Smoking & Tobacco Use Cessation Counseling

I am a tobacco control professional with ten years experiene in the state of Massachusetts. My focus of activity has been on advocacy, public education, and policy promotion, and enforcement. As more and more states adopt proactive laws rohibiting smoking in workplaces, public places, and restrictions that may also restrict or prohibit smoking in nursing homes, the need to expand the availability and accessibility of evidenced based tobacco treatment services for persons of all ages and socioeconomic backgrounds has grown. It is also apparent that the leading preventable cause of death in this nation is tobacco related illnesses which continue to escalate our health care and loss of productivity and lives prematurely. This proposal does offer the potential for helping to address medicare eligle individuals with tobacco treatment services. However, I have some concerns as to who may be considered qualified to provide treatment interventions under the proposed plan.

Currently, U Mass Medical School offers an outstanding tobacco treatment specialist certification program. Will persons who are currently certified but not necessarily listed in the list of proposed providers be disqualified from providing these important services?

In Massachusetts, we have benefitted from having access to the quitline. I frequently refer smokers looking who want to quit to the quitline for information, support and counseling. The DPH has demonstrated innovation during our current state fiscal crisis by developing Quitworks in collaboration with major health insurers and health care providers to create a link between health care providers and the quitline that will assist and support quitters in their attempts between physician visits by highly skilled and trained counselors. The current proposal fails to provide support for quitline resources which have become more essential in helping smokers of all ages through the process of quitting. Finally, I am concerned over the lack of funding support for the over the counter NRT. In closing, the proposal is a big step in the right direction. We need to expand and insure the availability of treatment resources for smokers of all ages and means.

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As Director of the Arizona Department of Health Services, I strongly support the decision by CMS to provide tobacco dependence treatment to Medicare recipients. Not only does tobacco use cause nearly half a million deaths per year, millions live with and suffer from chronic illnesses that are caused by smoking. As cited by the Campaign for Tobacco Free Kids, in Arizona alone, nearly 7,000 Arizona adults will die because of smoking. Moreover, 131,000 kids now under 18 and alive will ultimately endure the disease, disability, and premature death as a result of tobacco use and dependence.

The evidence is clear that tobacco dependence treatment is effective when implemented as recommended by the Public Health Service (PHS) Clinical Practice Guideline: Treating Tobacco Use and Dependence. Providing effective treatment services to tobacco users who present with early signs and symptoms of the ill effects of tobacco use will result in reduced morbidity, reduced mortality, and reduced health care costs. Although treatment is essential for those who present with tobacco-related illnesses, prevention is also crucial.

As recommended in the PHS Guideline: Treating Tobacco Use and Dependence and the CDC Best Practices for Comprehensive Tobacco Control Programs publications, and as applied in Arizona, tobacco cessation services should be comprehensive. Not only should mass media efforts promote the urgency to quit and pharmacotherapy be offered, treatment services provided by trained health care providers (to include lay health workers) are essential. Regardless of where services are offered whether it be through a clinic, hospital, or telephonic counseling a trained provider using a scientifically supported intervention significantly improves the tobacco users likelihood of a successful quit.  Not only would Medicare recipients benefit from effective treatment services, all tobacco users benefit when providers are appropriately trained and reimbursement is offered.

The unfortunate reality is that there is a tremendous need for programs to train and certify tobacco cessation providers. This need has been recognized for a number of years as noted in testimony offered by Dr. Michael Barry of the American College of Preventive Medicine to the DHHS Cessation Subcommittee Interagency Committee on Smoking and Health in October of 2002. In his testimony, Dr. Barry referenced the Massachusetts certification program and the Arizona certification program as models for further investigation.

Specific to Arizona, evidence-based provider continuing education, certification, and training efforts at a Basic and Intensive level have been ongoing since 1998. The Arizona certification model recognizes the need to apply best practices and seeks to increase skill-based competencies and foster self-efficacy through Basic and Intensive multimodal educational interventions. To date certified providers in Arizona show statistically significant improvement in knowledge, self-efficacy and quality improvement measures. There is convincing data that evidence-based tobacco use cessation interventions are put into practice and support systems are developed  as recommended by the PHS Guideline: Treating Tobacco Use and Dependence through successful completion of the Arizona certification program.

As a state with long-standing commitment to and investment in comprehensive tobacco control programming and well-respected approach to cessation, it is with great pleasure that I offer Arizona's support as CMS implements this new policy.  

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As Commissioner of Health for the State of New York and former Surgeon General of the United States, I strongly support the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing to provide coverage for tobacco cessation counseling services under Medicare. This decision by CMS is well-supported by the evidence base. Providing this coverage will have a significant, positive impact on the health of millions of seniors for many years to come.

Beginning in January 2006, prescription pharmacotherapies for tobacco cessation will become available to all Medicare beneficiaries, as well. This is another important and positive change. However, it will be extremely important that CMS ensure access to over-the-counter pharmacotherapies, available through a physician’s “order.” Here in New York, we provide over-the-counter cessation medication to Medicaid enrollees, with a physician order. This is a cost saving measure that also provides more choice to tobacco users who want to quit.

The lack of mention of cessation quitlines in the CMS proposal was puzzling, given the solid evidence base around this intervention modality, the CMS's funding of a large national trial that specifically included a quitline arm, and the Department of Health and Human Services initiative to develop a national network of quitlines linked with a national toll-free number (1-800-QUIT NOW). To further reduce the cost of this proposed new benefit and to extend ease of access for our seniors, CMS should consider reimbursing state cessation quitlines that provide quality behavioral counseling to seniors and others seeking to quit smoking. Here in New York, we support a Fax-to-Quit program whereby health care providers refer patients to the state Smokers’ Quitline by fax. Trained Quitline counselors then contact patients, provide cessation counseling and services, and send reports back to referring providers. Linking the new Medicare counseling coverage to the national network of quitlines would constitute an important step in increasing seniors’ access to cessation services. Guidance from CMS on the qualifications for cessation specialists would be particularly helpful, both for quitlines and for health care organizations.

Finally, I urge CMS and the Department of Health and Human Services to fully implement all the recommendations of the cessation National Action Plan: Preventing 3 Million Premature Deaths, Helping 5 Million Smokers Quit: A National Action Plan for Tobacco Cessation developed by the Subcommittee on Cessation of the Interagency Committee on Smoking and Health and submitted to Secretary Thompson in February 2004. The current decision by CMS is only one element of this overall strategy to combat the devastating toll of tobacco use on the American public. The entire action plan, if implemented, would have an historic impact on tobacco use rates in the United States, would help more than five million smokers quit, and would save over three million lives. Some of the action plan can readily be addressed administratively, much like the action taken by CMS on counseling for Medicare, while other provisions will require legislative authority and budgetary resources to execute. Again, we strongly support this action by CMS and hope you will consider New York’s comments to increase even further access to cessation counseling and products.

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RE: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N)

Dear Dr. Phurrough:

On behalf of the Leade Health Inc., a disease prevention company providing telephonic tobacco cessation programs, I would like to thank CMS for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling.

Leade ’s experience working with the elderly population suggests that older populations respond very well to telephonic coaching for tobacco cessation.

LHI performed a comparison of outcomes for a health plan client among all telephonic cessation program participants to participants in the 55-64 age group and participants in the 65 plus age group. Compared to Leade Health’s norms, the older age groups reported higher tobacco use, were more likely to rate health as poor, had a greater incidence of chronic disease, and were less confident that they could quit.

Interestingly, the older age groups had better quit rates after 12 months compared to Leade Health norms, and fewer dropped out of the program compared to younger participants. Among the 55-64 age group, 30% were tobacco free at 12 months (using the intent to treat analysis), and the quit rate at 12 months was even higher for the 65 plus age group (36%) compared to Leade Health’s 12 month quit rate norm of 27%. In addition the older populations were more compliant with the proactive calls.

Leade Health is currently partnering with the Michigan Department of Community Health to provide Quit Line services for Michigan residents. We also provide telephonic programming for older populations via our health plan partnerships. We support your proposal to provide coverage for tobacco cessation under Medicare.

Thank you for providing Leade Health with the opportunity to provide comments regarding the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling.

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On behalf of the American College of Preventive Medicine (ACPM), I am submitting comments on the Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N) issued by the Centers for Medicare and Medicaid Services (CMS). ACPM is the national professional medical society for physicians whose expertise and interest lie in disease prevention and health promotion. ACPM’s more than 2,000 members are engaged in preventive medicine practice, research, and teaching. ACPM advocates for the specialty of preventive medicine and for national policies that promote health and prevent disease.

ACPM strongly supports the December 23, 2004 announcement by CMS proposing coverage for tobacco cessation counseling services under Medicare. The decision by CMS is well-grounded in the evidence base, and providing this coverage will have a significant, positive impact on the health of millions of seniors for many years to come.

ACPM’s specific comments are grouped into three categories below: treatment covered; smokers covered; and providers who can deliver the counseling. In short, ACPM urges CMS to adopt a final rule that would provide full coverage for tobacco cessation counseling for the two groups identified in its original proposal (smokers who have a smoking-related condition or who are taking a medication affected by smoking) PLUS coverage of cessation counseling as a mental health service for other smokers who meet specific coding criteria, as defined below.

TREATMENT COVERED

It is critical that Medicare beneficiaries have access to the full spectrum of tobacco cessation services, including behavioral interventions and pharmacotherapies. While the College recognizes that the original petition did not address pharmacotherapy for tobacco cessation, we urge CMS to ensure that the implementation of the counseling benefit is done in such a manner as to maximize the availability and impact of both counseling and pharmacotherapy services. ACPM is aware that, beginning in January 2006, prescription pharmacotherapies for tobacco cessation will become available to all Medicare beneficiaries under the Medicare Modernization Act (MMA) of 2003, and we applaud that upcoming change. When implementing the MMA prescription drug provisions related to FDA-approved cessation drugs, we urge CMS to ensure access to over-the-counter pharmacotherapies that are available via a physician’s prescription (e.g., “legend” transdermal nicotine patches).

Also, ACPM in general supports the scope of cessation services proposed in the decision memo. However, we urge CMS to find a mechanism to ensure coverage of smoking cessation services for seniors who might require overnight stay in a hospital or some other residential facility during the course of treatment (e.g., when a patient becomes suicidal while attempting to quit smoking).

Finally, ACPM supports access to comprehensive, evidence-based tobacco cessation services within all federally-funded health care programs (e.g., Medicare, Medicaid, FEHBP, federally qualified health centers, rural health centers, etc…). Consistent with ensuring that evidence-based treatment services are available through all federally-funded programs, we urge CMS and HHS to fully implement all the recommendations of the cessation National Action Plan (Preventing 3 Million Premature Deaths, Helping 5 Million Smokers Quit: A National Action Plan for Tobacco Cessation) developed by the Subcommittee on Cessation of the Interagency Committee on Smoking and Health and submitted to Secretary Thompson in February 2004. The current decision by CMS is a small part of this overall strategy to combat the devastating toll of tobacco use on the American public. The entire action plan, if implemented, would have an historic impact on tobacco use rates in the United States and would help more than five million smokers quit and save over three million lives. Some of the action plan can readily be addressed administratively (much like the action taken by CMS on counseling for Medicare) while other provisions will require legislative authority and budgetary resources to execute (e.g., adequate and sustained funding for the national telephone quitline network).

SMOKERS COVERED

ACPM endorses CMS’ proposal for Medicare coverage of tobacco cessation counseling for smokers who have a smoking-related condition or who are taking a medication affected by smoking. However, ACPM believes that it is critical for all Medicare beneficiaries who smoke—including smokers who have not yet developed overt symptoms or illness related to smoking— to have access to effective, comprehensive smoking cessation services. The sooner these beneficiaries have access to these services, the more likely they are to quit smoking and to avoid the multitude of diseases and illnesses attributable to tobacco use.

We recognize, however, that CMS is restricted in its authority to administratively cover services that are purely preventive in nature. As such, we urge that CMS add coverage of cessation counseling as a mental health service for smokers who meet ANY of the following definitions:

January 20, 2005

Steve Phurrough, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-28
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N)

Dear Dr. Phurrough:

On behalf of the Tobacco Control Resource Council, thank you for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling. As the organization representing State Tobacco Control Program Managers, we strongly support the coverage of tobacco cessation counseling services under Medicare.

People who quit smoking, regardless of their age, live longer, healthier lives than those who continue to smoke. Counseling - by physicians or by trained counselors over the telephone or in individual or group support settings - is among the most effective means of helping smokers quit. Unfortunately, limiting counseling coverage to those who already have a tobacco related illness prevents many smokers who want to quit from accessing interventions that could prevent them from ever becoming ill. As such, we strongly encourage CMS to expand the coverage to all tobacco users and not limit counseling reimbursement to those with tobacco- related disease.

We also want to request that CMS consider including quitlines in a benefit category. Quitlines are evidence-based and effective (Fiore MC, et al, Treating Tobacco Use and Dependence: Clinical Practice Guideline, 2000) in terms of bringing about abstinence from tobacco use and improving health outcomes. The memorandum did not address the use and effectiveness of quitlines for cessation counseling and we believe that the evidence is adequate to conclude that quitlines are “reasonable and necessary.” We also understand that additional modifications would be needed to include quitlines since they are often supported by “government” funds and this factor currently precludes reimbursement under Medicare. This additional barrier would need to be addressed and we urge your exploration of possible solutions.

Thank you again for the opportunity to provide comments on this important issue. Should you have any questions about these comments, please contact Karen DeLeeuw, Chair, Tobacco Control Resource Council at 303-692-2515 or karen.deleeuw@state.co.us.

Sincerely,

Karen DeLeeuw, MSW

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AMERICAN ASSOCIATION FOR RESPIRATORY CARE
9425 North MacArthur Blvd., Suite 100
Irving, Texas  75063

January 21, 2005

Marcel Salive, MD, MPH
Director, Division of Medical & Surgical Services
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD  21244

RE: Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling (CAG-0024IN)

Dear Dr. Salive:

The American Association for Respiratory Care (AARC) submits the following comments on the draft decision memo proposing coverage for tobacco cessation counseling under Medicare.  The AARC is a national professional association representing over 37,000 respiratory therapists.

The AARC appreciates the opportunity to comment on the draft memo and we commend the Centers for Medicare and Medicaid Services (CMS) for offering this coverage to Medicare patients.  While we understand that the implementation of the Medicare prescription drug benefit beginning in January 2006 will cover prescription pharmacotherapies for tobacco cessation, we applaud the agency’s coverage of counseling services at this time which are critical to helping patients sustain their tobacco cessation efforts.

The AARC urges the CMS to recognize the role that respiratory therapists provide in smoking and tobacco cessation services and we recommend that CMS specifically cite respiratory therapists as a qualified provider of these services under the proposed policy.

Respiratory therapists are on the front line in providing care to Medicare patients with asthma, emphysema, chronic bronchitis, lung cancer, and other respiratory diseases.  As a highly specialized allied health discipline, respiratory therapists focus on the management and treatment of patients with acute and complex respiratory problems in a broad spectrum of settings.  They assess and develop patient care plans as part of their scope of practice.  Respiratory therapists are in a unique position to dispense tobacco cessation counseling as they are called on daily to evaluate and administer physician-ordered treatments for tobacco-related respiratory diseases.

Marcel Salive, MD, MPH
Director, Division of Medical & Surgical Services
Coverage and Analysis Group
7500 Security Boulevard - C1-09-28
Baltimore, Maryland 21244

RE: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use CessationCounseling (CAG 00241N)

Dear Dr. Salive:

This letter is being submitted on behalf of a number of organizations committed to reducing death, disease and disability caused by tobacco use. We strongly support the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare. The decision by CMS is well-grounded in the evidence base and providing this coverage will have a significant, positive impact on the health of millions of seniors for many years to come.

The decision by CMS to provide coverage of counseling services sets a clear and strong precedent that should be followed by further actions to ensure that all federally-covered lives have access to the full spectrum of tobacco cessation services, including behavioral interventions and pharmacotherapies. While the current decision by CMS only addresses counseling services, we recognize that, beginning in January 2006, prescription pharmacotherapies for tobacco cessation will become available to all Medicare beneficiaries, and applaud that upcoming change as well. We urge CMS to ensure that the implementation of the counseling benefit is done in such a manner as to maximize the availability and impact of both counseling and pharmacotherapy services. For example, when implementing the prescription drug provisions related to FDA-approved cessation drugs, we urge CMS to ensure access to over-the-counter pharmacotherapies that are available via a physician’s prescription (e.g., “legend” transdermal nicotine patches).

While we applaud this decision, we also want to reiterate our support for access to comprehensive, evidence-based tobacco cessation services within all federally-funded health care programs (e.g., Medicare, Medicaid, FEHBP, federally qualified health centers, rural health centers, etc…). Consistent with ensuring that evidence-based treatment services are available through all federally-funded programs, we urge CMS and the Department to fully implement all the recommendations of the cessation National Action Plan (Preventing 3 Million Premature Deaths, Helping 5 Million Smokers Quit: A National Action Plan for Tobacco Cessation) developed by the Subcommittee on Cessation of the Interagency Committee on Smoking and Health and submitted to Secretary Thompson in February 2004. The current decision by CMS is a small part of this overall strategy to combat the devastating toll of tobacco use on the American public. The entire action plan, if implemented, would have an historic impact on tobacco use rates in the United States and would help more than five million smokers quit and save over three million lives. Some of the action plan can readily be addressed administratively (much like the action taken by CMS on counseling for Medicare) while other provisions will require legislative authority and budgetary resources to execute (e.g., adequate and sustained funding for the national telephone quitline). Our organizations stand ready to support you in further efforts to implement the National Action Plan.

Once again, we want to reiterate our strong support for the proposal announced by CMS on December 23, 2004 for coverage of tobacco cessation counseling under Medicare.

Sincerely,

Action on Smoking or Health
American Academy of Family Physicians
American Academy of Nurse Practitioners
American Academy of Pediatrics
American Association for Respiratory Care
American Cancer Society
American College of Cardiology
American College of Chest Physicians
American College of Occupational and
Environmental Medicine
American College of Physicians
American College of Preventive Medicine
American Dental Association
American Dental Hygienists' Association
American Heart Association
American Lung Association
American Psychological Association
American Public Health Association
American Society of Addiction Medicine
American Thoracic Society
Association of Maternal and Child Health Programs
Association of Schools of Public Health
Association of Teachers of Preventive Medicine
Association of Women's Health, Obstetric and
Neonatal Nurses
Campaign for Tobacco-Free Kids
Center for Tobacco Cessation
Community Anti-Drug Coalitions of America/Drug-
Free Kids Campaign
C-Change, formerly the National Dialogue on Cancer
March of Dimes
National Association of County and City Health
Officials
National Latino Council on Alcohol and Tobacco
Prevention
National Research Center for Women & Families
National Women's Law Center
Oncology Nursing Society
Society for Public Health Education
Society for Research on Nicotine and Tobacco
University of Wisconsin Center for Tobacco
Research and Intervention

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We are aware that The Centers for Medicare and Medicaid Services (CMS) have proposed new Medicare coverage to establish smoking and tobacco cessation counseling. Following please find enclosed a copy of our comments on the proposed decision. We believe our comments will improve the decision summary.

Comments for The Centers for Medicare and Medicaid Services

Regarding the December 23, 2004 Draft Decision Memo for Smoking & Tobacco Cessation Counseling (CAG-00241N)

The following comments are provided regarding the proposed decision summary published in the Medicare Coverage Database on December 23, 2004 to establish smoking and tobacco cessation counseling as a covered benefit for Medicare beneficiaries.

1. The decision memo states the smoking and tobacco cessation counseling may only be provided by individuals trained in tobacco use cessation counseling. On pages 3 and 4 of the Decision Summary the benefit categories for smoking cessation counseling are further stated to be:

I would like to offer some comments for those who work in and for the efforts of the Comprehensive Tobacco Control Program for the State of Vermont. We would like to recognize this step by CMS as a very important advancement in the field of tobacco control. The Vermont Comprehensive Tobacco Control Program would like to see in the near future this initiative expanded in the following ways:

- We encourage the coverage of smoking cessation treatment be available to all those who are enrolled in Medicare and smoke, and not have coverage limited to those who have a co-morbid condition.

- Additionally, we would see those in Medicare have access to coverage for the front line pharmacotherapies that are mentioned in the proposal. Combining these pharmacotherapies with behavioral counseling significantly increases a person’s likelihood of having a successful quit attempt.

The Tobacco Control Program and its stakeholders would also like to see a standard education requirement for providers to be eligible to qualify for reimbursement. We also feel it important that some standard for re-certification through continuing education be set as well. In the state of Vermont we endorse the Standards of Practice as set up by the Association for the Treatment of Tobacco Use and Dependence. (ATTUD).

The stakeholders in the state of Vermont would also like to see reimbursement to be opened up to more professions other than physicians. In our state we currently have highly trained professionals in the fields of nursing, respiratory therapy, substance abuse, social work, diabetes educations and general health education who are embedded in our health care system currently providing these services.

We believe that this is a very important step in the field of treating tobacco dependence. We feel that this proposal will have positive impacts on thousands of Vermonters and millions of Americans.

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January 21, 2005

Mark A. McClellan, M.D., Ph.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Room 314-G – HHH Building
Washington, D.C. 20201

RE:Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling (CAG-00241N)

Dear Dr. McClellan:

We recommend that cessation counseling be covered for all Medicare beneficiaries, rather than only for beneficiaries who have been diagnosed with a tobacco-related illness or who are taking medications whose metabolism or dosing is affected by tobacco use, as proposed by CMS. We believe this change will ensure access to cessation counseling for all beneficiaries who might be undertaking smoking “quit attempts.” The data support this expansion, as the data reviewed by the agency establish the effectiveness of counseling services when utilized by senior citizens, including but not limited to those who have co-morbidities associated with smoking. The agency has concluded that cessation counseling is a cost-effective intervention, and an expansion of the proposed benefit to include smokers who may not have a smoking-related diagnosis should pose no financial burden for the program.

There is some evidence that older smokers, because of the length of time they have smoked and the strength of their addiction, may require more quit attempts and more intensive services during their quit attempts. Therefore, the proposed coverage of two quit attempts, with four counseling services (intermediate or intensive services) during each quit attempt, may not be adequate for older smokers. In its decision, the agency has cited evidence that supports a dose-response relationship between the length of time spent on each counseling session, number of sessions, and total length of counseling (the dose) and the effectiveness of counseling (the response), and the dose-response relationship should be carefully monitored for the older smokers who will be the primary target for this benefit.

We are gratified that CMS intends to provide well- defined and unique codes for the counseling services and to use the codes to evaluate per- capita utilization of services, as well as outcomes and patient experiences. This ongoing evaluation should allow the agency to determine whether the coverage standard is appropriate for older smokers in terms of the number and length of covered sessions. The proposal would allow payment only for services provided by individuals trained in tobacco use cessation counseling. We recommend that training according to the 2000 Clinical Guideline ofthe United States Public Health Service be the standard for providers. Adherence to this clinical guideline would ensure that beneficiaries are receiving appropriat services but would not unreasonably restrict access to services.

We commend CMS for its decision to cover tobacco cessation counseling, and we look forward to working with the agency to educate beneficiaries and health care professionals regarding the availability of this new service.

Sincerely,

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I am writing on behalf of the American Academy of Family Physicians, which represents more than 94,000 physician and medical students nationwide. Specifically, I am writing to offer our comments on the Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling (CAG-00241N) that CMS released on December 23, 2004.

In the draft decision memo, CMS proposes that the evidence is adequate to conclude that smoking and tobacco use cessation counseling, based on the current U.S. Public Health Service (PHS) Guideline, is reasonable and necessary for a patient with a disease or an adverse health effect that has been found by the U.S. Surgeon General to be linked to tobacco use, or who is taking a therapeutic agent whose metabolism or dosing is affected by tobacco use as based on FDA-approved information. The counseling may only be provided by individuals trained in tobacco use cessation counseling.

CMS notes that minimal counseling is already covered at each evaluation and management visit. Beyond that, Medicare proposes to cover two cessation attempts per year. Each attempt may include a maximum of four intermediate or intensive sessions, with the total annual benefit covering up to eight sessions in a 12 month period. The physician or other health care professional and the patient have flexibility to choose between intermediate or intensive cessation strategies for each attempt.

The American Academy of Family Physicians enthusiastically supports the proposed coverage policy. It is a step in the right direction and consistent with AAFP policy that supports health plan coverage and appropriate reimbursement for evidence-based physician services for treatment of tobacco use, including nicotine replacement therapy and behavioral modification. Nicotine replacement therapy (both prescribed and over-the-counter) is an effective component of tobacco cessation treatment and generally increases rates of smoking cessation especially when combined with behavioral modification. These FDA-approved therapies are described in the USPHS Clinical Practice Guideline entitled, Treating Tobacco Use and Dependence, Revised June 2000, U.S. Public Health Service. Further, the American Academy of Family Physicians urges members to work cooperatively with other health professionals to provide cessation counseling and other treatments, consistent with the proposed policy.

As CMS moves to implement this policy, we believe it will need to address several questions:

What is a “session?” The coverage policy indicates that Medicare will cover a maximum of four intermediate or intensive sessions per attempt, with the total annual benefit covering up to eight sessions in a 12 month period. CMS’s use of the word “session” implies a face-to-face encounter with the health care professional providing the smoking cessation counseling. However, office-based cessation efforts often involve physician or nurse phone calls interspersed with office visits. If these phone calls count as “sessions,” then the limit of four “sessions” per attempt may not be enough. If these phone calls do not count as “sessions,” then we are curious how CMS will treat such phone calls. Also, what constitutes an “intermediate” versus an “intensive” session?

What kind of training counts? CMS states that the counseling may only be provided by individuals trained in tobacco use cessation counseling. However, CMS does not specify the amount and level of training required. Family physicians receive such training as part of their residency training, and we believe that family physicians are qualified to provide smoking cessation counseling based on that training.

How will physicians code for these services, and how much will Medicare pay for this counseling? Will physicians use traditional office visit codes (e.g., 99212-99215) for these sessions? Will they code based on the time spent counseling? It is important that Medicare addresses related billing and coding issues for several reasons. The first is that this is work that should and must occur in physicians’ offices. Secondly, it does take time and should be compensated.

How much documentation will be required? Coding and billing will demand documentation, as with other services covered and paid by Medicare. However, this should not be another Medicare paperwork burden for physicians. Unrealistic time and/or documentation requirements as part of the coverage for counseling on smoking cessation may doom effective provision of the benefit.

In asking these questions, we are not qualifying our support for the basic Medicare decision to cover smoking cessation counseling. Rather, we are simply indicating that Medicare’s decision in this instance raises additional decision points that we anticipate CMS will address through payment policy and other means. If we may be of any assistance in this regard, please let us know.

Thank you for the opportunity to comment on this proposed coverage policy. If you or your staff has any questions about this matter, please let us know.

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January 21, 2005

Mark A. McClellan, M.D., Ph.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Room 314-G – HHH Building
Washington, D.C. 20201

Re: Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling (CAG-00241N)

Dear Dr. McClellan:

The American Society of Clinical Oncology (ASCO), representing cancer researchers and clinicians, is writing to express its strong support for the Draft Decision Memo proposing Medicare coverage for tobacco use cessation counseling. The Centers for Medicare and Medicaid Services (CMS) proposal will allow physicians and other health professionals to provide important services to smokers to assist them in their smoking cessation efforts. ASCO recommends some modifications in the proposal that have the potential to enhance its impact for Medicare beneficiaries.

The CMS proposal is consistent with the recommendations in ASCO’s Policy Statement, “Tobacco Control – Reducing Cancer Incidence and Saving Lives,” released in 2003. The ASCO statement outlines a comprehensive tobacco control policy, including the need for more effective tobacco cessation services. We are gratified that CMS is acting to improve Medicare beneficiaries’ access to such services.

Provide All Smokers Access to Cessation Counseling Services

CMS has proposed that cessation counseling be covered only for Medicare beneficiaries with a disease or an adverse health effect linked to tobacco use, or those taking a therapeutic agent whose metabolism or dosing is affected by tobacco use. ASCO recommends that all smokers have access to the cessation counseling services outlined in the decision memo. Tobacco use disorder is a recognized diagnosis with ICD-9 code 305.1, and CMS should consider cessation counseling an appropriate treatment for those whose disorder is described by this diagnostic code.

