Positron Emission Tomography (FDG) for Solid Tumors

I previously stated that the CMS PET policy should be extended to cover all cancers at all stages of the disease. I referred to our data from last years'' SNM meeting in ovarian carcinoma. We have additional data of relevance to the role of PET/CT in ovarian cancer vs serological assessments. These data should help CMS decide to more broadly cover PET/CT in ovarian cancer (as well as other cancers). Javadi, Bristow and Wahl have submitted the following data (in part) for presentation at the upcoming SNM meeting. More data will be added by June:

In brief: 30 females with stage III/IV ovarian cancer were assessed for disease status with PET/CT (n=157) and serial CA-125 levels. 51% of the scans were restaging and 49% to assess therapy response. Disease state was derived from all available clinical data. CA-125 was analyzed by the Bristow criteria, described as positive for recurrence with an increase of 5 or more U/mL or a doubling from nadir. GCIG criteria were also assessed, with recurrence predicted in cases of marker doubling the upper limit of normal.

RESULTS:

PET/CT sensitivity in detecting recurrence was 90%, superior to CA-125 analysis using the Bristow (58%) or the GCIG (26%) criteria. PET specificity was 91%, Bristow 89%, and GCIG 100%. PPV of PET, Bristow and GCIG methods were 91%, 85% and 100% respectively. NPV with PET, Bristow, and GCIG was 90%, 67% and 57% respectively.

These data support the use of PET/CT in ovarian cancer for restaging and treatment monitoring. It would be devastating to women with ovarian cancer to be denied coverage for PET/CT imaging in this disease, especially since they have had it through CED.

We will have additional data showing that patients rendered pet negative post surgery after a positive PET/CT have a favorable outcome in terms of PFS by June.

Thus, I implore CMS to assure patients with ovarian, and other cancers, continue to have access to CMS paid PET/CT scans at all stages of their disease.

This will NOT occur if the proposed coverage document is enacted unchanged.

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I am a radiologist and nuclear medicine physician with a departmental appointment in oncology. On a daily basis I work with my colleagues at Johns Hopkins to solve clinically relevant patient care questions using PET/CT imaging. I also served on the CMS MCAC advisory committee for four years and on the recent CMS advisory panel evaluating evidence for broadening coverage with PET. I have over 20 years experience with oncologic PET and have contributed to the biological understanding of the signal identified by PET imaging. As I pointed out in the CMS advisory panel, examining only the last several years of data in several additional cancers did not do justice to the full clinical and biological rationale for PET imaging. Realizing that modern biology indicates increased glycolysis is a very common survival pathway for cancers means broad biological truths underlie the workings of PET/CT imaging. To view each cancer as an "independent and unrelated biological process" which can only be evaluated by a strict "evidence based" approach involving randomized studies in each disease ignores virtually completely the biological basis for disease and for PET imaging. This is somewhat like CMS telling a pathologist that a microscope can only be used on specific cancers, as the optical technique cannot be generalized. Thus, I feel the coverage decision has not gone far enough based on the considerable biology underlying PET imaging and the wealth of clinical experience supporting its utility.

In the vast majority of cancers, PET is more accurate and predictive of outcomes than is anatomic imaging alone. Thus, it is a flaw of the proposed NCD to only cover a baseline PET scan in the "less common" cancers like pancreatic or ovarian. It is a virtually untenable and illogical position to be able to identify and assess cancer but to be unable to follow it after treatment, especially when treatments are so often distorting of normal anatomic landmarks, like surgical/radiaton treatment of pancreatic cancer. We have recently reported on the use of PET/CT to plan radiation therapy. The inability to use this technique under the proposed NCD is not in patients''s best interests as this may be a an "uncovered second scan". We have used PET/CT in over 200 patients with pancreatic cancer at our center most commonly in the restaging setting. Not having this ability with the "one PET/yr and you''re out" policy the NCD proposes would be seriously disruptive to patient care.

Similarly, we have recently reported on the use of PET/CT in monitoring ovarian cancer patients during treatment. Indeed, we now use PET/CT as our main imaging test in ovarian cancer management no longer doing CT scans alone. We have found the CA-125 level is much less reliable than PET/CT in management (in an analysis of a cohort of 110 FDG PET/CT scans, we found a sensitivity/specificity of PET/CT of 96%/92% vs 54%/82% for CA-125)Javadi et al SNM 2008. ) Thus, PET/CT is better than the standard blood test. Without the CMS registry we would not have been able to obtain these data. Now that we are very confident of the superior performance of PET/CT vs other methods, it seems highly unfair to deny patients with ovarian cancer the opportunity for follow up PET/CT studies as is proposed by the NCD. Should the oncologist treat based on their best guess? I''d think use of the accurate imaging test would be more rationale and make better use of resources.

We also have used the ability of PET/CT to predict outcomes early on in treatment (treatment monitoring) to adapt our therapies to be more intensive in lymphoma patients who are not responding well. We have recently reported very favorable outcomes in this group of patients with NHL whose treatment was monitored by PET/CT and whose treatment was then "adapted" to be intensified in only those who needed it. The overall PFS in the high risk group appears comparable to that of the lower risk group indicting the approach to work in the initial study (Kasamon, Wahl, et al Biol Blood Marrow Transplant. 2009 Feb;15(2):242-8). In brief "To determine the outcome of early treatment intensification for midtreatment PET-positive disease, a phase II trial of risk-adapted therapy was conducted. Fifty-nine newly diagnosed patients, 98% with B cell lymphoma, had PET/CT performed after 2 or 3 cycles of first-line chemotherapy. Those with negative PET on semiquantitative visual interpretation completed standard therapy. Those with positive PET received platinum-based salvage chemotherapy, high-dose therapy, and autologous stem cell transplantation (ASCT). Midtreatment PET was positive in 33 (56%); 28 received ASCT with an actuarial 2-year EFS of 75% (95% confidence interval, 60%-93%). On intention-to-treat analysis, 2-year EFS was 67% (53%-86%) in all PET-positive patients and 89% (77%-100%) in PET-negative patients. No association was found between the International Prognostic Index category and the midtreatment PET result" . Thus, treatment monitoring PET did well in this setting.

Given that, for example, pancreatic cancer and ovarian cancer are being managed using PET/CT on a routine basis, the NCD proposed will be clearly disruptive to patient care, in that follow up scans will not be feasible until a new set of CED is set up.

The data with the NOPR are quite conclusive as is my daily practice with very bright medical, radiation and surgical oncologists, surgeons, and GYN oncologists. PET/CT is generally useful in the diagnosis, staging, restaging, treatment monitoring and radiation therapy planning of nearly all cancers.

While acquiring more scientific data is always attractive, this must be balanced vs. the data from nearly 100,000 patients already entered on the NOPR showing management changes are quite common in all cancers.

I strongly urge CMS to provide broad coverage for PET/CT imaging of cancer at all phases in the management of the disease. I think CMS can better devote its resources to examining other issues in medical care delivery now that it is clear that PET is a generally useful method.

If CMS does wish to obtain additional data under CED, it is critical that current coverage under CED does not lapse, as it is clear it is useful to doctors managing cancer patients. If additional CED is obtained, I would suggest it be limited only to the areas of Radiation treatment planning and treatment response monitoring.

Under separate cover, I will provide to CMS the relevant published manuscripts which would not have been completed without the NOPR.

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Dear Centers for Medicare & Medicaid Services:It is with great enthusiasm I applaud two proposed modifications in the PDM as vital steps in the advancement of Medicare PET and PET/CT coverage. The expanded coverage to tumor types not currently covered by Medicare’s current coverage will be especially beneficial for the diagnosis and initial staging of many types of cancer. In addition, condensing the four categories of indications (diagnosis, staging, restaging and therapy monitoring) to two (initial treatment and subsequent treatment) will expand coverage to patients who can realize benefits during therapy for therapy monitoring. There are however, two areas in which the PDM falls short and I would like to bring these concerns to your attention. As Medical Director of Diagnostic Services for Kansas City Cancer I have had the opportunity to interpret over 10,000 PET and PET/CT procedures and have concerns with limiting coverage to only one scan for determination of initial diagnosis or initial staging. PET and PET/CT are critical modalities used to diagnose, stage and restage certain types of cancer. Patients frequently require subsequent imaging to monitor and restage their cancer during and after treatment. It’s critical a patient is reassessed using the same modality that was used in initial treatment. I urge CMS to expand coverage to include subsequent imaging in order to adequately stage and restage patients. As a radiologist that focuses primarily on oncological imaging, the use of PET and PET/CT continues to be a proven modality in terms of sensitivity and specificity for many types of tumors compared to other imaging modalities. PET and PET/CT are vital to improving patient outcomes, reducing costs and preventing surgery. Specifically, incorporating PET and PET/CT prevents unnecessary biopsies, assists surgeons on the appropriate site to biopsy, and helps medical and radiation oncologists make better treatment decisions. In summary, I applaud CMS with the proposed expansion of coverage and urge your consideration to expand coverage to include the subsequent imaging of the additional tumor types proposed in the PDM. People are living longer with cancer. In everything we do, Kansas City Cancer Center embraces and celebrates this evolution of patient care. Our mission is grounded in hope, compassion and an unwavering dedication to providing the highest quality cancer care from diagnosis through treatment and beyond. PET and PET/CT are proven modalities for the diagnosis, staging and restaging of many types of cancers, and I thank you for your review and consideration of the concerns outlined here within.

Sincerely,
Mark Perry, M.D.
Medical Director, Diagnostic Services
Kansas City Cancer Center, LLC

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I support the proposed decision memorandum for an omnibus approach to PET and PET/CT for Initial Treatment (formerly diagnosis and staging), with specific exclusions for prostate cancer, as well as regional lymph node staging in breast cancer and melanoma.

I urge CMS to modify the proposed decision memorandum for Subsequent Treatment (formerly restaging and monitoring) to include the same omnibus considerations for PET and PET/CT when MR or CT cannot be performed due to the risk of adverse reaction to intravenous contrast media, or when MR cannot be performed because of magnetic material within the body.

The number of patients who cannot have CT or MR is small. PET and PET/CT is extremely important in these individuals for Initial Treatment as well as Subsequent Treatment decision making. It is untenable to perform PET and PET/CT for Initial Treatment, but not be able to use it subsequently for medical decision making when there is no reasonable alternative.

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As a Radiologist, I encourage CMS to expand PET and PET/CT coverage to address all cancers for diagnosis, staging and restaging. The proposed structure will help reduce the miscategorization of scans due to semantics. For example, some PET scans are ordered for the initial diagnosis of cancer; however by the time the scan is performed, it may instead be for the purpose of staging the cancer if the biopsy results have since confirmed a diagnosis. Also, many medical oncologists do not see a clear delineation between treatment monitoring and restaging in many cases. Placing cases into the two categories, “initial treatment” and “subsequent treatment”, may reduce much of the confusion.

I believe the evidence supports the broad expansion of coverage of FDG PET imaging to all solid tumors when determining initial treatment strategy. The current peer-reviewed literature has long supported the use of PET/CT as a part of the initial work-up in patients with a wide variety of solid tumors. PET/CT has been shown to be cost-effective in that it is frequently able to help patients avoid futile surgeries and procedures through clearer delineation of the true extent of disease. PET/CT as a single modality has proven more accurate than the combination of multiple conventional imaging modalities in the vast majority of cancer types. As a result, PET/CT has allowed a change in treatment strategy in at least one out of every three patients. The utilization of PET/CT early in the evaluation of cancer will allow more appropriate patient management.

I believe that as useful as PET/CT is for guiding the management of patients at initial workup, it is equally, if not more effective, for evaluating patients during and following treatment and for the detection of recurrence. The majority of patients with cancer have received surgery and/or radiation therapy both of which may cause permanent alterations to the anatomy. These anatomic changes are not clearly discernable from tumor activity on conventional anatomic imaging such as CT and MRI scans. The addition of metabolic and anatomic information in a single, whole-body PET/CT scan allows assessment of the true extent of tumor activity earlier and more accurately than multiple conventional imaging modalities combined. For example, scar tissue and radiation fibrosis can often mask local recurrence of cancers on conventional anatomic imaging. Patients with local recurrence may often be candidates for local salvage therapies which may have a significant impact on their outcomes. PET/CT can differentiate active disease from scar tissue, allowing earlier intervention for recurrence when it may be localized rather than waiting for the recurrence to become disseminated.

PET/CT has been proven in multiple peer-reviewed studies to identify patients who are not responding to treatment at earlier time intervals than conventional imaging modalities due to the fact that metabolic changes generally precede anatomic changes. This earlier identification of a lack of treatment response can result in the discontinuation of expensive, ineffective therapies, saving a patient the toxicities associated with ineffective therapy and allowing the earlier initiation of potentially more effective agents.

Thank you for the opportunity to provide comments on this issue.

James Fleckenstein, M.D.

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February 5, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R)

Dear Dr. Phurrough:

The Association for Freestanding Radiation Oncology Centers (AFROC) is delighted to have this opportunity to comment on the Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R) (the “Proposed NCD)”) posted by the Centers for Medicare and Medicaid Services (CMS).

The Proposed NCD announces CMS’s plan to replace the current four-part analytical framework for evaluating coverage of FDG PET (based on diagnosis, staging, restaging, and monitoring) with a simplified and more streamlined two-part framework that differentiates FDG PET used for initial diagnosis from FDG PET imaging used to guide subsequent treatment. We understand that, under the Proposed NCD, T FDG PET would be covered for the initial diagnosis of solid tumors, based on the judgment of the beneficiary’s treating physician, and to do so without requiring participation on the NOPR. We fully concur in this assessment: The NOPR has served its purpose and that further data collection is not necessary to conclude that the performance of FDG PET is appropriate for initial cancer diagnoses.

We further understand that the use of FDG PET in determining subsequent treatment strategy for FDG PET in the subsequent treatment strategy of breast, cervix, colorectal, esophagus, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid cancers would be covered without evidence development. However, the use of FDG PET for subsequent treatment stragegy for brain, ovary, pancreas, prostate, small cell lung, soft tissue sarcoma, and testes cancers would be covered if, but only if, the patient is enrolled in, and the FDG PET provider is participating in, an approved registry or other study for the collection of clinical data.

We urge CMS to clarify to proposed NCD to ensure that more than one FDG PET study is covered, without evidence development, for patients whose initial treatment strategy includes radiation therapy planning. FDG PET is extremely useful in radiation therapy planning to accurately target tumor volume and to avoid the application of radiation to healthy tissue. But PET scans utilized for the purpose of radiation treatment planning often focus on a more limited anatomical area than the initial PET scan. Also, a PET scan performed for the purpose of radiation treatment planning is performed with the patient in a different position that the position used when the PET scan is intended for initial diagnosis or staging. Under the Proposed NCD, it appears that PET scans that are taken for the purpose of radiation treatment planning may not be covered for Medicare patients who already received another scan. We urge CMS to reconsider this issue and to clarify in the final decision that a second FDG PET study will be covered for patients who require radiation therapy and the second PET scan is used for the purposes of tumor localization.

We appreciate this opportunity to submit these comments and again express our appreciation to CMS for its careful consideration of the issues involved.

Respectfully submitted,

David Rice, MD
President
Association for Freestanding Radiation
Oncology Centers

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Thank you for the opportunity to comment on the Draft National Coverage Decision for Positron Emission Tomography for Solid Tumors. The University of Kansas Hospital in conjunction with the Kansas University Medical Center has participated in the National Oncological PET Registry (NOPR). We have included results of those NOPR Pet Scans along with quotes from ordering physicians as part of our comments below.

COMMENTS:

PROPOSED FRAMEWORK FOR INITIAL VS SUBSEQUENT TREATMENT

We have concerns about the NCD framework which covers the same PET Scans differently based on the patient receiving Initial vs Subsequent Treatment. We understand that the previous categories of Diagnosis/Staging are being rolled into Initial Treatment and Restaging/Monitoring are being rolled into Subsequent Treatment. However, the definition is still difficult to communicate to the ordering physicians. And, it is difficult to gather from the ordering physicians the information needed on a PET Scan requisition to know whether the scan will be covered. We request that consideration be given to eliminating these separate categories or making the distinction more clear.

OVARIAN CANCER

We request consideration of covering PET scans for subsequent treatment in addition to initial treatment. As a part of the NOPR, we performed 9 PET Scans for Ovarian Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

BLADDER CANCER (We assume this is in the category of ‘All other solid tumors’.)

We request consideration of covering PET scans for subsequent treatment in addition to initial treatment. As a part of the NOPR, we performed 13 PET Scans for Bladder Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

Dr. Peter Van Veldhuizen, Professor, Kansas University Medical Center Department of Hematology/Oncology, comments, “PET scan is extremely helpful in assessing nodal and metastatic disease in patients with transitional cell carcinoma of the bladder or urinary tract/renal pelvis. In most all circumstances, PET scan correlated with exam or other radiograph imaging either done prior to PET scan or to confirm positive PET scan results. PET positive areas also correlated with subsequent areas of disease progress. I think PET is very helpful in both initial staging and reassessment of disease in this patient population.”

BRAIN CANCER

We request consideration of covering PET scans for subsequent treatment in addition to initial treatment. As a part of the NOPR, we performed 3 PET Scans for Brain Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

Dr. Sarah Taylor, Professor, Kansas University Medical Center Department of Hematology/Oncology and Director of the Fellowship Program in Clinical Oncology, comments, “We use the FDG PET scan in conjunction with MRI Spectroscopy to help discriminate pseudoprogression from tumor progression and find it useful. This has allowed us to more safely postpone surgery.”

KIDNEY CANCER (We assume this is in the category of ‘All other solid tumors’.)

We request consideration of covering PET scans for subsequent treatment in addition to initial treatment. As a part of the NOPR, we performed 9 PET Scans for Kidney Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

Dr. Peter Van Veldhuizen, Professor, Kansas University Medical Center Department of Hematology/Oncology, comments, “In patients with PET avid tumor, we find PET very helpful in determining disease extent with good correlation with other scans and ultimate disease progression. Fair percentage of patients though did not have PET avid tumor so has not been universally beneficial. Definitely though would like to have it available as it has been helpful, especially in patients with presumed isolated local or solitary recurrence. In this patient population, in most of my cases, if this recurrence is PET avid, has been helpful identifying whether or not there are other areas of disease and definitely adds value in identifying areas not seen on bone scan/ct scans.”

MULTIPLE MYELOMA (Is Myeloma addressed in this policy?)

We request consideration of covering PET scans for both initial and subsequent treatment. As a part of the NOPR, we performed 31 PET Scans for Myeloma with the following findings as compared to the physician assessment based on other diagnostic tools:

Dr. Delva Deauna-Limayo, Associate Professor, Kansas University Medical Center Department of Hematology/Oncology, comments, “PET scan is very sensitive in assessing disease in myeloma, both medullary and extramedullary disease. It is particularly helpful among patients with non- secretory myeloma, and in some cases, may be the only modality to evaluate disease among such cases without measurable disease short of performing bone marrow biopsy. One other advantage is its ability to assess the whole body with just one scan. In evaluating lytic or bone disease in MM, the skeletal survey could miss up to 25% of the cases. MRI has better sensitivity but would need several scans to evaluate the whole body. In some cases, it changes the management plan from observation to initiation of systemic therapy. Also helpful in response assessment.”

STOMACH CANCER (We assume this is in the category of ‘All other solid tumors’.)

We request consideration of covering PET scans for subsequent treatment in addition to initial treatment. As a part of the NOPR, we performed 5 PET Scans for Stomach Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

Dr. Mazin Al-Kasspooles, Associate Professor, Kansas University Medical Center Department of Oncologic Surgery, comments, “I found PET scanning very useful in staging patients with gastric cancer. In fact, most patients were found to have disease not present on conventional imaging often leading to a change in clinical management.”

UTERINE CANCER (We assume this is in the category of ‘All other solid tumors’.)

We request consideration of covering PET scans for subsequent treatment in addition to initial treatment. As a part of the NOPR, we performed 18 PET Scans for Uterine Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

PROSTATE CANCER

Since FDG PET has been proven to be less accurate than ProstScint in detecting prostate cancer, and in the best studies ProstaScint has a sensitivity of only 63% for detecting recurrent disease, we would request consideration be given to future NOPR investigations utilizing C11- acetate PET for initial staging and evaluating biochemical recurrence in prostate cancer. At our institution we have performed over 110 C11- acetate PET scans for prostate cancer recurrence. In our prospective, blinded comparison of 20 patients with biochemical recurrence, defined as a rise of PSA to > 0.2 ng/ml post radical prostatectomy, we found C11- acetate PET to have a sensitivity of 85% while ProstaScint had a sensitivity of only 30% for this group of 20 patients with a mean PSA value of 1.03 and tumor sizes < 1 cm.

As a part of the NOPR, we performed 8 PET Scans for Prostate Cancer with the following findings as compared to the physician assessment based on other diagnostic tools:

Dr. Peter Van Veldhuizen, Professor, Kansas University Medical Center Department of Hematology/Oncology, comments that, “In isolated patients, FDG PET has been helpful but frequent false negative results, even in the setting of significant PSA evaluation, or in patient with known metastatic disease it frequently does not help in determining the extent of disease. Overall, FDG PET has not been that helpful clinically except in isolated cases.”

In summary, we applaud your work in trying to bring the most cost effective diagnostics to the field of oncology. Thank you again for the opportunity to provide our comments. Please feel free to contact us if you have any questions or would like additional information.

Sincerely,

Patricia Sanders-Hall, MA, FACHE
Vice-President, Ancillary Care
University of Kansas Hospital

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PET via the registry has been extremely important for my clinical management of pts, restaging in particular. SCLCA post RT often has CT noted fibrosis; PET helps determine underlying active disease. Ovarian and endometrial often recur with subtle disease, especially peritoneal carcinomatosis, which can show up as a vague infiltrate on PET, but not on CT at all and early therapy is important to protect against hospitalization for symptomatic disease. Prostate PET helps with locally advanced disease/recurrence post RT, and is better than bone scans to monitor response.

I remain in complete favor to liberalize the indications for PET/CT,despite it''s cost (ultimately reduced by earlier clinical management), due to the important info gleened for appropriate cancer management.

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February 5, 2009

RE: Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R))

Dear Dr. Phurrough,

Society of Gynecologic Oncologists (SGO) thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to comment on the draft decision memorandum on Medicare coverage of Positron Emission Tomography (PET) for cancer.

The SGO is a national surgical specialty society of physicians who are trained in the comprehensive management of women with malignancies of the reproductive tract. Its purpose is to improve the care of women with gynecologic cancer by encouraging research, disseminating knowledge which will raise the standards of practice in the prevention and treatment of gynecologic malignancies, and cooperating with other organizations interested in women''s health care, oncology and related fields. SGO is the leading organization of gynecologic oncologists in the United States.

We are writing to voice our general support of the framework outlined in the draft decision memo, but we would like to express our concern with CMS’ decision to continue “coverage with evidence development (CED)” for the use of FDG- PET for “subsequent treatment strategy” for ovarian cancer. The SGO urges CMS to address this issue in its final coverage decision as it has been shown that FDG-PET for re-staging and the management of recurrent disease does affect clinical decision making and treatment decisions in a significant proportion of ovarian cancer patients. Gynecologic oncologists use PET and PET-CT to determine which patients with recurrent ovarian cancer are candidates for secondary cytoreduction surgery versus chemotherapy alone. Therefore, SGO believes that the CED requirement should be removed for ovarian cancer, as well.

In the December 2008 volume of the Journal of Nuclear Medicine, Dr. Bruce E. Hillner, et al published data from the National Oncologic PET Registry (NOPR) regarding the change in intended management by specific cancer types and indications for testing, specifically staging, re- staging, and detection of recurrence disease. For ovarian cancer, there were over 4,500 non- initial diagnosis scans available in the NOPR and it was found that in almost 45 percent of these scans the plan for management of the patient’s ovarian cancer was subsequently changed based on the results of the FDG-PET scan. Also, the impact of FDG-PET performed for the detection of suspicious recurrence was by far the greatest in ovarian cancer.

