FDG PET Rules Finalized, Effective April ’09

Long-discussed reconsideration of F-18 fluoro-D-glucose (FDG) positron emission tomography (PET) scanning of solid tumors and myelomas has been completed by the Centers for the Medicare & Medicaid Services (CMS). The changes, to be implemented Oct. 30 and retroactively effective to April 3, are extensive.

CMS is adopting a coverage framework that replaces the four-part diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework that differentiates FDG PET imaging used to inform the initial anti-tumor treatment strategy from other uses related to guiding subsequent antitumor treatment strategies after the completion of initial treatment. CMS is making this change for all national coverage determinations (NCDs) that address coverage of FDG PET for all oncologic conditions.

Medicare will cover one FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

New Coverage for Initial Treatment Strategy

Myeloma:

CMS will nationally cover the use of FDG PET imaging to determine initial treatment strategy in patients with myeloma.

Prostate:

CMS will nationally not cover the use of FDG PET imaging to determine initial treatment strategy in patients with adenocarcinoma of the prostate.

All other cancers not listed herein:

CMS will nationally cover the use of FDG PET imaging to determine initial treatment strategy in patients with all other cancers not listed herein provided under coverage with evidence development (CED).

Subsequent Treatment Strategy

CMS will not cover FDG PET imaging for subsequent anti-tumor treatment strategy for tumor types other than breast, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid, unless the FDG PET is provided under CED.

New Coverage for Subsequent Treatment Strategy

Ovarian:

CMS will nationally cover the use of FDG PET imaging to determine subsequent treatment strategy in patients with ovarian cancer.

Cervical:

CMS will nationally cover the use of FDG PET imaging to determine subsequent treatment strategy in patients with cervical cancer.

Myeloma:

CMS will nationally cover the use of FDG PET imaging to determine subsequent treatment strategy in patients with myeloma.

All other cancers not listed herein:

CMS will nationally cover the use of FDG PET imaging to determine subsequent treatment strategy in patients with all other cancers not listed herein provided under CED.

New Modifiers for PET

The two new FDG PET oncologic modifiers PI and PS were included in the July quarterly update of the IOCE, with an effective date of April 1, 2009. Upon implementation of this CR, all FDG PET oncologic-related claims for dates of service on or after April 3, 2009, must include one of these two new modifiers in order for the claim to be processed correctly:

PS – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary’s treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy. Short descriptor: PET tumor subsq tx strategy.

PI- Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing. Short descriptor: PET tumor init tx strat.

Specifically, the coverage for solid tumors and myleomas are as below:

*Coverage Change
**Coverage w/Exceptions

For more information, consult CMS transmittals R1833CP and R108NCD, issued Oct. 16.

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