Regulatory oversight in transplantation: are the patients really better off?Hamilton, Thomas E.Current Opinion in Organ Transplantation: April 2013 - Volume 18 - Issue 2 - p 203–209 doi: 10.1097/MOT.0b013e32835f3fb4 REGULATORY, FINANCIAL AND ETHICAL CONSIDERATIONS IN TRANSPLANTATION: Edited by Anton I. Skaro Abstract Author Information Purpose of review: This article conveys early findings with respect to changes in patient and graft survival since Centers for Medicare & Medicaid Services (CMS) regulations for Medicare coverage of solid organ transplantation became effective on 28 June 2007. Recent findings: Programmes cited by CMS for subpar outcomes have strong incentives to improve performance and have risen to the challenge. Adult kidney programmes that entered into System Improvement Agreements or were approved for mitigating factors by CMS, for which there is a 2-year postsurvey tracking period (N = 15), improved their standardized mortality ratio (SMR) for 1-year posttransplant patient survival from 2.05 to 1.17 on average. Volume in some of those programmes tended to decline, whereas national volume increased. Nationally, average donor risk across U.S. adult kidney transplant programmes increased approximately 6% from CY2001 through CY2010. Average recipient risk also increased. Despite increased risk profiles, national survival rates for all organ types continued to increase from 2007 through 2010. Summary: People who receive transplants from programmes cited by CMS for subpar outcomes tend to have much improved prospects for posttransplant survival. Individuals waitlisted in those programmes may face lower odds of receiving a transplant, at least temporarily, due to the tendency of such programmes to reduce volume as they regroup to improve their outcomes. Survey & Certification Group, Centers for Medicare & Medicaid Services, Baltimore, Maryland, USA Correspondence to Thomas E. Hamilton, Survey & Certification Group, Centers for Medicare & Medicaid Services, Mailstop C2-21-12, 7500 Security Blvd, Baltimore, MD 21244, USA. Tel: +1 410 786 9493; fax: +1 410 786 0194; e-mail: email@example.com © 2013 Lippincott Williams & Wilkins, Inc.