Counseling to Prevent Tobacco Use

June 27, 2010

Department of Health and Human Services
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Ave., SW
Washington, DC 20201

Attention: Louis B. Jacques, MD, Director, Coverage and Analysis Group

[Submitted electronically to: CAGinquiries@cms.hhs.gov]

RE: Proposed Decision Memo for Counseling to Prevent Tobacco Use (CAG-00420N)

Dear Sir/Madam:

The American Pharmacists Association (APhA) respectively submits the following comments to the Centers for Medicare & Medicaid Services (CMS) in response to the request for public comment on the Proposed Decision Memo for Counseling to Prevent Tobacco Use (CAG-00420N), posted on CMS’ Web page (www.cms.gov) May 28, 2010. The memo discusses CMS’ proposal to cover two individual tobacco cessation counseling attempts per year for certain Medicare beneficiaries. Specifically, CMS proposes to cover tobacco cessation counseling for outpatient and hospitalized Medicare beneficiaries: who use tobacco, regardless of whether the patient has signs and symptoms of tobacco-related disease; who are competent and alert at the time that counseling is provided; and whose counseling is furnished by a qualified physician or other Medicare-recognized practitioner. APhA, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, managed care organizations, hospice settings, and the uniformed services.

APhA commends the Agency for recognizing the need to expand Medicare’s preventive services to cover counseling for tobacco cessation. As cited in the memo, tobacco use is the leading cause of preventable morbidity and mortality in the U.S. and is a major contributor to the nation’s increasing medical costs. The lack of Medicare coverage for tobacco cessation counseling for asymptomatic adults and pregnant women represents a significant gap in caring for the Medicare covered population. Addressing this important issue by providing the proposed tobacco cessation services will improve care for beneficiaries and undoubtedly result in reduced costs to the health care system overall.

In general APhA supports CMS’ recommendations, which support the recommendations of the U.S. Department of Health and Human Services Public Health Service (PHS) Clinical Practice Guideline on “Treating Tobacco Use and Dependence: 2008 Update”. However, to maximize the benefits to Medicare beneficiaries, public health, and the health care system as a whole, APhA strongly recommends the Agency include payment to all qualified healthcare providers (including providers not recognized as Medicare Part B providers, such as pharmacists), for these counseling services. This recommendation echoes the recommendations made by several who commented during the initial public comment period, as cited in the memo. Excluding pharmacist-provided tobacco cessation counseling services would limit the breadth and scope of the benefits that the Agency intends to provide thereby limiting the proposals’ impact on health outcomes and program costs. Furthermore, excluding pharmacist-provided tobacco cessation counseling services fails to recognize that patients are likely to obtain their tobacco cessation products at a pharmacy; and pharmacists, one of the most accessible health care providers, are readily available to serve as a coach to these patients.

Supportive Clinical Data

Pharmacists have been providing tobacco cessation counseling services in their practices for over two decades, effectively assisting an expansive, diverse population of patients to cease the use of tobacco, improve their overall health and contribute to reduced health care costs to the health care system. A wide body of published literature as well as anecdotal non-published information supports pharmacists’ contributions to public health through smoking cessation counseling.

• A 2009 published study by Dent et al. in the Annals of Pharmacotherapy, demonstrated in a randomized trial the effectiveness of pharmacist-delivered smoking cessation programs. The study was conducted at the Veterans Health Administration (VA) community-based outpatient clinic in the Rocky Mountain region and compared the effectiveness of face-to-face counseling by a pharmacist or standard counseling over the phone. The study demonstrated a 28% abstinence rates at the end of 6 months in the pharmacist delivered face-to-face treatment group and 11.8% in the standard telephone session control group (p<0.041).(i)
• A 2002 published study by Kennedy et al. demonstrated the results of a smoking cessation clinic in a community pharmacy practice from April 1997 to December 1999. Investigators examined the impact on the effectiveness of smoking cessation provided by pharmacists. Of the 48 patients, 12 (25%) abstained from smoking cigarettes for 12 months or more beyond their predetermined quit dates. Abstinence rates for 1, 3, and 6 months were 43.8%, 31.3% and 25% respectively. In comparison with other types of tobacco cessation interventions, the study demonstrated that a community pharmacist smoking cessation clinic achieved greater long-term smoking cessation rates. (ii)
• A 1995 published study by Smith et al. in American Pharmacist, examined the outcomes of smoking cessation on a broad population of 40,200 patients and more than 6,500 participating pharmacy locations. One year after the program began, a survey of participants revealed that patients who had enrolled in a comprehensive behavioral smoking cessation program, combined with counseling from a pharmacist, had a quit rate of 62% at the end of treatment and 45% at the end of 10 months. (iii)
• Nationwide, many other pharmacist-provided tobacco cessation programs, in the private and public sector, have successfully helped patients improve their health and reduce health care costs. An example of one such program is the Delaware Quitline, a program which has been providing tobacco cessation counseling by pharmacists since 2001. This program, supported by the Federal Tobacco Settlement fund, has assisted thousands of Delaware residents in ceasing their use of tobacco products. In addition, several states including Alaska, Missouri, and Pennsylvania have incorporated pharmacists as providers of tobacco cessation services in their State Medicaid Programs. (iv, v)

The data, which demonstrates that pharmacists have successfully assisted thousands of patients through tobacco cessation counseling, supports authorizing Medicare payment for the proposed tobacco cessation counseling when provided by pharmacists.

Leveraging Pharmacists’ Accessibility

As cited in the section “Disparities in Counseling for Smoking Cessation”, access to tobacco cessation services by those of low socioeconomic status and/or limited formal education as well as other groups of beneficiaries must be addressed. Beneficiaries must be ensured convenient and accessible care to ensure adequate levels of participation. Pharmacists are the most readily accessible health care providers both in the community/ambulatory care environment. In the community sector alone, more than 65,000 pharmacies are available, many with extended hours and convenient access to the patient care services that pharmacists provide.

Pharmacists have successfully demonstrated the ability to provide important patient care services on a broad scale. Notably, pharmacists have impacted public health through their work with immunizations. In 2009, over 100,000 (a significant portion of all U.S. licensed pharmacists) were trained to administer vaccines and over 16 million vaccinations were administered by pharmacists. In 2009, pharmacists served a very important role in providing vaccinations for both the H1N1 flu as well as seasonal flu. In addition, pharmacists year round provide vaccination services for many other vaccine preventable illnesses. These services represent a significant contribution by pharmacists, as health care providers, to our nation’s public health; and demonstrate the significant impact pharmacists can provide in public health initiatives nationwide. Pharmacists are ready to build on the successes of immunization to better ensure increased beneficiary access to Medicare-covered tobacco cessation counseling services. APhA appreciates the opportunity to provide comments to the Agency on this important issue. We strongly encourage CMS to include pharmacists as providers of tobacco cessation counseling to enhance the proposed benefit for Medicare beneficiaries, improve public health, and reduce costs. If you require additional information or would like to discuss any of the recommendations further, please contact, Marcie Bough, APhA’s Director of Federal Regulatory Affairs via email at mbough@aphanet.org, or at 202-429-7538.

Sincerely,

Thomas E. Menighan, BSPharm, MBA, FAPhA
Executive Vice President and CEO

cc: Brian Gallagher, RPh, JD, Senior Vice President, Government Affairs
Anne Burns, BPharm, Vice President, Professional Affairs
Kristina E. Lunner, Vice President, Government Affairs
Marcie A. Bough, PharmD, Director, Federal Regulatory Affairs
James Owen, PharmD, Director, Professional Affairs

i. Dent LA, Harris KJ, Noonan CW. Randomized Trial Assesing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation. The Annals of Pharmacotherapy. 2009; 43 (2): 194-201.0
ii. Kennedy DT, Giles JT, Chang ZG, Small RE, Edwards JH. Results of a Smoking Cessation Clinic in Community Pharmacy Practice. J Am Pharm Assoc. 2002; 42 (1)
iii. Smith MD, McGhan WF, Lauger G. Pharmacist Counseling and Outcomes of Smoking Cessation. Am Pharm. 195. NS35 (8) : 20-9; 32.
iv. http://www.hss.state.ak.us/publicnotice/PDF/194.pdf. Accesed June 24, 2010.
v. http://www.dpw.state.pa.us/PubsFormsReports/NewslettersBulletins/003673169.aspx?BulletinId=111. Accessed June 24, 2010.
vi. American Pharmacists Association Internal Databases. Accessed June 16, 2010.

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As a practicing family physician, researcher and educator, I am writing to offer my strong support for the Centers for Medicaid and Medicare Service''s proposed decision to expand tobacco cessation counseling to patients who may not yet have signs and symptoms of tobacco-related disease. As a physician who is dedicated to preventing disease before it happens (primary prevention), adding coverage for this counseling would further enable the approximately 100,000 family medicine physicians in this country to provide this valuable counseling.

Medical evidence continues to mount in support of smoking cessation counseling. The clinical practice guidelines "Treating Tobacco Use and Dependence," found that smoking cessation medications alone or counseling alone were effective. However, the combination of smoking cessation medications with counseling were much more effective than either alone, raising the chances of successfully quitting by 40-70%. In addition, new counseling methods such as "Motivational Interviewing" have been shown to be effective in increasing future quit attempts with patient unwilling to quit smoking currently. The most recent systematic review on Motivational Interviewing from the Cochrane collaboration showed that smoking cessation counseling using Motivational Interviewing was 3.47 times more likely to lead to successfully quitting.

However, coverage for these services is necessary in light of recently passed healthcare reform, where improved access for patients is expected, but much uncertainty exists on the ability to provide all the treatment and physician services that will be needed to ensure cost-effectiveness in the long run. Providing coverage for prevention services such as smoking cessation counseling will be essential for ensuring long-term success of health care reform efforts and for sustaining the federal Medicare program. Current efforts to reduce payment to physicians threaten the viability of Medicare and it is essential to avoid any further cuts in payments in a program that already does not reimburse adequately or fairly for cognitive services provided by primary care physicians.

I highly recommend CMS moving forward with adding this coverage after the public comment period is concluded. Over 100,000 family physicians across the country would be standing by and ready to deliver these services when this new benefit is added. This has great potential to reduce mortality and morbidity from the leading preventable cause of death in the United States. This is especially true for beneficiaries over the age of 65, as quitting at this age can still lead to significant gains in life expectancy and decreased morbidity from smoking-related illnesses.

