Category Filter
- Advanced Imaging
- Behavioral Health
- Chronic Condition Management
- Genetic Testing
- Hemophilia Drugs
- Medical Oncology Regimen Program
- Medical Policies
- Pre-Service Review (Precertification/Predetermination)
- Provider-Administered Drug Policies
- Radiation Therapy
- Self-Administered Drug Policies
- Transgender Services
Asset Publisher
Plasma Exchange (Plasmapheresis)
Policy Number: MP-100
Latest Review Date: July 2024
Category: Therapy
POLICY:
Plasma exchange (plasmapheresis) may be considered medically necessary for ANY of the following conditions:
Autoimmune
- Severe multiple manifestation of mixed cryoglobulinemia (MC) such as cryoglobulinemic nephropathy, skin ulcers, sensory motor neuropathy, and widespread vasculitis in combination with immunosuppressive treatment;
- Catastrophic antiphospholipid syndrome
Hematologic
- ABO incompatible hematopoietic progenitor cell transplantation;
- Hyperviscosity syndromes 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);
- Myeloma with acute renal failure
Neurological
- Acute inflammatory demyelinating polyneuropathy (Guillain-Barre’ syndrome [GBS]; severity grade 1-2 within two weeks of onset; and children less than 10 years old with severe GBS);
- Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP);
- Multiple sclerosis with acute fulminant CNS demyelination;
- Myasthenia gravis in crisis or as part of preoperative preparation;
- Paraproteinemia polyneuropathy; IgA, IgG;
- Neuromyelitis optica
- N-methyl-d-aspartate receptor antibody encephalitis;
- Progressive multifocal leukoencephalopathy associated with natalizumab;
Renal
- Anti-glomerular basement membrane disease (Goodpasture’s syndrome);
- ANCA-associated vasculitis [e.g., Wegener’s granulomatosis, also known as granulomatosis with polyangiitis (GPA)] with associated renal failure;
- Dense deposit disease with factor H deficiency and/or elevated C3 Nephritic factor
Transplantation
- ABO incompatible solid organ transplantation:
- Kidney;
- heart (infants);
- Renal transplantation: antibody mediated rejection; HLA [human leukocyte antigen] desensitization;
- Focal segmental glomerulosclerosis after renal transplant
Plasma exchange (plasmapheresis) is considered investigational in all other conditions, including, but not limited, to the following:
- ABO incompatible solid organ transplant; liver
- Acute disseminated encephalomyelitis
- Acute inflammatory demyelinating polyneuropathy (Guillain-Barre syndrome) in children less than 10 years old with mild or moderate forms
- Acute liver failure
- Amyotrophic lateral sclerosis (ALS)
- ANCA-associated vasculitis [e.g., Wegener’s granulomatosis, also known as granulomatosis with polyangiitis (GPA)] without associated renal failure
- Aplastic anemia
- Asthma
- Autoimmune hemolytic anemia; warm autoimmune hemolytic anemia; cold agglutinin disease
- Chronic fatigue syndrome
- Coagulation factor inhibitors
- Cryoglobulinemia; except for severe mixed cryoglobulinemia; as noted above
- Dermatomyositis and polymyositis
- Focal segmental glomerulosclerosis (other than after renal transplant)
- Heart transplant rejection treatment
- Hemolytic uremic syndrome (HUS); typical (diarrheal-related)
- Hyperviscosity syndromes with renal failure (other than associated with multiple myeloma or Waldenström’s macroglobulinemia).
- Idiopathic thrombocytopenic purpura; refractory or non-refractory
- Inclusion body myositis
- Lambert-Eaton myasthenic syndrome
- Macular Degeneration (Age Related)
- Multiple sclerosis with chronic progressive or relapsing remitting course
- Mushroom poisoning
- Myasthenia gravis with anti-MuSK antibodies
- Obsessive compulsive disorder
- Overdose and poisoning (other than mushroom poisoning)
- Paraneoplastic syndromes
- Paraproteinemia polyneuropathy; IgM
- Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)
- Pemphigus vulgaris
- Phytanic acid storage disease (Refsum’s disease)
- POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, skin changes)
- Psoriasis
- Red cell alloimmunization in pregnancy
- Regional enteritis (Crohn’s disease)
- Rheumatoid arthritis
- Scleroderma (systemic sclerosis)
- Sepsis
- Stiff-man syndrome
- Sydenham’s chorea
- Systemic lupus erythematosus (including SLE nephritis)
- Thyrotoxicosis
Individual case consideration for coverage of plasma exchange (plasmapheresis) will be given for patients with acute, life-threatening complications of chronic autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus. However, in these situations, treatment goal and duration of treatment with PE need to be clearly established prior to its initiation to ensure that short-term treatment of the acute complication does not evolve to a chronic use of PE with uncertain benefit.
