340B Drug Pricing Program
The 340B drug pricing program, created through the Veterans Health Care Act of 1992, requires drug manufacturers to provide discounted outpatient drugs to covered entities, allowing them to stretch scarce federal resources, reach more eligible patients and provide more comprehensive services.
BKD assists 340B-covered entities with the program’s various aspects. Our national 340B team has technical skills to help provide quality compliance services, best practices and tailored insight. We understand the financial demands facing health care providers and can help offer practical compliance and operational recommendations that go beyond the basic service approach.
- Independent 340B Audits
- BKD performs independent external 340B audits for covered entities throughout the country that are expected to conduct such audits. Our process helps review multiple aspects of 340B, from policies and procedures to eligible dispensations. These procedures are designed as a mock audit that simulates a Health Resources and Services Administration (HRSA) audit. It’s increasingly important to have accurate, complete and auditable records to maintain compliance and identify the program’s key risks. Our process helps identify additional program opportunities and risks while helping entities create precise and compliant audit trails.
- Operational Services
- BKD’s 340B team has the expertise to provide operational knowledge and recommendations that help covered entities increase savings and maintain compliance. Our team has experience with most split-billing vendors, wholesalers and billing systems. We understand the complexities of building and maintaining a 340B program. Clients request our help with many different aspects of their program, including—but not limited to—registration assistance, policy and procedure development, child site review and maximization, development of contract pharmacy arrangements and split-billing software implementation assistance and optimization.
- Continual Monitoring
- BKD can help provide continual monitoring, which allows 340B-covered entities to assess risk associated with compliance, test split-billing software and perform a review of 340B accumulation factors that potentially reduce savings. Continual monitoring also is needed for covered entities that have self-reported compliance issues and are required to pay back savings to a manufacturer. The process allows these entities to continue purchasing 340B drugs, repay manufacturers and get back on track for 340B compliance.
- Mega Guidance
- HRSA released the proposed guidance on August 28, 2015. The guidance includes recommended changes and clarifications to several 340B program items, such as patient definition, group purchasing organization clarification, inpatient discharge prescriptions, infusion services, independent audit expectation and Medicaid managed care organizations. HRSA sent its final 340B mega guidance to the Office of Management and Budget for review last year. The future of the proposed guidance is uncertain; HRSA withdrew the mega guidance in January, allowing current 340B guidance to continue.