Medical Policy: 07.01.69 

Original Effective Date: July 2015 

Reviewed: June 2017 

Revised: June 2017 

 

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 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:

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

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) 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.

 

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:

 

  • Current evidence on the efficacy and safety of insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. During the consent process clinicians should, in particular, advise patients about the range of possible treatment options and the possible need for further procedures if symptoms recur. NICE encourages further research and publication of results from consecutive case series of patients having this procedure.
  • 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 up to 5 years.

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

Using the PlasmaKinetic™ Tissue Management System: The PlasmaKinetic™ Tissue Management System 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 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 (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:

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:

  • Transurethral ultrasound-guided laser induced prostatectomy (TULIP)
  • Water-induced thermotherapy WIT (also known as hot-water balloon thermoablation and thermourethral hot-water therapy).
  • Transurethral ethanol ablation of the prostate (TEAP)

The following laser procedures are considered investigational for all genitourinary conditions other than BPH:

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

 

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)
  • 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)
  • 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
  • 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) deny always

 

Selected References:

  • ECRI Institute.
  • 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 External Site(FDA). 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 External Site(NICE). Interventional procedure guidance 453. Prostate artery embolization for benign prostate hyperplasia. April 2013.
  • Society of Interventional Radiology External Site(SIR). 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

 

Policy History:

  • 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.