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CMS posts results from Advisory Panel Meeting on the evidence to expand PET coverage for oncology indications

September 2, 2008


A public meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) was held on August 20, 2008. MedCAC provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute.The panel reviewed the scientific evidence of the impact of FDG-PET as part of a cancer management strategy to improve patient-centered outcomes. The panel also considered data generated under the current national coverage determination that provides coverage of FDG-PET for specified cancers when additional data are prospectively collected (i.e. National Onocologic PET Registry). The meeting was focused on the oncologic indications of FDG-PET for nine cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney).

A key component of the meeting was that the panel was asked to vote on a series of five panel voting questions. The questions and overall voting results are as follows:

Note: The questions were scored with a scale of 1= no confidence, 2= little confidence, 3= equivocal, 4= moderate confidence, 5= high confidence.
  1. How confident are you that the evidence is adequate to conclude that FDG-PET imaging improves physician decision making when used for the following indications for each in these nine cancers?

    Overall Average Scores:
    Diagnosis Staging Restaging Monitoring
    Bladder 1.71 2.57 2.57 2.83
    Brain 2.29 1.60 2.29 2.83
    Cervix 2.43 3.86 4.29 4.17
    Kidney 3.00 3.57 2.86 3.14
    Ovary 3.43 3.71 4.29 4.00
    Pancreas 3.43 3.71 3.17 3.33
    Prostate 1.57 2.00 2.33 2.00
    Small Cell Lung 2.14 2.71 2.57 2.29
    Testis 1.86 1.86 2.00 1.71

  2. How confident are you that the evidence is adequate to conclude that FDG-PET imaging improves patient oriented clinical outcomes when used for the following indications in each of the nine cancers?

    Overall Average Scores:
    Diagnosis Staging Restaging Monitoring
    Bladder 1.43 1.86 2.00 2.33
    Brain 2.00 2.00 2.83 2.67
    Cervix 2.00 3.14 3.57 3.83
    Kidney 2.14 2.43 2.43 2.50
    Ovary 2.86 3.29 3.29 3.33
    Pancreas 3.00 3.14 2.86 2.50
    Prostate 1.43 1.71 1.86 1.83
    Small Cell Lung 2.00 2.57 2.43 2.50
    Testis 1.86 1.86 1.86 1.83

  3. How confident are you that these conclusions are generalizable to other cancers? Overall Average Score = 2.86
  4. How confident are you that these conclusions are generalizable to non-research PET facilities in the general community? Overall Average Score = 3.71
  5. How confident that these conclusions are generalizable to the Medicare beneficiary population? Overall Average Score = 4.14

(The results of the panel votes can be found in the scoresheet posted at: www.cms.hhs.gov/mcd/viewmcac.asp?id=218)

The committee’s assessment will be considered by the Centers for Medicare and Medicaid Services (CMS) as they continue their deliberations of potentially expanding the nationally covered indications for FDG-PET.

Background:
On April 10, 2008 CMS opened a National Coverage Analysis (NCA): FDG-PET for brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers (CAG-00181R).
The NCA was opened in response to a formal request submitted to CMS by the National Oncologic PET Registry (NOPR) to reconsider FDG PET coverage as set forth in the National Coverage Determinations (NCD) Manual Section 220.6 – PET Scans. Specifically, the request is to end the current prospective data collection requirements as required for FDG-PET used in the diagnosis, staging and restaging of brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers, as well as for other cancer indications that are only covered through the NOPR. The MedCAC meeting was convened as part of the decision making process by CMS.

Decision due dates:
The proposed decision memo due date is January 10, 2009.

The expected NCA completion date (i.e. final decision) is April 9, 2009.

The home page for the NCA can be found at:
www.cms.hhs.gov

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