ModifiedExcellus Health Plan IncPolicy 7.01.01

Focal Therapies for Prostate Cancer Treatment

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This policy addresses medical necessity for cryosurgery, HIFU, and other focal therapies for prostate cancer. Cryosurgery and HIFU may be appropriate for selected recurrent disease after radiation therapy when metastatic disease is absent; routine primary focal therapy and specified other modalities are investigational.

Policy Summary

PayerExcellus Health Plan Inc

PolicyFocal Therapies for Prostate Cancer Treatment

Policy CodePolicy 7.01.01

Change TypeModified

Effective DateAugust 20, 2026

Next Review DateAugust 1, 2027

Key ActionDocument recurrence after radiation therapy with a positive repeat biopsy and confirm absence of metastatic disease for cryosurgery or HIFU.

SourceLink

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ModifiedExcellus Health Plan IncPolicy 7.01.01

Focal Therapies for Prostate Cancer Treatment

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Policy Summary

PayerExcellus Health Plan Inc

PolicyFocal Therapies for Prostate Cancer Treatment

Policy CodePolicy 7.01.01

Change TypeModified

Effective DateAugust 20, 2026

Next Review DateAugust 1, 2027

Key ActionDocument recurrence after radiation therapy with a positive repeat biopsy and confirm absence of metastatic disease for cryosurgery or HIFU.

SourceLink

POLICY UPDATE CHANGES

CPT code 55877 was added in a 12/31/25 code edit.

The 08/20/26 annual review states that policy intent was unchanged.

2Required criteria for recurrent disease

InvestigationalRoutine primary focal therapy

7Additional investigational modalities

1CPT code added

Medical Necessity and Investigational Services

Recurrent prostate cancer after radiation therapy

Cryosurgery and high-intensity focused ultrasound (HIFU) for recurrent prostate cancer are medically appropriate when ALL of the following are met:

Recurrence after radiation therapy: Prostate cancer has recurred after radiation therapy, as evidenced by a positive repeat biopsy.Positive repeat biopsy

No metastatic disease: Metastatic disease is absent.Absence of metastatic disease

Routine primary focal therapy for localized prostate cancer

Routine primary therapy for localized prostate cancer is considered investigational.

Routine primary focal therapy: Cryotherapy or other focal therapies, including HIFU, performed as routine primary therapy for localized prostate cancer are considered investigational.Localized prostate cancer treated as routine primary therapy

Other routine focal therapies

The following focal therapies for routine treatment of prostate cancer are considered investigational. This list includes, but is not limited to, the following modalities:

Investigational focal therapy modalities: Vascular-targeted photodynamic therapy (VTP), irreversible electroporation (IRE), NanoKnife for tissue ablation, laser interstitial thermal therapy (LITT), transurethral ultrasound ablation (TULSA), magnetic field induction (NanoTherm therapy), and high-energy water vapor thermotherapy are considered investigational when used for routine treatment of prostate cancer.Routine treatment of prostate cancer

The listed modalities are examples and are not an exhaustive list.

Professional guideline recommendations

The following professional guideline recommendations are summarized separately from payer-specific coverage criteria:

Low- or intermediate-risk disease counseling: Clinicians should inform patients with low- or intermediate-risk prostate cancer who are considering whole-gland or focal ablation that high-quality data comparing ablation outcomes with radiation therapy, surgery, and active surveillance are lacking.

AUA/ASTRO/SUO 2022 guideline, amended 2026; Expert Opinion.

High-risk disease: Whole-gland or focal ablation should not be recommended for patients with high-risk prostate cancer outside of a clinical trial.Outside a clinical trial

AUA/ASTRO/SUO 2022 guideline, amended 2026; Expert Opinion.

Routine primary therapy: Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer because long-term data comparing these treatments with radiation or radical prostatectomy are lacking.

NCCN Prostate Cancer Version 5.2026.

Current literature and professional societies do not support transurethral water vapor thermal therapy for the treatment of prostate cancer. The technique uses radiofrequency-generated sterile water vapor at approximately 103°C to produce thermal injury, cell death, and necrosis in prostate tissue; however, the policy does not identify supporting evidence for its use in prostate cancer.

