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»  Posts By   August 2015 

The Government Accountability Office Publishes Data Claiming 340B Has Created Too Many Financial Incentives

The United States Government Accountability Office (GAO) published a troublesome recommendation in its recent report to Congress on Medicare Part B Drugs. In the June 2015 report, published on July 6, 2015, the GAO suggested that “Congress should consider eliminating the incentive to prescribe more drugs or more expensive drugs than necessary to treat Medicare Part B beneficiaries at 340B hospitals.” The recommendation comes as a result of the GAO...

Arkansas Law Creates a New Tool to Fight PBM Drug Payments That Fall Below Acquisition Cost

Arkansas recently enacted a new law favoring independent pharmacies in filling prescriptions through insurance companies and Pharmacy Benefit Managers (PBMs). The law – which became effective on July 22, 2015 – requires transparency of Maximum Allowable Costs (MAC) and requires PBMs to make its MAC lists available for regular publication. With respect to pharmacies, the law requires an administrative appeal procedure for Arkansas pharmacies to challenge MAC pricing for any...

Legal Implications of Compounding for Veterinary Use

Veterinary compounding is a growing market, and ranges from simply flavoring medications to customized cancer prescriptions. It also introduces a distinct set of legal issues, as while some practices are covered by existing laws governing human compounding, others fall into grey areas, in which no clear guidance is apparent. One of these issues is that of compounding for “office use” - in which a medication is compounded and sold to...

Medical Device Manufacturer NuVasive Inc. to Pay $13.5 Million to Settle False Claims Act Allegations

On Thursday, July 30, 2015 the Department of Justice (DOJ) announced that medical device manufacturer NuVasive Inc. had agreed to pay the United States $13.5 million to resolve allegations the Company was involved in causing healthcare providers, including physicians, to submit false claims to Medicare and other federal health care programs (see United States ex rel. Kevin Ryan v. NuVasive, Inc. (D. Md.)). The Government’s allegations focused on the Company’s...

Recent Ruling Supporting Free Speech in Off-Label Drug Promotion May Have Impact on Compounding Pharmacies and Their Marketing Practices

Last week, a New York Federal judge ruled that Amarin Pharma Inc. has a constitutional right - and is protected from interference by the FDA - to make certain truthful and nonmisleading statements about off-label uses of its product, Vascepa. In the lawsuit, Amarin Pharma sought an injunction against the FDA to prevent enforcement of rules that would otherwise prohibit the communication to physicians or other healthcare providers of truthful...
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