CLINICAL PRIVILEGE WHITE PAPER

Procedure 211 CLINICAL PRIVILEGE WHITE PAPER Orthotripsy Background Orthotripsy is a noninvasive therapy that uses pulses of high-energy shockwaves to treat chronic plantar fasciitis, a condition that causes heel pain. The therapy is designed for adult patients who have had symptoms for a minimum of six months and have tried standard methods of treatment such as medications, injections, physical therapy, or extended rest. Orthotripsy employs the same shockwave technology that has been so effective during the past decade in dissolving kidney stones (lithotripsy) and for many patients with heel pain, the therapy can replace surgery. The shockwaves are created by a spark plug that is enclosed in a soft plastic dome filled with water. During treatment, this dome is placed close against the heel where the patient has the greatest tenderness so that the shockwaves pass through the dome to the heel. The shockwaves seem to encourage new tissue growth, a new blood vessel supply, and healing. Orthotripsy may cause some pain or discomfort, so an anesthetic is commonly given before the procedure. Usually, this is a local anesthetic or a regional anesthetic called a heel block. The treatment usually takes about 30 minutes and is performed as an outpatient procedure. No overnight hospital stay is necessary. Orthotripsy is a registered service mark of HealthTronics, Inc., a Marietta, GA based company that provides the Ossatron brand orthopaedic extracorporeal shock wave system, which is used by orthotripsy physicians. The U.S. Food and Drug Administration (FDA) approved orthotripsy for the treatment of chronic heel pain in October 2000. Involved specialties Orthopedic surgeons and podiatric surgeons Positions of societies and academies AOFAS The American Orthopaedic Foot and Ankle Society (AOFAS) is an organization of more than 1,600 orthopaedic surgeons who have special interest and training in the foot and ankle. Its members are medical doctors and doctors of osteopathy who, after completing medical school, have taken at least five years of additional training to become specialists in the care of diseases and deformities of the foot and the ankle and their surgical treatment. The AOFAS does not publish credentialing or privileging criteria in orthotripsy. A supplement to Briefings on Credentialing 781/639-1872 04/03 1

ACFAS The American College of Foot and Ankle Surgeons (ACFAS) is a professional medical society of more than 5,000 podiatric foot and ankle surgeons. In regard to the treatment of heel pain, the ACFAS publishes the media backgrounder Heel Pain Can Be Cured. In this document, the college states: A relatively new noninvasive technique, extracorporeal shockwave therapy, also is effective for treating severe, chronic heel pain in adults. This new procedure uses a lithotriptor device similar to those used to eliminate kidney stones to generate shock waves aimed at the treatment site. The shockwaves achieve therapeutic results by increasing blood flow to trigger a healing response. This eases inflammation in the heel and relieves chronic pain. During the procedure, a minimum of 1,500 low-intensity shocks are applied directly to the heel. Shockwave therapy is not indicated for anyone under 18 years old, pregnant, or with a history of bleeding problems. Positions of other interested parties ABOS The American Board of Orthopaedic Surgery (ABOS) grants certification in orthopedic surgery. Candidates for certification must meet the following educational and orthopedic requirements. Educational requirements Five years of Accreditation Council for Graduate Medical Education (ACGME) accredited postdoctoral residency, which satisfied the following requirements: Prior to July 1, 2000, four of these years must be served in a program whose curriculum is determined by the director of an accredited orthopedic surgery residency. Three of these years must be served in an accredited orthopedic surgery residency program. One year may be served in an accredited graduate medical program whose educational content is determined or approved by the director of an accredited orthopedic surgery residency program. As of July 1, 2000, one year must be served in an accredited graduate medical educational program whose curriculum fulfills the content requirements for the first postgraduate year and is determined or approved by the director of an accredited orthopedic surgery residency program. An additional four years must be served in an accredited orthopedic surgery residency program whose curriculum is determined by the director of an accredited orthopedic surgery residency program. 2 A supplement to Briefings on Credentialing 781/639-1872 04/03

Orthopedic requirements Orthopedic education must broadly represent the entire field of orthopedic surgery. The minimum distribution of educational experience must include the following: 12 months of adult orthopedics 12 months of fractures/trauma Six months of children s orthopedics Six months of basic science/clinical specialties For the Part II certification examination, the ABOS requires candidates to continuously and actively engage in the practice of operative orthopedic surgery for at least 22 months prior to the examination and to submit all operative cases in which they were the responsible operating surgeons for a six-month consecutive period. AOA The American Osteopathic Association (AOA) grants certification in orthopedic surgery upon recommendation by the American Osteopathic Board of Orthopedic Surgery. To be eligible to receive certification, applicants must meet the following minimum requirements: Graduation from an AOA-accredited college of osteopathic medicine. Licensed to practice in the state or territory where his or her practice is conducted. Membership in good standing of the AOA for a period of at least two years immediately prior to the date of certification. Satisfactory completion of an AOA-approved internship. For training programs commencing after July 1, 1979, completion of four years of AOA-approved training in orthopedic surgery. During the period of formal training, the applicant shall have been the first assistant in the performance of not less than 750 major operative procedures, 500 of which must be of a major orthopedic nature. Documented evidence that the applicant has performed a minimum of 200 major orthopedic procedures upon his or her own responsibility for over a period of at least 12 consecutive months. Practice within the specialty of orthopedics for a period of at least 12 consecutive months subsequent to the required four years of approved training. ABPS The American Board of Podiatric Surgery (ABPS) grants certification in foot surgery and reconstructive rearfoot/ankle surgery (RRA). Foot surgery certification is a prerequisite for RRA certification. A supplement to Briefings on Credentialing 781/639-1872 04/03 3

