AUCDigest

December 12, 2007 • Volume 7, Number 11


REQUESTS FOR INFORMATION OR ASSISTANCE

Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) Request Comments on Genetic Testing Report. Comment deadline: December 21, 2007. In March 2007, the Secretary of HHS developed a specific charge for SACGHS to participate in “the development of a comprehensive map of the steps needed for evidence development and oversight for genetic and genomic tests, with improvement of health quality as the primary goal.” The draft is entitled, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS.

Medicaid Definition of Covered Case Management Services Clarified. Deadline for comments: January 30, 2008. The Centers for Medicare & Medicaid Services (CMS) interim final rule with comment period (IFC) implementing section 6052 of the Deficit Reduction Act of 2005 (DRA) clarifies the Medicaid definition of covered case management and targeted case management (TCM) services.

Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity. Comment Period deadline has been extended to January 14, 2008. Currently, the Office for Human Research Protections (OHRP), Office of Public Health and Science (OPHS), at the Department of Health and Human Services have broad requirements that address the “rights and welfare” of those who are “likely to be vulnerable to coercion or undue influence.” HHS now wants views on whether or not current regulations are enough to protect vulnerable adults and comments on the need for specific additional standards for this population.