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Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges

Published online by Cambridge University Press:  01 January 2021

Patricia A. Deverka  and
Jennifer C. Dreyfus
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Extract

Clinical next generation sequencing (NGS) is a term that refers to a variety of technologies that permit rapid sequencing of large numbers of DNA segments, up to and including entire genomes. As an approach that is playing an increasingly important role in obtaining genetic information from patients, it may be viewed by public and private payers either positively, as an enabler of the promised benefits of personalized medicine, or as “the perfect storm” resulting from the confluence of high market demand, an uproven technology, and an unprepared delivery system. A number of recent studies have noted that coverage and reimbursement will be critical for clinical integration of NGS, yet the evidentiary pathway for payer decision-making is unclear. Although there are multiple reasons for this uncertain reimbursement environment, the situation stems in large part from a long-standing lack of alignment between the information needs of regulators and post-regulatory decision-makers such as payers.

Type
JLME Supplement
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue S1 , Fall 2014 , pp. 22 - 41
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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References

See Mauer, C. B., Pirzadeh-Miller, S. M., Robinson, L. S. et al., “The Integration of Next-Generation Sequencing Panels in the Clinical Cancer Genetics Practice: An Institutional Experience,” Genetics in Medicine 16, no. 5 (2013): 407–412; Dewey, F. E., Grove, M. E., and Pan, C. et al., “Clinical Interpretation and Implications of Whole-Genome Sequencing,” JAMA 311, no. 10 (2014): 1035–1044.CrossRefGoogle Scholar
Secretary's Advisory Committee on Genetics, Health, and Society, Coverage and Reimbursement of Genetic Tests and Services (2006).Google Scholar
Deverka, P., Doksum, T., and Carlson, R., “Integrating Molecular Medicine into the US Health-Care System: Opportunities,” Barriers, and Policy Challenges, Clinical Pharmacology and. Therapeutics 82, no. 4 (2007): 427–434.CrossRefGoogle Scholar
Wilson, C., Schulz, S., and Waldman, S., “Biomarker Development, Commercialization, and Regulation: Individualization of Medicine Lost in Translation,” Clinical Pharmacology and Therapeutics 81, no. 2 (2007): 153–155; Rogowski, W. H., Grosse, S. D., and Khoury, M. J., “Challenges of Translating Genetic Tests into Clinical and Public Health Practice,” Nature Reviews Genetics 10, no 7 (2009): 489–495.CrossRefGoogle Scholar
UnitedHealth Center for Health Reform & Modernization, Personalized Medicine: Trends and Prospects for the New Science of Genetic Testing and Molecular Diagnostics, Working Paper 7 (Minnetonka, Minnesota, 2012); Blue Cross Blue Shield Association, Technology Evaluation Center Criteria, available at <http://bcbs.com/blueresources/tec> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
Trosman, J., van Bebber, S., and Phillips, K., “Coverage Policy Development for Personalized Medicine: Private Payer Perspectives on Developing Policy for the 21-Gene Assay,” Journal of Oncology Practice 6, no. 5 (2010): 238–242; Palmetto, MolDx Technical Assessment Process, available at <http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Frequently%20Asked%20Questions~8N3ELL4072?opennavmenu=BrowseByTopic||||> (last visited June 18, 2014).CrossRefGoogle Scholar
See UnitedHealth Center for Health Reform & Modernization, supra note 5.Google Scholar
