VERTEBRAL COMPRESSION FRACTURE AND KIENBOCK S DISEASE TREATMENTS

Transcription

1 TREATMENTS Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. Description: Kyphoplasty: A percutaneous fluoroscopically guided or direct vision procedure where a balloon with a bone tamp is inserted into the vertebral body or other body area (e.g., wrist) and inflated to push the collapsed bone back into place. The cavity is then filled with bone cement to restore height and prevent further collapse. This procedure may also be referred to as balloon kyphoplasty. Radiofrequency Kyphoplasty: Radiofrequency kyphoplasty is a modification of balloon kyphoplasty for vertebral fractures. In this procedure, an ultrahigh viscosity cement is injected into the fractured vertebral body and radiofrequency is used to achieve the desired consistency of the cement. The ultrahigh viscosity cement is designed to restore height and alignment to the fractured vertebra along with stabilizing the fracture. Optiplasty: A variant of kyphoplasty, also referred to as biologic vertebral reconstruction, where a drill is used to create a cavity in the vertebral body and a porous mesh sack (OptiMesh ) is inserted into the cavity and then filled with bone graft material. OptiMesh does not provide structural support and is contraindicated for individuals with instability (e.g., resected or collapsed vertebral bodies or fracture of the anterior column). Optiplasty has been investigated as a technique to restore vertebral body integrity. O docx Page 1 of 8

2 Description: (cont.) Vertebroplasty: A percutaneous fluoroscopically guided procedure in which bone cement is injected into a collapsed or weakened vertebral body to provide bone strengthening and pain relief. Vertebroplasty may also be used as a technique to stabilize and limit blood loss during surgical resection of vertebral hemangiomas. Sacroplasty: A variant of vertebroplasty, where bone cement is injected into the fractured vertebral body to provide stability and pain relief. Sacroplasty has been investigated as a treatment for sacral insufficiency fractures. Kienbock's Disease: A condition of the wrist sometimes caused by trauma. Criteria: Kyphoplasty: Kyphoplasty is considered medically necessary for an individual with continual incapacitating pain who has failed a trial of greater than 4 weeks of conservative care* with documentation of ANY of the following: 1. Osteoporotic vertebral compression fracture(s) 2. Trauma-related vertebral compression fracture(s) 3. Steroid-induced vertebral compression fracture(s) * A trial of conservative care includes, but is not limited to, bedrest, immobilization/bracing devices, non-narcotic analgesic medications, narcotic analgesic medications and physical therapy. A trial of conservative care may be contraindicated. Kyphoplasty is considered medically necessary for an individual with osteolytic vertebral body fracture with documentation of ALL of the following: 1. Individual has continual incapacitating pain 2. No evidence of vertebral body destruction 3. Vertebral body fracture is related to multiple myeloma or metastatic malignancies 4. Chemotherapy and radiation therapy have failed to relieve the pain 5. No involvement of the major part of the cortical bone O docx Page 2 of 8

3 Criteria: (cont.) Kyphoplasty: (cont.) Kyphoplasty for all other indications not previously listed is considered experimental or investigational based upon: 1. Insufficient evidence to support improvement of the net health outcome, and 2. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. These indications include, but are not limited to: Acute vertebral fractures Kienbock s disease Optiplasty: Optiplasty for all indications is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 4. Insufficient evidence to support improvement outside the investigational setting. Sacroplasty: Sacroplasty for all indications is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 4. Insufficient evidence to support improvement outside the investigational setting. O docx Page 3 of 8

4 Criteria: (cont.) Vertebroplasty: Vertebroplasty is considered medically necessary for an individual with continual incapacitating pain who has failed a trial of greater than 4 weeks of conservative care* with documentation of ANY of the following: 1. Osteoporotic vertebral compression fracture(s) 2. Trauma-related vertebral compression fracture(s) 3. Steroid-induced vertebral compression fracture(s) * A trial of conservative care includes, but is not limited to, bedrest, immobilization/bracing devices, non-narcotic analgesic medications, narcotic analgesic medications and physical therapy. A trial of conservative care may be contraindicated. Vertebroplasty is considered medically necessary for an individual with osteolytic vertebral body fracture with documentation of ALL of the following: 1. Individual has continual incapacitating pain 2. No evidence of vertebral body destruction 3. Vertebral body fracture is related to multiple myeloma or metastatic malignancies 4. Chemotherapy and radiation therapy have failed to relieve the pain 5. No involvement of the major part of the cortical bone Vertebroplasty is considered medically necessary for vertebral hemangioma with documentation of ALL of the following: 1. Procedure is intended to limit the extent of surgical resection 2. Procedure is intended as an adjunct to decrease associated surgical blood loss Vertebroplasty for all other indications not previously listed is considered experimental or investigational based upon: 1. Insufficient evidence to support improvement of the net health outcome, and 2. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. These indications include, but are not limited to: Acute vertebral fractures O docx Page 4 of 8

