Prior Authorization Review Panel MCO Policy Submission A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review. Plan: Aetna Better Health Submission Date: 04/02/2018 Policy Number: 0135 Effective Date: Revision Date: 03/30/2018 Policy Name: Acupuncture Type of Submission – Check all that apply:  New Policy Revised Policy*  Annual Review – No Revisions *All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below: CPB 0135 Acupuncture This CPB has been revised to state that acupuncture is considered experimental and investigational for Alzheimer’s disease, dysmenorrhea, neuropathic pain, peptic ulcer, and vascular dementia. Name of Authorized Individual (Please type or print): Signature of Authorized Individual: Dr. Bernard Lewin, M.D. Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html (https://www.aetna.com/) Number: 0135 Policy *Please see amendment for P ennsylvania M edicaid a t t he e nd Last Review 03/30/2018 of t his C PB. Effective: 07/19/1996 Next Review: 01/24/2019 Note: Most Aetna plans limit coverage of acupuncture to when it is used in a lieu of other anesthesia for a surgical or dental Review History procedure covered under the health benefits plan, and the health care provider administering it is a legally qualified Definitions physician practicing within the scope of his/her license. Some other plans may extend coverage of acupuncture for medically necessary indications, but only when administered by a health care provider who is a legally qualified physician practicing within the scope of his/her license. Please check benefit plan descriptions for details. Clinical Policy Bulletin Notes Aetna considers needle acupuncture (manual or electroacupuncture) medically necessary for any of the following indications: Chronic (minimum 12 weeks duration) neck pain; or Chronic (minimum 12 weeks duration) headache; or Low back pain; or Nausea of pregnancy; or Pain from osteoarthritis of the knee or hip (adjunctive 1 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html therapy); or Post‐operative and chemotherapy‐induced nausea and vomiting; or Post‐operative dental pain; or Temporomandibular disorders (TMD). Maintenance treatment, where the member's symptoms are neither regressing or improving, is considered not medically necessary. If no clinical benefit is appreciated after four weeks of acupuncture, then the treatment plan should be reevaluated. Further acupuncture treatment is not considered medically necessary if the member does not demonstrate meaningful improvement in symptoms. Aetna considers acupuncture experimental and investigational for all other indications, including but not limited to any of the following conditions, because there is inadequate scientific research assessing the efficacy of acupuncture compared with placebo, sham acupuncture or other modalities of treatment in these conditions: 2 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html Acne Intra‐cerebral hemorrhage Addiction Irritable bowel syndrome AIDS Menopause‐associated Allergies vasomotor symptoms Alzheimer’s disease Menopausal hot flashes Amblyopia Menstrual Asthma cramps/dysmenorrhea Attention deficit hyperactivity Multiple sclerosis Mumps disorder (ADHD) Myofascial pain Autism spectrum disorders Myopia Bell's palsy Neck pain/cervical spondylosis Benign prostatic hypertrophy Neuropathic pain Breast cancer‐related hot Nocturnal enuresis flashes Obesity / weight reduction Burning mouth syndrome Painful neuropathies Cancer‐induced bone pain Parkinson's disease Cancer‐related dyspnea Parkinson's disease‐related Cancer‐related fatigue fatigue Carpal tunnel syndrome Peptic ulcer Cerebral palsy Peripheral arterial disease (e.g., Chemotherapy‐induced intermittent claudication) leukopenia Chemotherapy‐ Phantom leg pain induced neuropathic pain Plantar fasciitis Chronic pain syndrome (e.g., Polycystic ovary syndrome RSD, facial pain) Post‐herpetic neuralgia Chronic obstructive pulmonary Post‐operative ileus Post‐ disease (COPD) stroke shoulder pain Chronic constipation Post‐traumatic stress disorder Chronic fatigue syndrome Pruritus Cognitive impairment Psoriasis Diabetic gastroparesis Psychiatric disorders (e.g., Diabetic peripheral neuropathy anxiety, depression, and Dry eyes schizophrenia) Raynaud’s Dysmenorrhea disease pain Respiratory Endometriosis pain disorders Rheumatoid Epilepsy arthritis Rhinitis Erectile dysfunction 3 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html Sensorineural deafness Shoulder pain (e.g., bursitis) Smoking cessation Spasticity Fibrotic contractures after stroke Stroke Glaucoma rehabilitation (e.g., Heart failure dysphagia) Hypertension Tennis elbow / epicondylitis Hypoxic ischemic Tension headache encephalopathy Induction of labor Infantile colic Tinnitus Infantile diarrhea Urinary incontinence Infertility (e.g., to assist oocyte Uterine fibroids retrieval and embryo transfer Va scular dementia during IVF treatment cycle) Xerostomia Inflammatory bowel diseases Whiplash (Crohn's disease and ulcerative colitis) Insomnia (including cancer‐ Aetna considers acupuncture point injection (also known as acupoint injection therapy, biopuncture) experimental and investigational for the following conditions (not an all‐inclusive list) because the effectiveness of this approach has not been established: Amyotrophic lateral sclerosis. Cancer‐related pain Cervical spondylosis Chronic