Positron Emission Tomography (FDG) for Solid Tumors

I think CMS is correct in proposing to end the prospective data collection requirements under Coverage with Evidence Development (CED) for all oncologic indications for FDG-PET imaging. I am encouraged by your decision to cover one FDG-PET scan for subsequent treatment strategy indications for all cancers (except for prostate cancer), based on data available to date.

However, I am concerned about the lack of defined coverage for subsequent PET imaging beyond that one subsequent treatment study, as such additional study coverage has been left to the discretion of the local Medicare Administrative Contractor. By not defining additional coverage strategies beyond one subsequent treatment study, CMS has created a system whereby the local MAC is empowered to arbitrarily decide who may or may not benefit from additional testing. Based on factual evidence and experience to date, I feel that the physicians directing a patient’s care are in the best position to answer that question. Therefore, I request that CMS reconsider its policy as it pertains to subsequent treatment FDG-PET imaging to recognize that need.

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I am writing to voice my concern over the proposal to limit PET CT scans to 1 subsequent treatment study.

Based on personal experience I can tell you that the use of PET scans are very important in the treatment decisions and well being of people with cancer. For patients with ongoing treatment of cancer that has spread, PET scans help pinpoint the needed areas for treatment. That alone should be enough of a reason to not limit them, however there are mare reasons.

If you compare pet scans taken over a period of time, they are very informative when matched up with treatment courses. For a patient, just being able to see that treatment is working; not wondering or guessing, is a huge help in keeping a positive outlook and ultimately staying alive. Pet scans are also beneficial to pick up areas needing to be focused on for future treatment.

Confirmation that you actually know your body is important. You remember where the pain was. Reviewing current and prior scans with your doctor allows you to match what you are seeing with what you are feeling or have felt. This important correlation gives you, the patient, power of knowledge. It provides you with the confidence to help your treating physicians by pointing out new areas to treat. In short, it helps you help them,(the doctors) as they help you.....I hope that made sense..

Limiting pet scans would be a HUGE negative hit to the treatment and outcomes for patients afflicted with this disease. Treatment and outcome are significantly affected by both the physical and psychological parts of treating and managing this disease. Please do not take this away. I can only hope that i have been able to convey in a small way the need to allow physicians and patients to decide what is best for their own treatment. This disease has as many nuances to it as there are patients with it.

Taking away a tool like this, one that assists in the care and quality of one’s life, would be a truly sad day.

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I am the section chief for nuclear medicine at the University of New Mexico Hospital, which serves as the primary PET imaging site for the University of New Mexico Cancer Center (an NCI-designated cancer center). In this role, I protocol and interpret many of the PET scans ordered by my clinical colleagues. Although many patients receive only one to two PET scans for a particular malignancy, others receive additional scans, particularly in the setting of known or suspected recurrent disease.

I have read with concern the CMS proposal to limit coverage for follow up PET imaging for subsequent treatment strategy to one PET scan. I am writing in strong support of the joint comments submitted by the World Molecular Imaging Society in conjunction with multiple other imaging specialty societies.

Perhaps the most surprising and concerning aspect of this decision is what appears to be a revocation of coverage for multiple cancers that were previously covered. Although the decision language initial states that this decision applies to the tumors previously covered under CED (coverage with evidence development), the final language appears instead to apply to all cancers.

We treat and image patients, often with advanced staged of illness, who may travel from great distances (we serve most of New Mexico plus some portions of adjacent states). Our patients include underserved rural and minority (primarily Native American and Hispanic) populations. One specific type of cancer we see frequently (among many), in which PET imaging is critical, is head and neck cancer. These patients require a PET scan for initial planning and at the end of therapy to ensure therapeutic efficacy versus need for additional treatment. Unfortunately, these patients may return with clinically suspected or biopsy-proven disease recurrence, and require PET imaging in a timely fashion to allow appropriate restaging and therapeutic planning. Requiring the use of local MACs to approve subsequent scans may very well delay or deny appropriate care to these patients, or require their treating physicians to substitute costly but less sensitive/specific staging techniques (e.g., CT, MRI).

Other cancers frequently seen at our institution, in which PET scanning is clearly appropriate for suspected disease recurrence, and for which conventional imaging may be less sensitive, include lymphoma and lung cancer.

I urge you, at a minimum, to reconsider the revocation of coverage already approved and provided by Medicare for subsequent treatment strategy for multiple cancers, and consider expanding this coverage to all cancers.

Sincerely,

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. In general, I would like to express my strong agreement with the comments submitted by others, specifically the Joint-Society letter from the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). I would also would like to express my vigorous support for the comments and data submitted by the National Oncologic PET Registry (NOPR) Working Group.

I applaud CMS’ proposal to end Coverage with Evidence Development (CED) data collection for the use of FDG-PET for oncologic indications. I strongly agree with the original requestors that sufficient evidence has accrued regarding the substantial benefit in management of patients afflicted by cancer to lift the previous CED requirements.

However, I am surprised and dismayed by several of the components of the recent proposed decision memorandum.

I would like to voice my strongest possible opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. I am shocked that CMS proposes the extraordinary step of reversing coverage for post-treatment evaluations that has been in place for the majority of Medicare’s cancer patients for years. This proposal represents an inestimable setback in the ability to optimize treatment for millions of cancer patients. We strongly urge that CMS reconsider this portion of its proposal, and remove this restriction from its final decision on the initial request. Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. For many patients, it is the single most important diagnostic modality in managing their treatment. To remove this critical tool from the cancer specialists' armamentarium would have an adverse effect on the care of millions of Medicare beneficiaries. While it is true that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, there a number of better mechanisms to address over-utilization without such draconian measures and without grave consequences for patients who legitimately require FDG-PET imaging for their care.

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully submitted,

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Comment to CMS Regarding Coverage of FDG-PET Scans

On Behalf of The University of Texas MD Anderson Cancer Center

In the proposed Decision Memo for Positron Emission Tomography (FDG) for solid tumors (CAG-00181R4), CMS determined that a single FDG-PET study would be covered in the subsequent anti-tumor treatment strategy setting, and that coverage of any further scans to guide therapy would be determined by the local Medicare Administrative Contractors. We are grateful for the expansion of coverage for indications previously reimbursed through Coverage with Evidence Development (CED). However, we feel that this restriction to a single follow up scan will act as a barrier to the appropriate utilization of PET/CT by our physicians in the care of their patients. This is particularly true with regards to the cancers NOT previously subject to CED.

MD Anderson Cancer Center is an NCI-designated comprehensive cancer center. On a daily basis, we provide care to patients with a variety of cancers at all phases of their disease. Our multidisciplinary teams need access to a broad array of diagnostic and therapeutic procedures to optimize and personalize this care. FDG-PET/CT is an extremely valuable tool in the evaluation and management of many patients with cancer, and its value extends beyond the initial evaluation and immediate post-therapy follow up period. Frequently, patients come to MD Anderson Cancer Center with recurrent or refractory disease, and in these cases FDG-PET/CT can provide diagnostic and prognostic data which can directly influence therapy decisions.

The usefulness of PET has been demonstrated by the results of the National Oncologic PET Registry, in which we were an active participant. Our physicians are at the forefront of cancer research and treatment, and participate in national and international efforts to establish guidelines and recommendations for the workup and management of the cancer patient. In some cases, these guidelines recommend the use of FDG-PET/CT in the follow up period to detect recurrence, guide treatment, and monitor therapeutic response, potentially beyond the immediate post-treatment setting when justified by clinical findings.

We are in strong support of the posted comment by Rohren, Swanston, and Macapinlac on behalf of the Section of PET/CT at MD Anderson. The bibliography of MDACC-authored publications supplied in their comment support the assertion that FDG-PET/CT can provide valuable clinical information beyond the first follow up scan.

We urge CMS to reevaluate this proposed Decision Memo CAG-00181R4, and remove the language restricting patients to a single FDG-PET in the subsequent treatment strategy setting. We believe, based on the results of the National Oncologic PET Registry and the current literature, that CMS should provide coverage for FDG-PET/CT in all solid tumors (perhaps with limited exceptions), both in the initial evaluation period and in follow-up, without restriction on number or frequency of scans provided the study is medically indicated.

Sincerely,

Ronald A. DePinho, M.D.
President
Professor, Department of Cancer Biology
The University of Texas MD Anderson Cancer Center

Waun Ki Hong, M.D.
Vice Provost for Clinical Research
Division Head, Cancer Medicine
Professor, Department of Thoracic and Head & Neck Medical Oncology
The University of Texas MD Anderson Cancer Center

Thomas A. Buchholz, M.D.
Provost and Executive Vice President ad-interim
Division Head, Radiation Oncology
Professor, Department of Radiation Oncology
Frank T. McGraw Memorial Chair in the Study of Cancer
The University of Texas MD Anderson Cancer Center

Robert C. Bast Jr., M.D.
Vice President for Translational Research
Professor of Medicine, Department of Experimental Therapeutics
Harry Carothers Wiess Distinguished University Chair for Cancer Research
The University of Texas MD Anderson Cancer Center

Stephen G. Swisher, M.D.
Division Head ad interim, Surgery
Professor, Department of Thoracic and Cardiovascular Surgery
Robert F. Fly Professorship of Surgical Oncology
The University of Texas MD Anderson Cancer Center

Marshall E. Hicks, M.D.
Division Head, Diagnostic Imaging
Professor, Department of Diagnostic Radiology
Levit Family Distinguished Chair in Diagnostic Imaging
The University of Texas MD Anderson Cancer Center

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As a medical oncologist, I believe that limiting PET scans for our patients without considering each individual's situation is detrimental to patient csre. Cancer many times does not present in a textbook fashion nor can it be approached in a textbook manner. A patient who has NSCLC with limited metastases which are resected will undergo surveillance scans. Such a patient is not only at risk for recurrence of disease but also second primary cancers. How do we appropriately manage patients whose cancers recur or go on to develop other cancers? For my patients with head and neck cancers and esophagogastric cancers, I often depend on PET/CT to help assess treatment response and tumor recurrence. It is particularly useful in assessing lymph node status. For patients in whom a CT is insufficient to assess response, a PET scan is often helpful to avoid additional procedures (eg biopsy).
It would be incredibly difficult to continue to take proper care of our patients without sufficient tools to assess the effectiveness of our treatments.

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Dear Committee,

I am a lymphoma specialist and Co-Director of Clinical Research for Lymphoma at MD Anderson Cancer Center. In our practice, PET is extremely valuable for staging both low and high grade lymphomas. In addition, PET is essential for confirming response in lymphomas that are routinely PET avid, and is part of our standard staging/response criteria for lymphoma (Cheson et al 2007). I hope that the committee continues to approve this valuable tool for initial staging of patients with lymphoma.

As a method of restaging and following patients in remission, PET is also essential in many circumstances. In patients with sites extra-nodal disease such as bone and soft tissue, CT is inadequate for imaging and will often result in a false negative finding. PET scan is preferred over CT scan to follow these patients and confirm relapse. In addition, PET is used in patients who only attain a partial remission following initial or salvage therapy. Patients with partial remission still have active disease, and PET is used in our group to document disease evolution, and occasional spontaneous remission (can occur in up to 30% of patients with indolent lymphoma). Finally, in patients who have a questionable CT finding, a PET scan is often valuable to help determine the CT lesion’s malignant potential. I personally have been able to avoid several unnecessary biopsies of indeterminate CT findings by using PET.

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Dear Dr. Jacques,

I am a Professor of Medicine at Washington University in St. Louis specializing in the treatment of lymphoma. I was shocked to hear of CMS’s decision to limit PET/CT scans to “one per patient” following their initial staging PET/CT scan. I have been involved in the design and conduct of multiple clinical trials for patients with Hodgkin and non-Hodgkin lymphoma to help determine the benefit of PET/CT scans as a prognostic factor and more importantly to guide treatment strategy. I agree that there is no proof of benefit for the use of PET/CT as a surveillance method in patients who are in complete remission at the completion of therapy. However, the use of PET scans during and immediately following therapy has become critical in making appropriate treatment decisions. If we are limited to one PET scan per patient during their therapy and subsequent course, the most difficult situation would be a patient who has a positive PET at the completion of treatment (this applies to both Hodgkin lymphoma and many subtypes of non-Hodgkin lymphoma). We know from several studies that this portends a much worse prognosis. The PET/CT response to the subsequent line of therapy has been shown to be highly prognostic in terms of their outcome and whether they should proceed with stem cell transplant. A CT scan would not provide the information needed in terms of whether the patient had achieved a complete remission and is ready to receive a stem cell transplant or whether they need additional salvage therapy. The inability to receive additional PET/CT scans without “jumping through multiple hoops” would be quite detrimental. My fear is that your decision would harm the care of those patients who already have the most tenuous prognosis (specifically those with positive interim or post-treatment scans) and where additional PET/CT scans are critical in making appropriate decisions for patient treatment. I am hopeful that you will reconsider this decision. While I am supportive of some limitation on the use of PET/CT, particularly in the setting of surveillance, there are multiple scenarios that would require more than one PET/CT during the patient’s treatment and subsequent relapses. Thank you very much for your consideration in this matter.

Sincerely,

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Myeloma was one of the cancers assessed under NOPR 2006: the first phase of NOPR. Following this first phase, on April 3, 2009, CMS expanded coverage to include myeloma with respect to treatment monitoring, restaging, and evaluation of suspected recurrent disease.

From the perspective of myeloma patients, I strongly support the proposal to remove the remaining prospective data collection requirements for FDG PET imaging for those oncologic indications where such scans continue to be covered under CED.

However, it is our understanding that CMS intends to impose a one-scan limitation to apply to subsequent patient management for ALL solid tumors including myeloma for which CED was removed and for which national coverage currently exists pursuant to CAG-00181R3.

Since national coverage already exists for myeloma, this should not be changed. It is strongly encouraged that CMS clarify the final decision memorandum to indicate that this policy only applies to tumors currently covered under CED in the NOPR 2009 and that myeloma, approved under NOPR 2006, will not be imposed with a one-scan limitation provision.

Any potential “one-scan limitation” is highly inappropriate for myeloma patients for whom the prevailing standard of care is similar to that for lymphoma patients and typically involves more than on subsequent treatment strategy scan for patient management. Any limitation would have the perverse effect of requiring alternate and more expensive imaging for disease assessment. Better novel therapies and longer survival have increased the dependence on FDG PET imaging to restage non-secretory or hyposecretory myeloma disease (which resembles lymphoma).

From an administrative standpoint, it is extremely harmful to consider a “one-scan limitation” for myeloma patients. By increasing the need for signature of ABN form, patients will end up receiving suboptimal and more expensive imaging which is truly counterproductive. From the opposite perspective, there is no evidence that FDG PET is used in an inappropriate surveillance fashion. Thus, although one can appreciate potential concern about overutilization, there is no evidence (for example, from NOPR 2006) that this occurred to any extent.

Proposed Alternate National Coverage Framework: In summary, myeloma patients are best served if CMS rejects the proposed “one-scan limitation” and instead retains (or institutes or reinstitutes) national coverage which can be subject to local MAC discretion. This approach balances medical necessity and any concern about potential surveillance use of FDG PET.

Respectfully submitted,

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First of all, I would like to thank CMS for broadening coverage for specific tumor types.

I understand that the PET/CT scans are not for use in the surveillance setting of cancer management, but it is indicated for monitoring response to therapy and to reassess disease status for recurrence.

I have found PET/ct scans to be extremely useful in managing cancer patients. The best, most recent example involves an unfortunate 38 year old woman I am treating for metastatic breast cancer. She had her first PET/CT scan at her initial diagnosis of advanced breast cancer due to the extensive involvement of axillary lymph nodes. Her second PET/Ct scan was done when she was initially diagnosed with metastatic disease. She had completed her first line of therapy with a good response based on tumor markers and the CT scans that her insurance would approve (they would not approve PET/CT scans). Within the next 4-5 weeks, the patient developed severe neck pain, and developed upper extremity paralysis due to cervical spine epidural metastasis recurrence that could have been diagnosed and treated if found earlier with a PET/CT scan. Several days of hospitalization and loss of function could have been avoided if the PET/CT scan were available and not denied by insurance. This is simply a recent example where appropriate use of the PET/CT scan can permit early detection of disease and prevent medical problems and complications due to cancer progression.

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Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques:

The Greenville Health System Cancer Institute is the largest cancer care provider in the Upstate of SC covering 10 counties and treating over 6500 new patients each year. On behalf of the cancer patients we represent, we are writing to express our strong opposition with the proposed limitation of coverage for the use of FDG-PET in the treatment strategy of cancer patients.

FDG-PET is very useful in managing the treatment of cancer patients. The use of FDG-PET is appropriate in the post-therapy setting to assess treatment efficacy or to evaluate suspected recurrence/progression. There are many situations where the use of more than one scan is clinically necessary. Without the ability to monitor the effectiveness of treatment, the patient could receive expensive and toxic therapies that could have been avoided. Physicians may also have to resort to increasing the use of invasive procedures to determine recurrence or progression. Neither of these options would benefit the patient and would ultimately increase the cost of providing cancer care.

Many cancer patients go through several variations of response in their cancer journey: response to treatment, progression, remission and then recurrence. Limiting the number of FDG-PET scans to ONE will adversely affect physicians from providing the most effective treatment to our patients. As a medical oncologist, my goal is to cure a patient of cancer. If the cancer cannot be cured, my goal is to ensure that my patients can live with as favorable a quality of life as possible, for as long as possible. Without the ability to ensure that the therapy is working or not or to see if there has been a recurrence or progression will hinder my ability to meet my goals.

We also oppose the proposal of a case-by-case approval process by the local Medicare Administrative Contractors (MAC) for additional scans. This would add an unnecessary burden on everyone: the MAC, the patient, the physician and the physician’s administrative team. The MAC would lean towards being skeptical in approving additional scans if one scan is the default. This would delay the timing of the scan and would lead to further expense and delays from multiple appeals. It will also put the burden on the patient of deciding to continue the treatment regimen recommended by their physician or potentially incur thousands of dollars of out of pocket costs.

Cancer treatment is hard on patients and their family members. Seriously ill patients would have to wonder if their treatment is working, if their scans will be covered, if they will have to come up with the money themselves, or if they will have to face a delay in treatment. Adding this additional burden to cancer patients is unnecessary and should be avoided.

The physicians of Greenville Health System Cancer Institute strongly suggest that CMS NOT finalize the proposed one-scan limit. We also strong suggest that CMS NOT require tumor-by-tumor or case-by case approval by the MAC for additional scans.

Thank you for the opportunity to comment and for your consideration to continue to improve the care provided for cancer patients.

Sincerely,

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April 12, 2013

Re: Comments from the Community Oncology Alliance on the Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Dear Dr. Jacques:

On behalf of the Community Oncology Alliance (COA), a non-profit organization representing the interests and well-being of community oncology practices and the patients they care for, I am submitting comments relating to the proposed Decision Memorandum for 18F-Fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors.

The COA cancer care delivery team is most appreciative of CMS’s broadening coverage for a wider variety of tumors, as this will accentuate not only the delivery of appropriate care, but also the most effective and cost efficient treatment for patients diagnosed with such tumors. And too, COA is in agreement with the proposal to end Coverage with Evidence Development (CED) data collection for use of FDG-PET for oncology indications, supported by the plethora of scientific literature and registry trials data with NOPR. Without question, physicians treating patients with solid tumors would be lost without this valuable modality of truly visualizing tumor status, post treatment. Further, the ability to expeditiously evaluate a possible recurrence and/or progression can actually alter the potential lifespan of a given patient.

COA physicians include FDG-PET as an indispensible instrument within their armament of diagnostic tools and, when used appropriately for the management and well-being of their unique patient base, can be the determining factor in how best to arrest tumor recurrence or progression. Limiting the number of scans to two (2) is akin to removing a key diagnostic tool from the hand of the physician charged with the management and well-being of that patient’s life. Treating cancer is not like changing the tires on a vehicle and being good to go. Prescriptive therapy changes frequently and always on an individual basis. There is no one-size- fits- all in cancer. That is why FDG-PET is included in the treatment arsenal and plan of care in any number of current cancer treatment guidelines.

COA is aware that the option to request an exception to the two scan maximum is out there, but frankly, the additional time and effort needed to achieve that consideration is almost impossible to carve out in an oncologist’s incredibly busy day. We sincerely doubt that you are aware of the number of denials or requests for medical necessity that are received in every oncology clinic in America, both community and hospital-based. Denials or reviews can be for various drugs, radiation, radiology, nuclear medicine, home care, rehabilitation and so much more. Our patient mix is as varied as the number of insurance companies who remit payment for those billable services rendered. And, in anticipation of 2014, with an expanded patient base of newly insured, those exception requests will likely expand exponentially. It will be humanly impossible to give due diligence to every single exception. The absence of that ability to appeal will equate to a death sentence for many.

As of today, we can confidently tell you that there are thousands of patients who are denied appropriately ordered diagnostic studies, be they CT, MRI, PET or FDG-PET every single day. Physicians and their staffs are putting in an incredible number of man-hours each week, fighting the system to get what they know to be the best treatment for their patients; treatment decisions based on science, education and experience. Many patients have to routinely obtain a less costly scan, only to have to follow up with what was first prescribed. This is not a cost saving measure but rather a life-threatening measure. Even more challenging is that the clinic must go thru multiple levels of review to achieve a peer-to-peer discussion, which then necessitates the prescriber/provider stop seeing his or her patients to be placed on hold while awaiting the Medical Director of the plan of the insured patient needing the scan to pick up the telephone. How is this even remotely an efficient use of a clinic’s time? In essence, this proposal is actually an impairment to appropriate and timely access to effective care.

Further, in this time of healthcare reform, wherein we are looking for efficiencies in cost that coincide with quality of care, one must remember that FDG-PET scans sometimes allow physicians to give their patients a “drug holiday” versus blindly prescribing additional treatment. PET can show us not only disease which has been shut down with chemotherapy or radiation, but also new growth in those previously treated areas. In short, proper utilization of this FDG-PET can actually reduce versus increase the cost to treat.

We at COA believe and, in fact, are heavily invested in creating the Oncology Medical Home; an environment where acceptable guidelines and standards that will incorporate the judicious use of the all of the tools utilized in the treatment of this insidious disease called cancer. If there are no rules or guidelines, then there are no boundaries, and we truly believe that we need to have those governors if you will, on both the prescriber/provider and his or her plan of care. That said, tying the hands of the individual who has taken the oath to “do no harm” by limiting their ability to prescribe, on an individual basis, what only they know is best for their patient is, in essence, causing the opposite to occur. This is, simply put, bad medicine.

I conclude our comments by stating that COA is committed to finding solutions to strengthening the Medicare program for current and future generations of senior Americans battling cancer. As COA’s newest President, I think you will come to learn that I am a firm believer in not prescribing so much what the patient wants, but rather what the patient actually needs. Over-zealousness may have gotten us to the discussion points we are having here today. Over-reaction, by self-limitation, may take us down a road we perhaps should not have travelled. Any of the COA physicians will make themselves available to you to further discuss more practical ways to limit the use of expensive and unnecessary use of FDG-PET, for who better can speak to the benefit of such scans, than those who are actually treating the tumors in question. We look forward to further discussion to that end.

Sincerely,

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We have seen evidence that PET imaging has gained wide acceptance, and demonstrates broad clinical utility, particularly in oncologic patient care. Our experience suggests that clinicians, following appropriate use guidelines, are best able to manage oncology patient care when using PET/CT, and that it is in fact a more cost effective approach to health systems than previous, conventional methodologies. As such, CMS should consider broad, non-capitated, coverage of oncologic PET/CT in the setting of accredited facilities, which follow evidence-based guidelines. Numerous studies have been published on the global positive impact of this modality upon health care efficiencies, a small sampling is listed below.

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I would like to add my support to the comments posted on behalf of the ACR, ACNM, ASNR, SNMMI and WMIS that have already been published regarding the proposed changes in CMS policy regarding coverage for PET imaging in Oncology. I have been a practicing academic Diagnostic Radiologist and Nuclear Medicine physician for more than 30 years, and have been involved in the performance and interpretation of PET and PET-CT studies throughout the entire time they have been in clinical use, in addition to previous experience with PET as a research technique prior to its introduction into general clinical use. While I endorse all of the opinions expressed in the above commentary, I am particularly concerned about the proposed rigid limitation of coverage for PET and PET-CT imaging to only two studies per patient. As has already been pointed out, this proposal flies in the face of standard clinical management for patients with a variety of neoplasms for which PET imaging has been extensively evaluated and found to be both clinically efficacious and cost-effective. In my practice, the most common indication for PET-CT imaging is in the evaluation of patients with Hodgkin's Disease and Non-Hodgkin's lymphoma. These patients routinely require an initial staging PET-CT study after the diagnosis of lymphoma has been made. This procedure has been extensively shown to be more accurate in the assessment of the extent of disease involvement compared to CT imaging and other clinical assessments alone, permitting an optimized therapeutic approach. In addition, ample published data, both in the imaging and onocologic literature, has clearly established the utility of performing a second PET study early in the course of intial chemotherapy, typically after only one or two cycles of treatment, to assess and predict the response to therapy. This assessment permits a change in treatment strategy in non-responding patients, avoiding unnecessary and unproductive therapy, which would merely add to the cost and morbidity suffered by these patients. At least one additional follow-up study after the conclusion of intital treatment is often necessary to confirm that complete remission has been achieved. Thus, even for patients who respond most favorably to first line therapy, at least 3 PET-CT studies are most often warranted. For patients who do not achieve complete responses from standard therapy or who demonstrate disease progression, further PET examination(s) are essential in assessing the extent of involvement and the response to subsequent therapeutic measures, such as stem cell transplantation, further chemotherapy or radiation therapy or monoclonal antibody therapy. These opinions are not just mine as an imager - they are fully endorsed by my clinical colleagues in Medical Oncology, Radiation Oncology and surgery, who routinely follow these practice patterns to optimize the management of their patients, without any compensation or other ulterior motives for ordering these studies. The scenario is very similar for many other neoplasms for which PET imaging has proven efficacious as well, including, but not limited to non-small cell bronchogenic carcinoma, colorectal carcinoma, malignant melanoma, squamous cell carcinoma of the head and neck, esophageal carcinoma, multiple myeloma and many others.

I fully understand and recognize the need for CMS to explore all avenues for potential healthcare cost savings, especially in the current political and economic atmosphere. However, as an experienced practicing clinician in the field, I sincerely believe that the proposed CMS restrictions on the use of PET imaging in these patients are fundamentally ill-conceived and contrary to evidenced-based clinical practice. As others have indicated, such restrictions are highly likely to adversely affect the management of these CMS beneficiaries and to create massive unnecessary new administrative headaches and losses of productivity, both for CMS and related personnel, practicing physicians and their support staff and patients, their families and other caregivers. Thank you in advance for your consideration.

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April 12, 2013

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Position Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Via Electronic Delivery

Dear Dr. Jacques:

The American Society for Radiation Oncology (ASTRO) and the American Society of Clinical Oncology (ASCO) appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services (CMS) National Coverage Analyses (NCA) on Positron Emission Tomography (FDG) for solid tumors (CAG-00181R4).

ASTRO is the premier radiation oncology society in the world, with more than 10,000 members who are physicians, nurses, biologist, physicists, radiation therapists, dosimetrists and other health care professionals that specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes two medical journals, International Journal of Radiation Oncology, Biology, Physics (www.redjournal.org) and Practical Radiation Oncology (www.practicalradonc.org); developed and maintains an extensive patient website, www.rtanswers.org; and created the Radiation Oncology Institute (www.roinstitute.com), a non-profit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org.

ASCO is the national organization representing over 30,000 physicians and other healthcare professionals specializing in cancer treatment, diagnosis, and prevention. ASCO members are dedicated to treating patients and conducting research that leads to improved patient outcomes, and we are committed to ensuring that evidenced-based practices for prevention, diagnosis, and treatment of cancer are available to all Americans, including Medicare beneficiaries.

We support proposed decision A to remove evidence development requirements for F18 fluorodeoxyglucose positron emission tomography (FDG PET) scans, a recommendation that will reduce the burden of data collection and thus allow patients to more readily receive the benefits of this sophisticated imaging tool in treatment management.

Imaging is an integral part of the diagnosis, initial staging, treatment evaluation and management, and restaging of patients with cancer. FDG PET scans effectively complement and address the limitations of other imaging tools by increasing the sensitivity and specificity of cancer staging to 83% and 91%, respectively, as compared to 64% and 74% for CT scans alone (1). By providing visual illustration of tissue metabolic activity, PET scans assist physicians in determining the extent of cancer and its activity, thus supplying physicians with the necessary data to make informed decisions regarding patient treatment. This has been demonstrated by a number of studies and in the extensive evaluation by the National Oncologic PET Registry (NOPR) of over 250,000 cases. Data collected through NOPR over the past seven years supports the conclusion that FDG PET is both a reasonable and necessary tool for all uses with the exception of surveillance, and thus we conclude should be covered by Medicare benefits as such. ASTRO and ASCO agree with CMS that there is sufficient evidence to demonstrate the benefits of PET and accordingly remove CED requirements.

We disagree with and do not support the proposed limit of one FDG PET scan after completion of “initial anticancer therapy” for all solid tumors, with the exception of prostate cancer which would be non-covered.

If enacted, this proposed decision will significantly impair the ability of physicians to effectively monitor patient responses to treatment and modify therapies as necessary, adversely impacting patient care. This proposal is not reflective of the state of clinical practice or the nature of cancer, which frequently requires retreatment. Indeed, for many cancers, two or more lines of therapy are approved by the FDA and constitute the standard of care. If the rule were to go into effect, it would disadvantage patients for whom initial cancer therapy is ineffective by denying them access to an accurate and effective tool to identify persistent or progressive disease.

Advances in oncology have extensively expanded the treatment options available to patients. For this reason, reevaluation of patients is required at multiple steps throughout a patient’s care, including after a treatment is complete, to assess the efficacy of treatment and determine whether additional treatment is necessary or what the optimal course of follow-up may be. PET imaging provides necessary information to allow physicians to assess the need for subsequent therapy and thus reduce the utilization of potentially ineffective or unnecessary treatments for that patient.

