Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.

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Cryoablation Page: 2 of 17

NCD

• Cryosurgery of prostate

Description

Cryoablation (also known as cryotherapy or cryosurgery) involves the internal or external use of liquid nitrogen or argon gas at extreme cold temperatures to destroy diseased tissue. For external uses, the liquid nitrogen is applied directly with a cotton swab or spray device. For internal purposes, either argon gas or liquid nitrogen is circulated through a cryoprobe that has been situated next to diseased tissue via image guidance, such as ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT), which reportedly ensures less damage to nearby healthy tissue. Ice crystals form around the probe, which freezes the cells. Once the cells thaw, the body absorbs them. Cryoablation may be used to treat several types of cancer including, but may not be limited to, cervical, kidney, liver and prostate. Cryoablation has also been used in precancerous conditions to avoid the development of cancer (eg, cervical intraepithelial neoplasia [CIN]).

Cryoablation may be utilized for the treatment of cutaneous (superficial) basal cell carcinoma (BCC) and squamous cell carcinoma in situ (Bowen disease) in which surgery is contraindicated. Choice of treatment depends on factors such as anatomic location, risk factors for tumor recurrence, age and health status of the individual.

Cryoablation may purportedly be utilized for the treatment of cutaneous melanoma; however, data appears to be insufficient to support its use for this indication.

Other areas being studied for the use of cryoablation include, but may not be limited to, Barrett’s esophagus, bone tumors, breast cancer, breast fibroadenomas, esophageal cancer, pulmonary tumors, non- small cell lung cancer (NSCLC) as well as thyroid cancer.

Cryotherapy is proposed for the use of ocular conditions such as retinal detachment. This treatment is designed to create scar tissue, which will seal the tear or help the retina reattach to the underlying tissue to keep it in the correct position.

Cryotherapy is being investigated for the treatment of uveal melanoma, retinopathy (eg, diabetic retinopathy, retinopathy of prematurity) or conjunctival lesions.

Cryoablation is also being investigated for the treatment of chronic rhinitis.

The treatment is designed to destroy unwanted tissue and to purportedly interrupt nerve signals in the nose to reduce rhinitis symptoms (eg, ClariFix).

Cryoablation has also been used for noncancerous conditions such as atrial fibrillation, benign prostatic hyperplasia, benign skin lesions, chronic nerve pain, chronic spinal pain, plantar fasciitis, uterine fibroids and varicose veins.

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Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

• Cryoablation will be considered medically reasonable and necessary when the following requirements are met:
• Cervical intraepithelial neoplasia (CIN) grade 1, 2 or 3 in an individual who is not pregnant; OR
• Endometrial cryoablation for premenopausal women with menorrhagia (excessive bleeding) not related to uterine fibroids and whom childbearing is complete and are refractory to medical treatment; OR
• Localized, cutaneous (superficial) BCC in which surgery or radiation therapy is contraindicated;60 OR
• Localized, cutaneous (superficial) squamous cell carcinoma in situ (Bowen disease) in which surgery is contraindicated;72 OR
• Malignant endobronchial obstruction in a symptomatic individual68; OR
• Prostate cancer as a primary therapy in an individual with localized disease (eg, TNM stage T1-T3) who is not suitable for surgery or irradiation due to comorbidities22,26 OR as salvage therapy for recurrent cancer following failure of radiation therapy and who are either stage T2B or below or Gleason less than 9, PSA less than 827,69; OR
• Renal cell cancer in an individual with stage T1 renal lesions <3 cm who is not amenable to surgery26,66,96; OR
• Retinal detachment8; OR
• Soft tissue sarcoma of the extremities or the trunk in a symptomatic individual with disseminated metastases71; OR
• Unresectable malignant primary or metastatic liver tumors64

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

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Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

Cryoablation will not be considered medically reasonable and necessary:

• Bone tumors (primary)
• Conjunctival lesions
• Diabetic retinopathy
• Morton’s neuromas
• Peripheral neuropathy
• Pancreatic cancer
• Plantar fasciitis
• Thyroid cancer
• Uveal melanoma

A review of the current medical literature shows that there is no evidence to determine that these services are standard medical treatments. There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.

Cryoablation indications will not be considered medically reasonable and necessary:

• Barrett’s esophagus/Esophageal cancer; OR
• Breast cancer; OR
• Breast fibroadenomas; OR
• Chronic rhinitis (eg, ClariFix); OR
• Cutaneous melanoma; OR
• Pulmonary tumors (eg, NSCLC); OR

A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment.

Summary of Evidence

Barrett's Esophagus (BE)/Esophageal Cancer

A report of 2 systematic reviews of low-quality studies were of high risk of bias to support conclusions. Cryoablation differs from radiofrequency ablation (RFA) as it induces intracellular ice crystal formation, which reportedly causes no permanent change in protein structure. This may preserve the architecture of the extra-cellular collagen matrix. However, the clinical advantages of cryoablation for the treatment of BE has not been fully established. There are currently no randomized trials that address the efficacy of cryoablation for dysplastic BE. The current literature is inadequate to recommend endoscopic eradication therapies utilizing cryotherapy for individuals with low-grade dysplasia or high-grade dysplasia with BE.

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Breast Cancer

According to the research, cryoablation is currently FDA approved for treatment of benign and malignant soft tissue. There are not specific techniques that are FDA approved for breast tumors. As the data emerges on its efficacy, it is advised to participate in registries and clinical trials that evaluates the use of this technology with and without surgical excision of a breast malignancy.

Breast Fibroadenoma

Definitive conclusions regarding the efficacy and overall benefit for the use of cryoablation for breast fibroadenomas cannot be concluded due to the limitations of the available studies.

Chronic Rhinitis

Studies have shown symptom relief for chronic rhinitis at 1 year follow-up. However, whether results can be sustained in the long term cannot be determined. Available studies are needed. There are no studies that compare cryoablation with other clinical treatments for the treatment of rhinitis.

Cutaneous Melanoma

The research supports the use of cryoablation for SC and BCC (see Coverage Determination); however, it should not be used to treat melanoma, including melanoma in situ.

Lung Cancer

The evidence supports the use of cryoablation for the treatment of endobronchial obstruction (see Coverage Determination) and suggested for use as treatment when surgical resection is not an option. However, additional studies are needed to assess safety and long-term efficacy of cryoablation as compared to other established treatments for lung cancer. RFA is the most studies technique for non-small cell lung cancer (NSCLC), but other approaches are under development, which include microwave ablation, laser ablation and cryoablation.