Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials

Navneet S Majhail; Sergio Giralt; Anthony Bonagura; Stephen Crawford; Stephanie Farnia; James L Omel; Marcelo Pasquini; Wael Saber; Charles F LeMaistre

doi:10.1016/j.bbmt.2014.12.030

Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials

Biol Blood Marrow Transplant. 2015 Apr;21(4):583-8. doi: 10.1016/j.bbmt.2014.12.030. Epub 2015 Jan 29.

Authors

Navneet S Majhail¹, Sergio Giralt², Anthony Bonagura³, Stephen Crawford⁴, Stephanie Farnia⁵, James L Omel⁶, Marcelo Pasquini⁷, Wael Saber⁷, Charles F LeMaistre⁸

Affiliations

¹ Blood and Marrow Transplant Program, Cleveland Clinic, Cleveland, Ohio. Electronic address: [email protected].
² Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York.
³ Optum Health, Minneapolis, Minnesota.
⁴ Cigna LifeSource Transplant Network, Pittsburgh, Pennsylvania.
⁵ National Marrow Donor Program, Minneapolis, Minnesota.
⁶ Grand Island, Nebraska.
⁷ Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin; Center for International Blood and Marrow Transplant Research, Milwaukee, Wisconsin.
⁸ Sarah Cannon, Nashville, Tennessee.

PMID: 25639771
DOI: 10.1016/j.bbmt.2014.12.030

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.

Keywords: Affordable Care Act; Clinical trials; Costs; Hematopoietic cell transplantation; Routine care; Standard of care.

Publication types

Review

MeSH terms

Clinical Trials as Topic
Costs and Cost Analysis
Guidelines as Topic
Hematopoietic Stem Cell Transplantation / economics*
Hematopoietic Stem Cell Transplantation / methods*
Hematopoietic Stem Cell Transplantation / standards*
Humans