Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

220.6.5

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, 1999, FDG PET is covered for the staging and restaging of lymphoma.

Requirements:

PET is covered only for staging or follow-up restaging of lymphoma. Claims must include a statement or other evidence of previous diagnosis of lymphoma when used as an alternative to a Gallium scan.
To ensure that the PET scan is properly coordinated with other diagnostic modalities, claims must include the results of concurrent computed tomography (CT) and/or other diagnostic modalities necessary for additional anatomic information.
In order to ensure that the PET scan is covered only as an alternative to a Gallium scan, no PET scan may be covered in cases where it is performed within 50 days of a Gallium scan performed by the same facility where the patient has remained 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.

Frequency Limitation for Restaging: PET scans will be allowed for restaging no sooner than 50 days following the last staging PET scan or Gallium scan, unless sufficient evidence is presented to convince the Medicare contractor that restaging at an earlier date is medically necessary. Since PET scans for restaging are generally performed following cycles of chemotherapy, and since such cycles usually take at least 8 weeks, CMS believe s this screen will adequately prevent medically unnecessary scans while allowing some adjustments for unusual cases. In all cases, the determination of the medical necessity for a PET scan for re-staging lymphoma is the responsibility of the local Medicare contractor.

Effective for services performed on or after July 1, 2001, documentation should be maintained in the beneficiary's medical record 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, Medicare covers FDG PET for the diagnosis, staging and restaging of lymphoma.

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 lymphoma 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 the 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 (CT, 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 lymphoma as "coverage with evidence development". Effective date 01/28/05. Implementation date 04/18/05. (TN 31) (CR 3741)