title: Payer Coverage for Hereditary Cancer Panels: Barriers, Opportunities, and Implications for the Precision Medicine Initiative.
abstract: Background:Hereditary cancer panels (HCPs), testing for multiple genes and syndromes, are rapidly transforming cancer risk assessment but are controversial and lack formal insurance coverage. We aimed to identify payers' perspectives on barriers to HCP coverage and opportunities to address them. Comprehensive cancer risk assessment is highly relevant to the Precision Medicine Initiative (PMI), and payers' considerations could inform PMI's efforts. We describe our findings and discuss them in the context of PMI priorities.Methods:We conducted semi-structured interviews with 11 major US payers, covering >160 million lives. We used the framework approach of qualitative research to design, conduct, and analyze interviews, and used simple frequencies to further describe findings.Results:Barriers to HCP coverage included poor fit with coverage frameworks (100%); insufficient evidence (100%); departure from pedigree/family history-based testing toward genetic screening (91%); lacking rigor in the HCP hybrid research/clinical setting (82%); and patient transparency and involvement concerns (82%). Addressing barriers requires refining HCP-indicated populations (82%); developing evidence of actionability (82%) and pathogenicity/penetrance (64%); creating infrastructure and standards for informing and recontacting patients (45%); separating research from clinical use in the hybrid clinical-research setting (44%); and adjusting coverage frameworks (18%).Conclusions:Leveraging opportunities suggested by payers to address HCP coverage barriers is essential to ensure patients' access to evolving HCPs. Our findings inform 3 areas of the PMI: addressing insurance coverage to secure access to future PMI discoveries; incorporating payers' evidentiary requirements into PMI's research agenda; and leveraging payers' recommendations and experience to keep patients informed and involved.
authors.affiliation: UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco, San Franscisco, California|Center for Business Models in Healthcare, Chicago, Illinois|Feinberg School of Medicine, Northwestern University, Chicago, Illinois
authors.forename: Julia R
authors.initials: JR
authors.lastname: Trosman
authors.affiliation: UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco, San Franscisco, California|Center for Business Models in Healthcare, Chicago, Illinois|Feinberg School of Medicine, Northwestern University, Chicago, Illinois
authors.forename: Christine B
authors.initials: CB
authors.lastname: Weldon
authors.affiliation: UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco, San Franscisco, California
authors.forename: Michael P
authors.initials: MP
authors.lastname: Douglas
authors.affiliation: Departments of Medicine and of Health Research and Policy, Stanford University School of Medicine, Stanford, California
authors.forename: Allison W
authors.initials: AW
authors.lastname: Kurian
authors.affiliation: UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco, San Franscisco, California|Department of Medicine, Division of Hematology/Oncology, University of California, San Francisco, San Francisco, Califorina|Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California
authors.forename: R Kate
authors.initials: RK
authors.lastname: Kelley
authors.affiliation: American Institutes for Research, Chapel Hill, North Carolina
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Deverka
authors.affiliation: UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco, San Franscisco, California|Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California|Philip R. Lee Institute for Health Policy, University of California, San Francisco, San Francisco, California
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Phillips
mesh_terms: D005820:Genetic Testing / Q000191:economics*; D006297:Health Services Accessibility / Q000191:economics; D006801:Humans; D019458:Insurance Coverage; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D009369:Neoplasms / Q000175:diagnosis* / Q000235:genetics; D057285:Precision Medicine / Q000191:economics* / Q000379:methods; D036301:Qualitative Research; D018570:Risk Assessment / Q000379:methods; D014481:United States