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Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia (BPH)
11.17.06q

Policy

MEDICALLY NECESSARY

SURGICAL AND MINIMALLY INVASIVE TREATMENT
The surgical and minimally invasive treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • One of the following surgical or minimally invasive treatments is utilized:
    • Transurethral resection of the prostate (TURP)
    • Holmium laser ablation of the prostate [HoLAP])
    • Holmium laser enucleation of the prostate [HoLEP]
    • Holmium laser resection of the prostate [(HoLRP]
    • Photoselective vaporization (PVP)
    • Transurethral electrovaporization of the prostate (TUVP)
    • Transurethral microwave thermotherapy (TUMT)
    • Transurethral incision of the prostate (TUIP)
    • Simple prostatectomy
  • The individual is 45 years or older with one of the following conditions attributed to BPH:
    • Mild to moderate lower urinary tract symptoms (LUTS) (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) refractory to medication or is unwilling to take daily medication.
    • Renal insufficiency
    • Refractory urinary retention
    • Recurrent urinary tract infections (UTIs)
    • Recurrent bladder stones or gross hematuria
  • The individual has a prostate-specific antigen (PSA) blood test that meets both of the following criteria:
    • Performed within 12 months of the procedure
    • Resulted in a value of 2.5 ng/mL or less for individuals who are up to and including 60 years of age and 4.0 ng/mL or less for individuals who are over 60 years of age
  • The individual has a peak urine flow rate (Qmax) less than or equal to 12cc/sec on a voided volume that is greater than 125 cc.
  • The individual has failed a trial of satisfactory voiding with medication (alpha blocker and/or alpha-reductase inhibitor) or intolerance to medication (alpha blocker and/or 5-alpha-reductase inhibitor).
PROSTATIC URETHRAL LIFT
Prostatic urethral lift (i.e., UroLift) for the treatment of urinary outlet obstruction due to BPH is considered medically necessary and, therefore covered when all of the following criteria are met:
  • The individual is age 45 years or older and has a diagnosis of LUTS secondary to BPH (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) that interfere with activities of daily living.
  • The individual has a peak urine flow rate (Qmax) less than or equal to 12 cc/sec on a voided volume that is greater than 125 cc.
  • The individual's symptoms are caused by enlargement of the lateral or median lobes of the prostate and a prostate volume that is less than or equal to 100cc.
  • The individual has normal renal function.
  • The individual has had an adequate trial of, but is refractory to or intolerant of, the usual prescribed BPH medication.
  • The individual is a poor candidate for other surgical interventions for BPH, or the individual opts to undergo a minimally invasive procedure.
  • The individual does not have a contact dermatitis nickel, titanium, or stainless steel allergy.
  • The individual has had appropriate testing to exclude diagnosis of prostate cancer.
WATER-JET HYDROSECTION (AQUABLATION)
Water-jet hydrosection (Aquablation) for the treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) is considered medically necessary and, therefore, covered once per lifetime when all of the following criteria are met:
  • The individual is age 80 years or younger with prostate volume of 30-150 cc by transrectal ultrasound (TRUS) and persistent moderate to severe symptoms despite maximal medical management including ALL of the following attributed to BPH:
    • The individual has an International Prostate Symptom Score (IPSS) of equal to or greater than 12. 
    • The individual has a peak urine flow rate (Qmax) less than or equal to 15mL/sec on a voided volume that is greater than 125 cc.
    • The individual has had a failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride). 
  • The individual has none of the following:
    • Severe obesity (BMI ≥ 42kg/m2)
    • Known or suspected prostate cancer or a prostate specific antigen (PSA) >10 ng/mL unless there has been a negative prostate biopsy within the last 6 months
    • Bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum
    • Damaged external urinary sphincter
    • Treatment for chronic prostatitis
    • Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture
    • Active urinary tract or systemic infection
    • Known allergy to device materials
    • Inability to safely stop anticoagulants or antiplatelet agents preoperatively
WATER VAPOR THERMOTHERAPY (REZŪM)
Transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy (Rezū​m) for the treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) in individuals 45 years or older is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • Prostate gland volume is less than or equal to 80 grams​.
  • The individual has an International Prostate Symptom Score (IPSS) of equal to or greater than 12. 
  • The individual has had appropriate testing to exclude diagnosis of prostate cancer.​
  • The individual has failed a trial of satisfactory voiding with medication (alpha blocker and/or alpha-reductase inhibitor) or intolerance to medication (alpha blocker and/or 5-alpha-reductase inhibitor).​
NOT MEDICALLY NECESSARY

