Medical Policy Extracorporeal Shock Wave Therapy (ESWT) for Refractory Tendonopathies

Effective Date: October, 2002; Revised [10/06; 10/08; 10/10]

Subject: Extracorporeal Shock Wave Therapy (ESWT) for Refractory Tendonopathies Overview: Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment proposed to treat refractory tendonopathies such as plantar fasciitis and lateral epicondylitis (i.e., tennis elbow) and introduced as an alternative to surgery for patients with that have not responded to other conservative therapies. Policy and Coverage Criteria:
Extracorporeal Shock Wave Therapy (ESWT) is NOT a covered service due to insufficient evidence of its safety and efficacy. It is considered experimental/investigational and unproven.

Exclusions: N/A Supporting Information:

1. Technology Assessment: Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of low- or high-energy shock waves via a device to a specific site within the body. These pressure waves travel through fluid and soft tissue; their effects occur at sites where there is a change in impedance, such as the bone/soft-tissue interface. Low-energy shock waves are applied in a series of treatments and do not typically cause any pain. High-energy shock wave treatments are generally given in one session and usually require some type of anesthesia. 2. Literature review: Plantar Fasciitis: There is limited and conflicting evidence in peer-reviewed literature supporting the use of ESWT for plantar fasciitis. Thomson et al. (2005) conducted a review of randomized controlled trials to determine the effectiveness of ESWT for plantar heel pain. Based on their inclusion criteria, researchers evaluated 6 randomized control trials with a total of 897 patients. The results of their meta-analysis were statistically significant in favor of ESWT for treatment of plantar heel pain but the effect size was very small. A sensitivity analysis including only high quality trials did not detect a statistically significant event. Kudo et al. (2006) and Malay et al. (2006) also reported statistically significant improvements in pain as part of two separate randomized, double-blind, placebo controlled studies evaluating the safety and efficacy of ESWT. Another double-blind, randomized, placebo-controlled study by Buchbinder et al. (2002) found no significant difference in pain improvement between patients treated with ESWT and those treated with placebo at 6 and 12 weeks of follow up. A 2009 Technology Assessment from the California Technology Assessment Forum (CTAF) found ESWT for plantar fasciitis unresponsive to conservative therapy did not meet CTAF criteria. After reviewing evidence, CTAF concluded: Patients with PF tend to improve over extended periods of time, even patients who have failed conservative therapy for months. Therefore, the uncontrolled studies of ESWT, while promising, may represent mainly the natural history of the disorders abetted by a strong placebo effect. Studies with pain as the primary outcome commonly are subject to large placebo effects. Indeed, in the non-blinded RCTs of ESWT, the placebo group usually reported minimal improvements, while the placebo group in the well blinded studies reported 30% to 50% improvements in pain scores. The CTAF also noted there was significant variability in the quality of the randomized trials and in the interventions reported in the literature.

