Department of Health and Human Services September 2007 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) will award a non-competitive successor grant to OMNI Institute, Inc., a non-profit research organization located in Denver, CO. OMNI Institute, Inc. will assume a grant awarded under the Head Start University Partnership Research Grants: Curriculum Development and Enhancement for Head Start and Early Head Start Programs for the remainder of the project period July 15, 2007 to September 29, 2008. This action is taken as the original grantee, the University of Colorado Health Sciences Center, has relinquished the grant.

This proposed rule would amend the regulatory definition of outpatient hospital services for the Medicaid program. Outpatient hospital services are a mandatory part of the standard Medicaid benefit package. The current regulatory definition at 42 CFR 440.20 is broader than the definition in Medicare, and can overlap with other covered benefit categories. The purpose of this amendment is to align the Medicaid definition more closely to the Medicare definition in order to improve the functionality of the applicable upper payment limits under 42 CFR 447.321 (which are based on a comparison to Medicare payments for the same services), provide more transparency in determining available coverage in any State, and generally clarify the scope of services for which Federal financial participation (FFP) is available under the outpatient hospital services benefit category.

In accordance with the Privacy Act of 1974, we are proposing to establish a new SOR, ``Post-Acute Care Payment Reform / Continuity of Assessment Record and Evaluation Demonstration and Evaluation (PAC- CARE),'' System No. 09-70-0569. Information maintained in this system will continue to enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care related costs in the Medicare program. Additionally, as required by Section 5008 of the Deficit Reduction Act of 2005, CMS is developing a comprehensive assessment for use at the time of hospital discharge which identifies the needs and clinical characteristics of the patient. Additionally, this standardized patient assessment instrument shall be used across post-acute care sites, including skilled nursing facilities, home health agencies, long term care hospitals and inpatient rehabilitation facilities, to measure functional status and other factors during treatment and at discharge from each provider. CMS proposes to broaden the scope of the disclosure requirement by adding a new routine use number 6, authorizing disclosure of personal health information to providers to facilitate the proper transfer of health information for beneficiaries being discharged from their site of care to an admitting provider's care. Individuals from the admitting providers will only be granted access to personal health information, if they have the approved, authenticated, role based authority to do so, and the need to know and review the admitted patient's personal health information. Individuals will only be granted access to this information if they meet the following requirements: they must (1) provide an attestation or other qualifying information that they are providing assistance to qualified acute care or post-acute care beneficiaries admitted to their care site, (2) have physically admitted the beneficiary to their site and have initiated an assessment of the beneficiary, (3) safeguard the confidentiality of the data and prevent unauthorized access, and (4) accept an on-line statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The routine uses will then be prioritized and reordered according to their usage. The primary purpose of this proposed system is to collect and maintain, and release when appropriate, demographic, health records, and health resource use related data on the target population of Medicare and potentially, Medicaid beneficiaries who require treatment by a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accreditation organizations; (6) permit the release of personal health information to complete a transfer-out (discharge) event and/or a transfer-in (admission) event; (7) support litigation involving the agency; and (8) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

This document corrects technical errors that appeared in the August 3, 2007 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2008; Final Rule.''

This proposed notice announces the receipt of an application from the Indian Health Service for continued recognition as a national accreditation organization for accrediting American Indian and Alaska Native entities that wish to furnish outpatient diabetes self- management training to Medicare beneficiaries. This notice also announces a 30-day public comment period.

This notice announces the annual Medicare Provider Feedback Group (MPFG) Town Hall meeting. This meeting is open to all Medicare fee-for-service (FFS) providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, other third-party billers and other interested parties, to present their individual views and opinions on selected FFS Medicare topics. In addition, we will be soliciting input on how we can improve communications to better serve the Medicare providers and suppliers. The meeting agenda and discussion materials will be available by October 12, 2007. The public can access these materials at https:// www.cms.hhs.gov/center/provider.asp. The feedback provided during this meeting will assist us as we evaluate FFS Medicare policy, operational issues and CMS' provider and supplier communication activities. The meeting is open to the public, but attendance is limited to space available. Registered participants from the meeting will be included in the Medicare Provider Feedback Group and may be contacted throughout the year for follow-up meetings to solicit additional opinions and clarify any issues that may arise from the October 16, 2007 meeting.

To support its objective of accelerating the diffusion and adoption of innovative health care delivery changes, the Agency for Healthcare Research and Quality (AHRQ) recently launched version 1.0 of the AHRQ Health Care Innovations Exchange (HCIE) Web site, https:// www.innovations.ahrq.gov. The HCIE is a new initiative designed to support health care professionals in sharing and adopting innovations that improve health care quality. Version 1.0 of the Web site is focused on stimulating creativity and innovation and will serve as a virtual place to which innovators will be encouraged to submit their innovations and experiences from which potential adopters can begin learning about the nuances of implementation. In Spring 2008, AHRQ will deploy version 2.0 of its Health Care Innovations Exchange site making hundreds of profiles of health care service innovations of varying degrees of novelty and scientific rigor accessible to the public. Version 2.0 will also offer expert commentary; stories; tools; lessons learned; ``change packages''sets of innovations implemented simultaneously; expanded content on implementation; and opportunities to learn and network. To build the database of innovations profiles, AHRQ invites submissions of health service innovations to its Health Care Innovations Exchange. The AHRQ Health Care Innovations Exchange database will cover the broad spectrum of health care settings, systems, and providers. Public health priority diseases/conditions, priority populations, and efforts to reduce disparities in quality will be highlighted. The AHRQ Health Care Innovations Exchange is seeking a broad range of novel health care strategies, activities, and tools. AHRQ invites participation in its Health Care Innovations Exchange by submitting descriptions of innovative efforts to improve the delivery of health care services.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials,'' dated September 2007. The guidance document provides sponsors of vaccine trials with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials. In particular, the guidance includes toxicity grading scale tables to use as a guideline for selecting the assessment criteria. The guidance announced in this notice finalizes the draft guidance of the same title dated April 2005.

The Department of Health and Human Services published a document in the Federal Register of July 17, 2007, Vol 72, No. 136, pages 39068 through 39069. The notice solicits nominations for appointment to the Advisory Committee on Minority Health. This notice is for the purpose of extending the period for nominations for an additional 45 days.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.'' The draft guidance explains, using a question and answer format, FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives.

The Food and Drug Administration is correcting a direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). That document amended the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. A proposal was published as a companion document to the direct final rule in the same issue of the Federal Register (August 16, 2007, 72 FR 45993). Both documents published with a typographical error in the codified section. This document corrects the error in the direct final rule. Elsewhere in this issue of the Federal Register we are correcting the error in the proposed rule.

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.

The Department of Health and Human Services published a document in the Federal Register of August 16, 2007, Vol. 72, No. 158, pages 46073 through 46082. The notice announced the sole source award of funds to provide Basic Medical Education Supportive of Maternal- Child Health at Kabul Medical University (KMU) and Clinical Training in Obstetrics and Gynecology to Resident Physicians and Refresher Training to Attending Physicians at the Rabia Balkhi Women's Hospital. This award is being withdrawn.

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