Testimony by Employees and the Production of Documents in Proceedings Where the United States Is Not a Party

This rule amends Part 2 of Title 45 of the Code of Federal Regulations, which provides that employees and former employees of the Department of Health and Human Services (HHS or Department) may not provide testimony as part of their official duties in litigation where the United States or a federal agency is not a party, without the approval of the head of the agency. The purpose of these amendments is to modify the definition of "employee" contained in 45 CFR part 2. Under these amendments, the definition of employee will be revised to reflect changes in Medicare contracting, including changes brought about by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). In addition, the definition of employee will be modified to include employees of a state agency performing survey, certification, or enforcement functions under Title XVIII of the Social Security Act or Section 353 of the Public Health Service Act. Further, the definition of employee with respect to employees of entities covered by the Federally Supported Health Centers Assistance Act, as amended, 42 U.S.C. 233(g)-(n) (FSHCAA), will be limited to testimony requested in medical malpractice tort litigation which relates to medical functions performed at a time when the center was covered under FSHCAA.