The following obsolete medical services are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury:
  • Visual laser ablation of the prostate (VLAP)
  • Interstitial laser coagulation (ILC)
  • Transurethral ultrasound-guided laser-induced prostatectomy (TULIP)
  • Water-induced thermotherapy (WIT)
  • Transurethral needle ablation (TUNA)
EXPERIMENTAL/INVESTIGATIONAL

The following procedures are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness in the treatment of urinary outlet obstruction due to BPH has not been established by review of the available published peer-reviewed literature:
  • Balloon dilation of the prostate
  • Transurethral ethanol ablation of the prostate (TEAP)
  • High-intensity focused ultrasound (HIFU) of prostate
  • Prostate artery embolization (PAE)
REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Serum prostate-specific antigen (PSA) level and prostate size should not be used as the sole basis of treatment recommendations.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, surgical and minimally invasive treatments for urinary outlet obstruction due to BPH are covered under the medical benefits of the Company’s products when medical necessity criteria listed in the medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The use of devices in the minimally invasive treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) should be in accordance with all of the FDA-approved labeling requirements and/or criteria.

Description

Urinary outlet obstruction is difficulty in the passage of urine from the bladder to the urethra caused by compression or resistance on the bladder outflow channel at any location from the bladder neck to the urethral meatus. In males, this can be caused by benign prostatic hyperplasia (BPH). BPH is a common age-related, noncancerous condition in men that is characterized by an increase of epithelial and stromal cells in the periurethral area of the prostate. This increase in cells causes an enlargement of the prostate gland. This pathologic change is important because of the proximal anatomical relationship between the prostate and the bladder neck. The condition generally involves lower urinary tract symptoms (LUTS), which may include increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying. Given the substantive symptomatic impact of urinary outlet obstruction, symptomatic appraisal of interference with activities of daily living is a crucial aspect of evaluation. In an effort to quantify the severity of symptomatic BPH, a urodynamic investigation (e.g., urine flow rate assessment) may be performed.

Treatment for BPH includes watchful waiting (e.g., active surveillance), medical management with pharmacotherapy (e.g., alpha-blockers, 5-alpha-reductase inhibitors), minimally invasive treatments (e.g., transurethral microwave thermotherapy [TUMT]), and surgery (e.g., TURP, laser treatments). If there is minimal interference with activities of daily living and no evidence of prostate enlargement, watchful waiting may be utilized. Medical management may be indicated for individuals with uncomplicated BPH or moderate to severe symptoms, and individuals who are waiting for surgery, unwilling to undergo surgery, or are poor surgical candidates. Individuals with BPH who have complications such as acute urinary retention, recurrent urinary tract infections, hematuria, bladder stones, or renal insufficiency/failure due to BPH may be treated surgically. Untreated BPH may worsen over time and increase the risk of stones, infection, or kidney failure. The choice of treatment for urinary outlet obstruction due to BPH should be based on the individual's presentation and anatomy, the surgeon's level of training and experience, and a discussion of the potential benefits and risks for complications.

The primary goal of treatment is to alleviate bothersome symptoms (i.e., symptoms that interfere with activities of daily living) that result from prostatic enlargement. More recently, treatment has been focused on altering disease progression and preventing complications associated with BPH. Standard surgical treatments such as transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP) (in which an incision is made where the prostate meets the bladder), and open prostatectomy may be accompanied by undesirable complications such as blood loss, need for transfusion, salt imbalances from fluid absorption, and side effects such as incontinence and retrograde ejaculation. Newer surgical techniques that use lasers, as well as minimally invasive techniques that use various sources of energy such as heat, microwaves, radiofrequency, and ultrasound, have been developed.

