Impact of CMS Regulations on Transplantation

Almost everything we do in transplantation is more tightly regulated and monitored than a decade ago. It strikes me that some of this is warranted, some maybe not. Our field, evolving after implementation of the Medicare ESRD program and development of cyclosporine, has always been more closely scrutinized than other areas of medicine. The benefits? Standardization of clinical care has improved outcomes and the burden of regulation has favored larger programs better equipped to deal with it.. Our experience should also be informative to those likely to face new stresses in dealing with the next decade of broader regulation across all of medicine. The harms? Smaller centers have filled an important niche in patient access, and will be missed. Perhaps we have all become too concerned with compliance, with unintended consequences of impaired availability of transplantation to needy patients. At AST, we have attempted to address new regulation by ensuring it is consistent with best practices.

Should we be bolder? Are there more threats on the horizon? For small centers?

How might we better anticipate what is coming? Do you feel adequately informed in this arena?

Robert S. Gaston

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