Candidates who meet the following requirements may be certified in foot surgery: Completion of four years of post-doctor of podiatric medicine (DPM) degree clinical experience Completion of a Council on Podiatric Medical Education (CPME) approved surgical residency Current hospital surgical privileges Submission of a list of 65 foot surgery cases that they have performed in the past seven years Candidates who meet the following requirements may be certified in RRA: Certification in foot surgery Completion of four years of post-dpm degree clinical experience Completion of a CPME-approved surgical residency Current hospital surgical privileges Submission of a list of 30 RRA cases that they have performed in the past seven years Atlanta Medical Center, Atlanta According to G. Lee Cross, MD, an orthopedic surgeon at the Atlanta Medical Center, the physicians who perform orthotripsy are orthopedists and podiatrists who are thoroughly familiar with the surgical techniques that are used to treat plantar fasciitis. In addition, they should have the experience to follow the guidelines about conservative care that require a six-month waiting period before using the procedure. For certification in the orthotripsy procedure, says Cross, physicians must complete a HealthTronics training session. The session includes theoretical training in the physical principle of functioning of shockwaves and teaches the physicians how the orthotripsy machine works. In addition, the physicians observe a minimum of two patient treatments under the supervision of an experienced orthotripsy practitioner and there is hands-on training that utilizes an anatomic model. Once physicians complete their training, there is no formal proctoring of procedures, says Cross. But when the machine is brought to a facility, HealthTronics sends out a company representative who is familiar with what physicians should be doing. The company representative is present for the first few cases and can answer any questions physicians may have. 4 A supplement to Briefings on Credentialing 781/639-1872 04/03

Currently FDA approval of orthotripsy is limited to plantar fasciitis but permission is being sought to use the treatment for tennis elbow and, in the future, for Achilles tendonitis and patella tendonitis. Theoretically, says Cross, the treatment ought to work for almost all of the degenerative tendonopathies. CRC draft criteria Minimum threshold criteria for requesting core privileges in orthotripsy 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, DO, or DPM Minimum formal training: Applicants must have completed an ACGME/AOA-accredited training program in orthopedic surgery or a CPME-accredited training program in podiatric surgery. Applicants must have also completed an orthotripsy course that included shock wave machine training and observed cases. Required previous experience: Applicants must be able to demonstrate that they have performed at least five orthotripsy procedures in the past 12 months. Note: A letter of reference should come from the director of the applicant s orthotripsy training program. Alternatively, a letter of reference regarding competence should come from the chief of orthopedic surgery or podiatric surgery 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 five orthotripsy procedures annually over the reappointment cycle. In addition, continuing education related to orthotripsy should be required. A supplement to Briefings on Credentialing 781/639-1872 04/03 5

For more information For more information regarding this procedure, contact: American Board of Orthopaedic Surgery 400 Silver Cedar Court Chapel Hill, NC 27514 Telephone: 919/929-7103 Fax: 919/942-8988 Web site: www.abos.org American College of Foot and Ankle Surgeons 515 Busse Highway Park Ridge, IL 60068 Telephone: 847/292-2237, 800/421-2237 Fax: 800/382-8270 Web site: www.acfas.org American Orthopaedic Foot and Ankle Society 2517 Eastlake Avenue East, Suite 200 Seattle, WA 98102 Phone: 206/223-1120 Fax: 206/223-1178 Web site: www.aofas.org American Osteopathic Board of Orthopedic Surgery P.O. Box 707 Hershey, PA 17033-0707 Telephone: 877/982-6267 Fax: 717/534-0624 Web site: www.aobos.org American Board of Podiatric Surgery 445 Fillmore Street San Francisco, CA 94117-3404 Telephone: 415/553-7800 Fax: 415/553-7801 Web site: www.abps.org Atlanta Medical Center 303 Parkway Drive Northeast Atlanta, GA 30312-1212 Telephone: 404/265-4000 Fax: 404/265-4419 Web site: www.atlantamedcenter.com 6 A supplement to Briefings on Credentialing 781/639-1872 04/03

HealthTronics Surgical Services, Inc. 1841 West Oak Parkway, Suite A Marietta, GA 30062 Telephone: 800/464-3795, 770/419-0691 Fax: 770/419-9490 Web site: www.healthtronics.com 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 sperney@hcpro.com Executive Editor: Dale Seamans dseamans@hcpro.com 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 Beverly Pybus President The Beverly Group Georgetown, MA Managing Editor: Edwin B. Niemeyer eniemeyer@attbi.com Richard Sheff, MD Vice president of consulting and education 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 2003 HCPro, Inc., Marblehead, MA 01945. A supplement to Briefings on Credentialing 781/639-1872 04/03 7

Privilege request form Orthotripsy In order to be eligible to request clinical privileges in orthotripsy, an applicant must meet the following minimum threshold criteria: Basic education: MD, DO, or DPM Minimum formal training: Applicants must have completed an ACGME/AOA-accredited training program in orthopedic surgery or a CPME-accredited training program in podiatric surgery. Applicants must have also completed an orthotripsy course that included shock wave machine training and observed cases. Required previous experience: Applicants must be able to demonstrate that they have performed at least five orthotripsy procedures in the past 12 months. References: A letter of reference should come from the director of the applicant s orthotripsy training program. Alternatively, a letter of reference regarding competence should come from the chief of orthopedic surgery or podiatric surgery 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 five orthotripsy procedures annually over the reappointment cycle. In addition, continuing education related to orthotripsy 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: 8 A supplement to Briefings on Credentialing 781/639-1872 04/03