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Apheresis Therapy
06.03.04n

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-Barré syndrome
  • Antineutrophil cytoplasmic autoantibodies (ANCA)–associated rapidly progressive glomerulonephritis (Wegener 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 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), 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 disease)
  • Paraproteinemic polyneuropathies: IgG/IgA (AFSA I), IgM
  • Posttransfusion 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 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 US Food and Drug Administration (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 two 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 nonsystemic 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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, apheresis is covered under the medical benefits of the Company's 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 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

Abboud H, Petrak A, Mealy M, et al. Treatment of acute relapses in neuromyelitis optica: Steroids alone versus steroids plus plasma exchange. Mult Scler. 2016;22(2):185-192.

Abu-Dalle I, Reljic T, Nishihori T, et al. Extracorporeal photopheresis in steroid-refractory acute or chronic graft-versus-host disease: results of a systematic review of prospective studies. Biol Blood Marrow Transplant. 2014;20(11):1677-1686.

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.

Alipour-Faz A, Shojaei M, Peyvandi H. A comparison between IVIG and plasma exchange as preparations before thymectomy in myasthenia gravis patients. 2017;117(1):245-249. 

Anderson NE, Rosenblum MK, Posner JB. Paraneoplastic cerebellar degeneration: clinical-immunological correlations. Ann Neurol. 1988;24(4):559-567.

Banerjee S, Luo P, Reda DJ, et al. Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER). Circ Cardiovasc Interv. 2020;13(8):e008933.

Baron ED, Heeger PS, Hricik DE, et al. Immunomodulatory effect of extracorporeal photopheresis after successful treatment of resistant renal allograft rejection. Photodermatol Photoimmunol Photomed. 2001;17(2):79-82.

Barr ML, Meiser BM, Eisen HJ, et al. Photopheresis for the prevention of rejection in cardiac transplantation. Photopheresis Transplantation Study Group. N Engl J Med. 1998;339(24):1744-1751.

Batgi H, Dal MS, Erkurt MA, et al. Extracorporeal photopheresis in the treatment of acute graft-versus-host disease: A multicenter experience. Transfus Apher Sci. 2021;60(5):103242.

Benden C, Haughton M, Leonard S, et al. Therapy options for chronic lung allograft dysfunction-bronchiolitis obliterans syndrome following first-line immunosuppressive strategies: A systematic review. J Heart Lung Transplant. 2017;36(9):921-933.

Benden C, Speich R, Hofbauer GF, et al. Extracorporeal photopheresis after lung transplantation: a 10-year single-center experience. Transplantation. 2008;86(11):1625-1627.

Berger M, Pessolano R, Albiani R, et al. Extracorporeal photopheresis for steroid resistant graft versus host disease in pediatric patients: a pilot single institution report. J Pediatr Hematol Oncol. 2007;29(10):678-687.

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

Bianchin G, Russi G, Romano N, et al. Treatment with HELP-apheresis in patients suffering from sudden sensorineural hearing loss: a prospective, randomized, controlled study. Laryngoscope. 2010;120(4):800-807.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Extracorporeal photopheresis for autoimmune disease. TEC Assessments. 2001;Volume 16:Tab 10.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Extracorporeal photopheresis for graft-versus-host disease. TEC Assessments. 2001;Volume 16:Tab 9.

Bonnan M, Valentino R, Olindo S, et al. Plasma exchange in severe spinal attacks associated with neuromyelitis optica spectrum disorder. Mult Scler. 2009;15(4):487-492.

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.

Buder K, Zirngibl M, Bapistella S, et al. Extracorporeal photopheresis versus alternative treatment for chronic graft-versus-host disease after haematopoietic stem cell transplantation in children and adolescents. Cochrane Database Syst Rev. 2022;6:CD009898.
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.

Carlo WF, Pearce FB, George JF, et al. Single-center experience with extracorporeal photopheresis in pediatric heart transplantation. J Heart Lung Transplant. 2014;33(6):624-628.

Cavaletti G, Perseghin P, Dassi M, et al. Extracorporeal photochemotherapy: a safety and tolerability pilot study with preliminary efficacy results in refractory relapsing-remitting multiple sclerosis. Neurol Sci. 2006;27(1):24-32.
Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 110:14: Apheresis (Therapeutic Pheresis). [CMS Web site]. Original: 02/14/86. (Revised: 07/30/92). Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=82. Accessed October 9, 2023.

Center for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 110.4: Extracorporeal Photopheresis. 2012. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=113. Accessed October 9, 2023.
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.

Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2017;2:Cd001798.

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.

Cortese I, Chaudhry V, So YT, et al. Evidence-based guideline update: Plasmapheresis in neurologic disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2011;76(3):294-300.

Costanzo-Nordin MR, Hubbell EA, O'Sullivan EJ, et al. Photopheresis versus corticosteroids in the therapy of heart transplant rejection. Preliminary clinical report. Circulation. 1992;86(5 Suppl):II242-II250.
Couser WG. Rapidly progressive glomerulonephritis: Classification, pathogenetic mechanisms, and therapy. Am J Kidney Dis.1988;11(6):449-464.

Dal MS, Batgi H, Erkurt MA, et al. Extracorporeal photopheresis in steroid-refractory chronic graft-versus-host disease: A retrospective multicenter study. Transfus Apher Sci. 2021;60(5):103243.

Dall'Amico R, Montini G, Murer L, et al. Extracorporeal photochemotherapy after cardiac transplantation: a new therapeutic approach to allograft rejection. Int J Artif Organs. 2000;23(1):49-54.

Dall'Amico R, Murer L. Extracorporeal photochemotherapy: a new therapeutic approach for allograft rejection. Transfus Apher Sci. 2002;26(3):197-204.

Dall'Amico R, Murer L, Montini G, et al. Successful treatment of recurrent rejection in renal transplant patients with photopheresis. J Am Soc Nephrol. 1998;9(1):121-127.

Danieli MG, Palmieri C, Salvi A, et al. Synchronised therapy and high-dose cyclophosphamide in proliferative lupus nephritis. J Clin Apher. 2002;17(2):72-77.

Del Fante C, Scudeller L, Oggionni T, et al. Long-Term Off-Line Extracorporeal Photochemotherapy in Patients with Chronic Lung Allograft Rejection Not Responsive to Conventional Treatment: A 10-Year Single-Centre Analysis. Respiration. 2015;90(2):118-128.

DeSena AD, Noland DK, Matevosyan K, et al. Intravenous methylprednisolone versus therapeutic plasma exchange for treatment of anti-N-methyl-D-aspartate receptor antibody encephalitis: A retrospective review. J Clin Apher. 2015;30(4):212-216.

Dignan FL, Aguilar S, Scarisbrick JJ, et al. Impact of extracorporeal photopheresis on skin scores and quality of life in patients with steroid-refractory chronic GVHD. Bone Marrow Transplant. 2014;49(5):704-708.

Donner MG, Richter WO, Schwandt P. Long term effect of LDL apheresis on coronary heart disease. Eur J Med Res. 1997;2(6):270-274.

Dwosh IL, Giles AR, Ford PM, et al. Plasmapheresis therapy in rheumatoid arthritis. A controlled, double-blind, crossover trial. N Engl J Med. 1983;308(19):1124-1129.

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.

Edelson R, Berger C, Gasparro F, et al. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. Preliminary results. N Engl J Med. 1987;316(6):297-303.

El-Bayoumi MA, El-Refaey AM, Abdelkader AM, et al. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barre syndrome: a randomized study. Crit Care. 2011;15(4):R164.

Ellingsen I, Florvaag E, Andreassen AH, et al. Plasmapheresis in the treatment of steroid-dependent bronchial asthma. Allergy. 2001;56(12):1202-1205.

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

Flowers ME, Apperley JF, van Besien K, et al. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008;112(7):2667-2674.

