American Society of Hematology American Society of Clinical Oncology www.hematology.org www.asco.org 2014 American Society of Hematology / American Society of Clinical Oncology Hematology and Oncology Carrier Advisory Committee (CAC) Network Meeting July 24 – 25, 2014 CAC Networking Reception
6:00 – 7:30 p.m. CAC Network Meeting
8:00 a.m – 3:00 p.m American Society of Hematology Headquarters 2021 L Street, NW, 10th Floor Conference Center Washington, DC 20036 202‐776‐0544 2014 ASH/ASCO Carrier Advisory Committee (CAC) Networking Meeting Agenda Friday, July 25, 2014 8:00 AM – 3:00 PM ET 7:30 AM Breakfast 11:15 AM 8:00 AM Welcome and Introductions Steven Allen, MD ASH Co‐Chair Richard McGee, MD ASCO Co‐Chair Open Forum Steven Allen, MD ASH Co‐Chair Richard McGee, MD ASCO Co‐Chair 12:15 PM Lunch 8:15 AM The Attack of The MAC and The RAC Arthur Lurvey, MD Noridian Administrative Services 12:45 PM The State of Molecular Testing 8:45 AM Question and answer session Part I: Molecular Diagnostics and Therapeutics in the Post‐genomic Era Jordan Shavit, MD University of Michigan 8:55 AM Clinical Trials: Medicare, MSP, ACA, and Other Issues to Complicate Our Lives Samuel Silver, MD ASH Co‐Chair 1:30 PM Part II: Medicare Coverage of Genomic Testing: Finding Clinical Unity Louis Jacques, MD ADVI Molecular Testing question and answer session 9:25 AM Question and answer session 2:15 PM 9:35 AM Transition to ICD‐10 Richard Whitten, MD Noridian Administrative Services 2:45 PM 9:55 AM Question and answer session 10:05 AM Morning break 10:15 AM Payment Reform – What is Really Coming Down the Pike John Cox, DO Texas Society of Clinical Oncology Steven Allen, MD North Shore‐LIJ Cancer Institute Richard Whitten, MD Noridian Administrative Services Brian Whitman ASH Meeting Wrap‐up Drs. Allen and McGee CAC Meeting Co‐Chairs 
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3:00 PM CAC Resources o CMS Resources o ASH Resources o ASCO Resources Meeting Evaluation Meeting Reimbursement Form Adjournment Welcome and Introductions 2014 ASH/ASCO CAC Network Meeting Attendee List Abbreviations APP = ASH Practice Partnership COP = ASH Committee on Practice Heather Allen, MD, FACP CAC Representative 3730 S. Eastern Ave Las Vegas, NV 89169 Phone: 702‐952‐3400 heather.allen@usoncology.com Steven L. Allen, MD ASH CAC Co‐Chair ASH COP Chair ASH RS Member CAC Representative 450 Lakeville Road Lake Success, NY 11042 Phone: 516‐734‐8959 allen@nshs.edu Kaitlyn Antonelli Program Associate, Research Policy Division ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1606 kaitlyn.antonelli@asco.org Karen Beard State Society Executive Director 3330 Cumberland Blvd, Suite 225 Atlanta, GA 30127 Phone: 770‐951‐8427, ext. 215 karen.beard@gasco.us CPC = ASCO Clinical Practice Committee RS = ASH Reimbursement Subcommittee Thomas A. Bensinger, MD ASH RS Member CAC Representative 7525 Greenway Center Drive, Suite 205 Greenbelt, MD 20770 Phone: 301‐982‐9800 tabens67@gmail.com Liam Eamonn Boyle, MD CAC Representative 25 Monument Road, Suite 294 York, PA 17403 Phone: 717‐741‐8211 liameboyle@gmail.com Patricia Braly, MD ASCO CPC Member 606 W 12th Avenue Covington, LA 70433 Phone: 985‐892‐2252 pbraly@womenscc.com Suanna Bruinooge Director, Research Policy Division ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1613 Suanna.Bruinooge@asco.org 1
Mitchell Burken, MD Contractor Medical Director Novitas Solutions 2020 Technology Parkway Mechanicsburg, PA 17050 Phone: 410‐891‐5549 mitchell.burken@novitas‐solutions.com Marci Cali Executive Director, ACCC 11600 Nebel Street, Suite 201 Rockville, MD 20852 Phone: 301‐984‐9496 mcali@accc‐cancer.org Robert Cassell, MD Oncology Alternate 3834 Gaines Court, SE Winter Haven, FL 33884 Phone: 863‐292‐4670 rhcassell@gmail.com Paul Celano, MD State Society President 6569 North Charles Street, Suite 200 Baltimore, MD 21204 Phone: 410‐913‐5697 pcelano@gbmc.org Laurence Clark, MD, FACP Contractor Medical Director National Government Services 5000 Brittonfield Parkway, Suite 100 E. Syracuse, NY 13057 Phone: 703‐408‐1442 laurence.clark@wellpoint.com Allen Cohn, MD CAC Representative 1800 Williams Street, Suite 200 Denver, CO 80218 Phone: 303‐388‐4876 allen.cohn@usoncology.com John V. Cox, DO, MBA, FACP, FASCO ASCO CPC Member CAC Representative 1200 Main Street, Suite 2410 Dallas, TX 75202 Phone: 214‐668‐2532 john.cox@usoncology.com Joseph DiBenedetto, Jr., MD State Society President CAC Representative 193 Waterman Street Providence, RI 02906 Phone: 401‐351‐4470 joedibenedetto@msn.com Chancellor Donald, MD CAC Representative 600 Richland Avenue Lafayette, LA 70508 Phone: 337‐258‐6932 chancellordonald@hotmail.com Sukumar Ethirajan, MD State Society President ASCO CPC Member CAC Representative 12140 Nall Avenue, Suite 200 Overland Park, KS 66209 Phone: 913‐498‐7409 sukumar.ethirajan@hcahealthcare.com Omar Eton, MD ASCO CPC Member State Society President 830 Harrison Avenue, Suite 3200 Boston, MA 02118 Phone: 617‐638‐6428 omar.eton@bmc.org 2
Stuart Feldman, MD ASH RS Member 210 Westchester Avenue White Plains, NY 10604 Phone: 914‐681‐5200 sfeldman@westmedgroup.com Paul Fishkin, MD ASH COP Member 8940 N. Wood Sage Rd. Peoria, IL 61615 Phone: 309‐243‐3000 pfishkin@illinoiscancercare.com Annette Fontaine, MD, MBA Oncology Alternate 4901 Lang Avenue, NE Albuquerque, NM 87109 Phone: 505‐264‐3912 afontaine@nmohc.com James Gajewski, MD ASH RS Member CAC Representative 3181 SW Sam Jackson Park Road Portland, OR 97239 Phone: 503‐494‐4606 gajewski@ohsu.edu Matthew Gertzog Deputy Executive Director ASH 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐776‐0544 mgertzog@hematology.org Jose L. Gonzalez State Society Executive Director PO Box 151109 San Rafael, CA 94915 Phone: 415‐472‐3960 execdir@anco‐online.org Dorothy Green Phillips State Society Executive Director 10022 Water Works Lane Riverview, FL 33578 Phone: 813‐677‐0146, ext. 102 dorothy.green@flasco.org Xylina Gregg, MD CAC Representative 3838 South 700 East, Suite 100 Salt Lake City, UT 84106 Phone: 801‐269‐0231 xgregg@utahcancer.com Leonard T. Heffner, MD APP Member CAC Representative 1365 Clifton Road NE, Suite C1152 Atlanta, GA 30322 Phone: 404‐778‐3469 lheffne@emory.edu John E. Hennessy, CMPE ASCO CPC Practice Administrators Workgroup Co‐Chair 903 E 104th Street, Suite 500 Kansas City, MO 64131 Phone: 913‐907‐7605 john.hennesy@sarahcannon.com 3
Allison Hirschorn Coding, Billing, and Reimbursement Specialist ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1653 allison.hirschorn@asco.org Andrew A. Hertler, MD, FACP ASCO CPC Member 80 William Street, Suite 270 Wellesley, MD 02184 Phone: 888‐999‐7713 ahertler@newcenturyhealth.com Dawn Holcombe State Society Executive Director 33 Woodmar Circle South Windsor, CT 06074 Phone: 860‐305‐4510 dawnho@aol.com Elaine Jeter, MD Contractor Medical Director Palmetto GBA P.O. Box 100238, AG‐315 Columbia, SC 29202 Phone: ‐803‐462‐2652 elaine.jeter@palmettogba.com Stephanie Kaplan Government Relations and Practice Manager ASH 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐292‐0263 skaplan@hematology.org Ahmed Khalid, MD State Society Vice President CAC Representative 3100 MacCorkle Avenue, Suite 205 Charleston, WV 25304 Phone: 304‐388‐8379 ahmed.khalid@camc.org Todd Kliewer, MD CAC Representative 230 North Midwest Blvd. Midwest City, OK 73110 Phone: 405‐737‐8455 toddklev@cox.net Mary Klix, MD State Society President 12855 N Forty Drive, Suite 200 St. Louis, MO, 63141 Phone: 314‐523‐5400 mary.klix@usoncology.com Suzanne Leous, MPA Director, Government Relations, Practice, and Scientific Affairs ASH 2021 L Street NW, Suite 900, Washington, DC 20036 Phone: 202‐292‐0258 sleous@hematology.org Martha Liggett, Esq. Executive Director ASH 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐776‐0544 mliggett@hematology.org 4
Arthur N. Lurvey, MD, FACP, FACE Contractor Medical Director Noridian Healthcare Solutions 900 42nd Street S, P.O. Box 6740 F Fargo, ND 58103 Phone: 701‐715‐9583 arthur.lurvey@noridian.com Gary MacVicar, MD Oncology CAC Representative 8940 North Wood Sage Road Peoria, IL 61615 Phone: 309‐243‐3000 gmacvicar@illinoiscancercare.com Mary Malloy, CAE State Society Executive Director 3630 Rockingham Road Royal Oak, MI 48073 Phone: 248‐549‐1440 mmalloy@msho.org Richard McGee, MD ASCO CAC Co‐Chair CAC Representative 809 Hemlock Way Edmonds, WA 98020 Phone: 425‐327‐3537 richardmcgeemd@gmail.com Mohan Menon, MD CAC Representative 85 Seymour Street, Suite 1019 Hartford, CT 06106 Phone: 860‐246‐6647 mmenon33@hotmail.com Charles F. Miller, MD State Society President 762 Kaulana Place Honolulu, HI Phone: 808‐561‐6014 millerc003@hawaii.rr.com Daniel P. Mirda, MD State Society President 1100 Trancas Street, Suite 256 Napa, CA 94558 Phone: 707‐694‐2073 dmirda@rrmg.com Joseph M. Navone, MD State Society President 5008 Brittonfield Parkway East Syracuse, NY 13057 Phone: 315‐263‐7584 jnavone@hoacny.com Deon Nelson Policy and Practice Coordinator ASH 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐292‐0252 dnelson@hematology.org Mark S. Pascal, MD CAC Representative 92 Second Street Hackensack, NJ 07601 Phone: 551‐996‐5900 mpascal@hackensackumc.org
Taral Patel, MD CAC Representative 3100 Plaza Properties Blvd. Columbus, OH 43219 Phone: 614‐565‐2966 tpatel@zangcenter.com Debra Patterson, MD Contractor Medical Director Novitas Solutions 2020 Technology Parkway Mechanicsburg, PA 17050 Phone: 214‐273‐7004 (Gloria Garcia) debra.patterson@novitas‐solutions.com 5
Luis Pineda, MD, MSHA CAC Representative PO Box 530625 Birmingham, AL 35253 Phone: 205‐978‐3568 gina@luisfpinedamdpc.com Robert Plovnick, MD Director of Quality Improvement Programs ASH 2021 L Street, NW, Suite 900 Washington, DC 20036 Phone: 202‐629‐5081 rplovnick@hematology.org David H. Regan, MD, FASCO ASCO CPC Member CAC Representative 5050 NE Hoyt Street, Suite 256 Portland, OR 97034 Phone: 503‐239‐7767 david.regan@usoncology.com Melissa Reifler Program Administrator, State/Regional Affiliate Program ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22318 Phone: 571‐483‐1622 Melissa.Reifler@asco.org Ellen Riker Senior Vice President, CRD Associates 600 Maryland Avenue, SW, Suite 835W Washington, DC 20024 Phone: 202‐484‐1100 eriker@dc‐crd.com Joel Saltzman, MD ASCO CPC Member 9485 Mentor Avenue, Suite 3 Mentor, OH 44122 Phone: 216‐789‐5758 jns70@yahoo.com Federico Sanchez, MD State Society President CAC Representative N14 W23833 Stone Ridge Dr., Suite 200 Waukesha, WI 53188 Phone: 262‐513‐2033 federico.sanchez@aurora.org Juan L. Schaening, MD Contractor Medical Director PO BOX 363628 San Juan PR 00936 Phone: 787‐749‐4144 jschaening@triples‐med.org Rahul Seth, DO CAC Representative 750 E Adams Street Syracuse, NY 13210 Phone: 631‐456‐1346 drrahulseth@gmail.com Jordan Shavit, MD, PhD Guest Presenter 8301 MSRB 3 Ann Arbor, MI 48109 Phone: 734‐647‐4365 jshavit@umich.edu 6
Samuel M. Silver, MD, PhD, MACP, FASCO ASH CAC Co‐Chair ASH COP Member ASH RS Member ASCO CPC Member 4107 Medical Science 1 1301 Catherine St, SPC 5624 Ann Arbor, MI 48109‐5843 Phone: 734‐764‐2204 msilver@umich.edu Jon Strasser, MD State Society President 4701 Ogletown Stanton Rd., Suite 1110 Newark, DE 19713 Phone: 302‐463‐8464 jstrasser@christianacare.org Latha Subramanian, MD State Society President CAC Representative 4231 Lake Otis Parkway, Suite B‐2 Anchorage, AK Phone: 907‐569‐2627 2006anch@gmail.com Monica Tan Program Coordinator ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1671 monica.tan@asco.org Tammy Thiel State Society Executive Director 2741 DeBarr Rd., Suite 300 Anchorage, AL 99308 Phone: 907‐257‐9803 tammy@hotsheet.com Julia Tomkins Senior Program Manager ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1651 julia.tomkins@asco.org Laura Trent Program Associate ASCO 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1671 laura.trent@asco.org Venu Thirukonda, MD State Society President 801 N 29th Street Billings, MT 59101 Phone: 718‐920‐4826 vthirukonda@billingsclinic.org Joseph Uberti, MD, PhD State Society President 4100 John R, MailCode HW04HO Detroit, MI 48201 Phone: 313‐576‐8760 ubertij@karmanos.org Sabina R. Wallach, MD, FRACP, FACP ASH RC Member CAC Representative 9850 Genesee Avenue, Suite 400 La Jolla, CA 92037 Phone: 858‐558‐8666 swallachmd@oncologylajolla.com 7
Tracey F. Weisberg, MD State Society President CAC Representative 100 Campus Drive, Suite 100 Scarborough, ME 04074 Phone: 207‐396‐7600 weisbt@mccm.org Brian Whitman Senior Manager, Policy and Practice ASH 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐292‐0264 bwhitman@hematology.org Richard Whitten, MD, MBA, FACP Contractor Medical Director Noridian Healthcare Solutions 900 42nd St South Fargo, ND 58103 Phone: 206‐979‐5007 dick.whitten@noridian.com Eric T. Wong, MD CAC Representative 330 Brookline Ave, TCC 8 Boston, MA 02215 Phone: 617‐667‐1665 ewong@bidmc.harvard.edu Kim Woofter ASCO CPC Member 3975 William Richardson Drive South Bend, IN 46628 Phone: 574‐204‐7709 kwoofter@mhopc.com Timothy Wozniak, MD CAC Representative 4701 Ogletown Stanton Rd., Suite 2400 Newark, DE 19713 Phone: 302‐731‐7782 tfwmd@aol.com Tammy H. Young, MD CAC Representative 1227 N State St., Suite 101 Jackson, MS 39202 Phone: 601‐953‐4821 tammyyoungmd@yahoo.com Robin T. Zon, MD, FACP, FASCO ASCO CAC Co‐Chair ASCO CPC Chair 615 N Michigan Street South Bend, IN 46601 Phone: 574‐204‐7776 docrzon@aol.com 8
2014 CAC Representative List Alabama (J 10/Region J) Arizona (J 3/Region F) Luis Pineda, MD, MSHA Hematology CAC Representative PO Box 530625 Birmingham, AL 35253 Phone: 205‐978‐3568 gina@luisfpinedamdpc.com John Reardon, MD Oncology CAC Representative 4145 Carmichael Rd Montgomery, AL 36106 Phone: 334‐273‐7000 jreardon@aollc.com Jerry Olshan, MD Oncology CAC Representative 3411 N 5th Ave, Suite 400 Phoenix, AZ 85013 Phone: 623‐879‐6034 jolshan@southwestoncology.com Albert Wendt, MD Oncology CAC Alternate 3411 N. 5TH Ave, Suite 400 Phoenix, AZ 85013 Phone: 602‐248‐0448 awendt@oncdocs.com Alaska (J 2/Region F) Arkansas (J 7 /Region H) Latha Subramanian, MD Hematology CAC Representative Oncology CAC Representative 4231 Lake Otis Parkway, Suite B‐2 Anchorage, AK 99508 Phone: 907‐569‐2627 2006anch@gmail.com Mary Stewart, MD Oncology CAC Alternate 2741 DeBarr Rd Suite C405 Anchorage, AK 99508 Phone: 907‐279‐3155 mstewartonc@yahoo.com Daniel Bradford, MD Hematology CAC Alternate 3232 North Hills Blvd Fayetteville, AR 72703 Phone: 479‐587‐1700 dbradford@hogonc.com Greg Oakhill, MD Hematology CAC Representative 3232 North Hills Blvd Fayetteville, AR 72703 Phone: 479‐587‐1700 gohog@hogonc.com California (J 1/Region E) Ravi Patel, MD Oncology CAC Representative 6501Truxtun Avenue Bakersfield, CA 93309 Phone: 661‐322‐2206 ravi@cbccusa.com 1
Robert Robles, MD Oncology CAC Representative 400 Taylor Blvd, Suite 202 Pleasant Hill, CA 94523 Phone: 925‐677‐5041 rrobles@dvohmg.com Sabina R. Wallach, MD, FRACP, FACP Hematology CAC Representative Oncology Alternate 9850 Genesee Avenue, Suite 400 La Jolla, CA 92037 Phone: 858‐558‐8666 swallachmd@oncologylajolla.com Colorado (J 4/Region H) Allen Cohn, MD Oncology CAC Representative 1800 Williams St Denver, CO 80218 Phone: 303‐886‐8611 allen.cohn@usoncology.com W. Eng Lee, MD Hematology CAC Representative 9451 Huron St Thornton, CO 80260 Phone: 303‐650‐4042 hematology‐oncology@msn.com Connecticut (J 13/Region K) Joseph O'Connell, MD Hematology CAC Representative 40 Commerce Park Milford, CT 06460 Phone: 203‐882‐9608 joc309@aol.com Andrea Ruskin, MD Hematology CAC Alternate 40 Cross St Norwalk, CT 06851 Phone: 203‐845‐2138 andrea@ruskin.net Delaware (J 12/Region L) Jamal Misleh, MD Hematology CAC Representative 4701 Ogletown‐Stanton Rd, Suite 3400 Newark, DE 19713 Phone: 302‐366‐1200 jmisleh@cbg.org Kathir Suppiah, MD Oncology CAC Alternate 4701 Ogletown‐Stanton Rd, Suite 3400 Newark, DE 19713 Phone: 302‐366‐1200 kathirsuppiah@gmail.com Timothy Wozniack, MD Oncology CAC Representative 4701 Ogletown‐Stanton Rd, Suite 2400 Newark, DE 19713 Phone: 302‐731‐7782 tfwmd@aol.com Florida (J 9/Region N) Robert Cassell, MD, PhD Oncology CAC Alternate 200 Ave F NE Winter Haven, FL 33881 Phone: 863‐292‐4670 rcassell@pol.net 2
William Harwin, MD Hematology CAC Representative 15681 New Hampshire Ct Fort Myers, FL 33908 Phone: 941‐437‐4444 wharwin@gmail.com Thomas Marsland, MD Oncology CAC Representative 2161 Kingsley Ave, Suite 200 Orange Park, FL 32073 Phone: 904‐272‐3139 thomas.marsland@foa.cc Georgia (J 10/Region J) Leonard Heffner, MD Hematology CAC Representative Oncology CAC Representative 1365 Clifton Road NE, Suite C1152 Atlanta, GA 30322 Phone: 404‐778‐3469 lheffne@emory.edu Hawaii (J 1/Region E) Jon Fukomoto, MD Hematology CAC Alternate 1329 Lusitana St, Suite 307 Honolulu, HI 96813 Phone: 808‐528‐1711 j.fukumoto.1@alumni.nyu.edu William Loui, MD Hematology CAC Representative Oncology CAC Representative 1329 Lusitana St, Suite 307 Honolulu, HI 96813 Phone: 808‐524‐6115 wsloui@yahoo.com Leaton Pang, MD, MPH, FACR Hematology CAC Representative LPangLRO@aol.com Idaho (J 2/Region F) Dane Dickson, MD Hematology CAC Representative Oncology CAC Representative 380 Walker Dr Rexburg, ID 83440 Phone: 208‐313‐0649 danejdickson@gmail.com Paul Montgomery, MD Oncology CAC Representative 100 E. Idaho St Boise, ID 83712 Phone: 208‐381‐2711 p_kmontgomery@msn.com Illinois (J 6/Region G) Walter Fried, MD Hematology CAC Representative 1700 Luther Lane, Ground Floor Park Ridge, IL 60068 Phone: 847‐268‐8200 fried_walt@hotmail.com Gary MacVicar, MD Oncology CAC Representative 8940 North Wood Sage Road Peoria, IL 61615 Phone: 309‐243‐3000 gmacvicar@illinoiscancercare.com 3
Indiana (J 8/Region I) Kentucky (J 15/Region I) Keith Logie, MD Hematology CAC Representative 10212 Lantern Rd Fishers, IN 46037 Phone: 317‐678‐2700 keith.logie@usoncology.com Renato LaRocca, MD Hematology CAC Representative Oncology CAC Representative 315 East Liberty St, 4th Floor Louisville, KY 40202 Phone: 502‐561‐8200 rvl@kci.us Iowa (J 5/Region G) George Kovach, MD Hematology CAC Representative 1351 West Central Park, Suite 3100 Davenport, IA 52804 Phone: 563‐421‐1960 gkovach@iacancer.com Roscoe Morton, MD Oncology CAC Representative 1221 Pleasant St, Suite 100 Des Moines, IA 50309 Phone: 515‐282‐2921 morton.roscoe@gmail.com Kansas (J 5/Region G) Sukumar Ethirajan, MD Hematology CAC Representative Oncology CAC Representative 12140 Nall Avenue, Suite 200 Overland Park, KS 66209 Phone: 913‐498‐7409 sukumar.ethirajan@hcahealthcare.com Dennis Moore, MD Hematology CAC Representative 818 North Emporia, Suite 403 Wichita, KS 67214 Phone: 316‐262‐4467 dennis.moorejr@cancercenterofkansas.
com Louisiana (J 7/Region G) Chancellor Donald, MD Hematology CAC Representative 600 Richland Avenue Lafayette, LA 70508 Phone: 337‐258‐6932 chancellordonald@hotmail.com David Oubre, MD Oncology CAC Representative 120 Lakeview Cir Covington, LA 70433 Phone: 985‐875‐1202 dnounre@bellsouth.net Howard Wold, MD Oncology CAC Representative 605 B Medical Center Dr Alexandria, LA 71301 Phone: 318‐442‐2232 hwold@holcmed.com Maine (J 14/Region K) Tracey Weisberg, MD Oncology CAC Representative 100 Campus Drive, Suite 100 Scarborough, ME 04074 Phone: 207‐396‐7600 weisbt@mccm.org 4
Maryland (J 12/Region L) Minnesota (J 6/Region G) Thomas Bensinger, MD ASH RS Member Hematology CAC Representative 7525 Greenway Center Drive, Suite 205 Greenbelt, MD 20770 Phone: 301‐982‐9800 tabens67@gmail.com Joseph Leach, MD Oncology CAC Representative 910 E 26th St, Suite 200 Minneapolis, MN 55404 Phone: 612‐884‐6300 Joseph.leach@usoncology.com Burton Schwartz, MD Hematology CAC Representative 800 E 28th St, Suite 405 Minneapolis, MN 55407 Phone: 612‐863‐8585 burton.schwartz@usoncology.com Mark Wilkowske, MD Hematology CAC Representative 3931 Louisiana Ave N St. Louis Park, MN 55426 Phone: 952‐993‐3248 wilkom@parknicollet.com Massachusetts (J 14/Region K) Michael Constantine, MD Hematology CAC Representative 20 Prospect St Milford, MA 01757 Phone: 508‐488‐3700 mconstantine@milreg.org Eric Wong, MD Oncology CAC Representative 330 Brookline Ave Boston, MA 02215 Phone: 617‐667‐1665 ewong@bidmc.harvard.edu Michigan (J 8/Region I) Paul Adams, MD Hematology CAC Representative 301 Kensington, Suite 113 Flint, MI 48503 Phone: 801‐762‐8226 pta@genesys.org Mississippi (J 7/Region H) Stephanie Elkins, MD Hematology CAC Representative 2500 North State St Jackson, MS 39216 Phone: 601‐981‐5619 selkins@umc.edu David Morris, MD Oncology CAC Representative 103 Asbury Cir Hattiesburg, MS 39402 Phone: 601‐268‐5150 vidmorris@hotmail.com 5
Tammy Young, MD Oncology CAC Representative 1227 N State St., Suite 101 Jackson, MS 39202 Phone: 601‐953‐4821 ttyoung@earthlink.net Missouri (J 5/Region G) Joseph Muscato, MD, FACP Oncology CAC Representative 1705 E Broadway, Suite 100 Columbia, MO 65201 Phone: 573‐874‐7800 joseph.muscato@usoncology.com Burton Needles, MD Hematology CAC Representative 607 S New Ballas St. Louis, MO 63141 Phone: 314‐251‐4400 burton.needles@mercy.net Montana (J 3/Region F) None Listed Nebraska (J 5/Region G) Margaret Block, MD Hematology CAC Representative 77710 Mercy Rd, Suite 122 Omaha, NE 68124 Phone: 402‐393‐3110 mblock@nebraskacancer.com Robert Langdon, MD Oncology CAC Representative 8303 Dodge St, Suite 250 Omaha, NE 68114 Phone: 402‐354‐8214 rlangdon@nebraskacancer.com Nevada (J 1/Region E) Heather Allen, MD, FACP Hematology CAC Representative Oncology CAC Representative 3730 S. Eastern Ave Las Vegas, NV 89169 Phone: 702‐952‐3400 heather.allen@usoncology.com Dan Curtis, MD Oncology CAC Alternate 655 Town Center Dr Las Vegas, NV 89144 Phone: 702‐233‐2200 dan.curtis@usoncology.com New Hampshire (J 14/Region K) Fred Briccetti, MD Oncology CAC Alternate 200 Technology Dr Hooksett, NH 03106 Phone: 603‐622‐6484 f.briccetti@nhoh.com Steve Larmon, MD Hematology CAC Representative Oncology CAC Representative 590 Court St Keene, NH 03431 Phone: 603‐354‐5465 Steven.S.Larmon@Hitchcock.org New Jersey (J 12/Region L) Mark S. Pascal, MD Hematology CAC Representative 92 Second Street Hackensack, NJ 07601 Phone: 551‐996‐5900 mpascal@hackensackumc.org 6
Kevin Callahan, MD Oncology CAC Representative 1930 NJ 70 East, Suite V107 Cherry Hill, NJ 08003 Phone: 856‐424‐3311 kcallahan@centerforcancer.com New Mexico (J 4/Region H) Annette Fontaine, MD, MBA Oncology CAC Alternate 4901 Lang Avenue, NE Albuquerque, NM 87109 Phone: 505‐264‐3912 afontaine@nmohc.com Barbara McAneny, MD, FACP Hematology CAC Alternate 4901 Lang NE Albuquerque, NM 87109 Phone: 505‐842‐8171 mcaneny@nmohc.com New York (J 13/Region K) Steven L. Allen, MD Hematology CAC Representative Oncology CAC Representative 450 Lakeville Road Lake Success, NY 11042 Phone: 516‐734‐8959 allen@nshs.edu Rahul Seth, MD Oncology CAC Representative 750 E Adams Street Syracuse, NY 13210 Phone: 631‐456‐1346 drrahulseth@gmail.com Thomas Goodman, MD Hematology CAC Representative 1101 Nott St Schenectady, NY 12308 Phone: 518‐243‐4434 drsgood@nycap.rr.com Michael Willen, MD Oncology CAC Representative 1003 Loudon Rd Latham, NY 12047 Phone: 518‐786‐3122 Michael.willen@usoncology.org North Carolina (J 11/Region M) James Boyd, MD Hematology CAC Representative 2711 Randolph Rd, Bldg 100 Charlotte, NC 28207 Phone: 704‐342‐1900 jfboyd@oncologycharlotte.com David Eagle, MD Oncology CAC Representative 170 Medical Park Rd, Suite 101 Mooresville, NC 28117 Phone: 704‐779‐3946 deagle@lnho.org North Dakota (J 3/Region F) Ralph Levitt, MD Hematology CAC Representative 820 4th St N Fargo, ND 58102 Phone: 701‐234‐6161 ralph.levitt@sanfordhealth.org 7
Ohio (J 15/Region I) Scott Blair, MD Hematology CAC Alternate 810 Jasonway Ave, Suite A Columbus, OH 43214 Phone: 613‐442‐3130 sblair@coainc.cc Christopher George, MD Oncology CAC Alternate 810 Jasonway Ave Columbus, OH 43214 Phone: 614‐442‐3130 cgeorge@coainc.cc David Kirlin, MD Oncology CAC Representative 4350 Malsbary Rd, Suite 100 Cincinnati, OH 45242 Phone: 513‐891‐4800 dkirlin@ohcare.com Taral Patel, MD Hematology CAC Representative 3100 Plaza Properties Blvd. Columbus, OH 43219 Phone: 614‐565‐2966 tpatel@zangcenter.com Oklahoma (J 4/Region H) John Eckenrode, MD Oncology CAC Representative 1705 E 19th St, Suite 201 Tulsa, OK 74104 Phone: 918‐744‐3180 eckenrode@oklahoma‐oncology.com Todd Kliewer, MD Hematology CAC Representative Oncology CAC Representative 230 North Midwest Blvd. Midwest City, OK 73110 Phone: 405‐737‐8455 toddklev@cox.net Oregon (J 2/Region F) James Gajewski, MD Hematology CAC Representative Oncology CAC Alternate 3181 SW Sam Jackson Park Road Portland, OR 97239 Phone: 503‐494‐4606 gajewski@ohsu.edu David H. Regan, MD, FASCO Hematology CAC Representative Oncology CAC Representative 5050 NE Hoyt Street, Suite 256 Portland, OR 97034 Phone: 503‐239‐7767 david.regan@usoncology.com Pennsylvania (J 12/Region L) Eamonn Boyle, MD Oncology CAC Representative 2020 Knights View Rd Wrightsville, PA 17368 Phone: 717‐741‐9229 lebsvb@aol.com Raymond Vivacqua, MD Oncology CAC Alternate 1 Medical Center Blvd Upland, PA 19013 Phone: 610‐876‐6923 rdwplt@comcast.net 8
Rhode Island (J 14/Region K) Texas (J 4/Region H) Joseph DiBenedetto Jr., MD Hematology CAC Representative 193 Waterman Street Providence, RI 02906 Phone: 401‐351‐4470 joedibenedetto@msn.com John Cox, DO, MBA, FACP, FASCO Oncology CAC Representative 1200 Main Street, Suite 2410 Dallas, TX 75202 Phone: 214‐668‐2532 John.Cox@usoncology.com David Gordon, MD Hematology CAC Representative 540 Madison Oak, Suite 200 San Antonio, TX 78258 Phone: 210‐545‐6972 david.gordon@usoncology.com Roger Lyons, MD Hematology CAC Alternate 4411 Medical Dr, Suite 100 San Antonio, TX 78229 Phone: 210‐595‐5300 roger.lyons@usoncology.com South Carolina (J 11/Region M) Kashyap Patel, MD Oncology CAC Representative 1583 Health Care Dr Rock Hill, SC 29732 Phone: 803‐329‐7772 kpatel@cbcca.net South Dakota (J 3/Region F) Loren Tschetter, MD Hematology CAC Representative 1020 West 18th St Sioux Falls, SD 57104 Phone: 605‐328‐8000 ltschetter@pol.net Tennessee (J 10/Region J) Charles McKay, MD Hematology CAC Representative 397 Wallace Rd Nashville, TN 37211 Phone: 615‐333‐2481 capeeland@aol.com Charles Penley, MD Oncology CAC Representative 300 20th Ave N, Suite 301 Nashville, TN 37203 Phone: 615‐329‐0570 cpenley@tnonc.com Utah (J 3/Region F) Wendy Breyer, MD Oncology CAC Representative 1152 East 200 North American Fork, UT 84003 Phone: 801‐772‐0698 wbreyer@centralutahclinic.com Xylina Gregg, MD Hematology CAC Representative 3838 South 700 East, Suite 100 Salt Lake City, UT 84106 Phone: 801‐269‐0231 xgregg@utahcancer.com 9
