CLINICAL PRIVILEGE WHITE PAPER

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1 Procedure 228 CLINICAL PRIVILEGE WHITE PAPER CyberKnife radiosurgery Background The CyberKnife is a nonsurgical radiation delivery system for the treatment of tumors or lesions in the brain, spine, lungs, and elsewhere in the body. The system uses a noninvasive procedure called stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) whereby highly focused beams of radiation are delivered into a tumor from multiple angles to destroy it or stop the growth of the cancerous cells. The CyberKnife system operates as follows: A small linear accelerator that produces radiation is mounted on a robotic arm controlled by image-guided computer technology. The imaging system pinpoints the precise shape and location of the tumor and guides the robotic arm, enabling it to ablate the tumor from multiple positions. The robotic arm compensates for any movement by the patient, providing it with the ability to achieve an extremely high level of accuracy in delivering radiation. Further, the CyberKnife s accuracy limits the amount of radiation to normal or noncancerous tissue surrounding the tumor or lesion. Prior to receiving treatment with CyberKnife radiosurgery, patients undergo a computed tomography, magnetic resonance imaging, magnetic resonance spectroscopy, or positron emission tomography scan. For mapping tumors in the spine, the technology uses skeletal landmarks or tiny implanted markers (e.g., steel screws or gold markers) that are inserted percutaneously into the bone near the tumor, prior to the imaging procedure. The resulting images are reconstructed by the computer workstation and compared to real-time images of the patient in the treatment position. Initially approved by the U.S. Food and Drug Administration (FDA) in 1999 to treat cancer in only the head and neck areas, the FDA granted approval in 2001 to use the CyberKnife for radiosurgical ablation anywhere in the body. Candidates for its use include patients with benign tumors who are not candidates for open surgery or whose tumors are not amenable to surgery. A major advantage of CyberKnife radiosurgery over traditional means of SRS, such as the Gamma Knife, is that it is a frameless system, which does not require the patient to wear an immobilizing metal head frame during treatment. (See Clinical Privilege White Paper Gamma knife radiosurgery, Procedure 83.) Other advantages of CyberKnife radiosurgery over traditional SRS include the following: It has the potential to treat tumors and lesions anywhere in the body A supplement to Briefings on Credentialing 781/ /05 1

2 Treatment takes one to three hours, depending on tumor size No sedation is necessary No incision is made for treatments of the head Only one treatment session may be needed An outpatient setting may be used Little or no recovery time is required There is a lower risk of complications Accuray Incorporated of Sunnyvale, CA, manufactures the CyberKnife system. The company provides initial training for physicians on the use of the CyberKnife, as well as additional education courses for new or current users. Involved specialists Radiation oncologists, neurosurgeons, surgical oncologists, cardiovascular surgeons, thoracic surgeons, orthopedic oncologists, gynecological oncologists, urologists, general surgeons, and medical physicists Positions of academies and societies ACR, ASTRO The American College of Radiology (ACR) and the American Society for Therapeutic Radiology and Oncology (ASTRO) jointly published Practice Guideline for the Performance of Stereotactic Body Radiation Therapy. The guideline states, Stereotactic body radiation therapy is a newly emerging radiotherapy treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body... SBRT can be applied to very localized malignant conditions in the body using minimally invasive stereotactic tumor localization and radiation delivery techniques, but it requires a high degree of precision when directing the ionizing radiation. In addition, it is noted that, The accuracy and precision of SBRT treatment planning and delivery are critical. Therefore, precision should be validated at each treatment session by a reliable quality assurance process. According to the guideline, SBRT requires the coordination of a large and diverse team of professionals including a radiation oncologist, a medical physicist, and a diagnostic radiologist. In the standard, the ACR lists minimum qualification recommendations for the radiation oncologist: Certification in radiology by the American Board of 2 A supplement to Briefings on Credentialing 781/ /05