Numerous examples exist to support this point of view but only a few are detailed here. A randomized trial of patients with colorectal liver metastases demonstrated that FDG PET scans provided physicians with the ability to assess the utility of metastatectomy and thus reduced futile laparotomies by 17% (2). Within the field of radiation therapy, PET scans allow physicians treating patients with advanced non-small cell lung cancer to increase total radiation dose to the appropriate sites, reduce exposure to the lungs and esophagus – often the dose-limiting organs for radiation dose escalation – and thus significantly increase the probability of tumor control while reducing the risk of injury to normal tissues (3). The one-scan rule would deny individuals with a recurrent liver or lung metastasis access to the benefits of appropriate PET-guided therapy: either to determine applicable surgical or radiation therapies respectfully. For patients with high-risk metastatic breast cancer, it was determined that FDG PET scans can act as an early predictor of the effectiveness of the first cycle of chemotherapy, thus enabling physicians to avoid persistent use of ineffective chemotherapy regimens (4). FDG-PET scans post-radiation therapy for head and neck squamous cell carcinomas provide physicians with valuable information as to whether a neck dissection is necessary after the completion of radiotherapy (5, 6). Other examples of the effectiveness of PET scans in treatment management can be found in disease sites as diverse as diffuse large B cell lymphoma (7), esophageal cancer (8) and neuroendocrine tumors (9). Patients for whom the first-line of therapy was unsuccessful and for whom subsequent PET scans would be non-covered under the proposed decision, could potentially undergo unsuccessful and costly procedures with possible harmful side-affects. PET imaging can be predictive of therapy outcome, measure the response rate of treatment, and consequently guide physicians to appropriate action in the event of recurrence.

As these examples demonstrate, treating cancer typically requires multiple modalities such as surgery, chemotherapy and radiation therapy. In addition, it is the unfortunate reality that cancer often requires multiple lines of treatment due to the failure of the initial therapy to adequately control the disease. Overall, we believe that the one-scan limit inherently contradicts the reality of cancer treatment which frequently requires multiple specialties to treat patients for persistent or recurrent disease over long periods of time and limits the flexibility of physicians to provide truly personalized cancer care.

While ASTRO and ASCO understand the need to curtail excess utilization of PET scanning that does not inform important clinical decision-making, a national limit is not the appropriate manner in which to do so. The proposed limit is unwarranted and would unnecessarily target all physicians and patients with almost all cancer types uniformly. A policy as generalized and stringent as the one proposed sends the public and Medicare Administrative Contractors (MACs) an inappropriate message that one scan post treatment should be the standard. An indiscriminate policy of this nature does not allow for the variation necessary to treat different disease sites and to individualize patient care. It is our fear that MACs will be blinded by the overall impression of the policy – that one scan is universally sufficient for patient care management after the completion of treatment – and deny all requests for additional scans.

In addition, we anticipate that the proposed limit will create significant clerical complications for MACs, providers and patients. MACs will be inundated with appeals or requests for additional PET scans, generating a considerable administrative burden. This could cause inappropriate delays or denial of requests, resulting in reduced quality of patient care. There is also a strong likelihood of wide discrepancies between local coverage standards. Furthermore, the administrative burden would also be placed on physicians and their staff to process numerous forms from the beneficiaries. But the most troublesome potential effect of this policy could be that patients who need additional PET scans will decline the procedure for fear of the financial consequences of signing the Advance Beneficiary Notice of Noncoverage (ABN). This unintentional outcome could result in the underutilization of a beneficial imaging tool that improves treatment management and patient outcomes. Additionally, this could significantly impact the already existing health disparities in cancer treatment referenced in the proposed decision.

It is our proposal that the one FDG PET scan limit be removed from the proposed national coverage determination policy and replaced with national coverage. MACs retain their right to impose frequency limits through Medically Unlikely Edits (MUEs) or Local Coverage Determinations (LCDs). Providing national coverage would offer beneficiaries the necessary medical advantages of PET scans and be compatible with the complexity of treating recurrent cancers. In the final policy, CMS could recommend a reduction in extensive utilization of FDG PET for surveillance without discrediting the advantages of utilizing such scans for assessing and managing recurrent disease.

We support the proposed decision C to exclude FDG PET for beneficiaries with cancers of the prostate from Medicare coverage nationally. This recommendation reflects the clinical reality that unlike other imaging modalities, FDG PET is not an important tool in the management of patients with prostate cancer.

ASTRO and ASCO support the removal of CED requirements for FDG PET scans but oppose the limit of one scan post initial treatment. If there were a national one-scan limit imposed, there would be confusion among various specialties as to what was considered the “initial anticancer therapy” and an abundant amount of administrative burden would be put on MACs, physicians and patients. In addition, the one-scan limit could increase the utilization of futile costly therapies and reduce the effectiveness of radiation therapy. All in all, the proposed limitation on FDG PET scans will adversely impact patient care, particularly for patients who require additional treatment following failure of the first line of anticancer therapy. We hope CMS reconsiders the one-scan rule and replaces the limitation with national coverage. In addition, we request that the proposed termination date of NOPR data collection requirements occurs in conjunction with the effective date of the final NCD. This will hopefully reduce confusion for providers and smooth the transition from CED requirements to national coverage.

We thank you for your consideration of these comments.

Sincerely,

Laura I. Thevenot
ASTRO, Chief Executive Officer

Allen S. Lichter, MD
ASCO, Chief Executive Officer

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I would like to thank CMS for the proposal to expand solid tumor coverage for subsequent patient management. This expansion will be invaluable for physicians to properly manage treatment of their patients. However, I believe the proposed limit of 1 PET scan for subsequent treatment management is medically inappropriate. Speaking from both a clinical and management position I strongly believe it would be more beneficial and medically appropriate to put in place a more stringent set of guidelines to reduce the amount of PET scans ordered for routine surveillance purposes. This would allow physicians who are currently managing patients with active disease, suspected recurrences, gauging response to treatment, and other similar situations to continue to order PET scan for subsequent treatment management when medically necessary. The decision to push requests for additional subsequent scans down to the local MAC providers would create an administrative burden and very different local coverage standards between regions could result. Another unfortunate effect would be the possibility of facilities requiring collection of ABN forms from patients during their treatment, causing unneeded stress and possible additional financial responsibility for testing that is considered medically appropriate.

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On behalf of Seattle Cancer Care Alliance (SCCA), I am writing to express concern that the March 13, 2013 issued CMS proposed decision to revise the approach to PET scan coverage will significantly impact our ability to effectively manage cancer care and treatment for the types of advanced and unique cancer patients that we frequently treat.

SCCA unites doctors from Fred Hutchinson Cancer Research Center, UW Medicine and Seattle Children’s. Our doctors diagnose and treat thousands of cancer cases every year. In 2012, over 300 oncologists, surgeons, radiation oncologists, and many other clinicians treated over 5,500 patients for many types of cancers including leukemia, lymphoma, breast, prostate, lung, and colon cancer.

As a NCI- designated cancer center, we frequently treat very complex cancer cases. No two patients are alike, and decisions about treatment may need to be made multiple times in a patient’s care. Our physicians may need to use FDG PET imaging more than once in order to effectively manage care for patients with active disease through the course of their treatment. In particular, given that many of our patients have failed first line therapy prior to being referred to us, they tend to have tumors with atypical biology and responses and they tend to be already more physiologically depleted. Therefore they cannot withstand the delivery of an entire course of second or third line treatment without the interval feedback provided by FDG PET as to the global response or heterogenous response of their tumor. Therefore PET is critical to patient monitoring – particularly when a patient is not responding to therapy in a conventional fashion.

We need to provide the flexibility our physicians need to effectively manage the care of our patients for the best possible survival outcomes. The patient and the treating physician, in consultation with an imaging expert, know best the medical question for a patient and whether imaging should be obtained. A proposed limitation to a baseline FDG PET study and another single post-therapy PET scan is grossly insufficient and prevents clinicians from providing optimal treatment for patients with cancer.

We are very cognizant of the cost factors associated with PET imaging. Therefore, we do not order them more frequently than is clinically necessary to inform our treatment strategies. We respectfully request that CMS reconsider the proposed Decision Memo and consider removing the language restricting the use of PET in the management of cancer patient care.

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I am writing as a physician specializing in cancer care, and as a member of several national expert panels on the management of lung cancer including NCCN and ACR.

I applaud the implementation of NOPR-generated evidence to guide coverage of FDG PET for solid tumors. However I strongly disagree with limiting subsequent patient management to a single nationally covered scan. This blanket restriction is arbitrary and inappropriately constrains good clinical practice and expert physician judgment.

I strongly agree with the alternative recommendations outlined in a joint statement of the ACR, ACNM, ASNR, SNMMI, and WMIS that has been posted online at the following link:

Thank you very much for your consideration of this matter.

Sincerely,

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I want to share that I strongly encourage CMS to consider the use of PET technology when diagnosing and restaging cancer. [PHI Redacted] is alive today thanks to a PET scan. Numerous doctors, specialists, etc. could not identify the source of a growing pain in her seliac region. Since she was already a cancer patient they rant CT and Bone tests but nothing was reflected as new or changing. Yet she insisted something was going on in her stomach. Eventually after multiple hospitalizations, her pain specialist ordered a PET scan. It was this test that identified what all of the other tests didn't show, a lymphnode in the seliac region was growing with cancer. She was immediately started on Chemotherapy and continues to fight for her life everyday. She is a Medicare covered individual so for her sake and all other Medicare patients, please allow this kind of life saving treatment to be made available to oncologists.

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I practice community based oncology and hematology. The PET scan in some cases, is irreplacable by other imagings, ie CT or bone scan. Let me give you an example:

I recently treated a lung cancer patient with two cycles of chemotherapy. A re-staging CT scan showed the disease did not response to the treatment. However, I doubt about that and ordered a PET (the third one). The PET scan showed excellent response. Most of the tumors were no longer FDG avid. The PET allows me to make a right treatment decision for the patient.

We are very conscious of the cost of PET. But its usage can't be restricted by an arbitrary number. In the case I described above, if I change the treatment plan based on the CT report, the patient would receive a lot more chemotherapy and toxicities. The cost would also be a lot higher. I strongly against this policy.

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Cardinal Health is pleased to respond to the Centers for Medicaid and Medicare Services (CMS) request for comments relative to Section 220.6 of the National Coverage Determinations (NCD) Manual. The Nuclear Pharmacy Services business of Cardinal Health provides over 12 million nuclear medicine and PET radiopharmaceutical doses annually in the United States. We also provide support for more than 24 early phase clinical trials in nuclear medicine and PET.

We strongly support CMS’s proposed decision to end the data-collection requirements for the remaining cancers included in the FDG National Oncologic PET Registry (NOPR). However, we are concerned with the single scan limit as described in section B of the proposed decision memorandum. Covering one scan, with additional scans at the discretion of the local contractors at the point of Initial Treatment Strategy, is sensible as a newly diagnosed cancer patient will typically only have one “decision node” to determine the best anti-tumor treatment strategy. Applying the same policy to Subsequent Treatment Strategy, however, does not make the same sense. Cancer survivors may benefit from PET more than once in their lifetime after their initial diagnosis, particularly as they are living longer and may receive treatment several times for recurrent cancers. The coverage should be consistent for the patient to receive a PET scan whether they are being evaluated for a suspected recurrence the first or second or third time.

We also believe implementing the proposed policy would be challenging to both the contractors and referring physicians. For example, without clear guidance on whether the FDG-PET scan is covered, providers would need to collect an Advanced Beneficiary Notice of Noncoverage (ABN) from the Medicare beneficiary in case the scan is denied by the contractor. This could delay and/or deter some patients from receiving the FDG-PET scan and eliminate an important diagnostic tool from the referring physician at the time of decision-making. Asking the patient to sign an ABN may also cause undue financial anxiety at a personally difficult time. For the contractors, processing these additional claims on a case-by-case basis would be administratively burdensome and may require additional resources.

The language included in section B of the proposed decision summary requires additional clarification. FDG-PET scans have been covered during the course of treatment for monitoring purposes. Unfortunately, it would seem that this is being eliminated by the use of the phrase “after completion of initial anticancer therapy”. Please provide additional clarification on this point as FDG-PET is often used at this important juncture in the patient’s treatment.

To address these concerns, we suggest replacing the proposed policy framework with the existing policy framework as included in Chapter 13 Section 60 of the Medicare Claims Processing Manual as excerpted below:

• "Restaging: PET will be covered for restaging: (1) after the completion of treatment for the purpose of detecting residual disease, (2) for detecting suspected recurrence, or metastasis, (3) to determine the extent of a known recurrence, or (4) if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is to determine the extent of a known recurrence, or if study information is insufficient for the clinical management of the patient. Restaging applies to testing after a course of treatment is completed and is covered subject to the conditions above.
• Monitoring: Use of PET to monitor tumor response to treatment during the planned course of therapy (i.e., when a change in therapy is anticipated)."¹

Finally, we also respectfully request clarification on the modalities included in the term “PET”. In the most recent final decision on section 220.6 posted by CMS², the term PET was inclusive of PET/CT and PET/MR as shown below. However, in this proposed decision, PET/MR was not included in the term PET. Please clarify this discrepancy. "We include integrated positron emission tomography/computerized tomography (PET/CT) and integrated positron emission tomography/magnetic resonance imaging (PET/MRI) in the term PET."²

In closing, we appreciate the opportunity to comment on this important reconsideration. We support ending the FDG-PET NOPR with the coverage modifications suggested above. Should you have any questions regarding our comment, please contact Terri Wilson at (407) 790-8287 or terri.wilson@cardinalhealth.com.

Sincerely,

Sandra Wisniewski
VP, Marketing, Strategy & Business Development
Cardinal Health
Nuclear Pharmacy Services

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AHIP and our member health plans encourage the use of robust evidence-based research to ensure safe and effective treatments. AHIP's member health plans base coverage decisions on the clinical value of health care services as evidenced by high-quality studies. CMS concluded in the Agency's decision memo that it did not find direct evidence that F18 fluorodeoxyglucose positron emission tomography (FDG PET) improves health outcomes, despite a diligent search. Although CMS did find adequate evidence that the results of an FDG-PET scan will guide physician management for treatment, it is well known that providers' anecdotal experience in guiding their decision-making is often found to be flawed when their experience is subjected to a scientific study. Therefore, our members do not believe that there is sufficient evidence to justify coverage of the test. By using a default principle for coverage decisions, the incentives to develop evidence are reduced and it is difficult to change established practices of care, even when new evidence of ineffectiveness is found. Rather than default to coverage, our members recommend that coverage be withheld until appropriate scientific evidence is available to demonstrate the clinical value of the testing.

Because an evidence review was performed and found inadequate evidence to support a national level coverage policy of FDG-PET scanning for solid tumors, a similar review to support a Local Coverage Determination reviewing the same evidence would undermine the integrity of the national review. Our members believe that allowing the regional contractors to possibly make different decisions on coverage creates inconsistency and does not promote evidence based decision-making. Continuing with the national model will promote uniformity in coverage, preventing confusion among providers and especially patients who may move from one region to another.

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April 12, 2013

Submitted on behalf of the Medical Oncologists of Oklahoma Oncology

I am pleased that CMS has decided to end the CED and NOPR process. Part B of the proposal is cause for great concern. Numerous clinical studies have proven the value and benefit of FDG PET in making initial and subsequent cancer treatment decisions. As proposed, the oncologists’ management of the patient is fettered by potentially having only one more opportunity to use FDG PET for determining the patient’s response to initial therapy. To saddle the local MAC with this decision making responsibility is contrary to good patient care and only increases the burden of an already over-extended contractor. In our experience, this sort of decision making process only leads to greater variability and inequitable care based on nothing other than the region of the country in which you reside. In addition, your proposal places the oncologist in the untenable position of guessing the optimal time for performing the one additional PET. To impose this limitation is to ignore the science that we know about tumor genetics, response/non-response to treatment, and the adaptive response tumors have demonstrated to treatment. Suppose, rather than evaluate the response to therapy after the third cycle, due to the limited options of this policy, the Oncologist decides it better to wait until the end of first line therapy to perform the FDG PET. At that point it is determined that the tumor has not responded to treatment. Had the FDG PET been performed earlier, a change to second line therapy could be made. In this scenario, the patient ended up receiving additional unnecessary and ineffective treatment and CMS reimbursed for this treatment. What is the frequency in changing treatment based on the results of subsequent FDG PET? What was the impact on the patient outcome of this delayed decision? Would the patient’s health and quality of life have been improved with earlier intervention? Does CMS really save any money at the end of the day? We think not.

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. In general, I would like to express my strong agreement with the comments submitted by others, specifically the Joint-Society letter from the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). I would also would like to express my vigorous support for the comments and data submitted by the National Oncologic PET Registry (NOPR) Working Group.

I applaud CMS' proposal to end Coverage with Evidence Development (CED) data collection for the use of FDG-PET for oncologic indications. I strongly agree with the original requestors that sufficient evidence has accrued regarding the substantial benefit in management of patients afflicted by cancer to lift the previous CED requirements.

However, I am surprised and dismayed by several of the components of the recent proposed decision memorandum.

First, I believe that CMS should reverse the proposed non-coverage of prostate carcinoma. While most prostate carcinomas show limited FDG avidity, there are certain subpopulations of prostate cancer patients who have benefitted from, and should be permitted to continue to benefit from, FDG-PET. In particular, FDG-PET has shown substantial utility in patients with castrate-resistant prostate cancer.

Most importantly, I would like to voice my strongest possible opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. We are shocked that CMS proposes the extraordinary step of reversing coverage for post-treatment evaluations that has been in place for the majority of Medicare's cancer patients for years. This proposal represents an inestimable setback in the ability to optimize treatment for millions of cancer patients. We strongly urge that CMS reconsider this portion of its proposal, and remove this restriction from its final decision on the initial request. Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. For many patients, it is the single most important diagnostic modality in managing their treatment. To remove this critical tool from the cancer specialists' armamentarium would have an adverse effect on the care of millions of Medicare beneficiaries. While it is true that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, there a number of better mechanisms to address over-utilization without such draconian measures and without grave consequences for patients who legitimately require FDG-PET imaging for their care.

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully submitted,

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April 12, 2012

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Dear Dr. Jacques:

On behalf of the National Policy Board, physicians and cancer caregivers of The US Oncology Network¹ (The Network), thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed decision memorandum regarding coverage for ¹⁸F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. In addition to the comments below, The Network would like to express agreement with comments submitted by the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). The Network also supports the comments and data submitted by the National Oncologic PET Registry (NOPR) Working Group.

The Network applauds CMS’ proposal to end Coverage with Evidence Development (CED) data collection for the use of FDG-PET for oncologic indications and strongly agrees with the original requestors that sufficient evidence has accrued –in the scientific literature, in the National Oncologic PET Registry (NOPR) trial, and in the daily clinical practice of thousands of physicians caring for cancer patients across the United States – that FDG-PET has substantial benefit in management of patients fighting cancer. FDG-PET allows the visualization of cancer biology in vivo unlike any other imaging modality. Often, its greatest advantages are seen in those patients who would benefit from the most detailed and meticulous management of their disease. The Network is encouraged to have this vital tool available for an expanded population of patients.

The Network is disappointed by several of the components of the recent proposed decision memorandum. Most notably, The Network opposes CMS’ proposal to limit national coverage for subsequent patient management to a single scan, and was surprised that CMS would propose the extraordinary step of reversing coverage that has been in place for the majority of Medicare cancer patients since 2001. If finalized, this coverage policy will degrade physicians’ ability to optimize treatment for millions of cancer patients who rely on Medicare coverage. The Network strongly urges CMS to reconsider this portion of its proposal, and remove this restriction from its final coverage determination. Additionally, CMS should reverse the proposed non-coverage of FDG-PET for prostate carcinoma patients. While most prostate carcinomas show limited FDG avidity, there are certain subpopulations of prostate cancer patients who have benefitted from, and should be permitted to continue to benefit from, FDG-PET.

A. CMS Should Finalize the Removal of CED Requirements.

The successive NOPR trials have added further substantial credence to the fundamental and well-documented principle that the in vivo assessment of glucose metabolic rate utilizing FDG-PET is a well-established cancer imaging method and should be available for use by treating physicians as they determine most appropriate in the management of each individual patient. While cancer is not a uniform disease and FDG-PET does not demonstrate optimal accuracy in every clinical situation across every type of cancer, neither do other imaging modalities with longstanding national coverage, such as CT or MRI. Both cancer clinicians and imaging physicians have actively pursued delineation of the capabilities and the limitations of FDG-PET over the past fifteen years. Through this work there have been developed, and continue to be refined, sets of criteria that attempt to optimize use of the right modality at the right time to answer the clinical question at hand in the specific patient and tumor type being addressed.

The NOPR data have buttressed the knowledge from previously published studies and the daily practice of cancer physicians with clear evidence that FDG-PET makes substantive changes in patient management with exceptional frequency. The vision and foresight demonstrated by CMS and the NOPR Working Group in establishing the NOPR framework has yielded unprecedented value in accumulating data regarding the role of FDG-PET in the management of cancer patients. While these data are not “perfect,” the premise that led to the establishment of NOPR at its inception still stands: there is no ethical way to accumulate “perfect” data regarding an advanced imaging modality in such a complex disease process as cancer. In many cases, imperfect, but strongly suggestive, evidence must suffice. The crucial short-term and intermediate-term question to be asked is whether a test facilitates complex patient management decisions and obviates more expensive or more invasive procedures. One of the primary means by which cancer specialists deal with the complexities of their clinical decisions is by regimented guidelines or frameworks for patient management, based on a wide array of clinical, laboratory, and imaging factors. That FDG-PET results in such a high number of changes in patient management is a testament both to the clinical power of the relatively simple (in molecular imaging terms) tool of imaging glucose metabolism and to the judgment of the referring physicians in utilizing FDG-PET appropriately. There remains no further justification for CMS to continue to impede the clinical use of this unique cancer diagnostic tool by restricting its coverage for Medicare beneficiaries.

B. CMS Should Reverse its Proposal Regarding Non-Coverage of Prostate Cancer.

CMS should reverse its proposal to exclude prostate cancer from FDG-PET coverage in response to the data and conclusions presented in the Joint-Society comments submitted by the American College of Radiology (ACR) and others that CMS has not appropriately accounted for publications in the current literature that demonstrate the value of FDG-PET in specific populations of patients with prostate cancer.

Most prostate cancers are poorly FDG-avid and are, therefore, poorly imaged with FDG-PET. This means that FDG-PET has limited value in initial diagnosis and initial staging in the vast majority of prostate cancer patients, or in patients who demonstrate the typical clinical course of castrate-sensitive disease. However, this limitation of FDG-PET is well known to both the clinicians and the imagers participating in these patients’ care. Cancer physicians are not just interested in having more information. Their daily lives are flooded with information. What they are interested in is useful information, and they are clearly fluent in these basic concepts of FDG-PET in prostate cancer. These physicians are well aware that the positive predictive value of a positive FDG-PET result in a patient with prostate cancer is substantially higher than the negative predictive value of a negative result. In The US Oncology Network, one of the largest in the nation, FDG-PET has been used sparingly in prostate cancer, as Network physicians are fully apprised of the limitations of FDG-PET in most such cases. That this knowledge is broadly held and appropriately influences ordering patterns is evidenced by the very low percentage of Medicare prostate cancer patients who have been imaged under NOPR. It is in both the patient’s and the physician’s best interest to order an FDG-PET study for prostate cancer assessment only when it is reasonably likely to yield accurate and important information. The fact that such a high percentage of the scans performed in prostate cancer patients under NOPR led to a significant change in patient management shows that these patients’ physicians can make such distinctions with a high degree of certainty.

The Network most strenuously disagrees with the proposed non-coverage of prostate cancer in the treatment follow-up of men with aggressive, castrate-resistant prostate carcinoma. FDG-PET provides crucial biological information in this group of patients that cannot be gleaned from other, currently approved, imaging modalities. Although other PET tracers, such as ¹¹C-choline, will almost certainly prove to be of even greater value in such patients, the extremely limited availability of this tracer for clinical studies makes it unavailable to the overwhelming majority of prostate cancer patients who could benefit from PET imaging. And, given the difficulties inherent in the New Drug Application (NDA) process and technical difficulties regarding synthesis and distribution of 11C-choline, its availability to prostate cancer patients is highly likely to remain extremely limited for years to come. Thus, the utility of the widely available FDG remains of tremendous interest.

The FDG uptake of prostate cancer metastases can be useful in delineating castrate-sensitive vs. castrate-resistant tumor populations – a distinction crucial in both treatment selection and prognostic evaluation. FDG-PET also offers details regarding extent of metabolically active disease in aggressive tumors that may well alter treatment selection. Most importantly, the therapeutic options for castrate-resistant patients are substantially more limited and, often, more toxic. As with many other tumors, therapeutic options are increasing, but, in many cases, so are their costs and morbidities. Earlier and more accurate identification of such patients with FDG-PET will likely increase the success of these new agents, when utilized. In addition, early assessment of treatment efficacy is the best means by which to avoid needless expense and toxicity. Of generally available imaging modalities, FDG-PET stands alone in its ability to determine treatment response in such aggressive, typically FDG-avid tumors. Therefore, based on the data published in peer-reviewed literature and, in particular, based on the data presented by the NOPR Working Group, The Network believes that FDG-PET should be covered for patients with known or reasonably suspected castrate-resistant prostate cancer.

Finally on prostate cancer, there is another potential source of confusion that may result from a global policy of non-coverage for this very common cancer. This involves another special subpopulation of prostate cancer patients: those with prostate cancer and another known or suspected cancer. In the Medicare age group, multiple cancers are encountered with unfortunate frequency. A lung nodule in a patient with prostate cancer may well be a primary lung cancer, rather than prostate cancer metastasis; abdominopelvic adenopathy may be lymphoma, not metastatic adenopathy. This patient subpopulation overlaps with, and is similar to, that of castrate-resistant prostate carcinoma, in that an FDG-avid lesion is more likely to portend a more aggressive lesion (whether prostate-derived or not) and a poorer prognosis; therefore, positive lesions on PET merit more aggressive evaluation. Global non-coverage of prostate cancer will lead to confusion in many such cases and result in denials or delays in care of patients with additional, potentially curable cancers.

C. CMS Should Reverse its Proposal Regarding One-Scan Limit for Subsequent Care Management

For physicians and patients, CMS’ proposal to limit subsequent therapy management to one FDG-PET scan is the most problematic portion of the proposed decision memorandum. The Networks agrees with the objections of the ACR et al to this proposed limitation on procedural, clinical, and practical management grounds.

The language of the proposed decision memorandum is unclear. While The Network would oppose a one-scan limit policy for the tumors included in the current request for coverage, CMS did not limit its non-coverage proposal to those specific tumors. Instead, The Network’s interpretation of the language of the proposed memorandum to include all tumors for which FDG-PET is covered, which would affect the vast majority of patients who have been covered for multiple “therapy monitoring” or “restaging” FDG-PET studies for years. The scope of this proposal is over-reaching, unnecessary, and unjustified, and will degrade the care of millions of patients.

On a clinical basis, The Network opposes this facet of the proposed decision, which would create a major void in the armamentarium of cancer physicians. Without citing appropriate justification, the proposed decision creates new coverage limitations that, while potentially workable for some patients, will severely hamstring the management of millions of additional patients. Not only are there no correlative data to support this discontinuation of coverage for millions of cancer patients, but the argument for such a limitation is, prima facie, illogical, given that CMS continues to recognize the value of one post-treatment FDG-PET. In the current world of cancer care, to state that this biologically-based modality has utility in treatment follow-up after initial therapy and to then deny coverage for subsequent treatment strategy is a gross clinical contradiction.

While it would be an excellent result if every Medicare cancer patient could undergo a single FDG-PET for optimal treatment planning and a single post-treatment FDG-PET to document that the tumor has gone into complete remission, that is not the reality facing Medicare beneficiaries fighting cancer. Many patients fight through clinical courses that necessitate multiple FDG-PET scans for appropriate management. Many of those fail their first-line therapies. Sometimes that failure is clinically apparent; sometimes it is only discovered on the first follow-up FDG-PET. Either way, they will likely require second-line or third-line therapies, with subsequent FDG-PET studies required to assess treatment response to those therapies. Other patients will show adequate response to initial therapy, but will subsequently demonstrate symptoms, signs, laboratory values, or imaging results suspicious for recurrence – or, perhaps, for a second primary tumor. In many of those cases, FDG-PET imaging is the most appropriate means by which to diagnose recurrence or to at least triage those patients for aggressive evaluation or conservative management. If those patients are subsequently treated for recurrence, then FDG-PET will, once again, be necessary to assess for response to that therapy. Unfortunately, many cancer patients will suffer through a number of such setbacks of recurrence or progression, requiring additional therapy and additional therapeutic efficacy assessment, during their lifetimes. FDG-PET has tremendous documented value in these complicated cases, many of which demonstrate post-therapeutic changes on CT or MRI that make recurrent or progressive tumor extremely difficult or impossible to detect. For these reasons, current treatment and re-treatment guidelines for a variety of malignant tumors recommend multiple FDG-PETs for subsequent treatment strategy over the course of the disease. To propose that FDG-PET is merited for a single post-treatment scan after initial treatment, but not for subsequent treatment assessment after additional therapy does not make sense.

In addition, the language of the current proposed decision appears to non-cover all therapy monitoring FDG-PET scans performed while the patient is undergoing treatment. This also runs counter to data in the literature and to the daily clinical experience of Network physicians. Many patients may seem to be responding to their first- or second-line therapies, but show debilitating or life-threatening toxicities from those therapies. It can be a tremendously difficult decision, for both physician and patient, as to whether to risk continuing therapy or to modify that therapy. In addition, as more innovative therapeutic modalities have emerged, cancer patient survivals are extended and more and more patients are undergoing multiple different treatment regimens during their prolonged clinical courses. These new therapies do not come without cost, in terms of both money and patient morbidity/mortality; monitoring of therapeutic effect during therapy obviously becomes even more important with increasing cost and/or increasing toxicity. FDG-PET has shown distinct advantages over anatomic imaging modalities in assessing therapeutic efficacy on interval scans, which can allow for a more accurate, safer, and more cost-effective decision-making process in such patients. If it is, indeed, CMS’ intention to non-cover such studies during treatment, then The Network strongly urges CMS to reconsider this decision.

There have been concerns regarding the quality of the data in the literature addressing the effect that FDG-PET may have on patient management and, more to the point, patient outcomes. Since the early days of PET reimbursement, it has been recognized that it is difficult, if not ethically impossible, to apply the same standards of data-gathering to a complex imaging modality in a very complex group of patients as one might to a new antibiotic in a well-defined population of patients with a specific bacterial infection. That realization is part of what led CMS to the initial standard of approving the use of FDG-PET when it had a reasonable likelihood of replacing or preventing other imaging tests or more invasive procedures and to the subsequent development of the NOPR trials to ascertain the effects of FDG-PET on more immediate patient management.