For information regarding lipid apheresis, please refer to medical policy # 103 Lipid Apheresis
For information regarding ECP, please refer to medical policy # 028 Extracorporeal Photopheresis
DESCRIPTION OF PROCEDURE OR SERVICE:
Plasma exchange (PE) is a procedure in which the plasma is isolated, then discarded and replaced with a substitution fluid such as albumin. Plasma exchange is a nonspecific therapy, because the entire plasma is discarded. PE has been used in a wide variety of acute and chronic conditions, as well as in the setting of solid organ transplantation.
The terms therapeutic apheresis, plasmapheresis, and plasma exchange (PE) are often used interchangeably, but when properly used denote different procedures. The American Society for Apheresis (ASFA) definitions for these procedures are as follows:
- Apheresis: A procedure in which blood of the patient or donor is passed through a medical device, which separates out one or more components of blood and returns remainder with or without extracorporeal treatment or replacement of the separated component.
- Plasmapheresis: A procedure in which blood of a patient or the donor is passed through a medical device which separates out plasma from the other components of blood and the plasma is removed (i.e., less than 15% of total plasma volume) without the use of replacement solution.
- Plasma exchange: A therapeutic procedure in which blood of the patient is passed through a medical device, which separates out plasma from other components of blood, the plasma, is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/ or plasma) or a combination of crystalloid/colloid solution.
This policy addresses only plasma exchange as a therapeutic apheresis procedure.
The rationale for PE is because circulating substances, such as toxins or autoantibodies, can accumulate in the plasma. In addition, it is hypothesized that removal of these factors can be therapeutic in certain situations. PE is essentially a symptomatic therapy, since it does not remove 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 PE can adequately address their rate of production and transfer to the plasma component. 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.
Applications 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 substance; and 2) 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, its 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 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 mismatched 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., rituximab).
KEY POINTS:
This policy has been updated regularly with searches of the PubMed database. The most recent literature update was performed through July 7, 2024.
Summary of Evidence
In conclusion, due to data from published studies and/or clinical support, plasma exchange meets medical criteria for coverage for selected conditions. For conditions other than those selected, plasma exchange is considered investigational.
Practice Guidelines and Position Statements
National Comprehensive Cancer Network
In the current National Comprehensive Cancer Network guidelines on multiple myeloma (v.4.2024), use of plasmapheresis to improve renal function is a category 2B recommendation. Plasmapheresis should also be used as adjunctive therapy for symptomatic hyperviscosity.
American Academy of Neurology
In 2011, the American Academy of Neurology issued evidence-based guidelines on plasmapheresis for the treatment of neurologic disorders. The primary conclusions, based on the evidence review, are provided in Table 1.
Table 1. Guidelines on Use Plasmapheresis to Treat Neurologic Disorders
Recommendation |
Conclusion |
Acute inflammatory demyelinating polyradiculoneuropathy(Guillain-Barré syndrome) |
Established effective |
Chronic inflammatory demyelinating polyneuropathy(CIDP), short-term treatment |
Established effective |
Relapses in multiple sclerosis |
Probably effective |
Fulminant demyelinating central nervous system disease |
Possibly effective |
Chronic or secondary progressive multiple sclerosis |
Established ineffective |
Myasthenia gravis |
Insufficient evidence |
Sydenham chorea |
Insufficient evidence |
Acute obsessive-compulsive disorder and tics in PANDAS |
Insufficient evidence |
PANDAS: pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections.
