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Good News for Distributors and Manufacturers: Court Holds Municipalities to Higher Pleading Standards in Lawsuits in Comparison to Claims Brought by States and the Federal Government

With lawsuits brought by municipalities against opioid manufacturers and distributors exploding across the country in nearly every state, a recent court ruling gives municipalities pause, providing both relief and clarity to the industry. Last week, the Superior Court in the Judicial District of Hartford dismissed a suit brought by Connecticut municipalities against opioid manufacturers and distributors (including Purdue Pharma, L.P., Teva Pharmaceuticals USA, Inc., Johnson & Johnson, McKesson Corporation, Cardinal...

The District of New Jersey’s Creative Charging Greatly Increasing Physician Criminal Exposure

When dealing with white collar crime and fraud, federal sentencing guidelines largely reflect the amount of loss sustained. When it comes to the federal Anti-Kickback Statute (AKS)- which makes it a crime to seek, offer, give or receive any remuneration in exchange for the referral of a health care service- the loss is the amount of reimbursement from a federal healthcare program (Medicare, Medicaid, Tricare, etc.) for any service during...

Frier Levitt Succeeds in Challenging PBM Audit Based on Services Inadvertently Billed to Deceased Patients

Frier Levitt recently assisted an independent pharmacy with a PBM audit in which the Pharmacy Benefit Manager (PBM) alleged that the pharmacy had billed several claims to four beneficiaries who were deceased on the date of service for the claim. The PBM advised that if the pharmacy did not demonstrate the appropriate billing of those prescriptions, the claims would be reversed, and the full amount previously paid on each of...

Government Tries to Reframe Materiality in False Claims Act: What It Means for Providers

As the overseer of health benefits for millions of Americans, the Federal Government has a vested interest in ensuring the legitimacy of claims submitted for payment to Government Healthcare programs, such as Medicare, Medicaid, and Tricare. The False Claims Act (the "FCA" or the "Act"), which is perhaps the Government's strongest tool in ensuring the validity of claims, is a civil statute which carries harsh penalties for knowingly submitting, or...

Government Investigations: When Not Responding is a Non-Option

It is not uncommon for multiple, or even parallel, investigations into the same provider to take place concomitantly. To be sure, oftentimes, a pharmacy or physician practice is served with a government's investigative demand for documents or testimony only to be served with another demand by a different investigating agency or governmental body shortly thereafter. These investigations can be criminal, civil, or administrative in nature.  A recent case out of...