Department of Health and Human Services July 20, 2012 – Federal Register Recent Federal Regulation Documents

This final rule establishes data collection standards necessary to implement aspects of section 1302 of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. This final rule also establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans.

This notice seeks comments on proposed changes in the State Title V Maternal and Child Health (MCH) Block Grant allocations. Through the Health Resources and Services Administration's Maternal and Child Health Bureau (MCHB), Title V MCH Block Grant funds are allocated to States based in part on a calculation of the number of children living in poverty (in an individual State) as compared to the total number of children living in poverty in the United States, using data for the number of children in poverty in each State from the U.S. Census Bureau's official decennial census. As the Census Bureau has replaced the decennial census long-form sample questionnaire with the American Community Survey (ACS), MCHB likewise plans to use the ACS as its source for this data. The ACS offers broad, comprehensive information on social, economic, and housing data and is designed to provide this information at many levels of geography. ACS child poverty estimates are produced annually and will allow the Block Grant allocation proportions to be updated more frequently than every 10 years. The Census Bureau produces annual State-level poverty estimates based on the most recent 1, 3, and 5 years of ACS data as well as annual model-based Small Area Income and Poverty Estimates (SAIPE). It is proposed that MCHB implement annual changes to the State Title V MCH Block Grant allocations using the 3-year ACS poverty estimates, wherein each annual change is buffered by sharing 2 of 3 data years in a 3-year rolling period estimate.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41,42 U.S.C. 299b-21-b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the Coalition for Quality and Patient Safety of Chicagoland (CQPS PSO) of its status as a PSO, and has delisted the PSO accordingly.

As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PSOs). The purpose of this notice is to announce the availability of a new Common FormatReadmissions Version 0.1 Beta for public review and comment.