Department of Health and Human Services September 25, 2009 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services, as requested by the Secretary, whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-November 18, 2009
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 18, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the quality of evidence surrounding the diagnosis and treatment of secondary lymphedema. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 11, 2009 (74 FR 6896). The document announced the withdrawal of approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs). The document published with an error in the identification of the ANDA for Amiodarone Hydrochloride Injection, 50 milligrams/ milliliter, held by Hospira, Inc. This document corrects that error.
Enforcement of General Tobacco Standard Special Rule for Cigarettes
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that as of the effective date identified in the FSPTCA, cigarettes that contain certain characterizing flavors are considered adulterated under the act. FDA is also providing in this notice contact information to which individuals who observe violative products after the effective date of the tobacco standard special rule may report their observations to FDA.
Medicare Program; Meeting of the Advisory Panel on Medicare Education, October 20, 2009
This notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Proposed Collection: Comment Request; 0MB No. 0925-0601/exp. 2/28/2010, “Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research”
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 Office of Extramural Research, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (0MB) for review and approval.
Medicare Program; Listening Session Regarding: Defining an Episode Logic for the Medicare Physician Resource Use Measurement Program; November 10, 2009
This notice announces a listening session being conducted as part of the proposal to further the Medicare program's ability to assess the relative resources used for beneficiary care using episodes of care as the unit of measurement. This listening session will solicit comments on the range of issues in the analysis of the applicability of currently available tools to identify discrete episodes of care for Medicare beneficiaries. Physicians, physician associations, and all other interested parties are invited to participate. The meeting is open to the public, but attendance is limited to space and teleconference lines available.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction
This document corrects technical errors that appeared in the final rule published in the Federal Register (74 FR 40288) on August 11, 2009 entitled, ''Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2010; Minimum Data Set, Version 3.0 for Skilled Nursing Facilities and Medicaid Nursing Facilities.''
Medicare and Medicaid Programs; Application by the American Osteopathic Association for Continued Deeming Authority for Ambulatory Surgical Centers
This final notice announces our decision to approve the American Osteopathic Association (AOA) for continued recognition as a national accreditation program for ambulatory surgical centers (ASCs) seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2010
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2010. The 2010 AIC threshold amounts are $130 for ALJ hearings and $1,260 for judicial review.
Medicare Program; Medicare Provider Feedback Group Town Hall Meeting-October 29, 2009
This notice announces the annual Medicare Provider Feedback Group (MPFG) Town Hall meeting. This meeting is open to all Medicare Fee-for-Service (FFS) providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, third-party billers, and interested parties, to present their individual views and opinions on selected FFS Medicare topics. In addition, we will be soliciting input on how we can improve communications to better serve the Medicare providers and suppliers.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April through June 2009
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2009 through June 2009, 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 and a list of Medicare- approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogragphy for dementia, and a list of Medicare-approved bariatric surgery facilities.
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