Vermont (J 14/Region K) Christian Thomas, MD Hematology CAC Representative 792 College Pkway, Suite 207 Colchester, VT 05446 Phone: 802‐655‐3400 christian.thomas@vtmednet.org H. James Wallace, MD Rad Oncology CAC Representative 792 College Pkway, Suite 207 Colchester, VT 05446 Phone: 802‐847‐3506 James.Wallace@htmednet.org Virginia (J 11/Region M) Richard Ingram, MD Hematology CAC Alternate 420 Glen Lea Ct Winchester, VA 22601 Phone: 504‐974‐7845 laurenmiadad@gmail.com James May, III, MD Oncology CAC Representative 1401 Johnston‐Willis Dr, Suite 4200 Richmond, VA 23235 Phone: 804‐330‐7990 jmay@vacancer.com Washington (J 2/Region F) Richard McGee, MD Hematology CAC Representative Oncology CAC Representative 809 Hemlock Way Edmonds, WA 98020 Phone: 425‐327‐3537 richard.mcgee@swedish.org Jeffery Ward, MD, FASCO Oncology CAC Alternate 21632 Highway 99 Edmonds, WA 98025 Phone: 425‐775‐1677 jeffery.ward@swedish.org West Virginia (J 11/Region M) Ahmed Khalid, MD Hematology CAC Representative Oncology CAC Representative 3100 MacCorkle Avenue, Suite 205 Charleston, WV 25304 Phone: 304‐388‐8379 ahmed.khalid@camc.org James Frame, MD, FACP Hematology CAC Alternate 3100 MacCorkle Avenue SE, Suite 101 Charleston, WV 25304 Phone: 304‐388‐8380 james.frame@camc.org Gerril Kimmey, MD Hematology CAC Representative 5170 RT 60 East Huntington, WV 25705 Phone: 304‐528‐4645 kimmey@uhswv.com Arvind Shah, MD Oncology CAC Representative 401 Division St, Suite 100 South Charleston, WV 25309 Phone: 304‐766‐4350 ashah2733@gmail.com 10
Wisconsin (J 6/Region G) Federico Sanchez, MD Oncology CAC Representative N14 W23833 Stone Ridge Dr., Suite 200 Waukesha, WI 53188 Phone: 262‐513‐2033 federico.sanchez@aurora.org Jacob Frick, MD Oncology CAC Alternate 2801 W Kinnickinnic River Pkwy Milwaukee, WI 53215 Phone: 414‐384‐5111 jacob.frick@aurora.org William Mathaeus, MD Oncology CAC Representative 1055 N. Mayfair Rd Wauwatosa, WI 53226 Phone: 414‐476‐8450 wmatthaeus@ah.com Douglas Reding, MD Hematology CAC Representative 1000 North Oak Ave Marshfield, WI 54449 Phone: 715‐387‐5134 reding@mfldclin.edu Wyoming (J 3/Region F) Mohammed Mazhur‐Uddin, MD Hematology CAC Representative 1111 Logan Ave Cheyenne, WY 82001 Phone: 307‐635‐9131 11
2014 Contractor Medical Directors Olatokunbo Awodele, MD, MPH CMD: J‐5 Wisconsin Physician Services Corp 333 Farnam Street Omaha, NE 68131 olatokunbo@wpsic.com Earl Berman FACP, MALPS‐L CMD: J15 Part B CGS Administrators, LLC Two Vantage Way Nashville, TN 37228 earl.berman@cgsadmin.com Stephen Boren MD, MBA CMD: J13 & J6 National Government Services 5000 Brittonfield Pkway, Suite 100 East Syracuse, NY 13057 stephen.boren@wellpoint.com Mitchell Burken, MD CMD: JH/J12 Novitas Solutions, Inc 2020 Techology Parkway Mechanicsburg, PA 17050 mitchell.burken@novitas‐solutions.com RaeAnn G. Capehart, MD CMD: JH/JL Novitas Solutions, INC 2020 Techology Parkway Mechanicsburg, PA 17050 raeann.capehart@novitas‐
solutions.com Laurence Clark, MD, FACP CMD: J13 & J6 National Government Services 5000 Brittonfield Pkway, Suite 100 East Syracuse, NY 13057 laurence.clark@wellpoint.com James Corcoran, MD, MPH CMD: J9 A/B MAC First Coast Service Option, Inc. 532 Riverside Avenue 20T Jacksonville, FL 32202 james.corcoran@fcso.com Harry Feliciano, MD, MPH CMD: J11 MAC Palmetto GBA P.O. Box 100238, AG‐275 Columbia, SC 29202 harry.feliciano@palmettogba.com Atul Goel, MD CMD: J11 MAC Palmetto GBA P.O. Box 100238, AG‐275 Columbia, SC 29202 atul.goal@palmettogba.com Anitra Graves, MD CMD: J10 MAC Cahaba GBA PO Box 13384 Birmingham, AL 35205 anitra.graves@cahabagba.com Charles Haley, MD, MS, FACP CMD: JF, A/B MAC Noridian Healthcare Solutions 900 42nd Street S, P.O. Box 6740 Fargo, ND 58103 charles.haley@noridian.com Craig Haug, MD CMD: J‐K MAC NHIC, Corp 75 Sgt William B. Terry Drive Hingham, MA 02043 craig.haug@hp.com Sidney Hayes, MD CMD: JH/J12 Novitas Solutions, Inc 2020 Technology Parkway Mechanicsburg, PA 17050 sidney.hayes@novitas‐solutions.com Bernice Hecker, MD, MHA, FACC CMD: JE AB MAC Noridian Healthcare Solutions 900 42nd Street S, P.O. Box 6740 Fargo, ND 58103 bernice.hecker@noridian.com Eddie Humpert, MD, MS CMD: J10 MAC Cahaba GBA P.O. Box 13384 Birmingham AL 35205 edward.humpert@cahabagba.com Elaine Jeter, MD CMD: J11 MAC & MolDx Palmetto GBA P.O. Box 100238, AG‐315 Columbia, SC 29202 Elaine.Jeter@palmettogba.com Robert Kettler, MD CMD: J‐5 Wisconsin Physician Services Corp. 1717 W. Broadway PO Box 1787 Madison, WI 53701 robert.kettler@wpsic.com Arthur Lurvey, MD, FACP, FACE CMD: JE A/B MAC Noridian Healthcare Solutions 900 42nd Street S, P.O. Box 6740 Fargo, ND 58103 Arthur.lurvey@noridian.com Kenneth M Donough, MD CMD: J15 A/B MAC CGS Administrators, LLC Two Vantage Way Nashville, TN 37228 kenneth.mcdonough@cgsadmin.com Gregg McKinney, MD, MBA CMD: J10 MAC Cahaba GBA P.O. Box 13384 Birmingham AL 35205 gmckinney@cahabagba.com Thom Mitchell, MD CMD: J10 MAC Cahaba GBA PO Box 13384 Birmingham, AL 35205 thomas.mitchell@cahabagba.com Michael Montijo, MD, MPH, FACP CMD: J‐15 CGS Administrators, LLC Two Vantage Way Nashville, TN 37228 michael.montijo@cgsadmin.com Ella Noel, MD CMD: J‐8 Wisconsin Physician Services Corp . 1717 W. Broadway PO Box 1787 Madison, WI 53701 ella.noel@wpsic.com Gary Oakes, MD, FAAFP CMD: JF A/B MAC Noridian Healthcare Solutions 900 42nd Street S, P.O. Box 6740 Fargo, ND 58103 gary.oakes@noridian.com Debra Patterson, MD CMD: JH/JL Novitas Solutions, Inc. 2020 Technology Parkway Mechanicsburg, PA 17050 debra.patterson@novitas‐solutions.com Fred Polsky, MD, FACP CMD: J9 A/B MAC First Coast Service Option, Inc. 532 Riverside Avenue 20T Jacksonville, FL 3220 fred.polsky@FCSO.com Cheryl Ray, DO, MBA, FACN CMD: J‐5 Wisconsin Physician Services Corp 1717 W. Broadway PO Box 1787 Madison, WI 53701 cheryl.ray@wpsic.com Mitchell Resnick, DO CMD: JL/JH Novitas Solutions, Inc. 2020 Technology Parkway Mechanicsburg, PA 17050 mitchell.resnick@novitas‐solutions.com Juan Schaening, MD CMD: J9 MAC (Puerto Rico, USVI, FL) Triple S Salud, Inc. P.O. Box 363628 San Juan, PR 00936 jschaening@triples‐med.org Antonietta Sculimbrene, MD, MHA, RPh CMD: J11 MAC Palmetto GBA P.O. Box 100238 AG‐275 Columbia, SC 29202 antonietta.sculimbrene@palmettogba.c
om John Whitney, MD CMD: J6 National Government Services 8 Dula Place, P.O. Box 778 Bolton Landing, NY 12814 johnwhitneymd@wellpoint.com Richard (Dick) Whitten, MD, MBA, FACP CMD: DME MAC ‐ D Noridian Healthcare Solutions 900 42nd Street South Fargo, ND 58103‐6747 dick.whitten@noridian.com 2014 ASH/ASCO Staff Contact Information Stephanie Kaplan Government Relations and Practice Manager American Society of Hematology 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐776‐0544 skaplan@hematology.org Suzanne M. Leous, MPA Director, Government Relations, Practice and Scientific Affairs American Society of Hematology 2021 L Street, NW, Suite 900 Washington, DC 20036 Phone: 202‐292‐0258 sleous@hematology.org Deon Nelson Policy and Practice Coordinator American Society of Hematology 2021 L Street NW, Suite 900 Washington, DC 20036 Phone: 202‐292‐0252 dnelson@hematology.org Brian Whitman Senior Manager, Policy and Practice American Society of Hematology 2021 L Street, NW, Suite 900 Washington, DC 20036 Phone: 202‐292‐0264 bwhitman@hematology.org Allison Hirschorn Coding and Reimbursement Specialist American Society of Clinical Oncology 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1653 Allison.Hirschorn@asco.org Deborah Kamin, PhD Senior Director, Cancer Policy & Clinical Affairs 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1610 Deborah.Kamin@asco.org Monica Tan Program Coordinator American Society of Clinical Oncology 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1671 Monica.Tan@asco.org Julia Tomkins Senior Program Manager American Society of Clinical Oncology 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1651 Julia.Tomkins@asco.org Laura Trent Program Associate American Society of Clinical Oncology 2318 Mill Road, Suite 800 Alexandria, VA 22314 Phone: 571‐483‐1601 Laura.Trent@asco.org Attack of The MAC and The RAC SHORT BIO: ARTHUR N. LURVEY; MD, FACP, FACE
Arthur Lurvey is a board certified internist and endocrinologist, and has been a
Medicare Contractor Medical Director for 18 years---initially working for the
Medicare carriers: Transamerica Occidental Life Insurance Company, National
Heritage Insurance Company, National Government Services; Palmetto GBA and
most recently for Noridian Healthcare Solutions, the Medicare Contractor in
Jurisdiction JE. He was in clinical practice for 35 years.
Dr. Lurvey received his MD degree from the University of Illinois, and had his
post doctorate and fellowship training at Los Angeles County-USC Medical
Center. He is a Fellow of the American College of Physicians and the American
College of Endocrinology.
He is a delegate to both the California Medical Association and American
Medical Association, has been a past Hospital Chief of Staff and served on
several committees of the Hospital Council of Southern California. He also is on
the Board of the California Region of the American College of Physicians and on
several committees of the American Association of Clinical Endocrinologists.
Other medical activities include service as a CMA surveyor for both the Joint
Commission hospital survey program and the CME accreditation program in
California.
7/11/2014
Healthcare System Changing
• Current system unsustainable…including oncology
• Only thing constant is change—gradual , inevitable
–
–
–
–
ATTACK OF THE MAC AND
THE RAC
ASH – ASCO National CAC Meeting
Washington DC
July 25, 2014-
I’m A Doctor
Care from single doctor to team of docs
Solo to single & multispecialty groups---alone or aligned
New 3 letter words: ACO, VBP, NPP, ACA, etc.
EHR with more documentation than ever before
• Salaried practices, professional management,
practice bonuses, risk sharing arrangements
• Alternate delivery system trials
– Technology driven but problematic with risk management
– Gradual but definite transition over next few years for all
concerned
– Physician need multiple new skills: coding, contracting, IT
& computer, legal, financial, technical---plus keeping up to
date with clinical literature and maintenance of
2
certification….Being ready for what is out there…
RECOVERY AUDITOR (RA) PROGRAM
• Who are they: Companies that contract with
CMS to find improper payments that may
have been made to Medicare providers
• Mission: The Recovery Audit Program’s
mission is to identify and correct Medicare
improper payments through the efficient
detection and collection of overpayments
made on claims of health care services
provided to Medicare beneficiaries, and the
identification of underpayments to providers
so
CMS there
can implement
actions
In that
mostthe
studies
were about
90% that
will prevent future improper payments in all
overpayments
and
10%
underpayments
50 states.
7/11/2014
3
7/11/2014
4
RA Jurisdictions
Jurisdiction
Company
Region A
Region B
Region C
Region D
Performant Recovery
CGI
Connolly, Inc.
Health Data Insights, Inc.
•RAs jurisdictions match the DME jurisdictions
•RAs Perform medical reviews of paid claims.
•They will not review a claim that was previously
reviewed by another entity.
•They may re-review a previously reviewed claim
for another reason
November 2013
5
PERFORMANT
November 2013
CGI
Connolly
HDI
6
1
7/11/2014
The Recovery Audit Review Process
• Recovery Auditors review claims on a postpayment basis
• Recovery Auditors use the same Medicare
policies as MACs: NCDs, LCDs and the CMS
Manuals and other regulations
• Three types of review:
– Automated (no medical record needed)
– Semi-Automated (claims review using data and potential
human review of a medical record or other related
documentation)
– Complex (medical record required)
• Recovery Audits look back three years from the
date the claim was paid
• Recovery Auditors are required to employ a staff
consisting of nurses, therapists, certified coders
and a physician CMD
7/11/2014
7
Rules Regarding Recovery Auditors
• RAs are paid via contingency fees based on
what they collect.
• An RA Validation Contractor has annual
accuracy scores for each RA
• If an RA loses at any level of appeal, the RA
must return its whole contingency fee for
that service
• New Issues and Program Vulnerabilities
posted to the Web site
• Recovery Audit claim status Website
• Detailed Review Results Letter sent
following all Complex Reviews
7/11/2014
9
Rules Regarding Recovery Auditors
• Recovery Auditors offer opportunity
for physicians to discuss improper
payment determination with the
Recovery Auditors (this is outside the
normal appeal process)
• Issues reviewed by the Recovery
Auditor are approved by CMS prior to
widespread review
• MACs can comment on RA selection
topics via contact with CMS
• Approved issues are always posted to
a Recovery Audits Website before
widespread review
7/11/2014
8
Responding To Recovery Auditors
Medical Record Requests
• Tell your RA the precise address and
contact person they should use when
sending Medical Record Request Letters:
• Call RA or Use RA Programs’ Websites
• When necessary, check on the status of
your medical record (Did the Recovery
Auditor receive it?):
– Call Recovery Auditor
– Use Recovery Audit Programs’ Websites
7/11/2014
APPEAL, APPEAL, APPEAL
10
Mad as hell 0:20 or 1:00
• The appeal process for RA denials is
same as for MAC denials.
– MAC, QIC, ALJ, DAB, Federal Court
• Don’t confuse the “RA Audit Programs’
Discussion Period” with the Appeals
process.
• If you disagree with the RA’s
determination:
– Do not stop with sending a discussion
letter, but…
– File an appeal before the 120th day after
the Demand letter.
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2
7/11/2014
Former RA Reviews
RESPOND TO ALL CHART REQUESTS
• Short Inpatient Hospital Stays—medical nec. for number
of minor procedures being treated as inpatient
• PT-OT-SRT over cap amounts
• Initial vs subsequent office/hospital visits
• Out pt dx codes within 3 days of admission
• Various DRG overpayments not supported in chart
Note majority of larger cases were institutional
• Outpatient surgery as inpatient---appendectomy, male
based: hospital inpatient, SNF, hospice or
urology procedures, endocrine procedures, ortho, etc.
outpatient
therapy
claims.
Therenotes,
werecoding
not that
• Hosp.
DRGs not
matching
physician
many
office
or
oncology
services
reviewed
• Procedure add-on codes without primary codes
• Observation codes: admit and D/C same day
• Inappropriate admissions for minor complications
• Hospice svcs related to terminal dx billed separately
• Office visits for hospital inpatients or SNF inpatients
7/11/2014
13
• Who can request chart:
– MAC, RA, CERT, QIC, QIO, patients themselves
– OIG, DOJ, Private Insurance, Attorneys
• Send all requested documents
–
–
–
–
Rewrite/type if illegible…reviewers must read it
Signature full & legible…add signature sheet
Make sure orders/charts signed…attestation
Send within time frame listed--- certified mail
• Call RA within if 15 days for discussion
• Questions call contractor physician contact
center---if not answered ask to be elevated
• Help from local ASH-ASCO-or your State or
7/11/2014
14
County
Medical Society…or your colleague
RESPONDING TO ANY
REQUEST FOR RECORDS
APPEALS PROCESS
• Have a set office process for dealing with all ADRs
(Additional Record Requests)
• Have one individual responsible for sending all
records as part of the set office process
– Experienced office person, or clinical person, or both
• Have a check off sheet that involves
–
–
–
–
–
Legibility (can add typed / printed addendum)
Correct name, date, physician listed in request
Signature (signature sheet or attestation if needed)
Correct address to send records
Timeliness of records being sent
• Know how and where to get hospital records
• Send by certified mail (or equivalent)
APPEALS PROCESS
• Instructions for appeal
comes with any denial
– Time frames for next level
– Addresses for appeal
• No penalty for new appeals
– Fresh person with each
appeal level
– Often higher level review
• Recommend appeals with
CERT, RAC
• Useful to discuss with med
organizations and specialty
societies to see if other
appeals win & why denied
RAC starts with
redetermination
• Initial Determination to
Noridian ($1) 120 days
• Redetermination from
Noridian ($1) 120 days
• Qualified Independent
Contractor ($1) 120 day
• Administrative Law
Judge ($130) 60 days
• Department Appeals
Board (DAB) ($1340)
• Federal Court
There Will Be Winners and Losers
• Be aware of changes in laws / regulations
• Decide on possible practice changes
– Age and practice style of physicians
– Place of practice & lifestyle of physician
• Be on top of billing, coding, appeals
• Be on top of overhead & other costs
– You may have set fees as Medicare
– You may have risk sharing contracts
– Which services make sense in your office
•
•
•
•
Strategic alliances may be good
Check with healthcare attorneys
Beware of consultants—you know more than them
Medicine very different now than at turn of this
century- tools, practice patterns, science, etc.
7/11/2014
Remember the good old days?
3
8/14/2014
Party is over 2:25-3:20
Those were the days 1:46
8/14/2014
19
8/14/2014
20
4
Clinical Trials: Medicare, MSP, ACA and Other Issues Meant to Complicate Our Lives Samuel M. Silver, MD, PhD, MACP, FASCO
Samuel M. Silver, MD, PhD, is Professor of Internal Medicine, in the Division of Hematology/Oncology,
Assistant Dean for Research, and Associate Medical Director for the Faculty Group Practice at the
University of Michigan Medical School. He is chair of the National Comprehensive Cancer Network’s
Board of Directors.
Dr. Silver received his undergraduate degree in Chemistry, summa cum laude, from Brandeis University
in Waltham, Massachusetts, his PhD in Virology from the Rockefeller University, and his medical degree
from Cornell University Medical College. He did his Internal Medicine training at the University of
California, San Francisco and his fellowship in Hematology/Oncology at the University of Pennsylvania.
During his 28 years at the University of Michigan, he has held numerous positions including Medical
Director of the Medical Management Center and Director of Adult Bone Marrow Transplantation.
Dr. Silver has worked as the principal investigator for numerous clinical research studies involving a
range of topics, such as malignant hematology and the quality of oncology care. Throughout his career,
Dr. Silver has focused on issues involving practice and reimbursement and he is recognized nationally for
his involvement in clinical reimbursement and coding. He is a member of the American Society of
Hematology’s Committee on Practice and Chairman of the Subcommittee on Reimbursement. He is a
member of the ASCO Clinical Practice Committee and is past chair of ASCO’s Quality Cancer
Committee. He represents ASH to AMA’s CPT Advisory Committee and is the ASCO alternate to the
AMA RUC. He was previously the Medicare Hematology Carrier Medical Advisor for Michigan. He
previously served as chair of the Board of Directors of the Physician Organization of Michigan.
Dr. Silver established Michigan’s first statewide consortium on quality breast cancer care and received a
Statesman Award from the American Society of Clinical Oncology for his significant volunteer efforts in
2008. He received the Burgess L. Gordon Award from the AMA for his work on the CPT and received
the Exemplary Service Award from the American Society of Hematology. Dr. Silver received the
Laureate Award from the Michigan Chapter of the American College of Physicians in 2014.
Dr. Silver serves on the editorial board of several scientific journals. He is a Master of the American
College of Physicians and a Fellow of both the American Heart Association and the American Society of
Clinical Oncology. He is a member of the American Society for Blood and Marrow Transplantation and
the American Society of Hematology, and served on the Boards of the latter two organizations. He is
Past-President of the Michigan Society of Hematology and Oncology and remains on its Board of
Directors.
7/11/2014
Clinical Trials:
Topic Overview
Medicare, MSP, ACA and
Other Issues Meant to
Complicate Our Lives
• Medicare & Clinical Research
Billing
• Healthcare Reform & Clinical
Trials
• Medicare Advantage Plans
• Medicare Secondary Payer Issues
• The increasing complexity of TPAs
and self-funded companies
2014 ASH/ASCO Carrier Advisory
Meeting
Samuel M Silver, MD, PhD, MACP
Washington, DC
25 July 2014
2
The Current Landscape:
State Laws
The Current Landscape:
Federal Laws
• Presidential Executive Memorandum
for Medicare, 2000
• Medicare, Medicaid and State
Children’s Health Insurance
Program Extension Act (MMSEA),
2007
34 States and the District of Columbia
Have Clinical Trials Coverage Laws or
Agreements, Although Specifics Vary
from State to State
• Patient Protection and Affordable
Care Act (PPACA), 2010
3
Recommendations of National
Academy of Sciences Report,
2000
4
Executive Memorandum
• Medicare should reimburse routine
care for patients in clinical trials in the
same way it reimburses routine care for
patients not in clinical trials.
• President Clinton signed an executive
memorandum on June 7, 2000 directing the
Secretary of Health and Human Services to
“explicitly authorize (Medicare) payment for
routine patient care costs. . .and costs due to
medical complications associated with
participation in clinical trials”.
• Medicare should continue its current
practice of reimbursing costs of treating
conditions that result as unintended
consequences (complications) of
clinical trials.
Source: CMS Transmittal AB-00-89
Source: National Academy of Science, 2000. Extending Medicare
Reimbursement in Clinical Trials.
5
6
1
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Overarching Goals of the
Medicare NCD
Requirements for Clinical
Trial Coverage under CMS
• The trial must evaluate an item or service that
falls within a Medicare benefit category.
• The trial must not be designed exclusively to
test toxicity or disease pathophysiology. It
must have a therapeutic intent (emphasis
added).
• Trials of therapeutic interventions must enroll
patients with diagnosed disease, not healthy
volunteers.
• Trials of diagnostic interventions may enroll
healthy patients as a control group.
• Allow Medicare beneficiaries to participate in
research studies
• Encourage research that adds to the
knowledge base regarding Medicare
population
• Allow Medicare beneficiaries to receive care
that may have a health benefit
7
CMS: Qualified Trials
8
Covered Routine Costs
• Trials that are deemed to be
automatically qualified:
• All items and services that are otherwise
generally available to Medicare beneficiaries,
including:
– Trials funded by NIH, CDC, AHRQ, CMS,
DOD, and VA;
– Trials supported by centers or
cooperative groups that are funded by
NIH, CDC, AHRQ, CMS, DOD, and VA;
– Trials conducted under an
investigational new drug application
(IND) reviewed by the FDA
– An IND exempt drug trial under 21 CFR
312.2(b)(1) will be deemed automatically
qualified until the self-certification
process is in place.
– Those provided absent a clinical trial (e.g.,
conventional care)
– Those required solely for the provision of the
investigational item or service (e.g.,
administration of a non-covered
chemotherapeutic agent)
– Those required for clinically appropriate
monitoring of effects of investigational item or
service, or prevention of complications
– Those needed for reasonable and necessary care,
for diagnosis or treatment of complications
9
What is Not Covered
Coverage with Evidence
Development (CED)
According to the NCD…
• CMS, through its NCD process, may
establish clinical trials to determine
whether certain items and services, for
which there is some evidence of
significant clinical benefit, but for which
there is insufficient evidence to support
a “reasonable and necessary”
determination. Such services are only
reasonable and necessary when
provided in a clinical trial defined in the
NCD.
“Routine costs of a clinical trial include all items and services
that are otherwise generally available to Medicare
beneficiaries (i.e., there exists a benefit category, it is not
statutorily excluded, and there is not a national non-coverage
decision) that are provided in either the experimental or the
control arms of a clinical trial except:
• The investigational item or service, itself unless otherwise
covered outside of the clinical trial;
• Items and services provided solely to satisfy data
collection and analysis needs and that are not used in the
direct clinical management of the patient (e.g., monthly
CT scans for a condition usually requiring only a single
scan); and
• Items and services customarily provided by the research
sponsors free of charge for any enrollee in the trial.”
Source: CMS. NCD for Routine Costs in Clinical Trials (310.1).
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7/11/2014
Patient Protection and
Affordable Care Act (PPACA)
ACA and Clinical Trials
• The provision prohibits health
Clinical Trials Provision (H.R. 3590,
Sec. 2709)
plans or insurance issuers from:
– Denying participation in clinical
trials;
– Denying or limiting coverage of
routine patient costs, subject to the
plan's out-of-network coverage
policy; and/or
– Discriminating against the individual
on the basis of participation in a trial.
 Signed into law in 2010
 In effect 1/1/2014
13
PPACA:
Clinical Trials Coverage
14
ACA: Approved clinical trial
• The term “approved clinical trial” is defined in
the statute as a:
• Phase I, phase II, phase III, or phase IV
clinical trial that is conducted in relation to the
prevention, detection, or treatment of cancer
or other life-threatening disease or condition
and is one of the following:
• Coverage required for routine
costs of clinical trials
• Does not require insurer to cover
experimental product or data
collection required solely for the
trial
• Does not preempt state law if
more protective
– 1. A federally funded or approved trial.
– 2. A clinical trial conducted under an FDA investigational
new drug application.
– 3. A drug trial that is exempt from the requirement of an
FDA investigational new drug application.
15
PPACA is Not a Panacea for
Clinical Trials Coverage
16
PPACA is Not a Panacea for
Clinical Trials Coverage
• The PPACA legislation does not include the
following (however, does not mandate nonpayment):
• “Grandfathered plans”
– Clinical Trial coverage provisions
will not affect employer-based
insurance health plans currently in
effect as of March 23, 2010.
– Items and services required for the provision of the