Furthermore, in a draft Technology Assessment commissioned by the Agency for Health Care Quality and Research (AHRQ) published on September 23, 2008 entitled, “Positron Emission Tomography for Nine Cancers (Bladder, Brain, Cervical, Kidney, Ovarian, Pancreatic, Prostate, Small Cell Lung, Testicular)” it concluded that the majority of the literature on FDG-PET for ovarian cancer is the detection of recurrences following treatment, which under CMS’ proposed coverage decision would be considered, “subsequent treatment strategy.” The assessment states that “Meta-analyses of the diagnostic accuracy of both 18FDG-PET and 18FDG- PET/CT showed a consistent, statistically significant effect in both the positive and negative LRs across a range of reference standards and study designs, providing evidence to support the usefulness of 18FDG-PET and 18FDG- PET/CT in detecting ovarian cancer recurrences.”

Finally, the journal, Gynecologic Oncology, has recently published two articles on the use of PET and PET-CT in the subsequent management of ovarian cancer. An article by Dr. Michael Soussen, et al published the findings of a group of 29 women who were originally treated for ovarian cancer and then presented with an elevated CA-125 regarding the use of CT versus PET-CT to manage the possibility of recurrent disease. The questionnaire-based study showed that PET-CT imaging allows for better restaging of ovarian cancer versus CT alone and that it induces a change in clinical management in over 1/3 of patients with suspected recurrence on an increased CA-125.

The second article by M.J. Fulham, et al, while conducted in Australia, reported on a cohort of 90 women in a prospective, multi-center trial to assess the impact of FDG-PET-CT on the management of patients with suspected recurrent ovarian cancer. This study concluded that for these women with previously treated ovarian cancer with recurrent disease, PET-CT can alter management in close to 60 percent of the patients.

As a result of these additional findings, we urge CMS to reconsider and provide full coverage, without CED requirements for “subsequent treatment strategy” for ovarian cancer.

SGO appreciates the opportunity to comment on the draft decision memo and would be pleased to provide CMS with any additional information that may be valuable. Should you have any questions, please feel free to contact Jill Rathbun at 703- 486-4200. We look forward to the final NCD and thank you for your consideration of our comments and concerns.

Sincerely,

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February 5, 2009

Charlene M. Frizzera
Acting Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

RE: Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R)

Dear Ms. Frizzera:

On behalf of the American Cancer Society Cancer Action Network (ACS CAN) and its many volunteers and supporters, we respectfully submit the following comments for your consideration regarding the proposed decision memorandum for positron emission tomography (FDG) as published on January 6, 2009.

As the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society (the Society), ACS CAN is committed to ensuring that our nation’s seniors have access to high quality cancer prevention, early detection, and treatment tools through the Medicare program. As you may know, cancer is a disease that disproportionately affects the elderly-according to the Society’s 2008 Facts & Figures, more than 70 percent of all new cancer diagnoses occur in the elderly population. Given the important role positron emission tomography (FDG) plays in cancer treatment and staging, ACS CAN appreciates the opportunity to provide comments on the proposed decision memorandum and looks forward to working with CMS to strengthen the Medicare program.

ACS CAN is pleased that CMS has proposed to expand coverage of PET-FDG for initial treatment planning. The additional information provided by PET-FDG scans enables physicians to determine the best course of treatment for each individual patient. ACS CAN believes this decision will ensure that cancer patients receive timely and well-informed information so that they and their doctors can decide upon the best treatment options.

ACS CAN would also like to commend CMS for supporting continued evidence collection for use of PET-FDG for subsequent treatment decisions. The data from the NOPR supports CMS’ decision to expand coverage for PET-FDG to include treatment monitoring. As the results reported by the National Oncologic PET Registry (NOPR) made clear, PET-FDG scans led to a change in management for more than a third of all cases. ACS CAN believes that use of PET-FDG is a valuable tool for both physicians and their patients when it is necessary to determine whether there has been a recurrence or simply to monitor response to treatment. In addition, by clarifying PET-FDG coverage as either related to a patient’s initial treatment or treatment monitoring, CMS has simplified the its coverage policy so that it can be more readily understood by physicians and patients.

Thank you again for your efforts to provide quality cancer care to the millions of cancer patients in the Medicare program. We look forward to working with you on these issues.

Sincerely,

Daniel E. Smith
President
American Cancer Society Cancer Action Network

cc: Dr. Steve E. Phurrough
Director, Coverage and Analysis Group

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February 5, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R)

Dear Dr. Phurrough:

Philips Healthcare (Philips) is delighted to have this opportunity to comment on the Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R) (the “Proposed Decision”) posted by the Centers for Medicare and Medicaid Services on January 6, 2008. Philips operates in five main business areas: Diagnostic Imaging Systems, Clinical Solutions, Healthcare Information, Customer Services and Home Healthcare Solutions. Our product line includes best-in-class technologies in X-ray, ultrasound, magnetic resonance, computed tomography, nuclear medicine, PET, radiation oncology systems, patient monitoring, information management, personal emergency response systems, and resuscitation products.

Philips strongly supports the proposed framework to allow care providers to decide the optimal use of PET in the patient management process. The new, streamlined coverage framework (“initial treatment” and “subsequent treatment”) is a significant improvement upon the previous four-category coverage framework.

We are also supportive of the decision to provide coverage for initial treatment for new indications that were covered previously only under NOPR framework. It is our understanding that CMS is expanding coverage of FDG PET for the initial diagnosis of virtually all solid tumors that are biopsy- proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor.

The proposed National Coverage Determination (“NCD”) thus would end the coverage with evidence development (CED) requirements for uses of FDG PET for initial diagnosis of these forms of cancer. In light of the data accumulated by NOPR, we concur that the CED coverage requirements should be lifted and Medicare coverage should be extended to the application of FDG PET to the initial diagnosis of these forms of cancer, without qualification. Under the Proposed NCD, the use of FDG PET in the subsequent treatment strategy of breast, cervix, colorectal, esophagus, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid cancers would be covered without evidence development. However, CMS proposes to cover the use of FDG PET in the subsequent treatment strategy of patients with brain, ovary, pancreas, prostate, small cell lung, soft tissue sarcoma, and testes cancers if the patient is enrolled in, and the FDG PET provider is participating in, a particular type of prospective clinical study.

We have several questions and concerns regarding the proposed coverage of FDG PET for subsequent patient management that would benefit from clarification and possibly revision by CMS:

First, we believe that the research data and existing literature supports full coverage for PET for all oncology indications in the category of therapy monitoring and follow up (“subsequent treatment”). Therefore, we ask that you amend the proposed decision to include “subsequent treatment” coverage for ovarian, pancreatic, small cell lung, soft tissue sarcoma, thyroid and testicular cancers, without further evidence development.

Second, if you decide not to amend the decision by including “subsequent treatment” coverage for these cancers, we are concerned about a potential gap in coverage for beneficiaries with these cancers. We understand that the NOPR is scheduled to end in April 2009, having served its intended purpose. Because no registry for the collection of data related to the subsequent treatment of ovary, pancreas, prostate, small cell lung, soft tissue sarcoma and testes cancers has yet been approved or implemented, we request that CMS clarify in the Proposed Decision how beneficiaries’ access to FDG PET will be maintained during the potential gap in registries.

Third, we believe that in certain clinical situations, the one-time-only availability of PET for “initial treatment” may compromise good clinical practice. In particular, the use of “initial treatment scan” PET data for the purpose of follow-on radiation therapy simulation and planning – these studies are technically performed in a different manner – may compromise planning accuracy. (E.g. The optimal therapy planning protocols should be performed using flat table top and in treatment patient position utilizing immobilization devices.)

Finally, we request that CMS give careful consideration to the appropriate endpoints to be used in future data collection activities. In the Proposed Decision, CMS identifies mortality as an outcome of greatest interest to the agency. We caution that evaluation of diagnostic and therapy planning technologies should focus on whether and to what extent the technology impacts treatment choices, (intermediate endpoints), and should not exclusively use endpoints that evaluate therapeutic success, such as mortality rate or QALYS.

We again applaud CMS for the care and deliberation underlying the proposed NCD and appreciate the opportunity to share our thoughts with the agency.

Respectfully submitted,

Eric Silfen, MD
Senior Vice-President and Chief Medical Officer
Philips Healthcare

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Steve Phurrough, MD, MPA
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid
7500 Security Blvd, Mail Stop
Baltimore, MD 21244 C1-09-06

Re: Proposed Decision Memo for Positron EmissionTomography (FDG) for Solid Tumors (CAG 00181R)

Dear Dr. Phurrough:

The Ovarian Cancer National Alliances writes toyou regarding the proposed decision memo forFDG-PET imaging (PET scans). The memo proposesallowing most cancer patients one PET scan forinitial diagnosis. This coverage decision must gofurther to aid women with ovarian cancer; such adecision would be supported by evidence. TheOvarian Cancer National Alliance supports theproposed omnibus cancer framework as a whole, butrespectfully requests that ovarian cancer, due tothe needs of patients and the strength ofevidence, be carved out and have additionalcoverage.

Overall, the National Oncologic PET Registry(NOPR) showed that one-third of scans led to achange in treatment. This intermediate measurefor patients is the appropriate measure forevaluating the effect of PET scans. It would beimpossible to measure the effect of PET on overallsurvival of a patient, due to the numerousintervening factors including skill of thesurgeon, treatment regimens, and other aspects ofpatient care.

For ovarian cancer patients, of more than 4,500who had PET scans through the NOPR, more than 40%had a change in treatment decision based on theresults of a PET scan. More than one-third ofwomen who were enrolled in NOPR had a change inmanagement from non treatment to treatment, and 7percent went from treatment to non treatment. Specifically, data from the NOPR supports whatwomen already know – that PET scans are incrediblyuseful for restaging and monitoring recurrence. Data from the NOPR shows that 43 percent of womengetting PET for staging, 37 percent getting PETfor restaging and 44 percent getting PET forrecurrence had a change in management. In fact,looking at the usage, it appears that PET forthese purposes was incredibly useful.

According to the American Cancer Society, 21,650American women were diagnosed with ovarian cancerin 2008 and 15,520 died from it. Ovarian canceris the deadliest gynecologic cancer and the fifthleading cause of cancer death among women inAmerica. There is no reliable early detectiontest for ovarian cancer, a tumor which seeds andspreads easily throughout the peritoneal cavity. It is often difficult to measure response totreatment, the spread of the disease and possiblerecurrences. While ovarian cancer is a lowincidence cancer, the NOPR has almost as manycases in the registry as prostate cancer. Fromthis data is it clear that doctors consider PET avery useful tool in monitoring ovarian cancerpatients. For these reasons, PET should be coveredby CMS.

We respectfully request that
- CMS cover PET for subsequent treatment for allcancers in the NOPR under an omnibus approach
- CMS cover PET for restaging and treatmentmonitoring for ovarian cancer as a carve out tothe omnibus approach
- Continue coverage of PET for ovarian cancerpatients under NOPR to ensure against a coverage gap

We appreciate the time and effort that CMS hasspent on this very important matter, as well asthe opportunity to comment. We look forward toworking with CMS to craft a coverage decision thatprovides the best and most appropriate care toovarian cancer patients.

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The national NOPR results of 33% for change in patient management was a very low percentage, that our site was surprised about. Our site was expecting a 70-80% in change in patient management from results from the NOPR PET scans. We did not enter prostate as an initial indication, which may have brought this (33%) nationale NOPR average down. Over utilization of imaging modalities is a concern for our patients, but our NOPR PET scan patients have told us that we are saving them costs of surgeries and follow-up tremenously.

If a CED is going to be implemented for subsequent scans of specific indications, I encourage another national consensus study amoung sites that utilized NOPR PET scans with the highest percentage with change in patient management. I encourage NOPR to use a consensus study.

I do agree with N/C of initial prostate cancer.

Sincerely, Bonnie Williams, CNMT
The Ohio State University Medical Center
CCC - The James
Nuclear Medicine Research Coordinator

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On behalf of Providence Health & Services (Providence), thank you for the opportunity to provide our comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed revision of the National Coverage Determination Manual that would replace the four-part diagnosis, staging, restaging, and monitoring response to treatment categories. The new framework would consist of two parts that differentiate FDG PET imaging used to inform the initial treatment strategy from other uses related to guiding subsequent treatment strategies after the completion of initial treatment. CMS posted their proposed decision memo on the CMS Web Site on January 6, 2009.

CMS is proposing to cover one FDG PET study for Medicare beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for certain therapeutic purposes related to the initial treatment strategy. CMS is also proposing to cover a subsequent FDG PET study for certain tumor types when the beneficiary’s treating physician determines that the FDG PET study is needed to inform the subsequent antitumor treatment strategy and the beneficiary is enrolled in, and the FDG PET provider is participating in, one of the specified prospective clinical studies.

Providence enthusiastically supports CMS’ proposed revision to their FDG PET NCDs. We feel that the proposed revision by CMS reflects the overwhelming evidence that FDG PET provides essential information for physicians treating oncology patients and results in improved clinical outcomes for beneficiaries. Providence applauds CMS for their willingness to review available literature and revise their NCDs to reflect current evidence on the beneficial use of FDG PET.

Providence also urges CMS to consider providing full coverage for the monitoring response to treatment category for all solid tumors as soon as possible using the NOPR data and other evidence as it becomes available. We believe that providing an early assessment via FDG PET of the efficacy of therapy reduces the cost and toxicity from providing ineffective therapy to Medicare beneficiaries. In addition, there should be no gap in coverage for subsequent treatment evaluations for cancers that are now covered under the NOPR and will continue to be covered only via a successor Coverage with Evidence Development (CED) program.

Providence would also like to take this opportunity to suggest that CMS review their coverage policies related to the use of F-18 PET and F-18 PET/CT for detection of bone metastases, specifically in patients with prostate, breast, or lung cancer. Several studies have been completed and others are in progress demonstrating that the use of 18-F PET and 18-F PET/CT are more sensitive than planar bone scans for detecting bone metastases and that clinical outcomes are significantly improved when using 18- F PET and 18-F PET/CT imaging compared with planar bone scans.* Providence supports a CMS NCD revision that would provide coverage for 18-F PET and 18-F PET/CT for detection of bone metastases, especially for patients with prostate, breast or lung cancer.

*See Even-Sapir, E. et al, “The Detection of Bone Metastases in Patients with High-Risk Prostate Cancer: 99m-Tc-MDP Planar Bone Scintigraphy, Single- and Multi-Field-of-View SPECT, 18-F- Fluoride PET, and 18-F-Fluoride PET/CT”; Schirrmeister, H. et al, “Early Detection and Accurate Description of Extent of Metastatic Bone Disease in Breast Cancer with Fluoride Ion and Positron Emission Tomography”; Hetzel, M. et al, “F-18 NaF PET for Detection of Bone Metastases in Lung Cancer: Accuracy, Cost- Effectiveness, and Impact on Patient Management”; and Even-Sapir, E. et al, “Assessment of Malignant Skeletal Disease: Initial Experience with 18-F-Fluoride PET/CT and Comparison Between 18-F-Fluoride PET and 18-F-Fluoride PET/CT.”

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February 5, 2009

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244

On behalf of the American Society of Clinical Oncology (ASCO), I am pleased to provide these comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed decision memorandum (CAG-00181R) involving the use of positron emission tomography (PET) for solid tumors.

ASCO is the leading medical society in the United States for physicians involved in providing clinical care to individuals with cancer and conducting research that leads to improved patient outcomes. We are committed to ensuring that evidence-based practices for the prevention, diagnosis and treatment of cancer are available to all Americans, including Medicare beneficiaries. We support continued access to PET scans for Medicare beneficiaries who have cancer and appreciate the opportunity to comment on CMS’ proposed policy.

ASCO participated in development of the National Oncologic PET Registry (NOPR) and was pleased to publish the initial results from NOPR in our flagship journal, the Journal of Clinical Oncology.¹ As you know, study results showed that for initial staging, PET altered the planned intervention in 36% of the cases. We understand this information, as well as other data, provided the basis upon which CMS has proposed coverage of PET as part of initial treatment planning. ASCO supports this proposal.

For all cancers except breast cancer, CMS proposes to cover PET scans used for subsequent scans only under the coverage with evidence development (CED) policy. This proposal is based on the agency’s determination that there is insufficient evidence to warrant coverage of these scans. However, we encourage CMS to review additional published data on PET such as the recent article in Cancer that shows information from PET scans conducted for treatment monitoring altered treatment decisions in 49% of cases.² This is clearly comparable to the level of change reported following initial staging scans. In light of these newly published data, it seems inconsistent to judge initial PET scans worthy of coverage, but restrict subsequent scans to the CED framework as proposed.

If CMS ultimately determines that subsequent scans will continue to be covered only under the CED policy, then it is imperative that the final provisions are implemented in a manner that assures continuity of care—as well as coverage—for patients. Patient access to PET scans should be maintained throughout the transition to any new CED framework.

ASCO has serious concerns with the proposed provision that would impose thirteen criteria clinical trials involving PET. ASCO objects to imposition of these criteria and strongly recommends their deletion from this coverage policy. CMS proposed these same criteria in 2007 as part of its consideration of a new national coverage determination for all clinical trials. Based on comments received from the public, the agency excluded these provisions from its final policy (see Decision Memorandum for Clinical Trial Policy, CAG-00071R2). The rationale for their inclusion in the proposed coverage for PET scans is unclear.

We have attached the comments ASCO submitted in 2007 in response to the second reconsideration of the clinical trials policy (CAG-00071R2). Many other organizations submitted similar comments. The criteria are overwhelmingly subjective, are duplicative of many existing rules and regulations, and represent significant administrative burden. In short, they are unworkable in practice. Our earlier comments warned that adoption of these criteria would have an adverse impact on accrual of seniors to cancer clinical trials. Their inclusion in this proposed policy would, likewise, represent an unnecessary and adverse impact on accrual of Medicare beneficiaries to clinical trials involving CED for PET scans. We commend CMS for withdrawing the proposed 13 criteria from the national policy on clinical trials in 2007, and we strongly urge CMS to refrain from using these same criteria within the PET scan policy or any other CED policy.

We value our longstanding and collaborative relationship with CMS, and we hope that you and your colleagues at CMS and other federal agencies will continue to rely on ASCO as a resource for issues involving the interpretation of scientific data and the standards of clinical practice for preventing, diagnosing and treating cancer. Please contact Deborah Kamin, Ph.D., Senior Director of Cancer Policy and Clinical Affairs, at (571) 483-1610 or deborah.kamin@asco.org with questions or requests for information.

Sincerely,

Allen S. Lichter, MD
Chief Executive Officer

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February 5, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Phurrough,

The Pancreatic Cancer Action Network thanks the Centers for Medicare & Medicaid Services (CMS) for the oppottunity to comment on the draft decision memorandum on Medicare coverage of Positron Emission Tomography (PET) for cancer.

The draft decision memo proposes the following:

1. Replacing the four-part diagnosis, staging, restaging, and monitoring response to treatment categories with a two-part framework that differentiates FOG PET imaging used to inform the initial treatment strategy from other uses related to guiding subsequent treatment strategies;
2. Lifting the Coverage with Evidence Development (CEO) requirements and allowing Medicare to provide reimbursement coverage of one PET study to guide the "initial treatment strategy" for cancer patients with a confirmed or strongly suspected diagnosis of solid-tumor cancer, including pancreatic cancer; and
3. Limiting coverage of a subsequent FOG PET study for most tumor types, including pancreatic cancer, to Medicare beneficiaries who are enrolled in the National Oncologic PET Registry (NOPR).

While we strongly support the decision to provide Medicare coverage of PET scans used in initial treatment for pancreatic cancer patients, we have some concerns aboLtt the decision to limit coverage of subsequent PET studies for pancreatic and other cancers to those who are enrolled in the registry.

Pancreatic cancer is one of the most deadly cancers. Over 37,000 Americans are diagnosed with pancreatic cancer each year. Because there are currently no standard early detection tools or effective treatments, 75% of patients die within the first year of diagnosis and 95% die within live years.

One of the most important indicators in pancreatic cancer treatment is determining whether patients are eligible for surgical resection of their tumors, as surgery represents the best chance for survival. PET is an important tool in this process to both detenni ne whether the patient is a surgical candidate at the time of initial diagnosis, and also to assess tumor responsiveness to treatment and determine whether surgery is possible as subsequent treatment. Other ways that PET scans are used in pancreatic cancer treatment include: differentiating a benign or chronic pancreatic mass from a malignant tumor, pre-operatively locating a pancreatic mass, and identifying potential metastases to the liver or elsewhere.

The NOPR data was fairly consistent for pancreatic cancer patients for both initial staging and subsequent treatment. According to the NOPR data, 39.2% of pancreatic cancer cases had an intended change in management when PET was perfomled for initial staging, indicating that the physician intended to make a change in care based on the results of the PET scan. Among pancreatic cancer patients who had a PET for restaging, the physician intended a change in management in 38.3% of the cases. The percentage was similar for PET performed for detection of a suspected recurrence in pancreatic cancer patients - the physician intended a change in management in 39.3% of the cases.

It is important to note the high number of pancreatic cancer patients included in the NOPR registry: pancreatic cancer patients represented the third largest group and 9% of the patients in the registry. We believe that the high numbers are due at least in part to the fact that PET represents one of the very few diagnostic and assessment tools available to physicians treating pancreatic cancer patients.

While we appreciate that the proposed coverage decision would allow Medicare coverage of PET scans for subsequent treatment for pancreatic cancer patients as long as they are enrolled in the NOPR, we believe that the NOPR data has already shown that PET is an important tool in monitoring the treatment of pancreatic cancer. Further, the above mentioned data show relative consistency in physicians' intention to change management based on PET used at various points in pancreatic cancer diagnosis and treatment. It makes sense to offer patients consistent coverage, particularly when so few diagnostic modalities exist. Given that there are few other diagnostic options currently available to pancreatic cancer, which is the fourth leading cause of cancer-related death, we urge you to reconsider your proposed decision and to provide full coverage, without CED requirements, for pancreatic cancer.

We are also concerned about the potential for interruption in coverage of PET for subsequent treatment strategies after the finalization of the National Coverage Decision (NCD). We strongly encourage you to transition to a new CED framework immediately after finalization of the NCD to allow patients seamless, timely access to PET.

We appreciate the opportunity to comment on the draft decision memo and would be pleased to provide CMS with any additional informat ion. Should you have any questions, please feel free to contact me at 202.742.6776 or mgdon@pancan.orll. On behalf of the Pancreatic Cancer Action Network, we look forward to the final NCD and thank you for consideration of our comments and concerns.

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September 19, 2012

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid
7500 Security Blvd., Mail Stop C1-09-06
Baltimore, MD 21244

Re: Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG 00181R)

Dear Dr. Phurrough:

On behalf of the Council on Radionuclides and Radiopharmaceuticals (CORAR), we are pleased to submit comments to the Centers for Medicare & Medicaid Services' (CMS), Coverage and Analysis Group, on its proposed decision memorandum revising the current Medicare national coverage determination (NCD) for oncologic FDG-PET imaging. CORAR represents the developers, manufacturers, and radiopharmacies that provide radiopharmaceuticals to hospitals for the diagnosis and treatment of Medicare and other patients. Over the past several years, CORAR has worked closely with CMS on issues involving PET to increase beneficiary access.

CORAR also supports the efforts of the National Oncologic PET Registry (NOPR) Investigators, the American College of Radiology (ACR), the Academy of Molecular Imaging (AMI) and others to increase beneficiary access to PET/CT through the development of the NOPR Registry. In brief, our comments are as follows:

• CORAR strongly supports CMS's proposed decision to streamline and simplify the coverage framework by distinguishing "initial" treatment from "subsequent" treatment and eliminating the previous four-category framework.
• We applaud and approve of CMS's decision to provide expanded coverage for "initial" treatment for almost all oncologic indications.
• We recommend, based on the overwhelming level of evidence, that CMS further expand coverage in the final decision to include "full coverage for PET for all oncologic indications under the category of "subsequent" treatment.
• We recommend that CMS clarify and add multiple myeloma as a "solid tumor" for purposes of this NCD.
• We strongly encourage CMS to take all necessary steps to ensure that beneficiaries have continued and continuous access to PET if the final NCD does continue CED (Coverage with Evidence Development) reporting for certain cancers. We are concerned that there may be a delay in setting up new CED studies, and it is crucial to ensure that patients are not harmed by delays in access.
• We also ask that CMS cover clinically-appropriate "second" initial scans when a patient requires more than one PET study for initial staging. We understand that the current NOPR data suggests that such a situation is likely to occur less than two percent of the time.

