National Coverage Analysis (NCA) Tracking Sheet

Extracorporeal Photopheresis

CAG-00324R

Issue

Extracorporeal photopheresis is a second-line treatment for a variety of oncological and autoimmune disorders, including patients with cutaneous T-cell lymphoma (CTCL) that is resistant to chemotherapy and radiotherapy. The treatment protocols may differ, but initially begins with the oral administration of an oral drug methoxsalen. The patient's blood is then passed through a device that permits exposure of the blood, while it is outside the body (extracorporeal), to ultraviolet A light. The blood is then returned to the patient.  Extracorporeal photopheresis is covered by Medicare only when used in the palliative treatment of the skin manifestations of CTCL that has not responded to other therapy. (National Coverage Determination (NCD) Manual section 110.4).

On March 21, 2006, CMS received a formal request for reconsideration from the University of Pennsylvania Health System. The University requests that CMS update its NCD by allowing for the additional indications for photopheresis in treating the following specific disorders

  • acute cardiac transplant rejection,
  • chronic graft versus host disease,
  • pemphigus vulgaris, and
  • bullous pemphigoid refractory to conventional immunosuppressive therapy.

In addition they request expanded Medicare contractor discretion for the treatment of CTCL.

National Coverage Determinations

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
University of Pennsylvania Health System View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/06/2006
Expected NCA Completion Date
01/02/2007
Public Comment Period
04/06/2006 - 05/06/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
10/04/2006
Proposed Decision Memo Public Comment Period
10/04/2006 - 11/03/2006
Decision Memo Released
12/19/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Susan Harrison
Sandra Jones, RN
Lead Medical Officers
Lori Paserchia, MD

Medicare Benefit Category Determination Date

Actions Taken

April 6, 2006

CMS opens this national coverage determination 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.

October 4, 2006

CMS posts a proposed decision memorandum to modify section 110.4 of the Medicare NCD manual.

At this time CMS is requesting public comments on the proposed decision memorandum. CMS is particularly interested in the quality of data and evidence cited in public comments rather than the quantity of comments received. To submit a public comment please click on the orange "comment" button located at the top of this page and type or cut and paste your comment in the text box that appears. Comments of any length may be entered in this box. For more information about submitting public comments please visit http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

After the 30-day public comment period closes, CMS will review submitted comments and issue a final decision within 60 days.

November 21, 2006

December 19, 2006

CMS posts a final decision memorandum to modify section 110.4 of the Medicare NCD Manual.