title: Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials.
abstract: The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation.
authors: Blood and Marrow Transplant Program, Cleveland Clinic, Cleveland, Ohio. Electronic address: majhain@ccf.org.
authors: Navneet S
authors: NS
authors: Majhail
authors: Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York.
authors: Sergio
authors: S
authors: Giralt
authors: Optum Health, Minneapolis, Minnesota.
authors: Anthony
authors: A
authors: Bonagura
authors: Cigna LifeSource Transplant Network, Pittsburgh, Pennsylvania.
authors: Stephen
authors: S
authors: Crawford
authors: National Marrow Donor Program, Minneapolis, Minnesota.
authors: Stephanie
authors: S
authors: Farnia
authors: Grand Island, Nebraska.
authors: James L
authors: JL
authors: Omel
authors: Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin; Center for International Blood and Marrow Transplant Research, Milwaukee, Wisconsin.
authors: Marcelo
authors: M
authors: Pasquini
authors: Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin; Center for International Blood and Marrow Transplant Research, Milwaukee, Wisconsin.
authors: Wael
authors: W
authors: Saber
authors: Sarah Cannon, Nashville, Tennessee.
authors: Charles F
authors: CF
authors: LeMaistre
mesh_terms: D002986:Clinical Trials as Topic; D003365:Costs and Cost Analysis; D017408:Guidelines as Topic; D018380:Hematopoietic Stem Cell Transplantation / Q000191:economics* / Q000379:methods* / Q000592:standards*; D006801:Humans
keywords: Affordable Care Act; Clinical trials; Costs; Hematopoietic cell transplantation; Routine care; Standard of care