Minimally Invasive Treatments for Benign Prostatic Hyperplasis (BPH) Form

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Medical Policy Number: 7.01.VT151

Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) Corporate Medical Policy

File Name: Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) File Code: 7.01.VT151 Origination: 05/2018 Last Review: 10/2025 Next Review: 10/2026 Effective Date: 02/01/2026 & 01/01/2026 (Adaptive Maintenance Review)

Description/Summary

Benign prostatic hyperplasia (BPH) is a common condition in older individuals. Other names for benign prostatic hyperplasia (BPH) include benign prostatic hypertrophy, an enlarged prostate, and BPH. Approximately 8 percent of individuals with prostates aged 31 to 40 have BPH. In people over age 80, more than 80 percent have BPH. Many people with BPH have no symptoms. In people with symptoms, the most common include needing to urinate frequently (during the day and night), a weak urine stream, and leaking or dribbling of urine. These symptoms are called lower urinary tract symptoms (LUTS). For people with bothersome symptoms, treatment with one or more medicines or surgery is available.

The prostatic urethral lift procedure involves the insertion of one or more permanent implants into the prostate, which retract prostatic tissue and maintain an expanded urethral lumen, hence increasing the size of the urethral opening and reducing obstruction to urine flow.

Rezūm™ water vapor thermal therapy delivers a heated stream of water vaporizing to prostate tissue and immediately reducing symptoms.

Transurethral water vapor thermal therapy and transurethral waterjet ablation (aquablation) procedure that utilizes water vapor thermal therapy uses radiofrequency- generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective versus conductive heat transfer to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.

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Medical Policy Number: 7.01.VT151

Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I

When a service may be considered medically necessary

Prostatic Urethral Lift

1. For members with a diagnosis of moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia, prostatic urethral lift may be considered medically necessary when ALL the following criteria are met:

   a. Age 45 years of age or older; AND b. Estimated prostate volume <= 100cc by radiologic studies, or by digital rectal exam and/or cystoscopy if obvious or if radiology studies are not possible (may be confirmed with transrectal ultrasound); AND c. Prostate anatomy demonstrates normal bladder neck without an obstructive median lobe; AND d. Contraindication to, intolerance of, or failure of at least three months of standard medical therapy for BPH (i.e. alpha blocker, 5α-reductase inhibitor, phosphodiesterase-5 (PDE5) inhibitor); AND e. A diagnosis of urinary obstruction either by a clear clinical history, cystoscopy, urodynamics, or a peak urine flow rate (Qmax) less than 15 cc/sec on a voided volume that is greater than 125 cc; AND f. If a prostate specific antigen (PSA) is indicated in an individual with a diagnosis of LUTS and BPH with the PSA level meeting the following criteria: i. Taken within 12 months of the procedure; AND ii. Resulted in a value of 4.0 ng/mL or less, or age adjusted level; OR iii. Has had at least one negative biopsy if the PSA is elevated for age

2. For members with a diagnosis of moderate-to-severe lower urinary tract obstruction with a history of or current prostate cancer prostatic urethral lift may be considered medically necessary when ONE of the following criteria are met:

   a. The individual is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required; OR b. The individual is clinically in remission and satisfies medical criteria b, c & e above; OR c. The individual is on active surveillance for low or very low risk prostate cancer; AND satisfies medical criteria b, c & e above.

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Medical Policy Number: 7.01.VT151

Transurethral Water Vapor Thermal Therapy (Rezūm™) and Waterjet Tissue Ablation

Transurethral Water Vapor Thermal Therapy (Rezūm™) and Waterjet Tisue Ablation (for example Aquablation®)in patients 45 and older with or without obstructed median lobe, may be considered medically necessary for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia as an alternative to Transurethral resection of the prostate (TURP) or open prostatectomy when all of the following criteria are met:

1. Patient is not an appropriate candidate for an invasive surgical procedure using general anesthesia such as transurethral resection of the prostate due to underlying disease (e.g., cardiac disease, pulmonary disease, etc.), or at high risk of bleeding; OR
2. The patient opts to undergo a minimally invasive procedure; AND
3. Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy for BPH, after an appropriate trial period, defined as one month following an alpha-1-adrenergic antagonist or 3 months following a 5- alphareductase inhibitor, or intolerance or other contraindication to medical therapy; AND
4. Estimated prostate volume <= 80cc by radiologic studies, or by digital rectal exam and/or cystoscopy if obvious or if radiology studies are not possible (may be confirmed with transrectal ultrasound); AND
5. The patient is 45 years of age or older; AND
6. The device system is used by a physician trained in the specialty of Urology; AND
7. Patient does not have an active urinary tract infection or prostatitis within past year; AND

8. Patient has had appropriate testing to exclude diagnosis of prostate cancer.

   When a service is considered investigational

   Prostatic urethral lift (i.e., UroLift) and transurethral water vapor thermal therapy (i.e. Rezūm™) and water tissue ablation are considered investigational for all other indications including repeat procedure.

   Reference Resources

9. Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. Jul19 2012;367(3):248-257. PMID 22808960
10. Barry MJ, Fowler FJ, Jr., O'Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. Nov 1992;148(5):1549-1557; discussion
11. PMID 1279218
12. O'Leary M P. Validity of the "bother score" in the evaluation and treatment of symptomatic benign prostatic hyperplasia. Rev Urol. Winter 2005;7(1):1-10. PMID 16985801
13. (AUA) AUA. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). 2010;

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https://www.auanet.org/common/pdf/education/clinical- guidance/Benign- Prostatic-Hyperplasia.pdf. Accessed November 25, 2017.

5. Reich O, Gratzke C, Bachmann A, et al. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. Jul 2008;180(1):246-249. PMID 18499179
6. Rosen RC, Catania JA, Althof SE, et al. Development and validation of four- item version of Male Sexual Health Questionnaire to assess ejaculatory dysfunction. Urology. May 2007;69(5):805-809. PMID 17482908
7. Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): a 5-year review of research and clinical experience. Int J Impot Res. Jul-Aug 2005;17(4):307-319. PMID 15875061
8. Barry MJ, Williford WO, Chang Y, et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. Nov 1995;154(5):1770-1774. PMID 7563343
9. Barry MJ, Fowler FJ, Jr., O'Leary MP, et al. Measuring disease -specific health status in men with benign prostatic hyperplasia. Measurement Committee of The American Urological Association. Med Care. Apr 1995;33(4 Suppl):AS145-155. PMID 7536866
10. Perera M, Roberts MJ, Doi SA, et al. Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systematic review and meta-analysis. Eur Urol. Apr 2015;67(4):704-
11. PMID 25466940
12. Garrido Abad P, Coloma Del Peso A, Sinues Ojas B, et al. Urolift(R), a new minimally invasive treatment for patients with low urinary tract symptoms secondary to BPH. Preliminary results. Arch Esp Urol. Jul-Aug 2013;66(6):584-
13. PMID 23985459
14. Hoffman RM, Monga M, Elliott SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2012;9:CD004135. PMID 22972068
15. Shore N, Freedman S, Gange S, et al. Prospective multi-center study elucidating patient experience after prostatic urethral lift. Can J Urol. Feb 2014;21(1):7094-
16. PMID 24529008
17. McNicholas TA, Woo HH, Chin PT, et al. Minimally invasive prostatic urethral lift: surgical technique and multinational experience. Eur Urol. Aug 2013;64(2):292-299. PMID 23357348
18. Chin PT, Bolton DM, Jack G, et al. Prostatic urethral lift: two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology. Jan 2012;79(1):5-11. PMID 22202539
19. Woo HH, Bolton DM, Laborde E, 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. Feb 2012;9(2):568-575. PMID 22172161
20. Woo HH, Chin PT, McNicholas TA, et al. Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. Jul 2011;108(1):82-
21. PMID 21554526
22. Cantwell AL, Bogache WK, Richardson SF, et al. Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms

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secondary to benign prostatic hyperplasia. BJU Int. Apr 2014;113(4):615-622. PMID 24765680

