Jochen K. Lennerz, M.D., Ph.D.

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1 Becker s 3 rd Annual Health IT + Revenue Cycle 2017 Healthcare Infrastructure for Financially Sustainable Clinical Genomics Friday 22 nd 2017 Jochen K. Lennerz, M.D., Ph.D. Massachusetts General Hospital Department of Pathology Center for Integrated Diagnostics

2 I have no conflicts of interest

3

4 Next-generation sequencing

5 Reid Robison, Medical Director at Center for Change, University Utah

6 Why is genomics not part of clinical practice?

7 Starting point NGS + CPT = Reimbursement ( challenging )

8 technology procedure Starting point NGS + CPT = Reimbursement ( challenging ) Emerging evidence Perceived value Scientific community

9 technology procedure Starting point NGS + CPT Reimbursement ( challenging ) Emerging evidence necessary but not sufficient Perceived value Scientific community

10 technology procedure Starting point NGS + CPT = Reimbursement ( challenging ) Emerging evidence Payors Perceived value Scientific community Public

11 technology procedure Starting point NGS + CPT Reimbursement ( challenging ) Emerging evidence Perceived value Scientific community

12 technology procedure Starting point 1 NGS + CPT = Reimbursement ( challenging ) Medical Policy Coverage determination (input) Emerging evidence Payors adoption Perceived value Scientific community Public

13 Payor Rules by CPT-codes of Selected Molecular-Genetic Tests Policy-tailored claim evidence reasoning Lennerz et al., J Mol Diagnostics, 2017

14 Starting point 2 Comparison between Clinical and Research Genomics

15 The Human Pipeline of Clinical Exome and Genome Sequencing Lennerz et al., J Mol Diagnostics, 2017

16 The Human Pipeline of Clinical Exome and Genome Sequencing

17 The Human Pipeline of Clinical Exome and Genome Sequencing

18 The Human Pipeline of Clinical Exome and Genome Sequencing

19 The Human Pipeline of Clinical Exome and Genome Sequencing

20 Revenue Cycle Management

21 The Human Pipeline of Clinical Exome and Genome Sequencing Lennerz et al., J Mol Diagnostics, 2017

22 Deconstructing the Human Pipeline into Modules 8 modules 34 stories 129 tasks Pilot: 50 cases

23

24 The Human Pipeline of Clinical Exome and Genome Sequencing 1. Personnel, their interactions (and professional qualifications) 2. Acknowledge the people and their interactions as a central role in the clinical environment 3. Modular approach

25 Out of Pocket Estimates

26 Workflow

27 Letter of Medical Necessity

28 The Pilot Phase

29

30 Payor Rules by CPT-codes of Selected Molecular-Genetic Tests Policy-tailored claim evidence reasoning

31 The Human Pipeline of Clinical Exome and Genome Sequencing Test as a module

32 Summary NGS = method of choice for clinical genomics CPT = milestone towards financially sustainable clinical implementation; Achieving reimbursement is a major challenge. At least 8 functionally distinct modules (request review, costestimation, preauthorization, accessioning, pre-billing, testing, reporting, and reimbursement-consultation) Non-technical barriers are currently limiting the scope and availability of clinical genomic sequencing. The presented human pipeline is one approach towards longterm financial sustainability of clinical genomics.

33 The team (thank you) 1 Jochen K. Lennerz, M.D., Ph.D.; 2 Heather M. McLaughlin, Ph.D.; 1 Jason M. Baron, M.D.; 1 David Rasmussen; 2 Meini Sumbada Shin; 3 Nancy Berners-Lee; 1 Julie Miller Batten; 4 Kathryn J. Swoboda M.D.; 5 Manish K. Gala M.D.; 6 Harland S. Winter M.D.; 7 Jeremy D. Schmahmann M.D.; 8 David A. Sweetser M.D., Ph.D.; 1 Marianne Boswell; 1 Maciej Pacula; 9 Albrecht Stenzinger M.D.; 1 Long P. Le, M.D., Ph.D.; 1 William Hynes MHSA; 2 Heidi Rehm, Ph.D.; 10 Anne Klibanski, M.D.; 1 Stephen W. Black-Schaffer, M.D.; 11 Jeffrey A. Golden, M.D.; 1 David N. Louis, M.D.; 2 Scott T. Weiss, M.D. M.S.; and 1 A. John Iafrate, M.D., Ph.D. 1 Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; 2 Partners Healthcare Personalized Medicine, Laboratory for Molecular Medicine, Cambridge, MA, USA; 3 International Coach Federation, Lexington, MA, USA; 4 Department of Neurology, Massachusetts General Hospital/Harvard Medical School, Boston MA; 5 Clinical and Translational Epidemiology Unit & Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School; Boston, MA, USA; 6 Pediatric Gastroenterology and Nutrition, MassGeneral Hospital for Children and Harvard Medical School, Boston, MA, USA; 7 Ataxia Unit, Cognitive Behavioural Neurology Unit, Laboratory for Neuroanatomy and Cerebellar Neurobiology, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; 8 Division of Medical Genetics, Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA; 9 Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany; 10 Department of Medicine, Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; 11 The Brigham and Women s Hospital, Department of Pathology, Boston, MA, USA.

34 Healthcare Infrastructure for Financially Sustainable Clinical Genomics Friday 22 nd 2017 Joe: Massachusetts General Hospital Department of Pathology Center for Integrated Diagnostics

35 Deconstructing the Human Pipeline into Modules

36

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