January 19, 2005 Steve Phurrough, MD Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services Mail Stop C1-09-28 7500 Security Boulevard Baltimore, Maryland 21244 RE: Proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling (CAG 00241N) Dear Dr Phurrough: On behalf of the North American Quitline Consortium (NAQC), I would like to thank CMS for the opportunity to provide comments on the proposed Coverage Decision Memorandum for Smoking and Tobacco Use Cessation Counseling A quitline is a health service that offers telephone support – information and counseling – for people who want to quit using tobacco NAQC is a newly established organization that aims to maximize the access, use and effectiveness of quitlines; provide leadership and a unified voice to promote quitlines; and offer a forum to link those interested in quitline operations NAQC includes health departments, quitline service providers, research institutes and national organizations in the United States and Canada and enables professionals from these organizations to learn from each other and to improve quitline services NAQC strongly supports the December 23, 2004 announcement by the Centers for Medicare and Medicaid Services (CMS) proposing coverage for tobacco cessation counseling services under Medicare The decision by CMS will have a significant, positive impact on the health of millions of seniors for many years to come Our comments may be summarized as follows: • The proposed coverage decision memorandum did not address adequately the use and effectiveness of quitlines for smoking and tobacco use cessation counseling Welldesigned studies demonstrate that quitlines bring about abstinence, which has been • • • • shown to improve health outcomes Thus, the evidence is adequate to conclude that quitlines are “reasonable and necessary.” Quitlines meet several different benefit categories as defined in the Social Security Act However, CMS must modify its current interpretation of the “incident to” benefit category to permit broader access to quitlines Medicare Advantage plans have the right to choose how Medicare-covered services will be provided CMS should clarify in the final coverage decision for smoking and tobacco cessation services that plans continue to enjoy flexibility regarding choice of provider and the manner in which these services are delivered The proposed requirement that counseling only be provided by individuals trained in tobacco use cessation counseling is appropriate NAQC recommends that CMS consider incorporating the Standards of Practice developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD) The proposal to cover cessation attempts per year, with a maximum of four intermediate or intensive sessions per attempt is appropriate In order to clarify the role that quitlines may play in delivering smoking and tobacco use cessation services to Medicare beneficiaries, it is particularly important for CMS to address each of the first three issues explicitly in its final decision memorandum More detailed comments on these specific issues are provided following a brief overview of quitline services Overview of Quitlines Quitlines are a health service that offers telephone support – information and counseling – for people who want to quit using tobacco Quitline services are based on several models Generally, these include proactive or reactive telephone counseling or a mix of the two.1 Although some tobacco quitlines are part of wider national hotline services covering multiple services, the majority of state quitlines are specific to smoking cessation.2 In addition to proactive and/or reactive telephone counseling, tobacco quitlines offer a range of services that varies from state to state These services can include: mailed materials, referrals to other cessation services, taped messages or web programs, the provision of nicotine replacement therapies (NRTs) or assistance in obtaining NRTs, and language- or culturally-appropriate services directed toward specific state populations.3 A snapshot of the services available in each state is shown on the map at www.NAQuitline.org At the North American Conference of Smoking Cessation Quitlines, Lichtenstein noted, “Telephone counseling represents a major accomplishment for the research community in that an empirically developed and established intervention has been adopted and institutionalized by state government and now provides help to thousands of smokers.”4 Although the first quitlines were implemented in the 1970s, the number of states operating quitlines began growing steadily only since California began a tobacco helpline in 1992 By the close of 2004, 38 states had established and are maintaining quitline services.5 The remaining states and the District of Columbia are in the process of establishing quitlines; currently they receive services from national quitline providers The