1. Working Together: How to Build a Radiosurgical Center and Partnership Sandra Vermeulen, M.D. Seattle Cyberknife Center at Swedish Cancer Institute Seattle, WA

2. Swedish Cancer Institute: Background Radiation oncology providers for 7 facilities in Puget Sound area: Radiation oncology providers for 7 facilities in Puget Sound area: Swedish Hospital at First HillSwedish Hospital at First Hill Swedish Providence CampusSwedish Providence Campus Seattle Prostate InstituteSeattle Prostate Institute Northwest HospitalNorthwest Hospital Valley Medical CenterValley Medical Center Highline HospitalHighline Hospital Stevens HospitalStevens Hospital 15 radiation oncologists treat 220 external beams patients per day, and perform 600+ brachytherapy and 300+ Gamma Knife procedures per year 15 radiation oncologists treat 220 external beams patients per day, and perform 600+ brachytherapy and 300+ Gamma Knife procedures per year

3. Seattle Cyberknife: Driving Force Private Medical Investment Group: Private Medical Investment Group: Assessed a need in Seattle areaAssessed a need in Seattle area Approached regional hospitals and medical groupsApproached regional hospitals and medical groups Intent to partner with prominent neurosurgical and radiation oncology groups Intent to partner with prominent neurosurgical and radiation oncology groups Swedish Hospital logical partner choice:Swedish Hospital logical partner choice: Largest oncology provider in the region Largest oncology provider in the region Large neurosurgical and radiation oncology services Large neurosurgical and radiation oncology services

4. Swedish Radiation Oncology Physician Group: Decision Process for Participation Stereotactic Radiosurgery: is there a need? Stereotactic Radiosurgery: is there a need? Do clinical studies support hypofractionated, stereotactic treatment?Do clinical studies support hypofractionated, stereotactic treatment? Are there sufficient patients to justify the device?Are there sufficient patients to justify the device? IGRT Platforms: is the Cyberknife the best? IGRT Platforms: is the Cyberknife the best? How about Trilogy, Synergy, Tomotherapy?How about Trilogy, Synergy, Tomotherapy? Financial Analysis: does it make sense? Financial Analysis: does it make sense? What physician resources are required, and what reimbursement will be realized?What physician resources are required, and what reimbursement will be realized?

5. Stereotactic Radiosurgery: Is there a need? GammaKnife experience proved efficacy of cranial SRS; frameless systems allow fractionation GammaKnife experience proved efficacy of cranial SRS; frameless systems allow fractionation For extra-cranial SRS, literature review showed clinical efficacy in: For extra-cranial SRS, literature review showed clinical efficacy in: SpineSpine Head and neckHead and neck LungLung Liver & pancreasLiver & pancreas Previously radiated sitesPreviously radiated sites Population of the region, and size of Swedish network sufficiently large to justify SRS unit Population of the region, and size of Swedish network sufficiently large to justify SRS unit

6. The World of Image-guided RT: Is the Cyberknife the best? The World of Image-guided RT: Is the Cyberknife the best? Few people really understand the differences in platforms Few people really understand the differences in platforms Slow dose-rate limits throughputSlow dose-rate limits throughput Swedish Hospital had Elekta Synergy S Unit, and will be clinical/research development siteSwedish Hospital had Elekta Synergy S Unit, and will be clinical/research development site Advantages of Cyberknife over other platforms: Advantages of Cyberknife over other platforms: Cyberknife only image-guided platform with real-time target correction capabilityCyberknife only image-guided platform with real-time target correction capability Only device with model to track respiratory motionOnly device with model to track respiratory motion Greater degree of targeting freedom theoretically yields superior dose deliveryGreater degree of targeting freedom theoretically yields superior dose delivery

7. Cyberknife

8. Financial Analysis: Does it make sense for radiation oncology group? What did radiation oncologist using CK say? What did radiation oncologist using CK say? Amazing technology, excellent clinical outcomesAmazing technology, excellent clinical outcomes Enormous amount of workEnormous amount of work Reimbursement was awfulReimbursement was awful “Just say no”, unless additional compensation given“Just say no”, unless additional compensation given Financial per formas: hospital versus professional Financial per formas: hospital versus professional

9. Projected Hospital Revenue from CK Center A successful CK center breaks even in year two, and can bring in 1-2 million/yr in 4 - 5 years

10. Professional Radiation Oncology Revenue from Cyberknife SRS Ratio of revenue for equal work ext beam : CK 3 : 1 (!) (!)

11. Radiation Oncologists’ Reimbursement Why so poor? Why so poor? SRS management codes (77427, 77431) not yet reimbursed for extra-cranial treatmentsSRS management codes (77427, 77431) not yet reimbursed for extra-cranial treatments Radiation oncology billing historically weighted heavily towards weekly management feesRadiation oncology billing historically weighted heavily towards weekly management fees Treatment planning codes undervalued relative to work effort requiredTreatment planning codes undervalued relative to work effort required Treatment planning effort can be shifted to surgeon (CPT code 61793), increasing patient loadTreatment planning effort can be shifted to surgeon (CPT code 61793), increasing patient load Shift in mindset: must be comfortable having other disciplines participate in contouring and planning Shift in mindset: must be comfortable having other disciplines participate in contouring and planning

12. Planning the Treatment Center Stand-alone center? Association with existing radiation oncology facility allows Stand-alone center? Association with existing radiation oncology facility allows Efficiencies in office spaceEfficiencies in office space Efficiencies in staffingEfficiencies in staffing Physical space: hire architects experienced in medical construction Physical space: hire architects experienced in medical construction Corridors need to accommodate gurneys?Corridors need to accommodate gurneys? Bathrooms, dirty & clean utilities, etc…Bathrooms, dirty & clean utilities, etc…

