Medical Policy: 08.01.16 

Original Effective Date: February 2000 

Reviewed: May 2019 

Revised: September 2019 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

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:

Therapeutic plasmapheresis or plasma exchange (PE) is a procedure in which the plasma is isolated, then discarded or replaced with a substitution fluid such as albumin.  The goal of therapeutic plasmapheresis or plasma exchange is the removal of harmful plasma components. Theoretically, decreasing the concentration of the harmful plasma component, will improve the course of the disease. Abnormal components potentially removed with therapeutic plasmapheresis/plasma exchange (PE) include toxins, metabolic substances, and plasma components (i.e. antibodies, complement system [part of the immune system, consists of small number of proteins that are synthesized by the liver, and circulate in the blood as inactive precursors]). Therefore, diseases thought to be caused by these abnormal constituents might best be treated with this form of therapy. Diseases benefiting from plasmapheresis are largely autoimmune or neurological disorders. Plasmapheresis/plasma exchange techniques are not intended to be curative treatments for most indications. Rather, they are used to address related symptoms.

 

Therapeutic plasmapheresis/plasma exchange (PE) essentially symptomatic therapy, because it does not remove the source of the pathogenic factors. Therefore, the success of therapeutic plasmapheresis/plasma exchange will depend on whether the pathogenic substances are accessible through the circulation and whether the rate of production and transfer to the plasma component can be adequately addressed by plasmapheresis/plasma exchange.

 

Applications of therapeutic plasmapheresis/plasma exchange (PE) can be broadly subdivided into three general categories:

  • Acute self-limited diseases;
  • Acute fulminant exacergations of chronic diseases; and
  • Chronic diseases

 

In self-limited diseases and acute exacerbations of fulminant exacerbations of chronic diseases, therapeutic plasmapheresis/plasma exchange is used to acutely lower the circulating pathogenic substance. In chronic disease, there is ongoing production of pathogenic autoantibodies. Because therapeutic plasmapheresis/plasma exchange does not address underlying pathology, and, due to phenomenon of rebound antibody production, its use in chronic diseases has been less effective than in acute, self-limiting diseases. For this reason, chronic conditions are not amendable to plasmapheresis treatment.

 

The terms plasmapheresis, apheresis, and plasma exchange (PE) are often used interchangeably, however there are some differences. The American Society of Apheresis (ASFA) definitions for these procedures are as follows:

 

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: removes a smaller amount of plasma, usually less than 15% of the patient’s blood volume and therefore does not require replacement of the removed plasma.

 

Plasma Exchange (PE): is the procedure that is performed most commonly. A large volume of plasma is removed from a patient. The volume removed is such that if it were not replaced, significant hypovolemia resulting in vasomotor collapse would occur. As a result, the removed plasma must be replaced with some form of replacement fluid such as albumin.

 

Therapeutic plasmapheresis/plasma exchange (PE) are typically performed in outpatient settings, including blood banks, dialysis centers, hospital clinics, and physician’s offices. Reinfusion with human plasma may cause anaphylaxis and bleeding complications, and though rare, may require replacement of clotting factors. Therefore, plasmapheresis procedures should be performed by appropriately trained clinicians in a setting that can respond to medical emergencies at all times.

 

Summary

Peer reviewed published medical literature and medical society guidelines support the clinical effectiveness and safety of therapeutic plasmapheresis/plasma exchange (PE) for the indications listed in the policy statement below. There is evidence for the accepted indications that the use of this procedure can result in an improvement of symptoms, primarily for the acute self-limited conditions, and subsequently improve quality of life (QOL). However, based on the literature and society guidelines the evidence also is limited and/or the optimum role of therapeutic plasmapheresis/plasma exchange (PE) to remove specific autoantibodies, proteins and complements in the pathogenesis of many other conditions has not been established or the evidence demonstrated the therapy could be ineffective or harmful and therefore are considered investigational as indicated in the policy statement below.

 

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

Multiple Myeloma Version 3.2019
  • Supportive Care Treatment for Multiple Myeloma
    • Plasmapheresis should be used as adjunctive therapy for symptomatic hyperviscosity
    • Plasmapheresis for renal dysfunction (category 2B)

 

Plasmapheresis should be used as adjunctive therapy for symptomatic hyperviscosity. Institutions differ in their use of plasmapheresis for adjunctive treatment of renal dysfunction.

 

Hydration should be maintained and nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided to decrease the chances of renal dysfunction.  According to the NCCN Multiple Myeloma Panel members, the use of plasmapheresis to improve renal function is a category 2B recommendation.  The use of IV contrast media should be avoided in patients with renal impairment. Renal function should be monitored with chronic use of biophosphonates.

 

Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma Version 2.2019

Plasmaphersis should be performed for patients with symptomatic hyperviscosity, and before treatment with rituximab-containing regimen in patients with IgM ≥ 4000 mg/dl. IgM should be monitored closely in these patients thereafter and plasmapheresis should be considered again if symptomatic hyperviscosity recurs or if IgM is ≥ 4000 mg/dL while on rituximab containing therapy.

 

Primary Treatment Regimens

According to NCCN Panel, for patients requiring immediate disease control such as those with symptomatic hyperviscosity or cryoglobulinemia, initial plasmapheresis is recommended. After plasmapheresis, systemic therapy should be initiated as soon as possible.

 

Rituximab

Single agent rituximab is active in patients with WM. Transient increases in IgM titers (also called IgM flare) have been reported in 40% to 50% of patients after initiation of rituximab therapy, including in circumstances where rituximab has been used in combination therapy. The rituximab related IgM flare may lead to symptomatic hyperviscosity, as well as worsening of IgM related neuropathy, cryoglobulinemia and other IgM related complications. These levels may persist for months and do not indicate treatment failure, but may necessitate plasmapheresis to reduce hyperviscosity. Prophylactic plasmapheresis can be considered in patients with high IgM levels (typically 4,000 mg/dL or higher) before rituximab exposure to minimize risk of symptomatic hyperviscosity.

