Recently, Pharmacy Benefit Managers (PBMs) have been requesting pharmacies to provide documentation in compliance with Drug Supply Chain and Security Act (DSCSA), better known as “track-and-trace.” DSCSA was enacted as part of the Drug Quality and Security Act of 2013 and outlines steps for the drug chain participants to implement a system that tracks a drug at the unit-level throughout the drug supply chain. At this juncture, the United States Food and Drug Administration (FDA) is only requiring participants to develop a system that provides lot-level traceability and verification of product and transactions. By 2023, drug chain participants must be able to provide and maintain unit-level traceability data.
The track and trace documentation has not been a part of PBMs’ routine invoice reconciliation audits whereby PBMs compare quantities of medications and the quantities billed. However, this has changed recently. Now, PBMs have begun requesting track and trace documents even after the pharmacy having provided invoice documentation and other supporting materials that otherwise validate its purchases. Pharmacies are being asked provide transaction history, transaction information, and transaction statement, and to maintain such records for not less than six years after the transaction. Specifically, the transaction information includes:
- The proprietary or established name or names of the product
- Strength and dosage form of the product
- National Drug Code number of the product
- Container size
- Number of containers
- Lot number of the product
- Date of the transaction
- Date of the shipment (if more than 24 hours after the date of the transaction)
- Business name and address of the person from whom ownership is being transferred
- Business name and address of the person to whom ownership is being transferred
Pharmacies are expected to ensure that wholesalers provide the aforementioned information at the time of purchase or be in a position to provide this information at the time of a request. Such requests are being made despite pharmacies having purchased from duly, licensed, and verifiable wholesalers. The inability to provide complete and accurate information has been the basis of large recoupments and additional adverse action against pharmacies.
Furthermore, PBMs keep track of their network pharmacies’ audit histories and are using prior audit results in order to form the basis of termination. It is critical to challenge any and all discrepancies raised in PBM audits even if such audit does not result in adverse reaction beyond the recoupment of monies from the pharmacies. Frier Levitt works with pharmacies regarding PBM audit findings and other PBM-related issues, including contract documents and other abusive PBM practices to which pharmacies are frequently subjected. Frier Levitt also works wholesalers and manufacturers to ensure compliance with track-and-trace requirements. Contact Frier Levitt today to speak to an attorney.