SURG 00028 - Surgery for Benign Prostatic Hypertrophy (BPH)

Medical Policy Subject: Surgery for Benign Prostatic Hypertrophy (BPH) Policy #: SURG.00028 Current Effective Date: 11/17/2006 Status: Reviewed Last Review Date: 03/23/2006 Description/Scope Multiple procedures have been developed to treat benign prostatic hypertrophy (BPH). This policy addresses
various surgical procedures used for treatment of BPH, including laser-based procedures, and temporary prostatic
stents.
Policy Statement Medically Necessary: The following surgical procedures are considered medically necessary as an alternative to open prostatectomy or
transurethral resection of the prostate (TURP) for the treatment of benign prostatic hypertrophy (BPH) and include: 1. Laser-based procedures for lasers that have received FDA approval including, but not limited to, the
following:
• Transurethral ultrasound guided laser induced prostatectomy (TULIP) • Contact laser ablation of the prostate (CLAP) • Interstitial laser coagulation of the prostate (ILCP) • Visually guided laser ablation of the prostate (VLAP) • Holmium laser resection of the prostate (HoLRP) 2. Transurethral incision of the prostate (TUIP) 3. Transurethral vapor resection of the prostate (TUVRP), also known as Electrovaporization of the prostate 4. Transurethral radiofrequency needle ablation (RFNA), also known as transurethral needle ablation (TUNA) 5. Transurethral microwave thermotherapy (TUMT) Water induced thermotherapy (WIT), also known as thermourethral hot-water, is considered medically necessary
as a non-surgical treatment for BPH. Not Medically Necessary: Endoscopic balloon dilatation of the prostatic urethra is considered not medically necessary for the treatment of
BPH in all situations. Investigational/Not Medically Necessary: Ultrasound ablation used in the treatment of prostatic hypertrophy is considered investigational/not medically
necessary in all applications. Cryosurgical ablation of the prostate is considered investigational/not medically necessary for the treatment of
BPH in all situations. Placement of temporary prostatic stents is considered investigational/not medically necessary for all uses,
including, but not limited to BPH, following surgical treatment of BPH, prostate cancer, or radiation therapy. The following prostatectomy procedures are considered investigational/not medically necessary for all
applications other than BPH: 1. Contact laser vaporization of the prostate (CLAP) 2. Interstitial laser coagulation of the prostate (ILCP) 3. Visually guided laser ablation of the prostate (VLAP) 4. Transurethral ultrasound guided laser induced prostatectomy (TULIP) 5. Holmium laser resection of the prostate (HoLRP) 6. Transurethral radiofrequency needle ablation (RFNA), also known as transurethral needle ablation (TUNA) 7. Transurethral microwave thermotherapy (TUMT) 8. Water induced thermotherapy (WIT), also known as thermourethral hot water Rationale Laser prostatectomy, transurethral radiofrequency needle ablation (RFNA/TUNA), and electrovaporization of the
prostate have been established as useful and alternative procedures for transurethral resection of the prostate
(TURP). Evidence published in the peer-reviewed medical literature suggests that these procedures can provide
improvement in benign prostatic hypertrophy (BPH) symptoms, voiding function, and urinary retention. In general,
the evidence suggests that non-contact, contact, and hybrid laser ablation techniques are effective for patients with a
prostate size less than 50 grams and may be appropriate for patients who have bleeding disorders or are receiving
anticoagulation therapy. The available evidence suggests that holmium laser enucleation of the prostate (HoLRP) can be used on larger
prostates, although patients with prostate size greater than 75 to 100 grams may require TURP or open
prostatectomy. Both of these procedures have been demonstrated in numerous studies to provide significant relief
of urinary retention due to BPH. Additionally, there is good evidence that water induced thermotherapy (WIT)
appears to be an effective alternative to TURP in men over the age of 50 with prostate lengths between 2.0 cm and
6.4 cm who present with symptoms of urinary outflow obstruction secondary to BPH. The evidence has suggested
that WIT provides significant and sustained improvement in urinary flow. Although there is no data directly comparing WIT with either TURP or other non-surgical therapies (e.g.,
microwave therapy/TUMT, laser prostatectomy), WIT has been shown to relieve the symptoms of BPH without
problems sometimes associated with TURP such as blood loss, incontinence and impotence. The efficacy of these
