Department of Health and Human Services October 12, 2006 – Federal Register Recent Federal Regulation Documents

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Managed Care Beneficiary Reconsideration (RECON) System,'' System No. 09-70-4003, last published at 67 Federal Register 48179 (July 23, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center within CMS that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0533. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS' intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain information necessary to process requests for reconsideration of service requests or claims by or on behalf of Medicare managed care enrollees, promote the effectiveness and integrity of the Medicare managed care program, and reply to future correspondence related to the case. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency; (3) assist third party contacts; (4) assist Quality Improvement Organizations; (5) support litigation involving the agency; and (6) combat fraud, waste, and abuse in Federally-funded health benefit programs. We have provided background information about the modified 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 modified or altered 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 announcing the availability of a guidance for industry entitled ``Investigating Out- of-Specification (OOS) Test Results for Pharmaceutical Production.'' This guidance provides information for the pharmaceutical industry on how to evaluate laboratory test results that fall outside of specification limits. The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements.

This notice announces the ninth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).