Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the DOJ and OIG bringing a number of fraud cases against pharmacies and pharmacists. Although many enforcement actions under the False Claims Act (FCA) continue to focus on illegal kickback arrangements, this summer we saw an increased focus on enforcement resulting from over-prescribing of opioids and Controlled Substances Act (CSA) violations. We also saw enforcement against pharmacies for allegedly falsifying prior authorization information and providing more insulin than the pharmacy billed to payors. This blog summarizes some of these and other key pharmacy enforcement trends this summer.

PillPack Insulin Overdispensing Settlement

The summer began with online retail pharmacy PillPack, LLC reaching a settlement of $5.79M on May 2nd with the United States Attorney's Office for the Southern District of New York and OIG (collectively, the Government) regarding the under-reporting of days-of-supply of insulin pens that led to fraudulent billing of government healthcare programs.

According to the Stipulation of Settlement, PillPack fraudulently reported lower days-of-supplies of insulin than it was actually dispensing to patients. This alleged underreporting often led to PillPack pharmacists dispensing insulin pen refills to patients earlier than was...

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