Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel. - PubMed - NCBI
Appl Transl Genom. 2016 May 25;10:19-24. doi: 10.1016/j.atg.2016.05.004. eCollection 2016.
Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel.
Messner DA1,
Al Naber J1,
Koay P1,
Cook-Deegan R2,
Majumder M3,
Javitt G4,
Deverka P5,
Dvoskin R4,
Bollinger J4,
Curnutte M3,
Chandrasekharan S6,
McGuire A3.
Abstract
This research aims to inform policymakers by engaging expert stakeholders to identify, prioritize, and deliberate the most important and tractable policy barriers to the clinical adoption of next generation sequencing (NGS). A 4-round Delphi policy study was done with a multi-stakeholder panel of 48 experts. The first 2 rounds of online questionnaires (reported here) assessed the importance and tractability of 28 potential barriers to clinical adoption of NGS across 3 major policy domains: intellectual property, coverage and reimbursement, and FDA regulation. We found that: 1) proprietary variant databases are seen as a key challenge, and a potentially intractable one; 2) payer policies were seen as a frequent barrier, especially a perceived inconsistency in standards for coverage; 3) relative to other challenges considered, FDA regulation was not strongly perceived as a barrier to clinical use of NGS. Overall the results indicate a perceived need for policies to promote data-sharing, and a desire for consistent payer coverage policies that maintain reasonably high standards of evidence for clinical utility, limit testing to that needed for clinical care decisions, and yet also flexibly allow for clinician discretion to use genomic testing in uncertain circumstances of high medical need. KEYWORDS:
Clinical genomics; Coverage and reimbursement; FDA regulation; Intellectual property; Next generation sequencing; Personalized medicine
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