martes, 27 de junio de 2017

Improving Provider and Patient Relationships through Health IT

IN THIS ISSUE

OTHER

Diversifying ONC’s Certification Program

For the first time, ONC has approved an industry-developed testing method for health IT that can be used in the ONC Health IT Certification Program. The National Committee for Quality Assurance (NCQA) stepped up to the call we made in 2015 inviting industry to submit test tools or procedures. Learn more about NCQA’s electronic clinical quality measure testing method that is an alternative to the government supported Cypress method in a new blog post.

Health IT Playbook + HealthFinder.gov Unite

The Health IT Playbook added myhealthfinder, a tool that provides patients with personalized recommendations for preventive services based on age, sex, and pregnancy status. This resource, developed by the HHS Office of Disease Prevention and Health Promotion (ODPHP), provides health care professionals with tools to empower patients with easy to understand health information. Read the latest buzz blog post: Trusted Content from HealthFinder.gov Can Improve Patient Portals

One Click Scorecard

ONC's benchmarking tool called the “One Click Scorecard” tests both Direct transport and C-CDA conformance. To use it, a health care provider (with a DirectTrust accredited HISP) needs to do one thing: send a C-CDA (via Direct) to scorecard@direct.hhs.gov. In a few moments, the benchmarking tool will test the C-CDA and respond back to the sender’s Direct account with a PDF “report card” that includes scoring information about the C-CDA. Once a C-CDA is tested and scored, the entire C-CDA along with any PHI is immediately erased and is not retained. For more information and to read the full notice regarding the disclosure of PHI, visit the One Click Scorecard.

Reminder: Proposed Interoperability Standards Measurement Framework Open for Public Comment

ONC is now accepting public comments on the Proposed Interoperability Standards Measurement Framework. We are looking for feedback on a proposed industry-wide measurement framework for assessing the implementation and use of health care interoperability standards and implementation specifications. Currently, the capabilities to measure and report on the use of standards vary significantly across the health IT ecosystem. This framework aims to help health IT developers, health information exchange organizations, and health care providers move towards a set of uniform measures to assess interoperability progress. Learn more by reading the latest ONC blog post Wanted: Feedback on Ways to Measure the Implementation and Use of Interoperability Standards.

Public comments on the Proposed Interoperability Standards Measurement Framework will be accepted until 5pm ET on Monday, July 31, 2017. Please note that comments and recommendations submitted as part of this process will be made public by ONC.

OTHER HEALTH IT UPDATES

CMS Proposes Quality Payment Program Updates to Increase Flexibility and Reduce Burdens

Last week, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would make changes in the second year of the Quality Payment Program as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The proposed rule would amend some existing requirements and also contains new policies for doctors and clinicians participating in the Quality Payment Program that would encourage participation in either Advanced Alternative Payment Models (APMs) or the Merit-based Incentive Payment System (MIPS). The proposed rule (CMS-5522-P) can be downloaded from the Federal Register.

Draft Telehealth Measurement Framework Report Available for Comment

The National Quality Forum (NQF) draft report entitled: Creating a Framework to Support Measure Development for Telehealth is available for public comment through June 30 at 6:00 pm ET. The framework is intended to identify existing and potential telehealth metrics to identify gaps and develop a measure framework, a prioritized list of measure concepts, and guiding principles for future telehealth measurement.

NQF invites comments on the body of the report as well as suggestions for specificity around the measure concepts. You will need to log in to the NQF website to submit comments. Please contact the NQF project team with any questions.

Dra. Marisa Aizenberg: Se crea el Programa Nacional de Cáncer Bucal (PRONACABU)

Se crea el Programa Nacional de Cáncer Bucal (PRONACABU)

Posted: 27 Jun 2017 08:28 AM PDT

Resolución 754 - Ministerio de Salud de la Nación

Título: Salud. 'Programa Nacional de Cáncer Bucal (PRONACABU)'. Creación.

Fecha B.O.: 26-jun-2017

Texto de la norma:

Visto el Expediente N° 1-2002-8662/16-0 del registro del MINISTERIO DE SALUD, y

CONSIDERANDO:

Resultado de imagen para salud bucodental

Que desde este Ministerio, resulta ineludible coordinar acciones con los sistemas de salud provinciales y municipales, con el objetivo de contribuir a mejorar las condiciones socio sanitarias de la población, priorizando el trabajo con los sectores en situación de mayor vulnerabilidad de nuestro país.

Que entre los objetivos principales de la SUBSECRETARÍA DE PROGRAMAS DE PROMOCIÓN, PREVENCIÓN Y ATENCIÓN PRIMARIA se encuentra el de entender en los aspectos relacionados con la salud Buco-Dental.

