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Chelation Therapy

Policy Number: MP-085

Latest Review Date: February 2024

Category: Pharmacology                                                       

POLICY:

Chelation therapy may be considered medically necessary in the treatment of each of the following conditions when performed in the in-patient setting:

  • Control of ventricular arrhythmias or heart block associated with digitalis toxicity;
  • Emergency treatment of hypercalcemia;
  • *Extreme conditions of metal toxicity (i.e. arsenic, cadmium, copper, mercury);
  • Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) and due to non-transfusion-dependent thalassemia (NDTD);
  • Wilson's disease (hepatolenticular degeneration);
  • Lead poisoning.

 

Chelation therapy for the treatment of sickle cell anemia, thalassemias, and iron overload in patients requiring frequent transfusion may be considered medically necessary when taken orally, or performed as an outpatient procedure, or given in the home health setting.

 

Chelation therapy in any form (IV, PO, transdermal, topical or rectal) is investigational when performed in an inpatient or outpatient setting to treat any other condition; including but not limited to, Alzheimer’s disease, atherosclerosis, myocardial infarction, autism, and diabetes.

 

Any treatment associated with non-covered chelation therapy (e.g. glutathione and vitamin C) is considered investigational.

 

*Chelation therapy performed to treat heavy metal and/or lead poisoning detected by a provocative urine test is considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

Chelation therapy is an established treatment for the removal of metal toxins by converting them to a chemically inert form that can be excreted in the urine. Chelation therapy consists of the intravenous or oral administration of chelating agents that remove metal ions such as lead, aluminum, mercury, arsenic, zinc, iron, copper, and calcium from the body. Specific chelating agents are used for particular heavy metal toxicities.  

There are a number of indications for chelation therapy that have received FDA approval and for which chelation therapy is considered standard of care treatment. These include:

  • Extreme conditions of metal toxicity
  • Treatment of chronic iron overload due to blood transfusions and due to non-transfusion dependent thalassemia
  • Wilson disease
  • Lead poisoning
  • Control of ventricular arrhythmias or heart block associated with digitalis toxicity; and
  • Emergency treatment of hypercalcemia

Chelation therapy has been investigated for a variety of other applications including treatment of atherosclerosis, arthritis, diabetes, multiple sclerosis, and autism.  However, there is insufficient evidence that chelation therapy improves health outcomes for any condition other than those that have received FDA approval.

Another class of chelating agents, called metal protein attenuating compounds (MPACs), is under investigation for the treatment of Alzheimer’s disease, which is associated with the disequilibrium of cerebral metals. Unlike traditional systemic chelators that bind and remove metals from tissues systemically, MPACs have subtle effects on metal homeostasis and abnormal metal interactions. In animal models of Alzheimer’s disease, they promote the solubilization and clearance of β-amyloid by binding its metal-ion complex and also inhibit redox reactions that generate neurotoxic free radicals. Therefore, MPACs interrupt two putative pathogenic processes of Alzheimer’s disease. However, no MPACs have received U.S. Food and Drug Administration (FDA) approval for the treatment of Alzheimer’s disease.

KEY POINTS:

This policy was updated with a literature search through February 14, 2024.

Summary

For individuals who have Alzheimer disease, cardiovascular disease, arthritis, autism, arthritis, diabetes, or multiple sclerosis who receive chelation therapy, the evidence includes a small number of RCTs and case series. Relevant outcomes include symptoms, change in disease status, morbid events, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One RCT, the Trial to Assess Chelation Therapy (TACT), reported that chelation therapy reduced cardiovascular events in patients with a previous myocardial infarction and that the benefit was greater in diabetic patients compared with nondiabetic patients. However, this trial had significant limitations, including high dropout rates, and therefore conclusions are not definitive. For other conditions, the available RCTs did not report improvements in health outcomes with chelation therapy and, as evidence, the case series are inadequate to determine efficacy.  The evidence is insufficient to determine the technology results in an improvement in net health outcomes.

Practice Guidelines and Position Statements

American Heart Association and American College of Cardiology

In 2016, the American College of Cardiology (ACC) and the American Heart Association (AHA) published a joint guideline on the management of patients with lower extremity peripheral artery disease, which stated that chelation therapy (e.g., ethylenediaminetetraacetic acid) is not beneficial for the treatment of claudication.

