Clinical Policy Title: Botanical marijuana for medical use

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1 Clinical Policy Title: Botanical marijuana for medical use Clinical Policy Number: Effective Date: January 1, 2015 Initial Review Date: August 20, 2014 Most Recent Review Date: October 13, 2015 Next Review Date: October 2016 Policy contains: Medical marijuana. Cannabis. Tetrahydrocannabinol. Hydrocannabinol. Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania 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 AmeriHealth Caritas Pennsylvania 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. AmeriHealth Caritas Pennsylvania 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. AmeriHealth Caritas Pennsylvania s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the use of botanical marijuana to be investigational and, therefore, not medically necessary. Limitations: For the purpose of this policy, the term marijuana refers to the dried leaves and flowers of marijuana, and any mixture or preparation thereof, and does not include U.S. Food and Drug Administration (FDA)-approved drugs that may contain active ingredients that are present in marijuana (e.g., dronabinol [Marinol ] or nabilone [Cesamet ]). This policy applies to any method of absorption, including but not limited to smoking, vaporizing, nasal or oral sprays and oral ingestion. None. Alternative covered services: 1

2 FDA-approved drugs represented in evidence-based practice standards. Background Cannabis, also known as marijuana, is the dried leaves and flowering tops of the cannabis plant, most commonly, cannabis sativa. Cannabis produces terpenophenolic compounds called cannabinoids, which activate specific receptors found throughout the body, particularly in the central nervous system and the immune system, causing pharmacologic effects in the body. Tetrahydrocannabinol (THC) is the main cannabinoid found in cannabis and largely responsible for its psychoactive effects (National Cancer Institute [NCI] 2014). Cannabis may be taken by mouth or inhaled. When taken by mouth (in baked products or as an herbal tea), THC is processed by the liver, making an additional psychoactive chemical. When cannabis is smoked and inhaled, cannabinoids quickly enter the bloodstream. The additional psychoactive chemical is produced in smaller amounts than when taken by mouth (NCI 2014). Medical marijuana refers to the use of cannabis and its constituents as a physician-recommended form of medicine or herbal therapy. Marijuana or marijuana derived products are being used for a number of medical conditions, including AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis (MS), and cancer and chemotherapy-induced nausea and vomiting (CINV) (FDA 2014a). While marijuana has been used for medicinal purposes for thousands of years, the risks and benefits of its medicinal use have been studied insufficiently (Wang 2008). For example, the most rigorous studies have reported adverse events associated with its recreational use. Extrapolating results of recreational cannabis use cannot be expected to occur with medical marijuana use. The amounts used, the existence of comorbidities, and the methods of drug delivery may differ between the two populations. Therefore, medical marijuana should be evaluated separately (Wang 2008). Regulation: In the United States, marijuana is a Schedule I controlled substance requiring special licensing for its use; it has no recognized medical use, carries a high risk of dependency, and is illegal to use and distribute (21 U.S.C. 801). FDA is responsible for the approval and marketing of drugs for medical use, including controlled substances (FDA 2014a). Several states have either passed laws that remove state restrictions on the medical use of marijuana and its derivatives, or are considering doing so. To date, FDA has not approved a marketing application for a drug product containing or derived from botanical marijuana, and has not found any such product to be safe and effective for any indication (FDA 2014a). FDA has approved two drugs that have synthetic THC as an active ingredient. Dronabinol, marketed as Marinol (AbbVie Inc., North Chicago, IL) and Syndros (Insys Therapeutics, Inc., Chandler, AZ), is approved for anorexia associated with weight loss in patients with AIDS and for nausea and vomiting 2

