Department of Health and Human Services February 24, 2012 – Federal Register Recent Federal Regulation Documents
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Medicaid Program; Announcement of Medicaid Recovery Audit Contractors (RACs) Contingency Fee Update
This notice announces an increase to the maximum contingency fee, for which Federal financial participation (FFP) will be available, that may be paid to Medicaid Recovery Audit Contractors (RAC) by State Medicaid programs as authorized by section 1902(a)(42)(B) of the Social Security Act (the Act), as amended by the Affordable Care Act, requiring States to establish Medicaid RAC programs. In the September 16, 2011 Federal Register (76 FR 57808), we published a final rule that ties the Medicaid RAC contingency fee to the Medicare Recovery Audit Program with an opportunity for the States to request an exception to exceed the highest fee paid to a Medicare Recovery Auditor. Further, we indicated in the final rule that we would make States aware of any modifications to the payment methodology for contingency fee rates and Medicaid RAC maximum contingency fee rates by publishing a notice in the Federal Register. Therefore, this notice will inform States that Medicare has increased the maximum contingency fee paid to Recovery Auditors by 5 percent for the recovery of overpayments only for durable medical equipment claims (DME).
Proposed Collection; Comment Request; a Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Multi-Center International Hospital- Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type of Information Collection Request: Emergency. Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in the United States and in many other parts of the world. The contribution of environmental, occupational, and genetic factors to the cause of lymphoma has generated a series of novel findings from epidemiological studies conducted in the United States that have attempted to explain this increase. However, none of the chemical associations have been conclusively established and the identification of the key, functional alleles in gene regions associated with risk of NHL requires further elucidation. Further, the ability to follow-up, confirm, and extend these observations in the United States is limited by the low prevalence and limited range of several important chemical and viral exposures and the high to complete linkage disequilibrium among key candidate genetic loci in Western populations. To optimize the ability to build on and clarify these findings, it is necessary to investigate populations that differ from those in the West in both exposure patterns and underlying genetic structure. A multidisciplinary case- control study of lymphoma in Asia, where lymphoma rates have also risen, provides an opportunity to replicate and extend recent and novel observations made in studies in the West in a population that is distinctly different with regard to patterns of key risk factors, including range of exposures, prevalence of exposures, correlations between exposures, and variation in gene regions of particular interest. It will also improve the ability to understand the causes of certain types of rare lymphoma tumors in the United States that occur at much higher rates in Asia. As such, AsiaLymph will confirm and extend previous findings and yield novel insights into the causes of lymphoma in both Asia and in the United States. The major postulated risk factors for evaluation in this study are chemical exposures (i.e., organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other factors potentially related to lymphoma, such as viral infections, ultraviolet radiation exposure, medical conditions, and other lifestyle factors will also be studied. Patients from 19 participating hospitals will be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and lymphoma cases will be asked to make available a portion of their pathology sample. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Newly diagnosed patients with lymphoma or patients undergoing surgery or other treatment for non- cancer related medical issues who live in Taiwan and in Hong Kong, Chengdu and Tianjin, China will be enrolled at treating hospitals. The annual reporting burden is estimated at 5,302 hours (see Table below). There are $77,000 in Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Government-Owned Inventions; Availability for Licensing
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.
Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment of cUTIs, including clinical trial designs to support approval of drugs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey entitled ``Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities.'' The data collection will obtain knowledge of State and local capacities including food safety defense staffing and expertise, laboratory capacities, and information systems to support food and feed safety and defense.
Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the guidance.
Draft National Plan To Address Alzheimer's Disease
HHS is soliciting public input on the draft National Plan to Address Alzheimer's Disease, which is available at https://aspe.hhs.gov/ daltcp/napa/NatlPlan.shtml.
Medicare Program; Application by the American Association of Diabetes Educators (AADE) for Continued Recognition as a National Accreditation Organization for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training
This proposed notice announces the receipt of an application from the American Association of Diabetes Educators for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. The statute requires that we publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period.
