Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used Anticancer Treatment

On behalf of MedImmune, a biotechnology company headquartered in Gaithersburg, Maryland, we thank CMS for the opportunity to comment on this issue. MedImmune manufactures one drug that is used to help cancer patients through the rigors of radiation therapy and or chemotherapy. We also have several anti-cancer candidates in our pipeline.

We agree with the agency that it is important to consider the most up to date literature when evaluating medically accepted indications for drugs and biologics used in anti-cancer treatments. Therefore, we would like to express our support of the May 4, 2006, letter to the agency from the American Society of Clinical Oncology.

We also believe that the following publications meet the same stringent criteria of peer review and respectability within the profession, and ask that you consider them as additions to the CMS list.

Thank you again for the opportunity to comment on this very important issue. Please contact me at 301 398 4626 if you have questions about this comment.

Best regards,
/s/
Brian Abraham
Associate Director, Reimbursement
MedImmune

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The American Society of Clinical Oncology (ASCO) appreciates the opportunity to comment on medical literature that could appropriately support contractor decisions to reimburse under Medicare for medically appropriate off-label uses of cancer drugs. The decision by the Centers for Medicare & Medicaid Services (CMS) to seek input on this question is timely and necessary to fulfill Congressional intent that contractors have access to reliable medical literature when making decisions about coverage of off-label uses for cancer drugs.

We have reviewed the comments submitted on this matter and believe that some of them identify other reasonable candidates for inclusion in the list of peer-reviewed journals that might offer guidance to contractors. ASCO is particularly interested in the supportive care journals that several commenters referenced, as we agree that supportive care has been an overlooked but very important segment of cancer care in this country. CMS should give careful consideration to inclusion of one or more supportive care publications.

While we endorse some of the additional suggestions for included medical journals, ASCO is concerned about the restrictive impulse reflected in other comments that would seek to limit the journals upon which contractors could rely in covering off-label uses of cancer drugs. In particular, the comments submitted by the Center for Science in the Public Interest (CPSI) seem not to appreciate the context in which § 1861(t)(2) of the Social Security Act was enacted.

In the 1993 legislation, Congress sought to address a pervasive problem of denials of reimbursement by Medicare for off-label (or unapproved) uses of cancer drugs when those uses in fact represented the standard of care for many cancers. Accordingly, Congress created a mechanism under which the coverage decision was taken away from Medicare and its contractors in favor of reliance of independent medical compendia referenced in the statute. At the same time, Congress sought a system that would be flexible and forward-looking so that coverage decisions could be based on reliable evidence-based information even before the compendia had acted. Medicare contractors were thus authorized to extend coverage to off-label uses of cancer drugs where such uses were supported by clinical trials as reported in high-quality peer-reviewed medical journals.

In light of the expansive spirit of the 1993 legislation, the best way to identify those journals is through the considered opinion of the physician specialists who treat patients with cancer. It is for that reason that the existing list of journals was developed by CMS in conjunction with input of expert opinion from ASCO members. That list has served the system well but is now in need of expansion, as reflected in ASCO's communications with CMS in 2003 and 2006.

CSPI has urged that the list of medical journals be limited in two respects—first, that no journal be included that has not subscribed to a requirement of clinical trial registration; and second, that no journal be included that does not disclose conflicts of interest. In the abstract, ASCO agrees that these two criteria are among the appropriate indicia of quality in scientific or medical journals, but they are not the only significant criteria, and they should not be utilized to foreclose otherwise appropriate coverage. For purposes of the Medicare law, which sought to expand patient access to off-label uses of cancer drugs, use of these narrow criteria to restrict patient access to potentially life-extending therapies is inconsistent with Congressional intent.

The criteria urged by CSPI involve important, but still evolving, guidelines for medical publications. The requirement of registration of clinical trials as a precondition for publication surfaced several years ago, and most medical journals are moving toward acceptance of this requirement. The details of compliance remain to be resolved, however, and it is by no means clear what the final contours will entail, probably several years hence. Significantly, several legislative proposals—with different criteria for compliance—have been introduced, with the outcome to be determined in the next Congress, if then. It would be imprudent to draw bright lines for compliance with clinical trial registration requirements at this premature stage in the development of this policy.

The same is true for disclosure of conflicts of interest. As with clinical trial registration, disclosure of conflicts of interest is viewed extremely favorably by ASCO, and in fact ASCO has long required such disclosure in its publications and other activities. It is important to recognize, however, that different journals are in varied stages of development in incorporating these standards, and patient access to life-extending therapies should not be jeopardized because some journals have not yet brought their practices into line with the latest thinking on these matters.

ASCO also disagrees with the suggestion from Trailblazer's Medical Director that Journal Impact Factor (JIF) be a decisive consideration in selecting journals for coverage purposes. Such a consideration would work well for journals like ASCO's Journal of Clinical Oncology, but would not be appropriate for journals dealing with orphan diseases like various blood cancers or with other relatively targeted sub-specialty interests that might be cited less frequently simply because of the smaller numbers of patients and treating physicians. The impact of medical journals cannot be measured solely in the numbers of citations they accumulate. Like the suggestion of CSPI, Trailblazer's recommendation is too formulaic to take into account the quality of the peer review and the nature of the clinical research being reported in the journal's pages.

In general, ASCO believes that the historic approach by CMS, relying on the judgment of physician thought leaders, has worked well. The application of external criteria not directly related to the quality of the clinical research—registration requirements, strong conflicts rules or journal impact factor—is off the point of the 1993 legislation, which was to expand and ensure patient access to medically appropriate cancer therapies, regardless of whether they are explicitly approved by the Food and Drug Administration. We urge CMS to adhere to the spirit as well as the letter of the 1993 legislation and allow science, medicine and clinical judgment to guide the development of the list of medical journals for the purpose of implementing § 1861(t)(2).

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On behalf of my fellow senior editors, our section editors and editorial board, we are pleased to reply to the CMS posting entitled: “Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used for Anticancer Treatment.”

In response to this invitation, we respectfully submit that The Oncologist journal should be added to the list of accepted medical journals in accordance with chapter 15, section 50.4.5 of the Medicare Benefit Policy Manual.

Mission, Impact and Global Audience

The Oncologist® was founded twelve years ago by leading experts in oncology as a peer-reviewed communications platform for surgical, radiation, and medical oncologists focusing on: 1) the introduction of new medical treatments and technologies that impact the practice of oncology, 2) bridging clinical trials with community practice, and 3) helping physicians better manage their practices in a changing and challenging environment.

Indexed by Index Medicus since its inception, the Journal is further distinguished by its ISI Thompson Impact Factor of 5.134 (2005), placing it among the world’s top peer-reviewed cancer medicine journals.

The global readership of The Oncologist’s US and European print editions is 21,500.

Peer-review Policy

The Oncologist abides by a rigorous policy of impartial anonymous peer review (see: http://theoncologist.alphamedpress.org/misc/ifora. shtml ). Manuscripts are critically reviewed for accuracy, validity, and reliability by unbiased independent experts. Publication decisions are made exclusively by the Editorial Board. The Journal abides by the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” published by the International Committee of Medical Journal Editors (ICMJE; http://www.icmje.org/index.html) which also affirms that editors have an obligation to publish negative studies as long as they are conclusive.

The Oncologist places a high priority on rapid publication. The peer-review process generally averages no more than 3 weeks; hence, the entire process, from manuscript acceptance to publication, takes ~3 months. When a contribution is of such relevance as to significantly impact public health, authors may request Fast Track Review for a Rapid Communication, in which case an editorial decision will be made within 2 weeks of submission.

An example of such a public health concern was the emerging observation of the use of certain bisphosphonates and the potentially serious, heretofore unrecognized complications of osteonecrosis of the jaw (ONJ). The Oncologist was the first major oncology journal to focus on this complication in its May issue, 2005. Please see:

Clinical trials registry

In accordance with the guidelines published by ICMJE, The Oncologist requires, as a condition for publication consideration, that all clinical trials be registered in a public trials registry (www.clinicaltrials.gov; www.icmje.org, Section III.J: “Obligation to Register Clinical Trials”).

Authors must comply with published CONSORT guidelines (http://www.consort-statement.org/). The completed checklist must be provided to the Journal’s editorial office along with the submitted manuscript.

Clinical trial registration and conflict of interest disclosure statements are included at the end of abstracts, as appropriate, enabling this information to be included in PubMed.

Scientific Integrity and Full Disclosure

Any potential conflicts of interests are resolvedvia The Oncologist’s anonymous peer review process. All information must be submitted, reviewed and found to be scientifically rigorous, based on the best available evidence, fair and balanced, and free of commercial bias.