In 2003, the American Academy of Neurology published a practice parameter on Guillain-Barré syndrome (GBS). The following are the key findings: (1) treatment with plasma exchange (PE) or intravenous immunoglobulin hastens recovery from GBS; (2) combining the 2 treatments is not beneficial; and (3) steroid treatment given alone is not beneficial. The American Academy of Neurology’s recommendations are:
- PE is recommended for adults with GBS who are nonambulant and who seek treatment within 4 weeks of the onset of neuropathic symptoms;
- PE should be considered for ambulant patients examined within 2 weeks of the onset of neuropathic symptoms);
- PE is a treatment option for children with severe GBS.
American Society for Apheresis
In 2023, the American Society for Apheresis updated its guidelines on the use of therapeutic apheresis (Ninth Special Issue). The following is a description of the Society categories (see Table 2).
Table 2. American Society for Apheresis Categories
Category |
Description |
I |
Disorders for which apheresis is accepted as first-line treatment, either as a primary standalone treatment or in conjunction with other modes of treatment. |
II |
Disorders for which apheresis is accepted as second-line treatment, either as a standalone treatment or in conjunction with other modes of treatment. |
III |
Optimum role of apheresis therapy is not established. Decision making should be individualized. |
IV |
Disorders in which published evidence demonstrates or suggests apheresis to be ineffective or harmful. IRB approval is desirable if apheresis treatment is undertaken in these circumstances. |
IRB = Institutional Review Board
Table 3. American Society for Apheresis 2023 Key Recommendations
Indication |
Modality |
Category |
Acute disseminated encephalomyelitis (ADEM): Steroid refractory |
TPE |
II |
Acute fatty liver of pregnancy |
TPE |
III |
Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome): Primary treatment |
TPE |
I |
Acute liver failure |
TPE |
III |
Age-related macular degeneration, dry, high-risk |
DFPP |
III |
Alzheimer disease, mild or moderate |
TPE |
III |
Amyloidosis, systemic, dialysis-related |
Beta2 microglobulin adsorption |
II |
Anti-glomerular basement membrane disease (Goodpasture syndrome) |
|
|
|
TPE |
I |
|
TPE |
I |
|
TPE |
III |
Atopic dermatitis (atopic eczema), recalcitrant |
ECP/IA/TPE/DFPP |
III |
Autoimmune dysautonomia |
TPE |
III |
Autoimmune hemolytic anemia (AIHA), severe |
|
|
|
TPE |
II |
|
TPE |
III |
Babesiosis, severe |
RBC exchange |
III |
Burn shock resuscitation |
TPE |
III |
Cardiac neonatal lupus |
TPE |
III |
Catastrophic antiphospholipid syndrome (CAPS) |
TPE |
I |
Chronic acquired demyelinating polyneuropathies |
|
|
|
TPE |
I |
|
TPE |
III |
|
TPE |
III |
Chronic focal encephalitis (Rasmussen encephalitis) |
TPE/IA |
III |
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) |
TPE/IA |
I |
Coagulation factor deficiency and inhibitors |
IA |
III |
|
TPE |
III |
Complex regional pain syndrome, chronic |
TPE |
III |
Cryoglobulinemia, severe/symptomatic |
TPE/DFPP |
II |
Cutaneous T cell lymphoma (CTCL) |
|
|
|
ECP |
I |
|
ECP |
III |
Dilated cardiomyopathy, idiopathic, NYHA II-IV |
IA |
II |
Erythrocytosis |
|
|
|
Erythrocytapheresis |
I |
|
Erythrocytapheresis |
III |
Erythropoietic protoporphyria, liver disease |
TPE/RBC exchange |
II |
Familial hypercholesterolemia |
|
|
|
LA |
I |
|
LA |
II |
|
TPE |
II |
Focal segmental glomerulosclerosis (FSGS) |
