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Apheresis Therapy
MA06.001e

Policy

MEDICALLY NECESSARY

Plasmapheresis (plasma exchange) is considered medically necessary and, therefore, covered for the treatment of the following conditions:
  • ABO-incompatible hematopoietic progenitor cell transplantation
  • Acute central nervous system (CNS) inflammatory demyelinating disease refractory to corticosteroid therapy
  • Acute humoral rejection following kidney transplantation
  • Acute fulminant CNS demyelination, associated with multiple sclerosis or other conditions (e.g., transverse myelitis) refractory to corticosteroid therapy
  • Acute inflammatory demyelinating polyradiculoneuropathy, including Guillain-Barre syndrome
  • Antineutrophil cytoplasmic autoantibodies (ANCA)--associated rapidly progressive glomerulonephritis (Wegener's granulomatosis)
  • Antibody-mediated rejection following solid-organ transplantation
  • Autoimmune hemolytic anemia
  • Catastrophic antiphospholipid syndrome (CAPS)
  • Chronic inflammatory demyelinating polyneuropathy (CIDP) or chronic relapsing polyneuropathy for individuals with severe or life-threatening symptoms who have failed conventional therapy (e.g., prednisone, intravenous immunoglobulins [IVIG])
  • Chronic inflammatory demyelinating polyradiculoneuropathy
  • Coagulation factor inhibitors
  • Cryoglobulinemia
  • Demyelinating polyneuropathy with IgG and IgA antibodies
  • Dense deposit disease with factor H deficiency and/or elevated C3 nephritic factor
  • Glomerulonephritis associated with antiglomerular basement membrane antibodies and advancing renal failure or pulmonary hemorrhage
  • Goodpasture’s syndrome
  • HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome of pregnancy
  • Hemolytic uremic syndrome
  • Hyperglobulinemias, including (but not limited to) multiple myelomas, cryoglobulinemia, and hyperviscosity syndromes
  • Idiopathic thrombocytopenic purpura (ITP)
  • Lambert-Eaton myasthenic syndrome
  • Familial hypercholesterolemia
  • Macroglobulinemia (Waldenstrom's), primary
  • Myasthenia gravis, acquired
  • Myeloma with acute renal failure
  • Mushroom poisoning (wild mushrooms, particularly the Amanita family)
  • Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections
  • Phytanic acid storage disease (Refsum's disease)
  • Polyneuropathy with IgM antibody (with or without Waldenstrom's disease)
  • Paraproteinemic polyneuropathies: IgG/IgA (AFSA I), IgM
  • Post-transfusion purpura
  • Prior to solid organ transplantation for the treatment of individuals at high risk for antibody-mediated rejection, including highly sensitized individuals and those receiving an ABO-incompatible organ kidney, heart [infants])
  • Rasmussen's encephalitis
  • Red cell alloimmunization in pregnancy
  • Renal transplantation: antibody-mediated rejection and HLA desensitization
  • Rheumatoid vasculitis (life-threatening), last-resort treatment
  • Scleroderma (life-threatening) and polymyositis when the individual has been unresponsive to conventional therapy
  • Syndenham’s chorea (severe)
  • Systemic lupus erythematosus [SLE] (life-threatening), last-resort treatment when conventional therapy has failed to prevent clinical deterioration
  • Thrombotic thrombocytopenic purpura (TTP)
Low-Density Lipoprotein (LDL) Apheresis is considered medically necessary in individuals with proven 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 (all LDL levels represent the best achievable LDL level after a program of diet and drug therapy):
  • Proven familial hypercholesterolemia with LDL > 300 mg/dL
  • Proven familial hypercholesterolemia with LDL > 200 mg/dL AND documented coronary artery disease**​
*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.

**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.

Frequency of LDL apheresis varies, but typically averages about once every 2 weeks to obtain an interapheresis level of LDL cholesterol at less than 120 mg/dL. Patients with homozygous FH may be treated more frequently. Patients are simultaneously treated with diet and drug therapy.

Lymphoplasmapheresis is considered medically necessary and, therefore, covered for the treatment of rheumatoid arthritis.

Plasma perfusion of charcoal filters is considered medically necessary and, therefore, covered for the treatment of pruritus in cholestatic liver disease.

