National Coverage Analysis (NCA) Tracking Sheet

Autologous Stem Cell Transplantation (AuSCT) for Amyloidosis



Autologous stem cell transplantation (AuSCT) is a process in which stem cells are harvested from a patient’s bone marrow or peripheral blood, stored, and then transplanted back into the patient following high dose chemotherapy used to treat various malignancies.

Currently section 110.8.1 of the National Coverage Determination (NCD) manual (CIM §35-30) states that this procedure is covered via contractor discretion for patients 63 years of age and under. As of October 1, 2000, primary AL amyloidosis has a national non-coverage determination for Medicare beneficiaries 64 years of age or older.

At the conclusion of the initial coverage determination CMS agreed to reconsider this coverage determination if new evidence became available. The requestors have submitted new data relating to this transplant procedure that was not available at the time of the original determination.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Legacy Good Samaritan Hospital & Medical Center View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
06/15/2004 - 07/15/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
12/15/2004 - 01/14/2005
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Susan Harrison
Samantha Richardson
Lead Medical Officers
Lori Paserchia, MD

Medicare Benefit Category Determination Date

Actions Taken

June 15, 2004

Reviewed and accepted reconsideration request.

July 26, 2004

Comments [PDF, 15KB] from the 30-day public comment period are now available for viewing.

December 15, 2004

CMS is posting a Proposed Decision Memorandum for a 30-day public comment period. CMS is particularly interested in comments on the following:

  • CMS interpretation of the evidence and
  • CMS decision.

    CMS is requesting public comments on this proposed decision memorandum pursuant to Section 731 of the Medicare Modernization Act. 

    Instructions for submitting public comments are available at After considering the public comments, we will issue a final decision memorandum.
  • March 15, 2005