|
|
|
TPE/IA |
I |
|
LA |
II |
|
TPE |
III |
Graft-versus-host disease (GVHD) |
|
|
|
ECP |
II |
|
ECP |
II |
Hemophagocytic lymphocytosis (HLH) |
TPE |
III |
Heparin-induced thrombocytopenia and thrombosis |
|
|
|
TPE/IA |
III |
|
TPE |
III |
Hereditary hemochromatosis |
Erythrocytapheresis |
I |
Hyperleukocytosis |
Leukocytapheresis |
III |
Hypertriglyceridemic pancreatitis |
|
|
|
TPE/LA |
III |
|
TPE/LA |
III |
Hyperviscosity in hypergammaglobulinemia |
|
|
|
TPE |
I |
|
TPE |
I |
Idiopathic inflammatory myopathies |
|
|
|
TPE |
III |
|
TPE |
III |
|
TPE |
III |
IgA nephropathy (Berger's disease) |
|
|
|
TPE |
III |
|
TPE |
III |
Immune checkpoint inhibitors, immune-related adverse events |
TPE |
III |
Immune thrombocytopenia (ITP), refractory |
TPE/IA |
III |
Inflammatory bowel disease |
|
|
|
Adsorptive cytapheresis |
II |
|
Adsorptive cytapheresis/ECP |
III |
Lambert-Eaton myasthenic syndrome |
TPE |
II |
Lipoprotein(a) hyperlipoproteinemia, progressive atherosclerotic cardiovascular disease |
LA |
II |
Malaria, severe* |
RBC exchange |
III |
Multiple sclerosis |
|
|
|
TPE/IA |
II |
|
TPE/IA |
III |
Myasthenia gravis |
|
|
|
TPE/DFPP/IA |
I |
|
TPE/DFPP/IA |
II |
Myeloma cast nephropathy |
TPE |
II |
Nephrogenic systemic fibrosis |
ECP/TPE |
III |
Neuromyelitis optical spectrum disorders (NMOSD) |
|
|
|
TPE/IA |
II |
|
TPE |
III |
N-methyl-D-aspartate receptor antibody encephalitis |
TPE/IA |
I |
Overdose, envenomation, and/or poisoning |
|
|
|
TPE |
II |
|
TPE |
III |
|
TPE/RBC exchange |
III |
Paraneoplastic autoimmune retinopathies |
TPE |
III |
Paraneoplastic neurologic syndromes |
TPE/IA |
III |
Pediatric autoimmune neuropsychiatric disorders |
|
|
|
TPE |
II |
|
TPE |
III |
Pemphigus vulgaris, severe |
TPE |
III |
Peripheral vascular diseases |
LA |
II |
Phytanic acid storage disease (Refsum disease) |
TPE/LA |
II |
Post-transfusion purpura (PTP) |
TPE |
III |
Progressive multifocal leukoencephalopathy (PML) associated with natalizumab |
TPE |
III |
Pruritus due to hepatobiliary disease, treatment resistant |
TPE |
III |
Psoriasis, disseminated pustular |
ECP |
III |
Red blood cell alloimmunization, pregnancy complications |
|
|
|
TPE |
III |
|
RBC exchange |
IV |
Sepsis with multiorgan failure |
TPE |
III |
Sickle cell disease |
|
|
|
RBC exchange |
I |
|
RBC exchange |
II |
|
RBC exchange/TPE |
III |
|
RBC exchange |
I |
|
RBC exchange |
II |
|
RBC exchange |
II |
|
RBC exchange |
III |
Steroid-responsive encephalopathy associated with autoimmune thyroiditis (Hashimoto encephalopathy) |
TPE |
II |
Stiff-person syndrome |
TPE |
III |
Sudden sensorineural hearing loss |
LA/DFPP/TPE |
III |
Systemic lupus erythematosus (SLE): Severe complications |
TPE |
II |
Systemic sclerosis |
ECP |
III |
Thrombocytosis |
|
|
|
Thrombocytapheresis |
II |
|
Thrombocytapheresis |
III |
Thrombotic microangiopathy |
|
|
|
TPE |
III |
|
TPE |
I |
|
TPE |
III |
|
TPE |
I |
|
TPE |
III |
|
TPE |
IV |
|
TPE |
IV |
|
TPE/IA |
III |
|
TPE |
III |
|
TPE |
III |
|
TPE/LA |
III |
|
TPE |
I |
|
TPE |
III |
Thyroid storm |
TPE |
II |
Toxic epidermal necrolysis (TEN), refractory |
TPE |
III |
Transplantation, heart |
|
|
|
ECP |
II |
|
ECP/TPE |
II |
|
TPE |
II |
|
TPE |
III |
Transplantation, hematopoietic stem cell, ABO incompatible |
|
|
|
TPE |
II |
|
TPE |
II |
|
RBC exchange |
III |
|
TPE |
III |
Transplantation, hematopoietic stem cell, HLA desensitization |
TPE |
III |
Transplantation, intestine |