technologies in individuals with prostatic conditions other than BPH has not yet been established. The level of
evidence supporting the use of the technologies mentioned above for conditions other than BPH is insufficient to
draw conclusions regarding safety and efficacy. Further studies are needed before they can be considered a
standard method of treatment for any condition other than BPH. The evidence published in the peer-reviewed medical literature also suggests that transurethral microwave
thermotherapy (TUMT) is an effective alternative treatment for TURP for patients who have prostatic lengths of
35-50mm. Several studies have demonstrated that TUMT has similar efficacy as TURP in symptom relief, and
patient satisfaction. However, due to the unexpected procedure related complications identified in a letter from the
FDA in 2000, TUMT should be used with caution. The level of evidence supporting this conclusion rises to
include properly randomized controlled trials. The use of temporary prostatic stents has been proposed for the treatment of urinary obstruction due to BPH, and
following surgical treatment of BPH and prostate cancer, or following radiation therapy. At this time, there are no
FDA approved temporary prostatic stents. However, the Spanner™ Temporary Prostatic Stent produced by
Abbeymoore Medical, Inc., is currently under investigation as part of the FDA approval process. At this time, there
are only two articles published in the peer-reviewed medical literature. Both of these articles were case series
studies with very small study populations (5 and 30 patients each). While the results of both of these studies were
favorable, these results alone are insufficient to demonstrate the safety and efficacy of these devices in the general
population. The level of evidence regarding the safety and utility of endoscopic balloon dilatation, cryosurgical ablation, and
ultrasound for the treatment of prostatic hypertrophy is insufficient to draw any conclusions and further studies are
needed before their role in the routine management of men with BPH can be determined.
Background/Overview Description of Disease Benign prostatic hypertrophy (BPH) is a disorder caused by the over-growth of the prostate gland, which then
interferes with the function of the bladder and urethra. This condition usually results in the increased frequency of urination, frequent nighttime urination (nocturia), urinary hesitancy and urgency, and weak urinary stream. These
symptoms typically appear slowly and progress gradually over years. BPH is relatively rare in younger men,
affecting about 8% of men age 31 to 40 years. The incidence of BPH increases with age occurring in
approximately 40-50% of men aged 51 to 60 years and over 80% of men older than age 80 years. Unless a man
with BPH demonstrates symptoms that interfere with his quality of life and cannot be controlled with medical
therapy, surgical intervention is rarely indicated. Description of Technology Treatments for BPH may be both surgical and non–surgical. Conservative non-surgical treatment includes the use
of drugs to shrink the size of the prostate gland. Several drugs are currently in use and have been found to work
well in many cases. Invasive non-surgical treatments for BPH also include water-induced thermotherapy (WIT)
and prostate stents. WIT involves a balloon catheter filled with circulating hot water to apply heat to the prostate,
which destroys prostate tissue allowing the obstructed urethra canal to reopen. Prostatic stenting involves
placement of a metal mesh tube into the urethra where it passes through the prostate. Once set in the proper
location, the stent is expanded to press the urethral wall outward to prevent blockage by the prostate. As previously indicated, there are several different surgical approaches available to treat BPH. The oldest form of
surgical treatment includes open prostatectomy, either approaching the surgical site through the abdomen or
through the perineum. However, this approach has been associated with significant morbidity and long hospital
stays and is currently reserved for treating prostates greater than 100 grams. Transurethral resection of the prostate
(TURP) has been the preferred treatment modality for men with BPH for many years and it remains the standard
against which other treatments are compared. During this procedure surgical equipment is inserted into the urethra
and guided to the area where the prostate constricts the urethral canal. Using a cutting tool, prostate tissue is
excised leaving a cleared canal and a less massive prostate. The high rate of serious complications associated with
TURP, along with the high prevalence of BPH, has encouraged development of alternative surgical treatments.
