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CMS Studies – An Update CIBMTR Data Managers Meeting February 21, 2018
Sue Logan Clinical Research Coordinator CIBMTR Data Operations
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Conflict of interest There are no conflicts of interest to disclose
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Agenda What are CMS CED studies?
Current status of CIBMTR’s CMS CED studies Medicare reimbursement for CED studies
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Background
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What is CMS? Centers for Medicare & Medicaid Services (CMS) is a federal agency within the U.S. Department of Health and Human Services (HHS). Administers many programs including Medicare.
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Objective of all CMS studies
To provide a mechanism to Medicare beneficiaries for claims coverage for allogeneic HCT. To provide data requested by Medicare under its CED to make payment on claims for HCT using the existing research observational database of the CIBMTR
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What is CED? Coverage with Evidence Development (CED) is the means by which CMS can provide coverage and encourage clinical studies that will lead to solid evidence for future decision making. National Coverage Determination (NCD) Relatively rare mechanism used when: Safety has been assured Service has high potential of benefit Significant barriers to conduct of trials exist NCD = National Coverage Determinations A national coverage determination (NCD) is a United States nationwide determination of whether Medicare will pay for an item or service.
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Why is CED needed? Transplants in the older population continues to increase for a variety of diseases BMT community continued to work with CMS to consider other CED/NCD Decisions have been made for: MDS (Active Dec 2010) Myelofibrosis (Active Nov 2016) Multiple Myeloma (Active July 2017) Sickle Cell (Active Oct 2017)
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Requirements Centers must designate willingness to participate in CRF submission for CED A separate participation agreement is required for each study Participating recipients must sign CMS consent form
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CMS Consent CMS consent form – Feb 2017
Patients should be invited to participate in both the CMS CED study and the Research Database protocol. Patient participation in the CMS CED study is not dependent on their participation in the Research Database Protocol. An amendment to the CIBMTR protocol for the Research Database was approved by the NMDP IRB on February 8, An additional consent form titled, Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage, was also approved. This consent form will be used when enrolling patients on observational studies that fulfill Medicare & Medicaid Services (CMS) requirements for hematopoietic cell transplantation (HCT) indications under Coverage with Evidence Development (CED). Those four Medicare (CMS) studies are studies that use data from the Research Database, so they fall under the umbrella of the CIBMTR Research Database study. These studies use the existing research observational database of the CIBMTR to collect data requested by CMS as part of its payment policy. Patients enrolled on CIBMTR studies for indications under CED will sign a separate CMS consent form under the Research Database Protocol for participation in a CMS CED-approved study. These patients will be invited to participate in both the CMS CED study and the Research Database protocol. Patient participation in the CMS CED study is not dependent on their participation in the Research Database Protocol. Additional protocol or consent forms are not required for this study.
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CMS Consent ver 3.0 Revised consent form was approved by NMDP IRB Jan 2018. Language was added in Section IV regarding the NIH Certificate of Confidentiality. Language was added in Section IV regarding submitting health information to scientific databases. Language was added to inform participants of the protections and the limits to protection provided by a Certificate of Confidentiality issued by the National Institutes of Health (NIH). Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. Language was also added to inform participants that their health information may be placed into scientific databases that can be accessed by researchers outside the CIBMTR In the process of getting IRB approval of peds assent and parental permission forms> Centers will be notified when they are available
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Instructions for Transplant Centers That Use the NMDP/Be The Match IRB
Transplant centers that have an IRB Authorization Agreement with the NMDP IRB may begin using the new consent form immediately for enrolling patients on the CMS CED studies. No additional local review or approval is necessary.
