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Medical Policy | ||
| Subject: Surgery for Benign Prostatic Hypertrophy (BPH) | |||
| Policy #: SURG.00028 | Current Effective Date: | 05/07/2007 | |
| Status: Revised | Last Review Date: | 03/08/2007 | |
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Description/Scope
Multiple procedures have been developed to treat benign prostatic hypertrophy (BPH). This policy addresses various surgical procedures used in the treatment of BPH.
Policy Statement
Medically Necessary:
The following surgical procedures are considered medically necessary as an alternative to open prostatectomy or transurethral resection of the prostate (TURP) for the treatment of benign prostatic hypertrophy (BPH) and include:
Water induced thermotherapy (WIT), also known as thermourethral hot-water therapy, is considered medically necessary as a non-surgical treatment for BPH.
Not Medically Necessary:
Endoscopic balloon dilation of the prostatic urethra is considered not medically necessary as a treatment for BPH in all applications.
Investigational/Not Medically Necessary:
High-intensity focused ultrasound (HIFU) ablation used in the treatment of prostatic hypertrophy is considered investigational/not medically necessary in all applications.
Cryosurgical ablation of the prostate is considered investigational/not medically necessary for the treatment of BPH in all applications.
Placement of temporary prostatic stents is considered investigational/not medically necessary for all uses, including, but not limited to BPH, following surgical treatment of BPH, prostate cancer, or radiation therapy.
The following prostatectomy procedures are considered investigational/not medically necessary for all applications other than BPH:
Rationale
Standard surgical treatments for BPH are some of the most common therapies in medical practice but may be accompanied by undesirable complications such as blood loss, need for transfusion and absorption of irrigation fluids and may result in side effects such as retrograde ejaculation and incontinence. There have been attempts to develop new surgical techniques that use lasers, as well as minimally invasive techniques using various sources of energy including heat, microwaves, radiofrequency, and ultrasound. There are a number of outcome variables to examine in comparing these less invasive treatments to transurethral resection of the prostate (TURP), considered the “gold standard” for treatment of BPH (AHRQ, 2004).
Laser prostatectomy procedures, transurethral incision of the prostate (TUIP), transurethral microwave thermotherapy (TUMT), transurethral radiofrequency needle ablation (RFNA/TUNA), and transurethral vapor resection of the prostate (TUVRP) have been established as useful and alternative procedures for transurethral resection of the prostate (TURP). Evidence published in the peer-reviewed medical literature suggests that these procedures can provide improvement in benign prostatic hypertrophy (BPH) symptoms, voiding function, and urinary retention. Although there is no data directly comparing WIT with either TURP or other surgical procedures, WIT has been shown to relieve the symptoms of BPH without the occurrence of blood loss, incontinence, and impotence as sometimes associated with TURP.
The evidence published in the peer-reviewed medical literature also suggests that transurethral microwave thermotherapy (TUMT) is an effective alternative treatment for TURP. Several randomized controlled trials have demonstrated that TUMT has similar efficacy as TURP in symptom relief and patient satisfaction. However, the FDA identified unexpected procedure-related complications with TUMT in a public health notification dated October 11, 2000. The letter notified the medical community of the potential for serious thermal injury and related complications associated with the use of microwave energy to treat BPH. The nature of the problem, complications, and recommendations to help avoid these complications were outlined in this safety alert.
The efficacy of these procedures discussed above, as treatment in individuals with prostatic conditions other than BPH has not yet been established. The level of evidence supporting the use of the technologies mentioned for conditions other than BPH is insufficient to draw conclusions regarding safety and efficacy. Further studies are needed before they can be considered a standard method of treatment for any condition other than BPH.
The American Urological Association (AUA) published Guideline on the Management of Benign Prostatic Hyperplasia (BPH) states there is insufficient and inadequate evidence available to support a number of procedures for the treatment of BPH (AUA, 2005). The level of evidence regarding the safety and utility of endoscopic balloon dilation, high-intensity focused ultrasound (HIFU) ablation, cryosurgical ablation, and the placement of temporary prosthetic 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.
