*** This policy was implemented in the absence of National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) coverage criteria. This policy applies to all Blue Medicare HMO, Blue Medicare PPO, Healthy Blue + MedicareSM (HMO-POS D-SNP), Blue Medicare Rx members, and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services. ***

Description of Procedure

High-Intensity Focused Ultrasound (HIFU) is a minimally invasive medical procedure that uses focused ultrasound waves to treat certain conditions, such as tumors, uterine fibroids and tremors. The very high intensity and highly focused sound waves interact with targeted tissues in the body to modify or destroy them. HIFU focuses high-energy ultrasound waves on a single location, which increases the local tissue temperature to over 80°C. This causes a discrete locus of coagulative necrosis of approximately 3×3×10 mm. The surgeon uses a transrectal probe to plan, perform, and monitor treatment in a real-time sequence to ablate the entire gland or small discrete lesions.

This policy will focus on the use of HIFU for cancer of the prostate. 

Although HIFU has been cleared by the U.S. Food and Drug Administration (FDA) for prostate tissue ablation, its role in the management of prostate cancer continues to evolve. Evidence is more robust for salvage therapy following radiation failure, while data for primary treatment remains less mature compared to established standards (radical prostatectomy, radiation therapy).

Policy Statement

Coverage will be provided for HIFU when it is determined to be medically necessary when the medical criteria and guidelines shown below are met.

Benefit Application

Please refer to the member’s individual Evidence of Coverage (EOC) for benefit determination.  Coverage will be approved according to the EOC limitations if the criteria are met.

Coverage decisions will be made in accordance with:

• The Centers for Medicare & Medicaid Services (CMS) national coverage decisions;
• General coverage guidelines included in original Medicare manuals unless superseded by operational policy letters or regulations; and
• Written coverage decisions of local Medicare carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered.

Benefit payments are subject to contractual obligations of the Plan.  If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the member’s particular Evidence of Coverage (E.O.C.), the E.O.C. always governs the determination of benefits.

Indications for Coverage

High-Intensity focused ultrasound (HIFU) may be considered medically necessary for the treatment of recurrent prostate cancer following prior radiation therapy OR, primary (previously untreated) prostate cancer in individuals with a history of prior pelvic radiation performed for another condition.

Let’s

1. Preauthorization by the Plan is required;
2. The member has recurrent prostate cancer; AND
3. Current PSA is <10ng/mL, AND
4. The original disease (pre-radiation therapy) was stage T1-T2, NX or N0, OR is in the setting or prior pelvic radiation AND
5. For treatment of biopsy-confirmed recurrent prostate cancer previously; AND
6. The risks and benefits of the different modalities for therapy of localized, radio-recurrent prostate cancer or treatment options for initial prostate cancer in the setting of prior pelvic radiation have been discussed, and it has been determined that HIFU is the best treatment choice for the patient.
7. Absence of metastatic disease.

Clinical information/documentation should include:

1. Pathology report confirming prostate cancer
2. Prior treatment history (including radiation, if applicable)
3. Imaging studies (e.g., MRI/CT, bone scan if relevant)
4. PSA history and staging information
5. Clinical rationale for HIFU vs standard therapies

When Coverage Will Not Be Approved

1. HIFU for the initial treatment of clinically localized prostate cancer. 
2. For treatment in members with metastatic prostate cancer.
3. Extensive locally advanced disease not amendable to focal therapy
4. Repeat HIFU treatments without documentation of clinical benefit.
5. When used for treatment of benign prostatic conditions (e.g., BPH).

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes.  Inclusion of a code in the section does not guarantee reimbursement.

Applicable codes: 55880

The Plan may request medical records for determination of medical necessity.  When medical records are requested, letters of support and/or explanation are often useful but are not sufficient for documentation unless all specific information needed to make a medical necessity determination is included.

References

1. American Urological Association (AUA). Salvage therapy for prostate cancer: AUA/ASTRO/SUO guideline 2024. https://auanet.org. 
2. Muto S, Yoshii T, Saito K, et al. Focal therapy with high-intensity-focused ultrasound in the treatment of localized prostate cancer. Jpn J Clin Oncol. Mar 2008; 38(3): 192-9. PMID 18281309
3. National Comprehensive Cancer Network. Prostate Cancer. Version 2.2026 https://www.nccn.org
4. Hayes, Inc. Health Technology Assessment. High-intensity focused ultrasound for salvage therapy of recurrent prostate cancer. https://evidence.hayesinc.com. Published March 30, 2017. Updated May 6, 2021.
5. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Prostate cancer. https://nccn.org. Updated December 4, 2025.Article
6. Hayes, Inc. Health Technology Assessment. Ultrasound-guided high-intensity focused ultrasound for primary treatment of localized prostate cancer. https://evidence.hayesinc.com. Published November 20, 2025.
7. National Institute for Health and Care Excellence (NICE). Focal Therapy Using High-Intensity Focused Ultrasound for Localized Prostate Cancer [IPG756]. 2023; https://www.nice.org.uk/guidance/ipg756
8. Van den Bos W, Muller BG, Ahmed H, et al. Focal therapy in prostate cancer: international multidisciplinary consensus on trial design. Eur Urol. Jun 2014; 65(6): 1078-83. PMID 24444476

Policy Implementation/Update Information:

May 19, 2026 – Newly created policy. Due to the absence of NCD, LCD for Palmetto. (JM)

Approval Dates:

Physician Advisory Group Committee: August 18, 2026