 

Treatment of IgM related Peripheral Neuropathy

The treatment of IgM related neuropathy may initially involve a course of plasmapheresis, particularly in patients with a more aggressive course of progressing peripheral neuropathy attributed to the IgM paraprotein. Typically, a course of 2 to 3 months of weekly plasmapheresis may be required before any impact on symptomatic neuropathy may be seen. Plasmapheresis, however should not be used as a permanent modality, and consolidation with chemotherapy should be considered. Post-plasmapheresis, IgM levels will return to baseline in 4 to 6 weeks.

 

American Academy of Neurology

In 2011, the American Academy of Neurology (Therapeutics and Technology Assessment Subcommittee) issued an evidence based guideline on plasmapheresis in the treatment of neurological disorders. The primary conclusions based on their evidence review are as follows:

 

Classification of Recommendations:

  • A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies)*.
  • B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or two consistent Class II studies).
  • C = Possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies).
  • U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven.

 

* In exceptional cases, one convincing Class I study may suffice for an “A” recommendation if 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome > 5 and the lower limit of the confidence interval is > 2).

 

Acute Inflammatory Demyelinating Polyneuropathy/Guillain-Barre Syndrome

What is the efficacy of plasmapheresis in the treatment of acute inflammatory demyelinating polyneuropathy (AIDP), also known as Guillain-Barre Syndrome (GBS)?
Strong evidence

Plasmapheresis should be offered in the treatment of AIDP/GBS severe enough to impair independent walking or to require mechanical ventilation (Level A).

Good evidence

Plasmapheresis should be considered in the treatment of milder clinical presentations with AIDP/GBS (Level B).

Clinical context

IV immunoglobulin (IVIg) is an alternative treatment used in patients with AIDP/GBS. There is insufficient evidence to demonstrate the superiority of one treatment over the other.

 

Chronic Inflammatory Demyelinating Neuropathy

What is the efficacy of plasmapheresis in the treatment of chronic inflammatory demyelinating neuropathy (CIDP)?
Strong evidence

Plasmapheresis should be offered as a short term treatment for patients with CIDP (Level A).

Clinical context

Steroids, IVIg, and immunosuppressants also have been used in the treatment of CIDP.

 

Dysimmune Neuropathies

What is the efficacy of plasmapheresis in the treatment of dysimmune neuropathies?
Good evidence

Plasmapheresis should be considered in polyneuropathy associated with IgA and IgG monoclonal gammopathy of undetermined significance (MGUS) (Level B).

Plasmapheresis should not be considered in the treatment of polyneuropathy associated with IgM MGUS (Level B).

 

Myasthenia Gravis

What is the efficacy of plasmapheresis in the treatment of myasthenia gravis (MG)?
Insufficient evidence

Because of lack of randomized controlled studies with masked outcomes, there is insufficient evidence to support or refute the efficacy of plasmapheresis in the treatment of myasthenic crisis (Level U) or MG prethymectomy (Level U)

 

CNS Demyelinating Disease

What is the efficacy of plasmapheresis in the treatment of CNS demyelinating disease?
Strong evidence

Plasmapheresis should not be offered for chronic progressive or secondary progressive multiple sclerosis (MS) (Level A).

Good evidence

Plasmapheresis should be considered for the adjunctive treatment of exacerbations in relapsing forms of MS (Level B).

Weak evidence

Plasmapheresis may be considered in the treatment of fulminant CNS demyelinating diseases that fail to respond to high dose corticosteroid treatment (Level C).

Clinical context

No studies on the efficacy of plasmapheresis compared to other treatment options in MS are available.

 

Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infection

What is the efficacy of plasmapheresis in the treatment of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS)?
Insufficient evidence

There is insufficient evidence to support or refute the use of plasmapheresis in the treatment of acute obsessive-compulsive disorder (OCD) and tic symptoms in the setting of PANDAS (Level U).

 

Sydenham Chorea

What is the efficacy of plasmapheresis in the treatment of Sydenham Chorea?
Insufficient evidence

There is insufficient evidence to support or refute the use of plasmapheresis in the treatment of Sydenham chorea (Level U).

 

American Society for Apheresis (ASFA)

In 2019, the American Society for Apheresis (ASFA) released the eighth special issue of their guidelines on the use of therapeutic apheresis in clinical practice. The therapeutic apheresis procedures considered in this guideline include therapeutic plasma exchange (TPE).

 

 

Category Definitions for Therapeutic Apheresis
Category Description
I Disorders for which apheresis is accepted as first line therapy, either as primary standalone treatment or in conjunction with other modes of treatment
II Disorders for which apheresis is accepted as second line therapy, either as 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 suggest apheresis to be ineffective or harmful. Institutional Review Board (IRB)approval is desirable if apheresis treatment is undertaken in these circumstances

 

Grading Recommendations: Strength and Quality of Evidence
RecommendationDescriptionQuality of EvidenceImplications
Grade 1A Strong recommendation, high quality evidence Randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation
Grade 1B Strong recommendation, moderate quality evidence Randomized controlled trials (RCTs) with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation
Grade 1C Strong recommendation, low quality or very low quality evidence Observational studies or case series Strong recommendation, but may change when higher quality evidence becomes available
Grade 2A Weak recommendation, high quality evidence Randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients’ or societal values
Grade 2B Weak recommendation, moderate quality evidence Randomized controlled trials (RCTs) with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients’ or societal values
Grade 2C Weak recommendation, low quality or very low quality evidence Observational studies or case series Very weak recommendations; other alternatives may be equally reasonable

