Pheresis is a procedure utilizing specialized equipment to remove selected blood constituents (plasma or cells) from whole blood and return the remaining constituents to the person from whom the blood was taken. The terms therapeutic apheresis, plasmapheresis, and plasma exchange (PE) are often used interchangeably, but when properly used denote different procedures. 

Pheresis therapy may be considered medically necessary when performed for ANY of the following indications:

• Plasma exchange for autoimmune conditions:
  • Severe multiple manifestations of mixed cryoglobulinemia (MC) such as cryoglobulinemic nephropathy, skin ulcers, sensory motor neuropathy, and widespread vasculitis in combination with immunosuppressive treatment; or  
  • Catastrophic antiphospholipid syndrome (CAPS).
• Plasma exchange for hematologic conditions:
  • ABO incompatible hematopoietic progenitor cell transplantation; or
  • Hyperviscosity syndromes associated with multiple myeloma or Waldenstrom’s macroglobulinemia, or
  • Idiopathic thrombocytopenic purpura in emergency situations; or
  • Thrombotic thrombocytopenic purpura (TTP); or
  • Atypical hemolytic-uremic syndrome; or 
  • Post-transfusion purpura; or
  • HELLP syndrome of pregnancy (a severe form of preeclampsia, characterized by hemolysis (H), elevated liver enzymes (EL), and low platelet (LP) counts); or
  • Myeloma with acute renal failure.
• Plasma exchange for neurological conditions:
  • Guillain-Barré syndrome; or
  • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); or 
  • Multiple sclerosis (MS); acute fulminant central nervous system (CNS) demyelination; or
  • Neuromyelitis optica (NMO); or
  • Myasthenia gravis in crisis or as part of preoperative preparation; or
  • Paraproteinemia polyneuropathy; IgA, IgG.
• Plasma exchange for renal conditions:
  • Anti-glomerular basement membrane disease (Goodpasture’s syndrome); or
  • ANCA (antineutrophil cytoplasmic antibody)-associated vasculitis [e.g., Wegener’s granulomatosis, also known as granulomatosis with polyangitis (GPA)] with associated renal failure; or
  • Dense deposit disease with factor H deficiency and/or elevated C3 Nephritic factor.
• Plasma exchange for transplantation conditions:
  • Prior to solid organ transplant, treatment of patients at high risk of antibody-mediated rejection, including highly sensitized patients, and those receiving an ABO incompatible organ:
    • Kidney; or
    • Heart (infants); or
  • Renal transplantation: antibody mediated rejection; HLA [human leukocyte antigen] desensitization; or
  • Focal segmental glomerulosclerosis after renal transplant.
• Apheresis therapy for the following conditions:
  • Apheresis in the treatment of chronic relapsing polyneuropathy for patients with severe or life-threatening symptoms who have failed to respond to conventional therapy; or
  • Apheresis in the treatment of life-threatening scleroderma and polymyositis, when the patient is unresponsive to conventional therapy.
• Plasmapheresis therapy for the following conditions:
  • Plasmapheresis in the treatment of pure red cell aplasia unresponsive to steroid and immunosuppressive therapy; or
  • *Plasmapheresis or plasma exchange in the last resort treatment of life threatening rheumatoid vasculitis when all other conventional therapies have failed.
• Pheresis therapy for other conditions:
  • Familial homozygous hypercholesterolemia; or
  • Leukapheresis in the treatment of leukemia; or
  • Systemic lupus erythematosus (SLE), life threatening, as a treatment of last resort; or
  • Chronic myelogenous leukemia; or
  • Advanced prostate cancer only when used in the development of sipuleucel-T (Provenge).

It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage for this indication.

All other indications will be denied as not medically necessary.

Low-Density Lipid (LDL) apheresis may be considered medically necessary for ALL of the following indications:

• Patients with homozygous familial hypercholesterolemia as an alternative to plasmapheresis; and
• Patients with heterozygous familial hypercholesterolemia who have failed a six (6) month trial of diet therapy, and maximum tolerated combination drug therapy(*), and who meet the following FDA-approved indications:
  • Functional hypercholesterolemic heterozygotes with LDL cholesterol greater than 300 mg/dl without coronary artery disease; or
  • Functional hypercholesterolemic heterozygotes with LDL cholesterol greater than 200 mg/dl and documented coronary artery disease.

* Maximum tolerated drug therapy is defined as a trial of drugs from at least two (2) separate classes of hypolipidemic agents such as bile acid sequestrants, HMG-CoA reductase inhibitors, fibric acid derivatives, or Niacin/Nicotinic acids.

Documented coronary artery disease includes a history of myocardial infarction, coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or alternative revascularization procedure, or progressive angina documented by exercise or non-exercise stress test.

All other indications will be denied as not medically necessary.