Department of Health and Human Services November 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 227
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2007 Through September 30, 2008
The Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Fiscal Year 2008 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2007 through September 30, 2008. This notice announces the calculated ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that we will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures, and Temporary Assistance for Needy Families (TANF) Contingency Funds, the federal share of Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. Programs under title XIX of the Act exist in each jurisdiction; programs under titles I, X, and XIV operate only in Guam and the Virgin Islands; while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. Programs under title XXI began operating in fiscal year 1998. The percentages in this notice apply to State expenditures for most medical services and medical insurance services, and assistance payments for certain social services. The statute provides separately for Federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Act require the Secretary of Health and Human Services to publish the Federal Medical Assistance Percentages each year. The Secretary is to calculate the percentages, using formulas in sections 1905(b) and 1101(a)(8)(B), from the Department of Commerce's statistics of average income per person in each State and for the Nation as a whole. The percentages are within the upper and lower limits given in section 1905(b) of the Act. The percentages to be applied to the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states. The ``Federal Medical Assistance Percentages'' are for Medicaid. Section 1905(b) of the Act specifies the formula for calculating Federal Medical Assistance Percentages as follows:
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Bertek Pharmaceuticals, Inc., to Mylan Bertek Pharmaceuticals, Inc.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Qualified Health Claims: Consumer Inferences About Monounsaturated Fatty Acids From Olive Oil, EPA and DHA Omega-3 Fatty Acids, and Green Tea
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Qualified Health Claims: Consumer Inferences About Monounsaturated Fatty Acids From Olive Oil, [eicosapentaenoic acid] EPA and [docosahexaenoic acid] DHA Omega-3 Fatty Acids, and Green Tea'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Guidance for Industry: Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Subjects for Delayed Adverse Events,'' dated November 2006. The guidance document provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Participants for Delayed Adverse Events,'' dated August 2005, and supplements the recommendations for study subject long-term follow-up in the ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors'' (Retroviral Vector guidance), dated November 2006.
Oral Dosage Form New Animal Drugs; Neomycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of neomycin sulfate oral solution in livestock for the treatment and control of bacterial enteritis.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this notice is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting on improving patient safety by enhancing the container labeling for parenteral infusion drug products. This will be a 1-day workshop involving FDA staff and representatives of the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The purpose of the meeting is to explore how labels on intravenous (IV) drug products could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label.
Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Availability; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period on the ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.'' The agency announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52800). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, the agency has decided to extend the comment period.
Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period on the draft guidance entitled ``Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.'' FDA announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52799). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the tenth 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).
Medicare Program; Notification of Hospital Discharge Appeal Rights
This final rule sets forth requirements for how hospitals must notify Medicare beneficiaries who are hospital inpatients about their hospital discharge rights. Notice is required both for original Medicare beneficiaries and for beneficiaries enrolled in Medicare Advantage (MA) plans and other Medicare health plans subject to the MA regulations. (For purposes of this preamble, these entities will collectively be known as ``Medicare health plans''). Hospitals will use a revised version of the Important Message from Medicare (IM), an existing statutorily required notice, to explain the discharge rights. Hospitals must issue the IM within 2 days of admission, and must obtain the signature of the beneficiary or his or her representative. Hospitals will also deliver a copy of the signed notice prior to discharge, but not more than 2 days before the discharge. For beneficiaries who request an appeal, the hospital will deliver a more detailed notice.
Medicare Program; Use of Repayment Plans
This proposed rule would modify Medicare regulations to implement a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules or ``ERS''). Under this provision, we propose to grant a provider or a supplier an extended repayment schedule under certain terms and conditions as defined in the statute. The proposed rule would establish criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.''
Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations
In this rule, we finalize changes to four of the current requirements (or conditions of participation (CoPs)) that hospitals must meet to participate in the Medicare and Medicaid programs. Specifically, this final rule revises and updates our CoP requirements for: Completion of the history and physical examination in the medical staff and the medical record services CoPs; authentication of verbal orders in the nursing service and the medical record services CoPs; securing medications in the pharmaceutical services CoP; and completion of the postanesthesia evaluation in the anesthesia services CoP. We also respond to timely public comments submitted on the proposed rule published in the March 25, 2005 Federal Register (70 FR 15266). The changes specified in this final rule are consistent with current medical practice and will reduce the regulatory burden on hospitals.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: James C. Lin, Ph.D., University of Illinois at Chicago: Based on the findings from an inquiry by the University of Illinois at Chicago (UIC) and on additional analysis conducted by ORI during its oversight review, the U.S. Public Health Service (PHS) found that James C. Lin, Ph.D., Professor, Department of Electrical and Computer Engineering, Physiology, and Biophysics, UIC, engaged in research misconduct concerning National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant application 1 R01 NS47238-01, ``Blood-Brain Barrier Interactions of Cellular-Phone Radi.'' Specifically, PHS found that Dr. Lin committed research misconduct relative to the legend and related text for Figure 2 (data from a colleague on other experiments) for his NIH application 1 R01 NS47238- 01, by falsely claiming the figure represented preliminary results of his independent experiments that differed from the source of the figure and the prior research in the field, in which he purported to have selectively exposed the rat's head to microwave irradiation, to have utilized higher peak exposure, of shorter duration and of different radio frequencies, and which reported injury of more acute nature to the blood barrier. Dr. Lin denies all allegations of research misconduct and contends that some of his original data is missing as a result of the involuntary relocation of his laboratory. Dr. Lin makes no admission of guilt in connection with the charges or PHS' findings of research misconduct herein. Both Dr. Lin and PHS are desirous of concluding this matter without further expense of time and other resources. Dr. Lin has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on October 24, 2006: (1) That any institution which submits an application for PHS support for a research project on which Dr. Lin's participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS-funded research in which Dr. Lin is involved, must concurrently submit a plan for supervision of Dr. Lin's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of his research contribution. Dr. Lin agrees to ensure that a copy of the supervisory plan also is submitted to ORI by the institution. He also agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; (2) that any institution employing Dr. Lin submit in conjunction with each application for PHS funds or reports, manuscripts, or abstracts of PHS-funded research in which Dr. Lin is involved a certification that the data provided by Dr. Lin are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report. Dr. Lin must ensure that the institution also sends a copy of the certification to ORI; and (3) to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Findings of Misconduct in Science
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Clifford R. Robinson, Ph.D., University of Delaware: Based on the reports of investigations conducted by 3-Dimensional Pharmaceuticals, Inc. (3DP) and the University of Delaware (UD) and additional analysis conducted by ORI during its oversight review, the U.S. Public Health Service (PHS) found that Clifford R. Robinson, Ph.D., Assistant Professor, Department of Chemistry and Biochemistry, UD, engaged in misconduct in science involving research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants 1 R43 GM58950-01 and 2 R44 GM58950-02, ``Four- helix bundle analog of a G-protein coupled receptor (C. Robinson, Principal Investigator [P.I.]). The following grant applications also were involved in Dr. Robinson's misconduct in science: 1 R43 GM62708-01, ``Improved method for protein refolding'' (C.R. Robinson, P.I.), submitted March 30, 2000; approved but not funded, withdrawn. 1 P20 RR017716-01, ``Design of hierarchical recognition motifs,'' Project V, ``Determinants of stability and assembly of integral membrane proteins'' (C.R. Robinson, Project Investigator), submitted March 1, 2002, funded September 16, 2002, to August 30, 2007. 1 R01 GM074789-01, ``Folding and stability of integral membrane proteins'' (C.R. Robinson, P.I.), submitted October 1, 2004; scored not competitive, not funded. 1 R01 GM075891-01, ``Membrane protein expression, solubilization, and refolding'' (C.R. Robinson, P.I.), submitted January 24, 2005; approved but not funded, pending. 1 R21 GM07953-01, ``Mini-receptor analogs of GPCRs'' (C.R. Robinson, P.I.), submitted January 25, 2005; not funded. Specifically, PHS found that Dr. Robinson engaged in the following acts of misconduct in science. With regard to the following paragraphs numbered 1-6, nothing herein shall be deemed as an admission of liability on the part of Dr. Robinson. 1. While at 3DP, Dr. Robinson systematically substituted crystallized chicken ovalbumin in place of [beta]2-AR-NQ and repeatedly provided these crystalline preparations to other scientists to conduct molecular analyses. Dr. Robinson made false claims about his progress on characterizing [beta]2-AR-NQ and falsely claimed to have supplied purified [beta]2-AR-NQ to 3DP staff in project team meetings (PTM) held on at least five occasions between July 14, 1998, and July 7, 1999. 