Potential Conflict of Interest Disclosure Form All authors are required by The Oncologist to reveal any financial commitment or obligation with a company or its competitor who manufactures products that are discussed within the manuscript or with a company making a competing product. Additional relationships that might be considered competing interests, such as holding equity or paid consultancy, must be stated in the manuscript cover letter. All information concerning potential conflicts of interest will be kept confidential until provisional acceptance (and on file thereafter). Before the review of a manuscript begins, the authors are obligated to sign a Potential Conflict of Interest Disclosure Statement (http://theoncologist.alphamedpress.org/misc/TO_CO IDisclosure.pdf).

Medical Writing Assistance
All authors are required to disclose information about: 1) any assistance by a professional medical writer or editor in the preparation of the manuscript, and 2) whether one or more of the authors received payment or other compensation for writing the article. If a paper is accepted for publication, these facts are disclosed at the end of the published manuscript.

All articles in The Oncologist journal and CME supplements undergo the same stringent peer- review by the Journal's Editorial Board. The Journal’s Editorial Board is comprised of 8 Senior Editors, 53 Section Editors and 60 editorial board members, all of whom are internationally recognized experts in the field of oncology and all of its subspecialties.

During calendar year 2006, a total of 243 expert reviewers endorsed the publication of 149 papers that were printed in 1,141 pages that comprise Volume Eleven (2006) of The Oncologist.

Papers that are selected for subsequent CME consideration undergo an additional review by the CME Committee (please see below).

The Oncologist CME Online

The Oncologist CME Online Program for Enduring Materials is jointly sponsored by AlphaMed Press (the Journal’s publisher) and the National Institutes of Health/Foundation for Advanced Education in the Sciences (NIH/FAES), which is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing medical education for physicians and is responsible for general oversight of the educational objectives and adherence to the accreditation criteria (http://CME.AlphaMedPress.org/).

The Oncologist is the first and, to date, only peer-reviewed journal that provides CME accreditation in joint sponsorship with the NIH. In fact, during 2005, more than 70% of all CME credits awarded by the National Institutes of Health were to physicians enrolled in courses provided by The Oncologist CME Online.

The Oncologist is responsible for identifying the learning needs and interests of the participants. As Senior Editors of The Oncologist we first attested to this need and the value of CME at our Editorial Board meeting held May 14-16, 2001 and we are responsible for holding annual editorial board meetings that focus on CME initiatives. This we have done annually thereafter.

The Oncologist has, since February 2002, been making high quality, comprehensive CME in the areas of oncology readily and freely available over the Internet through an agreement with Stanford University’s HighWire Press, so that the largest possible target healthcare audience can be reached, including internationally based physicians as well as those in traditionally underserved areas.

The Senior Editors and the editorial board members of The Oncologist identify articles in each issue of the Journal and its supplements as educational courses for community-based oncologists and other medical personnel who wish to learn more about the diagnosis and treatment of cancer patients. In its continued effort to better address the needs of CME users, The Oncologist CME Online conducts Quality Assurance reviews of each course. The two-phase process consists of both a statistical and a medical review.

The National Cancer Institute of the NIH provides expertise in selecting and reviewing materials for The Oncologist CME Online and for quality assurance and continuing review of its online educational materials.

The two entities, The Oncologist Journal and the NIH, have a shared responsibility to make certain the educational program works to benefit cancer patients and to have a positive impact on the current incidence of cancer and outcome of cancer patients. Their common concern is to support health care professionals in their need to keep abreast of advances and changes in their field so that they have the opportunity to respond to them and so that patients feel confident that they are obtaining the very best standards of medical care.

CME course description The Oncologist CME Online provides a comprehensive collection of CME activities focused on a wide array of cancers as well as hard-to-find credits in, “risk management and supportive care.” More than 400 Category 1 CME courses listed by disease (http://cme.TheOncologist.com/cgi/hierarchy) are freely available 24 hours/day, 7 days/week. More than 35,000 Category 1 CME hours have been earned by physicians who have successfully taken these courses since February, 2002. For physicians, the online program provides a single resource for achieving credits which are essential to fulfill certain requirements for licensure. Additional information about The Oncologist CME Online is available: http://cme.TheOncologist.com/misc/cme_faq.shtml

Integrity of the CME Program
In compliance with the Standards of the Accreditation Council for CME, it is the policy of the NIH/FAES CME Committee to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities and to include information free of commercial bias and based on the best evidence available. All individuals in a position to influence the content of an activity have disclosed relevant financial interests or relationships of their own, their spouse/partner, or their worksite, with manufacturers or providers of commercial products, services, technology, or programs; and disclosed relationships with current non- governmental supporters of the activities. The faculty and planners have indicated that they have no relevant commercial relationships.

All information is submitted and reviewed and found to be scientifically rigorous, based on the best available evidence, fair and balanced, and free of commercial bias. All of the recommendations involving clinical medicine in the CME activities are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported or used in a CME course in support or justification of a patient care recommendation conforms to the generally accepted standards of experimental design, data collection and analysis.

The Commercial Support Standards also require that all CME courses give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. When it is necessary or helpful to use a trade name, then those of several companies are used, not just trade names from a single company. In the event that any discussion of unlabeled, investigational, or alternative use of a commercial product, device, or technique occurs in a CME course, a full disclosure is provided to the reader as well as a list of these items, their manufacturer and their use, on the author disclosure page.

For an example, please see:

Editorials and Critical Commentaries
Since The Oncologist reaches essentially all physicians in the United States who treat cancer patients, the Journal’s editorial board uses this powerful platform to share important editorials and critical commentaries of relevance to the practitioner.

FDA Commentaries
Every time a new drug or a new indication is approved by the FDA, the Agency submits a paper to The Oncologist for peer-reviewed consideration that gives, in addition to abundant other information, the pharmacology, along with the drug’s indication(s) and contraindication(s). These articles are, when peer-accepted, published under the Journal’s section entitled, “FDA Commentaries” For an example, please see:
FDA Drug Approval Summary: Erlotinib (Tarceva®) Tablets
MH Cohen, JR Johnson, Y-F Chen, R Sridhara, Richard Pazdur
The Oncologist, Aug 2005; 10: 461 - 466; doi:10.1634/TheOncologist.10-7-461
http://theoncologist.alphamedpress.org/cgi/content /full/10/7/461

Another example of how Commentaries have been used was the jointly authored Commentary by officers of the American Society of Clinical Oncology and the CEO Roundtable on Cancer, entitled, New Prescription Drug Benefit: The Role of the Oncologist. This 2005 paper informed physicians that on January 1, 2006, Medicare beneficiaries became able to access self- administered prescription drugs through prescription drug plans implementing the new Medicare Part D. This new benefit, “while clearly a positive development for cancer patients, introduces new complexity to the process of selecting and financing prescription drug coverage, so oncologists, like other physicians, should be prepared to advise their patients concerning options for coverage.” Dr. Mark McClellan, Administrator, Centers for Medicare and Medicaid Services, used this same issue of The Oncologist as his venue to add his supportive Commentary.

Both articles may be freely accessed in their entirety at:
New Prescription Drug Benefit: The Role of the Oncologist
Jointly authored by officers of the American Society of Clinical Oncology and the CEO Roundtable On Cancer
The Oncologist 2005; 10: 561-562; doi:10.1634/TheOncologist.10-8-561
[Abstract] [Full Text] [PDF]
http://theoncologist.alphamedpress.org/cgi/content/full/10/8/561

Help Your Patients Become Aware of the New Medicare Prescription Drug Plans
Mark McClellan
The Oncologist 2005; 10: 563-564; doi:10.1634/TheOncologist.10-8-563
[Full Text] [PDF]
http://theoncologist.alphamedpress.org/cgi/content/full/10/8/563

For all of the above outlined reasons we submit that CMS would be wisely exercising its judgment by including The Oncologist among accepted medical journals in accordance with chapter 15, section 50.4.5 of the Medicare Benefit Policy Manual.

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We are pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS) request for comment on the “Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used in Anti-Cancer Treatment.”

Pfizer is a research-based pharmaceutical organization dedicated to the discovery and development of innovative medicines and treatments to improve the quality of life of people around the world. We support CMS’ goal of promoting effective, high-quality care for beneficiaries. In addition, we support the development of policies that advance providers’ and Medicare beneficiaries’ access to life-saving medications and vital information about medically- accepted indications for approved medicines. We welcome the opportunity to continue our dialogue on these important issues.

