Medical Policy: 07.01.69 

Original Effective Date: July 2015 

Reviewed: February 2018 

Revised: February 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Benign prostatic hyperplasia, or BPH, develops from excessive cell proliferation in the prostate. The enlarged gland has been proposed to contribute to the overall lower urinary tract symptoms (LUTS) complex via at least two routes: (1) direct bladder outlet obstruction from enlarged tissue and (2) from increased smooth muscle tone and resistance within the enlarged gland. The associated chronic bladder-outlet obstruction often leads to signs and symptoms. The frequent symptoms of BPH include: urinary retention, urinary frequency, incomplete bladder emptying, gross hematuria (visible blood in the urine), and renal insufficiency.

 

A questionnaire is often used to evaluate the severity of the condition. Several scoring systems have been developed to assess the subjective symptoms of BPH, including the American Urological Association (AUA) symptom index (SI). The AUA-SI test contains seven questions, and the resulting symptom score is from mild to severe. Each question is answered with a score ranging from 0 for none to 5 for severe. The symptom score (i.e., sum of the answers) is ranked as follows:

  • Mild prostatism (0 to 7)
  • Moderate prostatism (8 to 19)
  • Severe prostatism (20 to 35)

 

Lower urinary tract symptoms (LUTS) secondary to BPH (LUTS/BPH) is not often a life-threatening condition, the impact of LUTS/BPH on quality of life can be significant. The prevalence of LUTS increases with age, the burden and number of men complaining of LUTS will rise with the increasing life expectancy and growth of our elderly population. The treatment options include watchful waiting, medical, surgical, or minimally invasive surgical treatments.

 

If the patient has no polyuria and medical treatment is considered, the physician can proceed with therapy by focusing initially on modifiable factors such as concomitant drugs, regulation of fluid intake (especially in the evening), lifestyle (increasing activity) and diet (avoiding excess of alcohol and highly seasoned or irritating foods).

 

If pharmacological treatment is necessary, it is recommended that the patient be followed to assess treatment success and possible adverse events. The time from initiation of therapy to treatment assessment varies according to the pharmacological agent prescribed. This time frame can be as short as 3 weeks and as long as 3 months.

 

There are guidelines for the overall treatment of BPH from both the American Urological Society and The European Association of Urology, the key recommendations are noted below.

 

American Urological Association, Management of Benign Prostatic Hyperplasia

Per the American Urological Association guideline (2014):

  • Patients with mild symptoms of LUTS secondary to BPH (AUA-SI score <8) and patients with moderate or severe symptoms (AUA-SI score ≥8) who are not bothered by their LUTS should be managed using a strategy of watchful waiting (active surveillance).
  • Anticholinergic agents are appropriate and effective treatment alternatives for the management of LUTS secondary to BPH in men without an elevated post-void residual and when LUTS are predominantly irritative.
  • Alfuzosin, doxazosin, tamsulosin, and terazosin are appropriate and effective treatment alternatives for patients with bothersome, moderate to severe LUTS secondary to BPH (AUA-SI score ≥8). Although there are slight differences in the adverse events profiles of these agents, all four appear to have equal clinical effectiveness.
  • 5-Alpha-reductase Inhibitors (5-ARIs) may be used to prevent progression of LUTS secondary to BPH and to reduce the risk of urinary retention and future prostate-related surgery.

 

European Association of Urology (2017)

In 2017, the European Association of Urology updated its guidelines. The recommendations with grades A from the guideline include:

  • Renal function assessment must be performed if renal impairment is suspected, based on history and clinical examination or in the presence of hydronephrosis or when considering surgical treatment for male LUTS.
  • Urethrocystoscopy should be performed in men with LUTS to exclude suspected bladder or urethral pathology and/or prior to minimally invasive/surgical therapies if the findings may change treatment.
  • Offer men with mild/moderate symptoms, minimally bothered by their symptoms, watchful waiting.
  • Offer men with LUTS lifestyle advice prior to or concurrent with treatment.
  • Offer a1-blockers to men with moderate-to-severe LUTS.
  • Offer 5α-reductase inhibitors to men who have moderate-to-severe LUTS and an enlarged prostate (> 40 mL).
  • Offer combination treatment with an α1-blocker and a 5α-reductase inhibitor to men with
    moderate-to-severe LUTS and risk of disease progression (e.g. prostate volume > 40 mL).
  • Use combination treatment of an α1-blocker with a muscarinic receptor antagonist in patients with moderate-to-severe LUTS if relief of storage symptoms has been insufficient with monotherapy with either drug.
  • TURP is the current surgical standard procedure for men with prostate sizes of 30-80 mL and bothersome moderate-to-severe LUTS secondary of BPO. TURP provides subjective and objective improvement rates superior to medical or minimally invasive treatments.
  • TUIP (transurethral incision of the prostate) is the surgical therapy of choice for men with prostate sizes < 30 mL, without a middle lobe, and bothersome moderate-to-severe LUTS secondary to BPO.
  • OP (open prostatectomy) or EEP (endoscopic enucleation of the prostate) such as holmium laser or bipolar enucleation are the first choice of surgical treatment in men with a substantially enlarged prostate (e.g. > 80 mL) and moderate-to-severe LUTS.
  • Durability is in favor of TURP which has lower re-treatment rates compared to TUMT (transurethral microwave therapy)
  • TUNA™ is a minimally invasive alternative with decreased morbidity compared to TURP but with less efficacy.
  • Durability is in favor of TURP with lower re-treatment rates compared to TUNA™
  • HoLEP (holmium laser enucleation) and 532-nm laser vaporisation of the prostate are alternatives to TURP in men with moderate-to-severe LUTS leading to immediate, objective, and subjective improvements comparable with TURP
  • ThuVaRP (Tm:YAG vaporesection) is an alternative to TURP for small- and medium-size prostates.
  • Prostatic urethral lift (Urolift®) leads to objective and subjective short- and mid-term improvements. RCTs with longer follow-up are required.
  • The guideline urethral lift implants, giving a grade B recommendation for the use of Urolift in men with lower urinary tract symptoms who had prostates < 70 mL with no middle lobe and were interested in preserving ejaculatory function. It noted that “long term effects have not been evaluated.”
Male LUTS High Risk Patient
Can have surgery under anesthesiaCannot have surgery under anesthesia
Can stop anticoagulations/antipalatelet therapy Cannot stop anticoagulations/antipalatelet therapy TUMT
TUNA
PU life
Stent
Qualifies as Low Risk Patient Laser Vaporisation (1)
Laser enulcleation
Male LUTS Low Risk Patient
Prostate Volume < 30 mlProstate Volume 30-80 mlProstate Volume >80 ml
TUIP (1)
TURP
TURP (1)
Laser enucleation
Bipolar enucleation
Laser vaporisation
PU lift
TUMT
TUNA
Open prostatectomy (1)
HoLEP (1)
Bipolar enucleation
Laser vaporisation
Thulium enucleation
TURP

 

(1) Current standard/first choice. The alternative treatments are presented in alphabetical order.

Notice: Readers are strongly recommended to read the full text that highlights the current position of each treatment in detail.

 

Agency for Health Care Policy and Research

According to the Agency for Health Care Policy and Research guidelines for the diagnosis and treatment of BPH and the recommendations of the Second International Consultation on Benign Prostatic Hypertrophy, the absolute indications for primary surgical management of BPH are as follows:

  • Refractory urinary retention
  • Recurrent urinary tract infections due to prostatic hypertrophy
  • Recurrent gross hematuria
  • Renal insufficiency secondary to bladder outlet obstruction
  • Bladder calculi
  • Permanently damaged or weakened bladders
  • Large bladder diverticula that do not empty well secondary to an enlarged prostate

 

The National Institute for Health and Care Excellence (NICE)

The National Institute for Health and Care Excellence (NICE) published a technical guidance on prostatic lift procedures in 2016. NICE performed a literature search and data synthesis to support the development of the guidance. Studies selected were the same studies included in Perera et al (2015), except for the exclusion of Hoffman et al (2012) and the inclusion of Garrido Abad et al (2013) in the analysis. Comparators for the review were transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). When the literature search was performed, there were no studies directly comparing PUL with either TURP or HoLEP. Therefore NICE extracted data from a TURP vs HoLEP systematic review to perform a “pragmatic indirect comparison” of these comparators with prostatic lift procedures. Reviewers concluded that while PUL provided a significant improvement in IPSS, BPH-II, and quality of life, those improvements were smaller than those seen with TURP or HoLEP; however, it should be noted that the PUL procedure was associated with a slight improvement in erectile or ejaculatory function.

