A New York-based pharmacy was facing a $400k recoupment following a PBM invoice reconciliation audit where the PBM had alleged the pharmacy did not have proper inventory. This is not an uncommon occurrence as PBMs often conduct invoice reconciliation audits to compare quantities of medications and the quantities billed. After submitting invoice documentation and other supporting materials, Frier Levitt successfully demonstrated that the pharmacy had maintained sufficient inventory at all...
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...
In an alarming trend, representatives of the DEA, investigators who bring matters before the New Jersey State Board of Medical Examiners, and local police have been combining their efforts together to make unscheduled, surprise visits to several New Jersey medical practices. The purpose of the visits ostensibly has been to conduct an inspection or execute a search warrant. However, during the visit there has been extensive questioning, even interrogation, that...
In a major development in the pharmaceutical industry, the FDA recently announced that it is withdrawing a proposed rule requiring generic drug manufacturers to independently update their drug labels with new information. Currently, generic manufacturers who hold Abbreviated New Drug Application (ANDA) are prohibited from making unilateral changes to their label prior to the corresponding branded Referenced Listed Drug (RLD) manufacturers make changes in the brand drug label. The proposed...
Too often, pharmacies are faced with the difficult proposition of seeking admission into Medicare Part D networks. With new and evolving pharmacy business models, along with ever-changing and contracting pharmacy networks, it can be challenging to determine the appropriate network(s) to seek access to. This can be further complicated by PBMs routinely seeking to push pharmacies into general "retail pharmacy" networks, while restricting access from networks that provide more opportunity...