Despite numerous regulatory and reimbursement hurdles, FDG-PET (especially PET/CT) has become a major tool, relied upon by cancer physicians for making some of the most difficult decisions regarding patient management. Many of these physicians were not easily convinced. Faced with a complex, sometimes not readily available modality that produced images that were not as anatomically understandable as the CTs and MRIs to which they were accustomed, many cancer physicians were slow to adopt FDG-PET. For the most part, however, even the most PET-resistant among them, are now convinced of the value of this technique in cancer management. As further evidence that FDG-PET has superseded other modalities in both therapy monitoring and restaging, an increasing number of multi-center clinical trials and vendor-sponsored clinical trials of new therapeutic modalities are requiring FDG-PET for such determinations in enrolled patients.

A healthy skepticism regarding the advantages and disadvantages of any complex test or therapeutic strategy is, of course, always in order. For example, as discussed above for castrate-sensitive prostate cancer, there are clearly specific tumors and specific patients for which FDG-PET may have little or no value. However, this is the oncologic PET exception, rather than the rule, and CMS continues to hold FDG-PET to a far higher standard than other diagnostic or therapeutic tools. In this regard, CMS should look at the totality of the published literature, rather than continue to search for the perfect or near-perfect data.

The clinical value of FDG-PET in cancer management has been proven scientifically and, especially, clinically on a daily basis since its first approval. Physicians, especially those making major, and potentially dangerous, decisions regarding cancer treatment, are not interested in inaccurate information just for the sake of having more information. Such imaging studies or laboratory values not only clutter the landscape through which the clinician must envision his/her appropriate treatment course, but they also introduce medicolegal and ethical issues, whether the clinician acts on them or not. Network physicians order FDG-PET studies not because they can, but rather because such studies are invaluable in patient care.

Based on the language contained in the proposed decision memorandum, it appears that CMS believes that a large percentage of subsequent treatment planning FDG-PET studies are currently being performed for surveillance. The Network respectfully disagrees. CMS has made it clear from the earliest days of PET coverage that surveillance is not an approved indication and Network physicians have incorporated that into their ordering parameters for over a decade. While use of FDG-PET for surveillance of patients with tumors who might benefit from the earliest possible detection of potential recurrences is a matter that could be debated, that clearly would be a discussion of more limited scope. For the purposes of the current discussion, The Network would readily support codification of the present and longstanding proscription against use of FDG-PET for surveillance of asymptomatic patients in clinical remission with no other signs of recurrence. However, to deny the appropriate and necessary use of FDG-PET in those patients who do have such legitimate indications for such a scan is clearly a case of throwing the baby out with the bathwater. The very reason that FDG-PET has been so widely adopted for treatment follow-up is that physicians caring for cancer patients readily see the advantages of FDG-PET, especially PET/CT, over previously standard modalities, such as CT or MRI. Oncologic questions of therapy response, progression, or regression are typically answered sooner and more accurately, with fewer total imaging procedures, when FDG-PET is used appropriately. If this critical tool is no longer available, then the physicians caring for this growing population of patients will be forced to order an ever-increasing number of other additional tests and/or even more costly invasive procedures, in order to answer these questions. While the concerns of over-utilization of any imaging or therapeutic modality are real, placing such severe restrictions on the use of PET in the reevaluation of these complicated patients is shortsighted and will lead to a much larger, compensatory, increase in expenditures elsewhere. Much worse, without the ability to assess early treatment response or to establish new baselines of tumor burden before and/or after second-line or third-line therapies, these unfortunate patients will be subjected to needless, expensive, and toxic therapies that may have been avoided by the appropriate use of FDG-PET.

D. CMS Should Reverse its Proposal to Place the Burden of Coverage Decisions for Additional Subsequent Treatment Strategy Scans on the MACs.

The option of having the MACs consider approval of coverage on a tumor-by-tumor or case-by-case basis is untenable on administrative and, subsequently, clinical grounds. This would be a tremendous administrative burden for the MACs, resulting in a costly and time-consuming review process. Even if each MAC makes a tumor-wide policy for each tumor, that means that each organization will be required to review coverage that has already been reviewed, established on the basis of unrefuted data, re-reviewed, and supported by the NOPR trials. This will require a tremendous amount of time, effort, and money on the part of the MACs and on the part of the oncologic and PET medical communities. No doubt, many patients will fall through the cracks while all these considerations are under way. Also, if each MAC comes to different conclusions, this will lead to a great deal of confusion regarding regional differences in this critical coverage. Even more concerning, the MACs likely will be tempted to interpret the national non-coverage of such studies as definitive, or at least as the default position, which means that every such case would have to be decided on an individual basis. The time and personnel costs on both sides of the approval process would be inestimable. Indeed, given the budgetary and staffing constraints of the MACs in the current environment, the flood of requests and appeals resulting from such a reversal of coverage could well foster pre-approval and appeal backlogs, resulting in delays in care not only for FDG-PET patients, but also for patients being scheduled for other diagnostic or therapeutic procedures.

Given this new uncertainty and the time constraints under which many oncologic management decisions must be made, many physicians and cancer patients will be unable to wait for such approvals and appeals to run their lengthy course. In such cases, PET imaging providers will have no choice but to require that such patients complete Advance Beneficiary Notification (ABN) forms before performing scans that are clearly medically necessary. These patients will then be faced with very difficult decisions regarding whether to take on the added expense of an FDG-PET scan or to refuse their physicians’ best recommendations regarding their care. For millions of patients previously treated or currently being treated for cancer, this could well mean a choice between footing additional expenses that they can scarcely afford or abandoning the single imaging tool that has been most valuable in guiding their past treatment. Even worse, many referring physicians will simply give up on the FDG-PET approval process and will simply order repetitive CTs or other tests that are less accurate, but easier and quicker to obtain, especially when facing an urgent clinical decision. It would be these virtually inevitable outcomes that would turn this administrative nightmare into a major clinical setback for millions of cancer patients. While FDG-PET is not perfect – no test is – it cannot be rationally argued that cancer physicians should be forced to revert to less accurate imaging tests or to more invasive reassessment techniques for patient management. Such an approach will clearly lead to increased costs and poorer patient management.

Understanding the appropriate incorporation of FDG-PET imaging into oncologic patient management, and the development of an appropriate reimbursement framework for such imaging, has been a long and arduous process. The oncology and PET communities appreciate the efforts of CMS in this process, especially its efforts in the establishment of the NOPR trials and the subsequent assessment of the critical data provided by NOPR. The Network specifically supports the current proposal to conclude the CED process for oncologic PET and proceed to national coverage for oncologic PET.

However, The Network has serious concerns about the proposed non-coverage of prostate cancer, as there is a small, but significant percentage of these patients that would benefit substantially from FDG-PET imaging and for whom there is not another practically available imaging test of similar value.

Most importantly, The Network has grave concerns regarding the proposed one-scan limitation for subsequent treatment planning. Again, while recognizing the limitations of data in this field regarding patient outcomes, the combined strength of the clinical experience and scientific data with this unique tool for assessing tumor activity is undeniable. The findings of the NOPR trials reinforce the major role that FDG-PET can and does play in management of cancer patients. This modality should be available for use by cancer physicians for management of their patients with all types of cancer, for both initial and subsequent treatment planning, without the undue restrictions in the proposed decision memorandum.

Thank you for the opportunity to comment on this important policy question.

Sincerely,

/s/
Thomas Flynn, MD
Chairman, National Policy Board

/s/
Landis Griffeth, MD, PhD
Director of Functional Imaging

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To Whom It May Concern,

I am a radiation oncologist who specializes in pancreatic and rectal cancer at Johns Hopkins. I obtain PET/CT images on all of my pancreas and rectal cancer patients at baseline to 1) ensure patients don't have metastatic disease, 2) assist with radiation treatment planning, and 3) to provide a baseline comparison scan to assess treatment response to radiation therapy. I also order repeat PET/CT images when patients have suspicious areas that may indicate recurrent disease following radiation treatment or surgery. I rely heavily on these images and I know that PET/CT images have prevented me from unnecessarily treating patients with radiation therapy (when patients have metastatic disease) or undergoing a surgery that would not benefit them (Whipple and rectal surgery). I am very worried that a lifetime limit ofPET/CT scans will severely limit our ability to manage patients with rectal and pancreatic cancer and result in unnecessary procedures (radiation and surgery) that can otherwise cause toxicity and harm to patients. We have data that outline the utility ofPET/CT in these malignancies. Our results have been presented at national meetings, and we are in the process of submitting several manuscripts. As opposed to setting a lifetime limit on PET imaging, I recommend patients first have a baseline scan. If the tumor fails to demonstrate FDG-avidity, then future PET scans are unlikely to be of benefit. Therefore, these patients will not require future PET imaging. Alternatively, patients that have tumors that are FDG avid should be able to have PET images when needed to assess response and/or differentiate benign from malignant findings. If we place a lifetime limit on PET images, it will also force us to biopsy suspicious lesions which could also result in additional toxicities for patients. Please feel free to contact me with any questions or concerns.

Sincerely,

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The proposed limit on PET scanning is arbitrary and does not address the needs of patient's with malignancies. It assumes that a patient suffers only one malignancy per lifetime. For example, patients with head and neck cancers are also at risk for developing lung cancers. If such a patient was to to have a PET for staging and a PET for treatment response of their head and neck cancer, PET would not be available for the potential diagnosis (e.g. solitary pulmonary nodule), staging, and treatment response of a subsequent lung cancer. Please do not limit patient's access to this critical technology.

Michael Kasper, M.D.
michael.kasper@ usoncology.com
6204 Balcones Drive
Austin, Texas 78731

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April 12, 2013

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Dr. Jacques,

While our large multi-disciplinary oncology and hematology practice appreciates the fact that CMS has broadened the coverage for PET imaging for specific tumors, which provides benefit for many of our patients, we feel that is it important for us to relay to you the serious adverse effects that the recent proposed limitation of coverage for PET imaging will cause for our patients in their treatment strategies.

We believe that this proposed limitation of coverage of PET scans will lead to additional invasive and non-invasive patient surgical and medical procedures to confirm or rule out cancer. Also, the additional alternative imaging that will almost certainly be required at shorter intervals, will negate any cost benefit of reducing coverage of PET scans as proposed. The additional alternative imaging will put our patients at risk of complications arising from excessive radiation exposure, avoidable surgical and medical procedures, and also will interfere with treatment strategies and delayed diagnosis of recurrence and progression.

The proposed policy is arbitrary and capricious. This proposed limitation of coverage makes no provision for patients with recurrent cancer, nor for those with decreased but persistent findings with CT imaging (such as patients treated for lymphoma), where PET scan findings do provide the necessary and important information needed as to whether or not the patient requires further treatment.

We realize that PET scans are not approved for surveillance of asymptomatic patients. But, we would like to emphasize that PET scans are vitally important for patients with cancer in the post-therapy setting for the assessment of treatment efficacy, or for the evaluation of suspected recurrence or progression. From our perspective as Medical Oncologists, Radiation Oncologists, Gynecologic Oncologists, Hematologists and Breast Surgeons we firmly attest to the fact that FDG-PET is a well-established cancer imaging method that should be available for use by the treating physician, as they deem necessary, for the management of patients with all types of cancer.

Sincerely,

Roger M. Lyons, MD, FACP
Practice President

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On behalf of the Ovarian Cancer National Alliance (Alliance), we thank you for the opportunity to comment on the Centers for Medicaid and Medicaid Services’ (CMS’s) proposed decision memo regarding coverage of FDG-PET scans (PET) in solid tumors. In these comments we will use PET and PET/CT interchangeably. The Alliance advocates for policies, programs, and investments to support the development of an early detection test; improved health care practices; access to life-saving therapies; and improved awareness among health professionals and the public of the risks and symptoms of ovarian cancer. Too many women are unaware of their risk of developing ovarian cancer; tens of thousands each year are diagnosed too late and, therefore, lose their lives unnecessarily. It is our mission to improve these outcomes.

Ovarian cancer is the deadliest gynecological cancer. According to estimates from the American Cancer Society, in 2013 approximately 22,240 new cases of ovarian cancer will be diagnosed and 15,500 women in the U.S. will die from ovarian cancer. Ovarian cancer mortality rates have remained virtually unchanged for nearly 40 years, while we have seen improvements in many other cancer types. The majority of women have at least one recurrence, which may be detected by the presence of ovarian cancer symptoms, by rising levels of the CA-125 blood marker or by imaging.

• According to Hillner et al., 36% of PET scans led to a change in treatment plan.
• In Risum et al., PET was shown to help discover distant metastases of ovarian cancer, which can affect the course of treatment.
• Of the 4,500 ovarian cancer patients who had PET scans through the NOPR, more than 40% had a change in treatment decision based on the results of a PET scan.
• In Mangili et al., patient management was affected in 44% of patient with suspected recurrence of ovarian cancer.

• How confident are you that the evidence is adequate to conclude that FDG PET imaging improves physician decision making when used for the following indications for each in these nine cancers?
  • For Diagnosis: MEDCAC members indicated relatively stronger confidence in FDG PET effect on physician decision making in the diagnosis of ovary and pancreas neoplasms (3.0 and 2.75 respectively).
  • For Staging: MEDCAC members indicated relatively stronger confidence in FDG PET effect on physician decision making in staging of cervix, ovary, and pancreas neoplasms (3.5, 3.5 and 3.25 respectively).
  • For Monitoring: MEDCAC members indicated relatively stronger confidence in FDG PET effect on physician decision making in monitoring of cervix and ovary neoplasms (both at 3.5).
• How confident are you that the evidence is adequate to conclude that FDG PET imaging improves patient oriented clinical outcomes when used for the following indications in each of these nine cancers?
  • For Diagnosis: MEDCAC members indicated relatively stronger confidence in FDG PET performance for diagnosis of ovary, pancreas and kidney neoplasms (3.25, 3.25 and 2.75 respectively
  • For Staging: MEDCAC members indicated relatively stronger confidence in FDG PET performance for staging of cervix, ovary and pancreas neoplasms (3.75, 3.5 and 3.5 respectively).
  • For Restaging: MEDCAC members indicated relatively stronger confidence in FDG PET performance for restaging of cervix and ovary neoplasms (both at 4.25).
  • For Monitoring: MEDCAC members indicated relatively stronger confidence in FDG PET performance for monitoring of cervix, ovary and kidney neoplasms
  • (4.0, 3.75 and 3.5 respectively).

In most cases, a woman’s tumor will emit the CA-125 protein, which can be measured to monitor for recurrence. However, in some cases, a woman’s tumor does not emit this protein at all. In those cases, imaging, including PET, may be the only way to determine if a woman is having a recurrence of her ovarian cancer. Additionally, there may be instances when the CA-125 test and other tests contradict or provide medical uncertainty. In these cases, a PET would be required to accurately understand tumor recurrence/proliferation.

Additionally, using PET to stage may help determine the course of treatment. For example, distant metastasis may preclude the use of intraperitoneal therapy, often the standard of care for gynecologic-oncologists, or determine if a patient requires neoadjuvant therapy. It may also help identify secondary cytoreductive surgery that often translates into improved survival and quality of life.

While the cost of a PET may vary, an institution is reimbursed approximately $1500 by CMS per scan. Should a PET not be covered, the cost may be higher for a patient; even if it is not this is a significant burden for most cancer patients.

The Alliance, therefore, is concerned that Medicare Administrative Contractors (MAC) could exercise undue discretion and/or create regulatory barrier to access. The Alliance respectfully requests that in patients whose tumor does not emit the CA-125 protein, these patients be granted some sort of blanket approval for appropriate imaging as it will always be medically necessary. There is no need for a patient to repeatedly provide the same information to the same MAC regarding the same medical condition. The Alliance further recommends that medically necessary be defined, in the case of ovarian cancer, as included but not limited to situations in which medical uncertainty exists. This may also include some limit on how many PET scans are reasonable and safe for a survivor to receive per year. Thirdly, the Alliance recommends that administrative burdens be minimized for patients whose providers have determined that a PET scan is the appropriate tool to determine the best course of treatment. Lastly, the Alliance recommends that outcomes data be collected and analyzed to determine if PET truly helps provide quality care.

The Alliance is grateful for the opportunity to comment and stands ready to work with CMS further on this issue.

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April 12, 2013

Jeffrey Roche, MD, MPH
Lead Medical Officer
Stuart Caplan, RN, MAS
Lead Analyst
Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Roche and Mr. Caplan:

The Association of Community Cancer Centers (ACCC) appreciates this opportunity to submit comments on the proposed decision memo for positron emission tomography (PET) for solid tumors (CAG-00181R4).¹ ACCC represents more than 17,000 cancer care professionals from approximately 900 hospitals and more than 1,200 private practices nationwide. It is estimated that 60 percent of cancer patients nationwide are treated by a member of ACCC.

Similar to the Centers for Medicare & Medicaid Services (CMS), ACCC is committed to improving health outcomes for Medicare beneficiaries. As advocates for patients battling cancer, we recognize that continued coverage for the use of cancer detection tools can literally make the difference between life and death.

CMS proposes to end the coverage with evidence development (CED) requirement for F¹⁷ fluorodeoxyglucose positron emission tomography (FDG PET) scans for oncologic indications under §1862(a)(1)(E) of the Social Security Act (SSA) that is contained in section 220.6.17 of the Medicare National Coverage Determinations Manual. This change would remove the current requirement for prospective data collection by the National Oncologic PET Registration (NOPR). CMS also proposes that one FDG PET scan will be covered under §1862(a)(1)(A) of the SSA when used to guide subsequent physician management of anti-tumor treatment strategy after completion of initial anticancer for all cancers except those of the prostate. The proposed new coverage decision would grant local Medicare Administrative Contractors (MACs) the authority to determine whether coverage should be provided for additional FDG PET scans used to guide subsequent physician management of anti-tumor treatment strategy.

ACCC supports CMS’s proposal to end the CED requirements for these uses of FDG PET after several years of data collection and analysis, but we are concerned that the proposed decision will limit access to reasonable and necessary scans, including scans for indications not currently subject to CED. By specifying that the NCD covers only one scan for the subsequent physician management of anti-tumor treatment strategy, with coverage of any additional scans determined by the MACs, the proposed decision could be interpreted as suggesting that additional scans generally are not reasonable and necessary. If implemented, the proposed decision coverage for FDG PET scans for solid tumors would be a significant setback for oncology practices. Oncologists are only just beginning to utilize FDG PET scans for making appropriate therapy decisions based on early treatment response, and the proposed coverage decision would substantially impede adoption of this beneficial practice in this area.

Coverage concerns among doctors and patients as well as the lack of uniformity among MACs in providing coverage for these FDG PET scans could jeopardize patient care. Physicians treating cancer patients should be able to exercise their professional medical judgment to determine whether an additional FDG PET scan is necessary for guiding subsequent physician management of anti-tumor treatment strategy without having to worry that the scan might not be covered under Medicare. If coverage is uncertain, patients and physicians may be deterred from using medically necessary FDG PET scans due to potential financial liability for the scan. In addition, new barriers to ordering FDG PET scans will have the unintended consequence of causing oncologists to order substantially more, and less helpful, computed tomography and magnetic resonance imaging scans.

We also are greatly concerned about the broad scope of this proposed decision memorandum. While some language in the proposed decision memorandum indicates that its scope is limited to those oncologic uses of FDG-PET scans to guide subsequent anti-tumor treatment strategy that are currently covered only under CED, the plain language of the decision and the Proposed National Coverage Determination Manual Language at Appendix C suggest that this decision will apply to all forms of cancer except those of the prostate – even those cancers which are not currently subject to CED requirements. Medicare currently does not have a one-scan limit on FDG PET for the subsequent treatment strategy for indications not subject to CED. The proposed decision memorandum does not provide evidence supporting a change in the coverage policy for FDG PET scans for cancers that are not currently covered under CED, and a change in the FDG-PET scan coverage policy for all cancers would have a profound impact on the health care system.

Unlike the similar limit to one scan per patient per cancer for initial treatment strategy, where there are few exceptions requiring local carrier approval, there are many circumstances warranting repeat scans for subsequent treatment strategy. Lymphoma is a prime example: patients have a scan for treatment monitoring after two to three cycles of chemotherapy (which increasingly is leading to treatment adaptation), then have a restaging scan after the completion of chemotherapy, and then are restaged when they return with a suspected or documented recurrence. Under the proposed decision, only the first scan would be covered for all patients. Coverage of additional scans would be determined by local contractors and could vary from jurisdiction to jurisdiction. Furthermore, the proposed coverage decision does not distinguish between FDG PET scans provided after completion of initial anticancer therapy and those provided due to a recurrence or suspected recurrence. As a result, the proposed coverage decision suggests that any FDG PET scans used to guide treatment due to a recurrence or suspected recurrence will be subject to MAC approval. MACs will undoubtedly be overwhelmed by the sheer volume of decisions that they will be required to make to address these circumstances.

Instead of the proposed approach to coverage, we urge CMS to adopt the coverage policy in effect for cancers not currently subject to CED: colorectal, breast, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, ovarian, cervical, and myeloma. FDG-PET is currently approved for subsequent treatment strategy for these cancers but is not limited to a single scan. This coverage policy should be adopted by CMS for all cancers, including cancers currently covered under CED. We also urge CMS to reconsider its proposed noncoverage policy for FDG PET for prostate cancer and allow it to be covered on the same basis as FDG PET for other cancers.

ACCC greatly appreciates the opportunity to submit comments on this important matter. If you have any questions about our comments, please contact Matthew Farber, Director, Provider Economics and Public Policy, at 301-984-9496, ext. 221.

Sincerely,

/s/
Virginia T. Vaitones, MSW, OSW-C
President
Association of Community Cancer Centers (ACCC)

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To whom it may concern;

I am the chief radiologist for a multi-specialty cancer physician group. I have worked in hospital and out-patient facilities prior to my 8 years in this practice. I am in a unique position as I interact with patients and various cancer specialists on a daily basis. I always have tried providing the best patient care possible and have been a leader in my field.

I am aware and understand the governments concerns about the use of inappropriate health care spending / utilization. I am also aware of the costs and clinical value of various radiology procedures. In this regard, I am very concerned/distraught over the suggestion that PET/CT scans will be limited to 2 per patient (initial and therapeutic response). Cancer is not a one and done disease. No one is ever really cured physically or mentally. Medicine used to believe if you survived 5 years you were cured. What we have since learned is that in many instances we didn't have the tools to find a recurrence till after 5 years. Also that the therapy a patient got , put them at risk for other cancers that took time to develop.

In particular , PET/CT has improved cancer care not only by finding the cancers but MORE importantly to determine if the therapy is working. This ability to observe response , or more importantly observe no response is what has changed cancer survival. Because we can intervene in time to change therapy. This intervention improves the patients quality and length of survival and decreases costs by eliminating the thousands of dollars spent on inappropriate/non-successful therapy ( chemo/radiation) .

I am also aware that a lot of care ( including radiologic procedures) add little to no benefit to the entirety of patient care. With my expertise, I am willing to assist you to help determine more appropriate pathways / utilization of patient care .

Thank you,

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I would like to express my objection to the proposed changes limiting the number of PET scans that an individual patient can have during his lifetime. There are many times where the information gained from a PET scan is valuable in making decisions as to whether patients have responded to therapy or have recurrent disease. Information from such scans can be used to decide whether or not a patient should have a biopsy procedure or just be observed. Although classically this is at presentation, there are many instances where this information is needed in later lines of therapy, particularly in lymphoma and colon cancer. Please reconsider your plans.

Sincerely,

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Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

RE: Comment on Proposed Decision Memorandum for Positron Emission Tomogrpahy (FDG) for Solid Tumors (CAG-00181R4)

Dear Dr. Jacques:

Siemens Molecular Imaging appreciates the opportunity to comment to the Centers for Medicare and Medicaid Services (CMS) on the proposed decision memorandum to revise the current coverage status of FDG positron emission tomography (FDG PET) at Section 220.6 of the Medicare Coverage manual.

Siemens Molecular Imaging develops vertically integrated solutions that include innovative imaging biomarkers, preclinical and clinical imaging equipment and software applications, and is a Business Unit within Siemens Healthcare, the global healthcare sector of Siemens AG.

Siemens Molecular Imaging strongly supports the National Oncological PET Registry's (NOPR) request to end the Coverage with Evidence Development (CED) data collection for the use of FDG PET. However, we urge CMS to reconsider the proposal that FDG PET coverage for subsequent patient management be limited to one covered scan and to reverse the proposal to not cover prostate cancer. We believe that this proposal will have an adverse impact on Medicare beneficiaries' access to this important diagnostic tool and hinder physician's ability to manage oncologic treatment effectively.

We are requesting that CMS

1. Finalize the removal of CED requirements


2. Remove the one scan limit


3. Reverse the proposal on non-coverage of prostate cancer

The primary objective of the NOPR was to measure the impact of PET on the referring physician's intended patient management. Since April 2009, complete data have been submitted for approximately 139,000 scans in the second phase of the NOPR.¹ Prospective data collection on FDG PET through NOPR has provided robust data demonstrating the clinical value and efficacy of FDG PET. Therefore, we are pleased that CMS has proposed to finalize the removal of CED requirements. This decision will benefit patients with solid tumors and their treating physicians by providing FDG PET for subsequent patient management without the data collection burden currently required under the NOPR.

To ensure a smooth transition for CMS, physicians and beneficiaries, we request that the proposed termination dale of NOPR data collection coincide with the effective date of the final National Coverage Determination (NCD).

The one scan limit for subsequent physician management of anti-tumor treatment strategy as proposed is not medically appropriate and could cause significant administrative complications. We request that CMS remove the limitation of one scan and nationally cover FDG PET for subsequent treatment management. In addition to the one scan limit, it is unclear as to which indications this proposed decision applies. We request the proposed decision only apply to those indications that were covered under CED. This decision should not include indications previously covered nationally by CAG-00183R3 (2009).

Based on the clinical outcome data shown in the Comparison of the National Oncologic PET Registry 2006-2009 Cohorts, FDG PET was found to be superior in predicting early response to therapy and led to a change in intended management in 35%-40% of cases, with a switch from treatment to non-treatment being three-fold more likely.² Physicians use FDG PET to manage patients and patients react differently to treatment regimen. Without the availability of FDG PET, patients could undergo ineffective costly treatments and physicians may be pressured to make uninformed decisions as to patient management.

From an administrative perspective, requiring local Medicare Administrative Contractors (MACs) to process additional scan requests could potentially create significant administrative complications and inconsistencies between local MACs. There are many cases, as proven by clinical evidence, where more than one scan for subsequent treatment management is clinically necessary. Finalizing a national one scan limit would prompt physicians to send multiple requests for additional scans, which will lead to delays in approvals, delays in treatment and delays in reimbursement for beneficiaries.

Based on current peer-reviewed published articles, FDG PET is clinically valuable when accessing and managing metastatic castrate-resistant prostate cancer.³ Therefore, we strongly urge CMS to include the use of FDG PET for castrate-resistant metastatic prostate cancer.

In conclusion, we appreciate the opportunity to comment and thank CMS for considering the above stated points. We support the proposal to end the CED data collection for the use of FDG PET. The data demonstratep that FDG PET is clinically valuable in guiding the treatment management of Medicare beneficiaries. We therefore request national coverage and payment of FDG PET for subsequent treatment management without the one scan limitation.

Sincerely,

Dr. Christoph Zindel
Chief Executive Officer
Siemens PETN ET Solutions

Alexander R. Zimmermann
Vice President, Sales & Marketing
Molecular Imaging Siemens Healthcare

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I am a radiologist specialized in nuclear radiology. I have been interpreting PET and PET/CT scans for the past 13 years, and I strongly oppose the proposed CMS limitation of one PET/CT for restaging of cancer patients. This limitation would seriously compromise the care of millions of MEdicare cencer patients who rely on PET/CT for early detection of their suspected recurrent disease. This proposal will handcuff the medical oncologists and radiation oncologists who increasingly rely on PET/CT as the modality of choice for restaging of their patients after treatment. It is not uncommon for us to encounter patients who have abnormal tumor marker levels but negative conventional imaging studies. In those particular patients PET/CT affords the greatest opportunity to detect early disease recurrence. If the physicians caring for these patients were limited in ordering a PET/CT due to the proposed CMS limitations, these patients may have their recurrent disease undetected until such time that treatments would be less effective.

I urge CMS to reconsider the proposal for limiting PET/CT scans in restaging and treatment monitoring of Medicare patients.

Sincerely,

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I appreciate the opportunity the comment regarding the utilization of PET scans for solid tumors. As a practicing medical oncologist, I am responsible for evidence-based, rational and cost-effective choices in diagnostic testing and therapy choices. This is an imperative of good medicine and of our health care system dollars.

PET scan is an very important tool in our oncology management and is used to determine important decisions- not only staging to drive initial therapy decisions, but if appropriate response to therapy in a timely way that does not extend ineffective therapy. There are also circumstances where PET scan is the best means of evaluating an abnormality on other imaging (typically CT) in order to guide whether we need to biopsy or change course.

The biggest concern with the proposal is the limit to 2 PET scans in the lifetime course of a patient with a solid tumor. Although this may well reflect the needs in many such patients, there are appropriate uses as mentioned that would not be rare in the course of care. These remain evidence-based and best test to arrive at the infomration needed for decision-making.

Obviously indiscriminate overutilization would appear to be underlying this policy propsoal (?). If this relates to assessing treatment response, that is true that PET is not the tool for such in solid tumors in general, as opposed to hematologic malignancies like lymphomas. There may be exceptional cases where the location of metastatic disease is not well measured by other means, but this is the exception. The other indications for PET scanning remain valid and valuable in appropriate and cost effective decision-making.

We are in the age of appropriate evidence-based guidelines, including for diagnostic testing, and these should guide utilization and appropriate reimbursement.

Although this proposal allows request for individual scans from the local CMS carrier, this extra demand will add to the ever increasing burden on oncololgy and medical practice that ultimately cumulatively will undermine quality care, for providers and most importanlty the Medicare patient population. And CMS policy drives the direction of other insurers- so it is critical that utilization and reimbursement decisions be approporiate and importantly proportional to the rational and evidence-based utilization and hold us responsible for that. The pressures on our practices are increasing from all directions and there are very real and increasing consequences that will threaten what is high quality community based oncology care- that care which provides the majority of cancer care for Americans.

Thank you for your attention to these concenrs.

Ira Zackon, M.D.
Heatologist/Medical Oncologist
New York Oncology Hematology
Albany, New York

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. I would like to express my strong agreement with the comments submitted by the Joint-Society letter from the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS).