Foss FM, DiVenuti GM, Chin K, et al. Prospective study of extracorporeal photopheresis in steroid-refractory or steroid-resistant extensive chronic graft-versus-host disease: analysis of response and survival incorporating prognostic factors. Bone Marrow Transplant. 2005;35(12):1187-1193.

Freiman A, Sasseville D. Treatment of mycosis fungoides: overview. J Cutan Med Surg. 2006;10(5):228-233.

Fries JF, Seibold JR, Medsger TA. Photopheresis for scleroderma? No! J Rheumatol. 1992;19(7):1011-1013.

Gao C, McCormack C, van der Weyden C, et al. Prolonged survival with the early use of a novel extracorporeal photopheresis regimen in patients with Sezary syndrome. Blood. 2019;134(16):1346-1350.

Garvey MA, Snider LA, Leitman SF, et al. Treatment of Sydenham's chorea with intravenous immunoglobulin, plasma exchange, or prednisone. J Child Neurol. 2005;20(5):424-429.

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.

Gidding SS, Champagne MA, de Ferranti SD, et al. The Agenda for Familial Hypercholesterolemia: A Scientific Statement From the American Heart Association. Circulation. 2015;132(22):2167-2192.

Gokler J, Aliabadi-Zuckermann A, Zuckermann A, et al. Extracorporeal Photopheresis With Low-Dose Immunosuppression in High-Risk Heart Transplant Patients-A Pilot Study. Transpl Int. 2022;35:10320.

Greer M, Dierich M, De Wall C, et al. Phenotyping established chronic lung allograft dysfunction predicts extracorporeal photopheresis response in lung transplant patients. Am J Transplant. 2013;13(4):911-918. 

Greinix HT, Knobler RM, Worel N, et al. The effect of intensified extracorporeal photochemotherapy on long-term survival in patients with severe acute graft-versus-host disease. Haematologica. 2006;91(3):405-408.

Greinix HT, Volc-Platzer B, Knobler R. Criteria for assessing chronic GVHD. Bone Marrow Transplant. 2000;25(5):575.​​

Gubensek J, Buturovic-Ponikvar J, Kandus A, et al. Plasma exchange and intravenous immunoglobulin in the treatment of antibody-mediated rejection after kidney transplantation: a single-center historic cohort study. Transplant Proc. 2013;45(4):1524-1527.

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

Halle P, Paillard C, D'Incan M, et al. Successful extracorporeal photochemotherapy for chronic graft-versus-host disease in pediatric patients. J Hematother Stem Cell Res. 2002;11(3):501-512.
Harding AE, Thompson PD, Kocen RS, et al. Plasma exchange and immunosuppression in the stiff man syndrome. Lancet.1989;2(8668):915.

Hattori M, Chikamoto H, Akioka Y, et al. A combined low-density lipoprotein apheresis and prednisone therapy for steroid-resistant primary focal segmental glomerulosclerosis in children. Am J Kidney Dis. 2003;42(6):1121-1130. 

Hautmann AH, Wolff D, Hahn J, et al. Extracorporeal photopheresis in 62 patients with acute and chronic GVHD: results of treatment with the COBE Spectra System. Bone Marrow Transplant. 2013;48(3):439-445.

Heigl F, Hettich R, Lotz N, et al. Clinical benefit of long-term lipoprotein apheresis in patients with severe hypercholesterolemia or Lp(a)-hyperlipoproteinemia with progressive cardiovascular disease. Clin Res Cardiol Suppl. 2015;10:8-13.

Heigl F, Hettich R, Lotz N, et al. Efficacy, safety, and tolerability of long-term lipoprotein apheresis in patients with LDL- or Lp(a) hyperlipoproteinemia: Findings gathered from more than 36,000 treatments at one center in Germany. Atheroscler Suppl. 2015;18:154-162.

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.

Hivelin M, Siemionow M, Grimbert P, et al. Extracorporeal photopheresis: from solid organs to face transplantation. Transpl Immunol. 2009;21(3):117-128. 
Hoffman R, Benz EJ, Shattil SJ, et al. Hematology: Basic Principles and Practice. 4th ed. Philadelphia, PA: Churchill Livingstone; 2004.

