Nationally Non-Covered Indications

I. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Effective for claims with dates of service on or after May 24, 1996, through January 26, 2016, allogeneic HSCT is not covered as treatment for multiple myeloma. Refer to Pub. 100-03, NCD Manual, chapter 1, section 110.23, for further information about this policy, and Pub. 100-04, chapter 32, section 90, for information on coding.

II. Autologous Stem Cell Transplantation (AuSCT)

Insufficient data exist to establish definite conclusions regarding the efficacy of AuSCT for the following conditions:

a) Acute leukemia not in remission; 

b) Chronic granulocytic leukemia; 

c) Solid tumors (other than neuroblastoma); 

d) Up to October 1, 2000, multiple myeloma; 

e) Tandem transplantation (multiple rounds of AuSCT) for patients with multiple myeloma;

f) Effective October 1, 2000, non primary AL amyloidosis; and, 

g) Effective October 1, 2000, through March 14, 2005, primary AL amyloidosis for Medicare beneficiaries age 64 or older

In these cases, AuSCT is not considered reasonable and necessary within the meaning of §l862(a)(1)(A) of the Act and is not covered under Medicare. 

D. Other

All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.

Billing for Stem Cell Transplantation

A. - Billing for Allogeneic Stem Cell Transplants 

1. Definition of Acquisition Charges for Allogeneic Stem Cell Transplants

Acquisition charges for allogeneic stem cell transplants include, but are not limited to, charges for the costs of the following services:

 National Marrow Donor Program fees, if applicable, for stem cells from an unrelated donor; 

 Tissue typing of donor and recipient; 

 Donor evaluation;  Physician pre-admission/pre-procedure donor evaluation services; 

 Costs associated with harvesting procedure (e.g., general routine and special care services, procedure/operating room and other ancillary services, apheresis services, etc.); 

 Post-operative/post-procedure evaluation of donor; and 

 Preparation and processing of stem cells.