I would like to state my opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. We are shocked that CMS proposes the extraordinary step of reversing coverage for post-treatment evaluations that has been in place for the majority of Medicare’s cancer patients for years. This proposal represents an inestimable setback in the ability to optimize treatment for millions of cancer patients. We strongly urge that CMS reconsider this portion of its proposal, and remove this restriction from its final decision on the initial request. Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. For many patients, it is the single most important diagnostic modality in managing their treatment. To remove this critical tool from the cancer specialists' armamentarium would have an adverse effect on the care of millions of Medicare beneficiaries. While it is true that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, there a number of better mechanisms to address over-utilization without such draconian measures and without grave consequences for patients who legitimately require FDG-PET imaging for their care.

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully

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To whom it may concern,

I am writing this letter in regard to recent upcoming decisions regarding CMS coverage for PET scans. It is certainly encouraging that recently PET has been approved for more diagnoses including pancreas cancer, small cell lung cancer and testicular cancer. These are very metabolically active malignancies and the PET scan is a valuable adjunct in management of these tumors.

However the recent proposals to limit coverage of PET scans that are obtained per patient will significantly interfere with the clinical decision-making in these patients. As a practicing oncologist for over 20 years the PET has proved invaluable in the followup of residual masses after treatment of lymphomas as well as other malignancies. As an example the data is strong data that a negative PET scan is associated with prolonged disease-free survival in lymphoma. We are able to avoid biopsy of multiple masses in patients after treatment. Other imaging modalities can be limited apart from seeing growth in the mass suggesting a change in the tumor.

Additional invasive biopsies will be needed to distinguish residual fibrosis versus an active tumor. In addition multiple more CAT scans and MRIs would likely be needed to help decide whether treatment regimens are active or failing in patients. This will certainly affect the clinical care of patients with multiple types of malignancies. Treatment decisions may be delayed and ineffective treatments may be given longer than necessary. Certainly with the cost of many of the chemotherapeutic drugs in this day and age it will not only add potential toxicity for the patient but significant cost if an ineffective regimen is continued beyond its usefulness. Since currently most malignancies have multiple chemotherapeutic regimens which they are sensitive to and which can cure or prolong survival a prompt change in treatment is often to the patient's benefit both in longevity and in avoiding unnecessary toxicity with continuing an ineffective treatment.

Limiting the number of PET scans per patient or per diagnosis is therefore a poor decision and is not necessarily cost-effective. It has been a significant help in deciding whether a treatment regimen is effective in a particular disease. Although a PET scan may not always be needed to make these decisions there are many times when the added information that provides is invaluable. Any consideration you could give to these comments would be greatly appreciated.

Sincerely,

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Hello,

I have been happy to be a part of NOPR from the beginning and thank you for extending coverage for specific tumors. I believe all of us see the impact of detecting the extent of disease on the initial scan to assist decisions by the oncologists for patient therapy. Subsequent PET scans also contribute to the patient’s well being along with contributing to cost saving decisions.

I am surprised to see the CMS propose to limit the number of PET scans after seeing the data reflect the physician is influenced to continue, switch, adjust, or stop chemotherapy on about 40% of the patients. In the big picture I believe the cost savings is not repeating a chemotherapy agent that was ineffective or not continuing chemotherapy after a complete response.

Thank you for your efforts.

Regards

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. In general, I would like to express my strong agreement with the comments submitted by others, specifically the Joint-Society letter from the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). I would also would like to express my vigorous support for the comments and data submitted by the National Oncologic PET Registry (NOPR) Working Group.

I applaud CMS’ proposal to end Coverage with Evidence Development (CED) data collection for the use of FDG-PET for oncologic indications. I strongly agree with the original requestors that sufficient evidence has accrued regarding the substantial benefit in management of patients afflicted by cancer to lift the previous CED requirements.

However, I am surprised and dismayed by several of the components of the recent proposed decision memorandum.

First, I believe that CMS should reverse the proposed non-coverage of prostate carcinoma. While most prostate carcinomas show limited FDG avidity, there are certain subpopulations of prostate cancer patients who have benefitted from, and should be permitted to continue to benefit from, FDG-PET. In particular, FDG-PET has shown substantial utility in patients with castrate-resistant prostate cancer.

Most importantly, I would like to voice my strongest possible opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. We are shocked that CMS proposes the extraordinary step of reversing coverage for post-treatment evaluations that has been in place for the majority of Medicare’s cancer patients for years. This proposal represents an inestimable setback in the ability to optimize treatment for millions of cancer patients. We strongly urge that CMS reconsider this portion of its proposal, and remove this restriction from its final decision on the initial request. Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. For many patients, it is the single most important diagnostic modality in managing their treatment. To remove this critical tool from the cancer specialists' armamentarium would have an adverse effect on the care of millions of Medicare beneficiaries. While it is true that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, there a number of better mechanisms to address over-utilization without such draconian measures and without grave consequences for patients who legitimately require FDG-PET imaging for their care.

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully submitted,

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Curtail PET imaging is poor public policy because in runs opposite to medical progress.

PET imaging is becoming a key component of getting cancer patients to the cure.

Getting patients to the cure, in head and neck cancer, for example, is imaging before and early in treatment to predict if the course of treatment will lead to a cure or second line more aggressive treatment to be tried earlier.

Medical research is showing this approach will lead to more cures in many cancers.

Specifically,
1. CMS should reverse the proposed non-coverage of prostate carcinoma.

2. CMS should not implement the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan.

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Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

RE: Comment on Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Dear Dr. Jacques:

At Emory University and Winship Cancer Institute, we are in favor of the general concept of eliminating prospective data collection as a condition of FDG-PET scan approval for those studies currently included under Coverage with Evidence Development (CED).

Yet, we are troubled that the proposed guidelines would seem to restrict the use of oncologic FDG-PET for subsequent patient management to coverage of a single lifetime scan. This national determination, leaving additional scans only to be covered at the discretion of local Medicare Administrative Contractors would, in effect, impose an arbitrary blanket limitation on FDG-PET and would not encourage best clinical practices individualized and personalized for every patient.

Most importantly, this rule would seem to include those patients who have been previously treated for cancer, yet now have either proven or strongly suspected recurrence. There is a wealth of literature establishing an important role for FDG-PET in these clinical circumstances. As the only NCI-designated Cancer Center in Georgia, we commonly see patients where no other imaging has been able to pinpoint the suspected recurrent disease, yet FDG-PET is successful in this regard. This has resulted in more accurately restaging the patient, enabling the most appropriate care or even a durable cure in cases of treatable oligometastasis. We have observed that recurrent cancer is often more aggressive, which makes FDG-PET especially useful in these circumstances. We believe it would be a mistake to allow this use of FDG-PET on a case by case basis only, since the data reinforced by our experience has been so compelling.

While we join CMS and other organizations in the concern about the overuse of imaging for asymptomatic surveillance after cancer therapy, we believe that the current proposal is over-reaching and will lead to disparate local coverage standards and a reduction in the fine care that we are able to provide our cancer patients. We urge CMS to propose guidelines without such blanket limitations and which will be in line with those of major radiology benefits management organizations such as AIM Specialty Health, whereby a patient with recurrent disease has the “clock reset” in terms of their ability to undergo of FDG-PET. Thus, a recurrence is essentially treated as a new cancer allowing the patient to undergo additional FDG-PET studies, leading to more accurate re-staging.

Instead of the present language, we urge CMS to employ a targeted statement directed against the use of FDG-PET for asymptomatic surveillance in patients who are greater than 1 year distant from a complete response.

Respectfully submitted,

David M Schuster, MD
Associate Professor
Director, Division of Nuclear Medicine and Molecular Imaging
Department of Radiology and Imaging Sciences
Emory University

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors.

First, I would like to express my strong agreement with the comments submitted by others, specifically the Joint-Society letter from the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). I would also would like to express strong support for the data submitted by the National Oncologic PET Registry (NOPR) Working Group.

I strongly agree with the original requestors that adequate evidence has accrued regarding the significant benefit in management of patients afflicted by cancer to lift the previous CED requirements.

However, I strongly disagree with several of the components of the recent proposed decision memorandum.

I believe that CMS should reverse the proposed non-coverage of prostate carcinoma. While many prostate carcinomas show limited FDG avidity, there are certain subpopulations of prostate cancer patients who have benefitted from, and should be permitted to continue to benefit from, FDG-PET. In particular, FDG-PET has shown substantial utility in patients with castrate-resistant prostate cancer. In my practice, we interpret PET examinations for prostate cancer not infrequently. There are many occasions where FDG-PET is helpful for both staging and subsequent treatment planning purposes. Prostate cancer is also often detected incidentally in patients undergoing PET examinations for another malignancy.

More importantly, I would like to voice my strong opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. In our practice, the results of serial PET scans are used to guide and alter treatment regimens in the majority patients. A single post-treatment PET examination may indicate that a patient is not responding to therapy. What is the next step after a new therapy regimen to evaluate for treatment response? Anatomic imaging only provides information on tumor size. Often the tumor will be stable in size, but demonstrate resolution of FDG accumulation consistent with treatment response or increasing hypermetabolism indicating progression. FDG PET is an invaluable tool in the oncology arsenal, and is often the single most important diagnostic modality in managing their treatment. It can demonstrate local recurrence or metastatic disease in high risk patients long before CT or MRI demonstrates measurable change in size. As a radiologist that interprets both body CT and PETCT on a routine basis, the value of PETCT in determining the response to therapy is blatantly apparent.

Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. While I completely agree that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, I also believe that there a number of better mechanisms to address over-utilization without such extreme measures and without grave consequences for patients who legitimately require FDG-PET imaging for the management of their particular disease.

I hope that CMS will view the scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully submitted

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. In general, I would like to express my strong agreement with the comments submitted by others, specifically the Joint-Society letter from the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). I would also would like to express my vigorous support for the comments and data submitted by the National Oncologic PET Registry (NOPR) Working Group.

I applaud CMS’ proposal to end Coverage with Evidence Development (CED) data collection for the use of FDG-PET for oncologic indications. I strongly agree with the original requestors that sufficient evidence has accrued regarding the substantial benefit in management of patients afflicted by cancer to lift the previous CED requirements.

However, I am surprised and dismayed by several of the components of the recent proposed decision memorandum.

First, I believe that CMS should reverse the proposed non-coverage of prostate carcinoma. While most prostate carcinomas show limited FDG avidity, there are certain subpopulations of prostate cancer patients who have benefitted from, and should be permitted to continue to benefit from, FDG-PET. In particular, FDG-PET has shown substantial utility in patients with castrate-resistant prostate cancer.

Most importantly, I would like to voice my strongest possible opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. We are shocked that CMS proposes the extraordinary step of reversing coverage for post-treatment evaluations that has been in place for the majority of Medicare’s cancer patients for years. This proposal represents an inestimable setback in the ability to optimize treatment for millions of cancer patients. We strongly urge that CMS reconsider this portion of its proposal, and remove this restriction from its final decision on the initial request. Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. For many patients, it is the single most important diagnostic modality in managing their treatment. To remove this critical tool from the cancer specialists' armamentarium would have an adverse effect on the care of millions of Medicare beneficiaries. While it is true that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, there a number of better mechanisms to address over-utilization without such draconian measures and without grave consequences for patients who legitimately require FDG-PET imaging for their care.

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

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Regarding the recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors. I would like to express my strong agreement with the comments submitted by others, specifically the Joint-Society letter from the American College of Radiology (ACR), and the American College of Nuclear Medicine (ACNM)

First, I believe that CMS should reverse the proposed non-coverage of prostate carcinoma.

Most importantly, I would like to voice my strongest possible opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan.

I am going to be blunt on this one. This is mind numbingly ignorant.

I am shocked that CMS proposes the extraordinary step of reversing coverage for post-treatment evaluations that has been in place for the majority of Medicare’s cancer patients for years. I strongly urge that CMS reconsider this portion of its proposal, and remove this restriction from its final decision on the initial request.

I am sure that you have heard the following, so please skip it if you have already been educated about the ignorance of the single PET coverage proposal. Needless to say, if this were you or your loved ones, you would be violently opposed to the proposition.

Cancer patients today are living longer and undergoing multiple and novel treatment regimens, requiring multiple imaging studies over the course of their battles with cancer to assess baseline tumor extent, monitor therapeutic efficacy, evaluate eventual response, and assess for clinically suspected recurrence. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. For many patients, it is the single most important diagnostic modality in managing their treatment. To remove this critical tool from the cancer specialists' armamentarium would have an adverse effect on the care of millions of Medicare beneficiaries. While it is true that appropriate utilization should be ensured and that FDG-PET should not be utilized for routine surveillance of asymptomatic patients without clinical suspicion of active tumor, there a number of better mechanisms to address over-utilization without such draconian measures and without grave consequences for patients who legitimately require FDG-PET imaging for their care. Please involve diagnostic imagers/radiologists/nuclear medicine specialists and oncologists in these decisions!!!!

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully submitted,

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A national nonprofit organization dedicated to working together to advance research, support patients, and create hope for those affected by pancreatic cancer, the Pancreatic Cancer Action Network thanks the Centers for Medicare and Medicaid Services for issuing the Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4).

While the precise value of PET scans in the care of people with pancreatic cancer has not been thoroughly elucidated, studies have shown that PET scans have value in determining subsequent treatment strategies, as well as under other circumstances. The Pancreatic Cancer Action Network thus supports the coverage of PET scans for subsequent treatment strategies without the coverage with evidence development requirement.

Thank you very much for posting the Proposed Decision Memo, and if we can be of any assistance, please do not hesitate to contact us.

Sincerely,

Megan Gordon Don
Director, Government Affairs and Advocacy

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum regarding coverage for 18F-fluorodeoxyglucose PET and PET/CT imaging (FDG-PET) in solid tumors.

I would like to voice my strongest opposition to the proposal that FDG-PET coverage for subsequent patient management be limited to a single nationally-covered scan. This proposal represents a tremendous setback in the ability to optimize treatment for millions of cancer patients. FDG-PET has shown unique abilities in treatment monitoring, restaging, and overall subsequent treatment planning and has, therefore, been incorporated into treatment guidelines for many cancers. In patients who have been previously treated, FDG-PET has often found recurrent disease far earlier than conventional CT alone, thereby allowing for far less invasive and costly treatments for patients. Additionally, in patients with lymphoma, FDG-PET will often provide invaluable information regarding residual/recurrent disease. Where CT will often be relatively stable, there may be a clear change in SUV. This critical information allows for alteration in the patient treatment plan. These are just a few examples of how FDG-PET significantly impacts patient care. To remove this critical tool would have an adverse effect on the care of millions of Medicare beneficiaries. I would like to express my strong agreement with the comments submitted by the Joint-Society letter from the ACR, ACNM, ASNR, SNMMI, and WMIS. I would also would like to express my support for the comments and data submitted by the National Oncologic PET Registry (NOPR) Working Group.

I hope that CMS will view the global body of scientific evidence and clinical experience demonstrating the tremendous value of FDG-PET in cancer care, including the extensive data submitted by the NOPR investigators, and will reverse these elements of its recent proposed decision.

Respectfully submitted,

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April 11, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

The Centers for Medicare & Medicaid Services (CMS) has proposed to end the current requirement for prospective data collection by the National Oncologic PET Registry (NOPR) for F-18 fluorodeoxyglucose positron emission tomography (FDG PET) for oncologic indications. For prostate cancer, this decision now proposes to terminate coverage both for baseline imaging and for post-treatment imaging using FDG PET (coverage for baseline imaging having been terminated by the April 2009 NCD). This decision appears to be made despite the fact that the NOPR data suggest that FDG PET findings lead clinicians to modify their clinical management of prostate cancer patients, at a frequency commensurate to other solid tumors.

The NOPR data support that clinicians find FDG PET to be a useful imaging modality for staging and monitoring disease. These data are compelling: 40% of clinicians indicated that they altered treatment as a result of the FDG PET imaging. Although CMS appears to dismiss such findings, we would argue that if anything 40% is a conservative estimation of the true clinical impact that FDG PET could have in the management of this disease.

Specifically, the CMS statement indicates that, “NOPR findings (e.g., Hillner 2012) indicate that in about 40% of instances, physicians would change their intended therapy for patients with prostate cancer, a cancer that according to a prior NOPR-derived publication (Hillner 2009) was thought to be of limited performance for FDG PET/CT due to prostate cancer cells’ lack of glucose avidity.” The assumption that prostate cancer is “thought to be” lacking in glucose avidity is based on a selective interpretation of the literature. Previous analyses examining FDG PET only poorly controlled for a patients’ stage and clinical state, for disease progression (and therefore glucose metabolic activity), and had poorly defined endpoints. As we have summarized elsewhere, these studies then erroneously concluded that tracer uptake was inadequate rather than the studies’ design and plan.¹ In detail, the methodologic issues as they apply to FDG PET in prostate cancer are:

• FDG uptake is contingent on glucose metabolism, which appears to decline significantly when patients are responding to therapy.² It is important, then, that any analysis of FDG PET for staging, prognostication, or initiating therapy document that the patient has progressive disease whether that patient is on or off treatment.


• When studying FDG PET, it is critical that the study question match both the study population and the endpoint. Mismatches of the question, the population, and the endpoint have long plagued prostate cancer biomarker and therapeutic trials. For this reason, the prostate cancer clinical trials community has ensured consistency of these three components by agreeing upon a clinical states model that describes the disease spectrum, and has developed consensus criteria for trial designs applied to each state.^3-5 These criteria ensure, for example, that the question of response is not applied to the Rising PSA population after radical prostatectomy when no radiographic evidence of disease is detectable. For that population, the relevance of the question is disease detection. By the same token, it ensures that the question of disease detection is not asked in the context of established metastatic disease. For that population, the question is prognostication, demonstration of drug effect, or correlation with clinical outcome.

The NOPR data indicate that FDG PET resulted in a change in management in 40% of cases. Clinicians therefore found it to be a useful imaging modality for informing treatment decisions. However, NOPR did not control for disease progression, and therefore some FDG scans might have been negative if the patient was responding to treatment at the time of imaging. NOPR did not control for clinical state, and therefore it is possible that the questionnaire questions were mismatched for the rationale of performance of the study. Hence, although the NOPR data are compelling at face value to warrant continued CMS reimbursement for FDG PET, the NOPR data might well be a very conservative estimate of the value of FDG PET in this disease.

To support this conclusion, we wish to bring to CMS’ attention peer reviewed and published data, which were not included in the CMS summary document. It is important to note that these studies comply with the review standards established by CMS for inclusion in analysis. In these additional published studies, patients were prospectively imaged, controlled for progression, using a fixed interval of scan performance, and occupying a similar clinical state:

Disease Detection (i.e., detection of skeletal metastases): In an analysis of 43 patients with metastatic castration-resistant prostate cancer (CRPC), 1720 bones were examined by bone scintigraphy and compared with PET findings. Of these, 1079 were negative on both modalities, and 400 were positive on both. Of the 121 mismatches where FDG PET was positive but bone scans were negative, follow-up bone scans on 84 were positive, suggesting that PET was superior in terms of detecting early metastatic disease. In total, these data represent a 90% concordance rate.^6,7

Demonstration of treatment effects: We studied FDG PET prospectively and compared it with post-treatment alterations in PSA and standard imaging. FDG PET captured in a single imaging modality the information usually captured in the standard composite clinical endpoint of PSA, bone scintigraphy, and soft tissue imaging. We examined 22 patients with metastatic CRPC who were registered to clinical trials utilizing anti-microtubule chemotherapy (such as paclitaxel, docetaxel, or epothilone-based therapy). These patients were co-registered to our imaging study comparing changes in FDG uptake (SUV), PSA, and standard imaging. These patients were followed to progression or death. SUV and PSA were treated identically using a modified form of the PSA Working Group criteria,⁸ and the data were dichotomized into categories of either progressing or not-progressing with treatment. After four weeks of chemotherapy, PET and PSA were in agreement in 86% of cases; in 91% of cases, however, FDG PET correctly identified whether the patient was progressing. After 12 weeks of therapy, PET, PSA, and standard imaging were compared. In 94% of cases, PET correctly identified the correct clinical status of the patients. These data warrant validation in a larger data set, but do suggest that FDG PET, when studied prospectively in a population rigorously controlled for clinical state and disease progression, can effectively be used to demonstrate treatment effects.⁹

FDG PET to assess prognosis: Ninety-six MSKCC patients with metastatic CRPC were prospectively scanned serially using FDG PET, controlling for disease progression, clinical state, scanning algorithm, and method of interpretation. At a median follow-up of 19 months, and median survival of 20 months, in the multivariate analysis, only LDH and FDG PET standardized uptake value (SUV)maxavg were significantly associated with overall survival.¹⁰ This database has also furnished preliminary prognostic information regarding the value of FDG PET. These data verify our earlier analysis of FDG PET as a prognosticator in metastatic CRPC.⁶

We therefore strongly urge CMS to reconsider its decision to withdraw support of FDG PET in prostate cancer. Prostate cancer is the most commonly diagnosed non-dermatologic cancer in the US, and the second leading cause of cancer-related death in American men.¹¹ The majority of these men will die of metastatic disease to bone, for which there is no standard imaging modality that can directly image the cancer that is accurate or reliable. As a result, prostate cancer clinicians have no imaging modality to accurately portray disease extent, to determine prognosis, or to assess response to therapy.¹² In the proposed decision, CMS suggests that C-11 choline may be of greater interest to the prostate cancer community than FDG. At present, however, the Mayo Clinic is the only institution for whom an NDA has been granted for C-11 choline, and so that radiopharmaceutical is only available to patients studied at that institution in Rochester, Minnesota. While we applaud the initiative of Mayo Clinic, we point out that no judgment at all has been rendered as far, as we are aware, regarding CMS coverage of PET with C-11 choline for Medicare beneficiaries with prostate cancer. But clearly, when and if C-11 choline is found reasonable and necessary, since the half-life of C-11 is only 20 minutes, availability will be limited to institutions with rapid access to a GMP radiopharmacy and cyclotron. Also, in order to make C-11 choline widely available to Medicare patients, many institution or radiopharmacies will need to file their own ANDAs for C-11 choline. The regulatory process to achieve this is both costly and time consuming.

NOPR found that this medical need in prostate cancer could, in part, be satisfied by FDG PET imaging, which was being used selectively in the large population of patients with prostate cancer in the US. Our own studies support this conclusion, as we found that FDG PET has a 90% concordance with standard imaging for bone metastases, correctly identifies responders and progressors in 94% of cases as a response indicator biomarker, and is a powerful prognostic biomarker. Given the lack of an imaging biomarker in prostate cancer, staging and assessing treatment response is exceedingly poor at all phases of this disease. There is no other disease where development of an effective imaging biomarker could impact so many cancer patients who risk dying of disease. CMS should consider this singular disparity and medical need before terminating support for FDG PET in prostate cancer.

In this letter we have presented research data in support of a major clinical benefit of FDG in advanced prostate cancer patents. CMS is clearly aware that, for the reasons stated in the proposed decision, FDG has already been approved by the FDA for tumors that metabolize glucose and that high quality FDG, is available everywhere in the US, including Alaska and Hawaii, for access by Medicare beneficiaries. For these reasons, as a consortium of academic centers united for the study of prostate cancer, we respectfully request that the additional data we have provided, on the role of FDG in prostate cancer, be used by CMS as a basis to reconsider the proposed decision that PET FDG use in prostate cancer is not reasonable or necessary.

Sincerely,

Michael J. Morris, MD
Prostate Section Chief
Memorial Sloan-Kettering Cancer Center
Co-PI, Coordinating Center, Prostate Cancer Clinical Trials Consortium

Howard I. Scher, MD
Chief, Genitourinary Oncology Service
Memorial Sloan-Kettering Cancer Center
PI, Coordinating Center, Prostate Cancer Clinical Trials Consortium

Steve Larson, MD
Vice Chair for Research, Department of Radiology
Memorial Sloan-Kettering Cancer Center

Emmanuel S Antonarakis, MD
Assistant Professor of Oncology
Johns Hopkins, Sidney Kimmel Comprehensive Cancer Center

Tomasz M. Beer, MD
Deputy Director, OHSU Knight Cancer Institute

Michael A. Carducci, MD, FACP
AEGON Professor in Prostate Cancer Research
Professor of Oncology and Urology
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Elisabeth I. Heath, MD, FACP
Director, Prostate Cancer Research
Karmanos Cancer Institute, Wayne State University
Celestia S. Higano, MD, FACP
Professor, Departments of Medicine and Urology
University of Washington
Member, Fred Hutchinson Cancer Research Center
Seattle Cancer Care Alliance

Maha Hussain, MD, FACP
Professor of Medicine and Urology
Associate Director for Clinical Research
Co-Leader, Prostate Cancer Program
University of Michigan Comprehensive Cancer Center
Associate Chief for Clinical Research
Division of Hematology/Oncology, Department of Internal Medicine

Glenn Liu, MD
Leader, Genitourinary Oncology Disease-Oriented Working Group
Director, GU Oncology Research and Cancer Therapy Discovery and Development Programs
University of Wisconsin Carbone Cancer Center

Christopher J. Logothetis, MD
Chair, Department of Genitourinary Medical Oncology
The University of Texas MD Anderson Cancer Center

Barry A. Siegel, MD
Chief, Division of Nuclear Medicine
Mallinckrodt Institute of Radiology
Washington University in St. Louis School of Medicine

Eric J. Small, MD
Chief, Department of Medicine/Division of Hematology/Oncology, UCSF
Deputy Director and Associate Director, Clinical Sciences, UCSF Helen Diller Family Comprehensive Cancer Center

Walter Stadler, MD, FACP
Fred C. Buffett Professor of Medicine & Surgery
Interim Section Chief
Sections of Hematology/Oncology
University of Chicago

Mark Stein, MD
Assistant Professor of Medicine
The Cancer Institute of New Jersey
University Of Medicine and Dentistry of New Jersey

Wolfgang A. Weber, MD
Chief, Molecular Imaging and Therapy Service
Director, Laurent and Alberta Gerschel Positron Emission Tomography Center
Memorial Sloan-Kettering Cancer Center

cc: Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group, CMS
James Rollins, MD, PhD; Director, Division of Items and Devices, CMS
Stuart Caplan, RN, MAS, Lead Analyst, CMS
Jeffrey C. Roche, MD, MPH, Medical Officer, CMS

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CMS attention to this issue is welcome. NOPR has clearly served its purpose and has demonstrated quite well that FDG PET imaging is quite useful in the management of most solid tumors. The one scan restriction for subsequent treatment strategy is however rather limiting as it will allow for only one FDG PET scan for restaging, detecting recurring, assessing response, and surveillance purposes. This has potential to significantly affect patient care and will also affect the current established practice in oncology for several malignancies. The NOPR data clearly shows the benefits of FDG PET imaging universally in almost all malignancies and although there are certain limitations in particular instances (like low volume or low grade disease or malignancies with low FDG avidity), such a blanket restriction goes against the principles of good clinical practice as well as accepted data from NOPR and other studies pertaining to PET.

There are multiple instances when FDG PET is required more than once in the subsequent treatment strategy setting. Lymphoma, colorectal and lung malignancies are a few examples. Frequently, residual disease is detected or suspected on FDG PET after treatment and when confirmed, it would logical as well as good clinical practice to use the same modality to follow the disease after additional treatment.

There is certainly potential for overuse of FDG PET especially for surveillance purposes. But there are other ways to control this rather than a blanket restriction especially since it also proposes to roll back established coverage for many malignancies that are currently covered by CMS without any such restriction for subsequent treatment strategy. A few approaches towards this would be establish frequency limits for subsequent treatment strategy scans or establish guidelines that require clinicians to justify the scan based on clinical suspicion for recurrence rather than get the scan for just routine surveillance.

In its current format, the proposed changes to reimbursement will significantly affect clinical care of cancer patients especially the way they are managed and followed.

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I would like to first thank CMS for broadening the scope of cancers covered for FDG PET scans, which has vastly improved the detection and subsequent treatment of many cancer sites in the radiation therapy side of cancer treatment. Unfortunately, limiting patients to two lifetime PET scans would greatly impact cancer care in a very detrimental way.

For instance, take hypothetical patient A. Patient A is suspected of having a lung cancer, and on CT scan it looks quite small, but on PET scan it is determined that it is not only larger than the CT showed, there is further disease missed on CT. The patient receives chemotherapy and then receives a follow up PET. This scan shows that much of the cancer has shrunken, but the primary tumor is still active and in need of Radiation Therapy. For a variety of reasons, if this is the last PET scan allowed, the impact of this very arbitrary and negative policy could be felt in several ways. If the provider, in this instance the VA, takes an extremely long time to work the patient through an overly cumbersome system and several months go by with no start of Radiation since the most recent PET, the cancer will indeed grow beyond the scope of the last known PET making treatment planning less effective and accurate at best, inadequate at worst. In Radiation Therapy we endeavor to deliver the most accurate radiation volume possible. Without the most up to date PET scan, this accuracy is greatly decreased. I have personally seen this happen when PET is unavailable at the time of treatment planning.

Let’s assume another scenario, where patient A somehow miraculously receives his deeply rationed limit of PET scans, and the most recent is used for a very accurate Radiation Therapy treatment plan. 6 moths later, follow up CT scan shows what may be scarring from a high radiation dose, but a subsequent PET scan would show metabolic activity which can be differentiated from scarring and indicate the need for follow up chemotherapy.

Additionally, without PET, there would be a dramatic increase in additional studies which would drive up costs, and more invasive procedures would also increase costs and negatively impact this patient population. Many of these studies and procedures are deemed inappropriate when PET is available to most accurately evaluate the disease process. In the days before PET, many recurrent cancers went undetected and were not diagnosed until after effective treatment would be appropriate.

These are just a couple of the potential downsides to this possible CMS determination. PET has vastly increased the detection and subsequent treatment of many tumor types, and rationing this care would be a disservice to both patients and the caregivers doing their best to deliver the highest quality cancer care possible. This also is another step down the road that many alarmists on the right quickly point to when the specter of government run healthcare looms before them. Rationing care to our seniors is not helpful, to those very seniors or to the advancement of cancer care in America. I personally would rather see a decrease in payment for PET scans rather than an outright rationing of care. Decreased payments already stress Community Cancer Centers across America, but rationing would be far worse!

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April 11, 2013

Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, Maryland 21244

Attention: Louis Jacques, MD (Director); Tamara Syrek-Jensen, JD (Deputy Director); James Rollins, MD, PhD (Director, Division of Items and Services); Stuart Caplan, RN, MAS (Lead Analyst); Jeffrey C. Roche, MD, MPH (Medical Officer)

Dear Dr. Jacques et al.,

The Medical Imaging & Technology Alliance (MITA) appreciates this opportunity to respond to the Centers for Medicare and Medicaid Services’ (CMS’) request for comments on the proposed decision memorandum for the use of FDG with positron emission tomography (PET-FDG) at Section 220.6 of the Medicare Coverage Manual. As the leading trade association representing medical imaging, radiotherapy technology, and radiopharmaceutical manufacturers, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging and radiotherapy provide. MITA is pleased to work with CMS to ensure Medicare beneficiaries have proper access to these life-saving technologies. We appreciate CMS’ steps forward in considering the National Oncological PET Registry’s (NOPR’s) reconsideration request to end the Coverage with Evidence Development (CED) requirement for FDG-PET in subsequent treatment planning.