Thank you for the opportunity to comment and for your consideration.

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On behalf of ClearWay Minnesota, I would like to thank the Centers for Medicare and Medicaid Services (CMS) for the opportunity to provide comment on the proposed expansion of tobacco cessation counseling to all Medicare beneficiaries.

ClearWay Minnesota is an independent, nonprofit organization that improves the health of all Minnesotans by reducing tobacco use and exposure to secondhand smoke through research, action and collaboration. We are an independent nonprofit funded by three percent of the settlement Minnesota received from the tobacco companies in 1998. Since 2001, ClearWay Minnesota’s QUITPLAN Services have helped over 17,000 Minnesotans successfully quit using tobacco.

We support the CMS proposal to cover two individual tobacco cessation counseling attempts per year with a maximum of four intermediate or intensive sessions totaling up to eight sessions per year per beneficiary. We would also like to emphasize the importance of this benefit being made available to all Medicare beneficiaries who use tobacco, whether or not they have signs or symptoms of tobacco-related disease.

At the same time, we respectfully request that CMS reconsider its position on reimbursement of quitline services for Medicare beneficiaries and expand the definition of qualified providers to include quitlines. Phone-based tobacco cessation programs are cost-effective, affording accessibility to treatment that reaches beyond the clinical setting; and it is widely accepted that evidence-based telephone counseling is an efficacious intervention (as noted in Section 5 ofthe CMS proposal under the “Treating Tobacco Use and Dependence: Clinical Practice Guideline: 2008 Update” key recommendations). In addition, quitlines can further minimize barriers to making quit attempts by allowing tobacco users to take advantage of opportunities when they are ready to quit.

This nation’s quitline infrastructure is well established with all 50 states, the District of Columbia, Puerto Rico, and Guam operating quitline services. The quitline community is well organized and supported by its national membership association, the North American Quitline Consortium with a goal of providing consistent evidence-based cessation services to its constituencies throughout the United States and it’s territories.

Thank you for the opportunity to comment on this proposal, and I would be happy to provide additional information on the Minnesota experience if requested.

Sincerely,

David J. Willoughby
CEO
ClearWay Minnesota

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As a practicing family physician and educator, Iam writing to offer my strong support for theCenters for Medicaid and Medicare Service''''sproposed decision to expand tobacco cessationcounseling to patients who may not yet have signsand symptoms of tobacco-related disease. As aphysician who is dedicated to preventing diseasebefore it happens (primary prevention), addingcoverage for this counseling would further enablethe approximately 100,000 family medicinephysicians in this country to provide thisvaluable counseling.

Medical evidence continues to mount in support ofsmoking cessation counseling. The clinicalpractice guidelines "Treating Tobacco Use andDependence," found that smoking cessationmedications alone or counseling alone wereeffective. However, the combination of smokingcessation medications with counseling were muchmore effective than either alone, raising thechances of successfully quitting by 40-70%. Inaddition, new counseling methods such as"Motivational Interviewing" have been shown to beeffective in increasing future quit attempts withpatient unwilling to quit smoking currently. Themost recent systematic review on MotivationalInterviewing from the Cochrane collaborationshowed that smoking cessation counseling usingMotivational Interviewing was 3.47 times morelikely to lead to successfully quitting.

However, coverage for these services is necessaryin light of recently passed healthcare reform,where improved access for patients is expected,but much uncertainty exists on the ability toprovide all the treatment and physician servicesthat will be needed to ensure cost-effectivenessin the long run. Providing coverage forprevention services such as smoking cessationcounseling will be essential for ensuringlong-term success of health care reform effortsand for sustaining the federal Medicare program. Current efforts to reduce payment to physiciansthreaten the viability of Medicare and it isessential to avoid any further cuts in payments ina program that already does not reimburseadequately or fairly for cognitive servicesprovided by primary care physicians.

I highly recommend CMS moving forward with addingthis coverage after the public comment period isconcluded. Over 100,000 family physicians acrossthe country would be standing by and ready todeliver these services when this new benefit isadded. This has great potential to reducemortality and morbidity from the leadingpreventable cause of death in the United States. This is especially true for beneficiaries over theage of 65, as quitting at this age can still leadto significant gains in life expectancy anddecreased morbidity from smoking-related illnesses.

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On behalf of the American Heart Association(AHA), including the American Stroke Association (ASA) and over 22.5 million AHA and ASA volunteers and supporters, we appreciate the opportunity to submit our comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed coverage decision for counseling to prevent tobacco use and tobacco-caused disease.

Under the proposed coverage decision, CMS would expand Medicare coverage of tobacco cessation counseling to all Medicare beneficiaries who use tobacco. This represents a dramatic expansion of Medicare’s current cessation benefit which limits counseling to beneficiaries with signs or symptoms of a tobacco-related disease or who are taking a therapeutic agent that is affected by tobacco use. AHA strongly supports the proposed expansion; quitting smoking can have a substantial impact on health and cessation counseling increases the likelihood that tobacco users will quit. By expanding Medicare coverage to asymptomatic beneficiaries, CMS can help these beneficiaries quit before tobacco-related symptoms, which are the result of tobacco-related damage, appear.

We are also pleased that the proposed coverage decision includes the recommendations AHA made in our December 22, 2009 letter to the Agency, such as providing coverage for multiple cessation attempts a year and multiple counseling sessions for each quit attempt. According to the proposed decision memo, CMS will provide coverage for two cessation attempts a year and up to four counseling sessions per attempt. We support the Agency’s proposal to provide coverage for two quit attempts a year; however, we note that the limit of four counseling sessions per quit attempt represents the minimum number of sessions recommended by the Surgeon General’s Clinical Practice Guideline for Treating Tobacco Use and Dependence: 2008 Update. The Clinical Practice Guideline recommends “person-to-person treatment delivered for four or more sessions…therefore, if feasible, clinicians should strive to meet four or more times with individuals quitting tobacco use.” Based on the Guideline’s finding that tobacco abstinence rates appear to increase as the number of counseling sessions increase, it may be appropriate for CMS to raise the number of counseling sessions per quit attempt. We request that the Agency review the existing evidence regarding the impact of the number of treatment sessions and revise the proposed coverage decision as needed.

In addition, if CMS decides to increase the number of treatment sessions per quit attempt, we recommend that the Agency make the same revision to the existing national coverage determination for smoking and tobacco-use cessation counseling (210.4) which will continue to provide tobacco cessation coverage for Medicare beneficiaries with a tobacco-related disease. We believe both symptomatic and asymptomatic beneficiaries should have access to the same evidence-based cessation benefit.

In closing, we reiterate our strong support for the Agency’s proposal to expand Medicare coverage of tobacco cessation counseling. Expanding coverage of tobacco cessation counseling to all Medicare beneficiaries is a valuable step toward reducing tobacco use among the Medicare population, and we appreciate CMS’s decision to initiate this coverage analysis. However, in order to ensure that the cessation benefit provides Medicare beneficiaries with the best chance of success, we request that CMS examine the evidence regarding the optimal number of counseling sessions per quit attempt and increase that number beyond four if appropriate.

Thank you for consideration of our comments. If you have any questions, please do not hesitate to contact Susan Bishop, MA, Regulatory Affairs Manager, at (202) 785-7908 or susan.k.bishop@heart.org.

Sincerely,

Ralph L. Sacco, MD, FAHAAHA President

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June 25, 2010

Louis B. Jacques, MD
Director, Coverage and Analysis Group
7500 Security Boulevard
Mail Stop C1090
6Baltimore, MD 21244-1850

Dear Dr. Jacques:

We are writing in response to the Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Counseling to Prevent Tobacco Use (CAG-00420N).

We support CMS’s decision to use the authority it was given in the Medicare Improvements for Patients and Providers Act (MIPPA) to add coverage of preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) to Medicare and are pleased that CMS is proposing to expand coverage for evidence-based tobacco cessation counseling to all Medicare beneficiaries. More than 3.5 million Medicare beneficiaries are current smokers. By expanding coverage of tobacco cessation counseling services to all Medicare beneficiaries, CMS can greatly improve access to these services, help more seniors to quit and reduce the terrible toll of tobacco.

Today, Medicare coverage of tobacco cessation is limited. Medicare covers counseling services but only if a beneficiary presents with a tobacco-related disease or uses medications that are adversely impacted by tobacco use. Medicare also covers smoking cessation pharmacotherapy prescribed by a physician. We agree with CMS’s determination that the evidence clearly shows that all Medicare beneficiaries would benefit from smoking cessation counseling.

While we support expanding Medicare coverage for tobacco cessation counseling to all Medicare beneficiaries, we do not believe that CMS’s proposal does enough to ensure that Medicare beneficiaries will have access to the evidence-based services they need to help them quit. In its national coverage analysis, CMS appropriately references the U.S. Public Health Service (PHS) Clinical Practice Guideline Treating Tobacco Use and Dependence, updated in May 2008. The PHS Clinical Practice Guideline is the result of a rigorous review of the most recent available scientific literature on tobacco cessation and includes the most comprehensive summary of the evidence with regard to tobacco cessation interventions. The USPSTF recommendation for tobacco cessation services also explicitly refers to the PHS Guideline. Unfortunately, CMS’s proposed coverage decision does not adhere to the PHS Guideline in key areas.

Recommendation #1: Cover proactive telephone counseling (quitlines) and group counseling in addition to individual in-person counseling.

Quitting is hard and because of the addictive power of nicotine, most smokers fail when they try to quit smoking on their own. Unfortunately, smoking cessation treatment is not one size fits all, and different treatment approaches may be more or less effective for different people. To ensure that Medicare beneficiaries have access to the services they need to help them quit, it is critical that all tobacco cessation counseling formats proven to be effective are covered by CMS.

The PHS Guideline found that proactive telephone counseling (quitlines), group counseling and individual counseling formats are all effective in reducing tobacco use. According to the Guideline, tobacco cessation quitlines significantly increase abstinence rates compared to minimal or no counseling. Among the top ten key guideline recommendations is: “Telephone quitline counseling is effective with diverse populations and has broad reach. Therefore, clinicians and health care delivery systems should both ensure patient access to quitlines and promote quitline use.” Quitlines provide easy access to cessation services and are a cost-effective and efficient way to reach a large number of smokers. Quitline services can also be tailored to the needs of specific populations, including senior smokers. In fact, the PHS Guideline indicates that certain issues particular to seniors, such as mobility and the use of medications, may make the use of telephone counseling particularly promising for this population. In addition, a study of the Medicare Stop Smoking Program (MSSP), the first large-scale demonstration of the effectiveness and cost-effectiveness of Medicare coverage of smoking cessation services, found that quitline counseling combined with pharmacotherapy to be the most effective approach that was analyzed.

Tobacco cessation quitlines are also included as a key component in the Centers for Disease Control and Prevention’s Best Practices for Tobacco Control Programs. The U.S. Department of Health and Human Services currently provides funding for quitline infrastructure and services because it has determined that quitlines are an effective intervention to help tobacco users quit. While all states now provide some level of quitline services, these services are nowhere near the level that the Centers for Disease Control and Prevention (CDC) recommends and are therefore simply not available to the vast majority of smokers. Most state quitlines serve one percent or less of the total tobacco users in each state while the CDC Best Practice Guidelines indicates that a state quitline could serve eight percent of tobacco users.

The PHS Guideline is also clear in its recommendation of group counseling as an effective format for cessation counseling, however, the PHS Guideline does not single out a particular format as preferred. The Guideline states that “the provision of intratreatment social support [is] associated with significant increases in abstinence rates” and is one of the most important elements of an effective cessation counseling session. While social support can be addressed in individual counseling, group counseling sessions come with a built-in social support group. In its recommendations specifically for older smokers, the Guideline indicates that social support is an effective method of helping older smokers quit, mentioning that “buddy support programs” are particularly effective.

The PHS Guideline is not the only guiding document that supports the importance of including group cessation counseling in any insurance benefit. CDC’s Best Practices for Tobacco Control Programs also recommends that tobacco use treatment include group counseling.

Efforts by the business community to define an appropriate tobacco cessation benefit also recognize the importance of covering all counseling formats. The National Business Group on Health has developed a purchaser’s guide to help employers design benefits packages for their employees. The Business Group recommends that employers cover multiple counseling formats in their cessation benefits packages. Counseling options include telephone-based programs, individual counseling programs, group programs and Internet self-help programs.

Recommendation #2: Increase the number of counseling sessions covered during each quit attempt from a maximum of four sessions to a greater number of sessions consistent with the PHS Guideline and current practice.

CMS is proposing coverage of a maximum of four counseling sessions per quit attempt. This proposal differs from the PHS Guideline and may unnecessarily limit access to additional counseling sessions that would help Medicare beneficiaries to quit tobacco use.

The PHS Guideline confirms that there is a strong dose-response relationship between the frequency and length of the counseling sessions and successful quit attempts – more or longer sessions improve quit rates. The PHS Guideline finds that an effective strategy for producing high long-term abstinence rates is “relatively intense cessation counseling (e.g., four or more sessions that are each 10 minutes or more in length).” The Guideline recommends that if possible, clinicians should strive to meet with individuals four or more times. The PHS Guideline recommendations regarding the number of sessions is consistent with other groups including the National Business Group on Health which recommends that employers cover two courses of six counseling sessions per calendar year.

CMS’s national coverage decision should set a maximum number of counseling sessions per quit attempt at a level that is higher than four. Given the economic burden of tobacco and the dose-response relationship documented in the PHS Guideline, it is critical that CMS not arbitrarily set a maximum number of sessions. CMS appears to have simply proposed covering the minimum number of counseling sessions found to be effective in the PHS Guideline. Instead, CMS should cover the number of sessions that the evidence suggests will assist the greatest number of Medicare beneficiaries to quit. To determine the maximum number of sessions, CMS should look at the PHS Guidelines as well as the current practice of effective cessation counseling programs.

Recommendation #3: Ensure that the tobacco cessation counseling benefit is promoted to all Medicare beneficiaries.

A comprehensive cessation benefit must not only include proven effective services, but must also include efforts to increase demand for cessation services and promote the use of these services. To achieve maximum benefit, CMS should encourage smokers to quit, make all Medicare beneficiaries aware of the cessation counseling benefit as well as the tobacco cessation medications covered through Part D, and provide them with information about where they can access these services. For example, CMS could include information to highlight the new benefit in the “Medicare and You” publication, on Medicare.gov, and as part of the Welcome to Medicare physical examination. CMS should also utilize the Medicare Learning Network and other means to inform physicians and other health professionals about the expanded counseling coverage and raise awareness of the effectiveness of counseling at increasing the chances of quitting successfully.

Finally, while outside the scope of this coverage determination and the authority under MIPPA that CMS has for adding preventive services, we believe FDA-approved tobacco cessation medications, including over-the-counter medications, should be covered by Medicare, Medicaid and all private health plans, as the USPSTF recommends.

Thank you for the opportunity to provide comment on the CMS proposal. We look forward to your final decision memorandum.

Sincerely,

Christopher W. Hansen
President
American Cancer Society Cancer
Action Network
Charles D. Connor
President and Chief Executive Officer
American Lung Association
Rob Gould
President and Chief Executive Officer
Partnership for Prevention

Matthew L. Myers
President
Campaign for Tobacco-Free Kids

Cheryl Healton
President and Chief Executive Officer
American Legacy Foundation

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These comments are in response to the question of whether it is reasonable for CMS to provide coverage for tobacco cessation services to people who smoke but who do not yet have evidence of a tobacco-related illness (such as coronary heart disease (CHD)).

Using previously-collected data from the Women’s Health Initiative, our research team compared the risk of having a cardiovascular disease event or dying among women 1) who had CHD at study entry but who never smoked (“never-smokers-with-CHD,” n=1465) vs. 2) those who did not have CHD but were currently smoking at study entry (“smokers-without-CHD,” n=7729). We calculated multivariable adjusted hazard ratios (AHR) for several cardiovascular events, total mortality, and cause-specific mortality in each group over 12 years of follow up. In multivariable models adjusting for baseline factors including age, race, education, medical co-morbidities, personal habits, and physical and laboratory measurements, smokers-without-CHD (vs. never-smokers- with-CHD) had similar risk of stroke (AHR:0.90, 95% CI(0.68-1.18)), CHD-related death (AHR:0.75, 95% CI(0.54-1.06)), and cardiovascular disease (CVD)-related death (AHR:0.84, 95%CI (0.65-1.08)), but higher risk of cancer-related death (AHR:3.41, 95% CI(2.45-4.74) and total mortality (AHR:1.39, 95% CI(1.19-1.62)). Risk of all outcomes increased with increasing pack years. The main conclusion from these data is that the risk of all-cause mortality is 39% higher among women who smoke (but who do not have CHD) as compared to women who have CHD and have never smoked. Thus, smoking is associated with risks for cardiovascular disease and death which are similar in magnitude to risks conferred by CHD. In the case of all-cause mortality, the risk of smoking is even higher. The data are limited by several factors, including the all-female sample ages 50-79 at baseline entry into the study. Thus, results may not be fully generalizable to men, younger individuals, or those of different racial/ethnic groups. However, these data demonstrate that even among individuals who do not yet have smoking related illness (in this case, CHD), smoking carries a significant risk of cardiovascular disease and death. The results support that position that all smokers should be provided assistance in quitting smoking.

Disclosure: Dr. Tindle presented these findings orally at the Society for General Internal Medicine on 4/30/10 in Minneapolis, MN. The manuscript has not yet been published but is currently under review.

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The Multi-State Collaborative for Health Systems Change to Address Tobacco Use, comprised of 19 state-level tobacco control programs, New York City, and national partners, strongly supports the proposed extension of tobacco cessation counseling to all Medicare beneficiaries. This is an important step that the Centers from Medicare and Medicaid Services can take to ensure that all tobacco users in the US have access to evidence-based, barrier-free tobacco cessation medications and behavioral counseling.

The US Public Health Service Guideline: Treating Tobacco Use and Dependence recommends that all clinicians identify tobacco users, complete brief interventions, prescribe medication, and refer for more intensive counseling. Sadly, clinicians and health care systems often fail to treat tobacco dependence consistently and effectively. The lack of covered medications and a maze of restrictions and exclusions, where coverage exists together with the lack of adequate reimbursement for counseling remain significant barriers. Expanding the Medicare counseling benefit to all recipients is one important step to reduce these barriers and ultimately to reduce the heavy cost of tobacco use to society and individuals.

A recent report published by Land T., Warner D et al. in Massachusetts points to the significant contribution comprehensive benefit coverage for tobacco cessation can make to reductions in prevalence, especially combined with significant promotion:

"In July 2006, the Massachusetts health care reform law mandated tobacco cessation coverage for the Massachusetts Medicaid population. The new benefit included behavioral counseling and all medications approved for tobacco cessation treatment by the U.S. Food and Drug Administration (FDA). Between July 1, 2006 and December 31, 2008, a total of 70,140 unique Massachusetts Medicaid subscribers used the newly available benefit, which is approximately 37% of all Massachusetts Medicaid smokers. Given the high utilization rate, the objective of this study is to determine if smoking prevalence decreased significantly after the initiation of tobacco cessation coverage.

METHODS AND FINDINGS: Smoking prevalence was evaluated pre- to post-benefit using 1999 through 2008 data from the Massachusetts Behavioral Risk Factor Survey (BRFSS). The crude smoking rate decreased from 38.3% (95% C.I. 33.6%-42.9%) in the pre-benefit period compared to 28.3% (95% C.I.: 24.0%-32.7%) in the post-benefit period, representing a decline of 26 percent. A demographically adjusted smoking rate showed a similar decrease in the post-benefit period. Trend analyses reflected prevalence decreases that accrued over time. Specifically, a joinpoint analysis of smoking prevalence among Massachusetts Medicaid benefit-eligible members (age 18-64) from 1999 through 2008 found a decreasing trend that was coincident with the implementation of the benefit. Finally, a logistic regression that controlled for demographic factors also showed that the trend in smoking decreased significantly from July 1, 2006 to December 31, 2008.

