According to results of 340B Health’s 2018 annual survey, “82% of hospitals reported that it would hurt their ability to provide more patient care services” if their hospital lost or had their 340B savings limited.1 This and many other similar statistics support why every 340B program should involve executive stakeholders. In fact, executives should actively participate in a covered entity’s 340B oversight committee.2 At minimum, they should engage in the overall value of the 340B program, including its compliance risks, financial opportunities, key advocacy efforts, and program resources and structure.

Program Value
One of the most important ways to get and keep executives engaged in a 340B program is to routinely report on its value.3 Importantly, entities should continually explain why the savings exist and what changes are occurring. By consistently communicating the program’s value, covered entities can then advocate for ways to increase that value or put into place the mechanisms to maintain the program. Advocacy Executives should engage in all major advocacy efforts. They can accomplish this through routine updates on legislative and regulatory concerns at the 340B oversight committee meeting. In certain instances, issues may be too timely to wait for the routine committee meeting, so having a venue to communicate with executives in real time is also important. These conversations could include executives with responsibility for compliance, finance, operations, and regulatory affairs.

Compliance Risks
A covered entity may need to follow new processes to maintain compliance to its 340B program.

For example, if a covered entity is converting from a “charge on dispense” to a “charge on administration” billing model for its mixed-use inventory, it may need resources dedicated to this conversion and oversight after implementation. If no resources are in place, the facility could lose out on appropriate medication waste charges and thus 340B accumulations. By communicating the potential financial impact on the 340B program, covered entities could put themselves in a better position to get new resources.

Financial Opportunities
A covered entity may want to take on a project to build the 340B program’s value. For example, expanding contract pharmacy capture rates can increase both program value and compliance. When presenting the potential project to the 340B oversight committee and any other executive stakeholders, 340B program leaders must include the cost of new needs and resources to accomplish this project.

Resources and Structure
Another important aspect of partnering with 340B executive stakeholders is ensuring that the right 340B resources and team structure are in place. This can be complicated for large and small covered entities alike. Smaller covered entities often require that associates take on multiple roles. Larger covered entities may operate as part of a larger system that can contain multiple 340B covered entities. Leaders of 340B programs should consistently assess their team’s resources, structure, and work compared with other 340B programs. Many avenues exist to help leaders complete this assessment. Apexus4 and 340B Health5 have published resources that leaders can use. Additionally, some 340B consulting firms can help assess an organization’s structure compared with best practices.6

Conclusions
Executive stakeholders are important members of the 340B team. Although an executive must formally be the covered entity’s authorizing official, executives should serve more as champions for 340B programs. By engaging in compliance risks, financial opportunities, program resources and structure, and 340B advocacy and value, executives can bring important insight and help ensure that each 340B program fits into the larger picture of health care in the community being served.
 
Jacob Thompson, PharmD, MS, 340B ACE, is CEO of Elevate340B in Draper, Utah, and a pharmacist auditor for Turnkey Pharmacy Solutions in Salt Lake City, Utah.

Ashley Mains Espinosa, PharmD, MS, CPHIMS, FASHP, is director of system pharmacy business services at SCL Health in Denver, Colorado.



REFERENCES
  1. Evaluating 340B hospital savings and their use in supporting care for rural and low-income patients. 340B Health website. 340bhealth.org/files/2018_Annual_ Survey_Report_FINAL.pdf. Published June 2019. Accessed April 1, 2020.
  2. Peek GK, Williams AM. 340B oversight: interdisciplinary approach ensures continuous compliance. Pharmacy Times®. November 30, 2017. pharmacytimes. com/publications/health-system-edition/2017/november2017/340b-oversight-interdisciplinary-approach-ensures-continuous-compliance. Accessed April 1, 2020.
  3. Williams AM, Marcelin HL. Documenting 340B value is key to success. Pharmacy Times®. March 31, 2019. pharmacytimes.com/publications/ health-system-edition/2019/march2019/documenting-340b-value-is-key-to-success. Accessed April 1, 2020.
  4. 340B FTE request. Apexus. docs.340bpvp.com/documents/public/resourcecenter/ 340B-FTE-Request-Template.pptx. Published 2019. Accessed April 1, 2020.
  5. Membership survey analysis: 340B staffing resources. 340B Health. 340bhealth.org/files/340B_StaffingResources.pdf. Accessed April 1, 2020.
  6. Espinosa AM, Starling M. 340B focus: working with consultants. Pharmacy Times®. September 11, 2018. pharmacytimes.com/publications/health-system-edition/ 2018/september2018/340b-focus-working-with-consultants. Accessed April 6, 2020.