CMS has evaluated the significant literature on the benefits of cessation counseling, and it has noted that a number of studies support the conclusion that such services have a positive impact on the tobacco use quit rate of those of Medicare age. Although a smaller subset of studies of older smokers with co-morbidities also supports the value of cessation counseling, the evidence supports smoking cessation in those with and without co-morbidities. We believe the more prudent course is to allow all smokers to benefit from cessation counseling.

CMS has concluded that the cessation counseling benefit will be a cost-effective one, as the total savings to Medicare, state government healthcare programs, third party payers, and consumers will exceed the costs of the benefit over a ten-year period. We do not believe the cost-effectiveness of the benefit will be compromised by extending it to all smokers, and in fact it may be enhanced.

Impose No Limits on Utilization of Intensive Counseling Services

CMS has followed the recommendations of the United States Public Health Service in recommending coverage for either intermediate (3-10 minutes) or intensive (>10 minutes) counseling sessions. The agency has also acknowledged that there is evidence to support a dose-response relationship between the length of counseling session, number of sessions, and total duration of tobacco cessation counseling (the dose) and the effectiveness of the counseling (the response). The dose-response relationship may be particularly relevant to the population being served by this benefit.

The characteristics of older smokers – longer history of smoking and longer duration of addiction – suggest that this group may face a more difficult time succeeding at smoking cessation. As a result, this population may require more intensive services. ASCO recommends that CMS refrain from establishing an arbitrary target for the portion of services that should fall in each category, intensive or intermediate counseling, or developing any limits on reimbursement if the volume of intensive services utilized exceeds the volume of intermediate services utilized.

CMS has stated that it will establish well-defined and unique codes to allow the evaluation of the per-capita rate of services provided and the measurement of outcomes and patient experiences. ASCO recommends that CMS evaluate the data to determine the dose-response relationship among the Medicare population utilizing these services.

Conclusion

ASCO commends CMS for acting promptly and positively on the request to provide coverage of smoking cessation services. With modest changes in the decision memo, these services can be provided to all Medicare beneficiaries, with potentially greater benefits not only for patients but also for the Medicare program. This coverage decision is an important step forward in this nation’s tobacco control effort.

Sincerely, David H. Johnson, M.D.
President
American Society of Clinical Oncology
1900 Duke Street, Suite 200
Alexandria, VA 22314

cc: Stephen Phurrough, MD, MPH
Director, Coverage and Analysis Group

Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services

William Larson, Policy Analyst

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January 21, 2005

The American Pharmacists Association (APhA), the national professional society of pharmacists, supports CMS’ proposal to provide coverage of smoking cessation counseling for Medicare beneficiaries. Smoking is a serious public health threat associated with coronary heart disease, vascular disease, stroke, chronic obstructive pulmonary disease, and several different types of cancer. Smoking also has a tremendous economic impact. In 1993, the estimated direct cost of health care for smoking-related illness was $50 billion for American smokers. Lost productivity and earnings due to smoking for that year was approximately $47 billion.¹

As the Agency states in its coverage decision memorandum, over 50% of smokers age 65 and older report a desire to quit smoking. However, the physically addictive properties of tobacco make it very difficult for many to quit because of discomfort due to nicotine withdrawal. Smoking cessation counseling and intervention can help increase smokers chance of success. APhA recommends that the Agency provide Medicare coverage of smoking cessation counseling.

APhA also recommends that the new coverage decision include pharmacists as a provider of smoking cessation counseling. Pharmacists are trained health care professionals who are qualified to provide this service. Pharmacists can screen their patients for tobacco use, advise smokers to quit, provide motivation to quit, and assist patients in quitting. Because pharmacists are medication experts, they can also provide information and advice on over-the-counter smoking cessation products available at the pharmacy, as well as prescription drug products that help combat nicotine withdrawal. We urge the Agency to recognize pharmacists’ ability to provide smoking cessation counseling and include pharmacists as providers of this service.

Thank you for your consideration of the views of the nation’s pharmacists. Please contact Susan K. Bishop, Associate Director, Regulatory Affairs, at 202-429-7538 or SBishop@APhAnet.org, with any questions.

Sincerely,

John A. Gans, PharmD
Executive Vice President

1. APhA Special Report: A Review of the New Smoking Cessation Strategies from the Agency for Health Care Policy and Research. 1996.

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Marcel Salive, MD, MPH
Director, Division of Medical & Surgical Services
Coverage and Analysis Group
7500 Security Boulevard - C1-09-28
Baltimore, MD 21244

RE: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N)

Dear Dr. Salive:

On behalf of the Massachusetts General Hospital and the other member hospitals of Partners Healthcare System, I am pleased to comment on the Proposed Coverage Decision Memorandum for Smoking and Tobacco use Cessation Counseling. As the research done by CMS confirms, tobacco usage continues to be the leading cause of preventable death in the US. As such, we strongly support the proposed coverage decision to provide counseling service to Medicare beneficiaries. However, we are concerned that the proposed coverage decision does not cover smoking cessation counseling for Medicare beneficiaries who are hospitalized. As Dr. Nancy Rigotti, an experienced investigator in the field of smoking cessation, Director of the Tobacco Research and Treatment Center at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, states in her comment letter to CMS "hospitalization provides a unique teachable moment when smokers are especially receptive to cessation interventions." Furthermore, as Dr. Rigotti also states in her comments, "it is not practical or cost effective to have smoking counseling in hospital settings delivered by physicians." Rather, counseling provided by specifically trained counselors, often with nursing or social work backgrounds, has been demonstrated to be efficacious and cost-effective. We therefore urge CMS to:

On behalf of the Massachusetts General Physicians Organization, the largest group of physicians in New England, I wholely endorse the submission by one of our local experts on the issue, Dr. Nancy Rigotti:

January 21, 2005

Marcel Salive, MD, MPH
Director, Division of Medical & Surgical Services
Coverage and Analysis Group
7500 Security Boulevard - C1-09-28
Baltimore, Maryland 21244

RE: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N)

Dear Dr. Salive:

Thank you for the opportunity to comment on the December 23, 2004, memorandum from the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare. My comments reflect 25 years of experience as an researcher in smoking cessation and tobacco control, as a practicing internist who has cared for many Medicare recipients with tobacco-related disease, and as Past President of the Society for Research in Nicotine and Tobacco (SRNT), the leading international society of investigators in this field.

First, I want to express strong support for the CMS proposal. This new policy will provide enormous benefit to Medicare beneficiaries in reducing and preventing tobacco-related disease.

My specific concern is that the draft memorandum does not appear to provide a mechanism to cover smoking cessation counseling for Medicare beneficiaries who are hospitalized for acute illness. This is a major gap, because hospitalization provides a unique teachable moment when smokers are especially receptive to cessation interventions. Smoking cessation counseling that starts at the bedside during hospitalization and continues after discharge (usually by proactive telephone contacts) has been shown to increase smoking cessation rates in randomized controlled clinical trials.^1-7 The efficacy of counseling is enhanced by providing nicotine replacement therapy during hospitalization and continuing it after discharge.⁸ A meta-analysis from the Cochrane Database of Systematic Reviews concludes that intensive smoking cessation counseling that begins during hospitalization and continues for more than 1 month after discharge increases smoking cessation rates by 82% compared to a control condition.^9-10 The effect is strongest in smokers who are admitted for acute myocardial infarction (MI), but the data demonstrate efficacy of this approach even when generalized to all hospitalized smokers.

Furthermore, cost-effectiveness studies have demonstrated that delivering these services are highly cost-effective. A cost-effectiveness analysis of patients admitted with acute MI found that counseling inpatient smokers was highly cost- effective, more cost-effective than providing beta-blockers after MI.¹¹ The reason is that (1) smoking cessation reduces post-MI morbidity and mortality by 30-50%, (2) counseling is relatively inexpensive and is required for only a short time (unlike a medication), and (3) post-MI patients are at high risk for incurring future high medical costs due to the nature of coronary heart disease. A similar cost-effectiveness study was done for all hospitalized patients, regardless of diagnosis, and also reported that providing the service was very cost-effective.¹²

This evidence base has led to broad support for incorporating smoking cessation counseling for hospital inpatients. It is included as a recommendation in the 2000 U.S. Public Health Service Guidelines for Treatment of Tobacco Use and Dependence. It has been adopted by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) as a measure for assessing the quality of care provided to patients hospitalized with acute MI, congestive heart failure, and community-acquired pneumonia. CMS has also adopted a very similar performance measure.

The JCAHO quality measure has been in use since 2002. In general, hospitals are falling short on it compared to their compliance with other measures such as the use of aspirin or beta- blockers after MI. A major reason has been the challenge of paying for the bedside counseling and the follow-up telephone counseling. I know from personal experience in my institution and from conversations and consultations from colleagues nationwide that this is a major barrier to improving the quality of care provided to hospital patients. Given this strong evidence base and the regulatory imperative from CMS, it is essential that Medicare’s decision about covering smoking cessation counseling extend to cover hospitalized patients who would be included if they were outpatients. In other words, I urge CMS to develop an appropriate mechanism to cover this care.

I propose that Medicare cover smoking cessation counseling services for an eligible recipient whether the beneficiary receives services as an outpatient or is hospitalized for a medical reason. This inpatient coverage would be different from the “resident” program described in the Proposed Coverage Decision. My proposal is one-time inpatient counseling while the beneficiary is hospitalized. As mentioned earlier, this intervention is especially important because of the patient’s receptivity to counseling.

As I understand it, the proposed coverage is now intended to be a Part B service. The problem is that hospital care by hospital employees is billed through Part A using DRGs rather than based on services provided. It may be that physicians could provide smoking counseling to inpatients as a Part B service, but that is not clear in the memorandum. However, it is not practical or cost-effective to have smoking counseling in hospital settings delivered by physicians. In the studies that demonstrated the efficacy and cost-effectiveness of hospital- initiated smoking counseling, the counselors were trained nurses and other counselors, usually with a background in social work, counseling, or health education. What unified them was a formal training program in smoking cessation counseling. I urge CMS to identify a mechanism by which smoking counseling in an inpatient setting could be designated as a medically necessary covered service that would be covered when delivered by a range of trained counselors in addition to physicians.

I also propose that the coverage for smoking cessation counseling services be extended to cover counseling that is provided by telephone. Effective hospital-initiated smoking interventions uniformly included a structured proactive telephone counseling program after discharge. Requiring recently hospitalized elders, many of whom are homebound, to return to a health care facility in order to receive smoking counseling face-to-face is unrealistic and unnecessary. I urge CMS to expand coverage for counseling to include counseling that is delivered by telephone. Telephone counseling could be provided by the same counselor who saw the smoker during the hospital stay. Alternately, it might be provided by a telephone quitline. CMS has already received a comment from Linda Bailey of the North American Quitline Consortium that summarizes the evidence to support this method of delivering smoking counseling.

I strongly urge CMS to incorporate into the new benefit smoking cessation counseling for smokers who are hospitalized for a medical reason. Doing so will increase Medicare’s positive impact on the health of the elderly population by reaching smokers at a time when cessation counseling can be very effective and cost-effective.

If you have any questions about this matter, please feel free to contact me.

Sincerely,

References

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January 21, 2005

Mark McClellan, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Dear Dr. McClellan:

On behalf of the Center for Tobacco Cessation, we respectfully submit the following comments for your consideration regarding the Centers for Medicare & Medicaid Services’ (CMS’) proposed decision to cover smoking and tobacco use cessation counseling, CAG 00241N, as released on the CMS website on December 23, 2004 (https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=130).

The Center for Tobacco Cessation (CTC) is an organization focused solely on tobacco cessation issues. The CTC serves as a source of the best available science on cessation and helps smokers quit by partnering with business, healthcare, and community leaders to promote proven and effective tobacco cessation treatments and policies. The program, based in Washington, D.C., is supported by the American Cancer Society and the Robert Wood Johnson Foundation.

The CTC informs and advocates for comprehensive tobacco cessation services’ coverage for anyone addicted to tobacco who is ready to quit. According to the U.S. Surgeon General, 440,000 deaths a year are caused by tobacco use. Cancer is just one of the many diseases that are inextricably linked to tobacco use¹ and disproportionately affect the elderly. We know that no matter when a smoker quits it can help curtail or even reverse some of the damage done by their use of tobacco. It, therefore, is in our nation’s interest to ensure access to comprehensive tobacco cessation services for America’s seniors. Thus, the CTC fully supports CMS in its proposed decision to cover tobacco cessation counseling services under Medicare. This coverage is an important next step to helping some of the most effected of the millions of Americans who suffer from tobacco addiction.

While we strongly support the proposed coverage, we would like to address three important issues which we feel require clarification and comment:

1. Availability of treatments covered to ensure maximum flexibility for combination of therapies.
2. Restrictions on which beneficiaries are covered for services.
3. Training requirements for applicable providers for services.

Tobacco cessation treatments available for coverage

Our recommendation for a comprehensive benefit for tobacco cessation follows the guidelines of the Public Health Service’s (PHS) Clinical Practice Guideline.² Patients with access to all forms of treatment achieve the greatest success rates in smoking cessation. Success rates double, and may even triple, when both counseling and drug therapies are applied together. A comprehensive benefit should include counseling, pharmacotherapy, and assistance for clinician intervention and systems-based interventions. Coverage should allow a combination of these treatments and follow these recommended guidelines:

1. Provide practical counseling that includes problem solving and skills training.
2. Teach individuals to enlist outside support from friends, family and co-workers.
3. Provide individual, group or telephone counseling, focusing on person-to-person support.

• Nicotine Gum (e.g. Nicorette)
• Nicotine Patch (e.g. Nicoderm CQ, Nicotrol Habitrol)
• Nicotine Inhaler (e.g. Nicotrol Inhaler)
• Nicotine Nasal Spray (e.g. Nicotrol NS)
• BupropionSR (e.g. Zyban)
• Nicotine Lozenge (post-publication addition) (e.g. Commit)

The CTC wishes to recognize CMS for its role in implementing the first important step toward easing the tobacco burden to America’s seniors, coverage for prescription pharmacotherapies for tobacco cessation beginning in January 2006. We urge CMS to ensure that the implementation of the proposed counseling benefit is executed so as to maximize the availability and impact of both counseling and pharmacotherapy services. Though, it is our understanding that under the new prescription drug benefit, Medicare will cover drugs that may only be dispensed with a prescription, we hope that CMS would also ensure coverage for smoking cessation agents prescribed by a physician that are also available over-the-counter i.e., nicotine replacement patches.

Although the majority of Medicare beneficiaries who smoke may qualify for the proposed coverage, the limitation of patients with currently diagnosed with tobacco linked disease or health effect (or those taking a therapeutic agent affected by tobacco use) is concerning. The Centers for Disease Control and Prevention (CDC) and the PHS have defined tobacco dependence as a chronic condition and should therefore be treated as such. By addressing the dependence of tobacco by those beneficiaries who currently smoke but who have yet to develop a diagnosed-disease related to smoking, CMS will be able to save millions of dollars and prevent hundreds of thousands of premature deaths due to smoking. Coverage for tobacco dependence itself is key to these savings.

Providers eligible for administering tobacco cessation services and the training requirement

The CTC would like to ask for clarification on the training requirements stipulated in the proposed decision, “The counseling may only be provided by individuals trained in tobacco use cessation counseling.” Existing guidelines for evidence-based tobacco cessation services make training feasible and compliance with those guidelines should be a part of any training curriculum or certification. We encourage CMS to work with experts and stakeholders within the tobacco control community, both Administration partners such as the CDC and the National Cancer Institute and private partners such as the American Cancer Society to define and develop these training requirements for various providers.

Conclusion

Cancer is just one of the many tobacco-related diseases that disproportionately affect the elderly—according to National Cancer Institute data and the American Cancer Society’s 2004 Facts & Figures, nearly 60 percent of all new cancer diagnoses and 70 percent of all cancer-related deaths occur in this population. Given the importance of tobacco use cessation for the treatment of cancer patients and the prevention of further incidence of cancer and the many other diseased related to tobacco use, CTC appreciates the opportunity to provide you with comments on the proposed counseling benefit and looks forward to working with you and your staff as this new benefit is implemented. We offer our assistance to meet our mutual goals of improving the health and reducing the disparate burden of tobacco carried by Medicare beneficiaries.

Sincerely,

/s/
William L. Furmanski

cc: Steve Phurrough, MD, MPA, Director, Coverage and Analysis Group
Marcel Salive, MD, MPH, Director, Division of Medical and Surgical Services
William Larson, Policy Analyst
Jyme Schafer, MD, MPH, Medical Officer
Clay Farris, Policy Analyst

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January 21, 2005

Marcel Salive, MD, MPH
Director, Division of Medical & Surgical Services
Coverage and Analysis Group
7500 Security Boulevard - C1-09-28
Baltimore, Maryland 21244

RE: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N)

Dear Dr. Salive:

Thank you for the opportunity to comment on the December 23, 2004, memorandum from the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare. My comments reflect 25 years of experience as an researcher in smoking cessation and tobacco control, as a practicing internist who has cared for many Medicare recipients with tobacco-related disease, and as Past President of the Society for Research in Nicotine and Tobacco (SRNT), the leading international society of investigators in this field.

First, I want to express strong support for the CMS proposal. This new policy will provide enormous benefit to Medicare beneficiaries in reducing and preventing tobacco-related disease.

My specific concern is that the draft memorandum does not appear to provide a mechanism to cover smoking cessation counseling for Medicare beneficiaries who are hospitalized for acute illness. This is a major gap, because hospitalization provides a unique teachable moment when smokers are especially receptive to cessation interventions. Smoking cessation counseling that starts at the bedside during hospitalization and continues after discharge (usually by proactive telephone contacts) has been shown to increase smoking cessation rates in randomized controlled clinical trials.(1-7) The efficacy of counseling is enhanced by providing nicotine replacement therapy during hospitalization and continuing it after discharge.(8) A meta-analysis from the Cochrane Database of Systematic Reviews concludes that intensive smoking cessation counseling that begins during hospitalization and continues for more than 1 month after discharge increases smoking cessation rates by 82% compared to a control condition.(9-10) The effect is strongest in smokers who are admitted for acute myocardial infarction (MI), but the data demonstrate efficacy of this approach even when generalized to all hospitalized smokers.

Furthermore, cost-effectiveness studies have demonstrated that delivering these services are highly cost-effective. A cost-effectiveness analysis of patients admitted with acute MI found that counseling inpatient smokers was highly cost-effective, more cost-effective than providing beta-blockers after MI.(11) The reason is that (1) smoking cessation reduces post-MI morbidity and mortality by 30-50%, (2) counseling is relatively inexpensive and is required for only a short time (unlike a medication), and (3) post-MI patients are at high risk for incurring future high medical costs due to the nature of coronary heart disease. A similar cost-effectiveness study was done for all hospitalized patients, regardless of diagnosis, and also reported that providing the service was very cost-effective.(12)

This evidence base has led to broad support for incorporating smoking cessation counseling for hospital inpatients. It is included as a recommendation in the 2000 U.S. Public Health Service Guidelines for Treatment of Tobacco Use and Dependence. It has been adopted by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) as a measure for assessing the quality of care provided to patients hospitalized with acute MI, congestive heart failure, and community-acquired pneumonia. CMS has also adopted a very similar performance measure.

The JCAHO quality measure has been in use since 2002. In general, hospitals are falling short on it compared to their compliance with other measures such as the use of aspirin or beta-blockers after MI. A major reason has been the challenge of paying for the bedside counseling and the follow-up telephone counseling. I know from personal experience in my institution and from conversations and consultations from colleagues nationwide that this is a major barrier to improving the quality of care provided to hospital patients. Given this strong evidence base and the regulatory imperative from CMS, it is essential that Medicare’s decision about covering smoking cessation counseling extend to cover hospitalized patients who would be included if they were outpatients. In other words, I urge CMS to develop an appropriate mechanism to cover this care.

I propose that Medicare cover smoking cessation counseling services for an eligible recipient whether the beneficiary receives services as an outpatient or is hospitalized for a medical reason. This inpatient coverage would be different from the “resident” program described in the Proposed Coverage Decision. My proposal is one-time inpatient counseling while the beneficiary is hospitalized. As mentioned earlier, this intervention is especially important because of the patient’s receptivity to counseling.

As I understand it, the proposed coverage is now intended to be a Part B service. The problem is that hospital care by hospital employees is billed through Part A using DRGs rather than based on services provided. It may be that physicians could provide smoking counseling to inpatients as a Part B service, but that is not clear in the memorandum. However, it is not practical or cost-effective to have smoking counseling in hospital settings delivered by physicians. In the studies that demonstrated the efficacy and cost-effectiveness of hospital-initiated smoking counseling, the counselors were trained nurses and other counselors, usually with a background in social work, counseling, or health education. What unified them was a formal training program in smoking cessation counseling. I urge CMS to identify a mechanism by which smoking counseling in an inpatient setting could be designated as a medically necessary covered service that would be covered when delivered by a range of trained counselors in addition to physicians.

I also propose that the coverage for smoking cessation counseling services be extended to cover counseling that is provided by telephone. Effective hospital-initiated smoking interventions uniformly included a structured proactive telephone counseling program after discharge. Requiring recently hospitalized elders, many of whom are homebound, to return to a health care facility in order to receive smoking counseling face-to-face is unrealistic and unnecessary. I urge CMS to expand coverage for counseling to include counseling that is delivered by telephone. Telephone counseling could be provided by the same counselor who saw the smoker during the hospital stay. Alternately, it might be provided by a telephone quitline. CMS has already received a comment from Linda Bailey of the North American Quitline Consortium that summarizes the evidence to support this method of delivering smoking counseling.

I strongly urge CMS to incorporate into the new benefit smoking cessation counseling for smokers who are hospitalized for a medical reason. Doing so will increase Medicare’s positive impact on the health of the elderly population by reaching smokers at a time when cessation counseling can be very effective and cost-effective.

If you have any questions about this matter, please feel free to contact me.

Sincerely,

Nancy Rigotti, MD

Director, Tobacco Research & Treatment Center, Massachusetts General Hospital
Associate Professor, Harvard Medical School
Co-Chair, Task Force on Smoking Cessation, Partners Health Care Inc.
Past President, Society for Research in Nicotine & Tobacco

References

1. Taylor CB, Houston-Miller NH, Killen JD, DeBusk RF. Smoking cessation after acute myocardial infarction: Effects of a nurse-managed intervention. Ann Intern Med 1990;113:118-123.

2. Burt A, Illingworth D, Shaw T, Thornley P, White P, Turner R. Stopping smoking after myocardial infarction. Lancet 1974; 1(7852):304-306.

3. Simon, J. A., Solkowitz, S. N., Carmody, T. P. & Browner, W. S. Smoking cessation after surgery. A randomized trial. Archives of Internal Medicine 1997;157:1371-6.

4. Miller NH, Smith PM, DeBusk RF, Sobel DS, Taylor CB. Smoking cessation in hospitalized patients - results of a randomized trial. Arch Intern Med 1997;157:409-415.

5. Rigotti NA, Arnsten JH, McKool KM, Wood Reid KM, Pasternak RC, Singer DE. Efficacy of a smoking cessation program for hospital patients. Arch Intern Med 1997;157:2653-2660.

6. Stevens VJ, Glasgow RE, Hollis JF, Lichtenstein E, Vogt TM. A smoking-cessation intervention for hospital patients. Med Care 1993;31:65-72.

7. Simon, J. A., Carmody, T. P., Hudes, E. S., Snyder, E. & Murray, J. Intensive smoking cessation counseling versus minimal counseling among hospitalized smokers treated with transdermal nicotine replacement: a randomized trial. Am. J. Med 2003;114: 555-562.

8. Molyneux A., Lewis S., Leivers U., Anderton A., Antoniak M., Brackenridge A., Nilsson F., McNeill A., West R., Moxham J., Britton J. Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. Thorax 2003;58:484-488.

9. Munafo, M., Rigotti, N., Lancaster, T., Stead, L. & Murphy, M. Interventions for smoking cessation in hospitalised patients: a systematic review. Thorax 201;56: 656-63.

10. Rigotti, N. A., Munafo, M. R., Murphy, M. F. & Stead, L. F. Interventions for smoking cessation in hospitalised patients.[update in Cochrane Database Syst Rev. 2003;(1):CD001837; PMID: 12535418]. Cochrane Database of Systematic Reviews (2001).

11. Krumholz HM, Cohen BJ, Tsevat J, Pasternak RC, Weinstein MC. Cost-effectiveness of a smoking cessation program after myocardial infarction. J Am Coll Cardiol. 1993;1697-1702.

12. Meenan RT, Stevens VJ, Hornbrook MC, LaChance PA, Glasgow RE, Hollis JF, Lichtenstein E, Vogt TM. Cost-effectiveness of a hospital-based smoking cessation intervention. Med Care 1998;36:670-678.

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Re: Proposed Coverage Decision Memorandum: NCA for Smoking & Tobacco Use Cessation Counseling (CAG-00241N)
This letter is being submitted on behalf of the Association for the Treatment of Tobacco Use and Dependence (ATTUD), an organization dedicated to the promotion of and increased access to evidence-based treatment for the tobacco user. The organization is made up of treatment professionals from across the US, as well as several members from other countries. ATTUD strongly supports the proposal by the Centers for Medicare and Medicaid Services (CMS) to cover tobacco-counseling services under Medicare. As health professionals who encounter, on a daily basis, the deadly toll of smoking on American citizens, ATTUD commends CMS for improving treatment benefits for those covered by Medicare. Supported by rigorously tested evidence for tobacco treatment and counseling, this decision will aid thousands of Medicare beneficiaries to access assistance to quit smoking. The recommendation to cover moderate to intensive counseling may be especially appropriate for seniors with a long history of smoking and potentially high levels of addiction. As a result, more seniors will quit smoking and their health outcomes will improve.

The proposed coverage of counseling services will be an historic step in the effort to reduce tobacco use. This is a forward-thinking step, and one that is a true example of translating research into practice.ATTUD believes this CMS decision can be strengthened by the following:

CMS needs to provide comprehensive tobacco dependence treatment to Medicare recipients using tobacco products. Tobacco cessation services play a critical role among patients willing to stop using tobacco; they effectively support the patient’s psychological withdrawal symptoms in a group of individual counseling settings. Furthermore, research has supported tobacco cessation as an effective tool to minimize tobacco using rates among various populations when combined with nicotine replacement therapies.

The PHS Guidelines for Treating Tobacco Use And Dependence have established guidelines for healthcare providers and other certified lay people who want to provide tobacco cessation services to their community members wanting to stop using tobacco. Therefore, it is important to offer training and certification programs that have been proven to be effective, sustainable and adaptable to diverse populations and cultures. In El Paso, Texas the Arizona model developed and implemented since 1998 to certify lay people and clinicians, was adopted at various primary care clinics such as Centro San Vicente, and the Texas Tech Community Partnerships clinics. These trained clinicians, health educators and promotoras have been able to offer consistent tobacco cessation services in individual and group settings to underserved, uninsured patients. Patients have been responsive to the comprehensive tobacco cessation services being offered at these clinics; thereby supporting the patients’ efforts to reduce their cigarette intake or their quit attempt.

I encourage CMS to review certification programs and incorporate a plan for national certification in the proposed Decision (CAG-00241N) as these certification programs provide a consistent foundation of support and knowledge for clinicians and lay health workers.

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This comment is being submitted on behalf of the Alliance for the Prevention and Treatment of Nicotine Addiction (APTNA), a nonprofit training and consultation organization dedicated to promoting tobacco use cessation in the state of Virginia.

APTNA strongly supports the proposal by the Centers for Medicare and Medicaid Services (CMS) to cover tobacco counseling services under Medicare. The decision by CMS will have a significant, positive impact on the health of millions of seniors for many years to come.

APTNA believes this CMS decision can be strengthened by the following:

• Extend coverage of pharmacotherapy to include all FDA approved tobacco use cessation medications, even OTC products such as nicotine replacement gum and patches, when there is evidence of participation in a covered tobacco use cessation counseling service with an approved provider. These OTC medications are efficacious, less expensive than prescription medications and easily accessed. Our experience has been that health care providers are much more likely to intervene with tobacco users and offer cessation advice during office/clinic visits and hospitalizations when there is another cessation resource to which they can refer patients for counseling. Quitlines offer the most stable, consistent source for follow-up cessation services.
• Extend treatment coverage to include telephone counseling services that are provided by appropriately trained individuals able to demonstrate competency. This mode of treatment for tobacco use and dependence has been shown to be clinically effective and cost effective and has the potential for wide reach among all populations, including seniors. In addition, an infrastructure already exists for this modality, at the federal level, and a national organization (the North American Quitline Consortium) is already providing assistance to facilitate implementation of a quitline in every US state.
• Ensure that covered counseling services are provided by individuals able to demonstrate competency through receipt of appropriate training, education and clinical supervision. Appropriate should be defined as specific to tobacco use and dependence and encompassing standards of practice developed by expert consensus, such as those developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD). Demonstration of competency should, in the near future, be through a required certification when the credentialing body is able to prove that development of the credential complied with a valid, accepted procedure (as defined by a credible source such as the International Certification Accreditation Board).
• Extend coverage to all seniors, regardless of current medical condition or symptoms, by adding coverage of cessation counseling as a mental health service for seniors who meet any of the following diagnoses: Tobacco Use Disorder (ICD-9), Tobacco Dependence Syndrome (ICD-10), Nicotine Dependence (DSM-IV), or Nicotine Withdrawal (DSM-IV).

Thank you for the opportunity to provide comments on this important health care issue. APTNA commends CMS for taking action that will save thousands of lives and improve the quality of life for US seniors.

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On behalf of the Partnership For A Tobacco-Free Maine, Bureau of Health, Maine Department of Health and Human Services, I want to thank you for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling.

Overall, we strongly support CMS’ decision to expand coverage for tobacco treatment counseling under Medicare. The decision will have a positive health impact on the large population of seniors in Maine. We are particularly concerned, however, that the decision did not adequately address the evidence that supports the effectiveness of telephonic quitlines in treating tobacco use and dependence. A number of well-designed studies have demonstrated that proactive quitlines provide counseling in a manner that results in improved quit rates. This evidence should be sufficient for CMS to conclude that proactive quitlines are “reasonable and necessary”.

The following information should be proof of the value of proactive quitlines and the importance of including them in a benefit category for Medicare recipients:

I am writing on behalf of the American Psychological Association (APA), the professional organization representing more than 150,000 members and associates engaged in the practice, research and teaching of psychology. APA commends the Centers for Medicare and Medicaid Services (CMS) for proposing to cover tobacco cessation counseling for beneficiaries suffering from disease or adverse health. As CMS has noted, tobacco usage is the leading cause of preventable death in the United States.

Counseling for individuals has been demonstrated to be an effective intervention to achieve tobacco cessation. Psychologists, who have on average over seven years of graduate education in human behavior, are ideally suited to use their counseling skills to help people quit smoking. In the draft decision memo outlining this proposal, CMS cites a study that found psychologists had the highest rate of effectiveness among various healthcare practitioners, including physicians, in providing smoking cessation services . Accordingly, APA requests that when finalizing this proposal CMS identify psychologists as being among the healthcare practitioners qualified to provide tobacco cessation counseling.

APA would be happy to work with CMS to help implement such an important new benefit. I invite you to contact our Director of Regulatory Affairs, Diane M. Pedulla, J.D., at (202) 336-5889 for more information.

Mojica WA, Suttorp MJ, Sherman SE, et al. Smoking cessation interventions by type of provider, a meta-analysis. American Journal of Preventive Medicine 2004; 26:391-401.

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This letter is being submitted on behalf of the Center for Tobacco Prevention and Control within the Division of Preventive and Behavioral Medicine at the University of Massachusetts Medical School (UMMS). We have a long history of conducting research related to tobacco treatment and prevention and have provided state of the art tobacco treatment training to health professionals since 1993. We strongly support the proposal by the Centers for Medicare and Medicaid Services (CMS) to cover tobacco counseling services under Medicare. We commend CMS for the thorough investigation into the existing evidence supporting tobacco treatment and counseling. This decision will aid thousands of Medicare beneficiaries to access assistance to quit smoking and will contribute to improved health outcomes for our nation’s increasing number of senior citizens. We appreciate the opportunity to comment on the proposal and would like to offer suggestions about the following aspects of the proposal:

On behalf of Providence Health System, I would like to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling.

Providence strongly supports the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare. The decision by CMS will have a significant, positive impact on the health of millions of seniors for many years to come.

Coverage of inpatient smoking cessation services

From our understanding of the draft national coverage decision memorandum, smoking cessation services could be eligible for Medicare coverage when they are provided as:

NACDS is pleased to provide comments regarding the proposed Medicare coverage of smoking-cessation counseling. NACDS represents more than 200 chain pharmacy companies operating almost 32,000 community retail pharmacies. Our industry is the primary provider of outpatient pharmacy services in the United States, providing about 70 percent of all retail prescriptions. Community retail pharmacies are easily accessible to all patients, and are especially convenient for Medicare beneficiaries who might find other health care providers difficult to access. Therefore, we feel that the proposed coverage of smoking-cessation counseling to our nation’s seniors should explicitly include community retail pharmacies as providers.

Pharmacy-Based Smoking Cessation Success: Evidence demonstrates the success of pharmacy-based smoking-cessation programs. A 2002 study published in the Journal of the American Pharmaceutical Association showed that smoking-cessation demonstration programs set-up at Target pharmacies in Virginia achieved even greater success than previous interventions in other settings.¹ Moreover, the highest cessation rate (individuals who had completely quit smoking after a one year follow-up) of 33.3 percent was observed among patients aged 20-29 and those over 50. This proves the value of pharmacy-based counseling, especially to seniors who are the target of this coverage decision.

Pharmacy-Based Smoking Cessation is a Cost-Effective Service: In addition to evidence thatpharmacy-based smoking-cessation counseling works, studies also show that it is a cost-effective approach to quitting smoking. Studies done concerning the cost-effectiveness of smoking-cessation programs have shown that based on the product cost (nicotine gum, nicotine patch, and bupropion), pharmacist time, technician support, material costs, and the overall success of cessation (completely quitting smoking), pharmacy-based smoking-cessation programs are even more cost-effective than self-directed quit programs².

Because many patients visit their local pharmacy already to fill other prescriptions, patients would not be required to visit their physician multiple times or to visit a separate clinic simply to receive counseling. They could receive support from their pharmacist while they are waiting for their prescription to be filled. This would limit any additional travel costs or co-pays that might be imposed on patients.

Medicare Modernization Act Prescription Drug Coverage: Another important fact to consider regarding the inclusion of pharmacists as providers under this coverage decision is that certain smoking-cessation drugs will be covered under the new Medicare Prescription Drug Benefit, which is scheduled to take effect in January of 2006. This is important because once implemented, this benefit could lead to more Medicare beneficiaries going to their local community pharmacies to obtain such medications, making pharmacists logical practitioners of smoking-cessation counseling.

Lack of Reimbursement Limits Success: Studies have shown thatone reason why smoking-cessation programs are not more widespread in the community pharmacy setting is a lack of reimbursement for the service. Many private insurers currently cover smoking cessation aids such as nicotine gum and/or the nicotine patch, but few actually cover counseling as a service. Therefore, pharmacists must provide this service without compensation even though it results in better health for patients and reduces health care costs for plans.

A study published in the Journal of Community Health surveyed Indiana pharmacists and asked whether they inquired about their patients’ smoking habits. Only about one fourth (27%) of respondents said that they did in fact ask their patients about their smoking habits. The most frequently cited barrier to inquiring and attempting to provide counseling was job-time constraint followed by lack of reimbursement for services³. Despite these barriers, nearly three fourths of the pharmacists surveyed said that their pharmacy offered some kind of smoking-cessation counseling service to customers. This success rate would likely increase if third-party insurers provided reimbursement to pharmacists who provide smoking-cessation services.

The Delaware Pharmacists Society (DPS) currently reimburses trained Delaware pharmacists who provide smoking-cessation counseling to patients. Reimbursement for this service is provided at the following rates: Initial Assessment: $45.00; First Follow-up: $20.00; Second Follow-up: $20.00; with an $85.00 maximum reimbursement per patient. Both follow-ups must be completed within 6 weeks of the patient’s quit date. Face-to-face counseling is required for the Initial Assessment and preferred for the follow-ups. Telephone follow-ups will be accepted if it is more convenient for the patient.

This program is an example of a successful pharmacy-based smoking-cessation program to which CMS could model Medicare coverage after.

Conclusion

Being among the most trusted and accessible health care professionals, pharmacists are in an ideal position to assist all patients, including Medicare beneficiaries, who wish to quit smoking. Medicare coverage of smoking-cessation counseling is an important first step to helping more and more individuals reap the health benefits of quitting smoking. NACDS applauds CMS for taking the initiative to provide coverage for such an important service. In order for this service to be as successful as possible, we feel that coverage decision should be explicitly extended to pharmacy-provided counseling.

¹ “Results of a Smoking Cessation Clinic in Community Pharmacy Practice,” Kennedy, Giles, Chang, Small, and Edwards, Journal of the American Pharmacists Association, Vol. 42, No.1, January/February 2002.

² “Modeling the Cost-Effectiveness of a Smoking-Cessation Program in a Community Pharmacy Practice,” Tran, Holdford, Kennedy, Small, MedScape, posted January 23, 2003.

³ “A Survey of Pharmacists’ Opinions and Practices Related to the Sale of Cigarettes in Pharmacies—Revisited,” Kotecki and Hillery, Journal of Community Health, Vol. 27, No. 5, October 2002.

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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’) proposed decision to cover smoking and tobacco use cessation counseling, CAG-00241N, as released on the CMS website on December 23, 2004 (https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=130).

The Society applauds CMS for taking this important first step in easing the tobacco burden on America’s seniors. Tobacco cessation has long been and continues to be one of the Society’s nationwide priorities for reducing the incidence and mortality of all cancers as well as those from tobacco-related disease. Because cancer is a disease that disproportionately affects the elderly,¹ and because one-third of all cancers are caused by tobacco use,^2,3 it has been the Society’s strong interest that our nation’s seniors have access to comprehensive tobacco cessation services. The Society fully supports CMS in its proposed decision to cover tobacco cessation counseling services under Medicare and looks forward to the agency’s coverage of prescription pharmacotherapies for tobacco cessation in January 2006.

The Society welcomes the opportunity to work with CMS on future steps to reduce tobacco among the Medicare population, as well as among those beneficiaries covered under other federal health programs. The current draft proposal extends tobacco cessation benefits to Medicare patients suffering from a “disease or adverse health effect that has been found by the U.S. Surgeon General to be linked to tobacco use.”⁴ However, it is the Society’s strong preference that all patients have access to tobacco cessation counseling, when they are ready to quit and irrespective of a tobacco-related diagnosed disease. By addressing those beneficiaries who currently smoke but who have yet to develop a tobacco-related disease, CMS will save lives and prevent untold suffering among the nation’s senior population.

Cancer is a disease that disproportionately affects the elderly—according to National Cancer Institute data and the Society’s 2004 Facts & Figures, nearly 60 percent of all new cancer diagnoses and 70 percent of all cancer-related deaths occur in this population. Moreover, tobacco continues to be the leading preventable cause of death in this country. Therefore, as the nationwide voluntary health organization committed to eliminating cancer as a major health problem, the American Cancer Society has a particular interest in ensuring that our nation’s seniors have access to high quality cancer prevention, early detection, and treatment tools through the Medicare program. Given the importance of tobacco use cessation for the prevention of cancer and the treatment of cancer patients, the Society appreciates the opportunity to comment on this proposal. We thank CMS for its leadership on this very important issue and stand ready to work with you and your staff to meet our mutual goals of improving the health and reducing the cancer burden among Medicare beneficiaries.

¹ American Cancer Society. Cancer Facts & Figures 2004; National Cancer Institute. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1973-1999. Tables I-11 and I-13.

² Doll R, Peto R. The Causes of Cancer. New York, NY: Oxford Press; 1981.

³ US Department of Health and Human Services. Reducing the Health Consequences of Smoking: 25 Years of Progress. A Report of the Surgeon General. Rockville, MD: US Department of Health and Human Services, Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 1989.

⁴ Centers for Medicaid and Medicare Services (CMS). Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling (CAG-00241N). Available online at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=130.

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On behalf of the members of the American Thoracic Society, the American Association of Cardiovascular and Pulmonary Rehabilitation and the National Association for the Medical Direction of Respiratory Care, we would like to offer our strong support for the Centers for Medicare and Medicaid Services Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling (CAG­00241N). We believe the draft policy is an excellent starting point for making proven and effective tobacco cessation interventions available to Medicare beneficiaries. Helping Medicare beneficiaries quit smoking and use of other tobacco products will improve our nation's health and lower overall Medicare expenditures.

The American Thoracic Society (ATS) represents physicians, researchers and allied health professionals who are actively engaged in diagnosis, treatment, training, and research of tobacco-related diseases. The ATS recently published, with our international partner the European Respiratory Society, a revised version of the statement: Standards for the Diagnosis and Management of Patients with COPD. The statement represents the combined scientific knowledge and expert opinion on the optimum care of patients with COPD — a disease most commonly caused by tobacco use.

The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) is dedicated to the professional development of its members, through networking and educational opportunities. AACVPR is comprised of all professionals who serve in the field of cardiac and pulmonary rehabilitation and members include: cardiovascular physicians, exercise physiologists, cardiopulmonary physical therapists, pulmonary physicians, cardiac nurses, dieticians, and respiratory therapists.

The National Association for Medical Direction of Respiratory Care (NAMDRC) represent pulmonologists who serve as medical directors of respiratory care departments, critical care units, and pulmonary rehabilitation programs in 2,000 hospitals nationwide.

Smoking Cessation Benefits Should Be Available for All Medicare Beneficiaries

We believe that tobacco cessation benefits to should be available to all Medicare beneficiaries, regardless of whether they yet have evidence of tobacco-related disease or not. Tobacco use is bad for your health whether you are currently exhibiting tobacco-related symptoms or not. More than half of long-term smokers will eventually develop serious smoking-related diseases. The goal of smoking cessation is to stop disease before it starts or prevent disease from progressing further. A Medicare policy that requires patients to exhibit tobacco related-disease before they could receive Medicare covered tobacco cessation services limits the benefits of smoking cessation.

We recognize, however, that CMS does not have the authority to create new benefits under the Medicare program and we further recognize and applaud CMS for creating a broad Medicare tobacco cessation policy. We encourage CMS to expand tobacco cessation policy to all federally sponsored health programs.

Cessation Counseling Should Be Coordinated with Pharmacotherapies

We recognize that the draft memo addresses only tobacco cessation counseling services. Medicare coverage for pharmacotherapies for tobacco cessation will begin in January 2006. We urge CMS to ensure a coordinated policy that combines and maximizes the effectiveness of counseling and drug therapy to help Medicare beneficiaries quit the tobacco habit.

Cost of Smoking Cessation Should Be Included in the SGR

We strongly recommend that the cost of providing smoking cessation benefits be included in the law and regulation component of the Medicare sustainable growth rate (SGR) formula. Congress specifically intended the SGR to capture the increase costs associated with law and regulatory expansions of the Medicare program — such as the proposed coverage of smoking and tobacco cessation counseling - that lead to an overall increase in physician expenditures.

Tobacco Cessation Counseling Under "Incident To Physician" Benefit Category

We note with interest that the Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling lists the "service furnished as an incident to a physician's professional service" benefit category of the Social Security Act (Section 1861(s)(2)(A)) as the legislative authority for creating the proposed policy. The ATS strongly agrees with CMS rationale for section 1861(s)(2)(A) as a benefit category under which to extend tobacco cessation counseling services to Medicare beneficiaries. Our collective organizations encourage CMS to use the same rationale to extend pulmonary rehabilitation services to all Medicare beneficiaries under section 1861(s) (2) (A).

Again, the undersigned organizations appreciate the opportunity to comment on this important issue. We strongly support the Draft Decision Memo for Smoking & Tobacco Use Cessation Counseling.

Sharon l.S. Rounds, MD
President, American Thoracic Society

Douglas R. Southard, PhD, MPH, PA-C
President, American Association for Cardiovascular and Pulmonary Rehabilitation

Steven M. Zimmet, MD
President, National Association for the Medical Direction of Respiratory Care

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On behalf of the more than 4,600 members of the Pennsylvania Academy of Family Physicians (PAFP), I applaud CMS’ proposal to extend Medicare coverage for smoking cessation counseling to beneficiaries who have a smoking-related disease or who take medicines that are adversely affected by tobacco use.

In fact, helping patients stop smoking is one of the many rewarding aspects of a family physician’s practice.

As CMS considers adding this expanded level of benefits, please consider the following:

• Family physicians are trained in addictions and behavioral health management. In many communities, family physicians are the only medical professionals available to assist patients with their cessation program.

• Clarification is needed regarding what is a “session.” Will phone and face-to-face sessions be counted the same? Will individual and group sessions be counted the same? Is time (or length of session) the only determinant of the distinction between “intermediate” and “intensive” sessions?

• It is important that this coverage adequately reflects the value of physicians’ time and expertise, and that the documentation and coding requirements are not burdensome. After all, the goal is to increase the frequency at which seniors are offered tobacco cessation treatments. This coverage should be an incentive to achieve that goal.

Thank you for the opportunity to comment on this National Coverage Analysis Draft Decision Memo. Family physicians look forward to working with CMS in increasing the number of seniors quitting tobacco. If you have any questions of these comments, please call or email me.

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On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 24 million AHA and ASA volunteers and supporters, we wish to commend the Centers for Medicare and Medicaid Services (CMS) on its proposed National Coverage Decision Memorandum on Smoking & Tobacco Use Cessation Counseling (CAG-00241N).

The AHA has played a leading role in promoting strategies to combat smoking, which is a major preventable cause of cardiovascuar disease and stroke. The AHA strongly supports CMS in its ongoing efforts to improve the health of our seniors through smoking cessation strategies. We urge CMS to finalize and implement the proposed National Coverage Decision Memorandum expeditiously so that Medicare beneficiaries may begin receiving smoking and tobacco use cessation counseling as soon as possible. In addition. we urge CMS to interpret this new coverage policy as broadly as possible to ensure access for all Medicare beneficiaries who could benefit from this important therapy.

Nearly one-third of all coronary heart disease deaths in the United States each year are attributable to cigarette smoking. Tobacco use leads to substantial increases in patient mortality and morbidity from stroke, coronary heart disease, peripheral vascular disease, cancer, chronic lung disease and other chronic diseases.¹

Research indicates that the risk of chronic heart disease diminishes rapidly after quitting smoking. Even smokers who have already developed smoking-related diseases or symptoms benefit from smoking cessation. For example, individuals with coronary heart disease experience as much as 50 percent reductions in risk of re-infarction, sudden cardiac death and mortality if they quit smoking after the first infarction.²

Making smoking cessation counseling widely available to Medicare beneficiaries will assist our nation's seniors in reducing their risks of death and disability from heart disease and stroke. The effectiveness of this new benefit will be enhanced further when Medicare begins covering tobacco cessation drugs under the new Part D prescription drug benefit. The AHA applauds CMS' continuing efforts to improve public health outcomes in this area.

With implementation of this new benefit. Medicare is taking an important step forward. To this end, we urge CMS and the Department of Health and Human Services (HHS) to ensure that all federally­ funded health care programs provide coverage of evidence-based smoking and tobacco cessation treatments. We also urge CMS and HHS to implement all of the recommendations within the National Action Plan for Tobacco Cessation, which was developed for Secretary Thompson by the Subcommittee on Cessation of the Interagency Committee on Smoking and Health.³

1/ Ockene IS, Miller, NH. Cigarette smoking, cardiovascular disease, and stroke: a statement for healthcare professionals from the American Heart Assocation. Circulation. 1997;96:3243-7.

2/ Id.

3/ Fiore MC, Croyle RT, Curry SJ, Cutler CM, Davis RM, Gordon C., Healton C, Koh HK. Orleans CT, Richling D, Satcher D, Seffrin J, Williams C, Williams LN, Keller PA, Baker TB. Preventing 3 million premature deaths and helping 5 million smokers quit: a national action plan for tobacco cessation. Am J Public Health. 2004;94:205-210

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On behalf of the American Medical Association (AMA), I appreciate this opportunity to provide comments on the Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling. The AMA strongly supports the December 23, 2004, announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare.

Medicare's decision will have a significant, positive impact on the health of millions of seniors for years to come. Tobacco continues to be the leading cause of preventable death in the United States. Seniors who smoke cigarettes have a greater risk of acquiring traditional smoking-related illnesses such as lung cancer, heart disease, emphysema and stroke. Studies have shown that seniors who try to quit smoking are 50 percent more likely to succeed than all other age groups, and seniors who quit can reduce their risk of death from heart disease to that of nonsmokers within two to three years after quitting.

While we endorse CMS's proposal, coverage would be limited to a Medicare beneficiary who is "a patient with a disease or an adverse health effect that has been found by the U.S. Surgeon General to be linked to tobacco use, or who is taking a therapeutic agent whose metabolism or dosing is affected by tobacco use as based on FDA-approved information." We urge CMS to broaden its proposal to allow coverage of cessation counseling for any Medicare beneficiary who is a smoker and wishes to quit. Nicotine addiction is a disease. Medicare covers services that are reasonable and necessary to treat diseases and therefore should treat nicotine addiction due to smoking.

The risks of tobacco use are compounded by the addictive nature of tobacco products and nicotine, and the difficulty in quitting that this generates for users. Drug addictions or dependencies are widely recognized to be chronic relapsing disorders for which there is wide variation across individuals in their ability to achieve and sustain abstinence. Tobacco is no different from other addicting substances in this regard except that most patients who take drugs that can be addictive are not actually addicted, whereas the majority of tobacco users are daily users and do show signs of addiction. Tobacco dependence is recognized by health professionals worldwide through its classification and coding in the International Classification of Diseases (ICD-9 and 10) and the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV: 305.10 and 292.0). In recognition of this fact, as of December 2002, 36 State Medicaid programs covered some tobacco-dependence counseling or medication for all their Medicaid recipients. We believe that CMS should follow their example.

CMS's proposal would require that cessation counseling "may only be provided by individuals trained in tobacco use cessation counseling." While a variety of training opportunities for providers exist, there are no standards in the field for what might be considered an acceptable level of training. We urge CMS to work with experts and stakeholders in the tobacco control community to define the appropriate level of training required.

While this proposed coverage decision only addresses counseling services, we urge CMS to ensure that implementation of the counseling benefit is coordinated with access to the prescription pharmacotherapies for tobacco cessation that will become available to all Medicare beneficiaries in January 2006 under the Medicare Modernization Act. Beneficiaries should have access to tobacco cessation products prescribed by their physicians.

We understand that at times smoking cessation counseling would be initiated while a smoker is hospitalized. We suggest, therefore, that the details of the coverage and payment policy for this service provide for the possibility that the counseling could be covered by Medicare when provided in the inpatient setting.

Finally, we reiterate our previous comments to CMS, submitted in an August 3, 2004, letter to Mr. Herb Kuhn and Dr. Sean Tunis, that the costs of a decision by CMS to cover cessation counseling in Medicare should be recognized in the law and regulation factor of the Sustainable Growth Rate (SGR). Physicians should not have to be concerned that they will contribute to future Medicare pay cuts each time they provide these highly effective services. These and other services subject to evidence-based national Medicare coverage policy decisions must be recognized in the law and regulation factor of the SGR so that the SGR does not become a disincentive to appropriate utilization of effective physician services.

In conclusion, the AMA applauds CMS' decision as an excellent step towards implementing the recommendations in the National Action Plan for Tobacco Cessation. We offer our assistance as CMS finalizes and implements Medicare coverage for smoking and tobacco use cessation counseling.

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We are aware that The Centers for Medicare and Medicaid Services (CMS) have proposed new Medicare coverage to establish smoking and tobacco cessation counseling. With this letter please find enclosed a copy of our comments on the proposed decision.

We have reviewed these comments in light of the impact on our hospital and utilized an outside consulting firm to assist us in evaluating these regulations. We believe our comments will improve the decision summary.

The following comments are provided regarding the proposed decision summary published in the Medicare Coverage Database on December 23, 2004 to establish smoking and tobacco cessation counseling as a covered benefit for Medicare beneficiaries.

1. The decision memo states the smoking and tobacco cessation counseling may only be provided by individuals trained in tobacco use cessation counseling. On pages 3 and 4 of the Decision Summary the benefit categories for smoking cessation counseling are further stated to be:
   • Physician Services.
   • Services furnished incident to a physician’s professional service.
   • Outpatient hospital services.
   • Rural health clinic services and federally qualified health center services.
   • Services which would be physicians’ services if furnished by a physician and which are performed by a physician assistant, nurse practitioner, or clinical nurse specialist.
   • Qualified psychologist services.
   • Clinical social worker services.

   It is recommended the statement regarding qualified individuals trained in tobacco use cessation be further detailed and clarified. The clarification is particularly needed in the benefit category of “outpatient hospital services” in which services are furnished on a physician’s order by hospital personnel and are under hospital medical staff supervision. In this particular benefit category, or other applicable benefit category listed above, it is recommended that the qualified personnel include all persons licensed by the state in which services are provided to deliver counseling or therapy services and are properly trained in tobacco use cessation. These may include, but are not limited to, Licensed Mental Health Counselors (LPHCs), Masters Level Social Workers (MSW’s), and Certified Addiction Professionals (CAP’s).

2. Patients presenting for smoking and tobacco cessation counseling often will have been recently treated within inpatient programming or outpatient services inside a hospital facility. Because of this close relationship to other medical treatment services in hospital settings, it is recommended that benefit coverage include facility-based (APC) reimbursement for smoking and tobacco cessation counseling in hospital-based outpatient departments, when furnished on a physician’s order, under hospital medical staff supervision, and by personnel properly trained in tobacco use cessation and licensed by the state to deliver counseling or therapy services.

3. Please advise concerning state or national accreditation bodies that allow for training and/or certification in tobacco use cessation counseling.

4. The Decision Summary proposes that Medicare cover smoking and tobacco use cessation counseling only when associated with a disease or an adverse health effect that has been found by the U.S. Surgeon General to be linked to tobacco use, or who is taking a therapeutic agent whose metabolism or dosing is affected by tobacco use based on FDA-approved information. The serious health consequences resulting from tobacco use are clearly evident. As detailed in the Decision Summary smokers often report worse physical and mental functional status than people who never smoked, and smoking affects the function of the immune system, as well as promotes higher levels of chronic inflammation. Because of the immense adverse health affects of smoking, it is recommended that coverage for smoking and tobacco use cessation counseling should be available to all Medicare recipients. The use of cessation counseling should be as ordered by a physician and not be limited to certain diseases, or limited by the necessary association to certain therapeutic agents.

5. The Decision Summary proposes that Medicare cover 2 cessation attempts per year. Each attempt may include a maximum of four intermediate or intensive sessions, with the total annual benefit covering up to 8 sessions in a 12 month period. The research data listed on Page 11, Tables 2 and 3 of the Decision Summary indicates the most success in estimated abstinence rates are achieved at total contact times of up to 300 minutes, and entail greater than 8 cessation sessions. It is recommended that Medicare cover 2 cessation attempts per year, but that each attempt may include a maximum of eight (8) intermediate or intensive sessions, with the total annual benefit covering up to sixteen (16) sessions in a 12 month period.

6. The Decision Summary states that CMS will provide well-defined and unique codes to allow for the evaluation of a per-capita rate for services provided. It is recommended that the unique codes provided by CMS include codes available for group service capabilities. Group care establishes a peer synergy among patients in the treatment and recovery process. This flexibility will allow for the physician and/or therapist to tailor the individual patient’s needs to the most beneficial treatment plan.

7. Generally in this type of counseling setting patients are seen by physicians/therapists in intermediate time settings of 20 to 30 minutes per session, or in intensive time settings of 45 to 60 minutes per session. In a counseling environment the time requirement to establish treatment modalities and goals with the patient requires time considerations of more than 10 to 20 minutes per session. It is recommended the intermediate time settings per cessation session be established at 20 to 30 minutes, and recommended the intensive time settings per cessation session be established at 45 to 60 minutes. The corresponding fee schedule reimbursement rates should be reflective of these professional time requirements.

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These comments are submitted in response to the December 23, 2004, request for public comment on the draft decision memo for smoking and tobacco use cessation counseling.

We commend the Centers for Medicare & Medicaid Services (CMS) for its decision to propose expanding the tobacco cessation benefits available to Medicare beneficiaries. This is an important first step towards prevention of the many adverse health effects associated with tobacco use. Together with the brief counseling already covered by Medicare, the proposed four intensive sessions per cessation attempt would provide access to another benefit proven effective in tobacco-use cessation, as described in the U.S. Department of Health and Human Services, Public Health Service (PHS) Clinical Practice Guideline, Treating Tobacco Use and Dependence.

The CMS proposal has the potential to have a greater impact in preventing tobacco-related disease among older smokers if it were to be extended to all smokers who qualify for Medicare, rather than being limited to those who smoke and have been diagnosed with a smoking related disease or are taking certain drugs whose metabolism is affected by tobacco use.

We conducted some analyses to attempt to ascertain the extent of the population served by the proposed benefit. These data 1/ suggest that approximately two-thirds of Medicare beneficiaries who smoke would be eligible for this benefit; however this still leaves about one million smoking beneficiaries who would not be eligible. Given the proven health benefit of smoking cessation for all smokers, extending the benefit to all Medicare beneficiaries would seem to make sound public health sense. We understand that this broadening will require new legislation, but we encourage CMS to pursue this with Congress.

The PHS Guideline emphasizes that pharmacotherapies, including prescription drugs and FDA-approved over-the-counter (OTC) nicotine replacement therapy (NRT), are integral to any cessation attempt, except in medically contraindicated populations. Use of these pharmacotherapies improves the chances of a successful quit attempt. Yet for many Medicare beneficiaries, the cost of these treatments remains a barrier to their widespread utilization. The Medicare coverage for prescription drugs partially addresses this treatment obstacle. However, OTC NRT, identified as a first-line smoking cessation therapy, may remain out of reach for many on Medicare. The possibility of expanding these benefits to include OTC NRT presents a significant opportunity to further public health.

To the extent that these additional changes would require legislative action, we urge CMS to consult with Congress on PHS-recommended measures that could significantly reduce tobacco-related deaths and disease in the Medicare population. Given the federal role in establishing the services offered by state Medicaid programs, we also encourage CMS and Congress to consider providing federal funding for smoking cessation services to state plans.

The public health benefit of an expanded cessation benefit is clear. Tobacco-related diseases add billions to the costs of Medicare every year, as described in the 2004 Surgeon General's report. Moreover, the National Action Plan for Tobacco Cessation, paying credence to the value of pharmacotherapies in quit attempts, urges coverage of proven treatments in all federally funded healthcare programs. Developed with an eye towards reducing tobacco use by at least 10% in the first year, the plan recommends providing FDA-approved medications, including OTC NRT, via federally funded cessation programs such as a national tobacco quitline and federally funded healthcare programs. With many smokers not taking advantage of proven treatments, "it is essential that effective treatments, including both counseling and medications, be provided" to encourage quit attempts.2/

We encourage the administration and members of Congress to extend the Medicare drug and counseling benefit to all older smokers and to encompass OTC NRT for all smokers, thus helping further to prevent debilitating and expensive diseases.

1/Source 1999-2000 National Health and Nutrition Examination Survey (NHANES)

2/ Fiore MC, Croyle RT, Curry SJ, Cutler CM, Davis RM, Gordon C, Healton C, Koh HK, Orleans CT, Richling D, Satcher D, Seffrin J, Williams C, Williams LN, Keller PA, Baker TB. Preventing 3 million premature deaths and helping 5 million smokers quit: a national action plan for tobacco cessation. American Journal of Public Health. 2004 Feb;94(2):205-10.

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This letter is submitted on behalf of the American Legacy Foundation. Created as a result of the Master Settlement Agreement (MSA) between 46 state attorneys general and the tobacco industry, the American Legacy Foundation is dedicated to building a world where young people reject tobacco and anyone can quit. The foundation develops programs that address the health effects of tobacco use through grants, technical assistance and training, youth activism, strategic partnerships, counter-marketing and grassroots marketing campaigns, public relations, and outreach to populations disproportionately affected by the toll of tobacco use.

While our foundation is perhaps best known for the truth®youth counter marketing campaign, the foundation has also devoted a substantial portion of its time and resources to the development of several successful cessation programs such as: Great Start, the first national media campaign and toll-free quitline number to help pregnant women quit smoking; Circle of Friends: Uniting to be Smoke Free™, a national movement of people joining in support of friends and loved ones who want to quit smoking; “Bob Quits” and “Mary Quits,” reality based smoking cessation ad campaigns that follow the real life quit attempts of two smokers to help educate smokers about the challenges they can expect to encounter when quitting smoking.

In addition to these outreach programs, the foundation has developed a partnership with QuitNet^®, one of the Internet's most visited quit-smoking sites, to provide free online cessation service to individuals attempting to quit smoking. We also operate a Learn to Quit Call Center, which serves metropolitan Washington , DC , including the Maryland and Northern Virginia suburbs. The Call Center provides callers with free smoking cessation information and counseling. Based on these combined experiences, we feel well qualified to comment on the proposal for Medicare to include tobacco use cessation counseling within its service package.

As a threshold matter, we commend the Centers for Medicare and Medicaid Services (CMS) for proposing coverage of tobacco use cessation counseling services under Medicare. We know firsthand that for many smokers, counseling is a vital part of a successful quit attempt. While we believe the CMS proposal is a good start, we believe the proposal could be substantially improved in the following ways.

First, as a matter of principle and sound public health policy, counseling should be available to ANY smoker on Medicare who would like to quit smoking. Indeed, we would go further and suggest — as our colleagues the Partners for Effective Tobacco Policy have in their separate comments — that cessation counseling be available to all federally covered lives. As drafted, the current CMS proposal limits counseling to Medicare recipients who have already been adversely affected by tobacco use or nicotine dependence. We recognize that this limitation is doubtlessly the result of budget constraints. However, by expanding the range of eligibility, CMS would be able to reach tobacco users that may not have developed a chronic disease or illness due to smoking. In so doing, CMS would not only be improving more lives but presumably, saving more dollars in the future.

We also believe the proposal would be improved substantially if it more expressly emphasized the important role of pharmacotherapy. According to U.S. Department of Health and Human Services Clinical Practice Guideline on Treating Tobacco Use and Dependence, the best chance for long-term tobacco use cessation success occurs when counseling is coupled with pharmacotherapy. Indeed, evidence shows that when certain medications are used in combination with counseling, a quitter’s likelihood of success can be doubled or tripled. We urge you to ensure that this important information is shared with all Medicare recipients who participate in cessation counseling.

We also note that while the proposal contemplates coverage of prescription pharmacotherapy, nonprescription drugs like the patch, lozenge and gum are also effective and often more readily available. Cost, however, can be prohibitive for some consumers and therefore, coverage for this unique category of OTC drugs should be considered. And, to ensure that prescription cessation aids are used when appropriate, we would urge that Medicare recipients who participate in cessation counseling be explicitly informed of the benefits available to them under the prescription drug benefit plan.

We also would like to lend our support to the points made in the North American Quitline Consortium’s (NAQC) comment to you regarding the effectiveness of telephonic services versus face-to- face counseling by clinicians. There is extensive literature demonstrating that quitline counseling is as effective as face-to-face counseling provided by clinicians. Like NAQC, we believe that telephonic quitlines are a vehicle for providing increased access to high quality cessation services to many more Medicare beneficiaries than is possible with face-to-face counseling alone.

While it seems clear that clinician based treatment falls within the Medicare benefit categories outlined in the CMS draft decision memo, we concur with NAQC that it would be important to clarify whether the Medicare program can (a) waive any requirement or assumption that cessation counseling services be provided in a face-to-face venue; or (b) allow flexibility in defining services provided “incident to” physician care so that quitlines might be included.

We thank you for the opportunity to comment on this important proposal, and hope we can work together to help Medicare beneficiaries become smoke-free.

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As the Chair and Vice-Chair of the Medicare Coverage Advisory Committee (MCAC), we are pleased to submit these comments in response to the CMS proposal to provide Medicare coverage for tobacco cessation counseling. Please be aware that we are submitting these comments as individuals and not on behalf of MCAC or the institutions where we work. At the outset, we want to make clear that we endorse the CMS proposal to provide Medicare coverage for tobacco cessation counseling. This policy will provide enormous benefit to Medicare beneficiaries in mitigating, reversing, and preventing tobacco-attributable disease. Our specific comments appear below.

QUITLINES SHOULD BE COVERED

CMS has already received a public comment from Linda Bailey on behalf of the North American Quitline Consortium (NAQC), urging that CMS clarify in its final decision that quitline counseling services are covered. We endorse that recommendation for reasons stated in the NAQC letter.

One of us (RMD) works at the Henry Ford Health System (HFHS) in Detroit and oversees a quitline serving members of Health Alliance Plan (a 550,000-member mixed-model HMO) and patients seen by HFHS providers. This quitline, called the Smoking Intervention Program (SIP), utilizes trained counselors (under the supervision of a physician) who help 600-800 patients a year to quit smoking through telephone counseling and pharmacotherapy (i.e., without face-to-face contact). The program's quit rate at six months post-cessation is approximately 25% (conservatively estimated, counting nonrespondents as relapsers); this compares favorably to programs using face-to-face counseling. Most patients prefer the convenience of telephone counseling, and the program is able to operate more efficiently by providing tailored telephone counseling, sending written materials through the mail, referring patients to online resources, and sending orders for pharmacotherapy (either prescription or over-the-counter medications) to the patient's local pharmacy. HAP pays for SIP services and two courses of pharmacotherapy a year (including OTC medications), but SIP could extend its services to Medicare fee-for-service beneficiaries if Medicare will pay for them.

One option that CMS might consider would be to extend coverage to tobacco cessation counseling offered through quitlines that meet certain programmatic criteria. Evaluating quitlines against those criteria could be operationalized through a certification program. For example, a certification program for quitlines could be developed as part of the Disease-Specific Care (DSC) Certification Program (DSC) operated by the Joint Commission on Accreditation of Healthcare Organizations. Indeed, the JCAHO's DSC Certification Program is now developing certification programs for the implantation of Left Ventricular Assist Devices and lung volume reduction surgery, both in response to Medicare coverage decisions.

A TRAINING REQUIREMENT FOR PROVIDERS IS APPROPRIATE

The Draft Decision Memo proposes that "counseling may only be provided by individuals trained in tobacco use cessation counseling." We endorse that restriction. One of us (RMD) co-authored an editorial calling for a national training and certification program for the treatment of tobacco dependence.[1] That editorial, as indicated by its title, explains the need for quality improvement and accountability in the treatment of tobacco dependence. It also points out concerns that have been raised about certification and offers responses to them.

If the training requirement is maintained in the final decision promulgated by CMS, we have no doubt that experts and stakeholders in the tobacco control community will work together and with CMS to develop standards for tobacco cessation training. This training need not be onerous, and online training courses could be developed to meet training requirements. It might be appropriate to develop different levels of training to accommodate brief counseling delivered by a patient's primary care physician and more in-depth counseling delivered by another provider. In fact, the training and certification programs developed in Massachusetts and Arizona offer different levels of instruction and certification.[2][3]

TOBACCO CESSATION COUNSELING SHOULD BE COVERED AS A MENTAL HEALTH SERVICE FOR SMOKERS WHO DON'T OTHERWISE HAVE AN "ADVERSE HEALTH EFFECT ... LINKED TO TOBACCO USE"

The Draft Decision Memo proposes Medicare coverage of tobacco cessation counseling for a "patient with a disease or an adverse health effect that has been found by the U.S. Surgeon General to be linked to tobacco use, or who is taking a therapeutic agent whose metabolism or dosing is affected by tobacco use as based on FDA-approved information." Presumably, the proposal limits coverage in this way because section 1862(a)(1)(A) of the Medicare law states that "no payment may be made ... for any expenses incurred for items or services which ... are not reasonable and necessary for the diagnosis or treatment of illness or injury." Given the long list of diseases and symptoms attributable to tobacco use, a large percentage of seniors who smoke may qualify for Medicare coverage of tobacco cessation counseling even with this restriction in place (although it is not clear to us how "adverse health effect" will be defined will it include symptoms such as cough, or abnormal [but asymptomatic] blood chemistries?). However, many smokers who have not yet developed overt symptoms or illness related to smoking will be denied coverage for cessation counseling. But there IS a way for CMS to mitigate that problem, as described below.

CMS should cover tobacco cessation counseling, even for smokers WITHOUT a smoking-related illness, by considering it as a mental health service. There is strong justification for this, in that there are codes for: a) Tobacco Use Disorder in the section on Mental Disorders in the World Health Organization's International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM)[4]; b) Tobacco Dependence Syndrome in the World Health Organization's Classification of Mental and Behavioral Disorders (ICD-10)[5]; and c) Nicotine Dependence and Nicotine Withdrawal in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)[6]. We presume that Medicare coverage of tobacco cessation counseling as a mental health service would mean that Medicare would pay 50% of the allowable charge for the service, as is the case for mental health services in general. However, for beneficiaries who would not otherwise qualify for Medicare coverage, 50% coverage is better than no coverage at all.

Thus, we urge that CMS adopt a final rule that would provide full coverage for tobacco cessation counseling for the two groups identified in its original proposal (smokers who have a smoking-related condition or who are taking a medication affected by smoking), PLUS coverage of cessation counseling as a mental health service for other smokers who meet ANY of the following definitions: Tobacco Use Disorder (ICD-9), Tobacco Dependence Syndrome (ICD-10), Nicotine Dependence (DSM-IV), or Nicotine Withdrawal (DSM-IV). We would note that the ICD and DSM codes for tobacco dependence and withdrawal are based on an enormous evidence base, as summarized in the Surgeon General's 1988 report on nicotine addiction.[7] This second avenue for coverage of tobacco cessation counseling should extend coverage to a large number of smokers who might otherwise not be covered. For example, a recent study showed that 12.8% of U.S. adults are nicotine dependent using the DSM-IV criteria, or about half of those found in that study to be current cigarette smokers (24.9%).[8] Higher utilization of the benefit would mean higher costs for the Medicare program, of course; however, this additional cost would be more than offset by savings from averted healthcare expenditures, as noted in the Draft Decision Memo under "Costs and cost effectiveness."

SUMMARY

In summary, we endorse the CMS proposal to provide Medicare coverage for tobacco cessation counseling for smokers who have a smoking-related condition or who are taking a medication affected by smoking. We urge CMS to also add coverage of cessation counseling as a mental health service for other smokers who meet ANY of the following definitions Tobacco Use Disorder (ICD-9), Tobacco Dependence Syndrome (ICD-10), Nicotine Dependence (DSM-IV), or Nicotine Withdrawal (DSM-IV). We urge that CMS clarify in its final decision that quitline counseling services are covered under this benefit. We support the requirement that coverage be restricted to providers who are trained in tobacco use cessation counseling. CMS should consider certification of practitioners and quitlines as a vehicle to assure that counseling services are provided based on adequate training and in accordance with evidence-based guidelines.

Thank you for considering these comments.

Sincerely yours,

Ronald M. Davis, MD
Chair, Medicare Coverage Advisory Committee
andDirector, Center for Health Promotion and
Disease Prevention
Henry Ford Health System
One Ford Place, 5C
Detroit, MI 48202-3450

Barbara J. McNeil, MD, PhD
Vice-Chair, Medicare Coverage Advisory Committee
andProfessor and Head, Department of Health Care Policy
Harvard Medical School
180 Longwood Avenue
Boston, MA 02115

REFERENCES

1. Davis RM, Slade J, Ferry LH. Quality improvement and accountability in the treatment of tobacco dependence: the need for a national training and certification programme (editorial). Tobacco Control 2000; 9: 355-358. (http://tc.bmjjournals.com/cgi/content/full/9/4/355)

2. Pbert L, Ockene JK, Ewy BM, et al. Development of a state wide tobacco treatment specialist training and certification programme for Massachusetts. Tobacco Control 2000; 9: 372-381. (http://tc.bmjjournals.com/cgi/content/full/9/4/372)

3. Muramoto M, Connolly T, Strayer LJ, et al. Tobacco cessation skills certification in Arizona: application of a state wide, community based model for diffusion of evidence based practice guidelines. Tobacco Control 2000; 9: 408-414. (http://tc.bmjjournals.com/cgi/content/full/9/4/408)

4. Information on classification of tobacco use in ICD-9 is available on AHRQ's website (http://www.ahrq.gov/clinic/tobacco/codes.htm): Treating Tobacco Use and Dependence: PHS Clinical Practice Guideline
Diagnostic Codes (ICD9-CM)
When clinicians provide treatment to patients dependent upon tobacco, the following diagnostic codes can be used. They can be found in the ICD-9-CM (International Classification of Diseases, 9th Revision, Clinical Modification) coding manual under the section on Mental Disorders (290-319). 305.1 Tobacco Use Disorder
Cases in which tobacco is used to the detriment of a person's health or social functioning or in which there is tobacco dependence. Dependence is included here rather than under drug dependence because tobacco differs from other drugs of dependence in its psychotropic effect.
Tobacco Dependence—See Tobacco Use Disorder above. Excludes: History of tobacco use (V15.82) V15.82 History of Tobacco Use
Excludes: Tobacco dependence (305.1) Billing Codes
A number of billing codes are available in the PHS guideline and may be used for reimbursement of the provision of tobacco dependence treatment. The examples provided fall under the general categories of preventive medicine treatments and psychiatric therapeutic procedures.

5. Tobacco use is classified in ICD-10 as follows: The ICD-10 Classification of Mental and Behavioral Disorders
World Health Organization, Geneva, 1992 F17.2 Tobacco Dependence Syndrome
A cluster of physiological, behavioral, and cognitive phenomena in which the use of tobacco takes on a much higher priority for a given individual than other behaviors that once had greater value. A central descriptive characteristic of the dependence syndrome is the desire (often strong, sometimes overpowering) to take tobacco. There may be evidence that return to substance use after a period of abstinence leads to a more rapid reappearance of other features of the syndrome than occurs with nondependent individuals.
Diagnostic Guidelines
A definite diagnosis of dependence should usually be made only if three or more of the following have been experienced or exhibited at some time during the previous year: (a) a strong desire or sense of compulsion to take tobacco; (b) difficulties in controlling tobacco-taking behavior in terms of its onset, termination, or levels of use; (c) a physiological withdrawal state when tobacco use has ceased or been reduced, as evidenced by: the characteristic withdrawal syndrome for tobacco; or use of the same (or a closely related) substance with the intention of relieving or avoiding withdrawal symptoms; (d) evidence of tolerance, such that increased doses of tobacco are required in order to achieve effects originally produced by lower doses; (e) progressive neglect of alternative pleasures or interests because of tobacco use, increased amount of time necessary to obtain or take the substance or to recover from its effects; (f) persisting with tobacco use despite clear evidence of overtly harmful consequences, such as depressive mood states consequent to periods of heavy substance use, or drug-related impairment of cognitive functioning; efforts should be made to determine that the user was actually, or could be expected to be, aware of the nature and extent of the harm. Narrowing of the personal repertoire of patterns of tobacco use has also been described as a characteristic feature. It is an essential characteristic of the dependence syndrome that either tobacco taking or a desire to take tobacco should be present; the subjective awareness of compulsion to use drugs is most commonly seen during attempts to stop or control substance use.

(Online source: http://www.mentalhealth.com/icd/p22-sb07.html)

6. DSM-IV includes disease codes for nicotine dependence and nicotine withdrawal. The definitions for these codes are:

NICOTINE DEPENDENCE (305.10)

1. Tolerance
2. Withdrawal
3. The substance is often taken in larger amounts or over a longer period than was intended
4. Persistent desire or unsuccessful attempts to cut down or control substance
5. Time spent in activities necessary to obtain / use the substance, and recover from its effects
6. Important social, occupational, or recreational activities given up or reduced because of use of the substance

7. Use is continued despite the knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance

NICOTINE WITHDRAWAL (292.0)

A. Daily use of nicotine for at least several weeks

B. Abrupt cessation of nicotine use, or reduction in the amount of nicotine used, followed within 24 hours by four (or more) of the following signs:

1. Dysphoria or depressed mood
2. Insomnia
3. Irritability, frustration or anger
4. Anxiety
5. Difficulty concentrating
6. Restlessness
7. Decreased heart rate
8. Increased appetite or weight gain

C. The symptoms in "B" cause clinically significant distress or impairment in social, occupational, or other important areas of functioning

D. The symptoms are not due to a general medical condition and are not better accounted for by another mental disorder

(Online source: http://www.mass.gov/dph/bsas/funding/tobacco/criteria.htm)

7. U.S. Department of Health and Human Services. The Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General. Public Health Service, Centers for Disease Control, Office on Smoking and Health, Rockville, Maryland, DHHS Publication No. (CDC) 88-8406, 1988.

8. Grant BF, Hasin DS, Chou P, et al. Nicotine dependence and psychiatric disorders in the United States: Results From the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry 2004;61:1107-1115. (abstract available at http://archpsyc.ama-assn.org/cgi/content/abstract/61/11/1107)

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I am 37 and smoked for 21years. I quit nearly 2 years ago with the help of a web-based program and support group. I have quit smoking many times and even had physician help. I found the web-based program more accessible for me. Help at my fingertips 24hrs per day when I needed it.

I feel that that web-based treatment programs this day and age are even more important that a physician and should be covered by insurances. There are no words to describe what it's been like having help a click away.

I've been quit nearly 2years and am probably saving my insurance many thousands of dollars down the road!

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As a health and human service nonprofit based in Grand Rapids, Michigan, Tobacco Free Partners seeks to reduce the health, economic and emotional burdens that smoking places on the residents of Michigan. Tobacco Free Partners, (TFP) strongly supports the proposal by the Centers for Medicare and Medicaid Services (CMS) to cover tobacco counseling services under Medicare. The proposed coverage of counseling services is critical to addressing the unique and costly needs of this patient population. TFP also believes the proposal should be expanded to include: pharmaceutical treatment in the form of all FDA approved cessation aids; telephonic counseling; the requirement that such services are provided by trained professionals using methods that meet or exceed standards for counseling and interventions and these treatments be offered to all Medicare recipients with tobacco dependence / addiction.

The current lack of coverage for cessation services is well documented. This proposal would offer comprehensive, community-based treatments to this under-served patient population. TFP stands ready to address this urgent healthcare need, and therefore strongly encourages the passage of this vital healthcare benefit.

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CMS is to be commended for attempting to address the need for seniors to access effective tobacco cessation services. Seniors generally have a long history of tobacco use, co-morbidities, and limited resources – including a lack of transportation. For these reasons senior adults deserve to have access to quitlines, one of the most highly effective interventions and most easily accessed cessation services available. The Oklahoma Tobacco Helpline, funded entirely by investment earnings from the tobacco settlement funds placed in our endowment, has been serving senior adults since its inception in August 2003. Senior adults comprise over 11% of the callers to the Helpline. While we do not yet have evaluation data on the success rates of senior adults who access the Oklahoma Tobacco Helpline, the State of Wisconsin’s senior patch program results indicate that seniors are able to quit successfully with the right support. We know from research and practical experience that physicians do not provide cessation “counseling” in the office, but that they will refer their patients to a quitline and many will utilize a fax referral system so that the patient can be reached proactively by the quitline counselors. For many seniors, this option is far superior to a cessation service in which they may have to leave their home and drive or find a ride to those services. This is particularly true for seniors who may be disabled or would be vulnerable if they were to brave the extreme temperatures that plague so many states for so many months of the year. Quitlines overcome these barriers with ease. I urge you to include quitline services in the proposed benefit, and thank you for addressing this important issue for senior adults.

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On behalf of the Tobacco Use Prevention and Control Program, Community Services Section at the Tennessee Department of Health, I would like to thank the Centers for Medicare and Medicaid (CMS) for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling.The intent of the Tobacco Use Prevention and Control Program is to coordinate the tobacco prevention efforts across the state. The goals of the program are to 1) prevent the initiation of tobacco use among young people, 2) promote quitting among all tobacco users; 3) eliminate non-smoker’s exposure to environmental tobacco smoke (ETS) and 4) to identify and eliminate the disparities related to tobacco use. The focus of the program is to provide support to communities to mobilize, build capacity, effect environmental change, and to support non tobacco use. The Tobacco Use Prevention and Control Program supports the December 23, 2004 announcement by the Centers for Medicare and Medicaid (CMS) proposing coverage for tobacco cessation counseling services under Medicare. Smoking is the leading preventable cause of death in the United States. Smoking causes heart disease, stroke, multiple cancers, respiratory diseases, and other costly illnesses. Secondhand smoke causes lung disease and lung cancer. Smoking increases costly complications of pregnancy, such as pre-term delivery and low birth-weight infants. National data sources estimate that over 400, 000 residents of the United States die each year from tobacco-related diseases. Smokers who quit will, on average, live longer and have fewer years living with disability. About 23% of American adults and 28% of teens smoke. More than 70% want to quit, but few succeed without help. Tobacco use treatment doubles quitting success rates. There is great evidence that Tennesseans use tobacco products at a greater rate than the national average and that Tennesseans want to quit smoking. Whether we address young people, second hand smoke issues or our identified populations which are adversely affected by tobacco use, promoting cessation and providing resources which help Tennesseans quit smoking is interwoven into our efforts. Tobacco cessation is interwoven also in the efforts of the other chronic disease prevention efforts within the Tennessee Department of Health. Tobacco cessation is a strategy for the Governor’s and the Commissioner of Health’s new “Better Health: It’s About Time” initiative aimed at encouraging Tennesseans to take charge of their health. One strategy we intend to utilize is the Department of Health and Human Services and Centers for Disease Control and Prevention, National Network of Tobacco Cessation Quitlines, 1-800-QUIT-NOW phone number to publicize and educate the citizens of Tennessee regarding that these proposed Medicare services, if adopted are available from various insurers and health plans. In addition the names and contact phone numbers of insurers and health plans offering tobacco cessation services will be provided to callers. Smoking cessation treatments have been found to be safe and effective. These include counseling and medications, or a combination of both. Face-to-face counseling and interactive telephone counseling are more effective than services that only provide educational or self-help materials. The effectiveness of counseling services increases as their intensity (the number and length of sessions) increases. Smokers are more likely to use telephone counseling than to participate in individual or group counseling sessions. We welcome the CMS proposal to extend beyond the minimal counseling that is currently covered at each evaluation and management (E&M) visit. Medicare proposes to cover 2 cessation attempts per year. Each attempt may include a maximum of four intermediate or intensive sessions with the total annual benefit covering up to 8 sessions in a 12 month intermediate or intensive period. The practitioner and patient have flexibility to choose between intermediate or intensive cessation strategies for each attempt. The Tobacco Use Prevention and Control Program, Community Services Section at the Tennessee Department of Health endorses these proposed changes. Thank you for the opportunity to comment regarding the issue of smoking & tobacco use cessation counseling. I may be contacted via email at vincent.sessoms@state.tn.us or by phone at (615) 741-0686.

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On behalf of the Colorado Department of Public Health and Environment (CDPHE), thank you for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling. We support the coverage of tobacco cessation counseling services under Medicare.

People who quit smoking, regardless of their age, live longer, healthier lives than those who continue to smoke. Counseling - by physicians or by trained counselors over the telephone or in individual or group support settings - is among the most effective means of helping smokers quit.

We encourage CMS to include quitlines in a benefit category. Quitlines are evidence-based and effective (Fiore MC, et al, Treating Tobacco Use and Dependence: Clinical Practice Guideline, 2000) in terms of bringing about abstinence from tobacco use and improving health outcomes. The memorandum did not address the use and effectiveness of quitlines for cessation counseling. The evidence is adequate to conclude that quitlines are “reasonable and necessary.”

In addition, limiting counseling coverage to those who already have a tobacco related illness, prevents many smokers who want to quit from accessing interventions that could prevent them from ever becoming ill. We encourage CMS to expand the coverage to all tobacco users and not limit counseling reimbursement to those with tobacco-related disease.

Thank you again for the opportunity to provide comments on this important issue. Should you have any questions about these comments, please contact Karen DeLeeuw, Director of the State Tobacco Education and Prevention Partnership at 03-692-2515 or karen.deleeuw@state.co.us.

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While I applaud Medicare’s Advantage Plan to cover tobacco cessation I urge you to reconsider the omission of Quitlines and reimbursement of over the counter medications.

Research from the NAQC shows that Quitline services are effective, and the use of a telephone based service eliminates the transportation burden many seniors have in receiving care. Quitlines are accessible to everyone and remove the hurdle of getting to and from an appointment.

Quitlines are evidence based and researched as effective treatment, according to clinical guidelines on tobacco dependence treatment (2000), the CDC community guideline (2000) and the CDC quitline resource guide (2004).

Tobacco Cessation specialists should have a minimum of a Baccalaureate degree in counseling, social work, psychology and be trained in the Public Health Service Clinical Practice Guideline for Treating Tobacco Use and Dependence.

Depending on the patients needs and addiction to nicotine, over the counter medication can be just as effective as prescription medication. I think the value of over the counter medications needs to be re-evaluated and looked at as a more cost-effective treatment as well.

I do not want to diminish the importance of cessation services to Medicare patients. This is a great step in prevention, however I believe failure to include telephone based tobacco cessation services and over the counter drugs is a disservice to Medicare patients.

Donald E. Williamson, MD
State Health Officer
Alabama Department of Public Health

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QuitNet appreciates the opportunity to comment on the proposed decision covering tobacco cessation counseling for Medicare participants.

QuitNet.com Inc. provides web-based comprehensive smoking cessation services and support that are based on the same PHS clinical Practice Guidelines for effective tobacco cessation that Medicare has used to make its landmark proposed coverage decision. (Fiore et al, 2000) In 2004 alone, more than 110,000 individuals registered to quit using QuitNet’s services, including more than 2000 people 65 years or older. The service was created at the Boston University School of Public Health and has been in operation since 1995.

We applaud the decision by Medicare to support smoking cessation counseling for Medicare participants. Our experience supporting the many seniors who have enrolled in QuitNet over the past decade shows that older Americans want to quit, but need significant support to overcome an addiction that many of them have had for more than 50 years.

Our comments focus on two areas:

- we recommend that the benefit language require providers to document that they are implementing the PHS Clinical Guidelines with fidelity;

- we urge Medicare to include coverage for PHS Clinical Guideline based cessation services delivered by telephone and/or web by adopting a policy of nondiscrimination toward delivery modality in both traditional Medicare and Medicare Advantage programs.

We strongly support Medicare’s decision to utilize the PHS Clinical Practice Guidelines as a basis for its coverage decision; however the research upon which these guidelines are based speaks to implementation as well. We urge Medicare to structure the benefit in a way that ensures that the counseling provided adheres to the same high standards. The research which the PHS and Medicare have used to reach their decision was conducted for the most part in carefully controlled trials where clinicians were trained and outcomes systematically evaluated. In real world settings, however, compliance with a full counseling protocol tends to fall off sharply, with less than 20% of physicians actually providing the crucial last two steps of the “Five As” (Assist and Arrange) (Nicholson et al, 2004.) Unfortunately, it is this last component of the intervention that boosts its efficacy beyond what Medicare already covers.

We recommend that to be eligible for Medicare reimbursement, physicians and other covered providers be required to document not just the provision of “counseling,” but compliance with the evidence based practices called for in the Guidelines. Requiring training in cessation counseling is an excellent first step. Management systems, structured protocols and community resources also exist to make cost effective implementation of counseling possible; Medicare rules and reimbursement should make sure they are used.

Essential Elements of the Counseling Benefit

We urge Medicare to use the Guidelines to specify the essential components of effective cessation counseling in its final rule and require that providers document that they have provided these elements in their counseling to be eligible for reimbursement. The reimbursement rate established by Medicare for intensive counseling should be adequate to enable providers to meet these standards in a cost effective manner. The “Five As” provide a convenient mechanism for categorizing the needed components; any covered counseling program should include at a minimum the following elements:

Ask & Advise

- Clear documentation of the provider’s advice to quit should be documented. Assess

- Assessment and documentation of the nature and depth of the patient’s addiction through standard assessment tools; this assessment should recur through the course of a patient’s counseling and serve as the basis for choice of counseling content.

Assist

- Qualified evaluation for pharmaceutical support; assistance in obtaining the medication, whether over the counter or prescription; and continuing assistance and guidance on compliance and proper use of the medication chosen by the provider and patient. Adherence to recommended protocols has proved a major barrier to real world effectiveness of NRT and buproprion; the final rule should specify that counselors must provide patients with an effective and easily accessible medication support program during and between counseling sessions.

- Provision of access to 24 hour inter-session access to professional and social support for the patient online, on the phone, through email or among peer “quitters.”

Arrange

- Referral to a cost effective program to provide relapse prevention support following the conclusion of formal counseling and to insure the high doses of total support that are associated with greater success.

- Follow-up assessment at standardized time-points for the detection of relapse; current standards would suggest time points of 3, 6 and 12 months.

We suggest that practitioners and outpatient settings should be required to have a quality assessment and improvement protocol that tracks their fidelity to the Guidelines, measures outcomes over time and documents steps taken to address identified problems.

Medicare Non-Discrimination Regarding Service Delivery Modality

We understand Medicare’s current intention to provide coverage only for in person professional counseling provided in a clinical setting. Statutory limitations and the very long standing nature of the nicotine addiction of most elders make this a logical starting place.

None the less, we urge Medicare to consider coverage of programs designed to augment such counseling under the “services furnished incident to a physician’s professional service” clause. Limiting all coverage to in-person verbal counseling would effectively remove a physician or health provider’s ability to actively provide inter-session support, relapse prevention, medication compliance support and follow-up services – all of which are recommended elements of an effective cessation service and occur outside the scope of an office visit.

Research shows that additional ways to deliver elements of an effective program are well received by smokers, including telephone and more recently web based systems (Fiore et al, 2000; Cobb et al, 2005; Lenert et al, 2003; Feil et al, 2003). Enabling providers to enroll patients in comprehensive support programs will assist them in making more efficient use of their counseling time and in theory increase ultimate abstinence rates. Web based programs are particularly suited to this task due to their low cost, high consumer acceptance and ability to integrate with Electronic Medical Records (EMR) systems.

Cobb NK, Graham AL, Bock BC, Papanonatos G , Abrams DB. Initial Evaluation of a "Real World" Internet Smoking Cessation System. Tob Control 2005; in press.

Feil EG, Noell J, Lichtenstein E, Boles SM , McKay HG. Evaluation of an Internet-based smoking cessation program: lessons learned from a pilot study. Nicotine Tob Res 2003; 5(2):189-94.

Fiore MC BW, Cohen SJ. Treating tobacco use and dependence: clinical practice guideline. Rockville, MD: US Department of Health and Human Services, Public Health Services; 2000.

Lenert L, Munoz RF, Stoddard J, Delucchi K, Bansod A, Skoczen S , Perez-Stable EJ. Design and pilot evaluation of an internet smoking cessation program. J Am Med Inform Assoc 2003; 10(1):16-20.

Nicholson JM, Hennrikus DJ, Lando HA, McCarty MC , Vessey J. Patient recall versus physician documentation in report of smoking cessation counselling performed in the inpatient setting. Tob Control 2000; 9(4):382-8.

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As an employee of the Anne Penman Laser Therapy Center in Charlotte, North Carolina I have had the pleasure of seeing individuals regain a healthy lifestyle after smoking for many years. Smoking is detrimental to the health of the "smoker" as well as those that spend an ample amount of time with them and non-smoking tax paying individuals. Smoking is definitely a nuisance to society and should therefore be eradicated as quickly as possible. As the new milleniunm progresses, more and more people are receiving medicare benefits. It would be very beneficial to this part of the population to have the chance to quit smoking via a Smoking Cessation program. Medicare recipients do not usually have a large disposable income, and thus can not afford to self pay for a program such as this. If medicare covered this a preventative treatment, a large sum of money would be saved that would have gone toward smoking related illness and disease. Therefore, in the grand scheme of things I am sure that TAXPAYERS would be very happy not to pay for anymore healthcare issues that could have been prevented. Moreover, many more seniors in this country would be happier and healthier.

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I am the coordinator of the Tobacco Quitcenter at Somerset Medical Center, NJ. We are one of 5 partially funded programs in the state of NJ by the Department of Health and Senior Services to conduct face to face smoking cessation counseling.

I applaud your decision to provide coverage for this important service. We provide short-term counseling mean of about 6-7 visits for tobacco users with very high success rates - 41% of patients quit at 6 month follow-up.

I don't know exactly what Medicare's definition is of intermediate vs. intensive counseling. However 3-10 minutes is not intermediate, but only minimal, superficial treatment.

I strongly encourage Medicare to provide coverage for at least 45 minute visits. We do know that there is a dose response relationship - more counseling/more (correct use of medication) equals significantly higher success rates.

Additionally, patients need a menu of options, choices, to empower them to quit. For example, many patients do very well in our short-term counseling quit groups and may prefer group teratment. Group should be covered as well. Groups last 90 minutes. Groups are also more cost effective for Medicare.

Additionally, Medicare should cover all first line FDA approved NRT medications such as OTC medications like lozenges, patches, gum. Cost factors prenvent many patients from making quit attempts.

I'd like to see Medicare take a firm stand, based on the latest science - providing reimbursement for an adequate dose of medicaiton/counseling.

This will undoubly save Medicare money in the long run, open up hope and options for Medicare smokers (extend lives) and send a signal to private insurance companies to stop avoiding reimbursement for treatment.

Regards,
Chris Kotsen, Psy.D.
NJ Licensed Psychologist #3547
Tobacco Dependence Treatment Specialist
Chief of Psychology
Somerset Medical Center

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I have recently become involved with a new and extremely successful method to help people stop smoking. We use a low level laser treatment that is proving to be 50% + effective in helping people stop smoking, chewing, etc. The program has produced very successful results, but unfortunately many potential clients who call for help to quit smoking are prevented therapy because of the cost. I am certain with medicare coverage, most of these people would now be non-smokers, living a healthier and no doubt, longer life.

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We applaud CMS for its decision to reimburse for tobacco dependence counseling services by trained clinicians. This recognizes tobacco dependence as the complex psychosocial, behavioral and addictive disorder that it is. The high prevalence of use and general societal acceptance of tobacco use belies its strongly addictive nature and the complexity of treatment that is often required for successful abstinence. Many older smokers have used tobacco for many years and have attempted many times to stop before but have been unable despite the health and economic consequences confronting them. As consumers they are inundated with mixed messages about herbal products, sham treatments, and unproven therapies such as hypnotism and acupuncture. These patients require the attention of clinicians who can recognize these issues and develop an appropriate treatment plan that successfully addresses them. It requires of the clinician an understanding of the characteristics of nicotine that leads to addiction, the pharmacologic agents available to treat this addiction and the counseling theories to address the behaviors that are associated with its use. We would like to respond to the CMS proposed Coverage Decision Memorandum and request the CMS address several issues in its final decision memorandum:
1. Training requirements for tobacco cessation counselors
2. Coverage for telephonic interventions
3. Proposed codes and intensity of services coverage
4. Coverage of all medications, prescription and over-the-counter

Training Requirements.
We agree with CMS that clinicians with recognized training in behavioral, addictive disorders, pharmacotherapy and relapse prevention receive reimbursement for their interventions. At this time there is a woeful lack of training about tobacco dependence and evidence based treatments for this disease in all professional schools. Our experience in providing educational opportunities for clinicians to learn about tobacco use and dependence over the last 16 years suggests that most physicians and even many master’s degreed counselors have a serious lack of knowledge and experience with effective tobacco intervention. We also recognize that many health care professionals—including physicians, physician assistants, dentists, psychologists, counselors, respiratory therapists, dental hygienists, certified health education specialists, nurses and nurse practitioners, pharmacists—are capable of delivering this effective intervention if provided with sufficient training. The Association for the Treatment of Tobacco Use and Dependence (ATTUD) has been working to develop competencies for tobacco treatment specialists. We strongly urge that these competencies be accepted as the basis for training programs that include instruction and testing in the evidence-based knowledge about tobacco use and dependence and the behavioral counseling skills that facilitate behavioral change. CMS should consider participation in this type of training and certification of competence as a requirement for coverage of this service.

Telephonic Intervention Coverage.
We would request that CMS also consider further the coverage of telephonic interventions. This could include the comprehensive proactive quitline services available, but also telephonic follow-up of initial face-to-face visits. The evidence is accumulating for the efficacy of proactive interventions that are comparable to face-to-face counseling. Telephonic interventions reduce a barrier to access for the many seniors with physical disabilities or those in rural areas with limited access (either distance, lack of public transportation, or trained specialists) to other types of intervention services. This increase in access will allow many more seniors to receive an efficacious intervention and the recommended follow-up visits that have been shown to increase abstinence rates. The telephonic counselors would need to have the same level of training as the face-to-face counselors, assuring quality of the delivered service.

Coding and Service Intensity.
While we recognize CMS’ desire to track coding for these services, we recommend using currently established Current Procedural Terminology (CPT) codes (Health and Behavioral Assessment/Intervention or Evaluation and Management) rather than developing new codes. The current CPT codes appropriately describe smoking cessation services and address both group and individual sessions. We also believe CMS is underestimating the amount of time necessary to appropriately counsel many of its beneficiaries. We recommend an initial session of 45-60 minutes with up to five follow-up sessions for each cessation attempts at approximately 15-30 minutes per session. Many patients with severe tobacco dependence and multiple co-morbidities directly caused by tobacco use or strongly associated with its use require more intensive counseling than those less dependent and no co-morbidities. Having a full range of covered evidence-based treatment options telephonic, brief outpatient, prolonged intensive outpatient and intensive residential treatment will improve the likelihood of successful cessation [Hays; Ebbert]. In the most severely dependent, little counseling can effectively be provided in the suggested timeframes which CMS has outlined for the proposed codes.

Medications.
Finally, we recommend that CMS consider coverage of over-the-counter medications as well as the prescription medications indicated for tobacco cessation. Nicotine gum, nicotine patch and nicotine lozenge remain the basis for many of our pharmacologic treatment plans. These products have been shown to be safe, effective and relatively inexpensive. They are tolerated well by the elderly and have not been shown to have any significant drug-drug interactions—an important concern of elders who tend to use multiple medications. Having a choice of medication options available, including the OTC smoking cessation medications, is crucial to developing the most effective treatment plan for that individual. Coverage of OTC medications by third party payors and many Medicaid programs already exist, control achieved by requiring prescription for coverage.

Thank you for the opportunity to comment on this national coverage decision.

References.
Hays JT, Wolter TD, Eberman KM, Croghan IT, Offord KP, and Hurt RD. Residential (inpatient) treatment compared with outpatient treatment for nicotine dependence. Mayo Clin Proc. 2001 Feb, 76(2) 124-33.

Ebbert JO, Dale LC, Vickers KC, Gauvin TR, Bunge NE, Hurt RD. Residential treatment for smokeless tobacco use: a case series. J Subst Abuse Treat. 2004. June: 26(4):261-7.

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The Smoking Cessation Leadership Center, a national program office of the Robert Wood Johnson Foundation, strongly supports the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare. The decision by CMS will have a significant, positive impact on the health of millions of seniors for many years to come. The proposed coverage decision memorandum did not address adequately the use and effectiveness of quitlines for smoking and tobacco use cessation counseling. Well-designed studies demonstrate that quitlines bring about abstinence, which has been shown to improve health outcomes. Thus, the evidence is adequate to conclude that quitlines are “reasonable and necessary.” Quitlines meet several different benefit categories as defined in the Social Security Act. However, CMS must modify its current interpretation of the “incident to” benefit category to permit broader access to quitlines. Medicare Advantage plans have the right to choose how Medicare-covered services will be provided. CMS should clarify in the final coverage decision for smoking and tobacco cessation services that plans continue to enjoy flexibility regarding choice of provider and the manner in which these services are delivered. The proposed requirement that counseling only be provided by individuals trained in tobacco use cessation counseling is appropriate. NAQC recommends that CMS consider incorporating the Standards of Practice developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD). The proposal to cover 2 cessation attempts per year, with a maximum of four intermediate or intensive sessions per attempt is appropriate.

Thank you for your consideration of these comments.

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I am the Tobacco Education and Prevention Coordinator for Custer County, Colorado. We are a frontier county in the mountains 1 hour away from Canon City or Pueblo where cessation programs are offerred. Nicotine replacement medicines are not available in our county. We have a significant number of residents on Medicare. I am grateful to know Medicare is considering coverage for cessation counseling andalso understands that usually takes more than one attempt to have a successful quit. Hopefully FDA approved nicotine replacement medicines will be included to increase the chances of success.

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The North Carolina Division of Public Health fully supports and applauds CMS' consideration of Medicare coverage of tobacco use cessation counseling. As the leading cause of preventable deaths, responsible for over 400,000 per year, tobacco use exerts an enormous health and economic toll on our society.

The CDC's Guide to Community Preventive Services lists "reducing patient out-of-pocket costs" for cessation treatment as an evidence-based intervention that leads to significant increases in quit rates among tobacco users who want to quit. Medicare coverage of tobacco use cessation counseling would be a vital first step towards implementation of these evidence-based recommendations for our citizens age 65 and older who want to quit using tobacco.

Limiting cessation counseling coverage to those whom already have developed symptoms of a tobacco-related illness, however, prevents many tobacco users who want to quit from accessing interventions that can help them. If the focus of this initiative is prevention of disease, then encouraging and helping ALL tobacco users to quit, especially before they develop disease, is paramount. We encourage CMS to expand coverage to ALL tobacco users and not limit counseling reimbursement to those with tobacco-related disease.

Medicare coverage of tobacco use cessation counseling will not only save lives, but will also set a precedent for all third-party payers for reimbursement of effective, science-based and necessary tobacco cessation interventions. The understanding of the cost-effectiveness of tobacco cessation interventions by CMS will send a message to all insurers that coverage of cessation treatment not only saves lives, but saves dollars as well.

We are fortunate in the world of tobacco control to have excellent, rigorously developed, evidence-based clinical practice guidelines to instruct us as to what is effective in tobacco control (Guide to Clinical Preventive Services, CDC; Treating Tobacco Use and Dependence, DHHS). Congratulations to CMS for working to save lives and improve the quality of life of our older Americans by implementing these guidelines and covering cessation counseling services for tobacco users who want to quit.

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I am writing on behalf of Free & Clear, (F&C) a provider of tobacco treatment services, in response to your request for public comments relating to “Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling”. F&C is one of the largest and oldest providers of telephone-based cessation support in the U.S. We have also been a major contributor to the scientific base of telephone-based cessation, having participated in over half a dozen large clinical trials. We are involved in the operation of eight state-level quitlines, as well as providing phone support for tobacco users for 50 employers and health plans. In addition, we were the service provider for the quitline arm of the recently-concluded Medicare Stop Smoking Program, a large four-cell trial comparing physician intervention with and without nicotine patches, a quitline arm with patches, and a control arm.

F&C applauds the CMS coverage decision memorandum as a major step forward that will positively impact the health of hundreds of thousands of people covered under Medicare. In addition, it will help normalize the provision of coverage for tobacco treatment by private insurers, creating a ripple effect that will potentially benefit tens of millions of tobacco users.

However, the memorandum is silent, both in terms of the evidence review and the coverage recommendations, in regards the role and effectiveness of telephone counseling. A CMS policy that does not carefully think through how to mobilize the potential of telephone counseling to increase the reach and effectiveness of tobacco treatment will be seriously flawed. The original request by the Partnership for Prevention that CMS review coverage for tobacco treatment specifically mentioned the beneficial role of telephone support in their literature review. Additionally, The U.S. Public Health Clinical Practice Guideline and the Guide to Community Preventive Services advises that, “Proactive, or multiple follow up, telephone counseling is recommended as a best practice to help smokers quit”

We recognize that CMS will face some challenges in any effort to include telephone support, including how to fit it into a benefit category, and how do deal with the usual requirement that care be incident to a physician visit. However, we believe that the issue of integration of phone support is uniquely important in tobacco treatment, scientifically justified, and should be considered through:
1) Review of the evidence for stand-alone phone support.
2) Review of issues surrounding who provides the care
3) Review of why requiring physician direct supervision will severely limit the usage of cessation counseling
4) Explicit inclusion of tobacco treatment as part of the new Chronic Care initiatives for any condition impacted by ongoing tobacco use (such as CHF and diabetes)
Because quitlines have proven effective and convenient, the U.S. Public Health Clinical Practice Guideline on treating tobacco use and dependence recommended them as a method to assist smokers in achieving cessation (Fiore et al. 2000). Following advice from the Interagency Committee on Smoking and Health’s Cessation Subcommittee (Fiore et al. 2004), a national network of quitlines was created in November 2004 by the Department of Health and Human Services. This national network can route anyone in the U.S. who calls a single number (1-800-QUITNOW) to his or her local quitline (Tommy Thompson press release 2004). Health plans and employers are increasingly offering similar services, sometimes coordinating closely with the state-level efforts (McAfee 2000, McAfee et al. 2004).

It is also critical to understand that, although the state and national efforts to increase access to telephone tobacco treatment support have been laudable, they are not a substitute for coverage. Without an infusion of orders of magnitude more funding support, these efforts can only meet a small fraction of need. Promotional campaigns in many states are motivating large numbers of smokers to seek advice, assistance, and support from state-funded quitlines. However, funding for these efforts is variable, and demand for services can easily outstrip financing, requiring a decrease in promotional efforts. State health departments must make complex, difficult decisions about how to spend their funds from tobacco settlements and taxes in a manner that achieves desired public health outcomes. With cuts in Federal social spending, more states have been diverting funds from their tobacco settlements and taxes away from tobacco control programs toward balancing their budgets (Schroeder 2002). Quitline programs repeatedly have to defend program content and funding levels. For example, the state of Oregon was forced by budget cuts to suspend quitline operation for seven months in 2003. The governor of the state of Georgia is currently attempting to cut all tobacco control and cessation funding. There is more financial pressure than ever on quitlines to triage services and limit promotion. Thus, relying on state-funded quitlines is not a viable sustainable substitute for reliable healthcare coverage (including Medicare) for phone-based treatment services for seniors.

An established body of evidence shows that relatively inexpensive behavioral and pharmacologic assistance to smokers wanting to quit can double or triple quit rates (Fiore 2000). Four meta-analyses have established telephonic counseling as effective (Lichtenstein et al. 1996, Fiore et al. 2000, Hopkins et al. 2001, Stead et al. 2004). Stead et al. (2004) found a pooled odds ratio of 1.56 for telephone counseling when compared to self-help materials. The efficacy of quitlines has recently been confirmed in the setting of ongoing operations of statewide services (Borland et al. 2001, Zhu et al. 2002, McAlister et al. 2004). In these “real- world” studies, quitlines have been proven effective at promoting tobacco cessation for large numbers of people, including diverse and underserved populations, thus helping to diminish health disparities (CDC 2004, Fiore et al. 2004, Rollins 2002, Smith et al. 2004, Zhu et al. 2000a).

Most importantly, telephone quitlines can help overcome the serious access barriers that prevent most tobacco users from using systematic, high- quality evidence-based assistance. Calling a quitline is convenient, easy, and free to the caller. It can serve as an efficient yet personal way to educate, motivate, and support tobacco users. Tobacco users will use telephone services at a much greater rate than they will use group- counseling programs (McAfee 1998), allowing for greater population impact. This is especially important to the target population of Medicare beneficiaries with smoking-related illnesses, who have mobility problems. Publicity associated with quitlines and awareness of the presence of a quitline appears to create a population impact greater than the quits generated by callers (Ossip-Klein and McIntosh 2003)

A small but growing number of quitlines also assist callers in receiving first-line pharmacotherapeutic smoking cessation aids approved by the Food and Drug Administration for utilization for smoking cessation: NRT (transdermal patch, gum, inhaler, nasal spray, or lozenge) or bupropion. This can include everything from providing decision support and screening, to physician referral or transferring of callers to their health plan, to providing vouchers redeemed at pharmacies, to direct mail- order fulfillment of over-the-counter products. Pharmacotherapeutic quit aids are being widely used, even in the absence of significant insurance coverage (Solberg et al. 2001). Quitlines provide a mechanism to connect pharmacotherapy use and counseling support more easily. McLeod found that telephone counseling with pharmacologic assistance is more effective than either approach alone (Macleod 2003). Swan et.al all found that phone counseling increased the long-term effectiveness of bupropion SR compared to tailored mail (Swan 2003). We have also reviewed our experience with individuals who are over 65 and have used our phone services. Since 1992, we have had 95,790 seniors receive services through our quitline.
Since 2001, it has exceeded 15,000/year. Tobacco users 65 and over are just as successful at quitting tobacco as are those under the age of 65. About 35% of tobacco users in a large sample of nearly 30,000 participants in the Free & Clear five-call program were successfully quit for at least 30 days when assessed one year after enrollment (manuscript in preparation). As the service provider for the telephone service arm of the MSSP study funded by CMS, we found that 84% of those who called chose to enroll in proactive services, and over 40% received three or more calls.

In conclusion, we applaud your decision to make tobacco cessation counseling a covered Medicare benefit for individuals with smoking-related diseases or who are taking medications whose actions are negatively impacted by tobacco use. However, we strongly encourage Medicare to take further action to ensure this decision actually results in significant numbers of eligible beneficiaries quitting tobacco. In order to reach and treat a significant Medicare population with effective counseling, we suggest that Medicare expand its definition of reimbursable providers to include qualified telephone quitlines. We suggest that Medicare ensure that tobacco treatment is delivered by quitline professionals meeting specific standards in tobacco counseling and intervention. The North American Quitline Consortium recommends that CMS consider incorporating the Standards of Practice developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD). These standards were developed for providers of cessation treatment and are based on the core competencies needed to implement the evidence base for effective cessation treatment.

Thank you for your efforts and consideration of this important topic.

REFERENCES

1. Borland R, Segan CJ, Livingston PM, et al. The effectiveness of callback counselling for smoking cessation: a randomized trial. Addiction 2001;96(6):881-889.

2. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Dept. of Health and Human Services, Public Health Service. June, 2000. [http://www.ncbi.nlm.nih.gov/books/bv.fcgi? rid=hstat2.chapter.7644]

3. Fiore MC, Croyle RT, Curry SJ, et al. Preventing 3 million premature deaths and helping 5 million smokers quit: a national action plan for tobacco cessation.[see comment]. Am J Pub Health 2004;94(2):205-210.

4. Hopkins DP, Briss PA, Ricard CJ et al. Reviews of evidence regarding interventions to reduce tobacco use and exposure to environmental tobacco smoke. Am J Prev Med. 2001;20(suppl 2):16- 66.

5. Lichtenstein EL, Glasgow RE, Lando HA, et al. Telephone counseling for smoking cessation: Rationales and meta-analytic review of evidence. Health Edu Res: Theory & Practice 1996;11(2):243- 257.

6. Macleod ZR, Charles MA, Arnaldi VC, et al. Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. Med J Australia 2003;179(7):349-52.

7. McAfee T, Montanari D, Tifft S, et al. Empl Benefits J. Preventing premature death: tobacco treatment services for employees.2004 Mar;29(1):18-23.

8. McAfee TA. Managed care and the state tobacco settlements. Tob Control. 2000;9 Suppl 1:I17.

9. McAfee T, Sofian NS, Wilson J, et al. The role of tobacco intervention in population-based health care: a case study.Am J Prev Med. 1998 Apr;14(3 Suppl):46-52.

10. McAlister AL, Rabius V, Geiger A, et al. Telephone assistance for smoking cessation: one year cost effectiveness estimations. Tob Control 2004;13(1):85-86.

11. Ossip-Klein DJ, McIntosh S. Quitlines in North America: evidence base and applications. Am J Med Scis 2003;326(4):201-205.

12. Rollins G. Smoking quit lines work in clinical trials and actual practice. Report Med Guidelines Outcomes Res 2002;13(21):7-9.

13. Schroeder SA. Conflicting dispatches from the tobacco wars.[comment]. N Engl J Med 2002;347 (14):1106-1109.

14. Smith PM, Cameron R, McDonald PW, et al. Telephone counseling for population-based smoking cessation. Am J Health Behav 28(3):231-241, 2004;- Jun.

15. Solberg LI, Boyle RG, Davidson G, et al. Aids to quitting tobacco use: how important are they outside controlled trials? Prev Med 2001;33 (1):53-58.

16. Stead LF, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev 2001(2):CD002850.

17. Swan GE, McAfee T, Curry SJ et al. Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. Arch Intern Med 2003;163 (19):2337-2344.

18. Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, et al. Evidence of real-world effectiveness of a telephone quitline for smokers. [see comment]. N Engl J Med 2002;347(14):1087- 1093.

19. Zhu SH, Anderson CM, Johnson CE, et al. A centralised telephone service for tobacco cessation: the California experience. Tob Control 2000;9 Suppl 2:II48-II55.

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As a licensed independent clinial social worker and Certified Tobacco Treatment Specialist in Massachusetts, I have the experience and credentials to provide knowledgable comments on this topic. I believe that Medicare coverage for smoking cessation (and cessation for smokeless tobacco as well) is essential for providing quality and cost-effective care for people in this country. I provide individual, phone-based, and group tobacco treatment counseling, and the expense of treatment (counseling and stop-smoking medications) prohibit many people from beginning or continuing the process of quitting and staying quit. We need this coverage.