 

Treatment Options

Watchful waiting

BPH/LUTS needs to be treated only if:

  • The symptoms are severe enough to bother you OR
  • Your urinary tract is seriously affected.

 

An enlarged prostate alone is not reason enough to get treatment. Your prostate may not get bigger than it is now, and your symptoms may not get worse. Watchful waiting is not an active treatment like taking medicine or having surgery. It means getting regular exams to see if your BPH is getting worse or causing problems. Without treatment, BPH symptoms may get better, stay the same, or get worse.

 

Many men with LUTS are not troubled enough by their symptoms to need drug treatment or surgical intervention. All men with LUTS should be formally assessed prior to any allocation of treatment in order to establish symptom severity and to differentiate between men with uncomplicated (the majority) and complicated LUTS. Watchful waiting is a viable option for many men with non-bothersome LUTS as few will progress to AUR and complications (e.g. renal insufficiency or stones), whilst others can remain stable for years. In one study, approximately 85% of men with mild LUTS were stable on WW at one year.

 

Management with Medication

Medications for management of BPH should be the first line treatment in those that have bothersome symptoms but lack indications for immediate surgical intervention.

 

α1-blockers aim to inhibit the effect of endogenously released noradrenaline on smooth muscle cells in the prostate and thereby reduce prostate tone and bladder outlet obstruction. α1-adrenoceptors located outside the prostate (e.g. urinary bladder and/or spinal cord) and α1-adrenoceptor subtypes (α1B- or α1D-adrenoceptors) may play a role as mediators of effects. α1-adrenoceptors in blood vessels, other non-prostatic smooth muscle cells, and the central nervous system may mediate adverse events.

 

α1-blockers currently available are: alfuzosin hydrochloride (alfuzosin); doxazosin mesylate (doxazosin); silodosin; tamsulosin hydrochloride (tamsulosin); terazosin hydrochloride (terazosin).

 

5-Alpha-reductase Inhibitors (5-ARIs) may be used to prevent progression of LUTS secondary to BPH and to reduce the risk of urinary retention and future prostate-related surgery. There is evidence that prostate size can decrease by 20% at this stage and the risk for acute urinary retention is decreased by 50% after 4 years of therapy.

 

Surgery

By itself, an enlarged prostate does not mean you need surgery. An enlarged prostate may not become larger. Also, no operation for BPH lowers the chance of getting prostate cancer in the future. Surgery may be indicated when medications fail to halt or improve bothersome symptoms of LUTS.

 

Surgery is generally recommended, as a first line treatment, for men with certain problems. These include:

  • Not being able to urinate at all.
  • Urine backup into the kidneys that damages the kidneys.
  • Frequent urine infection.
  • Major bleeding through the urethra caused by BPH.
  • Stones in the bladder.

 

Surgery without these indications is considered a second-line treatment after medication use.

 

TURP remains the gold standard for surgical correction of BPH. The studies have shown that although other surgeries are less invasive, the TURP and HoLEP laser have the best outcomes for relieving symptoms of BPH.

  • Transurethral needle ablation of the prostate (TUNA) is an appropriate and effective treatment alternative for bothersome moderate or severe LUTS secondary to BPH.
  • Transurethral Microwave Thermotherapy (TUMT) is effective in partially relieving LUTS secondary to BPH and may be considered in men with moderate or severe symptoms.
  • Transurethral laser enucleation (holmium laser resection of the prostate [HoLRP], holmium laser enucleation of the prostate [HoLEP]), transurethral side firing laser ablation (holmium laser ablation of the prostate [HoLAP], and photoselective vaporization [PVP]) are appropriate and effective treatment alternatives to transurethral resection of the prostate and open prostatectomy in men with moderate to severe LUTS and/or those who are significantly bothered by these symptoms.

 

Transurethral resection of the prostate (TURP)

Transurethral resection of the prostate (TURP) is the gold standard for moderate to severe BPH, which does not respond to medical treatment. TURP involves an endoscopically guided surgical excision of prostate tissue using a cystoscope and electrodissection. The cystoscope is inserted up the urethra to remove prostate tissue that is blocking urine flow.