Additionally, a number of systematic reviews also concluded ESWT is not a proven treatment for plantar fasciitis (Buchbinder, 2004; Burton and Overend, 2005; Boddeker et al., 2001). Lateral epicondylitis: Buchbinder et al. conducted a 2006 review of randomized controlled trials to evaluate the efficacy and safety of ESWT for lateral elbow pain. They reviewed nine placebo-controlled trials (1006 patients) and one trial of ESWT versus steroid injection (93 patients). While there were minimal adverse effects reported, the researchers concluded there was platinum level evidence that ESWT provides little or not benefit in terms of pain and function for lateral elbow pain. For the trial of ESWT versus steroid injection, they found silver level evidence based on the one trial that steroid injection may be more effective than ESWT. In a randomized controlled study of 60 patients, Chung and Wiley (2004) concluded that despite improvement in pain scores and pain-free maximum grip strength within groups, there does not appear to be a meaningful difference between treating lateral epicondylitis with ESWT combined with forearm-stretching program and treating with forearm-stretching program alone, with respect to resolving pain within an 8-week period of commencing treatment. Stasinopoulos and Johnson (2005) concluded more research with well-designed randomized control studies is needed to establish the absolute and relative effectiveness of ESWT for tennis elbow. Additionally, in a systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia, Bisset et al (2005) stated that ESWT is not beneficial in the treatment of tennis elbow. A 2004 Technology Assessment from CTAF found pain from LE tends to resolve over extended periods of time, even for patients who have failed conservative therapy for many months. Therefore, uncontrolled studies of ESWT, while promising, may represent the natural history of the disorder abetted by a strong placebo effect. Studies with pain as the primary outcome commonly are subject to large placebo effects. Indeed, in non-blinded RCTs of ESWT, the placebo group usually reported minimal improvements while the placebo group in wellblinded studies reported 30-50% improvements in pain scores. The CTAF also highlighted results from a systematic review from 2000 that identified 20 studies of ESWT for lateral epicondylitis (Boddeker et al.). According to CTAF, each study had methodological flaws and there was no difference in the degree of improvement in pain between groups in higher quality RCTs. Both ESWT groups and sham ESWT groups showed improvements in pain, function and grip strength over six weeks to one year of follow-up. Between group differences were negligible and sometimes favored the sham group. At this time, there is not enough evidence in medical literature to support the efficacy of ESWT for lateral epicondylitis. 3. Benchmarks: BCBS MA: There are no covered indications for extracorporeal shock wave therapy in the treatment of musculoskeletal conditions at this time. https://www.bluecrossma.com/common/en_US/medical_policies/081%20Extracorporeal%20Shock%20Wave%20 Treatment%20for%20Plantar%20Fasciitis%20and%20Other%20Musculoskeletal%20Conditions%20prn.pdf Tufts Health Plan: Not covered http://www.tuftshealthplan.com/providers/pdf/mng/statements_of_non_coverage.pdf Fallon Community Health Plan: The Technology Assessment Committee (TAC) has determined that ESWT (highenergy and low-energy) is experimental/investigational for all indications, including, but not limited to, plantar fasciitis and lateral epicondylitis. http://www.fchp.org/NR/rdonlyres/64EE15CF-89BF-43EE-B4D8DDE8B41A0EC2/0/ESWTChronicPlantarFasciitisAndOther.pdf United Health Care: Extracorporeal shock wave therapy (ESWT), low energy, high energy or radial wave, is unproven for the treatment of: achilles tendonitis calcaneal spur calcific tendonitis of the shoulder (rotator cuff) chronic plantar fasciitis (including plantar fibromatosis and plantar nerve lesion) delayed or nonunion of fractures

 hammer toe lateral epicondylitis (tennis and golfers elbow) tenosynovitis of the foot or ankle tibialis tendinitis The available evidence regarding the efficacy of ESWT is conflicting. There is insufficient evidence regarding the durability of the treatment effects of ESWT. Patient selection criteria have not been adequately defined and optimal treatment parameters have not been established. https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/enUS/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/M edical%20Policies/Medical%20Policies/ESWT_Orthopedic_Indications.pdf Aetna: Aetna considers extracorporeal shock-wave therapy (ESWT) experimental and investigational for lateral epicondylitis (tennis elbow), rotator cuff tendonitis (shoulder pain), Achilles tendonitis, non-unions, or other musculoskeletal indications, or for wound healing because there is insufficient evidence of effectiveness of ESWT for these indications in the medical literature. http://www.aetna.com/cpb/medical/data/600_699/0649.html CIGNA: CIGNA does not cover extracorporeal shock wave therapy (ESWT) for the treatment of any musculoskeletal condition, because it is considered experimental, investigational or unproven. http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0004_coveragep ositioncriteria_eswt_for_musculoskeletal_conditions.pdf NICE: Interventional Procedures Overview - Extracorporeal shock wave therapy for refractory tendinopathies (plantar fasciitis and tennis elbow) May 2005: Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The procedure is novel and of uncertain safety and efficacy. There may be a strong placebo effect. The key efficacy outcomes are pain relief and improved function. There is variation in the equipment and energy levels used. Treatment may or may not be guided by ultrasound. This procedure has the potential to have a major impact on the NHS, in terms of numbers of patients eligible for treatment and the use of resources. http://www.nice.org.uk/nicemedia/pdf/ip/IPG139guidance.pdf 4. Governmental/Professional Agencies: FDA: Five devices are currently approved by the FDA for the application of ESWT to either plantar fasciitis or lateral epicondylitis. The OssaTron lithotriptor (HealthTronics Inc.) was approved by the FDA for chronic proximal plantar fasciitis on October 12, 2000, and approved for chronic lateral epicondylitis on March 14, 2003. The Dornier Epos Ultra (Dornier MedTech) was approved for chronic plantar fasciitis on January 15, 2002. Sonocur Plus (Siemens Medical Solutions USA Inc.) was approved on July 19, 2002 for the treatment of chronic lateral epicondylitis. The Orthospec ESWT System (Medispec Ltd.) and the Orbasone Pain Relief System (Orthometrix Inc.) were approved on April 1, 2005 and August 10, 2005, respectively, for chronic plantar fasciitis. CMS: No public policy

