Medical Policy: 07.01.69
Original Effective Date: July 2015
Reviewed: June 2017
Revised: June 2017
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.
Benign prostatic hyperplasia, or BPH, develops from excessive cell proliferation in the prostate. 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. The AUA 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:
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 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.
The current American Urology Association (AUA) Guideline on the Management of BPH (2010) does not address the use of PUL for the treatment of BPH. An interventional procedure guidance for PUL for BPH published by NICE (2014) includes the following recommendations:
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".
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.”
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 (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.
Using the PlasmaKinetic™ Tissue Management System: The PlasmaKinetic™ Tissue Management System uses plasma energy to vaporize tissue with minimal thermal spread.
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) 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 jet tissue resection (ie, AquaBeam) is being explored as a way to excise tissue from the prostate and to cauterize the excised area without the use of heat. The water jet is guided robotically using transrectal ultrasound imaging. FDA approval has not yet been granted and clinical trials are in progress.
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:
For treatment of BPH with High Intensity Focused Ultrasound (HIFU) see medical policy 02.01.53
The Prostatic UroLift (PUL), also known as the UroLift system or the transprostatic implant system is considered investigational.
Placement of temporary prostatic stents is considered investigational for all indications including, but not limited to, treatment of BPH, following surgical treatment of BPH, prostate cancer, or radiation therapy.
Endoscopic balloon dilation of the prostatic urethra for the treatment for BPH is considered investigational.
Prostatic arterial embolization (PAE) for the treatment for BPH is considered investigational.
Cryosurgical ablation for the treatment for BPH is considered investigational.
Plasma Kinetic Vaporization for the treatment for BPH is considered investigational.
Aquablation/transurethral waterjet ablation for the treatment of BPH is considered investigational.
The following treatments are considered investigational as treatment for BPH:
The following laser procedures are considered investigational for all genitourinary conditions other than BPH:
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), Prostatic UroLift (PUL), aquablation of the prostate, cryosurgical ablation, plasma kinetic vaporization, and temporary prostatic stents, are needed to determine their long-term efficacy and superiority compared to standard treatments for BPH. Due to limitations with the major RTC trials, results do not definitively demonstrate the noninferiority of PUL to TURP; more evidence is needed to corroborate these results. The available evidence of efficacy is weak and heavily biased at this time.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.
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