Although independent pharmacies have typically been the targets of PBM audits, recently, PBMs have been setting their sights on other dispensing entities, including those which, before now, have not received substantial audits, such as community oncology practices. While the exact structure and operations of these practices can vary, generally speaking, community oncology practices are private physician-based practices where patients can receive cancer treatments. Community oncology practices provide an alternative to hospital-based cancer treatment, specifically by allowing patients to have their medications administered directly in their physician’s offices. The convenience and overall comfort provided in these settings as opposed to hospitals are one of the many reasons that patients may elect to be treated in community oncology practices. As more and more cancer treatments and therapies have migrated from intravenous-based chemotherapy administered in physicians’ offices to oral oncolytics that are self-administered by the patients, many community oncology practices have added some form of in-office dispensing to provide outpatient oncology medications directly to their patients. The exact form of this in-office dispensing may vary depending on state law, with some community oncology practices engaging in physician dispensing under the prescriber’s plenary medical license, while other practices own and operate licensed pharmacies housed directly within the practice.
Despite the fact that community oncology practices have been engaged in the dispensing of prescription drug products for some time, until recently they have not been subject to PBM audits (at least to the rates seen by independent retail pharmacies). Frier Levitt attorneys have noticed a distinct uptick in the number of audits being performed on community oncology practices, with a noted majority of these audits being conducted by a single major PBM. While the targeting of these entities is atypical compared to audit trends in recent years, the types of discrepancies and conduct at issue in these audits are typical of what is seen in PBM audits of pharmacies. In particular, PBMs have required community oncology practices to submit documentation to prove that the practices are collecting the appropriate copayments from patients, and that the prescriptions are being dispensed and billed in accordance with the directions and days supply authorized by the prescriber. We have also seen specific audits focusing on the dispensing of certain oncology medications, like Venclexta, in accordance with the FDA-approved labeling and manufacturer instructions. Upon receipt of audit findings, community oncology practices should remember to fully exhaust all appeals processes afforded to them under their PBM provider agreement and utilize the same strategies Frier Levitt has previously discussed in order to resolve discrepancies alleged by PBMs.
As we have previously discussed, one of the strongest strategies that pharmacies can use to combat PBM audits is establish and maintain an organized recordkeeping system, as a majority of the kinds of discrepancies that are most commonly alleged by PBMs are easily resolved by the submission of clear documentation that substantiates pharmacies’ position that the prescriptions were dispensed in accordance with the terms and conditions of their provider manuals. Likewise, community oncology practices should be sure to maintain clear records of the copayments collected, and the manner in which the prescriptions are dispensed or administered to their patients in the event that the collections of copayment or authorization of the underlying prescriptions are challenged.
How Frier Levitt Can Help
If you are a physician whose community oncology practice has recently underwent an audit or received audit findings, or wants to make sure they are adequately prepared in the event that they receive an audit request, Frier Levitt can help. Contact us to speak with an attorney today.