investigational item (e.g., administration of the noncovered chemotherapy drug);
– Items and services required for the clinically
appropriate monitoring of the effects of the item or
service, or the prevention of complications;
– Items and services that are medically necessary for
the diagnosis and treatment of complications arising
from the provision of an investigational item or
service.
17
18
3
7/11/2014
Patient Protection and Affordable Care Act
and Grandfathering (Not just the huge multistate companies):
Revised University of Michigan
Clinical Trial Benefit Language
•
The University of Michigan believes the
University of Michigan Group Health Plan is a
“grandfathered health plan” under the Patient
Protection and Affordable Care Act (the
Affordable Care Act). As permitted by the
Affordable Care Act, a grandfathered health plan
can preserve certain basic health coverage that
was already in effect when that law was
enacted. Being a grandfathered health plan
means that your plan may not include certain
consumer protections of the Affordable Care Act
that apply to other plans…
We cover the routine costs of items and Services related to
Phase I, Phase II, Phase III and Phase IV Clinical Trials
whose purpose is to prevent, detect or treat cancer or other
life-threatening disease or condition. Experimental treatment
and services related to the Experimental treatment are
covered when all of the following are met:
–
–
–
–
BCN considers the Experimental treatment to be conventional treatment when used to
treat another condition (i.e., a condition other than what you are currently being treated
for).
The treatment is covered under your Benefit Document and attached Amendments
when it is provided as conventional treatment.
The Services related to the Experimental treatment are covered under this Benefit
Document and attached Amendments when they are related to conventional treatment.
The Experimental treatment and related Services are provided during BCN-approved
clinical trial (check with your provider to determine whether a Clinical Trial is approved
by BCN).
Note: This Benefit Document does not limit or preclude the use of
antineoplastic or off-label drugs when Michigan law requires that
these drugs, and the reasonable cost of their administration, be
covered.
19
Clinical Trials and Medicare
Advantage (MA) Programs
Letter to CMS from professional
health-care organizations
• Any outpatient services (routine costs) related to a qualified clinical trial for a Medicare Advantage member should be billed to Traditional Medicare.
• Medicare will reimburse qualifying clinical trial claims on behalf of MA members and will waive the Part A and Part B deductibles. MA plans are responsible for the remaining original Medicare coinsurance minus the plan’s normal member copays for the incurred types of service. • Providers need to submit the bills to the appropriate MAC using the proper modifiers and ICD‐9 (10) codes.
• Investigational Device Exemptions (IDE Cat A and B) claims should be submitted to MA plans.
• Qualified Clinical Trials should be submitted Fee‐for‐Service to the MAC.
• CED have special coverage/payment policies.
• NCCN, ASCO, and 20 other organizations representing
people impacted by serious or life-threatening
diseases, specialty providers, and research
professionals are urging the Centers for Medicare &
Medicaid Services (CMS) to correct a long-standing
inequity in Medicare coverage by requiring that
Medicare Advantage plans provide coverage for clinical
trials.
• CMS policy currently requires individuals in Medicare
Advantage plans to relinquish their Medicare
Advantage coverage and revert to standard fee-forservice Medicare if they wish to participate in a clinical
trial. The policy is confusing and may deter Medicare
Advantage enrollees from participating in a clinical trial.
21
20
22
When I’m talking to insurers:
What does it mean to
“Cover clinical trials”?
Do you cover…
What is the Medicare as
Secondary Payer (MSP) rule?
• Standard care associated with the disease diagnosis
and treatment (i.e. scans, laboratory testing, physician
visits, anti-emetics, blood product transfusions,
standard of care therapeutics)?
Private
Insurance
• Administration costs of the investigational treatment?
1. Clinical
Trial
• Monitoring for complications of the patient during
and after the investigational treatment?
• Complications that may arise from the investigational
treatment?
2.
Unanticipated
Serious
Subject
Injury
3. Who
Pays
???
Sponsor
Medicare
What is your role in advice and
administration to self-funded plans?
23
24
4
8/14/2014
CMS MSP Position
Contract Language with
MSP Issues
• CMS’s current position is that if a
private sponsor of a clinical trial
agrees to cover any costs of
subject injuries that were denied
by third party payers then the
sponsor has made a commitment
to be the primary payer. MSP laws
are clear that Medicare is always
the secondary payer. Medicaid
laws confirm that Medicaid is
always the payer of last resort.
25
MSP and Routine Care
• ". . .Wonder Biotech will pay
reasonable and appropriate
medical and hospital expenses for
the treatment of adverse events,
where the claim is denied by the
study subject's insurance, which
occur to Study subjects as direct
result of the proper administration
of Study drug, or proper
performance of research
procedures specifically required by
the Protocol . . . ."
26
Subject Injuries in a Trial:
Section 111 of the MMSEA
• CMS has extended their MSP guidance
beyond the costs of research related
injuries to the topic of routine care.
CMS states that if the research sponsor
agrees to pay routine care costs when
there is no expectation of payment
from any other source and without
regard to the beneficiary’s ability to
pay, then Medicare cannot pay and the
beneficiary cannot be charged for the
services. CMS views this scenario as
one where there is no legal obligation
for the patient to pay and therefore
Medicare cannot reimburse for the
services.
• The liability carrier, including a
clinical sponsor who is liable for
injuries, is required to report one
time payments and ongoing
liability for Medicare beneficiaries.
27
28
Language from An Insurance Plan
from a Self-Funded Company
• The term “Experimental” when used in
reference to a drug, device, treatment
and/or procedure…satisfies..the following:
a drug, device, treatment or procedure
which Reliable Evidence shows is the
subject of an on-going Phase I, II, or III
clinical trial or is under study to determine
its maximum tolerated dose, its toxicity, its
safety, or its efficacy as compared with a
standard means of treatment or
diagnosis…
29
30
5
Clinical Trials Resources Clinical Trials Coverage
An ASH-supported provision included in the health reform law requires health insurance plans to
provide coverage for routine costs associated with participation in federally-funded clinical trials
beginning in January 2014. Under the terms of the law, insurers will be prohibited from dropping
coverage because an individual chooses to participate in an approved clinical trial and from denying
coverage for routine care that they would otherwise provide just because an individual is enrolled in
a clinical trial. (Routine costs include any drugs, procedures, and/or services a patient needs while
participating in the trial that the insurer would normally cover, even if the patient were not
participating in the trial. Insurers are not required to cover anything outside of the routine costs
(often called research costs), which includes the treatment or procedure being studied, any
procedure done only to collect data for the study, and anything that is not related to the standard
treatment for your condition. Research costs, however, are often covered by the trial’s sponsor.)
The requirement applies to all insurance products (with the exception of certain “grandfathered”
health plans in existence prior to enactment of the health reform law), including those offered in the
Federal Employees Health Benefits Program, and to all clinical trials that treat cancer or other lifethreatening diseases. Depending on the plan, an insurance provider may require a patient to visit a
doctor or hospital who participates in the health plan’s network (an “in-network provider”).
However, if a plan includes coverage for out-of-network services, the insurer must cover routine
costs of care for an out-of-network clinical trial.
While the statute does set minimum standards for coverage, some factors may vary depending on
the trial, as well as existing state regulations. States that have enacted laws and policies that go above
and beyond the federal standard laid out in the provision would not be preempted.
In late April 2013, the Departments of Health and Human Services and Labor (which are both
responsible for implementing the various provisions of the health reform law) announced there
would not be federal regulations to implement the clinical trials coverage provision of the health
reform law. The agencies determined the statutory language was self-implementing, and indicated
that the Departments do not expect to issue regulations in the near future. Rather, the Departments
determined that, “group health plans and health insurance issuers are expected to implement the
requirements . . . using a good faith, reasonable interpretation of the law.”
In June 2013, ASH joined more than 50 organizations in sending a letter to the Secretaries of Health
and Human Services and Labor urging the agencies to issue regulations or guidance implementing
the clinical trials provision. The letter expresses concern that, absent federal regulations,
“implementation of this provision will be very uneven across the country and many consumers may
be denied a new protection they should be guaranteed under the law.” The letter urges the
Departments to either issue regulations or guidance prior to the January 1, 2014 effective date of the
provision or “conduct immediate outreach to states operating exchanges to ensure that clinical trials
coverage is included and establish a clear and effective mechanism for consumers to report concerns
relating to the coverage of clinical trials.”
The Departments have indicated they “will work together with employers, plans, issuers, states,
providers, and other stakeholders to help them come into compliance with the law and will work
with families and individuals to help them understand the coverage for clinical trials provision and
benefit from it as intended.”
ASH will also continue to work with physician organizations and patient groups to ensure adequate
coverage for those enrolled in clinical trials. The Society encourages any member with a specific
concern about clinical trials coverage to contact ASH Legislative Advocacy Manager Tracy Roades
at troades@hematology.org so that ASH can work with the relevant federal agencies to determine if an
insurer is not in compliance with the clinical trials coverage provision of the health reform law.
Affordable Care Act Provision Requiring Insurance Coverage of Clinical Trials
The Patient Protection and Affordable Care Act (ACA) added Section 2709 to the Public Health Service
Act, which is the first federal law requiring that private insurers cover routine patient costs for
individuals participating in clinical trials for the prevention, detection, and treatment of cancer or other
life-threatening diseases or conditions.
Historically, some health plans have denied coverage for drugs or services associated with clinical trials.
In addition, plans have also denied coverage of routine patient costs that are offered as part of the clinical
trial. This new provision requiring insurance coverage of these routine costs may enable patients
previously denied coverage for participation in a clinical trial, the opportunity to afford clinical trial
participation. It is important to understand the law and how it can be used it to enable clinical trial
participation, whether that involves assisting patients in finding an “approved” clinical trial, advocating
for their participation in the trial, or helping them through the appeals process if their plan denies
coverage.
The provision prohibits health plans or insurance issuers from:
• Denying participation in clinical trials;
• Denying or limiting coverage of routine patient costs, subject to the plan's out-of-network
coverage policy; and/or
• Discriminating against the individual on the basis of participation in a trial.
What is the purpose of this document?
ASCO has created this information to educate physicians, cancer researchers, health professionals,
financial counselors, patients, and other stakeholders on Section 2709. ASCO has been a long-time
proponent of insurance coverage of clinical trials and has been working to facilitate implementation of
the new law, including education and outreach efforts.
Although the coverage requirement is now in statute, the federal government has not yet issued
regulations to guide implementation. Instead, the Departments (includes Departments of Labor, Health
and Human Services, and the Treasury) posted a message on their websites stating the law is “selfimplementing” and “group health plans and health insurance issuers are expected to implement the
requirements of PHS Act section 2709 using a good faith, reasonable interpretation of the law.” While
much of the statutory language is clear, there is no assurance that all parties will agree on the legal
interpretation of each element of the provision.
ASCO encourages all individuals and parties involved in clinical trials to consult the plan and insurer for
further and more detailed guidance on the available coverage associated with a particular trial. While the
statute does set minimum standards for coverage, some factors may vary depending on the trial, as well as
existing state regulations. Clinical sites are also encouraged to consult with the clinical trial sponsor
concerning some of the requirements.
The information in this guide is not intended as medical or legal advice, or as a substitute for
consultation with insurers, plans, or trial sponsors. The mention of any product, service, or
treatment should not be constructed as an ASCO endorsement.
© 2014 American Society of Clinical Oncology. All rights reserved.
1
Basic Questions Regarding the ACA Clinical Trials Coverage Provision
 What does the law require?
 What types of clinical trials are included in this provision?
o Federally funded or approved trials
o Investigational New Drug (IND) application
 Which types of health plans/insurers are required to comply?
o Self-insured employers’ health benefit plans
 What plans are not covered by this provision?
o Grandfathered plans
 What does a potential trial participant have to do to qualify for coverage?
 What services/items must the insurer/health plan pay for?
o Routine costs vs. research or investigational costs
 Can potential trial participants go out-of-network to access a clinical trial?
 Can patients seek coverage for a clinical trial at a site that is outside their state?
 When does the requirement become effective?
 How does the new federal law apply in states with laws that already require health plans to
cover clinical trials?
 What does it mean for patients?
 Is there an appeals process patients can use?
 Where can I find additional information?
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© 2014 American Society of Clinical Oncology. All rights reserved.
2
What does the law require?
The ACA provision prohibits insurers from denying or limiting coverage for routine clinical care for
individuals enrolled on a clinical trial that would otherwise be provided if the individual was not a study
participant. (For more information about routine costs, see also What services/items must the health plan
pay for?). Insurers may not prevent a qualified individual from participating in an approved clinical trial,
and may not drop or limit coverage if an individual chooses to participate in a trial.
The law provides the following information:
If a group health plan or a health insurance issuer offering group or individual health insurance
coverage provides coverage to a qualified individual, then such plan or issuer:
1. May not deny the individual participation in the clinical trial;
2. May not deny (or limit or impose additional conditions on) the coverage of routine
patient costs for items and services furnished in connection with participation in the
trial; and
3. May not discriminate against the individual on the basis of the individual’s
participation in such trial.
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© 2014 American Society of Clinical Oncology. All rights reserved.
3
What types of clinical trials are included in this provision?
Section 2709 applies to all approved clinical trials. An approved clinical trial, as defined in the statute, is
a phase I, II, III, or IV clinical trial that relates to the prevention, detection or treatment of cancer or
other life-threatening diseases that also satisfies one of three requirements:
1. The trial is federally funded;
2. The trial is conducted under an investigational new drug application; or
3. The trial is exempt from such an investigational new drug application.
------------------------------------------------------------------------------------------------------------------------------Which federally funded trials qualify as “approved trials”?
Many trials will qualify as approved clinical trials because they have an IND or are IND exempt.
Alternatively, some clinical trials will qualify because they are funded or approved by the federal
government. The statute states that clinical trials “funded or approved” by one of the following entities
are covered:
1.
2.
3.
4.
5.
The National Institutes of Health (NIH) – which includes the National Cancer Institute (NCI)
The Centers for Disease Control and Prevention (CDC);
The Agency for Healthcare Research and Quality (AHRQ);
The Centers for Medicare & Medicaid Services (CMS);
A cooperative group or a center of any of the following: NIH, CDC, AHRQ, CMS, Department
of Defense (DOD) or Department of Veterans Affairs (VA);
6. A qualified non-governmental research entity identified in the guidelines issued by NIH for
center support grants;
7. Clinical trials performed by the VA, DOD or Department of Energy (DOE) are covered if certain
additional criteria are met.
In-kind contributions
The law indicates that funding can include monetary contributions or “in kind contributions.”
Although the term “in kind contributions” is not further defined in the statute, this phrase
typically refers to non-monetary support in the form of items or services. The law does not
specify a minimum dollar amount or value that must come from federal sources to qualify.
Approved vs. funded
In addition, the legislation suggests that a study “approved” by one of the listed federal entities is
considered to be “federally funded” even if no money or in kind contributions are provided by the
federal entity. Although a definition is not provided for what it means for a trial to be “approved”
by most of the listed federal agencies, it could mean that a federal agency has reviewed the trial in
some manner.
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© 2014 American Society of Clinical Oncology. All rights reserved.
4
Cooperative groups or centers
The statute also specifies that trials are covered if they are conducted by cooperative groups or
centers of the NIH (including NCI), CDC, AHRQ, and CMS. The NCI designates cancer centers
and Cooperative Group research networks (including the Children’s Oncology Group, the
Alliance for Clinical Trials in Oncology, NRG Oncology, ECOG-ACRIN Cancer Research
Group, and SWOG), and is in the process of establishing the National Clinical Trials Network.
The NCI also funds the Specialized Programs of Research Excellence (SPORES).
In the case of clinical trials performed directly by VA, DOD or DOE, approval and review of the
study by the Department is mandatory and the law provides greater specificity regarding what
process must exist for approval and review of the study.
What about cancer control trials?
The statute covers trials being done for “the prevention, detection, or treatment of cancer.”
Investigational New Drug (IND) Application
The Food and Drug Administration (FDA) requires drugs under investigation in a clinical trial that are not
already approved by the FDA obtain an investigational new drug (IND) application. The IND number
typically is noted on the trial protocol, and the trial sponsor can provide detailed information about the
IND status of the drug involved in the trial.
Exempt from having an Investigational New Drug Application
Detailed information about the IND status of the drug or device involved in the trial can be obtained from
the sponsor of the clinical trial. The Code of Federal Regulations (21 C.F.R. § 312.2(b)) defines the
clinical investigation of a lawfully marketed drug as exempt from the requirements of an IND application
if all the following apply:
1. The investigation is not intended to be reported to FDA as a well-controlled study in support
of a new indication for use, nor intended to be used to support any other significant change in
the labeling for the drug;
2. If the drug that is undergoing investigation is lawfully marketed as a prescription drug
product, the Investigation is not intended to support a significant change in the advertising for
the product;
3. The investigation does not involve a route of administration or dosage level or use in a patient
population or other factor that significantly increases the risks (or decreases the acceptability
of the risks) associated with the use of the drug product;
4. The investigation is conducted in compliance with the requirements for institutional review
set forth in part 56 and with the requirements for informed consent set forth in part 50; and
5. The investigation is conducted in compliance with the requirements of §312.7 (relating to the
promotion of investigational drugs).
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© 2014 American Society of Clinical Oncology. All rights reserved.
5
Which types of health plans/insurers are required to comply?
This statute applies to most third-party payers of health benefit or insurance claims, including group
health plans, self-insured employers’ health benefit plans (where the employer, not insurance company,
bears the risk of offering health coverage), health insurance issuers, and the Federal Employees Health
Benefits Program. Plans sold on the health insurance exchanges (individual and small business plans) and
employer sponsored plans are also required to comply with this provision.
------------------------------------------------------------------------------------------------------------------------------Self-insured employers’ health benefit plan
Large employers are allowed to offer health plans that are exclusively regulated under the federal
Employee Retirement Income Security Act (ERISA), rather than state law. If an employer remains at risk
for the health insurance provided to its employees, this self-insured form of ERISA plan is not subject to
state insurance laws whether the employer administers the plan directly or the employer hires a separate
insurance company to administer the plan. Prior to enactment of the ACA, self-insured ERISA plans were
not required to cover the routine costs from clinical trials, even in instances where state laws regarding
clinical trials coverage existed. However, the ACA coverage requirement for the routine costs of clinical
trials now applies to all ERISA plans, unless they have grandfathered status.
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© 2014 American Society of Clinical Oncology. All rights reserved.
6
What plans are not covered by this provision?
Grandfathered plans | A “grandfathered” plan is defined as a group health plan (which includes single
employer plans and multiemployer plans, whether insured or self-funded) or health insurance coverage
that was in existence on March 23, 2010 (the date of enactment of the ACA). Grandfathered plans are
only subject to certain provisions of the ACA, and are exempt from the clinical trials coverage provision.
See section: How do I know if a plan is grandfathered? Plans lose their grandfathered status by making
changes to their benefits and coverage that are defined in regulations. Once a plan loses its
grandfathered status it must comply with all ACA provisions, including section 2709.
Medicaid plans | Unfortunately, the ACA clinical trials coverage provision does not apply to Medicaid
plans. Federal law does not require that states provide coverage of clinical trials through Medicaid plans
(fee-for-service or Medicaid managed care). ASCO would support legislation would require coverage of
clinical trials under Medicaid.
Medicare plans | As a result of previous coverage policy (effective September 19, 2000), Medicare
already covers the routine care costs associated with clinical trial participation on most types of clinical
trials and will not be impacted by this provision.
------------------------------------------------------------------------------------------------------------------------------How do I know if a plan is grandfathered?
A grandfathered plan must provide notice to enrollees of its grandfathered status in all informational
materials that describe plan benefits. For more information about these plans, contact the U.S. Department
of Labor’s Employee Benefits Security Administration:
www.askebsa.dol.gov
866-444-3272
How do grandfathered plans lose their grandfathered status?
If a grandfathered plan either cuts benefits or increases costs for plan members, it will lose its
grandfathered status and all of the ACA provisions will apply –including the clinical trials coverage
requirement. Some examples of changes that may result in a plan’s loss of grandfathered status include
elimination of benefits to diagnose or treat a particular condition, increased co-insurance percentages,
fixed-amount cost-sharing other than a copayment, or fixed-amount copayments, changes in annual limits
and/or changes in the plan’s contribution rates.
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© 2014 American Society of Clinical Oncology. All rights reserved.
7
What does a potential trial participant have to do to qualify for coverage?
The statute requires that the individual receiving clinical trials services be a qualified individual. A