|
|
|
TPE |
III |
|
TPE |
III |
Transplantation, kidney, ABO compatible |
|
|
|
TPE/IA |
I |
|
TPE/IA |
I |
Transplantation, liver |
|
|
|
TPE |
I |
|
TPE |
III |
|
ECP/TPE |
III |
|
ECP |
III |
|
ECP |
III |
Transplantation, lung |
|
|
|
ECP |
II |
|
ECP |
II |
|
TPE |
III |
|
TPE |
III |
Vaccine-induced thrombotic thrombocytopenia, refractory |
TPE |
III |
Vasculitis, ANCA-associated |
|
|
|
TPE |
III |
|
TPE |
III |
|
TPE |
III |
Vasculitis, IgA (Henoch-Schönlein purpura) |
|
|
|
TPE |
III |
|
TPE |
III |
Vasculitis, other |
|
|
|
TPE |
II |
|
TPE |
III |
|
TPE |
III |
Voltage-gated potassium channel (VGKC) antibody-related disease |
TPE/IA |
II |
Wilson disease, fulminant |
TPE |
I |
TPE: therapeutic plasma exchange; IA: immunoadsorption; TPE-HV: high-volume therapeutic plasma exchange; ECP: extracorporeal photopheresis; DFPP: double filtration plasmapheresis; NYHA: New York Heart Association; RBC: red blood cell; LA: lipoprotein apheresis; Ig: immunoglobulin; HLA: human leukocyte antigen.
U.S. Preventative Services Task Force Recommendations
Not applicable
KEY WORDS:
Plasma exchange, plasmapheresis, apheresis, therapeutic apheresis, therapeutic plasma exchange, Rheo, Rheopheresis, focal glomerulosclerosis, FGS, focal segmental glomerulosclerosis, FSGS, Neuromyelitis optica, NMO, Devic syndrome
APPROVED BY GOVERNING BODIES:
The U.S. Food and Drug Administration has a compliance program to ensure that source plasma, source leukocytes, and therapeutic exchange plasma for further manufacture into products for human use are safe, pure, potent, and appropriately labeled. The compliance program covers products intended for use in both injectable drug products (e.g., immune globulin, albumin) and noninjectable products (e.g., in vitro devices such as blood bank reagents). Product Code for Therapeutic Exchange Plasma (TEP): 57DI-65.
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.
CODING:
CPT code:
36514 |
Therapeutic apheresis; for plasma pheresis |
REFERENCES:
- Abboud H, Petrak A, Mealy M, et al. Treatment of acute relapses in neuromyelitis optica: Steroids alone versus steroids plus plasma exchange. Mult Scler. Feb 2016; 22(2):185-192.
- Alipour-Faz A, Shojaei M, Peyvandi H. A comparison between IVIG and plasma exchange as preparations before thymectomy in myasthenia gravis patients. Mar 2017; 117(1):245-249.
- Anderson KC, Alsina M, Bensinger W, et al; NCCN (National Comprehensive Cancer Network). Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma, version 2.2013. J Natl Compr Canc Netw. 2012 Oct 1;10(10):1211-9.
- Ansell SM, Kyle RA, Reeder CB, et al. Diagnosis and management of Waldenström macroglobulinemia: Mayo stratification of macroglobulinemia and risk-adapted therapy (mSMART) guidelines. Mayo Clin Proc. 2010 Sep;85(9):824-833.
- Balogun RA, Sanchez AP, Klingel R, et al. Update to the ASFA guidelines on the use of therapeutic apheresis in ANCA-associated vasculitis. J Clin Apher. 2020 Sep; 35(5): 493–499.
- Barth D, Nabavi Nouri M, Ng E et al. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology 2011; 76(23):2017-2023.
- Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. Feb 27 2017; 2:Cd001798.
- Connelly-Smith L, Dunbar NM. The 2019 guidelines from the American Society for Apheresis: what's new? Curr Opin Hematol. 2019 Nov;26(6):461-465.
- Cortese I, Chaudhry V, So YT et al. Evidence-based guideline update: Plasmapheresis in neurologic disorders. Neurology 2011; 76(3):294-300.
