Insurance Coverage Policies for Pharmacogenomic and Multi-Gene Testing for Cancer

Abstract

Insurance coverage policies are a major determinant of patient access to genomic tests. The objective of this study was to examine differences in coverage policies for guideline-recommended pharmacogenomic tests that inform cancer treatment. We analyzed coverage policies from eight Medicare contractors and 10 private payers for 23 biomarkers (e.g., HER2 and EGFR) and multi-gene tests. We extracted policy coverage and criteria, prior authorization requirements, and an evidence basis for coverage. We reviewed professional society guidelines and their recommendations for use of pharmacogenomic tests. Coverage for KRAS, EGFR, and BRAF tests were common across Medicare contractors and private payers, but few policies covered PML/RARA, CD25, or G6PD. Twelve payers cover at least one multi-gene test for nonsmall cell lung cancer, citing emerging clinical recommendations. Coverage policies for single and multi-gene tests for cancer treatments are relatively consistent among Medicare contractors despite the lack of national coverage determinations. In contrast, coverage for these tests varied across private payers. Patient access to tests is governed by prior authorization among eight private payers. Substantial variations in how payers address guideline-recommended pharmacogenomic tests and the common use of prior authorization underscore the need for additional studies of the effects of coverage variation on cancer care and patient outcomes.

The landscape of pharmacogenetic testing in a US managed care population

“…Lu and colleagues reported variability in insurance coverage policies and prior authorization requirements for single-and multiplegene pharmacogenetic tests for somatic variants influencing cancer treatment. 19 However, insurance coverage of precision medicine-related tests in oncology is gaining traction. For example, in 2018 the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination for next-generation sequencing tests that detect genetic variants in solid tumors of patients with advanced cancer, thus providing information for cancer diagnosis and treatment.…”

“…17 The most commonly covered pharmacogenetic tests among commercial insurers and Medicare at that time included CYP2C19 for clopidogrel, CYP2D6 for tetrabenazine, HLA-B*15:02 for carbamazepine (only for persons of Asian ancestry), and HLA-B*57:01 for abacavir. 17,19 Another factor complicating the insurance coverage landscape is that documentation of pharmacogenetic testing in claims and medical records has been inconsistent and has changed over time. The Current Procedural Terminology (CPT) coding system is used to code medical services and procedures, including pathology and laboratory tests that encompass pharmacogenetic testing.…”

Clinical Molecular Marker Testing Data Capture to Promote Precision Medicine Research Within the Cancer Research Network

“…To reduce inappropriate use of targeted therapies, preauthorization and provider attestation to the presence of the molecular target are often required by insurers, particularly those that operate outside of the integrated systems described in our article. 52 Molecular Marker Data Capture in the Cancer Research Network and the inability to conduct research across multiple health systems. This is important because any one system may not have sufficient power to examine the outcomes of precision medicine approaches.…”

Understanding Implementation Challenges to Genetic Testing for Familial Hypercholesterolemia in the United States

“…Health care policies and insurance coverages for genetic testing vary considerably within the US and internationally [17]. Moreover, countries with limited access to or less broadly available financial coverage of genetic testing may question the costs and benefits of FH genetic testing, especially since insurance payers deny reimbursement for genetic testing when testing is deemed investigational versus medically necessary [18,19,20,21,22].…”

“…Outside the research settings, free genetic testing is unlikely or uncommon in non-socialized health care systems like that of the US [19]. Insurance coverage denial or minimal insurance coverage of genetic testing would potentially burden patients with large out-of-pocket costs or surprise bills [17,20,25,26].…”