arrangements

Policy option bears closer inspection, member suggests during meeting. 

November 12, 2010—A member of a new federal commission that will be advising Congress on Medicaid access and payment policies has suggested that it look into how state Medicaid programs might share 340B savings with safety-net providers enrolled in the outpatient drug discount program. Richard Chambers, the chief executive of a California managed care organization (MCO) and … [Read more...]

HRSA Patient Safety Teams Receive Awards

Groups have been working to reduce medication errors and improve patient outcomes. 

November 11, 2010—The Health Resources and Services Administration (HRSA) has bestowed awards on multiple health care teams across the country for their achievements in the agency's Patient Safety and Clinical Pharmacy Services Collaborative (PSPC). Now in its third year, PSPC's mission is to improve health care outcomes by integrating evidence-based clinical pharmacy … [Read more...]

CMS OK’s Maine’s Method of Billing Medicaid for Physician-Administered Drugs

Federal approval could pave the way for model's adoption by other states. 

November 10, 2010—Federal health officials have given Maine's Medicaid agency the go-ahead to exempt all but a handful of the state's hospitals from reporting National Drug Codes (NDCs) for physician-administered outpatient drugs. Under the arrangement, none of the state's 340B hospitals is required to change billing and payment for such drugs. The decision, which the … [Read more...]

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