After careful review of the proposed decision memo, MITA offers these comments with the ultimate objective of ensuring that this important, clinically meaningful technology is utilized appropriately and without hindering treating physicians’ ability to make sound medical decisions. We will focus our comments on the following topics:

• Lifting CED requirements and thus ending NOPR’s data collection process for FDG
• Limiting the frequency of FDG-PET scans for subsequent treatment planning to one
• Prohibiting the use of FDG-PET for subsequent treatment planning in prostate cancer patients

Lifting CED Requirements
MITA is pleased that CMS has proposed lifting the CED requirements for subsequent treatment planning with FDG-PET and to grant full coverage. The wealth of data that NOPR provided through the CED process demonstrates the value and effectiveness of this diagnostic modality. As NOPR stated in its national coverage determination request, treating physicians changed their intended treatment plans in more than one third of encounters.¹ We are grateful to CMS for proposing that Medicare beneficiaries with cancer can now be diagnosed without the additional administrative burden on the health care providers involved in their treatment and/or care.

Limiting Scans in Subsequent Treatment Planning
We are concerned that limiting FDG-PET scans to one for initial treatment strategy, as CMS has done in the Medicare Coverage Manual based on NOPR’s previous coverage request², applies to subsequent treatment planning. Subsequent treatment strategy will naturally encompass more than one decision point as survival rates improve. As NOPR stated in its comment to the reconsideration request, based on the analysis comparing the 2006 and 2009 cohorts, FDG-PET “was associated with about a 35% change in intended management.”³ This significant decision support resource should not be limited to one scan when over one-third of patients may benefit from a change in the way they receive treatment for oncologic conditions. We understand CMS’ concern that additional subsequent treatment planning scans beyond one could cause a strain on resources; however, we believe that just as with the NOPR process, these additional scans would be limited and only provided to targeted segments of the population where therapy has not seemed to work, or there is suspicion of cancer recurrence.

In CMS’ own analysis, as described in the proposed decision memo, the findings of prospective cohort studies indicated “FDG-PET was found to be superior in predicting early response to therapy,”⁴ “FDG PET results change intended management for a variety of common cancer types,”⁵ and in a case report, “FDG PET was useful to demonstrate treatment response to imatinib even in cases in which CT measurements did not show changes in tumor volume or density.”⁶ Thus, evidence supports utilization as necessary of FDG-PET in subsequent treatment planning; however, we are in full agreement with CMS – and the NOPR – that this subsequent treatment planning utilizing more than one scan does not equate to surveillance.

On the administrative and process side, MITA is concerned that permitting the Medicare Administrative Contractors (MACs) to make local determinations on whether additional scans should be permitted will result in inconsistent local policies. Though we requested local contractor decisions for future FDA approved tracers, we are concerned that without explicit instructions as traditionally have been provided with the use of FDG-PET, Medicare beneficiaries may have inconsistent access to the modality. To resolve these issues, MITA supports NOPR’s original request for full national coverage of FDG-PET in subsequent treatment management utilizing the existing framework for the currently covered indications such as lung, colorectal or ovarian cancers.⁷ We ask that the final decision memorandum allow such coverage to ensure that Medicare beneficiaries receive the most appropriate level of treatment based on informed planning decisions.

We also request that CMS clarify the meaning of “initial anticancer therapy” in the proposed decision. Paragraph B of Section I of the proposed decision states, one FDG-PET scan is covered “when used to guide subsequent physician management of anti-tumor treatment strategy after completion of initial anticancer therapy.”⁸ MITA interprets this phrase to mean that treatment monitoring during initial anticancer treatment (i.e., anticancer chemotherapy and/or radiation therapy) would continue to have coverage under §1862(A)(1)(a). The scan permitted by this proposed decision memorandum would apply to subsequent treatment planning only.

We also ask CMS to resolve the administrative issue of a gap in coverage between the implementation of a final decision memorandum and the real-time commencement of MAC activities. We ask that this ambiguous coverage gap be defined in the final decision memo.

Prohibiting FDG-PET in Prostate Cancer
It is widely accepted that FDG is not avid to prostate cancer detection, and would not be an appropriate indicator of disease in initial treatment planning, which is reflected in the non-coverage policy for initial treatment planning. However, strong evidence supports the clinical utility of FDG-PET in patients with advanced castrate-resistant prostate cancer.⁹ Therefore, we request CMS reconsider its outright restriction of utilization of FDG-PET in prostate cancer and allow its use for this specific segment of the prostate cancer population.

Administrative Clarification
As with CMS’ final decision on MITA’s request for reconsideration of national non-coverage for PET¹⁰, we anticipate that CMS will include PET/CT and PET/MRI in the final decision for this request. If CMS decides that the hybrid modalities should not be included in the final decision memorandum, we request that the agency specifically state the type(s) of modalities to be considered in the decision.

We commend CMS for utilizing the decision criteria in this proposed decision memo, distinguishing diagnostic benefits from therapeutic ones. We encourage CMS to continue using this reasoning for all current and future diagnostic imaging coverage analyses. As always, MITA appreciates the difficult decision process CMS must undertake for each request. We are steadfast in our commitment to work with CMS to ensure the optimal level of coverage of PET procedures for Medicare beneficiaries. Please contact Brian Abraham, Sr. Policy Director, at babraham@medicalimaging.org or (703) 841-3258 with any questions.

Sincerely,

Gail M. Rodriguez, PhD
Executive Director, MITA
Vice President, NEMA

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Comment:
We are submitting this letter in response to the Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4). CMS is proposing to remove the current requirement for prospective data collection by the National Oncologic PET Registry (NOPR), allow only one FDG-PET scan to be covered to help guide subsequent physician management of anti-tumor treatment strategy after completion of initial anti-cancer therapy (coverage of additional PET/FDG scans will be determined by local Medicare Administrative Contractors), and to make PET/FDG scans in patients with prostate cancer nationally non-covered by Medicare. This letter will address these points.

We are the 3 Nuclear Medicine faculty in the Department of Radiology who read all the PET scans at the University of Wisconsin School of Medicine and Public Health, with a combined total of over 65 years as faculty members at this University. We interpret PET scans for patients of the internationally recognized University of Wisconsin Carbone Cancer Center, which serves patients with cancer from areas throughout the State of Wisconsin and is a national leader in cancer therapy. We are pleased to have this chance to respond to the proposed decision.

We would first like to state that we are in support of the letter submitted to CMS from the American College of Radiology (ACR), American College of Nuclear Medicine (ACNM), American Society of Neuroradiology (ASNR), Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS). These groups represent a tremendous amount of clinical and research expertise, and their letter appropriately states the negative impact parts of the proposed CMS decision will have on patients with cancer.

We agree with the CMS proposed decision to end the evidence of coverage development (CED) requirement for FDG PET scanning for oncologic indications, thereby removing the current requirement for prospective data collection by the National Oncologic PET Registry (NOPR). However, we do not agree with the proposed decision to make FDG PET scans in patients with prostate cancer non-covered by Medicare. In subgroups of patients with prostate cancer, those with advanced castrate-resistant disease, PET FDG can be extremely helpful in determining the effectiveness of therapy. While it is true that there is considerable interest in using C-11-choline PET in these patients, most PET centers serving Medicare beneficiaries do not have access to this radiopharmaceutical. Therefore, placing FDG PET in the non-covered category would have a significant negative impact on these Medicare beneficiaries.

We strongly disagree with the proposed decision to allow only one FDG-PET scan to be covered to help guide subsequent physician management of anti-tumor treatment strategy after completion of initial anti-cancer therapy (coverage of additional PET/FDG scans will be determined by local Medicare Administrative Contractors). In many cases, the PET FDG scan is the only way to determine if the cancer has recurred and if the therapy needs to be changed. If only one follow-up PET FDG scan is allowed, than future treatments will be used without having the benefit of the PET FDG scan to determine if the treatments are working, thus leading to unnecessary toxicity to the patient from the therapy if the treatment is not effective. We recommend that CMS cover PET FDG scans for the various oncologic indications without a restriction on the frequency of scans, and allow the local contractors the ability to establish limitations of the number of PET FDG scans allowed as determined to be medically necessary, as is currently within their authority. We do agree with the opinion that PET FDG scans should not be performed for surveillance purposes patients with a low risk of recurrence of their disease.

We appreciate the opportunity to respond to the CMS proposed decision memo, and we hope the proposed changes can be changed for the benefit of Medicare beneficiaries with cancer.

Scott B Perlman, M.D., M.S.
Professor of Radiology
Chief of UW Nuclear Medicine
Director of the UW PET Imaging Center

Michael A Wilson, M.D.
Professor of Radiology

Lance T Hall, M.D.
Assistant Professor of Radiology

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Dear sir or madam,

This is in response to the CMS plans to limit the number of PET scans for cancer patients. As you know, PET scans have become a vital imaging study in the management of cancer patients and we are all very appreciative of its increased coverage allowed by CMS over the years. We also see its potential for misuse and abuse so we understand why CMS would want to limit its coverage.

Still, I would respectfully submit that a limitation in the number of scans per patient per lifetime may not be the best way to approach this. Cancer treatment has improved survival of patients significantly, thus increasing the time over which possible relapses can happen. There may be patients that will never need one but others may require several during their treatment and afterwards. One of my patients, for example, developed a new cancer of the breast while being evaluated for a possible recurrence of her first one. It was a PET that identified the tumor and prevented the need for chemo, not to mention possibly saving her life.

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April 12, 2013

TO: Secretary Sebelius
RE: NCD for Positron Emission Tomography (FDG) for Solid Tumors
FROM: Michael Quinn, M.D., on behalf of the CDI Medical Directors Council

I am responding to your request for comments regarding the recent NCD proposal for FDG-PET imaging. My response is on behalf of the CDI Medical Directors Council, representing over 300 radiologists in 25 states.
?As medical director of Maine Molecular Imaging, I have significant experience with, and dedication to, patients in need of FDG-PET imaging. The same is true for many of my colleagues throughout the network of physicians affiliated with the Center for Diagnostic Imaging.

?We applaud CMS for proposing to end the prospective data collection requirements under Coverage with Evidence Development (CED) for all oncologic indications for FDG-PET imaging. We are likewise encouraged by your decision to cover one FDG-PET scan for subsequent treatment strategy indications for all cancers (except for prostate cancer), based on data available to date.

However, we are highly concerned about the lack of defined coverage for subsequent PET imaging beyond that one subsequent treatment study, as such additional study coverage has been left to the discretion of the local Medicare Administrative Contractor.

There are numerous reasons that coverage of additional subsequent treatment studies for a wide variety of malignancies is critical to the oncologic care of these patients. The change in patient management directed by obtaining these studies, especially in patients who demonstrate recurrent or refractory disease, has resulted in such an approach now being the standard of care in the oncologic community, and should be reflected in any CMS proposal on coverage. The physiologic imaging capabilities of FDG-PET result in the detection of residual or recurrent disease with far more sensitivity and specificity than any other modality, with resultant chemotherapeutic and radiation treatment initiated far sooner than would have been possible without such an approach. Likewise, those patients with refractory disease rely on additional scans to help define what oncologic treatments might actually help to mitigate the progression of their particular malignancy.

By not defining additional coverage strategies beyond one subsequent treatment study, CMS has created a system whereby the local MAC is empowered to arbitrarily decide who may or may not benefit from additional testing. Based on factual evidence and experience to date, we submit that the physicians directing a patient’s care are in the best position to answer that question. Therefore, we would emphasize our recommendation that CMS reconsider its policy as it pertains to subsequent treatment FDG-PET imaging to recognize that need.

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1. I applaud the plan to eliminate the cumbersome CED requirement for FDG PET imaging for oncologic indications.

2. A recent news flash indicated that cancer victims are surviving longer. To me, this was a testament to our success in treating malignancies guided by new findings in medicine including the realization that malignancies are a heterogeneous group, and that therapy is not uniform for every case at any time; hence the term, personalized therapy. Although we know that certain therapy approaches work better than others, we also now know that an important aspect of applying a therapy to a particular patient with cancer also requires timing and modification of certain strategies in the planned treatment. Take the example of a patient receiving combined chemotherapy and radiation therapy for esophageal cancer or head and neck cancer. At a time that the intravenous drug is exerting its effects with creation of necrosis within the tumor, appropriate application of radiation dose requires that the graduated dose be readjusted in the field so that much of the radiation goes to the oxygenated portion of the tumor and not be wasted in necrotic tissues where the radiation is just a wasted exposure. This is basic science. In this instance, the information provided by FDG PET is paramount to successful application of a therapeutic approach. Similarly, to wait for series of chemotherapy that is not optimally working to finish before deciding to change it to one that might work is just irrational and perhaps criminal. We simply cannot go back to the archaic ways of the distant past of waiting and abandon the lessons and successes that we have worked so hard to achieve with the help of FDG PET. To what end? Granting that there is no set protocol for FDG PET imaging in follow up, the fact of the matter is, each cancer care center has managed to be successful with their unique population of patients with cancer. How else did we all manage to achieve more durable cancer survivorship? As heterogeneity in cancers increases, so must our approach be different from each other even in interpretation of FDG PET images.

Your proposal to limit FDG PET imaging for subsequent treatment strategy until the end of proposed therapy is truly perplexing when we now understand much more.

3. Your proposal to have a local Medicare administrator to determine whether or not additional FDG PET is required is akin to creating Obama-Boehner showdown in medicine. Both believe that they have the interest of their respective public and look at where this bureaucracy has gotten us all. To this day, much discussion continues from both camps. In our case, should this plan come to fruition, the only one that may end up in bad sequester is the patient with cancer. Let us not do this to anyone.

Please reconsider carefully the implications of your proposals on FDG PET imaging in subsequent treatment strategy. While you look at different data regarding the usefulness or wastefulness of FDG imaging in cancer care and believe whichever way, listen to us who are faced with daily decisions to make for each life with cancer. WE, you and us, are in medical practice, not politics, not economics. We should be better that the bureaucrats in Washington DC. We should continue the successful prolongation of a cancer survivor’s life. What is the matter with us that we are even in this discussion?

Charito Love, MD
Montefiore-Einstein Center for Cancer Care
Montefiore Medical Center
Albert Einstein College of Medicine
Bronx, New York

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As the Co-chairs of the National Oncologic PET Registry (NOPR) Working Group, and the initiators of this reconsideration request, we greatly appreciate the work of the Centers for Medicare & Medicaid Services (CMS) over the past several years to expand Medicare beneficiary access to FDG PET imaging through the NOPR Coverage with Evidence Development (CED) clinical study. We strongly support the CMS conclusion in the Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4) to end CED data collection requirement for FDG PET for oncologic indications.

However, we are deeply concerned that the proposed single scan for subsequent patient management would restrict current coverage for many oncologic indications and be at odds with clinical practice and treatment. This letter provides our comments and suggested revisions to the proposed decision to both reflect the published data and standard of care for patients while attempting to safeguard CMS’ concerns with potential inappropriate use of PET imaging.

The NOPR was launched as a clinical study in 2006, in response to a CMS proposal to expand coverage for ¹⁸F-fluorodeoxyglucose positron emission tomography (FDG PET) to cancers and indications not previously eligible for Medicare reimbursement. CED allowed Medicare beneficiaries with less common cancer types to have equal access to PET in order to inform clinical management decisions, in conjunction with prospective data collection within the NOPR. The primary objective of the NOPR was to measure the impact of PET on the referring physician’s intended patient management by collecting questionnaire data before PET and again after the PET results are available for decision making.

Since 2006, the NOPR has implemented this registry and shared the resulting data with CMS. In the NOPR’s first phase, from May 2006 through April 2009 (known as “NOPR 2006”), approximately 133,000 PET scans from nearly 1,900 PET facilities—representing more than 90% of all U.S. PET sites—were covered by Medicare via the NOPR. On April 3, 2009, CMS substantially revised its coverage policy for cancer-related PET. This revised policy provided coverage for PET for initial treatment strategy evaluation for essentially all cancers, with a few selected exceptions. Additionally, coverage for subsequent treatment strategy evaluations (including treatment monitoring, restaging after completion of treatment, and evaluation of suspected recurrent disease) was expanded to a total of ten common cancer types.[1] However, for numerous less frequent cancer types (which together represent about 10% of incident cases in the elderly), FDG PET for subsequent treatment strategy evaluations remained covered by CMS only pursuant to CED. Since April 2009, complete data have been submitted for approximately 139,000 additional scans undertaken under this new phase of the NOPR (known as “NOPR 2009”).

As stated above, we strongly support the proposal to remove the remaining prospective data collection requirements for FDG PET imaging for those oncologic indications where such scans continue to be covered under Coverage with Evidence Development (CED).[2] As we noted in our current reconsideration request, our data demonstrated that the impact of FDG PET on intended patient management was essentially the same in the NOPR 2006 and NOPR 2009 cohorts.[3] In conjunction with the 2009 National Coverage Determination (NCD) that removed CED for an initial treatment strategy evaluation for a range of oncologic indications, we believe that removing the remaining CED requirements will benefit Medicare patients with solid tumors (and their treating physicians) by providing the demonstrated advantages of FDG PET for subsequent patient management without imposing the data collection burden currently required under the NOPR. We agree with the CMS conclusion that there is substantial evidence demonstrating that FDG PET is reasonable and necessary under these circumstances, and the prospective data collection requirement should end.

However, we very strongly oppose the proposal to restrict the use of oncologic FDG PET for subsequent patient management to coverage of a single lifetime scan, with additional scans to be covered at the discretion of local Medicare Administrative Contractors (MACs). As articulated below, such a strict and broad-based limit is neither clinically or scientifically warranted nor administratively desirable, and should not be finalized.

The NOPR formal reconsideration requested letter submitted on July 20, 2012 focuses only on indications currently covered under CED. The Proposed Decision Memorandum states clearly that the scope of the reconsideration is “limited to these uses currently covered only under CED”. As CMS knows, the 2009 reconsideration of the NCD in CAG-00181R3 removed CED for subsequent patient management for ten common cancers, and instituted national coverage without restriction. Thus, only a subset of cancers remain “currently covered only under CED.” However, it is now our understanding that CMS intends this one-scan limitation to apply to subsequent patient management for all solid tumors, including those indications for which CED was removed and for which national coverage currently exists pursuant to CAG-00181R3.

Although we oppose the imposition of a one-scan national limitation for any indication—for the reasons articulated in more detail below—we believe that the proposed should not make any changes in coverage for those indications that were finally addressed in CAG-00181R3. We encourage CMS to clarify in the final decision memorandum that this policy only applies to tumors currently covered under CED in the NOPR 2009.

Regardless of whether the proposed one-scan limit applies only to those indications currently under CED or to all oncologic indications, the imposition of a one-size-fits-all national limit of one scan for subsequent patient management has no clinical or scientific basis. This proposal should not be finalized.

NOPR recognizes and supports CMS’s stated concerns about the potential unnecessary use of imaging—including PET, CT and MRI. We agree with CMS that imaging should only be utilized where there is a clinically supported basis for ordering the scan for staging or treatment management purposes. However, we firmly believe that imposing a one-scan coverage limitation for subsequent treatment strategy evaluations for all oncologic indications is an excessively blunt approach that does not reflect the data or current clinical practice.

We have analyzed NOPR 2006 and NOPR 2009 data, focusing on those cancers for which subsequent treatment strategy PET could only be performed under CED in both cohorts. Out of a total of approximately 111,000 patients meeting this definition, 69.0% had a single subsequent treatment strategy scan, 16.3% had two scans, 6.8% had three scans, and 3.4% had four scans. Only 4.5% of patients had more than four scans.[4] These data suggest to us that only a small fraction of NOPR scans—almost certainly less than 10%—are even arguably being used for surveillance purposes. CMS should not be imposing a blanket limitation as a means for attacking a problem whose scope is empirically quite small.

Furthermore, the NOPR data indicate that the impact of PET on change in intended patient management, although decreasing somewhat, remains substantial across multiple scans performed over time. Shown below are the frequencies of change, associated with that particular scan, between treatment and non-treatment (the primary metric we have used in published NOPR analyses) for NOPR 2009 patients having their first, second, third or fourth PET scan for restaging or detection of suspected recurrence.

We have similarly analyzed the changes in planned actions for patients in the NOPR 2009 cohort undergoing their first, second, third or fourth scans for treatment monitoring (not necessarily the same continuous treatment). As is shown below, the frequencies of modifying dose, switching or adding therapy, or stopping therapy are essentially uniform over multiple encounters.

The data shown above [5] strongly indicate that additional scans are being ordered by physicians not for routine surveillance purposes, but to actively manage clinical problems in their patients.

More importantly, in many patients, the prevailing standard of care typically involves more than one subsequent treatment strategy scan for patient management. Two common cancers types in the elderly where this is particularly true are lymphoma and colorectal cancer. In both cases patients may be treated with curative intent, even when they have extensive disease. Hence, staging, restaging and treatment assessment are important in reaching this goal.

In most patients with Hodgkin lymphoma or aggressive non-Hodgkin lymphoma, FDG PET is obtained during the course of first-line chemotherapy and therapy is often being altered in those patients without metabolic response. PET is obtained for restaging after completion of first-line chemotherapy. PET is then obtained again for restaging in those patients who develop recurrent disease, and the sequence of imaging evaluations is repeated during second-line chemotherapy.

In patients with colorectal cancer who have completed primary surgery without or with adjuvant therapy, at least two subsequent treatment strategy scans are quite common, in a patient population (age > 65 years) where the median survivorship exceeds 18 months and multiple courses of different cytotoxic and biologic therapies are the norm. For example, a common two-scan combination occurs in a patient found to have potentially resectable metastatic disease to the liver on follow-up CT. The first PET scan is performed to assess the full extent of hepatic disease and to detect extrahepatic metastases before the patient undergoes metastasectomy. Most such patients will undergo at least one other PET scan for restaging after first-line chemotherapy for metastatic disease. Such patients may then develop further recurrences that are still amenable to surgical or ablative therapy with curative intent. This can lead to additional scans over the course of subsequent treatments.

For CMS to establish that only one single scan will be covered as “reasonable and necessary” is at odds with the medical treatment procedure for these cancers where more than one scan is often necessary.

Additionally, restricting the use of FDG PET could create a perverse incentive for physicians to inappropriately decrease appropriate utilization of FDG PET and increase their utilization of covered technologies such as CT scans, thus potentially leading to the paradoxical result of CMS paying additional reimbursements overall for clinically inferior results. Furthermore, without the availability of PET, patients may continue to undergo ineffective, inappropriate and costly treatments.

In conclusion, we encourage CMS to recognize the medical reality that cancer patients have improved outcomes, as a result of better and more tailored medications, targeted radiotherapeutic and surgical techniques, in conjunction with treatment monitoring strategies. As a result, decisions as to the optimal treatment strategy has evolved into a series of decision points during the patient’s care, whereas even a decade ago there may have only been a binary decision at a single point for the majority of patients. These multiple decisions should be informed by the best diagnostic information available. Where CMS has established that the evidence demonstrates that FDG PET is reasonable and necessary in assisting physicians make informed decisions as to patient management, it is arbitrary and unreasonable to limit the use of FDG PET to a single baseline study and a single post-treatment examination.

In addition to the clinical reasons for not restricting PET for subsequent treatment strategy evaluation to a single scan per patient, per cancer, there are serious administrative reasons not to finalize this proposal.

The proposed decision provides local MACs with discretionary authority to cover additional scans if medical necessity is demonstrated. Yet as noted above, for many indications the prevailing standard of care warrants multiple scans. As a result, MACs will almost certainly be inundated with physician requests for appeals of rejected claims for what are in practice medically routine, reasonable, and necessary scans. MACs will be forced to devote significant time and resources to managing these requests, imposing a burden not only on the local contractors but on PET facilities and treating physicians who will be forced to navigate the appeal process.

As a result, the most likely—and most troubling—outcome of the delegation of approval for additional scans to the MACs is that PET facilities will feel they have no choice but to require beneficiaries who are still in the course of active treatment to sign Advance Beneficiary Notification (ABN) forms. As a result, thousands of Medicare beneficiaries will be informed that there is a possibility that they will need to pay out of pocket for a service that currently may be covered for their indication. Many beneficiaries may decline to sign the ABN, and therefore would not receive a scan. CMS should avoid placing its cancer patients in the entirely unnecessary position of having to potentially choose between continuing their recommended treatment and incurring thousands of dollars of out of pocket costs. One of the objectives of the decade long Medicare coverage review of FDG PET was to provide beneficiaries with certainty with regard to coverage and protect beneficiaries from facing such choices.

In place of the proposed one-scan limit, we respectfully request that CMS adopt language that would nationally cover FDG PET for oncologic indications without restriction, but allow local contractor discretion to establish frequency limitations as medically reasonable, as is currently within their authority. At the same time, we support CMS in reiterating and reemphasizing its policy not to cover FDG PET (and other advanced imaging) for surveillance (perhaps by providing a clear definition of what constitutes a surveillance scan), and stating its intent to work with local contractors to monitor claims closely for any improper surveillance claims. The MACs have the ability to look for aberrant patterns of use, and this is the most appropriate method to identify potential inappropriate use of PET for surveillance. We believe that this approach would balance the medical necessity of FDG PET for beneficiaries with the understandable desire of CMS to curtail the potential inappropriate use of FDG PET, such as in for surveillance in low-risk populations.

While this change may appear subtle, it would have a profound impact on the implementation of FDG PET policy in practice. By instituting national coverage rather than a one-scan limit, CMS would acknowledge that FDG PET is reasonable and necessary for all uses other than surveillance. Instituting national coverage, CMS would also provide flexibility within the NCD itself to accommodate uses of FDG PET for indications that require multiple scans as standard of care. Furthermore, by establishing that the appropriate default status of FDG PET is coverage (rather than limited coverage), CMS would convey an important message to local contractors. While MACs would retain their prerogative to impose frequency limits, a policy of national coverage would indicate to MACs that any frequency limits should not be automatically set at N=1, but rather should be established—if at all—with sensitivity as to the specific type of cancer and its established treatment protocol. NOPR would of course be pleased to encourage the professional imaging societies and cancer-specific patient advocacy organizations to collaborate with CMS in developing guidance on how best to implement such frequency limits.

NOPR would also be pleased to collaborate with CMS to develop strategies and methods for limiting the inappropriate use of FDG PET such as for surveillance in low risk populations. Such measures could include developing requirements for documentation of signs and symptoms coupled with a V-code for personal history of cancer, as a means for establishing that a physician’s request for imaging is being made for a patient who has evidence of or suspicion of active disease. However, the imposition of a universal one-scan limit ignores the well-documented medical heterogeneity of cancer and the numerous variations in standard treatment across (and even within) indications. The vast majority of physicians and beneficiaries who utilize multiple subsequent patient treatment scans responsibly should not suffer as a result of an effort to eliminate isolated instances of imaging overuse.

The Proposed Decision proposes to remove the CED requirements and institute national coverage for all solid tumors with the specific express exception of prostate cancer, which would remain non-covered. Without referencing any specific literature, the Proposed Decision concludes that “the body of evidence as a whole argues against the persuasiveness of the NOPR results on this issue [of coverage for prostate cancer].”

We respectfully disagree, and encourage CMS to reconsider this proposal based on the NOPR data (discussed in the Proposed Decision) and the published literature to the contrary.[6] Prostate cancer is a heterogeneous disease, and FDG PET has been demonstrated to be effective in small subsets of prostate cancer patients, particularly those with advanced castrate-resistant disease. We agree that FDG PET is of limited utility for diagnosis or initial staging of prostate cancer (and, hence, we were in agreement with the 2009 CMS decision to non-cover FDG PET for initial treatment strategy evaluation of patients with prostate cancer). Although FDG PET is less sensitive than alternative PET tracers for detection of recurrent disease in men who develop biochemical recurrence of their disease after radical prostatectomy or radiation therapy, it is a useful means to assess the extent of disease in such patients, especially those with higher PSA levels.[7]

While we acknowledge that alternative prostate imaging tracers, such as C-11 choline, have recently attracted significant attention, the vast majority of Medicare beneficiaries have no access to C-11 choline-PET. C-11 choline is the only PET radiopharmaceutical specifically approved by FDA for evaluating biochemical recurrence; however, this agent is approved only for use at a single site in the United States—Mayo Clinic-Rochester. The time to approval of abbreviated NDAs for C-11 choline at multiple other sites in the country is likely to be very lengthy. While physicians should be encouraged to utilize FDG PET in a targeted manner in the context of prostate cancer (e.g., for treatment monitoring of men with metastatic castrate-resistant disease), the availability of an alternative tracer should not preclude the coverage of widely-available FDG PET for those beneficiaries for whom it would be of use. Use of FDG PET to assess men with castrate-resistant is of increasing importance given the approval within the last few years of several new, effective (but expensive) therapies for this subset of patients.

Additionally, we note that use of FDG PET in men with prostate cancer is already highly selective. In the Proposed Decision, CMS notes that the annual incidence of prostate cancer is approximately 240,000 and the annual mortality is approximately 28,000. Accordingly, the prevalence of this disease in the US population is considerably greater than the incidence. In our published results for the NOPR 2009 cohort, data spanning a 31-month interval included only 5,465 PET scans for restaging/suspected recurrence and 1,336 for treatment monitoring of prostate cancer (out of a total of 73,358 scans done for all NOPR 2009 cancers for these indications).[8]

It is imperative that as FDG PET moves from CED to national coverage, beneficiaries who are currently receiving coverage pursuant to CED are transitioned seamlessly to national coverage. To ensure a smooth transition, we would request that CMS establish the termination date for NOPR data collection to be the same as the effective date of the final NCD (for PET scans performed on or after the effective date).

Although CMS proposes that FDG PET be covered when used to guide subsequent physician management of anti-tumor treatment strategy after completion of “initial anticancer therapy,” this term is not defined anywhere in the Proposed Decision. Currently, a treatment monitoring scan performed during first-line chemotherapy is classified as a component of subsequent treatment strategy evaluation within the NOPR construct and the general use of the PS modifier in the community. Therapy done with curative intent for some cancers now regularly consists of a series of treatments, which include combinations of chemotherapy, surgery and radiotherapy, given over many months. Treatment monitoring/restaging may be appropriate at one or more points during this sequence, e.g., to document that patients have not developed distant progressive disease after completion of neoadjuvant chemoradiation, before undertaking radical surgery. We request that CMS define the scope of the phrase “initial anticancer therapy” and encourage CMS to clarify that treatment monitoring performed during “initial anticancer therapy”, to identify early treatment failures, would continue to be covered under the revised NCD.

