Re: Comments on Proposed Decision Memorandum (CAG-00065R2) Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer

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1 1300 North 17 th Street Suite 900 Arlington, Virginia Tel: Fax: October 15, 2015 Tamara Syrek Jensen, Esq. Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD Re: Comments on Proposed Decision Memorandum (CAG-00065R2) Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer Dear Director Syrek Jensen: The Medical Imaging & Technology Alliance (MITA) appreciates this opportunity to submit comments to express its serious concerns with the referenced proposed decision memorandum on the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) Section B. 1 MITA contends that the published registry and other evidence submitted by the National Oncologic PET Registry (NOPR) Working Group in its reconsideration request for this coverage with evidence development (CED) decision is more than sufficient. It clearly shows the important benefits of NaF-18 positron emission tomography (NaF PET) scans in managing Medicare beneficiaries with bone metastases, and to support coverage without the data collection prerequisite. MITA therefore believes CMS should not finalize its proposed decision and instead: Remove the requirement for prospective data collection for coverage of NaF PET for oncologic indications; and Delegate to the local Medicare Administrative Contractors (MACs) the determination of coverage for non-oncologic indications. This approach would be similar to the one taken by CMS in its recent reconsideration of the CED for fluorodeoxyglucose positron emission tomography (FDG PET) for oncologic indications. 2 1 See Proposed Decision Memorandum on NaF-18 PET to Identify Bone Metastasis of Cancer (Sept. 16, 2015), available at 2 See Decision Memorandum on FDG PET for Solid Tumors (June 11, 2013), available at

2 If CMS declines to remove the data requirements and extend coverage an outcome we would have difficulty understanding we urge the agency to continue the CED until such time as the additional evidence sought by CMS can be reviewed and submitted for publication. Whereas CMS suggests a 12- month period would be sufficient to allow a confirmatory analysis of changes in patient management, MITA believes the continuation of the current CED for a more realistic time period of no fewer than eighteen months be applied. Only in this way can appropriate beneficiary access to an important diagnostic tool be preserved. About MITA MITA is the leading industry association representing medical imaging, radiation therapy, and radiopharmaceutical manufacturers. We have a long-standing and documented history of supporting appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases including oncology, neurology and cardiology applications of PET imaging and most recently low-dose CT for lung cancer screening. Because the proposed decision, if finalized, would eliminate an appropriate use for appropriate patients, MITA members strongly urge CMS to revisit the submitted data along with any additional data, and not finalize its proposed decision. MITA Comments I. EVIDENCE ON NAF-18 PET SCANS TO IDENTIFY BONE METASTASIS OF CANCER MEETS THE MEDICARE REASONABLE AND NECESSARY UNDER 1862(A)(1)(A) A. Improved Patient Management Section 1862(a)(1)(A) of the Social Security Act articulates the standard for withholding coverage if a diagnostic test is not reasonable and necessary to diagnose... an illness or injury. The proposed decision memo concludes that the appropriate measure of whether NaF PET is reasonable and necessary for purposes of meeting the 1862(a)(1)(A) standard is whether it affects health outcomes through changes in disease management brought about by physician actions taken in response to test results. 3 The proposed decision memo goes on to state that [s]uch actions may include decisions to treat or withhold treatment, to choose one treatment modality over another, or to choose a different dose or duration of the treatment. 4 We believe this is precisely what the NOPR data show. The current CED for NaF-18 Positron Emission Tomography (NaF PET) was developed to inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after completion of the initial treatment. 5 In the proposed decision memo, CMS states that to evaluate whether continued collection was needed, the agency evaluated the presented data and other published evidence for evidence demonstrating how the treating physician uses the result of a NaF-18 PET imaging test for cancer metastasis to bone in whom bone metastases are strongly suspected based on clinical symptoms or 3 CMS derives this standard from its regulation at 42 C.F.R (a), which refers to the requirement that the ordering physician must be the treating physician and must use the results in managing the beneficiary s specific condition. This regulation, therefore, defines only whether a particular diagnostic test should be covered for a particular individual whose physician orders the test (that is, it must be the physician actually caring for the patient and the test results must in fact be used by this physician). Although MITA does not agree that this is the appropriate source for deriving the standard for evaluating evidence for an NCD, we accept the standard CMS identifies that a diagnostic test should provide information that has the potential to influence the course of treatment. 4 CMS also observes in its proposed decision memorandum that [a]s a diagnostic test, NaF-18 PET would not be expected to directly change health outcomes. MITA agrees. 5 Medicare National Coverage Determinations Manual (CMS Pub ), B. 2

