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Medical Policy: 08.01.09
Original Effective Date: December 2000
Reviewed: November 2011
Revised: September 2010
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Extracorporeal photopheresis (ECP) is a leukapheresis-based immunomodulatory procedure that involves the following steps: the patient’s blood is collected and the leukocyte-rich portion is separated, the photosensitizer agent 8-methoxypsoralen (8-MOP) is added to the lymphocyte fraction, which is then exposed to ultraviolet A light, and the light-sensitized lymphocytes are reinfused into the patient.
Treatment of Graft-versus-Host Disease
ECP as a treatment of graft-versus-host disease (GVHD) after a prior allogeneic stem-cell transplant is based on the fact that GVHD is an immunologically mediated disease. GVHD can be categorized into acute disease, occurring within the first 100 days after infusion of allogeneic cells, or chronic disease, which develops some time after 100 days. Acute GVHD is commonly graded from I-IV, ranging from mild disease, which is characterized by a skin rash without involvement of the liver or gut, to grades III and IV, which are characterized by generalized erythroderma, elevated bilirubin levels or diarrhea. Chronic GVHD typically presents with more divers symptoms resembling autoimmune diseases such as progressive systemic sclerosis, systemic lupus erythematosus, or rheumatoid arthritis. It may affect the mouth, eyes, respiratory tract, musculoskeletal system, peripheral nerves, as well as the skin, liver, or gut.
Treatment of Organ Transplant Rejection
The standard of care for treatment of organ transplant rejection is immunosuppression, with the particular regimen dictated by the organ being transplanted. Immunosuppression is used to lower the responsiveness of the organ recipient’s immune system thereby decreasing the likelihood of rejection. Although the specific mechanism of ECP is not known, the reinfusion of treated leukocytes seems to specifically suppress the immune response to the donor organ, while maintaining the body’s ability to respond to other antigens. The specificity of ECP to target the immune response to the transplanted organ allows ECP to decrease organ rejection without an increased risk of infection, common with immunosuppressant drugs.
Treatment of Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma (CTCL) is a neoplasia of malignant T-lymphocytes that initially present as skin involvement. CTCL is extremely rare, with an estimated incidence of about 0.4 per 100,000 annually but, because most are low-grade malignancies with long survival, the overall prevalence is much higher. Two variants, mycosis fungoides and Sézary syndrome, account for approximately 60% and 5% of new cases, respectively. Appropriate therapy of CTCL depends on a variety of factors, including stage, patient’s overall health, and the presence of symptoms. Therapies can be categorized into topical and systemic treatments that include ECP.
Treatment of Autoimmune Disease
The use of ECP as a treatment of autoimmune disease is based on the premise that pathogenic lymphocytes form an expanded clone of cells, which are damaged when exposed to UV light in the presence of 8-MOP. It is hypothesized that the resulting damage induces a population of circulating suppressor T cells targeted against the light-damaged cells. It is further hypothesized that these suppressor T-cells are targeted as a component of the cell that is common to the entire clone of abnormal cells (i.e., not just the light-sensitized cells), thus inducing a systemic effect. However, although scleroderma and other autoimmune diseases are associated with the presence of circulating antibodies, it is not certain how these antibodies are related to the pathogenesis of the disease, and photopheresis is not associated with consistent changes in autoantibody levels.
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Prior Approval:
Not applicable
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Policy:
Graft-versus-Host Disease
Extracorporeal photopheresis may be considered medically necessary as a technique to treat chronic graft-versus-host disease that is refractory to medical therapy.
Extracorporeal photopheresis is considered investigational as a technique to treat acute graft-versus-host disease or chronic graft-versus-host disease that is either previously untreated or is responding to established therapies.
Organ Transplant Rejection
Extracorporeal photopheresis may be considered medically necessary to treat cardiac allograft rejection, including acute rejection, that is either recurrent or that is refractory to standard immunosuppressive drug treatment.
Extracorporeal photopheresis is considered investigational in all other situations related to treatment or prevention of rejection in solid-organ transplantation.
Cutaneous T-cell Lymphoma
Extracorporeal photopheresis may be considered medically necessary as a technique to treat late-stage (III/IV) cutaneous T-cell lymphoma.
Extracorporeal photopheresis may be considered medically necessary as a technique to treat early-stage (I/II) cutaneous T-cell lymphoma that is progressive and refractory to established nonsystemic therapies.
Extracorporeal photopheresis is considered investigational as a technique to treat early stage (I/II) cutaneous T-cell lymphoma that is either previously untreated or is respnding to established nonsystemic therapies.
