Medical Policy


Subject:Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions
Policy #:  SURG.00028Current Effective Date:  04/01/2014
Status:RevisedLast Review Date:  02/13/2014

Description/Scope

Multiple procedures have been developed to treat benign prostatic hyperplasia (BPH). This document addresses various surgical and minimally invasive procedures used in the treatment of BPH, and the use of these procedures for other genitourinary conditions.

Note: Please see the following related documents for additional information:

Position 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 hyperplasia (BPH):

  1. Laser-based procedures that have received U.S. Food and Drug Administration (FDA) approval include, but are not limited to, any of the following:
    • Contact laser ablation of the prostate (CLAP); or
    • Holmium laser procedures, including Holmium laser ablation of the prostate (HoLAP), Holmium laser enucleation of the prostate (HoLEP), and Holmium laser resection of the prostate (HoLRP); or
    • Interstitial laser coagulation of the prostate (ILCP); or
    • Photoselective laser vaporization of the prostate (PVP); or
    • Transurethral ultrasound guided laser induced prostatectomy (TULIP); or
    • Visually guided laser ablation of the prostate (VLAP), also called non-contact laser ablation of the prostate; OR
  2. Transurethral incision of the prostate (TUIP); OR
  3. Transurethral radiofrequency needle ablation (RFNA), also called transurethral needle ablation (TUNA); OR
  4. Transurethral vapor resection of the prostate (TUVRP), also called transurethral electrovaporization of the prostate (TUEVP, TUVAP, or TUEVAP), transurethral evaporation (TUEP), or transurethral vaporization of the prostate (TUVP, TVP).

The following minimally invasive procedures are considered medically necessary as an alternative to open prostatectomy or TURP for the treatment of BPH:

  1. Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy; or
  2. Transurethral microwave thermotherapy (TUMT).

Not Medically Necessary:

Endoscopic balloon dilation of the prostatic urethra for the treatment for BPH is considered not medically necessary. 

Investigational and Not Medically Necessary:

The following procedures are considered investigational and not medically necessary for the treatment of BPH:

  1. Cryosurgical ablation; or
  2. High-intensity focused ultrasound (HIFU) ablation; or
  3. Prostatic arterial embolization; or
  4. Prostatic urethral lift.

Placement of temporary prostatic stents is considered investigational and not medically necessary for all indications including, but not limited to, treatment of BPH, following surgical treatment of BPH, prostate cancer, or radiation therapy.

The following procedures are considered investigational and not medically necessary for all genitourinary conditions other than BPH:

  1. Contact laser ablation of the prostate (CLAP); or
  2. Holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP); or
  3. Interstitial laser coagulation of the prostate (ILCP); or
  4. Photoselective laser vaporization of the prostate (PVP); or
  5. Transurethral microwave thermotherapy (TUMT); or
  6. Transurethral radiofrequency needle ablation (RFNA), also called transurethral needle ablation (TUNA); or
  7. Transurethral ultrasound guided laser induced prostatectomy (TULIP); or
  8. Visually guided laser ablation of the prostate (VLAP), also called non-contact laser ablation of the prostate; or
  9. Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy.
Rationale

Surgical and Minimally Invasive Treatments for BPH

Standard surgical treatments for BPH are some of the most common therapies in medical practice but as a management option are typically performed in the operating room setting, require anesthesia, and may be associated with a greater risk for morbidity. Surgical treatments such as open prostatectomy and TURP may be accompanied by undesirable complications such as blood loss, need for transfusion, and absorption of irrigation fluids. Postoperative side effects may include retrograde ejaculation and incontinence. Surgical techniques have been developed using lasers, as well as minimally invasive techniques using various sources of energy including heat, microwaves, radiofrequency, and ultrasound. There are a number of outcome variables to examine in comparing these surgical and minimally invasive treatments to other major surgical procedures.

According to the American Urological Association (AUA, 2010):

Traditionally, the gold standards have been an open prostatectomy (retropubic, suprapubic) for very large prostates or those with large bladder calculi and a monopolar transurethral resection of the prostate (TURP). For small prostates (less than 30 gm), the option for a transurethral incision of the prostate (TUIP) has been found to be associated with fewer complications but comparable efficacy.

Laser-based prostatectomy procedures including potassium-titanyl-phosphate photovaporization (Al-Ansari, 2010; Araki, 2008; Elmansy, 2010; Rusvat, 2008, Stafinski, 2008, Tugcu, 2008) and other surgical and minimally invasive treatments including TUIP (Riehmann, 1995; Tkocz, 2002), TUMT, RFNA/TUNA (Bouza, 2006; Boyle, 2004; Hill, 2004; Hindley, 2001; Roehrborn, 1999), and TUVP (Ekengren, 2000; Poulakis, 2004; Van Melick, 2002; Van Melick, 2003) have been established as useful and alternative procedures to TURP. Holmium laser procedures including HoLAP (Elmansy, 2010), HoLEP (Ahyai, 2007; Elzayat, 2007; Kuntz, 2008; Shah, 2007; Tan, 2007; Wilson, 2006) and HoLRP (Ruzat, 2008; Westenberg, 2004) have been evaluated in clinical trials and compared with TURP in meta-analyses and systematic reviews. The data in the peer-reviewed medical literature suggests that these procedures may provide improvement in BPH symptoms, voiding function, and urinary retention, in addition to comparing favorably in the long-term to TURP with equally low complication rates. Although there is a lack of data directly comparing WIT with either TURP or other surgical procedures, the safety and efficacy of WIT has been shown to relieve the symptoms of BPH without the occurrence of blood loss, incontinence, and impotence which are sometimes associated with TURP (Breda, 2002; Muschter, 2000). 