In closing, we support the new framework that CMS has proposed, and we believe that adoption of the recommendations listed above will further enhance the proposed coverage decision and ensure that patients have meaningful access to PET.

We appreciate the opportunity to provide these comments and look forward to continuing our work with CMS.

Sincerely,

Michael Guastella
Co-Chair, CORAR Health Policy Committee

Fred Longenecker
Co-Chair, CORAR Health Policy Committee

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February 5, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD  21244

Re:      Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R)

Dear Dr. Phurrough:

The Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), appreciates this opportunity to comment on the Center for Medicare and Medicaid Services’(CMS) Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R) (the “Proposed Decision”). [1] As the leading trade association representing companies whose sales comprise over ninety five percent of the global market for medical imaging and radiotherapy, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides.  MITA looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases. 

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, radiation therapy, related image acquisitions, diagnostic ultrasound, and nuclear medical imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI).  Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures.[2]   In addition, medical imaging equipment often is used to select, guide and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.[3]  MITA’s members also develop and manufacture innovative radiotherapy equipment used in cancer treatment.

In the Proposed Decision, CMS announces that it will replace the “four-part diagnosis, staging, restaging, and monitoring response to treatment categories” under the current national coverage determination (NCD) with a “two-part framework that differentiates FDG[4] PET imaging used to inform the initial treatment strategy from other uses related to guiding subsequent treatment strategies after completion of initial treatment.”[5] Under this new framework, Medicare would cover one FDG PET study without evidence development for “beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor” during the initial treatment strategy.[6]  CMS proposes to cover the use of FDG PET in the subsequent treatment strategy of patients with brain, ovary, pancreas, prostate, small cell lung, soft tissue sarcoma, and testes cancers if the patient is enrolled in, and the FDG PET provider is participating in, a particular type of prospective clinical study.  The use of FDG PET in the subsequent treatment strategy of breast, cervix, colorectal, esophagus, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid cancers would be covered without evidence development.

MITA is pleased that CMS proposes to expand coverage for certain uses of FDG PET.  This decision would end the coverage with evidence development (CED) requirements for uses of FDG PET in the initial treatment of many types of cancers and will improve patient access to this important procedure.  This decision is supported by the evidence cited in the Proposed Decision, including the data gathered by the National Oncologic FDG PET Registry (NOPR) that was created to collect data under the current NCD.  As CMS notes in the Proposed Decision, the NOPR data on 22,975 patients indicate that physicians changed their intended management in 36.5 percent of cases after FDG PET was performed.[7]  The NOPR data and the other studies in the current evidence base for FDG PET “consistently note the physicians’ use of FDG PET imaging results to guide management for several cancer indications.”[8]  Now that CMS’s CED policy for FDG PET has accomplished its goal of collecting data for use in Medicare coverage decisions, and the data demonstrate that the technology has a dramatic effect on the treatment received by Medicare beneficiaries battling cancer, we agree that the CED requirements should be lifted for these uses of FDG PET.

Although MITA supports CMS’s proposal to expand coverage for FDG PET, we ask CMS to address the following issues in the final decision memorandum to ensure that beneficiaries can receive this important service.  First, we ask CMS to cover more than one FDG PET study without evidence development for patients whose initial treatment strategy includes radiation therapy planning.  Radiation therapy planning is the process of determining the most effective manner to deliver radiation therapy.  It often involves the use of a PET scan of a limited area of the patient’s body taken with the patient in a different position than is used for a staging study.  The therapy planning scan clearly is part of the “initial treatment strategy” because it must be performed before radiation therapy can be delivered, but under the Proposed Decision, these scans would not be covered for patients who already received another scan.  We urge CMS to clarify in the final decision that a second FDG PET study will be covered as part of the initial treatment strategy for patients who require radiation therapy.  

Second, we ask CMS to re-evaluate the evidence on use of FDG PET for ovarian cancer.  The data cited in the Proposed Decision, including the Technology Assessment and NOPR data, support a conclusion that FDG PET is beneficial for subsequent treatment of ovarian cancer.  CMS should expand coverage for this use of FDG PET based on these data.

Third, we ask CMS to state that it will use the full set of NOPR data to reconsider coverage for FDG PET in the subsequent treatment strategy for patients with tumor types other than breast, cervix, colorectal, esophagus, head and neck (non-central nervous system/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid.  In the Proposed Decision, CMS notes that it anticipates that the agency will reconsider this NCD if studies performed under CED provide sufficient evidence for coverage without evidence development.[9]  Since the NOPR study cited in the Proposed Decision was published, the registry has continued to collect data that we expect will be useful in a future coverage determination, particularly on the use of FDG PET for treatment monitoring.  We hope that CMS will review these data when they are available and lift the remaining CED requirements at the earliest possible date.

Fourth, for the uses that remain subject to CED, we ask the agency to clarify how it will maintain continuous coverage in light of the planned end of the NOPR registry in April 2009.  CMS proposes to cover these uses when the patient is enrolled in, and the provider is participating in, (1) a clinical trial of FDG PET that meets the requirements of the Food and Drug Administration category B investigational device exemption or (2) a clinical study that is designed to collect additional information at the time of the scan to assist in patient management.  Because CMS does not describe the process it will use to determine if a study meets the requirements of the second option, is possible that CMS will not identify any qualifying studies before the effective date of the final coverage determination.  If there is a gap between the effective date of the final decision and the availability of such a study, Medicare beneficiaries may be denied access to beneficial FDG PET services.  We urge CMS to clarify in the final decision how it will ensure that beneficiaries’ access to these services is not impaired by any gaps between the current and final NCDs.

Finally, we ask CMS to ensure that any studies used for coverage of FDG PET use appropriate, diagnostic endpoints.  CMS proposes to require studies of FDG PET to adhere to “standards of scientific integrity and relevance to the Medicare population,” including a requirement that the “principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.”[10]  In the Proposed Decision, CMS identifies “surgical procedures, including biopsies; anticancer chemotherapy; radiotherapy; hospitalization; and mortality”[11] as outcomes of greatest interest to the agency.  Studies of diagnostic technologies should evaluate whether the technology impacts treatment choices, and should not necessarily use the types of endpoints that are used to evaluate therapeutic interventions, such as mortality.  We recommend that CMS focus on outcomes directly related to changes in patient management, such as the decision to provide radiation or chemotherapy, to perform a surgical procedure, or to offer palliative care.

We appreciate this opportunity to submit these comments and applaud CMS for this successful application of CED to expand Medicare beneficiaries’ access to clinically effective care.  If you have any questions or would like to discuss these matters further, please contact me at 703-483-5495.  Thank you for consideration of these comments.

Respectfully submitted,

Ilyse Schuman

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February 5, 2009

Steve Phurrough, MD, MPA
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid
7500 Security Blvd, Mail Stop
Baltimore, MD 21244 C1-09-06

Dear Dr. Phurrough:

GE Healthcare (GEHC) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum revising the current coverage determinations for oncologic FDG-PET imaging.

GEHC, a $17 billion unit of General Electric Company with headquarters in the United Kingdom, has expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceuticals manufacturing technologies. GEHC’s broad range of products and services enables healthcare providers to offer patients earlier and better diagnosis and treatment of cancer, heart disease, neurological diseases, and other conditions to improve the quality and length of life. Worldwide, GEHC employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

Overall, we recognize and applaud the early success of the CMS Coverage with Evidence Development (CED) approach within the National Coverage Determination (NCD) process. In particular, results of the data collection achieved through a Coverage with Study Participation (CSP) methodology should improve patient care and physician decision making while speeding access to innovative, beneficial technologies.

GEHC fully supports the collaborative response submitted jointly on behalf of the National Oncologic PET Registry (NOPR) Investigators, the American College of Radiology (ACR), the Academy of Molecular Imaging (AMI), the American Society for Therapeutic Radiology and Oncology (ASTRO), and the Society of Nuclear Medicine (SNM). Collectively, clinicians, academicians, researchers and nuclear medicine providers coordinated their feedback and we would like to acknowledge their efforts to unify responses from the various stakeholders for optimal oncology patient care. Thus, GEHC believes these key points from their collaborative joint response are important to reinforce for future CMS policy:

• Overall support for the proposed FDG-PET decisions and streamlined coverage framework with ‘initial’ and ‘subsequent’ treatment that may be less administratively burdensome
• Coverage for initial treatment for nearly all oncologic indications that were covered previously under CED
• Coverage for nine oncologic indications that were covered under prior individual CMS decisions
• Allow second, ‘initial’ PET scan for radiation therapy planning purposes when clinically necessary

While we applaud the proposed decision in general, we do have concerns regarding the study requirements that would benefit from clarification and revision by CMS in its final decision.

As noted above, CMS determined that evidence is sufficient to determine that FDG PET imaging for subsequent anti-tumor treatment strategy is reasonable and necessary within the context of Coverage with Evidence Development/Coverage with Study Participation. CMS states that proposed studies would be designed to collect additional information at the time of the scan to assist in patient management. We would like to raise three concerns.

First, we ask CMS to ensure that any studies used for coverage of FDG PET use appropriate, well-defined diagnostic endpoints. Studies of diagnostic imaging technologies should evaluate whether the technology impacts treatment decision and choices, and should not necessarily use outcome endpoints often used to evaluate therapeutic interventions. We recommend that CMS focus on outcome endpoints directly related to changes in patient management for the resolution of diagnostic dilemmas, such as the clinical decision to provide radiation or chemotherapy, to perform a surgical procedure, or offer palliative care. FDG-PET imaging provides crucial additional information in the evaluation of cancer patients that very often alters patient management in ways already known to improve therapeutic outcomes by enabling better choice of therapy appropriate to the patient’s stage of disease.

Second, if the final decision elects to continue CED for certain cancers and indications, we are concerned that the proposed memorandum does not adequately address the practical issue of ensuring that beneficiaries continue receiving uninterrupted access to PET during the transition from the existing NCD framework to the new NCD. We do not believe that it would be beneficial to continue data collection indefinitely under the NOPR in its current design. We support continued collection of data on the impact of PET on diagnostic outcomes such as patient management as long as it does not result in a coverage gap. Thus, we propose CMS utilize the existing NOPR protocol to enable beneficiaries to continue receiving PET coverage under a transitional study vehicle while a diagnostic outcomes study is being finalized.

Finally, it is imperative that any follow-on diagnostic outcome study to NOPR be constructed using a transparent, multi-stakeholder process that allows adequate time for public review and feedback. In the case of registries, transparency contributes to public and professional confidence in the scientific integrity and validity of registry processes. Public information about operations of a registry may enhance the utility of registry data by promoting further analysis of registry data. Transparency can be achieved by making the registry’s scientific objectives, governance, eligibility criteria, sampling and recruitment strategies, general operating protocol and sources of data available to stakeholders.

GEHC reiterates its support for the new CMS framework and expresses its appreciation for the efforts CMS has made to expand oncologic PET coverage to Medicare beneficiaries. We appreciate the opportunity to comment on this proposed decision memorandum, and look forward to providing CMS with any additional information that would be of value in this regard.

Sincerely,

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To Whom it May Concern,

I have recently learned about the proposed changes in Medicare coverage for PET/CT scans. I am pleased that CMS has recognized the significant contribution of PET/CT for appropriately staging patients at the onset of treatment. I feel strongly that this decision to expand coverage to all solid tumor types will allow surgeons to better evaluate our cancer patients by clarifying the extent of disease and identifying the most appropriate surgical candidates. The anatomic and metabolic information with this integrated scan helps to accurately define local tumor extension and regional lymph node involvement, two factors that are important for planning my surgical approach. For more advanced cases, there are times when conventional imaging examinations grossly underestimate the true extent of disease. Taking these patients to surgery only to find that the disease has spread beyond what is manageable is frustrating for the surgeon and extremely disheartening for the patient. As a whole-body examination the PET/CT scan offers a more accurate and complete picture of the patient's disease prior to the surgery.

The one area that I feel may still need to be expanded is in the subsequent treatment setting, either following neoadjuvant chemoradiation or for the detection of recurrence. For neoadjuvant therapy assessment, it is important for me to know whether the disease has improved, remained stable or progressed during this time imterval prior to initiation of surgery. PET/CT has been proven to identify a response to therapy or lack thereof at an earlier time frame than conventional imaging since metabolic changes precede anatomic changes. Following surgery, the anatomy is altered significantly thus rendering anatomic imaging of the area less effective. That being the case, I would like to have the opportunity to evaluate patients with signs and symptoms of a recurrence with PET/CT to determine if there is recurrent disease at the surgical site, and, with the same scan, evaluate for additional regional or distant metastatic disease.

I recognize that we are in the era of identifying ways to save healthcare dollars, but I feel strongly that PET/CT, through a replacement of other less effective imaging modalities and selection of the best treatment options for patients, will prove to be cost effective and will likely have a significant impact on patient outcomes.

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PETICT scans. I firmly agree that the coverage of PETICT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PETICT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PETICT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PETICT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the aVOidance of surgeries and other localized treatments that would have proven ~utile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PETICT, pursuing localized treatments only to find out that such coursesiof action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PETICT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PETICT t,requently replaces multiple imaging modalities, saving my patients time, radiation expQsure, costs and'inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PETICT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PETICT scaAS in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PETICT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PETICT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PETICT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PETICT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andlor whether they are relapsing. The information provided by PETICT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PETICT coverage for the subsequent treatment period as well.

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February 5, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage decision (NCD), Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
We support CMS's intent to ensure that all patients receive the most effective and appropriate treatments as indicated by sufficient levels of clinical evidence. AHIP supports the proposed decision to maintain the current levels of coverage for the three exceptions noted within the decision memorandum: non-coverage of PET for initial anti-tumor treatment strategy for adenocarcinoma of the prostate, continuing to cover the initial treatment strategy for male and female breast cancer only when used in staging distant metastasis and not providing coverage for the imaging for diagnosis and initial staging of axillary nodes, and, non-coverage of PET FDG for the evaluation of regional lymph nodes in melanoma.

However, AHIP has concerns with CMS's proposed decision to remove the Coverage with Evidence Development (CED) data collection requirements currently in place for most solid tumor indications, provide coverage of PET across all oncologic indications for the proposed "initial treatment" indication (currently "diagnosis" and "staging"), and roll the current NCDs for all solid tumors into one omnibus NCD. While we support strengthening the CED coverage requirement for the proposed "subsequent treatment" indication (currently "restaging" and "monitoring response to treatment when a change in treatment is anticipated") to CED Coverage with Study Participation (CSP), we have concerns regarding the solid tumors which are proposed to receive full coverage without CSP requirements for the "monitoring" indication (breast (female and male), cervix, colorectal, esophagus, head & neck (not thyroid or central nervous system), lymphoma, melanoma, and non-small cell lung).

At this point in time, the available evidence strongly suggests that PET FDG for solid tumors has the ability to differentiate metabolism of normal and abnormal tissues and that the results of this testing can influence treatment options, with a rapid pace of new data emerging for this technology. It is not clear, however, that PET has the diagnostic accuracy for all tumors, as there are frequent technical challenges in obtaining a precise result with some malignancies, or that the changes in treatment based on this imaging result in improved patient outcomes. CMS's own Medicare Evidence Development & Coverage Advisory Committee (MedCAC) came to these same conclusions at their August 2008 meeting, which focused on this technology.

On August 20, 2008, MedCAC met to discuss the evidence, hear presentations and public comment, and make recommendations concerning the oncologic indications of FDG Positron Emission Tomography (PET), for nine cancers: brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney. After reviewing the evidence, the committee was asked how confident they were that the evidence shows that FDG-PET imaging improves physician decision making when used for the diagnosis, staging, restaging and monitoring of the solid tumors. Within both the diagnosis and staging categories for the nine tumors under review, no committee member voted a "moderate confidence" or above, for any of the nine tumors. For the restaging and monitoring categories, the average vote was "moderate confidence" for only two cancer types out of nine (cervix and ovarian). Yet, CMS is proposing to remove the current CED requirements for all tumors with the three noted exceptions above. AHIP requests clarification from CMS on why the proposed decision for the use of PET for initial treatment does not follow the recommendations of the CMS committee charged with reviewing available evidence and advising CMS on coverage decisions.

• The request for reconsideration of coverage was based on data from the clinician survey sponsored by the National Oncology PET Registry's (NOPR's) Working Group. The letter received from the NOPR Working Group presents data on clinicians' perceived change in management based on PET results. These data, however, are aggregated for all types of cancer. CMS should request that the NOPR Working Group provide data separately for each cancer type as PET may impact the management of one type of cancer differently than another.

  For example, currently there is wide agreement that PET is inappropriate for the surveillance of any cancer, yet the term "restaging" is often used when the actual clinical situation is "surveillance." This issue could potentially be addressed by refining the descriptions of the five clinical situations and ensuring that precise ICD-9 codes (and any other appropriate code sets) are provided within the NCD that can accurately reflect each of the clinical settings within the CED mechanism, as associated with the type of solid tumor.

• Unlike prior CMS coverage with evidence development (CED) decisions, it does not appear that NOPR validated, beyond self-reported data, a change in treatment or patient management; nor that any change resulted in actual benefit or improved outcomes to the patient. Unfortunately, evidence on perceived change in clinical management is open to many biases, including the potential to help guide future coverage decision-making.

  CED efforts should not only provide better evidence to assess which treatment options align with the evidence, but also help achieve improved patient outcomes. This information will help clinicians and consumers to assess whether the addition of new diagnostic tests provides a net health benefit for patients.

Health plan data suggests significant inappropriate use and over-utilization of PET within the oncology setting; a blanket expansion of coverage without collecting and analyzing the appropriate evidence has the potential to exacerbate this problem. This is especially a concern when the technology in question (diagnostics) has a history of fast adoption by clinicians, which can amplify the effects of inappropriate use, resulting in potential patient harm. As such, AHIP strongly recommends that CMS maintain the CED data collection requirement for PET FDG for the proposed "initial treatment" stage (currently "diagnosis" and "staging") for all cancer types (minus the exclusions noted above) as current evidence does not show that PET is effective in helping to determine the appropriate, curative treatment for the cancer.

Additional Recommendations for Continued Evidence Development
In addition, our members would like to reiterate the following recommendations for CMS to enhance the data collection efforts and the development of new evidence that will improve the ability of providers and patients to make more informed health care decisions and thereby, achieve improved patient outcomes.

• It would be beneficial to CMS to perform or commission (through NOPR or another appropriate entity) a comparative analysis of the clinical information derived from the registered PET studies and other imaging studies or tests which may have been performed in absence of a PET scan. This type of comparative information could further help physicians determine the appropriateness of using PET FDG as compared to standard imaging practices for these populations.

• Within the requirements for CED for these indications, CMS should routinely audit a sample number of cases to independently confirm and evaluate the outcomes of cases reported to be positive for "significant" changes, or any similar analysis to verify the actual impact that PET has had on clinical outcomes.

Within this proposed decision, CMS requested feedback on whether or not the current coverage framework for PET FDG for solid tumors, which required cancer-by-cancer consideration of diagnosis, staging, restaging, and monitoring response to treatment, should be replaced with their proposed omnibus coverage consideration. AHIP would only support the development of an omnibus national coverage decision if CMS continued to review the evidence for each cancer type with concern for the myriad pathophysiological differences between types and stages of cancers and patient outcomes. AHIP has concerns that a blanket authorization of coverage for all oncologic indications, without an appropriate and timely review of the evidence, will contribute to over-utilization and inappropriate use of PET. It is important to have reliable evidence regarding each cancer type to determine whether the use of this technology improves both clinical treatment decisions and patient outcomes.

Thank you for the opportunity to provide comments on this issue.

Sincerely,

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To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent ofthe disease and determining an appropriate course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction. However, from my perspective, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans by the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is Vitally important that I am able to order a PET/CT scan in the treatment planning position- the same exact position in which the patient will receive daily treatments. Some ofthese patients may have undergone surgery and/or chemotherapy since their initial scan. A PET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior) provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.

2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et al 2003). In my practice, I have seen patients with cancers Which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.

3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post- therapy changes are very difficult to differentiate from active disease on a CT alone; however, PET/CT allows me to do just that. I cannot use an inferior imaging modality which will often be indeterminate to decide whether or not my patients require salvage treatments which may impact their overall survival. One ofthe key advantages of PET/CT is the ability to assess residual or recurrent disease 2-3 months sooner than conventional imaging. For a patient with cancer, this time is crucial.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but I am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

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From 2001 - 2006, I sold PET and PET/CT systems to hospitals and oncology centers. I'm aware that CMS has used a deliberate process in approving reimbursement of PET imaging, balancing the clinical benefit and the cost. This all became very personal for me last year (2008). [PHI Redacted] started having abdominal pain last Spring. He was 70 years old, retired, and under Medicare health insurance. His physician proceeded with a series of diagnostic tests including Ultrasound, X-rays and CT, but nothing was found. The effectiveness of the CT was hindered by his artificial hip (blurriness from the scattered x-rays). By early October, they did a biopsy of a blockage between his right kidney and bladder. The biopsy results were normal. Their next step was to schedule surgery on November 19th to remove the blockage. Upon opening [PHI Redacted] abdomen, the surgeon found cancer all over. The ureter blockage was due to a tumor that was squeezing the ureter shut from the outside, thus explaining why the biopsy was normal (healthy tissue was obtained from the inside of the ureter, not the tumor outside of the ureter). The surgeon deemed it to be Stage IV cancer and proceeded to sew the abdomen shut. He referred [PHI Redacted] to an oncologist who ordered a PET scan to confirm the cancer and determine the source. The PET scan was taken on December 8th, and the diagnosis was Gall Bladder cancer. [PHI Redacted] was told he would live 3-4 months, but if he chose to undergo chemotherapy, there was a 50/50 chance he would live a year. [PHI Redacted] decided to do the chemotherapy, but died on Saturday, December 27th, two days before the treatment was to start. I'm convinced that if the PET scan would have been reimbursable for the initial diagnosis, it is likely an accurate diagnosis would have been obtained last Summer, and [PHI Redacted]'s course of treatment and chances of survival would have been much higher. Plus, many unnecessary expensive procedures would have been avoided. Please make PET reimbursable as the initial diagnostic test. The clinical data supporting it is overwhelming, costs will be reduced, and patients & their families will benefit from having an accurate diagnosis much earlier in the process. Thank you.

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

Less

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andtor whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

Less

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT. MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by Whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatrnent setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the Subsequent treatment period as well.

Less

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PETICT scans. I firmly agree that the coverage of PETICT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PETICT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PETICT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PETICT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the aVOidance of surgeries and other localized treatments that would have proven ~utile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PETICT, pursuing localized treatments only to find out that such coursesiof action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PETICT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PETICT t,requently replaces multiple imaging modalities, saving my patients time, radiation expQsure, costs and'inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PETICT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PETICT scaAS in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PETICT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PETICT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PETICT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PETICT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andlor whether they are relapsing. The information provided by PETICT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PETICT coverage for the subsequent treatment period as well.

Less

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andtor whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

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Dear CMS Administrators,

I am writing to express my gratitude that expansion of coverage for PET FDG in medical oncology is occurring and express concern that we have limitations in the clinical use of PET FDG in breast cancer. I am a practicing medical oncologist, a breast researcher and an Associate Professor, at an academic institution (University of Washington, Seattle Cancer Care Alliance, Fred Hutchison Cancer Research Center, and Harborview Medical Center). As we know PET FDG is a standard part of the work-up ("staging") of breast cancer. As per NCCN guidelines, this is not appropriate for very early stage tumors, but extremely useful in advanced tumors, especially to examine nodal metastasis, including supraclavicular and internal mammary nodes as shown by our group (Bellon, et alAm J Clin Onc 04, Yao, M M Ann Surg Onc 07). The other site of metastasis for which PET is particularly useful in assessing disease is bone (Stafford et al 02, Specht, JM et al 07).

