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Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer

Public Comments

Commenter Comment Information
Capristo, Marco Title: Director of PET/CT Imaging
Organization: Ascent Diagnostic Imaging of Tamarac
Date: 12/30/2009
Comment:

NaF-18 PET for the detection of Bone metastasis should be covered. Sodium fluoride bone scans are highly sensitive for bone metastatic disease of both osteoblastic and osteolytic cancers. There is essentially no comparison with traditional Tc99m bone agents (MDP, HDP) versus NaF. Sodium Fluoride bone scans provide higher accuracy in differentiating benign from malignant lesions and provide a much more superior image quality. Also, with the "coctail" of FDG and NaF in one scan, patient care

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Djang, David Date: 12/30/2009
Comment:

1. CMS should approve broad coverage of NaF bone imaging because:
- it is a bone scan and should be covered
- the literature supports NaF PET bone scanning and in fact, shows that it is more accurate than traditional bone scans
- patients need access to an alternative to Tc-99m based bone scans because the supply of molybdenum has been problematic for the last two years and this could continue through 2010

2. If NaF is not broadly covered, then we recommend

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Treves, Ted Title: Chief, Division of Nuclear Medicine and Professor
Organization: Children''s Hospital and Harvard Medical School
Date: 12/30/2009
Comment:

I would like to propose that the indications for NaF-18 PET studies is not limited to the investigation of bone metastasis. Why limit its use? This imaging procedure is also very effective for the assessment of non-oncologic disorders of bone. Since 2004 at Children''s Hospital Boston, we have performed in excess of 500 NaF-18 PET studies in children ranging from neonates to young adults. The vast majority of the indications have been for non-oncologic disorders (sports injuries, child

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McCarthy, Timothy Title: President
Organization: Academy of Molecular Imaging
Date: 12/30/2009
Comment:

We are writing in response to the Centers for Medicare & Medicaid Services’ (CMS) request for comments on the proposed decision memorandum for the use of Positron Emission Tomography (PET) (18F-NaF) to identify bone metastasis of cancer. For the reasons stated in our earlier comment and reviewed below, we believe that the available evidence is sufficient to support Medicare coverage for 18F-NaF PET and PET/CT (referred to herein collectively as

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Podoloff, Donald Title: Professor and Levit Family Distinguished Chair
Organization: U.T. MD Anderosn Cancer Center
Date: 12/30/2009
Comment:

Houston, December 29, 2009

Centers for Medicare & Medicaid Services Technology Assessment Committee

Dear Members,

This letter is to strongly support CMS to provide coverage for F-18 fluoride PET (and PET/CT) scanning for staging and monitoring of bone metastases in patients with breast cancer. Bone metastases are the commonest type of metastases from breast cancer, which is, in turn, the commonest form of malignancy in adult women in the US. Bone metastases cause significant

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Bocchino, Carmella Title: EVP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans (AHIP)
Date: 12/29/2009
Comment:

December 30, 2009

Jeffrey Roche, MD, MPH
Medical Officer, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Roche:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage decision (NCD) for Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of

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Korn, Ronald Title: Director of PET/CT and Nuclear Medicine
Organization: Scottsdale Medical Imaging Ltd
Date: 12/29/2009
Comment:

Thank you for the opportunity to comment upon the use of 18F Sodium Fluoride (NaF) bone scans for the detection of bone disease (CAG 00065R1). I am the director of PET/CT and Nuclear Medicine at Scottsdale Medical Imaging Ltd (SMIL), a community based private practice radiology practice in Scottsdale, Arizona. I have been performing and interpreting gamma camera based 99m Tc MDP-bone scans for the last 15 years. Over the last two years, our practice has begun utilized 18F-NaF bone scans

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Krynyckyi, Borys Title: CEO
Organization: PCMI
Date: 12/29/2009
Comment:

Personal Care Molecular Imaging

We have performed over 15 F-18 sodium fluoride PET bone scans on the clinical level.