It also appears that in Appendix A, the listing of tumor types is mistaken. Specifically, the table does not list the ten cancers for which both Initial ATS and Subsequent ATS PET scans are covered, without need for CED-related data collection, in accordance with CAG-00181R (2009). These are the following: breast, cervical, colorectal, esophageal, head and neck, non-small cell lung and ovarian cancers, as well as lymphoma, melanoma and myeloma.

For the past seven years, NOPR has collected and analyzed hundreds of thousands of FDG PET scans for oncologic indications pursuant to CED. The result is clear: FDG PET is a reasonable and necessary diagnostic tool whose use has significant value in guiding the treatment management of thousands of Medicare beneficiaries. There is no clinical rationale for the agency to continue the data collection for FDG PET for these purposes. We support the proposal to end CED and establish national coverage for oncologic uses of PET.

However, we are very concerned by the proposal to replace CED with national coverage for only a single scan at the subsequent patient management phase, as well as the proposal to extend this restriction to all oncologic indications. Where CMS has concluded that oncologic FDG PET is reasonable and necessary for non-surveillance purposes, decisions about when FDG PET should be deployed should be reserved to the treating physician and the beneficiary, subject to reasonable frequency limitations established by local contractors.

We appreciate the time and effort that CMS has invested in oncologic FDG PET over the past seven years, as well as the willingness of CMS to collaborate with the NOPR in its goal of developing data-driven coverage decisions. We believe that the data demonstrate that the appropriate coverage for FDG PET is national coverage, and look forward to working with CMS to establish and implement such coverage for Medicare beneficiaries.

Sincerely,

/s/
Bruce E. Hillner, M.D., Chair

/s/
Barry A. Siegel, M.D., Co-chair

/s/
Anthony F. Shields, M.D., Co-chair

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PET scanning is a valuable tool for oncologists to assess the efficacy and response to treatment of our cancer patients as well as occult metastatic disease evaluation. In our practice, PET scans are used as necessary when signs and symptoms of disease progression appear. The proposed limitation of PET use to 2 scans for the life of the patient will seriously impact the timely evaluation of the patient for reoccurance of disease. By the time a CT scan is performed, the tumor growth is much more extensive than when a PET would detect it, having a significantly negative effect on the outcome of the patient's health. The sooner the physician can detect disease reoccurance or metatstatic disease, the smaller the tumor burden of the patient, and the more effective the treatment(s) can be. Why wait until the tumor is big enough for the patient to be grossly symptomatic until evaluation can be done when smaller tumor reoccurances can be detected and treated early? Please do not compromise the health and recovery of our patients by limiting the community-based oncologists to less effective and less sensitive modes of diagnosis! These are our family members and communities as well as our patients. They deserve the best and most effective therapy we can provide. I have been in the oncology laboratory field for 35 years — limiting PET scans for therapeutic and diagnostic use would be as effective as telling the patient that they would only be allowed one CBC or creatinine per month — no matter what kind of chemotherapy they got a week prior — let's just "guess" at how the chemotherapy affected their bone marrow cellularity/recovery and their kidney function! Thank you for your attention to this matter.

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I support the letter of commentary to CMS from the Joint Societies: The American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS).

Although I read the newspaper and care about the federal government's fiscal difficulties and understand CMS' desire to reduce spending, this particular approach, particularly the limitation via National Coverage Determination to 1 follow up PET scan per patient per cancer for treatment monitoring, will strike a blow to cancer patients and cancer knowledge. The fiscally unfortunate, but nevertheless true, fact is that molecular imaging is increasingly proving itself via extensive peer-reviewed literature to be a vital tool in "precision medicine". "Precision medicine" refers to the realization among health care providers and researchers that the true knowledge of a disease involves understanding it at the very granular molecular level. For example, colon cancer is not one disease that affects an entire population in the same way, but rather a collection of molecularly distinct disorders that affect individuals differently based on their genetic and phenotypic susceptibility. Ideally, therefore, these diseases are treated in a specific, targeted manner. One of the only ways to peer into this deeper layer of disease complexity is to assess site-specific metabolic response of an individual's tumors to precision drugs and other precision treatments. And the only way to do get that molecular information that is with whole-body molecular imaging. Blood tests do not do it well. CT and MRI scans do it a little bit, but not well. Only molecular imagingpredominantly PETdoes it well. CMS needs to acknowledge, even if it can't afford to pay for it, that precision medicine is a scientific advance that will get biggermuch biggernot smaller. It needs to back down from the "one follow up scan" limitation and let individual contractors deal with the difficult details via Local Coverage Determinations.

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The proposal by CMS to limit the number of PET/CT scans for cancer patients to two, one for initial staging and one for follow up following first line therapy, is, in a word, ludacris.

What exactly should we tell our patients who have malignancies for which there are second, third, and even fourth line therapies available? For example, say we have a patient with a solid tumor who fails first line therapy which is proven with a follow up PET/CT where their disease is clearly no better or worsened. We offer them the second line therapy but then explain to them that the follow up PET/CTs from this point on will have to be paid for out of their own pocket. I guess we can try to placate them by saying we could order an inferior study that will be covered but is that what you would want if you were the patient. This proposal will diminish the quality of care we provide, plain and simple.

In the case of [PHI Redacted], who died of cancer last year, there is no way we could have adequately directly her treatment if she were limited to two PET/CTs to her lifetime. I plead with you to reverse this proposal for the sake of cancer patients nationwide. If the decision stands, God help you if and when you get diagnosed with one of these terrible diseases.

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Itis imperative that FDG-PET coverage for subsequent treatment strategy not be limited to one scan, with additional scans left up to determination by local MACs. Patients with many malignancies benefit from FDG-PET at initial staging and at multiple times for subsequent treatment strategy.

Addining additional administrative burdens for additional scans will pose an unnecessary burden on eveyone involved. This plan will only add costs and place patients at risk without any additional financial or patient care beneift.

We would be happy to provide more information if needed. Contact information is listed below.

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Dear sir:

I am an oncologist in a moderate sized Midwestern city. PET scans are invaluable part of restaging many different kinds of cancer and often avoid other imaging. Impeding the use of these will cause harm to my cancer patients.

The most important thing we do as oncologists involves making the correct decisions regarding chemotherapy, surgery or radiation. A good example of this is a patient with bone-only metastatic breast cancer. Often a PET is the only test that can clarify if a patient is progressing on her current therapy and if a change is needed. Another time I use it frequently is clarify response or relapse of a lymphoma. The activity on the PET is more important than the size of borderline lymph nodes.

Please continue to allow restaging PET scans in appropriate situations. Each patient must be looked at individually as to the decisions that must be made for him or her, and made correctly.

Parenthetically, I can recall editorials in the 1980s deploring CT scans and wondering why we would every need them! Could you imagine practicing oncology today without them?

I think that it is appropriate to ask physicians to justify in the chart why such a scan would help and how treatment decisions are to be make. Clear thinking in this regard is always helpful.

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April 10, 2012

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

RE: Comment on Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Dear Dr. Jacques:

Respectfully, please accept these comments regarding the proposed decision memorandum issued relevant to the cessation of Coverage with Evidence Development (CED) to include termination of the National Oncologic PET Registry (NOPR) relative to FDG, the expansion of coverage for PET with the limitation of one initial PET scan and one subsequent PET scan after completion of initial treatment strategy with subsequent decision making at the authority of the local Medicare contractor, and the denial to support coverage for subsequent PET scans used for treatment strategy for prostate cancer.

The cover of the Journal of Society of Nuclear Medicine, Volume 32, Number 34 of April 1991 displayed an image of a PET scan with the title stating "Clinical PET: Its Time Has Come". This remains well remembered because as a soon-to-be graduate of nuclear medicine technology many of us were excited to be part of introducing this modality to patients in the clinic. This graduating class studied, in addition to nuclear medicine, the principles of PET and Nuclear Magnetic Resonance, now MRI, with anticipation both modalities would have a large clinical impact on the care of patients immediately. MRI was supported by reimbursement while PET was scrutinized one diagnosis at a time delaying clinical implementation. Since 1991 research has continued to document the relevance of PET imaging to assist physicians in the management of patients with cancer. Supported by CMS, CED and implementation of the NOPR created a significant step forward to investigate the global clinical relevance of PET. Through this data collection effort, research supported and CMS recognized the relevance of PET by expanding coverage to the majority of cancers for initial treatment strategy. Additionally, CMS expanded the coverage of PET for subsequent treatment strategy for a smaller number of additional cancers. Clinically, these decisions have made a large impact on the care of cancer patients by being the eyes of physicians and putting a face to cancer for patients. Physicians and patients have a clinically necessary tool in PET to assist with real time clinical decision making with respect to initial treatment planning and continued therapeutic management.

The decision by CMS to limit the availability of this valuable tool to patients and blind physicians caring for cancer patients by more stringent restrictions, through reversal of previous decisions, would create a hostile climate for PET imaging and potentially lead to limited future clinical availability through infrastructure instability. CMS is encouraged to continue on the path of less restriction for PET imaging, as supported by previous coverage expansion decisions, by revising the proposed one PET scan limit for subsequent treatment strategy after initial anticancer therapy and replacing with language which would allow physicians to use PET based on clinical decisions focused on medical necessity. Removing the blindfold from physicians through this means would continue on a trend to more in-formed clinical based decisions assisting with directing patients to more cost efficient treatment planning, as well as, better therapeutic decision making leading to decreased cost and less discomfort to patients receiving anticancer therapy which is not working and giving comfort and support to those receiving successful therapeutic regimes. Additionally, this would create a pathway leading to earlier detection and management of recurrent cancers.

CMS is encouraged to incorporate the expansion of PET imaging without a scan limitation through the dictation of a National Coverage Decision (NCD) and to not defer ajudication to local Medicare contractors. A CMS dictate through an NCD will lead to clinical stability of PET for use by physicians and provide confidence to patients with regards to a uniformly applied national policy, insuring continued national access to PET scanning for all patients.

CMS is encouraged to continue to provide a means for the evaluation of PET scanning in patients with prostate cancer undergoing therapy or have suspicion of recurrence/metastasis. Prostate cancers have been generalized as being poor users of glucose. However, research demonstrates this generalization to not be true. Clinically, some prostate cancers/metastases are glucose users and a clinical subset of patients may benefit from PET scanning.

Finally, for those of us blessed with providing PET scans to patients daily, there is no doubt of the clinical relevance of PET scans seen through the appreciation of our patients. I recall one of the first PET scans I performed. A middle-aged cancer survivor lobbied the physician for a PET scan. While not severely symptomatic, the PET scan revealed early metastasis. Today's CMS proposal would potentially negate a current Medicare beneficiary from having this early detection. Please reconsider.

Thank you for your thoughtful consideration.

With kind regards,

Michael Kroeger, MIS, NMAA, PET, NCT

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Thank you for appropriately broadening the converage for tumors. coverage should not be limited to one scan. Patients benefit from the knowledge about disease progression, and response to treatment which avoids unnecessary toxic treatments. Current guidelines recommend subsequent scans to evaluate the treatment over the course of time. requiring tumor by tumor case by case approval for additional scans will pose unnecessary burdens and delays in care. Increased bureaucracy will increase the costs on the administrative side. I agree that PET should not be used for surveillance - but when there is a question where Pet can help it should not be denied. As a practicing oncologist I order scans when needed to address the appropriate clinical situation. It is not a routine test - but when needed there should not be so many administratve burdens placed as to make it too difficult to order.

I have several patients that have avoided unnecessary surgery for disease progression seen on PEt scan only and no on the routine CT. I have also had several patients where a PET helped to clarify a clinical situation and allow patient to go on a clinical trial.
Restricting patient's access to the technology will ultimatley not save money - but lead to more imaging to try to answer the question. Doing one PEt is less expensive than doing serially cT, MRI and nuclear med studies.

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The CMS proposal of limiting F18 fluorodeoxyglucose positron emission tomography (FDG PET) to one scan after completion of initial anticancer therapy is restrictive and fails to address the complexity of clinical situations when a physician may find serial PET advantageous to following cancer patients with very high risk of relapse or form disseminated disease. Althouth the proposal allows for coverage of additional FDG PET scans used to guide subsequent physician management of anti-tumor treatment strategy after completion of initial anticancer therapy but only after it is determined by local Medicare Administrative Contractors, this again has been restrictive and leads to excess CT scanning for many indications. I would hope the policy would decrease bureaucracy and enhance efficiency and care. In a number of areas of cancer care for patients with metastatic disease followup PET scans 3-4 times a year is necessary. For surveillance in patients with melanoma, recommendations for radiological assesment including PET for high risk patients is 2 scans per yer for upto 3 years or as symptoms or signs warrant.

We recognize that decrease cost is necessary and that over use of PET needs to be protected, but the current policy leads to increase overhead as requests need to filed by provider and responded to by CMS. Thus loosening of the restrictions is requested.

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First, I would like to thank you for appropriatly expanding the coverage of PET for several solid tumor testing. However, what concerns me most, is the proposed limited coverage in follow up diagnostic testing by PET for patients fighting cancer. PET is appropriate in post therapy for assess treatment efficacy. It is also valuable for evaluating suspected recurrence or progression of cancer.

I [PHI Redacted] have had many friends and family members on Medicare where the doctors have obtained valuable information by follow up PET Scans. As a Lab Manager in an oncology practice, I see we can gain quick and valuable information from follow up pet scans that cannot be obtained by other methods. Please do not cut the availabiltiy of this important test to our Medicare pateints.

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Dear CMS:

Clearly the CMS position re: PET for Solid Tumors is terrible misguided.

The limitation of 2 PET scans per patient per tumor is based on nothing scientific whatsoever.

A classic example is for the management of lymphomas. The limitation of PET scans for management of this disease could not be more ill-advised.

In addition, patients who have renal insufficiency and solid tumors, benefit from PET CT imaging due to the absence of iodine that worsens nephropathy.

Essentially, the current proposal is flawed, not evidence-based.

Sincerely

Lucio N Gordan MD

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I am concerned about the proposed decision memorandum regarding PET scans. There is considerable variation between different types of cancer and also between different stages of the same cancer. An arbitrary limit of two PET scans may be reasonable for some clinical situations but very unresonable for others. Used appropriately, PET scan can provide important information to assist with treatment decisions when cancer recurrence is discovered. As an example, PET scan can be useful in determining whether a patient who appears to have a solitary metastasis should undergo surgery. If the PET shows other areas of involvement, then surgery may not be apropriate. PET scans can also detect early recurrence when tumor markers are rising. By assessing response to therapy, PET scans help oncologists determine whether or not to continue with treatment.

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I am writing to express my support for the joint society letter from the ACR, ACNM, ASNR, SNMMI, and WMIS.

As a practicing radiation oncologist with a focus on thoracic tumors, PET is an invaluable tool for staging, assessment of response, and restaging after therapy.

In particular, the indiscriminate limit of an initial staging scan and one subsequent follow-up scan will adversely impact the following patient scenarios, which are common in my practice.

1. Patients with early stage NSCLC who receive definitive surgery or SBRT, and develop new pulmonary nodules or adenopathy. At least 5% of patients will develop new concerning nodules on multiple occasions throughout their follow-up period after their first intervention. Often, additional metachronous cancers can be effectively treated, but only if it can be justified with appropriate restaging. PET restaging or follow-up of suspicious nodules or adenopathy has the potential to be life saving for folks who otherwise might undergo inappropriate treatment (i.e., repeat surgery or SBRT if nodes are occult positive, or excessive treatment with chemoRT if they are negative).
2. Patients with locally advanced NSCLC or esophageal cancer undergoing trimodality therapy. While inter-treatment assessment of response for prognostic/predictive consideration is not standard at this point, an initial stage scan and restaging scan prior to surgery are necessary to prevent morbid treatment in a patient who might otherwise have already developed occult metastases, a scenario which occurs at least 5-10% of the time after induction therapy. A 2 scan limit would then prevent appropriate restaging when they develop new concerning findings on subsequent conventional imaging.

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[PHI Redacted] A friend alerted me to the opportunity to comment on the "proposed CMS decision memo to limit PET scan coverage to one scan after completion of anticancer therapy with subsequent scans determined by local Medicare Administrative Contractors." I have quoted her in portions of my response.

I support lifting CED and ending NOPR data collection as the data has provided sufficient information to issue an NCD for oncologic indications. Ovarian cancer patients, among others, have clearly benefitted.

I oppose limiting subsequent scans, after anticancer therapy, to one scan. Ovarian cancer can be very difficult to monitor. CT scans and blood tests are not reliable in all patients and our physicians need the option of PET scans when determining a course of treatment during recurrence.

Regardless of the patient condition, stage or need, she/he would be limited to one scan. This means, then, that local MACs will determine coverage. Ovarian cancer patients have already experienced unhappy vagaries of care when local MACS made differing decisions regarding chemotherapy coverage.

This amounts to “economic triage,” those who can afford to risk uncovered expenses or can afford to fly to other regions get care, those who can't get lesser care.
“Patients may be asked to sign an ABN, most if unable to pay, will opt not to have the scan. This was the situation prior to the NOPR study: patients securing short-term monthly installment loans, at a high rate of interest, more worried about the loan than scan results!”
Please reconsider this decision memo. It is not beneficial to patients as currently proposed.

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Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

April 10, 2013
Via Electronic Delivery

Dear Dr. Jacques,

As leaders in oncology and cancer imaging at the Perelman School of Medicine and the Abramson Cancer Center at the University of Pennsylvania, we wish to comment on the Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4). We applaud the CMS decision to broaden coverage for PET to all cancers and to include coverage for both initial diagnosis and for subsequent patient management. However, we are deeply concerned about Memorandum’s intent to limit coverage to only a single PET scan for subsequent patient management. The Memorandum implies that the one-scan limit will apply not only to those cancers included in the National Oncologic PET Registry (NOPR) Coverage with Evidence Development (CED) clinical study, but also to other cancers that were previously covered for subsequent management without restrictions, as outlined in CMS decision, CAG-00181R3. The group of previously covered cancers includes common cancers for which PET is widely used in directing subsequent patient management, including lung cancer, breast cancer, colorectal cancer, and lymphoma. The decision to restrict PET use for subsequent patient management to a single scan is at variance with current practice and is not warranted. PET is highly accurate in identifying ineffective therapy, and it has become a key tool for limiting patient exposure to treatment unlikely to be beneficial, saving considerable toxicity and expense.

The one-scan limit disadvantages patients whose disease progresses during or after initial cancer therapy. Studies have shown that PET is accurate in identifying persistent or recurrent cancer after initial therapy and that PET results predict subsequent patient outcome [Mankoff, 2007; Weber, 2009]. Analysis of the NOPR data showed that PET frequently affected therapeutic decisions when obtained to guide subsequent patient management [Hillner, 2008]. With the increasing array of possible treatments for many cancers, identification of effective versus futile therapy is key for treatment decisions, avoiding toxic and expensive treatments that are unlikely to be helpful. This is an especially important application of PET for patients who fail initial treatment, and who would be denied an appropriate subsequent follow-up PET by a one-scan rule. Some specific examples are as follows:

1. Neo-adjuvant or pre-operative therapy using systemic therapy +/- radiotherapy has become an important part of treatment for many cancers, including lung, breast, esophageal, and head and neck cancers. In all of these cancers, PET has been shown to be accurate in measuring response and predicting the likelihood of recurrence [Ajani, 2012; Dose-Schwartz, 2005; Jayachandran, 2012; Lordick, 2007]. The high likelihood of disease recurrence in patients with persistent FDG uptake after therapy indicates the need for further treatment, for which a second post-therapy PET would be helpful to judge the efficacy of alternative treatment. A recent review cited PET as being important in directing therapy in such patients [deGeus-Oei, 2012]. Limiting patients to one post-therapy PET scan would eliminate the ability to use PET to judge the efficacy of alternative treatment, placing patients who fail initial therapy at a significant disadvantage. In addition, it will hinder our capacity to differentiate recurrent tumor from progressive radiation fibrosis, which, on CT imaging, is often misinterpreted as recurrent or progressive disease. This dilemma arises frequently in patients with locally advanced NSCLC treated with combined modality therapy.


2. In patients with colorectal cancer metastatic to liver, a randomized trial of PET prior to surgery showed that PET reduced the number of futile surgeries for resection of liver metastases [Ruers, 2009], an approach that is effective in prolonging survival, but only if disease is confined to resectable sites in the liver. By the one-scan rule, patients who underwent initial staging and follow-up PET after therapy would be denied the use of PET to direct therapy at the time of a subsequent liver recurrence, despite the proven benefits of PET to direct hepatic metastasis resection.


3. In patients with bone-dominant breast cancer, a number of treatments have been shown to be effective, offering patient’s prolonged survival. Standard imaging methods such as CT, MRI, and bone scan are ineffective in assessing bone metastasis response. PET is accurate in measuring breast cancer bone metastasis response and is predictive of progression-free survival and skeletal-related events [Specht, 2007; Tataeishi, 2008]. Patients with bone-dominant disease may undergo a number of treatments over the course of their disease, and they may benefit from changes in their therapy when a particular treatment has ceased to be effective. The one-scan rule would deny these patients a highly effective means of guiding treatment selection, avoiding futile therapy, and directing them towards treatments that might be more effective.

We commend the CMS decision to broaden coverage for PET to all cancers. We recognize that there is clearly more work to be done in identifying the most appropriate and effective use of PET for subsequent patient management; however, limiting patients to s single post-therapy PET scan is not an appropriate means of directing PET use in this clinical setting. We strongly urge CMS to remove the restriction in the use of PET for subsequent patient management to a single scan, as implied by Decision Memorandum CAG-00181R4. We suggest, rather, that CMS support coverage scans for subsequent management based upon individual patient needs and the sound medical judgment of cancer practitioners.

Sincerely,

Chi Van Dang, MD, PhD
John H. Glick, M.D. Abramson Cancer Center Director's Professor
Director, Abramson Cancer Center

John Glick, MD
Madlyn & Leonard Abramson Professor of Clinical Oncology
Vice President, University of Pennsylvania Health System

Stephen Hahn, MD
Henry K. Pancoast Professor of Radiation Oncology
Chair, Department of Radiation Oncology

David Mankoff, MD, PhD
Professor of Radiology
Chief, Division of Nuclear Medicine and Clinical Molecular Imaging

Lynn Schuchter, MD
C. Willard Robinson Professor of Hematology-Oncology
Chief, Division of Hematology Oncology

Mitchell Schnall, MD, PhD
Eugene P. Pendergrass Professor of Radiology
Chair, Department of Radiology

References

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The new guidelines regarding limiting PET/CT scans appears to be too limited in at least 2 specific clinical scenarios:
1. Patients often will not be free of disease after the first post-therapy PET/CT scan and therefore undergo further treatment. It would be greatly beneficial, if not imperative, to continue to monitor therapy with PET/CT in these patients.
2. Patients in remission may eventually have recurrence/relapse or development of a new tumor. These patients should be allowed to have another round of PET/CT scanning.

I applaud the CMS for allowing coverage for many solid tumors that were not previously covered. I equally applaud the attempt to guide judicious use of PET/CT imaging in prostate cancer.

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I fully support the position letter from the societies of ACR, ACNM, ASNR, SNMMI, and WMIS.

Limiting one scan for patient's will severely affect patient care by reducing the availablility of a proven and effective diagnostic tool in PET-CT. Not only will patient care suffer, but many additional procedures and treatments may be implemented in the absence of PET-CT. I have spoken to many patients including my own family members who would be devastated by the lack of access of PET-CT for their cancers. Thank you for reading and considering my opinion.

Umesh Oza, MD

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With respect to FDG PET-CT examinations performed for oncologic imaging, I want to express my concern about the proposal to limit post-treatment management examinations to one study per patient per malignancy. This would be a drastic change in the way cancer patients are currently managed, and would be considered to be inferior to the current standard of care. Surveillance imaging with more than one FDG PET-CT examination is critical to the continued management and monitoring of patients undergoing cancer treatment, and limiting post-treatment FDG PET-CT examinations to one examination would harm countless patients.

Additionally, I want to express my full spport for the previously posted joint society letter of the ACR/SNMMI/WMIS, the conclusion of which is attached below:

Conclusion
The Joint Societies — WMIS, SNMMI, and ACR — believe that the NOPR has successfully achieved the purposes for which CED was intended: to provide a rich and robust clinical data source from which to analyze the value of FDG-PET for oncologic indications, while simultaneously providing Medicare beneficiaries diagnosed with cancer with access to advanced imaging technology. We believe that the published peer-reviewed clinical research demonstrates that FDG-PET is reasonable and necessary as to physician decision making for oncologic indications, and that CED data collection can be terminated without detriment to CMS, providers, or Medicare beneficiaries.
We look forward to continuing to work collaboratively with CMS to make innovative imaging technology available to the providers and patients who will benefit most from its use, and are of course pleased to provide CMS with any additional information that it may find useful in reaching its decision on this reconsideration request.

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On the behalf and in consult with our physicians, I have reviewed the proposed changes to policies affecting the use of PET for Solid Tumors. We appreciate the broadened clinical indications and feel this will be a more effective clinical and economic tool to properly manage cancer patients.

However the new policy states that an oncologist would be limited in using PET as an imaging technique to track the effectiveness of treatment. When using chemotherapy agents whether they are high or low cost, it is proven to be effective practice an oncologist to use PET after the 3rd cycle of a first line of treatment. If this is used at this time the progress of treatment can be measured, a rational decision can be made to proceed with the current therapy or transition to a second line theapy.

If this rule is applied, the provision of any future scans could be revoked and payment denied for the PET in an effort to effectively monitor the effectiveness of the second line or future therapies.

These policy recommendations, while broading diagnosis that can be monitored with PET, appears to be going against the data collected which shows that an average of 3 scans are used to monitor the cancer treatment of a typical patient for most common tumors. We have significant experience with this process and key decisions to continue or change treatment have been made by our physicians by using PET helping to assure we are properly managing the cancer treatment of our patients. Exposing patients to chemotherapy needs to be monitored to assure the proper treatments are being provided.

We recommend the committee consider allowing at least a baseline scan and up to 3 additional scans for each patient.

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April 8, 2013

To whom it may concern:

I am writing to express my informed concern and uneasiness with the plan for CMS to provide coverage for the evaluation of treatment interventions, including PET scanning for all cancers, except prostate cancer. Also, CMS is proposing to limit the number of PET studies for treatment evaluation to a single scan as well as instituting significant roadblocks and difficulties for reimbursement of additional scans. The current CMS proposal reverses prior coverage decisions without any data in support of this change.

I have learned from colleagues that the proposed coverage document acknowledges the role of FDG-PET for therapy response assessments. However, CMS has ignored the emergence of new and important treatments now available for many cancers. Recognizing the role of PET for identifying patients who respond to treatment but not to allow the patients the same imaging modality for other therapies known to be effective in these tumors is problematic.

There is an extensive body of literature indicating that patients with a wide range of cancers require and benefit from FDG-PET, CT and MRI. I would request that coverage for such imaging be unrestricted and include all patients prior to and during their treatment for cancer. Coverage decisions should be made by physicians caring for their cancer patients.

Regards,

Mark A. Israel, MD
Professor of Pediatrics and Genetics
Geisel School of Medicine at Dartmouth
Director, Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center

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I fully support the statement of the joint societies that, "The Joint Societies — WMIS, SNMMI, and ACR — believe that the NOPR has successfully achieved the purposes for which CED was intended: to provide a rich and robust clinical data source from which to analyze the value of FDG-PET for oncologic indications, while simultaneously providing Medicare beneficiaries diagnosed with cancer with access to advanced imaging technology. We believe that the published peer-reviewed clinical research demonstrates that FDG-PET is reasonable and necessary as to physician decision making for oncologic indications, and that CED data collection can be terminated without detriment to CMS, providers, or Medicare beneficiaries.

We look forward to continuing to work collaboratively with CMS to make innovative imaging technology available to the providers and patients who will benefit most from its use, and are of course pleased to provide CMS with any additional information that it may find useful in reaching its decision on this reconsideration request."

As a physician [PHI Redacted], I cannot overexpress the importance of accurate medical imaging and specifically PET, PET/CT, CT and MRI in the diagnosis, treatment and accurate medical management of oncologic patients. Treatments are cost effective if they are medically effective, and they can only be medically effective if based upon accurate medical diagnostic information.

Sincerely,

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The American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Society of Neuroradiology (ASNR), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the World Molecular Imaging Society (WMIS) are pleased to provide this joint comment on the proposal of the Centers for Medicare & Medicaid Services (CMS) to revise the current coverage status of FDG positron emission tomography (FDG PET) for solid tumors. Echoing our October 2012 comment letter, the joint societies strongly support the CMS proposal to end Coverage with Evidence Development (CED) data collection for the use of FDG PET for oncologic indications.

However, we strongly oppose the proposal that FDG PET coverage for subsequent patient management be limited to a single nationally-covered scan. We recognize and endorse the concerns of CMS regarding the potential for overuse of FDG PET for surveillance purposes. However, the one-scan limitation will have significant adverse effects for beneficiaries and treating physicians alike. We strongly urge CMS to revisit this proposal, and to adopt language in the Final Decision that instead provides for national coverage of FDG PET for subsequent patient management, subject to frequency limitations at the discretion of the local Medicare Administrative Contractors (MACs).

The signatories to this comment —WMIS, SNMMI, ACR, ACNM, and ASNR (the Joint Societies) — have been deeply involved in supporting the CED process through the National Oncologic PET Registry (NOPR), as well as in ensuring the success of the NOPR’s mission to collect evidence and publish its findings over the past seven years. We and others worked closely with CMS to launch the NOPR in 2006 as a clinical study, in response to a CMS proposal to expand coverage for FDG-PET to cancers and indications not previously eligible for Medicare reimbursement. Between both its 2006 and 2009 iterations, the NOPR has collected information related to nearly 280,000 scans over the past seven years, creating a rich and robust data source from which to analyze the value of FDG PET for oncologic indications.

ACR is a professional society with 36,000 members, drawn from radiologists, radiation oncologists, medical physicists, interventional radiologists, nuclear medicine physicians and allied health professionals. For over three quarters of a century, the ACR has devoted its resources to making imaging safe, effective and accessible to those who need it.

ACNM is comprised of physicians and other nuclear medicine professionals dedicated to enhancing the practice of nuclear medicine through the study, education and improvement of clinical practice. The goal of ACNM is to assure a legislative, legal, regulatory and economic framework that encourages and makes practicable the safe, appropriate use of nuclear medicine procedures to improve the quality of health care service available to patients.

