For many years, drug manufacturers and covered entities participated in the 340B Program with little oversight. However, amid concerns of excessive pricing, diversion and other abuses of the 340B Program, and at the recommendation of the Government Accountability Office (GAO), the Health Resources and Services Administration (HRSA) has recently increased its regulatory oversight of covered entities. Additionally, the expansion of the contract pharmacy network for many covered entities is gaining the attention of the Office of Inspector General (OIG) and HRSA.


Is Your Organization Prepared to Demonstrate Active Compliance with the 340B Program?

Given HRSA’s increase in 340B oversight activities, covered entities must demonstrate that their programs have been independently and objectively assessed. With over 30 years of experience in advising healthcare clients, PYA has assisted covered entities in multiple areas of 340B compliance. PYA’s services meet HRSA’s recommendation for independent audit(s).

View Hospital Self-Assessment Checklist

View Clinic Self-Assessment Checklist

  • Annual Independent Audits
  • 340B Program Compliance Infrastructure
  • Roles and Responsibilities
  • Policy and Procedure Development and Testing
  • Covered Entity Eligibility
  • Eligible Patient and Prescriber Definitions
  • Split Billing Software Edits
  • Mock “HRSA Audit Readiness” Reviews
  • Design of Internal Audit Work Plans
  • Periodic Compliance Testing
  • Education and Training for Governance and Management
  • Reimbursement and Cost Reporting


PYA is well-versed in the complex regulatory environment of the healthcare industry. As such, we have a unique understanding of the issues surrounding 340B compliance. If you are uncertain whether you are in compliance with the 340B Program, contact us about an assessment. At the conclusion of the assessment, we can advise you on the areas that may need additional attention.