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Update on the latest coverage announcement by the Centers for Medicare and Medicaid Services (CMS)
http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=92
The Centers for Medicare and Medicaid Services (CMS) recently posted the Draft Decision Memo for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N) – which includes their coverage decision for these 6 cancers that have been under review since March 2003 in addition to inviting comments for enrolling patients in one of three types of prospective clinical trials through a selection of registries.
Coverage decision:
u CMS has proposed that there is sufficient evidence to conclude that an FDG PET scan for the detection of pre-treatment metastases in newly diagnosed cervical cancer subsequent to negative conventional imaging would be reasonable and necessary, and CMS proposes to issue a national coverage determination (NCD) for this indication.
u CMS has proposed that the evidence is sufficient to conclude that an FDG PET scan for staging or detecting recurrent or residual disease in testicular cancer would not be reasonable and necessary, and CMS proposes to issue a national non-coverage determination for this indication.
u For all other indications in this decision memorandum, CMS has proposed that the evidence is sufficient to conclude that an FDG PET scan would be reasonable and necessary only when the provider is participating in and patients are offered enrollment in one of the following three types of prospective clinical studies.
The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on our proposed determinations related to the use of FDG PET as a diagnostic test for various forms of cancer. “We invite comments on the decision memorandum and on the proposal to establish a registry. We are specifically interested in the structure and function of that registry.”
CMS is accepting comments for 30 days from November 1, 2004.
All other previous positive national coverage determinations will remain in effect. (See Appendix C.)
All other previous national non-coverage determinations based on evidence of lack of benefit will remain in effect. (See Appendix C.)
http://www.cms.hhs.gov/coverage/download/id92.pdf
Appendix C
1. Covered nationally based on evidence of benefit. Refer to NCD Manual for specific coverage language. http://www.cms.hhs.fov/manuals/103_cov_determ/ncd103c1_part4.pdf 2. Non-covered nationally based on evidence of harm or no benefit 3. Non-covered nationally based on lace of evidence sufficient to establish either a benefit or harm or no prior decision addressing this cancer. Now termed “coverage under protocol”. *Monitoring = monitoring response to treatment when a change in therapy is anticipated.
Appendix C (continued)
1. Covered nationally based on evidence of benefit. Refer to NCD Manual for specific coverage language. http://www.cms.hhs.fov/manuals/103_cov_determ/ncd103c1_part4.pdf 2. Non-covered nationally based on evidence of harm or no benefit 3. Non-covered nationally based on lace of evidence sufficient to establish either a benefit or harm or no prior decision addressing this cancer. Now termed “coverage under protocol”. *Monitoring = monitoring response to treatment when a change in therapy is anticipated. CMS announced expanding this NCA to also address a potentially different process for determining when a PET scan is reasonably and necessary for all cancers that are currently non-covered. We welcomed public comment suggesting how CMS might do this. Before coverage of FDG PET for cancer can be extended widely, CMS believes additional data will need to become available to provide assurance that the current overall paucity of robust clinical evidence will not continue to impede the Medicare NCD process and thus potentially delay the coverage of beneficial services or the protection of beneficiaries from exposure to harmful or useless services. FDG PET will continue to be refined in coming years and it is important to have a means of assessing the quality of patient care over time to ensure that positive outcomes are maintained or improved. Data from prospective clinical studies can be an invaluable aid in ongoing assessment of the quality of care provided to patients. Collection of data in prospective clinical studies is needed to provide access to the information necessary to support the advancement of this technology. CMS considers acceptable any one of the following three types of prospective clinical studies:
A registry must include criteria that ensure that:
Further refinement of registry design is expected to occur based on public comments and further discussion with clinicians, methodology experts, and stakeholders. Specific hypotheses should be predefined and based upon analyses of combined data from all previous FDG PET studies. CMS strongly recommends that the sponsors and principal investigators of FDG PET clinical trials engage an independent, reputable imaging research center to pool the entire databases from their respective trials and conduct analyses to identify patient selection, scanner related issues and other research questions to more clearly define the data elements for the registry. CMS recognizes that there are methodological limitations to the type of data and information that can be derived from registries and other prospective studies that lack formal control groups. However, there is much that may be learned from well designed and complete registries of diagnostic imaging. It will be possible to evaluate patterns of use of PET imaging and other imaging modalities in the context of specific disease characteristics and treatment choices. The registry would also allow providers to do quality assurance with substantial longitudinal information about patients' test results, treatments, and outcomes. The specified quality criteria for eligible registries will ensure that these studies provide informative and useful prospective clinical data. While the evidence supporting the use of FDG PET for a number of the individual cancers addressed here would not, by itself, be sufficient to merit coverage, there are several considerations that lead CMS to consider these uses to be reasonable and necessary. First, the diagnostic performance and clinical utility of PET has been clearly documented for a number of other malignancies. Second, there is a common underlying molecular mechanism by which FDG PET provides functional information about tumors, which applies to malignancies for which the utility of PET has been shown, as well as the additional uses addressed in this decision. We therefore believe that the use of this technology for additional malignancies would be reasonable and necessary in the context of further clinical investigations. Selective use of this technology by clinicians experienced in its application to other cancers, and guided by information available through these registries, may well provide clinical benefit to patients. We would not expect this same logic to apply to other diagnostic technologies for which there had not yet been rigorous traditional diagnostic trials that document sensitivity, specificity and clinical utility. CMS will continue to review evidence on request to reconsider the classification of FDG PET for individual cancers. We are particularly interested in seeing evidence that would permit us to make a coverage or non-coverage decision, i.e. to move an FDG PET indication from coverage under a registry or clinical trial to coverage or non-coverage based on definitive evidence of benefit, no benefit, or harm. If adequate new evidence is available, the decision may be changed to either "coverage based on evidence of benefit" or "non-coverage based on evidence of harm or no benefit." We strongly encourage oncology imaging communities to develop evidence-based clinical practice guidelines for the use of PET and other cancer imaging modalities in diagnosing, staging, restaging, and monitoring of cancer patients.
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