Department of Health and Human Services June 23, 2006 – Federal Register Recent Federal Regulation Documents
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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 015
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 015'' (Recognition List Number: 015), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Medicare and Medicaid Programs; Denial of the TÃœV Healthcare Specialists Request for Deeming Authority for Hospitals
This final notice announces our decision to deny T[Uuml]V Healthcare Specialists' (T[Uuml]VHS) request for deeming authority for hospitals that wish to participate in the Medicare and Medicaid programs.
Medicare Program; Second Biannual Meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups-August 23, 24, and 25, 2006
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2006. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2007.
Medicare Program; Identification of Backward Compatible Version of Adopted Standard for E-Prescribing and the Medicare Prescription Drug Program (Version 8.1)
This interim final rule with comment period identifies the Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8.1 (hereafter referred to as ``Version 8.1 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard'') as a backward compatible update of the adopted Version 5.0. This interim final rule with comment period also permits the voluntary use of Version 8.1 of the NCPDP SCRIPT Standard for conducting certain e- prescribing transactions for the electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-August 30, 2006
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC) (``Committee''). Among other things, the Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will discuss the following issues: (1) Glycemic control and the use of glucose monitors by which sensors automatically monitor glucose levels in body fluids; and (2) whether and how the frequency of outpatient glucose monitoring is related to glycemic control and clinical outcomes in the various Medicare populations. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2006
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2006 through March 2006, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
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