3 associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Nabilone is marketed as Cesamet (Valeant Pharmaceuticals, Aliso Viejo, CA), which has a chemical structure similar to THC and is approved for CINV in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol and nabilone are administered orally in capsule form (FDA 2014a). In April 2014, FDA granted Fast-Track designation to the investigational drug product Sativex (GW Pharmaceuticals, United Kingdom) (FDA 2014b). Sativex is composed primarily of cannabidiol (CBD) and THC and administered as a metered dose oromucosal spray for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. Sativex is currently in Phase III clinical trials for this indication. On June 6, 2014, FDA granted Fast-Track designation to Epidiolex (GW Pharmaceuticals, United Kingdom), for treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. Fast-Track designation provides for more frequent meetings and communications with FDA to discuss the drug s development plan and ensures collection of appropriate data needed to support drug approval, including the design of the proposed clinical trials and use of biomarkers (FDA 2014b). Medical uses of smoked, inhaled, ingested, or sprayed botanical marijuana is the focus of this clinical policy. This policy excludes Marinol, Cesamet, Sativex, or Epidiolex for clinical use, and marijuana for recreational use. Searches AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre 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 September 7, Search terms were: "Cannabis"(MeSH) and "Medical Marijuana"(MeSH). 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. 3

4 Findings We identified 10 systematic reviews for this policy. The systematic reviews examined the safety and effectiveness of cannabis and cannabinoids for several medical uses. These uses include wasting and cachexia in patients with HIV/AIDS, pain and spasticity in patients with amyotrophic lateral sclerosis/motor neuron disease, antiemesis for CINV, ataxia associated with MS, dyskinesia in Parkinson s disease, intraocular pressure in glaucoma, and symptoms of asthma. We found no economic analyses or evidence-based guidelines for this policy. The evidence is insufficient to support the use of botanical (smoked) marijuana for medical use. Most of the available evidence from randomized controlled trials (RCTs) with placebo controls was intended to assess the safety and efficacy of oral delta-9-thc in patients who had failed conventional therapies. Relatively few RCTs have evaluated the safety and efficacy of smoked marijuana for medical use. All of the studies involved small numbers of patients and were of short duration, lasting from several days to weeks, depending on the condition being treated. Studies carried out in the 1970s and 1980s compared medical marijuana to outdated standards of care and lacked measurement of benefits and harms associated with long-term inhaled marijuana use. The paucity and poor quality of the evidence make it difficult to compare botanical marijuana with current pharmaceuticals that have received regulatory approval under more rigorous experimental conditions. Marijuana contains a variable mixture of poorly defined biologically active compounds and the level of THC fluctuates significantly between samples, making it impossible to quantify by inspection. The concept of a predictable, quantifiable "dose" is a fundamental principle of medical therapy, but few (if any) of the prescribing criteria of medical pharmacology can be met in the case of smoked or ingested botanical marijuana (Fisher 2002). Our searches and a report by the Canadian Agency for Drugs and Technologies in Health (CADTH) found no evidence-based guidelines supporting the use of medical marijuana for specific medical conditions (CADTH 2013). Practitioners recognized that marijuana might have treatment potential for certain medical symptoms. However, they are not uniform in their support for, or opposition to, medical marijuana. Several major medical organizations in the United States have not endorsed the use of medical marijuana, but most have called for expedited clinical research to discern its safety, dosage, and effectiveness, particularly of cannabinoids rather than smoked marijuana (American Academy of Child and Adolescent Psychiatry 2012, American College of Physicians 2008, American Academy of Pediatrics 2004). Policy updates: In 2015, we identified one new systematic review for this update (Koppel 2014). The results of the review do not change the previous conclusions. Therefore, no changes to the policy are warranted. 4