Raskin, A. and Casdin, E., The Dawn of Molecular Medicine: The Transformation of Medicine and Its Consequences for Investors: Executive Summary (New York: AllianceBernstein, 2011)Google Scholar
Tuckson, R., Newcomer, L., and De Sa, J., “Accessing Genomic Medicine: Affordability, Diffusion, and Disparities,” JAMA 309, no 14(2013): 1469–1470.CrossRefGoogle Scholar
See UnitedHealth Center for Health Reform & Modernization, supra note 5.Google Scholar
Deverka, P., “Pharmacogenomics, Evidence, and the Role of Payers,” Public Health Genomics 12, no. 3 (2009): 149–157.CrossRefGoogle Scholar
Garber, A. M., “Evidence-Based Coverage Policy,” Health Affairs 20, no. 5 (2001): 62–82; Aetna, “Utilization Management: Guidelines for Determining Coverage,” available at <http://www.aetna.com/healthcare-professionals/policies-guidelines/determining_coverage.html> (last visited June 18, 2014); See UnitedHealth Center for Health Reform & Modernization, supra note 5.CrossRefGoogle Scholar
Williams, M., “Insurance Coverage for Pharmacogenomics Testing in the USA,” Personalized Medicine 4, no. 4 (2007): 479–487.CrossRefGoogle Scholar
AMCP Format for Formulary Submissions Version 3.1 AMCP Format Addendum: Companion Diagnostic Tests (CDTs) December 2012, available at <http://amcp.org/Tertiary.aspx?id=8435terms=formulary%20submissions> (last visited August 7, 2014).+(last+visited+August+7,+2014).>Google Scholar
Schrijver, I., Aziz, N., and Farkas, D. H. et al., “Opportunities and Challenges Associated with Clinical Diagnostic Genome Sequencing: A Report of the Association for Molecular Pathology,” Journal of Molecular Diagnostics 14, no. 6 (2012): 525–540; see Blue Cross Blue Shield Association, supra note 5.CrossRefGoogle Scholar
Id.Google Scholar
See UnitedHealth Center for Health Reform & Modernization, supra note 5.Google Scholar
Sun, F., Bruening, W., and Uhl, S., et al., Technology Assessment: Quality, Regulation and Clinical Utility of Laboratory-Developed Molecular Tests, Corrected Version (Agency for Healthcare Research and Quality Technology Assessment Program, 2010).Google Scholar
Id.Google Scholar
Id.Google Scholar
Collins, F. S. and Hamburg, M. A., “First FDA Authorization for Next-Generation Sequencer,” New England Journal of Medicine 369, no. 25 (2013): 2369–2371.CrossRefGoogle Scholar
Paxton, A., CAP Today, “CAP Leads Way with Next-Gen Checklist,” August 2012, available at <http://www.cap.org/apps/cap.portal?_nfpb=truecntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow_windowLabel=cntvwrPtltcntvwrPtlt%7BactionForm.contentReference%7D=cap_today%2F0812%2F0812b_cap_leads_way.html_state=maximized_pageLabel=cntvwr> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
Rehm, H. L., Bale, S. J., and Bayrak-Toydemir, P. et al., “ACMG Clinical Laboratory Standards for Next-generation Sequencing,” Genetics in Medicine 15, no. 9 (2013): 733–747.CrossRefGoogle Scholar
Gargis, A. S., Kalman, L., and Berry, M. W. et al., “Assuring the Quality of Next-Generation Sequencing in Clinical Laboratory Practice,” Nature Biotechnology 30, no. 11 (2012): 1033–1036.CrossRefGoogle Scholar
Id.Google Scholar
Kamalakaran, S., Varadan, V., and Janevski, A. et al., “Translating Next Generation Sequencing to Practice: Opportunities and Necessary Steps,” Molecular Oncology 7, no. 4 (2013): 743–755.CrossRefGoogle Scholar
Ong, F. S., Lin, J. C., and Das, K. et al., “Translational Utility of Next-Generation Sequencing,” Genomics 102, no. 3 (2013): 137–139.CrossRefGoogle Scholar
Katsanis, S. H. and Katsanis, N., “Molecular Genetic Testing and the Future of Clinical Genomics,” Nature Reviews Genetics 14, no. 6 (2013): 415–426.CrossRefGoogle Scholar
See Rehm, et al., supra note 23.Google Scholar
