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The Continued Scrutiny of Opioids: What Physicians and Pharmacists Need to Know

The war on opioids continues unabated, most recently with the Appalachian Regional Prescription Opioid Strike Force conducting another roundup. The roundup, which included the execution of search warrants, involved the charging of 60 people, including 53 medical professionals, with illegally prescribing controlled substances, which further supports the growing sentiment that the indiscriminate prescribing of opioids is the current hot-button item in medicine. The basic standard applied by authorities to individuals...

DOJ Position on Off-Label Promotion: What’s Changed and What’s the Same

It is well known that the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device or drug manufacturer who promotes any unapproved uses of FDA-approved devices/drugs is in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA has asserted that off-label promotion leads to misbranding of the product and circumvention of the regulatory approval process that is taken to ensure product...

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...