Antibiotic use and resistance data reporting to CDC’s National Healthcare Safety Network included in proposed Meaningful Use Stage 3
miércoles, 1 de abril de 2015
Revised Federal Guidelines for Opioid Treatment Programs
Revised Federal Guidelines for Opioid Treatment Programs
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Revised Federal Guidelines for Opioid Treatment Programs Dear Colleagues, The revised Federal Guidelines for Opioid Treatment Programs, published by SAMHSA, are now available. SAMHSA periodically revises the guidelines to reflect best practices based on current evidence and changes in health care delivery. The revised Federal Guidelines for Opioid Treatment Programs contain updated information on patient assessment and treatment planning, overdose prevention and relapse prevention, and patient-centered, integrated, and recovery-oriented care. Guidance is provided on the use of telemedicine and the role of various health professionals in opioid treatment programs (OTP). The revised guidelines should be the primary reference and central measure for program staff, accreditation bodies, and other stakeholders on the delivery of care in OTPs that is both high quality and in compliance with federal regulations. However, these guidelines are not a substitute for medical judgment and cannot provide the sole basis for treatment decisions. Program staff should keep in mind that some states apply additional regulations to OTP operations and should verify that they are in compliance with state and federal regulations, or the stricter of the two if they conflict. For further information and questions, please contact Melinda Campopiano, M.D., Branch Chief at SAMHSA. You may call her directly at 240-276-2701 or email her atmelinda.campopiano@samhsa.hhs. Sincerely, Daryl W. Kade Acting Director Center for Substance Abuse Treatment |
NHLBI Funding & Research Opportunities and Announcements for March 31, 2015
Funding and Research Opportunities
The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:
Notices:
Request for Information (RFI): NHLBI Strategic Visioning - Developing the Research Priorities for the Next Decade
(NOT-HL-15-252)National Heart, Lung, and Blood Institute
(NOT-HL-15-252)National Heart, Lung, and Blood Institute
Notice of Change to Award Information Regarding Allowable Requested Direct Costs in PAR-13-316 "NHLBI Program Project Applications (P01)"
(NOT-HL-15-256)National Heart, Lung, and Blood Institute
(NOT-HL-15-256)National Heart, Lung, and Blood Institute
Notice of National Heart, Lung, and Blood Institute (NHLBI) Participation in PAR-15-085 "Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental and Clinical Research (U01)"
(NOT-HL-15-257)National Heart, Lung, and Blood Institute
(NOT-HL-15-257)National Heart, Lung, and Blood Institute
Requests for Applications:
Genome Sequencing Program Coordinating Center (U24)
(RFA-HG-15-019)National Human Genome Research InstituteApplication Receipt Date(s): May 29, 2015
(RFA-HG-15-019)National Human Genome Research InstituteApplication Receipt Date(s): May 29, 2015
Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date.Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using theFedBizOpps search function. Under “Document to Search,” select Archived Documents.
April 2015 CMS National Training Program Update
CMS Adds Star Ratings to Hospital Compare
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Webinars to Grow Your Knowledge
Monthly Update Webinar
April 7, 2015
Each month we offer a webinar featuring subject matter experts who share information on current topics to keep you up-to-date. This month we’ll talk about the Nursing Home Compare 5-Star Quality Rating System and Medicare’s new Preventive Services.
Join the audio portion of the webinar on 1-800-603-1774, conference ID: 43258288 and join the webinar athttps://webinar.cms.hhs.gov/
Medicare Learning Series – Medicare’s Blue Button, Electronic Health Records, & Preventive Services
April 9, 2015 1:00 – 2:30 pm ET
Join the CMS National Training Team as we share an overview of electronic health records and a demonstration of Medicare’s Blue Button. We’ll also have an in-depth discussion on Medicare’s new preventive services.
New CMS Publications |
EHC Program Update: White Paper; Free CME/CE Activities; Methods Research Webinar
EHC Program Update: White Paper; Free CME/CE Activities; Methods Research Webinar
The following have been posted to the EHC Program Web site:
Final Report
Comparison of Effects as Evidence Evolves From Single Trials to High-Quality Bodies of Evidence. To access this report, visit:http://www.
CME/CE Activities
These free CME/CE activities have been developed from EHC Program Evidence Reports:
- Medication Adherence Interventions: Comparative Effectiveness. To access this activity, visit:http://ahrq.cmeuniversity.com/
course/disclaimer/111001. - The Patient-Centered Medical Home, A Resource Evaluating the Comprehensive PCMH Model. To access this activity, visit: http://ahrq.cmeuniversity.com/
course/disclaimer/111046.
The EHC Program offers more than 67 free CME/CE activities developed from systematic reviews of evidence on high-priority health conditions and methods research. To access all CME/CE activities currently available for participation, visit: http://www.
Research Methods Webinar on Determining the Pragmatic Characteristics of Research
The Agency for Healthcare Research and Quality is hosting a free webinar on Friday, May 1st from 1:30 pm-3:00 pm EST. This presentation, based on the Implementation Science article, "How pragmatic is it? Lessons learned using PRECIS and RE-AIM for determining pragmatic characteristics of research," will provide an in-depth overview of two methodologies used to rigorously evaluate and identify pragmatic trials. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works under optimal situations.
The methodologies, RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and PRECIS (Pragmatic-Explanatory Continuum Indicator Summary ) can help explain findings to inform researchers’ determination of whether an intervention or policy is appropriate for their setting.
Application for CME credit has been filed with the American Academy of Family Physicians. Determination of credit is pending.
Presenter: Bridget Gaglio, PhD, Program Officer – Communication and Dissemination Research at Patient-Centered Outcomes Research Institute (PCORI)
Moderator: Rebecca Roper, MS, MPH, Director, Practice-Based Research Network Initiative, Agency for Healthcare Research and Quality.
To register for the webinar, visit: https://attendee.gotowebinar.
To access the article, go to: http://www.
Effective Health Care Programhttp://effectivehealthcare.
EHC Program Update: White Paper; Free CME/CE Activities; Methods Research Webinar
Dra. Marisa Aizenberg: En abril entra en vigencia la ley de cobertura al paciente ostomizado
Dra. Marisa Aizenberg: En abril entra en vigencia la ley de cobertura al paciente ostomizado
La ley fue una iniciativa de la legisladora cordobesa del Frente para la Victoria Nora Bedano y fue bien recibida por la Asociacion Argentina de Ostomizados, que en un comunicado manifestó que se trata de una medida crucial para los pacientes que sufren esta dolencia.
Posted: 31 Mar 2015 06:00 AM PDT
Desde el 9 de abril los pacientes ostomizados que necesitan elementos para su tratamiento tendrán una cobertura integral, ya que comienza a regir la ley promulgada por el Poder Ejecutivo.
La ley fue una iniciativa de la legisladora cordobesa del Frente para la Victoria Nora Bedano y fue bien recibida por la Asociacion Argentina de Ostomizados, que en un comunicado manifestó que se trata de una medida crucial para los pacientes que sufren esta dolencia.Según se detalló, la norma incorpora al Programa Médico Obligatorio (PMO) la cobertura total de los dispositivos (bolsas) y los elementos accesorios en la cantidad que necesiten según prescripción médica, asegurando un tratamiento correcto y de calidad.
Un paciente ostomizado es aquel que ha sido objeto de una intervención quirúrgica para obtener una derivación fisiológica que aboca al exterior en un punto diferente al orificio natural, lo que conlleva alteraciones biológicas (cambios higiénicos, dietéticos, pérdida de control de esfínteres), psicológicos (afectación de la propia imagen, autoestima) y sociales (dificultad de integración y reinserción), como consecuencia de las anteriores modificaciones.
Los beneficios de esta ley alcanzan a todos los pacientes que hayan sido sometidos a una intervención de este tipo, ya sea de manera temporal o permanente y tengan o no cobertura de salud.
Además de las bolsas y demás elementos, la ley reconoce y asegura el derecho de los ostomizados de contar con un equipo interdisciplinario que garantice su total rehabilitación y reinserción en la vida social.
La norma también prevé el desarrollo de guías en las que se especifiquen los cuidados clínicos necesarios, así como los hábitos saludables para el tratamiento de estos pacientes.
La Ley recibió sanción definitiva el 10 de diciembre de 2014 por parte del Senado Nacional y fue promulgada de hecho el 9 de enero del presente año, comenzando a regir, según lo explicita su texto, 90 días después de esa fecha.
"Estamos muy agradecidos y recibimos esta ley con mucha alegría", indicó Luis Michelengeli, un ostomizado de 66 años, al referirse a la norma.
"Sólo esperamos y pedimos que la entrega de las bolsas se haga mediante un sistema fácil y práctico, sin una burocracia que complique las cosas", agregó.
Fuente: Mirada Profesional
FDA Law Blog: FDA Announces Strategy for Review of Animal Food Ingredients, With Uncertain Implications for Industry
FDA Law Blog: FDA Announces Strategy for Review of Animal Food Ingredients, With Uncertain Implications for Industry
Posted: 31 Mar 2015 11:56 PM PDT
By Ricardo Carvajal & Diane B. McColl –
FDA announced a “strategy to establish ingredient definitions and standards for animal food,” pursuant to a statutory directive in the Food and Drug Administration Amendments Act of 2007 (FDAAA). As indicated in one of our prior postings, this effort has been in the works for years, but FDA’s recent announcement gives a better indication of the direction in which the agency is headed.
The stated goal of the strategy is “to align AAFCO ingredient listings with the agency’s regulatory process and requirements.” To that end, it appears that FDA intends to launch a comprehensive review through which the agency will establish as its own standards and definitions any AAFCO definitions for ingredients that are “approved by the agency as food additives” or “recognized as GRAS.” For other AAFCO definitions, FDA will review the scientific literature to determine whether that literature supports food additive approval or GRAS affirmation, and will approve or affirm those substances (apparently on the agency’s own initiative). Where data are lacking to support either of these actions, FDA will require submission of a food additive petition “to allow continued legal use” of the substance.
The planned review is reminiscent of the type of review that FDA initiated for substances used in human food in the wake of the 1958 Food Additives Amendment – a resource-intensive effort that was never completed. The planned review can therefore be expected to extend years into the future. FDA’s announcement states that “[t]he agency intends to work closely with industry during this transition to minimize disruption to animal food production.“ It’s not clear whether that close working relationship will extend to staving off a proliferation of class action litigation targeting the marketing of food ingredients under AAFCO definitions that FDA concludes are neither approved food additives nor GRAS. The marketing of such ingredients could be vulnerable to lawsuits targeting “unlawful” business practices under state law, as is feared could happen with respect to human food ingredients that FDA deems subject to a change in regulatory status (partially hydrogenated oils come to mind, as laid out in this posting by the Washington Legal Foundation).
For now, AAFCO’s new ingredient definition review process remains in operation – in fact, the Memorandum of Understandingbetween AAFCO and FDA that facilitates that process was recently renewed. If anything, AAFCO suggests that demand for its new ingredient definition review process is expected to increase as a result of FSMA, and that the MOU will help AAFCO accommodate that increased demand. At this time, it’s not clear how FDA will manage the strain of that increased demand on CVM’s resources, or how the continuation of AAFCO’s new ingredient definition review process will be squared with the planned review announced by FDA.
FDA announced a “strategy to establish ingredient definitions and standards for animal food,” pursuant to a statutory directive in the Food and Drug Administration Amendments Act of 2007 (FDAAA). As indicated in one of our prior postings, this effort has been in the works for years, but FDA’s recent announcement gives a better indication of the direction in which the agency is headed.
The stated goal of the strategy is “to align AAFCO ingredient listings with the agency’s regulatory process and requirements.” To that end, it appears that FDA intends to launch a comprehensive review through which the agency will establish as its own standards and definitions any AAFCO definitions for ingredients that are “approved by the agency as food additives” or “recognized as GRAS.” For other AAFCO definitions, FDA will review the scientific literature to determine whether that literature supports food additive approval or GRAS affirmation, and will approve or affirm those substances (apparently on the agency’s own initiative). Where data are lacking to support either of these actions, FDA will require submission of a food additive petition “to allow continued legal use” of the substance.
The planned review is reminiscent of the type of review that FDA initiated for substances used in human food in the wake of the 1958 Food Additives Amendment – a resource-intensive effort that was never completed. The planned review can therefore be expected to extend years into the future. FDA’s announcement states that “[t]he agency intends to work closely with industry during this transition to minimize disruption to animal food production.“ It’s not clear whether that close working relationship will extend to staving off a proliferation of class action litigation targeting the marketing of food ingredients under AAFCO definitions that FDA concludes are neither approved food additives nor GRAS. The marketing of such ingredients could be vulnerable to lawsuits targeting “unlawful” business practices under state law, as is feared could happen with respect to human food ingredients that FDA deems subject to a change in regulatory status (partially hydrogenated oils come to mind, as laid out in this posting by the Washington Legal Foundation).
For now, AAFCO’s new ingredient definition review process remains in operation – in fact, the Memorandum of Understandingbetween AAFCO and FDA that facilitates that process was recently renewed. If anything, AAFCO suggests that demand for its new ingredient definition review process is expected to increase as a result of FSMA, and that the MOU will help AAFCO accommodate that increased demand. At this time, it’s not clear how FDA will manage the strain of that increased demand on CVM’s resources, or how the continuation of AAFCO’s new ingredient definition review process will be squared with the planned review announced by FDA.
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