CONCLUSION: These findings suggest that a tobacco cessation benefit that includes coverage for medications and behavioral treatments, has few barriers to access, and involves broad promotion can significantly reduce smoking prevalence."¹

We urge the CMS to move forward with this critical public health measure when the public comment period has concluded, with some revisions.

Although we fully support expanding the current benefit to all Medicare members, we remain concerned that the Medicare tobacco cessation benefit still presents several barriers to both the tobacco user and providers, as described below. Medicare does not presently provide Medicare recipients low or no-cost access to over the counter tobacco treatment. The significant reduction in tobacco use among Medicaid members cited above was due in part to barrier free access to both prescription and OTC pharmacotherapy: while 37% of Medicaid smokers used the benefit, nearly all used the medications. Only 1.5% used counseling. It is unlikely that CMS will realize the full health and economic benefits of reductions in tobacco use, if our seniors do not have ready-access to free or low-cost over-the-counter pharmacology (self-administered).

To increase access to both brief and more intensive interventions, CMS should consider expanding the definition of qualified providers. Currently the only providers eligible to bill Medicare directly for cessation counseling are physicians, other prescribing providers, hospitals, clinical psychologists/psychiatrists and occupational therapists. Increasingly, providers such as Respiratory Therapists, RNs, chemical dependency counselors, social workers and health educators also have responsibility for tobacco interventions.

We also respectfully request that CMS revisit the exclusion of tobacco cessation quitlines and the limitation on counseling sessions to four (4) per quit attempt. As demonstrated by Joyce et al., quitlines, in conjunction with pharmacotherapy (nicotine patch), have been found to be an effective means of reducing smoking in the elderly.² Since tobacco dependence treatment groups typically run for six to eight weeks, an alternative would be to increase the counseling sessions to six (6) per attempt, or offer up to eight (8) counseling sessions per year.

Thank you,

On behalf of the Multi-State Collaborative for Health Systems Change to Address Tobacco Use:
Donna Warner, MA, MBA, Collaborative Managing Partner
Caroline Cranos, MPH, Collaborative Coordinator

1 PLoS One. 2010 Mar 18;5(3):e9770. Medicaid coverage for tobacco dependence treatments in Massachusetts and associated decreases in smoking prevalence. Land T, Warner D, Paskowsky M, Cammaerts A, Wetherell L, Kaufmann R, Zhang L, Malarcher A, Pechacek T, Keithly L.; Massachusetts Tobacco Control Program, Boston, Massachusetts, United States of America. Thomas.Land@state.ma.us
2 Joyce GF, et al. The Effectiveness of Covering Smoking Cessation Services for Medicare Beneficiaries. Health Serv Res. 2008 Dec;43(6):2106-23. Epub 2008 Sep 8.

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June 25, 2010

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage determination (NCD) for Counseling to Prevent Tobacco Use (CAG-00420N). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
AHIP and our member plans support CMS's efforts to ensure that Medicare beneficiaries receive access to safe and effective preventive health services, procedures, and treatments that can improve health outcomes, as determined by current and robust clinical evidence. As AHIP and our members stated in our prior comments on this issue in December 2009, our member plans support counseling as an effective approach to reduce tobacco use to outpatient and hospitalized Medicare beneficiaries. We also agree with CMS's proposed appropriateness criteria for persons entitled to benefits under Part A or enrolled under Part B who would qualify to receive tobacco prevention counseling: beneficiaries who use tobacco, regardless of whether the patient has signs and symptoms of tobacco-related disease; beneficiaries who are competent and alert at the time that counseling is provided; and beneficiaries whose counseling is furnished by a qualified physician or other Medicare-recognized practitioner. As part of the benefit process, we recommend that CMS develop specific documentation and coding requirements for this benefit, to ensure appropriate utilization.

Evidence reviews performed by the United States Preventive Services Task Force (USPSTF), the leading independent panel of private-sector experts in prevention and primary care which is sponsored by the Agency for Healthcare Research and Quality (AHRQ), are considered the gold standard for clinical preventive services and our member organizations look to their recommendations as a key resource.

• The USPSTF's review and recommendation for counseling to prevent tobacco use and tobacco-caused disease recommendations, published in 2003 and amended in 2009, states that the USPSTF "recommends that clinicians ask all adults about tobacco use and provide tobacco cessation interventions for those who use tobacco products.

The USPSTF notes in its clinical summary that the intensity of counseling is important, and that multiple sessions are effective. Therefore, our members also support CMS's proposal to cover two individual tobacco cessation counseling attempts per year and each attempt may include a maximum of four intermediate or intensive sessions, with the total annual benefit thus covering up to eight sessions per Medicare beneficiary who uses tobacco.

In addition, if this NCD is approved and coverage for tobacco counseling is provided to all Medicare beneficiaries, CMS should review the three tobacco-related questions found within CAHPS Health Plan Survey for inclusion into the Medicare Health Outcomes Survey as well as (through AHRQ) the Medicare CAHPS Survey.

Thank you for the opportunity to provide these comments.

Sincerely,

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June 25, 2010

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

Re: Proposed Coverage Decision Memorandum for Counseling to Prevent Tobacco Use (CAG-00420N)

Dear Dr. Jacques:

The American College of Cardiology (ACC) is pleased to submit comments on the proposed national coverage decision for counseling to prevent tobacco use. The ACC is a professional medical society and teaching institution made up of 37,000 cardiovascular professionals from around the world – including 90 percent of practicing cardiologists in the United States and a growing number of registered nurses, clinical nurse specialists, nurse practitioners, physician assistants and clinical pharmacists. We appreciate the opportunity to provide comments on the evidence available regarding the appropriateness of providing counseling against the use of tobacco to Medicare beneficiaries.

Under current Medicare rules, coverage for tobacco cessation counseling services is only available to those who have been diagnosed with a condition that has been found by the U.S. Surgeon General to be associated with tobacco use or who are taking a medication that may be affected by such use. This policy deliberately excludes coverage for the provision of such services where the patient is a known user of tobacco but may not have been diagnosed with a tobacco-related illness at the present time, despite overwhelming evidence that smoking is a leading cause of some of the most common forms of cardiovascular disease, lung disease, and the most common types of cancer. The proposed coverage decision memorandum would rectify this error and potentially offer patients who smoke an opportunity to stop. The ACC strongly supports the proposal to expand coverage for counseling to prevent tobacco use to a previously uncovered population.

It has long been acknowledged that the benefits of smoking cessation are seen rapidly with respect to reductions in the risk of cardiovascular death. In fact, in a 2001 article from the Journal of the American College of Cardiology (JACC), the authors found that ex-smokers had a 30 percent lower mortality compared with current smokers, and these benefits were realized in patients suffering from heart failure within one-year’s time. Within three years, the risk was reduced to nearly that of non-smokers. Suskin N., et al. “Relationship of current and past smoking to mortality and morbidity in patients with left ventricular dysfunction. J. Am. Coll. Cardiol. 2001;37:1677-82. In an editorial comment from the same volume of JACC, the authors summarize Suskin et al. as demonstrating that “even in patients with established and serious cardiovascular disease, smoking cessation is an effective measure for the prevention of death and hospitalization.” Lightwood, J., et al. “Smoking cessation in heart failure: it is never too late.” 1683-1684. Given that prevention of both death and hospitalization are goals of the Medicare program, it would seem to be in the best interests of Medicare patients to cover all proven methods of assisting patients interested in ending their dependence upon tobacco.

According to the 2008 U.S. Surgeon General’s Clinical Practice Guideline on Treating Tobacco Use and Dependence, much progress has been made in the treatment of tobacco dependence in the last fifty years; however, there is still room for improvement. Medications and telephone quitlines have demonstrated themselves to be effective methods of addressing tobacco usage, but “there is a need for innovative and more effective counseling strategies.” Included in the key recommendations is that “[i]ndividual, group, and telephone counseling are effective, and their effectiveness increases with treatment intensity.” Coverage of such a benefit by the Medicare program would signal to other major health insurers and health benefits programs support for the evidence discussed in the report. Precedent suggests that others follow Medicare policies closely, so expanded coverage for tobacco cessation counseling by Medicare could potentially lead to increased coverage for it generally, thus creating the opportunity to reduce smoking levels and smoking-related cardiovascular deaths.

Given the voluminous evidence surrounding the implications of tobacco cessation counseling for cardiovascular disease, the ACC wholeheartedly supports the proposed expansion of Medicare coverage for this benefit. We look forward to working with CMS on this and future coverage issues. Please direct any questions or concerns to Lisa P. Goldstein at (202) 375-6527 or lgoldstein@acc.org.

Sincerely,

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Dear Sir/Madam:

The American Society of Health-System Pharmacists (ASHP) is pleased to submit written comments pertaining to the Proposed Decision Memo for Counseling to Prevent Tobacco Use (decision memo). For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society''s 35,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students.

ASHP discourages all use of tobacco products and supports evidence-based tobacco-control policies and activities that reduce the prevalence of tobacco use. ASHP commends the Centers for Medicare and Medicaid Services’ (CMS) proposal that counseling to prevent tobacco use for all adults and pregnant women who use tobacco is reasonable and necessary for prevention of illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. However, the Society is concerned that CMS proposes to cover tobacco cessation counseling for outpatient and hospitalized Medicare beneficiaries “whose counseling is furnished by a qualified physician or other Medicare-recognized practitioner,” thus excluding pharmacists.

ASHP has published a Therapeutic Position Statement on the Cessation of Tobacco Use (http://www.ashp.org/DocLibrary/BestPractices/TPSTobaccoCess.aspx), which includes information on nicotine pharmacology, health benefits of smoking cessation, strategies for promoting tobacco cessation, etc. All patients attempting to quit using tobacco should be encouraged to use effective pharmacotherapies for smoking cessation, except when medically contraindicated or in specific populations in which there is insufficient evidence of effectiveness. Further, ASHP believes that the active involvement of health care providers is crucial to effective tobacco control at the population level and that the pharmacy profession, as a primary and accessible point of contact between the health care system and the public, has a unique opportunity to serve as a cornerstone for the nation’s tobacco-control efforts. ASHP houses the National Pharmacy Partnership for Tobacco Cessation (NPPTC), a comprehensive national effort to provide pharmacists with the resources to empower smokers to stop their tobacco use. The NPPTC is funded by the Smoking Cessation Leadership Center and the Robert Wood Johnson Foundation, and an action plan was developed at the National Pharmacist''s Summit on Tobacco Cessation on October 21, 2004 in Bethesda, MD.