Applicable Procedure and Diagnosis Codes

CPT CodesCPT

55873	Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring).
55880	Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance.
55899	Unlisted procedure, male genital system.

CPT Codes — Experimental/InvestigationalCPTExperimental

55877	Ablation, irreversible electroporation, prostate, 1 or more tumors, including imaging guidance, percutaneous (Effective 01/01/26). E/I
0582T	Transurethral ablation of malignant prostate tissue by high-energy water vapor thermotherapy, including intraoperative imaging and needle guidance. E/I
0601T	Ablation, irreversible electroporation; 1 or more tumors, including fluoroscopic and ultrasound guidance, when performed, open. E/I
0655T	Transperineal focal laser ablation of malignant prostate tissue, including transrectal imaging guidance, with MR-fused images or other enhanced ultrasound imaging. E/I
0738T	Treatment planning for magnetic field induction ablation of malignant prostate tissue, using data from previously performed magnetic resonance imaging (MRI) examination. E/I
0739T	Ablation of malignant prostate tissue by magnetic field induction, including all intraprocedural, transperineal needle/catheter placement for nanoparticle installation and intraprocedural temperature monitoring, thermal dosimetry, bladder irrigation, and magnetic field nanoparticle activation. E/I

HCPCS CodesHCPCS

C2618

Probe/needle, cryoablation

ICD10 CodesICD-10

C61	Malignant neoplasm of prostate.
C79.82	Secondary malignant neoplasm of genital organs.
D07.5	Carcinoma in situ of prostate.
R97.21	Rising PSA following treatment for malignant neoplasm of prostate.
Z85.46	Personal history of malignant neoplasm of prostate.
Z92.3	Personal history of irradiation.

ICD-10 CodesICD-10

C61	Malignant neoplasm of prostate
C79.82	Secondary malignant neoplasm of genital organs
D07.5	Carcinoma in situ of prostate
R97.21	Rising PSA following treatment for malignant neoplasm of prostate
Z85.46	Personal history of malignant neoplasm of prostate
Z92.3	Personal history of irradiation

Code Edit AddedCPT

55877

Documentation and Coverage Decision Risks

Documentation Required

Document Recurrence and Nonmetastatic Status

Before approving cryosurgery or high-intensity focused ultrasound (HIFU) for recurrent prostate cancer, document recurrence after radiation therapy with a positive repeat biopsy and confirm absence of metastatic disease.

Recurrent prostate cancer after radiation therapy must be supported by a positive, repeat biopsy.
Absence of metastatic disease must be documented.

Denial Risk

Routine Primary Focal Therapy Is Investigational

Cryotherapy or other focal therapies, including HIFU, performed as routine primary therapy for localized prostate cancer are considered investigational and may be denied.

Applies to routine primary treatment of localized prostate cancer.

Focal Therapy Overview

Cryosurgical ablation uses transrectal ultrasound-guided, percutaneous cryoprobes to freeze prostate tissue and create well-demarcated areas of cellular injury and destruction. High-intensity focused ultrasound (HIFU) uses a transrectal probe to deliver and monitor precisely focused ultrasound energy, producing tumor-cell necrosis without radiation or surgical excision. The policy identifies cryosurgery and HIFU as potential local treatment approaches for selected biopsy-confirmed recurrent prostate cancer after radiation therapy when metastatic disease is absent; routine primary focal treatment of localized prostate cancer remains investigational.

Therapy Definitions

Cryosurgical ablation

DefinitionAn alternative treatment for prostate cancer using transrectal, ultrasound-guided, percutaneous cryoprobes.

MechanismThe cryoprobes freeze prostate tissue, producing well-demarcated areas of cell injury and destruction.

GuidanceTransrectal ultrasonography is used to guide cryoprobe placement.

High-intensity focused ultrasound (HIFU)

DefinitionA noninvasive or minimally invasive technique that uses precisely delivered ultrasound energy to achieve tumor cell necrosis.

MechanismFocused ultrasound energy causes tumor cell necrosis without radiation or surgical excision.

Policy Summary

PayerExcellus Health Plan Inc

PolicyFocal Therapies for Prostate Cancer Treatment

Policy CodePolicy 7.01.01

Change TypeModified

Effective DateAugust 20, 2026

Next Review DateAugust 1, 2027

Key ActionDocument recurrence after radiation therapy with a positive repeat biopsy and confirm absence of metastatic disease for cryosurgery or HIFU.