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Instructions for Transplant Centers That Use Their Own Local IRB
If transplant centers use their own local IRB to enroll patients on the CMS CED studies, they should submit the revised protocol and new consent form to their IRB as soon as possible. It may be submitted as an amendment so they don’t have to wait until their local IRB continuing review
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Instructions for Transplant Centers That Use Their Own Local IRB
Centers are allowed to continue using their current consent form while they are obtaining IRB approval of the revised form. Renewals must be approved before their local IRB expiration date How long do centers have to get IRB approval? We don’t have a deadline for initial approval. If you anticipate enrolling patients, you should submit it as an amendment instead of waiting for your IRB’s annual continuing review. When the CMS consent form first came out, we told centers that, if they anticipated enrolling patients to a CMS study, they should get the new consent form approved by their IRB as an amendment (i.e., not wait until their local IRB annual continuing review), but we never gave them a hard and fast deadline Renewals have to be approved before the local IRB expiration date so that there’s not a lapse.
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Instructions for Transplant Centers That Use Their Own Local IRB
Once IRB approval is received, the IRB approval letter and IRB-approved consent form must be sent to Sue Logan at
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Reporting Requirements for all CMS CED studies
CRID assignment form 2804/2814 Enrollment form 2554 The paper 2517 form for the MDS study was retired in Feb You should now use the F2554 to enroll patients in any of the CMS studies. The F2554 is an on-demand form to be completed directly in FormsNet. The icon to generate it is located is on the left side of the screen, about a half inch below “Recipient Information”
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Reporting Requirements for all CMS CED studies
Pre-TED form 2400 Indicate CMS clinical trial 16-CMS-MF Comprehensive report forms - necessary for study objectives. If the patient is participating in another trial in addition the the CMS study, create another instance so both can be reported. You do not have to answer Q10 Subject ID. FormsNet will allow you to leave it blank. For all of the CMS studies, the patient’s CRID is their subject ID. They’re not assigned a separate ID for the study.
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Assessment of Allogeneic Hematopoietic Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic Syndrome and Related disorders - Part I. (10-CMSMDS) NCT
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10-CMSMDS Primary Objective: Secondary Objectives:
To prospectively examine outcomes of allogeneic HCT in adults >= 65 years of age with MDS to determine whether their outcomes are similar to those in younger patients. Secondary Objectives: To prospectively determine whether there are disease- or patient-related factors that predict outcomes of HCT for MDS and related disorders in patients >= 65 years of age To prospectively evaluate what transplant characteristics are associated with outcomes of HCT for MDS and related disorders in patients >= 65 years of age
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10-CMSMDS CMS decision in Summer of 2010
Opened for enrollment in December 2010 134 participating centers Current Enrollment 3466 >= 65 y/o Arm = 2181 <65 Arm = 1285
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10-CMSMDS Patients do not have to have Medicare to be enrolled in the study. 25% of patients with MDS who gave consent to the research database are enrolled 100% of patients over age 65 who gave consent to the research database are enrolled CMS consent and F2554 only required if CMS will be paying for the transplant The MDS study is different than the other CMS studies. The controls for the study are randomly chosen by FN from patients who consented to the RDB and meet the other enrollment criteria (pt age at transplant, MDS subtype). The 10-CMSMDS-1 study operates under the observational research protocol so if they consent to the research database and meet the other study criteria their data can be used for the study objectives. 100% of patients over age 65 who gave consent to the research database are enrolled, whether they have Medicare or not They only need to sign the CMS consent and complete the F2554 if they want Medicare to pay for the transplant.
