Clinical Policy Title: Tobacco control interventions Clinical Policy Number: 17.02.05 Effective Date: Initial Review Date: Most Recent Review Date: Next Review Date:

December 1, 2013 June 16, 2013 June 15, 2016 June 2017

Policy contains:  Acupuncture.  Nicotine replacement.

Related Policies: CP# 03.02.03 Acupuncture ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First’s clinical policies are not guarantees of payment.

Coverage policy Keystone First considers tobacco use control to be medically necessary in patients who have a confirmed willingness to quit. Tobacco use control (e.g., smoking avoidance or cessation) includes health promotion, which fosters wellness in general and thus reduces the likelihood of disease, disability and premature death in a nonspecific manner. Covered preventive services include:  Lifestyle counseling up to seventy (70) sessions per calendar year with intensity determined by provider and patient. • Pennsylvania coverage of smoking cessation drugs includes: o NRT Gum. o NRT Patch. o NRT Nasal Spray NRT Lozenge NRT Inhaler. o Varenicline (Chantix) Bupropion (Zyban). Limitations: Keystone First considers the use of the following items not medically necessary for smoking cessation:  Antidepressants other than those cited as covered [e.g., selective serotonin release 1

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inhibitors (SSRIs)]. Anxiolytics. Opioid antagonists. Silver acetate. Mecamylamine. Lobeline. Acupuncture. Hypnotism. E-cigarette.

NOTE: The following codes are not included in the Medicaid medical fee schedule in Pennsylvania 4000F - Tobacco use cessation intervention, counseling (COPD, CAP, CAD, Asthma, DM, PV) 4001F - Tobacco use cessation, intervention, pharmacologic therapy 99406 - Smoking and tobacco use cessation counseling visit, intermediate, greater than 3 minutes up to 10 minutes G0436 - Smoking and tobacco cessation counseling visit for the asymptomatic patient; intermediate, greater than 3 minutes, up to 10 minutes S4995 - Smoking cessation Gum S9453 - Smoking cessation classes, nonphysician provider, per session Alternative covered services: None apply. Background In the year 2000, the leading cause of death in the United States was tobacco use, which resulted in some 435,000 deaths, or 18.1 percent of total deaths. The causal relationship between cigarette smoking and lung cancer was first documented in the 1950s. Smoking and other forms of tobacco use have since been implicated in preventable deaths and global burden of disease, including cancers (e.g., lung cancer), cardiovascular disease, lung disease [(e.g., chronic obstructive pulmonary disease (COPD)] and complications of pregnancy and diabetes. The direct and indirect costs (e.g., lost productivity) of tobacco use to individuals, the health care system, and society in general are enormous. Searches

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Keystone First searched PubMed and the following databases: • UK National Health Services Center for Reviews and Dissemination. • Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other evidence-based practice centers. • The Centers for Medicare & Medicaid Services (CMS). We conducted searches on May 12, 2016. Searched terms were: "tobacco control (MeSH),"" smoking (MeSH)" and "cessation". We included: • Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. • Guidelines based on systematic reviews. • Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies. Findings A large body of evidence accumulated over the last two generations of the American experience document the risk and harms of cigarette smoking and use of other tobacco products. Sixty years into the study of this public health, there is still a tremendous amount of ongoing research to identify and clarify the multiple inputs that shape the use, the withdrawal and cessation from, and the treatment of complications associated with tobacco use. Recent investigation has focused on financial incentives as part of formal smoking cessation programs. Tappan (2015) looked at a population truly at risk from lifestyle habits: pregnant women smokers and their newborn children. Although newborn weights were not affected by smoking cessation in women who quit, nearly a quarter of the participants offered monetary gains were enticed to stop smoking (for a while). The pitfalls of financial incentive become obvious when the incentives stop. Cahill (2015) noted that a monetary reward of approximately $700 USD enticed 31 percent of pregnant women smokers in a large number of settings to quit smoking while they were in place. Mantzari (2015) noted a similar change in lifestyle among the general population that endured for 18 months overall but only three months after incentives stopped. The nicotine patch failed to help pregnant women smokers quit in a clinical trial of 402 expectant women randomized to patches with nicotine and controls with placebo patches (Berlin, 2014). Compliance was measured by testing expired carbon monoxide (CO) levels in the subjects once weekly. Birth weights were roughly the same in treated and controls, as was the number of smokers in both groups at the trial's end. Finally, pregnant women were not particularly helped by an exercise program as an adjunct to smoking cessation (Ussher, 2015). A large clinical trial found that not only was there no significant differences in activity (as shown by accelerometer data) between exercise and baseline-activity controls, the rates of 3