Additionally, Smith, et. al., described a nationwide program where pharmacists counseled patients on nicotine transdermal therapy for smoking cessation.1 The Pharmacists Educating Patients Program (PEPP) was designed to provide pharmacists the consultation resources for patients on nicotine transdermal therapy and to test the effectiveness of these pharmacists’ consultation services. More than 6,500 pharmacies and 40,220 patients participated in this program. One year after treatment began, a survey of 2,001 patients on nicotine transdermal therapy found that those who had not joined a comprehensive smoking cessation program (86.5%) but were counseled by a pharmacist had, a self-reported smoking cessation rate of 37% at the end of treatment, and 33% at an average of 10 months after treatment. Patients who participated in a comprehensive behavioral smoking cessation program, such as SmokEnders, and who also received counseling from their pharmacists (13.5% of surveyed patients) had a quit rate of 62% at the end of treatment and 45% after 10 months. Among surveyed patients, those who stopped smoking reported that their pharmacists'' counseling had been more intense and more helpful than the counseling reported by those who did not stop smoking. These results support the PEPP objective that pharmacists who counsel patients on nicotine transdermal therapy about smoking cessation can improve outcomes.

A study published by Dent, et. al., in 2004 described the long-term effectiveness of the program of an ongoing pharmacist-managed tobacco cessation clinic in the Veterans Health Administration (VHA) community-based outpatient clinic in Missoula, Montana.2 Clinical pharmacy specialists and pharmacy students provided tobacco cessation services for veterans, which included: a three-session program using the Trans-theoretical Model of Change, tobacco cessation pharmacotherapy, behavioral strategies, cognitive techniques, documentation in the health record, and a follow-up survey. Follow-up survey results were obtained for 130 (87.8%) of 148 veterans attending one or more sessions of the tobacco cessation class between November 1999 and December 2003. Of the veterans responding to the survey, 54 (41.5%) continued to be tobacco free. This result offers further evidence that pharmacists are effective providers of tobacco cessation services.

Pharmacists receive six years of training before earning their Pharm.D. degree, and often complete a residency in a specialized area. Pharmacists meet the primary care needs of patients by providing medication management and, in states where it is authorized, collaborative drug therapy management. Pharmacists should be treated the same as other Medicare-recognized practitioners, and should be able to use their expertise in providing tobacco cessation counseling for outpatient and hospitalized Medicare beneficiaries. ASHP strongly recommends that CMS provide Medicare coverage for cessation counseling services furnished by a pharmacist for individuals entitled to benefits under Part A or enrolled under Part B.

The Society appreciates this opportunity to provide comments. Please feel free to contact me if you have any questions. I can be reached by telephone at 301-664-8702, or by e-mail at jcoffey@ashp.org.

Sincerely,

Justine Coffey, JD, LLM
Director, Federal Regulatory Affairs

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June 24, 2010

Cindy Mann, JD
Deputy Administrator and Director
Center for Medicaid, CHIP and Survey & Certification
Centers for Medicare and Medicaid Services
7500 Security Boulevard, Room S2-26-12
Baltimore, Maryland 21244-1850

Dear Ms. Mann:

I am writing to share with you Washington State's comments on the Proposed Decision Memo for Counsel ing to Prevent Tobacco Use (CAG-00420N). The Washington State Department of Health supports permitting states to obtain federal Medicaid matching funds for the cost of tobacco cessation services provided by quitlines. All tobacco users in the United States should have access to evidence-based, barrier-free tobacco cessation medications and behavioral counseling. We support expansion of Medicare counseling to all recipients.

The US Public Health Service Guideline: Treating Tobacco Use and Dependence recommends that all clinicians identify tobacco users, complete brief interventions, prescribe medication, and refer them for more intensive counseling. Barriers to getting tobacco users the help they need as they try to quit include:

• A lack of covered medications;
• A maze of restrictions and exclusions where coverage exists; and
• A lack of adequate reimbursement for counseling.

Expanding the Medicare counseling benefit to all recipients is one important step to reduce these barriers and the heavy cost of tobacco use to society and individuals. In addition, we recommend the following changes to further reduce tobacco cessation barriers and improve the Medicare tobacco cessation benefit:

• Include over-the counter medication in the Medicare benefit. It is unlikely that the Centers for Medicare and Medicaid Services (CMS) will fully realize the health and economic benefits of reductions in tobacco use if seniors do not have ready-access to selfadministered free or low-cost over-the-counter medications.
• Expand the definition of qualified providers to increase access to brief and more intensive interventions. Currently the only providers eligible to bill Medicare directly for cessation counseling are physicians, other prescribing providers, hospitals, clinical psychologists/psychiatrists, and occupational therapists. This change is impOliant since providers like respiratory therapists, registered nurses, chemical dependency counselors, social workers, and health educators are increasingly likely to share responsibility for tobacco interventions with overburdened physicians.
• Revisit the exclusion of tobacco cessation quitlines and the limitation on counseling sessions to four per quit attempt. Since tobacco dependence treatment groups typically run for six to eight weeks, an alternative could include increasing counseling sessions to six per attempt, or up to eight counseling sessions per year.

Please contact Paul Davis, Policy Specialist, Tobacco Prevention and Control Program at (360) 236-3642 if you have any questions. Thank you for the 0ppoliunity to comment on this important change.

Sincerely,

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Dear Sir/Madam:

This comment is submitted by Free & Clear, Inc. to the Centers for Medicare and Medicaid Services (CMS) in response to the proposed Decision Memo to Prevent Tobacco Use (CAG-00420N) (the “Decision Memo”).

The Decision Memo specifies that tobacco cessation counseling delivered to Medicare beneficiaries will be reimbursable when provided by a “qualified physician or other Medicare- recognized practitioner.” We urge CMS to define “Medicare -recognized practitioner” to include the well-established tobacco cessation “quitlines” currently administered by each of the 50 US states, two territories, and the District of Columbia.

Quitlines staffed by trained tobacco cessation professionals have served over the past decade as the front line in providing efficient and effective evidence-based tobacco cessation counseling services to U.S. citizens. Linked in a national network via a toll free number, 1-800 QUIT NOW, quitlines are required to meet high performance standards for employee training, quality assurance, support for special populations, hours of operation, and service results. Quitlines have demonstrated excellent quit outcomes and satisfaction rates as validated by randomized control trials and independent evaluations. The DHHS Clinical Practice Guideline for Treating Tobacco Use and Dependence declared in 2008 that “quitlines have been shown to be effective in providing wide access to evidence-based cessation counseling.” According to best practices developed by the Centers for Disease Control and Prevention, sustaining, expanding, and promoting quitline services should be a key component of tobacco control programs. The Decision Memo itself encourages health care providers to promote state quitline use because it is “effective with diverse populations and has broad reach.”

Over nine percent of Medicare beneficiaries use tobacco and tobacco-related illnesses account for over $27 billion dollars in Medicare expenditures. Quitlines could help improve these results materially, particularly given that older quitline participants are typically more engaged and achieve higher quit rates than younger participants. Unfortunately, Medicare beneficiaries have represented less than five percent of quitline participants and recent studies indicate that most health care professionals within primary health care settings are not proactive in counseling smokers around cessation even when the opportunity is presented. Thus, by treating quitlines as Medicare recognized practitioners, CMS has an extraordinary opportunity to improve the health of many Medicare beneficiaries who would othwerwise be likely to continue tobacco use.

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Re: Proposed Coverage Decision Memorandum for Counseling to Prevent Tobacco Use (CAG-00420N)

As President of the American College of Chest Physicians (ACCP), I am writing on behalf of the ACCP membership. ACCP is comprised of over 17,500 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, sleep medicine, and anesthesiology. These health care professionals practice in virtually every hospital in this 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, critical care medicine, and surgery. We appreciate the opportunity to submit comments relative to the Proposed Coverage Decision Memorandum for Counseling to Prevent Tobacco Use.

We strongly support the Centers for Medicare and Medicaid Services (CMS) proposal to cover tobacco dependence counseling for outpatient and hospitalized Medicare beneficiaries, as well as pregnant women, regardless of whether these patients exhibit signs and symptoms of tobacco related disease.

Whether our patients exhibit tobacco related diseases or are asymptomatic, we see the long-term impact of tobacco usage. With tobacco dependence recognized as a chronic medical condition, it is critically important that all clinicians be encourage to treat this disease just as they would treat other chronic conditions. This means that patients should be counseled, encouraged to participate in a treatment protocol, managed and, of equal importance…followed. Studies show that when physicians just talk to their patients about tobacco dependence, the patients have a moderately successful outcome.

We agree with the recommendation of the U.S. Preventative Services Task Force, that with more in depth counseling supported by CMS through coverage of two individual tobacco counseling attempts per year for longer periods of time, there would be a high certainty that net benefits would be substantial.

With tobacco use, still the leading cause of preventable death and chronic illness in this country, the ACCP strongly supports your recommendation to expand tobacco dependence counseling to Medicare beneficiaries, and pregnant women, whether they currently exhibit tobacco related illnesses.

Sincerely,
Kalpalatha K. Guntupalli, MD, FCCP
President
American College of Chest Physicians

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I urge CMS to approve counseling ALL adults about tobacco use and offering treatment to asymptomatic tobacco users. Lack of symptoms does not equal lack tobacco harm. Tobacco use is the most prevalent cause of preventable death and disease in ths U.S. and waiting until harm is evident not only harms the patient but is also the LEAST cost effective way to manage health. The need for prudent use of health care dollars demands we treat tobacco dependence disease in the early, asymptomatic stage to prevent the far more costly and devastating late stage symptoms such as CAD, COPD, and cancers.

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The proposed CMS update on tobacco cessation counseling could carry a significant impact towards improved smoking cessation rates and overall health in this country. Smoking is a leading risk factor for diseases such as COPD, lung cancer, stroke and cardiovascular disease. All these disease processes carry significant morbidity and mortality. In addition, the annual health care costs associated with these diseases is substantial. There is clear data that face to face physician-patient discussions on smoking cessation improve the rate of smoking cessation. In addition, the National Preventative Task Force has given a grade A recommendation to smoking cessation counseling for asymptomatic smokers. If the health care community could improve the rate of smoking cessation, the morbidity, mortality, and cost burden to the health care system could be reduced.

