Date Printed: February 9, 2010: 06:18 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2010, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2010 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® is a trademark of the American Medical Association.

02-54000-21

Original Effective Date: 03/15/05

Reviewed: 02/26/09

Revised: 01/01/10

Subject: Temporary Prostatic Stent

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

DESCRIPTION:

Prostatic obstruction is a common condition with a variety of etiologies. Benign prostatic hyperplasia (BPH) is the most common etiology, but obstruction may also occur acutely after surgical treatment for BPH, prostatic cancer, or after radiation therapy. Intraprostatic stenting has been investigated as a short- term treatment option permitting volitional urination as an alternative to the commonly used Foley catheter in which urine is collected in an external bag. In addition to volitional urination, the ideal temporary stent would be one that could be easily inserted and removed without migration, permitting adequate emptying of the bladder without disrupting the external sphincter such that continence could be maintained.

One temporary stent, The Spanner™ (Abbeymoore Medical) is composed of a proximal balloon to prevent distal displacement, a urine port situated anterior to the balloon, and a reinforced stent of various lengths to span most of the prostatic urethra. The distal anchor is shaped like a teardrop and positioned in the distal meatus. As the patient voids, the force of the urine compresses the device against the sides of the meatus, thus minimally obstructing the urine flow. Sutures attach a distal anchor mechanism. Finally, a retrieval suture extends to the meatus and deflates the proximal balloon when pulled. The device is inserted in an outpatient procedure under topical anesthesia.

In December 2006, the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for The Spanner (Abbeymoore Medical). The FDA PMA was based on a multi-center, prospective, controlled, randomized clinical investigation designed to evaluate the safety and effectiveness of The Spanner to manage lower urinary symptoms and bladder emptying after transurethral microwave thermotherapy (TUMT) treatment after an initial period of catheterization. Based on the study results, the FDA indicates “the device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for BPH and after initial post-treatment catheterization.”

NOTE: This policy does not address the use of permanent prostatic stents. The Urolume is an example of an FDA-approved permanent prostatic stent. This wire mesh device is placed into the urethra, where it is slowly incorporated into the urethral wall. This policy only addresses temporary stents, which are designed to be removable.

POSITION STATEMENT:

Use of a temporary prostatic stent is considered experimental or investigational for all indications and specifically for benign prostatic hypertrophy as there is insufficient evidence in the peer-reviewed medical literature that permits conclusions on the effect of using the temporary prostatic stent on health outcomes nor does the evidence demonstrate an improvement in net health outcome through the use of a temporary prostatic stent.

BILLING/CODING INFORMATION:

CPT Coding

ICD-9 Diagnoses Codes That Support Medical Necessity

All diagnoses for use of temporary prostatic stents are considered experimental or investigational.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/26/09.

GUIDELINE UPDATE INFORMATION:

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2010, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2010 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® is a trademark of the American Medical Association.

Date Printed: February 9, 2010: 06:18 AM