National Coverage Analysis (NCA) View Public Comments

Positron Emission Tomography (FDG) for Solid Tumors

Public Comments

Commenter Comment Information
Eakle, Janice Date: 04/13/2013
Comment:
I am a practicing oncologist in Florida and also a family member of a cancer patient currently undergoing chemotherapy. PET scans are an integral part of proper assessment and treatment decision making for many patients, especially during active therapy. I agree that these scans are not appropriate for surveillance. But they are invaluable when ordered appropriately. Please consider this necessity for the optimal care of cancer patients.
Goodhope, Karen Date: 04/13/2013
Comment:

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 subseque

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Randall, Stephen Date: 04/13/2013
Comment:

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

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Fair, Joanna Title: Assistant Professor of Radiology
Organization: University of New Mexico
Date: 04/13/2013
Comment:

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

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Grossman, Stanley Organization: Baylor University Medical Center
Date: 04/12/2013
Comment:

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

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Hong, Waun Ki Title: Division Head of Cancer Medicine
Organization: The University of Texas MD Anderson Cancer Center
Date: 04/12/2013
Comment:

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

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Bujor, Cayetana Date: 04/12/2013
Comment:
I am very concerned about this. [PHI Redacted] A CT Scan will often times NOT pick up activity that PET scan picks up. I[PHI Redacted] Medicare Needs to cover PET scans every 3 months for agressive/unpredictable cancers like Clear Cell Ovarian Cancer. Please - I beg you - Help Us!
Sheinkopf, David Date: 04/12/2013
Comment:
The introduction of FDG PET has changed the way cancer patients are managed. In many cases, cancer is now a chronic disease. This technology, along with other advances in cancer management, has helped oncologists design individualized cancer treatment strategies for their patients resulting in long term quality survival. The identification of those individuals likely to benefit from a more aggressive approach to management often depends on the results of physiologic imaging such as FDG

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Duncan, MD FACP, Lewis Title: Medical Oncologist
Organization: Texas Oncology
Date: 04/12/2013
Comment:
Sirs: Thank you for broadening the coverage of PET indications. As a practicing medical oncologist of 35 years, I can tell you that nothing has improved cancer care more that PET scans. In evaluating patients, it has saved many unnecessary surgeries and biopsies. It has helped patients also find relapses quicker and more accurately when they can be better treated. It is mainly used by me for staging accurately and evaluating for relapse
Chuy, Jennifer Organization: Montefiore-Einstein Center for Cancer Care
Date: 04/12/2013
Comment:

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

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Fowler, Nathan Title: Director, Clinic Research
Organization: Dept of Lymphoma/Myeloma, MD Anderson Cancer Center
Date: 04/12/2013
Comment:

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

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Bartlett, Nancy Title: Professor of Medicine
Organization: Washington University School of Medicine
Date: 04/12/2013
Comment:

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

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Lowe, Carol Date: 04/12/2013
Comment:
With cancer now being so rampant it's important to use all means available to try to treat at the earliest possible time. If we have the means to test and treat why wouldn't we do it. A life is a life and no one should lose it because we didn't think it was cost effective. Just about everyone we know has or is related to someone with cancer these days.
Durie, Brian Title: Chairman & Specialist of Myeloma/Related Diseases
Organization: International Myeloma Foundation (Chairman) & Cedars-Sinai
Date: 04/12/2013
Comment:

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

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Reddy, Suraj Title: Director of Body Imaging at BUMC
Organization: Baylor University Medical Center
Date: 04/12/2013
Comment:
Thanks for the chance to respond and comment on the CMS recent proposed decision for coverage of FDG PET imaging of solid tumors. I would like to strongly support the other comments made by the radiology, oncology and nuclear medicine societies regarding the restriction of patients to one PET in their lifetime. I have worked with several patients in which CT and MRI were indeterminate for recurrence and PET was the key to the decision of treatment plans. PET also often helps to find distant

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Diaz, Michael Title: Medical Oncologist
Organization: Florida Cancer Specialists
Date: 04/12/2013
Comment:

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

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Pajares, Judith Date: 04/12/2013
Comment:

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

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Thompson, MD, Mark Title: President, Board of Directors
Organization: Community Oncology Alliance
Date: 04/12/2013
Comment:

April 12, 2013

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

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

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Schneider, Marcia Date: 04/12/2013
Comment:

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

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Edwards, Risa Title: Senior Administrative Assistant
Organization: Texas Oncology
Date: 04/12/2013
Comment:
As a 20-year caregiver for multiple cancer victims within my family, I firmly believe the availability of PET, without limitation to the number, should be at physicians' discretion. True fraud focus would be more prudent than care rationing. Once again, CMS reveals its lack of concern for the patient.
Spies, William Title: Professor of Radiology
Organization: Northwestern University Feinberg School of Medicine
Date: 04/12/2013
Comment:

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

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Thevenot, Laura Title: Chief Executive Officer
Organization: American Society for Radiation Oncology (ASTRO)
Date: 04/12/2013
Comment:

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

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Presto, Steven Title: Supervising PET/CT technologist
Organization: US Oncology
Date: 04/12/2013
Comment:

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

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Seattle Cancer Care Alliance, . Title: Hubert Vesselle Ph.D., M.D., Radiation Oncology
Organization: Seattle Cancer Care Alliance
Date: 04/12/2013
Comment:

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

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Loo, Billy Organization: Stanford University
Date: 04/12/2013
Comment:

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

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Horn, Erica Title: Executive Director
Organization: HERO House
Date: 04/12/2013
Comment:

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

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Pham, Jimmy Tam Huy Title: OMS-II
Organization: Midwestern University
Date: 04/12/2013
Comment:
Jimmy Tam Huy Pham
Midwestern University
Arizona College of Osteopathic Medicine

I am writing in support of the further expansion of FDG-PET coverage as proposed by the National Oncologic PET Registry (NOPR) Working Group.

In my understanding, this would potentially benefit all oncology patients.

Zen, Qin Title: MD, PhD
Organization: New York Oncology Hematology
Date: 04/12/2013
Comment:

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

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Schlossberg, Howard Date: 04/12/2013
Comment:
PET/CT is a critical technology in diagnosing and monitoring treatment of cancer. Limiting scans to only two over a lifetime can make it difficult to manage patients. For example, a lymphoma patient may have a residual mass after treatment. A CT will only tell us the size of the lesion but the additional infomation a PET can provide in terms of activity could signal relapse before a CT would, potentially leading to a better outcome. There are many other scenarios where the functional/metabolic

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Wisniewski, Sandra Title: VP Marketing, Strategy & Business Development
Organization: Cardinal Health
Date: 04/12/2013
Comment:

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

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(ADCC), Alliance of Dedicated Cancer Centers Title: Executive Director
Organization: Alliance of Dedicated Cancer Centers
Date: 04/12/2013
Comment:
Download PDF of comment.
Belakhlef, Sam Date: 04/12/2013
Comment:

I have been working in the Positron Emission Tomography field for the last 20 years and have seen enough to convince me that 2 scans per cancer patient are not sufficient.

