Notification



Notification Issue Date:



Medical Policy Bulletin


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

Policy #:11.17.06l

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the members' contract.

MEDICALLY NECESSARY

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 needle ablation (TUNA)
    • Transurethral microwave thermotherapy (TUMT)
  • The individual has a diagnosis of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (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 prostate-specific antigen (PSA) blood test that meets both of the following criteria:
    • Given 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 15 cc/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).
  • In addition to the above criteria, if the individual has a diagnosis or history of prostate cancer and meets either of the following criteria:
    • The individual is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required.
    • The individual is clinically in remission as evidenced by a PSA < 1.0 ng/mL.

UroLift for the treatment of urinary outlet obstruction due to BPH is considered medically necessary and, therefore covered if the following criteria are met:
  • The individual 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 15 cc/sec on a voided volume that is greater than 125 cc.
  • The individual's symptoms are caused by enlargement of the lateral lobes of the prostate with no median lobe enlargement present.
  • The individual has normal renal function.
  • The individual has mild to moderate symptoms that are refractory to medication or the individual does not wish to take daily 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 has a PSA blood test that meets both of the following criteria:
    • Given 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
  • In addition to the above criteria, if the individual has a diagnosis or history of prostate cancer and meets either of the following criteria:
    • The individual is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required.
    • The individual is clinically in remission as evidenced by a PSA < 1.0 ng/mL.

NOT MEDICALLY NECESSARY

The use of TUNA, TUMT, HoLAP, HoLEP, HoLRP, PVP,TUVP, and UroLift to treat conditions other than those described above is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of other conditions.
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)

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)
  • Aquablation (water jet-hydrosection).

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 needle ablation [TUNA], transurethral microwave thermotherapy [TUMT]), and surgery (e.g., TURP, laser treatments). If there is minimal bother (i.e., 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 benefit 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.

SURGICAL TREATMENTS

STANDARD SURGICAL TREATMENTS
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. Other standard surgical options include TUIP and open prostatectomy.

THERMAL TREATMENT
Transurethral electrovaporization of the prostate (TUVP) 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 less bleeding-related complications when compared to TURP. Evidence in 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. Various types of laser treatments include:
  • 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. Minimally invasive treatments available include the following:
  • 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 is scheduled for completion in December 2015.
  • Aquablation (water jet-hydrosection)
    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. In 2015, the device's manufacturer received an Investigation Device Exemption (IDE) from the FDA to collect data on safety and effectiveness in the U.S. Currently, there's an on-going prospective multi-center randomized blinded study comparing outcomes observed with aquablation to those observed with TURP in individuals with LUTS. In this pivotal study, the primary endpoints for safety and efficacy will be assessed at 3 and 6 months, respectively, and subjects will be followed out to 3 years to collect long-term clinical data.

References


Agency for Healthcare Research and Quality (AHRQ). Guideline on the management of benign prostatic hyperplasia (BPH). [AHRQ Web site]. January 2010. Available at: http://www.guideline.gov/content.aspx?id=25635&search=bph. Accessed November 02, 2015.

Agency for Healthcare Research and Quality (AHRQ). Treatments for benign prostatic hyperplasia. [Centers for Medicare & Medicaid Services (CMS) Web site]. 08/02/2004. Available at: https://www.cms.gov/determinationprocess/downloads/id39TA.pdf. Accessed November 02, 2015.

American Urological Association (AUA). Clinical guidelines. Management of BPH. Chapter 1: Diagnosis and treatment recommendations. [AUA Web site]. 2010. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=bph. Accessed November 02, 2015.

American Urological Association. Image Guided Robotic Waterjet Ablation (AQUABLATION) of the Prostate: Clinical Experience of a Novel Technology for BPH. [AUA Website]. Available at: https://www.auanet.org/university/abstract_detail.cfm?id=MP3-03&meetingID=15NOLA Accessed February 10, 2016.

American Urological Association (AUA) Foundation. Management of benign prostatic hyperplasia (BPH). [AUA Foundation Urology Health Web site]. January 2011. Available at: http://www.urologyhealth.org/urology/index.cfm?article=144. Accessed November 02, 2015.

Breda G, Isgrò A. Treatment of benign prostatic hyperplasia with water-induced thermotherapy: experience of a single institution. J Endourol. 2002;16(2):123-126.

Bouza C, Lopez T, Magro A, et al. Systematic review and meta-analysis of transurethral needle ablation in symptomatic Benign Prostatic Hyperplasia. BMC Urol.2006;6(1):14.

Boyle P, Robertson C, Vaughan ED, et al. A meta-analysis of trials of transurethral needle ablation for treating symptomatic benign prostatic hyperplasia. BJU Int.2004; 94(1):83-8.

