Department of Health and Human Services January 27, 2006 – Federal Register Recent Federal Regulation Documents

Medicare Program; Meeting of the Medicare Coverage Advisory Committee-March 30, 2006
Document Number: E6-704
Type: Notice
Date: 2006-01-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee generally 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. The charter also permits the MCAC to develop recommendations about other specific issues of Medicare coverage. This meeting concerns authoritative drug compendia that may be used in determining the medically accepted indications of drugs and biologicals used in an anti-cancer chemotherapeutic regimen under Part B of the Medicare program. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 6, 2006
Document Number: E6-702
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Determination of Regulatory Review Period for Purposes of Patent Extension; SPIRIVA HANDIHALER
Document Number: E6-1050
Type: Notice
Date: 2006-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SPIRIVA HANDIHALER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Medicare Program; Approval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
Document Number: E6-1049
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
In this final notice we respond to public comments on our September 30, 2005 notice with comment period and announce our decision concerning an application submitted by Advanced Medical Optics (AMO) to adjust the Medicare payment amounts for certain intraocular lenses (IOLs) on the basis that they are new technology intraocular lenses (NTIOLs). This is the third of three statutorily required Federal Register documents. On May 27, 2005, we published a notice in the Federal Register entitled ``Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70 FR 30731) that solicited interested parties to submit requests for review of the appropriateness of the payment amount for an IOL furnished by an ambulatory surgical center. On September 30, 2005, we published a notice with comment period entitled ``Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70 FR 57297) acknowledging timely receipt of one application. In this final notice, we announce our decision to approve the NTIOL application submitted by Advanced Medical Optics (AMO) for Tecnis[supreg] (model numbers Z9000, Z9001, and Z9003).
Control of Communicable Diseases
Document Number: E6-1048
Type: Proposed Rule
Date: 2006-01-27
Agency: Department of Health and Human Services
On November 30, 2005, at 70 FR 71892, CDC published a proposed rule, ``Control of Communicable Diseases,'' to revise existing regulations related to preventing the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. and from one state or possession into another. CDC provided a 60 day public comment period. Written comments were to be received on or before January 30, 2006. We have received requests asking for an extension of the comment period. In consideration of these requests, CDC is extending the comment period by 30 days to March 1, 2006.
Proposed Collection; Comment Request-National Network of Tobacco Cessation Quitlines Evaluation
Document Number: E6-1020
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Nomination To Hold a Workshop on Alternative Methods To Replace the Mouse LD50
Document Number: E6-1019
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
In October 2005, the Humane Society of the United States (HSUS) submitted a nomination to NICEATM requesting that alternative test methods to the mouse LD50 assay for botulinum toxin potency testing be assessed and prioritized for prevalidation and validation efforts. The nomination proposed that an initial key step in this process would be for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to organize a workshop on this topic. ICCVAM considered the nomination and supports with a high priority the concept of a workshop to discuss alternative methods and approaches that might reduce, refine, or replace the use of animals for botulinum potency testing. The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) considered the nomination and the ICCVAM proposal at its meeting on December 12, 2005, and agreed that the proposed activity should have a high priority. At this time, NICEATM requests (1) information on development and/or validation activities relevant to reduction, refinement (less pain and distress), and/or replacement alternatives for botulinum toxin potency testing, (2) public comments on the appropriateness and relative priority of proceeding with a workshop on this topic, (3) the nomination of scientific experts who might participate if a workshop occurs, and (4) the submission of data from mouse LD50 botulinum potency testing and ex vivo and in vitro test methods used for botulinum toxin potency testing. The HSUS nomination is available at https:// iccvam.niehs.nih.gov/ see ``Nominations and Submissions.''
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
Document Number: E6-1006
Type: Notice
Date: 2006-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Amendment of Notice
Document Number: E6-1003
Type: Notice
Date: 2006-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare Program; Payment for Respiratory Assist Devices With Bi-Level Capability and a Backup Rate
Document Number: 06-798
Type: Rule
Date: 2006-01-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule clarifies that respiratory assist devices with bi-level capability and a backup rate must be paid as capped rental items of durable medical equipment (DME) under the Medicare program and not paid as items requiring frequent and substantial servicing (FSS), as defined in section 1834(a)(3) of the Social Security Act. Before 1999, respiratory assist devices with bi-level capability (with or without a backup rate feature) were referred to as ``intermittent assist devices with continuous positive airway pressure devices'' under the Medicare program and in the Healthcare Common Procedure Coding System (HCPCS). This final rule responds to public comments received on a proposed rule published in the Federal Register on August 22, 2003, and finalizes the policy in that proposed rule. The rule will ensure that respiratory assist devices are consistently and properly paid under Medicare as capped rental items.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 06-780
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 06-779
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 06-778
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 06-777
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Disorders; Notice of Closed Meeting
Document Number: 06-776
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Disorders, Notice of Closed Meeting
Document Number: 06-775
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 06-774
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 06-773
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; Comment Request; Request for Generic Clearance To Conduct Voluntary Customer/Partner Surveys
Document Number: 06-772
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 06-771
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 06-770
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 06-749
Type: Notice
Date: 2006-01-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare and Medicaid Programs; Application by the TU
Document Number: 06-748
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This proposed notice acknowledges the receipt of an application from the TUV Healthcare Specialists for deeming authority for hospitals that wish to participate in the Medicare and 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; February 15, 2006 Town Hall Meeting on the Practice Expense Methodology Including the Proposal From the Physician Fee Schedule Proposed Rule for Calendar Year 2006
Document Number: 06-747
Type: Notice
Date: 2006-01-27
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This notice announces a Town Hall meeting on our methodology for establishing practice expense (PE) values for services paid under the physician fee schedule (PFS). The purpose of this meeting is to: (1) Clarify our proposed revisions to the PE methodology contained in the PFS calendar year (CY) 2006 proposed rule; and (2) receive comments and opinions from individuals of the medical community regarding ideas for the CY 2007 PFS proposed rule. This meeting is open to the public, but attendance is limited to space available.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 06-717
Type: Notice
Date: 2006-01-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2007: Proposed Annual Payment Rate Updates, Policy Changes, and Clarification
Document Number: 06-665
Type: Proposed Rule
Date: 2006-01-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed payment amounts and factors used to determine the updated Federal rates that are described in this proposed rule were determined based on the LTCH PPS rate year July 1, 2006 through June 30, 2007. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and would continue to be effective each October 1. The proposed outlier threshold for July 1, 2006, through June 30, 2007, would also be derived from the LTCH PPS rate year calculations. We are also proposing to make policy changes and clarifications.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 06-605
Type: Notice
Date: 2006-01-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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