(TN 13) (CR 3265), 04/2005 - Covered for primary AL amyloidosis when amyloid deposition in 2 or fewer organs and cardiac left ventricular ejection fraction greater than 45%.

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. No policy-related changes are included with the ICD-10 quarterly updates.

Effective date 10/01/2000. Coding guidance remains in the Claims Processing Manual.

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. The NCD for Stem Cell Transplantation Multiple Myeloma (MM), Myelofibrosis (MF) and Sickle Cell Disease (SCD), released by CMS on January 27, 2016, concluded that, CMS will cover items and services necessary for research under §1862(a)(1)(E) for a allogeneic hematopoietic stem cell transplant (HSCT) for certain Medicare beneficiaries with multiple myeloma (MM) using the Coverage with Evidence Development (CED) paradigm. All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion. Data elements to be used in risk stratification models should include: Graft vs. host disease (acute and chronic); Graft vs. host disease (acute and chronic). CMS Approval Date: 06/05/2017, Allogeneic Hematopoietic Stem Cell Transplant for Multiple Myeloma, A federal government website managed and paid for by the U.S. Centers for Medicare & If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary. These NCD coding changes are the result

Instructions for enabling "JavaScript" can be found here. A prospective clinical study seeking Medicare coverage for allogeneic HSCT for myelofibrosis pursuant to Coverage with Evidence Development (CED) must address the following question: Compared to patients who do not receive allogeneic HSCT, do Medicare beneficiaries with MF who receive allogeneic HSCT transplantation have improved outcomes as indicated by: f)   Effective for claims with dates of service on or after January 27, 2016, allogeneic HSCT for sickle cell disease (SCD) is covered by Medicare only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical study. Advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched donor. b)   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. MDS refers to a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells. Effective Date: 01/27/2016 Implementation Date: 10/03/2016. (TN 193) (CR9620), 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). Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate.

(TN 2005) (CR10318), 09/2009 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs.

Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. Autologous stem cell transplantation (AuSCT) is a technique for restoring stem cells using the patient's own previously stored cells. 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. 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. A prospective clinical study seeking Medicare coverage of allogeneic HSCT for multiple myeloma pursuant to CED must address the following question: Prospectively, compared to patients who do not receive allogeneic HSCT, do Medicare beneficiaries with multiple myeloma who receive allogeneic HSCT have improved outcomes as indicated by: Instructions on how to submit an application for CMS approval of study protocols can be found on Appendix C of the Final Decision Memo. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. (TN 84), 08/2000 - Covered for patients with multiple myeloma.

"JavaScript" disabled. These updates do not expand, restrict, or alter existing coverage policy. 100-03, chapter 1, section 110.23, of the NCD Manual, for further information. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. If you receive Stem Cell Therapy in outpatient settings, this will fall under Part B. Expedited Process to Remove National Coverage Determinations, Potential National Coverage Determination (NCD) Topics, Contacts for Part A - Medicare Administrative Contractor (MAC - Part A), Contacts for Part A & B - Medicare Administrative Contractor (A & B MAC), Contacts for Part A & B & Home Health & Hospice- Medicare Administrative Contractor (A & B & HHH MAC), Contacts for Part B - Medicare Administrative Contractor (MAC - Part B), Contacts for Durable Medical Equipment Medicare Administrative Contractor (DME MAC), https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, Original consideration for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (CAG-00415N), First reconsideration for Autologous Stem Cell Transplantation (AuSCT) for Amyloidosis (CAG-00050R), Original consideration for Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (CAG-00011N), First reconsideration for Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (CAG-00011R), Original consideration for Autologous Stem Cell Transplantation for AL Amyloidosis (CAG-00050N), First reconsideration for Stem Cell Transplantation (CAG-00287R), First reconsideration for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease) (CAG-00444R), Original consideration for Stem Cell Transplantation (Removal of Coding Information from NCD) (CAG-00193N).

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 … 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. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. 7500 Security Boulevard, Baltimore, MD 21244, National Coverage Determination (NCD) for Stem Cell Transplantation (Formerly 110.8.1) (110.23). The following are existing associations with NCAs, from the National All forms of non-primary AL amyloidosis remain non-covered. The CMS.gov Web site currently does not fully support browsers with

The clinical research study is registered on the, The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. This NCD has been or is currently being reviewed under the National Coverage The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Determination process. The research study is sponsored by an organization or individual capable of executing the proposed study successfully. Medicare may help cover bone marrow transplant and treatment for the following: Aplastic anemia, leukemia, or leukemia that is in remission. All Medicare approved studies must use appropriate statistical techniques in the analysis to control for selection bias and potential confounding by age, duration of diagnosis, disease classification, DIPSSplus score, comorbid conditions, type of preparative/conditioning regimen, graft vs. host disease (GVHD) prophylaxis, donor type and cell source. Part B covers 80% of the cost, you’re responsible for 20% of the cost. (TN 1975) (CR10318), 01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10)

Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.

The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. If a study is regulated by the Food and Drug Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with 05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). (TN 2427) (CR11491). Risk stratification methods should be used to control for selection bias.

Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R193NCD.pdf, Revision History of 110.8.1 (see NCD110.23, CR9620, effective 1/27/16), 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. How Much Does Stem Cell Therapy Cost with Medicare? These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Sign up to get the latest information about your choice of CMS topics in your inbox. Sponsor: Center for International Blood and Marrow Transplant Research (TN 1388)(CR 8691), Revision History of 110.23 (formerly NCD110.8.1 prior to 1/27/16, see 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. If you receive Stem Cell Therapy in inpatient settings, this will fall under Part A.