Pheresis Therapy

Pheresis therapy is considered a "procedure of questionable current usefulness." However, it is eligible for payment when performed for the indications listed below in the Text Attachment.

Claims reporting pheresis therapy for other than the listed indications should be processed in accordance with the guidelines for procedures of questionable current usefulness (see Medical Policy Bulletin G-21).

Once medical necessity has been established, payment may be made under codes 36511, 36512, 36513, and 36514, as appropriate.

Extracorporeal Immunoadsorption (ECI)

The use of Protein A columns is covered for the treatment of patients with idiopathic thrombocytopenia purpura (ITP)(287.31), or for the treatment of patients with rheumatoid arthritis (RA)(714.0), provided that other treatment methods have been tried and failed. Other uses of these columns are currently considered experimental/investigational in nature as they have not received FDA approval.

Low-Density Lipid (LDL) Apheresis

Low-Density Lipid (LDL) apheresis is covered for the following indications:

• patients with homozygous familial hypercholesterolemia (272.0) as an alternative to plasmapheresis; and,
  
  
• patients with heterozygous familial hypercholesterolemia who have failed a 6 month trial of diet therapy, and maximum tolerated combination drug therapy(*), and who meet the following FDA-approved indications:
  
  
  1. functional hypercholesterolemic heterozygotes with LDL > 300 mg/dl
     
     
  2. functional hypercholesterolemic heterozygotes with LDL > 200 mg/dl and documented coronary artery disease.

LDL apheresis provided for any other indication is considered not medically necessary and, therefore a participating, preferred, or network provider cannot bill the member for the denied service.

LDL apheresis treatment using the dextran sulfate system (e.g., The Liposorber 15 System) should be reported under code 37799.

LDL apheresis treatment using the heparin-induced extracorporeal LDL precipitation (HELP) system should be reported under code S2120.

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

Description

Pheresis Therapy

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.

Extracorporeal Immunoadsorption (ECI)

Extracorporeal immunoadsorption (ECI)(36515, 36516) using Protein A columns (e.g., Prosorba), has been developed for the purpose of selectively removing circulating immune complexes (CIC) and immunoglobulins (IgG) from patients in whom these substances are associated with their diseases. The technique involves pumping the patient's anticoagulated venous blood through a cell separator from which 1 to 3 liters of plasma are collected and perfused over absorbent columns. The plasma rejoins the separated, unprocessed cells and is retransfused to the patient.

Low-Density Lipid (LDL) Apheresis

Most patients with high cholesterol levels can be treated using a combination of diet, exercise, and drugs. Some patients who have dangerously high cholesterol, however, do not respond to strong drug treatments.

LDL apheresis describes a variety of technologies used to acutely remove LDL from the plasma. the patient initially undergoes an apheresis procedure to isolate the plasma. The LDLs are then selectively removed from the plasma by either immunoadsorption, HELP, or dextran sulfate adsorption. LDL apheresis must be distinguished from plasma exchange (plasmapheresis). In plasma exchange the plasma is collected during a pheresis procedure, then discarded and replaced with crystalloids. In contrast, LDL apheresis is a selective procedure in which only pathogenic LDLs are removed. The plasma is then returned to the patient.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

1. Plasma exchange for acquired myasthenia gravis.



2. Plasmapheresis in the treatment of primary macroglobulinemia (Waldenstrom).



3. Leukapheresis in the treatment of leukemia.



4. Apheresis in the treatment of hyperglobulinemias, including (but not limited to) multiple myelomas, cryoglobulinemia and hyperviscosity syndromes.



5. Plasmapheresis or plasma exchange as a last resort treatment of thrombotic thrombocytopenic purpura (TTP).



6. Plasmapheresis or plasma exchange in the last resort treatment of life threatening rheumatoid vasculitis when all other conventional therapies have failed.



7. Plasma exchange in the treatment of Goodpasture's Syndrome.



8. Plasma exchange in the treatment of glomerulonephritis associated with antiglomerular basement membrane antibodies and advancing renal failure or pulmonary hemorrhage.



9. Plasmapheresis in the treatment of pure red cell aplasia unresponsive to steroid and immunosuppressive therapy.



10. Plasma perfusion of charcoal filters for treatment of pruritus of cholestatic liver disease.



11. Apheresis in the treatment of chronic relapsing polyneuropathy for patients with severe or life-threatening symptoms who have failed to respond to conventional therapy.



12. Apheresis in the treatment of life-threatening scleroderma and polymyositis, when the patient is unresponsive to conventional therapy.



13. Guillain-Barré Syndrome



14. Systemic lupus erythematosus (SLE), life threatening, as a treatment of last resort.



15. Chronic myelogenous leukemia



16. Familial homozygous hypercholesterolemia



17. 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.



18. Following solid-organ transplant, treatment of antibody-mediated rejection.