- DeSena AD, Noland DK, Matevosyan K, et al. Intravenous methylprednisolone versus therapeutic plasma exchange for treatment of anti-N-methyl-D-aspartate receptor antibody encephalitis: A retrospective review. J Clin Apher. Aug 2015; 30(4):212-216.
- Dwosh IL, Giles AR, Ford PM et al. Plasmapheresis therapy in rheumatoid arthritis. A controlled, double-blind trial. N Engl J Med 1983; 308(19): 1124-1129.
- Ebadi H, Barth D, Bril V. Safety of plasma exchange therapy in patients with myasthenia gravis. Muscle Nerve 2013; 47(4):510-514.
- El-Bayoumi MA, El-Refaey AM, Abdelkader AM et al. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barre Syndrome: a randomized study. Crit Care 2011; 15(4):R164.
- Food and Drug Administration (FDA). Compliance Program Guidance Manual; Chapter 42- Blood and Blood Components; www.fda.gov/media/80179/download
- Garvey MA, Snider LA, et al. Treatment of Sydenham’s chorea with intravenous immunoglobulin, plasma exchange, or prednisone. Journal of Child Neurology 2005; 20(5):424-429.
- Goodin DS, Frohman EM, Garmany GP et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002 Jan 22; 58 (2): 169-178.
- Gubensek J, Buturovic-Ponikvar J, Kandus A et al. Plasma exchange and intravenous immunoglobulin in the treatment of antibody-mediated rejection after kidney transplantation: a single-center historic cohort study. Transplant Proc 2013; 45(4):1524-1527.
- Hildebrand AM, Huang SH, Clark WF. Plasma exchange for kidney disease: What is the best evidence? Adv Chronic Kidney Dis. 2014 Mar;21(2):217-227.
- Hughes RA, Wijdicks EF, Barohn R, et al. Practice parameter: Immunotherapy for Guillain-Barre syndrome: Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, September 2003; 61(6): 736-740.
- Hughes RAC, Swan AV, et al. Immunotherapy for Guillain-Barre syndrome: A systematic review. Brain 2007; 130: 2245-2257.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Ipe TS, Pham HP, Williams LA, 3rd. Critical updates in the 7th edition of the American Society for Apheresis guidelines. J Clin Apher. Jun 27 2017.
- Kleiter I, Gahlen A, Borisow N, et al. Neuromyelitis optica: Evaluation of 871 attacks and 1,153 treatment courses. Ann Neurol. Feb 2016; 79(2):206-216.
- Kohler W, Bucka C, Klingel R et al. A randomized and controlled study comparing immunoadsorption and plasma exchange in myasthenic crisis. J Clin Apher 2011; 26(6):347-355.
- Kronbichler A, Brezina B, Quintana LF, et al. Efficacy of plasma exchange and immunoadsorption in systemic lupus erythematosus and antiphospholipid syndrome: A systematic review. Autoimmun Rev. Jan 2016; 15(1):38-49.
- Kuwabara S, Dispenzieri A, Arimura K, Misawa S, Nakaseko C. Treatment for POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome. Cochrane Database of Systematic Reviews 2012 Jun 13;2012(6).
- Larsen FS, Schmidt LE, Bernsmeier C, et al. High-volume plasma exchange in patients with acute liver failure: An open randomised controlled trial. J Hepatol. Jan 2016; 64(1):69-78.
- Lehmann HC, Hoffmann FR, Fusshoeller A, et al. The clinical value of therapeutic plasma exchange in multifocal motor neuropathy. J Neurol Sci. 2008 Aug 15;271(1-2):34-39.
- 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): 1373-1379.
- 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):153-160.
- Madore F. Plasmapheresis: Technical aspects and indications. Crit Care Clin 2002; 18 (2):375-92.
- Martin LK, Werth VP, Villaneuva EV, Murrell DF. A systematic review of randomized controlled trials for pemphigus vulgaris and pemphigus foliaceus. J Am Acad Dermatol. 2011 May;64(5):903-8.
- Matolon A, Markowitz GS, et al. Plasmapheresis treatment of recurrent FSGS in adult renal transplant recipients. Clin Nephrol 2001 Oct; 56(4):271-278.