13. Assigning Staff: Cyberknife is Complex, New Technology Uncertainty at every step:Uncertainty at every step: Indication for treatment are evolving Indication for treatment are evolving Treatment protocols are not well defined Treatment protocols are not well defined Every patient requires justification with insurance company Every patient requires justification with insurance company Multidisciplinary treatment requires education and participation of numerous MDs and staff Multidisciplinary treatment requires education and participation of numerous MDs and staff Numerous steps require coordination Numerous steps require coordination Fiducial placements – require IR – currently their work is not reimbursed Fiducial placements – require IR – currently their work is not reimbursed Treatment planning processes (CT requirements, MR fusion) are unique, require forethought Treatment planning processes (CT requirements, MR fusion) are unique, require forethought

14. Staffing Staffing Hire motivated, smart staff, preferably with experience in radiation oncology Hire motivated, smart staff, preferably with experience in radiation oncology Assign a manager to oversee the projectAssign a manager to oversee the project Physicists are expensive and hard to findPhysicists are expensive and hard to find An organized, efficient RN or coordinator, is needed that can multi- task wellAn organized, efficient RN or coordinator, is needed that can multi- task well Assign a technologically savvy, high- performing therapistAssign a technologically savvy, high- performing therapist

15. Plan in Advance! Have manager and staff members in each domain trained through Accuray Have manager and staff members in each domain trained through Accuray Have staff members (MD, physicist, RN, therapist) proactively plan office requirements Have staff members (MD, physicist, RN, therapist) proactively plan office requirements Office suppliesOffice supplies Examining room equipment and suppliesExamining room equipment and supplies Patient chartsPatient charts Treatment equipmentTreatment equipment Physics QA requirementsPhysics QA requirements

16. Educate Ancillary Departments Develop written CT and MR imaging protocols: Develop written CT and MR imaging protocols: For CT: slice thickness, pitch, # images, center, patient position, contrast agentsFor CT: slice thickness, pitch, # images, center, patient position, contrast agents For MRI: location and size of matrix, scanning interval, sequence, contrast agentsFor MRI: location and size of matrix, scanning interval, sequence, contrast agents Interventional radiology crucial for fiducial placement Interventional radiology crucial for fiducial placement Meet with MDs, radiology office manager to explain programMeet with MDs, radiology office manager to explain program Reimbursement is a problem – but other diagnostic studies can off –set their timeReimbursement is a problem – but other diagnostic studies can off –set their time Explain detailed requirements of fiducial placementExplain detailed requirements of fiducial placement

17. Insurance Regional Medicare intermediary initially not paying professional fees for extra- cranial SRS Regional Medicare intermediary initially not paying professional fees for extra- cranial SRS Will this be treatment be reimbursed? Will this be treatment be reimbursed? Meet with medical director, present literatureMeet with medical director, present literature Other carriers may be reluctant to pay: Other carriers may be reluctant to pay: Meet with medical directors in advanceMeet with medical directors in advance Be prepared to justify treatment with literatureBe prepared to justify treatment with literature Write letters of medical necessityWrite letters of medical necessity

18. Educate Your Referral Base Market to physicians: Market to physicians: Relationships with referring doctorsRelationships with referring doctors Presentations at tumor boards, grand rounds, etc…Presentations at tumor boards, grand rounds, etc… At local hospitals and regional facilities At local hospitals and regional facilities Open houseOpen house Direct informational mailingsDirect informational mailings Market to community: Market to community: Local media – papers, televisionLocal media – papers, television WebsiteWebsite

19. Clinical Considerations Extra-cranial SRS is new and few have experiencing training Extra-cranial SRS is new and few have experiencing training Well-established treatment guidelines don’t exist Well-established treatment guidelines don’t exist Follow-up and complication data on hypofractionated body SRS is limited Follow-up and complication data on hypofractionated body SRS is limited

20. To Determine Clinical Guidelines Attend the Cyberknife Society meetings Attend the Cyberknife Society meetings Read the literature – CK Society has a good reference list Read the literature – CK Society has a good reference list Review radiobiology Review radiobiology Talk with other CK Society members Talk with other CK Society members Amount of information is overwhelming, so assign disease sites to different doctors: Amount of information is overwhelming, so assign disease sites to different doctors: Agree on guidelines for each disease site/stageAgree on guidelines for each disease site/stage If there is no literature on a treatment approach, submit formal protocol to your hospital IRBIf there is no literature on a treatment approach, submit formal protocol to your hospital IRB Consider gathering data on dosing, toxicity, and clinical outcomes to guide future treatments Consider gathering data on dosing, toxicity, and clinical outcomes to guide future treatments

21. Summary Realize enormous work effort required to start center and treat CK patients Realize enormous work effort required to start center and treat CK patients MDs should evaluate in advance the financial implications of participating MDs should evaluate in advance the financial implications of participating Hire best available staff, preferably with radiation oncology experience Hire best available staff, preferably with radiation oncology experience Get trained and organized in advance Get trained and organized in advance Pro-active involvement & education of: Pro-active involvement & education of: Insurance companiesInsurance companies Ancillary services (intervention radiology)Ancillary services (intervention radiology) Uncharted clinical waters: physicians do your homework, and cautiously write protocols/guidelines. Uncharted clinical waters: physicians do your homework, and cautiously write protocols/guidelines.

22. Conclusion Cyberknife is a marvelous technology, that offers non-invasive treatment instead of surgery, or pain relief instead of morphine, or hope when before there was none.