 

Recommendations for Therapeutic Apheresis Exchange (TPE)

DiseaseTherapeutic Apheresis ModalityIndicationCategoryGrade
Acute disseminated encephalomyelitis (ADEM) TPE Steroid Refractory II 2C
Acute Inflammatory demyelinating polyradiculoneuropathy (Guillain-Barre Syndrome) TPE Primary Treatment I IA
Acute liver failure TPE III 2B
Amyloidosis, systemic TPE Other Causes IV 2C
Anti-glomerular basement membrane disease (Goodpasture’s syndrome)

TPE

 

TPE

 

TPE

Dialysis dependence and no diffuse alveolar hemorrhage (DAH)

 

Dialysis independence

 

Diffuse alveolar hemorrhage (DAH)

III

 

 

 

I

 

I

2B

 

 

 

1B

 

1C

Atopic (neuro) dermatitis (atopic eczema), recalcitrant (new in 2016)  -TPE/DFPP (double filtration plasmapheresis) III 2C
Autoimmune hemolytic anemia, severe

TPE

 

TPE

Severe cold agglutinin disease

 

Severe warm autoimmune

II

 

III

2C

 

2C

Burn shock resuscitation TPE   III 2B
Cardiac neonatal lupus  TPE   III 2C
Catastrophic antiphospholipid syndrome (CAPS) TPE   I 2C
Chronic focal encephalitis (Rasmussen encephalitis) TPE   III 2C
Chronic inflammatory demyelinating polyradiculoneuropathy  (CIDP) TPE/IA (Immunoadsorption) I 1B
Coagulation factor inhibitors TPE   III 2C
Complex regional pain syndrome TPE Chronic III 2C
Cryoglobulinemia TPE Severe/symptomatic II 2A
Dilated cardiomyopathy, idiopathic TPE NYHA II-IV III 2C
Erythropoietic protoporphyria, liver disease  TPE III 2C
Familial hypercholesterolemia TPE Homozygotes/heterozygotes II 1B
Focal segmental glomerulosclerosis (FSGS)

TPE/IA (Immunoadsorption)

 

TPE

Recurrent in kidney transplant

 

Steroid resistant in native kidney

I

 

 

III

1B

 

 

2C

Hemolysis, elevated liver function tests and low platelets (HELLP)

TPE

 

TPE

Postpartum

 

Antepartum

III

 

IV

2C

 

2C

Hemophagocytic: lymphohistocytosis (HLH); Hemophagacytic syndrome; Macrophage activating syndrome TPE III 2C
Heparin induced thrombocytopenia and thrombosis (HIT/HITT)

TPE

 

TPE

Pre-cardiopulmonary bypass

 

Thrombosis

III

 

III

2C

 

2C

Hypertriglyceridemic pancreatitis

TPE/LA (Lipoprotein apheresis)

 

TPE/LA (Lipoprotein apheresis)

Severe

 

Prevention of relapse

III

 

III

1C

 

2C

Hyperviscosity in hypergammaglobulinemia

TPE

 

TPE

Symptomatic

 

Prophylaxis for rituximab

I

 

I

1B

 

1C

IgA nephropathy (Berger’s Disease)

TPE

 

TPE

Crescentic

 

Chronic Progressive

III

 

III

2B

 

2C

Immune thrombocytopenia (ITP) TPE/IA (Immunoadsorption) Refractory III 2C
Lambert Eaton myasthenic syndrome TPE II 2C
Multiple sclerosis

TPE

 

TPE

Acute attack/relapse

 

Chronic

II

 

III

1A

 

2B

Myasthenia gravis

TPE/IA (Immunoadsorption)

 

TPE/IA (Immunoadsorption)

Acute short-term treatment

 

Long-term treatment

I

 

II

1B

 

2B

Myeloma cast nephropathy TPE II 2B
Nephrogenic systemic fibrosis

ECP/TPE

(Extracorporeal photophoresis/therapeuticplasma exchange)

III 2C
Neuromyelitis optica spectrum disorders

TPE

 

TPE

Acute attack/relapse

 

Maintenance

II

 

III

1B

 

2C

N-methyl-D-aspartate receptor antibody encephalitis TPE/IA (Immunoadsorption) I 1C
Overdose, envenomation and poisoning

TPE

 

TPE

 

TPE

Mushroom Poisoning

 

Envenomation

 

Drug overdose/poisoning

II

 

III

 

III

2C

 

2C

 

2C

Paraneoplastic neurologic syndromes TPE/IA (Immunoadsorption) III 2C
Paraproteinemic demyelinating neuropathies; chronic acquired demyelinating polyneuropathies

TPE

 

TPE

 

TPE

 

TPE

IgG/IgA/IgM

 

Anti-MAG neuropathy

 

Multiple myeloma

 

Multifocal motor neuropathy

I

 

III

 

III

 

IV

1B

 

1C

 

2C

 

1C

Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS)

TPE

 

TPE

PANDAS, exacerbation

 

Sydenham's chorea, severe

II

 

1B

1B

 

2B

Pemphigus vulgaris TPE Severe III 2B
Phytanic acid storage disease (Refsum's disease) TPE/LA (Lipoprotein apheresis) II 2C
Post transfusion purpura (PTP) TPE III 2C
Progressive multifocal leukoencephalopathy (PML) associated with natalizumab
Pruritus due to hepatobiliary disease, treatment resistant (new in 2016) TPE Treatment resistant III 1C
Psoriasis TPE Disseminated pustular IV 2C
Red cell alloimmunization prevention and treatment  TPE Pregnancy, gestational age (GA) < 20 weeks III 2C
Scleroderma (system sclerosis) TPE III 2C
Sepsis with multi-organ failure TPE III 2B
Steroid responsive encephalopathy associated with autoimmune thyroiditis (Hashimoto’s encephalopathy) TPE II 2C
Stiff person syndrome TPE III 2C
Sudden sensorineural hearing loss TPE III 2C
Systemic lupus erythematosus (SLE) TPE Severe complications II 2C
Thrombotic microangiography, coagulation mediated TPE THBD, DGKE, and PLG mutations III 2C
Thrombotic microangiography, complement mediated