Hence we use PET FDG to assess disease activity in bone and lymph nodes, but this use is not limited to initial staging. In appropriately selected patients we use PET FDG to follow disease activity in these sites, and for radiation treatment planning. In my practice I do not use PET FDG to image every patient, but select them for particular studies based on the situation. I am frustrated that a patient with lytic bone metastasis could have an infinite number of MRI or bone scans, yet I could eliminate the use of both with the ability to use serial PET FDG which could stage the whole body, and assess response in the bone lesions.

I hope that the current oncologic situations which are covered for PET FDG can remain available and that we can obtain expanded coverage to assess response in nodes and bone.

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Dear Sirs-

As a Nuclear Physician that utilizes this PET/CT imaging technique daily, I think I can speak to the efficacy of PET in managing the cancers listed in the document. PET should have broader coverage to include these types listed as well as others.

We think that if utilized appropriately PET can provide cost savings by upgrading staging, thereby reducing unneccesary surgeries, and other diagnostic tests. More appropriate diagnostic initial staging and restaging can be done with PET. The literiture supports this.

Respectfully Submitted-

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT. MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by Whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatrnent setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the Subsequent treatment period as well.

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1. Should the current framework for evaluating the use of FDG PET imaging be modified as proposed?

Yes, but even better to expand coverage for both initial treatment evaluation and subsequent treatment evaluation for all cancers, thus giving physicians the same latitude in use of PET that they have with CT and MRI.
2. Does the evidence support the broad expansion of coverage of FDG PET imaging to all solid tumors when determining initial treatment strategy?

Yes.
3. Does the evidence support the restriction of coverage of FDG PET imaging in solid tumors when determining subsequent treatment strategy to coverage with evidence development?
4. No.
5. For breast cancer and melanoma that have noncoverage for initial treatment strategy, is there evidence that would support their removal from the list of exceptions to coverage for initial treatment strategy?

Not at this time.
6. For the nine cancers that have coverage for subsequent treatment strategy, is there evidence that would support restricting their coverage to CED?

No.
7. The program should ensure that PET can still be used practically for radiation therapy planning (which could be a problem with the one scan per cancer diagnosis limit for initial treatment evaluation). This enables the use very focal high dose tumor treatment with reduction in damage to normal tissues.
8. There is concerns over roll-back in coverage for subsequent treatment evaluation uses of PET for the currently covered cancers. These have shown to be very helpful to determine the benefits or lack there of with w specific treatment regimen.
9. The potential gap in coverage for subsequent treatment evaluation for cancers that are now covered under NOPR, would continue to be covered only via CED until a successor CED program can be implemented. This is of concern for those patients whose treatment is dependent on the guides lines provided by FDG PET.
10. The evidence provided to CMS by the NOPR and in the technology assessment commissioned by CMS clearly suggests that ovarian cancer, at a minimum, should be covered.

Patrick J. Perkins, MD

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To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent of the disease and determining an appropriate course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction. However, from my perspective, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans by the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is vitally important that I am able to order a PET/CT scan in the treatment planning position- the same exact position in which the patient will receive daily treatments. Some of these patients may have undergone surgery and/or chemotherapy since their initial scan. A PET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.
2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et al (2003). In my practice, I have seen patients with cancers which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.
3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post-therapy changes are very difficult to differentiate from active disease on a CT alone; however, PET/CT allows me to do just that. I cannot use an inferior imaging modality which will often be indeterminate to decide whether or not my patients require salvage treatments which may impact their overall survival. One of the key advantages of PET/CT is the ability to assess residual or recurrent disease 2-3 months sooner than conventional imaging. For a patient with cancer, this time is crucial.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but I am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

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To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent of the disease and determining an appropriate course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction. However, from my perspective, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans by the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is vitally important that I am able to order a PET/CT scan in the treatment planning position - the same exact position in which the patient will receive daily treatments. Some of these patients may have undergone surgery and/or chemotherapy since their initial scan. A PET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior) provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.
2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et at 2003). In my practice, I have seen patients with cancers which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.
3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post-therapy changes are very difficult to differentiate from active disease on a CT alone; however PET/CT allows me to do just that. I cannot use an inferior imaging modality which will often be indeterminate to decide whether or not my patients require salvage treatments which may impact their overall survival. One of the key advantages of PET/CT is the ability to assess residual or recurrent disease 2~3 months sooner than conventional imaging. For a patient with cancer, this time is crucial.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but l am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PETICT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

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As a surgeon who cares for oncologic patients, the evolving use of PET and especially PET-CT has added an extraordinary new diagnostic dimension to my ability to care for patients with cancers in a variety of organ systems.

We are long since beyond the time when PET started as a novel way to image patients with solid organ tissue tumors. PET and PET-CT techniques have become vitally important to the accurate diagnosis, staging, restaging, and long term monitoring of oncologic patients. There are innumerable reports in the medical literature how accurate staging with PET and PET-CT is changing treatment decisions due to the greater accuracy of this diagnostic modality. There are now an increasing number of treatment algorithms for how to use this technology. PET and PET-CT clearly plays a role in the development of Best Practice Guidelines and Clinical Pathways as we care for our oncologic patients.

I am strongly supportive of a new general policy statement on the use of PET and PET-CT to replace the existing cancer by cancer consideration coverage framework. This should also save the U.S. Health Care System money by streamlining the process to obtain timely care for our oncologic patients.

Thank you for your time and interest as you address this important policy decision.

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PETICT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

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To Whom It May Concern:

Thank you for receiving my feedback regarding the proposed expansions of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized testaments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease, which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permit me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether m patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly, impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

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February 5, 2009

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to revisit your proposal to include PET/CT coverage for the subsequent treatment period as well.

Less

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PET/CT scans. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PET/CT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PET/CT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy and/or whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

Less

To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PETICT scans. I firmly agree that the coverage of PETICT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PETICT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PETICT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PETICT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the aVOidance of surgeries and other localized treatments that would have proven ~utile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PETICT, pursuing localized treatments only to find out that such coursesiof action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PETICT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PETICT t,requently replaces multiple imaging modalities, saving my patients time, radiation expQsure, costs and'inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PETICT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PETICT scaAS in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PETICT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PETICT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PETICT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PETICT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andlor whether they are relapsing. The information provided by PETICT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PETICT coverage for the subsequent treatment period as well.

Less

To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent of the disease and determining an appropriate course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction. However, from my perspective, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans by the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is vitally important that I am able to order a PET/CT scan in the treatment planning position- the same exact position in which the patient will receive daily treatments. Some of these patients may have undergone surgery and/or chemotherapy since their initial scan. A PET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior) provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.
2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et al 2003). In my practice, I have seen patients with cancers which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.
3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post-therapy changes are very difficult to differentiate from active disease on a CT alone; however, PET/CT allows me to do just that. I cannot use an inferior imaging modality which will often be indeterminate to decide whether or not my patients require salvage treatments which may impact their overall survival. One of the key advantages of PET/CT is the ability to assess residual or recurrent disease 2-3 months sooner than conventional imaging. For a patient with cancer, this time is crucial.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but I am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

Less

To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent of the disease and determining an appropriate' course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction, However, from my perspec,tive, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans I:>y the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is vitally important that I am able to order a PET/CT scan in the treatment planning position- the same exact position in which the patient will receive daily treatments. Some of these patients may have undergone surgery and/or chemotherapy since their initial scan. A ET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior) provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.
2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et al 2003). In my practice, I have seen patients with cancers which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.
3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post-therapy changes are very difficult to differentiate from active disease on a CT alone; however, PET/CT allows me to do just that. Other imaging modalities are inferior to PET/CT in measuring the effects of treatment quickly. One of the key advantages of PET/CT is the ability to assess residual or recurrent disease 2-3 months sooner than conventional imaging. For a patient with cancer, this time is crucial and allows us to proceed with salvage therapy more quickly if needed.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but I am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

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To whom it may concern:

Thank you for receiving my feedback regarding the proposed expansion of coverage for oncologic PETICT scans. I firmly agree that the coverage of PETICT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PETICT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans fail to provide adequate information regarding my patients' conditions. As my experience with PETICT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PETICT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the aVOidance of surgeries and other localized treatments that would have proven ~utile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PETICT, pursuing localized treatments only to find out that such coursesiof action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PETICT may rule out disease which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PETICT t,requently replaces multiple imaging modalities, saving my patients time, radiation expQsure, costs and'inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PETICT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PETICT scaAS in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PETICT scans for all solid tumors in the subsequent treatment period as well. Many of my patients have been permanently anatomically altered by surgeries and other localized therapies. Anatomic imaging modalities often yield equivocal results identifying post-treatment changes with an inability to discern scar tissue from active disease. By coupling the metabolic activity with anatomic landmarks, PETICT is more accurately able to make this distinction, allowing earlier salvage interventions, thereby impacting patient outcomes. Waiting until this distinction becomes clear on anatomic imaging increases the likelihood of the disease becoming disseminated, negatively impacting patient prognosis. During treatment, it has been found that PETICT identifies metabolic changes that take place months before anatomic changes, thereby identifying responding and non-responding patients earlier. Early identification of non-response allows me to stop exposing my patient to toxicities and costs associated with ineffective therapies and permits me to initiate potentially more effective treatment, sooner. Overall, using PETICT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andlor whether they are relapsing. The information provided by PETICT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses.

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PETICT coverage for the subsequent treatment period as well.

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I am at the Cedars Sinai Medical center in Los Angeles California. I serve as director of nuclear Medicine and Co-Chairman of imaaging.

I am in favor of expanding the indications for PET CT. The NOPR data clearly demonstrated the need for expanded indications for PET/CT imaging. We have found that limiting PET indications encourages physicians to order inferior testing modalities and will delay diagnosis with actual added expense in the long run. Pet CT for multiple tumor types has been shown to improve/change patient management in 14-40 percent of cases.

We would like to see s system where educated oncologists will appropriatey order diagnostic studies which will expedite correct diagnosis and facilitate patient management decisions.

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There is a vital need to develop quantitative assessment methods of cancer therapy response. CT and standard MRI cannot provide information on the molecular, biochemical and physiologic properties of cancer tissues. Therefore, quantitative imaging techniques and protocols are needed to reveal biomarkers of molecular events induced by cancer therapy. In particular, early imaging of molecularly targeted pathways predicted to be essential for effective cancer therapy is highly likely to play a key role in cancer patient therapy management in the future. FDG-PET can assess the glycolytic response of tumors to chemotherapy and data support that decreases in FDG uptake during the first weeks of chemotherapy are significantly correlated with patient outcome (Weber).

As imaging response assessment team (IRAT) project leader over the past three years we have made significant strides here at the University of Pittsburgh''s Cancer Institute to develop FDG PET protocols by which we can obtain a single research PET scan on patients after their first dose of therapy, but immediately preceding their second dose to determine how changes in metabolic activity correlate with outcome. I have also found that decreases in metabolic activity very early in the course of therapy correlates with a beneficial long term outcome.

Therefore, my comment specifically focuses on the necessity for coverage for early therapy assessment FDG PET scan study participation. Using an early therapy FDG PET scan will allow for standardization of PET-CT protocols, to accurately and reproducibly measure changes in metabolic imaging biomarkers during cancer therapy trials. Development and use of quantitative PET imaging for early therapy assessment will greatly facilitate patient management, by sparing patients from weeks or months of toxicity and ineffective treatment.

Weber WA. Positron emission tomography as an imaging biomarker. J Clin Oncol 24: 3282–3292, 2006.

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DATE: February 4, 2009

RE: Comments to CMS on the Proposed Decision Memo for Position Emission Tomography (FDG) for Solid Tumors (CAG 00181R)

MedSolutions, Inc. performs medical necessity review of PET and PET/CT (collectively referred to as PET) imaging requests as part of our Radiology Benefit Management program on behalf of our client health plans. We perform these services for more than 20 million members/patients in the commercial health insurance sector, managed Medicaid, state Medicaid, and Medicare Advantage plans. Submitted clinical information on individual cases is reviewed according to our own proprietary guidelines. For oncology imaging, these guidelines are based heavily, but not exclusively, on recommendations made in National Comprehensive Cancer Network (NCCN) and American College of Radiology (ACR) publications, as well as reviews of relevant medical literature, input from health plan medical directors, and input from outside consultants who are recognized experts in the field of PET imaging.

Currently, MedSolutions receives pre- authorization requests for approximately 1,850 PET scan studies per month. This represents 2.3% of all imaging requests received by MedSolutions, with the other modalities being CT, MRI, and nuclear cardiac (SPECT) studies. During a recent representative quarter, denial rates for PET ranged from 16-18%. A large percentage of the denied PET scans were for requests to image patients who were under surveillance post-therapy, a situation uniformly considered to be an inappropriate use of PET. Other reasons for denial included situations in which the submitted clinical information showed that adequate information was available from standard imaging studies, situations in which prior PET scans had rendered a repeat PET scan redundant, and situations in which the role of PET is considered less desirable or unreliable, such as prostate cancer. Our 16-18% denial rate for PET scans suggests a tendency of physicians to quickly expand use of PET beyond what the medical literature will support, and possibly a lack of understanding regarding the appropriate clinical indications for PET.

MedSolutions respectfully offers the following comments regarding the proposed decision by the Centers for Medicare and Medicaid Services (CMS) to revise the current coverage determinations for oncologic FDG-PET imaging.

Although MedSolutions appreciates the effort to simplify the CMS coverage framework into two categories—“initial treatment” and “subsequent treatment”—we would urge caution in this regard. The “subsequent treatment” category will by necessity encompass a large group of clinical entities and it will be very difficult to develop an appropriate coverage policy for this group of patients. In some instances, as with lymphoma, it will be appropriate to obtain a PET scan after two to four cycles of chemotherapy, and then a second PET scan after chemotherapy is complete. In other cancers, it will be appropriate to routinely obtain only one PET scan or no PET scans during “subsequent treatment.” However, if there is known or suspected recurrence, then PET scan would be appropriate.

1) CMS should consider the following categories for coverage framework:
a) Initial treatment
b) Interim restaging (defined as advanced imaging used to monitor or assess the response to therapy in a patient undergoing active treatment)
c) Final restaging (defined as advanced imaging performed after therapy is completed)
d) Known or suspected recurrence (based upon physical examination, laboratory studies, conventional imaging, and/or biopsy)
e) Surveillance (patient is assumed to have either no known disease, or stable or clinically insignificant disease)
It will be very important to ensure that precise ICD-9 (or ICD-10) codes are available that reflect each of these terms.

2) In defining “initial treatment” CMS should specify that the solid tumor must be biopsy proven unless biopsy is technically difficult since PET is very rarely used for diagnosis and should not replace biopsy. In addition, CMS should specify what “strongly suspected based on other diagnostic testing” means. Otherwise, there will be a huge potential for PET scans to be performed inappropriately for e.g. nonspecific abnormalities seen on other imaging studies, a mildly elevated CEA level or other tumor marker, various “lumps and bumps” found on physical exam, or unexplained weight loss.

3) In addition to adenocarcinoma of the prostate, CMS should include the following as exceptions to the decision to allow FDG PET for initial treatment: a) all skin cancers other than melanoma b) primary brain tumors c) uterine cancer d) squamous cell cancers of the anal margin, perianal, and perigenital regions

4) MedSolutions strongly supports restricting the coverage of FDG PET imaging in solid tumors when determining subsequent treatment strategy to coverage with evidence development. While NOPR has shown that PET changes management in a large number of cases, CMS rightly maintains that outcomes data showing that patients have better outcomes as a result of the PET scan and management change should be produced before coverage for PET is further expanded. MedSolutions applauds this approach.

5) MedSolutions supports expanding NOPR to fulfill the outcomes-based requirements and additional AHRQ requirements in order to continue coverage with evidence development rather than starting from scratch to develop another platform for obtaining outcomes-based data.

6) CMS should consider implementation, on either a pilot or regional demonstration project platform, of a prior authorization program for PET and PET/CT studies that would use widely accepted medical necessity criteria (clinical guidelines) as a basis for authorizing payment for studies that fall within these evidence- based guidelines. Such an approach has recently been recommended by the GAO for many of the high tech imaging modalities, including MR, CT, and PET.

In conclusion, based on our expertise and significant experience adjudicating close to 2,000 requests for PET scans each month, MedSolutions supports judicious expansion of coverage by CMS for PET scans. However, there is still significant inappropriate use and over- utilization of PET, and expansion of coverage will likely exacerbate this problem. By using careful judgment and perhaps employing the recommendations outlined above, the benefits of PET can be extended to a wider patient population while minimizing the pitfalls of over- utilization.

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Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R))

Dear Dr. Phurrough,

Lung Cancer Alliance (LCA) appreciates the opportunity to comment on the draft decision memo on Medicare Coverage of Positron Emission Tomography. Coverage determinations are difficult and challenging. We commend the Centers for Medicare and Medicaid Services (CMS) for recognizing the importance of developing appropriate physician and patient based methods to determine coverage for new tests and treatments, especially in the rapidly evolving area of imaging.

LCA is the only national non-profit organization devoted solely to support services and advocacy for lung cancer patients, their caregivers and families, and for those at risk for the disease. Lung cancer continues to take more lives each year than all the other major cancers combined and its 5-year survival rate is still only 15%. For the first time, advances in imaging are dispelling the nihilism long associated with this disease and offering patients and their doctors more effective ways to accurately diagnose and tailor treatments and change outcomes in lung cancer

The data collected under the National Oncologic PET Registry (NOPR) confirmed the importance of PET to doctors in determining the best course of action in treating their patients and validated previously made coverage decisions for the diagnosis, staging, restaging and treatment monitoring of non-small cell lung cancer (NSCLC). We strongly support the decision to maintain full coverage status in the transition to the new categories of “initial treatment strategy” and “subsequent treatment strategy.”

However we are concerned that coverage for the initial treatment strategy for small cell lung cancer (SCLC) would be limited to one PET and only covered for subsequent treatment strategy within the context of the NOPR.

We would urge full coverage for SCLC for both categories. While once a far more significant percentage of all lung cancers, SCLC cases now account for approximately 5 to 10% of new lung cancer diagnoses. It is however, as challenging as NSCLC, if not more so in diagnosis, which may require more than one PET, staging, treatment and follow up. Doctors of SCLC patients need to be able to fully utilize the ability of PET to help guide these decisions in a timely manner. We also hope that CMS will work to ensure that there is no coverage gap during the transition from NOPR to the new CED study so that patients have uninterrupted access to critical PET scans.

We thank you again for making the needs of doctors and their patients the primary factor in coverage decisions.

Sincerely,

Laurie Fenton Ambrose
President and CEO
Lung Cancer Alliance
888 16th Street NW
Suite 150
Washington, DC 20006
Phone:(202) 463-2080
Fax: (202) 463-7497
LFenton@lungcanceralliance.org
www.lungcanceralliance.org

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February 4, 2009

To Centers for Medicare and Medicaid services Re: the NOPR program for coverage of PET/CT under Medicare

Dear Sir/Madam:

The H. Lee Moffitt Cancer Center has been a participant in the Medicare NOPR program for coverage of PET/CT scans since its inception. Over 250 patients at Moffitt cancer center have participated in this program. In particular 231 of patient’s with pancreatic cancer from the Moffitt gastrointestinal oncology program have benefited from this program. Our institutional experience has shown that PET scans are instrumental in the staging and monitoring of treatment response in patient’s with pancreatic adenocarcinoma. In particular we have used the data generated under the NOPR program to review our institutional experience with PET/CT in the pre-operative staging of pancreatic cancer patients. We have learned that greater than 85% of pancreatic tumors are hypermetabolic. We are currently reviewing data that indicates that a decrease in hypermetabolic activity on PET scan maybe predictive of subsequent successful margins negative surgical resection. In more than 10% of cases occult metastasis are identified and as a result planned surgical resection (pancreaticoduodeneectomy) is avoided. This results in significant savings in cost and morbidity for patients. Some of these findings have already been published in peer reviewed journals (see separate email with attachment). The current program is efficient, user friendly and creates a minimal of imposition on clinical care activity by the physician to report the findings for each patient. I hope that CMS will keep this valuable program for our patients intact.

Sincerely,

Gregory Springett, MD, PhD

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CMS has been presented with compelling evidence of the efficacy of FDG-PET scan. Not including broad coverage for these cancer indications in NOPR''s request still leaves PET scans out of reach for many patients. Remember, patients do not have time on his/her side! Coverage for response to treatment improves patient care PLUS assurance healthcare dollars are used wisely.

Your careful reconsideration including the request as submitted is in the best interest of the patient.

Respectfully submitted,
Laurel Pracht

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PET scans are invaluable in my practice is a radiation oncologist. Radiation therapy is dependent upon not only accurate radiographic anatomic detail but functional imaging such as PET scans. Without functional imaging, it is nearly impossible to detect scar deposition versus recurrent disease particularly in the setting of pancreatic cancer in which multiple bouts of pancreatitis are antecedent. In situations where patients have received prior chemotherapy and are referred for salvage treatment with radiation therapy, PET imaging for radiation therapy planning is essential for tumor definition. I recall the specific incidence of a 22-year-old with a soft-tissue sarcoma involving the pericardium which was resected prior to radiation therapy. I requested a PET scan for radiation treatment planning and was alerted to an area of residual disease just outside of the tumor bed which was not visualized in the postoperative MRI. The area of disease would otherwise and not have been included in the radiation field and whether thus service as nidus for disease progression. Another incidence in which PET scanning has proven valuable is in the case of a 48 year-old woman that is currently receiving radiation therapy to the chest, mediastinum and right supraclavicular region for a mixed small and non-small cell lung carcinoma. Because of the extensiveness of disease at the time of presentation, I recommended upfront chemotherapy in hopes of decreasing disease burden and allow treatment with radiation via smaller radiation portals. A CT scan performed after completion of chemotherapy suggested a near-complete response to treatment. A PET scan performed a few days later confirmed significant disease regression following chemotherapy but demonstrated an area of increased uptake within the aortopulmonary window suggestive of metastatic adenopathy. This area would not have otherwise been covered with radiation due to its lack of proximity to the other areas of disease. In conclusion, PET imaging is essential for solid tumor diagnosis, treatment and monitoring. I am hopeful that CMS will recognize that the future oncology is moving towards individualized care which is greatly augmented by the ability to not only visualize areas of possible disease but also whether these areas are functionally active.

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February 4, 2009

Steve Phurroug Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, Maryland 21244

Dear Dr. Phurrough:

The Association of Community Cancer Centers (ACCC) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed national coverage decision (NCD) on positron emission tomography (FDG PET) for solid tumors.¹ We urge the agency to finalize its proposal to cover the use of FDG PET to help determine the appropriate initial treatment strategy for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing. Further, we believe that CMS also should finalize its proposal to cover the use of FDG PET, without Coverage with Evidence Development (CED), in the determination of subsequent treatment strategy for patients with breast, cervix, colorectal, esophagus, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid² cancer.

ACCC appreciates CMS’s new two-part coverage framework to replace the four-part diagnosis, staging, restaging, and monitoring framework. CMS also proposes to use CED to study the use of FDG PET in the subsequent treatment strategy for treating other cancer types, and ACCC believes this is a reasonable approach that the agency should finalize. In finalizing this proposal, however, ACCC asks the agency to provide greater detail regarding its plans to implement CED in a way that preserves continuity of care. ACCC believes that the NCD proposed coverage framework affords physicians and patients with another state-of-the-art tool to fight cancer more effectively.

ACCC is a membership organization whose members include hospitals, physicians, nurses, social workers, and oncology team members who care for millions of patients and families fighting cancer. ACCC’s more than 700 member institutions and organizations treat 45% of all U.S. cancer patients. Combined with our physician membership, ACCC represents the facilities and providers responsible for treating over 60% of all U.S. cancer patients. We are often at the front line in fighting cancer and therefore have a unique perspective on how FDG PET affects patient care and often improves health outcomes.

