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Procedure 218 CLINICAL PRIVILEGE WHITE PAPER Percutaneous lumbar discectomy Background Percutaneous lumbar discectomy (PLD) is a minimally invasive procedure for treating patients who suffer from low back and leg pain due to a herniated vertebral disc. Vertebral discs are the cushioning and connecting materials that lie between the vertebrae of the spine. They protect the vertebrae and give the spine the flexibility to bend and move. When the outer wall of a disc, called the annulus fibrosus, becomes weakened through age or injury, it may tear and allow the soft inner part of the disc, the nucleus pulposus, to bulge out. This is called disc herniation, disc proplapse, or a slipped disc. Once the inner disc material extends out past the regular margin of the outer disc wall, it can press against sensitive nerve tissue in the spine. The bulging disc can compress or even damage the nerve tissue, and this can cause weakness, tingling, or pain in the back area and into one or both legs. Most people find pain relief for herniated discs in conservative treatments such as rest, physical therapy, anti-inflammatory medications, or epidural injections. However, pain does not always respond to these therapies and may require a more aggressive intervention such as open discectomy. This is a surgical procedure to remove part of the damaged disc and thus relieve the pressure on the nerve tissue and alleviate the pain. PLD is a minimally invasive alternative to open discectomy. Physicians perform PLD by inserting a cannula/probe into the disc space with fluoroscopic guidance. Once in place, the herniated disc is scraped, suctioned, or lasered until pressure on the irritated nerve is relieved. PLD is usually performed under local anesthesia and can be done on an outpatient basis. A PLD procedure may be performed on patients with disc herniation who meet the following criteria: Have acute unilateral leg pain localized to a single area, indicating a single spinal nerve affected, or have acute and intractable back pain Show neurologic signs or symptoms such as sensory abnormalities, altered reflexes, a positive straight-leg raising test, or weakness Receive results from magnetic resonance imaging (MRI), computed tomography (CT), or myelography showing herniation of a single lumbar disc Have failed attempts to relieve pain and other signs and symptoms under the supervision of qualified medical personnel through such conservative therapy as bed rest, physical therapy, analgesics, and muscle relaxants Proponents of PLD say its benefits include good to excellent success rates, reduced procedural trauma, low outpatient treatment costs, a rapid rehabilitation process, and low morbidity. Critics of these procedures say during a PLD, the surgeon has no way of seeing the compressed nerve root. Therefore, there is no guarantee that pressure on the nerve will be reduced or eliminated. A supplement to Briefings on Credentialing 781/639-1872 1/04 1

Involved specialties Orthopedic surgeons, neurosurgeons, anesthesiologists, physiatrists, and interventional radiologists who are experienced with discography Positions of societies and academies NASS The North American Spine Society (NASS) publishes the brochure Open Discectomy. In the brochure, the NASS states that open discectomy is the most common surgical treatment for ruptured or herniated discs of the lumbar spine. The procedure may be recommended if diagnostic tests, such as x-rays, MRIs, or a CT scan, verify that the source of the pain is a herniated disc. The NASS further states that spine surgery is currently undergoing a revolution in the way certain surgeries are performed. Discectomies can now be performed arthroscopically through a smaller incision using specialized tools under local anesthesia. In some simpler cases this type of surgery may be recommended. However open discectomy is still considered the gold standard by the spine community for surgical treatment of herniated discs that are causing severe pain or weakness, particularly if the bulge of the disc is extensive, or if pieces of the disc or surrounding bone have actually broken off. Open discectomy allows the surgeon the greatest ability to see and explore the surgical site. The NASS does not publish credentialing or privileging criteria for PLD. 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 satisfy 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 2 A supplement to Briefings on Credentialing 781/639-1872 1/04

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. 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. 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. ABA The American Board of Anesthesiology (ABA) grants certification in the subspecialty of pain management. At the time of certification, the ABA states that each candidate shall be capable of performing independently the entire scope of the subspecialty practice and must meet the following requirements: Be a diplomate of the ABA Hold an unexpired license to practice medicine or osteopathy in at least one state or jurisdiction of the United States or province of Canada that is permanent, unconditional, and unrestricted Have completed 12 months of ACGME-accredited training in acute, chronic, and oncology pain medicine Have satisfied the examination requirement for the subspecialty certification A supplement to Briefings on Credentialing 781/639-1872 1/04 3