STANDARD TREATMENTS

SURGICAL TREATMENTS
Transurethral Resection of the Prostate (TURP)

Transurethral resection of the prostate (TURP) is the standard treatment for BPH against which all treatments are measured. TURP involves removing the core of the prostate through the urethra using instruments and electrodissection. An electrified wire loop removes pieces of prostatic tissue and coagulated blood. TURP is performed under general or spinal anesthesia and requires a hospital stay.

Simple Prostatectomy

Simple prostatectomy is a standard surgical procedure that can be performed open or robotically in which the obstructing prostate tissue is removed through a lower abdominal incision using a suprapubic (through the bladder) or retropubic (through the prostate capsule) approach. The obstructing tissue that is blocking the flow of urine is excised in one piece and the prostate capsule is removed. Simple prostatectomy is a treatment option for relieving bladder outlet obstruction for individuals with prostate glands greater than 75 to 100 grams.

Transurethral Incision of the Prostate (TUIP)

Transurethral incision of the prostate (TUIP) is a surgery usually limited to small prostate glands of 30 grams or less, in which two lengthwise internal incisions in the prostate near the bladder are made, opening the bladder neck and prostate, reducing pressure on the urethra. TUIP can be performed as an outpatient under regional or general anesthesia.

THERMAL TREATMENT
Transurethral Electrovaporization of the Prostate (TUVP)

Transurethral electrovaporization of the prostate (TUVP), usually an outpatient procedure, vaporizes the enlarged prostate tissue, destroying it by coagulation and allowing it to slough away over several weeks. TUVP steams the tissue away using high heat, and dries out the tissue using lower heat. Advantages of TUVP have shown earlier post-treatment catheter removal and fewer bleeding-related complications when compared to TURP. Evidence in the available published peer-reviewed literature demonstrates the safety and effectiveness of TUVP for the treatment of BPH (Poulakis 2004).

LASER TREATMENTS

These procedures involve a laser fiber that is passed into the prostatic channel under telescopic guidance. The laser is then used, through vaporization or ablation techniques, to destroy the obstructing portions of the prostate with heat. With laser vaporization, high instantaneous heat is created to vaporize or steam away prostate tissue. Lower laser energy is applied with laser ablation, which heats the tissue enough to dry it out and allows it to shrink and slough away with time.

Visual Laser Ablation of the Prostate (VLAP)

VLAP delivers a laser energy that is focused, without direct contact with the prostate, on the enlarged prostatic tissue, and causes thermal injury or coagulation necrosis of the tissue. The primary mechanism of tissue destruction is coagulation rather than vaporization, and the coagulated tissue sloughs away over several weeks following VLAP. VLAP requires a post-treatment catheterization from several days to several weeks. Community practice suggests that VLAP is not commonly used for the treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH), as laser vaporization is now used.

Interstitial Laser Coagulation (ILC)

ILC utilizes a fiber-optic laser probe that is inserted through a cystoscope into the prostate at fixed points. Laser energy is applied to coagulate each area of obstructing prostate tissue, producing coagulation necrosis. In contrast to other laser procedures, where coagulation necrosis occurs at the urethral surface, in interstitial laser coagulation, delivery of laser energy directly into the tissues produces coagulation necrosis inside the enlarged prostatic tissue. The treated tissue is absorbed over a period of several weeks. Community practice suggests that ILC is no longer considered a standard or an option for the treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH).

Transurethral Ultrasound-Guided Laser-Induced Prostatectomy (TULIP)

TULIP was one of the first laser treatments used for BPH. A laser probe is housed between two ultrasound transducers that are used for real-time scanning to position the laser while it is being used. Coagulation necrosis of the prostate tissue produces shrinking over several weeks following TULIP. TULIP has been replaced by other laser techniques that have fewer side effects, shorter post-treatment catheterization times, and fewer urinary symptoms. TULIP is not mentioned in any of the evidence-based BPH guidelines. Because this treatment appears to be outdated, results of controlled trials are no longer considered. Community practice suggests that TULIP is no longer considered a standard or an option for the treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH).

