Existing AMA policy acknowledges the increasingly important role of genomic-based precision medicine applications. It also calls for the development of educational resources and tools to assist in the implementation of genomic-based medicine, and supports appropriate use of genetic testing, pre- and post-test counseling and the development of best-practice standards for such counseling.
The timeliness of the report was considered significant because of the passage of the 21st Century Cures Act and continued funding of the National Institutes of Health’s All of Us Research Program and the National Cancer Institute’s Cancer Moonshot. The report also mentions the speed and volume of advances in precision medicine, its complex and costly implementation, and the rapid generation of evidence supporting its use.
The report highlights the AMA’s general concerns about prior authorization and other utilization-management programs. The AMA worked with several state and national medical societies and patient organizations to develop 21 reform principles for these programs and more than 100 stakeholder organizations have signed on in support.
“Several large private insurers have established national prior-authorization programs for genetic/genomic testing and will deny payment for services that have not been properly authorized or, in some cases, ordered by a geneticist or genetic counselor or carried out by insurer-approved laboratories,” the report states.
Delegates agreed with the report’s recommendation to reaffirm AMA policy that utilization-management programs should permit variation to account for patient differences and allow physicians to appeal decisions.
The report highlights how considerable variability exists among private and public payers regarding the evidence they require before providing coverage of genetic tests and services. It notes that evaluation criteria generally include traditional measures such as analytical validity, clinical validity and “clinical utility,” but added that clinical utility “is a highly subjective term that does not have a universally accepted definition.”
“The councils are concerned by the lack of transparency and standardization across payer coverage determination processes, which may hinder access to valid and meaningful tests and therapeutics as well as future innovations,” the report states.