Hughes RA, Wijdicks EF, Barohn R, et al. Practice parameter: immunotherapy for Guillain-Barre syndrome: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2003;61(6):736-740.

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.

Ipe TS, Pham HP, Williams LA, 3rd. Critical updates in the 7th edition of the American Society for Apheresis guidelines. J Clin Apher. 2018;33(1):78-94.

Jagasia M, Greinix H, Robin M, et al. Extracorporeal photopheresis versus anticytokine therapy as a second-line treatment for steroid-refractory acute GVHD: a multicenter comparative analysis. Biol Blood Marrow Transplant. 2013;19(7):1129-1133.

Jaksch P, Scheed A, Keplinger M, et al. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012;31(9):950-957.

Jardine MJ, Bhandari S, Wyburn KR, et al. Photopheresis therapy for problematic renal allograft rejection. J Clin Apher. 2009;24(4):161-169.

Jayne DR, Gaskin G, Rasmussen N, et al. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol. 2007;18(7):2180-2188.

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.

Kansu E, Ward D, Sanchez AP, et al. Extracorporeal photopheresis for the treatment of chronic graft versus host disease. Hematology. 2022;27(1):785-794.

Keehn CA, Belongie IP, Shistik G, et al. The diagnosis, staging, and treatment options for mycosis fungoides. Cancer Control. 2007;14(2):102-111.

Khatri BO, Man S, Giovannoni G, et al. Effect of plasma exchange in accelerating natalizumab clearance and restoring leukocyte function. Neurology. 2009;72(5):402-409.

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.

Kirklin JK, Brown RN, Huang ST, et al. Rejection with hemodynamic compromise: objective evidence for efficacy of photopheresis. J Heart Lung Transplant. 2006;25(3):283-288.

Kitko CL, Abdel-Azim H, Carpenter PA, et al. A Prospective, Multicenter Study of Closed-System Extracorporeal Photopheresis for Children with Steroid-Refractory Acute Graft-versus-Host Disease. Transplant Cell Ther. 2022;28(5):261.e1-261.e7. 

Kleiter I, Gahlen A, Borisow N, et al. Neuromyelitis optica: Evaluation of 871 attacks and 1,153 treatment courses. Ann Neurol. 2016;79(2):206-216. 

Knobler E. Current management strategies for cutaneous T-cell lymphoma. Clin Dermatol. 2004;22(3):197-208.

Knobler R, Duvic M, Querfeld C, et al. Long-term follow-up and survival of cutaneous T-cell lymphoma patients treated with extracorporeal photopheresis. Photodermatol Photoimmunol Photomed. 2012;28(5):250-257.

Kohler W, Bucka C, Klingel R. A randomized and controlled study comparing immunoadsorption and plasma exchange in myasthenic crisis. J Clin Apher. 2011;26(6):347-355.

Kozlov A, Estrina M, Paina O, et al. Extracorporeal Photopheresis in Children with Chronic Graft-Versus-Host Disease. Pharmaceuticals (Basel). 2021;14(8):808.

Kronbichler A, Brezina B, Quintana LF, et al. Efficacy of plasma exchange and immunoadsorption in systemic lupus erythematosus and antiphospholipid syndrome: A systematic review. Autoimmun Rev. 2016;15(1):38-49.

Kumlien G, Genberg H, Shanwell A, et al. Photopheresis for the treatment of refractory renal graft rejection. Transplantation. 2005;79(1):123-125.

Larsen FS, Schmidt LE, Bernsmeier C, et al. High-volume plasma exchange in patients with acute liver failure: An open randomised controlled trial. J Hepatol. 2016;64(1):69-78.

Leebmann J, Roeseler E, Julius U, et al. Lipoprotein apheresis in patients with maximally tolerated lipid-lowering therapy, lipoprotein(a)-hyperlipoproteinemia, and progressive cardiovascular disease: prospective observational multicenter study. Circulation. 2013;128(24):2567-2576. 

