National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography (FDG) for Cervical Cancer

CAG-00181R2

Issue

Positron emission tomography (PET) is a non-invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues in the human body. Images are obtained by processing of emissions from positron-emitting radioisotopes that are usually administered intravenously. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is the radioisotope commonly used in oncologic FDG PET imaging procedures.

There are approximately 11,000 new cases of cervical cancer and almost 4000 deaths annually in the US. Widespread screening of cervical cytology (Papanicolaou screening) has significantly reduced the frequency and burden of this disease. Treatment recommendations for cervical cancer depend on the stage of the cancer, which in turn depends on its anatomic spread and other factors.

The cervix is easily accessible for routine examination, and the diagnosis of cancer is readily made by biopsy of the cervix. There are several methods to determine the extent of disease, and these may include surgical exploration, endoscopic procedures or complex medical imaging.

Medicare already nationally covers FDG PET when it is used by the beneficiary's physician to guide the subsequent management of cervical cancer in women who have undergone anticancer treatment. For example, FDG PET is covered to determine whether or not the cancer has responded to treatment or to determine if the patient's symptoms are being caused by a recurrence or spreading of the cancer.

FDG PET is also already nationally covered for some uses in women diagnosed with cervical cancer who have not yet received anticancer treatment. Specifically, FDG PET imaging is covered as an adjunct test for the detection of pre-treatment metastasis (i.e., staging) in newly diagnosed cervical cancers following conventional imaging that is negative for extra-pelvic metastasis.

Medicare coverage of all other uses of FDG PET related to cervical cancer is restricted to beneficiaries who are enrolled in a prospective clinical study under Coverage with Evidence Development (CED).

The requestors have asked CMS to reconsider the NCD and nationally cover FDG PET more broadly (without the CED restriction) for the staging of cervical cancer, i.e. in those women who have been diagnosed with cervical cancer but who do not otherwise meet the coverage criteria. The requestors also ask that the use of FDG PET be nationally noncovered to make the diagnosis of cervical cancer, as FDG PET imaging is not helpful to make the initial diagnosis.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
See Actions Taken View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
05/08/2009
Expected NCA Completion Date
11/11/2009
Public Comment Period
05/08/2009 - 06/07/2009
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/13/2009
Proposed Decision Memo Public Comment Period
08/13/2009 - 09/12/2009
Decision Memo Released
11/10/2009
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Stuart Caplan, RN, MAS
Katherine Tillman, RN, MA
Lead Medical Officers
Jeffrey Roche, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

May 08, 2009

REQUESTORS:

Perry W. Grigsby, MD, MBA Professor of Radiation Oncology and Radiology

Barry A. Siegel, MD Chief, Division of Nuclear Medicine Mallinckrodt Institute of Radiology Professor, Department of Radiology Washington University School of Medicine

CMS opens this reconsideration of the NCD on Positron Emission Tomography (FDG). The formal request is to remove the current CED requirement for FDG PET imaging for cervical cancer in Section 220.17 of the NCD Manual. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

To submit a comment, please use the orange "COMMENT" button at the top of the page.

August 13, 2009

Posted proposed decision memo.

The 30-day public comment period begins with this posting date, and ends after 30 calendar days.

Instructions on submitting comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage .

To submit a comment, please use the orange "COMMENT " button at the top of the page.

November 10, 2009