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Medical Policy: 08.01.16
Original Effective Date: February 2000
Reviewed: October 2011
Revised: October 2011
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:
The term plasmapheresis, therapeutic apheresis, and plasma exchange are often used interchangeably, however there are some differences. The following are the definitions:
Apheresis is a general term describing removal of blood from a subject; a portion of the blood is separated and retained while the rest is returned to the donor.
Plasmapheresis, which describes the process whereby the plasma is separated and manipulated in a variety of ways, is probably the most common type of apheresis process.
Plasma exchange (PE), the process in which plasma is isolated, then discarded and replaced with a substitute fluid such as albumin, is frequently done in conjunction with plasmapheresis.
The rational for PE is based on the fact that circulating substances, such as toxins or autoantibodies can accumulate in the plasma. Also, it is hypothesized that removal of these factors can be therapeutic in certain situations. It is usually a symptomatic treatment since it does not deal with the source of the pathogenic factors. Therefore the success of PE will depend on whether the pathogenic substances are accessible through the circulation and whether their rate of production and transfer to the plasma component can be adequately addressed by PE. For example, PE can rapidly reduce levels of serum autoantibodies; however, through a feedback mechanism, this rapid reduction may lead to a rebound overproduction of the same antibodies. This rebound production of antibodies is thought to render the replicating pathogenic clone of lymphocytes more vulnerable to cytotoxic drugs; therefore, PE is sometimes used in conjunction with cyclophosphamide.
Application of PE can be broadly subdivided into two general categories: 1) acute self-limited diseases, in which PE is used to acutely lower the circulating pathogenic substances; and2) chronic diseases, in which there is ongoing production of pathogenic autoantibodies. Because PE does not address underlying pathology, and, due to the phenomenon of rebound antibody production, the use in chronic diseases has been more controversial than in acute self-limited diseases.
In addition, plasmapheresis has been used in the setting of solid organ transplantation. It has been used as a technique to desensitize high-risk patients prior to transplant and also as a treatment of antibody-mediated rejection reaction (AMR) occurring after transplant. Prior to transplant, plasmapheresis has been most commonly used to desensitize patients receiving an ABO matched kidney, often in combination with a splenectomy. As a treatment of AMR, plasmapheresis is often used in combination with intravenous immunoglobulin IVIg) or anti-CD20 therapy (i.e., Rituxan).
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Prior Approval:
Not applicable
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Policy:
Plasmapheresis and plasma exchange may be considered medically necessary for any of the conditions listed below:
Autoimmune
- Severe multiple manifestations of mixed cryoglobulinemia (MC) such as cryoglobulinemic nephropathy, skin ulcers, sensory motor neuropathy, and widespread vasculitis in combination with immunosuppressive treatment
- Pemphigus
- Life-threatening rheumatoid vasculitis
- Systemic lupus erythematosus unresponsive or refractory to conventional treatment
Hematologic
- ABO incompatible hematopoietic progenitor cell transplantation
- Hyperviscosity syndrome associated with multiple myeloma or Waldenström’s macroglobulinemia
- Idiopathic thrombocytopenic purpura in emergency situations
- Thrombotic thrombocytopenic purpura (TTP)
- Atypical hemolytic-uremic syndrome
- Post-transfusion purpura
- HELLP syndrome of pregnancy (a severe form of preeclampsia, characterized by hemolysis [H], elevated liver enzymes [EL], and low platelet [LP] counts)
Neurological
- Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome [GBS]; severity grade 1-2 within 2 weeks of onset; severity grade 3-5 within 4 weeks of onset; and children younger than 10 years old with severe GBS)
- Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
- Multiple sclerosis; acute fulminant central nervous system (CNS) demyelination
- Myasthenia gravis in crisis or as part of preoperative preparation
- Paraproteinemia polyneuropathy; IgA, IgG
- Chronic inflammatory relapsing demyelinating polyneuropathy for patients with severe or life-threatening symptoms who have failed to respond to conventional therapy with prednisone or intravenous immunoglobulins (IVIg)
Renal
- Anti-glomerular basement membrane disease (Goodpasture’s syndrome)
- ANCA-associated vasculitis (e.g. Wegener’s granulomatosis) with associated renal failure (serum Cr > 5.8mg/dL)
Transplantation
- Prior to solid organ transplant, treatment of patients at high risk of antibody-mediated rejection, including highly sensitized patients, and those receiving an ABO-incompatible organ
- Following solid organ transplant, treatment of antibody-mediated rejection
Investigational applications of plasma exchange or plasmapheresis include, but are not limited to the following conditions:
- Rheumatoid arthritis
- Scleroderma (systemic sclerosis)
- Polymyositis and dermatomyositis
- Inclusion body myositis
- Chronic progressive or relapsing remitting multiple sclerosis
- Amyotrophic lateral sclerosis (ALS)
- Paraneoplastic syndromes including Lambert-Eaton myasthenic syndrome
- Paraproteinemic polyneuropathy including monoclonal gammopathy of undetermined significance (MGUS)
- Chronic fatigue syndrome
- Regional enteritis (Crohn's disease)
- Rapidly progressive glomerulonephritides, excluding those related to anti-basement membrane immunoglobulins ( i.e. Goodpasture's syndrome)
- Asthma
-
Stiff-man syndrome
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Procedure Codes and Billing Guidelines:
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Selected References:
- Brian G, et al. A Randomized Trial of Plasma Exchange in Acute Central Nervous System Inflammatory Demyelinating Disease. The American Neurological Association Annals of Neurology 1999; 46(6):878-86.