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I strongly support the Centers for Medicare and Medicaids proposed decision to provide physician-based tobacco cessation counseling. As someone who has worked for the past two decades addressing the harms caused by tobacco, I believe that all medical professionals should be offering cessation advice but especially to pregnant women and Medicare beneficiaries. The benefits to the individuals are huge and the cost savings are enormous. Half of all individuals who use tobacco products die as a result of their tobacco use. Disease, disability, cardiovascular complications and exascerbations of many co-morbid conditions are the price we all pay for continued tobacco use. If we can send a message that tobacco use can improve the quality of lives by covering physician-led cessation counseling, it would be a step in the right direction.I applaud this decision.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. It is my position that this policy will help many tobacco users break free from a deadly behavior, people who otherwise would have been unable to do so. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

Not only is tobacco cessation counseling a Grade A rated recommendation by the U.S. Preventive Services Task Force, it is also received the highest ranking by Partnership for Prevention''s National Commission on Prevention Priorities. In that review, physician tobacco cessation counseling was one of only three clinical preventive services to receive the highest score for cost and prevention effectiveness.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries.

Tobacco cessation counseling has been evlauated as a Grade A rated recommendation by the U.S. Preventive Services Task Force and is recommended by the Department of Health and Human Services Clinical Practice Guideline on Treating Tobacco Use and Dependence with good evidnece of the effectiveness of the strategy.

I urge the CMS to move forward with this important public health measure. It is critical for the health of Medicare beneficiaries to have this service provided. I work at Intermountain Healthcare in Utah and have done the cost modeling for our insured population and for our state around tobbacco cessation services. It is a cost effective strategy for society and for any health care insurer, including CMS, to invest in tobacco cessation counseling and treatment.

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The American Association for Respiratory Care (AARC) is pleased to comment on CMS’ proposed decision to extend tobacco cessation counseling for outpatient and hospitalized Medicare beneficiaries who use tobacco regardless of whether the beneficiary has signs and symptoms of tobacco-related disease. The AARC is a national professional association representing 50,000 respiratory therapists nationwide.

Respiratory therapists who provide smoking cessation counseling to their patients with chronic conditions such as asthma and chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis, see first hand the devastating effects of smoking and the associated illnesses that result from long-term use. That is why we wholeheartedly support CMS’ decision to add this valuable tool as a preventive measure for asymtomatic Medicare beneficiaries who use tobacco. Not only does the benefit offer cost savings to the Medicare program, it has the potential to prevent deaths from tobacco-related diseases.

We commend CMS in its decision to expand the coverage criteria. Since the hospital readmission rates for COPD and pneumonia, for example, represent a significant cost to the Medicare program, any action to prevent an increase in tobacco-related diseases can only represent a positive outcome for both the beneficiary and Medicare.

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Dear CMS,
Thanks for considering this very important topic of reimburesment for medicare and medicaid patients. As a chaplain for a 325 bed hospital, I am confronted daily with persons who are unable to afford utilities, food for their families and money for medications. With dwindling community resources I have struggled to come up with realisistic creative ways to help people find the money they need in order to live healthier lives. Sadly, when these families ask for money, they are usually smoking anywhere from 1-2 packs of cigarettes per day. That number increases as you consider the rest of the family members and friends in the household who are smoking. This is not to mention that in SW Louisiana we have one of the highest SIDS rates in the country which is related to second hand and third hand smoke. Not only a tragedy, but a huge overall healthcare/hospital expense in and of itself). I starting adding up the amount of money that some of these families were spending and was amazed at how much money could possibly be available to families and individuals if they were offerred intensive smoking cessation. I had an opportunity to receive certification as a Tobacco Treatment Speacialist from the University of Mississppi Medical Center. I have been offering counceling for free. These are usually one hour group session. The Auxilians purchased a CO monitor for me. The nice thing about a multdisiplined program in which a trained specialist works with the patients and thier primary physician, is that the patient feels very cared for and very safe. I don''t know exactly how you are planning to break down a pay out, whether it''s to a physician or a specialist. I can tell you. One physician spoke to me and he feels like the brief counseling (3 min or less)..."here''s your medication," isn''t much more effective than the 15 minute session. There just isn''t enough time to get into the depth of the nature of the substance abuse and address cognitive behavioral approaches/stateges to help patients learn new behaviors other than smoking. I personally don''t care if I make any money off of something like this. I would rather put the money in a foundation and help the poor. But if CTTS persons could be added in to the payment scale somehow, it would dramatically increase points of access at which persons of low(er)income could participate in an evidence based smoking cessasation program that would not only improve their health, but improve their financial status as well.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. Many lives will be extended and much money saved if this decision is enacted.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about.

It is important that the CMS hears from constituents who support disease prevention, health promotion, and tobacco cessation. If enacted, this measure represents a lifesaving advance in our capacity to guarantee that all tobacco users have access to evidence-based tobacco cessation counseling. A significant public health benefit will be realized.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. It is Partnership for Prevention''s position that this policy will help many tobacco users break free from a deadly behavior, people who otherwise would have been unable to do so. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

Not only is tobacco cessation counseling a Grade A rated recommendation by the U.S. Preventive Services Task Force, it has also received the highest ranking by Partnership for Prevention''s National Commission on Prevention Priorities. In that review, physician tobacco cessation counseling was one of only three clinical preventive services to receive the highest score for cost and prevention effectiveness.

I urge CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about.

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Counseling to prevent tobacco use is something that many physicians do constantly, taking advantage of situations in which the tobacco use is more applicable or directly related to the the patient''s clinical problem. A problem that I see is how to document the extent of the counseling and its quality and effectiveness. Adherence to a set of guidelines for couseling is essential.I am sure that if this is worked out to the agreement of CMS and medical societies, many physicians will become more involved. As a surgeon one may have an advantage in the effect of counseling, as usually a tobacco related problem prompts the patient''s visit. Although the effect of counseling may not be as strong during a routine medical visit, this is done much more often and would be useful even with a lower response rate. I will be using the Toolkit provided by the ACCP for its members.

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Evidence-based tobacco cessation counseling and nicotine replacement treatments (NRT) should be included and strengthen in insurance coverage to assist tobacco users in quitting. Intervention will help reduce the likelihood of a medical condition worsening and becoming more costly. Tobacco users will use helplines or quitlines if nicotine replacement treatments are offered to assist them in quitting. Health Departments can work with quitlines to offer counseling and nicotine replacement treatments however Health Departments have a very small budget for NRT. Clients drop off from the quitlines when Health Departments no longer have money for free NRT. Doctors, nurses, WIC staff, and substance abuse counselors need to be trained on evidence-based tobacco cessation counseling (5A’s Counseling) to help reinforce the importance of quitting tobacco and the benefits of a smoke free environment.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries.May I further urge:

1. Use of the term "tobacco treatment" vs. "tobacco cessation..". Tobacco dependence is a chronic condition, such as alcoholism. We do not promote or provide "Alcohol cessation counseling".

2. I urge coverage of these services as provided by a physician, nurse practicioner, physician assistant and/or other licensed healtcare provider.thank you.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. It is the Oklahoma Tobacco Settlement Endowment Trust''s position that this policy will help many tobacco users, particularly those who have suffered from tobacco addiction and tobacco caused diseses for much of their adult lives. This benefit will no doubt extend life, enhance quality of life, and save money.

TSET urges CMS to pursue with this essential public health measure. It is critical that all Medicare beneficiaries have access to this evidence-based treatment. Extending this benefit to those who have not yet experienced tobacco-caused illnesses will hold the best opportunity to save lives and save money.

In addition I would like to take this opportunity to urge CMS to cover quitline services. Quitlines have been proven effective as population-based tobacco dependce treatment by the U.S. Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence. Quitlines are highly cost effective, and can play a critical role in treating tobacco use and reducing tobacco-caused disseases.

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I wholeheartedly endorse covering all Medicare recipients for tobacco cessation by an approved Medicare provider. This is the most intelligent path to promote tobacco cessation and disease prevention. Evidence supports counseling as effective. As policy makers move away from health crises management into disease prevention the Medicare program stands to save dollars spent on COPD and lung cancer. Please make the logical vote for wellness by extending tobacco cessation counseling for ALL Medicare recipients.

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I strongly support the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. It is Partnership for Prevention''s position that this policy will help many tobacco users break free from a deadly behavior, people who otherwise would have been unable to do so. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

Not only is tobacco cessation counseling a Grade A rated recommendation by the U.S. Preventive Services Task Force, it is also received the highest ranking by Partnership for Prevention''s National Commission on Prevention Priorities. In that review, physician tobacco cessation counseling was one of only three clinical preventive services to receive the highest score for cost and prevention effectiveness.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about.

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It is imperitive that we, as pulmonologists, strive to intervene whenever we can to encourage discontinuation of smoking in ANY patient. However, it is even MORE significant in the pregnant patient (two lives are involved!),and the patient without identifiable clinical symptoms.Interventions with these populations of patients give us a chance to SAVE and PROLONG lives, and PREVENT disease.This should be a MAJOR goal for all physicians. Payment coverage for the time-consuming counseling that it takes with an ADDICTION issue is very appropriate.Your consideration is appreciated.

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I applaud you and give my strongest support forthe Centers for Medicare and Medicaid Servicesproposed decision to extend tobacco cessationcounseling to all Medicare recipients. This policywill help many tobacco users quit using tobacco,people who otherwise would not be able to do so.Providing counseling for all is cost saving, willhelp save lives, and improve quality of life.

Tobacco cessation counseling is a Grade A ratedrecommendation by the U.S. Preventive ServicesTask Force. Studies show that physician tobaccocessation counseling is one of three clinicalpreventive services to receive the highest scorefor cost and prevention effectiveness.

I thank the CMS for their consideration of thiscritical public health measure and their movetoward prevention. All Medicare recipients deservethe benefits of having full access to counseling,and not just those who were diagnosed withtobacco-related illnesses. I look forward tohearing about your final determination on this issue.

