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Date Printed: June 25, 2017: 01:19 PM

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This medical policy (medical coverage guideline) is Copyright 2017, 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 2017 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. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-54000-21

Original Effective Date: 03/15/05

Reviewed: 04/27/17

Revised: 05/15/17

Subject: Temporary Prostatic Stent and Prostatic Urethral Lift

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.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

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.

Temporary Prostatic Stent: Intraprostatic stenting has been investigated as a short- term treatment option permitting voluntary urination as an alternative to an indwelling catheter. The U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for The Spanner™ (Abbeymoore Medical Inc.) December 2006. The Spanner The device is inserted under topical anesthesia and 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.

Prostatic Urethral Lift: The prostatic urethral lift procedure involves placement of 1 or more implants in the lateral lobes of the prostate using a transurethral delivery device. The implant device is designed to retract the prostate to allow expansion of the prostatic urethra. The implants are retained in the prostate to maintain an expanded urethral lumen. One device, the NeoTract UroLift System, has been cleared for marketing by the FDA. The device has 2 main components: the delivery device and the implant. Each delivery device comes preloaded with 1 UroLift implant.

POSITION STATEMENT:

Use of a temporary prostatic stent is considered experimental or investigational for all indications. There is insufficient clinical data in peer-reviewed medical literature to permit conclusions on safety, efficacy and net health outcomes.

Prostatic urethral lift (UroLift®) is considered experimental or investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding

52441

Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant (Investigational)

52442

Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure) (Investigational)

53855

Insertion of a temporary prostatic urethral stent, including urethral measurement (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.

Medicare Advantage products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Prostatic Urethral Lift (PUL) (L36775) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Other names or key words used to report temporary prostatic stent:

Spanner™ Temporary Prostatic Stent
Memokath® 028SW Urethral Stent
Prostatic Stent, Temporary

Other names or key words used to report prostatic urethral lift:

Implantable transprostatic tissue retractor system |
NeoTract UroLift®
Transprostatic implant system
UroLift® System
UroLift® transprostatic implant

REFERENCES:

