title: Payer decision making for next-generation sequencing-based genetic tests: insights from cell-free DNA prenatal screening.
abstract: Cell-free DNA (cfDNA) prenatal screening tests have been rapidly adopted into clinical practice, due in part to positive insurance coverage. We evaluated the framework payers used in making coverage decisions to describe a process that should be informative for other sequencing tests.
  
  
  
  We analyzed coverage policies from the 19 largest US private payers with publicly available policies through February 2016, building from the University of California San Francisco TRANSPERS Payer Coverage Policy Registry.
  
  
  
  All payers studied cover cfDNA screening for detection of trisomies 21, 18, and 13 in high-risk, singleton pregnancies, based on robust clinical validity (CV) studies and modeled evidence of clinical utility (CU). Payers typically evaluated the evidence for each chromosomal abnormality separately, although results are offered as part of a panel. Starting in August 2015, 8 of the 19 payers also began covering cfDNA screening in average-risk pregnancies, citing recent CV studies and updated professional guidelines. Most payers attempted, but were unable, to independently assess analytic validity (AV).
  
  
  
  Payers utilized the standard evidentiary framework (AV/CV/CU) when evaluating cfDNA screening but varied in their interpretation of the sufficiency of the evidence. Professional guidelines, large CV studies, and decision analytic models regarding health outcomes appeared highly influential in coverage decisions.Genet Med advance online publication 22 September 2016.
authors.affiliation: Division of Medical Genetics, Department of Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: Andrew P
authors.identifier: 0000-0002-6482-8654
authors.initials: AP
authors.lastname: Dervan
authors.affiliation: American Institutes for Health Research and Innovation, Chapel Hill, North Carolina, USA.|Eshelman School of Pharmacy, Center for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Patricia A
authors.identifier: 0000-0002-1777-4286
authors.initials: PA
authors.lastname: Deverka
authors.affiliation: Department of Clinical Pharmacy, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, California, USA.|Center for Business Models in Healthcare, Chicago, Illinois, USA.|Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Julia R
authors.initials: JR
authors.lastname: Trosman
authors.affiliation: Department of Clinical Pharmacy, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, California, USA.|Center for Business Models in Healthcare, Chicago, Illinois, USA.|Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Christine B
authors.identifier: 0000-0003-3918-0048
authors.initials: CB
authors.lastname: Weldon
authors.affiliation: Department of Clinical Pharmacy, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, California, USA.
authors.forename: Michael P
authors.identifier: 0000-0001-8517-6678
authors.initials: MP
authors.lastname: Douglas
authors.affiliation: Department of Clinical Pharmacy, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, California, USA.|Philip R. Lee Institute for Health Policy, University of California San Francisco, San Francisco, California, USA.|Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA.
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Phillips
mesh_terms: D000073888:Cell-Free Nucleic Acids / Q000235:genetics*; D000066491:Clinical Decision-Making; D003657:Decision Making; D004314:Down Syndrome / Q000175:diagnosis / Q000235:genetics; D005260:Female; D005820:Genetic Testing; D059014:High-Throughput Nucleotide Sequencing / Q000379:methods*; D006801:Humans; D019458:Insurance Coverage; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000379:methods*; D012042:Registries; D017422:Sequence Analysis, DNA / Q000379:methods*; D014314:Trisomy / Q000175:diagnosis* / Q000235:genetics; D000073839:Trisomy 13 Syndrome / Q000175:diagnosis / Q000235:genetics; D000073842:Trisomy 18 Syndrome / Q000175:diagnosis / Q000235:genetics
chemical_list: D000073888:Cell-Free Nucleic Acids