ASNR is the premier professional association for neuroradiology, a subspecialty concerned with the diagnostic radiology of diseases of the central nervous system, brain, head and neck, through the use of advanced imaging technologies. ASNR is comprised of over 5,000 physicians specializing in neuroradiology, all of whom must devote approximately one-half or more of their professional practice to neuroradiology.

SNMMI (formerly the Society of Nuclear Medicine) is an international scientific and professional organization that promotes the science, technology and practical application of nuclear medicine. SNMMI’s more than 19,000 members set the standard for nuclear medicine and molecular imaging by creating guidelines, sharing information through journals and meetings, and leading advocacy on key issues.

WMIS is an international scientific educational organization dedicated to the understanding of biology and medicine through multimodal in vivo imaging of cellular and molecular events involved in normal and pathologic processes, and the utilization of quantitative molecular imaging in patient care. WMIS was formed in 2011, as a result of the merger of two of the premier molecular imaging societies — the Academy of Molecular Imaging (AMI) and the Society for Molecular-Genetic Imaging. Between 2006 and 2011, AMI was the sponsor of the original NOPR, and post-merger, WMIS has continued to sponsor the current iteration of the registry, NOPR 2009.

1. CMS Should Finalize the Removal of CED Requirements.

The Joint Societies believe that the NOPR has successfully achieved the purposes for which CED was intended: to provide a rich and robust clinical data source from which to analyze the value of FDG PET for oncologic indications, while simultaneously providing Medicare beneficiaries diagnosed with cancer access to advanced imaging technology. We agree with CMS that the published peer-reviewed clinical research demonstrates that FDG PET is reasonable and necessary as to physician decision making for oncologic indications, and that CED data collection can and should be terminated without detriment to CMS, providers, or Medicare beneficiaries.

2. CMS Should Not Finalize the Proposed One-Scan Limit.

The Joint Societies oppose the proposed one-scan coverage limit for subsequent physician management of anti-tumor treatment strategy. We believe that such a blanket restriction is both contrary to clinical good practice (as well as the clinical standard of care for certain oncologic indications) and will create significant administrative complications. We urge that CMS revisit this proposal, and instead adopt national coverage of FDG PET for subsequent treatment management, with the option of having MACs establish frequency limits if deemed necessary.

As a preliminary matter, the Joint Societies believe that the Proposed Decision is unclear as to the scope of the indications to which the reconsideration applies. The Proposed Decision expressly states that its scope is “limited to these uses currently covered only under CED,” which should include only those solid tumors that were not previously nationally covered via CAG-00183R3 (2009). We believe that the Final Decision should make changes only in coverage for those indications that were finally addressed in CAG-00181R3, and which CMS itself acknowledges were not the subject of this reconsideration.

Turning to the merits, the Joint Societies oppose the proposed one-scan limit for both clinical and administrative reasons. As to the former, we first fully recognize the concern that there exists a potential for the misuse of FDG PET for surveillance purposes. However, we believe that this concern can be safeguarded without a blanket one-scan restriction that penalizes the vast majority of beneficiaries and treating physicians. We propose several potential solutions below. Second, we are greatly concerned that the Proposed Decision would roll back established coverage for many patients where the standard of care requires more than one subsequent patient management scan. Many major cancers fall under this category, particularly those for which multiple lines of therapy can be effective if the initial treatment fails. These include breast cancer, lymphoma, lung cancer, melanoma, colorectal cancer, gynecological malignancies, and many more.

The Joint Societies are equally opposed to the proposed one-scan limit because of the administrative complications that will ensue in practice. First, under the Proposed Decision, local contractors would have the discretion to allow additional scans beyond the one nationally covered scan. However, as noted above, there are numerous situations in which more than one scan is not only “reasonable,” but also clinically “necessary.” A national policy that establishes the default coverage of only one subsequent treatment strategy scan encourages MACs to be skeptical of the necessity of subsequent scans, in deference to the NCD. Finalizing a national one-scan limitation will inevitably lead to a flood of physician appeals for coverage of what are medically necessary routine additional scans. Not only will these appeals require that MACs devote significant time and resources to reviewing these requests, but these appeals will inevitably lead to delayed treatment and reimbursement for beneficiaries and physicians alike.

Typically, with fee-for-service Medicare claims, the first-level appeals go through the customer service areas for the MACs, which almost always result in the same denial as the electronic submitted claim, forcing the facilities to enter into the second level of appeal. The second level at times will reach the medical policy staff to reverse the denial. However, those second level appeals also often can be unsuccessful, forcing the provider to give up in frustration, adopting a fallback position of using Advance Beneficiary Notifications (see below) or continuing the appeal process through the Administrative Law Judge. Under this administrative framework, a one-scan limit will inevitably lead to delays in coverage and reimbursement to the detriment of patients, physicians, and the MACs. Second, although the proposed decision nominally provides MACs with the discretion to approve additional scans, MACs in practice typically will take their lead from the NCD, which establishes that a single scan should be the default. This default position sends a strong message from CMS to the MACs that additional scans should be approved sparingly, which will lead to further expense and delays in the form of appeals.

The Medicare Advantage plans add a different layer of complexity through the prior authorization process that will lead to similar barriers to these medically necessary services. In the prior authorization process, a first-level review is almost always denied by non-clinical staff based on very restrictive rules. Next providers are forced to request a further medical prior authorization in the form of a peer-to-peer review. These reviews are labor intensive for the MACs and for referring physicians, taking away valuable time for both. It will thus be near impossible to schedule patients in a timely and efficient manner (which, in turn, will delay the appropriate treatment) leading to the possibility of severe adverse impacts on patient outcomes.

Based on our past experience working with local contractor policies for FDG PET, we believe that PET facilities will feel compelled to require their patients to complete Advance Beneficiary Notification (ABN) forms for medically necessary scans beyond the proposed one-scan national coverage limit. As a practical matter, it will be nearly impossible for providers to assure beneficiaries at the time of delivery that these additional scans will be covered, since under the Proposed Decision, coverage of all such additional scans will automatically be at the discretion of the MAC. As a result, we expect that thousands of beneficiaries will be forced to make the choice of either foregoing treatment or agreeing to pay out of pocket for the scan pending the determination of the MAC. Many beneficiaries may decline to sign the ABN, and therefore would not receive a scan. CMS should avoid placing its cancer patients in the entirely unnecessary position of having to potentially choose between continuing their recommended treatment and incurring thousands of dollars of out of pocket costs. This result is particularly troubling for those patients who are in the midst of treatment, as well as for those whose cancers require multiple subsequent scans due to the initiation of alternative treatments pursuant to the prevailing standard of care.

The Joint Societies encourage CMS to set aside the proposed one-scan limitation in favor a policy that would nationally cover FDG PET for oncologic indications without restriction, but allow local contractor discretion to establish frequency limitations as medically reasonable, as is currently within their authority. Furthermore, as explained above, we support supplementing such a proposal with a strong statement that CMS will not cover FDG PET for surveillance purposes in low-risk patients.

The Joint Societies recognize that the difference between national coverage (with the option for local frequency limits) and a national one-scan limitation (with the option for additional scans at local discretion) may at first seem semantic. However, the practical implications are substantial and wide-reaching. First, by instituting national coverage rather than a one-scan limit, CMS would acknowledge that FDG-PET is reasonable and necessary for all uses other than surveillance. Second, national coverage ensures that FDG PET will be available for indications that require multiple scans as standard of care, thus significantly reducing the stress and uncertainty that comes with the need to obtain ABN forms from beneficiaries. Third, MACs rightly look to CMS for cues as to when and how they should exercise their local discretion. The establishment of a one-scan limit encourages MACs to “enforce” that limit and to exercise their discretion sparingly, whereas a decision establishing a default of national coverage encourages MACs to establish frequency limits (if any) based on the type of cancer and its established treatment protocols.

The Joint Societies again acknowledge that CMS is rightly concerned about the use of FDG PET for surveillance purposes. We believe that there are alternative approaches available to CMS that could obtain the same desired result without establishing a one-scan across-the-board restriction. For instance, we believe that it would be possible to establish protocols requiring physician documentation of a patient’s clinical symptoms, in conjunction with a claim submitted with a V-code for the patient’s history of cancer. Moreover, it appears to be reasonable to indicate that a second, third, or fourth line of therapy is being considered, which in turn requires a new-“baseline” scan for subsequent response assessments. Together, this documentation plus coding could be utilized to demonstrate that a clinician’s request for additional imaging scans is grounded in both clinical judgment and the patient’s own clinical history, thus reducing the possibility that an additional scan will be ordered for a patient who is not presenting with either evidence of (or suspicion of) cancer. The Joint Societies would be pleased to collaborate with CMS to develop protocols that can be implemented to accomplish this end.

The Joint Societies believe that CMS should revisit the proposal to non-cover prostate cancer. While the Proposed Decision states that “the body of evidence as a whole argues against the persuasiveness of the NOPR results on [prostate cancer],” we believe that this conclusion does not reflect the available clinical literature.

We want to bring to the attention of CMS several clinical studies in the literature that provide evidence that FDG PET is quite useful in the imaging evaluation of men with castrate resistant prostate cancer.[1] These include assessment of the extent of metabolically active disease sites, treatment response evaluation, and prognostication. Based on the evidence provided in these peer-reviewed published articles, we strongly believe that CMS should include the use of FDG PET in the specific case of patients with castrate resistant metastatic prostate cancer.

It appears that in the Proposed Decision, CMS inadvertently failed to reference PET MRI in the definition on scanner technology. The recent Final Decision in CAG-00065R2 includes PET/MRI in the definition of PET:

We encourage CMS to clarify in the final decision memorandum that PET/MRI is included in the definition of what constitutes PET for purposes of FDG.

It is imperative that as FDG PET moves from CED to national coverage, beneficiaries who are currently receiving coverage pursuant to CED are transitioned seamlessly to national coverage. To ensure a smooth transition, we would request that CMS establish the termination date for NOPR data collection to be the same as the effective date of the final NCD (for PET scans performed on or after the effective date).

The Joint Societies—ACR, ACNM, ASNR, SNMMI, and WMIS—appreciate the opportunity to comment on the Proposed Memorandum, and to voice our overall support for the termination of CED and data collection requirements for FDG PET for cancer.

However, we continue to have very significant concerns about the proposal to limit subsequent patient management scans to one scan per patient per cancer. We strongly believe that limiting the use of FDG PET for surveillance can be achieved through less burdensome means, and without the adverse impact on beneficiaries, physicians, and local contractors that would be created through adoption of a blanket one-scan limitation.

We look forward to continuing to work collaboratively with CMS to make innovative imaging technology available to the providers and patients who will benefit most from its use, and are of course pleased to provide CMS with any additional information that it may find useful in reaching its final decision in this regard.

Sincerely,

/s/
Zaver Bhujwalla, Ph.D.
President, WMIS

/s/
Harvey L. Neiman, M.D., FACR
Chief Executive Officer, ACR

/s/
Frederic H. Fahey, D.Sc., FACR
President, SNMMI

/s/
Pamela W. Schaefer, M.D.
President, ASNR

/s/
Hossein Jadvar, M.D., Ph.D., M.P.H., M.B.A., FACNM
President, ACNM

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Thank you for the opportunity to comment on the proposed CMS decision memo to limit PET scan coverage to one scan after completion of anticancer therapy with subsequent scans determined by local Medicare Administrative Contractors.

I support lifting CED and ending NOPR data collection as the data clearly provided CMS with sufficient information to issue an NCD for oncologic indications. Ovarian cancer is but one indication where patients benefitted.

I oppose limiting subsequent scans, after anticancer therapy, to one scan. Regardless of the patient condition, stage or need, she/he would be limited to one scan, then local MACs will determine coverage. This scenario will result in varied coverage. Patients may be asked to sign an ABN, most if unable to pay, will opt not to have the scan. This was the situation prior to the NOPR study: patients securing short-term monthly installment loans, at a high rate of interest, more worried about the loan than scan results!

Please reconsider this decision memo as it is not beneficial to patients as currently proposed.

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April 9, 2013

To: Louis Jacques, MD
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services

Re: CAG#00181R4- Comments

Dear Dr. Jacques,

As a board-certified and practicing medical oncologist with an academic specialty practice focused on the management of the lymphomas, I was distressed to read the proposed decision memorandum for Positron Emission Tomography scans in patients with solid tumors. lndiscriminant application of the proposed rule in lymphoma will adversely influence clinical outcomes, and unnecessarily stifle clinical advancements in these diseases. Currently the proposed rule will allow a single baseline study and a single subsequent study, which will be inadequate to fully use this diagnostic modality. PET imaging offers opportunities to improve accuracy of histologic diagnosis, reduce long-term toxicities associated with excess chemotherapy exposure, and the potential to reduce overall healthcare costs through reduced utilization of certain biologic agents.

Except for the slow growing non-Hodgkin lymphoma, most lymphoproliferative disorders are uniformly PET avid.¹ PET thus has a well defined role in appropriate staging of patients with a new diagnosis of lymphoma, both upstaging patients with foci of disease not seen on computed tomography scan and downstaging those with soft-tissue masses that do not represent lymphoma.² The proposed ruling will allow for baseline scans for staging, but the point here is that this is a one of two allowed PET scans that will be done in nearly every patient.

The next PET scan that is performed in nearly all lymphoma patients is an interim restaging scan after two or three cycles of chemotherapy. The evidence supporting this approach is best in Hodgkin lymphoma, where a negative PET scan after two cycles is associated with an excellent disease free survival and a positive scan is suggestive of disease that will progress despite treatment.³ Subsequent studies have suggested improved outcomes associated with treatment intensification based on interim PET scan,⁴ and 14 trials are currently underway worldwide to validate this approach of response adaptive therapy.⁵ Thus, a baseline PET and interim restaging PET is rapidly becoming standard of care for these patients. Based on the current proposed ruling, that would be all the PET scans allowed for a year for these patients. However, for the patient who had a positive interim PET, there will be no mechanism to confirm that the intensified chemotherapy actually did address the residual PET avid disease, as there would be no end of treatment PET scan allowed.

Another critical scenario where additional PET scans would be of value is in the setting of suspected early disease relapse, particularly for patients with low-grade lymphomas. A minority of patients with low-grade lymphomas will transform into a high grade lymphoma.⁶ Definitive diagnosis of transformation frequently requires an invasive biopsy procedure. PET scan has proven useful in guiding not only the performance of a biopsy but also in choosing the most appropriate biopsy site.⁷ High PET uptake in relapsed disease is suggestive of histologic transformation of disease. For patients with indolent lymphoma who were treated within one year, this information would then become unavailable. A baseline PET for indolent lymphoma is necessary to adequately stage the disease, and an end of treatment PET is rapidly becoming standard as it provides prognostic information⁸ and may inform the choice of maintenance or consolidation therapy after induction chemotherapy.

While this letter could go on with more scenarios in which additional PET scans after the baseline and interim are tremendously helpful in the management of patients with lymphoma, the point here is that the broad application of this proposed rule does not take into consideration the nuances of care of patients with lymphoma. The uniform application of the rule as proposed will diminish the quality of care for many patients with lymphoma. While some rules will be necessary to control the excessive use of PET in cancer patients in general, one set of rules for all diseases ignores a number of ways that PET can specifically assist in the management of lymphoma patients. I hope that the blunt nature of this proposed ruling will be reconsidered.

Sincerely,

Kenneth Carson,
Assistant Professor of Medicine

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The proposed one-scan limitation for subsequent patient management is not medically appropriate. (For instance, the prevailing standard of care for some indications requires more than one subsequent patient management scan, and limiting FDG PET may simply incentivize the increased use of CT).

This will make a huge negative impact on the way cancer patients are being managed currently. Physicians use FDG PET to evaluate response to therapy, both after chemotherapy and sometimes during so that a change in therapy can be made if the patient does not appear to be responding. For example, lymphoma patients often require several scans per year to determine relapse or recurrence. You will be limiting these patients access to necessary medical care. Innumerable studies throughout the medical literature have proven the increased accuracy of diagnosis by FDG PET and resultant change in management in a significant number of patients. The proposed non-coverage of FDG PET for prostate cancer is not warranted, given the demonstrated benefits of FDG PET for patients with advanced castrate-resistant disease, and the fact that beneficiary access to C-11 choline is currently limited to Mayo Clinic-Rochester patients. CMS is ignoring the below NOPR data that demonstrates a reported change in clinical management >35% in over 10,000 patients.

Additionally, requiring local MACs to process additional scans requests would only create significant administrative complications. (For instance, the likelihood of disparate local coverage standards, the burden on treating physicians, and the possible need to collect ABN forms from beneficiaries during the course of treatment.)

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Over the past several decades, PET has become an indispensable tool in the assessment and follow-up of cancer patients. Although cancer is a widely varied disease and FDGPET does not perform uniformly in every type of cancer, neither do other imaging modalities, such as CT or MRI. If this critical tool is no longer available for appropriate use, then the physicians caring for cancer patients will be forced to order an ever increasing number of additional tests and/or even more costly invasive procedures including biopsies, lung resections, in order to answer these clinical questions. Much worse, without the ability to assess early treatment response or to establish new baselines of tumor burden before and/or after second-line or third-line therapies, these unfortunate patients will be subjected toexpensive and toxic therapies that may have been avoided by appropriate use of PET.

FDG-PET overage for subsequent treatment strategy should not be limited to ONE scan, with additional scans left up to determination by the local Medicare Administrative Contractors. Patients with many malignancies benefit from FDG-PET at initial staging and at multiple times for subsequent treatment strategy.

a. If the approved subsequent FDG-PET demonstrates active disease, requiring a change in therapy, the patient may well need follow-up evaluation with FDG-PET to assess response to second-line therapy.
b. After initial response, if there is subsequent suspicion of recurrence/progression, another FDG-PET scan is often indicated.
c. Cancer patients may go through several variations of “response-progressionremission-recurrence” during the course of their disease.
d. For these reasons, current guidelines for managing patients with various malignancies recommend multiple FDG-PETs for subsequent treatment strategy over the course of their disease.

2. Requiring tumor-by-tumor or case-by-case approval by the local Medicare Administrative Contractors for additional scans will pose an unnecessary burden on everyone involved.

a. Referring physicians will have to navigate through potential maze of variable coverages for different tumors or a preapproval process to order a PET study that has been thoroughly demonstrated in the literature to be a safe and effective examination for subsequent treatment planning.
b. Seriously ill patients will have to suffer through uncertainties regarding whether their scans will be approved, difficult decisions regarding ABNs and possible selfpay, and potentially dangerous delays in care. The increased bureaucracy imposed on the MACs will increase administrative costs and could foster pre-approval backlogs for both PET patients and patients being evaluated for other diagnostic or therapeutic modalities.

3. If CMS is convinced that more rigid guidelines for post-treatment scans are absolutely necessary, then a better approach would be to nationally cover PET for these indications without restriction, but allow MACs to place reasonable frequency limitations on the use of PET in the post -treatment period. While this is not ideal, it is a far better solution that what CMS has proposed.

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Please reconsider your proposal to limit the number of Pet CTs that a patient with cancer may have. Pet is a very useful tool to evaluate for progressive disease. For example for men with Prostate cancer or Women with bony metastases with breast cancer, bone scans diffusely light up when the bone is involved but the uptake doesn't stop if the cancer in the area has responded to disease. Pet can show old burned out areas of disease and new growth in previously treated areas There are no other good ways to be sure of this, and we don't want to risk continuing a useless treatment or abandoning an effective treatment. Also I have had patients with liver metastases who's masses did not appreciably shrink on CT but stopped taking up FDG. Pet is the only means to follow those patients. It allowed me to take people off treatment for a "drug holiday" despite very alarming looking CT scans. Pet scans with CTs should be allowed when medical decision making depends on the result. If a Pet is used without plans for a change of therapy based on the outcome, then the pet is not necessary and should be denied. Medicare is required to cover medically necessary interventions.

In addition, when clinical care is limited by an arbitrary number, the next patient is likely to be on the other side of that number. CMS should not be able to arbitrarily limit the number of time a patient goes to the Emergency department or is admitted to an ICU. Imaging should not be any different.

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CMS is proposing to provide coverage for the subsequent treatment strategy evaluation (which includes use of PET for treatment monitoring, restaging and detecting suspected recurrent disease) for all cancers, except for prostate cancer. However, CMS proposes to limit the number of PET studies for subsequent treatment strategy evaluation to a single scan and proposes potentially severe roadblocks for reimbursing additional scans.

While the proposed coverage decision represents progress in the care of some cancer patients (the ones in which only a baseline scan was thus far covered without the NOPR data collection requirements), it would severely undermine the management of many other patients.

The proposed coverage document acknowledges the role of FDG-PET for therapy response assessments. However, CMS has ignored the emergence of multiple lines of treatments that are now available for many cancers. It is, in our view, not rational to acknowledge the role of PET for initially identifying treatment responders vs. non-responders but to deny patients the same modality for subsequent lines of therapy if these are available and reasonably effective.

CMS is certainly aware of a fairly recent analysis that reported the utilization of imaging modalities during the first 2 years after cancer diagnosis (Dinan et al, JAMA 2010). This analysis revealed that patients with colorectal cancer, breast cancer, leukemia, lung cancer and non-Hodgkin Lymphoma receive on average 0.3, 0.2, 1.0 and 1.1 PET scans, respectively during the first 2 years after diagnosis. The corresponding numbers for CT are 5, 2, 3, 6 and 6 CT scans during this time frame, respectively. In contrast to the extensive PET data provided by NOPR, no such data are available for CT. In fact, for many cancers for which multiple lines of treatments are administered, assessments of glucose metabolism and its changes by FDG-PET are much more predictive for response or non-response than anatomical CT assessments. This is important because initial cancer therapies can be of limited effectiveness. Recognizing such treatment failures early during the course of therapy is critically important for optimized and individualized patient care.

This has been acknowledged in guidelines by many professional organizations such as for instance lymphoma working groups. Our group has recently shown in sarcoma patients that PET, but not CT identifies non-responders and responders after a single cycle of combined chemo-radiation therapy and that response is associated with patient outcome (Herrmann et al; Clinical Cancer Research 2012). A study in patients with non-small cell lung cancer demonstrated that FDG PET identifies responders and non-responders after only 2 weeks of treatment with erlotinib (Benz et al; JNM 2012). It is important to note that non-responders will undergo alternative treatments, which again requires accurate response assessments that are best done with PET. There are numerous other studies demonstrating the same unique ability of PET to identify responders and non-responders early after start of treatment. The literature evidence in support of FDG-PET for treatment response assessments to cytotoxic and targeted therapies is extensive, robust and beyond the scope of this comment (reviewed by Weber WA, J Nucl Med 2009; Czernin et al; European Journal of Radiology 2010).

In summary, based on the unparalleled evidence provided by NOPR (no comparable evidence available for any other diagnostic modality) and based on the large number of prospective studies in patients with a wide range of cancers, we request that coverage for subsequent treatment strategies should be unrestricted to include all patients in whom treatment decisions are required at any stage of their disease. The coverage decision cannot be left up to local Medicare Administrative Contractors since this approach is simply not manageable in a sufficiently efficient manner to ascertain the best and promptest care of cancer patients. What makes the current CMS proposal unique is that it reverses prior coverage decisions without any data in support of this change.

As practicing medical, surgical, gynecological and radiation oncologists and imaging specialists, we know best when we need FDG-PET, CT and MRI to provide the best care for our patients. The CMS data provided by Dinan et al (JAMA 2010) underscores that PET is used judiciously and in fact, infrequently. It therefore does not make sense for CMS to decide which diagnostic tools we use in the care of cancer patients.

Judith Gasson, Ph.D.
Professor of Medicine and Biological Chemistry
Director, Jonsson Comprehensive Cancer Center
President, Jonsson Cancer Center Foundation
Senior Associate Dean for Research
David Geffen School of Medicine

Johannes Czernin, M.D.
Professor and Vice Chair
Molecular and Medical Pharmacology
Chief, Ahmanson Translational Imaging Division
David Geffen School of Medicine at UCLA

James Economou, M.D., Ph.D.
Vice Chancellor for Research
Chief, Division Surgical Oncology
Professor, Departments of Surgery, Microbiology, Immunology and Molecular Genetics, and Molecular and Medical Pharmacology
David Geffen School of Medicine at UCLA

Steven M. Dubinett, M.D.
Chief, Division of Pulmonary and Critical Care Medicine
Associate Vice Chancellor for Research
Senior Associate Dean, Translational Research
Director, Clinical and Translational Science Institute
David Geffen School of Medicine at UCLA
University of California, Los Angeles

Michael Steinberg, M.D.
Professor and Chair
Department of Radiation Oncology
David Geffen School of Medicine at UCLA

Alan Fogelman, M.D., Ph.D.
Professor and Chair
Department of Medicine
Director of the Atherosclerosis Research Unit
Castera Professor of Cardiology
David Geffen School of Medicine at UCLA

Ron Busuttil, M.D., Ph.D.
Professor and Chair
Department of Surgery
Director and Chief, Dumont-UCLA Liver Cancer Center
Chief, Liver and Pancreas Transplantation
David Geffen School of Medicine at UCLA

Gautam Chauduri, M.D., Ph.D.
Professor and Chair
Department of Obstetrics and Gynecology
David Geffen School of Medicine at UCLA

Robin Farias-Eisner, M.D., Ph.D.
Professor and Chief
Department of Obstetrics and Gynecology
Director, Center for Biomarker Discovery and Research
David Geffen School of Medicine at UCLA

John Glaspy, M.D., M.P.H.
Professor, Department of Medicine, Hematology/Oncology
Estelle, Abe and Marjorie Sanders Endowed Chair in Cancer Research
Vice-Chair for UCLA's Jonsson Comprehensive Cancer Center Scientific Protocol Review Committee
David Geffen School of Medicine at UCLA

Timothy Cloughesy, M.D
Professor, Clinical Neurology
Director, Department of Neurology, Neurological Services, Neuro-Oncology Program
David Geffen School of Medicine at UCLA

Helena Chang, M.D.
Professor, Department of Surgery
Director, Revlon/UCLA Breast Center
David Geffen School of Medicine at UCLA

Timothy Donahue, M.D.
Assistant Professor
Departments of Surgery, Division of Surgical Oncology, Molecular and Medical Pharmacology
David Geffen School of Medicine at UCLA

Fritz Eilber, M.D.
Associate Professor of Surgery
Director, Sarcoma Program
David Geffen School of Medicine at UCLA

Sven de Vos, M.D., Ph.D.
Associate Professor, Department of Medicine, Hematology/Oncology
Director, Jonsson Comprehensive Cancer Center, Data Safety Monitoring Board Shared Resource
David Geffen School of Medicine at UCLA

Zev Wainberg, M.D., M.Sc.
Assistant Professor, Department of Medicine, Hematology/Oncology
David Geffen School of Medicine at UCLA

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ATTN: Comment below is personal, not an official organization position.

Thank you for the opportunity to comment on the proposed CMS decision memo to limit PET scan coverage to one scan after completion of anticancer therapy with subsequent scans determined by local Medicare Administrative Contractors.

I support lifting CED and ending NOPR data collection as the data clearly provided CMS with sufficient information to issue an NCD for oncologic indications. Ovarian cancer is but one indication where patients benefitted.

I oppose limiting subsequent scans, after anticancer therapy, to one scan. Regardless of the patient condition, stage or need, she/he would be limited to one scan, then local MACs will determine coverage. This scenario will result in varied coverage. Patients may be asked to sign an ABN, most if unable to pay, will opt not to have the scan. This was the situation prior to the NOPR study: patients securing short-term monthly installment loans, at a high rate of interest, more worried about the loan than scan results!

Please reconsider this decision memo as it is not beneficial to patients as currently proposed.

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On behalf of the PET Facility in the Department of Nuclear Medicine at The University of Texas, MD Anderson Cancer Center in Houston we are writing to reaffirm our strong support of expanding the National Coverage Decision (NCD) for PET in response to the request stemming from the coverage with evidence development program for solid tumors for subsequent treatment strategy. We are a large American College of Radiology (ACR) accredited PET imaging facility for oncology. In addition, we maintain qualification as a National Cancer Institute (NCI) PET Center for Quantitative Imaging Excellence (CQIE). Many of our clinical and imaging physicians work with colleagues from other institutions to develop guidelines for appropriate use of FDG-PET/CT, through the National Cancer Care Network (NCCN) and ACR.

In the proposed Decision Memo for Positron Emission Tomography (FDG) for solid tumors (CAG-00181R4), CMS determined that ONE FDG-PET study would be covered in the subsequent anti-tumor treatment strategy setting, and that coverage of any further scans to guide therapy would be determined by the local Medicare Administrative Contractors. We are concerned that this proposal is overly restrictive, and will serve as a barrier to the appropriate utilization of FDG-PET by physicians as they care for the patient with cancer.

The concept of quality and appropriate resource utilization in cancer care is quite different than in other areas of medicine, in that for most cancer patients only a small fraction of their care is received during an acute hospital admission. Cancer care is best described as a series of care episodes, occurring over the lifetime of a patient. This is in contrast to the typical acute-care events such as acute cardiac event or pneumonia, in which resource utilization is easily tracked and outcomes are easily defined as a single care event. For the cancer patient, such measures can only be realistically applied when each cycle of the patients care is defined and assessed individually. This concept is outlined in a white paper by the National Quality Forum titled “Towards a Comprehensive Cancer Measure Set: Value-Based Episodes of Care.” In it, the working group of the NQF states the following: “… we believe that in most cases it is possible to delineate different episodes of treatment within a particular patient’s cancer experience. Within each episode, coordination is needed, and quality in terms of process, structure, and in some cases outcome could be measured.”

We see this concept applied on a daily basis at MD Anderson Cancer Center. Many of our patients come to the institution with advanced and refractory disease, seeking the cure that has eluded them thus far. We rely on our multidisciplinary care teams, comprised of medical oncologists, surgeons, radiation oncologists, imaging specialists, ancillary service providers, and others to decide upon the necessary and appropriate workup and management of patients during each episode of their care. For example, a patient with refractory lymphoma, previously evaluated with FDG-PET at initial staging and subsequent to first-line chemotherapy may well recur at a point in the future. The consideration of high-dose chemotherapy and autologous stem cell transplantation marks the transition into a new episode of cancer care, very different from the first. In this new episode, the patient may require a new “initial” FDG-PET followed by a second FDG-PET for subsequent treatment determination. Resistant disease may then be managed with external beam radiation therapy, again marking the transition to a new episode of care. Each episode is quite distinct in its therapeutic approach, resource utilization, and outcomes measures.