3 Radiology (ABR) of a physician who confines his or her professional practice to radiation oncology, or certification in radiation oncology or therapeutic radiology by the ABR, the American Osteopathic Board of Radiology, or the Royal College of Physicians and Surgeons of Canada; or Satisfactory completion of radiation oncology residency in an American Council of Graduate Medical Education (ACGME) approved program If residency training did not include SBRT, then specific training in SBRT should be obtained prior to performing any stereotactic procedures. CKS The CyberKnife Society (CKS) is an organization formed to connect users of the CyberKnife and to foster the clinical and academic exchange of information about it. Its primary objectives are as follows: Improve results achieved in the field of radiosurgery by promoting scholarly exchange, with a focus on expanding the role of the CyberKnife Share detailed clinical information pertaining to radiosurgical ablation to promote protocol development Educate patients, families, and the media about radiosurgery Encourage and enhance CyberKnife adoption and radiosurgical techniques in the worldwide medical community and among healthcare providers and patients In addition, the CKS publishes information about domestic and international hospitals and treatment centers that currently perform CyberKnife radiosurgery. Positions of other interested parties ABNS The American Board of Neurological Surgery (ABNS) does not publish specific practice guidelines for the performance of SRS or SBRT procedures. However, the ABNS states that applicants for a general certificate in neurosurgery must be graduates of a medical school that is acceptable to the ABNS. To be eligible for certification, a candidate must have successfully completed neurosurgical residency training in a program that is accredited by the ACGME. The following training in fundamental clinical skills and in neurological surgery is required. A supplement to Briefings on Credentialing 781/ /05 3

4 Twelve months must be devoted to acquiring adequate knowledge in fundamental clinical skills. This year of training is preferably taken prior to beginning neurosurgical residency. It must be done prior to beginning the third year of residency training. This requirement may be satisfied by training for one or more years in an ACGME-accredited general surgery program in the United States. Likewise, the training may be acquired during the course of training in an ACGME-accredited neurosurgical residency program. Such training must include at least six months in surgical disciplines other than neurosurgery. The remaining six months should include other fundamental clinical skills considered appropriate by the neurosurgical training program director, but this portion of the year may not include more than six weeks of neurosurgery. It may include up to three months of neurology. In addition to the required clinical skills, all applicants must fulfill the following training requirements: Each resident must complete a minimum of 60 months of training in the neurological sciences. At least 36 months must be devoted to clinical neurosurgery in a neurosurgical training program or programs accredited by the ACGME with progressive responsibility culminating in 12 months as senior or chief resident. As senior resident, the trainee shall have major or primary responsibility for patient management as deemed appropriate by the program director. The senior resident shall also have administrative responsibilities as designated by the program director. A minimum of three months must be devoted to clinical neurology. This period must be taken as a full-time assigned residency in a neurology residency program accredited by the ACGME. Six months are recommended, but three months are required. Up to three months of this training may be acquired during the 12 months of training in fundamental clinical skills. The remaining months must be devoted to aspects of the basic or clinical neurological sciences, which, at the discretion of the program director, may include neurology, neuropathology, neuroradiology, neurosurgery, research, and/or other disciplines related to the nervous system. Trainees are expected to acquire basic knowledge and skills in each of these disciplines. 4 A supplement to Briefings on Credentialing 781/ /05

5 Sinai Hospital of Baltimore, Department of Radiation Oncology Baltimore, MD According to Mark J. Brenner, MD, FACR, chief of the radiation oncology department and director of the CyberKnife Center at Sinai Hospital of Baltimore, [At Sinai], there are two groups of physicians who use the CyberKnife jointly and in partnership... radiation oncologists and surgeons. We do have help from interventional radiologists in terms of placing the fiducials, but the actual treatment is never performed by a non-surgeon or non-radiation oncologist. Other hospitals do it differently; at some centers, it is viewed purely as a radiation tool, sort of a super IMRT [intensity modulated radiation therapy]. Brenner notes, The reason we have both a radiation oncologist and a surgeon involved in every case is that I see the CyberKnife as neither being a purely radiation oncology tool nor a purely surgical instrument, but a hybrid of the two. Although Sinai has had occasional inquiries from pulmonary doctors and gastroenterologists to perform CyberKnife radiosurgery, he says those specialties are not currently using it there. You should think of credentialing for the use of [CyberKnife] in the same way you would credential for a surgeon, Brenner advises. In addition to neurosurgeons, other surgical specialists performing CyberKnife radiosurgery at Sinai include thoracic surgeons, orthopedic oncologists, surgical oncologists, a gynecological oncologist, and a urologist who recently began training. Brenner notes that Sinai is one of a few hospitals nationwide that trains physicians to perform CyberKnife radiosurgery. We have courses probably quarterly where various surgeons come in and train on it. We had one just for thoracic surgeons, where four or five centers from around the country sent their surgeons to us... It was a two-day, intensive, hands-on training course. We encourage them to bring cases, and they see actual treatment planning with us. It s basically a time to pick our brains. Physicians must have the following in order to be credentialed to perform CyberKnife radiosurgery at Sinai, according to Brenner: Credentialed by the hospital Board-certified in either a surgical specialty or radiation oncology Successful completion of the Accuray-sponsored training course A supplement to Briefings on Credentialing 781/ /05 5