smoking abstinence were also undifferentiated: 8 percent who reported exercising versus 6 percent who did not were able to stop smoking. Another special population group with regards to smoking, the hospitalized mentally ill, were shown to benefit from tobacco control programs that included NRT products (i.e., nicotine replacement gum and patches). At 18 months, 20 percent of those in the treatment group (which included a variety of psychiatric illnesses) stopped smoking, compared to just 7.7 percent of controls (Prochaska, 2013). A helpful side benefit of smoking cessation was a reduction in rates of readmission to the hospital compared to control. Operative risk increases substantially in the presence of chronic disease and smoking is one of the most common pre-operative risk factors cited in studies of morbidity and mortality from surgical procedures. Measures intended for the short-term gain of reduced peri and post-operative complications (i.e., wound complications) were also effective at long-term control of tobacco in a systematic review inclusive of 2010 participants (Thomsen, 2014). The effect was enhanced by weekly counseling sessions and behavioral modification instruction over four to eight weeks postoperatively. Attention deficit hyperactivity disorder (ADHD) is a frequent comorbid concomitant of cigarette smoking. A systematic review (n=2360) linked treatment with the stimulants d-amphetamine and methylphenidate to lower smoking rates among treated ADHD patients (Schoenfelder, 2014). A notable side finding was that the impact of the stimulants on smoking reduction is greater with more severe concurrent psychopathology. Evidence for pharmaceutical measures in tobacco control continued to accumulate weight with a number of drugs showing promise and benefit to smokers:  A sizable systematic review of 3,336 participants found NRT effective and safe for smoking cessation (Hollands, 2015).  A large (n=10,761) systematic review found varenicline safe (with regards to suicidal behavior) for promoting smoking cessation, though it does prompt nightmares and insomnia (Thomas, 2015).  A randomized controlled trial (RCT) of 1,510 participants found varenicline increases cessation rates at one year after an initial 24 weeks of treatment (Ebbert, 2015).  Varenicline in combination with NRT shows more promise than monotherapy with varenicline (Koegelenberg, 2014).  Bupropion and nortriptyline have similar efficacy in tobacco control as NRT, according to another large systematic review (n=13,728), though not as beneficial as varenicline (Hughes, 2014).  The same study concluded that SSRIs and MAO inhibitors do not aid smoking cessation (Hughes, 2014). In what may be the most comprehensive assessment yet of multiple allopathic and homeopathic treatments for smoking cessation, Cochrane (Hughes, 2014) reviewed 44 trials inclusive of 13,728 patients. Among their conclusions:  Bupropion and nortriptyline aid long-term smoking cessation.  Evidence suggests the mode of action of bupropion and nortriptyline is 4

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independent of their antidepressant effect and that they are of similar efficacy to nicotine replacement. Adverse events are rare and rarely lead to stopping medication. Evidence also suggests that bupropion is less effective than varenicline, but further research is needed to confirm this finding. Evidence suggests that neither selective serotonin reuptake inhibitors (e.g., fluoxetine) nor monoamine oxidase inhibitors aid in smoking cessation.