The Medicare provisions in the Omnibus Reconciliation Act of 1993 (OBRA 93) specify requirements for coverage of medically accepted off-label uses of cancer drugs. Effective January 1, 1994, Medicare contractors are required to cover an off-label indication for a FDA-approved anti-cancer drug if the indication is listed in at least one of two approved compendia, or, in the alternative, described in at least one of 15 specific peer-reviewed journals.¹

Pfizer supports the continued use of medical literature as an adjunct to compendia for identifying medically accepted uses of anti- cancer drugs.

Cancer is a serious and life threatening diagnosis. Scientists and clinicians strive daily to identify new uses of medically accepted cancer drugs. They seek to report clinically significant findings in peer-reviewed literature as rapidly as possible. Even so, the elapsed time from manuscript development to acceptance by a designated peer-reviewed journal to publication in that journal to addition to a compendium can equal to or even exceed the predicted remaining lifespan of many cancer patients.

New treatments that may alter a beneficiary’s prognosis must be made available as quickly as possible. Medical innovation and improved therapeutic approaches develop at a rapid pace, especially in the area of cancer treatment. The information presented in peer-reviewed medical journals can be essential to optimizing patient care and quality healthcare delivery. Peer-reviewed literature provides a near- continuous flow of information to physicians that complements their clinical expertise and enhances their ability to help patients make informed treatment decisions.

We note that CMS has not added journals to the designated list of medical literature used to determine indications for off-label of cancer drugs since it was originally published in 1993. We encourage CMS to expand the number of designated journals by supplementing the list to include journals endorsed by the American Society of Clinical Oncology (ASCO) in 2003 and 2006.² The ASCO lists were developed through extensive consultation with leading physicians within ASCO and in additional oncology specialty societies. As a result, they have identified publications which provide the best clinical evidence on new uses of cancer drugs.

The number of scientists and clinicians engaged in cancer research and treatment has increased greatly since 1993. New respected journals have emerged in the past 13 years as well. Given the lethality of the disease and the importance of making new therapies available quickly, it is critical that CMS update the approved list of medical journals that may be used to determine medically accepted indications for approved anti- cancer drugs. Medicare beneficiaries, like other cancer patients, need access to state-of- the-art treatments.

While we acknowledge that this solicitation for public comment is only to revisit the list of journals used to make coverage decisions on the off-label uses of anti-cancer drugs, we believe that CMS should also consider expanding the list of recognized compendia. Currently CMS only supports two compendia that are still in publication.³ Both compendia and peer-reviewed journals are important vehicles for supporting beneficiary access to medically accepted cancer treatments.

We appreciate the opportunity to provide CMS with comment on the list of journals designated to determine medically accepted indications for new cancer drugs. Please feel free to contact me directly at 212-733-6973 with any questions, or if you need additional information on our above comments.

1 Centers for Medicare & Medicaid Services. Medicare Benefit Policy Manual Chapter 15, Covered Medical and Other Health Services, Section 50.4.5. Available at http://www.cms.hhs.gov/manuals/Downloads/bp102c15. pdf.

The CMS list of journals in Section 50.4.5 includes: American Journal of Medicine; Annals of Internal Medicine; The Journal of the American Medical Association; Journal of Clinical Oncology; Blood; Journal of the National Cancer Institute; The New England Journal of Medicine; British Journal of Cancer Care; British Journal of Hematology; British Medical Journal; Cancer; Drugs; European Journal of Cancer; Lancet; and Leukemia.

2 The ASCO2003 list includes: Annals of Oncology; Biology of Blood and Marrow Transplantation; Bone Marrow Transplantation; Cancer Investigation; International Journal of Cancer Care; Lancet Oncology; Gynecological Oncology; Lung Cancer; and The Cancer Journal. In addition to the 2003 list, the ASCO 2006 list adds: Clinical Cancer Research; Journal of the National Comprehensive Cancer Network; Journal of Thoracic Oncology; Breast Cancer Research and Treatment; and International Journal of Radiation Oncology, Biology, and Physics.

3 The two approved compendia are AHFS Drug Information and USP DI.

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The Oncologist's mission includes a basic commitment to CME. The target audience is the practicing oncologist be he or she a surgical, medical or radiation oncologist.

There is an extraordinary range of knowledge and expertise that's out there and the CME effort of The Oncologist is one of the major tools that exist which permit us to get at individuals' basic learning skills.

The field of oncology is particularly evolving quickly and continuously. This assessment is essential not only to physicians but also to patients. Heaven only knows just how hard it is to keep up today. I know that the Journal’s senior editors have worked exceedingly hard on this area (particularly Dr. Frank Balis), and it clearly shows in the final product.

The fact that the journal’s CME program is jointly sponsored by the NIH is further evidence of the exceptional quality of this effort. This fact is a powerful testimonial why The Oncologist ought to be added to CMS’s list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Eli Glatstein, M.D.
Vice-Chairman and Clinical Director
Department of Radiation Oncology
Hospital of the University of Pennsylvania
Philadelphia, PA 19104-4283

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From: Merrill Goozner
Director, Integrity in Science Project
Center for Science in the Public Interest
1875 Connecticut Ave., NW, Suite 300 Washington, DC 20009
202-777-8374
mgoozner@cspinet.org

Re: Medical Literature for Local Medical Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used in Anticancer Treatment

Thank you for the opportunity to comment on the proposed expansion of the number of journals that Medicare recognizes as acceptable outlets for published clinical trials that can be used to determine “medically accepted indications” for the off-label use of anticancer drugs and biologicals. The list of eight proposed by Dr. Joseph S. Bailes of the American Society of Clinical Oncology has serious shortcomings. Indeed, the list of 15 journals already in the Medicare manual has problems that the Center for Medicare and Medicaid Services should address. Allow me to explain. You list the following criteria that acceptable journals should follow:

I have reviewed the list of additional journals recommended to you by the American Society of Clinical Oncology. Several of these are highly respected journals that are new or have been re-named since the date of the last revision of your list. Based on my personal familiarity with these journals, I would recommend inclusion of Annals of Oncology, Clinical Cancer Research, Gynecologic Oncology, Journal of Thoracic Oncology, Breast Cancer Research and Treatment, and International Journal of Radiation Oncology, Biology, and Physics. For critical review of the important area of anticancer symptom management agents, I would also recommend Supportive Care in Cancer.Please note that these are my personal opinions and do not represent opinions of the Vermont Cancer Center or the University of Vermont.Please note that I am a member of the American Society of Clinical Oncology and of the Multinational Association of Supportive Care in Cancer.

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Community based oncologists are constantly barraged by new diagnostic and treatment modalities, non-textbook patient problems, and pseudo “breakthroughs.” How do you successfully interpret and integrate it all?

When it seems everything is on a need to know basis, The Oncologist tells us what we need to know. More pearls per page, painless CME credit, and practical help in our practice.

The Oncologist should, therefore, join the CMS list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Jayne Schlosser Gurtler, MD, FACP
Oncology & Hematology
East Jefferson General Hospital and Doctor's Hospital
Metairie, Louisiana

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Medicare contractors generally only use published articles for the determination of medically accepted indications for anticancer drugs after the FDA label and certain approved Compendia have been consulted. The current list of journals in the On-Line Manual is out-of-date and should be revised. I am in total agreement with Mr. Goozer of the Integrity in Science Project who suggests that any journal inlcuded on the list must have rigid policies regarding prior registration of clinical trials and conflict of interest disclosures.

In addition, I would suggest that CMS consider adding an additional criterion for inclusion based on the Journal Impact Factor as determined by ISI. Journals currently included on the list at 50.4.5 of the Benefit Policy Manual have an average Journal Impact Factor of 6.13 based on the 2003 JIF Report (the most recent I have available). Those proposed for inclusion had, in 2003, an average JIF of only 2.13 (several were not included in the 2003 report from ISI).

By adding this additional criteria, CMS could provide an additional level of assurance that this list of journals are generally recognized as reputable and authoritative.

I would be happy to speak with you about options for implementing such a criterion. At the very minimum, a journal is not included at all in the ISI JIF report, should not be considered for inclusion in this section of the Benefit Policy Manual.

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I have been delighted to be associated with "The Oncologist".

The general presentations within the journal are outstanding and it has been a pleasure to work with the Editorial Staff, who maintain the standard "par excellence".

"The Oncologist’s" CME on-line programme, I believe, reflects this excellence. It has been wide ranging, not only supporting CME credits in the every-day treatment of the various cancers, but also in the difficult to find areas of risk management and supportive care.

