National Coverage Analysis (NCA) Tracking Sheet

Stem Cell Transplantation

CAG-00287R

Issue

The early treatment of certain cancers and hematologic disorders focused on oral chemotherapy regimens, first with standard doses of drugs such as melphalan, prednisone, and colchicines, and later with multiple drug regimens.  However, certain conditions respond poorly to standard chemotherapy, and many patients do not benefit from this treatment.

The poor response rates experienced with only chemotherapy prompted the development of high dose chemotherapy with autologous stem cell transplant (AuSCT). This treatment strategy includes a number of stages over a period of weeks. The first stage is called mobilization where the patient is given a granulocyte colony-stimulating factor (G-CSF) or a granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the release of the stem cells from storage sites within the body.  Next, the stem cells are harvested via leukapheresis or bone marrow biopsy. The next stage is called conditioning where the patient is given a high dose of a chemotherapy agent or radiotherapy. In the final stage the harvested stem cells are administered along with supportive medical care.

Currently section 110.8.1 of the National Coverage Determination (NCD) manual (CIM §35-30.1) states that stem cell transplantation is a “process in which stem cells are harvested from either a patient’s or donor’s bone marrow or peripheral blood for intravenous infusion. The transplant can be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplant may also be used to restore function.”

Recent events have raised concerns that there is a risk of misinterpretation of the NCD language.  We believe that it may not be clear that the stem cell transplant and the high dose chemotherapy are both integral to the course of treatment and covered as a single entity. Therefore, CMS is opening an NCD to clarify the definition of stem cell transplantation.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Internally generated N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/20/2005
Expected NCA Completion Date
11/29/2005
Public Comment Period
04/20/2005 - 05/20/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/30/2005
Proposed Decision Memo Public Comment Period
08/30/2005 - 09/30/2005
Decision Memo Released
11/28/2005
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Susan Harrison
Lead Medical Officers
Lori Paserchia, MD

Medicare Benefit Category Determination Date

Actions Taken

April 20, 2005

CMS opens this reconsideration for review of the definition of stem cell transplantation. CMS is requesting public comment before any corrections are made to §110.8.1. After considering the public comments, we will release a proposed decision memorandum.

August 30, 2005

CMS is requesting public comments on this proposed decision memo pursuant to Section 731 of the Medicare Modernization Act. After considering the public comments, we will release a final decision memorandum.

November 28, 2005