2. Dr. Robinson made multiple false claims about his research on [beta]2-AR-NQ in NIH grant applications R44 GM58950-02, submitted April 1, 1999, supplemental material for the same application submitted on July 7, 1999, and NIH grant application R43 GM62708-01, submitted March 30, 2000. 3. Dr. Robinson made similar claims as in item 1 above concerning the wild type form of [beta]2-AR, by substituting canine ovalbumin. Dr. Robinson's false claims were made to 3DP staff at PTM meetings on at least three occasions between September 7, 1999, and March 30, 2000, and in NIH grant application R43 GM62708-01, and after moving to UD, in NIH grant application 1 P20 RR017716-01, submitted on March 1, 2002. 4. Dr. Robinson was unable to adequately produce recombinant [beta]2-AR in E. coli and made false claims at PTM meetings in September and October 1999 that he had successfully expressed active protein and had purified it for crystallization trials. Dr. Robinson also made false claims in NIH grant applications R43 GM62708-01 and 1 R01 GM07589-01, submitted January 24, 2005, that he had purified large amounts of [beta]2-AR-NQ from E. coli and that he had reconstituted the protein into its native biologically active form. 5. Dr. Robinson made false claims about his ability to produce, purify, and characterize a recombinant fragment of [beta]2- AR-NQ containing four transmembrane domains ([beta]2-AR-4HB) at PTM meetings in October 1998 and in NIH grant applications R44 GM58950-02 and 1 P20 RR017716-01. 6. Dr. Robinson falsified fluorescence spectra and circular dichroism measurements in Figure 7 (both left and right panels) of NIH grant application R44 GM58950-02 by substituting results obtained with different proteins. 7. After moving to UD, Dr. Robinson made false claims in NIH grant application 1 P20 RR017716-01, including presenting falsified data in both panels of Figures V.5 (fluorescence spectra and circular dichroism measurements) and V.9 (falsified experimental conditions). 8. While at UD, Dr. Robinson falsified circular dichroism and fluorescence data in NIH grant application 1 R01 GM074789-01 (Figures 5A, 5B, and 6) and circular dichroism data in NIH grant applications 1 R01 GM075891-01 (Figure 6) and 1 R21 GM075953-01 (Figure 5). 9. In presentations at the Biophysical Society annual meeting and a Cornell University Consortium meeting, both in 1999, Dr. Robinson falsely represented data obtained with cytochrome b562 as being obtained with [beta]2-AR. Dr. Robinson has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed, for a period of five (5) years, beginning on October 23, 2006: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR Part 76; and (2) to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers; Decorative, Non-Corrective Contact Lenses; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non- Corrective Contact Lenses.'' This guidance document explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). All contact lenses, including decorative, non-corrective contact lenses, require premarket approval or clearance by FDA and may be dispensed only upon a lawful prescription order by an eye care professional. Although this guidance document is being immediately implemented, the agency welcomes comments at any time in accordance with the agency's good guidance practices (GGPs).
Food Defense Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants). Date and Time: This public workshop will be held on March 29, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St., Dallas, TX 75215. Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, Suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: david.arvelo@fda.hhs.gov. Registration: Registration by March 15, 2007, is encouraged. The RMSBDC has a $20 registration fee to cover the cost of facilities and refreshments. Please submit your registration as soon as possible. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $25, payable to RMSBDC. If you need special accommodations due to a disability, please contact David Arvelo (see the Contact section of this document) at least 7 days in advance. Registration Form Instructions: To register, please complete the RMSBDC registration form and submit along with payment to RMSBDC, Attn: Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the completed registration form to RMSBDC at 214-860-5867. To obtain a copy of the registration form, please call RMSBDC at 214-860-5887 or 214- 860-5849. The registration form is also available online at https:// www.ntsbdc.org/. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Workshop handouts may be requested through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.
Availability of Final Toxicological Profiles
This notice announces the availability of one new and five updated final toxicological profiles of priority hazardous substances comprising the eighteenth set prepared by ATSDR.
Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum Level and Enforcement Policy, Availability; and Supporting Document: Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum level and Enforcement Policy,'' and a supporting document entitled ``Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children.'' The guidance provides a maximum recommended lead level in candy likely to be consumed frequently by small children. FDA considers the recommended maximum level to be protective of human health and to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients. The guidance states FDA's commitment to take enforcement action against candy containing lead at levels that may pose a health risk. These two documents are intended to assist candy manufacturers in achieving reduced lead levels in their products consistent with the agency's policy of reducing lead levels in the food supply to reduce consumers' lead exposure to the lowest level that can practicably be obtained.