number of smokers who receive intensive counseling from quitlines is limited by the funding that is available to the quitline.7 In a June 2004 survey conducted by NAQC, we found that the average annual state budget for quitline operations was about $500,000, with a range from $150,000 to over $3 million.8 Although quitlines currently reach only 1-2% of smokers, it is estimated that with adequate funding, quitlines could reach about 15% of smokers.9 As a result of limited funding, many state quitlines have established criteria to determine who is eligible for intensive quitline counseling The most frequent approach to eligibility criteria is to make a single counseling session available to all smokers and to limit more intensive counseling to those who are uninsured and/or those who are ready to quit.10 In many states, smokers who are Medicare beneficiaries may not be receiving intensive counseling from quitlines due to funding limitations in the state Quitlines are “reasonable and necessary.” We not believe the proposed coverage decision memorandum adequately addressed the use and effectiveness of quitlines for smoking and tobacco use cessation counseling Published and ongoing research, both in the United States and abroad, documents the effectiveness of telephone counseling for smoking cessation Both the efficacy and the effectiveness of quitline counseling have been demonstrated by several meta-analyses as well as numerous individual studies A meta-analytic review of 13 randomized trials conducted by Lichtenstein et al.11 found proactive telephone counseling resulted in a sustained increase in cessation for intervention groups as compared to control groups (pooled odds ratios of 1.34 at short-term follow-up – 3-6 months and 1.20 at long-term follow-up – greater than months) A U.S Public Health Service Clinical Practice Guideline meta-analysis of 58 studies describing psychosocial treatments for cessation demonstrated a 1.2 estimated odds ratio for proactive telephone counseling compared to no intervention.12 Similarly, a Cochrane Review of 27 trials of telephone counseling for smoking cessation, using rigorous criteria of at least six months abstinence, concluded that proactive telephone counseling is effective and particularly successful when multiple phone contacts take place at the time of a quit attempt.13 The reviewers noted that counselor calls are “likely to increase the chances of quitting relatively by around 50 percent compared to a minimal intervention such as providing standard self-help materials.” Evidence for the effectiveness of reactive telephone counseling has not been evaluated in the same rigorous and systematic manner as proactive telephone counseling, in part because randomization is more difficult since it requires that some callers receive less or no assistance 14 However, several published evaluations have followed and assessed quitline callers’ outcomes Ossip-Klein et al.15 investigated the effects of a smokers’ “hotline” combined with self-help materials More than 1800 smokers were recruited and randomly assigned to self-help materials or self-help materials plus hotline access and followed for 18 months Results indicated a consistent significant effect for both abstinence and relapse prevention In another study in Scotland,16 a cohort of smokers (n=848) who contacted a quitline were followed up by telephone at three weeks, six months and one year At one year, 23.6% of persons reported abstinence and 88% of persons reported having made positive behavioral changes in their smoking Zhu et al.17 conducted a randomized, controlled trial within the California Smokers’ Helpline using a control group of 1309 callers and a treatment group of 1973 callers Self-help manuals were provided to all callers Participants in the treatment group were immediately assigned to a counselor while those in the control group received counseling if they called back and requested it Counseling was provided for 72.1% of the treatment group and 31.6% of the control group Smokers were evaluated at 1, 3, 6, and 12 months and abstinence rates were consistently higher in the treatment group The abstinence rate at 12 months was 23.3% for the treatment groups versus 18.4% for the control group Likewise, a randomized, controlled trial in Spain18 indicated that telephone counseling in combination with self-help materials approximately doubled abstinence rates at 12 months A randomized trial of telephone counseling conducted by the American Cancer Society followed 3500 smokers who called for cessation help Callers received either mailed self-help materials or self-help materials plus five telephone counseling sessions Smokers who received the telephone counseling demonstrated higher quit rates at three and six months than the self-help only group.19 Research conducted in smokers ages 65 and older demonstrates high quitline