Plasma Exchange
DESCRIPTION
Plasma exchange (PE) is a procedure in which plasma is separated from other components of the blood (apheresis) and discarded, then replaced with fluid such as albumin, allogenic plasma or a plasma substitute. The proposed therapeutic use of PE is to rapidly remove toxins or autoantibodies which can accumulate in the plasma as a result of disease process. Although PE can rapidly reduce levels of serum autoantibodies, a feedback mechanism may lead to a rebound overproduction of the same antibodies. PE has been used in a wide variety of acute and chronic conditions.
Note: Applications of PE can be broadly subdivided into 2 general categories: (1) acute self-limited diseases, in which PE is used to lower the circulating pathogenic substance; and (2) chronic diseases, in which there is ongoing production of pathogenic autoantibodies. Treatment goals and duration of treatment with PE need to be clearly established before its initiation. Without such treatment goals, the use of an acute short-term course of PE may insidiously evolve to a chronic use of PE with uncertain benefit. For example, a meaningful clinical response for chronic inflammatory demyelinating polyneuropathy (CIDP) would be an improvement in neurological disability scores (e.g., Hughes GBS Disability Scale, Overall Disability Sum Score). However, studies show progress made will most likely last only for the short term. Another example is the use of plasma exchange when used to treat myasthenia gravis or Guillain-Barre’. Clinical response would show measurable improvement in bedside spirometry readings. Additionally, neuromyelitis optica and neuromyelitis optica spectrum disorder (NMO/NMOSD), a rare but clinically aggressive demyelinating disease of the central nervous system, that does not respond to initial treatment of steroids may respond to a short course of plasma exchange treatments, especially if previous treatments resulted in improvements in visual acuity or disability scores.
POLICY
Plasma exchange is considered medically necessary when the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Plasma exchange for the treatment of all other diseases/conditions is considered investigational.
MEDICAL APPROPRIATENESS
Plasma exchange is considered medically appropriate for ANY ONE of the following conditions when criteria are met:
Autoimmune
Severe multiple manifestation of mixed cryoglobulinemia (e.g., cryoglobulinemic nephropathy, skin ulcers, sensory motor neuropathy and widespread vasculitis) used in conjunction with immunosuppressive treatment
Catastrophic anti-phospholipid syndrome (CAPS)
Pediatric post-infectious autoimmune neuropsychiatric disorders (e.g., PANDAS, Sydenham’s Chorea; which typically follow Group-A beta-hemolytic streptococcus infection)
Wilson’s Disease, fulminant (autosomal recessive genetic disorder resulting in copper accumulation in the liver, brain, cornea, and kidney)
Hematologic
ABO incompatible hematopoietic progenitor cell transplantation
Hyperviscosity syndrome as indicated by ANY ONE of the following:
Multiple myeloma
Waldenström's macroglobulinemia
Thrombotic thrombocytopenia purpura (TTP)
Immune (or idiopathic) thrombocytopenia purpura (ITP) that is refractory
Atypical hemolytic-uremic syndrome (HUS)
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)
Myeloma with acute renal failure
Familial hypercholesterolemia as indicated by ANY ONE of the following:
Homozygous familial hypercholesterolemia when LDL cholesterol is greater than 500 mg/dL
Heterozygous familial hypercholesterolemia when LDL cholesterol is greater than 190 mg/dL
Transplant
Solid organ transplantation with ABO incompatibility or positive crossmatch demonstrated by high panel reactive antibody (PRA) screen, when a suitable nonreactive live or cadaveric donor is unavailable in ANY ONE of the following:
Kidney
Heart (infant)
Liver transplantation (living donor) for desensitization, ABO incompatible
Acute allograft cardiac rejection/desensitization
Post renal transplant for antibody mediated rejection
Focal segmental glomerulosclerosis only when following renal transplant
Renal
Anti-glomerular basement membrane antibodies (i.e., Goodpasture's syndrome) with ANY ONE of the following:
Diffuse alveolar hemorrhage
Individual not dialysis dependent
Antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (e.g., Wegner’s granulomatosis) with associated renal failure (serum CR above 5.7 mg/dl)
Dense deposit disease or membranoproliferative glomerulonephritis with renal impairment, neuropathy, arthralgia, and/or ulcerating purpura
Neurologic
Multiple Sclerosis not responsive to high-dose steroids
Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome)
Acute neuromyelitis optica (NMO) with ANY ONE of the following:
Escalation therapy after failed high-dose intravenous corticosteroids
Initial treatment with history of failed response to steroids
Chronic neuromyelitis optica (NMO) with ALL of the following met:
Failed high-dose corticosteroids
Failed or not medically appropriate azathioprine with or without low-dose intravenous corticosteroids
Failed or not medically appropriate mycophenolate mofetil with or without low-dose intravenous corticosteroids
Failed or not medically appropriate rituximab
Myasthenia gravis with ANY ONE of the following:
Moderate to severe
Pre-thymectomy
Progressive multifocal leukoencephalopathy (all brain white matter diseases) associated with natalizumab
N-methyl D-aspartate receptor antibody encephalitis (autoimmune neurological disorder, NMDAR)
IgM, IgA or IgG chronic acquired paraproteinemia demyelinating polyneuropathy
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Based on data from published studies and/or clinical support, plasma exchange is considered medically necessary for selected conditions. For all other conditions, there is a lack of data regarding efficacy and clinical support.
SOURCES
American Society for Apheresis. (2023). Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the writing committee of the American Society for Apheresis: the eighth special issue. Journal of Clinical Apheresis, 34 (3), 171-354. Retrieved June 5, 2024 from https://www.apheresis.org/page/Guidelines.
Centers for Medicare & Medicaid Services. CMS.gov. NCD for apheresis (110.14). Retrieved January 8, 2016 from https://www.cms.gov.
Codron, P., Cousin, M., Subra, J., Pautot, V., Letournel, F., Verny, C., et al. (2017). Therapeutic plasma exchange in chronic dysimmune peripheral neuropathies: A 10-year retrospective study. Journal of Clinical Apheresis, [e-published ahead of print] Abstract retrieved July 18, 2017 from PubMed database.
Deschamps, R., Gueguen, A., Parquet, N., Saheb, S., Driss, F., Mesnil, M., et al. (2016). Plasma exchange response in 34 patients with severe optic neuritis. Journal of Neurology, 263 (5), 883-887. Abstract retrieved July 18, 2017 from PubMed database.
Mehndiratta, M., Hughes, R., & Pritchard. J. (2015). Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database of Systematic Reviews, Issue 8. Art. No.: CD003906. (Level 2 evidence)
Oaklander, A., Lunn, M., Hughes, R., van Schaik, I., Frost, C., Chalk, C., et al. (2017). Treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): an overview of systematic reviews. The Cochrane Database Systematic Reviews, 1 (1), CD010369. (Level 1 evidence)
Walsh, M., Collister, D., Zeng, L., Merkel, P., Pusey, C., Guyatt, G., et al. (2022). The effects of plasma exchange in patients with ANCA-associated vasculitis: an updated systematic review and meta-analysis. BMJ (Clinical Research Ed.), 376, e064604. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 5/1981
MOST RECENT REVIEW DATE: 7/11/2024
ID_BT
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