Payer coverage policies for multigene tests

Phillips, Kathryn A.; Deverka, Patricia A.; Trosman, Julia Rachel; Douglas, Michael P.; Chambers, James D.; Weldon, Christine B.; Dervan, Andrew

doi:10.1038/nbt.3912

Cited by 45 publications

(54 citation statements)

References 10 publications

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“…15 Some payers are providing coverage and reimbursement for multigene tests, but it remains variable and limited, particularly for large panels that are not targeted to specific conditions (such as whole genome sequencing). 17 There are also concerns that patients may face high out-of-pocket spending for many genetic tests. 18 …”

Section: Policy Implicationsmentioning

confidence: 99%

Genetic Test Availability And Spending: Where Are We Now? Where Are We Going?

et al. 2018

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Genetic testing and spending on that testing have grown rapidly since the mapping of the human genome in 2003. However, it is not widely known how many tests there are, how they are used, and how they are paid for. Little evidence from large data sets about their use has emerged. We shed light on the issue of genetic testing by providing an overview of the testing landscape. We examined test availability and spending for the full spectrum of genetic tests, using unique data sources on test availability and commercial payer spending for privately insured populations, focusing particularly on tests measuring multiple genes in the period 2014–17. We found that there were approximately 75,000 genetic tests on the market, with about ten new tests entering the market daily. Prenatal tests accounted for the highest percentage of spending on genetic tests, and spending on hereditary cancer tests accounted for the second-highest. Our results provide insights for those interested in assessing genetic testing markets, test usage, and health policy implications, including current debates over the most appropriate regulatory and payer coverage mechanisms.

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Section: Policy Implicationsmentioning

confidence: 99%

Genetic Test Availability And Spending: Where Are We Now? Where Are We Going?

et al. 2018

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“…3 Many individuals who are eligible for Medicare are still employed and have private insurance. Private payers do not necessarily follow Medicare’s lead for their commercial policies and may not change their policies to correspond with the CMS policy because many aspects of the policy are inconsistent with their current policies and their approaches to coverage.…”

Section: Will the New Policy Provide Appropriate And Equitable Accessmentioning

confidence: 99%

Evolving Payer Coverage Policies on Genomic Sequencing Tests

Phillips

2018

JAMA

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Reimbursement has been cited as a key barrier to the adoption of precision medicine into clinical care. 1 This issue has recently attracted attention with the March 2018 Centers for Medicare & Medicaid Services (CMS) national coverage determination on next-generation sequencing tests for patients with advanced cancer. 2This policy represents a step forward by addressing the vexing issue of coverage for these complex tests. Private and public coverage for next-generation sequencing tests for patients with cancer and those with other conditions is currently limited and variable 3 and the new policy offers a roadmap for coverage. The policy provides coverage for companion diagnostics that have approved indications by the US Food and Drug Administration for patients with advanced cancer. The final policy was significantly different from the draft issuance, which generated controversy as evidenced by 315 comments submitted to the CMS, publication of several opinion articles and editorials, and intense industry lobbying.

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“…Gene panels in this context are defined as tests that analyze multiple genes by next generation sequencing or chromosomal microarray analysis, with the resulting test report providing multiple results, not an algorithmic score. The Registry includes data on what panels and testing indications are reviewed, whether panels are covered or not covered, and the evidence and rationale for coverage decisions cited in the policy (20). …”

Section: Methodsmentioning

confidence: 99%

Examining Evidence in U.S. Payer Coverage Policies for Multi-Gene Panels and Sequencing Tests

Chambers¹,

Saret

Anderson

et al. 2017

Int J Technol Assess Health Care

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Objectives The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. Methods We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Results Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73–100 percent), clinical studies in 69 percent (50–87 percent), technology assessments 47 percent (33–86 percent), systematic reviews or meta-analyses 31 percent (7–71 percent), and CEAs 5 percent (0–7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Conclusions Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

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Payer coverage policies for multigene tests

Cited by 45 publications

References 10 publications

Genetic Test Availability And Spending: Where Are We Now? Where Are We Going?

Genetic Test Availability And Spending: Where Are We Now? Where Are We Going?

Evolving Payer Coverage Policies on Genomic Sequencing Tests

Examining Evidence in U.S. Payer Coverage Policies for Multi-Gene Panels and Sequencing Tests

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