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National Coverage Determination (NCD)

PET (FDG) for Head and Neck Cancers

220.6.7

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Tracking Information

Publication Number
100-3
Manual Section Number
220.6.7
Manual Section Title
PET (FDG) for Head and Neck Cancers
Version Number
1
Effective Date of this Version
01/28/2005
Ending Effective Date of this Version
04/03/2009
Implementation Date
04/18/2005
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Tests (other)


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description
Indications and Limitations of Coverage

Effective for services performed on or after July 1, 2001, Medicare covers FDG PET for diagnosis, staging and restaging of cancer of the head and neck, excluding the central nervous system (CNS) and thyroid. The head and neck cancers encompass a diverse set of malignancies of which the majority is squamous cell carcinomas. Patients may present with metastases to cervical lymph nodes but conventional forms of diagnostic imaging fail to identify the primary tumor. Patients that present with cancer of the head and neck are left with two options - either to have a neck dissection or to have radiation of both sides of the neck with random biopsies. PET scanning attempts to reveal the site of primary tumor to prevent the adverse effects of random biopsies or unnecessary radiation.

Limitations: PET scans for head and neck cancers are not covered for CNS or thyroid cancers prior to October 1, 2003. Refer to section 220.6.11 for coverage for thyroid cancer effective October 1, 2003.

Effective for services performed on or after January 28, 2005, Medicare only covers FDG PET for monitoring response to treatment for head and neck cancers as "coverage with evidence development".

Medicare shall notify providers and beneficiaries where these services can be accessed, as they become available, via the following:

Requirements: PET is covered in any/all of the following circumstances:

  1. Diagnosis: PET is covered only in clinical situations in which: (1) the PET results may assist in avoiding an invasive diagnostic procedure, or (2) the PET results may assist in determining the optimal anatomical location to perform an invasive diagnostic procedure. In general, for most solid tumors a tissue diagnosis is made prior to the performance of PET scanning. PET scans following a tissue diagnosis are generally performed for staging rather than diagnosis.

  2. Staging and/or Restaging: PET is covered for staging in clinical situations in which: (1)(a) the stage of the cancer remains in doubt after completion of a standard diagnostic workup, including conventional imaging (computed tomography, magnetic resonance imaging, or ultrasound), or (1)(b) the use of PET could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient, and (2) clinical management of the patient would differ depending on the stage of the cancer identified.

    PET is covered for restaging after completion of treatment for the purpose of: (1) detecting residual disease, (2) detecting suspected recurrence, (3) determining the extent of a known recurrence, or (4) potentially replacing one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient.

  3. Monitoring Response to Treatment: PET is covered for monitoring response to treatment when a change in therapy is anticipated.

Documentation that these conditions are met should be maintained by the referring physician in the beneficiary's medical record, as is normal business practice.

(This NCD last reviewed March 2005.)
Cross Reference

See NCD for PET Scans (§220.6).
Claims Processing Instructions

Transmittal Information

Transmittal Number
31
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R31NCD.pdf
Revision History

04/2005 - Covered for monitoring response to treatment for head and neck cancers as "coverage with evidence development". Effective date 01/28/05. Implementation date 04/18/05. (TN 31) (CR 3741)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
FDG PET for Head and Neck Cancers (Replaced with Section 220.6.17) - RETIRED 3 04/10/2023 - N/A View
FDG PET for Head and Neck Cancers (Replaced with Section 220.6.17) 2 04/03/2009 - 04/10/2023 View
PET (FDG) for Head and Neck Cancers 1 01/28/2005 - 04/03/2009 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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