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10-CMSMDS As of the January 30th, 2018 release of FormsNet3, centers will be required to complete Comprehensive Report Forms (CRF) for about half of the patients participating in the 10-CMSMDS-1 study. Further study information is located on the CIBMTR website at the following location: Half of all patients in the study will be randomized to TEDs. So an individual center may be a little higher or lower Recent revisions to the 2400, 2402, and 2450 forms enables CIBMTR to address relevant scientific questions using a mixture of TED and CRF data. This allows us to reduce the number of CRF forms we request. Further study information is located on the CIBMTR website at the following location
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BMT CTN 1102 Hypometh vs RIC for MDS
A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged with Intermediate-2 and High Risk Myelodysplastic Syndrome CTN 1102 is also a CMS CED study Co-enrollment in 10-CMSMDS and CTN 1102 is not allowed BMT CTN 1102 was approved by CMS as having met the requirements of the National Coverage Determination (NCD) for Stem Cell Transplantation. For additional information, visit the CMS Website approval posting located here: Both studies make the patient eligible for payment from Medicare under the CED mechanism. When a patient is already enrolled in CTN 1102 study, they aren’t eligible for the 10-CMSMDS study. If the pt is eligible for 1102, enroll them in that one instead of 10-CMSMDS. If the pt is not eligible or your center is not a CTN center, enroll them in 10-CMSMDS
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Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Myelofibrosis (16-CMS-MF) NCT
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16-CMS-MF HLA-Matched Donor HCT Study
Primary objective: Compare the five-year survival probabilities from DIPSS assessment between the two study arms: alloHCT recipients and non-HCT therapies (ruxolitinib / best supportive care) recipients. Secondary objectives: Compare leukemia-free survival at five years from DIPSS assessment. Identify patient-, disease-, and HCT-related factors associated with poor HCT outcomes in the alloHCT arm. Estimate the cumulative incidences of acute and chronic graft-versus-host disease, transplant related mortality, and relapse starting at HCT in the alloHCT arm. This observational study will compare outcomes of a prospectively-enrolled cohort of HCT recipients with outcomes of a cohort of age-matched historical non-HCT controls. Two co-primary analyses will be conducted, one for all alloHCT patients versus non-HCT and one for the subset of patients receiving MAC prior to alloHCT patients versus non-HCT. Data on the historical non-HCT controls will be collected at 14 US academic centers. These centers will provide data on all consecutive patients with PMF, post-ET MF, or post-PV MF referred to their institutions between 2000 and 2012.
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16-CMS-MF Haploidentical Donor Study
Primary objective: Estimate the five-year overall survival probabilities with haploidentical HCT from DIPSS assessment. Secondary objectives: Estimate five-year leukemia-free survival with haploidentical HCT from DIPSS assessment. Identify patient-, disease-, and HCT-related factors associated with poor outcomes post haploidentical HCT, starting at HCT. Estimate the cumulative incidences of acute and chronic GVHD, relapse, and transplant related mortality, starting at HCT. This is a descriptive prospective study of long-term outcomes of a cohort of MF patients that undergo haploidentical HCT
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16-CMS-MF CMS decision in October 2016 104 participating centers
Opened for enrollment in December 2016 Target Enrollment = 650 (225 MAC) Current Enrollment = 52 Non-HCT Arm = 2400 Target Enrollment = 650 (225 Myelablative conditioning) Potential enrolled is about double. 2554s submitted but the rest of the forms haven’t yet
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16-CMS-MF Eligibility Criteria
Primary myelofibrosis, post- essential thrombocythemia myelofibrosis, or post- polycythemia vera myelofibrosis. Int-2 or high-risk disease as determined by the DIPSS. Age ≥55 at the time of DIPSS. For the patients receiving an allogeneic transplant: 6/6 HLA-matched related donors 8/8 HLA-matched unrelated donor Haploidentical donor. 6/6 HLA-matched related donors Donors must be a 6/6 HLA-matched related donors Class I (HLA-A and -B) and Class II (HLA-DRBI) (but not monozygotic twins) OR 8/8 HLA-A, -B, -C, and -DRB1 Intermediate-2 (3 to 4 points) or high-risk (5 to 6 points) disease as determined by the DIPSS
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16-CMS-MF Eligibility Criteria
Both peripheral blood stem cells and bone marrow grafts are allowed. All conditioning regimen intensities are allowed All GVHD prophylaxis regimens are allowed Both peripheral blood stem cells and bone marrow grafts are allowed. CB not allowed o All conditioning regimen intensities are allowed. o All GVHD prophylaxis regimens are allowed.