Que asimismo constituyen objetivos de la DIRECCIÓN NACIONAL DE SALUD BUCODENTAL, proponer, desarrollar y controlar las acciones de promoción, prevención, asistencia y rehabilitación de la salud bucodental, de manera eficiente, equitativa y solidaria, con el objeto de reducir la morbilidad por enfermedades bucodentales y mejorar la calidad de vida de la población más vulnerable a fin de lograr una mayor inclusión social con equidad.

Que una gran parte de la población mundial, desconoce la existencia del cáncer en la cavidad bucal, recibiendo los servicios de Patología Oral aquellos pacientes que llegan a la consulta con cánceres en etapas ya muy avanzadas, debido a su propia desinformación o bien por tratamientos ineficaces motivados en diagnósticos equivocados.

Que de acuerdo a datos estadísticos solo el QUINCE POR CIENTO (15%) de los casos son detectados en etapas tempranas, mientras que el OCHENTA Y CINCO POR CIENTO (85%) restante, la detección ocurre en períodos avanzados.

Que la tasa de mortandad para el cáncer de la boca es más elevada que aquella que corresponde a la enfermedad de Hodkgkin, al cáncer cervicouterino, al cáncer cerebral, hepático, testicular, renal, de ovario o cutáneo (melanoma maligno).

Que en Argentina se detectan TRES MIL (3000) casos nuevos por año de cáncer bucal, de los cuales fallecen entre OCHOCIENTOS (800) y MIL (1000) enfermos en el mismo período, representando así aproximadamente DOS (2) personas fallecidas por día por cáncer bucal.

Que por lo expuesto se propicia la creación de un programa, que tenga continuidad, más allá de las circunstancias participantes, cuya orientación debería acentuar el enfoque especialmente en poblaciones vulnerables que carecen de cobertura alguna de obras sociales, sindicales o prepagas, sin perjuicio de lograr una llegada a la totalidad de la población con el mensaje.

Que, el Programa a crear articulará con el INSTITUTO NACIONAL DEL CÁNCER lo que respecta a registros de lesiones precancerosas y cáncer bucal.

Que, en consecuencia el Programa que se crea por la presente será denominado "PROGRAMA NACIONAL DE CÁNCER BUCAL (PRONACABU)".

Que la DIRECCIÓN GENERAL DE ASUNTOS JURÍDICOS ha tomado la intervención de su competencia.

Que la presente medida se dicta en ejercicio de las atribuciones emergentes de la Ley de Ministerios - T.O. 1992, modificada por Ley 22.520 modificatorias y complementarias.

Por ello,

EL MINISTRO DE SALUD

RESUELVE:

Artículo 1.- Créase el "PROGRAMA NACIONAL DE CÁNCER BUCAL (PRONACABU)", en el ámbito de la DIRECCIÓN NACIONAL SALUD BUCAL de la SUBSECRETARÍA DE PROGRAMAS DE PROMOCIÓN, PREVENCIÓN Y ATENCIÓN PRIMARIA de la SECRETARÍA DE PROMOCIÓN DE LA SALUD, PREVENCIÓN Y CONTROL DE RIESGOS, y bajo dependencia directa del Titular de dicha Dirección Nacional.

Artículo 2.- El Programa creado por el artículo anterior tendrá entre sus objetivos prioritarios los siguientes:

a) Disminuir la morbimortalidad por cáncer bucal en la REPÚBLICA ARGENTINA.

b) Establecer un Registro Nacional de lesiones precancerosas y cáncer bucal.

c) Crear una red asistencial capacitada para el reconocimiento temprano de las lesiones precancerosas y cáncer bucal en todo el ámbito nacional.

d) Establecer una comunicación directa con la población a través de un 0800 que permita evacuar dudas sobre los temas de la campaña.

e) Informar sobre medidas preventivas del cáncer bucal en charlas comunitarias (prioritariamente se dirigirá a adolescentes que son quienes comienzan con hábitos como el consumo de tabaco y de alcohol).

f) Instruir a la población, a través de charlas y medios audiovisuales, en el autoexamen de la cavidad bucal.

g) Establecer relaciones etiológicas de acuerdo a las situaciones ecológicas y epidemiológicas de las distintas regiones del país.

h) Generar en la población estilos de vida sanos.

Artículo 3.- El gasto que demande esta actividad será solventado con las partidas específicas correspondientes a la Jurisdicción del MINISTERIO DE SALUD, de acuerdo a lo establecido por el Presupuesto General para la Administración Pública Nacional, bajo imputación: Programa 41- Actividad 08 - PROMOCIÓN Y ATENCIÓN PRIMARIA DE LA SALUD BUCODENTAL.