Submission for OMB Review; Comment Request: STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science)
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on Oct 5, 2011 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science). Type of Information Collection Request: Extension of OMB number 0925-0616, expiration date 03/31/2012. Need and Use of Information Collection: The aim of STAR METRICS is twofold. The goal of STAR METRICS is to continue to provide mechanisms that will allow participating universities and Federal agencies with a reliable and consistent means to account for the number of scientists and staff that are on research institution payrolls, supported by federal funds. In subsequent generations of the program, it is hoped that STAR METRICS will allow for measurement of science impact on economic outcomes (such as job creatfon), on knowledge generation (such as citations, and patents) as well as on social and health outcomes. Frequency of Response: Quarterly.~ Affected Public: Universities and other research institutions. Type of Respondents: University administrators.
Request for Nominations of Children's Healthcare Quality Measures for Potential Inclusion in the CHIPRA 2013 Improved Core Set of Health Care Quality Measures for Medicaid/CHIP
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act to enact section 1139A (42 U.S.C.1320b-9a). Section 1139A(b) charged the Department of Health and Human Services (HHS) with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of measures of children's healthcare quality for potential inclusion in the CHIPRA 2013 Improved Core Set of Health Care Quality Measures (the ``Improved Core Set'') for potential voluntary use by Medicaid and the Children's Health Insurance Program. In addition, CHIPRA established the Pediatric Quality Measures Program to increase the portfolio of measures available to public and private purchasers of children's health care services, providers, and consumers. HHS anticipates that measures ultimately included in the Improved Core Set will also be used by public and private purchasers to measure pediatric healthcare quality. AHRQ is interested in information about the importance, scientific validity, and feasibility of the measures. If a measure is selected for inclusion, more information, including a copyright release (if applicable) and full measure specifications would be needed.
Availability of the Draft Supplementary Risk Assessment for the Boston University (BU) National Emerging Infectious Diseases Laboratories (NEIDL); Public Hearing
The National Institutes of Health has placed in the docket for public review and comment the Draft Supplementary Risk Assessment for the NEIDL, which is intended to respond to the concerns of the local community, courts, the National Research Council, and the general public regarding possible impacts of the laboratory. The purpose of the Draft Supplementary Risk Assessment for the NEIDL is to present the human health consequences of a potential accidental event or malevolent action resulting in the release of a pathogen or loss of biological containment at the NEIDL. Furthermore, this risk assessment compares the potential public health consequences resulting from the potential loss of biocontainment in a range of population density areas that represent urban, suburban, and rural environments. The urban, suburban, and rural sites that were selected for the purposes of the comparative analysis include the Boston University Medical Campus (BUMC) BioSquare Research Park, Boston, where the NEIDL has been constructed; the BU Corporate Education Center in Tyngsborough, Massachusetts; and the BU Sargent Center for Outdoor Education near Peterborough, New Hampshire. The Risk Assessment also examines whether locating the NEIDL in Boston would have a disproportionately high and adverse impacts on low-income and minority populations.
Patient Safety Organizations: Voluntary Relinquishment From UAB Health System Patient Safety Organization
AHRQ has accepted a notification of voluntary relinquishment from the UAB Health System Patient Safety Organization of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of 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 to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
Scientific Information Request on Treatment Strategies for Patients With Peripheral Artery Disease (PAD)
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of peripheral artery disease treatment medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Treatment Strategies for Patients with Peripheral Artery Disease (PAD), which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Scientific Information Request on Treatment of Atrial Fibrillation
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of atrial fibrillation medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of the Treatment of Atrial Fibrillation, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Scientific Information Request on Local Therapies for Unresectable Colorectal Cancer Metastases to the Liver
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of unresectable colorectal cancer medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Local Therapies for Unresectable Colorectal Cancer Metastases to the Liver, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
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: ``System Redesign for Value in Safety Net Hospitals and Delivery Systems.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Public Meetings in Calendar Year 2012 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2012 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
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