ACP: Governmental Affairs and Public Policy - ACP Urges CMS to Make a National Coverage Determination that Tobacco Cessation Counseling is a Covered Service Under Medicare

Advocacy

ACP Urges CMS to Make a National Coverage Determination that Tobacco Cessation Counseling is a Covered Service Under Medicare

July 23, 2004

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

RE: National Coverage Determination Request for Smoking and Tobacco Use Cessation Counseling (CAG-00241N)

Dear Dr. Salive:

This letter is being submitted by several interested parties, including: Partners for Effective Tobacco Policy, a coalition of more than 60 national organizations - including the American Medical Association, the American Cancer Society, American Heart Association, and the American Lung Association - committed to reducing death and disability caused by tobacco use; and the Society for Research on Nicotine and Tobacco, the leading scientific society in the world devoted exclusively to the generation of new knowledge concerning nicotine and tobacco. We are writing to express our strong support for the request for a National Coverage Determination for tobacco cessation counseling under Medicare submitted by Partnership for Prevention on June 23, 2004.

The request by the Partnership for Prevention is a comprehensive, thorough, and highly credible assessment of the clinical merits and cost-related benefits of providing tobacco cessation counseling services under the Medicare program. The evidence used in support of their request is current and authoritative and represents the best science available on the subject. Further, the evidence upon which the request has been made represents the collective expertise of some of the nation's most prestigious scientific and medical organizations, including the Agency for Health Care Research and Quality, the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute on Drug Abuse, the Centers for Disease Control and Prevention, and the University of Wisconsin Medical School's Center for Tobacco Research and Intervention. In addition, this request is consistent with the recommendations of other key programs and advisory bodies within the Department of Health and Human Services, including Secretary Thompson's Steps to a Healthier U.S. Initiative and the report of the Interagency Committee on Smoking and Health, Subcommittee on Cessation.

In our view, it is important to note that tobacco cessation counseling services target those individuals who are suffering most and have a strong potential for improved health should they receive these services. This is significant for several reasons. First, the evidence is overwhelming concerning the health risks of using tobacco products, particularly for long periods of time (e.g., decades). In fact, according to Surgeon General Richard Carmona in his May 27, 2004 remarks releasing his office's most recent report on tobacco use in the United States, "… smoking causes disease in nearly every organ in the body, at every stage of life" (emphasis added). The Surgeon General's report specifically found, with respect to tobacco use among seniors in the United States, that:

Smoking reduces bone density among postmenopausal women.
Smoking is causally related to an increased risk for hip fractures in men and women and that of the 850,000 fractures occurring in individuals over age 65, 300,000 are hip fractures. Persons with a hip fracture are 12% to 20% more likely to die than those without a hip fracture.
Smoking is related to nuclear cataracts of the lens of the eye, the most common type of cataract in the United States. Cataracts are the leading cause of blindness worldwide and a leading cause of visual loss in the United States. Smokers have two to three times the risk of developing cataracts as nonsmokers.
Chronic obstructive pulmonary disease (COPD) is consistently among the top 10 most common chronic health conditions and among the top 10 conditions that limit daily activities. Prevalence of COPD is highest in men and women 65 years of age and older (16.7% among men and 12.6% among women).

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

While all of our organizations are interested in preventing the initiation of tobacco use, this request is not about preventing initiation. Rather, this request is solely focused on tobacco cessation. Tobacco use cessation counseling is appropriate for coverage as a Medicare benefit because it is reasonable and necessary for the treatment of an illness or injury, specifically a tobacco-related illness or injury. Further, tobacco use cessation counseling has been scientifically proven through clinical trials to be both a clinically effective and cost effective service. For example, in a July 2001 study published in the American Journal of Preventive Medicine (AJPM), the authors found, using a one to ten scale with ten being the highest possible score, that of the thirty preventive services evaluated, tobacco cessation counseling ranked second in its degree of effectiveness, scoring a nine out of 10 (the highest ranking was for childhood vaccines which scored a 10). The AJPM study examined the burden of disease prevented by each service and cost effectiveness. Of particular interest in relation to this request was the authors' finding that among other preventive services currently covered by Medicare, colorectal cancer screening received a score of eight and mammography screening scored a six.