 

Transurethral Microwave Thermography (TUMT)

Transurethral microwave thermotherapy (TUMT) is a minimally invasive BPH treatment that uses heat to ablate obstructive prostatic tissue and reduce symptoms of the condition. This treatment often is used in patients who no longer respond to medication. During treatment, microwaves, which are radio waves varying from 1 mm to 30 cm in length, are delivered to the prostate via a probe inserted into the gland through the urethra. Intraprostatic temperature is monitored during microwave thermotherapy to reduce the risk for damage to surrounding structures. Following the procedure, patients usually require catheterization to prevent urinary retention.

 

Transurethral Needle Ablation (TUNA)

TUNA is performed by placing interstitial radiofrequency (RF) needles through the urethra and into the lateral lobes of the prostate, causing heat-induced coagulation necrosis. The tissue is heated to 110°C at an RF power of 456 kHz for approximately 3 minutes per lesion. The ideal patient for TUNA is thought to be a man with obstructive symptoms and a prostate of 60 g or less with predominantly lateral lobes. TUNA results report a high retreatment rate at 20 months follow-up.

 

The manufacturer lists the following contraindications to TUNA therapy:

  • Active urinary tract infection
  • Neurogenic, decompensated, or atonic bladder
  • Urethral strictures or muscle spasms that prevent insertion of the cartridge sheath
  • Bleeding disorders or patients taking anticoagulation medication unless antiplatelet medication has been discontinued for at least 10 days
  • ASA class group V patients (A moribund patient who is not expected to survive without the operation)
  • Clinical or histological evidence of prostatic cancer or bladder cancer
  • Prostate gland that is less than 34 mm or greater than 80 mm in transverse diameter
  • Presence of any prosthetic device in a region that may interfere with the procedure
  • Patients whose prostate has previously been treated with nonpharmacologic therapies
  • Presence of cardiac pacemaker, implantable defibrillator, or penile implants
  • Patients with any component(s) of an implantable neurostimulation system

 

Transurethral enucleation of the prostate (TUEP)

TUEP is a surgical procedure a spatula attached to a tungsten wire loop is used to dissect between the surgical capsule and adenoma by enucleation.

 

Transurethral incision of the prostate (TUIP)

TUIP is a surgical procedure where a resectoscope is inserted through the tip of the penis into the urethra. One or two grooves are cut into the bladder 1neck to open the urinary channel, allowing urine to pass more easily.

 

Transurethral vaporization of the prostate (TUVP)

TUVP is a surgical procedure which utilizes a loop electrode or grooved roller electrode which is attached to a resectoscope that applies heat from high-voltage electric current ablating obstructive prostatic tissue and sealing the surrounding blood vessels.

 

Laser Therapies

Laser prostatectomy and laser based procedures including contact laser ablation of the prostate (CLAP), holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP), photoselective laser vaporization (PVP), transurethral ultrasound-guided laser induced prostatectomy (TULIP), and visually-guided laser ablation of the prostate (VLAP) are minimally invasive techniques for management of BPH, when medications fail to improve symptoms. The current higher powered lasers—holmium laser, thulium laser, green light laser and diode laser—are able to ablate prostatic tissue rapidly. Holmium laser is optimized for incision, and green light laser is optimized for vaporization.

 

There is currently insufficient high-quality, comparative evidence to support the routine adoption of laser therapies in high-risk patients, that is those who:

  • have an increased risk of bleeding or
  • have prostates larger than 100 ml or
  • have urinary retention.

 

The Prostatic UroLift (PUL) Procedure (52441, 52442, C9739, C9740)

The Prostatic UroLift (PUL), also known as the UroLift system or the transprostatic implant system has been researched for a less invasive procedure to manage BPH. The UroLift System received FDA authorization for marketing through a de novo classification approval on September 13, 2013 (K130651), as a Class II device. It is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above, with contraindications noted.

 

The PUL procedure consists of small permanent transprostatic implants, made with common implantable materials, (i.e., nitinol, stainless steel, and PET suture), placed cystoscopically to compress the prostate tissue, therefore increasing the urethral lumen and reducing obstruction to urine flow. Subsequently, 4 or 5 implants are delivered into the prostatic urethra to maintain urethral patency. A final cystoscopy confirms that the implants were appropriately positioned. The bladder is filled at the end of the procedure and the patient voids. This technique is proposed as an option for geno typical men who are poor candidates for more invasive procedures.

