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. 2014 Fall;42 Suppl 1(Suppl 1):22-41.
doi: 10.1111/jlme.12160.

Clinical integration of next generation sequencing: coverage and reimbursement challenges

Affiliations

Clinical integration of next generation sequencing: coverage and reimbursement challenges

Patricia A Deverka et al. J Law Med Ethics. 2014 Fall.

Abstract

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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Figures

Figure 1
Figure 1
Next Generation Sequencing Process

References

    1. See Mauer CB, Pirzadeh-Miller SM, Robinson LS, et al. The Integration of Next-Generation Sequencing Panels in the Clinical Cancer Genetics Practice: An Institutional Experience. Genetics in Medicine. 2013;16(5):407–412.Dewey FE, Grove ME, Pan C, et al. Clinical Interpretation and Implications of Whole-Genome Sequencing. JAMA. 2014;311(10):1035–1044.

    1. Secretary's Advisory Committee on Genetics Health, and Society, Coverage and Reimbursement of Genetic Tests and Services. 2006
    1. Deverka P, Doksum T, Carlson R. Integrating Molecular Medicine into the US Health-Care System: Opportunities, Barriers, and Policy Challenges. Clinical Pharmacology and. Therapeutics. 2007;82(4):427–434. - PubMed
    1. Wilson C, Schulz S, Waldman S. Biomarker Development, Commercialization, and Regulation: Individualization of Medicine Lost in Translation. Clinical Pharmacology and Therapeutics. 2007;81(2):153–155. - PubMed
    2. Rogowski WH, Grosse SD, Khoury MJ. Challenges of Translating Genetic Tests into Clinical and Public Health Practice. Nature Reviews Genetics. 2009;10(7):489–495. - PubMed
    1. UnitedHealth Center for Health Reform & Modernization . Personalized Medicine: Trends and Prospects for the New Science of Genetic Testing and Molecular Diagnostics. Blue Cross Blue Shield Association, Technology Evaluation Center Criteria; Minnetonka, Minnesota: 2012. [June 18, 2014]. Working Paper 7, available at < http://bcbs.com/blueresources/tec/>.