BlueCross and BlueShield of Montana Medical Policy/Codes
Extracorporeal Shock Wave Lithotripsy (ESWL) for Gallstones
Chapter: Surgery: Procedures
Current Effective Date: August 27, 2013
Original Effective Date: August 27, 2013
Publish Date: May 27, 2013
Revised Dates: This medical document is no longer scheduled for routine literature review and update.
Description

Extracorporeal shock wave lithotripsy (ESWL) for gallstones is a non-invasive procedure for disintegrating gallstones.  High-intensity shock waves (500 to 1500 shocks over 30 to 120 minutes) are focused sonographically on the gallstones.  Originally, ESWL was used in isolation for treatment of gallstones, but subsequently patients were additionally treated with Ursodiol, a naturally occurring biliary acid that functions to further dissolve the fragmented stones.  Patients are typically treated with Ursodiol for a week before the procedure and after the procedure until stone clearance has been documented or up until 20 months.

In 2000, Medstone, a manufacturer of an ESWL device, received approval by the FDA for ESWL in conjunction with Ursodiol as a treatment of “symptomatic, solitary, radiolucent non-calcified gallstones (between 4 mm 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.”

Policy

Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review is performed if services are not prior authorized.

Medically Necessary

BCBSMT may consider extracorporeal shock wave lithotripsy (ESWL) for gallstones, in conjunction with Ursodiol therapy, medically necessary only in that small subset of patients with symptomatic non-calcified single gallstones measuring 20 mm or less AND who are either not considered candidates for either open or laparoscopic cholecystectomy due to comorbidities, or who actively refuse a surgical option.

Note: The U.S. Food and Drug Administration (FDA) approved use of biliary lithotripsy includes the administration of Ursodiol two weeks prior to the procedure and continues up to 20 months after or until a stone free state is achieved.  Since Ursodiol is a self-administered drug, pharmacy benefits may apply.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

2000 - 2003

Enthusiasm for ESWL treatment of gallstones was initially prompted by successful ESWL treatment of kidney stones.  Fragmented renal stones could be flushed out relatively easily through the urinary flow.  However, in the dependent gallbladder, the fragmented gallstones were often retained and could lead to recurrent biliary colic.  In the early 1990’s interest in ESWL of gallstones waned as laparoscopic cholecystectomy emerged as the treatment of choice for symptomatic cholelithiasis.  Research on ESWL treatment of gallstones refocused on its use as an adjunct to Ursodiol treatment.  In this setting, ESWL was used as a treatment to increase the effectiveness of Ursodiol therapy by fragmenting the stones thus increasing their surface area.  In fact, the clinical studies presented to the FDA as part of the approval process, focused on the ability of ESWL to enhance the effectiveness of Ursodiol alone.  The labeled indication of ESWL for gallstones suggests that the drug be given two weeks prior to ESWL and then continued up to 20 months after ESWL or until a stone-free state is achieved.

The FDA approval was based on several different studies performed in the 1980’s.  The data from these studies were reanalyzed to permit a comparison between the outcomes of Ursodiol treatment alone and Ursodiol treatment combined with ESWL treatment.  This complex statistical analysis is difficult to follow in the available FDA advisory committee minutes. However, the data suggest that the clearance rate of gallstones was 60% better in those receiving the combined therapy compared to those receiving ursodiol alone.  The best results were seen in those with a single non-calcified gallstone measuring less than 20 mm in diameter.  However, it is clear that cholecystectomy still represents the treatment of choice, due to the prompt resolution of symptoms in appropriately selected patients and the absence of stone recurrence, which may recur at a rate of 10% per year in the absence of cholecystectomy.  Approximately 500,000 patients per year undergo cholecystectomy.  Of these, perhaps 150,000 would be considered candidates on the basis of stone number and size alone.  Only a small percentage of these patients would not be considered surgical candidates.

A search and review of scientific literature conducted through July 2007 did not identify any published peer-reviewed literature that addresses the indications and limitations noted in the above discussion.  Therefore, the coverage position of this medical policy remains unchanged.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes
98.52, 574.00 - 574.91
Procedural Codes: S9034
References
  1. Extracorporeal Shock Wave Lithotripsy for Gallstones.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy reference Manual (July 2003) Surgery 7.01.35.
  2. Amplatz, S., Plazzi, L., et al.  Extracorporeal shock wave lithotripsy for clearance of refractory bile duct stones.  Digestive and Liver Disease (2007 March) 39(3):267-72.
History
May 2013  New 2013 BCBSMT medical policy.  Extracorporeal shock wave lithotripsy (ESWL) for gallstones, in conjunction with Ursodiol therapy, may be considered medically necessary only in that small subset of patients with symptomatic non-calcified single gallstones measuring 20 mm or less AND who are either not considered candidates for either open or laparoscopic cholecystectomy due to comorbidities, or who actively refuse a surgical option.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Extracorporeal Shock Wave Lithotripsy (ESWL) for Gallstones