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Best Pract Res Clin Gastroenterol. 2011 Jun;25(3):409-17. doi: 10.1016/j.bpg.2011.05.011.

Medico-legal aspects and concerns in quality assurance in the United States.

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  • 1Stevens & Lee, Lancaster, PA 17602, United States.


Quality assurance data - essential to successful efforts to improve the quality and efficiency of healthcare - is more important than ever in today's environment. Robust quality assurance activities are required to achieve the accreditation necessary to obtain Medicare reimbursement and for participation in the Accountable Care Organization shared savings programs proposed by the Centers for Medicare and Medicaid Services ("CMS"). The federal government and US states require reporting of quality assurance data to a variety of independent and governmental agencies. Commercial insurance carriers and innovative employers are developing new reimbursement models that require demonstrable achievement of quality performance standards based on quality performance data. Such data can consist of both aggregate performance information and individualized outcomes. This chapter reviews the potential vulnerabilities of quality assurance programs and data and the legal concerns related to disclosure of the information. Available legal protections and some effective strategies for protecting that information are also discussed. This information will enable providers to develop effective quality assurance programs structured to maximize opportunities to protect the confidentiality of the data.

Copyright © 2011 Elsevier Ltd. All rights reserved.

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