TPE

 

TPE

Factor H autoantibody

 

Complement factor gene mutations

I

 

III

2C

 

2C

Thrombotic microangiography, drug associated 

TPE

 

TPE

 

TPE

Ticlopidine

 

Clopidogrel

 

Gemcitabine/Quinine

I

 

III

 

IV

2B

 

2B

 

2C

Thrombotic microangiography, infection associated 

TPE/IA (Immunoadsorption)

 

TPE

STEC-HUS severe

 

pHUS

III

 

III

2C

 

2C

Thrombotic thrombocytopenic purpura (TTP) TPE I 1A
Thrombotic microangiopathy, transplantation associated TPE III 2C
Thyroid storm TPE II 2C
Toxic epidermal necrolysis (TEN)  TPE refractory III 2B
Transplantation, cardiac

TPE

 

TPE

Desensitization

 

Antibody mediated rejection

II

 

III

1C

 

2C

Transplantation, hematopoietic stem cell, ABO incompatible (ABOi)

TPE

 

TPE

 

TPE

Major ABOi HPC(M)

 

Major ABOi HPC(A)

 

Major/Minor ABOi with pure RBC aplasia

II

 

II

 

III

1B

 

2B

 

2C

Transplantation, hematopoietic stem cell, HLA desensitization TPE III 2C
Transplantation, liver

TPE

 

TPE

Desensitization, ABOi living donor

 

Desensitization, ABOi deceased donor/antibody mediated rejection

I

 

 

III

1C

 

 

2C

Transplantation, lung TPE Antibody mediated rejection/desensitization III 2C
Transplantation, renal ABO compatible

TPE/IA (Immunoadsorption)

 

TPE/IA (Immunoadsorption)

 

TPE/IA (Immunoadsorption)

Antibody mediated rejection

 

Desensitization, living donor

 

Desensitization, deceased donor

I

 

I

 

III

1B

 

1B

 

2C

Transplantation, renal ABO incompatible

TPE/IA (Immunoadsorption)

 

TPE/IA (Immunoadsorption)

Desensitization, living donor

 

Antibody mediated rejection

I

 

II

1B

 

1B

Vasculitis, ANCA associated (AAV)

TPE

 

TPE

 

TPE

 

TPE

MPA/GPA/RLV: RPGN, Cr ≥ 5.7

 

MPA/GPA/RLV: RPGN Cr < 5.7

 

MPA/GPA/RLV: DAH

 

EGPA

I

 

 

III

 

 

I

 

III

1A

 

 

2C

 

 

1C

 

2C

Vasculitis, IgA (Henoch-Schonlein purpura)

TPE

 

TPE

Crescentic RPGN

 

Severe extrarenal manifestations

III

 

III

2C

 

2C

Vasculitis, other

TPE

 

TPE

 

TPE

Hepatitis B polyarteritis nodosa

 

Idiopathic polyarteritis nodosa

 

Behcet’s disease

II

 

 

IV

 

 

III

2C

 

 

1B

 

 

2C

Voltage gated potassium channel antibodies TPE/IA (Immunoadsorption) II 1B
Wilson disease, fulminant TPE I 1C

 

Prior Approval:

Not applicable

 

Policy:

Therapeutic plasmapheresis/plasma exchange may be considered medically necessary for any of the following conditions listed below:

  • Acute disseminated encephalomyelitis (ADEM) steroid refractory
  • Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barre syndrome)
  • Anti-glomerular basement membrane disease (Goodpasture’s syndrome)
    • Diffuse alveolar hemorrhage (DAH)
    • Dialysis independence 
  • Anti-neutrophil cytoplasmic antibodies (ANCA)-associated rapidly progressive glomerulonephritis
  • Autoimmune hemolytic uremic syndrome – severe cold agglutinin
  • Catastrophic antiphospholipid syndrome (CAPS)
  • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
  • Cryoglobulinemia severe/symptomatic
  • Familial hypercholesterolemia
  • Focal segmental glomerulosclerosis after kidney transplant
  • Hemolysis, elevated liver enzymes, and low platelets syndrome (HELLP Syndrome)
  • Hyperviscosity syndromes associated with monoclonal gammopathies (such as multiple myeloma and Waldenstrom’s macroglobulinemia)
  • Lambert-Eaton Myasthenic Syndrome
  • Multiple myeloma cast nephropathy (acute renal failure secondary to multiple myeloma)
  • Multiple sclerosis (MS)
    • For adjunctive treatment of exacerbations in relapsing forms of MS
    • In the treatment of fulminant CNS demyelinating disease that fails to respond to high dose corticosteroid treatment (as second line therapy either as standalone treatment or in conjunction with other modes of treatment)
  • Mushroom poisoning (wild mushrooms, particularly the Amanita family)
  • Myasthenia gravis 
  • Neuromyelitis optica (also known as Devic’s disease) acute attack/relapse
  • N-methyl-D-aspartate receptor antibody
  • Paraproteinemic demyelinating neuropathies with IgA, IgG or IgM monoclonal gammopathy of undetermined significance (MGUS)
  • Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS), exacerbation 
  • Pemphigus Vulgaris as second line therapy, that is resistant to standard therapy (dapsone, corticosteroids, immunosuppressants such as azathioprine or cyclosporine)
  • Phytanic acid storage disease (Refsum’s Disease)
  • Post transfusion purpura
  • Progressive multifocal leukoencephalopathy associated with natalizumab (tysarbi)
  • Steroid responsive encephalopathy associated with autoimmune thyroiditis (Hashimoto’s encephalopathy)
  • Systemic lupus erythematous (SLE) with severe complications (diffuse alveolar hemorrhage (DHA), thrombotic microangiography, hyperviscosity, cryoglobulinemia, and CNS involvement) 
  • Thrombotic microangiopathy (Factor H autoantibody) and drug associated (Ticlopidine)
  • Thrombotic thrombocytopenia purpura (TTP)
  • Thyroid storm with severe symptoms who respond poorly to first line therapeutic measures
  • Transplantation
    • Hematopoietic stem cell transplant:
      • ABO incompatible
      • Human leukocyte antigen (HLA) incompatibility with haplo-type transplant
    • Solid organ transplantation for the following:
      • Desensitization
      • Antibody-mediated rejection
      • ABO incompatible
  • Voltage gated potassium channel antibodies
  • Wilson Disease, fulminant