Teutsch, S., Bradley, L., and Palomaki, G. et al., “The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Initiative: Methods of the EGAPP Working Group,” Genetics in Medicine 11, no. 1 (2009): 3–14.CrossRefGoogle Scholar
Meckley, L. M. and Neumann, P. J., “Personalized Medicine: Factors Influencing Reimbursement,” Health Policy 94, no. 2 (2010): 91–100.CrossRefGoogle Scholar
Graf, M., Needham, D., and Teed, N. et al., “Genetic Testing Insurance Coverage Trends: A Review of Publicly Available Policies from the Largest US Payers,” Future Medicine 10, no. 3 (2013): 235–243.Google Scholar
Veenstra, D., Piper, M., and Haddow, J. et al., “Improving the Efficiency and Relevance of Evidence-Based Recommendations in the Era of Whole-Genome Sequencing: An EGAPP Methods Update,” Genetics in Medicine 15, no. 1 (2013): 14–24.CrossRefGoogle Scholar
Centers for Disease Control and Prevention, “Genomic Tests and Family History by Levels of Evidence,” available at <http://www.cdc.gov/genomics/gtesting/tier.htm> (last visited May 9, 2013).+(last+visited+May+9,+2013).>Google Scholar
GAPPFinder, available at <http://www.hugenavigator.net/GAPPKB> (last visited August 2, 2013).+(last+visited+August+2,+2013).>Google Scholar
Hayes Inc., “Genetic Test Evaluation,” available at <http://www.hayesinc.com/hayes/health-plans/genetic-test-evaluation/> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
ECRI Institute, “Health Technology Assessment Information Service: Patient-Centered Outcomes Research and Evidence-based Reports for Better Health Technology Decisions,” available at <https://www.ecri.org/Products/Pages/htais.aspx> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
Wolf, R., “A CEO's Guide to Molecular Diagnostic Reimbursement: Navigating the Many Challenges of Reimbursement and Commercialization,” DARK Daily Laboratory and Pathology News, available at <http://www.darkdaily.com/white-papers/a-ceos-guide-to-molecular-diagnostic-reimbursement-0416#form> (last visited June 18, 2014). (last visited June 18, 2014).' href=https://scholar.google.com/scholar?q=Wolf,+R.,+“A+CEO's+Guide+to+Molecular+Diagnostic+Reimbursement:+Navigating+the+Many+Challenges+of+Reimbursement+and+Commercialization,”+DARK+Daily+Laboratory+and+Pathology+News,+available+at++(last+visited+June+18,+2014).>Google Scholar
See Blue Cross Blue Shield Association, supra note 5.Google Scholar
See Palmetto, , supra note 6.Google Scholar
Palmetto, GBA, “Molecular Diagnostic Program (MolDXSM) Coverage, Coding, and Pricing Standards and Requirements,” available at <http://www.palmettogba.com/palmetto/moldx.nsf/MolDX_Manual.pdf> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
Id.Google Scholar
Personal communication from Jeter, E. to author, February 25, 2013.Google Scholar
Lyon, E. and Weiss, R., “The Shifting Regulatory Sands for Clinical Laboratories: The FDA and Other Things,” December 15, 2011, available at <http://www.arup.utah.edu/media/shifting/The%20Shifting%20Regulatory%20Sands%20for%20Clinical%20Laboratories-BRANDED%20v2.pdf> (last visited June 18, 2014); Wintering, C., “The Evolving MolDX Program in Quadax,” 2012, available at <http://www.quadax.com/newsletter/2012feb/MolDX.htm> (last visited June 18, 2014); Letter from American Clinical Laboratory Association to Elaine Jeter, December 2, 2011, available at <http://www.acla.com/comment-letter-on-palmetto-lcd-for-molecular-diagnostic-tests/> (last visited June 18, 2014).+(last+visited+June+18,+2014);+Wintering,+C.,+“The+Evolving+MolDX+Program+in+Quadax,”+2012,+available+at++(last+visited+June+18,+2014);+Letter+from+American+Clinical+Laboratory+Association+to+Elaine+Jeter,+December+2,+2011,+available+at++(last+visited+June+18,+2014).>Google Scholar