I have been particularly involved in Supportive Care of this, personally reviewed all the CME within the subjects and I believe that it does help support the healthcare professional in their need to keep abreast of advances and changes in their field.

In summary, I am delighted to give this testimonial on behalf of "The Oncologist" and endorse the proposal that the Journal be added to the list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

"The Oncologist" provides an outstanding peer-reviewed service.

Peter Harper, M.D.
Consultant Medical Oncologist
Guy's Hospital
St Thomas Street
London SE1 9RT

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I would like to comment on the development of The Oncologist and its contributions to continued medical education in our field.

As the Journal has grown in quality and maturity, its readership has expanded, and it is today one of the most widely read cancer journals in the world. This applies both to the print edition and to the online version.

As such, The Oncologist has the gravitas to be placed on the CMS list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Gabriel N. Hortobágyi, M.D., F.A.C.P.
Professor of Medicine
Chair, Department of Breast Medical Oncology
MD Anderson Cancer Center

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It is a pleasure to have the opportunity to express my views on the importance and the impact of The Oncologist.

The Oncologist journal has been an outstanding achievement and success. It and its CME program is one of the most exciting and invaluable educational initiatives ever undertaken by any international peer review medical journal.

This unique journal provides cancer practitioners and patients all over the world the opportunity to stay abreast of the latest developments in cancer care and cancer research. As a result The Oncologist is making sure that patients benefit from the latest advances in cancer care as soon as possible.

I hope that CMS takes the Journal’s international impact into account and that it will add The Oncologist to the list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Patrick Johnston, MD, PhD
Professor of Oncology
Director, Centre for Cancer Research and Cell
Biology
Queen's University Belfast
Belfast, Northern Ireland
Ph 44 2890263911
Fax 44 2890263744

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As Director of the Women's Cancer Resaerch Institute and the Division of Gynecologic Oncology at Cedars-Sinai and Professor of Obstetrics and Gynecology at the Geffen School of Medicine at UCLA, I strongly encourage CMS to add our flapship journal "Gynecologic Oncology" to its list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment. As an Associate Editor, contribiting author and consumer of this well-regarded journal, I can attest that it is the premiere clinical and scientific journal for the Gynecologic Oncology community which includes all oncologists who treat gynecologic cancers. It clearly meets the qualifying criteria for inclusion into your list including impartiality, rigorous peer-review process, required attestations of conflict, and authorative status in the discipline. If you have any questions in this regard, please do not hesitate to contact me.

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I want to record my unreserved support for the proposal to add The Oncologistto CMS’s list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

The Oncologist is a very strong, peer-reviewed journal with a clinical focus, featuring original clinical research, review articles, case studies, and discussions of ethical and humanitarian issues as they apply to cancer patients. I use the Journal regularly in dealing with my patients, and also utilize its powerful online search engine to find previous articles of interest.

For the past several years The Oncologist has offered an online CME program focusing on current topics in oncology. Although I always get many more yearly CME hours than is required, I regularly take the CME post-article CME test, not for the added credits, but to reinforce the learning objective, or more probably, as a holdover from the obsessive, competitive test-taking mentality of my youth. Moreover, The Oncologist’s online CME program fills a valuable educational niche for us practicing oncologists, thereby helping to assure appropriate care of our patients.

Dwight Kaufman, M.D., Ph.D
The Jackson Clinic
Jackson, TN

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Bayer Healthcare LLC (“Bayer”) submits the following comments in response to the notice posted on the Centers for Medicare and Medicaid Services “CMS”) website on October 27, 2006 announcing solicitation of comments regarding the use of certain medical literature by local Medicare contractors to determine medically accepted indications for drugs and biologicals used in anticancer treatment. We believe very strongly that CMS should include the publications suggested by the American Society of Clinical Oncology (“ASCO”) in the list of approved journals, and we suggest an additional publication for inclusion as well.

We are pleased to offer comments on this critically important issue. For more than 100 years, Bayer has produced high-quality drugs and biologicals that have helped patients lead healthier lives. Bayer produces drugs that treat prostate cancer and advanced renal cell carcinoma; and so, we are especially interested in working with CMS and the scientific community to establish reasonable coverage policies that provide appropriate and timely access to life- saving anticancer therapies.

Congress has mandated special rules for anticancer drugs that allow for coverage of off-label uses that are supported through rigorous research and publication within the scientific community. Section 1861(t)(2) of the Social Security Act (the “Act”) establishes special factors that local Medicare contractors must consider when defining a “medically accepted indication” for purposes of anticancer drug therapy coverage. Subsection (B) (ii) (I) of this section of the Act requires that local Medicare contractors consider as medically accepted those uses of anticancer drugs which are supported in recognized compendia. Subsection (B)(ii)(II) of this section also provides that local Medicare contractors consider as medically accepted, those uses of anticancer drugs that are “medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub clause by the Secretary.”

Taken as a whole, section 1861(t) (2) of the Act imparts a unique coverage policy for anticancer treatment that acknowledges the value of on-going clinical research within the scientific community and the importance of providing Medicare beneficiaries with timely access to appropriate anticancer therapies based on this research. Bayer fully supports CMS maintaining and overseeing a robust listing of recognized compendia and medical literature for purposes of this policy.

As directed by Section 1861(t) (2) (B) (ii) (II) of the Act cited above, the Secretary has established a list of fifteen peer reviewed journals in § 2049.4, C.4. of the Medicare Carriers Manual (Part 3) that Medicare contractors must review in determining medically accepted off-label uses of anticancer drugs. Bayer fully supports the request of ASCO to expand this list to include the following journals:

Annals of Oncology;
Biology of Blood and Marrow Transplantation;
Clinical Cancer Research;
Gynecologic Oncology;
Journal of the National Comprehensive Cancer Network;
Journal of Thoracic Oncology;
Breast Cancer Research and Treatment; and
Internal Journal of Radiation Oncology, Biology, Physics.

We additionally support adding Haematologica/The Hematology Journal to the list of approved journals. This is a highly regarded and widely indexed journal in the field of hematology and is the official journal of the European Hematology Association. This journal maintains strict submission standards and has an impact factor (as measured by the Institute for Scientific Information) on par with other highly regarded hematology-related journals, Blood, Leukemia, and the British Journal of Hematology which are currently included on the CMS list. We believe the addition of Haematologica/The Hematology Journal will provide a greater balance between solid tumor publications and blood-based cancer publications on the CMS list.

Bayer is committed to thorough study design and oversight that adheres to high scientific, medical, and ethical principles. Each of these publications is widely respected in the medical field for maintaining a high level of clinical integrity. These journals use a rigorous peer-review process to evaluate original research so that the best clinical evidence on new uses of anticancer drugs is presented in a transparent, timely, and scientifically-based manner. Bayer also believes that inclusion of specialty publications on the list of recognized journals will allow for more significant stakeholder participation in the process for determining appropriate Medicare beneficiary access to the latest anticancer therapies.

A substantial body of evidence- based, peer-reviewed medical literature is essential to the success of Congress’ policy of expanded access to appropriate anticancer therapies for Medicare beneficiaries. Along with appropriate oversight and expansion of the recognized compendia, Bayer believes that periodic evaluation and maintenance of the list of peer-reviewed medical journals will go far in promoting appropriate access to the most current uses of anticancer therapies. Accordingly, Bayer supports addition of these nine journals to the list of approved journals in § 2049.4, C.4. of the Medicare Carriers Manual (Part 3).

Adding these journals to the list of approved journals in the Medicare Carrier Manual will speed Medicare beneficiaries’ access to the latest advances in anticancer treatment, but only where appropriate support for coverage is present in recognized journals. We believe that this approach will balance the concerns regarding prompt access to treatment with the important concern regarding rigorous review of coverage requests.

With respect to the critical issues of coverage, Bayer wishes to emphasize again its support for the naming of an additional official compendia pursuant to the Secretary’s authority under § 1861(t) of the Act. Recent substantial delays in the compendia process have called into question the ability of the two remaining compendia publishers to respond to advances in anticancer treatment in a timely manner as envisioned by Congress. Though recognition of additional publications on CMS’ list of such publications is important, there is no substitute for the addition of another compendia in ensuring more prompt access to cancer therapies.

Thank you again for the opportunity to offer comments regarding the use of certain medical literature by local Medicare contractors to determine medically accepted indications for drugs and biologicals used in anticancer treatment. In summary, we fully support ASCO’s recommendation that the above cited eight journals be added to the list of approved journals in the Medicare Carrier Manual, and we support including Haematologica/The Hematology Journal in the list as well. We believe these additions will provide for a more robust body of scientifically- accepted, evidence-based scholarship upon which appropriate access to off-label uses of anticancer may be established for Medicare beneficiaries.