In 2014, the ACC and AHA published a focused update of the guideline for the management of stable ischemic heart disease, in conjunction with the American Association for Thoracic Surgery, Preventative Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. This update included a revised recommendation on chelation therapy stating that the “usefulness of chelation therapy is uncertain for reducing cardiovascular events in patients with stable IHD.” Compared to the original publication of this guideline in 2012, the recommendation was upgraded from a class III (no benefit) to class IIb (benefit ≥ risk), and the level of evidence from C (only consensus expert opinion, case studies, or standard of care) to B (data from a single randomized trial or nonrandomized studies). A 2023guideline from these organizations on managing chronic coronary disease provided comments about chelation therapy but no formal recommendations.

American Heart Association

In 2023, the AHA published a scientific statement about the cardiovascular risk of contaminant metals. The authors cited the TACT trial findings of a reduced relative risk of cardiovascular events among patients who received chelation therapy, but also noted that TACT did not evaluate metal levels. Results of the TACT2 trial (which finished in 2023), are awaited to provide objective data on the metal level lowering effects of chelation therapy.

American Academy of Pediatrics

In 2019, the American Academy of Pediatrics published guidance for the management of children with autism spectrum disorder.  The guidance cautioned against the use of chelation therapy due to safety concerns and lack of supporting efficacy data.

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Chelation therapy, toxic metal ions, dimercaprol, edetate calcium disodium, deferoxamine, penicillamine, Succimer, Desferal

APPROVED BY GOVERNING BODIES:

In 1953, calcium-ethylenediaminetetraacetic acid (EDTA; Versenate) was approved by the FDA for lowering blood lead levels among both pediatric and adult patients with lead poisoning. In 1991, Succimer (Chemet) was approved by the FDA for the treatment of lead poisoning in pediatric patients only. FDA approved disodium-EDTA for use in selected patients with hypercalcemia and for use in patients with heart rhythm problems due to intoxication with digitalis. In 2008, FDA withdrew approval of disodium-EDTA due to safety concerns and recommended that other forms of chelation therapy be used.

Several iron chelating agents have received FDA approval.

  • In 1968, deferoxamine (Desferal®; Novartis) was approved by the FDA for subcutaneous, intramuscular or intravenous injections was approved for treating acute iron intoxication and chronic iron overload due to transfusion-dependent anemia. Several generic forms of deferoxamine have been approved by the FDA.
  • In 2005, deferasirox (ExjadeÒ; Novartis) was approved by FDA and is available as a tablet for oral suspension and is indicated for the treatment of chronic iron overload due to blood transfusions in patients age 2 years and older. Under the accelerated approval program, FDA expanded the indications for deferasirox in 2013 to include treatment of patients age 10 years and older with chronic iron overload due to non-transfusion-dependent thalassemia syndromes and specific liver iron concentration and serum ferritin levels. A generic version of deferasirox tablet for oral suspension has also been approved by FDA. In 2015, an oral tablet formulation for deferasirox (Jadenu™) was approved by FDA. All formulations of deferasirox carry a boxed warning because it may cause serious and fatal renal toxicity and failure, hepatic toxicity and failure, and gastrointestinal hemorrhage. As a result, treatment with deferasirox requires close patient monitoring, including laboratory tests of renal and hepatic function.
  • In 2011, the FDA approved the iron chelator deferiprone (Ferriporx®) for the treatment of patients with transfusional overload due to thalassemia syndromes when other chelation therapy is inadequate. Deferiprone is available in tablet and oral solution. Ferriprox® carries a boxed warning because it can cause agranulocytosis that can lead to serious infections and death. As a result, absolute neutrophil count should be monitored before and during treatment.

In a June 2014 warning to consumers, FDA advised that FDA-approved chelating agents are available by prescription only. There are no FDA-approved over-the-counter chelation products.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

HCPCS codes:

M0300

IV chelation therapy (chemical endarterectomy)

J0470 

Injection, dimercaprol

J0600

Injection, edetate calcium disodium, up to 1,000 mg

J0895

Injection, deferoxamine mesylate, 500 mg

J3520 

Edetate disodium (EDTA, Diostate) per 150 mg

S9355

Home infusion therapy, chelation therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem.