Cancer patients have their treatments switched more than once during their battles with cancers and therefore will be in need of more than 2 scans.

Bocchino, Carmella Title: Executive Vice Presidentq
Organization: America's Health Insurance Plans
Date: 04/12/2013
Comment:

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

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Butcher, Kent Title: CEO
Organization: Oklahoma Oncology
Date: 04/12/2013
Comment:

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

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de Leon, DO, Patricia Organization: Baylor University Medical Center at Dallas
Date: 04/12/2013
Comment:

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

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Flynn, MD, Thomas Title: Chairman
Organization: National Policy Board
Date: 04/12/2013
Comment:

April 12, 2012

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

By Online Submission

RE: Comments of The US Oncology Network on the Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Dear Dr. Jacques:

On behalf of the National Policy Board, physicians and

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Herman, M.D., M.Sc., Joseph M. Title: Associate Professor/Clinical Research Director
Organization: Johns Hopkins
Date: 04/12/2013
Comment:

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

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Kasper, M.D., Michael Date: 04/12/2013
Comment:

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

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Lyons, MD, FACP, Roger M. Title: Practice President
Organization: Cancer Care Centers of South Texas
Date: 04/12/2013
Comment:

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

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Rini, MD, Josephine Organization: North Shore-LIJ Center for Advanced Medicine, Mitchell A. Goldman, M.D. Diagnostic Imaging Center
Date: 04/12/2013
Comment:
I strongly support the NOPR’s response to CMS’s proposed coverage decision for FDG-PET/CT, as detailed in letter from Dr. Hillner, Dr. Siegel and Dr. Shields dated 4/11/2013 (http://www.cancerpetregistry.org/pdf/NOPRComment-CAG-00184R4-04-11-2013.pdf).
Tenenbaum, Esq., Cara Title: Vice President for Policy
Organization: Ovarian Cancer National Alliance
Date: 04/12/2013
Comment:

National Coverage Analysis (NCA) for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

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

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Vaitones, Virginia T. Title: MSW, OSW-C; President
Organization: Association of Community Cancer Centers (ACCC)
Date: 04/12/2013
Comment:

April 12, 2013

BY ELECTRONIC DELIVERY

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

Re: Proposed Decision Memo for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Dear Dr. Roche and Mr. Caplan:

The Association of

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Wilf MD, L. Habelson Title: Director of Oncologic Imaging
Date: 04/12/2013
Comment:

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

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Willen, MD, FACP, Michael Date: 04/12/2013
Comment:

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

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Zindel, Dr. Christoph Title: Chief Executive Officer
Organization: Siemens PETNET Solutions
Date: 04/12/2013
Comment:

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

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Latifi, Hamid Title: Director, Nuclear Radiology Fellowship Program
Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:

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

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Thurber, Betty Date: 04/11/2013
Comment:
[PHI Redacted] Pet scans are a tool for assessment or follow up for cancer patients, prescribed by our doctors. The doctor knows what is best for the patient, not the insurance company. Please do not take this tool away, cancer patients need to know they can live another day!
GUPTA, MANU Title: MD
Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:
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

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Zackon, Ira Title: MD
Organization: New York Oncology Hematology, P.C.
Date: 04/11/2013
Comment:

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

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Sankaran, Aarthi Title: MD
Organization: Baylor
Date: 04/11/2013
Comment:

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

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Dudek, Joseph Title: MD
Organization: New York Oncology/Hematology
Date: 04/11/2013
Comment:

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

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Lamey, Roy Title: Radiology Supervisor
Organization: Comprehensive Cancer Centers of Nevada
Date: 04/11/2013
Comment:

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

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Weisbruch, Gregory Title: Medical Imaging Fellowship Director
Organization: Baylor Hospital, Dallas TX
Date: 04/11/2013
Comment:

There is one section that must be corrected and that is the proposal that patients can only have ONE followup PET-CT scan in their lifetime. With cancer patients who have to change chemotherapy regimens or join a clinical trial there would be no cost-effective way to monitor therapeutic efficacy and therefore patients would suffer and the further advancement of knowledge in the field of oncology would be stifled. Such a blunder must be avoided.

Gregory J Weisbruch, MD

Shaw, Cathryn Title: Interventional Radiologist
Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:

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

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Philip, Joseph Title: Radiologist - Physician
Organization: American Radiology Associates
Date: 04/11/2013
Comment:

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

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Schuster, David Organization: Emory University
Date: 04/11/2013
Comment:

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

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Joyner, Kristin Title: Staff Radiologist
Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:

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

More

Wang, Jean Title: Staff Radiologist
Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:

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

More

Schucany, William Date: 04/11/2013
Comment:

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,

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Koya, Rama Date: 04/11/2013
Comment:
The usefulness of PET scan in my practice is that the PET scan helps in avoiding the use of chemotherapy if the PET scan is negative and sometimes avoiding the surgery. By limiting PET scans, there is a possibility of patients exposed to unnecessary treatments and related side effects
Gordon Don, Megan Title: Director, Government Affairs and Advocacy
Organization: Pancreatic Cancer Action Network
Date: 04/11/2013
Comment:

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,

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Bowman, Erin Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:

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

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Prepelica, Kristofer Organization: Memorial Sloan-Kettering Cancer Center
Date: 04/11/2013
Comment:

April 11, 2013

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

Re: Proposed Decision Memorandum for Positron Emission Tomography (CAG-00065R2)

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

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Takalkar, Amol Title: Medical Director
Organization: Biomedical Research Foundation of Northwest Louisiana
Date: 04/11/2013
Comment:

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

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Elledge, Nina Title: Oncology Nurse Navigator
Organization: University of Colorado Health System-North Campus
Date: 04/11/2013
Comment:
As a collective group of Oncology Nurse Navigators, we agree with CMS’s proposal to cover PET/CT scans for all solid tumors with the exception of prostate cancer. However, there is need to utilize more than one PET/CT scan in subsequent treatment strategy planning/restaging, and particularly for those patients undergoing active treatment in whom a change in treatment is being considered. For those patients who have completed therapy, and recurrence is suspected, the use of PET/CT is already

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Barker RT(T), Cas Title: Chief Raditation Therapist
Organization: Texas Oncology
Date: 04/11/2013
Comment:

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,

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Abraham, Brian Title: Sr. Policy Director
Organization: Medical Imaging & Technology Alliance (MITA)
Date: 04/11/2013
Comment:

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)

RE: Proposed Decision Memorandum for Positron Emission Tomography for Solid

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Perlman, Scott Title: Professor,Chief of NM,Director of UW PET Imag Ctr
Organization: University of Wisconsin School of Medicine and Public Health
Date: 04/11/2013
Comment:

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

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Encarnacion, Carlos Title: Clinical Research and Genetic Program Director
Organization: Texas Oncology Waco
Date: 04/11/2013
Comment:

