Medicare Advantage

Medical Policy

Title:

Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions

Policy #:

MA11.087c

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.

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

This policy is consistent with Medicare's coverage determination.

BENEFIT APPLICATION

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

Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. 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 6 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 1 week to 1 month apart.

Another type of ESWT, called radial ESWT (rESWT) received premarketed approval (PMA) in May 2007, with the FDA-approved device, EMS Swiss DolorClast®. The Swiss DolorClast is marketed by Electro Medical Systems (EMS; Nyon, Switzerland). The FDA-approved indications for use of this device are chronic proximal plantar fasciitis, with symptoms for 6 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 (e.g., 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-blind randomized trial, Gerdesmeyer et al. (2008) sought to determine if there was a difference in effectiveness between rESWT and placebo in the treatment of chronic plantar fasciitis. The authors randomly assigned individuals (N=252) to receive 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 two nonpharmacologic and two pharmacologic treatments. Treatment consisted of three treatments at weekly intervals; more than 90% of participants in each group had all three treatments. Primary outcomes were composite heel pain (pain on first steps of the day, with activity and as measured with dolorimeter), change in individual Visual Analog Scale (VAS) scores, and Roles and Maudsley (RM) score measured at 12 weeks and 12 months. Success was defined as at least 60% improvement in two of three VAS scores or, if less pain reduction, then the participant 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, the participant's judgment of therapy satisfaction, and participant recommendation of therapy to a friend. The authors reported, at the 12-week follow-up point, that 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 treatment-naive individuals (N=102) with a history of unilateral plantar fasciopathy for a maximum duration of 6 weeks. Participants were randomly assigned 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 seven-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 2 months following baseline assessment, the authors observed significantly greater changes, in regard to the Foot Function Index sum score, for the participants 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 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 ESWT (i.e., general ESWT, focused shock wave [FSW], radial shock wave [RSW]) compared with placebo in the treatment of chronic plantar fasciitis. The primary outcomes were defined as a 50% to 60% reduction in VAS from baseline. The authors reported general ESWT produced greater improvements than placebo (odds ratio [OR] 2.58, 95% confidence interval [CI], 1.97–3.39; P<0.00001). 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 plantar fasciitis, 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.

In a systematic review and meta-analysis, Li et al. (2018) assessed randomized controlled trials (RCTs) to determine whether ESWT or corticosteroid injections are more effective in plantar fasciitis pain reduction (measured using VAS), treatment success, recurrence rate, function scores, and adverse events. The review included nine RCTs with a total of 658 cases in which 330 participants received ESWT and 328 received corticosteroid injection. Meta-analyses showed that corticosteroid injection is more effective than low-intensity ESWT at VAS reduction (3 months posttreatment: mean difference [MD], −1.67; 95% CI, −3.31 to −0.04; P=0.04; I2=85%). However, high-intensity ESWT is more effective than corticosteroid injection (2 to 3 months posttreatment: MD, 1.12; 95% CI, 0.52–1.72; P=0.0003; I2=59%). One study followed participants for 12 months posttreatment and found no significant difference in pain outcomes, and another found no significant difference in recurrence rates or functional scores between ESWT and corticosteroid injection. Four ESWT recipients in a single trial reported severe headache or migraine following the procedure; no severe adverse effects were reported for corticosteroid injection. Although corticosteroid injection is more readily available than ESWT, the authors reported that ESWT recipients had a faster return to full activities after the procedure. One limitation of this systematic review is the inclusion of only nine trials with 658 cases, only two of which were followed up for as long as 1 year. Also, the doses of corticosteroid injection varied across studies, which may affect heterogeneity.

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 participants in whom other interventions have failed, including steroid injection.

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 microtears 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.

A meta-analysis by Zheng et al. (2020) of nine studies concluded that ESWT does not reduce the mean overall pain compared with placebo in lateral epicondylitis of the humerus. A systematic review and meta-analysis by Yoon et al. (2020) of 12 studies revealed that ESWT lacks clinically important pain reduction or improvement in grip strength compared with sham stimulation or no additional treatment in participants with lateral epicondylitis. A meta-analysis by Karanasios et al. (2021) of 27 randomized trials (N=1871) found that ESWT (alone or as an additive intervention) compared with sham or other control treatment in participants with lateral elbow tendinopathy did not provide clinically meaningful improvement in pain intensity, elbow disability, or grip strength. A systematic review and network meta-analysis by Liu et al. (2022) of 40 RCTs found that ESWT was the optimal intervention for improving short-term and medium-term grip strength compared to several injection therapies.

Kaplan et al. (2023) reported on an investigator-blinded trial that randomized 87 participants with lateral epicondylitis to focused shock wave (FSW), radial shock wave (RSW), or sham treatment. Both ESWT groups experienced significant reductions in Patient-Rated Tennis Elbow Evaluation (PRTEE) scores from baseline to weeks 5 and 13 (P<0.001); the sham group did not demonstrate statistically significant differences from baseline to week 5 or 13 (P>0.05). The difference between sham and both FSW and RSW groups was significant for all PRTEE score changes (pain, function, and total) (P<0.001). Additionally, FSW was superior to RSW for changes in PRTEE pain, function, and total scores from baseline to weeks 5 and 13.