 

National Institute for Health and Care Excellence (2014)

A medical technology guidance was completed (2015) and includes the following conclusions:

 

The Committee concluded that the UroLift system is effective in relieving symptoms of benign prostatic hyperplasia. It noted that the degree of symptom relief outcomes is slightly less than that after transurethral resection of the prostate (TURP) or holmium laser enucleation (HoLEP), but it is sufficient and clinically important. The Committee recognised that the duration of symptom relief after using the UroLift system is uncertain. It concluded that it is similar in the medium term (up to 3 years) to the comparators but that further evidence on durability and the need for subsequent procedures would be useful.

 

The Committee considered the evidence that the UroLift system does not damage sexual function to be convincing. This contrasts with a substantial risk to erectile and ejaculatory function after TURP or HoLEP and represents a significant advantage for men who wish to preserve their sexual function.

 

The Committee noted that evidence for avoiding catheterisation after the UroLift system was sparse, but accepted expert advice that catheterisation time would be reduced and in many cases catheterisation would be avoided, especially as surgeons gain experience with the procedure. It also concluded that it was reasonable and likely that the UroLift system would be used as a day‑surgery procedure, often under local anaesthetic.

 

Based on the day–surgery scenario in the cost model, and assuming a maximum of 4 implants are used, the Committee concluded that using the UroLift system is likely to be cost saving compared with TURP. However, the Committee also concluded that at the current costs of implants, using the system in an inpatient setting was likely to be more costly than either TURP or HoLEP.

 

The prostatic UroLift is a less invasive option to existing BPH treatments. The short term outcomes at 2 years note improvement in urinary symptoms and flow, with preserved sexual function. However, there are no long-term studies, which are necessary to determine the safety and efficacy of these implants, as well as the duration of benefits and the need for further procedures. There are a few ongoing Clinical Trials and studies that will continue to evaluate the Prostatic UroLift (PUL) procedure past 5 years.

 

Investigative Surgical Procedures

Temporary Prostatic Stents (53855)

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."

 

According to the guidelines by the American Urological Association "because prostatic stents are associated with significant complications, such as encrustation, infection and chronic pain, their placement should be considered only in high-risk patients, especially those with urinary retention".

 

Balloon Dilation of the Prostate (53899)

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. The 4th International Consultation on BPH has rated balloon dilation as an unacceptable treatment option since 1995. The Guideline states “Balloon dilation is not recommended as a treatment option for patients with symptoms of BPH.”

 

Prostatic Arterial Embolization, transcatheter embolization (37242)

In this procedure, the interventional radiologist will thread a tiny catheter through the artery in the groin to the arteries supplying blood to the prostate gland. The RIA Endovascular physician will then embolize, or cut off the blood flow to the prostate gland. The decreased blood flow causes the prostate gland to shrink, which helps to decrease the size of the prostate gland.

 

A National Institute for Health and Care Excellence interventional procedure guidance for prostatic arterial embolization 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.

 

Cryosurgical ablation (55873)

Cryosurgical ablation (cryoablation or cryosurgery) involves exposing tissues to extreme cold in order to produce well-demarcated areas of cell injury and destruction. The tissue is usually cooled below -20 degrees C. The cold is usually produced by use of a probe containing liquid nitrogen. Cryosurgical ablation may be performed as an open surgical technique, percutaneously, or laparoscopically with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.

 

Cryosurgical ablation, although the gold standard for prostate cancer, does not have proven efficacy in the treatment of benign prostatic hyperplasia.

 

Plasma Kinetic Vaporization (PKVP) (button TURP)

Plasma Kinetic Vaporization (i.e.The PlasmaKinetic™ Tissue Management System, PlasmaButton™, also called 'button TURP') uses plasma energy to vaporize tissue with minimal thermal spread.

 

Aquablation (water-jet hydrodissection) (0421T)

The Aquablation System delivers a high-velocity saline stream (the AquaBeam®) under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. Using the real-time transrectal ultrasound image and an integrated planning station, the target region for excision is registered within the prostate and the target tissue contour and depth are programmed by the surgeon.

