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Medical Policy

Policy Num:      07.001.034
Policy Name:    Lithotripcy, Extracorporeal Shock Wave (ESWL)
Policy ID           [07.001.034]  [Ar / L / M+ / P+]  [0.00.00]

Last Review:    June 26, 2023
Next Review:    Policy Archived
 

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Related Policies: None

Extracorporeal Shock Wave Lithotripsy (ESWL)
 

Summary 

OBJETIVE

The objectve of this review is to evaluate the benifit Extracorporeal Shock Wave Lithotripsy (ESWL) in the treatment of Kidney Stones.

Policy Statement

Extracorporeal Shock Wave Lithotripsy (ESWL) is considered for payment at the treatment of kidney stones.

The following situations must be met:

·    Calculi greater than 3mm in diameter.

·    No more than three calculi present.

·    The stone must be symptomatic and the chances of it passing spontaneously

      they should be low.

·     Urinary infections must be under control.

·     There should be no obstructions to the urinary tract.

·     The patient's anatomy should facilitate the procedure.

·     The treated kidney must be functional.

·     There should be no renal artery calcifications or renal artery aneurysms.

Policy Guidelines

N/A

Benefit Application

BlueCard/National Account Issues

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  

Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Kidney stones, also known as renal calculus, are pebble‐like solid crystal aggregations formed in the kidneys from minerals in the urine. Kidney stones typically leave the body by passage in the urine stream, and many stones are formed and passed without causing symptoms. If stones grow to sufficient size (usually at least three millimeters [0.12 inches]), they can block the ureter(s). This leads to pain, most commonly beginning in the lower back and often radiating to the groin or genitals. This pain is often known as renal colic and typically comes in waves lasting 20 to 60 minutes. Additional associated symptoms include nausea, vomiting, fever, blood or pus in the urine, and painful urination. Kidney stones are caused by not drinking enough water, limiting the ability of the body to dissolve uric acid. Some medications and supplements, such as vitamin D and calcium, can raise the risk of kidney stones. Most cases are observed in males, most commonly from ages 30 to 50. Drinking recommended amounts of water is also a precautionary measure to prevent kidney stones, along with taking certain medications.

The diagnosis of kidney stones is made on the basis of information obtained from the history, physical examination, urinalysis, and imaging studies (X‐rays, CT scans, or ultrasound). Urinary stones are typically classified by their location in the kidney, ureters, or bladder, or by their chemical composition (calcium‐containing, struvite, uric acid, or other compounds). About 80 percent of people with kidney stones are men. Blockage of the ureter(s) causes decreased kidney function and dilation of the kidney.

Lithotripsy is a noninvasive method of treating kidney stones with a device called a lithotripter. It uses shock waves generated outside the body to break up stones, focusing the waves on the stones by X‐ray visualization and repeated shock to pulverize them. Alternate treatments are surgical nephrotomy and transurethral ureteroscopic lithotripsy, which both remove stones using a cystoscope inserted into the ureter(s) via the bladder, and disintegrating them via mechanical crushing, electrohydraulic shock waves and/or laser. When a stone causes no symptoms, watchful waiting is a valid option. For stones that are causing symptoms, pain control is usually the first measure, using medications such as nonsteroidal anti‐ inflammatory drugs or opioids. More severe cases may require procedures. For example, some stones can be shattered into smaller fragments using lithotripsy. Some cases require more invasive procedures. Examples of these are cystoscopic procedures, such as laser lithotripsy, or percutaneous techniques, such as percutaneous nephrolithotomy. Sometimes, a tube (ureteral stent) may be placed in the ureter to bypass the obstruction and alleviate the symptoms, as well as to prevent ureteral stricture after ureteroscopic stone removal (Crosta, 2017).

Lower pole stones are kidney stones in an anatomic location that has a poor rate of spontaneous clearance. Even after therapy, stone fragments may linger in this location and lead to recurrent stones. Extracorporeal shock wave therapy is a treatment similar to lithotripsy, for certain musculoskeletal conditions. These include chronic plantar fasciitis, lateral epicondylitis (“tennis elbow”), medial epicondylitis (“golfers elbow”), hammer toe, stress fractures, and certain wounds (including ulcers).