daily headache Dysmenorrhea (menstrual pain) Lateral elbow pain (tennis elbow). Aetna considers dry needling experimental and investigational because of inadequate evidence of its effectiveness. Background 4 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html Acupuncture as a therapeutic intervention is widely practiced in the United States. The general theory of acupuncture is based on the premise that there are patterns of energy flow (Qi) through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin. Findings from basic research have begun to elucidate the mechanisms of action of acupuncture, including the release of opioids and other peptides in the central nervous system and the periphery and changes in neuroendocrine function. While there have been many studies of its potential usefulness, the vast majority of papers studying acupuncture in the biomedical literature consist of case reports, case series, or intervention studies. One of the difficulties with drawing conclusions from the existing literature is that the term acupuncture is used to describe a variety of treatments that differ in many important aspects according to level of effect (e.g., local, segmental, generalized) and type of acupuncture treatment (e.g., manual versus electrical acupuncture). Many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups, and by absence of studies comparing acupuncture with conventional biomedical treatments. Some factors needing investigation include frequency, number, and duration of treatments, depth of puncture, number of acupuncture points used, combination with other therapies, sample size, setting, blinding factors, and needle size. Be that as it may, promising results have emerged on the efficacy of acupuncture in adult post‐operative and chemotherapy nausea and vomiting and in postoperative dental pain. There is insufficient evidence of the efficacy of acupuncture as a treatment for fibromyalgia. The U.S. Department of Health and Human Services, Public Health Service, Agency for Healthcare Research and Quality (AHRQ) performed a technology 5 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html assessment (2003) on Acupuncture for the Treatment of Fibromyalgia; it stated that "[a]t this time, therefore, there is insufficient evidence to conclude that acupuncture has efficacy for the treatment of fibromyalgia." There is evidence to support the use of acupuncture in migraine. In a large randomized controlled study (n = 401), Vickers et al (2004) examined the effects of a policy of "use acupuncture" on headache (predominantly migraine), health status, days off sick, and use of resources in patients with chronic headache compared with a policy of "avoid acupuncture". Patients were randomly allocated to receive up to 12 acupuncture treatments over 3 months or to a control intervention offering usual care. Headache score, SF‐36 health status, and use of medication were assessed at baseline, 3, and 12 months. Use of resources was assessed every 3 months. Headache score at 12 months, the primary end point, was lower in the acupuncture group (16.2, SD 13.7, n = 161, 34 % reduction from baseline) than in controls (22.3, SD 17.0, n = 140, 16 % reduction from baseline). The adjusted difference between means is 4.6 (95 % confidence interval [CI]: 2.2 to 7.0; p = 0.0002). This result is robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year (8 to 38). SF‐36 data favored acupuncture, although differences reached significance only for physical role functioning, energy, and change in health. Compared with controls, patients randomized to acupuncture used 15 % less medication (p = 0.02), made 25 % fewer visits to general practitioners (p = 0.10), and took 15 % fewer days off sick (p = 0.2). The authors concluded that acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. The results of the study by Vickers et al (2004) are in agreement with recent findings of Allais et al (2003) who reported that acupuncture is effective in reducing the frequency of migraine attacks as well as those by Linde et al (2009) who reported that acupuncture was more effective than a placebo injection in the 6 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html early treatment of an acute migraine attack. Facco and colleagues (2008) examined the effectiveness of a true acupuncture treatment according to traditional Chinese medicine (TCM) in migraine without aura, comparing it to a standard mock acupuncture protocol, an accurate mock acupuncture healing ritual, and untreated controls. A prospective, randomized, controlled study was performed in 160 patients suffering from migraine without aura, assessed according to the ICD‐10 classification. Patients were divided into the following 4 groups: (i) group TA, treated with true acupuncture (according to TCM) plus rizatriptan; (ii) group RMA, treated with ritualized mock acupuncture plus rizatriptan; (iii) group SMA, treated with standard mock acupuncture plus rizatriptan; and (iv) group R, without prophylactic treatment with relief therapy only (rizatriptan). The MIDAS Questionnaire was administered before treatment (T0), at 3 (T1) and 6 months (T2) from the beginning of treatment, and the MIDAS Index (MI) was calculated. Rizatriptan intake was also checked in all groups of patients at T0, T1, and T2. Group TA and RMA were evaluated according to TCM as well; then, the