Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers

Original Letter Sent to CMS

2 December 2004

The Honorable Mark McClellan
Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
G. Hubert Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20201

Re: Draft Decision Memorandum for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N)

Dear Administrator McClellan:

We are writing to comment on one aspect of the above-named Draft Decision Memorandum issued by the Centers for Medicare and Medicaid Services on 1 November 2004. Specifically, the document states the following: "For cervical cancer, CMS considers the evidence adequate to conclude that FDG PET improves net health outcomes in the detection of pre-treatment metastases in newly diagnosed cervical cancer subsequent to negative conventional imaging and is therefore, reasonable and necessary for this indication. We will therefore, issue a positive coverage determination." The use of PET for other indications in cervical cancer would only be covered if performed as part of an approved clinical trial as outlined in the DDM.

We believe this proposed coverage decision to be flawed for two principal reasons.

First, it is illogical to reserve the use of PET for initial staging of patients with cervical cancer to those with negative conventional imaging. For one thing, the definition of "negative conventional imaging" is ambiguous. Would a CT study, for example, be considered “positive” if it showed only uterine cervical enlargement consistent with the known primary tumor detected on physical examination, or if showed enlargement of pelvic lymph nodes, but not of para-aortic lymph nodes? The first definition would preclude the use of PET for the detection of abnormal pelvic lymph nodes in many patients (found three times more often by PET than by CT) and the second would preclude the detection of abnormal para-aortic lymph nodes (also found three times more often by PET than by CT). Furthermore, both definitions, or a third definition namely that a CT study would be considered “positive” only if it showed enlarged para-aortic lymph nodes, would preclude the detection of clinically occult supraclavicular nodal metastasis (which we have found to be a grave prognostic sign, present in nearly 7% of our patients presenting for chemoradiation therapy of newly diagnosed cervical cancer). Since the most commonly employed conventional imaging performed for initial staging of cervical cancer is CT of the abdomen and pelvis and chest radiography, there is no opportunity to detect these otherwise occult supraclavicular nodal metastases. Additionally, relying on negative conventional imaging as the basis for performing PET ignores the fact that PET not only has greater sensitivity than CT or MRI, but also has about 20% greater specificity for detecting pelvic and para-aortic nodal metastasis. This principle, already well-established in the staging of other covered cancers, is a reflection of PET's much greater ability to discriminate nodal enlargement due to reactive hyperplasia from that due to metastasis. Cervical tumors often have significant necrotic components and thus reactive hyperplasia in regional nodes is quite common. Finally, the proposed sequencing of studies ignores the fact that an ever increasing number of PET studies performed in the United States are actually PET/CT studies. It is illogical to make most such patients undergo CT twice.

Second, it is quite unclear why CMS has chosen to ignore the substantial evidence indicating the value of PET for restaging of patients after treatment of cervical cancer. The recent registry study of Grigsby et al. [1] apparently was not included in the CMS internal technology assessment performed after the AHRQ review. The stated reason per correspondence with one of the CMS staff members is that the Grigsby study was not a "comparative study". Indeed, this study did not explicitly describe a comparison of the PET findings with those of either physical examination or conventional imaging. Progression-free survival was used as the reference standard instead. The vast majority of these patients did not undergo conventional imaging as part of their post-treatment assessment; this is not standard practice and is rarely helpful. CT nearly always shows partial response in the primary tumor and regional nodes early after chemoradiation therapy, and is insensitive for detecting residual disease. Also well known is how difficult it is to assess for residual or recurrent disease by physical examination, cytopathology or biopsy during the first few months after chemoradiation. Accordingly, the robust risk stratification possible with the use of PET in these patients clearly represents an improvement over previous approaches. Several other recent studies (employing a variety of reference standards) also show the improved detection of residual or recurrent disease by PET [2-8]. The obvious goal of such restaging is to detect those patients with localized residual or recurrent disease who are candidates for salvage therapy. This is based on the logical assumption, now shown by the study of Chang et al. [7], Chou et al. [9], and Singh et al. [10], that long-term-survival after salvage therapy is more likely in asymptomatic patients found to have localized recurrent disease by imaging, rather than in those with symptomatic, clinically evident recurrence.

Accordingly, we strongly recommend that CMS reconsider its proposed decision and provide unrestricted coverage of FDG-PET for initial staging and for restaging of cervical cancer, as it has done for most of the other common cancers approved to date.

Please let us know if we can provide additional information to assist CMS with its further assessment of this issue.

Sincerely yours,

David G. Mutch, M.D.
Ira C. and Judith Gall Professor of Obstetrics and Gynecology
Chief, Division of Gynecologic Oncology

Janet S. Rader, M.D.
Professor of Obstetrics and Gynecology
Associate Professor of Genetics

References

1. Grigsby PW, Siegel BA, Dehdashti F, Rader J, Zoberi I. Posttherapy [18F] fluorodeoxyglucose positron emission tomography in carcinoma of the cervix: response and outcome. J Clin Oncol 2004; 22:2167-71.

2. Havrilesky LJ, Wong TZ, Secord AA, Berchuck A, Clarke-Pearson DL, Jones EL. The role of PET scanning in the detection of recurrent cervical cancer. Gynecol Oncol 2003; 90:186-90.

3. Yen TC, Ng KK, Ma SY, et al. Value of dual-phase 2-fluoro-2-deoxy-d-glucose positron emission tomography in cervical cancer. J Clin Oncol 2003; 21:3651-8.

4. Unger JB, Ivy JJ, Connor P, et al. Detection of recurrent cervical cancer by whole-body FDG PET scan in asymptomatic and symptomatic women. Gynecol Oncol 2004; 94:212-6.

5. Chang WC, Hung YC, Lin CC, Shen YY, Kao CH. Usefulness of FDG-PET to detect recurrent cervical cancer based on asymptomatically elevated tumor marker serum levels—a preliminary report. Cancer Invest 2004; 22:180-4.

6. Lai CH, Huang KG, See LC, et al.. Restaging of recurrent cervical carcinoma with dual-phase [18F]fluoro-2-deoxy-D-glucose positron emission tomography. Cancer 2004; 100:544-52.

7. Chang TC, Law KS, Hong JH, et al. Positron emission tomography for unexplained elevation of serum squamous cell carcinoma antigen levels during follow-up for patients with cervical malignancies: a phase II study. Cancer 2004; 101:164-71.

8. Wong TZ, Jones EL, Coleman RE. Positron emission tomography with 2-deoxy-2-[(18)F]fluoro-D-glucose for evaluating local and distant disease in patients with cervical cancer. Mol Imaging Biol 2004; 6:55-62.

9. Chou HH, Wang CC, Lai CH, et al., Isolated paraaortic lymph node recurrence after definitive irradiation for cervical carcinoma. Int J Radiat Oncol Biol Phys 2001; 51:442-8.

10. Singh AK, Grigsby PW, Rader JS, Mutch DG, Powell MA. Cervix carcinoma, concurrent chemoradiation, and salvage of isolated para-aortic lymph node recurrences. Int J Radiat Oncol Biol Phys, in press.

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The Alliance of Dedicated Cancer Centers
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
City of Hope National Medical Center
Dana-Farber Cancer Institute
Fox Chase Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Roswell Park Cancer Institute
Seattle Cancer Care Alliance
Sylvester Comprehensive Cancer Center
December 1, 2004
By Electronic Mail

Stuart Caplan
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room C1-12-06
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Comments on CMS Draft Decision Memo: PET (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N)

Dear Mr. Caplan:

On behalf of the Alliance of Dedicated Cancer Centers, an alliance of ten nationally recognized institutions focusing exclusively on the care of cancer patients, I am writing to comment on the recently issued Draft Decision Memo that would expand coverage of PET (FDG). The Cancer Centers, individually listed above, appreciate the opportunity to submit these comments.

DISCUSSION

We describe below a number of concerns about CMS’s proposal for coverage of PET (FDG) for the listed cancers. In general, the Centers support CMS’s efforts to establish a national registry program for measuring the accuracy and utility of PET (FDG) for cancer patients. The Centers are concerned, however, that CMS’s proposal may result in reduced patient access to this important diagnostic tool. To help avoid this outcome, we provide several recommendations that we believe will help CMS achieve its goals, while allowing patients access to effective, state-of-the-art cancer care.

First, it is critical that the registry program be based on a consensus model, created with input from nuclear medicine experts, as well as agency experts, and be designed specifically for clinical oncology scenarios. The Centers direct your attention to a recent article in the Journal of Clinical Oncology as one possible model. See Bruce Hilner, et al., Clinical Decisions Associated With Positron Emission Tomography in a Prospective Cohort of Patients With Suspected or Known Cancer at One United States Center, 22 J. Clinical Oncology 4147 (Oct. 15, 2004). We believe including clinical trial PET (FDG) scan data in such a registry program would be reasonable. Additionally, it is crucial that participation in a national registry program not limit the ability of a facility to establish local or institutional registries or clinical trials.

Second, we wish to clarify that the Draft Decision Memo requirement that patients be offered enrollment in a national registry program (or approved clinical trial) does not mean that patients must enroll in such a registry as a prerequisite for receiving Medicare coverage of their PET (FDG) scan. Such a clarification would help ensure that CMS is able to obtain the necessary data to evaluate PET (FDG) effectiveness without reducing individual patient access to this valuable technology.

Third, the Centers oppose CMS’s policy of making specific coverage determinations based on the primary type of cancer being diagnosed and treated. In many clinical scenarios, PET (FDG) is a critical study that is performed not only for an initial diagnosis, but also for the establishment of critical baseline information to evaluate prognoses and outcomes. In addition, the decision to perform PET (FDG) scanning often is made by members of a multidisciplinary team of cancer experts, not just nuclear medicine physicians. Consequently, we believe that a more appropriate method to determine Medicare coverage would be to link to specific diagnostic questions to be answered by these multiple specialists at the time of the referral for testing. This model would eliminate the existing focus on specific primary tumor type. These screening parameters could then be an integral element of the data collected by the registry.

The Centers agree with CMS that an effort should be made to limit use of PET (FDG) in situations where it may not be clinically useful or appropriate. The Centers have long been at the forefront of basic science experiments, translational studies, and clinical trials regarding the use of PET (FDG) for many cancer types, but we are concerned that tumor specific coverage will limit the utility of this technology and impede clinical progress. CMS’s proposal will add valuable knowledge to the field, but should be carefully structured so that participating imaging centers can continue to make appropriate decisions based on valid screening and follow-up tools.

CONCLUSION

Thank you for your willingness to consider our views. We are hopeful that CMS will address the concerns described above and make the necessary adjustments to the Draft Decision Memo. If you have any questions or require additional information, please contact Dr. James B. Dougherty, of the Arcus Group, LLC, at (212) 785-2236.

Sincerely yours,

James S. Quirk
Senior Vice President
Memorial Sloan-Kettering Cancer Center
**Please also see original letter submitted as attachment. Thank you.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

Please, treat breast cancer patients like other cancer patients.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET).

I am pleased by the efforts of the Centers for Medicare & Medicaid Services’ (CMS) Coverage and Analysis Group over the past several years in reviewing PET scans technology. PET scans are a breakthrough technology and have deserved and received considerable attention from CMS. As such, I am supportive of the draft National Coverage Decision (NCD) coverage policy that would expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET. This proposal is clearly a step in the right direction.

However, I am gravely disappointed by the limited coverage decision that CMS has proposed. A quick review of the comments received by CMS from researchers and clinicians provides ample evidence for a positive coverage decision by CMS for each of these cancers, especially ovarian. There have been many peer review publications that present evidence on the benefits of PET in the management of patients with cancer. As CMS reviews the comments, I trust that you will be persuaded by the substantial body of evidence and that the final NCD will include a positive coverage decision based on the submitted evidence.

Although I am sure that CMS is aware of the grim statistics regarding ovarian cancer, I would like to emphasize that ovarian cancer remains the deadliest of the gynecological cancers. As our nation’s population ages, all signs point to an increase in incidence, especially if detection remains so difficult. PET scans appear to help solve the problem of detection for some with ovarian cancer.

I look forward to CMS expanding the coverage of PET scans for Medicare beneficiaries with cancer. If CMS takes the lead on this important issue, no doubt private health insurers will follow. This would be an important and significant step in battling this deadly cancer.

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The National Coalition for Cancer Survivorship (NCCS), representing survivors of all forms of cancer, commends the Centers for Medicare & Medicaid Services (CMS) for its proposed plan for coverage of PET scans for diagnosis and staging of several cancers. NCCS supports the efforts of CMS to ensure coverage for PET scans while at the same time encouraging clinical trials and a registry that may yield valuable information about the effectiveness of PET scans in cancer diagnosis.

By ensuring coverage of PET scans for those with cervical, brain, ovarian, pancreatic and small cell lung cancers, the CMS decision immediately removes a barrier to high-quality care. Investing in data collection about PET scan use in these populations may equip CMS to ascertain the effectiveness of PET technology in these indications. We appreciate that CMS has asked for advice about the appropriate entities to analyze the data from trials and the registry, and we encourage the agency to take care in determining the parties that should have access to these data and be charged with analysis of them.

Because this proposal represents an innovative approach to coverage of a cancer diagnostic, its implementation may be challenging. We encourage CMS to work closely with the professional organizations and patient advocacy groups whose members will be using and benefiting from this technology as part of cancer care to guarantee that this coverage plan moves forward without delay.

The draft decision memo includes a non-coverage decision for the use of PET in testicular cancer. We note that the authors of the Agency for Healthcare Research and Quality (AHRQ) technology assessment (TA) conceded that the literature suggests a possible role for PET scan in staging testicular cancer but that the studies have serious limitations and additional research is necessary to confirm the utility of PET in testicular cancer. NCCS recommends that CMS, instead of issuing a non-coverage decision for PET in testicular cancer, allow coverage of PET scans for testicular cancer in the context of clinical trials. These studies would be responsible means of obtaining the information that the TA authors indicate is needed with regard to PET in testicular cancer.

NCCS appreciates the opportunity to comment on the draft decision memo and looks forward to continued cooperation with CMS to improve the quality of cancer care.

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I am writing on behalf of the North American Brain Tumor Coalition (NABTC) in support of the Draft Decision Memo for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancer (CAG-00181N). The NABTC is a network of brain tumor organizations dedicated to improving the treatments for brain tumors and ensuring that brain tumor patients have access to quality health care. We commend the Centers for Medicare & Medicaid Services (CMS) for developing the coverage policy outlined in the Draft Decision Memo, which will contribute to quality health care for brain tumor patients.

We commend CMS for expanding coverage of PET scans for brain cancer and several other forms of cancer and establishing a means to collect data on the use of PET in these cancers. In fact, we believe that the efficient and comprehensive collection of data about the use of PET scans depends significantly upon availability of Medicare reimbursement. Therefore, the CMS approach is the sensible one.

NABTC appreciates the opportunity to comment on the CMS decision on PET scans for use in Medicare patients with brain tumors.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

I look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

Cynthia Gail Leichman, MD
Jedidiah Monson, MD, MPH
Lawrence Leiderman, MD
Peter Greenberg, MD
Elber S.Camacho, MD

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On behalf of the Alliance of Dedicated Cancer Centers, an alliance of ten nationally recognized institutions focusing exclusively on the care of cancer patients, I am writing to comment on the recently issued Draft Decision Memo that would expand coverage of PET (FDG). The Cancer Centers, individually listed above, appreciate the opportunity to submit these comments.

DISCUSSION

We describe below a number of concerns about CMS's proposal for coverage of PET (FDG) for the listed cancers. In general, the Centers support CMS's efforts to establish a national registry program for measuring the accuracy and utility of PET (FDG) for cancer patients. The Centers are concerned, however, that CMS's proposal may result in reduced patient access to this important diagnostic tool. To help avoid this outcome, we provide several recommendations that we believe will help CMS achieve its goals, while allowing patients access to effective, state-of-the-art cancer care.

First, it is critical that the registry program be based on a consensus model, created with input from nuclear medicine experts, as well as agency experts, and be designed specifically for clinical oncology scenarios. The Centers direct your attention to a recent article in the Journal of Clinical Oncology as one possible model. See Bruce Hilner, et al., Clinical Decisions Associated With Positron Emission Tomography in a Prospective Cohort of Patients With Suspected or Known Cancer at One United States Center, 22 J. Clinical Oncology 4147 (Oct. 15, 2004). We believe including clinical trial PET (FDG) scan data in such a registry program would be reasonable. Additionally, it is crucial that participation in a national registry program not limit the ability of a facility to establish local or institutional registries or clinical trials.

Second, we wish to clarify that the Draft Decision Memo requirement that patients be offered enrollment in a national registry program (or approved clinical trial) does not mean that patients must enroll in such a registry as a prerequisite for receiving Medicare coverage of their PET (FDG) scan. Such a clarification would help ensure that CMS is able to obtain the necessary data to evaluate PET (FDG) effectiveness without reducing individual patient access to this valuable technology.

Third, the Centers oppose CMSs policy of making specific coverage determinations based on the primary type of cancer being diagnosed and treated. In many clinical scenarios, PET (FDG) is a critical study that is performed not only for an initial diagnosis, but also for the establishment of critical baseline information to evaluate prognoses and outcomes. In addition, the decision to perform PET (FDG) scanning often is made by members of a multidisciplinary team of cancer experts, not just nuclear medicine physicians. Consequently, we believe that a more appropriate method to determine Medicare coverage would be to link to specific diagnostic questions to be answered by these multiple specialists at the time of the referral for testing. This model would eliminate the existing focus on specific primary tumor type. These screening parameters could then be an integral element of the data collected by the registry.

The Centers agree with CMS that an effort should be made to limit use of PET (FDG) in situations where it may not be clinically useful or appropriate. The Centers have long been at the forefront of basic science experiments, translational studies, and clinical trials regarding the use of PET (FDG) for many cancer types, but we are concerned that tumor specific coverage will limit the utility of this technology and impede clinical progress. CMS's proposal will add valuable knowledge to the field, but should be carefully structured so that participating imaging centers can continue to make appropriate decisions based on valid screening and follow-up tools.

CONCLUSION

Thank you for your willingness to consider our views. We are hopeful that CMS will address the concerns described above and make the necessary adjustments to the Draft Decision Memo.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

I look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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The undersigned organizations. representing cancer patients, providers, and researchers, are writing to express their support for the draft decision memo for coverage of PET scans as a diagnostic tool for several cancers. We applaud the Centers for Medicare & Medicaid Services (CMS) plan to cover PET scans in brain, ovarian, pancreatic, and small cell lung cancers while at the same time collecting data that may establish the benefits of the technology in these cancers.

We note that CMS concluded that the evidence was sufficient to support coverage of PET for cervical cancer diagnosis and staging without requiring enrollment in a trial or registry, while the agency issued a non-coverage decision for use of PET in testicular cancer. Because the CMS-requested technology assessment concluded there is some evidence of the utility of PET in testicular cancer and in light of the most recent recommendations from the National Comprehensive Cancer Network that PET scans be used in cases of recurrent or residual testicular cancer, we would encourage the agency, instead of establishing a non-coverage policy, to cover the technology for testicular cancer if patients are enrolled in a high-quality clinical trial. This approach is responsive to the conclusion of the technology assessment that more studies are necessary to establish the effectiveness of PET in testicular cancer.

We urge CMS to clarify that coverage for PET scans will be available in the context of clinical trials for those cancers for which a non-coverage decision has not been issued. Such a policy is especially important for use of PET scan in multiple myeloma, a PET scan use which is not included in this coverage analysis but which may show promise in this orphan cancer. Coverage in clinical trials will facilitate the collection of data about the appropriate use of PET in multiple myeloma.

This innovative plan for coverage will likely encounter some implementation obstacles, and we are encouraged that CMS is consulting with the professional and research organizations whose members will be utilizing PET in cancer diagnosis and staging and analyzing the clinical trials and registry data.

We appreciate the opportunity to comment on this proposal and look forward to working with CMS on other cancer care coverage and reimbursement issues.

Sincerely,

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). I am very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Our medium-sized community hospital has show the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, and multiple myeloma in our patients. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications, and for more unusual cancers. It will be impractical to gather data on each rare tumor to prove this. For instance, PET scanning has been extremely effective in one pediatric patient with rhabdomyosarcoma in our practice. We are not likely to see another case.We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.Thank you very much for your attention to this matter.

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Re: Draft Decision Memo for Positron Emission Tomography (FDG) for Brain Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N)

Dear Dr. McClellan:

On behalf of thousands ovarian cancer survivors and their families, the Ovarian Cancer National Alliance supports, with some reservation, the CMS decision to explore the benefits of Positron Emission Tomography.

CMS should be aware that many physicians across the country have successfully used PET Scans in combination with other diagnostic procedures to diagnose recurrent ovarian cancer in individual patients for several years. While it is our hope that the proposed clinical trials quickly demonstrate the positive benefits of using PET scans to diagnose ovarian cancer and its recurrence, we urge CMS to be aware of the mounting evidence of this effective and life-sparing use and to proceed with all due speed in monitoring the trial's results.

The decision is a step in the right direction to allow all women with ovarian cancer to have access to the best diagnostic approaches possible. The Alliance looks forward to working with CMS to publicize the clinical trials to the ovarian cancer community. Sincerely,

Ginger Ackerman Smith
President
The Ovarian Cancer National Alliance

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The Society of Nuclear Medicine (SNM) representing more than 14,000 physicians, physicists, scientists, pharmacists and nuclear medicine technologists, appreciates the opportunity to comment on the November 1, 2004 draft decision memorandum for Positron Emission Tomography (FDG PET) for cervical cancer, and for expanded coverage of additional types of cancers through prospective clinical trials using a National Patient Data Registry (NPDR).

As stated previously the SNM supports expanded coverage of FDG PET. We are disappointed in the decision not to cover the F-18 FDG PET patients with ovarian carcinoma and brain tumor. While we believe there is already extensive clinical experience and literature published to date to support the use of FDG PET in tumors. We are pleased that CMS supports establishment of a national patient database. The SNM encourages CMS and the community to collect the relevant data to continue to expand and provide these valuable medical services to the Medicare population. We commend CMS for this next important action to develop a NPDR and believe that the proposed decision memorandum is a positive step forward for Medicare beneficiaries.

We encourage CMS to continue to involve key stakeholders in the design, structure, function and implementation of the registry to ensure its success. The SNM hopes that the design of the NPDR is such that the entry of patients into the registry does not introduce an administrative burden to providers. We are concerned that if this is not done, this could result in collection of an insufficient number of usable studies to provide statistically significant data. We believe simplifying the entire registry process, including coding of these studies, would be easier for both the CMS and Medicare providers.

We encourage CMS to remain open to established entities, such as the American College of Radiology Imaging Network (ACRIN) or potentially other groups for management of this NPDR. The SNM is committed to working with CMS or a CMS chosen contractor, through all steps of this process; including design, education and implementation, to insure the best possible participation and the collection of meaningful data.

Again, the SNM appreciates the opportunity to comment on this proposed draft decision memo for positron emission tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET) on behalf of Alliance Imaging, which is the largest provider of PET and PET/CT services in the United States. Alliance currently owns and operates 51 PET and PET/CT systems and, through utilization of our fixed centers and mobile fleet, provide service to over 250 facilities varying in size and service area from small rural communities to large university settings. Last year Alliance performed 40,900 scans, allowing physicians and patients to gather information not available through other imaging modalities. Alliance is committed to providing exceptional patient care and access to new technologies in partnership with hospitals and physicians across the nation.

Alliance is very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to definitively demonstrate whether a tumor is malignant or benign. PET reveals metastatic disease other imagning techniques cannot detect; it inspects all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS overtook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions of PET for canceer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinicl practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cncer indications based on all of the evidence submitted to CMS.

Please support the expenses of Medicare coverage for diagnostic imaging for all cancer types using PET scan capability. I respectfully request that the final decision include a positive coverage decision for these cancer indications. Thank you very much for your consideration.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). Trident Molecular Imaging, LLC and the three PET/CT Centers that we own and operate are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can and has eliminated unnecessary surgeries, and reduces the number of diagnostic procedures required for accurate staging.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry will allow CMS to make decisions on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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Linda Dugger is writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer. In oncology, PET is the most accurate non- invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

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November 30, 2004

Sean Tunis, MD
Chief Medical Officer
Centers for Medicare & Medicaid Services
Via e-mailstunis@cms.hhs.gov

Re: Comments on Draft Decision Memo for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N)

Dear Dr. Tunis:

I am writing to provide comments on the Draft Decision Memo referenced above on behalf of the Blue Cross and Blue Shield Association (BCBSA). BCBSA is an association of 41 independent Blue Cross and Blue Shield Plans providing health benefits to almost 92 million Americans, one in three. The BCBSA Technology Evaluation Center (TEC), co-sponsored by Kaiser-Permanente, is an AHRQ Evidence Based Practice Center.

These comments will address two elements of the Draft Decision Memo: “limited” coverage based on clinical trial or registry participation and alternatives to an indication by indication approach to coverage determinations for PET scans for cancer.

“Limited” CoverageCMS coverage decisions for the use of FDG PET in cancer are currently categorized in three ways:

• Coverage based on evidence of benefit (positive evidence)
• Non-coverage based on evidence of harm or no benefit (negative evidence), and
• Non-coverage based on lack of evidence sufficient to establish either benefit or harm.

CMS is proposing in this Draft Decision Memo to institute a new approach, “limited coverage” for indications in the third, insufficient evidence category. CMS notes that the usual level of evidence regarding diagnostic accuracy and clinical utility required to ensure patient protection and appropriate utilization is absent for this category. However, CMS believes that patient protection can be provided by requiring data collection on patients receiving FDG PET scans for indications in this category. CMS proposes to require providers to participate and patients to be offered enrollment in one of three types of prospective clinical studies in order to be eligible for this limited coverage. The three types of clinical studies are:

• A clinical trial of FDG PET that meets the requirements of the FDA category B investigational device exemption (IDE) or
• A clinical trial consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards or
• An FDG PET registry that is designed to provide additional information on the diagnostic accuracy and clinical utility of FDG PET diagnosis, staging, restaging, and/or monitoring of one or more cancers. CMS details potential criteria for eligible registries.

BCBSA commends CMS for its commitment to evidence-based decision-making and acknowledges its flexibility in supporting the development of evidence. CMS rightly observes that data from prospective clinical studies can be an invaluable aid in ongoing assessment of the quality of care provided to patients. It is also essential that these studies contribute to the determination of the clinical utility of the FDG PET indications at issue. Well designed clinical trials can meet this goal. Unfortunately, there are significant concerns about whether registries will be able to answer questions of efficacy and clinical utility. The CMS Draft Memo gives registries and trials equal weight. Providers may gravitate to the registry option and this could actually impede the completion of necessary clinical trials.

The Draft Memo provides detailed criteria defining eligible registries. If all the specified data are submitted, the registries may be useful in determining if FDG PET scans change patient management. However, determining whether the use of PET scans actually improves outcomes will require collection of outcomes data such as clinical follow-up and/or results of biopsy confirmation. Because patients in registries may not consistently have disease status verified before FDG PET results are used to influence management, it is important to note that registries are unlikely to provide reliable diagnostic performance data. CMS is calling for eligible registries to document outcomes but missing or limited data will reduce the usefulness of this information for making determinations of clinical benefit.

We have a number of questions about the new limited coverage option. Who will fund the clinical trials and registries called for? How will physician effort be compensated? The proposed limited coverage for FDG PET will provide reimbursement to the physician who performs the FDG PET study. However, the referring physician will be expected to make a significant effort, particularly for a registry, in providing the clinical background and follow-up information expected. Physicians will need to follow patients and continue submitting data on them for a long time post-scan in order to document potential changes in clinical management and relevant outcomes. What compensation or incentive will there be for referring doctors to provide this information? Will CMS support the costs of data reporting by oncologists and other treating physicians? Will CMS verify that Medicare beneficiaries are, in fact, enrolled in clinical trials or registries before paying for the scans or approving reimbursement? CMS may need to institute a prior approval mechanism to assure that the conditions of limited coverage are met and that beneficiaries understand the terms of coverage for the FDG PET scans.

The language of the Draft Memo suggests that beneficiaries will be “offered enrollment” in trials and registries. Will CMS withhold coverage if the beneficiaries decline enrollment? Does CMS intend to end “limited” coverage if subsequent data show the scans to be of no benefit? Rescinding coverage can be politically unpopular.

Finally, we have concerns about the public treasury funding trials that manufacturers should be undertaking. Broad coverage of FDG PET will increase utilization and the profits of the PET and contrast agent manufacturers. CMS notes in the Draft Memo that “collection of data in prospective clinical studies is. . . necessary to support the advancement of this technology.” Industry will reap the financial rewards from advancement of this technology and should invest in the necessary research.

The BCBSA has welcomed this chance to review the CMS proposal for limited coverage and to share our concerns about it. Given the limitations we have cited in the registry approach and given restrictions imposed by contract language, we would find it difficult to recommend a similar approach to Blue Cross and Blue Shield Plans for their privately covered members. We would be happy to discuss our concerns with you if that would be helpful.

Alternatives to an Indication by Indication Approach to Evaluating FDG PET Scans for Cancer:

We recognize that performing assessments of FDG PET scans for each cancer and each clinical indication (detection, diagnosis, staging, monitoring) is a resource-intensive process that is difficult to sustain. However, it is essential to examine clinical effectiveness in terms of effect on health outcomes for all technologies, including FDG PET. Because direct evidence of clinical effectiveness is lacking, indirect evidence must be used to support decision-making. An indication by indication approach is necessary when indirect evidence is employed.

One potential modification to a strict indication by indication approach may be considered. If there are tumors that can be grouped because, for all practical purposes:

Then, within such clearly defined groups of tumors, it may be possible to link together indirect evidence and generalize empirical evidence from some tumors within a group to support efficacy of FDG PET for all tumors in that given group. Once these clinically similar tumor groups are classified, the classifications may also be useful and generalizable for evaluating the effectiveness of other new imaging technologies for use in oncologic settings. An inventory of treatment decision algorithms for various tumors and indications would also be useful for assessing the relative effectiveness and cost-effectiveness of alternative diagnostic strategies.

This modified approach would still require considerable effort. Necessary implementation steps would include:

Generalization of data from one tumor to another would not be workable where there are considerable differences in anatomical context. For example, it is harder to distinguish a pathological hot spot on PET from the surrounding normal structures in different anatomical locations close to vasculature or metabolically active organs like the brain.

We appreciate the opportunity to comment and would be happy to discuss our concerns and suggestions, as needed.

Sincerely,
Allan M. Korn, MD, FACP
Senior Vice President and
Chief Medical Officer

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in nuclear medicine strongly support your proposal to cover PET studies in cancer patients when those studies are performed under research protocols. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

However, I am disappointed that your proposed policy excludes breast cancer patients, and I am perplexed regarding the reason(s). It has been communicated to me that one of the reasons is that Medicare during its previous review of the literature was "convinced" that there was no utility of PET scans other than in the evaluation of recurrence or the assessment of treatment in patients with breast cancer. If that is the case, I would submit that the data is not convincing at all, and we specifically need to do further research regarding the utility of PET scans in many other areas of the evaluation and assessment of patients with breast cancer. The exclusion of patients with breast cancer does not make sense and is inconsistent with the philosophy of the very policy being implemented. This policy should be modified to allow coverage for PET studies performed as part of a research protocol for patients who have breast cancer.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004 (hereafter referred to as the "November 2004 Draft Decision Memo"). My colleagues and I at Naviscan PET Systems, Inc., a developer of high-resolution PET devices, believe that the Coverage and Analysis Group is to be commended for proposing such a novel policy initiative. It provides coverage for some PET studies while at the same time helps the medical community develop additional information to inform patients, providers and third party payers about the appropriate use of this important technology. It is a great advance forward in coverage policy.

That said, we are extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. We are hopeful that this interpretation of the November 2004 Draft Decision Memo is incorrect, and the language is simply unclear. As I describe below, we believe the clinical evidence and policy considerations dictate that PET studies in breast cancer patients should qualify for coverage, just as they will for all the other cancers identified in your November 2004 Draft Decision Memo.

SPECIFIC COMMENTS AND RECOMMENDATIONS

1. The proposal to cover PET studies under a research protocol for 15 specific cancers and other unspecified cancers is a good policy and should be implemented as soon as possible.

PET provides extraordinary clinical value for many thousands of patients and clinicians each year and warrants expanded coverage. At the same time, however, we recognize the limitations of data in the medical literature. We therefore agree with your assessment in the Draft Decision Memo that “…a sufficient inference of benefit can be drawn to support limited coverage if certain safeguards for patients are provided." The proposal to provide coverage under specific research protocols would meet this stipulation and we strongly recommend that you implement the policy as soon as possible.

2. Breast cancer should not be singled out as the only cancer to be denied coverage under protocol

The November 2004 Draft Decision Memo limits the scope of coverage under research protocols by stipulating that"... previous national non-coverage determinations based on evidence of lack of benefit will remain in effect." The impact of this stipulation is revealed in the table of Appendix C1 that summarizes the policy for 16 specific cancers as well as a l7th category for "All other cancers not listed herein." In 15 of the 17 cancer categories, the cancer qualifies for some type of "Coverage Under Protocol." And because PET for solitary pulmonary nodules is already covered and does not require any additional coverage under research protocols, that leaves breast cancer as the only cancer tvpe that is denied any possibilitv of "Coverage Under Protocol."

We struggled to understand why CMS would implement a forward-thinking policy but deny breast cancer victims the same benefits as other patients, and came to the conclusion that the denial was a result of an unfortunate error in language. In the February 2002 Decision Memo for Positron Emission Tomography (FDG) for Breast Cancer (CAG-00094N, hereafter referred to as the "February 2002 Decision Memo"), assessments were made about the evidence presented for several breast-related indications. The assessments were of three types: (a) indications for which there was sufficient evidence to suggest that FDG PET was efficacious (e.g., breast cancer recurrence and monitoring response to therapy), (b) indications for which there was insufficient evidence to show that FDG PET was efficacious (e.g., applications to small, non-palpable cancers), and (c) indications for which there was minimal evidence suggesting that FDG PET was not likely to benefit patients (e.g., avoiding a biopsy).

Unfortunately, due to the specific language used in the November 2004 Draft Decision Memo, indications for which there were insufficient data at the time of the February 2002 Decision Memo to determine efficacy will be lumped together with the indications that were shown to have little benefit on the basis of minimal data. If approved as drafted, the language of the November 2004 Draft Decision Memo will significantly reduce the chances that new breast-related FDG PET indications will ever be developed, or that new data will ever be accumulated for indications that were previously assessed on the basis of minimal data.

Consider the following quotes from the February 2002 Decision Memo, which clearly indicate the need for new data about FDG PET breast applications:

I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

I look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

Less

Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

Less

Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

I am the senior mammographer and Director of New Technologies for the Lee Breast Center at the USC/Norris Comprehensive Cancer Center in Los Angeles.

PET has allowed for tremendous advances in our battle against cancer. My colleagues and I are investigating PET in the management of both local and advanced disease. Specifically, we are investigating the feasibility of PET in the determination of extent of disease within the breast.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. This implies discrimination against women and is a step backwards in finding new methods for the diagnosis and treatment of breast cancer. More than 250,000 women will be diagnosed with breast cancer in the United States this year. At highest risk are the uninsured, especially women of Spanish descent. Using PEt research protocols to accurately diagnosis and define the extent of breast disease would greatly impact decisions for breast cancer treatment and hopefully increase life expectancy while reducing future healthcare costs for women everywhere.

I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

Less

I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

Less

I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. It is totally inappropriate to have a covered benefit for all cancer patients except those with breast cancer. I implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients.

Thank you for the opportunity to comment.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

I look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

I look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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I am very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures. Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

Specifically,

1. The proposal to cover PET is a good policy and should be implemented.

2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.

3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

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On behalf of Integral Nuclear Associates, I am writing to comment on the November 1, 2004 draft national coverage decision, on the expansion of coverage for Positron Emission Tomography (PET). We strongly support the draft NCD coverage policy that would expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. This expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures. PET Scans, also provide critical information that positively impacts patient management. Additionally we have found PET invaluable in the management of these patients, by helping to direct therapy.We look forward to working with you to expand the coverage of PET Scans for Medicare beneficiaries with most cancers. Thank you, for your consideration in this matter.

Sincerely,
Edward Grace
Credentialing Manager

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Dear Administrator McClellan:

During the past two years, the University of North Carolina Hospitals has studied patients with PET (and, more recently PET/CT) for all of the CMS-approved indications for cancer and many of our patients have benefitted greatly in terms of improved management for their cancers. We have had less experience with cervical, ovarian and pancreatic cancer due to lack of adequate insurance; however, it is our impression that PET in these conditions similarly offered great help in cancer therapy management. Our experience in brain and small cell lung cancer is quite limited, but I am familiar with the literature for these cancers, showing the value of PET scanning for their evaluation. Thus, I am certainly supportive of the draft decision of 11/1/2004, which offers at least limited coverage for PET in these cancers. I am surprised that only cervical cancer received a clearly positive decision, however! I am also concerned that there is now question about continued coverage for PET in breast cancer - we have been able to favorably affect management for a significant number of breast cancer patients at UNC.

While I am consider the draft decision a step in the right direction, I feel it is too tenative a step! Other cancers such as GIST and multiple myeloma have not been considered and testicular cancer got a non-coverage decision, which is perplexing. Truly, the current CMS approach of piecemeal approval on a cancer by cancer basis is not good, as it denies the benefits of PET to so many patients now suffering from cancer. I support the idea of a National Patient Data Registry (NPDR), but would suggest that CMS make a bold move to approve PET for all currently non-approved cancers, subject to initial entry into the NPDR for collection of data regarding the usefulness of PET for each tumor type.

Sincerely yours,

William H. McCartney, MD

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Dear Administrator McClellan:

During the past two years, we have been performing PET studies and, more recently, PET/CT studies at the University of North Carolina for all of the CMS-approved indications and many of our patients have greatly benefitted from PET-induced management changes in their cancer therapy. We have had more limited experience with cervical & ovarian cancer, due to lack of adequate insurance coverage; however, PET seemed to offer similar critical information for these cancers and I am happy that they will be covered in some manner as indicated by the draft memo of November 1st. I am concerned that coverage for PET in breast cancer may be jeopardized, as we have been able to provide extremely helpful management data to patients with this disorder in the past few months. Please don't remove this option for breast cancer patients!

I must note that, while expansions of PET coverage such as those above are quite welcome, the CMS approach of approving indications in the current piecemeal fashion (cancer by cancer)is severely constraining our ability to provide the best information to our patients to help them in managing their life-threatening cancers. Further, the limitations imposed on these approvals has also made our task much more complex.

Although we have had very limited experience at UNC with PET in brain, pancreatic and small celllung cancer, I am familiar with the literature supporting these indications and strongly support their approval. Naturally, collection of additional data on all these currently non-covered cancers would be useful and we will be happy to cooperate. Other cancers not currently approved such as GIST and multiple myeloma would benefit from a simlar approach, and it is not clear to me why testicular cancer was given a non-coverage decision, rather than approval subject to further data collection.

In summary, the draft national coverage decision of November 1, 2004 is a helpful step, but is really too tenative a step. Let's move forward with a more bold approach to approve PET for all currently non-approved cancers subject initially to entry into a National Patient Data Registry, until adequate management data is available for their long-term approval.

Sincerely yours, William H. McCartney, MD

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I am writing to provide comments on the Draft Decision Memo for Positron Emission Tomography (PET), dated November 1, 2004.

My colleagues and I in the breast care, radiology and nuclear medicine communities wholeheartedly support your proposal to cover PET studies in cancer patients when performed under research protocols. PET is a valuable and proven imaging modality that provides extraordinary benefit for patients. Your new policy will help us further develop and refine the data for using PET to improve patient outcomes.

I am very concerned, however, with your proposed policy’s exclusion for breast cancer patients. Orange County has the highest incidence of breast cancer in the State of California. The number of women electing lumpectomy as their surgical procedure of choice is also very high in our community. It is not infrequent to discover post-operatively that surgical margins were not clear or that unsuspected nodes were involved. These findings dictate another trip to the surgical suite for more extensive tissue removal and presents additional surgical rish to the patient. As a qulity of life matter, the return to the OR results in a substantially increased anxiety level for both the patient and her family – no small consequence when fears are already raging. With the advent of improved high resolution PET imaging, we are extremely optimistic in our efforts to design clinical studies that will hopefully allow for more comprehensive surgical planning and elimination of the majority of these second surgeries. Elimination of patient risk, more effective and efficient utilization of high cost health care resources and improved patient experience would seem to be complelling reasons for expanding the policy’s provisions and covering initial breast cancer staging and surgical planning. Implore you to modify the policy and allow for coverage under protocol to apply to breast cancer patients. Thank you for the opportunity to comment.

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PET imaging provides unique information related to the metabolism of compounds such as FDG in the body. Anyone suffering from cancer, or worried about whether something unwanted is occurring in their bodies, would benefit from knowing what is happening within their bodies. The wonderfull thing about this imaging technique is that in the same diagnostic procedure, one learns about not just where physicians suspect there may be problems, but one sees what is going on throughout the whole body. The fear and worry about where things are going wrong can be examined using PET, and this information can provide great peace of mind. The goal is to diagnose early and thoroughly, which PET can do. People should not need to wait for a cancer to be confirmed and biopsied before using this imaging method.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET}. I am very Supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer. We recently reported in a prospective cohort that physicians changed their intended management in 61% of patients based on PET imaging results (J Clin Oncol 2004; 22:4147- 41560).

Diagnosis, staging and management of patients with cancer is complex and difficult, and unfortunately no single exam, test or imaging procedure provides all the data in every case for the physician and patient to make the most informed decision. In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Now, after extensive review, that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer.

I was extremely disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. On a personal note - referring physicians, caring for patients with cancer, cannot understand why PET imaging is not CMS-covered for these malignancies, and I am unable to provide them with a reasonable answer as, in my opinion, the literature supports the incremental benefit of PET imaging in the evaluation and management of most patients with cancer. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data. Thank you very much for your attention to this matter.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

I look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

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Thank you for the opportunity to comment on your Draft Decision Memo for Positron Emission Tomography (PET) dated November 1, 2004. I am extremely concerned and disappointed that the proposed policy appears to effectively exclude PET studies in breast cancer patients from qualifying for coverage as part of research studies. I am hopeful that this interpretation is incorrect and the language is simply unclear.

1. The proposal to cover PET is a good policy and should be implemented.
2. Breast cancer SHOULD NOT be singled out as the only cancer to be denied coverage under protocol.
3. CMS should add that breast cancer patients will qualify for coverage under protocol.

Please, treat breast cancer patients like other cancer patients.

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Dear Administrator McClellan:

Thank you once again for the opportunity to comment on the draft decision memo dated November 1, 2004, pertaining to expanded coverage of positron emission tomography (PET) for cancer care. The AMI, an association of physicians, providers and researchers using nuclear medicine to advance treatment of patients with cancer, appreciates the efforts of the CMS over the past several years in reviewing the breakthrough PET technology as it applies to this disease. Over the past two years, AMI has been working with CMS to expand PET coverage for leading cancer indications, eight of which are now currently covered. Non-coverage by CMS for the remaining indications prevents carriers from covering cases where a PET scan can benefit a patient.

Although AMI applauds CMS’ recent decision to extend coverage of PET to most of the remaining non-covered cancers, we are extremely disappointed that the proposed policy appears to exclude PET scans for breast cancer patients. The AMI believes that the oversight could be attributed to the conclusions of an earlier decision memo (Decision Memo for Positron Emission Tomography (FDG) for Breast Cancer, CAG-00094N, February 2002), which made recommendations for PET coverage/non-coverage based on three types of assessments: 1) sufficient evidence to suggest that FDG-PET was efficacious, 2) insufficient evidence to show that FDG-PET was efficacious, and 3) minimal evidence indicating that FDG-PET was not beneficial.

Despite intimations in the memo itself suggesting a need for additional data and further analyses, the 2002 memo resulted in a non-coverage decision for those indications where there was insufficient evidence to determine the efficacy of PET. More unfortunately, because of this earlier consideration, the 2002 recommendation for these indications has not been re-evaluated in the 2004 draft decision memo although clearly the field, with its limited data and low-resolution scanners, was still developing.

For this reason, AMI advocates that breast cancer indications not be excluded for coverage in the November 2004 decision memo. To this end, AMI recommends:

1) The following sentence be deleted from the 2004 decision memo: “All other previous national non-coverage determinations based on evidence of lack of benefit will remain in effect,” and

2) Appendix C be amended to state that breast cancer patients will qualify for coverage.

Once again, AMI is very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. AMI is committed to working with CMS to design a National Patient Data Registry for the collection of patient management data regarding PET scans, believing that such a policy would foster the growth of peer-reviewed evidence on the effectiveness of PET in the diagnosis and management of cancer and allow CMS to make decisions using evidence based medicine while offering broad coverage to Medicare patients with cancer. We only ask that breast cancer victims receive the same consideration and benefits that will very rightfully be made available to those patients with other types of cancer.

Thank you very much for your attention to this very important matter.

Sincerely yours,

R. Edward Coleman, M.D.

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Dear Dr. McClellan:

On behalf of Radiology Corporation of America, I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

Sincerely yours,

Monroe R. Meyerson
Chairman of the Board

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As a PET technologist for the past 4 years, I have seen where PET has greatly helped patients diagnosed with brain, cervical, ovarian, pancreatic, small cell lung cancer, and testicular cancers. It has often changed the course of treatment, saved patient from unnecessary surgery, discovered areas of metastases that were not picked up by any other diagnositic modality, and confirmed whether the patient was responding to treatment. Please, please consider coverage for patients with these cancers. PET has made a definite impact in these patients' care.

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I am writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). We are very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. This policy would increase access for Medicare beneficiaries to PET scans for all cancer indications. Additionally, this expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer.

In oncology, PET is the most accurate non-invasive way to show whether or not a tumor is malignant or benign. PET reveals metastatic disease other imaging techniques cannot detect because it can inspect all organs of the body in a single examination to determine whether a primary cancer has spread to other parts of the body. Anatomic imaging tends to identify disease at later, more severe stages, is less accurate in separating malignant from benign processes, and misses disease identified by PET. PET is also cost-effective for the Medicare program. PET can eliminate unnecessary surgeries, and reduce the number of diagnostic procedures.

Initially, CMS undertook an extensive coverage review for cancer on an indication by indication basis. Over the past five years CMS has made numerous national coverage decisions on PET for cancer. This has been a lengthy process for CMS and providers. Now that the majority of cancers are covered by CMS, it would be impracticable to submit individual coverage requests for all of the dozens of remaining rare cancer indications. Coverage of PET for all cancer indications is based on clinical practice and medical evidence and is also sound public policy.

Clinicians from leading academic medical centers have submitted data and evidence to CMS on the benefit of PET for diagnosis of pancreatic, brain, small cell lung, cervical, ovarian, multiple myeloma and testicular cancer. PET is equally effective for these lesser prevalent cancers as it is for covered indications like lung and breast cancer. I was disappointed that the draft coverage decision did not include a positive coverage policy on these cancer indications based on all of the evidence submitted to CMS. I respectfully request that the final coverage decision include a positive coverage decision for these cancer indications based on the submitted data.