TUMT (CoreTherm®, Prostalund® AB, Uppsala, Sweden; Prolieve Thermodilatation® System, Boston Scientific Corp. U.S.A, Natick, MA; Prostatron® and Targis® Systems, Cooled ThermoTherapy™, Urologix®, Minneapolis, MN; TMx-2000™ TherMatrx®, American Medical Systems, Inc., Minnetonka, MN) is an alternative treatment to TURP for BPH (Albala, 2002; Dahlstrand, 1995; Wagrell, 2004). Several randomized controlled and comparative trials have demonstrated that TUMT has similar efficacy as TURP in symptom relief and satisfaction (Albala, 2002; Floratos, 2001; Hoffman, 2012; Kaye, 2008; Miller, 2003; Mynderse, 2011; Norby, 2002; Ohigashi, 2007; Vesely, 2005).

Other Minimally Invasive Treatments for BPH

Prostatic Artery Embolization (PAE)

PAE has been proposed as a treatment for BPH to reduce the blood supply of the prostate gland which results in some of the gland undergoing necrosis with subsequent shrinkage. The procedure is performed with the individual under local anesthetic using a percutaneous transfemoral approach. Embolization is achieved using microparticles (such as gelatin sponge, polyvinyl alcohol [PVA], and other synthetic biocompatible materials) introduced by super-selective catheterization to block small prostatic arteries. Early results from a United States clinical trial evaluate the efficacy and safety of PAE in 20 men with BPH (Bagla, 2014). Following embolization, 19 of 20 participants experienced average AUA symptom score improvements of 10.8 points (p<.0001), 12.1 points (p=.0003) and 9.8 points (p=.007) at 1-, 3-, and 6 months, respectively. Improvements were also reported in quality of life-related symptoms and sexual function. Prostate volume decreased 18% (p=.05) in five individuals at six months. Limitations of this trial include lack of a comparator treatment group, blinding, and randomization, the small sample size, and short-term follow-up of outcome measures.

Pisco and colleagues (2013) conducted two prospective, nonrandomized studies in Portugal evaluating short-, intermediate-, and mid-term outcomes of PAE in men with BPH. The largest study with mid-term results evaluated 255 participants for a mean follow-up period of 10 months (range 1-36 months). All participants were on medical therapy for BPH with persistent moderate to severe symptoms for more than six months. Eight participants had TURP years before and 32 participants had bladder catheters at the time due to acute urinary retention. PAE was reported as "technically successful" in 238 of 250 participants, defined as PAE completed in at least one pelvic side. Clinical success was reported as the mean value over time of response to effectiveness variables including International Prostate Symptom Score (IPSS), quality of life score, International Index Erectile Function (IIEF), uroflowmetry, and prostate specific antigen (PSA) levels and volume. Most clinical changes and success occurred in the first month after PAE in 195 (81.9%) participants with clinical failures in 43 (18.1%) participants. Cumulative rates of clinical success, defined as improving symptoms and quality of life, at 6 and 12 months were 78% and 75%, respectively. A statistically significant improvement over time of all evaluated parameters was observed; however, there was not a relationship between the reduction in prostatic volume and the clinical outcome (p=0.12). An improvement in the mean uroflowmetry obtained after PAE was modest compared to individuals who are treated surgically by TURP, reported as 51% for PAE compared to 125% for TURP. Additional study with long-term follow-up is needed to address the question of longevity of this PAE outcome. There was only one major complication reported (bladder ischemia) and no cases of sexual dysfunction including impotence or retrograde ejaculation. Limitations of this single-center study include lack of randomization, absence of a comparator treatment group, and short-term follow-up of outcome measurements; a potential bias also exists concerning the use of questionnaires to validate subjective outcome measures.

PAE for symptomatic BPH has been assessed in small case series and single-center studies evaluating measures of clinical symptom improvement (Carneval, 2013; Rio Tinto, 2012), laboratory and urodynamic findings (Antunes, 2013), use of different PVA particle sizes (Bilhim, 2013a), clinical outcomes comparing unilateral to bilateral PAE (Bilhim, 2013b), and quality of life measures. Few post-PAE complications were reported in these studies, including urinary tract infection requiring antibiotics and acute post-PAE urinary retention requiring temporary catheterization. Despite some promising preliminary results, including the potential for reduced morbidity and avoidance of general anesthesia, additional multicenter randomized controlled trials with long-term follow-up are needed to evaluate the safety and durability of the clinical benefits of PAE over standard surgical procedures for the treatment of moderate to severe lower urinary tract symptoms (LUTS) secondary to BPH.

A National Institute for Health and Care Excellence (NICE, 2013) interventional procedure guidance for PAE for BPH states:

Current evidence on the safety and efficacy of prostate artery embolization for benign prostatic hyperplasia is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. Further research in the form of randomized trials or cohort studies (for example, using an appropriate register) should clearly document patient selection criteria and all complications, specifically including disturbance of sexual function. Efficacy outcomes should include measure of urinary function, symptoms and quality of life. Information about longer-term outcomes, including the need for further treatment, would be valuable.

The current AUA guidelines and Society of Interventional Radiology (SIR) consensus statements do not address the use of PAE for the treatment of BPH. A SIR Research Consensus Panel (2013) has identified and prioritized the topic for further study in the form of a prospective randomized multicenter clinical study to determine the safety and effectiveness of PAE for BPH versus a sham procedure using IPSS score as the primary endpoint with the secondary objective to evaluate quality of life.

Prostatic Urethral Implant (PUL)

The PUL procedure is a minimally invasive treatment for symptomatic LUTS secondary to BPH. A PUL device is permanently implanted with the individual under local anesthesia and is intended to hold the lateral prostatic lobes apart and create a passage through an obstructed prostatic urethra to improve the voiding channel. The NeoTract UroLift® System (NeoTract Inc., Pleasanton, CA) received FDA 510(k) designation (K130651) on September 13, 2013 as a de novo device indicated for the treatment of men 50 years of age and older with LUTS secondary to BPH.