qualified individual is an individual who meets the participation eligibility requirements of the trial’s
protocol. Eligibility can be determined by (1) a referring health care professional, or (2) medical and
scientific information provided by the participant. The statute states:
The term ‘qualified individual’ means an individual who is a participant or beneficiary in a health
plan or with coverage who meets the following conditions:
1. The individual is eligible to participate in an approved clinical trial according to the
trial protocol with respect to treatment of cancer or other life-threatening disease or
condition.
2. Either –
(A) the referring health care professional is a participating health care provider
concludes that the individual’s participation in such trial would be appropriate based
upon the individual meeting the conditions described in paragraph (1); or
(B) the participant or beneficiary provides medical and scientific information
establishing that the individual’s participation in such trial would be appropriate based
upon the individual meeting the conditions described in paragraph (1).
------------------------------------------------------------------------------------------------------------------------------Referring Health Care Professional and “Participating Health Care Provider”
One pathway for a trial participant to demonstrate that they are eligible for a trial is to have a referring
health care professional conclude that their participation in the trial “would be appropriate” according to
the trial protocol. The reference to a “participating health care provider” in this part of the law appears to
refer to a health care professional who both refers the patient to the trial and is able to enroll the patient on
the trial.
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© 2014 American Society of Clinical Oncology. All rights reserved.
8
What services/items must the insurer/health plan pay for?
The insurer or health plan must provide coverage of routine patient costs. The definition of these costs
included in the statute is written broadly. To simplify, routine costs include all items and services that the
payer would cover for a patient not enrolled in a clinical trial.
Items and services are not routine costs if they are investigational—solely for data collection and
analysis purposes and not for direct clinical management of the patient—or for a service inconsistent
with the established standards of care for the patient’s diagnosis. These investigational costs,
sometimes referred to as “research costs,” may be covered by the trial sponsor, so it is advised to contact
all involved parties including the payer or plan issuer and for clinical sites, the trial sponsor to discuss
coverage.
------------------------------------------------------------------------------------------------------------------------------Service that is “Clearly Inconsistent with Standard of Care”
The provision states that routine patient costs do not include a service that is “clearly inconsistent with
widely accepted and established standards of care for a particular diagnosis.” An insurer may attempt to
deny coverage on the grounds that the service or item is “clearly inconsistent with the established
standard of care.” Providers may consider requesting that the insurers prove that the item or service is
inconsistent with the standard of care. Providers, patients, and representatives from the clinical trial
should work together and with financial counselors and billing specialists to ensure understanding of the
trial and coverage.
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© 2014 American Society of Clinical Oncology. All rights reserved.
9
Can potential trial participants go out-of-network to access a clinical trial?
The ACA does not guarantee individuals access to health care providers who are not participating in a
health plan or insurer’s network. Payers are only required to cover routine patient costs of items and
services delivered by out-of-network providers if out-of-network benefits are part of the patient’s
coverage or plan.
-------------------------------------------------------------------------------------------------------------------------------
Can patients seek coverage for a clinical trial at a site that is outside their state?
The ACA coverage requirement also applies if a patient has to leave their state of residence to participate
in a clinical trial. This provision was included because some states’ laws do not provide coverage for
clinical trials operated outside the state. If the out-of-state investigator is not within the health plan’s
network, the plan may deny coverage for services provided by that investigator, unless the patient has
coverage for out-of-network providers.
-------------------------------------------------------------------------------------------------------------------------------
When does the requirement become effective?
The requirement is effective for all plans newly issued or renewed on or after January 1, 2014.
-------------------------------------------------------------------------------------------------------------------------------
How does the new federal law apply in states with laws that already require health
plans to cover clinical trials?
The federal law is now the minimum national standard for insurance coverage of clinical trials. If a state
has a law that is more comprehensive, its coverage requirements apply in addition to the federal law –but
only for state-regulated insurance plans, which does not include ERISA plans. For example, a state law
may require coverage of clinical trials for any disease or may require Medicaid to cover clinical trials.
ASCO’s main page on clinical trials coverage (www.ASCO.org/ClinicalTrialsCoverage) contains
helpful information and links to other resources on this topic.
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© 2014 American Society of Clinical Oncology. All rights reserved.
10
What does it mean for patients?
Historically, some health plans have denied coverage for drugs or services associated with clinical trials.
In addition, plans have also denied coverage of routine patient costs that are offered as part of the clinical
trial. This new provision requiring insurance coverage of these routine costs may enable patients
previously denied coverage for participation in a clinical trial, the opportunity to afford clinical trial
participation. It is important to understand the law and how it can be used it to enable clinical trial
participation, whether that involves assisting patients in finding an “approved” clinical trial, advocating
for their participation in the trial, or helping them through the appeals process if their plan denies
coverage.
While ASCO believes that the ACA provision is very straightforward, it is likely that securing
compliance with the law may require considerable negotiations with some insurers or health plans. ASCO
has developed an attestation form that can be used as a tool to demonstrate that the patient’s
circumstances and the trial under consideration meet the requirements of the law.
-------------------------------------------------------------------------------------------------------------------------------
Is there an appeals process patients can use?
The ACA standardizes the internal and external appeals process for all non-grandfathered group health
plans and health insurance issuers offering individual or group health insurance coverage. Information
about the appeals process is available at www.healthcare.gov/how-do-i-appeal-a-health-insurancecompanys-decision.
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© 2014 American Society of Clinical Oncology. All rights reserved.
11
Where can I find additional information?
The following organizations can provide further information about clinical trials coverage. This list is by
no means exhaustive, especially considering the continually changing nature of programs and services.
State insurance department | Most states have their own departments or agencies that facilitate
insurance coverage. The Medicare website provides links to state health insurance departments.
Information on plans bought through Health Insurance Exchanges/Marketplaces | The ACA
establishes state-specific Health Insurance Marketplaces, also referred to as “Exchanges.” Any plan
purchased through the Marketplace is considered an “exchange” plan and must comply with the clinical
trials coverage provision. You can access information about your specific state at
https://www.healthcare.gov/what-is-the-health-insurance-marketplace/.
 State-Based Marketplaces/Exchanges – Some states have set up their own exchanges.
If you live in a state that operates its own Marketplace, you can contact that agency for
more information.
 Federal-Based Marketplaces/Exchanges – If your state does not currently operate its
own Marketplace, Healthcare.gov is your resource for further information.
For Employer-Sponsored Plans | The Employee Benefits Security Administration, U.S. Department
of Labor can answer inquiries at www.askebsa.dol.gov or 866-444-3272.
Patient Organizations | There are various patient organizations that specialize in supporting and
advocating for patients and their access to quality care, including participation in clinical trials.
 Patient Advocate Foundation (www.patientadvocate.org)
 CancerCare (www.cancercare.org)
 Cancer Support Community (www.cancersupportcommunity.org)
ASCO | ASCO does not have the resources to intervene in specific patient cases, but has general
information including an article on www.cancer.net/clinicaltrials that providers can offer patients
on this law. ASCO has also developed a patient information fact sheet at www.cancer.net/factsheets
which contains helpful information on this clinical trials coverage provision and has been reviewed
by a central IRB. The Cancer.Net site also offers general information about clinical trials including
participation, phases of trials, informed consent, and how to find a trial.
ASCO is monitoring implementation of the ACA provision and solicits information on any challenges
you encounter with the law. Please contact ResearchPolicy@asco.org with any comments or questions.
previous  back to basic questions  statutory language
© 2014 American Society of Clinical Oncology. All rights reserved.
12
ASCO ANSWER S
CLINICAL TRIALS COVERAGE THROUGH
THE AFFORDABLE CARE ACT
WHAT IS THE AFFORDABLE CARE ACT?
The Patient Protection and Affordable Care Act (ACA),
signed into law March 2010, changed several rules about
health care insurance coverage in the United States,
including coverage of clinical trials. Clinical trials study
new ways to treat, prevent, or diagnose cancer, manage
side effects, or improve patients’ quality of life. They
often offer treatment options that would not otherwise be
available outside of the clinical trial.
HOW ARE CLINICAL TRIALS COVERED
THROUGH THE ACA?
The ACA sets the national minimum for coverage of
clinical trials. Health plans newly issued or renewed on
or after January 1, 2014, will not be allowed to limit or
deny your coverage if you choose to participate in an
approved clinical trial. This requirement applies to group
Find additional cancer information at www.cancer.net.
health plans offered by your employer and plans purchased
from an insurance company through an ACA insurance
exchange. If your state has a law requiring more coverage, your insurer will continue to follow those requirements in
addition to the ACA requirements.
WHICH HEALTH PLANS DO NOT FOLLOW THE ACA REQUIREMENTS
FOR CLINICAL TRIALS COVERAGE?
The ACA clinical trial coverage provision does not apply to a “grandfathered” plan, which is a health plan that existed
when the ACA was signed into law. Some grandfathered plans may already cover clinical trials. If your grandfathered
insurance plan has reduced benefits or increased costs since March 23, 2010, or does so in the future, it is no longer a
grandfathered plan. Then, it will need to follow all ACA requirements, including the clinical trials coverage requirement.
A grandfathered plan must notify you of its grandfathered status in all informational materials that describe your plan
benefits.
WHAT COSTS DOES THE ACA REQUIRE MY HEALTH INSURANCE TO COVER?
Your insurer must provide coverage for routine costs of care. Routine costs of care include any treatments, procedures,
and services you need while participating in the clinical trial that would normally be covered if you were not participating
in a trial. The ACA does not require your insurer to cover the research costs for the clinical trial. These may include the
drug being studied and any treatments, tests, or procedures done to collect data for the study. These research costs are not
usually considered part of the standard care for your condition, but they are often covered by the clinical trial sponsor.
ASCO Answers is a collection of oncologist-approved patient education materials developed by the American Society of
Clinical Oncology (ASCO) for people with cancer and their caregivers.
MADE AVAILABLE THROUGH
QUESTIONS TO ASK A CLINICAL TRIAL’S RESEARCH TEAM
TERMS TO KNOW
Before participating in a clinical trial, consider asking the research team the
following questions about clinical trial costs:
Approved clinical trial:
A study that is done to help
prevent, detect, or treat cancer or
another life-threatening disease
and is federally funded, conducted
under an IND, or exempt from
having an IND application
zzWho
is sponsoring or funding this clinical trial?
zzWhat
costs are associated with this clinical trial?
zzWhich
zzCan
of these costs are covered by the clinical trial sponsor?
you help me find out what costs will be covered by my insurance?
zzWhich
costs will I be responsible for?
Find additional questions related to clinical trials at www.cancer.net/clinicaltrials and
questions on the cost of care and the ACA at www.cancer.net/managingthecostofcare.
WHERE TO FIND ADDITIONAL INFORMATION
Several governmental organizations can help you understand required health care
coverage:
zzCenter
for Consumer Information and Insurance Oversight (www.healthcare.gov)
zzState
Insurance Departments (www.medicare.gov/Contacts/staticpages/sids.aspx)
zzU.S.
Department of Labor (www.askebsa.dol.gov)
Other organizations to help you understand how these health insurance requirements
affect your care:
zzPatient
Advocate Foundation (www.patientadvocate.org)
zzCancerCare:
zzCancer
(www.cancercare.org)
Support Community (www.cancersupportcommunity.org)
For more information, visit ASCO’s
patient website, www.cancer.net, or
call 888-651-3038.
The ideas and opinions expressed here do not necessarily reflect the opinions of the American Society of Clinical
Oncology (ASCO) or The Conquer Cancer Foundation. The information in this fact sheet is not intended as medical or
legal advice, or as a substitute for consultation with a physician or other licensed health care provider. Patients with
health care-related questions should call or see their physician or other health care provider promptly and should not
disregard professional medical advice, or delay seeking it, because of information encountered here. The mention of
any product, service, or treatment in this fact sheet should not be construed as an ASCO endorsement. ASCO is not
responsible for any injury or damage to persons or property arising out of or related to any use of ASCO’s patient
education materials, or to any errors or omissions.
Health Care Reform:
A common term for the Affordable
Care Act
Investigational New
Drug (IND) application:
Researchers must submit an IND
application to the U.S. Food and
Drug Administration (FDA) to
get approval to sell new drugs or
treatments
Health Insurance
Exchange/Marketplace:
HealthCare.gov is where a person
can purchase a state-specific health
plan that must follow the ACA
requirements. These plans are
referred to as “exchanges.” Some
states operate their own exchanges,
and if you live in one of these
states, you can contact your state
agency for more information
Research costs:
The treatment or procedure being
studied or any tests or procedures
needed to collect data for the
clinical trial; these costs are often
paid for by the trial sponsor
Routine costs:
Any item or service for your care
that would normally be covered if
a patient is not in a clinical trial
Sponsor:
The company or organization that
funds a clinical trial
A central IRB has determined that this information is not research and can be distributed to patients
considering participation or already participating in a clinical trial.
2318 Mill Road, Suite 800, Alexandria, VA 22314  Toll Free: 888-651-3038  Phone: 571-483-1300
www.asco.org  www.cancer.net  www.jco.org  www.jopasco.org  www.conquercancerfoundation.org
©2014 American Society of Clinical Oncology. For permissions information, contact permissions@asco.org.
Transition to ICD‐10 Richard Whitten, MD Dick Whitten remains a practicing general internist with the University of Washington at Harborview Medical Center after a prior eighteen years in critical care. He was Medical Director for 12 years for Washington's Health Care Authority and its Basic Health Plan, becoming Medical Director of Medicare B for Washington, Alaska and Hawaii in 2000 and since 2008 Medical Director for DME Jurisdiction D. He was on the American Medical Association's Relative Value System (RVS) Update Committee (“RUC”) for 12 years, its Vice Chair as well as Chair of the Health Care Professionals Advisory Committee for six and on the CPT Assistant Editorial Panel from 2007‐2010. Dick graduated from Yale with a degree in economics, worked in Chicago, then went to Harvard Business School receiving an MBA with Distinction. His Internship and Residency were in Internal Medicine, then two years as a Robert Wood Johnson Clinical Scholar, all at the University of Washington, where he remains an Associate Clinical Professor. Medicare ICD-10 (as of 7/2014)
Richard W. Whitten, MD, FACP
Contractor Medical Director - Medicare
dick.whitten@noridian.com
206-979-5007
ASH/ASCO - July 2014
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Disclosure of Financial
Relationships
Richard W. Whitten, MD
Has no relationships with any entity
producing, marketing, re-selling, or
distributing health care goods or
services consumed by, or used on,
patients.
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04/01/2014 Protecting Access
to Medicare Act of 2014
(PAMA) (Pub. L. No. 113-93)
was enacted: “The Secretary
may not adopt ICD-10 prior
to October 1, 2015...”
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So... Let’s assume the date of
10/01/2015 holds...
What’s important to
consider & to do...
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Contractor LCDs and Articles
14
As of 10/01/2015
• These in DRAFT form are already on the
Medicare Coverage Database (“Fu database”)
listed for individual MAC contractors
• Consider review by ASH &/or ASCO
• Comments/recommendations to individual
MACs
• Organize input for upcoming state-by-state
CACs
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• Aggressive approach to appeals & to hearings
• Immediate feedback to MACs pointing out
needed changes (use this input as copy for the
appeals)
• Coordinated specialty society input
• Comparison MAC to MACs to assist making
your case
15
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Interim over coming months
• Watch carefully MAC websites (& probably
CMS releases) re:
• Front-end testing
• End-to-end testing
• Consider push from ASH/ASCO
• Additional testing
• Full spectrum of test site types
• Test reporting & interactive updates
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Thank you. Comments/questions welcome:
Please remember to 1st check
www.noridianmedicare.com & Provider
Call Center: 877-908-8431
Dick Whitten, MD, FACP
(206) 979-5007
dick.whitten@noridian.com
ASH/ASCO - July 2014
July 2014 : Supplemental Items
http://www.cms.gov/Regulations-andGuidance/Legislation/NationalPhysician-Payment-TransparencyProgram/index.html
• CMS Open Payments
• 2 Midnight Rule Issues
• Transitional Care Management
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CMS: Open Payments
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https://itunes.apple.com/us/app/open-paymentsmobile-for-physicians/id667567467?mt=8
Observation vs. Admit
• “2-Midnight Rule”: count time from the initial
outpatient clinical service
• If admission decision made after patient has
passed midnight as outpatient and MD expects
patient to require additional midnight, OK
• Unexpected transfer or death exceptions
• Treating MD must “certify” admission is
appropriate
• Treating MD must write admission order
• Verbal order must be signed
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Observation vs. Admit2
Observation vs. Admit3
“…the physician should generally order an
inpatient admission when he or she has
determined either that the beneficiary
requires care at the hospital that is
expected to transcend at least 2 midnights
or that it will involve a procedure
designated by the OPPS as an inpatientonly procedure.”
• “…difficult to make a reasonable prediction, the
physician should not admit the beneficiary…”
• “regulation is framed upon a reasonable and
supportable expectation [of a 2-midnight stay],
not the actual length of care”
• “We do not believe beneficiaries treated in an
intensive care unit should be an exception to this
standard, as our 2-midnight benchmark policy is
not contingent on the level of care required.”
• Exception: New-onset mechanical ventilation
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Medical Review
Unaffected by 2-Midnight Rule
Observation vs. Admit4
• “2 midnight presumption”
• Focus: “LOS crossing only 1 midnight” or less
• Monitor longer stays
• Admission must be medically necessary
• Documentation
• No social/convenience admits
• Billing time: starts after order and patient begins
receiving inpatient services
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29
• Reviews to ensure that the services provided were medically
necessary
• Reviews to ensure that the stay at the hospital was medically
necessary
• Reviews to validate provider coding and documentation as
reflective of the medical evidence
• CERT Reviews under the Improper Payments Elimination
and Recovery Improvement Act of 2012 (Pub. L. 112-248)
• Reviews directed by CMS or other authoritative
governmental entity (including, but not limited to, the HHS
Office of Inspector General and Government Accountability
Office)
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Transitional Care Management
CMS Requirements
The “physician” (MD/DO or qualified NP, PA,
CNS, or CNM) is to “oversee management and
coordination of services, as needed, for all medical
conditions, psychosocial needs and activity of daily
living supports…” for the full 30 days post
discharge (MPFS Final Rule, CY 2013, p. 313)
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• Communication (direct contact, telephone, electronic) with
the patient and/or caregiver within 2 business days postdischarge (or documentation of 2 unsuccessful attempts and
then “continuing efforts until successful”)
• Documented medical and/or psychosocial problems require
medical decision making of high complexity during the
service period.
• Face-to-face visit, within 7 calendar days post-discharge
• Medication reconciliation and management must be
documented no later than the date of the face-to-face visit
33
Transitional Care Management
Services 5
32
Both 99495 & 99496: transition in care is from:
• An inpatient hospital setting
• Observation status in a hospital
• Community Mental Health Center (CMHC) partial
hospitalization, or
• Skilled Nursing Facility (SNF)
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Both 99495 & 99496:
• Payable only once in the 30 days following a
discharge, per patient per discharge, to a
• Single community physician or qualified
nonphysician practitioner (or group practice) who
• Assumes responsibility for the patient’s postdischarge TCM services.
• Bill after the 30 day period – use 30th day as DOS
Home
Nursing Facility (not a Skilled Nursing Facility)
Domiciliary
Rest home, or
Assisted living
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Transitional Care Management
Services 6
• The transition in care is to the patient’s
community setting:
•
•
•
•
•
• Communication (direct contact, telephone, electronic) with
the patient and/or caregiver within 2 business days postdischarge (or documentation of 2 unsuccessful attempts and
then “continuing efforts until successful”)
• Documented medical and/or psychosocial problems require
medical decision making of at least moderate complexity
during the service period.
• Face-to-face visit, within 14 calendar days post-discharge
• Medication reconciliation and management must be
documented no later than the date of the face-to-face visit
Transitional Care Management
Services 4
99496 Transitional Care Management Services
(High Complexity): 3.05 wRVU
approx
$230 & 50 min intraservice
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99495 Transitional Care Management Services
(Moderate Complexity):
2.11 wRVU approx
$160 & 40 min intraservice
35
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Transitional Care Management
Services 7
Transitional Care Management
Services 8
• POS: place where Face-to-Face provided
• Any staff services must meet incident to
requirements
• If readmitted may still be reported, but only once
for the total 30 days, and must follow for all 30
• If patient dies or otherwise transitions from your
care before 30 days, don’t use (do use E&Ms)
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• Do report billable services provided during the
30 days (other than the one E&M that is part of
the service)
• Does not fall under the Primary Care exception
for teaching physicians
• In teaching context, do apply GC modifier and be
sure all criteria met (IOM 100.04 MCPM Ch. 12 § 100.1 – 100.1.6)
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Transitional Care Management
Services 9
Do NOT report: 90951-90970, 98960-98962, 9896698968, 98969, 99071, 99078, 99080, 99090, 99091,
99339, 99340, 99358, 99359, 99363, 99364, 9936699368, 99374-99380, 99441-99443, 99444,
99481X-99483X, 99605-99607 during the time
period covered by the transitional care
management services codes.
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ICD‐10 Resources ICD‐10 Conversion for Hematology 






