What type of records must be maintained for compliance and audit purposes?

Maintaining thorough documentation is essential for compliance and audit purposes within the 340B program. Documentation encompasses a wide range of records that demonstrate adherence to program requirements, including records related to drug purchases, inventory management, patient eligibility, and claims processing. This type of documentation supports transparency and accountability, which are crucial elements in ensuring that covered entities are operating within the legal framework of the 340B program.

Proper documentation also provides evidence during audits conducted by the Health Resources and Services Administration (HRSA) or other regulatory bodies, ensuring that entities can show they are following all necessary guidelines and regulations. Comprehensive records not only help in verifying that discounts are being applied correctly but also protect organizations from potential penalties or loss of program eligibility.

While patient satisfaction surveys, employee training logs, and marketing materials may all hold valuable information regarding the general operations of a healthcare organization, they do not directly pertain to the requirements for compliance and auditing focused on the 340B program. Thus, they do not fulfill the specific record-keeping obligations that the 340B program mandates.