utilization rates and significant benefits from the treatment services In a small trial (177 subjects) with smokers ages 60 and older conducted by Ossip-Klein et al,20 smokers were randomized to a mailings or a proactive calls condition All participants had access to the reactive quitline At 12 months, 50.5% of all subjects had called the reactive quitline at least once, and 25% had spoken with a quitline counselor at least once during a reactive call These are among the highest utilization rates reported in the literature More recently, an evaluation of the Wisconsin Senior Patch Program21 showed that nearly all participants were satisfied with the quitline program and would recommend it to others (94.9% and 97.8%, respectively) Eight months after enrollment in the program, 92% made a serious quit attempt, 44.9% had not used tobacco in the last seven days and 44.6% had not used tobacco in a month or more Although the results have not yet been published from CMS’ Medicare Stop Smoking Program, we expect that they will be consistent with the studies described above This demonstration will compare usual care (smoking cessation information) to one of three different types of smoking cessation services and assess their impact on quit rates The three options are: • Reimbursement for provider counseling only • Reimbursement for provider counseling + FDA-approved prescription or nicotine replacement pharmacotherapy • A telephone counseling quitline + reimbursement for nicotine replacement therapy Early estimates of self-reported quit rates indicate that those assigned to the quitline intervention achieved a quit rate of 32.5%.22 We urge CMS to review the findings from this key trial, which was designed to help answer the question about the effectiveness of different counseling venues on beneficiaries, before issuing its final decision memo All these well-designed studies demonstrate that quitlines bring about abstinence, which has been shown to improve health outcomes Thus, the evidence is adequate to conclude that quitlines are “reasonable and necessary.” Benefit categories Under the draft national coverage decision memorandum, smoking cessation services could be eligible for Medicare coverage when they are provided as: • • • • • physicians services; services furnished incident to a physician’s professional service; outpatient hospital services; rural health clinic and federally qualified health center services; services which would be physicians’ services if furnished by a physician and which are performed by a physician assistant, nurse practitioner or clinical nurse specialist; • • qualified psychologist services; or clinical social worker services Although some quitline services might qualify for coverage on this basis (for example, when provided as part of outpatient hospital, rural health clinic or federally qualified health center services), the majority of quitline services may not satisfy Medicare’s coverage requirements unless changes are included in the final coverage decision Given the extensive literature demonstrating that quitline counseling is effective, NAQC requests that CMS make the modifications necessary to include these services in its final coverage policy For example, CMS should waive the requirement that quitline cessation counseling services be provided in a face-to-face encounter with the patient This waiver would apply only to smoking cessation services provided by professionals meeting specific standards in tobacco counseling and intervention, as recommended below in the section on training requirements NAQC also urges CMS to modify the requirements for services provided “incident to” physician care so that quitlines could qualify for coverage on this basis Frequently, physicians “ask” patients whether they smoke, “advise” them to quit, and “refer” them to quitlines for counseling by trained staff We believe that the requirement for direct personal supervision could be deemed to be met when a quitline meeting appropriate standards, such as might be established by a state for example, partners with a physician to provide smoking cessation services to the physician’s patients We are confident that these suggestions are consistent with Medicare’s approach to financing high quality health services for all seniors while at the same time supportive of the quitline services that Lichtenstein described as “a major accomplishment for the research community in that an empirically developed and established intervention has been adopted and institutionalized by state government and now provides help to thousands of smokers.”23 The infrastructure for quitlines has been developed and is being maintained by states Quitlines are a vehicle for providing increased access to high quality cessation services to many more Medicare beneficiaries than is possible with face-to-face counseling alone Coverage of quitline