Grayson K. Peek, PharmD, MS, BCPS, and Alexandra M. Williams, BA, CPHT
The 340b drug pricing program was enacted in 1992 with the goal of allowing eligible participants, or covered entities, “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” Through this program, covered entities are able to purchase certain manufacturers’ covered outpatient drugs at discounted prices, no greater than the 340B ceiling price.1
Each year, covered entities must recertify while attesting to their ability to remain compliant with 340B Program requirements.2
Due to this, program compliance should be at the forefront of all 340B activities for the covered entity. Organizations have begun to invest valuable resources to ensure continued program compliance through 340B focused consultants and 340B program managers (or similar roles). In order to promote compliance, these roles often focus on the provision of education to covered entity stakeholders.
The government agency charged with managing the 340B Drug Pricing Program is the Health Resources and Services Administration (HRSA). HRSA’s Office of Pharmacy Affairs (OPA) offers various educational resources to covered entities in their efforts to ensure program compliance.3
Covered entities are able to find information about Federal Register notices, policy releases, guidance, and program updates through the OPA’s online resources. The website contains information about registration, program requirements, and updates for complex issues such as contract pharmacy and the group purchasing organization (GPO) prohibition.4,5
Another source for 340B Program education is Apexus, the HRSA prime vendor for the 340B Drug Pricing Program. In addition to negotiating significant discounts for certain drugs for Prime Vendor Program participants, Apexus provides a myriad of resources and educational opportunities to covered entities, offering practical and operational information about policy application. Resources include frequently asked questions (FAQs), tools that can act as templates for compliance cornerstones (e.g., auditing practices and policies/procedures), and contact information for the national 340B Apexus Answers call center.6-8
Apexus’ 340B UniversityTM provides on-site training sessions for program participants, typically in conjunction with other industry conferences. An online version of this training, known as 340B University OnDemandTM, is available to covered entity stakeholders who may be unable to attend in person. This online option offers the flexibility of completing modules focused on specific aspects of the 340B Program, while doing so at the stakeholder’s own pace.9
Additionally, for those individuals directly involved with 340B Program operations, Apexus offers the “Advanced 340B Operations Certificate Program.” The certificate program provides specialized training to understand and overcome challenges in managing a compliant 340B Program.10
The aforementioned resources are important for those in roles related to 340B and are trusted resources to help those individuals to create entity specific training and education. This could include development of learning modules and live educational sessions supplemented by an assessment to ensure competency.11
As a best practice, the covered entity’s education plan is typically documented within the appropriate policies and procedures, and records are maintained to ensure that all stakeholders have received sufficient training.11,12
Additionally, some entities extend this training to their contract pharmacy partners to ensure that all of the staff involved in the program are receiving the same quality of training as their own covered entity staff. In addition to receiving general education and training, further education may be tailored to meet the needs of the specific stakeholder’s work setting.12
The online table is a practical example of an education and training program tailored by work setting.
Ensuring that all stakeholders have received sufficient education and training will enhance your covered entity’s ability to remain compliant with 340B Program requirements and allow for more support for program related initiatives.
Grayson K. Peek is the Coordinator of 340B Administration and Revenue Management at Duke University Hospital in Durham, North Carolina. He completed the 2-year Health-System Pharmacy Administration Residency at Duke University Hospital in conjunction with a Master of Science in Health-System Pharmacy Administration at the University of North Carolina at Chapel Hill. Dr. Peek is a PharmD graduate of the University of Tennessee Health Science Center.
Alexandra M. Williams is the 340B Program Coordinator at University of North Carolina Hospitals in Chapel Hill, North Carolina. She completed her undergraduate degree in Biology & Health Sciences at Guilford College. She is a certified pharmacy technician and has been involved in a 340B related role for over 4 years. She currently serves as a member of the Apexus Education Advisory Council.
- Health Resources and Services Administration. 340B drug pricing program omnibus guidance. Fed Regist. 2015;80:52300-52324.
- Annual recertification. Health Resources and Services Administration website. hrsa.gov/opa/recertification/recertification.html. Accessed September 28, 2016.
- 340B Drug Pricing Program. Health Resources and Services Administration website. hrsa.gov/opa/index.html. Accessed September 28, 2016.
- Office of Pharmacy Affairs update: August 2015. Health Resources and Services Administration website. hrsa.gov/opa/updates/2015/august.html. Accessed September 28, 2016.
- FAQs. Health Resources and Services Administration website. hrsa.gov/opa/faqs/. Accessed September 28, 2016.
- Education. Apexus website. apexus.com/solutions/education. Accessed September 28, 2016.
- Apexus Advanced 340B Operations Certificate Program. Apexus website. apexus.com/solutions/education/apexus-advanced-340b-certificate-program. Accessed September 28, 2016.
- Health Resources and Services Administration. 340B Peer-To-Peer Program: 340B Compliance Improvement Guide. 2015:14-17.
- Apexus. Sample 340B Program Policy & Procedures Manual: Disproportionate Share Hospital (DSH). 2016:21-22. Download: https://docs.340bpvp.com/documents/public/resourcecenter/DSH_PolicyManual.docx. Accessed September 28, 2016.