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16-CMS-MF Ineligible if AlloHCT using umbilical cord blood unit(s)
HLA-mismatched adult donors (< 6/6 HLA alleles for related and < 8/8 HLA alleles for unrelated) Overlap syndromes (e.g., CMML, JMML) Prior allo HCT Patients with the following criteria will be ineligible for entry into the study: AlloHCT using umbilical cord blood unit(s) or HLA-mismatched adult donors (< 6/6 HLA alleles for related and < 8/8 HLA alleles for unrelated). . Overlap syndromes MDS/MPN overlap syndrome, basically meaning they have overlap condition with both dysplastic features of MDS and fibrosis of the myelofibrosis. (e.g., CMML, JMML)
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Secondary Myelofibrosis
If polycythemia vera or essential thrombocythemia develops myelofibrosis On the F2402 Select polycythemia vera or essential thrombocythemia in Q167 “MDS/MPN subtype at diagnosis” Q212 Did it transform to a different MDS/MPN subtype should be Yes Select primary myelofibrosis in Q213 “MDS/MPN subtype after transformation” Secondary Myelofibrosis isn’t an option on the 2402 form yet so we are instructing centers to report it under primary myelofibrosis when the pt had polycythemia vera or essential thrombocythemia prior to developing myelofibrosis.
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Dynamic International Prognostic Scoring System (DIPSS)
The Dynamic International Prognostic Scoring System (DIPSS) for primary myelofibrosis (PMF) uses five risk factors to predict survival: age older than 65 years hemoglobin lower than 10 g/dL leukocytes higher than 25 × 10(9)/L circulating blasts ≥ 1% constitutional symptoms weight loss, night sweats, fever Points are awarded for each risk factor Sum the points for each prognostic factor Prognostic variable 0 points 1 point 2 points Age (y) ≤ 65> 65 - White blood cell count (x109/L)≤ 25 > 25 - Hemoglobin (g/dL) ≥ 10 - < 10 Peripheral blood blasts (%) < 1 ≥ 1 - Constitutional symptoms? No Yes - 2. Determine DIPSS risk category and prognosis DIPSS score DIPSS risk category Median OS (y) 0 Low Not reached 1 – 2 Intermediate 3 – 4 Intermediate-2 4 5 – 6 High 1.5
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Additional Required Forms
F2555 CMS – MF Myelofibrosis Eligibility Form F2556 Myelofibrosis Supplemental Pre-HCT Data F2557 Myelofibrosis Supplemental Post-HCT Data F2556 & 2557 = disease specific information not on F2014 & 2114
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Why is my patient on the CRF track when they are not enrolled in the study?
Comprehensive report forms, including the 2556 and 2557, are now required for all patients with myelofibrosis transplanted after 2/1/2017 This includes non-Medicare patients and Medicare patients who are not eligible for the study. Centers that are not participating in the CMS study will be required to submit comprehensive report forms for their myelofibrosis patients. The only exception to this is when the patient declines consent for CIBMTR’s research database. Comprehensive report forms, including the 2556 and 2557, are now required for all patients with myelofibrosis transplanted after 2/1/2017, regardless of whether the patient is participating in the myelofibrosis study or not. So if 2400 completed before 2/1/17 can stay on TED. CIBMTR’s scientific directors made this decision last year because myelofibrosis is a rare disease. They decided to increase the number of patients on the CRF track to ensure our observational studies have enough power to give statistically valid results. We have the same rule for other rare diseases. For example SCID & RCC patients all go on the CRF track too.
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Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma (17-CMS-MM) NCT
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17-CMS-MM Primary Objective: Secondary Objectives:
To compare five-year OS probabilities between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients. Secondary Objectives: To compare five-year PFS probabilities between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients. Compare 5y survival of allos to autos The primary outcome is to compare five-year Overall Survival probabilities between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients. OS is calculated for all patients from the date of transplant until death from any cause Secondary outcomes: We will compare five-year Progression Free Survival probabilities between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients. Progression Free Survival is calculated as the interval from the date of transplant to the date of relapse/progression of MM or death from any cause, whichever comes first.
