340B Compliance: Tips to Maintaining a Successful Program
Since its induction in 1992, the 340B Drug Pricing Program has been responsible for helping eligible covered entities stretch scarce federal resources and increase services to patients of the covered entity.
Since its induction in 1992, the 340B Drug Pricing Program, managed by the Health Resources and Services Administration (HRSA), has been responsible for helping eligible covered entities stretch scarce federal resources and increase services to patients of the covered entity.1 Participation in this program allows a significant discount on qualifying outpatient medication purchases. These savings come with the responsibility to adhere to program requirements designated by HRSA2,3:
- Maintenance of accurate 340B database information
- Eligibility recertification
- Prevention of duplicate discounts
- Prevention of diversion to ineligible patients
- Preparation for program audits
Attention on the 340B program by government officials, government agencies (eg, the Government Accountability Office), and organizations (eg, AIR340B), coupled with the initiation of HRSA audits, has caused many covered entities to become more aware and focused on the management of the 340B program. As a result, many covered entities have taken steps to hire an employee(s) for the sole purpose of maintaining 340B program integrity. These emerging 340B-focused consultants and 340B-program managers (or similar roles) help covered entities obviate instances of noncompliance, such as duplicate discounts, diversion, and inaccurate 340B database information, by completing a multitude of functions, including:
- Reviewing and updating information on the HRSA database;
- Validating accuracy of provider files, location maps, National Drug Code mapping/crosswalks, etc
- Performing day-to-day functions for maintaining 340B software (including updates to billing units and other mapping functions)
- Educating staff on 340B program regulations and ensuring appropriate staff knowledge of 340B-related policies and procedures
- Reviewing HRSA updates for the drug pricing program
- Documenting 340B program value to the covered entity and the community it serves
- Organizing 340B governance committees
- Conducting internal audits
A vital piece to maintaining a compliant program is the integration of self-audits by the covered entity. Initiating routine audits, such as monthly audits of mixed-use and contract pharmacy(ies), quarterly reviews of the 340B database, and annual mock HRSA audits (internal and/or external), helps to ensure program compliance and allows the covered entity to be well prepared for an HRSA or a manufacturer audit.
Program integrity is a fundamental priority for the HRSA and should be considered as such by participating covered entities. Through guidance and educational opportunities provided by the HRSA, Apexus, and other 340B organizations, stakeholders are learning more about how to successfully run complaint programs.
Halena Leah Marcelin is a 340B program manager for Memorial Healthcare System in South Florida. She completed the 2-year Health-System Pharmacy Administration residency with the University of North Carolina Hospitals and Clinics and received her master of science in Pharmaceutical Sciences from the University of North Carolina in 2015. David Dakwa is a fourth-year PharmD/MBA candidate at Palm Beach Atlantic University in West Palm Beach, Florida. He completed his bachelor of arts in Integrative Biology from the University of California, Berkeley, in 2011.
- HR Rep No 102-384(II), at 12 (1992).
- Program requirements. Health Resources and Services Administration website. hrsa.gov/opa/programrequirements/index.html. Accessed June 2, 2016.
- Program integrity. Health Resources and Services Administration website. hrsa.gov/opa/programintegrity/index.html. Accessed June 2, 2016.