Positron Emission Tomography (FDG) for Solid Tumors

CMS NCA document | source_status=Closed | review_type=1st Recon | public_comment_open=False | document_id=CAG-00181R

CMS was asked to reconsider Section 220.6 of the National Coverage Determination (NCD) Manual to end the prospective data collection requirements across all oncologic indications of FDG PET except for monitoring response to treatment. Section 220.6 of the NCD Manual established the requirement for prospective data collection for FDG PET used in the diagnosis, staging, restaging and monitoring response to treatment for brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers, as well as for cancer indications not previously specified in Section 220.6 in its entirety. We received public input indicating that the coverage framework which required cancer-by-cancer consideration of diagnosis, staging, restaging and monitoring response to treatment should be replaced by a more omnibus framework. Thus, we broadened the scope of this review through an announcement on our website and solicited additional public comment on the use of FDG PET imaging for solid tumors so that we could transparently consider this possibility. Therefore, after receiving public comments as required by § 1862(l) of the Social Security Act (the ACT), we a revising Section 220.6 of the Medicare NCD Manual to reflect a new framework for most solid tumor oncologic indications and for myeloma. This decision replaces sections 220.6.2 (FDG PET for lung cancer); 220.6.3 (FDG PET for esophageal cancer); 220.6.4 FDG PET for colorectal cancer): 220.6.5 (FDG PET for lymphoma); 220.6.6 (FDG PET for melanoma); 220.6.7 (FDG PET for head and neck cancers non-CNS/thyroid); 220.6.10 (FDG PET for breast cancer); 220.6.11 (FDG PET for thyroid cancer); 220.6.12 (FDG PET for soft tissue sarcoma); 220.6.14 (FDG PET for brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers), and 220.6.15 (FDG PET for all other cancer indications) of the NCD Manual with a single section that outlines coverage of PET scans for oncologic conditions. Section 220.6, a general section on PET scanning, will be modified as required by this decision. Coverage determinations in Sections 220.6.1 (PET for perfusion of the heart); 220.6.8 (FDG PET for myocardial viability); 220.6.9 (FDG PET for refractory seizures); 220.6.13 (FDG PET for dementia and neurodegenerative diseases), and 220.6.16 (FDG PET for infection and inflammation) describe coverage of PET imaging for non-oncologic conditions and will not be modified. 1. Framework 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 antitumor treatment strategy from other uses related to guiding subsequent antitumor treatment strategies after the completion of initial treatment. We are making this change for all NCDs that address coverage of FDG PET for the specific oncologic conditions addressed in this decision. 2. Initial Antitumor Treatment Strategy CMS has determined that the evidence is adequate to determine that the results of FDG PET imaging are useful in determining the appropriate initial treatment strategy for beneficiaries with suspected solid tumors and myeloma and improve health outcomes and thus are reasonable and necessary under §1862(a)(1)(A) of the Social Security Act. Therefore, CMS will cover only 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. As exceptions to the initial treatment strategy section above: a. CMS has reviewed evidence on the use of FDG PET imaging to determine initial antitumor treatment in patients with adenocarcinoma of the prostate. CMS has determined that the available evidence does not demonstrate that FDG PET imaging improves physician decision making in the determination of initial anti-tumor treatment strategy in Medicare beneficiaries who have adenocarcinoma of the prostate, does not improve health outcomes and is thus not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act. Therefore, FDG PET is nationally noncovered for this indication of this tumor type. b. CMS received no new evidence demonstrating a change was warranted with respect to the use of FDG PET imaging to determine initial antitumor treatment in breast cancer; thus CMS is not making any change to the current coverage policy for FDG PET in breast cancer. We continue to cover FDG PET imaging for the initial treatment strategy for male and female breast cancer only when used in staging distant metastasis. FDG PET imaging for diagnosis and initial staging of axillary nodes will remain noncovered. c. CMS received no new evidence demonstrating a change was warranted with respect to use of FDG PET imaging of regional lymph nodes in melanoma; thus we are not changing the current NCD for FDG PET in melanoma. CMS will continue noncoverage of FDG PET for the evaluation of regional lymph nodes in melanoma. Other uses to determine initial treatment strategy remain covered. d. CMS received no new evidence demonstrating a change was warranted with respect to use of FDG PET imaging in the initial treatment strategy for cervical cancer. We continue to cover FDG PET imaging 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. All other uses of FDG PET for the initial treatment strategy for beneficiaries diagnosed with cervical cancer will continue to only be covered as research under §1862(a)(1)(E) of the Act through Coverage with Evidence Development (CED) as outlined immediately below and in Section 3. Therefore, we will cover one initial FDG PET study for newly diagnosed cervical cancer when not used as an adjunct test for the detection of pre-treatment metastases following conventional imaging that is negative for extra-pelvic metastasis only when the beneficiary’s treating physician determines that the FDG PET study is needed to inform the initial antitumor treatment strategy and the beneficiary is enrolled in, and the FDG PET provider is participating in, the following type of prospective clinical study: An FDG PET clinical study that is designed to collect additional information at the time of the scan to assist in patient management. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and providers accurately report data on all enrolled patients not included in other qualifying trials through adequate auditing mechanisms; and all patient confidentiality, privacy, and other Federal laws must be followed. The clinical studies for which we will provide coverage must answer one or more of the following questions: Prospectively, in Medicare beneficiaries with newly diagnosed cervical cancer who have not been found following conventional imaging to be negative for extra-pelvic metastases and whose treating physician determines that the FDG PET study is needed to inform the initial antitumor treatment strategy, does the addition of FDG PET imaging lead to: A change in the likelihood of appropriate referrals for palliative care; Improved quality of life; or Improved survival? The study must adhere to the standards of scientific integrity and relevance to the Medicare population as described in part 3, items a through m, below 3. Subsequent Antitumor Treatment Strategy CMS reviewed evidence on the use of FDG PET in the subsequent treatment strategy for patients with tumor types other than breast, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung and thyroid. For tumor types other than breast, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid, CMS has determined 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 or improves health outcomes in Medicare beneficiaries and thus is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act. However, CMS has determined that the available evidence is sufficient to determine that 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 may be covered as research under §1862(a)(1)(E) of the Act through Coverage with Evidence Development (CED). Therefore, we will cover a subsequent FDG PET study for tumor types other than breast, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung and thyroid when the beneficiary’s treating physician determines that the FDG PET study is needed to inform the subsequent antitumor treatment strategy and the beneficiary is enrolled in, and the FDG PET provider is participating in, the following type of prospective clinical study: An FDG PET clinical study that is designed to collect additional information at the time of the scan to assist in patient management. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements a