Pheresis Therapy

Pheresis therapy is eligible for payment when performed for the indications listed below in the Text Attachment.

Payment may be made under codes 36511, 36512, 36513, and 36514, as appropriate. Indications other than those in the Text Attachment will be denied as not medically necessary and, therefore, not covered. Effective January 26, 2009, a participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Extracorporeal Immunoadsorption (ECI)

The use of Protein A columns is covered for the treatment of patients with idiopathic thrombocytopenia purpura (ITP), or for the treatment of patients with rheumatoid arthritis (RA), 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.

ECI should be reported under code 36515.

Low-Density Lipid (LDL) Apheresis

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

• patients with homozygous familial hypercholesterolemia 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. Effective January 26, 2009, a participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

LDL apheresis treatment should be reported under codes 36516, 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) 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 (36516, S2120) 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.

Treatment of Cancer-Associated Hemolytic Uremic Syndrome with Staphylococcal Protein A Immunoperfusion, Journal of Clinical Oncology, Vol.4 No. 2, February 1986

Treatment of Patients with HIV Thrombocytopenia and Hemolytic Uremic Syndrome with Protein A (Prosorba Column) Immunoadsorption Seminars in Hematology, Vol. 26, No. 2, April 1989

Treatment of Cancer Chemotherapy – Associated Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome by Protein A Immunoadsorption of Plasma, Cancer, Vol. 71, No. 5, March 1993

Brenner: Brenner & Rector’s The Kidney, 7th edition, Saunders 2004: Prognosis and Treatment

Hoffman: Hematology: Basic Principles and Practice, 4th edition, Churchill Livingstone 2005: Acquired Thrombotic Microangiopathies

Immunoadsorption in Dilated Cardiomyopathy: 6-Month Results from a Randomized Study, American heart Journal, Vol. 153, Issue 4, October 2006

Improved Protocol for Treatment of Pemphigus Vulgaris with Protein A Immunoadsorption, Clinical and Experimental Dermatology, Vol. 31, No. 6, November 2006

McPherson & Pincus: Henry’s Clinical Diagnosis and Management by Laboratory Methods, 21st edition, Saunders 2006: Indications for Therapeutic Hemapheresis

Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach from the Apheresis Applications Committee of the American Society for Apheresis, Journal of Clinical Apheresis, Vol. 22, 2007

Immunoadsorption in Severe C4d-Positive Acute Kidney Allograft Rejection: A Randomized Controlled Trial, American Journal of Transplantation, Vol. 7, No. 1, January 2007

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. Plasma exchange in the treatment of Goodpasture's Syndrome.
   
   
7. Plasma exchange in the treatment of glomerulonephritis associated with antiglomerular basement membrane antibodies and advancing renal failure or pulmonary hemorrhage.
   
   
8. Plasmapheresis in the treatment of pure red cell aplasia unresponsive to steroid and immunosuppressive therapy.
   
   
9. Plasma perfusion of charcoal filters for treatment of pruritus of cholestatic liver disease.
   
   
10. Apheresis in the treatment of chronic relapsing polyneuropathy for patients with severe or life-threatening symptoms who have failed to respond to conventional therapy.
    
    
11. Apheresis in the treatment of life-threatening scleroderma and polymyositis, when the patient is unresponsive to conventional therapy.
    
    
12. Guillain-Barré Syndrome.
    
    
13. Systemic lupus erythematosus (SLE), life threatening, as a treatment of last resort.
    
    
14. Chronic myelogenous leukemia.
    
    
15. Familial homozygous hypercholesterolemia.
    
    
16. Following solid-organ transplant, treatment of antibody-mediated rejection.
    
    
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. Plasmapheresis or plasma exchange in the last resort treatment of life threatening rheumatoid vasculitis when all other conventional therapies have failed.

NOTE:

It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage for indications 17 and 18 above.