January 11, 2013
The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs has been instructed by the Government Accountability Office to conduct both random and targeted audits within the 340B Drug Pricing Program. Often referred to as a 340B integrity audit, these reviews are conducted to provide additional program oversight, monitor for program violations and prevent diversion and duplicate discounts. The HRSA has already begun to conduct the integrity audits, with the initial random audits targeting covered entities with potentially higher program risk due to their volume of drug purchases, the level of program administration complexity and their use of contract pharmacies.
As the HRSA continues to conduct targeted audits, hospitals and health
systems contemplate what the audit could mean for them. Below are three key
steps hospitals and healthcare providers can take to prepare for a 340B Drug
Pricing Program integrity audit.
Review of these four areas will help to evaluate the overall audit preparedness for a hospital or health system and could identify additional areas for further, more intensive review.
Overall, hospitals and health systems should prepare for a 340B integrity audit by ensuring before an audit takes place that individual practices and procedures are in compliance with program standards. For more information about steps to take in preparing for an integrity audit, please contact one of the authors.