Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

220.6.7

Version Number

Effective Date of this Version

1/28/2005

Ending Effective Date of this Version

4/3/2009

Implementation Date

4/18/2005

Benefit Category

Diagnostic Tests (other)

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

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:

Federal Register Notice
CMS coverage Web site at: www.cms.gov/center/coverage.asp

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

A. 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.

B. 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.

C. 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).

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/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)