6 Proctored through at least their first three cases For maintenance of privileges, he says surgeons at Sinai must perform at least six CyberKnife radiosurgery procedures annually, while radiation oncologists must perform 10 annually. Even though contouring is part and parcel of the practice of radiation oncology, I believe that there are situations where surgical specialists know the cross-sectional anatomy at least as well, and perhaps better than us. For example, when I am planning treatment for a complex brain tumor, I feel much more comfortable knowing that a neurosurgeon who treats a lot of brain tumors is also looking at it, Brenner says. I honestly believe that this is not purely a radiation therapy modality, nor is it a purely surgical modality. I really look at it as a joint effort. University of California at San Francisco, Departments of Radiation Oncology and Neurological Surgery, San Francisco, CA David A. Larson, PhD, MD, is the director of the CyberKnife radiosurgery program and co-director of the Gamma Knife radiosurgery program at the University of California at San Francisco (UCSF) Medical Center, as well as a professor in the departments of radiation oncology and neurological surgery at UCSF. He is also a board member of the CyberKnife Society. In terms of which specialists should perform CyberKnife radiosurgery, Larson says it depends on how the system is used. If it is being used for single-fraction treatments in the brain (radiosurgery), a radiation oncologist, a neurosurgeon, and a physicist must work together; all three of these specialists must be involved, in keeping with the historical standard of care in the United States for brain radiosurgery, he says. While others believe multiple specialists should work in concert each time the CyberKnife system is used, Larson disagrees. The notion that another physician should assist the radiation oncologist for other than single-fraction brain treatments is driven solely by economic and reimbursement issues rather than by improved quality of care, he says. Larson adds, For the last 50 or 75 years, radiation oncologists have been trained to analyze extent of disease and anatomic site, and then develop a dose plan and fractionation scheme based on their training and working knowledge of tumor and normal tissue radiosensitivity training and knowledge other physicians simply do not have. 6 A supplement to Briefings on Credentialing 781/ /05

7 To begin training on the CyberKnife system at UCSF, Larson notes that, in addition to holding the necessary board certification and hospital privileges, A radiation oncologist, for example, would have to complete the standard vendor training at the Accuray education site. He or she would then have to perform at least five cases at UCSF under the proctorship of a physician who already has credentials for the procedure. According to Larson, both radiation oncologists and medical physicists at UCSF are granted privileges for performing CyberKnife radiosurgery on all sites of the body. The UCSF CyberKnife system is not used for brain radiosurgery. Reprivileging at UCSF is necessary following any 12-month period during which the radiation oncologist or physicist applicant has not directly participated and has not been responsible for at least five cases using the CyberKnife system, Larson explains. Finally, Larson cautions that the often-high reimbursement rates for CyberKnife radiosurgery are motivating more physicians to buy and use the system, regardless of what qualifications and experience they may have. I have seen a number of complications around the country where new radiotherapy technology is used inappropriately. He adds, Sometimes the acquisition of new technology is driven by economics rather than by evidence-based medicine or improved quality of care, and that is most unfortunate. CRC draft criteria Minimum threshold criteria for requesting core privileges in CyberKnife radiosurgery The following draft criteria are intended to serve solely as a starting point for the development of an institution s policy regarding this procedure. Basic education: MD or DO Minimum formal training: Applicants must have completed an ACGME/American Osteopathic Association (AOA) accredited residency training program in radiation oncology, surgical oncology, neurosurgery, or other appropriate surgical or oncological specialty. If this training did not include radiosurgery, then specific training in radiosurgery should be obtained prior to performing any CyberKnife radiosurgery procedures. Applicants must also have completed an approved training program in the use of the CyberKnife system, taught by an Accuray representative. Required previous experience: Applicants must be able to A supplement to Briefings on Credentialing 781/ /05 7