On October 1, 2015, all healthcare business transactions in the United States must convert from the use of the ninth version of the International Classification of Disease (ICD‐9) to the tenth version (ICD‐10). This is a complete restructuring of the diagnosis codes used by hematologists every day. The transition will take place on a single day so there will not be any time to try the new diagnosis codes. ASH will be helping members to prepare for this transition, primarily by giving examples of the changes in hematology diagnosis coding on its ICD‐10 Conversion for Hematology webpage. Twice a month, a new disease category will be released, comparing the ICD‐10 codes to the ICD‐9. This review should give hematologists real examples so as to understand the effect on their individual practice. If you have any questions about the implementation of ICD‐10 or ASH’s resources, please contact ASH’s Senior Manager for Policy and Practice at bwhitman@hematology.org or 202‐
776‐0544. Conversion Resources ICD‐10 Instructions Overview of ICD‐10 transition and how it will be relevant to hematologists ICD‐10 Myeloid Leukemia Conversion Table ICD‐10 Sickle Cell Disease Conversion Table ICD‐10 Hodgkin Lymphoma Conversion Table ICD‐10 Coagulation Defects Conversion Table ICD‐10 Purpura and other Hemorrhagic Conditions Conversion Table ICD‐10 Lymphoid Leukemia Conversion Table ASCO ICD‐10 Webpage http://www.asco.org/practice‐research/icd‐10 The International Classification of Diseases, 10th Edition, Clinical Modification/Procedure Coding System (ICD‐10 CM/PCS) will fully replace the International Classification of Diseases, 9th Edition, Clinical Modification/Procedure Coding System (ICD‐9) on October 1, 2015. Providers may no longer bill with ICD‐9 codes after this date. Therefore, it is important to take the time to educate oneself about ICD‐10 and determine what impact it will have on your practice. If you have any questions regarding ICD‐10, please contact ASCO via email at billingandcoding@asco.org. ICD‐10 Resources Introduction to ICD‐10 A basic introduction to ICD‐10, this resource provides highlights of what you need to know regarding the transition. Anatomy of an ICD‐10 Code Describes the elements of an ICD‐10 code. Finding an ICD‐10 Code Instructions on how to find the appropriate ICD‐10 code. General Equivalence Mappings (GEMS) A description of GEMS and how they can be used in the transition to ICD‐10. Taking Control of the Transition to ICD‐10 Resources for your practice as you make this transition. Sample Transition Timeline A sample timeline to provide guidance on how to make the transition. Selecting the Appropriate ICD‐10 Training Program (PDF) How to determine the best program for your practice. Medicare and ICD‐10 (PDF) How is the delay affecting CMS' transition to ICD‐10? Coming up…. “Private Payers and ICD‐10” “ICD‐10 and Oncology” “Documentation and ICD‐10” “Rehearsing for ICD‐10” “One month until ICD‐10: Last Minute To‐Do’s” “The month after ICD‐10: What to expect” Payment Reform Panel – What is Really Coming Down the Pike John V. Cox, DO, MBA, FACP, FASCO John V. Cox, DO, MBA, FACP, FASCO is a practicing oncologist with Texas Oncology, P.A. for over 20 years. He completed a fellowship in medical oncology and hematology at the University of Texas Southwestern Medical School and after a stint on the faculty at Southwestern, he entered private practice in Dallas. His interests focus on GI oncology and the delivery of care. He did return to school, and completed an MBA, with a certificate in medical management from University of Texas Dallas in 2008. He is an active leader in his hospital medical staff at Methodist Hospitals of Dallas and his group practice. He is active in the Texas Society of Medical Oncology (past President, current board member), and is the state of Texas oncology representative to the Texas Carrier Advisory Committee of Novatis. He also served as a member of CMS’ Medicare Evidence Development & Coverage Advisory Committee from 2006 to 2010. Dr. Cox is an active volunteer in ASCO and is a liaison member of the Clinical Practice Committee, which he chaired, 2005‐2006. He has served on ASCO’s HIT Workgroup since its formation in 2005, and is a past‐Chair. He has been a liaison of ASCO to the American College of Physicians’ Council of Sub‐
specialty Societies (CSS) and represents ASCO on the CSS workgroup on the patient centered medical home / Neighbor. He is a member of ASCO’s payment reform workgroup, and active in ASCO’s efforts to evaluate / codify new practice models. He is the Education Chair elect for ASCO’s 2015 annual meeting. He has served as a member of the editorial board of the Journal of Clinical Oncology (JCO); and beginning in January of 2009, he became the editor of the Journal of Oncology Practice (JOP).
Dr. Steven L. Allen, MD Dr. Steven L. Allen is the Associate Chief of Hematology of the Don Monti Division of Medical Oncology and Division of Hematology of North Shore University Hospital – Long Island Jewish Medical Center and a Professor of Medicine at the Hofstra North Shore‐LIJ School of Medicine. Dr. Allen's research is focused on the treatment of hematologic malignancies, with special clinical interest in leukemias, lymphomas, multiple myeloma, myelodysplastic syndrome, benign hematologic disorders and coagulation. Dr. Allen is a Fellow of the American College of Physicians and is the author or coauthor of more than 100 original research papers and reviews. He is Chair of the Committee on Practice of the American Society of Hematology, serving on the Task Force on Quality Measures and is co‐chair of the Hematology Work Group of the AMA's Physician Consortium for Performance Improvement, for which he received an Outstanding Service Award from the American Society of Hematology. He is also a member of numerous societies and organizations, including the New York State Society of Medical Oncologists and Hematologists (Secretary) as well as the Committee on Interspecialty of the Medical Society of the State of New York and the Medicare Carrier Advisory Committee as a Hematology and Oncology Representative. Dr. Allen received his medical degree from the Johns Hopkins School of Medicine and completed his Internal Medicine internship and residency and Hematology/ Medical Oncology fellowship at The New York Hospital. ASCO welcomes input on its payment reform proposal, “Consolidated Payments for Oncology Care: Payment Reform to Support Patient‐Centered Care for Cancer.” For a full text copy of the proposal, please visit www.asco.org/paymentreform. CONSOLIDATED PAYMENTS FOR ONCOLOGY CARE:
Payment Reform to Support Patient-Centered Care for Cancer
Summary Overview
The American Society of Clinical Oncology has developed a new method of payment that would enable
medical oncology practices to deliver high-quality, patient-centered care at a more affordable cost,
reduce administrative costs for both practices and payers, and help make community oncology practices,
particularly small and rural practices, financially sustainable so that patients can continue to obtain highquality cancer care in their community. The proposed new payment system, developed by the ASCO
Payment Reform Workgroup, features the following key elements:
Flexible payment better matched to the services oncology practices provide and oncology patients
need. Today, oncology practices are paid only for face-to-face office visits with clinicians and for
administration of parenteral medications; they receive no payment for many other essential services that
patients need and want, such as telephone calls and electronic mail with physicians; education and
counseling services provided by nurses, social workers, and financial counselors; and help in managing
oral medications. Under ASCO’s proposed new payment system, practices would receive five types of
flexible, bundled payments designed to cover currently uncompensated time and costs as well as many
of the services that are currently reimbursed:

