State legislative trends related to biomarker testing

Abstract

Comprehensive biomarker testing has become the standard of care for informing the choice of the most appropriate targeted therapy for many patients with advanced cancer. Despite evidence demonstrating the need for comprehensive biomarker testing to enable the selection of appropriate targeted therapies and immunotherapy, the incorporation of biomarker testing into clinical practice lags behind recommendations in National Comprehensive Cancer Network guidelines. Coverage policy differences across insurance health plans have limited the accessibility of comprehensive biomarker testing largely to patients whose insurance covers the recommended testing or those who can pay for the testing, and this has contributed to health disparities. Furthermore, even when insurance coverage exists for recommended biomarker testing, patients may incur burdensome out-of-pocket costs depending on their insurance plan benefits, which may also create barriers to testing. Prior authorization for biomarker testing for some patients can add an administrative burden and may delay testing and thus treatment if it is not done in a timely manner. Recently, three states (Illinois, Louisiana, and California) passed laws designed to improve access to biomarker testing at the state level. However, there is variability among these laws in terms of the population affected, the stage of cancer, and whether the coverage of testing is mandated, or the legislation addresses only prior authorization. Advocacy efforts by patient advocates, health care professionals, and professional societies are imperative at the state level to further improve coverage for and access to appropriate biomarker testing.

A local perspective on internal, external, and reflexive biomarker testing processes for lung cancer in an academic medical center

“…However, the policies have limitations. 21 Ongoing advocacy for increasing reimbursement, especially to allow flexibility for ordering testing in uncertain circumstances, was among the most urgent recommendations by a Delphi panel convened on cost issues related to biomarker testing in NSCLC. 20 Clinicians in our sample described 1-2 weeks as a typical turnaround time, which may faster than other institutions' turnaround times.…”

“…Barriers to biomarker testing related to external, internal, and reflex tests that were endorsed by clinicians are listed in Table -4. 9,10,[16][17][18][19][20][21][22] Potential solutions suggested by clinicians or proposed in the literature are listed alongside identified barriers.…”

“…Advocate for insurers and policy makers to appropriately reimburse for biomarker testing (Messner 2016, 20 Sadigh 2022 21 ).…”

Overcoming Barriers to Discovery and Implementation of Equitable Pharmacogenomic Testing in Oncology

“…94 In recent years, a number of states have enacted requirements for state-regulated private insurers, and state Medicaid plans cover evidence-based biomarker testing, including PGx testing. 95…”

“…"54 No PGx tests are considered to be a companion diagnostic; however, for a couple of gene/drug pairs, such as HLA-B*15:02-carbamazepine, FDA makes an explicit requirement for genotype testing before prescribing within the label. In cases when testing is required, coverage is more favorable compared with coverage for when labeling only mentions genotype testing or dose reductions on the basis of genotype testing as a consideration for prescribers,93 and FDA's lack of explicit testing requirements have been cited by payors in decisions not to cover PGx testing.94 In recent years, a number of states have enacted requirements for state-regulated private insurers, and state Medicaid plans cover evidence-based biomarker testing, including PGx testing 95.…”