8 demonstrate that they have performed at least 10 CyberKnife radiosurgery procedures in the past 12 months. In addition, proctoring by an experienced CyberKnife practitioner should be required for at least the first three cases. References A letter of reference should come from the director of the applicant s CyberKnife radiosurgery training program. Alternatively, a letter of reference regarding competence should come from the chief of surgery or chief of radiation oncology at the institution where the applicant most recently practiced. Reappointment Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have performed at least 10 CyberKnife radiosurgery procedures annually over the reappointment cycle. In addition, continuing education related to the CyberKnife system and SBRT procedures should be required. For more information For more information about this procedure, contact: Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, CA Telephone: 408/ Fax: 408/ Web site: American Board of Neurological Surgery 6550 Fannin Street, Suite 2139 Houston, TX Telephone: 713/ Fax: 713/ Web site: 8 A supplement to Briefings on Credentialing 781/ /05

9 American College of Radiology 1891 Preston White Drive Reston, VA Telephone: 703/ ; Toll free: 800/ Fax: 703/ Web site: American Society for Therapeutic Radiology and Oncology Fair Lakes Circle, Suite 375 Fairfax, VA Telephone: 703/ ; Toll free: 800/ Fax: 703/ Web site: CyberKnife Society 1310 Chesapeake Terrace Sunnyvale, CA Telephone: 408/ Fax: 408/ Web site: Sinai Hospital of Baltimore Department of Radiation Oncology 2401 West Belvedere Avenue Baltimore, MD Telephone: 410/ Fax: 410/ Web site: University of California at San Francisco Department of Radiation Oncology San Francisco, CA Telephone: 415/ Fax: 415/ Web site: A supplement to Briefings on Credentialing 781/ /05 9

10 10 A supplement to Briefings on Credentialing 781/ /05

11 Privilege request form CyberKnife radiosurgery To be eligible to request clinical privileges in CyberKnife radiosurgery, an applicant must meet the following minimum threshold criteria: Basic education: MD or DO Minimum formal training: Applicants must have completed an ACGME/AOA-accredited residency or fellowship training program in radiation oncology, surgical oncology, neurosurgery, or other appropriate surgical or oncological specialty. If this training did not include radiosurgery, then specific training in radiosurgery should be obtained prior to performing any CyberKnife radiosurgery procedures. Applicants must also have completed an approved training program in the use of the CyberKnife system, taught by an Accuray representative. Required previous experience: Applicants must be able to demonstrate that they have performed at least 10 CyberKnife radiosurgery procedures in the past 12 months. In addition, proctoring by an experienced CyberKnife practitioner should be required for at least the first three cases. References: A letter of reference should come from the director of the applicant s CyberKnife radiosurgery training program. Alternatively, a letter of reference regarding competence should come from the chief of surgery or chief of radiation oncology at the institution where the applicant most recently practiced. Reappointment: Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have performed at least 10 CyberKnife radiosurgery procedures annually over the reappointment cycle. In addition, continuing education related to the CyberKnife system and SBRT procedures should be required. I understand that by making this request I am bound by the applicable bylaws or policies of the hospital, and hereby stipulate that I meet the minimum threshold criteria for this request. Physician s signature: Typed or printed name: Date: A supplement to Briefings on Credentialing 781/ /05 11

12 Clinical Privilege White Papers Advisory Board James F. Callahan, DPA Executive vice president and CEO American Society of Addiction Medicine Chevy Chase, MD Sharon Fujikawa, PhD Clinical professor, Dept. of Neurology University of California, Irvine Medical Center Orange, CA John N. Kabalin, MD, FACS Urologist/Laser surgeon Scottsbluff Urology Associates Scottsbluff, NE Publisher/Vice President: Suzanne Perney Group Publisher: Kathryn Levesque John E. Krettek Jr., MD, PhD Neurological surgeon Vice president for medical affairs Missouri Baptist Medical Center St. Louis, MO Michael R. Milner, MMS, PA-C Senior physician assistant consultant Phoenix Indian Medical Center Phoenix, AZ Senior Managing Editor: Edwin B. Niemeyer Beverly Pybus Senior consultant The Greeley Company Marblehead, MA Richard Sheff, MD Chair and Executive Director The Greeley Company, a division of HCPro, Inc. Marblehead, MA The information contained in this document is general. It has been designed and is intended for use by hospitals and their credentials committees in developing their own local approaches and policies for various credentialing issues. This information, including the materials, opinions, and draft criteria set forth herein, should not be adopted for use without careful consideration, discussion, additional research by physicians and counsel in local settings, and adaptation to local needs. The Credentialing Resource Center does not provide legal or clinical advice; for such advice, the counsel of competent individuals in these fields must be obtained. Reproduction in any form outside the recipient s institution is forbidden without prior written permission. Copyright 2005 HCPro, Inc., Marblehead, MA A supplement to Briefings on Credentialing 781/ /05