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

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Nidhiry, Emmanuel Title: Oncologist.
Organization: Commonwealth Cancer Center.
Date: 04/11/2013
Comment:
I oppose the one-scan limit for FDG PET/CT imaging for cancer patients. PET/CT is a very important tool in helping to assess response to treatments in patients with metastatic disease and such a dramatic restriction will significantly affect my ability to take good care of the patients undergoing therapy. Why would you exclude THIS TEST and not the many other imaging and chemical marker tests?
Doner, Kevin Title: M.D.
Organization: Texas Oncology, PA
Date: 04/11/2013
Comment:
This policy will be a colossal mistake for cancer patients. For one, it is arbitrary and has no basis in science, it is clearly just based on cost control and rationing. Second, it will significantly compromise patient care. Cancer patients often require multiple imaging studies through the course of their care, for which judicious PET use is crucial. Allowing only 2 PETs will significantly impair our ability to monitor therapy and response, and obviously a high number of patients relapse and

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Swisher, Stephen Title: Head, Division of Surgery ad interim
Organization: The University of Texas M.D. Anderson Cancer Center
Date: 04/11/2013
Comment:
As Division Head of Surgery, I am writing to voice my support of the comment posted by the Section of PET/CT here at the University of Texas MD Anderson Cancer Center. My colleagues and I find FDG-PET/CT a valuable tool in the management of our patients, including those with lung cancer and esophageal cancer. The value of these scans extends beyond initial staging and immediate follow-up, helping us detect and manage disease when we have suspicion of recurrence. I request that CMS reconsider

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Willis, Elaina Title: Supervisor
Organization: Orlando Health - Orlando Regional Medicial Center
Date: 04/11/2013
Comment:

I am concern with the limitation on the number of subsequent treatment scan (especially on cancer that were already approved)

How will the Local Coverage Decision be coordinated; will there be education; so the process is clear

Gilbert, John Title: Radiologist
Organization: Rocky Mountain Radiologists, PC
Date: 04/11/2013
Comment:
I agree with CMS’s proposal to cover PET/CT scans for all solid tumors with the exception of prostate cancer. However, I absolutely emphasize the need to utilize more than one PET/CT scan in subsequent treatment strategy planning particularly for those patients undergoing active treatment in whom a change in treatment is being considered, and for those patients who have completed therapy, but recurrence is suspected. CMS should reconsider this proposed policy change.
smith, al Date: 04/11/2013
Comment:
Availability of PET at MD discretion enables quick response to reoccurances that might not be readily symptomatic.
Quick response might actually lower long term costs due to earlier intervention , shorter /less invasive treatment.
In reading blogs/website discussions, anecdotal info from countries where scans are not readily available, there seems to be more aggressive kthem less amenable to treatment.
MDs should be director of treatment for individual patients, not an

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Quinn, Michael Date: 04/11/2013
Comment:

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

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Love, Charito Title: Associate Attending Physician
Organization: Montefiore Medical Center-Albert Einstein College of Medicine
Date: 04/11/2013
Comment:

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

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Hillner, Bruce Title: Chair
Organization: National Oncologic PET Registry
Date: 04/11/2013
Comment:

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

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Ferguson, Judy Title: Lab Supervisor
Organization: Texas Oncology, P.A.
Date: 04/11/2013
Comment:

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

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Webb, M.D, Heather Organization: Baylor University Medical Center
Date: 04/11/2013
Comment:
I agree with the Joint-Society opinion. PET/CT is the most powerful tool available in documenting treatment response to therapy and tailoring further therapies. Restricting this exam to once in a lifetime would be devastating to the patients and physicians that are trying to battle these terrible diseases. I feel that this decision is not only wrong but unethical. I hope you reconsider this decision.
Szczesny, Cynthia Title: Lead PET Tecnologist, Adjunct Nuc Med Professor
Organization: Watson Clinic LLP, Hillsborough Community College
Date: 04/11/2013
Comment:
Limiting the number of PET scans for Cancer patients would not only be a great disservice to the patient, but also a great detriment to the already suffering health care system. In limiting or eliminating scans CMS will have to face further costs down the road for the advanced treatment of poorly monitored cancers. I urge all health care professionals and patients to voice their opinions against this proposed change.
Dockery, M.D., William Title: Chair, CV MRI and BHVH Radiology
Organization: Baylor Univ Medical Center, Baylor Heart and Vascular Hospital
Date: 04/11/2013
Comment:

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,

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Felter, Daniel Organization: Baylor University Medical Center - Dallas
Date: 04/11/2013
Comment:

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

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Tummala, Sudhakar Date: 04/11/2013
Comment:

I am practicing neurologist at MD Anderson Cancer Center. We encounter patients with tumor involvement of the central and peripheral nervous system.
I have found PET imaging useful for tumor infiltration of the nerves/plexus where other modalities could not adequately help.

PET was helpful for radiation necrosis.

PET is also useful for diagnosis of new tumor when we see patients with paraneoplastic syyndromes.

Smith, Jason Date: 04/11/2013
Comment:
This is not a one policy fits all issue. As we move towards personalized medicine in oncology, PET scans play an integral part. While the goal of treatment is an initial staging scan followed by therapy and a second scan documenting a complete response, we know that many patients will experience relapse. In that setting PET has an important role in documenting extent of disease to see if curative options remain (and to avoid unnecessary local interventions), determining a safe site to

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Tierney, Ryan Date: 04/11/2013
Comment:
This is a fundamentally bad policy idea that will worsen care for cancer patients. As patients with even advanced disease are living longer due to advances in radiation and chemotherapy, PET/CT is an invaluable tool to determine response to either treatment. While CT alone can give some information, PET/CT often can prevent the necessity for an invasive, expensive biopsy to determine response and thus guide the subsequent courses of care.
Sheinbein, Courtney Organization: Texas Oncology
Date: 04/11/2013
Comment:
This policy decision is not in patients' best interests. Our patients are frequently cured or placed into remission after an initial course of therapy. PET/CT scans are extremely important in detecting recurrence, response to therapy, and for modifying management and treatment decisions. Additionally, I have had many patients who have had additional disease found on PET, but not CT, that resulted in significant adjustment of the radiation treatment field, which significantly affected their

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Lockhart, Craig Organization: Washington University in St. Louis
Date: 04/11/2013
Comment:
Esophageal cancer is one of malignancies where FDG-PET is indicated for staging. We usually perform a pretreatment PET scan to rule out occult metastases before undertaking a potentially toxic neoadjuvant treatment approach with concurrent chemotherapy and radiation therapy. A PET scan is then repeated prior to surgery to assess the respone to therapy and to confirm that there has not been disease progression on treatment where surgery would no longer be indicated. On at least 2 occasions

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Young, Kari Title: Executive Administrator
Organization: Hematology-Oncology Associates, P.C.
Date: 04/11/2013
Comment:
We suggest clarification language in the final National Coverage Determination for use of PET for staging and restaging of oncologic disorders. We appreciate CMS’s recognition of the usefulness of baseline PET scans for initial treatment of most oncological cases including Myeloma, however there needs to be clarification of the following:
1. In Hodgkins Lymphoma and Diffuse Large Cell or other aggressive Lymphomas, guidelines such as NCCN version 1.2013 requires three PET scans; initial,

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mattern II, john Title: DO
Organization: Va Oncology Assoc
Date: 04/11/2013
Comment:
this would not follow standard of care for cancer pts. esp lymphoma pts
Sandbach, John Title: Regional Director Texas Oncology
Organization: Texas Oncology
Date: 04/11/2013
Comment:
A bad policy decision. The fundmental flaw is that it assumes cancer treatment is a one time event....the initial staging and a one time treatment episode. It does not recognize for instance the fact that a breast cancer patient frequently survives years and will have 6-8 treatment courses. PETs are now pivitol in decision making for oncology patients.
Grimes, Charles Organization: Center for Diagnostic Imaging
Date: 04/11/2013
Comment:
I am opposed to the stipulation limiting follow-up up imaging in patients who are being actively treated for cancer. 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.