5 Resources: BCBS Association Medical Policy Reference Manual. Percutaneous Vertebroplasty and Sacroplasty. Re-issue date 03/09/2012, issue date 04/30/ BCBS Association Medical Policy Reference Manual. Percutaneous Kyphoplasty. Reissue date 03/09/2012, issue date 12/18/ Afzal S, Dhar S, Vasavada NB, Akbar S. Percutaneous vertebroplasty for osteoporotic fractures. Pain Physician Jul 2007;10(4): American Association of Neurological Surgeons, Khoo LT, Cosar M. The Results of Minimal Invasive Optimesh Graft Technique for Stand-Alone Lumbar Interbody Fusion in Spondylolisthesis. 03/15/ American Association of Neurological Surgeons, Stechison II MT. Biologic Vertebral Augmentation in Thoracic and Lumbar Fractures. 04/24/ Banerjee S, Baerlocher MO, Asch MR. Back stab: percutaneous vertebroplasty for severe back pain. Can Fam Physician Jul 2007;53(7): Beattie K, Papaioannou A, Boulos P, Adachi JD. Kyphoplasty and Vertebroplasty for the Treatment of Osteoporotic Vertebral Compression Fractures. Geriatrics & Aging. 02/2003;6(2): Bono CM, Kauffman CP, Garfin SR. Kyphoplasty. Seminars in Spine Surgery. 12/2002;14(4): California Technology Assessment Forum. Percutaneous Kyphoplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. Blue Shield of California Foundation. 10/19/ California Technology Assessment Forum. Percutaneous Vertebroplasty for Vertebral Fractures Caused by Osteoporosis or Malignancy. Blue Shield of California Foundation. 10/19/ California Technology Assessment Forum. Balloon Kyphoplasty as a Treatment for Vertebral Compression Fractures. Blue Shield of California Foundation. 06/17/ California Technology Assessment Forum. Vertebroplasty as a Treatment of Osteoporotic Vertebral Fractures (an update based on the VERTOS II trial). Blue Shield of California Foundation. 02/16/ O docx Page 5 of 8

6 Resources: (cont.) 13. Centers for Medicare & Medicaid Services. LCD for Vertebroplasty, Kyphoplasty; Percutaneous (L24383). 04/01/ Chen W, Wang J, Pan J, Zhang Q, Shao X, Zhang Y. Primary results of Kienbock's disease treated using balloon kyphoplasty system. Arch Orthop Trauma Surg. May 2012;132(5): Chiu JC, Maziad AM. Post-traumatic Vertebral Compression Fracture Treated with Minimally Invasive Biologic Vertebral Augmentation for Reconstruction. Surg Technol Int. Dec ;XXI: Clinical Trials Web Site. Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty with Quality of Life Assessment. accessed 05/19/ Coen D. Kyphoplasty as a treatment for vertebral compression fractures as a result of multiple myeloma. Clin J Oncol Nurs Mar-Apr 2003;7(2): Cortet B, Roches E, Logier R, et al. Evaluation of spinal curvatures after a recent osteoporotic vertebral fracture. Joint Bone Spine Mar 2002;69(2): De Negri P, Tirri T, Paternoster G, Modano P. Treatment of painful osteoporotic or traumatic vertebral compression fractures by percutaneous vertebral augmentation procedures: a nonrandomized comparison between vertebroplasty and kyphoplasty. Clin J Pain Jun 2007;23(5): External Consultant Review. Orthopedic Surgery. 06/01/ External Consultant Review. Orthopedic Surgery. 09/12/ External Consultant Review. Orthopedic Surgery. 06/10/ Fourney DR, Schomer DF, Nader R, et al. Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg Jan 2003;98(1 Suppl): Frey ME, Depalma MJ, Cifu DX, Bhagia SM, Carne W, Daitch JS. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J Mar-Apr 2008;8(2): Frey ME, DePalma MJ, Cifu DX, Bhagia SM, Daitch JS. Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures: a prospective, multicenter trial. Spine Jul ;32(15): O docx Page 6 of 8