Leukopheresis (Leukocytapheresis, Leukapheresis) is considered medically necessary and, therefore, covered for the following:
  • To treat individuals who have leukemia
  • Hyperleukocytosis: leukostasis
  • To collect stem cells from individuals who are undergoing autologous stem cell transplantation
  • To collect cells from individuals who are donating for allogeneic transplantation
Erythrocytapheresis is considered medically necessary and, therefore, covered for the treatment of the following conditions:
  • Babesiosis (severe)
  • Erythrocytosis/polycythemia vera (after an inadequate response to phlebotomy)
  • Refractory iron overload due to chronic blood transfusions when conventional chelation therapy has been ineffective
  • Sickle cell diseases: life- and organ-threatening; stroke prophylaxis; prevention of iron overload
  • Malaria (severe)
Thrombocytapheresis is considered medically necessary and, therefore, covered for the treatment of thrombocytosis (symptomatic).

Extracorporeal Photopheresis is considered medically necessary and, therefore, covered for the following:
  • The palliative treatment of skin manifestations of two subcategories of cutaneous T-cell lymphoma (i.e., Sézary syndrome and mycosis fungoides) that are refractory to medical therapy, including chemotherapy and radiotherapy)
  • The treatment of late-stage (III/IV) cutaneous T-cell lymphoma or progressive early-stage (I/II) cutaneous T-cell lymphoma that is refractory to non-systemic therapies
  • The treatment of cardiac allograft rejection, including acute allograft rejection, that is either refractory to standard immunosuppressive drug treatment (which may include, but is not limited to, corticosteroids, antithymocyte globulin, or the murine monoclonal antibody OKT3), or recurrent cardiac allograft rejection.
  • The treatment of acute and chronic graft-versus-host disease (GVHD) that is refractory to standard immunosuppressive drug treatment (which may include, but is not limited to, an alternating regimen of prednisone and cyclosporine)
Apheresis therapy is only considered medically necessary for the collection and storage of stem cells for a future stem cell transplantation when the stem cell transplantation meets the medical necessity criteria listed in the Company's policy addressing stem cell transplantation.

When apheresis therapy is performed in the hospital setting (either inpatient or outpatient), nonphysician services furnished to hospital patients are covered and paid for as hospital services. When covered services are provided to hospital patients by an outside provider/supplier, the hospital is responsible for paying the provider/supplier for these services.

When apheresis therapy is performed in a nonhospital setting (e.g., a physician-directed clinic/office), all of the following criteria must be met:
  • A professional provider (or a number of professional providers) is/are present to perform medical services and to respond to medical emergencies at all times during patient-care hours.
  • Each individual is under the care of a professional provider.
  • All nonphysician services are furnished under the direct supervision of a professional provider.
EXPERIMENTAL/INVESTIGATIONAL

All other uses for apheresis therapy are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, apheresis is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the US Food and Drug Administration (FDA) for apheresis.

Description

Apheresis therapy, also known as pheresis or therapeutic pheresis, is a medical procedure that utilizes specialized equipment to remove selected components from whole blood. These components may include plasma, leukocytes (white blood cells), erythrocytes (red blood cells), and platelets, as well as other circulating substances that may be responsible for the disease process. Once the targeted components are removed, the remaining components are re-transfused into the person from whom the blood was taken. The goal of apheresis is to improve the individual's condition by removing toxic substances from the blood. Apheresis is considered an autologous procedure because the blood removed from an individual is returned to the same individual after processing.

Plasmapheresis, or plasma exchange (PE), is the most frequently performed apheresis procedure; it involves the separation of plasma and blood cells from whole blood. Once the plasma is isolated and treated, the blood cells are recombined with the individual’s plasma, a plasma substitute, or donor plasma, and returned to the individual.

Other types of apheresis therapy include:
  • Cytapheresis (removal of a cellular component from blood), which includes leukapheresis (white cell removal), thrombocytapheresis (platelet removal), and erythrocytapheresis (red cell removal)
  • Lymphoplasmapheresis (plasma and lymphocyte [a type of white blood cell] removal)
  • Plasma perfusion of charcoal filters (plasma is passed over charcoal filters to remove toxins)
  • Low-density lipoprotein (LDL) apheresis
  • Extracorporeal photopheresis

References

Adams DM, Schultz WH, Ware RE, Kinney TR. Erythrocytapheresis can reduce iron overload and prevent the need for chelation therapy in chronically transfused pediatric patients. J Pediatr Hematol Oncol.1996;18(1):46-50.

Beutler E, Lichtman MA, Coller BS, et al.Williams Hematology. 6th ed. New York, NY: McGraw Hill; 2000.

Brashear HR, Phillips LH. Autoantibodies to GABAergic neurons and response to plasmapheresis in stiff-man syndrome. Neurology.1991;41(10):1588-1592.

Brunskill SJ, Tusold A, Benjamin S, et al. A systematic review of randomized controlled trials for plasma exchange in the treatment of thrombotic throbocytopenic purpura. Transfus Med. 2007;17(1):17-35.

Canadian Cooperative Multiple Sclerosis Study Group. The Canadian cooperative trial of cyclophosphamide and plasma exchange in progressive multiple sclerosis. Lancet.1991;337(8739):441-446.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination. 110:14: Apheresis (therapeutic pheresis). [CMS Web site]. Original: 02/14/86. (Revised: 07/30/92). Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=82&ncdver=1&DocID=110.14&bc=gAAAABAAAAAA&. Accessed July 27, 2015.

Cesana M, Mandelli C, Tiribelli C, et al. Concomitant primary hemochromatosis and beta-thalessemia trait: Iron depletion by erythrocytapheresis and desferrioxamine. Am J Gastroenterol. 1989;84(2):150-152.

Cole E, Cattran D, Magil A, et al. A prospective randomized trial of plasma exchange as additive therapy in idiopathic crescentic glomerulonephritis. The Canadian Apheresis Group. Am J. Kidney Dis.1992;20(3):261-269.

Couser WG. Rapidly progressive glomerulonephritis: Classification, pathogenetic mechanisms, and therapy. Am J Kidney Dis.1988;11(6):449-464.

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(22):1482-1486.

Ellingsen I, Florvaag E, Andreassen AH, et al. Plasmapheresis in the treatment of steroid-dependent bronchial asthma. Allergy.2001;56(12):1202-1215.

Fernandez C. Evaluating pediatric apheresis toxicity. Transfus Apher Sci. 2002;26(3):175.

George JN, Kremer Hovinga JA, Terrell DR, et al. The Oklahoma thrombotic thrombocytopenic purpura-hemolytic uremic syndrome registry: the Swiss connection. Eur J Haematol. 2008:80(4):277-286.

Guillaume JC, Roujeau JC, Morel P, et al. Controlled study of plasma exchange in pemphigus. Arch Dermatol.1988;124(11):1659-1663.

Harding AE, Thompson PD, Kocen RS, et al. Plasma exchange and immunosuppression in the stiff man syndrome. Lancet.1989;2(8668):915.

Hilliard LM, Williams BF, Lounsbury AE, Howard TF. Erythrocytapheresis limits iron accumulation in chronically transfused sickle cell patients. Am J Hematol.1998;59(1):28-35.

Hoffman R, Benz EJ, Shattil SJ, et al. Hematology: Basic Principles and Practice. 4th ed. Philadelphia, PA: Churchill Livingstone; 2004.

Ibernon M, Gil-Vernet S, Carrera M, et al. Therapy with plasmapheresis and intravenous immunoglobulin for acute humoral rejection in kidney transplantation. Transplant Proc.2005;37(9):3743-3745.

Jordan SC, Vo AA, Nast CC, Tyan D. Use of high-dose human intravenous immunoglobulin therapy in sensitized patients awaiting transplantation: The Cedars-Sinai experience. Clin Transpl.2003;193-198.

Jordan SC, Vo AA, Tyan D, et al. Current approaches to treatment of antibody-mediated rejection. Pediatr Transplant.2005;9(3):408-415.

Kanold J, Merlin E, Halle P, et al. Photopheresis in pediatric graft-versus-host disease after allogeneic marrow transplantation: clinical practice guidelines based on field experience and review of the literature. Transfusion. 2007;47(12):2276-2289.

Khatri BO, McQuillen MP, Harrington GJ, et al. Chronic progressive multiple sclerosis: Double-blind controlled study of plasmapheresis in patients taking immunosuppressive drugs. Neurology.1985;35(3):312-319.

Kim HC, Dugan NP, Silber JH, et al. Erythrocytapheresis therapy to reduce iron overload in chronically transfused patients with sickle cell disease. Blood.1994;83(4):1136-1142.

Lehrich RW, Rocha PN, Reinsmoen N, et al. Intravenous immunoglobulin and plasmapheresis in acute humoral rejection: Experience in renal allograft transplantation. Hum Immunol.2005;66(4):350-358.

McLeod BC. Evidence based therapeutic apheresis in autoimmune and other hemolytic anemias. Curr Opin Hematol. 2007;14(6):647-654.

Michon B, Moghrabi A, Winikoff R, et al. Complications of apheresis in children. Transfusion. 2007;47:(10):1837-1842.

McCarthy LJ, Danielson CFM, Fernandez C, et al. Intensive plasma exchange for severe autoimmune hemolytic anemia in a four-month-old infant. J Clin Apher.1999;14(4):190-192.

McLeod BC. Introduction to the third special issue: Clinical applications of therapeutic apheresis. J Clin Apher. 2000;15(1-2):1-5.