New Patient Payment. The oncology practice would receive this payment for each new patient. It
would be much larger than what practices receive today for initial office visits, reflecting the
extensive, uncompensated time oncologists and their staffs spend developing treatment plans and
doing patient education and counseling.

Treatment Month Payment. The oncology practice would receive this payment during each month
the patient is being treated, regardless of whether the drugs used are oral or parenteral. Payments
would be higher to cover the higher costs of treating patients with multiple health problems and/or
poor performance status and for patients receiving more toxic and complex drug regimens. This
payment would replace all current payments for evaluation & management and infusion services,
but reimbursement for drug costs would remain separate.

Active Monitoring Month Payment. The oncology practice would receive this payment during
months when the patient is not being actively treated with medications but is still receiving care and
support from the practice, including testing and monitoring for recurrences or progression of
cancer. Payments would be higher during the initial months after the end of treatment to reflect the
additional help patients need during that transitional phase.

Transition of Treatment Payment. The oncology practice would receive an additional payment
during months when the patient’s disease progressed or recurred or when significant treatment
regimen changes were needed, reflecting the significant additional time needed for treatment
planning and patient education.

Clinical Trial Payment. The oncology practice would receive an additional monthly payment for
each patient participating in a clinical trial. Today, lack of payment to cover the significant time
and costs associated with trials discourages many practices from participating in the research
needed to develop and test new treatments.
In addition to the five bundled payments, the practice would continue to receive separate payments for
tests and major procedures it performs and reimbursement for drugs it purchases for administration
in the office.
Simpler billing structure. Instead of billing 58 separate CPT codes for E&M and infusion services as
is required today, with no payment at all for services such as phone calls or social services, the oncology
practice would only bill a total of 11 service codes that better match the types and costs of services
delivered and cover the full range of services provided —greatly reducing administrative costs for both
oncology practices and payers and simplifying cost-sharing for patients.
More predictable revenues. Other than expenditures on drugs, most of the costs involved in running
an oncology practice are fixed monthly expenses (e.g., staff salaries, rent). The proposed payment
structure would provide more predictable monthly revenues so that an oncology practice can sustain the
services patients need. Moreover, an oncology practice’s revenues would not be as dependent on using
parenterally administered drugs as they are today, thereby reducing the financial penalties practices now
face if patients are treated with oral chemotherapy.
Accountability for delivering high-quality, evidence-based, patient-centered care. In order to
assure patients and payers that the monthly payment system would not cause patients to be undertreated, the amount of payment each oncology practice receives would be decreased by up to 10 percent
if recommended care is not provided, if the quality of care is lower than what other oncology practices
routinely deliver, or if patients experience many preventable complications. Practices that deliver higher
quality care that meets national standards would be rewarded with up to 10 percent higher payments.
Support for coordinated, patient-centered care. The new payment system would complement other
payment reforms that support primary care medical homes and accountable care organizations by giving
medical oncologists the flexible resources they need to deliver the highest-quality oncology care to
patients with cancer at an affordable cost.
ASCO welcomes input on its payment reform proposal,“Consolidated Payments for Oncology Care:
Payment Reform to Support Patient-Centered Care for Cancer.” For a full text copy of the proposal,
please visit www.asco.org/paymentreform.
CONSOLIDATED PAYMENTS FOR ONCOLOGY CARE:
Payment Reform to Support Patient-Centered Care for Cancer
Questions and Answers
1. How Would Patients Benefit from Consolidated Payments for Cancer Care?
Consolidated Payments for Oncology Care (CPOC) would allow oncology practices the
flexibility to provide the full range of services that patients need through a multi-disciplinary
team of professionals. Today, the only services that Medicare and most health plans pay for
are office visits with physicians and infusions of chemotherapy. CPOC would also pay for
phone calls and email contacts with physicians, visits and calls with nurses when patients
experience problems, nutrition counseling, education and support for family and caregivers,
and many other services to help patients and their families deal with the many other
challenges associated with cancer and its treatment. This kind of flexibility will be
particularly helpful to oncology practices and patients in rural areas, where long distances
make it difficult for face-to-face visits between physicians and patients. CPOC would also
pay for the care and support from the patient’s physician if they enter a hospice program.
Separate payments would still be made to oncologists providing consultations and second
opinions, so that both patients and oncologists could be sure that the most effective
treatments are being used, particularly with rare forms of cancer.
CPOC would also simplify patient cost-sharing – rather than basing a patient’s co-insurance
for a visit on which of 58 different types of services were performed and how many of those
services were performed, and rather than forcing patients to pay co-insurance multiple times
per month with different amounts during each visit, patients would pay a single co-insurance
amount each month, with the amount depending primarily on whether they were receiving
treatment and the level of services they needed.
2. How Would Oncology Practices Bill for and Receive CPOC Payments?
Eleven new CPT/HCPCS codes would be created (1 New Patient Payment, 4 levels of
Treatment Month Payment, 3 levels of Active Monitoring Month Payment, 2 levels of
Transition of Treatment Payment, and 1 Clinical Trial Payment). If Medicare or a health
plan agrees to pay for a patient’s care using the Consolidated Payments for Oncology Care
system, the oncology practice would submit a bill for the appropriate codes for that patient in
each month that the practice is caring for the patient.
3. Why is ASCO Recommending Such a Complex New Payment System?
Consolidated Payments for Oncology Care is actually a much simpler payment system than
the way oncology practices are paid now. Today, Medicare and commercial health plans use
Consolidated Payments for Oncology Care
Payment Reform to Support Patient-Centered Care for Cancer
_____________________________________________________________________________
58 different procedural codes to reimburse oncology practices for office visits and
administration of drugs. CPOC would replace this with just 11 payment categories, a more
than 80% reduction in complexity.
4. Is It Feasible for Medicare to Pay Oncology Practices This Way?
Under CPOC, Medicare could pay oncology practices using the same claims processing
systems it uses today. Oncology practices would submit claims forms to Medicare for each
patient, just as they do today, but using a new set of 11 CPT/HCPCS codes in place of the 58
current E&M and chemotherapy administration codes. The oncology practice would
maintain the appropriate documentation supporting which billing codes it used on the claims
form, just as it does today for the CPT codes it currently uses. The practice would continue
to bill for drugs and other procedures using current J codes and other CPT codes.
Other physicians bill for “bundles” of services rather than individual services, and some also
bill for services in monthly increments. For example, Medicare pays surgeons a single
amount that covers both office visits and treatments for a specific procedure, and
nephrologists bill Medicare for a month of dialysis care of patients with End Stage Renal
Disease (ESRD) using sixteen different codes based on the patient’s age, where the treatment
is given, and how often the physician sees the patient.
5. Would CPOC Increase the Amount that Medicare and Other Payers Spend on
Oncology Care?
CPOC is designed to take the money that is currently being paid to oncology practices for
most of their services and provide it to them in a way that better matches the services that
oncology patients need. ASCO intends to recommend payment amounts to Medicare for
each of the components of CPOC such that total spending on oncology care for an oncology
practice’s patients, considering both what is paid to the oncology practice and what is paid
for other costs of oncology care to the practice’s patients (e.g., laboratory testing, imaging,
emergency room visits, hospitalizations, parenteral drugs, oral drugs, etc.) is no greater than
it would have been if the current payment system had continued.
6. Could Oncology Practices Receive Less Revenue Under CPOC?
CPOC will help oncology practices avoid losing revenue if they redesign care based on an
interdisciplinary team approach and use alternative ways for physicians to interact with
patients other than face-to-face visits. CPOC will also help oncology practices avoid losing
revenue if patients are given oral chemotherapy rather than parenteral drugs. In many cases,
oncology practices will be able to obtain additional revenue, such as through increases in
payments for delivering high-quality, evidence-based care, and compensating oncologists
when they serve as a patient’s hospice physician.
ASCO intends to carry out analyses in order to recommend payment amounts to Medicare for
each of the components of CPOC that would ensure the total net revenue a typical oncology
practice would receive under CPOC would be no less than under the current payment system.
ASCO expects that for many practices, net revenue to the practice could increase without
increasing total spending by Medicare or payers, because CPOC would help improve quality,
American Society of Clinical Oncology
Page | 2
Consolidated Payments for Oncology Care
Payment Reform to Support Patient-Centered Care for Cancer
_____________________________________________________________________________
reduce use of non-evidence based treatment, and reduce avoidable expenditures on
emergency room visits and hospitalization. Since net revenues to oncology practices
represent only a small proportion of the total spending on oncology care, even a small
reduction in other spending through better care for patients could allow oncology practices to
be paid more for their services than they are today.
ASCO believes that careful analyses should first be conducted in order to set appropriate
payment amounts for CPOC. Then practices should be able to phase in the new method of
payment, either by implementing it for specific subsets of patients or types of cancer first, or
by implementing it for all patients with limits on how much an oncology practice’s net
revenue could change from what they would have received under the current payment
system. Medicare spending and practice revenues would be monitored carefully and
adjustments would be made to correct to the structure and payment amounts under CPOC to
address any problems, similar to what is done by Medicare annually for the overall physician
fee schedule.
7. Does CPOC Do Anything to Reduce the High Cost of Oncology Care?
Under CPOC, oncology practices would use evidence-based pathways to help them and their
patients choose the most appropriate treatments, supportive care, testing, and other aspects of
care to achieve better outcomes. Research has shown that the use of such pathways reduces
spending without harming patients by reducing the use of inappropriate treatments. As they
become available, value-based pathways would also be used that identify the lowest-cost
treatment in situations where multiple treatments are available that have equivalent efficacy
and toxicity.
In addition, under CPOC, oncology practices would have greater flexibility to help patients
avoid complications that result in expensive emergency room visits and hospitalizations, and
practices whose patients have high rates of avoidable complications requiring emergency
room care would have their payments reduced. CPOC also includes an optional program to
provide extra resources to practices for additional services that can help patients avoid
expensive ER visits and hospitalizations.
8. Does CPOC Change the “Buy and Bill” System for Paying for Oncology Drugs?
The focus of CPOC is to restructure the payments oncology practices currently receive for
their time with patients so the practices can provide the types of care patients most need,
rather than only the things that are reimbursed, or the things that are reimbursed more
generously, under the current fee-for-service system. For example, one of the problems with
the current system of paying oncology practices is that they are paid more for using IV
therapies than for oral medications, even though patients taking oral medications also require
considerable amounts of education and support; CPOC would ensure that payments were
based on the level of services the patient needs for whatever type of medication they are
receiving.
Under CPOC, if an oncology practice purchases and stores parenteral drugs for
administration, the practice would be reimbursed for its cost of purchasing the drugs and it
would also receive adequate compensation for the practice’s expenses and risk associated
with purchasing and maintaining an inventory of expensive and potentially toxic drugs. In
American Society of Clinical Oncology
Page | 3
Consolidated Payments for Oncology Care
Payment Reform to Support Patient-Centered Care for Cancer
_____________________________________________________________________________
addition to the current system of paying based on the average sales price of drugs, ASCO
believes that one or more additional payment system should be developed that reimburse the
oncology practice for its costs of purchasing drugs for patients and provide adequate
compensation for the costs of safely maintaining an inventory of such drugs without making
the financial viability of the oncology practice dependent on the types of drugs it prescribes.
9. Would Fixed Monthly Payments Discourage Practices From Caring for Sicker Patients
and Patients Needing Complex Treatments?
The CPOC system is specifically designed to pay oncology practices more for caring for
patients with multiple health problems and for patients receiving complex treatment
regimens. Payment amounts would be higher during treatment months if a patient has other
health problems besides cancer, if they are unable to work or take care of themselves, if they
are receiving multiple drugs, and/or if they are receiving more toxic drugs.
10. How Could Patients and Payers Be Sure That Appropriate Care Was Being Given
Under CPOC?
Under CPOC, oncology practices would be measuring and reporting their use of evidencebased pathways, their performance on quality measures, and the rate at which their patients
experienced complications leading to avoidable, oncology-related emergency room visits. In
addition to their quality and performance being measured objectively, payments to a practice
would be reduced if its performance was significantly below that of other oncology practices.
11. How Does CPOC Differ From Bundled Payments and Episode Payments?
Consolidated Payments for Oncology Care “bundle” together all of the current payments that
oncology practices receive for the time they spend seeing patients and administering
treatments (i.e., evaluation and management payments, both in the office and in the hospital,
and chemotherapy administration payments, regardless of whether the drugs are administered
in the physician’s office or a separate infusion center). This gives the practice much greater
flexibility to deliver the types of services that patients need without the restrictions imposed
by current payment systems as to what kinds of services will be reimbursed. For example,
under CPOC, a physician could spend time answering a patient’s questions over the phone,
via email, or in a face-to-face office visit, whichever was more convenient for the patient,
whereas under the current payment system, the oncology practice would not be paid for a
discussion over the phone or through email.
A CPOC payment does not, however, “bundle” the costs of drugs, tests, hospitalizations, etc.
with the payments for the time of oncologists and their staff. These other costs would still be
reimbursed separately based on bills submitted by the oncology practice, the pharmacy, the
testing lab, the hospital, or whomever delivered that product or service.
Also, in contrast to an episode payment that would pay a fixed amount for treatment no
matter how many months it lasts, CPOC would give an oncology practice an additional
payment for a patient during each month that the patient is being cared for by the practice. If
an oncology practice and payer wanted to develop an episode payment for certain kinds of
cancers or treatments, CPOC could help by defining the appropriate amount of payment
American Society of Clinical Oncology
Page | 4
Consolidated Payments for Oncology Care
Payment Reform to Support Patient-Centered Care for Cancer
_____________________________________________________________________________
needed in each month for the time and costs that an oncology practice incurs to deliver highquality patient care (including services that are not currently reimbursed under fee-forservice). An appropriate episode or condition-based payment could then be constructed by
combining these monthly amounts over the time period that is to be covered by the episode
payment along with any other costs that are to be included in the episode payment. The
differences in the number of months of payments and the levels of payments that are made
for patients with different types and stages of cancer under the proposed oncology payment
model could be used to determine how to adjust the episode payment amounts by type and
stage of cancer.
12. Is CPOC Intended to Be an Alternative to an ACO for Oncologists?
CPOC is intended to help oncology practices improve care to cancer patients, whether the
practice or patient is part of an Accountable Care Organization (ACO) or not. CPOC could
be used to pay oncology practices inside an overall global payment for an ACO or as a
complement to a shared savings payment for an ACO, and indeed, CPOC would help both
the ACO and oncology practices be more successful by clearly defining what financial
support the oncologists need in terms of payment change to enable them to help achieve
better outcomes at lower costs.
13. Wouldn’t a Shared Savings Program Be Simpler and Also Save Money?
Shared savings programs do not make any changes to the way physicians are paid for
delivering care to patients. If Medicare or a health plan created a shared savings program for
cancer care, oncology practices would still only be paid for office visits with physicians and
administration of IV therapies, and not for many other essential services to patients, such as
telephone calls and emails with their physician, education and counseling services provided
by nurses, social workers, and financial counselors at the practice, or help in managing oral
chemotherapy.
ASCO’s plan for Consolidated Payments for Oncology Care includes an optional Shared
Savings Payment, but this would be in addition to the rest of the payment changes, not a
substitute for them. Moreover, giving oncology practices the flexibility to deliver the most
appropriate services to patients and basing payments on the use of evidence-based guidelines
and performance on quality measures, as CPOC would do, would assure cancer patients that
shared savings payments were not based on savings generated by withholding the treatment
they need.
14. Wouldn’t a Monthly Care Management Payment for Oncology Practices, Similar to
Primary Care Medical Home Programs, Be Simpler and Better?
Although oncology practices would welcome receiving additional revenues in a flexible
monthly payment, the add-on care management payments in most commercial primary care
medical home programs are very small, and so similar add-on payments in oncology would
still leave the oncology practice with insufficient revenues to cover the wide range of
services they provide that are not covered by payments for physician visits and drug
infusions, such as telephone calls and emails, education and counseling services, etc.
Moreover, because the intensity of services needed by patients varies dramatically from
American Society of Clinical Oncology
Page | 5
Consolidated Payments for Oncology Care
Payment Reform to Support Patient-Centered Care for Cancer
_____________________________________________________________________________
month to month based on whether they are currently receiving treatment and the nature of the
treatment they are receiving, a flat monthly payment for each patient would be unlikely to
match actual patient needs. In contrast, CPOC would replace existing payments with new
monthly payments that would vary from month to month based on patients’ needs.
15. Is CPOC Consistent with Proposed Congressional Payment Reform Legislation?
H.R. 4015, which received unanimous bipartisan support in the House Energy and
Commerce Committee, the House Ways and Means Committee, and the Senate Finance
Committee, encourages the use of Alternative Payment Models that base payments on
performance on quality measures and require physician practices to accept financial risk for
monetary losses. Consolidated Payments for Oncology Care would qualify as an Alternative
Payment Model under the legislation because it includes a Value-Based Payment Adjustment
that modifies payment to an oncology practice by up to 10% based on its performance on
quality measures, use of care pathways, and success in reducing avoidable emergency room
visits for patients.
American Society of Clinical Oncology
Page | 6
Molecular Diagnostics and Therapeutics in the Post‐genomic Era Jordan A. Shavit, MD, PhD Dr. Jordan Shavit is a Johnson Family Scholar and Assistant Professor of Pediatrics and Communicable Diseases at University of Michigan. Dr. Shavit’s interest is in “clinically directed basic research” in the field of hemostatic and thrombotic diseases. Dr. Shavit received his undergraduate degree in cell/molecular biology from the University of Michigan, his philosophy degree in biochemistry, molecular and cell biology from Northwestern University, and his medical degree from Northwestern University. He did his pediatric residency at the University of Michigan Mott Children’s Hospital and his fellowship at University of Michigan Division of Pediatric Hematology/Oncology. During his time at the University of Michigan, he has held numerous positions including lecturer in pediatrics and communicable diseases, a current Johnson Family Scholar of pediatrics and communicable diseases, assistant professor of pediatrics and communicable diseases, and a member of the University of Michigan Comprehensive Cancer Center as well as the University of Michigan Cardiovascular Center. Dr. Shavit served on the American Board of Pediatrics Certification in General Pediatrics, American Board of Pediatrics Certification in Pediatric Hematology/Oncology, National Hemophilia Foundation Graduated Fellows Advisory Board, Editorial Board, and Pediatric Blood & Cancer. He is a member of the American Society of Hematology, American Society of Pediatric Hematology/Oncology, American Heart Association, and the International Society of Thrombosis and Hemostasis. In 2008, Dr. Shavit was awarded the Young Investigator Award from the American Society of Pediatric Hematology/Oncology and also the Hemophilia & Thrombosis Research Society Mentored Research award. In 2009, he was awarded by the University of Michigan Biological Sciences Scholars Program as well as the Inaugural John Family Scholar of Pediatrics at the University of Michigan. He was awarded the top resident teacher award at the University of Michigan Department of Pediatrics from 2011‐2012. 7/16/2014
One day, two similar families,
Molecular diagnostics and therapeutics
in the post-genomic era
Jordan A. Shavit, M.D., Ph.D.
Assistant Professor
Pediatrics and Communicable Diseases
Comprehensive Cancer Center
Frankel Cardiovascular Center
University of Michigan
July 25, 2014
One day, two similar families,
two very different responses
• Case 1: 17 year old male, generally healthy
• Father sustained LE DVT and PE, associated with
C. Difficile secondary to frequent antibiotic use for
sinusitis, tested positive for factor V Leiden
• Referred for testing
• Case 2: 11 and 12 year old sisters, generally
healthy
• Father developed severe mesenteric thrombi after
gastric bypass surgery, heterozygous for
prothrombin G20210A
• Referred for testing
One day, two similar families,
two very different responses
• Case 1: spent >30 minutes, convinced mother and
patient of potential risks, and lack of benefit to testing
• Father called later and convinced him too
• Case 2: spent >30 minutes, mother became very upset
• Other physicians including PCP and adult hematologist
advised her to test daughters
• Wanted to do “everything possible” for children
• More upset when warned about possibility of lack of
insurance coverage for testing
• Outcome: was covered, one girl was heterozygous
One day, two similar families,
two very different responses
One day, two similar families,
two very different responses
• Excess cost
• Physician and patient frustration
1
8/14/2014
Inherited thrombophilia
MTHFR C677T
(one polymorphism to rule them all?)
• Others: lipoprotein(a), elevated homocysteine
• Disproven as risk factor:
• MTHFR C677T
• PAI-1 4G-5G polymorphism
ASH Teaching cases
MTHFR C677T
(one polymorphism to rule them all?)
Treatment of venous thrombosis
Indication
Rx with FVL
Rx without FVL
Primary prophylaxis
None
None
Acute Thrombosis
anticoagulation
anticoagulation
Prophylaxis after
1st event
Anticoagulation x3-12
months
Anticoagulation x3-12
months
Prophylaxis after
recurrent thrombosis
extended anticoag.
(?lifelong)
extended anticoag.
(?lifelong)
Pregnancy
?????
?????
Oral contraceptives/
estrogens
?? Relatively contraindicated (? or not)
Other special cases
?????
?????
ACCP guidelines do not generally suggest alteration of management
based on thrombophilic risk factors
Testing for Factor V Leiden
(and other thrombophilias)
• Current indications for testing
• neonatal purpura fulminans
• suspicion of antiphospholipid antibody syndrome
• Potential future indications:
– Choice and duration of primary therapy for thrombosis
– Choice and duration of thrombosis prophylaxis:
• During pregnancy
• Postoperative or hospitalized patients
• following 1st or subsequent thrombotic event
– Screening before OCP prescription
• Estimated number needed to screen for FVL to
prevent one case of thrombosis: 14,000
2
7/16/2014
Lots of tests:
when should we use them?
•
Blood 122: 3879, Dec 5, 2013.
•
•
Costs of single gene
genotyping/sequencing
•
•
•
•
•
•
•
Factor V Leiden (UH-Cleveland)
Factor V Leiden (Mayo)
Factor IX gene sequencing (Mayo)
MTHFR , FVL (Cleveland Clinic)
Factor VIII gene sequencing (Penn)
Factor IX gene sequencing (Penn)
Factor VIII/IX familial mutation (Penn)
Class I: test result will significantly alter medical
management
- Newborn screening (e.g. sickle cell, PKU)
- Some cancer predisposition syndromes
(e.g. VHL, MEN2, FAP, ?BRCA)
- Hemophilia pregnancy: route of delivery
Class III: test result will have no impact on
medical management
- Huntington Disease, Alzheimer predisposition
Class II: the grey zone
Costs of human whole exome sequencing
$114.80
$488.20
$1,809
$286
$1,350
$840
$360
•
•
•
•
•
PrimBio Research Institute
U. Rochester Genomics Center
Otogenetics, Inc.
Axeq Technologies, Inc.
Centrillion Biosciences, Inc.
-
$1,000
$1,676
$998
$650
$750
“Exome sequencing has been demonstrated as a cost effective tool in elucidating
the genetic causes of diseases”
• Gene by Gene
• Parabase Genomics
-
$895
$1,050
Clinical research exome $3,500, Clinical exome $5,000
• Variability in turnaround time, sequencing platform and
depth, type of report
www.scienceexchange.com
DNA Sequencing: Yield per Lane and Cost/Gigabase (Gb)
Sequencing costs over the last decade
40 Gb
$3200
Moore’s Law
17 Gb
$1500
10 Gb
$500
5 Gb
1.5 Gb
0.5 Gb
$40
Jan09
Jun09
Jan10
Jun10
Jan11
Sep11
Robert H. Lyons, UM Sequencing Core
Long fall: After many years of decline, the cost of sequencing a genome had
leveled off, but may dive again (dashed line) if Illumina's promise of
a $1000 genome holds up.
E Pennisi Science 2014;343:829-830
3
7/16/2014
Range of sequencing technologies
+++++
1 Tb
100 Gb
Oxford Nanopore?
Illumina
HiSeq 2500 V4
$1M / Gb
$10K/ Gb
Ion Proton?
10Gb
Total
data
yield
Classical (Sanger) sequencing
Illumina
HiSeq X
$3K/ Gb
Illumina
HiSeq 2000
$500/ Gb
MiSeq
$50/ Gb
1 Gb
$30?/ Gb
Ion Torrent
100 Mb
$25?/ Gb
PacBio RS
$10?/ Gb
1 Mb
$?/ Gb
Sanger
sequencing
100 kb
100
1000
10,000
100,000?
Read length
Robert H. Lyons, UM Sequencing Core
Next generation sequencing overview:
alignment
www.illumina.com
Next generation sequencing overview:
paired-end reads
www.illumina.com
www.scq.ubc.ca
en.wikipedia.org/wiki/DNA_sequencing
Next generation sequencing overview:
sample multiplexing
www.illumina.com
Next generation sequencing overview:
sequence assembly
en.wikipedia.org/wiki/DNA_sequencing
4
7/16/2014
Illumina sequencing
Ion Torrent sequencing
bitesizebio.com
http://en.wikipedia.org/wiki/Ion_semiconductor_sequencing
Oxford Nanopore Technologies
MinION, GridION
Oxford Nanopore Technologies
A
G
C
T
Next generation sequencing in pediatric
ALL: actionable outcome
•
•
•
•
•
•
PedMiOncoSeq: University of Michigan study led by Rajen Mody
(Pediatrics) and Arul Chinnaiyan (Pathology)
9 year old with pre-B ALL, multiply relapsed, s/p Allo BMT
Cytogenetics: t(4:12)(q27; Q23), add (9)(q34), add (17)(p13), FISH
Negative X 2 for MLL, BCR-ABL
Evaluated after 3rd relapse, discovered cryptic ETV6-ABL1 fusion,
observed rarely in ALL and CML, with variable responses to Imatinib
and Ponatinib
Patient cells shown to be responsive to Imatinib in vitro, and treatment
initiated
Clinical, cytogenetic, molecular remission lasting 20 months, although
recent recurrence
Next generation sequencing in pediatric
solid tumors: actionable outcome
• PedMiOncoSeq: 2 year old diagnosed with
medulloblastoma
• Treated with appropriate therapy, local recurrence
• Sequencing identified
-
-
fusion between PAX3 (known involvement in alveolar
rhabdomyosarcoma) and a nuclear receptor co-activator also
implicated in rhabdo
elevated expression of rhabdo and lower expression of medullo
markers
• Reclassified and now receiving rhabdomyosarcoma
therapy
5
7/16/2014
Lung Cancer Master Protocol
(Lung-MAP) trial
• Multi-drug, multi-arm, biomarker-driven clinical trial for
patients with advanced squamous cell lung cancer
• Sponsored by NCI, SWOG, 5 pharmaceuticals, and
several foundations
• Genomic profiling to match patients with investigational
treatments
• Targeted against genomic alterations believed to be
causative drivers of growth
• Will screen 500-1000 patients yearly for genomic
alterations in >200 cancer-related genes to assign one of
five therapeutic arms
Other uses ( = personalization)
•
•
•
•
•
What DO we mean by
“personalized medicine?”
• Harness the power of genetic information to:
1. Improve diagnosis
2. Tailor treatment to diagnosis
3. Identify disease susceptibility before illness
4. Facilitate preventive treatment
5. Facilitate treatment prescription with minimum
toxicity and maximum efficacy
(pharmacogenomics)
Segregate risk groups
Germline mutations
Somatic mutations
Gene expression (transcriptome)
Epigenetic changes (e.g. methylation, acetylation)
Direct to consumer (DTC) genetic testing
•
•
•
•
Mendelian genetic disorders
Pharmacogenomics
Complex (multigenic) disorders
Ancestry
Ng et al., Nature 461:724, 2009
6
8/14/2014
Is there any evidence that DTC genetic
testing will improve your health?
Testimonials:
•
“It convinced me to go to my doctor who found my prostate cancer.
____’s DTC genetic testing saved my life!!”
•
“When I found out about my increased risk of diabetes, I went out and
lost 30 pounds!!”
•
“When I found out about my increased risk of lung cancer, I stopped
smoking!!”
•
…
•
…
http://www.gao.gov/new.items/d10847t.pdf
Is there any evidence that DTC genetic
testing will improve your health?
Actual scientific evidence :
•
“It convinced me to go to my doctor who found my prostate cancer.
____’s DTC genetic testing saved my life!!”
•
“When I found out about my increased risk of diabetes, I went out and
lost 30 pounds!!”
•
“When I found out about my increased risk of lung cancer, I stopped
smoking!!”
•
…
•
…
NONE
The future…good
• Multiplexing of risk mutation analysis to reduce
costs (inter- and intrapatient)
• New/improved therapies
• Personalization
• Stratification
• Pharmacogenomics
• Complex computational analysis- combinatorial
risk factors
• Much larger data sets - health system wide
• Data to support genotype-specific
therapy/prophylaxis (personalized medicine)
• Newborn screens: whole genome sequencing
The future…(potential) bad
• Protection of data
-
Legal protection exists for health insurance
discrimination, but not life, disability, or long term care
• INFORMATICS: generation of data is outpacing
computational capacity
• DATA: proof that therapies work
• COSTS: justification based on evidence
• Proper education of providers
• Proper genetic counseling for patients
• Dealing with stress/anxiety
• Incidental genetic findings and their significance
• Moderate DTC genetic testing
7
7/16/2014
Acknowledgements
University of Michigan
Sam Silver
Rajen Mody
Arul Chinnaiyan
David Ginsburg
8
Medicare Coverage of Genomic Testing: Finding Clinical Unity Louis B. Jacques, MD Louis Jacques, M.D. is Chief Clinical Officer and a Senior Vice President at ADVI, where he is also a partner. ADVI is a health care advisory services firm with offices in Washington DC, Austin, and San Francisco. Before joining ADVI in 2014, Dr. Jacques was the Director of the Coverage and Analysis Group (CAG) in the Centers for Medicare & Medicaid Services (CMS) from 2009 ‐ 2014, where he managed Medicare fee for service coverage policy development on technologies as diverse as molecular diagnostic testing, advanced imaging, chemotherapeutics, wound care, and screening and preventive services. From 2004 – 2009 he was a division director within CAG. Before joining CMS in 2003, he served as the Associate Dean for Curriculum at Georgetown University School of Medicine; where he also saw patients at the Lombardi Cancer Center in his practice of hospice and palliative medicine. Jacques also made volunteer home visits for a hospice on Maryland’s Eastern Shore. While in active clinical practice he was a diplomate of both the American Board of Hospice and Palliative Medicine and the American Board of Family Medicine. He recertified his Family Medicine boards in 2013. Louis earned his undergraduate degree in 1978 from Georgetown University and his MD in 1982 from the University of Maryland. After completing his residency in family practice he served in a National Health Service Corps assignment in a Waterloo Iowa community health clinic. Before returning to the Washington DC area he worked in Detroit with the Henry Ford Medical Group and joined the faculty of the Wayne State University School of Medicine. 7/11/2014
Agenda
Medicare Coverage of Genomic Testing
Finding Clinical Utility
• Coverage Principles for Diagnostic Tests
• Specific Issues with MolDx Tests
–CMS MolDX Pilot
–PAMA (SGR Fix 2014)
Louis B. Jacques, MD
SVP & Chief Clinical Officer, ADVI
WASHINGTON DC
AUSTIN
SAN FRANCISCO
Givens
• Diagnostic tests per se are rarely therapeutic.
• Diagnostic testing per se may expose a patient to specific short‐ or long‐term risks. • The benefits and some potential harms of diagnostic testing accrue via its ability to inform downstream clinical management of the patient.
• The balance of risk and harm should consider the acuity and severity of the patient’s presentation.
• Avoidance of unnecessary or futile treatment can improve health outcomes. Social Security Act 1862(a)(1)
Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services—
(A) which, except for items and services described in a succeeding subparagraph or additional preventive services (as described in section 1395x(ddd)(1) of this title), are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,
***
(E) in the case of research conducted pursuant to section 1142, which is not reasonable and necessary to carry out the purposes of that section,
***
42 CFR 410.32
(a) Ordering diagnostic tests. All diagnostic x‐ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary (see §411.15(k)(1) of this chapter).
The Preferred Road to Diagnostic
Coverage
 Provide adequate evidence that
 The incremental information obtained by new
diagnostic technology compared to alternatives
 Changes physician recommendations
 Resulting in changes in therapy
 That improve clinically meaningful health
outcomes
 In Medicare beneficiaries
1
7/11/2014
Why would CMS embrace clinical utility?
Health Outcomes of Interest
More Impressive
• Well articulated paradigm:
– Well articulated in CDC, ACCE, EGAPP, SACGHS
– Lots of public input
– MEDCAC has endorsed it many times
• Consistent with prior NCD language:
– Improved health outcomes
– Fryback & Thornbury often cited in DMs
– Compatible with existing regulations (42CFR 410.32(a) about use my the treating physician.
Desirable Evidence
Diagnostic Imaging Evidence Hierarchy Level Genetic Testing Evidence Category
Example of Outcome Measures 1. Technical Efficacy
1. Analytic validity
Interpretable scan resolution, accuracy and reliability of tests of CSF proteins to measure CSF protein levels, inter‐reader and inter‐laboratory reliability of test results We often get
2. Diagnostic Accuracy
2. Clinical validity
3. Diagnostic Impression
Change in presumptive diagnosis following introduction of new test results 4. Diagnostic Action
Initiation or cessation of treatment; impact on use of additional diagnostic studies
We cope with
We really want
Sensitivity/specificity vs. gold standard test or vs. some other standard 5. Patient Outcomes 6. Societal Outcomes 3. Clinical utility
Cognitive/functional decline, time to institutionalization, side effects of treatment driven by test results, mortality • Longer life and improved function/participation
• Longer life with arrested decline
• Significant symptom improvement allowing better function/participation
• Reduced need for burdensome tests and treatments
Less Impressive
• Improved disease‐specific survival without improved overall survival
• Surrogate test result better
• Image looks better
• Doctor feels confident
Medicare has stated publicly that as a matter of policy that it does not generally
consider cost in making national coverage determinations.
Potential Test Platform Advantages
Compared to Current Practice
• Less invasive
• Clinically significant faster turnaround
• Reduced patient exposure to
radionuclide(s), allergens/sensitizers,
toxins etc.
• Clinically significant broader availability
(e.g. community based testing versus
sending to national reference lab)
Cost‐effectiveness of testing Companion Diagnostics
Thoughts on Companion Diagnostics
Development and Regulation
• “Actionability” argument is straightforward.
• Linking a drug to a specific test may narrow the
potential uses/market for the drug.
• Individual sponsors may not have both diagnostic and
therapeutic expertise in-house – may need to partner.
• Devices (like diagnostics) are characterized by iterative
change over their life cycles – drugs are fundamentally
more stable over their life cycle, though indications and
packaging may change.
2
7/11/2014
Thoughts on Companion Diagnostics
Coverage and Payment
• Coverage/coding/payment discussions will be about
both the test and the treatment and may cross Medicare
program benefit boundaries, e.g. Part B MACs deal with
the test and Part D plans deal with the drug.
• While the companion test is FDA-approved, there may
be “similar” LDTs that want to be treated like the FDAapproved diagnostic. But the LDT likely doesn’t have
the same evidence base or regulatory status.
PAMA Impacts Lab Tests Paid Under the Clinical Lab Fee Schedule (CLFS)
Payment Methodology
Unique HCPCS Coding for New Tests
CLFS Provisions
Local MAC Coverage Authority
Changes are Only Applicable to Clinical Lab Fee Schedule (CLFS)
Molecular Path
E.g. MAAA EGFR KRAS
Out of Scope
Anatomic Path
IHC
FISH Expert Advisory Panel Role
PAMA Establishes Two New Classes of Tests
Advanced diagnostic tests
Defined as a test furnished by a single lab and not sold for use by a lab other than the original developing lab and meets one of the following criteria:
• The test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient‐specific result
• The test is cleared or approved by the FDA
• The test meets other similar criteria established by the Secretary
Non‐advanced diagnostic tests
Everything else on the CLFS
• Advanced Diagnostic Tests • Coding at the specific test level
• New paradigm for payment calculation
• Advisory panels
In Scope
GAO and OIG Studies
GAO = Government
Accountability Office
OIG = Office of Inspector
General
MAC = Medicare Administrative
Contractor
The World After PAMA
Transition to New Payment Methodology for Existing Tests
New Payment Methodology Beginning January 1, 2017
Current Methodology
Under New Law
Crosswalk and Gapfill
Market based rate system
New Reporting Requirements Beginning January 1, 2016
Manufacturers of laboratory tests must report private payer payment rates (including rebates, discounts, etc.)
Report every 3 years for clinical diagnostic lab tests and annually for “advanced diagnostic tests”
3
7/11/2014
New Payment Rates Differ By Test Class
• Payment set at the weighted median (by volume) based on data collection
• Also applies to hospital lab tests paid separately and not part of a bundle
• Between 2017‐2019, payment amounts cannot be reduced by greater than 10%
• Between 2020‐2022, payments cannot be reduced by greater than 15% compared to the previous year
• Any other adjustments will no longer be applicable
• Geographic
• Budget neutrality
• Annual update
Existing Tests
New Non‐
Advanced Diagnostic Laboratory Tests
• During initial payment period until the market rate is set, payment will be determined using either
• Crosswalk to appropriate existing codes on the fee schedule or
• Gapfill if no comparable tests exist
• The Secretary may also consider recommendations from a panel and make public an explanation of the payment rate
New Advanced Diagnostic Laboratory Tests
• For an initial period of three quarters, payment will be passed on the actual list charge for the lab test
• After the initial list charge payment period, payment will be based on a weighted medium of the reported data
• If the list price is greater than 130% of the established market rate, the Secretary will recoup the different between the payment amounts furnished during the initial period
CMS Creating New HCPCS Codes
Existing Tests
New Tests
•Existing advanced diagnostics and tests that are FDA cleared or approved that do not have a unique HCPCS code (i.e. tests paid under a miscellaneous code) will be assigned a unique HCPCS code by the Secretary by January 1, 2016 • CMS may adopt temporary Healthcare Common Procedural Coding System (HCPCS) codes to identify new advanced tests and
new tests that are FDA cleared or approved
• Only in effect until a permanent HCPCS code is created, not to exceed 2 years
GAO and OIG Must Assess New Payment Methodology
Advisory Panel for Payment and Coverage
 By July 1, 2015, the Secretary shall consult with an expert advisory panel to collect input on the establishment of payment rates for new clinical diagnostic tests, the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests, and any other recommendations.
− The panel will consist of experts such as molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics.
By October 1, 2018, report to Congress must include:
• Payment rates paid by private payers for laboratory tests;
• Conversion to new payment rates under the methodology proposed;
• Impact of these changes on beneficiary access;
• Impact on low volume laboratories and those that specialize in a small number of tests;
• Number of new HCPCS codes issued;
GAO
OIG
•
•
Spending trend of laboratory tests under this policy;
The initial list price and subsequent reported rates for tests;
•
Changes in the number of advanced laboratory tests cleared or approved by the FDA; and healthcare economic information.


