Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions

Policy #:11.14.13g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Extracorporeal shock wave therapy (ESWT) (high- or low-dose protocol, or radial ESWT) for the treatment of any musculoskeletal condition is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, extracorporeal shock wave therapy (ESWT) is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for ESWT.

Description

Extracorporeal shock wave therapy (ESWT), also known as orthotripsy, has been available since the 1980s and is used for the treatment of renal stones. ESWT is a noninvasive method that utilizes shock waves that are directed from outside the body onto a specific area being treated. Shock waves create a transient pressure disturbance that affects solid structures, breaking them into smaller fragments, allowing passage and/or removal of stones. The shock waves generated by ESWT may also increase the diffusion of cytokines across vessel walls, stimulate angiogenesis, and promote new bone formation.

There are several ESWT devices currently approved by the US Food and Drug Administration (FDA). The OssaTron® lithotripter (HealthTronics; Marietta, GA) is an electrohydraulic, high-energy device, approved for the treatment of plantar fasciitis and lateral epicondylitis that have failed conservative treatment after six months. The Epos Ultra® high-energy device (Dornier Medical Systems; Germering, Germany) uses electromagnetic energy to generate shock waves and is approved for the treatment of chronic plantar fasciitis. The SONOCUR® Basic (Siemens; Erlangen, Germany), a low-dose electromagnetic delivery system, is approved for the treatment of chronic lateral epicondylitis. More recent FDA-approved devices for the treatment of plantar fasciitis include the Orthospec(Medispec, Ltd, Germantown, MD) and the Orbasone Pain Relief System (Orthometrix, Inc., White Plains, NY). Both are electrohydraulic devices that utilize the spark gap method to create a shock wave.

Typically, ESWT devices administer high- and low-energy shock waves. Both protocols have been investigated. A high-dose protocol of ESWT requires anesthesia and is typically given in one treatment. A low-dose protocol of ESWT does not require anesthesia and usually consists of three to five treatments, performed from one week to one month apart.

Another type of ESWT, called radial ESWT (rESWT) received pre-marketed approval (PMA) in May of 2007, with the FDA-approved device, EMS Swiss Dolorclast®. The Swiss Dolorclast® is marketed by Electro Medical Systems [EMS], based in Nyon, Switzerland. The FDA-approved indications for use of this device are chronic proximal plantar fasciitis, with symptoms for six months or more, and a history of unsuccessful conservative therapy, in individuals 18 years of age and older. The Swiss Dolorclast® consists of a control unit and a handpiece with the treatment applicator mounted on the end. The treatment applicator is held in contact with the heel. Compressed air is used to drive a projectile (metal cylinder) within the handpiece toward the applicator. When the projectile hits the applicator inside the handpiece, a shock wave is transferred to the treatment site. The highest energy density will be at the point of contact of the applicator (the treatment site), but the shockwave will travel radially outward into the soft tissue surrounding the point of contact. Studies utilizing rESWT continue to provide weak or contradictory evidence and efficacy for all musculoskeletal conditions.

ESWT has been studied in the treatment of various musculoskeletal conditions, including plantar fasciitis, tennis or golfer's elbow, rotator cuff injuries, bursitis, and other overuse injuries. All these conditions consist of a complex syndrome of tendinitis, inflammation, adhesions, and the buildup of calciferous deposits in the affected area. These musculoskeletal conditions have traditionally been treated with rest, ice, massage, anti-inflammatory medications, ultrasound, acupuncture, physical therapy, and surgery. The main outcomes evaluated in the treatment of chronic musculoskeletal conditions are improvements in pain and function (eg, activity).

PLANTAR FASCIITIS

Plantar fascia is a band of connective tissue on the plantar surface of the heel that helps maintain the normal architecture of the foot. Overuse or injury of the plantar fascia leads to inflammation of this region, causing pain and restricted motion. Pain is usually worse upon rising in the morning and can be provoked by prolonged standing, walking, or running during the day.

Diagnosis is primarily made by history and physical examination. Important factors in diagnosis are a pattern and character of heel pain that is consistent with plantar fasciitis and elicitation of tenderness at the origin of the plantar fascia on physical examination. Specialized testing, such as imaging studies, is usually not necessary.