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Tisone, Tom Title: Executive Director
Organization: Missouri Cancer Associates
Date: 04/11/2013
Comment:

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

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Bebee, Aneda Title: research/ LPN/CCRP
Organization: Virginia Oncology Associates
Date: 04/11/2013
Comment:
I work at an Oncology Treatment Center. WE have discovered quite some time ago that there are some patients with solid tumors that can not be detected by CT or MRI. We have some patients that have tumors that can only be detected with PET scans. We have come across this numerous times. If it had not been for the PET scan, some patients would have not been dx in a timely manner. Their follow-up treatment depends on them as well when we have to determine if there is disease progression.

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Lamont, Jeffrey Date: 04/10/2013
Comment:
PET is an essential preoperative tool for us. For example, we treat advanced solid tumors, such as metastatic colon cancer, more and more with surgery. Those patients require extensive screening and selection. CT scans can underrepresent the extent of disease in the abdomen that PET can pick up. It is quite cost effective to identify disease outside the limits of surgery with a scan before they get into the operating room. It is also quite a bit more tolerable emotionally for patients.

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Muscato, Joseph Title: Phyisican
Organization: Missouri Cancer Associates
Date: 04/10/2013
Comment:

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

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Dresser, Thomas Title: Chief, Nuclear Medicine Clinic
Organization: Harry S Truman Memorial Veterans Hospital
Date: 04/10/2013
Comment:
I oppose the one-scan limit for FDG PET/CT imaging for cancer patients. Many of our patients have benefitted from the detection of recurrent disease. It is common medical practice to moniter patients after therapy. Why would you exclude THIS TEST and not the many other imaging and chemical marker tests? Contact me and I can give you specific examples. T. Dresser PhD, MD
Laurie, Louba Date: 04/10/2013
Comment:
this is a major problem for cancer patients, who need to be monitored for treatment response. Often the only way to know if a lesion is active is by PET. This will leave many patients needing to pay out of pocket, or getting either inadequate or unnecessary therapy. It is a disaster in the making.
Kroeger, Michael Title: MIS, NMAA, PET, NCT
Date: 04/10/2013
Comment:

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

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Stone, Pamela Date: 04/10/2013
Comment:
The random choice of limiting a PET scan for 2 lifetime seems without any evidence to support his decision. I think a justification for obtaining a scan, and supporting this choice with evidence based medicine is the only prudent way to appropriately evaluate patients and control cost. Additionally, administrative decision such as these will have to be addressed with patients as opposed to penalties to physicians since the physician role ethically will otherwise be compromised
O'Shaughnessy, Joyce Date: 04/10/2013
Comment:
I am an academic breast cancer medical oncologist at Baykor Sammons Cancer Center in Dallas and Chair of US Oncology Breast Cancer Research Program. I have had a busy breast cancer practice for 18 years. Patients with locally advanced or metastatic breast cancer have along natural history, spanning from 2-3 years to more often 5-10 years, and even to 20+ years. PET CT scans are the ONLY way to be sure that all of the presenting nodal disease is known at diagnosis so that these nodal beds can

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kruger, scott Organization: USOncology,
Date: 04/10/2013
Comment:

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

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wender, donald Title: md phd
Organization: shoa
Date: 04/10/2013
Comment:
to limit to just two lifetime pets would clearly make oncology practice more difficult and may hinder us in detecting the amount of disease needed to treat especially in lung,breast, and colon cancers. in these cases these scan are immensly helpful not only for detection but quantifying the disease sites. in some case pets are superior than cat scans in detection and can o0ften replace whoole body cts and a bone scan. They are also quite helpful to determine respponse especially in lung

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Gillespie, Sarah Title: Clinical Educator
Organization: PET Imaging
Date: 04/10/2013
Comment:
We agree with CMS’s proposal to cover PET/CT scans for all solid tumors with the exception of prostate cancer. However, we absolutely emphasize the need to utilize more than one PET/CT scan in subsequent treatment strategy planning particularly for those patients undergoing active treatment in whom a change in treatment is being considered, and for those patients who have completed therapy, but recurrence is suspected.
Ernstoff, Marc Title: Professor of Medicine
Organization: Dartmouth Hitchcock Medical Center
Date: 04/10/2013
Comment:

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

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Castanon, Rosinda Title: Molecular Imaging Lead
Organization: VAMC GU Tumor Board
Date: 04/10/2013
Comment:
FDG PET/CT is useful for high risk prostate cancer patients and we have found that we were able to demonstrate dedifferentiated disease in a asmall cohort of patients. We conducted a pilot study combining FDG and Sodium Floride which found recurrent/metastatic disease in 12 out of 14 patients, none of which was seen on conventional imaging. Nine patients demonstrated disease on Prostascint Scans. Our findings were presented at the SNM annual meeting of 2012. Urologists at our center

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Briant MT(ASCP), Pauline Title: Lab Manager
Organization: Texas Oncology, PA - Presbyterian Hospital at Dallas
Date: 04/10/2013
Comment:

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

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Patton, Suzanne Title: Hematologist-Oncologist
Organization: Wellmont
Date: 04/10/2013
Comment:
While CT scans or CXRs may suffice for surveillance, PET is freq useful if an apparent solitary met is found that should be subject to local therapy, such as surgery, radiation, sterotactic radiosurgery with curative intent. This can happen sev times in the lifetime of a pt. I have one renal cell pt who recurs in a new place every couple years and has done this at least 4 times over the last 8 years. The surgeon or radiation doc is reluctant to deploy his local modality with the concern thast

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Courtright, Jay Date: 04/10/2013
Comment:
The consideration of limiting patients to only two PET scans during their lifetime regardless of medical need is short-sighted and ill-advised. PET imaging is necessary for staging and treatment planning as well as follow-up assessments and surveillance for many malignancies. PET scans are crucial for clinical-decision-making especially to avoid invasive procedures otherwise necessary to determine etiology of findings on other imaging modalities.
Andorsky, David Date: 04/10/2013
Comment:
This arbitrary lifetime limit of 2 PET scans for an oncology patient will greatly compromise my ability as a physician to provide optimal care for my Medicare patients. There are numerous scenarios where more scans over a patient's lifetime would be critical. For instance, a patient with a second lung cancer or a recurrent lung cancer, for repeat staging. Post-radiation scarring for lung cancer often appears like a tumor and PET is critical for distinguishing between a cancer recurrence and

