Kathryn Phillips, PhD: Understanding how payers make coverage policies on genetic tests

Coverage and reimbursement of new technologies is essential, but often lacking particularly for personalized medicine. This presentation will describe our new UCSF Center for Translational and Policy Research (TRANSPERS) Payer Coverage Policy Registry, which systematically examines what tests are covered or not covered by payers, what factors are considered in coverage decisions, and how coverage policies vary. This is the first systematic registry of private payer coverage policies focusing on genetic tests, and includes data on multiple payers and tests across a range of testing indications.

I describe the Registry and discuss initial findings on coverage for multi-gene panels and sequencing technologies. A paradigm shift has occurred as genetic testing has shifted from single-gene tests to multi-gene panels and sequencing technologies that allow (relatively) inexpensive and rapid testing for multiple genetic variations. As of 2015, there were 55 relevant policies from the largest five private payers. Coverage varied across tests and payers, and there were no payers covering panels for drug metabolism testing or whole exome/whole genome sequencing. I will also describe an example of Registry findings provided by our study in Nature Biotechnology (Clain, 2015). We found that although payers cover single gene BRCA1/2 single-gene testing for high risk individuals, many payers consider panels investigational or experimental. Although 76% of payers have coverage policies about panels, none of these policies provides positive coverage

I conclude with a discussion of how payer coverage policies can be best understood in the context of a changing health care system. This discussion will be relevant to other emerging technologies in addition to personalized medicine.

The UCSF TRANSPERS Payer Coverage Registry was developed with a team of collaborators from multiple institutions (UCSF, Tufts Medical Center, American Institutes for Research, and Center for Business Models in Healthcare), with funding from the National Human Genome Research Institute (R01HG007063). Launched in 2008, TRANSPERS is a first-of-its-kind research center dedicated to developing evidence-based information for patients, providers, industry, researchers and policymakers to objectively assess how personalized medicine can be most beneficial and efficient in improving health outcomes. The TRANSPERS Center has been funded by grants from NIH and several foundations.