Aldajah et al. (2022) compared ESWT (n=20) with conventional physiotherapy (n=20) in participants with lateral epicondylitis. All participants received five sessions during the treatment program. Outcome measures included changes in VAS for pain intensity, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper extremity function, and dynamometer for maximal grip strength. Participants in both groups improved significantly after treatment in terms of VAS, DASH scores, and maximal grip strength from baseline. However, participants in the ESWT arm performed better than those in the physiotherapy arm for all outcomes. This RCT is not included in the summary table because it compares ESWT with a physiotherapy program that includes ultrasound therapy.

A systematic review published by Dingemanse et al. (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.

In 2005, Pettrone and McCall enrolled 114 individuals in a randomized double-blind controlled trial at three orthopedic practices to evaluate the use of ESWT in the treatment of lateral epicondylitis. Study participants were randomly assigned to receive either ESWT in a "focused" manner (2000 impulses at 0.06 mJ/mm² without local anesthesia) weekly for 3 weeks or placebo. Participants underwent physical examinations, including provocation testing and dynamometry at 1, 4, 8, and 12 weeks posttreatment as well as 6 and 12 months posttreatment. 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 participants 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 Upper Extremity Function Scale activity score was 2.4 for ESWT-treated participants compared with 1.4 in the placebo group—difference at 12 weeks of 0.9 (95% CI, 0.18–1.6). From these data, the authors concluded that low-dose shock wave therapy without anesthetic is safe and effective despite the observation of a large placebo effect among the study participants.

Buchbinder et al. (2005) published results of a Cochrane systematic review to determine the effectiveness and safety of ESWT for lateral elbow pain. The reviewers identified nine trials consisting of 1006 participants randomly assigned to ESWT or placebo and one trial that randomly assigned 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 13 pooled analyses found no significant benefit of EWST over placebo. Specifically, the weighted mean difference for improvements in pain (on a 100-point scale) from baseline to 4 to 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 on 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.

The most direct evidence on the use of ESWT to treat lateral epicondylitis comes from multiple small RCTs, which did not consistently show outcome improvements beyond those seen in control groups. The highest quality trials tend to show no benefit, and systematic reviews have generally concluded that the evidence does not support a treatment benefit over placebo or no treatment.

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

OTHER CONDITIONS

Other musculoskeletal conditions not supported by published literature include, but are not limited to, the use of ESWT for:

Shoulder tendinopathy
Patellar tendinitis
Stress fracture
Osteochondritis dissecans
Delayed union and nonunion of bone fractures
Spasticity
Avascular necrosis of the femoral head
Achilles tendinitis and other forms of chronic tendinitis
Tendinitis of the shoulder

References

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Staples MP, Forbes A, Ptasznik R, et al. A randomized controlled trial of extracorporeal shock wave therapy for lateral epicondylitis (tennis elbow). J Rheumatol. 2008;35(10):2038-2046.

Sun J, Gao F, Wang Y, et al. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: A meta-analysis of RCTs. Medicine (Baltimore). 2017;96(15):e6621.

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Coding

CPT Procedure Code Number(s)

0101T, 0102T, 28890

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

20999

ICD - 10 Procedure Code Number(s)

N/A

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

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.087c:

03/04/2026	This policy has been reissued in accordance with the Company's annual review process.
07/09/2025	The policy has been reviewed and reissued to communicate the Company’s continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
02/21/2024	The policy has been reviewed and reissued to communicate the Company's continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
02/22/2023	This policy has been reissued in accordance with the Company's annual review process.
05/18/2022	The policy has been reviewed and reissued to communicate the Company's continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
01/01/2022	Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. This policy has been identified for the CPT code update, effective 01/01/2022. The following CPT codes have revised narratives: 0101T and 0102T.

Revisions From MA11.087b:

06/02/2021	The policy has been reviewed and reissued to communicate the Company's continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
04/22/2020	The policy has been reviewed and reissued to communicate the Company's continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
06/05/2019	The policy has been reviewed and reissued to communicate the Company's continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
04/11/2018	The policy has been reviewed and reissued to communicate the Company's continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
06/21/2017	This policy has been reissued in accordance with the Company's annual review process.
01/01/2017	This policy has been identified for the CPT code update, effective 01/01/2017. The following CPT code has been removed from this policy and is replaced by the following NOC code: DELETED: 0019T REPLACED WITH: 20999

Revisions From MA11.087a:

03/16/2016	The policy has been reviewed and reissued to communicate the Company’s continuing position on Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions.
02/25/2015	This policy was reviewed and passed though the update process for quality assurance purposes. No changes to policy statements or background have occurred.

Revisions From MA11.087:

01/01/2015

This is a new policy.

Version Effective Date:

1/1/2024

Version Issued Date: