Coverage, Price, and Reimbursement for Multigene Tests for Cancer and Related Conditions
Location(s): United States
New technologies are enabling the use of genetic tests that measure multiple rather than single genes. However, these tests raise questions such as: Will multigene tests be covered by insurers when appropriate so that there is neither overuse nor underuse because of cost? How will coverage, price, and reimbursement for multigene tests influence testing practices in clinical settings, particularly in safety net settings? Our findings will benefit public health by improving our understanding of coverage policies and the role of test cost in decisionmaking - decisions that ultimately impact patient, provider, and societal health and economic outcomes.New technologies are enabling the use of genetic tests that measure multiple rather than single genes (gene panels and whole exome/genome sequencing tests). However, these tests raise questions such as: Will multigene tests be covered by insurers when appropriate so that there is neither overuse nor underuse because of cost? How will coverage, price, and reimbursement for multigene tests influence testing practices across diverse providers and clinical sites, particularly in safety net settings? Our objective is to examine “coverage, price, and reimbursement” (“CPR”) for multigene tests broadly and for cancer- related indications specifically: why tests are covered/not covered by payers, how this is changing over time, and how CPR influences testing decisions and practices in clinic settings. Specific aims are:
1) Examine publicly available payer coverage policies a) Analyze factors associated with coverage/non-coverage and how these are evolving (2015-2019), building from pilot data from our unique, systematic Payer Coverage Policy Registry b) Conduct in-depth analyses exploring why tests are covered/not covered, using data from payer interviews and a Symposium that engages payers, clinicians, and researchers
2) Examine influence of CPR on testing decisions and practices in clinic settings for cancer testing (germline and tumor)
a) Conduct semi-structured interviews with genetic counselors, physicians, and clinic administrators in seven sites, including safety net and community clinics, to examine how CPR influences testing in actual practice across diverse providers and sites
b) Conduct a national, quantitative survey of genetic counselors to obtain data on how CPR influences testing decisions and practices at the point of care. These synergistic Aims examine an important topic using an innovative, mixed-methods approach. We address why tests are covered/not covered, how this is changing over time, and how CPR influences testing practices by
(1) analyzing systematic data on actual coverage policies
(2) assessing the role of payers and providers – not only physicians but also genetic counselors and clinic administrators
(3) examining seven diverse clinic sites – not only academic medical centers but also community and safety net clinics, and
(4) analyzing data from a national survey of genetic counselors.
Study outcomes will provide information on what issues need to be addressed and possible solutions, and contribute to the overarching objectives of developing policies and practices that are transparent, consistent, and equitable (regardless of whether tests are covered or not) and that will help patients have access to testing when clinically appropriate.