Department of Health and Human Services November 23, 2005 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing a new SOR titled, ``National Disaster Medical System (NDMS) Claims Processing System (CPS), No. 09-70-0572.'' CMS is responsible for establishing and administering a payment mechanism for definitive medical care provided under the National Disaster Medical System (NDMS) in accordance with section 2811 of the Public Health Service Act, 42 United States Code (U.S.C.) 300hh-11, a Memorandum of Agreement (MOA) entered into by the NDMS Partnersthe Departments of Homeland Security, Health and Human Services, Defense, and Veteran's Affairs, and an Inter-Agency Agreement between CMS and the Federal Emergency Management Agency (FEMA). Reimbursement to NDMS-participating hospitals (and practitioners furnishing medical services to NDMS- authorized patients during inpatient stays in those hospitals) for definitive medical care will be administered through the NDMS-CPS. The new system will collect data relating to individuals who receive NDMS- authorized medical treatment or services in NDMS hospitals for illness or injury resulting from a specified public health emergency or non- deferrable medical treatment or services to maintain health when such are temporarily not available as a result of the public health emergency. Data on individuals will be submitted by the Departments of Defense and Veteran's Affairs, staffed Federal Coordinating Centers activated by the NDMS, NDMS hospitals, and practitioners within NDMS hospitals that furnish medical treatment or services to NDMS patients. The primary purpose of the system is to justify and document payments for inpatient hospital and related practitioner services provided in connection to the NDMS. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by CMS and the NDMS Partners, contractors (including the NDMS claims contractor), and consultants contracted by the Agency; (2) support another Federal (including the NDMS Partners) agency of a state government, an agency established by state law, or its fiscal agent; (3) assist NDMS-participating hospitals (and practitioners within those hospitals) who have furnished services to individuals evacuated and placed by the NDMS; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (6) support constituent requests made to a congressional representative; (7) support litigation involving the Agency, and (8) combat fraud and abuse in certain Federal health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.