 

REFERENCES:

  1. Adal A. Medscape. Heavy metal toxicity. 2018; http://emedicine.medscape.com/article/814960-overview. Accessed January 24, 2018.
  2. Agency for Toxic Substances and Disease Registry. Toxicological profile for mercury. 2022 March; https://www.atsdr.cdc.gov/ToxProfiles/tp46.pdf. 
  3. Anderson JL, Halperin JL, Albert NM, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. Apr 2 2013; 127(13):1425-1443.
  4. Anderson TJ, Hubacek J, Wyse DG et al. Effect of chelation therapy on endothelial function in patients with coronary artery disease: PATCH substudy. J Am Coll Cardiol 2003; 41(3):420-5.
  5. Ballas and Samir K. Iron overload is a determinant of morbidity and mortality in adult patients with sickle cell disease. Seminars in Hematology, January 2001, Vol. 38, No. 1, Suppl 1, pp. 30-36.
  6. Bartholomew John R and Gray Bruce H. General medical care of the patient with rheumatic disease: Large artery occlusive disease, Rheumatic Diseases Clinics of North America, August 1999, Vol. 25, No. 3.
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  10. Centers for Disease Control and Prevention (CDC). Childhood Lead Poisoning Prevention. December 2, 2022;http://www.cdc.gov/nceh/lead/ACCLPP/blood_lead_levels.htm. Accessed January 4, 2023.
  11. Centers for Disease Control and Prevention (CDC). Deaths associated with hypocalcemia from chelation therapy--Texas, Pennsylvania, and Oregon, 2003-2005. MMWR Morb Mortal Wkly Rep 2006; 55(8):204-7.
  12. Centers for Disease Control and Prevention (CDC). Emergency preparedness and response. Case definition: thallium. 2015November 18; https://emergency.cdc.gov/agent/thallium/casedef.asp.
  13. Centers for Disease Control and Prevention (CDC). Very high blood lead levels among adults - United States, 2002-2011. MMWR Morb Mortal Wkly Rep. Nov 29 2013; 62(47): 967-71.
  14. Chen KH, Lin JL, Lin-Tan DT et al. Effect of chelation therapy on progressive diabetic nephropathy in patients with type 2 diabetes and high-normal body lead burdens. Am J Kidney Dis 2012;60(4):530-8.
  15. Cohen Alan R and Martin Marie B. Iron chelation therapy in sickle cell disease. Seminars in Hematology, January 2001, Vol. 38, No. 1, Suppl 1, pp. 69-72.
  16. Cooper GJ, Young AA, Gamble GD et al. A copper (II)-selective chelator ameliorates left-ventricular hypertrophy in type 2 diabetic patients: a randomized placebo-controlled study. Diabetologia 2009; 52(4):715-22.
  17. Cuajungco Math P, et al. Metal chelation as a potential therapy for Alzheimer’s disease.  Annals of the New York Academy of Sciences, 2000, 920:292-304.
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  21. Ernst E. Chelation therapy for peripheral arterial disease: A systematic review. Circulation 1997, 96:1031.
  22. Escolar E, Lamas GA, Mark DB et al. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circulation. Cardiovascular quality and outcomes 2014; 7(1):15-24.
  23. Escolar E, Ujueta F, Kim H, et al. Possible differential benefits of edetate disodium in post-myocardial infarction patients withdiabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J DiabetesComplications. Aug 2020; 34(8): 107616.
  24. Fihn SD, Blankenship JC, Alexander KP, et al. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. Nov 4 2014; 64(18):1929-1949.
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  26. Food and Drug Administration. FDA warns consumers about potential health risks from using Thorne Research’s Captomer products. 2014 June 12; www.fda.gov/Drugs/DrugSafety/ucm400977.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed January 23, 2018
  27. George GN, et al. Mercury binding to the chelation therapy agents DMSA and DMPS and the rational design of custom chelators for mercury. Chemical Res Toxicology, August 2004; 17(8): 999-1006.
  28. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With LowerExtremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. Mar 21 2017; 135(12): e726-e779.
  29. Grolez G, Moreau C, Sablonniere B, et al. Ceruloplasmin activity and iron chelation treatment of patients with Parkinson's disease. BMC Neurol. 2015; 15:74.
  30. Guldager B, Jelnes R, Jorgensen SJ et al. EDTA treatment of intermittent claudication--a double-blind placebo-controlled study. J Intern Med 1992; 231(3):261-7.
  31. Hyman SL, Levy SE, Myers SM, et al. Identification, Evaluation, and Management of Children With Autism Spectrum Disorder.Pediatrics. Jan 2020; 145(1).
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  33. Kempson IM, Lombi E. Hair analysis as a biomonitor for toxicology, disease and health status. Chem Soc Rev. Jul 2011;40(7):3915-3940.