5 In 2016, we identified two new evidence-based guidelines, four systematic review and meta-analyses, and one large epidemiologic study for this policy. Guidelines by the American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Neurology (AAN) cite the limited evidence supporting the safety and efficacy of medical cannabis use in pregnant women and persons with MS, respectively (ACOG 2015, Yadav 2014). Both guidelines highlight concerns for known adverse effects and knowledge gaps in standardized administration of cannabis, long-term effects, and interactions with other drug treatments. Results of three new systematic reviews and meta-analyses suggest botanical cannabis offers short-term relief of chronic neuropathic pain with non-serious side effects when used in conjunction with traditional analgesics, but comparisons to treatment alternatives are lacking, as are long-term safety and effectiveness data (Andreae 2015, Deshpande 2015, Whiting 2015). In addition, Whiting (2015) found low to moderate evidence that botanical cannabis improved CINV, weight gain in HIV infection, sleep disorders, and Tourette syndrome, but also increased the risk of adverse effects, including some serious adverse events such as psychosis. Gurney (2015) found low-quality evidence supporting an association between cannabis use and increased risk of developing non-seminoma testicular germ cell cancer, particularly among current users, at least weekly users and chronic users (> 10 years), compared to those who never used cannabis. Finally, a large epidemiologic survey of 34,653 adults aged 18 years in the United States found cannabis use was significantly associated with an increased risk for several substance use disorders (SUDs). Based on the new evidence, the benefits of botanical cannabis for medical use do not outweigh the risks of adverse events for any indication. According to FDA, additional research of its safety and effectiveness should be registered by the Drug Enforcement Administration and conducted under an FDA investigational new drug application and research protocol using medical grade cannabis supplied by the National Institute on Drug Abuse (FDA 2016b). Summary of clinical evidence: Citation Blanco (2016) Content, Methods, Recommendations Cannabis Use and Risk of Psychiatric Disorders A nationally representative sample of 34,653 U.S. adults aged 18 years interviewed three years apart in the National Epidemiologic Survey on Alcohol and Related Conditions (wave 1, ; wave 2, ) using multiple regression analysis and propensity score matching used to estimate association between cannabis use at wave 1 and incidence and prevalence of Alcohol Use Disorder and Associated Disabilities Interview Schedule-DSM-IV psychiatric disorders at wave 2. Within the general population, cannabis use in wave 1 was significantly associated with an increased risk for several substance use disorders (SUDs) in wave 2: - Any SUD (odds ratio [OR], 95% confidence interval): 6.2 ( ). - Any alcohol use disorder: 2.7 ( ). - Any cannabis use disorder: 9.5 ( ). - Any other drug use disorder: 2.6 ( ). - Nicotine dependence: 1.7 ( ). - But not mood disorder (1.1, ) or anxiety disorder (0.9, ). 5

6 Citation ACOG Committee Opinion (2015) Guideline for marijuana use during pregnancy and lactation Andreae (2015) Inhaled cannabis for chronic neuropathic pain Deshpande (2015) Medical marijuana for chronic non-cancer pain (CNCP) Gurney (2015) Content, Methods, Recommendations There are no FDA-approved indications, contraindications, safety precautions, or recommendations regarding its use during pregnancy and lactation. There are no standardized formulations, dosages, or delivery systems. Obstetrician gynecologists should be discouraged from prescribing or suggesting the use of marijuana for medicinal purposes during preconception, pregnancy, and lactation. Pregnant women or women contemplating pregnancy should be encouraged to discontinue use of medical marijuana in favor of alternative therapies with better pregnancy-specific safety data. High-quality studies regarding the effects of marijuana and other cannabis products on pregnancy and lactation are needed. A meta-analysis of individual patient data from five RCTs (178 participants with chronic neuropathic pain with 405 observed responses) following patients for days to weeks. Inhaled cannabis may provide short-term pain relief for one in five to six patients. Results limited by small number of studies and participants, the short follow up, shortcomings in allocation concealment, and considerable attrition. Pragmatic trials are needed to evaluate the long-term benefits and risks. Systematic review of six RCTs (226 total patients) that assessed medical marijuana in CNCP with other concomitant analgesics including opioids and anticonvulsants. Overall quality: moderate. All limited by lack of masking, short duration (maximum of 5 days), variability in dosing and strength of delta-9-thc, and lack of functional outcomes. Three of six trials reported clinically meaningful pain reduction using low-dose (< 34 mg/d) medical marijuana in refractory neuropathic pain of moderate severity in conjunction with traditional analgesics with non-serious side effects. Functional assessment and quality of life domains not reported. Comparisons to other treatment alternatives are lacking, and long-term psychoactive and neurocognitive effects remain unknown. Evidence does not support generalizing the use of medical marijuana to all CNCP conditions. Cannabis exposure and risk of testicular cancer Systematic review and meta-analysis of three case-control studies (719 total cases, 1,419 controls) conducted in the U.S. in the 1990s. Overall quality: low with a high risk of bias. Limited by low and differential response rates between groups, non-validated self-reported use, and lack of blinding. Current use of cannabis (pooled summary OR: 1.62, 95 % CI ), using cannabis at least weekly (OR: 1.92, 95 % CI ) and long duration (> 10 years) of cannabis use (OR: 1.50, 95 % CI ) are all associated with increased risk of developing a non-seminoma testicular germ cell tumor compared to those who never used cannabis. Evidence of a relationship between cannabis use and the development of seminoma tumors was inconclusive. 6

