Travis Leonardi has over a decade of experience in healthcare, pharmaceuticals, and information technology. He has knowledge of pharmaceutical auditing processes, including those that apply to the Health Resources and Services Administration 340B Drug Pricing Program, which allows eligible healthcare organizations to purchase drugs at reduced prices to provide comprehensive care to underserved patients. Organizations must register for the 340B program and undergo regular audits to ensure compliance with guidelines regarding duplicate discounts, prohibitions, and group purchasing. The audits involve reviewing documentation, operations, and drug transaction records and result in a report drafted by the Office of Pharmacy Affairs detailing any necessary corrective actions.

1. By Travis Leonardi

2.  Florida resident Travis Leonardi, founder of Sentry
Data Systems, Inc., has more than a decade of
experience in health care, pharmaceuticals, and
information technology. Throughout his career,
Travis Leonardi has gained knowledge in
pharmaceutical auditing processes, which applies to
areas such as the Health Resources and Services
Administration (HRSA) 340B Drug Pricing Program.
The HRSA 340B Drug Pricing Program makes it
possible for eligible health care organizations to
procure outpatient drugs directly from manufacturers
at a reduced price, therefore extending
comprehensive care to patients who would not
otherwise have access to these medications.

3.  Organizations and other health care entities must
register to be considered for the 340B program and
follow strict guidelines to maintain eligibility.
Participants must uphold the integrity of 340B and
agree to undergo regular audits, which are conducted
by manufacturers or the federal government. Audits
involve the review of duplicate discounts, prohibition,
and compliance with the Group Purchasing
Organization. Prior to the audit, the company receives
a notification letter explaining and discussing how to
prepare for the inspection. A teleconference between
HRSA regional auditors and the entity then takes
place to identify necessary paperwork for review.

4.  On the day of the audit, the auditor reviews
340B program data and internal controls. In
addition, the process involves inspection of
operations and testing of 340B drug
transaction records. All collected data and
facts are then reported to the Office of
Pharmacy Affairs, which drafts a final report
and a corrective action plan, if needed.