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DESCRIPTIONExtracorporeal shockwave treatment (ESWT), also known as orthotripsy or lithotripsy, has been available since the early 1980s for the treatment of renal stones, and has been widely investigated for the treatment of biliary stones. Shock waves create a transient pressure disturbance, which disrupts solid structures, breaking them into smaller fragments, thus allowing spontaneous passage and/or removal of stones. The mechanism by which ESWT might have an effect on musculoskeletal conditions is not well defined. Chronic musculoskeletal conditions, such as tendinitis, can be associated with a substantial degree of scarring and calcium deposition. Calcium deposits may restrict motion and encroach on other structures such as nerves and blood vessels, causing pain and decreased function. One hypothesis is that disruption of these calcific deposits by shock waves may loosen adjacent structures and promote resorption of calcium, thereby decreasing pain and improving function.
Other functions are also thought to be involved. Physical stimuli are known to activate endogenous pain control systems and activation by shock waves may “reset” the endogenous pain receptors. Damage to endothelial tissue from ESWT may result in increased vessel wall permeability, causing increased diffusion of cytokines, which may in turn promote healing. Microtrauma induced by ESWT may promote angiogenesis and thus aid in healing. Finally, shock waves have been shown to stimulate osteogenesis and promote callous formation in animals, which is the rationale for trials of ESWT in delayed union or non-union of bone fractures.
Currently, five (5) ESWT devices are approved for marketing by the U.S. Food and Drug Administration (FDA). The OssaTron® device (HealthTronics, Marietta, Ga.), an electrohydraulic delivery system was approved by the FDA on July 20, 2000, for patients with chronic proximal plantar fasciitis—i.e., pain persisting more than six (6) months and not responding to conservative management. It is also FDA approved for treatment of lateral epicondylitis (tennis elbow). The Epos™ Ultra (Dornier, Germering, Germany), an electromagnetic delivery system, was approved by the FDA on January 15, 2002, for plantar fasciitis. The SONOCUR® Basic (Seimans, Erlangen, Germany) also uses an electromagnetic delivery system and was approved by the FDA for use in chronic lateral epicondylitis (symptoms unresponsive to conservative therapy for more than 6 months) on July 19, 2002. In 2005, the Orthospec™ Orthopedic ESWT (Medispec Ltd, Germantown, MD), an electrohydraulic spark-gap device, and the Orbasone™ Pain Relief System (Orthometrix, White Plains, NY), a high-energy sonic wave system, received approval for treatment of chronic proximal plantar fasciitis in patients 18 years of age or older.
Both high-dose and low-dose protocols have been investigated. A high-dose protocol consists of a single treatment of high energy shock waves (1300mJ/mm2). This painful procedure requires anesthesia. A low-dose protocol consists of multiple treatments, spaced one (1) week to one (1) month apart, in which a lower dose of shock waves is applied. This protocol does not require anesthesia. The FDA labeled indication for the OssaTron® and Epos™ Ultra device specifically describes a high-dose protocol, while the labeled indication for the SONOCUR® device describes a low-dose protocol.
Another type of ESWT, radial ESWT (rESWT) received pre-market approval (PMA) in May 2007. The FDA-approved device is the Doloclast (spelled Dolorclast in the PMA summary) from EMS Electro Medical Systems, Nyon, Switzerland. Radial ESWT is generated ballistically by accelerating a bullet to hit an applicator, which transforms the kinetic energy into radially expanding shock waves. Other types of ESWT produce focused shock waves that show deeper tissue penetration with significantly higher energies concentrated to a small focus. Radial ESWT is described as an alternative to focused ESWT and is said to address larger treatment areas, thus providing potential advantages in superficial applications like tendinopathies.
Plantar fasciitis is a very common ailment characterized by deep pain in the plantar aspect of the heel, particularly on arising from bed. While the pain may subside with activity, in some patients the pain may persist, interrupting activities of daily living. On physical examination, firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology of plantar fasciitis is unclear, although repetitive injury is suspected. Heel spurs are a common associated finding, although it has never been proven that heel spurs cause the pain. It should be noted that asymptomatic heel spurs can be found in up to 10% of the population.
Conservative therapy of plantar fasciitis is successful in the vast majority of cases. Rest or minimization of running or jumping is the cornerstone of therapy. Heel cups are sometimes helpful in alleviating symptoms, presumably by padding the heel and absorbing the impact of walking. Nonsteroidal anti-inflammatory drugs are also helpful in acute cases. If these measures are ineffective, a local injection of steroids may be effective. Improvement is frustratingly slow and gradual, taking up to a year in some cases.