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Ambrose, Heidi Title: PET/CT Team Coordinator
Organization: Sentara Healthcare
Date: 04/10/2013
Comment:
I have been working in the PET field for a little over 8 years now and am grateful for the increases in coverage for cancer indications that we have seen from the NOPR during this time. It has offered much needed PET scans to cancer patients to help with their care. While the need to end the NOPR is definitely a step in the right direction, the proposed decision to limit the number of PET scans a patient can have is a step in the wrong direction.
Most cancer patients will only have 1

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boren, patricia Title: patient benefit rep
Organization: compass oncology
Date: 04/10/2013
Comment:
Pet/Ct's are vital to treating cancer patients. Taking away necessary testing jeapordizes the health and welfare of these very sick patients. There are many other ways you can save on money, but not at the cost of someones health. These people have paid into this program all their lives and now you are planning to take this away. Please reconsider.
GORDAN, LUCIO Organization: FLORIDA CANCER SPECIALISTS
Date: 04/10/2013
Comment:

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

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Lanning, Bronwen Date: 04/10/2013
Comment:
I work in healthcare and understand the proposed limit on PET scans. [PHI Redacted] I know the impact that PET scans have had to identify cancer recurrences and give their physicians better tools to treat their cancers. CT and MRI do not provide the same data, according to our physicians. It's important to save lives. To reduce expenses, what about reducing mental health coverage or allergy testing? I know [PHI Redacted] (on medicare) have had those

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Fryefield, David Title: Radiation Oncologist
Organization: Willamette Valley Cancer Institute
Date: 04/10/2013
Comment:

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

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Medbery, Robbie Title: Medical Director
Organization: Radiation Oncology Services, Griffin
Date: 04/10/2013
Comment:
Comment: For the record, I am a radiation oncologist. I agree with the CMS decision to remove the NOPR requirements from the subsequent treatment imaging requirements for PET. I also agree that PET scans are of no utility in prostate cancers. However, the proposal to cover only one FDG PET scan for subsequent treatment strategy will strongly impact the care of my patients. For instance, patients may have a initial PET, chemotherapy, a second PET to determine if chemotherapy is effective,

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Lair, Bradley Date: 04/10/2013
Comment:
Limiting the number of follow up scans to one scan makes the PET scan a non functional test. If you cannot use the same test to track a patient's disease over time that test has no utility.
Powsner, Rachel Date: 04/10/2013
Comment:
Limiting PET-CT to 2 per lifetime for patients would be too restrictive at this time for our referring physicians who are currently using the test to gauge response to chemotherapy mid cycle in order to direct future care and then follow-up after completion of therapy or change in therapy to determine response. Also, in cases of recurrence by antatomical imgaging PET-CT is used to assess total extent of disease. Requiring local approval for more than 2 uses of PET-CT in a patient's lifetime

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Paulson, Roy Title: President
Organization: Texas Oncology
Date: 04/10/2013
Comment:
I am amazed at the proposed limitation of post treatment PET scans to "one" (with the caveat that any subsequent scans will be subject to local carrier blessing. One of the most effective tools oncologists have for follow-up and detection of recurrences in cancer patients is the PET scan. The limitations on this is certainly not based on any scientific data and again this is another challenge you have placed on the cancer patient in their already difficult battle.
Kemme, Douglas Date: 04/10/2013
Comment:
As a medical oncologist, I feel it is appropriate to repeat a PET scan to assess response to therapy. Please consider allowing a repeat PET scan to deliver optimal care to your patients.
Robinson, Cliff Title: Assistant Professor
Organization: Washington University in St. Louis
Date: 04/10/2013
Comment:

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

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Maker, Maureen Organization: none
Date: 04/09/2013
Comment:

[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

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Fleischauer, Scott Organization: Texas Oncology
Date: 04/09/2013
Comment:
I understand that PET is a relatively costly modality and I have no doubt some oncologists are overutilizing this test. I think some limitations on the use of it for routine screening for breast cancer and other solid tumors are certainly reasonable and warranted. However, I think the lifetime limitation is myopic and has potential to be problematic for patients . It will lead to unnecessary surgeries and biopsies. It is often used to evaluate residual or persistent mass present after

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Fan, Alice Organization: \
Date: 04/09/2013
Comment:
I am an oncologist. Limiting coverage to one initial and one post-treatment scan will not allow for adequate assesments of tumor response (such as an incomplete response at first post-treatment timepoint and subsequent treatment) nor adequate assessments for possible relapse following treatment.
Mankoff, David Organization: University of Pennsylvania/Abramsom Cancer Center
Date: 04/09/2013
Comment:

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

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

Dear Dr. Jacques,

As leaders in oncology and cancer imaging at the Perelman School of Medicine and the

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Quon, Andrew Date: 04/09/2013
Comment:

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

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Oza, Umesh Title: MD
Organization: Baylor University Medical Center Dallas
Date: 04/09/2013
Comment:

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

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Haithcock, Jeffrey Title: Physician
Organization: American Radiology Associates, P.A.
Date: 04/09/2013
Comment:

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

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Balasky, Glenn Organization: The Zangmeister Cancer Center
Date: 04/09/2013
Comment:

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

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Gomez, Conan Date: 04/09/2013
Comment:
I am writing to express my support for the joint society letter from the ACR, ACNM, ASNR, SNMMI, and WMIS. The proposed limit of a single post-treatment PET scan for tumors would be an utter disservice to cancer patients and would make diagnosing and treating these complex patients even more difficult. As a neuroradiologist, I work in a busy practice diagnosing and monitoring cancer patients, helping steer my oncology colleagues in the proper direction for therapy. Simply and logically put,

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Ward, Kim Title: Pt serv spec
Organization: Fla Cancer Spec
Date: 04/09/2013
Comment:
You MUST continue to cover Pet/CT scans for these cancer pts. It does save lives!
Israel, Mark Title: Director
Organization: Norris Cotton Cancer Center
Date: 04/09/2013
Comment:

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

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Ford III, MD, Ken Title: President Elect
Organization: American Radiology Associates, PA
Date: 04/09/2013
Comment:

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

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gwozdz, john Title: md
Organization: texas oncology
Date: 04/09/2013
Comment:
I am requesting reevaluation of proposed and already existing payment cuts for radiation oncology and pet scans for cancer patients. The radiation oncology field has become dramatically more complex and thus time and labor intensive to deliver precisely accurate radiation to cure cancer. The cuts in radiation oncology and pet scans used to target the cancer accurately are placing patients at risk for treatment that may inaccurately treat a normal tissue and injure it or miss the cancer

