A. Primary Whole-Gland Cryoablation
Covered when ALL of the following are met:
ALL of the following
Histologically confirmed prostate adenocarcinoma with documented PSA, grade group, clinical stage, and number and extent of positive cores [S1, S3]
Clinically localized disease (clinical T1 to T3) with no nodal or distant metastasis on staging appropriate to the risk group [S2, S1]
Low- or intermediate-risk disease; high-risk disease is reviewed only within a clinical trial or by physician review [S1]
The member is not a suitable candidate for radical prostatectomy or radiotherapy because of comorbidity, prior pelvic radiation, or another documented reason, or has declined them after counseling [S1]
Estimated life expectancy greater than 10 years [S1]> 10 years
For low-risk disease, documented counseling that active surveillance is the preferred management and that cryoablation has considerable side effects without a shown survival benefit over surveillance [S1]
Documented counseling on expected erectile dysfunction and on urinary incontinence and irritative or obstructive urinary effects [S1]
Treatment with a third-generation or later argon-based cryosurgical system [S1]
B. Primary HIFU (Whole-Gland or Partial-Gland)
Primary transrectal HIFU may be approved on individual physician review when ALL of the following are met:
ALL of the following
Histologically confirmed adenocarcinoma, clinically localized, with low-risk or favorable intermediate-risk disease and no evidence of metastasis [S1, S3]
Multiparametric prostate MRI and biopsy (systematic plus targeted) performed within the preceding 12 months, with the treatment field encompassing all known clinically significant disease [S1, S3]Within preceding 12 months
Estimated life expectancy of at least 10 years [S1]>= 10 years
Active surveillance, radical prostatectomy, and radiotherapy were discussed, and the record states why they are not preferred or are contraindicated [S1]
C. Salvage Cryoablation or HIFU After Radiotherapy
Salvage cryoablation or salvage HIFU for local recurrence after primary radiotherapy is medically necessary when ALL of the following are met:
ALL of the following
Primary treatment was radiotherapy (external beam or brachytherapy) [S2, S4]
Biochemical recurrence (PSA rise of 2 ng/mL or more above nadir) or other evidence of recurrence, with local recurrence confirmed on prostate biopsy [S4]PSA rise >= 2 ng/mL above nadir or other evidence of recurrence
No evidence of nodal or distant metastasis on staging, which may include PSMA PET in place of or after negative conventional imaging [S4]
For salvage cryoablation, at least one of the following favorable features is documented: clinical stage T2b or below, Gleason score below 9, or PSA below 8 ng/mL [S2]
At least one favorable feature is required for salvage cryoablation.
D. Procedure and Facility Requirements
For any approved ablation, ALL of the following apply:
ALL of the following
The device is FDA-cleared or approved and used within its cleared use [S1]
The treating urologist has documented experience with the technique, and imaging guidance, anesthesia, and follow-up are planned [S1, S3]
Prior transurethral resection with a significant prostatic defect has been assessed; it is a relative contraindication to whole-gland cryoablation and requires physician review [S1]
Continuation, Repeat Service, and Re-authorization
A repeat ablation session is reviewed by a physician and may be approved when ALL of the following are met:
ALL of the following
Biopsy-confirmed persistent or recurrent cancer within the previously treated field after whole-gland or hemi-gland HIFU or cryoablation [S1, S4]
Restaging shows no metastatic disease [S4]
Prostatectomy and radiotherapy were considered and the reason they are not preferred is documented [S4]
Does Not Meet Criteria
The following do not meet medical-necessity criteria under this policy. A request in these circumstances is referred for physician review; it is not denied by an automated system or a non-physician reviewer.
ALL of the following
Focal laser ablation (including MRI-guided and dual-fiber laser), photothermal ablation with nanoparticles, irreversible electroporation, magnetic-field induction ablation, water-vapor thermal therapy for cancer, vascular-targeted photodynamic therapy, and MRI-guided transurethral ultrasound ablation.
Experimental/investigational: durable comparative oncologic outcomes are not established; refer for physician review under the plan's experimental and investigational criteria. [S1, S3]
ALL of the following
Ablation of high-risk localized prostate cancer outside a clinical trial.
Not recommended by the AUA/ASTRO guideline outside a trial. [S1]
Nodal or distant metastasis on staging, including PSMA PET, excludes local ablation under this policy. Local ablation does not meet criteria; refer for multidisciplinary systemic or radiation planning and physician review. [S4]
Focal laser ablation, photothermal ablation with nanoparticles, irreversible electroporation, magnetic-field induction ablation, water-vapor thermal therapy for cancer, vascular-targeted photodynamic therapy, and other investigational focal or ablation techniques are experimental/investigational because durable comparative oncologic outcomes are not established. Refer for physician review under the plan's experimental and investigational criteria. [S1, S3]
Coverage is limited to adults. Covered places of service are 19, 22, or 24, or inpatient when medically required. [S1]
Ablation of high-risk or very-high-risk localized prostate cancer is not recommended outside a clinical trial. Route to physician review and clinical-trial coverage under the plan's clinical trial standards when applicable. [S1]
Ablation in a member with low- or intermediate-risk disease and life expectancy of 5 years or less is not medically necessary; observation or watchful waiting is recommended. [S1]
Focal treatment requires MRI and systematic plus targeted biopsy localization, and the treatment field must encompass all known clinically significant disease. Focal treatment is not medically necessary when disease extends beyond the planned treatment field because of the risk of untreated cancer; focal therapy may not be curative. [S1, S3]
Salvage ablation after primary radiotherapy is not medically necessary without biopsy-confirmed local recurrence or when metastatic disease is present. Biopsy confirmation and staging must precede salvage ablation. [S4]
Ablation requested for convenience is not medically necessary when active surveillance or another established option is clinically appropriate and preferred by the treating clinician. [S1]