Summary Of Evidence

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Analysis of Evidence

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Abstract:

Benign prostatic hyperplasia is an enlargement of the prostate gland that frequently occurs in men as they age. Current treatments include watchful waiting, medications i.e., alpha-blockers, and surgery. The gold standard for treating this condition is a transurethral resection of the prostate (TURP). Some patients may not be healthy enough to undergo this procedure and choose a less invasive procedure to treat this condition. This local coverage determination (LCD) addresses laser therapy of the prostate.

Laser prostatectomy, or visual laser ablation of the prostate (VLAP) is an alternative technique to the conventional surgical intervention of transurethral resection of the prostate (TURP) in treating bladder outlet obstruction caused by benign prostate hypertrophy (BPH).

Laser ablation of the prostate involves delivery of laser energy to the prostate in one of five main variations. These are: the transurethral ultrasound-guided laser-induced prostatectomy (TULIP), the free-fiber visually guided laser ablation of the prostate (VLAP), visually guided contact laser ablation of the prostate (CLAP), ultrasound guided interstitial laser coagulation of the prostate (ILCP), and the Holmium: YAG Laser (holmium laser ablation of the prostate -HoLAP, and holmium enucleation of the prostate - HoLEP).

Laser enucleation of the prostate using a high power laser source is performed on a small subset of patients requiring prostate surgery due to the enlarged size of the prostate. A laser fiber is used to undermine and dissect away large pieces of prostate tissue that migrate into the bladder and are subsequently extracted at the end of the procedure.

Indications:

Laser prostatectomy is indicated as a treatment modality for patients with bladder neck obstruction secondary to benign prostatic hyperplasia (BPH). Laser surgery provides some advantages over traditional TURP in that the hospital stay is decreased, patients can resume normal activities quicker and morbidity is reduced.

These procedures will be covered for the following indications:

1. Duration of BPH 3 months or longer;
2. American Urology Association (AUA) symptom score greater than 9 Urodynamics and Post-void Residual Volume examinations should be used as appropriate, e.g., patients with suspected neurologic disease or those who have failed prostate surgery.
   
   Limitations:
   
   A relative contraindication for these procedures is an active urinary infection.
   
   The use of these devices must be prescribed and administered under the personal supervision of a qualified and trained physician, after appropriate urological evaluation of the patient. The treating physician must be present at all times during the treatment.
   
   Other Comments:
   
   For claims submitted to the Part A MAC: This coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC to process their claims.
   
   Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.
   
   Limitation of liability and refund requirements apply when denials are based on medical necessity. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be considered medically necessary by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.
   
   For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.
   
   For outpatient settings other than CORFs, references to "physicians" throughout this policy include non-physicians, such as nurse practitioners, clinical nurse specialists and physician assistants. Such non-physician practitioners, with certain exceptions, may certify, order and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.)