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I am writing on behalf of the American Mental Health Counselors Association (AMHCA) concerning the recent proposal by the Centers for Medicare and Medicaid Services (CMS) to cover smoking cessation counseling services for certain Medicare beneficiaries. On behalf of AMHCA, I appreciate the opportunity to provide public comment to CMS concerning this important proposal.

AMHCA is the nation's largest professional organization exclusively representing the mental health counseling profession. Our members practice in a variety of settings, including hospitals, community mental health centers, managed behavioral health care organizations, employee assistance plans, substance abuse treatment centers, and private practice. Currently, there are more than 80,000 licensed or certified professional counselors practicing in the United States, including many in rural areas where access to mental health care is often scarce.

Mental health counselors are licensed or certified by 48 states and the District of Columbia to independently provide mental health services, including the diagnosis and treatment of mental and emotional disorders, including those related to substance abuse. In addition, the scope of practice, education, clinical and experiential requirements for mental health counselors as required by state certification and licensure laws are comparable to that for other similarly trained professionals.

Tobacco use is the leading cause of preventable death in the United States, causing more than 440,000 deaths per year. Of these deaths, nearly 300,000 (68 percent) occur among those aged 65 or older. For those in this age group, the average years of potential life lost due to smoking is 9.7 years. There is also strong evidence demonstrating the benefits to smoking cessation, even after thirty or more years of regular smoking. These benefits are profound, even for seniors who have been smoking for many years. This new smoking cessation counseling benefit will go a long way towards reducing the risk of seniors dying prematurely.

AMHCA fully supports efforts by CMS to provide smoking cessation counseling services to Medicare beneficiaries and believes the program, and its beneficiaries, could benefit from expanded coverage for preventive services. However, we believe it is shortsighted of CMS not include Licensed Professional Counselors (LPCs) among those mental health professionals eligible to provide the smoking cessation counseling services. In fact, the scope of practice, education, clinical and experiential requirements for mental health counselors as required by state licensure or certification laws are comparable to that for other professionals who are eligible Medicare providers.

A meta-analysis by Mojica (2004) included data on “counselors’” effectiveness in providing smoking cessation counseling. The study compared the effectiveness of various providers, including physicians, psychologists, counselors, nurses, “unknowns” and “others.” Counselors were ranked third among the list of practitioners who were effective, following psychologists and physicians, and were ranked ahead of nurses, “unknowns”, and “others.” For this reason, CMS should consider the addition of mental health counselors as providers for the program.

Again, thank you for allowing AMHCA to comment on this proposal. Please do not hesitate to contact me at 248-244-0999 should you need additional information about AMHCA or mental health counselors. Beth Powell, AMHCA’s director of public policy and professional issues, is available to you at 703-548-6002, ext. 105.

Sincerely,
James Blundo, LPC, CCMHC
President

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as a smoker who smoked for 30 years a pack a day i know cessation counseling as provided by the internet site, quitnet.com, and the support of its' members, is the only reason i have quit for going on now 10 months. as a nicotene addict i understand that my quit is 'one day at a time,' but i also feel that support/counseling has made me feel that my quit will be permenate. i have tried to quit many times before and failed each of those times simply because i did not have an active long term support/counseling network available for me 24/7/365. this internet site provided that. couple it with my doctor and my therapist and i have made what i believe is my final quit successful. i would recomend that medicare provide to nicotene addicts that want to quit (which is important, the wanting) all the smoking and tobacco use cessation counseling that can be afforded to be given to them.

thank you.

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We at Wellplace have been providing phone-based counseling for several years. We are achieving outcomes above the national norms. This is a result of more intensive phone-based services, averaging 9 or more sessions and 24/7 immediate access to support for handling cravings. I recommend that coverage for phone-based services be extended to a minimum of 9 sessions.

I agree with the need for counselors to have cessation training. There needs to be the development of standardization of training.

I also recommend coverage of NRT as long as the recipient participates in counseling, as evidence indicates NRT without counseling has limited success.

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I am in favor of Medicare coverage for smoking cessation. I direct multiple programs for a community hospital. These programs treat people who suffer the end result of primary and secondary smoking. ( Cardiac, pulmonary and diabetes) Patient outcomes improve when counseling and medications are used concurrently by professionals who are skilled in focused interventions. I know that some interventions of 10 minutes can be very effective.I endorse the tiers as described.

I believe that RT's should be added to the list of professionals who can provide counseling.I am intersted in the deffinition of "training" as mentioned in the proposal and how one achieves this.

I have found telephone support to be very effective, and I wonder if there would be a method of reimbursement for that at any time.

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I am involved in an organization that uses a method that involves laser therapy, guidance and a 24/7 hotline to help people, sick and soon to be sick, stop smoking.

We have had a number of smokers who were desperate to try our therapy to help them stop smoking but they were unable to afford the program; even though the cost is the same or lower than those associated with NRT programs.

Our program is safe, simple, does not require nicotine replacement and is very successful. It is our mission to help as many people as we can break the nicotine habit and we are pleading with your organization to recognize the need and to allow reimbursements for any and all programs that will help smokers break this deadly habit.

We thank you for your consideration in this matter.

Sincerely,

Maria Granito

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The Association of State and Territorial Health Officials (ASTHO) would like to convey its support for the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare.

ASTHO is the national non-profit organization representing the state and territorial public health agencies of the United States, the U.S. territories, and the District of Columbia. ASTHO’s members, the chief health officials of these jurisdictions, are dedicated to formulating and influencing sound public health policy, and to assuring excellence in state-based public health practice. The decision by CMS to provide coverage for cessation counseling services compliments the ongoing efforts of states to reduce the deadly impact of tobacco and improve the public’s health.

Once again, ASTHO supports the decision by CMS to provide coverage to Medicare beneficiaries for cessation counseling services, and appreciates its leadership in taking this first important step to support reductions in tobacco use.

Sincerely,

George E. Hardy, Jr., M.D., M.P.H.
Executive Director

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This is an excellent opportunity to expand the much needed and severly overlooked treatment of tobacco dependance. Having the CMS provide coverage for smoking cessation will in the longterm provide countless savings to our healthcare system. I feel that allowing multiple fields (MD,RT,RN's) perform the treatment will provide the best overall benefit.However it must be ensured that these caregivers have received the appropriate training. There are several excellent programs (UMDNJ in NJ being one) available that I feel are an absolute necessity in being able to provide the needed care to these patients.

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I am trying to register a comment during the Public Comment Period regarding the medicare coverage for smoke cessation therapies. I hope this message will get to the appropriate people. I am involved in a business that uses laser therapy, guidance and 24/7 hotline to assist smokers to break the nicotine habit.The process is easy, safe and successful. We areseeing many clients come through our centers who are now smoke free. Many of our clients who have stopped smoking with us are now business partners running their own centers. We see the need for medicare coverage regardless of the therapy that one may chose. We also see that guidance is the most important component for success. Smokers have trouble going it alone; we believe programs that revolve around guidance and counseling are much more effective.

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On behalf of the North American Quitline Consortium (NAQC), I would like to thank CMS for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling. A quitline is a health service that offers telephone support – information and counseling – for people who want to quit using tobacco.

NAQC is a newly established organization that aims to maximize the access, use and effectiveness of quitlines; provide leadership and a unified voice to promote quitlines; and offer a forum to link those interested in quitline operations. NAQC includes health departments, quitline service providers, research institutes and national organizations in the United States and Canada and enables professionals from these organizations to learn from each other and to improve quitline services.

NAQC strongly supports the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare. The decision by CMS will have a significant, positive impact on the health of millions of seniors for many years to come.

Our comments may be summarized as follows:

• The proposed coverage decision memorandum did not address adequately the use and effectiveness of quitlines for smoking and tobacco use cessation counseling. Well-designed studies demonstrate that quitlines bring about abstinence, which has been shown to improve health outcomes. Thus, the evidence is adequate to conclude that quitlines are “reasonable and necessary.”
• Quitlines meet several different benefit categories as defined in the Social Security Act. However, CMS must modify its current interpretation of the “incident to” benefit category to permit broader access to quitlines.
• Medicare Advantage plans have the right to choose how Medicare-covered services will be provided. CMS should clarify in the final coverage decision for smoking and tobacco cessation services that plans continue to enjoy flexibility regarding choice of provider and the manner in which these services are delivered.
• The proposed requirement that counseling only be provided by individuals trained in tobacco use cessation counseling is appropriate. NAQC recommends that CMS consider incorporating the Standards of Practice developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD).
• The proposal to cover 2 cessation attempts per year, with a maximum of four intermediate or intensive sessions per attempt is appropriate.

In order to clarify the role that quitlines may play in delivering smoking and tobacco use cessation services to Medicare beneficiaries, it is particularly important for CMS to address each of the first three issues explicitly in its final decision memorandum. More detailed comments on these specific issues are provided following a brief overview of quitline services.

Overview of Quitlines

Quitlines are a health service that offers telephone support – information and counseling – for people who want to quit using tobacco. Quitline services are based on several models. Generally, these include proactive or reactive telephone counseling or a mix of the two. Although some tobacco quitlines are part of wider national hotline services covering multiple services, the majority of state quitlines are specific to smoking cessation. In addition to proactive and/or reactive telephone counseling, tobacco quitlines offer a range of services that varies from state to state. These services can include: mailed materials, referrals to other cessation services, taped messages or web programs, the provision of nicotine replacement therapies (NRTs) or assistance in obtaining NRTs, and language- or culturally-appropriate services directed toward specific state populations. A snapshot of the services available in each state is shown on the map at www.NAQuitline.org.

At the North American Conference of Smoking Cessation Quitlines, Lichtenstein noted,

“Telephone counseling represents a major accomplishment for the research community in that an empirically developed and established intervention has been adopted and institutionalized by state government and now provides help to thousands of smokers.”

Although the first quitlines were implemented in the 1970s, the number of states operating quitlines began growing steadily only since California began a tobacco helpline in 1992. By the close of 2004, 38 states had established and are maintaining quitline services. The remaining states and the District of Columbia are in the process of establishing quitlines; currently they receive services from national quitline providers.

The number of smokers who receive intensive counseling from quitlines is limited by the funding that is available to the quitline. In a June 2004 survey conducted by NAQC, we found that the average annual state budget for quitline operations was about $500,000, with a range from $150,000 to over $3 million. Although quitlines currently reach only 1-2% of smokers, it is estimated that with adequate funding, quitlines could reach about 15% of smokers. As a result of limited funding, many state quitlines have established criteria to determine who is eligible for intensive quitline counseling. The most frequent approach to eligibility criteria is to make a single counseling session available to all smokers and to limit more intensive counseling to those who are uninsured and/or those who are ready to quit. In many states, smokers who are Medicare beneficiaries may not be receiving intensive counseling from quitlines due to funding limitations in the state.

Quitlines are “reasonable and necessary.”

We do not believe the proposed coverage decision memorandum adequately addressed the use and effectiveness of quitlines for smoking and tobacco use cessation counseling. Published and ongoing research, both in the United States and abroad, documents the effectiveness of telephone counseling for smoking cessation. Both the efficacy and the effectiveness of quitline counseling have been demonstrated by several meta- analyses as well as numerous individual studies. A meta-analytic review of 13 randomized trials conducted by Lichtenstein et al. found proactive telephone counseling resulted in a sustained increase in cessation for intervention groups as compared to control groups (pooled odds ratios of 1.34 at short-term follow-up – 3-6 months and 1.20 at long-term follow-up – greater than 6 months). A U.S. Public Health Service Clinical Practice Guideline meta-analysis of 58 studies describing psychosocial treatments for cessation demonstrated a 1.2 estimated odds ratio for proactive telephone counseling compared to no intervention. Similarly, a Cochrane Review of 27 trials of telephone counseling for smoking cessation, using rigorous criteria of at least six months abstinence, concluded that proactive telephone counseling is effective and particularly successful when multiple phone contacts take place at the time of a quit attempt. The reviewers noted that counselor calls are “likely to increase the chances of quitting relatively by around 50 percent compared to a minimal intervention such as providing standard self-help materials.”

Evidence for the effectiveness of reactive telephone counseling has not been evaluated in the same rigorous and systematic manner as proactive telephone counseling, in part because randomization is more difficult since it requires that some callers receive less or no assistance. However, several published evaluations have followed and assessed quitline callers’ outcomes. Ossip-Klein et al. investigated the effects of a smokers’ “hotline” combined with self-help materials. More than 1800 smokers were recruited and randomly assigned to self-help materials or self-help materials plus hotline access and followed for 18 months. Results indicated a consistent significant effect for both abstinence and relapse prevention. In another study in Scotland, a cohort of smokers (n=848) who contacted a quitline were followed up by telephone at three weeks, six months and one year. At one year, 23.6% of persons reported abstinence and 88% of persons reported having made positive behavioral changes in their smoking.

Zhu et al. conducted a randomized, controlled trial within the California Smokers’ Helpline using a control group of 1309 callers and a treatment group of 1973 callers. Self-help manuals were provided to all callers. Participants in the treatment group were immediately assigned to a counselor while those in the control group received counseling if they called back and requested it. Counseling was provided for 72.1% of the treatment group and 31.6% of the control group. Smokers were evaluated at 1, 3, 6, and 12 months and abstinence rates were consistently higher in the treatment group. The abstinence rate at 12 months was 23.3% for the treatment groups versus 18.4% for the control group. Likewise, a randomized, controlled trial in Spain indicated that telephone counseling in combination with self-help materials approximately doubled abstinence rates at 12 months. A randomized trial of telephone counseling conducted by the American Cancer Society followed 3500 smokers who called for cessation help. Callers received either mailed self-help materials or self-help materials plus five telephone counseling sessions. Smokers who received the telephone counseling demonstrated higher quit rates at three and six months than the self-help only group.

Research conducted in smokers ages 65 and older demonstrates high quitline utilization rates and significant benefits from the treatment services. In a small trial (177 subjects) with smokers ages 60 and older conducted by Ossip-Klein et al, smokers were randomized to a mailings or a proactive calls condition. All participants had access to the reactive quitline. At 12 months, 50.5% of all subjects had called the reactive quitline at least once, and 25% had spoken with a quitline counselor at least once during a reactive call. These are among the highest utilization rates reported in the literature. More recently, an evaluation of the Wisconsin Senior Patch Program showed that nearly all participants were satisfied with the quitline program and would recommend it to others (94.9% and 97.8%, respectively). Eight months after enrollment in the program, 92% made a serious quit attempt, 44.9% had not used tobacco in the last seven days and 44.6% had not used tobacco in a month or more.

Although the results have not yet been published from CMS’ Medicare Stop Smoking Program, we expect that they will be consistent with the studies described above. This demonstration will compare usual care (smoking cessation information) to one of three different types of smoking cessation services and assess their impact on quit rates. The three options are:

• Reimbursement for provider counseling only
• Reimbursement for provider counseling + FDA-approved prescription or nicotine replacement pharmacotherapy
• A telephone counseling quitline + reimbursement for nicotine replacement therapy.

Early estimates of self-reported quit rates indicate that those assigned to the quitline intervention achieved a quit rate of 32.5%. We urge CMS to review the findings from this key trial, which was designed to help answer the question about the effectiveness of different counseling venues on beneficiaries, before issuing its final decision memo.

All these well-designed studies demonstrate that quitlines bring about abstinence, which has been shown to improve health outcomes. Thus, the evidence is adequate to conclude that quitlines are “reasonable and necessary.”

Benefit categories

Under the draft national coverage decision memorandum, smoking cessation services could be eligible for Medicare coverage when they are provided as:

• physicians services;
• services furnished incident to a physician’s professional service;
• outpatient hospital services;
• rural health clinic and federally qualified health center services;
• services which would be physicians’ services if furnished by a physician and which are performed by a physician assistant, nurse practitioner or clinical nurse specialist;
• qualified psychologist services; or
• clinical social worker services.

Although some quitline services might qualify for coverage on this basis (for example, when provided as part of outpatient hospital, rural health clinic or federally qualified health center services), the majority of quitline services may not satisfy Medicare’s coverage requirements unless changes are included in the final coverage decision. Given the extensive literature demonstrating that quitline counseling is effective, NAQC requests that CMS make the modifications necessary to include these services in its final coverage policy. For example, CMS should waive the requirement that quitline cessation counseling services be provided in a face-to-face encounter with the patient. This waiver would apply only to smoking cessation services provided by professionals meeting specific standards in tobacco counseling and intervention, as recommended below in the section on training requirements.

NAQC also urges CMS to modify the requirements for services provided “incident to” physician care so that quitlines could qualify for coverage on this basis. Frequently, physicians “ask” patients whether they smoke, “advise” them to quit, and “refer” them to quitlines for counseling by trained staff. We believe that the requirement for direct personal supervision could be deemed to be met when a quitline meeting appropriate standards, such as might be established by a state for example, partners with a physician to provide smoking cessation services to the physician’s patients.

We are confident that these suggestions are consistent with Medicare’s approach to financing high quality health services for all seniors while at the same time supportive of the quitline services that Lichtenstein described as “a major accomplishment for the research community in that an empirically developed and established intervention has been adopted and institutionalized by state government and now provides help to thousands of smokers.” The infrastructure for quitlines has been developed and is being maintained by states. Quitlines are a vehicle for providing increased access to high quality cessation services to many more Medicare beneficiaries than is possible with face-to-face counseling alone.

Coverage of quitline services under Medicare managed care

Medicare Advantage plans provide health care to about 13% of beneficiaries. Although these plans are required to follow national coverage determinations and make available to their Medicare enrollees all of the services that are available under traditional Medicare, program rules have long given private plans considerable flexibility in provider selection and benefit delivery. For example, the preamble to the June 29, 2000, final rule implementing changes to the requirements for private plans states that “When a health care service can be Medicare-covered and delivered in more than one way, or by more than one type of practitioner, we continue to recognize a managed care organization's right to choose how services will be provided. These decisions have been left to managed care organizations to allow them to maximize their value purchasing power, and use resulting savings to provide services not covered by the Medicare program.” NAQC urges you, in drafting the final national coverage determination for smoking and tobacco cessation services, to clarify that while plans are required to apply its clinical criteria regarding eligibility for such counseling and any periodicity limits it may specify, they continue to enjoy flexibility regarding choice of provider and the manner in which these services are delivered.

The training requirements for tobacco cessation counseling

Adequate training is a key component in providing high quality and effective cessation counseling. CMS should ensure that tobacco treatment is delivered by professionals meeting specific standards in tobacco counseling and intervention. NAQC recommends that CMS consider incorporating the Standards of Practice developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD). These standards were developed for providers of cessation treatment and are based on the core competencies needed to implement the evidence base for effective cessation treatment.

There are many existing training programs in tobacco cessation counseling. Examples of successful programs include the following:

• Arizona Tobacco Education & Prevention Program’s Training for Healthcare Professionals (http://www.tepp.org/activ/healthcare/index.htm): The state of Arizona offers CME and CEU training to a wide range of health professionals based on the clinical practice guidelines for treating tobacco use and dependence.
• Center for Tobacco Research and Intervention (http://www.cme.uwisc.org): CTRI offers five web-based modules for continuing medical education to help clinicians implement the clinical practice guidelines for treating tobacco use and dependence.
• Mayo School of Continuing Education Nicotine Dependence Seminar (http://www.mayoclinic.org/ndc- rst/conference.html): Mayo Clinic offers in- person 4 day CME and CEU conferences on tobacco use and dependence; 1-3 day CME and CEU customized workshops on issues related to tobacco dependence; CEU workshops on Motivational Interviewing; and a five day intensive competency- based certification program for tobacco treatment specialists.
• University of Massachusetts Medical School (http://www.umassmed.edu/behavmed/tobacco): U Mass offers a program for those interested in earning the designation of "certified tobacco treatment specialist" through an intensive competency-based training program.
• University of Medicine and Dentistry of New Jersey Tobacco Dependence Program (http://www.tobaccoprogram.org): The program offers 1-2 hour seminars, day-long trainings and conferences, along with a 5-Day Tobacco Dependence Treatment Specialist Training.

Length, frequency, and total number of smoking cessation sessions

Medicare proposes to cover 2 cessation attempts per year. Each attempt may include a maximum of four intermediate or intensive sessions, with the total annual benefit covering up to 8 sessions in a 12 month period. The practitioner and patient have flexibility to choose between intermediate or intensive cessation strategies for each attempt. NAQC supports this proposal.

Conclusion

Medicare coverage is contingent upon a determination that a service meets a benefit category, is not specifically excluded from coverage, and the item or service is ‘‘reasonable and necessary.’’ We believe quitlines meet these requirements.

We are confident that coverage of quitlines would be consistent with Medicare’s approach to financing high quality health services for all seniors. Lichtenstein described quitline services as “a major accomplishment for the research community in that an empirically developed and established intervention has been adopted and institutionalized by state government and now provides help to thousands of smokers.” The infrastructure for quitlines has been developed and is being maintained by states. Quitlines are a vehicle for providing increased access to high quality cessation services to many more Medicare beneficiaries than is possible with face-to-face counseling alone.

Thank you, again, for the opportunity to provide comments on this important health care issue. Should you have any questions about NAQC’s comments, please contact me via email at LBAILEY@americanlegacy.org or via telephone at 602-595-3273.

References

Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM: Telephone counseling for smoking cessation: Rationales and meta-analytic review of evidence. Health Education Research 1996, 11:243-257.

² Ossip-Klein DJ, McIntosh S: Quitlines in North America: Evidence base and applications. American Journal of Medical Science 2003, 326:201-205

³ See Ossip-Klein et al (2003) above and Zhu S: Survey of quitlines in North America. Presented at North American Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002

⁴ Lichtenstein E: A review of the efficacy of quitlines. Presented at the North America Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002.

⁵ See: ADHA Smoking Cessation Initiative: Ask, advise, refer. Available at: www.askadviserefer.org/quitlines 2003; Center for Tobacco Cessation: State Quitline Information. Available online: www.ctcinfo.org/upload/quitl_us_chartpdf2003, December; and North American Quitline Consortium map and facts page at www.NAQuitline.org.

⁶ See North American Quitline Consortium map and facts at www.NAQuitline.org.

⁷ McAfee T: Increasing the population impact of quitlines. Presented at the North American Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002.

⁸ See North American Quitline Consortium map and facts at www.NAQuitline.org.

⁹ U.S. Department of Health and Human Services, Interagency Committee on Smoking and Health. A National Action Plan for Tobacco Cessation, Subcommittee on Cessation, Michael C. Fiore, MD, MPH, chair, February 2003 (available at www.ctcinfo.org).

¹⁰ See North American Quitline Consortium map and facts at www.NAQuitline.org.

¹¹ Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM: Telephone counseling for smoking cessation: Rationales and meta-analytic review of evidence. Health Education Research 1996, 11:243-257.

¹² Fiore MC, Bailey WC, Cohen SJ: Treating tobacco use and dependence: Clinical Practice Guideline. Rockville, MD, U.S. Department of Health and Human Services, U.S. Public Health Service, 2000.

¹³ Stead LF, Lancaster T, Perera R: Telephone counseling for smoking cessation. Cochrane Databse Syst Rev 2003:CD002850

¹⁴ See Stead et al (2003) and also Lichtenstein et al (1996) above.

¹⁵ Ossip-Klein DJ, Giovino GA, Megahed N, Black PM, Emont SL, Stiggins J, Shulman E, Moore L: Effects of a smokers’ hotline: Results of a 10-county self-help trial. Journal of Consulting & Clinical Psychology 1991, 59:325-332

¹⁶ Platt S, Tannahill A, Watson J, Fraser E: Effectiveness of antismoking telephone helpfline: Follow up survey. British Medical Journal 1997, 314:1371-1375

¹⁷ Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E: Evidence of real-world effectiveness of a telephone quitline for smokers. New England Journal of Medicine 2002, 347:1087-1093

¹⁸ Miguez MC, Vazquez FL, Becona E: Effectiveness of telephone contact as an adjunct to a self-help program for smoking cessation: A randomized controlled trial in Spanish smokers. Addictive Behaviors 2002, 27:139-144

¹⁹ Rabius V, McAlister AL, Geiger A, Huang P, Todd R: Telephone counseling increases cessation rates among young adult smokers. Health Psychol 2004, 23:539-541

²⁰ Ossip-Klein DJ, Carosella AM, Krusch DJ: Self-help interventions for older smokers. Tobacco Control 1997;6:188-193

²¹ Zbikowski SM, Bush T, Hantz K, Mahoney LD, Garcia-Cabale M, McAfee T: Wisconsin tobacco quit line senior patch program evaluation report. Center for Health Promotion 2003; 32 pp.

²² See Healthy Aging Initiative Demonstration Projects Medicare Stop Smoking Program at http://63.240.208.148/researchers/demos/healthyaging/1b.asp

²³ Lichtenstein E: A review of the efficacy of quitlines. Presented at the North America Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002.

²⁴ See Federal Register, vol. 65, p. 40207 (June 29, 2000.

²⁵ Lichtenstein E: A review of the efficacy of quitlines. Presented at the North America Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002.

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Will you require professional certification for delivery of smoking cessation counseling? Will it be provided by MD's, RN's, PT's, RT's? I would like to suggest and develop a standardized academic course that could be taken by health care professionals (described as "providers" by Medicare) and certified by the nationally recognized academic institution with which I am affiliated. I have directed an Institute for Smoking Cessation and Prevention for 18 years and have taught, conducted research and provided services related to tobacco use. Although I am a Nurse Practitioner on the East coast, I have been collaborating with a PhD nurse on the West coast to develop such a protocol. That is my comment. My question is: who do I contact personally to move this suggestion forward?

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I strongly support the decision by CMS to provide tobacco dependence treatment to Medicare recipients. In addition to providing treatment for patients with tobacco-related illnesses, it would be beneficial to provide treatment to all tobacco users. If tobacco- induced symptoms or adverse health effects have not yet manifested in an individual patient, providing effective treatment to support cessation will reduce the likelihood of that patient developing cancer, heart disease or other serious life threatening disease.

The skills of the individual providers are key to supporting effective treatment. Review of current medical literature indicates that trained providers are more effective than untrained providers in implementing the PHS Guidelines for Treating Tobacco Use And Dependence.

There is a great need for programs to train and certify tobacco cessation providers. Efforts in this regard have been ongoing since 1998 and earlier with a collaboration of the American College of Preventive Medicine (ACPM) and the American Society of Addiction Medicine, as stated by Michael Barry of the ACPM in the testimony submitted to the Cessation Subcommittee Interagency Committee on Smoking and Health, Department of Health and Human Services on October 24, 2002. In his testimony, Dr. Barry referenced the Arizona Certification model.

Efforts have been underway for more than 6 years in Arizona and Massachusetts to establish certification programs. In Arizona, a model has been developed and implemented since 1998 to certify lay people as well as clinicians. Certified providers in Arizona show significant improvement in quality measurement scores.

The Arizona certification model is based on the American Red Cross and the American Heart Association Cardiopulmonary Resuscitation (CPR) and Advanced Cardiac Life Support (ACLS) certification models. The purpose of the certification model is to ensure that persons delivering tobacco cessation services have received education and training consistent with current best practices in tobacco cessation as outlined in the USPHS Guideline, and have demonstrated competency in core skills associated with these practices.

The Arizona model recognizes varied levels of skill and a cross-section of professional roles, is capacity building and sustainable, and is adaptable to diverse populations and cultures. Like the CPR and ACLS models, the Arizona Certification program addresses protocol driven skills, skills demonstration, written tests for proficiency, and mandatory renewal to maintain certification status. Certified individuals function within the context of their professions and/or nationally recognized intensive tobacco treatment clinics as conducted by ALA, ACS or AHA.

I strongly encourage CMS to review certification programs and incorporate a plan for national certification in the proposed Decision (CAG-00241N)

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I believe that ultimately tobacco use cessation counseling will lower overall healthcare costs nationally by providing access to the same types of services that are currently available to those seeking to disengage from other addictive substances. Nicotine is a highly addictive drug, yet we treat it culturally as little more than a habit, and it's costing us dearly.

For years I have worked with and observed people who have conquered their other addictions only to find that tobacco use is their greatest challenge and their least supported. It is one of the most tenaceous addictions we know of. If that support were extended to offer comprehensive treatment that includes treatment of nicotine addiction through counseling, more people would have access to the tools that could save their lives.