Holmium laser

Holmium laser treatments of the prostate are treatments that use a holmium laser fiber and a specially adapted resectoscope to ablate, resect, or enucleate enlarged prostatic tissue. Relief of obstruction is immediate. Holmium lasers are among the most common laser technologies used to treat prostate disease. With the holmium laser, there is the ability to coagulate tissue simultaneously with tissue incision, ablation, resection, or enucleation. This reduces intraoperative blood loss as well as post-operative bleeding. The American Urological Association (AUA 2010) states that holmium laser treatments are appropriate and effective treatment alternatives to TURP and open prostatectomy in individuals with moderate to severe LUTS due to BPH, and/or who are significantly bothered by these symptoms (i.e., interfere with activities of daily living). Additionally, according to AUA, these treatments have been associated with shorter post-treatment catheterization time and shorter length of hospital stay.
  • Holmium laser ablation of the prostate (HoLAP)
    This technology delivers laser energy at a wavelength of infrared range which is primarily absorbed by water. HoLAP is intended to be comparable to TURP, in that the prostatic lobes may be vaporized down to a surgical capsule resulting in a TURP-like effect. HoLAP does not yield tissue for histologic analysis. A controlled trial reported that although HoLAP took longer to perform than TURP, LUTS due to BPH and physiological measures improved to a similar degree after HoLAP and TURP (Mottet 1999).
  • Holmium laser resection of the prostate (HoLRP)
    This technology utilizes a specially adapted resectoscope to resect prostate tissue into pieces small enough to be removed with bladder irrigation and grasping forceps or a modified resectoscope loop. Improvements in LUTS due to BPH obtained by using HoLRP are comparable to TURP (Gilling 1999, Ruzat 2008).
  • Holmium laser enucleation of the prostate (HoLEP)
    HoLEP is typically used for larger glands that previously would have been treated with an open prostatectomy. Here, an entire prostatic lobe can be separated from connective tissue and deposited in the bladder. The tissue is then extracted from the bladder. HoLEP has been evaluated in clinical trials and compared favorably with TURP in meta-analyses and system reviews (Kuntz 2002, Elzayat 2007, Naspro 2009, Burke 2010).
Photoselective Vaporization (PVP)

PVP uses a potasium-titanyl-phosphate (KTP) laser to vaporize prostate tissue. KTP laser wavelengths penetrate only 1 to 2 mm, and the vaporization process may help avoid the perioperative side effects such as tissue sloughing. Additional reported potential advantages of PVP include virtually bloodless tissue ablation, shorter length of hospital stay, and shorter post-treatment catheterization times. As compared with TURP, surgical treatment of high-risk populations such as individuals taking anticoagulants, may be possible with PVP (Burke 2010, Ruszat 2008). PVP is an appropriate and effective treatment alternative to TURP and open prostatectomy in men who have moderate to severe LUTS due to BPH and/or who are significantly bothered by the symptoms (i.e., interfere with activities of daily living).

MINIMALLY INVASIVE TREATMENTS
Although TURP is the most commonly used treatment option for BPH, minimally invasive treatments have been developed that utilize various sources of energy, such as heat, radiofrequency, ultrasound, and microwaves.

Water-Induced Thermotherapy (WIT)

During this minimally invasive treatment, heated water is circulated through a proprietary closed-loop catheter system to produce coagulative necrosis and secondary ablation of obstructing prostatic tissue. Thermal insulation of the catheter shaft along the penile, bulbous, and membranous urethra, as well as in the sphincter region, prevents unwanted incidental damage of tissue along the urinary tract. According to the Urologic Clinics of North America, along with a review of the available published peer-reviewed literature and clinical guidelines, there is insufficient evidence to support the use of WIT for the treatment of urinary outlet obstruction due to BPH.