7 Resources: (cont.) 26. Garfin SR, Buckley RA, Ledlie J. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine Sep ;31(19): Gill JB, Kuper M, Chin PC, Zhang Y, Schutt RJ. Comparing pain reduction following kyphoplasty and vertebroplasty for osteoporotic vertebral compression fractures. Pain Physician Jul 2007;10(4): Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies. Spine Aug ;31(17): Hur W, Choi SS, Lee M, Lee DK, Lee JJ, Kim K. Spontaneous Vertebral Reduction during the Procedure of Kyphoplasty in a Patient with Kummell's Disease. Korean J Pain. Dec 2011;24(4): InterQual Care Planning, Procedures Adult. Vertebroplasty. 31. Joint Section on Disorders of the Spine and Peripheral Nerves American Association of Neurological Surgery and Congress of Neurological Surgery. Percutaneous Vertebroplasty Standards of Practice. 04/07/ Kruger A, Hierholzer J, Bergmann M, Oberkircher L, Ruchholtz S. [Current status of vertebroplasty and kyphoplasty in Germany : An analysis of surgical disciplines.]. Unfallchirurg. May Ledlie JT, Renfro M. Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg Jan 2003;98(1 Suppl): Lin CC, Chen IH, Yu TC, Chen A, Yen PS. New symptomatic compression fracture after percutaneous vertebroplasty at the thoracolumbar junction. AJNR Am J Neuroradiol Jun- Jul 2007;28(6): Linville 2nd DA. Vertebroplasty and kyphoplasty. South Med J Jun 2002;95(6): Pflugmacher R, Beth P, Schroeder RJ, Schaser KD, Melcher I. Balloon kyphoplasty for the treatment of pathological fractures in the thoracic and lumbar spine caused by metastasis: oneyear follow-up. Acta Radiol Feb 2007;48(1): Pflugmacher R, Kandziora F, Schroeder RJ, Melcher I, Haas NP, Klostermann CK. Percutaneous balloon kyphoplasty in the treatment of pathological vertebral body fracture and deformity in multiple myeloma: a one-year follow-up. Acta Radiol May 2006;47(4): O docx Page 7 of 8

8 Resources: (cont.) 38. Phillips FM, Todd Wetzel F, Lieberman I, Campbell-Hupp M. An in vivo comparison of the potential for extravertebral cement leak after vertebroplasty and kyphoplasty. Spine Oct ;27(19): ; discussion Ploeg WT, Veldhuizen AG, The B, Sietsma MS. Percutaneous vertebroplasty as a treatment for osteoporotic vertebral compression fractures: a systematic review. Eur Spine J Dec 2006;15(12): Stoffel M, Wolf I, Ringel F, Stuer C, Urbach H, Meyer B. Treatment of painful osteoporotic compression and burst fractures using kyphoplasty: a prospective observational design. J Neurosurg Spine Apr 2007;6(4): Strub WM, Hoffmann M, Ernst RJ, Bulas RV. Sacroplasty by CT and fluoroscopic guidance: is the procedure right for your patient? AJNR Am J Neuroradiol Jan 2007;28(1): Taylor RS, Taylor RJ, Fritzell P. Balloon kyphoplasty and vertebroplasty for vertebral compression fractures: a comparative systematic review of efficacy and safety. Spine Nov ;31(23): TEC Clearinghouse News. Optiplasty - A Variation in Vertebral Fracture Treatment. 09/30/ Truumees E. The roles of vertebroplasty and kyphoplasty as parts of a treatment strategy for osteoporotic vertebral compression fractures. Current Opinion in Orthopaedics. 2002: Whitlow CT, Mussat-Whitlow BJ, Mattern CW, Baker MD, Morris PP. Sacroplasty versus vertebroplasty: comparable clinical outcomes for the treatment of fracture-related pain. AJNR Am J Neuroradiol Aug 2007;28(7): Zhang Y, Yang H, Liu Y, et al. [Percutaneous kyphoplasty in hyperextension position for treatment of middle and late period Kummell disease]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. Apr 2012;26(4): O docx Page 8 of 8