former was submitted to true acupuncture and the latter to mock acupuncture treatment resembling the same as TA. The statistical analysis was conducted with factorial ANOVA and multiple tests with a Bonferroni adjustment. A total of 127 patients completed the study (33 dropouts): 32 belonged to group TA, 30 to group RMA, 31 to group SMA, and 34 to group R. Before treatment the MI (T(0)) was moderate‐to‐severe with no significant inter‐group differences. All groups underwent a decrease of MI at T(1) and T(2), with a significant group difference at both T(1) and T(2) compared to T(0) (p < 0.0001). Only TA provided a significant improvement at both T(1) and T(2) compared to R (p < 0.0001). Patients in the RMA group underwent a transient improvement of MI at T(1). The intake of rizatriptan paralleled the MI in all groups. The authors concluded that TA was the only treatment able to provide a steady outcome improvement in comparison to the use of only rizatriptan, while RMA showed a transient placebo effect at T1. 7 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html There is insufficient evidence for acupuncture as a treatment for insomnia. Sok and colleagues (2003) stated that further investigation, using a randomized clinical trial design, is necessary to determine the effectiveness of acupuncture for the treatment of insomnia. Furthermore, additional work is also needed to promote the long‐term therapeutic effects of acupuncture and to compare it with other therapies for insomnia. There is limited and insufficient evidence for acupuncture for treatment of dysmenorrhea, infertility and other women's reproductive indications. White (2003) performed a review of controlled studies of acupuncture for women's reproductive health care. The author concluded that in view of the small number of studies and their variable quality, doubt remains about the effectiveness of acupuncture for gynecological conditions. Acupuncture appears promising for dysmenorrhea and infertility, and further studies are justified. There is insufficient evidence for acupuncture to improve outcomes of in vitro fertilization. In a Cochrane review, Cheong et al (2008) determined the effectiveness of acupuncture in the outcomes of assisted reproductive treatment (ART). Randomized controlled trials (RCTs) of acupuncture for couples who were undergoing ART comparing acupuncture treatment alone or acupuncture with concurrent ART versus no treatment, placebo or sham acupuncture plus ART for the treatment of primary and secondary infertility were selected. Women with medical illness deemed contra‐indications for ART or acupuncture were excluded. A total of 16 RCTs that involved acupuncture and assisted conception were identified; 13 trials were included in the review and 3 were excluded. Quality assessment and data extraction were performed independently by 2 review authors. Meta‐analysis was performed using odds ratio (OR) for dichotomous outcomes. The outcome measures were live birth rate, clinical ongoing pregnancy rate, miscarriage rate, and any reported side effects of treatment. There is evidence of benefit when acupuncture is performed on the day of embryo transfer (ET) on the live birth rate (OR 1.89, 95 % CI: 8 of 110 03/27/2018, 11:06 AM Acupuncture - Medical Clinical Policy Bulletins | Aetna http://qawww.aetna.com/cpb/medical/data/100_199/0135_draft.html 1.29 to 2.77) but not when it is performed 2 to 3 days after ET (OR 1.79, 95 % CI: 0.93 to 3.44). There is no evidence of benefit on pregnancy outcomes when acupuncture is performed around the time of oocyte retrieval. The authors concluded that acupuncture performed on the day of ET shows a beneficial effect on the live birth rate; however, with the present evidence this could be attributed to placebo effect and the small number of women included in the trials. They stated that acupuncture should not be offered during the luteal phase in routine clinical practice until further evidence is available from sufficiently powered RCTs. This is in agreement with the observation of El‐Toukhy et al (2008) who stated that currently available literature does not provide sufficient evidence that adjuvant acupuncture improves in vitro fertilization clinical pregnancy rate. In addition, Ng et al (2008) noted that although acupuncture has gained increasing popularity in the management of sub‐fertility, its effectiveness has remained controversial. There is some evidence to support the use of acupuncture for treatment of hip and knee osteoarthritis. An earlier AHRQ technology assessment (2003) on Acupuncture for Osteoarthritis concluded that "The currently available evidence is insufficient to determine whether acupuncture has a specific beneficial effect in osteoarthritis." However, a Cochrane review of acupuncture for peripheral joint osteoarthritis (Manheimer et al, 2010) concluded that sham‐controlled trials show statistically significant benefits; the authors stated, however, that these benefits are small, do not meet the authors' pre- defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. The authors found that waiting list‐controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects. Acupuncture has also been employed to relieve pain and improve movement in people with osteoarthritis (OA) of the knee. In the largest clinical study of acupuncture reported to 9 of 110 03/27/2018, 11:06 AM