Acupuncture and acupressure continue to lack evidence of efficacy in tobacco control. In a small systematic review of 393 subjects, the results of acu-service were no different than being put on a waiting list control for long-term abstinence and tobacco cessation (White, 2014). No report on smoking can conclude without illuminating some of the darker sides of the habit. A retrospective review of colorectal cancer victims over a term of 20 years found smoking was associated with higher all-cause and colorectal-specific mortality (Yang, 2015). Stopping smoking did confer some benefit with regards to cancer mortality. Policy updates: McQueen (2016) examined past and present tobacco use in head and neck cancer patients (n=106) enrolled in a smoking cessation program. Sixty-nine (65%) successfully quit smoking by various means, including adoption of the e-cig as a substitute of tobacco. Age of first tobacco use did not differ between the smoking and cessation groups (p= .14), nor did hazardous drinking (p = .072). “Cold turkey” (i.e., stopping abruptly without smoking cessation aids) was the most common method attempted (n = 88, 83%) and most successful (n = 65, 94%). Nonusers achieved higher quit rates as compared with e-cig users (72% vs. 39%; p = .0057). E-cig use did not decrease the number of cigarettes smoked (463 cigarettes/month) versus that of nonusers (341 cigarettes/month; p = .2).The authors concluded that the e-cig did not decrease tobacco use, and patients who utilize e-cigs are less likely to achieve smoking cessation. A systematic review (Malas, 2016) examined the effectiveness of e-cigarettes as smoking cessation aids. The quality of the evidence in support of e-cigarettes’ effectiveness in helping smokers quit was assessed as very low to low, and the evidence on smoking reduction was assessed as very low to moderate. The majority of included studies found that e-cigarettes, especially second-generation types, could alleviate smoking withdrawal symptoms and cravings in laboratory settings; however, the evidence remains inconclusive due to the low quality of the research published to date. Well-designed randomized controlled trials and longitudinal, population studies are needed to further define the role of e-cigarettes in smoking cessation. Sherratt (2016) examined current practice in Great Britain for recommending use of the electronic cigarette (e-cigarette) as a smoking cessation aid. The authors queried thoracic physicians (n = 2,009), requesting them to complete an online survey concerning patient smoking history, perceptions of patient e-cigarette use, practitioner knowledge regarding sources of guidance pertaining to e-cigarettes, and practitioner advice. The majority of practitioners (81.4 %) reported responding to patient queries pertaining to e-cigarettes within the past year; however, far fewer (21.0 %) felt confident providing patients with e-cigarette advice. Practitioner confidence was found to differentiate by gender (p = 0.012) and medical specialty (p = 0.030), with nurses reporting particularly low levels of confidence in advising. The authors concluded that that patients defer to practitioners as a source of e-cigarette guidance, yet 5

few practitioners feel confident advising, and highlight that training should be delivered to equip practitioners with the knowledge and confidence to abet smoking cessation. Summary of clinical evidence: Citation McQueen (2016)

Content, methods, recommendations Key points:      

Malas (2016)

Key points:  

 Sherratt (2016)

Of 110 studied patients, 106 (96%) enrolled in the smoking cessation program (83% male, 82% caucasian), of whom 69 (65%) successfully quit smoking by various means, including adoption of the e-cig as a substitute of tobacco. Age of first tobacco use did not differ between the smoking and cessation groups (p= .14), nor did hazardous drinking (p = .072). “Cold turkey” (i.e., stopping abruptly without smoking cessation aids) was the most common method attempted (n = 88, 83%) and most successful (n = 65, 94%). Nonusers achieved higher quit rates as compared with e-cig users (72% vs. 39%; p = .0057). E-cig use did not decrease the number of cigarettes smoked (463 cigarettes/month) versus that of nonusers (341 cigarettes/month; p = .2). The authors concluded that the e-cig did not decrease tobacco use, and patients who utilize e-cigs are less likely to achieve smoking cessation.

The quality of the evidence in support of e-cigarettes’ effectiveness in helping smokers quit was assessed as very low to low, and the evidence on smoking reduction was assessed as very low to moderate. The majority of included studies found that e-cigarettes, especially second-generation types, could alleviate smoking withdrawal symptoms and cravings in laboratory settings; however, the evidence remains inconclusive due to the low quality of the research published to date. Well-designed randomized controlled trials and longitudinal, population studies are needed to further define the role of e-cigarettes in smoking cessation.