CPT Codes: 28890 Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia 0019T Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, low energy 0101T Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy 0102T Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle

Codes:

1. Hayes, Inc. Medical Technology Directory. Extracorporeal Shock Wave Therapy for Chronic Plantar Fasciitis. Lansdale, PA: Hayes, Inc.; August 2005. 2. Hayes, Inc. Medical Technology directory. Extracorporeal Shock wave Therapy for Chronic Lateral Epicondylitis of the Elbow. Lansdale, PA: Hayes, Inc. August 22, 2005. 3. Thomson, CE., Crawford, F., Murray, GD. The effectiveness of extra corporeal shock wave therapy for plantar heel pain: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2005, 6:19. 4. Kudo, P., Dainty, K., Clarfield, M., Coughlin, L., Lavoie, P., Lebrun, C. Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracorporeal shockwave therapy (ESWT) device: a North American confirmation study. Journal of Orthop Res. 2006, 24(2): 115-23 5. Malay, DS., Pressman, MM., Assili, A., Kline, JT., York, S., Buren, B., Heyman, ER., Borowsky, P., LeMay, C. Extracorporeal shockwave therapy versus placebo for the treatment of chronic proximal plantar fasciitis: results of a randomized, placebo-controlled, double-blinded, multicenter intervention trial. J Foot Ankle Surg. 2006, 24(4): 196-210. 6. Buchbinder, R., Ptasznik, R., Gordon, J., Buchanan, J., Prabaharan, B., Forbes, A. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial. JAMA. 2002, 288(11): 1364-72. 7. Tice, JA. California Technology Assessment Forum: Extracorporeal shock wave therapy for plantar fasciitis not responding to conservative therapy. October, 2009: http://www.ctaf.org/content/assessment/detail/1074 8. Buchbinder, R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004; 350(21): 2159-2166. 9. Burton, A., Overend, TJ. Low-energy extracorporeal shock wave therapy: A critical analysis of the evidence for effectiveness in the treatment of plantar fasciitis. Phys Ther Rev. 2005; 10(3): 152-162. 10. Boddeker, IR., Schafer, H., Haake, M. Extracorporeal shockwave therapy (ESWT) in the treatment of plantar fasciitis: A biometrical review. Clin Rheumatol. 2001; 20(5): 324-330. 11. Buchbinder, R., Green, SE., Youd, JM., Assendelft, WJ., Barnsley, L., Smidt, N. Systematic review of the efficacy and safety of shock wave therapy for lateral elbow pain. J Rheumatol. 2006; 33(7): 1351-63. 12. Chung, B., Wiley, JP. Effectiveness of extracorporeal shock wave therapy in the treatment of previously untreated lateral epicondylitis: A randomized controlled trial. Am J Sports Med. 2004; 32(7): 1660-1667. 13. Stasinopoulos, D., Johnson, MI. Effectiveness of extracorporeal shock wave therapy for tennis elbow (lateral epicondylitis). Br J Sports Med. 2005; 39(3): 132-136. 14. Bisset, L., Paungmali, A., Vicenzino, B., Beller, E. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia. Br J Sports Med. 2005; 39(7): 411-422; discussion 411-422. 15. Tice, JA. California Technology Assessment Forum: Extracorporeal shock wave therapy for the treatment of later epicondylitis. October, 2004: http://www.ctaf.org/content/assessment/detail/545 16. Boddeker, I., Haake, M. Extracorporeal shockwave therapy in treatment of epicondylitis humeri radials. A current overview. Orthopade; 2000; 29(5): 463-9.

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