Tumor Treatment Fields (TTF)

Policy ID: E-5-008

Section: Durable Medical Equipment

Effective Date: November 01, 2018

Revised Date: September 28, 2021

Revision Effective Date: November 01, 2021

Last Reviewed: September 21, 2021

Applies To: Commercial and Medicaid Expansion

Description

Electrical fields, known as "tumor treatment fields" (TTF), are created by low-intensity, alternating intermediate frequency (100-200 kilohertz [kHz]) electric currents delivered to the malignant tumor site by insulated electrodes placed on skin surface of the tumor site. As a result of the unique shape and electrical characteristics of dividing tumor cells, TTF exposure may damage the dividing cells through anti-microtubule mechanisms and could stop tumor growth while sparing normal tissue.

Criteria

TTF therapy to treat glioblastoma multiforme (GBM) may be considered medically necessary as an adjunct to standard maintenance therapy with temozolomide in individuals with newly diagnosed GBM following initial treatment with surgery, radiotherapy, and/or chemotherapy when ALL of the following criteria are met:

Adult individuals twenty-two (22) years or older; and
Supratentorial tumor; and
Karnofsky Performance Status(KPS) score greater than or equal to 60 and
Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the Food and Drug Administration, including wearing the device at least 18 hours daily.

Procedure Codes

A4555

E0766

TTF may be considered medically necessary for recurrent GBM when it is used as an alternative to standard medical therapy, as a monotherapy, following treatment with surgery, radiotherapy, and/or chemotherapy when ALL of the following criteria are met:

Adult individuals twenty-two (22) years or older; and
Supratentorial tumor; and
KPS score greater than or equal to 60 and
Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the Food and Drug Administration, including wearing the device at least 18 hours daily.

Procedure Codes

A4555

E0766

TTF may be considered medically necessary for continued use when ALL of the following criteria are met:

MRI scan or related imaging has been performed less than 2-4 months prior to request and documents no evidence of disease progression; and
KPS score of greater than 60; and
Documentation that the individual has been wearing the device at least 18 hours daily

Procedure Codes

A4555

E0766

TTF not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. Examples of conditions include but are not limited to the following.

Brain metastases
Cancer in areas other than the brain
As an adjunct to standard medical therapy (pemetrexed and platinum based chemotherapy) for individual with malignancy pleural mesothelioma.

Procedure Codes

A4555

E0766

NovoTAL Treatment Planning Software

NovoTAL is considered EXPERIMENTAL / INVESTIGATIVE due to lack of clinical evidence demonstrating an impact on improved health outcomes.

Procedure Codes

77299

KARNOFSKY PERFORMANCE STATUS (KPS)

A scale measuring the ability of individuals to perform ordinary tasks. KPS scores range from 0 to 100; a higher score means a person is better able to carry out daily activities.

KPS

Definition

100

Normal; no complaint; no evidence of disease

Able to carry on normal activity; minor signs of symptoms of disease

Normal activity with effort; some sign or symptoms of disease

Cares for self; unable to carry on normal activity of do active work

Requires occasional assistance, but is able to care for most personal needs

Requires considerable assistance and frequent medical care

Disabled; requires special care and assistance

Severely disabled; hospitalization is indicated, although death not imminent

Very sick; hospitalization necessary; active support treatment is necessary

Moribund; fatal processes progressing rapidly

Dead

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes A4555 and E0766

C71.0

C71.1

C71.2

C71.3

C71.4

C71.5

C71.6

C71.7

C71.8

C71.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Annual Review

Internal Medical Policy Committee 11-19-2020 mulitple revisions; broke criteria up into smaller sections, more defined.

Internal Medical Policy Committee 7-22-2021 Added statement regarding NovoTAL Treatment Planning Software and added Procedure code 77299

Internal Medical Policy Committee 9-21-2021 revision of clarifying language.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: E-5-007

Section: Durable Medical Equipment

Effective Date: November 01, 2018

Revised Date: June 29, 2021

Revision Effective Date: September 06, 2021

Last Reviewed: July 22, 2021

Archived Date:October 31, 2021

Applies To: Commercial Only

Description

Criteria

Adult individuals twenty-two (22) years or older; and
Supratentorial tumor; and
Karnofsky Performance Status(KPS) score greater than or equal to 60 and
Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the Food and Drug Administration, including wearing the device at least 18 hours daily.

Procedure Codes

A4555

E0766

Adult individuals twenty-two (22) years or older; and
Supratentorial tumor; and
KPS score greater than or equal to 60 and
Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the Food and Drug Administration, including wearing the device at least 18 hours daily.

Procedure Codes

A4555

E0766

TTF may be considered medically necessary for continued use when ALL of the following criteria are met:

MRI scan or related imaging has been performed less than 2-4 months prior to request and documents no evidence of disease progression; and
KPS score of greater than 60; and
Documentation that the individual has been wearing the device at least 18 hours daily

Procedure Codes

A4555

E0766

TTF isconsidered experimental/investigational for all other conditions and therefore, non-coveredbecause the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. Examples of conditions include but are not limited to the following.

Brain metastases
Cancer in areas other than the brain
As an adjunct to standard medical therapy (pemetrexed and platinum-based chemotherapy) for individual with malignancy pleural mesothelioma.

Procedure Codes

A4555

E0766

NovoTAL Treatment Planning Software

NovoTAL is considered EXPERIMENTAL / INVESTIGATIVE due to lack of clinical evidence demonstrating an impact on improved health outcomes.

Procedure Codes

77299

KPS

Definition

100

Normal; no complaint; no evidence of disease

Able to carry on normal activity; minor signs of symptoms of disease

Normal activity with effort; some sign or symptoms of disease

Cares for self; unable to carry on normal activity of do active work

Requires occasional assistance, but is able to care for most personal needs

Requires considerable assistance and frequent medical care

Disabled; requires special care and assistance

Severely disabled; hospitalization is indicated, although death not imminent

Very sick; hospitalization necessary; active support treatment is necessary

Moribund; fatal processes progressing rapidly

Dead

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes A4555 and E0766

C71.0

C71.1

C71.2

C71.3

C71.4

C71.5

C71.6

C71.7

C71.8

C71.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Annual Review

Internal Medical Policy Committee 11-19-2020 mulitple revisions; broke criteria up into smaller sections, more defined.

Internal Medical Policy Committee 7-22-2021 Added statement regarding NovoTAL Treatment Planning Software and added Procedure code 77299

Links

References (PDF)

Disclaimer

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Fargo, North Dakota 58121

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