The initial treatment of plantar fasciitis is rest, stretching exercises, and/or anti-inflammatory medications. If these initial measures are unsuccessful, heel orthotics such as a heel wedge or a night splint are often attempted. Local injection of corticosteroids is also used for individuals who do not respond to simpler treatments. With time, most individuals respond to one or more of these conservative measures; however, relapses are common and can be frequent despite therapy.

In a multicenter double blinded randomized trial, Gerdesmeyer et al. (2008) sought to determine if a difference in effectiveness between radial extracorporeal shock wave therapy and placebo in the treatment of chronic plantar fasciitis. The authors randomized N= 252 patients to received either rESWT (n=129) or to sham treatment (n=122). Prior to study enrollment, individuals had heel pain for at least 6 months and failure of at least 2 nonpharmacologic and 2 pharmacologic treatments. Treatment consisted of three treatments at weekly intervals; and more than 90% of patients in each group had all 3 treatments. Primary outcomes were composite heel pain (pain on first steps of the day, with activity and as measured with Dolormeter), change in individual VAS scores, and RM score measured at 12 weeks and 12 months. Success was defined as at least 60% improvement in 2 of 3 VAS scores or, if less pain reduction, then the patient had to be able to work and complete activities of daily living, had to be satisfied with the outcome of the treatment, and must not have required any other treatment to control heel pain. Additional outcomes also evaluated at 12 weeks were changes in RM score, SF-36 physical percent changes, SF-36 mental percent changes, investigator’s judgment of effectiveness, patient’s judgment of therapy satisfaction, and patient recommendation of therapy to a friend. The authors reported, at the 12-week follow-up point, rESWT was followed by a decrease of the composite VAS score of heel pain by 72.1% versus 44.7% after placebo (p=0.022). The success rate for the composite score was 61% versus 42% (p=0.002). Statistically significant differences were also reported on all secondary measures at 12-weeks. Despite the positive outcomes numerous limitations serve to preclude the ascertainment of conclusions including but not limited to; an inadequate description of prior treatment (or intensity of treatment) provided before referral to the study, the use of the composite outcome measure and its clinical significance, no data on the use of rescue medication, and inadequate participant blinding.

More recently, Rompe et al. (2010) compared the effectiveness of plantar fascia-specific stretching and shock-wave therapy for among N=102 treatment naive individuals with a history of unilateral plantar fasciopathy for a maximum duration of 6 weeks. Participants were randomized to perform an 8-week plantar fascia-specific stretching program (group I, n = 54) or to receive repetitive low-energy radial shock-wave therapy without local anesthesia, administered weekly for 3 weeks (group II, n = 48). Participants were evaluated at baseline and at 2, 4, and 15 months after baseline using a 7-item pain subscale of the validated Foot Function Index and a patient-relevant outcome questionnaire. Primary outcome measures were a mean change in the Foot Function Index sum score at 2 months after baseline, a mean change in item 2 (pain during the first few steps of walking in the morning) on this index, and satisfaction with treatment. Primary outcomes were a mean change in the Foot Function Index sum score at 2 months after baseline, a mean change in item 2 (pain during the first few steps of walking in the morning) on this index, and satisfaction with treatment. At two months following baseline assessment, the authors observed significantly greater changes, in regard to the Foot Function Index sum score, for the patients managed with plantar fascia-specific stretching than for those managed with shock-wave therapy (p < 0.001), as well as individually for pain during the first few steps of walking in the morning (p = 0.002). At 15 months after baseline, no significant between-group difference was measured. Based on these findings, the authors concluded that a program of manual stretching exercises specific to the plantar fascia is superior to repetitive low-energy radial shock-wave therapy for the treatment of acute symptoms of proximal plantar fasciopathy.

