National Coverage Analysis (NCA) Tracking Sheet

Extracorporeal Photopheresis (ECP)

CAG-00324R2

Issue

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administration) but the drug can alternatively be administered directly to the patient before the white blood cells are withdrawn.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.

National Coverage Determinations

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Ramsey R. Hachem, MD View Letter
George J. Despotis, MD N/A
Keith E. Berman, MPH, MBA N/A
N/A

Important Dates

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 Due Date
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

Contacts

Lead Analysts
Kimberly Long
kimberly.long@cms.hhs.gov
410-786-5702
Lead Medical Officers
Jeffrey C. Roche, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

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/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

February 2, 2012

April 30, 2012