FDG PET is a non-invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues in the human body. Images are obtained by processing of emissions from positron-emitting radioisotopes that usually are administered intravenously. The rate of FDG decay provides information on glucose metabolism of tissues being studied. As malignancies can cause abnormalities of glucose metabolism, FDG evaluation can indicate the probable presence or absence of malignancy based upon observed differences in biologic activity of adjacent tissues. In January of 2005, CMS instituted a CED requirement for the use of FDG PET in certain cancer types. The purpose of the CED was to develop evidence on the utilization and impact of the item or service evaluated in the NCD, so that Medicare can a) document the appropriateness of use of that item or service in Medicare beneficiaries under current coverage; b) consider future changes in coverage for the item or service; and c) generate clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding the item or service.

Various stakeholders, with the support of CMS, established and maintained the National Oncologic FDG PET Registry (NOPR) to study the effect of FDG PET on clinical decision-making as part of an April 18, 2005 NCD.3 CMS required providers to submit data to a registry as a condition of coverage of the FDG PET. Some of the results of this study were published in a March 2008 issue of the Journal of Clinical Oncology.4 ACCC appreciates the efforts of the NOPR Working Group in synthesizing the data collected through the registry. Our members are committed to increasing the clinical data available for use in treatment decisions through expanded clinical research and believe that the efforts of the NOPR Working Group have achieved that goal.

The Journal of Clinical Oncology study shows that FDG PET utilization was associated with a 36.5% change in the treatment or no-treatment decision of the physician. This includes the full scope of potential uses of FDG PET in the diagnosis and treatment of a particular cancer. Further, the data demonstrate that physicians stated that they often changed their intended management of the respective cancer based on the FDG PET results. Additionally, where the pre-PET treatment plan was biopsy, FDG PET led to a decision to avoid surgical intervention 75% of the time, leading to the possibility of improvement in patient care. Due to the affect that FDG PET had in enhancing the clinical-decision making process, we believe that CMS should finalize its proposals.

We fully recognize, however, the limitations of the NOPR data in linking the use of FDG PET to patients’ long-term clinical outcomes. The authors state that a major limitation of the data is the inability to determine if the change in intended management led to better clinical outcomes for Medicare beneficiaries. The NOPR, however, deliberately was designed to measure change in intended patient management strategy, not actual change in management or long-term patient survival. Second, as a result of the inherent weakness of the NOPR, the authors could not address whether FDG PET should be used in lieu of other imaging techniques or instead as a complement to the current standard of care. ACCC agrees with these limitations, but nonetheless believes that this diagnostic tool has significant benefits in determining the right course of treatment for many cancer patients.

ACCC is committed to ensuring that cancer patients have access to the entire continuum of quality care and all available clinical information about their disease. As such, in addition to finalizing these coverage proposals, we urge the agency to clarify in its final decision how it plans to ensure that patients who require FDG PET to guide “subsequent treatment strategies” under the CED requirement will receive uninterrupted access to this state-of-the art care. Under the proposed decision, CMS would provide coverage for FDG PET to guide “subsequent treatment strategies” only if the beneficiary is enrolled in a clinical study pursuant to a CED framework that meets certain listed criteria. ACCC urges CMS to detail in its final decision a clear pathway for Medicare beneficiaries to continue to access FDG PET. This pathway should include practical and specific information to guide beneficiaries and their physicians to access these clinical trials and obtain Medicare coverage.

ACCC is grateful for CMS and the NOPR Working Group’s hard work and dedication in collecting and analyzing the clinical data associated with FDG PET. As a result, our members now have a clearer understanding of the value that FDG PET adds to physician’s treatment decisions for certain types of cancer. We urge CMS to carefully monitor the results of the upcoming CED on the use of FDG PET for the subsequent treatment strategy for brain, ovary, pancreas, prostate, small cell lung, soft tissue sarcoma, testes, and all other solid tumors. Our members constantly search for tools to appropriately treat and manage cancer and should the clinical benefits of FDG PET continue to evolve, we hope the agency would act quickly to remove the CED coverage restrictions to afford broader access to this important technology.

We would be pleased to answer any questions regarding these comments. Please contact Matt Farber at 301-984-9496 ext. 221 if ACCC can be of any assistance as CMS continues to evaluate FDG PET.

Sincerely,

cc: Louis Jacques, MD, Division Director
Steve Caplan, RN, MAS, Lead Analyst
Katherine Tillman, RN, MA, Analyst
Shamiram Feinglass, MD, MPH, Medical Officer
Jeffrey C. Roche, MD, MPH, Medical Officer

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February 4, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Positron Emission Tomography (FOG) for Solid Tumors (CAG-00181R)

Dear Dr. Phurrough,

Lung Cancer Alliance (LCA) appreciates the opportunity to comment on the draft decision memo on Medicare Coverage of Positron Emission Tomography. Coverage determinations are difficult and challenging. We commend the Centers for Medicare and Medicaid Services (CMS) for recognizing the importance of developing appropriate physician and patient based methods to determine coverage for new tests and treatments, especially in the rapidly evolving area of imaging.

LCA is the only national non-profit organization devoted solely to support services and advocacy for lung cancer patients, their caregivers and families, and for those at risk for the disease. Lung cancer continues to take more lives each year than all the other major cancers combined and its 5-year survival rate is still only 15%. For the first time, advances in imaging are dispelling the nihilism long associated with this disease and offering patients and their doctors more effective ways to accurately diagnose and tailor treatments and change outcomes in lung cancer.

The data collected under the National Oncologic PET Registry (NOPR) confirmed the importance ofPET to doctors in determining the best course of action in treating their patients and validated previously made coverage decisions for the diagnosis, staging, restaging and treatment monitoring of non-small cell lung cancer (NSCLC). We strongly support the decision to maintain full coverage status in the transition to the new categories of "initial treatment strategy" and "subsequent treatment strategy."

However we are concerned that coverage for the initial treatment strategy for small cell lung cancer (SCLC) would be limited to one PET and only covered for subsequent treatment strategy within the context of the NOPR.

We would urge full coverage for SCLC for both categories. While once a far more significant percentage of all lung cancers, SCLC cases now account for approximately 5 to 10% ofnew lung cancer diagnoses. It is however, as challenging as NSCLC, if not more so in diagnosis, which may require more than one PET, staging, treatment and follow up. Doctors of SCLC patients need to be able to fully utilize the ability of PET to help guide these decisions in a timely manner. We also hope that CMS will work to ensure that there is no coverage gap during the transition from NOPR to the new CEO study so that patients have uninterrupted access to critical PET scans.

We thank you again for making the needs of doctors and their patients the primary factor in coverage decisions. NO MORE LUNG CANCER.

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February 4, 2009

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG 00181R)

Dear Dr. Phurrough:

US Oncology, headquartered in Houston, Texas, is one of the nation's foremost cancer treatment and research networks. US Oncology provides extensive services and support to its affiliated cancer care sites nationwide to help them expand their offering of advanced treatments and technologies, build integrated community-based cancer centers, improve their therapeutic drug management programs and participate in many of the new cancer-related clinical research studies. US Oncology also provides a broad range of services to pharmaceutical manufacturers, including product distribution and informational services such as data reporting and analysis. According to the company's last quarterly earnings report, US Oncology is affiliated with 1,227 physicians operating in 485 locations, including 92 radiation oncology facilities in 39 states.

On behalf of the US Oncology Physician Network, thank you for the opportunity to respond to the Centers for Medicare & Medicaid Services (CMS) request for additional comments regarding the recent proposed decision memorandum regarding oncologic fluorodeoxyglucose (FDG)-PET imaging. We applaud the cooperative approach taken by CMS, the Academy of Molecular Imaging, and the PET and oncology communities in general toward the gathering of vital clinical data, utilizing the “coverage with evidence development” (CED) mechanism, as implemented in the National Oncologic PET Registry (NOPR). We are encouraged by the overall progress of this cooperative effort, and we are in general agreement with the current proposal to increase the coverage of PET imaging for various tumors that have recently been covered under the CED mechanism. However, we have several concerns regarding the proposed coverage framework that we ask CMS to address in the final coverage decision.

While we welcome the expanded coverage currently proposed, we reiterate our previous assertions in prior comments, which echo those of the initial requestors, that FDG uptake, as a surrogate for glycolytic metabolic activity within malignant tissues, is generally applicable for tumor assessment in the vast majority of cancers. The unprecedented scope of the NOPR data further demonstrates that FDG-PET imaging provides crucial additional information in the evaluation of cancer patients – information that very often alters patient management, frequently reducing the cost and morbidity of cancer care. While it is clear that more specific data regarding PET’s impact on patient outcomes would be highly desirable, the currently available information, including the recent analyses of the NOPR data, are sufficient to infer the unique value of PET in cancer care. Though the quality of the data that have been recorded over the past three decades of PET’s use in oncology is often less than ideal, the overall body of evidence provides overwhelming support for the generalized use of PET in oncologic patient management.

To boil this down to the most simple and direct argument and application, the vast majority of imaging-based decisions in oncology currently hinge on the results of computerized tomography (CT) examinations. Because of the tremendous value of CT in oncology, and the resultant dependence on CT that has evolved in cancer management, the large majority of research studies involving PET have compared the accuracy of these two modalities. In the entire breadth of the extant literature, PET has proved superior to CT in the vast majority of studies, while rarely proving to be only equivalent to CT and extremely rarely inferior to CT.

There are clearly instances in which PET generally is less likely to be helpful, such as in some of the known, poorly-FDG-avid tumors like most prostate carcinomas. In many such cases, CT, MRI, and other non-invasive diagnostic tools also have substantial limitations except in specific situations. The referring clinician, with direct knowledge of the patient’s specific tumor characteristics and the various imaging and non-imaging diagnostic tools available and appropriate for the patient, should be allowed to make the decisions regarding optimal patient evaluation. While there may be concerns regarding tendencies toward “overutilization” caused by the ordering of both CT and PET, such tendencies will fade rapidly, especially with the incorporation of CT images into the combined-modality PET/CT examination.

We also reiterate the impracticality of gathering optimal data regarding the value of PET for every conceivable clinical decision branch-point for every tumor type and subtype. Such studies literally could take decades to perform, especially if there is no facile means to fund the hundreds of thousands of patient PET examinations that would be necessary to provide such data. Current data clearly show that PET is a tool that offers substantive value in broad-scope tumor evaluation with a few notable exceptions, rather than vice versa. Continuation of narrow, tumor-by-tumor evaluations and restrictions will adversely affect patient care for years to come. Therefore, the US Oncology Physician Network requests that CMS adopt an omnibus framework that provides coverage of PET across all oncologic indications requested by the NOPR Working Group.

Proposed Decision Memorandum

If an omnibus approach is not included in the final coverage decision, we have several specific concerns regarding the current proposal. We strongly support the proposed reclassification of indications for PET imaging, as defined in the memorandum. As CMS has noted, this simplified classification system more closely relates to how oncologic physicians approach patient management. However, there are a few major omissions that could pose substantial problems for a large number of patients.

One specific such omission involves the use of PET imaging for radiation therapy planning. Many patients undergo a first PET study for diagnosis or initial staging and are subsequently stratified, based on PET and other clinical criteria, to a group in which radiation therapy is the treatment of choice, or at least part of the treatment regimen. Increasingly, the value of PET imaging in radiation planning is being realized. However, in the vast majority of cases, the initial PET study is inadequate for use in such treatment planning for a variety of technical reasons, mostly related to differences in optimal patient positioning for a “planning” scan versus a routine staging scan, and a separate, typically limited, PET study must be performed for adequate therapy planning. The current framework does not appear to allow for an additional planning PET study prior to initiation of treatment. The final national coverage determination should provide for an additional PET study for use in radiation planning, before therapy.

Another apparent omission in the proposed coverage language involves patients who may legitimately require multiple PET scans during a prolonged period of evaluation and staging of a difficult-to-diagnose cancer. Although uncommon, some PET scans performed for initial diagnosis of a cancer yield false-negative results. This is often due to small size of the lesion, low FDG-avidity of the lesion, or close apposition of a lesion to organs or tissues that have even greater FDG activity, such as a mildly hypermetabolic lesion within the liver. Such patients are often followed conservatively for several months, or even up to a year or more, in order to ensure that the questionable lesion does not progress. If, during that follow-up period, progression is observed, a repeat PET study may be appropriate, as the lesion may have grown to a size more accurately evaluated by PET.

Alternatively, if a diagnosis of cancer is made several months after an initially negative PET scan, a PET scan may still be necessary for optimal initial staging. A typical example would involve a small, solitary pulmonary nodule that appears negative or indeterminate on an initial PET study. If, six months later, that lesion has doubled in size on chest x-ray or CT, and subsequent biopsy confirms a diagnosis of lung carcinoma, a repeat PET would be indicated for staging of the mediastinum and, in particular, for evaluation of the possibility of interval development of distant metastases.

The final national coverage determination should clarify the limitation to a “single” PET scan for Diagnosis/Staging to allow for coverage of additional “initial treatment” scans in such circumstances.

The US Oncology Physician Network strongly supports the decision to lift the CED requirements for the “Initial Treatment” PET scans performed on patients with solid tumors, as outlined in the memorandum. However, since there may be some confusion among physicians and carriers regarding whether myeloma should be included in the category of solid tumors, and since the NOPR data show a substantial impact of PET on the management of such patients, the final national coverage determination should clarify that myeloma is included in this change in coverage.

We also support the inclusion of the previously covered tumor types (breast, colorectal, esophagus, head & neck, lymphoma, melanoma, NSCLC, thyroid, and cervix) in the group of tumors covered without CED restrictions under the more clinically workable category of “subsequent treatment,” as a replacement for the prior categorizations into restaging and treatment monitoring. While all solid tumors should be included in this coverage, if CMS does not adopt an omnibus coverage framework, all tumors for which other diagnostic options have well-documented limitations should be moved from “CED” to “Covered” for the “Subsequent Treatment” category.

The existing data for ovarian carcinoma shows that PET is sufficiently superior to other imaging modalities for evaluation after initial treatment to be covered without CED. Myeloma is another example of a tumor for which other imaging modalities have been demonstrated to be of very limited value in the assessment of disease activity. The favorable results from the PET studies contained in the existing literature have led to PET becoming the standard of care in most major medical centers with specialized myeloma treatment programs, and coverage without CED restrictions is appropriate in this relatively small patient population.

For other tumors, such as pancreatic carcinoma and small cell lung carcinoma, both prognosis and treatment options are often limited. For this reason, some would argue that PET’s role in treatment follow-up is more limited, and this may well be the case in most such patients. However, there are subgroups of these patients in whom decisions regarding the advisability or likelihood of success of continued, different, or more aggressive treatment options are critical; and, based on NOPR and other data, those decisions are better made with the help of PET imaging. The vital information gained through PET imaging should be available to these unfortunate patients and their physicians, without the restriction of CED.

If an omnibus strategy toward PET coverage of these tumors is not adopted in the final coverage decision, the patient groups listed as CED under the new framework should continue to have access to PET imaging. We recognize that if CMS determines that further study is needed, a modified study design for CED may need to be implemented, with particular attention to patient outcomes. If this is the result, CMS should work with its partners in the imaging and oncology communities to frame and initiate such as study as quickly as possible. If it is not practically possible to develop and implement such a study by the time the NCD is finalized, CMS should continue the current CED approval for the affected tumor types, under the current NOPR guidelines or under a separate mechanism that is suitable to all involved parties. It is imperative that there be no interruption in the coverage of PET imaging for these patients in whom PET can make such dramatic changes in decisions regarding subsequent treatment.

In specific regard to the questions posed in the coverage decision memorandum:

1. Should the current framework for evaluating the use of FDG PET imaging be modified as proposed?

   Yes. This model more closely resembles the clinical approach to the oncology patient in most cases. However, specific approval for a second “initial treatment” PET scan should be allowed, when appropriate, for the purposes of radiation therapy planning and/or to account for cases requiring prolonged evaluation and/or staging.

2. Does the evidence support the broad expansion of coverage of FDG PET imaging to all solid tumors when determining initial treatment strategy?

   Yes. The preponderance of evidence in the literature, including the data from NOPR, support the generalized use of FDG-PET for the assessment of the presence, extent, and activity of the vast majority of solid tumors.

3. Does the evidence support the restriction of coverage of FDG PET imaging in solid tumors when determining subsequent treatment strategy to coverage with evidence development?

   No. The extant literature, especially that provided by NOPR, is sufficient to allow broad coverage of PET for the assessment of disease extent and activity in all solid tumors. While there are specific subgroups and individual patients for whom FDG-PET is less useful, the decisions of whether/when to use PET in an individual patient are best made by the physician directly caring for that patient. To delay coverage to the large majority of patients who would legitimately benefit from such coverage while waiting on more specific data in smaller and smaller subgroups of tumor types and indications impedes optimal patient care.

4. For breast cancer and melanoma that have noncoverage for initial treatment strategy, is there evidence that would support their removal from the list of exceptions to coverage for initial treatment strategy?

   No. CMS has appropriately adopted the position that PET is a highly valuable tool for the staging of possible distant metastases, but, with current technology, does not reach the accuracy levels of sentinel node biopsy for regional lymph node staging or sufficient accuracy for distinguishing benign from malignant indeterminate breast masses. Technologies currently in development may warrant a fresh look at this question at a later date.
5. For the nine cancers that have coverage for subsequent treatment strategy, is there evidence that would support restricting their coverage to CED?

   No. CMS’ initial coverage decisions for these tumors (in 2001-2003) were generally appropriate, and certainly not too liberal. To restrict these tumors to coverage with evidence development in the new framework would require that there be significant data published since 2001 to indicate that the value of PET imaging in these tumors is less than previously concluded. Quite the contrary is the case.

   
   

   The literature on oncologic PET has expanded dramatically since these tumors were originally covered. Furthermore, PET technology has greatly improved with the widespread availability of PET/CT scanners and with data collection and reconstruction parameters that allow for much better practical resolution than was available with the conventional PET scanners used to generate most of the literature leading to these prior coverage decisions. While the quality of many of these clinical studies may have been suboptimal, the overwhelming body of evidence supports PET’s role in these oncologic decision processes. The fact that some studies have shown that there are specific tumors or specific clinical questions that may not be optimally addressed by PET is simply a natural refinement – one that is to be expected on a continual basis in a field so complex as cancer care. As cancer treatment strategies grow more complex, more costly, and, sometimes, more toxic, it is crucial that physicians have all of the appropriate tools available to them to determine whether a prescribed course of therapy is working or whether a new treatment path should be explored.

We appreciate the opportunity to comment on the draft coverage decision memorandum. As a cancer care network, US Oncology is dedicated to providing optimal, compassionate, and appropriate care to our patients. We are also dedicated to research that is aimed at refining our treatment strategies, both in terms of new technologies and in terms of more structured, evidence-based approaches to cancer care. We are cognizant of the increasing financial burden that the growing cost of cancer treatment places on both patients and payers. This is one reason we have been particularly pleased by data from NOPR and elsewhere that suggest that appropriate utilization of PET often decreases both the expected morbidity and the expected cost of subsequent procedures in many patients.

We have no doubt that clinical investigators will continue to gather data regarding the utility of PET in a wide variety of both specific and general oncologic applications. We also are convinced that, as has happened with other imaging modalities, physicians will quickly gravitate to the modality that provides optimal information for the care of each specific patient and will discontinue (or fail to adopt) the use other modalities that are less helpful. In certain complicated cases, multiple modalities may be brought to bear, as necessary. However, in the case of PET, this expected evolution of clinical practice should serve to accelerate, not impede, the availability of what has proved to be a nearly universally beneficial tool in cancer management.

We look forward to continuing to work with you toward full coverage of PET imaging services for Medicare beneficiaries with cancer. Please contact me if you have any questions.

Sincerely,

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I''m deeply disappointed to see that more data should be obtained for expansion of PET coverage in many cancer types, particularly particularly for cancers for which there are few diagnostic options to aid the physician in developing a course of treatment or in monitoring recurrence and follow-up treatment, including, the following.

Ovarian cancer, pancreatic cancer, lung cancer: according to NOPR data, change in management occurs in ~ 40% for staging,restaging, and for suspected recurrence.

Especially in patients with myeloma there is absolutely no other whole body imaging modality as effective as FDG PET: change in management occurs in ~50% for staging, restaging, and at the time of suspected recurrence. For myeloma, oncologists always resort to PET i the decision making process. We''re all in disbelief, PET coverage was not extended to include myeloma and this is a rare tumor thus collection of more data to satisfy CMS will not be possible under realistic circumstances.

Please reconsder to cover the above cancers, thus give physicians the same latitude in use of PET that they have with CT and MRI.

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The Blue Cross and Blue Shield Association (BCBSA), an association of 39 independent Blue Cross and Blue Shield Plans that collectively provide health insurance benefits to 102 million Americans, appreciates the opportunity to comment on the national coverage determination proposed by the Centers for Medicare and Medicaid Services (CMS) to expand coverage for initial diagnostic testing with positron emission tomography (PET) for many Medicare beneficiaries who are being treated for cancer.

Our key concern is with the new category "subsequent treatment." We think that assessing response to therapy and monitoring for disease recurrence are distinct indications that should not be combined. It is important to define specifically what is meant by response to treatment — Is PET to be performed during a course of treatment to potentially alter treatment modalities or is it to determine the patient’s status (disease stage) at the end of the full course of therapy? These are very different questions and may need to be addressed with different data sets. Moreover, we believe that managing most tumors and their course presents many additional questions. One in particular concerns the monitoring of disease (and its frequency) in asymptomatic patients. Therefore we would not modify the existing framework to use "subsequent treatment" as encompassing all follow-up imaging.

In considering questions 2 through 5, it is critically important to look at the conclusions of the external technology assessment (TA). As noted in the decision memo, the researchers from the University of Alberta Evidence-based Practice Center (UA-EPC) found that:

Dear Dr. Phurrough:

We are writing in response to the Centers for Medicare & Medicaid Services’ (CMS) request for comments on its proposed decision memorandum revising the current coverage determinations for oncologic FDG-PET imaging.

This letter is submitted jointly on behalf of the National Oncologic PET Registry (NOPR) Investigators, the American College of Radiology (ACR), the Academy of Molecular Imaging (AMI), the American Society for Radiation Oncology (ASTRO), the American College of Nuclear Physicians (ACNP), and the Society of Nuclear Medicine (SNM). These groups collectively are composed of clinicians, academicians, researchers and nuclear medicine providers utilizing molecular imaging technologies, including integrated positron emission tomography/computed tomography (PET/CT). We represent tens of thousands of physicians, providers, and patients with regard to this technology, and have worked closely with CMS over the past three years to increase beneficiary access to PET/CT through the development of the National Oncologic PET Registry (NOPR).

We wish primarily to voice our collective and strong support for the proposed decision overall. The articulation of a new, streamlined coverage framework (distinguishing the categories of “initial treatment” and “subsequent treatment”) is a significant improvement upon the previous four-category coverage framework, and we appreciate the efforts of CMS to develop a comprehensive omnibus framework that will minimize the need to seek indication-by-indication coverage decisions in the future. We are also supportive of the decision of CMS to provide coverage for initial treatment for nearly all oncologic indications that were covered previously only under the coverage with evidence development (CED) rubric. Additionally, we support the decision to maintain coverage for nine oncologic indications (breast, cervix, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid cancers) that, although not included in the NOPR, were covered under prior individual decisions.

While we applaud the proposed decision in general, there are several aspects of the proposed memorandum that we believe would benefit from clarification and revision by CMS in its final decision.

First, while we support the expanded PET coverage proposed by CMS, we continue to believe that the research data and existing literature supports full coverage for PET for all oncologic indications in the new category of “subsequent treatment,” and encourage CMS to expand coverage in this regard in the final rule. In particular, we note that in the case of ovarian cancer, both the CMS Technology Assessment and the data from the NOPR indicated the significant clinical value of PET. Indeed, use of PET in ovarian carcinoma for detection of suspected recurrence, treatment monitoring, and restaging represented the three most frequent indications for PET under the NOPR program. For suspected recurrence and restaging, PET led to a change in intended management (treatment to non-treatment or vice versa) in 44.5% and 37.7% of cases, respectively When used for treatment monitoring, PET led to a planned adjustment in the dose or duration of therapy, change to another therapy, or switching to supportive care in 53.5% of cases. We therefore encourage CMS, at a minimum, to extend non-CED coverage to subsequent treatment evaluations of ovarian cancer.