Annual analysis
Analysis must include:
 The top 25 laboratory tests by expenditures
 Analyses conducted with respect to the implementation and effect of the new payment system for laboratory tests created by this bill
Studies must be conducted to ensure that the new payment methodologies result in cost savings to the Medicare program and do not harm to beneficiary access or clinical decision making. Louis B. Jacques, MD
SVP & Chief Clinical Officer,
ADVI
ADVI.COM
202 509 0760
1050 K St, NW
Suite 340
WASHINGTON, DC 20001
Louis.Jacques@ADVI.COM
4
Meeting Wrap Up American Society of Hematology American Society of Clinical Oncology www.hematology.org www.asco.org ASH/ASCO CAC Resources from CMS Medicare’s Program Integrity Manual, Chapter 13, which outlines the local coverage
determinations, the Carrier Advisory Committee (CAC), and contractor responsibilities
surrounding CACs - http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/pim83c13.pdf
General Information on CMS’ Contracting Reform - http://www.cms.gov/Medicare/MedicareContracting/MedicareContractingReform/index.html
Medicare Administrative Contractors (MAC) Regions and updates http://www.cms.gov/Medicare/MedicareContracting/MedicareContractingReform/PartAandPartBMACJurisdictions.html
Map of Current Jurisdictions - http://www.cms.gov/Medicare/MedicareContracting/MedicareContractingReform/JurisdictionMaps/Primary_AB_MAC_Jurisdictions_MAP.pdf
Map of Consolidated Regions (what CMS is moving toward) http://www.cms.gov/Medicare/Medicare-Contracting/MedicareContractingReform/JurisdictionMaps/ConsolidatedABMACMap.pdf
Information on MAC Implementation (last updated April 2013) http://www.cms.gov/Medicare/MedicareContracting/MedicareContractingReform/MACImplementationSchedule.html
Documents relating to the procurement and implementation of MACs http://www.cms.gov/Medicare/Medicare-Contracting/MedicareContractingReform/A-B-MACProcurement-and-Implementation.html
Durable Medical Equipment MACs - http://www.cms.gov/Medicare/MedicareContracting/MedicareContractingReform/DurableMedicalEquipmentMedicareAdministrativeCont
ractor.html
Medicare Coverage - http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html
Medicare Coverage Center - http://www.cms.gov/Center/Special-Topic/Medicare-CoverageCenter.html
American Society of Hematology’s
Online Practice-Related Resources for CAC Representatives
ASH offers a wide range of practice-related resources on its website (www.hematology.org).
Below, please find a list of resources that may be of interest to you.
Resources for Clinicians Section on ASH Website (http://www.hematology.org/Clinicians/)
This page on the ASH website consolidates information for practitioners and provides the following links:

Guidelines for ITP; Epoetin and Darbepoetin; Heparin-Induced Thrombocytopenia; von Willebrand
Disease; Stem Cell Research – Evidence-based guidelines, quick reference tools and mobile downloads of
ASH Guides.

ASH On Demand – ASH On Demand is multimedia platform in which users can browse, purchase, and view
a variety of ASH educational content. The portal includes PowerPoint slides, audio, and/or video from a
number of ASH-wide programs – including annual meetings, regional meetings, and webinars.

Physician Quality Reporting System (PQRS) Resources – Up to date information on Medicare’s PQRS and
measures appropriate for use by hematologists.

Maintenance of Certification Tools – Important online tools to assist practitioners in earning credits toward
maintaining board certification – ASH Self-Assessment Program and practice improvement modules.

Drug Resources – Updates on the status of hematologic drug shortages, resources for physicians dealing with
shortages, and links to ASH/FDA webinars featuring an unbiased discussion of newly approved drugs and
their uses.

ICD-10 Conversion for Hematology – ASH will help members prepare for the transition by providing
complete conversion charts for all disorders related to hematology.

Sunshine Act and Open Payments Program – This resource provides resources to help members understand
the program, important dates, and links to the CMS Open Payments webpage and registration instructions.

Consult a Colleague – A member service designed to help facilitate the exchange of information between
hematologists and their peers.
ASH Advocacy Center
ASH’s redesigned Advocacy Center houses all the Society’s policy positions, advocacy efforts, and campaigns.
Hematologists and their patients can follow the latest national policy news and directly campaign their representatives
through ASH Action Alerts. The Center also displays ASH’s official policy statements along with testimony and
correspondence related to federal regulation and private insurance developments.
Lastly, members wishing to gain a better understanding of the Society’s activities and learn about legislation and
health policy affecting hematology research and practice can sign up for the Advocacy Leadership Institute. This twoday workshop features guest speakers from Congress and the Administration, including the National Institutes of
Health as well as other health agency officials. On the second day, participants will visit their congressional delegation
on Capitol Hill. Nominations are accepted every July for the workshops in October.
ASH Publications

ASH Practice Updates – The Practice Update is the society’s bi-monthly e-newsletter reporting on breaking
news and activities of interest to the practice community.
ASH’s Online Practice-Related Resources (Continued)

The Hematologist: ASH News and Reports – An award-winning bimonthly publication that updates readers
about important developments in the field of hematology and highlights what ASH is doing for its members.

Blood – ASH’s journal, published weekly, can be accessed in print and online. Section of Interest to
Clinicians: Inside Blood – This special section of the Journal provides succinct summaries of cutting-edge
topics, especially those that hold promise for future clinical application.
Meeting Information

ASH Annual Meeting and Exposition – Information concerning registration, housing, and meeting content
for the Society’s Annual Meeting and Exposition designed to provide hematologists from around the world a
forum for discussing critical issues in the field. Abstracts presented at the meeting also contain the latest and
most exciting developments in hematology research.

Consultative Hematology Course – Information concerning registration, housing, and meeting content for this
intensive half-day program, which focuses on updates in non-malignant hematology designed for practitioners
who are trained as hematologists or hematologist-oncologists, but now see patents with non-malignant
hematologic conditions on a less frequent basis.

State-of-the-Art Symposia – Information concerning registration, housing, and meeting content for this ASHsponsored meeting designed to present current developments in malignant hematology.

Highlights of ASH – Information concerning registration, housing, and meeting content for this ASHsponsored meeting designed to provide the highlights of the top presentations from the recent annual meeting.
American Society of Hematology
Five Things Physicians
and Patients Should Question
Don’t transfuse more than the minimum number of red blood cell (RBC)
units necessary to relieve symptoms of anemia or to return a patient to a
safe hemoglobin range (7 to 8 g/dL in stable, non-cardiac in-patients).
1
Transfusion of the smallest effective dose of RBCs is recommended because liberal transfusion strategies do not improve outcomes when compared to
restrictive strategies. Unnecessary transfusion generates costs and exposes patients to potential adverse effects without any likelihood of benefit. Clinicians
are urged to avoid the routine administration of 2 units of RBCs if 1 unit is sufficient and to use appropriate weight-based dosing of RBCs in children.
2
Don’t test for thrombophilia in adult patients with venous
thromboembolism (VTE) occurring in the setting of major
transient risk factors (surgery, trauma or prolonged immobility).
Thrombophilia testing is costly and can result in harm to patients if the duration of anticoagulation is inappropriately prolonged or if patients are
incorrectly labeled as thrombophilic. Thrombophilia testing does not change the management of VTEs occurring in the setting of major transient VTE
risk factors. When VTE occurs in the setting of pregnancy or hormonal therapy, or when there is a strong family history plus a major transient risk factor,
the role of thrombophilia testing is complex and patients and clinicians are advised to seek guidance from an expert in VTE.
Don’t use inferior vena cava (IVC) filters routinely in patients with acute VTE.
3
4
IVC filters are costly, can cause harm and do not have a strong evidentiary basis. The main indication for IVC filters is patients with acute VTE and
a contraindication to anticoagulation such as active bleeding or a high risk of anticoagulant-associated bleeding. Lesser indications that may be
reasonable in some cases include patients experiencing pulmonary embolism (PE) despite appropriate, therapeutic anticoagulation, or patients with
massive PE and poor cardiopulmonary reserve. Retrievable filters are recommended over permanent filters with removal of the filter when the risk for
PE has resolved and/or when anticoagulation can be safely resumed.
Don’t administer plasma or prothrombin complex concentrates for
non-emergent reversal of vitamin K antagonists (i.e. outside of the setting
of major bleeding, intracranial hemorrhage or anticipated emergent surgery).
Blood products can cause serious harm to patients, are costly and are rarely indicated in the reversal of vitamin K antagonists. In non-emergent
situations, elevations in the international normalized ratio are best addressed by holding the vitamin K antagonist and/or by administering vitamin K.
5
Limit surveillance computed tomography (CT) scans in asymptomatic
patients following curative-intent treatment for aggressive lymphoma.
CT surveillance in asymptomatic patients in remission from aggressive non-Hodgkin lymphoma may be harmful through a small but cumulative risk of
radiation-induced malignancy. It is also costly and has not been demonstrated to improve survival. Physicians are encouraged to carefully weigh the
anticipated benefits of post-treatment CT scans against the potential harm of radiation exposure. Due to a decreasing probability of relapse with the passage
of time and a lack of proven benefit, CT scans in asymptomatic patients more than 2 years beyond the completion of treatment are rarely advisable.
These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items
on this list or their individual situation should consult their physician.
How This List Was Created
The American Society of Hematology (ASH) Choosing Wisely® Task Force utilized a modified Delphi technique to collect suggestions from committee members and
recipients of its clinically focused newsletter, the ASH Practice Update. Respondents were asked to consider the core values of harm, cost, strength of evidence,
frequency and control. Fifty-nine of 167 ASH committee members (35%) and 2 recipients of the ASH Practice Update submitted 81 unique suggestions. The Task
Force used a nominal group technique (NGT) to identify the top 20 items, which were scored by ASH committee and practice community members, with a 46 percent
participation rate. ASH’s Task Force reviewed all scores to develop a 10-item list. A professional methodologist conducted a systematic literature review on each
of the 10 items; the Task Force chair served as the second reviewer. Evidence reviews and source material for the 10 items were shared with ASH’s Task Force,
which ranked the items according to the core values. The Task Force then identified the top 5 items plus 1 alternate. ASH member content experts provided
external validation for the veracity and clarity of the items.
ASH’s disclosure and conflict of interest policy can be found at www.hematology.org.
Sources
1
Carson JL, Grossman BJ, Kleinman S, Tinmouth AT, Marques MB, Fung MK, Holcomb JB, Illoh O, Kaplan LJ, Katz LM, Rao SV, Roback JD, Shander A, Tobian AA,
Weinstein R, Swinton McLaughlin LG, Djulbegovic B; Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion: a clinical practice guideline
from the AABB. Ann Intern Med. 2012 Jul 3;157(1):49–58.
Retter A, Wyncoll D, Pearse R, Carson D, McKechnie S, Stanworth S, Allard S, Thomas D, Walsh T; British Committee for Standards in Hematology. Guidelines on the
management of anaemia and red cell transfusion in adult critically ill patients. Br J Haematol. 2013 Feb;160(4):445–64.
2
Chong LY, Fenu E, Stansby G, Hodgkinson S. Management of venous thromboembolic diseases and the role of thrombophilia testing: summary of NICE guidance.
BMJ. 2012 Jun 27;344:e3979.
Baglin T, Gray E, Greaves M, Hunt BJ, Keeling D, Machin S, Mackie I, Makris M, Nokes T, Perry D, Tait RC, Walker I, Watson H; British Committee for Standards in
Hematology. Clinical guidelines for testing for heritable thrombophilia. Br J Haematol. 2010 Apr;149(2):209–20.
3
Dupras D, Bluhm J, Felty C, Hansen C, Johnson T, Lim K, Maddali S, Marshall P, Messner P, Skeik N. Venous thromboembolism diagnosis and treatment.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2013 Jan. 90 p.
Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR; American College of Chest
Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S–94S.
National Institute for Health and Clinical Excellence (NICE). Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role
of thrombophilia testing. 2012 Jun:NICE clinical guideline;no.144.
Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK;
American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular
Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism,
iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation.
2011 Apr 26;123(16):1788–830.
4
Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH; American College of Chest Physicians.
Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e152S–84S.
Scottish Intercollegiate Guidelines Network (SIGN). Antithrombotics: indications and management. Edinburgh (UK): 2012. 75 p. Report No. 129.
5
Zelenetz AD, Wierda WG, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Bellam N, Byrd JC, Czuczman MS, Fayad LE, Glenn MJ, Gockerman JP, Gordon LI, Harris NL,
Hoppe RT, Horwitz SM, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Nademanee A, Porcu P, Press O, Pro B, Reddy N, Sokol L, Swinnen L, Tsien C, Vose JM, Yahalom J,
Zafar N, Dwyer MA, Naganuma M; National Comprehensive Cancer Network. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology:
non-Hodgkin’s lymphomas: Version 1.2013. Fort Washington (PA): NCCN.2013.
Lin TL, Kuo MC, Shih LY, Dunn P, Wang PN, Wu JH, Tang TC, Chang H, Hung YS, Lu SC. Value of surveillance computed tomography in the follow-up of diffuse large B-cell
and follicular lymphomas. Ann Hematol. 2012 Nov;91(11):1741–5.
Guppy AE, Tebbutt NC, Norman A, Cunningham D. The role of surveillance CT scans in patients with diffuse large B-cell non-Hodgkin’s lymphoma. Leuk Lymphoma.
2003 Jan;44(1):123–5.
Shenoy P, Sinha R, Tumeh JW, Lechowicz MJ, Flowers CR. Surveillance computed tomography scans for patients with lymphoma: is the risk worth the benefits?
Clin Lymphoma Myeloma Leuk. 2010 Aug;10(4):270–7.
About the ABIM Foundation
About the American Society of Hematology
The mission of the ABIM Foundation is to advance
medical professionalism to improve the health
care system. We achieve this by collaborating with
physicians and physician leaders, medical trainees,
health care delivery systems, payers, policymakers,
consumer organizations and patients to foster a shared
understanding of professionalism and how they can
adopt the tenets of professionalism in practice.
The American Society of Hematology (ASH) is the world’s
largest professional society of hematologists, serving more
than 14,000 clinicians and scientists from around the world
who are dedicated to furthering the understanding, diagnosis,
treatment and prevention of disorders affecting the blood.
To learn more about the ABIM Foundation, visit www.abimfoundation.org.
®
For more than 50 years, the Society has led the development of
hematology as a discipline by promoting research, patient care, education,
training and advocacy in hematology. By providing a forum for clinicians
and scientists to share the latest discoveries in the field, ASH is helping to
improve care and possibly lead to cures for diseases that affect millions of
people, including leukemia, lymphoma, myeloma, anemias and various
bleeding and clotting disorders.
For more information, visit www.hematology.org.
For more information or to see other lists of Five Things Physicians and Patients Should Question, visit www.choosingwisely.org.
ASCO Advocacy
ASCO in Action (AiA) –ASCO has dedicated a portion of its website to spotlight timely
information on research policy, clinical affairs, government relations, and quality of care issues
that affect oncology practice, cancer care, and cancer research. ASCO publishes AiA briefs and
alerts and these are all available at http://ascoaction.asco.org/
ASCO’s ACT Network – This project provides members different opportunities to become
engaged in advocacy. The ASCO ACT Network allows individuals to send a message using the
pre-drafted editable alerts, find phone numbers and mailing addresses for elected officials, see
how members of Congress voted on key issues, and draft a message (e-mail or letter) to a
member of Congress. http://ascoaction.asco.org/AdvocacyTools.aspx
Advocacy Toolkit – The toolkit provides information about effectively communicating and
establishing a relationship with members of Congress. It includes details on how to effectively
organize a visit, schedule and participate in a meeting with a member of Congress, and how to
write a meaningful letter/e-mail that will get the member’s attention. (The toolkit is for members
only.) http://www.asco.org/advocacy/ascos-advocacy-toolkit
Practice-Related Items
ASCO’s Coding & Reimbursement Service - ASCO offers a service to answer oncologyrelated coding, billing and reimbursement inquiries. The coding and reimbursement service is
offered electronically and can be accessed at www.asco.org/billingcoding. The service is
available to ASCO members and their office staff as a member benefit, and a valid ASCO
member number must be provided when using the online e-form. The service is also available
to non-members for a nominal fee per inquiry.
Oncology Practice Insider - The Oncology Practice Insider (OPI) is a bi-monthly ecommunication specifically devoted to oncology practice management issues. The Insider
provides updates on Medicare initiatives, drug shortages, regulations affecting physician
practices, legislative activities, coverage information, billing and coding, and more. To view the
most recent editions of the OPI, visit http://www.asco.org/advocacy-practice/practicemanagement. To subscribe to this free oncology management e-communication e-mail
practice@asco.org. Journal of Oncology Practice - The Journal of Oncology Practice (JOP) provides oncologists
and other oncology professionals with information, news, research and tools to enhance
practice efficiency and promote quality in cancer care. The JOP includes original research,
feature articles, and columns on various issues pertinent to daily practice operations, all of
which are subject to peer review. For more information about JOP visit http://jop.ascopubs.org.
CAC Program
Dedicated information for Carrier Advisory Committee (CAC) representatives and related CAC
activities can be found on the ASCO website at http://www.asco.org/advocacypractice/medicare-program under the CAC Program. The goal is to provide educational
information, assist CAC representatives in networking and to facilitate contact between ASCO
members and their various state representatives.
Institute for Quality
ASCO has developed the Institute for Quality which compiles the organization’s quality projects
and initiatives under one umbrella. Some of the initiatives are highlighted below.
Clinical practice guidelines, Provisional Clinical Opinions (PCOs) and guideline endorsements
are available for practitioners outlining appropriate methods of treatment and care. ASCO expert
panels identify and develop practice recommendations for specific areas of cancer care that
would benefit from using practice guidelines. http://www.asco.org/institute-quality/guidelines
ASCO’s Quality Oncology Practice Initiative (QOPI®) is an oncologist-led practice-based quality
assessment and improvement program. http://qopi.asco.org/
ASCO’s QOPI® Certification Program (QCP) provides a three-year certification for outpatient
hematology-oncology practices that are committed to delivering high quality cancer care.
http://qopi.asco.org/certification.html
CancerLinQ – The Learning Intelligence Network for Quality is ASCO’s multi-phase initiative
that promises to change the way cancer is treated. This learning health system will connect
oncology practice, measure quality and performance, and provide physicians with decision
support in real time. http://www.asco.org/institute-quality/cancerlinq
ASCO State of Cancer Care
This year, ASCO released the State of Cancer Care in America: 2014. It is the first-ever,
comprehensive look at demographic, economic, and oncology practice trends that will impact
cancer care in the United States over the coming years.
With recommendations for addressing the cancer care delivery system’s most pressing
concerns, this landmark ASCO report also examines the rapid expansion of health information
technology and the growing emphasis on quality measurement and value.
ASCO developed the State of Cancer Care in America: 2014 report to help cancer care
providers, policy makers, and other more effectively shape the future of cancer care during
these uncertain times. The Society will issue annual updates that will track trends and identify
emerging issues.
For a full report published in the Journal of Oncology Practice and additional report content, visit
http://www.asco.org/practice-research/cancer-care-america
ASCO SERVICES FOR STATE AFFILIATES
ASCO is committed to supporting its 48 State/Regional Affiliates, and encourages its members to become engaged in local
activities by joining their state oncology society. Strong state societies are a vital component to effective advocacy and a
critical resource for addressing issues of concern to the cancer community. To better support the activities of each
state/regional oncology society, ASCO offers several services and benefits to its Affiliates, including:
Coding & Reimbursement Assistance
ASCO staff is available to assist members and their office staff on coding, coverage, and reimbursement uses.
CAC Network Meeting and Medicare Coverage Policies by State
Information about your local Medicare contractor, CAC representatives, and local state oncology/hematology society.
Read the monthly CAC e-newsletter and learn how to research oncology and hematology-related local coverage
determinations (LCDs) by state and subject.
Practical Tips for the Oncology Practice
Practical Tip is one of ASCO’s best resources for your practice with useful content that answers the most commonly asked
billing, coding, and reimbursement questions related to oncology services. The publication also addresses the regulations
that impact an oncology practice. The book is directed to both physicians and their office staff. Its practical content can be
applied in day-to-day operations
Legislative & Regulatory Activities
Federal and state policy development, grassroots advocacy campaigns, partnerships with patient advocacy groups.
Media
ASCO provides assistance to State/Regional Affiliates in contacting members of the local media, and offers training sessions
on specific issues in order to prepare potential spokespeople in communicating their message.
Meetings
ASCO provides meeting services assistance. You may request an ASCO speaker, continuing education tools and search
the calendar of events sponsored by state/regional oncology societies and ASCO.
Membership Recruitment & Benefits Assistance
Recruitment efforts, web site development, content for state society newsletters. State society members may request one
complimentary ASCO membership list per year to assist them in recruiting new members in their state.
State Affiliate Handbook
A guide for managing state oncology societies.
State Oncology Societies Booth
ASCO provides complimentary exhibit space for state society representatives at the ASCO Annual Meeting,
providing societies with the opportunity to showcase their organizations.
Web Site Development
ASCO has designed a template for state societies to create a web site for their organization. This service enables
societies to have a presence on the internet for their members as well as the general public.
American Society of Clinical Oncology
Five Things Physicians
and Patients Should Question
The American Society of Clinical Oncology (ASCO) is a medical professional oncology society committed to conquering cancer through research, education, prevention and
delivery of high-quality patient care. ASCO recognizes the importance of evidence-based cancer care and making wise choices in the diagnosis and management of patients
with cancer. After careful consideration by experienced oncologists, ASCO highlights ten categories of tests, procedures and/or treatments whose common use and clinical
value are not supported by available evidence. These test and treatment options should not be administered unless the physician and patient have carefully considered if their
use is appropriate in the individual case. As an example, when a patient is enrolled in a clinical trial, these tests, treatments and procedures may be part of the trial protocol and
therefore deemed necessary for the patient’s participation in the trial.
These items are provided solely for informational purposes and are not intended to replace a medical professional’s independent judgment or as a substitute for consultation with
a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their health care provider. New evidence may
emerge following the development of these items. ASCO is not responsible for any injury or damage arising out of or related to any use of these items or to any errors or omissions.
1
Don’t use cancer-directed therapy for solid tumor patients with the following
characteristics: low performance status (3 or 4), no benefit from prior
evidence-based interventions, not eligible for a clinical trial, and no strong
evidence supporting the clinical value of further anti-cancer treatment.
΄ Studies show that cancer directed treatments are likely to be ineffective for solid tumor patients who meet the above stated criteria.
΄ Exceptions include patients with functional limitations due to other conditions resulting in a low performance status or those with disease characteristics
(e.g., mutations) that suggest a high likelihood of response to therapy.
΄ Implementation of this approach should be accompanied with appropriate palliative and supportive care.
Don’t perform PET, CT, and radionuclide bone scans in the staging of
early prostate cancer at low risk for metastasis.
2
΄ Imaging with PET, CT, or radionuclide bone scans can be useful in the staging of specific cancer types. However, these tests are often used in the staging
evaluation of low-risk cancers, despite a lack of evidence suggesting they improve detection of metastatic disease or survival.
΄ Evidence does not support the use of these scans for staging of newly diagnosed low grade carcinoma of the prostate (Stage T1c/T2a, prostate-specific
antigen (PSA) <10 ng/ml, Gleason score less than or equal to 6) with low risk of distant metastasis.
΄ Unnecessary imaging can lead to harm through unnecessary invasive procedures, over-treatment, unnecessary radiation exposure, and misdiagnosis.
Don’t perform PET, CT, and radionuclide bone scans in the staging of
early breast cancer at low risk for metastasis.
3
΄ Imaging with PET, CT, or radionuclide bone scans can be useful in the staging of specific cancer types. However, these tests are often used in the staging
evaluation of low-risk cancers, despite a lack of evidence suggesting they improve detection of metastatic disease or survival.
΄ In breast cancer, for example, there is a lack of evidence demonstrating a benefit for the use of PET, CT, or radionuclide bone scans in asymptomatic
individuals with newly identified ductal carcinoma in situ (DCIS), or clinical stage I or II disease.
΄ Unnecessary imaging can lead to harm through unnecessary invasive procedures, over-treatment, unnecessary radiation exposure, and misdiagnosis.
4
5
Don’t perform surveillance testing (biomarkers) or imaging (PET, CT, and
radionuclide bone scans) for asymptomatic individuals who have been
treated for breast cancer with curative intent.
΄ Surveillance testing with serum tumor markers or imaging has been shown to have clinical value for certain cancers (e.g., colorectal). However for breast
cancer that has been treated with curative intent, several studies have shown there is no benefit from routine imaging or serial measurement of serum tumor
markers in asymptomatic patients.
΄ False-positive tests can lead to harm through unnecessary invasive procedures, over-treatment, unnecessary radiation exposure, and misdiagnosis.
Don’t use white cell stimulating factors for primary prevention of febrile
neutropenia for patients with less than 20 percent risk for this complication.
΄ ASCO guidelines recommend using white cell stimulating factors when the risk of febrile neutropenia, secondary to a recommended chemotherapy regimen,
is approximately 20 percent and equally effective treatment programs that do not require white cell stimulating factors are unavailable.
΄ Exceptions should be made when using regimens that have a lower chance of causing febrile neutropenia if it is determined that the patient is at high risk for
this complication (due to age, medical history, or disease characteristics).
Disclaimer: These items are provided solely for informational purposes and are not intended to replace a medical professional’s independent judgement or as a substitute for consultation with a
medical professional. Patients with any speciŬc questions about the items on this list or their individual situation should consult their health care provider.
American Society of Clinical Oncology
Five More Things Physicians
and Patients Should Question
Don’t give patients starting on a chemotherapy regimen that has a low or
moderate risk of causing nausea and vomiting antiemetic drugs intended
for use with a regimen that has a high risk of causing nausea and vomiting.
6
7
8
΄ Over the past several years, a large number of effective drugs with fewer side effects have been developed to prevent nausea and vomiting from
chemotherapy. When successful, these medications can help patients avoid spending time in the hospital, improve their quality of life and lead to
fewer changes in the chemotherapy regimen.
΄ Oncologists customarily use different antiemetic drugs depending on the likelihood (low, moderate or high) for a particular chemotherapy program
to cause nausea and vomiting. For chemotherapy programs that are likely to produce severe and persistent nausea and vomiting, there are new
agents that can prevent this side effect. However, these drugs are very expensive and not devoid of side effects. For this reason, these drugs should
be used only when the chemotherapy drugs that have a high likelihood of causing severe or persistent nausea and vomiting.
΄ When using chemotherapy that is less likely to cause nausea and vomiting, there are other effective drugs available at a lower cost.
Don’t use combination chemotherapy (multiple drugs) instead of chemotherapy
with one drug when treating an individual for metastatic breast cancer unless
the patient needs a rapid response to relieve tumor-related symptoms.
΄ Although chemotherapy with multiple drugs, or combination chemotherapy, for metastatic breast cancer may slow tumor growth for a somewhat longer time
than occurs when treating with a single agent, use of combination chemotherapy has not been shown to increase overall survival. In fact, the trade-offs
of more frequent and severe side effects may have a net effect of worsening a patient’s quality of life, necessitating a reduction in the dose of chemotherapy.
΄ Combination chemotherapy may be useful and worth the risk of more side effects in situations in which the cancer burden must be reduced quickly
because it is causing significant symptoms or is life threatening. As a general rule, however, giving effective drugs one at a time lowers the risk of side
effects, may improve a patient’s quality of life, and does not typically compromise overall survival.
Avoid using PET or PET-CT scanning as part of routine follow-up care
to monitor for a cancer recurrence in asymptomatic patients who have
finished initial treatment to eliminate the cancer unless there is high-level
evidence that such imaging will change the outcome.
΄ PET and PET-CT are used to diagnose, stage and monitor how well treatment is working. Available evidence from clinical studies suggests that using
these tests to monitor for recurrence does not improve outcomes and therefore generally is not recommended for this purpose.
΄ False positive tests can lead to unnecessary and invasive procedures, overtreatment, unnecessary radiation exposure and incorrect diagnoses.
΄ Until high level evidence demonstrates that routine surveillance with PET or PET-CT scans helps prolong life or promote well-being after treatment
for a specific type of cancer, this practice should not be done.
Don’t perform PSA testing for prostate cancer screening in men with no
symptoms of the disease when they are expected to live less than 10 years.
9
΄ Since PSA levels in the blood have been linked with prostate cancer, many doctors have used repeated PSA tests in the hope of finding “early” prostate
cancer in men with no symptoms of the disease. Unfortunately, PSA is not as useful for screening as many have hoped because many men with prostate
cancer do not have high PSA levels, and other conditions that are not cancer (such as benign prostate hyperplasia) can also increase PSA levels.
΄ Desearch has shown that men who receive PSA testing are less likely to die specifically from prostate cancer. However when accounting for deaths
from all causes, no lives are saved, meaning that men who receive PSA screening have not been shown to live longer than men who do not have
PSA screening. Men with medical conditions that limit their life expectancy to less than 10 years are unlikely to benefit from PSA screening as their
probability of dying from the underlying medical problem is greater than the chance of dying from asymptomatic prostate cancer.
Don’t use a targeted therapy intended for use against a specific genetic
aberration unless a patient’s tumor cells have a specific biomarker that
predicts an effective response to the targeted therapy.
10
΄ Unlike chemotherapy, targeted therapy can significantly benefit people with cancer because it can target specific gene products, i.e., proteins that
cancer cells use to grow and spread, while causing little or no harm to healthy cells. Patients who are most likely to benefit from targeted therapy are
those who have a specific biomarker in their tumor cells that indicates the presence or absence of a specific gene alteration that makes the tumor
cells susceptible to the targeted agent.
΄ Compared to chemotherapy, the cost of targeted therapy is generally higher, as these treatments are newer, more expensive to produce and under
patent protection. In addition, like all anti-cancer therapies, there are risks to using targeted agents when there is no evidence to support their use
because of the potential for serious side effects or reduced efficacy compared with other treatment options.
Abbreviations
CT, computed tomography͝ DCIS, ductal carcinoma in situ͝ PET, positron emission tomography͝ PSA, prostate-speciŬc antigen.
How This List Was Created (1–5)
The American Society of Clinical Oncology (ASCO) has had a standing Cost of Cancer Care Task Force since 2007. The role of the Task Force is to assess the
magnitude of rising costs of cancer care and develop strategies to address these challenges. In response to the 2010 New England Journal of Medicine article by
Howard 3rody, MD, “Medicine’s Ethical Desponsibility for Health Care Deform ͼ the Top Five >ist,” a subcommittee of the Cost of Cancer Care Task Force began
work to identify common practices in oncology that were both common as well as lacking suűcient evidence for widespread use. Upon joining the Choosing
Wisely campaign, the members of the subcommittee conducted a literature search to ensure the proposed list of items were supported by available evidence
in oncology; ultimately the proposed Top Five list was approved by the full Task Force. The initial draft list was then presented to the ASCO Clinical Practice
Committee, a group composed of community-based oncologists as well as the presidents of the 48 state/regional oncology societies in the United States.
Advocacy groups were also asked to weigh in to ensure the recommendations would achieve the dual purpose of increasing physician-patient communication
and changing practice patterns. A plurality of more than 200 clinical oncologists reviewed, provided input and supported the list. The Ŭnal Top Five list in oncology
was then presented to, discussed and approved by the Executive Committee of the ASCO Board of Directors and published in the Journal of Clinical Oncology.
ASCO’s disclosure and conůict of interest policies can be found at www.asco.org.
How This List Was Created (6–10)
To guide ASCO in developing this list, suggestions were elicited from current ASCO committee members (approximately 700 individuals); 115 suggestions were
received. After removing duplicates, researching the literature and discussing practice patterns, the Value in Cancer Care Task Force culled the list to 11 items,
which comprised an ASCO Top Five voting slate that was sent back to the membership of all standing committees. Approximately 140 oncologists from its
leadership cadre voted, providing ASCO with an adequate sample size and perspective on what oncologists Ŭnd to be of little value. The list was reviewed and
Ŭnalized by the Value in Cancer Care Task Force and ultimately reviewed and approved by the ASCO Board of Directors and published in the Journal of Clinical
Oncology. ASCO’s disclosure and conůict of interest policies can be found at www.asco.org.
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About the ABIM Foundation
About the American Society of Clinical Oncology
The mission of the ABIM Foundation is to advance
medical professionalism to improve the health
care system. We achieve this by collaborating with
physicians and physician leaders, medical trainees,
health care delivery systems, payers, policymakers,
consumer organizations and patients to foster a shared
understanding of professionalism and how they can
adopt the tenets of professionalism in practice.
The American Society of Clinical
Oncology (ASCO) is the world’s
leading professional organization
representing physicians who care for
people with cancer. With more than
30,000 members, ASCO is committed to improving cancer care through
scientific meetings, educational programs and peer-reviewed journals. ASCO
is supported by its affiliate organization, the Conquer Cancer Foundation,
which funds ground-breaking research and programs that make a tangible
difference in the lives of people with cancer. ASCO’s membership is
comprised of clinical oncologists from all oncology disciplines and
sub-specialties including medical oncology, therapeutic radiology, surgical
oncology, pediatric oncology, gynecologic oncology, urologic oncology,
and hematology; physicians and health care professionals participating in
approved oncology training programs; oncology nurses; and other health
care practitioners with a predominant interest in oncology.
®
To learn more about the ABIM Foundation, visit www.abimfoundation.org.
For more information, please visit www.asco.org.
Π 201
American Society of Clinical Oncology. All rights reserved.
For more information or to see other lists of Five Things Physicians and Patients Should Question, visit www.choosingwisely.org.
MEETING EVALUATION FORM – ASH/ASCO CAC NETWORK MEETING JULY 24 – 25, 2014 – WASHINGTON, DC ASH and ASCO are committed to providing the highest quality for the CAC Network meeting. To assist in meeting that goal, we ask that you please complete the following confidential survey and provide comments or suggestions that you may have. DEMOGRAPHIC INFORMATION: I am (please check all that apply): 







