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Stem Cell Transplantation
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MLN Matters. . .Information for Medicare Providers
(Issued by the Centers for Medicare & Medicaid Services)
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Provider Types Affected
Physicians, suppliers, and providers billing Medicare carriers and/or fiscal intermediaries (FIs) for services related to stem cell transplantation
Provider Action Needed Impact to You This article is based on Change Request (CR) 4173, which includes clarifying language specific to the current national coverage policy on stem cell transplantation.
What You Need to Know CR4173 clarifies that stem cell transplantation and high-dose chemotherapy are both integral to the course of treatment and are covered as a single entity.
What You Need to Do See the Background section of this article for further details regarding this change.
Background The Centers for Medicare & Medicaid Services (CMS) has a coverage policy for stem cell transplantation, and the Medicare National Coverage Determination (NCD) Manual (Pub. 100-03, Section 110.8) 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. Autologous stem cell transplants (AuSCT) must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (High Dose Chemotherapy (HDCT)) and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplantation is a procedure in which a portion of a healthy donor’s stem cell or bone marrow is obtained and prepared for intravenous infusion and may also be used to restore function.
CR4173 clarifies existing NCD policy language and corresponding claims processing language as follows:
“Bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage. When bone marrow or peripheral blood stem cell transplantation is noncovered, none of the steps are covered.” Note: There is no change to existing CMS coverage policy or claims processing instructions.
Implementation The implementation date for this instruction is January 3, 2006, and will be effective for dates of service on or after December 28, 2005.
Additional Information
For complete details, please see the official instruction issued to your carrier/intermediary regarding this change. Those instructions are in two parts. The first part is the actual change to the Medicare National Coverage Determinations (NCD) Manual, which includes the actual policy language regarding stem cell transplantation. That part may be viewed at http://cms.hhs.gov/transmittals/downloads/R45NCD.pdf on the CMS Web site. The second part contains the changes to the Medicare Claims Processing Manual. Those changes are available at http://cms.hhs.gov/transmittals/downloads/R766CP.pdf on the CMS Web site.
If you have questions, please contact your carrier or FI at their toll-free number, which may be found at http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf on the CMS Web site.
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.
For more information, visit the Medlearn Matters Web page at: http://www.cms.hhs.gov/MedlearnMattersArticles. 
Pub. 100-4, Transmittal# 766, CR# 4173
Pub. 100-3, Transmittal# 43, CR# 4173
Medlearn Matters Number: MM 4173
Related CR Release Date: December 2, 2005
Effective Date: December 28, 2005
Implementation Date: January 3, 2006
Posted: 12/29/2005
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