Positron Emission Tomography (FDG) for Cervical Cancer

September 11, 2009

Tamara Syrek Jensen, J.D.
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd., Mail Stop C1-09-06
Baltimore, MD 21244

Re: Comments on Proposed Decision Memorandum for Positron Emission Tomography (FDG-PET) for Cervical Cancer (CAG-00181R2)

Dear Acting Director Jensen:

The Society of Gynecologic Oncologists (SGO) thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to comment on the proposed decision memorandum regarding Medicare coverage of Positron Emission Tomography (FDG-PET) for the initial staging of cervical cancer.

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

We would like to voice our strong support for the proposed decision memorandum, CAG-00181R2, which proposes to cover FDG-PET for staging in beneficiaries who have biopsy-proven cervical cancer and remove the current restrictions on the coverage of FDG-PET imaging for the initial staging of cervical cancer. We appreciate CMS’ thoughtful review of the clinical evidence and the evidence from the National Oncologic PET Registry (NOPR).

As noted in our earlier letter, SGO believes that by eliminating the existing coverage restrictions on FDG-PET for the initial staging of cervical cancer, CMS will help SGO members to provide their patients with cervical cancer individually-tailored initial treatment strategies because SGO members will now be able to utilize the full range of imaging and other tools necessary to evaluate their patients and their cancers. In our previous letter, we mentioned numerous studies that support the conclusions that CMS has iterated in its proposed decision memorandum. One study warrants repeating, as CMS’ proposed decision memorandum directly addresses the findings and provides a remedy for the situation demonstrated by the study. Published in May 2009 in Gynecologic Oncology by Dr. NT Kizer, et al, the study found that despite clear scientific data supporting the use of PET/CT in patients with cervical cancer and its apparent widespread availability, this imaging modality remains highly underutilized in part because of the need to clarify insurance coverage early in the evaluation process. Adoption of this proposed decision memorandum will provide the needed clarity of insurance coverage for Medicare beneficiaries, and hopefully private insurance will follow Medicare’s lead.

Finally, we completely agree with the proposed decision memorandum that cervical cancer is diagnosed through biopsy as opposed to imaging, and thus we fully support the decision by CMS to not cover the use of FDG-PET for the diagnosis of cervical cancer.

SGO appreciates the opportunity to comment on the proposed decision memorandum and would be pleased to provide CMS with any additional information that may be of interest. Should you have any questions, please feel free to contact Jill Rathbun at 703-486-4200. Thank you for your consideration of our comments.

Sincerely,

Carol L. Brown, MD, Co-Chair, SGO Government Relations Ctme.

Monique Spillman, MD, Co-Chair,SGO Government Relations Ctme.

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September 11, 2009

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

Dear Ms. Jensen:

The Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), appreciates this opportunity to comment on the Center for Medicare and Medicaid Services'(CMS) Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Cervical Cancer (CAG-00181R2) (the "Proposed Decision"). As the leading trade association representing companies whose sales comprise over ninety five percent of the global market for medical imaging and radiotherapy, we have an indepth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides. MITA looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

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

In the Proposed Decision, CMS announces that it "proposes to cover only one FDG PET for staging in beneficiaries who have biopsy proven cervical cancer when the beneficiary's treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

Under CMS's current coverage policy, FDG PET is covered "for the detection of pretreatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis." All other uses in the initial treatment strategy are subject to CED. In other words, the patient must undergo a CT or MRI for extra-pelvic metastasis before the PET will be covered, and if the CT or MRI finds metastatic disease, the PET is subject to CED. Among the cancers for which Medicare covers PET without evidence development, cervical cancer is the only disease that has this requirement.

MITA is pleased that CMS proposes to end the prospective data collection requirements for FDG PET for certain purposes related to the initial treatment strategy for cervical cancer. MITA appreciated CMS's efforts to work with stakeholders to analyze the use of PET in clinical care decisions. The National Oncologic FDG PET Registry (NOPR) that was created to collect data under the current NCD has provided CMS with valuable information on the use of PET. The NOPR data on 22,975 patients indicate that physicians changed their intended management in 36.5 percent of cases after FDG PET was performed. For cervical cancer patients, changes in treatment were noted in 36.1 percent of cases. Based on its review of NOPR and other recent studies, CMS correctly concludes that "results of FDG PET imaging provide clinically meaningful information about the initial stage of the tumor and that this information is used by the treating physician to determine the appropriate initial antitumor strategy."