7 Citation Whiting (2015) Cannabinoids for medical use: CINV, appetite stimulation in HIV/AIDS, chronic pain, spasticity due to multiple sclerosis or paraplegia, depression, anxiety disorder, sleep disorder, psychosis, glaucoma, or Tourette syndrome Koppel (2014) Content, Methods, Recommendations Systematic review and meta-analysis of 79 RCTs (6,462 total participants). Overall quality: low to moderate. Only four were judged at low risk of bias. Mostly placebo-controlled. Most trials showed a non-statistically significant improvement in symptoms associated with cannabinoids. Moderate-quality evidence supports cannabinoid use for treatment of chronic pain and spasticity. Low-quality evidence supports cannabinoid use improved CINV, weight gain in HIV infection, sleep disorders, and Tourette syndrome. Cannabinoids were associated with an increased risk of short-term adverse events (AE), including serious AEs. Common AEs included dizziness, dry mouth, nausea, fatigue, somnolence, euphoria, vomiting, disorientation, drowsiness, confusion, loss of balance, and hallucination. MS, epilepsy, and movement disorders. Systematic review of 34 studies (eight RCTs) (1948 November 2013) including two controlled studies of smoked marijuana. For spasticity, central pain or painful spasms in MS or seizure disorders, smoked marijuana is of unclear efficacy. Cognitive impairment is a significant adverse effect with smoked marijuana use. Comparative effectiveness to other drugs needs to be studied. Yadav (2014) for the American Academy of Neurology Evidence-based guideline: complementary and alternative medicine in multiple sclerosis Lutge (2013) Guideline included two non-randomized controlled trials of inhaled cannabis use (57 total patients with mixed types of MS). Conflicting findings with respect to short-term reductions in spasticity, pain, measures of posture and balance and cognitive performance. Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs. non-standardized cannabis extracts and overall quality control/non-regulation. Interaction with MS disease-modifying therapies is unknown. Insufficient evidence to recommend for or against cannabis use. Cochrane review HIV/AIDS Seven RCTs (eight publications) of effects of cannabis (in its natural or artificially produced form) either smoked or ingested, on morbidity or mortality of patients infected with HIV. Overall quality: low. Short duration (21 days to 84 days); small numbers; allocation concealment variable but only dronabinol was expected to be more easily blinded; variable outcomes measured for change in weight, body fat, appetite, caloric intake, nausea and vomiting, performance and mood. Insufficient evidence for the efficacy and safety of cannabis and cannabinoids in persons with HIV/AIDS. Long-term data showing a sustained effect on AIDS-related morbidity, mortality and safety in patients on effective antiretroviral therapy, have yet to be presented. Brettschneider (2013) Cochrane review Amyotrophic lateral No RCTs identified for palliative treatment of pain in ALS or MND. 7

