Humana Electric Tumor Treatment Fields - Medicare Advantage Form
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Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.
Jurisdiction Medicare Administrative Contractors (MACs)
Geographical States/Territories
- Noridian Healthcare Solutions LLC (DME MAC)
- Palmetto GBA, LLC (DME MAC) - CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT; MN, OH, WI
- LCD LCA - Tumor Treatment Field Therapy (TTFT)
- L34823 A52711
- CGS Administrators, LLC (DME MAC) - AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI
- Meridien Healthcare Solutions LLC (DME MAC) - AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands
AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands
DME D - Noridian Healthcare Solutions, LLC (DME MAC)
Electric Tumor Treatment Fields Page: 3 of 5
Description
Electric tumor treatment fields (ETTFs) are created by low intensity, alternating intermediate frequency (200 kilohertz [kHz]) electric currents that are delivered to a malignant tumor site via insulated electrodes placed around the region of the body containing the tumor.
ETTFs have been US Food & Drug Administration (FDA) approved for the following indications:
- Combined ETTF and temozolomide in an individual with histologically confirmed newly diagnosed glioblastoma multiforme (GBM) (also known as World Health Organization [WHO] grade IV astrocytoma) limited to the supratentorial region following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy
- In an adult individual with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy
- Monotherapy in an adult with histologically or radiologically confirmed recurrent supratentorial GBM (also known as WHO grade IV astrocytoma) following chemotherapy after surgery and radiation treatments have been exhausted
When utilized for GBM, the application of ETTFs to the surface of the scalp disrupts the rapid division of cancer cells within the brain while sparing nonproliferating brain tissue and the normal rate of cell division. An example of an FDA-approved ETTF device for the treatment of GBM includes, but may not be limited to, Optune (formerly known as the Novo TTF-100A System).
When used for MPM, 4 electrically insulated electrode arrays are placed on the thorax along with intravenous administration of pemetrexed plus platinum-based chemotherapy to reportedly disrupt solid tumor cancer cell division. An example of a FDA-approved ETTF device for the treatment of MPM includes, but may not be limited to, the Optum Lau (formerly known as the NovoTTF - 100L System).
The ETTF devices are portable and battery operated. Treatment parameters are preset by the device manufacturer and no electrical output adjustments are available to the individual; however, they must learn to change and recharge depleted batteries. The individual must carry the device with them to receive continuous treatment, typically recommended for at least 18 hours per day for 4 weeks. Electrodes must be replaced every few days and the skin reshaved in order to maintain optimal contact.
The use of ETTFs in combination with atezolizumab and bevacizumab, is being studied for the treatment of liver cancer (NovoTTF-200T). However, it is not yet FDA-approved for this indication.
It is also being studied as adjunctive therapy for other non-FDA approved indications such as, breast cancer, gastric cancer, lung cancer, ovarian cancer and pancreatic adenocarcinoma.
Treatment planning software (eg, NovoTAL) is available and designed to be utilized prior to ETTF treatment. The software purportedly allows the physician to individualize treatment by determining optimal placement of the transducer arrays based on the individual’s most recent magnetic resonance imaging (MRI) scan, head size and tumor location.
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:
Electric Tumor Treatment Fields
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