3 the results of other diagnostic studies. 6 The published studies on the NOPR data address the treating physicians uses of the diagnostic information in disease management. Since its inception in 2011, the NOPR NaF PET Registry has collected data for over 27,000 patients at 1,000 different PET facilities nationwide. Peer-reviewed published studies address the registry data, which include comparisons of management plans before and after NaF PET were performed on patients receiving systemic therapy for metastatic cancer. 7,8,9 This included evaluations of options to treat or withhold treatment or to choose a different dose or duration of treatment by continuing, modifying, switching or stopping all therapy. One published article reported on the analysis set of 2,217 of the patients 65 years or older receiving systemic therapy, such as chemotherapy or immunotherapy. The study s 2,839 scans had an overall post-naf PET change in intended management of 40% (42% for prostate, 39% for breast and 35% for all other cancers). Not only were the treating physicians able to use the information to plan a continuation of current therapy, a switching of therapy, modification of doses or schedule and stopping all therapy, but additionally, the referring physician judged the post-pet prognosis to be better, worse or unchanged from the pre-pet prognosis. 10 MITA believes the published NOPR data provide evidence that CMS seeks on the changes in management due to test findings. Nonetheless, CMS has rejected this data and requested confirmatory analysis, finding that the data provided by NOPR and others only reported on intended management changes, but did not confirm that actual change in management occurred. This standard is inconsistent with CMS s articulated standard for reconsidering the CED for Fluorodeoxyglucose (FDG) PET for solid tumors. There, CMS was presented with similar evidence that the FDG PET had a significant effect on the intended treatment of various solid tumors, but nonetheless concluded that the information was sufficient to support[ ] the use of FDG PET as reasonable and necessary in the management of those tumors. For example, CMS found that the FDG PET had a larger effect on intended treatment for those with primary brain tumors than those in the overall registry population, and found this evidence sufficient to conclude the use of the FDG PET as reasonable and necessary for the management of recurrent primary brain tumors. Similarly, CMS found that physicians managing treatment of patients with prostate cancer would change their intended therapy in about 40% of instances after use of the FDG PET. MITA therefore requests that CMS similarly end CED for NaF-18 PET and cover the NaF-18 PET under 1862(a)(1)(A). B. Identifies Bone Metastasis of Cancer More Precisely than Alternative Tests Physicians participating in the NOPR study indicate that without the NaF PET, other interventions would be used. Indeed, these tests have some clinical disadvantages, yet are covered without the barrier of a CED. The clinical data for prostate cancer cases show that the NaF technology may be more advantageous than alternative bone scanning (using Tc-99 diphophonates) because of its superior image 6 Proposed Decision at 3. 7 Hillner BE, et al. 18F-Fluoride PET Used for Treatment Monitoring of Systemic Cancer Therapy: Results from the National Oncologic PET Registry. J Nucl Med 2015, 56: Hillner BE, et al. Impact of 18F-Fluoride PET on Intended Management of Patients with Cancers Other Than Prostate Cancer: Results from the National Oncologic PET Registry. J Nucl Med 201; 55: Hillner BE et al. Impact of 18F-fluoride PET in Patients with Known Prostate Cancer: Initial Results from the National Oncologic PET Registry. J Nucl Med 2014; 55: See Hillner BE, et al., supra, footnote 7 at pp See also id. at 227 (The NOPR data results suggest that NaF PET leads to alterations in planned treatment in a substantial fraction of patients with osseous metastatic disease. ) 3

4 quality, and because it emits a lower radiation dose. 11 NaF PET has been shown to provide higher sensitivity and specificity than bone scintigraphy for the detection of osseous metastases in men with prostate cancer. 12 In addition to these advantages, Medicare beneficiaries across the country now are able to access this important technology because the infrastructure of cyclotrons and PET scanners is sufficient to reach all areas of the country. II. MITA URGES CMS TO CONTINUE CED COVERAGE DURING ANY FURTHER DATA GATHERING AND REVIEWS CMS covers NaF PET scans to identify bone metastasis of cancer when the service is performed through the CMS-approved registry, with a CMS-approved protocol. Over 1000 facilities have participated so far in the NaF PET study. CMS now requests additional analysis to answer the following question: Does the addition of NaF-18 PET imaging lead to: a change in patient management to more appropriate palliative care; a change in patient management to more appropriate curative care; improved quality of life; or improved survival? To allow confirmatory evidence to be performed, CMS proposes to continue the requirement for CED under Section 1862(a)(1)(E) for 12 months after CMS s final decision on this reconsideration. To the extent CMS s final decision does not continue coverage for NaF PET, MITA has serious concerns that 12 months will provide insufficient time for collection, analysis and publication of confirmatory data requested by CMS. A minimum of 18 months from the final decision is needed to obtain the necessary data, draft the requisite analysis, submit for publication, and complete the new reconsideration process. Moreover, we understand that conducting such a study will depend to a large degree on the ability to obtain expedited access to the requisite Medicare claims data. This would most likely lead to a gap in coverage for Medicare beneficiaries with devastating diagnoses. MITA therefore encourages extension of the CED for a minimum of 18 months from the date the final decision. Moreover, this extension is consistent with CMS s CED guidance. CMS s most recent CED Guidance document notes that a CED cycle is only considered completed when CMS completes a reconsideration of the CED coverage decision, and removes the requirement for study participation as a condition of coverage. Because CMS has requested further confirmatory analysis, and because such analysis will require further data gathering through extended study participation, CMS may extend the CED for longer than 12 months. MITA encourages and supports continuing the current CED so as to avoid a coverage gap for Medicare beneficiaries. CONCLUSION MITA has and continues to support the NOPR Working Group s efforts to end the data collection requirements under CED for oncologic indications using NaF PET. We believe the clinical evidence more than adequately shows the benefits of patient management with NaF PET. For the reasons stated, we therefore urge CMS to re-evaluate the evidence and revise the current CED to extend coverage for initial and subsequent imaging for oncologic indications. We also support the reconsideration request to 11 Jadvar H, Molecular Imaging of Prostate Cancer with PET. J Nucl Med 2013;54: Id. 4

5 allow Medicare Administrative Contractor discretion for non-oncologic indications to evaluate benign bone disease using NaF PET imaging. This would be consistent with the approach taken by CMS for FDG PET. To the extent the agency declines to remove the CED data requirements, we urge CMS to continue coverage under the CED until such time as additional evidence can be collected and reviewed, and the third reconsideration process can be completed, a period of no fewer than eighteen months. * * * * MITA would be pleased to answer any questions you might have about these comments or if we can be of further assistance. Please do not hesitate to contact me at (703) Sincerely, Terri Wilson, MBA, BS, CNMT Director, Molecular Imaging & PET, MITA 5