Extracorporeal Shock Wave Lithotripsy (ESWL) for Gallstones
© Blue Cross and Blue Shield of Montana
Current Effective Date:
August 27, 2013
Original Effective Date:
August 27, 2013
May 27, 2013
This medical document is no longer scheduled for routine literature review and update.
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.”
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.
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.
- Extracorporeal Shock Wave Lithotripsy for Gallstones. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy reference Manual (July 2003) Surgery 7.01.35.
- 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.
||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.|