We agree with this conclusion, and we urge CMS to implement its proposal to cover, without evidence development, for FDG PET for certain purposes related to the initial treatment strategy for cervical cancer. Lifting the CED requirement for cervical cancer staging will improve access to appropriate care and reduce the administrative burden on physicians and providers. By allowing patients to receive FDG PET for initial staging without undergoing CT or MRI first, the requested coverage decision would help patients have their cervical cancer staged and begin treatment planning in a timely and efficient manner. It also would streamline reimbursement for providers and would simplify Medicare's coverage policy in general by allowing coverage for staging of all cancers covered without evidence development under the current policy. MITA also believes that CMS should apply CED to a technology no longer than is needed to gather information that can support full coverage. Now that CMS has reviewed the evidence collected under CED and in other studies, it is clear that the time has come to end CED for this use of FDG PET, as it did for other uses of PET scans in April 2009. We hope that CMS will continue to work to develop a single NCD that addresses all uses of PET for cancer so that Medicare's coverage requirements will be easy for patients, providers, and contractors to understand.

CMS also proposes to not cover FDG PET for the initial diagnosis of cervical cancer. The agency concludes that "there is no credible evidence that the results of FDG PET imaging are useful to make the initial diagnosis of cervical cancer, and therefore do not improve health outcomes, and thus are not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act." We agree that FDG PET is not necessary for diagnosis of cervical cancer.

We appreciate this opportunity to submit these comments and urge CMS to move forward with the recommended expansion of coverage of FDG PET. If you have any questions or would like to discuss these matters further, please contact me at 703-841-3279. Thank you for consideration of these comments.

Respectfully submitted,

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September 12, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Ms. Syrek Jensen,

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) national coverage decision (NCD), Positron Emission Tomography (FDG) for Cervical Cancer (CAG-00181R2). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
AHIP members support CMS's intent to ensure that all patients receive the most effective care and appropriate treatments based on the strength of the clinical evidence. Our members are in agreement with the external requestors' (including the National Oncologic PET Registry (NOPR) Working Group) call for CMS to revise the national coverage determination (NCD) for positron emission tomography (PET) for cervical cancer to guide initial staging of this disease.

Currently, the available evidence strongly suggests that PET FDG for solid tumors has the ability to differentiate metabolism of normal and abnormal tissues and that results of this testing can influence treatment options and improve outcomes for patients with cervical cancer. In addition, there is adequate evidence to demonstrate that the use of PET for the staging of diagnosed cervical cancer can positively impact prescribed treatment or enhance patient outcomes. During their August 2008 meeting, CMS's Medicare Evidence Development & Coverage Advisory Committee (MedCAC) articulated similar conclusions regarding the use of PET for cervical tumors. Cervical cancer received the highest vote of confidence (3.86 out of 5.0) for the reviewed solid tumors concluding that the evidence is adequate that FDG-PET imaging improves physician decision making.

It is important to have reliable and rigorous evidence regarding each cancer type to determine whether the use of this technology improves both treatment decisions and patient outcomes. AHIP member plans strongly support CMS's proposed revision of national coverage determination (NCD) for the use of one PET study for the staging of cervical cancer as part of the initial treatment strategy. Additionally, CMS is encouraged to consider emerging evidence for each cancer type, including other stages or tumors associated with cervical cancer, in regards to the use of PET, recognizing the variable differences between types and stages of cancers and patient outcomes. It also is equally important to monitor the potential over-utilization and inappropriate use of this technology for all cancer types.

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

Sincerely,

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September 11, 2009

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen, JD
Acting 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 FDG Positron Emission Tomography to Guide Initial Management of Cervical Cancer (CAG-00181R2)

Dear Ms. Jensen:

The Association of Community Cancer Centers (ACCC) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed national coverage decision (NCD) on positron emission tomography (FDG PET) to guide initial management of cervical cancer.¹ We urge the agency to finalize its proposal to cover the use of FDG PET to help determine the appropriate initial treatment strategy for beneficiaries who have biopsy proven cervical cancer.

ACCC believes that the proposal to cover FDG PET only for biopsy proven cervical cancer is a valid proposal and agrees that this procedure can be effective in the following areas:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasiveprocedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.²

ACCC is a membership organization whose members include hospitals, physicians, nurses, social workers, and oncology team members who care for millions of patients and families fighting cancer. ACCC’s more than 900 member institutions and organizations treat 60 percent of all U.S. cancer patients when combined with our physician membership. We are often at the front line in fighting cancer and therefore have a unique perspective on how FDG PET affects patient care and often improves health outcomes.

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

Various stakeholders, with the support of CMS, established and maintained the National Oncologic FDG PET Registry (NOPR) to study the effect of FDG PET on clinical decision-making as part of an April 18, 2005 NCD.3 CMS required providers to submit data to a registry as a condition of coverage of the FDG PET. Some of the results of this study were published in a March 2008 issue of the Journal of Clinical Oncology.⁴

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

ACCC is grateful for CMS for its continuing efforts to allow access to FDG PET for an expanded list of cancers. Our members constantly search for tools to appropriately treat and manage cancer and should the clinical benefits of FDG PET continue to evolve, we hope the agency would continue to act quickly afford broader access to this important technology.