Therapeutic plasmapheresis/plasma exchange is considered investigational for all other conditions including, but not limited to the following, because their safety and/or effectiveness cannot be established by review of the available published peer reviewed medical literature:

  • Acute liver failure, except as indicated above for Wilson Disease
  • Amyloidosis, systemic
  • Amyotrophic lateral sclerosis (ALS)
  • Anti-glomerular basement membrane disease (Goodpasture syndrome) – dialysis dependence, no diffuse alveolar hemorrhage (DAH)
  • Aplastic anemia
  • Asthma
  • Atopic (neuro) dermatitis (atopic exzema), recalcitrant
  • Autoimmune hemolytic anemia, severe: warm autoimmune hemolytic anemia (WAHA)
  • Burn shock resuscitation
  • Cardiac neonatal lupus  
  • Chronic fatigue syndrome
  • Chronic focal encephalitis (Rasmussen Encephalitis)  
  • Coagulation factor inhibitors (alloantibody and autoantibody)
  • Complex regional pain syndrome
  • Dermatomyositis or polymyositis
  • Dilated cardiomyopathy, idiopathic (NYHA II-IV)
  • Erythropoietic protoporphyria, liver disease 
  • Focal segmental glomerulosclerosis except as indicated above
  • Henoch-Schonlein purpura
  • Hemolytic uremic syndrome (HUS)
  • Heparin induced thrombocytopenia (HIT) 
    • Pre-cardiopulmonary bypass; or
    • Heparin induced thrombocytopenia with thrombosis (HITT)
  • Hemophagocytic hymphocytosis (HLH); Hemophagocytic syndrome; Macrophage acxtivating syndrome
  • Hypertriglyceridemic pancreatitis
  • Immune complex rapidly progressive glomerulonephritis
  • Immune thrombocytopenia (refractory)
  • Immunoglobin A nephropathy (Berger's Disease)
  • Inclusion body myositis
  • Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
  • Multiple Sclerosis, except as indicated above  
  • Nephrogenic systemic fibrosis  
  • Neuromyelitis optica (Devic's syndrome) except as indicated above
  • Overdose, envenomation and poisoning
  • Paraneoplastic neurological syndromes  
  • Paraproteinemic demyelinating polyneuropathies (excedpt as indicated above) - multiple myeloma; Anti-MAG neuropathy; multifocal motor neuropathy)
  • Pediatric autoimmune neuropsychiatric disorders (PANDAS) except as indicated above
  • Pemphigus vulgaris except as indicated above
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, skin changes)
  • Progressive multifocal leukoencephalopathy associated with natalizumab (tysarbi), except as indicated above
  • Pruritus due to hepatobiliary diseases
  • Psoriasis
  • Pure red cell aplasia
  • Red cell alloimmunization in pregnancy
  • Rheumatoid arthritis
  • Schizophrenia
  • Scleroderma (progressive systemic sclerosis)
  • Sepsis with multiorgan failure
  • Status epilepticus
  • Stiff-person syndrome
  • Sudden sensorineural hearing loss
  • Sydenham's chorea
  • Systemic lupus erythematous except as indicated above
  • Thrombotic microangiopathy (except as indicated above) coagulation mediated: THBD, DGKE, and PLG mutationos; complement mediated: complement factor gene mutations; drug associated: (clopidogrel, gemcitabine or quinine); transplantation associated
  • Thyroid storm except as indicated above
  • Toxic epidermal necrolysis, refractory

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 36514 Therapeutic apheresis; for plasmapheresis.

 

