Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

220.6.2

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. Characterization of Single Pulmonary Nodules (SPNs) (Effective January 1, 1998)

Effective for services performed on or after January 1, 1998, Medicare covers regional FDG PET chest scans, on any FDA-approved scanner, for the characterization of SPNs. The primary purpose of such characterization should be to determine the likelihood of malignancy in order to plan future management and treatment for the patient.

Beginning July 1, 2001, documentation should be maintained in the beneficiary's medical record file at the referring physician’s office to support the medical necessity of the procedure, as is normal business practice. The following documentation is required:

There must be evidence of primary tumor. Claims for regional PET chest scans for characterizing SPNs should include evidence of the initial detection of a primary lung tumor, usually by computed tomography (CT). This should include, but is not restricted to, a report on the results of such CT or other detection method, indicating an indeterminate or possibly malignant lesion, not exceeding 4 centimeters (cm) in diameter.
PET scan claims must include the results of concurrent thoracic CT (as noted above), which is necessary for anatomic information, in order to ensure that the PET scan is properly coordinated with other diagnostic modalities.
In cases of serial evaluation of SPNs using both CT and regional PET chest scanning, such PET scans will not be covered if repeated within 90 days following a negative PET scan.

NOTE: A tissue sampling procedure (TSP) is not routinely covered in the case of a negative PET scan for characterization of SPNs, since the patient is presumed not to have a malignant lesion, based upon PET scan results. When there is a negative PET, the provider must submit additional information with the claim to support the necessity of a TSP, for review by the Medicare contractor.

2. Initial Staging of Non-Small-Cell Lung Carcinoma (NSCLC) (Effective January 1, 1998)

Effective for services performed from January 1, 1998, through June 30, 2001, Medicare approved coverage of FDG PET for initial staging of NSCLC.

Limitations: This service is covered only when the primary cancerous lung tumor has been pathologically confirmed; claims for PET must include a statement or other evidence of the detection of such primary lung tumor. The evidence should include, but is not restricted to, a surgical pathology report, which documents the presence of an NSCLC. Whole body PET scan results and results of concurrent CT and follow-up lymph node biopsy must be properly coordinated with other diagnostic modalities. Claims must include both:

The results of concurrent thoracic CT, necessary for anatomic information, and
The results of any lymph node biopsy performed to finalize whether the patient will be a surgical candidate. The ordering physician is responsible for providing this biopsy result to the PET facility.

NOTE: Where the patient is considered a surgical candidate, (given the presumed absence of metastatic NSCLC unless medical review supports a determination of medical necessity of a biopsy) a lymph node biopsy will not be covered in the case of a negative CT and negative PET. A lymph node biopsy will be covered in all other cases, i.e., positive CT + positive PET; negative CT + positive PET; positive CT + negative PET.

3. Diagnosis, Staging, and Restaging of NSCLC (Effective July 1, 2001)

Effective for serviced performed on or after July 1, 2001, Medicare covers FDG PET for diagnosis, staging, and restaging of NSCLC.

4. Monitoring response to treatment of NSCLC (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 NSCLC 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 in which (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 (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 the completion of treatment for: (1) the purpose of 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 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.

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