Second, if the final decision does continue CED for certain cancers and indications, we strongly encourage CMS to ensure that beneficiaries continue receiving uninterrupted access to PET during the implementation of the new NCD. We understand that once the final decision becomes effective, new CED studies—accommodating the additional AHRQ requirements—will be required. We also understand that it is highly unlikely that such studies will be operational at the time the final decision becomes effective. Thus, while we support the efforts to expand data collection regarding the impact of PET on health outcomes, we also believe it is crucial to avoid creating an abrupt “coverage gap” for cancer patients in the process. The existing NOPR study meets many, but not all, of the new AHRQ requirements, and we believe that the NOPR could be expanded to fulfill the outcomes-based requirements of the proposed decision. We are actively examining various design options (such as linking CED data to Medicare claims data in order to measure and evaluate outcomes) that would help achieve this objective. We welcome the opportunity to work closely with CMS, AHRQ and other stakeholders both to establish a transitional mechanism that would ensure uninterrupted PET access, and to develop a robust CED framework that meets the specifications of the final decision.

However, given the operational capacity of the existing NOPR, we do not believe that it is possible for the NOPR itself to fully transition to the requirements of the new CED long-term outcomes study within the available timeframe between the proposed and final decisions. We are not aware of any other organization or entity that has the capacity to develop and implement a fully-compliant CED study within this timeframe. Thus, in order to avoid inadvertently creating a PET “coverage gap” between the finalization of the NCD and the full implementation of any new CED study, we propose to work with CMS and AHRQ to amend the existing NOPR protocol in a manner that would enable beneficiaries to continue receiving PET coverage under a transitional study vehicle while a long-term outcomes study is being finalized.

Third, we request that CMS clarify whether it considers multiple myeloma to be a “solid tumor” for purpose of this NCD. The literature points to excellent sensitivity for detection of both osseous and soft-tissue lesions of myeloma, and the NOPR data demonstrate that PET frequently influences intended patient management in myeloma. We urge CMS to treat myeloma as a solid tumor (analogous to its classification of other lymphomas, to which it is closely related), rather than a “liquid” hematologic neoplasm.

Fourth, although the streamlining of the coverage framework into “initial” and “subsequent” treatment is a positive development, we encourage CMS to recognize in the final decision that—in certain clinical situations—the one-time-only availability of PET for “initial” treatment evaluation (for each new cancer diagnosis) may hamper good clinical practice. Two practical scenarios illustrate this general concern. First, where PET is used for diagnosis or initial staging purposes, the result may indicate that radiation therapy, rather than surgery, is the appropriate method of treatment. In such situations, a second (initial) PET scan, often a limited study done under technically different conditions, may be needed for radiation therapy planning (e.g., for PET-based simulation). Second, in a small fraction of patients, PET used to evaluate a suspicious lesion (e.g., a pulmonary nodule) for cancer diagnosis can produce a false-negative result. If such patients are subsequently diagnosed with cancer, however, the prevailing standard of care is to use PET for initial staging prior to surgery, in order to exclude unresectable disease (because of the interval development of metastatic disease). In both of these illustrations, a literal interpretation of the proposed coverage framework prohibits coverage for this second scan, despite the fact that failure to perform a scan in these circumstances would be contrary to good clinical practice.

Scenarios such as those described above, in which more than one PET study is performed for either diagnosis or initial staging in a given subject, occurred quite infrequently for those cancers covered under the NOPR. Based on fully-consented NOPR data from May 2007 through December 2008, a total of 97,043 PET scans were performed. Of these, 16,766 were done for diagnosis and 21,134 for initial staging (total = 37,900), in a total of 36,959 patients. Thus, only 754 patients (1614 scans) — or 2.0% — had more than one scan during this interval for initial treatment evaluation (diagnosis and/or initial staging).

We therefore recommend that the final rule accommodate and cover clinically necessary “second initial” scans in situations such as those described above. One way to accomplish this objective would be through the use of HCPCS codes for these specific services. Providers currently use the CPT level I HCPCS codes to report all covered indications of PET/CT procedures. As one approach, for example, we recommend that CMS expand coverage and track utilization of second radiation planning scans by developing a HCPCS Level II temporary G code G02xx "PET/CT Imaging, radiation therapy planning, subsequent to initial PET or PET/CT study."

Again, we wish to reiterate our support for the new framework developed by CMS, and to express our appreciation for the efforts CMS has made to expand oncologic PET coverage to its Medicare beneficiaries. We appreciate the opportunity to comment on this proposed decision memorandum, and look forward to providing CMS with any additional information that would be of value in this regard.

Sincerely,

/S/
Bruce E. Hillner, MD
Chair, NOPR Working Group

/S/
Harvey L. Neiman, MD, FACR
Executive Director, ACR

/S/
Timothy McCarthy, PhD
President, AMI

/S/
Laura I. Thevenot, CAE
Chief Executive Officer, ASTRO

/S/
Hazem Chehabi, MD
President, ACNP

/S/
Robert W. Atcher, PhD, MBA
President, SNM

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As a Nuclear Medicine physician, whose primary professional responsibility is reading PET scans, I can tell you from experience how vital they are. They not only are one of the best (if not THE best in circumstances) evaluation tool we have, for the reimbursable indications, but I have also found many other "incidental" findings and tumors, which would not have been found otherwise. This has lead to a multidisciplinary approach to patients, to erradicate their malignancies; having lead to a better quality of life, safer treatment, and a cost savings to patients and the system by addressing multiple issues at once.

In fact the real shame is that in today’s litiginous society, physicians are afraid to read the CT portion for findings for fear of lawsuits, even though they often provide vital information, and are not reimbursed (why accrue significant additional liability without pay. These scans add a noncontrasted nondiagnostic “screening” CT of the base of the brain, neck, chest, abdomen, pelvis and proximal legs). I myself often comment on these significant findings. Yes, there are a few drawbacks of the PET exams, but as one of the better modalities on the cancer frontlines, we should be talking about how do we improve, not curtail, it’s ability and use.

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To whom it may concern,

As a urologist practicing at a National Cancer Institute Comprehensive Cancer Center, I applaud CMS’ intent to provide expanded coverage for PET for initial evaluation of many cancers that previously were covered under a coverage with evidence development program, by inclusion in the National Oncologic PET Registry. I further encourage CMS to ensure that there is no gap in coverage for subsequent treatment evaluations of these cancers, and to find a pathway to broad coverage of PET for all cancers and indications, thereby allowing oncologic specialists to have the latitude in use of PET that they have with other imaging methods. In addition to many Medicare beneficiaries to have access to PET since 2006 and providing much useful data on the impact of PET on referring physician’s intended management plans, the NOPR also has had an additional benefit, by allowing investigators at academic institutions such as mine to use PET in clinical practice while gathering more complete outcomes data to assess the impact of PET on patient management. An example from my institution demonstrates the application of this additional benefit.

PET imaging has been increasingly used to augment conventional imaging for bladder cancer, but published studies on its accuracy have been quite limited (in part because of limited coverage for the procedure in patients with bladder cancer). Several years ago, we became interested in determining whether PET could identify occult metastatic disease in patients with muscle-invasive bladder cancer scheduled to undergo radical cystectomy. We undertook a single-institution prospective study and have enrolled 43 patients to date, all of whom had negative preoperative CT scans and bone scans (i.e., conventionally staged as having no locoregional or distant metastatic disease). We attempted to confirm all positive PET finding by biopsy AND did lymphadenectomies on all patients with negative PET. FDG-PET/CT demonstrated a positive predictive value for metastatic disease of 78% (7/9), a negative predictive value of 91% (30/33), sensitivity of 70% (7/10) and specificity of 94% (30/32). Recurrence-free survival, disease-specific survival, and overall survival were all significantly better in the patients with negative FDG-PET/CT studies for metastatic disease than in those with positive FDG-PET/CT. These findings have profound clinical implications, indicating that patients with positive PET scans should be treated with neoadjuvant chemotherapy prior to cystectomy or even be spared cystectomy. We are going to present our results at the National American Urologic Association Meeting this spring, and are preparing our results for publication. Our study included a spectrum of patients, but many of them were Medicare beneficiaries. This study would not have been possible without our being able to perform in the Medicare beneficiaries under the NOPR.

A continuation of CMS’ coverage with evidence development program for PET is likely to reap additional benefits beyond the program’s primary goals, as our example illustrates.

Adam Kibel, MD
Professor of Surgery
Siteman Cancer Center
Washington University School of Medicine

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Houston, February 3, 2009

Dear Sir or Madam:

I would like to submit my feedback regarding the proposed expansion of coverage for PET/CT scans in cancer patients. I firmly agree that the coverage of PET/CT scans ought to extend to all tumor types in the initial treatment period. As a medical oncologist, I routinely use PET/CT scans in my practice, especially when conventional imaging modalities such as CT, MRI and bone scans frequently fail to provide adequate information regarding my patients' conditions. As my experience with PET/CT has increased, so too has my utilization. I have found on numerous occasions that the results from the staging PET/CT scan identified more extensive disease than what was previously suspected on multiple conventional imaging modalities combined. This has led to the avoidance of surgeries and other localized treatments that would have proven futile (and expensive) for patients who instead required systemic therapies in order to address all sites of disease. In the absence of PET/CT, pursuing localized treatments only to find out that such courses of action are incongruous with the true stage of disease delays the onset of critical systemic therapies and can have a deleterious impact on patient outcome. As well, PET/CT may exclude the presence of disease, which was suspected based on conventional imaging modalities, again allowing more appropriate treatment decisions. PET/CT frequently replaces multiple imaging modalities, saving my patients time, radiation exposure, costs and inconvenience associated with undergoing multiple tests. Due to its increased accuracy, the information provided by whole-body PET/CT helps to ensure that each of my patients is on the correct path of treatment for his or her condition.

While the proposal that includes coverage for PET/CT scans in the initial treatment setting is a step in the right direction, it falls short by not including coverage for PET/CT scans for all solid tumors in the subsequent treatment period as well. The radiographic assessment in cancer patients critically rely on utilizing the same imaging techniques and tools at baseline and posttherapy. While imaging modalities such as CT scans and MRls have an unquestionable use in medicine, the assessment of metabolic modulation induced by anticancer therapies is of pivotal importance to evaluate treatment efficacy, especially in the setting of new targeted treatment approaches. Overall, using PET/CT in the subsequent treatment setting can shorten the time it takes to identify whether my patients are responding to therapy andfor whether they are relapsing. The information provided by PET/CT has proven to be more accurate than that of multiple conventional imaging modalities and significantly impacts patient management for the majority of cancer diagnoses. Finally, I would also like to highlight the importance of PET/CT scans in patients with borderline renal function or at high risk for renal insufficiency while receiving nephrotoxic therapies (i.e. diabetes, hypertension, etc.)

I thank you for proposing expanded coverage in the initial treatment setting and encourage you to re-visit your proposal to include PET/CT coverage for the subsequent treatment period as well.

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Feb. 3, 2009

To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent ofthe disease and determining an appropriate course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction. However, from my perspective, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans by the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is vitally important that I am able to order a PET/CT scan in the treatment planning position- the same exact position in which the patient will receive daily treatments. Some of these patients may have undergone surgery and/or chemotherapy since their initial scan. A PET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior) provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.

2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et al 2003). In my practice, I have seen patients with cancers which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.

3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post-therapy changes are very difficult to differentiate from active disease on a CT alone; however, PET/CT allows me to do just that. I cannot use an inferior imaging modality which will often be indeterminate to decide whether or not my patients require salvage treatments which may impact their overall survival. One of the key advantages of PEl/CT is the ability to assess residual or recurrent disease 2-3 months sooner than conventional imaging. For a patient with cancer, this time is crucial.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but I am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

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Feb. 3, 2009

To Whom it May Concern:

Re: PET/CT Coverage

As a Radiation Oncologist, I find that PET/CT is a vitally important tool for radiation treatment planning. The initial staging scans are critical for defining the true extent of the disease and determining an appropriate course of action. I fully support CMS' assessment that PET/CT scans should be covered in the initial treatment of all solid tumors and am pleased at this step in the right direction. However, from my perspective, the current guidelines do not cover many of the situations for which I find PET/CT most useful.

1. Patients have often already had PET scans by the time they come to see me (e.g. ordered by medical oncologists, surgeons). Once I consult with a patient and establish the treatment modality and positioning equipment to be used, it is vitally important that I am able to order a PET/CT scan in the treatment planning position- the same exact position in which the patient will receive daily treatments. Some of these patients may have undergone surgery and/or chemotherapy since their initial scan. A PET/CT in the treatment planning position at the time that I am actually delivering the treatment (rather than a scan from several weeks or months prior) provides information that helps me to more precisely define appropriate radiation fields as well as rule out disease that may have developed in the interim.

2. The current clinical literature supports that the integration of PET/CT for treatment planning leads to a change in the gross tumor volume in as many as 56% of cases relative to CT scans across multiple cancer diagnoses (Ciernik et al 2003). In my practice, I have seen patients with cancers which, on CT, had no nodal involvement but on PET/CT had subcentimeter lymph nodes that were positive. In these patients, without PET/CT, I would not have treated the lymphatics as aggressively. In other situations, the treatment area as defined by the CT is considerably larger than the actual tumor. PET/CT is able to help identify the true extent of disease so that I can plan accordingly to maximize the dose to the tumor while minimizing exposure of healthy tissues.

3. Most of my patients undergo treatment for several consecutive weeks. Afterwards, I must have an accurate imaging tool to help me assess the response to therapy. Post-therapy changes are very difficult to differentiate from active disease on a CT alone; however, PET/CT allows me to do just that. I cannot use an inferior imaging modality which will often be indeterminate to decide whether or not my patients require salvage treatments which may impact their overall survival. One of the key advantages of PET/CT is the ability to assess residual or recurrent disease 2-3 months sooner than conventional imaging. For a patient with cancer, this time is crucial.

PET/CT should be available to oncology specialists whenever there are important clinical decisions to be made. It is a vital imaging tool for patients with cancer throughout the course of their management. I applaud the progress that CMS has made in expanding coverage for initial treatment decisions, but I am hopeful that you will also consider further expanding coverage for guiding the treatment decisions that occur during the subsequent treatment phase.

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As a Radiation Oncologist who has been using PET CT fusion for treatment planning since 2000 and co-authored peer reviewed publications on the subject I would like to submit my support to the use of functional imaging in the diagnosis and treatment of solid tumors. It adds significant information to anatomical diagnosis, spares local therapies to patients who have disseminated disease and provides invaluable prognositic and therapeutic evaluation data, eliminating unnecessary biopsies and or surgical procedures after non invasive therapies.

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Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R))

Dear Dr. Phurrough,

International Myeloma Foundation thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to comment on the draft decision memorandum on Medicare coverage of Positron Emission Tomography (PET) for cancer. We are writing to voice our general support of the framework outlined in the draft decision memo, but also would like to highlight several concerns that we urge CMS to address in its final coverage decision.

The International Myeloma Foundation (IMF) is a national nonprofit organization dedicated to fighting myeloma, which impacts close to 100,000 individuals and families throughout the United States. Since 1992, the IMF has engaged in a wide range of activities to raise awareness of myeloma and ensure that those suffering from myeloma have access to the most effective medical technologies and treatments. FDG-PET is particularly helpful in the evaluation of multiple myeloma. In the most recent NOPR publication, myeloma was identified as having the greatest likelihood of change in management (48.7%) based upon PET results. Across testing indications only in myeloma did PET have a consistently greater impact on intended management. Thus the role of PET in myeloma increasingly resembles the extremely useful role in lymphomas which is an already approved indication. For this reason we urge CMS to treat myeloma as a solid tumor (analogous to its classification of lymphomas to which it is very closely related) rather than as a liquid hematologic neoplasm. See embedded reference at end of letter.

We recognize the complexity of making evidence-based coverage decisions and for that reason appreciate CMS’s Coverage with Evidence Development (CED) approach to gather additional data through the National Oncologic PET Registry (NOPR) on the use of PET for cancer.

As you are aware, the analysis of the CED-collected data published by the NOPR Working Group in the Journal of Clinical Oncology (JCO) and in other peer-reviewed publications demonstrates that PET provides physicians with important information for developing treatment plans tailored to the needs of individual cancer patients. According to the JCO article, based on review of nearly 23,000 PET scans across the nation, the NOPR study determined that PET led to a change in the initial treatment approach in more than one-third of all cases in which it was employed. Moreover, where the pre-PET treatment plan was biopsy, PET led to a decision to avoid surgical intervention seventy-five percent of the time, a more cost-effective option.

We understand that under the proposed decision framework, CMS intends to transition from coverage for “diagnosis”, “staging”, “restaging,” and “treatment monitoring” for certain cancers, to coverage for PET based on guiding “initial treatment strategy” (which encompasses diagnosis and staging) and “subsequent treatment strategy” (which encompasses restaging and treatment monitoring). While we recognize the limitations of the NOPR data in linking the use of PET to patients’ long-term clinical outcomes, we nonetheless believe that this diagnostic tool has significant implications in determining the right course of treatment for many cancer patients. Accordingly, we strongly support CMS’ proposed decision to lift the CED requirements and allow Medicare coverage of one PET scan to guide the “initial treatment strategy” for cancer patients with a confirmed or strongly suspected diagnosis of solid-tumor cancer. We also appreciate that CMS will continue to provide full coverage for PET across all indications, including to guide “subsequent treatment strategies” for the nine cancer types (breast, cervix, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, and thyroid) which were not part of NOPR, but which were granted coverage in prior, separate National Coverage Determinations (NCD).

However, we do have several concerns with the draft decision framework. First, under the proposed decision, CMS would provide coverage for PET to guide “subsequent treatment strategies” only if the beneficiary is enrolled in a clinical study pursuant to a CED framework which meets certain listed criteria. To ensure continued patient access to PET scans, it is essential that after finalization of the NCD, there is no interruption in coverage of PET for subsequent treatment strategies. The NOPR could be discontinued when the NCD is final, thus we hope CMS will transition to a new CED framework immediately after finalization of the NCD to allow patients seamless, timely access to PET to provide critical information to help guide their treatment.

Second, we urge CMS to reconsider providing full coverage, without CED requirements, for additional cancers. Particularly for cancers for which there are very few diagnostic options to aid the physician in developing a course of treatment or in monitoring recurrence and follow-up treatment, PET is a significant addition to the toolbox, as the NOPR data show. We encourage CMS to take this into account when issuing the final decision. For myeloma, full coverage is recommended as for lymphoma since the clinical utility is essentially identical.

We appreciate the opportunity to comment on the draft decision memo and would be pleased to provide CMS with any additional information that may be valuable. Should you have any questions, please feel free to contact me (see below for contact information). We look forward to the final NCD and thank you for your consideration of our comments and concerns.

See Reference: Hillner BE, Siegel BA, Shields AF, et al. Relationship between cancer type and impact of PET and PET/CT on intended management: Findings of the National Oncologic PET Registry. J of Nuc Med. 2008;49(12):1928-1935.

Sincerely,

Brian GM Durie, MD
Chairman of the Board of Directors
International Myeloma Foundation
National Director for Hematologic Malignancies and Multiple Myeloma, Aptium Oncology, Inc.
Co-Chair Myeloma Committee- SWOG
Specialist in Multiple Myeloma and Related Disorders,
Cedars-Sinai Outpatient Cancer Center
8201 Beverly Boulevard
Los Angeles, CA 90048
Tel: 323-966-3572
Fax: 323-966-3685
bdurie@aptiumoncology.com

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For 15 years I have seen women and their doctors wrestle with making decisions about treatment for recurrent ovarian cancer. Rising ca125s were often used for determining the resumption of cytotoxic treatment because often recurrent ovarian cancer resembles grains of sand which are not big enough to pick up on a CT scan. About 10 years ago PET scans became available, but while they were better about picking up smaller lesions, there was too much "noise". Recently the PET/CT has been added to the arsenal of tools that can help women and their doctors determine if a women is truly having a recurrence, but unfortunately, because of cost, this tool is not available. Women with ovarian cancer have been fighting for over 10 years to have scans covered by insurance and Medicare. A low incidence cancer with a high death rate doesn''t have the opportunity to run many large scale trials, yet when the NOPR registry was open, women flocked to the registry to get their scans. They and their doctors were happy to have an avenue so these scans could be paid for and intelligent medical decisions could be made for their patients. The number of scans on ovarian patients exceeded all but prostate cancer in the registry. Ovarian cancer patients and their doctors have to make hard decisions about treatment. How much cancer the patient has and where it is, is critical in determining when to treat and what to use. While recurrent ovarian cancer is not curable, it is highly treatable and many of our women are living 10 or even 15 years with good quality of life. However, that is dependent upon making appropriate treatment choices at appropriate times. I urge you to allow women with recurrent ovarian cancer to have coverage for these scans now. It is critical to the decision making process that is so important to these women''s lives.
Sincerely,
Diane Paul

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To: CMS Re: Proposed Decision Memo for PET for Solid Tumors

At Anne Arundel Medical Center in Annapolis, Maryland, we have participated fully with the National Oncologic PET Registry, and I would like to offer a comment on the proposed CMS decision memo for Positron Emission Tomography for Solid Tumors (CAG-00181R).

During the course of the trial, we performed approximately 200 PET/CT examinations under the NOPR. These cases were associated with a total of 52 diagnostic codes for neoplasms which were otherwise not covered by CMS guidelines. The most frequent use was for carcinoma of the ovary, carcinoma of the cervix, uterus, and bladder. There was a broad variety of other malignant tumors investigated, including cases from the appendix, anus, pylorus, stomach, liver, gall bladder, pancreas, peritoneum, pleura, soft tissue, skin, adnexa, vagina, vulva, prostate, testicle, kidney, eye, thyroid, lymph nodes, thymus, neurohypophysis, pericardium, and others.

In almost all cases, excellent studies were obtained and contributed to clinical management and treatment of these Medicare enrollees. Many of these patients would need this study clinically, and would have had to pay out-of- pocket for this examination, which has been shown to be of value in numerous oncologic indications, and is being requested increasingly by oncologists.

For these reasons, I applaud the proposed decision to make PET available for “Initial Treatment Strategy” for all suspected solid tumors. The omission of approval for prostate carcinoma, initial breast cancer diagnosis, and regional lymph node involvement in melanoma, is also quite reasonable, since the technique has not been accurate for those indications.

Continued support for follow-up examinations for “Subsequent Treatment Strategy” is well warranted, particularly for the nine previously covered indications. The exam will no doubt be proven valuable in follow-up for most, if not all, of the other solid tumors as well.

Thank you for your consideration.

Jack Van Geffen, M.D. Director, Nuclear Medicine January 30, 2009

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I agree completely with your decision to change the framework combining Diagnosis and Initial Staging into one category while combining Restaging and Therapy Monitoring into another. A very good decision.

I agree completely with the expansion of coverage in Initial Treatment Strategy to virtually all solid tumors (with the four noted exceptions).

I do, however, strongly disagree with the decision to not expand the use of PET in Subsequent Treatment Strategy beyond the nine cancers currently covered. It makes no sense whatsoever to allow the use of PET for the Initial Staging of, say Ovarian cancer, but not allow PET in the subsequent restaging of that same patient. It PET would be helpful the first time, it stands to reason that it would be helpful the second.

Please look at it from the physician’s perspective. In the initial staging of a patient, why would a physician order a PET? Because he/she felt that traditional imaging (CT, MR, etc.) was not sufficient to provide all of the information necessary to properly stage the patient. If the physician felt the traditional imagery was sufficient, obviously they would not order the PET. So considering this same patient, if traditional imagery was insufficient to properly stage the patient initially, why would it suddenly be good enough to restage the patient?

Cancers don’t change. In most cases, an ovarian cancer will be found on PET and it will be found regardless of the ordering rationale – Initial or Subsequent. Prostate cancer probably will not be found on most PETs, again, regardless of the reason.