In 2013 Dizon et al. published results from systematic review and meta-analysis of clinical trials, published between 2002 and 2010, with the intention to evaluate the effectiveness of ESWT in treating chronic plantar fasciitis. The authors identified n=11 randomized trials (n=1287 participants) that compared ESWT to placebo or standard medical management. The primary outcome measure of interest was overall pain reduction assessed 12 weeks after intervention; with other outcomes including pain during the first few steps in the morning and during activity. The authors reported that compared to placebo control, ESWT was more effective in reducing morning pain (p=0.004). There was no difference between ESWT and control in decreasing overall pain, (p= 0.06), however moderate-intensity ESWT was more effective in decreasing overall and activity pain (p<0.00001). While acknowledging the lack of consistency in outcome measures, specified dose intensities, and follow-up; the authors concluded that moderate- and high-intensity ESWT were effective in the treatment of chronic plantar fasciitis.

In a meta-analysis published in 2017, Sun et al. reported on nine studies totaling 935 participants evaluating the different approaches to extracorporeal shock wave therapy (i.e, general ESWT, focused shock wave [FSW], radial shock wave [RSW]) compared to placebo in the treatment of chronic plantar fasciitis. The primary outcomes was defined as a 50-60 % reduction in visual analogue scale (VAS) from baseline. The authors reported general ESWT produced greater improvements than placebo (OR 2.58, 95 % CI, 1.97-3.39, P <.00001). Subgroup analysis for FSW (n= 474) and RSW (n=461) were performed and resulted in significant improvements compared to placebo (P <0.0001) in the FSW and (P =0.02) for the RSW. The authors reported general ESWT as an effective treatment for chronic PF, and the FSW group reported higher success rate and greater pain reduction compared to sham control. The RSW group reported a high degree of heterogeneity across the studies limiting the effectiveness of treatment. Additional studies are required to compare efficacy and functional recovery between FSW and RSW.

Clinical practice guidelines published in 2010 by Thomas et al. on behalf of the American College of Foot and Ankle Surgeons describes EWST as a third tier treatment modality in patients who have failed other interventions, including steroid injection. Additional guidelines National Institute for Clinical Excellence (NICE) concluded that the current evidence on the efficacy of ESWT for refractory tennis elbow, Achilles tendinopathy, and plantar fasciitis is inconsistent and the procedure should only be used with special arrangements for clinical governance, consent and audit or research.

LATERAL EPICONDYLITIS (TENDINITIS OF THE ELBOW)

Lateral epicondylitis, the most common form of tendinitis of the elbow, results in lateral elbow pain and functional limitations. This is caused by overuse or injury of the tendons that attach the arm muscles to the elbow, which commonly occurs from playing tennis (also known as tennis elbow). Overuse of the extensor muscles leads to micro tears at their insertion point, which incites an inflammatory response. Repetitive cycles of injury and inflammation lead to tendinosis, degeneration of the tendon structures, and disorganized healing.

The diagnosis of lateral epicondylitis is made by characteristic pain, tenderness, and injuries at the lateral aspect of the elbow.

The condition is treated conservatively with rest, activity modification, anti-inflammatory medications, and physical therapy. Corticosteroid injections and orthotic devices may also be used as adjuncts to conservative measures. Surgery is an alternative for individuals who do not respond to conservative treatment.

In 2005 Pettrone et al. enrolled N=114 individuals in a randomized double blinded controlled trial at 3 orthopedic practices in an effort to evaluate the use of ESWT in the treatment of lateral epicondylitis. Study participants were randomized to receive either ESWT in a "focused" manner (2000 impulses at 0.06 mJ/mm2 without local anesthesia) weekly for 3 weeks or placebo. Patients underwent physical examinations, including provocation testing and dynamometry at one, four, eight, and twelve weeks most treatment as well as six and twelve months post treatment. The primary endpoint was a 50% reduction in the provocation in pain on the Thompson test. Pain assessed on the VAS (scaled here to 10 points) declined at 12 weeks in the treated group from 7.4 to 3.8; among placebo patients from 7.6 to 5.1. A reduction in Thomsen test pain of at least 50% was demonstrated in 60.7% of those treated compared with 29.3% in the placebo group. Mean improvement on a 10-point UEFS activity score was 2.4 for ESWT-treated patients compared with 1.4 in the placebo group—difference at 12 weeks of 0.9 (95% CI, 0.18 to 1.6). These data lead the authors to conclude that low-dose shock wave therapy without anesthetic is a safe and effective despite the observation of a large placebo effect among the study participants.

