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National Coverage Analysis (NCA) Tracking Sheet for Autologous Stem Cell Transplantation (AuSCT) for Amyloidosis (CAG-00050R)

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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.
Inpatient Hospital Services
Physicians' Services
Requestor Name(s):  Legacy Good Samaritan Hospital & Medical Center
Requestor Letter(s):  View Letter
Formal Request Accepted and Review Initiated:  06/15/2004
Expected NCA Completion Date:  03/11/2005
Public Comment Period:  06/15/2004 - 07/15/2004
Proposed Decision Memo Released:  12/15/2004
Proposed Decision Memo Public Comment Period: 12/15/2004 - 01/14/2005 
Decision Memo Released:  03/15/2005
Comments for this NCA::  View Public Comments
Lead Analyst(s): 
  • Susan Harrison
  • Samantha Richardson
Lead Medical Officer(s): 
  • Lori Paserchia, MD
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 http://www.cms.hhs.gov/coverage/8h.asp.

After considering the public comments, we will issue a final decision memorandum.
March 15, 2005 Posted Final Decision Memo.
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