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Examined provider habit in recommending use of the electronic cigarette (e-cigarette) as a smoking cessation aid. The majority of practitioners (81.4 %) reported responding to patient queries pertaining to e-cigarettes within the past year; however, far fewer (21.0 %) felt confident providing patients with e-cigarette advice. Practitioner confidence was found to differentiate by gender (p = 0.012) and medical specialty (p = 0.030), with nurses reporting particularly low levels of confidence in advising. The authors concluded that that patients defer to practitioners as a source of e-cigarette guidance, yet few practitioners feel confident advising, and highlight that training should be delivered to equip practitioners with the knowledge and confidence to abet smoking cessation.

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Citation Tappin (2015)

Content, methods, recommendations Key points:    

 Cahill (2015)

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 Mantzari (2015)

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Monetary incentives promote smoking cessation among adults. SR of 34 studies weighed unspecified financial incentives offered to help smokers quit. Financial incentives increased behavior-change, with effects sustained 3 months after removal and 18 months overall.

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Thomas (2015)

Monetary incentives promote smoking cessation in pregnancy. Systematic review (SR) of 21 studies involving more than 8,400 participants. Monetary rewards to quit up to $700 USD. 12-week pregnancy and post-partum program yielded quit rate of 31% at six weeks compared with no quitters in the control group. Authors concluded incentives appear to boost smoking cessation rates while they are in place.

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Ussher (2015)

Financial incentives effective in pregnant smokers. RCT of 612 pregnant smokers randomized to financial incentives to abstain during term. More (22.5%) incentive smokers quit than non-incentive (8.6%). Newborn mean birth weight was 3,140 g (SD 600 g) in the incentives group and 3,120 (SD 590) g in the control group (P=0.67). Authors concluded incentives for smoking cessation in pregnancy are effective.

Exercise not effective as adjunct in pregnant smokers. RCT of 789 pregnant smokers randomized to exercise regimen versus baseline. No significant difference was found in rates of smoking abstinence at end of pregnancy between the physical activity and control groups (8% v 6%). According to the accelerometer data there was no significant difference in physical activity levels between the groups.

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Neuropsychiatric safety of varenicline. SR and meta-analysis of 39 randomized controlled trials (10,761 participants). Found no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression, or death with varenicline. There was evidence that varenicline was associated with a higher risk of sleep problems such as insomnia and abnormal dreams.

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Citation Yang (2015)

Content, methods, recommendations Key points:    

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Hollands (2015)

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 Ebbert (2015)

NRT effective and safe. SR of 8 studies and 3,336 participants. Evaluated pharmacological treatments for tobacco dependence (e.g., NRT). Adjunctive behavioral support included. NRT et al. safe and effective for smoking cessation.

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Koegelenberg (2014)

Smoking tied to higher colon cancer. Retrospective review of 2,548 persons diagnosed with invasive, nonmetastatic colorectal cancer between baseline 1992 and 2009. Current smoking was associated with higher all-cause mortality and colorectal cancer-specific mortality. Former smoking was associated with higher all-cause mortality but not with colorectal cancer-specific mortality. Postdiagnosis current smoking was associated with higher all-cause and colorectal cancer-specific mortality.

Varenicline for 24 weeks increases smoking cessation rates at 1 year. RCT of 1,510 participant smokers randomized to varenicline 1 mg bid x 24 weeks or placebo. Varenicline group (n = 760) had significantly higher continuous abstinence rates (32%) during weeks 15 through 24 versus placebo (6.9%). Varenicline group had significantly higher continuous abstinence rates vs. placebo during weeks 21 through 24 (37.8% versus 12.5%) and weeks 21 through 52 (27.0% versus 9.9%). Adverse events occurred in 3.7% of the varenicline group and 2.2% of the placebo group (P = .07).

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Varenicline with NRT more effective than varenicline alone. Prospective study of 446 smokers randomized to varenicline versus varenicline with NRT for 12 weeks. Combination treatment was associated with a higher continuous abstinence rate at 12 weeks (55.4% versus 40.9%), 24 weeks (49.0% versus 32.6%), and 6 months (65.1% versus 46.7%). Combination users suffered greater incidence of nausea, sleep disturbance, skin reactions, constipation and depression, with only skin reactions reaching statistical significance (14.4% versus 7.8%). Varenicline-alone group experienced more abnormal dreams and headaches.

