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DESCRIPTIONTransurethral microwave thermotherapy (TUMT) has been proposed as an alternative to transurethral resection of the prostate (TURP), or daily medical therapy, for patients who have benign prostatic hyperplasia (BPH). Although TURP has been historically considered definitive treatment, complications from this treatment have encouraged the development of less invasive techniques.
Benign prostatic hyperplasia (BPH) is a condition which may lead to lower urinary tract symptoms such as urinary frequency, nocturia, urinary hesitancy and feeling of incomplete voiding. Histologic evidence of BPH is present in approximately 50% of men at age 50 and the prevalence increases with advancing age. Glandular overgrowth causes progressive occlusion of the prostatic portion of the urethra in men, and will cause lower urinary tract symptoms to varying degrees. Transurethral resection of the prostate (TURP) is one of the most commonly performed surgeries and is generally well tolerated, but is not without potential complications, such as blood loss (with or without the need for transfusion), retrograde ejaculation and incontinence. Transurethral resection syndrome is an adverse effect that can occur in up to 2% of cases. The syndrome is caused by absorption of bladder irrigation fluids during the TURP procedure. Depending on the severity, this syndrome can lead to hyponatremia and fluid overload with subsequent neurological and cardiac complications. Less invasive techniques have been investigated using various energy sources, such as laser, direct heat, microwave, radiofrequency and ultrasound. With these techniques, a calculated amount of prostate tissue is destroyed and reabsorbed while leaving the epithelium of the urethral canal relatively intact. This policy addresses the use of microwave energy in the reduction of urethral occlusion and lower urinary tract symptoms.
The goal of microwave thermotherapy is destruction of the prostatic adenoma in the lateral lobes of the prostate to achieve improvement in symptoms and voiding. A transurethral catheter containing a microwave antenna that limits microwave radiation is placed at the prostatic level. Water circulating through the catheter cools the urethra. A Foley-type balloon at the end of the catheter inflates to position the catheter, and fiberoptic sensors are positioned to monitor rectal and urethral temperatures. The correct position of the catheter is verified using transrectal ultrasound of the prostate. The electromagnetic waves emit high-energy photons that interact with molecules in prostatic tissue, producing heat.
Transurethral microwave thermotherapy (TUMT) produces coagulation necrosis of the lateral lobes of the prostate for a distance up to 17 mm from the urethra with the preservation of the urethral surface, distal sphincter, urethral mucosa, bladder neck, and peripheral prostate.
In October 2000, the FDA issued an alert regarding 16 unexpected cases of fistula formation or urethral or penile tissue damage following the use of transurethral microwave thermotherapy devices. In this alert, the FDA recommended ensuring the patient meets criteria for eligible prostate size and had not previously received radiation to the area. It further recommended that the physician remain with the patient throughout the procedure, to verify placement at all times, and to monitor any unusual pain reported. The patient is not to be oversedated.
In December 2002, the Prostalund® CoreTherm™ System (Prostalund Operations AB, Concord, MA) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process for use in men with BPH who have a prostate size of 30 to 100 grams and prostatic urethra length of 35 mm or greater. Although similar to previous microwave thermotherapy devices, the company sought PMA due to the addition of temperature feedback features intended to address earlier safety concerns related to thermal injuries. The treatment is contraindicated in men with a prostate less than 30 grams or a prostate length less than 35 mm.
In February 2004, the Prolieve® Thermodilation System (now owned by Medifocus; Columbia, MD) was approved by the FDA for the treatment of BPH through the PMA process in men with a prostate size of 20 to 80 grams and prostatic urethra length between 1.2 and 5.5 cm, and in whom drug therapy is typically indicated. The treatment is contraindicated in men with prostate sizes less than 20 grams and greater than 80 grams.
POLICYTransurethral Microwave Thermotherapy (TUMT) for benign prostatic hyperplasia may be considered medically necessary for patients who, based on severity of their BPH symptoms, would be candidates for transurethral resection of the prostate.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
For technical reasons, transurethral microwave thermotherapy is not suitable for patients who have median lobe enlargement, bladder neck stenosis, or in whom the prostate gland does not meet the size recommendations for the particular device used, including prostatic urethra length and gland volume.
Microwave thermotherapy should not be confused with an earlier technique of microwave treatment, microwave hyperthermia, which has largely been abandoned, and is not eligible for coverage.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
POLICY HISTORY6/1997: Approved by the Medical Policy Advisory Committee (MPAC)
5/8/2001: Code Reference section updated (ICD-9 Procedure code 60.29 & 60.99 deleted; 60.96 added; ICD-9 Diagnosis code 600 range expanded)
5/8/2002: Type of Service and Place of Service deleted
3/12/2004: Code Reference section updated, ICD-9 diagnosis code range 600.0-600.9 (600.00, 600.01, 600.10, 600.11, 600.20, 600.21, 600.3) deleted, ICD-9 diagnosis code 600.90 and 600.91 remain as covered
6/24/2004: Policy reviewed, Policy section "of 35-50 mm" changed to "less than 5 cm", Sources updated
9/19/2006: Coding revised. ICD9 2006 revisions added to policy
1/6/2009: Policy reviewed, no changes
09/09/2010: Policy description extensively re-written. Policy statement revised to change the prostatic lengths criteria from "less than 5 cm" to "35-50 mm."
09/23/2011: Moved the following verbiage from the Policy Statement section to the Policy Guidelines section: For technical reasons, transurethral microwave thermotherapy (TUMT) is not suitable for patients in whom the prostate gland exceeds 50 mm in length or 70 g in volume), who have median lobe enlargement, or bladder neck stenosis. Deleted outdated references from the Sources section.
09/27/2012: Policy reviewed; no changes.
11/01/2013: Policy description updated. “Prostatic lengths of 35-50 mm” was removed from the policy statement. Policy guidelines updated regarding suitable candidates. Added ICD-9 codes 600.01 and 600.21 to the Code Reference section. Deleted ICD-9 code 600.90 from the Code Reference section.
08/14/2015: Medical policy revised to add ICD-10 codes.
06/08/2016: Policy number added. Policy Guidelines updated to add medically necessary definition.
09/30/2016: Code Reference section updated to revise the code description for ICD-10 diagnosis code N40.1
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.52
CODE REFERENCEThis 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.