Autoimmune Diseases
Extracorporeal photopheresis is considered investigational as a technique to treat either the cutaneous or visceral manifestations of autoimmune diseases, including but not limited to:
- progressive systemic sclerosis (scleroderma)
- systemic lupus erythematosus
- rheumatoid arthritis
- pemphigus and other autoimmune bullous diseases
- psoriasis
- psoriatic arthritis or psoriasis vulgaris
- multiple sclerosis
- type 1 diabetes mellitus
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 36522 Photopheresis, extracorporeal
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Selected References:
- Enomoto DN, Mekkes JR, Bossuyt PM, et al. Treatment of patients with systemic sclerosis with extracorporeal photochemptherapy (photopheresis). J Am Acad Dermatol. 1999 Dec;41(6):915-22.
- Rostami AM, Sater RA, Bird SJ, et al. A double-blind, placebo-controlled trial of extracorporeal photopheresis in chronic progressive multiple sclerosis. Mult Scler. 1999 Jun;5(3):198-203.
- French LE, Lessin SR, Addya K, et al. Identification of clonal T cells in the blood of patients with systemic sclerosis: positive correlation with response to photopheresis. Arch Dermatol. 2001 Oct;137(10):1309-13.
- Greinix HT, Volc-Platzer B, Rabitsch W, et al. Successful use of extracorporeal photochemotherapy in the treatment of severe acute and chronic graft-versus-host disease. Blood. 1998 Nov 1;92(9):3090-104.
- Ontario Health Technology Advisory Committee Extracorporeal photopheresis. Updated March 26, 2006. Accessed April 29,2009. Available at this URL
- ECRI. Extracorporeal Photopheresis for Transplant Rejection. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2007 January 10. 5 p. (ECRI Hotline Response). Also available: http://www.ecri.org.
- ECRI. Applications of Extracorporeal Photopheresis. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 April 10. 11 p. (ECRI Hotline Response). Also available: http://www.ecri.org.
- Marques MB, Tuncer HH. Photopheresis in solid organ transplant refection. J Clin Apher 2006; 21(1):72-7.
- 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):106-75.
- Maccherini M, Diciolla F, Laghi Pasini F et al. Photopheresis immunomodulation after heart transplantation. Transplant Proc 2001; 33(1-2):1591-4.
- Benden C, Speich R, Hofbauer GF et al. Extracorporeal photopheresis after lung transplantation: a 10-year single-center experience. Transplantation 2008; 86(11):1625-7.
- Urbani L, Mazzoni A, Catalano G et al. The use of extracorporeal photopheresis for allograft rejection in liver transplant recipients. Transplant Proc 2004; 36(10):3068-70.
- Jardine MJ, Bhandari S, Wyburn KR et al. Photopheresis therapy for problematic renal allograft rejection. J Clin Apher 2009; 24(4):161-9.
- Whittle R, Taylor PC. Circulating B-cell activating factor level predicts clinical response of chronic graft-versus-host disease to extracorporeal photopheresis. Blood. 2011 Oct 20. [Epub ahead of print].
- Kusztal M, Koscielska-Kasprzak K, Gdowska W et al. Extracorporeal photopheresis as an anti-rejection prophylaxis in kidney transplant recipients: preliminary results. Transpl Proc. 2011 Oct; 43(8):2938-40.
- Dignan FL, Greenblatt D, Cox M et al. Efficacy of bimonthly extracorporeal photopheresis in refractory chronic mucocutaneous GVHD. Bone Marrow Transplant. 2011 Sep 19. doi: 10.1038/bmt.2011.186. [Epub ahead of print].
- Rapheal BA, Shin DB, Suchin KR et al. High clinical response rate of Sézary syndrome to immunomodulatory therapies: prognostic markers of response. Arch Dermatol. 2011 Aug 15. [Epub ahead of print].
- Marques MB, Schwartz J. Update on extracorporeal photopheresis in heart and lung transplantation. J Clin Apher. 2011; 26(3):146-51. Doi: 10.1002/jca.20274. Epub 2010 Dec 6.
- Greinix HT, van Besien K, Elmaagacli AH et al. Progressive improvement in cutaneous and extracutaneous chronic graft-versus-host disease after a 24-week course of extracorporeal photopheresis-results of a crossover randomized study. Biol Blood Marrow Transplant. 2011 May 11. [Epub haead of print].
- Talpur R, Demierre MF, Geskin L et al. Multicenter photopheresis intervention trial in early-stage mycosis fungoides. Clin Lymphoma Myeloma Leuk. 2011 Apr; 11(2):219-27. Epub 2011 Apr 8.
- Gonzalez VM, Ramirez M Sevilla J et al. Analysis of clinical outcome and survival in pediatric patients undergoing extracorporeal photopheresis for the treatment of steroid-refractory GVHD. J Pediatr Hematol Oncol. 2010 Nov;32(8):589-93.
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Policy History:
Date Reason Action
September 2010 Annual review Policy revised
November 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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