Chin and colleagues (2012) evaluated the two-year results of the UroLift in an industry-sponsored, prospective, nonrandomized multicenter Australia-based trial of 64 men, ages 55 years or older, with moderate to severe symptomatic BPH. The procedure was performed by transurethral delivery of small PUL implants to secure the prostatic lobes in an open position, thereby reducing the obstruction of the urethral lumen. The implant technique was refined during the course of the study using cystoscopic and symptomatic results from participants treated early in the study. To evaluate effectiveness, a general estimating equation model was adapted to each output parameter, including IPSS, quality of life, BPH Impact Index (BPHII), and peak urethral flow rate assessed at 2 weeks, and 3-, 6-, 12-, and 24 months. In the evaluable participants, IPSS was reduced from the baseline by 42%, 49%, and 42% at 2 weeks, 6 months, and 2 years, respectively. No compromise in sexual function was observed after treatment and the average Sexual Health Inventory for Men (SHIM) questionnaire score at each follow-up interval was slightly increased compared with baseline, although these differences were not statistically significant. The early postoperative course was typical of an endoscopic procedure in terms of irritative symptoms, including dysuria and mild hematuria, which resolved in the first week. Other post-procedure adverse events included epididymo-orchitis (n=1), rigor (n=1), prostatitis (n=1), urinary tract infection (n=7), and myocardial infarction in an individual with a history of heart disease and percutaneous coronary intervention whose anticoagulants were withdrawn before the procedure. Thirty-four of 64 participants (53%) required postoperative catheterization and two participants underwent TURP within 30 days due to lack of response to the PUL. At the end of two-year follow-up, 20% (13 of 64) of participants underwent TURP, PVP, or repeat PUL procedures due to return of LUTS. Limitations of this study include lack of an active or sham control group, limited sample size for some outcome measures, lack of inclusion criteria related to sexual function or sexual activity, limited durability of results for some participants as the device was changed and implant procedural technique refined during the course of the study, and lack of sustained response and return of LUTS in 20% of participants after PUL implant (which required repeat treatment).

Roehrborn and colleagues (2013) reported result of a multicenter prospective trial (L.I.F.T.) of the UroLift System for the treatment of LUTS secondary to BPH. The two-phase study included a randomized single-blinded period, starting at the time of the procedure and ending at the participant's three-month visit, followed by a nonrandomized open-label period. After the three-month follow-up visit, if symptoms returned and treatment was required, participants were allowed to receive treatment with the UroLift System or any other approved BPH treatment. A total of 206 men, ages 50 years or older, with AUA Symptom Index (AUASI) 13 or greater, maximum flow rate 12 milliliters per second or less, and a prostate size of 30 to 89 cubic centimeters were randomized 2:1 between PUL device (n=140) or sham treatment (n=66). The primary efficacy endpoint (intent-to-treat) was demonstration of a reduction in AUASI at least 25% greater than that of sham treatment at three months post-PUL procedure; all participants in the PUL group were followed through one year to evaluate durability of effect. Secondary effectiveness endpoints included measurements in peak flow rate (Qmax) at 3- and 12 months, IPSS at 2 weeks, and quality of life and BPHII at 12 months. The primary safety endpoint was to demonstrate an observed rate of less than or equal to 10% postoperative urinary catheterization for more than seven days. After the three-month endpoint, all participants were unblinded to treatment; 53 of 66 participants in the sham treatment group elected to undergo the PUL procedure. Follow-up outcomes for those individuals were not reported in this study. At 12 months, 123 participants were included in the analysis: one participant dropped out, two were excluded due to significant protocol deviations, five participants elected to undergo PUL revision because of insufficient response, two participants elected prostate resection, and seven participants were removed due to BPH medication use. The primary study endpoint was met, as the mean PUL and sham AUASI was reduced by 11.1 (± 7.67) and 5.9 (± 7.66), respectively (p=0.003). PUL participants experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively (p <0.001). Peak urinary flow rate (Qmax improvement) increased 4.4 milliliters per second at three months and was sustained at 4.0 milliliters per second at 12 months (p <0.001). There was no statistical difference between groups in IIEF. Two serious adverse events were determined as related to the procedure (clot retention coincident with reinitiating warfarin therapy and removal of a bladder stone at 12 months). Less serious adverse events, including postoperative dysuria, hematuria, pain/discomfort and urgency were typically mild to moderate and resolved within two weeks. Limitations of this study include the lack of blinding and absence of a comparator treatment group beyond the primary study endpoint follow-up visit. The rate of blinding for participants was reported at 57% at the three month follow-up. Of the 140 participants in the treatment arm, 20% (17 participants) were excluded in the final analysis (unblinded phase) at 12 months.

Additional case series have evaluated data obtained from the two-year nonrandomized trial (Chin, 2012) and the L.I.F.T. trial (Roehrborn, 2013) for treatment of LUTS secondary to BPH. These retrospective reviews evaluate preservation of sexual function (McVary, 2014; Woo, 2012) and the surgical technique (McNicholas, 2013) involved with minimally invasive PUL. The studies corroborate the prior published results; however, larger prospective randomized studies with comparator treatment groups and long-term follow-up are needed to confirm the durability of the clinical benefits of PUL over standard surgical procedures for the treatment of LUTS secondary to BPH. 

Temporary Prostatic Stents

The use of temporary prostatic stents has been proposed as treatment of urinary obstruction due to BPH, following surgical treatment of BPH or prostate cancer, or following radiation therapy. Intraprostatic stenting has been investigated as a short-term treatment option permitting voluntary urination as an alternative to an indwelling bladder catheter with an external collection system. A temporary prostatic stent, The Spanner™ (SRS Medical, North Billerica, MA), received premarket approval (PMA) from the FDA based on a multicenter, prospective, randomized clinical trial designed to evaluate the safety and effectiveness of The Spanner to manage LUTS and bladder emptying following 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 benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization."

