Medicare Coverage Update: Myelofibrosis CED Study Information
On October 17, 2016 the Centers for Medicare and Medicaid Services (CMS) approved the CIBMTR study “16-CMS-MF: Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Myelofibrosis” (NCT02934477) as fulfilling requirements for Coverage with Evidence Development (CED). This provides Medicare eligible patients with a diagnosis of Myelofibrosis (MF) access to Medicare coverage for allogeneic Hematopoietic Stem Cell Transplant (HCT) when they participate in the clinical study under the CED mechanism.
CIBMTR has put processes in place to facilitate this study. Study information and updates can be found on the CIBMTR website.
The study utilizes the CIBMTR Observational Research database protocol and consent form. If your center already participates in the CIBMTR Observational Research database, additional IRB approval for this study is not specifically required. If your institution does require submission of the study protocol, follow your standard processes per your IRB. To be eligible for coverage, patients must consent to participate in research since the purpose of the CED is to provide coverage while obtaining research information to guide future policy decisions.
To notify the CIBTMR of your intent to participate in 16-CMS-MF, a Center Intent to Participate form must be submitted as soon as possible. This form confirms your understanding of the requirement to submit Comprehensive Report Forms (CRF) and the supplemental MF forms for all Myelofibrosis patients. This form must be signed by your centers Medical Director. This form was sent to centers in a December 1st email from CIBMTR. Please send completed form to email@example.com.
Billing and Coding Logistics:
There is not a prior authorization process for Medicare CED studies. In order to participate, a 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 (NCT02934477) listed on the claim. A separate communication will be sent from the NMDP Payer Policy team with more information once CMS issues the technical guidance. This link provides some initial coding guidance information.
New ICD-10 Coding Crosswalk Available
Check out our new tool that crosswalks inpatient procedure codes from ICD-9 to the changes released this October with ICD-10.
Prior to ICD-10 implementation transplant centers used ICD-9 codes to specify the donor source for allogeneic transplants. When ICD-10 was implemented these codes were no longer available. New donor source codes were introduced with the annual coding changes in October. View detailed information and background.
MLN Matters Clarification
CMS issued an MLN Matters article in the Office of the Inspector General Report on Stem Cell Transplant on November 22. There are many inaccurate statements regarding HCT in outpatient and inpatient settings. We have reached out to CMS and urged them to remove the article. In the meantime, our team is working to revise the article and additional information documents with accurate information about HCT in the inpatient and outpatient setting as well as coding.
Advocate Profile: Leslie Parran
||"To be honest, I never thought at the beginning of my career that it would make a difference to participate in advocacy," says Leslie Parran, Senior Director of Nursing and Blood and Marrow Transplant program at the University of Minnesota. She's been in the field since 1979.
Leslie's first venture into advocacy came when she went to Washington, D.C. with the Oncology Nursing Society to talk with legislators about nursing issues. A number of years later, she again participated in legislative activity when her organization went to the Minnesota state capitol.
These first experiences demonstrated to her how advocacy can influence decision-makers' actions. "So when the call to action came from NMDP / Be the Match, I felt compelled to participate." On numerous occasions Leslie has submitted comments to legislators and policy makers in support of funding for the C.W. Bill Young Cell Transplantation Program and for changes to hospital outpatient and inpatient rules to improve reimbursement for transplant.
"While all of us may feel the day-to-day local pressures of our work, it is important to take time to advocate on behalf of all HCT patients. If we don't, we may be impacted by decisions that are not influenced by us. Others may make decisions with limited information and understanding of the impacts to our patients and organizations. It is also rewarding to dialog with legislators as a concerned constituent and be acknowledged in person or in writing for presenting your perspectives on issues that directly impact your work and your patients."
When asked, Leslie explains that the work that NMDP / Be The Match is doing to expand coverage for a broader range of diagnoses with CMS is extremely relevant -- expanding coverage is critical to many patients."
"I would encourage clinicians and administrators to begin by learning about the Payer Policy and Legislative work the NMDP is doing. Then, respond to the calls for action -- they make it easy for all of us." The more people participating in advocacy the greater the likelihood to influence decisions that affect patients and families.
NMDP/ASBMT Comment Letter to CMS Regarding Network Adequacy in HIX Plans
The NMDP/Be The Match and the ASBMT recently submitted a comment letter to CMS regarding network adequacy in health insurance exchange (HIX) plans. In the 2018 Draft Letter to Issuers, CMS asked for comments about network adequacy specifically looking at high-cost treatments and oncology. Our comment letter strongly recommended that CMS require all health insurance exchange plans to have at least one transplant center in network to ensure timely patient access to life-saving treatment.
Sickle Cell Disease CED Study Sites Open
BMT CTN 1503, the Medicare approved sickle cell disease trial for coverage with evidence development (CED) recently opened at the Washington University, University of Iowa and Children’s Hospital of Atlanta. We will announce open sites in our eNews as they become available.
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If you have any questions or need additional information, please contact the Payer Policy Team at PayerPolicy@nmdp.org. All of our resources are available on our website: Network.BeTheMatchClinical.org/Reimbursement.