  34. Knudtson ML, Wyse DG, Galbraith PD et al. Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA 2002; 287(4):481-6.
  35. Lamas GA, Anstrom KJ, Navas-Acien A, et al. The trial to assess chelation therapy 2 (TACT2): Rationale and design. AmHeart J. Oct 2022; 252: 1-11.
  36. Lamas GA, Bhatnagar A, Jones MR, et al. Contaminant Metals as Cardiovascular Risk Factors: A Scientific StatementFrom the American Heart Association. J Am Heart Assoc. Jul 04 2023; 12(13): e029852.
  37. Lamas GA, Boineau R, Goertz C, et al. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: the factorial group results of the trial to assess chelation therapy. Am Heart J. Jul 2014; 168(1):37-44 e35.
  38. Lamas GA, Goertz C, Boineau R et al. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA 2013; 309(12):1241-50.
  39. Lannfelt L, Blennow K, Zetterbert H et al. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol 2008:7(9):779-86.
  40. Lewis EF, Ujueta F, Lamas GA, et al. Differential Outcomes With Edetate Disodium-Based Treatment Among Stable PostAnterior vs. Non-Anterior Myocardial Infarction Patients. Cardiovasc Revasc Med. Nov 2020; 21(11): 1389-1395.
  41. Mark DB, Anstrom KJ, Clapp-Channing NE, et al. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. Jul 2014; 7(4):508-516.
  42. Maron DJ, Hlatky MA. Trial to Assess Chelation Therapy (TACT) and equipoise: When evidence conflicts with beliefs. Am Heart J. Jul 2014; 168(1):4-5.
  43. Nelson KB, Bauman ML. Thimerosal and autism? Pediatrics 2003; 111(3):674-9.
  44. Ng DK, Chan CH, Soo MT et al. Low-level chronic mercury exposure in children and adolescents: meta-analysis. Pediatr Int 2007; 49(1):80-7.
  45. Nissen SE. Concerns about reliability in the Trial to Assess Chelation Therapy (TACT). JAMA 2013; 309(12):1293-4.
  46. Qaseem A, Fihn SD, Dallas P, et al. Management of Stable Ischemic Heart Disease: Summary of a Clinical Practice Guideline From the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons. Annals of Internal Medicine. 2012; 157(10):735-743.
  47. Ravalli F, Vela Parada X, Ujueta F, et al. Chelation Therapy in Patients With Cardiovascular Disease: A SystematicReview. J Am Heart Assoc. Mar 15 2022; 11(6): e024648.
  48. Risher JF, et al. Mercury exposure: evaluation and intervention the inappropriate use of chelating agents in the diagnosis and treatment of putative mercury poisoning. Neurotoxicology, August 2005; 26(4): 691-699.
  49. Ritchie CW, Bush AI, Mackinnon A et al. Metal-protein attenuation with Iodochlorhydroxyquin (clioquinol) targeting Aβ amyloid deposition and toxicity in Alzheimer disease: a pilot phase 2 clinical trial. Arch Neurol 2003; 60(12):1685-91.
  50. Rossignol DA. Novel and emerging treatments for autism spectrum disorders: A systematic review. Ann Clin Psychiatry 2009; 21(4):213-36.
  51. Sampson E, Jenagaratnam L, McShane R. Metal protein attenuating compounds for the treatment of Alzheimer’s disease. Cochrane Database Syst Rev 2008; (1):CD005380.
  52. Sampson EL, Jenagaratnam L, McShane R. Metal protein attenuating compounds for the treatment of Alzheimer's dementia. Cochrane Database Syst Rev. 2012; 5:CD005380.
  53. Sampson EL, Jenagaratnam L, McShane R. Metal protein attenuating compounds for the treatment of Alzheimer'sdementia. Cochrane Database Syst Rev. Feb 21 2014; (2): CD005380.
  54. Sazma Kathleen, et al. Practice parameter for the recognition, management, and prevention of adverse consequences of blood transfusion. Archives of Pathology and Lab Medicine, January 2000, Vol. 124, pp. 61-70.
  55. Snow V, Barry P, Fihn SD et al. Primary care management of chronic stable angina and asymptomatic suspected or known coronary artery disease: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2004; 141(7):562-7.
  56. Ujueta F, Arenas IA, Escolar E, et al. The effect of EDTA-based chelation on patients with diabetes and peripheral arterydisease in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. Jul 2019; 33(7): 490-494.
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  59. van Eijk LT, Heemskerk S, van der Pluijm RW et al. The effect of iron loading and iron chelation on the innate immune response and subclinical organ injury during human endotoxemia: a randomized trial. Haematologica 2014; 99(3):579-87.
  60. Villarruz MV, Dans A, Tan F. Chelation therapy for atherosclerotic cardiovascular disease. Cochrane Database Syst Rev 2002; (4):CD002785.
  61. Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management ofPatients With Chronic Coronary Disease: A Report of the American Heart Association/American College of CardiologyJoint Committee on Clinical Practice Guidelines. Circulation. Aug 29 2023; 148(9): e9-e119.
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POLICY HISTORY:

Medical Policy Group, December 2002

Medical Policy Administration Committee, January 2003

Available for comment February 6-March 24, 2003

Medical Policy Group, December 2005 (1)

Medical Policy Group, January 2006 (1)

Medical Policy Administration Committee, February 2006

Available for comment March 1-April 14, 2006

Medical Policy Group, April 2006 (2)

Medical Policy Administration Committee, April 2006

Available for comment April 20-June 5, 2006

Medical Policy Group June 2006 (2)

Medical Policy Administration Committee, June 2006

Available for comment July 5-August 18, 2006

Medical Policy Group, June 2009 (1)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Panel, April 2012

Medical Policy Group, April 2012 (2): Update Key Points, References, Governing Agencies information

Medical Policy Panel, June 2013

Medical Policy Group, September (2): Chronic iron overload due to non-transfusion-dependent thalassemia (NDTD) added to medically necessary statement based on new FDA approval. Secondary prevention in patients with myocardial infarction added to bullet point in investigational statement on atherosclerosis. Key Points and References updated to support policy changes.  Old references removed.

Medical Policy Administration Committee, September 2013

Available for comment September 19 through November 2, 2013

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (4): Updated Key Points, Practice and Position Statement and References.  No changes to the policy statement at this time.

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, and References.  Reworded Policy statement to clarify Chelation therapy in any form is considered investigational in the inpatient or outpatient setting for any other condition. Also reworded policy statement to clarify treatments associated with non-covered chelation therapy is considered investigational. No change to policy intent.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (4): Updates to Key Points. Clarified policy statement by adding specific metal toxicities and added commas to separate sickle cell and thalassemia; edited category from therapy to pharmacology.

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (4): Updates to Key Points, Approved by Governing Bodies, and References; From Policy section, removed “Effective for dates of service prior to November 3, 2013” and policy statements pertaining to these dates.

Medical Policy Group, October 2017 (4): Added Key Word Desferal. No other changes.

Medical Policy Panel, February 2018

Medical Policy Group, February 2018 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Group, May 2018 (4): Added HCPCS code S9355 to Current Coding.

Medical Policy Panel, February 2019

Medical Policy Group, March 2019 (4): Updates to Key Points and References. No change to policy statements.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (4): Updates to References.  No change to policy statement.

Medical Policy Panel, February 2021

Medical Policy Panel, February 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (4): Updates to Description, Approved Governing Bodies, and References.  No change to policy statements.   Removed the following referece:  2011 ACCF/AHA Focused Update of the Guideline for the Management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. Nov 1 2011; 124(18):2020-2045.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (4): Updates to Approved by Governing Bodies, Benefit Application, and References.  No change to policy statements.

Medical Policy Panel, February 2024

Medical Policy Group, February 2024 (4):  Updates to Key Points and References.  No change to policy statements.

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.