Stem Cell Transplantation (Formerly 110.8.1)

A. General

Stem cell transplantation is a process in which stem cells are harvested from either a patient’s (autologous) or donor’s (allogeneic) bone marrow or peripheral blood for intravenous infusion. Autologous stem cell transplantation (AuSCT) is a technique for restoring stem cells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic hematopoietic stem cell transplantation (HSCT) is a procedure in which a portion of a healthy donor's stem cell or bone marrow is obtained and prepared for intravenous infusion. Allogeneic HSCT may be used to restore function in recipients having an inherited or acquired deficiency or defect. Hematopoietic stem cells are multi-potent stem cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis - a process by which cells that are unneeded or detrimental will self-destruct.

The Centers for Medicare & Medicaid Services (CMS) is clarifying that 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 non-covered, none of the steps are covered.

B. Nationally Covered Indications

I. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

1. Effective for services performed on or after August 1, 1978, for the treatment of leukemia, leukemia in remission, or aplastic anemia when it is reasonable and necessary,
2. Effective for services performed on or after June 3, 1985, for the treatment of severe combined immunodeficiency disease (SCID) and for the treatment of Wiskott-Aldrich syndrome, and
3. Effective for services performed on or after March 6, 2024, allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood or umbilical cord blood stem cell products for Medicare patients with myelodysplastic syndromes who have prognostic risk scores of:


• ≥ 1.5 (Intermediate-2 or high) using the International Prognostic Scoring System (IPSS), or
• ≥ 4.5 (high or very high) using the International Prognostic Scoring System - Revised (IPSS-R), or
• ≥ 0.5 (high or very high) using the Molecular International Prognostic Scoring System (IPSS-M).

MDS refers to a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells. These disorders are varied with regard to clinical characteristics, cytologic and pathologic features, and cytogenetics. The abnormal production of blood cells in the bone marrow leads to low blood cell counts, referred to as cytopenias, which are a hallmark feature of MDS along with a dysplastic and hypercellular-appearing bone marrow.

II. Autologous Stem Cell Transplantation (AuSCT)

1. Effective for services performed on or after April 28, 1989, AuSCT is considered reasonable and necessary under §l862(a)(1)(A) of the Act for the following conditions and is covered under Medicare for patients with:
   
   1. Acute leukemia in remission who have a high probability of relapse and who have no human leucocyte antigens (HLA)-matched;
   2. Resistant non-Hodgkin's lymphomas or those presenting with poor prognostic features following an initial response;
   3. Recurrent or refractory neuroblastoma; or,
   4. Advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched donor.
   
   
2. Effective October 1, 2000, single AuSCT is only covered for Durie-Salmon Stage II or III patients that fit the following requirements:
   
   • Newly diagnosed or responsive multiple myeloma. This includes those patients with previously untreated disease, those with at least a partial response to prior chemotherapy (defined as a 50% decrease either in measurable paraprotein [serum and/or urine] or in bone marrow infiltration, sustained for at least 1 month), and those in responsive relapse; and
   • Adequate cardiac, renal, pulmonary, and hepatic function.
   
   
3. Effective for services performed on or after March 15, 2005, when recognized clinical risk factors are employed to select patients for transplantation, high dose melphalan (HDM) together with AuSCT is reasonable and necessary for Medicare beneficiaries of any age group with primary amyloid light chain (AL) amyloidosis who meet the following criteria:
   • Amyloid deposition in 2 or fewer organs; and,
   • Cardiac left ventricular ejection fraction (EF) greater than 45%.

C. 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.

II. Autologous Stem Cell Transplantation (AuSCT)

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

1. Acute leukemia not in remission;
2. Chronic granulocytic leukemia;
3. Solid tumors (other than neuroblastoma);
4. Up to October 1, 2000, multiple myeloma;
5. Tandem transplantation (multiple rounds of AuSCT) for patients with multiple myeloma;
6. Effective October 1, 2000, non-primary AL amyloidosis; and,
7. 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

Coverage of all other indications for stem cell transplantation not otherwise specified above as covered or non-covered will be made by local Medicare Administrative Contractors under section 1862(a)(1)(A).