Newer transurethral surgical treatments are designed as an alternative to long-term medical therapy, but with the
potential benefits of shorter hospital length of stay, and more rapid recovery when compared to TURP. The newer
surgical approaches include laser therapy, transurethral electrovaporization, microwave therapy, and transurethral
needle ablation. In all of these procedures prostate tissue is removed through a heating method that destroys the
desired amount of tissue which is then either reabsorbed by the body or expelled during urination. Following these
procedures, as with TURP, a temporary catheter (tube) is left in the urethra to keep the urinary canal open while the
surgical site heals. The catheter is then removed during a follow-up visit a few days after the surgery. Although the use of microwave thermotherapy for the treatment of BPH with symptoms of urinary obstruction has
been demonstrated to be safe and effective, and more than 25,000 procedures have been performed, the U.S. Food
and Drug Administration (FDA) has identified some unexpected procedure-related complications that have
occurred since the initial marketing of these devices. The FDA has provided a notice and clinical guidance
regarding this issue, which is available on the FDA’s Center for Devices and Radiological Health (CDRH) website
at: http://www.fda.gov/cdrh/safety/bph.html. Proposed Benefits The proposed benefits of any treatment of BPH is to improve voiding and prevent urinary retention, decrease the
frequency of nighttime urination, and debulking of the enlarged gland to decrease discomfort and other symptoms.
Additionally, transurethral approach may result in less blood loss and allow the procedure to done on an outpatient
basis. Possible Risks There are many potential risks involved with these procedures, including the customary risks associated with
anesthesia. For transurethral approaches, risks also include excessive bleeding, bladder neck contracture, infection,
scarring, incontinence, and ejaculatory problems. The risks associated with urethral stent placement include
infection, urethra stone formation, scarring and difficulty in removing the stent if needed. Definitions Ablation: removal or excision Benign prostate hyperplasia (BPH): a condition that causes an increase in the size of the prostate gland in men,
commonly causing urinary retention Balloon dilatation of the prostate: a procedure proposed to relieve urinary retention due to BPH; during this
procedure a flexible balloon catheter is placed in the urethra and moved up to the prostate; the balloon is then
inflated for a short period of time to expand the urethra in this area Cryosurgical: treatment performed with an instrument that freezes and destroys abnormal tissue Electrovaporization of the prostate: a procedure that uses electrical energy to vaporize prostate tissues

Hyperplasia: enlargement of an organ or tissue because of an increase in the number of cells in that organ or tissue

Hypertrophy: the enlargement or overgrowth of an organ or tissue due to an increase in size of its cells, rather than
the number Laser prostatectomy: a therapy that uses laser-generated heat to remove prostate tissue obstructing the urethra.