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Citation Schoenfelder (2014)

Content, methods, recommendations Key points:   

 Thomsen (2014)

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Hughes (2014)

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Bupropion and nortriptyline aid long-term smoking cessation. SR of 44 trials (n = 13,728). Bupropion is less effective than varenicline. Bupropion and nortriptyline have similar efficacy to nicotine replacement. Neither selective serotonin reuptake inhibitors (e.g., fluoxetine) nor- monoamine oxidase inhibitors aid cessation.

Key points:     

 White (2014)

Preoperative smoking cessation may reduce postoperative morbidity and abet longterm abstinence. SR of 13 trials and 2010 postoperative participants showed varenicline and use of NRT conferred significant risk reduction in long-term smoking cessation and on wound complications. Varenicline and NRT did not confer effect on other postoperative complications. Effect was enhanced with adjuvant "intensive" behavioral therapy (i.e., weekly counseling sessions over four to eight weeks).

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Berlin (2014)

ADHD treatment tied to lower smoking risk. SR of 14 studies (n=2,360) linked stimulant treatments (i.e., damphetamine and methylphenidate) to lower smoking rates. Authors concluded consistent stimulant treatment of ADHD may reduce smoking risk. The effect was larger in samples with more severe psychopathology.

Nicotine patch ineffective in pregnant smokers. RCT of 402 pregnant smokers aged 18 years and between 12 – 20 weeks’ gestation who smoked at least five cigarettes a day. Randomized 203 to nicotine patches and 199 to placebo patches. Efficacy was measured by self-reporting and carbon monoxide levels in expired air. The mean birth weight was 3,065 g in the nicotine patch group and 3,015 g in the placebo patch group (P=0.41). The nicotine patch did not increase smoking cessation rates or birth weights.

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Acu-therapies of no benefit to long-term smoking cessation. SR of three studies, including 393 recruited volunteers, found acupuncture was no more effective than a waiting list control for long-term abstinence from smoking. No apparent evidence that acupuncture or acupressure benefit smoking cessation of six months or more.

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Citation Hughes (2014)

Content, methods, recommendations Key points:    

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Prochaska (2013)

Cochrane review of various tobacco control therapies. SR of 44 trials, n=13,728 found bupropion and nortriptyline equally effective and of similar efficacy to NRT. Trials comparing bupropion to varenicline showed significantly lower quitting with bupropion than with varenicline. There was no evidence of a significant effect for selective serotonin reuptake inhibitors alone (i.e., fluoxetine, paroxetine or sertraline) or as an adjunct to NRT. Benefit was not detected for monoamine oxidase inhibitors (i.e., moclobemide or selegiline), the atypical antidepressant venlafaxine, the herbal therapy St John's wort (hypericum) or the dietary supplement SAMe.

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NRT effective in psychiatric inpatient cohort. RCT of 224 residents of a psychiatric hospital were randomized to control or nicotine gum or patch. At 18 months, 20% of those in the treatment group had quit smoking, compared with just 7.7% of controls. There were fewer hospital readmissions among those in the treatment group — 44% compared with 56% in the control group. Psychiatric diagnoses: depression, bipolar disorder and schizophrenia. 75% were actively suicidal. Patients' diagnoses and the severity of their symptoms had no impact on intervention outcomes. Evidence-based tobacco dependence treatments can substantially increase quit rates among psychiatric inpatients.

Glossary Acupuncture and related therapies — Acupuncture is a traditional Chinese therapy using needles to stimulate particular points in the body. Related therapies include acupressure, laser therapy and electrical stimulation. Nicotine replacement therapy (NRT) — Aims to reduce the withdrawal symptoms associated with stopping smoking by replacing nicotine. NRT is available by skin patches, which deliver nicotine slowly, and by chewing gum, oral or nasal sprays, and lozenges or tablets, all of which deliver more quickly than patches but more slowly than cigarettes. References Professional society guidelines/other: American Lung Association (ALA) Freedom from Smoking (FFS) Program. ALA website. http://www.lung.org/stop-smoking/how-to-quit/freedom-from-smoking/. Accessed June 1, 2016. 10