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17-CMS-MM CMS decision in June 2017 71 participating centers
Opened for enrollment in July 2017 HCT Arm Target Enrollment = 500 Current Enrollment = 4 Control Arm = 500 Auto HCT patients already in RDB on CRF track Target accrual 100 pts per year for 5 years Auto HCT cohort will come from patients already on CRF track in CIBMTR’s research database. At the end of accrual time, we will obtain our historical controls from autoHCT patients transplanted between 2010 and 2016 from the CIBMTR database and will obtain comprehensive data for analysis from matched controls was chosen to ensure enough patients with stage II-III
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17-CMS-MM Eligibility Criteria
Stage II or III multiple myeloma at diagnosis MM Classifications: MM-IgG, MM-IgA, MM-IgD, MM-IgE, MM-IgM (not Waldenstrom), MM-light chain only, MM-non secretory Are eligible to receive an alloHCT from any suitable allogeneic donor including umbilical cord blood Can have any allo donor type and any product It is anticipated that most patients will be 65 or older and that almost all will be 55 or older. But there is not restriction on younger patients Eligibility for alloHCT will be limited to MM patients with Stage II or III MM per CMS guidelines. Further eligibility will be according to local institutional practices. GVHD prophylaxis will be per institutional practices.
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17-CMS-MM Exclusion Criteria Stage 1 at diagnosis
But if they had a prior auto, relapsed within 18 months and then are stage II or III, they will be eligible. Patients who have received prior therapy on clinical trials or who are enrolled on clinical trials will be allowed. This will ensure the capture of the broadest range of high risk MM patients in whom the therapy will be used without exclusion based on race, gender or prior therapy.
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BMT CTN 1302 Allo Myeloma Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma Co-enrollment in 17-CMS-MM and CTN 1302 is allowed There are no restrictions on participating on other clinical trials for patients enrolled in 17-CMS-MM
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Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Adolescents and Young Adults with Severe Sickle Cell Disease (17-CMS-SCD) NCT
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17-CMS-SCD Primary Objective:
Compare the 5-year survival probabilities between patients with Sickle Cell Disease (SCD) who received allogeneic HCT to those who received standard of care Primary: Compare the 5-year survival probabilities between patients who received allogeneic HCT to those who received standard of care using the intent-to-treat (ITT) principle Note: the only outcome of interest for patients enrolled non-HCT arm is survival
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17-CMS-SCD Submitted to CMS in August 2017 47 participating centers
Opened for enrollment in Oct 2017 Target Enrollment = 200 Current Enrollment = 0 Non-HCT Arm = 1000 50 per year over 4 years Data for pts in non-HCT arm will provided by the 4 collaborating institutions. Johns Hopkins, Case Western, Children's hospital of Oakland, MCW Approximately 1000 patients will be available to form the non- HCT contemporary controls. Cases will be matched to 1-3 controls based on age (within the same decade) and time of onset of the indication for allogeneic HCT
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17-CMS-SCD Eligibility Criteria Age 15 – 50 years.
Sickle cell disease (HB SS, HB S beta thalassemia or HB SC) with severe signs or symptoms indicating poor prognosis and warranting transplantation. Stroke Neurological deficit lasting > 24 hours Recurrent acute chest syndrome (ACS) Recurrent pain crises Red blood cell (RBC) transfusions to prevent vaso-occlusive clinical complications (i.e. pain, stroke, or ACS) High tricuspid valve regurgitant jet velocity (TRJV) Rare for peds to have Medicare coverage but it is possible. The need to be on SS disability for 2 years to be eligible for Medicare coverage. Discussed in more detail later in presentation Need one or more risk factors Tricuspid regurgitation (insufficiency) is the failure of the tricuspid valve to close properly during systole, leading to the leaking of blood from the right ventricle into the right atrium .
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17-CMS-SCD Eligibility Criteria Exclusion Criteria
Donors may be HLA-matched unrelated donors, HLA-matched siblings, or mismatched relatives Donors with sickle cell trait are eligible to donate Product may be bone marrow, peripheral blood or umbilical cord blood Exclusion Criteria Previous allogeneic HCT Donors may be HLA-matched siblings, mismatched siblings or other relatives (parent, offspring or another relative mismatched to the recipient at 1 or more HLA loci), HLA-matched or mismatched donors. Donors with sickle cell trait are eligible to donate. Donors may donate bone marrow, peripheral blood or umbilical cord blood. Choice of optimal donor is at the discretion of the transplanting institution.
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Additional Required Forms
F2558 CMS – SCD Sickle Cell Disease Eligibility Form
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BMT CTN 1503 STRIDE2 A Study to Compare Bone Marrow Transplantation to Standard Care in Adolescents and Young Adults with Severe Sickle Cell Disease CTN 1503 is also a CMS CED study Co-enrollment in 17-CMS-SCD and CTN 1503 is not allowed BMT CTN 1503 (STRIDE2) was approved by CMS as having met the requirements of the National Coverage Determination (NCD) for Stem Cell Transplantation. For additional information, visit the CMS Website approval posting located here: CMS does not allow you to bill the same procedures to 2 different studies. 1503 is a Transplant vs Standard of care for SCD study and has CMS approval already, so does NOT allow co-enrollment on the SCD CMS study. If your center is a CTN center and the pt is eligible for 1503, you should enroll them in that study instead of 17-CMS-SCD. If your center is not a CTN participating center or the pt is not eligible for 1503, they should be enrolled in 17-CMS-SCD
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BMT CTN 1507 Haplo SCD Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease Co-enrollment in 17-CMS-SCD and CTN 1507 is allowed Enroll patients in both studies if they want Medicare to pay for the transplant. If the patient is not on Medicare, only enroll them in 1507. 1507 is not a CMS CED study The patient can be co-enrolled in 1507 and 17-CMS-SCD, but only use the NCT when billing claims to Medicare. Do not use the CTN 1507 NCT # or Medicare will deny the claim
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Medicare
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Medicare There is not a prior authorization process for Medicare CED studies. The patient must be clinically eligible for the study and have their transplant at a participating center. When the claim is filed, it must have an approved ICD-10 Diagnosis code and National Clinical Trial number (NCT) listed on the claim. ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), ICD-10 a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases NCT numbers are posted on the study pages cibmtr.org
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Medicare If patients have secondary Medicare coverage do they need to be registered for the CMS CED? Yes, if Medicare will be billed as primary or secondary they need to be enrolled.
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What about Medicaid? Medicaid coverage is controlled by state regulations, so the Medicare CED clinical trial policies do not apply. Check with your state’s Medicaid office to find out if they will cover it None of CIBMTR’s CMS CED studies offer coverage for Medicaid patients. These CED studies are specifically for Medicare coverage and unfortunately does not pertain to Medicaid coverage. However, your state Medicaid program may cover HCT for SCD so I encourage you to reach out to your local Medicaid office for more information.
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Pediatric Patients on Medicare
Children can qualify for Medicare benefits if They qualify for Social Security Disability benefits as determined by the Social Security administration Are disabled prior to the age of 22 years old. Have received SSDI benefits for at least 24 months Children can qualify for Medicare if they qualify for SSDI benefits and are disabled prior to the age of 22 years old. If your pt has a disability that entitles him or her to Social Security Disability Insurance (SSDI) payments, he or she may qualify for Medicare. They must have received SSDI benefits for at least 24 months in order to receive Medicare benefits. see checklist located here: The Center for Medicare and Medicaid Services (CMS) defines a child “as an unmarried person younger than 22 (or a person who is between the ages of 22-26, and who meets other requirements). Also, he or she must be the parent’s biological child, legally adopted child, stepchild (for at least 1 year), or a grandchild or step-grandchild (in some cases).” Once eligible, these children can benefit for Medicare services similarly to an adult patient.
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Need more information about Medicare?
For additional information regarding Medicare billing and claims, contact the NMDP/Be The Match Payer Policy team
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Questions?
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