We appreciate your thorough review of our comments and would be happy to provide you with additional information at your request. We look forward to continuing to work with you to improve the health of Medicare beneficiaries and thank you in advance for your thoughtful consideration of our comments.

Sincerely,

Jeffrey S. Humphrey, MD
Vice President, US Medical Affairs Oncology
Bayer Healthcare

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On behalf of the American Cancer Society (“the Society”) and its millions of volunteers and supporters, we respectfully submit the following comments for your consideration regarding the Centers for Medicare & Medicaid Services’ (CMS’) solicitation for comment on the medical literature to be used by local Medicare contractors to determine medically accepted indications for the off-label use of drugs and biologicals used in anticancer treatment posted in the Medicare Coverage Database on October 27, 2006.

Under section 1861(t)(2)(B)(ii)(II) of the Social Security Act, Medicare recognizes a “medically accepted indication” for the off- label use of a drug or biological used in an anticancer treatment regimen if the carrier determines that the use is “medically accepted based on supportive clinical evidence in peer- reviewed medical literature appearing in publications which have been identified for purposes of this subclause by the Secretary.” The Medicare Benefit Policy Manual in chapter 15, section 50.4.5 lists 15 publications for this purpose.

The American Cancer Society recommends that the Journal of the National Comprehensive Cancer Network, along with the other journals recommended by the American Society of Clinical Oncology (ASCO), be added to the current list of approved publications. ASCO’s recommended publications provide the best clinical evidence on new uses of cancer drugs—they have significant scientific value and publish research only after a rigorous peer-review process.

The list of approved publications to be used in making determinations about new off-label uses of drugs and biologicals used in the treatment of cancer has the potential to save the lives of millions of Medicare beneficiaries diagnosed and living with cancer. Given the importance of off- label anticancer treatments—more than 60 percent of oncologists prescribe drugs for the off-label treatment of cancer patients—the Society appreciates the opportunity to provide you with comments on this publications list.

Daniel E. Smith Wendy K. D. Selig
National Vice President Vice President
Federal and State Government Relations
Legislative Affairs

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I am the Chief of Gynecologic Oncology, and a Professor of Obstetrics and Gynecology at UC Davis Medical Center. I strongly endorse that CMS add our flapship journal "Gynecologic Oncology" to its list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment. As a contributor to this well-regarded journal, as well as a member of the editorial board and a consumer of its content, I can attest that it is the premier scientific journal for the Gyn Oncology community which includes all oncologists who treat gynecologic cancers. It clearly meets the qualifying criteria for inclusion into your list including impartiality, rigorous peer-review process, required attestations of conflict, and authorative status in the discipline.If you have any questions, please feel free to contact me.

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I am writing to express support for the eight journals recommended in the American Society of Clinical Oncology (ASCO) May 2006 letter to CMS as additional publications that should be recognized by Medicare contractors for coverage of off-label drug uses.

Several of these journals are published by medical societies that are highly respected for their contributions in promoting cancer research and advancing treatment. All of these journals are well-recognized among oncologists nationally and internationally for publishing original research following a rigorous process of peer-review.

During the course of my own career as a radiation oncologist with a special interest in breast cancer, I have become personally familiar several of the titles recommended by ASCO, including the International Journal of Radiation Oncology, Biology, and Physics, the Annals of Oncology, Gynecologic Oncology, Clinical Cancer Research, and Breast Cancer Research and Treatment. These journals consistently present important and clinically relevant findings of high scientific integrity.

It is critical for Medicare beneficiaries with cancer to have access to appropriate off-label therapies. I would therefore urge CMS to update and expand the list of journals currently referenced for off-label drug uses to include additional definitive literature on cancer treatment as recommended by ASCO.

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The Upstate New York Society of Medical Oncology and Hematology supports the addition of the journals recommended by ACSO to the Carriers Manual. The ongoing Medicare demonstration project has emphasized the importance of the Nation Comprehensive Cancer Center (NCCN) guidelines in treatment of patients with cancer, yet some of these guideline treatments are not covered. The addition of the Journal of the National Comprehensive Cancer Network and the other journals listed will help to correct this awkward situation.

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MGI Pharma ('MGI') submits this comment in response to CMS's solicitation for comments on Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used in an Anticancer Treatment ('Solicitation'). MGI is an oncology and acute care-focused biopharmaceutical company that makes available products that address the unmet needs of patients in the United States.

The Solicitation concerns the list of peer-reviewed journals appearing in Section 50.4.5 of the Medicare Benefit Policy Manual. The Manual provision generally concerns the factors to be used in evaluating unlabeled uses of FDA approved drugs and biologicals used in anti-cancer chemotherapeutic regimens. Among other things, CMS recognizes a 'medically accepted indication' for the off-label use of a drug or biological used in an anticancer treatment regimen if the carrier involved determines that the use is medically accepted based on supportive clinical evidence in peer-reviewed medical literature appearing in publications listed in the Manual. The Manual provides that peer reviewed medical literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. The Manual currently lists 15 publications and has not been updated since it was originally established in 1993.

We understand that on at least two occasions, the American Society of Clinical Oncology ('ASCO') has recommended additions to this list. Most recently, ASCO submitted a letter to Dr. McClellan on May 4, 2006 requesting the addition of eight journals. ASCO made these recommendations based on consultation with physician leadership about which publications provide, in the physicians' views, the best clinical evidence on new uses of cancer drugs. We further understand that the Biotechnology Industry Organization ('BIO') suggested the inclusion of several additional journals in comments they submitted to CMS on this issue. BIO identified these journals based on its determination that the journals use a rigorous and unbiased peer review process before publication and provide a broader international scope to patient care.

MGI requests that CMS revise the list of publication in the Manual to include those journals recommended by ASCO and BIO. We believe that, after performing an independent review of the publications, CMS will determine that they meet the criteria for inclusion set forth in the Manual. The addition of these journals will enhance beneficiary access to the most current anticancer treatment regimens available.

Please do not hesitate to contact me if you have any questions regarding these comments. Thank you for your attention to this very important matter.

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Those who know me are well aware of just how strongly I believe in the "Mission" of The Oncologist journal which we started eleven years ago.

I am especially pleased that we, as senior editors, have been able to provide a powerful online opportunity for our readers to earn CME credits. All of us in the business of providing care for cancer patients are extremely busy and there are few minutes left in each day for the task of continuing our education maintaining the level of excellence expected and deserved by our trusting patients. The CME opportunity provided in The Oncologist allows our readers’ access to excellent peer reviewed articles on the latest approaches to treating specific cancers and of timely reviews to the science that underpins our therapies.

We the editors have provided for additional review of each selected article to be used in CME further insuring the highest of standards. Our CME option provides an opportunity to test ourselves to ensure our comprehension of the important information provided. This process of self-evaluation is a critically important contribution to our medical colleagues and ultimately to our cancer patients.

The vision and hard work of the Journal’s editors and editorial board continues to make The Oncologist an immensely valuable educational resource. We hope that CMS will take this into account as they review The Oncologist, for it belongs on its list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

John E. Niederhuber, MD
Director
National Cancer Institute

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Having been involved with The Oncologist for several years as a member of Journal’s Editorial Board, I have first-hand knowledge of the depth of commitment The Oncologist CME Editors and Editorial Board have to excellence and creativity in providing the best and most up-to-date information to oncologists to improve and support optimal patient care.

I have been particularly impressed over the years by the quality of The Oncologist Editorial Staff and the Editors and their total dedication to the mission of the journals and the Online CME efforts, namely to ensure that oncologists have the information they need to provide state-of-the-art care. Furthermore, the high quality of the Online educational programs, the depth of the topics and faculty and the attention to accuracy and fair balance are unparalleled in the field of oncology CME.

The Oncologist has my admiration and continued support for this highly successful and valuable program, and I hope that CMS will soon add the Journal to its list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Joyce O'Shaughnessy, M.D.
Co-Chair, Breast Cancer Research
US Oncology

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The eight journals submitted by ASCO are all superior peer reiviewed oncology journals that hold to the same standards as those journals CMS currently uses to determine medically accepted indications for drugs and biologicals. The addition of these 8 journals will allow CMS to be able to get the latest scientific and peer reviewed information so Medicare beneficiaries can receive the best cancer treatment. Many Medicare patients do access the internet to get the best and latest cancer treatment info as well as compare notes with other patients in my office. It is very difficult when I have to tell a Medicare patient that he/she cannot get the best current treatment because Medicare has not approved the drug(s) or biological(s) they need. Also, many of these newer treatments are more effective and less toxic than the older regimens. I personally as well as on behalf of the membership of the Medical Oncology Society of New Jersey strongly urge CMS to adopt all eight oncology journals requested by ASCO.

