Department of Health and Human Services August 5, 2005 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting and hearing of the Citizens' Health Care Working Group mandated by section 1014 of the Medicare Modernization Act. In addition, the Working Group will sponsor a community forum in which members of the working group will participate.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 60/508,750, filed October 3, 2003 [DHHS Ref. E-075- 2003/0-US-01] and PCT Application PCT/US04/32649 [DHHS Ref. E-075-2003/ 0-PCT-02], entitled Use of Cripto-1 as a Biomarker for Neurodegenerative Disease and Method of Inhibiting Progression Thereof, to Neuronascent, Inc., which is located in Clarksville, Maryland. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development and use of Cripto small molecule inhibitors to treat and prevent Alzheimer's disease in humans.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled ``Federal Reimbursement of Emergency Health Services Furnished to Undocumented Aliens (Section 1011),'' System No. 09-07-0546. The system will contain enrollment and payment request information, in support of a short-term program which pays hospitals, certain physicians, and ambulance providers (including Indian Health Service (IHS) facilities whether operated by the IHS or by an Indian Tribe or tribal organization) for their otherwise un-reimbursed costs of services provided under the provisions of section 1867 (Emergency Medical Treatment and Labor Act) (EMTALA) of the Social Security Act (the Act) and related hospital inpatient and outpatient services and ambulance services furnished to undocumented aliens, aliens paroled into the United States (U.S.) at a U. S. port of entry for the purposes of receiving such services, and Mexican citizens permitted temporary entry to the U.S. for not more than 30 days under the authority of a biometric machine readable border crossing identification card (also referred to as a ``laser visa'') issued in accordance with the requirements of regulations prescribed under the Immigration and Nationality Act. This system is being established under provisions of Section 1011 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 Modernization Act of 2003 (MMA). The primary purpose of the system is to maintain information collected on individuals who submit an enrollment application and make payment requests associated with Section 1011 of the MMA, and other information designed to support the enrollment, claims payment, and research reporting functions of the Section 1011 program. Information retrieved from this system will also be disclosed to: (1) Support regulatory, payment activities, and policy functions performed within the agency or by a designated contractor or consultant; (2) combat fraud and abuse in certain health benefits programs; (3) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal; (4) funds support constituent requests made to a Congressional representative; and, (5) support litigation involving the agency. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See DATES section for comment period.