19. Roehrborn CG, Gange SN, Shore ND, 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. Dec 2013;190(6):2161-
20. PMID 23764081
21. McVary KT, Gange SN, Shore ND, et al. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. Jan 2014;11(1):279-287. PMID 24119101
22. Jones P, Rajkumar GN, Rai BP, et al. Medium-term outcomes of Urolift (minimum 12 months follow-up): evidence from a systematic review. Urology. May 18 2016. PMID 27208817
23. Bozkurt A, Karabakan M, Keskin E, et al. Prostatic urethral lift: a new minimally invasive treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urol Int. 2016;96(2):202-206. PMID 26613256
24. Sonksen J, Barber NJ, Speakman MJ, et al. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12- month results from the BPH6 study. Eur Urol. Oct 2015;68(4):643-652. PMID 25937539
25. Ray A, Morgan H, Wilkes A, 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. Jan 30 2016. PMID 26832146
26. Roehrborn CG, Rukstalis DB, Barkin J, et al. Three-year results of the prostatic urethral L.I.F.T. study. Can J Urol. Jun 2015;22(3):7772-7782. PMID 26068624
27. 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. Aug 2016;43(3):357-369. PMID 27476128
28. National Institute for Health and Care Excellence (NICE). Nice Interventional Procedural Guidance IPG475: Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. 2014; http://www.nice.org.uk/guidance/ipg475/chapter/1-recommendations. Accessed November 25, 2017.
29. Blue Cross and Blue Shield Medical Policy Reference Manual (MPRM). Prostatic Urethral Lift. MPRM 7.01.151. Last reviewed September 2025. Accessed October 2025.
30. Blue Cross and Blue Shield Medical Policy Reference Manual (MPRM). Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy. MPRM 2.01.49. Last reviewed July 2025. Accessed October 2025.
31. McVary, K.T., Gange, S.N., Gittelman, M.C., et al. Minimally invasive prostate convection water vapor energy ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. May 2016. 195(5). 1529-1538.
32. McVary, KT, Rogers, T, Roehrborn CG, Rezum water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from a randomized controlled study. Urology 2019; 126:171-179.
33. American Urological Association. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019). [https://www.auanet.org/guidelines/benign-prostatichyperplasia-(bph)-

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guideline] accessed 5/21/21.

33. Darson MF, et al. Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezūm system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Res Rep Urol 2017 Aug 21;9: 159-168.
34. Dixon CM, et al. Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezūm(®) system: evaluation of acute ablative capabilities in the human prostate. Res Rep Urol 2015 Jan 30; 7:13-8.
35. Dixon CM, et al. Efficacy and safety of Rezūm system water vapor treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology 2015 Nov;86(5):1042-7.
36. *Dixon CM, et al. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol 2016 Nov 21;8: 207-216.
37. Gaffney CD, Basourakos SP, Al Hussein Al Awamlh B, et al. Adoption, Safety, and Retreatment Rates of Prostatic Urethral Lift for Benign Prostatic Enlargement. J Urol. Aug 2021; 206(2): 409-415. PMID 33793296
38. Page T, Veeratterapillay R, Keltie K, et al. Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics. BMC Urol. Apr 07 2021; 21(1):
39. PMID 33827525
40. National Institute for Health and Care Excellence (NICE). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia [IPG475]. 2014; https://www.nice.org.uk/guidance/ipg475/chapter/1- recommendations. Accessed July 7, 2022.
41. National Institute for Health and Care Excellence (NICE). UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia [MTG58]. 2021; https://www.nice.org.uk/guidance/MTG58. Accessed July 7, 2022.
42. Lerner LB, McVary KT, Barry MJ, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. Oct 2021; 206(4): 818-826. PMID 34384236
43. National Institute for Health and Care Excellence (2020). Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia. https://www.nice.org.uk/guidance/mtg49/chapter/1-Recommendations. Accessed April 23, 2022.
44. Elterman D, Gilling P, Roehrborn C, et al. Meta-analysis with individual data of functional outcomes following Aquablation for lower urinary tract symptoms due to BPH in various prostate anatomies. BMJ Surg Interv Health Technol. 2021; 3(1): e000090. PMID 35047807.