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Kramer, Lindsay Title: Clinical Educator
Organization: PET Imaging of Northern Colorado
Date: 04/09/2013
Comment:
We agree with CMS’s proposal to cover PET/CT scans for all solid tumors with the exception of prostate cancer. However, we absolutely emphasize the need to utilize more than one PET/CT scan in subsequent treatment strategy planning particularly for those patients undergoing active treatment in whom a change in treatment is being considered, and for those patients who have completed therapy but recurrence is suspected.
Wright, Gail Title: Physician-Partner
Organization: Florida Cancer Specialists
Date: 04/09/2013
Comment:
Regarding a recently proposed decision memorandum from the Centers for Medicare and Medicaid Services (CMS) to limit positron emission tomography (PET) imaging to 2 per lifetime for oncology patients, I believe this would be imposing a severe limitation in management of these patients. PET scans are a very sensitive indicator of the extent and activity of malignancies in our oncology patients. PET scans will often demonstrate earlier evidence of response and/or progression of malignancies

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Bhujwalla, Zaver Title: President
Organization: World Molecular Imaging Society
Date: 04/09/2013
Comment:

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

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Moore, James Date: 04/09/2013
Comment:
As a medical oncologist, a lot of our treatment planning and management is based on PET/CT scans. Your current proposal grossly undercuts our ability to provide good and accurate care.
Mason, David Date: 04/09/2013
Comment:
I believe this policy is too restrictive and will greatly compromise patient care. If there are clinical or radiologic concerns for recurrence documented by a clinician or CT scan, a PET scan should be available to help manage the patients care.
Pearl, Cathleen Date: 04/09/2013
Comment:

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

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Raymond, Daniel Title: Staff thoracic surgeon; Quality Director
Organization: Cleveland Clinic Foundation
Date: 04/09/2013
Comment:
I have concerns regarding the limitation of PET scanning to one post-treatment scan as this may significantly impair our ability to appropriately assess sites of recurrent disease. Clearly, surveillance PET scanning needs to be curtailed, however, the strict limitation to a single scan is too dogmatic and restrictive for even the most conservative physician. My fear is that it will result in an increase in the number of CT scans and could result in an increase in invasive procedures with a

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Way, William Organization: Wake Radiology Consultants
Date: 04/09/2013
Comment:
I agree completely with the proposal to end NOPR data collection for FDG PET as it is written.
Birkemeier, Amy Title: Radiology Compliance Manager
Date: 04/09/2013
Comment:
I agree with the elimination of data collection for CED as PET Scans have proven to be beneficial for non-invasive diagnosing and staging of cancer. I however do disagree with only covering 1 subsequent scan as this will deter patients from getting subsequent PET scans when they are in the middle of chemo/radiation treatment to monitor their progress. Not being able to monitor these patients throughout their entire treatment could raise the overall cost in the long run. Thank you for

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Carson, Kenneth Title: Assistant Professor of Medicine
Organization: Washington University in St.Louis, SCHOOL OF MEDICINE
Date: 04/09/2013
Comment:

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

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Gould-Simon, Aron Organization: UT Southwestern Medical Center
Date: 04/08/2013
Comment:

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

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Soni, Neeta Date: 04/08/2013
Comment:

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

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Porter, Lester Title: Physician
Organization: Tennessee Oncology Group
Date: 04/08/2013
Comment:
PET testing in patients with reising colon cancer tumor markers has allowew a great number of patients to be cured by discovering the location of the cancer before CT scan can detect it. It would greatly reduce our chance to make potentially curable medical/ and surgical therapies if PET scans were limited by coverage as proposed by CMS.
McAneny MD, Barbara Title: MD, CEO
Organization: New Mexico Cancer Center
Date: 04/08/2013
Comment:

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

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Olszanski, Anthony Title: Director, Melanoma program
Organization: Fox Chase Cancer Center
Date: 04/08/2013
Comment:
It is imperative that PET continue to be covered for the surveillance of specific diseases. It is instrumental in colorectal cancer, for example, in a pt with a rising CEA but a negative CT scan. In fact, the use of a restaging CT scan is often not helpful at all. Likewise, the surveillance of patients with upper GI cancers or melanoma is inadequate with imaging modalities other than PET. I remain hopeful that CMS will recognize this as not only imperative for patient care, but also for

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veloski, colleen Title: Associate Professor of Medicine
Organization: Fox Chase Cancer Center
Date: 04/08/2013
Comment:
I support the proposal to end the CED for PET, but oppose just one PET scan for subsequent treatment strategy without approval from local MACs. PET-CT is a very valuable tool for us to assess response to therapy. There are now many different possible therapies for the same kind of cancer. If one therapy fails, we can quickly assess and change therapies. We must be able to perform the PET-CT at specific times during therapy without undue delay or administrative red tape/paperwork/costs.
Kohrs, Dana Title: secretary
Organization: Arkansas Oncology Associates
Date: 04/08/2013
Comment:
I work for cancer doctors. This is a bad idea limiting pet ct scans to two per lifetime. This is an invaluable tool that the doctors use to guide them in treating cancer patients. It also catches cancers that may be too small to catch on a CT scan but prior to patient having symptoms. If you want to limit pet scans, how about limiting it after they complete treatment and are in remission for a couple of years. Maybe limit it to 5 lifetime Pets? If CMS really wants to save money, make

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Czernin, M.D., Johannes Organization: David Geffen School of Medicine at UCLA
Date: 04/08/2013
Comment:

Comment to CMS related to FDG-PET coverage policy

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

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Robb, Bruce Date: 04/07/2013
Comment:
I am a colorectal surgeon whose managment decisions are influenced by PET/CT scans on a daily basis. I strongly oppose the proposed decision to limit the coverage of FDG-PET to one subsequent treatment strategy study per patient. This limitation would severely limit my ability to provide my patients quality care and would result in both over- and under-treatment of my patients, ultimately significantly driving up the costs of medical care.
Pracht, Laurel J. Title: Patient Advocate
Organization: SNMMI, OCNA, GOG
Date: 04/07/2013
Comment:
Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services

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

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Rohren MD PhD et al, . Title: Sec Chief, Admin Dir, & Chair of Nuclear Medicine
Organization: The University of Texas MD Anderson Cancer Center
Date: 04/05/2013
Comment:

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

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Aaron, Vasantha Organization: Indiana University School of Medicine
Date: 04/05/2013
Comment:
I am a radiologist 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 and the second leading cause of death in the United States, exceeded only by heart disease. All of us have family and friends with cancer and it affects every American. Cancer is not a one-time event. Cancer can come back a second and third time and

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McCulloch, MD, Tim Title: Professor and Chairman
Organization: Otolaryngology Head & Neck Surgery, University of Wisconsin
Date: 04/05/2013
Comment:

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.

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Abid,MD,FACP, Dr. Syed Title: Dr.
Organization: Oncology & Hematology
Date: 04/04/2013
Comment:

This decision to limit Pet scan use will affect the staging of cancer patients as well as outcome based on sometimes inaccurate staging.
smaller community oncology practices will be the one suffering most quality wise.