Balloon Dilation of the Prostate

This minimally invasive treatment utilizes a flexible balloon catheter, which is placed in the urethra at the level of the prostate above the external sphincter. The balloon is then inflated for a short time to distend the prostatic urethra. Currently, the AUA does not recommend the use of balloon dilation of the prostate. Furthermore, the safety and/or efficacy of this service cannot be established by review of the available published peer-reviewed literature.

Transurethral Ethanol Ablation (Chemoablation) of the Prostate (TEAP)

This minimally invasive treatment involves injecting absolute ethanol transurethrally into the prostate tissue. The injected ethanol causes cells of the prostate to burst, killing the cells. The prostate shrinks as the necrosed cells are absorbed. Currently, the AUA does not recommend the use of transurethral ethanol ablation of the prostate. Furthermore, the safety and/or efficacy of this service cannot be established by review of the available published peer-reviewed literature.

High-Intensity Focused Ultrasound (HIFU)

This minimally invasive treatment uses targeted high-intensity ultrasound to create coagulation necrosis in the prostate tissue. In contrast to other treatments, the HIFU device is inserted rectally and does not contact the prostate or urethra. Post-treatment catheterization time ranges from a few days to over a week. The safety and/or efficacy of this service cannot be established by review of the available published peer-reviewed literature. Randomized controlled trials comparing HIFU to standard treatments for BPH have not been published. Furthermore, at this time, the AUA considers HIFU as investigational, with additional long-term studies being warranted.

Transurethral Needle Ablation (TUNA) of the Prostate (Also Called Transurethral Radiofrequency Needle Ablation [RFNA])

This minimally invasive treatment delivers selective thermal energy to the prostate using two 18-gauge needles at the end of a TUNA catheter. A lens inside the catheter is used to guide the placement of the catheter into the urethra, where the needles are advanced to cause heat-induced coagulation necrosis in the prostate parenchyma. The prostate shrinks as the necrosed cells are absorbed. AUA recommends the use of TUNA as an appropriate and effective treatment alternative for bothersome (i.e., interfere with activities of daily living), moderate, or severe LUTS due to BPH. TUNA has been compared favorably with TURP in clinical trials and meta-analysis (Bouza 2006, Boyle 2004, Hill 2004). Although the improvement of LUTS due to BPH does not reach the same level as TURP; fewer adverse events (e.g., incontinence, retrograde ejaculation) are demonstrated.

Transurethral Microwave Thermotherapy (TUMT)

This minimally invasive treatment begins by introducing a coolant into the urethra through a transurethral probe, which cools the urethra, followed by a microwave emission that heats and ultimately ablates prostatic tissue. AUA recommends the use of TUMT as an appropriate and effective treatment alternative for bothersome (i.e., interfere with activities of daily living), moderate, or severe LUTS due to BPH (Hoffman 2007).

Prostatic Urethral Lift (UroLift ®)

The UroLift ® system is a minimally invasive implant developed to treat LUTS related to urinary outflow obstruction secondary to BPH in men 50 years of age or older. In this procedure, permanent implants (made from common implantable materials: nitinol, stainless steel, and polyethylene terepthalate) are delivered trans-prostatically to retract the enlarged lateral lobes of the prostate. This procedure dilates the prostatic urethra in individuals leading to improvement in LUTS symptoms without the need for surgical resection or the application of thermal energy to the prostate. Current evidence for this intervention includes 1 randomized sham-controlled trial (n = 206) published by Roehrborn et al. (2013) which found that at 12-month follow-up, both objective and subjective outcomes were significantly improved in individuals undergoing the UroLift procedure with no adverse impact to sexual function reported among any of the participants. An RCT directly comparing UroLift to TURP was completed in January 2016 concluding individuals who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as treatment for BPH.

Water-Jet Hydrosection (Aquablation)

The aquablation system is a novel surgical treatment for BPH, developed by Procept BioRobotics, that delivers a high-velocity saline stream under precise electrochemical control and live ultrasound guidance to ablate prostatic glandular tissue. The surgeon-guided aqua-beam ablates the prostatic tissue accurately following a preprogrammed routine, and the ablated prostatic tissue is simultaneously collected for post-procedure analysis. 