We look forward to working with you to expand the coverage of PET scans for Medicare beneficiaries with cancer. Patient data registry would allow CMS to make decision on evidence based medicine and at the same time offer broad coverage to Medicare patients with cancer.

Thank you very much for your attention to this matter.

Sincerely yours,
David M Schuster, MD
Department of Radiology
Division of Nuclear Medicine
Emory University Hospital
Room E145
1364 Clifton Road
Atlanta, GA 30322

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The Academy of Molecular Imaging (AMI) is writing to comment on the draft national coverage decision posted on November 1, 2004 on the expanded coverage of positron emission tomography (PET). The AMI is comprised of physicians, providers and researchers focusing on nuclear medicine and the use of PET to advance the treatment and management of patients with cancer. The AMI appreciates the efforts of the CMS’ Coverage and Analysis Group over the past several years in reviewing PET scans technology. PET scans are a breakthrough technology and CMS has devoted considerable attention to their review. At present Medicare covers PET for eight of the leading cancer indications. Over the past two years AMI has been working with CMS to expand PET coverage for the remaining cancers. At present these cancers are noncovered by CMS which prevents carriers from allowing coverage in cases where a PET scan can benefit a patient.

Over the past two years clinicians and oncologists from leading academic medical centers have worked with CMS on the coverage of PET for cervical, ovarian, brain, testicular, small cell lung, and pancreatic tumors. AMI was discouraged that after a lengthy review CMS only found sufficient evidence for a positive coverage decision for PET in cervical cancer. Moreover, the coverage decision for cervical cancer is limited and did not recognize all of the published literature on cervical cancer. AMI believes the evidence warrants a positive coverage decision for each of these cancers and the final NCD should include a positive coverage decision based on the submitted evidence.

AMI is very supportive of the draft NCD coverage policy that would both expand coverage of PET scans for all remaining non-covered cancers and collect more patient management data on the use of PET with these cancers. For the leading PET indications that are covered by Medicare, there have been many peer review publications that present evidence on the benefits of PET in the management of patients with cancer. Medicare coverage of these indications has greatly increased the available peer reviewed literature on these cancers, and this literature supports the decision of CMS to cover these cancers. However, it has been difficult to publish peer review articles or to do large clinical studies without Medicare coverage for the less prevalent cancers. This expanded coverage policy would foster the growth of available peer reviewed evidence on the effectiveness of PET scans in the diagnosis and management of Medicare beneficiaries with cancer. AMI is committed to working with CMS to design a National Patient Data Registry for the collection of patient management data regarding PET scans. In the draft NCD CMS stated that the following data elements should be included:

As a physician interpreting PET/CT scans for more than 1 and 1/2 years I have had the opportunity to image several patients with pancreatic cancer, ovarian cancer, and leiyomyosarcoma of the uterus. IN some cases only the PET scan identified the primary and in all cases was significantly more accurate in assesing the extent of disease. I hyave also had some experience with small cell lung carcinoma. PET was also reliable in assesing the extent of disease in this patient. I feel strongly that these neoplasms should be included in the list of approved conditions for which PET imaging is reimbursed.

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I receive calls on a weekly basis from clinicians wanting to discuss whether a PET scan would be appropriate or not to further investigate a patient condition. I often find myself having to say that the PET scan is likely to provide critical information that would positively impact on patient management. However, this particular cancer/indication is not covered by Medicare at this time, therefore the patient will not have access to this test. This is an unfortunate situation both for the patient who cannot be helped and for the physicians who are not allowed to use the tools they have at their disposal. Of course most patients cannot afford to pay for a PET scan out of pocket.I fully support broad Medicare coverage for most cancers.

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PET and PET/CT in the Evaluation of Patients with Gynecologic Malignancies

To Whom It May Concern:
At UPMC hospitals in general and Magee-Womens Hospital specifically, we believe that PET scanning is a powerful tool for the staging and monitoring of treatment for both cervical cancer and ovarian cancer. Currently we are evaluating the added benefit of PET/CT. Our preliminary data is very compelling to support the notion that PET/CT offers a significantly greater benefit than CT or PET alone (or even the two modalities in combination). Our experience, and the experience of others (provided as a reference list with this memorandum) have convinced us that the time for reimbursement has clearly arrived. In addition to the references provided please see the attached summary Powerpoint presentation prepared by one of our residents, Dr. Todd Blodgett, for an interesting summary of the use of PET/CT in staging and monitoring Gynecologic Malignancies.

There are approximately 56 references supporting the use of FDG PET in patients with cervical cancer and 63 references supporting its use in patients with ovarian cancer. Although several different potential applications have been explored, the majority of the evidence suggests that FDG PET is more helpful than CT in staging patients with cervical cancer, particularly in identifying pelvic, paraaortic and distant supraclavicular lymph nodes. Combined PET/CT will also play an increasingly important role in these patients for radiation therapy planning. Because both CT and PET data can be imported into most radiation therapy planning systems, it will facilitate defining the anatomical and functional extent of tumor. This will be imperative in cases where the true extent of tumor involvement is not apparent on CT. For ovarian cancer, there is very good evidence to support its use at the very least in patients with rising CA-125 with a negative or equivocal CT scan.

Sincerely,
Jules H. Sumkin, D.O., F.A.C.R.
Chief of Radiology Magee-Womens Hospital
Professor of Radiology University of Pittsburgh
School of Medicine

Todd Blodgett, M.D.
Resident UPP Department of Radiology

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I am a Nuclear Radiologist practicing in Columbia, South Carolina. Our hospital was the first in our state to offer positron imaging, first with coincidence imaging, and then with a dedicated PET scanner. The information provided has proven to be invaluable to our patients and their care.

I would strongly urge the approval of reimbursement for the additional cancers listed above. Our literature shows that PET scanning can have similar efficacy with these entities as well as the more common lesions already approved. This would give us a very important tool for our diagnostic armamentarium.

Please feel free to contact me if I can provide any further information.

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As a practicing Nuclear Medicine physician, I feel it is imperative to expand PET to the tumors currently being considered by CMS. My opinion is certainly personal, but more importantly, the vast growing body of scientific literature leaves little doubt the that the addition of true physiologic information via PET to the anatomic data provided by scans such as CT scans is absolutely invaluable in these tumors. Many, many patients will benefit from PET information about their tumors (either positive or negative PET scans have a great impact).

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This piecemeal process of granting reimbursement for one or two forms of cancer at a time is wasteful of resources (e.g. frequent and often useless CT and MRI scans) and denies patients access to an imaging modality which has great power to determine the appropriate treatment for individual patients. CMS should relax restrictions so that any malignancy which concentrates F18 deoxyglucose should be reimbursable. Doctors will use the modality if it proves beneficial to patients and will not if it does not.If CMS wants to save money, they should enforce and extend the Stark laws to deter self-referrals of expensive imaging studies.

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