Letter from Association for Molecular Pathology to Becke Turner, August 29, 2013 available at <http://www.amp.org/publications_resources/position_statements_letters/documents/2013/Palmetto%20DLCD%20MDT%20DL33599.pdf> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
Abraham, M., Ahlman, J. T., and Boudreau, A. J., Current Procedural Terminology (CPT): Professional Education (American Medical Association, 2013).Google Scholar
Proposal to Address CPT Coding for Genomic Sequencing Procedures (Association for Molecular Pathology, 2013).Google Scholar
Id.Google Scholar
“McKesson, AMA Developing Reference Product for MDx,” GenomeWeb Daily News, February 26, 2013, available at <http://www.genomeweb.com/clinical-genomics/mckessonama-developing-reference-product-mdx> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
42 C.F.R. § 414.508 (2014).Google Scholar
Quorum Consulting, Diagnostics Reimbursement Quarterly 1, no. 1 (August 2012), available at <http://quorumconsulting.com/docs/Quorum_Diagnostics_Reimbursement_Quarterly_Vol_1,_Issue_1_Aug_2012.pdf> (last visited June 18, 2014); Xifin, “Mopath Code Fees by Payor,” available at <http://www.xifin.com/resources/forms-tools/mopath-code-fees-by-payor?mkt_tok=3RkMMJWWfF9wsRolu6TPZKXonjHpfsX56e0qXa%2BwlMI%2F0ER3fOvrPUfGjI4DSMFqI%2FqLAzICFpZo2FFAE%2Baccg%3D%3D> (last visited June 18, 2014).+(last+visited+June+18,+2014);+Xifin,+“Mopath+Code+Fees+by+Payor,”+available+at++(last+visited+June+18,+2014).>Google Scholar
Consensus statement from American Association for Clinical Chemistry, American Clinical Laboratory Association, American College of Medical Genetics and Genomics, American Society for Clinical Pathology, American Society for Histocompatibility and Immunogenetics, Association for Molecular Pathology, California Clinical Laboratory Association, College of American Pathologists, Society for Inherited Metabolic Disorders, available at <http://www.amp.org/about/Press_Releases/ConsensusStatement_ProfSoc(5102013).pdf> (last visited June 18, 2014).+(last+visited+June+18,+2014).>Google Scholar
Ray, T., “CMS Issues Pricing for MDx Codes; Labs, Test Developers Still Critical of Rates and Methodology,” GenomeWeb, May 22, 2013, available at <http://www.genomeweb.com/clinical-genomics/cms-issues-pricing-mdx-codes-labs-test-developers-still-critical-rates-and-metho> (login required; last visited May 5, 2014).+(login+required;+last+visited+May+5,+2014).>Google Scholar
See Wolf, , supra note 38; Carlson, B., “Seeking a Coding Solution for Molecular Tests: Managing the Estimated 1,700 Molecular Tests Now on the Market Is Impossible without a Unique CPT Code for Each Test. What's at Stake? The Future of Personalized Medicine,” Biotechnology Healthcare 7, no. 3 (2010): 16–20.Google Scholar
See UnitedHealth Center for Health Reform & Modernization, supra note 5.Google Scholar
See Meckley, and Neumann, , supra note 31.Google Scholar
See UnitedHealth Center for Health Reform & Modernization, supra note 5.Google Scholar
Walcoff, S. D. and Pfeifer, J. D., “Modernizing US Regulatory and Reimbursement Policy to Support Continued Innovation in Genomic Pathology,” Personalized Medicine 9, no. 3 (2012): 295–308.CrossRefGoogle Scholar
Centers for Medicare and Medicaid Services, National Coverage Determination (NCD) for Cyotgenetic Studies, available at <http://cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=198ncdver=1bc=AgAAgAAAAAAAAA%3d%3d> (last visited June 23, 2014).+(last+visited+June+23,+2014).>Google Scholar
Centers for Medicare and Medicaid Services, National Coverage Determination (NCD) for Pharmacogenomic Testing for Warfarin Response (90.1), available at <http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=333ncdver=1IsPopup=yNCAId=224NcaName=Pharmacogenomic+Testing+for+Warfarin+Responsebc=AAAAAAAACAAAAA%3D%3D> (last visited June 23, 2014).+(last+visited+June+23,+2014).>Google Scholar