 

Transurethral ultrasound-guided laser induced prostatectomy (TULIP)

Transurethral ultrasound guided laser induced prostatectomy (TULIP) is similar to transurethral incision of the prostate (TUIP) except that cuts are made with a laser. Laser energy is delivered under ultrasound guidance, producing tissue necrosis.

 

Water-induced thermotherapy (also known as hot-water balloon thermoablation and thermourethral hot-water therapy)

Water-induced thermotherapy (i.e Rezūm System) delivers sterile water vapor (steam) transurethrally directly into hyperplastic tissue. Heat is released as the vapor condenses, causing cell death. The tissue is then either excreted through urine or reabsorbed in the body. The ongoing trials are not assessing how well the Rezūm System compares to other minimally invasive treatments for BPH, so no data are forthcoming to address the key question of comparative effectiveness.

 

Laser Treatment (52647, 52648, 52649)

Laser treatment has become an alternative to open prostatectomy for the treatment of benign prostatic hyperplasia (BPH). 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)
  • 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)
  • Interstitial laser coagulation of the prostate (ILCP)
  • Photoselective laser vaporization of the prostate (PVP)
  • Transurethral ultrasound guided laser induced prostatectomy (TULIP)
  • Visually guided laser ablation of the prostate (VLAP), also called non-contact laser ablation of the prostate

 

For treatment of BPH with High Intensity Focused Ultrasound (HIFU) see medical policy 02.01.53

 

Prior Approval:

 

Not applicable

 

Policy:

For any interventional procedures to be considered medically necessary for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) there must be moderate or severe symptoms (AUA-SI score ≥8).

 

For any interventional procedures to be considered medically necessary for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) there must be either 1.) Indications for first line treatment as noted below or 2.) Failure of medication management for 6 months.

 

Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (eg, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (eg, finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (eg, darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (eg, tadalafil).

 

Medication would be considered first line treatment for all individuals that do not have the indications for immediate surgery as mentioned below.

 

Procedural Intervention

Laser therapies and surgical procedures noted below are considered medically necessary as a first line treatment only when one of the following symptoms are present:

  • Not being able to urinate at all/ severe urinary retention or
  • Urine backup into the kidneys that damages the kidneys or
  • Frequent urinary tract infections (a minimum of 2 infections over the last 6 months) or
  • Major bleeding through the urethra caused by BPH or
  • Bladder calculi (stones)
  • Permanently damaged or weakened bladders
  • Large bladder diverticula that do not empty well secondary to an enlarged prostate

 

Surgical procedures below may be medically necessary as a second line treatment when patients have had insufficient relief in LUTS or post-void residual after consistent pharmacological therapy of 6 months:

  • Open/laparoscopic prostatectomy 55801, 55821, 55831
  • Transurethral resection of prostate, TURP (52601, 52630)
  • Transurethral needle ablation (TUNA) (53852)
  • Transurethral electrovaporization (TUVP, TVP, TUEP), also known as transurethral vapor resection of the prostate (TUVRP) (52648)
  • Transurethral destruction of prostate tissue; by microwave thermotherapy (TUMT) (53850)
  • Transurethral incision of the prostate (TUIP) (52450)

 

Minimally Invasive Procedures

Several minimally invasive prostate ablation procedures have been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, prostatic lift, and photoselective vaporization of the prostate. The minimally invasive procedures were individually compared with transurethral resection of the prostate at the time they were developed, which provided a general benchmark for evaluating those procedures.

 

Urolift

Use of prostatic urethral lift in individuals with moderate-to-severe (AUA-SI score ≥8) lower urinary tract obstruction due to benign prostatic hyperplasia may be considered medically necessary when all of the following criteria are met:

  • Patient has persistent or progressive lower urinary tract symptoms per AUA-SI score, (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months.
  • Prostate gland volume is ≤80 mL.
  • Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe.
  • Patient does not have urinary retention, frequent urinary tract infections, or recent prostatitis (within past year).
  • Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer. Performed within 12 months of the procedure.
  • Patient does not have a contact dermatitis nickel allergy.

 

Use of prostatic urethral lift in other situations is considered investigational.

 

Use of prostatic urethral lift outside of the above criteria is considered investigational because the population has not been sufficiently studied.