8 Citation sclerosis (ALS)/motor neuron disease (MND) Ashworth (2012) Cochrane review ALS/MND Krishnan (2009) Content, Methods, Recommendations No RCTs identified for use of cannabis or derivatives for treating spasticity in patients with MND. Cochrane review Dementia Systematic review of one RCT of poor quality and reporting regarding the effect of cannabinoids on disturbed behavior in dementia, or in the treatment of other symptoms of dementia. Insufficient evidence. Wang (2008) Adverse effects No RCTs of smoked medical cannabis were included because no quantifiable adverse event data were available. Machado-Rocha (2008) CINV Mills (2007) No RCTs of smoked cannabis were identified. Ataxia in MS Ten RCTs of various treatments, including cannabis, were identified. Insufficient evidence. Standardized, well-validated measures of ataxia and tremor are needed along with larger, well-designed RCTs. Chung (2006) Parkinson s disease Only one small RCT included comparing cannabis with placebo; cannabis had no therapeutic effect on L-dopa-induced dyskinesia, overall Unified Parkinson's Disease Rating Scale or PDQ-39. Insufficient evidence to evaluate efficacy and safety. Further studies with improved trial design and reporting, assessment of cost-effectiveness and qualitative data are warranted to evaluate impact on quality of life. Hayes (2008) Multiple indications Included studies published through 2002 of CINV, anorexia associated with AIDS or cancer, glaucoma, MS and generalized pain. Overall assessment: low quantity and quality with high risk of bias. Acute effects of smoking marijuana are common and include impaired memory and motor coordination, slower reaction time, altered peripheral vision and impaired driving. Large doses or use by an inexperienced individual can lead to symptoms such as anxiety, panic or depression. Anecdotal reports of an acute panic reaction, delirium, acute paranoid state or mania. In addition, there are risks of chronic smoking to the respiratory and immune systems. These and other potential effects (i.e., neurological, endocrine and cardiovascular) have not been thoroughly examined, especially in the elderly or in those with chronic disease. However, the therapeutic index for Cannabis is higher than for most drugs 8

9 Citation Fisher (2002) Content, Methods, Recommendations (40,000:1). Insufficient evidence. Multiple indications Eight interventional studies and 16 harm studies included for CINV, glaucoma, MS and spasticity, analgesia and asthma. Overall quality: low with high degree of bias. Long-term effects and safety are undetermined. Some comparators do not reflect current practice standards. Insufficient evidence. Glossary Cannabinoid A class of diverse chemical compounds that act on cannabinoid receptors on cells that repress neurotransmitter release in the brain. These receptor proteins include the endocannabinoids (produced naturally in the body by humans and animals), phytocannabinoids (found in cannabis and some other plants) and synthetic cannabinoids (manufactured chemically). Cannabis Commonly known as marijuana and by numerous other names, is a preparation of the cannabis herb plant. Cannabis is often consumed for its psychoactive and physiological effects, which can include heightened mood or euphoria, relaxation and an increase in appetite. Marijuana See cannabis. Schedule I controlled substances Per Section 812 of the Controlled Substances Act (21 U.S.C. 801), drugs that have the following characteristics according to the United States Drug Enforcement Agency: The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical treatment use in the United States. There is a lack of accepted safety for use of the drug or substance under medical supervision. No prescriptions may be written for Schedule I substances, as they are not readily available for clinical use. Tetrahydrocannabinol (THC) Its main isomer, ( )-trans-δ 9 -tetrahydrocannabinol ( [6aR,10aR]-delta-9- tetrahydrocannabinol), is the principal psychoactive cannabinoid of the cannabis plant. References Professional society guidelines/other: 9

10 ACOG Committee opinion No. 637: marijuana use during pregnancy and lactation. Obstet Gynecol. 2015; 126(1): Medical marijuana policy statement. American Academy of Child and Adolescent Psychiatry website. spx. Accessed September 8, Rapid response report: reference list. The use of medical marijuana: guidelines and recommendations. Canadian Agency for Drugs and Technologies in Health (CADTH) website. Accessed September 8, Supporting research into the therapeutic role of marijuana. A position paper of the American College of Physicians. American College of Physicians website. Accessed September 8, Technical report: legalization of marijuana: potential impact on youth. Pediatrics. 2004; 113(6). American Academy of Pediatrics, Committee on Substance Abuse and Committee on Adolescence website. Accessed September 8, Yadav V, Bever C, Jr., Bowen J, et al. Summary of evidence-based guideline: complementary and alternative medicine in multiple sclerosis: report of the guideline development subcommittee of the American Academy of Neurology. Neurology. 2014; 82(12): Peer-reviewed references: 21 U.S.C Controlled Substances Act. Andreae MH, Carter GM, Shaparin N, et al. Inhaled Cannabis for Chronic Neuropathic Pain: A Metaanalysis of Individual Patient Data. J Pain. 2015; 16(12): Ashworth Nigel L, Satkunam LE, Deforge D. Treatment for Spasticity in Amyotrophic Lateral Sclerosis/Motor Neuron Disease. Cochrane Database Syst Rev. 2012(2): CD Blanco C, Hasin DS, Wall MM, et al. Cannabis use and risk of psychiatric disorders: prospective evidence from a us national longitudinal study. JAMA Psychiatry. 2016; 73(4): Brettschneider J, Kurent J, Ludolph A. Drug Therapy for Pain in Amyotrophic Lateral Sclerosis or Motor Neuron Disease. Cochrane Database Syst Rev. 2013(6): CD