A prospective, multi-center, randomized control trial (Gilling et al 2015) assessed outcomes for individuals with LUTS treated with aquablation to individuals utilizing TURP with a primary efficacy endpoint of the difference between groups in the change in IPSS at 6 month in a non-inf​eriority study design. In this pivotal study, the primary endpoints for safety and efficacy will be ​were assessed at 3 and 6 months, respectively, and participants were followed out to for 3 years to collect long-term clincal data. At 6 months, mean IPSS decreased from baseline by 16.9 points for aquablation and 15.1 points for TURP (mean difference 1.8 points; p <.0001 for noninferiority). Gilling et al (2019) published two-year outcomes from the original participants in the pivotal study, demonstrating that IPSS score improvement was sustained (14.7 in Aquablation and 14.9 in TURP [p=0.834, 95% CI for difference -2.1 to 2.6]), and Qmax improvement was large in either trial arm (11.2 and 8.6 cc/s for Aquablation and TURP, respectively [p = 0.1880, 95% CI for difference -1.3 to 6.4]). Two-year reduction in post-void residual (PVR) was 57 and 70 cc for Aquablation and TURP, respectively (p = 0.3894). Prostate-specific antigen (PSA) decreased significantly in both groups by 1 point (p < 0.01). Gilling et al (2020) reported trial results at 3 years, and observed improvements in symptoms and quality of life were maintained through 3 years in both treatment groups, and the rate of serious adverse events did not differ between groups any any time point. The 2021 AUA Guidelines provide a moderate recommendation for the use of Aquablation (Water Jet Hydrosection) to be offered to individuals with LUTS attributed to BPH, provided prostate volume is 30-80cc​​. ​
Transurethral Destruction of Prostate Tissue by Radiofrequency-Generated Water Vapor Thermotherapy (Rezūm System)

Radiofrequency generated water vapor thermotherapy is being evaluated as a treatment for LUT's due to BPH. The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men >50 years of age with a prostate volume >30 cm3 and <80 cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. Rezūm uses convective radiofrequency water vapor thermal technology to apply thermal energy to prostate tissue through transurethral needle ablation. The system includes a reusable generator and a disposable delivery device kit. The delivery device is similar in size and shape to a cystoscope and allows for direct visualization via a rigid cystoscope lens port, delivery of water vapor through a needle located at the tip, and saline irrigation to facilitate visualization and cool the urethra. The procedure can be performed in an office or outpatient setting. FDA granted 510(k) marketing clearance for the Rezūm System (K180237) in February 2018.

The seminal publication (McVay et al, 2016) for transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy (Rezūm​) was an open-label, sham-controlled study on 197 individuals comparing the difference in the change from baseline between the treatment and control arms at 3 months post-treatment. Secondary outcome was the percentage of responders at 3 months. Response was defined as a 30% or greater reduction in the IPSS at 3 months compared to baseline. The Rezum group demonstrated a decrease in IPSS ​of 11.2 point compared to a 4.3-point decrease in the sham group (p<0.001). Subsequently, McVay et al have published uncontrolled, open-label crossover data at various intervals: three year (2018), four year (2019) and five year (2020), which reported on longer-term outcomes of the original study. Urinary symptoms and quality of life remained significantly improved from baseline out up to 5 years. Although, the longer-term studies observed a high loss of follow-up, over 5 years, the surgical retreatment rate was 4.4% and the medication retreatment rate was 11.1%.   The American Urological Association (AUA) considers Rezūm as a treatment modality for individuals with LUTS/BPH provided prostate volume 30-80cc as a moderate recommendation. ​

Prostate Artery Embolization (PAE)

Prostate artery embolization (PAE) is proposed as a minimally invasive procedure as an alternative to transurethral resection of the prostate (TURP) or open prostatectomy for treatment of BPH. PAE for BPH is intended to reduce the blood supply of the prostate gland, causing some of it to undergo necrosis with subsequent shrinkage. The procedure is performed under local anesthesia and sedation using a percutaneous transfemoral approach.