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The Oncologist has proven to be one of the fastest rising stars among oncology journals … if not the fastest. One just has to look at the Impact Factor of the Journal which it has been reached in a relatively short period. I can not name another journal that has proven its value as fast as The Oncologist. Nevertheless, in a field moving as fast as oncology, even the printed version of The Oncologist cannot fully meet the needs of the oncologists. More was needed.

The Oncologist Online and its CME program have proven to be the perfect compliment to the printed journal. No one could have predicted the major role and impact that CME programs would have on today's patient care. This Journal’s unique online format has succeeded in filling a daily educational need in oncology. With The Oncologist’s available at the tip of our colleagues' fingers worldwide, a unified dialogue on cancer patient care has been established. The Oncologist dramatically impacts our profession … it can’t be said any more plainly. Although the practitioner benefits, the ones who really benefit most from the Journal are our cancer patients. The outstanding quality of the articles and its CME courses amazes me, again and again. The editors consistently succeed in delivering a superb education product. My compliments to them! On behalf of my European colleagues who use this Journal and its CME daily please keep these superb educational programs going for the benefit of our cancer patients.

For all of the above, I encourage the CMS to add The Oncologist to its list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Professor H.M. Pinedo, M.D., Ph.D.
Founder
VUmc Cancer Center Amsterdam
Free University Hospital
AMSTERDAM, The Netherlands

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Surveys have demonstrated an increasing number of physicians using internet-based CME opportunities. The value of these opportunities ultimately will derive from their relevance, accessibility, and content presentation.

From this perspective, the CME Online program offered by The Oncologist is already a highly valued resource. The topics are drawn from recent peer-reviewed publications on topics of greatest interest to the oncology community. Access is simple and the program has the ability to reach a far larger professional audience in a shorter time than the published journal in print.

This high-quality program contributes to a national educational shift that holds the promise of disseminating clinically-relevant information to an ever-enlarging group of clinicians in remarkably short time frames. It deserves support as does the proposition that The Oncologist be added to the CMS list of approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Russell K. Portenoy, MD
Chairman, Department of Pain Medicine &
Palliative Care
Beth Israel Medical Center
New York, New York 10003

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The Alliance of Dedicated Cancer Centers:
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
City of Hope National Medical Center
Dana-Farber Cancer Institute
Fox Chase Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Roswell Park Cancer Institute
Seattle Cancer Care Alliance
Sylvester Comprehensive Cancer Center

December 22, 2006

By Electronic Delivery

LCDR Tara Turner, PharmD
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Medical Literature for Local Medicare
Contractors to Determine Medically Accepted
Indications for Drugs and Biologics Used in Anticancer Treatment

Dear Ms. Turner:

On behalf of the Alliance of Dedicated Cancer Centers (ADCC), an alliance of ten nationally recognized institutions providing state-of-the-art care for cancer patients, I am writing in response to the Centers for Medicare and Medicaid Services’ request for comments on the list of publications that can be used by Medicare contractors to determine Medicare coverage for new anticancer treatments.¹

As you know, Medicare currently recognizes a “medically accepted indication”² for the off-label use of a drug or biological used in an anticancer treatment regimen if a contractor determines that the use is “medically accepted based on supportive clinical evidence in peer-reviewed medical literature appearing in publications which have been identified … by the Secretary.”³ CMS currently lists 15 such publications in its Medicare Benefit Policy Manual.⁴ This list has not been revised since it was originally promulgated in 1993. We strongly support adding, at a minimum, the following peer-reviewed medical journals to this list:

Significantly, some Medicare contractors already recognize publications in addition to those on the current list for purposes of making local coverage determinations.⁵ For the sake of achieving uniformity in Medicare coverage and to ensure that Medicare beneficiaries can obtain access to many innovative life-saving therapies, we urge CMS to expand the list to include the above-referenced publications.

The Alliance also recommends that CMS consider adding certain qualified abstracts to the list of approved publications. We recognize that, under current CMS policy, abstracts are not included in the definition of “peer-reviewed medical literature.”⁶ However, CMS coverage policies should recognize that the speed with which medical information is disseminated in today’s clinical environment now far surpasses the speed of the publication process. As a recent example, bevacizumab for both breast and lung cancers was presented in abstracts in May of 2005 showing survival benefits in large, randomized trials, yet as of this date 19 months later no manuscripts have been published. In order for third-party payers to be fully responsible to their patients, a mechanism should exist for allowing high-quality material to be considered, even if it is in abstract form. To ensure the quality of the material presented, the Alliance recommends that an abstract be included in the list of acceptable publications only if it meets the following criteria:

Significantly, abstracts are often the only form of published evidence that apply to those diseases that are rare, have small patient populations, and have limited treatment options. Because of the small numbers, it is not feasible for pharmaceutical companies and research facilities to conduct large multi-center clinical trials. Clinical research in these cases is often limited to small specialty groups within research facilities that treat these patient populations. The results of this work are then summarized and presented to professional societies, but not always submitted for publication, or are not accepted for publication because they do not meet journal requirements.

We commend CMS for considering expanding the list of approved publications and appreciate the opportunity to comment on this important issue. If you have any questions or require additional information, please contact the Alliance’s consultant on these matters, Dr. James Dougherty of the Arcus Group, LLC, at 212.785.2236.

Sincerely,
/s/
James S. Quirk
Executive Director
Alliance of Dedicated Cancer Centers

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Berlex appreciates the opportunity to provide comment on the list of peer-reviewed medical journals described in Chapter 15, section 50.4.5 of the Medicare Benefit Policy Manual, for use by Medicare contractors to determine medically accepted indications for drugs and biologicals used in anticancer treatment. Berlex, a U.S. affiliate of Schering AG, Germany, is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovative treatments in the areas of female health care and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. For the past twenty-five years, Berlex has worked to make important therapies available to Medicare beneficiaries.

Berlex supports ASCO’s letter of May 2006 and the need to update the existing list of approved medical journals. We are particularly concerned with ensuring an adequate representation of literature related to the treatment of hematologic diseases. Medicare beneficiaries make up the majority of hematology patients, with a median age at diagnosis of 67 years for patients with non-Hodgkin’s lymphoma (NHL) and leukemia, and a median age at diagnosis of 70 years for myeloma patients.(1) To continue to provide Medicare beneficiaries with access to the latest treatments in hematology, Berlex recommends that the following journal be added to the current list of publications:

Haematologica/The Hematology Journal is the official journal of the European Hematology Association (EHA), which is a major congress in the field. The journal is indexed in Index Medicus/Pubmed, EMBASE and Current Contents, and has become increasingly visible over the last few years with a rejection rate of approximately 65%. It’s 2005 impact factor of 4.575 (as measured by the Institute for Scientific Information) gave it a ranking of 10/60 in the Hematology category, making it comparable to other highly regarded journals in this field, such as Blood (2005 impact factor = 10.131), Leukemia (2005 impact factor = 6.612), and British Journal of Hematology (2005 impact factor = 4.080). The editorial policy according to the journal’s website (http://www.haematologica.it/) “requires authors, reviewers and editors to declare any potential conflict of interest. In addition, the journal itself will disclose any financial relationship with advertising clients and sponsors.”

We believe this journal would be an appropriate addition to the current CMS and ASCO lists, based on the CMS criteria of having “a rigorous impartial peer review process, lack of publication bias, full and timely public disclosure of potential conflicts of interest of authors, reviewers and editorial staff, reputation for scientific integrity and authoritative stature in the field of cancer treatment.”

Thank you again for providing an opportunity to submit comments on this topic. If you have any questions or require additional information, please contact our Oncology Reimbursement Manager, Jennifer Levin at 973.305.5304.

Sincerely,

Andrew Sandler, MD
Executive Director and Head of Central Medical
Affairs Oncology

(1) Ries LAG, Harkins D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L, Eisner MP, Horner MJ, Howlader N, Hayat M, Hankey BF, Edwards BK (eds). Table I-11, Median Age of Cancer Patients at Diagnosis, 2000-2003. SEER Cancer Statistics Review, 1975-2003, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2003/, based on November 2005 SEER data submission, posted to the SEER web site, 2006.

