Monday, September 28, 2015

3 New Games for Your Health Literacy Toolbox!

Click on any of the games below to launch:

COPD Bowling League

Although there is no cure for COPD, there are things you can do to control your symptoms and improve your quality of life. Join the Wednesday night Bowling league to learn how to take control of COPD. Learning how to strike out an exacerbation will ultimately lead to a winning season.

How many steps will it take to walk off these fast food favorites?

Carbohydrates are an important part of a healthy diet, but there's much discussion about the good and bad carbs. So how do you know which is which? The answer is both simple and complex!

Visit mHealth Games or email to learn more...

Thursday, September 24, 2015

ICD-10: One Week Out

By Dr. Bill Rogers, ICD-10 Ombudsman

In one week, the U.S. health care system will start using the International Classification of Diseases, 10th Revision. This is a huge moment because ICD-10 will help doctors and other health care providers better:
  • Define patients’ clinical status and treat their complex medical conditions.
  • Coordinate care among providers.
  • Support new payment methods that drive quality of care.
As we come to October 1st, CMS wants to assure the medical community that we’ve tested and retested our systems, and we’re prepared to solve problems that may come up.
Because we know this is a major transition, we’ll be:
  • Monitoring the transition in real time.
  • Watching our systems.
  • Addressing any issues that come to the ICD-10 Coordination Center.
We’ll also be supporting you in four ways:
  1. If you need general ICD-10 information, we have many free resources at our Road to 10 webpage and on gov/ICD10 that can help, such as the ICD-10 quick start guide, customized ICD-10 action plans, videos, and Frequently Asked Questions.
  1. Your first line for help for Medicare claims questions is to contact your Medicare Administrative Contractor. They’ll offer their regular customer service support and respond quickly. You can find MAC contact information here.
  1. You can e-mail our ICD-10 Coordination Center, and we’ll respond to your questions.
  1. You can contact me, the ICD-10 Ombudsman. I’ll be an impartial advocate for providers, focused on understanding and resolving your concerns.
We’ve been working to help you move to ICD-10 by offering resources and flexibility, but if you aren’t ready for the transition, you still have options that will enable you to continue to provide care and be paid for your services. We recommend that you check with other payers to learn about their available claims submission alternatives.
The Road to 10 countdown clock highlights how close we are to this important milestone. If you haven’t yet started to transition, it is doable, and we encourage you to start today.

Friday, September 18, 2015

Patient Engagement Advisory Committee


The Committee will provide advice to the Commissioner or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The Committee may consider topics such as: Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device-related quality of life or health status issues, and other patient-related topics. The Committee will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It will perform its duties by discussing and providing advice and recommendation in ways such as: Identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy.

Committee Membership

The Committee will consist of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from experts who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States. Selected Committee members may also be experienced in the work of patient and health professional organizations; methodologies for eliciting patient preferences; and strategies for communicating benefits, risks and clinical outcomes to patients and research subjects. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The voting members may include one consumer representative who is a technically qualified member, selected by the Commissioner or designee, identified with consumer interests, and is recommended by either a consortium of consumer oriented organizations or other interested persons. The Commissioner or designee will also have the authority to select from a group of individuals nominated by industry to serve temporarily as non-voting members who are identified with industry interests. The number of temporary non-voting members selected for a particular meeting will depend on the meeting topic.

Contact Information

Letise Williams, Designated Federal Official
Office of Center Director
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 301-796-8398

FDA Advisory Committee Information Line

(301-443-0572 in the Washington, DC, area)
Please call the Information Line for up-to-date information on meetings