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.

Leroux J, Hirschi S, Essaydi A, et al. Initiation of extracorporeal photopheresis in lung transplant patients with mild to moderate refractory BOS: A single-center real-life experience. Respir Med Res. 2022;81:100913.

Lewis EJ, Hunsicker LG, Lan SP, et al. A controlled trial of plasmapheresis therapy in severe lupus nephritis. The Lupus Nephritis Collaborative Study Group. N Engl J Med. 1992;326(21):1373-1379. 

Lucid CE, Savani BN, Engelhardt BG, et al. Extracorporeal photopheresis in patients with refractory bronchiolitis obliterans developing after allo-SCT. Bone Marrow Transplant. 2011;46(3):426-429.

Ludvigsson J, Samuelsson U, Ernerudh J, et al. Photopheresis at onset of type 1 diabetes: a randomised, double blind, placebo controlled trial. Arch Dis Child. 2001;85(2):149-154.

Maccherini M, Diciolla F, Laghi Pasini F, et al. Photopheresis immunomodulation after heart transplantation. Transplant Proc. 2001;33(1-2):1591-1594.

Malik MI, Litzow M, Hogan W, et al. Extracorporeal photopheresis for chronic graft-versus-host disease: a systematic review and meta-analysis. Blood Res. 2014;49(2):100-106.

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Martin PJ, Rizzo JD, Wingard JR, et al. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2012;18(8):1150-1163.

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Miller FW, Leitman SF, Cronin ME, et al. Controlled trial of plasma exchange and leukapheresis in polymyositis and dermatomyositis. N Engl J Med. 1992;326(21):1380-1384. 

Miller JD, Kirkland EB, Domingo DS, et al. Review of extracorporeal photopheresis in early-stage (IA, IB, and IIA) cutaneous T-cell lymphoma. Photodermatol Photoimmunol Photomed. 2007;23(5):163-171.

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Muso E, Mune M, Fujii Y, et al. Low density lipoprotein apheresis therapy for steroid-resistant nephrotic syndrome. Kansai-FGS-Apheresis Treatment (K-FLAT) Study Group. Kidney Int Suppl. 1999;71:S122-S125.

Muso E, Mune M, Hirano T, et al. A Prospective Observational Survey on the Long-Term Effect of LDL Apheresis on Drug-Resistant Nephrotic Syndrome. Nephron Extra. 2015;5(2):58-66.

Muso E, Mune M, Hirano T, et al. Immediate therapeutic efficacy of low-density lipoprotein apheresis for drug-resistant nephrotic syndrome: evidence from the short-term results from the POLARIS Study. Clin Exp Nephrol. 2015;19(3):379-386. ​

National Cancer Institute. Mycosis Fungoides (Including Sézary Syndrome) Treatment (PDQ®)–Health Professional Version. June 27, 2023. Available at: https://www.cancer.gov/types/lymphoma/hp/mycosis-fungoides-treatment-pdq. Accessed October 9, 2023.

National Cancer Institute. Pediatric Hematopoietic Stem Cell Transplantation and Cellular Therapy for Cancer (PDQ®)–Health Professional Version. February 4, 2022. Available at: https://www.cancer.gov/types/childhood-cancers/hp-stem-cell-transplant#_5. Accessed October 9, 2023.

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Nishimura S, Sekiguchi M, Kano T, et al. Effects of intensive lipid lowering by low-density lipoprotein apheresis on regression of coronary atherosclerosis in patients with familial hypercholesterolemia: Japan Low-densityLipoprotein Apheresis Coronary Atherosclerosis Prospective Study (L-CAPS). Atherosclerosis. 1999;144(2):409-417.

Noris M, Remuzzi G. Atypical hemolytic-uremic syndrome. N Engl J Med. 2009;361(17):1676-1687. 

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Padmanabha n A, Connelly-Smith L, Aqui N, et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice - Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue. J Clin Apher. 2019;34(3):171-354.

