Department of Health and Human Services September 23, 2005 – Federal Register Recent Federal Regulation Documents
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Stakeholder Meeting on the Implementation of A New Direction for the Food and Drug Administration's Radiological Health Program; Public Meeting
The Food and Drug Administration (FDA) is announcing the following public meeting: A New Direction for FDA's Radiological Health Program. The topics of discussion are the agency's activities to implement its radiological health program (the program).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Medicaid Program; Disproportionate Share Hospital Payments
This document corrects a technical error that appeared in the proposed rule published in the Federal Register on August 26, 2005 entitled ``Medicaid Program; Disproportionate Share Hospital Payments.''
Cooperative Agreement for Border Health Best Practices
The Office of Rural Health Policy (ORHP), in cooperation with the Office of Global Health Affairs (OGHA), Office of Minority Health (OMH), Office on Women's Health (OWH), and Centers for Disease Control and Prevention (CDC) will award a one year single source award to the U.S.-Mexico Border Health Association (USMBHA) to identify and promote best practices in border communities. As defined in the La Paz Agreement, the border region is 100 km north and south of the international boundary line between the United States and Mexico. Funds will be used on both sides of the U.S.-Mexico border for the development of activities under the second annual Border Binational Health Week (October 10-16, 2005).
Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Chicago, Illinois'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Chicago, IL. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Chicago, IL, November 7 through 10, 2005, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on October 20, 2005, from 1:30 p.m. to 4 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd Fl., Maryland Conference Room, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 1:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to the Maryland Conference Room. Contact: Sema Hashemi, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by October 14, 2005. If you need special accommodations due to a disability, please contact Sema Hashemi at least 7 days in advance.
Memorandum of Understanding Between the Food and Drug Administration and the Food and Drug Administration Alumni Association
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Food and Drug Administration Alumni Association, Inc. The purpose of this MOU is to establish a greater collaboration between FDA and the Food and Drug Administration Alumni Association, Inc., regarding FDAs 2006 Centennial Observance.
HIPAA Administrative Simplification: Standards for Electronic Health Care Claims Attachments
This rule proposes standards for electronically requesting and supplying particular types of additional health care information in the form of an electronic attachment to support submitted health care claims data. It would implement some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2005
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2005 through June 2005, 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.
Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting-October 26, 2005 Through October 28, 2005
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the third meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the third meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-November 29, 2005
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). 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 concerns the treatments for age-related macular degeneration. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Criteria and Standards for Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2006
This notice describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FIs), carriers, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) regional carriers in the administration of the Medicare program beginning on the first day of the first month following publication of this notice in the Federal Register. The results of these evaluations are considered whenever we enter into, renew, or terminate an intermediary agreement, carrier contract, or DMEPOS regional carrier contract or take other contract actions, for example, assigning or reassigning providers or services to an intermediary or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.
Medicare and Medicaid Programs; Application by the Accreditation Commission for Healthcare for Deeming Authority for Home Health Agencies
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Healthcare for recognition as a national accreditation program for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Part A Premium for Calendar Year 2006 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2006. This premium is to be paid by enrollees age 65 and over who are not otherwise eligible (hereafter known as the ``uninsured aged'') and for certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2006 for these individuals will be $393. The reduced premium for certain other individuals as described in this notice will be $216. Section 1818(d) of the Social Security Act specifies the method to be used to determine these amounts.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2006
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2006 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2006, the inpatient hospital deductible will be $952. The daily coinsurance amounts for CY 2006 will be: (a) $238 for the 61st through 90th day of hospitalization in a benefit period; (b) $476 for lifetime reserve days; and (c) $119.00 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible for Calendar Year 2006
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2006. In addition, this notice announces the monthly premium for aged and disabled beneficiaries and the annual deductible to be paid during 2006. The monthly actuarial rates for 2006 are $176.90 for aged enrollees and $203.70 for disabled enrollees. The monthly Part B premium rate for 2006 is $88.50 which is equal to 50 percent of the monthly actuarial rate for aged enrollees or about 25 percent of Part B costs for aged enrollees. (The 2005 premium rate was $78.20.) The Part B deductible for 2006 is $124.00.
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