Prostatic Urethral Lift

POLICY NUMBER

A.7.01.151

DESCRIPTION

Benign prostatic hyperplasia is a common condition in older individuals that can lead to increased urinary frequency, an urgency to urinate, a hesitancy to urinate, nocturia, and a weak stream when urinating. The prostatic urethral lift procedure involves the insertion of one or more permanent implants into the prostate, which retracts prostatic tissue and maintains an expanded urethral lumen.

Use of temporarily implanted nitinol devices for benign prostatic hyperplasia is addressed separately in the Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia.

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a common disorder among older individuals that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. The clinical manifestations of BPH include increased urinary frequency, nocturia, an urgency or hesitancy to urinate, and a weak stream when urinating. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection. Benign prostatic hyperplasia prevalence increases with age and is present in more than 80% of individuals ages 70 to 79 years.

Two scores are widely used to evaluate BPH-related symptoms: the American Urological Association Symptom Index (AUASI) and the International Prostate Symptom Score (IPSS). The AUASI is a self-administered 7-item questionnaire assessing the severity of various urinary symptoms. Total AUASI scores range from 0 to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35). The International Prostate Symptom Score incorporates questions from the AUASI and a quality of life question or a “Bother score.”

Evaluation and management of BPH include assessment for other causes of lower urinary tract dysfunction (eg, prostate cancer), symptom severity, and the degree that symptoms are bothersome to determine the therapeutic approach.

For patients with moderate-to-severe symptoms (eg, an AUASI score of ≥8), bothersome symptoms, or both, a discussion about medical therapy is reasonable. Benign prostatic hyperplasia should generally be treated medically first. Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (eg, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (eg, finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (eg, darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (eg, tadalafil). In a meta-analysis of both indirect comparisons from placebo-controlled studies (including 6,333 patients) and direct comparative studies (including 507 patients), Djavan and colleagues found that the IPSS improved by 30% to 40% and the Qmax score (mean peak urinary flow rate) improved by 16% to 25% in individuals assigned to α-adrenergic blockers. Combination therapy using an α-adrenergic blocker and 5α-reductase inhibitor has been shown to be more effective for improving IPSS than either treatment alone, with median scores improving by more than 40% over 1 year and by more than 45% over 4 years.

Patients who do not have sufficient response to medical therapy, or who are experiencing significant side effects with medical therapy, may be referred for surgical or ablative therapies. Various surgical and ablative procedures are used to treat BPH. Transurethral resection of the prostate is generally considered the reference standard for comparisons of BPH procedures. In the perioperative period, transurethral resection of the prostate is associated with risks of any operative procedure (eg, anesthesia risks, blood loss). Although short-term mortality risks are generally low, a large prospective study with 10,654 patients reported the following short-term complications: “failure to void (5.8%), surgical revision (5.6%), significant urinary tract infection (3.6%), bleeding requiring transfusions (2.9%), and transurethral resection syndrome (1.4%).” Incidental carcinoma of the prostate was diagnosed by histologic examination in 9.8% of patients. In the longer term, transurethral resection of the prostate is associated with increased risk of sexual dysfunction and incontinence.

Several minimally invasive prostate ablation procedures are available, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate. The minimally invasive procedures were individually compared with transurethral resection of the prostate at the time they were developed, which provided a general benchmark for evaluating those procedures. The American Urological Association (AUA) recommends surgical intervention for patients who have "renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with lower urinary tract symptoms (LUTS) attributed to BPH refractory to and/or unwilling to use other therapies."

One implantable transprostatic tissue retractor system has been cleared for marketing by the FDA through the 510(k) process. In 2013, the NeoTract UroLift® System UL400 (NeoTract) was cleared (after receiving clearance through the FDA’s de novo classification process in March 2013; K130651/DEN130023). In 2016, the FDA determined that the UL500 was substantially equivalent to existing devices (UL400) for the treatment of symptoms of urinary flow obstruction secondary to benign prostatic hyperplasia in individuals ages 50 years and older. In 2017, the FDA expanded the indication for the UL400 and UL500 to include "lateral and median" lobe hyperplasia in men 45 years or older. An additional clearance in 2019 (K193269) modified an existing contraindication for use from men with prostate volume of >80 cc to men with a prostate volume of >100 cc. FDA product code: PEW.

POLICY

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

• The individual has persistent or progressive lower urinary tract symptoms despite medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months, or is unable to tolerate medical therapy; AND,

• Prostate gland volume is ≤80 mL; AND,

• Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND,

• Individual does not have acute urinary retention related to conditions other than benign prostatic hyperplasia, urinary tract infection, or recent prostatitis (within past year); AND,

• Individual has had appropriate testing to exclude diagnosis of prostate cancer; AND,

• Individual does not have a known allergy to nickel, titanium, or stainless steel.

Use of prostatic urethral lift in other situations, including repeat procedures, is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Use of temporarily implanted nitinol devices for benign prostatic hyperplasia is addressed separately in the Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia medical policy.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

11/19/2015: Approved by Medical Policy Advisory Committee.

06/01/2016: Policy number A.7.01.151 added.

09/23/2016: Policy description updated regarding devices. Policy statement unchanged.

06/26/2017: Code Reference section updated to add new HCPCS code C9746, effective 07/01/2017.

02/22/2018: Policy description updated regarding medical therapy and outcome measures to evaluate BPH symptoms. Added statement that the use of prostatic urethral lift in individuals with moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia may be considered medically necessary when certain criteria are met. Investigational statement revised to state that the use of prostatic urethral lift in other situations is considered investigational. Investigational Codes table changed to Medically Necessary Codes table. Added ICD-10 diagnosis code N40.1.

10/02/2018: Policy description updated regarding devices. Medically necessary statement regarding the patient not being a surgical candidate for transurethral resection of the prostate was removed.

06/20/2019: Code Reference section updated to add new CPT codes 0548T, 0549T, 0550T, and 0551T, effective 07/01/2019.

09/23/2020: Code Reference section updated to add new HCPCS code C9769, effective 10/01/2020. Removed deleted HCPCS code C9746.

01/28/2021: Medically necessary policy statement updated regarding the following: 1) Changed "urinary retention" to "acute urinary retention;" 2) Removed criteria that the patient does not have prostate specific antigen level ≥3 ng/mL; and 3) Updated criteria to include allergies to titanium or stainless steel. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to add ICD-10 diagnosis code N40.3.

12/09/2021: Policy description updated regarding the American Urological Association recommendation. Policy statements unchanged. Code Reference section updated to add new CPT codes 53451, 53452, 53453, and 53454, effective 01/01/2022.

10/11/2022: Policy description updated regarding benign prostatic hyperplasia prevalence. Policy statements updated to change "patient" to "individuals."

07/01/2023: Code Reference section updated to remove HCPCS code C9769 and deleted codes 0548T, 0549T, 0550T, and 0551T.

10/04/2023: Policy reviewed. Medically necessary criteria revised to state: "Individual does not have acute urinary retention related to conditions other than benign prostatic hyperplasia, urinary tract infection, or recent prostatitis (within past year)." It previously stated: "Individual does not have acute urinary retention, urinary tract infection, or recent prostatitis (within past year)." Policy Guidelines updated to add related medical policy.

08/06/2024: Code Reference section updated to remove CPT codes 53451, 53452, 53453, and 53454. These codes were added to the Prosthetics medical policy.

10/17/2024: Policy reviewed; no changes.

09/18/2025: Policy description updated regarding the use of temporarily implanted nitinol devices for benign prostatic hyperplasia. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.151

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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