Box 1.

Lessons Learned for Implementation of Pharmacogenomics and Genomic Medicine

In the planning stages of an implementation, it is valuable to seek information and guidance from a variety of sources, including: Existing literature on established implementation frameworks that have been tested in diverse clinical and non-clinical environments; Published descriptions of pilot programs and established clinical implementations; One-on-one discussions regarding clinical challenges and solutions from early adopters for point-of-care implementation guidance and to identify resources that have been used successfully in a real-world setting; Discussions with internal stakeholders to identify patient population characteristics, institutional priorities, provider preferences, or other factors to focus on implementation efforts.

Consider resources that can be used to engage and garner support from a range of stakeholders early in the implementation process, such as formal presentation and/or handout materials defining scientific, clinical, administrative, logistical, and reimbursement challenges and opportunities within your organization.

Brief summaries of published literature demonstrating benefits and limitations of a new clinical implementation in the context of existing standards of care and/or practice guidelines can help to demonstrate the use of an evidence-based, clinically relevant approach to non-genomics providers.

Objective data and guidance on reimbursement procedures and anticipated out-of-pocket patient costs for pharmacogenetic and/or genetic testing is critical to stakeholder engagement and sustainability of a clinical implementation. In our experience, users valued resources such as regional Medicare Administrative Contractor (MAC) reimbursement rates for testing and guidance on documenting tests using current procedure terminology (CPT) codes for billing, reimbursement, and patient care records.

Although provider and patient education are consistently identified as key implementation barriers, resources such as patient and provider brochures and patient education handouts were among the least-accessed resources by users. This finding suggests lower-than-anticipated need for externally developed educational materials, possibly due to availability from laboratories or other commercial databases or potentially a preference for internally-developed educational materials that can be customized with an institutional logo, standardized formatting, or boilerplate language.

Although many early clinical pharmacogenetic and/or genomic implementations have occurred in large, academic medical centers, there is a critical need for implementation experiences and resources to support diverse practice settings, such as in rural or underserved populations, community-based hospitals, private physician practices, managed care organizations, and community pharmacies.