Artículo 4.- Comuníquese, publíquese, dése a la Dirección Nacional del Registro Oficial y archívese.-

Jorge Daniel Lemus.

Drugs of Abuse (2017 Edition)

FOR IMMEDIATE RELEASE

Contact: DEA Public Affairs

(202) 307-7977

DEA Releases 2017 Drugs of Abuse Resource Guide

Guidance issued as a tool for law enforcement, practitioners, and the public

JUNE 27 - (Washington, D.C.) – The U.S. Drug Enforcement Administration today released the 2017 edition ofDrugs of Abuse, A DEA Resource Guide.

The Drugs of Abuse guide is released on a periodic basis and designed to be a reliable resource on the most commonly abused and misused drugs in the United States. The guide provides important science-based information about the harms and consequences of drug use, describing a drug’s effects on the body and mind, overdose potential, origin, legal status, and other key factors. The 2017 edition updates the 2015 Drugs of Abuse publication with the most current information on new and emerging trends in drug misuse and abuse, including fentanyl, other opioids, and synthetic drugs.

Because education plays a critical role in preventing substance abuse, this comprehensive guide is intended as a tool not just for medical practitioners and law enforcement officials, but also for educators, families, and communities. Drugs of Abuse also offers a list of additional drug education and prevention resources, including the DEA websites: www.DEA.gov, www.getsmartaboutdrugs.comfor parents, www.justthinktwice.com for teens, and www.operationprevention.com for teachers.

For more information and to view the 2017 Drugs of Abuse resource guide, visithttps://go.usa.gov/xN7Qm.

Connect with Employers at the July 18th Virtual Job Fair

NHSC Virtual Job Fair

Tuesday, July 18

6:45 p.m. – 10:15 p.m. ET

Register Now

Join the Virtual Job Fair to connect and network with prospective employers and find job vacancies in all NHSC and NURSE Corps eligible disciplines from the comfort of your own home.

The Virtual Job Fair offers real-time interaction with representatives from National Health Service Corps (NHSC) sites and NURSE Corps critical shortage facilities.

Don’t miss this opportunity to learn about job openings, site information, benefit packages, and populations served to get your questions answered.

To participate you need to:

Have access to a computer, smartphone or other mobile technology with access to the Internet, and a phone line the day of the job fair
Be seeking a medical, dental, or mental and behavioral health position

Space is limited! Learn more about the Virtual Job Fair and register today.

Questions? Contact us at NHSCVirtualJobFair@hrsa.gov.

To search additional job vacancies, check out the NHSC Health Workforce Connector.

Register Now

For more information, please visit the NHSC Virtual Job Fair web page or email us at NHSCVirtualJobFair@hrsa.gov

What’s New for Biologics

What’s New for Biologics

fda header

What's New

https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WhatsNewforBiologics/default.htm

What’s New for Biologics

Summary of Safety and Effectiveness - Elecsys HIV combi PT (PDF - 297KB)
Posted: 6/27/2017

CMS issues updated county by county analysis of current projected issuer participation in Health Insurance Exchanges

Centers for Medicare & Medicaid Services

CMS NEWS

For Immediate Release
June 27, 2017
Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries

CMS issues updated county by county analysis of current projected issuer participation in Health Insurance ExchangesIssuer participation in the Exchanges continues to decline

The Centers for Medicare & Medicaid Services (CMS) is releasing an updated county-level map of projected issuer participation on the Health Insurance Exchanges in 2018 based on the known issuer public announcements through June 27, 2017. This updated map shows that coverage choices on the Exchanges continue to disappear week to week. Plan options are projected to be down from last year and, and in the last two weeks Americans in four additional counties are projected to have no coverage options available to them on the Exchanges.
“We continue to see a decline in issuer participation in the Health Insurance Exchanges leaving consumers with fewer and fewer insurance options,” said CMS Administrator Seema Verma. “I am deeply concerned about the crisis situation facing the individual market in many states across the nation.”
The CMS map displays projected individual market Exchange coverage based on Plan Year 2018 announced issuer exits and entrants. Participation is expected to fluctuate and does not represent actual Exchange application submissions. It currently shows that nationwide issuer participation continues to decline and that 49 counties are projected to have no issuers, meaning that Americans in these counties could be without coverage on the Exchanges for 2018. It’s also projected that as many as 1,300 counties - over 40 percent of counties nationwide – could have only one issuer in 2018. This could represent as many as 2.4 million Exchange participants that won’t have any choice and may not be able to receive the coverage they need. Currently for 2018, at least 36,000 active Exchange participants live in the counties projected to be without coverage in 2018.
CMS continues to work with state departments of insurance and issuers to address bare counties, exploring all options available under current law to provide Americans with access to coverage.
Issuers are still in discussions with their respective State Departments of Insurance to discuss rates, participation, and whether they intend to expand or retract their current county level coverage. The final deadline for issuer changes to the Qualified Health Plan applications for the Federally-facilitated Exchanges is August 16, 2017. In addition, issuers have until September 27, 2017 to sign their final QHP agreements.
The Department of Health and Human Services (HHS) is committed to doing everything permitted under current law to provide patients with immediate relief from damage the Exchanges has done to the individual and small group health insurance markets. HHS actions are intended to stabilize the markets, increase choices, and lower costs. You can learn more by visiting hhs.gov/relief.