45. Gilling P, Barber N, Bidair M, et al. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation ® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. J Urol. May 2018; 199(5): 1252-1261. PMID 29360529 Document Precedence

    Blue Cross and Blue Shield of Vermont (Blue Cross VT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The

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Medical Policy Number: 7.01.VT151

applicable group/individual contract and member certificate language, or employer’s benefit plan if an ASO group, determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, Blue Cross VT reserves the right to review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract/employer benefit plan language, the member’s contract/employer benefit plan language takes precedence.

Audit Information

Blue Cross VT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, Blue Cross VT reserves the right to recoup all non- compliant payments. Administrative and Contractual Guidance Benefit Determination Guidance

Prior approval may be required and benefits are subject to all terms, limitations and conditions of the subscriber contract. Incomplete authorization requests may result in a delay of decision pending submission of missing information. To be considered compete, see policy guidelines above.

NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member’s health plan.

Federal Employee Program (FEP): Members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. It is important to verify the member’s benefits prior to providing the service to determine if benefits are available or if there is a specific exclusion in the member’s benefit.

Coverage varies according to the member’s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict.

If the member receives benefits through an Administrative Services Only (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member’s employer benefit plan documents or contact the customer service department. Language in the employer benefit plan documents takes precedence over medical policy when there is a conflict.

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Medical Policy Number: 7.01.VT151

Policy Implementation/Update information

05/2018 New policy, external input received, reviewed BCBSA MPRM 7.01.151, updated references. Codes 52441, 52442, C9739 & C9740 require prior authorization. 01/2019 Updated policy criteria with network provider subject matter expert input. Clarified criteria and age range especially around definition of obstructive uropathy and eliminated PSA requirement for subgroups who would not otherwise require PSA such as elderly patients with BPH and LUTS and known cancer patients. 01/2020 Updated policy language for clarity and after receipt of clinical feedback and review of literature amended prostate volume from 80 to 100ccs. Updated references. 05/2021 Policy statement changed to include medically necessary criteria for Rezūm™ water vapor thermal therapy. References updated. Policy title changed from Prostatic Urethral Lift to Minimally Invasive Treatments for Benign Prostatic Hyperplasia. Added code 53854 to require prior approval. 10/2022 Policy statement changed to include medically necessary criteria for Waterjet tissue ablation for (i.e. Aquablation®). References updated. Added code 0421T as medically necessary if medical policy criteria has been met. Code 0421T removed as investigational. 10/2023 References updated, added waterjet tissue ablation to water vapor as criteria are the same at this time. 12/2023 Adaptive Maintenance Effective 01/01/2024: Added code C2596 as medically necessary to coding table. 12/2024 Policy reviewed. No change to policy statement. Minor formatting changes for clarity and consistency. References updated. 10/2025 Effective 02/01/2026: Policy reviewed. No change to policy statement. References updated. 12/2025 Adaptive Maintenance Effective 01/01/2026: Deleted codes 0421T Added code 52597 to coding table as no prior approval required.

Eligible providers Qualified healthcare professionals practicing within the scope of their license(s). Approved by Blue Cross VT Medical Directors

Tom Weigel, MD, MBA Vice President and Chief Medical Officer

Tammaji P. Kulkarni, MD Senior Medical Director

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Medical Policy Number: 7.01.VT151

Attachment I

Code Type Number Brief Description Policy Instructions The following codes are considered as medically necessary when applicable criteria have been met. CPT® 52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant Requires Prior Approval CPT® 52442 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure) Requires Prior Approval CPT® 52597 Transurethral robotic-assisted waterjet resection of prostate, including intraoperative planning, ultrasound guidance, control of No Prior Approval Required CPT® 53854 Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy Requires Prior Approval HCPCS C2596 Probe, image guided, robotic, waterjet ablation No Prior Approval Required HCPCS C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants Requires Prior Approval HCPCS C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants Requires Prior Approval