There are several types of laser techniques currently in use including: non-contact visual laser ablation of the
prostate (VLAP), contact laser vaporization of the prostate (CLAP), hybrid laser ablation of the prostate
(combination of VLAP and CLAP), Interstitial laser coagulation of the prostate (ILCP), transurethral ultrasound-
guided laser-induced prostatectomy (TULIP) and holmium laser resection of the prostate (HoLRP). Stent: a tube made of metal or plastic that is inserted into a vessel or passage to keep the lumen open and prevent
closure due to a stricture or external compression Transurethral microwave thermotherapy (TUMT): a treatment that uses microwave energy to heat and shrink
the prostate to provide relief of urinary obstruction due to BPH Transurethral radiofrequency needle ablation (RFNA): a non-surgical procedure in which low-level
radiofrequency energy is delivered through a needle to a small area of the prostate, with the goal of relieving
symptoms associated with BPH. It is also known as transurethral needle ablation (TUNA). Transurethral needle ablation (TUNA): see transurethral radiofrequency needle ablation (RFNA) above Transurethral: a surgical approach to prostate surgery that involves the insertion of surgical tools through the
urethra instead of through an incision in the skin

Ultrasound for the treatment of prostatic hypertrophy: this procedure proposes to shrink prostate tissue using
sound waves to heat target areas Water-induced thermotherapy (WIT): a non-surgical approach to the treatment of benign prostatic hypertrophy
that involves the use of very hot water to shrink prostate tissue
Coding The following codes for treatments and procedures applicable to this policy are included below for informational
purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member
coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of
service to determine coverage or non-coverage of these services as it applies to an individual member. When services are Medically Necessary:

CPT 52450 Transurethral incision of prostate ICD-9 Diagnosis All diagnoses
When services are also Medically Necessary: CPT 52647 Laser coagulation of prostate, including control of postoperative bleeding,
complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration
and/or dilation, and internal urethrotomy are included if performed) 52648 Laser vaporization of prostate, including control of postoperative bleeding,
complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration
and/or dilation, internal urethrotomy and transurethral resection of prostate are
included if performed) 53850 Transurethral destruction of prostate tissue; by microwave thermotherapy
[TUMT] 53852 Transurethral destruction of prostate tissue; by radiofrequency thermotherapy
[needle ablation, TUNA, RFNA] 53853 Transurethral destruction of prostate tissue: by water-induced thermotherapy
(WIT) ICD-9 Procedure 60.21 Transurethral (ultrasound) guided laser induced prostatectomy (TULIP) 60.96 Transurethral destruction of prostate tissue by microwave thermotherapy 60.97 Other transurethral destruction of prostate tissue by other thermotherapy
ICD-9 Diagnosis 600.00-600.91 Hyperplasia of prostate When services are Investigational/Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses or when the code describes a procedure indicated in
the Policy section as investigational/not medically necessary When services are Not Medically Necessary: CPT 52510 Transurethral balloon dilation of the prostatic urethra ICD-9 Procedure 60.95 Transurethral balloon dilation of the prostatic urethra ICD-9 Diagnosis All diagnoses
Services are Investigational/Not Medically Necessary:

CPT 0084T Insertion of a temporary prostatic urethral stent

ICD-9 Diagnosis All diagnoses
Services are also Investigational/Not Medically Necessary: CPT 55873 Cryosurgical ablation of the prostate (includes ultrasonic guidance
for interstitial cryosurgical probe placement)
ICD-9 Diagnosis 600.00-600.91 Hyperplasia of prostate References Peer Reviewed Publications: 1. Arai Y, Aoko Y, et al. Impact of interventional therapy for benign prostatic hyperplasia on quality of life and
sexual function: a prospective study. J Urol. 2000; 164(4): 1206-1211. 2. Bosch JL. Urodynamic effects of various treatment modalities for BPH. J Urol. 1997; 158(6): 2034-2044. 3. Brookes ST, Donovan JL, Peters TJ, et al. Sexual dysfunction in men after treatment for lower urinary tract
symptoms: evidence from randomised controlled trial. BMJ. 2002; 324(7345): 1059-61. 4. Cabelin MA, Te AE, Kaplan SA. Transurethral vaporization of the prostate: current techniques. Curr Urol Rep.