In The Spanner clinical investigation (Dineen, 2008; Shore, 2007), a total of 186 male subjects, 45 years of age and older, were randomized into two groups at a visit 3 to10 days following TUMT for BPH, indwelling bladder catheter removal, and demonstration of a successful voiding trial (defined as a post-void residual [PVR] less than 250 milliliters with mean voided volume of at least 100 milliliters). A total of 100 subjects who received The Spanner and 86 subjects in the control group were studied for changes in IPSS, PVR, and adverse events. Both groups were evaluated at one-, two-, and four week intervals during The Spanner indwelling period and at one- and four weeks after The Spanner removal. Beginning with preoperative IPSS scores of approximately 22 points, The Spanner group score decreased by 7.28 points compared to 4.42 points in the control group, a difference of 2.86 points (p=0.019). However, although evaluation at the one week interval revealed a significant difference of three points between the groups (p=0.047), at two weeks and at subsequent visits, this was no longer the case (p=0.084 at two weeks). Mean PVR was significantly less in The Spanner group compared to controls up to four weeks following randomization, with the mean decrease from pre-insertion baseline being 6.5 mls in The Spanner group versus a 28.5 ml increase in the control group. However, after four weeks there was no significant difference in PVR between the groups.

The FDA summary reported the majority of adverse events, greater than 75% for both groups, occurred during weeks one to four following insertion. Adverse events also occurred following removal of the device and included bleeding/hematuria, urinary frequency/retention/urgency, perineal pain, and symptomatic urinary tract infection. There were 385 adverse events reported by 99 subjects in The Spanner group and 273 adverse events reported by the 80 control group subjects. Of the urological adverse events requiring treatment, bacturemia occurred in 16.0% of The Spanner group compared to 10.5% in the control group. Micturition-burning was noted in 9.0% and 5.8%; perineal pain in 5.0% and 2.3%, respectively. However, the overall incidence of perineal pain was 26% in The Spanner group compared to 12.8% in the control group. Urinary retention (undefined) occurred in 10% and 15.1%, respectively. In The Spanner group, two of these occurred after removal of the temporary stent and 3% were associated with migration. The study results are limited in demonstrating meaningful improvement in clinical outcomes in the group that received the temporary prostatic stent compared to the subjects studied who had a successful voiding trial after BPH surgery. The clinical significance of decreased IPSS scores at one week only with a difference of three points at that visit is questionable as is the difference in PVR noted up to four weeks, in the absence of increased urinary tract infections or other PVR-related adverse effects in the control group compared to The Spanner group. On the other hand, perineal pain was noted to occur more frequently in The Spanner treated group.

Grimsley and colleagues (2007) retrospectively reviewed a series of 43 consecutive individuals who were treated with The Spanner for bladder-outlet obstruction because they were unfit for surgery (for example, comorbidity, usually pulmonary, cardiac, or both). Six (14%) of the individuals were receiving concomitant treatment for prostate cancer. It was reported that more than half of the individuals (63%) had unsatisfactory outcomes; the remaining 37% were considered to have had satisfactory outcomes with a stent in-situ after a mean of five changes or stent-free after a successful voiding trial. The authors suggest that, in this population, a temporary stent might be reasonably used only as a trial for placement of a permanent stent if voiding is unsuccessful. Additional study is needed to establish if use of The Spanner stent results in clinically significant improvement in health outcomes.

In summary, larger randomized controlled trials comparing minimally invasive treatments, including PAE, PUL, and temporary prostatic stents, are needed to determine their long-term efficacy compared to standard treatments for BPH.

Other Treatments for BPH

The AUA's updated Guideline on the Management of Benign Prostatic Hyperplasia (BPH) excludes a number of procedures from consideration in their treatment outcome analysis as there is insufficient and inadequate evidence available to make a recommendation for these procedures as a treatment alternative for an individual with moderate to severe symptoms of BPH. The level of evidence regarding the safety and utility of endoscopic balloon dilation, cryosurgical ablation, HIFU ablation, and the placement of stents, including a lack of treatment outcome analysis for temporary prostatic stents, is insufficient to draw any conclusions. Further studies are needed before determining the role of these treatments in the routine management of men with BPH (AUA, 2010).

Endoscopic balloon dilation for treatment of BPH involves the insertion of a balloon catheter tip through the urethra into the prostatic channel where it is inflated to stretch the urethra narrowed by the prostate. Based on the research, endoscopic balloon dilation has been inadequately studied with limited controlled trials, few long-term studies, and "a fallout in enthusiasm" for this treatment (Lukkarinen, 1999). The 4th International Consultation on BPH has rated balloon dilation as an unacceptable treatment option since 1995 (Denis, 1998).

HIFU ablation is a minimally invasive procedure using a transrectal ultrasound probe to image the prostate and deliver timed bursts of heat to create coagulation necrosis in a targeted area without harming adjacent healthy tissue (Leslie, 2006). Schatzl and colleagues (2000) compared the efficacy of TURP to four less invasive treatment options including HIFU in a small clinical trial. Randomization was attempted but could not be carried out because participant characteristics such as prostate size, prostatic calcifications and middle lobes limited the types of individuals who could receive the different treatments. The individuals who received HIFU tended to have smaller prostates and less severe symptoms than those who received TURP. A second study reported by Madersbacher and colleagues (2000) attempted to determine the long-term outcome after HIFU therapy for individuals with LUTS due to BPH. The data collected between June 1992 and March 1995 indicated that HIFU therapy for BPH, at least in its present form, did not "stand the test of time," as 43.8% of individuals had to undergo TURP within four years after initial therapy. Additional long-term studies are warranted to reliably assess the role of HIFU as an established alternative to standard treatments for BPH.