We respectfully request that CMS reevaluate this proposed Decision Memo with this concept of Cancer Care Episodes in mind, and consider removing the language restricting patients to a single FDG-PET in the subsequent treatment strategy setting. In support of our assertion regarding the utility of FDG-PET in the care of the cancer patient beyond the first episode of care (i.e. a single initial FDG-PET and a single subsequent FDG-PET as proposed in CAG-00181R4), we supply the following peer-reviewed articles authored by MD Anderson physicians, illustrating the impact of FDG-PET on the management of patients in subsequent cancer care episodes. We have focused on those malignancies which previously had no restriction on number and frequency, and for which the proposed decision therefore marks a significant change in policy by CMS.

Respectfully Submitted,

Eric M. Rohren, M.D., Ph.D., Section Chief, PET
Nancy M. Swanston, Admin Director, Division of Diagnostic Imaging
Homer A. Macapinlac, M.D., Chair, Department of Nuclear Medicine

REFERENCES

Breast Cancer

Esophageal Cancer

Lymphoma

Melanoma

Non-Small Cell Lung Cancer

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April 5, 2013

To: The Centers for Medicare & Medicaid Services (CMS)

RE: Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors - Public Comment

To Whom It May Concern:

This letter is in regards to the recent CMS proposal pertaining to the clinical use of Position Emission Tomography (PET). The University of Wisconsin- Division of Otolaryngology Head and Neck Surgeons strongly urge you to reconsider this proposal.

The standard of care to date has been to order CT - PET imaging three-months post treatment completion and when there are concerns for cancer recurrence. This has proven to be invaluable in identifying recurrent disease and allowing prompt treatment which would have otherwise been delayed. CT - PET is also useful in cases where a negative PET study eliminates the need for other investigations including endoscopy and biopsy under general anesthesia. If Medicare makes a decision not to cover CT - PET imaging, this will have a significant negative impact on our head and neck cancer population at the University of Wisconsin - Madison.

Please take this information into consideration when reviewing the current proposal on PET scan coverage.

If you would like to discuss this further, please do not hesitate to contact us at 608 263 0192.

Sincerely,

Tim McCulloch, MD
Professor and Chairman
Otolaryngology Head & Neck Surgery

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I applaud the expansion of coverage for PET to include a broader range of malignancies. It's utilization in surveillance has been of questionable benefit, but it's role in evaluation for suspected recurrence or progression of existing disease has been quite valuable. As a board certified medical oncologist and cancer liaison physician for the ACS, I have encountered numerous instances where the information obtained from a PET scan has been able to delineate treatment decisions to avoid giving further expensive chemotherapy agents or avoid further diagnostic tests. My patients have benefitted financially and from the prevention of potentially morbid procedures.

In our state, one of the insurers uses a third party advisory board (TPAB) which uses predefined measures of what they believe is necessary for a PET - this would be similar to the Medicare Advisory Contractor. TPAB has been quite obstructive in trying to apply best medical advice to our patients considering that 95% are approved after a delay to get the test. This creates quite a bit of anxiety to the patient and frustration with the insurance company. If the MAC is utilized, there will be undue administrative burdens and costs to everyone involved.

Managing patients with incurable cancer is frought with chemotherapy administration, the anxiety of waiting for the results of CT/PET scans. If a patient has responded, then performing follow up scans is performed to determine when a next line of chemotherapy should be administered or whether chemotherapy should be administered at all. Limitations on PET scans would be quite difficult to manage certain cancer patients and the type of scan should be determined by a qualified medical professional who is actually laying hands on a patient.

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First, I want to thank CMS for appropriately broadening the coverage for specific tumors, especially in my practice that contains many patients who will benefit (brain, cervical, pancreas, small cell lung, testicular, thyroid, etc.). From my perspective as a practicing oncology pharmacist, FDG-PET is a well-established cancer imaging method that should be available for use by treating physicians as they deem necessary for management of their patients with all types of cancer. PET has proved its value in my practice, not only in evaluating for residual or recurrent tumor after the completion of first-line therapy, but also in assessing treatment efficacy, in saving money and toxicity by allowing early changes from ineffective therapies to more effective therapies, and by assessing for suspected recurrence.Over the past several decades, PET has become an indispensable tool in the assessment and follow-up of cancer patients. Although cancer is a widely varied disease and FDG-PET does not perform uniformly in every type of cancer, neither do other imaging modalities, such as CT or MRI. If this critical tool is no longer available for appropriate use, then the physicians caring for cancer patients will be forced to order an ever-increasing number of additional tests and/or even more costly invasive procedures, in order to answer these clinical questions. I also would like to support the option to use PET imaging in certain patients with prostate cancer. I understand that prostate cancer is a heterogeneous disease and that the use of PET should be limited to a small subset of patients, but prostate cancer should be covered in the same manner as all other cancers, and the decision to perform FDG PET/CT should be the decision of the treating physicians. Limiting this life-saving procedure is an undue stress that cancer patients should not have to face in their treament or recovery . I want to thank you for your time and opportunity to express my opinions on this very important issue.

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It has been a pleasure working with CMS for the last several years in terms of obtaining PET imaging for cancer patients insured by your Service. In fact, I have bragged to non-CMS patients that their insurance companies are not nearly as enlightened when it comes to letting oncologists be oncologists by allowing me to utilize the wonderful tool called PET imaging.

Any move to restrict PET imaging for staging and guiding treatment related decisions would be a serious step backwards for cancer patients and health care professionals. I understand that routine serial PET imaging just to "comfort" patients can become abusive, but not the PET imaging we use everyday to guide decision making and therapy decisions. Please do not restrict that use of PET imaging.

The PET image gives me early warning of either positive effect, or negative effect, and can actually save time, money and radiation to the patient. I can most often make all the decisions I need with a PET scan, that might take several lesser scans to achieve the same result. Not to mention, for the patient with poor kidney function, the PET is much safer overall, and less contrast dye injected.

I emplore you to allow PET imaging, FDG and NaF, both for staging cancer, and to monitor result of therapy. Any efforts to discourage routine, and serial scanning for comfort's sake, I can understand and live with.

Sincerely,

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I am a physician at a major Academic Medical Center in the United States, specializing in the use of nuclear medicine and FDG PET for management of patients with cancer. I would like to comment on the CMS Proposed Decision Memo for PET (FDG) for Solid Tumors (CAG-00181R4).

Cancer is a chronic disease. Cancer is the second leading cause of death in the United States, exceeded only by heart disease. In 2008, more than 565,000 people died of cancer, and more than 1.48 million people had a diagnosis of cancer, according to the United States Cancer Statistics: 1999–2008 Incidence and Mortality Web-based Report.

Cancer along with diabetes and heart disease (which has been converted to a chronic disease over the last 30 years) is one of the leading causes of death and disability in the United States. Chronic diseases account for 70% of all deaths in the U.S., which is 1.7 million each year. These diseases also cause major limitations in daily living for almost 1 out of 10 Americans or about 25 million people.

Cancer is not a one-time event. Cancer can come back a second and third time and often becomes a chronic illness. It is important to know that even those who are not cured of cancer may go on living for months or years, even though there may be changes in their lives. And though it can be hard to do, many families adjust to this kind of repetitive treatment schedule. For these people, cancer can be much like diabetes or heart disease – a chronic illness that is mostly controlled with repetitive treatment.

It is for these reasons that the CMS proposal that one FDG PET scan be covered when used to guide subsequent physician management of anti-tumor treatment strategy after completion of “initial anticancer therapy” (although CMS does not define the scope of that term) is unacceptable. The proposed one-scan limitation for subsequent patient management is not medically appropriate, will result in poor management, poor outcomes and likely no costs savings as this limitation will surely increase the use of other imaging modalities such as CT and MRI when physicians seek information about whether this chronic disease is stable, progressing or has responded to interim treatment.
Rather I would suggest that CMS replace the proposed one-scan limit for subsequent patient management with national coverage, subject to local MAC discretion to impose frequency limitations as medically reasonable. This approach would balance medical necessity for beneficiaries with the understandable desire of CMS to curtail the use of FDG PET.

I would also suggest that the proposed non-coverage of FDG PET for prostate cancer is not warranted, given the demonstrated benefits of FDG PET for patients with advanced castrate-resistant disease, and the fact that beneficiary access to C-11 choline is currently limited to only Mayo Clinic-Rochester patients.

Finally, there is confusion in my community about the phrase “After Completion of Initial Anticancer Therapy” that is used in the Proposal. The scope of this phrase needs to be defined and CMS should be encouraged to clarify that treatment monitoring performed during “initial anticancer therapy” would continue to be covered (e.g. at the midway point in a multi-cycle chemotherapy regimen.)

I have observed on many occasions that this practice is often a critical step in determining appropriate management of the patient’s cancer providing unique, early information that is not available through other diagnostic interventions.

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To whom it may concern:

CMS is proposing to provide coverage for the subsequent treatment strategy evaluation for all cancers, except for prostate cancer. However, CMS proposes to limit the number of PET studies for subsequent treatment strategy evaluation to a single scan and proposes potentially severe roadblocks for reimbursing additional scans.

While the proposed coverage decision represents progress in the care of some cancer patients, it would severely undermine the management of many other patients. The proposed coverage document acknowledges the role of FDG-PET for therapy response assessments. However, CMS has ignored the emergence of multiple lines of treatments that are now available for many cancers. It is, in our view, not rational to acknowledge the role of PET for initially identifying treatment responders versus non-responders but to deny patients the same modality for subsequent lines of therapy if these are available and reasonably effective.

Based on the unparalleled evidence provided by NOPR and based on the large number of prospective studies in patients with a wide range of cancers, we request that coverage for subsequent treatment strategies should be unrestricted to include all patients in whom treatment decisions are required at any stage of their disease.

The coverage decision cannot be left up to local Medicare Administrative Contractors since this approach is simply not manageable in a sufficiently efficient manner to ascertain the best and promptest care of cancer patients. What makes the current CMS proposal unique is that it reverses prior coverage decisions without any data in support of this change.

As practicing thoracic medical oncologists, I know best when we need FDG-PET, CT and MRI to provide the best care for our patients. The CMS data provided by Dinan et al (JAMA 2010) underscores that PET is used judiciously and in fact, infrequently. It therefore does not make sense for CMS to decide which diagnostic tools we use in the care of cancer patients.

Sincerely,

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I am submitting this comment on behalf of the Nuclear Medicine/PET section from Vanderbilt University Medical Center. We understand that CMS is proposing to end the data collection requirements under the National Oncologic PET Registry (NOPR) and to expand FDG-PET and PET/CT coverage for the subsequent treatment strategy evaluation (including treatment monitoring, restaging and detection of suspected recurrence) for all cancers, except for prostate cancer.
The following are our comments about the proposed coverage decision:

1. We are grateful that patients with all solid tumors (except prostate cancer) will have PET coverage for subsequent treatment strategy evaluations without the continuing burden of NOPR data collection for many of these cancers. FDG-PET is extremely helpful to us in making management decisions in these patients with proven cancers undergoing therapy and in assessing for residual or recurrent disease after completion of therapy. The utility of FDG-PET in virtually all malignant neoplasms is documented by a large amount of peer-reviewed literature and by the data obtained by the NOPR.
2. However, FDG-PET coverage for subsequent treatment strategy SHOULD NOT BE LIMITED TO ONE SCAN, with coverage for additional scans at the discretion of local Medicare Administrative Contractors. Rather we strongly recommend that all cancers should have coverage for subsequent treatment strategy evaluations the same as that now provided for non-small cell lung, head and neck, esophageal, colorectal, breast, cervical and ovarian cancers, as well as melanoma, lymphoma, and myeloma. We make this recommendation with the understanding that the Medicare Administrative Contractors retain the prerogative they have now to impose frequency limits, where appropriate. Patients with many malignancies benefit from FDG-PET at initial treatment strategy evaluation and at multiple time points for subsequent treatment strategy evaluations. Patients with cancer now live longer in part because more treatment options are now available, and their cancers often need to be treated over the course of many years. How to rationally make treatment decisions over the course of a patient’s illness depends on assessments of disease activity and response to varying therapies. This is especially important since many of the newer therapeutic options are very expensive; optimal use of such therapies is in patients who are benefitting.
   1. Vanderbilt is a referral center and treat cancer patient when first diagnosed but also patients that are referred because they became resistant to standard therapies or because they have uncommon malignancies. These patients are often referred for more than one PET/CT scan for restaging.
   2. Vanderbilt is an institution member of the National Comprehensive Cancer Network (NCCN). The NCCN, a multispecialty organization, and other similar organizations develop guidance for many types of cancers. Their guidelines generated by panels of experts are better than what local Medicare Administrative Contractors (MACs) will do, which is likely to be very non-uniform across country. For example, NCCN’s guidelines for managing patients with malignancies recommend multiple FDG PET/CTs for subsequent treatment strategy for many cancers over the course of their disease.
   3. Leaving the decision up to the local MACs is an unnecessary burden for treating physicians and who have to go through the pre-approval process.
   4. Leaving the decision up to the local MACs is an unnecessary burden for patients. Although, preapproval is only required for patients in Medicare Advantage plans, PET facilities, in the absence of clear, published Local Coverage Policies (LCPs) will not know whether any subsequent treatment strategy scan is covered, and thus to ensure payment will have to ask patients for Advance Beneficiary Notice (ABN). This is burden for PET facilities, but more important, many patients who need PET will decline signing the ABN because they won’t or can’t bear the financial consequences of signing ABN.
3. Prostate cancer is a heterogenous disease as are all cancers. The value of FDG- PET has been demonstrated in small subsets of patients, particularly those with advanced castrate-resistant disease. Although we agree that, as CMS noted, there is now considerable interest in other tracers, such as C-11 choline, for imaging of prostate cancer, the vast majority of Medicare beneficiaries have no access to PET with these other tracers, which are not yet FDA approved or approved at only a single city in the United States. FDG-PET in prostate cancer should be covered along with the proposed coverage for all other cancers. It certainly should not be nationally non-covered. The decision to perform FDG-PET to address specific management questions in patients with prostate cancer should be left to treating physicians. Again, we recognize that the Medicare Administrative Contractors would retain the authority to define in their Local Coverage Policies those ICD-9 codes (or combinations thereof) that indicate medical necessity.
4. Finally, we wish to emphasize from our perspective as practicing physicians 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. We acknowledge that FDG-PET does not perform uniformly in every type of cancer, but neither do CT nor MRI—it no longer makes sense for CMS to micromanage physician use of this important cancer diagnostic tool.

Dominique Delbeke, MD, PhD
Professor and Director of Nuclear Medicine and PET
Department of Radiology and Radiological Sciences
Vanderbilt University Medical Center
21st and Garland Avenue
Nashville, Tennessee 37232
Ph: 615-343 8516
FAX: 615-343 6531

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It is not reasonable to guarantee only one PET for subsequent treatment strategy under the NDC and hope the MAC's will approve the proper number of scans locally. What happens if a MAC does not approve additional PET's. PET is invaluable in the management of so many forms of cancer. Not having it available will put patients' lives and health at risk.

In addation to the PET after the completion of therapy, it has become common to order a PET during chemotherapy as research has shown that to be the most effective means of getting an "early read" on the effectiveness of the treatment. This is a very cost effective utilization as ineffective chemotherapy agents can be stopped or changed. CMS approved reimbursement for this concept of therapy years ago for Breast Cancer, and it has recently been approved for all 11 cancers for which Subsequent Treatment Strategy PET's are approved. Your proposal does not allow for this at all.

And PET looking for a possible recurrence later on is also invaluable. Frequently PET is able to identify sites of recurrence long before other imaging modalities. Not having this additional "subsequent" PET will delay treatment, thereby increasing costs, and decreasing health outcomes.

Finally, leaving the decision up to the MAC's will result in differing standards regionally. Cancer patients' lives and health, as it relates to PET, will be at the mercy of the region of they country in which they live. General research has studied how health outcomes differ by various factors, including race, income, and geographic location. This decision will only make the variation in health outcomes for cancer patient by location worse.
Also consider the initial confusion as the proposed policy takes effect. It will be difficult for the MAC's to effectively communicate their new policies to all physicians wo need to know. Many Oncologists will almost certainly not know whether a given "subseqent" PET will be covered or not so they will simply will not order it - again, placing the patient at risk.

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I have reviewed the new guidelines for the use of PET imaging for solid tumors and have some concerns with these recommendations. I am a pediatric, adolescent, and young adult oncologist and manage the care of many individuals with sarcomas, particularly rhabdomyosarcoma, osteosarcoma, and Ewing sarcoma. There is a convincing body of literature that demonstrates that PET response correlates with treatment efficacy and is a valuable tool to determine the effect of neoadjuvant chemotherapy in these highly malignant tumors. Limiting PET scans at diagnosis only would affect our ability to tailor treatments to the individual patient and I strongly recommend that CMS amends these recommendations to allow for a more liberal use of PET scanning in the treatment of sarcomas.

Sincerely,

Scott Borinstein

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As a PET center director at one of the NCCN member institutions, I'm excited about the coverage changes for the PET. The end of coverage with evidence development (CED) will benefit many patients and increase the access for others. Accurate staging of the cancer patients could decrease the cost of care eventually.

However, one PET scan only for subsequent treatment strategy might not be enough for many patients. There are articles to demonstrate the utility of PET to follow-up treatment response both early and late. The early scans are useful to decide the course of action, and late scans might be for confirmation of therapy effects. We respectfully request to reconsider the policy before it finalized.

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The Dana-Farber Cancer Institute Department of Imaging did a quick analysis of our FDG-PET/CT scan stats over the last few years. Of a total of 27,732 scans, the results show that an average of 2.1 scans were performed per patient with a range of 1-31/patient. Of note, keep in mind that approximately half of these patients may have come to the Dana-Farber with a PET/CT already performed on the outside, so that our “baseline” scan actually may represent the first follow-up.

These cancer center data show that our clinicians are not currently overusing PET/CT in patients based on the current CMS design of initial/subsequent treatment strategy. There is, therefore, no apparent reason to modify the current reimbursement template in our cancer center practice since our clinicians most often do not order more than two scans per patient. We should still allow clinicians to order a scan when they see fit since most of the patients getting more than 2 scans are a minority in whom those scans are performed due to a particular problem-solving situation that is clinically relevant.

Annick D. Van den Abbeele, MD, FACR
Chief, Department of Imaging, Dana-Farber Cancer Institute
Founding Director, Center for Biomedical Imaging in Oncology, Dana-Farber Cancer Institute
Co-Director, Tumor Imaging Metrics Core, Dana-Farber/Harvard Cancer Center

Heather Jacene, MD
Clinical Director, Nuclear Medicine
Dana-Farber Cancer Institute

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[PHI Redacted] Ovarian cancer often recurs not as solid tumors but as scattered "seeding" which then develops into small tumors, which is then much more advanced. CT often does not detect those types of disease patterns but PET does.

The wording of this draft proposal is difficult to decipher: would a patient with ovarian cancer have to wait till recurrence is very advanced before the proper type of diagnostic work can be done? What is the goal of throwing the decision to the local level??

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I understand that CMS is proposing to end the data collection requirements under the National Oncologic PET Registry (NOPR) and to expand FDG-PET and PET/CT coverage for the subsequent treatment strategy evaluation (including treatment monitoring, restaging and detection of suspected recurrence) for all cancers, except for prostate cancer. The following are my comments about the proposed coverage decision:

1. We in the Department of Vanderbilt University Medical Center, Nashville, TN, are pleased that patients with all solid tumors other than prostate cancer will have PET coverage for subsequent treatment strategy evaluations without the continuing burden of NOPR data collection. FDG-PET is extremely helpful to us in making management recommendations in these patients with proven cancers undergoing therapy and in assessing for residual or recurrent disease after completion of therapy. The utility of FDG-PET in virtually all malignant neoplasms is documented by a large amount of peer-reviewed literature and by the data obtained by the NOPR.

2. However, FDG-PET coverage for subsequent treatment strategy should not be limited to only one sPET examination, with coverage for additional scans at the discretion of local Medicare Administrative Contractors. Rather we strongly recommend that all cancers should have coverage for subsequent treatment strategy evaluations the same as that are now provided for non-small cell lung, head and neck, esophageal, colorectal, breast, cervical and ovarian cancers, as well as melanoma, lymphoma, and myeloma. We make this recommendation with the understanding that the Medicare Administrative Contractors retain the prerogative they have now to impose frequency limits, where appropriate. Patients with many malignancies benefit from FDG-PET at initial treatment strategy evaluation and at multiple time points for subsequent treatment strategy evaluations. Patients with cancer live longer now in part because more and better treatment options are increasingly available, and their cancers often need to be treated over the course of many years. How to rationally make treatment decisions over the course of a patient’s illness depends on assessments of disease activity and response to varying therapies. This is especially important since many of the newer therapeutic options are very expensive; optimal use of such therapies is in patients who are benefitting. For instance, biotherapy for GIST tumors often results in a marked depression if FDG activity without a corresponding reduction in tumor mass yet with improved outcome. Similar opportunities for assessment and treatment exist and will occur with thyroid cancers, prostate cancer, sarcomas, etc. Reducing the need for repeated biopsies in the assessment and reassessment strategies will benefit patients and will reduce costs, not to mention permit a change in therapy recommended.

1. The National Comprehensive Cancer Network (NCCN), a multispecialty organization, and other similar organizations develop guidance for many types of cancers. Their guidelines generated by panels of experts are well-respected nationally and internationally and likely are of higher quality than what local Medicare Administrative Contractors can accomplish; the resulting nonuniformity nationally creates conflicts for patients and medical care organizations, not to mention unecessary expense. For example, NCCN’s guidelines for managing patients with malignancies recommend multiple FDG PET/CTs for subsequent treatment strategy for many cancers over the course of their disease.

2. Leaving the decision up to the local Medicare Administrative Contractors is an unnecessary burden for treating physicians and who have to go through the pre-approval process.

3. Leaving the decision up to the local Medicare Administrative Contractors is an unnecessary burden for patients. Although, preapproval is only required for patients in Medicare Advantage plans, PET facilities, in the absence of clear, published Local Coverage Determination, will not know whether any Subsequent Treatment Strategy scan is covered, and thus to ensure payment will have to ask patients for Advance Beneficiary Notification. This is burden for PET facilities, but more importantly, many patients who need PET will decline, because they cannot accept the financial consequences of signing the Advance Beneficiary Notification . Dealyed treatment or the continuation of inappropriate treatment compromises patient care.

4. Prostate cancer is a heterogenous disease as are all cancers. The value of FDG- PET has been demonstrated in small subsets of patients, particularly those with advanced castrate-resistant disease. Although we agree that, as CMS noted, there is now considerable interest in other tracers, such as C-11 choline, for imaging of prostate cancer, the vast majority of Medicare beneficiaries have no access to PET with these short-lived tracers, which are not yet FDA approved or approved at only a single U.S. center. FDG-PET in prostate cancer should be covered along with the proposed coverage for all other cancers. It certainly should not be nationally non-covered. The decision to perform FDG-PET to address specific management questions in patients with prostate cancer should be left to treating physicians. Again, we recognize that the Medicare Administrative Contractors would retain the authority to define in their Local Coverage Policies those ICD-9 codes (or combinations thereof) that indicate medical necessity.

5. Finally, we wish to emphasize from our perspective 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. We acknowledge that FDG-PET does not perform uniformly in every type of cancesr, it no longer makes sense for CMS to micromanage physician use of this important cancer diagnostic tool. No other imaging modality nor therapy performs uniformly either.

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This comment is with regards to the recent CMS proposal that FDG PET for subsequent anti-tumor treatment strategy for beneficiaries with cancers of the prostate is not reasonable and necessary. I would like to note that several studies have provided evidence that indeed FDG PET is quite useful in the imaging evaluation of men with castrate resistant prostate cancer. These include assessment of the extent of metabolically active disease sites, treatment response evaluation, and prognostication. Please refer to the following references for background information. Based on the evidence provided in these peer-reviewed published articles, I strongly believe that CMS should include the use of FDG PET in the specific case of patients with castrate resistant metastatic prostate cancer.

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We understand that CMS is proposing to end the data collection requirements under the National Oncologic PET Registry (NOPR) and to expand FDG-PET and PET/CT coverage for the subsequent treatment strategy evaluation (including treatment monitoring, restaging and detection of suspected recurrence) for all cancers, except for prostate cancer.

The following are our comments about the proposed coverage decision:

1. We are grateful that patients with all solid tumors (except prostate cancer) will have PET coverage for subsequent treatment strategy evaluations without the continuing burden of NOPR data collection for many of these cancers. FDG-PET is extremely helpful to us in making management decisions in these patients with proven cancers undergoing therapy and in assessing for residual or recurrent disease after completion of therapy. The utility of FDG-PET in virtually all malignant neoplasms is documented by a large amount of peer-reviewed literature and by the data obtained by the NOPR.
2. However, FDG-PET coverage for subsequent treatment strategy should not be limited to ONE scan, with coverage for additional scans at the discretion of local Medicare Administrative Contractors. Rather we strongly recommend that all cancers should have coverage for subsequent treatment strategy evaluations the same as that now provided for non-small cell lung, head and neck, esophageal, colorectal, breast, cervical and ovarian cancers, as well as melanoma, lymphoma, and myeloma. We make this recommendation with the understanding that the Medicare Administrative Contractors retain the prerogative they have now to impose frequency limits, where appropriate. Patients with many malignancies benefit from FDG-PET at initial treatment strategy evaluation and at multiple time points for subsequent treatment strategy evaluations. Patients with cancer now live longer in part because more treatment options are now available, and their cancers often need to be treated over the course of many years. How to rationally make treatment decisions over the course of a patient’s illness depends on assessments of disease activity and response to varying therapies. This is especially important since many of the newer therapeutic options are very expensive; optimal use of such therapies is in patients who are benefitting.
   1. For example, I frequently see patients being assessed after a treatment cycle with stable findings on CT, but with clear-cut evidence of relapse or progression on PET, such as in patients with bone marrow metastases or with areas of relapse within previously quiescent sites of tumor. Likewise, I often see metastases that are outside the field of view of a CT of the chest, abdomen and pelvis but which are readily apparent on given the “whole-body” field of view of PET/CT. Additionally, I can often see disease response physiologically with PET/CT that is not visible on CT because the anatomic CT changes can take weeks or months to be apparent on CT. Finally, I can spot the one area of transformation in a low grade lymphoma to high grade disease, directing a single, high-yield biopsy, avoiding the “hit and miss” random biopsy results in patients who do not have their biopsies guided by physiology (e.g., guessing). All of these examples, and more, result in more cost-effective care and improved outcomes.
   2. The National Comprehensive Cancer Network (NCCN), a multispecialty organization, and other similar organizations develop guidance for many types of cancers. Their guidelines generated by panels of experts are better than what local Medicare Administrative Contractors can do, which is likely to be very non-uniform across country. For example, NCCN’s guidelines for managing patients with malignancies recommend multiple FDG PET/CTs for subsequent treatment strategy for many cancers over the course of their disease.
   3. Leaving the decision up to the local Medicare Administrative Contractors is an unnecessary burden for treating physicians and who have to go through the pre-approval process.
   4. Leaving the decision up to the local Medicare Administrative Contractors is an unnecessary burden for patients. Although, preapproval is only required for patients in Medicare Advantage plans, PET facilities, in the absence of clear, published Local Coverage Determination, will not know whether any Subsequent Treatment Strategy scan is covered, and thus to ensure payment will have to ask patients for Advance Beneficiary Notification. This is burden for PET facilities, but more important, many patients who need PET will decline, because they won’t or can’t bear the financial consequences of signing the Advance Beneficiary Notification .
3. Prostate cancer is a heterogenous disease as are all cancers. The value of FDG- PET has been demonstrated in small subsets of patients, particularly those with advanced castrate-resistant disease. Although we agree that, as CMS noted, there is now considerable interest in other tracers, such as C-11 choline, for imaging of prostate cancer, the vast majority of Medicare beneficiaries have no access to PET with these other tracers, which are not yet FDA approved or approved at only a single city in the United States. FDG-PET in prostate cancer should be covered along with the proposed coverage for all other cancers. It certainly should not be nationally non-covered. The decision to perform FDG-PET to address specific management questions in patients with prostate cancer should be left to treating physicians. Again, we recognize that the Medicare Administrative Contractors would retain the authority to define in their Local Coverage Policies those ICD-9 codes (or combinations thereof) that indicate medical necessity.
4. Finally, we wish to emphasize from our perspective 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. While we acknowledge that FDG-PET does not perform uniformly in every type of cancer, it no longer makes sense for CMS to micromanage physician use of this important cancer diagnostic tool.

Sincerely yours,

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I care for thousands of patients with head and neck cancer and sarcoma. It is critical to be able to access tumor response to therapy to provide optimal and excellent patient care outcomes. Based on my clinical and research experience at a large academic institution (Washington University and Barnes Jewish Hospital)and NCI Comprehensive Cancer Center (Siteman Cancer Center), the ability to perform multiple PET scans on a given patient during the initial therapy of their cancer is critical to being able to provide optimal and excellent outcomes to my patients.

The following proposed new rule will severely compromise optimal treatment decision-making for the majority of my patients with these two cancer types:

"CMS proposes that, subject to the exception in C below, one F18 fluorodeoxyglucose positron emission tomography (FDG PET) is covered under § 1862(a)(1)(A) when used to guide subsequent physician management of anti-tumor treatment strategy after completion of initial anticancer therapy. Coverage of any additional FDG PET scans used to guide subsequent physician management of anti-tumor treatment strategy after completion of initial anticancer therapy will be determined by local Medicare Administrative Contractors."

A single PET scan per cancer diagnosis provides only a single static "moment in time" data point and does not take into account the evolution of a patient's disease course (which includes staging, assessment of tumor response during initial chemotherapy to correctly route patient's to optimal next definitive surgical or radiation therapy, assessment of final tumor response after completion of initial therapy, assessment of probable or confirmed disease recurrence and monitering of tumor response to disease recurrence). In effect, a single PET scan over the continuim of care of a patient with cancer is like equating a still photo to a motion picture -obviously, there is logfold greater information available in several PET scans that is useful in making staging and treatment decisions about the care of a patient with cancer compared to a single PET scan.

The second sentence of the ruling above is also concerning. Everytime a physician feels that an additional PET scan will be needed to optimize care for a given patient will require an appeal to the local MAC. I would expect that approach will result in a flooding of such queries into the local MAC. My concerns are that this strategy may result in 1)unfortunate delayed responses from MAC that could adversely impact timely patient care and 2) inequitable decisions to approve or deny PET scans.

Please revise the ruling above to permit physicians to order more than one PET scan.

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