Tendinitis of the Elbow (Lateral Epicondylitis)
Lateral epicondylitis is the most common form of tendinitis of the elbow, and results in lateral elbow pain and functional limitations. The disorder is caused by overuse or injury of the tendons that attach the arm muscles to the elbow, such as commonly occurs from playing tennis (“tennis elbow”). However, only a minority of cases is caused by playing tennis, the majority occur from other activities that involve repetitive extension of the wrist. Overuse of the extensor muscles lead to microtears at their insertion point, which incites an inflammatory response. Repetitive cycles of injury and inflammation lead to tendinitis, degeneration of the tendon structures, and disorganized healing.
The diagnosis of lateral epicondylitis is made by characteristic pain and tenderness at the lateral aspect of the elbow, in conjunction with typical activities or injury that accompany this condition. Radiologic imaging is not necessary for diagnosis, but may be useful in ruling out other causes of lateral elbow pain, such as fracture, dislocation, degenerative joint disease, and other bony or soft tissue pathologies. Imaging is usually normal in lateral epicondylitis, although occasionally calcium deposition can be seen.
Conservative treatment consists of rest, activity modification, anti-inflammatory medications, and/or physical therapy. Corticosteroid injections and orthotic devices can also be tried as adjuncts to conservative measures. A number of surgical treatments are available for patients who do not respond to conservative treatment; approximately 5%–10% of patients with tendinitis of the elbow require surgery. Surgery may be performed as open or laparoscopic procedures. The general approach is to debride any degenerative or nonviable tissue and to repair tears or other structural abnormalities.
ESWT is a noninvasive procedure for breaking up kidney stones. High intensity shock waves are produced electrically on the treatment area. ESWT treatment consists of approximately 500-1500 shocks delivered over 30-60 minutes. The size and number of stones to be treated usually determines the extent of therapy. The patient may be either submerged in water bath (wet method device) or have water-filled compressible pads positioned in the appropriate area (dry method device). General, spinal, or epidural anesthesia is usually administered with this procedure. Several machines under investigation only require local anesthetics. ESWT treatments can be performed on an inpatient or outpatient basis. Following ESWT, most kidney stone fragments are eventually eliminated in the urine. Adjunctive procedures (e.g., pre-ESWT endoscopy or surgery) are estimated to be required in 7-15% of patients to ensure the complete removal of the stone fragments.
Extracorporeal Shock Wave Treatment (ESWT) for salivary stones is a minimally invasive treatment for symptomatic salivary stones that disintegrates or fragments stones so that spontaneous or induced salivation can flush out the sandy material. There are two types of lithotripters designed to deliver shock waves to a small focus, decreasing the chance of damaging adjacent tissue. Thus, it is possible to disintegrate salivary stones into concretions of < 2 mm in diameter. The goals of treatment are removal of stones, restoration of saliva flow, and relief of symptoms.
POLICYExtracorporeal shock wave therapy (ESWT), using either a high- or low-dose protocol, is considered investigational, as a treatment of musculoskeletal conditions, including but not limited to plantar fasciitis; tendinopathies including tendinitis of the shoulder, tendinitis of the elbow (epicondylitis, tennis elbow), stress fractures, delayed union and non-union of fractures, and avascular necrosis of the femoral head.
Extracorporeal Shock Wave Treatment (ESWT) is considered investigational for salivary stones.
Extracorporeal Shock Wave Treatment (ESWT) for kidney stones is considered eligible for coverage.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
In 2000, Medstone, a manufacturer of an ESWT device, received FDA approval for ESWT in conjunction with urosdiol as a treatment of "symptomatic, solitary, radiolucent non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adult patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery."
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/1993: ESWT for Gallstones approved by Medical Policy Advisory Committee (MPAC)
9/1994: ESWT for Kidney Stone approved by Medical Policy Advisory Committee (MPAC)
4/6/2001: Policy reviewed; Title changed to "ESWT", ESWT for kidney stones policy combined with ESWT for gallstones policy, ESWT for salivary and pancreatic stones added to the policy, Managed Care Requirements deleted, Policy History updated, Sources updated
8/2001: Reviewed by MPAC; ESWT considered investigational for Musculoskeletal conditions, including, but not limited to, plantar fasciitis, chronic plantar fasciitis, heel pain syndrome, epicondylitis, tendonopathies including calcific tendinitis of the shoulder, stress fracture, delayed union and nonunion, and gallstones. Policy exception - FEP subscribers only - for ESWT treatment of gallstones added.