When looking at specifics, you actually have it backwards in certain circumstances. Take primary brain cancer, for instance. It is widely understood that MR is superior to PET in the initial staging of primary brain cancer. Yet you are approving the use of PET in initial staging. It is also widely understood, that in restaging brain cancer after radiation, in a situation where there are morphologic changes, PET is far the superior to MR in differentiating radiation necrosis vs. recurrent tumor. Yet you are not approving PET to restage brain cancer.

In summary, I strongly approve of most of the changes you are making to the Medicare coverages for PET. But I strongly disagree with the decision to not extend coverage for PET in restaging patients past the current nine cancers.

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After reading your policy I have very happy that you are planning on lifting the CED requirements to allow Medicare coverage of one PET scan to guide the initial treatment of cancer patients. [PHI Redacted]

I would like you to consider the need for a mechanism to proide coverage for multiple inital treatment studies on patients undergoing radiation therapy.

I feel it is important to avoid a cerage gap after the finalization of the NCD to ensure continued patient access to FDG-PET scans for subsequent treament strategies. I would like to see CMS work with PET providers, physicians and others to quickly approve a new CED framework immediately after the NCD is finalized.

I would also like CMS to reconsider providing full coverage, without CED requirements, for cancers for which the NOPR data are especially strong. This would be particularly for cancers for which there are few diagnostic options to aid the physician in developing a coarse of treatment or in monitoring recurrence and follow- up treatment; FDG-PET is a significant addition to the clinician toolbox, as sthe NOPR data show.

Finally I''d like to thank CMS for continuing to provide full coverage for PET across all indications, including the guidance of "subsequent treatment strategies" for the nine cancer types previously covered by CMS

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I agree completely with your decision to change the framework combining Diagnosis and Initial Staging into one category while combining Restaging and Therapy Monitoring into another. A very good decision.

I agree completely with the expansion of coverage in Initial Treatment Strategy to virtually all solid tumors (with the four noted exceptions).

I do, however, strongly disagree with the decision to not expand the use of PET in Subsequent Treatment Strategy beyond the nine cancers currently covered. It makes no sense whatsoever to allow the use of PET for the Initial Staging of, say Ovarian cancer, but not allow PET in the subsequent restaging of that same patient. If PET would be helpful the first time, it stands to reason that it would be helpful the second.

Please look at it from the physician’s perspective. In the initial staging of a patient, why would a physician order a PET? Because he/she felt that traditional imaging (CT, MR, etc.) was not sufficient to provide all of the information necessary to properly stage the patient. If the physician felt the traditional imagery was sufficient, obviously they would not order the PET. So considering this same patient, if traditional imagery was insufficient to properly stage the patient initially, why would it suddenly be good enough to restage the patient?

Cancers don’t change. In most cases, an ovarian cancer will be found on PET and it will be found regardless of the ordering rationale – Initial or Subsequent. Prostate cancer probably will not be found on most PETs, again, regardless of the reason.

When looking at specifics, you actually have it backwards in certain circumstances. Take primary brain cancer, for instance. It is widely understood that MR is superior to PET in the initial staging of primary brain cancer. Yet you are approving the use of PET in initial staging. It is also widely understood, that in restaging brain cancer after radiation, in a situation where there are morphologic changes, PET is far the superior to MR in differentiating radiation necrosis vs. recurrent tumor. Yet you are not approving PET to restage brain cancer.

In summary, I strongly approve of most of the changes you are making to the Medicare coverages for PET. But I strongly disagree with the decision to not extend coverage for PET in restaging patients past the current nine cancers.

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Thank you for the proposed expansion of PET coverage for many types of malignancies. I would like to see further coverage for restaging and therapy monitoring for patients with testicular, small cell lung, pancreatic, esophageal, and ovarian cancer. For metastatic testis cancer, current standards of care mandate surgical resection of residual disease after initial therapy, which is often technically difficult, potentially dangerous, and costly. For the other diagnoses as well PET for assessment of treatment response can spare patients further biopsy, surgery, and anxiety over uncertainty of their disease status. With performance of fewer invasive procedures, I suspect that overall financial burden to CMS will be improved in addition to providing safer, more effective care to our patients.

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As a nuclear medicine physician working in one of the National Comprehensive Cancer Network institutions, I have seen so many patients benefit from PET studies. And also seen the difficulties to get approval for non covered cancer indications.

NOPR provided a great pathway for people to get the scan and change their management. I fully support the CMS proposed expansion for coverage, and would like to see the continuation of NOPR for non covered cancers to provide essential service and collect more data for CED.

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In principle, PET Scans are a vital and efficient tool in the diagnosis, staging and follow up management of Thoracic Malignancies. I think PET Scans are a useful tool in assessing response to treatment in patients with NSCLC both in stage IV disease and in stage III disease after treatment with chemotherapy and radiation therapy. In Stage III disease, after definitive chemotherapy and radiation therapy often there is a residual mass. PET Scan is a useful tool to help differentiate this mass from scar tissue versus viable tumor. In Stage IV disease, PET scans and help in evaluating treatment follow up for NSCLC, especially in patients treated with EGFR-TKIs since PET Scans can demonstrate treatment response relatively quickly.

PET scans, based on the available literature are an efficient staging modality for SCLC as well. SCLC have an early propensity to metastasize and therefore PET Scan is a very useful tool in ensuring the Limited stage SCLC are really limited and extensive stage SCLC are really extensive. The high false positivity rate with bone scans can in some situations may make determining the true stage in SCLC challenging. PET Scans, in my opinion, could also be a useful tool in assessing response to treatment, as well, particularly in the limited stage setting.

Mesotheliomas can often be difficult to differentiate from reactive mesothelial disease or asbestos related pleural plaquing. PET Scans could aid in differentiating this. Additionally it can aid in staging the disease and determining whether there is invasion into the mediastinum and therefore determine whether the disease is operable or not.

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Thank you for the opportunity to comment on the proposed CMS coverage rules for PET. As highlighted in my August 2008 presentation to CMS, NOPR data and a number of other publications cited in the presentation strongly support the utility of PET for staging in the cancers that were included in the NOPR. I therefore strongly support the CMS decision to provide coverage for FDG PET/CT for initial treatment evaluation. I would also like to add that the NOPR data and cited publications also supported the use of FDG PET/CT for re-staging many of the cancers that were under investigation in NOPR. This would come under the heading of subsequent treatment evaluation in the proposed coverage decision, which is apparently slated for a future CED in the CMS proposal. I think CED for subsequent treatment decisions will provide valuable data. However, given the importance of FDG PET/CT re-staging for many of the affected cancers in current clinical practice, and the utility of PET/CT in early published studies, I strongly urge CMS to be sure that coverage does not lapse during the transition from the current CED under the NOPR to the new CED for subsequent treatment evaluation.

I would like to comment on two areas of application that I am particularly familiar with: breast cancer and thyroid cancer. For breast cancer, current CMS guidelines provide coverage for staging and re-staging recurrent or metastatic breast cancer and response evaluation. As reviewed in recent overview publications from our center (for example, Rosen EL, Radiographics. 2007 Oct;27 Suppl 1:S215-29), these applications have become an essential part of current breast cancer practice. Our data, first published in 2001, showed that FDG PET, detected sites of disease not seen by standard imaging, and that the PET results changed staging form localized disease to more widespread disease (Eubank, Clin Oncol. 2001 Aug 1;19(15):3516-23), resulting in a substantial change in management in close to 40% of patients with recurrent or metastatic disease (AJR Am J Roentgenol. 2004 Aug;183(2):479-86.). Subsequent studies have confirmed the utility of FDG PET and PET/CT in staging or re-staging recurrent or metastatic breast cancer (reviewed in Rosen EL, Radiographics. 2007 Oct;27 Suppl 1:S215-29 and Benard, Breast Cancer Res. 2005;7(4):153-62.) and showed improved performance for FDG PET/CT versus FDG PET (Fuger, Mol Imaging Biol. 2005 Sep-Oct;7(5):369-76.) Consensus guidelines from a recent NCCN panel recommended FDG PET and PET/CT as useful and important adjunct for staging and re-staging recurrent or metastaic breast cancer (Podoloff, Natl Compr Canc Netw. 2007 May;5 Suppl 1:S1-S22). In addition to this indication, the panel recommended FDG PET for initial staging of locally advanced or large breast cancers (advanced Stage II or Stage II breast cancer) as a promising area that should be reviewed again as more data emerge. A flurry of recent publications strongly support FDG PET and PET/CT for this indication, specifically to identify extra-axial lymph node metastase and distant metastases in patients presenting with large primary tumors and./or clinically positive axillary nodes (Fuster, J Clin Oncol. 2008 Oct 10;26(29):4746-51; Groheaux, nt J Radiat Oncol Biol Phys. 2008 Jul 1;71(3):695-704; Cermick, Eur J Nucl Med Mol Imaging. 2008 Mar;35(3):475-83; Klaeser, Ann Oncol. 2007 Aug;18(8):1329-34; Veit-Haibach, Br J Radiol. 2007 Jul;80(955):508-15). The application to locally advanced breast cancer was highlighted in a recent NIH state-of-the-science conference (Chia, J Clin Oncol. 2008 Feb 10;26(5):786-90). The current data therefore strongly support continuing the currently CMS-covered use of FDG PET/CT for staging or re-staging of recurrent or metastatic breast cancer and suggest expanding coverage to initial staging of large or locally advanced breast cancers.

Data continue to support the currently CMS-covered use of FDG PET and PET/CT to monitor breast cancer response to therapy. In particular, for locally advanced breast cancer treated by pre-surgical chemotherapy, FDG PET provides an indication of response and prognosis that is independent of and complementary to other established markers (Emmering, Ann Oncol. 2008 Sep;19(9):1573-7; Dunnwald, J Clin Oncol. 2008 Sep 20;26(27):4449-57). Such information is key in making decisions about subsequent treatment (Chia, J Clin Oncol. 2008 Feb 10;26(5):786-90). FDG PET and PET/CT are also increasingly used to monitor the response of bone-dominant breast to therapy, where few other options exist. Publications support the accuracy of FDG PET and PET/CT in this approach, and its ability to predict disease progression and the need for alternative treatment (Stafford, Acad Radiol. 2002 Aug;9(8):913-21; Specht, Breast Cancer Res Treat. 2007 Sep;105(1):87-94; Tataeishi, Radiology. 2008 Apr;247(1):189-96; Du, J Clin Oncol. 2007 Aug 10;25(23):3440-7). These data and the current clinical need strongly support continued CMS coverage of FDG PET and PET/CT to measure breast cancer response to therapy.

Finally, as a physician with a large practice in the treatment of thyroid cancer, I urge you to continue current CMS of FDG PET/CT for the evaluation of iodine-refractory thyroid cancer. Patients who have evidence of residual or recurrent thyroid cancer by markers or other imaging, but who have negative radioiodine scans, present an important clinical dilemma, for which FDG PET/Ct play an absolutely essential role. As highlighted in recent reviews (Robbins, Best Pract Res Clin Endocrinol Metab. 2008 Dec;22(6):1047-59; Iagaru, Clin Nucl Med. 2007 Sep;32(9):690-5), PET identifies sites of disease in over 60% of patients and has a significant impact upon the choice of further treatment. Perhaps most importantly, since the absence of FDG uptake strongly portends a favorable outcome (Robbins, J Clin Endocrinol Metab. 2006 Feb;91(2):498-505) , the application of PET to refractory thyroid cancer allows us to decide when further treatment of patients with known or suspected recurrent disease is NOT indicated, sparing patients unneeded treatment unlikely to provide benefit. These data have also supported the use of FDG PET and PET/CT to select patients with iodine-refractory thyroid cancer for clinical trials of novel, alternative therapy. We presented the early results of such a trial at the 2008 ASCO meting (Gouart, ASCO, 2008), showing a high rate of response to sunitinib in PET-selected patients. FDG PET and PET/CT are essential to the current and future practice of thyroid cancer, and I strongly urge CMS to continue the current coverage of PET for iodine-refractory thyroid cancer.

My thanks again for the opportunity to comment on the proposed coverage decision.

David Mankoff, MD,PhD
Professor of Radiology, Medicine, and Bioengineering
University of Washington and Seattle Cancer care Alliance

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I want to share some comments on the value of PET scans in caring for my patients with cancer.

I take care of a 72 yo gentleman who presented with an undifferentiated cancer in his lung. CT scans, bone scan and brain MRI were negative for disease outside the lung. He was scheduled for mediastinoscopy and possible lobectomy, but we arranged a PET scan first. This revealed suspicious uptake in multiple abdominal lymph nodes and a high neck node, not seen on CT scans. Biopsy has confirmed metastatic malignancy. Although we still do not know the source of this undifferentiated malignancy, despite sending the tumor to Mayo Clinic for second opinion, we have prevented this gentleman from undergoing unnecessary lobectomy by determining that the cancer is unfortunately widely metastatic.

I follow a second patient with a ho ovarian cancer who now has an elevated Ca125 tumor marker. CT scans are negative for recurrence. She is having a PET scan on the registry to determine whether she has potentially resectable disease for which surgery could potentially be curative, or life extending.

Both of these PET scans would be limited to the CED category in the expanded PET coverage PDM. I am concerned that both of these patients would not have coverage for PET scans if the PET registry is threatened.

The responsible use of PET scans in many of my patients with cancer has improved their quality of life and can ultimately decrease expense by avoiding unnecessary surgery.

I applaud the expanded coverage proposed, but remain concerned that limiting the use of repeat scans to one scan in retreatment can be harmful.

I take care of a 68 yo woman with high risk rectal cancer who was rx''d with adjuvant chemoradiation. CT scans showed new lymph node enlargement. None of the nodes was easily accessible to biopsy.PET scan showed an intensely hot inguinal node not abnormal on CT. Biopsy revealed a potentially curable lymphoma. She starts lymphoma rx next week. She had already had a PET scan to restage her rectal caner two years ago, and the current PET may not have been covered in the proposed nerw guidelines.

Thank you for your consideration. While I could try to quote the literature for you, I am sure many experts have done that already. These three patients are not in the literature, but represent the patients with cancer I see every day for whom I want to try to continue to deliver the best and smartest care.

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January 27, 2009

Steve Phurrough, MD, MPA
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid
7500 Security Blvd, Mail Stop
Baltimore, MD 21244
C1-09-06

Re: Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG 00181R)

Dear Dr. Phurrough:

We are writing in response to the Centers for Medicare & Medicaid Services’ (CMS) request for comments on its proposed decision memorandum revising the current coverage determinations for oncologic FDG-PET imaging.

Shared Medical Services is a provider of FDG-PET imaging delivered in a mobile environment. We have provided service to well over 100,000 patients at 250 different medical facilities, building relationships with hundreds of primary and referring physicians, with regard to this technology. We have worked to provide over 600 patients access to care through the NOPR program.

We are in support of the proposed decision overall. The new coverage (developing the categories of “initial treatment” and “subsequent treatment”) is a significant improvement upon the previous four-category coverage. We also support the decision of CMS to provide coverage for initial treatment for nearly all oncologic indications that were covered previously only under the NOPR Program. We also support the decision to maintain the existing coverage for nine currently covered oncologic indications.

We encourage CMS to extend full coverage to the other cancers that are listed in the proposed rule as “Covered under CED”. We believe that the research data and existing literature supports full coverage for PET for all oncologic indications in the new category of “subsequent treatment,” and encourage CMS to expand coverage in this regard in the final rule.

We have an area of concern where the clinical data and CMS’ own Technology Assessment disagree with the proposed rule. This is in the case of ovarian cancer. Both the Technological Assessment and the NOPR data showed great clinical value for the use of FDG PET in the restaging and detection of recurrence of ovarian cancer. We would ask that CMS consider covering ovarian cancer for BOTH initial AND subsequent treatment.

We also support the continuation of Coverage with Evidence development for other non-covered indications. We encourage CMS to work with the medical societies and provide a good framework for collecting the needed data.

Thank you for opportunity to comment on the proposed rule, and thank you for providing a good thorough assessment of the published NOPR data.

Sincerely,

/S/

Lisa Arington
President & CEO

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As a medical oncologist at Siteman Comprehensive Cancer Center at Washington University in St Louis, I see 100 new patients with sarcoma yearly, and provide long term care for many more. In my experience, PET scans frequently provided important information about disease extent and about tumor response to chemotherapy or targeted therapy. The information provided by PET scans commonly added to that of CT scans, and in my experience changed the treatment plan in approximately 30% of patients. In sarcoma, recent clinical trials are confirming what our experience as clinicians have observed. That is, the use of CT scans to assess tumor response (by RECIST criteria) to either targeted therapy or chemotherapy correlates poorly with the true tumor response, and that PET scans provide more accurate information. Indeed, it is not unusual for a CT scan to initially show an increase in the size of a sarcomatous mass after a few cycles of chemo/targeted therapy (even when the patient''s clinical symptoms are better) but later show a decrease in the size of the same mass in spite of continuing with the same therapy. In such cases, the information yielded from PET scans performed concurrently show evidence of tumor response at both time points. The number of treatment options are limited for our patients. It would be tragic to stop an effective treatment based on a false result on a CT scan when we have a technology (PET) that is widely available and, in my opinion, more accurate in assesssing tumor response to therapy in this patient population.

I strongly recommend the following:

1. There should be no gap in coverage for subsequent treatment evaluation for cancers that are now covered under NOPR and will continue to be covered only via CED until a successor CED program can be implemented.

2. Sarcomas should be covered for subsequent treatment evaluation.

FDG-PET is an established cancer imaging method and it should be available for treating physicians to use as they deem necessary for management of their patients with sarcoma. FDG-PET does not perform uniformly in every type of cancer, but neither do CT and MRI— physicians such as I should be able to apply our knowledge and experience regarding the use of this important cancer diagnostic tool.

Thank you for supporting my patients.

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findings of restaging PET performed approximately 3 months after completion of chemoradiation therapy are strongly predictive of clinical outcome. CT nearly always show partial response in the primary tumor and regional nodes early after chemoradiation therapy, but 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 (32-38). 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 studies of Chang et al. (37), Chou et al. (39) Singh et al. (16), and Schwarz et al. (30), 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.

We believe our experience in patients with cervical cancer is generalizable to other gynecologic malignancies, and indeed to essentially all cancers. We have shown, in small studies, that FDG-PET has excellent sensitivity and specificity for assessment of vulvar and vaginal cancer, and there is substantial evidence supporting its utility in patients with ovarian cancer, especially for restaging or detection of suspected recurrent disease. PET is similarly useful in restaging and detection of suspected recurrent disease in patients with endometrial cancer. The National Comprehensive Cancer Network Practice Guidelines now endorse the use of PET at several points in the cancer care spectrum for patients with cervical cancer and ovarian cancer, as well as many other cancers.

We strongly support the expansion of PET coverage, as only covering an initial staging scan would not be practical or beneficial for cancer patients. FDG-PET is a valuable tool for radiation therapy treatment planning, and having patients undergo a PET scan in their particular treatment position is particularly beneficial. The post-therapy PETs that help evaluate response to treatment are also very useful for managing cancer patients and advancing cancer care. There should also be no roll-back in coverage for subsequent treatment evaluation uses of PET for currently covered cancers. We believe that physicians should have the flexibility to order PET scans as they find necessary and beneficial for their patients’ care, just as done with CT, MRI and other imaging studies.

Accordingly, we strongly recommend that CMS reconsider its proposed coverage policy and provide unrestricted coverage of FDG-PET for both initial treatment evaluation and subsequent treatment evaluation for all cancers

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

Perry W. Grigsby, M.D.
Professor of Radiation Oncology and Radiology

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

Siteman Cancer Center
Washington University School of Medicine

REFERENCES
1. Grigsby PW, Dehdashti F, Siegel BA. FDG-PET evaluation of carcinoma of the cervix. Clinical Positron Imaging. 1999;2(2):105-109.

2. Grigsby PW, Siegel BA, Dehdashti F. Lymph node staging by positron emission tomography in patients with carcinoma of the cervix. J Clin Oncol. Sep 1 2001;19(17):3745-3749.

3. Mutic S, Grigsby PW, Low DA, et al. PET-guided three-dimensional treatment planning of intracavitary gynecologic implants. International Journal of Radiation Oncology Biology Physics. 2002;52(4):1104-1110.

4. Miller TR, Grigsby PW. Measurement of tumor volume by PET to evaluate prognosis in patients with advanced cervical cancer treated by radiation therapy. Int J Radiat Oncol Biol Phys. Jun 1 2002;53(2):353-359.

5. Malyapa RS, Mutic S, Low DA, et al. Physiologic FDG-PET three-dimensional brachytherapy treatment planning for cervical cancer. Int J Radiat Oncol Biol Phys. Nov 15 2002;54(4):1140-1146.

6. Mutic S, Malyapa RS, Grigsby PW, et al. PET-guided IMRT for cervical carcinoma with positive para-aortic lymph nodes-a dose-escalation treatment planning study. Int J Radiat Oncol Biol Phys. Jan 1 2003;55(1):28-35.

7. Miller TR, Pinkus E, Dehdashti F, Grigsby PW. Improved prognostic value of 18F-FDG PET using a simple visual analysis of tumor characteristics in patients with cervical cancer. J Nucl Med. Feb 2003;44(2):192-197.

8. Grigsby PW, Siegel BA, Dehdashti F, Mutch DG. Posttherapy surveillance monitoring of cervical cancer by FDG-PET. Int J Radiat Oncol Biol Phys. Mar 15 2003;55(4):907-913.

9. Singh AK, Grigsby PW, Dehdashti F, Herzog TJ, Siegel BA. FDG-PET lymph node staging and survival of patients with FIGO stage IIIB cervical carcinoma. Int J Radiat Oncol Biol Phys. 2003;56:489-493.

10. Tran BN, Grigsby PW, Dehdashti F, Herzog TJ, Siegel BA. Occult supraclavicular lymph node metastasis identified by FDG-PET in patients with carcinoma of the uterine cervix. Gynecol Oncol. 2003/9 2003;90(3):572-576.

11. Esthappan J, Mutic S, Malyapa RS, et al. Treatment planning guidelines regarding the use of CT/PET-guided IMRT for cervical carcinoma with positive para-aortic lymph nodes. International Journal of Radiation Oncology Biology Physics. 2004;58(4):1289-1297.

12. 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(11):2167-2171.

13. Grigsby PW, Singh AK, Siegel BA, Dehdashti F, Rader J, Zoberi I. Lymph node control in cervical cancer. Int J Radiat Oncol Biol Phys. 2004;59(3):706-712.

14. Horowitz NS, Dehdashti F, Herzog TJ, et al. Prospective evaluation of FDG-PET for detecting pelvic and para-aortic lymph node metastasis in uterine corpus cancer. Gynecol Oncol. Dec 2004;95(3):546-551.

15. Grigsby PW, Mutch DG, Rader J, et al. Lack of benefit of concurrent chemotherapy in patients with cervical cancer and negative lymph nodes by FDG-PET. Int J Radiat Oncol Biol Phys. 2005;61(2):444-449.

16. Singh AK, Grigsby PW, Rader JS, Mutch DG, Powell M. Cervix carcinoma, concurrent chemotherapy, and salvage of isolated paraaortic lymph node recurrence. International Journal of Radiation Oncology Biology Physics. 2005;61(2):450-455.

17. Lamoreaux WT, Grigsby PW, Dehdashti F, et al. FDG-PET evaluation of vaginal carcinoma. Int J Radiat Oncol Biol Phys. 2005;62(3):733-737.

18. Lin LL, Mutic S, Malyapa RS, et al. Sequential FDG-PET brachytherapy treatment planning in carcinoma of the cervix. International Journal of Radiation Oncology Biology Physics. Dec 1 2005;63(5):1494-1501.

19. Wright JD, Dehdashti F, Herzog TJ, et al. Preoperative lymph node staging of early-stage cervical carcinoma by [18F]-fluoro-2-deoxy-D-glucose-positron emission tomography. Cancer. Dec 1 2005;104(11):2484-2491.

20. Grigsby PW. 4th International Cervical Cancer Conference: Update on PET and cervical cancer. Gynecol Oncol. 2005;99:S173-S175.

21. Belhocine T, Grigsby PW. FDG PET and PET-CT in uterine cancers. (Review). Cancer Therapy. 2005;3:201-218.

22. Hope AJ, Saha P, Grigsby PW. FDG-PET in carcinoma of the uterine cervix with endometrial extension. Cancer. Jan 1 2006;106(1):196-200.