services under Medicare managed care Medicare Advantage plans provide health care to about 13% of beneficiaries Although these plans are required to follow national coverage determinations and make available to their Medicare enrollees all of the services that are available under traditional Medicare, program rules have long given private plans considerable flexibility in provider selection and benefit delivery For example, the preamble to the June 29, 2000, final rule implementing changes to the requirements for private plans states that “When a health care service can be Medicarecovered and delivered in more than one way, or by more than one type of practitioner, we continue to recognize a managed care organization's right to choose how services will be provided These decisions have been left to managed care organizations to allow them to maximize their value purchasing power, and use resulting savings to provide services not covered by the Medicare program.” 24 NAQC urges you, in drafting the final national coverage determination for smoking and tobacco cessation services, to clarify that while plans are required to apply its clinical criteria regarding eligibility for such counseling and any periodicity limits it may specify, they continue to enjoy flexibility regarding choice of provider and the manner in which these services are delivered The training requirements for tobacco cessation counseling Adequate training is a key component in providing high quality and effective cessation counseling CMS should ensure that tobacco treatment is delivered by professionals meeting specific standards in tobacco counseling and intervention NAQC recommends that CMS consider incorporating the Standards of Practice developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD) These standards were developed for providers of cessation treatment and are based on the core competencies needed to implement the evidence base for effective cessation treatment There are many existing training programs in tobacco cessation counseling Examples of successful programs include the following: • • • • • Arizona Tobacco Education & Prevention Program’s Training for Healthcare Professionals (http://www.tepp.org/actev/healthcare/index.html): The state of Arizona offers CME and CEU training to a wide range of health professionals based on the clinical practice guidelines for treating tobacco use and dependence Center for Tobacco Research and Intervention (http://www.cme.uwisc.org): CTRI offers five web-based modules for continuing medical education to help clinicians implement the clinical practice guidelines for treating tobacco use and dependence Mayo School of Continuing Education Nicotine Dependence Seminar (http://www.mayoclinic.org/ndc-rst/conference.html): Mayo Clinic offers in-person day CME and CEU conferences on tobacco use and dependence; 1-3 day CME and CEU customized workshops on issues related to tobacco dependence; CEU workshops on Motivational Interviewing; and a five day intensive competency-based certification program for tobacco treatment specialists University of Massachusetts Medical School (http://www.umassmed.edu/behavmed/tobacco): U Mass offers a program for those interested in earning the designation of "certified tobacco treatment specialist" through an intensive competency-based training program University of Medicine and Dentistry of New Jersey Tobacco Dependence Program (http://www.tobaccoprogram.org): The program offers 1-2 hour seminars, day-long trainings and conferences, along with a 5-Day Tobacco Dependence Treatment Specialist Training Length, frequency, and total number of smoking cessation sessions Medicare proposes to cover cessation attempts per year Each attempt may include a maximum of four intermediate or intensive sessions, with the total annual benefit covering up to sessions in a 12 month period The practitioner and patient have flexibility to choose between intermediate or intensive cessation strategies for each attempt NAQC supports this proposal Conclusion Medicare coverage is contingent upon a determination that a service meets a benefit category, is not specifically excluded from coverage, and the item or service is ‘‘reasonable and necessary.’’ We believe quitlines meet these requirements We are confident that coverage of quitlines would be consistent with Medicare’s approach to financing high quality health services for all seniors Lichtenstein described quitline services as “a major accomplishment for the research community in that an empirically developed and established intervention has been adopted and institutionalized by state government and now provides help to thousands of smokers.”25 The infrastructure for quitlines has been developed and is being maintained by states Quitlines are a vehicle for providing increased access to high quality cessation services to many more Medicare beneficiaries than is possible with face-toface counseling alone Thank you, again, for the opportunity to provide comments on this important health care issue Should you have any questions about NAQC’s comments, please contact me via email at LBAILEY@americanlegacy.org or via telephone at 602-595-3273 Sincerely, Linda A Bailey, JD, MHS Executive Director 4142 E Stanford Drive Phoenix, AZ 85018 REFERENCES Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM: Telephone counseling for smoking cessation: Rationales and meta-analytic review of evidence Health Education Research 1996, 11:243-257 Ossip-Klein DJ, McIntosh S: Quitlines in North America: Evidence base and applications American Journal of Medical Science 2003, 326:201-205 See Ossip-Klein et al (2003) above and Zhu S: Survey of quitlines in North America Presented at North American Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002 Lichtenstein E: A review of the efficacy of quitlines Presented at the North America Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002 See: ADHA Smoking Cessation Initiative: Ask, advise, refer Available at: www.askadviserefer.org/quitlines 2003; Center for Tobacco Cessation: State Quitline Information Available online: www.ctcinfo.org/upload/quitl_us_chartpdf2003, December; and North American Quitline Consortium map and facts page at www.NAQuitline.org See North American Quitline Consortium map and facts at www.NAQuitline.org McAfee T: Increasing the population impact of quitlines Presented at the North American Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002 See North American Quitline Consortium map and facts at www.NAQuitline.org U.S Department of Health and Human Services, Interagency Committee on Smoking and Health A National Action Plan for Tobacco Cessation, Subcommittee on Cessation, Michael C Fiore, MD, MPH, chair, February 2003 (available at www.ctcinfo.org) 10 See North American Quitline Consortium map and facts at www.NAQuitline.org 11 Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM: Telephone counseling for smoking cessation: Rationales and meta-analytic review of evidence Health Education Research 1996, 11:243-257 12 Fiore MC, Bailey WC, Cohen SJ: Treating tobacco use and dependence: Clinical Practice Guideline Rockville, MD, U.S Department of Health and Human Services, U.S Public Health Service, 2000 13 Stead LF, Lancaster T, Perera R: Telephone counseling for smoking cessation Cochrane Databse Syst Rev 2003:CD002850 14 See Stead et al (2003) and also Lichtenstein et al (1996) above 15 Ossip-Klein DJ, Giovino GA, Megahed N, Black PM, Emont SL, Stiggins J, Shulman E, Moore L: Effects of a smokers’ hotline: Results of a 10-county self-help trial Journal of Consulting & Clinical Psychology 1991, 59:325-332 16 Platt S, Tannahill A, Watson J, Fraser E: Effectiveness of antismoking telephone helpfline: Follow up survey British Medical Journal 1997, 314:1371-1375 17 Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E: Evidence of real-world effectiveness of a telephone quitline for smokers New England Journal of Medicine 2002, 347:1087-1093 18 Miguez MC, Vazquez FL, Becona E: Effectiveness of telephone contact as an adjunct to a self-help program for smoking cessation: A randomized controlled trial in Spanish smokers Addictive Behaviors 2002, 27:139-144 19 Rabius V, McAlister AL, Geiger A, Huang P, Todd R: Telephone counseling increases cessation rates among young adult smokers Health Psychol 2004, 23:539-541 20 Ossip-Klein DJ, Carosella AM, Krusch DJ: Self-help interventions for older smokers Tobacco Control 1997;6:188-193 21 Zbikowski SM, Bush T, Hantz K, Mahoney LD, Garcia-Cabale M, McAfee T: Wisconsin tobacco quit line senior patch program evaluation report Center for Health Promotion 2003; 32 pp 22 See Healthy Aging Initiative Demonstration Projects Medicare Stop Smoking Program at http://63.240.208.148/researchers/demos/healthyaging/1b.asp 23 Lichtenstein E: A review of the efficacy of quitlines Presented at the North America Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002 24 25 See Federal Register, vol 65, p 40207 (June 29, 2000 Lichtenstein E: A review of the efficacy of quitlines Presented at the North America Conference of Smoking Cessation Quitlines, Phoenix, AZ, May 8-10, 2002 ... “reasonable and necessary.” We not believe the proposed coverage decision memorandum adequately addressed the use and effectiveness of quitlines for smoking and tobacco use cessation counseling. .. delivering smoking and tobacco use cessation services to Medicare beneficiaries, it is particularly important for CMS to address each of the first three issues explicitly in its final decision memorandum. .. final coverage decision for smoking and tobacco cessation services that plans continue to enjoy flexibility regarding choice of provider and the manner in which these services are delivered The proposed