10/2/2001: New 2002 codes added
2/8/2002: Investigational definition added
4/22/2002: Type of Service and Place of Service deleted
5/7/2002: Code Reference section updated, ICD-9 diagnosis code 726.71, 726.72, 726.79, 726.90, 727.00, 727.01, 727.02. 727.03, 727.04, 727.05, 726.06, 727.09, 727.82, 728.71, 728.79, 728.86, 728.89, 729.4 added to non-covered codes
5/2002: Reviewed by MPAC, ESWT criteria for kidney stones deleted, ESWT for chronic plantar fasciitis considered medically necessary as an alternative to surgery with certain criteria, Sources updated, CPT code 0020T moved to covered.
5/29/2002: ICD-9 diagnosis code 593.89 added
6/6/2002: Code Reference section updated
9/20/2002: Code Reference section updated
11/2002: Reviewed by MPAC; no changes
2/3/2003: Code Reference section updated
3/17/2003: Code Reference section updated
4/8/2003: Code Reference section updated, CPT codes 28899, 52353 deleted, ICD-9 diagnosis codes 593.4, 593.81, 593.89 deleted, ICD-9 diagnosis code 726.71, 726.72, 726.79, 726.90, 727.00, 727.01, 727.02, 727.03, 727.04, 727.05, 727.06, 727.09, 727.82, 728.71, 728.79, 728.86, 728.89, 729.4, moved from non-covered to covered codes, ICD-9 diagnosis code 726.73, 788.0 added to covered codes
7/2003: Reviewed by MPAC; ESWT for pancreatic stones remains investigational, FEP exception added, Sources updated
11/2003: Reviewed by MPAC, Dornier Epos™ Ultra extracorporeal shock wave lithotripsy (ESWL) device added to “Description” , policy “Title’ changed from Extracorporeal Shock Wave Lithotripsy (ESWL) to Extracorporeal Shock Wave Treatment (ESWT), ESWL changed to ESWT as appropriate, hyperlink inserted, FEP exception musculoskeletal conditions added
1/21/2004: Code Reference section reviewed; no changes
1/23/2004: Code Reference section updated, ICD-9 diagnosis code range 727.00-727.09 listed separately, non-covered ICD-9 diagnosis codes 527.5, 574.20-574.21, 577.8, 719.47, 719.87, 726.10-726.12, 726.31, 726.32, 726.5, 726.61, 726.64, 726.8, 727.42, 727.60-726.69, 727.81, 727.89, 733.81, 733.82, 733.93, 733.94, 733.95 deleted, all non-covered codes were added 5-7-2002 except 574.00-574.91 code range added 4-8-2003 which was deleted also
6/4/2004: Code Reference section updated, ICD-9 diagnosis code 592.1, 592.9, 726.71, 726.72, 726.73, 726.79, 726.90, 727.00, 727.01, 727.02, 727.03, 727.04, 727.05, 727.06, 727.09, 727.82, 728.71, 728.79, 728.86, 728.89, 729.4, 788.0 deleted from covered codes
7/9/2004: FEP exception for kidney stones added
11/18/2004: Reviewed by MPAC, ESWT for pancreatic stones remains investigational
2/18/2005: Policy reviewed, Sources updated
7/19/2005: Code Reference section updated, CPT code 00872, 00873 added covered codes, ICD-9 procedure code 98.51, 98.59 description revised covered codes, CPT code 48999 added non-covered codes
3/24/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy
3/28/2006: Policy reviewed, no changes
10/16/2006: Peyronie's Disease added to the policy section as investigational
3/28/2007: Policy reviewed, no changes
6/15/2007: Policy reviewed, description updated to include musculoskeletal conditions plantar fasciitis and lateral epicondylitis. ESWT for plantar fasciitis changed to investigational. Removed the following policy statement: "Extracorporeal Shock Wave Treatment (ESWT) for chronic plantar fasciitis is considered medically necessary as an alternative to surgical therapy. Patients must meet the following criteria: (1) Symptoms persisiting for at least 6 months; AND (2) Lack a response to at least 3 other conservative treatments such as rest, physical therapy, anti-inflammatory medication, local corticosteriod injections, or heel orthotics."
7/19/2007: Reviewed and approved by MPAC
1/6/2009: Policy reviewed, no changes
04/22/2010: Policy description updated regarding FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.
08/02/2011: Policy revised to remove references to this procedure for Peyronie's Disease, pancreatic stones, and gallstones. Deleted the following procedure codes from the Code Reference section: 43265, 47999, 48999, 55899, S9034, and 98.52.
03/02/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes.
03/19/2014: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.40, #2.01.62
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
All codes billed for ESWT for salivary stones for this investigational procedure are not eligible for coverage.
Other applications of ESWT as a treatment of musculoskeletal conditions are considered investigational, including but not limited to plantar fasciitis; tendinitis of the elbow (epicondylitis, tennis elbow), tendinopathies including tendinitis of the shoulder, stress fracture, delayed union and nonunion of fractures, and avascular necrosis of the femoral head.