Surgical and Minimally Invasive Treatments for Genitourinary Conditions Other Than BPH

The efficacy of surgical and minimally invasive procedures including CLAP, holmium laser procedures, ILCP, PVP, RFNA/TUNA, TULIP, TUMT, VLAP, and WIT has not been established as treatment for prostatic or other genitourinary conditions other than BPH. The AUA's Guideline for the Management of Clinically Localized Prostate Cancer (AUA, 2010), the National Cancer Institute's Prostate Cancer Treatment (PDQ®) (NCI, 2013), and the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines inOncology-Prostate Cancer (V1.2014) (NCCN, 2013) do not address these procedures as a treatment option for prostate carcinoma and related conditions. The level of evidence supporting the use of the technologies mentioned 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.

Background/Overview

Description of Condition

BPH is a disorder caused by the overgrowth of the prostate gland, which then interferes with the function of the bladder and urethra. BPH is sometimes referred to as benign prostatic hypertrophy. This condition usually results in the increased frequency of urination, frequent nighttime urination (nocturia), urinary hesitancy and urgency, and weak urinary stream. These symptoms 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% to 50% of men ages 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

Treatment alternatives for individuals with moderate to severe symptoms of BPH may include watchful waiting, medical therapies, complementary and alternative medicines (CAM), minimally invasive therapies, and surgical therapies (AUA, 2010). 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. 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.

Other transurethral surgical and minimally invasive treatments for BPH are designed as an alternative to long-term medical therapy with the potential benefits of shorter hospital length of stay and decreased recovery time when compared to TURP. These surgical approaches include laser-based procedures, TUIP, TUVP, and minimally invasive procedures including TUMT, TUNA, and WIT. In these procedures, prostate tissue is removed through a heating method that destroys the desired amount of tissue that is 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.

Definitions

Ablation: To surgically remove or excise a body part.

Benign prostate hyperplasia (BPH): A condition that causes an increase in the size of the prostate gland in men, commonly causing difficulty in urination; also referred to as benign prostatic hypertrophy.

Contact laser ablation of the prostate (CLAP): A procedure where the tip of an Nd:YAG laser is placed in direct contact with prostate tissue, vaporizing it.

Cryosurgical: A treatment performed with an instrument that freezes and destroys abnormal tissue.

High-intensity focused ultrasound (HIFU) ablation of the prostate: A procedure that uses timed bursts of ultrasound to create coagulation necrosis in a targeted area of the prostate.

Holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP): Procedures that use a holmium laser fiber and specially adapted resectoscope to either ablate (HoLAP), enucleate (HoLEP), or resect (HoLRP) prostate tissue.

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

Hypertrophy: Enlargement or overgrowth of an organ or tissue due to an increase in size of its cells, rather than the number.

International Prostate Symptom Score (IPSS): An eight question, self-administered tool (seven symptom questions plus one quality of life question) used to screen for BPH-related symptoms.

Laser prostatectomy: A procedure that uses laser-generated heat to remove prostate tissue obstructing the urethra.

Lower urinary tract symptoms (LUTS): The chief complaint associated with BPH, typified by urinary frequency, urgency, nocturia, decreased and intermittent force of stream and the sensation of incomplete bladder emptying.

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: A surgical approach to prostate surgery that involves the insertion of surgical tools through the urethra instead of through an incision in the skin.

Transuretheral incision of the prostate (TUIP): A surgical procedure involving one or more lengthwise incisions in the prostate near the bladder, which opens the bladder neck and prostate to reduce pressure on the urethra; usually limited to treating smaller prostate glands (equal to or less than 30 grams).

Transurethral microwave thermotherapy (TUMT): A minimally invasive treatment that uses microwave energy to heat and shrink the prostate to provide relief of urinary obstruction due to BPH.

Transurethral radiofrequency needle ablation (TUNA, 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.

Transurethral vaporization of the prostate (TUVP): A surgical procedure where prostate tissue is vaporized using a grooved or spiked rollerball or thicker band-loop electrode, considered a modification of a transurethral resection of the prostate (TURP); also referred to as transurethral electrovaporization of the prostate (TUEVP, TUVAP, TUEVAP), transurethral evaporation (TUEP), or transurethral vapor resection of the prostate (TUVRP).

Vaporization procedures of the prostate: Procedures that use electrical energy to vaporize prostate tissues, differing from TURP and each other according to the type of electrode used and the magnitude of electrical energy applied. Prostate tissue is vaporized, resected into pieces or "chips," or coagulated. 

Visually guided laser ablation of the prostate (VLAP): A non-contact laser ablation procedure where a Nd:YAG laser is held a short distance (two millimeters) from the prostate tissue, destroying it by coagulation and allowing it to slough away over several weeks; reserved for treating small or moderately small prostates (less than 80 grams).

Water-induced thermotherapy (WIT): A minimally invasive approach to the treatment of BPH involving the use of very hot water to shrink prostate tissue; also referred to as thermourethral hot water therapy.

Coding

The following codes for treatments and procedures applicable to this document 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 
52450Transurethral incision of prostate [TUIP]
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
 All diagnoses

When services are also Medically Necessary:

CPT 
52647Laser coagulation of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included if performed)
52648Laser 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)
52649Laser enucleation of the prostate with morcellation, 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) [HoLRP]
53850Transurethral destruction of prostate tissue; by microwave thermotherapy [TUMT]
53852Transurethral destruction of prostate tissue; by radiofrequency thermotherapy [needle ablation, TUNA, RFNA]
53899Unlisted procedure, urinary system [when specified as transurethral destruction of prostate tissue: by water-induced thermotherapy (WIT)]
  
ICD-9 Procedure[For dates of service prior to 10/01/2014]
60.21Transurethral (ultrasound) guided laser induced prostatectomy (TULIP)
60.96Transurethral destruction of prostate tissue by microwave thermotherapy
60.97Other transurethral destruction of prostate tissue by other thermotherapy
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
596.0Bladder neck obstruction
600.00-600.91Hyperplasia of prostate
788.20-788.29Retention of urine
  
ICD-10 Procedure[For dates of service on or after 10/01/2014]
0V507ZZDestruction of prostate, via natural or artificial opening
0V508ZZDestruction of prostate, via natural or artificial opening endoscopic
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
N13.8Other obstructive and reflux uropathy
N32.0Bladder neck obstruction
N40.0-N40.3Enlarged prostate
R33.8Other retention of urine
R33.9Retention of urine, unspecified
R39.11-R39.19Other difficulties with micturition

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary. 