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 (AUA, 2005). The 4th International Consultation on BPH has rated balloon dilation as an unacceptable treatment option since 1995 (Denis, 1998).
High-intensity focused ultrasound (HIFU) ablation is a minimally invasive procedure using a transrectal ultrasound probe to image the prostate and deliver timed bursts of heat to create coagulation necrosis in a targeted area without harming adjacent healthy tissue. A clinical trial by Schatzl and colleagues (2000) compared the efficacy of TURP to four less invasive treatment options including HIFU. Randomization was attempted but could not be carried out because patient characteristics such as prostate size, prostatic calcifications and middle lobes limited the types of patients who could receive the different treatments. The patients who received HIFU tended to have smaller prostates and less severe symptoms than those who received TURP (AHRQ, 2004). A second study reported by Madersbacher and colleagues (2000) attempted to determine the long-term outcome after HIFU therapy for patients with lower urinary tract symptoms (LUTS) due to BPH. The data collected between June 1992 and March 1995 indicated that HIFU therapy for BPH, at least in its present form, did not stand the test of time, as 43.8% of patients had to undergo TURP within four years after initial therapy. Additional long-term studies are warranted to reliably assess the role of HIFU as an established alternative to standard treatments for BPH.
The use of temporary prostatic stents has been proposed for the treatment of urinary obstruction due to BPH, following surgical treatment of BPH and prostate cancer, or following radiation therapy. Intraprostatic stenting has been investigated as a short-term treatment option permitting voluntary urination as an alternative to a Foley catheter with an external collection system. A temporary prostatic stent, The Spanner™ (Abbeymoor Medical, Inc., Parkers Prairie, MN), recently received premarket approval (PMA) from the FDA based on a multi-center, prospective, controlled, randomized clinical investigation designed to evaluate the safety and effectiveness of The Spanner™ to manage lower urinary symptoms and bladder emptying after 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.”
In The Spanner™ clinical investigation, a total of 186 male subjects, 45 years of age and older, were randomized into two groups at a visit 3-10 days following TUMT for BPH, Foley catheter removal, and demonstration of a successful voiding trial (defined as a post-void residual (PVR) <250 ml with mean voided volume of at least 100 ml). A total of 100 subjects who received The SpannerTM and 86 subjects in the control group were studied for changes in International Prostate Symptom (IPPS), post-void residuals, and adverse events. Both groups were evaluated at 1, 2, and 4 week intervals during The SpannerTM indwelling period and at 1 and 4 weeks after The SpannerTM removal.
A change in the IPPS was utilized to measure effectiveness from the baseline (pre-procedure) to the average IPSS score at visits 1 and 2 weeks after insertion. The IPSS is based on seven questions with total scores ranging from 0-35 points: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. Beginning with preoperative IPPS scores of approximately 22 points, The Spanner™ group score decreased by 7.28 points compared to 4.42 points in the control group, a difference of 2.86 points (p=0.019). However, although evaluation at the 1 week interval revealed a significant difference of 3 points between the groups (p=0.047), at 2 weeks and at subsequent visits, this was no longer the case (e.g. p=0.084 at 2 weeks).
Mean post void residual urine (PVR) was significantly less in The Spanner™ group compared to controls up to 4 weeks following randomization, with the mean decrease from pre-insertion baseline being 6.5 mls in The Spanner™ group versus a 28.5 ml increase in the control group. However, after 4 weeks there was no significant difference in PVR between the groups.