National Institute of Environmental Health Sciences (NIEHS); Workshop: Children's Environmental Health: Past, Present and Future Research Strategies
On January 22-23, 2007, the NIEHS is hosting a workshop titled ``Children's Environmental Health Research: Past, Present, and Future.'' The goal of this workshop is to develop new strategies for research, exposure and effects monitoring, intervention and prevention in children's environmental health. Specific objectives are to maximize the effectiveness of scientific researchbasic science, exposure monitoring/biomonitoring, epidemiology, toxicology, clinical medicine and multidisciplinary studiesand to enhance the translation of research to the bedside, to the community and to public policy. This meeting is open to the public with attendance limited only by the space available. Time will be set aside for public discussion. Additional information about the workshop and on-line registration are available from the NIEHS Web site at https://www.apps.niehs.nih.gov/conferences/ od/cehr/. The first day will begin with discussions of two case studies that demonstrate the successful implementation of evidence-based intervention/prevention strategies that became possible once links between environmental exposures and a disease in children had been identified. The first case study will focus on lead and neurotoxicity. Findings on the adverse effects of lead on neurodevelopment ultimately led to efforts to reduce exposures to lead. Asthma will be used as a second case study because it provides a clear example of environmental triggers and some science-based prevention/intervention strategies that are already being implemented. The second day of the workshop will focus on applying lessons learned from the two ``success'' case studies to two children's disorders that appear to have environmental etiologies but are less well understood: disorders of lipid and carbohydrate metabolism and attention deficit/hyperactivity disorder (ADHD). A discussion will follow each case study presentation to consider the opportunities, the barriers and the design challenges that confront future clinical, toxicological, epidemiological, exposure monitoring, and basic research in children's environmental health. Specific topics include: Past approaches to research translation to see what worked and what failed to work. The critical mass of researchers and mix of disciplines needed to most efficiently advance research in children's environmental health. Biomarkers of exposure, susceptibility, or subclinical dysfunction. The use of ``omics'' technologies that might be incorporated into future toxicological, epidemiological and/or biomonitoring studies to enhance their sensitivity and efficiency. Is there a point at which the use of new scientific tools might slow the pace of progress? New approaches to accelerating the translation of science to treatment, prevention, and the remediation of environmental risks to children's health. Potential study populations at uniquely high risk of disease. Data resourcesrecords, disease registries, well- characterized cohort populations, tissue banks, or stored DNAin the U.S. or abroad that might facilitate future studies. New partnerships in research.
Medicare Program; Listening Session on a Plan for Medicare Hospital Value-Based Purchasing-January 17, 2007
This notice announces a listening session being conducted as part of the development of a plan for Medicare hospital value-based purchasing, as authorized by the section 5001(b) of the Deficit Reduction Act (DRA) of 2005. The purpose of the listening session is to solicit comments on the range of design issues being considered for plan development. Hospitals, hospital associations, and all interested parties are invited to attend and make comments in person. It will also be possible to participate by teleconference, although due to time constraints, telephone participants will not be able to make verbal comments. Written comments are welcomed. The perspectives expressed during this session and in writing will assist us in drafting the plan. An issues paper outlining the design questions to be discussed and further information about the January listening session will be posted no later than January 3, 2007 on the CMS Web site, Hospital Center, under Spotlights at https://www.cms.hhs.gov/center/hospital.asp.
Medicare Program; Decisions Affecting Medicare Advantage Plans Deemed by Joint Commission for the Accreditation of Health Care Organizations
This notice announces our decisions regarding deemed status of Joint Commission for the Accreditation of Health Care Organization- accredited Medicare Advantage plans. These decisions follow business decisions made by Joint Commission for the Accreditation of Health Care Organization in late 2005 which affect its deeming operations beginning January 1, 2006 and continue until Joint Commission for the Accreditation of Health Care Organization's deeming authority expires on March 24, 2008.
Medicare Program; Rechartering of the Advisory Panel on Ambulatory Payment Classification Groups
This notice announces the rechartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) by the Secretary of DHHS (the Secretary) for a 2-year period with the new Charter effective until November 21, 2008.
Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups
This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). One vacancy presently exists on the Panel due to a Panel member's retirement in June 2006. There will be six more vacancies on the Panel between January 1 and September 30, 2007. Consequently, this solicitation is for seven new members. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as we prepare our annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking. The Secretary rechartered the Panel in 2004 for a 2-year period through November 21, 2006. The new Panel Charter will be effective through November 21, 2008. Nominations: We will consider nominations if they are received no later than 5 p.m. on December 18, 2006. Please mail or deliver nominations to the following address: CMS; Attn: Shirl Ackerman-Ross, Designated Federal Official (DFO), Advisory Panel on APC Groups; Center for Medicare Management, Hospital & Ambulatory Policy Group, Division of Outpatient Care; 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. Web Site: For additional information on the APC Panel and updates to the Panel's activities, search our Web site at the following: http:/ /www.cms.[fxsp0]hhs.gov/FACA/05 [fxsp0]AdvisoryPanelonAmbulatory[fxsp0]PaymentClassificationG roups.[fxsp 0]asp#TopOfPage. Advisory Committees' Information Lines: You may also refer to the CMS Federal Advisory Committee Hotlines at 1-877-449-5659 (toll-free) or 410-786-9379 (local) for additional information.
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