Department of Health and Human Services July 23, 2010 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Solicitation for Proposals for the Medicare Imaging Demonstration
This notice informs interested parties (here in there after referred to as conveners) of an opportunity to apply to participate in the Medicare Imaging Demonstration (MID) that was authorized by section 135(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The goal of the MID is to collect data regarding physician compliance with appropriateness criteria selected by the Secretary under the terms of the statute in order to determine the appropriateness of advanced diagnostic imaging services furnished to Medicare beneficiaries.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Voluntary Registration by Authorized Officials of Non-Covered Retail Food Establishments and Vending Machine Operators Electing To Be Subject to the Menu and Vending Machine Labeling Requirements Established by the Patient Protection and Affordable Care Act of 2010
Section 4205 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) established requirements for nutrition labeling of standard menu items for restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items (hereinafter ``chain retail food establishments''), and for certain foods sold in vending machines operated by an operator that owns or operates 20 or more vending machines (hereinafter ``chain vending machine operators''). Under the Affordable Care Act, retail food establishments and vending machine operators not covered by section 4205 of the Affordable Care Act may elect to become subject to its requirements by registering biannually with FDA. Congress required that, within 120 days of enactment of the Affordable Care Act (March 23, 2010), FDA issue a Federal Register notice specifying the terms and conditions for implementation of voluntary registration, pending promulgation of regulations. FDA is issuing this notice to assist restaurants and similar retail food establishments and vending machine operators that are not subject to the menu labeling requirements of section 4205 of the Affordable Care Act, but choose to register to become subject to them, in voluntarily registering with FDA, pending promulgation of regulations.
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 14, 2010 (75 FR 40843). The document announced the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.'' The document was published with an incorrect docket number. This document corrects that error.
Transport of Laboratory Personnel Potentially Exposed to Infectious Agents From Fort Detrick, Frederick, MD to the National Institutes of Health Clinical Research Center, Bethesda, MD; (NIH Transportation EIS); Record of Decision
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services (DHHS), has decided, after completion of a Final NIH Transportation EIS and a thorough consideration of the public comments on the Draft NIH Transportation EIS, to implement the Proposed Action, which was identified as the Preferred Alternative in both the Draft EIS and the FEIS. This action involves the transport of laboratory personnel suspected of having potential occupational exposure to infectious agents under study at the NIBC located at Fort Detrick, Maryland, to the Special Clinical Studies Unit at the NIH Bethesda, Maryland Campus for observation and, if necessary, treatment.
Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and Appeals and External Review Processes Under the Patient Protection and Affordable Care Act
This document contains interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. The regulations will generally affect health insurance issuers; group health plans; and participants, beneficiaries, and enrollees in health insurance coverage and in group health plans. The regulations provide plans and issuers with guidance necessary to comply with the law.
Request for Public Comment and Consultation Meetings on the Adoption and Foster Care Analysis and Reporting System (AFCARS)
Section 479 of the Social Security Act (the Act) requires that the Administration for Children and Families (ACF) develop and write regulations to implement a system for the collection by title IV-E agencies of data relating to adoption and foster care. The resultant Adoption and Foster Care Analysis and Reporting System (AFCARS) has been operating since 1994 and is administered by the Children's Bureau (CB) in ACF. AFCARS collects case level information on all children in foster care for whom the title IV-E agency has responsibility for placement and care and on children adopted under the auspices of the title IV-E agency. We issued a Notice of Proposed Rulemaking (NPRM) on January 11, 2008 (73 FR 2082) that proposed to amend the AFCARS regulations at 45 CFR 1355.40 and the appendices to part 1355 [https:// edocket.access.gpo.gov/2008/E7-24860.htm]. The proposal would modify the requirements for title IV-E agencies to collect and report data to ACF on children in out-of-home care and in subsidized adoption or guardianship arrangements with the title IV-E agency. Due to the enactment of the Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) and the substantial changes it introduced in title IV-E, we intend to issue a new AFCARS NPRM. To inform development of the new NPRM we request that interested parties comment on the questions below.
Request for Public Comment Concerning the Redesign of Statewide Automated Child Welfare Information System (SACWIS) Requirements
Sections 474(a)(3)(C) and (D) of the Social Security Act (the Act) provide States with the opportunity to access additional funding through title IV-E to plan, design, develop, implement, and operate a Statewide Automated Child Welfare Information System (SACWIS). The regulations at 45 CFR 1355.50-1355.57 were established in response to this legislation and were issued on December 22, 1993.
Maternal, Infant, and Early Childhood Home Visiting Program
The Health Resources and Services Administration and Administration for Children and Families, HHS, solicit comments by August 17, 2010 on proposed criteria for evidence of effectiveness of home visiting program models for pregnant women, expectant fathers, and primary caregivers of children birth through kindergarten entry. Final criteria for evidence of effectiveness will be included in the program announcement inviting eligible entities to apply for funding under the Affordable Care Act Maternal, Infant, and Early Childhood Home Visiting Program.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Service Provider Study
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. This collection of information relates to the Area Agency on Aging and Local Service Provider Study.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Reduction of Clostridium difficile Infections in a Regional Collaborative of Inpatient Healthcare Settings through Implementation of Antimicrobial Stewardship.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices
This proposed rule would set forth an update to the Home Health Prospective Payment System (HH PPS) rates, including: The national standardized 60-day episode rates, the national per-visit rates, the non-routine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) add-on payment amounts, under the Medicare prospective payment system for HHAs effective January 1, 2011. This rule also proposes to update the wage index used under the HH PPS and, in accordance with The Affordable Care Act of 2010 (The Affordable Care Act), Public Law 111-148, to update the HH PPS outlier policy. In addition, this rule proposes changes to the home health agency (HHA) capitalization requirements. This rule further proposes to add clarifying language to the ``skilled services'' section. Finally, this rule incorporates new legislative requirements regarding face-to-face encounters with providers related to home health and hospice care.
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