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National Coverage Analysis (NCA) Tracking Sheet for Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (CAG-00011N)

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AuSCT is a process used to treat various malignancies in which stem cells are harvested from a patient's bone marrow or peripheral blood, stored, and then given back to the patient following severely myelotoxic doses of chemotherapy and/or radiotherapy. Section 35-30.1 of the Coverage Issues Manual (CIM) states that AuSCT is a non-covered condition in the treatment for multiple myeloma (MM). This decision was based on the insufficiency of data to establish efficacy. The Health Care Financing Administration (HCFA) must evaluate whether new scientific data on AuSCT supports reconsideration for national coverage in the MM population.
Inpatient Hospital Services
Physicians' Services
Requestor Name(s):  HCFA Internally Generated Request
Formal Request Accepted and Review Initiated:  06/29/1999
Expected NCA Completion Date:  06/05/2000
Public Comment Period:  07/29/1999 - 08/29/1999
Decision Memo Released:  05/31/2000
Lead Analyst(s): 
  • Jackie Sheridan-Moore
September 15-16, 1999 The first meeting of the Medicare Coverage Advisory Committee's (MCAC) Drugs, Biologics and Therapeutics (DBT) panel  was held on the topic of AuSCT for MM. At the conclusion of the meeting, the panel recommended that sufficient evidence existed to support the treatment of MM in the Medicare population. A summary of the meeting was completed by the panel's Executive Secretary and was approved by the panel chair.
December 8, 1999 The MCAC Executive Committee (EC) reviewed the DBT's panel recommendations on AuSCT for MM and did not ratify them. Instead, the EC requested the issue be sent back to the DBT panel for reexamination. As part of their discussions, the EC identified a number of areas where the process could be improved, such as: clarifying the role of the MCAC, organization and presentation of evidence, and framing of issues or panel questions. A summary of the meeting was completed by the panel's Executive Secretary and was approved by the panel chair.
January 15, 2000 HCFA ordered a technology assessment on the use of AuSCT in patients with MM from Blue Cross and Blue Shield (BC/BS) Technology Evaluation Center (TEC).
April 5, 2000 BC/BS TEC technology assessment  completed and sent to HCFA for evaluation. HCFA has 60 days from receipt of the TEC report to review the assessment and issue its coverage decision. New due date will be June 5, 2000.
May 31, 2000 Decision complete. HCFA will remove non-coverage policy for AuSCT in MM and replace it with a limited coverage policy. See Decision Memorandum dated May 31, 2000.

In instances where HCFA issues a decision and payment changes need to be made to implement the policy, claims processing instructions must be written and officially transmitted to our Medicare contractors in order to allow for proper billing and payment of claims for this procedure. According to our coverage process, HCFA has up to 180 days from the next full calendar quarter (which starts on July 1, 2000) to implement any payment changes. Once instructions have been released to the contractors, HCFA will post the effective date of this revised policy. Services provided to beneficiaries on or after that date would be eligible for payment. HCFA will be unable to retroactively reimburse claims prior to the anticipated implementation date.
August 29, 2000 Payment instructions released to the Medicare contractors. The national coverage decision for AuSCT in MM will be effective starting October 1, 2000. Services provided to qualified beneficiaries on or after October 1, 2000 will be eligible for payment. HCFA will be unable to retroactively reimburse claims prior to October 1, 2000.
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