The oncology CAC representative/alternate for my state. The hematology CAC representative/alternate for my state. The president (or another physician representative) of my state oncology society. The executive director/administrator of my state oncology society. A member of ASCO’s Clinical Practice Committee. A member of ASH’s Committee on Practice or ASH’s Subcommittee on Reimbursement. A Medicare contractor medical director. An invited meeting speaker. Evaluation Key 1 2 3 4 5 Strong Agree Agree Neutral Disagree Strongly Disagree Please indicate the degree to which you agree with the statements in each section below by placing a check mark on 1 (strongly AGREE) to 5 (strongly disagree) for each statement. 1. Welcome Reception WELCOME RECEPTION 1 2 3 4 5
The Welcome reception provided an opportunity to network with other CAC representatives, state society representatives, and committee members. The format of the Welcome reception was a valuable addition to the meeting. 2. Group Dinners GROUP DINNERS The group dinners provided the additional opportunity to network with other CAC representatives, state society representatives, committee members, and contractor medical directors. The size of the dinner group was appropriate for networking. I enjoyed the additional opportunity to network with other CAC meeting attendees. 1 2 3 4 5
3. General Meeting GENERAL MEETING I learned new information or obtained a better understanding of a particular issue or topic. The topics discussed are important to my role as a CAC representative, state society representative or committee member. There were adequate opportunities for questions and answers or discussions of topics. The contractor medical director participation in the meeting was helpful in obtaining feedback on important issues. The open microphone session was helpful in understanding CAC‐related issues/topics and fostered communication between CAC representatives and CMDs. The written materials and resources provided in the binder were a helpful supplement to the discussions. The length of the meeting was appropriate. The meeting facility was conducive for the meeting format/structure. 1 2 3 4 5
4. Presentations/Speakers PRESENTATIONS/SPEAKERS I found the presentation on The Attack of The MAC and The RAC by Arthur Lurvey, MD informative. I found the presentation on Clinical Trials: Medicare, MSP, ACA, and Other Issues to Complicate Our Lives by Samuel Silver, MD was educational. The Transition to ICD‐10 presentation by Richard Whitten, MD was helpful. The Payment Reform – What is Really Coming Down the Pike and Open Forum by the panel was beneficial to understanding multiple perspectives in payment reform. The presentation on Molecular Diagnostics and Therapeutics in the Post‐
genomic Era by Jordan Shavit, MD was informative. The presentation on Medicare Coverage of Genomic Testing: Finding Clinical Unity by Louis Jacques, MD was educational. 1 2 3 4 5
5. What aspect(s) of the CAC Network Meeting do you find most valuable? 6. What aspect(s) of the CAC Network Meeting are most in need of improvement? (Please be specific.) 7. What topics or themes would you like to see addressed at future meetings? 8. Overall, how would you rate the CAC Network Meeting? (Please choose one.) a) Excellent b) Good c) Fair d) Poor 9. Is the current format of the CAC Network Meeting effective? (Please circle one): YES or NO  If you circled NO, please provide additional/alternative ways ASH and ASCO can make the meeting more effective. 10. Are there any additional resources ASH and ASCO can provide to assist you with the local coverage process? ** Thank you for your input! Please leave the evaluation form on your table or on the table outside the meeting room. If you are unable to complete the form onsite, please e‐mail the form directly after the meeting to ASH at CACnetworkmeeting@hematology.org ** American Society of Hematology
www.hematology.org
American Society of Clinical Oncology
www.asco.org
AMERICAN SOCIETY OF HEMATOLOGY and
AMERICAN SOCIETY OF CLINICAL ONCOLOGY
2014 CAC Network Meeting
Travel Reimbursement Policy
The ASH-ASCO CAC Network Meeting Travel Reimbursement Policy is provided to travelers regarding reimbursement for
costs incurred in order to participate in the CAC Network Meeting. It is expected that the policy will be adhered to explicitly.
ASCO and ASH will reimburse the following groups for their attendance:
 CAC representatives and alternate representatives for hematology and oncology;
 Members of the ASCO Clinical Practice Committee and ASH Committee on Practice and
Reimbursement Subcommittee;
 Two representatives from the Hematology/ Oncology State Society*
 Medicare Contractor Medical Directors (CMDs) for all A/B MAC jurisdictions.
*Only two representatives from the state society (excluding CAC representatives) will be reimbursed for
attending the ASH/ASCO CAC Network Meeting. State hematology/oncology society presidents and
administrators/executive directors should determine who will attend the meeting. If more than two
individuals from the state society (excluding CAC representatives) attend the meeting, reimbursement
will be the responsibility of the state society or individual.
Coverage begins at the actual start of a trip, whether it is from the traveler’s regular place of
employment, home, or other location, and terminates when the traveler reaches his/her original
destination. Expenses for spouses and/or dependents are personal expenses and are not reimbursable.
Original receipts for all expenditures (including E-ticket passenger receipts, taxis, and parking) of
$25.01 or more must be included with the CAC Network Meeting Expense Reimbursement Form.
Requests for reimbursement must be submitted within thirty (30) days of the meeting for which
reimbursable expenses were incurred. The approved reimbursement will be issued by check.
Air/Train Travel
ASH and ASCO will pay for coach class airline tickets (not business or first class), preferably purchased
through the ASH travel agent Marika Delgado at marika@ewatravel.com or 703-647-7022. Domestic
airline reservations must be made at least 30 days in advance of the meeting. The ASH travel agent will
record the coach roundtrip fare for all destinations 30 days prior to each meeting or activity, and this
amount will be the maximum that will be reimbursed. If a traveler fails to make reservations at least 30
days, the traveler can either (1) make and pay for his/her own reservations and ASH and ASCO will
reimburse the traveler his/her cost up to the amount determined by the ASH travel agent to be the coach
roundtrip fare for that itinerary at 30 days prior to the meeting or activity or (2) make his/her reservations
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American Society of Clinical Oncology
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through the ASH travel agent so that ASH and ASCO are charged directly for the allowable amount and
the traveler charges his/her own credit card for any amount that exceeds the allowable amount.
ASH and ASCO will reimburse the most economical non-refundable coach fares available on a major
airline carrier (American, Delta, Southwest, United, U.S. Airways, etc.). When a significantly less
expensive option is available, reservations made with a particular carrier to benefit the traveler will not
be reimbursed in full; rather, the amount reimbursed will equal the amount of the equivalent ticket on the
most economical carrier.
If an approved traveler wants to bring a guest, they must provide the ASCO travel agent with a personal
credit card for the guest’s travel.
Ground Transportation
ASH and ASCO encourage the use of the most economical ground transportation to and from the airport
or train station and will reimburse such expenses.
Use of a personal or university vehicle will be reimbursed at the mileage rate consistent with IRS rules
and regulations (56 cents per mile as of 1/1/14, including gasoline) plus toll and parking charges.
(ASH and ASCO will reimburse parking charges and mileage as long as this amount is not greater than
the cost of roundtrip taxi or shuttle service.)
If ASH and ASCO approve the use of a rental car, limits will be set and communicated to the traveler by
the appropriate ASH representative. The maximum rates set by ASH and ASCO take into account the
cost of the rental, mileage, gasoline, parking, tolls, and any other expenses related to the use of the rental
in order to attend the meeting.
Hotel
One night hotel stay will be provided for by ASH and ASCO. Additional nights can be reserved but the
attendee will be responsible for the extra stay. (Individuals that would require two nights based on flight
options and/or destinations can contact ASH or ASCO staff.)
The traveler is responsible for promptly submitting the RSVP Survey as requested by the ASH
representative handling hotel room block arrangements. Surveys are due June 6, 2014.
Meals
Meals that are not provided during the meeting will be covered with the following limits including tax
and tip:
Dinner
Lunch
$75.00
$40.00
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Breakfast
American Society of Clinical Oncology
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$25.00
ASCO and ASH provide breakfast and lunch Friday, July 25. Expenses incurred by attendees for either
of these meals will not be reimbursed.
Cancellations and Changes
When a traveler needs to change or cancel an airline reservation, he/she must contact the issuing agent
and notify the appropriate ASH or ASCO representatives immediately. Unless the change or
cancellation is approved by ASH or ASCO, the traveler is responsible for all penalty fees and any other
charges incurred due to such changes or cancellations. If the traveler does not inform the travel agency or
airline of the cancellation prior to the scheduled departure time, and the ticket is thereby rendered
unusable for future travel, then the traveler will be held responsible for the cost of the original ticket.
If a traveler needs to change or cancel a hotel reservation, he or she must contact the appropriate ASH or
ASCO representative at least 72 hours prior to his/her originally scheduled arrival. The traveler is
responsible for reimbursing ASH and ASCO for expenses incurred due to last-minute changes,
cancellations, no-shows, and early departures.
Miscellaneous Expenses
 Baggage service, up to a maximum of one checked bag per flight and similar expenses are
reimbursable.
 Internet service, up to $14 per day is reimbursable while attending the CAC Network Meeting.
 Tips not included with meals or cab fare should be listed separately on the CAC Network Meeting
Expense Reimbursement Form.
 When a trip involves traveling for both the CAC Network Meeting and other purposes, the traveler
must reasonably allocate the costs between CAC Network Meeting and the other activity.
If a traveler has any questions concerning any other reimbursable expenses, he/she should contact the
appropriate ASH or ASCO representative.
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American Society of Hematology American Society of Clinical Oncology www.hematology.org www.asco.org 2014 ASH/ASCO CAC Network Meeting Expense Reimbursement Form Please fill out the information below and attach original receipts. All forms must be submitted by August 25, 2014 Make check payable to: _________________________________________________________ Mail check to: __________________________________________________________________ Meeting Attended: 2014 ASH/ASCO CAC Network Meeting Signature: __________________________________ Date: ___________________________ Itemized Expenses: Date Description of Expense Account (internal use only) Amount _____ _____________________________ _____________ $______ _____ _____________________________ _____________ $______ _____ _____________________________ _____________ $______ _____ _____________________________ _____________ $______ _____ _____________________________ _____________ $______ _____ _____________________________ _____________ $______ For ASH Use Only: Approval: _____________________________________ Date Submitted to Accounting: __________ Please return completed form and original receipts by August 25, 2014 to: Deon Nelson Policy and Practice Coordinator American Society of Hematology 2021 L Street NW, Suite 900, Washington, DC 20036 Phone: 202‐292‐0252 dnelson@hematology.org