11 Cannabis and Cannabinoids (PDQ ). Overview. National Cancer Institute website. Accessed September 7, Chung V, Liu L, Bian Z, et al. Efficacy and safety of herbal medicines for idiopathic Parkinson's disease: A systematic review (structured abstract). Movement Disorders. 2006; 21(10): Deshpande A, Mailis-Gagnon A, Zoheiry N, Lakha SF. Efficacy and adverse effects of medical marijuana for chronic noncancer pain: Systematic review of randomized controlled trials. Can Fam Physician. 2015; 61(8): e FDA. News & Events. FDA and Marijuana: Questions and Answers. FDA website. Accessed September 7, (a) FDA. News & Events. Researching the Potential Medical Benefits and Risks of Marijuana. FDA website. Accessed September 7, (b) Fisher B, Johnston D, Leake P for the Medical Services Workers' Compensation Board Alberta. Marijuana for medicinal purposes: An evidence-based assessment. June, Workers' Compensation Board of British Columbia website: Accessed September 8, Gurney J, Shaw C, Stanley J, Signal V, Sarfati D. Cannabis exposure and risk of testicular cancer: a systematic review and meta-analysis. BMC Cancer. 2015; 15: 897. Hayes Inc., Hayes Medical Technology Report. Therapeutic Uses of Smoked Cannabis Sativa and Isolated Cannabinoids. Lansdale, Pa. Hayes Inc.; 2002 [Archived]. Koppel BS, Brust JC, Fife T, et al. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014; 82(17): Krishnan S, Cairns R, Howard R. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2009(2): CD Lutge EE, Gray A, Siegfried N. The medical use of cannabis for reducing morbidity and mortality in patients with HIV/AIDS. Cochrane Database Syst Rev. 2013; 4: CD Machado Rocha FC, Stefano SC, De Cassia Haiek R, Rosa Oliveira LM, Da Silveira DX. Therapeutic use of cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: systematic review and meta-analysis. Eur J Cancer Care (Engl) Sep; 17(5):

12 Mills RJ, Yap L, Young CA. Treatment for Ataxia in Multiple Sclerosis. Cochrane Database Syst Rev. 2007(1): CD Wang T, Collet JP, Shapiro S, Ware MA. Adverse Effects of Medical Cannabinoids: A Systematic Review. CMAJ: Canadian Medical Association Journal. 2008; 178(13): Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: A systematic review and metaanalysis. Jama. 2015; 313(24): Clinical trials: Searched ClinicalTrials.gov on September 8, 2016, using terms: Recruiting cannabis OR marijuana OR marihuana NOT (Sativex OR syndros or marinol OR dronabinol OR nabilone OR Cesamet) United States. Seventy-three studies were found; six trials were relevant. Cannabidiol (CBD) and Pediatric Epilepsy. ClinicalTrials.gov website. Accessed September 8, Cannabidiol Treatment in Patients With Early Psychosis. ClinicalTrials.gov website. Accessed September 8, Cannabis for Spasticity in Multiple Sclerosis. ClinicalTrials.gov website. Accessed September 8, Colorado Marijuana Users Health Cohort. ClinicalTrials.gov website. Accessed September 8, The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy. ClinicalTrials.gov website. Accessed September 8, Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease. ClinicalTrials.gov website. Accessed September 8, CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes 12

13 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 accordingly. CPT Code Description Comment No codes ICD-10 Code Description Comment No codes HCPCS Level ll Codes No codes Description Comment 13

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