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September 3, 2020
by Admin
A prospective clinical study seeking Medicare coverage for allogeneic HSCT for sickle cell disease 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 SCD who receive allogeneic HSCT have improved outcomes as indicated by: All CMS-approved clinical studies and registries must adhere to the below listed standards of scientific integrity and relevance to the Medicare population listed in section g: g) All CMS-approved clinical studies and registries in sections d, e and f must adhere to the below listed standards of scientific integrity and relevance to the Medicare population: Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions. 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 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. No policy-related changes are included with the ICD-10 quarterly updates. Newly diagnosed or responsive multiple myeloma. Prospectively, in Medicare beneficiaries with MDS who receive HSCT, what treatment facility characteristics predict meaningful clinical improvement in the following outcomes: In addition, the clinical study must adhere to the following standards of scientific integrity and relevance to the Medicare population: Consistent with section 1142 of the Social Security Act, the Agency for Health Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions. The study is sponsored by an organization or individual capable of completing it successfully. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. While … The clinical research studies and registries are registered on the, The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. Medicare covers two types of stem cell transplants: allogeneic hematopoietic stem cell transplantation (HSCT) and autologous stem cell transplantation (AuSCT). It should be a prospective, longitudinal study with clinical information from the period before HSCT and short- and long-term follow-up information. Implementation date: 10/07/2013 Effective date: 10/1/2015. 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. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see. The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. There must be appropriate statistical techniques to control for selection bias and confounding by age, duration of diagnosis, disease classification, International Myeloma Working Group (IMWG) classification, ISS stage, comorbid conditions, type of preparative/conditioning regimen, graft vs. host disease (GVHD) prophylaxis, donor type and cell source. 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. No policy-related changes are included with the ICD-10 quarterly updates. All aspects of the study are conducted according to appropriate standards of scientific integrity. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. Determination process. Allogeneic HSCT for multiple myeloma will be covered by Medicare only for beneficiaries with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma who are participating in an approved prospective clinical study that meets the criteria below. The research study does not unjustifiably duplicate existing studies. The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use. 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