Pharmacy Law

/Pharmacy Law

Labs and Physicians Drawing Government Scrutiny and Private Lawsuits

Last week the U.S. Attorney’s Office for the Northern District of West Virginia settled kickback allegations against Dr. Brenna Green, a Murfreesboro, Tennessee, osteopath for her role in a multi-state fraudulent investment scheme that the feds say involves a number of physicians and several laboratories. Green has paid nearly $200,000 as settlement of allegations that [...]

Jazz Pharmaceuticals Reveals $57 Million Set Aside in SEC Filing

Funds designated for resolution of DOJ investigation into Patient Assistant Program donations In January, we noted that the new U.S. Attorney in Massachusetts, Andrew Lelling, had publicly stated that he plans to keep the pressure on drug makers and patient assistance charities that are involved in “crooked” donations – see “Massachusetts’ New U.S. Attorney Vows [...]

Florida Compounding Pharmacy Fraud Conspirator Sentenced

Last fall we issued a client alert, “Medicare Fraud Strike Force Nabs Eight in $100 Million Compounding Scheme” where we reported on Nicholas A. Borgesano, Jr., who, with his fellow conspirators, plead guilty to defrauding Medicare and Tricare in a bribery and kickback scheme that netted them over $100 million in proceeds. On April 26, [...]

Client Alert – Radiation Therapy Clinic Settles Kickback Allegations for $11.5 Million

In a settlement announced late last week by the U.S. Attorney for the Northern District of Texas, radiation therapy center operator SightLine Health LLC (SightLine), Integrated Oncology Network Holdings LLC (ION), which acquired SightLine in 2011, and a number of leasing and holding companies agreed to pay up to $11.5 million to resolve allegations that [...]

Client Alert – FDA Issues Draft Guidance on Bulk Compound Drug Substances

In January of this year, and in response to concerns over the risks associated with the use of non-FDA approved, compounded drugs (particularly in the wake of the 2012 fungal meningitis outbreak that began with contaminated compounded injectable drugs), the U.S. Department of Health and Human Services Food and Drug Administration (FDA) issued a compounding [...]

Client Alert – Nationwide Dialysis Provider Settles Patient Privacy Breach Allegations for $3.5 Million

Late last week, Fresenius Medical Care (FMC), a dialysis provider with nationwide coverage that also operates a number of urgent care centers and labs, settled with the Department of Health and Human Services Office of Civil Rights (OCR) over a number of alleged patient privacy breaches that occurred in 2012. In addition to a payment [...]

Client Alert – Massachusetts’ New U.S. Attorney Vows to Continue Pressure on Drug Makers and Patient Assistance Programs

Readers may recall our alert from November 2017, “Patient Assistance Charity Loses Protection from Kickback Liability - Office of Inspector General Revokes Advisory Opinion” in which we relayed the story of Caring Voice Coalition (CVC), a patient assistance program formed to help patients afford expensive prescription drugs by funding health insurance copayments. CVC, like many [...]

Pharmaceutical Sales Rep Gets 65-Month Sentence in Fraud Scheme

Kirtis Green, a sales representative for Tennessee company Top Tier Medical, earned a 65 – month prison stint for his role in a $5 million health care fraud that saw several private health insurance companies, together with TriCare, duped into paying for medically unnecessary compounded creams. The charges against Green included Wire, Mail, and Health [...]

Client Alert – 2017 False Claims Act Enforcement Recovers $3.7 Billion

No Signs of a Slow Down in 2018 The 2017 fiscal year-end results are in and the U.S. Department of Justice (DOJ) has announced the recovery of $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government. In a summary of 2017 enforcement activity, the DOJ year-end report [...]

Federal Prosecutors Given Green Light to Enforce Marijuana Laws following Long Hiatus under Obama Administration

The de facto federal safe harbor for the nation’s burgeoning marijuana industry may be coming to an end with the release yesterday of a memorandum from U.S. Attorney General Jeff Sessions notifying the nation’s 93 U.S. attorneys that prior Department of Justice guidance specific to marijuana enforcement had been rescinded.[i] The prior guidance documents, often [...]