(2) This journal is published in Italy by Ferrata Storti Foundation; which in 2005 absorbed The Hematology Journal from the Nature Publishing Group and combined it with Haematologica (which has been published in Italy since 1920).

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Thank you for the opportunity to comment on “Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used for Anticancer Treatment.” The journals proposed by the American Society of Clinical Oncology are exemplary publications and deserving of being added to the Medicare Benefit Policy Manual.

However, it is our belief that the perspective of the private oncology practitioner should also be added, as represented by the peer-reviewed Elsevier journal Community Oncology. In the United States, community oncologists have transformed cancer care from an inconvenient hospital-based delivery system to an outpatient, office visit experience. This shift from highly specialized and centralized academic centers to the community means that patients can find an oncologist virtually anywhere in the country. And the rise of satellite offices allows even the smallest communities in sparsely populated areas to have access to local cancer care. As a result, more than 80 percent of cancer patients today are treated by private practice community oncologists, and more than 60 percent of adult patients in clinical trials participate through their community oncologist’s office. The greatest impact on cancer patients is felt in these community practices.

Most community practitioners trained at major academic centers of excellence. Currently, there are more than 5,000 community oncologists practicing in the U.S., along with more than 25,000 affiliated healthcare providers such as oncology nurses, nurse practitioners, physician assistants, oncology pharmacists, oncology social workers, and practice administrators.

As independent caregivers, these clinicians are responsible for offering quality care while translating new data into clinical practice. Our more than 30,000 readers look to the journal Community Oncology for the leading edge of these decisions.

Since we began publishing three years ago, Community Oncology has focused on providing practical information that enhances our readers’ ability to deliver quality care. The cornerstone of our journal is Community Translations, a section that presents summaries of new findings in both community and academic research and places them in context of private practice. Perspectives are offered by oncologists, oncology nurses, and practice administrators. From readership feedback we know that these comprehensive reviews are particularly helpful because they bear directly on Medicare reimbursement. Many purely academic articles focus on a specific research report, but the reviews in Community Oncology both express and extend that point of view to practical matters.

Our other key areas of focus are research conducted in the community, the treatment of challenging cases and rare cancers, and management of side effects.

Quality of cancer care in the community setting is a heretofore unexplored area in the medical literature and outcome data proving quality is a crucial aspect of what we publish. Part of improving quality derives from usable, realistic, and specific community oncology-based practice guidelines. The journal serves as a forum on best practice approaches. Little has been published on how we can work toward improving care, making Community Oncology of vital importance to our readers.

Upon receipt of manuscripts, we each perform an initial review. If the paper passes this first gate, it is sent to a minimum of two reviewers recommended by one of us or the managing editor for a rigorous single-blind review. We ask reviewers to indicate whether the material is original, the data valid, conclusions reasonable, information important, writing clear, of general medical interest, the tables/figures appropriate. We also ask reviewers to disclose any conflicts of interest in reviewing the manuscript and for specific comments on the text. Final decision on acceptance rests with the Editor-in-Chief.

All submissions to Community Oncology must include disclosure of all relationships that could be viewed as presenting a potential conflict of interest. The Editor may use such information as a basis for editorial decisions, and will publish such disclosures if they are believed to be important to readers in judging the manuscript.

At the end of the text, under a subheading "Conflicts of Interest," all authors must disclose any financial and personal relationships with other people or organizations that could inappropriately influence (bias) their work. Examples of financial conflicts include employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications, and travel grants within the past 3 years. The corresponding author is asked to state whether he or she has had full access to all the data in the study and has had final responsibility for the decision to submit the paper for publication.

Currently, Community Oncology is indexed in EMBASE and Cinahl.

Because private oncology practitioners play such a central role in the care of cancer patients in this country, we feel it essential that Community Oncology be included in Medicare’s determinations of key aspects of their care.

If Medicare staff members have any questions about the journal, please have them contact our Managing Editor, Randi Londer Gould at r.gould@elsevier.com . We thank you for your consideration.

Respectfully submitted,

Lee S. Schwartzberg, MD, FACP
The West Clinic
Memphis, TN
Linda D. Bosserman, MD, FACP
Wilshire Oncology Medical Group
La Verne, CA
David H. Henry, MD, FACP
Pennsylvania Hospital
Philadelphia, PA

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) solicitation "Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used for Anticancer Treatment," which was issued on October 27, 2006. Hoffmann-La Roche Inc. (Roche) is a leader in oncology and provides a number of essential drugs used to treat conditions and diseases which are unfortunately common to those in the Medicare population, such as metastatic colorectal and breast cancer.

Under section 1861(t)(2)(ii)(II) of the Social Security Act, the Medicare program covers a new use of an anticancer chemotherapy drug if a carrier determines that the use is "medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this subclause by the Secretary." This coverage policy provides important access to innovative treatment for cancer patients. We agree with the American Society of Clinical Oncology (ASCO) that patient care has evolved since the original list was published in 1993, and we also believe that additional journals reflecting research into these changes should be added.

Roche recommends that CMS consider adding the following journals to the list of publications in Chapter 15, section 50.4.5 of the Medicare Benefit Policy Manual:

We believe that these four journals utilize sound peer-review processes, consistently provide unique insights into new uses of oncology prescription drugs, and are relied upon by clinicians. We thank CMS for seeking public comment on these important resources that aid physicians and patients.

Roche would also like to take this opportunity to raise an important and related point, which is to urge CMS to update the list of compendia organizations recognized by the Medicare program.

Section 1861(t)(2)(B) of the Social Security Act provides the Secretary of Health and Human Services with the authority to revise the list of compendia that are used to determine Medicare Part B coverage of oncology drugs for off-label uses. New use prescribing is particularly common in oncology, where patients urgently need access to a wide spectrum of medications for life-saving purposes.

As you know, requests for official recognition of additional compendia have been made by the public. CMS held an exceptional town-hall meeting on this topic last spring, and clearly has strong candidates for additional compendia. We urge the Agency to act on the compendia matter as soon as possible.

Thank you for the opportunity to comment on these matters, and we would be pleased to provide any additional information.

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I am writing on behalf of all of my colleagues in the Mayo Clinic Cancer Center who strongly support, appreciate, contribute to, and use The Oncologist and the Journal’s superb CME activities.

As you know, our Comprehensive Cancer Center, as do others, strives to put on courses intended to truly help oncology practitioners. The shared partnership of those who present at our Annual Mayo Clinic Hematology-Oncology Reviews and The Oncologist allows us to reach out and provide education to a much greater audience than only those able to attend our meetings. And I know The Oncologist is the catalyst for many other institutions charged with creating and disseminating new knowledge to reach wide audiences.

We believe that in this time when pay-for-performance and interest in quality metrics are accelerating throughout our profession, having excellent CME is a bedrock need. The Oncologist’s CME offerings are comprehensive, aimed squarely at practicing oncologists, cover areas often not covered in other oncology journals, and most importantly reach an audience vital to the practice of oncology in our communities. I think the CME program well serves our patients, their families and our profession.

The Oncologist has, over almost a dozen years, earned the respect and seniority to be listed as one of the approved medical journals for the purpose of evaluating the medically accepted indications for drugs and biologicals used for anticancer treatment.

Lawrence A Solberg, Jr., Ph.D., M.D.
Professor of Medicine
Mayo College of Medicine
Director, Clinical Cancer Research Program -
Florida
Mayo Clinic
4500 San Pablo Road
Jacksonville, Florida 32224

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This comment also submitted in a PDF file via email to caginquiries@cms.hhs.gov.

LCDR Tara Turner, Pharm.D.
Centers for Medicare & Medicaid Serivces
7500 Security Blvd, Mail stop: S3-02-01
Baltimore, MD 21244

Dear Dr. Turner:

This letter is in response to the solicitation for public comments by the Centers for Medicare & Medicaid Services (CMS) on the list of journals used by local Medicare contractors to determine medically accepted indications for drugs and biologicals used in anticancer treatment.

According to section 1861 (t)(2)(B)(ii)(II) of the Social Security Act, Medicare recognizes a “medically accepted indication” for the off-label use of a drug or biological used in an anticancer treatment regimen if the carrier involved determines that the use is “medically accepted based on supportive clinical evidence in peer-reviewed medical literature appearing in publications which have been identified for purposes of this subclause by the Secretary.” Chapter 15, section 50.4.5 of the Medicare Benefit Policy Manual identifies 15 publications as CMS-recognized journals.

Genentech supports the list of journals recommended by the American Society of Clinical Oncology (ASCO) in their letters dated May 21, 2003 and May 4, 2006.