- Mehndiratta MM, Hughes RA, Pritchard J. Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. Aug 25 2015; 8(8):CD003906.
- Merle H, Olindo S, Jeannin S, et al. Treatment of optic neuritis by plasma exchange (add-on) in neuromyelitis optica. Arch Ophthalmol. Jul 2012; 130(7):858-862.
- Michael M, Elliott EJ, et al. Interventions for hemolytic uremic syndrome and thrombotic thrombocytopenic purpura: A systematic review of randomized controlled trials. Am J Kidney Disease, February 2009; 53(2): 259-272.
- Miller FW, Leitman SF, Cronin ME et al. Controlled trial of plasma exchange and leukapheresis in polymyositis and dermatomyositis. N Engl J Med 1992; 326(21): 1380-1384.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 3.2023. www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf.
- National Institute for Neurological Disorders and Stroke (NINDS). NINDS Neuromyelitis Optica Information Page. www.ninds.nih.gov/health-information/disorders/neuromyelitis-optica.
- Nicolson R. An open trial of plasma exchange in childhood-onset obsessive-compulsive disorder without poststreptococcal exacerbations. J Am Acad Child Adolesc Psychiatry 2000; 39 (10): 1313-1315.
- Noris M and Remuzzi G. Atypical hemolytic-uremic syndrome. NEJM, October 2009; 361(17): 1676-1687.
- Okamoto T, Ogawa, M, Lin Y, et al. Treatment of neuromyelitis optica: Current debate. Therapeutic Advances in Neurological Disorders 2008; 1(43):43-52.
- Owen RG, Pratt G, Auer RL, et al; British Committee for Standards in Haematology. Guidelines on the diagnosis and management of Waldenström macroglobulinaemia. Br J Haematol. 2014 May;165(3):316-333.
- Padmanabhan A, Connelly-Smith L, Aqui N, et al. 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. J Clin Apher. Jun 2019; 34(3):171–354.
- Pagano MB, Murinson BB, Tobian AA, et al. Efficacy of therapeutic plasma exchange for treatment of stiff-person syndrome. Transfusion. Jul 2014; 54(7):1851-1856.
- Perlmutter SJ, Leitman SF, Garvey MA, et al. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet, October 1999; 354(9185): 1137-1138.
- Pham HP, Williams LA, 3rd. Therapeutic plasma exchange in two patients with stiff-person syndrome. J Clin Apher. Oct 2016; 31(5):493-494.
- Raphael JC, Chevret S, Hughes RA and Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev 2012; 7: CD001798.
- Ridel C, Kissling S, Mesnard L, et al. Plasma exchange in nephrology: Indications and technique. Nephrol Ther. 2017 Feb;13(1):43-55.
- Rimmer E, Houston BL, Kumar A, et al. The efficacy and safety of plasma exchange in patients with sepsis and septic shock: a systematic review and meta-analysis. Crit Care. Dec 20 2014; 18(6):699.
- Rockx MA, Clark WF. Plasma exchange for treating cryoglobulinemia: a descriptive analysis. Transfers Apher Sci Jun 2010; 42(3):247-251.
- Schwartz J, Padmanabhan A, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue. J Clin Apher. Jun 2016; 31(3):149-162.
- Schwartz J, Winters JL, Padmanabhan A et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: the sixth special issue. J Clin Apher Jul 2013; 28(3):145-284.
- Shaz BH, Linenberger ML, Bandarenko N, et al. Category IV indications for therapeutic apheresis: ASFA fourth special issue. J Clin Apher, June 2007; 22(3): 176-180.
- Singer HS. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. J Pediatr 200; 136 (5): 702-703.
- Smith JW and Weinstein R. Therapeutic apheresis: A summary of current indication categories endorsed by the AABB and the American Society for Apheresis. Transfusion, May 2004; 44(5): 795.
- Szczepiorkowski ZM, Winters JL, Bandarenko N et al. Guidelines on the use of therapeutic apheresis in clinical practice--evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher 2010; 25(3):83-177.
- Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment of plasmapheresis. Neurology 1996; 47 (3): 840-843.
- Van den Bergh PY, Hadden RD, Bouche P,et al; European Federation of Neurological Societies; Peripheral Nerve Society. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision. Eur J Neurol. 2010 Mar;17(3):356-63.