Florida Pain Management Associates, Sebastian, FL According to Harold J. Cordner, MD, a board-certified pain management and anesthesiology physician with the Florida Pain Management Associates in Sebastian, FL, PLD includes the following methods for treating patients with contained herniated discs: DISC Nucleoplasty creates a series of channels in the disc and uses plasma energy to remove the discal tissue Laser assisted spinal endoscopy (LASE ) vaporizes the discal tissue Nucleotome uses an automated shaver and continuous irrigation to remove disc tissue The DEKOMPRESSOR probe breaks up discal tissue and sucks it out of the disc Cordner says the only people who should be performing PLD procedures are spine surgeons or interventional pain physicians. They must have expertise in discography, which enables them to place a needle into the disc nucleus, he says. In addition, physicians should have appropriate training in the PLD method they are using so that they can manage any complications that might arise. For competence, Cordner says experienced discographers should be comfortable with the PLD method they are performing when they have done 10 procedures. For maintaining competence, he recommends 10 procedures every two years. Stryker Instruments, Kalamazoo, MI Stryker Instruments, a Kalamazoo, MI based company, markets the DEKOMPRESSOR probe, which is one of the devices used in PLD. The probe is inserted through a tube into the nucleus of the disc and the rotation of the probe tip results in aspiration of the tissue and mechanical evacuation back through the tube. Physicians can see the amount of tissue that has been removed and determine whether the amount is sufficient. The physicians who perform the DEKOMPRESSOR probe procedure are orthopedic surgeons, neurosurgeons, anesthesiologists, and physiatrists, says Eric Gilbert, Stryker s marketing manager. They have experience and training in diagnostic and therapeutic disc access techniques. Board certification in spine surgery or pain management is typical. Stryker offers courses for the probe that includes didactic and cadaver training. But according to Gilbert, most physicians who are experienced with PLD do not require further training. They only have to understand that the candidates for the 4 A supplement to Briefings on Credentialing 781/639-1872 1/04

procedure are those patients who exhibit a contained, lumbar, herniated disc with low back and leg pain and who have failed conservative treatments. Physicians must also learn the contraindications, which include patients with free fragments, severe bony stenosis, or severely degenerative discs. There is a learning curve to the probe procedure, says Gilbert. Physicians quickly learn how much material needs to be pulled out to relieve the pain. He estimates that once they ve done five procedures, physicians can feel fully qualified with the probe technique. CRC draft criteria Minimum threshold criteria for requesting core privileges in PLD 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 or fellowship-training program in orthopedic surgery, neurological surgery, neurology, physical medicine and rehabilitation, anesthesiology, interventional radiology, or pain medicine. Applicants must provide evidence that the training program included fluoroscopy and discography. In addition, applicants should have completed a training course in the PLD method for which privileges are requested. Required previous experience: Applicants must be able to demonstrate that they have performed in the past 12 months at least five procedures in the PLD method for which privileges are requested. Note: A letter of reference should come the director of the applicant s training program that included discography and/or from the director of the applicant s PLD training program. Alternatively, a letter of reference regarding competence should come from a physician experienced in discography 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 per- A supplement to Briefings on Credentialing 781/639-1872 1/04 5

formed at least five procedures in the PLD method for which privileges are requested annually over the reappointment cycle In addition, continuing education related to discography and PLD should be required. For more information For more information regarding this procedure, contact: American Board of Anesthesiology 4101 Lake Boone Trail, Suite 510 Raleigh, NC 27607-7506 Telephone: 919/881-2570 Fax: 919/881-2575 Web site: www.abanes.org 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 Florida Pain Management Associates 13837 US Highway 1 Sebastian, FL 32958 Telephone: 772/388-9998 Fax: 772/388-9742 Web site: www.floridapain.com North American Spine Society 22 Calendar Court, 2nd Floor LaGrange, IL 60525 Telephone: 708/588-8080 Fax: 708/588-1080 Web site: www.spine.org Stryker Instruments 4100 East Milham Avenue Kalamazoo, MI 49001 Telephone: 269/323-7700 Fax: 269/324-5367 Web site: www.inst.strykercorp.com 6 A supplement to Briefings on Credentialing 781/639-1872 1/04

Privilege request form Percutaneous lumbar discectomy In order to be eligible to request clinical privileges in PLD, 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 orthopedic surgery, neurological surgery, neurology, physical medicine and rehabilitation, anesthesiology, interventional radiology, or pain medicine. Applicants must provide evidence that the training program included fluoroscopy and discography. In addition, applicants should have completed a training course in the PLD method for which privileges are requested. Required previous experience: Applicants must be able to demonstrate that they have performed in the past 12 months at least five procedures in the PLD method for which privileges are requested. References: A letter of reference should come the director of the applicant's training program that included discography and/or from the director of the applicant s PLD training program. Alternatively, a letter of reference regarding competence should come from a physician experienced in discography 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 procedures in the PLD method for which privileges are requested annually over the reappointment cycle In addition, continuing education related to discography and PLD 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 781/639-1872 1/04 7

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 Managing Editor: Edwin B. Niemeyer eniemeyer@comcast.net Beverly Pybus President The Beverly Group Georgetown, MA 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 2004 HCPro, Inc., Marblehead, MA 01945. 8 A supplement to Briefings on Credentialing 781/639-1872 1/04