Quite simply, they are vastly superior to conventional planar bone scan imaging, and also vastly superior to SPECT imaging. Why?, because the PET bone scan requires a low dose CT for attenuation correction of the data, and this low dose CT data is available from the vertex to the toes. The combination of metabolic information extracted from the PET portion as well as the

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Hillner, Bruce Title: Chair
Organization: National Oncologic PET Registry Working Group
Date: 12/29/2009
Comment:

As the Chair and Co-chairs of the National Oncologic PET Registry (NOPR) Working Group, we are writing in response to the Centers for Medicare & Medicaid Services’ (CMS) request for public comment on the proposed decision memorandum for the use of Positron Emission Tomography (PET and PET/CT) with the radiopharmaceutical fluorine-18 sodium fluoride (18F-NaF) to identify bone metastasis of cancer, and the proposal to provide coverage for 18F-NaF PET through the use of

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Lamkin, RN, MPH, Luana R. Title: President
Organization: Association of Community Cancer Centers (ACCC)
Date: 12/28/2009
Comment:

December 29, 2009

BY ELECTRONIC DELIVERY

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, Maryland 21244

Re: Proposed Coverage Decision Memorandum for Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer (CAG-00065R and CAG-00065R1)

Dear Dr. Jacques:

The Association of

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PFISTERER, WILLIAM Title: president
Organization: california diagnostic imaging
Date: 12/28/2009
Comment:

Having utilized f18-pet bone scan imaging for the past year it can be stated without reservation that it is dramatically more accurate in identifying whether certain areas of uptake are related to malignancy or benign processes. This is because the addition of CT makes such an accurate localization of the uptake. Also, the dramatic sharpness of the images certifies the region of interest is real rather than vague. A real patient protector.If approval is not forthcoming a NOPR like trial

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Ager, Jeffrey Title: Physician radiologist
Organization: Rockwood Clinic, PS
Date: 12/28/2009
Comment:

PET NaF-18 bone imaging is a more accurate modality than simple bone scanning for detection and characterization of bone lesions, especially metatases. It has and will provide more accurate staging for most cancers, and will be more likely to upstage cancers and save money in the long run. It provides an alternative for staging patients when technetium is unavailable (as has commonly occurred recently). It has been used extensively in my state (Washington) and I would like to provide that

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Vesselle, PhD, MD, Hubert Title: Director, Division of Nuclear Medicine
Organization: University of Washington
Date: 12/27/2009
Comment:

NaF PET bone imaging is to be used in place of and is superior to routine bone scintigraphy and SPECT bone imaging, as demonstrated in the published literature referenced by CMS.

PET bone imaging with NaF-18 provides multiple benefits over routine scintigraphy with Tc-99 MDP:

1) Imaging with NaF can start 90 minutes after injection in contrast to Tc-99 MDP bone scintigraphy that requires a 3-hour delay. This results in faster turn around time for patients who are often in pain and

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khandani, Amir H. Title: Associate Professor, Director, PET Services
Date: 12/27/2009
Comment:

There is a significant body of literature (most of the published by groups around Einat Even-Sapir, Israel and Holger Schirrmeister, Germany) indicating the higher sensitivity and specificity of NaF bone scan compared to conventional bisphosphonate bone scan. It should be noted, however, that NaF bone scan is more expensive to acquire (higher cost of a PET scanner compared to a SPECT camera) and more time consuming to read than bisphosphonate bone scan. Therefore, the indications for NaF

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Herman, Edward Title: radiologist
Organization: northern arizona radiology
Date: 12/25/2009
Comment:

NaF-18 PET bone imaging is far more sensitive than standard tech 99 MDP bone imaging and localizes lesions more accurately, it also readily available with no shortage of the imaging agent and gives patients an alternative method for skeletal imaging. It seems unfair that this imaging method would not be reimbursed.

Jacobson, Marc Date: 12/23/2009
Comment:

I am an oncologic imaging subspecialist with broad expertise in PET-CT imaging. I was trained in PET-CT at MD Anderson Cancer Center where I spent 12 years on faculty, and subsequently moved to Seattle, WA to join a radiology practice that was opening a PET-CT service. I have used F-18 NaF PET-CT, and have ready access to the radiopharmaceutical though out supplier, PETNet.

