The ACBSCT met on May 5, 2010, in Bethesda, Maryland, and unanimously agreed on its seventh, eighth and ninth recommendations.
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ACBSCT recommends to the Secretary that an expert panel be convened to review and determine indications for stem cell transplantation.
Allogeneic hematopoietic transplantation is an effective, potentially curative treatment for a broad range of hematologic, malignant, immunologic and genetic diseases. It is important that patients have access to this treatment modality. Public and private medical insurance providers have independently determined which diagnoses should be covered. There is no authoritative body which determines the accepted indications for hematopoietic transplantation, and there is considerable variability in coverage policies and covered diagnoses. Some payers have different criteria for related and unrelated donor transplants, degrees of HLA matching and different hematopoietic cell sources.
The ACBSCT recommends that an expert panel be convened, including experts regarding hematopoietic transplantation, experts in the candidate diseases, and representatives of the medical insurance industry, public payers and patient advocates, to develop a consensus, evidence-based list of diagnoses for which hematopoietic transplantation is an accepted standard of care. The expert panel should also consider whether there should be different indications for related and unrelated donor transplants, degrees of HLA match and mismatch, and different hematopoietic cell sources (bone marrow, peripheral blood progenitor cell, cord blood transplants). This panel will publish its conclusions and meet from time to time to update this listing. The panel will report to the ACBSCT Council, which will make recommendations to the Secretary.
ACBSCT recommends that the Secretary mandate that Medicare and Medicaid cover patient participation in clinical trials involving hematopoietic transplantation.
Hematopoietic transplantation is a rapidly evolving area where incremental changes in treatment and supportive care have progressively improved safety and treatment outcomes. This has occurred through clinical trials. Improved approaches for hematopoietic transplantation are needed. New and promising treatments are being rapidly designed to improve safety and effectiveness.
It is important that patients have access to participate in clinical trials. Many insurance carriers do not cover standard patient care costs for patients participating in clinical trials. This deprives patient access to the most promising new treatments and limits the further vital improvements in the standards of care for hematopoietic transplantation.
Some years ago, a Presidential Executive Order mandated that Medicare cover patient care costs for clinical trials, but this has not been effectively implemented for studies of hematopoietic transplantation. Many States have laws requiring insurance carriers to cover standard patient care costs while participating in clinical trials, and this is included in the recent federal health care reform legislation, but only becomes active in 2014. This remains a major problem for patients.
The ACBSCT recommends that the Secretary mandate that Medicare and Medicaid cover the standard patient care costs for patients who are participating in clinical trials involving the use of hematopoietic transplantation and supported by or conducted under the auspices of the National Institutes of Health or National Cancer Institute (NCI), NCI-designated cancer centers and cooperative groups, the Department of Veterans Affairs, or a Food and Drug Administration Investigational New Drug (IND)/Investigational Device Exception (IDE). The ACBSCT recommends that the Secretary encourage private insurance carriers to immediately provide coverage for standard patient care costs for patients participating in clinical trials involving hematopoietic transplantation.
ACBSCT recommends to the Secretary that cord blood collections be increased and improved.
Awareness of cord blood donation and the procurement of high quality products is critical to providing life saving cord blood grafts for patients in need of stem cell therapies. Collection practices yielding larger cord blood units, particularly from ethnically and racially diverse donors, will increase access to curative treatments for patients in need.