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CHELATION THERAPY for NON-OVERLOAD CONDITIONS Policy Number: REHABILITATION 015.25 T1 Effective Date: May 1, 2018

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CHELATION THERAPY for NON-OVERLOAD CONDITIONS Policy Number: REHABILITATION 015.25 T1 Effective Date: May 1, 2018 UnitedHealthcare® Oxford Clinical Policy CHELATION THERAPY FOR NON-OVERLOAD CONDITIONS Policy Number: REHABILITATION 015.25 T1 Effective Date: May 1, 2018 Table of Contents Page Related Policy INSTRUCTIONS FOR USE .......................................... 1 Omnibus Codes CONDITIONS OF COVERAGE ...................................... 1 BENEFIT CONSIDERATIONS ...................................... 1 COVERAGE RATIONALE ............................................. 2 APPLICABLE CODES ................................................. 2 DESCRIPTION OF SERVICES ...................................... 3 CLINICAL EVIDENCE ................................................. 3 U.S. FOOD AND DRUG ADMINISTRATION .................... 5 REFERENCES ........................................................... 6 POLICY HISTORY/REVISION INFORMATION ................. 7 INSTRUCTIONS FOR USE This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. CONDITIONS OF COVERAGE Applicable Lines of Business/ Products This policy applies to Oxford Commercial plan membership. Benefit Type General benefits package Referral Required No (Does not apply to non-gatekeeper products) Authorization Required Yes (Precertification always required for inpatient admission) Precertification with Medical Director Review Required No Applicable Site(s) of Service Outpatient, Inpatient, Skilled Nursing Facilities, Home (If site of service is not listed, Medical Director review is required) BENEFIT CONSIDERATIONS Before using this policy, please check the member specific benefit plan document and any federal or state mandates, if applicable. Chelation Therapy for Non-Overload Conditions Page 1 of 7 UnitedHealthcare Oxford Clinical Policy Effective 05/01/2018 ©1996-2018, Oxford Health Plans, LLC Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage. COVERAGE RATIONALE Chelation for heavy metal toxicity and overload conditions (e.g., iron, copper, lead, aluminum) is proven and/or medically necessary and not addressed in this policy. Chelation therapy is unproven and/or not medically necessary for treating "mercury toxicity" from dental amalgam fillings. Randomized controlled trials do not identify a causal association between amalgam fillings and various systemic symptoms and disorders attributed to mercury. Chelation therapy is unproven and/or not medically necessary for treating chronic, progressive diseases (not involving heavy metal toxicity or overload conditions) and other disorders including but not limited to: Alzheimer's disease Apoplectic coma Autism spectrum disorder Cancer Cardiovascular disease Cholelithiasis Chronic fatigue syndrome Chronic renal insufficiency Defective hearing Diabetes Diabetic ulcer Gout Erectile dysfunction Multiple sclerosis Osteoarthritis Osteoporosis Parkinson's disease Raynaud's disease Renal calculus Rheumatoid arthritis Schizophrenia Scleroderma Snake venom poisoning Varicose veins Vision disorders (glaucoma, cataracts, etc.) Much of the evidence supporting chelation treatment for other chronic progressive disease is based on testimonials and single-case studies. Thus, there still is no scientific evidence that demonstrates any benefit from this form of therapy. APPLICABLE CODES The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non- covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies may apply. HCPCS Code Description J3490 Unclassified drugs Chelation Therapy for Non-Overload Conditions Page 2 of 7 UnitedHealthcare Oxford Clinical Policy Effective 05/01/2018 ©1996-2018, Oxford Health Plans, LLC HCPCS Code Description M0300 IV chelation therapy (chemical endarterectomy) Home infusion therapy, chelation therapy; administrative services, professional S9355 pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem CPT® is a registered trademark of the American Medical Association DESCRIPTION OF SERVICES Chelation therapy involves the administration of naturally occurring or chemically designed molecules to bind and excrete a specific toxin in the body. The specific medication, route, method and site of administration of the chelating agent vary depending on the specific agent used, the level of toxicity, and other clinical indications. Heavy metal toxicity most often treated with chelation therapy includes that caused by iron, copper, lead, aluminum, and mercury. Non-Overload Conditions: Chelation therapy has been proposed as a treatment for a variety of Non-Overload Conditions in which the removal of heavy metal ions is hypothesized to reduce oxidative damage caused by the production of hydroxyl radicals. However, the possible mechanism of chelators as therapeutic agents for Non-Overload Conditions is not fully understood. Chelation has been investigated as a treatment of numerous Non-Overload Conditions including, but not limited to, cardiovascular disease, rheumatoid arthritis (RA), cancer, and diabetes. Mercury Poisoning: Chelation therapy has been proposed to treat metal toxicity from dental amalgam fillings, but it has not been shown that mercury amalgams cause harm to individuals with dental fillings, except in rare cases of allergy. CLINICAL EVIDENCE Non-Overload Conditions Well-designed, published and peer-reviewed studies do not support chelation treatment for chronic, progressive diseases such as cardiovascular disease, atherosclerosis, diabetes, cancer, Alzheimer's disease, autism spectrum disorder, or RA. There are no studies available regarding chelation therapy for the treatment of apoplectic coma, chronic fatigue syndrome, chronic renal insufficiency, defective hearing, diabetic ulcer, cholelithiasis, gout, erectile dysfunction, multiple sclerosis, osteoarthritis, osteoporosis, Parkinson's disease, Raynaud's disease, renal calculus, schizophrenia, scleroderma, snake venom poisoning, varicose veins, or vision disorders. There is insufficient evidence that chelation therapy is safe and effective to remove other undesirable metabolites or toxins, or have a positive impact on clinical outcomes for other disease states. Alzheimer's Disease (AD) Increased levels of aluminum have been discovered in several brain regions of individuals with AD. Epidemiological studies have linked the concentration of aluminum in drinking water and the increased occurrence of the disease. Scientists have postulated that chelation therapy might promote beneficial results in AD patients by inhibiting the deposition of aluminum in the brain or by preventing iron from catalyzing the formation of toxic hydroxyl radicals. Aluminum chelators may also reactivate aluminized metalloenzyme complexes in AD patients and permit redistribution of aluminum in the brain. A Cochrane systematic review was conducted by Sampson et al. to evaluate the efficacy of metal protein attenuating compounds (MPACs) for the treatment
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