The FDA summary reported the majority of adverse events, greater than 75% for both groups, occurred during weeks 1 to 4 following insertion. Adverse events also occurred following removal of the device and included bleeding/hematuria, urinary frequency/retention/urgency, perineal pain, and symptomatic urinary tract infection. There were 385 adverse events reported by 99 subjects in The Spanner™ group and 273 adverse events reported by the 80 control group subjects. Of the urological adverse events requiring treatment, bacturemia occurred in 16.0% of The Spanner™ group compared to 10.5% in the control group. Micturition-burning was noted in 9.0% and 5.8%; perineal pain in 5.0% and 2.3%, respectively. However, the overall incidence of perineal pain was 26% in The Spanner™ group compared to 12.8% in the control group. Urinary retention (undefined) occurred in 10% and 15.1%, respectively. In The Spanner™ group, 2 of these occurred after removal of the temporary stent and 3% were associated with migration.
In summary, the study results are limited in demonstrating meaningful improvement in clinical outcomes in the group that received the temporary prostatic stent compared to the subjects studied who had a successful voiding trial after BPH surgery. The clinical significance of decreased IPSS scores at 1 week only with a difference of 3 points at that visit is questionable as is the difference in post-void residual noted up to 4 weeks, in the absence of increased urinary tract infections or other PVR related adverse effects in the control group compared to The Spanner™ group. On the other hand, perineal pain was noted to occur more frequently in The Spanner™ treated group.
There is a lack of scientific evidence published in the peer-reviewed literature that permits reasonable conclusions that cryosurgery ablation procedures would improve health outcomes in the treatment of BPH. The efficacy of other procedures including contact laser vaporization, interstitial laser coagulation, photosensitive laser vaporization, visually guided laser ablation, and holium laser resection of the prostate, transurethral ultrasound guided laser induced prostatectomy, transurethral radiofrequency needle ablation, transurethral microwave thermotherapy, and water induced thermotherapy in individuals with prostatic conditions other than BPH has not been established. Further studies are needed before they can be considered safe and effective methods of treatment for conditions other than BPH.
Background/Overview
Description of Disease
Benign prostatic hypertrophy (BPH) is a disorder caused by the over-growth of the prostate gland, which then interferes with the function of the bladder and urethra. This condition usually results in the increased frequency of urination, frequent nighttime urination (nocturia), urinary hesitancy and urgency, and weak urinary stream. These symptoms appear slowly and progress gradually over years. BPH is relatively rare in younger men, affecting about 8% of men age 31 to 40 years. The incidence of BPH increases with age occurring in approximately 40-50% of men aged 51 to 60 years and over 80% of men older than age 80 years. Unless a man with BPH demonstrates symptoms that interfere with his quality of life and cannot be controlled with medical therapy, surgical intervention is rarely indicated.
Description of Technology
Treatments for BPH may be surgical and non-surgical. Water-induced thermotherapy (WIT) involves a balloon catheter filled with circulating hot water to apply heat to the prostate, which destroys prostate tissue allowing the obstructed urethra canal to reopen. Prostatic stenting involves placement of a metal mesh tube into the urethra where it passes through the prostate. Once set in the proper location, the stent is expanded to press the urethral wall outward to prevent blockage by the prostate.
As previously indicated, there are several surgical approaches available to treat BPH. The oldest form of surgical treatment includes open prostatectomy, either approaching the surgical site through the abdomen or through the perineum. However, this approach has been associated with significant morbidity and long hospital stays and is currently reserved for treating prostates greater than 100 grams. Transurethral resection of the prostate (TURP) has been the preferred treatment modality for men with BPH for many years and it remains the standard against which other treatments are compared. During this procedure, surgical equipment is inserted into the urethra and guided to the area where the prostate constricts the urethral canal. Using a cutting tool, prostate tissue is excised leaving a cleared canal and a less massive prostate. The high rate of serious complications associated with TURP, along with the high prevalence of BPH, has encouraged development of alternative surgical treatments. Newer transurethral surgical treatments are designed as an alternative to long-term medical therapy, but with the potential benefits of shorter hospital length of stay, and decreasing recovery time when compared to TURP. The newer surgical approaches include laser therapy, transurethral electrovaporization, microwave therapy, and transurethral needle ablation. In these procedures, prostate tissue is removed through a heating method that destroys the desired amount of tissue that is reabsorbed by the body or expelled during urination. Following these procedures, as with TURP, a temporary catheter (tube) is left in the urethra to keep the urinary canal open while the surgical site heals. The catheter is then removed during a follow-up visit a few days after the surgery.