U.S. Department of Health and Human Services (HHS), Public Health Service (PHS). Treating tobacco use and dependence: 2008 update. Website. http://www.ncbi.nlm.nih.gov/pubmed/18617085. Accessed June 1, 2016. Hayes Inc., Hayes Medical Technology Report. August 20, 2013. Smokers with mental illness can stop smoking. Lansdale, PA. Peer-reviewed references: Ahmed AI, Ali AN, Kramers C, Harmark LVD, Burger DM, Verhoeven WMA. Neuropsychiatric adverse events of varenicline: a systematic review of published reports. J Clin Psychopharmacol. 2013; 33(1):55 – 62. Akers L, Severson HH, Andrews JA, Lichtenstein E. Cost-effectiveness of self-help smokeless tobacco cessation programs. Nicotine Tob Res. 2007; 9(9):907 – 14. Barnes J, Dong CY, McRobbie H, Walker N, Mehta M, Stead LF. Does hypnotherapy help people who are trying to stop smoking? Cochrane Database Syst Rev. 2010. Berlin I, Grange G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ. 2014; 348: g1622. doi: 10.1136/bmj.g1622. Boyle RG, Solberg LI, Fiore MC. Electronic medical records to increase the clinical treatment of tobacco dependence: a systematic review. Am J Prev Med. 2010; 39(6):S77 – 82. Ussher M, Lewis S, Aveyard P, et al. Physical activity for smoking cessation in pregnancy: randomised controlled trial. BMJ. 2015; 350:h2145. doi: 10.1136/bmj.h2145. Cahill K, Hartmann-Boyce J, Perera R. Incentives for smoking cessation. Cochrane Database Syst Rev. 2016; 5:CD004307. Cahill K, Stead lF, Lancaster T. Can nicotine receptor partial agonists, including citisine, dianicline, and varenicline, help people to stop smoking? Cochrane Database Syst Rev. 2012. Carr AB, Ebbert J. Interventions for tobacco cessation in the dental setting. Cochrane Database Syst Rev. 2012. Issue 6. Carson KV, Brown MP, Peters M, Veale A, Esterman AJ, Smith BJ. Interventions for smoking cessation in indigenous populations. Cochrane Database Syst Rev. 2012; Issue 1. Chen YF, Madan J, Welton N, et al. Effectiveness and cost-effectiveness of computer and other electronic aids for smoking cessation: a systematic review and network meta-analysis. Health Technol Assess. 2012; 16(38):1– 205. Doll R, Hill AB. Smoking and carcinoma of the lung: preliminary report. BMJ. 1950:4682 – 748. 11

Ebbert JO, Hughes JR, West RJ, et al. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015; 313(7):687 – 94. doi: 10.1001/jama.2015.280. Farley AC, Hajek P, Lycett D, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2012; issue 1. Franck C, Ethical considerations of e-cigarette use for tobacco harm reduction. Respir Res. 2016;17. Glerisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012; 27(3):351 – 60. Grimshaw G, Stanton A. Are there any smoking cessations programmes which can help adolescents to stop smoking? Cochrane Database Syst Rev. 2010, issue 4. Hollands GJ, McDermott MS, Lindson-Hawley N, Vogt F, Farley A, Aveyard P. Interventions to increase adherence to medications for tobacco dependence. Cochrane Database Syst Rev. 2015; 2:CD009164. doi: 10.1002/14651858.CD009164.pub2. Hughes JR, Stead LF, Hartmann-Boyce J, Cahill K, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2014; 1:CD000031. doi: 10.1002/14651858.CD000031.pub4. Huttenen-Lenz M, Song F, Poland F. Are psycho-educational smoking cessation interventions for coronary heart disease patients effective? Meta-analysis of interventions. Brit J Health Psych. 2010; 15(4): 749 – 77. Johannson PM, Tillgren PE, Guldbrandsson KA, Lindholm LA. A model for cost-effectiveness analysis of smoking cessation applied to a quit-and-win contest for mothers of small children. Scand J Public Health. 2005; 33(5):343 – 52. Koegelenberg CF, Noor F, Bateman ED, et al. Efficacy of varenicline combined with nicotine replacement therapy versus varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014; 312(2):155-61. doi: 10.1001/jama.2014.7195. NCT01444131. Lancaster T, Stead LF. Does silver acetate help people stop smoking? Cochrane Database Syst Rev. 2012. Malas M, der Tempel J, Schwartz R, et al. Electronic Cigarettes for Smoking Cessation: A SystematicReview. Nicotine Tob Res 2016: ntw119v2-ntw119. Mantzari E, Vogt F, Shemilt I, Wei Y, Higgins JP, Marteau TM. Personal financial incentives for changing habitual health-related behaviors: A systematic review and meta-analysis. Prev Med. 2015; 75:75 – 85. doi: 10.1016/j.ypmed.2015.03.001. Epub April 2, 2015. Maziak W, Ward KD, Eissenberg T. Interventions for waterpipe smoking cessation. Cochrane Database 12

