National Coverage Policy Sought

for Allo Transplants for MDS under Medicare

Allogeneic stem cell transplants for myelodysplastic syndrome (MDS) would be consistently eligible for Medicare reimbursement if the federal government accepts a formal request that has been submitted by ASBMT and the National Marrow Donor Program (NMDP), together with 10 other organizations.

“We believe that the body of evidence supports a coverage policy that ensures that Medicare beneficiaries diagnosed with MDS have access to allogeneic HCT,” said a letter asking for a national coverage determination, submitted Sept. 21 to the Centers for Medicare and Medicaid Services (CMS). 

Medicare patients age 65 and older represent 80 percent of the total population diagnosed with MDS in the United States.  For some of these patients, allogeneic hematopoietic cell transplantation (HCT) is the only available curative therapy and the only treatment that can prevent certain death from the disease.

Inconsistent Coverage

Currently some Medicare regional contractors for Part A (hospital) and Part B (physician) services do reimburse for stem cell transplants for MDS, but coverage is inconsistent across the country.  Each instance may require extensive justification of the efficacy of allogeneic transplants for MDS.  Without an explicit and well-defined national policy, hospitals often are reluctant to extend HCT services to Medicare beneficiaries who would benefit.  A national coverage determination would guarantee appropriate and timely access to curative treatment for MDS under the federal health programs.

After months of gathering evidence to document a request, ASBMT and NMDP met with CMS representatives in February for preliminary discussion about applying for a national coverage determination.  The outcome was encouraging enough to proceed with assembling a coalition of organizations to submit a formal request.  Those joining in the petition are:

·      AABB (formerly the American Association of Blood Banks)

·      American Cancer Society

·      American Cancer Society Cancer Action Network

·      American Society for Hematology

·      American Society of Clinical Oncology

·      Aplastic Anemia and MDS International Foundation

·      Blood & Marrow Transplant Information Network

·      National Bone Marrow Transplant Link

·      The Bone Marrow Foundation

·      The Leukemia & Lymphoma Society

Several other organizations have indicated that they will support the request during an expected period for public comment.

Included in the documentation submitted to CMS was an evidence-base review of the scientific and medical literature published in February this year, part of the ongoing series of comprehensive reviews of indications for HCT that ASBMT has sponsored and NMDP has supported over the past 10 years.  Each review is conducted by a multidisciplinary panel of experts. 

Another important part of the documentation was a study conducted by the Center for International Blood and Marrow Transplant Research (CIBMTR) showing that outcomes for older adults undergoing allogeneic HCT for MDS are not significantly different than those of younger adults, even after adjusting for multiple risk factors.  The analysis, presented last year at the American Society of Hematology annual meeting, revealed no statistically significant impact of age on transplant-related mortality, relapse, leukemia-free survival or overall survival.  The report has been submitted for publication.

“The study involved 551 MDS patients in the CIBMTR database who were transplanted from 1995 to 2005," said Claudio Anasetti, MD, ASBMT president.  "The analysis concluded that age by itself should not be a limiting factor for proceeding with allogeneic HCT in older MDS patients.”

Safety and Quality

According to Michael Boo, JD, the NMDP's chief strategy officer, another important element in the petition was to show a high degree of safety and quality for all allogeneic HCTs for MDS and an ability to track and analyze outcomes of care for Medicare patients. 

“For safety and quality we referenced NMDP standards and the transplant provider and facility standards and accreditation of the Foundation for the Accreditation of Cellular Therapy (FACT),” Boo said.  “For ongoing evaluation of outcomes, we offered the capabilities of the federally mandated data collection of the Stem Cell Therapeutics Outcomes Database (SCTOD), which is maintained by the CIBMTR.”

MDS becomes more common as people age.  In the United States, the overall incidence of MDS is estimated at 3.3 per 100,000, but the incidence in patients over 70 is between 15 and 50 per 100,000, according to recently published epidemiological data.

CMS may seek additional information prior to a period for public comment.  A decision on the request isn’t expected until next year.