Although the use of microwave thermotherapy for the treatment of BPH with symptoms of urinary obstruction has been demonstrated to be safe and effective, and more than 25,000 procedures have been performed, the FDA has identified some unexpected procedure-related complications that have occurred since the initial marketing of these devices. The FDA has provided a notice and clinical guidance regarding this issue available on the FDA’s Center for Devices and Radiological Health (CDRH) website.
Proposed Benefits
The proposed benefits of any treatment of BPH is to improve voiding and prevent urinary retention, decrease the frequency of nighttime urination, and debulking of the enlarged gland to decrease discomfort and other symptoms. Additionally, transurethral approach may result in less blood loss and allow the procedure to be done on an outpatient basis.
Possible Risks
There are many potential risks involved with these procedures, including the customary risks associated with anesthesia. For transurethral approaches, risks also include excessive bleeding, bladder neck contracture, infection, scarring, incontinence, and ejaculatory problems. The risks associated with prostatic stent placement include infection, urethra stone formation, scarring and difficulty in removing the stent if needed.
Definitions
Ablation: removal or excision
Balloon dilatation of the prostate: a procedure proposed to relieve urinary retention due to BPH; during this procedure a flexible balloon catheter is placed in the urethra and moved up to the prostate; the balloon is then inflated for a short period of time to expand the urethra in this area
Benign prostate hyperplasia (BPH): a condition that causes an increase in the size of the prostate gland in men, commonly causing urinary retention
Cryosurgical: treatment performed with an instrument that freezes and destroys abnormal tissue
Electrovaporization of the prostate: a procedure that uses electrical energy to vaporize prostate tissues
High-intensity focused ultrasound (HIFU) ablation of the prostate: a procedure that uses timed bursts of ultrasound to create coagulation necrosis in a targeted area of the prostate
Hyperplasia: enlargement of an organ or tissue because of an increase in the number of cells in that organ or tissue
Hypertrophy: the enlargement or overgrowth of an organ or tissue due to an increase in size of its cells, rather than the number
Stent: a tube made of metal or plastic that is inserted into a vessel or passage to keep the lumen open and prevent closure due to a stricture or external compression
Transurethral: a surgical approach to prostate surgery that involves the insertion of surgical tools through the urethra instead of through an incision in the skin
Transurethral microwave thermotherapy (TUMT): a treatment that uses microwave energy to heat and shrink the prostate to provide relief of urinary obstruction due to BPH
Transurethral needle ablation (TUNA): see transurethral radiofrequency needle ablation (RFNA)
Transurethral radiofrequency needle ablation (RFNA): a non-surgical procedure in which low-level radiofrequency energy is delivered through a needle to a small area of the prostate, with the goal of relieving symptoms associated with BPH; it is also known as transurethral needle ablation (TUNA)
Water-induced thermotherapy (WIT): a non-surgical approach to the treatment of benign prostatic hypertrophy that involves the use of very hot water to shrink prostate tissue
Coding
The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Medically Necessary: CPT
ICD-9 Diagnosis
When services are also Medically Necessary:
CPT
ICD-9 Procedure
ICD-9 Diagnosis
When services are Investigational/Not Medically Necessary: For the procedure codes listed above, for all other diagnoses or when the code describes a procedure in the Policy section as investigational/not medically necessary
When services are Not Medically Necessary:
CPT
ICD-9 Procedure
ICD-9 Diagnosis
When services are Investigational/Not Medically Necessary:
ICD-9 Diagnosis
Services are also Investigational/Not Medically Necessary:
CPT
ICD-9 Diagnosis
References
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Index
Balloon Dilatation of Prostate
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
Policy History
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Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. ©CPT Only - American Medical Association |