When services are Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as not medically necessary.

CPT 
53899Unlisted procedure, urinary system [when specified as transurethral balloon dilation of the prostatic urethra]
  
ICD-9 Procedure[For dates of service prior to 10/01/2014]
60.95Transurethral balloon dilation of the prostatic urethra
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
 All diagnoses

 When services are Investigational and Not Medically Necessary:

CPT 
53855Insertion of a temporary prostatic urethral stent, including urethral measurement
  
HCPCS 
C9739Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants
C9740Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
 All diagnoses

When Services are also Investigational and Not Medically Necessary:

CPT 
37243Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction [when specified as prostatic arterial embolization]
53899Unlisted procedure, urinary system [when specified as prostatic urethral lift procedure]
55873Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)
55899Unlisted procedure, male genital system [when specified as destruction of prostate tissue by high intensity focused ultrasound]
  
HCPCS 
C9734Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with magnetic resonance (MR) guidance
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
596.0Bladder neck obstruction
600.00-600.91Hyperplasia of prostate
788.20-788.29Retention of urine
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
N13.8Other obstructive and reflux uropathy
N32.0Bladder neck obstruction
N40.0-N40.3Enlarged prostate
R33.8Other retention of urine
R33.9Retention of urine, unspecified
R39.11-R39.19Other difficulties with micturition
  
References

Peer Reviewed Publications:

  1. Ahyai SA, Lehrich K, Kuntz RM. Holmium laser enucleation versus transurethral resection of the prostate: 3-year follow-up results of a randomized clinical trial. Eur Urol. 2007; 52(5):1456-1463.
  2. Al-Ansari A, Younes N, Sampige VP, et al. GreenLight HPS 120-W laser vaporization versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia: a randomized clinical trial with midterm follow-up. Eur Urol. 2010; 58(3):349-355.
  3. Albala DM, Fulmer BR, Turk TM, et al. Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000. J Endourol. 2002; 16(1):57-61.
  4. Antunes AA, Carnevale FC, da Motta Leal Filho JM, et al. Clinical, laboratorial, and urodynamic findings of prostatic artery embolization for the treatment of urinary retention related to benign prostatic hyperplasia. A prospective single-center pilot study. Cardiovasc Intervent Radiol. 2013; 36(4):978-986.
  5. Araki M, Lam PN, Wong C. High-power potassium-titanyl-phosphate laser photoselective vaporization prostatectomy for symptomatic benign prostatic hyperplasia. J Endourol. 2008; 22(6):1311-1314.
  6. Bagla S, Martin CP, van Breda A, et al. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014; 25(1):47-52.
  7. Bilhim T, Pisco J, Campos Pinheiro L, et al. Does polyvinyl alcohol particle size change the outcome of prostatic arterial embolization for benign prostatic hyperplasia? Results from a single-center randomized prospective study. J Vasc Interv Radiol. 2013a; 24(11):1595-1602.
  8. Bilhim T, Pisco J, Rio Tinto H, et al. Unilateral versus bilateral prostatic arterial embolization for lower urinary tract symptoms in patients with prostate enlargement. Cardiovasc Intervent Radiol. 2013b; 36(2):403-411.
  9. Bouza C, Lopez T, Magro A, et al. Systematic review and meta-analysis of transurethral needle ablation in symptomatic benign prostatic hyperplasia. BMC Urol. 2006; 6:14.
  10. Boyle P, Robertson C, Vaughan ED, et al. A meta-analysis of trials of transuretheral needle ablation for treating symptomatic benign prostatic hyperplasia. BJU Int. 2004; 94(1):83-88.
  11. Breda G, Isgro A. Treatment of benign prostatic hyperplasia with water-induced thermotherapy: experience of a single institution. J Endourol. 2002; 16(2):123-126.
  12. Carnevale FC, da Motta-Leal-Filho JM, Antunes AA, et al. Quality of life and clinical symptom improvement support prostatic artery embolization for patients with acute urinary retention caused by benign prostatic hyperplasia. J Vasc Interv Radiol. 2013; 24(4):535-542.
  13. 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. 2012; 79(1):5-11.
  14. Dahlstrand C, Waldén M, Geirsson G, Pettersson S. Transurethral microwave thermotherapy versus transurethral resection for symptomatic benign prostatic obstruction: a prospective randomized study with a 2-year follow-up. Br J Urol. 1995; 76(5):614-618.
  15. 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; 71(5):873-877.
  16. Ekengren J, Haendler, Hahn RG. Clinical outcome 1 year after transurethral vaporization and resection of the prostate. Urology. 2000; 55(2):231-235.
  17. Elmansy HM, Elzayat E, Elhilali MM. Holmium laser ablation versus photoselective vaporization of prostate less than 60 cc: long-term results of a randomized trial. J Urol. 2010; 184(5):2023-2028.
  18. Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): long-term results, reoperation rate, and possible impact of the learning curve. Eur Urol. 2007; 52(5):1465-1471.
  19. Floratos DL, Kiemeney LA, Rossi C, et al. Long-term followup of randomized transurethral microwave thermotherapy versus transurethral prostatic resection study. J Urol. 2001; 165(5):1533-1538.
  20. Grimsley SJ, Khan MH, Lennox E, Paterson PH. Experience with the spanner prostatic stent in patients unfit for surgery: an observational study. J Endourol. 2007; 21(9):1093-1096.
  21. Hill B, Belville W, Bruskewitz R, et al. Transurethral needle ablation versus transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia: 5-year results of a prospective, randomized, multicenter clinical trial. J Urol. 2004; 171(6 Pt 1):2336-2340.
  22. Hindley R, Mostafid A, Brierly R et al. The 2-year symptomatic and urodynamic results of a prospective randomized trial of interstitial radiofrequency therapy vs transurethral resection of the prostate. BJU Int. 2001; 88(3): 217-220.
  23. Kaye JD, Smith AD, Badlani GH, et al. High-energy transurethral thermotherapy with CoreTherm approaches transurethral prostate resection in outcome efficacy: a meta-analysis. J Endourol. 2008; 22(4):713-718.
  24. Kuntz RM, Lehrich K, Ahyai SA. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomized clinical trial. Eur Urol. 2008; 53(1):160-166.
  25. Leslie TA, Kennedy JE. High-intensity focused ultrasound principles, current uses, and potential for the future. Ultrasound Q. 2006; 22(4):263-272.
  26. Lukkarinen O, Lehtonen T, Talja M, et al. Finastreride following balloon dilatation of the prostate. A double-blind, placebo-controlled multicenter study. Ann Chir Gynaecol. 1999; 88(4):299-303.
  27. Madersbacher S, Schatzl G, Djavan B, et al. Long-term outcome of transrectal high-intensity focused ultrasound therapy for benign prostatic hyperplasia. Eur Urol. 2000; 37(6):687-694.
  28. McNicholas TA, Woo HH, Chin PT, et al. Minimally invasive prostatic urethral lift: surgical technique and multinational experience. Eur Urol. 2013; 64(2):292-299.
  29. McVary KT, Gange SN, Shore ND, et al. L.I.F.T. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. 2014; 11(1):279-287.
  30. Miller PD, Kastner C, Ramsey EW, Parsons K. Cooled thermotherapy for the treatment of benign prostatic hyperplasia: durability of results obtained with the Targis System. Urology. 2003; 61(6):1160-1164.
  31. 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(5):1565-1569.
  32. Mynderse LA, Roehrborn CG, Partin AW, et al. Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for benign prostatic hyperplasia. J Urol. 2011; 185(5):1804-1810. Erratum in: J Urol. 2011; 186(1):355.
  33. 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(9):853-862.
  34. Ohigashi T, Nakamura K, Nakashima J, et al. Long-term results of three different minimally invasive therapies for lower urinary tract symptoms due to benign prostatic hyperplasia: comparison at a single institute. Int J Urol. 2007; 14(4):326-330.
  35. Pisco JM, Rio Tinto H, Campos Pinheiro L, et al. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up. Eur Radiol. 2013; 23(9):2561-2572.
  36. Poulakis V, Dahm P, Witzsch U, et al. Transurethral electrovaporization vs transurethral resection for symptomatic prostatic obstruction: a meta-analysis. BJU Int. 2004; 94(1):89-95.
  37. Riehmann M, Knes JM, Heisey D, et al. Transurethral resection versus incision of the prostate: a randomized, prospective study. Urology. 1995; 45(5):768-775.
  38. Rio Tinto H, Martins Pisco J, Bilhim T, et al. Prostatic artery embolization in the treatment of benign prostatic hyperplasia: short and medium follow-up. Tech Vasc Interv Radiol. 2012; 15(4):290-293.
  39. Roehrborn CG, Burkhard F, Bruskewitz R, et al. The effects of transurethral needle ablation and resection of the prostate on pressure flow urodynamic parameters: analysis of the United States randomized study. J Urol. 1999; 162(1):92-97.
  40. 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. 2013; 190(6):2161-2167.
  41. Ruszat R, Wyler SF, Seitz M, et al. Comparison of potassium-titanyl-phosphate laser vaporization of the prostate and transurethral resection of the prostate: update of a prospective non-randomized two-centre study. BJU Int. 2008; 102(10):1432-1438. 
  42. Schatzl G, Madersbacher S, Djavan B, et al. Two-year results of transurethral resection of the prostate versus four 'less invasive' treatment options. Eur Urol. 2000; 37(6):695-701.
  43. Shah HN, Mahajan AP, Hegde SS, Bansal MB. Peri-operative complications of holmium laser enucleation of the prostate: experience in the first 280 patients, and a review of literature. BJU Int. 2007; 100(1):94-101.
  44. Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007; 177(3):1040-1046.
  45. Stafinski T, Menon D, Harris K, et al. Photoselective vaporization of the prostate for the treatment of benign prostatic hyperplasia. Can Urol Assoc J. 2008; 2(2):124-134.
  46. Tan A, Liao C, Mo Z, Cao Y. Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. Br J Surg. 2007; 94(10):1201-1208.
  47. Tkocz M, Prajsner A. Comparison of long-term results of transurethral incision of the prostate with transurethral resection of the prostate, in patients with benign prostatic hypertrophy. Neurourol Urodyn. 2002; 21(2):112-116.
  48. Tugcu V, Tasci AI, Sahin S, Zorluoglu F. Comparison of photoselective vaporization of the prostate and transurethral resection of the prostate: a prospective nonrandomized bicenter trial with 2-year follow-up. J Endourol. 2008; 22(7):1519-1525.
  49. 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):1411-1416.
  50. 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):1058-1062.
  51. Vesely S, Knutson T, Dicuio M, et al. Transurethral microwave thermotherapy: clinical results after 11 years of use. J Endourol. 2005; 19(6):730-733.
  52. Wagrell L, Schelin S, Nordling J, et al. Three-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study. Urology. 2004; 64(4):698-702.
  53. Westenberg A, Gilling P, Kennet K, et al. Holmium laser resection of the prostate versus transurethral resection of the prostate: results of a randomized trial with 4-year minimum long-term follow-up. J Urol. 2004; 172(2):616-619.
  54. Wilson LC, Gilling PJ, Williams A, et al. A randomized trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years. Eur Urol. 2006; 50(3):569-573.
  55. 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. 2012; 9(2):568-575.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Urological Association (AUA). Clinical guidelines. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm. Accessed on December 19, 2013.
    • Guideline for the Management of Clinically Localized Prostate Cancer. 2007. Reviewed and validity confirmed 2011.
    • Guideline on the Management of Benign Prostatic Hyperplasia (BPH). Revised 2010.
  2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination for Laser Procedures. NCD #140.5. Effective May 1, 1997. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=140.5&ncd_version=1&basket=ncd%3A140%2E5%3A1%3ALaser+Procedures. Accessed on December 19, 2013. 
  3. Denis L, McConnell J, Khoury S, et al. Recommendations of the International Scientific Committee: the evaluation and treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction. Proceedings of the Fourth International Consultation on Benign Prostatic Hyperplasia. United Kingdom: Health Publications, Ltd. 1998; 669-684.
  4. Hoffman RM, MacDonald R, Wilt T. Laser prostatectomy for benign prostatic obstruction. Cochrane Database Syst Rev. 2004; (1):CD001987.
  5. Hoffman RM, Monga M, Elliot SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2012; (9):CD004135.
  6. National Institute for Health and Clinical Excellence (NICE). Interventional procedure guidance 453. Prostate artery embolization for benign prostate hyperplasia. April 2013. Available at: http://guidance.nice.org.uk/IPG453/Guidance/pdf/English. Accessed on December 24, 2013.
  7. NCCN Clinical Practice Guidelines in Oncology™. © 2013 National Comprehensive Cancer Network, Inc. Prostate cancer. V1.2014. November 27, 2013. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on December 24, 2013.
  8. Society of Interventional Radiology (SIR). 2013 Research Consensus Panel. Prostatic artery embolization for treatment of benign prostatic hyperplasia (BPH). Available at: http://www.sirfoundation.org/consensus-panels/. Accessed on January 6, 2014.
Websites for Additional Information
  1. National Cancer Institute (NCI). Prostate cancer treatment (PDQ®). December 12, 2013. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient. Accessed on December 24, 2013.
  2. National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC, NIH). Prostate enlargement: benign prostatic hyperplasia. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/prostateenlargement/. Accessed on December 24, 2013.
Index