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.
  • 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.
  • Mehndiratta MM & Hughes RA. Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2012 Sep 12;9:CD003906.
  • Gordon PA, Winer JB, Hoogendijk JE, Choy EH. Immunosuppressant and immunomodulatory treatment for dermatomyositis and polymyositis. Cochrane Database Syst Rev. 2012 Aug 15;8:CD003643.
  • Raphael JC, Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2012 Jul 11;7:CD001798.
  • Chhibber V & Weinstein R. Evidence-based review of therapeutic plasma exchange in neurological disorders. Semin Dial. 2012 Mar-Apr;25(2):132-9.
  • 2013 Guidelines on the use of Therapeutic Apheresis in Clinical Practice-Evidence Based Approach from the Writing Committee of the Aphersis Society for Apheresis: Sixth Special Issue; March 28, 2013: Joseph Schwartz, Jeffery L. Winters, Anand Padmanabhan, Rasheed A. Balogun, Meghan Delaney, Michael L. Linenberger, Zbigniew M. Szczepiorkowski, Mark E. Williams, Yanyun Wu, and Beth H. Shaz.
  • American Academy of Neurology: Evidence Based Guideline Update: Plasmaphoresis in Neurologic Disorders. Neurology, January 18, 2011 vol. 76 no. 3 294-300.
  • Hughes Richard, Swan Anthony, et. al. Immunotherapy for Guillain-Barre Syndrome: A Systematic Review, Brain 2007, 130, 2245-2257
  • Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Apheresis (Therapeutic Apheresis) 110.14.
  • National Comprehensive Cancer Network (NCCN) Waldenstrom’s Macroglubulinemia/Lymphoplasmacytic Lymphoma Version 2.2019.
  • National Comprehensive Cancer Network (NCCN) Multiple Myeloma Version 3.2019.
  • UpToDate. Treatment and Prognosis of Thrombotic Thrombocytopenia Pupura-Hemolytic Uremic Syndromes in Adults, Andre A Kaplan, M.D., Jamens N. George, M.D., Topic last updated February 3, 2015.
  • UpToDate. Therapeutic Apheresis (Plasma Exchange or Cytapheresis): Indications and Technology, Joy L. Fridey, M.D., Andre A. Kaplan, M.D., Topic last updated January 31, 2018.
  • UpToDate. Wilson Disease: Treatment and Prognosis, Michael L. Schilsky, M.D., FAASLD, Topic last updated November 29, 2016.
  • UpToDate. Guillain-Barre Syndrome in Adults - Treatment and Prognosis, Francine J. Vriesendorp, M.D., Topic last updated April 19, 2017.
  • UpToDate. Guillain-Barre Syndrome in Children - Treatment and Prognosis, Monique M. Ryan FRACP. Topic last updated August 29, 2016.
  • UpToDate. Approach to the Patient with Suspected Thrombotic Thrombocytopenic Purpura (TTP) or Other Thrombotic Microangiopathy (TMA), James N. Geroge, M.D., Carla Nester, MS, M.D., Topic last updated January 12, 2018.   
  • UpToDate. Treatment of Mixed Cryoglobulinemia Syndrome. Fernando C. Fervenza, M.D., PhD, Michael D Leise, M.D., Dario Raccatello, M.D., Robert A Kyle M.D., Topic last updated January 6, 2016.
  • UpToDate. Treatment of Antiphospholipid Syndrome. Peter H Schur M.D., Andre A Kaplan M.D., Topic last updated February 23, 2017.
  • UpToDate. Treatment of the Complications of Multiple Myeloma. S Vincent Rajkumar M.D., Topic last updated August 1, 2016.
  • Pagano MB, Murinson BB, Tobian AA, et al. Efficacy of therapeutic plasma exchange for treatment of stiff-personsyndrome. Transfusion. Jul 2014;54(7):1851-1856. PMID 24527774
  • Michael M, Elliott EJ, Craig JC, et al. Interventions for hemolytic uremic syndrome and thromboticthrombocytopenic purpura: a systematic review of randomized controlled trials. Am J Kidney Dis. 2009;53(2):259-272. PMID 18950913
  • Raphael JC, Chevret S, Hughes RA, et al. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2012;7:CD001798. PMID 22786475
  • 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. PMID 21745374
  • Barth D, Nabavi Nouri M, Ng E, et al. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology. Jun 7 2011;76(23):2017-2023. PMID 21562253
  • Ebadi H, Barth D, Bril V. Safety of plasma exchange therapy in patients with myasthenia gravis. Muscle Nerve. Apr 2013;47(4):510-514. PMID 23322564
  • Abboud H, Petrak A, Mealy M, et al. Treatment of acute relapses in neuromyelitis optica: Steroids alone versus steroids plus plasma exchange. Mult Scler. Apr 28 2015. PMID 25921047
  • Bonnan M, Valentino R, Olindo S, et al. Plasma exchange in severe spinal attacks associated with neuromyelitis optica spectrum disorder. Mult Scler. Apr 2009;15(4):487-492. PMID 19324982
  • 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. PMID 22776923
  • 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. PMID 21194817
  • 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. Aug 2013;84(2):397-402. PMID 23615499
  • 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. May 2013;45(4):1524-1527. PMID 23726611
  • 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. PMID 25527094  
  • 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 2016 Jun;31(3):149-62. PMID 27322218
  • The Anti-NMDA Receptor Encephalitis Foundation
  • ECRI. Custom Rapid Response Guideline. Plasmapheresis for Treatment of Multiple Sclerosis. Published April 2004, Updated October 2015.
  • UpToDate. Hashimoto Encephalopathy. Devon I Rubin M.D., Topic last updated June 17, 2015.
  • UpToDate. Recurrent and De Novo HUS after Renal Transplantation. Christina L. Klein M.D., Anuja Java M.D., Daniel C. Brennan M.D., FAC  Topic last updated November 30, 2016.