Burke N, Whelan JP, Goeree L, et al. Systematic review and meta-analysis of trasnurethral resection of the prostate versus minimally invasive procedures for the treatment of benign prostatic obstruction. Urology.2010;75(5):1015-1022.

Cimentepe E, Unsal A, Saglam R. Randomized clinical trial comparing transurethral needle ablation with transurethral resection of the prostate for the treatment of benign prostatic hyperplasia: results at 18 months. J Endourol. 2003;17(2):103-107.

Cornell University, Department of Urology. BPH/Natural history. [Cornell University Web site]. 2010. Available at: http://www.cornellurology.com/BPH/history/. Accessed November 02, 2015.

Cornell University, Department of Urology. BPH treatment - surgical. [Cornell University Web site]. 2010. Available at: http://www.cornellurology.com/BPH/treatments/surgical.shtml. Accessed November 02, 2015.

De la Rosette JJ, Floratos DL, Severens JL, et al. Transurethral resection vs microwave thermotherapy of the prostate: a cost-consequences analysis. BJU Int. 2003;92(7):713-718.

De la Rosette JJ, Gravas S. Fitzpatrick JM. Minimally invasive treatments of male lower urinary tract symptoms. Urol Clin North Am.2008;35(3):505-518.

Djavan B, Eckersberger E, Handl MJ, et al. Durability and retreatment rates of minimal invasive treatments of benign prostatic hyperplasia: a cross-analysis of the literature. Can J Urol. 2010;17(4):5249-5254.

Dmochowski RM. Bladder outlet obstruction: etiology and evaluation. [National Center for Biotechnology Information (NCBI) Web site]. 2005. Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1477620/. Accessed November 03, 2015.

ECRI Institute. High-intensity focused ultrasound for benign prostatic hyperplasia and prostate cancer. Plymouth Meeting (PA): ECRI Institute; 2010 October 01. (ECRI hotline response). Also available at: http://www.ecri.org.Accessed November 03, 2015.

ECRI Institute. Photoselective vaporization of the prostate for benign prostatic hyperplasia. Plymouth Meeting (PA): ECRI Institute; 2010 September 20. (ECRI hotline response). Also available at: http://www.ecri.org. Accessed November 03, 2015.

ECRI Institute. Transurethral microwave therapy (TUMT) for benign prostatic hypertrophy. Plymouth Meeting (PA): ECRI Institute; 2004 October 10. (ECRI hotline response). Also available at: http://www.ecri.org. Accessed November 03, 2015.

ECRI Institute. Water-induced thermotherapy for benign prostatic hyperplasia. Plymouth Meeting (PA): ECRI Institute; 2011 April 22. (ECRI hotline response). Also available at: http://www.ecri.org. Accessed November 03, 2015.

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.

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.

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.

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.

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.

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 November 03, 2015.

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]. 03/29/11. Available at: http://www.emedicine.com/med/topic3069.htm. Accessed November 03, 2015.

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.

National Institutes of Health (NIH). Clinicaltrials.gov search results. [NIH web site]. Available at: https://clinicaltrials.gov/ct2/show/NCT02505919. Accessed February 10, 2016.
Neotract Inc. Urolift--BPH Relief In Sight. 2012. Available at: https://www.urolift.com/medical/urolift-system--urolift.html Accessed November 03, 2015

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.

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.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


THE FOLLOWING CODES ARE USED TO REPRESENT TRANSURETHRAL RESECTION OF THE PROSTATE (TURP)

52601, 52630

THE FOLLOWING CODE IS USED TO REPRESENT HOLMIUM LASER ABLATION OF THE PROSTATE (HoLRP), 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

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE (TUNA)

53852

THE FOLLOWING CODES ARE USED TO REPRESENT PROSTATIC URETHRAL LIFT (UROLIFT ®)

52441, 52442


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 CODE IS USED TO REPRESENT WATER-INDUCED THERMOTHERAPY (WIT)

55899

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL MICROWAVE THERMOTHERAPY (TUMT)

53850

EXPERIMENTAL/INVESTIGATIONAL

0421T

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL BALLOON DILATION

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)

53899



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C61 Malignant neoplasm of prostate

N40.1 Benign prostatic hyperplasia with lower urinary tract

N40.3 Nodular prostate with lower urinary tract symptoms

Z85.46 Personal history of malignant neoplasm of prostate



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:

THE FOLLOWING CODES REPRESENT PROSTATIC URETHRAL LIFT (UROLIFT ®)

C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants

C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants


EXPERIMENTAL/INVESTIGATIONAL

C9747 Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.17.06l
11/22/2017This policy has been reissued in accordance with the Company's annual review process.

Effective 10/05/2017 this policy has been updated to the new policy template
format.
Version Effective Date: 07/01/2017
Version Issued Date: 06/30/2017
Version Reissued Date: 11/29/2017

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.