Department of Health and Human Services January 2011 – Federal Register Recent Federal Regulation Documents

This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

HRSA will be issuing non-competitive supplemental grant funding to the University of Wisconsin, Laboratory of Hygiene, Madison, Wisconsin, under the Maternal Child and Health Bureau's Blood Lead Proficiency Testing Program. The University of Wisconsin will use these funds to initiate an orderly closeout of HRSA-funded activities which clearly fall within the purview of the Centers for Disease Control and Prevention's ``Preventing Lead Poisoning in Young Children'' initiative at their National Center for Environmental Health. This action will also accord the University of Wisconsin and the Center additional time to solicit recommendations from the CDC's Advisory Committee on Childhood Lead Poisoning Prevention with respect to future funding for this activity. The Maternal and Child Health Bureau (MCHB) has continuously supported the National Blood Lead and Erythrocyte Protoprophyrin (EP) Proficiency Testing Program through the University of Wisconsin since 1988. Childhood lead poisoning is a well-characterized public health problem in the U.S., and is unfortunately over-represented in minority, immigrant, and low socio-economic populations. The proper detection and treatment of lead poisoning relies entirely on the accurate and precise measurement of blood lead concentration. EP is utilized as an adjunct test to indicate the extent and duration of lead exposure, as well as the detection of iron deficiency, another pediatric health issue. Proficiency testing (PT) is a proven method for assuring and improving laboratory test accuracy. This program has cost-effectively provided monthly PT and other lab quality improvement tools to nearly 600 laboratories across the U.S. and beyond. Of note, the primary focus of the program over the last few years has been the integration of new and usually inexperienced participants into the program. An enrollment boom has been fueled by proliferation of the CLIA-waived LeadCare II point of care testing instrument. In the three years since its introduction, LeadCare II enrollment has grown from zero to 300 laboratories, comprising approximately 40 percent of all participants. Continued participation increases, and the fact that those increases are nearly totally comprised of LeadCare II users, represent both a public health success and a challenge for this program. Since its introduction in early 2007, over 300 of these laboratories have enrolled for PT, swelling program participation to 800 laboratories.

This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal FY (FY) 2009 and the preliminary Federal share DSH allotments for FY 2011. This notice also announces the final FY 2009 and the preliminary FY 2011 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.