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Medical Policy: 08.01.15
Original Effective Date: June 2003
Reviewed: August 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Low-density lipoprotein (LDL) apheresis is a technology used to remove low-density lipoproteins from the plasma. Several LDL apheresis systems are currently available. In all methods, plasma is obtained by a primary separation system. Blood is withdrawn from the patient via peripheral venous access and circulates through the extracorporeal circuit in which hollow-fiber separators remove the plasma from the cellular blood components. The low-density lipoproteins are then selectively removed from the plasma by immunoadsorption, heparin-induced extracorporeal LDL precipitation (also known as HELP®) or Dextran sulfate adsorption. The plasma is then returned to the patient. LDL apheresis must be distinguished from plasma exchange (plasmapheresis).
Homozygous familial hypercholesterolemia is a rare disorder. Sufficiently-powered randomized controlled trials evaluating the net benefit of low density lipoprotein apheresis to these patients are unlikely to be forthcoming. Based on strong recommendations from low quality evidence, apheresis is a reasonable alternative to plasmapheresis in homozygotes who, despite maximal medical therapy, continue to maintain significantly elevated low density lipid profiles or have evidence of progressive lipid-associated complications.
Heterozygous familial hypercholesterolemia is less rare and evidence is less compelling to recommend apheresis. However, due to known variability of severity of lipid disorders with this condition, apheresis is a reasonable strategy in these patients to reduce low-density lipid levels to reduce atherosclerotic risk when, despite maximal medical therapy over six months, LDL remains above 300 mg/dL in asymptomatic individuals, or above 200 mg/dL in patients with known coronary artery disease.
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Prior Approval:
Not applicable
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Policy:
Low-density lipid apheresis may be considered medically necessary when any one of the following criteria are met:
- For patients with homozygous familial hypercholesterolemia as an alternative to plasmapheresis;
- Functional hypercholesterolemic patients with LDL ≥200 mg/dl and documented coronary artery disease (i.e. history of myocardial infarction, coronary artery bypass surgery, percutaneous transluminal angioplasty or alternative revascularization procedure, or progressive angina documented by exercise or non-exercise test; or
- For patients with familial hypercholesterolemia who fail a six month trial of therapy (i.e. trial of drugs from at least two separate classes of Hypolipidemic agents) and who meet the following FDA-approved indication;
- Functional hypercholesterolemic patients with an LDL ≥300 mg/dl.
Low-density lipid apheresis is considered investigational if at least one of the conditions listed above are not met. At this time the data are insufficient to determine the impact of LDL apheresis on conditions other than those listed above.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes
- CPT 36516 Therapeutic apheresis; with extracorporeal selective adsorption or selective filtration and plasma reinfusion
- HCPCS S2120 Low density lipoprotein (LDL) apheresis using heparin-induced extracorporeal LDL precipitation
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Selected References:
- Bambauer R. Low-density lipoprotein apheresis: Clinical results with different methods. Artificial Organs 2002;26(2):133-139.
- Bambauer R, Schneidewind J_M, Latza R. Apheresis technologies for prevention and regression of atherosclerosis: clinical results. ASAIO Journal1999;45:403-407.
- Schettler V, Wieland E, ArmstrongVW et.al. First steps towards the establishment of a German low-density lipoprotein-apheresis registry: recommendations for the indication and for quality management. Therapeutic Apheresis 2002;6(5):381-383.
- Archontakis S, Pottle A, Hakim N, Ilsley C, Barbir M. LDL-apheresis: indications and clinical experience in a tertiary cardiac center. Int J Clin Pract. 2007 Nov; 61(11):1934-42.
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Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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