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Payer Perspectives of Genomic Testing: Results from a Systematic Literature Review

Ethical Legal Social Issues (ELSI) Public Health and Policy
  • Primary Categories:
    • Health services and Implementation
  • Secondary Categories:
    • Health services and Implementation
Introduction:
As utilization has increased, the costs and complexities of genomic testing have made this area a priority for US health care payers, though the approaches to coverage and reimbursement decisions have been inconsistent among plans and in comparison to guidelines.  The coverage of genomic tests and services has been a key facilitator to or barrier to patient access and provider utilization, making this an impactful area of study.  A review of United States health care payers’ perspectives on genomic testing has not been performed, despite much of the testing economy relying on this stakeholder group.  

Methods:
We conducted a systematic review of the peer-reviewed academic literature using PRISMA guidelines for publications reporting US payer perspectives between 1/1/2000 and 6/30/2024 (Figure 1).   Data collected included title, authors, year, objectives, study design, population studied, instrumentation used, type of genomic testing. A framework analysis approach was used to thematically categorize and organize data across 20 studies undergoing full review, inclusion, and data abstraction. Major domains from were identified and data iteratively analyzed and integrated into the framework for all included records by multiple reviewers. 

 

Results:
Publication dates ranged from 2009 to 2022.  Interview, survey and discussions account for most studies reflecting payer perspectives. Our analysis framework identified seven major domains relating to payer perspectives of genomic testing. Domains included clinical utility, coverage decision frameworks, potential harms, costs, “paying for research”, demand/pressure, flexibility of outcomes considered, and personal utility (Table 1). Clinical utility was the most referenced domain across studies, and described as having evidence that a test result was used to guide care resulting in improved health outcomes in a real-world setting.  Cost of the test itself, the cost of the test compared to alternatives or interventions were reported as influential in coverage assessments, yet some payers reported not considering costs at all. Many studies report that existing coverage decision frameworks are not easily applied to genomic tests compared to other services, particularly when evaluating panel tests.  Potential harms or risks of genomic testing gave payers pause in consideration of coverage, such as incidental findings, VUS, and off-label/inappropriate treatment. “Paying for research” was a specific concern, and payers felt that many genomic tests evaluated have some research application rather than being entirely for clinical application. Demand or pressure was reported to impact prioritization of policies or reviews based on increased costs, political or press attention, utilization, guideline adoption as standard of care, and provider and patient demand. Personal utility is a well-studied set of outcomes from genomic testing, yet payers are challenged to value these outcomes in traditional decision frameworks or definitions of clinical utility.   Study methodologies were heterogeneous and addressed different areas of genomic testing. 

Conclusion:
Payers are among the most influential stakeholders in US healthcare and yet, there has been little research to understand how they make decisions surrounding genomic testing.  From available literature there are insights into key domains such as a common definition of clinical utility, the willingness of some payers to expand beyond that definition, the importance but challenge of cost consideration, and variability among perspectives and approaches.  These insights may serve as a base to inform practices which enhance payer coverage and to develop more research and expand upon or discover new areas of influence within payer decision-making.

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