SourceLink

On This Page

Radiotherapy recurrence: Cryosurgery and HIFU are identified as local therapy options for radiotherapy recurrence when metastatic disease is absent.Absence of metastatic disease

NCCN Prostate Cancer Version 5.2026.

Do not represent routine primary cryotherapy, HIFU, or other focal therapy as medically necessary under this policy.

Denial Risk

Specified Focal Modalities Are Investigational

The following focal therapies for routine treatment of prostate cancer are considered investigational. The list is not exhaustive.

Vascular-targeted photodynamic therapy (VTP).
High-energy water vapor thermotherapy.

Denial Risk

High-Risk Disease Requires a Clinical Trial

Do not recommend whole-gland or focal ablation for patients with high-risk prostate cancer outside of a clinical trial, consistent with the AUA/ASTRO/SUO guideline recommendation.

High-risk prostate cancer: whole-gland and focal ablation should not be recommended outside a clinical trial.
Consider clinical-trial enrollment rather than routine ablation.

A transrectal probe plans, performs, and monitors treatment in real time; treatment may target the entire prostate gland or small discrete lesions.

Vascular-targeted photodynamic therapy (VTP/PDT)

DefinitionA tissue-preserving treatment for low-risk prostate cancer using intravenous padeliporfin and optical fibers inserted into the prostate.

Treatment doseIntravenous padeliporfin is administered at 4 mg/kg over 10 minutes.

MechanismOptical fibers cover the desired treatment zone and are activated by laser light; the photosensitizer used is TOOKAD soluble (WST11).

Irreversible electroporation (IRE)

DefinitionA focal therapy that targets areas of significant tumor burden to ablate tumors in situ or improve resection margins.

MechanismShort electrical pulses disrupt cell-membrane phospholipids and destroy tumors without thermal heat.

Clinical useIRE is used for tumors of the pancreas, kidney, liver, and prostate.

Vascular-targeted photodynamic therapy (VTP/PDT)

DefinitionA tissue-preserving treatment for low-risk prostate cancer using intravenous padeliporfin followed by laser activation through optical fibers inserted into the prostate.

Treatment dosePadeliporfin is administered intravenously at 4 mg/kg over 10 minutes.

MechanismOptical fibers are positioned to cover the desired treatment zone and activated with laser light; this treatment is also called TOOKAD Soluble VTP therapy.

Irreversible electroporation (IRE)

DefinitionA focal ablation technique used to target significant tumor burden, including tumors in situ or resection margins.

MechanismShort electrical pulses disrupt cell-membrane phospholipids without generating thermal heat.

DeviceThe NanoKnife System is identified for surgical ablation of soft-tissue tumors.

Laser interstitial thermotherapy (LITT)

DefinitionA focal thermal ablation treatment.

MechanismLITT produces lesion cytoreduction through tissue coagulation, necrosis, and cellular apoptosis.

Treatment effectThe treatment uses thermal energy to produce a localized ablation lesion.

Trans-urethral ultrasound ablation (TULSA)

DefinitionA transurethral prostate tissue ablation system.

Imaging and deliveryTULSA uses real-time MRI and robotically driven, directional thermal ultrasound.

Thermal controlClosed-loop temperature feedback control software regulates treatment; the system can ablate the whole or part of the prostate while protecting the urethra and rectum.

Magnetic field induction (NanoTherm therapy)

DefinitionA therapy using magnetic nanoparticles injected into a tumor or applied at the wall of a tumor resection cavity.

NanoparticlesThe particles contain iron oxide.

Activation mechanismAn externally applied, rapidly alternating magnetic field activates the particles and generates heat during NanoActivator treatment sessions.

Transurethral water vapor thermal therapy

DefinitionA transurethral needle ablation technique that injects radiofrequency-generated sterile water vapor into enlarged prostate tissue.

Temperature and mechanismWater vapor at approximately 103°C condenses in prostatic tissue, releasing thermal energy that disrupts cell membranes and causes cell death and necrosis.

Policy-relevant statusThe document states that no literature or professional society currently supports this therapy for prostate cancer.