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Pharmacies Getting Caught by Surprise with Audit Over Mailing into States In Which They Are Not Licensed or Registered as an Out-of-State Pharmacy

In recent months, we have seen a new audit focus emerge among various pharmacy benefits managers (PBMs) that is catching pharmacies by surprise and resulting in large recoupments and even network termination. It starts with a PBM requesting, in the course of an audit, copies of the pharmacy’s State pharmacy licenses. Thereafter, the PBM compares the States into which a pharmacy has mailed medications with the States in which the...

ESI/Medco Appear to be Reviving Compound Pharmacy Audit Trends Relating to Purchase History “Investigation”

In a resurgence of the previous audit trends, ESI and Medco appear to be reviving the practice of investigating compounding pharmacies for fraud, waste and abuse through purchase history verifications. While termed an “investigation,” ESI/Medco are essentially conducting what appears to be a run-of-the-mill audit, focusing on a purchase history verification. With similar “investigations” in the past, ESI/Medco have attempted to argue that a pharmacy is committing fraud by billing full...

Senate Goes Into Recess Without Vote on Pharmacy Compounding Quality and Accountability Act

While Senators Lamar Alexander (R-TN) and Tom Harkin (D-IA) of the HELP Committee have pushed to fast track the Pharmacy Compounding Quality and Accountability Act (S. 959) and there had been discussions of a swift vote, those aspirations will be delayed for additional time, as the U.S. Senate has gone into its August recess without a vote on this measure, or a recently introduced track-and-trace measure. This delay is likely...

Pharmacy Compounding Quality and Accountability Act Unlikely to See Swift Passage

While Senators Lamar Alexander (R-TN) and Tom Harkin (D-IA) of the HELP Committee are pushing to fast track the Pharmacy Compounding Quality and Accountability Act (S. 959) and are hoping for a swift vote, recent actions by Sen. Tom Coburn (R-OK) calling for more review of the measure make it unlikely that the bill will be passed before the August recess. PCQAA is the Senate’s response to the NECC incident,...

Sterile Compounder Agrees to Cease Operations in Consent Decree with FDA, Highlighting Need for FDA Inspection Standard Operating Procedures

A New Jersey-based sterile compounding pharmacy recently entered into a Consent Decree with the Food and Drug Administration (FDA) following an investigation by the Agency in which the pharmacy was cited for unsanitary conditions and violations of good manufacturing practice requirements.  The pharmacy was also cited for producing and distributing numerous drug products without receiving patient-specific prescriptions and without having an approved new drug application or approved abbreviated new drug...