2000; (2): 116-23. 5. Corica FA, Cheng L, et al. Transurethral hot-water balloon thermoablation for benign prostatic hyperplasia:
patient tolerance and pathologic findings. Urology. 2000; 56(1): 76-80. 6. Corica AP, Larson BT, Sagaz A, et al. A novel temporary prostatic stent for the relief of prostatic urethral
obstruction. BJU Int. 2004; 93(3): 346-8. 7. Donovan JL, Peters TJ, Neal DE, et al. A randomized trial comparing transurethral resection of the prostate,
laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement:
the CLasP study. J Urol. 2000; 164; 65-70. 8. Ekengren J, Haendler, Hahn RG. Clinical outcome 1 year after transurethral vaporization and resection of the
prostate. Urology. 2000; 55:231-235. 9. Gujral S, Abrams P, Donovan JL, et al. A prospective randomized trial comparing transurethral resection of
the prostate and laser therapy in men with chronic urinary retention: the ClasP study. J. Urol. 2000; 164:59-64. 10. Gupta NP, Doddamani D, Aron M, Hemal AK. Vapor resection: a good alternative to standard loop resection
in the management of prostates >40 cc. J Endourol. 2002; 16(10): 767-71. 11. Henderson A, Laing RW, Langley SE. A Spanner in the works: the use of a new temporary urethral stent to
relieve bladder outflow obstruction after prostate brachytherapy. Brachytherapy. 2002; 1(4): 211-8. 12. Kaplan SA, Te AE. A comparative study of transurethral resection of the prostate using a modified electro-
vaporizing loop and transurethral laser vaporization of the prostate. J Urol. 1995; 154(5): 1785-90. 13. Keoghane SR, Lawrence KC, et al. A double-blind randomized controlled trial and economic evaluation of
transurethral resection vs contact laser vaporization for benign prostatic enlargement: a 3-year follow-up. BJU
Int. 2000; 85(1): 74-8. 14. Keoghane SR, Sullivan ME, et al. Five-year data from the oxford laser prostatectomy trial. BJN Int. 2000;
86(3): 227-8. 15. Kupeli S, Yilmaz E, Soygur T, et al. Randomized study of transurethral resection of the prostate and combined
transurethral resection and vaporization of the prostate as a therapeutic alternative in men with benign prostatic
hyperplasia. J Endourology. 2001; 15(3): 317-21. 16. Lukkarinen O, Lehtonen T, Talja M, et al. Finastreride following balloon dilatation of the prostate. A double-
blind, placebo-controlled multicenter study. Annales Chirugiae et Gynacologiae. 1999; 88:299-303. 17. Michel MS, Koehrmann KU, Knoll T, et al. Clinical evaluation of a newly developed endoscopic resection
device (Rotoresect): physical principle and first clinical results. Surg Endosc. 2001; 15(2) 1395-400. 18. Muschter R, Schorsch I, Danielli L, et al. Transurethral water-induced thermotherapy for the treatment of
benign prostatic hyperplasia: a prospective multicenter clinical trial. J Urol. 2000; 164:1565-69. 19. Norby B, Nielsen HV, Drimodt-Moller PC. Transurethral interstitial laser coagulation of the prostate and
transurethral microwave thermotherapy vs. transurethral resection or incision of the prostate: results of a
randomized, controlled study in patients with symptomatic BPH. BJU Int. 2002; 90:853-862. 20. Pace G, Selvaggio O, Palumbo F, Selvaggi FP. Initial experience with a new transurethral microwave
thermotherapy treatment protocol “30-Minute TUMT”. Eur Urology. 2001; 39:405-411. 21. Roehrborn CG, Burkhard FC, Bruskewitz RC, et al. The effects of transurethral needle ablation and resection
of the prostate on pressure flow urodynamic parameters: J Urol. 1999; 162(1). 22. Savoca G, De Stefani S, Gattuccio I, et al. Percutaneous Ethanol Injection of the Prostate as minimally
invasive treatment of benign prostatic hyperplasia: preliminary report. Eur Urol. 2001; 40:504-08. 23. Shingleton WB, Farabaugh P, May W. Three-year follow-up of laser prostatectomy versus transurethral
resection of the prostate in men with benign prostatic hyperplasia. Urology. 2002; 60:305-308. 24. Van Melick HEH, van Venrooij GEPM, Eckhardt MD, Boon TA. A randomized controlled trial comparing
transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign
prostatic hyperplasia: analysis of subjective changes, morbidity and mortality. J Urol. 2003; 169(4): 1411-6. 25. Van Melick HEH, van Venrooij GEPM, Eckhardt MD, Boon TA. A randomized controlled trial comparing
transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign
prostatic hyperplasia: urodynamic effects. J Urol. 2002; 168(3): 1058-62. 26. Wagrell L, Schelin S, Nordling J, et al. Feedback microwave thermotherapy versus TURP for clinical BPH--a
randomized controlled multicenter study. Urology. 2002; 60(2): 292-9. Government Agency, Medical Society, and Other Authoritative Publications: 1. American Urological Association. Guideline on the Management of Benign Prostatic Hyperplasia. 2003. http://www.auanet.org/guidelines/bph.cfm Accessed December 30, 2005. 2. Centers for Medicare and Medicaid Services. National Coverage Determination for Laser Procedures. NCD
#140.5. Effective May 1, 1997. http://www.cms.hhs.gov . Accessed on October 25, 2005. 3. Hayes Medical Technology Directory. Laser Prostatectomy for Benign Prostatic Hyperplasia. Winifred S
Hayes, Inc. Lansdale Pa. June 17, 2002. Updated July 27, 2005. 4. Hayes Medical Technology Directory. Transurethral Microwave Thermography. Winifred S Hayes, Inc.