Blue Cross Blue Shield, Special Report: Exome Sequencing for Clinical Diagnosis of Patients with Suspected Genetic Disorders, August 2013, available at <http://www.bcbs.com/blueresources/tec/vols/28/28_03.pdf> (last visited June 23, 2014).+(last+visited+June+23,+2014).>Google Scholar
Genome Web, “William Blair Downgrades Sequenom, Citing Coding Issues and Increased Competition; Shares Down Sharply,” July 25, 2013, available at <http://www.genomeweb.com/sequencing/william-blair-downgrades-sequenom-citing-coding-issues-and-increased-competition> (last visited June 23, 2014).+(last+visited+June+23,+2014).>Google Scholar
Id.Google Scholar
FoundationOne, Billing and Reimbursement: Answers for Patients and Caregivers,” available at <http://www.foundationone.com/learn.php#5> (last visited May 12, 2013).+(last+visited+May+12,+2013).>Google Scholar
Aetna Clinical Policy Bulletin: Tumor Markers, Number 0352, available at <http://www.aetna.com/cpb/medical/data/300_399/0352.html> (last visited March 31, 2014).+(last+visited+March+31,+2014).>Google Scholar
Blue Cross Blue Shield Association, “Sequencing-Based Tests to Determine Fetal Down Syndrome (Trisomy 21) from Maternal Plasma DNA,” Technology Evaluation Center Assessment Program Executive Summary No. 10 (2013).Google Scholar
Id.Google Scholar
See Schrijver, et al., supra note 15.Google Scholar
Ormond, K. E., Wheeler, M. T., and Hudgins, L. et al., “Challenges in the Clinical Application of Whole-Genome Sequencing,” The Lancet 375, no. 9727 (2010): 1749–1751.CrossRefGoogle Scholar
Biesecker, L., Burke, W., and Kohane, I. et al., “Next-Generation Sequencing in the Clinic: Are We Ready?” Nature Reviews Genetics 13, no. 11 (2012): 818–824.CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
ACMG, American College of Medical Genetics Policy Statement: Points to Consider in the Clinical Application of Genomic Sequencing, May 15, 2012, available at <http://www.acmg.net/StaticContent/PPG/Clinical_Application_of_Genomic_Sequencing.pdf> (last visited June 23, 2014); ACMG, ACMG Updates Recommendation on “Opt Out” for Genome Sequencing Return of Results, Press Release, available at <https://www.acmg.net/docs/Release_ACMGUpdatesRecommendations_final.pdf> (last visited June 23, 2014).+(last+visited+June+23,+2014);+ACMG,+ACMG+Updates+Recommendation+on+“Opt+Out”+for+Genome+Sequencing+Return+of+Results,+Press+Release,+available+at++(last+visited+June+23,+2014).>Google Scholar
Ross, L. F., Rothstein, M. A., and Clayton, E. W., “Mandatory Extended Searches in All Genome Sequencing: ‘Incidental Findings,’ Patient Autonomy, and Shared Decision Making,” JAMA 310, no. 4 (2013): 367–368; Green, R. C., Lupski, J. R., and Biesecker, L. G., “Reporting Genomic Sequencing Results to Ordering Clinicians: Incidental, But Not Exceptional,” JAMA 310, no. 4 (2013): 365–366.CrossRefGoogle Scholar
See Rehm, et al., supra note 23.Google Scholar
See Schrijver, et al., supra note 15; Meric-Bernstam, F., Farhangfar, C., and Mendelsohn, J. et al., “Building a Personalized Medicine Infrastructure at a Major Cancer Center,” Journal of Clinical Oncology 31, no. 15 (2013): 1849–1857; Moorthie, S., Hall, A., and Wright, C. F., “Informatics and Clinical Genome Sequencing: Opening the Black Box,” Genetics in Medicine 15, no. 3 (2013): 165–171.Google Scholar
See Biesecker, et al., supra note 70.Google Scholar
See Schrijver, et al., supra note 15.Google Scholar
Saffitz, J. E., “Genomic Pathology: A Disruptive Innovation,” Personalized Medicine 9, no. 3 (2012): 237–239.CrossRefGoogle Scholar
See Moorthie, et al., supra note 76.Google Scholar
Id.Google Scholar