Montgomery RA, Zachary AA. Transplanting patients with a positive donor-specific crossmatch: A single center's perspective. Pediatr Transpl.2004;8(6):535-542.

Murrin RJ, Murray JA. Thrombotic thrombocytopenic purpura: Aetiology, pathophysiology and treatment. Blood Rev.2006;20(1):51-60.

Shah A, Nadasdy T, Arend L, et al. Treatment of C4d-positive acute humoral reaction with plasmapheresis and rabbit polyclonal antithymocyte globulin. Transplantation.2004;77(9):1399-1405.

Shishido S, Hasegawa A. Current status of ABO-incompatible kidney transplantation in children. Pediatr Transplant.2005;9(2):148-154.

Shumak KH, Rock GA. Therapeutic plasma exchange. N Engl J Med.1984;310(12):762-771.

Siami FS, Siami GA. A last resort modality using cryofiltration apheresis for the treatment of cold hemagglutinin disease in a Veterans Administration hospital. Ther Apher Dial. 2004;8(5):398-403.

Singer ST, Quirolo K, Nishi K, et al. Erythrocytapheresis for chronically transfused children with sickle cell disease: An effective method for maintaining a low hemoglobin S level and reducing iron overload. J Clin Apher.1999;14(3):122-125.

Smith JW, Weinstein R, AABB Hemapheresis Committee. Therapeutic apheresis: A summary of current indication categories endorsed by the AABB and the American Society for Apheresis. Transfusion.2003;43(6):820-822.

Szczepiorkowski ZM, Shaz BH, Bandarenko N, Winters JL. The new approach to assignment of ASFA categories. Introduction to the Fourth Special Issue: Clinical Applications of THereapeutic Apheresis. J Clin Apher. 22(3):96-105.

Szczepiorkowski ZM, Bandarenko N, Kim HC, et al. Guidelines on the use of therapeutic apheresis in clinical practice–evidence-based approach from the apheresis applications committee of the American Society for Apheresis. J Clin Apher. 2007;22(3):106-175.

Tanabe K, Takahashi K, Sonda K, et al. Long-term results of ABO-incompatible living kidney transplantation: A single-center experience. Transplantation.1998;65(2):224-228.

Therapeutics and Technology Assessment. Subcommittee of the American Academy of Neurology. Assessment of plasmapheresis. Neurology.1996;47(3):840-843.

US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. COBE Spectra Apheresis System & Trima Automated Blood Component Collection System. 510(k) approval letter. [FDA Web site]. 03/15/05. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm076629.htm. Accessed July 7, 2015.

US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Haemonetics MCS+8150 Apheresis System. 510(k) approval letter. [FDA Web site]. 07/12/04. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm078326.htm. Accessed July 27, 2015.

Vicari AM, Folli F, Pozza G, et al. Plasmapheresis in the treatment of stiff-man syndrome. N Engl J Med.1989;320(22):1499.

Weiner HL, Dau PC, Khatri BO, et al. Double-blind study of true vs sham plasma exchange in patients treated with immunosuppression for acute attacks of multiple sclerosis. Neurology.1989;39(9):1143-1149.

Weinshenker BG, O'Brien PC, Petterson TM, et al. A randomized trial of plasma exchange in acute central nervous system inflammatory demyelinating disease. Ann Neurol.1999;46(6):878-886.

Winters JL, Gloor JM, Pineda AA, et al. Plasma exchange conditioning for ABO-incompatible renal transplantation. J Clin Apher.2004;19(2):79-85.

Coding

CPT Procedure Code Number(s)
\MEDICALLY NECESSARY
36511, 36512, 36513, 36514, 36516, 36522

EXPERIMENTAL/INVESTIGATIONAL
0342T
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)
P9034 Platelets, pheresis, each unit

P9035 Platelets, pheresis, leukocytes reduced, each unit

P9036 Platelets, pheresis, irradiated, each unit

P9037 Platelets, pheresis, leukocytes reduced, irradiated, each unit

P9050 Granulocytes, pheresis, each unit

P9052 Platelets, HLA-matched leukocytes reduced, apheresis/pheresis, each unit

P9053 Platelets, pheresis, leukocytes reduced, CMV-negative, irradiated, each unit

P9055 Platelets, leukocytes reduced, CMV-negative, apheresis/pheresis, each unit

P9073 Platelets, pheresis, pathogen-reduced, each unit

P9100 Pathogen(s) test for platelets

S2120 Low density lipoprotein (LDL) apheresis using heparin-induced extracorporeal LDL precipitation
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

1/1/2018
1/2/2018
12/18/2020
MA06.001
Medical Policy Bulletin
Medicare Advantage
No
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