Pagano MB, Murinson BB, Tobian AA, et al. Efficacy of therapeutic plasma exchange for treatment of stiff-person syndrome. Transfusion. J2014;54(7):1851-1856.

Papp G, Horvath IF, Barath S, et al. Immunomodulatory effects of extracorporeal photochemotherapy in systemic sclerosis. Clin Immunol. 2012;142(2):150-159.

Perfetti P, Carlier P, Strada P, et al. Extracorporeal photopheresis for the treatment of steroid refractory acute GVHD. Bone Marrow Transplant. 2008;42(9):609-617.

Perlmutter SJ, Leitman SF, Garvey MA, et al. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999;354(9185):1153-1158.

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Pham HP, Williams LA, 3rd. Therapeutic plasma exchange in two patients with stiff-person syndrome. J Clin Apher. 2016;31(5):493-494.

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Reinisch W, Knobler R, Rutgeerts PJ, et al. Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial. Inflamm Bowel Dis. 2013;19(2):293-300.​

Rietzsch H, Panzner I, Selisko T, et al. Heparin-induced Extracorporal LDL precipitation (H.E.L.P) in diabetic foot syndrome - preventive and regenerative potential?. Horm Metab Res. 2008;40(7):487-490. 

Reinisch W, Knobler R, Rutgeerts PJ, et al. Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial. Inflamm Bowel Dis. 2013;19(2):293-300.

Rimmer E, Houston BL, Kumar A, et al. The efficacy and safety of plasma exchange in patients with sepsis and septic shock: a systematic review and meta-analysis. Crit Care. 2014;18(6):699.

Rockx MA, Clark WF. Plasma exchange for treating cryoglobulinemia: a descriptive analysis. Transfus Apher Sci. 2010;42(3):247-251.

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Rubegni P, Cuccia A, Sbano P, et al. Role of extracorporeal photochemotherapy in patients with refractory chronic graft-versus-host disease. Br J Haematol. 2005;130(2):271-275.

Rubegni P, Feci L, Poggiali S, et al. Extracorporeal photopheresis: a useful therapy for patients with steroid-refractory acute graft-versus-host disease but not for the prevention of the chronic form. Br J Dermatol. 2013;169(2):450-457.

Rubegni P, Poggiali S, Cevenini G, et al. Long term follow-up results on severe recalcitrant atopic dermatitis treated with extracorporeal photochemotherapy. J Eur Acad Dermatol Venereol. 2013;27(4):523-526.

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Salvaneschi L, Perotti C, Zecca M, et al. Extracorporeal photochemotherapy for treatment of acute and chronic GVHD in childhood. Transfusion. 2001;41(10):1299-305.​

Sanders DB, Massey JM, Sanders LL, et al. A randomized trial of 3,4-diaminopyridine in Lambert-Eaton myasthenic syndrome. Neurology. 2000;54(3):603-607.

Sanli H, Akay BN, Ayyildiz E, et al. Remission of severe autoimmune bullous disorders induced by long-term extracorporeal photochemotherapy. Transfus Apher Sci. 2010;43(3):353-359.

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Scarisbrick JJ, Taylor P, Holtick U, et al. U.K. consensus statement on the use of extracorporeal photopheresis for treatment of cutaneous T-cell lymphoma and chronic graft-versus-host disease. Br J Dermatol. 2008;158(4):659-678.

Schwartz J, Padmanabhan A, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue. J Clin Apher. 2016;31(3):149-162.

Schwartz J, Winters JL, Padmanabhan A, et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: The Sixth Special Issue. J Clin Apher. 2013;28(3):145-284.

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Tsuchida H, Shigematsu H, Ishimaru S, et al. Effect of low-density lipoprotein apheresis on patients with peripheral arterial disease. Peripheral Arterial Disease LDL Apheresis Multicenter Study (P-LAS). Int Angiol. 2006;25(3):287-292.

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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
12/29/2017
11/1/2023
06.03.04
Medical Policy Bulletin
Commercial
No
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