The problem with cost and Pet scan over use and abuse is a concern and associated with larger practices who owns a pet scanner.

It would be better to not allow pratices to owm pet scanners rather than severly limiting its use for every physician.

Peyton, James Title: M. D.
Organization: Tennessee Oncology
Date: 04/04/2013
Comment:

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

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Humphrey, Bradley Title: Supervisor Nuclear Medicine
Organization: University of Minnesota Medical Ctr, Fairview
Date: 04/04/2013
Comment:
I have been directly involved with pet scanning and managing NOPR cases for 5 hospitals since CED inception. I can attest that clinicians are doing on average, more than 4 pet scans on their patients, and clearly noted under NOPR post pet forms, that the clinical data is beneficial, providing both accurate and quick feedback on tumor response to a variety of therapeutic regimes. Restrictions based on economic reasons are ill-founded, clinicians will simply employ alternative testing, yielding

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Powell, Matthew Title: Associate Professor
Organization: Washington University.
Date: 04/04/2013
Comment:
The the proposed one-scan limitation for subsequent patient management is not medically appropriate. For patients with locally advanced cervical cancer that have undergone chemoradiation the 3 month post treatment PET is the best predictor of outcome. We often need to intervene with additional therapies based on this scan. Often the scan can be indeterminate and additional scans are needed to clarify if surgery is indicated.
skinner, cheryl Title: PHYSICIAN
Organization: LEBANON HEME ONC
Date: 04/04/2013
Comment:
I wholeheartedly disagree with the new limitation proposal concerning PET/CT scans for patients. I provide cancer care to patients and the PET/CT scan has clearly helped us follow patients for recurrent cancers and second malignancies. To limit coverage over a lifetime is basically saying toa patient we do not care about you and will allow you to die. This is wrong.
Armstrong, R.Ph., Stacy Title: Director of Pharmacy Services
Organization: Texas Oncology-Paris, TX
Date: 04/04/2013
Comment:

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

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Ioffe, Vladimir Title: Radiation Oncologist
Organization: 21st Century Oncology
Date: 04/04/2013
Comment:
I am a radiation oncologist. In our specialty, we are increasingly using PET/CT for radiation targeting in the actual treatment planning process. CT imaging alone is inadequate to delineate many tumors. For example, in lung cancer, tumor frequently cause airway obstruction with post obstruction lung collapse. Based on CT imaging alone, I can not determine what part represents tumor vs. collapsed normal lung, this can only be seen by the PET/CT. Also after radiation treatment, frequently

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Eicher, Heather Title: Business Office Manager
Organization: Mahoning Valley Hematology Onc Assoc Inc
Date: 04/04/2013
Comment:
community based oncologists who have utilized PET scans for assessing efficacy of therapy, deciding when a new therapy should be instituted, assessing new or persistent abnormalities seen on CT or MRI, assessing the significance of rising tumor markers, or delineating suspected recurrences earlier than is possible with other imaging modalities, this will create a major void in our ability to manage patients.
Fintel, William Title: President
Organization: Blue Ridge Cancer Care
Date: 04/04/2013
Comment:

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

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Andrews RN, Lori Date: 04/04/2013
Comment:
This is truly a misguided effort to cut costs. It is vital that patients with certain types of cancer be allowed as many PET CTs as the treating MD determines is necessary to steer treatment. 2 scans per lifetime is not standard of care in any line of cancer treatment. These scans are crucial to determine the effectiveness of treatments and when to switch treatments. How many a year are a congressman/woman or senator entitled to under their healthcare coverage?
Carol, Rhoades Title: RN BSN OCN
Organization: U. S. Oncology
Date: 04/04/2013
Comment:
As an oncology nurse, I foresee that accurately diagnosing and planning treatment for our patients will be severely and negatively impacted by the ruling to allow only two PET scans per lifetime. Treatment planning will become a "stab in the dark" for our patients, and will most certainly decrease survival rates. Please reeducate yourselves and reconsider this ruling.
DeMarco, Sue Title: Practice Administrator
Organization: US Oncology
Date: 04/04/2013
Comment:
I not only work with cancer patients but [PHI Redacted]. I can not understand why we want to limit the care and follow up treatment of patients that are fighting cancer. We seem to care more about sending out money to other countries than we do about taking care of our people.
Fletcher, MD, FACR, James W. Title: Professor of Radiology and Imaging Sciences
Organization: IU School of Medicine,Department of Radiology & Imaging Sciences
Date: 04/04/2013
Comment:

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

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Brassell, Jr., Robert Title: SOLE, PRO BONO Estate Administrator, INCLUSIVE
Organization: Delois Albert Brassell Estate (CAGE Code 5PAZ8) et al., ALL INCL
Date: 04/03/2013
Comment:
Speaking and acting within ALL, ALL INCLUSIVE, my capacities, ALL INCLUSIVE, INCLUDING AND ESPECIALLY as the respective SOLE, PRO BONO Administrator of the Delois Albert Brassell Estate (D-U-N-S Number 831823948, active CAGE Code 5PAZ8), Robert James Brassell Estate (D-U-N-S Number 962019514, active CAGE Code 64WJ9), Annie Bell/Belle Albert Estate (United States EIN 27-6382218), Trudie Brassell Estate (United States EIN 90-6214502), Len Albert Estate (United States EIN 35-6822992), Charles

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Cordes, Susan Title: Associate Professor
Date: 04/03/2013
Comment:
I am a surgeon whose managment decisions are influenced by PET/CT scans on a daily basis. I strongly oppose the proposed decision to limit the coverage of FDG-PET to one subsequent treatment strategy study per patient. This limitation would severely limit my ability to provide my patients quality care and would result in both over- and under-treatment of my patients, ultimately significantly driving up the costs of medical care.
Rigas, M.D., James R. Title: Professor of Medicine
Organization: Dartmouth Hitchcock Medical Center
Date: 04/03/2013
Comment:

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

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Waxman, Alan Title: Director of Nuclear Medicine
Organization: Cedars Sinai Medical
Date: 04/02/2013
Comment:
The elimination of additional FDG PET for at least one year would adversely impact the oncologist to effectively monitor the patients response to treatment. This may result in a failure to detect an inappropriate therapeutic regiment and in the long run be dangerous to the patient and be more costly to the health system. Punting to the local reimbursement authorities will result in uneven care and decisions will be inconsisent and discouriging to tghe refering physician.
Delbeke, Dominique Title: Professor and Director of Nuclear Medicine/PET
Organization: Vanderbilt University Medical Center
Date: 04/02/2013
Comment:

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

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Lampke, Alison Date: 04/02/2013
Comment:
I believe The proposal will benefit patients with solid tumors (and their treating physicians) by providing the demonstrated advantages of FDG PET for subsequent patient management without the data collection burden currently required under the NOPR.
I suggest and Request Removal of One-Scan Limit.
I Suggest that the proposed one-scan limitation for subsequent patient management is not medically appropriate. For instance, the prevailing standard of care for some indications

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Northcutt, David Title: Businss Development Manager
Organization: DMS Health Technologies
Date: 04/02/2013
Comment:

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

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Taketa MD, Richard Title: Director of Imaging
Organization: Cancer Center of Irvine
Date: 04/01/2013
Comment:
I agree with the NOPR FDG PET conclusions regarding solid tumors, including the exclusion of prostate cancer. I would recommend the continuing NOPR study of F18 NaF PET Bone Scans since this examination appears to be superior to routine Tc Bone Scans when evaluating prostate cancer.
Borinstein, Scott Title: Assisatant Professor, Pediatric Oncology
Organization: Vanderbilt University
Date: 04/01/2013
Comment:

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

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Yu, Jian Title: Chief, Nuclear Medicine and PET Service
Organization: Fox Chase Cancer Center
Date: 03/29/2013
Comment:

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

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Van den Abbeele, Annick Date: 03/28/2013
Comment:

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.

