Clinical Laboratory Fee Schedule Annual Laboratory Meeting

FINAL- June 19, 2019

Clinical Laboratory Fee Schedule Annual Laboratory Meeting Agenda

Centers for Medicare & Medicaid Services Central Office Auditorium (Baltimore, Maryland)

Monday, June 24, 2019

This meeting provides a forum for the public to make presentations and submit written comments on new and reconsidered Clinical Laboratory Fee Schedule (CLFS) codes for the calendar year (CY) 2020 and provide comments on other specified CLFS issues. Please note that only codes listed in our Clinical Laboratory Fee Schedule CY 2020 Updates file, located on the web at , will be addressed.

Note: Session times are approximate and subject to change. The order of presentations is based on the date/time of receipt of the slide deck (Appendix D). Teleconference and live streaming connection details are provided using instructions described in Appendices A-C.

8:30 a.m. Arrival and Check-In

AGENDA

9:00 a.m.

Welcome and Introductions Rasheeda Arthur, PhD. Meeting Facilitator, Hospital Ambulatory Provider Group, CMS

9:10 a.m.

Carol Blackford Director, Hospital Ambulatory Provider Group, CMS

9:20 a.m.

Session I: Public Presentations on CY 2020 New and Reconsidered Codes (Appendix D) *Note: This session will contain 10 minute presentations from pre-registered presenters on specific CLFS codes with recommendations for either gap-filling or crosswalking for code payment determinations.

12:00 p.m. Lunch Break

12:45 p.m. Session I (Appendix D; Continued) 3:30 p.m. Break

3:45 p.m. 4:00 p.m. 5:00 p.m.

Session II: Discussion of Automated Chemistry Test Panels Sarah Shirey-Losso Director, Division of Ambulatory Services, CMS

Facilitated Discussion *Note: We will plan for an open dialogue about recent interest in automated chemistry test panels and implications of payment given PAMA. If interested parties would like to read a prepared statement, they may sign up during Session 1.

Meeting Adjourns

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Appendix A: Instructions to access the webinar via WebEx

To join the meeting using WebEx, connect to the conference using the link below:

Appendix B: Instructions for Teleconference access (not using WebEx) To join meeting by telephone only:

------------------------------------------------1. Dial: 1-844-396-8222

2. Your WebEx Meeting Number: 905 266 259

Having trouble dialing in? Try these backup numbers: US Toll: +1-415-527-5035 Global call-in numbers:

Access code: 905 266 259.

Appendix C. To join the meeting using YouTube:

NOTE: There is a different YouTube URL for the morning and afternoon session. YouTube Public URLs: June 24, 2019

1. MORNING SESSION June 24, 2019, Medicare CLFS Annual Laboratory Meeting

2. AFTERNOON SESSION June 24, 2019 Medicare CLFS Annual Laboratory Meeting

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FINAL- June 19, 2019

Appendix D: List of Presenters and codes to be reviewed.

Item # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Presenter

Grifols Diagnostics Solutions, Inc. Precision Diagnostics DermaTech, Inc. ? Jansen MicroGenDx Illumina, Inc. Decipher Biosciences Rady Children's Institute for Genomic Medicine Commonwealth Diagnostics International, Inc. Bio-Rad Laboratories Novartis Cernostics AutoGenomics Ethos Laboratories BioFire Mayo Clinic

16 Laboratory for Personalized Molecular Medicine 17 Eurofins NTD, LLC 18 Viracor Eurofins 19 EnteroTrack, LLC 20 MagArray, Inc. 21 Singulex 22 Kashi Clinical Laboratories 23 Ambry Genetics 24 21st Century Medicine 25 American Association for Clinical Chemistry

26 Hologic, Inc. 27 Castle Biosciences 28 Cairn Diagnostics 29 Accelerate Diagnostics, Inc. 30 American College of Medical Genetics and Genomics 31 American Clinical Laboratory Association (ACLA) 32 College of American Pathologists (CAP) 33 Qiagen 34 Association for Molecular Pathology

35 Functional Fluidics 36 Stemina Biomarker Discovery, Inc. 37 American Society for Clinical Pathology (ASCP) 38 Myriad Genetic Laboratories, Inc. 39 Lucid Diagnostics 40 MLabs

Code number

0084U 0082U 0089U 0112U 0111U 815XX 0094U 0085U 0064U-0065U 8XX01 0108U 0078U 0016U-0017U 0097U-0100U 8XX0X, 80XX0-80XX02, 802XX802X1, 0070U-0077U and 0119U-0120U 0046U, 0049U 0124U-0128U 0118U 0095U 0092U 0107U 0087U-0088U 0101U-0103U and 0129U-0138U 815X0, 0090U, 0108U, and 0111U 81163, 81165, 8XX0X-8XX01, and 813X1-813X2 8XXXX 8XX03 0106U 0086U 813X1-813X2 Multiple codes Multiple codes 0066U 81163, 81165, 813X1, 813X2, 8XX01, 8XX0X and 8XXXX 0121U-0123U 0063U Multiple codes 815X0, 0090U 0114U 0113U

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