Ethical considerations in CMS's coverage with evidence development.

This paper reviews the CMS coverage with evidence development policy, its manner of implementation, and key ethical issues raised by the policy. The author describes ethical considerations and issues associated with the process of coverage with evidence development for generating evidence for novel or emerging technologies.

Access to oral health care: Professional and societal considerations.

Access to health care is a complex subject with vast personal, economic, political, and societal ramifications. Issues concerning the rights and responsibilities of health care professionals-collectively and as individual members of a profession-comprise an important topic within ongoing debates concerning access to care, and constituted the overarching focus of the deliberations that form the basis of this publication. This article provides definitions of key terms; data concerning demography, oral health status, and use of dental services for children and seniors; and a contextual framework for examining broad underlying professional and societal considerations. It concludes with reflections on joint responsibilities and guiding principles that apply to dental professionals and government agencies charged with administering public benefits programs and the consequences likely to ensue if these vital stakeholders fail to respect fundamental principles of professionalism and economics.

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.