CMS Publishes Draft PET Coverage Decision

January 7, 2009

CMS Publishes Draft PET Coverage Decision

CMS Press Release

On Tuesday, January 6, 2009, the Centers for Medicare and Medicaid Services (CMS) released their preliminary PET Coverage Decision. There are two critical draft decisions that are included:

1). CMS Expands Coverage for the Initial Treatment Strategy

CMS proposes that the evidence is adequate to determine that the results of FDG PET imaging are useful in determining the appropriate initial treatment strategy for patients with suspected solid tumors. Therefore, CMS will cover one FDG PET study for patients who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the patient’s physician determines FDG PET is critical to determine the location and/or extent of the tumor for the following therapeutic purposes:

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.

2). CMS Continues to Restrict Coverage on the Subsequent Treatment Strategy and Proposes New Coverage Framework.

CMS proposes, for tumors other than the nine currently cover tumors: breast, cervix, colorectal, esophagus, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid, that the available evidence is not adequate to determine that FDG PET imaging improves physician decision making in the determination of subsequent anti-tumor treatment strategy.

Also, CMS proposes to transition the current framework- diagnosis, staging, restaging and monitoring- into the initial treatment and subsequent treatment strategy framework while maintaining current coverage. See the below Appendix A of the draft decision for a summation of the effects of these changes.

Stay tuned for more from the SNM as we review these materials carefully.

Appendix A: Effect of Coverage Changes on Oncologic Uses of FDG PET

	Current Framework				Proposed Framework
Solid Tumor Type	Diagnosis	Staging	Restaging	Monitoring	Initial Treatment *	Subsequent Treatment **
Brain	CED	CED	CED	CED	Cover	CED
Breast (female and male)	N/C	1	Cover	Cover	1	Cover
Cervix	CED	Cover	Cover	CED	Cover	Cover
Colorectal	Cover	Cover	Cover	CED	Cover	Cover
Esophagus	Cover	Cover	Cover	CED	Cover	Cover
Head & Neck (not thyroid or CNS)	Cover	Cover	Cover	CED	Cover	Cover
Lymphoma	Cover	Cover	Cover	CED	Cover	Cover
Melanoma	Cover	2	Cover	CED	2	Cover
Non-small cell lung	Cover	Cover	Cover	CED	Cover	Cover
Ovary	CED	CED	CED	CED	Cover	CED
Pancreas	CED	CED	CED	CED	Cover	CED
Prostate	CED	CED	CED	CED	N/C	CED
Small cell lung	CED	CED	CED	CED	Cover	CED
Soft Tissue Sarcoma	CED	CED	CED	CED	Cover	CED
Thyroid	CED	CED	3	CED	Cover	3
Testes	CED	CED	CED	CED	Cover	CED
All other solid tumors	CED	CED	CED	CED	Cover	CED

* Formerly "diagnosis" and "staging"
** Formerly "restaging" and "monitoring response to treatment when a change in treatment is anticipated"
N/C = noncover

(1) Breast: Covered for initial staging of metastatic disease. Noncovered for initial staging of axillary lymph nodes.
(2) Melanoma: Noncovered for initial staging of regional lymph nodes
(3) Thyroid: Covered for restaging of follicular cell types

Review the full report

Public Comments are due by February 5, 2009 and the Final National Coverage Determination will be released in April 2009.

Submit a comment (click on the orange "comment" button at the top)

CMS is specifically interested in comments on the following questions:

Should the current framework for evaluating the use of FDG PET imaging be modified as proposed?
Does the evidence support the broad expansion of coverage of FDG PET imaging to all solid tumors when determining initial treatment strategy?
Does the evidence support the restriction of coverage of FDG PET imaging in solid tumors when determining subsequent treatment strategy to coverage with evidence development?
For breast cancer and melanoma that have noncoverage for initial treatment strategy, is there evidence that would support their removal from the list of exceptions to coverage for initial treatment strategy?
For the nine cancers that have coverage for subsequent treatment strategy, is there evidence that would support restricting their coverage to CED?

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