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It seems obvious to me, as a pulmonologists who treats the end effects of tobacco smoking, that the counseling to prevent tobacco abuse should be included as a reimbursible activity. While the quit rate for patients counseled remains low, studies show it is double the rate of non-counseled patients. Because it is a major cause of many otherwise preventable diseases, tobacco is a huge cost burden to society. A burden which would be lessened if more individuals could be convinced to discontinue it use. I suspect that the ultimate monetary benefit by reimbursement would far outweigh the cost. Certainly the societal benefit would be enormous.

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Please include asymptomatic smokers in the list of covered Medicare patients for tobacco dependence coverage. As someone working in the trenches on a daily basis and having treated over 1,000 tobacco users in the quitting process, I can say that lack of coverage is the biggest barrier to attendance. These services are so cost effective and will reduce health care costs in the short and long term, in addtion to saving lives. Also, they are recommended with a grade A recommendation of the US Preventative Services Task Force.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. It is Partnership for Prevention''s position that this policy will help many tobacco users break free from a deadly behavior, people who otherwise would have been unable to do so. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about.

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I have worked with the Mental Health/Behavioral Health population for 30 years. It is shocking the tobacco use and devastation caused by tobacco. This population has a 10 to 15 year reduction in life expectancy and I believe tobacco use is the major contributor to their reduced life expectancy. Counseling and education have been shown to be effective in curbing tobacco use. Waiting until someone has a tobacco related illness to provide counseling is akin to waiting until the horse is out of the barn to close the door. Tobacco reduction counseling must be directed toward all tobacco users in order to preserve lives and to impact the costs of tobacco related illnesses. The time is now to move ahead with this initiative and benefit.

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I strongly support a new NCD to help pay for time spent counseling patients re: smoking injury and cessation. It DOES take time, and it DOES help stiffen the spine of patients who want to quit anyway.

As a specialist in lung diseases for more than forty years, I have personally helped dozens of patients accomplish what they had tried without success: QUIT SMOKING. Strong evidence shows that when a trusted physician urges smoking cessation, the odds of quitting double.

I know of no more powerful way to cut future costs than to help PREVENT the future Xrays, lung function tests, medications, oxygen therapy, hospital visits, intensive care support, pulmonary rehabilitation, loss of work, and simple individual agony from decades of survival with debilitating shortness of breath.

Please help me pay for the time costs of asking each new patient (as I have done for decades) about smoking, and helping them QUIT.

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I am writing to express my STRONG support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. This policy will help many tobacco users break free from a deadly addiction, people who otherwise would have been unable to do so. Undoubtedly, many lives will be extended and MUCH money saved if this decision is enacted.

Medicare has significantly lagged behind in this area. This adoption of evidence-based standards will bring Medicare up to the same high level as other health payors, including Medicaid.

Not only is tobacco cessation counseling a Grade A rated recommendation by the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention, it is also received the highest ranking by Partnership for Prevention''s National Commission on Prevention Priorities. In that review, physician tobacco cessation counseling was one of only three clinical preventive services to receive the highest score for cost and prevention effectiveness.

Tobacco use is the single most reversable disease prevention strategy we have. Prevention has already saved hundreds of thousands of lives but we still have so much more to do to counter the aggressive tactics of the tobacco companies to keep people using tobacco. I have been working in the area of tobacco use prevention for over 10 years and in the health and mental health fields for over 30 years. I see the effectivness of the evidence-based standard being used. And I have seen the ravages of tobacco use professionally and personally with friends and family.

I STGRONGLY urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about.

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Enabling physicians to offer tobacco cessationcounseling as a tool to address tobacco addictionis an important investment in national health thatwe can no longer afford to ignore. As such, Istrongly urge CMS to consider coverage forCounseling to Prevent Tobacco Use.

Tobacco use, particularly smoking tobacco, carriesa significant cost to the United States throughits contribution to national health care spendingand lost productivity. Social incentives for anindividual to start smoking are supported throughsignificant investments in cigarette marketing bymanufacturers. Smoking is then more costeffectively sustained by the addictive drugNicotine; found in varying quantities incigarettes with dosing regulated by manufacturers.

Social factors affect an individual''s choice tobegin smoking, often at a young age. The healthof an individual is significantly impacted by thechoices that lead to a smoking habit. Physicianshave a responsibility to improve the health of anindividual. Although replacement therapies,dopaminergics and other pharmacological agents canbe prescribed by physicians to decrease the effectof cigarette delivered nicotine as a contributorto a smoker''s habit, without counseling the socialfactors associated with smoking still remain.

Physicians'' ability to address the social factorsassociated with an individual''s smoking habit islimited due to practice constraints. Financialincentives such as coding and coverage of tobaccocessation counseling for Pulmonologists treatingthe sequelae of smoking, would allow foradjustments in practice patterns to accommodatethis important treatment. Also more importantly,the US Preventive Services Task Force indicatesthat there is a high certainty that the netbenefit of providing tobacco cessation counselingto asymptomatic smokers is substantial.

Having personally developed several public healthprograms to address smoking habits in conjunctionwith Harvard Medical School and Dartmouth MedicalSchool, I can recognize the multitude of patientsthat would benefit from physician tobaccocessation counseling. Many of the public healthprograms we develop are effective in inspiringindividuals to quit smoking but leave them shortof the proper physician counseling supportservices required for their success.

As a member of the American College of ChestPhysicians, my colleagues and I are continuallydedicated to improving national health throughaddressing the health of patients. I stronglyurge CMS to support coverage of smoking cessationcounseling for physicians. It is an importantaspect of public health, and an important strategyfor reduction of national health care spending andimproving national productivity.

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries.

Individuals who experience severe and persistant mental illness are the largest consumers of tobacco products in the U.S. In addition, research published in JAMA demonstrates people reporting a mental disorder in the past month consumed approx. 44.3% of all cigarettes smoked in the U.S.

Individuals who experience mental illness are predominately recipients of Medicaid and Medicare. They are the most vulnerable of Americans, an at-risk population with low-economic status, high unemployment, and of low health literacy. Research demonstrates that they also receive lower quality of care than their peers and are less likely to receive counseling on tobacco cessation.

SAMHSA studies are currently focused on the "10 x 10 Campaign," a campaign to educate the public about and reduce the impact of the fact that individuals who experience severe and persistant mental illness have a statistical likelyhood of dying 25 years earlier than their peers due to several preventable factors, which includes tobacco usage.

Access to medically-supported tobacco cessation programs is fundamental to addressing this crisis.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness.

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It is essential to be able to spend time on patients who are smokers to help them quit even BEFORE they have problems such as a heart attack, longstanding cough, worsening asthma and so forth. Prevention of these costly diseases is much more cost-effective than treating them. In the end, they will have to be counselled to quit. Why not support the effort early, rather than wait for disaster?

To do counselling effectively, significant time must be spent with the patient. This time must be reimbursed or it''s simply not going to be done effectively. Numerous studies show that a medical provider''s counselling is the most important factor in getting patients to quit. It''s time and money well-spent.

Thank you.

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I am very encouraged by CMS’s consideration of expanding tobacco dependency treatment.

I work a peer wellness coordinator with persons that have mental illness. An astounding 44% of the tobacco market is comprised of my peers who have mental health diagnoses. Persons with mental illness are dying at a rate of at least 25 years earlier than the general population, and in the case of persons with both mental illness and substance abuse issues, the death rate is as high as 38 years of life lost, meaning an average age of death being 45 years of age. (Measuring Premature Mortality Among Oregonians, Oregon Department of Human Services, 2008)

Tobacco use is one of the biggest contributors to the high morbidity and premature death rate. I have seen too many persons who are friends and peers die early deaths because of their lifestyles, especially their use of tobacco products.I am outraged by the tobacco industry’s marketing of its products to this health disparity population. The proposed CMS support to persons who need treatment for nicotine addiction will help vulnerable people get some needed help. If these persons do not receive help before they develop tobacco related illnesses, they will often go without care and end up being treated at a later stage of illness, often in Emergency Departments. Of course, this is not cost effective and it is terrible waste of persons’ lives. By offering early stage care, we will save lives and also be doing what is cost effective. It is a win-win strategy.

Thank you for this opportunity to comment and for the thinking that CMS is doing towards early intervention and preventative measures.

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It is my understanding that CMS is evaluating its policy regarding the payment for counseling to prevent tobacco use.

The proposal looks at counseling to prevent tobacco use for all adults and pregnant women who use tobacco regardless of whether the patient has signs and symptoms of tobacco-related disease.

Coverage is proposed for outpatient and hospitalized Medicare beneficiaries who are competent and alert at the time of counseling.

I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. Such treatment will help many nicotine dependent individual to free themselves from a deadly addiction to tobacco. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

I hope CMS will move forward with this critical public health measure quickly. The entire Medicare community are affected by tobacco use and deserve to benefit from this service, not just those who have been diagnosed with a tobacco related illness. After all, the prevention of disease is far less costly than the burden of disease.

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As a pulmonary doctor, with more than 30 years of experiencie, I could tell you a few devastating human and family tragedies caused by smoking. I see them on a daily basis. There is no question tobacco smoking is the number 1 public health enemy. We, as society need to do everything possible to stop persons (especially children and teenagers) from ever start smoking. Second best, we need to have all the help and incentives to help smokers quit. Paying for the time and effort involved in helping patients quit is both fair and effective, money-saving in the long run.

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The Society for Public Health Education (SOPHE) strongly supports the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries, not just those affected by tobacco-related illness.

Effective interventions for tobacco cessation not only include culturally and linguistically competent counseling, but also the provision of social support and nicotine replacement devices or medication for some individuals. SOPHE urges CMS to support not only the two individual tobacco cessation counseling attempts per year as in the proposed rule (CAG-00420N) but also other effective, provider-approved cessation services.

Tobacco use is the single most preventable cause of disease, disability, and death in the United States. Each year, an estimated 443,000 people die prematurely from smoking or exposure to secondhand smoke. SOPHE urges CMS to adopt this rule quickly to prevent these avoidable deaths.

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The Alliance for the Prevention and Treatment of Nicotine Addiction would like to express strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. There is no safe level of tobacco use and many people who would like to quit need assistance.