  • UpToDate. Initial Immunosuppressive Therapy in Granulomatosis with Polyangitis and Microscopic Polyangiitis. Peter A Merkel M.D., MPH, Andre A Kaplan, Ronald J Falk M.D., Topic last updated January 4, 2017.
  • UpToDate. Treatment and Prognosis of Waldenstrom Macroglobulinemia. S Vincent Rajkumar M.D., Topic last updated May 15, 2017.
  • UpToDate. Treatment and Prognosis of Kidney Disease in Multiple Myeloma and other Monoclonal Gammopathies. S Vincent Rajkumar M.D., Andrea A Kaplan M.D., Nelson Leung M.D. Topic last updated March 14, 2019.
  • UpToDate. Overview of the Treatment of Myasthenia Gravis, Shawn J Bird M.D., Topic last updated February 12, 2019.
  • UpToDate. Chronic Inflammatory Demyelinating Polyneuropathy: Treatment and Prognosis. Richard A Lewis M.D., Topic last updated December 6, 2017.
  • UpToDate. Cold Agglutinin Disease. Stanley L Schrier M.D., Topic last updated October 5, 2016.
  • UpToDate. Treatment of Lambert-Eaton Myasthenic Syndrome. David H. Weinberg M.D., Topic last updated April 26, 2016.
  • UpToDate. Hypertriglyceridemia-Induced Acute Pancreatitis. Andres Gelrud M.D., MMSc, David C Whitcomb M.D., PhD. Topic last updated July 20, 2015.
  • UpToDate. Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Demopathy in Advanced Renal Failure. Dana Miskulin M.D., Michael R Rudnick M.D. Topic last updated July 18, 2016.
  • UpToDate. Paraneoplastic and Autoimmune Encephalitis. Joseph Dalmau M.D., PhD, Myrna R. Rosenfeld M.D., PhD. Topic last updated April 7, 2017.
  • UpToDate. Overview of Paraneoplastic Syndromes of the Nervous System. Joseph Dalmau M.D., PhD, Myrna R. Rosenfeld  M.D., PhD. Topic last updated December 6, 2016.
  • UpToDate. Progressive Multifocal Leukoencephalopathy: Treatment and Prognosis. Igor J Koralnik M.D., Topic last updated April 13, 2017.
  • UpToDate. Treatment and Prognosis of Polyarteritis Nodosa. Peter A. Merkel M.D., MPH. Topic last updated November 3, 2015.
  • UpToDate. Renal Disease Associated with Hepatitis B Virus Infection. Tak-Mao Chan M.D., FRCP, Anna SF Lok M.D., Topic last updated January 11, 2016.
  • Jacobs-Kosim D, Diamond H. Polyarteritis Nodsa. January 12, 2016
  • Chen H, Masharani M. Hashimoto’s Encephalopathy.
  • Lasoff D, Corbett-Detig J, et. al. Anti-N-Methyl-D-Aspartate Receptor Encephalitis, an Underappreciated Disease in the Emergency Department. Western J Emerg Med 2016;17(3):280-282.
  • Barry H, Byrne S, et. al. Anti-N-Methyl-D-Aspartate Receptor Encephalitis: Review of the Clinical Presentation, Diagnosis and Treatment. BJPsych Bulletin (2015) 39 19-23   
  • Singh J, Saag K, Bridges L, et. al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.
  • Hahn B, McMahon M, Wilkinson A, et. al. American College of Rheumatology Guidelines for Screening, Treatment and Management of Lupus Nephritis.
  • Carr RA, Rejowski BJ, Cote GA, et. al. Systematic review of hypertriglyceridemia-induced acute pancreatitis: a more virulent etiology? Pancreatology 2016 Jul-Aug;16(4);469-76. PMID 27012480
  • Bayraktaroglu Z, Demirci F, Balat O, et. al. Plasma exchange therapy in HELLP syndrome: a single center experience. Turk J Gastroenterol 2006 Jun;17(2):99-102 PMID 16830290 
  • Clark WF. Plasma exchange for renal disease: evidence and use 2011. J Clin Apher 2012;27(3):112-6. PMID 22535650
  • Clark WF. Thrombotic microangiography: current knowledge and outcomes with plasma exchange. Semin Dial 2012 Mar-Apr;2592):214-9. PMID 22509967
  • Kohler W, Bucka C, Klingel R. A randomized and controlled study comparing immunoadsorption and plasma exchange in myasthenic crisis. J Clin Apher 2011 Dec;26(6):347-55. PMID 22095647
  • UpToDate. Acute Disseminated Encephalomyelitis in Children: Treatment and Prognosis. Timothy E. Lotze M.D., Donald J. Chadwick M.D. Topic last updated March 8, 2018. 
  • UpToDate. Acquired TTP: Treatment of Refractory or Relapsed Disease. James N. George M.D., Adam Cuker M.D., M.S. 
  • UpToDate. Evulation and Treatment of Antibody Mediated Lung Transplant Rejection. Ramsey R. Hachem M.D., Topic last updated September 7, 2017. 
  • UpToDate. Acquired TPP: Initial Treatment. James N. George M.D., Topic last updated March 29, 2019.
  • UpToDate. Treatment of Anti-GBM Antibody (Goodpasture’s) Disease. Andre A. Kaplan M.D., Gerald B. Appel M.D., Charles D. Pusey M.D.. Topic last updated December 12, 2017. 
  • UpToDate. Initial Immunosuppressive Therapy in Granulomatosis with Polyangitis and Microscopic Polyangitis. Peter A. Merkel M.D., MPH, Andre A. Kaplan M.D., Ronald J. Falk M.D., Topic last updated January 4, 2017. 
  • UpToDate. ABO Incompatibility in Kidney Transplantation. Christina L. Klein M.D., Daniel C. Brennan M.D., FACP. Topic last updated January 28, 2019. 
  • UpToDate. Approach to the Patient with Suspected TTP, HUS or Other Thromobotic Microangiopathy (TMA). James N George M.D., Carla Nester M.S., M.D., Topic last updated March 29, 2019. 
  • UpToDate. Treatment and Prognosis of Shiga Toxin-Producing Escherichia Coli (STEC) Hemolytic Uremic Solution (HUS) in Children. Patrick Niaudet M.D., Olivia Boyer M.D., PhD. Topic last updated February 5, 2019. 
  • UpToDate. Treatment of Acute Exacerbations of Multiple Sclerosis in Adults. Michael J. Olek D.O., Jonathan Howard M.D., October 9, 2018. 