- Shumak KH, Rock GA. Therapeutic plasma exchange. N Engl J Med 1984; 310(12):762-71.
- Lewis EJ, Hunsicker LG, Lan SP et al. A controlled trial of plasmapheresis therapy in severe lupus nephritis. The Lupus Nephritis Collaborative Study Group. N Engl J Med 1992; 326(21):1373-9.
- Canadian Cooperative Multiple Sclerosis Study Group. The Canadian cooperative trial of cyclophosphamide and plasma exchange in progressive multiple sclerosis. Lancet 1991; 337(8739):441-6.
- Brashear HR, Phillips LH. Autoantibodies to GABAergic neurons and response to plasmapheresis in stiff-man syndrome. Neurology 1991; 41(10):1588-92.
- Sanders DB, Massey JM, Sanders LL et al. A randomized trial of 3,4-diaminopyridine in Lambert-Eaton myasthenic syndrome. Neurology 2000; 54(3):603-7.
- Weinstein R. Therapeutic apheresis in neurological disorders. J Clin Apheresis 2000; 15(1-2):74-128.
- Weinshenker BG, O’Brien PC, Petterson TM et al. A randomized trail of plasma exchange in acute central nervous system inflammatory demyelinating disease. Ann Neurol 1999; 46(6):878-86.
- Dyck PJ, Low PA, Windebank AJ et al. Plasma exchange in polyneuropathy associated with monoclonal gammopathy of undetermined significance. N Engl J Med 1991; 325(21):1482-6.
- Kyriakidis AV, Karydakis P, Neofytou N et al. Plasmapheresis in the management of acute severe hyperlipidemic pancreatitis: report of 5 cases. Pancreatology. 2005;5(2-3):201-4. Epub 2005 Apr 22.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; 2003 June; ABO-incompatible living-donor kidney transplantation for endstage kidney disease. Available: http://www.ecri.org.
- Jordan SC, Vo AA, et al. Use of high-dose human intravenous immunoglobulin therapy in sensitized patients awaiting transplantation: the Cedars-Sinai experience. Clin Transpl 2003:193-8.
- Ibernon M, Gil-Vernet S, et al. Therapy with plasmapheresis and intravenous immunoglobulin for acute humoral rejection in kidney transplantation. Transplant Proc 2005; 37(9):3743-5.
- Rockx MA, Clark WF. Plasma exchange for treating cryoglobulinemia: a descriptive analysis. Transfus Apher Sci 2010; 42(3):247-51.
- Michael M, Elliott EJ, Craig CJ et al. Interventions for hemolytic uremic syndrome and thrombotic thrombocytopenic purpura: a systematic review of randomized trials. Am J Kidney Dis 2009; 53(2):259-72.
- Noris M, Remuzzi G. Atypical hemolytic-uremic syndrome. N Engl J Med 2009; 361(17):1676-87.
- Liu J, Wang W, Zhao C et al. Comparing the autoantibody levels and clinical efficacy of double filtration plasmapheresis, immunoadsorption and intravenous immunoglobulin for the treatment of late-onset myasthenia gravis. Ther Apher Dial 2010; 14(2):153-60.
- Yuan X, Wang C, Gao W et al. Kidney transplant in highly sensitized patients after desensitization with plasmapheresis and low-dose intravenous immunoglobulin. Exp Clin Transplant 2010; 8(2): 130-5.
- Cortese I, Chaudhry V, So YT et al. Evidence-based guideline update: Plasmapheresis in neurologic disorders. Neurology 2011; 76(3):294-300.
- Martin LK, Werth VP, Villaneuva EV et al. A systematic review of randomized controlled trials for pemphigus vulgaris and pemphigus foliaceus. J Am Acad Dermatol. 2011 May; 64(5):903-8. Epub 2011 Feb 25.
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Policy History:
Date Reason Action
September 2010 Annual review Policy renewed
October 2011 Annual review Policy revised
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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
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and, therefore, cannot guarantee any results or outcomes.
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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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