Additionally, we request that CMS consider the additional journals listed below to supplement the list recommended by ASCO. Genentech surveys, evaluates and collects published clinical and scientific data from the peer-reviewed literature to respond to inquiries from medical professionals. Our database shows that in addition to the ASCO list of recommended journals, the peer-reviewed journals listed below publish important, relevant and timely clinical and scientific data based on primary research; these journals are not included in the CMS list or the ASCO list.

A summary that includes additional information about each of these journals, including a brief description, the publisher, and website information is attached to the PDF file of this letter submitted to caginquiries@cms.hhs.gov.

Genentech appreciates the opportunity to comment on this important issue. Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States.

Please do not hesitate to contact me at 650-467-0415 if you have any questions or require additional information. Thank you in advance for your attention in this matter.

Sincerely,

Iris Tam, Pharm.D.
Associate Director
Medical Communications Department
Genentech, Inc.

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On behalf of Consumers Union, the independent, non-profit publisher of Consumer Reports, we write in strong support of the comment by the Center for Science in the Public Interest.

In recent years, there have been repeated exposes of publication bias, distortions, conflicts of interest, and falsified data published in the most prestigious of medical journals. Before expanding the number of journals where publication can be accepted in order to qualify for coverage of the off-label use of drugs, CMS must make sure that the highest ethical standards are being met. Equally important, it is essential that only publicly registered clinical trial articles be accepted for publication. Only by registering a clinical trial can researchers determine whether the end points or length of time for the trial have been changed in ways that hide adverse data and exaggerate beneficial data. The recent example of Paxil’s use among younger patients is a classic example of how trials showing that the drug was less useful than a placebo and caused suicidality among young people can be hidden.

We appreciate your efforts to ensure the rapid coverage of drugs which can bring life-saving help to some of our nation’s most severely ill patients. To ensure that these drugs are honestly presented to patients and their doctors—and that taxpayers do not end up paying for drugs that are (per the Paxil example) less useful than sugar pills—we hope that you will insist on

The recently reported abuses of medical journals are so serious that we hope CMS will regularly review all journals it accepts for off-label coverage to ensure compliance with the above minimum criteria.

Thank you for your consideration of these views.

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In response to your October 27, 2006, posting, “Medical Literature for Local Medicare Contractors to Determine Medically Accepted Indications for Drugs and Biologicals Used for Anticancer Treatment,” we propose that The Journal of Supportive Oncology, for which we serve as editors, be added to the Medicare Benefit Policy Manual as one of the designated medical journals used to determine whether new uses of anticancer drugs should be recognized as “medically accepted indications.”

The journals recommended by the American Society of Clinical Oncology (ASCO; May 4, 2006) are excellent publications and worthy additions to the Medicare Benefit Policy Manual. However, they—and, in fact, most oncology journals—are focused on curative therapies primarily, with relatively few pages available for discussion of the essential supportive care measures for best patient management.

As healthcare providers, our understanding of the pathophysiology of treatment- and cancer-related symptoms is expanding, and with this knowledge comes the potential to improve the quality of life for patients with cancer and the quality of care we can provide. Unfortunately, the cure/care dichotomy remains, and supportive therapies are not fully integrated into oncologic care.

Despite major advances in cancer biology and therapeutics, cancer and its treatment continue to cause devastating suffering, not only for the many patients who will die of their illness but also for those who are successfully treated. Comprehensive, cure-oriented cancer care must incorporate treatment interventions that effectively manage symptoms and improve quality of life. Optimal symptom control and supportive care are best achieved when they are incorporated from the time of diagnosis and throughout the course of illness, whether or not the underlying cancer is curable.

On many levels, the everyday practice of oncology has integrated symptom management effectively. For example, who would prescribe platinum-based therapy without appropriate antiemetics? Prophylaxis for infection and cytopenias is standard for patients undergoing high-dose chemotherapy. Bisphosphonates are routinely prescribed for women with metastatic breast cancer and osteolytic bone lesions to prevent fractures and decrease skeletal metastases-related pain.

Since its inception in 2003, The Journal of Supportive Oncology has focused on symptom and side effect management, communication issues, and end-of-life care for patients with cancer. Each issue presents peer-reviewed original research articles on symptom management, review articles with accompanying peer commentary on supportive oncology topics, and “How We Do It” articles that present practical application of knowledge from both research and clinical experiences. Each submitted article receives an initial review from two members of the editorial board; those deemed suitable are then sent to two or more experts in the field for an independent peer review. Any applicable conflicts of interest are published with each article. The journal is sent to over 29,000 oncology professionals in the United States, is published 10 times per year, and is indexed in Index Medicus/MEDLINE, EMBASE, Chemical Abstracts, and CINAHL. The Journal of Supportive Oncology is the only publication that addresses new and evolving methods of supportive oncologic care for such a large audience and with such regular frequency; in this way, the journal is in a unique position to educate readers in the off-label use of drugs or biologicals as supportive care for cancer treatment.

It is encouraging that research and knowledge, particularly in the area of treatment-related symptoms, have received increased attention over recent years. Unfortunately, many patients still suffer from inadequately assessed and inadequately treated tumor-related symptoms. We as a community of professionals are in a position to change this. To this end, The Journal of Supportive Oncology will continue to address research and clinical issues that promote the full integration of symptom management into cancer care, and we recommend that it be included in the revision to the Medicare Benefit Policy Manual.

If your staff requires any further information on The Journal of Supportive Oncology, they should contact Conor Lynch at (631) 424-8900 x321. Thank you for the opportunity to comment.

Sincerely,

Jamie Von Roenn, MD
Robert H. Lurie Comprehensive Cancer Center and
Feinberg School of Medicine, NorthwesternUniversity
Michael J. Fisch, MD, MPH, FACP
The University of Texas M. D. Anderson Cancer Center
Barbara A. Murphy, MD
Vanderbilt-Ingram Cancer Center
Judith A. Paice, PhD, RN, FAAN
Robert H. Lurie Comprehensive Cancer Center and
Feinberg School of Medicine, Northwestern University

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On behalf of The Endocrine Society, representing more than 13,000 physicians and scientists in the field of endocrinology, including endocrine oncology, we appreciate the opportunity to provide comments on the designated set of medical journals that the Medicare program uses to determine whether new uses of anticancer drugs should be covered. The Endocrine Society has reviewed the existing list of journals and would like to recommend the addition of the Society’s publication Journal of Clinical Endocrinology & Metabolism (JCEM).

JCEM, as the premier publication in our subspecialty worldwide, clearly has significant scientific value and publishes original research only after a rigorous peer review process. The peer review process ensures anonymity of the reviewer, allowing for a critical and unbiased scientific and literary appraisal of reports of research in the field of the reviewer’s knowledge and skills. While the monthly journal publishes peer-reviewed papers on varying topics of clinical importance to endocrinologists, 195 original papers have been published since 2000 on the topic of cancer. These papers have focused on the diagnosis and treatment of thyroid, brain, prostate, endometrial, adrenal, colorectal, and breast cancer, among others. Furthermore, JCEM evaluates in depth certain hormone-related treatments that may not appear in standard cancer journals.

The Thomson Scientific Journal Citation Report provides an Impact Factor that measures the number of times a journal’s articles are cited over a year in comparison to the number of articles published in that same year; JCEM’s Impact Factor for 2005 was 6.020, placing the journal 8th out of 89 journals that meet Thomson’s criteria in the category of Endocrinology and Metabolism.

Among its editors, Dr. Paul Ladenson, JCEM’s Editor-in-Chief, and Dr. David Cooper, Deputy Editor-both from Johns Hopkins University-are internationally recognized authorities on thyroid cancer. A majority of the journal’s Associate Editors have scientific interests in other malignancies, including Dr. Robert Barbieri (Harvard Medical School: gynecological cancers), Dr. Shalender Bhasin (Boston University: prostate and testicular cancers), Dr. Charis Eng (Cleveland Clinic: genetic oncology, particularly the multiple endocrine neoplasia syndromes), Dr. Sally Radovick (Johns Hopkins: pediatric neuroendocrine tumors), Dr. Janet Schlechte (University of Iowa: pituitary and hypothalamic tumors), Dr. Dolores Shoback (University of California—San Francisco: bone metastases and hypercalcemia of malignancy), and Dr. William Young (Mayo Clinic: adrenal malignancies).

In conclusion, the Society appreciates the opportunity to submit these brief comments regarding the addition of the Society’s journal to the list of designated medical journals.

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