  • UpToDate. Management of Refractory Pemphigus Vulgaris and Pemphigus Foliaceus. Michael Hertl M.D., Rudiger Eming M.D., Topic last updated September 13, 2018. 
  • UpToDate. HLA Desensitization in Kidney Transplantation. Edmund Huang M.D., Stanley C. Jordan M.D., FASN, FAST. Topic last updated March 20, 2019. 
  • Yu X, Gan L, Wang Z, et. al. Chemotherapy with or without plasmapheresis in acute renal failure due to multiple myeloma: a meta analysis. Int J Clin Pharmacol Ther 2015 May;53(5):391-7. PMID 25816886
  • Weiss PF, Klink AJ, Friedman DF, et. al. Pediatric therapeutic plasma exchange indications and patterns of use in U.S. children’s hospitals. J Clinc Apher 2012;27(6):287-94. PMID 22811262
  • 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 2014 Dec 20;18(6):699 PMID 25527094
  • Hildebrand AM, Huang SH, Clark WF. Plasma exchange for kidney disease. What is the best evidence? Adv Chronic Kidney Dis 2014 Mar;21(2):217-27
  • Pagano MB, Murinson BB, Tobian AA, et. al. Efficacy of therapeutic plasma exchange for treatment of stiff person syndrome. Transfusion 2014 Jul;54(7):1851-6. PMID 24527774
  • Click B, Ketchum AM, Turner R, et, al. The role of apheresis in hypertriglyceridemia-induced acute pancreatitis: A systematic review. Pancreatology 2015 Jul-Aug;15(4):313-20. PMID 25800175
  • Stork AC, Lunn MP, Nobile-Orazio E, et. al. Treatment of IgG and IgA paraproteinamic neuropathy. Cochran Database Syst Rev 2015 Mar 24(3):CD005376. PMID 25803231
  • 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 2016 Jan;15(1):38-49. PMID 26318215
  • Zeiler FA, Matuszczak M, Teitelbaum J, et. al. Plasmapheresis for refractory status epilepticus, part I: A scoping systematic review of the adult literature. Seizure 2016 Dec;43:14-22. PMID 27792912
  • Zeiler FA, Matuszczak M, Teitelbaum J, et. al. Plasmapheresis for refractory status epilepticus part II: A scoping systematic review of the pediatric literature. Seizure 2016 Dec;43:61-68. PMID 27888743
  • Ridel C, Kissling S, Mesnard L, et. al. Plasma exchange in nephrology: indications and technique. Nephrol Ther 2017 Feb;13(1):43-55. PMID 28110970
  • Joglkar K, Brannick B, Kadaria D, et. al. Therapeutic plasmapheresis for hypertriglyceridemia-associated acute pancreatitis: case series and review of the literature. Ther Adv Endocrinol Metab 2017 Apr;8(4):59-65. PMID 2857728
  • Tyler K, Vollmer T. To PLEX or not to PLEX in natalizumab-associated PML. Neurology March 21 2017;88 (12)
  • 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 of Apheresis: The Eighth Special Issue J Clin Apher May 2019;34:171-354
  • Colvin M, Cook J, Chang P, et, al. Sensitization in heart transplantation: emerging knowledge. Circulation 20189;139:e553-e578
  • Kobashigawa J, Patel J, Kittleson M, et. al. The long-term outcome of treated sensitized patients who undergo heart transplantation. Clin Transplant 2011;25(1)
  • Colvin M, Cook J, Chang P. Antibody mediated rejection in cardiac transplantation: emerging knowledge in diagnosis and management. Circulation 2015;131:1608-1639
  • Kittleson M, Kobashigawa J. Management of the healthy sensitized patient awaiting heart transplant. American College of Cardiology.
  • Kobashigawa J, Colvin M, Potena L, et. al. The management of antibodies in heart transplantation: an ISHLT consensus document. The Journal of Heart and Lung Transplantation May 2018 Volume 37 Issue 5 537-547
  • Abdo AS, Cook DJ, McCarthy JF, et. al. The Journal of Heart and Lung Transplantation February 2001 Volume 20 Issue 2 194
  • Leech SH, Lopez-Cepero M, LeFor WM, et. al. Management of the sensitized cardiac recipient: the use of plasmapheresis and intravenous immunoglobulin. Clin Transplant 2006 Jul-Aug;20(4):476-84. PMID 16842525
  • Crabbe A, McNeil J, Deshpande S, et. al. Therapeutic plasma exchange in heart transplantation: role of coagulation assessment with throboelastometry. JA Clin Rep 2016;2(1):31
  • Chih S,  Patel J. Desensitization strategies in adult heart transplantation will persistence pay off? The Journal of Heart and Lung Transplantation Vol 35 No 8 August 2016
  • Geft D, Kobashigawa J. Current concepts for sensitized patients before transplantation. Curr Opin Organ Transplant 2017 Jun;22(3):236-241. PMID 28306593
  • Chang DH, Kobashigawa JA. Desensitization strategies in the patient awaiting heart transplantation. Curr Opin Cardiol 2017 Feb 15. PMID 28212150 
  • UpToDate. Acute Cardiac Allograft Rejection: Diagnosis. Howard J. Eisen M.D., FACC, FAHA, FAST. Topic last updated June 27, 2018.
  • UpToDate. Prevention and Treatment of Antibody Mediated Rejection of the Renal Allograft. Arjang Djamali M.D., MS, FASN, Daniel C. Brennan M.D., FACP.
  • UpToDate. Evaluation and Treatment of Acute Lung Transplant Rejection. Joseph Pilweksi M.D. Topic last updated October 9, 2018.
  • UpToDate. Evaluation and Treatment of Antibody Mediated Lung Transplant Rejection. Ramsy R. Hachem M.D.. Topic last updated July 15, 2019.
  • UpToDate. Acute Cardiac Allograft Rejection: Treatment. Howard J. Eisen M.D., FACC, FAHA, FAST. Topic last updated January 5, 2018.
  • UpToDate. Pancreas Allograft Rejection. Tarek Alhamad M.D., MS, FACP, FASN, Aleksandra Kukla M.D., Robert J. Stratta, M.D., Topic last updated May 24, 2018.

 

Policy History:

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