- Walsh M, Casian A, Flossmann O et al. Long-term follow-up of patients with severe ANCA-associated vasculitis comparing plasma exchange to intravenous methylprednisolone treatment is unclear. Kidney Int 2013; 84(2):397-402.
- Walsh M, Catapano F, Szpirt W et al. Plasma exchange for renal vasculitis and idiopathic rapidly progressive glomerulonephritis: a meta-analysis. Am J Kidney Dis 2011; 57(4):566-574.
- Weinshenker BG, O'Brien PC, Petterson TM et al. A randomized trial of plasma exchange in acute central nervous system inflammatory demyelinating disease. Ann Neurol 1999; 46(6):878-886.
- Weiss PF, Klink AJ, Friedman DF, Feudtner C. Pediatric therapeutic plasma exchange indications and patterns of use in US children's hospitals. J Clin Apher. 2012;27(6):287-94.
- White, NB. Successful rescue therapy with plasmapheresis and intravenous immunoglobulin for acute humoral renal transplant rejection. Transplantation 2004; 78(5); 772-774.
- Wingerchuk DM, Lennon VA, Lucchinetti CF, et al. The spectrum of neuromyelitis optica. Lancet Neurol 2007; 6:805-815.
- Winters JL, Gloor JM, Pineda AA, et al. Plasma exchange conditioning for ABO-incompatible renal transplantation. J Clin Apher 2004; 19(2): 79-85.
- 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):130-135.
POLICY HISTORY:
TEC Assessment, November 1998
Medical Policy Group, March 2003 (2)
Medical Policy Administration Committee, March 2003
Available for comment April 1-May 16, 2003
Medical Policy Group, March 2005 (1)
Medical Policy Administration Committee, July 2005 (2)
Available for comment July 28-September 10, 2005
Medical Policy Group, January 2006 (2)
Medical Policy Administration Committee, February 2006
Available for comment March 4-April 17, 2006
Medical Policy Group, September 2006 (4)
Medical Policy Administration Committee, September 2006
Available for comment September 22-November 5, 2006
Medical Policy Group, September 2008 (1)
Medical Policy Administration Committee, October 2008
Available for comment October 4-November 17, 2008
Medical Policy Group, June 2009 (1)
Medical Policy Administration Committee, July 2009
Available for comment July 2-August 15, 2009
Medical Policy Group, September 2009 (2)
Medical Policy Administration Committee, October 2009
Available for comment October 3-November 17, 2009
Medical Policy Group, February 2010 (1): Updated policy for covered and non-covered conditions, reference list
Medical Policy Administration Committee, April 2010
Available for comment April 7-May 21, 2010
Medical Policy Group, January 2012 (3): Updated Key Points and References
Medical Policy Panel, May 2013
Medical Policy Group, May 2013 (1): Update to Policy with added coverage for CAPS, myeloma with renal failure, dense deposit disease with factor H and/or C3 Nephritic factor and focal segmental glomerulosclerosis after renal transplant. Serum creatinine threshold removed from ANCA-associated vasculitis criteria; updated Key Points and References
Available for comment May 22 through July 5, 2013
Medical Policy Panel, May 2014
Medical Policy Group, June 2014 (1): Update to Key Points and References; no change to policy statement
Medical Policy Panel, May 2015
Medical Policy Group, June 2015 (3): 2015 Updates to Key Points & References; no change in policy statement (only verbiage updates added clarifying some abbreviations of conditions listed.
Medical Policy Panel, September 2017
Medical Policy Group, October 2017 (7): Updates to Key Points and References. Policy Statement- added coverage for “N-methyl-d-aspartate receptor antibody encephalitis and Progressive multifocal leukoencephalopathy associated with natalizumab.”
Medical Policy Group, November 2020 (3): Update to Key Points and References; no change to policy statement.
Medical Policy Group, August 2021 (3): Updates to Key Points and References. Policy statement updated to remove “not medically necessary”, no other changes to policy statement or intent.
A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.
Medical Policy Group, August 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.
Medical Policy Group, July 2023 (11): 2023 Updates to Key Points, Benefit Application, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.
Medical Policy Group, July 2024 (11): 2024 Updates to Key Points, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.
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.