Our global environment of interaction has been forever changed by the advent of the internet. This letter is proof of that. Comprehensive online support is far more effective than I would have ever imagined. It is often seemless. Because the global community is involved in most sites, someone is always awake. People looking for support are more likely to "bother" a person online than pick up the phone in the middle of the night because their cravings are so intense they're steps away from relapse.

I think we would be remiss in overlooking online venues as viable and effective support.

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Licensed psychologists should be allowed to provide counseling/psychotherapy sessions and reimbursed appropriately. Psychologists are MEDICARE providers. I have extensive clinical experience with cessation and with this population of elderly with chronic illnesses, they benefit from psychotherapy sessions (45min-75 min) whereby psychologists can utilize varying strategies based upon stages of change and motivational factors, including mind-body interventions, such as clinical hypnosis, behavioral therapies,etc.. We are also familiar with the research on tobacco addiction/dependence. "Cessation counselors" I surmise would not have the training licensed psychologists do who deal with substance abuse,etc. Thanks for consideration.

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I am writing to inquire about the decision to allow smoking cessation counseling in certain cases of people with Medicare coverage.

I am a professional Hypnotherapist that has worked with hundreds of clients that successfully quit smoking. Although I may not be a licensed physician or psychologist, many professionals in these modalities refer clients to me because they are aware of the success in my practice.

What can I do to be included in the coverage of Medicare patients for smoking cessation? Thank you!

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I think since a little bit over 1 in every 5 Americans is a smoker and that there are huge risks involved with this slow, but deadly, killer that we all know and sometimes love as cigarettes, that it would be great to have coverage for smokers to go to their physician and get free counseling on how to stop smoking and also have prescriptions to aid in smoking cessation be covered by med insurance. Web based programs like http://www.quitnet.com have also been extremely helpful in providing guidance during the smoking cessation process. These are non-profit web programs and would benefit greatly if some sort of funding was covered by insurance - the internet is a great forum to reach many people and provide quick and efficient help to something as problematic as attempting to quit smoking.

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The National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, would like to offer its support for the proposed decision put forward by the Centers for Medicare and Medicaid Services to cover multiple sessions of tobacco cessation counseling for eligible smokers who have been diagnosed with a tobacco-related disease, have adverse health effects linked to tobacco use, or who take a therapeutic agent whose metabolism or dosing is affected by tobacco use.

Tobacco use remains the leading preventable cause of death in the United States, resulting in approximately 440,000 preventable deaths each year. Of these deaths, nearly 300,000 (68%) occur among those aged 65 years or older. For those in this age group, the total years of potential life lost due to smoking is 880,000 annually and the average years of potential life lost due to smoking is 9.7 years. In fact, cigarette smoking is responsible for doubling premature mortality rates for America's seniors aged 65 and over. In addition, for every smoking-related death, there are at least another 20 people living with a serious illness caused by smoking, primarily emphysema, chronic bronchitis, and heart disease. Smoking harms nearly every organ in the body, causing many diseases and reduces the health of smokers in general.

Treatment of tobacco-related illness is a major contributor to the $75 billion per year in direct medical costs from smoking. Tobacco cessation treatments are cost-effective; in fact, it has been referred to as the "gold standard" of preventive interventions.

Quitting smoking at any age has immediate as well as long-term benefits, reducing risks for diseases caused by smoking and improving health in general. Within a year of quitting smoking, former smokers reduce their risk of coronary heart disease by half which then continues to decline gradually thereafter. Over 5 years, cessation also reduces the risk of lung cancer by half. Smoking cessation also yields important health benefits to those who already suffer from smoking-related illness. Among persons with diagnosed coronary heart disease, smoking cessation markedly reduces the risk of recurrent heart attack and cardiovascular death. Smoking cessation is also the most important intervention in the management of peripheral artery occlusive disease, as quitting smoking improves exercise tolerance, reduces the risk of amputation, and increases overall survival.

The U.S. Public Health Service cessation guideline, using meta-analysis, showed that counseling services are an important component to the successful treatment of tobacco addiction. Less intensive interventions, such as physicians advising their patients to quit smoking, can produce cessation rates of 5% to 10% per year. More intensive counseling interventions can produce 20% to 25% quit rates in one year.

This service, which CMS proposes to offer, will greatly contribute to the health of our nation. It will also be a vital key in reaching the nation's Healthy People 2010 goals of reducing the rate of cigarette smoking by adults to 12%, increasing smoking cessation attempts by adult smokers to 75%, and increasing insurance coverage of evidence-based treatment for nicotine dependency.

To further improve the health of our nation, it would be beneficial if the coverage of tobacco cessation counseling was extended to all Medicare recipients, including those who have not yet developed a tobacco-related illness so that such illness could be prevented.

Thank you for taking this important step in improving the health of our older adults, and thank you for this opportunity to comment.

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If we had more couseling and coverage for patches, wellbutrim ect. for smoking cessation By insurances (private or medicare) i think we could come to terms with the smoking problems in the U.S. Yes we all have tried more than once, but it is time that we become a smoke free nation. I know a lot of people who will not quit smoking because of the cost.. a lot more than cigs in a lot of the states. I bought my cigarretes at a military base(hubby is retired) which were even cheaper.. something wrong there! It is a tough road for us smokers trying to quit.. even if it cost 2-3 times.. isn't it worth it instead of the health care costs over ten years?

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I was one of the lucky ones, I did not have a serious problem stopping my 50+ year smoking habit that reached 3 packs of 25 cigarettes a day. However I have several friends who have tried various methods to quit smoking, hypnotism, group therapy, chemicals such as Nicoderm CQ (which helped me) plus many other programs. I think we need a serious look into the smoking cesstion counseling in an effort to help those people who simply find it all but impossible to quit. Even special hospitalizations for specified periods of time and covered by Medicare/Medicaid or other Government program.

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This coverage will benefit Medicare patients who have been unable to afford smoking cessation therapy. Please consider allowing respiratory therapists to be among those designated to deliver this therapy. Our pulmonologists rely heavily on our resperatory therapists to provide education and assistance to our patients. We would welcome a smoking cessation certification to be able to provide these services to our Medicare patients and recover at least part of the costs associated with providing smoking cessation therapy.

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Providing the proposed coverage is a big step forward for assisting older smokers facing near-term declines in quality of life. As the co-author of Tobacco Free After 50, I spent many months researching the resiliency of older smokers who quit before deciding to write the book. All evidence I uncovered suggests that the quality of life gains are substantial. The improvement may be no more a newly discovered ability to walk outside to get the mail…but that renewed skill assists the former smoker in their decision to continue to live at home.

The Clinical Practice Guidelines suggest that older smokers be treated as a special population. This population can be aided by age-tailored, self-help materials like the book we have just written. It might be worth testing the efficacy of using the book in conjunction with counseling. I would be happy to supply the number of books necessary for such a test at cost.

Also, I feel it is important to provide “pro-active” outreach to inform this population about the available of support. Our company and the advertising agency Riester Robb are developing such a campaign called the Life After Tobacco ™ advertising campaign and older smoker referral network. The campaign and the network are being tested this Spring 2005 in the state of Louisiana. In the process of developing the outreach network, we have met with many of the organizations that reach older smokers like the Councils on Aging who are not traditionally involved in supporting older smokers. We have found a great willingness and capacity to assist. Regrettably, we have also found a considerable knowledge deficit regarding the availability of existing support services provided by the state.

It is clear to us that much needs to be done if this population of at-risk older smokers are to become informed and motivated to use these new services.

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Action on Smoking & Health wholeheartedly supports the inclusion of smoking cessation coverage for Medicare and Medicaid recipients. In addition to the obvious public health benefits, such programs will have a strongly positive fiscal impact in the long term. Smoking-related health problems cost the U.S. economy well in excess of $100 billion per year, a significant proportion of which is borne by the taxpayers through Medicare and Medicaid. It has been estimated that each pack of cigarettes consumed costs society over $7. The tobacco industry has spent billions to make cigarettes as addictive as possible. It is in society's interest to help people overcome that addiction.

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My original intention was to enter a comment with the recommendation of hypnosis as an effective intervention in smoking cessation in the comment section of the medicare website.- However, my web negotiation skills are as lacking as my patience and I failed miserably at finding the location to express this sentiment. Yet, I believe it is an important recommendation because hypnosis already exists as an effective and cost effective method to maintain a smoke-free life. Even though the most logical as well as the most time and cost efficient thing to do would be for medicare to pay for hypnosis whether or not it is prescribed by a physician, that medicare would pay for this service if prescribed by a physician is certainly a step in the right direction.

About twenty years ago, with the help of a hypnotist, I was able to conquer a three-pack-a- day smoking habit. I vowed that if I ever had the opportunity to learn what this hypnotist was able to do for me, I was going to help others to do the same. That opportunity came about three years ago through study at Infinity Hypnosis Institute in Baton Rouge, Louisiana and certifications through the International Medical and Dental Hypnotherapy Association in Ann Arbor, Michigan. I am a Certified Hypnotherapist with the IMDHA. I am also an attorney and mediator.

Because some of my clients travel three or more hours across the state for sessions - some referred by medical practitioners - I know that it would be very beneficial for them to get reimbursed or subsidized for these sessions. This coverage would also recognize hypnosis for the remarkably powerful tool that it is. Blue Cross and other health insurances already cover some hypnosis applications.

I am living proof that hypnosis works and request that the members of IMDHA be certified as providers of Smoking and Tobacco Cessation Counseling.

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I am a masters level licensed clinical social worker and a certified tobacco addiction specialist. The steps being taken toward helping people quit tobacco are tremendous in recognizing the cost of tobacco addiction and the serious negative impact on human life, the environment, and the economy. Research shows consistently that smoking addiction (and other forms of tobacco addiction) involves psychological, social, physiological, and cultural layers. Consequently, thoughtful consideration regarding the clinical qualifications for receiving smoking cessation reimbursement is important for the consumer AND the taxpayer. Individuals seeking treatment are entitled and have a right to clinicians who can offer comprehensive and professional treatment. Effective counseling skills along with a thorough knowledge of tobacco offers the most efficient form of treatment. I encourage that certification in tobacco addiction be a requirement for reimbursement for mental health clinicians. Respectfully submitted.

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While I congratulate CMS for taking the steps to open tobacco cessation counseling programs for reimbursement, I am very disappointed that the view of "medically necessary cessation" is so narrow and so late.

Were individuals incentivized (or at least financial barriers lowered)to participate in tobacco cessation programs PRIOR to the emergence of "treatable disease" the burden of both financial and emotional costs of chronic disease would be decreased.

Thank you for your attention, and I look forward to the continuing work on this important rule.

Patricia Schafer, Ph.D., RN

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I run a substance treatment center. I work with substance users on a daily basis. 70-80%of alcoholics and other substnaces do smoke and of those who smoke 90% are nicotine dependent. Recent evidence points to nicotine dependence as another addiction if dealt with during attempts to abstain from other substnace it would increase their chances to ramin abstinent form the other substances (alcohol and others)

I endorse your proposal for Medicare coverage of tobacco cessation counseling for smokers who have a smoking-related condition or who are taking a medication affected by smoking and I urge CMS to also add coverage of cessation counseling as a mental health service for other smokers who meet ANY of the following definitions Tobacco Use Disorder (ICD-9), Tobacco Dependence Syndrome (ICD-10), Nicotine Dependence (DSM-IV), or Nicotine Withdrawal (DSM-IV).

I endorse giving the clinician the freedom to do an intensive or moderate course of treatment and allow two episodes per year for smokers who are motivated to quit, also, including pharmacotherapy is essential to achieve this goal. Thank you.

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Ladies and Gentlemen:

I think it is imperative that Medicare provide funding for smoking cessation campaigns. The states were supposed to use the monies from the tobacco settlements to further non-smoking programs and to fund health care benefits for those impacted by disease associated with smoking. To date most of the states have used these funds to expand their own budgets and patients have seen little or no help.

COPD (Chronic Obstructive Pulmonary Disease), for example, is currently the 4th largest fatal disease in the world. It is the only such disease that is growing and it is predicted that in 5 years it will have moved to number 3. Why??? Because COPD is a smoking-related disease in most cases; young people are smoking in record numbers; and current smokers find it difficult if not impossible to quit.

Providing funding to help people quit smoking has to be a win-win situation. It will decrease the funds used to treat people with respiratory problems, high blood pressure, heart disease, stroke and all other smoking-related disease and allow those funds to be used elsewhere.

Thank you for your attention to this matter.

Marva Raines

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Medicare can NOT afford to ignore the cost to the system of treating each smoker who get COPD. A single visit to the specialists office costs over $200. He will prescribe Adair or something like it to be taken daily $100 per month or more FOREVER. He will send you to a Spiromertry testing service $800 per visit, and you will go back at least once a year FOREVER.

These costs are just the beginning and they must be classified as needless expenses for people who quit smoking before they are 35 as a group won't need these things. Which brings raises the question:

If Medicare does indeed reconize smoking cessation as a necessary service for retirees; then should it not also offer seniors who don't smoke or who have quit smoking the option of transering this valuable coverage to a loved one?

That would be a win-win approach to this terribly expensive tobacco addiction problem.

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I believe that hypnotherapy should be considered for this program as well. There is sufficient evidence avaiable that shows hypnotherapy for smoking cessation to be much more effective than medical treatments. (If you do your research you will discover that placebos had a higher efficacy rate than the nicotine patch during double blind studies, and despite this, it was still approved by the AMA even though they were aware of the studies)

I am an active member in good standing with the American Medical and Dental Hypnotherapist Association and they are very strict with their training guidelines. I believe if a hypnotherapist has successfully completed training by either IMDHA or the American Council of Hypnotis Examiners -- both organizations are the best in the field for educational requirements -- then they should be an approved program for smoking cessation by medicare

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I applaud this long overdue proposal to assist smokers over 65 with their cessation attempts. As a Master prepared Health Educator with 30 years as a practicing Respiratory Therapist, I have advocated for this legislation for a very long time. I would hope that we would also consider helping those smokers over 65 who are not yet battling a chronic illness; and like the PA Medicaid system, consideration should be given to covering nicotine replacement therapies and anti-anxiety medications, as they have been shown time and time again to improve the quit rates.

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Tobacco use and addiction is one of the most insidious chronic illnesses in the United States. It prematurely kills nearly a half million people annually and millions live with the debilitating chronic illnesses, such as emphysema and chronic bronchitis, that are caused by smoking.

There are many estimates that millions of dollars could be saved annually if tobacco use were decreased to meet Healthy People 2010 goals of approximately 12% (half of the current smoking rate). Unfortunately, although the majority of smokers who see a physician annually are interested in quitting, physicians have less than one minute to devote to all prevention topics (including mammograms, pap smears, colonoscopy, cholesterol screening, blood pressure screening, etc.). One of the reasons for this lack of time for prevention counseling is the lack of reimbursement.

If the United States is to have any hope of reaching goals for decreasing tobacco use and addiction, reimbursement for smoking and tobacco use cessation counseling must be implemented. This policy change would have long lasting and significant impact on the morbidity and mortality wrought by smoking and tobacco use. Additionally, it will ultimately save millions in lost productivity and care for people suffering and dying from smoking and tobacco use related illnesses. I would give implementation of this policy the highest and most favorable consideration.

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This is needed to help eliminate a major health problem. As a respiratory therapist who conducts monthly smoking cessation programs for the past 8 years I am concerned about qualifications of the individual providing counseling. This should include respipratory therapists who are trained in lung disease. But any healthcare individual must have specific training requirements for providing smoking cessation counseling. This can be in the form of a "certification" through an agency like the American Cancer society, as an example.

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I write to comment on the proposed National Coverage Determination of December 23, 2004, regarding Medicare reimbursement for smoking cessation counseling.

By incorporating the proposed coverage, Medicare would take an important but incomplete first step to provide its recipients with the support they need to stop smoking. However, limiting the benefit to patients who are already suffering from tobacco-related illnesses fails to address a critical health priority: enabling people to stop smoking before they develop tobacco-related illnesses. Providing Medicare reimbursement for smoking cessation counseling among all smokers, regardless of whether they have a tobacco-related illness, would save more lives.

Clinicians often do not raise the issue of smoking with their patients, yet even brief interventions have been demonstrated to significantly increase the quit rate. More than one third of current smokers report never having been asked about their smoking status, yet fifty-seven percent of smokers aged 65 and older report a desire to quit. The proposed Medicare coverage, in addition to its clear health benefits, would also reinforce tobacco use assessment. Reinforcing this practice among clinicians would benefit all patients, whether Medicare beneficiaries or not, which should cause the national quit rate to rise in the long run.

Although the issues of medication coverage are complex, we also strongly advocate for Medicare to ensure coverage of the cost of cessation medications. For example, two 6-week courses of nicotine-replacement therapy, or one 8-week course of bupropion, would be important benefits which are both cost- and life-saving. As you know, medications can double quit rates. In New York City, we provided free nicotine replacement therapy on a time-limited basis to more than 34,000 smokers, and documented a 6-month quit rate of 34%. Rates were even higher among senior citizens, but these individuals were less likely than other smokers in New York City to access our program. Coverage of cessation medications by Medicare would have important health benefits and we hope this can be accomplished in the future.

We thank you for this important step to improve the health of smokers. I hope you will swiftly adopt the next step of providing for smoking cessation counseling for all smokers, regardless of health status, and work to include cessation medications in this important program.

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What a New Year present! We were so pleased to read the proposed Decision Memo on Smoking & Tobacco Use Cessation Counseling (CAG-00241N) released December 23, 2004. The American College of Chest Physician's (ACCP) comprises over 16,500 physicians and allied health professionals, whose everyday practice involves diseases of the chest in the specialties of pulmonology, cardiology, thoracic and cardiovascular surgery, critical care medicine, and anesthesiology. These health care professionals practice in virtually every hospital in the country, and many of the physicians head major departments in these hospitals. As a multidisciplinary society, the ACCP offers broad viewpoints on matters of public health and clinical policy in cardiopulmonary medicine and surgery.

We applaud the Partnership for Prevention for submitting the formal request, that through your staffs due diligence, presented a thoroughly researched proposed Decision Memo that will provide a much-needed benefit to the Medicare beneficiary.

ACCP members care for patients with chronic obstructive pulmonary disease (COPD), consistently ranked one of the top 10 chronic health conditions that severely limit daily activities, and projected to be ranked fifth worldwide by WHO by 2020. COPD annually accounts for approximately 1.5 million emergency department visits and 8 million physician office and hospital outpatient visits. COPD costs our economy an estimated $32.1 billion a year in direct and indirect medical costs. COPD prevalence is highest for those 65 years and older (16.7% among men and 12.6% among women). ACCP members also care for patients with lung cancer, chronic bronchitis, and other lung diseases associated with tobacco use. It makes sense for Medicare to continue to support preventive measures that may limit the incidence of debilitating diseases such as lung cancer, heart disease, emphysema, and stroke.

Attached are copies of the two ACCP smoking cessation kits. First, the ACCP comprehensive Tobacco Cessation Tool Kit that instructs physicians on counseling patients and provides the necessary written tools to reinforce the simple message to not smoke. These materials are based on the June 2000 clinical practice guidelines published by the US Department of Health and Human Services on Treating Tobacco Use and Dependence. In addition, ACCP's CHEST Foundation has developed and distributed a multi-ethnic tobacco education speaker's kit, also an Asian and Indian version that stresses the importance of smoking cessation.

We appreciate the foresight of CMS in allowing two attempts, with four sessions each, at smoking cessation as a covered benefit. We know cessation works through clinical trials that have shown both clinical and cost effectiveness. We also know that an older age is not a barrier to successful quitting because seniors who do try to quit are 50% percent more likely to be successful than all other age groups when they try. This benefit will increase access of seniors, especially those on fixed incomes, to be able to afford the necessary counseling in support of good healthy lifestyle practices.

Medicare Modernization Act's prescription drug coverage has also made available to seniors the FDA-approved prescription cessation aids; for example, nicotine nasal spray, nicotine inhaler, bupropion SR, legend drug, nicotine patches). The accessibility of these pharmacological aids will complement and reinforce the effectiveness of counseling, with the combination of both, nearly double the quit rates.

The most recent AMA CPT meeting in November approved two time-based, 30 minutes, education and training codes, one for individuals, and one for groups, using a standardized curricuJum that will be published in CPT 2006. (Note: these codes are practice expenses only.) We expect that the "time" rule for E/M coding would be, in effect, that if the physician spent more than half of an E/M visit in counseling and coordination of care, that the choice of code would be based on time alone (essentially, the physician would be able to up­code when counseling was provided as part of an E/M).

An example provided with these new generic education and training codes reads:

97XX1 Disease Education Vignette

Typical Patient: A 35 year-old woman with a symptomatic established illness or disease, e.g. diabetes or asthma, or the desire to delay disease comorbidities, e.g. cardiovascular co-morbidities, is referred by a physician to a qualified, non-physician health care professional for education/training, e.g. RD or RN.

CMS is also able to develop new HCPCS "G" codes similar to the new codes for pulmonary rehabilitation or the previous codes for diabetes education.

We anticipate that the final National Coverage Decision (NCD) for smoking cessation counseling will be considered a "change in law or regulations" when CMS determines the Sustainable Growth Rate so that the costs incurred are excluded from the pool of physician expenditures.

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I have been a Respiratory Care Practitioner for 24 years and a member of the American Association of Respiratory Caresince 1991. I am currently employed as a Respiratory Therapist health coach and assist my clients in smoking cessation education as well as Asthma and COPD education. These clients that I serve are among the fortunate to have private or employer sponsored health care coverage and receive information, councilling and support without concerns of cost. There are however many individuals however who may not have access to this benefit. A nationally covered beneift would in my opinion greatly expand the outreach efforts to those who really want to stop smoking. The numbers of people I have treated or coached over the years who have been affected by cigarette smoking is staggering. It's time for Medicare and Medicaid to step up to the plate to help those who want to help themselves.
Thank you.
J.O'Farrell, RRT, BS

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I work as a Tobacco Prevention Nurse Consultant for the State of Pennsylvania and therefore look at research daily regarding tobacco issues. Several studies support the provision of Zyban and Nicotine Replacement Therapies (NRT)together as being more effective than NRT alone.

See New England Journal of Medicine article, "A Controlled Trial of Sustained-Release Bupropion, A Nicotie Patch, or Both for Smoking Cessation" (Vol.340,Number 9, 1999) by Jorenby, Douglas E. etal.

Tobacco use is a serious addiction and most other drug addictions cannot be sufficiently treated by only 4 counseling sessions.

Thank you for your consideration and that you are looking into this very important public health issue.

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I would like to request consideration for reimbursement for smoking cessation professionals other than physicians, particularily Respiratory Therapist who possess specialized training or certification in Nicotine Dependence Treatment. I have been working in this speciality since 1997 after receiving training at the Mayo Clinic. I have also received training in the TEG and TAP program and currently preparing for my certification as Tobacco Treatment Specialist with NAADAC and the University of Florida. I see patients at the bedside on a daily basisi and also offer an outpatient program. Both programs foloow the Clinical Practice Guidelines For Tobacco Use and Dependence. We have a pateint database to track outcomes. I would also like to request that reimbursement be provided for the use of spit tobacco products as the use of these products pose similar risks as smoking. Respectively submitted for your consideration.

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I am very happy to see that CMS has taken this issue into consideration. I am a pharmacist who works in a Family Practice Center. We see the negative effects of tobacco use on a daily basis. Not only do I believe that tobacco use cessation counseling should be covered to those already ill, but it should be offered to all beneficiaries. Prevention is key to good health and less expenditures of health care dollars. I would argue that the pharmacotherapy should also be a covered benefit, and that pharmacists be included in those offering such counseling services. I work directly for a group of family physicians, and they refer patients directly to me to be seen for smoking cessation therapy. Not only have I received certification training in smoking cessation, but the residency director of our clinic has repeatedly requested that I help in the training of our medical residents.

CMS is offering a benefit to its patients that could have lasting benefits to US citizens. Doing it the right way will ensure its success.

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I applaud your decision to provide coverage for tobacco use cessation. I have seen the effects of tobacco use on the patients I have cared for as a respiratory therapist for over thirty years. I strongly recommend that you include registered respiratory therapists in the coverage of practitioners wno provide cessation counseling. We are in the front lines of patient care and have the background knowledge of physiology to help patients understand the effects of tobacco use on their bodies. We are frequently called upon by staff members throughout the hospital to recommend pharmacologic aids for patients suffering nicotine withdrawal. We have provided reference information to staff physicians about treatment medications. Tobacco cessation would result in a decrease in healtcare needed by the using population as well as improve the life of persons who quit using tobacco. There are excellent training programs for anyone who wants to provide this service. It would also be helpful to patients who want to quit to have coverage for pharmacologic aids for cessation.Thank you for considering the respiratory therapist population in your planning.
Karen Sroufe, RRT, RPFT
Pulmonary Rehab Clinical Specialist

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Reimbursement of services should be provided to those who are competent to provide the service. There are presently many levels of training being provided to individuals, some of which are not evidence based or not based on the "Treating Tobacco Use and Dependence" guideline, where over 6000 articles were reviewed when being developed. Still some have received only basic training, such as the "5A's" and "5R's," not at the level that a Tobacco Treatment Specialist would or should have.

I personally think that it is very important that a set of standard core compentencies, such as those in the final stages of development by the Association for the Treatment of Tobacco Use and Dependence (ATTUD), be utilized when measuring a Tobacco Treatment Specialist compentency for providing treatment.

Reimbursement of services should not be based solely on the title (MD,RRT,RN,LSW)of the individual delivering the treatment, but rather the level of training received by and the compentency of the individual providing that treatment.

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I strongly support Medicare's move to prevention. It is LONG over due. I encourge you to reimburse for Master's level and BA level with Master's supervision of service providers who specialize in health education and prevention. This is the future of our health care industry. It is not in the reimbursement of MD level specialists. Behavior change is key to prevention and MDs and Ph.Ds are the most ill trained and poorly prepared to do it. They are ill qualified and have no training or education in health education or prevention. You waste too much money through restrictive policies that discount the skills of thousands of professionals trained in behavioral methods such as remotivation therapy. Persons with MAs, MSs, and MSWs have much to contribute to our nation's health. Don't waste your money on high priced MD and Ph.Ds who rip you off and give little in return. Let persons with valid and meaningful training at the Masters level have a chance to serve the elderly. This is very important in rural areas and inner city areas with few health professionals. NPs are fine but again they have no behavioral training. You will get a bigger bang for your buck at the Masters level. Ph.Ds trained in research have little to offer you.

Sincerely, a self serving Masters level trained person.

John Bierma

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I am a respiratory therapist, and am also a nurse. Please consider allowing respiratory therapists the ability to provide smoking cessation counseling. Respiratory therapists are lung health experts. The knowledge we posssess in this arena is matched only by pulmonologists. Our education and real-life experiences are unmatched by an other health care worker, including nurses and human services counselors.Thank you for you consideration and interest in this important health matter. Tobacco use and the affiliated diseases caused by its use represents a huge expenditure of both money and human resources. COPD, caused most often by cigarette smoking is the fifth leading cause of death. Heart disease, cancer and stroke, also consequences of tobacco use, help round out the top five causes of death. many of these deaths are preventable if people would only quit smoking! Arm these folks with the best they can get, please allow respiratory therapists the ability to share their expertise.
Thank you-
Amy Chaves, M.Ed., RRT, LPN, CHES

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Please include respiratory therapists as smoking cessation counselors. We have been providing this service since the early 90's with great success. Special training or certification should be required. Mayo Clinic has an excellent training program that our staff completed. We currently offer 1 inpatient session with evaluation, identification of triggers and treatment plan. We offer a more in-depth outpatient 3 session program that involves complete evaluation, methods to quit, identification of triggers, behavior modification, stress management, development of an action plan and follow-up plan to prevent relapse.

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I am an internist at a major academic medical center. I've been doing tobacco cessation actively in my practices since before there were any pharmacotherapies. Since 1997 I've been the physician for a tobacco cessation clinic at our medical center that serves mainly Medicaid patients with many co-morbid medical and psychiatric conditions. I do almost all the teaching in tobacco cessation and pharmacotherapies to the students, housestaff and attendings at our medical center.