Berger, A. and Olson, S., The Economics of Genomic Medicine: Workshop Summary (Institute of Medicine, Washington, D.C., 2013).Google Scholar
Olson, S., Beachy, S., Giammaria, C., and Berger, A., Integrating Large-Scale Genomic Information into Clinical Practice: Roundtable on Translating Genomic-Based Research for Health: Workshop Summary (Institute of Medicine, Washington, D.C., 2012); see Ormond, et al., supra note 69.Google Scholar
See Ormond, et al., supra note 69.Google Scholar
Crawford, J. M. and Aspinall, M. G., “The Business Value and Cost–Effectiveness of Genomic Medicine,” Personalized Medicine 9, no. 3 (2012): 265–286.CrossRefGoogle Scholar
See Moorthie, et al., supra note 76.Google Scholar
See Biesecker, et al., supra note 70.Google Scholar
See UnitedHealth Center for Health Reform & Modernization, supra note 5.Google Scholar
Id.Google Scholar
Engstrom, P. F., Bloom, M. G., and Demetri, G. D. et al., “NCCN Molecular Testing Paper: Effectiveness, Efficiency, and Reimbursement,” Journal of the National Comprehensive Cancer Network 9, no. S6 (2011): S-1–S-16.CrossRefGoogle Scholar
Id.Google Scholar
See Katsanis, and Katsanis, , supra note 28; see Ormond, et al., supra note 69.Google Scholar
Green, R. C., Berg, J. S., and Grody, W. W. et al., “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574.CrossRefGoogle Scholar
Burke, W., Antommaria, A. H. M., and Bennett, R. et al., “Recommendations for Returning Genomic Incidental Findings? We Need to Talk!” Genetics in Medicine 15, no. 11 (2013): 854–859.CrossRefGoogle Scholar
Id.Google Scholar
See Saffitz, , supra note 79.Google Scholar
See Schrijver, et al., supra note 15.Google Scholar
Id.Google Scholar
See Rehm, et al., supra note 23; see ACMG (American College of Medical Genetics Policy Statement), supra note 73Google Scholar
See Schrijver, et al., supra note 15.Google Scholar
Id.Google Scholar
Gottesman, O., Kuivaniemi, H., and Tromp, G. et al., “The Electronic Medical Records and Genomics (Emerge) Network: Past, Present, Future,” Genetics in Medicine 15, no. 10 (2013) 761–771.CrossRefGoogle Scholar
Goldenberg, A. J. and Sharp, R. R., “The Ethical Hazards and Programmatic Challenges of Genomic Newborn Screening,” JAMA 307, no. 5 (2012): 461–462.CrossRefGoogle Scholar
U.S. Department of Health and Human Services, Discretionary Advisory Committee on Heritable Disorders in Newborns and Children,” available at <http://www.hrsa.gov/advisory-committees/mchbadvisory/heritabledisorders/about/index.html> (last visited March 21, 2014).+(last+visited+March+21,+2014).>Google Scholar
Karow, J., “With Up to $25M in NIH Funding, Four Pilot Projects Will Test Genome Sequencing in Newborn Screening,” Genome Web, September 4, 2013, available at <http://www.genomeweb.com/sequencing/25m-nih-funding-four-pilot-projects-will-test-genome-sequencing-newborn-screenin> (login required; last visited May 4, 2014).+(login+required;+last+visited+May+4,+2014).>Google Scholar
Bell, C., Dinwiddie, D., and Miller, N. et al., “Carrier Testing for Severe Childhood Recessive Diseases by Next-Generation Sequencing,” Science Translational Medicine 3, no. 65 (2011): 65ra4.CrossRefGoogle Scholar
Id.Google Scholar
Jackson, L. and Pyeritz, R. E., “Molecular Technologies Open New Clinical Genetic Vistas,” Science Translational Medicine 3, no. 65 (2011): 65ps2.CrossRefGoogle Scholar
See ACMG (American College of Medical Genetics Policy Statement), supra note 73.Google Scholar
Id.Google Scholar
King, J. S., “Genetic Tests: Politics and Fetal Diagnostics Collide,” Nature 491, no. 7422 (2012): 33–34.CrossRefGoogle Scholar
Rebouche, R. and Rothenberg, K., “Mixed Messages: The Intersection of Prenatal Genetic Testing and Abortion,” Howard Law Journal 55, no. 3 (2012): 983–1023.Google Scholar
