@article{50b74ded161245b1b717ddfa878ba534,
title = "Should Both UNOS and CMS Provide Regulatory Oversight in Kidney Transplantation?",
abstract = "Since publication of the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation Final Rule in 2007, there has been dual regulation of transplant centers by the Organ Procurement and Transplantation Network (OPTN) contractor the United Network for Organ Sharing (UNOS) and CMS. Herein, we summarize the environment leading to the development of the present regulatory framework and identify significant and unintended consequences of the current regulations.",
keywords = "Medicare, Program specific reports, Regulation, Transplantation, UNOS",
author = "Bing Ho and Skaro, {Anton I.} and Abecassis, {Michael M.}",
note = "Funding Information: To address the nation{\textquoteright}s critical organ donation shortage and improve the organ matching and placement process, the National Organ Transplant Act (NOTA) was passed in 1984 and amended in 1988 and 1990 []. NOTA was sponsored by Representative Al Gore and Senator Orrin Hatch and signed into law by President Ronald Reagan. In brief, NOTA created a task force to study medical, legal, ethical, economic, and social issues presented by human organ procurement and transplantation. This included issues related to immunosuppressive medications, education, training, barriers, and insurance reimbursement. NOTA also outlawed the sale of organs in response to private enterprises such as the International Kidney Exchange, founded by Virginia physician H. Barry Jacobs []. Revised in 1998, NOTA{\textquoteright}s Title II—Organ procurement activities directed the Secretary of Health and Human Services (HHS), Donna Shalala at the time, to establish Organ Procurement Organizations for deceased donor transplants, the membership organization Organ Procurement and Transplantation Network (OPTN) and a data repository eventually known as the Scientific Registry of Transplant Recipients (SRTR). Both the OPTN and SRTR are required by law to be under contract by a private nonprofit entity. NOTA was further amended in 1990 to create the National Bone Marrow Donor Registry as well as minor amendments to existing procurement and transplantation authorities. More recently, legislation was introduced which dealt with kidney paired donation ensuring that this practice was not considered valuable consideration. Figure depicts a current organization chart of CMS, Health Resources and Services Administration (HRSA), OPTN, and SRTR as well as reporting requirements. Publisher Copyright: {\textcopyright} 2015, Springer International Publishing AG.",
year = "2015",
month = jun,
day = "1",
doi = "10.1007/s40472-015-0062-9",
language = "English (US)",
volume = "2",
pages = "127--134",
journal = "Current Transplantation Reports",
issn = "2196-3029",
publisher = "Springer International Publishing AG",
number = "2",
}