Lansdale Pa. July 19, 2000. Updated September 1, 2005. 5. Hayes Medical Technology Directory. Transurethral Needle Ablation Therapy. Winifred S Hayes, Inc.
Lansdale Pa. July 9, 2001. Updated October 3, 2005. 6. United States Food and Drug Administration. FDA Public Health Notification: Serious Injuries from
Microwave Thermotherapy for Benign Prostatic Hyperplasia. October 11, 2000. http://www.fda.gov/cdrh/safety/bph.html Accessed December 30, 2005.
Web Sites for Additional Information 1. National Library of Medicine Encyclopedia: Benign Prostatic Hypertrophy http://www.nlm.nih.gov/medlineplus/ency/article/000381.htm . Accessed December 30, 2005. Index Balloon Dilatation of Prostate
Benign Prostatic Hypertrophy
Contact Laser Ablation of the Prostate - CLAP
Cryosurgical Ablation
Electrosurgical Generator System
Electrovaporization
Holmium Laser Resection of the Prostate- HoLRP
Hyperthermia Therapy
Interstitial Laser Coagulation of the Prostate - ILCP
Laser Prostatectomy
Microwave Therapy
Prostalase™
Prostasoft
Prostate Surgery
Prostatron
Spanner™ Temporary Prostatic Stent
Thermoflex
Transurethral Dilatation of the Prostate
Transurethral Hot-Water Balloon Thermoablation
Transurethral Microwave Thermotherapy - TUMT
Transurethral Needle Ablation – TUNA
Transurethral Radiofrequency Needle Ablation – RFNA
Transurethral Vapor Resection of the Prostate (TUVRP)
Ultrasound for Treatment of Prostatic Hypertrophy
Visually Guided Laser Ablation of the Prostate - VLAP
Water-Induced Thermotherapy – WIT Policy History
Status Date Action Reviewed 03/23/2006 Medical Policy & Technology Assessment Committee (MPTAC) annual review.
Updated references. Published on web 04/18/2006. Reviewed 01/01/2006 Updated coding section with 01/01/2006 CPT/HCPCS changes 11/18/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) –
National Coverage Determination (NCD). Revised 04/28/2005 MPTAC review. Revision based on Policy Harmonization: Pre-merger Anthem
and Pre-merger WellPoint. Pre-Merger Organizations Last Review Date Policy
Number Title Anthem, Inc.
01/13/2005 SURG.00028 Surgery for Benign Prostatic
Hypertrophy (BPH) WellPoint Health Networks,
Inc. 12/02/2004 3.08.02 Treatment of Benign Prostatic
Hypertrophy 12/02/2004 3.08.05 Temporary Prostatic Stent
Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and
must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used.
Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly
evolving, and we reserve the right to review and update Medical Policy periodically.

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