Buchbinder et al. (2005) published results of a Cochrane Collaboration systematic review in order to determine the effectiveness and safety of ESWT for lateral elbow pain. The reviewers identified nine trials consisting of n=1006 participants randomized to ESWT or placebo and one trial that randomized n=93 participants to EWST or steroid injection. Five of the studies showed that pain, function and grip strength was the same or slightly more improved with shock wave therapy than with placebo. Four studies demonstrated more improvement with shock wave therapy than placebo therapy. Eleven of thirteen pooled analyses found no significant benefit of EWST over placebo. Specifically, the weighted mean difference for improvements in pain (on a100 point scale) from baseline to 4-6 weeks among a pooled analysis of three trials (n=466 individuals) was -9.42 (95% CI -20.70 to 1.86) and the weighted mean difference for improvement in pain (on a 100-point scale) provoked by resisted wrist extension (Thomsen test) from baseline to 12 weeks from a pooled analysis of three trials (455 participants) was -9.04 (95% CI -19.37 to 1.28). Considering these and other results, the Buchbinder workgroup concluded that based upon systematic review of nine placebo controlled trials involving 1006 participants, there is 'Platinum' level evidence that shock wave therapy provides little or no benefit in terms of pain and function in lateral elbow pain.

A more recent systematic review published by Dingemanse et al. in 2014 resulted in similar unequivocal conclusions regarding the efficacy of ESWT for the treatment of epicondylitis. Specifically the authors concluded that the evidence is conflicting on the short-term benefits of ESWT; with no evidence demonstrating any long-term benefits with ESWT over placebo for epicondylitis treatment.

Clinical practice guidelines National Institute for Clinical Excellence (NICE) concluded that the current evidence on the efficacy of ESWT for refractory tennis elbow, among other conditions, is inconsistent and the procedure should only be used with special arrangements for clinical governance, consent and audit or research.

SUMMARY

There is insufficient evidence on low-energy ESWT for individuals with plantar fasciitis. Literature studying this treatment for individuals with plantar fasciitis who have failed conservative therapies show conflicting results. There were no clinically significant benefits in any outcome studied (e.g., subjective improvement, pain scores) at three months and even long term (i.e., one year) following treatment. The results on the use of high-energy ESWT are more promising; however, conflicting results showed only one single-blinded study producing clinically significant improvements. For these reasons, more studies are needed before definitive conclusions can be reached. Limited studies also show insufficient and inconsistent evidence to conclude that ESWT improves net health outcomes for lateral epicondylitis.

Other musculoskeletal conditions not supported by published literature, include but are not limited to the use of ESWT for:
  • Stress fracture
  • Delayed union and nonunion of bone fractures
  • Avascular necrosis of the femoral head
  • Osteochondritis dissecans
  • Patellar tendinitis
  • Achilles tendinitis and other forms of chronic tendinitis
  • Tendinitis of the shoulder

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van Leeuwen MT, Zwerver J, van den Akker-Scheek I. Extracorporeal shockwave therapy for patellar tendinopathy; a review of the literature. Br J Sports Med. 2009;43(3):163-8.

Verstraelen FU, In den Kleef NJ, Jansen L, et al. High-energy versus low-energy extracorporeal shock wave therapy for calcifying tendinitis of the shoulder: which is superior? A meta-analysis. Clin Orthop Relat Res. 2014;472(9):2816-2825.

Vidal X, Morral A, Costa L et al. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: A randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011; 29(4):413-9.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

0101T, 0102T, 28890

THE FOLLOWING CODE IS USED TO REPRESENT EXTRACORPOREAL SHOCK WAVE INVOLVING MUSCULOSKELETAL SYSTEM, LOW ENERGY

20999


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions from 11.14.13g
04/11/2018The policy has undergone a routine review, and no revisions have been made.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 01/01/2017
Version Issued Date: 12/30/2016
Version Reissued Date: 04/11/2018

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