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Soeten, Laura Date: 03/27/2013
Comment:
You have to be kidding! limiting PET scans to 2 per person per life? Ok so you are only allowed to get and recover from cancer once cause it never recurs. Get real!
Shelton, Justine Title: Yoga Therapist
Organization: Yoga Vista Academy, Inc. and Yoga with Justine, Inc.
Date: 03/27/2013
Comment:
It has come to my attention that Medicare is considering limiting PET scans to 2 per patient for life. As a CAM provider for cancer patients the last 6 years I find this outrageous. PET scans inform doctors of progression and how to move forward with treatment. Limiting them to such a ridiculously low number, when the technology is readily available, I find to be barbaric and an embarrassment to the US medical system. Please keep this necessary treatment vehicle available to all doctors and

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hofer, marie Date: 03/27/2013
Comment:

[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

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malik, john Date: 03/26/2013
Comment:
This is to amend the previous comment re restrictions of pet procedures to be limited to twice per lifetime.
I object to this severe restriction to a vital tool which greatly benefits sufferers of lymphoma and should not be so severely limited in its application.I strongly urge that no such limitations be further considered.
Martin, William Title: Professor
Organization: Vanderbilt University
Date: 03/26/2013
Comment:

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,

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malik, john Title: private citizen with family member with lymphoma
Date: 03/26/2013
Comment:
I protest the propsed restrictions re two pet scans per year.This is a vital tool which can ascertain what treatments are likely to afford adequate case management.
Jadvar, Hossein Title: Associate Professor of Radiology
Organization: University of Southern California
Date: 03/26/2013
Comment:

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

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Powers, Ann Date: 03/25/2013
Comment:
It has been my experience that the oncologist request and recommendation for PET scans has been very beneficial for initial diagnosis and also for restaging purposes. It is my understanding that this tool is the best way to follow the effectiveness of treatment. The PET scan can allow the physician to see the internal effectiveness before it becomes external. In my option the oncologist request should always be the determining factor. I am against the 2 PET scan limitation.
Walker, Ronald Title: Member/Investigator Vanderbilt-Ingram Cancer Cente
Organization: Vanderbilt University Medical Center
Date: 03/25/2013
Comment:

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

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Adkins, M.D., Douglas Date: 03/21/2013
Comment:

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

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vij, ravi Date: 03/20/2013
Comment:
I would strongly suggest reconsidering of proposed policy change for PET scans. I am an academic specializing in the treatment of patients with multiple myeloma.In patients with multiple myeloma this is a very useful modality to follow patients with non/secretory oligosectretory disease. The number of such patients is growing as patients are living longer with advances in therapy and later in the disease course the number of oligosecretory patients is increasing
Juneau, Jeremiah Title: CNMT, PET, RT(R)(N)
Date: 03/19/2013
Comment:
The proposal of only ONE FDG-PET scan for subsequent treatment strategy indications for all cancers is absurd. Not only will this lead to the presence of unknown recurrences of malignancies (causing patients to miss their early target time for additional treatments), but this will lead to huge sums of medical costs for the CMS & patients due to uneeded CTs, XRays, MRIs, Biopsies, etc. PET/CT is proven to cut down on all of these additional medical procedures when patients with a history of

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Messer, Guy Title: Owner
Organization: Trident Medical Imaging
Date: 03/19/2013
Comment:
I applaud CMS' decision to remove the NOPR requirements from the subsequent treatment imaging requirements for PET. I have great reservations, however, over the decision to limit Medicare recipients to one sebsequent treatment PET scan. As an owner and operator of PET centers for 10 years I see the frequent need on the part of referring physicians to follow their patients with PET as they treat their patients' cancers. Limiting their PET tool to only one scan post treatment would be

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Malik, Eileen Date: 03/19/2013
Comment:
Defunding PET scans at any phase of cancer treatment is akin to a death panel. These scans are an invaluable tool for Oncology Doctors and Patients [PHI Redacted] who have been in and out of treatment for years.
The President said, my insurance wouldn't change, that it wouldn't cost more, that death panels were not in our future, and so far he has lied on all counts [PHI Redacted]. Shame on all of you.
Odom, William Date: 03/19/2013
Comment:

Allowing only one PET scan for subsequent treatment is not acceptable. Many times several scans are performed to determine the apprpriate therapy. Please reconsider.

William Odom
V.P. Louisiana PET/CT Imaging
Texarkana PET/CT Imaging
Open Air Imaging

roberson, kim Date: 03/16/2013
Comment:
I have worked with cancer pts since 1997. I remember the impact of not being able to get a pet scan for pt's because it's not covered by mcr. People's lives are dependent upon the results of these scans. This proposed end to the pet registry is horrid. The pet registry has been able to help so many cancer pt's and now they won't have that option and Dr's won't have this as a treatment determination. This is a sad state of patient care (of lack of if I were to be more precise).
Farukhi, Irfan Date: 03/15/2013
Comment:
The current exclusion of Prostate Cancer could negatively impact some patients. Suggest CMS cover initial F18-FDG PET for all cancer diagnoses and subsequent F18-FDG PET imaging based upon the tracer avidity documented at baseline.
White, Courtney Date: 03/14/2013
Comment:
I just have a pretty simple question. There are many rare cancers that are not officially listed in the CMS guidelines. Would they be considered other? And if so that means they are covered. Even basal cell skin cancers and things of that nature. So all a medicare patient has to do is have been diagnosed with any cancer besides prostate and their test will be covered?
Severson, Dona Date: 03/14/2013
Comment:
Limiting PET scans for subsequent treatment strategy to a maximum of one scan will greatly impact patient treatment and outcome. I urge CMS to NOT limit followup PET scans to one per patient. If necessary, continue with the NOPR so patients may receive the care they need.
Duvall, Jenny Title: PET-CT Technologist
Organization: MRHC
Date: 03/14/2013
Comment:

If the NOPR goes away, will Medicare fully cover NaF PET Bone Scans? Prostate cancer is a good indication for performing a bone scan.

Also, will there be a system put into place (i.e. pre-auth guidelines) that outlines how subsequent scans will be determined necessary or not?