Department of Health and Human Services April 2009 – Federal Register Recent Federal Regulation Documents

Following the Senate Appropriations Committee's recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2009 competition to current and former Healthy Start grantees with expiring or recently expired project periods.

This document is guidance and a request for comments under section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5). ARRA was enacted on February 17, 2009. The HITECH Act (the Act) at section 13402 requires the Department of Health and Human Services (HHS) to issue interim final regulations within 180 days of enactment to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide for notification in the case of breaches of unsecured protected health information. For purposes of these requirements, section 13402(h) of the Act defines ``unsecured protected health information'' to mean protected health information that is not secured through the use of a technology or methodology specified by the Secretary in guidance, and requires the Secretary to issue such guidance no later than 60 days after enactment and to specify within the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Through this document, HHS is issuing the required guidance and seeking public comment both on the guidance as well as the breach notification provisions of the Act generally to inform the future rulemaking and updates to the guidance.

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2009, for the final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ``Substances Prohibited From Use in Animal Food or Feed.'' The agency is also establishing a compliance date of October 26, 2009, for this rule in order to allow additional time for renderers to comply with the new requirements. This additional time will also give other affected persons, including cattle producers and packers, more time to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule.

This proposed rule would set forth the hospice wage index for fiscal year 2010. The proposed rule would adopt a MedPAC recommendation regarding a process for certification and recertification of terminal illness. This proposed rule would also continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), which will conclude in 2011. In addition, we are requesting comments on a suggestion to require recertification visits by physicians or advanced practice nurses, and on issues of payment reform for use in possible future policy development. Finally, the proposed rule would make several technical and clarifying changes to the regulatory text.

The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement award of Part C Early Intervention Services funds under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006, to the Reading Hospital for services previously provided by the St. Joseph Medical Center in order to ensure continuity of critical HIV medical care and treatment services and to avoid a disruption of HIV clinical care to clients in the city of Reading, Pennsylvania, and all of Berks and Schuylkill Counties.

This notice announces changes made by the Genetic Information Nondiscrimination Act of 2008 (GINA) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) to section 1882 of the Social Security Act (the Act), which governs Medicare supplemental insurance. This notice also recognizes that the Model Regulation adopted by the National Association of Insurance Commissioners (NAIC) on September 24, 2008, is considered to be the applicable NAIC Model Regulation for purposes of section 1882 of the Act, subject to our clarifications that are set forth in this notice.

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: ``Building an Implementation Toolset for E-Prescribing.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

This correcting amendment corrects a technical error in the regulations text in the final rule published in the Federal Register on December 19, 2008 (73 FR 77904) entitled, ``Disproportionate Share Hospital Payments.'' In that final rule, we set forth data elements necessary to comply with the requirements of section 1923(j) of the Social Security Act (the Act) related to auditing and reporting of disproportionate share hospital payments under State Medicaid programs. The effective date was January 19, 2009.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines).

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.