In 2016, Wang et al. in a systematic review and meta-analysis, evaluated the efficacy and safety of prostatic arterial embolization (PAE) on lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH). The authors concluded data in the studies were insufficient to determine whether or not PAE is as good as a TURP. Similar conclusions were reported in a systematic review and meta-analysis in 2017 by Pyo et al. and Kuang et al.

References

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Elzayat EA, Elhilali MN. 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.

Fitzpatrick JM, et al. Minimally invasive and endoscopic management of benign prostatic hyperplasia. In: Wein AJ. Campbell-Walsh Urology. 9th ed. Philadelphia, PA: WB Saunders; 2007: Chapter 88.

Gilling P, Mackey M, Cresswell M, et al. Holmium laser versus transurethral resection of the prostate: a randomized prospective trial with 1-year follow up. J Urol.1999;162 (5):1640-1644.

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

Gilling PJ, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. Mar 2019; 125: 169-173. 

Gilling P, Barber N, Bidair M, et al. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. Feb 2020; 27(1): 10072-10079.

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.

Hoffman RM, MacDonald R, Wilt TJ. Laser prostatectomy for benign prostatic obstruction. Cochrane Database of Sys Rev. 2004;1:CD001987.

Hoffman RM, Monga M, Elliot SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Sys Rev.2007;Oct 14;(4):CD004135.

Kuang M, Vu A, Athreya S. A systematic review of Prostate Artery embolization in the treatment of symptomatic benign prostatic hyperplasia. Cardiovasc Intervent Radiol. 2017 May; 40(5):655-663.

Kuntz R, Lehrich K. Transurethral holmium laser enucleation versus transvesical open enucleation for prostate adenoma greater that 100 gm: a randomized prospective trial of 120 patients. J Urol.2002;168(4 Pt 1):1465-1469.

Larson TR. Rationale and assessment of minimally invasive approaches to benign prostatic hyperplasia therapy. Urology. 2002;59(2 Suppl 1):12-16.

Liedberg F, Adell L, Hagberg G, Palmqvist IB. Interstitial laser coagulation versus transurethral resection of the prostate for benign prostatic enlargement: a prospective randomized study. Scand J Urol Nephrol. 2003;37(6):494-497.

Kursh ED, Concepcion R, Chan S, et al. Interstitial laser coagulation versus transurethral prostate resection for treating benign prostatic obstruction: a randomized trial with 2-year follow-up. Urology. 2003;61(3):573-578.

McVary KT. Clinical evaluation of benign prostatic hyperplasia. [National Center for Biotechnology Information (NCBI) Web site]. 2003. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1502354/. Accessed January 31, 2022.
McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective 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. 

McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. Jan 2018; 111: 1-9.

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 Randomized Controlled Study. Urology. Apr 2019; 126: 171-179. 

McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. Apr 19 2021.

Mottet N, Anidjar M, Bourdon O, et al. Randomized comparison of transurethral electroresection and Holmium:YAG laser vaporization for symptomatic benign prostatic hyperplasia. J Endourol.1999;13(2):127-130.

Montorsi F, Naspro R, Salonia A, et al. Holmium laser enucleation versus transurethral resection of the prostate: results from a 2-center, prospective, randomized trial in patients with obstructive benign prostatic hyperplasia. J Urol. 2008;179(5 Suppl):S87-S90.

Muruve NA, Steinbecker K, Willard TB. Transurethral needle ablation of the prostate (TUNA). [eMedicine Web site]. 04/04/17 Available at:http://www.emedicinemedscape.com/article/449477-overview. Accessed January 31, 2019.

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.

Naspro R, Bachmann A, Gilling P, et al. A review of the recent evidence (2006-2008) for 532-nm photoselective laser vaporization and holmium laser enucleation of the prostate. Eur Urol.2009;56(6):1345-1357.

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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 Feb 23, 2022.
Neotract Inc. Urolift--BPH Relief In Sight. 2012. Available at: https:/www.urolift.com/physicians/procedure-device. Accessed January 31, 2019.

