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»  Posts By   December 2016 

OIG Issues Final Rule Revising and Introducing New Safe Harbors Under the Anti-Kickback Statute

In 2014, the Department of Health and Human Services' (HHS) Office of Inspector General (OIG) first announced modifications to existing federal Anti-Kickback Statute (AKS) safe harbors and the beneficiary inducement prohibition in the Civil Monetary Penalty rules (CMP Law). The OIG published a final rule on December 7, 2016. The Final Rule becomes effective on January 6, 2017. Revisions to Anti-Kickback Statute Safe Harbors The modifications would codify statutory changes...

Generic Drug Companies Accused of Price Fixing in 20 States

In a civil complaint filed December 15, 2016, 20 State Attorneys General accused six generic drug companies, including Teva Pharmaceuticals and Mylan, of engaging in price-fixing schemes. The complaint alleges that the companies conspired to artificially inflate the prices of the antibiotic drug, doxycycline hyclate, and the diabetes drug, glyburide. The complaint asserts that these competing manufacturers' executives engaged in price fixing by agreeing on how much market share or to...

Court Strengthens “Public Disclosure Bar” in Dismissing Whistleblower Lawsuit Against PharMerica: Good for Providers

Last month, a federal district court dismissed a False Claims Act (FCA) qui tam action that was brought against PharMerica by a whistleblower. The suit claimed that PharMerica, the nation's second largest long-term care pharmacy, had engaged in an illegal "swapping" arrangement with nursing homes to ensure prescription referrals for its Medicare Part-D patients. The whistleblower, Marc Silver, claimed that he discovered the alleged swapping arrangement by examining publicly available...

PBMs Wrongfully Increase Scrutiny of Pharmacies Due to “Gray Market” Diabetic Test Strip Suppliers

In the wake of the recent litigation involving Abbott Laboratories and "gray market" diabetic test strips, pharmacies are facing increased PBM scrutiny over their purchases from certain pharmaceutical distributors, including secondary wholesalers. On November 4, 2015, Abbott Laboratories won a court order barring certain pharmacies and distributors from selling what it claimed to be "gray market" versions of its diabetes test strips in the United States. In the litigation, Abbott...

Hospital HIPAA Breach Highlights the Value of a Thorough Risk Assessment

Recently, a university hospital reached a settlement of potential violations of the Health Insurance Portability and Accountability Act (HIPAA) following an investigation of a breach of unsecured Protected Health Information (PHI). PHI of nearly 1,700 individuals was impermissibly disclosed when the hospital's network was attacked by a malware virus; the hospital did not have an acceptable firewall in place. In accordance with HIPAA regulations, the hospital disclosed the breach in...
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