Heger, M., “Using NGS as CDx Will Require Paradigm Shift, Regulatory Changes, According to Experts at AACR,” Genome Web, April 16, 2014, available at <http://www.genomeweb.com/sequencing/using-ngs-cdx-will-require-paradigm-shift-regulatory-changes-according-experts-a> (login required; last visited May 4, 2014).+(login+required;+last+visited+May+4,+2014).>Google Scholar
See Blue Cross Blue Shield Association, supra note 66.Google Scholar
Deverka, P., Messner, D., and Dutta, T., Effectiveness Guidance Document: Evaluation of Clinical Validity and Clinical Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (Center for Medical Technology Policy, Baltimore, MD, 2013); Simonds, N. I., Khoury, M. J., and Schully, S. D. et al., “Comparative Effectiveness Research in Cancer Genomics and Precision Medicine: Current Landscape and Future Prospects,” Journal of the National Cancer Institute 105, no. 13 (2013): 929–936.Google Scholar
Blue Cross Blue Shield Association, “Special Report: Multiple Molecular Testing of Cancers to Identify Targeted Therapies,” Technology Evaluation Center Assessment Program Exeutive. Summary 28, no. 1 (2013).Google Scholar
Frampton, G., “Validation of a Comprehensive NGS-Based Cancer Genomic Assay for Clinical Use,” Presented at the American Association for Clinical Chemistry Annual Meeting, July 17, 2012; see Veenstra, et al., supra note 33.Google Scholar
See Deverka, et al., supra note 115.Google Scholar
Duan, N., Kravitz, R. L., and Schmid, C. H., “Single-Patient (N-of-1) Trials: A Pragmatic Clinical Decision Methodology for Patient-Centered Comparative Effectiveness Research,” Journal of Clinical Epidemiology 66, no. S8 (2013): S21–S28; Gabler, N. B., Duan, N., and Vohra, S. et al., “N-of-1 Trials in the Medical Literature: A Systematic Review,” Medical Care 49, no. 8 (2011): 761–768.CrossRefGoogle Scholar
Lillie, E. O., Patay, B., and Diamant, J. et al., “The N-of-1 Clinical Trial: The Ultimate Strategy for Individualizing Medicine?” Personalized Medicine 8, no. 2 (2011): 161–173.CrossRefGoogle Scholar
National Institutes of Health, “NIH Program Explores the Use of Genomic Sequencing in Newborn Healthcare,” available at <http://www.nih.gov/news/health/sep2013/nhgri-04.htm> (last visited June 24, 2014).+(last+visited+June+24,+2014).>Google Scholar
Armstrong, J., “Implementing Genomic Medicine Programs: Financial Impact,” (PowerPoint presentation), May 3–4, 2012, available at <http://www.genome.gov/Multimedia/Slides/GenomicMedicineIII/GM3_Armstrong.pdf> (last visited March 20, 2013).+(last+visited+March+20,+2013).>Google Scholar
Carlson, B., “Payers Try New Approaches to Manage Molecular Diagnostics: Some Payers Require Prior Authorization for Molecular Diagnostic Testing and Some Don't. And Some Payers Are Looking at Other Options,” Biotechnology and Healthcare 7, no. 3 (2010): 26–30.Google Scholar
GenomeWeb, “Health Reform Covers Breast Cancer Test,” March 2013, available at <http://www.genomeweb.com/print/1201536?hq_e=elhq_m=1522655hq_l=1hq_v=e46e070ad2> (login required; last visited March 20, 2013).+(login+required;+last+visited+March+20,+2013).>Google Scholar
Center for Medical Technology Policy, “Green Park Collaborative,” available at <http://www.cmtpnet.org/featured-proj-ects/green-park-collaborative/> (last visited June 24, 2014).+(last+visited+June+24,+2014).>Google Scholar
Medical Device Innovation Consortium homepage, available at <http://mdic.org/> (last visited June 24, 2014).+(last+visited+June+24,+2014).>Google Scholar
National Biomarker Development Alliance homepage, available at <http://www.nbdabiomarkers.org/> (last visited May 4, 2014).+(last+visited+May+4,+2014).>Google Scholar
See Berger, and Olson, , supra note 82; Simonds, et al., supra note 115.Google Scholar