There are no NCDs and/or LCDs for radiofrequency tumor ablation.

Description
Radiofrequency (RF) tumor ablation is a procedure in which a needle electrode is inserted via image guidance into a tumor (lesion) and electrical energy generates heat to destroy cancer cells. The current moves from the tip of the electrode into the surrounding tissue. The movement of ions results in frictional heating of the tissue and as the temperature becomes elevated beyond 60 degrees Celsius, cells around the electrode undergo necrosis (begin to die).

RF tumor ablation can be performed laparoscopically, percutaneously or intraoperatively; however, it is typically used for those individuals whose tumors are inoperable or for those who cannot undergo a surgical procedure due to age, presence of comorbidities or overall poor general health.

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 criteria contained in the following:

RF tumor ablation will be considered medically reasonable and necessary when the following requirements are met:

• Differentiated thyroid cancer for the following indications:
  1. Distant metastatic disease not amenable to radioactive iodine (RAI); OR
  2. Persistent/recurrent, nonmetastatic disease; OR
• Malignant painful bone tumors in an individual who has failed or cannot tolerate conventional treatments, such as medication or radiation therapy; OR
• Metastatic and nonmetastatic (primary) lung cancer in an individual who is not a candidate for surgical intervention; OR
• Nonmetastatic renal cancer in an individual who is not a candidate for surgical intervention; OR
• Osteoid osteoma in an individual who remains symptomatic despite treatment with nonsteroidal anti-inflammatory drugs (NSAIDs); OR
• Soft tissue sarcoma for the following indications:
  1. Gastrointestinal stromal tumors with limited progressive disease (defined as appearance of no new lesion or increase in tumor size); OR
  2. Synchronous stage IV soft tissue sarcoma with either of the following:
     1. Palliation of symptomatic disseminated metastases; OR
     2. Single organ and limited tumor bulk that are amenable to local therapies; OR
• Unresectable, metastatic hepatic tumors whose primary site is from colorectal cancer or neuroendocrine cancer; OR
• Unresectable primary malignant hepatic tumors less than or equal to 3 cm without nodal or extrahepatic metastases

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.

Coverage Limitations

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

The following services will not be considered medically reasonable and necessary:

• Metastatic hepatic tumors whose primary site is any other than colon/neuroendocrine/rectum
• Prostate cancer
• Spinal tumors/spinal metastases

A review of the current medical literature shows that there is no evidence to determine that this service is standard medical treatment for these indications.

There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management for these indications.

The following services will not be considered medically reasonable and necessary:

• Breast tumors

A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatments. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.

Summary of Evidence

Breast Tumors

At this time, there are no FDA approved percutaneous or transcutaneous ablative treatments for breast cancer. Techniques being under evaluation at this time includes ablation by focused ultrasound, laser, cryotherapy, microwave and radiofrequency.