In addition to the AJPM study, we also know that in individuals 65 and older who smoke, that those who quit can achieve cardiovascular mortality rates similar to those of nonsmokers. Further, a person who smokes more than 20 cigarettes per day but quits at age 65 will still, on average, increase his or her life expectancy by two to three years. And, smoking cessation in older smokers can reduce the risk of myocardial infarction, death from coronary heart disease, and lung cancer, while abstinence can promote more rapid recovery from illnesses that are exacerbated by smoking and can improve cerebral circulation.

Again, the evidence provided in support of this request is overwhelming and highly credible. We know that cessation works and we know that older age is not a barrier to successfully quitting since seniors who do try to quit are 50 percent more likely to be successful than all other age groups when they try. , Approval of this request will give all seniors who use tobacco and want to quit a greater opportunity to succeed and to live a healthier, longer and higher quality of life.

Finally, the recently enacted legislation to provide prescription drug coverage under Medicare also made available FDA-approved prescription cessation aids (e.g., nicotine nasal spray, nicotine inhaler, bupropion SR, legend drug, nicotine patches). The availability of pharmacotherapy to health care providers will complement and reinforce the effectiveness of counseling. In fact, when combined, counseling and medications nearly doubles each respective intervention's quit rates.

Our organizations fully support this request for a National Coverage Determination for tobacco cessation counseling services under Medicare. Thank you for the opportunity to provide comments on this request.

Sincerely,

Action on Smoking or Health
American Academy of Family Physicians
American Association for Respiratory Care
American Cancer Society
American College of Chest Physicians
American College of Occupational and Environmental Medicine
American College of Physicians
American College of Preventive Medicine
American Heart Association
American Legacy Foundation
American Lung Association
American Medical Association
American Medical Women's Association
American Psychological Association
American Public Health Association
American Thoracic Society
Association of Maternal and Child Health Programs
Campaign for Tobacco-Free Kids
Center for Tobacco Cessation
General Board of Church and Society of the United Methodist Church
Hadassah, the Women's Zionist Organization of America
Maine Coalition on Smoking or Health
Medical Society of the State of New York
National Association of County and City Health Officials
National Association of School Nurses
National Center for Policy Research for Women & Families
National Women's Law Center
Oncology Nursing Society
Oral Health America
Society for Public Health Education
Society for Research on Nicotine and Tobacco
University of Wisconsin Medical School/Center for Tobacco Research and Intervention

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

U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2004.

McLellan AT, Lewis DC, O'Brien CP, Kleber HD, "Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation," Journal of the American Medical Association, October 4, 2000: 284: 1689-1695.

Department of Health and Human Services, Food and Drug Administration, "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents," Final Rule, 21 CFR Parts 801, 803, 804, 807, 820, and 897, Docket Number 95N-0253, Federal Register, Volume 61, No. 168, August 28, 1996.

Halpin, HL et al, "State Medicaid Coverage for Tobacco-Dependence Treatments --- United States, 1994-2002," Morbidity and Mortality Weekly Report, January 30, 2004 / 53(03);54-57, January 30, 2004.

Coffield, A, et al. "Priorities Among Recommended Clinical Preventive Services," American Journal of Preventive Medicine, July 2001, 21(1).

Lacroix, AZ, "Thiazide diuretic agents and prevention of hip fracture," Comprehensive Therapy 1991, 17(8)30-9 [published erratum in Comprehensive Therapy 1992 February, 18(2):42]; RAND, 2000.

Sachs, DPL, "Cigarette Smoking: Health Effects and Cessation Strategies," Clinical Geriatric Medicine 1986; 2:337-362; RAND 2000.

CDC. Smoking cessation during previous year among adults-United States, 1990 and 1991. MMWR.1993;42(26):504-7.

Clark MA, Rakowski W, Kviz FJ, Hogan JW. Age and stage of readiness for smoking cessation. J Gerontol B Psychol Sci Soc Sci. 1997;52(4):S212-21.

Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000.