Infusion providers are highly regulated. They must comply with the requirements of State Boards of Pharmacy, the FDA, the DEA, PBMs and other third-party payors. Responding to DEA and PBM investigations and audits can be particularly challenging. The DEA (i) has an army of attorneys, accountants, and consultants at its disposal and (ii) can shut an infusion provider out of the controlled substance space. PBMs present a different challenge. Under the heading of “Possession is 9/10ths of the Law,” PBMs possess the provider’s money. A PBM can withhold payments to an infusion provider while the PBM determines, rightfully or wrongfully, whether the provider is adhering to PBM requirements. And the PBM has the nuclear option of terminating its contract with the infusion provider. It is almost certain that an infusion provider will have to respond to a DEA and/or PBM investigation/audit at some point during the provider’s existence. This program will discuss the “hot button” issues that the DEA and PBMs are looking at. The program will further discuss the steps an infusion provider can take to (i) reduce the risk of being subjected to a DEA and/or PBM audit/investigation, (ii) prepare for an investigation/audit, and (iii) successfully respond to and resolve a DEA and/or PBM investigation/audit. Specific issues to be addressed include (i) implementation of a robust compliance program, (ii) organization of information and documents to be submitted to the DEA/PBM, (iii) how to pivot the investigation/audit into a “win-win” scenario, and (iv) how to structure a settlement.