Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

220.6.6

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

1. Evaluation of Recurrent Melanoma Prior to Surgery As Alternative to Gallium Scan (Effective July 1, 1999)

Effective for services performed on or after July 1, 1999, FDG PET (when used as an alternative to a Gallium scan) is covered for patients with recurrent melanoma prior to surgery for tumor evaluation. FDG PET is not covered for the evaluation of regional nodes.

Frequency Limitations: Whole body PET scans cannot be ordered more frequently than once every 12 months, unless medical necessity documentation, maintained in the beneficiary's medical record, supports the specific need for anatomic localization of possible recurrent tumor within this period.

Limitations: The FDG PET scan is covered only as an alternative to a Gallium scan. PET scans can not be covered in cases where they are performed within 50 days of a Gallium scan performed by the same PET facility where the patient has remained under the care of the same facility during the 50-day period. Gallium scans performed by another facility less than 50 days prior to the PET scan will not be counted against this screen. The purpose of this screen is to ensure that PET scans are covered only as an alternative to a Gallium scan within the same facility. The CMS is aware that, in order to ensure proper patient care, the treating physician may conclude that previously performed Gallium scans are either inconclusive or not sufficiently reliable to make the determination covered by this provision. Therefore, CMS will apply this 50-day rule only to PET scans performed by the same facility that performed the Gallium scan.

Effective for services performed on or after July 1, 2001, documentation should be maintained in the beneficiary's medical file at the referring physician's office to support the medical necessity of the procedure, as is normal business practice.

2. Diagnosis, Staging, and Restaging (Effective July 1, 2001)

Effective for services performed on or after July 1, 2001, FDG PET is covered for the diagnosis, staging, and restaging of melanoma. FDG PET is not covered for the evaluation of regional nodes.

3. Monitoring Response to Treatment (Effective January 28, 2005)

Effective for services performed on or after January 28, 2005, Medicare only covers FDG PET for monitoring response to treatment for melanoma 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.hhs.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 the 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 file, 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 melanoma as "coverage with evidence development". Effective date 01/28/05. Implementation date 04/18/05. (TN 31) (CR 3741)