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National Coverage Analysis (NCA) Tracking Sheet for Extracorporeal Photopheresis (ECP) (CAG-00324R2)

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Extracorporeal photopheresis is a medical procedure in which a patient's white blood cells are exposed first to a drug called 8-methoxypsoralen (8-MOP) and then to ultraviolet A (UVA) light. The procedure starts with the removal of the patient's blood, which is centrifuged to isolate the white blood cells. The drug is typically administered directly to the white blood cells after they have been removed from the patient (referred to as ex vivo administration) but the drug can alternatively be administered directly to the patient before the white blood cells are withdrawn. After UVA light exposure, the treated white blood cells are then re-infused into the patient.

Extracorporeal photopheresis is covered by Medicare for the following disorders:

  • Palliative treatment of skin manifestations of CTCL that has not responded to other therapy.
  • Patients with acute cardiac allograft rejection refractory to standard immunosuppressive drug treatment; and
  • Patients with chronic graft versus host disease refractory to standard immunosuppressive drug treatment.

All other applications of ECP remain nationally non-covered. (NCD Manual Section 110.4)

The Centers for Medicare & Medicaid Services (CMS) received a formal written request for reconsideration to add coverage for ECP treatment for patients who have received lung allografts and then developed progressive bronchiolitis obliterans syndrome (BOS) refractory to immunosuppressive drug treatment.

Physicians' Services
Requestor Name(s):  Ramsey R. Hachem, MD; George J. Despotis, MD; Keith E. Berman, MPH, MBA
Requestor Letter(s):  View Letter
Formal Request Accepted and Review Initiated:  08/04/2011
Expected NCA Completion Date:  05/02/2012
Public Comment Period:  08/04/2011 - 09/03/2011
Proposed Decision Memo Released:  02/02/2012
Proposed Decision Memo Public Comment Period: 02/02/2012 - 03/03/2012 
Decision Memo Released:  04/30/2012
Comments for this NCA::  View Public Comments
Lead Analyst(s): 
Lead Medical Officer(s): 
  • Jeffrey C. Roche, MD, MPH
August 4, 2011 CMS opens this national coverage determination reconsideration request to review the coverage of extracorporeal photopheresis. CMS is requesting public comment on whether there is adequate evidence, including clinical trials, for evaluating health outcomes of extracorporeal photopheresis for the requested indications in the Medicare population. After considering the public comments and reviewing relevant evidence, we will release a proposed decision memorandum. Instructions for submitting public comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage.
February 2, 2012 Posted proposed decision memo
April 30, 2012 Posted final decision memo.
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