In my opinion, CMS should approve broad coverage of NaF bone imaging because it is a bone scan, and is different

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Rogers, MD, James Title: Medical Director, PETCT
Organization: Swedish Cancer Institute
Date: 12/23/2009
Comment:

December 23, 2009

Re: Proposed Decision Memorandum for Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer (CAG 00065R1) (CAG-00065R)

From: Clinicians, Radiologists, Nuclear Medicine Physicians at Swedish Cancer Institute, Seattle, WA.

F18-NaF Bone PET imaging is available from our PET provider and is used daily. The availabilty of F18-NaF at our institution has improved the diagnostic accuracy of bone scintigraphy over the past 7 years.

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Lamoreaux, Wayne Title: Radiation Oncologist
Organization: Cancer Care Northwest
Date: 12/22/2009
Comment:

I believe that CMS should approve broad coverage of NaF-18 bone imaging because:

1. It is a bone scan and should be covered
2. The literature supports NaF PET bone scanning and in fact, shows that it is more accurate than traditional bone scans
3. Patients need access to an alternative to Tc-99m based bone scans because the supply of molybdenum has been problematic for the last two years and this could continue through 2010. It has been difficult to get

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Williams, Scott Date: 12/22/2009
Comment:

Men’s Health Network (MHN) appreciates CMS’s proposed coverage with evidence development for 18F-NaF. However, we considerately request that CMS extend full coverage to 18F-NaF for PET. We also request that CMS issue a final national coverage decision as soon as possible, to facilitate patient access to critical PET scans. PET scans are a critical component in the development of treatment programs for cancer patients with suspected bone metastases.

MHN is concerned about the negative

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Lee, Christopher Date: 12/22/2009
Comment:

1. CMS should approve broad coverage of NaF bone imaging because:

- it is a bone scan and should be covered
- the literature supports NaF PET bone scanning and in fact, shows that it is more accurate than traditional bone scans
- patients need access to an alternative to Tc-99m based bone scans because the supply of molybdenum has been problematic for the last two years and this could continue through 2010

2. If NaF

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Anderson, Peter Title: Professor
Organization: MD Anderson Cancer Center
Date: 12/22/2009
Comment:

As an expert in treatment of bone sarcomas and bone metastases, NaF PET would be a welcome and extremely useful study. It would for the first time provide quantitative instead of qualative data concerning osteosarcoma and Ewing''s sarcoma primary and metastatic disease - and also permit much better decisions to be made concerning both chemotherapy options and local control strategies. I would Strongly Encourage the adoption of very Broad coverage for both work-up, treatmetn evaluation and

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Lavely, William Title: Owner
Organization: Southern Molecular Imaging, LLC
Date: 12/21/2009
Comment:

1. CMS should approve broad coverage of NaF bone imaging because it is a bone scan that should be covered, the literature supports NaF PET bone scanning and shows that it is more sensitive and accurate than traditional Tc-99m bone scans and patients need access to an alternative to Tc-99m based bone scans because the supply of molybdenum has been problematic for the last two years and this could continue through 2010 and beyond.

2. If NaF is not broadly covered, then CMS should

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Carol, M.D., Mark Title: Chief Medical Officer
Organization: Alliance HealthCare Services
Date: 12/21/2009
Comment:

On behalf of Alliance HealthCare Services and its Alliance Imaging division, the largest provider of PET/CT services in the nation, we appreciate the opportunity to comment on CMS’s reconsideration of its coverage for NaF-18 PET/CT in connection with the identification of bone metastasis of cancer. As stated in our previous comments on the subject of expansion of Medicare coverage for PET/CT, we strongly encourage CMS to establish a coverage framework which ultimately relies on the

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Murphy RRT, Matthew Title: Radiology Technologist
Organization: Evergreen Hematology & ONcology
Date: 12/21/2009
Comment:

IN my experience with the NaF-18 bones, the NaF-18scans are better for the patents. The resolutionon the pictures are better then Tc bone scans. The NaF-18 scans can be put into several differentviews like axial,sagittal, coronal planes. It canalso put into a 3-D or MIP were the image can berotate 360 degrees. The Tc bone scan can only beviewed in two planes. The NaF-18 scan seems topick up more tumors then the Tc bone scan. Withthe better resolution, different planes to viewthe images