FDA Law Blog: GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees

GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees

Posted: 27 Jun 2017 09:12 AM PDT

By Kurt R. Karst –

In a new report issued earlier this week, titled “Generic Drug User Fees: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees,” the U.S. Government Accountability Office (“GAO”) examines several aspects of FDA’s implementation of the first iteration of the Generic Drug User Fee Amendments (“GDUFA”). Responding to an inquiry from the U.S. Senate Committee on Health, Education, Labor, and Pensions, the GAO: (1) examines how user fees supported FDA’s generic drug program; (2) describes FDA’s improvements to the generic drug application review process; and (3) analyzes changes in generic drug application review times. In an appendix to the report, GAO also includes a discussion of the various regulatory science initiatives funded under GDUFA and identified in the GDUFA I Commitment Letter.

Overall, the GAO found that GDUFA user fee funding has been used well to improve FDA’s generic drug program. “FDA has used its user fee funding to enhance OGD’s ability to increase hiring, and undertake numerous activities to improve and speed-up the review of generic drug applications,” says the GAO. These improvements are apparent in decreased first cycle ANDA and Prior Approval Supplement (“PAS”) review times:

With respect to ANDA review times, the average time for FDA to complete the first review cycle decreased from 26 months for ANDAs submitted in fiscal year 2013 to about 14 months for those submitted in fiscal year 2015. . . . However, as of December 31, 2016, 929 ANDAs (34 percent) submitted since the start of the generic drug user fee program in fiscal year 2013 were still pending review. As these applications are reviewed, the average review time . . . for each fiscal year will increase since all of the applications that remained to be acted on are at least 15 months old. As of December 31, 2016, FDA had also acted on 89 percent of all ANDAs submitted in fiscal year 2015 within 15 months of receipt, exceeding its GDUFA goal of acting on 60 percent of ANDAs received in fiscal year 2015 within 15 months. . . .

For PASs, the average time for FDA to complete the first review cycle also declined from 12 months in fiscal year 2013 to 4.5 months in fiscal year 2015.

Despite the decrease in original ANDA and PAS first cycle review times, where the rubber meets the road is in approvals. As Office of Generic Drugs Director Kathleen “Cook” Uhl noted earlier this year only 9% of ANDAs in the Fiscal Year 2015 application cohort were approved (or tentatively approved) during a first cycle review, while 71% were the subject of a Complete Response Letter. The anemic approval figure improved to 42% (and 56% for Complete Response Letters) on a second cycle review.

The GAO’s biggest criticism of FDA’s implementation of GDUFA concerns the Agency’s lack of a plan for dealing with user fee carryover. “FDA has accumulated a large unobligated user fee carryover balance, which it uses as an operating reserve,” says the GAO. “At the beginning of fiscal year 2017, FDA had a carryover of approximately $174 million.” That figure is way down from the staggering $278 million carryover FDA had amassed by the end of Fiscal Year 2014. Nevertheless, it’s “an amount nearly as great as the annual, inflation-adjusted user fee collection amount of $299 million” established under GDUFA I, notes the GAO.

Despite the large carryover amounts, FDA has not developed a planning document on how it will administer its carryover—one that includes a fully documented analysis of program costs and risks to ensure that its carryover reflects expected operational needs and probable contingencies. Although FDA uses an internal management report to show GDUFA collection amounts, obligations, and end-of-year carryover amounts, the agency was unable to produce evidence describing whether the carryover of $174 million at the beginning of fiscal year 2017 (or carryover amounts in other years) was within a targeted goal, and it does not have targets for future years in general.

To deal with this lingering issue, and to “ensure efficient use of generic drug user fees, facilitate oversight and transparency, and plan for risks,” the GAO recommends that FDA Commissioner Gottlieb “develop a plan for administering user fee carryover that includes analyses of program costs and risks and reflects actual operational needs and contingencies.”