sábado, 30 de julio de 2016

REVISTA MÉDICOS - JULIO

www.revistamedicos.com.ar/medicos93.pdf



REVISTA MÉDICOS - EDICIÓN JULIO
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The Affordable Care Act Federal Upper Limits Have Been Updated

Medicaid.gov
The updated Affordable Care Act Federal upper limits (FUL) calculated in accordance with the Medicaid Covered Outpatient Drug final rule with comment are now available on the Medicaid.gov website at https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Pharmacy-Pricing.html.  States will have up to 30 daysfrom the August 1, 2016 effective date to implement these updated FULs.  
For further information on the FUL program, please see the Federal Upper Limits page athttps://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/federal-upper-limits.html.

HHS Innovation Day: Innovation is a Force For Good

Dept. of Health & Human Services

HHS Innovation Day: Innovation is a Force For Good

By: Susannah Fox, Chief Technology Officer of HHS
"We need innovation to help transform health and health care for the better and for all."
HHS Innovation Day: Innovation is a Force For Good
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Cultural Competence: Challenging Our Own Perspectives To Meet Patient Needs

Cultural Competence: Challenging Our Own Perspectives To Meet Patient Needs

SAMHSA Logo

Cultural Competence:

Challenging Our Own Perspectives To Meet Patient Needs

In a nation of constantly evolving cultural demographics, one treatment plan doesn't fit all.
Each patient entering treatment for behavioral health issues brings a unique background, and culture is a dynamic part of past experiences and current perspectives.
Structuring culturally responsive treatment strategies from an organizational standpoint requires time and commitment. In the process, counselors must expand beyond their own personal understanding of culture and the world around them.
As Minority Mental Health Awareness Month comes to an end, share the following SAMHSA resources among your colleagues to encourage cultural competence in behavioral health services around the country:
Cultural Competence: Challenging Our Own Perspectives To Meet Patient Needs

FDA Issues Draft Guidance on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Today, the U.S. Food and Drug Administration released a draft guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance clarifies how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the evidentiary standards we use to make those decisions.  It clarifies how we plan to evaluate real-world data to determine whether it may be sufficiently relevant and reliable for various regulatory decisions, and it also clarifies when an Investigational Device Exemption (IDE) may be needed to prospectively collect and use real-world data for purposes of determining the safety and effectiveness of a device.
Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients.  The draft guidance gives generalized examples taken from actual uses of real-world data as valid scientific evidence for various regulatory decisions.
This draft guidance is a cornerstone of our strategic priority of creating a national evaluation system for medical devices.  That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.
We welcome comments regarding this draft guidance. The notice of availability will be published in the Federal Register on 7/27/16, and the docket for receiving comments will be open for 90 days from that date.
If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

Opportunity to Comment: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Comment on Current FDA Draft Guidances > Opportunities to Comment Closing November 2016

The FDA is establishing a public docket and requesting comments, supported by scientific evidence, regarding potential blood donor deferral policy options to reduce the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.  
Specifically, the FDA is inviting comments on the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessment.
The FDA is also seeking comments regarding the design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options.
The FDA will consider comments and supporting scientific evidence received as it continues to reevaluate and update blood donor deferral policies.
The comment period is 120 days.
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the HIV Liaison Program visit the FDA Patient Network

New HCUP Workshop

New HCUP Workshop



The Healthcare Cost and Utilization Project (HCUP) announces an upcoming Workshop:
  • Topic: HCUP In-Depth:  A Hands on Workshop Using HCUP’s Newest Database, the Nationwide Readmissions Database (NRD)
  • Date: September 13, 2016 9:00 AM – 4:00 PM
  • Location:  AHRQ Headquarters, Rockville, MD
Information on upcoming workgroups and webinars is available at: http://www.hcup-us.ahrq.gov/hcup_web_wkshop.jsp
The HCUP family of health care databases and related software tools and products is made possible by a Federal-State-Industry partnership sponsored by the Agency for Healthcare Research and Quality (AHRQ).  Visit the HCUP User Support Web site at: http://www.hcup-us.ahrq.gov