 

While the UroLift system has demonstrated clear strengths, specifically maintaining sexual function, it has limitations such as: the exclusion of patients with obstructive median lobes, the elimination of patients with larger prostate volumes and a history of urinary retention that eliminates a large proportion of patients. The conclusion of review is that the evidence is very low due to a small number of patients included in studies and that larger trials are needed to answer the question on comparative efficacy for PUL with other minimally invasive therapies. The long term cost effectiveness of PUL can be shown at this time up to five years when 4 or less implants are used per NICE cost-comparison. ECRI found the overall evidence of literature to be low or very low quality for all current trials comparing prosthetic urethral lift to transurethral resection of the prostate. The literature overall as a body of evidence maintain TURP and HoLEP laser as the gold standards for interventional treatment. That noted, prostatic urethral lift may be a minimally invasive solution for those concerned about sexual function side effects and the recovery time of other procedures.

 

Laser Therapies

The following laser procedures are considered medically necessary for BPH/LUTS after a 6 month trial of medication management for those with moderate to severe symptoms (AUA-SI score ≥8):

  • Contact laser ablation of the prostate (CLAP); (52648) or
  • Holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP); (52649) or
  • Interstitial laser coagulation of the prostate (ILCP); or
  • Photoselective laser vaporization of the prostate (PVP)(52648) or
  • Visually guided laser ablation of the prostate (VLAP) (52647, 52648), also called non-contact laser ablation of the prostate

 

These therapies are considered investigational for all other genitourinary conditions.

 

Miscellaneous Investigational Treatments

Placement of temporary prostatic stents (53855)is considered investigational for all indications including, but not limited to, treatment of BPH/LUTS, following surgical treatment of BPH, prostate cancer, or radiation therapy.

 

The following procedures are considered investigational:

  • Endoscopic balloon dilation of the prostatic urethra
  • Prostatic arterial embolization (PAE)
  • Cryosurgical ablation for the treatment for BPH
  • Plasma Kinetic Vaporization (e.g., PlasmaKinetic™ Tissue Management System)
  • Aquablation/transurethral waterjet ablation (e.g. AquaBeam System)
  • Water-induced thermotherapy (WIT)(also known as hot-water balloon thermoablation and thermourethral hot-water therapy)
  • Water vapor thermal therapy (e.g., Rezum System)
  • Absolute ethanol injections.
  • High-intensity focused ultrasound (HIFU) for benign prostatic hyperplasia (BPH)
  • Histotripsy (Vortx Rx System)
  • Interstitial laser coagulation (ILC)
  • Transrectal thermal therapy
  • Transurethral ultrasound-guided laser incision of the prostate (TULIP)

 

The American Urology Association’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.

 

Trials comparing minimally invasive treatments, including Prostatic arterial embolization (PAE), aquablation of the prostate, cryosurgical ablation, water-induced thermotherapy, plasma kinetic vaporization, high-intensity focused ultrasound, transrectal balloon dilation, thermal therapy, interstitial laser coagulation, and temporary prostatic stents, are needed to determine their long-term efficacy and superiority compared to standard treatments for BPH/LUTS.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 37242 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; arterial, other than hemorrhage or tumor
  • 52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant (used for the first implant)
  • 52442 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure)
  • 52450 Transurethral incision of prostate
  • 52601 Transurethral electrosurgical resection of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)
  • 52630 Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)
  • 52647 Laser coagulation of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included if performed)
  • 52648 Laser vaporization of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)
  • 52649 Laser 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)
  • 53850 Transurethral destruction of prostate tissue; by microwave thermotherapy
  • 53852 Transurethral destruction of prostate tissue; by radiofrequency thermotherapy
  • 53855 Insertion of a temporary prostatic urethral stent, including urethral measurement
  • 55873 Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)
  • 53899 Unlisted procedure, urinary system
  • 55801 Prostatectomy, perineal, subtotal (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy)
  • 55821 Prostatectomy (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy); suprapubic, subtotal, 1 or 2 stages
  • 55831 Prostatectomy (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy); retropubic, subtotal
  • 55899 Unlisted procedure, male genital system
  • C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants
  • C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants
  • C9748 Transurethral destruction of prostate tissue; by radiofrequency water vapor (steam) thermal therapy
  • 0421T Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included when performed)

 

Selected References:

  • 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.
  • 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.
  • U.S. Food and Drug Administration (FDA)External Site. New medical device treats urinary symptoms related to enlarged prostate. FDA News. Silver Spring, MD: FDA; September 13, 2013.
  • Fernandes L, Rio Tinto H, Pereira J, et al. Prostatic arterial embolization: Post-procedural follow-up. Tech Vasc Interv Radiol. 2012;15(4):294-299.
  • National Institute for Health and Clinical Excellence (NICE). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. Interventional Procedure Guidance 475. London, UK: NICE; January 2014.
  • Devonec M, Dahlstrand C. Temporary urethral stenting after high-energy transurethral microwave thermotherapy of the prostate. World J Urol. 1998;16(2):120-123.
  • American Urologic Association (AUA), Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170(2 Pt 1):530-547. Revised 2010.
  • National Institute for Health and Clinical Excellence (NICE) External Site. Interventional procedure guidance 453. Prostate artery embolization for benign prostate hyperplasia. April 2013.
  • Society of Interventional Radiology (SIR) External Site. 2013 Research Consensus Panel. Prostatic artery embolization for treatment of benign prostatic hyperplasia (BPH).
  • Faber K, deAbreu Al, et al. Image-guided robot-assisted prostate ablation using water jet-hydrodissection: initial study of a novel technology for benign prostatic hyperplasia. J Endourol. 2015 Jan;29(1):63-9.
  • Lebdai S, Delongchamps NB, Sapoval M, et al. Early results and complications of prostatic arterial embolization for benign prostatic hyperplasia. World J Urol. 2015 Aug 15
  • Dixon CM, Rijo Cedano E, Mynderse LA, Larson TR. Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the RezÅ«m(®) system: Evaluation of acute ablative capabilities in the human prostate. Res Rep Urol. 2015;7:13-18.
  • 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. 2016;195(5):1529-1538.
  • Jones P, Rajkumar GN, Rai BP, et al. Medium-term outcomes of Urolift (minimum 12 months follow-up): evidence from a systematic review. Urology. May 18 2016. PMID 27208817
  • Bozkurt A, Karabakan M, Keskin E, et al. Prostatic urethral lift: a new minimally invasive treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urol Int. 2016;96(2):202-206. PMID 26613256
  • Roehrborn CG. Prostatic urethral lift: a unique minimally invasive surgical treatment of male lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urol Clin North Am. Aug 2016;43(3):357-369. PMID 27476128
  • Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. Jun 2017;24(3):8802-8813. PMID 28646935
  • Rukstalis D, Rashid P, Bogache WK, et al. 24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham. BJU Int. Oct 2016;118 Suppl 3:14-22. PMID 27684483
  • Gratzke C, Barber N, Speakman MJ, et al. Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJU Int. May 2017;119(5):767-775. PMID 27862831
  • ECRI Institute, Emerging Technology Report (4/18/2017).
  • Abrams P, Chapple C, Khoury S et al: Evaluation and Treatment of Lower Urinary Tract Symptoms in Older Men. J Urol 2009; 181: 1779.
  • S. Gravas , T. Bach, M. Drake, M. Gacci, C. Gratzke, T.R.W. Herrmann, S. Madersbacher, C. Mamoulakis, K.A.O. Tikkinen European Association of Urology (2016).
  • Cunningham, G., Kadmon, D., (2018) UpToDate, Transurethral procedures for treating benign prostatic hyperplasia.
  • McNichols, T. (2016) Benign prostatic hyperplasia and new treatment options-a critical appraisal of the Urolift system. Med devices (9), 115-123.
  • NICE-cost considerations. Urolift for treating lower urinary tract symptoms of benign prostatic hyperplasia. Medical technologies guidance, 10/10/2017.
  • ECR.I Overview of three devices for treating benign prostatic hyperplasia, Health technology Assessment. November 2016. Ecri.com.
  • Gravas, S., Bach, T., Bachmann, A., et. Al. (2016) EAU Guidelines on management of non-neurogenic male lower urinary tract symptoms (LUTS), incl. benign prostatic obstruction (BPO). European Association of Urology.

 

Policy History:

  • February 2018 - Annual Review, Policy Revised
  • June 2017 - Annual review, Policy revised
  • June 2016 - Annual review, Policy revised
  • July 2015 - New policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.