It is unclear from the proposal exactly what constitutes a "certified" tobacco cessation specialist. Am I qualified as the local expert at a major academic medical center? Are all physicians "certified" automatically? Will there be standardized certification courses required to qualify? In general, I feel that no one should "grandfather-in" just because they are a physician, psychotherapist, certified addiction councelor, or whatever. These other titles are necessary pre-requisites, but the issues and knowledge required for quality tobacco cessation assistance are specific enough that it warrants additional specific training. I can tell you that most physicians know little about tobacco cessation and never address it with patients beyond advise to quit. Most don't know how to use or write a prescription for nicotine polacrilex. There should, however, be a mechanism to grandfather-in for those individuals who are already very experienced in tobacco cessation.

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Please include Respiratory Therapist as Medicare providers of smoking cessation programs.

Respiratory Therapist’s routinely provide testing related to lung health, and offer patient education to improve lung health.

“Airflow assessment: The newly developed National Lung Health Education Program, sponsored by government and professional medical organizations, was designed to identify early stages of airflow obstruction (ie, COPD and related disorders) in smokers. Spirometry of airflow and air volume (ie, forced expiratory volume in 1 sec, forced vital capacity) can indicate whether smokers already have impaired airflow, and this information may be a potent motivator for smoking cessation. Tracking airflow over time in a patient who continues smoking or stops smoking is a powerful indicator of prognosis. A strong public health message is being prepared to urge all smokers to "test your lungs and know your numbers." The aim is to help smokers at greatest risk (ie, those beginning to lose airflow).

Exhaled carbon monoxide testing, available through some hospital respiratory therapy departments, may convince the smoker of the poisonous effects of inhaling cigarette or cigar smoke. This test should be performed on admission because the decay curve for carbon monoxide is rapid. Many respiratory therapy departments offer smoking cessation advice and instruction.” http://www.merck.com/mrkshared/mmanual/section21/chapter290/290b.jsp

Respiratory Therapist are active and effective in promoting smoking cessation. This expertise is recognized by many public health associations including: NHLBI, AHA, ALA, and the ACS .“The AARC is an active member of the Coalition for TobaccoFree Kids. Other key members of this Coalition include the American Heart Association, the American Lung Association, and the American Cancer Society. Congressional and regulatory efforts…” (http://www.aarc.org/advocacy/state/smoking_treatment.html) Pharmacists can provide smoking cessation education, but frequently have other priorities that limit patient counseling on smoking cessation. Smokers may feel pharmacists are “selling” cessation products.A recent evaluation of smoking cessation practices by pharmacists disclosed that pharmacists do not routinely identify smokers, engage smokers in smoking cessation-related activities, or document smoking cessation patient information and outcomes. (CDC. Tobacco use - United States, 1900-1999. MMWR Morb Mortal Wkly Rep. 1999;48:986-993.)

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I am a family physician who takes care of indigent patients, many of whom rely on Medicare as their only payor. I have often been astonished and outraged that Medicare is willing to spend taxpayer dollars on cardiac catheterizations and coronary artery bypass grafts and hospitalizations for COPD exacerbations, but unwilling to pay for smoking cessation. Smoking cessation saves lives and saves money. Medicare should be paying for smoking cessation aids, for both medical and financial reasons.

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The Surgeon General has reported that "smoking is the single most preventable cause of premature death in the United States." Getting a patient to quit smoking has a greater impact on health than most of the disease I treat. Yet if I take the time to do it (which I usually do), I do it without compensation. It is time to align compensation with the areas that physicians have the greatest impact. It is time to reimburse health care providers for smoking and tobacco use cessation counseling.

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The support of tobacco cessation initiatives by the CMS would be invaluable to those affected, physicians and the public in general. Tobacco not only places people at risk for many diseases, it also advances aging, and endangers the health of the children of smokers. Even though physician counseling has been shown to be effective, there is never enough time to do thorough counseling with patients- and patients are often interested in more. Helping more people quit will help all of us in that we will be able to create a healthier America, reduce the healthcare costs for this country and create more physician time to care for those who cannot access medical care right now.

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As a family physician who treats too many patients after they suffer complications of long- term tobacco use, I find it imperative to refer my patients to smoking cessation programs. They are much more likely to succeed if they participate in formal counseling. Additionally, the public health will benefit significantly from decreased tobacco use we will not only decrease morbidity from associated conditions, but also decrease health care costs by preventing chronic illnesses. I am strongly in favor of this proposal.

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I am a Family Medicine Physician, Board Certified in the Specialty. I believe that if such a policy is adopted that Family Medicine Physicians should be eligible for reimbursement without any additional certification. In Medical school and in Family Medicine Residency the physician learns the impacts of smoking as well as the techniques to counsel people to help them stop smoking. We are familiar with the pharmacuetical adjuncts to such care. We frequently have the oportunity to attend Continuing Medical Education on the subject. We also have the experience to see the consequences of such use and relate those experiences to our patients. Many of us are involved in the national "Tar Wars Program" for tobacco prevention in school age children sponsored by our national American Accademy of Family Physicians. We are well qualitied to manage tobacco cessation.

Thank you for your attention to this matter.
Gary Tubbs, MD.

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The North Country Healthy Heart Network, Inc. (Heart Network) is a NYS Tobacco Control funded Tobacco Cessation Center serving Northern New York. Based on our experience over the past 3.5 years providing services to low income people and their health care providers, it is our opinion that Medicare reimbursement for intermediate and intensive tobacco cessation counseling will accomplish the following four important objectives.

1) Increase identification and treatment of tobacco users. Many doctors with competing, reimbursable demands on limited time per patient, have not been able to devote the appropriate level of intervention with their patients that smoke. Medicare will now remove the monetary barrier for an important segment of smokers and move tobacco identification and intervention into a higher priority level.

2) Improved competencies. Increase desire by clinicians for training on evidence based treatment for tobacco use - Clinical Practice Guideline: Treating Tobacco Use and Dependence.

3) Increase quit attempts. Tobacco users will have access to timely, treatment provided by their healthcare provider or other appropriately trained personnel.

4) Decrease confusion. Right now in NYS, Medicaid covers the cost of most FDA approved pharmacotherapy. Without reimbursement for counseling, low income seniors may be provided prescriptions for helpful medications, without a corresponding plan to quit or clear understanding of how to use the medication. Coverage for counseling and medication will fortify the smoker with a treatment plan that fits their needs and give them the best shot for success.

5)Increase compliance JCAHO Core Measures: Medicare reimbursement for tobacco counseling will increase visibilty of the importance of tobacco identification and intervention. It is our expectation that hospital compliance of identifying smoking patients with pneumonia, heart failure and heart attack, and advising/ counseling them to quit will increase as a result too.

The North Country Healthy Heart Network urges the Centers for Medicare and Medicaid Services to:
1) broaden the base of tobacco users to include all Medicare beneficiaries;
2) speed up the time period and expand Medicare coverage of all FDA approved medicine for tobacco cessation;
3) not limit "qualitifed tobacco cessation counselors" to specific health care professions.

The North Country Healthy Heart Network, Inc. lauds Medicare's leadership on this very important issue. We believe your actions will stimulate others - Medicaid and other insurance carriers to follow.

Thank you for the opportunity to comment on this proposed policy.

Respectfully and thankfully,
Margot Gold
Executive Director

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As an advanced practice Registered Nurse functioning in a pre-surgical evaluation area , I daily come in contact with clients whose pre-operative and post-operative health status is dramatically effected by tobacco abuse. I often counsel my clients to seek assistance in quitting smoking. They often comment that they cannot afford to seek medical help because of the cost involved and the fear of failure and then having again to go through the same process at their own expense. Cigarettes like alcohol are an addictive drug but yet, healthcare insurers do not have the same imperatives in assisting clients to quit. Some who have been alcohol abusers have found it easier to stop drinking. There is much public and medical support for the alcohol abuser. Mental health issues receive direct stated support. Any drug abuse is not only a physical dependence but an emotional and psychological dependence as well. We tell people they must stop smoking but not offer them viable means or methods. Smoking causes severe, system wide and long lasting destruction to the human body. I strongly support the request and recommendation for medicare and medicaid coverage for smoking cessation. I also believe that coverage should also be extended as preventative coverage to assist health centers and other medical professionals in deterring teens and others from taking that initial cigarette..

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I strongly support Medicare's initiative to reimburse smoking cessation services for beneficiaries. Funding for most local state programs has diminished, causing many programs to discontinue operations. Working in an inner city clinic with many COPD patients, it would save not only our institution a great deal of money, but the national costs of treating patients with COPD would decrease. COPD is the only disease state for which mortality has been on the rise over the past 40 years, and it is currently the #4 cause of death in this country. Smoking cessation is the only interventions, including medications, that can decrease the progression of COPD. I applaud CMS for considering this initiative.

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As a physician from "Tobacco Country" I urge you to support Medicare coverage for smoking cessation efforts. Tobacco use adversely affects nearly all major health problems in both children and adults, and quitting is tremendously difficult.

I believe the costs incurred in covering smoking cessation will represent a significant long-term monetary savings over the cost of treating smoking-related illnesses in smokers and those around them. In addition, cessation will decrease the suffering of those who struggle with this addiction and its resultant diseases in themselves and their loved ones.

Thank you for the opportunity to comment on this issue.

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Research has shown that stopping smoking results in improvement in health status at any age, including in those persons aged 65 and over. Those born between 1900 and 1948, who are now aged 50 and over had smoking rates among the highest of any U.S. generation (2001 THE CENTER FOR SOCIAL GERONTOLOGY, ANN ARBOR, MI). Since one in three smokers die prematurely in the U.S., losing an average of 12 to 15 years of life, we can expect an elimination of the retirement years for most of these people. I applaud any proposal will cover cessation counseling for Medicare recipients. However, studies have shown that if you combine nicotine replacement therapy with (counseling) more specifically, a behavior modification type program, the person's chance for a successful quit attempt doubles! Free NRT must be offered in the proposal. Counseling and a person's willpower alone has not proven to be successful. Besides, as America ages, it is more cost effective to spend $ on nicotine replacement products than it is to care for so many people who will die of a smoking related illness.

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Registered respiratory therapists must be considered as providers of smoking cessation therapy. We receive the most education geared strictly toward the pulmonary system and it's health than do nurses or pharmacists. The home care therapists would be a fantastic fit for counseling of the patients. These patients have a tremendous respect for their therapists who have provided them with information regarding disease processes, how it affects their life/lifestyle, what to expect as the disease progresses as far as equipment needs and so forth. The therapist is also in the home quite frequently and sees firsthand the support system these patients really have. Home care RT's are also quite familiar with the psychological impact that these disease processes have on patients. Pulmonary Reahbilitaion therapists would be another great fit as smoking cessation counselors. They could implement the program into the rehabilitation program. It seems ridiculous to overlook the profession that day to day has some of the most "hands on" contact with patients who could benefit from this service. It is just as important to provide this service to people who have not yet become "patients". Leave that to the counselors and pharmacists. Let the respiratory specialists handle the patients. This in turn will help drive down Medicare costs for hospitalizations as well as DME and mediations. Obviously, anyone providing the counseling must go through the appropriate certification that is backed by Medicare.

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I commend the great efforts of those that drafted this fiscally sound and potentially life-saving proposal. It is certainly a step in the right direction in reducing tobacco-related morbidity and mortality as well as reducing the costs associated with medical treatment of tobacco-related disease.

I would, however, like to urge that coverage be expanded to ALL tobacco-using Medicare recipients. By the time a patient has developed a tobacco-related illness or disease, their quality of life has already been negatively affected, and the medical costs associated with the tobacco-related illness have already increased. By helping these individuals to quit smoking PRIOR to the onset of disease, these negative repercussions could be prevented.

Additionally, I would like to strongly urge that FDA-approved NRT medications also be covered by this policy. As noted in the draft decision memo regarding the proposed policy under the section entitled Evidence, “Nicotine replacement therapy was found to be more effective than control in smoking cessation, with an odds ratio of 1.72.” With such evidence to support the effectiveness of NRT, it only makes sense to include it as a part of comprehensive tobacco addiction treatment.

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Effective tailored online and print-based smoking cessation interventions (that take a counseling approach) need to be included in the the program. Programs like HealthMedia's Breathe (R) are proven to be as effective as personal or telephone counseling, are readily available and convenient to smokers, are preferred by many smokers over personal counseling or telecounseling, and can be delivered for a small fraction of the cost of other types of counseling.

In a trial with Kaiser Permanente, HealthMedia Breathe(R) achieved smoking quit rates of 31.3% at 180 days and 24.5% at 360 days, determined according to an Intent-To-Treat analysis.

To reach the greatest number of smokers at the lowest possible cost, all types of counseling appproaches need to be included in the National Coverage Policy.

Thank you for the opportunity to comment.

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AACP commends your decision to cover smoking and tobacco use cessation counseling. We would encourage you to explicitly include pharmacists as eligible to be paid for providing this service. Contemporary pharmacy graduates are competent to deliver this type of counseling. Research supported by NIH and CDC is undertaken by faculty researchers to improve smoking cessation counseling. Pharmacists are the most readily accesible of health care professionals and regular contact with the patient is important in changing behavior. If you need further information on how pharmacists help patients stop smoking please don't hesitate to contact us. Thank you for your consideration of our request.

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I have been involved in Respiratory Care for over 20 years in various aspects. My specialty lies in pulmonary functions and smoking cessation. I fully support payment of tobacco cessation services by Medicare. I further would recommend that those providing services,no matter what their discipline, have specialized training through the American Lung Association, American Cancer Society, or at a program sponsored by an accredited institution such as the Mayo Clinic's Nicotine Dependency Center. I have held various formats for tobacco cessation classes, and would like to see at minimum an 8 week group program, and possibly 3-4 private sessions available to the Medicare population. Financial assistance with nicotine replacement products should also be included, especially the first 12 weeks after starting therapy. During our program, we also provide spirometry screening and carbon monoxide breath checks. This benefit will definitely contribute to increasing the physical health of this population and ultimately decreasing the financial burden on the service.

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I applaud your efforts to offer coverage for cessation counseling and pharmacotherapy for nicotine addicition. I am masters level health education specialist with specialized training to identify and treat nicotine dependence among adults. I currently work in a vascular surgical practice where I work under the medical direction of a vascular surgeon. The average age of my clients is 62. The majority of our patients recieve their health care coverage through Medicare. My success rate after 3 yrs of operation (including all patients and treatment failures) is 41%. I see very few Medicare patients in our program as it is fee for service due to the fact that no reimbursement is available. We are very low cost at $225 for a full year's access to counselor. This could be a very big deal for our patients. Ours is a phone based program with time allotted at clinic visits for follow-up. We are located in Indiana and many of our patients come from rural areas where access to licensed health care providers is limited and few are nicotine dependence specialist. So, please consider covering phone counseling. I echo sentiments that qualified masters level allied health professionals should be covered. Speaking as a health educator, we specialize in behavior change/lifestyle modification which is an integral part of successful long term abstinence. It is my experience also that minimal cost sharing should occur (ie., $25 co-payment) to get greater buy in. I've worked in free programs most of my public health career and drop out rates were very high.

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I am very pleased to see this proposal. The medical community still harbors doubts about the effectiveness of treating tobacco addiction. Having Medicare determine that tobacco use cessation counseling is a covered service is an important statement of the treatment value of the service. When combined with effective nicotine replacement therapy and when based on proven methods, such as stages of change models, tobacco use cessation counseling has an acceptable treatment success rate and an acceptable therapuetic profile. This addition to the therapeutic regimen for smokers will save lives.

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I support the CMS efforts to expand coverage of smoking cessation visits. I think patients should be offered counseling, and have it paid for by CMS, if they are smoking and desire to quit. The patient should not have to wait until they have chronic diseases that occurred because they smoke. In addition, I encourage CMS to mandate coverage of smoking cessation pharmacotherapy in addition to counseling- the combination of counseling and pharmacotherapy has shown better rates of success for most patients. I would also expand the coverage of smoking cessation visits to respiratory therapists and phrarmacists. Many of us in these two professions deal one on one with these patients on a daily/weekly basis. We can offer counseling and help patients achieve success in smoking cessation.

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Treating tobacco dependence is one of the most critical healthcare interventions that our government can support. The impact that smoking cessation has on reducing death and disease is astounding. As Medical Director of the UMDNJ-Tobacco Dependence Clinic, we utilize highly effective treatments for even the most dependent smokers. One of the most important barriers to generalizing these treatments remains the cost. What we do as tobacco control providers works...smokers simply need assistance in accessing and affording these treatments. The savings in terms of healthcare dollars, quality of life, and societal benefit will be felt for decades to come.

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Based on the "Clinical Practice Guidelines", ICD-9-CM code 305.1 should be used when tobacco cessation counseling is conducted. Individual, intermediate counseling sessions should last between 3-10 minutes, with a minimum of 4 sessions. Extensive sessions are greater than 10 minutes each (4 minimum required). Billing codes 99401-99404 can be used based on the total amount of time spent with the patient. Mandatory training for tobacco cessation counseling methods should come from the "Treating Tobacco Use and Dependence, Quick Reference Guide for Clinicians."

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I have been a Respiratory Therapist for twenty five years and have worked with a vast number of patients that suffer from heart disease, lung disease, cancer, stroke and many other devastating diseases caused from a lifetime of smoking. Often times this disease begins prior to any manifestation of symptoms. This is why it would be so important to consider that the NCD include all patients with or without the proposed diagnosis for smoking cessation counseling and pharmocotherapies. In the long run this could save Medicare dollars by helping a patient quit smoking prior to the diagnosis, therefore, slowing down the progression of the disease. The respiratory therapist along with other allied health professionals have opportunistic moments to counsel the patient in smoking cessation and make recommendations for smoking cessation pharmacotherapies. Please consider including these health professionals to provide this valued service to all Medicare patients.

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The physiological obstacle to quitting is the addictive nature of nicotine along with the psychological factor that tobacco use is a learned behavior.

Although many smoking cessation programs and techniques are available, the best ones suffer from high rates of relapse. Since behaviour change is a dynamic process the newer models for smoking cessation - the stages of change- refine these programs to support the natural change process. Thus my support for Smoking-Cessation Counseling reimbursement for pharmacist who are the best trained and qualified healthcare professionals to to deliver this care.

Our whole healthcare system is suffering from being over medicated and though these programs require the use of medication upfront they are not the fix for longterm. Throwing more medication at this age group only creates more drug missadventures.

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I am a Respiratory Therapist who has been practicing for 25 years. We are pro-active health providers who know the bad effects of smoking and see it daily. I have been running sessions for several years as part of an outpatient smoking cessation program for adults and an educational program for teens and pre-teens in the schools.I was also part of the Major League Baseball program that was targeting minor leaguers particularly about smokeless tobacco. It is critical that Respiratory Care practioners be included in the program as being the clinical leaders but also allow for reimbursement. Physicians have a role in readiness but a coordinated program that also includes pulmonary rehabilitation is very important. We have the education and training to be the point persons in the arena. We are also the person most frequently identified to provide education for inpatients on smoking cessation as part of the 2005 JCAHO Patient Safety Goals. We have made great strides, but with the abilty to reimburse Respiratory Therapist many more programs could reach more persons to reduce the chronic population below the 21%. This could be tied into the linkage with Breast Cancer awareness (additional risk factors when women smoke).We could address patients in the ED department to recruit for new programs. I hope that this program will include respiratory therapists as part of the program.
Thank you
Alan Roth MS RRT FAARC
Director of Respiratory Care
Memorial Hospital
Modesto, CA 95355

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As a smoking cessation counselor, I can attest to the need for Medicare and private insurance coverage for non-prescription cessation aids such as the patches & gum. The cost of counseling also needs to be covered for clients who are not yet diagnosed with a related illness. Prevention is the way to save lives & money in the long run. Money is the most common deterent for people inquiring about our cessation groups. There is also a great need in the public school system for counseling & at this time money is not available for the needed staff to do this. The state of Virginia desperately needs assistance to remove these barriers particularly in the uninsured population.

Thank you for your consideration,
Carol Horne RN, Health
Educator
Valley Health System
Warren Memorial Hospital
1000 N. Shenandoah Ave.
Front Royal, VA 22630

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At MetroHealth Medical Center in Cleveland Ohio the American Lung Association's Freedom From Smoking program has been made possible through grant funding. It is offered as an out-patient service only, because there is no CPT code that will be paid if the counseling is done by anyone besides a physician. Respiratory Therapist' are trained professionals that could play a key role in counseling. Ohio KeyPro has promoted this locally. I am interested in learning if this coverage applies to both in and out hospital patients. There is a need in both areas. Time spent with the patient and type of training required must be defined. Currently, our class facilitators attend training from the American Lung Association. It is relatively expensive. Training for in-patient counceling should be based upon the US Dept of Health & Human Services publication: Treating Tobacco Use and Dependence. The Clinician's Quick Reference Guide should be provided to physicians, nurses, and respiratory therapists during training. Practice counseling within the class setting would be helpful. A train the trainer approach may work well, or hospital based local training sessions. Travel costs should be minimal, due to current healthcare financial difficulties. Education credits would attract healthcare workers into training. If coverage is based upon time spent, then each session should be 15 - 30 minutes, one on one. The payment should be based upon the average wage in each state plus fringe, paid per hour to nurses and respiratory therapists. The decision to support coverage shows progress toward preventative health!Respectfully,
Margaret Mitchner
Pulmonary Services Practice Coordinator
MetroHealth Medical Center
2500 MetroHealth Drive.
Cleveland, Ohio 44109

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I work with patients with emphysema. Most of them were smokers for many years. I think all smokers should be offered information on the consequences of smoking on your health. Insurance payment is always helpful, especially for fixed-incomes. Also being responsible for a small portion of the cost may help someone buy into the changes that need to be made. Someone certified in teaching smoking cessation is a must for believability. Since everyone can't just quit, payment to help with aids will be important too.

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This is a comment in support of the payment of Smoking Cessation Counseling. I am a Registered Respiratory Therapist & Certified Cessation Tobacco Addiction Counselor by NAADAC. I have worked for 28 years with clients with tobacco related diseases. I have trying for years to assist clients with Respiratory Diseases with cessation.

Since medicare and other medical providers didn't recognize the benefit and need to cover cessation many of the clients felt it couldn't be that important, even when we stated all the facts. They beilieve if the impact could really be so dramatic the medical community and insurance companies would see it as a vital part of their prevention and treatment of not only COPD, but heart disease, stroke, diabetes and most Cancer. Smoking is the leading cause of preventable death & disease in the United States it MUST be a priority.

This is a very positive step in helping the millions of people addicted to nicotine/tobacco in the US. I live in the state of Michigan and we are plagued with a very high prevelance of tobacco use. The provision of medicare acknowledging the need and also recognizing Certified Cessation Counselors as not only physicians & nurses, respiratory therapist, social workers, psychologists is also important.

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I am in strong support of tobacco cessation coverage for Medicare recipients. While there is substantial information in the medical literature to support the efficacy of tobacco cessation counseling and pharmacotherapy, coverage is seriously lacking in this country. Having the forethought to cover tobacco cessation therapy will serve CMS very well in controlling overall medical costs due to tobacco-related morbidity and mortality. I would like to encourage CMS to seriously consider expanding coverage to tobacco-using Medicare recipients who do not yet have tobacco-related health issues. If the goal is to improve health and decrease health care spending, why not consider coverage of these services before the patient suffers the ill effects?

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This issue is crucial. Tobacco usage is rampant, especially among the underserved. We need to be able to take the time to counsel these patients, who are often targeted by the tobacco industry with direct marketing. To do this effectively, we need to be compensated for the counselling. Patients need to be given action plans when they are ready to quit and then be able to return for follow-up just as with any chronic illness. This means seeing them back and being able to bill for this service. Thank you.

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I strongly support this NCD on the intervention of tobacco use. I have worked in healthcare for almost 25 years and have been dismayed that we tell all our patients they must stop using tobacco and have NO services to assist with this difficult addiction. I would hope for an eventual support of intervention program for both inpatients and outpatients. Until then, supporting the costs of bedside intervention, a stand-alone visit, and 2 counseling sessions is a wonderful first step. The costs to support these interventions will be far less than the costs of the eventual tobacco-related disease.

I would like to ask that we consider this coverage for all Medicare/Medicaid patients who use tobacco - not just those exhibiting tobacco-related disease. It costs far too much to treat the results of the addiction than it does to prevent it.

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According to the Campaign for Tobacco-Free Kids, the toll of tobacco in Virginia is more than a little expensive. State Medicaid program payments caused by tobacco use: 313 Million

I teach smoking cessation and cannot provide nicotine replacement patches, gum and other products, due to budgetary limits.

The $ spent on health care costs associated with smoking amount to more than $1.62 billion. We know Prevention works, and is very cost effective. It seems very unproductive to pay and to reward people for disease producing behavior, but not to prevent it. We can and must modify this attitude. Prevention Works!

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This is a great opportunity for pharmacists to provide a much needed resource to our nation's medicare recipients. As our elderly continue to smoke, so do our Length of Stays in our nation's hopsitals and tax dollars due to smoking related disease states, and the increased number of Vent days in the ICU due to lung deterioration/collapse. If medicare would work on getting pharmacists PROVIDER STATUS then some of this burden could be alleviated, because we as pharmacists both in-house and in the community are the most accessable to our nation's medicare population. If the pharmaceutical manufacturers will work with us by donating there products or at least giving reduced prices to these patients this will benefit our medicare population. This is not the final end point, the cycle does not end with the patches. The continuation of counseling (where pharmacists again are in a very prominent position) and behavioral modification is just as important as the patches, becuase you can't have one without the other. Paying only for people who have a documented disease state related to smoking is a step in the right direction, but only touches a small percentage of the population that will desire to quit. With direct to consumer advertising playing such a role in today's society, we are now seeing people who have not been diagnosed with a disease state related smoking disorder that are also wishing to stop smoking.

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I strongly support this NCD on the intervention of tobacco use. I have worked in Cardiology for almost 15 years and have been dismayed that we tell all our patients they must stop using tobacco, but then typically offer NO services to assist with this difficult addiction. After a national review of cessation programs revealed the most successful intervention in the Mayo Clinic inpatient model (resulting in approximately 25-28% quit rate at 1 yr), I would hope for an eventual support of such an in-patient type of intervention. Until then, supporting the costs of bedside intervention, a stand-alone visit, and 2 counseling sessions is a wonderful first step. I also greatly appreciate the 2x/year attempts that would be considered, since we know that typically tobacco users need 5-7 attempts before officially and finally quitting. The costs to support these interventions will be far less than the costs of the eventual tobacco-related disease.

I would like to ask that we consider this coverage for all Medicare/Medicaid patients who use tobacco - not just those exhibiting tobacco-related disease. It costs far too much to treat the results of the addiction than it does to prevent it. If a man has an MI at 65 and uses tobacco, he can get coverage, but his wife - also 65 - cannot? Often the spouse is also a tobacco user - and the attempts will not be successful if not supported by the spouse. Let them both come.

I would ask that you also please consider adding pregnant women and new mothers to the group of qualified coverage. We see so many Medicaid mothers who use tobacco- if we can assist with their cessation, it will have exponential impact.

Finally, regarding training, I believe all licensed and non-licensed clinical staff can be trained to the brief intervention and general education/stand-alone sessions. For counseling sessions, either social workers, addictive disease counselors, or clinical psych staff would be the best to offer such services if the reimbursement will justify this level of service.

Please feel free to call on me for additional comment.

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It is never too late to quit. 23% of my clients are over the age of 60 years with 8% being > than 70! We've had excellent quit results in our program (38%-56% 1 year quit rate) because as a full time Master Certified Tobacco Treatment Specialist I am able to provide the best practice strategies to any client with just one quick referral. Tobacco treatment is most cost effective when delivered by the experts. A program based on the Diabetes Education model using Tobacco Treatment Specialists would be most efficacious.

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Tobacco Use Cessation counseling for those receiving Medicare benefits is a good step in the right direction, but should also include access/coverage for nicotine replacement products as research shows that quit rates go up significantly when counseling is combined with NRT.

Also, I am in favor of providing this benefit to all receiving Medicare, not just those with documented chronic disease. Seniors who continue to smoke WILL cost Medicare $$, if not this year when there has been a diagnosed disease, but in the years to come.

The more people we can help quit the less overall health care dollars our country will spend.

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As a Care Manager, I assess Medicare clients everyday to provide education, assistance with prescription drug costs, referrals, and community resources. Nicotine is highly addicting for both body and mind. I believe that it will take more than just counseling to get people to quit smoking. Alot of the people that I speak to would like to quit, but can not afford the medication to help with nicotine withdrawal or use of nicotine replacement therapy. Can Medicare include drug assistance along with the cessation counseling?

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