Kathryn A Phillips1, Julia R Trosman2, Michael P Douglas3, Bruce D Gelb4, Bart S Ferket5, Lucia A Hindorff6, Anne M Slavotinek7, Jonathan S Berg8, Heidi V Russell9, Beth Devine10, Veronica Greve11, Hadley Stevens Smith12. 1. UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California San Francisco, San Francisco, CA; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, CA; UCSF Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, CA. Electronic address: Kathryn.Phillips@ucsf.edu. 2. UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California San Francisco, San Francisco, CA; Center for Business Models in Healthcare, Glencoe, IL. 3. UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California San Francisco, San Francisco, CA. 4. Mindich Child Health and Development Institute and Departments of Pediatrics and Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY. 5. Institute for Healthcare Delivery Science, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY. 6. Division of Genomic Medicine, NHGRI, NIH, Bethesda, MD. 7. Institute for Human Genetics, University of California, San Francisco, CA; Division of Medical Genetics, Department of Pediatrics, University of California, San Francisco, CA. 8. The University of North Carolina at Chapel Hill, Chapel Hill, NC. 9. Department of Pediatrics, Baylor College of Medicine, Houston, TX. 10. University of Washington, Seattle, WA. 11. HudsonAlpha Institute for Biotechnology, Huntsville, AL. 12. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX.
Abstract
PURPOSE: There is limited payer coverage for genome sequencing (GS) relative to exome sequencing (ES) in the U.S. Our objective was to assess payers' considerations for coverage of GS versus coverage of ES and requirements payers have for coverage of GS. The study was conducted by the NIH-funded Clinical Sequencing Evidence-Generating Research Consortium (CSER). METHODS: We conducted semi-structured interviews with representatives of private payer organizations (payers, N = 12) on considerations and evidentiary and other needs for coverage of GS and ES. Data were analyzed using thematic analysis. RESULTS: We described four categories of findings and solutions: demonstrated merits of GS versus ES, enhanced methods for evidence generation, consistent laboratory processes/sequencing methods, and enhanced implementation/care delivery. Payers see advantages to GS vs. ES and are open to broader GS coverage but need more proof of these advantages to consider them in coverage decision-making. Next steps include establishing evidence of benefits in specific clinical scenarios, developing quality standards, ensuring transparency of laboratory methods, developing clinical centers of excellence, and incorporating the role of genetic professionals. CONCLUSION: By comparing coverage considerations for GS and ES, we identified a path forward for coverage of GS. Future research should explicitly address payers' conditions for coverage.
PURPOSE: There is limited payer coverage for genome sequencing (GS) relative to exome sequencing (ES) in the U.S. Our objective was to assess payers' considerations for coverage of GS versus coverage of ES and requirements payers have for coverage of GS. The study was conducted by the NIH-funded Clinical Sequencing Evidence-Generating Research Consortium (CSER). METHODS: We conducted semi-structured interviews with representatives of private payer organizations (payers, N = 12) on considerations and evidentiary and other needs for coverage of GS and ES. Data were analyzed using thematic analysis. RESULTS: We described four categories of findings and solutions: demonstrated merits of GS versus ES, enhanced methods for evidence generation, consistent laboratory processes/sequencing methods, and enhanced implementation/care delivery. Payers see advantages to GS vs. ES and are open to broader GS coverage but need more proof of these advantages to consider them in coverage decision-making. Next steps include establishing evidence of benefits in specific clinical scenarios, developing quality standards, ensuring transparency of laboratory methods, developing clinical centers of excellence, and incorporating the role of genetic professionals. CONCLUSION: By comparing coverage considerations for GS and ES, we identified a path forward for coverage of GS. Future research should explicitly address payers' conditions for coverage.
Authors: Julia R Trosman; Christine B Weldon; Michael P Douglas; Allison W Kurian; R Kate Kelley; Patricia A Deverka; Kathryn A Phillips Journal: J Natl Compr Canc Netw Date: 2017-02-10 Impact factor: 11.908
Authors: Stephen F Kingsmore; Julie A Cakici; Michelle M Clark; Mary Gaughran; Michele Feddock; Sergey Batalov; Matthew N Bainbridge; Jeanne Carroll; Sara A Caylor; Christina Clarke; Yan Ding; Katarzyna Ellsworth; Lauge Farnaes; Amber Hildreth; Charlotte Hobbs; Kiely James; Cyrielle I Kint; Jerica Lenberg; Shareef Nahas; Lance Prince; Iris Reyes; Lisa Salz; Erica Sanford; Peter Schols; Nathaly Sweeney; Mari Tokita; Narayanan Veeraraghavan; Kelly Watkins; Kristen Wigby; Terence Wong; Shimul Chowdhury; Meredith S Wright; David Dimmock Journal: Am J Hum Genet Date: 2019-09-26 Impact factor: 11.025
Authors: Julia R Trosman; Christine B Weldon; Michael P Douglas; Patricia A Deverka; John B Watkins; Kathryn A Phillips Journal: Value Health Date: 2017-01 Impact factor: 5.725
Authors: Kathryn A Phillips; Patricia A Deverka; Julia R Trosman; Michael P Douglas; James D Chambers; Christine B Weldon; Andrew P Dervan Journal: Nat Biotechnol Date: 2017-07-12 Impact factor: 54.908
Authors: Julia R Trosman; Michael P Douglas; Su-Ying Liang; Christine B Weldon; Allison W Kurian; Robin K Kelley; Kathryn A Phillips Journal: Value Health Date: 2020-03-19 Impact factor: 5.725
Authors: Julia R Trosman; Christine B Weldon; Anne Slavotinek; Mary E Norton; Michael P Douglas; Kathryn A Phillips Journal: Genet Med Date: 2019-09-10 Impact factor: 8.822
Authors: Michelle M Clark; Zornitza Stark; Lauge Farnaes; Tiong Y Tan; Susan M White; David Dimmock; Stephen F Kingsmore Journal: NPJ Genom Med Date: 2018-07-09 Impact factor: 8.617