Novitas Solutions. Local Coverage Determination(L36775). Prostatic Urethral Lift (PUL) [Novitas Solutions Web site]. Original: 10/30/2016 (Retired 04/03/2020). Available at:https://localcoverage.cms.gov/mcd_archive/view/lcd.aspx?lcdInfo=36775:21. Accessed March 01, 2022.

Novitas Solutions, Inc. Local Coverage Article(A55477). Rezum System for use in the management of benign prostatic hypertrophy clarification regarding the system technology and correct billing (article). [Novitas Solutions Web site]. 03/17/2017. Revised : 03/10/2022. Available at: https://www.cms.gov/medicare-coverage-database/license/cpt-license.aspx?from=~/overview-and-quick-search.aspx&npage=/medicare-coverage-database/details/article-details.aspx&articleId=55477&ver=2&Date=11/26/2018&SearchType=Advanced&ContrId=&DocID=A55477&bc=JAAAABgAAAAA&. Accessed March 11, 2022.

Planz B, Kalem T, Sprenger C, et al. A prospective randomized study of combined visual laser ablation and transurethral resection of the prostate versus transurethral prostatectomy alone. Urol Int. 2003;71(1):26-30.

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.

Pyo JS, Cho WJ. Systematic review and meta-analysis of prostatic artery embolization for lower urinary tract symptoms related to benign prostatic hyperplasia. Clin Radiol. 2017 Jan; 72(1):16-22.

Ruszat R, Wler 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):1432-1439.

Schorsch I, Muschter R, Danielli L, et al. Two year follow-up of a multi-center clinical study using water-induced thermotherapy for BPH. Paper presented at: American Urological Association Annual Meeting; May 2, 2000; Atlanta, GA.

Sonksen J, Barber NJ, et al. Prospective randomized, multinational study of prostatic rethral lift versus transurethral resection of the prostate: 12-month results from the BPH-6 study. Eur Urol. 2015 October; 68(4):643-652. Available at: https://www.ncbi.nlm.nih/gov/pubmed/25937539. Accessed Feb 23, 2022.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

0421T 
52441
52442
52450
52601
52630
53850
53854
55821
55831

THE FOLLOWING CODE IS USED TO REPRESENT HOLMIUM LASER ABLATION OF THE PROSTATE (HoLAP), PHOTOSELECTIVE VAPORIZATION (PVP), and TRANSURETHRAL ELECTROVAPORIZATION OF THE PROSTATE (TUVP):

52648 

THE FOLLOWING CODE IS USED TO REPRESENT HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HoLEP) and HOLMIUM LASER RESECTION OF THE PROSTATE (HoLRP):

52649


NOT MEDICALLY NECESSARY

THE FOLLOWING CODE IS USED TO REPRESENT VISUAL LASER ABLATION OF THE PROSTATE (VLAP) AND INTERSTITIAL LASER COAGULATION (ILC):

52647

THE FOLLOWING CODES ARE USED TO REPRESENT TRANSURETHRAL ULTRASOUND-GUIDED LASER-INDUCED PROSTATECTOMY (TULIP):

52648
52649 

THE FOLLOWING CODES ARE USED TO REPRESENT WATER-INDUCED THERMOTHERAPY (WIT) OF THE PROSTATE:

53899
53852 

EXPERIMENTAL/INVESTIGATIONAL

0714T 
37243

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL BALLOON DILATION OF THE PROSTATE:

53899

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL ETHANOL ABLATION OF THE PROSTATE (TEAP):

53899

THE FOLLOWING CODE IS USED TO REPRESENT HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) OF THE PROSTATE:

53899 ​

ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms

N40.3 Nodular prostate with lower urinary tract symptoms
HCPCS Level II Code Number(s)
Healthcare Common Procedure Coding System (HCPCS) C Series Codes can only be reported for outpatient facility services. Professional providers should not report HCPCS C Series Codes for professional services regardless of where those services are performed.

MEDICALLY NECESSARY

C2596 Probe, image-guided, robotic, waterjet ablation  ​
C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants

C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

7/1/2022
7/1/2022
11.17.06
Medical Policy Bulletin
Commercial
No
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