| Mountain State Medical Policy Bulletin |
| Section: | Surgery |
| Number: | S-11 |
| Topic: | Pheresis Therapy/ECI |
| Effective Date: | October 1, 2008 |
| Issued Date: | January 26, 2009 |
| Date Last Reviewed: | 09/2008 |
Indications and Limitations of Coverage
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)(287.31), or for the treatment of patients with rheumatoid arthritis (RA)(714.0, 714.1, 714.2), 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:
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. |
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| 36511 | 36512 | 36513 | 36514 | 36515 | 36516 |
| S2120 |
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 |
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