Syst Rev. 2007. Issue 4. McQueen N, Partington E, Harrington K, Rosenthal E, Carroll W, Schmalbach C. Smoking cessation and electronic cigarette use among head and neck cancer patients. Otolaryngol Head Neck Surg. 2016; 154,1:73-79. Mills EJ, Wu P, Lockhart I, Thorlund K, Puhan M, Ebbert JO. Comparisons of high-dose and combination nicotine replacement therapy, varenicline, and buprion for smoking cessation: a systematic review and multiple treatment meta-analysis. Annals of Internal Medicine. 2012; 44(6):588 – 97. Mokdad, AH, Marks JS, Stroup DF, and Gerberding JL. 2004. Actual causes of death in the United States, 2000. JAMA. 291 (10):1238 – 45. Nayan S, Gupta MK, Sommer DD. Evaluating smoking cessation interventions and cessation rates in cancer patients: a systematic review and meta-analysis. ISRN Oncology. 2011; 849023. (NICE) NHS National Institute for Health and Clinical Excellence. How to stop smoking in pregnancy and following childbirth. Public Health Intervention Guidance 26; 2010. Patnode CD, O’Connor E, Whitlock EP, Perdue LA, Soh C, Hollis J. Primary care-relevant interventions for tobacco use prevention and cessation in children and adolescents: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013; 158(4)253 – 60. Richard P, West K, Ku L. The return on investment of a Medicaid tobacco cessation program in Massachusetts. PlosOne. 2012; 7(1):e29665. Rigotti NA, Clair C, Munafồ MR, Stead LF. Interventions for smoking cessation in hospitalized patients. Cochrane Database Syst Rev. 2012; Issue 5. Rosen LJ, Noach MB, Winickoff JP, Hovel MF. Parental smoking cessation to protect young children: a systematic review and meta-analysis. Pediatrics. 2012; 129(1):141 – 52. Schoenfelder EN, Faraone SV, Kollins SH. Stimulant treatment of ADHD and cigarette smoking: a meta- analysis. Pediatrics. 2014; 133(6):1070-80. doi: 10.1542/peds.2014-0179. Epub 2014 May 12. Sherratt F, Newson L, Field J. Electronic cigarettes: a survey of perceived patient use and attitudes among members of the British thoracic oncology group. Respir Res. 2016; 17: 55. Silagy C, Mant D, Fowler G, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst. Rev. 2001. Simpson SA, Nonnemaker JM. New York tobacco control program cessation assistance: costs, benefits, and effectiveness. Int J Environ Res Public Health. 2013; 10:1037 – 47. Tappin D, Bauld L, Purves D, et al. Financial incentives for smoking cessation in pregnancy: randomised controlled trial. BMJ. 2015; 350:h134. doi: 10.1136/bmj.h134. 13

