Genetic Testing Insurance Coverage Trends: A Review of Publicly Available Policies from the Largest us Payers

Graf, Michael D.; Needham, Denise F; Teed, Nicole; Brown, Trisha

doi:10.2217/pme.13.9

Cited by 44 publications

(44 citation statements)

References 14 publications

(3 reference statements)

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“…To date, coverage of genetic tests has been inconsistent, with some payers covering a particular test but other payers not (10;11). This inconsistency creates confusion for patients and clinicians as to who has access to these tests and how they are used in clinical practice.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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show abstract

“…Generally, coverage decisions are influenced by whether the test is diagnostic, preventive, or informational and whether the test has both clinically validity and utility. 13 …”

Section: The State Of Insurance Coverage Pre-acamentioning

confidence: 99%

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Prince

2015

J Law and the BioSci

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Clinical use of genetic testing to predict adult onset conditions allows individuals to minimize or circumvent disease when preventive medical interventions are available. Recent policy recommendations and changes expand patient access to information about asymptomatic genetic conditions and create mechanisms for expanded insurance coverage for genetic tests. The American College of Medical Genetics and Genomics (ACMG) recommends that laboratories provide incidental findings of medically actionable genetic variants after whole genome sequencing. The Patient Protection and Affordable Care Act (ACA) established mechanisms to mandate coverage for genetic tests, such as BRCA. The ACA and ACMG, however, do not address insurance coverage for preventive interventions. These policies equate access to testing as access to prevention, without exploring the accessibility and affordability of interventions. In reality, insurance coverage for preventive interventions in asymptomatic adults is variable given the US health insurance system’s focus on treatment. Health disparities will be exacerbated if only privileged segments of society can access preventive interventions, such as prophylactic surgeries, screenings, or medication. To ensure equitable access to interventions, federal or state legislatures should mandate insurance coverage for both predictive genetic testing and recommended follow-up interventions included in a list established by an expert panel or regulatory body.

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“…In a recent study of the publicly available genetic testing coverage policies of private payers, 50% of respondents specifically referenced the need for evidence of clinical utility; tests that were uniformly covered tended to be those supported by clear evidence and recommended by professional and governmental guidelines. 32 …”

Section: Background Common To Public and Private Payersmentioning

confidence: 99%

Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges

Deverka¹,

Dreyfus

2014

J. Law. Med. Ethics

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Public and private payers face complex decisions regarding whether, when, and how to cover and reimburse for next generation sequencing (NGS)‐based tests. Yet a predictable reimbursement pathway is critical both for patient access and incentives to provide the market with better clinical evidence. While preliminary data suggests that payers will use similar evidentiary standards as those used to evaluate established molecular diagnostic tests, the volume and complexity of information generated by NGS raises a host of additional considerations for payers that are specific to this technology.

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Genetic Testing Insurance Coverage Trends: A Review of Publicly Available Policies from the Largest us Payers

Abstract: Genetic services are addressed by many large health plans. Challenges remain in ensuring consistency and currency of payer policy for genetic tests.

Cited by 44 publications

References 14 publications

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

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

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges

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