  1. American Urological Association, AUA Guideline on the Management of Benign Prostatic Hyperplasia: Diagnosis and Treatment Recommendations, accessed at auanet.org 02/25/16.
  2. Barkin J, Giddens J, et al, UroLift system for relief of prostate obstruction under local anesthesia. Can J Urol. 2012 Apr;19(2):6217-22.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual, 7.01.151 Prostatic Urethral Lift, 08/16.
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual, Temporary Prostatic Stent (2.01.70), 09/12 (archived).
  5. Cantwell AL, Bogache WK, et al, Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. BJU Int. 2014 Apr;113(4):615-22.
  6. Chin PT, Bolton DM, et al, Prostatic urethral lift: two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology. 2012 Jan;79(1):5-11.
  7. ClinicalTrials.gov, The Effect of Prostatic Urethral Lift Versus Prostate Arterial Embolization on Quality of Life in Men With Urinary Symptoms Secondary to Benign Prostate Hyperplasia (BPH): A Prospective, Single Center, Comparative Trial, sponsored by St. Louis University, accessed 03/07/17.
  8. ClinicalTrials.gov, Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate, sponsored by ProstaPlant Urology System, Ltd., accessed 12/10/10.
  9. ClinicalTrials.gov, The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS, sponsored by Princess Al-Johara Al-Ibrahim Cancer Research Center, accessed 07/29/13.
  10. ClinicalTrials.gov, Prophylactic Urethral Stenting with Memokath After Prostate Implantation for Prostate Adenocarcinoma, sponsored by The Cleveland Clinic, accessed 08/24/11.
  11. ClinicalTrials.gov, The Spanner Prostatic Stent and Patient's Quality of Life (SpannerQoL), sponsored by Princess Al-Johara Al-Ibrahim Cancer Research Center, accessed 06/12/14.
  12. ClinicalTrials.gov, Study of Median Lobe Prostatic UroLift Procedure, sponsored by NeoTract, Inc. Accessed 02/25/16.
  13. ClinicalTrials.gov, Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments, sponsored by SRS Medical, accessed 03/07/17.
  14. Dineen MK, Shore ND, Lumerman JH, et al, Use of a Temporary Prostatic Stent After Transurethral Microwave Thermotherapy Reduced Voiding Symptoms and Bother Without Exacerbating Irritative Symptoms, Urology, 2008 May; 71(5): 873-7.
  15. First Coast Service Options, Inc. (FCSO), LCD for Prostatic Urethral Lift (PUL) (L36775), 10/31/16.
  16. Goh M, Kastner C, et al, First Experiences with the Spanner™ Temporary Prostatic Stent for Prostatic Urethral Obstruction, Urol Int. 2013;91(4):384-90.
  17. Gratzke C, Barber N, et al, Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJU Int. 2016 Nov 14. doi: 10.1111/bju.13714.
  18. Grimsley SJ, Khan, MH, Lennox E, Paterson PH, Experience with the Spanner Prostatic Stent in Patients Unfit for Surgery: An Observational Study, Journal of Endourology, 09/01/07, 21(9): 1093-1096.
  19. McKenzie P, Badlani G, Critical Appraisal of the Spanner™ Prostatic Stent in the Treatment of Prostatic Obstruction, Medical Devices: Evidence and Research, 2011:4 27-33.
  20. McNicholas TA, Benign prostatic hyperplasia and new treatment options - a critical appraisal of the UroLift system. Med Devices (Auckl). 2016 May 19;9:115-23.
  21. McNicholas TA, Woo HH, et al, Minimally invasive prostatic urethral lift: surgical technique and multinational experience. Eur Urol. 2013 Aug;64(2):292-9.
  22. McVary KT, Gange SN, et al, Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. 2014 Jan;11(1):279-87.
  23. National Institute for Health and Clinical Excellence (NICE). Interventional procedure guidance 475. Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. January 2014. Accessed at nice.org.uk 02/25/16.
  24. National Institute for Health and Clinical Excellence (NICE): UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia; NICE medical technology guidance [MTG26] Published date: September 2015. Accessed at nice.org.uk 02/25/16.
  25. Ray A, Morgan H, et al, The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2016 Oct;14(5):515-26.
  26. Roehrborn, CG, Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Clin North Am. 2016 Aug;43(3):357-69.
  27. Roehrborn CG, et al, Three Year Results of the Prostatic Urethral L.I.F.T Study, Can J Urol. 2015 Jun;22(3):7772-82.
  28. Roehrborn CG, Gange SN, et al, Durability of the prostatic urethral lift: two year results of the L.I.F.T. Study. Urology Practice 2015 (2); 1-7.
  29. Roehrborn CG, Gange SN, et al, The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol. 2013 Dec;190(6):2161-7.
  30. Shore N, A Review of the Prostatic Urethral Lift for Lower Urinary Tract Symptoms: Symptom Relief, Flow Improvement, and Preservation of Sexual Function in Men With Benign Prostatic Hyperplasia. Curr Bladder Dysfunct Rep; published online: 27 March 2015.
  31. Shore N, Freedman S, et al, Prospective multi-center study elucidating patient experience after prostatic urethral lift. Can J Urol. 2014 Feb.
  32. Sønksen J, Barber NJ, et al, Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate: 12-month Results from the BPH6 Study. European Urology (2015); http://dx.doi.org/10.1016/j.eururo.2015.04.024.
  33. Tabatabaei S, et al, Office Evaluation of Male Patients with Lower Urinary Tract Symptoms, Curr Urol Rep. 2012 Dec;13(6):474-81.
  34. U.S. Food and Drug Administration (FDA), Medical Devices, The Spanner™ Temporary Prostatic Stent- Summary of Safety and Effectiveness Data, accessed at fda.gov 06/11/14.
  35. U.S. Food and Drug Administration (FDA), NeoTract® UroLift® System 510 Premarket notification, accessed at fda.gov 03/26/15.
  36. Woo HH, Bolton DM, et al, Preservation of sexual function with the prostatic urethral lift: a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med. 2012 Feb;9(2):568-75.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/27/17.

GUIDELINE UPDATE INFORMATION:

03/15/05

New Medical Coverage Guideline.

03/15/06

Annual review: continue investigational.

02/15/07

Scheduled review. No change in investigational status. Revised when services are covered; add “of temporary prostatic stent”. Added “temporary prostatic” to Billing/Coding Information section-ICD-9 diagnoses codes that support medical necessity. Updated references.

06/15/07

Reformatted guideline; references updated.

03/15/08

Annual review: position statement maintained, description section updated, references updated.

03/15/09

Annual review: position statement maintained and references updated.

01/01/10

Annual HCPCS coding update: added code 53855, deleted code 0084T.

03/15/10

Annual review: position statement maintained; description section and references updated.

02/15/11

Annual review: position statement maintained and references updated.

10/15/11

Scheduled review; position statement maintained, description section and references updated.

11/15/12

Annual review; position statement maintained and references updated.

09/15/13

Annual review; investigational position statement maintained and references updated.

08/15/14

Annual review; position statement maintained and references updated.

06/15/15

Annual review; position statement, billing/coding, description, guideline title and references updated.

04/15/16

Revision; position statements maintained and references updated

05/15/17

Revision; Investigational position statements maintained; description and references updated.

Date Printed: June 25, 2017: 01:19 PM