Thomas KH, Martin RM, Knipe DW, Higgins JP, Gunnell D. Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis. BMJ. 2015; 350:h1109. doi: 10.1136/bmj.h1109. Thomsen T, Villebro N, Moller AM. Interventions for preoperative smoking cessation. Cochrane Database Syst Rev. 2014; 3:CD002294. doi: 10.1002/14651858.CD002294.pub4. Ussher M, Lewis S, Aveyard P, et al. Physical activity for smoking cessation in pregnancy: randomised controlled trial. BMJ. 2015; 350:h2145. doi: 10.1136/bmj.h2145. ISRCTN48600346. White AR, Rampes H, Liu JP, Stead LF, Campbell J. Acupuncture and related interventions for smoking cessation. Cochrane Database Syst Rev. January 23, 2014; 1:CD000009. doi: 10.1002/14651858.CD000009.pub4. Yang B, Jacobs EJ, Gapstur SM, Stevens V, Campbell PT. Active smoking and mortality among colorectal cancer survivors: the Cancer Prevention Study II nutrition cohort. J Clin Oncol. 2015; 33(8):885-93. doi: 10.1200/JCO.2014.58.3831. Epub February 2, 2015. Clinical trials: Searched clinicaltrials.gov on June 1, 2016 using terms “tobacco smoking cessation”| Open Studies. 153 studies found, 4 relevant. Massachusetts General Hospital. Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc. (PiHQ). ClinicalTrials.gov Web site. http://clinicaltrials.gov/show/ NCT02601521. Published November 9, 2015. Updated October 2015. Accessed June 1, 2016. M.D. Anderson Cancer Center. Group Therapy for Nicotine Dependence: Mindfulness and Smoking. ClinicalTrials.gov Web site. http://clinicaltrials.gov/show/ NCT00297479. Published February 24, 2006. Updated December 2015.Accessed June 1, 2016. M.D. Anderson Cancer Center. Reward Sensitivity and Pharmacotherapy for Smoking Cessation. ClinicalTrials.gov Web site. http://clinicaltrials.gov/show/ NCT02162849. Published June 11, 2014. Updated April 2016.Accessed June 1, 2016. M.D. Anderson Cancer Center. Varenicline and Combined Nicotine Replacement Therapy (NRT) for Smoking Cessation. ClinicalTrials.gov Web site. http://clinicaltrials.gov/show/ NCT02271919. Published October 17, 2014. February 2016.Accessed June 1, 2016. CMS National Coverage Determinations (NCDs): NCD 210.4 Smoking and Tobacco-use Cessation Counseling- NCD- Effective July 2005. CMS Medicare Coverage Database Web site. https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=308&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All& KeyWord=tobacco+smoking+cessation&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAAB AAAAAAAA%3d%3d& Accessed June 1, 2016. 14

CAG-00241N Smoking and Tobacco-use Cessation Counseling- NCA- Effective March 2005. CMS Medicare Coverage Database Web site. https://www.cms.gov/medicare-coverage-database/details/ncadetails.aspx?NCAId=130&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&KeyWord= tobacco+smoking+cessation&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAA A%3d%3d&Accessed June 1, 2016. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals. CPT Code 4000F 4001F 99406 99407

ICD-10 Code

Description Tobacco use cessation intervention, counseling (COPD, CAP, CAD, Asthma, DM, PV) Tobacco use cessation intervention, pharmacological therapy (COPD, CAP, CAD, Asthma, DM, PV) Smoking and tobacco use cessation counseling visit; intermediate greater than 3 minutes, up to 10 minutes minutes Smoking and tobacco use cessation counseling visit;; intensive greater than 10

Description

F17.200 F17.201 F17.210 F17.211 F17.220 F17.221 F17.290 F17.291 Z87.891

Nicotine dependence, unspecified, uncomplicated Nicotine dependence, unspecified, in remission Nicotine dependence, cigarettes, uncomplicated Nicotine dependence, cigarettes, in remission Nicotine dependence, chewing tobacco, uncomplicated Nicotine dependence, chewing tobacco, in remission Nicotine dependence, other tobacco product, uncomplicated Nicotine dependence, other tobacco product, in remission Personal history of nicotine dependence

HCPCS Code G0436

Description Smoking and tobacco counseling visit for the asymptomatic patient; intermediate, greater than 3 minutes, up to 10 minutes Smoking and tobacco counseling visit for the asymptomatic patient; intermediate, greater than 10 minutes Smoking cessation gum Smoking cessation classes, nonphysician provider, per session

G0437 S4995 S9453

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