Tobacco use cessation is a needed and necessary public health goal. Cessation counseling is achievable, cost-effective and clinically effective. It has been identified as a priority intervention in the U.S. Preventive Services Task Force recommendations and has the capacity to save lives and reduce healthcare costs.

It is important that CMS move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, including those who can be helped earlier and reduce or prevent unnecessary suffering from tobacco-caused diseases.

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I support the Centers for Medicare and MedicaidServices proposed decision to extend tobaccocessation counseling to all Medicarebeneficiaries. Studies have shown that medication,in combination with behavioral counseling, canincrease the odds of quitting successfully. Whenpeople quit, they gain major and immediate healthbenefits.

Private sector employers are increasinglyproviding smoking cessation benefits which helptheir respective company’s bottom line. Employeeswho smoke are more costly than non-smokers. Eachadult smoker costs employers $3,700 annually inlost productivity and excess medical expendituresdue to all smoking-related illnesses. The cost ofproviding a comprehensive tobacco cessationbenefit is between just 10 and 40 cents per memberper month.

Tobacco cessation is more cost-effective thanother common and covered disease preventioninterventions, such as the treatment ofhypertension and high blood cholesterol accordingto the CDC. Tobacco-use screening and briefintervention was ranked among the top threehighest-ranking preventive services available interms of public health benefit andcost-effectiveness, yet was the least utilized ofall preventive services, with only 35 percent ofsmokers receiving U.S. Preventive Services TaskForce (USPSTF) recommended interventions.

Garry M. Lindsay

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I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness.

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Providing reimbursement for smoking cessation counseling for all smokers would be a huge step forward for our country. As a pulmonary/critical care physician I see the negative health effects of smoking every day. We spend (and CMS pays) thousands of dollars per day in the ICU to treat people with smoking related illnesses but we cannot or will not pay to counsel people to quit - that is a crazy policy that needs to end. It is no wonder we spend more on health care per person than any other country but have relatively poor health outcomes. Smoking cessation does not work for everyone but it is very cost effective and reimbursement for it (for every smoker) is long overdue.

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Given the extent of morbidity, and poor outcomes associated with continued tobacco smoking, more intensive counseling and follow-up makes medical and economic sense. I think it is imperative that CMS consider other levels of providers who can be trained to treat tobacco dependence to be eligible for reimbursement. Tobacco dependence treatment specialists are available and can provide treatment - including follow-up more cost efficiently. this should not preclude currently eliglible providers from providing service. But specialists can help build capacity by providing treatment directly, helping system changes to better address tobacco dependence, and as a resource to primary providers.

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This is a very cost effective measure which seems to be the code phrase for the 21st century. Spending $20-50 to counsel someone to quit smoking will not only make people happier later on when they don''t have to suffer the effects of COPD, MI and stroke, but also will save hundreds of thousand of dollars per person in medication and health care costs. One week stay in the ICU for a COPD excaerbation can cost 40-50,000 dollars. This smoking cessation counseling is a win win for everyone involved including Medicare.

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In my practice, I have frequently found patients who are smokers who are having thoughts about quitting, but need the weight of counselling from their physician, as well as the resources available through prescription medications, to help firm their resolve. This is a critical service that physicians should be providing to all smokers who are interested, regardless of whether they have started to experience complications of their smoking yet. Physicians need to be fairly compensated for this additional task. The future cost savings are substantial, and it is the right thing to do.

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Traditionally, physicians do not consider spirometic measures abnormal unless they are statistically below the 95% confidence limits. However, it is reasonable to counsel smokers who are below the normal mean values for their age and gender by informing them of their lung age. This is easily calculated. For every one percent their ratio of one-second to total vital capacity (FEV1/FVC) is below mean predicted, their lung age is increased by 3 years!! Lung age can increase as much as 20 or more years and still be considered "normal" by traditional standards! Making this simple measure and informing smokers of their lung age (usually higher than their actual age)should help persuade them to get counseling or therapy to increase their health and longevity. See European Resp Journal in press.

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As a Registered Respiratory Therapist I havebeen concerned for more than 30 years of themedical and financial costs of tobacco usage. Inparticular, I have personally seen thousands ofpremature deaths in persons who smoke and/orexposed to Second-Hand Smoke. These deaths areoften preceded by years of cardio-respiratorydiseases.

The economic burden of caring for chronic lungand heart diseases, and their frequentexacerbations, is particularly worrisome. We havehad, for too long of a time, a health system thathas ineffectively reduced these diseasesoccurrence and costs. You, the CMS, willobviously know better than I do, how manybillions, with a "Big B", are spent managing thisineffective and inefficient approach.

As indicated in my opening remarks, I havepracticed Respiratory Therapy for a long time. During this period, I have tried, my best, toencourage patients to cease smoking. I haveassisted them in Better Breathing Clubs and otherforums. Prevention and Education are bothcritical to alleviating the morbidity andmortality resulting from tobacco usage.

I am encouraging the CMS to adopt a feepayment for all levels of interaction from Basicto Advanced. Physicians, particularly, chestphysicians and respiratory therapists, workingunder medical direction or indirect supervision,as determined by CMS, be reimbursed for thesmoking cessation intervention, provided in bothan inpatient and outpatient setting.

Smoking does not produce clinical changes, asmanifested by patients with chronic lung and heartdiseases, for several years. No one is actuallysymptom free even after smoking a year, or forthat matter after a single cigarette. Blood oxygenlevels are decreased by as much as 15 percentafter a "few smokes". The oxygen deprivationstresses the human anatomy and physiology.

It makes excellent medical and economic sense,to provide the educational interventions, I speakof, for ALL SMOKERS, symptom free or not. Eachcigarette smoked may not singly be readilyapparent as harmful. One cigarette begets the nextand so forth. The chain of events occurs afterthat first cigarette and is excessively costly.

Let us all reverse the the deadly and costlytrends of cardio-respiratory disease. I supportreimbursement of smoking education for all smokers.

Thank you. I remain,

Raymond B. Sheely, RRT

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Being a consultant to the American College of Chest Physicians (ACCP) and the American Thoracic Society (ATS)on coding and reimbursement issues, I would like to personally comment and support the CMS proposal to support smoking cessation counseling to prevent tobacco use for all adults and pregnant women who use tobacco regardless of whether the patient has signs and symptoms of tobacco-related disease. I encourage pulmonologists and their staff on being aware of the smoking cessation counseling benefit. I would also suggest that pediatric pulmonologists who provide smoking cessation counseling to children and adolescents and their smoking parents also be able to report CPT 99406, 99407 and be able to be paid for the counseling service. Additionally, ACCP has just made its Tobacco Dependence Treatment Toolkit available to its membership for free until August 31, 2010 available at its website http://tobaccodependence.chestnet.org/sales-page This is what ACCP said: The ACCP Health and Science Policy Committee has developed an evidence-based, comprehensive, user-friendly online tool kit to help you help your patients to stop using tobacco safely and comfortably. The ACCP Tobacco Dependence Treatment Toolkit is free and now available online for all ACCP members. Now through August 31, 2010, obtain your free access to this tool kit. Having my MPH since 1975 and having quit smoking on June 3, 1980, puts me in a unique position to seek Medicare and Medicaid support of smoking cessation counseling for all Americans. I did not have access to such information when I smoked. The ATS guidelines on treatment of tobacco use are found at http://www.thoracic.org/education/career-development/residents/ats-reading-list/smoking-cessation.phpThe US Preventive Services Task Force states with a high certainty that the net benefit of providing tobacco cessation counseling to asymptomatic smokers is substantial. So I applaud your recommendation for adults and pregnant women; however, I would also include those children and adolescents who smoke or use other forms of tobacco, into your policy. Prevention rather than the early end-of-life patients that pulmonologists deal with on a daily basis would be a solution and save substantial dollars rather than dealing with all the variations of COPD and other tobacco-related deaths due to lifestyle choices of smoking and tobacco use as the boomers (and I am one of them) move toward the end of our life. Diane Krier-Morrow

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Tobacco Dependence is a common disease that leads to substantial morbidity and mortality in both the smoker and individuals close to him or her (via second hand smoke exposure). Effective treatments for tobacco dependence are available but grossly underused (see the Fiore et al Guidelines). There is no other severe fatal illness that we routinely fail to offer effective treatment on. There are few other medical treatments that can yeild as substantial a long term health benefit as effective tobacco dependence treament.

It is imperative that effective tobacco dependence counseilng and treatment be a covered benefit, regardless of whether the patient has over tobacco related disease (yet).

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To Whom it may Concern,

I am writing to express my strong support for the Centers for Medicare and Medicaid Services proposed decision to extend tobacco cessation counseling to all Medicare beneficiaries. It is Partnership for Prevention''s position that this policy will help many tobacco users break free from a deadly behavior who otherwise would have been unable to do so. Undoubtedly, many lives will be extended and much money saved if this decision is enacted.

Not only is tobacco cessation counseling a Grade A rated recommendation by the U.S. Preventive Services Task Force, it is also received the highest ranking by Partnership''s National Commission on Prevention Priorities. In that review, physician tobacco cessation counseling was one of only three clinical preventive services to receive a high score of ten for cost and prevention effectiveness.

I urge the CMS to move forward with this critical public health measure when the public comment period has concluded. The entire Medicare community deserves to benefit from this service, not only those who have been diagnosed with a tobacco related illness. After all, that''s what prevention is all about.Respectfully,

David Zauche
Senior Program Officer
Partnership for Prevention

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I believe CMS should reimburse for counseling to prevent tobacco use for all adults, including pregnant women who use tobacco regardless of whether the patient has signs and symptoms of tobacco related disease. Just talking with your physician regarding tobacco use has a moderate success rate for quitting. All users can be helped to stop their dependence but they cannot all succeed on their own. Tobacco is one of the most costly (financially and otherwise, including health status, time lost to work or school, etc) medical conditions. Tobacco dependence is a chronic medical condition and should be treated as such by physicians and other healthcare providers. Using the new Tobacco Dependence Treatment Tool Kit, by the American College of Chest Physicians, providers can learn evidence-based techniques that have proven track records to help physicians nurses, and cessation counselors help their patients stop using tobacco in a comfortable and successful manner. CMS should promote the providers'' efforts to help their patients as this is a win-win, with long-term consequences and costs ultimately being reduced.

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