CED page - Allogeneic Hematopoietic Stem Cell Transplant for MDS

CED page - Allogeneic Hematopoietic Stem Cell Transplant for Multiple Myeloma

CED page - Allogeneic Hematopoietic Stem Cell Transplant for Myelofibrosis

CED page - Allogeneic Hematopoietic Stem Cell Transplant for Sickle Cell Disease

05/2024 - The purpose of this Change Request (CR) is to inform contractors that CMS is expanding Medicare coverage for allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood or umbilical cord blood stem cell products for Medicare patients with MDS who meet specific criteria. (TN 12627) (CR13604)

02/2024 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 12493) (CR13507)

Revision History of 110.8.1 (see NCD110.23, CR9620, effective 1/27/16)

10/2022 - Transmittal 11546, dated August 4, 2022, is being rescinded and replaced by Transmittal 11636, dated, October 5, 2022, to remove ICD-10 dx codes added in error to NCD 150.3, business requirement 12842.4, and restore ICD-10 dx C91.92 removed in error to NCD 110.23, business requirement 12842.3. All other information remains the same. (TN 11636) (CR12842)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 11546) (CR12842)

06/2022 - Transmittal 10832, dated June 2, 2021, is being rescinded and replaced by Transmittal 11453, dated, June 10, 2022, to revise NCD 90.2, NGS, revises business requirement 12124.2 and 12124.2.1 and its associated spreadsheet of coding by retainining all ICD-10 NOC diagnosis codes proposed for deletion effective July 1, 2022. (TN 11453) (CR12124)

01/2022 - Transmittal 11068, dated October 21, 2021, is being rescinded and replaced by Transmittal 11179, dated, January 12, 2022 to revise the attachment for NCD 110.24, CAR-T, to add business requirement 12480.10.1 by adding generic unspecified procedure codes, to clarify coverage and claims processing in the policy section and to review the implementation date. All other information remains the same. (TN 11179) (CR12480)

10/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11068) (CR12480)

09/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11025) (CR12399)

08/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10963) (CR12399)

06/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10832) (CR12124)

05/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10804) (CR12124)

03/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10624) (CR12124)

01/2021 - Transmittal 10515, dated December 10, 2020, is being rescinded and replaced by Transmittal 10566, dated, January 14, 2021 to remove FISS Reason Codes (RCs) 59041, 59042, 59209, and 59210 from the spreadsheet for NCD 160.18. All other information remains the same. (TN 10566) (CR12027)

12/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10515) (CR12027)

10/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10432) (CR12027)

02/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2427) (CR11491)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2005) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 1975) (CR10318)

05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1854) (CR10086)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1792) (CR9861)

07/2016 - Transmittal 191 dated April 29, 2016, is being rescinded and replaced by Transmittal 193, dated July 1, 2016 to provide clarifying language for references to the Pub. 100-03 NCD manual, under Summary of Changes. All other information remains the same. (TN 193) (CR9620)

04/2016 - Effective for claims with dates of service on and after January 27, 2016, contractors shall be aware that the use of allogeneic HSCT for treatment of Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease is only covered by Medicare if provided in the context of a Medicare-approved clinical study meeting specific criteria under the CED paradigm.This CR also clarifies the ICD-9 and ICD-10 diagnosis codes for allogeneic HSCT for treatment of Myelodysplastic Syndromes in the context of a Medicare-approved, prospective clinical study under the CED paradigm.See Pub. 100-03, chapter 1, section 110.23, of the NCD Manual, for further information. Effective Date: 01/27/2016 Implementation Date: 10/03/2016. (TN 191) (CR9620)

Revision History of 110.23 (formerly NCD110.8.1 prior to 1/27/16, see CR9620)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388)(CR 8691)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2015. (TN 1199) (CR 8197)

10/2010 - Effective for claims with dates of service on and after August 4, 2010, contractors shall be aware that the use of allogeneic HSCT for treatment of MDS is only covered by Medicare if provided in the context of a Medicare-approved clinical study meeting specific criteria under the CED paradigm. Effective date 08/04/2010 Implementation date 11/10/2010 (TN 127) (CR 7137)

09/2009 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 2362) (CR11392)

12/2005 - CMS clarified that 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 non-covered, none of the steps are covered. Effective date 11/28/2005. Implementation date 01/03/2006. (TN 45) (CR 4173)

04/2005 - Covered for primary AL amyloidosis when amyloid deposition in 2 or fewer organs and cardiac left ventricular ejection fraction greater than 45%. All forms of non-primary AL amyloidosis remain non-covered. Effective date 3/15/2005. Implementation date 5/16/2005. (TN 32) (CR 3797)

05/2004 - Removed coding guidance. Coding guidance remains in the Claims Processing Manual. Effective date 7/01/2004. Implementation date 7/06/2004. (TN 13) (CR 3265)

04/2003 - Removed reference to age as limitation on coverage of stem cell transplantation for patients with multiple myeloma. Effective date 10/01/2000. Implementation date 5/9/2003. (TN 169) (CR 2604)

11/2000 - Removed age limitation for coverage of autologous stem cell transplantation for patients with multiple myeloma. Effective date 10/1/2000. (PM AB-00-104) (CR 1375)

08/2000 - Covered for patients with multiple myeloma. Effective and implementation dates 10/01/2000. (TN 125) (CR 1002)

04/1996 - Clarified that policy for bone marrow transplants applies to all types of stem cell transplants, and added multiple myeloma to conditions excluded from coverage. Effective date 05/24/1996. (TN 84)