GreenLight HPS® Laser System 
GreenLight XPS™ Laser System
Holmium Laser (Ho:YAG)
Indigo LaserOptic Treatment® System
Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) Laser
Proleive Thermodilatation System
ProstaLund CoreTherm System
Prostatron System
Prostiva RF Therapy
Targis System
The Spanner Temporary Prostatic Stent
TherMatrx Office Thermo Therapy
UroLift System

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.

Document History
StatusDateAction
Revised02/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Combined existing investigational and not medically necessary statements for cryosurgical ablation and HIFU, adding new criteria for prostatic artery embolization (PAE) and prostatic urethral lift (PUL) for the treatment of symptomatic BPH. Updated and reordered Rationale section. Updated Background, Definitions, References, Websites for Additional Information, and Index sections..  Updated Coding section to include 04/01/2014 HCPCS changes.
Reviewed02/14/2013MPTAC review. Updated Rationale, Coding, References, Websites for Additional Information, and Index.
Reviewed02/16/2012MPTAC review. Updated Rationale, Discussion, Coding, References, Websites for Additional Information, and Index.
Reviewed05/19/2011MPTAC review. Updated Rationale, Background, Definitions, References, and Index. Added section: Websites for Additional Information.
Reviewed05/13/2010MPTAC review. Updated Rationale, Coding, and References.
 01/01/2010Updated Coding section with 01/01/2010 CPT changes; removed CPT 0084T deleted 12/31/2009.
Reviewed05/21/2009MPTAC review. Clarified medically necessary Position Statement, adding HoLAP and HoLEP as Holmium laser procedures; clarified VLAP statement, adding non-contact laser ablation of the prostate; added transurethral to electrovaporization and (TURVP, TUVP, TVP) acronyms. Clarified investigational and not medically necessary statement, adding (HoLAP, HoLEP) as Holmium laser prodecures and non-contact laser ablation of the prostate to the VLAP statement. Updated Rationale, Discussion, Definitions, Index, and References.
 01/01/2009Updated Coding section with 01/01/2009 CPT changes; removed CPT 53853 deleted 12/31/2008.
Revised05/14/2008MPTAC review. Revised document title to address the surgical and minimally invasive treatments that are considered investigational and not medically necessary for all genitourinary conditions other than BPH. Updated Rationale and References.
Revised02/21/2008MPTAC review. Revised document title from Surgery for Benign Prostatic Hypertrophy (BPH) to Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH). Reformatted and separated Position Statements to identify surgical and minimally invasive procedures. Updated Rationale, Background, Definitions, and References.
 01/01/2008Updated Coding section with 01/01/2008 CPT changes; removed CPT 52510 deleted 12/31/2007.  The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."  This change was approved at the November 29, 2007 MPTAC meeting.
Revised03/08/2007MPTAC review. Position Statement change, medically necessary criteria revised. Rationale and References updated.
Reviewed03/23/2006MPTAC review. Updated References.
 01/01/2006Updated Coding section with 01/01/2006 CPT/HCPCS changes
 11/18/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised04/28/2005MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review DateDocument NumberTitle

Anthem, Inc.

 

01/13/2005SURG.00028Surgery for Benign Prostatic Hypertrophy (BPH)
WellPoint Health Networks, Inc.12/02/20043.08.02Treatment of Benign Prostatic Hypertrophy
 12/02/20043.08.05Temporary Prostatic Stent