A recent guideline of the American Urological Association consists of 56 recommendations, covering pre‐operative testing for renal or ureteral stones, along with treatment for adults, pediatric patients, and pregnant women. It found that among the numerous published studies of management of kidney and ureteral stones, lithotripsy has been associated with lower morbidity and complication rates, but also a lower stone‐free rate in a single procedure, compared with transurethral ureteroscopic lithotripsy (Assimos, 2016). This guideline built on findings subsequent to an earlier guideline from the European Association of Urology and American Urological Association panel, which compared the two procedures (Preminger, 2007). See appendix for lithotripsy‐related recommendations in the 2016 guideline.

RATIONAle

In a meta‐analysis of seven randomized controlled trials (n=1,205 adults) treated for ureteric stones, researchers found that lithotripsy patients had less need for auxiliary treatment, experienced fewer complications, and had shorter hospital stays than ureteroscopy patients; however, the lithotripsy group also had higher re‐treatment rates (Abourmarzouk, 2012). This review corroborated results of an earlier meta‐analysis (Nabi, 2007). The most recent, and perhaps most extensive systematic review comparing ureteroscopy and lithotripsy included 47 studies, 40 percent of which were randomized controlled trials. The stone‐free rate for ureteroscopy was significantly greater than lithotripsy at four weeks after the procedure, but there was no difference after three months. Ureteroscopy was associated with fewer retreatments and need for secondary procedures, but a higher need for adjunctive procedures, greater complication rates, and longer hospital stays (Drake, 2017).

A systematic review of eight controlled trials (n=876) randomized for lithotripsy patients receiving or not receiving stents found that stone‐free rates were no different between the groups, but that the stented group had a higher rate of urinary tract symptoms (Shen, 2011). Other systematic reviews showed lower stone‐free rates for lithotripsy patients (Matalga, 2012a; Cui, 2015; Xu, 2015). One of these reviews documented a greater likelihood of re‐treatment in the lithotripsy group, with no difference in complication risk (Matalga, 2012).

The ability of lithotripsy to successfully treat urolithiasis in pediatric patients (“could be considered a first‐line treatment”) was confirmed in a meta‐analysis of 14 studies (n=1,842), especially when stones were less than 10 millimeters in diameter (Lu, 2015). A review of 151 papers on pediatric lithotripsy revealed limited studies on long‐term effects, but widespread opinion that it does not adversely affect renal functions in the long term (Akin, 2014).  

Efficacy of lithotripsy was compared with percutaneous nephrolithotomy, another means of treating kidney and ureteral stones. In an analysis of five studies (n=338), success of treatment of nephrolithotomy was superior to lithotripsy in the need for auxiliary procedure use, need for re‐ treatment, and efficiency quotient (Sribubat, 2014). Lithotripsy had lower stone‐free rates when compared to nephrilithotomy in a 23‐study (n=2,494) systematic review (Tokas, 2017).

Lower‐pole stones, the most common renal calculi, are also the most likely to require treatment. One systematic review of eight controlled trials (n=691) found that lithotripsy patients had lower stone‐free rates for lower‐pole stones than those undergoing percutaneous nephrolithotomy and retrograde intrarenal surgery; the magnitude of the benefit was greatest for stones < 10 millimeters (Donaldson, 2015).

Long‐term effects of lithotripsy were considered in one systematic review. No evidence was found that lithotripsy increased rates of arterial hypertension, diabetes mellitus, kidney dysfunction, or infertility (Fankhauser, 2015). A meta‐analysis of 11 studies addressed the issue of whether lithotripsy was associated with new onset hypertension, but found no significant link (Yu, 2014).

A systematic review of six studies (n=711) compared outcomes of emergent and delayed lithotripsy for ureteral stones. Stone‐free status and likelihood of need for auxiliary maneuvers were significantly lower (superior) for emergent, compared to delayed, lithotripsy (p < .001). Complication rates between emergent and delayed procedures were not significantly different (Arcaniolo, 2017).

Population Reference No. 1

Use of extracorporeal shock wave lithotripsy (lithotripsy) has been clinically proven and, therefore, medically necessary for urinary tract stones, including staghorn and ureteric stones

Suplemental Information

N/A

References

1. Research was limited to English-language journals on humans. See also:

2. TEC Evaluation and Coverage 1988: p. 502

3. TEC Strategies: Extracorporeal Shock Wave Lithotripsy: Clinical Assessment, Utilization and Cost Projection; May 1985

4. Current Procedural Terminology (2016) American Medical Association

5.https://www.uptodate.com/contents/kidney-stones-in-adults-surgical-management-of-kidney-and-ureteral-stones?search=Extracorporeal%20lithotripsy&source=search_result&selectedTitle=1~67&usage_type=default&display_rank=1#H5286840

Codes

Policy History