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Hartshorne, Michael Title: Professor of Radiology
Organization: UNM and NMVAHCS
Date: 12/21/2009
Comment:

I have been fortunate enough to run a Nuclear Medicine clinic at a VA hospital equipped with a state of the art PET-CT machine that I started to use for oncologic bone scans with F-18 about 2 years ago when a Tc-99m shortage started melooking for alternatives. Curiously enough the literature''''s justification for using F-18(Na)as a much superior agent (compared to the usual Tc-99m MDP bone scan)was there all along. I had read it. It just didn''''t register. When I did my first F-18(Na)

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Black, Richard Date: 12/21/2009
Comment:

The decision to approve F18 bone scintigraphy should be rather elementary. With the anticipated shortage of Tc on the horizon, and the superior count statistics achieved with F18 and consequent increased resolution and anatomic localization, the utilization of F18 bone scans on current generation PET scanners will provide for enhanced patient care and management. Having interpreted more than 1000 F18 bone studies, I have found that F18 bone scintigraphy is clearly superior to the results

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kipper, michael Date: 12/21/2009
Comment:

Dear CMS,

I would like to comment on the review of NaF-18 for bone metastases. I have had the opportunity to utilize Na-F in a select number of patients. As have others who have published, I found the images to be of superior quality to standard MDP studies, and was most impressed with the combination of PET and CT (for improved specificity). I support the approval of Na-F as an alternative to MDP for a number of reasons. First, the sensitivity and specificity with Na-F is much higher

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Iagaru, Andrei Title: Clinical Instructor
Organization: Stanford University
Date: 12/21/2009
Comment:

We used NaF-18 PET/CT for research purposes in the past 3 years at our institution and were impressed with the high quality of the images and the diagnostic accuracy of this imaging test. The published results of our studies confirm this. More importantly, our colleagues in Oncology used the information from these bone scans to change the management of their patients. At a time when the supply of Tc-99m MDP is unreliable, having the ability to better image the skeleton is a wonderful

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Miller, Darren Title: Center Director/Clinical PET Specialist
Date: 12/21/2009
Comment:

As the Clinical PET Specialist for several Florida based imaging providers I would like to express my support of PET bone imaging with NaF-18.

Frankly, it is long overdue. The technological benefits of PET over general Nuclear Medicine bone imaging (including SPECT) are clearly superior as documented in almost every clinical study. Unlike many other advances in imaging technology, PET bone imaging has few if any negatives:


1. Overall scan times are similar but the

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Messer, Guy Title: Owner & CFO
Organization: Trident Medical Imaging
Date: 12/16/2009
Comment:

As an owner and operator of three PET/CT centers (as well as a Nuclear Medicine Technologist), I can categorically state that the availability of F-18 in major metropolitan areas is more than adequate to accomodate the increase in utilization for F-18 PET Bone Scans. This in turn will greatly reduce the strained demands on nuclear medicine departments for Tc99m based scans including standard nuclear bone scans. In addition, numerous clinical journal articles have more than demonstrated an

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Christianson, Craig Date: 12/09/2009
Comment:

To make it clear to both requesting service providers and intermediaries which studies CMS has determined meet the clinical trial criteria to permit coverage, please consider providing a listing of qualified clinical trials that meet CMS criteria (e.g. from the National Clinical Trials database) in the final decision memorandum. Thank you.

Salvo, Vito Date: 12/04/2009
Comment:

What are the appropriate billing codes that should be used for PET NaF-F18 bone imaging?

Sheikh, Arif Title: Clinical Assistant Professor
Organization: The University of North Carolina
Date: 12/02/2009
Comment:

The study of NaF-18 in its efficacy of lesion detection is an appropriate study to perform as decided by CMS. However, additional issues must be considered in the unique uses of this type of study; namely, that aside from its broad use as a diagnostic tool, this tool should also be strongly considered for certain ''niche'' applications for which this may be the ONLY or BEST tool to use. Some applications to consider are as follows, but by no means are the only ones:

1) Dual tracer

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Jenkins, Thomas Date: 12/01/2009
Comment:

I support NaF PET bone coverage.