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

Sincerely,

cc: Louis Jacques, MD
Stuart Caplan, RN, MAS
Jeffrey Roche, MD, MPH

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On behalf of Alliance HealthCare Services and its Alliance Imaging division, the largest provider of PET and PET/CT services in the nation, we appreciate the opportunity to comment on CMS’s proposed decision memorandum regarding the expansion of PET and PET/CT coverage to include staging of cervical cancer. We strongly support and agree with the proposed determination to expand coverage for the use of PET and PET/CT imaging for cervical cancer staging thereby allowing treating physicians to make meaningful changes in therapeutic management and improve health outcomes.

The use of PET and PET/CT for staging in beneficiaries who have biopsy proven cervical cancer has been shown by numerous clinical studies to improve the quality and appropriateness of subsequent therapy.

As stated in our previous comments submitted in support of the expansion of coverage for PET and PET/CT, we strongly encourage CMS to establish a coverage framework which ultimately relies on the professional judgment of treating physicians to determine the appropriate use of PET and PET/CT without imposing unnecessary burdens or preconditions on such physicians’ ability to obtain Medicare coverage for their patients. The continued expansion of reimbursement coverage for PET and PET/CT will have a direct and positive impact on millions of American cancer patients.

Sincerely yours,

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We are writing in strong support of the Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memorandum for Positron Emission Tomography (FDG) for Cervical Cancer, CAG- 00181R2, which proposes to cover FDG PET (PET) for staging in beneficiaries who have biopsy- proven cervical cancer, and to remove the current Coverage with Evidence Development (CED) limitations on the use of PET for the initial staging of cervical cancer.

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

We applaud the proposal to align coverage of PET for cervical cancer with the new omnibus PET National Coverage Decision (NCD) CAG-00181R, released earlier this year. As we noted in our initial May 29, 2009 comments in support of this request, coverage for PET imaging for cervical cancer is currently predicated on a prior CT or MRI that is negative for extrapelvic metastatic disease. This additional step of requiring a prior CT or MRI before authorizing PET coverage is unique to cervical cancer — indeed, we noted that no similar prerequisites exist for obtaining Medicare coverage for the use of PET for initial staging of other covered cancers under the omnibus NCD. Moreover, we observed that requiring CT or MRI prior to PET for cervical cancer initial treatment ignores the fact that the vast majority of PET studies performed in the United States are PET/CT studies The proposed decision would eliminate this anomaly in coverage, affording beneficiaries easier access to this important imaging technique without the imposition of additional inconvenience, unnecessary radiation exposure, and further expense.

We are also pleased to learn from the proposed decision that the CMS internal technology assessment confirms that the existing literature, the data from the NOPR, and the University of Alberta technology assessment all offer strong clinical evidence for the utility of PET for initial staging of cervical cancer.[1] As we stated in our initial comments, this literature indicates that almost all patients who receive a CT or MRI of the pelvis that shows no extrapelvic metastatic disease will still require PET in order to develop an initial treatment plan. Additionally, it indicates that PET will generally be necessary to enable a treating physician to assess the supraclavicular nodes when CT or MRI shows para-aortic nodal involvement (the most common site of extrapelvic metastatic disease). Moreover, it indicates that relying on negative conventional imaging as the basis for performing PET ignores the fact that PET is both more sensitive and more specific than CT or MRI for detecting pelvic and para-aortic nodal metastasis. We believe that the proposed decision accurately reflects the acknowledged limitations of the current PET coverage for cervical cancer (as identified in the literature), and that the proposed coverage determination responds appropriately to these limitations by authorizing PET coverage for initial staging purposes.

Besides eliminating the requirement for a prior CT or MRI, the proposed decision also takes the additional positive step of removing the CED requirement. As we noted in our initial comments, the data collected by the NOPR over the past two years provides strong supporting clinical evidence for this proposal. In specific, the NOPR data indicate that the percentage of the 341 cervical cancer patients who saw a “change in management” due to the use of PET was 36.1%, a similar percentage as the overall “change in management” percentage (39.8%) for all initial staging studies included in the NOPR.[2] Having served its intended purpose — providing quantifiable data to inform the proposed coverage decision — we now believe that the proposal to terminate the CED requirement as to cervical cancer is eminently justifiable.

Finally, we continue to agree with the conclusion reached by CMS in the omnibus NCD CAG-00181R (and again in this proposed decision) that, as cervical cancer is diagnosed primarily via biopsy, a decision to nationally non-cover the use of PET for the diagnosis of cervical cancer is appropriate.

The proposed decision will provide numerous benefits to patients and providers alike. It will remove an additional and unnecessary barrier to the use of PET for the initial staging of cervical cancer, enable CMS to harmonize the omnibus coverage policy for the use of PET across all covered cancers, accelerate the initial staging (and thus subsequent treatment planning) processes for patients, simplify the data collection burden of the NOPR, and streamline the reimbursement of providers for PET services rendered. We strongly support the proposed decision, and appreciate the opportunity to provide comments to CMS in this regard. We look forward to working with CMS to provide any additional information that you would find valuable in your decision making process.

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