23. Carey BP, Coleman RE, Grigsby PW, Siegel BA. Medicare coverage of PET for cervical cancer. J Am Coll Radiol. Jan 2006;3(1):19-22.

24. Xue F, Lin LL, Dehdashti F, Miller TR, Siegel BA, Grigsby PW. F-18 fluorodeoxyglucose uptake in primary cervical cancer as an indicator of prognosis after radiation therapy. Gynecol Oncol. Apr 2006;101(1):147-151.

25. Lin LL, Yang Z, Mutic S, Miller TR, Grigsby PW. FDG-PET imaging for the assessment of physiologic volume response during radiotherapy in cervix cancer. Int J Radiat Oncol Biol Phys. May 1 2006;65(1):177-181.

26. Lin LL, Mutic S, Low DA, et al. Adaptive brachytherapy treatment planning for cervical cancer using FDG-PET. Int J Radiat Oncol Biol Phys. Jan 1 2007;67(1):91-96.

27. Grigsby PW. The role of FDG-PET/CT imaging after radiation therapy. Gynecol Oncol. 2007;107(1, Supplement 1):S27-S29.

28. Grigsby PW. The contribution of new imaging techniques in staging cervical cancer. Gynecol Oncol. 2007;107(1, Supplement 1):S10-S12.

29. Kidd EA, Siegel BA, Dehdashti F, Grigsby PW. The standardized uptake value for F-18 fluorodeoxyglucose is a sensitive predictive biomarker for cervical cancer treatment response and survival. Cancer. Oct 15 2007;110(8):1738-1744.

30. Schwarz JK, Siegel BA, Dehdashti F, Grigsby PW. Association of posttherapy positron emission tomography with tumor response and survival in cervical carcinoma. JAMA. Nov 21 2007;298(19):2289-2295.

31. El Naqa I, Yang D, Apte A, et al. Concurrent multimodality image segmentation by active contours for radiotherapy treatment planning. Med Phys. Dec 2007;34(12):4738-4749.

32. 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. Gynecologic Oncology. 2003;90(1):186-190.

33. 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. Oct 1 2003;21(19):3651-3658.

34. 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(1):212-216.

35. 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(2):180-184.

36. 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. Feb 1 2004;100(3):544-552.

37. 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(1):164-171.

38. 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.

39. 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(2):442-448.

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TEMPLATE MESSAGE

To Whom it May Concern:
On January 6, the Centers for Medicare and Medicaid Services (CMS) announced its proposed National Coverage Determination (NCD) for oncologic PET, in response to the request from the National Oncologic PET Registry (NOPR) that CMS reconsider the current National Coverage decision on FDG-PET and to end the data collection requirements for diagnosis, staging and restaging for all cancers.

In brief, CMS is proposing to provide coverage for the initial treatment evaluation (current diagnosis and initial staging) for all cancers, except for prostate cancer and the already explicitly noncovered uses (breast cancer diagnosis and axillary nodal staging, and melanoma regional nodal staging). This coverage will provide for one PET scan per patient per cancer diagnosis. CMS also will cover subsequent treatment evaluation (including what is now considered treatment planning and restaging) for the big 6 (NSCLC, colorectal cancer, esophageal cancer, H & N cancer, lymphoma, and melanoma), as well as continuing coverage for breast cancer and adding this coverage for cervical cancer. For all other cancers, PET for subsequent treatment evaluation will require use under coverage with evidence development (CED). We do appreciate the willingness of CMS to expand coverage; however, I believe that this still falls short of what should be done to provide the best care foir cancer patients.

As an example, we have erecently studied a large number of patients with soft tissue and bone sarcomas.We evaluated in 42 patients whether FDG PET/CT after completion of neoadjuvant chemo-radiation therapy identifies histopathological treatment responders Relative changes in tumor FDG uptake and size from the baseline to the follow-up scan were calculated, and their accuracy for assessment of histopathologic response was compared by receiver operating characteristic (ROC) curve analysis. Histopathologic response was defined as ¡Ý95% tumor necrosis in excised tumor tissue. In histopathologic responders (n=8;19%), reduction in tumor FDG-uptake was significantly greater than in non-responders (p< 0.001), whereas no significant differences were found for tumor size (p=0.24). The area under the ROC curve for metabolic changes was 0.93, but only 0.60 for size changes (p=0.004). Using a 60% decrease in tumor FDG uptake as a threshold resulted in a sensitivity of 100% and a specificity of 71% for assessment of histopathologic response, whereas RECIST demonstrated a sensitivity of 25% and a specificity of 100%. Thus, quantitative FDG-PET was significantly more accurate than size based criteria at assessing histopathologic response to neoadjuvant therapy. FDG-PET should be the preferred modality to monitor treatment response in patients with high grade STS. It is evident from these data that following neoadjuvant treatment with CT imaging is not useful.We subsequently evaluated in patients with soft tissue sarcoma (STS) whether FDG PET/CT after completion of the first cycle of neoadjuvant chemotherapy identifies histopathological treatment responders. In histopathologic responders (n=8, 20%), reduction of tumor FDG uptake after one cycle of chemotherapy was significantly greater (-52%) than in non-responders (-20%; p=0.006). By comparison, the reduction of early tumor CT size in responders (-3%) was not significantly different from that in non-responders (+2%; p=0.15). All histopathologic responders and 13 (32%) non-responders had a ¡Ý30% reduction in SUV between the baseline and early scan while 19 non-responders (48%) had a decrease in SUV of < 30%. Using a ¡Ý30% reduction in FDG uptake as the threshold value for a metabolic response discriminated between histopathologic responders and non-responders with a sensitivity of 100% and a specificity of 59% (p=0.004). By comparison, no patient achieved even a partial response according to RECIST and CT had no predictive value at assessing early response (area under the receiver operating characteristic curve for size changes =0.69). Thus, FDG-PET provided an accurate, non-invasive modality to identify histopathologic response after only one cycle of neoadjuvant therapy in high-grade STS while CT had no predictive value at assessing early response to therapy. These findings has sevreal important implications. one is that ineffective treatments could be dicontinued as early as after a single cycle of chemotherapy in patients with sarcoma.

the first study has been published in Clinical Cancer Research in 2008 and the other one is in press in the same journal.

Similar findings were obtained in patients with bone tissue sarcomas. While one could argue that the number of patients enrolled in these studies in not very large I would submit that there are only around 10000 new sarcoma cases/year and that therefore these studies provide a sizable and representative patient sample.

As a second example, limiting the use of PET to a single pretreatment scan would preclude its involvement in radiation planning. Therefore, this limitation should be removed as it disqualifies all patients who undergo multiple treatments.

I also petition CMS to consider orphan cancers for broad coverage for PET/CT imaging. While acknowleding FDG-PET limitations in some cnacers there is overwhelming evidence in the literature that PET imaging can be used for monitoring of treatment effects in patients with rare cancers.

In addition, there should not be a roll-back in coverage for subsequent treatment evaluation uses of PET for the currently covered cancers.

Finally, there should be no gap in coverage for subsequent treatment evaluation for cancers that are now covered under NOPR and will continue to be covered only via CED until a successor CED program can be implemented.

FDG-PET/CT imaging is the most accurate modality to assess treatment responses in most cancers. No test is perfect but PET has been shown to be superior to all other imaging modalities in most cancers. It is therefore difficult for me to understand the rationale for limiting its use as proposed by CMS.

I would be happy to answer any of your questions regarding this letter.

Sincerely,
Johannes Czernin, MD
Porfessor of moleuclar and Medical Pharmacology
Director of Nuclear Medicine
Member: Johnson Comprehensive Cancer Center at UCLA

I am thus hoping I can implore you to take the time to compose a thoughtful comment about how PET helps you manage your patients (with both covered and currently non-covered cancers) more effectively. I was thinking you might be willing to submit a comment on your use of PET in patients with [cancer type(s)]. [Expand message to include institutional specific information-e.g., 'your comment should mention the results we previously have published', etc..] Ultimately, the key message to emphasize to CMS is that FDG-PET is an established cancer imaging method and it should be available for treating physicians to use as they deem necessary for management of their patients with all types of cancer. FDG-PET does not perform uniformly in every type of cancer, but neither do CT and MRI-it no longer makes sense for CMS to micromanage physician use of this important cancer diagnostic tool.

Please let me know if you have any questions. I will be happy to review your proposed comment before you upload to the CMS Web Site. Please include your full academic titles and make sure to mention [Cancer Center name] in your comment.

Thanks, in advance for your help.

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As a medical oncologist, Pet is the most useful diagnostic modality and should be readily available for all solid tumors and multiple myeloma. The CED restrictions for follow-up do not make any sense. THe PET often shows that patients are or are not responding to therapy and often do not correlate with CT or the CT scan cannot determine. Some patients may continue on therapy because their disease is only evaluable by PET, and they are actually not responding. OThers can appear progressive on CT but may be responding. NOPR documented these changes in therapy and they are clinically apparent as well.

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I am a myeloma specialist and have been treting myeloma patients for the last 16 years. I see more than 200 new myeloma patients each year. Our goal is to cure this disease. Our extensive experience on > 10,000 myeloma patients has told us that the two most important prognostic markers are genetic information as obtained by cytogenetics and gene expression profiling, and extend of disease as assesssed by MRI and PET/CT scan. Skeletal surveys as typically recommended for myeloma are outdated and do not allow us to evaluate how effective our treatments are. MRI and PET/CT scan both have strnghts and weaknesses. The major strength of the PET/CT scan is that it tells us very early on if treatment is effective. It is also very good in detecting early relapse, sometimes way before myeloma markers become abnormal. Early detection of relapse is critical for a good outcome with salvage therapy. Finally,The PET/CT scan will detect extramedullary myeloma, while MRI or skeletal surveys will not. Extra-medullary myeloma is associated with a poor prognosis and requires a more intensive and timely treatment. It would be a major disfavor to our patiets by denying follow-up PET/CT scans for restaging to monitor response and detect early relapse,and in case of a single area relapse to provide local radiotherapy.

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On behalf of Alliance Imaging, the largest provider of PET services in the nation, we appreciate the opportunity to comment on CMS’s proposed decision memorandum regarding the expansion of PET coverage for purposes of initial and subsequent treatment strategies for certain designated solid tumors. While we believe the approach outlined in the proposed decision memorandum is a step in the right direction, in our view it does not go far enough. As stated in our comments submitted on October 13, 2008, we strongly encourage CMS to establish a coverage framework which ultimately relies on the professional judgment of treating physicians to determine the appropriate use of PET without imposing unnecessary burdens or preconditions on such physicians’ ability to obtain Medicare coverage for their patients.

Assuming CMS proceeds with its proposed coverage framework, however, we believe the evidence does support the broad expansion of coverage for PET imaging to all solid tumors when determining initial treatment strategy.

Furthermore, we would urge CMS to consider expansion of coverage for PET for subsequent treatment strategy without the need for coverage with evidence development (CED) specifically with respect to ovarian and uterine cancers. In this regard, we offer the following clinical evidence. Iaguru et al. from Stanford University, based on a retrospective review of 43 women with ovarian cancer as reported in Nuclear Communications in 2008, found that “The main advantages of PET/CT for ovarian cancer are in restaging, finding extra-pelvic lesions that can affect patient management, and in evaluation of those patients with increased CA-125 levels.” They concluded that “…the good results of 18FDG PET/CT for identification of residual/recurrent ovarian cancer, as well as for distant metastases localization. PET/CT should be an integral part in evaluation of patients with high-risk ovarian cancer or rising values of tumor markers (CA-125), prior to selection of the most appropriate therapy.”

In addition, Mangili et al. reported in 2007 that a change in clinical management was observed in 44% of cases when PET/CT information was added to conventional follow-up findings. Kitajami et al. found that integrated PET/contrast-enhanced CT is a more accurate imaging modality than PET/non-contrast-enhanced CT and enhanced CT for assessing recurrence of ovarian cancer, and led to changes in the subsequent clinical management of 39% of 132 patients with recurrent ovarian cancer.

Similarly, Kitajima et al. found that FDG-PET/contrast-enhanced CT is a more accurate modality for assessing recurrence of uterine cancer, and led to more appropriate subsequent clinical management than that resulting from PET alone or enhanced CT selection of the optimal therapy, leading to changes in the subsequent clinical management in 42% of 90 patients.

As a result of these findings, we encourage CMS to include ovarian and uterine cancers on the list of covered diseases that do not require CED for use in connection with subsequent treatment strategy.

We also believe that the evidence supports the removal of breast cancer from the list of exceptions to coverage for initial treatment strategy. We note that in its proposed decision memorandum, CMS indicates that it did not review new evidence on the use of FDG PET imaging to determine initial anti-tumor treatment in breast and therefore “…will continue to cover FDG PET imaging for the initial treatment strategy for male and female breast cancer only when used in staging distant metastasis. FDG PET imaging for diagnosis and initial staging of axillary nodes will remain noncovered.”

We offer the following clinical evidence in support of the position that breast cancer should be removed from the list of exceptions to coverage for initial treatment strategy. In 2007, Veronesi published in the Annals of Oncology “A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary Metastases.” 236 patients with breast cancer with clinically negative axilla were studied. The author’s conclusion was that “The high specificity of PET imaging indicates that patients who have a PET-positive axilla should have an ALND rather than an SNB for axillary staging. In contrast, FDG-PET showed poor sensitivity in the detection of axillary metastases, confirming the need for SNB in cases where PET is negative in the axilla.” This finding was confirmed in a 2009 paper by Taira et al. published in the Jpn J Clinical Oncology, indicating that patients with positive PET are candidates for ALND and not SNB. Furthermore, Fuster et al. feel that due to the high specificity of PET positive findings on PET should guide intervention along the lines of ALNB rather than SNB, noting that the use of PET led to a change in initial staging of the disease in more than 40% of patients.

As a result of these findings, we feel that the use of PET for initial staging of axillary nodes in breast cancer should be covered.

In closing, we would again call your attention to the National Oncologic PET Registry’s March 2008 published results which clearly demonstrate that PET is an essential component of cancer diagnosis and care. The published results showed clinicians changed their intended course of care for more than one in three cancer patients as the result of PET scan findings. The expansion of reimbursement coverage for PET would therefore have a direct and positive impact on the 1.4 million Americans projected to be diagnosed with cancer this year.

Sincerely yours,

Mark P. Carol, M.D.
Chief Medical Officer
Alliance Imaging

Bibliography:

Veronesi U, De Cicco C, Galimberti VE, Fernandez JR, Rotmensz N, Viale G. A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary metastases. Annals of Oncology 18: 473–478, 2007

Taira N, Ohsumi S, Takabatake D, Hara F, Takashima S. Determination of Indication for Sentinel Lymph Node Biopsy in Clinical Node-negative Breast Cancer Using Preoperative 18 F-fluorodeoxyglucose Positron Emission Tomography/ Computed Tomography Fusion Imaging. Jpn J Clin Oncol 2009;39(1)16 – 21

Fuster D, Duch D, Paredes P, Velasco M, Munoz M, st al. Preoperative Staging of Large Primary Breast Cancer With 18Fluorodeoxyglucose Positron Emission Tomography/ Computed Tomography Compared With Conventional Imaging ProceduresJ Clin Oncol 2008, 26:4746-4751

Iagaru AH, Mittra ES, McDoygall IR, Quob A, Gambhir SS et al. 18F-FDG PET/CT evaluation of patients with ovarian carcinoma. Nuclear Medicine Communications 2008, 29:1046–1051

Mangili G, Picchio M, Sironi S, Vigano` R, Rabaiotti E, Bornaghi D, et al. Integrated PET/CT as a first-line re-staging modality in patients with suspected recurrence of ovarian cancer. Eur J Nucl Med Mol Imaging 2007; 34:658–666.

Kitajima K, Murakami K, Yamasaki E, Domeki Y, Kaji Y, et al. Performance of integrated FDG–PET/contrast-enhanced CT in the diagnosis of recurrent ovarian cancer: comparison with integrated FDG–PET/non-contrast-enhanced CT and enhanced CT . Eur J Nucl Med Mol Imaging (2008) 35:1439–1448

Kitajima K, Murakami K, Yamasaki E, Domeki Y, Kaji Y, et al. Performance of integrated FDG-PET/contrast-enhanced CT in the diagnosis of recurrent uterine cancer: comparison with PET and enhanced CT Eur J Nucl Med Mol Imaging (ahead of print)

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PUBLIC COMMENT

I understand that CMS is proposing to provide coverage for the initial treatment evaluation (currently called diagnosis and initial staging) for all cancers, except for prostate cancer and those indications that are already explicitly non-covered (breast cancer diagnosis and axillary nodal staging, and melanoma regional nodal staging). CMS also will cover subsequent treatment evaluation (including what is now considered treatment planning and restaging) for non-small cell carcinoma, colorectal cancer, esophageal cancer, head and neck cancer, lymphoma, and melanoma, as well as continuing coverage for breast cancer and adding this coverage for cervical cancer. This includes many of the patients we care for with gastrointestinal malignancies.

1. I strongly support that the current framework for coverage of FDG PET should be modified, at a minimum, as proposed in the National Coverage Decision dated January 6, 2009. I believe the evidence supports the broad expansion of coverage of FDG PET to all solid tumors when determining initial treatment strategy. Even though the published evidence may be limited for some cancers to small series of patients, our extensive personnel experience confirms the published data, especially regarding patients with pancreatic and hepatobiliary malignancies.

2. I am grateful that patients will have coverage for subsequent treatment strategy evaluations for non-small cell carcinoma, colorectal cancer, esophageal cancer, head and neck cancer, lymphoma, melanoma, breast cancer, cervical cancer and thyroid cancer, and would definitively not want to see any changes in the proposed coverage for these cancers. FDG PET/CT is extremely helpful to us in making management decisions for in these patients with proven cancer undergoing therapy or to assess for residual or recurrent disease after completion of therapy.

3. I urge that coverage for subsequent treatment strategy evaluations should soon be added for all solid tumors. Additionally, there should be no gap in coverage for subsequent treatment evaluations for cancers that are now covered under NOPR (National Oncologic PET Registry) and will continue to be covered only via a successor Coverage with Evidence Development (CED) program. A mechanism for continuing current coverage until a successor CED program can be implemented is essential.

4. Finally, I wish to emphasize from our perspective as practicing oncologists the fundamental principle that FDG-PET is a well-established cancer imaging method and it should be available for use by treating physicians as they deem necessary for management of their patients with all types of cancer. I acknowledge that FDG-PET does not perform uniformly in every type of cancer, but neither do CT or MRI—it no longer makes sense for CMS to micromanage physician use of this important cancer diagnostic tool.

J. Kelly Wright, Jr., MD, FACS Professor of Surgery, Vanderbilt University School of Medicine]Chief, Division of Hepatobiliary Surgery and Liver Transplantation Nashville, TN

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I feel strongly about these key points: PET led to a change in the initial treatment approach in over one-third of all cases in which it was employed.

Recognize the limitations of the NOPR data in linking the use of PET to patients'' long-term clinical outcomes

Consider supporting CMS'' proposed decision to lift the CED requirements to allow Medicare coverage of one PET scan to guide the "initial treatment strategy" for cancer patients with a confirmed or strongly suspected diagnosis of solid-tumor cancer.

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CMS Approvals for PET in Breast Cancer

To whom it may concern:

I am a Professor of Medicine at the University of Arizona, specializing in the treatment of breast cancer. I am the former Chair of the Breast Committee of the Southwest Oncology Group, and remain a member of its Working Group.

From my perspective as a medical oncologist, the greatest single use for FDG-PET at present is in the serial evaluation of response. The best example may be in the situation of bone lesions, which are often well imaged on PET. When this is the case, it is by far the best modality of radiologic imaging to determine the effect of therapy, depending as it does on tumor metabolism rather than host response. In addition, PET is indicated in the staging of breast cancer when there are large or medially placed lesions suggesting the possibility of internal mammary or supraclavicular nodal involvement, areas which are not surgically staged, and may be poorly imaged by other available modalities. It is important to make sure that the new CMS indications preserve these usages for this important modality.

Sincerely,

Robert B Livingston, MD

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I would strongly encourage the continued use of PET/CT data for evaluation of treatment effects, especially in the setting of rare tumors and recurrent or refractory disease, where it will be much harder to have all uses of PET confined within a prospective trial design. Our institution treats about 10% of the US patients with relapsed osteosarcoma, but that still amounts to fewer than 150 patients each year. Treatment must be individualized to obtain best results. By using PET data I have been able to provide targeted radiotherapy to selected sites of disease that were not responding to an otherwise effective therapy, long before RECIST criteria would have identified these progressions. The result is that patients are living longer. We presented our data at last year''s ASCO meeting: http://meeting.ascopubs.org/cgi/content/abstract/26/15_suppl/10036?maxtoshow=&HITS=&hits=&RESULTFORMAT=1&author1=hughes%2C+d&title=osteosarcoma&andorexacttitle=and&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT

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PET/CT imaging has CHANGED the practice of oncology. In Hodgkins Dz and NHL we scan after 1 or 2 doses and know whether we will get a remission/cure. If still + then we consider high dose therapy without wasting $ on chemo cycles that will not be curative!

The PET/CT is invaluable in melanoma since many sites will not be seen on CT/MRI. PET/CT changes management of NSCLC, upstaging patients at diagnosis - saving $$ for unnecessary surgery =/or RoRx. It is much more sensitive for restaging.

Areas that appear to be active tumor/ metastasic lymph nodes can be shown to be PET negative and simply observed, saving $ for biopsy or therapy. This is one test that is cost effective.

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As a technical coordinator and registered PET technologist, I personally witness every day how PET results in a much higher degree of accuracy than is achieved by anatomic imaging alone. PET has and continues to have a profound impact on patient care. Yet, the regulatory requirements for a study to be performed are set at a higher standard than for anatomic imaging techniques. Please, allow PET to be used in the same manner and with the same ease as is currently allowed for other modalities such as CT and MRI. PET has been shown to be useful in our practice for cancer patients, and this usefulness is also well documented in medical literature. Patients are so convinced of it''''s usefulness that they often pay out of pocket for PET. Please change CMS policy to reflect the usefulness of PET techniques in the health and well being of our U.S. population.

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The decision as to what tests and treatments for a disease such as cancer should be left to the professionals - meaning the doctors. Maybe you need to fine-tune this policy. There is a difference between Non-invasive and Invasive cancer. If you don''t know the difference, you should educated yourselves on this topic. Preliminary scans and biopsies can usually determine which. ANYONE WITH AN INVASIVE CANCER SHOULD HAVE WHATEVER TESTS THE DOCTOR/S DECIDE IS USEFUL FOR PROPER DIAGNOSIS. PERIOD. WITH CANCER, THE MORE INFORMATION YOU HAVE, THE BETTER. Besides the degree of disease, a financial ability to pay test can be used. Just because someone is too poor for a test does not mean they should not have decent medical care. Isn''t that what you are supposed to be supplying?

As a taxpayer and a human being, all I can say is I am appalled by the wrongheaded, even stupid, methodology applied in this case. It is the same non-logic used by insurance companies.

Let''s see if I have this right. You think it will save a few bucks if you cheap out and not do the expensive test. How much do 2 or 3 CTs cost as opposed to one PET scan? Many cancers are now survivable, if caught in time. Meanwhile, in the time it takes for multiple tests to be done to find out how far the cancer has spread, the cancer spreads further, making treatment more difficult. This is crucial if the patient has an aggressive cancer. Time is not your friend.

Maybe the plan is they will just die and be done with it.

So, my question to you is: If this was you, or your child, your parent, or your grandparent, who would you want to decide which tests and treatments are to be used?

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CMS should do all they can to expand PET coverage. There may be a small percentage of false positives but when you have a PET scan you see all the cancer all through the body not just one area like other modalities. I am a nuclear medicine professional and have performed PET scans and know it is a very reliable test. If I were diagnosised with cancer I would want a PET scan so I could know how spread the disease is. Think of it as yourself or a family member wouldn''t you want the best there was to offer in cancer diagnosis.

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